[Senate Hearing 108-745]
[From the U.S. Government Publishing Office]
S. Hrg. 108-745
Senate Hearings
Before the Committee on Appropriations
_______________________________________________________________________
Departments of Labor,
Health and Human Services,
and Education, and Related
Agencies Appropriations
Fiscal Year
2005
108th CONGRESS, SECOND SESSION
H.R. 5006/S. 2810
DEPARTMENT OF EDUCATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NONDEPARTMENTAL WITNESSES
S. Hrg. 108-745
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
on
H.R. 5006/S. 2810
AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR, HEALTH AND
HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES, FOR THE FISCAL
YEAR ENDING SEPTEMBER 30, 2005, AND FOR OTHER PURPOSES
__________
Department of Education
Department of Health and Human Services
Nondepartmental witnesses
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/
congress/senate
__________
U.S. GOVERNMENT PRINTING OFFICE
92-155 WASHINGTON : 2004
____________________________________________________________________________
COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas MARY L. LANDRIEU, Louisiana
James W. Morhard, Staff Director
Lisa Sutherland, Deputy Staff Director
Terrence E. Sauvain, Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas HARRY REID, Nevada
TED STEVENS, Alaska HERB KOHL, Wisconsin
MIKE DeWINE, Ohio PATTY MURRAY, Washington
RICHARD C. SHELBY, Alabama MARY L. LANDRIEU, Louisiana
ROBERT C. BYRD, West Virginia (Ex
officio)
Professional Staff
Bettilou Taylor
Jim Sourwine
Mark Laisch
Sudip Shrikant Parikh
Candice Rogers
Ellen Murray (Minority)
Erik Fatemi (Minority)
Adrienne Hallett (Minority)
Administrative Support
Carole Geagley
C O N T E N T S
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Thursday, March 4, 2004
Page
Department of Education: Office of the Secretary................. 1
Thursday, March 25, 2004
Department of Health and Human Services: Office of the Secretary. 75
Tuesday, April 1, 2004
Department of Health and Human Services: National Institutes of
Health......................................................... 107
Nondepartmental Witnesses
Department of Labor.............................................. 255
Department of Health and Human Services.......................... 271
National Institutes of Health.................................... 345
Department of Education.......................................... 429
Related Agencies...........................................448
Miscellaneous..................................................??? deg.
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005
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THURSDAY, MARCH 4, 2004
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:40 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Hutchison, Stevens, Harkin,
Kohl, Murray, and Landrieu.
DEPARTMENT OF EDUCATION
Office of the Secretary
STATEMENT OF HON. RODERICK PAIGE, SECRETARY
ACCOMPANIED BY:
C. TODD JONES, ASSOCIATE DEPUTY SECRETARY FOR BUDGET AND
STRATEGIC ACCOUNTABILITY
THOMAS SKELLY, DIRECTOR, BUDGET SERVICES
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. The hearing of the Appropriations
Subcommittee on Labor, Health, Human Services, and Education
will now proceed. I regret being a few minutes late. They have
Constitution Avenue blocked off. How did you make it Mr.
Secretary?
Secretary Paige. I know some shortcuts.
Senator Specter. You must have more clout than a chairman,
Mr. Secretary.
Secretary Paige. I doubt that.
Senator Specter. We never know what's going to happen
around the Capitol from one day to the next, but Constitution
Avenue is blocked off as we came up. They publicized recently
that the Capitol is an armed camp but at least the streets were
clear, but this morning even the streets are not clear.
Well, on to the business of the subcommittee. We have the
distinguished Secretary of Education with us today, came to the
administration with an outstanding reputation as the
superintendent of the Houston Independent School District. He
served as dean of education and athletic director prior to that
at Texas Southern University. He takes on a gigantic job, has
taken on a gigantic job in the Department of Education, and
with the President on a bipartisan basis has led to the
enactment of legislation on Leave No Child Behind, which was
widely heralded in 2001 when enacted.
The President made a special trip to Massachusetts with
Senator Kennedy to show the bipartisan support. Since that
time, there have been some growing pains, which we will be
exploring in today's hearing, a call for greater flexibility
where the Department has responded so far, at least in part,
concerns about adequacy of funding, where we are trying to move
ahead with more funding.
FISCAL YEAR 2005 EDUCATION BUDGET REQUEST
The budget for the Department as asked for by the
administration is in excess of $57 billion, an increase of
$1.68 billion over last year for a 3 percent increase, and the
administration has recommended additions in very important
lines, a billion in title I, a billion in special education.
But that is possible by eliminating quite a few programs,
which, Mr. Secretary, are very popular with members, and the
Constitution gives the Congress the appropriation power,
subject, of course, to the President's signature.
So we have always worked it out in the past. We're facing a
very difficult year on discretionary spending with one half of
1 percent overall on discretionary spending. We're facing a
budget deficit in the range of $500 billion, but in Winston
Churchill's famous words, we'll muddle through, and by working
together and the relationship the Secretary has had with this
subcommittee and with the Congress in general has been
excellent and on a cooperative basis.
A group of school leaders had a meeting in southeastern
Pennsylvania earlier this week where there were many concerns
expressed about the No Child Left Behind Act, and on a last
minute basis we've invited some of the people party to that
meeting and some other Pennsylvanians to come to the hearing.
The chairman is exercising his prerogative as chairman to look
to the home State. That's not unusual in Washington, D.C., but
it's representative of a national picture.
I talked to Secretary Paige last yesterday afternoon. He
has other commitments, but we struck a time agreement, out no
later than 11:00, and we appreciate his flexibility. Mr.
Secretary, the floor is yours. We have a 5-minute rule, but it
is waived for people who can get by the Constitution Avenue
blockade.
SUMMARY STATEMENT OF HON. RODERICK PAIGE
Secretary Paige. Thank you, Mr. Chairman. I would like to
submit material for the record. I'll just provide a summary and
try to get it in in 5 minutes.
Senator Specter. Well, that's wonderful, Mr. Secretary.
NO CHILD LEFT BEHIND ACT
Secretary Paige. Thank you. Let me summarize the statement
for you. With this request, President Bush has reaffirmed his
longstanding commitment to our Nation's children. Mr. Chairman,
in the time since the No Child Left Behind Act became law, we
have made tremendous progress in building a solid foundation
for educational achievement.
From day one we've been working to provide guidance on
implementation of this comprehensive and complicated law. The
States will tell you that we've done so at a record pace. We've
entered into a historic partnership with the States. In the
first year, we hosted meetings with nearly every State to
support the development of our accountability plan. Our Teacher
Assistance Corps has visited 49 States to date, working to help
States meet the law's provisions regarding highly qualified
teachers.
We continue to provide regulatory flexibility on the law's
implementation, including the recent announcement that benefits
students learning the English language for the first time, and
also greater flexibility in testing students with disabilities.
As we continue to assess the law's impact, we must always keep
in mind what is right for the child, but also be fair to the
school.
FISCAL YEAR 2005 EDUCATION BUDGET REQUEST
Despite this important progress, we still have much work to
do. My message to you this year, Mr. Chairman, is no less
urgent than it was in years past. Federal Reserve Chairman Alan
Greenspan noted recently, and I quote: ``We need to be forward-
looking in order to adapt our educational system to the
evolving needs of the economy and the realities of a changing
society. . . . It is an effort that should not be postponed.''
The President's budget proposes $57.3 billion in
discretionary appropriation for the Department of Education for
fiscal year 2005. This represents an increase of $1.7 billion,
or 3 percent, over the 2004 levels, and an increase of $15.1
billion, or 36 percent, since President Bush took office in
2001. This budget request reflects the historic bipartisan
commitment of President Bush and the Congress to increase
flexibility and accountability in the use of these funds.
KEY BUDGET YEAR FOR NCLB
The 2005 appropriation will fund the 2005-2006 school year,
a critical year that will witness two significant milestones
under the No Child Left Behind law. The first, States and
school districts will begin testing all students in grades 3
through 8 in reading and mathematics in 2005-2006. With the
information provided by these annual assessments, teachers will
have the data they need to teach each student effectively and
parents will be empowered to make informed choices for their
children's education--for their educational future. The
President is proposing $410 million in 2005 to support the
assessment system developed by each State.
The second milestone is that all teachers must become
highly qualified by the end of the school year of 2005-2006.
There is no better way to improve education than putting a
highly qualified teacher in every classroom. The No Child Left
Behind Act recognizes this fact and we will continue to work
hard with States to make this a reality. The President's Budget
proposes $5.1 billion to support teachers through training,
recruitment incentives, loan forgiveness, tax relief. This is
up from $4.4 billion in 2004 and this is a historic number.
TITLE I GRANTS TO LOCAL EDUCATIONAL AGENCIES
For students who most need our help, the President has
again proposed a billion dollar increase in title I, which
brings it up to $13.3 billion. Many of these children are on
the wrong side of a staggering achievement gap with their more
advantaged peers, often struggling in school and also in life.
We know that this problem can't be solved in Washington. Local
communities know best what to do in order to remedy these
conditions.
HISTORIC LEVELS OF RESOURCES AND FLEXIBILITY
So to help schools and districts better meet the needs of
these students, we're providing resources that are historic in
their scope and also in their flexibility, and we're asking for
annual progress assessments in return for this historic
investment.
In conclusion, when the President said in his State of the
Union address: ``We've not come all this way . . . only to
falter and leave our work unfinished.'' I took that message to
heart. In the last 3 years, we've witnessed some of the most
important milestones yet in education reform, and I believe
that one day we're going to look back at this year and see it
as a turning point in the educational culture in our country.
PREPARED STATEMENT
Fifty years ago, the historic Brown v. Board of Education
decision began to break down the barriers that prevented some
of us from attending classrooms--certain classrooms. But we
know now access was not enough. We still have a long way to go
to ensure achievement. We believe that today, at the start of
the third year of the No Child Left Behind Act, we are closer
to making that goal a reality than ever before.
Mr. Chairman, thank you, and I'd be pleased to respond to
any questions that you might have.
[The statement follows:]
Prepared Statement of Hon. Roderick Paige
Mr. Chairman and Members of the Subcommittee: Thank you for this
opportunity to testify on behalf of President Bush's 2005 discretionary
request for the Department of Education. As all of you know, the effort
to control spending while fighting a war on terrorism and ensuring
homeland security forced the President to make some tough decisions in
his 2005 budget. The significant overall increase requested for the
Department of Education shows that the President remains committed to
the vision of No Child Left Behind--that all children can learn, and
all children deserve the opportunity for a quality education.
A KEY YEAR FOR NO CHILD LEFT BEHIND
Fiscal year 2005 is a critical year for No Child Left Behind. The
2005 appropriation will fund the 2005-2006 school year, a year that
will witness two significant milestones under the new law. First,
States and school districts will begin testing all students in grades
3-8 in reading and mathematics. This is a necessary step toward giving
teachers the data they need to teach effectively and parents the
information they need to assess the progress of their children's
education.
Second, all teachers must be highly qualified--as defined by States
in accordance with the law--by the end of the 2005-2006 school year.
Research tells us there is no better single way of improving education
than by putting a highly qualified teacher in every classroom. The No
Child Left Behind Act recognized this fact, and we'll be working hard
with States to make it a reality.
We also continue to explore ways to provide the additional
flexibility that States and school districts need to effectively
implement No Child Left Behind. In December, the Department published a
new regulation giving States greater flexibility in testing students
with disabilities. Two weeks ago, I announced two new policies
governing the treatment of limited English proficient students in the
State accountability systems required by No Child Left Behind. And we
are working on some clarifications regarding the law's requirement that
all teachers be highly qualified.
In these and other instances, we believe the law is sufficiently
flexible to accommodate the legitimate concerns of State and local
educators, without undermining the core goal that all students and all
student groups must reach proficiency in reading and mathematics.
MAJOR PROGRAM INCREASES
The President's budget proposes $57.3 billion in discretionary
appropriations for the Department of Education in fiscal year 2005.
This represents an increase of $1.7 billion, or 3 percent, over the
2004 level, and an increase of $15.1 billion, or 36 percent, since
President Bush took office in 2001.
As was the case in the President's previous education budgets, most
new resources are dedicated to three major programs that form the
cornerstone of the Federal role in education. For the Title I Grants to
Local Educational Agencies program--the key driver of No Child Left
Behind reforms in the areas of accountability and parental options--the
President is seeking $13.3 billion, an increase of $1 billion over the
2004 level.
Title I helps the children who are most in need of extra
educational assistance, who are most in danger of falling further
behind, on the wrong side of the staggering achievement gap between
poor and minority students and their more advantaged peers. Our
determination to help these students--which I know is shared by the
Members of this Committee--is reflected in a request that would result
in a total increase of $4.6 billion, or 52 percent, in Title I funding
since the passage of the No Child Left Behind Act.
The President also is asking for his fourth consecutive $1 billion
increase for the Special Education Part B Grants to States program.
Under the request, funding for Part B Grants to States would rise by
$4.7 billion, or 75 percent, since 2001. The 2005 request would
increase the Federal contribution to about 20 percent of the national
average per-pupil expenditures for all children--the highest level of
Federal support ever provided for children with disabilities.
And for the need-based Pell Grants program, the budget includes an
increase of $856 million, for a total of $12.9 billion. This level
would fully fund the cost of maintaining a $4,050 maximum award and
providing grants to an estimated 5.3 million postsecondary students.
More than 1 million additional students are now receiving Pell Grants
than when the President took office.
JOBS FOR THE 21ST CENTURY
In addition to these major programs, another priority in the
Department's request is a package of proposals, totaling $333 million
in new resources, which play a key role in President Bush's Jobs for
the 21st Century initiative. These proposals would help ensure that
middle- and high-school students are better prepared to succeed in
postsecondary education and the workforce. They focus on improving
instruction to ensure students are performing on grade level in reading
and mathematics and on increasing the rigor of secondary school
curricula.
A key proposal, for example, is $33 million for new Enhanced Pell
Grants for State Scholars, which is included in the overall request for
Pell Grants. We know students who complete a rigorous curriculum are
more likely to pursue and succeed in postsecondary education, so this
proposal would provide an additional $1,000 for postsecondary freshmen
who took challenging courses in high school.
The Jobs for the 21st Century initiative also includes $100 million
in new funds to help struggling readers at risk of dropping out of
secondary school and $120 million to improve the math skills of
secondary school students who are performing below grade level. Another
$28 million in new funds is provided to help expand Advanced Placement
courses for low-income students, and $40 million is set aside for
Adjunct Teacher Corps to bring professionals with sought after
knowledge into the classroom.
The request for Vocational Education complements Jobs for the 21st
Century by proposing a $1 billion Secondary and Technical Education
State Grants program that would promote local partnerships between
community colleges and high schools to improve academic achievement and
transitions to the workforce. This request includes $12 million to help
those States that do not currently have State Scholars programs to
establish such programs.
Jobs for the 21st Century also emphasizes research-based
approaches, the importance of which is reflected in our $185 million
request for Research, Development, and Dissemination. This is an
increase of $19 million, or nearly 12 percent, to fund research on
reading comprehension, mathematics and science education, and teacher
quality.
OTHER PRIORITIES
The 2005 request provides new funding in other ongoing priority
areas, such as reading, expanding choice options, and support for
postsecondary institutions serving large percentages of minority
students.
Funding for Reading First would grow by $139 million, or more than
12 percent. Reading first offers children in grades K-3 the benefits of
research-based, comprehensive reading instruction designed to help meet
the President's goal that all children read on grade level by the end
of third grade. The request includes $1.1 billion for Reading First
State Grants, an increase of $101 million or 10 percent over last year,
as well as $132 million for Early Reading First, an increase of $38
million or 40 percent.
Our budget also reflects President Bush's determination to extend
educational options to all parents and students--not just those who can
afford this freedom. No Child Left Behind has greatly expanded the
choices available to students in low-performing schools, including both
the option to transfer to a better school and to obtain supplemental
educational services from a private-sector provider. And this fall we
will for the first time provide federally funded opportunity
scholarships to low-income students in the District of Columbia.
The President's 2005 budget would build on these achievements by
investing an additional $113 million in expanding choices for students
and parents. This total includes $50 million for a Choice Incentive
Fund that would support new transfer options, including private school
options, and a $63 million increase for the Credit Enhancement for
Charter School Facilities program, which encourages greater private
sector lending to finance academic facilities for charter schools.
Finally, our request reflects the President's ongoing commitment to
postsecondary institutions that serve large numbers and percentages of
minority students. We are asking for a total of $515 million for these
institutions, an increase of almost $21 million, or 4 percent, over the
2004 level. The total includes $241 million for Strengthening
Historically Black Colleges and Universities, $59 million for
Historically Black Graduate Institutions, and $96 million for Hispanic-
Serving Institutions.
MANAGEMENT IMPROVEMENTS
Another thing that I am proud of is the very real improvement we
have made in managing the Department and its programs. I knew when I
came to the Department that if we were going to demand stronger
accountability from States, school districts, and schools as part of No
Child Left Behind, we would have to demand that same kind of
accountability from ourselves. This has been a major priority for me
and my senior officers for the past three years, and I am pleased to
report that thanks to a lot of hard work and discipline, taxpayers can
rest assured that their hard-earned tax dollars are managed responsibly
at the Department of Education.
Fiscal year 2003 marked the second consecutive year that the
Department received an unqualified ``clean'' opinion from its financial
auditors. That may not seem like something worth celebrating, unless
you know that the 2003 opinion was only the third ``clean'' audit in
the Department's 24-year history.
We also are continuing to make progress in all areas of the
President's Management Agenda. Earlier this year, the Office of
Management and Budget announced that the Department received a major
upgrade on financial performance--moving from a RED to GREEN status
score. Our performance is ranked in the top one-third of all government
agencies, and reflects our continued determination to inject
accountability into everything we do here at the Department of
Education.
CONCLUSION
The President's 2005 budget request for the Department of Education
demonstrates his ongoing commitment to investing in educational
excellence and achievement. But it also reaffirms that the Federal role
in education is not just about money, but more importantly about
leadership based on high standards, accountability, and the use of
proven educational methods. Only in combination with this leadership--
exemplified by the No Child Left Behind Act--will the resources
provided by the Congress have the impact we have all hoped for over the
past four decades.
We still have a long way to go before we ensure equal educational
opportunity for disadvantaged children, but I believe we are witnessing
the turning point. With your help, we'll keep turning in the right
direction.
Thank you, and I will be happy to take any questions you may have.
NEW FLEXIBILITY UNDER NCLB REQUIREMENTS
Senator Specter. Well, thank you very much, Mr. Secretary.
There have already been some significant changes made in the
Leave No Child Behind program according to media reports.
Secretary Paige, could you tell us a little bit about those
changes which have already been made to add flexibility and the
reasons for those changes?
Secretary Paige. Yes. Let's kind of put this in
perspective. It's been about 8 months since school systems
began to really exercise the tenets of the No Child Left Behind
law, so we can see the impact of it. The first began in
September and October just after the accountability plans were
approved in June. Accountability programs were approved in
June; in September, October, and November, we began to see the
impact of these plans.
In October, late October, we assessed what had happened in
September and October. We were particularly interested in where
the hot spots were or the areas of difficulties that could be
found. We began then to assess those difficulties and say, for
which of these difficulties do we have regulatory ability to
provide more flexibility?
The first was special education because we found it was
having--giving us the most heartburn at that point. And so in
December we announced some new flexibility, new flexibility
with special education. The next one was LEP--limited English
proficient students. Our policy people and our legal people
studied the LEP issues, they conferred with Congress, they
conferred with the White House, and we found ways that we could
agree that we could provide more flexibility for LEP students,
and so in February we announced new flexibility in
accountability requirements for LEP students.
The third challenge was the highly qualified teacher
requirement, and the progress is ongoing now in developing some
new latitude in the highly qualified teacher requirement; all
of this within the confines of the law. And we hope in the next
10 days or so to be able to announce some new flexibility with
the highly qualified teacher requirements.
Following that, we hope that we'll be able to take a good--
we are in the process now of taking a good look at the 95
percent participation requirement to see if there's any way
there that we can find new flexibility in the law.
So there's been a constant march towards providing
flexibility to the people who really are going to have to get
this done, and those are the people who are at the schools and
in the superintendent's office and in the classrooms.
REGULATORY FLEXIBILITY FOR SPECIAL EDUCATION AND LEP ASSESSMENTS
Senator Specter. Mr. Secretary, let me shift focus just a
little bit on the issue of No Child Left Behind. Earlier this
week, last Monday, more than 100 school superintendents from 14
Pennsylvania counties met to discuss the No Child Left Behind
law and they signed a petition supporting changes, including
flexibility in testing requirements for special education and
limited English proficient students, and also full funding for
the No Child Left Behind Act. Would you direct your attention
to the issues of increased flexibility for special education
and limited English proficient students?
Secretary Paige. Yes, thank you, Mr. Chairman. Let's start
with the point of view that the philosophy of the No Child Left
Behind Act is that every student is a concern to us and the law
should provide the same kind of protection for every single
student. There are some students who bring different challenges
to us. Students with disabilities are one of those groups of
students. We want to make sure that students with disabilities
are assessed just like the other students. The law, in fact,
requires it.
What we did in December was to announce an initiative that
provided a little flexibility there, but yet kept the spirit of
the law that Congress had in mind, Congress' intent, which was
that every student is assessed. And so we announced some
flexibility such that students with the most significant
cognitive disabilities could be assessed against alternate
achievement standards. That would be limited to 1 percent of
the students tested, which could be 8, 9, 10, 11 percent of the
students with disabilities overall.
We also indicated that if a particular school district
finds that that 1 percent cap is too tight for them, and
they've got a way that they can justify a need for it to be
expanded, a process is put in place so that it can be expanded.
So the special ed regulations we think are going to provide the
kind of flexibility that school districts need in order to get
the job done.
Senator Specter. Do you think that would be enough to
account for students who are not proficient in English and also
those who need special education, Mr. Secretary?
Secretary Paige. Especially in special education. Now about
those students that have limited proficiency in English, we
indicated that the test that they're measured with would be a
test to measure where they are in that progress to English
proficiency, not a content test. Now, that's the law, but many
States have different laws that require different kinds of
approaches to that.
SINGLE SEX EDUCATION
Senator Specter. Mr. Secretary, I notice in this morning's
media reports a shift in policy by your Department on single
sex education and it is in the formative stage. And there was a
comment by Superintendent Vallas of the Philadelphia School
District, which we will be inquiring into when he testifies
later, that there's going to be a very careful examination of
community response on that issue.
But I'd be interested in your professional judgment as to
the advantages and disadvantages, and before you start to
answer the question, let me say that that's my last question,
because I want to stay within the 5-minute rule because we have
so many witnesses later. But I'd be interested in your
professional judgment on that issue.
Secretary Paige. We would like to provide broad flexibility
in the kind of systems that we have in schools for the
education of children. There's no coercion here. What we're
trying to do is to provide options for parents and for those
who administer schools. If they decide that a single-sex school
or a single-sex classroom brings the kind of advantages that
they need in order to accomplish their educational goals, we
don't want to restrict that. And so what we are attempting to
do now is to provide that kind of flexibility.
We were in New York at the Young Women's Leadership School.
I had a chance to talk to girls who felt and expressed that the
school that they were attending now gave them a really real new
lease on life. This kind of environment they thought was very
special and met their needs. They weren't required to attend
that kind of classroom, but if this is the kind of classroom
that they feel is needed there, then the ability to adapt the
structure of the delivery system should be available to the
person on the scene, and that's what we're trying to get
accomplished.
Senator Specter. Thank you very much, Mr. Secretary. I'll
turn now to, in order of arrival, Senator Landrieu.
STATEMENT OF SENATOR MARY L. LANDRIEU
Senator Landrieu. Thank you, Mr. Chairman. I have a longer
statement I'll submit to the record and, welcome, Secretary
Paige. Just for the--briefly though this morning, just say
after looking and studying very closely at this budget, Mr.
Secretary, I must say, and to the administration, that this
budget is wholly inadequate to support the education reform
efforts that are underway in this country at our own urging.
Together we set out on a path to help our States and help
our cities and help our communities identify the schools and
the systems that weren't working, and then when they looked to
us to help to provide the resources to hire better qualified
teachers, to make smaller classroom sizes, to provide early
childhood education, to provide for after-school care, the
resources are not there.
Mr. Chairman, I have to say just my general comment about
this budget is that it is wholly inadequate to meet the
challenges of reform and to strengthen what we understand is a
weak economy in the United States at this time, and the only
way this economy is going to be strengthened is if we can
increase the human capacity and invest in human talent and
skill.
Senator Specter. Senator Landrieu----
Senator Landrieu. So with that----
Senator Specter. Senator Landrieu, may I interrupt you for
just a moment? While this hearing is going on, there is an
executive session of the Judiciary Committee and they need me
there for a quorum. I'm going to excuse myself for a few
minutes. When you finish your round, Senator Murray will
proceed, and if somebody else comes, they may proceed, and I
will return momentarily.
Senator Landrieu [presiding]. Thank you, Mr. Chairman, and
I'm going to be brief because I'll--Senator Murray will have an
opening statement and then I'll get back to questions, but you
know, Mr. Secretary, I have to go on record as saying I don't
know where to begin. And let me just end with one very
specific. We called our schools and some around the country
just on one specific, so I can just express and give some real
meat to the general statement I just made.
As you know, in New Orleans and Louisiana, we're 5 years
into a very strong accountability program in which we used in
some measure as a model for the Nation. But unlike the Nation,
Louisiana stepped up and tried to fund those reforms. Last
year, 35,000 children were identified in failing schools, 1,100
applied for transfers, yet only 400 were transferred because
the rest were denied because of lack of space in higher
performing schools.
So the plan that we've put in place can't work unless we
provide the resources to give them opportunities to move to
schools that are performing but they either don't have the
teachers or don't have the classrooms, yet every time we've
asked this administration for help, for classrooms, for school
construction, we've been told no, no, and no.
In Chicago, 125,000 students were eligible for transfer,
yet there was only space for 3,000 to transfer to higher public
schools. In Baltimore--I mean, in Los Angeles, 230,000 children
were eligible, yet only 100 could transfer because there's no
space. And yet in the same budget, you all provide space to
transfer to private schools, but won't help children transfer
to higher performing public schools, and the bias is clear and
it is, in my opinion, not right.
PREPARED STATEMENT
I could go on for 3 hours, but I will not. That's just one
example, and Senator Murray will have an opportunity for an
opening statement now, or questions.
[The statement follows:]
Prepared Statement of Senator Mary L. Landrieu
Mr. Chairman, again let me take the opportunity to thank you for
your leadership in this area. I am pleased to have the opportunity
today to hear from the Secretary of Education, Secretary Paige, about
the President's Budget request for Education. As I know you agree,
there are few greater investments that can be made in the future of
this great country than the investment we make in our children's
education. For this reason, I remain committed in my support of a
budget that not only reflects national priorities in education, but
also invests in them. I am sad to find that the budget that has been
put forward by the President does neither. I hope that this committee
can work together, as we have in the past, to address the many
shortfalls left by this budget and fully invest in our promise to leave
no child behind.
As all of us know, our nation is faced with one of the largest
federal deficits in our history. While we may disagree as to how we
have come to be in this position, there is not a member of the United
States Senate who is not aware of the need to enact fiscally
responsible policies aimed at restoring balance in the federal budget.
Most experts agree that a sound fiscal policy in times of deficit
requires limited spending in key priority areas that both increase
revenue and spur economic growth. Strategic investments in education
not only allow us to develop a strong and competitive workforce but
also help citizens to move from a life of dependence on government
support to one of individual productivity.
This is not just my opinion, these are the facts. Let me read you a
few of the most recent statistics on this point.
According to the Employment & Training Administration, a person
with a bachelor's degree earns a million dollars more over a lifetime
than a person with a high school diploma and a person with an
associate's degree will earn an average of a half million dollars more
than a person with high school diploma.
According to the Current Population Survey, those with a bachelor's
degree had less than half the unemployment rate of people with only a
high school diploma during 2000.
According to the U.S. Department of Labor, occupations requiring at
least a bachelor's degree are expected to grow 21.6 percent and those
requiring an associate's degree are projected to grow 32 percent.
Recognizing the national importance of investing in the education
of our young people, I, along with other members of this committee,
have continued to push for a federal education budget that reflects the
needs our schools have in educating our future workforce. Year in and
year out, these efforts have been met with great resistance by the
Administration. Despite this fact, this President continues to claim
education as a priority and takes credit for record increases in
education spending. Again, let the facts speak for themselves.
In the three years that Bush has been in office, discretionary
education spending has increased by a total of 14 percent. In just the
last two years of the Clinton Administration, discretionary education
spending rose by 40 percent. At the same time, since the passage of the
No Child Left Behind Act, increases in spending have been going down
while federal expectations for performance have been going up. What
this indicates to me is that this President is only committed to
investing in education reform when it is politically expedient for him
to do so. Unfortunately, Mr. Secretary, that type of leadership is not
what we need. We need a President whose promises last beyond the press
conferences and photo opportunities.
This administration also claims that any cuts that are made in
education programs are part of a overall, ``better, more efficient
government'' economic strategy. In fact, on page two of your budget
summary, Mr. Secretary, you state, that the Department of Education
supports ``the elimination of categorical programs and low-priority
activities in favor of funding through flexible State grant programs
created by the NCLB Act.'' As you may know, I was one of the 13 members
who voted in favor of an education reform bill called ``The Three
R's,'' from which President Bush derived much of his education
platform. One of the main principles of this bill was that federal
resources in education needed to be consolidated into flexible state
grant programs that reflected key national priorities. Consolidation is
something I support.
But, once again, your actions do not match your rhetoric, Secretary
Paige. Your budget does in fact call for the elimination of 38
categorical programs, such as Art in Education, Even Start, Education
Research Labs, and Drop Out prevention, but you do not, as you indicate
is your policy, shift these resources toward increases in the state
grant programs created by No Child Left Behind. Instead, for the second
year in a row, you flat fund two out of the largest, most important
NCLB state grant programs, Teacher Quality and Innovation in Education,
and recommend a level of funding for the 21st Century After School
State Grant Program that is below the level it was in fiscal year 2002.
It seems to me that the funds recouped from the elimination of these
programs went instead to create 7 new programs that are more in line
with the President's personal preferences and political agenda, such as
the Choice Incentive Fund and Striving Readers program.
Finally, Mr. Secretary, I am sad to see that despite my stated
concerns on the utility of education savings accounts for private
elementary and secondary school tuition that they are again included in
your budget. As I said last year, a $150 tax savings does not help a
single mother of two who makes $30,000 a year to afford $15,000 in
school tuition. In your testimony last year, you conceded this point.
If we are sincere about helping low-income children trapped in failing
schools, then we would be better to invest the $2.0 billion reserved
for ESAs in serving disadvantaged students, teacher quality and smaller
classes.
In summary, I am very disappointed by this budget. It is wholly
inadequate to support the reforms that are underway in every state in
the Nation at our request. We made a promise to our schools that if
they went the distance and identified failure, we would be there to
help them reform. This budget does not fulfill that promise.
STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Well, thank you, Mr. Secretary and Senator
Landrieu. I share the concerns of Senator Landrieu certainly as
I look at this budget, and I just have a few minutes because
Budget is meeting right now. I'm on that committee. But the
overall funding levels in the 2005 budget request just don't
meet the needs in our States as our States are struggling to
try and meet the mandates of No Child Left Behind that I put on
them.
I will submit my statement for the record, but I just want
to echo what Senator Landrieu said. We are really shortchanging
our students at a time when we need to invest in their
education because we know that, as all of us worry about where
the jobs are of the future, if our kids aren't educated, we're
just not going to make it.
SINGLE SEX EDUCATION AND TITLE IX
So I'll submit my statement, but I do have a number of
questions that I want to ask the Secretary while I have a few
minutes here. And the first one, during the passage of No Child
Left Behind, you will remember that we reached a bipartisan
agreement on single-sex education, and in that we said that
schools may provide single-sex programs as long as they are
consistent with applicable law, title IX and the U.S.
Constitution, and requires the Department of Education to
provide guidance on that applicable law.
That law does not direct the Department of Education to
change the title IX regulations, but yesterday you released the
new proposal to amend 30-year-old title IX regulations on
single-sex education. Current law single-sex programs allow
such programs when appropriate, but contain protections against
sex discrimination. The proposed regulations would dispense
with meaningful, anti-discrimination protections and authorize
schools to provide alternatives for girls that fall far short
of equality. In fact, I believe that the No Child Left Behind
would prohibit the adoption of the Department's new proposals.
In the press release announcing the change, you even admit
that research on students' performance in single-sex education
programs is inconclusive. It seems to me this is deja vu all
over again. In 2002 and 2003, the Department of Education spent
hundreds of thousands of dollars to form a commission to look
at title IX athletics regulations, and when it was all said and
done, thankfully no changes were made to the law due to a
strong, bipartisan, and grassroots effort to support title IX.
It seems to me that spending money and efforts on the
Department--by the Department of Education helping States
implement No Child Left Behind to close the achievement gap
would be a much higher priority than throwing out longstanding
anti-discrimination laws potentially broadening the achievement
gap for our Nation's girls and boys.
Mr. Secretary, wouldn't you agree with me that the
Department's efforts should be somewhere where we really need
them to focus on right now?
Secretary Paige. Senator, with all due respect, I
completely disagree with you. May I say first that the
administration's position on title IX was brought together
based on what the administration thought is best for the
country, not because of pressure from any group. We studied the
issue, we listened to the Nation speak, we considered all the
information that they brought up, we considered their point of
view and what we were trying to accomplish. We have great
respect for title IX and what it has brought to our Nation, and
we want to only build on that and make matters better.
So I don't want it to be viewed that the administration's
output on the title IX issue resulted from pressure groups
bringing pressure for one point of view or another.
Senator Murray. Oh, I don't think--I didn't imply that at
all. But there was strong bipartisan support to--at that time,
grassroots support that the commission listened to and ended up
supporting title IX.
Secretary Paige. Well, that's----
Senator Murray. I don't call that outside pressure groups.
I call it this country.
Secretary Paige. That was our goal, to listen to the
country, and that's why we had an outstanding panel go around
the United States and conduct hearings and listen to the
country and take that into consideration. So our listening and
taking into consideration is what brought us to the conclusion
that we came to.
NO CHILD LEFT BEHIND AND SINGLE SEX EDUCATION
With respect to single-sex schools and single-sex
classrooms, our view is that it expands opportunities for the
development and achievement of No Child Left Behind as a goal.
Many young girls--I met many of them in New York when I
attended the Young Women's Leadership School, who felt that
they were being left behind, and only were able to catch up
because of the existence of that school.
So we are, without coercion, simply trying to expand
opportunities for communities and systems who choose----
``SUBSTANTIALLY EQUAL'' CLAUSE
Senator Murray. Mr. Secretary----
Secretary Paige [continuing]. To have an environment like
that.
Senator Murray [continuing]. Let me just say that my
concern is that under your proposal you use substantially equal
rather than the protections that we have under title IX under
No Child Left Behind. The term, substantially equal, concerns
me a great deal.
Mr. Jones. Senator, the provisions in No Child Left Behind
were obviously to reaffirm the protections of the Constitution,
and the protections of the title IX statute itself, but also to
recognize that the regulations under title IX are something at
the discretion of the implementation or the implementers of the
law within the public notice and comment process.
When those regulations were originally put in place, the
limit of what was known about single-sex education was somewhat
more narrow than it is today, but it----
Senator Murray. Well, but you even in your report say that
the research is inconclusive. Mr. Secretary, I have a few other
questions. Let me just say I am deeply opposed to your
proposal.
Secretary Paige. Thank you. We would----
Senator Murray. The words, substantially equal, to any one
of us who have been through this process for a lifetime----
Secretary Paige. Senator----
Senator Murray [continuing]. Leaves us with great concern--
--
Secretary Paige. We would----
Senator Murray [continuing]. For what the future's going to
bring.
Secretary Paige. We would invite continued discussions with
you around your concern.
Senator Murray. Okay. And I would, I'd love to have you
come in and talk with me about this, but we will have further
discussions. I think the term, substantially equal, leaves many
of us very concerned.
Secretary Paige. We would welcome continued discussions.
EDUCATIONAL VOUCHER PROGRAMS
Senator Murray. All right. Let me ask you too, because the
President's budget includes funding for vouchers, which were
rejected when we had our long debates and battles throughout No
Child Left Behind. At the end of the day, No Child Left Behind
rejected vouchers, but the Bush budget again includes $50
million for the Choice Incentive Fund and $14 million for the
D.C. voucher program, when even the Senate never voted on these
programs.
I just don't understand how you can repeatedly abandon
public education by giving just 1,700 students $7,500 to attend
schools that are unaccountable to students and their families
and the Department of Education, and meanwhile we can't even
increase Pell grants for low-income students to help them,
especially at a time when we know that getting education at a
higher level is important.
It seems to me that we keep focusing on a narrow program,
just as a matter of principle rather than trying to look at
where we can put our dollars in a substantial way to help a
number of students who are struggling today. And I know you and
I disagree philosophically, but I remind you that when we
debated the No Child Left Behind Act and passed that, the
voucher discussion was an essential part of that, it was
rejected at the end of the day, Congress said no, yet we keep
seeing the Bush administration put money forward for it.
Secretary Paige. Senator, it's because we believe that it
adds to the possibility of authentic school reform. We think
that the proposals we put forth are to benefit public schools,
not to detract from public schools. We think public schools,
when bound in the kind of monopolistic organizational
structures that they operate in now, that this penalizes them
and constrains innovation and constrains creativity. And that
is why we keep pushing for broader choice. We think in an
environment with broad choice, public schools will prosper.
Senator Murray. Mr. Secretary----
Senator Specter [presiding]. Senator Murray, you're about
3\1/2\ minutes over now.
Senator Murray. Okay.
Senator Specter. How much longer would you like?
PREPARED STATEMENT
Senator Murray. Well, I have questions, a number of
questions. I'll submit my questions for the record. I would
just say that it seems to me when we have our debates within
the No Child Left Behind Act, at the end of the day we agree on
it, and then we keep seeing the budgets come back outside of
what we all agreed on, for No Child Left Behind. It leaves all
of us disconcerted.
Thank you, Mr. Chairman. I apologize for going over my
time. I will submit my questions for the record.
[The statement follows:]
Prepared Statement of Senator Patty Murray
Mr. Secretary, thank you for coming to talk with us today about the
President's fiscal year 2005 education budget request. I am concerned
about overall funding levels for education. Instead of providing real
funding for critical education programs, the President robs Peter to
pay Paul by cutting funding from some programs and adding it others,
expecting it to count as an increase. Further, the President continues
to fund unproven private school voucher schemes, but cannot seem to
fund after school programs or provide increases for Impact Aid.
In fact, the President's budget only increases NCLB programs by
$1.8 percent over the fiscal year 2004 Omnibus Appropriations bill--
shortchanging the reforms included in the bill by over $9.4 billion.
The level of Title I funding in the President's budget leaves more than
4.5 million low-income children behind. In Washington State alone, the
difference between the President's request and the promise of NCLB
means that over 27,000 low-income students will be left behind.
Currently, secondary schools only receive 15 percent of Title I funds
so we are shortchanging education at all levels when we shortchange
Title I. I was pleased that the President wants to provide funding for
math gains in secondary education, but we need to be putting real
funding into our high schools. Our high schools need increase funding
for literacy and counseling to ensure that our students have the skills
and knowledge for true access to higher education and training.
The President's budget eliminates 38 programs including dropout
prevention, elementary and secondary school counseling, smaller
learning communities, and important literacy programs like Even Start.
The President's budget request also freezes critical education
programs, which is actually a cut in funding with increasing
enrollments and other costs to run schools and programs. The President
froze funding for Impact Aid, after-school, Teacher Quality, migrant
education, and rural education. At a time when thousands of soldiers
and reservists from Washington State--more than a 130,000 from around
the country--are serving in Iraq and Afghanistan, I am shocked that
this President would level fund Impact Aid instead of increasing
funding to make sure their families are well cared for in our
communities and schools. Further, funding after school at the
President's request will mean 1.4 million students will be without a
safe, adult-supervised environment after school.
The President's budget does not fully fund our share of special
education costs, failing yet again to fulfill that commitment to our
communities, our schools and our disabled students.
Under the President's budget funding for higher education programs
continue to stagnate. The President should not punish students for
increasing college costs by not increasing Pell grants.
We know what the needs are out there. We know what works to help
our children succeed. That's why I'm so disappointed that the
President's budget shortchanges America's students, and shortchanges
our country in the long run.
Senator Specter. Thank you very much, Senator Murray.
Senator Landrieu, I understand you have 2 minutes left.
PUBLIC SCHOOL CHOICE FUNDING
Senator Landrieu. Thank you. I'm going to try to get in two
questions if I can. Mr. Secretary, to follow-up on my original
comments, in your budget you make mention of the fact that
there are 2.5 million children eligible for transfer to higher
performing schools, yet the budget only reflects a $27 million
figure for public school choice.
There is an additional $50 million for public school choice
and private school choice, but only $27 million for public
school choice. Just putting the pencil to it, at $10,000 a
student, which in some areas may be too high, some areas may be
too low, my math would say that we'd need to come up with $25
billion. So how did you all come up with the $27 million figure
to help 2.5 million children who to date have been identified
as eligible? How did we arrive at that figure?
Secretary Paige. Well, the $27 million you refer to is over
and above the dollars available under the title I allocations,
which each district has. So that is not limited to $27 million.
Senator Landrieu. But our title I, based on just the basic,
is short $160 million, just the title I under Leave No Child
Behind, and now in addition we have just in our State 35,000--
--
Secretary Paige. Is short? What do you mean by short?
Senator Landrieu. Shorted based on the commitment that this
administration made to fund No Child Left Behind.
Secretary Paige. Please explain. I'm not sure I understand.
Senator Landrieu. Well, the Leave No Child Behind Act is
about $9 billion short based on the agreement that was made, if
reforms were put in, the resources would be there.
TEACHER CERTIFICATION
But let me ask my second question. Again on teachers, one
of the points of No Child Left Behind that the White House
insisted on, and I actually agreed to with some hesitation, was
that all teachers would be certified by 2005. Now, I had 40
percent of my teachers uncertified, but I was willing to say,
okay, in 3 years we'll get them certified, and the White House
said, we'll help you do it.
I look at this budget and title II, teacher quality, is
flat-funded. So what should I tell the 40 percent of my
teachers that need to get certified?
Secretary Paige. You may say to them that this budget----
Senator Specter. Mr. Secretary----
Senator Landrieu. Could he answer the question?
Senator Specter. The time is expired, but you may answer
the question.
Secretary Paige. You may say to them that, this budget has
$5.1 billion in it to support teachers, and if the States
decide to use those dollars for certification purposes, the
flexibility is there to provide opportunities for them to do
that, and the $5.1 billion to support teachers is historic in
its level.
Senator Specter. Thank you, Senator Landrieu. Senator
Hutchison.
STATEMENT OF SENATOR KAY BAILEY HUTCHISON
Senator Hutchison. Thank you, Mr. Chairman. Mr. Secretary,
I applaud that you are coming forward with the regulations on
single-sex schools as an option for public schools to be able
to meet the needs of individual children in school districts.
This is not a mandate. This is another option. If a school
district, because of input from parents or principals or
teachers, believes that they have behavioral problems or
specific problems that single-sex classes or schools would
address, they would have the option to do it.
SINGLE SEX EDUCATION
In the Washington Post this morning, there is the picture
of Moton Elementary School that on its own decided to go to
single-sex classes in 2001--2000 or 2001--and they are now--
they were at the bottom of the achievement measures in the
District of Columbia and now they're at the top, and they
credit the opportunity to have single-sex classes for doing
that. It was 2001 that they started this program.
So yesterday you did come out with the regulations and you
will have public comment, and I know, maybe there's a
disagreement on the specific language, substantially equal, but
the purpose was to assure that you could offer classes that are
tailored to boys or girls and not have a requirement of
equality when that would defeat the purpose of offering
specialized courses.
So I applaud the effort that you are making, and this is
the language in your regulations that are proposed: Single-sex
classes will be permitted as long as they are part of an even-
handed effort to provide a range of diverse educational options
for male and female students, or if they are designed to meet
particular identified educational needs.
So, Mr. Secretary, I hope you are going to pursue this. You
have a 45-day comment period, which is expedited because if a
school district wants to offer this option, they will be able
to plan for the next school year. My question to you is this.
Are you going to have funding under the title that allows for
funding creative programs to help some of these schools
implement these single-sex schools and classes?
Let me go further and just say that Houston is already
offering in their public schools a boys school. Dallas is on
the brink of offering a girls school and the headmistress of
the finest girls school in North Texas, Hockaday School, has
said that when she retires in July of this year, she is going
to volunteer her time to create a girls school in the public
school district, Dallas Independent School District.
So I am so happy that they are going to have this chance,
and I would like to know if there will be grants available for
people who are trying to be creative and offer these options to
the people that attend public schools throughout America?
Secretary Paige. Thank you, Senator, and we are going to
move forward with this. We are now awaiting the 45-day comment
period. As soon as we receive those comments we're going to
move faster, for the issues involve other agencies. The Justice
Department was involved as well. But now it's in our court, so
you can expect that we're going to move with dispatch with
this.
Senator Hutchison. Will there also be grants available?
Secretary Paige. The answer is yes.
Mr. Skelly. Senator, money is available under the State
grants for innovative programs budget, a continuing grant
program of approximately $297 million.
Senator Hutchison. Well, thank you, because, you know, so
many schools--Secretary Paige, you visited the Young Women's
Leadership School in Harlem with me, and that school is in a
part of New York that has a very low rate of graduation and
college attendance, and in fact, since that school was created,
every graduate, every graduate has gone to college, every one.
And 60 Minutes has interviewed those girls and they have
applauded the opportunity that they have, so I just am very
pleased that you are moving forward and it can't be fast
enough.
I would say to my colleagues who are concerned about the
language, why not try it? We have had failing schools for 25
years in this country and we have had people throwing up road
blocks to innovation and creativity, so let's try and see if we
can work with this language. Nobody wants schools or classes to
be inferior for boys or girls. This is America, so let's be
creative, and I applaud your efforts in what you're doing.
It appears that my time is up, but I hope that we will
finalize those regulations so school districts will have the
option, not the mandate, to go forward with hopefully creative
grants that will give us more knowledge about the benefits that
can be given--gotten from creativity in our public schools.
Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Hutchison. Senator
Kohl.
STATEMENT OF SENATOR HERB KOHL
Senator Kohl. Thank you, Mr. Chairman. Secretary Paige,
like many of my colleagues, I am also troubled by the funding
levels in the President's budget for No Child Left Behind. We
voted for that legislation because we believed it would provide
a real chance for real reform. As you know, for the first time
schools in States would be held accountable for results and the
Federal Government promised that they would provide the dollars
necessary to help them meet the new requirements.
NO CHILD LEFT BEHIND FUNDING LEVELS
Both the President and the Congress agreed to this and
parents, teachers, principals, and administrators all expected
that we would live up to our word. But now for the third year
in a row, the President's budget falls short of the promise.
His fiscal year 2005 budget request, as you know, is $9.4
billion short of what was discussed and we believe promised
when the No Child Left Behind law was enacted.
You and the administration have stated that schools have
plenty of money to implement the laws. Let me tell you just a
little about what's happening in my own State of Wisconsin. In
2003, Mr. Secretary, Milwaukee public schools received an $8
million increase in title I funds, but the new requirements for
supplemental services and transportation for students to better
performing schools cost over $10 million. In other words, the
new mandates cost $2 million more than the total increase the
Milwaukee Public Schools received, and they had to make up the
difference. To cover the costs, they were forced to eliminate
their popular summer school program, which had served 17,000
students.
This is only one example. Across Wisconsin, school
districts are being forced to cut staff and increase class
sizes, cut music, art, foreign language education, and cut
textbook purchases. Some have even had to keep their schools
colder, believe it or not, to cut down on their heating bills,
or restrict how many pages students can print from their
computers. These are clearly not the results that we all want.
Problems exist also at the State level in Wisconsin. Our
State Department of Public Instruction is working hard to
implement the new law, but they believe they'll need more
funding to create new data systems to meet new data collection
and reporting requirements. They'll also need more funding for
technical assistance teams to help schools and districts in
need of improvement.
In a recent Washington Post op-ed, you argued that studies
show that No Child Left Behind funding is sufficient. Many
researchers, however, argue that you are underestimating the
huge new cost that schools are facing. The President himself
agreed to higher funding levels when he signed No Child Left
Behind. He agreed that those authorized funding levels were
needed to help schools succeed.
So I have a problem with people in my State who wonder what
you would say in response to the statement that I just made.
AUTHORIZATION VS. APPROPRIATION LEVELS FOR NCLB
Secretary Paige. Senator, I'm confused by the word
``promise,'' and I've asked clarification on that on many
occasions, and some have pointed out that they view the
authorizing level as a promise. And when I look up what that
really means, I found that it means that you can spend no more,
but it does not say that you must spend that much as a promise.
In fact, I've been able to identify without much effort lots of
examples where there's a difference between the appropriated
level and the authorized level, and I have found that it has
been consistent throughout various administrations, both
Democrats and Republicans, where this delta appears. And this
is the first time that I've been able to understand it being
characterized as a promise.
The second point would be that my experience as a
superintendent tells me that all these schools are under
extreme pressure as far as funding is concerned. I know what
the superintendent is doing now in Houston without even talking
to her. She is preparing their budget, and she is wrestling
with how they're going to take care of their health care costs
or how they're going to take care of the transportation cost
that is increasing.
We empathize with all of that. But that has nothing to do
with the requirements of the No Child Left Behind Act. There
was one State that even indicated that in order to meet the
requirements of the No Child Left Behind Act that they would
have to have a laptop computer for every student. I would be
pleased to have a laptop computer for every student, but it has
nothing to do with the requirements of the No Child Left Behind
Act.
The budget that the President has proposed has ample
dollars in it to meet the needs and the requirements of the No
Child Left Behind Act, and as you know, the Act has language in
it that says, if it isn't funded, it isn't required. That would
be my response to it, but I don't want to be perceived as not
being empathetic to the fact that all of these schools are
under real tight budget constraints now, and we empathize with
that. But compliance with the No Child Left Behind Act is not
responsible for many of those cost elements.
Senator Kohl. Well, the President's budget in 2005 is
$24.91 billion. The authorized--and we can debate what that
meant--the authorized level was $34.32 billion. The difference
there is almost $9\1/2\ billion. Now, I would agree with you
the authorized level was not something that was legally put in
that had to be met, but the implication was very clear to those
of us who engaged in putting together the law and signing it.
You don't put a number in there unless you have some intention
or some hope of seeing that number fulfilled.
As you know, yes, there's no legal requirement and we
understand that and you're pointing that out. But clearly there
is a perception out there, which I'm sure you can understand--
--
Secretary Paige. Absolutely.
Senator Kohl [continuing]. That we're being shortchanged,
because that was the number that we put into that law.
RELATIONSHIP BETWEEN FUNDING AND ACHIEVEMENT
Secretary Paige. Could I just briefly say----
Senator Specter. Mr. Secretary, Senator Kohl's time has
expired, but you may finish your answer.
Secretary Paige. I would just like to say very briefly that
the assumption that there is a tight link between spending and
student achievement has not been established. In fact, I can
point out very easily many places where there is a very high
average per-pupil expenditure and very low performance.
Washington, D.C. public schools would be one example. I have
examples here that I could provide for anyone who wants to have
this information. There simply does not exist this tight
correlation between those two variables.
In fact, I would go further and even say in some cases the
argument about money may even be a destructive element in that
it masks some of the real challenges that need to be discussed
and looked at, and I have evidence of that in many places. But
I don't want to be perceived as not wanting more money. I know
the school systems want more money, and that's not my argument
at all. I would like for them to have more money. My argument
is that the requirements of the No Child Left Behind Act are
sufficiently and amply funded in order to get those things
carried out.
Senator Kohl. Thank you, Mr. Chairman.
Senator Specter. We've been joined by the distinguished
ranking member, Senator Harkin.
STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Thank you, Mr. Chairman. I apologize for
being late.
WASHINGTON POST OP-ED BY SECRETARY PAIGE
I would just say, Mr. Secretary, that this budget, if
enacted, will enact in the smallest increase for education in 9
years, shortchanges title I by over $7 billion, underfunds No
Child Left Behind by $9.4 billion and eliminates programs like
school counselors, arts and education, and drop-out prevention.
There's a lot more I want to say, but just a couple of
statements I want to make here before I ask a question. You
wrote an op-ed in the Washington Post that talked about Members
of Congress: ``. . . who voted for the law and support its
ideals but now see opposition as being to their political
advantage.'' That was your statement in an op-ed piece in the
Washington Post.
Well, I hope you weren't referring to me, Mr. Secretary. I
voted for the law, I was involved in the negotiations that led
up to it as a member of the authorizing committee, but I do
have concerns about how the Department is implementing it and
how it's funding it, and these concerns come from dozens of
conversations I've had with parents and teachers from Iowa. You
visited Iowa recently. You heard the same concerns I did. Just
because I'm trying to address them doesn't mean I'm, quote,
seeking political advantage. I'm trying to represent my
constituents. That, Mr. Secretary, is what they elected me to
do.
Now, you and I have always gotten along well, Mr.
Secretary, and I respect you personally. Believe it or not, you
and the White House don't always have all the answers to all
these questions. You might learn something from people in
Congress on both sides of the aisle and sometimes from our
constituents, even those who disagree with you.
UNSPENT FEDERAL EDUCATION FUNDS
Here's one bit of advice I'll give you, Mr. Secretary. Stop
making claims that States have billions of dollars for No Child
Left Behind at their disposal that they aren't bothering to
spend. You and I both know from your own Department statistics
the States are spending the money that they get from the
Federal Government as fast as they can, and yet you wrote that
States are not fully utilizing the Federal education funds
available to them in a timely manner, allowing billions of
dollars to remain in the Federal Treasury instead of improving
the education of our children.
You know full well, Mr. Secretary, the States don't spend
Federal money as soon as it's appropriated. It takes time. It's
like the situation where you put an addition on your house. It
costs $10,000, you don't pay for it all up front. You pay
$1,000 and you may pay a little bit later on, then you pay
something at the end of the time when it's over with. Schools
work the same way. They agree to contracts but they don't write
the checks until the services are provided. You know that, and
yet you're accusing States of sitting on their money.
Our chief school officer in Iowa, Ted Stilwill, responded
in a letter to you in January and said: ``the implication that
we have let huge sums of Federal money languish, that the funds
are at our disposal to use at our discretion, or that we have
not been good stewards of the public's money is not only
unfair, but patently insulting.''
RATE OF STATE SPENDING
According to the data from your own Department, States are
actually spending their Federal money faster than expected. I
have a chart from your Department showing that as of February
20, using normal spending rates, States should still be waiting
to spend about 7 percent of their money from fiscal years 2000
and 2002. As a matter of fact, States have spent all but 6
percent.
So, Mr. Secretary, if you know that States are spending the
money faster than your own Department expects them to, why are
you criticizing them for not spending it fast enough?
Secretary Paige. Senator, I hope that I can explain that,
that's not characterized as a criticism. It is a statement of
fact that I asked our office early in December to give me a
report, and early in December they did give me a report, about
December 12 or somewhere nearby. The report they gave me
indicated that there was better than $6 billion available that
had been appropriated for various educational purposes that
went all the way back to the year 2000. In fact, there are
examples of some States who had money lapse that had been on
the table so long that it was no longer available to them. So I
was making that as a statement of fact, not as a statement of
criticism.
Senator Harkin. Well, facts are facts. They're stubborn
things. This is from your own Department, Mr. Secretary, from
your own Department.
Senator Specter. Senator Harkin, how much more time do you
think you will need?
Senator Harkin. Well, do we have another round?
Senator Specter. The Secretary has to leave at 11 a.m. and
we have six people here, some superintendents who I would like
to have him hear their testimony, but I don't want to cut you
short.
Senator Harkin. Well, I appreciate that, Mr. Chairman. This
is very, very important because the allegation has been made by
the Secretary, and I have the figures right here from your own
Department, I have these figures. Now, yes, there is $6
billion, but as I said, Mr. Secretary, they don't spend this
money as soon as they get it. They have 27 months in which to
spend this money, 27 months. Obviously they haven't obligated
yet. They're spending it as it goes out.
SPENDING RATE BY STATES OF FEDERAL EDUCATION FUNDS
Your Department expected, as I said, that 7 percent would
still be unspent. They now have 6 percent left of the total
amount of money, so they're spending it even faster than your
own Department anticipated, and yet you say, and I'm only
saying what you wrote, that they're not utilizing these Federal
education funds available to them. I don't know how you explain
this. I don't know how you explain it, Mr. Secretary. Whoever
you asked for this gave you some very, very bad advice.
Senator Specter. Senator Harkin, would it be sufficient if
the Secretary responded for the record?
Senator Harkin. Yes, I would appreciate that, and as long
as you're responding for the record, I would like to have the
Secretary respond to the fact that there is $1.5 billion cut in
the President's budget from fiscal year 2005 to fiscal year
2006, and I'd like to know where you're going to find that $1.5
billion.
Senator Specter. Will you respond for the record, Mr.
Secretary?
Secretary Paige. Yes. I'll have Todd respond to the first
point.
Senator Specter. Anything further?
Mr. Jones. Senator Harkin, the issue of draw-down----
Senator Specter. I want the response--I'm sorry, Mr.
Jones--for the record because we're very short of time so we
can honor our commitment to the Secretary to leave at 11.
[The information follows:]
Unspent Funds
President Bush and the Congress have provided unprecedented levels
of funding to implement the No Child Left Behind Act (NCLB Act). In
fiscal year 2002--the first year of implementation--funding for the
Elementary and Secondary Education Act programs reauthorized by the
NCLB Act increased by $4.6 billion, or almost 27 percent. Subsequent
increases in fiscal years 2003 and 2004 have raised the total increase
to $6.9 billion, or 40 percent, since the NCLB Act was signed into law.
Nevertheless, many critics continue to insist that the new law is
underfunded, and even cite this alleged underfunding as an excuse for
not fully meeting the law's requirements.
In this context, the Administration and the Department believed it
was appropriate to point out that States and school districts have not
yet spent very significant portions of already appropriated Federal
education funds. Our intention in publicizing the facts about these
unspent funds was not to imply any wrongdoing or negligence on the part
of State or local officials, but simply to show that there is a great
deal of money in the pipeline, with about $6 billion remaining from
2000 through 2002 and billions more available from the 2003 and 2004
appropriations. The point is especially important because these
balances contrast with the claims from some State and local officials
about the inadequacy of these record Federal appropriations increases.
The availability of this very substantial, multi-year funding for
the NCLB Act is important, because major provisions of the law are
being phased in over time. For example, States were not required to
implement the new reading and mathematics assessments in grades 3-8
until the 2005-2006 school year. Similarly, veteran teachers have until
the end of the 2005-2006 school year to demonstrate that they are
highly qualified. In this context, data showing that States and school
districts are still drawing down 2002 funds simply provides another
perspective that we believe helps demonstrate that the law is
adequately funded.
As for the Senator's concern about 2006 funding levels for Federal
education programs, I would note that outyear figures in the
President's budget are primarily for planning purposes. The Department
will begin developing its 2006 request later this spring, and that
process will provide another opportunity to address concerns about the
appropriate level of funding for fiscal year 2006.
Senator Specter. We've been joined by the distinguished
chairman of the full committee, Senator Stevens.
STATEMENT OF SENATOR TED STEVENS
Senator Stevens. Mr. Secretary, I'm very pleased to be able
to get here today so I can express my appreciation to you for
what you're doing and I think you're doing a marvelous job.
Secretary Paige. Thank you, Senator.
ALASKA'S EDUCATION CHALLENGES
Senator Stevens. Your visits to Alaska have been really a
breath of fresh air to deal with the challenges that we face in
Alaska. We have one-fifth of all the land mass of the United
States and we have over 750,000 people. We are committed to
making No Child Left Behind work in Alaska, and thanks to you
and what you've done, I think we'll be able to achieve that
goal.
Our schools want to meet the high standards set forth in No
Child Left Behind legislation and we're looking forward to
working with you even more to find ways to bring that about.
Unfortunately, as you found out, in too many of our schools
English is the second language, and also, we have too many
schools where we don't have any teachers right now because of
the lack of teachers that are willing to go to the rural areas.
Thankfully, you came up and looked and found, along with my
colleague, Senator Murkowski, Lisa, who really deserves a lot
of credit for what the two of you have done really in finding
out one of the reasons they weren't staying was because they
didn't have adequate housing. I think you found one teacher
living in a broom closet.
Secretary Paige. In a closet, yes, I did.
ALASKA NATIVE EDUCATION EQUITY ACT
Senator Stevens. Now, we're anxious to work with you and
I'm pleased that your budget contains funding for the Alaskan
Native Education Equity Act. Those programs will bring
opportunities to these native students who are out in rural
Alaska, and we will meet the requirements of this bill by tele-
education, by utilizing Internet and direct access. All of
these schools are hooked up to the Internet now. We can have
live presentations from qualified teachers with master's
degrees and Ph.D.s in our Alaska universities throughout the
State.
CAROL M. WHITE PHYSICAL EDUCATION PROGRAM
But your budget also contains continued funding for the
Carol White physical education program, that is named after my
former chief of staff who's now the longest living person after
a brain tumor operation in the world. So we are delighted. This
program really is a great joy to her to read about and I want
to thank you for that.
PHYSICAL EDUCATION AND OBESITY
One of the things I would like to ask you about--as I try
to move around the country and particularly around my State,
we're moving forward in education, we're moving backward in
obesity. Have you thought about doing anything more to bring
the concepts of physical education and discipline to our
schools to try to teach our children when they're younger about
the basic essentials of exercise and diet?
I read--we all read every day more and more stories about
how we are exceeding the world in obesity. I would hope it
would be part of the educational program that you foster as you
develop this No Child Left Behind to deal with the obesity
factors that do affect the outcome of the education that we're
seeking to give our children.
INCREASED NCLB FLEXIBILITY FOR RURAL AND SMALL SCHOOLS
Secretary Paige. Senator, thank you for inviting me to
Alaska. We learned much there, and especially about the need to
have more flexibility under the highly qualified teacher
elements of the No Child Left Behind Act. We have provided some
flexibility already, but you can expect in the next 10 days an
additional announcement that will provide additional
flexibility that is aimed primarily at helping rural and small
schools meet the No Child Left Behind Act requirements.
EPIDEMIC OF OBESITY
With respect to obesity, we're very concerned about that.
There's an epidemic of obesity, even in our young people. My
colleague, Tommy Thompson, and I are in the process of
discussing ways that we can be helpful. We are collaborating in
developing some strategies and some ways that we can try to
stem what we think is a very dangerous, very dangerous trend
that's going on now.
Senator Stevens. Well, if you need any additional
flexibility under existing law to deal with that, I hope you'll
talk to the chairman or to me, because I think that one of the
keys to the success of the No Child Left Behind Act is to
develop children that are capable of retaining their education,
and they can't do it if they're suffering from obesity, in my
opinion.
Last, I want to go on record and invite you to come back,
as a matter of fact. I was out in some villages and they told
me to stay home and send you and Lisa back.
Secretary Paige. We'd enjoy it. We enjoyed our stay there
and would enjoy going back again sometime.
Senator Stevens. Well, I'm serious. There's some other
things we'd like to work with you on to make sure this law
works. I went to the State legislature this year. We have a
strange procedure in Alaska. We speak to a joint session of the
State legislature. And I told them: ``We do not need your
request to modify this law, we need your cooperation to work
with Secretary Paige to make it work.'' So we--again, we thank
you. I think you're doing a marvelous job, Mr. Secretary.
Secretary Paige. Thank you.
Senator Stevens. Thank you, Mr. Chairman.
INCREASES IN THE FISCAL YEAR 2005 EDUCATION BUDGET
Senator Specter. Thank you very much, Senator Stevens.
Senator Hutchison asked me to point out for the record that the
President's proposal of $13.3 billion for title I grants to
local education agencies is an increase of $1 billion, or 8
percent, over last year. The proposal of $11.1 billion for
individuals with disabilities is an increase of $1 billion, or
9 percent, over last year. And the President's proposal of $73
billion for postsecondary student aid is an increase of $4.4
billion, or 6 percent over last year. And also that
historically black colleges and universities have had an
increase of 30 percent by 2005, nine such colleges in her State
of Texas, and that for Hispanic-serving institutions, in fiscal
year 2005 the request is $96 million, which is a significant
increase.
TEEN SUICIDE
Mr. Secretary, I'd like you to answer one more question for
the record and that is on the issue of teen suicide. In a
small, rural Pennsylvania county, Potter County, there were
three teenage boys who committed suicide and they did not
appear to be linked in any way except that they were troubled
youth who needed counseling.
In our committee report last year, we urged you to make
availability screening programs more widely known and to
encourage school districts to implement similar teenage
programs. We have received a report, one page, which is, I
think fairly stated, not adequate in response to that request
or that issue and I would appreciate it if you would supplement
that for the record.
[The information follows:]
Screening Programs for Teenagers
The Department is taking several steps to make school districts,
juvenile justice facilities, and community-based organizations aware of
and encourage them to use screening tests to detect depression, risk of
suicide, and other mental health disorders in teenagers.
RAISING AWARENESS OF EXISTING PROGRAMS
The Department's Office of Safe and Drug-Free Schools (OSDFS) has
worked with the Columbia University ``Teen Screen'' program
(www.teenscreen.org) to make school districts more aware of tools that
are available to screen students for depression, suicide ideation, and
other mental disorders. The Columbia Teen Screen program was developed
in 1999 by Columbia University and a range of national and community
partners to identify youth who are at risk for suicide and/or suffering
from undiagnosed mental illness, and to help them obtain appropriate
treatment. The ultimate goal of the program is to ensure that all youth
are offered a mental health check-up before graduating from high
school.
In October 2003, staff from the Columbia University Teen Screen
program made a presentation at the OSDFS National Conference. The
presentation provided conference participants with an overview of the
problem of youth mental illness; information about why it is necessary
to screen for youth mental illness; information about the Columbia Teen
Screen program, including how it has been implemented in schools and
the results; and how participants can bring this program to their own
schools. Several school representatives contacted the Columbia program
after hearing about it through the OSDFS conference.
The Department will feature the Columbia Teen Screen program on the
agenda for the April 2004 Safe Schools/Healthy Students Conference
(scheduled for April 26-30, 2004) to promote the screening program. The
Safe Schools/Healthy Students initiative is a discretionary grant
program that is jointly sponsored and funded by the Departments of
Education (ED), Health and Human Services (HHS), and Justice (DOJ), and
supports local educational agencies and communities in developing and
implementing comprehensive programs that create safe, disciplined, and
drug-free learning environments and promote healthy childhood
development.
In fiscal year 2003, ED and HHS awarded more than $161 million to
89 Safe Schools/Healthy Students grantees in communities across the
Nation. These funds support locally developed comprehensive plans that
address the following elements: (1) Safe School Environment, (2)
Alcohol and Other Drugs Violence Prevention and Early Intervention, (3)
School and Community Mental Health Preventive and Treatment
Intervention Services, (4) Early Childhood Psychosocial and Emotional
Development Services, (5) Educational Reform, and (6) Safe Schools
Policies. The mental health element of the Safe Schools/Healthy
Students comprehensive plan has a dual purpose: (1) to provide metal
health preventive services early to reduce the risk of onset or delay
the onset of emotional and behavioral problems for some children; and
(2) to identify those children who already have serious emotional
disturbance and ensure that they receive appropriate referral,
treatment, and follow-up services.
At the Safe Schools/Healthy Students Conference on April 24, 2004,
Columbia Teen Screen will present a session called ``Suicide
Prevention: Who's At Risk?'' This workshop will offer an opportunity
for Safe Schools/Healthy Students grantees and for grantees from the
HHS Youth Violence Prevention and Mental Health Targeted Capacity
Expansion Grants programs to learn more about the Columbia Teen Screen
tool. This information may be particularly helpful to any grant site
that has not already adopted a suicide risk screening tool, or is
interested in learning more about other existing screening tools.
In addition to the specific workshop about the Columbia Teen Screen
program, several of the other 232 workshops offered throughout the 3-
day Safe Schools/Healthy Students conference will address the
prevention of mental health issues in young people. For example, in
another workshop that will be offered multiple times throughout the
conference, the National Suicide Prevention Resource Center will
address current issues in the prevention of youth suicide. The Rhode
Island Department of Children Youth and Families will offer a session
about youth with mental health issues who are transitioning out of the
juvenile justice system. The National Mental Health Association will
present a session about training communities around the language of
mental health. These are just a few examples of the mental health
disorder screening and prevention issues training opportunities that
will occur at this spring's Safe Schools/Healthy Students Conference.
IDENTIFYING DISTRICTS FOR SCREENING PROGRAMS
The Department will also work with the Teen Screen program to
identify school district sites where this type of program has a
likelihood of success. Because resources are limited and as not all
communities have to have the ability to provide mental health services
to those who need them (which is a requirement of the screening
program), advocacy for such screening tests needs to be targeted
appropriately if it is to have the greatest possible effect. By way of
example, the Columbia University Teen Screen program will provide
assistance to applicants for Project SERV (School Emergency Response to
Violence) grants. Project SERV provides education-related services to
local educational agencies in which the learning environment has been
disrupted due to a violent or traumatic crisis.
Since the beginning of the 2003-2004 school year, the Department
has received requests for Project SERV funding from four school
districts in response to student suicides: Three of the four districts
experienced multiple suicides within a calendar year; the fourth
district experienced a student suicide on campus during school hours.
In each instance, the learning environment was severely impacted.
Requested services for responding to each incident consisted primarily
of student mental health screening; grief and suicide prevention
counseling; and information sessions for parents, students, and
teachers regarding suicide prevention. Columbia Teen Screen program
staff members are in contact with three of these school districts about
how their program services can help with some of the recovery efforts.
OSDFS will continue to work with Columbia Teen Screen to identify other
school districts that may be able to benefit from the program's
resources.
HIGHLIGHTING SCREENING PROGRAMS IN GRANT APPLICATION PACKAGES
The OSDFS is reviewing relevant announcements for upcoming
Department of Education grant competitions so that language about
screening programs can be included in grant application packages where
appropriate. For example, the Safe Schools/Healthy Students Initiative
(discussed earlier) published a Notice of Proposed Priority for the
fiscal year 2004 grant competition in the Federal Register on March 18,
2004. Under the proposed priority, grantees would be required to
provide for school and community mental health preventive and treatment
intervention services, which could include screening programs to detect
depression and other mental health disorders. In addition, one of the
proposed requirements for the competition is that grantees and their
local public mental health authority sign a memorandum of agreement in
which the local public mental health authority must agree to provide
administrative control and/or oversight of the delivery of mental
health services. This agreement also must state procedures to be used
for referral, treatment, and follow-up for children and adolescents
with serious mental health problems. Accordingly, we will include
guidance in the application package to urge applicants to consider
including screening for depression and other mental health disorders in
their overall comprehensive plan.
ADDITIONAL STEPS
Over the next few months, we will pursue additional steps in this
area. For example, we have discussed coordinating the Department's
efforts on mental health screening with the HHS Center for Mental
Health Services (CMHS). We understand that CMHS plans to support mental
health screening activities with its own funds, and there is an
opportunity to work collaboratively with them on this effort.
We will also make our Safe and Drug-Free Schools and Communities
State coordinators more aware of what mental health screenings are, how
they can be used, and the positive benefits they can have for youth so
that they can disseminate this information to school districts and
communities in their States. Toward that end, we intend to allocate a
small amount of Safe and Drug-Free Schools and Communities National
Programs funds this year to develop a short publication on mental
health screening strategies that we would publicize and make available,
for example, on the Department's world wide web site over the Internet
as well as in print.
Senator Specter. We now have a second panel and five of our
witnesses are going to be talking about the No Child Left
Behind Act, so, Mr. Secretary, if you and your two colleagues
would come up and sit on the panel here with us, it would be a
good vantage point to listen to the witnesses, and it is my
request, as you know, for you to hear what they have to say.
STATEMENT OF JAMES WEAVER, PRESIDENT, PENNSYLVANIA
STATE EDUCATION ASSOCIATION
Senator Specter. I want to move now to the introduction of
the first witness, Mr. Weaver, president of the Pennsylvania
State Education Association, coordinator for the Social Studies
Department at the State College Area School District, bachelor
of science from Lockhaven College and master's from
Pennsylvania State University. Mr. Weaver, your 5 minutes begin
right now.
Let me ask Dr. Melissa Jamula, Dr. Jim Scanlon, Dr. Marie
Slobojan, Dr. Paul Vallas, Mr. Sam Evans, and Dr. C. Delores
Tucker also to take seats at the witness table. Thank you for
joining us.
Mr. Weaver, I wanted the Secretary to hear what your
concerns are about the No Child Left Behind Act.
Mr. Weaver. Thank you, Senator Specter. I appreciate the
invitation to be here this morning to share some thoughts
regarding No Child Left Behind. I do especially want to thank
you for inviting those of us from Pennsylvania who have been
working back home in Pennsylvania to do our best to make every
school a good school and provide quality education for
everyone.
Senator Specter. This hearing responds to a meeting which
was held earlier this week in southeastern Pennsylvania, so I
called the Secretary and he graciously agreed to stay on to
hear your concerns. Nothing like having the Secretary's ear,
Mr. Weaver.
Mr. Weaver. That's correct. Well, what I'd like to share
with you really is not so much from the perspective of being
president of the Pennsylvania State Education Association but
really being a teacher and being a teacher who represents other
education support personnel folks and other teachers.
NO CHILD LEFT BEHIND ACT
Really it deals with the frustration that educators have
with the law, and quite frankly that frustration often brings
my colleagues to tears when they see what is happening not only
to their students in terms of the testing requirements but also
to the quality curriculum that they feel is being abandoned as
a result of the law.
There are a number of things wrong with the law and we
believe many of the issues can be corrected, but the problem of
a one-size-fits-all kind of approach for not only how students
learn and how they can be assessed in terms of their
proficiency, that is a fundamental flaw of the law and it's
fundamentally wrong in what the impact is on the programs that
are being taught back in our school.
Every child can learn, but also every parent and every
teacher knows that every child does not learn at the same rate,
does not achieve at the same rate, nor in the same way. I've
had teachers tell me that the pressure on their schools to meet
adequate yearly progress both in math and reading is so strong
that they're pressured really to teach little else but what is
going to be taught on the test.
We recently gathered a group of our members along with some
administrators back in Harrisburg together to discuss the law.
During the course of the discussion, several of the comments
that were made I think are revealing. One teacher said the PSSA
test is dominating my classroom. Each year as the stakes get
higher I spend more time on how to take tests than teaching my
curriculum, and for those that may not be familiar, PSSA is the
State-prescribed test in Pennsylvania that we use to
demonstrate adequate yearly progress.
Another teacher said, and this is--well, it's just
shocking--we have a gun at our heads. We must meet the
requirements but we don't have the tools or the funding to
offer the interventions that are proven to help children. Even
our vocational technical school educators point out that
they're not teaching all the important skills in many of their
programs, their vocational skills, because they're now working
to ensure that their students pass the math and reading test,
and they believe they're sending out their students with less
skills in their technology areas now than before the law was
enacted.
Probably most important is a special education student--or
teacher--said, important life skills curricula that are being
sacrificed to teach to a test that really doesn't measure the
identified goals of the IEP. But probably the most resounding
and discouraging, disheartening statement that I hear a lot
from my members is that they feel they're being set up for
failure by No Child Left Behind.
PREPARED STATEMENT
I'm mindful of my time, so I'll say that educators don't
object and do not fear accountability, but they do understand
that trying to boil down the complicated process of educating a
child to a specific test score is at best problematic, if not
downright impossible. We believe that we need to remove the
threat of No Child Left Behind and replace it with a helping
hand, replace it with things like fully-funded programs that
work, replace it with the encouragement of our teachers and our
school support professionals and our administrators----
Senator Specter. Ten seconds left, Mr. Weaver.
Mr. Weaver [continuing]. And our parents. Let's replace
that, the threat of No Child Behind, with the encouragement of
all those stakeholders in the education process.
[The statement follows:]
Prepared Statement of James R. Weaver
Good morning Senator Specter and members of the committee. Thank
you for inviting me here this morning. I especially commend Senator
Specter for inviting those of us from Pennsylvania who are doing our
best to make every public school a great one for our children. We have
worked with Senator Specter for many years, and we know that you, Mr.
Chairman, want what is best for our children.
I also commend the group of superintendents who showed great
professional leadership by holding a news conference back in
Pennsylvania this past Monday to draw attention to the failings of the
No Child Left Behind Act.
Rather than repeat what I said at the news conference Monday, I'd
like to spend my time focusing on what I'm hearing from the teachers
and school support professionals about their frustrations with the Act.
And frankly, Senators, that frustration brings many of my members
to tears when they see what is happening to their students and to the
quality curriculum that is being abandoned as a result of this law.
There are a number of things wrong with this law--some of which can
be corrected--but because it is focused on a one-size-fits-all approach
for learning and for demonstrating proficiency, it is fundamentally
flawed and it is fundamentally wrong in what it is doing to the
programs in our schools. Every child can learn, but parents and
teachers know that all children do not achieve at the same rate and in
the same way.
I have had teachers tell me the pressure on schools to meet
Adequate Yearly Progress in math and reading is so strong that they are
forced to abandon teaching anything other than what is to be tested.
We recently gathered together several of our members, along with
school administrators to discuss this law. During the course of our
discussion, one teacher said, ``The PSSA test is dominating my
classroom. Each year as the stakes get higher, I spend more time
teaching how to take tests than teaching my curriculum.'' The PSSA is
the state-prescribed test in Pennsylvania for demonstrating Adequate
Yearly Progress.
Another teacher said, ``We have a gun at our heads. We must meet
the requirements, but we don't have the tools or the funding to offer
the interventions that are proven to help children succeed.''
Our vocational-technical school educators point out that they are
not teaching all the important skills in many of their programs because
they are working to ensure that their students pass the math and
reading tests. They believe this law is causing them to send their
graduates into the work force with fewer skills now than before this
law was enacted.
A special education teacher had this to say: ``Important life
skills curricula are being sacrificed to teach to a test that does not
measure the identified goals of the IEP.''
The most resounding message that I receive from my members is that
they have been set up for failure by NCLB. And that is very
disheartening. Educators do not object to accountability. But they do
understand that reducing the complicated process of educating a child
to a specific test score is at best problematic, if not impossible.
Our National Education Association lobbyists have circulated to
this subcommittee our recommendations specific to the education budget.
I want to highlight briefly these points:
--Funds for Title I and special education must be funded at their
promised levels, and
--The programs that work to improve student learning--many of which
are eliminated by the proposed budget, must be continued and
fully funded. These include Dropout Prevention, Gifted and
Talented programs, School Counseling and Smaller Learning
Communities. They all have a track record of success.
Before I end my remarks, I must mention the sanctions portion of
the Act. Secretary Paige and his staff continually assert that the NCLB
is based upon research.
One of the remedies for schools not making AYP is to convert them
to charter schools. The law also allows for privatization of school
services.
Where is the evidence that charter schools, that for-profit
schools, that cyber schools, that private education services succeed in
improving student performance? The evidence of the success of these so-
called ``remedies'' does not exist. Yet these are the ``remedies'' for
schools not making AYP.
We believe that if this Administration were interested in improving
public schools for all children, if it were interested in making Great
Public Schools for Every Child, it would focus less on punishment and
more on what actually works.
It would provide the funds to reduce class size--especially in our
schools which serve the most-difficult to reach students. It would
provide initiatives for full-day kindergarten, and it would fully fund
Head Start.
There is indisputable evidence that these programs make a
difference in students' long-term success.
Frankly, Mr. Chairman and members of the subcommittee, I don't
believe that the No Child Left Behind Act can be ``fixed'' as long as
it is focused on punishment and abandonment and not on what will make
our schools better for every child.
Our educators want a fair opportunity to show progress in their
efforts. We need to remove the threat of No Child Left Behind and
replace it with a helping hand. Replace it with fully-funded programs
that work, and replace it with the encouragement our teachers, our
school support professionals, our administrators, our students and
their parents need to make our public schools great for every child.
Again, thank you for this opportunity to share my thoughts.
STATEMENT OF DR. MELISSA JAMULA, SUPERINTENDENT,
READING SCHOOL DISTRICT
Senator Specter. We have to turn now to Dr. Melissa Jamula,
superintendent of schools for the Reading School District.
We'll put your impressive curriculum vitae and statement in the
record. Dr. Jamula, you have 5 minutes.
Dr. Jamula. Thank you, Senator Specter, and thank you for
the opportunity to speak with you today about No Child Left
Behind. I would request that the testimony be submitted for the
record.
As superintendent of a large urban school district, I
strongly support the tenets that No Child Left Behind was
created to support. I absolutely believe that all children can
succeed and that public schools should be held accountable for
that success. I believe that every child has the right to be
taught by highly qualified teachers in a safe environment.
Those beliefs, as stated in No Child Left Behind, without
question should be the hallmarks that drive our public
education. But I also believe that there are specific mandates
within the law that undermine the spirit of No Child Left
Behind and truly discriminate against poor minority children
and the schools that serve them, and I believe that Congress'
willingness to address these mandates will be fundamental to
whether or not No Child Left Behind goes down in history as a
piece of legislation that significantly helped to improve the
quality of education by all of America's children, or as
legislation that derailed public schools.
READING SCHOOL DISTRICT
Today I would like to provide you with what I think to be a
vivid example of how one school district is struggling without
success to comply with the mandates of No Child Left Behind.
I'm the superintendent of the Reading School District in
Reading, Pennsylvania. Of the 501 school districts in
Pennsylvania, we are the fifth largest. We have a diverse
student body, 64 percent of our children are Hispanic, 19
percent are white, 15 percent are African-American, 2 percent
are Asian or other nationalities. Of our student population, 12
percent are formally identified as students in the English
language acquisition program and another 12 percent are
formally identified as special education students.
About 3 years ago, the Pennsylvania Department of Education
hired Standard & Poor's to compare data on the 501 school
districts in Pennsylvania. In order for you to understand my
grave concerns as they exist in No Child Left Behind, I need to
have you please consider these facts about the Reading School
District. Compared to the other 500 school districts in
Pennsylvania, the Reading School District ranks in the 98th
percentile for the percentage of students who are at or below
the poverty line. We rank in the 99th percentile for children
who have English as their second language. We are in the 100th
percentile for mobility.
Last year, the Reading School District had 16,280 students.
From the time we opened our doors in September until May 1,
over 8,000 students either enrolled or disenrolled from one of
our schools. We rank in the 100th percentile for our dropout
rank. We rank only in the 1st percentile for adults in the
community with a high school diploma, and conversely, in the
99th percentile for single-parent households.
We have a very needy student and community population, but
although we are a poor community, we place high value on our
children's education. The citizens of Reading make the highest
local tax effort in Berks County and are in the top 15 percent
in the State of Pennsylvania, yet we're able to spend $2,000
less per student than the average. We have a $106 million
general fund budget. If we could spend only the average of the
State's spending per child, we could increase that budget by
over $33 million. In truth, if we could spend what our
neighbors directly to the north of us spend, we could increase
that budget by $70 million.
To me it is unconscionable that in this country the quality
of a child's education is determined by his zip code. For those
who argue otherwise, I would ask you to consider these facts.
Again, as compared to the other 500 school districts in
Pennsylvania, the Reading School District is in the 93rd
percentile for the number of students per teacher, the 92nd for
classrooms with 30 or more children. We're in the 99th
percentile for the number of students who need to share one
computer. We're in the 99th percentile for students per
administrator and the 88th percentile for our professional
turnover rate.
We have many children with many needs, and as our teachers
and our children are working so hard every day to close the
educational gaps, these children have--when they enter our
schools, they're being told by No Child Left Behind that
they're failures.
Members of Congress, we know exactly what needs to be done
to give these children the same opportunities as other children
across the Nation.
Senator Specter. Dr. Jamula, you have 30 seconds.
PREPARED STATEMENT
Dr. Jamula. Yes, thank you. But these initiatives will take
tens of millions of dollars, dollars that we don't have. I urge
Congress to fully fund the mandates of No Child Left Behind. I
urge Congress to reconsider the mandates for the current method
of evaluating and testing special education students. I urge
Congress to reconsider the timelines established for the
evaluation of children who are limited English proficient, and
I urge Congress to consider to hold us accountable by
instituting value-added evaluations for special education and
limited education students.
[The statement follows:]
Prepared Statement of Dr. Melissa Jamula
Members of Congress: Thank you for the opportunity to speak to you
today about No Child Left Behind.
As superintendent of a large urban school district, I strongly
support the tenets upon which No Child Left Behind was created: I
believe that all children can succeed; that public schools should be
held accountable for their success; that we should focus special
attention on children who have traditionally been underserved; and,
that all children deserve to be taught by qualified teachers in a safe
environment. Those beliefs, as stated in No Child Left Behind, without
question, should be the hallmarks that drive our public education
system.
But I also believe that there are specific mandates within No Child
Left Behind that undermine the spirit of the law and truly discriminate
against poor, minority children and the schools that serve them. I
believe that Congress' willingness to address these mandates will be
fundamental to whether No Child Left Behind goes down in history as a
piece of legislation that helped to significantly improve the quality
of education received by all of America's children, or as legislation
that de-railed the public school system.
Today, I would like to provide you with a vivid example of how one
school district is struggling, without success, to comply with No Child
Left Behind.
I am the superintendent of the Reading School District in Reading,
Pennsylvania. Of the 501 school districts in Pennsylvania, we are the
fifth largest, with approximately 16,700 students. We have a diverse
student body: 64 percent of our students are Hispanic; 19 percent are
white; 15 percent are African American; and 2 percent are Asian or
other nationalities. Of our student population, 12 percent of the
children are in a formal English Language Acquisition Program and
another 17 percent are formally identified as special education
students.
About three years ago, the Pennsylvania Department of Education
hired Standard and Poors to analyze annually thousands of pieces of
data, comparing the 501 school districts in the state. This analysis
ranges from academic performance to finances to demographic data. In
order for you to understand my grave concerns about meeting the
mandates of No Child Left Behind, consider these facts about the
Reading School District. Compared to the other 500 school districts in
Pennsylvania, Reading School District ranks in the:
--98th percentile for the percentage of students at or below the
poverty line
--99th percentile for the percentage of children who have English as
their second language
--100th percentile for mobility (Last year, the Reading School
District had 16,280 students. From the time we opened our doors
in September, until May 1, we had over 8,000 children either
move into or from one of our schools!)
--100th percentile for our drop out rate
--1st percentile for adults in the community with at least a high
school diploma
--99th percentile for single parent households
As you can see, indicators suggest we have a needy student
population. Although we are a very poor community, our community places
a high value on our children's education: The citizens of Reading make
the highest local tax effort of the 18 school districts in Berks County
and rank 75th, or in the top 15 percent, in Pennsylvania. Yet, we are
able to spend $2,000 less per student than either our county or the
state average. We have a $106 million general fund budget. If we could
spend the average of what our peers spend, we could increase that
budget by over $33 million! In truth, if we could spend what our
neighboring school district directly to the north spends, we could
increase our budget by $70 million. To me, it is unconscionable that,
in this country, the quality of a child's education is determined by
his zip code. For those who would argue otherwise, I would ask you to
consider these facts. Again, compared to the other 500 school districts
in Pennsylvania, the Reading School District ranks in the:
--93rd percentile for the number of students per teacher
--92nd percentile for classrooms with 30 or more children
--99th percentile for the number of students per computer
--99.8th for students per administrator (meaning, of course that we
have one of the leanest administrative staffs in the state)
--88th percentile for our professional turnover rate (Our starting
teacher salaries are approximately $10,000 below both our
county and state averages.)
In spite of these numbers, I believe we have an excellent school
district. I say that not only as the superintendent, but as a parent
whose child is thriving as a junior at Yale, due largely to the
educational foundation she received in the Reading School District.
But we have many children with many needs. And, as our teachers and
our children are working so hard to close the educational gaps these
children have when they enter school, they are now being told that they
are failures according to No Child Left Behind.
Members of Congress, we know exactly what needs to be done to give
our children the same educational opportunity to succeed as other
children across this nation. Given the resources, we would increase the
length of the school day and the school year, we would institute all
day kindergarten, we would significantly reduce our class size at every
level for all children and would assure that children who have English
as their second language are in classrooms with not more than 15
children, and are taught by teachers and assisted by aides who both are
truly bilingual, so that these children learn English, but not at the
expense of their education. We would provide smaller class sizes, more
intense interventions and year round school for our special education
students. We would use technology as an effective educational tool to
meet the varied needs of our students. And that's just the beginning.
Our schools that have been placed in Year One of School Improvement
under No Child Left Behind have complied with a mandate under this law
and have written school improvement plans. They have written these
initiatives into their plans.
But these initiatives will take tens of millions of dollars; money
we don't have; money that has not been provided through the enactment
of No Child Left Behind. Although our federal funds have grown by about
$6 million since 1999, given our growth in student population, which
consistently is between 300 and 350 students a year for the past 15
years, and, given the profile of the children who are entering our
school district, we actually are able to spend two dollars less per
eligible child using federal funds than in 1999!
I urge Congress to fully fund the mandates of No Child Left Behind,
so that our children, all of our children, are given the educational
opportunities they deserve.
I urge Congress to reconsider the mandates for the current method
of testing special education children and I urge Congress to require
that No Child Left Behind mandates are consistent with the mandates of
IDEA.
I urge Congress to reconsider the timelines established for the
evaluation of children who are limited English proficient and develop
evaluation methods for these children that are consistent with bodies
of research that speak to the number of years it takes for a child,
particularly for a child of poverty, to adequately develop academic
vocabulary.
I urge Congress to continue to hold public schools accountable for
the achievement of both special education children and children who are
limited English proficient by requiring value-added testing, designed
to show the academic growth that each of these children makes each
year.
Members of Congress, while I speak from the point of view of a
superintendent in an urban school district, it is important for you to
know that many of my concerns are shared by superintendents of some of
the wealthiest, most academically successful school districts in
Pennsylvania. Recently, 138 superintendents, from a 14 county region in
Pennsylvania, signed their name to a position paper relative to No
Child Left Behind, which I have included with my testimony.
I thank you for your time today and I urge you to honor the intent
of the No Child Left Behind law by addressing the mandates within this
law that will surely undermine its effectiveness.
Senator Specter. Thank you, Dr. Jamula.
STATEMENT OF DR. JAMES SCANLON, SUPERINTENDENT OF
SCHOOLS, QUAKERTOWN COMMUNITY SCHOOL
DISTRICT
Senator Specter. Dr. Jim Scanlon, superintendent of schools
with the Quakertown Community School District. We'll put your
impressive curriculum vitae in the record.
Dr. Scanlon. Yes, thank you very much. I'm here speaking on
behalf of the superintendents from 138 school districts
representing 14 counties in Pennsylvania, including those
suburban counties around Philadelphia and near our capital of
Harrisburg.
NO CHILD LEFT BEHIND ACT
It's extremely rare that an issue has the power to
galvanize and unite districts so solidly. In fact, I've never
known one issue to arouse so much concern and unity. These
districts are committed to educational excellence, quality
instruction, and accountability for results, all qualities that
No Child Left Behind Act strives to promote.
Each of us supports the concepts of high standards, using
data for decision-making, creating school profiles and giving
information to parents in parent-friendly language, again all
goals of the Act. But there are three major concerns we have
about this law. One, it's inherently unfair to special
education students and conflicts with the Federal law, IDEA,
Individuals With Disabilities Education Act. Two, it disregards
the needs of students who demonstrate limited English
proficiency. And three, it disregards the amount of time,
funding, and resources to meet the requirements in the law.
Children with disabilities have to participate in their
respective State testing programs. They're not designed for
children who have disabilities. Therefore, these tests do not
accurately reflect their academic progress.
NO CHILD LEFT BEHIND ACT AND IDEA
No Child Left Behind and IDEA are two laws that are
polarized. That is, IDEA says special education students are
entitled to progress at different rates. No Child Left Behind
says all students must progress at the same rate. IDEA says
special education data sources tailored to a student's
capabilities must be used to assess his or her progress, while
No Child Left Behind says standardized test data must be used
to assess progress. IDEA measures student progress against
standards based on current levels of performance. No Child Left
Behind measures progress against universal grade-level
standards.
Basically, No Child Left Behind has no consideration for
the special learning needs of special education students. We're
being asked to answer to two completely contradictory Federal
laws and our special needs students are caught in the middle.
LIMITED ENGLISH SPEAKING STUDENTS
No Child Left Behind requires non-English-speaking students
to be assessed during their first year of attendance in school
in the United States. In effect, these limited-English-speaking
students are being forced to take a test many of them don't
even understand. Research shows it takes 5 to 7 years for
students to learn the language proficiently.
COSTS OF NO CHILD LEFT BEHING ACT
Many of our school district budgets receive between 1 and 2
percent of Federal money. Most of it comes in the form of title
I funds, which is targeted for early childhood reading and
math. No Child Left Behind forces us to spread the title I
funds across our entire district, and although title I funds
have increased, they have not increased in proportion to the
number of children those funds are now supposed to cover. It's
like giving someone a queen-sized comforter instead of a sofa
throw but now asking them to keep 10 people warm with it
instead of two. Someone's going to be left out in the cold.
Districts will also have to incur other costs because of No
Child Left Behind. They include hiring and training
professionals to meet highly qualified provisions,
transportation costs for families exercising school choice
options, additional infrastructure and staff for analyzing test
scores, the cost of additional teachers and aides to provide
remediation. The list goes on and on.
FLEXIBILITY FOR IDEA AND LEP STUDENTS
We're asking you to do the following to help us better
educate and change what we firmly believe is destructive rather
than constructive legislation. One, allow special education
students' progress to be measured by the assessments in their
individual education plans protected under the Federal law,
IDEA. Essentially, allow IDEA to drive the evaluation of
special education students.
Two, provide sufficient time and accommodations for
assessing limited-English-speaking students, and I know
Secretary Paige has addressed some of that recently. However,
we believe one year is not quite enough. Give them more time to
learn the language before they're tested.
PREPARED STATEMENT
Fully fund No Child Left Behind to support schools and
districts. Study, analyze, collect data, and learn how much
this law and its changes will really cost us, and then
adequately fund it so that we can fulfill the requirements.
We'll continue to work to provide the best learning
environments possible for our students and staff. It's our duty
to point out the flaws in this law, and I hope you will work
with us, not against us, toward the common goal of educating
our children. Thank you for listening and learning with us.
[The statement follows:]
Prepared Statement of Dr. James R. Scanlon
I am here speaking on behalf of the superintendents from 138 school
districts, representing 14 counties in Pennsylvania, including those in
suburban Philadelphia and near our capital of Harrisburg.
It is extremely rare that an issue has the power to galvanize and
unite districts so solidly--in fact, I've never known one issue to
arouse so much concern and unity.
These districts are committed to educational excellence, quality
instruction and accountability for results, all qualities that the No
Child Left Behind Act strives to promote. Each of us supports the
concepts of high standards, using data for decision-making, creating
school profiles and giving information to parents in parent-friendly
language--again, all goals of the Act. BUT--there are three major
concerns we have about this law:
1. It's inherently unfair to special education students and
conflicts with the federal law, IDEA (Individuals with Disabilities in
Education Act).
2. It disregards the needs of students who demonstrate limited
English proficiency.
3. It disregards the amount of time, funding and resources to meet
the requirements in the law.
Children with disabilities have to participate in their respective
state testing programs--that are NOT designed for children who have
disabilities--therefore these tests do not accurately reflect their
academic progress.
No Child Left Behind and IDEA are two laws that are polarized--that
is, IDEA says special education students are entitled to progress at
different rates. No Child Left Behind says all students must progress
at the same rate. IDEA says specialized data sources tailored to a
student's capabilities must be used to assess his or her progress. No
Child Left Behind says standardized data sources must be used to assess
progress. IDEA measures student progress against standards based on
current levels of performance. No Child Left Behind measures progress
against universal grade level standards. Basically, No Child Left
Behind has no consideration for the special learning needs of special
education students. We are being asked to answer to two completely
contradictory federal laws, and our special needs students are caught
in the middle.
No Child Left Behind requires non-English speaking students to be
assessed during their first year of attendance in school in the United
States. In effect, these limited English speaking students are being
forced to take a test many of them don't even understand. Research
shows it takes five to seven years for students to learn the language
proficiently.
Many of our school district budgets receive between one and two
percent in federal money--most of it comes in the form of Title One
funds, which is targeted for early childhood reading and math. No Child
Left Behind forces us to spread the Title One funds across our entire
district--and although Title One funds have increased, they have not
increased in proportion to the increase in the number of children those
funds are now supposed to cover. It's like giving someone a queen-size
comforter instead of a sofa throw but now asking them to keep 10 people
warm with it instead of two. Someone's going to be left out in the
cold.
Districts will also have to incur other costs because of No Child
Left Behind. They include: hiring and training paraprofessionals to
meet ``highly qualified'' provisions; transportation costs for families
exercising school choice options; additional infrastructure and staff
for analyzing test scores; the cost of additional teachers and aides to
provide remediation. The list goes on and on.
We are asking you to do the following to help us better educate our
children and change what we FIRMLY believe is destructive, rather than
constructive legislation:
1. Allow special education students' progress to be measured by the
assessments in their individualized education plans, protected under
the federal law, IDEA. Essentially, allow IDEA to drive the evaluation
of special education students.
2. Provide sufficient time and accommodations for assessing limited
English speaking students--essentially, give them more time to learn
the language before they are tested.
3. Fully fund No Child Left Behind to support schools and
districts--study, analyze, collect data, and learn how much this law
and its changes will really cost us--and then adequately fund it--so
that we can fulfill the requirements.
We will continue to work to provide the best learning environments
possible for our students and staff. It is our duty to point out the
flaws in this law, and hope you will work with us, not against us,
toward the common goal of educating our children.
Thank you for listening, and learning with us!
Senator Specter. Thank you very much, Dr. Scanlon. As I
said earlier, Secretary Paige has to leave at this point, but
he's very graciously agreed to meet with all of you at 2 p.m.
this afternoon in his office. I want to announce that there are
others who have come from Pennsylvania--Dr. Jacob Dailey, who's
the director of legal and external relations at the Chester
County Intermediate Unit; Dr. Mary Lou Folts from the
Tredyffrin/Easttown School District; Dr. Melody Wilt from the
Chester County Intermediate Unit; and Dr. Mark Dietz from the
Wyomissing Area School District. And those folks may be
included as well, Secretary Paige.
I'll have one of my staffers take you over. Secretary Paige
has to leave at this point, and we're going to interrupt the
hearing for just a few minutes and we'll resume with the
balance of the witnesses in just a few minutes.
Secretary Paige. Can we say thank you very much for your
leadership and the opportunity to come and testify before you.
Senator Specter. You're very welcome, Mr. Secretary. The
issues here are very important and I appreciate your open ear.
It's good to have the Secretary's ear and even better to have
the Secretary's pen, but you start with his ear. And what we're
always doing around here, and you saw a number of Senators
wanted to ask more questions, but we have so much time and so
many commitments. But you have provided the very good safety
valve, Mr. Secretary, by being willing to meet this afternoon,
and for the record here, we'll continue to hear from the
witnesses after a very brief recess.
I regret the interruption, but I had to address a veterans
convention in Harrisburg. There's a great problem when somebody
is selected to the Senate and he or she is not twins or
triplets.
STATEMENT OF DR. MARIE SLOBOJAN, DIRECTOR OF
INSTRUCTION, TREDYFFRIN/EASTTOWN SCHOOL
DISTRICT
Senator Specter. I return now to Dr. Marie Slobojan,
director of instruction, staff development, and planning at the
Tredyffrin/Easttown School District. I'm sorry that you don't
have the Secretary here, but you have--would you identify
yourself for the record?
Mr. Simon. Yes, I'm Ray Simon. I'm Assistant Secretary for
Elementary and Secondary Education.
Senator Specter. And this gentleman is right in line with
the issues, but you'll have the Secretary's ear, as I said
earlier, at 2 p.m. Dr. Slobojan, thank you for joining us and
we look forward to your testimony.
Dr. Slobojan. Thank you for inviting us to discuss the
impact of the reauthorization of the Elementary and Secondary
Act in the Tredyffrin/Easttown School District. As you can see
from the district profile that we submitted, Tredyffrin/
Easttown School District is a high-performing K-12 district as
determined by multiple measures of performance, including
scholastic aptitude tests, educational record tests, and
advanced placement standardized tests.
We consider the SAT a particularly informative measure of
our performance, because typically 100 percent of our students
participate in this test. Our average daily attendance is 96.6
percent and we graduate 99.9 percent of our students. We take
our responsibility to educate every child very seriously by
setting and enforcing strong standards of accountability for
our district.
The Pennsylvania School System of Assessment is the single
academic measure of performance that defines the district's
adequate yearly progress. Students must perform at the
proficient or above-proficient level.
TREDYFFRIN/EASTTOWN SCHOOL DISTRICT
The 2002-03 Standard & Poor's report for our district
states the following: Statewide, none of Pennsylvania's school
districts report a greater proportion of test scores that meet
or exceed State standards. Statewide, none of Pennsylvania's
school districts report higher proportions of scores in the
advanced performance level. Across the State, none of
Pennsylvania's districts report a smaller proportion of scores
in the below-basic performance level.
In spite of such an extraordinary record of meeting the
needs of children, strongly supported by our community, the
current version of the Elementary and Secondary Education Act
has endangered the public school students in our district.
Point one, all students in our school district are
currently experiencing a skewed educational program designed to
ensure their success on the Pennsylvania assessments in
mathematics and reading. Placing this emphasis on a single
high-stakes test detracts from the rich curriculum and creative
environment that promotes self-directed, lifelong learning that
students in our district have come to expect.
Teachers within the district feel constrained by the narrow
parameters suggested in the State curriculum. We believe that
our compliance with this initiative results in our providing a
regressive educational experience for our students.
Second, our district receives no title I funds. Therefore,
any compliance action we take is funded from our local
resources. This means that we redirect our funds from existing
programs with demonstrated success.
Point three, in the 2002-03 school year, we were audited in
our special education program and identified as having
exemplary practices for the State of Pennsylvania. This year,
we anticipate that we will placed on the warning list for this
special education subgroup. We believe that this will start our
6-year march to privatization in the Tredyffrin/Easttown School
District.
NCLB ACT AND THE INDIVIDUALS WITH DISABILITIES ACT
We believe the principles of the No Child Left Behind
legislation violate the instructionally sound framework of the
Individuals with Disabilities Act. Principle one, children
learn at different rates. Principle two, valid student
assessment involves multiple data sets. Principle three,
effective instruction and assessment is delivered at the
student's instructional level. The result is that these
students are experiencing stress, fear, and they risk being
ostracized due to their inclusion in a federally labeled
subgroup.
NCLB ACT AND LIMITED ENGLISH PROFICIENT STUDENTS
Point four, we currently have 111 English language learners
speaking 29 different languages. The Federal requirements for
testing are inconsistent with the research, which suggests it
takes approximately 7 years for non-native speakers of English
to acquire proficiency to perform on standardized tests.
During the testing period, students demonstrate anger and
frustration. Students who are about to take this test feel as
though they are forced to show that they will fail. The sense
of failure has made it difficult to encourage students to learn
English and to improve their proficiency. In effect, the law is
having the exact opposite effect it was designed to promote.
Senator Specter. Thirty seconds left.
PREPARED STATEMENT
Dr. Slobojan. I'll just skip to my concluding remarks. In
order to effectively assess the progress of our students for
the purposes of adequate yearly progress, please include
multiple assessments, factor subgroups into an equation that
weights their proportion within the school population as a
whole, develop appropriate assessments and have comparable
tests and standards across all States.
We ask you to amend the legislation to fairly assess the
multiple dimensions of human intelligence and to respect the
dignity of every student.
[The statement follows:]
Prepared Statement of Dr. Marie Slobojan
Honorable Senators: Thank you for inviting us to discuss the impact
of the reauthorization of the Elementary and Secondary Education Act in
Tredyffrin/Easttown School District.
As you can see from the District profile, Tredyffrin/Easttown is a
high-performing K-12 school district, as determined by multiple
measures of performance including Scholastic Achievement Tests,
Educational Records Bureau tests and Advanced Placement standardized
tests. We consider the SAT a particularly informative measure of our
performance because typically 100 percent of our students participate
in this test. Our average daily attendance is 96.6 percent and we
graduate 99.9 percent of our students. We take our responsibility to
educate every child very seriously by setting and enforcing strong
standards of accountability for our district.
The Pennsylvania School System of Assessment, or PSSA, is the
single academic performance measure that defines the district's
Adequate Yearly Progress where students must perform at the proficient
or above proficient level. The 2002-03 Standard & Poor's report for our
District states the following:
--Statewide, none of Pennsylvania's school districts report a greater
proportion of test scores that meet or exceed state standards.
--Statewide, none of Pennsylvania's school districts report higher
proportions of scores in the Advance performance level.
--Across the state, none of Pennsylvania's districts report a smaller
proportion of scores in the Below Basic performance level than
this district.
In spite of such an extraordinary record, of meeting the needs of
every child, strongly supported by our community, the current version
of the Elementary and Secondary Education Act has endangered the public
school students in our district.
POINT 1
All students in our school district are currently experiencing a
skewed educational program designed to ensure their success on the
Pennsylvania assessments in mathematics and reading. Placing this
emphasis on a single high-stakes test detracts from the rich curriculum
and creative environment that promotes the self-directed life-long
learning that students in our district have come to expect. Teachers
within our district feel constrained by the narrow parameters suggested
in the state curriculum. We believe that our compliance with this
initiative results in our providing a regressive educational program
for our students.
POINT 2
Our District receives no Title I funds. Therefore, any compliance
action we take is funded from local resources. This means that we
redirect funds from existing programs with demonstrated success to
programs that provide remediation for state testing.
POINT 3
The 2002-03 school year audit of our Special Education Program
identified our District as having exemplary practices. In 2003-04, we
anticipate that we will be placed on the warning list for this special
education sub-group, thus starting the six-year march to privatization
for the Tredyffrin/Easttown School District.
We believe the principles embodied in the No Child Left Behind
legislation violate the instructionally sound framework of the
Individuals with Disabilities Act.
Principle 1.--Children learn at different rates.
Principle 2.--Valid student assessment involves multiple data sets.
Principle 3.--Effective instruction and assessment is delivered at
the student's instructional level.
The result is that these children are experiencing stress and fear
and risk being ostracized due to their inclusion in a federally labeled
sub-group.
POINT 4
Currently we have 111 students in our English Language Learners
program, speaking 29 different languages. The federal law requires that
these students be tested in English following three years of tutoring
in English. Research indicates that it takes a minimum of 7 years for a
nonnative speaker of English to gain the proficiency level that
translates into successful performance on most standardized tests.
During the test, students taking the assessment have demonstrated
anger and frustration. Going through a test where only the directions
were translated made the students feel as though they were forced to
demonstrate what they did not know. Currently students who are about to
take this test feel that they are forced to participate in an
assessment they will fail. This sense of failure has made it difficult
to encourage students to learn English and to improve their
proficiency. In practice, this law is having the exact opposite effect
it was designed to promote.
POINT 5
Pennsylvania's calculation of Adequate Yearly Progress places
students in our Commonwealth at a disadvantage to students in other
states. This disadvantage occurs because the proficiency in standards
across the United States punish students in states where the standards
are high. For school districts such as ours, that already meet the
state's annual requirements, this concept is regressive. While other
school districts have until the year 2014 to meet these goals, the high
achievement of our district's students places us on the warning list if
we marginally drop from the high standards that we currently achieve.
In order to effectively assess the progress of our students for the
purposes of Adequate Yearly Progress we recommend the following
changes.
1. Include multiple assessments of academic performance in the
Adequate Yearly Progress formula.
2. Factor sub-groups into an equation that weights their proportion
within the school population as a whole. In this way sub-groups would
not carry the same weight as the entire school population.
3. Develop assessments that are appropriate for students with
special needs and those who are English Language Learners. Use those
assessments in the Adequate Yearly Progress calculation.
4. Have comparable tests and standards across all states for the
calculation of Adequate Yearly Progress.
The Tredyffrin/Easttown community is proud of the public education
that it provides for its students. We have always accepted
responsibility and demonstrated accountability for the performance
results of every student that we serve. We respectfully request
amendments to the legislation to fairly assess the multiple dimensions
of human intelligence and to respect the dignity of every student that
is educated in public school districts across this nation. Thank you
for your attention.
Senator Specter. Dr. Slobojan, we have your point and we
thank you very much. Moving right down the table in sequence,
sitting next to Dr. Slobojan is Mr. Samuel Evans. Mr. Evans is
the founder of the American Foundation for Negro Affairs, a
long list of accomplishments, being appointed by President
Roosevelt. Was that Franklin or Theodore, Mr. Evans?
Appointed by President Roosevelt, I know it was FDR, as the
coordinator of the U.S. Division of Physical Fitness. President
Johnson appointed him as czar of the war on poverty. He's the
founder of Youth City, the cooperative education extension
service and the family of leaders.
Mr. Evans celebrated his 101st birthday last November. Sam
Evans was older than Strom by a full month. Sam Evans is about
the only man in America who could--who did refer to Strom
Thurmond as one of the young guys.
STATEMENT OF SAMUEL LONDON EVANS, FOUNDER, AMERICAN
FOUNDATION FOR NEGRO AFFAIRS
Senator Specter. Mr. Evans, we're honored to have you here,
and you have wanted to meet with Superintendent Paige for some
time. We're going to put your testimony in the record and this
afternoon you're going to have a chance to meet with Secretary
Paige. It's an honor to have you here, Mr. Evans.
Mr. Evans. Thank you, Mr. Chairman. Let me say right away
that I was up this morning around 3:30, 4:00 to be sure I get
here because when Senator Specter calls me, I have to go. Let
me say right away that I asked President Carter, when he was
running for office, to set up the Department of Education.
Everywhere I go I hear people talking about education. Nations
of the world are rated on three things: what percent of that
nation is educated; number two, what percent is economic
secure; and number three, what is their behavior pattern and
sense of values?
It is right here our behavior pattern and sense of values
in education that is destroying America's democracy. America
ranked 22 among the nations in science, mathematics, and
education. It means then that the United States--21 nations in
the world are greater educated than we are. It's because our
behavior pattern and sense of values about education is
contaminated with colonial concepts.
Every step of the way it is preventive rather than
encouraging. Let's take one instance. When you put a power in
the hand of an individual today, the success of a student on
any level is no further than the pen or pencil of his professor
teacher. He has that power. But that awesome power is the
control numbers. If you take up the philosophy of education,
take it up and study it, you'd be amazed at the--how many
individuals understand the American--you see, for instance,
goal from K to graduate school, you come out, they will believe
in six things, six, and those six will aid the controlling
power and harm the other group.
Number one, they believe in war, w-a-r, war. You keep the
guns. Now you got population to deal with, we got to cut them
up, cut them up into pieces, so therefore, number two, you
believe in getting ahead of others rather than getting rid of
the others. And number three, you believe in class distinction.
Senator Specter. Mr. Evans, you have 1 minute left.
PREPARED STATEMENT
Mr. Evans. Number four, you believe in authority. I'm sorry
that I come here today, but I'd be glad to talk to anyone. I
want to end by saying this, that the American educational
system must be purified. Thank you.
[The statement follows:]
Prepared Statement of Samuel London Evans
The Frontiers Of Knowledge In: Integrated Concepts Of Science,
Philosophy And Education Is Eliminated From The Established Schools Of
Learning That Propagates Specialization. Therefore, The Curriculum Is
Limited To Only ``One'' Of The Following Subjects:
1. Philosophy Of Education
2. Basic Concepts And Modern Physic
3. Theory Of Values
4. Nature Of Mathematics
5. Anthropology
6. Astronomy
7. Paleontology
8. Stars And Nebulae
9. The World Of Crystal
10. Direct Implicit In The Structure Of Earth
11. Gestalt Psychology
12. The Nature Of Aesthetics
13. Signs Symbols And Personalities
14. Laws Of Density
15. The Nature Of Meteorology
16. The Nature Of Etiquette
In This Connection, Students Who Are Limited To: ``Only One,'' Of
The Above Subjects, Are Recognized As ``Educated Models,'' However, The
AFNA Program Serves In Two Or More Capacities:
ONE.--``The AFNA Plan,'' Prepares The Student To Meet The Academic
Requirements Of The School He Or She Attends, In Order That They May
Pursue Professional Careers In: Medicine, Law, Computer Science,
Business And Commerce, To The Humanities.
TWO.--Beyond This, ``AFNA Students'' Are Privileged To Learn And
Study The Entire Basic Structure Of: The Frontiers Of Knowledge, In
Integrated Concepts Of: Science, Philosophy And Education.
THREE.--Professors And Educators, Will Lecture In: One Of The Above
Subjects . . . In This Connection, The Students Will Receive A Copy Of
Each Lecture And Required To Take It Home For Study And Review . . .
Students Then, Are Required To: Rewrite The Lecture, With The
Cooperation Of Their Parents And Qualified Neighbors, All Assisting The
Student . . . ``He'' Or ``She'' Will Then Bring A Copy Back To Their
Class For Evaluation . . .
Students Will Receive:
--Ten Points For Completion
--Ten Points For Spelling
--Ten Points For Neatness
--Ten Points For Format
--Ten Points For Clarity And Etc.
Means, The Total Experience Will Bring Academic Surroundings Back
Into The Home And Made Available To Family And Community, For Study And
Review . . . With The Desire To Expand The Concept Of Academic
Scholarly Learning in The Home And Community Level.
FOUR.--In This Connection, Students Are Required To Keep Copies Of
Each Lecture For Their Files . . . For It Is Hoped That Each Student
Will Complete Written Studies Of: ``The Sixteen Subjects, From 7th
Grade, Through High, College And Graduate School . . .'' Indeed, Such
An Achievement; Would Place Students On That High Rarefied Academic
Platform, That Holds Less Than 7 percent of The World's Scholars.
FIVE.--AFNA Is Not A School, College Or University. AFNA, Is A
Supplementary Schooling Institute . . . Working And Preparing Students
To Meet Their Academic Qualifications, In Cooperation With Academic
Schools Of Learning. Together, AFNA, Universities, And Colleges, Work
To Obtain The Needed Funds From: Federal, State, City And
Philanthropists; To Eliminate The Dismissal Of Students For Tuition
Deficiencies.
The Need To Eliminate, ``BAR AND BOARD'S FAILURES,'' Based On
Academic Deficiencies, Of Which The Students Have Already Obtained And
Qualified Through Their Graduate Schools Of Learning.
SIX.--Beyond This, AFNA; Requires That Each Student Be Given A Copy
Of: ``The Declaration Of Independence,'' For Each To Study, Learn, And
Recite . . . For It Represents The Basic Roots And Meaning Of: ``The
American Form Of Government'' . . . Which Has Been Largely Eliminated
In Schools Of Learning.
Today, At This Writing 2004; 5th Of January, Humanity Is Divided
Into A Multitude Warring Camps . . . With Each Group Fighting For Their
Individual Advancement, Based On The Concept Of The Fastest Draw.
Yet, Humanity Is 99.9 percent The Same, The 1 percent Difference Is
Environment, Culture And Ethnicity . . . However, ``The AFNA Plan,'' Is
Based On The Concept:
``One God And One Humanity'' . . .
``Seek Not Advantage Over Others, Seek Equality And Justice For
All''
``Therefore, Democracy Is The Key, That Provides For Individuals,
Or Groups, To Work Out Their Own Way Of Life, Without Fear, Or Without
Hindrances And Without Destructive Attitudes Towards Others.''
Therefore, No Race, Political Ideology, Religion, Commercial
Enterprise Are Worth Saving, If It Destroys The Democratic Process Of
Government.
``The AFNA Model,'' Students Learning In Cooperation With Parents,
Guardians, Relatives, And Friends, Will Join The Other AFNA Graduates .
. .
--750 Medical Doctors
--550 Lawyers
--96 PhD's
--4,500 College Graduates
And Many Other Para-Professionals In The Health Fields.
Evaluation
[Mithras Group Ltd., Aaron N. Katcher, M.D., Chairman And Director, Of
The Division Of Behavioral Sciences, University Of Pennsylvania]
Indeed, In Evaluating The AFNA Plan: We List Below The Following
From: The Mithras Group Ltd., Aaron N. Katcher, M.D., Chairman And
Director, Of The Division Of Behavioral Sciences, University Of
Pennsylvania.
excerpts of the evaluation (mgl) process
In This Connection, We Know; Doubt Comes From The Thought That You
Could Be Doing Better. Well-intended, Even Satisfying Effort Is Not
Always Effective . . . Are The Courses In AFNA The Right Ones, Should
The AFNA Students Be Spending Their Time In A Laboratory, And Are They
The Right Students For The Program?
The Above And The Following Doubts, Are Doubts About ``The Model''
. . . ``The Plan'' . . . Is It The Best Mode For A Supplementary
Minority Education Program? In Describing, ``The Model,'' We Also
Described How We Displayed That Mode To A Succession Of Audiences In
Pursuit Of Critical Commentary . . . The Meetings Of The American
Association Of Medical Colleges, The Conferences Of Educators With
Interest In Minority Problems, Convened In Philadelphia And New
Orleans. The Discussions, With Faculties Of The Participating Medical
Colleges, And The Paper Presented To The Association For Higher
Education In Chicago.
One.--In All Of These Meetings, ``The Model''; Was Exposed For
Evaluation, Amendment And Revision. No Substantive Suggestion For
Change Were Offered. If There Were Anything Better Or More: The
Participants In The Program Should Be Doing, Those Who Should Know,
Were Silent About Describing What That ``More'' Might Be . . .
Two.--The Next Doubt, Was A Question About The Outcome Of The
Program . . . That Goes Beyond The Know/edge Of Personall Success Of
The Students We Have Known In The Program; The Kind Of Description Of
Outcome That Goes Beyond Individuals, To The Abstraction Of Numbers.
The Numbers And Findings Have Been Gathered:
(A) 98 percent Of Those Completing The High School Phase Of The
Program Go On To College . . .
(B) College Retention Rate Over All Four Years is 83 percent . . .
(C) 57 percent Of The Students Entering College, Graduate . . .
AND THE IMPORTANT BOTTOM LINE,
(D) 25 percent Of The Students Who Enter College, Go On To
Graduate, Or To Medical School . . .
An Evaluation Of The Program Conducted In Cooperation With The
Educational Testing Service Of Princeton, Demonstrated, The Program's
High Retention And Graduation Rates From High School . . . This Record
Was Achieved With Students, Whose SAT Scores Were Well Below The
Average Goals For Students In College They Attended.
Therefore, The Evaluation Of ``The Model'' Presented Herein Has Met
Every Test And Goes Over And Beyond The Usual And Previous Analytical
Problems Of Leaders. Indeed, ``The Model'' Has Accomplished Its
Purposes.
So In Conclusion, When The AFNA Students Have Reached The
Requirement Of Their Profession, They Will First Direct Their Knowledge
In:
``Building Security Of: The Family, Mother, Father, Guardian, And
Country . . . The Very Roots Of Your Living And Being, To Meet Their
Needs In The Sunset Of Their Life.''
Indeed, Brothers And Sisters, Under This United Conviction, We:
``WOULD RATHER RIDE IN AN OX-CART, OR A COVERED WAGON IN A
DEMOCRACY . . . THAN IN A ROLLS ROYCE, DRIVEN UNDER A DICTATOR.''
Senator Specter. Thank you very much, Mr. Evans. Thank you
for your profound statement.
STATEMENT OF C. DELORES TUCKER, FOUNDER, PHILADELPHIA
MARTIN LUTHER KING, JR. ASSOCIATION FOR
NON-VIOLENT CHANGE
Senator Specter. We turn now to Dr. C. Delores Tucker,
founder and national chair of the National Congress of Black
Women, also founder and president of the Bethune-DuBois
Institute and the Philadelphia Martin Luther--Dr. Martin Luther
King, Jr. Association for Non-Violent Change. She served as
Pennsylvania's Secretary of State, attended Temple University
and the Wharton School of the University of Pennsylvania. Thank
you for joining us, Dr. Tucker, and I might add to your regular
resume your leadership on education at Cheyney and other
educational institutions.
Dr. Tucker. Thank you so much. I can't say much about you
because of the 5-minute rule, but nevertheless, to leave a
child behind is to leave a child behind forever. We as a Nation
can ill afford to allow ourselves to slip into a second-rate
position in any area of global competition. The No Child Left
Behind Act must be more than a slogan. It must be a reality.
Outsourcing is one of the problems that we're facing
because we have not met up to that position of that child being
educated. I'm going to say all of this to get to my time. There
is a wealth of undeveloped talent languishing in the urban
centers of America, but we have the will and the vision to
really tap into what this Nation needs, a tap into the brain
pool of wealth. America would be assured of achieving
educational superiority over all nations in this century.
COLLEGE FOR TEENS PROGRAM
The National Congress of Black Women, the Philadelphia
Martin Luther King Association, of which you serve on our board
with our mayor, Senator Specter, we have tapped into this brain
pool of wealth with our College for Teens program, which grew
out of our College for Kids program, 9 to 12 years of age,
which began at the University of Pennsylvania 10 years ago, and
parents said you can't drop them at 12 years of age, that's
from 9 to 12. And so I said, what can we do? College for Teens.
We approached you, and you recognized the need for training our
young people early.
Thirteen months after I met with the president of Cheyney
University, we cut the ribbon for 200 students to live on
Cheyney's campus in the summer learning the work that they're
going to have in the fall and being taught by the Princeton
Review national organization, training them to learn the work
that they're going to have in the fall, but also geared toward
enhancing their SAT scores.
STUDENT PARTICIPANT OF COLLEGE FOR TEENS PROGRAM
I have one of the young persons here now that was a part of
the second College for Teens program. We had 246 young people
living on campus at Cheyney University this past fall--summer
rather. And she's here today, and I want you to stand right
here for a minute, quickly please, and tell him what your
scores increased to when you went into the school and when you
came out of the school.
Ms. Dursey. When I started I had----
Senator Specter. Would you step forward and speak into the
microphone? First, if you would identify yourself, please.
Dr. Tucker. You have 5 minutes too, right? Yeah, 2\1/2\,
2\1/2\. I'll let the child speak.
Ms. Dursey. Hi, my name is Nakeisha Dursey. I'm a
Philadelphia student at the Philadelphia High School for Girls.
When I first started the program my score was 1,140. When I
left it was 1,400.
Dr. Tucker. It was 1,100?
Ms. Dursey. It was 1,140 when I started.
Dr. Tucker. And then when you left?
Ms. Dursey. It was 1,400.
Dr. Tucker. 1,400. That's what we do. Her parents are here,
her mother is here, and we have others that have come, but we
just wanted to have a child speak with you today. The first
year the Princeton Review provided SAT preparation classes for
all program participants whose student achievement--well, I
skipped so many pages I'm up to page 6--but the Martin Luther
King Association for teens exemplifies your program, Senator
Specter, your zeal for student achievement. One hundred percent
of all graduating high school seniors from the 202--the 2002
MLK program successfully completed the college application
process and were accepted into college. And this last class,
the 246th, we didn't have the money for it but we reached out
to do it anyhow.
I'm saying as I close, I got so far down here I'm at the
end--with the outsourcing of jobs overseas, education is no
longer a domestic issue. It is now a global issue. No Child
Left Behind must become the catalyst for success for all of
America's students. The law meant to deliver on President
Bush's campaign promise to improve public school education with
specific regard to the substandard educational opportunities
that have been historically offered to poor and minority
students.
AFTER SCHOOL AND SATURDAY PROGRAMS
Clearly, Senator Specter, you have maximized the funding
opportunities that we needed because this isn't just the summer
program. We have an after-school program coupled with this
where we make sure they stay ahead and they keep ahead of the
courses and they have--they're great students when they go into
school and they just say that we're bored now, we don't have
everything, everybody wants to tell us--want us to tell them
how to do things.
Well, we also have a Saturday program where they come in
and enhance their computer skills and we give them a free
computer, so we help them in every way, and we just want you to
know that this year we hope to have 300 students on that campus
and we've started another College for Teens at Capital College,
which is right here in Maryland, and the Justice Department has
said this is one of the model programs that they have seen in
this country. Nowhere else is this program done, but it's a
vision that I had because I've been raising and working for
children all my life.
CHILDREN WITHOUT HOMES
When I was Secretary of State, I went up to school to get
the kids registered. I got the voting age reduced from 21 to
18. I saw the gang coming into the high school. I said why do
you travel with gangs? And you know what they said to me? And
this is what I want to leave with you. They said, Dr. Tucker,
you have to understand, the gang is our family and the street
is our home. We wanted Gerard College, because where these
children don't have homes, and too many don't, that's where the
problem is, that's where the problem is. Those who do not have
parents, like the little 6-year-old boy that was living with
his mother, she was on drugs, father in jail, mother on drugs,
Flint, Michigan, and they took him, put that boy into a home
with his relative and that was a crack house. So he went to
school one day in Flint, Michigan and killed a student who was
6 years old.
prepared statement
So we need to deal with the children who do not have homes,
like Gerard College, and I would like to invite the Senate for
you to bring a team up there. That's what Steven Gerard did in
the 1800s. He was an orphan, and he said, in order to take
these children and train them and make them the best that they
are--and when I gave the graduation address there the other
day, I cried, because I've never seen so many males walking in
a graduation class, because 15 to 24, 60 percent of that age
are in what I call the three-P: prison, parole, probation.
The last point that you always hear, this is a cost. It is
not a cost. It is an investment. It's an investment that will
take care of itself, and either we are going to educate or the
other choice is incarcerate, and that's the cost.
[The statement follows:]
Prepared Statement of Dr. C. Delores Tucker
To leave a child behind now is to leave a child behind forever! We,
as a nation, can ill-afford to allow ourselves to slip into a second
rate position in any area of global competition. The No Child Left
Behind Act must be more than a slogan; it must be a REALITY, if America
is to maintain her position of influence and respect in the global
community. The greatest power that America can amass at this juncture
in history is BRAIN POWER!!! Even as we deliberate here today, many of
our blue chip companies are OUTSOURCING jobs that require critical
thinking and analytical skills as well as high-tech jobs because it is
said that not enough students who graduate from our high schools,
colleges, and universities have the academic prowess to perform
efficiently and competitively. This is a sad commentary on the most
powerful country in the world!
Every day and every week we are reading reports where America is
losing its advantage because of a perceived lack of Brain Power on the
part of our youth. Conversely, an excellent commentary on the world's
leading nation is that congressional appropriations support public
schools as well as comprehensive youth development programs that
prepare students to succeed in any aspect of the American workforce,
that is, congressional appropriations reinforce America's greatness!
I am here today to applaud and praise the Congress for the progress
you have made in recognizing how important youth development programs
are in maintaining educational excellence in our great nation. There is
a wealth of under developed talent languishing in the urban centers of
America. If we have the will and vision to really tap into this ``Brain
Pool of Wealth'', America would be assured of achieving educational
superiority over all nations, in this century.
The National Congress of Black Women and The Philadelphia Martin
Luther King, Jr. Association for Nonviolence have begun, what we
believe to be, a very unique program, in Philadelphia, Pennsylvania, to
tap into this Brain Pool of Wealth. It is our College For Teens
Program, which began in 2001 at Cheyney University, in Pennsylvania. It
allowed low-income, first generation, minority students to experience
the rigors of a college environment for six weeks. It features a three
(3) pronged approach to student achievement:
1. An After-School Tutorial Program that focuses on direct
instruction in language arts and mathematics;
2. Saturday Computer classes that bridge the digital divide; and
3. Summer College Residency Program that features a six to eight
week college preparation program, where students live on the college
campus and prepare for the SAT, receiving academic preparation from The
Princeton Review professionals.
Longitudinal data reveal that The SUCCESSES of those students are
phenomenal!
The first year The Princeton Review provided SAT preparation
classes for all program participants, whose grades represented eighth
through twelfth. THE AVERAGE GAIN IN PRE and POST SAT RESULTS WERE 140
points, as measured by The Princeton Review. This success was a direct
result of the investment Senator Arlen Specter made in the public
school children of Philadelphia.
In 2002, TWO HUNDRED STUDENTS participated in the Philadelphia
Martin Luther King, Jr. Association for Nonviolence's College For Teens
Program because Senator Specter is committed to early intervention for
student success and he wants to close the achievement gap that
presently exists between urban and non-urban student populations.
Senator Specter is to be commended for raising the level of
expectations for all of America's students so that America will bridge
the digital divide and the student achievement gap. He has done this by
thoroughly examining the tenets of all appropriation requests, ensuring
that America's dollars will yield American success.
The MLK Association's College For Teens Program exemplifies Senator
Specter's zeal for student achievement.
Examples:
--100 percent of all graduating high school seniors from the 2002 MLK
program successfully completed the college application process
and were accepted into college;
--School attendance in the targeted middle and high schools
increased;
--Parent participation in school activities increased; and
--SAT scores measured average gains of 160 points.
Examples:
--In 2003--246 students were enrolled in the College For Teens
Program representing grades seven through twelve;
--80 percent of the student population represented returning
students; and
--SAT Scores soared an average of 200 points!
One high school sophomore, who is with me today, increased her 2003
SAT Score by almost 400 points!
Her mother and grandmother comprise 50 percent of the executive
committee of her high school PTA, and she has maintained a 3. GPA
throughout high school, and until today has a nearly perfect attendance
record for the first two years of her high school career.
With the OUT-Sourcing of jobs overseas, education is no longer a
domestic issue . . . it is now a global issue! No Child Left Behind
must become the catalyst for success for all of America's students! The
law was meant to deliver on President Bush's campaign promise to
improve public school education, with specific regard to the
substandard educational opportunities that have been historically
offered to poor and minority children. Clearly, Senator Arlen Specter
has maximized his funding resources to advance public education and
community development in limited communities in Philadelphia.
In closing, Senators, I say to you, think for a moment what it
would mean to America's future to have one million inner-city children
involved in a program like this one. We must remember that education is
not a cost but a lifetime investment.
Thank you.
Senator Specter. Thank you very much, Dr. Tucker.
AMERICAN FOUNDATION FOR NEGRO AFFAIRS
Mr. Evans. Mr. Chairman, would you permit me to just have
read--just mention a word about the AFNA program. I just want
Dr. Cooper to come up and read about what AFNA is all about.
Senator Specter. Mr. Evans, we're running very late, but
how much time would you need?
Mr. Evans. Well, how much time do you think these kids are
worth? What I'm saying is I took my time to come down here.
Senator Specter. Go ahead, Mr. Evans.
Mr. Evans. Well, I'm saying. Wait a minute--where are you
at, Cooper? Will you come up here? Are you here? Come over
here? Okay, sit down there, Cooper. Let me say this, I want to
say this. We are never going to solve a program in a colonial
system where you don't permit to present what you're doing.
Now, I put in some 75, 80 years in this work and real sincere,
and I'm 100 years old and you're going to give me 5 minutes to
explain my work.
So let me come here now and say this. I'm a resident of
America, I'm an American, and I want to see America work. Now I
want Dr. Cooper just to read just what AFNA's doing, read this.
Senator Specter. Would you identify yourself for the record
at the start please?
Mr. Cooper. Reverend Jason Jerome Cooper, member of the
AFNA staff. AFNA national education and research fund, AFNA is
and AFNA is not----
Mr. Evans. Louder.
AFNA NATIONAL EDUCATION AND RESEARCH FUND
Mr. Cooper. AFNA is a scholarship--is not a scholarship or
loan-granting organization, a job placement agency, an
organization that pays students for participation, a guarantee
of admission to college and other professional schools set up
to provide students with summer jobs. AFNA is a non-profit
organization, national in scope with national headquarters in
Philadelphia.
Mr. Evans. You're reading the wrong thing, Reverend.
Mr. Cooper. Designed to assist students in pursuing
professional careers in medicine, law, engineering, computer
science, business through the humanities, through advanced
academic tutorials and apprenticeships directed and supervised
by the professionals. AFNA is working in conjunction with
parochial----
Mr. Evans. Reverend, will you just hold that? You're
reading the wrong paper. Read the other paper, the paper about
14 things. You're reading the wrong paper.
Senator Specter. Mr. Evans, in another minute or two you'll
want to chair this hearing.
Mr. Evans. Well, I'm just saying that----
Senator Specter. You may have him read the other paper if
you promise not to run for the Senate, Sam.
Mr. Evans. We have turned out some 800 medical doctors, 700
lawyers.
Senator Specter. Go ahead, sir.
Mr. Cooper. Mr. Chairman, the paper that he's----
Mr. Evans. You were reading the----
Mr. Cooper. I'm sorry. AFNA national education and research
fund is beyond the concepts of specialization and the frontiers
of knowledge: integrated concepts, science, philosophy, and
education, by Samuel London Evans. The frontiers of knowledge
in integrated concepts of science, philosophy, and education is
eliminated from the established schools of learning that
propagates specialization. Therefore, the curriculum is limited
to only one of the following subjects: (1) philosophy of
education; (2) basic concepts of modern physics; (3) theory of
values; (4) nature of mathematics; (5) anthropology; (6)
astronomy; (7) paleontology; (8) stars and nebulae; (9) the
world of crystal; (10) direct implicit in the structure of
earth; (11) gestalt psychology; (12) the nature of aesthetics;
(13) signs, symbols, and personalities; (14) laws of density;
(15) the nature of meteorology.
In this connection, Mr. Chairman, students are limited only
to one of the above subjects that are recognized as educated
models. However, AFNA program serves in two or more capacities.
One, the AFNA plan prepares the student to meet the academic
requirements of the school he or she attends in order that they
may pursue professional careers in medicine, law, computer
science, business and commerce, to the humanities.
Two, beyond this AFNA students are privileged to learn and
study the entire basic structure of the frontiers of knowledge
in integrated concepts of science, philosophy, and education.
Three, professors and educators will lecture on one of the
15 subjects before mentioned, and in this connection the
student will receive a copy of each lecture and be required to
take it home for study and review. Students then are required
to rewrite the lecture with the cooperation of their parents
and qualified neighbors all assisting the student. He or she
will then bring copies back to class for evaluation in
completion, spelling neatness, and so on.
This means, Mr. Chairman, the total experience will bring
academic surroundings back into the home and made available to
the family and the community for study and review with the
desire to expand the concept of academic scholarly learning in
the home and on the community level.
Four, in this connection, students are required to keep
copies of each of the 15 lectures for it is hoped that each
student will complete written studies of the 15 subjects from
7th grade through high, college, and graduate school. Indeed,
such an achievement would place the students on the high
rarefied academic platform that holds less than 7 percent of
the world's scholars.
Five, AFNA is not a school----
Senator Specter. You now have 1 minute left on the time
allocated by Chairman Evans.
EVALUATION OF AFNA
Mr. Cooper. Let me then go to evaluation of the program by
Dr.--by Dr. Katcher, The Mithras Group, Aaron N. Katcher,
University of Pennsylvania. In this connection, we know no
doubt--doubt comes from the thought that you could be doing
better. Well intended, even satisfying efforts is not always
effective. Are the courses in AFNA the right ones? Should AFNA
students be spending their time in the laboratory or are they--
are they right for the student? Is it the best model for the
supplementary minority education program?
In describing the model, we also describe how we displayed
that model to a succession of audiences in pursuit of critical
commentary. The conference of educators with interest in
minority problems convened in Philadelphia and New Orleans, and
the Association for Higher Education in Chicago. They
discovered at all of these meetings the model was exposed for
evaluation. If there were anything better to be added from
these various organizations the participants in the program
should be doing, none present were able to----
Senator Specter. Reverend Jason Cooper, we have to move on.
Thank you very, very much.
STATEMENT OF PAUL G. VALLAS, CHIEF EXECUTIVE OFFICER,
SCHOOL DISTRICT OF PHILADELPHIA
Senator Specter. Dr. Paul Vallas, will you resume your
place at the table? Thank you very much. We turn now to the
distinguished chief executive officer of the School District of
Philadelphia, Mr. Paul Vallas.
Prior to coming to Philadelphia, he was the chief executive
officer for the Chicago public schools, and we were very lucky
to kidnap him from Chicago. He received his undergraduate and
master's degree from Western Illinois University, was in the
Philadelphia Inquirer just this morning on the issue of single
sex education separating young men and young women, and said he
wasn't going to adopt it until he found community support, so
that's a sage approach. Mr. Vallas, you've waited a long time.
Now the floor is yours.
Mr. Vallas. It's always a pleasure to follow my colleagues
and, of course, the great Dr. Evans and the great Dr. Tucker.
I'll be very quick because we've really covered just about the
same territory. First of all, I'm a strong supporter of No
Child Left Behind. I think No Child Left Behind is bringing the
accountability measures that are long overdue, and I'm not
afraid to test and I'm not afraid to disaggregate the data,
because I think the disaggregation of data, while it's created
a great degree of consternation among many, it's long overdue
because it really identifies the underachievement that exists,
not only in large urban schools but in rural districts and
suburban districts and even some of the more affluent
districts. And I think by focusing attention on those who are
being underserved, I think it forces us to be held accountable.
NO CHILD LEFT BEHIND
You know, No Child Left Behind has four objectives. One is
to provide children with more choices if they're in
underperforming schools--oh, sorry about that. Should I start
over? Just joking. Two, to provide supplemental education
services for children who can have no choices other than their
neighborhood school. Three, to reorganize those schools that
are consistently academically failing. And four, to make sure
you've got certified teachers.
Now, clearly, while all of these goals pose in many
respects much greater challenges for smaller districts,
particularly districts with only one to two school districts,
these goals, at least among the larger districts, are
achievable, and rather than to go into how we've worked to
comply with those goals, I'll just refer you to my written
testimony that I've submitted with the attached materials to
the committee.
STANDARDS, CURRICULUM, AND TESTING
I will tell you this, though. In terms of testing and
holding children to standards, I've always felt that if you
understand what the standards are and your curriculum and
instruction is aligned with those standards and the test that
you subject your children to, are testing children to those
standards, then every day that you deliver quality curriculum
instruction, you are in fact teaching to the test.
So, you know, the--our move towards obviously embracing not
only standardized tests but our own turnover test in our
revamping of our curriculum and our aligning of our curriculum
and instructional models to the State standards are increasing
the amount of time on tests spent helping children learn to
those standards providing supplemental services.
In our data-driven instruction, in which case we evaluate
our children's progress every 6 weeks and then we make
adjustments in that instruction so that we can do what we need
to do to bring them to those standards. You know, I'm very
comfortable with that. It certainly is creating a lot of
consternation and a lot of anxiety, but, you know, that's good,
because for far too long, at least in our school district,
there has been so much underachievement and there has been a
great degree of neglect.
NCLB ACT AND CHILDREN WITH DISABILITIES
I will say this. Like my colleagues, I share with them the
concern over funding. Let me point out that there has been a 36
percent increase in funding, particularly, I believe, title I
funding, and our district alone has received over $35 million
in additional funding over the past couple of years. Clearly,
the mandates--we need to be doing a better job to fully fund
the mandates. We clearly need to be doing a better job to fully
fund the special education mandate and I certainly think that
some modifications are in order when it comes to the students
with English language deficiencies, as well as with special
education students, because I also agree with my colleagues
that IDEA and No Child Left Behind seem to be in conflict, and
I think the evaluation of special education children should
really be driven by their individualized education plan.
PREPARED STATEMENT
But that said and done, you know, I think the--I think the
act is a tool that sets clear, definable objectives, and I
think it's an act that demands accountability. Certainly
funding is an issue. Funding is always going to be an issue.
Obviously that's where I will continue to focus my attentions
on, but I do want to thank you for this opportunity to speak
and to follow my distinguished colleagues. Thank you so much.
[The statement follows:]
Prepared Statement of Paul G. Vallas
Good morning. Thank you Chairman Specter, Ranking Member Harkin,
and other distinguished members of the subcommittee for this
opportunity to appear before you today. When Senator Specter asked me
to testify here today on Philadelphia's implementation of the No Child
Left Behind Act, I was both honored and humbled to appear. And given
Senator Specter's unyielding support of the School District of
Philadelphia and of education in general, I was delighted to accept his
offer.
Like any broad and sweeping reform of its nature, the No Child Left
Behind Act has certainly drawn a great deal of attention recently.
Passionate advocates both for and against the Act have filled the
airwaves, the newspapers, and sometimes their own backyards with
rhetoric espousing its virtues or deriding its failures. While there is
certainly room for debate on the pros and cons of the Act, there can be
little debate about this fact: there is simply no time to waste when it
comes to setting high expectations for our children, providing the
needed resources for children to meet these expectations, and holding
adults accountable for achieving these expectations. As the head of
America's sixth largest school district, it is my belief that the No
Child Left Behind Act lays the groundwork for accomplishing these
objectives, and I have made every effort to accomplish its mandates.
The chief objective of the Act is closing the achievement gap
between majority groups and minority groups. The greatest tool that
NCLB provides to achieve this objective--and, I suspect, the greatest
object of consternation of some of my colleagues--is the disaggregation
of test scores by subgroup. For the first time, we are able to shine a
spotlight on groups that have been historically underserved. With this
recognition comes our obligation to provide whatever resources we have
to correct this historic imbalance, and the structure of the Act
provides districts with the opportunity to do so.
The School District of Philadelphia has aggressively implemented
all four phases of No Child Left Behind over the past two years. Those
four phases are ``Expanding Comprehensive School Choice Options,''
providing ``Intensive Supplementary Education Services in Low
Performing Schools,'' ``Implementing a Rigorous Corrective Action Plan
for Schools Not Making Adequate Yearly Progress,'' and ``Aggressively
Recruiting Highly Qualified Teachers.'' The handout you have been
given, entitled ``School District of Philadelphia: Programming to
Implement No Child Left Behind Legislation'' details what we have
accomplished under each of these phases, but I would like to draw your
attention to a few highlights.
Under ``Expanding Comprehensive School Choice Options,'' you will
note that the District has 176 out of our 263 schools identified as low
performing schools. With that, over 45,000 students chose to enroll
this year in schools outside of their neighborhood schools. But the
District went beyond the limits of ``choice'' as a decision to be made
between your neighborhood school and a ``higher performing school.'' In
addition to meeting the choice mandates of No Child Left Behind, we
have also formed innovative new school-by-school partnerships with
universities, museums, private managers, and even companies like
Microsoft to manage and assist our lowest performing schools. We have
also seeded our schools with magnet programs, International
Baccalaureate programs, honors classes, dual credit offerings, and
advanced placement courses to provide real choice to our parents. The
School District has enacted a 300 percent increase in the number of
honors and advanced placement courses, because we believe that closing
the ``high achievement'' gap is just as critical as closing the
``remedial'' gap for our children.
Under the provision calling for ``Intensive Supplementary Education
Services in Low Performing Schools,'' the District has targeted
assistance for over 40,000 Grade 1-9 students performing below grade
level in reading and mathematics through the implementation of a
comprehensive extended day academic program in all district elementary,
middle, and comprehensive high schools during the 2003-2004 school
year. The District has also implemented a comprehensive mandatory six-
week summer school academic program in reading and mathematics for over
58,000 Grade 3-10 students not meeting promotion requirements or
performing below grade level. The District has contracted with Voyager,
Princeton Review, and Kaplan to provide the curriculum and the
professional development for these programs.
The second part of your handout deals specifically with
Supplemental Education Services, and I feel it is important to draw
your attention to one problematic provision of NCLB here. As the
briefing indicates, Pennsylvania has approved, and the School District
of Philadelphia has contracted with, 20 providers of Supplemental
Education Services. The District's Intermediate Unit (Pennsylvania's
version of ``Education Service Agencies'') has also been approved as a
provider, so services to low-achieving students through Voyager and
Princeton Review can also receive funding under this provision. I
cannot argue with the spirit of a provision that calls for parents to
be able to choose between different providers for tutoring and support
for their child, and I certainly support a free-market model that has
these providers compete to provide the best services. But as the law
stands, the price is in essence ``fixed'' as a percentage of a
district's Title I budget, so very little can be done in terms of
achieving the most amount of service for the most economical model. To
put it simply, I as a superintendent was faced with the prospect of
serving 12,000 students for 36 hours of instruction at $1,800 per child
or serving 40,000 children for 160 hours of instruction at $300 per
child. Wanting to serve the largest number of children, our District
pursued the IU-provider model, and given that some of the providers in
the Philadelphia area are making 60-70 percent profit on their
services, I felt this to be the most prudent course of action.
Under ``Implementing a Rigorous Corrective Action Plan for Schools
Not Making Adequate Yearly Progress,'' the District has developed a
mandatory, rigorous, and uniform K-12 standards-based curriculum,
instructional delivery models, instructional materials, and aligned
professional development system for low-performing schools. We have
also implemented a uniform district-wide assessment system to
complement the results from our state assessment to provide yearly
benchmarks for district and school accountability. As your handout
indicates, we have provided a number of additional resources to provide
support for our schools lagging behind in AYP. This includes changes in
the management, structure, and organization of low performing schools
that cannot demonstrate improved performance; 49 failing schools in
Philadelphia were restructured with private and charter school
management, 22 comprehensive high schools have implemented 9th grade
academies designed to narrow the achievement gaps of students below
grade level in reading and mathematics, and a number of failing middle
schools have been converted into neighborhood K-8 magnet and high
school programs.
Finally, the District has wholeheartedly embraced the provisions
requiring the ``Aggressive Recruitment and Retention of Highly
Qualified Teachers.'' Under our Campaign for Human Capital, the
District hired over 1200 new teachers this year working with programs
like Troops for Teachers, Teach for America, our retired teacher
program, and aggressive recruitment and retention practices. Even in
spite of a substantive class-size reduction in grades K-3, which
necessitated the hiring of an additional 400 teachers, we met our
hiring objectives and opened the school year with almost no teacher
vacancies.
The School District of Philadelphia has chosen to aggressively
implement the No Child Left Behind Act because its tenets are sound and
its goals are clear: we must do all that we can to ensure that all of
our children are reaching their full potential. There is certainly room
for improvement, however. While no one should deny that meaningful
increases in federal education funding have been achieved under No
Child Left Behind (a 36 percent increase since 2001), providing more
Title I resources, which can be used rather flexibly to support proven
successful practices like reduced class size and after school
assistance, should be a priority. Providing transportation resources
for choice programs, which for Philadelphia has meant more than $7
million in additional costs, would be a welcome assistance. Moving
closer to a 40 percent funding of special education versus the current
18 percent funding is critical as disaggregated data shows how woefully
inadequate our special education resources are. And complementing a
standards and accountability movement such as the No Child Left Behind
Act with a desperately needed school construction assistance program
would be a smart investment in districts like Philadelphia whose walls
have sometimes fallen faster than our test scores in past years.
While we can't shortchange our children by failing to fund reforms,
neither can we hold their futures hostage by waiting for a never-ending
funding debate to resolve itself. The School District of Philadelphia
has demonstrated that substantial education reform can be attained by
using existing resources to fund education priorities. In short, our
philosophy is about sending all available dollars into the classroom.
We will continue to use the tools provided us under the No Child Left
Behind Act to accomplish this, and we will not allow excuses to get in
the way of achievement. Thank you again for the opportunity to provide
comment here today, and I welcome any questions you may have.
School District of Philadelphia Programming to Implement No Child Left
Behind Legislation
EXPANDING COMPREHENSIVE SCHOOL CHOICE OPTIONS
Expand the opportunities for students attending the 176 identified low
performing schools (total number of district schools is 263) to
transfer to higher performing schools
Over 45,000 students choose to enroll in schools outside of their
neighborhood schools:
--Sent 2003-2004 School Choice notifications to families of 127,499
students via mail; as well as posted information on the
district web site, press releases, and public notices to the
media.
--Over 3,000 students will transfer from the district's lowest
performing, highest poverty schools for the 2003-2004 school
year.
--Over 1,000 students transferred as part of a Regional Program for
School Choice from the 10 lowest performing/highest poverty
elementary schools during the 2002-2003 school year.
--Over 11,000 students participate in the district's voluntary
transfer program from 132 racially isolated low performing
schools.
--Over 11,000 students are enrolled in district magnet programs in 13
high performing middle and high schools (over the next five
years a significant number of magnet programs will be
introduced with as many as 15 added during the 2003-2004 school
year).
--Over 19,000 students are enrolled in 46 charter schools (four new
charter schools have been approved for 2003-2004, and an
additional three new charters will open in 2004-2005).
Over 20,000 students are enrolled in the 70 identified new
partnership schools (45 privately managed, 21 restructured by the
district, and 4 new district charters) as part of the school reform
process (over the next five years the number of partnership schools
will continue to increase, with 10 additional schools added in 2003-
2004).
Within the next five years, 11 new magnet high schools will be
constructed (one in each academic region); 14 large middle schools will
be converted to small neighborhood magnet high schools (during 2003-
2004, 6 middle schools will begin conversions).
--Formed partnerships with universities (Drexel, Eastern, Holy
Family, St. Joseph's, and Temple Medical School) to develop new
management structures for low performing high schools.
--Formed partnerships with private and public institutions to enroll
high school juniors and seniors in high performing college
preparatory and school-to-career programs.
Within the next five years, 30 low performing smaller middle
schools will be converted into neighborhood K-8 schools with open
enrollment for students living in that region.
INTENSIVE SUPPLEMENTARY EDUCATION SERVICES IN LOW PERFORMING SCHOOLS
Expand the opportunities for students attending low performing schools
to receive intensified supplementary education services to
significantly improve academic achievement
Implemented aggressively a school readiness campaign (Healthy Kids,
Healthy Minds) for screening and health care support services for
students prior to enrolling in the district's full-day Kindergarten
program, and at appropriate grade levels in compliance with
Commonwealth of Pennsylvania mandates (during 2002-2003, 75 percent of
students screened for vision, 2003-2004 projection: 95 percent; during
2002-2003, 12 percent of students screened for dental, 2003-2004
projection: 75 percent).
Targeted physical and behavioral health care support and case
management services for elementary school students who are performing
below grade level, i.e., establishment/verification of insurance
coverage, medical and dental care homes, behavioral health linkages as
needed, and timely resolution of identified health problems (during
2002-2003, 72 percent of students had documented insurance, 2003-2004
projection: 95 percent).
Implemented a rigorous district-wide promotion/graduation policy as
a means of identifying and supporting students performing below grade
level.
Targeted assistance for approximately 30,000 Grade 3-9 students
performing below grade level in reading and mathematics through the
implementation of a comprehensive extended school day academic program
in all district elementary, middle, and comprehensive high schools
during the 2002-2003 school year.
Contracting with PDE approved providers to administer extended
school day and summer programs including Voyager, Princeton Review and
Kaplan Learning, 21 community based organizations in 11 Beacon School
sites (serving over 1,300 students with 8 new sites in development),
and 17 private providers (offering tutoring services to 4,538
students).
Implementing a comprehensive mandatory six-week summer school
academic program in reading and mathematics for over 58,000 Grade 3-10
students not meeting promotion requirements or performing below grade
level (12,000 students participated in 2002).
--Providing summer programs for over 5,000 English Language Learners
and Special Education students.
IMPLEMENTING A RIGOROUS CORRECTIVE ACTION PLAN FOR SCHOOLS NOT MAKING
ADEQUATE YEARLY PROGRESS
Develop and implement a rigorous accountability system that ensures
academic improvement and sustained growth through a system of
evaluating, monitoring, and providing assistance to low
performing schools
Developed a mandatory, rigorous, and uniform K-12 standards-based
curriculum, instructional delivery models, instructional materials, and
aligned professional development system for low performing schools.
Implemented a uniform district-wide assessment system to complement
the results from the state assessment system (Grades 3, 5, 8, 11 in
reading, writing, and mathematics) and provide yearly benchmarks for
district and school accountability.
--Over 128,000 Grade 3-10 students were assessed using the TerraNova
in reading, mathematics, and science in the fall 2002 to set
district, school, and individual student baselines for academic
performance.
--Over 157,000 Grade 1-10 students were assessed using the TerraNova
in reading, mathematics, and science in the spring 2003 to
measure district, school, and individual student progress for
academic performance from the fall 2002 baseline.
--Over 58,000 Grade K-3 students were assessed quarterly using the
Dynamic Indicators of Basic Early Literacy Skills to measure
and track individual student progress in fluency, phonics, and
phonemic awareness.
--Over 58,000 Grade K-3 students were assessed quarterly using the
Diagnostic Reading Assessment to measure and track individual
student progress using running records.
Developed a rigorous district-wide school performance index to
complement the state NCLB Accountability Plan by tracking school
progress using a variety of indicators including the PSSA, the
TerraNova, student mobility (the district average is 35 percent
annually for each school), student, attendance, teacher attendance,
persistence rates (the percentage of students who do not drop out of
school before graduation), and promotion and graduation rates.
Implemented a rigorous school quality review process to evaluate
the performance of the district's 85 identified lowest performing
schools.
Wrote corrective action plans with mandated timelines and
implementation strategies for the district's 85 identified lowest
performing schools (this includes privatized, charter, and district
restructured school models).
Designed and implemented a uniform process for school improvement
planning for the 2002-2003 school year for all the district's 263
schools, based on the findings from the school quality review process.
Developed procedures for changes in the management, structure, and
organization of low performing schools that cannot demonstrate improved
performance.
Pre qualified up to 5 new private companies to manage additional
low performing district schools.
Restructured 49 failing schools by implementing proven privatized
and charter school models (over the next five years the number of
privatized and charter schools will continue to increase, with 14
additional schools added in 2003-2004).
Restructuring failing middle schools by converting schools into
neighborhood magnet K-8 and high school programs (during 2003-2004, 3
middle schools begin conversions).
Restructuring failing high schools by implementing a rigorous
reform movement that includes converting schools that do not
demonstrate improved performance into neighborhood magnet programs
(during 2003-2004, 22 comprehensive high schools will implement 9th
grade academies designed to narrow the achievement gaps of students
below grade level in reading and mathematics).
Facilitated the implementation of the Accountability Review Council
in cooperation with the School Reform Commission to meet the
requirements of the district reform partnership agreement between the
city and state governments (the ARC will certify the district's reform
results and produce annual report cards measuring the progress of
reform).
AGGRESSIVE RECRUITMENT OF HIGHLY QUALIFIED TEACHERS
Institute the Campaign for Human Capital, a blueprint for the
recruitment, retention, and renewal of a highly qualified
teaching staff
Utilizing alternative recruitment strategies including Teach
America and Troops to Teachers (resulting in the hiring of 145 new
qualified teachers).
Implementing an aggressive strategy to recruit qualified
mathematics and science teachers through partnerships with local
universities such as Drexel University and the Transition to Teaching
Program.
Expanding the Reduced Class Size model from K-2 to K-3 classrooms
to increase the district's pool of highly qualified elementary school
teachers.
Preparing emergency certified teachers for the Praxis examination
by offering classes at Holy Family, Temple, or using an on-line Praxis
preparation course.
Expanding the district's pool of highly qualified elementary school
teachers by assigning former literacy interns who have become certified
to serve as stand alone teachers (it is anticipated that 250 new
teachers will come from this pool).
Developing a competency profile made up of characteristics commonly
possessed by the highest quality teachers as found by a variety of
research methods, including surveys, focus groups, interviews, etc.
Implementing an aggressive marketing campaign to target segmented
groups of high need teacher candidates (African-Americans, males,
critical needs subject area candidates).
Implementing a training program to build the capacity of the
recruitment team by exposing them best practices.
Designing ``Leadership for Retention and Renewal'' professional
development program--that will equip them with the skills and
strategies necessary to support all teachers (rookie, novice and
veteran) in their schools.
Implementing a tuition reimbursement program for teachers beginning
their second year in the district to continue professional development,
thus providing an incentive for ongoing professional growth.
Implementing a comprehensive mandated pre-service training program
all new teachers must attend to ensure their preparedness for entering
our classrooms.
Establishing the position of New Teacher Coach to support newly
hired at teachers at a 10:1 ratio.
Expanding the district's current incentive programs to attract
highly qualified teachers to include a Teacher Ambassador Program
called ``Every Teacher, an Ambassador'' which will provide a monetary
incentive for identifying certified teachers and teachers in hard to
staff positions.
Increasing the number of student teachers by offering a series of
incentives to the student teacher as well as to the cooperating
teacher.
Creating for the 2003-2004 recruitment season a ``Roll Out the Red
Carpet Campaign'' strategy that will attract college juniors and
seniors from our regional colleges and universities to learn about the
benefits of teaching in our schools and living in Philadelphia.
Testing of all instructional paraprofessionals has begun and will
continue until all paraprofessionals meet the requirements of the
statute.
SES PROVIDERS
No Child Left Behind guarantees that students from low income
families who are attending low performing schools will have access to
tutoring services paid for by the School District of Philadelphia. The
Intermediate Unit's program was recently approved by the State as one
of these supplemental providers.
----------------------------------------------------------------------------------------------------------------
Number of hours Cost Students served
----------------------------------------------------------------------------------------------------------------
SES Providers (47 approved by state). 36-40 hours total...... $1,815 per student..... 12,500
Extended Day (using state approved 160 hours.............. $300 per student....... Upwards of 40,000
providers).
----------------------------------------------------------------------------------------------------------------
The District, as required by law, notified parents that they could
choose to use the services of an SES provider by letter on October 24.
The letter included a list of all the SES providers--as well as their
phone numbers--that had submitted their paperwork to the District.
This letter followed up and reinforced an aggressive advertising
program launched by the SES providers themselves back in August.
The SES advertising has been ongoing from August until today.
17,000 students improved their performance between the beginning of
last year and the beginning of this year so that they have moved out of
the bottom quartile, as measured by the Terra Nova. However, these
students are still encouraged to take advantage of the District's
Extended Day program.
Extended Day is being modified from last year to include an hour of
instruction as well as an hour of enrichment activities Monday through
Thursday. The curriculum for instruction aligns with state standards
and directly supports the new standardized curriculum being taught in
all classrooms throughout the District. The second hour, provided in
conjunction with community based organizations, is optional.
There are 30,500 3rd through 8th graders in the District that can
take advantage of the Extended Day program. In fact, the first hour of
Extended Day is mandatory for students in grades 3, 8 or 11 who are
scoring in the bottom quartile, as measured by the Terra Nova.
The objective of the District's Extended Day program is to provide
high quality supplemental educational services to all the District's
children.
To ensure that parents know about that they have this choice, the
School District is sending letters home with students in 192 schools.
Pursuant to federal law, low income families at the 192 schools qualify
for supplemental services.
State approved providers have partnered with the District in order
to provide the high quality Extended Day program. The providers include
Voyager, Princeton Review and Kaplan.
Extended Day--which began October 17 for grades 3-8 and will begin
on December 2 for grades 1, 2 and 9--is able to provide more hours of
instruction and enrichment to more students than supplemental service
providers can because they cost significantly less. For example, the
average cost of Extended Day is about $300 per student for the 20 week
program (up to 160 hours), while the law authorizes comparable
supplemental services for $1,815 per student.
While the District supports the spirit and intent of the federal No
Child Left Behind law, it intends to enforce academic and fiscal
accountability. This will ensure that as many children as possible can
have access to services.
Educational choice for parents and students is actually reduced
when private companies are allowed to make unreasonable profits at the
expense of students. Fewer students can be served and the quality of
the program invariably diminishes.
Senator Specter. Thank you very much, Mr. Vallas. When you
said the thing has already been said, that was a commentary of
a very famous Congressman, Mo Udall, a Democrat from Arizona.
He stood at a speech once after many speakers presented
themselves and he said, everything has been said, but not by
everybody. And on Capitol Hill, it doesn't matter that
everything has been said until everything has been said by
everybody.
This has been a very informative hearing and I want to
thank you for coming from Pennsylvania on short notice. When I
saw the meeting which you had on March 1, just on Monday, it
seemed to me that really ought to attract the attention of the
Secretary and his expert in the field, Mr. Ray Simon. And the
Secretary will meet with you at 2 p.m. and you'll have a little
more time.
Everything that's been said has been transcribed in the
record, and although the Senators come and go because they have
many other committee assignments, the transcript will be read
by staff and your words will be weighed, and I believe that
there will be changes to No Child Left Behind. There will be
modifications made as we go through the learning curve, and
there will be more funding as well.
We have a very tight budget this year, which you all know,
but there are many of us here who, as you said, Dr. Tucker,
consider education an investment. It is not an expenditure, and
when Mr. Evans outlines what he has done for AFNA, we have
recognized that on the Federal funding for many, many years, as
we have recognized what you have done, Dr. Tucker, and what you
are all doing.
So thank you very much for coming. There is no higher
priority on the budget than education and this subcommittee
will pursue it with great diligence.
Dr. Tucker. Thank you, Senator, too, for having us here.
STATEMENT OF SENATOR THAD COCHRAN
Senator Specter. We have received the prepared statement of
Senator Thad Cochran which will be placed in the record.
[The statement follows:]
Prepared Statement of Senator Thad Cochran
Mr. Chairman, I want to welcome the Secretary and thank him for
coming to testify before the subcommittee today, and for his
outstanding service to our nation as Secretary of Education.
I appreciate the Secretary's attention to my state of Mississippi,
which is also his home state. He has honored us with several personal
visits.
I've visited with our State School Superintendent, and a good
number of teachers, principals and parents since the passage of the No
Child Left Behind Act. My impression is that our State has embraced the
concept of accountability and is utilizing the new flexibility that is
built into the programs.
I'm pleased to see the budget proposal for the Department of
Education suggests increases of $1 Billion each for title I grants and
Special Education grants to states. And, I'm pleased that continued
funding is suggested for Ready to Learn Television, Civic Education,
Character Education and other areas of importance. There are some areas
in the budget proposal that eliminate programs that have been important
to individual schools, teachers and assisted the State's efforts in
meeting the requirements of No Child Left Behind. In particular,
proposed elimination for the National Writing Project, Arts in
Education, Gifted Education, STAR Schools, and Foreign Language
programs for K-12 schools draw my attention. I'm concerned about those
areas, and I know we'll work through the appropriations process and try
to meet the needs and interests in my state and across the nation.
ADDITIONAL COMMITTEE QUESTIONS
Senator Specter. There will be some additional questions
which will be submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Arlen Specter
PENNSYLVANIA TITLE I FUNDING
Question. In Pennsylvania 233 of 500 school districts who receive
Title I grants will receive less funding in fiscal year 2004 than they
did in fiscal year 2001, the year before the No Child Left Behind Act
was passed. As a former superintendent, what advice related to carrying
out this important law do you have for the 233 districts in
Pennsylvania that will receive fewer Title I funds in fiscal year 2004
than they did in fiscal year 2001?
Answer. My advice would be that as important as Title I funding is
to local school districts, it is typically a small fraction of overall
funding, and that the reforms in No Child Left Behind are specifically
designed to leverage education spending from all sources, Federal,
State, and local. So the question is not what can or cannot be done
with a Title I allocation, which may be smaller or larger than it was
the year before, but how can we better allocate all our funding to help
ensure that all our students reach challenging State standards.
BUDGET REQUEST AND HIGHLY QUALIFIED TEACHERS
Question. Is the President's budget request for fiscal year 2005
sufficient to meet the requirements of the No Child Left Behind Act,
such as to attract, train and retain ``highly qualified'' teachers,
implement additional testing requirements, and provide more public
school choice and after-school tutoring, in light of the reduction in
Federal funding for these districts?
Answer. We believe Federal funding is more than adequate to meet
the requirements of No Child Left Behind programs. As I mentioned
earlier, success in meeting those requirements depends not primarily on
a particular level of Federal support, but on making better decisions
in the use of combined education funding from Federal, State, and local
sources. I would add that when it comes to testing, the development and
implementation of the additional assessments required by No Child Left
Behind is separately funded through a State grant program, and the
amount of this funding has been going up every year. In addition, not
all districts are required to provide public school choice and
supplemental educational services, just those in which schools have
been identified for improvement, corrective action, or restructuring.
STUDENTS TRANSFERRING TO SCHOOLS NOT IDENTIFIED FOR IMPROVEMENT UNDER
NO CHILD LEFT BEHIND ACT
Question. Based on available information and pending analysis of
consolidated State applications and other State-reported data, the
Department has reported that 5,000 schools have been identified for
improvement and an estimated 2.5 million students are available to
transfer to a public school that is not identified for improvement. How
many of these students have in fact transferred?
Answer. These data will be included in the Department's forthcoming
report on the implementation of key provisions in No Child Left Behind,
which is scheduled for completion and submission to the Congress in
late spring of this year.
TITLE I SCHOOL CHOICE
Question. What is known about whether eligible students and their
parents are choosing to stay in their current school?
Answer. We do not have comprehensive data on this issue, but
preliminary studies carried out by education organizations, as well as
news reports, suggest that the great majority of students eligible to
transfer to another public school do indeed stay in their current
school. Sometimes this is because parents and students are more
comfortable in their neighborhood schools; in other cases it may be
that parents are encouraged by improvement efforts or other special
programs at their current school. In still others, it may be that local
school officials have not done enough to inform parents about available
choices or have not provided that information early enough in the year.
I would add that I see nothing wrong with parents choosing not to
move their children, so long as they receive sufficient information on
the available choices. The point of the public school choice
requirement is that parents and students have options if they are not
happy with their current school, and that no student is forced to
remain in a poorly performing school if there is a better alternative.
BARRIERS TO SCHOOL CHOICE
Question. To what extent do real and perceived barriers prevent
students from exercising the choice option required by No Child Left
Behind?
Answer. I believe it is too early to determine the extent of this
problem. Certainly in the first couple of years of implementing No
Child Left Behind many districts did not aggressively inform parents of
available choice options, and in many cases the fact that options were
made available only after the school year had already started
discouraged students from transferring. We expect, and have already
seen, that such problems diminish over time, as States and districts
improve their procedures and more parents become aware of choice
options.
Question. What specifically does the fiscal year 2005 budget
propose to address these issues?
Answer. Effective implementation of public school choice under No
Child Left Behind is not really a budget issue, and our budget does not
include any specific proposals in this area. As I mentioned earlier, I
believe this is a problem that is being addressed over time. And of
course the Department continues to provide guidance and technical
assistance on public school choice, and to examine choice
implementation as part of its regular Title I monitoring efforts.
REPORT ON NCLB IMPLEMENTATION
Question. The subcommittee understands the Department's report to
Congress, including State and local performance related to No Child
Left Behind, is expected to be available in late spring of 2004. As
soon as it is available, please provide the subcommittee with a copy of
the report.
Answer. We expect that the report will be completed and submitted
to the Congress in late spring of this year.
COSTS OF SCHOOL IMPROVEMENT AND CHOICE REQUIREMENTS
Question. Based on information derived from State reporting and/or
other reliable and appropriate data, what is the Department's estimate
of the funding required to meet all of the requirements related to
school improvement status--public school choice, supplemental services,
school restructuring, etc.--which must be taken with respect to schools
that fail to meet adequate yearly progress standards for 2 or more
consecutive years?
Answer. There is no reliable way to estimate such costs, primarily
because States and districts have great flexibility in developing
school improvement plans, and because costs will vary greatly from
district to district depending on the extent of the problems that are
preventing schools from meeting adequate yearly progress (AYP)
standards. Also, it is not necessarily the case that school improvement
or restructuring requires additional funding. More often, districts
will obtain improved results through better use of existing funding
from all sources--Federal, State, and local--rather than merely adding
new spending or initiatives that tend to ignore problems in core
instructional areas.
Question. Does the fiscal year 2005 budget request provide
sufficient funds to pay the costs of such activities?
Answer. We believe the President's budget request, combined with
funding made available in earlier years as well as State and local
resources, is sufficient to pay for the school improvement requirements
of the No Child Left Behind Act.
FUNDS FOR SCHOOL IMPROVEMENT
Question. Mr. Secretary, the Pennsylvania Department of Education
has indicated that under the No Child Left Behind law, they will have
fewer funds available at the State level for school improvement than
they did in fiscal year 2001, while they have almost three times as
many schools identified as in need of improvement. How will the
Department provide these schools with the additional assistance they
need to improve the academic achievement of students, with fewer
resources?
Answer. It is possible that State-level resources for school
improvement are somewhat lower than under the earlier law, but overall
funding for school improvement efforts, which under No Child Left
Behind is targeted to the district level, greatly exceeds the funding
available for such activities prior to reauthorization. This is because
under the old law, States were permitted, but not required, to reserve
up to one-half of one percent of their Title I allocations for school
improvement efforts. Under No Child Left Behind, beginning in fiscal
year 2004, States are required to reserve 4 percent of their
allocations for school improvement, and to distribute 95 percent of
such reservations to those school districts with the greatest need for
such funds.
To put this change in dollar terms, in fiscal year 2001, States
might have reserved as much as $44 million for school improvement. In
fiscal year 2005, under the President's request for Title I, they will
be required to reserve more than $500 million for this purpose.
Congress did provide, in appropriations language, separate funding
for school improvement, including the provision of public school choice
options, in fiscal years 2000 and 2001. Even these amounts--$134
million in 2001 and $225 million in 2002--were significantly below the
levels provided under No Child Left Behind.
Question. What other resources are proposed in the fiscal year 2005
budget to assist schools trying to improve the academic achievement of
all students, particularly those schools identified as in need of
improvement or on watch lists?
Answer. There are no specific proposals for additional school
improvement-related funding in our budget, both because we believe the
Title I reservation is sufficient and because, in a larger sense, all
of our programs provide funding that is intended to help schools
improve the academic achievement of all students.
SUPPLEMENTAL SERVICE PROVIDERS
Question. Has the Department compiled any evidence that third-party
supplemental services providers are more successful than their regular
public schools in providing Title I services?
Answer. No, we do not yet have any performance data on supplemental
service providers. What we do know is that Title I, as operated by
regular public schools over the past four decades, has largely failed
to improve achievement for participating students. No Child Left Behind
is trying to change this rather unimpressive record, and we believe
third-party providers will be able to make a contribution in this
effort, particularly for low-income students in schools that
consistently do not make adequate yearly progress.
CHOICE AND SUPPLEMENTAL SERVICES
Question. What information is available about the timeliness and
effectiveness of communication to parents of affected pupils eligible
for public school choice and supplemental services options?
Answer. Preliminary studies and other early evidence suggests a
mixed record by districts in communicating No Child Left Behind choice
and supplemental service options to parents. In part this reflects the
usual difficulties encountered in doing something new, and we have seen
districts improve over time. And, unfortunately, it also reflects at
least occasional reluctance by districts to fully comply with the
requirements or spirit of the new law.
Question. Are parents typically being offered a substantial range
of choices?
Answer. Based on the limited information we have, most districts
are complying with the law, which requires a choice of more than one
school. This is not the same as a ``substantial range of choices,'' but
the law and our regulations do give districts some flexibility in this
area, in order to take into account geographic limitations and allow
LEAs to make efficient use of transportation resources.
Question. Have any localities received waivers from the requirement
to provide supplemental services; if so, how many have been provided?
Answer. Such waivers may be approved by State educational agencies
only if there are no available service providers and the school
district itself is unable to provide services. We do not have data on
waivers that SEAs may have granted.
MATHEMATICS AND SCIENCE PARTNERSHIPS
Question. The fiscal year 2005 budget proposes to override the No
Child Left Behind Act authorization for the Math and Science
Partnerships program in order to administer a new competitive grant
competition focusing solely on math instruction for secondary education
students. How is this proposal consistent with Goal 2 and objectives
2.2 and 2.3 identified in the Department's fiscal year 2005 Performance
Plan related to math and science achievement, when additional funds may
only be used for math instruction in secondary schools?
Answer. The Administration believes that it is critical to fund
efforts specifically to accelerate mathematics learning at the
secondary level by helping secondary students master challenging
curricula and by increasing the learning of students who have fallen
behind in mathematics. Research indicates that many students who drop
out of school lack basic skills in mathematics, and our Nation needs to
support these students so that they can catch up to their peers and
stay in school.
Question. Where does the Department find any congressional intent
for it to run a separate $120 million grant program focusing only on
math instruction and reduce State flexibility to target funds to areas
of greatest need?
Answer. It is not at all unusual for a President to identify
critical educational needs and, in between the periodic congressional
reauthorizations of major education laws, propose either modifications
to existing programs or even entirely new programs to address such
needs. It also is not unusual for both the President and the Congress
to emphasize one part of a law over another. In the case at hand, the
President believes there is good reason to give priority to improving
math instruction. Moreover, he is proposing to use new money to pursue
this priority, thus preserving State flexibility in the use of existing
funding.
STUDENTS' SCIENCE ACHIEVEMENT
Question. Since annual science assessments will be required under
NCLB beginning in the 2007-2008 school year, won't this new grant
program designed only to improve math achievement curtail efforts to
improve science achievement?
Answer. Since we are proposing to use new money for the President's
proposal to improve math instruction, I do not see how this would
``curtail'' current efforts to improve science achievement. In
addition, since mastery of basic mathematics is often a prerequisite
for learning most sciences, I believe it is reasonable to argue that
the President's proposal may well have the additional benefit of
contributing to improved science achievement.
FUNDS FOR ASSESSMENTS REQUIRED BY THE NCLB ACT
Question. To date, the Congress has appropriated more than $1,161
million to assist States with the development and implementation of
additional assessments required by the No Child Left Behind Act and the
fiscal year 2005 budget request includes $410 million for such
authorized activities. The General Accounting Office, National
Association of the State Boards of Education and other organizations
have developed different estimates for the costs associated with the
additional assessment requirements of No Child Left Behind. Is the
Department confident that funding provided at the proposed fiscal year
2005 level--in addition to funds already appropriated--would be
sufficient to meet the additional assessment requirements of the No
Child Left Behind Act? If so, please provide the subcommittee with the
specific evidence used by the Department to reach this conclusion.
Answer. We believe that the funding provided under the State
Assessment Grant program, in addition to being fully consistent with
the congressional authorization level and the ``trigger amounts'' in
the law, is sufficient to pay for the costs of developing and
implementing the new assessments required by No Child Left Behind.
These costs vary considerably, of course, depending on such factors
as the grades covered by a State's existing assessment system, the
number of students tested, and the types of assessments used. This is
why the cost estimates developed by differing organizations also vary
considerably. Under these circumstances, and particularly in view of
the fact that such costs were not separately funded under the previous
law, we believe that No Child Left Behind funding for assessments
reflects a reasonable and responsible approach to paying for the new
assessments.
GRANTS FOR ENHANCED ASSESSMENTS
Question. Within the amount provided for assessments, more than $21
million has been used for activities authorized under the Grants for
Enhanced Assessments Instruments program. Specifically, what projects
have been funded to assist States with meeting the challenge of
developing and implementing appropriate alternate assessments for
students with disabilities and for developing and implementing
assessments for English language learners?
Answer. So far the Department has made nine grants under this
program using approximately $17 million from fiscal year 2002 funds. A
competition to award $4 million from fiscal year 2003 closed on April
5, 2004. The Department estimates that it will make 6 grant awards from
these funds.
ENHANCEMENT OF ASSESSMENT PROJECTS FOCUS ON STUDENTS WITH DISABILITIES
AND STUDENTS WITH LIMITED ENGLISH PROFICIENCY
The nine current projects, which are awarded to States or consortia
of States, focus on enhancement of assessments for students with
disabilities and students with limited English proficiency. Four
projects focus on the assessment of English proficiency, two focus on
appropriate test design and accommodations for LEP students, one
project examines appropriate accommodations for special education
students, one aims to improve the technical quality of alternate
assessments for students with severe disabilities, and one project will
enhance State capacity to evaluate and document the alignment between
State standards and State assessments.
Below is a short summary of each Grants for Enhanced Assessments
project:
Lead State: Utah Collaborators: Montana, Idaho, New Mexico,
Colorado, Oregon, Wyoming, and North Dakota
Grant amount: $1,842,893
Summary: The project aims to develop a series of assessments of
English language proficiency at four levels (K-3; 4-6; 7-9; 10-12) to
enable teachers to diagnose the proficiency level of English language
learners (ELLs).
Lead State: Rhode Island
Collaborators: Maine, New Hampshire, and Vermont
Grant amount: $1,788,356
Summary: The project will build upon an existing collaboration
among Maine, New Hampshire, Rhode Island and Vermont and will help
compare progress across States and combine resources to develop the
highest quality assessments. States will examine the impact of
computer-based testing accommodations on the validity of test scores
for students with and without special needs, and train teachers to
create and use the assessments.
Lead State: South Carolina
Collaborators: American Association for the Advancement of Science,
Austin (Texas) Independent School District, The Council of Chief State
School Officers, District of Columbia Public Schools, Maryland, and
North Carolina
Grant amount: $1,719,821
Summary: The project will help gather valid information about ELLs'
academic knowledge and skills, and matching ELL students with the
proper accommodations based on their testing needs.
Lead State: Oklahoma
Collaborators: Alabama, California, Delaware, Kansas, Louisiana,
Massachusetts, Minnesota, New Jersey, North Carolina, Pennsylvania,
South Carolina, Texas, Wyoming, West Virginia, and Wisconsin
Grant amount: $1,442,453
Summary: The project will work to expand and automate a process for
judging the alignment of assessments with content standards, serve
students with disabilities and help link assessments across grades. The
alignment process system will be available on a CD-ROM that can be
readily distributed to States to increase the use of the alignment tool
in assessment development and verification.
Lead State: Nevada
Collaborators: Indiana, Iowa, Kentucky, Louisiana, Massachusetts,
Michigan, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, South
Carolina, Texas, and West Virginia
Grant amount: $2,266,506
Summary: The project will help States implement assessments to
measure the annual growth of English language development in speaking,
listening, reading and writing. The project will produce test forms and
an item bank from which States can draw to create test forms that
reflect local needs and characteristics, and will help States predict
ELLs' readiness for English language assessment.
Lead State: Pennsylvania
Collaborators: Maryland, Michigan, and Tennessee
Grant amount: $1,810,567
Summary: This project is designed to help States assess ELLs by
analyzing State standards, establishing content benchmarks and
developing standards-based assessments drawn from scientific research.
The resulting assessments are to be shared with interested States and
districts.
Lead State: Colorado
Collaborators: Iowa, Oregon, Illinois, Missouri, South Carolina,
West Virginia, and Wyoming
Grant amount: $1,746,023
Summary: The project will help improve alternative assessments for
students with complex disabilities, and the assessment methods will be
developed, pilot tested and analyzed during the course of this project.
Lead State: Wisconsin
Collaborators: Alaska, Delaware and Center for Applied Linguistics,
Center for Equity and Excellence in Education, Second Language
Acquisition, University of Wisconsin, and University of Illinois
Grant amount: $2,338,169
Summary: This project will develop and enhance assessment
instruments specially designed to measure ELLs' performance and
progress in English proficiency and literacy skills based on State
standards on reading, writing and language arts and alternate
assessments to measure their performance in other academic content
areas.
Lead State: Minnesota
Collaborators: Nevada, North Carolina, and Wyoming
Grant amount: $2,013,503
Summary: This project will develop new tools to measure the
progress of ELLs using technology to pilot language assessment, develop
new methods to organize, collect and score student assessment data and
combine data from multiple measures to improve the evaluation of
student progress over time. Staff development will help teachers use
assessment results to improve instruction and the methods will be
available to other States.
EFFECTIVENESS OF ASSESSMENTS BEING DEVELOPED
Question. Has the Department disseminated information about the
best practices and innovative approaches to high-quality, appropriate
assessment tools developed through this funding stream?
Answer. The first awards under this program were made a little over
a year ago, and it is too early to assess the effectiveness of the
assessments that are under development by the various grantees.
STATEWIDE LONGITUDINAL DATA SYSTEMS
Question. Mr. Secretary, section 208(e) of Public Law 107-279
requires you to ``make publicly available a report on the
implementation and effectiveness of Federal, State, and local efforts
related to the goals of this section, including--identifying and
analyzing State practices regarding the development and use of
statewide, longitudinal data systems . . .'' as well as other required
elements, not later than one year after the enactment of the Education
Technical Assistance Act of 2002. What is the status of this report?
Answer. The Department currently is not preparing the specific
report referenced in section 208(e), but has been pursuing similar
efforts--including the analysis of existing State data systems, the
identification of weaknesses, and highlighting best practices--as part
of our Performance Based Data Management Initiative.
STATEWIDE LONGITUDINAL DATA SYSTEMS NOT REQUIRED BY NCLB
Question. Given the importance of high quality and timely student
achievement data as relates to implementation of No Child Left Behind,
don't you agree with the critical need to assess State systems and
provide evidence of best practices with regard to such statewide
systems?
Answer. I agree that reliable student and school performance data
are essential to reaching the goals of No Child Left Behind, and we are
working with States and school districts on this issue through our
Performance Based Data Management Initiative. This initiative is
focused on the performance data required by No Child Left Behind, and
will consolidate data collection from States, districts, and schools to
both improve data quality and reduce paperwork burdens.
However, the reporting requirements of No Child Left Behind are
almost exclusively concerned with groups of students, rather than
individual students. For this reason, although statewide longitudinal
data systems may be very desirable as a tool to support educational
reform, they are not required to successfully implement the No Child
Left Behind Act.
Moreover, most of the data that would be collected by such
longitudinal systems--such as enrollment, annual assessment results for
individual students, course completion, and SAT and ACT results--is
required for State purposes and not for meeting Federal reporting
requirements.
For these reasons, while I applaud efforts to develop statewide
longitudinal data systems, I believe such systems are primarily a State
and local responsibility.
EDUCATION PROGRAM FUNDS THAT CAN BE USED FOR STATEWIDE LONGITUDINAL
STUDENT DATA SYSTEMS
Question. How does the fiscal year 2005 budget request specifically
support the goal of ensuring that States and school districts have the
knowledge and resources to develop and implement such systems?
Answer. As indicated previously, longitudinal student data systems
are not required by the No Child Left Behind Act, and thus have not
been targeted for specific support in our fiscal year 2005 budget
request. States are free to use Title V, Part A State Grants for
Innovative Programs for this purpose, as well as State Assessment Grant
funding once they have implemented the full range of assessments
required by No Child Left Behind. In addition, the Department is
providing $10 million annually to support the integration of statewide
data systems as part of our Performance Based Data Management
Initiative.
Question. Mr. Secretary, I am informed by the Pennsylvania
Department of Education that it needs $12 million over 3 years to
implement the required system in Pennsylvania and an additional $1
million per year to maintain it. What Federal funding is available for
the Commonwealth to develop the statewide data system required to
support effective implementation of the No Child Left Behind Act?
Answer. Again, while Pennsylvania deserves praise for undertaking
the development of a statewide longitudinal student data system, such a
system goes beyond the data-collection requirements of the No Child
Left Behind Act. And since this system would primarily serve the needs
of Pennsylvania's school districts and schools, finding $12 million
over three years should not be overly daunting for a State that spends
more than $16 billion annually on public elementary and secondary
education.
However, as I mentioned earlier, Pennsylvania could use Title V,
Part A State Grants for Innovative Programs funding, as well as State
Assessment Grant funding once it has implemented the assessments
required by No Child Left Behind, to support the development and
implementation of its statewide longitudinal student data system.
PELL GRANT MAXIMUM
Question. The President's fiscal year 2005 budget proposes to
establish $4,050 for the Pell Grant maximum award, the same as fiscal
year 2003 and fiscal year 2004. If adopted, this would mean three
years, consecutive years at this maximum grant level. According to the
College Board, tuition for 4-year private colleges has gone up more
than 5 percent for the third year in a row; and for public 4-year
universities, tuition has increased by more than 13 percent this year.
I would also note that research has demonstrated that low-income
students are not as successful in completing their postsecondary
education because they often attend school part time, work long hours,
and borrow heavily.
Mr. Secretary, doesn't your proposal to maintain the current
maximum Pell Grant at $4,050 for fiscal year 2005 mean that students
served by the program will lose ground relative to the price of
postsecondary education?
Answer. We share your concern about the increasing cost of higher
education. Our primary goal, however, must be to secure the financial
stability of the Pell Grant program, the cornerstone of Federal student
aid. Raising the maximum award without adequate funding would
exacerbate the program's funding shortfall, currently estimated at $3.7
billion by the end of award year 2004-05. The Administration's 2005
budget would increase Pell Grant funding by over $800 million to fully
fund the cost of maintaining the current $4,050 maximum award. The
Administration is committed to working with Congress to eliminate the
shortfall and place the program on a firm financial footing.
COLLEGE ENROLLMENT GAP
Question. What other support is proposed in the President's budget
to reverse the increasing college enrollment gap between low- and high-
income students?
Answer. The Administration's Enhanced Pell Grants for State
Scholars proposal is one way the President's budget addresses this
issue. Research consistently shows students who complete a rigorous
high school curriculum are more successful in pursuing and completing
postsecondary education. The Administration's proposal will encourage
additional States and their local governments to participate in the
State Scholars program, encouraging low-income students to successfully
complete these programs.
The Administration also supports strong academic preparation for
postsecondary education and training through the Federal TRIO and GEAR
UP programs. The Administration is proposing in fiscal year 2005 to
spend $1.13 billion dollars for these two programs. In addition, the
Administration is doubling support for the Advanced Placement Program.
Low-income students who participate in Advanced Placement programs,
which give students the opportunity to take college-level courses in
high school, are much more likely to enroll and be successful in
college than their peers. These programs also serve as a mechanism for
upgrading the entire high school curriculum for all students. The
Administration is proposing a $28 million increase for the Advanced
Placement program authorized in the No Child Left Behind Act, bringing
spending on it to nearly $52 million a year.
LEVERAGING EDUCATIONAL ASSISTANCE PARTNERSHIPS
Question. Why does the fiscal year 2005 budget propose to eliminate
the $66.2 million in funding for the Leveraging Educational Assistance
Partnerships program--which helps States establish and expand need-
based student aid programs--despite the fact that it is the only
Federal program designed to expand the amount of need-based student aid
provided by States?
Answer. When the Leveraging Educational Assistance Partnerships
(LEAP) program was first authorized as the SSIG program in 1972, 28
States had undergraduate need-based grant programs. Today all but two
States have need-based student grant programs. State grant levels have
expanded greatly over the years, and most States significantly exceed
the statutory matching requirements. For academic year 2002-2003, for
example, estimated State matching funds totaled nearly $1 billion. This
is more than $950 million over the level generated by a dollar-for-
dollar match, and far more than would be required even under the 2-for-
1 match under Special LEAP. This suggests a considerable level of State
commitment, regardless of Federal expenditures.
PELL GRANT COST ESTIMATES
Question. The Administration has proposed a budget process reform
that would change budget scoring with respect to the Pell Grant
program. For the last three fiscal years, what was the difference
between program costs (displayed by academic year) for the Pell Grant
program as estimated in the President's Budget, and at the time of the
Mid-Session Review?
Answer. The requested information is shown in the following table.
----------------------------------------------------------------------------------------------------------------
Est. program cost Est. program cost
Fiscal year Award year Max award President's mid-session Difference
proposed budget review
----------------------------------------------------------------------------------------------------------------
2002........................... 2002-03 $3,850 $9,582,000,000 $9,531,000,000 ($51,000,000)
2003........................... 2003-04 4,000 10,863,000,000 11,442,000,000 579,000,000
2004........................... 2004-05 4,000 11,410,000,000 12,133,000,000 723,000,000
----------------------------------------------------------------------------------------------------------------
MID-SESSION REVIEW REESTIMATES OF PELL GRANT PROGRAM COSTS
Question. For the same period, what were the differences between
the assumptions used in the President's budget and those available at
release of the Mid-Session Review?
Answer. In general, the Administration revises its applicant growth
assumptions for Mid-Session Review in June based on updated operational
data, including actual information for the current academic year. For
the last three years, the Administration adjusted its applicant growth
assumptions for Mid-Session Review to account for unanticipated
increases in Pell applicants, increasing estimated costs over the
President's Budget level. Other technical assumptions used to estimate
program cost--such as changes in Federal tax provisions, mandatory
updates to the Need Methodology Tables, and proposals to verify
applicants' income data with the IRS--were either revised or introduced
during this update period. In addition, government-wide economic
assumptions used for Mid-Session Review typically differed from those
used in the President's Budget.
ACCURACY OF DEPARTMENT'S PELL GRANT COST MODEL
Question. Has the Department ever accurately estimated the program
cost of the Pell Grant program?
Answer. Historically, the Department's Pell Grant cost model has
been a reasonably accurate predictor of program costs. Over the last 10
years (academic years 1994-95 through 2003-04), the model's estimates
were within an average of 4.6 percent of actual costs. A review of
annual data indicate the forecasting model is particularly reliable
during times of economic stability and less so during other periods.
Estimation in this area is particularly challenging due to the lead
time necessary to produce the President's budget--up to two full years
before the beginning of the funded academic year--and the economic
changes occurring during that period.
Question. What actions has the Department taken to improve its
ability to more accurately forecast the cost of the Pell Grant program?
Answer. Since one of the key components in forecasting the cost of
the Pell Grant program is projecting applicant growth in future years,
the Department is working to build better and more robust tools for
forecasting applicant growth. Over the past three years, the Department
has made ongoing improvements to its primary Pell Grant cost model by
expanding the sample sizes of applicants and recipients, incorporating
real-time disbursement data, and by auditing key technical parameters.
INTERNAL REVENUE SERVICE DATA MATCHING
Question. The Administration has again proposed to allow the IRS to
match income tax return data against student aid applications, in order
to reduce the number of erroneous student aid payments. According to
the U.S. Department of Education, this proposal would save the Federal
Government $50 million in erroneous payments during the 2005-2006
academic year and substantially more in subsequent years. What is the
status of efforts to enact authorizing legislation?
Answer. We have worked closely with the Treasury Department and the
Office of Management and Budget in developing this proposal. The
Administration's unambiguous support is clearly shown in the August 9,
2002, letter signed by Secretaries Paige and O'Neill and OMB Director
Daniels transmitting the proposed legislation to the Congress.
Recently Congressman Johnson introduced H.R. 3613 the ``Student Aid
Streamlined Disclosure Act of 2003,'' which was referred to the
Subcommittee on Oversight of the Ways and Means Committee. There is
general support for the concept, and we are currently working to
address specific operational concerns.
steps taken to reduce erroneous federal student aid education payments
Question. What other steps is the Department taking to reduce and
eliminate erroneous Federal education payments?
Answer. The Department has implemented a multi-year effort to
research the causes of, and to suggest solutions to, incorrect student
payments. We have substantially increased the number of student aid
applications submitted using FAFSA on the Web. The online student aid
application substantially reduces errors and improves services to
students. The Department retargeted the verification selection criteria
to focus on the Pell Grant program and is encouraging schools to verify
all selected applicants. To ensure that verification occurs, the
Department is conducting a series of community outreach sessions on
student aid application verification processes. Finally, we have taken
steps for improving the Department's compliance and monitoring
techniques in the Federal Student Aid and Office of Postsecondary
Education programs.
NEW PROGRAMS VERSUS PROGRAM ELIMINATIONS
Question. Mr. Secretary, in response to a question I submitted last
year, you stated, ``the Administration believes it is more effective to
deliver scarce Federal education resources to States and school
districts through large, flexible formula grant programs rather than
small, categorical grant programs mandating particular approaches to
educational improvement.'' I agree with this general proposition.
However, I note that you have proposed in the fiscal year 2005 budget,
6 new programs that would provide separate funding through categorical
grant programs that support a narrow purpose. At the same time, the
fiscal year 2005 budget request proposes to eliminate 38 categorical
grant programs funded at more than $1.4 billion last year, ranging from
the Smaller Learning Communities program to Arts in Education, because
your Department believes that in many instances these programs have a
narrow or limited effect.
Will you explain your rationale for requesting funds for new
programs proposed in the fiscal year 2005 budget, which have a very
narrow purpose, but not those you propose to eliminate because of their
limited objectives?
Answer. The Administration does not oppose all categorical grant
programs, nor have we proposed to eliminate funding for all of them. We
recognize that such programs often serve an important purpose, such as
calling attention to unmet needs, stimulating innovation, or
demonstrating specific educational strategies. What we have objected
to, particularly in the current budget environment, is the continued
funding of such programs long after they have achieved their
objectives, when they duplicate other funded activities, or when it has
become clear that the funded strategies are not an effective use of
taxpayer funds.
I believe our 2005 request is entirely consistent with this
approach, as reflected in our budget documents, which clearly identify
the rationale for a handful of new categorical programs while proposing
to terminate separate funding for a much larger number of similar
programs that have largely achieved their original purposes. I would
add that, in most cases, these latter programs may be funded under
broader, more flexible State grant authorities if desired by States and
local school districts.
CENTER FOR CIVIC EDUCATION'S WE THE PEOPLE PROGRAMS
Question. Mr. Secretary, the fiscal year 2005 budget proposes
funding for the Center for Civic Education's We the People (WTP)
programs. These programs have been very effective through the years in
providing students with the knowledge, skills, and attitudes they need
to be effective citizens, and evaluations continue to testify to the
success of these programs. Would you agree the WTP programs can be an
antidote to the cynicism and apathy toward politics and government that
persists among young people today?
Answer. We agree that civic education programs can play a critical
role in equipping young people with the knowledge and skills necessary
for effective citizenship. Civic Education is a clear Administration
priority. Although the Department has not conducted any evaluations of
the Center for Civic Education's We the People programs, recent studies
suggest that quality civic education programs may prompt students to
understand, care about, and act on core citizenship values. Quality
civic education programs can also help schools and communities maintain
safe and inclusive learning environments that foster increased social
responsibility and tolerance.
INCREASE FOR RESEARCH, DEVELOPMENT, AND DISSEMINATION
Question. The fiscal year 2005 President's budget acknowledges the
importance of evidence-based decision making in education, yet proposes
to eliminate funding for many of the programs that provide this
information to SEAs, LEAs and teachers themselves. On the one hand you
ask for an increase in Research, Development and Dissemination. At the
same time the fiscal year 2005 budget proposes to eliminate funding for
the Regional Educational Labs, the Eisenhower Math and Science
Clearinghouse and the Regional Technology in Education Consortia. Can
you please comment on these proposals?
Answer. The requested increase for Research, Development, and
Dissemination is not an indication that the Administration proposes to
shift funds from technical assistance to research. Instead, the
Administration recognizes the fact that although the No Child Left
Behind Act mentioned scientifically based research 111 times, there are
significant gaps in our scientific knowledge in many of the areas in
which Congress instructed that funding decisions and practice should
adhere to scientifically based research, including math, science,
school-wide reform models, early literacy programs in preschools, and
professional development of teachers. Our request for increased funding
would support rigorous research to give education practitioners the
information they need to ground their decisions and practices in strong
evidence of what works.
In the conference report accompanying the Consolidated
Appropriations Act of 2004, the conferees strongly urged the Department
to hold a competition for the new comprehensive centers authorized
under sections 203 and 205 of the Education Sciences Reform Act of 2002
(ESRA). In the budget request for fiscal year 2005, the Administration
requested funding under the School Improvement account to support a
competition for the new comprehensive centers. The new comprehensive
centers would provide much-needed training, technical assistance, and
professional development in reading, mathematics, and technology to
States, local educational agencies, and school in order to improve the
academic progress of disadvantaged students, boost teacher quality, and
improve English fluency among students with limited English
proficiency.
Under section 205 of the Educational Technical Assistance Act of
2002, the Comprehensive Regional Assistance Centers, the Regional
Technology in Education Consortia, and the Eisenhower Regional
Mathematics and Science Consortia were only authorized to continue
until the comprehensive centers authorized under section 203 are
established. Since the Department plans to hold a competition for the
new comprehensive centers in 2005, there would be no authority under
which to request funds to continue awards to the existing technical
assistance providers.
REGIONAL EDUCATIONAL LABORATORIES PROGRAM
The Administration did not request funds for the Regional
Educational Laboratories program because there is no evidence that the
laboratories consistently provide quality research and development
products or evidence-based training and technical assistance. Although
the Education Sciences Reform Act of 2002 reauthorized the program, the
current authority does not enable IES to ensure that all of the
laboratories adhere to standards of scientific quality needed to
produce evidence with which to inform decisions.
ARTS IN EDUCATION
Question. The No Child Left Behind Act recognizes the arts as a
core subject of learning. Studies show that the arts are proven to help
close the achievement gap and improve essential academic skills. If
arts have been proven to be essential to the learning process, why does
the fiscal year 2005 budget propose to eliminate the arts in education
program?
Answer. The Administration's fiscal year 2005 budget eliminates 38
small categorical programs that have narrow or limited effect,
including the Arts in Education program, to help increase resources for
high-priority programs. Districts seeking to implement arts education
activities can use funds provided under other Federal programs. For
example, districts can use the funds they receive through the State
Grants for Innovative Programs to implement arts programs.
In addition, under the Improving Teacher Quality State Grants
program, districts may use their funds to implement professional
development activities that improve the knowledge of teachers and
principals in core academic subjects, including the arts. Also,
districts are able to supplement the amount of funding they receive for
these two programs by exercising their options under the
transferability authority of the State and Local Transferability Act.
21ST CENTURY COMMUNITY LEARNING CENTERS
Question. The fiscal year 2005 President's budget proposes to
freeze funding for the 21st Century Community Learning Centers Program.
This is a program that enjoys public and bi-partisan congressional
support. These programs help working families, provide vital additional
academic support to students and provide safe, supervised environments
for kids after school. Is there a reason the Department's fiscal year
2005 budget does not support expanding this program beyond its current
funding level?
Answer. The Administration is proposing to maintain strong support
for the 21st Century Community Learning Centers program by requesting
$999.1 million in the 2005 budget. The request recognizes that the
program provides a significant opportunity to improve the quality of an
estimated 1,800 after-school programs that the program is able to
support. At the same time, we need to ensure that the weaknesses in the
previous program are not carried into the State-administered program.
Preliminary findings from the evaluation of the antecedent program show
a need to focus the program on providing more academic content and
developing a knowledge base about successful academic interventions.
The request also recognizes that the new grantees funded by States
need some time to achieve better outcomes for students, and that
national evaluation and technical assistance activities can play a key
role in successful implementation. The Department continues to provide
technical assistance and intensive outreach to help grantees focus on
program improvement. We also continue to fund rigorous evaluation
activities that will yield program performance information and assist
us in developing new interventions.
NCLB TRANSFERABILITY PROVISIONS
Question. Under the State and Local Transferability Act enacted as
part of the No Child Left Behind Act, States and local school districts
are provided with additional flexibility to target certain Federal
funds to Federal programs that most effectively address the unique
needs of States and localities and to transfer Federal funds allocated
to certain State grant activities to allocations for certain activities
authorized under Title I. How did the Department consider this
authority in making its fiscal year 2005 budget request?
Answer. Our 2005 request maintains high levels of funding for the
programs that are included in the transferability authority (Improving
Teacher Quality State Grants, Educational Technology State Grants,
State Grants for Innovative Programs, and Safe and Drug-Free Schools
and Communities State Grants programs) to ensure that States and school
districts have meaningful flexibility to use Federal funds to address
their own priorities. In addition, the flexibility provided by the
transferability provisions supported the Administration's proposals to
reduce or eliminate funding for small categorical programs, since the
transferability provisions make it easier for States or districts to
identify alternate sources of funding for such programs, should they
wish to continue them.
Question. How will the authority be considered in assessing the
relationship between Federal funding provided and the performance
outcomes achieved with such funds?
Answer. The Department plans to collect information, through
program performance reports and a study of resource allocation, on the
amount of funds transferred among programs under the transferability
authority. As for the relationship between Federal funding and
performance outcomes, we believe that it is often not possible to
isolate the separate impact of many Federal programs on student
outcomes, due to the fact that federal programs frequently seek to
leverage broader State and local improvements in education programs.
However, we will also continue to collect and report information on
trends in student outcomes in order to assess the overall impact of
Federal, State, and local reform efforts on student achievement.
Question. How will this authority shape decisions on future budget
requests for affected programs?
Answer. The transferability authority supports the Administration's
emphasis on rationalizing and consolidating the delivery of Federal
education resources to give States and school districts maximum
flexibility in using these resources to meet local needs, and to
improve student achievement while reducing administrative, paperwork,
and regulatory burdens. As with the 2005 budget request, I expect that
we will work to maintain or increase funding for the flexible State
grant programs included in the transferability authority, while
reducing budget support for smaller categorical programs with limited
impact and more complex administrative requirements.
______
Questions Submitted by Senator Thad Cochran
REPORT ON WRITING BY THE NATIONAL COMMISSION ON WRITING
Question. Mr. Secretary, many teachers in my State, and I know in
other States, have benefited from the very economical professional
development provided by the network of National Writing Project
institutes. Every State is benefiting from the relatively small Federal
investment in the National Writing Project. Many schools report data
that shows measurable improvement in student success in writing who
have been taught by writing project teachers. This is a program that
I've worked for more than a dozen years, to keep authorized and keep
funded.
This past year, the College Board--this is the organization that
administers the college entrance examinations with which we are all
familiar, such as the SAT, established the National Commission on
Writing. It concluded that, ``Writing today is not a frill for the few
but an essential skill for the many.'' Further, it has added to the
college entrance examination a writing section, and it proposes a
concerted effort on retraining teachers in the teaching of writing, and
doing so by increasing the Federal investment in the National Writing
Project. I find this recommendation compelling. These were
professionals, college presidents, and academicians from all over the
country, who looked at the state of student writing and how it was
being taught, and concluded that the best thing the Federal Government
could do to make a positive contribution to improving this condition,
is to increase the funding of the National Writing Project.
Are you aware of the report of the National Commission on Writing?
Answer. Yes, I am familiar with the National Commission on Writing
report, and the important recommendations included in this document. I
agree that writing is an essential learning skill, and that the ability
to write is foundational to other learning areas.
When considering recommendations made in this report, however, it
is important to keep in mind that Richard Sterling, the National
Writing Project's (NWP) Executive Director, chaired the project's
advisory panel. There is no reliable evidence that the NWP is any more
or less effective than other professional development activities. No
impact evaluations of the NWP have been conducted to date. In recent
years, the NWP has sponsored several evaluations of activities
supported under their project. Unfortunately, neither evaluation
approach employed by NWP was sufficiently rigorous to yield reliable
information on the effectiveness of interventions supported through the
program. For example, NWP claimed that the latter evaluation shows
statistically significant gains from baseline to follow-up for 3rd and
4th grade student participants; however, because the study failed to
used control groups or carefully matched comparison groups, it is not
possible to draw any reliable conclusions regarding impact on student
learning in NWP classrooms relative to other classrooms where writing
skills are taught.
ARTS IN EDUCATION
Question. The grants that have been available under the Arts in
Education program have provided nationally recognized school reform in
my State through the Mississippi Arts Commission's Whole School
Program. The Commission received one of the first grants available
under this program and this has been successful as well as provided
arts in schools that otherwise would have none. The benefit of arts
education has been widely reported over the last several years, and I
think we need to continue to allow schools to have a resource that goes
beyond what States and local governments can supply. The Federal funds
that go to States simply do not stretch far enough to allow arts
education to be a priority in schools of high poverty. School
representatives regularly thank me for my support, and in the same
breath, ask for continued funding. This is a difficult situation, but
one I hope we can resolve.
Answer. While the Department plays a significant role in certain
areas of education, all specific decisions about curricula and other
program offerings are made at the State and local levels. Because it is
my understanding that most decisions to reduce or eliminate music and
art programs are driven by budget concerns, I believe there is little
the Department can do in this area, given our relatively small and
necessarily focused contribution to overall education spending. New
flexibility provisions in the No Child Left Behind Act made it easier
for States and districts to support music and arts programs with
Federal dollars, but we recognize that there are many needs competing
for these resources. I do believe that as States and districts make
progress in meeting their proficiency goals for reading and math, they
will devote additional attention and resources to other core subjects
such as music and art.
FEDERAL SUPPORT FOR FOREIGN LANGUAGE INSTRUCTION
Question. In the area of foreign language instruction, the evidence
is that we need to be doing this beginning in elementary schools. It is
my understanding that the small grant program we have to provide
schools with support for this has many more times the applicants than
it can approve. Most schools K-8 do not offer foreign language
instruction, and in States where resources are overburdened, even high
schools are not able to offer even common foreign languages such as
Spanish or French. The point, Mr. Secretary, is that for these schools,
the resource they need is direct access to a Federal grant program.
These programs make a difference in whether or not certain subjects are
taught, and whether or not students have the advantage of a competitive
education.
Answer. I share your view that, in general, foreign language
instruction is important for students who will pursue careers in an
increasingly multicultural world economy. However, both budget
constraints and the limited Federal role in education dictate a focus
on core priorities, and our core priority in elementary and secondary
education lies in helping special populations, such as poor students
and students with disabilities, to meet challenging State standards in
reading, math, and science, as called for in the No Child Left Behind
Act.
I also think that the rebounding economy will permit greater State
and local support for programs such as foreign language instruction--as
well as art, music, and physical education--that suffered most during
the recent recession. Finally, States and school districts may fund
foreign language instruction under larger, more flexible Federal
authorities like Title V State Grants for Innovative Programs.
______
Questions Submitted by Senator Patty Murray
SINGLE SEX EDUCATION
Question. During passage of No Child Left Behind, we reached a bi-
partisan agreement on single-sex education. NCLB says that schools may
provide single-sex programs as long as they are consistent with
``applicable law,''--Title IX and the U.S. Constitution--and requires
the Department of Education to provide guidance on that applicable law.
The law does not direct the Department of Education to change the Title
IX regulations. However, yesterday, you released new proposals to amend
30-year-old Title IX regulations on single sex education.
Current law allows single-sex programs when appropriate, but
contains protections against sex discrimination. The proposed
regulations would dispense with meaningful anti-discrimination
protections and authorize schools to provide alternatives for girls
that fall far short of equality. In the press release announcing this
change, you even admit that research on students' performance in
single-sex education programs is inconclusive.
Shouldn't you be spending that funding and the efforts of the
Department of Education on helping our States implement the No Child
Left Behind Act to close the achievement gap instead of throwing out
long-standing anti-discrimination laws, potentially broadening the
achievement gap for our Nations' girls and boys?
Answer. As required by the new law, we issued guidance on May 8,
2002 on the Title IX requirements related to single-sex schools and
classrooms. At the same time, the Department published a notice that
the Secretary was planning to propose amendments to the existing Title
IX regulations applicable to single-sex education.
The No Child Left Behind Act brought a new emphasis on flexibility
and choice in Federal education programs. Consistent with this
emphasis, the proposed amendments to the Title IX regulations provide
more flexibility to educators to establish single-sex schools and
classrooms in elementary and secondary schools. Research indicates that
single-sex programs may provide educational benefits to some students,
and such programs also offer additional public school choice options to
children and their families.
The Department's proposed amendments continue to require school
districts to afford substantially equal educational opportunities to
both sexes when single-sex classes and schools are offered. Any effort
to provide either sex with alternatives that are inferior to those
provided the other sex would not be consistent with these amendments.
In addition, the proposed amendments require school districts to
ensure that single-sex classes do not rely on overly broad
generalizations about the different talents or capacities of female and
male students. While we acknowledge that there is a debate among
researchers and educators regarding the effectiveness of single-sex
education, we believe our proposal makes educational sense and protects
both girls and boys from discrimination.
SCHOOL CHOICE AND PELL GRANTS
Question. The President's budget yet again includes funding for
vouchers, which were rejected during passage of No Child Left Behind.
The Bush budget includes $50 million for the Choice Incentive Fund and
another $14 million for the DC voucher program, which the Senate never
even voted on.
How can you justify repeatedly abandoning public education by
giving just 1,700 students $7,500 to attend schools that are
unaccountable to students, their families, or the Department of
Education and may not be providing a quality education, when you are
not increasing Pell grants for millions of low-income students past
$4,050 to attend accredited institutions of higher education? This is
especially troubling when so many people are going back to school,
particularly community colleges, for education and training to compete
in this workforce.
Answer. The President's request would increase Pell Grant funding
by over $800 million, to a record $12.8 billion. The Administration
believes there is no contradiction between this strong support for the
Pell Grant program and our proposed modest funding for educational
innovations that expand choice for the parents of elementary and
secondary school students. Both proposals are fully consistent with the
Department's mission and goals; in fact, vouchers and other choice
options are an effort to bring to elementary and secondary education
the same accountability mechanism supported by the Pell Grant program:
allowing students to attend the school of their choice.
STRIVING READERS INITIATIVE
Question. Your budget proposes $100 million for a new program--
Striving Readers--to help improve reading for middle and high school
students. I support efforts to improve our high schools and additional
resources for high schools, including through my Pathways for All
Students to Succeed Act, which provides tools and resources to reform
secondary education.
Isn't it true that overall high schools will be net losers in
funding? Your budget proposes to cut the Perkins Career and Technical
Education program by $300 million, eliminate the $173 million Smaller
Learning Communities program designed to provide more individualized
attention to high school students, as well as eliminate the $34 school-
counseling program. That seems to result in a net loss to high school
students of some $300-400 million. What is the rationale behind that?
Answer. I don't believe that it is correct to say that our budget
results in a net loss of support for high school students. The
Administration has chosen to target scarce resources on programs such
as the Title I Grants to Local Educational Agencies (LEAs) and Special
Education Grants to States, programs that benefit high school as well
as elementary school students, rather than fund small categorical grant
programs with narrow effect, such as the Smaller Learning Communities
and School Counseling programs. Our fiscal year 2005 request would
provide for an increase of 52 percent for Title I Grants to LEAs and 75
percent for Special Education State Grants since President Bush took
office; these programs support our Nation's secondary school students
as well as elementary students.
In addition, our proposal to strengthen and modernize the Federal
investment in vocational education will help States and communities
improve the academic performance of high school students by supporting
effective career pathway programs that promote rigorous academic
curriculum and build a stronger bridge between high schools and
postsecondary and workforce preparation. Further, rather than funding
general expenses like equipment purchases and hiring of staff that have
little direct impact on student learning as we do now, the proposed
``Sec Tec'' program would target funds to partnerships between school
districts and technical schools, community colleges, and other career
pathways programs to ensure that students are being taught the academic
and technical skills necessary for further education and training and
success in the workforce.
FUNDING FOR NCLB PROGRAMS
Question. Your budget for NCLB provides only a 1.8 percent overall
increase. After factoring in inflation and continued enrollment growth
that increase would actually result in a cut in funding for schools.
Further, instead of providing real funding for programs, including
Title I and IDEA, you cut 38 programs and level fund many more.
Since States and schools have been complaining that they need
significant additional resources to meet the many requirements of NCLB,
do you think a cut in funding in real terms is the right approach?
Answer. Over the past decade, overall spending on elementary and
secondary education in the United States has grown from $300 billion to
just over $500 billion. Funding for the Elementary and Secondary
Education Act has more than kept pace with this increase, nearly
tripling from $8.5 billion to $24 billion over the same period.
Moreover, these increases occurred in an environment of historically
low inflation, resulting in very substantial increases in real terms. I
believe these funding levels, along with the President's budget
request, are more than sufficient to pay for the changes called for in
the No Child Left Behind Act.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 9:30 a.m., Thursday, March
25, in room SD-192. At that time we will hear testimony from
the Honorable Tommy Thompson, Secretary, Department of Health
and Human Services.
[Whereupon, at 11:55 a.m., Thursday, March 4, the
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
March 25.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005
----------
THURSDAY, MARCH 25, 2004
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:35 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, Stevens, and Harkin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF HON. TOMMY G. THOMPSON, SECRETARY
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee for Labor, Health, Human Services,
and Education will now proceed.
Our witness today is the distinguished Secretary of Health
and Human Services, Tommy Thompson. Secretary Thompson served
as Governor of Wisconsin from 1987 to the year 2000, the
longest tenure of a Governor in Wisconsin's State history, a
national leader in welfare reform and expanding healthcare to
low-income children and families, served as chairman of the
National Governors Association, the Education Commission of the
States, and Midwestern Governors Conference, bachelor of law
degree from the University of Wisconsin in Madison.
We focus today on the budget of the Department of Health
and Human Services, which has been proposed by the
administration at $62.9 billion, which is an increase of $974
million over the fiscal year 2004 level, or 1.6 percent. And
this is tough year on all accounts, as we know. This budget
proposal has a great many question marks in it, one of which is
the assumed savings of $767 million, all of which are within
the jurisdiction of Finance Committee, but I'm sure Senator
Thompson will drop a letter to the Finance Committee and tell
them to proceed to save that money for us, right, Secretary?
Secretary Thompson. That is correct, sir.
Senator Specter. And the reduction and elimination of about
a dozen programs, which have a lot of support in the Congress--
Article 1 of the Constitution still has that cumbersome
provision about congressional authority to appropriate, and
some of our colleagues take that very seriously on programs
which have been developed over the years. And I take a look at
11 programs which are being zeroed out, and then major cuts.
The Center for Disease Control has a reduction of $116
million, which is a little hard to understand in light of their
increased responsibilities. Every time we turn around, there's
a major problem on SARS or AIDS or bioterrorist threats. And
their building program is in midstream. I visited the Center
for Disease Control several years ago, and was shocked to see
what was going on down there. Your predecessor, Mr. Secretary,
appeared here every year, and never once mentioned the need for
capital improvements at the CDC, and it was in dire need. It's
gone a fair distance on a billion-and-a-half dollar budget, and
I don't know how we can stop it now, but, at the same time, I
don't know how we can not stop it now.
The NIH funding is totally inadequate to allow NIH to go
forward. I know how important that is in your personal agenda.
And I also know you're not the President or the director of
OMB, and you don't structure all of the budgets.
But it looks like a tough year ahead for us, Mr. Secretary.
Secretary Thompson. It is.
Senator Specter. I was hoping to finish before the
distinguished ranking member came, so he missed his opening
statement.
Just kidding. Just kidding, Senator Harkin.
We have established a unique partnership, I think, that the
world knows about, to the detriment of both of us, personally.
But when we have changed gavels from time to time, it has been
seamless, and we have worked very, very closely together. And
I'm delighted to yield to my distinguished colleague today, who
has effectively tied up the Senate with an overtime issue on
which I agree with his position.
Senator Harkin.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. I wish it wouldn't tie up the Senate. I
wish we would just vote, that would be the end of it.
Thank you very much----
Senator Specter. We--Senator Frist may let you do that.
Then what are you going to do?
Senator Harkin. We vote, and then we move on.
Thank you very much, Mr. Chairman. And, again, I just echo
the words that you've said. I've enjoyed our partnership, now
going back 14 years, and the changing of the gavel back and
forth has been seamless. And I have appreciated your
willingness to work together and make this truly a bipartisan
subcommittee, in every sense of the word. The issues we deal
with, on health and education, medical research, biomedical
research, are not really partisan issues at all, and I don't
think either one of us have ever looked at them in that regard.
Mr. Secretary, it's always a pleasure to have you appear
before this subcommittee, and I look forward to working with
you in this year's budget process. First, I want to commend you
for your commitment to two important issues, issues that I know
are a top priority for both of us.
The first is the support for programs for persons with
disabilities. I appreciate your continued support for the New
Freedom Initiative and its goal of removing barriers to
community living for people with disabilities. This is
extremely important. Now let's work together to get the
legislation enacted.
Secretary Thompson. Please.
Senator Harkin. I also want to thank you for including
funding for the Real Choice System Change Grants in your fiscal
year 2005 budget. I don't think those funds would be there
without your personal intervention, and I appreciate that.
Second, I congratulate you on your efforts to make wellness
programs a priority. Obesity, lack of physical activity,
smoking, and poor nutrition are a grave threat to our country;
not just to individuals, but to all of us, as taxpayers. In
this country, we spend a trillion dollars a year on healthcare,
and the figures show that fully 75 percent of those are spent
on chronic diseases, like heart disease, cancer, and diabetes.
And what those diseases have in common is that often they're
preventable.
So, Mr. Secretary, I know you agree, because I've read your
statements. In this country, we fail to make the necessary up-
front investments in prevention. I'm absolutely convinced that
prevention is an idea whose time has come. And the good news
is, this can be and should be a bipartisan initiative. Senator
Specter and I are working together on some wellness initiatives
that we plan to include in this year's bill. I look forward to
working with you on these initiatives.
For one thing, CDC has promised to send me some more
pedometers. Ah-ha, you beat me to it. All right, Mr. Secretary,
tell you what I'll do. Unscripted, I tell you what, I may issue
a challenge, and I'll issue one to my partner here. We'll all
put pedometers on, and we'll see who takes the most steps this
year.
Secretary Thompson. Ten-thousand steps a day, Senator.
Senator Harkin. How many?
Secretary Thompson. Ten-thousand steps a day.
Senator Harkin. Are you doing that?
Secretary Thompson. Uh-huh.
Senator Harkin. I may take back my challenge.
Good for you. Well, that is a great example, because that's
what we've got to be doing here.
We're doing some other things. I've been working with
Senator Frist on getting some signs put by the elevators----
Secretary Thompson. Uh-huh.
Senator Harkin [continuing]. Which they've done at NIH. I
don't know if you've done your Department the same. If we just
go over there a little bit, there's a stairs. If you climb the
stairs, it's healthier, and there's a certain calorie type of
thing for how many stairs you climb, and stuff like that, to
get people climbing stairs. Well, that's just off the record.
But we're going to get the pedometers, and we're going to
try to get this thing moving here on the Hill. But, again, I
just wanted to commend you for those things. The Freedom Grants
Initiative, the money that you've requested for the Systems
Change Grants--please work with us to get that bill through,
the New Freedom Initiative. It's most important. And on all the
stuff you're doing on wellness and obesity and things like
that--I may differ with you slightly--I have this in my
questions--in terms of whether or not it should be mandatory or
permissive for restaurants and things like that, on the menus
and stuff, and we'll have a dialogue with you on the questions
on that.
The one last thing that--on a less positive note, I
suppose--I'm concerned about recent reports that the chief
actuary for the Medicare program was told not to tell Members
of Congress that his office had concluded that the Medicare
Prescription Drug Program--that would cost upwards of $10
billion more than previously reported. Again, I'll be asking
you this during the question-and-answer period.
Again, Mr. Secretary, I look forward to your testimony.
Secretary Thompson. Thank you very much.
Senator Specter. Thank you very much, Senator Harkin.
Senator Cochran.
OPENING STATEMENT OF SENATOR THAD COCHRAN
Senator Cochran. Mr. Chairman, thank you very much.
Mr. Secretary, we appreciate very much your exemplary
service as Secretary of the Department of Health and Human
Services. We also note that you've made strong efforts to begin
the implementation of the new Medicare Prescription Drug
Initiative. I'm pleased to see, also, the aggressive effort in
the budget to safeguard the country against bioterrorist
threats--$5 million that's included in the budget to help
prepare State and local governments to respond to these disease
outbreaks is an important step forward.
I also commend the efforts to identify threats before they
reach our country, and to prevent the entry of microbes,
diseases, adulterated drug products, and all other items that
would threaten the safety of our citizens. The budget also
provides funding to help improve the health of those who live
in small towns and rural communities, such as in my State of
Mississippi. Almost half of those served by small-town health
centers are in rural areas. The increase of $219 million to
provide for health centers and their sustainment was
appreciated very much.
It's my hope that special emphasis can also be placed on
targeting research to areas of the country that suffer
disproportionately from diseases like diabetes, cardiovascular
disease, and obesity. Generally speaking, I think, under the
pressures of trying to control spending and deal with the
problems of the deficit, this is a budget that should encourage
those of us who are interested in improving the health and
safety of American citizens.
Thank you very much.
Secretary Thompson. Thank you, Senator.
Senator Specter. Thank you, Senator Cochran.
Just one note, to answer the question which may be on the
minds of many, or at least some, about my Halloween mask. I
came out of the restaurant in Philadelphia on Saturday night
and tripped on a defect in the sidewalk, and landed squarely on
my nose. And I'm pleased to report that my nose was not broken,
but where my nose hit the sidewalk, the sidewalk was broken.
Mr. Secretary, the floor is yours.
Secretary Thompson. Mr. Chairman, Senator Harkin, Senator
Cochran, thank you very much.
I am very happy that the nose was not broken, and I'm glad
that you are mending back in good shape. That could have been a
very serious fall, and I'm very happy and appreciative that
things are----
Senator Specter. Mr. Secretary, my colleague in the
Philadelphia city race, Tom Gola, a famous basketball star,
lost his balance, slipped and hit his head, and he's been in
very serious condition ever since, so there are repeated
circumstances of people falling, and even fatalities, so I
consider myself very fortunate.
Having brought up the subject, I'm reminded there's a
famous story, probably apocryphal, about Winston Churchill
laying on a veranda one night, and a woman walked by and saw
his condition and said, ``You're drunk.'' And he responded,
``You're ugly.''
She recounted again, ``You're drunk.'' And he said,
``You're ugly.'' And then she said again, ``You're drunk.'' And
he said, ``Yes, but I'll be sober in the morning.''
Next week, I'll be back to my old appearance, however bad
that may be.
SUMMARY STATEMENT OF HON. TOMMY G. THOMPSON
Secretary Thompson. I want to thank you, Senator Specter,
for inviting me, and Senator Harkin, for giving me this
opportunity to discuss the President's fiscal year 2005 budget
for the Department of Health and Human Services.
In my first 3 years in the Department, I believe we have
made tremendous progress in improving the health, the safety,
and the independence of the American people. We continue to
advance in providing healthcare to seniors and to low-income
Americans, and in providing the welfare to children and
strengthening families and protecting the homeland. We have re-
energized the fight against AIDS at home and abroad. We've
increased access to quality healthcare, especially for
minorities, the uninsured, and the under-insured.
We're helping smokers--and I know this is a very big
concern of yours, Senator Harkin--free themselves of a
debilitating habit through a national hotline. We have set it
up in the Department, Senator Harkin, without asking the
Congress for any money. It'll be up and running by the end of
this year. And I want you to know that I pushed this, and I
feel as passionate as you do that we've got to reduce the
tobacco. And hopefully someday we'll be regulating it.
With your help, 3 months ago President Bush signed the most
comprehensive Medicare improvements since it was created,
nearly four decades ago. There has been some controversy, and I
know there'll be questions about it, and I'm going to answer
those questions completely to this particular Committee.
To expand on our achievements, the President proposes $580
billion for HHS for fiscal year 2005, an increase of $32
billion, or 6 percent, over fiscal year 2004. Our discretionary
budget authority is $67 billion, an increase of $819 million,
or 1.2 percent, over fiscal year 2004, and an increase of 26
percent since 2001. And I understand, Senator Specter, that
there are some gaps, and I want to work with you to see how we
might be able to ameliorate the situation.
Of this total, subcommittee is responsible for $63 billion,
an increase of $659 million, or 1.1 percent, over fiscal year
2004, or $974 million under current law. In order to strengthen
our bioterrorism preparedness and public-health system, we have
requested $4.1 billion, up from $300 million in 2001. And I
would respectfully--humbly respect--and invite all of you
Senators down to take a look at what we have done in the
Department. And I think you'll find it very impressive and
informative, what we have built, to be able to track diseases
and bioterrorism activities all over the world. I've had a lot
of people come down, and everybody that walks out of it feels
very much relieved that we are very much there. And I would
hope that you'd come down and see it.
This investment will improve our preparedness for
bioterrorism attack on any kind of bioterrorism attack or for
any public-health emergency. We already have seen our
investment pay off, in CDC's leadership in fighting the SARS
outbreak last year in a coordinated a public-health response to
the West Nile virus, and even helped to deal with a
particularly hard flu season this past year.
As you all know, I'm a very big proponent of information
technology. That's why we will be providing a computer
language, called SNOMED, to any proprietor that wants to, at no
charge, starting, hopefully, by the 1st of May. We're leading
the way in developing standards for electronic medical records.
And last month, I announced an FDA rule to prevent medication
errors by requiring bar codes on medicine and blood products.
Community health centers, as you have mentioned, Senator
Cochran, are absolutely a key element for increasing access to
and availability of healthcare for helping the uninsured. We're
proposing to provide $1.8 billion for health centers to provide
healthcare services to 15 million Americans. I want to thank
you, Senator Specter and Senator Harkin, for your leadership on
this. We wouldn't be here today if it wouldn't have been for
your great leadership.
Through our New Freedom Initiative, Senator Harkin, we're
working to help the elderly, the disabled, by promoting home
and community-based centers. In my desire to reduce obesity and
diabetes, we, along with the help of Congress last September,
my Department announced 12 steps to HealthierUS grants totally
more than $13 million to some more community initiatives to
promote better health and prevent disease. This included 23
communities, including one tribal organization, 15 small cities
and rural communities, and seven large cities. These
communities are doing some very exciting work in chronic
disease prevention and health promotion. For example, in
Washington State, health professionals are targeting Latino
adults who have diabetes, asthma, or obesity, or have a high
risk of getting those conditions.
In Michigan, through the Intertribal Council of Michigan,
public-health officials have created a resurgence of interest
in passing on traditional wisdom in cultural practices,
including consumption of highly nutritious traditional foods.
We're delighted by these activities, and the Department will
expand the program this year with the addition of $44 billion,
and has requested $125 million for these programs in 2005.
Later today, I'm going to unveil the Medicare improved
drug-discount cards. I will also announce that a Pennsylvania
company will be among our Medicare-approved drug-discount card
sponsors. This company serves 265,000 Pennsylvania seniors,
and, all together, Pennsylvania seniors will receive $486
million this year and next.
PREPARED STATEMENT
We look forward, ladies and gentlemen, to working with this
committee, the medical community, and all Americans as we build
upon our past accomplishments, implement the new Medicare law,
and carry out the initiatives that President Bush is proposing
to build a healthier, safer, and stronger America. And I want
to thank you for your bipartisan support on health issues.
Thank you, once again, for giving me this opportunity to
appear in front of you.
[The statement follows:]
Prepared Statement of Hon. Tommy G. Thompson
Good morning, Chairman Specter and members of the Subcommittee. I
am pleased to present to you the President's fiscal year 2005 budget
for the Department of Health and Human Services (HHS). I am confident
you will find our budget to be a positive solution to improving the
health, safety, and well-being of our Nation's citizens. Before I
discuss the fiscal year 2005 budget, I would like to thank the
Subcommittee for its hard work and dedication to the programs within
HHS. I am extremely proud of the manner in which we have worked
together effectively, in a bipartisan effort, since I was appointed
Secretary. This cooperation should be lauded and the tremendous results
for the American people can be seen in our many accomplishments.
This year's budget proposal builds upon past accomplishments in
meeting several of the health and social well-being goals established
at the beginning of the current Administration. I deeply appreciate the
level of support I have received from the Subcommittee during the past
on so many issues that have touched American's lives. For example, with
your help, the Department has funded 614 new and expanded health
centers. This has effectively increased access to health care for an
additional 3 million people, of which 64 percent are minorities,
increasing the overall number of patients served in health centers by
almost 30 percent. In the past three years, your support for protecting
our nation from bioterrorism has made the country better prepared and
better protected.
Your unwavering commitment in doubling the budget for the National
Institutes of Health has supported work by more than 217,000 research
personnel affiliated with 2,000 universities, hospitals, and other
research facilities across our great nation. This support has led to a
constant flow of new scientific discoveries. We have also established
the Access to Recovery State Vouchers program, providing 50,000
individuals with needed substance abuse treatment and recovery
services. HHS initiated a new Mentoring Children of Prisoners program
to provide one-to-one mentoring for approximately 30,000 children with
an incarcerated parent and created education and training vouchers for
foster care youth, securing funding to provide vouchers of up to $5,000
to 17,400 eligible youth since 2001. Last year, we worked together with
Congress to pass the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), adding prescription drug coverage for
seniors and modernizing the Medicare program. While I thank you for
your support in these and the many other accomplishments to improve the
health, safety, and well-being of our citizens, there is still much to
be done.
For fiscal year 2005, the President proposes an HHS budget of $580
billion in outlays to enable the Department to continue working with
our State and local government partners, as well as with the private
and volunteer sectors, to ensure the health, safety, and well-being of
our nation. This proposal is a $32 billion increase in outlays over the
comparable fiscal year 2004 budget, or an increase of about 6 percent.
The mandatory programs in the HHS budget total $513 billion in outlays.
Of this $513 billion, Medicare and Medicaid combine to equal about $474
billion, an increase of approximately $29 billion or 6.5 percent over
fiscal year 2004. The discretionary programs in the HHS budget totals
$67 billion in budget authority. Of this total, this Subcommittee is
responsible for approximately $63 billion in budget authority, an
increase of approximately $659 million, or 1.1 percent over fiscal year
2004 for proposed law, and an increase of approximately $974 million,
or 1.6 percent over fiscal year 2004 for current law.
For fiscal years 2004 and 2005, the MMA appropriated $1.0 billion
in start-up funds so that the Centers for Medicare and Medicaid
Services (CMS) would have funds available upon enactment to implement
the enormous increase in new administrative responsibilities under the
legislation. With rare exceptions, however, these administrative costs
have typically been categorized in the budget as discretionary. Thus,
this year the President's budget classifies the $1 billion for CMS
implementation of the MMA as discretionary.
In addition, the budget identifies approximately $500 million in
mandatory program savings for this Subcommittee's consideration. These
are four legislative proposals that I believe will lead to increased
cost effectiveness and reduced waste in the Medicare and Medicaid
programs. First, allowing beneficiaries to purchase durable medical
equipment after 13 months instead of 15 months is a lower burden for
our beneficiaries and a savings for Medicare, and it will improve
access to these products while reducing rental payments. Second,
requiring the Centers for Medicare and Medicaid Services (CMS) to use
the Administration for Children and Family's (ACF) wage database will
allow CMS to identify more quickly whether a beneficiary has employer-
sponsored insurance and to determine whether Medicare should be the
secondary payer, as opposed to the primary payer, to that other health
coverage.
Third, we are proposing to eliminate a windfall to the States by
reducing Federal reimbursement for Medicaid administrative costs by
about $300 million. Most states' TANF Block Grants were based on
expenditures that included the costs of determining Medicaid
eligibility, but they have also received Federal match for these
expenditures through Medicaid since TANF's implementation. Our proposal
seeks to eliminate this double payment for fiscal year 2005. Finally,
we are proposing to change the enhanced matching rates for
administrative activities toward systems' improvements, consistent with
other enhanced rates.
EXPANDING ACCESS TO HEALTH CARE FOR AMERICANS
One of the most important issues on which we can continue to work
together, is expanding access to quality health care for all Americans.
In 2002, the President launched an initiative to expand access to
health care by creating 1,200 new or expanded health care sites and
serving an additional 6 million people by 2006. Since the initiatives
inception, with the strong bi-partisan support of this Subcommittee,
the Health Centers program has significantly impacted more than 600
communities, serving over 13 million patients, 3 million more than in
2001, 40 percent of who have no health insurance coverage, and many
others for whom coverage is inadequate. In addition, States use Health
Insurance Flexibility and Accountability (HIFA) demonstrations to
expand health care coverage. As of January 2004, HIFA demonstrations
expanded coverage to 175,000 people and another 646,000 were made
eligible.
While we have made significant strides in this endeavor, there is
still much work to be done. In fiscal year 2005, the President's budget
request will continue to expand resources for Health Centers to a level
of $1.8 billion, an increase of $219 million over fiscal year 2004.
This increase will result in increased services for an additional 1.6
million people in approximately 330 new and expanded sites. This level
will provide access to comprehensive preventative and primary care
services, at over 3,800 health sites nationwide, for a total of almost
15 million uninsured and underserved individuals, nearly 7 million from
rural areas.
ACCESS TO RECOVERY
Mr. Chairman, the fiscal year 2005 budget represents the fourth
year of the President's strong commitment in leading our nation's
battle against addiction. With your support, we have made significant
progress. Current use of illicit drugs among students has declined by
11 percent between 2001 and 2003. However, there continues to be an
unmet need for drug treatment services. The fiscal year 2005 budget
will provide 100,000 individuals with drug and alcohol treatment
benefits by doubling funding to $200 million for the Access to Recovery
State Voucher Program. This program will allow individuals seeking
clinical treatment and recovery support services choices among
qualified community provider organizations, including those that are
faith-based. The program's emphasis is on objective results and is
measured by outcomes, including decreased or no substance use, no
involvement with the criminal justice system, attainment of employment
or enrollment in school, family and living conditions, and social
support.
DISEASE DETECTION AND BIOTERRORISM PREPAREDNESS
In the past three years, your support for our bioterrorism efforts
has been unwavering, and together we have made tremendous strides in
protecting our nation from various threats. While we have made great
strides, it is imperative that we remain steadfast in our commitment to
protect our nation and the well-being of all its citizens. The fiscal
year 2005 request for HHS bioterrorism activities is $4.1 billion, an
increase of $155 million above fiscal year 2004, and $3.8 billion above
the fiscal year 2001 level.
This work will be coordinated with the Global Disease Detection
Initiative at CDC. The Global Disease Detection Initiative (+$27.5
million) will help the United States learn more rapidly about new
disease threats that emerge in other Nations. CDC will recognize
infectious disease outbreaks abroad faster, and help those nations
identify and stop those diseases before they arrive in the United
States. In order to accomplish this task, CDC will expand its presence
internationally and collaborate with multinational organizations, such
as the World Health Organization (WHO) to improve overall global
disease detection, control, and surveillance. CDC will also invest an
additional $10 million to expand quarantine efforts at ports-of-entry
for international travelers.
Funds will be directed to carry out a new interagency bio-
surveillance initiative to prepare against a potential bio-terrorist
attack. The Centers for Disease Control and Prevention (CDC), in
coordination with the Food and Drug Administration (FDA), the
Department of Homeland Security, and the Department of Agriculture,
will be working to improve the response to bioterrorism through early
detection with the BioSense Surveillance Initiative. Through this
program, we will improve human health surveillance, strengthen the
laboratory response network, and increase the numbers of boarder health
and quarantine stations, which will allow us to identify and isolate
potential disease outbreaks more rapidly.
We also continue our work in building the Strategic National
Stockpile of drugs, vaccines and medical supplies that can be shipped
anywhere in the country on short notice, with a request for $400
million in fiscal year 2005. The fiscal year 2005 budget returns the
financing of the stockpile to HHS. DHS will continue to have the
authority to order deployment of the stockpile in an emergency, along
with HHS. The fiscal year 2005 budget includes a three-year financing
plan to expand our antibiotic stockpile to be able to provide post-
exposure anthrax treatment from 13 million to 60 million people. In
fiscal year 2005, we have included a contingency provision that will
allow us to transfer up to $70 million to the Stockpile from funds
available for State and local preparedness, should the added funds be
needed.
Our nation's ability to detect and counter bioterrorism ultimately
depends on the state of biomedical science, and the National Institutes
of Health (NIH) will continue to ensure full coordination of research
activities with other Federal agencies in this battle. The fiscal year
2005 budget includes $1.74 billion for NIH biodefense research efforts,
an increase of $120 million, or +7.4 percent. Included within this
biodefense total is $150 million to support the construction of
Biosafety laboratories for NIH to help develop medical protection from
bioterrorism, and to back up State and Federal public health
laboratories. Prior to fiscal year 2002, only a few laboratories in the
United States were capable of conducting research on potential bio-
terrorism agents. The $150 million investment in fiscal year 2005 will
fund an additional 20 Biosafety Level 3 laboratories across the
country.
The ability to mitigate the health effects of radiation exposure in
the potential event of the use of a limited nuclear or radiological
device in a terrorist attack presents a critical challenge for which
little progress has been made in the last forty years. For fiscal year
2005, $47 million is requested in the budget for the Public Health and
Social Services Emergency Fund, to be coordinated and managed by NIH.
This new initiative will support targeted research activities needed to
develop medical countermeasures to more rapidly and effectively treat
nuclear or radiological injuries.
Throughout my time as Secretary, many steps have been taken to
allow for improved access to vaccines for those in need and better
methods to combat the spread of influenza viruses. The average Medicare
reimbursement rate to physicians for the administration of the flu
vaccine increased from $3.98 per dose in CY 2002, to $7.72 in CY 2003,
an increase of +94 percent. The payment increased again in 2004 to
$8.25 per dose. In fiscal year 2004 and 2005, $40 million per year will
be used for creating a stockpile of children's influenza vaccine to
ensure this past year's shortages do not reoccur. While these previous
measures have improved access to vaccines, we must also look toward
future improvements. It is imperative that the United States develops
the domestic capacity to produce rapidly the vaccine our nation would
need in a pandemic. For that reason, the fiscal year 2005 budget seeks
to double to $100 million our investment to ensure a year round
production capacity for influenza vaccines to improve our preparedness
for an influenza pandemic, as well as develop production technologies
that could be scaled-up rapidly to provide surge capacity during a
pandemic.
CHILDHOOD VACCINES
The Budget includes two legislative proposals in Vaccines for
Children that I believe should be strongly supported by the members of
this Subcommittee. This legislation would enable any child who is
entitled to receive VFC vaccines to receive them at State and local
public health clinics. There are hundreds of thousands of children who
are entitled to VFC vaccines, but can receive them only at Community
Health Centers and other Federally Qualified Health Centers. The
proposal ensures VFC coverage of childhood vaccines for VFC eligible
children when they show up for services at a public health clinic.
Given the rising cost of childhood vaccines, ensuring access to VFC
vaccines for eligible children is especially important. Legislation is
also needed to restore tetanus and diphtheria vaccines to the VFC
program. The VFC authorization caps prices at such a low level that no
manufacturer will bid on a VFC contract. As a result, the vaccines that
are provided to VFC children through the public health system have to
be financed with scarce discretionary resources. Enactment of the
legislation the budget proposes would, at the same time, expand by $55
million the vaccines that are available to children while reducing by
$110 million the demand for vaccines financed with discretionary
appropriations.
CDC will continue to build a six-month, vendor-managed stockpile of
all routinely recommended childhood vaccines. Between fiscal year 2004
and fiscal year 2006, CDC will invest an additional $583 million to
meet target quantities needed for a six-month stockpile. Vaccines from
the stockpile can be distributed in the event of a disease outbreak and
will mitigate the effect of any potential manufacturing supply
disruption.
COMPLETION OF THE DOUBLING OF NIH
I commend you, Mr. Chairman, and this Subcommittee, for your
commitment in doubling the budget for the National Institutes of
Health, consistent with the President's request. Building on the
momentum generated by the fulfillment of the President's commitment to
complete the five-year doubling of the NIH budget, the fiscal year 2005
request provides $28.8 billion for NIH. This is an increase of $764
million, or +2.7 percent, over the fiscal year 2004 level. In fiscal
year 2005, over $24 billion of the funds requested for NIH will flow
out to the extramural community, which supports work by more than
217,000 research personnel affiliated with 2,000 university, hospital,
and other research facilities across our great nation. These funds will
support a record total of nearly 40,000 research project grants in
fiscal year 2005, including an estimated 10,393 new and competing
awards.
NIH remains the world's largest and most distinguished organization
dedicated to maintaining and improving health through the use of
medical science. Major advances in scientific knowledge, including the
sequencing of the human genome, are opening dramatic new opportunities
for biomedical research and providing the foundation for un-imagined
results in preventing, treating, and curing disease and disability.
Investment in biomedical research by NIH has driven these advances in
health care and the quality of life for all Americans, and the fiscal
year 2005 budget request seeks to capitalize on the resulting
opportunities to improve the health of the nation.
In an effort to target gaps and opportunities that no single NIH
institute could solve alone, the fiscal year 2005 budget allocates $237
million for the Roadmap for Medical Research initiative, an increase of
$109 million (or +85 percent) over fiscal year 2004. This initiative
consists of three core themes of establishing new pathways to
discovery, inventing the research teams of the future, and re-
engineering the clinical research enterprise.
COMMUNITY AND FAITH-BASED INITIATIVES
In support of the President's Community and Faith-Based Initiative,
the fiscal year 2005 budget maintains a commitment toward programs that
link community and faith-based organizations with State, local
governments, and Federal partners programs. The initiative creates
results by empowering those at the community level, who can best
identify the social and health related problems. Those at the community
level can then act to produce positive results and be agents of change
in the lives of the most needy.
The President's budget requests a total of $100 million for the
Compassion Capital Fund, doubling the fiscal year 2004 level. Initiated
in fiscal year 2002, the Compassion Capital Fund awards grants to
organizations which provide technical assistance to help faith-based
and community organizations access funding sources, operate and manage
their programs, develop and train staff, expand the reach of programs
into the community, and replicate promising programs.
As our nation's prison population continues to rise, another
important program that reaches our most vulnerable children is the
Mentoring Children of Prisoners program. Studies indicate that children
with incarcerated parents have a seven times greater chance of becoming
incarcerated themselves and are more likely to succumb to substance
abuse, gangs, early childbearing, and delinquency. This budget request
includes $50 million, maintaining the fiscal year 2004 level, to
provide grants to enable public and private organizations to establish
or expand projects that provide mentoring for children of incarcerated
parents and those recently released from prison. This activity will
give 30,000 adolescent children of prisoners a beacon of hope in their
world of despair.
The President's budget includes $10 million for Maternity Groups
Homes as part of the Transitional Living program. This will provide
pregnant and parenting youth who cannot live safely with their own
families access to adult-supervised community-based group homes, and a
range of coordinated services including childcare, job training, and
counseling.
HEAD START PROGRAM
One of the most fundamental truths in our society today is the
necessity for a solid educational background to allow all children the
opportunity to succeed. The initial educational experience is the
bedrock of our children's healthy growth and development. Mr. Chairman,
with the generous support of this Subcommittee, we have made a
significant difference in this beginning stage of our children's growth
and development. This commitment towards meeting the needs of our most
vulnerable citizens is unwavering and remains stronger than ever with
the 2005 President's budget request of $6.9 billion for Head Start.
This is an increase of $169 million over the fiscal year 2004 level. In
fiscal year 2005, 919,000 children will receive Head Start services
including 62,000 children in the Early Head Start program.
In fiscal year 2005, we will continue to emphasize the goals of the
President's Good Start, Grow Smart Initiative to strengthen Head Start
by partnering with States, by providing information on child
development and early learning to teachers, caregivers, parents, and
grandparents, and close the gap between research and practice in early
education. The fiscal year 2005 request includes $45 million to support
the President's initiative to improve Head Start by funding nine State
pilot projects coordinating State preschool programs, Federal child
care grants, and Head Start into a comprehensive system of early
childhood programs for low income children. The budget also includes
$124 million to maintain competitive salaries for Head Start teachers
and to support program enhancements in early literacy and cognitive
development.
PREVENTION INITIATIVES
More than 1.7 million Americans die of chronic diseases--such as
heart disease, cancer, and diabetes--each year, accounting for 79
percent of all U.S. deaths. Although chronic diseases are among the
most common and costly health problems, they are also among the most
preventable. The budget includes $915 million for CDC's Chronic Disease
Prevention and Health Promotion program, an increase of $62 million
over fiscal year 2004.
Within this request is $125 million, an increase of $81 million,
for the Steps To A Healthier U.S. Initiative. This increase will fund
the State and community grant program initiated this past September to
reduce the prevalence of diabetes, obesity, and asthma-related
complications, targeting those at high risk. Last year these funds
reached 23 communities, including seven large cities, one Tribal
consortium, and 15 smaller cities and rural areas, and more areas will
benefit during the upcoming year. Also a total of $10 million will be
used to expand the Diabetes Detection Initiative, which targets at-risk
populations. The aim of this initiative is to reach these populations
where they live, work, and play through a customized, tailored approach
with the aim of identifying undiagnosed diabetes.
The fiscal year 2005 budget request for the CDC National Breast and
Cervical Cancer Early Detection Program (NBCCEDP) is $220 million, an
increase of $10 million over fiscal year 2004. This program has helped
to increase mammography use by women aged 50 and older by 18 percent
since the program's inception in 1991. Efforts are targeted toward low-
income women with little or no health insurance and have helped to
reduce disparities in screening for women from racial and ethnic
minorities. With the requested increase, an additional 32,000
diagnostic and screening services will be provided to women who are
hard-to-reach and have never been screened for these cancers.
MENTAL HEALTH TREATMENT
In meeting the President's goal of transforming the mental health
system and increasing access to mental health services for some of our
most vulnerable citizens, the fiscal year 2005 budget includes $913
million in discretionary funding for mental health services, an
increase of $51 million over fiscal year 2004, or +6 percent. As an
important step in reshaping this delivery system, the budget proposes
$44 million for State Incentive Grants for Transformation. These new
grants will support the development of comprehensive State mental
health plans to reduce system fragmentation and increase services
available to people living with mental illness.
Recent studies have found that 20 percent of individuals
experiencing chronic homelessness also have a serious mental illness.
This request proposes $10 million for the Samaritan Initiative, an
Administration-wide initiative to reduce chronic homelessness, jointly
administered with the Departments of Housing and Urban Development and
Veterans Affairs. Through this initiative, States and localities will
develop processes to better enable access to the full range of services
that chronically homeless people need, including housing, outreach, and
support services such as mental health services, substance abuse
treatment, and primary health care.
FIGHTING HIV /AIDS
HIV is one of the most serious and destructive challenges facing
humanity in our world today. No country, whether large or small, rich
or poor, can escape the devastation it brings. All have citizens whose
lives have been destroyed by this horrible disease, and our commitment
to ending this pandemic is both strong and unwavering. No nation in
history has ever committed the time, energy, and fiscal resources that
the United States has invested in this effort. The fiscal year 2005
total HHS budget will continue this emphasis with the request for HIV/
AIDS funding of $15 billion, or +31 percent over fiscal year 2001 for
both domestic and global HIV/AIDS prevention, care, treatment, and
research activities.
Specifically, the fiscal year 2005 budget includes $784 million for
States to purchase medications for persons living with HIV/AIDS. At
this level, monthly AIDS Drug Assistance Programs will increase from
93,800 clients in fiscal year 2004 to 100,000 clients in fiscal year
2005. Also included is $53 million for the HIV/AIDS in Minority
Communities activities to support innovative approaches to HIV/AIDS
prevention and treatment in minority communities.
MARRIAGE AND HEALTHY FAMILY DEVELOPMENT
The President announced an expanded initiative to build on research
that there are life-long benefits of growing up in married-parent
families. This initiative, comprised of new and existing programs, has
four elements: (1) supporting marriage and families; (2) providing
tools to parents; (3) teaching values to children; and (4) encouraging
community and faith-based organizations to support families.
Within this initiative is $273 million to help parents and
communities provide teens with the tools to make responsible choices
and abstain from early sexual activity. The budget includes $50 million
to support a new program that will assist non-custodial fathers in
becoming more involved in their children's lives, and $107 million to
nearly double funding for State child abuse programs to reduce the
incidence of child abuse and neglect and increase services to those who
are victims.
HEALTH CARE INFORMATION TECHNOLOGY
Improvements in the safety, effectiveness, and efficiency of health
care, as well as in public health preparedness, can best be achieved by
the accelerated use of health information technology (IT). Therefore,
the fiscal year 2005 budget requests $50 million in new funding for a
Health Care IT initiative. This amount, by funding demonstrations and
investing in private sector and public program partnerships, will
accelerate the development and utilization of modern IT in both health
care and public health. These investments will assist development by
the private sector of needed standards, examine ways the use of IT can
be encouraged, coordinate actions across all agencies, and ensure that
this investment will further the national health information
infrastructure.
These resources will be made available to local, regional, tribal
and State data exchange networks and organizations, to provide the
infrastructure necessary for exchange of a patient's health information
within that area, and with other such organizations nationally. In
addition, technical assistance and resources to these networks and
information infrastructures will be available. These investments will
complement and build upon the Agency for Healthcare Research and
Quality's (AHRQ) demonstration grants and other activities to evaluate
the effects of IT on the safety and quality of health care--a critical
component of assuring that IT's positive benefits are adopted broadly.
MODERNIZATION AND REFORM INITIATIVES
With the enactment of Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, the Department faces many challenges in the
coming fiscal year. A top priority for CMS, and all Operating Divisions
within HHS, will be the timely implementation of the sweeping changes
in the law. As the most significant reform of Medicare since its
inception in 1965, the law expands health choices for beneficiaries and
adds a prescription drug benefit. MMA will strengthen and improve
Medicare, while providing beneficiaries with new benefits and the
option of retaining their traditional coverage.
Along with Medicare reform, the President remains fully committed
to strengthening and empowering America's families through legislation
supporting welfare reform, modernization of Medicaid and SCHIP,
increased child support enforcement, and reform of the child welfare
system.
MANAGEMENT IMPROVEMENTS
Finally, I would like to update the subcommittee on the
Department's efforts to use our resources and the taxpayer's dollars in
the most efficient manner. To this end, HHS remains committed to
setting measurable performance goals for all HHS programs and holding
managers accountable for achieving results. I am pleased to report that
HHS is making steady progress. We have made significant strides in
streamlining and making performance reporting more relevant to both
decision makers and customers. As a result, the Department is better
able to use performance results to manage and to improve programs. By
raising our standards of success, we will continue to improve
efficiency and increase our ability to improve the health of every
American citizen.
IMPROVING THE HEALTH, SAFETY, AND WELL-BEING OF OUR NATION
Chairman Specter and members of the Subcommittee, I would like to
thank you once again for your passion and support in working with us in
this fight to improve the health, safety, and well-being of all
Americans. The budget I bring before you contains proposals from many
different areas. These programs, from enhancing the building blocks for
our youngest and most vulnerable with Head Start, to expanding Health
Centers to increase the access to quality health care for minorities,
to protecting our nation from the threat of bio-terrorism, all meet
vital needs within our communities. All of these proposals, which vary
greatly in substance, are put forth with one simple overarching goal of
ensuring the health, safety, and well-being of all Americans. I know
that this goal is one that we share together, and I look forward to
your continued support as we move toward turning our passionate
commitment into positive results for the American people.
Senator Specter. Thank you very much, Mr. Secretary.
We will now proceed with our customary 5-minute rounds.
PRESCRIPTION DRUG BENEFIT ESTIMATES
Mr. Secretary, the morning news reports are filled with the
testimony of Mr. Richard Foster before a House committee
yesterday, where he, in his capacity as the Medicare programs
chief actuary, told House Members that he gave an analysis last
June to the White House and the President's Budget Office which
was not shared with the Congress, predicting that prescription
drug benefits being drafted on Capitol Hill would cost about
$150 billion more than President Bush said he wanted to spend.
And he further reported that unnamed administration officials,
or perhaps they are named, threatened to fire him.
I have two questions for you on that. Do you have any
personal knowledge that the cost estimate of $150 billion was
concealed? And, second, do you have any personal knowledge
about the alleged threats?
Secretary Thompson. Senator, let me quickly respond, as
accurately as I possibly can. Number one, I read in the paper,
after the alleged threat by the Administrator of CMS--I had my
chief of staff immediately----
Senator Specter. The first you knew about it was reading
about it in the newspaper?
Secretary Thompson. No, no. This was way back in June when
this took place. I read about it in the newspaper, I heard
about it, and I had my chief of staff call----
Senator Specter. And my question is: The first time it came
to your attention was when you heard news reports?
Secretary Thompson. That is correct. Last June.
Senator Specter. Okay.
Secretary Thompson. And then I had my chief of staff
contact Mr. Foster and tell him, directly from me, that his job
was not in jeopardy.
Now, the actuary's assumptions, based upon that, was only
for the first section of Senate bill 1, and that was $550
billion. I did not know of that figure. I did know of the
assumptions that Rick Foster had projected that we would be
having more people participate in Medicare, by 94 percent
versus CBO's number of 87 percent that was publicized. The
Congress knew about that. The administration knew about that.
And that was the big difference.
The second difference on the cost estimates was based upon
how much is going to be used by low-income seniors. We assumed
that it's going to be a lot more than CBO. CBO scores it at 87
percent. We score it at 94 percent. That is a difference of
about a $100 billion of the $134 billion difference between CBO
and our actuary. That's based upon assumptions. Those figures
were known--not the exact figures. The fact is, is that we knew
that they were going to be more, and we made that to be known
to the Congress.
Senator Specter. Well, focus specifically on what Mr.
Foster----
Secretary Thompson. Okay.
Senator Specter [continuing]. Has said. And that is that he
had a figure of $154 billion more than the President's figure,
and he did not tell Congress about that $150 billion more.
Secretary Thompson. Senator, that was based upon an earlier
bill. That was Senate bill 1 that was introduced--that was the
chairman's score from the Finance Committee. That was not the
bill that was debated on the floor of the Senate or the House
of Representatives. Those figures didn't come out until
December of this past year, after the bill passed.
Senator Specter. So are you saying that his allegation is
factually incorrect, that he did not have information about
$150 billion excess beyond what the President wanted to spend,
and that he did not conceal that from the Congress?
Secretary Thompson. I'm saying that the $150 billion
difference is based upon an earlier version of the bill, and
the final version is $134 billion, and that didn't come out
until December 13. And the $150 billion was based upon only the
first section of the bill. And there was no--to the best of our
knowledge, and we have looked through all the records--there
has not been any written record where any Member of Congress
has asked for the earlier assumptions or the earlier figures.
And that's why I've asked the inspector general of my
Department to get all the facts so that we can report it to
Congress. I have asked the inspector--have asked the Inspector
General to make a detailed report to me and to Congress.
Senator Specter. My red light just went on, and I want to
observe the time limits, so I'll turn now to Senator Harkin.
Senator Harkin. Mr. Secretary, I think the record will show
here that you might have made a little bit of a misstatement,
because I made a note on this. You said you read about this
last June in the news reports. You did not read about it last
June.
Secretary Thompson. Yes, I did.
Senator Harkin. There was a news report last June----
Secretary Thompson. Yes, there was.
Senator Harkin [continuing]. In the newspapers----
Secretary Thompson. Absolutely.
Senator Harkin [continuing]. Saying that there was this
higher estimate?
Secretary Thompson. No. No, there was a--the newspaper
article that was last June was--is that--it came out, it was
reported by AP, that Mr. Foster had been threatened that he was
going to lose his job if he didn't send up--and what was
requested was the score on the benefits of the particular bill,
on premium support.
Senator Harkin. Premium support, that's----
Secretary Thompson. Premium support. And that was what was
requested. That was what Tom Scully had told Rick Foster not to
send up. That's what was said.
Senator Harkin. Okay.
Secretary Thompson. Then Tom Scully says, ``Somebody made
the allegation that you're going to get fired if you send it
up.'' When I heard that, I asked my chief of staff to call--
which he did--call Mr. Foster and say, ``Your job is not in
jeopardy at all.'' Mr. Foster has testified to that.
Senator Harkin. Okay, then, I still wonder why we were not
given those numbers.
Secretary Thompson. We've looked at it, Senator Harkin, and
we do not believe there has ever been a written request from
any Member of Congress--neither the Senate or the House had
ever requested for those figures. Those figures were
preliminary figures on Senator Grassley's bill, and it was only
on the benefit portion, on the drug portion, not the total
bill. And that figure was $551 billion. And the last figure
that deals with the bill that was passed was $534 billion.
Senator Harkin. Uh-huh.
Secretary Thompson. That's $17 billion difference, and
that's--and Rick Foster testified yesterday that the final
figures did not come out until the latter part of December,
after the bill passed.
Senator Harkin. That's right. But on June 3, Foster made
his higher estimate. That's one. That was $150 billion.
Secretary Thompson. That is--but that was on a different
bill. That was on----
Senator Harkin. That was on S. 1.
Secretary Thompson [continuing]. S. 1. But that was--that
was the chairman's mark, and that was only on the drug benefit.
It wasn't on the other seven provisions of the bill, the other
seven chapters.
Senator Harkin. Okay. So then the bill passed in November,
but the bill that passed--it was somewhat different than S. 1,
obviously.
Secretary Thompson. Completely different.
Senator Harkin. Well, I don't know that it was completely
different; it was somewhat different. But are you saying that
it made no difference whether or not we knew there was $150
billion more, or what the estimates were by the time the bill
passed?
I guess it just seems to me that, you know, who knew what,
when, and how they knew it, and all that kind of stuff. It just
seems to me that we have a fundamental question here. Do you
think it should be the policy of the administration, any
administration, that the actuaries officers at CMS provide
technical assistance to Members of Congress, as I understand
the practice was before this year? Now, I could be mistaken on
that. But I understand the practice was that the actuaries
office at CMS provided information to the relevant committees.
Secretary Thompson. We have looked at that, and that was
not the practice, and that's why there was some report language
put in, in the Balanced Budget Act, because members of the
Republicans were not able to get it from the actuary under the
previous administration.
But to answer your question, Senator Harkin, I think that
that information should be made available, and I have testified
to that previously.
Senator Harkin. I agree with you, because obviously it was
collected at taxpayers' expense. I mean----
Secretary Thompson. Yes, sir.
Senator Harkin [continuing]. This is not some private
entity doing this, and that--those figures ought to be
available for policymakers. I don't know what the end result is
going to be, but I hope it is that we have access to these kind
of figures in the future, I hope.
Secretary Thompson. I think you should. I think you will.
The CBO numbers are the ones that are--and those are the ones--
the CBO still says it's $395 billion, not the $534 billion. And
there's a logical explanation that I could go into if you would
want me to, Senator Harkin.
Senator Harkin. My time is up. I hope we get a second
round, because I did want to ask you about the Wellness
Program.
Senator Specter. There will be a second round, Senator.
Senator Harkin. Thank you, Mr. Chairman.
Senator Specter. Senator Cochran.
DRUG REIMPORTATION
Senator Cochran. Mr. Secretary, we've had some debates and
votes on amendments here in the Senate relating to importation
of pharmaceutical products from other countries. Are there
sufficient funds in this budget request to deal with the
problem of counterfeit or unsafe pharmaceutical products that
may enter the United States from other countries?
Secretary Thompson. I don't think so, Senator. I think it's
a growing problem, and I think that we are doing the best job
possible. As you know, I requested this Congress, early on when
I came on, to get enough inspectors to deal with some things
with food. We have increased it. But, overall, I still think
that there is a good chance of having counterfeit drugs. And we
see that every time we stop. We had, as you know, some
inspections at the border not too long ago, one in July and one
in September and October of this year, and about 87 percent of
the drugs that came in were either mislabeled, mis-packaged--
some were counterfeit, some were not certified by FDA, or
approved by FDA. So a lot of drugs that come into America are
not regulated by the FDA.
Senator Cochran. Are you making an effort to bring this to
the attention of our friends around the world, and try to get
help there in those countries?
Secretary Thompson. We are. We have a very strong,
aggressive outreach program to other countries, especially to
Canada. But Canada has pretty much indicated that it's not
their problem, and it's our problem, and that we should address
it ourselves. We have started hearings. Last Friday was the
first hearing. I set up a commission, headed up by Surgeon
General Carmona, to take a look at reimportation, importation,
as well as ways in which we can develop it.
We've also set up a task force on counterfeit drugs, and we
announced that a couple of weeks ago. We're working with the
Federal Trade Commission and the Department of Justice in
regards to that.
We're quite aggressive, but your question was, are there
enough resources? I don't think there are, because FDA is very
strapped with all of its demands. And this is a huge problem,
and if, in fact, we are going to have reimportation, we're
going to have more resources in order to make sure that this
reimportation of drugs are safe.
VACCINES
Senator Cochran. In connection with the availability of
vaccines to deal with threats to the public health----
Secretary Thompson. Yes.
Senator Cochran [continuing]. There seems to be a gap
between what we should have and what we do have in the way of
an inventory of vaccines, being able to locate them, and then
mobilize our resources to deliver them where they may be needed
in case of an outbreak of a disease or illness. Is there any
effort in the budget to deal with that problem by providing
funding to the Centers for Disease Control or other agencies
that could help move us in the direction to deal with that more
effectively?
Secretary Thompson. Absolutely, there is, and you've
already done a great deal, and I wish you could just come down
and see how we track this. We have got the country split up
into 12--in 10 regions, but we have 12 strategic locations
where we have 600 tons of medical supplies, antibiotics,
vaccines that we can strategically deploy to any city in
America within 7 hours. It takes nine semi-truck loads or a KC-
135 in order to do so. And we track that.
We also have got, at the present time, enough smallpox
vaccine, 400 million doses, to vaccinate every man, woman, and
child in America. We have enough doxycycline and Cipro, as far
as anthrax is concerned, to treat 14 million people in America
for 60 days. We have money in here to go to 20 million, which
is a huge increase of supplies that we're going to have to put
in the supplies depots, but we're going to do that.
We are asking for a BioShield, which is still tied up in
Congress, and this is going to allow us to reach out to the
pharmaceutical and biological companies to develop new vaccines
for tularemia, for the plague, and for hemorrhagic
superviruses, and so on.
We're doing a lot, but we can always do more. I'm very
satisfied with where we are, but I know that we can improve,
and that's what we intend to do.
Senator Cochran. Thank you very much for your efforts in
this area. It's so important to homeland security and the
health and safety of our American citizens.
Secretary Thompson. I would hope you'd come down and see
us, Senator.
Senator Cochran. I'll do that. I need to go to the Center
for Disease Control, too. I've never gone down there to take a
tour around. I've seen photographs of some of the buildings
that need upgrading----
Secretary Thompson. Senator Specter's been down there. I'd
like you to come down there. It's worth your time to do it.
We're only a block away. If you come down, I can get you
through in a half an hour, 45 minutes, and I can show you
exactly how we track diseases and storms and whatever we've got
to face. It's really an educational type of thing, and it's
really--I invite you. I'd love to have you come down and host
you and get a chance to see it.
Senator Cochran. I accept your invitation, with pleasure.
Secretary Thompson. Thank you.
ORASURE
Senator Specter. Mr. Secretary, a Pennsylvania company,
Orasure Technologies, Incorporated, in Bethlehem, has developed
a 20-minute HIV test, and I know you're familiar with it.
Secretary Thompson. I'm very excited about it, Senator.
Senator Specter. On March 10, Orasure met with HHS
officials regarding additional purchases through the Substance
Abuse and Mental Health Administration, and was led to believe
that SAMHSA had committed to a $13 million purchase order;
however, SAMHSA has now told staff that no such commitment has
been made, and any potential purchase will be less than $5
million. You and I have exchanged correspondence on it. I would
be interested to know whether there was any commitment for a
$13 million purchase, and what you anticipate by way of a
purchase in light of the remarkable technology at hand and the
tremendous need for determining, in Africa and other places,
whether the people have HIV/AIDS?
Secretary Thompson. I can't answer you specifically as to
what was committed by SAMHSA, or if there was a
misunderstanding, but I will get an answer to you very quickly.
I'm sorry about that, that I don't have it at the top of my
head, Senator Specter.
[The information follows:]
Orasure
We are committed to using new technology to identify undiagnosed
HIV-positive individuals, help them reduce risk of transmission, and
refer them to care. In fiscal year 2003 CDC bulk-purchased $2 million
of rapid tests (250,000 kits), and has placed an additional $2 million
order for fiscal year 2004. We have also encouraged our international
partners to consider the OraQuick tests in their efforts to identify
individuals with HIV/AIDS. The Global Assistance Program countries
frequently use OraQuick as a tie breaker when two less expensive tests
give different results.
SAMHSA submitted a request to the HIV/AIDS in Minority Communities
Fund to purchase HIV rapid test kits for its HIV/AIDS grantees. At this
time, no final decision has been made about the level of funding
available for this request. The HIV/AIDS in Minority Communities Fund
supports innovative approaches to HIV/AIDS prevention and treatment in
communities of color. Each year HHS agencies/offices submit proposals
for activities to reduce the disproportionate impact of HIV/AIDS on
racial and ethnic minorities. In fiscal year 2003, a total of eight
agencies/offices received dollars from this fund. It is our hope to
reach final decisions on these dollars very shortly.
GLOBAL FUNDS FOR AIDS, MALARIA, AND TUBERCULOSIS
Secretary Thompson. In regards to Africa, as you know, I'm
chairman of the Global Fund for fighting AIDS, malaria, and
tuberculosis. I advised--we just came back from Geneva this
past--we had our seventh board meeting, and I advised the board
of this new, innovative idea that Orasure has come up with. The
problem we have in the Global Fund is that it will use Orasure
to be the arbitrator. They don't use it for the basics. I mean,
they have a cheaper product. And if there's some question as to
the accuracy, then they bring in Orasure to determine for sure.
When they came out with this new quick test, I'm hoping to be
able to push through the Global Fund to be able to be a bigger
user of Orasure's product, because I'm very sold on it, and I'm
very--I think the company is doing a tremendous job, and I
think it could help save us money in the future.
Senator Specter. Well, thank you for that answer and for
your assurances that you will take a look to see what
commitments----
Secretary Thompson. I will.
Senator Specter [continuing]. Have been made by SAMHSA or
others in your Department.
CDC AND NIH BUDGETS
A two-part question, Mr. Secretary. Your budget document
states there is a growing concern that the next public-health
emergency could overwhelm current capacities to respond, and
would likely overwhelm CDC's current capabilities. How can we
realistically cut the CDC budget by $116 million on their
overall budget, and almost 180 million on their buildings and
facilities, in the light of their mission and the tremendous
threats?
The second question I have for you relates to the budget of
the National Institutes of Health, where we are facing a
situation with the administration request to lead to a drastic
curtailment of NIH awards.
If you would respond to those two questions, I would
appreciate it.
Secretary Thompson. Thank you. And let me quickly respond
so I can get to both of them.
In regards to CDC, let me say that I let you down, Senator.
I did not sell as effective as I thought I should have been
able to, to get a little more money into buildings. That is the
big difference in the reduction at CDC. As you all know, and
you've been the leader in this, we're trying to get $250
million a year down there, and we came in with a budget of $82
million, of which $40-some million is going to Fort Collins.
That is the big difference. A reduction in the VERB program was
the other. I gave Director Gerberding, Assistant Secretary
Julie Gerberding, an allotment of what she could do. She came
in with the best budget she could. I think it's quite good.
In regards to overwhelming the resources, the biggest thing
I'm concerned about right now is a pandemic flu, and we have
put some additional money in there, $50 million in the CDC,
I've got $50 million into my accounts, in order to try and make
sure that we are prepared to try and move companies from the
egg culture to the cell culture, especially with avian flu that
may come or may not come. I am very concerned about that. And
avian flu could have the potential for destroying some of the
egg stock because it affects chickens, and so we're trying to
do something.
In regards to NIH, we still, under our budget, are going to
be able to give out more grants. Where we saved the dollars was
reducing what was called the cost of increase to the cost of
inflation over the 4-year grants, and we reduced that
approximately from about 3.3 percent down to about 1.3 percent.
But next year, even if our budget--if Congress doesn't put more
money into it, there will be more grants out there than there
has been before. And since I've been Secretary, thanks to you,
the Congress leadership in giving us the dollars, we have gone
up by 30 percent in grant applications, in grant requests, in
grant approvals, and 42 percent increase in the amount of
dollars that those grants have been able to receive.
Senator Specter. My red light went on in the middle of your
answer, Mr. Secretary. And we will be submitting more detailed
questions on NIH----
Secretary Thompson. Thank you.
Senator Specter [continuing]. For the record.
Secretary Thompson. I would be more than happy to answer
them, sir.
Senator Specter. We've been joined by the distinguished
chairman of the full committee.
Senator Stevens.
HEALTHCARE DELIVERY
Senator Stevens. Thank you, Mr. Chairman. I do have three
other areas to stop by--I stopped by here, Mr. Chairman,
because I don't think any person in history has brought more
hope to the Alaska native people in the area of healthcare
delivery than Secretary Thompson, and I'm----
Secretary Thompson. Thank you.
Senator Stevens [continuing]. Here to thank you very much
and, what's more, to invite you back again. Your annual visits
really bring great hope to our people.
ALASKA DENTAL ASSOCIATION
You may be interested to know that yesterday, for the first
time, the American Dental Association, the Alaska Dental
Association, approached me with the idea of trying to interface
some dental care into the village health clinics. That has been
a total gap, in terms of the care----
Secretary Thompson. Huge gap.
Senator Stevens [continuing]. Of Alaska natives. It's
really great news. They came forward on their own, and I look
forward to working with you and with your people on trying to
partnership with them. They're willing to take on part of the
cost. It's a very interesting thing.
POSITRON EMISSION TOMOGRAPHY
I also am grateful to you for what you've done to help us
try to move CMS forward to bring about the favorable coverage
decision for PET, positron emission tomography. I do believe,
Mr. Chairman, that there's no system that holds more hope for
dealing with the baby-boom generation than PET, in terms of
trying to get a handle on Alzheimer's and those diseases
related to dementia. And, clearly, if we follow through in that
generation with the amount of Alzheimer's we've had in my
generation, the cost is going to be overwhelming. We must find
some way to deal with it, and at least PET will give us a
chance for our medical researchers going ahead to try and find
a cure to slow it down and to provide the opportunity, through
the prescription drugs already on the scene, to deal with
severe symptoms and to give those seniors with Alzheimer's a
chance to have a fairly decent life as they can--into that
terminal period. I can't thank you enough for that.
I do have a couple of questions that I would like to submit
for the record, if I may, Mr. Chairman. And I thank you for
your courtesy.
OBESITY
My last comment would be, keep up the battle against
obesity.
Secretary Thompson. Thank you.
Senator Stevens. You know, we're just back on a journey
through the Middle East, Mr. Secretary--Jordan, Iraq, Kuwait,
Pakistan, Afghanistan, and even into France. We're the only
nation that really has this terrible, terrible addiction to
obesity, that I saw on that whole trip. Not our military men
and women, thank God. They get the discipline when they're
fairly young, and I hope it carries through for them. But for
our community at large, I think obesity is becoming a number-
one challenge to our survival. So I would hope we would all
join with him and help him as much as possible.
Thank you for your courtesy.
Secretary Thompson. Thank you very much, Senator Stevens,
and let me just thank you for your leadership. And, yes, I will
be back in Alaska. I told you I'd go back to Alaska every year
as long as I'm Secretary, and we've made some progress; not as
much as you or I would like, but we're making some, and we'll
be back there, and we've still got to work on the water and
sewer for Alaska natives, because that is still--it's a huge
problem, and I know you're the leader in that that, and I
applaud you.
PREPARED STATEMENT
Senator Stevens. Well, when your nearest neighbor is 500
miles away in every direction, and you have a hundred people,
hope is a great thing.
Secretary Thompson. Yes, sir.
Senator Stevens. And you've brought hope to those people,
and I want to help you continue that.
Secretary Thompson. Thank you very much.
Senator Stevens. Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Ted Stevens
Thank you Mr. Chairman. Secretary Thompson, it's a pleasure to see
you here today. Once again I want to express my appreciation for your
leadership on a host of issues that are of vital importance to all
Americans. I especially want to thank you for all that you have done
for Alaska. We are looking forward to having you visit us again this
summer.
I am also very grateful to you for helping get C.M.S. moving
forward to a favorable coverage decision for PET scans to help diagnose
Alzheimer's disease in Medicare patients at an earlier time than any
other diagnostic test. That coverage will give many seniors who
discover they have Alzheimer's a chance to slow the progress of the
disease with medication before its incapacitating symptoms appear.
Mr. Secretary, I believe we will be facing a crisis of huge
proportions when Alzheimer's begins to strike the baby boom generation.
I hope our investment in medical research at NIH will produce a cure
before that time. But, in the meantime, early diagnosis of Alzheimer's
disease, through pet, coupled with currently available prescription
drugs begun at a stage before the most severe symptoms appear, will
help many seniors continue to lead productive and reasonably healthy
lives.
I'm also pleased that you were finally successful in including
funding in your fiscal year 2005 budget for the Denali Commission.
While it is less than our fiscal year 2004 number, I know that you have
worked hard to have those funds included in your budget because you
have seen first hand many of the infrastructure projects the commission
has funded in remote parts of Alaska.
I am concerned that several programs that fund rural health
activities, like the Rural Outreach grants and Rural Hospital
Flexibility grants have been eliminated. Both of these programs, while
relatively small ones, have benefited remote communities in Alaska and
other rural States that need special help to provide needed health
services. I know this is a very tight budget, but I urge you to work
with the subcommittee to restore funding for these programs.
Another matter of concern to me is our Nation's growing epidemic of
obesity. Mr. Secretary, you are to be applauded for your personal
leadership in this area, beginning with your putting the Department on
a diet and encouraging physical activity. I hope you will continue to
push forward, because yours is a message we must heed. A recent report
from the CDC tells us that obesity will soon overtake smoking as the
Nation's leading cause of preventable death. I will be pleased to work
together with you in your efforts to make us a healthier Nation.
Mr. Secretary, again I thank you for your tireless efforts to
improve the health and well being of Alaskans and other Americans.
Senator Specter. Thank you, Senator Stevens.
Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
MONEY FOLLOWS THE PERSON INITIATIVE
Mr. Secretary, as I said in my opening statement, I know
you've long supported the right of people with disabilities to
choose to live in their neighborhoods and communities, rather
than nursing homes and institutions. Along with Senators
Specter and Smith, we introduced a bill last summer to get the
Money Follows the Person Initiative, as it's called, enacted
last summer. As I said earlier, you included funds for this
initiative in your fiscal year 2005 budget, for which we're
very appreciative. I understand the Finance Committee is going
to hold hearings on this issue on April 7. Again, these are all
good first steps, but we really need your support to get this
bill moving through Congress and signed into law.
I haven't really heard of any real opposition to it. It's
just, sort of, we've got to get it moving. You know, we hear a
lot of talk about the New Freedom Initiative and everything,
and we're all very supportive, but nothing seems to happen. I
guess I'm just asking if you could really help with the
administration and getting this thing moving through Congress
this year. That's all I'm asking.
Secretary Thompson. Absolutely. I am as passionate about
it, hopefully, as you are, Senator. And I want to see it done,
because I'm not going to be here next year, and I want to make
sure that we get it through before I leave, and then I'm--I
have talked to Senator Grassley on it, and he's going to hold a
hearing on it. I'm hoping he'll get the bill introduced quickly
so we can start getting co-authors on it and start getting
bipartisan support. I don't think there's that much--any
opposition to it. I think we've just got to get the time to get
it through the committee and on the floor and through both
houses. And I know the President's going to sign it. So let's
work together on a bipartisan basis and make sure it gets
completed this year.
Senator Harkin. Well, I appreciate that, and I just--
whatever we can do to help, but you can also be very
influential in----
Secretary Thompson. Thank you.
Senator Harkin [continuing]. Move it through. And I know
you're passionate about it. And I agree with you, we've got to
get it through this year.
FOOD LABELING
The second part of my question is, I had--I said I'm--
again, I'm really appreciative of all that you're doing
personally, and, through you, your Department, on this issue of
obesity and wellness, and personal wellness as, sort of, a
thing that we've got to be focusing on. I am somewhat puzzled,
however, by the fact that many of the recommendations
pertaining to the food industry and the labeling of foods,
especially restaurant foods, are voluntary rather than
mandatory.
As the FDA report notes, food consumed away from the home
has increased from 33 percent of consumers' food budgets in
1970 to 47 percent in 2002. Over the same period, total
calories consumed from food purchased outside the home
increased from 18 percent to 32 percent. I guess my question is
this: Why, then, despite FDA's own assertion that the food
labeling required under the original National Labeling
Education Act has been helpful to the consumers, and despite
the fact that your focus groups show that consumers would like
more labeling in restaurants, why do does the report recommend,
quote, ``urge'' the restaurant industry to launch a nationwide,
quote, ``voluntary'' and point-of-sale information campaign for
customers, rather than some sort of mandatory labeling
requirement? I guess that's the essence of my question. Why
voluntary? Why not have some mandatory labeling requirement for
that information?
Secretary Thompson. It's a different way to approach the
problem. I'm not saying one approach is that much better over
the other one. Every month I sit down with a different group of
people. I've met with the Restaurant Association now three
times. I have asked them to put more information on their
menus. Most of them are complying. It was a tough sell in the
first meeting. Every meeting since then has been getting
better, Senator. And the last one was a very friendly meeting
in which they were volunteering many more menu items that are
going to be heart-healthy and low carbs and better, and they're
going to be more informative.
Number two, I have met with the health insurance companies
many times. I met the health insurance, health companies,
medical companies, and so on. I do this on a monthly basis. I
bring in a different group to talk about prevention. And we
continue to do that. We're holding a summit, I believe, next
week, in Baltimore, on prevention, and we're having, I believe,
1,200 people that have signed up already to do it. So I'm using
the bully pulpit because I believe, like you do, of $1.5
trillion, 75 percent is for chronic illnesses--$155 billion for
tobacco-related diseases, 442,000 people die; $135 billion for
diabetes, 200 million Americans die; $117 billion on obesity.
And I think we can do a lot better job. And I just think right
now we can do it by pushing rather than hammering them.
Senator Harkin. Well, Mr. Secretary, I was here when we
pushed through the labeling for packaged goods in grocery
stores. We had the same arguments then from the grocery people.
The grocery manufacturers--oh, my gosh--``We changed the
contents of boxes. We can't be doing this. And it's just going
to be awful. It's just going to cost so much money.'' We went
ahead and did it, and, you know, not even a blip. And yet
people rely on that today. They go to grocery stores--it's
taken some years, but now you look, I think the figures are
over 60-some percent in surveys--people go to grocery stores,
look at those labels to find out what they're buying.
Now, Ruby Tuesday, I don't know anybody--I don't know Ruby
Tuesday--who owns it or who runs it, but I have a feeling they
had a lot to do with these people now being more willing to put
things on their menus, because Ruby Tuesday voluntarily said
they're going to put it all in.
Let me just show--where's my chart? They were saying how
onerous it was going to be. Here's a typical menu. And all they
did is, they put the calories, the saturated fat, and sodium
for each item. It's not a big deal.
Secretary Thompson. It is not.
Senator Harkin. It's not a big deal.
Secretary Thompson. And it's very enlightening. And that's
what we've got. We're changing the labeling out at FDA. We set
up a committee. We're going to have some new labels with more
information as to calories, portion size. And that's coming to
FDA.
Senator Harkin. But, again--and I know my time is up--I'm
all for volunteerism, but FDA is also in the business of
regulation and mandating, and we've been through this before,
because it is such a health crisis. I, again, urge you to get
the FDA involved in setting down a mandatory--there's
legislation here, as you know, to do that, pending in the
Senate and the House, to get the FDA to set down regulations on
information of fat, calories, sodium on menus in restaurants.
Rather than urging them--and you can urge and urge and urge.
Some will do it, but not all of them will.
Secretary Thompson. I think you're going to see a lot of
that kind of information on the labels when we come out later
on this summer, Senator.
Senator Harkin. Well, I hope so.
Secretary Thompson. I think you'll be very happy with it.
Senator Harkin. But, again, I guess my rhetorical response
might be, well, should we undo the regulations on the labeling
regarding packaged good, and just make that voluntary?
Secretary Thompson. No.
Senator Harkin. Of course not. Of course not. So I think
this is, sort of, the next step in that, and I still believe
that--I hope voluntarily everybody does it, but then you're
going to have--maybe one will voluntarily put this information,
someone will put this information.
Secretary Thompson. No, we're going to have uniform
standards, and I'm going to be rolling those out this summer.
Senator Harkin. But they'll be voluntary.
Secretary Thompson. Most of them will be at this point.
Senator Harkin. So I won't have to abide by it. I'll put
whatever I want to on it. Rather than putting the total
calories and what that double-cheese, double-whatever-it-is,
and these fries, I might put it on for a 6-ounce portion.
Secretary Thompson. I think we're going to be much more
successful than you think, Senator.
Senator Harkin. Well----
Secretary Thompson. I hope, anyway.
Senator Harkin. Well, we can hope. We can hope. But it
seems to me they've got to be pretty stringent and
straightforward. But if it's voluntarily, you'll get a mismatch
of all kinds of different information on stuff, and they will
try to confuse people, because we've seen that happen in the
past without the kind of things we have on the packaged goods.
And we have a problem there, too, a little bit, as you know,
because they use different sizes. And the FDA is getting ready
to address that, and I applaud that.
Secretary Thompson. Yes, we are.
Senator Harkin. Thank you, Mr. Chairman, for letting me go
over my time.
Senator Specter. Thank you, Senator Harkin.
HEALTH PROFESSIONS
Mr. Secretary, there are three questions that I would like
to state now, and ask you to respond to for the record.
With respect to health professionals, Mr. Secretary, I
would like you to answer, for the record, how we can
realistically cut the $300 million reduction on those programs
in light of the urgent shortage of health professionals,
especially in rural areas. Your budget justifies that by an
additional $25 million to the National Health Service Corps,
which, frankly, I don't see the relationship. But if you would
respond for the record, we would appreciate it.
ABSTINENCE EDUCATION
Number two, on the abstinence initiative, this is a program
that I think is very meritorious, abstinence education, and we
would like a response on the evaluation that your Department is
having as to how well these programs are working.
STEM CELL RESEARCH
And, third, as to stem cells, this continues to be a highly
controversial subject. Those who oppose embryonic stem-cell
research seek to tar those who favor it with the accusation
that human cloning is supported, which, of course, is factually
untrue. It's totally different, nuclear transplantation. But we
would like you to respond as to your evaluation as to the
availability of the 63 lines the President referred to on his
famous declaration, back on August 9, 2001 in his 9 o'clock
speech--the line was expanded to 70--and what has happened
there, and how many of those are really usable, untainted with
mouse feeder, and what is happening elsewhere. We hear periodic
reports, but you are the central figure in the Federal
Government. Give us the specifics on what's going on in South
Korea or other places, or what Harvard is doing with reported
$100 million program, another report about things going on in
Minnesota. And I see these periodically in the press, but we
really ought to collate all of this in one central repository
so we know what is happening on this very important subject,
which is the cutting edge of real opportunity to make inroads
against the most dreaded maladies of the era. I know your
personal thinking on the subject, and I know that--the
complexities of the issue, but, at the minimum, as of this
time, we ought to have the facts before us as to what is
happening there to make a judgement.
Well, thank you very much for coming in, Mr. Secretary.
Secretary Thompson. Thank you, Senator.
Senator Specter. I'd like to meet with you privately for a
moment or two after the hearing.
ADDITIONAL COMMITTEE QUESTIONS
There will be some additional questions which will be
submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Arlen Specter
HEALTH PROFESSIONS
Question. With respect to health professionals, Mr. Secretary, I
would like you to answer, for the record, how we can realistically cut
the $300 million reduction on those programs in light of the urgent
shortage of health professionals, especially in rural areas?
Answer. Over the past two decades, we have invested over $6 billion
on general health professions training grants. However, as we shape
future spending, we will concentrate on directly supporting efforts
that improve health professions shortages, focus on emerging workforce
demands, and meet the needs of the underserved.
The President's budget makes a substantial investment in expanding
access to health care to underserved communities through the Health
Centers program and the National Health Services Corps. In fiscal year
2005, the Health Centers program is on-track to meet the President's
five-year goal to increase access to health care in 1,200 communities
with new and significantly expanded health center sites and increase
the number of people served by over 6 million. Further, the President's
budget supports approximately 2,750 loan repayments and scholarships
for health care professionals in the neediest communities through the
National Health Services Corps program.
The new rural health care investments created by the Medicare
Prescription Drug, Improvement and Modernization Act (MMA) will mean
greater access to hospitals, health professionals and other medical
services for rural seniors. It is estimated that the major rural
provisions of the MMA will increase Medicare spending in rural America
by $20 billion over 10 years. In addition to substantially increasing
Medicare reimbursement for rural hospitals, a focal point for health
care in rural communities, the MMA will also increase reimbursement for
physicians, and other health care providers, in rural areas. For
example, the Act establishes a new 5 percent incentive payment for
physicians practicing in physician scarcity areas which include many
rural communities.
ABSTINENCE
Question. On the abstinence initiative, this is a program that I
think is very meritorious, abstinence education, and we would like a
response on the evaluation that your Department is having as to how
well these programs are working.
Answer. The Department is currently funding two independent,
rigorous, longitudinal evaluations of abstinence education programs.
The first is an on-going evaluation of a select number of State Section
510 abstinence education programs. It is being conducted by Mathematica
Policy Research (MPR). The second evaluation effort is currently in
design phase. It will examine the effectiveness of community-based
abstinence education programs and other approaches to teen pregnancy
and STD prevention. Both of these evaluation efforts are overseen by
the Office of the Assistant Secretary for Planning and Evaluation
(ASPE).
An implementation report from the ongoing MPR evaluation was issued
in April 2002. It documented a wide range of abstinence education
programs that have been well received. They are innovative in their
approach to promoting abstinence as the healthiest choice for youth.
These programs incorporate activities that have been shown to be
effective: an emphasis on goal setting; developing decision-making
skills; getting parents, schools, and communities involved in
supporting the healthy development of youth.
The programs are diverse, creative, and offer youth much more than
a single message of abstinence. Youth responded positively to program
staff who showed a strong and unambiguous commitment to the program
message, and programs that used an intensive set of youth development
services to enhance and support the abstinence message were very well
received. The report showed that addressing peer pressure is difficult,
and many programs have struggled to address these issues and engage
parents in this process. This report also offered a description of the
ways in which programs have partnered with local schools to provide
abstinence education, highlighting some of the challenges to creating
and sustaining these partnerships.
The MPR evaluation has an end date of September 30, 2006. The
original time frame in the statute under which the evaluation project
is operating was through September 2001. However, the contractor and
others have recognized the need for a longer-term follow-up period in
which to examine the program effects on youth. As a result, the
contract period has been extended through September 2006.
ASPE is also in the process of designing an evaluation of
community-based abstinence education activities and other approaches to
teen pregnancy and STD prevention. ASPE contracted Abt Associates to
develop evaluation designs for a longitudinal, rigorous impact study,
which will help best answer some of the original policy questions that
were the impetus for this study. The study will follow adolescents
through high school, and will measure the impact of these programs on
behavioral outcomes, including the reduction and prevention of out-of-
wedlock pregnancies and sexually transmitted diseases (both viral and
bacterial). Other key outcome variables of interest include age at
first sexual activity and intercourse, frequency of sexual activity and
intercourse, and number of individuals who postpone sexual activity or
intercourse through adolescence.
STEM CELL RESEARCH
Question.What is the status of the human embryonic stem cell (hESC)
derivations listed on the NIH Stem Cell Registry? How many are in
private hands? How many have been grown on mouse feeder layers? How
many are viable?
Answer. All of the derivations listed on the NIH Human Embryonic
Stem Cell Registry are privately owned by 15 different companies or
academic institutions. The providers indicated by an asterisk (*) below
are recipients of the NIH Infrastructure award to develop, characterize
and distribute cell lines.
BresaGen, Inc., Athens, Georgia*
--4 derivations
--3 lines available
--The cells in derivation BG04/hESBGN-04 failed to expand into
undifferentiated cell cultures.
Cell & Gene Therapy Research Institute (Pochon CHA University),
Seoul Korea
--2 derivations
--0 lines available
Cellartis (formerly Cell Therapeutics Scandinavia), Goteborg,
Sweden*
--3 derivations
--2 lines available
--Cell line SA03/Salgrenska 3 was withdrawn by donor.
CyThera, Inc., San Diego, California*
--9 derivations
--0 lines available
--The cells failed to expand into undifferentiated cell cultures.
ES Cell International, Melbourne, Australia*
--6 derivations
--6 lines available
Geron Corporation, Menlo Park, California
--7 derivations, all duplicates of Wisconsin Alumni Research Fdn.
derivations
Goteborg University, Goteborg, Sweden
--16 derivations, reported to have not been exposed to mouse feeder
layers
--0 lines available
Karolinska Institute, Stockholm, Sweden*
--6 derivations
--0 lines available
--The cells failed to expand into undifferentiated cell cultures.
Maria Biotech Co. Ltd.--Maria Infertility Hospital Medical
Institute, Seoul, Korea
--3 derivations
--0 lines available
MizMedi Hospital--Seoul National University, Seoul, Korea*
--1 derivation
--1 line available
National Centre for Biological Science/Tata Institute of
Fundamental Research, Bangalore, India
--3 derivations
--0 lines available
Reliance Life Sciences, Mumbai, India
--7 derivations
--0 lines available
Technion-Israel Institute of Technology, Haifa, Israel*
--4 derivations
--2 lines available
University of California, San Francisco, California*
--2 derivations
--2 lines available
Wisconsin Alumni Research Foundation, Madison, Wisconsin*
--5 derivations
--5 lines available
Of the 78 entries on the Registry, 71 are from independent embryos
and 7 are duplicates located at both WiCell (Wisconsin Alumni Research
Fdn.) and Geron. The Geron cell lines are not being widely distributed
to the research community.
Of the 71 independent derivations:
--16 have failed to expand into self renewing, pluripotent cell lines
(9 at CyThera, 1 at BresaGen, 6 at Karolinska), and 1 line was
withdrawn by the donor at Cellartis (formerly Cell Therapeutics
Scandinavia, CTS). NIH provided Infrastructure support in
failed attempts to expand these 16 derivations into
distribution-quality cell lines.
--Of the remaining 54 independent derivations, 21 are available for
shipment, after expansion and characterization using NIH
Infrastructure grant awards. The 21 that are currently
available are:
BresaGen, Inc.--BG01, BG02, BG03
Cellartis--SA01, SA02
ES Cell International--ES01, ES02, ES03, ES04, ES05,
ES06 4
MizMedi Hospital--MI01
4Technion-Israel--TE03, TE06
UCSF--UC01, UC06
WiCell--WA01, WA07, WA09, WA13, WA14
--Of the remaining 33 independent derivations, 2 more are at
institutions with NIH Infrastructure awards. If these 2 were
developed into distribution quality cell lines ready for
shipment, there would be 23 independent cell lines available to
the research community. The 2 cell lines under development are:
Technion-Israel--TE04, TE07
--The remaining 31 independent derivations are all at institutions
located outside of the United States that have not applied for
NIH Infrastructure awards to develop their cell lines. Any
plans to develop these derivations into cell lines that are
available to the research community are unclear at this time.
The 31 derivations at institutions that do not have
Infrastructure awards are:
Pochon CHA (Korea)--2 derivations
Goteborg Univ. (Sweden)--16 derivations
Maria Biotech (Korea)--3 derivations
National Centre for Biological Sciences (India)--3
derivations
Reliance Life Sciences (India)--7 derivations
As far as we know, all derivations have been exposed to mouse
feeder cells, with the exception of the 16 derivations at Goteborg
University (Sweden).
Information on the detailed characteristics of each of the
derivations is available on the NIH Human Embryonic Stem Cell Registry,
http://escr.nih.gov.
Question. What is Happening at Harvard University?
Answer. On March 25, 2004, Harvard University announced the
derivation of 17 hESC lines in an article published in the New England
Journal of Medicine. Funding for the derivations and distribution of
these lines is being provided by the Howard Hughes Medical Institute,
Juvenile Diabetes Research Foundation and Harvard University.
On April 23, Harvard University announced the establishment of the
Harvard Stem Cell Institute. According to Harvard, the Institute will
encourage adult and embryonic stem cell research using both animal and
human stem cells. The Institute has two co-directors: Harvard Medical
School Professor David Scadden, who also directs Massachusetts General
Hospital's Center for Regenerative Medicine and Technology, and Douglas
Melton, the Thomas Dudley Cabot Professor of the Natural Sciences and a
Howard Hughes Medical Institute investigator.
Research at the Institute will be focused on five areas of disease
for which stem cell therapy seems most promising. The diseases all
result from some sort of organ or tissue failure and include: diabetes,
neurodegenerative diseases, blood diseases, immune diseases,
cardiovascular disease, and musculoskeletal diseases.
Although research on the 17 new human embryonic stem cell (hESC)
derivations are not eligible for Federal funding, NIH is currently
supporting several scientists at Harvard University whose hESC research
use lines eligible for Federal funding. Dr. Doug Melton is working to
identify the genes involved in hESC self-renewal and differentiation.
Dr. George Daley is studying hematopoietic development from hESCs. Dr.
Howard Green is working to develop the culture conditions to coax hESCs
to become the keratinocytes that make up human skin's epidermis. Dr.
Jeffrey Harper is analyzing the signals that control hESC division.
Question. What is Happening in South Korea? What is Happening in
Other Countries?
Answer. On February 12, 2004, South Korean researchers published
the first scientifically credible report of the creation of a cloned
human embryo in the laboratory by means of somatic cell nuclear
transfer (SCNT) (Science 303: 1669-1674.) These scientists, supported
by the South Korean government, then used these cloned embryos to
establish a human embryonic stem cell line. They combined the DNA of a
woman's ovary cell with her donated egg, from which the nucleus had
been removed, and then stimulated the newly combined cell to divide.
The resulting very early embryo was then allowed to develop to the
blastocyst stage (five to nine days), at which point it was
disaggregated and the highly potent stem cells of the inner cell mass
were removed. These stem cells were then treated to produce a stem cell
line to be used for various kinds of biomedical research. Subsequent to
the publication of the SCNT study, the South Korean government voted to
ban the creation of cloned human embryos, but might allow cloning for
biomedical research on a case-by-case for medical treatment subject to
approval by a National Bioethics Advisory Commission. Scientists will
be permitted to use spare frozen embryos, left over from infertility
treatments and kept in laboratories for at least five years, for
limited stem cell research into treatments for hard-to-cure diseases.
The regulations banning human cloning are expected to come into effect
after President Roh Moo-hyun signs the bill. The regulations on stem
cell research will go into effect in 2005.
Other International Stem Cell Efforts
International Society for Stem Cell Research (ISSCR)
The International Society for Stem Cell Research is an independent,
nonprofit organization established to promote and foster the exchange
and dissemination of information and ideas relating to stem cells, to
encourage the general field of research involving stem cells and to
promote professional and public education in all areas of stem cell
research and application. Opinions on the legitimacy of experiments
using human embryos vary among members of the European Union (EU)
according to the different ethical, philosophical and religious
principles in which they are grounded. EU member states have taken very
different positions on the regulation of human embryonic stem cell
research and cloning for biomedical research. More information about
the regulations and policies of EU members can be found on the website
of the ISSCR at the following link: http://www.isscr.org/scientists/
legislative.htm.
The International Stem Cell Forum (ISCF)
The ISCF was founded in January 2003 to encourage international
collaboration and funding support for stem cell research, with the
overall aim of promoting global good practice and accelerating progress
in this vitally important area of biomedical science. The Forum's long-
term aim is to help stem cell scientists achieve a range of
revolutionary medical advances that will benefit people throughout the
world. The ISCF is led by the United Kingdom's Medical Research Council
and consists of 14 leading supporters of stem cell research from around
the world. Member organizations are based in the United States,
Finland, Australia, Canada, Germany, France, Israel, Netherlands,
Japan, Singapore, Sweden, Switzerland, and the United Kingdom. Within
ISCF, the United States is represented by the NIH. The Juvenile
Diabetes Research Foundation International (JDRF) is also a member of
the ISCF. One short term goal of the ISCF is to compare different stem
cell lines from the member organizations. As part of this goal, NIH's
federally approved stem cell lines will be compared to those of other
member organizations. Information about the stem cell research efforts
of the member organizations can be found on the website: http://
mrc.live.tmg.co.uk/.
PREPARED STATEMENT RECEIVED
Senator Specter. We have received the prepared statement of
Senator Mary L. Landrieu. The statement will be placed in the
hearing record.
[The statement follows:]
Prepared Statement of Senator Mary L. Landrieu
With the release of the 2005 budget, President Bush emphasized his
commitment to reducing the deficit, most of which has been created by
his fiscally irresponsible policies, within five years. The overall
budget proposed by the President cuts domestic discretionary spending
outside of homeland security by $49 billion by 2009, a 12 percent cut
in spending. A large portion of the domestic discretionary spending
that the Administration proposes to cut from 2005-2009 is administered
by the Department of Health and Human Services and provides services
such as child care, child welfare, and health care to our poorest
children, families, and seniors.
Because it is an election year, the Administration has attempted to
hide their lack of support for domestic spending by playing a shell
game. When questioned about their commitment to important social
issues, the Administration touts its minor increases in some programs
in the 2005 budget as evidence of their ``compassionate conservatism.''
Yet, if you look closely enough you will see that after this year,
these ``increases'' continue to shrink until they sink below current
funding levels by 2009.
Although I am supportive of almost any policy aimed at bringing the
economy back into an era of surpluses, as we enjoyed during the Clinton
years, I believe the President's method for trying to achieve a
reduction in deficits through cuts in spending on our most vulnerable
populations is at best, flawed. Because domestic discretionary spending
outside of homeland security only accounts for one-sixth of the overall
budget, the President's proposed cuts would not significantly reduce
the deficit. What they will do, however, is increase financial burdens
on states at a time when they are experiencing the worst fiscal crises
since WW II. estimates show that states will face deficits of $40
billion or more in 2005. It is predicated that my own state of
Louisiana will face a deficit of $500 million this year. Under the
decreased federal funding in the President's new budget, Louisiana and
other states will be forced to impose deeper cuts on programs such as
government subsidized health insurance and child care subsidies for the
poor.
In his budget, President Bush does not limit his cuts to
discretionary spending but also proposes cuts in entitlement spending
for many of these programs. It is unbelievable to me that in a time of
a recession, this President proposes to cut support for TANF, child
care, child welfare, and other social services by over $2.8 billion.
While his TANF re-authorization calls for increases in the number
of hours that fathers and mothers must work, the budget flat funds
child care assistance to these families. Over the last year 100,000
children have lost assistance and predictions indicate that at least an
additional 200,000 children will lose assistance by 2009 under the
current budget proposal. The TANF entitlements funds are also flat-
funded, though 8.2 million people are unemployed and more families are
at risk of reliance on the welfare system. And although President
Bush's policies have contributed greatly to the dire situation many of
these families face, he continues to turn his back on them by refusing
to provide adequate funding to the government programs that will allow
them to survive these difficult times.
The Administration's proposal for health care reflects an equal
lack of compassion towards these low-income families. Our country's
problem of the uninsured has reached a crisis level, with almost 44
million individuals who are not insured. Predictions show this problem
is getting even worse. Yet, the Administration is proposing further
cuts in aid to low-income individuals through Medicaid, calling for a
reduction in funding for Medicaid by nearly $1 billion in 2005 and by
nearly $16 billion over the next ten years. And the President is
attempting to unload this crisis onto states by pushing for turning
Medicaid into a block grant. The result would be a cap on the amount of
money the federal government would spend on this program and a shift of
costs to the states, preventing them from being able to respond to the
dynamic health care needs of their residents.
President Bush is proposing a similar funding structure for foster
care payments to states. Under this proposal, states would be given the
option to receive block grants in place of entitlement funding that is
typically provided for services to foster children. These block grants
would freeze funding to states at a specific level for five years,
meaning that the funds would no longer be based on need or the number
of eligible children. This cost neutral proposal does not increase
funding to a foster care system that is already under-funded. In fact,
many programs that have been block-granted in the past have ended up
with less funding over time. Although I do support a federal funding
structure for child welfare services that allows states the flexibility
to be innovative in meeting the challenges of families involved in this
system, the President's proposal of block granting will ultimately
result in states having less resources to provide necessary services.
Understanding that these families face complex and varying
challenges, I support the President's budget proposal that would
increase funding for Promoting Safe and Stable Families to $505
million. This program offers flexible funding to states for a range of
community-based family support and adoption services. This money can be
used for prevention and family preservation services that help to keep
children with their biological families and out of the child welfare
system. Although I am happy to see that the Administration has
recognized the importance of this program by proposing increased
funding, I hope that it will modify proposals for other child welfare
programs to provide adequate funding to assist families.
Investments in programs that focus on prevention, such as those
provided through the Promoting Safe and Stable Families funding, are
cost-saving. By investing in these primary services, our government
avoids investment in solving problems that could have been prevented.
Unfortunately, the President's budget proposal for substance abuse
services under the Substance Abuse and Mental Health Administration
does not reflect this idea, with over 2\1/2\ times the amount of
funding proposed for prevention services dedicated to treatment
services. I support the increases that President Bush is proposing for
these treatment services, for this funding will aid in the healing of
individuals and families who suffer from substance abuse issues.
However, I further support increases in funding for prevention
services, so that we can help families avoid the problems associated
with substance abuse.
As lawmakers and appropriators, we have the responsibility to act
on the idea that we can always do more to help the people we represent.
We cannot be complacent with this budget. Much more can be done for
some of our most vulnerable populations that are served through the
Department of Health and Human Services than what is outlined in the
President's budget. Using my seat on the Appropriations committee, I am
committed to seeing valuable programs proposed to receive cuts by the
Administration receive the funding that is necessary to meet the needs
of those they are intended to serve.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 9:30 a.m., Thursday, April
1, in room SH-216. At that time we will hear testimony from the
Honorable Elias Zerhouni, Director, National Institutes of
Health.
[Whereupon, at 10:35 a.m., Thursday, March 25, the
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
April 1.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005
----------
THURSDAY, APRIL 1, 2004
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:30 a.m., in room SH-216, Hart
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, Stevens, and Harkin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF ELIAS A. ZERHOUNI, M.D., DIRECTOR
ACCOMPANIED BY:
RAYNARD KINGTON, M.D., Ph.D., DEPUTY DIRECTOR, OFFICE OF THE
DIRECTOR
WILLIAM R. BELDON, DEPUTY ASSISTANT SECRETARY FOR BUDGET
DUANE ALEXANDER, M.D., DIRECTOR, NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT
BARBARA ALVING, M.D., ACTING DIRECTOR, NATIONAL HEART, LUNG,
AND BLOOD INSTITUTE
JAMES F. BATTEY, JR., M.D., Ph.D., NATIONAL INSTITUTE ON
DEAFNESS AND OTHER COMMUNICATION DISORDERS
JEREMY M. BERG, DIRECTOR, NATIONAL INSTITUTE OF GENERAL MEDICAL
SCIENCES
FRANCIS S. COLLINS, M.D., Ph.D., DIRECTOR, NATIONAL HUMAN
GENOME RESEARCH INSTITUTE
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES
PATRICIA A. GRADY, Ph.D., DIRECTOR, NATIONAL INSTITUTE OF
NURSING RESEARCH
RICHARD J. HODES, M.D., NATIONAL INSTITUTE OF AGING
SHARON H. HRYNKOW, ACTING DIRECTOR, FOGARTY INTERNATIONAL
CENTER
THOMAS R. INSEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF MENTAL
HEALTH
STEPHEN I. KATZ, M.D., Ph.D., DIRECTOR, NATIONAL INSTITUTE OF
ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
STORY C. LANDIS, Ph.D., DIRECTOR, NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND STROKE
TING-KAI LI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALCOHOL
ABUSE AND ALCOHOLISM
DONALD A.B. LINDBERG, M.D., DIRECTOR, NATIONAL LIBRARY OF
MEDICINE
KENNETH OLDEN, Ph.D., S.C.D., L.H.D., DIRECTOR, NATIONAL
INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
RODERIC I. PETTIGREW, Ph.D., M.D., DIRECTOR, NATIONAL INSTITUTE
OF BIOMEDICAL IMAGING AND BIOENGINEERING
JOHN RUFFIN, Ph.D., DIRECTOR, NATIONAL CENTER ON MINORITY
HEALTH AND HEALTH DISPARITIES
PAUL A. SIEVING, M.D., Ph.D., DIRECTOR, NATIONAL EYE INSTITUTE
ALLEN M. SPIEGEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF
DIABETES AND DIGESTIVE AND KIDNEY DISEASES
STEPHEN E. STRAUS, M.D., NATIONAL CENTER FOR COMPLEMENTARY AND
ALTERNATIVE MEDICINE
LAWRENCE A. TABAK, D.D.S., Ph.D., NATIONAL INSTITUTE OF DENTAL
AND CRANIOFACIAL DISEASES
JUDITH L. VAITUKAITIS, M.D., DIRECTOR, NATIONAL CENTER FOR
RESEARCH RESOURCES
NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG
ABUSE
ANDREW C. VON ESCHENBACH, M.D., DIRECTOR, NATIONAL CANCER
INSTITUTE
JACK WHITESCARVER, Ph.D., DIRECTOR, OFFICE OF AIDS RESEARCH
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
time is precisely 9:30, which is our starting time, and the
Appropriations Subcommittee on Labor, Health, Human Services,
and Education will now proceed.
Today we will consider the appropriations process as it
applies to the National Institutes of Health. And as I have
stated on many occasions, I consider NIH the crown jewel of the
Federal Government. It may be the only jewel of the Federal
Government.
But medical science and humanity is deeply indebted to the
extraordinary work which has come out of medical research from
the National Institutes of Health.
The budget process is always complicated and a goal was
established to double NIH funding, which we have more than met.
When asked what would happen after doubling, as you know, my
response was instantaneous and obvious, and it was tripling. It
would be too hard to quadruple it before you triple it.
When I took over the chairmanship of this subcommittee in
January 1995, I took a look at the priorities and thought this
was none higher, really at the top of the list. And Senator
Harkin, the ranking member, agrees. We know around here if you
want to get something done, you have to cross party lines.
Sometimes it gets you into trouble if you have a primary
election campaign. My opponent thinks I should not talk to
Democrats. But Senator Harkin and I, when we have changed the
gavel, it has been seamless and we have proceeded to give
tremendous support to NIH.
We have a very tight discretionary budget this year. It is
up one-half of 1 percent, and that is very, very, very
difficult. The administration has put in a figure of $729
million over the $28.5 billion budget, and as I am sure you
know, we offered an amendment to increase it by $1.3 billion
and we were successful, 72 to 24.
But there were some strenuous arguments raised by my
colleagues in the Senate that NIH was getting too much funding
compared to other important research Departments in the Federal
Government. And when one of my colleagues made an impassioned
plea, I agreed with him that the other Departments were not
getting adequate funding. But that did not bear on not
adequately funding NIH. And what it takes is the subcommittee
chairmen to pick up those important research projects and take
the lead and get them funded.
We have a Federal budget of $2,400,000,000,000. Do you know
how much money that is? Well, nobody else does either.
They say if you took a room this size, it would be
insufficient to stuff $10,000 bills into it.
We can afford money for research. That is the best
investment that we are making beyond any question. But it is a
fight.
NIH has its own problems which you know about, challenges
on conflicts of interest, which we have addressed in a separate
hearing and we will talk about today, the issues about
compensation, an issue which I know is being addressed.
NIH is being attacked on an ideological level. The November
28, 2003 edition of Science had an editorial marked Don't Let
Ideology Trump Science. An amendment was offered in the House
of Representatives to strike four NIH grants because sex was
mentioned in the title, peer-reviewed. One of them involved a
question of spread of venereal disease at truck stops where
truckers are highly vulnerable, long stops, fatigue, away from
home, places frequented understandably by prostitutes, and NIH
wanted to make a study. And that and three other of your
projects were challenged because if you have sex in the title,
it makes a good 30-second commercial, if you voted for it, to
defeat you. The surprising thing was that in the House of
Representatives the amendment almost passed: 212 to 210.
Now, it just happens that the amendment was offered by the
fellow who wants to take my seat on the U.S. Senate who has
voted against every domestic spending bill, voted against Head
Start, voted against Medicare reform, voted against the budget
for Labor, Health and Human Services, voted against the budget
for NIH. So in this town you have to be prepared to defend
yourself against attacks. So if you have one or two, Dr.
Zerhouni, do not think you are being discriminated against.
It goes with the territory. I think it is within your pay
grade to defend yourself, Dr. Zerhouni, and to prevail, and I
think it is within my pay grade to prevail also. But it is a
battle.
So much for an opening statement. I read it just like Betty
Lou wrote it for me.
Super Senator Taylor. She is not just a regular Senator.
She is a super Senator.
Dr. Elias Adam Zerhouni began his tenure as the 15th
Director of NIH on May 20, 2000. He had a very distinguished
career prior to coming to NIH: executive vice dean of Johns
Hopkins University School of Medicine, Chair of the Department
of Radiology; Martin Donner Professor of Radiology; medical
degree from the University of Algiers School of Medicine; and
residency in diagnostic radiology at Johns Hopkins. Thank you
for joining us, Dr. Zerhouni, and we look forward to your
testimony.
SUMMARY STATEMENT OF DR. ELIAS ZERHOUNI
Dr. Zerhouni. Thank you, Mr. Chairman. It is our pleasure
to be here with the 27 institute and center directors of NIH to
present our budget, but also to express our thanks and
appreciation for your strong leadership on behalf of research
and medical research and NIH.
INTRODUCTION OF NEW INSTITUTE DIRECTORS
I would like to start by introducing three of our new
directors, and I will ask them to stand up to be introduced to
you, Mr. Chairman.
Dr. Story Landis is now the Director of the National
Institute of Neurological Diseases. She has been appointed in
the past year and has done an outstanding job already working
with all aspects of neurological disorders, including
collaboration with patient groups in trying to find the best
approaches to rising threats of neurological degenerative
diseases.
Dr. Nora Volkow is the new Director of the National
Institute of Drug Abuse. She has joined us from the Brookhaven
National Laboratory in Stony Brook University. She is a leader
in imaging of drug addiction and has already changed the
strategy of her institute in many appropriate ways.
Dr. Jeremy Berg is the new Director of the National
Institute of General Medical Sciences. Dr. Jeremy Berg joined
us from Johns Hopkins where he was the Chair of the Basic
Science Institute at Johns Hopkins and Chair of the Department
of Biophysics.
I also would like to mention two acting Directors, Dr.
Barbara Alving, who is the acting Director of NHLBI, and Dr.
Sharon Hrynkow, who is the acting Director of the Fogarty
International Center.
BREAKTHROUGHS AND ADVANCES
Mr. Chairman, members of the committee, it is my pleasure
to actually summarize the written testimony that we submitted
to you. What I would like to do is go right away and tell you
how important your investment has been in terms of specific
breakthroughs and advances between last year and this year.
NIH developed a completely new Ebola vaccine that can
protect the population in less than a month. This a real
breakthrough in biodefense.
Just 2 days ago, NIAID announced that a new SARS
experimental vaccine has been successful in animal experiments
and will enter human trials as soon as we can do so. This is
less than a year after the SARS epidemics which we knew not the
cause of and it took us several weeks to find the cause. A year
later, we are ready to fight this disease if it reappears.
We discovered in 2003 several genes, for the first time,
associated with schizophrenia. This was ranked as the number
two advanced scientific advance of 2003, following the
discovery of dark matter in the universe.
We identified just 3 weeks ago a new master switch gene
relating to type 2 diabetes. This is a very important discovery
that will help us in discovering how type 2 diabetes develops.
We have changed the practice paradigm of long-term hormone
replacement therapy for women because of the landmark studies
of the Women's Health Initiative.
Today on the cover of Nature magazine, we are announcing
the completion of the rat genome, a very important advance. As
you know, by 2005 we were hoping to only have the human genome
available to us. We now have the mouse, the rat, and the human
genome, and we will be able to do comparative analysis that
will advance our understanding of biology and disease.
NIH ROADMAP FOR MEDICAL RESEARCH
All throughout the past 2 years, we have also taken into
account the need for new science strategies, and this is what
we call the NIH roadmap for medical research. The roadmap is
essentially our effort to find ways to accelerate basic
research discoveries and speed the translation of those
discoveries into clinical practice. It is a dedicated effort to
explicitly address roadblocks that slow the pace of medical
research in improving the health of the American people.
The major driver for this approach is exemplified on this
slide in front of you, and that is that we need to transform
medical research in the 21st century. In the 20th century, we
treated disease when symptoms appeared and normal function had
been lost. Why was that? Because for the past 5,000 years and
the 20th century included, we did not understand the molecular
and cellular events that led to disease. So we had to wait
until the disease was explicit. And this is very expensive in
both financial and disability costs.
The paradigm of the 21st century is that we will intervene
before symptoms appear and preserve normal function for as long
as possible because we do understand much better the genetic
events that lead to disease.
We have come up with very bold initiatives. We will
integrate all clinical research networks that are under NIH
throughout the country and link them to community physicians to
form new communities of research that will translate much
quicker, much more efficiently than we have in the past the
benefits of our fundamental understanding of research.
A good example is juvenile rheumatic diseases, a disease
set that affects only 300,000 children in the country. To do
good research and have enough understanding of what happens, we
need to recruit patients across the Nation, and this will be
facilitated by a project of the roadmap called National
Clinical Research Networks with trained community physicians in
every community linked to academic centers.
We continue to invest across NIH in a combined and
coordinated fashion to advance medical research as fast as we
can. This year we are requesting $237 million for the roadmap.
STEWARDSHIP
We have continued also to focus on management excellence
and stewardship of our resources. Let me point out two very
simple statistics. Our funding went up by 141 percent in the
past 10 years, almost 2 and a half times, 2.4 times. Our FTE's,
the number of people, at NIH needed to manage this portfolio
has only increased by 16 percent. Why? Because we have
aggressively used modern methods of management using
information systems to prevent the need for us to increase our
FTE numbers. Our Research Management and Support budget has
gone from 4 percent of our budget to 3.5 percent of our budget.
So we are doing what you are asking us to do and being very
good stewards.
As you said, we will have on May 6 a final meeting of the
Advisory Committee to the Director to finalize the
recommendations of the Blue Ribbon Panel for conflict of
interest and will report back to you as soon as we have that.
FISCAL YEAR 2005 BUDGET REQUEST
Mr. Chairman, we are requesting a budget of $28.607 billion
which is $28.527 billion from this committee, and a 2.6 percent
increase over 2004. We also have at our program level $47
million for nuclear and radiological countermeasures which are
housed in the Public Health Service emergency fund.
PREPARED STATEMENT
We are pleased to be here and will answer any of your
questions. Again, we would like to thank the bipartisan support
of this committee over the years. Thank you, Mr. Chairman.
[The statements follow:]
Prepared Statement of Dr. Elias A. Zerhouni
Good morning, Mr. Chairman and members of the Committee. Let me
begin by expressing my deepest appreciation to the Congress, Secretary
Thompson, President Bush, and the American people for their generous
and bipartisan support of the NIH's efforts to help improve the health
of all our citizens. I respect the extraordinary effort of this
committee and, Mr. Chairman, your leadership as well. I thank you for
it.
The year 2004 marks a sea change for the NIH and its Roadmap for
Medical Research. We are refining our basic and clinical research
programs to ensure that new discoveries rapidly lead to new and
improved diagnostics, treatments and prevention strategies that extend
the length and improve the quality of human life.
In my testimony today, I want to cover four areas: first, highlight
several key research advances that took place in the last year which
represent the critical contributions of NIH intramural researchers and
grantees; second, give examples of how the NIH Roadmap effort will help
shape our approach to patient-oriented research; third, offer examples
of our stewardship; and fourth, present an overview of our budget. In
the course of my testimony, I will mention emerging priorities and our
plans for responding to the health challenges ahead.
BREAKTHROUGHS & ADVANCES
Each year, the public investment in research yields critical
scientific advances. The four I highlight here are just a sample of the
many that represent the development of new and improved treatments,
diagnostics, or prevention strategies that will affect the health of
the entire nation.
Few viruses are feared more than the Ebola, a deadly microbe that
causes outbreaks in Africa and Asia and kills up to 90 percent of those
it infects. Scientists at the NIH National Institute of Allergy and
Infectious Diseases Vaccine Research Center developed a single dose,
fast-acting, experimental Ebola vaccine that successfully protects
monkeys after just one month, and human trials are now under way.
This year NIH research further elucidated the role of widely used
hormone replacement therapies. The NIH halted the estrogen alone study
of the Women's Health Initiative on March 1, 2004 after 5.6 years of
follow-up, due to increased risk of stroke. You will recall that NIH,
in 2002, stopped the combination hormone trial arm of the Women's
Health Initiative early due to an increased risk of invasive breast
cancer, coronary heart disease, stroke, and pulmonary embolism in study
participants on estrogen plus progestin compared to women taking
placebo. It indicated that healthy postmenopausal women taking
combination hormone therapy also suffered twice the rate of dementia as
those taking a placebo. Together, the results of these clinical studies
changed conventional dogma, and provided important new evidenced-based
information to women who are deciding whether to begin or how long to
continue menopausal hormone therapy. These trials clearly are having a
major impact on the health of people we know and love--our wives, our
sisters, our daughters and our mothers.
The third advance was the discovery of genes associated with
schizophrenia, which is a profoundly disabling disorder that affects
one percent of the adult population. It is marked by hallucinations,
delusions, social withdrawal, flattened emotions, and loss of social
and personal care skills.
Research like this on the genetics of mental illness was named the
Number 2 scientific ``breakthrough of the year'' for 2003 by the
prestigious peer-reviewed journal, Science. Most of this work was
funded by NIH and included discoveries of candidate genes for
schizophrenia, depression, anxiety and bipolar disorders. These
discoveries bring us closer to developing new diagnostic tests,
strategies for prevention, and targets for the treatment of
schizophrenia and other mental disorders.
The fourth advance came only three weeks ago, when NIH announced a
major new discovery, the identification of a common variation of a
pancreatic ``master switch'' gene that increases the risk of type 2
diabetes by 30 percent. Type 2 diabetes now affects 17 million people
in the United States, and is responsible for enormous health care
costs. This gene discovery opens the door to the development of new and
more effective methods of prevention and treatment.
NIH ROADMAP
Let me now turn your attention to the NIH Roadmap for Medical
Research. I want to tell you why the Roadmap is so important to the
future of medical research and to innovations in improving people's
health. I also want to give you some examples of how we at NIH expect
the Roadmap to change the way we do research and the practice of
medicine.
One of the questions we face is how do we successfully do our part
in the battle to contain health costs? We need to address the following
issues: What are the roadblocks? What are the major challenges? How can
we most effectively invest the funds that the American taxpayers
entrust to us to fashion the fastest track to discovery as well as
translate those discoveries to the patient's bedside or the doctor's
office?
In seeking answers to these questions, one thing becomes clear. The
traditional paradigm of medical care--when practitioners waited for the
disease to cause the patient the loss of some function--must be
replaced by a paradigm where health professionals act before the
individual loses any function. This has become even more critical since
chronic diseases now consume about 75 percent of our fast-growing
health care expenditures.
Let me present four examples of how the NIH Roadmap will transform
our approach to biomedical research in specific disease areas.
The first example is schizophrenia, a disorder that--as I mentioned
earlier--affects one percent of the U.S. population. The peak onset
occurs between the ages of 18 and 25. Schizophrenia has the hallmarks
of both a neurodevelopmental and a neurodegenerative disease. But after
100 years of neuropathological study, we still lack knowledge of the
precise cause of the disorder.
Today, schizophrenia is the fifth leading cause of years lost due
to disability among Americans from ages 15-44. Although we can treat
the so-called ``positive'' symptoms, such as hallucinations and
delusions, we do not yet have treatments for the ``negative'' symptoms,
like withdrawal and cognitive deficits. And these are the largest
source of disability.
Less than 30 percent of people with this illness are currently
employed. And people with schizophrenia represent one of the largest
groups on atypical antipsychotics as the treatment of choice. In 2001,
Medicaid paid for more than 50 percent of the total spending on
atypical antipsychotics, amounting to $2.7 billion, a figure which has
been growing at roughly 25 percent a year for the past 3 years.
Today, we lack a diagnostic test or a strategy for preventing
schizophrenia. This situation is similar to cardiovascular disease 30
years ago in that we see schizophrenic patients only after their first
``heart attack,'' that is, episode, and we do not have the equivalent
of cholesterol as an identifiable risk factor.
However, what we have done recently--and what holds great promise
for those who are suffering--is identify 12 genes associated with risk.
Our challenge now is to move from the discovery of those genes--most of
which have no known function--to understand the role these genes play
in the onset and progression of this brain disease--and do something
about it.
Our hope is to use these genes to identify what is abnormal in the
brains of schizophrenics, identify it early and thus provide the
psychiatric equivalent of serum cholesterol. To accomplish this, we
must study the protein products of these genes by using molecular tools
that can make their function transparent.
It is precisely here that the NIH Roadmap will help accelerate the
effort to study protein products through so-called molecular
libraries--databases of information on small molecule compounds like
aspirin and antihistamines. These libraries will let researchers screen
hundreds of thousands of small molecules to yield these tools.
For example, we know that a variation in the neuregulin gene is
associated with an increased risk for schizophrenia. To understand how
this gene confers risk, we need to find chemicals that mimic or inhibit
the gene's function. This would give us a precise description of how
alterations in the gene change the activity of brain cells. Molecular
libraries will not only yield the tools to study the neuregulin gene
but also provide a test for vulnerability to schizophrenia. With such
tools and tests, doctors could approach risk for schizophrenia the way
we currently approach risk for heart disease.
A second example where the NIH Roadmap offers promise is in
pediatric diseases, through the creation of clinical research networks.
Uncommon disorders like the juvenile forms of rheumatic diseases,
such as arthritis, lupus and dermatomyositis, affect 300,000 children
in the United States. Not one of these diseases is common enough to be
studied intensively at any one academic health center. Thus, many such
centers as well as community-based pediatricians are needed to collect
a sufficient group of patients who can participate in these studies to
gather meaningful results.
The development of clinical research networks that focus on chronic
childhood diseases--like those already established for childhood
cancers--and the potential to include community physicians trained in
clinical research methodology in the research process will enable
clinical trials to be more efficient and effective.
Using the NIH Roadmap clinical research networks concept, this
could occur without building a new, and often very expensive,
infrastructure for every new trial. Including community-based
pediatricians as full partners in the research will allow us to
overcome some of the limitations of patient recruitment that we
currently experience and enable more children to participate in these
trials, and accelerate the development of new treatments.
The third example is Alzheimer's Disease (AD). We have made
considerable progress in understanding Alzheimer's Disease. Fifteen
years ago, we knew none of the genes that cause AD and we had only a
limited understanding of the biological pathways involved in the
development of brain pathology. Ten years ago, we could not model the
disease in animals. Five years ago, we were not funding any prevention
trials and had no way of identifying persons at high risk for the
disease. And, as recently as one year ago, we had no way of imaging
AD's characteristic amyloid plaques in a living person.
Today, we can do all of these things. And we are poised to make the
discoveries that will transform our understanding of the basic and
clinical aspects of AD and enable us to effectively prevent, diagnose,
and treat it using several NIH Roadmap initiatives.
Through basic research in Alzheimer's disease, we identified a
number of brain pathways that are potential targets for preventive
interventions. These range from dysfunction and death of specific
neurons to loss of the connections between neurons. Roadmap efforts to
improve imaging of small molecules will let us visualize the effects of
treatments more rapidly and accurately, which could make effective AD
clinical trials smaller, faster and more affordable.
My fourth and final example is cardiovascular disease. One of the
greatest public health success stories of the last half century is the
dramatic reductions in mortality from cardiovascular diseases. Studies
initiated by the NIH--the Framingham Heart Study and the Lipid Research
Clinics Coronary Primary Prevention Trial--have been key to that
success. They helped not only to identify risk factors that contribute
to the development of cardiovascular diseases, but also to demonstrate
the efficacy of therapeutic interventions to control them.
Even so, cardiovascular disease remains an enormous health burden,
accounting for 38 percent of all deaths in the United States in 2001.
Progress in reducing that burden will require continued efforts to
refine our understanding of risk factors, such as obesity and high
cholesterol, and to identify and evaluate new prevention approaches.
This means that large scale population-based studies will remain a
critical component of our research effort.
The NIH Roadmap will help fashion the interactive network and
involvement of many community-based practitioners. For example, we can
make better use of large-scale organizations set up for single studies,
such as the recently completed Antihypertensive and Lipid-Lowering
Treatment to Prevent Heart Attack Trial (ALLHAT). Instead of disbanding
it, we can involve many or all of the investigators in other trials
addressing not only cardiovascular disease but also other diseases. The
National Electronic Clinical Trials and Research (NECTAR) initiative--a
critical part of the Roadmap effort to re-engineer clinical research--
will enable data sharing and enhance comparison and aggregation of
results from multiple trials by using standard definitions of outcomes
and adverse events. In the future, patients will know directly from
their own community doctors, who will be equipped with the new web-
based NECTAR, what medical research can do for them in terms of
participation in studies, the best available therapies, and nearby
advanced research centers.
STEWARDSHIP
We realize that to advance the NIH scientific agenda, our
management and administration must be effective, efficient and
productive. By introducing new information technology and business
systems and streamlining governance structures, we are placing
continuous improvement of management and administrative functions at
the forefront of our agency priorities. Let me highlight a few of our
efforts.
NIH is making rapid progress to modernize its business and
financial systems. An agency-wide information technology system, known
as the New Business System (NBS), is integrating such processes as
acquisitions, travel, property, and financial management. This effort
will reduce the cost and complexity of doing business, enhance the
level of service, and improve management controls.
NIH is also improving its peer review system, which is recognized
as the cornerstone of NIH's success. The NIH Center for Scientific
Review (CSR), the focal point of the NIH peer review system, reviews
about 70 percent of the grant applications submitted to NIH. In fiscal
year 2003, CSR received a record-breaking 66,000 grant applications.
CSR is in the final stages of crafting new and more flexible review
panels organized into 24 scientifically-related clusters. NIH is also
incorporating new technologies into the review process through the
electronic Research Administration (eRA). The goal is to implement an
end-to-end electronic grants administration for NIH research award
mechanisms that could reduce the waiting period from submission of an
application to a grant award by more than two months--from 9 to 10
months down to 7 months.
Remarkably, because of improvements in productivity over the past
ten years, NIH funding has grown 141 percent, while our FTEs have
increased by only 16 percent.
The NIH also realizes the need for a more efficient means of trans-
NIH coordination. To streamline decision making, we reduced the
plethora of NIH administrative committees down to a trans-NIH Steering
Committee and 5 working groups. Additionally, as we discussed when I
met with the subcommittee in January, all our conflict of interest
policies and procedures are under review both to ensure that they meet
the highest standards and, most importantly, to preserve the public's
trust in the NIH. I will soon receive the report of a Blue Ribbon Panel
I created to advise NIH on what changes they think we should make. I
will inform you about their conclusions, and mine, once they complete
their work next month.
BUDGET
The discretionary fiscal year 2005 budget request for the NIH is
$28,607 million ($28,527 million from this subcommittee and $80 million
from the VA/HUD subcommittee), an increase of $729 million or 2.6
percent over the fiscal year 2004 Enacted Level. In addition, $47.4
million is included in the budget authority request of the Public
Health and Social Services Emergency Fund (PHSSEF), for NIH research in
radiological/nuclear countermeasures, and $150 million in mandatory
funds was previously appropriated for the Special Type 1 Diabetes
Initiative, bringing NIH's program level total to $28,805 million, or a
2.7 percent increase. The budget increases funding for the NIH Roadmap
(+$109 million), obesity research (+$40 million), which will thus grow
by 10 percent from $400 million in 2004, and biodefense research (+$74
million), an increase of 4.5 percent over fiscal year 2004.
CONCLUSION
In conclusion, I want to reemphasize the NIH commitment to help
improve the health of the American people. Although we have had great
success in changing acute lethal diseases like AIDS and many cancers
and childhood diseases into chronic manageable diseases, there are many
challenges ahead. Life expectancy has increased and the diseases of
aging and the aging population have become major priorities.
With a shift from acute to chronic diseases, health disparities and
pediatric diseases also present challenges, as do emerging and re-
emerging diseases, such as SARS. We are confident, as the committee has
shown it is, that medical research will make a critical difference in
the lives of all Americans.
As the NIH director, I fully understand and embrace my role as the
steward of our Nation's investment in medical discovery. And I remain
vigilant to ensure that these precious resources--including over
212,000 scientists working at 2,800 institutions in the United States
and overseas and the 5,000 scientists at the NIH itself--are used
wisely and efficiently and produce not only new knowledge but also
tangible benefits that touch the lives of every individual who reaches
out for our help.
BUILDINGS AND FACILITIES PROGRAM
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the Buildings and Facilities (B&F)
Program for fiscal year 2005, a sum of $99,500,000.
ROLE IN THE RESEARCH MISSION
State-of-the-science research and support facilities are a vital
part of the research enterprise. The National Institutes of Health's
(NIH) Buildings and Facilities (B&F) program designs, constructs,
repairs and improves the agency's portfolio of laboratory, clinical,
animal, administrative and support facilities at its six installations
in three states. These facilities house researchers from the NIH
Institutes' and Centers' (ICs) intramural basic, translational, and
clinical research programs; the NIH leadership, and various programs
that support agency operations. The fiscal year 2005 B&F budget request
supports critically needed and timely investments to keep the agency's
facilities and supporting physical infrastructure healthy, safe,
secure, and research ready.
The B&F budget request is the product of a comprehensive, corporate
capital facilities planning process. This process begins with extensive
consultation across the research community and the NIH's professional
facilities staff. It works through the Facilities Working Group, an
advisory committee to the NIH Steering Committee and the HHS Capital
Investment Review Board. The budget request is the current year plan in
a rolling five-year facilities plan. Through this process, the real and
insistent program demand for more effective and efficient facilities
designed to support current and emerging investigative techniques,
technologies, and tools is integrated with, and balanced against, the
need to repair, renovate, and improve the existing building stock to
keep it in service and to optimize its utility.
The fiscal year 2005 request provides the necessary funding support
for the ongoing safety, renovation and repair, and related projects
that are vital to proper stewardship of the entire portfolio. It
provides funds to continue the functional integration of the clinical
research components of the existing Building 10 with the new Mark O.
Hatfield Clinical Research Center (CRC). Additionally, the request
includes funds to: complete the design of the Animal Research Center
(ARC) on the Bethesda campus; complete the creation of a security
buffer around the Rocky Mountain Laboratories (RML), in Hamilton, MT;
and to add another chiller to the NIH's Bethesda campus central utility
system that is needed to meet current and anticipated cooling demands.
The fiscal year 2005 B&F budget request is organized among five
broad Program Activities: Construction, Essential Safety and Regulatory
Compliance, Repairs and Improvements, Renovations, and Equipment/
Systems. The fiscal year 2005 request provides funds for specific
projects in each of the program areas. The projects and programs
enumerated are the end result of the aforementioned NIH facilities
planning process and are the NIH's capital facility priorities for
fiscal year 2005.
FISCAL YEAR 2005 BUDGET SUMMARY
The fiscal year 2005 budget request for Buildings and Facilities is
$99.5 million. The B&F request contains $16.5 million for Construction,
including $5 million to complete the design of an Animal Research
Center; $9.5 million to complete the creation of a security buffer
around the Rocky Mountain Laboratories (RML) in Hamilton, MT; and $2
million for concept development studies of projects proposed in the
facilities plan.
There is a total of $6 million for Essential Safety and Regulatory
Compliance programs composed of $0.5 million for the phased removal of
asbestos from NIH buildings; $2 million for the continuing upgrade of
fire and life safety deficiencies of NIH buildings; $1 million to
systematically remove existing barriers to persons with disabilities
from the interior of NIH buildings; $0.5 million to address indoor air
quality concerns and requirements at NIH facilities; and $2 million for
the continued support of the rehabilitation of animal research
facilities. In addition, the fiscal year 2005 request includes $59.2
million in Repairs and Improvements for the continuing program of
repairs, improvements, and maintenance that is the vital means of
maintaining the complex research facilities infrastructure of the NIH.
The request includes $10.8 million in Renovations to complete the
Building 10 Transition Program. Finally, the request includes $7
million in Equipment/Systems for the Chiller 27 project.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Paul A. Sieving
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Eye Institute (NEI) for
fiscal year 2005. This budget includes $671.6 million, an increase of
$18.8 million over the fiscal year 2004 enacted level of $652.7 million
comparable for transfers proposed in the President's request. As the
Director of the NEI, it is my privilege to report on the progress
laboratory and clinical scientists are making in combating blindness
and visual impairment and about the unique opportunities that exist in
the field of vision research.
RETINAL DISEASES
Retinal diseases are a diverse set of sight-threatening conditions
that include age-related macular degeneration, diabetic retinopathy,
retinopathy of prematurity, retinitis pigmentosa, Usher's syndrome,
ocular albinism, retinal detachment, uveitis (inflammation), and cancer
(choroidal melanoma and retinoblastoma). One of the most tragic retinal
diseases, retinopathy of prematurity (ROP), causes severe vision loss
in premature, low-birthweight infants. ROP is characterized by
excessive growth of abnormal blood vessels in the back of the eye that
often hemorrhage and scar the retina. This year, results from an NEI-
funded clinical trial, called the Early Treatment of Retinopathy of
Prematurity (ETROP), established that early treatment, based on newly
developed diagnostic criteria, improves visual outcomes in infants at
the greatest risk of developing ROP. The ETROP study also found that
these new diagnostic criteria were helpful in select patient subgroups
that may not ultimately develop ROP. For these infants, careful
observation was found to be the best approach. Results from ETROP will
greatly improve visual outcomes for children with ROP.
Age-related macular degeneration (AMD) is a leading cause of
blindness in patients over age 60 in the United States and is a major
health problem in most other developed countries. More than 9 million
Americans have some degree of AMD (Archives of Ophthalmology, In
Press). Based on the results of an NEI-funded clinical trial, the Age-
Related Eye Diseases Study (AREDS), 1.3 million of these people would
develop advanced AMD if no treatment were given to reduce their risk.
If these people at risk for development of advanced AMD received the
supplements (vitamins C, E, beta-carotene, and zinc) used in AREDS,
more than 300,000 of them would avoid advanced AMD and any associated
vision loss over the next five years. Delaying the advance of a disease
in older-age populations is an essential strategy to reduce the burden
and incidence of disease.
Uveitis is an autoimmune inflammatory disease of the eye that
accounts for up to 10 percent of blindness in the United States
(Ophthalmology 2004; 111:491-500). In collaboration with researchers at
the National Cancer Institute, NEI intramural scientists have reported
promising results with the use of a monoclonal antibody (daclizumab) in
the long term treatment of patients with uveitis. This new therapy
seems to have many fewer side effects than existing immunosuppressive
therapies, leading to an improved quality of life. Planning is underway
to begin a Phase III study to evaluate the full potential of this
therapy.
CORNEAL DISEASES
The cornea is the transparent tissue at the front of the eye.
Corneal disease and injuries are the leading cause of visits to eyecare
clinicians, and are some of the most painful ocular disorders. In
addition, approximately 25 percent of Americans have a refractive error
known as myopia or nearsightedness that requires correction to achieve
sharp vision; many others are far-sighted or have astigmatism.
NEI intramural scientists found that serum albumin represents up to
13 percent of the total water-soluble protein of the mouse cornea.
Humans also have abundant serum albumin in the corneal stroma. Because
the serum albumin accumulates in the corneal stroma by diffusion from
the blood supply surrounding the cornea, it may provide an improved
route of drug delivery to the cornea. Conjugating serum albumin to the
drug of choice and injecting the conjugate into the blood stream will
not only direct the drug within the cornea, but extend its half-life
within this tissue. Future research will evaluate the usefulness of
serum albumin as a drug carrier to treat corneal disorders.
NEI intramural scientists recently identified an enzyme called CDK5
that regulates corneal epithelial cell adhesion and migration. Using a
model wound healing system, these researchers found that the rate of
wound closure was significantly retarded in cells with too much CDK5
and accelerated in cells in which the CDK5 was inactivated.
Continuation of this line of research may provide the means to promote
rapid healing of corneal tissues that have been damaged by disease or
injury.
CATARACT
Cataract, an opacity of the lens of the eye, interferes with vision
and is the leading cause of blindness in developing countries. In the
United States, cataract is also a major public health problem. The
economic burden of cataract will worsen significantly in coming decades
as the American population ages.
Age-related cataract formation is believed to result from the
complex effects of aging on normal physiological processes. It has long
been recognized that lens transparency is a function of a very high
concentration of soluble proteins, the crystallins, within the
specialized lens fiber cell. In the lens, a-crystallin has a dual
function: it accumulates in fiber cells in high concentrations to
produce the high refractive index needed for transparency, and it
functions as a molecular chaperone to protect against clouding of the
lens due to protein aggregation. For some time, scientists have
attempted to understand how a-crystallin can continue to perform its
chaperone functions over a range of stress conditions encountered by
the lens during a lifetime. New data suggest that under low stress, a-
crystallin is maintained in a multi-subunit complex. Under conditions
of high stress, a-crystallin breaks into smaller sub-units that can
protect the clarity of the lens from protein aggregation. It has been
hypothesized that this chaperone function decreases with age and leaves
the lens more vulnerable to stressful conditions. Improving our
understanding of this protective role of a-crystallin may one day lead
to the means to prevent cataract.
GLAUCOMA AND OPTIC NEUROPATHIES
Glaucoma is a group of eye disorders that share a distinct type of
optic nerve damage, which can lead to blindness. Elevated intraocular
pressure (IOP) is frequently, but not always, associated with glaucoma.
Glaucoma is a major public health problem and is a leading cause of
blindness in African Americans (Archives of Ophthalmology, In Press).
A hallmark of glaucoma is the death of retinal ganglion cells (RGC)
in the retina, which can lead to catastrophic vision loss. Previous NEI
studies have found evidence that elevated IOP deprives RGCs of brain-
derived neurotrophic factor (BDNF), an endogenous protein that is
crucial to RGC survival. Ocular injections of BDNF in rodent models of
glaucoma have improved RGC survival. However, due to the relatively
short half-life of this protein, the need for frequent ocular
injections would not bode well in treating a chronic disease like
glaucoma. To overcome this hurdle, NEI-supported researchers recently
used gene therapy in rodent models of glaucoma to transfect RGCs with
the gene that encodes BDNF, providing a lasting and direct supply of
this essential protein. Ongoing NEI-supported laboratory work is
evaluating whether gene therapy with BDNF provides long-term benefit
and whether gene delivery with other neurotrophic agents, alone or in
combination with BDNF, improves RGC survival.
STRABISMUS, AMBLYOPIA AND VISUAL PROCESSING
Developmental disorders such as strabismus (misalignment of the
eyes) and amblyopia (commonly known as ``lazy eye'') are among the most
common eye conditions that affect the vision of children. In addition,
more than three million Americans suffer from visual processing
disorders not correctable by glasses or contact lenses (Archives of
Ophthalmology 1990; 108:286-290).
Patching the stronger eye has been a mainstay of amblyopia therapy.
Unfortunately, there is no specific patching regimen that is widely
accepted for treating the disease. To address the clinical issue of the
optimal number of patching hours for moderate amblyopia, an NEI-
supported clinical trial compared daily patching of two hours versus
six hours for children with moderate amblyopia. Results from this
clinical trial revealed that patching the unaffected eye of children
with moderate amblyopia for only two hours daily is as effective as
patching the eye for six hours. This finding should improve treatment
compliance as patching can be a socially stigmatizing and uncomfortable
practice for young children.
TECHNOLOGICAL INNOVATIONS
The marriage of computer technology and medical science is creating
advances in treating even the most intractable diseases. In one such
union, specially designed computer chips implanted in the eye may one
day make it possible to partially restore visual function to the blind.
Ocular neuro-degenerative diseases such as retinitis pigmentosa (RP)
and macular degeneration damage and destroy the light-sensitive
photoreceptor cells in the retina. The microelectronic retinal
prosthesis, a device developed by NEI-supported researchers, mimics the
function of photoreceptor nerve cells by turning light into electric
signals. In a recently published study, a 74 year-old patient blind
with RP was able to see spots of light, detect motion, and recognize
simple shapes. Although preliminary, these results are a promising
first step in realizing a prosthetic device that can restore ambulatory
vision to patients with retinal degenerative diseases, which are a
major cause of vision loss in this country.
PROGRAM INITIATIVES
The rapid progress in areas of gene discovery and bioinformatics
has created the need for enhanced cooperation and coordination among
groups that provide genetic diagnostic information to the clinician and
patient, store and provide DNA specimens to researchers, and maintain
data banks of genotype-phenotype information. Such groups are
underrepresented in the area of human ocular disease. The purpose of
this initiative is to explore the establishment of a national central
registry and molecular database of securely coded information from a
large number of people with ocular diseases caused by genetic
mutations. Information will be provided through a network of
cooperating groups who provide genetic and diagnostic services to
patients and clinicians. Such a registry and database will be of great
value in advancing research for these important diseases.
Clinician scientists will play a major role in translating
laboratory findings into safe and effective therapies. However, the
vision research community has raised concerns about the future of
clinician scientists. Declining clinical revenues are making it
increasingly difficult for clinicians to find time away from the
examination room to get the training they need. However, many of the
investigational therapies now being contemplated will be translated by
the next generation of clinician scientists. We need to make sure that
current clinician scientists have a capable next generation to pass the
torch to.
In addition to its existing extramural training and career
development grant programs, the NEI is working to increase the ranks of
the clinician scientist through a new intramural clinician scientist
training program at the NEI. The Clinician Scientist Development
Program is designed for board eligible/certified clinicians who seek to
develop an independent research program that integrates the field of
vision research with the clinical study of patients with ocular disease
or disorders.
The NEI recently published its forward looking National Plan for
Eye and Vision Research. The NEI's ongoing planning process involves
the assessment of important areas of progress in eye and vision
research and the development of new goals and objectives that address
outstanding needs and opportunities for additional progress. The
National Plan can be accessed through the NEI website at: http://
www.nei.nih.gov/strategicplanning.
NIH ROADMAP
The NIH Roadmap provides a framework for the priorities the NIH as
a whole must address in order to optimize its entire research
portfolio. The NEI is committed to the initiatives of the Roadmap and
is working to meet its goals. I would like to highlight NEI's
involvement in two Roadmap Initiatives: ``Nanomedicine'' and ``Re-
Engineering the Clinical Research Enterprise.''
The NEI and the National Human Genome Research Institute are
heading an NIH committee charged with implementing the Nanomedicine
Roadmap Initiative. Nanotechnology originated in the fields of
engineering and physics and refers to the research and development of
materials and devices at the atomic, molecular or macromolecular
levels. Nanomedicine integrates nanotechnology with biomolecular
processes. The long-term goal of the Nanomedicine Roadmap Initiative is
the development of therapeutic nanotechnology interventions for medical
diagnosis and the treatment of disease. To meet these goals we are
establishing a process to solicit ideas and concepts germane to the
development of Nanomedicine Development Centers.
Nanomedicine Development Centers will be designed to achieve an
understanding of biological systems at the nanomolecular level.
Over the past decade NEI-supported laboratory research has given
rise to an unprecedented number of promising, pre-clinical therapies
for eye disease. NEI's continued success depends on building the
clinical infrastructure for translational medicine. Consonant with the
NIH Roadmap initiative ``Re-engineering the Clinical Research
Enterprise'' the NEI is creating cooperative clinical research groups
that will enhance and expand clinical trial infrastructure. Over the
last year, the NEI implemented the Diabetic Retinopathy Clinical
Research Network. More than 70 clinical centers with the capability to
participate in the clinical trials network have been identified. This
network joins the highly effective Pediatric Eye Disease Investigator
Group as models for future clinical networks the NEI plans to build.
Mr. Chairman that concludes my prepared statement. I would be
pleased to respond to any questions you or other members of the
committee may have.
______
Prepared Statement of Dr. John Ruffin
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Center on Minority
Health and Health Disparities (NCMHD) for fiscal year 2005, a sum of
$196,780,000, which represents an increase of $5,324,000 over the
comparable fiscal year 2004 appropriation.
A STRATEGIC APPROACH TO ELIMINATE HEALTH DISPARITIES
Unprecedented scientific advances in biomedical research over the
last several decades dramatically improved public health. However,
racial and ethnic minorities and other populations that experience
disparities in health status have not benefitted equally from our
Nation's progress in scientific discovery.
The NIH supports a comprehensive research program to better
understand why a broad spectrum of diseases disproportionately impact
racial and ethnic minorities and the urban and rural poor. No other
scientific area so thoroughly transcends so many diverse areas of
science and involves all of the NIH Institutes and Centers (ICs).
The NCMHD plays a key role in framing the NIH health disparities
research agenda by conducting and supporting basic, clinical, social
sciences, and behavioral health disparities research; developing
research infrastructure and training programs; reaching out to and
disseminating health information to minority and other health disparity
populations; stimulating scientific programs within the NIH ICs to
uncover the causes of health disparities and eliminate their impact on
society; and developing and updating the NIH Health Disparities
Strategic Plan.
This past year, the NCMHD, in collaboration with the NIH Director,
every NIH IC, and the National Advisory Council on Minority Health and
Health Disparities, completed the first comprehensive NIH Health
Disparities Strategic Plan, based on scientific priorities and
opportunities that will lead to new therapies and prevention strategies
that will ultimately eliminate health disparities in America. This
evolving plan will guide future NIH health disparities research
efforts.
INNOVATIVE EFFORTS TO COMBAT HEALTH DISPARITIES
The NCMHD has accomplished much since its creation. Today, the
NCMHD has 60 Health Disparities Centers of Excellence spread across the
nation. These Centers of Excellence, now located in 23 states, the
District of Columbia, and Puerto Rico, support health disparities
research, research training, and community involvement to identify
factors that contribute to health disparities and to develop and
implement new diagnostic, treatment, and prevention strategies.
The NCMHD addresses the national need to develop a diverse, strong,
and a culturally competent scientific workforce by eliminating barriers
that prevent racial and ethnic minority students and students from
disadvantaged backgrounds from pursuing research careers. Currently,
the NCMHD supports about 300 researchers from 38 states through its two
Loan Repayment Programs, which help to level the playing field and make
it possible for under represented individuals to enter the scientific,
technological, and engineering workforce. These ``Health Disparities
Ambassadors'' are key to creating the culturally competent health
disparities and clinical research workforce of the future.
The NCMHD has also created a one-of-a-kind Research Endowment
Program. Unique at the NIH, this program addresses the national need to
build research and training capacity in institutions that make
significant investments in the education and training of minority and
disadvantaged individuals. This program is making it possible for 13
institutions located in 11 states and Puerto Rico to establish health
disparities endowed chairs and programs, enhance student recruitment
efforts, provide merit-based scholarships, recruit and retain faculty,
develop innovative instruction delivery systems in minority and health
disparities research areas, and access emerging technologies.
The NCMHD Research Infrastructure in Minority Institutions Program,
born out of a partnership between the National Center of Research
Resources and the Office of Research on Minority Health, (the
predecessor to the NCMHD) is making it possible for institutions to
target research efforts on health disparities that exist in the
Southwest Border States; in rural communities, such as the Appalachia
Region, the Mississippi Delta, and the Frontier States; and in urban
centers of the nation. Currently, 11 institutions in eight states
benefit from this program.
In addition to using its core programs, the NCMHD strategy to
eliminate health disparities also includes leveraging NIH dollars and
expertise by creating partnerships with the NIH ICs and other agencies
within the Department of Health and Human Services to fund health
disparities research, training, and outreach programs. Over the past
two years alone, the NCMHD forged many new partnerships, supporting
more than 400 research projects to combat health disparities in our
nation.
CLOSING THE HEALTH DISPARITY GAP
Racial and ethnic minorities and other health disparity populations
experience a disproportionate burden of illness, disability, and
premature death due to cancer, cardiovascular disease and stroke,
diabetes, HIV/AIDS, infectious diseases, infant mortality, and other
diseases. The Department of Health and Human Services, through its
``Closing the Gap Initiative,'' designates these areas as major
research priorities. NCMHD programs focus on these priorities and many
others. The following initiatives represent a small sampling of the
richness and diversity of NCMHD activities.
Cancer
Cancer deaths vary by gender, race, and ethnicity. Certain racial
and ethnic groups have lower survival rates than whites for most
cancers. Colorectal cancer rates among Alaska Natives are higher than
the national average and Asian Americans suffer disproportionately from
stomach and liver cancers. African American men have the highest rates
of colon, rectum, prostate, and lung cancers (Healthy People 2010).
NCMHD Health Disparities Centers of Excellence in 12 states across
the nation are bringing to bear their state-of-the-art research and
outreach programs to eliminate the impact of cancer on diverse
populations. These efforts take place in Alabama, Arizona, California,
Colorado, Georgia, Maryland, Mississippi, New York, Pennsylvania,
Tennessee, Texas, and Virginia. One example of this intense effort is
the American Indian and Alaska Native Health Disparities Center in
Colorado, which conducts cancer research to address the needs of Native
American and Alaska Native populations.
The NCMHD Research Infrastructure in Minority Institutions program,
which focuses on building research capacity at minority serving
institutions, also addresses cancer health disparities. The Charles R.
Drew University is working to improve the detection and
characterization of brain tumors, and researchers at San Francisco
University are examining the impact of social support, spirituality,
and depression on quality of life among breast cancer survivors from
diverse populations.
Forty-five Health Disparities Ambassadors supported by our Loan
Repayment programs have also set their sights on combating cancer
health disparities in 17 states including Alabama, California,
Colorado, Georgia, Illinois, Kansas, Massachusetts, Maryland, Michigan,
Minnesota, North Carolina, New York, Pennsylvania, Tennessee, Texas,
Virginia, Wisconsin, and in the District of Columbia. Some of the
exciting work taking place under this program includes a community-
based health promotion project to prevent cervical cancer in
Vietnamese-American women; research studies on racial differences and
barriers in obtaining breast, cervical, and colon cancer screening; and
a population-based study that examines the variation in outcomes of
colorectal cancer between African Americans and whites.
Collaboration with the other NIH Institutes and Centers has allowed
the NCMHD to extend the reach of its scientific expertise to tackle
cancer health disparities in rural populations. For example, the
Appalachia Cancer Network, cosponsored by the NCMHD and the National
Cancer Institute, addresses cancer in rural and medically underserved
Appalachian populations in West Virginia, Kentucky, Tennessee,
Virginia, Ohio, Pennsylvania, Maryland, and New York. The goal of this
network is to reduce cancer incidence and mortality and to prevent
future increases; to increase cancer survival; and to stimulate greater
coordination and participation among regional, state, and community
cancer control networks throughout Appalachia.
Cardiovascular Disease & Stroke
Cardiovascular disease takes a heavy toll on certain populations.
Heart disease rates have been consistently higher in the African
American population than in whites (Healthy People 2010). Data on
stroke risk factors are sparse for most racial and ethnic populations,
except for African Americans whose stroke deaths, when adjusted for
age, are almost 80 percent higher than in whites (Healthy People 2010).
Today, 13 NCMHD Health Disparities Centers of Excellence, located
in nine states across the nation including California, Georgia, Hawaii,
Maryland, Mississippi, North Carolina, New York, Pennsylvania, and
Texas focus on eliminating disparities due to cardiovascular disease.
Three Health Disparities Centers of Excellence in Georgia, Mississippi,
and New York focus on stroke research. The NCMHD also supports 20
Health Disparities Ambassadors spread across 11 states, including
California, Florida, Illinois, Indiana, Massachusetts, Michigan, New
Hampshire, New Jersey, New York, Ohio, and Texas, who have set their
sights on eliminating health disparities due to cardiovascular disease.
The NCMHD Health Disparities Center of Excellence at Jackson State
University in Jackson, Mississippi is built on a partnership with the
University of Mississippi Medical Center, the University of Pittsburgh,
and the Jackson Medical Mall Foundation. This Center's research agenda
focuses on cardiovascular disease, stroke, and cancer in the African
American population in Mississippi.
The NCMHD also partners with its fellow NIH ICs, in the battle
against cardiovascular disease and stroke disparities. The NCMHD
partners with the National Heart, Lung, and Blood Institute to support
the Jackson Heart Study. This study evaluates the environmental and
genetic factors contributing to the disproportionate incidence of
cardiovascular disease in African American men and women living in
Mississippi. To date, almost 5,000 participants have benefitted from
the program by visiting the clinic, with an average of 25 participants
per week.
The NCMHD and the National Institute of Neurological Disorders and
Stroke partner to support two Specialized Neuroscience Research
Programs at the Morehouse School of Medicine and at the University of
Texas at San Antonio. This funding allows institutions to develop
state-of-the-art neuroscience research programs; strengthen
collaborations and resource-sharing between minority medical and
graduate schools, community-based organizations, and leading
neuroscience laboratories; expand training opportunities for minority
students to access and prepare for careers in neuroscience research;
and build new stroke research capacity.
Diabetes
Certain communities, including Hispanics, American Indians, African
Americans, and certain Pacific Islanders and Asian populations, as well
as economically disadvantaged and older people suffer
disproportionately from diabetes (Healthy People 2010). Diabetes is the
target of 27 Health Disparities Centers of Excellence in 17 states
including Alabama, Arizona, California, Colorado, Georgia, Hawaii,
Illinois, New York, North Carolina, North Dakota, Maryland,
Mississippi, Oklahoma, Pennsylvania, South Carolina, Texas, and
Wisconsin, as well as the District of Columbia. These programs include
the University of Hawaii at Manoa, where efforts are underway to reduce
and eliminate the major complications of diabetes in Pacific Islanders.
The University of Pennsylvania is developing behavioral strategies for
reducing obesity, a major factor contributing to diabetes in Latino and
African American communities.
The NCMHD has also deployed 15 Health Disparities Ambassadors to 10
states, including Alabama, California, Florida, Georgia, Illinois,
Massachusetts, New Hampshire, New York, Texas, and Virginia in the
effort to eliminate diabetes-related health disparities. These
individuals are conducting several important projects including
reducing obesity in diabetic African American women in the state of
Georgia and conducting educational interventions to prevent type 2
diabetes in middle school children in Alabama. Under the NCMHD Research
Endowment program, Xavier University of Louisiana is increasing the
diabetes research capability of its College of Pharmacy, promoting
health disparities research, and increasing the pool of well educated
under represented minorities who pursue advanced education in
biomedical and behavioral research.
New NCMHD partnerships are also playing a significant role in
eliminating diabetes health disparities. The NCMHD and the Indian
Health Service recently formed a partnership to develop the Tribal
Epidemiology Centers Program to address and eliminate health
disparities, including diabetes disparities, experienced by American
Indians and Alaska Natives. Recent NCMHD support enabled the creation
of a new Northern Plains Tribal Epidemiology Center in Rapid City,
South Dakota, continued funding for the other six existing EpiCenters,
and the development of a summer training institute for Indian Health
professionals. The funding will assist the EpiCenters to carry out
their training program for local health staff, and expand their
outreach activities to include a community-based research training
program.
HIV/AIDS
The disproportionate impact of HIV/AIDS on certain populations
underscores the importance of sustained research and prevention
efforts. In 2002, the AIDS diagnosis rate among African Americans was
almost 11 times the rate among whites. African American women had a 23-
times greater diagnosis rate than white women. African American men had
almost a nine-times greater rate of AIDS diagnosis than white men.
(Centers for Disease Control and Prevention Division of HIV/AIDS
Prevention 2003). In 2000, the AIDS incidence among Hispanics was 22.5
per 100,000 population, more then three times the rate for whites
(Centers for Disease Control and Prevention Division of HIV/AIDS
Prevention 2002:1).
In its fight against HIV/AIDS health disparities, the NCMHD
partners with the Centers for Disease Control and Prevention to support
the Racial and Ethnic Approaches to Community Health (REACH) Program.
REACH serves African American, Asian American, Pacific Islander,
Hispanic American, American Indian, and Alaskan Native populations at
increased risk for HIV/AIDS, cardiovascular disease, breast and
cervical cancer, diabetes and infant mortality. REACH develops,
implements, and evaluates innovative community level intervention
demonstrations that could be effective in eliminating health
disparities by 2010.
With the Agency for Healthcare Research and Quality, the NCMHD
supports the EXCEED Program to examine the underlying causes and
contributing factors for racial and ethnic disparities in health care
and to identify and implement strategies for reducing and eliminating
those disparities. Under this initiative, the Medical University of
South Carolina is examining strategies to address HIV/AIDS disparities
in health status between African Americans and whites, and the Baylor
College of Medicine is assessing the extent to which problems in
doctor-patient communication contribute to racial and ethnic
disparities in health care use.
Infant Mortality
In recent years, infant mortality rates in the United States have
steadily declined; yet the rate of Sudden Infant Death Syndrome among
African Americans is still twice that of whites. African American women
continue to be three to four times more likely than white women to die
of pregnancy-related complications. Hispanic women are less likely than
whites to enter into early prenatal care. Fetal Alcohol Syndrome
disproportionately impacts American Indian, Alaska Native, and African
American babies. (Healthy People 2010).
The NCMHD has Health Disparities Centers of Excellence in six
states including Alabama, Florida, Georgia, Texas, Iowa, and Wisconsin
that focus their efforts to improve the health of mothers and their
infants. One of these, the ``Mexican-American Women's Health Project
Center'' at the University of Texas, El Paso, partners with established
Hispanic health disparities researchers at the University of Arizona.
Their research efforts focus on modifying behaviors of Mexican-American
women relating to alcohol use; maternal health and nutrition; smoking
cessation; and the pursuit of recommended Pap and HPV screening tests.
Another Center at the University of Northern Iowa focuses on maternal
and child health disparities to address the special health needs of
Iowa's minority groups, which include urban African Americans, members
of the Meskwaki Indian Tribe, rural families, growing populations of
Latino and East African immigrants, and refugees from Bosnia and the
former Soviet Union.
The NCMHD also supports six Health Disparities Ambassadors through
its Loan Repayment Programs, who are focusing their attention on infant
mortality health disparities. These efforts is take place in Florida,
Maryland, Michigan, Missouri, North Carolina, and Pennsylvania. Ongoing
efforts include evaluating the link between sexually transmitted
diseases and infant mortality; determining leading health indicators
for women and girls; and creating logic models for maternal, child, and
family health programs.
RURAL HEALTH
Another top priority of the NCMHD is improving rural health across
the nation. In pursuit of this goal, the NCMHD established an
innovative Health Disparities Center of Excellence partnership between
Clemson University and Voorhees College, a Historically Black
Institution in South Carolina. This partnership will build capacity for
research, training, and outreach to address health disparities in rural
Hispanic and African American communities in South Carolina. The
Tuskegee University and the University of Alabama, Tuscaloosa Health
Disparities Center of Excellence partnership, in conjunction with the
University of Alabama Institute for Rural Health Research and community
organizations, focuses on adult immunization, infant mortality, cancer,
and diabetes.
Over the past year, the NCMHD also created opportunities to include
the expertise of other NIH ICs in addressing the needs of rural
communities, forming 16 new rural health partnerships with the NCI,
NHLBI, NIAAA, NIDA, NIEHS, NIMH, and the NINR. Examples of these new
projects include the Appalachia Cancer Network; the Deep South Network
for Cancer Control; the Rural Caregiver Telehealth Intervention Trial;
and studies on the effects of alcohol and violence on rural women;
coronary artery disease in Alaska Natives; migrant worker health and
the environment; mental health treatment for rural Mexican Americans,
African Americans, women, and the poor; cardiovascular health training
and outreach in Latino communities; and substance abuse among Ojibwe
children and youth.
CONCLUSION
The diversity of the American population is one of the greatest
assets of the nation. One of the greatest challenges facing the nation
is reducing and eliminating the profound disparity in health status
that exists for many of its populations. Without decisive action now,
the health challenges of the 21st century will expand along with the
increasing number of racial and ethnic minorities, inhabitants of rural
areas, and low socioeconomic populations.
The NCMHD will continue to combat health disparities through our
flagship programs. We will explore new opportunities to support
academic development for the health disparity researchers of tomorrow.
We will seek to create innovative programs to serve as a bridge between
NCMHD capacity building programs and an investigator's first
independent research effort. Cognizant of the value of engaging
communities in the elimination of health disparities, we will lead
efforts to conduct effective community-based outreach and research to
our numerous constituents. We will continue our legacy of creating and
nurturing partnerships to further increase the reach of our activities
to eliminate health disparities and we will encourage our fellow NIH
ICs to join the core health disparities programs of the NCMHD. The NIH
Roadmap Initiative should also provide opportunities for the NCMHD
constituent populations and research community to participate in
interdisciplinary research, clinical research, and technology.
Our vision of the future is a collective one that is embodied in
the NIH Health Disparities Strategic Plan. With leadership, commitment,
and strong scientific partnerships the NIH can advance scientific
discovery to ensure the health of all Americans. Working together, we
can turn the vision of an America where all citizens have an equal
opportunity to live long, healthy, and productive lives into reality.
______
Prepared Statement of Dr. Judith L. Vaitukaitis
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Center for Research
Resources (NCRR) for fiscal year 2005, a sum of $1,094,141,000,
including support for AIDS research, which reflects a net decrease of
$84,815,000 over the comparable fiscal year 2004 appropriation, due
entirely to the phasing out of extramural construction projects for
fiscal year 2005.
It is a pleasure once again to have the opportunity to present the
accomplishments of NCRR-supported investigators and the future
directions for NCRR programs. As a component of the National Institutes
of Health, NCRR enables all lines of health-related discovery by
supporting the creation and development of critical research resources
and technologies. Because significant discoveries can be made at a
variety of levels--from molecules to patients, or even patient
populations NCRR supports a wide range of research resources across
several disciplines. These resources include state-of-the-art clinical
research environments, such as the nationwide network of General
Clinical Research Centers. The GCRCs facilitate clinical research and
protect the safety of participants in research. Each year more than
10,500 NIH-supported investigators conduct nearly 8,000 research
projects at the GCRCs, predominantly through more than a half million
outpatient research visits.
NCRR also supports research resources that develop and enhance
scientific access to advanced technologies, nonhuman models for the
study of human diseases, and career development and training. Because
of its trans-NIH focus, NCRR is well-positioned to facilitate research
by promoting the sharing of research tools and technologies as well as
providing the tools for research collaborations so that research teams
may address more complex research problems.
TECHNOLOGY AND INSTRUMENTATION
NCRR strives to ensure that neither the lack of research resources
nor technology development becomes rate-limiting for research. Two
Nobel Prize winners in 2003 can vouch for the importance of having
ready access to NCRR-supported resources. Dr. Roderick MacKinnon of
Rockefeller University, co-recipient of the Nobel Prize in Chemistry,
was honored for his groundbreaking studies of the structures and
functions of ion channels, which control the movement of electrically
charged atoms across cell membranes. Ion channel malfunctions can
trigger a host of human disorders, including irregular heart rhythms
and seizure disorders. Dr. MacKinnon noted that his award-winning
discoveries depended on having access to the scientific expertise and
advanced research instrumentation available at NCRR-supported resources
that specialize in mass spectrometry and crystallography of complex
molecules.
The challenge for NCRR is to keep pace with the biomedical
community's changing needs for research tools and to ensure that
tomorrow's research queries have tomorrow's critical instrumentation
and technologies in hand. The research resources and tools needed for
scientific investigations change dramatically over time as more complex
research queries are posed and require new technologies. Many research
tools now considered critical to understanding the cause of disease and
protecting the health of Americans were unheard of just a few years
ago. For instance, the Magnetic Resonance Imagers, or MRIs, now found
in hospitals and medical centers across the country were rare and
experimental less than 20 years ago. Dr. Paul Lauterbur of the
University of Illinois, Urbana-Champaign, depended on NCRR for many of
his investigations into magnetic resonance imaging. Dr. Lauterbur was
co-recipient of the Nobel Prize in Physiology or Medicine for his
studies that led to the development of MRI. From 1990 to 2000, Dr.
Lauterbur headed an NCRR-funded magnetic resonance research center,
which helped to facilitate the evolution of MRI into the invaluable
diagnostic and clinical research tool that it is today.
CLINICAL RESEARCH RESOURCES
Just as NCRR technology and instrumentation resources laid the
foundation for critical discovery in the basic and applied sciences,
NCRR also catalyzes clinical and patient-oriented research through the
network of GCRCs. In addition, NCRR develops and supplies investigators
with clinical-grade biomaterials, such as vectors for gene therapy and
human pancreatic islets for transplantation into patients with type 1
diabetes.
Research on rare diseases is one area where the GCRCs are ideally
positioned to catalyze clinical research. Rare disease research is
challenging in part because few patients with a particular rare disease
can be recruited from any one clinical center. The nationally
distributed network of the GCRCs makes them well-suited for enabling
multicenter studies of rare conditions. Therefore, NCRR has partnered
with the NIH Office of Rare Diseases and other groups to launch a
network of Rare Diseases Clinical Research Centers. The network
provides researchers with access to sufficient numbers of affected
patients for statistically meaningful studies. The network also
facilitates collaborations among scientists from multiple disciplines
and institutions.
To ensure the safety of human subjects participating in clinical
research projects, clinical investigators must adhere to Federal, state
and local regulations, policies, and guidelines. Yet these necessary
responsibilities place heavy demands on the time of already-busy
clinician investigators. To address this issue, NCRR established a new
GCRC staff position known as the Research Subject Advocate (RSA). The
RSA assists GCRC investigators, nurses, and staff to underscore the
safe and ethical conduct of clinical studies and represents the
interests of research participants. NCRR plans to extend and strengthen
the role of RSA in an approach that complements that undertaken by the
host institution.
HEALTH DISPARITIES
NCRR also supports clinical research studies on health disparities,
or diseases that disproportionately affect racial and ethnic minority
populations. NCRR has joined with the National Institute of Mental
Health to establish three Comprehensive Centers on Health Disparities.
These Centers will further develop the capacity of Research Centers in
Minority Institutions' (RCMI) medical schools to conduct basic and
clinical research in type 2 diabetes and cardiovascular disease, both
of which disproportionately affect minority populations. The Centers
will provide support to further develop the requisite research
infrastructure, recruit magnet clinical investigators, recruit and
develop promising junior faculty, and facilitate substantial
collaboration between the RCMI grantee institutions and more research-
intensive universities. NCRR also supports a Stroke Prevention and
Intervention Research Program that focuses on minorities, as well as a
mentored clinical research career development program to provide
clinical research training for doctoral and postdoctoral candidates in
minority institutions.
BIOINFORMATICS AND COMPUTER NETWORKS
Whether studying clinical manifestations of disease or the basic
biology of cells and tissues, today's biomedical researchers generate
vast data sets. This data deluge has increased scientific demand for
access to scaleable computation and modern management tools. A related
and equally important trend is the fact that biomedical research
projects are becoming broader in scope. For example, neuroscientists
now want to correlate brain images with events at cellular and
molecular levels, including gene expression. These broad research
projects require large multidisciplinary teams, gathered from
scientists distributed across the country.
To meet the challenges associated with these trends, NCRR supports
the development of bioinformatics tools, including the software
programs or algorithms that help scientists manage and analyze their
data. NCRR also is instrumental in the creation of high-performance
computer networks that link laboratories throughout the United States.
A few years ago, NCRR joined with the National Science Foundation,
Internet2, and investigators from several universities to establish the
Biomedical Informatics Research Network (BIRN). The BIRN provides the
tools for researchers to pool their data and to use federated databases
so that they can oversee the integrity of their data, use
bioinformatics tools for data mining, and visualize their data. In
fiscal year 2004, NCRR began expanding the number of BIRN sites in
order to establish a national infrastructure of bioinformatics tools
and provide access to scaleable computing that, in turn, is linked to a
nationally distributed network of modern imaging capabilities for
studies of degenerative brain disorders.
Other components of the BIRN network will link underserved
institutions, such as doctoral degree-granting minority institutions
and institutions in states that have received limited NIH research
funding because they include very few research trained investigators,
otherwise known as Institutional Development Award (IDeA) states. The
networks will foster collaborative research and help investigators
create a virtual critical mass of investigators. The BIRN also will
foster collaborations across institutions located at remote sites. NCRR
plans to establish a network for institutions with medical schools that
are associated with NCRR's Research Centers in Minority Institutions
(RCMI) Program. This electronic network will facilitate their
participation in large clinical trials and other research studies and
help define the factors contributing to health disparities among
minority populations and ways to overcome those factors.
In concert with other NIH components, NCRR participates in many NIH
Roadmap initiatives for example, development of a National Electronic
Clinical Trials and Research (NECTAR) network, which will form the
backbone for all clinical research networks. An important component of
NECTAR will be the standardization of patient data collection and
storage procedures, which will facilitate data sharing by
investigators. NCRR also supports other trans NIH Roadmap initiatives,
including the National Centers for Biomedical Computing, Exploratory
Centers for Interdisciplinary Research, and National Technology Centers
for Networks and Pathways.
PROTEOMICS
The availability of complete genomes for a variety of organisms
provides an important first step in understanding many complicated
biological questions, including the molecular basis for disease. The
next step in this process will be to develop technologies to quantitate
spatiotemporal differences in the levels of gene expression, assess
post-translational modifications of proteins, and characterize protein-
protein interactions in both healthy and diseased cells.
NCRR will support the development of the necessary technology and
infrastructure to advance the science of proteomics. An advanced
proteomics center will focus on multiple technologies, including
techniques for protein purification, structural techniques, mass
spectrometry, and DNA microarray instrumentation along with the
necessary bioinformatics.
CONCLUSION
I have today noted two important trends in biomedical research the
rapid accumulation of data and the broadening scope of research
studies. To these, I must add a third trend namely, the increasingly
collaborative nature of biomedical science. Some of today's most
pressing questions in biomedical science are so complex, so
multifaceted, that they cannot be addressed by a single investigator or
even a single research laboratory. In many cases, teams of scientists
with diverse skills and backgrounds are needed to get the job done.
It is my belief that this emphasis on interdisciplinary
collaborations, as evidenced by the multiple NIH Roadmap initiatives
related to this area, will bring about unprecedented gains in
biomedical science, and ultimately lead to improved health of all U.S.
citizens. Finally, as the research paradigm evolves toward greater
complexity, the infrastructure required to support that research must
evolve too.
I will be happy to respond to any questions you may have.
______
Prepared Statement of Dr. Duane Alexander
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2005 President's budget request for the National
Institute of Child Health and Human Development (NICHD). The fiscal
year 2005 budget includes $1,280.9 million, an increase of $39.1
million over the comparable fiscal year 2004 appropriation of $1,241.8
million.
The NIH Roadmap provides the schema to guide the NICHD in achieving
its programmatic and research goals.
Today I would like to share with you how the research supported by
this committee is improving the lives of children, mothers, adults and
families, and helping to reduce health disparities. The NICHD is
participating in the trans-NIH obesity initiative identifying how
primary care physicians can help children maintain a healthy weight.
ENCOURAGING HEALTHY BIRTH OUTCOMES
Preeclampsia is a condition that affects five out of every hundred
women who become pregnant. Preeclampsia can occur suddenly, and without
warning, causing women to develop dangerously high blood pressure. In
some cases, the condition may progress to eclampsia in which women
experience potentially fatal seizures. Infants born to mothers with
preeclampsia may be extremely small for their age or may be born
prematurely, putting them at risk for a variety of other birth
complications. Although a woman's high blood pressure and seizures can
be treated, the only cure for preeclampsia is delivery of the baby. In
a significant step toward treating preeclampsia, researchers have
identified substances in the blood that have the potential to predict
who will develop preeclampsia. This knowledge may help us treat women
before preeclampsia becomes a serious problem, for them and their
infant.
We have also intensified our research in the area of stillbirth, a
devastating occurrence that affects far too many families. Health care
providers use the term stillbirth to describe the loss of a fetus after
the 20th week of pregnancy. Stillbirth can occur before delivery or as
a result of complications during labor and delivery. In at least half
of all cases, researchers can find no cause for the pregnancy loss. We
hope to change that. The NICHD has established the Stillbirth
Collaborative Network, which consists of research centers in Texas,
Utah, Rhode Island, and Georgia. In each center, a team of specialists,
including obstetricians, nurses, statisticians, and even grief
counselors will seek to understand the causes of stillbirth and
eventually find ways to prevent these deaths.
One way to increase the chances of a healthy pregnancy and healthy
birth outcome is to avoid alcohol during pregnancy. Infants born to
mothers who drink heavily during pregnancy are known to be at risk for
mental retardation and birth defects. They are also at increased risk
for Sudden Infant Death Syndrome (SIDS). NICHD researchers have now
identified another reason that women should not consume alcohol during
pregnancy: exposure to alcohol before birth affects the developing
nervous system in the arms and legs.
Recently, scientists in NICHD's Maternal-Fetal Medicine Units
Network reported a breakthrough in reducing a major cause of infant
mortality and the subsequent long term health problems associated with
prematurity. The scientists, working collaboratively in 14 academic
health centers across the United States, demonstrated that progesterone
administered to women at risk for premature birth could significantly
reduce the likelihood of early delivery. This was a very significant
discovery and we were delighted that others recognized its importance.
A few weeks ago, Parade magazine identified this discovery as one of
the ten most significant health advances of the past year.
NEW FRAGILE X CENTERS TO DEVELOP TREATMENT OPTIONS
In 2003, the NICHD funded three new Fragile X research centers.
Teams of researchers at each of the centers located in North Carolina,
Texas, and Washington state are developing new ways to diagnose both
the mild and severe forms of the condition, as well as new treatments.
Fragile X syndrome is the most common genetically-inherited form of
mental retardation currently known. It occurs in 1 out of every 2,000
males and in 1 in 4,000 females. The syndrome is caused by a mutation
in a specific gene, known as FMR1, on the X chromosome. In its fully-
mutated form, the FMR1 gene interferes with normal development,
resulting in mental retardation. In a partially mutated form, the FMR1
gene can cause fragile X syndrome in the children of a parent who is a
carrier. Until recently, it was thought that carriers did not have any
symptoms. Researchers have learned that some people with a form of
fragile X have mild cognitive and emotional problems. In addition, some
female carriers are likely to undergo premature menopause. In older
male carriers, the fragile X is associated with a neurological
degenerative syndrome. Identifying a means to predict which carriers
will develop the symptoms could be a first step toward developing new
treatments for these often overlooked symptoms. The Fragile X Research
Centers are focusing their research on how the fragile X affects the
developing brain and nervous system, how the disorder progresses
throughout an individual's life span, and treatments that can improve
the behavior and mental functioning of people with fragile X syndrome.
IMPROVING TREATMENT FOR CRITICALLY ILL CHILDREN
Critical care medicine for children is an emerging field where, in
general, physicians continue to rely upon adult treatments that have
not yet been tested for effectiveness in a young population. To change
this situation, the NICHD will help establish a national pediatric
critical care research network to develop and evaluate treatments for
children with disabling conditions. The initiative will foster
collaborations among scientists in many different fields and will
support research such as the best approach to care for children with
brain injury, the most effective way to transition a critically ill
child from an acute care to a rehabilitation setting, and the care of
critically ill children in the event of a bioterrorism attack.
CUTTING OBESITY THROUGH RESEARCH AND PROGRAMS
The increase in overweight and obesity among adults and children is
a major public health concern. In fact, in a recent analysis of
international data, NICHD researchers documented that U.S. teenagers
were more overweight than youth in 14 other developed countries. Like
many other health conditions that affect adults, the antecedents of
adult obesity can be found in childhood. Young children who are
overweight are likely to be overweight as adults. There is no single
explanation for the increase in childhood overweight and there is no
single solution. However, we know we must devise successful
interventions that help children maintain a healthy weight. As part of
the trans-NIH initiative, the NICHD will lead a major effort to
determine whether a weight control program for children and youth led
by primary care physicians as part of a comprehensive community-based
effort can be successful. Currently, most weight management programs
are administered through specialty clinics. However, there is strong
evidence that an appropriate intervention by a physician can have a
significant impact on personal behaviors such as tobacco use. Effective
weight management programs in a primary care setting would be
accessible to large numbers of children and would minimize the
geographic, social, and economic barriers that commercial weight
management programs can impose.
We are also developing an exciting research-based program that
helps to teach young children the fundamentals of good nutrition and
physical activity as well as how to make sense of the messages that
appear in the media. Three years ago, this committee provided funds to
the NICHD and other health agencies to develop programs that encourage
young people to engage in healthy behaviors. In response to this
directive, the NICHD has developed ``Media Smart Youth,'' an after
school program for children between nine and 13 years of age. The
program focuses on good nutrition and physical activity. But it also
provides skills to young children to interpret the messages about food
and snacks they see on television, in magazines, and on the Internet.
As part of their activity, the children who take part in Media Smart
Youth develop messages about the importance of good nutrition and
physical activity for their peers. The program has been tested with
youth groups around the country. In fact, the children at P.S. 127 in
the Bronx who took part in this program developed a message about
physical activity for young people that appeared for 30 minutes on the
Panasonic ``jumbotron'' screen in Times Square.
HELPING YOUNG CHILDREN PREPARE FOR SCHOOL
The preschool years are crucial for learning language, social
skills, and developing the intellectual capabilities that set the stage
for later success in school. Yet, comparatively little is known about
how to help young children obtain the greatest benefit possible from
the preschool experience. In December 2003, NICHD joined with two other
HHS agencies and the Department of Education, and launched a five year
research initiative to find the best ways to help preschoolers at risk
for failure in school acquire the skills they need for school success.
The initiative provided $7.4 million in funding for the first year.
Eight projects were funded to test research-based approaches to
preschool curricula, Internet based approaches to training preschool
teachers, and the importance of parental involvement for preparing
children to enter school. Funds requested for fiscal year 2005 will
allow us to expand this effort by funding academic researchers and
small businesses to develop and produce more effective measurements of
outcomes from preschool interventions.
SIDS RESEARCH SUPPORTS PROGRAM OUTREACH
We have known for more than 10 years that placing infants on their
backs to sleep reduces their risk of Sudden Infant Death Syndrome
(SIDS). In fact, since the NICHD launched the Back to Sleep SIDS risk
reduction campaign in 1994, the rate of SIDS in the United States has
declined by more than 50 percent. The NICHD continues a vigorous
research program to learn more about the causes and prevention of SIDS.
For instance, a team of NICHD-funded researchers in Ohio recently
discovered that infants who were placed to sleep on their backs were
less likely to develop fevers, get stuffy noses or develop ear
infection. Ear infections alone cost the health care system an
estimated $5 billion a year. So this simple behavior of placing infants
on their backs to sleep not only saves lives, it can save the health
care system large sums money by reducing the use of antibiotics to
treat ear infections. We also learned that infants who are normally
placed to sleep on their backs are at greatly increased risk of SIDS
when they are occasionally placed to sleep on their stomachs. New
research on SIDS continues to shape our SIDS risk reduction outreach
campaign. More recently, a major focus of the campaign has been
reducing the risks of SIDS in African American communities.
SIDS rates for African American babies have declined significantly
since the NICHD initiated its Back to Sleep campaign ten years ago.
Yet, the SIDS rate for African American infants is more than twice that
of white infants. To address this health disparity, the NICHD joined
forces with three national African American organizations in a unique
collaboration to reduce the risks of SIDS in African American
communities. The Alpha Kappa Alpha Sorority, the National Coalition of
100 Black Women, and the Women in the NAACP, sponsored three regional
summit meetings to raise SIDS awareness and train community leaders to
be resources and spokespersons for SIDS risk reduction in their
communities. The summit meetings were held in Tuskegee Alabama, Detroit
Michigan, and Los Angeles California, and they helped build an
infrastructure to involve faith-based, community, and service
organizations in reducing the risks of SIDS and in promoting the health
of infants. In Detroit, for instance, the summit ended with a ``SIDS
Sunday,'' which was held at Hartford Memorial Baptist Church on the
Sunday following that summit. Afterwards, other churches across the
region held a ``SIDS Sunday,'' where pastors shared SIDS information
from their pulpits, in their church bulletins, and with nurses and care
givers in their childcare centers and nurseries. The successful
collaboration of researchers, government officials, and the community
will create a strong foundation for launching other interventions to
eliminate health disparities.
MOTHERS LEAVING WELFARE HAD NO EFFECT ON PRESCHOOLERS
A study that received much of its funding from the NICHD
demonstrated that when a mother leaves welfare to enter the labor
force, it does not seem to have any negative effects on preschoolers or
young adolescents. The study was undertaken in response to the Personal
Responsibility and Work Opportunity Reconciliation Act of 1996, which
mandated stricter welfare requirements for all welfare recipients. The
researchers theorize that the positive and negative effects of going
off welfare and getting a job may cancel each other out. For example,
the increase in family income that comes with leaving welfare thought
to relieve the stress on a family may make up for the decreased amount
of time that mothers spend with their young children. In addition,
mother's transition to work had a slightly positive effect on teens,
reducing the teens' levels of anxiety. Conversely, teens whose mothers
left the job market and went on welfare developed increased anxiety
levels.
MICROBICIDES THAT CAN PREVENT SEXUALLY TRANSMITTED INFECTIONS
The NICHD is funding a number of projects to develop microbicidal
compounds to prevent the spread of sexually transmitted infections and
HIV. These compounds not only have the potential to prevent the spread
of disease-causing bacteria and viruses, but may also be effective in
preventing pregnancy. One project is a large scale test of the
contraceptive effectiveness of Buffergel, a compound that kills the
microorganisms that cause sexually transmitted diseases, and shows
promise as a contraceptive. Another project is studying a microbicidal
spermicide, C31G. The compound's effectiveness will be compared to that
of a conventional spermicide preparation. Working with the National
Institute of Allergy and Infectious Diseases, the NICHD has funded a
new system to test the quality of potential microbicides to determine
if they warrant further testing in human beings.
SAFER DRUGS FOR USE WITH CHILDREN
In January 2002, President Bush signed into law the Best
Pharmaceuticals for Children Act (BPCA). The law recognizes that drugs
may have different effects in children than they do in adults, and
seeks testing for drugs given to children. For roughly 75 percent of
the drugs approved by the U.S. Food and Drug Administration (FDA) for
adults, there is inadequate information available to ensure the safety
and effectiveness of the drugs in children. Moreover, there is little
or no data to guide physicians in prescribing dosages of these drugs
for children. Working in close collaboration, the NICHD and the FDA, as
directed by the BPCA, identified several high priority drugs to be
tested. The NICHD is currently establishing partnerships with pediatric
drug study networks in other NIH Institutes to expedite the study of
other clinically important drugs.
Drugs prescribed to pregnant women are also a concern. Although
nearly two-thirds of all pregnant women take at least four to five
drugs during pregnancy and labor, the effects of these drugs on a
pregnant woman and her fetus remain largely unstudied. In addition,
little is known about how pregnancy-related changes in cardiac output,
blood volume, intestinal absorption, and kidney function may influence
drug absorption, distribution, utilization, and elimination. Therefore,
the NICHD will establish a new network of Obstetric-Fetal Pharmacology
Research Units that will allow investigators to conduct key
pharmacologic studies of drug disposition and effect during normal and
abnormal pregnancies.
NATIONAL CHILDREN'S STUDY
In a few short years, The National Children's Study has evolved
from a concept to an exciting research collaboration poised to answer
critical questions about child development. The fiscal year 2005 budget
request continues planning dollars for this important project, but does
not reflect funding to launch the study itself, since it is still being
developed. The National Children's Study plans to examine the effects
of environmental influences on the health and development of more than
100,000 children across the United States, following them from before
birth until age 21. The NICHD serves as the lead agency on this
ambitious project, working closely with the National Institute of
Environmental Health Sciences, the Centers for Disease Control and
Prevention, and the U.S. Environmental Protection Agency. The
collaboration involves government agencies, the research community,
industry, and community groups.
NIH ROADMAP AND CLINICAL RESEARCH
To ensure that the necessary clinical research workforce is
available to translate laboratory findings to improved treatments for
patients, the NIH Roadmap is strengthening several stages in the career
path for these researchers. One new program will provide clinical
research experience and didactic training during medical and dental
school. Another will train doctorate-level professionals in multi
disciplinary collaborative clinical research settings that reflect the
diversity of today's clinical research team. To attract community
practitioners to clinical research, the NIH plans to create a cadre of
National Clinical Research Associates, community practitioners trained
in clinical research who will refer patients to large clinical trials
to enhance patient recruitment and more rapidly test potential
therapies. The NIH is also identifying ways to improve peer review of
clinical research grant applications and to enhance promotion and
tenure policies in academia for clinical researchers.
______
Prepared Statement of Dr. Allen M. Spiegel
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK) for fiscal year 2005, a sum
of $1,876,196,000, which includes $150 million for the Special
Appropriation for Research on Type 1 Diabetes through Sec. 330B of the
Public Health Service Act. The NIDDK transfers some of these funds to
other institutes of the NIH and to the Centers for Disease Control and
Prevention (CDC). Adjusted for mandatory funds, this is an increase of
$54,956,000 over the fiscal year 2004 enacted level of $1,821,240,000
comparable for transfers proposed in the President's request.
HIGHLIGHTS OF PROGRAM ENHANCEMENTS
I appreciate the opportunity to testify on behalf of the NIDDK's
efforts to combat the wide range of debilitating, chronic health
problems within our research mission, many of which are caused directly
or indirectly by obesity. Last year, I reported the creation of an
NIDDK Office of Obesity Research to intensify the fight against this
major public health problem, which is harmful both in its own right and
as a driver of type 2 diabetes, especially in minorities and the young.
Obesity can also be a contributing factor to nonalcoholic fatty liver
disease, gallstones, end-stage kidney disease, and urinary
incontinence. According to the CDC, approximately 64 percent of adults
and 15 percent of children and teens are considered either overweight
or obese. Disturbingly, these rates reflect skyrocketing trends over
the past two decades. To accelerate research to combat this epidemic,
the NIH Director established the NIH Obesity Research Task Force in
April 2003, with co-chairmanship by the Directors of the NIDDK and the
National Heart, Lung, and Blood Institute (NHLBI). I am pleased to
report that the Task Force has completed a draft Strategic Plan for NIH
Obesity Research, with input from external scientific and lay experts.
This Plan is posted on a newly established Web site that will alert
investigators to NIH obesity research funding opportunities, and also
inform the public about NIH efforts. Both the Plan and the Web site are
dynamic, and will evolve with changes in science and public health
needs. Acting alone, the NIH cannot halt or reverse obesity; however,
by generating and disseminating new research knowledge, we can lend a
vital scientific dimension to what must truly be a multifaceted
national effort.
The Strategic Plan will contribute to the prevention and treatment
of obesity by bolstering research in three major avenues: (1)
behavioral and environmental approaches to modify lifestyle; (2)
pharmacologic, surgical, or other biological/medical approaches; and
(3) ways to break the link between obesity and its associated health
conditions, known as co-morbidities. Within the goals and strategies
outlined in the Plan, the NIDDK will have a major role in three trans-
NIH initiatives.
The first is an effort to combat pediatric obesity in site-specific
ways--both in primary-care settings, and in other community settings,
such as the home, day-care, pre-school, school, and other venues.
Researchers will explore effective methods for the primary prevention
of inappropriate weight gain among children and adolescents who are not
overweight; secondary approaches to prevent further weight gain among
those already overweight or obese; and tertiary efforts to prevent co-
morbidities. We will build on studies the NIDDK is already pursuing to
evaluate the effects of so-called ``natural experiments'' in which
States or localities are changing the food and lifestyle choices and
cues that students encounter in school settings. We will also build on
studies to determine the effects of modifying the home environment,
such as the influence of T.V.-watching on obesity, eating behavior, and
physical activity. Our children are precious, and we should do all we
can to spare them the serious health problems that can attend a
lifelong struggle with obesity.
A second trans-NIH initiative will focus on the neurobiological
basis of obesity, which includes the intricate brain-gut circuits that
signal hunger and fullness, and thus are crucial to maintaining the
body's energy balance between calories consumed as food and expended in
physical activity. I previously reported on several hormones that
mediate energy-related signals, such as leptin, adiponectin, and
ghrelin. By exploiting these and other findings through innovative
collaborations between biomedical and behavioral researchers, we will
delineate the many pathways that modulate the control of eating
behavior in humans.
In a third trans-NIH initiative, the NIDDK will take the leadership
role in creation of an Intramural Obesity Clinical Research Program to
capitalize on the unique, collaborative infrastructure of the NIH
Clinical Research Center. This Program will foster multidisciplinary
approaches to obesity research in areas such as metabolism,
endocrinology, nutrition, cardiovascular biology, liver and other
digestive diseases, genetics, and the behavioral sciences. A ``magnet''
approach will draw upon the extensive expertise and resources of the
NIH intramural program to frame state-of-the-art clinical investigative
strategies and harness emerging technologies.
In addition to these trans-NIH initiatives, the NIDDK will support
a range of research, including ancillary studies to maximize the
resources already invested in ongoing clinical trials. We will pursue
challenging questions about obesity. What factors control where fat is
deposited, and the relationship between its location and differences in
metabolism, fat-cell regeneration, cell signaling, and associated co-
morbidities of obesity? What is the relationship between obesity and
abnormal levels of circulating and stored lipids, which are a hallmark
of metabolic problems? Can we identify biomarkers of change brought on
by the obese state? What genetic abnormalities underlie the co-
morbidities of obesity? What steps can people take to achieve long-term
maintenance of weight loss?
As obesity is escalating in the United States, so is type 2
diabetes. New estimates from the CDC place the number of people with
diabetes at 18.2 million, and about 90-95 percent of them have this
form of the disease. Disturbingly, about 5.2 million of those affected
are unaware. Millions of adults also have a condition called ``pre-
diabetes,'' in which glucose levels are elevated, but not as high as in
full-blown diabetes. Because clinical trials have demonstrated that
lifestyle and medical interventions can significantly delay or prevent
disease onset in those at high risk, it is critical to identify these
individuals and underscore the preventive actions they can take. The
NIDDK is taking vigorous steps to foster the generation of new
laboratory tests to improve diabetes detection, as well as to promote
the development of more cost-effective strategies to pinpoint those at
risk who can benefit most from early intervention. We are also
supporting studies to translate important advances from clinical trials
in diabetes prevention and care into medical practice. For example, for
a low-income Latino population, we are supporting a clinical trial to
compare current translation efforts for type 2 diabetes prevention with
a method that incorporates culturally-sensitive strategies. We are also
studying an interactive video conferencing system to enable
communication between health professionals at a large medical center
and diabetes patients in a rural state, with limited access to health
care providers. Interventions that are successful in these trials could
pave the way to widespread use by communities throughout the country.
Once considered an ``adult-onset'' disease, type 2 diabetes is
being increasingly diagnosed in children and adolescents, especially in
minority populations. We are launching a multi-center, school-based
trial (STOPP-T2D) to find ways to prevent the development of risk
factors for type 2 diabetes in middle-school children. The trial will
include school-based programs targeting nutrition, physical activity,
and behavior modification. Another multicenter trial (Treatment Options
for Type 2 Diabetes in Adolescents and Youth TODAY) will seek the best
treatment strategies.
Diabetes can lead to serious complications, such as blindness,
irreversible kidney failure, lower limb amputation, and heart disease.
We have established an NIDDK Diabetes Complications Working Group,
which is charged with seamless integration of these activities across
the Institute. The NIDDK also recently convened an international group
of clinical and basic researchers to brainstorm research approaches to
the urologic complications of diabetes. Because complications can
affect many organs, we collaborate with other components of NIH and the
Department to benefit from their expertise. For example, studies have
shown that the process of new blood vessel formation, called
``angiogenesis''--traditionally studied in relation to cancer--is also
critically important to vascular changes in diabetes, such as the
dangerous proliferation of blood vessels in the eye that can lead to
blindness. Angiogenesis will be the central theme of a new research
collaboration involving multiple NIH institutes.
In an aggressive research program on type 1 diabetes, we have
established unique, innovative, and collaborative research groups,
clinical trial networks, and consortia, with an overarching group to
standardize and coordinate their efforts. We are also working to
overcome barriers that currently prevent widespread clinical research
on islet transplantation to restore normal insulin-producing capacity
to patients. In collaboration with the National Institute of Allergy
and Infectious Diseases (NIAID), we are establishing a national
consortium to step up progress toward general clinical applicability of
islet transplantation.
To spur research in digestive diseases, the NIDDK recently
established a new Liver Disease Branch within its Division of Digestive
Diseases and Nutrition. With expert external input, this Branch is now
spearheading the development of a Liver Disease Research Action Plan
under the auspices of the Digestive Diseases Interagency Coordinating
Committee. As requested by the Congress, the NIDDK is submitting a
report on actions taken by the NIH and other HHS components in response
to recommendations from a Consensus Conference on hepatitis C. In other
research, broad approaches are providing insights into the inflammatory
bowel diseases--Crohn's disease and ulcerative colitis. Fundamental
studies are shedding light on the development of pathways that control
gut motility; integration of pain, motility and behavioral neural
circuits; and gut inflammation.
For polycystic kidney disease (PKD), a research consortium has
established the value of Magnetic Resonance Imaging for measuring
kidney size. This advance portends dramatic improvements in assessing
disease progression--a critical step in developing and evaluating new
treatments. The HALT-PKD Network is testing a regimen designed to lower
blood pressure and slow disease progression--the first of several
clinical studies envisioned. A workshop on oxalosis and primary
hyperoxaluria--an inherited cause of kidney stone disease--has
identified future clinical research directions, which will apply
emerging knowledge about underlying metabolic and genetic
abnormalities. We have also launched or expanded initiatives on
interstitial cystitis, urinary incontinence, and urinary tract
infections, consistent with the scientific recommendations of the
Strategic Plan of the Bladder Progress Review Group. A recently formed
Interstitial Cystitis (IC) Epidemiology Task Force is guiding efforts
in that area, as described in a requested report to the Congress.
TRANSLATION RESEARCH AND ROADMAP EFFORTS
Underpinning our disease-focused programs is an emphasis on
``translation'' research, which benefits patients directly by bringing
the fruits of laboratory discoveries into the arena of clinical
research, and by propelling the positive results of clinical trials
into medical practice. In one promising pilot effort to speed the
development of therapies for type 1 diabetes, we are building on an
innovative mechanism established by the NCI called ``Rapid Access to
Intervention Development.'' We are also pursuing several translational
efforts related to the NIH Roadmap for Biomedical Research. These
include development of non-invasive methods for diagnosing and
monitoring the progression of diabetes, kidney and digestive diseases;
harnessing new technologies such as proteomics the study of proteins
and their functions; as well as studying stem cells during human
development and tissue repair. We are leading an NIH Roadmap initiative
in ``New Pathways to Discovery'' by enhancing metabolomics--the study
of networks within the cell, and constituents of the cell, such as
carbohydrates, lipids, and amino acids. We are also playing a major
role in Roadmap efforts to build ``Research Teams of the Future'' by
spurring interdisciplinary research training. These efforts can benefit
programs within the NIDDK mission by bridging scientific disciplines
and catalyzing partnerships, such as collaborations between biomedical
and behavioral researchers, which are so important to moving obesity
research forward.
Today, I have presented a cameo of our many and diverse research
efforts and plans. Our research momentum has never been greater, and
our commitment to improving health remains clear and strong.
______
Prepared Statement of Dr. Sharon H. Hrynkow
Mr. Chairman and Members of the Committee, I am pleased to present
the President's Budget for the Fogarty International Center for fiscal
year 2005, a sum of $67,182,000, which reflects an increase of
$1,838,000 over the comparable fiscal year 2004 appropriation.
I welcome this opportunity to relate Fogarty's progress over the
past year and proposed plans for fiscal year 2005. Programs at Fogarty,
developed with the support and guidance of the Administration and this
Committee, reflect our nation's enduring commitment to achieve ``a
healthy America, in a healthier world.'' These were the words of the
late Congressman John E. Fogarty, Chairman of the House Appropriations
Subcommittee from 1951 until 1967, and for whom the center is named. He
championed research as the one truly global effort in which all nations
can and will join as real partners.
The health challenges facing the United States are many. Among the
communicable diseases, AIDS and tuberculosis continue to challenge even
the most sophisticated public health interventions. SARS emerged in
Asia and washed upon our shores, as did West Nile Virus several years
ago. And the emergence of avian flu in Asia and the United States is a
compelling tale that is a harbinger of probable Asian flu pandemics yet
to come. All told, the infectious threats cost our economy dearly. And
as chronic disease such as cancer, cardiovascular disease, and mental
health disorders increase year after year in the United States and
world-wide, both treatment and prevention efforts must be applied.
These challenges are shared with communities around the world.
To address these challenges, Fogarty supports a broad range of
research and training programs, each designed to tackle particular
health problems shared by United States and foreign populations. Our
particular focus is on improving the capacity of communities in poor
settings to address health challenges. Accordingly, our emphasis has
been on working with scientists and health professionals in low- and
middle-income nations on shared health problems. Our programs identify
research opportunities best addressed through international
cooperation. Fogarty's efforts are multidisciplinary, embracing
clinical, epidemiological, basic biomedical and social science
research. They are multi-sectoral, closely coordinated with our sister
institutes at NIH, the Centers for Disease Control and Prevention, and
international organizations with health and development missions,
including The World Bank and the World Health Organization. Moreover,
the programs enhance foreign relations with governments and communities
alike, and advance the historic humanitarian role of our nation. And
importantly, our programs promote a global culture of science, founded
on equal partnerships between scientists working across borders, in a
culture of sharing of scientific information, peer review and sound
management policies. Fogarty supports over twenty research and training
programs in more than 100 countries, involving more than 5,000
scientists in the United States and abroad.
What follows is a selective summary of ongoing and planned Fogarty
activities to support NIH international objectives and realize
Congressman Fogarty's vision.
THE HIV/AIDS EMERGENCY
HIV/AIDS has exacted a profound human toll in the United States and
abroad, reversed gains in child survival in many nations, and
threatened the economic stability of emerging markets by reducing the
number of working men and women. Reducing the impact of HIV/AIDS in
resource-poor countries, which bear the disproportionate burden of this
disease, requires a strong national commitment on their part and
international research cooperation to develop effective prevention and
control strategies. The Fogarty AIDS International Training and
Research Program (AITRP), now in its 16th year of operation, has been a
major source of support for training a cadre of foreign medical
scientists from developing countries needed to combat the global HIV/
AIDS pandemic. Working through U.S. universities, Fogarty has supported
Masters level, Ph.D., and post-doctoral training for young scientists
in countries most affected by the pandemic. These scientists are
testing HIV/AIDS vaccines abroad, developing effective public health
strategies to reduce transmission, and acquiring new knowledge for
treatment for those already infected.
Through the Fogarty AIDS Program, nearly 2,000 foreign researchers
from over 100 countries have been trained in the United States, many at
senior levels, and over 50,000 have trained in cutting-edge laboratory
methodologies through workshops and courses conducted in those
countries where HIV/AIDS is most devastating. This large international
cadre of trained scientists has facilitated the implementation of new
programs such as the Pediatric AIDS Foundation Call-To-Action, the
President's initiative on prevention of maternal-to-infant transmission
of HIV, and the President's Emergency Plan for AIDS Relief (PEPFAR). In
addition, health scientists trained under the program have played vital
roles in helping approximately 20 countries receive awards from the
Global Fund for AIDS, TB and Malaria. As we work in partnership with
colleagues around the world, the benefits of the Fogarty AIDS program
accrue also in the United States. Interventions and strategies
developed and tested abroad may have direct relevance to communities in
the United States.
Among research accomplishments in the past fiscal year, scientists
at the University of North Carolina and the University of Malawi have
identified a new and effective means to minimize postpartum
transmission of HIV through implementation of an inexpensive two-drug
antiretroviral regimen. This is of significance because low-income
women in sub-Saharan Africa typically do not obtain medical attention
during pregnancy and are usually uninformed of their HIV status until
delivery. Effectively deployed, this intervention will mean that more
newborn infants will have a chance to grow to be healthy adults, even
where the lack of resources and other obstacles to extending medical
care limit prenatal care and interventions.
CHANGING MICROBIAL THREATS
HIV/AIDS is a cautionary example. The rapid emergence of new
pathogens and re-emergence of infectious disease, believed to have been
controlled or contained, presents a disturbing new chapter in the grim
evolutionary battle between humans and microbes. This is the result of
social and demographic trends, including increases in international
travel and trading across borders, and changes in the genetic structure
of microbes that increase virulence and transmission, and weaken the
efficacy of existing drugs. Among major disease pathogens, malaria has
resurged due to resistance of the parasite to available drugs and
resistance of mosquitoes to insecticides. Malaria accounts for an
estimated 2 million deaths per year with increasing mortality due to
drug resistance and HIV-contaminated blood transfusions related to
malaria-induced anemia.
Building on the success of the AIDS training program, Fogarty
launched in 1996 the International Training and Research in Emerging
Infectious Diseases, a training program which builds expertise in
microbiology, epidemiology, and laboratory methods as part of a broad
effort to combat new and emerging diseases worldwide. Today, that
program has been expanded to include other infectious diseases as the
Global Infectious Disease Research Training Program, linking U.S.
universities with counterparts around the world to advance research
projects (through 27 Fogarty awards) and, importantly, to build the
next generation of scientists able to combat emerging infections, such
as SARS and West Nile Virus. Through this program, Fogarty is helping
to address the infectious disease challenges of today while preparing
for new pathogens yet to emerge tomorrow, as surely they will.
A powerful new tool for malariologists and other infectious disease
researchers concerns the use of sophisticated mathematics to predict
the course of an epidemic. Such mathematics, sometimes termed models,
can be used to chart the benefits of prevention and control measures.
Most recently, mathematical models were used to project the course of
the SARS epidemic in Asia, and to develop strategies to limit the
spread of the disease. Several years ago, Fogarty established a unit at
NIH concerned with the use of mathematical models for control and
prevention of several diseases, including malaria. The elements of a
malaria prevention program include reducing the population of
mosquitoes, treatment of malaria patients, and use of personal
protection such as bed nets to prevent mosquito bites. In addition,
there is a major effort underway to develop a malaria vaccine. The
Fogarty epidemiologists have used mathematical models to determine the
best strategy to employ such a vaccine, when it becomes available,
along with existing methods of malaria control and prevention. All this
must be done within the various complex ecological settings in which
malaria occurs. The use of such advanced mathematics in devising the
most effective strategies in the study of infectious diseases will
surely bring unexpected benefits to human kind. Importantly, through a
network of in-house research experts and extramural scientists, Fogarty
also employs mathematical models to assist biomedical research and
public health policy-makers prepare for and respond to bioterrorism
events. In coordination with DHHS, Fogarty has mobilized experts in
epidemiology, terrorism-response and public health policy in the
context of category A agents including plague, tularemia smallpox and
anthrax.
THE EMERGING EPIDEMICS OF CHRONIC DISEASE
By the year 2020, chronic disease is expected to contribute 60
percent of the global disease burden. The toll in the United States is
already enormous: for example, obesity has more than doubled from 15
percent during 1976-1980 to 31 percent in 1999-2000, and 65 percent of
adults ages 20 to 74 were overweight to obese in 1999-2000. As
populations age, and risk exposures shift due to environmental and
dietary factors, non-communicable diseases are estimated to become a
leading source of disability and premature death in developing nations
as well. Tobacco-caused disease and death is a major concern in the
United States and globally. In the United States, while picking up the
habit of smoking is on the decline in most groups, in young girls it is
on the rise (The World Bank). In low- and middle-income nations, as
wealth increases in urban settings, smoking commencement in youth, and
particularly in girls, is rising at alarming rates (The World Bank). To
address this challenge, Fogarty launched in 2002 its International
Tobacco and Health Research and Capacity Building Program. While in its
early stages, our expectation is that research will lead to new
interventions that will benefit U.S. communities as well as those
around the world.
There is a growing awareness of the burden on health inflicted by
trauma and injury both in the United States and worldwide. The numbers
are startling: more than 1.2 million people are killed in traffic
accidents annually, and millions more are injured or disabled. Deaths
from all types of injuries, including war and domestic violence, are
projected to rise from 5.1 million in 1990 to 8.4 million in 2020, with
road traffic injuries as a major cause for this increase, with millions
more sustaining injury that results in life-long disability. In
response to the growing epidemic of trauma, Fogarty is initiating a new
research and training program. Among the features of the program will
be training across the range of basic to applied sciences, the
epidemiology of risk factors, acute care and survival, rehabilitation,
and the long-term mental health consequences. Possible research areas
will include development of low-cost synthetic blood products and
diagnostic imaging tools, identification of behavioral intervention
strategies, particularly in youth and other high-risk groups, and
health services research to determine cost-effective measures for
emergency care in low-income settings. The new knowledge from the
program will benefit not only developing countries but, as low-cost and
effective strategies are identified, communities in the United States.
PREPARING THE NEXT GENERATION OF U.S. GLOBAL HEALTH LEADERSHIP
While Fogarty works to build capacity and train young scientists in
the developing world, critical steps have been taken to ensure that
U.S. investigators at a formative stage in their careers also have
opportunities to engage in international research projects. The Center
will enhance and expand two programs to bring the next generation of
U.S. scientists more fully into the global culture of science. The
first of these, the International Research Scientist Development Award
(IRSDA) program, provides post-doctoral training for four years, two of
which must be spent conducting research in a developing country. Nearly
20 U.S. scientists are now being supported as IRSDA trainees.
Addressing an earlier step in the career path, Fogarty has recently
teamed with the Ellison Medical Foundation to create a second program,
the new pre-doctoral clinical research training program for U.S.
medical and public health students. Under this program, students will
spend a year in a developing country conducting NIH-sponsored clinical
research under the mentorship of an experienced foreign investigator
and a collaborating research team. The first students to be selected
will begin the program this summer.
ENHANCING OPPORTUNITIES FOR WOMEN IN SCIENCE
NIH's goal to bolster the nation's intellectual capital includes
attracting more women to careers in science, both to build a new
generation of talented scientists and to ensure that research issues
germane to women's health are addressed. Fogarty has extended this
important goal to international programs. At an October 2003 colloquium
on career path issues facing women in the life sciences, including
women in the developing world, Fogarty and its co-sponsors, the NIH
Office of Research on Women's Health and the National Institute of
Environmental Health Sciences, invited perspectives on opportunities in
advancing career issues for women in the life sciences from a community
of scientists, administrators and science funding agencies. To follow
up on the recommendations, Fogarty and its partners have agreed to:
collect data on developing country women in science and their career
paths; support workshops to develop skill sets for women scientists in
the developing world that will better enable them to take on leadership
roles within health research and/or policy settings; and develop and
implement strategies to effectively use the Internet and other
information technologies to support networking and mentorship.
ADVANCING THE NIH ROADMAP: GLOBAL POSITIONING
Fogarty supports programs linked to each of the three main Roadmap
themes--New Pathways to Discovery, Research Teams of the Future, and
Re-Engineering the Clinical Research Enterprise. In particular, to
improve the clinical research enterprise, Fogarty supports two new
programs aimed at training developing country professionals in
clinical, operational and health services research. These programs
represent a new approach to enhance clinical research, and pave the way
for new partners, namely those in low- and middle-income nations, to
work more closely on mental health, and on AIDS and TB with U.S.
counterparts. In support of Roadmap themes of new approaches and new
pathways to discovery, Fogarty is also supporting studies to identify
the impact of environmental degradation on economic development and
human health. These programs link social scientists, including
mathematicians and economists, with clinicians and medical researchers
to provide new insights and strategies to tackle urgent global health
challenges.
CONCLUSION
Mr. Chairman, global challenges require a global response.
Collective action is not only an economically rational approach to
global health research challenges, but a scientific and humanitarian
imperative. With the continued support of this Committee, Fogarty will
accelerate both research discoveries and applications through
international cooperative action to the benefit of the United States
and to global communities. ``A healthy America in a healthier world''
has never been as important as it is today. Thank you.
______
Prepared Statement of Dr. Roderic I. Pettigrew
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Biomedical
Imaging and Bioengineering (NIBIB) of the National Institutes of Health
(NIH). The fiscal year 2005 budget includes $297,647,000, an increase
of $8,817,000 over the fiscal year 2004 enacted level of $288,830,000
over the comparable fiscal year 2004 appropriation.
The NIBIB's mission is to improve human health by leading the
development and accelerating the application of biomedical
technologies. The Institute is committed to integrating the physical
and engineering sciences with the life sciences to advance basic
research and health care. Our vision is to profoundly change healthcare
by pushing the frontiers of technology to make the possible a reality.
PROGRESS TOWARDS SUCCESS
Established by law in December 2000, the NIBIB has already
demonstrated an impressive track record as a conscientious steward of
public funds and has achieved significant milestones. In fiscal year
2003 the NIBIB funded approximately 750 awards, including 300 new
awards that received outstanding scores in a highly competitive peer
review system. Consistent with our mission, approximately one-third of
our new awards were for innovative, high-impact, though high-risk,
exploratory studies. These studies addressed the feasibility of a novel
avenue of investigation and/or breakthroughs in biomedical imaging and
bioengineering within a specific area. The Institute has also been
effective at reaching segments of the scientific community that
traditionally have not been supported by the NIH, especially those from
the engineering and quantitative sciences. Between the first and second
years of our grant-making authority, proposals to the NIBIB from first-
time NIH applicants increased significantly. In fiscal year 2003,
approximately 50 percent of respondents to requests for targeted
applications identified themselves as first-time NIH applicants.
The Institute has built a solid research infrastructure through the
issuance of numerous basic and applied research solicitations in
promising areas of scientific investigation. Responses to the
Institute's targeted initiatives far exceeded even the most optimistic
estimates based on prior NIH experience. Coupling this to the
successful outreach to new applicants and to the science community, it
is clear that NIBIB is filling an important need with regard to
catalyzing interdisciplinary science and supporting engineering
research aimed at translating scientific discoveries to practical
applications.
The NIBIB continues to foster successful linkages and
collaborations with other NIH Institutes and Centers, Federal agencies,
academic institutions, and private industry. We regard input from
industry as critical for helping to identify research needs that will
result in significant healthcare improvements as well as for
translating technologies and research results to patient applications.
As a first step in establishing collaboration with the biomedical
industry, the NIBIB sponsored a workshop on ``Biomedical Industry
Research and Training Opportunities'' in December 2003. Recommendations
from this meeting will be considered in the planning and development of
future NIBIB programs.
ADVANCING TOMORROW'S TECHNOLOGIES TODAY
Biomedical imaging and bioengineering are interdisciplinary fields
requiring collaborations not only among imagers and engineers, but also
with biologists, chemists, mathematicians, computer scientists, and
clinicians of all specialties. Today, the imaging and engineering
sciences are essential for improved understanding of biological
systems, detecting and treating disease, and improving human health.
Recent advances in these fields have enabled the diagnosis and
treatment of various diseases using increasingly less invasive
procedures. Benefits associated with minimally invasive imaging
applications include quicker and more accurate diagnoses leading to
improved patient outcomes at reduced costs. Minimally invasive image-
guided interventions now serve as powerful tools in the operating room
and can be applied to surgical procedures in urology, oncology,
neurosurgery, ophthalmology, orthopedics, and cardiology.
The quest for faster and more effective minimally invasive surgical
interventions has resulted in the introduction of computer-assisted
robotic technology, whereby the surgeon works with small tools through
small incisions. However, current instrumentation prohibits the surgeon
from actually feeling the forces exerted when manipulating tissue. This
lack of sensory control can be particularly detrimental in surgery,
where the forces applied to sutures are critical in creating knots that
are strong enough to hold, but do not damage the tissue. To overcome
this problem, NIBIB investigators are developing instruments with
three-dimensional sensors designed to give the surgeon a feeling
comparable to that of performing the task manually. This research has
additional applications as well, including expert-assisted surgery in
remote locations.
Magnetic resonance imaging (MRI) has been used successfully for
over 15 years to generate soft tissue images of the human body.
However, a number of diagnostic MRI applications require further
improvements in both imaging speed and spatial resolution. For example,
accurate abdominal imaging generally requires a complete image obtained
during a single ``breath-hold'' period, which can take up to 30
seconds. Many patients, especially those with respiratory illnesses,
cannot tolerate long breatholds. The NIBIB supports an active research
program on optimizing MRI speed and spatial resolution. One new
approach under study, called parallel imaging, collects MRI signals
from a number of independent coil shaped antennas. The appropriate
combination of these signals can provide an order of magnitude
improvement in imaging speed or resolution. Enhancements such as this
hold promise for greatly enhancing the non-invasive diagnosis and
treatment of abdominal and neurological diseases.
Functional magnetic resonance imaging (fMRI) is a relatively new
technique that builds on the basic properties of MRI to measure quick
and tiny blood flow related metabolic changes that take place in the
active brain. Thus, fMRI studies are capable of providing not only an
anatomical view of the brain, but a minute-to-minute recording of
actual brain activity. This technology is now being used by NIBIB
researchers to precisely map functional areas of the normal, diseased,
and injured brain and to assess risks associated with surgery or other
invasive treatments. Functional MRI can help physicians determine
exactly which parts of the brain are responsible for specific crucial
functions such as thought, speech, movement, and sensation. This
information allows physicians to better plan surgeries and radiation
therapies and to guide interventional strategies for a variety of brain
disorders.
Molecular imaging provides a way to monitor cellular activities in
normal and diseased states. The development of novel imaging
technologies, combined with new or enhanced probes that bind to and
``highlight'' defined cellular targets, will allow this technique to be
more broadly applied to biomolecules that are known indicators of a
diseased state. For example, NIBIB researchers have developed nanometer
sized fluorescent crystals, called quantum dots, that glow and can act
as markers for specific cells when bound to certain targeting agents
such as cancer cell antibodies. These agents can more precisely
pinpoint the location of the sentinel lymph node in breast cancer
patients. The sentinel node (SN) is the first node in the body to come
into contact with cancer cells as they leave the breast and begin to
spread to the rest of the body. Testing for metastatic cancer cells in
the SN allows for accurate staging using information from a single
lymph node, rather than 10 to 15 axillary nodes, and allows patients to
avoid many of the complications and side effects associated with a
traditional axillary lymph node dissection.
Advances in bioinformatics have been identified as having great
potential for positively impacting medical science and health care.
NIBIB researchers are developing and evaluating several innovative
technologies designed to help solve the information management problems
faced by today's doctors. Concepts enveloped in this system include a
medical record architecture designed for portability; a mechanism for
linking laboratory findings with medical problems; and a real-time,
context-sensitive visualization of the medical record. Taken together,
these concepts form a comprehensive system for facilitating evidence-
based medicine in a real-world setting.
NEW BIOMATERIALS FOR TISSUE ENGINEERING
Tissue engineering holds the promise to repair and/or replace
damaged organs using biologic materials. For success in this area, a
number of scientific and bioengineering challenges must first be met.
For example, we must learn to produce, manipulate, and deliver
collections of cells not only as building blocks for tissues and organ
systems, but as models for studying drug development. Toward this goal,
NIBIB researchers have successfully transformed adult rat engineered
tissue cells into cells that form cartilage and bone. The two cell
types were integrated into separate layers, encapsulated in a gel-like
biocompatible material, and shaped into the ball structure of a human
jaw joint. Although more work is needed before this tissue-engineered
joint can be used in humans, it holds great potential for treating
patients with temporomandibular disorders, osteoarthritis, and
rheumatoid arthritis. These procedures could also be further refined
and adapted for developing artificial knee and hip joints.
Coronary stents are small devices that serve as a scaffold to prop
open the inside of an artery and provide vessel support. They are
commonly made of stainless steel or nylon mesh and therefore remain as
a permanent implant in a blood vessel. Although stents have
revolutionized the treatment of coronary artery disease, limitations
include an inflammatory reaction and the development of stent closure
due to blood clots forming within the device, a process termed
restenosis. To address this problem, NIBIB researchers have recently
developed a mechanically strong, hemocompatible, and X-ray visible
polymer as a noninflammatory fully-degradable coronary stent. While
designed as a stent, work continues to refine the device to serve
additionally as a drug-delivery vehicle. This may also have application
as a drug-delivery mechanism for other diseases, such as cancer.
SENSORS FOR MEDICINE
Biosensors are nanoscale or microscale devices that detect,
monitor, and transmit information about a physiological change, or
indicate the presence of various chemicals, gases, or biological
materials. Laboratory diagnostics used in hematology, clinical
chemistry, pathology, and microbiology already employ sensor
technologies to perform simultaneous measurements for many substances
in urine, blood, saliva, sweat, and interstitial fluids. The Institute
has an active research program in sensor technologies and continues to
expand this important area. For example, NIBIB researchers are
engineering recombinant antibody fragments (recAbs) that will increase
the sensitivity and specificity of a type of biosensor called a
piezoimmunosensor. Piezoimmunosensors have been proposed for almost 20
years; however, there has been no procedure for providing a sensing
layer that is uniform, chemically stable during the measurement
process, and contains high numbers of binding sites. By creating
tightly packed monolayers of recAbs that will bind to the surface of
the sensing unit, researchers are solving this problem while also
preventing non-specific interactions with molecules, and thus improving
specificity.
Other researchers are focusing on the design and fabrication of
miniaturized implantable responsive drug delivery devices that
integrate a smart drug delivery system with a biosensor. These drug
delivery systems are aimed at providing individualized therapies that
monitor the patient's body chemistry and control drug flow as needed.
NIH ROADMAP
To transform the Nation's medical research capabilities and to
speed the movement of research discoveries from the bench to the
bedside and into medical practice, the NIH has laid out a series of
far-reaching initiatives known collectively as the NIH Roadmap for
Medical Research. The NIH Roadmap focuses on the most compelling
opportunities in three main areas: new pathways to discovery, research
teams of the future, and re-engineering the clinical research
enterprise.
The NIBIB mission also strongly supports the NIH Roadmap
initiative, since the Roadmap goal is to facilitate the development of
innovative, novel and multidisciplinary science and technology that has
the potential to further advances in health care. For example, the
NIBIB is participating in an initiative that will facilitate the
formation of collaborative research teams capable of generating novel
probes for molecular and cellular imaging. The overall goal is to
establish programs to create complete tool sets for the detection of
single molecule events in living cells and to generate new strategies
for dramatically increasing the imaging resolution of dynamic cellular
processes.
Other areas of immediate interest to and supported by the NIBIB
include the development of nanomedicine technologies, new tools for the
study of proteomics and metabolic pathways, data and techniques for
computational biology, and advances in bioinformatics. The NIBIB also
strongly supports the NIH Roadmap theme on research teams of the future
through sponsoring multidisciplinary research and interdisciplinary
training.
MULTIDISCIPLINARY RESEARCH TEAMS
The value of collaboration among disciplines and organizations has
long been recognized as important for developing novel approaches to
problems in biology and medicine, and for effectively translating
research results to patient applications. We are pleased to report that
there have already been some successful ``NIBIB partnerships'' between
biomedical engineers and imaging scientists that have had significant
impacts on healthcare. For example, an ongoing Bioengineering Research
Partnership team is using fMRI to integrate information on the
suspected location of brain seizures with information about surrounding
brain function in order to improve surgical outcome and reduce or
eliminate seizures. In one early phase study, surgery employing fMRI
strategies was used to almost eliminate seizures in a patient who had
been suffering from as many as 100 seizures daily.
In conclusion, the NIBIB is dedicated to promoting the development
of emerging technologies and interdisciplinary collaborations that
drive healthcare advances. I would be pleased to respond to any
questions that the Committee may have.
______
Prepared Statement of Dr. Jack Whitescarver
Mr. Chairman and Members of the Committee, I am pleased to present
the President's budget request for the AIDS research programs of the
NIH for fiscal year 2005, a sum of $2,930,397,000 an increase of 5,000
above the comparable fiscal year 2004 appropriation.
The NIH represents the largest and most significant public
investment in AIDS research in the world a comprehensive program of
basic, clinical, and behavioral research on HIV infection and its
associated opportunistic infections and malignancies. Perhaps no other
disease so thoroughly transcends every area of clinical medicine and
scientific investigation, crossing the boundaries of the NIH
institutes. The Office of AIDS Research (OAR) plays a unique role at
the NIH. OAR coordinates the scientific, budgetary, and policy elements
of the NIH AIDS program, supported by nearly every Institute and
Center; prepares an annual comprehensive trans-NIH plan and budget for
all NIH-sponsored AIDS research; facilitates NIH involvement in
international AIDS research activities; and identifies and facilitates
scientific programs for multi-institute participation in priority areas
of research.
WORLDWIDE PANDEMIC
AIDS is the deadliest epidemic of our time. More than 22 million
people have already died of AIDS--3 million of them in 2003 alone--the
largest number ever. HIV has already infected more than 60 million
people around the world, and AIDS has surpassed tuberculosis and
malaria as the leading infectious cause of death worldwide.\1\
---------------------------------------------------------------------------
\1\ ``Report on the Global HIV/AIDS Epidemic: July 2002,'' (UNAIDS/
WHO, Geneva, Switzerland, 2002).
---------------------------------------------------------------------------
The United Nations General Assembly's Declaration of Commitment on
HIV/AIDS states ``. . . the global HIV/AIDS epidemic, through its
devastating scale and impact, constitutes a global emergency and one of
the most formidable challenges to human life and dignity, as well as to
the effective enjoyment of human rights, which undermines social and
economic development throughout the world and affects all levels of
society national, community, family, and individual.'' \2\ According to
a U.N. report, ``The epidemic has not only killed people; it has
imposed a heavy burden on families, communities and economies. The
misery and devastation already caused by HIV/AIDS is enormous, but it
is likely that the future impact will be even greater . . . The HIV/
AIDS epidemic has erased decades of progress in combating mortality and
has seriously compromised the living conditions of current and future
generations. The disease has such a staggering impact because it
weakens and kills many people in their young adulthood, the most
productive years for income generation and family caregiving. It
destroys families, eliminating a whole generation crucial for the
survival of the younger and older persons in society.'' The report also
highlights ``the long-term damage accruing to human capital, as
children's education, nutrition and health suffer directly and
indirectly as a consequence of HIV/AIDS. The effects of lowered
investment in the human capital of the younger generation will affect
economic performance for decades to come, well beyond the timeframe of
most economic analysis.'' \3\ Another dimension to the epidemic in
Africa was cited in the New York Times: ``As a result of HIV, the
worst-hit African countries have undergone a social breakdown that is
now reaching a new level: African societies' capacity to resist famine
is fast eroding. Hunger and disease have begun reinforcing each
other.'' \4\
---------------------------------------------------------------------------
\2\ ``The Impact of AIDS'' (Department of Economic and Social
Affairs, United Nations, 2003).
\3\ Ibid.
\4\ A. de Waal, ``What AIDS Means in a Famine,'' New York Times,
11/19/02.
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A recent CIA report estimated that by 2010, five countries of
strategic importance to the United States--Nigeria, Ethiopia, Russia,
India, and China--collectively will have the largest number of HIV/AIDS
cases on earth.\5\ Foreign Affairs magazine stated: ``The spread of
HIV/AIDS through Eurasia, in short, will assuredly qualify as a
humanitarian tragedy--but it will be much more than that. The pandemic
there stands to affect, and alter, the economic potential--and by
extension, the military power--of the region's major states . . . Over
the decades ahead, in other words, HIV/AIDS is set to be a factor in
the very balance of power within Eurasia--and thus in the relationship
between Eurasian states and the rest of the world.'' \6\ Dramatic
increases in HIV infection also are occurring in Eastern Europe,
Central Asia, Latin America, and the Caribbean.
---------------------------------------------------------------------------
\5\ ``Intelligence Community Assessment: The Next Wave of HIV/AIDS:
Nigeria, Ethiopia, Russia, India, and China.'' (CIA, 2002).
\6\ ``The Future of AIDS,'' Foreign Affairs, November/December
2002.
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THE U.S. EPIDEMIC
According to CDC, the decline in death rates observed in the late
1990s, due largely to expanded use of new antiretroviral therapies
(ART) that prevent progression of HIV infection to AIDS, has now
leveled off; and AIDS incidence increased 2 percent in 2002 (over
2001). This means that the overall epidemic is continuing to expand.\7\
\8\ \9\ In addition, use of ART has now been associated with a series
of side effects and long-term complications that may have a negative
impact on mortality rates. HIV infection rates are continuing to climb
among women, racial and ethnic minorities, young homosexual men,
individuals with addictive disorders, and people over 50 years of
age.\10\ The appearance of multi-drug resistant strains of HIV presents
an additional serious public health concern.\11\ \12\ \13\ \14\ \15\
According to CDC reports, approximately one quarter of the HIV-infected
population in the United States also is infected with hepatitis C virus
(HCV). HIV/HCV co-infection is found in 50 to 90 percent of injecting
drug users (IDUs). HCV progresses more rapidly to liver damage in HIV-
infected persons and may also impact the course and management of HIV
infection, as HIV may change the natural history and treatment of
HCV.\16\ This expanding and evolving U.S. epidemic presents new and
complex scientific challenges.
---------------------------------------------------------------------------
\7\ CDC Year-End HIV/AIDS Surveillance Report for 2002 (CDC, 2003).
\8\ ``Centers for Disease Control and Prevention HIV Prevention
Strategic Plan Through 2005,'' (CDC, 2001).
\9\ ``HIV/AIDS Update--A Glance at the HIV Epidemic,'' (CDC, 2001).
\10\ ``U.S. HIV and AIDS Cases Reported Through June 2000,'' CDC
HIV/AIDS Surveillance Report, Vol. 12 (2002).
\11\ N. Loder, Nature 407, 120 (2000).
\12\ H. Salomon et al., AIDS 14, 17 (2000).
\13\ Y.K. Chow et al., Nature 361, 650 (1993).
\14\ M. Waldholz, ``Drug Resistant HIV Becomes More Widespread,''
Wall Street Journal, 2/5/99.
\15\ ``World Health Report on Infectious Diseases: Overcoming
Antimicrobial Resistance,'' (WHO, Geneva, 2000).
\16\ ``Frequently Asked Questions and Answers About Coinfection
with HIV and Hepatitis C Virus'' (CDC, 2002).
---------------------------------------------------------------------------
COMPREHENSIVE AIDS RESEARCH PLAN AND BUDGET
To address these compelling scientific questions, the OAR develops
an annual comprehensive trans-NIH AIDS research plan and budget, based
on the scientific priorities and opportunities that will lead to better
therapies and prevention strategies for HIV infection and AIDS. The
planning process is inclusive and collaborative, involving the NIH
Institutes, as well as eminent non-government experts from academia,
industry, foundations, and AIDS community representatives. The Plan
serves as the framework for developing the annual AIDS research budget
for each Institute and Center, for determining the use of AIDS-
designated dollars, and for tracking and monitoring those expenditures.
The planning process also serves to monitor and assess scientific
progress on an annual basis.
The Plan establishes the NIH AIDS scientific agenda in the areas
of: Natural History and Epidemiology; Etiology and Pathogenesis;
Therapeutics; Vaccines; and Behavioral and Social Science. In addition,
the plan addresses the cross-cutting areas of: Microbicides; Racial and
Ethnic Minorities; Women and Girls; Prevention Science; International
Research; Training, Infrastructure, and Capacity Building; and
Information Dissemination. In consultation with the Director of NIH,
the OAR determines the total annual AIDS research budget. Within that
total, the OAR establishes the AIDS research budgets for each NIH
Institute and Center, in accordance with the priorities and objectives
of the Plan, at each step of the budget development process up to the
Conference Committee. To accomplish this, OAR consults regularly with
the Institute and Center Directors. This process allows the OAR to
ensure that NIH AIDS research funds will be provided to the most
compelling scientific opportunities, rather than a distribution based
solely on a formula.
OAR plays a crucial role in identifying scientific areas that
require focused attention and facilitating multi-Institute activities
to address those needs. OAR fosters this research through a number of
mechanisms, such as designating funds and supplements to jump-start or
pilot program areas, sponsoring workshops or conferences to highlight a
particular research topic, and sponsoring reviews or evaluations of
research program areas to identify research needs.
The overarching priorities that continue to frame the NIH AIDS
research agenda are: prevention research to reduce HIV transmission,
including development of vaccines, microbicides, and behavioral
interventions; therapeutics research to develop simpler, less toxic,
and cheaper drugs and drug regimens to treat HIV infection and its
associated illnesses, malignancies, and other complications;
international research, particularly to address the critical needs in
developing countries; and research targeting the disproportionate
impact of AIDS on minority populations in the United States. All of
these efforts require a strong foundation of basic science, the bedrock
of our research endeavor.
VACCINES AND PREVENTION RESEARCH
Vaccine research remains a critical priority. As a result of
increased NIH funding, many new approaches to HIV vaccines are being
pursued. Although production of candidate vaccines for clinical study
has proceeded slowly, approximately 14 new candidate vaccines will
enter Phase I trials in the next 2 years. Several new combinations of
products, which are expected to provide better immune responses, also
will be tested in Phase I or II trials. The Dale and Betty Bumpers
Vaccine Research Center, located on the NIH campus, recently launched
the first Phase I clinical trial of a multi-clade, multi-gene vaccine
candidate. The development of vaccine candidates also requires
sufficient quantities of non-human primates for preclinical testing.
In addition to vaccines, our biomedical prevention research
priorities include the development topical microbicides; strategies to
prevent mother-to-child transmission, including a better understanding
of risk associated with breast-feeding; and management of sexually
transmitted diseases (STDs). NIH also supports behavioral research
strategies, including interventions related to drug and alcohol use.
Efforts continue to identify the most appropriate intervention
strategies for different populations and sub-epidemics in the United
States and around the world.
NEW CHALLENGES IN THERAPEUTICS RESEARCH
While multiple ART drug combinations continue to successfully
reduce viral load and restore immune responses in many HIV-infected
individuals, these regimens also can result in serious toxicities and
side effects, single- and multiple drug-resistance, and other
complications that make them unacceptable for some individuals. These
side effects and complications appear to be increasing as HIV-infected
individuals continue on drug regimens. More deaths occurring from liver
failure, kidney disease, and cardiovascular complications are being
observed in this patient population. NIH-sponsored research efforts
continue to develop better antiretroviral drugs and treatment regimens
that demonstrate less toxicity, activity in viral and cellular
reservoirs, reduced development of drug resistant virus, improved
pharmacodynamics and pharmacokinetics, easier compliance, and lower
cost.
While the incidence of certain opportunistic infections (OIs) and
malignancies has decreased with the advent of ART, the number of cases
of TB, multiple drug resistant TB, and other coinfections such as
Hepatitis B virus and Hepatitis C virus has increased. The development
of practical and affordable treatment regimens against HIV coinfections
and endemic diseases in developed and developing nations is an NIH
priority.
INTERNATIONAL RESEARCH
NIH bears a unique responsibility to address the urgency of the
global AIDS epidemic. To meet that need, the OAR established an
initiative and strategic plan for global research on HIV/AIDS and has
significantly increased research efforts in the past several years to
benefit resource- and infrastructure-poor nations. NIH supports a
growing portfolio of research conducted in collaboration with
investigators in developing countries. Results of this research benefit
the people in the country where the research is conducted, as well as
people affected by HIV/AIDS worldwide. Critical to the success of these
international studies are foreign scientists who are full and equal
partners in the design and conduct of collaborative studies. To that
end, NIH also supports international training programs and initiatives
that help build infrastructure and laboratory capacity in developing
countries where the research is conducted.
WOMEN AND MINORITIES
Women experience HIV/AIDS differently from men. NIH research has
demonstrated that women progress to AIDS at lower viral load levels and
higher CD4 counts than men. Women also experience different clinical
manifestations and complications of HIV disease. These findings may
have implications for care and treatment of HIV-infected women,
particularly with ART. There are many research questions that remain
unanswered about specific characteristics of women and girls that might
play a role in transmission, acquisition, or resistance to HIV
infection during different stages of the life course.
In many U.S. urban centers, HIV seroprevalence rates mimic those
found in some developing nations. These findings, along with the
resurgence of STDs and associated high-risk behaviors, demonstrate the
need for comprehensive strategies to decrease HIV transmission in
affected vulnerable populations, and improve treatment options and
treatment outcomes. OAR is directing increased resources toward
research to develop new interventions that will have significant impact
on these groups. These include interventions that address the co-
occurrence of other STDs, hepatitis, drug abuse, and mental illness;
and interventions that consider the role of culture, family, and other
social factors in the transmission and prevention of these disorders in
minority communities. NIH is making significant investments to improve
research infrastructure and training opportunities for minorities and
will continue to ensure the participation of minorities in AIDS
clinical trials, as well as in natural history, epidemiologic, and
prevention studies.
SUMMARY
The human and economic toll of the AIDS pandemic is profound,
demanding a unique response that is complex, comprehensive, multi-
disciplinary, and global. The NIH role in this response is fundamental
and unprecedented. The nation's investment in AIDS research is reaping
even greater dividends, as AIDS-related research is unraveling the
mysteries surrounding many other infectious, malignant, neurologic,
autoimmune, and metabolic diseases. The authorities of the OAR allow
NIH to pursue a united research front against the global AIDS epidemic.
We are deeply grateful for the continued support the Administration and
this Committee have provided to our efforts.
______
Prepared Statement of Dr. Francis S. Collins
Mr. Chairman, I am pleased to present the President's budget
request for the National Human Genome Research Institute for fiscal
year 2005, a sum of $492,670,000, which reflects an increase of
$13,842,000 over the fiscal year 2004 Final Conference appropriation.
Following the completion of the Human Genome Project last year, the
National Human Genome Research Institute (NHGRI) of the National
Institutes of Health announced an ambitious plan for applying genomics
to human health benefits. A Vision for the Future of Genomics Research,
the outcome of almost two years of intense discussions with over 600
scientists and members of the public, has three major areas of focus:
Genomics to Biology, Genomics to Health, and Genomics to Society.
Several ambitious projects are already underway to help achieve this
vision including the International Haplotype (HapMap) Project, the
Encyclopedia of DNA Elements (ENCODE), the NIH Roadmap initiative on
Molecular Libraries, and a new Ethical, Legal and Social Implications
(ELSI) Center initiative. As we enter the genomic era, the continued
support of biomedical research in this area is more vital than ever.
ONGOING NHGRI INITIATIVES
International HapMap Project
To study genetic variation more effectively across the human
genome, the NHGRI and a team of partners has launched the International
HapMap Project. The goal of the project is to determine the common
patterns of DNA sequence variation in the human genome, and to make
this information freely available in the public domain. This
international consortium is developing a map of these patterns across
the genome by determining the genotypes of one million or more sequence
variants in DNA samples from populations with ancestry from Africa,
Asia, and Europe. When complete, the HapMap will enable the discovery
of sequence variants that affect common disease, the development of
diagnostic tools, and the ability to choose targets for therapeutic
intervention. Detailed information about the HapMap project was
published in a landmark article in Nature, and updated details can be
found on the web at www.hapmap.org.
Comparative Genomics to Understand the Human Genome
One of the most powerful approaches for unlocking the secrets of
the human genome is comparative genomics. While the completed sequence
of the human genome represents a milestone of historic proportions, a
daunting challenge that still lies ahead is to interpret its biological
meaning and function. Recently sequenced genomes of the mouse, rat, and
a wide variety of other organisms--from yeast to chimpanzees--prove
that the genomes of other species are amongst the most powerful tools
in advancing understanding of the human genome. The current NHGRI-
supported, large-scale sequencing centers have built a prodigious
capacity for, and expertise in, sequencing entire genomes. The combined
capacity of these centers is expected to yield the equivalent of about
20 additional draft vertebrate genomes in just the next three years.
These additional species sequences will provide exciting new insights
into the function of the human genome, and will assist genome
scientists in translating the basic findings of the Human Genome
Project into tangible applications, including the diagnosis,
prevention, and treatment of disease.
ENCODE--ENCyclopedia Of DNA Elements
To understand the meaning of the human instruction book, the
genome, the identities and precise locations of all functional elements
must be determined. Thus, the NHGRI has launched the ENCyclopedia Of
DNA Elements (ENCODE) project to identify these elements
comprehensively. The ENCODE project seeks to characterize the tools
needed for exploring genomic sequence, improve those tools when
necessary, and define a clear path for the determination of all of the
functional elements in the entire human genome. On October 9, 2003, the
NHGRI announced the first ENCODE grants in a three-year, $36 million
project (www.genome.gov). ENCODE begins as a pilot effort to evaluate
methods for the exhaustive identification and verification of
functional sequence elements in a carefully selected 30 million base
pairs, or about one percent, of human genomic DNA. This will require
access to information, resources, ideas, expertise, and technology
beyond the capabilities of any single group. Therefore, a consortium of
investigators with diverse backgrounds and expertise will work
cooperatively to carry out this project to: (1) evaluate rigorously the
relative merits of a varied set of computational and experimental
techniques, technologies, and strategies for identifying the functional
elements in human genomic sequence, and (2) test the capabilities of
such methods to scale up efficiently to allow, ultimately, analysis of
all the functional elements encoded in the entire human genome
sequence.
Centers Of Excellence In Genomic Science (CEGS)
The NHGRI Centers Of Excellence In Genomic Science (CEGS) program
has been in place for four years. This program is a centerpiece of the
Institute's effort to stimulate new interdisciplinary approaches to
genomic research and technology development. A total of about 10 CEGS
grants are ultimately expected to be funded. These will generally be
five-year awards of up to $3 million per year. Seven awards have been
made to date; each involves multiple investigators and disciplines, and
several cut across departments and institutions. A grantee meeting in
October 2003 stimulated new collaborations and identified ways to share
CEGS grant data and resources with the larger research community.
Clinical Research Activities in the NHGRI Intramural Program
Research efforts of NHGRI Division of Intramural Research (DIR)
investigators are aimed at deciphering the genetic contributions to
common disorders, to provide a better understanding of diseases such as
cancer, diabetes, and heart disease, as well as to a number of less
common but equally debilitating afflictions. DIR investigators have
been at the forefront of scientific innovation, developing a variety of
research approaches that accelerate the understanding of the molecular
basis of disease. These include the development of DNA microarray
technologies for large-scale molecular analyses, innovative computer
software to study fundamental biological problems, animal models
critical to the study of human inherited disorders, and the clinical
testing of new therapeutic approaches for genetic disease. Three
examples of gene discoveries within the past year include the gene
responsible for Hutchinson-Gilford progeria syndrome, the disease
causative gene for Charcot-Marie-Tooth disease type 2D, and a gene
variant that contributes to the risk of type 2 diabetes. These and
other advances should ultimately lead to improved diagnostic,
prevention, and treatment strategies having a direct impact on human
health.
NEW INITIATIVES
The NHGRI is very enthusiastic about the initiatives included in
the NIH Roadmap and is deeply involved in implementation plans for
several of the projects embodied in the ``New Pathways to Discovery''
theme.
Molecular Libraries
As part of its Vision for the Future of Genomics Research, and in
partnership with many other NIH Institutes as part of NIH's new Roadmap
for Medical Research, the NHGRI is taking a lead role in providing
access to high throughput screens for small organic molecules to public
sector researchers. These small molecules can be used as chemical
probes to study cellular pathways in great depth and will broadly
enable public and private biomedical research into basic biology and
accelerate the validation of new therapeutic targets, and thus the
discovery of new drugs. For this effort to provide maximal benefits,
the library of small molecules must contain a sufficient number of
compounds. To build such a library, a network of six national centers
will establish a common collection of 500,000 or more chemically
diverse small molecules, of both known and unknown activities.
Investigators who develop assays suitable for high throughput screening
will apply for access to these centers. After peer review, suitable
assays will be run through a screen of 500,000 or more compounds, and
the positives subjected to a first pass of chemical optimization to
generate useful compounds. We anticipate that this new resource will
catalyze a genuine paradigm shift, because it will give academic
investigators a new and powerful research tool not previously at their
disposal.
$1,000 Genome Sequence
Current sequencing costs are too high to collect the quantity and
quality of soome sequences optimal for research and clinical
applications. Completely sequencing the genomes of many individuals
would greatly advance understanding of the role of DNA sequence
variation in human health, but using DNA sequence information for care
of individuals is not possible at current costs. Thus, NHGRI has
launched an aggressive program to develop technologies to lower the
cost of DNA sequencing dramatically. The goal for the first five years
of this program is to develop the capability to produce a high quality
draft sequence for a large, complex (e.g., mammalian) genome for
$100,000. The goal of the second phase, which is estimated to take ten
years, is producing a genome sequence for $1,000. Once achieved, a
$1,000 genome analysis would be of great use to correlate DNA
information with health outcomes. This includes determining genes in
each individual that predispose that individual to specific diseases,
and assessing which drugs are likely to elicit adverse reactions in
each individual, so that drugs can be used more effectively and with
fewer side effects.
Centers for Excellence in ELSI Research
The NHGRI Ethical Legal and Social Implications (ELSI) research
program recently released a Request for Applications inviting proposals
for the development of Centers of Excellence in ELSI Research (CEER).
The CEER program is designed to support the development of groups that
will pursue research questions best approached through intensive and
extended collaboration among investigators from multiple disciplines,
using diverse methodologies. CEER investigators are encouraged to
consider new ways to explore these questions, design innovative and
efficient research projects, propose and disseminate health or social
policy options based on Center research, and, when feasible, facilitate
policy development pertinent to a specific issue. Center applicants are
particularly encouraged to identify cutting edge research topics and
approaches that may lead to high payoff solutions to important ELSI
problems.
Intramural Social and Behavioral Research Branch
The NHGRI has formed a new Social and Behavioral Genetics Research
Branch within its intramural research program. The main focus of the
Branch is to conduct research on the social and behavioral aspects of
translating genomic discoveries into improved health. The Branch will
also: (1) study innovative ways of applying genetic discoveries to
promote health and well-being; (2) apply social, behavioral, and
communication theories to understand how to communicate genetic risk
effectively; (3) develop and refine evidence-based methods of
communicating genetic risk to individuals, families, communities, and
populations; (4) seek to understand how social factors influence
genetic discoveries and research; and (5) investigate the ethical and
public policy implications of genetic research and the use of genetics
in clinical practice.
OTHER AREAS OF INTEREST FOR NHGRI
Genetic Discrimination
The NHGRI remains concerned about the risk of genetic
discrimination and supports the President's call for federal
legislation. Many Americans are worried that insurers and employers may
use genetic information to deny, limit, or cancel their health
insurance or to discriminate against them in the workplace. A total of
41 States have enacted legislation on discrimination in health
insurance and 31 have enacted legislation on workplace genetic
discrimination. However, only comprehensive federal legislation can
guarantee everyone in the United States protection from genetic
discrimination. Last October, the full U.S. Senate voted unanimously
(95-0) in favor of the ``Genetic Information Nondiscrimination Act of
2003'' (S. 1053), which would address this problem. It is hoped that
the House will soon take similar steps.
Intellectual Property Rights in Genetics and Genomics Research
NHGRI has long worked on issues of intellectual property related to
genetic and genomic data. The NHGRI ELSI program plans soon to issue a
new initiative to encourage studies of the role of intellectual
property rights in genetics and genomics research, as well as the
impact of exclusivity on progress in these fields. The initiative will
support legal, economic, political science, and statistical analyses
and empirical investigations of theories and practices of rights
holders, stakeholders, and researchers in genetics and genomics
research and development, with the specific goal of helping build the
research base necessary to inform the rational development of future
policy options regarding intellectual property in genetics, and
genomics.
The NHGRI, with several other NIH Institutes, has recently provided
funds for a National Academy of Sciences' study, ``Intellectual
Property in Genomic and Protein Research and Innovation.'' This 18-
month study, involving experts from law, public policy and genomics,
will address such important questions as: What is the impact of
intellectual property and licensing on genetic and proteomic research?
What policy options should be considered in this area? How have other
regions of the world addressed these issues? It is hoped that this
study will provide insights on how to address the thorny issues
surrounding the interface of intellectual property, biomedical
research, and patient care.
Direct-to-Consumer Marketing of Genetic Tests
Marketing of products or services that promise to provide consumers
with genetic insights into personal health has proliferated
dramatically in recent years. NHGRI's intramural Division of Bioethics
has systematically studied this issue. So far, researchers have found
that many direct-to-consumer (DTC) advertisements exaggerate the
scientific basis of claims made and/or fail to communicate effectively
the current limitations of the specific genetic knowledge discussed. In
particular, the Internet has provided a powerful medium for the
construction of ``informational'' resources through which DNA analysis
is often linked to a claim to individualize consumer profiles for
specific products available through the website. Additionally, the
first example of a multi-media DTC advertising campaign for a genetic
test, the BRCA1/2 test, was piloted in two metropolitan areas in the
last year. The NHGRI recently held a workshop to assess DTC marketing
of genetic tests, and considered the scope of the practice and possible
policy options. The NHGRI will work with the Secretary's Advisory
Committee on Genetics Health and Society on this issue.
Trans-NIH Obesity Initiative
The NHGRI Deputy Director represents the Institute on the trans-NIH
obesity working group. We believe that this initiative is vitally
important, and that the genomic tools produced by the Human Genome
Project can be of considerable utility in discerning the role of genes
and environment in causing obesity, and in predicting which obese
individuals will develop which diseases.
CONCLUSION
With the completion of the human genome sequence, we have fully
entered the genomic era. The NHGRI has now spearheaded many specific
and innovative initiatives to understand how genetics affects human
health, the ultimate motivation for the Human Genome Project. The most
interesting and important applications of genomics lie not behind us,
but ahead of us. Continued investment by the Congress in genetic/
genomic research is vital to our efforts to enhance the health of all.
______
Prepared Statement of Dr. Richard J. Hodes
Mr. Chairman and Members of the Committee: The NIA is requesting an
fiscal year 2005 budget of $1,055,666,000, an increase of $31,068,000
or 3 percent over the comparable fiscal year 2004 appropriation.
Thank you for this opportunity to participate in today's hearing. I
am Dr. Richard Hodes, Director of the NIA, and I am pleased to be here
today to tell you about our progress making and communicating
scientific discoveries that will improve the health and well-being of
older Americans.
There are today approximately 35 million Americans ages 65 and
over, according to the U.S. Bureau of the Census. Thanks to
improvements in health care, nutrition, and the overall standard of
living, these men and women are more likely than ever before to be
healthy, vigorous, and productive: Studies confirm that disability
among America's elders has declined steadily over the past decade. More
older Americans are able to participate in ``instrumental activities of
daily living,'' such as performing household chores and managing their
own medications, while fewer are experiencing limitations in basic
physical tasks such as walking or climbing stairs.
At the same time, diseases of aging continue to affect many older
men and women, seriously compromising the quality of their lives. For
example, more than half of all Americans over age 65 show evidence of
osteoarthritis in at least one joint. Over half of Americans over age
50 have osteoporosis or low bone mass. Cardiovascular disease, cancer,
and diabetes remain common among older Americans. And as many as 4.5
million Americans suffer from Alzheimer's disease (AD), the most common
cause of dementia among older persons.
The mission of the National Institute on Aging is to improve the
health and well-being of older Americans through research. In support
of this mission, the Institute conducts and supports an extensive
program of research on all aspects of aging, from the basic cellular
and molecular changes that occur as we age, to the prevention and
treatment of common age-related conditions, to the behavioral and
social aspects of growing older, including the demographic and economic
implications of an aging society. In addition, the NIA is the lead
federal agency on Alzheimer's disease research; our activities in that
area encompass prevention, detection, clinical trials, and caregiver
issues. Finally, our education and outreach programs provide vital
information to older people across the United States on a wide variety
of topics, including living with chronic conditions such as arthritis
or diabetes, caring for a loved one with Alzheimer's disease, and
maintaining optimal health through exercise.
The NIA works to rapidly translate research findings into practical
interventions and information that will benefit older Americans. This
may involve enhancing our methods of communicating important research
findings to physicians or the public; creating opportunities for
patients to benefit from groundbreaking research through participation
in clinical trials; or even recognizing the potential of a very basic
finding in a mouse, a worm, or a molecule to eventually have a powerful
impact on the public health.
For example, recent findings in C. elegans, a tiny worm that is
frequently used for genetic studies, are providing important insights
about fat regulation and storage that may lead to improved
understanding of overweight and obesity in humans. NIH-supported
researchers used RNA interference (RNAi), a technique in which genes
are inactivated one at a time to determine their function, to screen
the worm's genome and found some 417 genes involved with fat regulation
and storage. Many of the genes they found have human counterparts, a
number of which had not been previously implicated in the regulation of
fat storage. Overweight and obesity are widespread in the United States
and are associated with an array of health problems, including heart
disease, stroke, osteoarthritis, adult-onset diabetes, and certain
types of cancer; the genes identified in C. elegans may ultimately
suggest new targets for treating human obesity and its associated
diseases.
Another recent basic discovery, this one in mice, may have profound
implications on the field of reproductive biology. Since the 1950s,
scientists have believed that women are born with all the oocytes
(eggs) they will ever have, and that these eggs die off as a woman
ages, with fertility diminishing and, at menopause, disappearing as a
result. However, NIH-supported researchers recently found that oocyte-
containing follicles continue to develop in the ovaries of adult mice.
If this finding is confirmed--and extended to humans--it could lead not
only to new treatments for premature ovarian failure (which affects
some 250,000 American women under age 40, according to the National
Institute of Child Health and Human Development), but also to
interventions to delay menopause and extend fertility.
NIA-supported investigators in all fifty states are conducting
research that is changing the way we prevent, diagnose, and treat the
diseases of aging. NIA also supports networks of centers that focus on
specific topics, including demography and the basic biology of aging.
There are currently 29 NIA-supported Alzheimer's Disease Centers
(ADCs), at which investigators are working to translate research
advances into improved care and diagnosis for AD patients while
focusing on the program's long-term goal--finding ways to treat and
possibly prevent AD. Many ADCs have satellite facilities that offer
diagnostic and treatment services and collect research data in
underserved, rural, and minority communities. Another type of Center,
the Edward R. Roybal Centers for Research on Applied Gerontology,
translates behavioral and social research findings into practical
outcomes for older adults. Each of the six Roybal Centers addresses one
or more central themes (e.g., cognitive influences on physician/patient
interaction affecting medical compliance; safe driving behavior; social
role adjustment upon retirement).
The NIA also supports a variety of clinical trials, frequently in
collaboration with one or more NIH Institutes or other organizations.
For example, NIA is currently supporting 25 AD clinical trials, seven
of which are large-scale prevention studies. These trials are testing
agents such as anti-inflammatory drugs and anti-oxidants for their
effects on slowing progress of the disease, delaying AD's onset, or
preventing the disease altogether. Other intervention trials are
assessing the effects of various compounds on the behavioral symptoms
(agitation, aggression, and sleep disorders) of people with AD. In
addition to AD, NIA supports clinical trials for a number of other
conditions, including cardiovascular disease, Parkinson's disease, and
certain types of cancer.
A major clinical trial in which NIA-supported researchers took part
is the Diabetes Prevention Program, a multi-institutional study that
was initiated by the National Institute on Diabetes and Digestive and
Kidney Diseases and was designed to identify interventions that could
prevent or delay the development of type 2 diabetes. The researchers
found that people who are at high risk for diabetes can sharply reduce
their risk by adopting a low-fat diet and moderate exercise regimen.
This effect was most pronounced among study participants age 60 and
over. Treatment with the drug metformin (Glucophage) also reduced
diabetes risk among study participants, but for unknown reasons was
less effective among older participants. With other participating NIH
Institutes, we are continuing to follow the study participants to
determine long-term effectiveness of these interventions.
The NIA also has a number of ongoing or planned special initiatives
on diverse research topics. These include:
Health Disparities.--The NIA's Healthy Aging in Neighborhoods of
Diversity Across the Lifespan (HANDLS) project is a community-based
study of health disparities among different racial, ethnic, and
socioeconomic groups in Baltimore. The purpose of HANDLS is to
disentangle the effects of race and socioeconomic status on risk
factors for morbidity and mortality, incidence and progression of pre-
clinical disease, development and persistence of health disparities,
longitudinal health status, and health risks. The pilot phase of the
study was completed in December 2001, and the full-scope study is now
being planned for implementation in 2004-2005. Unique to the HANDLS
study is the use of two fully-equipped mobile research laboratories
that enable investigators to collect data directly in the neighborhoods
under study, establishing links with the community and increasing both
the interest of potential participants and the retention rate.
Neuroimaging.--The NIA is developing an Alzheimer's Disease
Neuroimaging Initiative, a longitudinal, prospective, natural history
study of normal aging, mild cognitive impairment, and early AD to
evaluate neuroimaging techniques such as magnetic resonance imaging
(MRI) and positron emission tomography (PET). The study objectives are
to:
--Identify the best markers for early diagnosis of AD
--Identify markers for following disease progression and monitoring
treatment response
--Develop surrogate endpoints for clinical trials
--Decrease time and expense of drug development
--Establish methods for the collection, processing, and distribution
of neuroimaging data in conjunction with other biological,
clinical, and neuropsychological data
The initiative is planned as a partnership among the NIA/NIH,
academic investigators, the pharmaceutical and imaging equipment
industries, the Food and Drug Administration, the Centers for Medicare
and Medicaid Services, and the NIH Foundation, with participation from
the Alzheimer's Association and the Institute for the Study of Aging.
The clinical, imaging, and biological data and samples will be made
available, with appropriate safeguards to ensure participant privacy,
to scientific investigators in the academic and industrial research
communities.
Testosterone replacement in men.--Levels of circulating
testosterone decline as men age, and this decline may be related to
decrements in physical and cognitive functioning--for example, recent
research suggests that older men with lower levels of free, or unbound,
testosterone circulating in their bloodstreams could be at increased
risk of developing Alzheimer's disease (AD). Increasingly, middle-aged
and older men are turning to testosterone replacement therapy (TRT) to
forestall these symptoms: In 2002, over 800,000 men received some form
of testosterone replacement. However, as with the use of hormone
replacement therapy among women prior to the release of the Women's
Health Initiative results demonstrating serious HRT-related risks, men
are using TRT in the absence of clear scientific data supporting its
use. A multi-disciplinary panel, led by the Institute of Medicine and
supported by the NIA and the National Cancer Institute, recently
evaluated the pros and cons of conducting clinical trials of
testosterone replacement therapy in older men to answer many of the
lingering questions about the effects of this hormone in the aging
body. The NIA is considering the IOM recommendations very carefully and
will act on the recommendations to begin clinical trials to determine
the efficacy of testosterone in treating symptomatic older men with low
testosterone levels.
Genetics.--The NIA has established a new AD Genetics Initiative, a
program to accelerate the pace of AD genetics research by creating a
large repository of DNA and cell lines from families with multiple AD
cases. The goal of this initiative is to develop strategies for
identifying the remaining late-onset AD (LOAD) risk factor genes,
associated environmental factors, and the interactions of genes and the
environment. The NIA's AD Genetics Initiative will intensify sample
collection and encourage data sharing by providing access to the
repository to qualified investigators. To date, several well-integrated
components of the Genetics Initiative have been launched. Mechanisms to
efficiently identify and share large numbers of samples for AD genetic
analysis have been developed through the recently-enlarged National
Cell Repository for AD (NCRAD), and eighteen of the NIA's Alzheimer's
Disease Centers have received supplemental funding to recruit new
family members participation. Uniform standards for sample collection
have also been developed. As of late January, over 200 families have
been evaluated and enrolled, and over 800 blood samples have been
logged at NCRAD. A clinical task force has been established which is
helping to determine the correct phenotypic data to be included with
the biological samples. A major goal is the long-term follow-up of
individuals participating in the study.
In order to publicize the initiative, the NIA Office of
Communications and Public Liaison, together with its Alzheimer's
Disease Education and Referral Center, Columbia University, and NCRAD,
partnered with the Alzheimer's Association to conduct focus groups and
develop publicity materials to help recruiting efforts. These publicity
materials, including a workbook, CD ROM, fact sheet, and brochure were
distributed at the a recent meeting of the ADCs and will now be sent to
ADCs and Alzheimer's Association chapters to help recruiting efforts.
Longevity.--The NIA has formed a Longevity Consortium to help
identify and understand genetic and other factors that predispose to
human longevity or protect against multiple age-related conditions, a
major goal in aging research. The Consortium is an innovative system
for expeditious generation, review, and funding of new projects as
opportunities arise, and includes epidemiologists, geneticists,
population biologists, statisticians, and others with an interest in
the genetic and molecular basis for longevity. Participants can draw on
the study populations of 15 of the largest human aging studies,
including the Cardiovascular Health Study, the Women's Health
Initiative, Health ABC, the Study of Osteoporotic Fractures, the
Rotterdam Study, the Honolulu Heart Study, and the New England
Centenarian Study. Altogether, Consortium researchers will have access
to data on some 200,000 study subjects.
Demography.--As the percentage of Americans over age 65 increases,
profound societal changes will likely occur. NIA-supported researchers
are exploring the changing demographic, social, and economic
characteristics of the older population. Research embraces topics such
as: trends in the age-structure of populations; changes in levels of
disease and disability; economic costs of disability; cost-
effectiveness of interventions; migration and geographic concentrations
of the elderly; decision-making about retirement; pensions and savings;
the relationship between health and economic status; and health
disparities by gender and race. The results of this research often have
important implications for public policy. Such research often involves
large datasets that are frequently co-sponsored by NIA and other
government agencies in the United States and overseas. These include:
--Health and Retirement Study, a biennial survey of more than 22,000
Americans over age 50, which provides data for researchers,
policy analysts, and program planners who are making major
policy decisions that affect retirement, health insurance,
saving and economic well-being.
--National Long-Term Care Study, which explores trends in the
prevalence of self-rated old age disability and physical,
cognitive, and sensory limitations.
--Longitudinal Study of Aging, a long-term study in which the NIA
participates with the National Center for Health Statistics.
--Panel Study of Income Dynamics, begun in 1968 and conducted by the
National Science Foundation, is a nationally representative
longitudinal study that collects information on U.S.
households. Notably, the PSID contains information on
approximately 5,000 heads of households and spouses who are
baby boomers (born 1945-1964)--a cohort not yet represented in
the Health and Retirement Study (HRS). Continued data from the
PSID will shed light on individual household saving behavior of
the baby boom generation and its neighboring age cohorts.
Health Communication.--Communication of research-based health
information is another key activity of the NIA, and the Institute uses
both traditional and innovative means to disseminate information. In
2003, the Pew Internet and American Life survey found that 22 percent
of Americans age 65 or older have access to the Internet, and that 58
percent of these ``wired seniors'' had used the Internet to look for
information about a specific disease. However, NIA-supported research
has demonstrated that with age come changes in cognition (such as
working memory, perceptual speed, text comprehension) and vision
(including loss of ability to detect fine details, less light reaching
the retina, and loss of contrast sensitivity) that could hinder the
older person's ability to use the Internet easily and effectively. To
respond to the unique needs of Internet users over 60, the NIH launched
NIHSeniorHealth.gov on October 23, 2003. Developed by the NIA and the
National Library of Medicine, and featuring content developed in
collaboration with several other NIH Institutes, this web site is easy
for older adults to read, understand, remember, and navigate. For
example, the site features large print and short, easy-to-read segments
of information repeated in a variety of formats--such as open-captioned
videos and short quizzes--to increase the likelihood it will be
remembered. Consistent page layout and prompts help users move from one
place to another on the site without feeling lost or overwhelmed. The
site also has a ``talking'' function, which allows users the option of
reading the text or listening to it as it is read to them.
The risk of many diseases increases with age, so the site focuses
on health topics or specific diseases that are of particular interest
to older people, including Alzheimer's disease, Alzheimer's disease
caregiving, arthritis, balance problems, breast cancer, colorectal
cancer, exercise for older adults, hearing loss, lung cancer, and
prostate cancer. Upcoming and planned topics include complementary and
alternative medicine, diabetes, falls, shingles, vision changes, and
others. Each topic provides general background information, quizzes,
frequently asked questions (FAQs), open-captioned video clips,
transcripts for the videos, and photos and illustrations with captions.
From its launch in October 2003 through late January,
NIHSeniorHealth.gov has received over a million page views and been
visited by nearly 118,000 unique visitors.
The NIA also maintains a large selection of lay-language Age Pages,
which cover an array of topics relevant to older people and include
information on a number of diseases and conditions, suggestions for
coping with these conditions, and information on other resources. Most
of the Age Pages have been translated into Spanish.
At a March 2002 hearing of this Committee entitled ``Bench to
Bedside,'' Chairman Regula recommended that NIA and the Administration
on Aging (AoA) work together to disseminate research-based consumer
education to the thousands of seniors who participate in the Meals-on-
Wheels program across the Nation. In response, NIA staff, with the
participation of AoA, have conducted focus groups of program managers
from the Meals on Wheels Association of America (MOWAA) to determine
the types of information of greatest interest to MOW's clients, as well
as the best ways to deliver such information (e.g., meal tray liners
printed with key health messages, articles for MOWAA newsletters, or
specially crafted Age Pages.) Based on focus group feedback, NIA is
currently revising Age Pages on diabetes, alcohol, and depression;
these materials will be tested at the upcoming MOWAA meeting in
September 2004, and we anticipate that distribution to MOWAA clients
will begin shortly thereafter.
The Alzheimer's Disease Education and Referral (ADEAR) Center has
been compiling and disseminating information about AD for health
professionals, persons with AD and their families, and the public since
1990. NIA is also working to translate research findings into action
through its highly successful campaign to encourage older people to
exercise. In the last four years, NIA has distributed over 611,000
copies of its exercise guide and 93,000 copies of its companion video
to the public. A Spanish-language version of the guide was published in
January 2002, and over 33,500 copies have been distributed to date. The
NIA's efforts to promote exercise and strength training are conducted
in support of the President's ``HealthierUS'' and the Department of
Health and Human Services' ``Steps to a HealthierUS'' initiatives.
______
Prepared Statement of Dr. Andrew C. von Eschenbach
BUDGET STATEMENT
The fiscal year fiscal year 2005 budget includes $4,870,025,000, an
increase of $134,052,000 over the fiscal year 2004 enacted level of
$4,735,973,000 comparable for transfers proposed in the President's
request.
2015 CHALLENGE GOAL
The Nation's unwavering support of cancer research has enabled the
National Cancer Institute (NCI) and our many partners throughout the
cancer research community to make enormous strides over the past three
decades. Our understanding of cancer as a disease process, and the
associated opportunities to prevent, detect early and successfully
treat it has improved dramatically. However, even in the face of this
progress, the magnitude of the cancer burden means that the disease
still affects nearly every family in America. This year, approximately
1.4 million of our citizens will face a cancer diagnosis, and over
560,000 of our citizens--about 1,540 each day--will die from their
disease. Furthermore, the fact that cancer occurs primarily in
individuals over the age of 50 means that more of our citizens will
suffer the terrible burden of this disease in the next 10-20 years due
to the aging and changing demographics of our population.
Fortunately, the convergence of science and advanced technologies
is changing our perceptions of what is possible. In fact, we are
entering a period in biomedical research where progress in cancer
research can be exponential--an inflection point. Last year I informed
this committee that ``our nation's investment in basic research has
fueled the engine of discovery, which is rapidly illuminating the
cumulative genetic changes and associated molecular mechanisms that
ultimately produce cancer.'' As I said then and I reiterate now ``for
the first time, we have within our grasp the ability to design target-
specific interventions to preempt this process.'' Based on the current
astounding pace of progress in cancer research and the transformational
effects of advanced biomedical technologies, I am even more fervent in
my belief that we can achieve this vision.
To capitalize on this inflection point, I have set forth an
ambitious challenge goal for the NCI, and for the entire cancer
research and care community: to eliminate suffering and death from
cancer by 2015. This ``stretch goal'' is intended to unify and focus
our thinking, strategies, and actions in new ways that will optimize
the use of our resources and accelerate progress against cancer. This
challenge also presents new opportunities for the NCI to provide
leadership for our Nation's effort to conquer cancer, especially in the
development of the new synergies and partnerships needed to achieve
this bold vision.
Recent progress across nearly all of biomedical research has set
the stage for unimagined progress in biomedicine early in the 21st
century. Thanks to research, we now understand that cancer is a disease
process--where normal cells are transformed into cancer cells through a
series of defined steps that begin with a simple change in the genetic
material. If left unchecked, these transformed cells can progress and
spread to cause the suffering and death that we recognize as the
horrific burden of cancer. Thankfully, our growing understanding of
this process has revealed multiple opportunities to intervene. These
new intervention strategies include preventing initiation of the
process; detecting it early when it is most amenable to elimination;
and arresting the process to stop the spread (metastasis), which is the
primary reason that patients suffer unduly and die from their disease.
In short, we are rapidly learning how to ``preempt'' the cancer disease
process. We believe in the next few years that new intervention
strategies will allow us to prevent and/or eliminate many cancers--and
ultimately transform cancer into chronic, manageable diseases that
patients live with--not die from.
Scientific advances and major discoveries from areas such as
genomics, nanotechnology, proteomics, immunology, and bioinformatics
allow us to envision a not too distant future when a patient's genetic,
lifestyle, and environmental risk for cancer can be combined with
effective prevention and early intervention strategies especially for
those at high risk. Serum genomic and proteomic patterns, and advanced
imaging technologies, will be employed to detect cancers at the
earliest stages. Precise molecular diagnosis and patient-specific
prognostic profiling will allow physicians to predict response to
specific interventions and provide a rational basis for tailoring
therapies. The result will be more efficacious and less toxic, targeted
agents delivered to patients. Achieving these outcomes will result in
the preemption of a great deal of cancer. I believe that this is no
longer a dream but an achievable reality.
To achieve the 2015 challenge we must take the steps necessary to
accelerate the pace of progress across the entire cancer research
continuum. The basic research which is aimed at discovering the
pathways that lead to cancer represents the beginning of a continuum
that proceeds through development of new agents and technologies and
ultimately to the delivery of these new interventions to patients.
Using our ever increasing knowledge of the molecular defects in cancer
cells and the biomarkers that define the cancer process will enable the
development of the new targeted interventions we need to prevent,
detect, and treat cancer.
To achieve this acceleration the NCI has identified six ``mission-
critical'' research areas that we believe will offer significant
potential for near term progress against cancer. These include:
harnessing the power of the newly emerging science of molecular
epidemiology to better identify risk populations; developing an
integrative understanding of cancer (systems) biology to discover key
biomarkers and targets; facilitating the development of ``strategic''
cancer interventions for targeted prevention, early detection, and
treatment; creating a national integrated clinical trials system to
more effectively test these interventions; overcoming health
disparities to deliver these advances to those in greatest need; and
developing a bioinformatics network to connect the cancer research
community and optimize the collection, analysis, and use of the
enormous amount of data and knowledge that must be managed and shared.
CANCER BIOMEDICAL INFORMATICS GRID (CABIG)
In this past year's Appropriations Committee Report, NCI was
requested to explore ways in which information could be better shared
among researchers and cancer care deliverers. In early 2004, the NCI
responded by launching an unprecedented program to connect cancer
researchers through an advanced technology platform called the Cancer
Biomedical Informatics Grid (caBIG). This pilot initiative has the
potential to transform the pace of cancer research by providing the
tools needed to share information and data. caBIG will be developed by
connecting 50 of our NCI-designated cancer centers through an NCI-
developed open source system which will in effect become the ``World
Wide Web'' of cancer research. This platform which integrates with the
NIH Roadmap informatics initiative will link individual cancer
researchers and research institutions across the nation, and around the
world, in an open source, federated network that will enable
researchers to share tools, standards, data, computing applications,
and technologies. This unprecedented bioinformatics system will
facilitate the collection, storing, searching, analysis,
classification, management, and archiving and retrieval of research
data. caBIG will improve the quality of data, provide unimagined access
to heretofore limited databases, increase the pace of cancer research
and enhance the effectiveness of our investments in cancer research.
caBIG has the capability to virtualize cancer research.
caBIG leverages the unique resources and capabilities of NCI's
cancer centers to meet the needs of the broad cancer research and care
communities. The cancer centers, along with NCI's platforms for
translational research, the Specialized Programs of Research Excellence
(SPORES), are our partners in this strategic effort to ensure that the
fruits of fundamental scientific research can be rapidly captured for
the benefit of cancer patients. This is an example of how the future
can be transformed if we can successfully integrate advanced
technologies across the discovery, development, and delivery research
continuum. In this instance the whole will be a great deal more than
the sum of the parts.
NATIONAL ADVANCED BIOMEDICAL TECHNOLOGY INITIATIVE
In developing strategies to optimize progress in NCI's high
priority research areas, it became clear that we must proactively
identify, develop, and deploy advanced biomedical technologies, such as
bioinformatics, across the entire cancer research continuum. This
concept represents a critical new element of our overall strategy to
achieve the 2015 challenge goal; however, there is clearly a gap
between our current level of capabilities in advanced technologies and
what is needed. I believe that we now have the opportunity to address
this gap through the creation of an unprecedented national advanced
biomedical technology initiative that will be transformational for
cancer and other diseases.
Achieving our challenge goal will require that we fully integrate
advanced ``enabling'' technologies with the cancer research and care
enterprise. Advanced technologies represent those new tools and
approaches that enable new approaches to the challenging problems of
detecting, controlling, and preventing cancer. Advanced technologies
allow cancer researchers to generate, collect, and analyze vast amounts
of data, and to pursue innovative approaches that could not be
accomplished without these sophisticated tools. As illustrated by our
efforts in bioinformatics, the NCI is providing leadership in the
development and integration of advanced technologies and we are also
building the cross-disciplinary teams needed to implement these new
strategies.
Providing advanced technology platforms to scientists working in
cancer research is one of our highest priorities at the NCI; and to
that end, we have undertaken a cancer-enterprise wide planning effort
to develop a national advanced technology initiative for cancer. In
planning for this initiative, the NCI has identified (in addition to
bioinformatics) multiple areas of advanced technology development that
will be crucial in building this national resource. Examples of cross-
cutting capabilities, which will support the range of strategic
research priorities that we have identified as pivotal areas for
progress, include: advanced imaging; biomarkers and proteomics;
nanotechnology; and development capabilities such as scale-up for new
cancer therapies and prototyping for new diagnostics devices.
We have made significant progress in cancer diagnosis and treatment
based on static imaging of the body's organs provided by x-ray, CT,
PET, and MRI. The new generation of advanced imaging technologies will
target specific molecules and cells. We will be able monitor cellular
processes to assess the effectiveness of experimental treatments and to
define cancer cells at their earliest stages. Nanotechnology will
provide opportunities to develop biosensors that have the capability of
detecting changes in cells at the earliest stages of cancer and
``report'' back on them. This breakthrough technology will also
facilitate the design of new technologies to probe cell functions,
measure cellular events with unimagined precision, and specifically
deliver molecular entities to attack cancer. The combination of
advanced imaging and nanotechnology offers the promise of realizing
these advances to achieve the exponential progress that is possible at
the current inflection point.
The post-genomics era in cancer research has produced vast amounts
of information aout the genetic basis of cancer, but perhaps of more
importance, we are learning that the functioning of normal and tumor
cells is controlled by the proteins that are transcribed from these
abnormal genomes. These proteins, along with genes and other indicators
of the processes and pathways that distinguish cancer, are called
biomarkers. Through the use of advanced technologies NCI is developing
innovative strategies to discover and validate biomarkers for use in
clinical applications. Biomarkers, along with advanced imaging,
nanotechnology, and other advanced technology platforms, will comprise
an unprecedented National Advanced Biomedical Technology Initiative for
Cancer (NABTIc).
This initiative is a major element of our strategy to achieve NCI's
challenge goal to eliminate suffering and death due to cancer by 2015.
The NABTIc would leverage and align the capabilities and resources in
advanced technology development across the nation--and gain strength
from all sectors. Through a network of technology ``nodes'' it would
capitalize on capabilities in our cancer centers and SPORES and
optimize the deployment of NCI's existing strengths in advanced
technologies that currently exist at our Frederick campus. This
initiative is currently being refined and further developed with the
aid of our advisors and partners in the extramural community, and a
plan to purse this concept is under development.
STRATEGIC PARTNERSHIPS
Finally, to implement many elements of our strategic plan, we will
partner broadly With all of the sectors that comprise the cancer
community, including other federal agencies and private industry. The
NCI is an active partner with many federal agencies, including the
Department of Defense, the Veterans Administration, the Centers for
Disease Control and Prevention, the Agency on Healthcare Research and
Quality, and the Centers for Medicare and Medicaid Services. One
partnership that is critically important to optimizing the pace at
which laboratory discoveries progress to become new interventions for
cancer is our alliance the Food and Drug Administration (FDA). Early
last year we created the NCI/FDA Interagency Oncology Task Force to
leverage the expertise of both agencies for the expressed purpose of
streamlining and accelerating the development of preventive,
diagnostic, and therapeutic interventions for cancer. Considerable
progress has already been made in the areas of joint training and
fellowships, developing markers of clinical benefit, improvement in the
overall process of oncology drug development, and creation of a common
bioinformatics platform (caBIG) to improve the organization and
reporting of data from oncology clinical trials. These partnerships are
critical. Each agency, along with the other sectors involved in the
development, commercialization, and delivery of the new inventions we
desperately need to preempt cancer, is a valued partner who can unite
with us to facilitate and speed the overall process.
Last year, I closed by telling members of this committee that we
stand at a pivotal crossroads--a defining moment in this nation's
effort to prevent and cure cancer. Over the past 12 months we charted
the future course forward--through the creation and implementation of
innovative strategies--and have undertaken initiatives that will allow
us to move rapidly toward a day when cancer will become a chronic
disease. What was once a vision is becoming reality through the
combined efforts of researchers and leaders from all sectors, patients
and their families--and so many others. I believe that together we will
realize the economic and human benefits of eliminating the suffering
and death due to cancer, and in this quest, inform our efforts to
transform our overall health care system.
______
Prepared Statement of Dr. Anthony S. Fauci
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Allergy
and Infectious Diseases (NIAID) of the National Institutes of Health
(NIH). The fiscal year 2005 budget of $4,425,507,000 includes an
increase of $122,467,000 over the fiscal year 2004 enacted level of
$4,303,040,000, comparable for transfers proposed in the President's
request.
NIAID conducts and supports research studies to understand, treat,
and prevent infectious diseases such as HIV/AIDS and other sexually
transmitted infections, influenza, tuberculosis, malaria, and illness
from potential agents of bioterrorism. In addition, the Institute
supports research on transplantation and immune-related illnesses,
including autoimmune disorders, asthma and allergies. For 56 years,
NIAID-sponsored research has led to new therapies, vaccines, diagnostic
tests, and other technologies that have improved the health of millions
of people worldwide. Historically, NIAID has accomplished its mission
with a strong commitment to basic and targeted research in immunology,
microbiology, and infectious disease, disciplines that are related and
complementary. The new initiatives of the NIH Roadmap, and the
information, reagents and infrastructure they will produce, will
further promote the efficient and effective movement of NIAID
discoveries from the laboratory bench to the bedsides of patients.
the niaid research response to the threat of bioterrorism
The use of deadly pathogens such as smallpox or anthrax as agents
of bioterrorism is a serious threat to the citizens of our nation and
the world, and biodefense research to mitigate this threat is a key
focus of NIAID research. Since the anthrax attacks of 2001, NIAID has
significantly strengthened, accelerated, and expanded our biodefense
research program. NIAID-supported biodefense research includes: (a)
basic studies of the structure, ecology, and disease-causing mechanisms
of microbes that could be used by bioterrorists; (b) the response of
the immune system to these pathogens, and; (c) the translation of this
knowledge into safe and effective countermeasures--treatments,
diagnostics, and vaccines. To achieve our biodefense research goals,
NIAID works closely with partners in academia, industry, and other
private and public-sector agencies. Research on potential agents of
bioterror promises to enhance not only our preparedness for
bioterrorism, but also for naturally occurring endemic and emerging
infectious diseases.
Progress in biodefense research has been swift and substantial.
More than 50 major NIAID initiatives involving intramural, academic and
industrial partners have been undertaken. As part of this effort, the
Institute has greatly increased biodefense research capacity. For
example, NIAID recently funded eight Regional Centers of Excellence for
Biodefense and Emerging Infectious Diseases Research. This nationwide
network of multidisciplinary academic centers will conduct wide-ranging
research on infectious diseases and the development of diagnostics,
therapeutics and vaccines. In addition, NIAID is supporting the
construction of two National Biocontainment Laboratories (NBLs) and
nine Regional Biocontainment Laboratories (RBLs). These high-level
biosafety facilities promise to speed the development of effective
therapies, vaccines and diagnostics for diseases caused by agents of
bioterror as well as for naturally occurring emerging diseases such as
SARS and avian influenza.
In addition, NIAID has developed and expanded contracts to screen
new drugs; develop new animal models and establish a reagent and
specimen repository. NIAID also has made a significant investment in
determining the genetic sequences of the genomes of a range of
pathogens, which has helped to illuminate the workings of all classes
of microorganisms. NIAID-supported researchers and their international
colleagues have sequenced genomes representative of all bacteria
considered bioterror threats (including multiple strains of the anthrax
bacterium), as well as at least one strain of every potential viral and
protozoan bioterror pathogen. NIAID also is funding research to better
understand the body's own protective mechanisms. A new NIAID program,
the Cooperative Centers for Translational Research on Human Immunology
and Biodefense, will conduct research to better understand the human
immune response to potential agents of bioterror, with the objective of
developing new bioterror countermeasures. Another large-scale program
is funding sophisticated studies of the human innate system, comprised
of the cells that are the ``first responders'' to infection. Boosting
innate immunity holds great promise for developing fast-acting
countermeasures to mitigate the effects of bioterror pathogens or
toxins.
The ultimate goal of all NIAID biodefense research is the
development of medical countermeasures. NIAID-supported scientists have
identified: (a) antivirals that may play a role in treating smallpox or
the complications of smallpox vaccination; (b) several approaches to
blocking the toxins of the anthrax bacterium; as well as (c)
antibiotics, antivirals and antitoxins against other major bioterror
threats. New and improved vaccines against smallpox, anthrax and other
potential agents also are being developed, with the objective of adding
them to the Strategic National Stockpile (SNS). For example, NIAID has
sponsored the development of a next-generation anthrax vaccine known as
rPA, with the goal of adding 75 million doses to the SNS to protect
U.S. citizens. Clinical trials of rPA are ongoing; results to date
build on similar findings in animal studies and suggest that the
vaccine is safe and capable of evoking a robust immune response.
Researchers also will test whether the currently recommended course of
antibiotic therapy for individuals exposed to anthrax spores can be
reduced by vaccinating exposed subjects with rPA.
NIAID-supported researchers also are testing several new smallpox
vaccines that may prove at least as effective as the current smallpox
vaccine, but with fewer side effects. One of these, modified vaccinia
Ankara (MVA), is based on a strain of the vaccinia virus that
replicates less robustly than the traditional Dryvax vaccinia virus,
and is known to cause fewer side effects than the latter. Human trials
of MVA vaccines are underway at NIH and elsewhere. Encouragingly,
recent studies by NIAID intramural scientists and their colleagues have
shown that MVA protects monkeys and mice from smallpox-like viruses.
NIH also has launched the first human trial of a vaccine designed to
prevent infection with Ebola virus. The trial vaccine, a type called a
DNA vaccine, is similar to other investigational vaccines that hold
promise for controlling such diseases as AIDS, influenza, malaria and
hepatitis.
HIV/AIDS RESEARCH
Most recent estimates on the scope of the HIV/AIDS pandemic are
profoundly sobering. Approximately 40 million people worldwide are
living with HIV/AIDS. In 2003 alone, 5 million people worldwide were
newly infected with HIV--about 14,000 each day, more than 95 percent of
whom live in low and middle income countries. In 2003, 3 million people
worldwide with HIV/AIDS died. In the United States, nearly one million
people are living with HIV/AIDS, and by the end of 2002, more than
500,000 people with HIV/AIDS had died. As shocking as these numbers
are, they do not begin to adequately reflect the physical and emotional
devastation to individuals, families, and communities coping with HIV/
AIDS, nor do they capture the huge deleterious impact of HIV/AIDS on
the economies and security of nations, and indeed entire regions. Even
as the burden of HIV/AIDS continues to grow, recent developments
provide some measure of optimism. For example four new antiretroviral
drugs were licensed in 2003 by the U.S. Food and Drug Administration
(FDA), each of which built on NIAID-sponsored research and/or has been
tested in NIAID clinical trials networks. Many other ``next-
generation'' anti-HIV drugs are in clinical trials.
A vaccine that prevents HIV infection--or at least slows the
progression of disease--is a critical NIAID priority. Vaccine
developers face formidable obstacles, including the genetic diversity
of the virus and the lack of a clear understanding of the immune
responses that might protect against HIV infection. Nonetheless, NIAID
and our academic, industrial, international and philanthropic partners
have made significant progress. Numerous HIV vaccine candidates are in
various stages of preclinical and clinical development. The new
Partnership for AIDS Vaccine Evaluation (PAVE) promises to optimize
these efforts. PAVE is a coordinated HIV vaccine research effort that
includes the three government agencies most involved in this activity--
NIH, the Centers for Disease Control and Prevention (CDC), and the
Department of Defense. These agencies will work together to ensure that
research protocols, standards, and measures are developed in a
coordinated and harmonized manner so that outcomes can be compared
across trials in the most cost effective and scientifically efficient
manner. International non-government organizations (NGOs) and companies
also have expressed interest in joining the partnership. Concurrently,
novel approaches to HIV prevention are being studied and validated,
including topically applied microbicides that individuals could use to
protect themselves from HIV and other sexually transmitted pathogens.
As discussed in the new NIAID Strategic Plan for Topical Microbicides,
more than 50 candidate agents have shown laboratory activity against
HIV and other STDs, and several of these agents have demonstrated
safety and efficacy in animal models. In small human studies, several
products have proven safe; later this year, NIAID's HIV Prevention
Trials Network (HPTN), in conjunction with the National Institute of
Child Health and Human Development, will launch a large international
study to test two promising products in more than 3,000 women at high
risk of acquiring HIV in the United States, five African countries, and
India.
RESEARCH ON OTHER EMERGING AND EMERGING INFECTIOUS DISEASES
Infectious diseases have always afflicted humanity, and they will
continue to confront us as long as man and microbes co-exist.
Unfortunately, the viruses, bacteria, and parasites that cause
infectious diseases do not remain static, but continually and
dramatically change over time as new pathogens (such as HIV and the
SARS coronavirus) emerge and as familiar ones (such as influenza virus
and West Nile virus) re-emerge with new properties or in unfamiliar
settings.
West Nile virus (WNV) first appeared in the western hemisphere in
1999, and by 2003 had spread to 45 states in the United States. NIAID
has moved quickly to address this threat with basic research on the
virus and its maintenance in nature, the development of vaccines and
treatments, and the provision of reagents and other resources to the
research community. NIAID also is supporting the development of three
types of vaccines, as well as the screening and testing of WNV
therapies. For example, the NIAID-sponsored Collaborative Antiviral
Study Group is assessing the safety and efficacy of WNV immunoglobulins
in patients with, or at high risk of serious brain diseases caused by
WNV.
Severe acute respiratory syndrome (SARS) is a new infectious
disease first identified in humans in early 2003. The prompt
recognition that SARS is caused by a new type of coronavirus, and the
rapid progress in SARS research reflect the dedication of and
collaboration by the world's medical researchers and public health
experts, including NIAID-sponsored scientists in the United States and
abroad. NIAID supports research to understand the epidemiology and
biology of the SARS virus and how it spreads, and to develop SARS
countermeasures. Several approaches to SARS countermeasures are being
pursued by the NIAID Laboratory of Infectious Diseases, the NIAID
Vaccine Research Center, and by our contractors and grantees. For
example, NIAID is participating in a project to screen up to 100,000
antiviral drugs and other compounds for activity against the SARS
virus, and will test the most promising in animal models and human
clinical trials. A number of compounds have shown promise in the test
tube, including alpha interferon, a drug already approved by the FDA
for the treatment of hepatitis B and C infections.
NIAID scientists and grantees are pursuing several parallel
approaches in the search for a SARS vaccine. Once these experimental
vaccines are ready, NIAID plans to test them in human clinical trials
in our network of Vaccine and Treatment Evaluation Units. New research
suggests that a SARS vaccine is within reach: NIAID intramural
scientists have demonstrated that the mouse immune system develops
antibodies capable of single-handedly neutralizing the SARS virus. This
discovery affirms that researchers developing vaccines that trigger
antibodies to the SARS virus are heading in the right direction. These
findings also indicate that drug researchers can use laboratory mice as
a model to evaluate whether a drug blocks the SARS virus. Both findings
could help lessen the time it takes to develop an effective vaccine or
antiviral drugs for SARS.
Influenza is a classic example of a re-emerging disease; it is not
a new disease, but it continually changes. Because the replication
machinery of the influenza virus is error prone, as the virus
multiplies it can mutate to a slightly different form; this is referred
to an ``antigenic drift.'' Such viruses might require a slight
modification of the yearly influenza vaccine to accommodate these
changes. In addition, non-human influenza viruses such as avian
influenza, can emerge that may be able to jump species into domestic
poultry, farm animals such as pigs, and humans. This type of
significant change in the antigenic makeup of the virus is referred to
as ``antigenic shift.'' Deadly pandemics associated with antigenic
shifts are known to have occurred in 1918, 1957, and 1968. The pandemic
that occurred in 1918-1919 after an antigenic shift killed 20-40
million people worldwide, including more than half a million in the
United States. This recent history explains the current high level of
concern about the appearance of new forms of virulent H5N1 avian
influenza viruses in Asia that can adapt themselves by mutation to
infect humans as has been the case already in dozens of individuals in
Viet Nam and Thailand. Of even greater concern is the possibility that
this avian virus can combine or reassort its genes with a human
influenza virus and acquire the capability of readily spreading from
person to person resulting in a new pandemic. Given the poor condition
of public health systems in many underdeveloped regions and the speed
of modern air travel, the consequences of such an event, should it
result in an influenza pandemic, would be severe.
To address this threat, NIAID supports a broad program to develop
more effective approaches to controlling influenza virus infections.
Research includes programs to understand the pathogenesis,
transmissibility, evolution, epidemiology, and the immune response to
influenza viruses, as well as to develop new diagnostics, antiviral
drugs and vaccines. NIAID currently supports several research projects
to develop vaccines that could be manufactured more rapidly, are more
broadly cross-protective, and are more effective than current influenza
vaccines. The use of reverse genetics--a tool developed by NIAID
grantees--holds the promise for more rapid generation of vaccine
candidates that match the anticipated strain expected to circulate
during the influenza season. Reverse genetics also can be used to turn
highly pathogenic influenza viruses into vaccine candidates more
suitable for vaccine manufacturing by removing or modifying certain
virulence genes; laboratories around the world are using the technique
to prepare vaccine candidates against the H5N1 viruses emerging in
Asia. NIAID also is funding the development of new influenza vaccine
technologies. Recently, NIAID supported a Phase II clinical trial of a
new influenza vaccine produced in a cell culture system as an
alternative to manufacturing the vaccine in eggs. Because NIAID has had
remarkable success in the past with groundbreaking vaccine research--
including advances that led to hepatitis B, Haemophilus influenzae b,
pneumoccocal pneumonia, and acellular pertussis vaccines--we are
confident that one of the approaches that we are pursuing also will
lead to a useful, ``next-generation'' influenza vaccine that can
readily be adapted to emerging influenza strains.
RESEARCH ON IMMUNE-MEDIATED DISEASES
Immune-mediated diseases such as autoimmune diseases, allergic
diseases, and asthma are important health challenges in the United
States and abroad. Autoimmune diseases afflict 5 to 8 percent of the
U.S. population; asthma and allergic diseases combined represent the
sixth leading cause of chronic illness and disability in the United
States, and the leading cause among children. The past two decades of
fundamental research in immunology have resulted in a wealth of new
information and extraordinary growth in our conceptual understanding of
the immune system and the pathogenesis of immune-mediated diseases,
which has led to the development of many useful therapies. For
instance, we now have powerful treatments that selectively target
several of the immune system molecules that cause inflammation, a
hallmark of many autoimmune diseases. NIAID-sponsored researchers are
now developing novel ways of selectively blocking inappropriate or
destructive immune responses, while leaving protective immune responses
intact, an area of research known as tolerance induction. In the Immune
Tolerance Network, a consortium of basic and clinical scientists,
promising studies are underway using tolerance induction to treat
autoimmune diseases, such as rheumatoid arthritis, type 1 diabetes, and
multiple sclerosis; asthma and allergic diseases; and the rejection of
transplanted organs, tissues, and cells. So-called ``tolerogenic''
therapies would replace current lifelong non-specific immunosuppressive
regimens (and their often debilitating side-effects) with short-term
specific regimens that hold the promise of being curative.
Other important research is being conducted by the recently
expanded Autoimmunity Centers of Excellence. The nine centers that make
up this program conduct basic research and clinical trials on new
immune-based therapies for diseases that collectively afflict between
14 and 22 million Americans. The Institute and our collaborators also
have significantly bolstered the study of primary immunodeficiency
diseases--disorders caused by inherited flaws in the immune system that
increase susceptibility to infections--with funding of the Primary
Immunodeficiency Research Consortium (PIRC), a coalition of the world's
most prominent researchers in the field of primary immunodeficiency
diseases.
Another important NIAID research focus is the development of new
interventions to reduce the burden of asthma, a significant and growing
public health problem in the United States and many nations worldwide.
NIAID has long been at the forefront of discoveries leading to the
characterization of asthma and allergic diseases and is now vigorously
pursing the translation of basic knowledge into more effective
treatment and prevention strategies. To develop interventions to
prevent the onset of asthma, more information is needed on the events
that induce asthma. NIAID's Inner-City Asthma Consortium (ICAC) will
soon launch a large study to define and analyze immunological and
environmental influences upon the development of childhood asthma in a
cohort of urban children followed from birth.
CONCLUSION
With a strong research base, talented investigators in the United
States and abroad, and the availability of powerful new research tools,
NIAID anticipates that our basic and applied research programs will
provide the countermeasures to improve our defenses against those who
would attempt to harm us with bioterrorism, will develop new tools in
the fights against HIV/AIDS and other infectious diseases, and will
improve therapies and management of immune-mediated diseases.
______
Prepared Statement of Dr. Nora D. Volkow
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute on Drug
Abuse. The fiscal year 2005 budget includes $1.019 billion, an increase
of $28.273 million over fiscal year 2004 conference level of $990.787
million comparable for transfers proposed in the President's request.
NIDA: 30 YEARS OF DISCOVERY
As the National Institute on Drug Abuse (NIDA) prepares to
celebrate its 30th anniversary this year, I am honored to have this
opportunity to tell you about some of our remarkable scientific
accomplishments and how these advances are setting the course for a
better future. A tomorrow that will bring us even better prevention
interventions to deter the initial use of drugs by those at risk before
they become one of the more than 180 million people around the world
who currently abuse illegal drugs. A future that will also bring us
better treatment interventions to help those who have already become
addicted, and who may suffer from some of the myriad consequences of
drug abuse including HIV/AIDS and comorbid mental illnesses. Research
supported by NIDA, the world's largest supporter of research on the
health aspects of drug abuse and addiction, may even bring us
innovative and improved ways to deal with other major health epidemics
impacting our society, such as chronic pain and obesity.
ADDICTION AND OBESITY: COMMON NEUROBIOLOGICAL MECHANISMS
Obesity and addiction are serious National health problems that may
have much in common. Both addiction and some forms of obesity represent
problems resulting from excessive behaviors and lack of impulse
control. Knowledge derived from addiction research shows that the brain
circuits involved in compulsive eating and impulse regulation are part
of the same brain systems involved in addiction, with the
neurotransmitter dopamine playing a prominent role. (See Figure 1.) A
better understanding of the role of the dopamine and other systems in
the motivation for and salience of food may lead us to the development
of better medications and behavioral interventions for obesity, as well
as addiction. In addition, medications being developed for obesity may
also help to reduce drug use. Because of the commonalities between
these disorders, we are able to share knowledge of brain and behavior
and combine efforts across institutes to forge new insights and
approaches that may result in improved health for all. NIDA is pleased
to be a key participant in a trans-NIH initiative that is looking at
all aspects of this chronic health problem, from its neurobiological
underpinnings to helping people establish healthy behaviors.
THE INTEGRATION OF BRAIN, BEHAVIOR AND HEALTH
Understanding the connections between brain, behavior, and health
will be critical to improving the health of ALL Americans. Science is
at a point where all the elements of the human brain (genes, proteins,
circuits) and its development can now be mapped out.
We did it with the Human Genome and I am confident we can do it
with the brain. We are already beginning to unravel how various genes,
proteins, brain circuits and pathways interact with each other and the
environment to affect all aspects of human behavior. This overarching
approach is necessary if we are to make progress in improving the
quality of life for individuals who suffer from complex disorders, such
as drug addiction, which can start at a young age and continue across
the lifespan. Now that advances in medical sciences have increased the
lifespan of humans, a major challenge becomes to improve the quality of
life of individuals, which hinges on our ability to understand the
neurobiological underpinnings of human behavior and the impact and
malleability the environment can have on it. This pertains not only to
problems such as addiction, but other health problems such as obesity,
adherence to medical regimens and with establishing and maintaining
healthy life styles.
ADOLESCENCE, THE DEVELOPING BRAIN, AND PREVENTION
Collaborating with other Institutes to map out structural and
functional aspects of the brain and how it changes throughout
development will help us better understand human behavior, and how we
can modify it to improve and extend human life. In particular,
understanding the developing adolescent brain will be useful in drug
abuse prevention efforts. Research indicates that exposure to drugs of
abuse in adolescence, when many changes are occurring in the brain, may
be a period of significantly increased vulnerability to drugs' effects.
Fortunately, advances in science and NIH-funded studies have now
brought us to a point where our researchers can use new animal models,
new brain imaging technology and other neurobehavioral assessment tools
to probe the development of brain and behavior interactions. These new
directions in adolescent research will help to inform us on important
aspects of cognition, decision-making, emotional regulation, and risk
perception during adolescence, and will help us determine how these
play a role in the use and consequences of illicit drugs. Armed with
new knowledge about how adolescents make decisions, NIDA will be poised
to design interventions that can reduce drug experimentation and
addiction. We are making progress in this regard through our National
Prevention Research Initiative and through our science education
activities like ``NIDA Goes Back to School Campaign'' where science-
based materials were disseminated to teachers and students all across
America.
EXCELLENT NEWS: DRUG USE DECLINES
Some of the best news to a NIDA Director came in December 2003 when
we released the latest data on teen drug use trends. NIDA's long-
standing Monitoring the Future Survey showed an approximately 11
percent decline in illicit drug use over the last 2 years by students
in the eighth, tenth, and twelfth grades combined. (See Figure 2.) The
use of MDMA or Ecstasy decreased by almost fifty percent for the three
grades combined in that same time period Also encouraging was the fact
that tobacco use among this population was the lowest in the 28 year
history of the survey.
NEWS FOR CONCERN: PRESCRIPTION DRUG ABUSE CONTINUES
There was also some disturbing news last year about youth drug use,
showing very high rates of abuse of prescription pain killers (e.g.,
Vicodin and OxyContin). Remarkably, 1 in 10 twelfth graders reported
abusing Vicodin last year, making it the second most widely abused
illicit substance after marijuana in this population. Hospitals are
also seeing more patients coming to emergency rooms for prescription
drug abuse. According to data from SAMHSA, between 1994 and 2001 the
number of emergency room mentions for hydrocodone and oxycodone
increased 131 percent and 352 percent respectively. When used as
prescribed, medications like Vicodin can be very effective, but when
used improperly they can have very serious adverse health consequences
including death from overdose. More research is needed to prevent,
educate, and treat prescription drug abuse. Developing new medications
that have no abuse or diversion potential is a high priority for NIDA.
Researchers are making progress in this area. Just last year,
researchers developed a compound to selectively affect a cannabinoid
receptor that is involved in regulating pain. Unlike many other
receptors, this one is not found in the brain. When the compound
(AM1241) was given to animals, they were less sensitive to several
forms of painful stimulation. Not only does this research open up a new
arena for pain medication development, but it also sets the stage for
developing new medications that are less likely to be abused. Also,
NIDA's investment in the development of buprenorphine/naloxone for
treating opioid addiction, for example, provides an alternative
medication for pain that has less diversion potential than that of
other opiate analgesics, and exemplifies how science can help alleviate
our Nation's problems.
RESEARCH ON THE CONSEQUENCES OF MARIJUANA, AND THE DEVELOPMENT OF NEW
MEDICATIONS
Research continues to shed new light on the deleterious
consequences of marijuana, the most abused illegal drug in the United
States. Early exposure to marijuana, for example, has been found to
increase the likelihood of a lifetime of subsequent drug problems. A
recent study, published in the Journal of the American Medical
Association of over 300 fraternal and identical twin pairs, who
differed on whether or not they used marijuana before the age of 17,
found that those who had used marijuana early had elevated rates of
other drug use and drug problems later on, compared to their twin who
did not use marijuana before age 17. This study re-emphasizes the
importance of primary prevention by showing us that early drug
initiation is associated with increased risk of later drug problems,
and it provides more evidence for why preventing marijuana
experimentation during adolescence could have a big impact in
preventing addiction.
We are also finding that a lifetime of heavy cannabis use can
result in an overall dissatisfaction with oneself and with life for
most users. Last year, researchers published data on the impact of
long-term cannabis use on life achievement such as educational
attainment and income. Significantly fewer of the heavy cannabis users
completed college and more had household incomes of less than $30,000
compared to individuals who used marijuana minimally.
It is clear, more research is needed to curtail use of this drug.
Although the number of marijuana treatment admissions has increased
from 92,414 in 1992 to 255,394 in 2001, there are relatively few
treatments that have been shown to be effective specifically for
marijuana addiction. NIDA is encouraging researchers, as well as the
pharmaceutical industry, to become more active in finding new
medications for marijuana and for other drugs of abuse. With the fairly
recent discovery of an endogenous cannabinoid system with specific
receptors and endogenous ligands, the likelihood of finding new targets
for medications development is increased. One form of a cannabinoid
receptor antagonist (CB1-receptor) has already been developed by
several pharmaceutical companies and is undergoing clinical
investigation for the treatment of alcoholism and nicotine addition, as
well as obesity. Moreover, preliminary data in humans has shown that it
can block the effects of marijuana.
ACCELERATING RESEARCH DISCOVERIES BENCH TO BEDSIDE: BEDSIDE TO
COMMUNITY NIH ROADMAP AND OTHER INITIATIVES
For science to be useful in preventing and treating addiction this
knowledge has to reach the communities. This is an area where NIDA
continues to excel. Over the past few years, NIDA has established and
strengthened strong collaborative relationships with a number of
government agencies, including the Substance Abuse and Mental Health
Services Administration (SAMHSA) to build national infrastructures that
can facilitate the flow of research into community practice. NIDA's
National Drug Abuse Treatment Clinical Trials Network (CTN), which now
serves 27 states plus the District of Columbia and Puerto Rico, and the
more newly established National Criminal Justice Drug Abuse Treatment
Study (CJ-DATS) exemplify NIDA's commitment to bringing science out of
the laboratory and to the community. These initiatives parallel and
complement those proposed as part of the NIH Roadmap, including the
promotion of interdisciplincary research and the development of
improved infrastructures for clinical research, which aim to accelerate
the advancement of research discoveries from the bench to the bedside
and to the community.
GETTING THE MEDICAL COMMUNITY MORE INVOLVED IN SCREENING AND ADDRESSING
HIV/AIDS AND OTHER DRUG ABUSE CONSEQUENCES
Because drug abuse begins in youth and most pediatricians and
family physicians typically do not ask questions about drug use, NIDA
has launched a Primary Care Outreach Initiative to educate
pediatricians and other primary care physicians about the importance of
early detection and treatment. The medical community is also being
reminded of the need to recognize substance abuse and addiction as
disorders that will affect the course of other diseases, including
mental illness, cancer, cardiovascular and pulmonary diseases, trauma
and infectious diseases. Injection drug use has directly and indirectly
accounted for more than one-third (36 percent) of AIDS cases in the
United States. Data show that drug abuse treatment can reduce
activities related to drug use that increase the risk of getting or
transmitting HIV. Also the fact that the health and social consequences
of drug abuse, including HIV/AIDS, disproportionately affect racial and
ethnic minority populations; for example almost half of HIV/AIDS cases
occur in African Americans even though they constitute only 11 percent
of the population according to the latest Census data, which highlights
the urgency to conduct research that can benefit all populations. (See
Figure 3.)
Using our established networks (CTN and CJ-DATS), NIDA is
strengthening its commitment to attend to associated health problems
like HIV/AIDS, hepatitis and co-morbidity that often accompany
substance use. The CTN, for example has a number of treatment protocols
underway that address HIV/AIDS and hepatitis. Also, because data
suggest that the prevalence of HIV and other infectious diseases is
high among drug users in the criminal justice system, with HIV
seropositivity rates estimated to be 8-10 times higher than in the
general population, NIDA is encouraging more research to prevent and
treat the spread of HIV/AIDS and other diseases among individuals in
the criminal justice system with substance abuse related problems.
CONCLUSION
Our Nation's investment in drug abuse research is showing
reductions in drug abuse rates and its deleterious consequences at the
individual, family, and community level. A continued commitment to
medical research, and to working with other agencies and sectors, will
lead to new advances, technologies and innovations that will result in
a healthier population.
Prepared Statement of Dr. Jeremy M. Berg
Mr. Chairman and Members of the Committee, good morning. I am
pleased to present the President's budget request for the National
Institute of General Medical Sciences (NIGMS). The fiscal year 2005
budget includes a sum of approximately $1,960 million which reflects an
increase of $55 million over the fiscal year 2004 enacted level of
$1,905 million.
CROSS-CUTTING AND CUTTING-EDGE RESEARCH
Both before joining NIGMS as its new director last November and
since then, I have been tremendously impressed by the Institute's
leadership in supporting basic biomedical research--that is, scientific
studies into the most fundamental biological processes that govern
human health. The kinds of research that we fund are both cross-cutting
and cutting-edge. NIGMS-supported studies have shed light on everything
from the three-dimensional structures of individual proteins--life's
building blocks--to the complex interactions between molecules inside
cells. More importantly, by uncovering the previously hidden workings
of this cellular machinery, not only do we gain a better understanding
of the very basis of human health, but we also gain valuable clues to
fixing this machinery when it goes awry. Those clues are essential in
helping scientists develop better methods to diagnose, treat, and even
prevent a wide range of human diseases.
NIGMS has a successful track record of supporting the nation's
brightest minds in basic biomedical science. Perhaps the highest
recognition of that success can be seen in the number of Nobel Prizes
that NIGMS grantees have won over the past four decades: a remarkable
55 to date. This past year was no exception. Roderick MacKinnon, M.D.,
a biophysicist at the Rockefeller University and a long-time NIGMS
grantee, won the 2003 Nobel Prize in chemistry for discovering the
structure and function of membrane ion channels--the ``gatekeepers''
that control what essential molecules move in and out of cells.
MacKinnon's breakthrough provides direct visualization of the basis for
the electric circuits that are responsible for the functioning of our
brains and the beating of our hearts. The detailed structural
information is revealing how local anesthetics work and why some drugs
have life-threatening cardiac side effects. The work of literally
thousands of other researchers has been redirected in response to his
discoveries.
NIGMS' impressive return on investment in basic biomedical research
is also evidenced by the many other prestigious awards honoring our
grantees. In 2003, Rockefeller researcher C. David Allis, Ph.D., won
the third annual Wiley Prize in the Biomedical Sciences for his work on
chromatin, the complex of DNA with proteins that packages genetic
information inside each cell nucleus. The structure of chromatin is
largely responsible for why one cell is a nerve cell while another cell
is a muscle cell, even though they contain exactly the same DNA
sequence. Allis' studies of the chemical modifications that regulate
chromatin hold promise for learning how to control genes that suppress
and inhibit the growth of tumors in cancer. The previous year, two
other NIGMS grantees--Andrew Z. Fire, Ph.D., of the Stanford University
School of Medicine, and Craig C. Mello, Ph.D., of the University of
Massachusetts Medical School--were among the winners of the second
annual Wiley Prize for their groundbreaking discovery of gene silencing
by a mechanism called RNA interference. The phenomenon of RNA
interference is the subject of upcoming meetings at both the National
Academy of Sciences and NIH because of its potential impact for both
basic research and for entirely novel approaches to preventing and
treating disease.
Even greater advances in biomedical science are possible in the
years to come. Through forward-thinking programs designed to foster
innovative research and train the next generation of pioneering
scientists, NIGMS is playing a leading role in the NIH Roadmap for
Medical Research--the exciting new vision of the future recently
launched by NIH director Elias Zerhouni, M.D. I would like to share
with you some of the key strategies we have developed to help realize
this important vision.
BLAZING A TRAIL FOR THE NIH ROADMAP
Throughout its history, NIGMS has helped push back the frontiers of
medical knowledge primarily by funding the most promising research
grant applications submitted by both new and established scientists.
This so-called investigator-initiated research--supported through the
NIH's R01 grant mechanism continues to be the most important instrument
NIGMS has to promote experimentally based, hypothesis-driven research--
the heart of our nation's scientific mission.
In recent years, NIGMS launched a number of larger, targeted
initiatives to address both significant opportunities and critical gaps
in biomedical research today. In many ways, programs such as NIGMS'
Protein Structure Initiative (PSI), its large-scale collaborative
``glue grants,'' and its new Center for Bioinformatics and
Computational Biology have blazed a trail for the NIH Roadmap. Today,
NIGMS is well positioned to participate with other NIH institutes in
transforming the nation's biomedical research capabilities and
accelerating the translation of scientific discoveries from the bench
to the bedside.
Structural biology is part of the Roadmap's New Pathways to
Discovery theme, and NIGMS is playing a key role in this area. One
major activity is the PSI, an ambitious 10-year project launched in
2000. The aim of the PSI is to solve the three-dimensional structures
of thousands of proteins experimentally and ultimately produce
computer-based tools for modeling the 3-D structure of any protein from
its genetic spelling, or sequence. Knowing the structures of proteins
helps scientists understand how these molecules function in health and
disease and aids in the development of new medicines.
Results from the nine pilot centers set up in the first phase of
the PSI are promising, demonstrating that automated protein production
``factories'' are feasible and are yielding high-resolution data that
is already being used by scientists around the world. This year, NIGMS
plans to ramp up the PSI in its second phase, with the funding of
large-scale centers that will dramatically reduce the time and cost of
solving protein structures, as well as specialized centers that will
tackle challenging problems such as membrane proteins and protein
complexes.
NIGMS is also contributing substantially to Roadmap-related
initiatives through its support of research aimed at unraveling the
complexities of living systems. In 2003, the Institute awarded its
fifth glue grant, bringing together a diverse team of scientists to
assemble a complete picture of lipids--fats and oils--inside cells, and
the role they play in heart disease, arthritis, and other major
illnesses. Other ongoing glue grants awarded since the program started
in 2000 include projects aimed at understanding cellular signaling and
communication, cell movement, and inflammation and the way the body
responds to injury.
Last year, NIGMS also added two new Centers of Excellence in
Complex Biomedical Systems Research. At these centers,
interdisciplinary teams of researchers from both the biological and
physical sciences will focus on the emerging field of ``systems
biology,'' which seeks to find hidden patterns of biological
interactions at all levels, from individual proteins to entire
organisms. The new centers join two others launched the previous year
with NIGMS funding.
COMPUTER-BASED SOLUTIONS TO BIOMEDICAL CHALLENGES
Harnessing the power of computers to solve complex problems in
biology is another major theme in both the NIH Roadmap and NIGMS'
research mission. In 2003, the Institute's recently created Center for
Bioinformatics and Computational Biology welcomed its first director,
Eric Jakobsson, Ph.D., a leading researcher in the field from the
University of Illinois at Urbana-Champaign. Dr. Jakobsson has been
instrumental in launching one of the first Roadmap initiatives, a
program to fund the creation of NIH National Centers for Biomedical
Computing. The centers will bring together computer scientists,
biomedical researchers, and experts from the experimental, clinical,
and behavioral sciences to tackle such challenges as developing
computer simulations that will accurately model the complex inner
workings of the human brain and other vital systems.
One of the most exciting prospects for computational biology is the
promise of turning the vast amounts of data generated by the Human
Genome Project into promising new medical treatments that are tailored
to the individual. As Allen D. Roses, M.D., senior vice-president of
genetics research at GlaxoSmithKline, recently observed, ``The vast
majority of drugs--more than 90 percent--only work in 30 to 50 percent
of the people.'' NIGMS is addressing this critical issue through the
Pharmacogenetics Research Network, a nationwide collaboration of
scientists from academia, government, and industry that the Institute
spearheaded in 2000, with additional funding from five other NIH
institutes. The network has already produced a key computer-based
resource that scientists are now actively using: the Pharmacogenetics
and Pharmacogenomics Knowledge Base (PharmGKB). With this and other
tools at their disposal, scientists will be able to study the effect of
genes on people's responses to a wide variety of medicines including
antidepressants, chemotherapy, drugs for asthma and heart disease, and
many others. The ultimate goal of pharmacogenetics research is to help
tailor medicines to people's unique genetic make-ups, thus making
medicines safer and more effective for everyone.
Computational biology is also at the heart of another NIGMS
initiative: the Models of Infectious Disease Agent Study (MIDAS). An
integral component of the overall NIH biodefense plan, MIDAS is a
network of scientists who will produce user-friendly computational
models for policymakers, public health workers, and other researchers
to assist them in making better-informed decisions about emerging
infectious diseases. The first centers funded through the MIDAS
initiative will launch this year and are expected to contribute
significantly to our ability to prevent, detect, and respond to new
infectious diseases, either natural or human-made.
Other NIH Roadmap-related initiatives include NIGMS' program to
establish high-quality chemical libraries that provide scientists with
powerful tools for discovering potential new drugs, and a portfolio of
grants designed to stimulate the development of new molecular imaging
technologies that can be harnessed to visualize the actions of
individual molecules over time in living cells. The effort to create,
distribute, and apply these tools will be tremendously enhanced by
initiatives that are part of the Roadmap.
TEAM SCIENCE AND INTERDISCIPLINARY TRAINING
The increasingly complex nature of biomedical research today
demands new approaches to carrying out the scientific enterprise. NIGMS
has been at the forefront of addressing this issue, especially in its
support for ``team science''--interdisciplinary research that seeks to
combine the skills and expertise of scientists from diverse fields and
backgrounds. And now as part of another major theme in the NIH
Roadmap--Research Teams of the Future--NIGMS is bringing its own
experience to the table to help build successful synergies in large-
scale research collaborations, and to help prepare the next generation
of biomedical scientists trained in multiple disciplines.
For example, NIGMS has led the way in supporting cross-disciplinary
research and training through its Medical Scientist Training Program--
which leads to the combined M.D.-Ph.D. degree and produces
investigators who can bridge the gap between basic and clinical
research. Other NIGMS programs support training in the cellular,
biochemical, and molecular sciences; systems and integrative biology;
the pharmacological sciences; genetics; molecular biophysics;
biotechnology; the chemistry-biology interface; and bioinformatics and
computational biology.
Many NIGMS research and training programs combine both the
biological sciences--cellular and molecular biology, genetics--and the
quantitative sciences--physics, chemistry, engineering, mathematics.
Indeed, bringing together these two scientific cultures is essential if
we are to continue to make important advances in biomedical research in
the 21st century. That growing realization has spurred a flurry of
activity in recent years. For example, NIGMS joined forces with the
National Science Foundation in 2002 to launch an initiative to
encourage the use of mathematical tools and approaches to study
biology. NIGMS is also partnering with the NIH Office of Science
Education on a program to transform undergraduate biology education by
incorporating examples and perspectives from the quantitative sciences
into biology courses. This program responds to the National Research
Council's Bio2010 report.
NIGMS also has a long-standing commitment to increasing the number
of underrepresented minorities engaged in biomedical research. Through
our Division of Minority Opportunities in Research, NIGMS takes a
leading role at NIH to encourage and prepare minority students to
pursue training for scientific careers and to enhance the science
curricula and faculty research capabilities at institutions with
substantial minority enrollments. Both these programs and the efforts
to train and recruit more scientists from the physical sciences into
biomedical research are essential if we are going to have the
biomedical workforce necessary to solve the challenging problems that
lead to human disease and drive up the costs of providing health care.
BALANCING LARGE- AND SMALL-SCALE SCIENCE
As promising and worthwhile as these major initiatives are, we must
not lose sight of NIGMS' mainstay over the past four decades:
investigator-initiated research. By encouraging the best and brightest
basic scientists to pursue new directions in their fields, NIGMS has
made tremendous contributions to advancing biomedical science. It is
often a single investigator, supported by a single grant, who discovers
something that turns out to be the tip of a very important iceberg. And
we must continue to support these creative minds in order to sow the
seeds for tomorrow's advances.
At the same time, we must recognize the need to invest
strategically in targeted, larger-scale research to meet the critical
needs of ensuring the nation's health and well-being, its technological
competence and competitiveness, and its security. In short, we need to
balance small- and large-scale science in a way that both catalyzes and
capitalizes on innovation. With our experience in managing thousands of
individual research grants every year along with a growing number of
multi-institutional, multidisciplinary research efforts, NIGMS can
strike that balance while leaving open the door to future directions
that are still beyond our powers of prediction.
Thank you, Mr. Chairman. I would be pleased to answer any questions
that you may have.
______
Prepared Statement of Dr. Story C. Landis
Mr. Chairman and Members of the Committee, I am Story Landis,
Director of the National Institute of Neurological Disorders and Stroke
(NINDS). I am pleased to present the President's budget request for
NINDS for fiscal year 2005. The fiscal year 2005 budget includes
$1,546,623,000, an increase of $44.9 million over the fiscal year 2004
enacted level of $1,500,693,000 comparable for transfers proposed in
the President's request.
The mission of the NINDS is to reduce the burden of neurological
disorders by finding ways to prevent or to treat these diseases. When I
began as Director about six months ago, one of my first priorities was
to meet with voluntary groups representing patients and their families.
So far, I have met with more than 40 groups, and this remarkable
experience has educated me about the extraordinary range of diseases
within the NINDS mission, the power of their impact, and the urgency of
finding ways to prevent or treat these disorders. These discussions
also reinforce the importance of increasing public-private
partnerships, which is a goal of our Institute, as well as a major
focus of the NIH Roadmap process.
My own research has focused on fundamental questions about how the
nervous system develops how genes help wire up connections in the
brain, how cells choose to become a particular type, and whether there
is any ``plasticity'' in this process. Issues such as these, long
central to basic neuroscience research, are now at the crux of efforts
to devise treatments for neurological diseases. I am encouraged by the
prevention and treatment strategies emerging from the investment in
basic research drugs to home in on the molecules that cause disease,
stem cells to repair the damaged nervous system, natural neurotrophic
factors to promote survival and growth of brain cells, ``vaccines'' to
prevent stroke, implantable stimulation devices to compensate for brain
circuits unbalanced by disease, therapies to turn off, repair or
replace defective genes, neural prostheses to read control signals
directly from the brain, and behavioral and drug interventions to
encourage the ``plasticity'' of the brain and spinal cord to compensate
for damage. The NINDS must continue to support basic research. We must
also re-energize our efforts to translate opportunities into practical
therapies. Today I will highlight a few of the ways we are working to
bring people and resources together to accomplish that.
STEM CELLS
Neural stem cell biology is one area in which basic science and
clinical promise are so closely intertwined that it is easy to forget
the origins of our understanding of neural stem cells in very basic
research. The generation of new neurons in the adult brain was
discovered when a basic scientist sought to understand how male
canaries learn a new song each spring. This year, NINDS researchers
have contributed to advances in identifying and isolating adult neural
stem cells, in understanding the signals that control embryonic and
adult neural stem cells, and in developing stem cell therapies in
animal models that show promise for Parkinson's disease, demyelinating
diseases, such as Canavan, Krabbe, or Tay-Sachs, and many other
disorders. The NINDS has helped foster research on embryonic and adult
stem cells through several initiatives, including training programs in
the use of approved human embryonic stem cells, grant supplements to
compare these to cells from other sources, and scientific workshops. An
NINDS intramural researcher also leads a new NIH facility that is
characterizing the approved human embryonic stem cell lines. For the
coming year, an initiative targeting collaborative research in stem
cell biology, designed to bring together teams of experts from several
areas of stem cell biology, is a high priority.
GENES AND THE NERVOUS SYSTEM
Genetics is another neuroscience research area that has made
astonishing progress. Overall, researchers have identified more than
200 genes that can cause neurological disorders. Gene findings in the
past year are relevant to diseases such as Parkinson's disease,
Charcot-Marie-Tooth disorder, and cerebral cavernous malformations,
which can predispose people to strokes. Discoveries such as these lead
to improved diagnosis, development of animal models, and the first
clues to what underlies disease processes and how to stop them.
Several NINDS efforts bring people and resources together in
genetics. Some are simple, but important, such as programs to promote
sharing of transgenic mice that are essential models of human diseases.
Others are more ambitious, such as the Gene Expression Nervous System
Atlas (GENSAT) project, which will map the activity of thousands of
genes in the brain and provide genetically engineered mouse strains
that allow scientists to study how these genes contribute to health and
disease. Microarray screening centers make another new technology and
the data arising from it widely available. Microarrays allow scientists
to simultaneously monitor the activity of virtually all genes, with
wide potential applications to basic and clinical neuroscience; for
example, recent studies show micrarrays may predict which patients will
respond to approved drugs for multiple sclerosis. The NINDS Human
Genetics Resource Center, established this year, makes DNA samples,
immortalized cell lines, and accompanying clinical and pedigree data
available to all qualified researchers. The repository currently
contains samples related to stroke, epilepsy, Parkinson's disease, and
motor neuron diseases, including amyotrophic lateral sclerosis (ALS)
and spinal muscular atrophy (SMA).
TRANSLATIONAL RESEARCH
``Translational research'' encompasses the many steps that are
needed to move from basic research insights to a therapy that is ready
for human testing in clinical trials, and the NINDS has a long history
of programs in this arena. For example, over three decades, the Neural
Prosthesis program has supported research on electronic and mechanical
devices that help compensate for abilities lost through disease or
injury, including pioneering research on direct brain control of
prostheses, which has recently become a focus of such forward thinking
agencies as the Defense Advanced Research Projects Agency (DARPA). The
NINDS has responded to increasing opportunities by developing a
comprehensive translational research program that fosters cooperative
efforts, provides peer review criteria tailored to the needs of
translational research, and utilizes milestone driven funding, which is
common in industry. In fiscal year 2003, the Institute funded the first
projects in this program, focused on gene and stem cell therapies for
Parkinson's disease, neuroprotectants for stroke and trauma, treatments
for brain tumor, and drugs for epilepsy, ALS and Huntington's disease.
DRUG DEVELOPMENT FOR NEUROLOGICAL DISORDERS
New and expanding efforts to develop drugs complement the broad
translational program. The NINDS has awarded a contract for a high
throughput screening (HTS) facility, and solicited proposals for the
development of disease-related screening tests. HTS uses robotics to
rapidly test large numbers of chemicals to find lead compounds for drug
development and use as research tools. Ongoing screening efforts focus
on ataxia telangiectasia, ALS, and Parkinson's disease. Several NIH
institutes are working together to develop chemical libraries focused
on the brain, and the NIH Roadmap ``Molecular Libraries'' component
will directly facilitate screening efforts such as these.
Another NINDS drug development effort is a longstanding public-
private partnership. Since 1975, the NINDS Anticonvulsant Screening
Project has worked with more than 140 companies and 230 academic
institutions to test more than 20,000 compounds for anti-convulsant
properties, including several drugs now in clinical use. Guided by the
epilepsy benchmarks planning process, the Institute is expanding this
program with increased focus on preventing the development of epilepsy
and on treatment-resistant epilepsy. The NIH Roadmap ``Structural
Biology'' goals to improve our understanding of membrane proteins, such
as ion channels that are implicated in some types of epilepsy and
neurotransmitter receptors that are often the targets for drugs, will
have an important impact on future efforts to develop drugs for this
and many other neurological disorders.
Some drugs developed for epilepsy have shown promise for other
diseases, such as chronic pain. To take advantage of that kind of
crossover, observed in many areas of medicine, the NINDS worked closely
with academia and voluntary disease organizations to develop a
consortium of 26 laboratories to screen a set of 1,040 known drugs,
mostly approved by the U.S. Food and Drug Administration (FDA) for
other uses, for potential use against neurodegenerative diseases. The
Consortium is sharing data on 29 laboratory screening tests based on
molecules, cells in culture, or simple organisms. Several promising
drugs have moved to further testing in animals, and a few may move soon
to clinical trials.
PROGRAM TO ACCELERATE THERAPEUTIC DEVELOPMENT FOR SMA
Valproic acid is one example of a drug, now used for the treatment
of epilepsy, that in the past year has shown promise in cell culture
for a different disease, spinal muscular atrophy (SMA). SMA is the most
common single gene cause of infant mortality. In recent years,
scientists have discovered the gene defects that cause SMA, developed
animal models that mimic essential aspects of the human disease, and
devised plausible strategies for developing therapies. Because of the
impact of SMA and the state of the science, the NINDS chose this
disease as the focus of an innovative approach, initiated in fiscal
year 2003, to expedite the development of therapies. The performance-
based contract mechanism accelerates all steps from recognition of a
research need, through solicitation and review, to funding of targeted
research subprojects, with guidance by an expert steering committee
that takes a very active role in driving the process. If successful,
this approach might be applied to other diseases.
MUSCULAR DYSTROPHY AND CENTERS PROGRAMS
The muscular dystrophies are another group of inherited disorders
that are a high priority for NIH. Researchers, beginning more than a
decade ago, have identified defects in several genes that can cause the
various kinds of muscular dystrophy. These findings have brought
improved understanding of what causes these diseases, better animal
models to develop therapies, and some practical benefits for example, a
new diagnostic test for Duchenne muscular dystrophy will eliminate the
need for painful muscle biopsy in many children, and help identify
female carriers of the disease before they pass it on to their sons.
Therapies to slow or stop muscular dystrophies have been elusive, but
there have been encouraging results recently in animals using drugs,
stem cells, and gene therapy approaches. To expedite progress against
the muscular dystrophies, the NIH has funded three Senator Paul D.
Wellstone Muscular Dystrophy Cooperative Research Centers, with the
expectation that up to three more will be funded competitively in
fiscal year 2005. The NIH is also working together with the broadly
representative interagency Muscular Dystrophy Coordinating Committee
(MDCC) on developing a muscular dystrophy research and education plan
for NIH.
The NINDS, often working with other components of NIH, has several
centers programs, such as the Morris K. Udall Parkinson's Disease
Centers of Excellence, the Specialized Programs of Translational
Research in Acute Stroke (SPOTRIAS), the Studies to Advance Autism
Research and Treatment (STAART), and the Specialized Neuroscience
Research Program (SNRP), which encourages minority scientists and
addresses health disparities in neurological disorders. Other centers
focus on disorders such as brain tumor, spinal cord injury, and head
trauma.
CLINICAL TRIALS
The NINDS continues to set standards of quality and innovation in
clinical trials that evaluate whether potential treatments or
preventive measures are safe and effective. One recent example, the
Neuroprotection Exploratory Trials in PD (NET-PD), was launched in
April 2003 to evaluate drug therapies that might slow the progression
of Parkinson's disease. The project rigorously selected candidate drugs
from a broad array of potential compounds identified by working with
clinicians and researchers throughout academia and industry. The 42
clinical sites have recruited individuals with early, untreated
Parkinson's, and early phase trials of four drugs will be completed in
early 2005. In the coming year, the NINDS clinical trials program is
also working to train researchers to conduct clinical trials and to
develop a broad clinical trials network that will encompass the greater
community of neurologists. Clinical trials for neurological disorders
is another area in which the cross-cutting NIH Roadmap efforts for
``Re-engineering the Clinical Research Enterprise'' are likely to have
a major impact.
INTRAMURAL PROGRAMS
Before becoming the director of NINDS, I led the Institute's
intramural program on the NIH campus in Bethesda, MD, which is one of
the largest basic and clinical neuroscience programs in the world. In
addition to recruiting superb individual scientists in fields such as
ion channels, genetic diseases of the nervous system, brain tumors, and
stroke, a central focus of the program has been to bring researchers
together from disparate fields of science. To this end, the Porter
Neuroscience Research Center, opening its first phase in 2004, brings
together scientists from eight institutes to ``put the brain back
together'' by overcoming artificial disciplinary boundaries within and
across institutes and by setting the standard for collaborative
research in neuroscience.
FUTURE COOPERATIVE EFFORTS
I have mentioned a few areas in which the NIH Roadmap efforts will
facilitate our efforts against neurological diseases, but the same can
be said of virtually every major effort within the Roadmap. Driven by
the science, several NIH components that have a major focus on the
brain are also increasingly working together to form a ``blueprint for
the brain,'' in which cooperative efforts across Institutes can
expedite progress. These Institutes already cooperate extensively in
areas such as training of researchers, genetics, autism, muscular
dystrophy, health disparities, brain tumors, stroke, and pediatric
neuroimaging, to name a few examples. I hope to report to you in the
future about progress in forming other cooperative ventures aimed at
our common goal of finding better ways to prevent or to treat all
disorders that affect the brain and other parts of the nervous system.
Thank you, and I would be pleased to answer questions.
______
Prepared Statement of Dr. Stephen E. Straus
Mr. Chairman and Members of the Committee: I am pleased to present
the President's fiscal year 2005 budget request for the National Center
for Complementary and Alternative Medicine. The fiscal year 2005 budget
includes $121.1 million, an increase of $4.2 million over the
comparable fiscal year 2004 appropriation of $116.9 million.
INTRODUCTION
Five years ago, recognizing the increasing public health
opportunities of complementary and alternative medicine (CAM) and the
challenges to research in this area, Congress elevated the NIH Office
of Alternative Medicine to the National Center for Complementary and
Alternative Medicine (NCCAM). Several months later, as NCCAM's first
Director, I articulated a set of priorities for the Center that
emphasized growth in the portfolio of rigorous research project grants,
enhanced investments in research training and careers awards to build
an effective CAM research collective, creation of an intramural
research program (IRP), and commitment of stable funding for research
centers. As we embark on planning our second 5 years of work, I am
pleased to report that NCCAM has achieved these and many other critical
objectives.
NCCAM's success to date is evident in some of its vital statistics:
--Under the President's proposed fiscal year 2005 budget, NCCAM's
investment in research project grants will have increased from
approximately $10 million in 1999 to almost $76 million, while
funding for research training and career awards will have
increased from under $1 million in 1999 to approximately $8.8
million.
--In collaboration with other NIH Institutes and Centers (ICs), NCCAM
has launched nine multi-center Phase III clinical trials of
popular CAM interventions for chronic illnesses that affect so
many Americans, including osteoarthritis, dementia, cancer, and
coronary artery disease.
--NCCAM established an intramural research program in 2001, which
studies CAM approaches to diseases of aging, including
arthritis, depression, muscle wasting, cancer, pain, and
diabetes.
--Based on a comprehensive external review, NCCAM refined its
research centers program to support rigorous investigations at
both traditionally research-intensive and CAM institutions. In
2003, NCCAM made its first round of revised center awards in
three categories: Centers of Excellence for Research on
Complementary and Alternative Medicine, Developmental Centers
for Research on Complementary and Alternative Medicine, and
Planning Grants for International Centers for Research on
Complementary and Alternative Medicine. NCCAM's Centers program
will foster capacity in CAM research, catalyze more effective
and essential partnerships between CAM institutions and
research-intensive universities, and facilitate the integration
of effective CAM therapies with conventional medical
approaches.
Already, the nearly 800 projects that NCCAM has supported since
1999 have yelded over 700 scientific publications, including some that
were published in the most prestigious journals--Journal of the
American Medical Association, New England Journal of Medicine, and
Proceedings of the National Academy of Sciences. Complementing these
research and research training activities are extensive efforts to
communicate research results and other critical information about CAM
to the public and practitioners. NCCAM's award-winning Web site is
visited over 1.5 million times each year for its 90 fact sheets,
consumer alerts, news releases, and announcements of new research
initiatives. In a partnership with the National Library of Medicine,
NCCAM helped create a CAM subset on the reference database PubMed that
now hosts nearly 400,000 reports about CAM studies, which are available
to anyone with Internet access. In the aggregate, the investments made
in NCCAM's first 5 years are already informing the health care
decisions Americans make at home and in consultation with their
practitioners.
In its first 5 successful years, NCCAM has become fully integrated
within the NIH, developing a research agenda that is responsive to its
mission, fiscally accountable, and supportive of rigorous CAM research.
NCCAM's research priorities today encompass six thematic areas in which
CAM can have a public health impact: obesity, botanicals, brain-body
interactions, acupuncture, neurodegenerative diseases, and HIV/AIDS.
The next section highlights some of the advances and activities in
three of these priority areas.
ADDRESSING THE OBESITY EPIDEMIC
An alarming 65 percent of American adults,\1\ 16 percent of
adolescents, and 10 percent of American children are now overweight.\2\
Obesity results from complex interactions among human biology,
behavior, and the environment and, therefore, requires a
multidisciplinary approach to prevent and treat it. NCCAM is
contributing to the trans-NIH strategy to address this epidemic by
supporting studies of the safety and efficacy of popular, but
unsubstantiated, dietary approaches to obesity and its many
complications. One of the most popular approaches today is the diet
plan championed by the late Dr. Robert Atkins, which emphasizes a low-
carbohydrate, high-fat, high-protein regimen.
---------------------------------------------------------------------------
\1\ Journal of the American Medical Association, 288 (14): 1723-
1727, Flegal et al, ``Prevalence and trends in obesity among U.S.
adults, 1999-2000''
\2\ Journal of the American Medical Association, 288 (14): 1728-
1732, Ogden et al, ``Prevalence and trends in overweight among U.S.
children and adolescents, 1999-2000''
---------------------------------------------------------------------------
In fiscal year 2003, NCCAM-sponsored researchers reported in the
New England Journal of Medicine on a ground breaking 1-year, multi-
center trial about the effects of the Atkins diet on weight loss and
risk factors for cardiovascular disease. At 6 months, those on the low-
carbohydrate diet had lost more weight and had reduced levels of blood
lipids more than those on the conventional diet. At the end of 1 year,
however, the differences between the two groups of dieters lessened,
leading investigators to call for larger and longer-term studies. NCCAM
is working with its NIH partners to support a larger and more
definitive study.
In its intramural program, NCCAM researchers are testing whether
the dietary supplement glucosamine, used by over 4 percent of older
Americans for degenerative arthritis, causes resistance to insulin, a
condition that predisposes one to diabetes--a disease linked to
obesity. Other IRP studies are evaluating carnitine, a nutrient
essential for the normal metabolism of fats, to see whether it can
reduce abdominal fat content, stimulate weight loss, and improve
glucose utilization.
In fiscal year 2005, as part of the overall trans-NIH focus on
obesity, NCCAM will cosponsor two major initiatives in obesity
research, Neurobehavioral Basis of Obesity and Prevention and Treatment
of Pediatric Obesity in Primary Care Settings. The first seeks to
bridge the gap between understanding the molecular and genetic
regulation of food intake and behavioral influences on obesity. The
pediatric initiative will evaluate preventive and therapeutic
strategies for obesity that could be recommended for children and
adolescents in primary care settings, such as a physician's office,
primary care clinic, or HMO.
EXAMINING THE SAFETY AND EFFECTIVENESS OF BOTANICAL PRODUCTS
Approximately 14 percent of Americans use herbal supplements to
prevent disease, maintain wellness, or treat illness or pain.\3\ Many
of these people also take prescription drugs. NCCAM-supported research
is identifying herbal products that interact with drugs and the
underlying biochemical mechanisms of these interactions. For example,
studies have shown how St. John's wort and PC SPES (a botanical mixture
that had been used to treat advanced prostate cancer) induce the
activity of a key liver enzyme that is responsible for the metabolism
of some 80 percent of all drugs. This finding shows how herbal
supplements have the potential to either enhance a drug's toxicity or
reduce a drug's effectiveness when a patient takes both dietary
supplements and prescription medication.
---------------------------------------------------------------------------
\3\ Journal of the American Medical Association, 287 (3); 337-344;
Kaufman et al., ``Recent patterns of medication use in the ambulatory
adult population of the United States: the Slone survey.''
---------------------------------------------------------------------------
Each year in the United States, an estimated 70,000 people are
diagnosed with head and neck cancers, which are typically resistant to
multi-drug chemotherapy. In fiscal year 2003, NCCAM-sponsored
researchers examined extracts from the root of Scutellaria baicalensis,
a Chinese herb, for activity against head and neck cancers. The new
study is promising because it shows that the herbal extracts strongly
inhibit the growth of human head and neck cancer cells in vitro as well
as in mice with tumors composed of human cells. Future studies will
determine the herb's effects on regulating the cell replication cycle
and whether it can be translated into a safe and effective intervention
for head and neck cancer patients.
While some research studies confirmed the promise of certain
botanicals, others have found herbs that do not deliver on their
claims. One example is guggulipid, a botanical extracted from the resin
of the mukul myrrh tree, that is marketed in the United States as a
dietary supplement to help control blood cholesterol levels and
maintain a ``healthy heart.'' In an 8-week placebo-controlled study
involving over 100 subjects, NCCAM-funded scientists found that neither
the standard or even higher doses of guggulipid significantly lowered
the levels of the key low-density lipoprotein (LDL) form of cholesterol
in people with high blood cholesterol. This study highlights the need
to study popular botanicals that the public is using so that
individuals can make informed decisions regarding their own care.
In fiscal year 2005, NCCAM will co-sponsor three important
initiatives on the use of botanicals as dietary supplements. Through a
newly refined Botanical Research Centers Program being mounted with the
NIH Office of Dietary Supplements and the National Institute of
Environmental Health Sciences, NCCAM will support interdisciplinary
studies of botanicals to generate evidence regarding their safety and
potential public health benefits. NCCAM also plans to establish a Phase
I Resource Center (PRC) to define the pharmacology and optimal dosing
of botanical products and functional foods. Finally, in fiscal year
2005, NCCAM plans to initiate in vitro, animal, and preliminary
clinical studies of Silybum marianum (milk thistle) and its derivative
silymarin as a treatment for chronic hepatitis and cirrhosis of the
liver, conditions that affect millions of Americans for whom, to date,
there is no effective treatment.
Through these programs, NCCAM thoughtfully is investing in programs
of basic research to discover natural products and food supplements
that could open new avenues for prevention and treatment of conditions
that affect the health, well being, productivity, and quality of life
of millions of Americans.
INVESTIGATING BRAIN-BODY INTERACTIONS
NCCAM scientists are exploring ancient practices such as
meditation, Tai Chi, hypnosis, and yoga to understand their abilities
to harness the healing effects of the mind on the body. For example,
NCCAM grantees are conducting pilot studies of yoga as a behavioral
intervention for the management of chronic obstructive lung disease,
insomnia, and chronic low back pain, as well as investigating whether
one's spirituality and religiosity have a significant influence on
immune system functioning.
In 2003, NCCAM-funded researchers reported that a traditional
Chinese meditative exercise regimen, Tai Chi, could enhance physical
performance and immune responses in older people. As people age,
immunity to the virus that causes chicken pox wanes until the infection
can reactivate from its dormant state in nerves and develop into the
painful condition shingles. The study concluded that older adults who
participated in a form of Tai Chi for 15 weeks experienced
statistically significant increases both in ellular immune responses to
the virus and in physical performance. This is the first scientific
study to show that a CAM approach is responsible both for improvements
in physical function and in virus-specific immunity and provides the
basis for a larger study of Tai Chi currently being supported by NIH.
To further stimulate research in the field of brain-body
interactions, NCCAM is a cosponsor of several NIH research initiatives.
The first effort, entitled Mind-Body Interactions and Health:
Exploratory/Developmental Research Program, will foster program
development at institutions that have high potential for advancing
mind-body and health research. The second initiative, Research on Mind-
Body Interactions and Health, will support interdisciplinary
collaborations and innovations to understanding the underlying
processes of mind-body interactions and health and translating basic
knowledge into interventions and clinical practices.
LOOKING FORWARD
Five years ago, the discipline of rigorous CAM research was in its
infancy. Absent precedents for the field, NCCAM's initial efforts led
to supporting an array of studies spanning numerous CAM practices and
health conditions. In these first years, NCCAM found that to better
ensure that its funds yield compelling results, it needed to encourage
studies on mechanisms of action of CAM approaches, well-developed Phase
I and II clinical trials as a foundation for future definitive studies,
and collaborations between CAM and research-intensive institutions. In
the coming years, the Center will refine its research priorities even
more, to emphasize those areas and conditions for which CAM can have
the greatest health impact. To this end, in 2004, NCCAM began a formal
process to seek input from its many stakeholders, including the
scientific community, health professionals, and the public to further
target its research, training, and communication goals and to craft a
long-term plan to guide the way toward its tenth anniversary.
Complementing this strategic planning process are the trans-NIH
Roadmap for Medical Research activities in which NCCAM leadership has a
significant role. Core themes of the Roadmap resonate strongly with
NCCAM because they promise to provide NCCAM grantees access to more
sensitive technologies, richer environments for learning and conducting
interdisciplinary research, and a re-engineered platform for clinical
trials, all in ways that small institutes and centers could never
achieve on their own.
In the coming months and years, I look forward to sharing with
members of the Committee, the scientific community, practitioners, and
the public our second strategic plan and the results of the research
and training investments that we have made. Thank you for your interest
in NCCAM's progress and plans. I would be pleased to answer any of your
questions.
______
Prepared Statement of Dr. Kenneth Olden
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget for the National Institute of Environmental
Health Sciences (NIEHS). The fiscal year 2005 budget is $650,027,000,
an increase of $18,964,000 over the comparable fiscal year 2004
appropriation.
INTRODUCTION
Most complex diseases arise from the interplay between biology,
environment and behavior. It is the NIEHS' mission to understand this
interplay as it translates into increased disease risk. Thanks to the
rare confluence of technology breakthroughs in analysis of genes and
proteins and their recent application to the environmental health
sciences, gene-environment interactions can now be investigated with
more rigor and specificity. Our new opportunities within the framework
of the NIH Roadmap also offer promise for a more rapid understanding
and translation of this knowledge into improved public health. I will
outline several of the NIEHS' most important efforts.
GENES AND ENVIRONMENT
There are two principal avenues for exploration of the complex
interplay between genes and environment. One is to look at the
variations of genes themselves, and the other is to examine how genes
respond to environmental stressors. In the case of the first approach,
NIEHS is conducting the Environmental Genome Project (EGP) an effort to
resequence 544 ``environmentally responsive'' genes--genes which are
thought to be involved in an individual's susceptibility to
environmental exposures--and to identify alleles or genetic variants
associated with these genes. The key objective of the EGP is to
discover and characterize these alleles or genetic variants, called
polymorphisms, and to define their roles in the pathways by which
environmental agents exert their effects on human health and disease.
Last April, the EGP completed the first phase, publishing a catalog
of variation in over 200 genes responsible for detoxifying
environmental compounds such as pesticides, as well as metabolizing
natural biological components such as hormones. Over 17,000 single
nucleotide polymorphisms (SNPs) were identified, with more than 1,000
in coding sequences. This information is already being used to make
significant scientific discoveries. For example, it was found that
people suffering from benzene-induced leukemia lack a certain SNP in
the gene responsible for utilizing a vitamin B, folate, that healthy
people have. Thus, the ability to metabolize folate might relate to the
relative risk of developing leukemia among benzene workers.
To aid in the functional characterization of SNPs in both coding
and regulatory sequences of specific genes, NIEHS initiated the Mouse
Genetic Variation Mapping Initiative. The mouse is the most widely used
mammalian model system for the study of human health and disease for
several reasons, including the fact that the genomes of mice and other
mammals are highly conserved. Most human genes have counterparts in the
mouse genome; thus, cloning of a gene in one species often leads to
cloning of the corresponding gene in the other. The mouse also offers
well developed toxicological and pathology databases and molecular
genetic techniques for construction of gene knockout strains. Data
generated using rodent models have been used widely in preparation of
environmental regulatory policy and by the pharmaceutical industry.
One of the greatest challenges for comparative toxicogenomics is
the integration of the vast amount of genomic information being
generated for a variety of model organisms. At present, there are
several disparate but complementary databases on genomic sequences.
Most of these databases provide data on gene and genome sequences for
individual animal species. These databases do not provide a means to
link the genome data to specific environmental chemicals or to
toxicological and biological endpoints. They also do not enable
researchers to compare information about potentially similar genes and
biological responses across multiple species.
Integrating the large number of disparate data sets is the goal of
the Comparative Toxicogenomics Database (CTD). The CTD was developed
through a collaboration of five NIEHS-funded Marine and Freshwater
Biomedical Sciences Centers. The goal of the CTD is to develop a
comparative database that links sequence information for genes that are
relevant to toxicology to information about gene expression, toxicology
and biological processes. The primary focus of the CTD is on marine and
aquatic organisms as model systems for human diseases. The initial
focus is also on genes that have been identified through the NIEHS' EGP
as important for toxicology in these model systems. However, the
database will eventually merge all gene sequence information generated
on all vertebrates and invertebrates, including aquatic organisms,
worms, flies, rodents, and people. The CTD provides information about
gene curation and annotation (gene synonyms, sets and functions) and
links between gene sequence and toxicity data published in the
scientific literature. These aspects of the database represent an
important advancement for comparative toxicogenomics. Understanding
these mechanisms will allow more informed assessment of human risk by
extrapolating toxicity data from animal models to people and will
provide a mechanism by which members of the research community can
share their data and promote fruitful avenues for future toxicological
research.
At present, the CTD is the only fully curated, publicly available
database of its kind in the world. However, it serves as a prototype
database and data resource for more comprehensive efforts ongoing at
the NIEHS. The centerpiece for these discoveries is the NIEHS' National
Center for Toxicogenomics (NCT), which uses a multidisciplinary
approach to identify genes and proteins affected by specific
environmental exposures. When a person is exposed to a chemical,
physical, or biological agent, cells in the body may respond by
switching on some genes and switching off others, potentially changing
the proteins that are produced by the cells. The on/off pattern of
various genes is different for each specific exposure, creating a
characteristic pattern or ``signature,'' which scientists hope will be
useful in classifying chemicals by their effects on various cellular
processes. By constructing and populating a database of chemical
effects on biological systems, the NCT is assisting the field of
environmental health research to evolve into an information science in
which gene and protein expression datasets are compiled and made
readily available to the scientific community. By building on the data
infrastructure being developed through the CTD and other databases,
NIEHS scientists are developing the sequence-driven and context-
documents Chemical Effects in Biological Systems (CEBS) knowledge base.
CEBS is planned as a public toxicogenomics knowledge base that combines
and integrates scientific data from a multitude of public domain data
sources. These data sources include studies of genetic polymorphisms,
gene expression and proteomics, metabolism and toxicology. Once
sufficient high quality data have been accumulated and assimilated, it
will become possible to characterize an unknown environmental exposure
by comparing its gene and/or protein expression profile to compendia of
expression profiles in the database. Ultimately, the NCT will develop
the capacity to use gene expression signatures and other data to
facilitate characterization of toxicants and their biological effects.
Through the predictive capabilities expected from toxicogenomics,
adverse toxicity in clinical trials will be reduced and the efficiency
of bringing new therapeutics to the public will be increased; adverse
effects from long-term use or from combinations of therapeutic agents
will be better understood and reduced. The final payoff for investing
in CTD and CEBS will be more rational environmental health policy and
an improved understanding of gene-environment contributions to the
major causes of human death and disease.
OBESITY AND ENVIRONMENT
Environment and behavior intersect in fundamental ways,
intersecting with our biology but also with each other. In no area of
public health is this more apparent than with the problem of obesity.
There is a growing body of literature that illustrates the negative
physical and mental health effects of unregulated and poor urban,
rural, and suburban development and planning. These studies have
documented increased rates of obesity, diabetes, depression, anxiety,
and heart disease in these poorly developed areas. For example, in
sprawling communities, higher dependence on motor vehicles has resulted
in polluting the atmosphere with ground-level ozone and particulate
matter, contributing to human health problems such as lung and
cardiovascular disease. People most affected by air pollution include
older adults with pre-existing diseases; children, especially those
with asthma; persons with inadequate health care; and even healthy
individuals who work and exercise outdoors. Lack of safe sidewalks in
growing urban areas has resulted in a reduction in the number of
children walking or biking to schools. Today, only 10 percent of
children walk or bicycle to school--a 40 percent reduction over the
last 20 years (according to researchers in Urban Land). Research
suggests that inadequate urban planning, such as a lack of bike paths
and sidewalks, results in a more sedentary lifestyle of children,
which, in turn, may be a factor in the growing rates of childhood
obesity. All of these examples demonstrate how the physical or built
environment influences choices that ultimately affect health.
The NIEHS is designing a program as part of the trans-NIH obesity
initiative which is designed to examine how the built environment
affects obesity and the effectiveness of changes in community planning,
design, and development in reducing the extent of obesity and
associated comorbidities. These intervention research projects will
develop tools to characterize and measure individual and population-
level indicators of healthful communities--and of residents' lifestyles
and behaviors--that prevent or reduce obesity. We hope that not only
will studies of interaction between parameters of the built environment
and individual lifestyle choices and behaviors help delineate factors
that can prevent or reduce obesity, but also that this work will point
the way towards new, cost-effective intervention strategies that
promote healthful environments and behaviors.
In a related initiative, NIEHS is partnering with the Robert Wood
Johnson Foundation to support a program called Active Living by Design,
which will provide support to 25 communities across the country to
implement active living programs, policies, and communication
strategies to improve community development and promote more healthy
lifestyles. The NIEHS is providing an evaluation component to the
program to determine the efficacy of various policies and promotions in
reducing obesity.
It is critical to delineate the role and impact of community
design, planning, and development on individual and population health
by understanding the contribution of urban/rural planning (i.e., land
use decisions), housing structure, transportation issues, and the
availability of public and green spaces as determinants of mental
health, physical activity, nutrition, and access to healthy foods. In
turn, modifying such parameters may reduce the prevalence of obesity in
adults and children. This research effort will require integrated,
interdisciplinary research teams, including biomedical scientists,
behavioral scientists, social scientists, clinicians, epidemiologists,
urban planners, developers, and architects, as well as active
participation of community members. It is expected that such research
will result in a greater understanding of the health benefits of living
in communities that promote healthful environments and behaviors and
may also impact policy for land use and public health.
TOXICOLOGICAL EVALUATION OF NANOSCALE MATERIALS
Nanoscale materials are a broadly defined set of substances where
at least one critical dimension is less than 100 nm. Ultrafine
particulate matter, e.g. the very smallest particles of soot from such
sources as diesel exhaust, is a well-known example of ambient
nanoparticles; however, this initiative will initially focus on
manufactured nanomaterials of current or projected commercial
importance. Nanoscale materials can in theory be engineered from nearly
any chemical substance; semiconductor nanocrystals, organic dendrimers,
and carbon fullerenes and carbon nanotubes are a few of the many
examples. Nanoscale materials are already appearing in commerce as
industrial and consumer products and as novel drug delivery
formulations. Commercial applications and resultant opportunities for
human exposure may differ substantially for nanoscale vs. ``bulk''
materials.
Currently there is very little research focus on the toxicology of
manufactured nanomaterials. Studies from the ultrafine particle
inhalation toxicology literature hint at the complexity of the topic
and suggest that nanoparticle size can impact toxicity equally if not
more so than chemical composition. There are indications in the
literature that manufactured nanomaterials may distribute in the body
in unpredictable ways and that certain nanoparticles have been observed
to preferentially accumulate in particular organelles. Surface
properties can be changed by coating nanoparticles with different
materials, but surface chemistry also is influenced by the size of the
particle. This interaction of surface area and particle composition in
eliciting biological responses adds an extra dimension of complexity in
evaluating potential adverse events that may result from exposure to
these materials.
The National Toxicology Program (NTP) is developing a broad-based
research program to address potential human health hazards associated
with the manufacture and use of nanoscale materials. The intent of the
NTP/NIEHS research program is to evaluate the toxicological properties
of major nanomaterials classes which represent a cross-section of
composition, size, surface coatings, and physico-chemical properties,
and use these as model systems to investigate fundamental questions
concerning if and how nanomaterials can interact with biological
systems. Some of these fundamental questions include: What are the
appropriate methods for detection and quantification of nanoscale
particles in tissues? How are nanoparticles absorbed, distributed in
the body and taken up by cells? Are there novel toxicological
interactions?
Discussion and review of efforts in this area has highlighted the
need for studies of nanoscale materials that not only apply existing
toxicology testing methodologies, but also explore the development of
appropriate novel toxicological methods to adequately assess potential
human health effects. The NIEHS is looking ahead to be able to
supplement our critically inadequate knowledge of this rapidly emerging
technology.
______
Prepared Statement of Dr. Thomas R. Insel
Mr. Chairman, and members of the Committee, I am pleased to present
the President's budget request for the National Institute of Mental
Health (NIMH) for fiscal year 2005, a sum of $1,421 million, which
reflects an increase of $39 million over the comparable fiscal year
2004 appropriation.
In my statement, I will call to your attention the immense burden
on our Nation of mental and behavioral disorders. In addition, in the
context of a brief review of our research activities and
accomplishments, I will describe some of our efforts, in collaboration
with trans-NIH initiatives, to bring new treatments from the laboratory
to the clinical research arena and ultimately to widespread practice in
the community.
BURDEN OF MENTAL ILLNESS
The National Institute of Mental Health faces an enormous
challenge: to reduce the burden of mental and behavioral disorders
through research on mind, brain, and behavior. Mental disorders are
real illnesses that can be diagnosed and in many cases, treated
effectively. The need is vast: 450 million people worldwide suffer from
a mental disorder. Mental illnesses account for four of the top six
causes of disability among 15-44 year olds in the Western world. By
2020, psychiatric and neurological conditions will have likely
increased their share of the total global burden by almost half, from
10.5 percent to 15 percent.
In addition to morbidity, mental illnesses are a substantial source
of mortality. Of the 30,000 Americans who die by suicide each year, 90
percent have a mental illness. Deaths from suicide outnumber deaths
from homicide (18,000) as well as deaths from AIDS and most forms of
cancer. Suicide is high among several ethnic minority groups, though
remains highest in older white males. Between 1952 and 1992, the
incidence of suicide among adolescents and young adults nearly tripled;
currently it is the third leading cause of death in adolescents.
In addition to the emotional costs, the economic costs of mental
illness are staggering. According to the recent report from the
President's New Freedom Commission on Mental Health, the cost in the
United States from both direct (treatment-related) and indirect
(productivity loss) expenses may exceed $150 billion per year with
rapid annual increases, especially in the drug treatment area. Adding
to that, more than three million people are receiving disability
benefits due to mental disorders. They constitute nearly 28 percent of
disabled workers in the Social Security Disability Insurance Program,
and more than 35 percent of people with disabilities receiving
Supplemental Security Income. Together they accounted for an estimated
$25 billion dollars in cash benefits in 2001.
SCIENCE TO SERVICE
For many mental disorders, there is some form of treatment, but
there is no cure. The report from the President's New Freedom
Commission on Mental Health describes the need for transforming the
delivery of evidence-based treatment and services to communities where
they can directly benefit people with mental illness. To achieve this
goal, NIMH recognizes the need for the research enterprise to partner
with other organizations such as the Substance Abuse and Mental Health
Services Administration (SAMHSA), state governments, and advocacy
groups. In one such example, NIMH and SAMHSA recently funded nine one-
year grants to state mental health agencies to support planning
activities toward the implementation of evidence-based practices.
Proposed science to service research activities include devising
evidence-based group-focused activities for specific ages (child,
adult); managing medication for those with schizophrenia; and providing
cognitive behavioral therapy for people with depression. Each grant is
expected to result in future research and service development
initiatives. Translating scientific breakthroughs into far-ranging
clinical care, we believe, is an urgent and achievable task.
PROGRESS IN GENETICS
In addition to applying what we already know, we must continue the
scientific efforts required to develop better treatments to bring us
closer to our ultimate goals of curing or preventing severe mental
health disorders. To attain these ambitious goals, we will need a much
larger variety of medications and behavioral therapies than are
currently available--treatments that can be tailored to work for all
those who need them, not just a small subset. As an initial first step,
we must discover how genes and the environment interact to produce the
biological variations that can signal vulnerability to disease. This
year has been remarkable in its wealth of discoveries of genes as well
as gene-environment interactions. In depression, for example, NIH-
sponsored researchers found that a variation in the gene that regulates
serotonin transmission can make a person more vulnerable to depression
when faced with stressful life experiences. Those without the gene
variation had no such vulnerability, and appeared to be resilient even
in the face of many life stresses. Those with the gene variation were
not depressed until and unless they faced major life stressors. This
suggests that some of the environmental contributors to illness may
only be detected by first identifying variations in genetic risk.
Future research could help us apply this information to identify those
most at risk, and develop treatments that either target genes or the
environment, or both. It also suggests a new model with which to test
genetic vulnerability and environmental stresses in other major
diseases, such as schizophrenia, anxiety disorders, or eating
disorders.
This year we have also seen exceptional progress in research on
schizophrenia. Several genes have been found which appear to
significantly contribute to the development of schizophrenia, providing
at least a partial blueprint for the genetic risk architecture of the
disease. While we still need to learn more about how they work, this
group of genes should bring us closer to diagnostic tests for early
detection, new targets for treatment, and even new strategies for
prevention. In other studies, genes have been found which are thought
to play a role in obsessive-compulsive disorder, panic disorder, and
autism. NIMH researchers have also identified genes involved in memory
and information processing, both of which are impaired in schizophrenia
and various other disorders. These studies were among those named
collectively as the number two scientific ``breakthrough of the year''
by the prestigious journal Science in December. Most of the studies
listed were conducted by intramural or NIMH-funded investigators.
Studies this year have also provided new insight into the neural
circuitry of anxiety and fear processing, suggesting new targets for
drug development to treat anxiety, post-traumatic stress disorder, and
various phobia disorders.
SCHIZOPHRENIA TREATMENT INITIATIVE
While the news on schizophrenia has been exciting, we recognize
that the road from gene discovery to prevention and treatment is
neither simple nor rapid. To accelerate this process, we created a new
initiative on schizophrenia research. A primary component is a new
intramural interdisciplinary team, ranging from molecular to clinical
scientists, who will lead a broad effort to understand how different
gene variations alter neural networks and disrupt brain activity,
leading to cognitive impairment and psychosis. The team will work to
identify the role of these vulnerability genes, including their
individual contributions to risk, severity of the disease, and drug
response.
A second component of the initiative is a program that targets
cognitive problems for people with schizophrenia. Cognitive deficits,
such as trouble with memory, attention, and executive function
(capacity to make judgments and control impulses) are major
determinants and predictors of long-term disability in schizophrenia.
They remain a significant barrier to a productive life for people with
the disease, yet the medications currently available provide no relief
for cognitive problems. There has been a lack of scientific consensus
on which cognitive impairments should be targeted and which tools are
best for measuring them. As a result, the FDA has not been able to
recognize cognition in schizophrenia as a valid treatment endpoint for
drug registration. To address these issues, NIMH launched the
Measurement and Treatment Research to Improve Cognition in
Schizophrenia (MATRICS) program. It brings together representatives
from academia, industry, and regulatory agencies to develop a
comprehensive assessment tool to measure cognitive functioning in
people with schizophrenia. The second phase is to develop and test
novel compounds designed to enhance cognition.
ROADMAP
For most of our recent genetic discoveries, we lack the molecular
tools needed to link the genes to new treatments. The search for new
molecular tools for schizophrenia and other mental disorders will be
aided greatly by one of the NIH Roadmap initiatives that will establish
a repository of diverse organic chemicals. Organic chemicals, commonly
referred to as ``small molecules,'' have proven to be extremely
important to researchers exploring the functions of the cell at the
molecular level. In fact, most medicines, from aspirin to
antihistamines, are small molecule compounds. This new ``molecular
library'' will offer researchers access to hundreds of thousands of
small organic molecules that can be used as chemical probes to study
cellular pathways. These compounds will help validate new targets for
drug therapy more rapidly, and will enable other researchers to move
them into the drug-development pipeline.
AUTISM
NIMH plays a major role in a broad-based NIH effort to create a
network of autism research centers focusing on the biomedical and
behavioral aspects of the disease. Five institutes at NIH are
coordinating their research efforts in an initiative called the Studies
to Advance Autism Research and Treatment (STAART) Centers program. This
year, the institutes awarded grants to support six new autism research
centers, in addition to the two that were funded last year. NIH expects
to spend $65 million over five years for the eight centers.
NIMH is the lead agency for the Interagency Autism Coordinating
Committee (IACC), a group charged with coordinating research and other
efforts on autism within the Department of Health and Human Services
(HHS). NIMH took the lead in organizing the ``Autism Summit Conference:
Developing a National Agenda,'' a joint effort of the HHS and the
Department of Education, held in November 2003. About 650 people
attended the meeting to address three major areas of emphasis:
biomedical research, implementing early screening and diagnosis, and
improving the accessibility and coordination of services. A key focus
of the meeting was the introduction of a 10-year national research
agenda, developed by an IACC-appointed expert panel. The research
agenda identified roadblocks hindering progress in understanding
autism's causes and developing treatment, and provided goals and
strategies for the next 10 years to overcome these challenges. These
research efforts will be carried out through the centers of excellence
within the STAART network.
PRACTICAL CLINICAL TRIALS
To improve human health, scientific discoveries must be translated
into practical applications. Such discoveries typically begin at ``the
bench'' with basic research where scientists study the mechanisms and
pathogenesis of a disease at a molecular or cellular level--then
progress to the clinical level, or the patient's ``bedside.'' Equally
important is the translation from bedside to practice. Moving new drugs
and therapies more quickly and smoothly out of the research environment
and into the hands of clinicians is a key feature of the NIH Roadmap.
To achieve this, NIH will promote the creation of better integrated
networks of academic centers that work jointly on clinical trials and
which include community-based physicians who care for large groups of
patients. Implementing this vision will require new ways of organizing
the methods in which clinical research information is recorded,
defining new standards for clinical research protocols, and creating
new models of cooperation between NIH and patient advocacy alliances.
For its part, NIMH is finishing up four large-scale, longitudinal
research studies to compare therapeutic approaches for serious mental
illnesses, including schizophrenia, Alzheimer's disease, major
depression, and bipolar disorder. These are different than most
clinical trials, which are usually of short duration and limited to
assessment of clinical symptoms. The NIMH studies are testing the
various treatment options currently available for these disorders in
diverse community populations, recruiting people from a variety of
``real world'' practice settings, and expanding outcome measures to
include functional status and economic costs. The clinical populations
currently enrolled in these NIMH treatment trials are among the largest
and best characterized populations with bipolar disorder,
schizophrenia, and depression ever studied through clinical trials in
mental health. These trials will answer urgent questions about the
treatment of adolescents with depression, the use of atypical anti-
psychotics in people with schizophrenia and Alzheimer's, and the
optimal long-term medication for bipolar patients. When the studies are
over within the next two years, we hope to be able to continue
utilizing this valuable clinical infrastructure--made up of staff,
investigators, federal and state agencies, industry, patients, and
patient advocacy groups--to answer other critical public health
questions in diverse populations.
PRIORITY-SETTING
Over the past five years, we have witnessed unparalleled advances
in the basic sciences relevant to mental health. Genomics, imaging, and
many areas of neurobiology are beginning to reveal a new understanding
of normal and abnormal behavior. Against this backdrop of scientific
progress, we continue to face extraordinary challenges for our patients
with mental disorders. Science now yields opportunities that promise to
deliver for each of these challenges. To realize this promise, we must
define areas of high priority. To assist us, workgroups of our National
Advisory Mental Health Council are reviewing the NIMH portfolio
initially in two key research areas: clinical trials and basic science.
Both workgroups plan to deliver reports by May 2004 and both will
define priority areas using the criteria of relevance, traction, and
innovation. Both workgroups have done an impressive job in reviewing
the hundreds of relevant grants in the portfolio. We look forward to
their recommendations, as well as to those of our Outreach Partners in
every state, the mental health advocacy community, and the public. We
rely on these groups to help us meet our ultimate goal of relieving the
profound misery suffered daily by patients and families affected by
mental disorders.
______
Prepared Statement of Dr. Raynard Kington
Mr. Chairman, members of the Committee: I am pleased to present the
President's budget request for the Office of the Director (OD) for
fiscal year 2005, a sum of $359,645,000, which reflects an increase of
$32,556,000 over the comparable fiscal year 2004 appropriation. The OD
provides leadership, coordination, and guidance in the formulation of
policy and procedures related to biomedical research and research
training programs. The OD also is responsible for a number of special
programs and for management of centralized support services to the
operations of the entire NIH.
The OD guides and supports research by setting priorities;
allocating funding among these priorities; developing policies based on
scientific opportunities and ethical and legal considerations;
maintaining peer review processes; providing oversight of grant and
contract award functions and of intramural research; communicating
health information to the public; facilitating the transfer of
technology to the private sector; and providing fundamental management
and administrative services such as budget and financial accounting,
and personnel, property, and procurement management, administration of
equal employment practices, and plant management services, including
environmental and public safety regulations of facilities. The
principal OD offices providing these activities include the Office of
Extramural Research (OER), the Office of Intramural Research (OIR), and
the Offices of: Science Policy; Communications and Public Liaison;
Legislative Policy and Analysis; Equal Opportunity; Budget; and
Management. This request contains funds to support the functions of
these offices.
In addition, the OD also maintains several trans-NIH offices and
programs to foster and encourage research on specific, important health
needs; I will now discuss the budget request for the OD in greater
detail.
NIH ROADMAP
As part of the NIH Roadmap for Medical Research, the NIH has
launched initiatives in fiscal year 2004 critical to addressing the
roadblocks to the acceleration of science conduct and transfer to the
public. These initiatives promise to yield far-reaching dividends in
medical knowledge and improved health for the public. Under the theme
of New Pathways to Discovery, initiatives are aimed at quantifying and
cataloging complex biological systems and in developing a better ``tool
box'' for today's researchers, for research teams of the future, and
for re-engineering the clinical research enterprise. Examples of
initiatives include the creation of an accessible public library
database for chemically diverse small molecules, centers that will
create new tools to describe the dynamics of protein interactions,
development of novel technologies to study cellular metabolites,
creation of national software engineering system that can facilitate
the ability of scientists to tap into supercomputing networks and share
and analyze complex data, and the early conceptual development of
nanomedicine. The NIH Roadmap initiatives also have taken steps to
prepare Research Teams of the Future, the second theme, by encouraging
scientists and research institutions, including the NIH, to test
alternative models for conducting research that take advantage of the
scientific advances and complexities. A major focus has been placed on
planning and research workforce training for the conduct of
interdisciplinary research, that research that spawns new disciplines
of science. In addition, a new award--the NIH Director's Pioneer
Award--will support a select group of investigators who have the
potential for ground-breading discoveries. Ultimately findings from the
laboratory must reach the public, and the initiatives under the third
them--Re-engineering the Clinical Research Enterprise--are geared to
address the roadblocks to the conduct of clinical research and its
translation to patients. These initiatives include the exploration of
the ability to create and enhance interoperability among clinical trial
networks, the testing the feasibility of establishing a National
Clinical Research Associations program where community-based clinicians
are trained to participate in studies and play a role in augmenting the
transfer of research to their patients, and the assessment of patient-
reported chronic disease outcomes. Critical work continues in the area
of research policy analysis and coordination with an emphasis on
harmonization and standardization of policies and requirements
pertaining to clinical research. In addition, extension and expansions
of clinical research training programs extramurally and intramurally
have been initiated.
THE OFFICE OF AIDS RESEARCH
The Office of AIDS Research (OAR) coordinates the scientific,
budgetary, legislative, and policy elements of the NIH AIDS research
program. Our response to the epidemic requires a unique and complex
multi-institute, multi-disciplinary, global research program. Perhaps
no other disease so thoroughly transcends every area of clinical
medicine and basic scientific investigation, crossing the boundaries of
the NIH Institutes and Centers. This diverse research portfolio demands
an unprecedented level of scientific coordination and management of
research funds to identify the highest priority areas of scientific
opportunity, enhance collaboration, minimize duplication, and ensure
that precious research dollars are invested effectively and
efficiently, allowing NIH to pursue a united research front against the
global AIDS epidemic. Each year, OAR oversees the development of the
comprehensive NIH AIDS-related research plan and budget, based on
scientific consensus about the most compelling scientific priorities
and opportunities that will lead to better therapies and prevention
strategies for HIV disease. The Plan serves as the framework for
developing the annual AIDS research budget for each Institute and
Center; for determining the use of AIDS-designated dollars; and for
tracking and monitoring those expenditures. OAR identifies scientific
areas that require focused attention and facilitates multi-institute
activities to address those needs. OAR coordinates, monitors and
fosters plans for NIH involvement in international AIDS research and
training activities. OAR supports a number of initiatives to enhance
dissemination of research findings to researchers, physicians, patients
and communities. The fiscal year 2005 budget request for OAR is
$61,435,000.
THE OFFICE OF RESEARCH ON WOMEN'S HEALTH
The Office of Research on Women's Health (ORWH), the focal point
for women's health research for the Office of the Director,
strengthens, enhances and supports research related to diseases,
disorders, and conditions that affect women, and sex/gender studies on
differences/similarities between men and women; ensures that women are
appropriately represented in biomedical and biobehavioral research
studies supported by the NIH; and, develops opportunities for the
advancement of women in biomedical careers and investigators in women's
health research. The report, An Agenda for Research on Women's Health
for the 21st Century, provides a framework for the ORWH to collaborate
with the scientific and advocacy communities to address gaps in
knowledge about women's health and sex and gender factors in health and
disease. The fiscal year 2005 budget request of $41,577,000 includes an
increase of $626,000 over the fiscal year 2004 appropriation.
Research priorities for women's health emphasize the importance of
interdisciplinary research with collaboration and integration of
knowledge from multiple areas of scientific expertise; lifespan issues
and the continuum from intrauterine life into elderly years; health
disparities/differences and diversity among different populations or
subpopulations of women; and, sex/gender differences in health and
disease and therapeutic interventions at genetic, molecular, cellular,
and functional levels. Areas of research interest for 2005 include:
pathogenesis of diseases including prevalence/validation of sex
differences in diagnosis/treatment of disorders/diseases; clinical
trial methodology; mental health studies; new agents for management of
menopausal symptoms; treatments/interventions for diseases that show
enhanced clinical features in women; and other specific areas such as
CFS, and benign gynecologic disorders including uterine fibroids.
Special emphasis areas for women's health research include genetics/
pharmacogenomics, and the genetic, molecular and cellular bases for
action of pharmacologic agents known to have differential effects in
females; and, prevention and treatment, from basic biological factors
to effects of risk behaviors or interventions. There is expansion of
new research in the ORWH specialized centers of interdisciplinary
research in women's health and sex and gender factors, and the unique
ORWH interdisciplinary career development program in women's health
research that fosters the mentored development of junior faculty and
assists them in bridging advanced training towards a goal of research
independence. In addition, the ORWH has now implemented a new
Intramural Program on Research on Women's Health to focus on NIH
intramural women's health and sex and gender comparison research. The
ORWH continues to partner with Institutes and Centers to ensure
compliance with NIH policies for the inclusion of women and minorities
in clinical research, and that analyses by sex/gender are addressed by
investigators funded by the NIH.
THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH
The NIH has a long history of funding health-related behavioral and
social sciences research, and the results of this work have contributed
significantly to our understanding, treatment, and prevention of
disease. The Office of Behavioral and Social Sciences Research (OBSSR)
furthers NIH's ability to capitalize on the scientific opportunities
that exist in behavioral and social sciences research by providing
leadership in identifying and implementing research programs in
behavioral and social sciences that are likely to improve our
understanding of the processes underlying health and disease and
provide directions for intervention. OBSSR works to integrate a
behavioral and social science approach across the programs of the NIH.
The fiscal year 2005 OD budget includes $26,321,000 for OBSSR, an
increase of $415,000 over the fiscal year 2004 appropriation.
Many exciting scientific developments are occurring at the
intersection of behavioral and social science research and biomedical
research. It has become apparent that increasingly, scientific advances
are being made at the interfaces of traditional disciplines, and that
approaches to science are becoming more integrative. OBSSR has begun
development of a program to provide interdisciplinary training to
postdoctoral fellows in NIH intramural laboratories. This program would
provide a mechanism hereby an individual with a PhD in a behavioral or
social science discipline might acquire interdisciplinary training that
included biomedical research. Alternatively, someone trained in a more
traditional biomedical field would receive postdoctoral training that
included a behavioral or social science component. In addition to the
benefits to be realized by the individual trainees, this program would
also show NIH leading, by example, our Roadmap efforts to build
interdisciplinary Research Teams of the Future.
OBSSR is also developing an initiative to advance discovery of
scientific knowledge about eHealth technologies for health behavior
change and chronic disease management. Consumers, patients, and
providers are increasingly using eHealth applications, particularly the
Internet, to seek health information for themselves or family and
friends, communicate with others who have a similar disease or illness,
and to communicate with their health care providers. These technologies
offer people the ability to obtain health information at relatively low
cost, including those with limited or no access to health care
professionals or services, and historically underserved populations.
While the use of eHealth interventions is becoming widespread, these
techniques have yet to receive much rigorous evaluation. This
initiative's goal is to bring together components of NIH, the Robert
Wood Johnson Foundation and other public agencies and private
foundations in a ``meeting of the minds'' about the state of eHealth
evaluation research for health behavior change and chronic disease
management, future directions in the field, and the role of NIH and
others in developing a research agenda for this area.
Behavioral and social factors contribute significantly to racial
and ethnic health disparities. Consequently, OBSSR is committed to
developing better knowledge of specific pathways to health disparities
and to finding solutions. In February 2003, OBSSR published in the
American Journal of Public Health a set of papers presenting scientific
evidence of the effects of racial/ethnic bias on health and identifying
areas for future research to further explicate the relationship. The
papers were the product of an OBSSR meeting of approximately 100
leading scientists held in April 2002. Currently, OBSSR is convening
discussions among ICs regarding the role of social and behavioral
science in their health disparities research activities and avenues for
coordinated initiatives.
An effective way to ensure that results of behavioral and social
science improve our society's health involves incorporating these in
clinical practice. In order to start this process at an early stage in
the training of the next generation of physicians, OBSSR funded the IOM
to determine how to improve medical education. The results of this
study [April 2004] will inform a training initiative that OBSSR with
several ICs will launch this year.
THE OFFICE OF DISEASE PREVENTION
The primary mission of the Office of Disease Prevention (ODP) is to
stimulate disease prevention research across the NIH and to coordinate
and collaborate on related activities with other federal agencies as
well as the private sector. There are several other offices within the
ODP organizational structure.
The Office of Medical Applications of Research (OMAR) has as its
mission to work with NIH Institutes, Centers, and Offices to assess,
translate and disseminate the results of biomedical research that can
be used in the delivery of important health services to the public. The
Office of Disease Prevention (ODP) has several specific programs/
offices that strive to place new emphasis on the prevention and
treatment of disease.
In fiscal year 2005, the Office of Dietary Supplements (ODS) within
ODP requests a budget of $26,218,000, an increase of $414,000 over the
fiscal year 2004 appropriation. In fiscal year 2004, ODS published its
5-year Strategic Plan for 2004-2009, a major component of which is to
significantly expand efforts to address the role of dietary supplements
in reducing the risk for chronic diseases. It will continue to promote
the scientific study of the use of dietary supplements by supporting
investigator-initiated research in conjunction with other ICs at NIH
and stimulating research through conduct of conferences and through
presentations at national and international meetings.
ODS, in collaboration with the National Heart, Lung, and Blood
Institute and other NIH ICs, has sponsored a systematic review of the
relationship between omega-3 fatty acids and a series of clinical
indications, particularly coronary heart disease. Several reports will
be published in fiscal year 2004 based upon this review, which will
serve as the basis for planning further NIH research on omega-3 fatty
acids. Congressional language in recent appropriation reports directed
ODS to enhance an ongoing collaboration for the development,
validation, and dissemination of analytical methods and reference
materials for botanical dietary supplements. ODS works with other
partners in the public and private sectors to meet this objective. ODS
supports the National Health and Nutrition Examination Survey (NHANES),
conducted by the National Center for Health Statistics at the Centers
for Disease Control and Prevention, in order to provide more
information about dietary supplement use in the U.S. population.
This will inform future research about potentially important target
populations, such as children, women, and the elderly. Funding is used
to create and populate a database of dietary supplements, as well as to
support the measurement of blood levels of key metabolites associated
with dietary supplement use. ODS collaborates with USDA to develop an
analytically-based database of dietary supplement ingredients. ODS
collaborates with other federal agencies to develop an approach to
assessment of the health effects of bioactive factors in foods and
dietary supplements. In its continuing efforts to inform the public
about the benefits and risks of dietary supplements, ODS collaborates
with USDA on the International Bibliographic Information on Dietary
Supplements (IBIDS) database, which now includes a consumer-oriented
search strategy. It has also disseminated a database devoted to federal
funding of dietary supplement research, called CARDS, which is
currently populated with data about the NIH investment from fiscal year
1999-2002. ODS publishes Fact Sheets about vitamin and mineral dietary
supplements in collaboration with the NIH Clinical Center, as well as
Fact Sheets about botanical supplements.
Another component of ODP, the Office of Rare Diseases (ORD) was
formally established through the Rare Diseases Act of 2002, Public Law
107-280. The purpose of this Act is to increase the national investment
in the development of diagnostics and treatments for approximately 25
million patients with more than 6,000 rare diseases. A rare disease is
defined as one where fewer than 200,000 persons are affected in the
United States. The fiscal year 2005 budget request for ORD is
$15,787,600, an increase of $253,000 above the fiscal year 2004
appropriation.
Through its Extramural Research Program, the ORD supports a Rare
Diseases Clinical Research Network with NIH Institutes and Centers
(ICs). The major goals for the network include the systematic
collection of clinical information to develop biomarkers and new
approaches to diagnosis, treatment, and prevention of rare diseases,
and to promote training of new clinical research investigators in rare
diseases. ORD funded seven Rare Diseases Clinical Research Consortia
and one Data and Technology Resources Coordinating Center. The
consortia focus on urea cycle disorders, inborn errors of metabolism,
rare neurological channelopathies, idiopathic bone marrow failure
states and cytopenias, vasculitides, and defects in steroidogenesis.
The patient support organizations are closely integrated into the
consortia and the network.
The ORD Intramural Research Program promotes training in the areas
of clinical and basic research into rare diseases and in biochemical
genetics, fosters protocol-based initiatives into rare diseases not
currently investigated in the intramural program, assists in the
investigation of select, unique disorders of unknown etiology, provides
overall research support for diagnostics and therapeutics of rare
disorders, and supports five Bench-to-Bedside grants.
In its Scientific Conferences Program, in fiscal year 2004, the ORD
will cosponsor more than 70 scientific conferences on rare diseases.
The 460 conferences sponsored to date since 1995 have been shown to be
excellent venues to establish a research agenda for specific rare
diseases, take advantage of scientific opportunities, or eliminate
barriers to dvancing research.
To provide more comprehensive information, ORD, together with the
National Human Genome Research Institute (NHGRI), established the
Genetic and Rare Diseases Information Center to respond to requests for
information about genetic and/or rare disorders. In its third year of
operation, the information center broadened its language base to
include Spanish in addition to English.
In fiscal year 2004, ORD plans to establish a Trans-NIH Rare
Diseases Working Group to encourage collaborative research activities,
provide opportunities for input as new rare diseases research programs
unfold, and gather information about the rare disease research programs
supported by the ICs and Offices for mandated annual and biennial
reports.
THE OFFICE OF SCIENCE EDUCATION
The Office of Science Education (OSE) plans, develops, and
coordinates science education programs to strengthen and enhance
efforts of the NIH to attract young people to biomedical and behavioral
science careers and to improve science literacy in both adults and
children. The office's mission is to help people understand and use new
knowledge uncovered by the NIH in pursuit of better health for
everyone. The OSE works toward this mission by: creating programs to
improve science education in schools (the NIH Curriculum Supplement
Series); creating programs that stimulate interest in health and
medical science careers (the new LifeWorks Web site); creating programs
to advance public understanding of medical science, research, and
careers; promoting NIH educational resources and programs; and advising
NIH leadership about science education issues. All office programs
target diverse populations including under-served communities, women,
and minorities, with a special emphasis on the teachers of students
from Kindergarten through grade 12. The OSE works closely with NIH
institutes, centers, and offices on science education issues, and
maintains the OSE Web site as a source of information about available
resources and programs. http://science.education.nih.gov.
The NIH Curriculum Supplements series are National Science
Education Standards-based lesson plans that are distributed free to K-
12 teachers across the country. They incorporate the best of both
science and education communities, and are intended to update science
content and allow the teacher to incorporate the latest NIH research
into classroom instructions. Life Works is a new OSE Web site created
as a source of career information for students, teachers, counselors,
and parents. The site will allow exploration of the educational
requirements, knowledge, skills, and abilities required for over 100
health and medical science careers. The fiscal year 2005 Budget request
for OSE is $3,899,000.
LOAN REPAYMENT AND SCHOLARSHIP PROGRAM
The NIH, through the Office of Loan Repayment and Scholarship
(OLRS), administers the Loan Repayment and Undergraduate Scholarship
Programs. The NIH Loan Repayment Programs (LRPs) seek to recruit and
retain highly qualified physicians, dentists, and other health
professionals with doctoral-level degrees to biomedical and behavioral
research careers by countering the growing economic disincentives to
embark on such careers, using as an incentive the repayment of
educational loans. There are loan repayment programs designed to
attract individuals to clinical research, pediatric research, health
disparities research, and contraception and infertility research, and
to attract individuals from disadvantaged backgrounds into clinical
research. The AIDS, Clinical, and General Research Loan Repayment
Programs are designed to attract investigators and physicians to the
NIH's intramural research and research training programs. The NIH
Undergraduate Scholarship Program (UGSP) is a scholarship program
designed to support the training of undergraduate students from
disadvantaged backgrounds in biomedical research careers and employment
at the NIH. The fiscal year 2005 Budget request for OLRS is $7,250,000.
Thank you for giving me the opportunity to present this statement;
I will be pleased to answer questions.
______
Prepared Statement of Dr. Patricia A. Grady
Mr. Chairman and Members of the Committee: The fiscal year 2005
budget includes $139.198 million, an increase of $4.497 million over
the comparable fiscal year 2004 appropriation level.
I am pleased to be here today to discuss the activities of the
National Institute of Nursing Research (NINR). NINR supports research
that converges well with NIH's top priorities and activities. Our
research emphases are also reflected in the NIH Roadmap, the strategy
to accelerate scientific discoveries and take new approaches to make
them more rapidly available to patients. NINR's scientific community is
excited about the opportunities within the current and future NIH
Roadmap initiatives. NINR is already supporting important
interdisciplinary research training and interdisciplinary research,
including community-based research. NINR's scientific community has
been alerted to the procedural changes that need to take place in order
to capitalize on the NIH Roadmap initiatives; their enthusiasm predicts
a high level of support for the Roadmap.
From its inception, NINR has emphasized interdisciplinary research
teamwork and clinical and translational research, which are prominently
featured in the Roadmap agenda. Our studies address national health
problems head on. We have moved from an acute to a chronic disease
focus, with emphasis on older people, who are living longer with
illness and want the highest quality of life possible. We promote
ethnically and culturally sensitive research and are aggressively
pursuing research on health disparities, devoting about 20 percent of
our budget to this area of science.
control of high blood pressure in young inner-city african-american men
A good example of a program of research that improves health care
disparities in a vulnerable African-American population is located a
short distance from here--East Baltimore. The number of people with
hypertension nationally is 40 percent higher for African-Americans than
for Caucasians, and there is more severe disease impact among African-
Americans that can include heart enlargement and kidney dysfunction.
The Johns Hopkins School of Nursing conducted this unique hypertension
study, targeting a high-risk population of hypertensive young African-
American men between 21 and 54 years of age who are generally
considered underserved by the healthcare system. At the study's start,
only 17 percent had control of their blood pressure, but after three
years, 44 percent of the men receiving the intensive form of a
carefully designed community-based intervention attained control of
their blood pressure. In some cases, the study represented the first
time the study participants experienced formal healthcare. Of special
significance is that 90 percent of the young men were retained in the
study for the entire three-year period. A key to this success was the
culturally appropriate, multidisciplinary research team approach that
involved nurse practitioners, community health workers, and physicians.
Among the lessons learned from this research is the need to modify
healthcare for vulnerable populations like this one in Baltimore--
health care that involves home visits that offer educational and
behavioral counseling to supplement visits to the clinics, and
addresses factors beyond the disease itself, such as reducing substance
abuse and obesity.
HEALTH OF MINORITY, INNER CITY NEWBORNS IMPROVED BY NURSE HOME VISITS
Another example of a health disparity is infant mortality, with
rates for African-Americans twice those of Caucasians. Researchers
tested a carefully designed intervention tailored to the risks of the
populations studied to help close this health disparity gap. Findings
after one year of the project indicate that the health outcomes of both
mother and infant were improved, and costly health care was avoided.
The intervention involved focusing on low-income, pregnant African-
American and Mexican-American mothers from the inner city, who received
a program of planned prenatal care and post-natal monitoring with
teaching and counseling at each encounter. Home visits made by a team
of trained community residents and led by a nurse were an important
feature, and the mothers received monthly phone calls for a year after
their babies were delivered. The effects of the program varied by race
and ethnicity. For African-Americans, findings indicated that mothers
had more realistic expectations of their parenting role and were able
to document the immunization of their infants. Their infants' mental
development scores were higher than the control group. Mexican-American
mothers showed improved skills in dealing with everyday life and in
playing with their infants. This research and previous studies indicate
that home visits by a nurse-health advocate team are among the most
successful interventions in improving maternal and infant health--even
for-inner city, low-income minority families. The key is to implement
culturally sensitive interventions that are intensive and adequately
staffed and funded.
WOMEN'S EARLY WARNING SIGNS OF HEART ATTACK
Although heart disease is the number one cause of death in both
genders, far less is known by physicians and by women themselves about
how women experience the disease. Research focusing on women's symptoms
prior to heart attack found that women have different early warnings of
heart attach than men have. Of note is that most clinicians consider
chest pain as the most significant symptom for both sexes. Yet in this
study the most prevalent symptom was reported to be unusual fatigue (70
percent), followed by sleep disturbance (48 percent), and shortness of
breath (42 percent). Fewer than a third of the women reported chest
pain or discomfort. Even during the heart attack, 43 percent did not
experience chest pain. Clearly, women's symptoms appear to be different
from men's. This underscores the importance of women and clinicians,
both, recognizing early warning signs of impending heart attack in
women, so that they can prevent it or ease its effects.
CHOLERA REDUCED BY LOW TECH WATER FILTRATION
A growing global problem faced by developing nations is the
availability of healthy drinking water, a most basic need for life and
health. Cholera is carried by untreated surface water and kills
thousands of people around the world by causing severe vomiting and
diarrhea. The World Health Organization reports that the number of
countries with cholera is increasing. In our own hemisphere, cholera
incidence is now increasing in 16 Latin American nations. Researchers
in Bangladesh have found a simple preventive technique that works and
may be transferable to other countries. Inexpensive and widely
available cotton sari cloth, when folded four to eight times, creates a
filter small enough to remove most plankton, where cholera bacteria
often live. In 65 villages with 133,000 inhabitants, the number of
cholera cases was almost cut in half when people filtered their water
with the sari cloth. Cultural barriers were not an issue, and about 90
percent of the rural study participants followed the filtering
procedure. When cholera did occur, those villagers had drunk unfiltered
water at villages not participating in the study. The sari filtering
technique could work just as well using other types of inexpensive
cloth filters if replicated in countries where cholera is widespread.
THE NINR ROLE IN THE NIH ROADMAP
Last year, NINR developed what we call Research Themes for the
Future, which represent NINR priorities over the next five plus years.
These themes blend well with the NIH Roadmap overall, especially in two
areas--Interdisciplinary Research Teams of the Future, and Re-
engineering the Clinical Research Enterprise. In the first area, NINR
has considerable experience carrying out interdisciplinary team
research projects. In fiscal year 2003, more than half of NINR
investigator publications appeared in non-nursing journals. This
underscores the promise of future successful interdisciplinary research
and practice collaborations. It also indicates that many other
disciplines value nursing research findings. In the area of improving
the clinical research enterprise, most of NINR's research is clinical
in nature and can bring research questions to the laboratory from the
clinical researcher's perspective. Investigators also translate
research findings into the clinical practice of healthcare providers
and develop partnerships with communities to speed new scientific
knowledge into mainstream health regimens. Late last year, NINR
supported a national conference to promote research-intensive
environments in clinical settings, including academic medical centers
and those that are nontraditional as far as research is concerned, such
as nursing homes and community-level health enterprises. The goal was
to create partnerships between academic researchers and potential
investigators in these settings to develop resources and ease barriers
to innovative research.
To make the Roadmap a reality for nurse researchers, since the
Roadmap will not be business as usual, but business as usual plus, NINR
recently convened an implementation meeting with interdisciplinary
experts from across the country. The meeting addressed ways to
intersect NINR's themes and priorities with those of the Roadmap, as
well as suggestions for new Roadmap directions that reflect the
expertise of nursing research. Since NINR has always stressed
interdisciplinary research, we look forward to increased participation
in the Roadmap.
INITIATIVES
Looking ahead to our fiscal year 2005 initiatives, reduction of
obesity, a major public health issue, is certainly on the NINR agenda.
Pediatric and adolescent obesity is particularly disturbing in and of
itself, because it forewarns of future poor health. We plan to target
minority populations at risk for obesity and children who are
underserved--for example, those in rural areas. Research will address
biological, behavioral and social science factors leading to or
perpetuating obesity.
Our genetics initiative is novel for NINR, since it involves
incorporating behavioral, biological and molecular science into nursing
research. Our focus will be on the interactions between genes,
environment and behavior, including health promotion behavior. We will
also assess the results of genetic education and counseling, and the
effects of genetic testing on health, including lifestyle changes and
the reduction of risks for disease.
Increased attention is required to build the knowledge base for
effective end of life care. NINR is the lead Institute at NIH for end-
of-life research. The research agenda we have identified for better
healthcare management at this final stage of people's lives includes
improved methodology, instruments, communication, and interventions
that helped making choices. Previously published NINR-funded research
findings on symptom management are already being integrated into
standards of care. Further study is taking place to develop new
behavioral approaches to improve the lives of patients and their
caregivers and to devise new techniques to improve management of pain.
Self-management has become the most basic way people can improve
their lives when they are living with long-lasting, incurable chronic
illness. Successful self-management interventions tested in mainstream
populations, such as how to improve coping skills and how to maintain
and improve cognitive functioning, will be tested in populations with
special needs: the unemployed, homeless, very old, impoverished,
disabled, or geographically isolated.
Another initiative involves symptom management. Traditionally,
clinical practice treats symptoms one symptom at a time. Yet symptoms
rarely occur alone they occur in clusters. NINR plans to support
research that will identify and describe groups of symptoms in HIV/AIDS
and cancer patients by determining these clusters' effects on the
patient, and developing interventions to manage the multiple symptoms.
In addition to assisting how one symptom impacts the others in a
cluster, we will consider the effects of age, treatment, gender, and
type and stage of disease.
NINR will expand on past and current research initiatives that
focus on minority and underserved women's health, such as health
disparities and reduction of low birth weight among minority women. The
new initiative will focus on other aspects of women's health outside of
reproduction, which in the past was frequently the central focus of
women's health research by investigators of many disciplines.
INCREASING THE NUMBER OF NURSE INVESTIGATORS
The well documented and current shortage of nurses was preceded by
a significant shortage of nurse researchers. The shortage of nurse
researchers also means fewer nursing faculty to train future nurses and
to conduct research that provides the scientific base for healthcare
practice. In confronting this issue, NINR continues to collaborate with
universities nationwide to rapidly develop baccalaureate-to-doctoral
fast-track programs. This is in response to one of the recommendations
of the National Research Council four years ago, which urged
preparation of more nurse researchers more quickly. NINR revised the
predoctoral training mechanism to enable nurses to enroll in the many
fast-track doctoral programs in nursing which accept baccalaureate-to-
doctoral students. NINR has been responsive to the National Research
Council's recommendation, and the nursing community has also responded
by rapidly developing these baccalaureate-to-doctoral programs all over
the nation.
NINR supports Developmental and Core Centers to stimulate research
and research training opportunities. Creating partnerships and
leveraging funds is a hallmark of those Centers. We also initiated 17
Nursing Partnership Centers to Reduce Health Disparities, in
collaboration with the National Center on Minority Health and Health
Disparities. These Centers partner eight research-intensive
universities with nine minority-serving institutions. As a result of
this program, we expect health disparities research to expand and the
number of minority nurse investigators to increase.
NINR will continue to offer career development awards, and we will
make a special effort to train minority investigators through mentored
research scientist awards and research supplemental awards. NINR's
small but growing intramural research program is initiating a graduate
partnership program with universities across the country this year and
continues to support postdoctoral training opportunities on the NIH
campus.
In closing, the upcoming year contains new opportunities to
configure scientific research in new ways. NINR and the nursing
research community look forward to participation in the NIH Roadmap
initiative and in other research that directly impacts the improvement
of people's health.
Thank you, Mr. Chairman. I will be pleased to answer any questions
the Committee might have.
______
Prepared Statement of Dr. Barbara Alving
I am pleased to present testimony before this Committee on behalf
of the National Heart, Lung, and Blood Institute (NHLBI).
The NHLBI leads a national program directed at alleviating the
burdens of diseases of the heart, blood vessels, lungs, and blood. The
Institute also is responsible for research on the clinical uses of
blood and its products and the management of blood resources. For more
than a decade, the National Center on Sleep Disorders Research has been
part of the NHLBI and, since fiscal year 1998, the NIH Women's Health
Initiative has been administered by the Institute. Our diseases and the
burdens associated with them touch the lives of all Americans.
BASIC AND CLINICAL RESEARCH APPROACHES
The ultimate goal of the NHLBI is to improve the public health
through discovery of effective methods to prevent and treat disease.
Progress toward this goal depends on the existence of a coordinated
program that focuses on clinical investigation as the culmination of
basic research to unravel the fundamental processes that govern health
and disease. The Institute has fostered and sustained a longstanding
commitment to laboratory investigations of relevance to its mandate.
Moreover, in recent years it has allocated a significant share of the
generous budget increases provided to it to aggressive pursuit of
promising, cutting-edge opportunities in such disciplines as genomics,
proteomics, and nanotechnology. Advances in these areas promise to
enable, among other things, more specific approaches to health
promotion based on detailed assessment of individual characteristics
rather than on general observations about what does or does not foster
good health. Our optimism about the probable yield of these new
endeavors cannot be overstated.
However, the health-related outcomes of these basic science
endeavors depend greatly on the extent to which laboratory discoveries
are translated into approaches applicable to ``real-life'' health
problems. And that, in turn, depends on clinical research. Being a
disease-oriented agency, the NHLBI has for many years placed strong
emphasis on developing and maintaining a robust clinical research
portfolio. Particularly with regard to clinical trials, the Institute
has worked to design efficient, less costly research approaches to
evaluating therapeutic and preventive strategies. As part of this
effort, the NHLBI has developed and refined the ``clinical research
network'' concept and successfully applied it to evaluate new
therapeutic approaches to conditions such as pediatric cardiovascular
disease, asthma, acute respiratory distress syndrome, and Cooley's
anemia. The networks provide an infrastructure that enables rapid and
cost-effective testing of new therapies as they come to light.
THE NIH ROADMAP--CLINICAL RESEARCH
It naturally follows that the NHLBI is an enthusiastic participant
in the NIH Roadmap initiative titled Re-Engineering the Clinical
Research Enterprise: Feasibility of Integrating and Expanding Clinical
Research Networks. This new solicitation seeks to identify ways in
which clinical research networks can collaborate to conduct clinical
trials and other multicenter clinical research studies more efficiently
than the current system allows. We at the NHLBI believe that
application of lessons learned from this Roadmap initiative will better
position the Institute to accelerate the pace of research and to reduce
barriers that prevent research advances from becoming incorporated into
clinical practice.
POSTMENOPAUSAL HORMONE THERAPY
Major unexpected findings from the NIH Women's Health Initiative
(WHI) illustrate the critical importance of the randomized, controlled
clinical trial in determining the risks and benefits of preventive
strategies. The study, which assessed the role of estrogen therapy,
with or without added progestin, in preventing major causes of death
and disability among postmenopausal women, was predicated on strongly
suggestive evidence from basic research, observational studies, and
smaller clinical trials that often measured so-called surrogate end
points (e.g., changes in heart disease risk factors or subclinical
manifestations), rather than events such as heart attacks or deaths
from coronary disease. Indeed, at the outset of the WHI, much doubt
existed regarding the feasibility and ethics of conducting the trial,
because ``everybody'' already ``knew'' that hormone therapy helped
women remain youthful and ``feminine forever,'' by not only relieving
troublesome menopausal symptoms but also improving general health. Much
to the surprise of researchers, practicing physicians, and women
themselves, the trial of estrogen plus progestin last year was halted
when it found increased risks of heart attack, stroke, invasive breast
cancer, and blood clots among women assigned to take hormones. And
quite recently, the estrogen-alone part of the study was discontinued
because the hormone did not appear to have the hoped-for beneficial
effect on heart disease (or, on the other hand, the feared unfavorable
effect on breast cancer), but it did increase risk of stroke. These
findings have major public health significance: the conclusion is that
postmenopausal hormones, once ranking among the most-prescribed
preparations in the United States, should generally be used only for
short-term alleviation of menopausal symptoms.
LUNG-VOLUME-REDUCTION SURGERY (LVRS)
Another trial of great practical importance was a rigorous
assessment of LVRS, a procedure that was first used to treat emphysema
during the 1950s. Although some patients seemed to benefit from this
radical and invasive procedure, high mortality and morbidity
discouraged its widespread use until the early 1990s, when some
surgeons began performing LVRS again and insurance reimbursement became
one of several issues demanding resolution. The National Emphysema
Treatment Trial (NETT) clarified the short-and long-term risks and
benefits of LVRS and identified the characteristics of patients who may
be most likely to benefit from LVRS, as well as those who are at
greater risk of death and complications from the procedure. The NETT
reflects a unique relationship in which the NIH funded and administered
the study and the Centers for Medicare and Medicaid Services (CMS),
which sought evidence regarding the advisability of providing Medicare
reimbursement for LVRS, supported participants' care costs.
Additionally, the Agency for Healthcare Research and Quality
contributed support for analysis of the cost-effectiveness of LVRS. The
study results have provided a scientific basis for reassessment of
Medicare coverage for LVRS.
TRIALS OF HYPERTENSION CONTROL AND PREVENTION
Last year, we reported results from the ALLHAT (Antihypertensive
and Lipid-Lowering Treatment to Prevent Heart Attack Trial), which
found persuasive evidence that traditional diuretics should be the
initial treatment of choice for lowering high blood pressure. This is a
study that only the NIH would likely have undertaken, as the comparison
drugs--a calcium channel blocker and an ACE (angiotensin-converting
enzyme) inhibitor--were already established as blood-pressure-lowering
agents; it further illustrates the unique role played by the NIH in
addressing issues of public health importance. Of additional interest
is the observation that blood pressure control rates among ALLHAT
participants increased from 25 percent at the beginning of the ALLHAT
to 66 percent after five years of followup. These gains were achieved
in a variety of clinical practice settings and in subgroups of people
known to experience difficulty with blood-pressure control, such as
blacks, the elderly, and diabetic patients. These results offer
encouragement that blood pressure control is obtainable, and they
challenge us to pursue this goal vigorously.
The ALLHAT findings, in combination with evidence from other
research studies, prompted issuance of an updated set of guidelines for
hypertension management--the so-called JNC 7, or Seventh Report of the
Joint National Committee on Prevention, Detection, Evaluation, and
Treatment, of High Blood Pressure. An important feature of the
guidelines is a reclassification of blood pressure levels that includes
the new category ``prehypertension'' (120 to 139 mm Hg systolic and/or
80 to 89 mm Hg diastolic blood pressure). Individuals with
prehypertension are strongly encouraged to pursue lifestyle changes--
losing excess weight, eating a heart-healthy diet, increasing physical
activity, quitting smoking--to forestall development of overt
hypertension. To date, most behavioral interventions have focused on
only one or two lifestyle changes at a time. However, findings from a
recent clinical trial indicate that an all-in-one approach to lifestyle
changes is feasible and effective in lowering blood pressure. Trial
participants who addressed many elements of a healthy lifestyle
simultaneously also significantly reduced their weight and became more
fit providing even more incentive to undertake such changes.
HYDROXYUREA THERAPY FOR SICKLE CELL DISEASE
A breakthrough for patients occurred in 1995 when the NHLBI
announced the results of a major trial of the first treatment for
adults with sickle cell disease. The study found that use of the drug
hydroxyurea slashed rates of painful crises and acute chest syndrome,
and sharply reduced the need for blood transfusions and
hospitalizations. A followup study of the trial participants recently
reported that hydroxyurea not only protects patients from episodes of
severe illness associated with their disease, but also prolongs their
lives. Even the sickest patients--those who suffered three or more
painful crises a year--benefitted. These results have important
implications both for improving patient care and for decreasing health
care costs associated with sickle cell disease.
IMPROVING SURVIVAL FOR VICTIMS OF CARDIAC ARREST
Cardiac arrest--in which the heart stops beating effectively, blood
does not circulate, no pulse can be felt, and the victim collapses into
unconsciousness--is a frequent occurrence in this country. Despite
several decades of efforts to train members of the public to perform
CPR (cardiopulmonary resuscitation), few victims of out-of-hospital
cardiac arrest survive the experience. The NHLBI Public Access
Defibrillation trial trained volunteer rescuers to use an automated
external defibrillator, a device that shocks the heart back into normal
rhythm. It found that use of CPR plus the defibrillator, compared with
use of CPR alone, markedly increased survival of people who suffered
cardiac arrest in various community settings, and caused no major
injuries or serious safety problems. An important next step, currently
under way with NHLBI support, is to determine the safety and
effectiveness of providing defibrillators to families of heart attack
patients for use when a cardiac arrest occurs at home. In addition, the
Institute is establishing a research consortium of investigators,
hospitals, emergency medical services, and local communities to
investigate promising experimental strategies to resuscitate patients
who experience out-of-hospital cardiac arrest.
COMBATING THE OBESITY EPIDEMIC
Obesity is a problem of great concern to the NHLBI, as it strongly
influences the risk for developing diseases and conditions such as
coronary heart disease, hypertension, and diabetes. Thus, the Institute
is strongly involved in the overall NIH effort to reverse the U.S
obesity epidemic, and I have been especially pleased to serve as
cochair of the NIH Obesity Research Task Force.
The NHLBI recently launched a major study that addresses one of the
most challenging aspects of weight control--keeping lost pounds off.
The Weight Loss Maintenance Trial will initially assist overweight or
obese adults participants in making lifestyle changes to reduce their
weight and, subsequently, it will test various strategies to help the
participants maintain their weight loss over the next several years.
The trial focuses on persons who are being treated for high blood
pressure or high blood cholesterol and, consequently, have particularly
strong reasons to achieve and maintain a healthy weight.
Another new initiative will assess the effectiveness of worksite
interventions for preventing or controlling overweight and obesity in
adults. Strategies to be considered include implementing environmental
and policy changes to increase employees' physical activity (e.g.,
flextime or fitness-center discounts), offering healthful food choices
in cafeterias and vending machines, providing information about
nutrient and calorie content of foods at the point of purchase, and
enhancing social support from fellow workers to encourage improved diet
and physical activity.
A third NHLBI initiative will explore the potential use of
bioengineering approaches to address problems of obesity. For example,
new methods for imaging body fat content may enable more specific
identification of who needs to lose weight and their success in doing
so. Bioengineering techniques may also offer a solution to the
difficult technical challenge of obtaining precise measurements of
energy intake and expenditure. One can envision development of a
wristwatch-like gadget from which the wearer could easily determine
whether an energy intake goal has been exceeded or an energy
expenditure has been met. New approaches might provide accurate,
convenient, easily understood, and inexpensive devices that would
foster research, improve clinical management of adults and children,
and help the public eat less and exercise more.
CONCLUSION
These examples illustrate the extraordinary potential of clinical
research, and particularly clinical trials, to address issues of major
importance to the public health. The NHLBI will continue its commitment
to stimulate and support clinical research, and to ensure that the
knowledge thereby gained is rapidly, efficiently, and fully applied to
disease treatment and prevention.
BUDGET STATEMENT
The fiscal year 2005 budget includes $2,963.9 million, an increase
of $172.1 million over the fiscal year 2004 enacted level of $2,791.8
million.
I would be pleased to answer any questions that the Committee may
have.
______
Prepared Statement of Dr. James F. Battey, Jr.
Mr. Chairman and Members of the Committee, I am pleased to present
the President's budget request for the National Institute on Deafness
and Other Communication Disorders (NIDCD). The fiscal year 2005 budget
includes $393,507,000 which reflects an increase of $11,561,000 and a 3
percent increase over the fiscal year 2004 final conference level.
Disorders of human communication exact a significant economic, social,
and personal cost for many individuals. The NIDCD supports research and
research training in the normal and disordered processes of hearing,
balance, smell, taste, voice, speech, and language. NIDCD's mission
includes the support of research to create assistive devices which
substitute for lost and impaired sensory and communication function.
Equally important to the NIDCD mission has been the discovery of
genetic mutations that affect communication disorders. This work would
not have been possible without the completion of the Human Genome
project, supported in part by the National Institutes of Health.
Enabled by this landmark accomplishment, scientists supported by the
NIDCD have been studying the genes responsible for non-syndromic (not
associated with any other problem) hereditary hearing impairment.
Within the last 8 years, 54 genes have been identified, largely due to
the contributions of NIDCD. Scientists are now focusing their efforts
on identifying more genes, learning what role the genes have in
deafness, and determining which genes affect certain populations of
individuals. For example, recent studies have demonstrated that
particular ethnic groups carry specific genetic mutations. Studying the
genes that cause non-syndromic hereditary deafness will also permit
early and more accurate genetic testing and foster the development of
innovative intervention and prevention strategies, and more effective
treatment methods for individuals with deafness and other communication
disorders. My testimony today will primarily focus on the many genetic
discoveries that have allowed NIDCD-supported scientists to learn more
about the causes of communication disorders, a first step in prevention
and treatment.
NEW WAY TO IDENTIFY USHER SYNDROME IN CHILDREN
Usher syndrome Type 1 is an inherited disorder. Children born with
this disorder are deaf, suffer balance problems, and gradually lose
their vision. Although Usher syndrome affects individuals of other
racial and ethnic backgrounds, scientists have recently identified a
clear pattern of its inheritance in Ashkenazi Jews, who are descendants
of Jews from Germany, Austria and Eastern Europe. In 2003, a NIDCD-
supported scientist identified a mutation within the gene known to be
responsible for Usher syndrome. The particular mutation seems to be
responsible for most of the Usher syndrome seen in Ashkenazi Jews.
Because scientists now know which mutation is responsible for this type
of Usher syndrome, they can develop genetic tests to detect the
mutation in Ashkenazi Jewish children who are born deaf. By identifying
children destined to lose their sight, parents and doctors can help
them learn to communicate and prepare them for blindness. Some of these
children will be appropriate candidates to receive a cochlear implant.
Cochlear implants are small electronic devices that enable individuals
who are deaf or have severe hearing loss to detect sound. This research
will now enable doctors to provide important quality of life
improvements for children with Usher syndrome.
GENE REPLACEMENT THERAPY CAN GENERATE NEW HAIR CELLS
The sensory hair cells of the inner ear play an important role in
detecting sound. People who lose hair cells due to excess noise,
infections, or accidents often lose some or all of their ability to
hear. Scientists have determined that many forms of inherited deafness
are also due to problems with hair cells. The hair cells of the inner
ear act like miniature amplifiers. Sound waves that enter the inner ear
are converted into a series of chemical and electrical signals within
the cells. These signals are ultimately transmitted to the brain via
the auditory nerve and interpreted as sound. In the past, only birds or
reptiles were thought to be capable of generating new hair cells. Now,
NIDCD-supported scientists have discovered a way to use gene therapy to
generate new hair cells in the ears of adult mammals. Scientists used a
virus to transfer a gene called Math1 into the ears of guinea pigs.
Math1 is expressed in developing hair cells, and its expression is
thought to cause the cells to become hair cells, rather than becoming
another cell type within the ear. The virus infects cells of the ear
and causes them to produce the Math1 protein. Early experiments suggest
that when the virus infects cells that do not normally express Math1,
some of these cells become hair cells. In addition, the new hair cells
also attract fibers of the auditory nerve, suggesting that the new
cells may also be able to establish a link to the part of the brain
that interprets sound--the auditory cortex. If this work can be
duplicated in human beings, it may be the first step towards enabling
scientists to use gene therapy to restore hearing to those who have
lost it, or to enable deaf individuals to hear.
NEW SHORT ELECTRODE WILL ALLOW GREATER BENEFIT FROM COCHLEAR IMPLANTS
Cochlear implants are commercially available miniature hearing
prostheses capable of assisting those who are profoundly deaf or
severely hearing impaired. Approximately 60,000 individuals all over
the world have received cochlear implants. The implant bypasses damaged
or missing hair cells to send electrical signals through an array of
electrodes within the cochlea (inner ear). Current cochlear implants
send sound information that covers the entire frequency range. In order
to send both high and low frequency information, the electrodes of the
cochlear implant are inserted as far into the cochlea as possible.
Unfortunately, inserting the electrodes into the cochlea compromises
any residual (remaining) hearing the individual may have had prior to
implantation. Consequently, scientists developed a new shorter
electrode to help an additional population of individuals with hearing
loss. These individuals have a considerable amount of residual hearing
and their primary hearing loss is in sounds in the high frequency
range. They are also experienced, yet unsuccessful, adult hearing aid
users with severe-to-profound hearing impairment who would not have
been conventional cochlear implant candidates. The short electrode is
inserted into the base (or bottom) of the cochlea to restore hearing at
high frequencies, while preserving low frequency hearing, or residual
hearing, in the apex (or top) of the implanted ear.
The preliminary data demonstrates residual hearing can be preserved
with this short electrode, and provides evidence that this is most
beneficial for understanding speech in a noisy background. Furthermore,
the innovative short electrode may be an ideal treatment for those with
presbycusis, which is the loss of hearing that gradually occurs in most
individuals as they grow older. This new electrode design allows many
more people with some degree of hearing loss to benefit from cochlear
implant technology.
IDENTIFYING GENES IMPORTANT FOR THE SENSE OF TASTE
The worldwide obesity epidemic is causing health professionals to
focus their attention on how people choose which foods to eat. Because
taste plays an important role in food choice, scientists are interested
in figuring out how taste buds tell the brain that they have tasted
something, and which taste genes are responsible for sensing different
food flavors. Vegetables such as broccoli, cauliflower, cabbage, and
brussels sprouts contain compounds related to phenylthiocarbamide
(PTC). For more than 50 years, scientists thought that the ability to
taste PTC and similar compounds was determined by a single gene. If an
individual inherited the PTC-tasting version of the gene, then they
detected its bitter taste. If the tasting version of the gene was not
inherited, the compound had no taste to that individual. Now NIDCD
scientists, in collaboration with scientists in California and Utah,
have identified a gene that regulates a person's sensitivity to the
bitter taste of PTC. This explains why people seem to demonstrate a
range of sensitivity to PTC's taste and may even influence whether or
not an individual likes to eat broccoli and other vegetables containing
PTC-like compounds. Because they determine an individual's sensitivity
to a particular taste, inherited genes probably influence food choices.
In the future, doctors may now be able to use this knowledge as part of
a strategy to prevent and treat obesity and to overcome poor nutrition
due to poor food choices. Increased knowledge about how taste cells
tell the brain that they have detected a particular flavor may also
help doctors restore the sense of taste to those who have lost it due
to injury, disease or aging.
VOCAL FOLD PARALYSIS
Vocal fold paralysis is a genetic disorder that can be inherited.
The vocal folds are two bands of smooth muscle tissue that lie opposite
each other and are located in the larynx or voice box. When at rest,
the vocal folds are open to allow an individual to breathe. Voice is
produced by vibration of the vocal folds. To produce voice, air from
the lungs passes through the folds, causing vibration and thus making
sound. The sound from this vibration then travels through the throat,
nose, and mouth (resonating cavities). The size and shape of these
cavities, along with the size and shape of the vocal folds, help to
determine voice quality. Paralysis of the vocal folds impacts voice
quality and inhibits an individual's ability to communicate. This
disorder can also cause life-threatening breathing difficulties in
affected newborn infants.
Intramural scientists at the NIDCD and the National Institute of
Neurological Disorders and Stroke are studying a family in which this
disorder occurs and have found that vocal fold paralysis is due to
degeneration of the nerves involved in movement. Weakness in the
muscles of the arms and legs can also accompany this disorder. In the
study, genetic analyses were used to locate the site of the causative
gene to a section on chromosome 2. Further studies revealed that
mutations in the dynactin gene, which resides at this location, are
responsible for this disorder. Dynactin is a molecule that helps
transport materials within nerve cells, and this research finding
suggests that dynactin transport is essential for health and
maintenance of at least some motor nerve cells.
This finding allows for a genetic tool for diagnosing vocal fold
paralysis, which can aid in the clinical and neonatal management of
this disorder. In addition, these findings provide better understanding
of motor nerve cells and the molecular mechanisms that cause motor
nerve degeneration.
NIH ROADMAP
The NIH Roadmap initiative to support interdisciplinary research
and research training will advance the NIDCD mission because it
encourages collaboration of scientists from seemingly unrelated
disciplines. Interdisciplinary collaborations from a variety of
scientific disciplines are necessary for developing assistive
communications devices such as hearing aids and cochlear implants. The
success of the development of the cochlear implant is a good example of
successful interdisciplinary research as it involved the effort of
physicists, chemists, material scientists, psychologists
otolaryngologists, audiologists, speech-language pathologists,
electrical engineers, and biomedical engineers We look forward to
expanding upon that type of research in the coming years.
Finally Mr. Chairman, I would like to thank you and Members of this
Committee for giving me the opportunity today to speak to you about the
exciting recent discoveries from the NIDCD. I am pleased to answer any
questions that you have.
______
Prepared Statement of Dr. Donald A.B. Lindberg
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Library of Medicine
(NLM) for fiscal year 2005, a sum of $325,147,000, which reflects an
increase of $16,671,000 over the comparable fiscal year 2004
appropriation.
The National Library of Medicine continues to be the premier source
of science-based medical information. Just 10 years ago the Library
introduced its Web site one of the very first in the federal government
and so began a decade of amazing growth in the amount and variety of
medical information it made available. Today the Library's Web service
not only provides free access to Medline/PubMed, the largest and most
reliable database of scientific medical information in the world, but
NLM has created information products designed specifically for
patients, families, and the public.
Despite its recent successes, NLM believes that the surface has
barely been scratched and that the future holds the promise of many
more valuable information products for the professions and the public.
The Library's communications experts are at the cutting edge of new
technology and, as more and more users have access to ever more
powerful networks, the Library will put in place sophisticated yet easy
to use information services that allow users free access to the world's
burgeoning base of science-based health information. For scientists
this means access not only to the growing published journal literature,
but also electronically to scientific monographs and textbooks and to a
variety of genomic information resources through NLM's National Center
for Biotechnology Information (NCBI). For the general public, this
means making even more consumer health information--from the National
Institutes of Health and other reliable sources--available from the
NLM's Web site.
The new NIH Roadmap Initiative has the potential to have a profound
and positive impact on how American medical research is conducted. The
NLM sees itself has having an important role in the Initiative in three
areas. Because the Roadmap recognizes that one of the most powerful and
unifying concepts of 21st century biology is that of bioinformatics,
the computerized bioinformatics databases and analysis tools of the
NCBI will become even more central to the research enterprise. Second
is the Roadmap's requirement to ``re-engineer the national clinical
research enterprise.'' NLM's leadership role in working with biomedical
vocabularies the Unified Medical Language System, the recently
announced arrangement with the SNOMED clinical vocabulary, and NLM's
expanding the NIH clinical trials database are all key aspects of
improving clinical research. Finally, the Roadmap articulates NIH's
responsibility to communicate research results to improve the quality
of life for all people. The Library has a central role in collecting
and communicating these results through Web-based information services
and online databases. These are described in what follows.
TOOLS FOR SCIENTISTS AND HEALTH PROFESSIONALS
The NLM's Medline/PubMed is the most-used database of peer-reviewed
medical information in the world. It contains more than 12 million
references and abstracts to the world's medical literature published
since the 1960s; an ancillary ``OldMedline'' extends the coverage back
to the early 1950s. Each year millions of scientists and health
professionals connect to Medline/PubMed (no registration or fee is
required) and search for information they can use in the research or
practice. More than a half billion such searches are done every year.
The newest system, introduced in 1997, is constantly being improved.
Several years ago NLM introduced links between Medline/PubMed
references and publisher websites so users could retrieve the full text
of articles. Today, more than 4,000 of the database's 4,600
publications have such links.
Another heavily used database is GenBank, the repository of all
publicly available DNA sequences sent to the NLM from laboratories
around the world. GenBank, and an increasing array of other valuable
data resources, is the responsibility of the National Center for
Biotechnology Information. The Center, which was created by the
Congress in 1988 with the mandate to manage and disseminate genetic
data, coordinates closely with the NIH Human Genome Project. GenBank
today contains more than 27 million sequence entries totaling 33
billion base pairs from over 130,000 species. NLM, through the Web
operations of the NCBI, receives more than a quarter million visitors a
day seeking molecular biology information ranging from DNA sequences
and protein structures to the related research literature.
A repository for chemical structure and assay data has been
suggested as one aspect of NLM's involvement with the NIH Roadmap
Initiative on ``small molecules'' to enhance research and develop new
therapies. The NCBI is working on such a repository--called PubChem--
which will integrate into one open database, information from existing
chemical structure databases at various NIH institutes as well as data
supplied from industry and academic centers. By providing chemical
structure validation and structure-structure matching and by linking to
descriptions of the compounds in journal articles, PubChem will play an
invaluable role in making this information useful to scientists.
PubMedCentral, a digital archive, is an important component of the
infrastructure needed to enhance access to the life sciences
literature. Publishers electronically submit peer-reviewed research
articles, essays, and editorials. NLM guarantees free access to the
material; copyright remains with the publisher or the author. Access to
PubMedCentral is free and unrestricted. The full text of more than 100
life science journals, some going back decades, is now available, and
more are added as they sign on to the system. Digitally archiving the
scientific literature and guaranteeing access for future generations is
an important NLM responsibility.
INFORMATION SERVICES FOR THE PUBLIC
The National Library of Medicine has become a favorite destination
of seekers of health-related information on the Web--people looking for
answers to questions about their health or the health of their loved
ones. MedlinePlus, the largest of NLM's Web offerings for the general
public, now receives about 4 million unique visitors a month.
Increasingly, they also find their way on the NLM Web site to other
services created specifically for them--NIHSeniorHealth.gov,
ClinicalTrials.gov, Genetics Home Reference, Household Products
Database, and Tox Town are all recent examples. These Web sites contain
or point to information created by NIH components and other reliable
noncommercial sources. They require NLM librarians and information
specialists to work closely with a wide variety of outside
organizations. MedlinePlus, launched in November 1998, today is one of
the most heavily trafficked Web sites containing health information for
the public. It has more than 650 ``health topics,'' containing, for
example, overview information, pertinent clinical trials, alternative
medicine, prevention, management, therapies, the latest research, and
the latest news from the print media. There are even links to the
scientific literature through Medline/PubMed. In addition to the 650
health topics, there are medical dictionaries, encyclopedias,
directories of hospitals and providers, and interactive ``tutorials''
with images and sound. MedlinePlus en espanol was introduced in 2002
and has grown to virtual parity with the English version. Both scored
the highest marks of any Federal Web site in a recent outside
evaluation. A new aspect of MedlinePlus is its plan to ``Go Local,''
that is, to link users with community helping services near them. North
Carolina is the first MedlinePlus partner to go local.
The National Library of Medicine is collaborating with the American
College of Physicians in a unique ``Information Rx'' project that seeks
to encourage practicing physicians who are members of the College to
``prescribe'' MedlinePlus to their patients who need further
information on a medical subject. After test runs in Georgia, Iowa,
Virginia, and Florida, the Information Rx program will go nationwide
later in 2004.
MedlinePlus is not the only NLM information service directed at the
consumer. Another very popular resource is ClinicalTrials.gov, which
integrates previously fragmented information on human studies for
different conditions into a single, coherent system, providing the
public with an easy-to-use and convenient ``one-stop'' site for
comprehensive information on clinical trials. The site, which is used
not only by the public but by their health care providers, currently
includes information on approximately 8,800 trials for hundreds of
diseases and conditions conducted in about 90 countries.
ClinicalTrials.gov receives approximately 16,000 visitors daily and
over 3 million page views monthly.
Late in 2003 another service for the public was launched:
NIHSeniorHealth.gov. This site contains information in a format that is
especially usable by seniors. For example, the site features large
print and easy-to-read segments of information repeated in a variety of
formats--such as open-captioned videos and short quizzes to increase
the likelihood it will be remembered. NIHSeniorHealth.gov has a
``talking'' function, which allows users the option of reading the text
or listening to it as it is read to them. Another new NLM consumer
service is the Household Products Database. This is a guide that
provides easy-to-understand information on the potential health effects
of more than 2,000 ingredients contained in more than 4,000 common
household products. The database provides information on many of these
substances and their potential health effects, in consumer-friendly
language. For more technical information, users can launch a search for
a product or ingredient from the product's page into NLM's TOXNET, a
cluster of databases on toxicology, hazardous chemicals, and related
areas.
Another consumer health information resource introduced in 2003 is
the Genetics Home Reference. Genetics is a complex subject, and much of
the primary data and literature are difficult to understand without
formal training. The Genetics Home Reference Website augments
MedlinePlus with summaries of genetics information and an overview of
the fundamentals of genetic science. The user can browse by a specific
disease/condition or by gene. It also has a geographic list of genetic
counselors and information for care-givers. The database has more than
100 condition summaries and 80 gene summaries and new content is being
added continuously.
The Library launched Tox Town late in 2002. Tox Town looks at an
ordinary town and points out many environmental hazards that might
exist there. Users can click on a town location, like the school, and
see a colorful dollhouse-style cutaway view of that building. Toxic
chemicals that might be found in the school are listed, along with
links to selected Internet resources about school environments. There
are similar cutaways for offices, factories, parks, and other
locations. NLM has plans to add new scenes, such as an urban community
and a farming region.
SERVING SPECIAL COMMUNITIES
With all these unique information resources, it becomes more and
more important for the Library to engage in outreach to let citizens
know what is available. The 5,100-member National Network of Libraries
of Medicine is an important partner in these outreach endeavors. Many
of the programs are directed at minority populations. For example,
there are programs to assist in remedying the disparity in health
opportunities experienced by African Americans, Latinos, Native
Americans, senior citizens, and rural populations. A new NLM database
introduced in 2003 has health information aimed at Asian Americans;
2004 will see a similar database with information about the health
concerns of Native Americans.
Under a program with the Historically Black Colleges and
Universities (HBCUs), NLM is helping to train people to use information
resources in dealing with environmental and chemical hazards. The
latest aspect of this outreach effort is NLM's collaboration with the
United Negro College Fund Special Programs Corporation to work with the
HBCUs in the area of consumer health to encourage the use of reliable
electronic health information (such as that provided by the NLM) by the
public.
NLM also has been instrumental in reaching out to other countries
around the world to help improve their access to scientific medical
information. The oldest such program is that involving formal
partnerships with major institutions in 20 countries. The NLM helps
them obtain computerized access to the literature; the countries in
turn help NLM receive the medical literature from that part of the
world. The Library is also a key player in the Multilateral Initiative
on Malaria, the multiagency effort to improve malaria research in
African nations. NLM's role is to establish and maintain the first
malaria research communications network, MIMCOM. There are now 19
research sites in 9 countries participating, with full access to the
Internet.
SCIENCE ADVANCES
Many scientists believe that molecular biology is the primary
driver of medical advances in the 21st century. The rapidly increasing
volume of molecular data and the need to decipher its cryptic and
subtle patterns has created demanding requirements for computerized
databases and analysis tools, special curatorial expertise, and unique
physical facilities. The National Center for Biotechnology Information
is a key player in ensuring that the outpouring of data from molecular
biology laboratories around the world is turned to life-enhancing
purposes. GenBank, as noted above, is growing rapidly with
contributions received from scientists around the world. Scientists
also avail themselves of sophisticated computational tools, such as the
BLAST suite of programs, which lets scientists search enormous
quantities of data for sequence similarities that will identify genes
and genetic features. Another tool, Entrez, allows users to search DNA
sequences and literature information with techniques that are fast and
easy to use. The newest tool is the ``Reference Sequence Collection,''
which provides a centralized, integrated, non-redundant set of
sequences that is integrated with other information for all major
research organisms. Using the Reference Sequence Collection, time once
spent on having to identify, gather, and analyze data can now be spent
effectively on research.
The Center is now also conducting research using the human genome
sequence to begin exploring the history of human populations. NCBI
researchers, working with other collaborators, first assembled a set of
500,000 high-confidence variations and then compared the distribution
of these variations on the genome to that predicted by several models
of population history. They found that the data best fit a model in
which the human population shrank dramatically about 40,000 years ago,
a time when modern humans first appeared in Europe. The model suggests
that the population subsequently grew about 30,000 years ago,
consistent with archaeological evidence of a population expansion
during that period. The results indicate that databases of genetic
variation constructed alongside the human genome project can provide a
unique insight into the history of human populations. This insight may
also explain how these populations may respond differently to selective
pressures such as infectious diseases.
NLM's Lister Hill National Center for Biomedical Communications
sponsors high-technology communications research projects in such areas
as high quality imagery, medical language processing, high-speed access
to biomedical information, developing intelligent database systems,
multimedia visualization, data mining, and machine-assisted indexing.
One prominent area of research has been the Visible Human Project. The
project consists of two enormous (50 gigabytes) data sets, one male and
one female, of anatomical MRI, CT, and photographic cryosection images.
These data sets are available through a free license agreement to 1,800
individuals and institutions in 47 countries where they are being used
in a wide range of educational, diagnostic, treatment planning, virtual
reality, artistic, and industrial applications. An ``Insight Toolkit''
has been developed and makes available a variety of open source image
processing algorithms for computing segmentation and registration of
medical data. The Visible Human Web site is one of the most popular of
all NLM's Web offerings.
NLM's Extramural Programs for more than 20 years has supported the
training of medical informaticians at universities across the nation.
In the early years the program focused on training of informaticians
for clinical care. Today the training programs have added opportunities
for training in bioinformatics, the field of biomedical computing for
the large datasets characteristic of modern research. At present, NLM
provides 18 grants to biomedical informatics training at 26
universities, supporting 250 trainees. NLM also participates in the NIH
Roadmap activities, almost all of which have major emphasis on
biomedical computing. For example, training is an important requirement
of the National Centers for Biomedical Computing, an initiative for
which NLM is one of the key leaders. Training as embedded in Roadmap
activities is expected to become a significant complement to NLM's
traditional support of informatics training.
THE FUTURE
In its role as the world's largest medical library, the NLM will
continue to provide free access to the enormous literature of the
health sciences, including even priceless historical treasures dating
to the 11th century. As to the 21st century, the Library is making
major contributions to the NIH Roadmap and is also applying its
unparalleled collections and talents to ``BIOSHIELD,'' the Department
of Health and Human Services' effort to combat bioterrorism. The
ability to apply medical knowledge to make our citizens healthy and
safe is to repay the investment of the nation in medical research. In
this, the National Library of Medicine can be of great help.
______
Prepared Statement of Dr. Ting-Kai Li
I am pleased to present the President's budget request for the
National Institute on Alcohol Abuse and Alcoholism (NIAAA) for fiscal
year 2005, a sum of $441,911,000, which reflects an increase of
$13,486,000 over the comparable fiscal year 2004 appropriation.
As the recent NIAAA National Epidemiologic Survey on Alcohol and
Related Conditions (NESARC) has shown, most cases of alcoholism are
established by age 25, beginning as early as age 18.\1\ These new
results, which are corroborated by studies not yet published, call for
a major refocusing of research on youth as the most important target
for preventing alcohol abuse and alcoholism on a public-health scale.
We now know that youth and adolescence are the critical window of
opportunity. The earlier one drinks in adolescence, the greater the
likelihood that he or she will develop alcoholism.
---------------------------------------------------------------------------
\1\ NIAAA National Epidemiologic Survey on Alcohol and Related
Conditions, 2003, and unpublished data from the Collaborative Studies
on the Genetics of Alcoholism.
---------------------------------------------------------------------------
The public-health implications of preventing alcoholism before it
becomes established in youth are large, given the magnitude of alcohol
misuse and its consequences. The 2002 report of the World Health
Organization ranks alcohol third as a preventable risk factor for
premature death in developed nations. Only tobacco and cholesterol are
greater risk factors.
In the United States, almost 18 million American adults met the
clinical diagnostic criteria for alcohol abuse or alcohol dependence in
2002.\2\ Annual costs to U.S. society of the consequences of alcohol
misuse are about $185 billion.\3\
---------------------------------------------------------------------------
\2\ Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC, Pickering
RP. The 12-month prevalence and trends in DSM-IV alcohol abuse and
dependence: United States, 1991-1992 and 2001-2002. Drug and Alcohol
Dependence, in press, 2004.
\3\ Harwood, H.; Fountain, D.; and Livermore, G. (2000). The
Economic Costs of Alcohol and Drug Abuse in the United States 1992
(updated for 1998). Report prepared for the National Institute on Drug
Abuse and the National Institute on Alcohol Abuse and Alcoholism,
National Institutes of Health, Department of Health and Human Services.
NIH Publication No. 98-4327. Rockville, MD: National Institutes of
Health.
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Heavy alcohol use in the American military is on the rise, with
more than 19 percent of male personnel and more than 5 percent of
female personnel reporting heavy use.\4\ (The Department of Defense
defined heavy drinking as five or more drinks on one occasion, at least
once a week, in its survey). This pattern of drinking is hazardous to
the health and welfare of the individual, the family, and society. In
the general population of the United States, alcohol-related illness
and injury account for at least 8 percent of all emergency-room
visits.\5\
---------------------------------------------------------------------------
\4\ The 2002 Department of Defense Survey of Health Related
Behaviors Among Military Personnel.
\5\ McDonald III AJ, Wang N, Camargo Jr CA. U.S. Emergency
Department Visits for Alcohol-Related Diseases and Injuries Between
1992 and 2000, Archives of Internal Medicine, 2004;164:531-537.
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ALCOHOL USE BY YOUTH
Alcohol is the primary psychoactive substance of abuse by American
children. As the NIAAA fiscal year 2005 Congressional Budget
Justification notes, 78 percent of 12th graders, 67 percent of 10th
graders, and 47 percent of 8th graders have used alcohol.
The same source of those statistics, the National Institute on Drug
Abuse's Monitoring the Future survey, also indicates that youth who
report having been drunk at least once include 62 percent of 12th
graders, 44 percent of 10th graders, and 21 percent of 8th graders.
Roughly half of those percentages say that they drank heavily five or
more drinks in a row in the past 2 weeks.
The NESARC data show that most cases of addiction, not only to
alcohol, but also to other drugs of abuse, first occur in youth, after
which new cases drop off sharply. The same research shows that, by
comparison, new cases of depression do not follow this trajectory,
instead continuing to rise after adulthood.
REFOCUSING THE RESEARCH
The new finding that youth is the stage of life during which
alcoholism is most likely to begin calls for a shift in the emphasis of
our research. By focusing even more strongly than we currently do on
developing strategies to prevent the onset of alcoholism in this
population, we have the potential to dramatically reduce, overall, the
occurrence of this common disease.
Likewise, shifting the focus of our medication development program
to the early stages of the disease stands to improve the effectiveness
of treatment. As with most diseases, early treatment for alcoholism
could prevent a host of problems, including the medical sequelae of
heavy alcohol use, which are estimated to cost $18.9 billion annually.
Studies show that a combination of factors underlie drinking
behaviors. Environmental factors--family and peers, for example--are
the dominating influences on whether or not an individual first uses
alcohol. Personality and temperament also influence the decision to
begin drinking. These factors have a profound effect on youth.
Whether or not drinking continues also is influenced by
differences, from individual to individual, in the pharmacological
effects (activities of genes, proteins, and metabolic products) that
come into play once drinking has begun. When drinking progresses to
alcoholism, alcohol's pharmacological effects will have become the
dominant influence on drinking behavior.
Identifying the pharmacological effects of alcohol is essential to
our ability to design effective prevention and treatment strategies for
youth. In childhood and adolescence, the pharmacological effects of
alcohol are occurring at a time of rapid structural and physiological
change in the brain. One of the major questions before us is how
alcohol's pharmacological effects work in ways that specifically
promote alcoholism during this vulnerable time of life. Two NIH Roadmap
initiatives will be particularly informative in this regard, as
follows.
The Roadmap Metabolomics Technology Development Initiative will
enhance our ability to identify metabolic processes that contribute to
alcohol dependence (and alcohol-related organ damage). People have
differences in the genes that regulate their cellular mechanisms,
including the enzymes responsible for alcohol metabolism. These
differences result in variations in how people respond to alcohol; for
example, the choice to drink and the amount of alcohol consumed.
Proteins, such as the receptors and transporters for
neurotransmitters, play roles in virtually every step of alcohol's
actions in the brain and other organs. Another Roadmap initiative, the
National Technology Centers for Networks and Pathways, will remove
barriers to defining how these proteins behave in the complex
biological systems in which they interact. Such proteins are potential
targets for medications, but efforts to alter the actions of proteins
with potential medication compounds have thus far met with limited
success in preventing and treating alcohol-use disorders in adults.
This Roadmap initiative will provide much-needed tools that will help
us track the interactions of specific proteins at specific points in
time and cellular space an ability that will enable us to develop more
precise targets for medications to treat the early stages of
alcoholism.
ACTIONS UNDERWAY
Our current research on drinking by youth includes studies of the
neurobiological mechanisms of adolescent alcohol abuse; an initiative
on preventing alcohol-related problems among college students; expanded
testing of preventive interventions, from rural children to children in
urban, diverse neighborhoods; and an initiative that is examining risk
factors and testing community-based, longitudinal prevention programs
among children in rural and small urban areas, in response to fiscal
year 2004 House Appropriations Report language.
Included in NIAAA's fiscal year 2005 Congressional Budget
Justification is an expansion of the latter initiative among youth in
rural and small urban communities, both of whom have high rates of
alcohol use. Both biological and environmental studies, as well as
studies of prevention strategies, will be included. The Substance Abuse
and Mental Health Services Administration, the National Institute on
Drug Abuse, the National Institute of Child Health and Human
Development, the National Institute of Mental Health, and other NIH
Institutes, as well as the Department of Education and other Federal
agencies, will be invited to collaborate in this initiative.
In addition to our research, we conduct outreach programs for
youth. The Leadership to Keep Children Alcohol-Free has recruited 33
Governors' spouses to spearhead a national prevention campaign. The
Task Force on College Drinking has brought together university
presidents and researchers, and is making headway in efforts to reduce
drinking by college students and in evaluating those efforts.
THE LARGER PICTURE
Alcohol abuse and alcoholism often result in behavioral outcomes
such as property damage, legal problems, disrupted family lives, and
derailed academic pursuits and professional careers. But its
consequences also include medical sequelae. With prolonged, heavy use,
it can act as a toxin, damaging virtually any organ in the body. For
example, alcohol is a leading cause of liver cirrhosis and contributes
to some kinds of cancer. Approximately 77 percent of the annual $185
billion cost of alcohol misuse is health-related, generated by medical
consequences and lost productivity associated with illness or death.
Research leading to effective strategies for preventing and
treating alcoholism early in life, when it is most likely to begin, can
help avert many other costly problems. While we will increase our
research on drinking by youth, we will continue our studies of the many
other facets of alcohol use, such as fetal alcohol syndrome, as well as
our research on the apparent protective effect of moderate drinking
against certain chronic diseases.
CONNECTION TO OBESITY
We will also conduct research on alcohol's role in the national
obesity epidemic. In addition to acting as a drug, alcohol is a food--a
highly caloric food. It has more calories per gram than do
carbohydrates or proteins.
In addition, alcohol acts on some of the same neurotransmitter
systems that regulate appetite. Some medications that work to reduce
appetite may also reduce alcohol intake. One of the highest priorities
that NIH lists in its Government Performance and Results Act goals is
human testing of the compound rimonabant for its potential to reduce
alcohol use.
Among the many neurotransmitter receptors that alcohol affects is
the one receptor to which the active ingredient in marijuana binds.
Stimulation of this receptor promotes appetite, and NIAAA animal
studies show that blocking the receptor with rimonabant has the
potential to reduce drinking in humans. NIAAA is preparing a human
trial of rimonabant for treatment of alcoholism. Rimonabant made news
in March of this year, when a French company announced the medication's
effectiveness in reducing both weight and smoking.
The anticonvulsant topiramate also is being tested for its
effectiveness in reducing both obesity and alcohol use, through actions
on another neurotransmitter system. The neurotransmitter gamma-
aminobutyric acid (GABA), among many others, is known to be an
important intermediary of alcohol's actions in the brain.
Obesity and alcohol are linked in yet another way, recent studies
show. The livers of obese rats undergo more cell death and sustain more
injury from heavy, periodic alcohol use than do those of their slimmer
counterparts. In humans, liver damage is one of the most prevalent
medical consequences of chronic drinking.\6\
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\6\ Carmiel-Haggai M, Cederbaum AI, Nieto N. Binge ethanol exposure
increases liver injury in obese rats. Gastroenterology, 125(6):1818-33.
Dec. 2003.
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IMPLICATIONS
On a large scale, epidemiology tells scientists where the action
is. That is the case with our new findings on the stage of life when
alcoholism is most likely to develop; that is, by age 25. We are
beginning to take steps to greatly increase our focus on this period--
on how variations in genetic, biological, and environmental factors
unfold to promote establishment of alcoholism during development.
Meanwhile, the NIH Roadmap initiatives on metabolomics and proteomics
are developing tools that can significantly accelerate our research.
______
Prepared Statement of Dr. Lawrence A. Tabak
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Dental and
Craniofacial Research (NIDCR) for fiscal year 2005. The fiscal year
2005 budget includes $394,080,000, an increase of $11,032,000 over the
fiscal year 2004 level of $383,048,000 comparable for transfers
proposed in the President's Request.
DELIVERING ON THE PROMISE OF BASIC RESEARCH
Although highly technical in nature, basic research provides the
detailed molecular clues that scientists and clinicians can use to
develop new strategies that more effectively prevent or treat disease.
This year, I would like to highlight how NIDCR's investment in the
basic sciences continues to yield important advances in oral and public
health. I also would like to mention how NIDCR stands to benefit from
the recently launched NIH Roadmap which has the potential to catalyze
virtually all areas of oral health research and, most importantly,
hasten the development of novel treatments that could greatly improve
American oral health.
GENE TRANSFER AND THE SALIVARY GLANDS
A prime example of basic research creating new clinical
opportunities is the transfer of replacement genes into the salivary
glands for therapeutic purposes. In the early 1990s, a team of NIDCR
scientists published their initial paper on the technical feasibility
of this approach. Thereafter, they began a unique long-term research
interest in transferring replacement genes into the salivary glands of
persons with Sjogren's syndrome and cancer patients whose salivary
glands were damaged during radiation treatment. The hope was that the
replacement genes would increase the production of saliva and eliminate
the chronic parched sensation that plagues people with dry mouth
conditions.
The NIDCR scientists also began to apply their gene transfer
studies to a third and seemingly less obvious therapeutic area: single-
protein disorders, such as type I diabetes, human growth hormone
deficiency, and erythropoietin-responsive deficiencies. Frequently
overlooked in the medical literature, salivary glands not only release
saliva into the mouth, they routinely secrete digestive enzymes and
other proteins into the circulatory system. As the scientists later
would demonstrate, the salivary glands readily accept gene-carrying
vehicles, or vectors. Thereafter, with minimal coaxing, the salivary
glands act as natural protein factories, dutifully manufacturing the
encoded replacement protein and pumping it at steady levels into the
circulation. The approach has some built in advantages over gene
therapy in other parts of the body, such as the liver. Salivary glands
are easily accessible and any potential adverse effects would be non-
life threatening. Moreover, salivary gland cells are encapsulated to
prevent leakage of the vector into the circulation and to other
tissues.
Recently, the group developed a new version of gene-carrying vector
that entered the salivary glands of mice and produced the human protein
erythropoietin for at least one year, a major step forward in the
research. Just as importantly, the vector--a stripped down,
bioengineered version of the harmless adeno-associated virus--did not
trigger a sustained immune response, a common setback in gene therapy
experiments.
Building on this strong basic research base, NIDCR has developed a
new initiative to evaluate the safety and efficacy of salivary gland
gene transfer techniques in people with systemic single-protein
deficiencies. The initiative will consist of three Phase I/II clinical
trials. The first clinical trial will involve a prototype systemic
single-protein deficiency disorder, adult growth hormone deficiency. As
currently proposed, 21 patients will be enrolled in the study, which
will be completed in four years. If successful, a second clinical trial
will be conducted to treat people with erythropoietin-responsive
deficiencies and ultimately a third clinical trial for those with
Sjogren's syndrome and/or cancer patients with dry mouth.
PERIODONTAL DISEASE AND PRETERM BIRTH
Another outstanding example of basic research creating new clinical
opportunities is in the area of preterm pregnancy. In the United
States, about one in eight babies is born prematurely,\1\ which is
defined as a birth that occurs three or more weeks earlier than the
expected due date. As all too many parents have tragically experienced,
extremely preterm babies can be so small and underdeveloped that they
must remain hospitalized for months and, if they survive, spend years
battling chronic health problems.
---------------------------------------------------------------------------
\1\ March of Dimes Defects Foundation. http://
peristats.modimes.org. Access on March 15, 2003.
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This serious and common problem has spurred scientists to identify
``risk factors'' associated with premature births. These risk factors--
which now include smoking, low-income status, hypertension, diabetes,
alcohol use, genitourinary tract infections--allow doctors to identify
women who are more likely to deliver prematurely and thereby tailor
their prenatal care to control or eliminate the risk factors.
However, the list of risk factors remains a work in progress. An
estimated one in four preterm births occur without any known
explanation, and that has left scientists searching for additional
susceptibility factors to help more mothers and reduce the estimated
$13.6 billion per year spent in the United States on hospital stays for
infants with a diagnosis of prematurity.\2\
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\2\ March of Dimes, PeriStats.
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In the mid 1980s, scientists began to suspect that periodontal
disease might be one of these elusive risk factors. These NIDCR
grantees and colleagues monitored women with more serious periodontal
disease and found they were more likely to deliver early than those
with mild or non-existent disease. They also have developed a plausible
biological explanation to explain the possible association. Based on
animal studies, the scientists hypothesized that certain bacteria from
severe periodontal infections, most notably Porphyroma gingivalis,
enter the bloodstream and eventually circulate to the womb. There, the
oral pathogens colonize and irritate the uterine wall. This causes
inflammation of the uterus and a rise in prostaglandins and other
infection-signaling chemicals, which can induce early contractions and
trigger premature labor.
Left unanswered is whether treating women for periodontal disease
during pregnancy will help them give birth to full term babies. The
NIDCR recently launched two large randomized clinical trials to answer
this important public health question. These national studies, which
merge the disciplines of dentistry and obstetrics, will involve over
2,600 women of various racial, ethnic, and economic backgrounds. What
is unique about these clinical trials is there will be a yes-or-no
outcome for each woman within 37 to 40 weeks, or the completion of the
pregnancy. Women will not need to be tracked at great expense for 10 or
20 years to get the final answer, as is often the case in clinical
research. Once all the data are compiled and analyzed, which could take
an estimated five years to assemble and analyze, researchers anticipate
that they will have sufficient clinical data to offer sound scientific
advice one way or the other on this critical public health issue.
PAIN RESEARCH
In another example of the potential payoff from basic research,
scientists are mapping in greater detail the multiple routes, or
pathways, that sensory signals travel en route to the spinal cord and
brain. This work has resulted in several new leads in how to more
effectively manage pain. One of the most promising new leads stems from
work conducted at the NIDCR. Our scientists found that an ultrapotent
compound selectively eliminated an entire class of pain-sensing neurons
from the peripheral nervous system of a living organism. The compound,
called resiniferatoxin (RTX), killed the neurons, blocking inflammatory
pain, thermal pain sensation, and reducing hypersensitivity to pain.
Importantly, the animals maintained their ability to sense pain, in
this case from a pinch, and they remained well coordinated, an
indication that RTX did not affect sensory nerves in the muscles and
joints. Since these initial reports, the investigators have assembled
additional preclinical data and are moving rapidly toward evaluating
RTX in human clinical trials.
In order to seed additional discoveries in pain research and to
help more Americans effectively manage pain, the NIDCR will begin an
initiative to define the proteins and protein networks involved in
processing pain-signal information in the orofacial region. This
initiative encourages interdisciplinary studies that employ genomic and
proteomic approaches, imaging technology, and computational biology to
clarify the molecular events involved in chronic orofacial pain
disorders.
PUTTING RESEARCH INTO PRACTICE
To achieve our goal of improved oral health for all people, NIDCR
must ensure that research advances are translated and adopted into
clinical practice. Many of the unique questions faced by dental health
professionals on a daily basis are most appropriately addressed in
dental practice settings, among unselected patient populations.
Practice-based research networks can generate important and timely
information to guide the delivery of health care and improve patient
outcomes. The NIDCR will launch an initiative to create dental
Practice-Based Research Networks (PBRNs) to conduct clinical research.
In time, linking the oral health practice-based research networks with
existing medical networks will provide additional patients,
professional expertise, and integration of resources for conducting
research across a broad spectrum of health care specialties. By
connecting practitioners with experienced clinical investigators, PBRNs
will enhance clinical research supported by the NIDCR and produce
findings that are immediately relevant to practitioners and their
patients. The networks can support a variety of clinical studies with
clear and easily defined outcome measures, and they typically draw on
the experience and insight of practicing clinicians to help identify
and frame the questions. Because research is conducted in the real-
world environment of dental practice, the results are more likely to be
readily adopted by practitioners.
NIH ROADMAP
The NIH Roadmap provides several additional opportunities to the
oral-health research community. For example the goals of the initiative
Building Blocks, Biological Pathways and Networks--are closely linked
to NIDCR's molecular anatomy efforts to identify the full complement of
genes, proteins and protein networks that are expressed in both oral
cancer and periodontal disease. Advances in proteomic analysis
platforms will be crucial for NIDCR to achieve its goal of defining the
salivary proteome--a critical step in the Institute's long-term goal to
exploit the salivary secretions for diagnostic purposes. The Molecular
Libraries and Molecular Imaging initiative holds great promise for
accelerating NIDCR's progress in defining the molecular pathways of
pain reception and in elucidating new therapeutic targets to manage
chronic pain. In addition, the initiative Research Teams of the Future
will enable NIDCR's ongoing inter- and multi-disciplinary efforts to
further expand and develop new ways to approach research questions.
Finally, the integration of dentists into the new clinical research
infrastructure that will be created by the Roadmap is key given that
overall health and oral health are interrelated and that certain
systemic conditions such as diabetes, Sjogren's syndrome, HIV/AIDS and
osteoporosis have important oral symptoms, manifestations or
complications.
NIDCR envisions a clear path ahead for oral and craniofacial
research. Many exciting new leads that have been reported in recent
years makes it easy to imagine that the next wave of research advances
will have a more profound and far reaching effect on oral health than
ever before.
Senator Specter. Thank you very much, Dr. Zerhouni.
We have been joined by two members of the Appropriations
Committee. Let me turn first to the distinguished chairman of
the full committee, Senator Stevens.
Senator Stevens. Well, Mr. Chairman, I am late. So I will
just ask to put my statement in the record. I do greet our
friends at the table and look forward to the comments and
questions.
Senator Specter. Without objection, the statement will be
made a part of the record.
[The statement follows:]
Prepared Statement of Senator Ted Stevens
Thank you Mr. Chairman. It's a pleasure to welcome Dr. Zerhouni and
his distinguished colleagues who head up the Institutes at NIH here
today.
I'd also like to thank Dr. Andy von Eschenbach. Andy, I understand
from my good friend Dr. Mike Phelps that you gave an excellent speech
this past Sunday to the Academy of Molecular Imaging meeting in
Orlando. As you know, PET and Molecular Imaging are special interests
of mine.
I must be brief since I have three other hearings where I must make
an appearance. However, I want to commend Dr. Zerhouni for his efforts
to develop the ``Roadmap'' initiative.
That initiative aims to focus NIH's resources on several broad
categories of medical research and to bring together different
disciplines to make real, rapid and visible progress to determine the
true basis of many diseases and then to treat them. The Roadmap, with
its focus in the Director's office is important because no single NIH
Institute can address these problems alone.
I'm particularly pleased that you have chosen to focus early
efforts of the Roadmap on the integration of nanotechnology, systems
biology, and molecular imaging. By combining these three disciplines we
hope to discover the molecular basis of diseases like cancers and then
to develop targeted molecular therapies to arrest the progress of the
disease and cure it.
In the fiscal year 2004 appropriations legislation I sponsored an
amendment to give the Director of NIH new authority to put together
innovative collaborative approaches to medical research to help speed
up the process. I hope that you, Dr. Zerhouni, will use that authority
to take bold and visionary steps to help us find these cures.
I've been a longtime supporter of large increases in funding for
medical research. I continue that support, but I must warn you that it
will be more and more difficult to sustain increases for medical
research unless you do pursue bold new approaches such as nanosystems
biology that have the potential to show real results that the American
taxpayer can see. We must begin to show a return on our investment in
order to continue it.
Once again, I commend Dr. Zerhouni and the directors of the NIH
Institutes for their leadership and efforts on behalf of all people.
Senator Specter. Senator Cochran, do you have an opening
statement?
OPENING STATEMENT OF SENATOR THAD COCHRAN
Senator Cochran. Mr. Chairman, thank you very much. I have
submitted a statement as well and hope it will be included in
the record.
I want to commend the Director and his associates who are
here today for the fine work that you are doing. I am
particularly impressed with the work in health disparities and
some of the research that is being undertaken now and funded by
the National Institutes of Health.
PREPARED STATEMENT
I notice an increase in the budget request for the National
Center for Minority Health and Health Disparities. I think that
is the entity that is supporting the Jackson Heart Study in my
State where very meaningful work is being done in conjunction
with the University of Mississippi Medical Center and Jackson
State University and other educational institutions in our
State to try to get at the bottom of some of the questions of
why there is such a disparity in some kinds of heart diseases.
This is being done in conjunction with the National Heart,
Lung, and Blood Institute as well. But I think the need for
more research, conducted in the places where we are
experiencing health disparities or high incidences of chronic
diseases, is something that is overdue, and I congratulate you
for taking this initiative.
[The statement follows:]
Prepared Statement of Senator Thad Cochran
Dr. Zerhouni, thank you for joining us today to discuss the budget
for the National Institutes of Health. We have had great success in
increasing NIH funding. It is my hope that we continue to support high
quality research, and focus this research on the most pressing health
issues of our country. Our goal should be to make sure NIH research
benefits all Americans.
I know you are familiar with the Jackson Heart Study, which looks
at the reasons why African-Americans suffer disproportionately from
heart disease. I hope the NIH will continue to take an active role in
making sure research like this reaches underserved areas of our
country. This relatively small investment has made a tremendous impact
on my state. I am encouraged by the progress made by institutes, like
the National Center for Minority Health and Health Disparities. I am
pleased to support NIH in these efforts.
Senator Specter. Thank you, Senator Cochran.
We will now proceed with 5-minute rounds of questioning, as
is the custom of the subcommittee.
FISCAL YEAR 2005 BUDGET REQUEST
Dr. Zerhouni, your proposed budget will permit grant
increases by only 1.3 percent instead of the inflationary
increase of 3.5 percent. If NIH applied its usual policy of
providing an average grant increase equal to the rate of
inflation, it is my understanding that about 640 fewer
competing grants would be funded than in 2004.
First of all, is that accurate?
Dr. Zerhouni. That is accurate, Senator.
Senator Specter. After the increases which we have provided
over the last 5 years, do you think the proposed budget is
sufficient to maintain the momentum and bring discoveries from
the laboratory to the doctor's office?
A subset of that is, how much additional funding would be
required to restore the usual NIH average cost policy, assuming
the same number of grants which are now in the budget?
Dr. Zerhouni. Ideally, Mr. Chairman, you would like to be
sure not to fall behind inflation. However, this year, because
of the very difficult budget environment, we had to make some
difficult choices. We elected to maintain the number of grants
to be able to provide as many scientists the opportunity to
succeed in applying and made some sacrifices on the cost
increases.
If we had $220 million more--the number is $220 million--we
could satisfy both conditions: have enough grants and
inflationary increases.
Senator Specter. If the Congress is willing to appropriate
the additional $1.3 billion, what new research initiatives
would NIH be able to conduct with these additional funds?
Dr. Zerhouni. As you know, because of the doubling and the
opportunities offered by the doubling, many of our institutes,
if not all of them, have opportunities in translation in
clinical research. This is the area of research generally that
is difficult to undertake in a budget that is the budget that
we are requesting.
So when you look at the priorities that we would have to
fulfill, if we had more resources, the first one would be to
keep up with inflation. The second would be to continue our
analysis and the framework for the Roadmap for medical
research, accelerate that. We have some programs like the
extramural construction programs, the IDeA program, that we
would like to enhance over time, including training stipends.
But the most important report from all the institutes is that
there are some clinical trials in translational research that
will have to be slowed down.
Senator Specter. Well, I would like to have a more detailed
answer for the record on what the impact will be on the
administration's request contrasted with what the impact would
be on an additional $1.3 billion. So we have specific
information as to how many grants there would be, what will
happen to the clinical programs.
Let me turn now to the issue of stem cell research. You and
I have discussed this at some length and the President made his
famous statement back on August 9th of 2001 about certain stem
cell lines being added. Some of those stem cell lines are
contaminated with mouse feeder cells. Some of those stem cell
lines are owned other places. We see Harvard with a $100
million allocation, which is wonderful but nothing compared to
the $28 billion you have. We see South Korea taking the lead.
We see scientists leaving the United States because ideology is
conflicting with medical research.
[The information follows:]
Research That NIH Could Fund With an Additional $1.3 Billion
The fiscal year 2005 President's Budget requests an additional $764
million for NIH, a significant increase to the program level given the
competing priorities within the Federal budget. An additional $1.3
billion over the request would provide $30.057 billion, an increase of
7.2 percent over fiscal year 2004. With this additional funding, NIH
would fund a larger share of the great research ideas that scientists
submit to us. We would be able to fund about 700 more research project
grants, increasing chances of a scientist's application being funded
and increasing the currently expected ``success rate'' from the 27
percent in the President's Budget to 29 percent. Additional priorities
would include:
--Accelerating implementation of Roadmap initiatives;
--Implementing an interdisciplinary approach to neuroscience research
by completing the phase 2 of the Porter Neurosciences Building;
--Providing average cost increases equal to biomedical inflation and
finance the committed levels for competing continuation grants;
--Increasing support for research training awards; and
--Increasing the amounts NIH pays on career awards.
Examples of the new research initiatives and significant expansions
of ongoing programs that NIH would conduct with these additional funds
follow:
transdisciplinary research on energetics and cancer (trec) (nci)
--Novel initiative involving scientists from multiple disciplines and
encompassing projects spanning the biology and genetics of
energy balance to behavioral, sociocultural, and environmental
influences upon nutrition, physical activity, weight, energy
balance and energetics.
--The TREC Centers would foster collaboration among transdisciplinary
teams of scientists with the goal of accelerating progress
towards reducing cancer incidence, morbidity and mortality
associated with obesity, low levels of physical activity and
poor diet.
--Centers would also provide training opportunities for new and
established scientists who can carry out integrative research
on energetics, energy balance and its consequences.
cancer biomedical informatics grid (cabig) (nci)
--Cancer research platform with common standards to expedite progress
by creating a network that links organizations, institutions,
and individuals to enable the sharing of cancer research
infrastructure, data, and tools.
--All cancer researchers would have access to a common research
infrastructure that creates a plethora of opportunities to not
only make important new findings but to do so more quickly and
efficiently than ever before.
--This new system would offer a library of tools and resources--from
clinical trial management systems to tissue bank and pathology
tools--that are all built to common standards and are
interoperable with other existing systems.
--Study population data would be far more robust and researchers will
be able to mine data in a way that simply isn't possible at the
moment.
--Joins the various fields of cancer research--from etiologic
research to prevention, early detection and treatment.
understudied cancers of high lethality (nci)
--A key element to the elimination of death from cancer by 2015 would
be to focus on malignancies which are highly fatal, such as
pancreatic, esophageal, and liver cancers.
--When these cancers are found, relatively little prolonging of life
or quality of life follows.
--Understanding gene-environment interactions is important in
learning who is at elevated risk, and how that risk is
regulated.
--Discoveries in these areas would lead to more accurate and cost-
effective public health interventions aimed at eliminating
mortality.
patient navigation research program: eliminating barriers to timely
delivery of cancer diagnosis and treatment services (nci)
--A major disconnect or gap exists between cancer Discovery and
Development research and Delivery for many Americans. Discovery
and Development research results in beneficial procedures for
cancer prevention, early detection, diagnosis, and treatment
that are intended for all Americans. Health disparities arise
when the Delivery system does not provide access to timely,
standard cancer care to everyone in the nation. NCI has
established the goal of eliminating suffering and death due to
cancer by 2015.
--The NCI is challenging principal investigators to develop effective
patient navigation interventions. These interventions would
address access barriers to quality, standard cancer care. The
purpose of the Patient Navigation Research Program (PNRP) would
be to develop interventions to reduce the time to delivery of
standard cancer care services after identifying a cancer-
related abnormal finding.
--The patient navigator could assist patients and their families
through the cancer care continuum.
--The research hypotheses are that navigated patients would: (1)
receive timelier, definitive diagnosis following screening and
abnormal finding; (2) receive more timely treatment following
positive diagnosis; (3) improve their satisfaction with the
health care system experience.
STUDY TO IDENTIFY RISK FACTORS FOR CORONARY HEART DISEASE (CHD) IN
HISPANIC POPULATIONS (NHLBI)
--The nation's largest minority group.
--Involve four community-based cohorts of adults, one each of
majority Cuban, Puerto Rican, Mexican American, and Central
American origin.
--Examine the role of acculturation in the development of risk
factors and determine if any play a uniquely harmful role in
the development of CHD in Hispanics.
--Include a closely integrated community and professional education
component to return the benefits of research results to the
participating communities.
FIVE-YEAR RANDOMIZED CLINICAL TRIAL OF CHRONIC OXYGEN USE IN MODERATE
TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PATIENTS (NHLBI)
--COPD is the fourth most common cause of death in the United States.
--Oxygen therapy is known to extend the life of patients with severe
COPD and hypoxemia.
--Billions of dollars are spent in the United States each year to
provide oxygen for patients with moderate or severe COPD
without good evidence as to who benefits.
--The trial would determine the effects of oxygen therapy on life
expectancy, hospitalization rates, independent living, and
quality of life.
MULTI-CENTER CLINICAL TRIAL TO EVALUATE NEW TREATMENT APPROACHES FOR
SARCOIDOSIS (NHLBI)
--Sacroidosis is a multisystem disease that usually affects the
lungs, and is more common in black Americans.
--Current treatment, which is based mainly on corticosteroids and
cytotoxic agents, is non-specific and has many dangerous side
effects.
--An NHLBI Sarcoidosis Research Working Group and several patient
advocacy groups recommended support for a trial to test new
agents for sarcoidosis.
IDENTIFY AND TEST APPROACHES TO REDUCING CARDIOVASCULAR DISEASE THAT
ARE SPECIFIC TO AMERICAN INDIAN AND ALASKA NATIVE POPULATIONS (NHLBI)
--Such an initiative would test approaches to reducing cardiovascular
disease (CVD) risk factors in American Indian/Alaska Native
(AI/AN) populations that can be incorporated into clinical
programs of community health care systems or delivered through
other public health approaches in native communities.
--Many AI/AN communities bear a heavy burden of CVD and modifiable
CVD risk factors.
--AI/AN communities are concerned that few intervention studies have
been launched to test possible solutions.
practice based research networks of dental specialists (nidcr)
--NIDCR's Practice Based Research Networks (PBRN) initiative would
otherwise be limited to networks of general dental
practitioners.
--Networks provide an infrastructure for conducting multiple,
collaborative clinical trials and observational studies
relating to dental practice and oral health care.
--Linkage of the oral health PBRNs with existing medical PBRNs would
provide additional patients, professional expertise, and
integration of resources for conducting clinical research
across a broad spectrum of health care specialties.
REGENERATIVE DENTAL MEDICINE (NIDCR)
--Diseases and injuries that damage orofacial tissues have a serious
impact on quality of life.
--Human stem cells would be utilized in combination with new bio-
inspired materials to regenerate the complex structures of the
orofacial system.
--Researchers would develop and test a number of stem cells and
biomaterial structures that mimic the multi-dimensional
architecture/function of tooth structures.
prospective studies on craniofacial pain & dysfunction (nidcr)
--Participants enrolled in this study would be followed over time to
identify risk factors associated with or predictive of the
onset of craniofacial pain and dysfunction.
--Temporomandibular joint (TMJ) dysfunction is a condition of
particular interest.
CLINICAL RESEARCH TRAINING (NIDCR)
--In the ``post-genomic era,'' translational and clinical research
plays an important role in bringing laboratory observations
into the clinical setting.
--NIDCR's new program announcement would foster clinical research
training in multidisciplinary research settings for all members
of the clinical research team.
FULL-SCALE CLINICAL TRIAL OF PRIMARY INTERVENTIONS TO PREVENT OR DELAY
TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS (NIDDK)
--Cases of type 2 diabetes are increasing in the pediatric
population, especially among adolescents and in certain
minority groups.
--A school-based intervention approach may be an effective way to
prevent risk factors for type 2 diabetes in children and
adolescents.
--Pilot studies for a multi-site, multi-component, school-based
intervention trial employing both environmental and behavioral
changes are under way; could launch the trial in fiscal year
2005.
IMPROVE CLINICAL TRIALS FOR TREATMENT OF INFLAMMATORY BOWEL DISEASE
(IBD) (NIDDK)
--The conduct of new clinical trials in IBD is hampered by the
current need to rely on indirect diagnostic tests and
nonspecific clinical features.
--The conduct of clinical trials and development of safer, more
effective treatments would be accelerated by research in
proteomics, to discover new biomarkers, and in molecular
imaging, to discover new non-invasive diagnostic imaging tests.
STUDY THE ROLE OF THE INTRAUTERINE AND POSTNATAL ENVIRONMENTS IN THE
DEVELOPMENT OF OBESITY (NIDDK)
--A better understanding of aspects of the intrauterine environment
and a mother's medical status that contribute to future
overweight and obesity in offspring could lead to more
effective interventions before, during, or shortly after
pregnancy.
--Strategies to prevent or treat obesity could also greatly benefit
from research on the impact of diet and other environmental
factors on the early development of brain pathways regulating
calorie intake and energy expenditure, and the permanence of
these effects in adulthood.
--Tools are available to conduct these studies in appropriate animal
models, including primates.
EXPAND FEASIBILITY TRIAL OF DAILY DIALYSIS TO DETERMINE EFFECTS OF NEW,
MORE INTENSIVE DIALYSIS MODALITIES ON MORTALITY AND CARDIOVASCULAR
DISEASE (NIDDK)
--Clinical studies are needed to determine whether life expectancy of
persons with end-stage renal disease (ESRD), or chronic kidney
failure, can be improved by modifying standard dialysis
regimens.
--Clinical centers have been established to test the feasibility of a
randomized clinical trial of more frequent dialysis.
--The current frequent dialysis trial is limited by size and design
to measuring intermediate outcomes, such as blood pressure,
anemia, and quality-of-life.
--An expansion of the trial could enable assessment of the effect(s)
of any change in dialysis regimen on hospitalization rate and
mortality, and on cardiovascular events--e.g., stroke,
myocardial infarction and heart failure--which often complicate
ESRD.
INITIATE THE VERY LARGE PHASE III CLINICAL TRIALS FOR PARKINSON'S
DISEASE (NINDS)
--Necessary to adequately test one or more of the neuroprotective
drugs for Parkinson's disease (minocycline, creatine, coenzyme
Q10 and GPI-1485) that are being tested in pilot trials.
CONDUCT A PHASE III CLINICAL TRIAL OF CEPHALOSPORIN FOR THE TREATMENT
OF ALS (LOU GEHRIG'S DISEASE) (NINDS)
--A screen of 1,040 drugs for potential use against neurodegenerative
diseases revealed one that may be particularly helpful for
ALS--the antibiotic cephalosporin.
LAUNCH CHEMICAL COUNTERTERRORISM RESEARCH TO COMBAT NERVE AGENTS
(NINDS)
--A number of chemical agents and toxins that have served or could
serve as terrorist weapons that target the nervous system.
--Research initiatives would focus on ameliorating the acute
neurologic responses to these chemical weapons as well as
alleviating any chronic neurodegenerative effects.
EXPAND THE SPECIALIZED PROGRAMS OF TRANSLATIONAL RESEARCH IN ACUTE
STROKE (SPOTRIAS) (NINDS)
--From four to eight centers.
--Would accelerate translation of basic research findings into
CLINICAL PRACTICE IN ACUTE ISCHEMIC AND HEMORRHAGIC STROKE.
INITIATIVE FOR PANDEMIC INFLUENZA (NIAID)
--Accelerate the development of next generation influenza antiviral
drugs and the production and clinical testing of up to four
pilot lots of candidate vaccines by up to one year or more.
--Influenza routinely causes 36,000 deaths per year in the United
States; however, the ability of flu viruses to occasionally
jump from animals to humans poses an imminent threat of a
pandemic affecting millions of people--over 20 million people
worldwide is estimated to have died during the flu pandemic of
1918.
--Research would also expand surveillance of emerging flu strains in
Asian animals to support development of new vaccines against
influenza strains with pandemic potential.
clinical trials of hiv/aids vaccine candidates (niaid)
--Expand clinical trials to accelerate by one or more years clinical
evaluation of six promising HIV vaccine candidates.
--Forty million people were estimated to have HIV/AIDS as of December
2003, with five million new infections occurring in 2003.
Another three million people died of the AIDS pandemic in 2003,
including 500,000 children, with a total of 70 million people
projected to die of the disease by 2020 if the current trends
continue.
--As with other pandemic infectious diseases, a key component to
preventing the spread of HIV/AIDS, and to mitigating the long-
range impact of the AIDS pandemic, is the development of an
effective HIV/AIDS vaccine. Critical challenges to developing
an effective vaccine include the need to clinically evaluate a
large number of promising HIV vaccine candidates in humans as
rapidly as possible to determine the toxicity and effectiveness
of the vaccine candidates. Factors contributing to the need to
clinically evaluate a large number of the most promising
vaccine candidates include the multitude of different HIV/AID
virus strains in existence and the frequency at which the virus
mutates and the fact that the virus infects and destroys the
immune system.
CLINICAL TRIALS IN ORGAN TRANSPLANTATION (NIAID)
--Expand and accelerate clinical trials to develop therapeutic
strategies to reduce the immune-mediated morbidity and
mortality of organ transplantation.
--Over 25,000 people receive organ transplants each year. Although
the one-year survival for single-organ transplantation has
improved over the last 15 years to a level approaching or
exceeding 90 percent, there has been little success in
reversing the decline in long-term graft-vs-host disease and
patient survival (13 percent to 55 percent at 10 years,
dependant upon organ).
--Studies would support both children and adults and will address the
barriers to short- and long-term success of transplant
procedures, including incompatibility between donor and
recipient, acute and chronic rejection, and complications of
long-term pharmacologic immune suppression.
clinical trials of topical microbicides (niaid)
--Expand existing support of clinical trials to accelerate the
clinical evaluation of four promising microbicide candidates
that have unique mechanisms of action to potentially protect
against sexually transmitted diseases (STD), including HIV/
AIDS.
--Topical microbicides are creams, gels or foams that can be applied
to the vagina or rectum and prevent STD-causing microbes,
including HIV, from invading the host. Pharmaceutical companies
have been reluctant to invest in research on microbicides
primarily because not enough data has been gathered through
large clinical studies in humans to provide a ``proof of
concept'' of any microbicide product.
--A partially effective microbicide could avert more than 2 million
HIV infections over a 3-year span; also, microbicides could
play a critical role in reducing STD transmission from mother
to infant during childbirth.
determine three-dimensional structures of proteins (nigms)
--Partner with other Institutes.
--Includes those related to cancer and emerging infectious diseases.
--Would be useful for the design of new antibiotics or anti-cancer
agents.
RESEARCH RELATED TO DETERMINING WHY DIFFERENT INDIVIDUALS RESPOND
DIFFERENTLY UPON TREATMENT WITH THE SAME DRUGS (NIGMS)
--Would help physicians customize treatment to individual patients
and may guide the development of new drugs that are more
predictively effective in most people.
DEVELOPMENT OF TOOLS FOR INVESTIGATING MODEL ORGANISMS (NIGMS)
--Model organisms such as fruit flies, mice, and roundworms have
provided great insights into fundamental biological mechanisms
and into human disease.
INNOVATIVE METHODS OF NEWBORN SCREENING (NICHD)
--While ensuring protection of privacy and providing ethical
safeguards, the NIH could proceed with efforts to identify, at
birth, hundreds of genetic defects associated with mental
retardation, primary immunodeficiency diseases, and other
potentially disabling and fatal conditions.
--Technologies generated by the Human Genome Project are available to
screen for hundreds of genetic diseases in newborns.
--A database in rare genetic diseases could be developed to enable
scientists to identify unrecognized genetic defects in
newborns, to study currently untreatable disorders, and to
develop new therapeutics.
--New screening techniques could allow clinical and preventive
interventions for currently treatable genetic disorders, such
as Severe Combined Immunodeficiency Disease (SCID), in time to
prevent or mitigate risks of early death or life-long
disability.
GENOMIC AND PROTEOMIC RESOURCES FOR PREMATURE BIRTH (NICHD)
--The NIH could establish a major consortium to create high-quality
data on human gene and protein expression, and to make this
information available on a publicly-accessible database that
will be dedicated to prematurity research. Investigators could
mine the database to advance their own research into the causes
of and ways to prevent premature birth.
--Premature birth causes almost 70 percent of neonatal deaths and
reducing prematurity would reduce wide racial disparities in
infant mortality.
--The depth and accessibility of the new genomic and proteomic
database could enable scientists to discover biomarkers for
premature birth and ultimately to develop early diagnostic and
effective treatment interventions.
RESEARCH BASE TO ASSESS EARLY CHILDHOOD LEARNING AND SCHOOL READINESS
(NICHD)
--The NIH could develop, refine, validate, and scale-up tests to
assess how well preschool programs help young children--
especially those at risk of school failure--to achieve ``school
readiness,'' cognitively, socially, and behaviorally.
--Significant academic, public, and political attention is focused on
the educational achievement of all children, beginning with
preschoolers, with certain federal funds tied to school
systems' performance.
--Preschool programs need scientifically-based tests to measure
accurately how well they prepare young children for later
school success. The programs especially need tests to measure
their performance with non-English speaking, ethnically
diverse, and educationally at-risk preschoolers. For the most
part, such tests do not exist, leaving preschool programs
unable to measure their performance for purposes of federal
funding.
--The NIH is the primary research agency with the basic and applied
scientific expertise to produce these tests, which are now
lacking.
THE NATIONAL CHILDREN'S STUDY (NICHD)
--The first two vanguard centers could be established for this
ground-breaking, congressionally-authorized, longitudinal study
of children's health and development. (There would be
significantly larger out-year costs.)
--Extensive planning and selected feasibility studies enable vanguard
centers, for this large and complex research effort, to
investigate how environmental factors, broadly defined, may
influence children's health and development.
--Primary care pediatric practices and other types of clinical sites
could become vanguard sites.
new interventions to improve pregnancy outcomes (nichd)
--The NIH could proceed with clinical trials and related studies to
prevent preterm births and improve neonatal outcomes.
--An NIH research network recently discovered the first effective
intervention--progesterone treatment of high-risk women during
pregnancy--to prevent recurrent preterm birth. The new
treatment cannot be approved by the FDA until researchers study
children of mothers who received the experimental treatment to
detect any later-emerging adverse effect in the children.
--A clinical trial is needed to affirm preliminary findings that a
nutritional supplement during pregnancy (an Omega-3 (n-3)
polyunsaturated fatty acid) is particularly efficacious in
preventing recurrent preterm birth in African American women,
for whom the experimental progesterone treatment was less
effective.
--A clinical trial is needed to affirm preliminary findings that a
single, simple injection of tin mesoporphyrin can successfully
prevent complications of hyperbilirubinemia that can result in
severe, life-long disabilities. If not diagnosed and treated,
hyperbilirubinemia can lead to jaundice, brain injury and
kernicterus (a condition of severe neural symptoms, associated
with high levels of bilirubin in the blood).
CLINICAL TRIAL FOR THE TREATMENT OF INFLAMMATORY EYE DISEASE (NEI)
--Would be able to begin a clinical trial to evaluate a treatment for
uveitis that will greatly enhance patients' quality of life.
--Uveitis is a group of ocular inflammatory disorders that represent
a major cause of vision loss and blindness in the United
States.
--This new monoclonal antibody therapy could mean fewer side effects
than current therapies that require systemic, immuno-
suppressive drugs, leading to an improved quality of life.
CLINICAL TRIALS NETWORK FOR THE TREATMENT OF AGE RELATED MACULAR
DEGENERATION (AMD) (NEI)
--Could launch a clinical trials network to test promising new
therapies for age-related macular degeneration.
--A clinical trials network is needed to test a variety of new
treatment approaches targeting the full range of disease forms
and levels of severity of age-related macular degeneration.
--Age-related macular degeneration is the leading cause of vision
loss among Americans over 65 years of age, the fastest growing
segment of the U.S. population.
ROBUST PROGRAM TO EVALUATE THE TOXICOLOGY OF NANOSCALE MATERIALS
(NIEHS)
--Nanoscale materials are already appearing in commerce as industrial
and consumer products and as novel drug delivery formulations.
Commercial applications and resultant opportunities for human
exposure may differ substantially for nanoscale vs. ``bulk''
materials.
--Currently there is very little research focus on the toxicology of
manufactured nanomaterials. There are indications in the
literature that manufactured nanomaterials may distribute in
the body in unpredictable ways and that certain nanoparticles
have been observed to preferentially accumulate in particular
organelles.
--The NTP/NIEHS research program would evaluate the toxicological
properties of major nanomaterials classes which represent a
cross-section of composition, size, surface coatings, and
physico-chemical properties, and use these as model systems to
investigate fundamental questions concerning if and how
nanomaterials can interact with biological systems.
USE OF METABOLOMICS TECHNOLOGIES FOR PREDICTING TOXICOLOGICAL RESPONSES
(NIEHS)
--Assessment of exposure and of risks from exposure could be greatly
improved by using metabolic indicators such as changes in gene,
protein or metabolite expression.
--Research supported by this initiative would focus on the
application of metabolomics technologies to identify predictive
markers of exposure, toxicity and disease in animal and human
populations; link metabolic profiles with biological pathways
and mechanisms of environmentally-related exposures and
diseases; and develop computational and modeling approaches for
assessment and integration of metabolomics data in predictive
toxicology research.
--This program would be a critically important application of the
basic methodology development work being undertaken as part of
the NIH Roadmap initiative on Metabolomics Technology
Development.
PREVENTION TRIALS TO ASSESS THE POTENTIAL ABILITY OF NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS AND A COMBINATION OF ANTI-OXIDANT VITAMINS
(NIA)
--Prevent Alzheimer's disease and age-associated cognitive decline.
development of a clinical trials consortium (nia)
--Test testosterone therapy for older men with low testosterone
levels who experience weakness, frailty, or a specific
disability that may be related to low testosterone.
NEW INTERVENTIONS FOR PREVENTION AND CONTROL OF HEART FAILURE IN
PERSONS AGED 65 AND OLDER (NIA)
--Fully develop and validate new interventions through clinical
trials.
MULTIDISCIPLINARY IMAGING RESEARCH PARTNERSHIPS FOR ADDRESSING
IMPORTANT BIOLOGICAL OR MEDICAL RESEARCH PROBLEMS OF SKELETAL MUSCLE
AND ASSOCIATED SOFT TISSUE (NIAMS)
--Improved imaging techniques provide a non-invasive way to monitor
changes in muscle (including muscular dystrophy and other
muscle diseases) and soft tissue.
--Multidisciplinary imaging research partnerships would stimulate the
development of novel imaging technologies that will help us
understand the genetic and molecular bases of musculoskeletal
soft tissue function, disease, and injury processes.
--Improved visualization of skeletal muscle and associated soft
tissue would enable researchers to more accurately measure
change during treatment or recovery from injury.
PURSUE THE RESEARCH NEEDS AND OPPORTUNITIES IDENTIFIED AT THE RECENT
NIH CONSENSUS DEVELOPMENT CONFERENCE ON TOTAL KNEE REPLACEMENT (NIAMS)
--Approximately 300,000 total knee replacements are performed each
year in the United States for end-stage arthritis of the knee
joint, and the rate of total knee replacement procedures
increases each year.
--While these replacements have shown outstanding success,
controversies still exist regarding implant designs and
treatment. Research studies suggest that there are particular
challenges that must be addressed in patients with Parkinson's
disease, rheumatoid arthritis, and diabetes mellitus, as well
as total knee replacements in younger patients.
INCREASE SUPPORT FOR TRANSLATIONAL RESEARCH--MAXIMIZING THE RESULTS OF
BASIC RESEARCH TO IMPROVE PUBLIC HEALTH (NIAMS)
--To enhance and expand translational research, a new centers program
is currently being or would be created called centers of
research translation.
--These centers would pair basic and clinical projects in
investigator-initiated and directed research that is centered
around particular diseases. Different diseases might require
different translation mechanisms and strategies.
--The goal of the centers is the application of powerful tools and
knowledge from basic research to clinical research to improve
human health.
ADDITIONAL STUDIES ON INNOVATIVE THERAPIES FOR RHEUMATIC AND SKIN
DISEASES (NIAMS)
--Would expand a successful program that the NIAMS instituted in
fiscal year 1999.
--Would solicit investigator-initiated proposals for clinical trials
of innovative therapies or approaches for the treatment of
rheumatic and skin disease.
--The previous program has produced a number of ongoing clinical
trials that form the cornerstone of NIAMS-funded trials in
rheumatic diseases.
--It is anticipated that the trials may identify new therapies for
rheumatic and skin diseases.
OTITIS MEDIA (NIDCD)
--Would initiate Phase One trials of vaccine candidates.
initiate a definitive epidemiological study (nidcd)
--Would establish the role of prenatal exposure to cytomegalovirus in
progressive hearing loss during childhood.
COMMUNICATION DISORDERS (NIDCD)
--Would expand research to identify the hereditary basis.
hair cell degeneration and regeneration in the inner ear (nidcd)
--Would initiate new research to define the molecular basis.
ENHANCE CAPACITY FOR DISASTER/TERRORISM MENTAL HEALTH RESEARCH (NIMH)
--Could enlarge this currently small program to establish emergency
research protocols in conjunction with local public health
authorities and develop critically needed measures for use in
emergency/disaster research studies.
RESEARCH INITIATIVE ON PEDIATRIC BRAIN-BEHAVIOR DEVELOPMENT VITAL TO
DIAGNOSING AND TREATING CHILD MENTAL DISORDERS (NIMH)
--This initiative would result in the first-ever identification of
neuroimaging markers of specific child mental disorders which
will lead to improved diagnostics and potential for new
treatments in pediatric mental illnesses.
USE NIMH CLINICAL TRIAL NETWORKS TO LAUNCH TRIALS ON SIMULTANEOUS USE
OF MULTIPLE PSYCHIATRIC MEDICATIONS FOR THE SEVERELY MENTALLY ILL
(NIMH)
--Multiple medications is a widespread practice, but there is limited
scientific data about its health effects and implications.
ANOREXIA AND BULIMIA (NIMH)
--Would expand research on understanding eating disorders.
more research using brain imaging techniques (nida)
--Would study how exposure to drugs of abuse can affect the
developing human brain.
--Understanding precisely how brain changes relate to behavior,
especially during childhood and adolescence, is critical to
designing effective strategies for reducing drug use in the
United States.
--Better treatment strategies targeting children and adolescents
would be developed through these efforts.
COLLABORATIONS OF ESTABLISHED CLINICAL TRIALS NETWORK (CTN) WITH OTHER
ESTABLISHED NETWORKS AT NIH (NIDA)
--NIDA CTN staff and staff from NCI's Community Clinical Oncology
Program have discussed the possibility of jointly supporting a
smoking cessation study. This study would bring these two NIH
clinical research networks together in a synergistic
collaboration and test the networks' interoperability.
--CTN has also had discussions with NICHD to link the CTN to a
Network at NICHD that is studying adolescents and comorbidity.
ENHANCE OUR UNDERSTANDING OF THE GENETIC OR HERITABLE RISK FACTORS
ASSOCIATED WITH DRUG ABUSE USING THE CTN AS A VALUABLE RESOURCE (NIDA)
--The CTN could serve as a resource to acquire genetic information on
participants in clinical trials and to better characterize
different phenotypes associated with addiction.
--As gene variants are identified in association with drug addiction,
research could be conducted to determine how this genetic
information can be used to tailor medications to an
individual's genetic needs. This knowledge could be
incorporated into ongoing medications trials in the CTN.
EXPAND RESEARCH ON PREVENTING DRINKING BY YOUTH IN RURAL/SMALL URBAN
AREAS (NIAAA)
--Note: Partnerships have been formed with academic health centers,
abbreviated ``AHC,'' to conduct this research. AHC have in
place the disciplines required, as well as extensive service
networks in rural and small urban regions.
--Would expand the number of AHC sites that would conduct the
research.
--Would collect data on psychological and physical development, and
environmental/community circumstances, that are not routinely
collected in medical settings. A variety of biomedical,
psychosocial, and environmental factors act in concert to lead
to adverse outcomes, such as alcohol-related problems. We must
understand what all of these factors are and how they interact,
if we are to make real advances in preventing and treating
adverse outcomes of alcohol use among youth.
EXPAND RESEARCH AIMED AT DEVELOPING MEDICATIONS FOR ALCOHOLISM (NIAAA)
--Would develop animal models of response to alcohol that closely
predict efficacy of compounds to be tested in humans.
--Would create a clinical-trials network for early Phase II human
trials. These trials could yield relatively quick results and
can indicate which compounds are worth the resources required
for IND approval and Phase III trials. Partnerships would be
sought with pharmaceutical companies interested in compounds
found to be successful in NIAAA early Phase II human trials.
EXPAND RESEARCH ON ALCOHOL METABOLISM (NIAAA)
--Alcohol metabolism plays a crucial role in alcohol dependence and
in alcohol-induced organ damage.
--Would form a bioinformatics data base, including data on gene
expression, proteomics, and metabolomics involved in alcohol
metabolism. This would be very important to our understanding
of which genes and proteins are involved in addictive behavior
and alcohol-induced organ damage, including cancer.
--In human clinical studies, use metabolomics and proteomics to
generate information on biomarkers of early/late tissue damage,
and identify targets for medication development.
--Using imaging technology, would determine if alcohol metabolism
occurs in the brain and, if so, determine what enzymes are
involved.
--Would identify all adducts (especially those that promote
autoimmune reactions) that result from alcohol metabolism, and
their roles in addictive behavior and organ damage.
--Would understand the interactions of alcohol metabolism with
comorbid conditions, such as obesity and diabetes.
TISSUE ENGINEERED HUMAN MODEL SYSTEMS (NIBIB)
--Would stimulate research and development in three-dimensional human
tissue model systems; engineered tissues for drug development;
and cell-based sensors for clinical diagnosis and treatment.
--Tissue engineering holds the promise to repair and/or replace
damaged organs.
--Tissue engineering strategies focusing on cell-based therapies, or
treatment modalities that rely on cells as the agents for the
treatment of diseases, have the potential to revolutionize
human therapeutics in the 21st century.
MINIMALLY-INVASIVE, IMAGE-GUIDED SURGERY (NIBIB)
--Would support research needed to rapidly develop computer-assisted,
image-guided microsurgery, which could replace traditional
surgery.
--Image-guided, minimally-invasive surgical procedures involve less
patient risk and pain and result in reduced hospital stays and
shorter recovery periods.
--Advances in surgical robots and microsurgical techniques could
enhance a surgeon's ability to perform complex tasks that
cannot be performed by hand.
--Could support: integration of existing technologies and development
of new technologies to navigate human anatomy, obtain
diagnostic tissues, localize and treat human disease and
injury, and monitor responses to surgical interventions.
chemistry of imaging agents and molecular probes (nibib)
--Could support exploratory projects for the synthesis, physical
characterization, and initial demonstration of feasibility for
clinical imaging agents for physiological, anatomical, and
molecular imaging.
--The ability to image molecular processes and cell function in vivo
provides an opportunity to understand biological processes as
they occur in their environment.
--Knowledge gained may be used to advance early-stage disease
detection and individually-tailored therapeutic interventions.
--The development of new clinical imaging agents requires focused
efforts by chemists and molecular biologists to discover new
compounds and materials suitable for in vivo imaging.
BRAIN-COMMUNICATION INTERFACE (NIBIB)
--Could develop technologies to create a more functional and
convenient system for restoring movement to paralyzed
individuals.
--Investigators have been successful in making Function Electrical
Stimulation (FES) a practical solution for restoring some
movement to paralyzed individuals.
--Current systems allow individuals with spinal cord injuries to
stand and breathe, and can restore functional hand grasp and
arm movement to some individuals with severe spinal cord
injuries.
--Recent developments in the technology of microelectrode design and
neurophysiological signal analysis open the possibility of
restoring greater control of motor function naturally--by
thinking about moving, a technique referred to as direct brain-
communication interface.
SUPPORT PLANNING GRANTS TO DEVELOP AND OPTIMIZE MODELS FOR DEPARTMENTS
OF CLINICAL RESEARCH WITHIN SCHOOLS OF MEDICINE (NCRR)
--Would provide tools to develop and test models.
RESTORE THE EXTRAMURAL RESEARCH FACILITIES IMPROVEMENT PROGRAM (RFIP)
FUNDS (NCRR)
--Would support construction and renovation projects at National
Primate Research Centers, animal research facilities and for
modem research laboratories at smaller institutions and
institutions within IDeA states.
ADDRESS THE SHORTAGE OF ADVANCED INSTRUMENTATION NEEDED TO PURSUE
CUTTING-EDGE BIOMEDICAL RESEARCH (NCRR)
--The High End Instrumentation program is the only NIH program that
provides support for research equipment that costs at least
$750,000; awards may be up to $2 million.
INTEGRATE TECHNOLOGY DEVELOPED THROUGH THE BIOMEDICAL INFORMATICS
RESEARCH NETWORK (BIRN) INTO CLINICAL RESEARCH AND OTHER NEW DOMAINS
OUTSIDE OF NEUROSCIENCE (NCRR)
--Some BIRN bioinformatics tools would be distributed and other tools
developed; hands-on workshops to inform investigators how to
use the tools for their research.
--Information technologies would be critical for scientific
discovery.
ncmhd could strengthen and expand its programs (ncmhd)
--Loan Repayment Program
--Centers of Excellence Program
--Research Endowment Program
NCMHD COULD FULLY LAUNCH ITS COMMUNITY-BASED RESEARCH PROGRAM (NCMHD)
--Would fulfill this Congressional requirement.
TRAUMA AND INJURY (FIC)
--Would initiate a new program to support research training to
address the growing global burden of morbidity and mortality
due to trauma and injury related to road traffic accidents,
suicide and drowning, mental health consequences of war and
civil disorders, lack of emergency care and blood products and
other related conditions.
--Training supported by the new program would lead to prevention
strategies and interventions in wound healing, development of
synthetic blood products, development of low-cost imaging
technologies, mental health strategies, and epidemiology to
assess risk factors as well as other activities to reduce the
impact of trauma and injury to individuals, families and
communities.
--Would support the establishment of a global network of highly
meritorious research training centers to mitigate the impact of
trauma and injury.
BRAIN DISORDERS IN THE DEVELOPING WORLD: RESEARCH ACROSS THE LIFESPAN
(FIC)
--This program was begun through short term planning grants in fiscal
year 2003 with the intention to grow to full research project
grants in fiscal year 2005.
--The program supports collaborative research and capacity building
projects on brain disorders throughout life relevant to low-
and middle-income nations. Brain disorders represent a fast
growing proportion of the global burden of disease.
DEVELOP THE NEXT GENERATION OF INTERNATIONAL RESEACHERS (FIC)
--It is imperative that the U.S. scientific community be prepared to
tackle new threats while at the same time be positioned to work
in partnership with colleagues around the world on shared
problems.
--Would increase support to train U.S. medical students, graduate
students and post-doctoral students in methodologies needed to
tackle global health challenges.
--Would extend and intensify efforts in resource-limited nations to
provide clinically appropriate, cost-effective, and sustainable
care of direct health and economic benefits for the global
community and mitigate the threat of disease crossing borders
to affect the U.S. population.
COULD SIGNIFICANTLY EXPAND CAPABILITY TO ANALYZE, ANNOTATE, AND
CLASSIFY MASSIVE AMOUNTS OF RAW SEQUENCE AND PROTEIN DATA TO MAKE IT
READILY USABLE BY RESEARCHERS (NLM)
--Molecular biology is generating an unprecedented amount of genomic
data that have the potential to overwhelm researchers by sheer
volume.
--The protein classification project provides a valuable method to
deduce the function of newly discovered proteins, greatly
accelerating research in the molecular basis of disease and
therapy.
--The unique and comprehensive Reference Sequence Collection would
assist in studying the function of single genes and performing
large-scale comparative analyses of genes across multiple
organisms.
COULD ACCELERATE PROGRESS TOWARD DEVELOPMENT AND IMPLEMENTATION OF
CLINICAL VOCABULARY STANDARDS THAT ARE CRITICAL TO RE-ENGINEERING THE
CLINICAL RESEARCH ENTERPRISE (NLM)
--The inability to share clinical data across systems impedes
clinical research and is responsible for a significant number
of medical errors.
--An interlocking set of clinical vocabulary standards must be
developed that incorporate robust mappings between multiple
vocabularies used in clinical research and health care.
--Research, testing, and demonstration projects would help to
determine best practices for incorporating vocabulary standards
into clinical research, health care, and public health.
COULD WORK WITH OTHERS TO DEVELOP COMMON SOFTWARE PLATFORMS FOR
ADVANCED CLINICAL AND EDUCATIONAL APPLICATIONS OF THE VISIBLE HUMAN AND
OTHER IMAGE DATA SETS (NLM)
--Investments in building a Visible Human Functional Atlas of the
Head and Neck and associated public software tools establish a
strong foundation for developing applications software,
including simulation and modeling, useful in medical training
and treatment.
--Further research and testing would fully integrate the data,
software, and other technology in the teaching of embryology
and anatomy courses.
DEVELOP AND SUPPORT WOMEN'S HEALTH INTERDISCIPLINARY RESEARCH CENTERS
ESPECIALLY IN THE AREAS OF: (OD--OFFICE OF RESEARCH ON WOMEN'S HEALTH)
--Pharmacogenetic research that focuses on sex differences in drug
metabolism and biological pathways involved in the treatment of
diseases such as cancer, cardiovascular disease to provide the
much needed information to improve clinical outcomes, including
a better understanding of the impact of pregnancy or depression
on pharmacokinetics, pharmacodynamics, drug efficacy and
adverse effects of therapeutic agents.
DEVELOP AND SUPPORT A CLINICAL TRIAL TO TEST A PROMISING INNOVATIVE
TECHNIQUE THAT COULD REDUCE THE SIZE OF UTERINE FIBROIDS (OD--OFFICE OF
RESEARCH ON WOMEN'S HEALTH)
--Could result in less morbidity for the women who face potential
surgery or infertility as a result of this condition.
LAUNCH A TRANS-NIH INITIATIVE TO LEARN WHETHER EHEALTH TECHNOLOGIES ARE
EFFECTIVE IN ENHANCING HEALTH BEHAVIOR CHANGE AND CHRONIC DISEASE
MANAGEMENT (OD--OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH)
--Consumers, patients and providers are increasingly using eHealth
applications for making health care decisions, and for
obtaining and dispensing services.
--These technologies offer a potentially low cost health delivery
system for underserved populations, as well as a means of
supporting provider adherence to evidence-based care.
Senator Specter. I want to finish this question before my
red light goes on to stay within the time limits. What is the
status and availability and adequacy of stem cell lines for
adequate stem cell research?
STEM CELL RESEARCH
Dr. Zerhouni. We have 17 cell lines now available. As you
know, we have worked aggressively in providing infrastructure
funding to all the sources that we knew were eligible for
Federal funding. NIH has done every effort to expand the
availability of lines. We have spent intramurally dollars to
create a characterization lab. We have gone from one laboratory
2 years ago to nine laboratories doing research. So we are also
realizing that training of scientists in these very difficult
methods is very important. So we are doing everything we can to
advance the field. So 17 lines are available to date, Senator.
Senator Specter. Well, I am going to violate the red light
for just one question. That is not enough, is it? Those are not
enough, are they? It is a leading question.
Are they?
Dr. Zerhouni. Well, we have a Stem Cell Task Force and Dr.
Battey really works very hard with the entire community to look
at what is the impact of what we need to do today of the number
of cell lines. The reports that we have is that we are learning
tremendously at a very high pace what are the advantages and
limitations. We are looking, for example, at these issues of
genetic stability and genetic diversity.
The Stem Cell Task Force at this point feels that we can do
a lot of research with what we have. Can we do all of the
research that will need to be done over the entire future of
stem cell research? No one can say that that would be the case.
Senator Specter. Well, I will pursue that with Dr. Battey.
I do not consider that an adequate answer, Dr. Zerhouni. It is
not often where I say your answer is not adequate, but I do not
believe that is an adequate answer.
We have been joined by the distinguished ranking member,
and I will yield to him at this time for 5 minutes for an
opening statement or questions or however he chooses to use his
time.
Senator Harkin. Mr. Chairman, thank you very much.
Senator Specter. We will have second rounds, but we have
Senator Stevens and Senator Cochran who are here.
STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Well, thank you very much, Mr. Chairman. I
apologize for being late. Some mornings you have to leave about
5:00 in the morning to get here because of the traffic.
It has been a privilege, Mr. Chairman, to work with you
over the last 14, almost 15 years, on behalf of supporting, as
you have said so many times, the crown jewel of our Federal
Government, which is the National Institutes of Health. I want
to thank you again for that working relationship, and I want to
thank you for your great leadership, Mr. Chairman, in doubling
the funding for NIH over that short period of time. It was a
pleasure to work with you to do that and to continue to work
with you on these crucial issues that impact the health and
welfare of all of our people.
Now, unfortunately, the budget we have submitted this year
is a far cry from the doubling years. I am concerned what it
means for the future health of NIH. We did not double the
funding for NIH to then fall off a cliff. But that is a real
possibility if we continue on with this kind of budget that we
have.
I want to welcome Dr. Zerhouni and the dozens of other NIH
leaders who have joined us. I do not always get the time to
hear from each of you, but I appreciate your being here and all
the work that you do.
All of you were involved in developing the NIH Roadmap. I
want to commend you for that effort. The initiative should help
break down the walls between the institutes and unite everybody
at NIH behind common goals. And, Dr. Zerhouni, I thank you for
your leadership in encouraging that and also for your
leadership in encouraging more risk-taking in the kind of
applications that NIH funds. We always have to be open to new
ideas. To the extent that I can, I hope to back you up. People
may say, well, why are you funding some of these far-out
things? Well, because sometimes we want to take a look at them.
And I really applaud you for doing that.
I just got here to hear a little bit about the stem cell
issue. We have discussed that many times before here. We know
that this research offers enormous potential to help ease the
suffering of people with Parkinson's and juvenile diabetes,
ALS, Alzheimer's.
I just had the occasion last evening to meet an old friend
of mine who I had not seen in several years. I found out that
he has Lou Gehrig's disease. It was just a startling thing for
me to see that last evening. His words to me were, you have got
to put more research into the stem cell research and find out
what is going on here. To see someone that you have known for a
long time and then you lost contact with him and then you see
him and you know they are not going to be around very much
longer and they are in middle stages of Lou Gehrig's disease,
it is a tough thing to see.
I am just concerned that the restrictive policies in this
research are delaying the day when these diseases could be
cured. Under the President's guidelines only those cell lines
generated before the arbitrary date of August 9, 2001 at 9
p.m.--not 9:30, not 8:45, but at 9 p.m., very arbitrary--can be
approved for federally approved research. The President said
then there were more than 60 eligible lines. Later we heard
there were 78. Now I just think I heard from you there were 17
that are available to researchers. Well, I will ask some
questions about this during my period of time.
These 17 were also grown on mouse feeder cells, all of
them, which raises questions whether or not they can ever be
used for any kind of human therapies.
Meanwhile, scientists in other countries are moving ahead,
but we cannot fund those. We cannot fund any of that kind of
research because those lines were developed after August 9,
2001 at 9 p.m. So again, I will get into that in my question
and answer period.
I thank you for letting me make my opening statement, and
whenever I can get a chance to ask questions, I will----
Senator Specter. Thank you, Senator Harkin. We will come
back to another round.
Senator Stevens.
Senator Stevens. Thank you very much.
Dr. Zerhouni, it is nice to see you here. I do not think we
have ever had an opportunity to put visuals on all of these
people that you have brought here with you today. So I want to
thank you for coming and apologize to them for taking their
time. I do not know of another group that is more important to
the future of our country than maybe now the intelligence
community might be that would have a similar impact in the long
range, but this long-range impact of you and your colleagues is
just staggering.
I heard the comments of my friend, Senator Harkin. Senator
Connie Mack came to me and urged me to support a concept of
doubling the NIH budget, and we have done that, Senator. So the
real question I think we have to do one of these days is
analyze what have we achieved with that money. I do think that
that is something that you and your assembled colleagues could
help us on. We are currently looking to increase other areas
now, the National Science Foundation for one and the
intelligence community for another. So the doubling of those
budgets in the next 5 years will take precedence I think
because of the circumstances that exist in the country.
PROSTATE CANCER
I am glad to see Dr. von Eschenbach here. My good friend,
Mike Phelps, reported you gave a tremendous speech at the
molecular imaging meeting in Orlando. Several of you know my
continuing interest in PET and its application to various areas
of your institutes. I do hope that we can be able to be very
aggressive in the use of that, the total molecular imaging
concepts, to Alzheimer's, which I believe is becoming a great
problem as the baby boom generation reaches retirement age.
But I have one specific question. Prostate cancer is also a
personal interest. I am a survivor now for 12 years. I would be
interested if Dr. von Eschenbach would comment upon finasteride
and what's going to happen to that clinical trial. I understand
the clinical trial was canceled and there were some problems.
Was the FDA a problem or was it that the high rate of tumor
growth in those taking the drug? What happened, Doctor?
Dr. von Eschenbach. Well, thank you, Senator, for that
important question because I think it really underscores and
points out not only the tremendous progress that we are making,
but also how the investment that you have been responsible for
in biomedical research is really now making it possible for us
to solve problems that before we did not even understand.
The issue with regard to the prevention trial of prostate
cancer using finasteride demonstrated that in fact the drug did
reduce the number of men who developed prostate cancer. So in
that regard, we stopped the trial because the endpoint had been
achieved. We in fact did get the answer and got the answer
earlier than we had hoped or anticipated and demonstrated the
protective effect of finasteride for a number of men who were
susceptible to prostate cancer.
What we also recognized in that trial was that although
fewer men developed prostate cancer on finasteride, the kind of
prostate cancer that they developed appeared to be more
virulent and more aggressive, and perhaps could even increase
their risk of progression or dying from prostate cancer.
So in addition to demonstrating the protective effect, what
we have now launched into is a subsequent set of studies to
understand the mechanisms of action and to determine the impact
on virulence. That is now an ongoing part of our research
investigation.
Senator Stevens. Thank you very much on that.
Mr. Chairman, I do have, unfortunately, on the schedule
several other subcommittees meeting. Again, I want to thank you
for bringing all of the directors of these institutes here. I
urge you to let them go quickly so they can go back to work.
Senator Specter. That concludes the hearing.
Senator Stevens. It concludes my time too. Thank you all
very much.
Senator Specter. Thank you very much, Senator Stevens.
I am going to step out for a moment down the hall to the
Judiciary Committee to see if I am needed for a quorum there. I
hope to return within the time allotted to Senator Cochran, but
if I do not, we will turn to Senator Harkin. Senator Cochran.
Senator Cochran. Mr. Chairman, thank you.
Dr. Zerhouni, we are very pleased with the fact that you
are exploring research possibilities in areas that have
previously been, I think, relegated to a fairly low priority.
Fundamental challenges such as understanding obesity, its
effect on health, what can be done to both treat those symptoms
and, more importantly, prevent that condition should be the
subject of research. I wonder what emphasis is placed in the
budget request with regard to research in this area.
OBESITY RESEARCH
Dr. Zerhouni. This is a very important topic to us.
Actually I would like to point out that NIH has been working on
obesity for over 10 years. I actually have a little graph here
that you could see whereby our investments started in 1996
because already at that time, NIH had predicted that the
obesity crisis will hit, and it became one of the top 10 topics
of research.
However, as you know, the rate of increase of obesity is
actually greater than what we expected, so we are increasing
our funding at the same level. In fiscal year 1996, we had $86
million. Next year we will have $440 million funding. Last year
I established a trans-NIH Obesity Task Force, led by Dr. Allen
Spiegel and Dr. Barbara Alving. They have come up with a new
strategic research plan for obesity, and despite the difficult
budget environment, we are going to increase our funding from
$400 million to $440 million in obesity research by $10
million. So we have almost quadrupled our investment in obesity
research while the rest of the NIH doubled to show you our
commitment to it and also our ability to see proactively where
research needs to be.
Senator Cochran. I hope you will take into account the
importance of concentrating some of this funding in areas that
suffer from this in a disproportionate way compared to the rest
of the country.
Dr. Zerhouni. Actually, Senator, this is one of the
priorities of the new plan. We are going to focus on childhood
obesity which affects rural areas and minority areas to a much
greater degree than other communities. So we will have an
implementation to be able to study that pattern early on in
life.
ROLE OF THE NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE
Senator Cochran. One new phenomenon I know is the fact that
millions of Americans are using dietary supplements and herbal
products today. The National Center for Complementary and
Alternative Medicine is playing a role in understanding the
efficacy and the effects of these products. What are your plans
for research with respect to these products?
Dr. Zerhouni. If you allow me, I would like Dr. Stephen
Straus, who is the Director of the National Center for
Complementary and Alternative Medicine, to answer that. He has
very definite plans and great strategies for that.
Dr. Straus. Thank you. Mr. Cochran, our goal is to
characterize the complementary and alternative medicine (CAM)
products that Americans are using, understand why they have the
activities they do, and then prove whether they are safe and
effective. We are doing this in a multi-tiered approach, much
of which is conducted in partnership with the other NIH
Institutes and Centers because of their strong areas of
thematic expertise.
We are doing this with products that are used for
neurodegeneration such as ginko biloba. In that regard, we have
already enrolled, in partnership with the National Institute of
Aging, the National Heart, Lung and Blood Institute and the
National Institute of Neurological Disorders and Stroke, over
3,000 patients in the largest study ever mounted of an herbal
product, and at that time the largest preventative study
conducted for dementia. The goal is to prevent the onset of
Alzheimer's disease in otherwise healthy, aging Americans.
At the same time we are studying mechanism, and in your own
State, we have funded outstanding investigators at the
University of Southern Mississippi who are showing us several
different chemical constituents in ginko that prevent the death
of neuronal cells in the brain. These are our strategies.
Senator Cochran. Thank you very much.
THE NATIONAL INSTITUTE FOR BIOMEDICAL IMAGING AND BIOENGINEERING
I appreciate also the NIH's recognition of the role for new
technologies in the detection and treatment of disease. The
National Institute for Biomedical Imaging and Bioengineering
was created specifically to enhance research in this area. Has
this investment begun to show results, Dr. Zerhouni?
Dr. Zerhouni. I think so. One of the most important
meetings that the institute has had was actually organized at
the University of Mississippi. It was a national strategic
meeting to try to see where the direction of the field would
go. Dr. Pettigrew is really a great leader and I would like him
to comment, if you do not mind, Senator.
Senator Cochran. Thank you.
Dr. Pettigrew. Thank you, Senator, and I appreciate having
the opportunity to respond to that question.
There are many problems that physicians alone cannot solve.
There are problems that also require the input of quantitative
scientists. These would be scientists, which include not only
imagers and physicists but also mathematicians and computer
scientists.
We have been very successful, I am pleased to report, in
bringing physicians and quantitative scientists together to
translate the fundamental discoveries from the technologically-
based scientists into meaningful clinical applications for
patients. That is certainly our goal and we work very hard to
achieve that.
The progress to date has been quite remarkable given our
short history of only 2 years. I would like to tell you about
two examples in this area.
NIBIB'S PROGRESS
The first is the development of a new technology called
quantum dots. These are small nano crystals that are able to
identify specific cells of interest in the body, for example,
cancer cells in lymphnodes. Quantum dots could also be used to
identify the deposition of plaque in arteries.
We have also seen progress in an area that many people in
the audience might appreciate. No doubt people here have had
MRI scans. This is a marvelous technology, in fact, the subject
of the Nobel Prize in Medicine this year. But some of our
researchers have tackled one of the problems, which is the
speed with which these scans can be made. These researchers
have improved the speed of acquisition of images 10-fold.
Studies that used to take several minutes to acquire can now be
acquired in a matter of seconds. The value of this is not only
in improved patient comfort, but also in opening up additional
applications such as image-guided surgery where speed would be
very important.
These are examples of some of the technological innovations
that we have been pursuing and have begun to bring to fruition
for the benefit of us all.
Senator Cochran [presiding]. Thank you. Thank you very
much, Mr. Chairman.
Senator Harkin, do you have questions?
Senator Harkin. If you want to have a follow-up.
Senator Cochran. No. Go ahead. I am trying to carry out the
chairman's 5-minute rule here. No, go ahead, please proceed.
Senator Harkin. Okay, thanks.
STEM CELL LINES
I would like to get back to the stem cell issue, if I
could, and I would like to direct some questions to Dr. Battey.
I believe you are heading the Stem Cell Task Force.
Dr. Battey. That is correct.
Senator Harkin. Correct me if I am wrong, but I think you
have said that under the best case scenario, only 23 lines will
be available to federally funded scientists. Is it 23 or is it
17? I am a little confused there.
Be that as it may, even if it is 23, my question basically
is will 23 be enough to realize the full potential of stem cell
research?
Dr. Battey. Let me begin by addressing the numbers issue
that you have raised.
The number 17 refers to the number of cell lines that are
available today for Federal funding that can be widely
disseminated across the research community, cells that--if you
had a laboratory--you could order and get in your laboratory
for experiments. There are six additional derivations located
at institutions that hold NIH infrastructure awards for the
purpose of developing such cell lines, expanding them, getting
them ready to be distributed, going from a derivation to a
useful cell line that can be distributed. And we are hopeful
that all six of these will become distribution quality cell
lines. When you add 17 and 6, one arrives at the figure 23.
Now, there are 31 derivations located in five institutions
in Korea, India, and Sweden that are eligible for Federal
funding that are on the registry, but they have not sought an
NIH infrastructure award to develop such cell lines. So we do
not know the status of these derivations. They are privately
held and we are not privy to that information.
Senator Harkin. Let me get to my question there, Dr.
Battey. Will 23 or 17 be enough to realize the full potential
of stem cell research?
Dr. Battey. I do not know the answer to that question, but
there are reasons to be concerned. For example, there was a
published paper in December showing that when some of the cell
lines, some of the 17, are grown in some people's hands and
passaged for prolong periods of time, they develop karyotypic
abnormalities, chromosomal abnormalities. These abnormalities
are some of the same abnormalities that are seen on occasion in
teratocarcinomas, which are tumors of cells like embryonic stem
cells. That is an issue of great concern and will need to be
followed very carefully.
While I have to say I do not know whether or not we will be
able to do everything possible with either 17 or 23 or 46 or 98
or 321 cell lines, I do know that if there is additional
functional diversity it is difficult to imagine that more cell
lines would be detrimental to research progress.
MOUSE FEEDER CELL LINES
Senator Harkin. Could any of these 23 lines ever be used in
human therapy since they have all been developed on mouse
feeder cells?
Dr. Battey. We have discussed this issue at great length
with the Food and Drug Administration, who would be the
organization overseeing the safety and efficacy of any clinical
studies that were done with these cells, were these cells to
ever be returned to patients in transplantation in an effort to
treat some of these awful disorders like ALS that you have
spoken about. When we talk to the FDA about this, they say that
the mouse feeder cell layer is an issue and the issue of
whether or not a retrovirus or some other bad thing might have
been transferred from the feeder cell layer to the human
embryonic stem cells is an issue that must be explored.
It is not, however, a prohibitive issue. It is one of many
issues, including the history of the cells, where they have
been cultured, what kind of medium they have been cultured in,
if there have been any serum or other biological additives,
what the state and purity of those are. So there is no question
the feeder cell layer is a safety issue, but it is one of many
safety issues and I do not think should necessarily be drawn
out of that context.
Would it be preferable to have cells that were not growing
on mouse feeder cell layers? I think the answer to that
question is yes. Would it be preferable to have cells that were
grown in a medium that had nothing but completely defined
substances, purified additives? Absolutely. That would be
better. In fact, the NIH is funding investigators to try to
develop better culture conditions for human embryonic stem
cells with the goal of ultimately moving the cell lines into an
environment that poses less questions about biological safety.
ACCESS TO ADDITIONAL LINES
Senator Harkin. The other question I had was basically
would federally funded scientists benefit from having access to
additional lines. I think you basically answered that.
Obviously, the more you have and the more involved, I would
assume the better the research would be. You would have just
more lines out there to look at.
Dr. Battey. We will understand much better what the
significance of number of cell lines is when we have explored
to a greater degree what we can do with the cells that are
available and widely distributed for Federal funding. But as I
said before, it is difficult to argue that a greater number
with more potential functional diversity would be detrimental
to the research effort.
Senator Harkin. If they had access to additional lines--
lead me on. I just want to get a better understanding. How
would this be not detrimental if they had more?
Dr. Battey. Well, the problem here and the reason why I
cannot be more specific in answering this question is that we
are just at the beginning of exploring what we can do with the
cell lines that are eligible for Federal funding. We are just
beginning to learn the master switches that keep these cells in
a pluripotent state and allow them to replicate indefinitely in
the laboratory. We are just beginning to get our hands around
the growth factors and gene expression profiles that are
associated with differentiation towards a cell type that might
be interesting for a therapeutic application such as a
dopamine-producing neuron that might be lost in a patient with
Parkinson's disease or a motor neuron that will be lost by your
friend with ALS. We are only beginning to understand, and until
we know more about what we can do with the cells we have, what
their limitations are, what their possibilities are, it is hard
for me as a scientist in a fact-based manner to give you a
better answer than the one I have given, as much as I would
like to do that.
STEM CELL POLICY
Senator Harkin. Is it time to reevaluate the policy that
has been in effect since August 2001?
Dr. Battey. I think it is very important for there to be a
continued dialogue between scientists, the National Institutes
of Health, your subcommittee, and the administration about what
the state of the science is. The decision to evaluate a
presidential policy is a decision that is made at the level of
the White House. Our role in this process, as I understand it,
is to provide facts and information for the people who make
policy, and we have a regular dialogue with individuals in the
administration, as well as individuals on some of your staff
about the state of the science in human embryonic stem cells.
Just on a personal note, I am happy to come and talk to anybody
who has questions or wants to know more about the state of the
science in what I consider to be one of the most exciting areas
of science for the future of biomedical research.
Senator Harkin. Thank you very much, Dr. Battey.
Senator Specter [presiding]. Thank you, Senator Harkin.
Dr. Battey, the Congress also has a constitutional role in
setting national policy and that starts with this subcommittee.
Dr. Zerhouni and Dr. Battey, as the area of responsibility may
fall, we would like to have a comprehensive report on what has
happened to the original 60-some stem cell lines announced by
the President back in August of 2001 and what has happened to
them, how many are in private hands, how many of them are
tainted with mouse feeders, how many of them can be used, what
is happening at Harvard, what is happening in South Korea, what
is happening in other countries so we can make an evaluation as
to what the policy ought to be.
[The information follows:]
Stem Cell Research
Question. What is the status of human embryonic stem cell (hESC)
derivations listed on the NIH Stem Cell Registry? How many are in
private hands? How many have been grown on mouse feeder layers? How
many are viable?
Answer. All of the derivations listed on the NIH Human Embryonic
Stem Cell Registry are privately owned by 15 different companies or
academic institutions. The providers indicated by an asterisk (*) below
are recipients of the NIH Infrastructure award to develop, characterize
and distribute cell lines.
BresaGen, Inc., Athens, Georgia*
4 derivations
3 lines available
The cells in derivation BG04/hESBGN-04 failed to expand into
undifferentiated cell cultures.
Cell & Gene Therapy Research Institute (Pochon CHA University), Seoul
Korea
2 derivations
0 lines available
Cellartis (formerly Cell Therapeutics Scandinavia), Goteborg, Sweden*
3 derivations
2 lines available
Cell line SA03/Salgrenska 3 was withdrawn by donor.
CyThera, Inc., San Diego, California*
9 derivations
0 lines available
The cells failed to expand into undifferentiated cell cultures.
ES Cell International, Melbourne, Australia*
6 derivations
6 lines available
Geron Corporation, Menlo Park, California
7 derivations, all duplicates of Wisconsin Alumni Research Fdn.
derivations
Goteborg University, Goteborg, Sweden*
16 derivations, reported to have not been exposed to mouse feeder
layers
0 lines available
Karolinska Institute, Stockholm, Sweden*
6 derivations
0 lines available
The cells failed to expand into undifferentiated cell cultures.
Maria Biotech Co. Ltd.--Maria Infertility Hospital Medical Institute,
Seoul, Korea
3 derivations
0 lines available
MizMedi Hospital--Seoul National University, Seoul, Korea*
1 derivation
1 line available
National Centre for Biological Science/Tata Institute of Fundamental
Research, Bangalore, India
3 derivations
0 lines available
Reliance Life Sciences, Mumbai, India
7 derivations
0 lines available
Technion-Israel Institute of Technology, Haifa, Israel*
4 derivations
2 lines available
University of California, San Francisco, California*
2 derivations
2 lines available
Wisconsin Alumni Research Foundation, Madison, Wisconsin*
5 derivations
5 lines available
Of the 78 entries on the Registry, 71 are from independent embryos
and 7 are duplicates located at both WiCell (Wisconsin Alumni Research
Fdn.) and Geron. The Geron cell lines are not being widely distributed
to the research community.
Of the 71 independent derivations:
--16 have failed to expand into self renewing, pluripotent cell lines
(9 at CyThera, 1 at BresaGen, 6 at Karolinska), and 1 line was
withdrawn by the donor at Cellartis (formerly Cell Therapeutics
Scandinavia, CTS). NIH provided Infrastructure support in
failed attempts to expand these 16 derivations into
distribution-quality cell lines.
--Of the remaining 54 independent derivations, 21 are available for
shipment, after expansion and characterization using NIH
Infrastructure grant awards. The 21 that are currently
available are:
BresaGen, Inc.--BG01, BG02, BG03
Cellartis--SA01, SA02
ES Cell International--ES01, ES02, ES03, ES04, ES05, ES06
MizMedi Hospital--MI01
Technion-Israel--TE03, TE06
UCSF--UC01, UC06
WiCell--WA01, WA07, WA09, WA13, WA14
--Of the remaining 33 independent derivations, 2 more are at
institutions with NIH Infrastructure awards. If these 2 were
developed into distribution quality cell lines ready for
shipment, there would be 23 independent cell lines available to
the research community. The 2 cell lines under development are:
Technion-Israel--TE04, TE07
--The remaining 31 independent derivations are all at institutions
located outside of the United States that have not applied for
NIH Infrastructure awards to develop their cell lines. Any
plans to develop these derivations into cell lines that are
available to the research community are unclear at this time.
The 31 derivations at institutions that do not have
Infrastructure awards are:
Pochon CHA (Korea)--2 derivations
Goteborg Univ. (Sweden)--16 derivations
Maria Biotech (Korea)--3 derivations
National Centre for Biological Sciences (India)--3 derivations
Reliance Life Sciences (India)--7 derivations
As far as we know, all derivations have been exposed to mouse
feeder cells, with the exception of the 16 derivations at Goteborg
University (Sweden).
Information on the detailed characteristics of each of the
derivations is available on the NIH Human Embryonic Stem Cell Registry,
http://escr.nih.gov.
Question. What is Happening at Harvard University?
Answer. On March 25, 2004, Harvard University announced the
derivation of 17 hESC lines in an article published in the New England
Journal of Medicine. Funding for the derivations and distribution of
these lines is being provided by the Howard Hughes Medical Institute,
Juvenile Diabetes Research Foundation and Harvard University.
On April 23, Harvard University announced the establishment of the
Harvard Stem Cell Institute. According to Harvard, the Institute will
encourage adult and embryonic stem cell research using both animal and
human stem cells. The Institute has two co-directors: Harvard Medical
School Professor David Scadden, who also directs Massachusetts General
Hospital's Center for Regenerative Medicine and Technology, and Douglas
Melton, the Thomas Dudley Cabot Professor of the Natural Sciences and a
Howard Hughes Medical Institute investigator.
Research at the Institute will be focused on five areas of disease
for which stem cell therapy seems most promising. The diseases all
result from some sort of organ or tissue failure and include: diabetes,
neurodegenerative diseases, blood diseases, immune diseases,
cardiovascular disease, and musculoskeletal diseases.
Although research on the 17 new human embryonic stem cell (hESC)
derivations are not eligible for Federal funding, NIH is currently
supporting several scientists at Harvard University whose hESC research
use lines eligible for Federal funding. Dr. Doug Melton is working to
identify the genes involved in hESC self-renewal and differentiation.
Dr. George Daley is studying hematopoietic development from hESCs. Dr.
Howard Green is working to develop the culture conditions to coax hESCs
to become the keratinocytes that make up human skin(s epidermis. Dr.
Jeffrey Harper is analyzing the signals that control hESC division.
Question. What is Happening in South Korea? What is Happening in
Other Countries?
Answer. On February 12, 2004, South Korean researchers published
the first scientifically credible report of the creation of a cloned
human embryo in the laboratory by means of somatic cell nuclear
transfer (SCNT) (Science 303: 1669-1674.) These scientists, supported
by the South Korean government, then used these cloned embryos to
establish a human embryonic stem cell line. They combined the DNA of a
woman's ovary cell with her donated egg, from which the nucleus had
been removed, and then stimulated the newly combined cell to divide.
The resulting very early embryo was then allowed to develop to the
blastocyst stage (five to nine days), at which point it was
disaggregated and the highly potent stem cells of the inner cell mass
were removed. These stem cells were then treated to produce a stem cell
line to be used for various kinds of biomedical research. Subsequent to
the publication of the SCNT study, the South Korean government voted to
ban the creation of cloned human embryos, but might allow cloning for
biomedical research on a case-by-case for medical treatment subject to
approval by a National Bioethics Advisory Commission. Scientists will
be permitted to use spare frozen embryos, left over from infertility
treatments and kept in laboratories for at least five years, for
limited stem cell research into treatments for hard-to-cure diseases.
The regulations banning human cloning are expected to come into effect
after President Roh Moo-hyun signs the bill. The regulations on stem
cell research will go into effect in 2005.
OTHER INTERNATIONAL STEM CELL EFFORTS
International Society for Stem Cell Research (ISSCR).--The
International Society for Stem Cell Research is an independent,
nonprofit organization established to promote and foster the exchange
and dissemination of information and ideas relating to stem cells, to
encourage the general field of research involving stem cells and to
promote professional and public education in all areas of stem cell
research and application. Opinions on the legitimacy of experiments
using human embryos vary among members of the European Union (EU)
according to the different ethical, philosophical and religious
principles in which they are grounded. EU member states have taken very
different positions on the regulation of human embryonic stem cell
research and cloning for biomedical research. More information about
the regulations and policies of EU members can be found on the website
of the ISSCR at the following link: http://www.isscr.org/scientists/
legislative.htm.
The International Stem Cell Forum (ISCF).--The ISCF was founded in
January 2003 to encourage international collaboration and funding
support for stem cell research, with the overall aim of promoting
global good practice and accelerating progress in this vitally
important area of biomedical science. The Forum's long-term aim is to
help stem cell scientists achieve a range of revolutionary medical
advances that will benefit people throughout the world. The ISCF is led
by the United Kingdom's Medical Research Council and consists of 14
leading supporters of stem cell research from around the world. Member
organizations are based in the United States, Finland, Australia,
Canada, Germany, France, Israel, Netherlands, Japan, Singapore, Sweden,
Switzerland, and the United Kingdom. Within ISCF, the United States is
represented by the NIH. The Juvenile Diabetes Research Foundation
International (JDRF) is also a member of the ISCF. One short term goal
of the ISCF is to compare different stem cell lines from the member
organizations. As part of this goal, NIH's federally approved stem cell
lines will be compared to those of other member organizations.
Information about the stem cell research efforts of the member
organizations can be found on the website: http://mrc.live.tmg.co.uk/.
Senator Specter I have discussed it with the President and
he has a view on it. The facts are very important in
formulating all of our views. So let us proceed to bring all
the facts to this subcommittee.
Dr. Zerhouni. You have my commitment to do so, Senator.
BIODEFENSE AGENTS
Senator Specter. Thank you very much.
On the issue of biodefense, the concerns about another
attack are with us imminently as we sit here. We have seen an
acceleration of the venom and hatred from Wahabes and Islam
fundamentalism and we have a long chronology of attacks going
back to 1983 when 283 Marines were killed in Lebanon, what
happened in Mogadishu, what happened in Africa in August 1998,
what happened with the Cole, what happened on 9/11. We have to
be prepared.
Dr. Fauci, you and I have discussed this on other
occasions. This year's request includes $1.7 billion toward
biodefense research activities. What are the principal
bioweapons that we are working to defend against?
Dr. Fauci. The principal bioterror agents that we are
involved in pursuing from the standpoint of developing
countermeasures remain the category A agents that we have
discussed before this committee on several occasions. High
among those are still smallpox, anthrax, botulism toxin,
tularemia plague, and the hemorrhagic fevers including Ebola.
We are pleased to report, as Dr. Zerhouni mentioned in his
opening statement, that over the past year with the resources
that this committee has generously given us, we have made
extraordinary progress in having available, either already in
the stockpile or in contract on its way either in phase I/II or
purchase, countermeasures in the form of vaccines for smallpox,
anthrax, and soon Ebola.
Senator Specter. If there was to be an attack on anthrax,
how well prepared are we?
Dr. Fauci. We are extraordinarily better prepared today
than we were in the anthrax attacks in the fall of 2001 with
the following issues. A, the stockpile of antibiotics right now
to treat prophylactically for the entire 60-day period with
ciprofloxacin or doxycycline is now able to meet a substantial
attack, God forbid that were to occur. And also, we are now
well into the development of the second generation of a
recombinant protective antigen anthrax vaccine that could be
used to vaccinate people who would go in to clean up, the
hazmat people, health workers, and those who would be required
to have an extended period of antibiotics. So the anthrax
situation is dramatically different than it was in this
building a year and a half, 2 years ago.
Senator Specter. Adequate?
Dr. Fauci. I believe adequate. I think we still have a ways
to go on every issue, but the progress that is being made
particularly in the arena of anthrax is striking.
Senator Specter. My red light is about to go on. So I would
like you to supplement in writing the details as to the other
threats, what we have done, whether it is adequate, and what
more needs to be done.
Dr. Fauci. I would be happy to do that.
Senator Specter. This is something we have to address
forcefully and promptly.
Dr. Fauci. Will do.
[The information follows:]
Research in Medical Countermeasures Against Category A Biological
Agents
The accompanying table provides a summary on the status of research
and development of medical countermeasures for Category A biological
agents. These biological agents and the countermeasures that are
currently available for them are identified in the first two columns.
Recent NIAID accomplishments are identified in column three (complete
details of these and additional accomplishments can be found in the
NIAID Biodefense Research Agenda for CDC Category A Agents Progress
Report).\1\ Candidate countermeasures that are at an advanced research
stage where rapid development of the countermeasures is scientifically
feasible are identified in the fourth column. Finally, many of the
countermeasures that are the focus of early research efforts are
identified in the last column.
---------------------------------------------------------------------------
\1\ See http://www2.niaid.nih.gov/Newsroom/Releases/
biodefensereport2003.htm for a detailed report on research progress
made to date for CDC Category A Agents.
---------------------------------------------------------------------------
I would like to add that we continue to support a national,
comprehensive biodefense research and development program. It includes
the development of other biodefense countermeasures to combat
Categories B and C biological agents, as well as a broad range of basic
research activities.
Senator Specter. Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
FUNDING OF RESEARCH GRANTS
Dr. Zerhouni, our staff has brought to our attention this
issue of the number of research grants that we are funding this
year. It is a question we always ask. What are we doing in
terms of the number of grants and the funding for these grants?
I have found--and you correct me if I am wrong on this--
that fiscal year 2004 marked the first time in 8 years that the
number of new competing grants went down. It dropped from
10,393 in fiscal year 2003 to 10,135 in fiscal year 2004. That
is the bad news. We might say, well, but the good news is the
President's 2005 budget calls for raising that number back to
the 2003 level of 10,393. So I said, okay. How do we do that?
As you know, when researchers get approved for NIH grants,
for the second, third, fourth years, there is an automatic 3
percent increase. Well, what I found out is that this
longstanding commitment by NIH to these researchers is
necessary so that they can pay their staff and give them their
annual salary increases or get new equipment and so forth in
the second, third, and fourth years. Now, that is 3 percent.
And this year's budget calls for an increase of 1.9 percent to
the second, third, and fourth year researchers. As a result,
the researchers will receive less money than what NIH committed
to providing them.
I am wondering about the effect this is going to have.
Could it force them to change the scope of their work in
midstream?
Now, again, I think that you and all of us are opposed to
breaking NIH's commitment to its grantees. Once you make a
commitment, you make a commitment. And I am concerned that this
budget is changing this policy, and I am wondering why are we
changing this policy. Why are we going to 1.9 percent rather
than 3 percent?
Dr. Zerhouni. These are very important questions and those
are the questions we have grappled with in a very difficult
budget environment and we had to make tough choices.
But let me address your first question which was that a
decrease between 2003 and 2004 and then recovery in 2005 in
numbers of grants. Fiscal year 2003 was the last year of the
doubling of the budget.
Senator Harkin. Right.
Dr. Zerhouni. We actually gave more grants in 2003 than we
planned to do so that is why the number in 2003 was higher. In
2004, we were planning on keeping that level or even go up a
little bit, but certain budgetary events occurred.
One, was the .59 percent cut across the board. That was in
conference.
Second was the reshifting of extramural construction, $119
million we had not requested. It was then put back into the
extramural construction.
Last but not least was what we call the planning and
evaluation tap, 2.2 percent of the NIH budget is used to fund
AHRQ, for example. So all of these elements decreased the funds
available for the grant pool in 2004.
Now we come to this year and we have a budget envelope of
2.6 percent. So we had to make tough choices.
I agree with your policy principle. This is something that
I have told all the Institute and center directors--that our
word is our bond. We should really commit to maintaining
research grants at least at an inflationary level so that they
do not lose the ability to purchase research, if you will.
SUCCESS RATES
But on the other hand, we also have a marked increase in
terms of applications and new scientists are coming to us
asking for grants. So we had to make a tough decision. I have
the information here to show you on the screen. If you looked
at our success rate at the beginning of the doubling, our
success rate was 32 percent here. The number of applications we
received in 2001 was 28,000. Senator, the number of
applications we are receiving is now 38,000. This year alone
our Center for Scientific Review will receive 66,000
applications for all types of grants for NIH as well as some
from CDC, AHRQ, FDA, and SAMHSA.
Senator Harkin. Excuse me, Dr. Zerhouni, but that 38,000
and the 37,000 and the 34,000 I see, are those the ones that
actually make it through the peer review process?
Dr. Zerhouni. Those are the ones that are applied for. They
are new and competing in that year. Only one-third of them will
get funded.
So, for example, if you go back to 2001, Senator, we had
28,000 grants. Thirty-two percent of those were funded. Then we
had 30,000 applicants. Thirty-one percent of those were funded.
And then in 2003, we had 34,700 applications.
So from my standpoint, as you look at the budget and you
look at the number of scientists out there who are coming up
with great ideas, we had to make a choice. Can we shave the
cost increases to allow more of these increasing numbers of
scientists to apply and be successful? So those are the
tensions, Senator, that I had to deal with in making the tough
decisions.
Senator Harkin. Well, I understand the dilemma you were
faced with. I guess under the budget we have got a choice,
either increase the number of new grants and cut back on the
increases for those that are already approved, or keep the
increases in and not have new grants.
Dr. Zerhouni. That's right.
Senator Harkin. That seems to be the dilemma.
Well, I do not know. Maybe we made the right decision, but
I just think we all ought to be aware, Mr. Chairman, of the
tradeoff that we have made with this budget. Now, I am
preaching to the choir here because this person right next to
me here keeps going on the floor trying to get our budget up
for NIH and I have backed him every time we have tried to do
that. But because of this budget, you have had to make almost a
devil's choice here in terms of the tradeoff. As you say, you
want to keep your word. You want to keep your commitment to
these researchers. But then the President's budget--it is his
budget--wants to have all these new starts, so then you have to
trade that off. I think that is why we need to actually get
this budget back up again so that that does not happen.
PROJECTING OUT-YEAR BUDGETS
Now, I am particularly concerned, as I said in my opening
statement, about the years ahead. According to OMB, NIH's
budget is expected to drop in actual dollars by 2 percent in
fiscal year 2006. If that goes through, do we have any idea
what that is going to mean in the number of grants and this
dilemma we are facing right now? What is that going to mean?
Dr. Zerhouni. At this point I heard the same thing that you
heard. So we queried and we asked are there decisions made in
our out-year budgets. To this moment, I am not told of any
formal decisions that were made by OMB that would imply those
cuts in the NIH budget.
Senator Harkin. I got it from OMB.
Dr. Zerhouni. I understand. There were projections, but
from the standpoint of our interactions with OMB, we are told
that those are projections and estimates that were made, not
policy decisions.
Senator Harkin. Well, I know they are projections. This is
what OMB is projecting. I have got the figures right here, a 2
percent cut in fiscal year 2006. That is next year. That is
what we are going to be confronting next year, and we are going
to be here next year.
So, again, I am just asking. We need some information. What
would this mean if OMB's projection goes through and we have
this 2 percent cut in fiscal year 2006 and we are confronting
that, what does it mean for grants, commitments to researchers,
size of grants? I mean, we need to know what the impact of that
is going to be.
Dr. Zerhouni. We definitely are willing to provide you with
those projections from the standpoint of the agency, and I will
provide that to you for the record.
Senator Harkin. I do not need them right now, but we are
going to need them sometime because we are going to start
getting into this sometime this year. But we should have some
handle on that as to what that might mean, so that we can at
least, as we have been saying here, get the facts out as to
what this would mean. Before the budget actually comes out is
what I am saying, we ought to have this out there so people
that are devising the budget know what it is going to mean.
Dr. Zerhouni. But again, we checked and those figures are
not decisional figures. They are not decisions made. They are
projections.
Senator Harkin. I understand that, but we have got to know
what those projections mean in real terms if in fact they
follow through on them.
Dr. Zerhouni. Definitely.
[The information follows:]
2 Percent Decrease in Fiscal Year 2006
As indicated, while there are mechanically calculated numbers in
the OMB computer system that reflect the Administration's overall
budget targets in the outyears, no specific funding decisions have been
made for NIH or most other domestic programs. In answer to your
question, if the NIH budget were to decrease by 2 percent in fiscal
year 2006 from the fiscal year 2005 Budget Request, the number of
competing research projects grants (RPGs) would decrease by an
estimated 2,000 to 2,500 depending on the average cost assumptions
used.
Senator Harkin. Thank you, Dr. Zerhouni. Thank you, Mr.
Chairman.
Senator Specter. Thank you, Senator Harkin.
OBESITY RESEARCH
Dr. Zerhouni, the issue of obesity is one of enormous
importance. In 15 years, obesity has increased by over 50
percent among adults; in 20 years, 100 percent among children
and adolescents. We would like a written response as to what
can be done by NIH, how this subcommittee might be effective on
diet or education. We have both Health and Human Services and
Education to try to confront this growing problem.
[The information follows:]
Obesity Research
The NIH Obesity Research Task Force, which was established in April
2003 to accelerate research on this escalating health problem, has
developed a Strategic Plan for NIH Obesity Research in broad
consultation with external scientific and lay experts. We believe that
implementation of this Plan is the best way that the NIH can contribute
to arresting the obesity epidemic. Combating obesity must be a broad
national effort to which the NIH can contribute new and important
scientific insights. As noted, the fiscal year 2005 President's Budget
request for the NIH reflects a 10 percent increase for obesity
research, which would bring total NIH funding for this area to $440
million. The proposed 10 percent increase includes additional new
funding to begin implementation of obesity research in specific areas
identified in the Strategic Plan because of their scientific
opportunity and public health challenge. With respect to your specific
reference to diet and education, the NIH has also recently created a
new obesity research website http://www.obesityresearch.nih.gov), which
contains links to science-based information generated by many of the
NIH Institutes and Centers for the public, patients, and providers. Two
helpful programs are the NIDDK's Weight Control Information Network and
the NHLBI's Obesity Education Initiative.
MEDICATION TO LOWER PLASMA LIPOPROTEIN (A) [LP(A)]
Senator Specter. Last year I asked Dr. Lenfant about
research on medication to lower Lp(a). Dr. Alving of the Heart,
Lung and Blood Institute, is there anything new that you can
inform the subcommittee about on the status of research toward
a medication to lower Lp(a)?
Dr. Alving. Yes. Thank you very much.
Since the past year, there has been no really new
information on Lp(a). It is still defined as an emerging risk
factor. But there has been certainly very new information on
the importance of lowering LDL, even below the guidelines of
less than 100 milligrams per deciliter.
Senator Specter. We see the LDL research all the time on
the front pages.
Dr. Alving. Yes.
Senator Specter. But how about Lp(a)? That has been
identified as a very problemsome factor. We have asked you
about it repeatedly. What efforts are you making to identify
what can be done about it?
Dr. Alving. The efforts to identify it have been in terms
of our ATP III Guidelines Committee, which has been reviewing
all of the literature and has been closely focused on the
latest guidelines and the latest research.
Senator Specter. Aside from reviewing literature, is there
active research being undertaken in the field?
Dr. Alving. There are R01 grants that include Lp(a), but it
has not really been able to be classified as a true risk
factor. But what I would like to do----
Senator Specter. How many grants?
Dr. Alving. What I would like to do is reply for the record
with an actual listing of the R01 grants so that I can give you
very specific information about all of our research.
Senator Specter. That would be fine. We would appreciate it
if you would specify the grants, what they are doing, what
their success has been, what more you need to do.
Dr. Alving. Yes. I will be happy to do that, Senator.
[The information follows:]
Research Activities on Lp(a)
The NHLBI supports a variety of grants and contracts related to the
cardiovascular disease (CVD) risks associated with elevated
concentrations of Lp(a), factors that influence Lp(a) levels,
mechanisms by which Lp(a) may affect CVD, and Lp(a) metabolism.
Beginning in 2005, the NHLBI will support measurement of Lp(a) in the
next four years of the National Health and Nutrition Examination
Survey.
The NHLBI supports the following R01 grants related to Lp(a):
--APEX: Adiposity Prevention by Exercise in Black Girls (Medical
College of Georgia).
--Biology of Proteolytic Derivatives of Lp(a) (University of
Chicago).
--Epidemiology of Coronary Artery Calcification (University of
Michigan at Ann Arbor).
--Genetic Determinants of Lp(a) Concentration (University of Texas
Southwestern Medical Center).
--Genetic Epidemiology of Blood Lipids and Obesity (University of
Pittsburgh).
--Lifestyle, Adiposity, and Cardiovascular Health in Youths (Medical
College of Georgia).
--Macronutrients and Cardiovascular Risk (Johns Hopkins).
--Regulation of Lp(a) Metabolism in Humans (University of California-
Davis).
The Institute also supports a K08 clinical investigator development
award for a project on Lp(a), Homocysteine, and Cardiovascular Risk in
End-Stage Renal Disease (Johns Hopkins).
Lp(a) is a subject in several epidemiologic studies supported
through NHLBI contracts:
--Atherosclerosis Risk in Communities Study (ARIC) (Baylor College of
Medicine, Johns Hopkins, Mississippi Medical Center, University
of Minnesota--Twin Cities, University of Texas Health Sciences
Center, University of North Carolina at Chapel Hill).
--Cardiovascular Health Study (CHS) (Johns Hopkins, University of
Washington, University of Vermont, University of Pittsburgh,
University of California--Davis, University of Wisconsin, Wake
Forest University).
--Coronary Artery Risk Development in Young Adults Study (CARDIA)
(Harbor-UCLA Research and Education Institute, Kaiser
Permanente Division of Research, Northwestern University,
University of Minnesota--Twin Cities, University of Alabama at
Birmingham, University of California--Irvine).
--Framingham Heart Study (Boston University Medical Center).
--Jackson Heart Study (Jackson State University, Mississippi Medical
Center, Tougaloo College).
Two NHLBI-supported cooperative agreements related to
cardiovascular disease risk factors in Alaska Natives and Native
Americans also include Lp(a) measurements:
--Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN)
(MedStar Research Institute).
--Strong Heart Study (MedStar Research Institute, Missouri Breaks
Research Inc., Southwest Foundation for Biomedical Research,
University of Oklahoma Health Sciences Center, Weill Medical
College of Cornell University).
In 1998, the NHLBI initiated a 4-year Lp(a) Standardization Program
to enable accurate and consistent measurement that may help to
reconcile various findings. Following completion of the program, a
workshop was held to present the new results, evaluate current
understanding of Lp(a) as a risk factor for CVD, and design future
studies. The workshop report was published in the journal Clinical
Chemistry in November 2003.
In summary, the following statements can be made with respect to
Lp(a).
--In general, research has found only a modest association between
Lp(a) levels and CVD risk.
--Compared with plasma LDL, Lp(a) concentrations are relatively
resistant to alteration by pharmacologic and lifestyle
interventions.
--Lp(a) is a complex and heterogeneous protein, and measurement
challenges have created difficulties in comparing data from
different sources or assessing the impact of findings on the
severity of disease.
--Measurement of Lp(a) is not currently recommended as part of CVD
risk assessment in patients.
Senator Specter. We are going to try to bring this hearing
to a close, following Senator Stevens' admonition. We are
keeping a lot of scientists away from their laboratories here
and there is a lot of work to be done.
SPINAL MUSCULAR ATROPHY
Dr. Landis, on the issue of spinal muscular atrophy
therapeutics, could you bring us up to date on when that will
be ready for clinical trials?
Dr. Landis. We are actually running three pilot clinical
trials right now based on previous data. This is a network that
is set up by Susan Iannaccone. In addition, the new project
looking at additional compounds is well underway. The advisory
committee has created a flow plan, and the first set of awards
to come up with an animal model that would be used for
preclinical studies will be awarded in the next week or 2.
In addition, two further solicitations have been put out,
one that would that would look for cell culture models again
being used to solicit better mechanisms to look at therapeutic
molecules, and the second to come up with a satisfactory way to
measure the protein that is missing. So I think, between what
pilot trials are ongoing and this new therapeutics initiative,
we are making significant progress.
Senator Specter. Would you supplement your answer with a
written report about how you project activities of NIH to
proceed in this line looking toward some ultimate answer?
Dr. Landis. I would absolutely be pleased to do so.
[The information follows:]
Spinal Muscular Atrophy
The NINDS has developed a new program, called the SMA Project, to
accelerate the development of therapies for this disease. The SMA
Project uses a performance-based, milestone driven, contract mechanism
to shorten the cycle time from recognition of a need or opportunity for
research to getting research underway on those issues and finding
answers. We awarded the primary contract in September 2003. This is an
extremely ambitious project in a very challenging area of medical
science, and scientific progress is not predictable. However, we have
explicitly designed the SMA Project to respond quickly to unanticipated
obstacles and to emerging opportunities, in the hopes of achieving our
goal of identifying a therapeutic candidate for SMA, and completing the
required preclinical research and development by late 2007.
One very important aspect of this program is that we are
coordinating the research centrally, calling for targeted research
projects to meet specific needs identified by an overall plan, and
carefully monitoring progress. The program is guided by a superb
Steering Committee, with scientists from academia, industry, the Food
and Drug Administration, and the intramural and extramural programs at
the NINDS. The Committee has already developed a plan and a sample
timeline showing all of the steps necessary to meet the goal of
bringing a candidate therapeutic to investigational new drug (IND)
status that is necessary for clinical trials, within four years. The
sample timeline and other detailed information about this program are
available to the public on a website at http://smaproject.org.
A crucial aspect of the SMA Project is the rapid turnaround from
identifying a research opportunity or need, to solicitation for
research proposals, to funding. The first targeted solicitation for
research subprojects, focused on mouse models for testing therapies,
was issued in December of 2003. These applications have been reviewed,
and expect awards to be issued by June 1, 2004. Two further
solicitations were issued in March, on cell culture models and on
measuring the crucial protein that is lacking in SMA. Full length
proposals are due in May, notification of subcontract awards is
scheduled for June and funding for July. These initial proposals have
been focused on generating the necessary research tools to identify a
candidate treatment that has the highest probability of success in the
clinic. Future solicitations will be aimed at stimulating new drug
identification; the development of gene therapy; and establishing
centralized testing facilities to conduct the activities required in
the flow plan, such as evaluating compounds in animal and cellular
models of SMA.
In addition to the contract-based SMA therapeutics development
project, we are currently supporting the short term, open label pilot
clinical trials, being conducted by Dr. Iannaccone, of three drugs that
have shown promise either in patients or in models of SMA. We will be
looking to see if these results warrant larger trials. We are also
planning a workshop on clinical trials for SMA to be held later this
year. This workshop is intended to ready the SMA clinical community to
test interventions that result from the SMA Project, by promoting
collaboration and high quality trial design. In preparation, we are
moving forward to work with the community on identifying and evaluating
drugs now available that may slow the progression of SMA and be ready
for testing in clinical trials.
So, we are exploiting the best existing opportunities in the short
term for slowing the disease, and at the same time we are developing
the best possible treatments for the future through the SMA Project.
Finally, I want to emphasize that the SMA Project is not replacing our
traditional investigator-initiated grant programs and our intramural
program on SMA; we are continuing to support this research as well. We
also have extensive research programs in cross-cutting areas such as
gene therapy, drug screening, and stem cells that may ultimately have
an impact on SMA.
Senator Specter. Thank you. Dr. Spiegel, in your field we
had a high visibility attention-getter when NBA basketball star
Alonzo Mourning was seeking a kidney transplant and was forced
to retire early on glomerular disease that damages filters in
the kidney that cleanse the blood. We were asked to hold a
separate hearing which was just too much to do. Could you give
us an update on where that stands?
Dr. Spiegel. Yes, Senator, I would be happy to do that.
The glomeruli are tiny units that cleanse the blood in the
kidney and they are comprised of kidney membranes and small
capillary blood vessels. There are really two types of injuries
that occur. One is glomerulonephritis, which is caused by the
immune system. Many institutes at NIH work together to direct
attention to preventing kidney failure from glomerulonephritis.
The form that you are referring to, focal segmental
glomerulosclerosis, affects children, and as you implied in the
case of Alonzo Mourning, can affect African Americans
disproportionately. We have intensive research efforts together
with patient advocacy groups such as the NephCure Foundation.
In fact, we have launched a clinical trial directed at new and
more effective therapies for this important disorder, and we
are hopeful that from that trial, new, safer, and more
effective medication will emerge. But at the same time, we are
also reinforcing our basic research to understand the basis for
the injury that occurs in glomerulosclerosis.
Senator Specter. Thank you very much.
AGE-RELATED MACULAR DEGENERATION (AMD)
Dr. Sieving, with respect to macular degeneration, how are
you moving ahead on the clinical trial networks for advancing
AMD research?
Dr. Sieving. AMD is a leading cause of vision loss and, in
fact, one of the leading causes of disability in the elderly.
It is a neurodegenerative disease. A part of the mission of the
institute is to form alliances, scientific alliances and
communication related to other neurodegenerations, including
Parkinson's and Alzheimer's disease, because there are some
common features that mutually these two multiple areas can
learn.
Now, the AMD network specifically is going to tackle the
opportunities presented by existing and new compounds to modify
the effects of and the course of AMD. One such opportunity--it
is not actually a network, but one recent success came from the
finding reported about a year ago that antioxidant nutrients
and zinc can decrease the risk of progressing to end-stage
vision loss. That is a very important finding in the aggregate
for the American population. Now it is our task to take that
bedside finding back to the bench to help understand on a
molecular and cell biological basis why this is happening.
Back on the AMD networks, we are proceeding with that.
Applications are coming in, will be reviewed, and we hope that
we will be able to successfully fund this venture.
AUTISM RESEARCH
Senator Specter. Dr. Insel, with respect to autism, could
you bring us up to date on the research activities of your
department and what success you have had and what your
projection is for the future?
Dr. Insel. I would be happy to, Senator.
We have in the past year launched a total of eight STAART
centers. These are interdisciplinary centers to bring both a
research effort and an intervention effort to autism. This is a
program that will go over the next 4 to 5 years. It involves
five of the institutes that are here today. It is, we think, a
great national effort that will, by coordinating efforts across
many different sites, lead to some very new insights into this
troubling and still very mysterious illness.
Senator Specter. We have quite a number of questions for
the record. We very much appreciate your coming. We appreciate
even more the outstanding work you are doing. We are committed
to doing our utmost to help you on the funding. When the other
research entities come forward with their requests, it
continues to be my view that it is a very, very solid capital
investment for the United States and we will continue to push
on all lines.
Anything further, Senator?
SPINAL MUSCULAR ATROPHY (SMA)
Senator Harkin. Yes, just one thing, Mr. Chairman.
Dr. Landis, on the SMA issue and what you are sending up to
us, I tried to listen to your answer, but would you also look
ahead as to how soon we might be going to clinical trials, and
what the--I hate to use the word ``Roadmap'' but what that time
line might be?
Dr. Landis. We would be pleased to do that. The projection
is 4 years for this new initiative to come to fruition with
optimally selected compounds, but I will certainly give you a
detailed answer.
Senator Harkin. I will take a look at that.
TRANS-NIH OBESITY TASK FORCE
Back on the issue of obesity, I met with Dr. Gerberding
last week at CDC. They have said that now it may be surpassing
tobacco usage as the biggest health menace that we face as
Americans. Again, I am wondering how, Dr. Zerhouni, you are
approaching this in terms of NIH's role in looking at obesity.
Again, it always seems to me that it is easier for people
who have never been obese to not be obese than it is for
someone who becomes obese to lose weight and hold it down. That
is just the facts.
So how do we prevent it in the first place? It seems to me
that one of the links in child health, Dr. Alexander, as kids
develop and as they learn and grow--it seems to me some
research ought to be done on that, what hkids eat and how they
develop. And there may be some genetic problems too. I do not
know. Dr. Collins could be involved in that.
I guess what I am getting at is this seems to lend itself
to some kind of an inter-institute kind of task force to look
at how we get to the prevention end of it, not just to the
cure, but what are some of the forces that might go into
preventing this in the first place.
Dr. Zerhouni. You are absolutely correct, Senator. As I
indicated to you in the past through this graph, NIH started
investing in obesity 10 years ago. But more importantly is the
relevancy of the question you are asking. Last year I asked
that we form a trans-NIH Obesity Task Force that is led by Dr.
Spiegel. This year we are going to increase funding in obesity
research by 10 percent. Here on the screen I can actually show
you what that 10 percent is going to be related to [see figure
3]: $3.5 million will be the prevention and treatment of
childhood obesity in primary care settings; $3.5 million will
be site-specific approaches to prevent and treat pediatric
obesity.
In a nutshell, we are going to focus on the aspects of
prevention and understanding the evidence that we need to, in
fact, stop the leading edge of the epidemic which is, we agree,
in childhood. The earlier we intervene, the more likely we are
to dampen the epidemic as we see it. So we are focusing those
efforts exactly on that. We are widening our portfolio. We have
quadrupled our investment on obesity research because we knew
already a while back that it would become a public health
problem.
In addition to that, the other part of the new plan, which
is on the web site, is receiving public comment, which is
related to exactly what you are asking, this trans-NIH view,
the other end of the spectrum is most of the diseases that are
developed because of obesity are what we call comorbidities,
diabetes, hypertension. Those are the ones that really hit the
patients hard. Those do not occur to the same degree at every
level of overweight. They occur disproportionately in the very
morbid, high obesity patient with a BMI index of 33, 34, 35. So
the other component of our strategy is to look at the front
end, children, and look at those who are very likely to develop
the co-morbidities and understand how you stop obesity from
giving diabetes to patients and what is the relationship there,
what is the relationship with hypertension, and so on.
Dr. Spiegel, who is leading the trans-NIH task force, will
be happy to provide you more detailed information. But we agree
with you. It is a multi-prong strategy that we need to
implement across all Federal Departments and NIH needs to
attack now the leading edge and the trailing edge of what we
know are the most important points of action that we should
take.
Senator Harkin. Well, I appreciate it. From my own
standpoint, it is the leading edge is where you ought to focus.
I hope what I am not hearing, Mr. Chairman, is that somehow or
other we are going to do research into finding out how you can
be obese, but we can have some kind of blockers to keep you
from getting diabetes. I think more research ought to be into
the front end to keep you from getting obese in the first
place. That is my unscientific statement on that.
Thank you.
Dr. Zerhouni. Thank you, Senator.
Senator Specter. Thank you, Senator Harkin. Thank you all
very much.
PREPARED STATEMENT RECEIVED
We have received the prepared statement of Senator Mary L.
Landrieu which will be placed in the record.
[The statement follows:]
Prepared Statement of Senator Mary L. Landrieu
Thank you, Mr. Chairman. Thank you, Dr. Zerhouni, for joining us
today to discuss the National Institutes of Health (NIH) and its 2005
budget, as proposed by the President. The National Institutes of Health
are an integral component to our nation's health and safety. Within the
twenty-seven Institutes and Centers at the National Institutes of
Health, research is being conducted and studies are beginning to show,
new and exciting ways to prevent, detect, diagnose, and treat the
diseases and disabilities which plague our country and the world.
Fostering communication and collaboration, the National Institutes of
Health provide grant and research opportunities to universities,
medical schools, hospitals, and other research institutes in addition
to conducting their own federal research. Through these collaborations,
the National Institutes of Health position themselves as the world's
foremost medical research center and the focal point for domestic
medical research.
The President's fiscal year 2005 budget request provides $28.8
billion for the National Institutes of Health. This number represents
an increase of $764 million, or 2.7 percent, over fiscal year 2004
levels. As a member of the Senate Appropriations Subcommittee on Labor,
Health, Human Services and Education, I was proud to lend my support to
doubling the National Institutes of Health budget in just five years.
By steadfastly keeping the National Institutes of Health funding on
track, my colleagues and I enabled the National Institutes of Health to
support far more promising research than it was ever able to before,
and to advance into new areas of science. While I am very proud of this
aggressive increase and commitment to funding, we must not fall back on
our commitment to medical research.
Research at the National Institutes of Health has a real and direct
impact on my state of Louisiana. The Centers for Disease Control and
Prevention (CDC) reports that 9,306 people have been affected by the
West Nile Virus in the United States this year. 240 of those infected
have died. Of those cases, the state of Louisiana has reported 123
cases and 8 deaths this year. Mosquito-borne diseases, such as the West
Nile Virus, represent one of the most serious and preventable public
health threats for many states. With the recent outbreak of the West
Nile Virus in the United States, the National Institute of Allergy and
Infectious Diseases at the National Institutes of Health have
accelerated their research efforts into the West Nile Virus, possible
vaccines, and treatment options. We have not yet developed a vaccine to
combat the West Nile Virus but with the proper funding, researchers at
NIH are committed to finding one.
In addition to West Nile, Louisianians also find themselves
battling another deadly epidemic, obesity. Currently in the United
States there are 127 million adults that are overweight, 60 million of
whom are obese, and 9 million who are severely obese. For children ages
6-11, 30.3 percent are overweight and 15.3 percent are obese. These
numbers have more than doubled in the last thirty years. This epidemic
threatens the health of our Nation and increases the incidence of type
2 diabetes, fatty liver disease, kidney failure, as well as many other
diseases. I am pleased to learn that the fiscal year 2005 budget for
the National Institutes of Health supports an expansion of $40 million
to its obesity research portfolio but this is not nearly enough to
reverse a trend of this magnitude. I hope that we can do more in the
near future to end this epidemic. It is imperative that we work to
understand the neurobiological, genetic, behavioral, and environmental
basis of obesity and develop strategies to maintain healthy weight in
adults and children.
In conclusion, I would like to speak briefly about the flu epidemic
that has recently taken a toll on our country and the global community.
The CDC estimates that 10-20 percent of Americans come down with the
flu each year. Of these numbers, more than 100,000 people are
hospitalized and approximately 36,000 Americans die from the flu and
its complications each year. While we have not experienced a flu
pandemic since 1968, each fall and winter brings with it a new strain
of the flu. Research institutions and health departments around the
world are cooperating to track flu outbreaks and to determine the many
different types, strains, and causes. The National Institute of Allergy
and Infectious Diseases (NIAID) at NIH currently supports research into
how the flu virus works and into developing better vaccines to prevent
and treat the infection. By supporting this research at NIH we can hope
to better track the development of flu strains and arm ourselves with
the proper vaccines and treatments that will prevent deadly outbreaks.
While these are but a few examples of the impact of NIH research on
the state of Louisiana, I think they make it clear that the research
being funded through the National Institutes of Health has a real and
immediate impact on the citizens of our country. By wisely investing in
medical research that advances the prevention and treatment of
diseases, we in fact are saving money that would otherwise have to be
used to diagnose and treat these diseases. I know that my colleagues
agree that funding a cure is perhaps the best use of government
resources there is. It is my hope that we will continue to increase the
National Institutes of Health budget so that our children and
grandchildren can truly benefit from the cures and medical advances
made every day at NIH.
ADDITIONAL COMMITTEE QUESTIONS
Senator Specter. There will be some additional questions
which will be submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Herb Kohl
OBESITY
Question. Dr. Crawford, both USDA and FDA have recently announced
new efforts to combat the increasing problem of obesity. FDA announced
the ``Calories Count'' program, and USDA has money in several programs,
including WIC, to help battle this problem. However, for all of the
government's efforts, all of the money being put into this effort pales
in comparison to the food industry's billions of dollars worth of
advertising. How can the government successfully get its message out
when, at first glance, its efforts appear to be dwarfed by the food
industry? How do your agencies compete with that?
Answer. In support of the President's Healthier U.S. initiative,
the DHHS established a complementary initiative, Steps to a Healthier
U.S., which emphasizes personal responsibility for the choices
Americans make for healthy behaviors. One aspect of this initiative
focuses on reducing the major health burden created by obesity and
other chronic diseases. Following DHHS' July 2003 Roundtable on Obesity
and Nutrition, on August 11, 2003, FDA established an Obesity Working
Group, or OWG, to prepare a report that outlines an action plan to
cover critical dimensions of the obesity problem from FDA's perspective
and authorities. This report was released on March 12, 2004.
There is no simple answer to the problem of obesity. Achieving
success in reducing and avoiding obesity will occur only as a result of
efforts over time by individuals as well as various sectors of our
society. It should be noted, however, that most associations, agencies,
and organizations believe that diet and physical activity should be
addressed together in the fight against overweight and obesity.
The OWG report provides a range of short and long-term
recommendations to address the obesity epidemic with a focus on a
``calories count'' emphasis for FDA actions. These recommendations are
based on sound science and address multiple facets of the obesity
problem under FDA's purview, including developing appropriate and
effective consumer messages to aid consumers in making wiser dietary
choices; establishing educational strategies and partnerships to
support appropriate messages and teach people, particularly children,
how to lead healthier lives through better nutrition; developing
initiatives to improve the labeling of packaged foods with respect to
caloric and other nutrition information; encouraging and enlisting
restaurants in efforts to combat obesity and provide nutrition
information to consumers, including information on calories, at the
point-of-sale; developing new therapeutics for the treatment of
obesity; designing and conducting effective research in the fight
against obesity; and continuing to involve stakeholders in the process.
Regarding food labeling, the OWG report contains several
recommendations based on sound science. I will provide these
recommendations for the record.
[The information follows:]
Publish an advance notice of proposed rulemaking, or ANPRM, to seek
comment on the following:
--How to give more prominence to calories on the food label, for
example, increasing the font size for calories, including a
column in the Nutrition Facts panel of food labels for percent
Daily Value for total calories, and eliminating the listing for
calories from fat;
--Whether to authorize health claims on certain foods that meet FDA's
definition of ``reduced'' or ``low'' calorie. An example of a
health claim for a ``reduced'' or ``low'' calorie food might
be: ``Diets low in calories may reduce the risk of obesity,
which is associated with type 2 diabetes, heart disease, and
certain cancers.''
--Whether to require additional columns on the Nutrition Facts panel
to list quantitative amounts and percent Daily Value of an
entire package on those products and package sizes that can
reasonably be consumed at one eating occasion--or declare
quantitative amounts and percent Daily Value of the whole
package as a single serving if it can reasonably be consumed at
a single eating occasion; and,
--Which, if any, reference amounts customarily consumed of food
categories appear to have changed the most over the past decade
and hence require updating.
In addition, FDA will file and respond in a timely way to petitions
the agency has received that ask FDA to define terms such as ``low,''
``reduced,'' and ``free'' carbohydrate; and provide guidance for the
use of the term ``net'' in relation to carbohydrate content of food--
these petitions were filed on March 11, 2004.
FDA will also encourage manufacturers to use dietary guidance
statements, an example of which would be, ``To manage your weight,
balance the calories you eat with your physical activity.'' In
addition, the Agency will encourage manufacturers to take advantage of
the flexibility in current regulations on serving sizes to label as a
single-serving those food packages where the entire contents of the
package can reasonably be consumed at a single eating occasion and
encourage manufacturers to use appropriate comparative labeling
statements that make it easier for consumers to make healthy
substitutions.
FDA believes that if the report's recommendations are implemented
they will make a worthy contribution to confronting the nation's
obesity epidemic and helping consumers' lead healthier lives through
better nutrition.
FDA also believes that the regulatory scheme for claims in food
labeling, whether health claims, nutrient content claims, or other
types of claims, are science based, and we continue to consider
modifications to our regulations to keep up with recent scientific
developments. A benefit of standardized, science-based terminology, as
with other terms that FDA has defined that consumers may use to make
health-based dietary choices--e.g., terminology concerning fat
content--is that it allows consumers to compare across products and it
encourages manufacturers to compete based on the nutritional value of
the food. However, FDA does not regulate television and other media
marketing of food products. Some of the modifications FDA is currently
considering are described above in the list of topics to be covered by
the ANPRM the agency intends to issue.
With respect to conveying the report's messages to the public, FDA
believes that all parties, including the packaged food industry,
restaurants, academia, and other private and public sector
organizations in addition to government agencies at all levels, have an
essential role to play. On April 22, 2004, FDA's Science Board focused
on specific recommendations from the OWG report. These recommendations
call on FDA to work through a third-party facilitator to engage all
involved stakeholders in a dialogue on how best to construct and convey
obesity messages in the restaurant setting and in the area of pediatric
obesity education.
This approach is one example of how the Agency intends, by means of
public and private partnerships, to leverage its ability to convey
appropriate messages on obesity to the public with the goal of changing
behavior and ultimately reversing obesity trends in the United States.
IMPORT INSPECTIONS
Question. Dr. Crawford, the FDA budget this year includes a $7
million increase to fund 97,000 food import examinations. This is a big
increase in inspections over any previous year--still, however, less
than one percent of all of the food imported into this country will be
inspected. How would you respond to charges that you still aren't
inspecting nearly enough imported food, especially in light of events
during the past year where bad food has gotten in and people have died?
How do we ensure consumers that their food is indeed safe?
Answer. FDA is appreciative of the additional funding we have
received for the inspection of domestic firms and for inspections of
imported foods. FDA believes it is more effective to focus our
resources in a risk-based manner than to focus simply on increasing the
percentage of imported food shipments that are physically inspected. It
is important to note that every shipment of FDA-regulated food which is
entered through Customs and Border Protection as a consumption entry is
electronically reviewed by FDA's Operational and Administrative System
for Import Support to determine if it meets identified criteria for
further evaluation by FDA reviewers and physical examination and/or
sampling and analysis or refusal. This electronic screening allows FDA
to concentrate its limited inspection resources on high-risk shipments
while allowing low-risk shipments to proceed into commerce.
Due to constantly changing environments of operation, e.g.,
counterterrorism and BSE, our domestic inspection and import strategy
cannot be defined in terms of a percentage of coverage through
inspections, physical examinations and sample analyses. It needs to be
a flexible blend of the use of people, technology, information and
partnerships to help protect Americans from unsafe imported products.
Accordingly, the Agency is developing and using strategies for
mitigating risks prior to importation through partnerships and
initiatives based on best practices and other science based factors
relevant to the import life cycle, i.e., from foreign manufacturer to
the U.S. consumer. Recently this principle has been applied in the
``Canadian Facility Voluntary Best Management Practices for Expediting
Shipments of Canadian Grains, Oilseeds and Products to the United
States'' implemented February 24, 2004, and designed to mitigate the
potential of mammalian protein prohibited from being fed to cattle or
other ruminants under BSE-prevention regulations promulgated by CFIA
and FDA.
Another piece of the long term solution to a higher level of
confidence in the security and safety of food products lies in
information technology that will merge information on products and
producers with intelligence on anticipated risks to target products for
physical and laboratory examination or refusal. This strategy would
rely on data integrity activities that reduce the opportunity for
products to be incorrectly identified at ports. It would also rely on
cooperation from producers so that FDA can identify sources that are
unlikely to need physical testing. However, even with such targeting,
improvements are limited by the available methodologies for assessing
threat agents and our ability to predict which tests ought to be used.
We are ramping up our food inspections, but we recognize that we
also need to inspect smarter, not just inspect more. That is why FDA is
making significant investments in technology and information resources
such as the development of the Mission Accomplishment and Regulatory
Compliance Services System, MARCS. MARCS is a comprehensive redesign
and reengineering of two core mission critical systems at FDA: FACTS
and the Operational and Administrative System for Import Support,
OASIS. OASIS supports the review and decision making process of
products for which entry is sought into the United States. We are using
funds to work to further improve targeting and using force multipliers
such as IT.
FDA also has a proof of concept project, called ``Predict,'' with
New Mexico State University under a Department of Defencse contract
which is being designed to enhance agency capability to rapidly assess
and identify import entries based on risk using relevant information
from various sources including regulated industry, trade, other
federal, State, and local entities, and foreign industry and
governments. This project, if successful, will greatly enhance FDA's
capability to be smarter in directing field activities on products of
greater risk to public health and safety. The proof of concept project
is projected to be completed in the Fall of 2004. The relentless growth
in the volume of domestic as well as imported food products, which are
increasingly in ``ready for consumer sale packaging.'' Food imports are
now growing at 19 percent per year. FDA needs to use all the potential
tools available to improve its efficiency in food security and safety
coverage.
In addition, FDA has several strategic initiatives to enhance
safety. One of these is ``Agency Initiatives to Improve Coverage,''
which includes the creation of the Southwest Import District to better
coordinate import activities on the southern border. Another is
reciprocal FDA and U.S. Customs and Border Protection training to
improve product integrity of goods offered for import and increase
enforcement actions by Customs to deter willful violations of U.S. laws
and regulations. While foreign inspections and border operations
provide some assurance that imported foods are safe, the agency
continues to work to foster international agreements and harmonize
regulatory systems. For instance, we actively participate in the
Canada/U.S./Mexico Compliance Information Group, which shares
information on regulatory systems and the regulatory compliance status
of international firms to protect and promote human health.
It is very important that American consumers trust the safety of
the food supply. FDA has made fundamental changes in how we implement
our mission of protecting the food supply, so that all Americans can
have confidence that their food has been handled under secure
conditions that provide assurance of its safety.
FDA FOIA POLICIES
Question. Dr. Crawford, my office has been working with a non-
profit patient advocacy group, the TMJ Association, in their efforts to
have two FOIA requests that are well over a year old responded to.
Their original FOIA request was made on November 1, 2002 (request
number 02017071), more than 17 months ago, and the subsequent request
was made on March 25, 2003 (request number 03004361). They have not yet
received the information requested, and have been unable to get a date
commitment by FDA as to when the information will be provided. It is my
understanding that they have been informed that FOIA requests are
severely backlogged, and the FDA has no idea when they will be able to
process their request. What is the current backlog for FOIA requests?
Answer. As of April 28, 2004, FDA has 19,369 pending FOIA
requests--17,555 have been pending more than 20 days and 1,814 have
been pending 20 days or less. The Denver District Office is responsible
for responding to the two requests from the TMJ Association. As of
April 28, 2004, Denver District Office has 369 pending FOIA requests--
357 requests have been pending more than 20 days, and 12 requests have
been pending 20 days or less.
Question. How many FDA staff are responsible for handling these
requests? Is this their sole responsibility, or do they have other
responsibilities as well?
Answer. For fiscal year 2003 the total number of personnel
responsible for processing FOIA requests was 91 FTE, 75 full time
employees, and 16 FTE work years representing personnel with part-time
FOIA duties in addition to other responsibilities.
Question. Does FDA need additional staff or resources in order to
process these requests on a timely basis?
Answer. In some agency components FOIA is a collateral duty. For
example, in most FDA field offices, Compliance Officers whose primary
responsibilities are related to the Agency's regulatory enforcement
activities also perform FOIA duties as permitted by time and regulatory
workload. Additional staff devoted to FOIA could shorten the amount of
time for processing requests.
Question. What do you believe is a reasonable length of time for a
group to wait for an information request to be processed and responded
to?
Answer. Requests are processed by the agency component that
maintains the requested records. There are a number of factors that
must be considered in order to predict a reasonable amount of time for
a request to be processed. Those factors include the volume of requests
received by the component, the complexity of requests received, the
amount of time required to search for records, the amount of time
require to review the records to determine whether information is
releasable under FOIA, and the resources available to process requests.
Question. What is the average length of time it takes to process a
FOIA request? Can you please explain the severe delay in processing
this specific one, which has taken over two years and apparently has no
end in sight? Can you please provide me a timeframe within which the
FDA will respond to these two particular FOIA requests?
Answer. Under the Electronic Freedom of Act Amendments of 1996,
agencies are permitted to establish multiple tracks for processing FOIA
requests based on the complexity of the requests and the amount of work
and time required to process requests. Some FDA components have
established multiple processing tracks. Requests are processed on a
first in, first out basis within each track. The median number of days
to process requests in the simple processing track is 19 days. The
median number of days to process requests in the complex processing
track, for more complicated requests, is 363 days. For requests that
are not processed in multiple processing tracks, the median number of
days to process is 44 days.
Due to a heavy load of regulatory cases in the Denver District
Office that must be handled by the Compliance Officers in addition to
staff shortages, FOIA work in the Denver District is being performed by
one individual on a part-time basis. This has resulted in a significant
backlog of FOIA requests. The Denver District Office expects to fill
request 02-17071 from the TMJ Association in six months, and request
03-4361 in one month.
Question. What additional efforts can this group undertake in order
to speed up their request?
Answer. The Denver District Office expects to fill request 02-17071
from the TMJ Association in six months, and request 03-4361 in one
month.
In addition, the Denver District is reviewing and evaluating its
FOIA workload and will develop a strategy aimed at reducing the backlog
of FOIA requests.
Question. What is the FDA's policy on charging for FOIA requests
made by non-profit patient advocacy groups?
Answer. The FOIA sets forth criteria that agencies must follow with
respect to charging for processing FOIA requests. Non-profit
organizations are considered Category III requesters. Such requesters
receive 100 pages of duplication and two hours of search at no charge.
If the number of pages exceed 100 and/or if the amount of search time
exceeds two hours, Category III requesters are charged based on the
FOIA fee schedule of the Department of Health and Human Services. The
fee for duplication is $.10 per page, and the fee for search is based
on the grade level of the individual who processes the request. I will
be happy to provide the current grade rates for the record.
[The information follows:]
CURRENT GRADE RATES
GS-1 through 8--$18.00 per hour
GS-9 through 14--$36.00 per hour
GS-15 and above--$64.00 per hour
In addition, requesters may make a request for waiver or reduction
of fees if their request meets the following criteria: disclosure of
the information is in the public interest because it is likely to
contribute significantly to public understanding of the operations or
activities of the Government; and, disclosure is not primarily in the
commercial interest of the requester.
IMPLICIT PRE-EMPTION
Question. Adverse reactions to prescription drugs and other
medicines take the lives of more than 100,000 Americans each year, and
millions more are seriously injured. For many years, state tort laws
have enabled some victims to receive compensation for their injuries.
It has been brought to my attention that the Food and Drug
Administration (FDA) has stepped in to protect drug companies from
liability in some of these lawsuits, potentially robbing individuals of
their only means of compensation. FDA's actions are even more troubling
when you consider that these lawsuits have other important purposes,
such as deterring future bad behavior and providing the American public
with access to important health and safety information. How many times
has the FDA interfered in lawsuits, arguing that implicit pre-emption
prohibits a plaintiff from receiving compensation for their injuries?
In how many of these cases has a court held that the plaintiff's tort
claim was implicitly pre-empted by federal law?
Answer. In the past several years, the Department of Justice (DOJ)
has represented the United States in four cases involving state-law
challenges to the adequacy of FDA-approved risk information
disseminated for FDA-approved new drugs.\1\ In each case, DOJ contended
that the state-law claim was preempted by federal law. In addition, in
some cases, DOJ argued that the state-law claim was not properly before
the court by operation of the doctrine of primary jurisdiction.\2\
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\1\ FDA also periodically becomes involved, through the Department
of Justice, in cases involving preemption of state-law requirements
under the medical device provisions of the FDCA, which include an
express preemption provision, 21 U.S.C. 360k(a).
\2\ Primary jurisdiction allows a court to refer a matter to an
administrative agency for an initial determination where the matter
involves technical questions of fact and policy within the agency's
jurisdiction. See, e.g., Israel v. Baxter Labs., Inc., 466 F.2d 272,
283 (D.C. Cir. 1972); see also 21 CFR 10.60.
---------------------------------------------------------------------------
The legal basis for preemption in these cases is FDA's careful
control over drug safety, effectiveness, and labeling according to the
agency's comprehensive authority under the FDCA and FDA implementing
regulations. If state authorities, including judges and juries applying
state law, were permitted to reach conclusions about the safety and
effectiveness information disseminated with respect to drugs for which
FDA has already made a series of regulatory determinations based on its
considerable institutional expertise and statutory mandate, the federal
system for regulation of drugs would be disrupted. I will be happy to
include information on the four cases for the record.
[The information follows:]
Bernhardt
In 2000, two individual plaintiffs filed product liability actions
in a New York court against Pfizer, Inc., seeking a court order
requiring the company to send emergency notices to users of the
prescription antihypertensive drug CARDURA (doxazosin mesylate) and
their physicians. The notices would have described the results of a
study by a component of the National Institutes of Health (NIH) that,
the plaintiffs alleged, demonstrated that Cardura was less effective in
preventing heart failure than a widely used diuretic. FDA had not
invoked its authority to send ``Dear Doctor'' letters or otherwise
disseminate information regarding a drug that the agency has determined
creates an ``imminent danger to health or gross deception of the
consumer.'' (21 U.S.C. 375(b).) The plaintiffs, nevertheless, filed a
lawsuit under state common law seeking relief that, if awarded, would
have pressured the sponsor to disseminate risk information that FDA
itself had not disseminated pursuant to its statutory authority.
FDA's views were submitted to the federal district court in the
form of a Statement of Interest.\3\ The Statement relied on the
doctrine of primary jurisdiction. The Statement also took the position
that the plaintiffs' request for a court order requiring the
dissemination of information about NIH study results to users and
prescribers of CARDURA was impliedly preempted. According to the
Statement, the court order ``would frustrate the FDA's ability
effectively to regulate prescription drugs by having the Court
substitute its judgment for the FDA's scientific expertise.'' The
Statement also noted that, if the court granted the requested order, a
direct conflict would be created between the information required to be
disseminated by the court and the information required to be
disseminated by FDA under the FDCA (in the form of the FDA-approved
labeling).
---------------------------------------------------------------------------
\3\ Statement of Interest of the United States; Preliminary
Statement, Bernhardt v. Pfizer, Inc., Case No. 00 Civ. 4042 (LMM)
(S.D.N.Y. filed Nov. 13, 2000).
---------------------------------------------------------------------------
The Statement contended that state law could not provide a basis
for requiring a drug manufacturer to issue drug information that FDA
had authority to, but did not, require. Importantly, the submission did
not argue that the state-law claim was preempted because FDA had
reached a determination that directly conflicted with the plaintiff's
view. Nor did it assert that FDA had specifically determined that the
information on the NIH study requested by the plaintiffs was
unsubstantiated, false, or misleading. In this sense, the Statement of
Interest in Bernhardt was the most aggressive, from a legal
perspective, than the three subsequent DOJ submissions on FDA's behalf
in preemption cases made during the present Administration.
The United States District Court for the Southern District of New
York accepted the primary jurisdiction argument made on FDA's behalf.
(Bernhardt v. Pfizer, Inc., 2000 U.S. Dist. LEXIS 16963, *9 (whether
the additional warnings sought by the plaintiffs were appropriate ``is
a decision that has been squarely placed within the FDA's informed
expert discretion'')). It did not address the preemption issue. The
case was voluntarily dismissed on April 22, 2003.
Dowhal
In 1998, an individual plaintiff in California asked that State's
attorney general to initiate an enforcement action against SmithKline
Beecham and other firms marketing OTC nicotine replacement therapy
products in California. (These products are marketed pursuant to an
approved new drug application.) The plaintiff contended that the FDA-
approved warnings for the defendants' products did not meet the
requirements of a state statute called the Safe Drinking Water and
Toxic Enforcement Act (Cal. Health & Safety Code 25249.5 et seq.),
also known as Proposition 65. From 1996 through 2001, FDA had
repeatedly advised the defendants that they could be liable under the
FDCA for selling misbranded products if they deviated from the FDA-
approved warning labeling for their products. FDA also advised the
state attorney general in writing in 1998 that the defendants' warning
in the labeling clearly and accurately identified the risks associated
with the products and, therefore, met FDA requirements under the FDCA.
After receiving the letter, the attorney general declined to initiate
enforcement action.
Nevertheless, in 1999, the individual plaintiff initiated a lawsuit
of his own in California state court under Proposition 65's ``bounty-
hunter'' provision, which empowers individuals to file enforcement
actions under that statute on behalf of the people of the State of
California. The lawsuit asked the court to award civil money penalties
and restitution, and to issue an injunction requiring the defendants to
disseminate warnings for their products that differed from the warnings
required by FDA. In 2000, the plaintiff filed a citizen petition with
FDA requesting that the agency require the defendants to change their
warnings to reflect the language sought by the plaintiff in the
lawsuit. FDA rejected the proposed language, determining that it lacked
sufficient support in scientific evidence and presented a risk of
mischaracterizing the risk-benefit profile of the products in a way
that threatened the public health. Although the trial court found for
the defendant, the California Court of Appeal rejected the defendant's
contention that the plaintiff's claim was preempted under the FDCA, and
allowed the lawsuit to proceed. (Dowhal v. SmithKline Beecham Consumer
Healthcare, 2002 Cal. App. LEXIS 4384 (Cal. Ct. App. 2002), argued,
Case No. S-109306 (Cal. Feb. 9, 2004).)
FDA's views were presented to the Court of Appeal of California in
an amicus curiae (``friend of the court'') brief and to the Supreme
Court of California in a letter brief and an amicus brief.\4\ All three
documents explained that the warning language sought by the plaintiffs
had been specifically considered and rejected by FDA as scientifically
unsubstantiated and misleading. Including the language would,
therefore, misbrand those products and cause the defendants to violate
the FDCA. The documents explained, further, that principles of conflict
preemption applied to the plaintiffs' claim because it was impossible
for defendants to comply with both federal and state law and because
the state law posed an obstacle to the accomplishment of the full
purposes and objectives of the FDCA.
---------------------------------------------------------------------------
\4\ Letter from Robert D. McCallum, Jr., Ass't Attorney General, et
al., to Frederick K. Ohlrich, Supreme Court Clerk/Administrator, Dowhal
v. SmithKline Beecham Consumer Healthcare LP, et al., Case No. S-109306
(Cal. filed Sept. 12, 2002); Amicus Curiae Brief of the United States
of America in Support of Defendants/Respondents SmithKline Beecham
Consumer Healthcare LP, et al., Dowhal v. SmithKline Beecham, Case No.
A094460 (Cal. Ct. App. filed Mar. 22, 2002); Amicus Curiae Brief of the
United States of America in Support of Defendants/Appellants SmithKline
Beecham Consumer Healthcare LP, et al., Dowhal v. SmithKline Beecham,
Case No. S109306 (Cal. filed July 31, 2003).
---------------------------------------------------------------------------
The California Court of Appeal rejected the preemption argument.
(Dowhal v. SmithKline Beecham Consumer Healthcare, 2002 Cal. App. LEXIS
4384, ***16-17 (Cal. Ct. App. 2002) (reversing trial court decision
granting summary judgment for defendants on preemption grounds)). On
April 15, 2004, the California Supreme Court reversed the appeals court
decision, finding a direct conflict between FDA requirements and the
state-law warning requirement advocated by the plaintiff. (Dowhal v.
SmithKline Beecham Consumer Healthcare, 2004 Cal. LEXIS 3040.)
Motus
Also in 2000, an individual plaintiff sued Pfizer in a California
court alleging, among other things, that the company had failed to
fulfill its state common law duty to warn against the risk of suicide
the plaintiff alleged was presented by ZOLOFT (sertraline HCl), an FDA-
approved drug in the selective serotonin reuptake inhibitor (SSRI)
class indicated to treat depression (among other things). On numerous
occasions, FDA had specifically considered and rejected such language
for SSRIs as scientifically unsupportable and inconsistent with FDA
determinations as to the safety and effectiveness of the products.
The United States District Court for the Central District of
California (to which the case had been removed on the ground of
diversity) rejected the defendant's preemption argument, allowing the
lawsuit to proceed. (Motus v. Pfizer Inc., 127 F. Supp. 2d 1085 (C.D.
Cal. 2000).) The court later granted the defendant's motion for summary
judgment on non-preemption grounds (196 F. Supp. 2d 984, 986 (C.D. Cal.
2001)), and the plaintiff appealed. DOJ submitted an amicus curiae
brief to the United States Court of Appeals for the Ninth Circuit on
FDA's behalf.\5\ The brief's arguments were essentially the same as the
arguments advanced in Bernhardt. In contrast to the situation in
Bernhardt, however, in Motus, FDA had specifically considered, and
rejected, the language requested by the plaintiff under state law. The
appeals court affirmed the trial court's decision earlier this year
(2004 U.S. App. LEXIS 1944 (9th Cir. February 9, 2004)).
---------------------------------------------------------------------------
\5\ Amicus Brief for the United States in Support of the Defendant-
Appellee and Cross-Appellant, and in Favor of Reversal of the District
Court's Order Denying Partial Summary Judgment to Defendant-Appellee
and Cross-Appellant, Motus v. Pfizer, Case Nos. 02-55372 & 02-55498
(9th Cir. filed Sept. 3, 2002).
---------------------------------------------------------------------------
In re PAXIL
In 2001, individuals filed suit in a California court on behalf of
past or current users of PAXIL (paroxetine HCl) against the drug's
manufacturer, GlaxoSmithKline (GSK), alleging that the company's
direct-to-consumer (DTC) broadcast advertisements for the drug failed
adequately to warn about the consequences of discontinuing the drug. In
reviewing the new drug application for the drug, FDA had found no
evidence that it was habit-forming and did not require GSK to address
that risk in FDA-approved labeling. FDA did, however, require GSK to
include in labeling statements regarding discontinuation syndrome, and
the labeling consequently recommends that doctors gradually reduce
dosages and monitor patients for syndrome symptoms. FDA reviewed
proposed DTC advertisements GSK had submitted for Paxil that said that
the drug was not habit-forming. The agency at no time determined that
this statement was misleading. In August 2002, notwithstanding FDA's
determination, the court issued a preliminary injunction prohibiting
GSK from running DTC advertisements stating that Paxil is not habit-
forming. (In re Paxil Litigation, 2002 U.S. Dist. LEXIS 16221 (C.D.
Cal. Aug. 16, 2002))
On reconsideration, the court declared that the preliminary
injunction challenged only ``FDA's . . . determination that the public
is not likely to equate the words not habit forming' as used in
direct[-]to[-]consumer advertisements with no withdrawal symptoms.'''
According to the court, ``The question of how members of the general
public are likely to interpret (or misinterpret) a statement is within
one of the courts' core competencies.'' Declaring itself ``unwilling to
blindly accept FDA's ultimate determination here,'' the court rejected
the defendants' preemption and primary jurisdiction arguments. It
nevertheless denied the injunction on the ground that the plaintiff was
not likely to succeed in demonstrating that ``non-habit forming''
statement in the advertisement is misleading. Thus, although the court
ultimately declined to award the injunctive relief sought by the
plaintiff, it continued to distinguish between FDA's determinations as
to the adequacy of drug warnings under federal law, and its own view of
warnings adequacy under state common law. (In re Paxil Litigation, 2002
U.S. Dist. LEXIS 24621 (C.D. Cal. Oct. 16, 2002).)
DOJ submitted to the court a Statement of Interest and a brief
asserting preemption.\6\ The Statement of Interest contended that a
court order requiring GSK to remove the ``non-habit-forming'' claim
from its advertisements for Paxil would be inconsistent with FDA's
determination that the company's advertisements were proper and that
Paxil is not, in fact, ``habit-forming.'' The brief contended that the
court should find the plaintiff's state-law request for a court order
preempted because it poses an obstacle to achievement of the full
objectives of Congress ``by attempting to substitute th[e] Court's
judgment for FDA's scientific expertise.'' As the brief pointed out,
FDA had specifically reviewed the advertisements, made suggestions
concerning the proper manner of presenting information relating to
whether Paxil is ``habit-forming,'' and, in the exercise of its
scientific and medical expertise, found the advertisements acceptable.
The brief also included a primary jurisdiction argument. The court
reversed its earlier award of an injunction prohibiting the
manufacturer from running advertisements that had been reviewed and
approved by FDA, but the reversal was based on a ground other than
preemption. (In re Paxil Litigation, 2002 U.S. Dist. LEXIS 24621 (C.D.
Cal. 2002).) \7\
---------------------------------------------------------------------------
\6\ Statement of Interest of the United States of America, In re
PAXIL Litigation, Case No. CV 01-07937 MRP (CWx) (C.D. Cal. filed
August 20, 2002); Brief of the United States of America, In re PAXIL
Litigation, Case No. CV 01-07937 MRP (CWx) (C.D. Cal. filed Sept. 4,
2002).
\7\ In December 2003 (296 F. Supp. 2d 1374), the litigation,
consisting of twelve action in eleven federal judicial districts, was
centralized for pretrial proceedings in the United States District
Court for the Central District of California.
---------------------------------------------------------------------------
Conclusion
As these cases illustrate, courts entertaining lawsuits filed under
state law do not always defer to FDA on matters that Congress has
placed squarely within the agency's authority. In FDA regulatory areas
characterized by comprehensive regulation and requiring a careful and
expert evaluation of scientific data and public health issues, state
coregulation can stand as an obstacle to or directly conflict with the
agency's administration of its statutory mandate. Preemption is the
constitutionally prescribed mechanism for resolving these conflicts.
The practice of citing preemption and primary jurisdiction under
the FDCA in litigation in which the United States is not a party is
well-established and substantially predates the current Administration.
DOJ and FDA participation in these cases is unusual. In the current
Administration, DOJ has participated in private state-law actions on
FDA's behalf only following a judicial finding that the action should
proceed, and only to address a state-law finding that, left
undisturbed, would undermine FDA's execution of its statutory mission
or directly conflict with federal law. Responsibility for making final
decisions whether to make submissions in private lawsuits, on
preemption, primary jurisdiction, or any other issue, rests with the
Department of Justice--not FDA itself.
Question. These arguments conflict with long-standing FDA policy.
The law appears to contradict what the FDA has argued. What motivated
FDA to change its policy?
Answer. The Government's participation in cases arising under
state-law and presenting preemption issues is consistent with past FDA
practice and with the pertinent law.
The principal enabling statute of the Food and Drug Administration
is the Federal Food, Drug, and Cosmetic Act, FDCA. Under this statute,
FDA has broad authority to protect the public health by ensuring that
foods are safe, wholesome, sanitary, and properly labeled, and that
drugs and medical products are safe and effective. (See 21 U.S.C.
393(b)(2)(A)-(C).) By operation of the Supremacy Clause of the United
States Constitution (U.S. Const. Art. VI, clause 2), the FDCA nullifies
conflicting requirements established by the States in legislation,
regulations, or common law. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.)
1, 211 (1824) (Marshall, C.J.).)
In the past, FDA has addressed conflicting state requirements in
the context of rulemaking. In 1982, for example, FDA promulgated
regulations requiring tamper-resistant packaging for over-the-counter
drugs. In the preamble accompanying the regulations, FDA stated its
intention that the regulations preempt any state or local requirements
that were ``not identical to . . . [the rule] in all respects.'' (47 FR
50442, 50447; Nov. 5, 1982.) Similarly, in 1986, FDA issued regulations
requiring aspirin manufacturers to include in labeling a warning
against use in treating chicken pox or flu symptoms in children due to
the risk of Reye's Syndrome. In the accompanying preamble, FDA said the
regulations preempted ``State and local packaging requirements that are
not identical to it with respect to OTC aspirin-containing products for
human use.'' (51 FR 8180, 8181; Mar. 7, 1986.) In 1994, FDA amended 21
CFR 20.63 to preempt state requirements for the disclosure of adverse
event-related information treated as confidential under FDA
regulations. (59 FR 3944; Jan. 27, 1994.)
In addition, for many years, conflicting state requirements have
been addressed by FDA through case-by-case participation in selected
lawsuits to which the United States has not been a party. Because FDA
lacks independent litigating authority, this participation has been by
the Department of Justice (DOJ) on FDA's behalf. The practice of
addressing conflicting state requirements through participation in
litigation dates back many years. For example, DOJ participated on
FDA's behalf in favor of preemption in both Jones v. Rath Packing
Company, 430 U.S. 519 (1977), and Grocery Manufacturers of America,
Inc. v. Gerace, 755 F.2d 993 (2d Cir. 1985). In addition, as discussed
in our response to the previous question on preemption, FDA has
recently participated in several cases involving state-law requirements
for the communication of risk information for prescription drugs. Of
note, the first--and most aggressive, from a legal perspective--of
these submissions occurred during the previous Administration--
Bernhardt case included in materials for the record.
NARMS
Question. What is the total amount of funding for NARMS, and from
what account does it come?
Answer. The total amount of funding for NARMS in fiscal year 2004
is $7.634 million. This funding is located in the Salaries and
Expenses, or S&E, account.
Question. How much is FDA giving to USDA and CDC in fiscal year
2005? How does that compare to fiscal year 2004? Please describe what
factors are used to determine the division of funds.
Answer. At this time, FDA has not determined the exact funding for
CDC and USDA for NARMS for fiscal year 2005 but plans to make decisions
by Fall 2004. In fiscal year 2004, FDA funding on NARMS will be reduced
due to government-wide rescissions. In fiscal year 2004, FDA provided
funds of approximately $1.6 million to USDA and $2 million to CDC. It
is important to point out that a large portion of the funds provided to
CDC is given to the states for the collection, isolation and
identification of bacterial isolates, which are then shipped to CDC and
the Food and Drug Administration's Center for Veterinary Medicine--
NARMS retail arm--for susceptibility testing. In determining the funds
provided to CDC and USDA, we analyze the entire NARMS program,
including the retail food arm of NARMS, and strive to fill in data gaps
and avoid duplication of organisms to be tested.
Question. How much NARMS money is currently being spent in foreign
countries, specifically Mexico? How is this money being used?
Answer. FDA is not spending any current year NARMS funding in
Mexico or other foreign countries.
Question. Does USDA or CDC spend any of their NARMS money in
foreign countries?
Answer. In fiscal year 2004 FDA is providing USDA and CDC, $1.6
million and $2 million respectively. FDA does not keep detailed records
of USDA and CDC funding for NARMS.
COUNTERFEIT DRUGS
Question. In February, FDA released a report on combating
counterfeit drugs. Several new technologies were mentioned that could
be used to this effect, including Radiofrequency Identification
tagging, color shifting inks, and holograms. Specifically regarding
color shifting inks, which I understand are currently available, has
FDA taken any action, or do you have any plans to pursue this option?
Answer. It is true that color shifting ink technology is currently
available for use on drug packaging and labeling. However, we heard
uniformly from all stakeholders that this technology is expensive and
requires significant investment of resources and time prior to
implementation. Due to the wide variety of products, packaging, and
labeling on the market, we heard from manufacturers, wholesalers, and
retailers that the decision to use color shifting inks, or any other
authentication technology, should be made by the manufacturer after a
manufacturer initiated product risk assessment. Without such an
analysis, use of color-shifting ink, or other authentication
technology, could lead to an unnecessary increase in the cost of drugs
to consumers. For example, we heard that color-shifting ink could be
appropriate for use on a very expensive, high volume brand name drug
product that is likely to be counterfeited, but not on a generic or low
volume drug product that is less likely to be counterfeited.
Based on our discussions with manufacturers, we estimate that it
would take a minimum of six to twelve months to implement a technology
such as color shifting ink from the time a decision is made to use the
authentication technology on the packaging and/or labeling of a drug
product. It could take longer if the technology, e.g., color-shifting
ink, is used on the product itself because safety studies might have to
be performed to ensure that the technology, e.g., the ink, does not
affect the safety or stability of the product.
ANIMAL DRUG COMPOUNDING
Question. Dr. Crawford, on February 10, I submitted a letter to Dr.
McClellan regarding FDA's new Compliance Policy Guidelines, issued July
14, 2003, regarding animal drug compounding. I received a response from
FDA on March 31st, and I thank you for that. However, I do have a few
more questions in light of the response.
First, the letter stated that FDA issued the CPG for immediate
implementation because of the ``urgent need to explain how it intended
to exercise its enforcement discretion regarding compounded drugs for
animal use in light of Thompson v. Western States Medical Center.''
However, this case dealt only with compounding in human drugs, not
animal drugs. How does this create an urgent need to deal with animal
drugs?
Answer. After the Western States decision, FDA revised its
enforcement policy on pharmacy compounding of human drugs. FDA was
concerned that without updated guidance regarding compounding of animal
drugs, the public would remain uncertain about whether and how FDA
would change its enforcement policy with respect to compounded animal
drugs. In addition, agency staff would lack clear guidance on
enforcement matters.
As FDA stated in its letter, although prior public comment was not
sought in this case, pursuant to the good guidance practices
regulations the public was invited to comment on the CPG when it was
issued and may comment on it at any time (68 FR 41591 (July 14, 2003)).
FDA has been reviewing those comments and will revise the guidance as
appropriate upon completion of our review.
Question. Second, the response states that two federal appeals
court decisions have held that ``the Federal Drug & Cosmetic Act does
not permit veterinarians to compound unapproved finished drugs from
bulk substances, unless the finished drug is not a new animal drug.
These cases support FDA's position that new animal drugs that are
compounded from bulk substances are adulterated under the FD&C Act and
may be subject to regulatory action.'' I have been informed that the
cases cited deal only with veterinarians compounding drugs, not
pharmacists. Why do you limit pharmacists as well as veterinarians? Is
this supported by any congressionally-enacted statutory authority,
legislative history or case law?
Answer. The principle established by the courts applies equally to
compounding by pharmacists and veterinarians.
Veterinary medicine has not traditionally utilized the services of
compounding pharmacies to the extent that they have been utilized
within human medicine. The increasing activities and presence of
compounding pharmacies in veterinary medicine is a relatively recent
development.
The Federal Food Drug and Cosmetic Act, or ``the Act'', and its
implementing regulations do not exempt veterinarians or pharmacists
from the approval requirements in the new animal drug provisions of the
Act, 21 U.S.C. Section 360b. In the absence of an approved new animal
drug application, the compounding of a new animal drug from any
unapproved drug or from bulk drug substances results in an adulterated
new animal drug within the meaning of section 21 U.S.C. Section
351(a)(5). The compounding of a new animal drug from an approved human
or animal drug also results in an adulterated new animal drug within
the meaning of 21 U.S.C. Section 351(a)(5), unless the conditions set
forth in 21 CFR 530.13(b) relating to extralable use are met.
FDA is concerned about veterinarians and pharmacists that are
engaged in manufacturing and distributing unapproved new animal drugs
in a manner that is clearly outside the bounds of traditional pharmacy
practice and that violates the Act--such as compounding that is
intended to circumvent the drug approval process and provide for the
mass marketing of products that have been produced with little or no
quality control or manufacturing standards to ensure the purity,
potency, and stability of the product.
Pharmacists and veterinarians who engage in activities analogous to
manufacturing and distributing drugs for use in animals may be held to
the same provisions of the Act as manufacturers.
Question. Finally, the final paragraph of the FDA response states
``Accordingly, the regulations that implement AMDUCA provide that
extralabel use by compounding applies only to compounding of a product
from approved drugs, and that nothing in the regulations is to be
construed as permitting compounding from bulk drugs.'' Is there in the
agency's view anything in AMDUCA's regulations or the Act that is to be
construed as not permitting compounding from bulk substances?
Answer. As previously noted, under the Federal Food, Drug and
Cosmetic Act, in the absence of an approved new animal drug
application, the compounding of a new animal drug from a bulk substance
results in a new animal drug that is adulterated as a matter of law.
This has been FDA's longstanding position, which is supported by two
federal appeals court decisions, United States v. Algon Chemical Inc.,
879 F.2d 1154 (3d Cir. 1989) and United States v. 9/1 Kg. Containers,
854 F.2d 173 (7th Cir. 1988).
CONCLUSION OF HEARINGS
Senator Specter. Thank you all very much for being here.
That concludes our hearings.
[Whereupon, at 10:48 a.m., Thursday, April 1, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005
----------
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
NONDEPARTMENTAL WITNESSES
[Clerk's note.--The subcommittee was unable to hold
hearings on nondepartmental witnesses. The statements and
letters of those submitting written testimony are as follows:]
DEPARTMENT OF LABOR
Prepared Statement of the Association of Farmworker Opportunity
Programs
Good morning Chairman Specter and members of the subcommittee. My
name is David Strauss and I represent the 50 nonprofit and public
agencies that provide job training and related services to our nation's
migrant and seasonal farmworkers.
About 3 million people labor in the fields and farms of America,
from Hawaii to Florida and Puerto Rico, from Maine to California.
Estimates are that 85 percent of the fruits and vegetables we eat are
hand harvested by farmworkers. The pay is extremely low: most
farmworkers earn less than $12,000 per year. Few farmworkers receive
the job-related benefits, such as health insurance and sick pay, which
we all take for granted. In most states, agricultural workers are not
even eligible for unemployment compensation. They live a tough life.
Many workers travel hundreds, sometimes thousands of miles in search of
work. They get paid only when they perform the work: if the weather is
bad or the crop is not as plentiful as the farmer had hoped, they
simply do not receive wages. They typically cannot afford decent
housing. Their children have to struggle mightily to even complete
their public school education. The dropout rate for farmworker youth,
especially those who migrate with their parents, is enormous.
For over 33 years the federal government has made and kept a
commitment to these hardworking people. Special federal programs were
created to recognize the reality that farmworkers often cross state
lines to work and live. Thus, we have migrant head start, migrant
health, migrant education, and the job training effort called the
National Farmworker Jobs Program. These all are federally funded and
have guidelines that acknowledge that Governors should not be placed in
a position of deciding whether or not agricultural workers qualify for
these services under state residency or other localized requirements.
Today, I want to talk with you about the last program I mentioned:
the National Farmworker Jobs Program, referred to in the budget as the
migrant and seasonal farmworker job-training program. This program
serves about 25,000 farmworkers each year, a very small percentage of
the eligible total. Most of the customers are Hispanic; all must be
American citizens or possess valid work authorization documents.
It is an extraordinary program on several counts: it is the most
successful program that the Department of Labor funds. In its most
recent national report, this program outperformed all others, including
the Job Corps, the Dislocated Workers program, the Older Americans
program, and so on. The program is operated by nonprofit and public
organizations that typically have to serve an entire state with ever-
diminishing funds. In fact, they have to compete for the grants.
Yet, they are able to hire staff who are bilingual, are culturally
sensitive, and are skilled at serving people with significant barriers
to career advancement. Characteristics such as low English proficiency,
low education levels, and extreme poverty present significant
challenges to case managers who must help farmworkers find a path to a
more stable and better paying career. And they do. Staff of the
National Farmworker Jobs Program reach out to farm laborers in camps,
fields, churches, community centers: wherever necessary to meet the
needs of these hardworking people. The hours they work and the
locations in which they provide services must be flexible, for during a
harvest, farmworkers may toil from sunup to after sundown.
The results are excellent: over 83 percent of farmworkers who
wanted training and a new job got one, and their average wage gains
exceeded $4,400 per year. That data comes from the Department of Labor,
not from our Association. Despite this excellent performance, despite
the incredible efforts of dedicated staff and despite the commitment of
program operators to achieve their goals with diminishing resources,
the Department of Labor (DOL) seeks to eliminate this program in its
budget request for 2005. DOL contends that the program is ineffective,
that it duplicates the services available to farmworkers in the One
Stop Career Centers, and that it spends too much time and money on
supportive services. They are incorrect.
Now, DOL stated the same rationale in its 2003 and the 2004 budget
requests, and you rejected it. Instead, you funded the program at just
under the 2002 level in those years. Members of the Association of
Farmworker Opportunity Programs and I have met with Department leaders
on several occasions to educate them on how the program works and to
explain how effective it is. Now we have DOL's own report that
illustrates that it is their best job-training program. Yet they
continue to resist your instruction to maintain the National Farmworker
Jobs Program.
Since I can only speculate on why the Department persists in this
stance, I will answer their three claims. First, as I said earlier the
program is amazingly effective, especially when you also consider that
many programs operate in counties with some of the highest unemployment
rates in the country. I would like to submit relevant portions of the
Workforce System Results as of September 30, 2003 issued in mid-January
of this year as proof of our success.
Secondly, this program does not duplicate services in the One Stop
Career Centers. The One Stop system created in the Workforce Investment
Act of 1998 represents an improvement in training and placement
services for job seekers. In fact, NFJP agencies are mandated partners
in that system. Labor Secretary Elaine Chao may not be aware that most
of our members have memoranda of agreement with their state's workforce
boards, and participate in the One Stop Centers. But many rural areas
do not have One Stop centers that are easily accessible to those who
work in the fields. Further, these centers seldom operate outside
normal business hours, and they have no program of outreach to hard to
serve agricultural workers. One Stops are held to program measures that
work against serving people with less than 10th grade educations. And
many rural One Stop Centers simply do not have staff who can converse
in Spanish, Creole, Vietnamese or other languages that farmworkers in
particular areas may speak. It would be a great mistake to assume that
removing the NFJP agency from the One Stop partnership would improve
services to farmworkers, as DOL has suggested. In fact, ending the NFJP
would, I am certain, end job-training services to farmworkers in most
of this nation. And that would be a great tragedy, for this program
represents access to the American Dream for migrant and seasonal
farmworkers. Whether they choose to build their careers in agriculture
or in another industry, they deserve the opportunity to achieve a
better life through training and job placement.
Finally, DOL claims that our members spend too much time and money
on what we call related assistance--services that help a farmworker
prepare for training or stabilize their economic situation while they
continue to work in agriculture. First, the data: last year, about 8.5
percent of grant funds were spent on related assistance, while over 81
percent went for job training and placement services. Now, it is true
that a majority of the farmworkers nationwide who participated in our
program received such assistance and no training. However, in states
such as California, Texas, Washington, and Arizona you will find that a
healthy majority of customers received job training and placement. In
states to which farmworkers migrate and work for relatively brief
periods, they tend to receive more life-sustaining services such as
emergency shelter, car repair vouchers, or food. Again, I remind the
committee that farmworkers do not have the same safety net as the rest
of us: no unemployment insurance, for example. And when they migrate,
they are often in places that have residency requirements for
assistance.
I dwell on this point because this seems to me to be a particularly
cruel and insensitive criticism of our members' activities--they are
charged by the Section 167 of the Workforce Investment Act with
providing related assistance, and for good reason. And I think members
of the agricultural industry would be unpleasantly surprised to learn
that DOL thinks it is wrong to help a worker who plans to harvest a
crop. Sometimes that help prevents homelessness. Sometimes the help
consists of English language training so the farmworker can better
understand the job he/she must perform. Sometimes it consists of
pesticide safety training, which enables farmers to legally employ
people who must be certified in such safety before they can work amidst
dangerous chemicals.
The Office of Management and Budget has issued an ``analysis'' of
the NFJP that is as flawed as the Department of Labor's statements.
Rather than going into it in detail today, I will instead ask you to
accept our analysis and rebuttal of their Performance Assessment Rating
Tool.
In closing, I reiterate: the National Farmworker Jobs Program does
an excellent job by the Department's own assessment. More importantly,
the program operators are keeping faith with the charge that you gave
them when you enacted the Workforce Investment Act in 1998. This
program represents a path to the American Dream for our country's
lowest paid and hardest working people. Please don't let them down.
Maintain the National Farmworker Jobs Program in the appropriation for
the Department of Labor for 2005. Thank you for this opportunity to
present testimony today.
For more information contact: David Strauss, AFOP, 4350 N. Fairfax
Drive,
Suite 410, Arlington, VA 22203 Telephone: 703-528-4141, ext. 101 email:
[email protected]
______
Prepared Statement of Rural Opportunities Inc.
Honorable Chairman, Senator Arlen Specter, and Honorable Committee
Members: I would like to sincerely thank you for this opportunity to
present testimony to the Senate Appropriations Subcommittee for Labor,
Health and Human Services, and Education.
I am submitting this testimony on behalf of Rural Opportunities
Inc., provider of the National Farmworker Jobs Program (NFJP) services
to Migrant and Seasonal Farmworkers in Pennsylvania, New York, New
Jersey and Ohio. NFJP is funded under Section 167 of the Workforce
Investment Act (WIA). I am requesting that the Subcommittee recommend
full restoration of funding for this initiative at $80 million for
Federal fiscal year 2005.
Historically, Congress has recognized the need for a nationally-
administered program to serve Migrant and Seasonal Farmworkers. The
mobility and unique socio-economic characteristics of these workers
leave them unserved or under-served by any other workforce program
convention. This fact is clearly evident, as each Congress since 1973
has passed an Act designating specific programs to serve Farmworkers:
the Comprehensive Employment and Training Act (CETA), the Job Training
Partnership Act (JTPA) and most recently, the Workforce Investment Act
(WIA). WIA was passed as a direct result of the work done by you and
your colleagues, and we thank you.
Today, although almost 6 years have passed since WIA was
implemented, nothing has changed that should alter the intent
demonstrated by the establishment and continuation of this program
effort to serve the Farmworkers of this nation. Unfortunately, as
grantees--and foremost as advocates--for Farmworkers and their needs,
we have found ourselves continuously defending the Farmworker program
and advocating for adequate funding. We also have recognized that,
although Congress has clearly demonstrated its wishes in EVERY jobs
program since 1973, the U.S. Department of Labor continues to zero out
funding for this vital program, while at the same time hailing it as
one of their most successful.\1\
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\1\ Workforce System Results, www.dol.gov, page 6.
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Although it may seem cliche in 2004, we are still forced to ask the
question: ``Are Farmworkers better served today than they would be if
no program existed?'' The answer is an unqualified ``Yes.'' NFJP
nationally had an 84.6 percent successful placement rate (Entered
Employment Rate) for Farmworkers who entered training in PY 2002 (July
2002 to June 2003).\2\ According to USDOL statistics as of 30 September
2003, ROI--across our entire service area--had a 100 percent success
rate in placing Farmworkers in jobs after training.
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\2\ PY 2002 Preliminary Grantee performance for the NFJP,
wdsc.doleta.gov/msfwPY02.
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Why does the Office of Management and Budget in their program
analysis question the actions of Congress in establishing emergency and
supportive services? We are directed by Section 167 of the Workforce
Investment Act to provide emergency and supportive services to
stabilize the agriculture workforce. Ensuring that our nation's
agricultural employers continue to have access to a stable agricultural
workforce required less than 9 percent of the total funds appropriated
for the NFJP. Agricultural stabilization services that meet the short
term emergency needs of Farmworkers enable them to be available for
work in our nation's fields at peak harvest times.
With regard to the impact of NFJP job placement, ROI statistics \3\
for PY 2002 show an average wage gain of $5,611 in Pennsylvania, $4,372
in New York, $6,519 in New Jersey and $3,925 in Ohio. The national
average across all NFJP programs for the same wage measure is
$4,413.\4\ Ironically, the average wage gain reported by the One Stop
system for the same period was only $3,094,\5\ while serving a
population confronted by far fewer barriers to employment.
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\3\ Rural Opportunities Inc. Management Information System, PY
2002.
\4\ Workforce System Results, www.dol.gov, page 6.
\5\ Workforce System Results, www.dol.gov, page 7.
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As compelling as this economic information is, nothing speaks
louder than the words of the participants, your constituents, who have
begun to experience the American dream. I have requested and received
permission from some of our participants to use their stories in this
testimony.
To set the background for these stories, let me describe the
typical Farmworkers served in the NFJP programs Rural Opportunities
Inc. operates. The average participant is a young Hispanic male or
female. Of those served in PY 2002, 91.6 percent were Hispanic, 64.7
percent were 21-44 years old, 71.5 percent had limited English speaking
skills and 84.8 percent dropped out during or before high school. Most
were members of families who had been working in agriculture since
their birth. In fact, over 69 percent knew agriculture as their only
work experience. These are the very characteristics that would preclude
our program participants from being served by the local One Stop.
Ofelia Carmona is an Hispanic woman aged 41. She was born into a
Farmworker family. At age 6, she began working in the fields with her
13 brothers and sisters. Married at age 14, Ofelia dropped out of
school and began migrating with her husband, and soon children, to the
fields and orchards of the Northeast. While pregnant with her 4th
child, she and her husband decided they wanted more for their children.
With the help of Rural Opportunities Inc., Ofelia pursued her GED. She
attended GED class in the morning and work experience at a Migrant
Health Clinic each afternoon. After completing her GED, Ofelia was
hired full-time by the Clinic. But she was not through with her
efforts; Ofelia returned to Community College and, while continuing her
full-time employment, obtained a Nursing Assistant Associates Degree.
Today, Ofelia is the Director of a Migrant Head Start Center and is
working to achieve a Bachelors Degree in Early Childhood Education.
Juan Luna's story is not unlike that of Ofelia; Juan is a 36-year-
old Hispanic male. He dropped out prior to completing high school, had
limited English speaking skills and no transportation, and his only
work experience had been as a migrant following the crops. He was not
in a position to enter the traditional job market. ROI began by helping
Juan access English as a Second Language classes. Then, when his
English skills had begun to improve, ROI assisted him in entering
Occupational Skills Training at the Metal Working Institute, where he
learned the skills to become a Machinist. Today, Juan is employed with
the Hauser Corporation as a machine operator and will soon complete his
second year on the job.
Cipriano Rodriguez migrated from Mexico 12 years ago to pick
apples. Discouraged by the poor pay, he finally left farm work after
many years for a factory job, although his interest in agriculture
remained strong. Learning of the services provided by Rural
Opportunities, Inc., he established the goal of obtaining his
Commercial Driver License and returning to agriculture--and his love
for the land. He completed training and passed the required tests, and
was able to obtain year-round employment at a large farm in the Hudson
Valley, driving produce to processing and storage facilities. Four
years ago, he became a United States citizen.
Ofelia, Juan, Cipriano . . . these are not the customers of the
traditional One Stop system. These are the customers of the National
Farmworker Jobs Program grantees. They are not unlike the 328
participants ROI assisted to gain full-time, year-around employment in
PY 2002.\6\
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\6\ www.workforceatm.org
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NFJP program served 5,612 Farmworkers in PY 2002 nationwide.\7\
Without NFJP, who would serve these individuals? The One Stop system?
The same system that served less than 1 percent of this population in
PY 2002? The One Stop system does not have language or culturally
appropriate staff and cannot be expected to develop appropriate
staffing in a few short months. The One Stop system does not do
outreach to overcome Farmworkers' barriers to services, such as lack of
transportation, isolation, and sunrise to sunset workdays. Nor can
Farmworkers, if they somehow manage to access the One Stop system, be
expected to use a computerized system for job search assistance and
labor market information--a system targeting high school graduates, an
education level far beyond that attained by the average Farmworker.
---------------------------------------------------------------------------
\7\ www.workforceatm.org
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Throughout our history, Rural Opportunities Inc. has always sought
to assist Farmworkers in achieving their dreams by placing them in jobs
of their choosing--within or outside of agriculture. Often Farmworkers
wish to upgrade skills to stay on the farm and find a full-time job in
agriculture or an agriculture-related industry. In PY 2002,
agricultural upgrades accounted for 30 percent of all of the jobs in
which ROI assisted Farmworkers to find placements. In Pennsylvania, we
have achieved significant success in the past by working with the
Mushroom Industry to design and implement job training. In New York, we
have done the same with the Dairy Industry. ROI continues to experience
high demand from Farmworkers for training in welding and in obtaining
Class I Licenses, both of which secure higher paying year-round
employment on the farms. Ironically, a concern we often hear from those
in Agriculture and Ag-related Industries is that their interests are
not met by the primarily urban or village-based One Stop System.
Although as a case management and individual skills-based effort NFJP
does not train as many Farmworkers for skilled farm positions as the
Industry would like, NFJP does address the Industry's needs.
In his March 2004 presentation to the ROI Board of Directors,
George Lamont, a New York State Grower and Executive Director of the
New York State Horticultural Association, presented his hierarchy of
needs for the Farmworkers he employs: Job Skills Training and English
as a Second Language were two of the top three.
The One Stop Delivery System often has recognized how under-
equipped it is to meet the needs of the Farmworker population and
supports the continuation of the National Farmworker Jobs Program, as
evidenced in the following excerpts:
--Your agency's interaction with migrant and seasonal farmworkers, a
population that is traditionally underserved by other agencies,
is integral to their well-being.\8\
---------------------------------------------------------------------------
\8\ Joseph Kuchere, Workforce Investment Board Chair, Niagara
County Workforce Investment Board, letter of support, 2003.
---------------------------------------------------------------------------
--We realize that without the services provided by the NFJP,
farmworkers would not have access to training and job placement
outside of agriculture due to the multi-barriers many of them
possess. The removal of these barriers requires staff that has
the skills and cultural sensitivity to assist this special
population as well as those who can provide services evenings
and weekends to meet the critical demand of migrant and
seasonal farmworkers.\9\
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\9\ Ana Maria Murabito, Council of Industry of Southeast New York,
letter of support, 2003.
---------------------------------------------------------------------------
--You have provided these services and truly changed the lives of
hundreds of farmworkers by providing needed tools that lead to
self-sufficiency for them and their families.\10\
---------------------------------------------------------------------------
\10\ Ibid.
---------------------------------------------------------------------------
--Your agency staff has the needed skills and cultural sensitivity to
assist this population to overcome barriers pertaining to self-
sufficiency for themselves and their families.\11\
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\11\ Glenn L. Decker, Commissioner of Social Services, Ulster
County, letter of support, 2003.
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The National Farmworker Jobs Program grantees have developed a
sophisticated service delivery infrastructure in the past 30+ years,
capable of meeting farmworkers' needs and generating high levels of
success. As an NFJP grantee, Rural Opportunities Inc. has built a
support structure of additional resources that allows us to leverage
NFJP dollars--for every $1 provided by NFJP, we can bring an additional
$3 to bear on the host of problems faced by Farmworkers in each state
we serve. The NFJP is more successful because of this and the
Farmworker population is far better served. ROI has been recognized for
the fact that 96 cents of every funding dollar go to client
services.\12\
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\12\ Rochester Business Journal, Non-profit Agencies Vary Widely in
Outlay for Overhead Expenses. January 4, 2002; Volume17; Number 40.
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In closing, ROI requests that the Subcommittee recommend an
appropriation of $80,000,000--restoring the NFJP program to full
funding and recognizing the enormous potential of the NFJP program
grantees. Though this appropriation will not ensure that every eligible
Farmworker receives the services needed, it will enable the program to
hold its ground in providing high quality, culturally appropriate
services to this population so desperately in need.
______
Prepared Statement of the California Workforce Investment Board
My name is Morgan Clayton, Chairman of the Kern County California
Workforce Investment Board. I whole-heartedly support the continued
funding of the National Farmworkers Jobs Program, as authorized in
section 167 of the Workforce Investment Board (WIA). While our Board
represents a Grantee for this program, we also serve as the Local Area
for the WIA formula-funded programs in the California counties of Kern,
Inyo and Mono. From this unique perspective we have come to appreciate
the need for the National Farmworker Jobs program and urge its
continued full funding in fiscal year 2005 and beyond.
In providing services to both Farmworkers and the general
population for more than 20 years, it has become clear that the farm
workers have unique needs in the areas of basic skills, Vocational
English-as-a-Second Language, job training and access to available
services. A separate program ensures that these needs continue to be
addressed. While we continue to enjoy many successes in serving farm
workers through our network of rural one-stop career centers, those
one-stops simply could not exist without a serious commitment of
federal funding to targeted rural workers, especially farm workers.
On behalf of the Workforce Invest Board of Kern County, I am adding
our support for the continued, full funding of the National Farmworker
Jobs Program.
______
Prepared Statement of the National Association of State Workforce
Agencies
Chairman Specter, Senator Harkin, and distinguished Members of the
Subcommittee. On behalf of the National Association of State Workforce
Agencies, I thank the Subcommittee for the opportunity to share
information on the contributions our members provide in strengthening
our nation's economy by linking workers and jobs. The members of our
association constitute state leaders of the publicly-funded workforce
investment system vital to meeting the employment needs of business and
workers. It is the funding you appropriate that makes much of the
workforce system services and infrastructure possible.
Mr. Chairman, the nation's publicly-funded workforce system
continues to build on the critical link between businesses in need of
employees and workers in need of employment. The state agencies
administering job training and employment assistance programs
throughout our country are cognizant of the need to provide effective
services. We recognize it is no longer enough to wait for a dislocated
worker to walk through the door of our one-stop offices, or for the
phone to ring from a prospective employer in need of skilled workers.
Instead, the workforce system is transforming its operations to meet
employer demands for skilled workers in the 21st century.
One can look at the latest Workforce System Results report
published by the Employment and Training Administration (ETA) for
evidence of our workforce system's performance and continued
improvement. This report shows state workforce programs ``are either
meeting their Government Performance and Results Act (GPRA) goals, or
have improved their performance from the previous year.'' These results
were achieved while our nation's economy continues its recovery with
sustained high demand on our system. Although the system continues to
improve, we are concerned the upward trend in performance might level
off in the near future if it does not obtain sufficient resources to
meet an ever-growing demand.
A recent survey of state workforce agency administrators yields a
consistent concern that the infrastructure needed to maintain services
business and workers have come to expect is aging and in need of
repair. We are becoming increasingly aware of limitations to the
expectation that we can do more with less and the effect of level or
reduced funding on the quality and quantity of our services. Although
we strive to continue improving our service levels regardless of our
annual appropriations, under funding of our programs makes state
decision-making harder and ultimately can lesson the quality and
quantity of services we will be able to provide.
STATE UNEMPLOYMENT INSURANCE ADMINISTRATION GRANTS
The Social Security Act requires the Secretary of Labor to allocate
grants to states that are necessary for proper and efficient
administration of their unemployment insurance programs. However, the
President's budget has not proposed sufficient amounts and Congress has
often appropriated less than the President's insufficient request for
many years. The result is states often receive less than is necessary
for proper and efficient administration of their unemployment
compensation programs.
Insufficient funding has forced many states to delay indefinitely
technological upgrades. Many states are unable to automate their aging
benefits and tax systems. The inability to improve infrastructure
hampers states ability to combat fraud, such as identity theft and
unemployment tax evasion.
NASWA's request for state administration of unemployment
compensation in fiscal year 2005 exceeds the Administration's request
by $439 million, totaling $3.140 billion. This amount is estimated to
be necessary for the states to operate their unemployment compensation
programs properly. We believe this amount is necessary because a new
budget formulation and allocation system, known as the Resource
Justification Model (RJM), provides estimates of the amounts states
need for proper and efficient administration of the UI program.
NASWA also requests Congress enact an immediate transfer of $9
billion as a special Reed Act distribution to state trust fund accounts
to improve trust fund solvency, avoid employer tax hikes, and improve
UI administration, employment services and unemployment benefits.
Unemployment trust fund solvency has continued declining during the
past year. State unemployment trust fund balances fell from $51.57
billion on September 30, 2001 to $28.13 billion on September 30, 2003.
Benefits increased from $27.35 billion in fiscal year 2001 to $41.8
billion in fiscal year 2003. Six months ago, one state borrowed to
maintain trust fund solvency. Today eight states are borrowing. Many
other states are planning to borrow or substantially increase state
unemployment taxes or cut unemployment benefits to maintain trust fund
solvency.
If a transfer of $9 billion as a Reed Act distribution does not
occur in the next five months, many states will be forced to borrow,
cut benefits, or collect additional revenue through state unemployment
payroll taxes on employers. Collection of additional employer taxes is
unnecessary given the $19.9 billion balance credited to the federal
unemployment trust fund accounts. Using already-paid employer
unemployment taxes for the UI and ES programs is a far better purpose
during this period of high unemployment than merely maintaining
balances in federal trust fund accounts.
Mr. Chairman, as you know the workforce system received an $8
billion Reed Act distribution in 2002. Some in Congress and the
Administration have said states are ``sitting'' on these funds, not
using them in valuable ways. We can assure you that this is not the
case. A recent survey of NASWA members found states have used all of
the 2002 distribution for economic stimulus, improved UI benefits and
administration and employment services. The $8 billion allowed states
to cut unemployment payroll taxes for employers by more than $4 billion
and improve state unemployment trust fund solvency, unemployment
insurance administration and employment services. A Reed Act
distribution in 2004 would stimulate further the economy by allowing
many states to avoid raising employer taxes that will increase the cost
of hiring new employees and slow the rate of job creation.
WORKFORCE INVESTMENT ACT & EMPLOYMENT SERVICE PROGRAMS
ETA Assistant Secretary DeRocco recently said in her testimony
before this subcommittee, the WIA programs that are delivered by the
state and local workforce partners continue to meet or substantially
meet the majority of their established performance targets this past
year. Some 83 percent of adults and 89 percent of dislocated workers
were still working in the third quarter following receiving services
against respective GPRA targets of 80 percent and 88 percent
respectively. After receiving services, adults increased their annual
earnings on average by $3,030 and dislocated workers averaged 88
percent of their pre-dislocation earnings.
For older youth ages 19 to 21 receiving services by the publicly-
funded workforce system, 70 percent were employed in the first quarter
after receiving services. Sixty-three percent of younger youth (ages 14
to 18) who entered the program without a high school diploma or
equivalent, attained a diploma or equivalent by the first quarter after
receiving services.
In order to meet the needs of both workers and businesses over the
coming year, NASWA recommends the following funding levels for WIA
programs for fiscal year 2005: $1.5 billion for dislocated worker state
allocations; $950 million for adult training; and $1.128 billion for
youth training activities. These amounts represent the funding levels
allocated for the system in fiscal year 2002.
Our members are concerned about the Administration's proposed
funding cut of $91 million to Employment Service (ES) programs and the
elimination of the $35 million for Reemployment Services. Funding for
employment services has not been increased in over 8 years. However,
most states have supplemented their budget with state or Reed Act
funds. While NASWA members can support funding for new initiatives
proposed by the Administration ($250 million for Community Colleges,
$50 million for piloting Personal Reemployment Accounts, and $35
million for the Prisoner Reentry Initiative), they are concerned about
reductions to existing programs.
NASWA requests $330.5 million more than was requested by the
Administration for fiscal year 2005 employment service state allotments
for a total of $991.7 million. In many parts of the country, the one-
stop career centers are built on the ES program. The Administration,
state workforce agencies, and local One-Stop centers have accepted a
new focus on the business customer. The majority of services provided
to the business community have been provided with ES funds. During the
period ending December 31, 2003, the ES provided service to 9.2 million
applicants.
TRADE ACT FUNDING
Each year, many states deal with a shortfall of funding for worker
training benefits under the Trade Act. States have been forced to
freeze spending and turn many workers away. Turning workers away has
become especially prevalent over the past few years as the number of
trade impacted workers rises. We look forward to working with Congress
on finding sufficient spending levels for trade programs in fiscal year
2005.
LABOR MARKET INFORMATION
NASWA supports a return to ETA's earlier investment levels of $150
million for one-stop/America's Labor Market Information System (ALMIS)
funding. The importance of adequate funding to state agencies for labor
market information has intensified as states attempt to work with the
Administration on its new ``high growth job training initiative.''
State and local labor market information and high quality employment
projections are critical to the identification of industry sectors and
occupations where the employment growth will occur and ensure that
training dollars are wisely invested.
NASWA also calls for the Administration's leadership and support
for funding of the new collaborative effort between the Bureau of Labor
Statistics and the Bureau of Census to develop a unified wage record
program. This new effort will afford better measurement of program
performance and improved understanding of the labor market.
VETERANS EMPLOYMENT AND TRAINING PROGRAMS
Two year's ago, Congress approved the Jobs for Veterans Act, giving
states greater flexibility to serve their veteran populations. NASWA
supported many provisions in this legislation, especially those that
gave states more flexibility in integrating the veterans' employment
and training programs into the one-stop career center system.
The Jobs for Veterans Act requires states to submit to the
Secretary of Labor, ``a plan that describes the manner in which the
state shall furnish employment, training, and placement services
required under this chapter for the program year.'' NASWA members
believe the annual plan required by the Jobs for Veterans Act will be
greatly improved by moving the funding for these programs from a fiscal
year to a program year funding cycle. By transitioning funding to a
program year (July 1 to June 30) and aligning it with most other
employment and training programs, the plans that state workforce
agencies submit to the Department will reflect future program year
services based on established budget outlays. Program year funding
supports integrating VETS-funded programs into WIA one-stop career
center systems and planning and performing on the same cycle as other
one-stop partners. The workforce system looks forward to another year
of high performance and improvement. NASWA greatly appreciates your
support. Thank you for considering our request.
______
Prepared Statement of the National Youth Employment Coalition
On behalf of the National Youth Employment Coalition (NYEC) and its
more than 270 members, I am writing to thank you for being the champion
for the Department of Labor's Reintegration of Young Offenders program.
If not for your heroic efforts, this small, yet important program would
have ceased to exist years ago.
As you know, the Administration's fiscal year 2005 budget proposes
to supplant the $49 million Reintegration of Young Offenders program
with a new $90 million Prisoner Reentry Program. While NYEC applauds
the Administration for its commitment to helping adult prisoners
successfully return to society, details are still vague about how or
whether this new program would involve young offenders. Additional
resources to help reintegrate adult prisoners to society should not
come at the expense of existing programs that help reintegrate
incarcerated youth and prevent other court-involved youth from
recidivating and being incarcerated.
According to the Bureau of Justice Statistics, approximately
120,000 youth under the age of 18 are currently incarcerated in
juvenile detention centers, state prisons, and local jails. Most will
be released in the next few years. While youth in general are being
hard hit by the sluggish economy, court-involved youth face additional
barriers to employment. There is a growing consensus among youth
development experts that youth who come under court supervision have
multiple issues that must be addressed in comprehensive and coordinated
ways, if they are to attain employment at wages that will sustain a
constructive life path. DOL's Youth Offenders Demonstration grantees
provide coordinated services to young offenders, gang-involved youth,
and at-risk youth to help them find employment, reduce dependency, and
break the cycle of crime and recidivism. Court-involved youth who are
at-risk of being incarcerated, and youth already in secure facilities
receive training and employment opportunities in addition to education;
substance abuse treatment as needed; mental health services; aftercare;
housing assistance and family support services; and juvenile justice
supervision. Several of our members have received competitive grants
through the Reintegration of Young Offenders program in the past and
many others plan to apply when the Department of Labor announces that
funds are available for the fiscal year 2003 grant cycle.
We must sustain our national investment in services and support for
court-involved youth to enable these youth to positively contribute to
their communities. Without resources such as the Responsible
Reintegration of Young Offenders program, many more will fail to
successfully transition into productive employment and instead will
join the more than 2 million people currently incarcerated.
Again, thank you so much for your long-standing commitment to
court-involved youth.
______
Prepared Statement of the National Youth Employment Coalition
The National Youth Employment Coalition (NYEC) is a network of over
270 youth employment, education, and development organizations
dedicated to promoting policies and initiatives that help young people
succeed in becoming lifelong learners, productive workers and self-
sufficient citizens. We urge you to increase federal funding for youth
employment/development programs under the Workforce Investment Act
(WIA). In addition, we urge you to restore funding for the
Reintegration for Young Offenders Program to its fiscal year 2003 level
of $54 million, and ensure that these funds continue to be targeted at
helping reintegrate incarcerated young offenders and prevent court-
involved youth from recidivating or being incarcerated.
We understand that this year's federal budget is particularly tight
and we face a historically large deficit. However, our nation is facing
a silent crisis--hundreds of thousands of youth are not being provided
the opportunities they need to develop the academic and job skills they
need to succeed in the 21st century workplace. We continue to hear
reports that youth are having difficulty finding jobs in this sluggish
economy because many employers are hiring adults for jobs for which
they would hire youth in a tighter labor market. These reports are
confirmed by the Bureau of Labor Statistics' January 2004 data, which
shows that youth (age 16 to 19) have lost more than one million jobs
since January 2000; and only 34 percent of youth were employed (part-
or full-time) in January 2004--marking the lowest youth employment rate
for the month of January since 1965.
Despite record levels of youth joblessness, combined federal
funding for the WIA youth formula and the Youth Opportunity Grant
Program has been cut by more than 26 percent--from $1.352 billion in
fiscal year 2002 to $995 million in fiscal year 2004. The
Administration's fiscal year 2005 budget proposes a slight increase to
$1.001 billion for the WIA youth formula; however, the House WIA
reauthorization bill and the President's reauthorization plan propose
using 25 percent of the formula funds to launch a new National
Challenge Grant program. While we support new programs that help youth
prepare for jobs and careers and prevent them from dropping out of
school, funding for such a new program should not come at the expense
of current programs that are already stretched to the breaking point.
We cannot afford to allow our nation's youth development/employment
system to erode further. Therefore we were very pleased to learn that
the Senate's fiscal year 2005 budget resolution includes an amendment,
sponsored by Senators Enzi (R-WY) and Cantwell (D-WA), that would
increase WIA funding by $250 million in fiscal year 2005. We urge you
this year to begin increasing funds for the WIA youth formula to
restore funding to the $1.4 billion level. An additional $250 million
should be provided in the event that the new National Challenge Grant
program is authorized as a result of WIA reauthorization.
The Administration's fiscal year 2005 budget also proposes to
supplant the $49-million Young Offenders program with a new $90-million
Prisoner Reentry Program. While NYEC applauds the Administration for
its commitment to helping prisoners successfully return to society,
details are still vague about how or whether this new program would
involve youth. Additional resources to help reintegrate adult prisoners
to society should not come at the expense of existing programs that
help reintegrate incarcerated young offenders and prevent court-
involved youth from recidivating or being incarcerated. At minimum,
funds currently targeted at court-involved youth under the
Reintegration for Young Offenders Program should be maintained to
fiscal year 2003 levels ($54 million) and set aside for young offenders
within the structure of the new prisoner reentry program.
According to the Bureau of Justice Statistics, approximately
120,000 youth under the age of 18 are currently incarcerated in
juvenile detention centers, state prisons, and local jails. Most will
be released in the next few years. While youth in general are being
hard hit by the sluggish economy, court-involved youth face additional
barriers to employment. There is a growing consensus among youth
development experts that youth who come under court supervision have
multiple issues that must be addressed in comprehensive and coordinated
ways, if they are to attain employment at wages that will sustain a
constructive life path. DOL's Youth Offenders Demonstration grantees
provide coordinated services to young offenders, gang-involved youth,
and at-risk youth to help them find employment, reduce dependency, and
break the cycle of crime and recidivism. Court-involved youth who are
at-risk of being incarcerated, and youth already in secure facilities
receive training and employment opportunities in addition to education;
substance abuse treatment as needed; mental health services; aftercare;
housing assistance and family support services; and juvenile justice
supervision.
We understand that you face difficult decisions this year as you
seek to spread limited federal resources for a range of national needs.
Yet we must sustain our national investment in services and support
disadvantaged youth to enable these young people to positively
contribute to their communities. Without resources such as the WIA
youth formula and the Responsible Reintegration of Young Offenders
program, many more will fail to successfully transition into productive
employment.
We thank the Committee for its attention to these important
programs for our youth and our emerging workforce.
______
Prepared Statement of the National Coalition for Homeless Veterans
INTRODUCTION
The National Coalition for Homeless Veterans appreciates the
opportunity to submit recommendations on fiscal year 2005
appropriations for and program management issues related to the U.S.
Department of Labor (DOL).
The National Coalition for Homeless Veterans (NCHV), established in
1990, is a nonprofit organization with the mission of ending
homelessness among veterans by shaping public policy, promoting
collaboration, and building the capacity of service providers. NCHV's
nearly 250 member organizations in 42 states and the District of
Columbia provide housing and supportive services to homeless veterans
and their families, such as street outreach, drop-in centers, emergency
shelter, transitional housing, permanent housing, recuperative care,
hospice care, food and clothing, primary health care, addiction and
mental health services, employment supports, educational assistance,
legal aid and benefit advocacy.
The VA estimates that more than 299,000 veterans are homeless on
any given night; more than 500,000 experience homelessness over the
course of a year. Conservatively, one of every three homeless adult
males sleeping in a doorway, alley, box, car, barn or other location
not fit for human habitation in our urban, suburban, and rural
communities has served our nation in the Armed Forces. Homeless
veterans are mostly males (2 percent are females); 54 percent are
people of color. The vast majority are single, although service
providers are reporting an increased number of veterans with children
seeking their assistance; 45 percent have a mental illness; 50 percent
have an addiction.
America's homeless veterans have served in World War II, Korea, the
cold war, Vietnam, Grenada, Panama, Lebanon, anti-drug cultivation
efforts in South America, Afghanistan, and Iraq. 47 percent of homeless
veterans served during the Vietnam Era. More than 67 percent served our
nation for at least 3 years and 33 percent were stationed in a war
zone.
Male veterans are twice as likely to become homeless as their non-
veteran counterparts, and female veterans are about four times as
likely to become homeless as their non-veteran counterparts. Like their
non-veteran counterparts, veterans are at high risk of homelessness due
to extremely low or no income, dismal living conditions in cheap hotels
or in overcrowded or substandard housing, and lack of access to health
care. In addition to these shared factors, a large number of at-risk
veterans live with post traumatic stress disorders and addictions
acquired during or exacerbated by their military service. In addition,
their family and social networks are fractured due to lengthy periods
away from their communities of origin. These problems are directly
traceable to their experience in military service or to their return to
civilian society without appropriate transitional supports.
Contrary to the perceptions that our nation's veterans are well-
supported, in fact many go without the services they require and are
eligible to receive. One and a half million veterans have incomes that
fall below the federal poverty level. Neither the VA, state or county
departments of veteran affairs, nor community-based and faith-based
service providers are adequately resourced to respond to these
veterans' health, housing, and supportive services needs. The VA plays
only a limited role in providing employment services to veterans,
administering just one small supported employment program for veterans
with serious disabilities.
The U.S. Department of Labor and state and local workforce agencies
bear primary responsibility for ensuring that veterans are provided
opportunities to prepare for and obtain productive employment.
Accordingly, we urge Congress to provide full funding for the programs
of the Department of Labor Veterans Employment and Training Service
(VETS) in order to ensure that our nation's workforce services system
is equipped to fulfill their obligations to our nation's veterans.
FISCAL YEAR 2005 APPROPRIATION RECOMMENDATION--HOMELESS VETERAN
REINTEGRATION PROGRAM
The Homeless Veterans Reintegration Program (HVRP), within the
Department of Labor's Veterans Employment and Training Service (VETS),
provides competitive grants to community-based, faith-based, and public
organizations to offer outreach, job placement and supportive services
to homeless veterans. HVRP is the primary employment services program
accessible by homeless veterans and the only targeted employment
program for any homeless subpopulation. Homeless veterans have many
additional barriers to employment than non-homeless veterans due to
their lack of housing. HVRP grantees remove those barriers through
specialized supports unavailable through other employment services
programs. Grantees are able to place HVRP participants into employment
for $2,100 per placement, a tiny investment for moving a veteran out of
homelessness, and off of dependency on public programs.
DOL estimates that 16,800 homeless veterans will be served through
HVRP at the fiscal year 2004 appropriation level of $19 million. This
figure represents just 3 percent of the overall homeless veteran
population, which the Department of Veterans Affairs estimates numbers
more than 500,000 over the course of a year. An appropriation at the
authorized level of $50 million would enable HVRP grantees to reach
approximately 44,000 homeless veterans.
HVRP grants are funded on a 3-year cycle. DOL representatives have
indicated that if funding is not increased for the program this year,
it is unlikely there would be a competition for new start grants in
fiscal year 2005. Additionally, HVRP is being used as the account to
fund a joint Department of Labor and Department of Veterans Affairs
initiative authorized by Congress to assist veterans incarcerated in
their reentry to the community. This decision essentially adds a new
purpose to the HVRP program, for which additional funds are needed.
We urge Congress to appropriate at least $50 million for HVRP in
fiscal year 2005 Labor-HHS-Education appropriations legislation.
[In millions of dollars]
----------------------------------------------------------------------------------------------------------------
Fiscal year
------------------------------------------------------
2005
2003 2004 administration 2005 NCHV
----------------------------------------------------------------------------------------------------------------
Funding for Homeless Veterans Reintegration Program...... 18.2 19.0 19.0 50.0
----------------------------------------------------------------------------------------------------------------
FISCAL YEAR 2005 APPROPRIATION RECOMMENDATION--VETERANS WORKFORCE
INVESTMENT PROGRAM
The Veterans Workforce Investment Program (VWIP), within the
Department of Labor's Veterans Employment and Training Service (VETS),
provides grants to states and community-based, faith-based, and local
public organizations to offer workforce services targeted to veterans
with service connected disabilities, with active duty experience in a
war or campaign, recently separated from the service, or facing
significant barriers to employment (including homelessness). VWIP
grants last for twelve months and currently have a limit of $255,000.
The fiscal year 2004 appropriation for VWIP is $7.5 million.
At least 80 percent of total VWIP funds is distributed via
competition. State governments have traditionally been the exclusive
eligible applicant for competitive funds. The states then publish
requests for proposals, to which local governments, workforce
investment boards, and community organizations may respond. The states
monitor the projects and frequently provide matching funds to increase
opportunities. While matching funds are not required, applicants can
gain up to ten points on their application if they demonstrate
effective leveraging. In 2003, VWIP competitive funds were awarded to
state agencies in AL, CA, HI, IN, ME, MA, PA, TN, and TX.
VETS may reserve 20 percent of total VWIP funds for discretionary
grants. VETS uses discretionary funds for studies, demonstration
projects, and additional funding to supplement competitive grants.
Discretionary grant applications are accepted directly from local
governments, workforce investment boards, community-based, and faith-
based organizations. In 2003, VWIP discretionary funds were awarded to
organizations in CA, DC, FL, MS, NY, SC, OH, PA, and VA.
Both those agencies that receive VWIP funds and those hoping to
apply face the problem of resource scarcity. Due to funding
limitations, agencies and organizations receive VWIP funds in only 16
states. The need for the type of targeted assistance that VWIP offers
is clearly needed in all states. Additionally, caps on the size of
grant awards make it difficult for existing grantees to recruit and
retain staff. This limits program effectiveness and the collaborative
process.
We urge Congress to appropriate at least $33.5 million for VWIP in
fiscal year 2005 Labor-HHS-Education appropriations legislation.
[In millions of dollars]
----------------------------------------------------------------------------------------------------------------
Fiscal year
------------------------------------------------------
2005
2003 2004 administration 2005 NCHV
----------------------------------------------------------------------------------------------------------------
Funding for Veterans Workforce Investment Program........ 7.5 7.5 7.5 33.5
----------------------------------------------------------------------------------------------------------------
program management recommendation--priority of service for veterans in
DOL JOB TRAINING PROGRAMS
The Jobs for Veterans Act (Public Law 107-288) establishes a
priority of service for veterans in the receipt of employment,
training, and placement services provided under qualified job training
programs of the Department of Labor. We request the Committee's
assistance in ensuring that qualified job training programs fully
extend priority of service for veterans as required by this law.
We recommend that the Committee, through report language, urge the
Secretary of Labor to ensure that states, localities, and nonprofit
organizations receiving workforce investment funds from the Department
of Labor screen all applicants for services for military service status
and implement the priority for those qualified. Further, we recommend
that the Committee urge the Secretary of Labor to develop and
disseminate a guide for veterans in accessing workforce investment
services.
In addition, we recommend that the Committee encourage the
Secretary to develop and disseminate a guide for assisting veterans
service organizations and homeless veteran service providers in
accessing workforce investment funds and workforce investment planning
processes. Also, we recommend that the Committee encourage the
Secretary to develop and disseminate a technical assistance guide to
inform state and local workforce systems on the workforce services
needs of veterans, the current limitations of veteran-specific programs
in meeting those needs, and the responsibility of mainstream workforce
systems to prioritize veterans for services and to collaborate with
homeless veteran service providers and veterans service organizations.
Finally, we recommend that the Committee urge the Secretary to
compel state workforce agencies to increase their outstationing of
disabled veterans outreach program specialists and local veterans
employment representatives in locations where homeless veterans
congregate, including grantees under the homeless provider grant and
per diem program and the homeless veterans reintegration program.
TRANSITION ASSISTANCE PROGRAM
Individuals leaving the military are at high risk of homelessness
due to a lack of job skills transferable to the civilian sector,
disrupted or dissolved family and social support networks, and other
risk factors that preceded their military service. Separating service
members must be made aware of the factors that contribute to
homelessness and receive information about sources of preventive
assistance before they exit the military. The Transition Assistance
Program (TAP) has been established to ease the transition of separating
service members to the civilian sector. We are concerned that the TAP
curriculum, which is developed and administered by the Department of
Labor, does not currently include a component on homelessness.
We urge the Committee, through report language, to instruct the
Secretary of Labor to ensure that a module on homelessness prevention
be added to the TAP curriculum. The module should include a
presentation on risk factors for homelessness, a self-assessment of
risk factors, and contact information for preventative assistance
associated with homelessness.
CONCLUSION
The National Coalition for Homeless Veterans appreciates the
opportunity to submit recommendations to Congress regarding the
resources and activities of the U.S. Department of Labor. We look
forward to continuing to work with the Appropriations Committee in
ensuring that our federal government does everything within its grasp
to prevent and end homelessness among our nation's veterans. They have
served our nation well. It is beyond time for us to repay the debt.
______
Prepared Statement of the National Association of Home Builders
On behalf of the over 215,000 members of the National Association
of Home Builders (NAHB), as well as our workforce development arm, the
Home Builders Institute (HBI), we thank you for the opportunity to
submit this statement for the record on the Responsible Reintegration
of Youth Offenders program, as well as the newly-proposed Prisoner Re-
entry Initiative.
NAHB members are involved in home building, remodeling, multifamily
construction, property management, subcontracting, design, housing
finance, building product manufacturing and other aspects of
residential and light commercial construction. Known as ``the voice of
the housing industry,'' NAHB is affiliated with more than 800 state and
local home builder associations around the country. NAHB's builder
members will construct about 80 percent of the more than 1.6 million
new housing units projected for 2004, making housing one of the largest
engines of economic growth in the country.
One of the most pressing problems confronting our industry has been
a shortage of skilled workers. Record numbers in the construction of
new homes, retirements and lackluster interest in the construction
trades by younger generations, compounded by insufficient training
opportunities for those interested in construction, are among the many
factors contributing to the shortages. According to the Bureau of Labor
Statistics, some 240,000 workers are needed each year to meet the
nation's demand for housing.
HOME BUILDERS INSTITUTE (HBI) PROGRAM BACKGROUND
Each year, the Home Builders Institute (HBI) works through various
programs to train and place several hundred youth in residential
construction jobs. Through real-life, hands-on training, some of our
nation's most at-risk youth learn a skill, and a second chance at a
productive and successful life and career. Since 1994, HBI has focused
a significant portion of its effort and resources on one particular
targeted population, adjudicated youth, through its Project CRAFT
(Community Restitution Apprenticeship-Focused Training) program.
Project CRAFT is targeted solely to adjudicated youth and was piloted
in 1994 through a Department of Labor demonstration grant. This program
has successfully combined employers, the juvenile justice system,
workforce development and other systems, in one overall approach, and
has been implemented at 12 sites in nine states (Colorado, Ohio,
Florida, Maryland, New Jersey, North Dakota, South Carolina, Tennessee,
and Texas). Funding for HBI's work on this program has come largely
through funds provided under the Responsible Reintegration of Youth
Offenders budget line.
Project CRAFT incorporates the apprenticeship concept of hands-on
training and academic instruction, utilizing its Pre-Apprenticeship
Certificate Training (PACT), numeracy, literacy and employability
skills curricula. Under the supervision of journey-level trade
instructors, students learn residential construction skills while
completing community service construction projects. More than 90
percent of Project CRAFT graduates achieve success through industry
jobs each year. Since 1994, Project CRAFT has helped more than 2,000
high-risk youth, and in addition to offering adjudicated youth trade
skills and job placement, community service projects by students saved
taxpayers more than $225,000 in labor costs alone in 2002-2003. During
2002, Project CRAFT graduates were placed in jobs with an average wage
of $8.29/hour, and performed over 28,000 hours of community service.
Recidivism rates for Project CRAFT have averaged between 10-15 percent,
with the Nashville, Tennessee program and Orlando, Florida programs
experiencing impressive recidivism rates of 9 percent and 6 percent
respectively. Additionally, students in the program tend to evidence
one grade level of improvement in math and language skills attributable
largely to the formal education component that includes contextual
learning. Math and communication skills are continually reinforced as
students are challenged to apply these skills to everyday situations in
the field and in the classroom.
Project CRAFT efforts were recognized by the Department of Labor
and the National Youth Employment Coalition when in September 2002, the
program received a PEPNet (Promising and Effective Practices Network)
Award. We are also grateful to the Senate Subcommittee on Labor, Health
and Human Services and Education for its acknowledgement of Project
CRAFT in fiscal year 2004 Report Language, and its years of dedicated
support for the Responsible Reintegration of Youth Offenders program.
RESPONSIBLE REINTEGRATION OF YOUTH OFFENDERS PROGRAM
NAHB and HBI's encouraging experience with Project CRAFT is an
example of the enormous success of the Responsible Reintegration of
Youth Offenders pilot program, and the reason why we very strongly
support the continuation of funding for a youth-focused program
targeting adjudicated youth with training that provides this at-risk
population with important job- and life-skills. The Responsible
Reintegration of Youth Offenders Program has helped to bring together
industry and government in a partnership with tangible positive
outcomes. Since 1994 the program has earned a reputation as a
worthwhile investment of taxpayer dollars, a significant and important
resource to the nation's building industry, and a major contributor to
the future success of hundreds of young people. It is a demonstration
model that works, and as such deserves to be touted and replicated. We
hope that its proven success and recognition as a model intervention
will help enable it to receive continued funding.
PRISONER RE-ENTRY PROGRAM
In its fiscal year 2005 budget proposal, the White House introduced
a new program called the ``Prisoner Re-entry Initiative,'' with a
stated focus to ``support activities to help individuals exiting prison
make a successful transition to community life and long-term
employment.'' (See fiscal year 2005 Budget Appendix, page 706) This
program appears to have a focus only on adult offenders, and the budget
does not clearly state whether youth-focused programs would be eligible
to participate in the Prisoner Re-entry Program.
NAHB and HBI support goals of the Prisoner Re-entry program, and
agree that there is undoubtedly enormous potential for successful
programming targeting adult offenders. However, we also strongly
believe that it would be short-sighted policy to exclude adjudicated
youth from the Department's workforce development efforts, and ill-
advised to bring its notable successes such as Project CRAFT to an end.
We believe that any funding targeted to training those who are re-
entering society must include a component targeted to the youth
offender population. We believe that the Prisoner Re-entry program, as
laid out by the Department of Labor, has failed to clarify whether
youth and youth-focused programs would be eligible for participation in
the new program.
As we have stated, the president's newly proposed Prisoner Re-entry
program has significant potential for helping the adult offender
community receive important training and job skills. And we believe
that HBI is well-positioned to participate in an adult-focused program
through its Project TRADE (Training, Restitution, Apprenticeship,
Development and Education) program--which is the sister program to the
youth-focused Project CRAFT. Designed to train and place adult
offenders in employment in the home building industry, TRADE is
currently being implemented in Colorado Springs. Project TRADE has
trained over 500 adult offenders in the residential construction trade
since 1995 through programs in Maryland, North Carolina, Oregon,
Pennsylvania, Virginia, Washington, Tennessee and Colorado. We believe
that Project TRADE's emphasis on adult offenders complements the work
done by Project CRAFT's emphasis on youth offenders.
CONCLUSION
NAHB and HBI continue to strongly support the goals of the
Responsible Reintegration of Youth Offenders program. We also support
the Department of Labor's interest in targeting a program to adult
offenders. However, we are concerned that the Department of Labor has
not clearly laid out which populations would be served by the new
program. Our own effort to secure from DOL a definitive understanding
of the eligible populations has resulted in differing opinions and
further confusion over the program's goals and targets. We believe that
the Responsible Reintegration of Youth Offenders demonstration program
has been highly successful, as evidenced by our own success with
Project CRAFT, and we fervently hope that any proposal supported by
congressional appropriators will take into account the needs of both
the youth and adult ex-offender populations, and will clearly lay out
congressional intent to continue serving the youth ex-offender
population. We believe it would be an error to overlook the tremendous
success achieved by the Responsible Reintegration of Youth Offenders
program, and while we hope that such a move is not the intent of the
Department of Labor, we urge appropriators to clarify the goals of the
Prisoner Re-entry program, and to continue supporting those programs
that target adjudicated youth.
Again, we thank the subcommittee for this opportunity to share our
views on the Responsible Reintegration of Youth Offenders program, and
Prisoner Re-entry Initiative, and look forward to working with you to
promote training programs that help America's at-risk youth acquire the
skills they need for successful and productive careers.
______
Prepared Statement of the Southern California Elderly Nutrition
Partnership
Chairman Specter, Ranking Member Harkin, Members of the
Subcommittee: The Southern California Elderly Nutrition Partnership
(SOCALENP) is submitting this written testimony in support of a 5
percent increase in funding for the Older Americans Act Nutrition
Programs as part of the fiscal year 2005 appropriations bill for the
Departments of Labor and Health and Human Services.
SOCALENP is a regional partnership formed by six major providers of
elderly services in southern California, which serve nearly 2,500,000
meals annually to 80,000 seniors. We are funded by a grant from the
Altria Corporation. We came together to strengthen our advocacy voice
not only on behalf of the seniors we serve in Southern California but
also for all seniors who benefit from the Older Americans Act nutrition
programs. It is important to note that these programs are more than a
meal. They provide an essential link between seniors and their
communities.
California has not only the highest population in the nation but
also the largest number of older citizens of any state. For example,
California has 10 percent of all persons in the United States over the
age of 65. California serves the second highest number of both
congregate and home delivered meals of any state in the nation.
The President's budget for fiscal year 2005, while providing a $3
million increase for the nutrition programs, represents only a .2
percent increase from fiscal year 2004. This means that funding did not
even come close to keeping up with inflation. In fact, this is a
chronic problem facing the nutrition programs. Whereas inflation has
increased by more than 45 percent since 1990, funding for the elderly
nutrition programs has increased by only 23.8 percent with an
especially woeful 9 percent increase for the congregate nutrition
program in that time.
Furthermore, data for fiscal year 2002 indicates that the programs,
while serving more seniors, are serving them fewer meals. This defeats
a primary purpose of the program, which is to be able to provide these
seniors with one third or more of their RDA's through the program. Data
provided by AARP indicates that without any adjustment in the
President's budget just over 5 million congregate and home delivered
meals nationwide would have to be eliminated in fiscal year 2005. Since
the underlying Older Americans Act calls for services to be targeted to
the elderly especially those with the greatest economic need, the loss
of a meal for this sector of seniors is far more devastating.
We seek this modest increase primarily to ensure that we and other
service providers can maintain our commitments to eligible seniors and
avoid adding to waiting lists either in the congregate or home
delivered meals program.
Each member of this Subcommittee knows of Older Americans Act
nutrition programs operating in their state. They probably have taken
time to visit one of the sites where meals are served, which we are
sure left a lasting memory of the need for these services. This program
has enjoyed tremendous success over more than 30 years. It is a value-
added proposition providing essential services to seniors and doing so
in an efficient and localized manner. These highly leveraged federal
dollars are invested in maintaining the nutritional health and
independence of our nation's seniors, which helps to reduce
institutionalization, shorten hospital stays, and allow seniors to
remain active in their communities.
We hope you can commit the necessary $30 million to allow this 5
percent increase to be achieved in fiscal year 2005. We believe our
request is modest and fiscally responsible when one considers the
return on these funds both in terms of its preventive value to the
seniors and the ability of service provider to leverage other support
for the programs. These programs are truly more than a meal.
______
Prepared Statement of the Association for Professionals in Infection
Control and Epidemiology
Thank you for this opportunity to submit testimony on behalf of the
Association for Professionals in Infection Control and Epidemiology
(APIC).
All of us will at some point be admitted to a hospital--or will
visit our loved ones while they receive care at a health care facility.
Our hospitals, the very institutions we depend upon to save our lives,
are fighting for their survival. In recent years, only the highest risk
patients are admitted--those individuals that require the highest level
of care. Unfortunately, many facilities are facing severe nursing
shortages; we have patients waiting for days in Emergency Departments .
. . not for lack of beds, but for lack of personnel to staff the beds.
At the very same time, we are being asked to prepare for the
unthinkable--not just natural disasters but intentional terrorist acts
against our citizens. As a partner in public health preparedness, we
are dedicating resources to create the capacity to respond effectively.
At the very time we are working with our public health partners at the
local, state and federal levels, we are also being asked--or rather,
required--to use our extremely limited and precious resources to meet
unproven, unnecessary regulatory mandates. The most flagrant, and one
that we thought we had proven had no scientific merit is the recent
decision by the Administrator of the Occupational Safety and Health
Administration (OSHA) to enforce the General Industry Respiratory
Protection Standard (or GIRPS) for potential exposures to patients with
Mycobacterium tuberculosis (MTB).
On December 31, 2003, New Years Eve, Assistant Secretary Henshaw
placed two notices in the Federal Register. The first notice stated
that due to the fact that TB is at the lowest incidence level in
recorded history, thanks to CDC guidelines and public health efforts,
OSHA was withdrawing the proposed rule for preventing occupational
exposure to tuberculosis. We commended the agency for this decision.
The second notice stated, however, that OSHA intended to apply the
General Industry Respiratory Protection Standard to exposure to
patients with potentially infectious M. tuberculosis.
OSHA altered its normal course of rulemaking by effecting
significant regulatory changes without providing any opportunity for
public review and comment. This decision was not necessary, nor was it
precipitated by any preexisting requirement. It appears to have been
done completely at the discretion of the OSHA Administrator.
It has never been understood or assumed by the health care
community that the General Industry Respiratory Protection Standard
would apply to exposure to patients with potentially infectious TB. In
fact, when the GIRPS was revised in 1998, the language in the standard
specifically stated that these requirements did not apply to health
care or to exposure to TB. The health care community therefore relied
upon the proposed TB rulemaking for public comment regarding
respiratory protection, instead of commenting on the revision of the
GIRPS.
Assistant Secretary Henshaw contends that he cannot reopen a final
rule for comment, as we are requesting. It is our understanding that
the OSHA Administrator can, at any time, choose to reopen a rule for
further consideration, regardless of whether that rule is proposed or
final. In fact, Secretary Henshaw chose to open the rule on December
31, 2003, by announcing his decision to include exposure to TB under
this regulation. It therefore stands to reason that he can open the
rule again, to allow for public review and comment, as is the normal
course of action.
APIC respectfully requests that OSHA delay application and
enforcement of this standard for occupational exposure to patients with
potentially infectious TB until at least January 2005, and meanwhile
pursue avenues to open the rule for public review and comment. It is
vital that OSHA ensure that its decisions are based on sound scientific
evidence, and allow for the affected parties to voice their concerns
about the implications of these actions. We hope the Subcommittee will
assist us by confronting OSHA on this decision, and require the agency
to reopen the rule for adequate public consideration and comment.
We thank you for this opportunity to provide testimony to the
Subcommittee.
______
Prepared Statement of the Mexican-American Opportunity Foundation and
the Career Services Center, Kern County, CA
In Jalisco, Mexico in the year 1976, Roberto and Maria Sanchez had
a little girl they named Maria. When I was 4 years old my dad brought
our family of twelve to the USA where they worked as farmworkers to
support us while my oldest brother took care of us. A year later I
started kindergarten. I remember my first day. My sister took me to
school. I grabbed her leg because I didn't want to stay. I attended
Carl Clemens Elementary School, then Thomas Jefferson Junior High
School for 3 years. I graduated from there in 1991 and went on to Wasco
Union High School where I graduated in 1995.
Three days after I graduated, I married Francisco Yerena. I
thought, now with my new name, life will be different. In 1999, I gave
birth to a boy. I named him Francisco. Everything seemed perfect. Being
a young couple it was hard financially. My husband struggled as a
seasonal farm worker trying to provide for us. I tried to attend
Bakersfield College, but due to financial hardship, I had to quit
school and get a job. I remember when I had my first job at Richland
pre-school as a substitute teacher's aide and my husband left for
Mexico to see about his papers. This made it harder for me and my son
to survive. I knew something had to change.
I decided to go to the Career Services Center to get a better job.
I went to my appointment and they gave me a basic skills test. Dinorah
Castro of Employers' Training Resource called me back about a work
experience program at the Mexican-American Opportunity Foundation
training center. I worked there as a receptionist for four months.
During these four months it was hard on us financially. I traveled
everyday from Wasco to Bakersfield. At the end of my work day, I picked
up my son from the babysitter and by the time I got home, it was very
late. I fixed dinner and spent what time I had with my son. My husband
finally returned after being gone for eight months and he had to find
employment which only took him a couple of days.
I was so happy that the Mexican-American Opportunity Foundation's
Administrator, Magda Menendez, referred me to the Mexican-American
Opportunity Foundation pre-school for an interview. It was very
exciting for me and I was so nervous waiting to hear from them. On
February 9, 2004, they hired me as a substitute teacher and while I am
working full time, I also attend Bakersfield College so I can get my
teaching degree.
______
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prepared Statement of the Blue Cross and Blue Shield Association
The Blue Cross and Blue Shield Association (BCBSA), which
represents 41 independent, locally operated Blue Cross and Blue Shield
Plans throughout the nation, is pleased to submit written testimony to
the subcommittee on fiscal year 2005 funding for Medicare contractors.
Blue Cross and Blue Shield Plans play a leading role in
administering the Medicare program. Many Plans contract with the
federal government to run much of the daily work of paying Medicare
claims accurately and timely. Blue Cross and Blue Shield Plans serve as
Part A Fiscal Intermediaries (FIs) and/or Part B carriers and
collectively process most Medicare claims.
This testimony focuses on three areas:
I. Background, including a description of Medicare contractor
functions;
II. Current financial challenges facing Medicare contractors; and
III. BCBSA recommendations for Medicare contractor fiscal year 2005
funding.
I. BACKGROUND
Blue Cross and Blue Shield Medicare contractors are proud of their
role as Medicare administrators. While workloads have soared, operating
costs--on a unit cost basis--have declined about two-thirds from 1975
to 2004. In fact, contractors' administrative costs represent less than
1 percent of total Medicare benefits.
Medicare contractors have four major areas of responsibility:
1. Paying Claims.--Medicare contractors process all the bills for
the traditional Medicare fee-for-service program. In fiscal year 2005,
it is estimated that contractors will process over 1.1 billion claims,
nearly 4 million every working day.
2. Providing Beneficiary and Provider Customer Services.--
Contractors are the main points of routine contact with Medicare for
both beneficiaries and providers. Contractors educate beneficiaries and
providers about Medicare and respond to over 50 million inquiries
annually.
3. Handling Hearings and Appeals.--Beneficiaries and providers are
entitled by law to appeal the initial payment determination made by
carriers and FIs. These contractors handle nearly 8 million annual
hearings and appeals.
4. Special Initiatives to Fight Medicare Fraud, Waste, and Abuse.--
All contractors have separate fraud and abuse departments dedicated to
assuring that Medicare payments are made properly. Few government
expenditures produce the documented, tangible savings of taxpayers'
dollars generated by Medicare anti-fraud and abuse activities. For
every $1 spent fighting fraud and abuse, Medicare contractors save the
government $14.
II. CURRENT FINANCIAL CHALLENGES
Of utmost importance to attaining outstanding performance is an
adequate budget. Medicare contractors have been underfunded since the
early 1990's, however, and the largest portion of the contractor
budget--Medicare operations--faces particularly severe funding
pressures. Medicare operations activities include claims processing,
beneficiary and provider education and communications, hearings and
appeals of claims initially denied, and systems maintenance and
security.
The underfunding of CMS and its Medicare contractors has gotten
even more acute since the passage of the Health Insurance Portability
and Accountability Act (HIPAA) and other legislation that places new
responsibilities on contractors, without sufficient resources to
perform those duties. For example, between 1992 and 2002, Medicare
benefits outlays increased 97 percent; claims volume increased 50
percent; yet Medicare operations funding increased a mere 26 percent.
Contractor staffing only increased by 6 percent during this time even
though many new responsibilities were added and claims volume continued
to rise. Clearly funding has not kept pace with additional work. In
addition, the recently enacted Medicare reform legislation includes
significant changes that will require additional resources for
contractors to implement.
Whenever possible, contractors respond to reduced funding by
achieving significant efficiencies in claims processing, but it is not
enough to keep pace with rising Medicare claims volume and diminishing
funding levels. It should be noted that contractors are already
extremely efficient. Currently, contractors' administrative costs
represent less than 1 percent of total Medicare benefits.
Inadequate budgets for Medicare operations also impact Medicare's
fight against fraud and abuse. While many think of Medicare operations
activities as simply paying claims, these activities are Medicare's
first line of defense against fraud and abuse and are critically linked
to activities under the separately-funded Medicare Integrity Program
(MIP). As an example, many of the front-end computer edits (e.g.,
preventing duplicate payments and detecting inaccurately coded claims
or claims requiring additional screening) are funded through Medicare
operations.
Inadequate funding impacts different functions at different times,
but always disrupts the integration of all the functional components
needed to ``get things right the first time.'' It thus results in
inefficiency and higher costs.
III. BCBSA FISCAL YEAR 2005 FUNDING RECOMMENDATIONS FOR MEDICARE
CONTRACTORS
BCBSA is pleased that many Members of this subcommittee recognize
the need for adequate administrative resources at CMS. We are concerned
the Administration's fiscal year 2005 budget does not appropriately
reflect the expected costs to cover Medicare contractor workloads and
it relies on a proposal for $205 million in new user fees from
providers. BCBSA urges Congress to take the following steps to allow
Medicare contractors to meet increased workloads as well as beneficiary
and provider needs:
A. Increase Medicare Contractor Operations Funding to $1.81 Billion for
Fiscal Year 2005
Medicare contractors continue to face increases in Medicare claims
volume. Further reductions in administrative costs, as proposed in the
President's budget, would seriously jeopardize contractors' ability to
administer Medicare. BCBSA recommends:
1. Claims processing funding must be maintained
The President's budget would decrease Part B claims processing
costs by $0.02 per claim to $0.63 under the assumption that
standardized electronic transactions under HIPAA will provide savings.
Part A claims payment remains the same at $0.87. Available contractor
data through the first quarter of fiscal year 2004 show the HIPAA
transactions rule has not resulted in lower claims processing costs. In
fact the average cost for contractors to process a Part B claim is
$0.73, and over $1 for a Part A claim. Medicare electronic claims
submission rates were already high prior to HIPAA implementation--98
percent of Medicare Part A and 84 percent of Medicare Part B. The
current unit costs for processing Medicare Part B claims must be
maintained in fiscal year 2005, requiring an additional $15.4 million.
2. Appeals funding must be enhanced
The President's budget provides no increase to handle ongoing
appeals, even though CMS projects the appeals volume will rise in
fiscal year 2005. Adequate funding is imperative for contractors to
sufficiently handle the nearly 8 million appeals that providers and
beneficiaries are expected to submit. BCBSA recommends an additional
$5.5 million for these important activities.
B. Increase Medicare Integrity Program (MIP) Funding to $740 Million
Congress created Medicare Integrity Program (MIP) under HIPAA to
provide a permanent, stable funding authority for the portion of the
Medicare contractor budget that is explicitly designated as fraud and
abuse detection activities. Funding was capped at $720 million for
fiscal year 2003 and subsequent years, however, despite continuing
increases in claims volume (15 percent increase in claims is projected
in fiscal years 2004-2005). This freeze in funding concurrent with
increases in workload seriously erodes contractors' ability to fight
fraud and abuse and ensure the accuracy and appropriateness of Medicare
payments.
Contractors' enhanced anti-fraud and abuse efforts due to MIP
funding have contributed to the significant decline in improper claims
and deficient documentation submitted by providers. In addition, MIP
saves money. HHS data shows a $14:1 return on the investment.
1. MIP Funding Should Be Increased
BCBSA urges Congress to authorize an immediate increase in the MIP
appropriation to $740 million for fiscal year 2005, with provision for
automatic increases in future years. Medicare contractors need these
resources to effectively combat Medicare waste, fraud and abuse and to
keep pace with rising workloads. MIP contributes to the decline in
improper claims submissions and it saves Medicare money. HHS data show
a $14:1 return on the investment.
C. Reject New User Fees
BCBSA is very concerned that once again CMS recommends new user
fees of $205 million from doctors, hospitals and other providers to
support contractor operations. History has shown user fees to be an
unpredictable stream of funding. In order for contractors to maintain
performance, funds must be consistent and reliable.
Congress has consistently rejected user fees similar to those
recommended in the President's budget. Congress should reject them
again and provide $1.81 billion in appropriated funds for Medicare
contractors and $740 million for MIP.
MEDICARE CONTRACTOR BUDGET
[In millions of dollars]
----------------------------------------------------------------------------------------------------------------
Fiscal year
-------------------------------------------------
2005
2004 administration 2005 BCBSA
recommendation recommendation
----------------------------------------------------------------------------------------------------------------
Medicare Operations........................................... 1,701 1,704 1,814.7
Medicare Integrity Program.................................... 720 720 740.0
-------------------------------------------------
Total Contractor Budget................................. 2,421 2,514 2,555.0
----------------------------------------------------------------------------------------------------------------
______
Prepared Statement of the American Diabetes Association
Thank you for the opportunity to submit testimony on the important
issue of funding the diabetes program at the Centers for Disease
Control and Prevention (CDC) and diabetes research at the National
Institutes of Health (NIH). Our government needs to significantly
increase diabetes funding at these agencies not only for the 18 million
Americans who currently have diabetes, but also for the 40 million who
are at high risk for developing diabetes in the immediate future.
The Association is aware that the Subcommittee is in a particularly
difficult economic position this year. For that reason, the Association
is asking the Subcommittee to adopt one request that is feasible even
under the proposed budget numbers: the American Diabetes Association
strongly urges the Subcommittee to add an additional $10 million to the
budget of the Division of Diabetes Translation at CDC.
Diabetes is a serious disease, and is a contributing and underlying
cause of many of the diseases on which the federal government spends
the most health care dollars. Diabetes is a significant cause of heart
disease (which costs our nation $183.1 billion each year), a
significant cause of stroke ($43.3 billion each year), the leading
cause of kidney disease ($40.3 billion). Diabetes is also the leading
cause of adult-onset blindness and lower limb amputations.
Additionally, aside from all of these related conditions, diabetes
alone costs our nation $132 billion a year.
Approximately 42,000 people suffering from diabetes live in each
congressional district. The following illustrates how diabetes affects
your district in realistic terms:
--177 of your constituents will develop heart disease this year
because of diabetes.
--154 of your constituents will develop end stage renal disease this
year because of diabetes.
--129 of your constituents will lose a foot or leg this year because
of diabetes.
--55 of your constituents will go blind this year because of
diabetes.
Given the systemic damage diabetes imposes throughout the body, it
is no surprise that the life expectancy of a person with the disease
averages 10-15 years less than that of the general population.
Unfortunately, the spread of diabetes will only get worse in the
coming years unless we see a significantly larger funding commitment by
the federal government. Indeed, a CDC report issued in January of this
year finds that the prevalence of diabetes nationwide increased by over
60 percent between 1990 and 2001. If diabetes keeps increasing at this
rate, its prevalence will double in just over 15 years.
The Association hopes that an additional $10 million this year for
the Division of Diabetes Translation--a request strongly supported by
the Congressional Diabetes Caucus, comprised of 280 Members of
Congress--would simply be the first step in a 5-year effort to double
to budget of the Division. Although the medical research community has
made tremendous strides in the area of diabetes over the past two
decades, the benefits of this research have not been fully realized by
a majority of the Americans affected by this disease. The federal
government must commit more resources to ensure that important research
findings are effectively and adequately translated into public health
interventions. To this end, we believe strongly in the work funded by
the Division of Diabetes Translation.
However, the Division's fiscal year 2004 budget of $67 million--and
the President's $67 million request for fiscal year 2005--represents a
miniscule commitment to diabetes prevention and control. Indeed, for
every $1 that diabetes costs this country, the federal government
currently invests less than $.01 to help Americans prevent and manage
this deadly disease.
In 2003 the Division provided support for more than 50 state- and
territorial-based diabetes control programs to reduce the complications
associated with diabetes. However, funding constraints required the
Division to provide severely limited support to 26 states, 8
territories, and D.C. for capacity-building diabetes programs. Slightly
more substantive support was provided to the other 24 states for basic
implementation programs. Although every state and territory has at
least a capacity-building program, unfortunately these programs do not
even come close to addressing the needs statewide. Instead, they simply
serve as a rudimentary framework upon which a more comprehensive
program can be built.
CDC also conducts other activities to help people currently living
with diabetes. For example, CDC works with NIH to jointly sponsor the
National Diabetes Education Program (NDEP), which seeks to improve the
treatment and outcomes of people with diabetes, promote early
detection, and prevent the onset of diabetes. In addition, CDC funds
work at the National Diabetes Laboratory to support scientific studies
that will improve the lives of people with diabetes.
Even while the Division of Diabetes Translation conducts a number
of activities to help people with diabetes, it suffers a similar
problem as its NIH counterpart, NIDDK. Compared to other diseases,
diabetes remains significantly underfunded at CDC. If adequately
funded, the Division would be able to fund a basic implementation
program in every state as well as conduct and fund additional projects
to assist people with diabetes. Without fully-funded diabetes programs
and projects in all parts of the country, it will be exceedingly
difficult--if not impossible--to control the escalating costs
associated with diabetic complications and to stem the epidemic rise in
diabetes rates.
The American Diabetes Association supports the President's support
for the Steps to a Healthier U.S. Initiative, and is encouraged that
this program focuses--among other things--on obesity and diabetes. We
strongly believe, though, that funds made available for this new
Initiative should not take away from funds that would otherwise be made
available to the Division of Diabetes Translation. State Diabetes
Prevention and Control Programs--when provided with enough funding--are
proven commodities that have been extremely successful in helping
Americans prevent and manage their diabetes. Americans in every state
should have access to such quality programs.
Chronic diseases, including diabetes, account for nearly 70 percent
of all health care costs as well as 70 percent of all deaths annually.
However, less than $1.25 per person is directed toward public health
interventions focused on preventing the debilitating effects associated
with chronic diseases, demonstrating that federal investment in chronic
disease prevention remains grossly inadequate. We cannot ignore those
Americans who are currently living with diabetes and other diseases.
RECENT FUNDING INCREASES
The American Diabetes Association appreciates that Congress has
begun to give greater attention to diabetes research at NIH in recent
years and that the current Administration has proposed an overall
increase in the NIH budget. However, during much of the past decade,
diabetes funding has stagnated even while the burden has grown
significantly. Indeed, from 1987-2001, appropriated diabetes funding as
a share of the overall NIH budget has dropped by more than 20 percent
(from 3.9 percent to 2.9 percent) while the death rate due to diabetes
has increased by more than 40 percent. Thankfully, the past 4 years
have brought larger increases in diabetes funding than we had seen over
the majority of the decade. Only over these years did the growth in
diabetes research funding finally keep pace with the growth of the
overall NIH budget. At a time when diabetes is exploding across our
nation, it remains essential that we increase the research funding
levels for diabetes.
Mr. Chairman, we appreciate the increases of the last few years.
Congress should be proud of the bi-partisan support for the effort to
double the NIH budget. But this should not equate to an automatic
institute-by-institute doubling.
Some institute budgets are larger not only due to scientific
opportunities, but due to special consideration in years past.
Unfortunately, across-the-board percentage increases make it difficult,
if not impossible, to address funding shortfalls for diseases that now
have promising scientific opportunities. Diseases like diabetes that
have not received funding commensurate with their national burden, as
well as with existing scientific opportunities, continue to fall behind
as a result of this funding strategy.
Across-the-board increases for all institutes simply do not allow
the Congress, or the nation, to deal with the serious problem of
diabetes anytime soon. While on the surface across-the-board increases
appear equitable to everyone, it actually perpetuates inequity in
absolute dollar terms. In reality, a 15 percent increase means much
more for diseases and institutes with large budgets, and far less for
diseases and institutes with small budgets.
Continuing with an across-the-board approach for Institute funding
means that these discrepancies in funding will continue to grow. This
is not inherently bad so long as the difference accurately reflects the
scientific opportunities and health impact of disease on the nation.
But in the case of diabetes at least, it does not.
The net effect of an across-the-board approach is that past funding
legacies still affect the funding priorities at NIH to this day. By not
constantly making an honest assessment of the health challenges faced
by our nation and by not looking harder at the scientific opportunities
facing the research community, NIH has perpetuated an inequality in
funding based on decisions made many years before.
CONCLUSION
I firmly believe that we could rapidly move toward curing,
preventing, and managing this disease by increasing funding for
diabetes programs and research both at CDC and NIH. Your leadership can
help accomplish this goal.
The American Diabetes Association strongly urges the committee and
Congress increase the budget of the Division of Diabetes Translation by
$10 million in fiscal year 2005 as the first step in a 5-year doubling
plan. A doubling of the Division's budget would allow the Division to
finally implement a Basic Implementation Diabetes Prevention and
Control Program in every state and territory, thus moving the
government in the direction of truly helping all Americans with
diabetes. Additionally, we urge the Subcommittee to increase funding at
NIH for diabetes research as much as possible in these strict economic
times.
Speaking on behalf of the 18 million Americans with diabetes--a
disease that crosses gender, race, ethnicity and political party; a
disease that is among the most costly, debilitating, deadly and
prevalent in our nation; and a disease that is exploding throughout our
nation--I appreciate the opportunity to submit this testimony. The
American Diabetes Association is prepared to answer any questions you
might have on these important issues.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM), the largest single
life science society with 43,000 members, is pleased to submit
testimony on the fiscal year 2005 budget for the Centers for Disease
Control and Prevention (CDC). The CDC is the nation's lead agency for
protecting the health and safety of the public, both nationally and
globally. Threats to public health and security have steadily increased
in number and complexity over time, despite medical successes and
technical innovation. The work of the CDC is of unprecedented
importance in safeguarding public health.
The ASM is concerned that funding for CDC is not keeping pace with
its growing responsibilities to address new health threats. The $6.9
billion fiscal year 2005 request for the CDC is a 2.8 percent reduction
below last year's $7.1 billion. The ASM endorses the CDC Coalition's
recommendation of $8.1 billion in fiscal year 2005 for CDC, followed by
annual increases to achieve $15 billion for the agency by fiscal year
2008. Increased support is crucial to the CDC's primary goals for
protecting public health: surveillance and response, basic and applied
research, training and education, and prevention and control.
The CDC's ability to mobilize rapidly to prevent or contain disease
is an urgently needed line of defense against the economic and social
havoc that can result from public health threats. In 2003, the CDC was
essential in identifying the cause of the Severe Acute Respiratory
Syndrome (SARS) epidemic in Asia and the first case of human monkeypox
in the United States. Agency personnel also trained approximately 8,800
U.S. clinical laboratory staff in terrorism preparedness and response,
while others investigated numerous outbreaks of infectious and food-
borne diseases, as well as chronic disease diagnoses among diverse
populations. Proposed cuts to a number of CDC programs could jeopardize
the agency's activities to address health threats.
The ASM is concerned that the proposed fiscal year 2005 budget
represents no or only slight increases in CDC programs such as emerging
and re-emerging infectious diseases, antimicrobial resistance and
domestic HIV/AIDS programs. The ASM also recommends that new
bioterrorism preparedness initiatives be funded without redirecting
resources from needed on-going state and local programs, as proposed in
the fiscal year 2005 budget. By adequately enlarging the CDC
appropriation, Congress would strengthen significantly our defenses
against naturally and intentionally caused disease in the United States
and elsewhere.
INFECTIOUS DISEASES AND PUBLIC HEALTH
The National Center for Infectious Diseases (NCID) supports
programs to prevent and control endemic, new and reemerging infectious
diseases in the United States and abroad. The proposed fiscal year 2005
budget for the CDC includes $400.8 million for infectious diseases, an
increase of $31.3 million over fiscal year 2004 funding. Most of the
increase benefits two CDC programs: $27.5 million to expand the CDC's
Global Disease Detection Initiative to $51 million, and $2 million to
increase West Nile virus (WNV) research as well as state and local
health department WNV surveillance and response capabilities. Because
of increased world trade and travel, nations can no longer ignore any
type of infectious disease and global strategies have become
fundamental to CDC's public health activities. The ASM supports the
budgetary increases proposed for these two programs, but is concerned
that critical components of the CDC infectious diseases mission also
need additional resources in the fiscal year 2005 budget.
In 2003 the Institute of Medicine (IOM) released a strongly worded,
cautionary report on Microbial Threats to Health. The IOM report points
out that infectious disease public health needs have been and will
continue to increase. Between 1973 and 2003, more than three dozen
newly emerging diseases were identified. Most recently, hantavirus,
West Nile virus, SARS, bovine spongiform encephalopathy (BSE), and
monkeypox became known enemies to public health in the United States.
In the 1990s, the CDC revitalized its infectious disease programs to
better reflect the emergence of new infectious diseases. By investing
in partnerships with local and state health departments, academic
research and teaching institutions, private industries, other federal
agencies, world health organizations, and health agencies and
researchers in other nations, the CDC expanded its ability to detect
and contain infectious disease, as it intensified its own research and
training programs. The vital need for CDC programs was emphasized
dramatically last year with the SARS epidemic and hundreds of human WNV
infections. The need remains as urgent today with concern about BSE and
avian flu now in the United States.
Experts predict a major pandemic during this century and the most
likely source remains influenza. A hallmark of pandemics and many small
scale emerging infectious diseases is that they are zoonoses. Zoonotic
diseases, infections which are naturally transmitted between animals
and man, represent one of the leading causes of illness and death from
infectious diseases and nearly all emergent episodes of the past 10
years have involved zoonotic infectious agents. In the United States
alone, an influenza pandemic could cause an estimated 89,000 to 207,000
deaths and cost the nation from $71-167 billion in health care costs
and lost productivity. Additional budgetary resources are needed to
address issues such as zoonoses and influenza, which were highlighted
in the IOM report. CDC infectious diseases should be increased by an
additional $50 million.We recognize that significant investment will be
required to enhance efforts to address the threat of pandemic influenza
in order to develop a newer generation influenza vaccine that can be
quickly produced and deployed, to strengthen the public health
infrastructure at the state and local levels, and to ensure needed
vaccines and antiviral medicines are readily available. We recommend
that the Department of Health and Human Services (DHHS) assess the
needs for resources to address pandemic flu within the NIH, CDC and FDA
and coordinate the planning activities.
The goal of the CDC's new Global Disease Detection Initiative
within its epidemic services and infectious disease control programs is
to work faster and better in recognizing and controlling any infectious
disease threatening public health. The CDC operates in a global arena,
establishing myriad programs and collaborations beyond the nation's
borders and sending quick-response assessment teams around the world.
It recently funded five university schools of public health and three
non-government organizations to assist malaria-endemic African
countries, where the disease kills and disables millions. CDC personnel
provide consistent epidemiological expertise and lab support to nations
under siege, most recently the Congo (Marburg virus disease), Uganda
and Gabon (Ebola hemorrhagic fever), Saudi Arabia and Yemen (Rift
Valley fever), and more. CDC programs will be expanded in five
countries including Brazil and China and new sites will be created in
six others, most of them in Africa. The CDC also will continue to be a
major implementing agency for the U.S. Department of State's Mother to
Child HIV Prevention Initiative inaugurated last year. The new Global
Disease Detection initiative includes improvement of the existing
international surveillance network for influenza, to bolster the early
warning system for identifying more uncommon viruses.
The multi-faceted network of disease surveillance in the United
States expands and changes annually. The CDC last year enhanced its
surveillance of prion diseases and responded to the first confirmed
U.S. case of BSE in cattle. Food-borne illness surveillance has grown
into one of the most extensively used networks: 76 million Americans
suffer from contaminated foods each year at an estimated cost of over
$1 billion. The CDC's PulseNet is credited with revolutionizing food-
borne surveillance in this country and overseas; recently it was
expanded to incorporate a total of 21 participating countries. In 2003,
it was critical in identifying U.S. outbreaks of salmonellosis from
tomatoes and eggs, E. coli O157 infection from beef, and listeriosis
from raw milk cheese. The CDC coordinates U.S. influenza surveillance
and recently expanded its sentinel surveillance sites through one of
many data-collecting networks. The 891 influenza sites will not only
alert officials to impending flu epidemics, but also to other
respiratory diseases.
Effective as surveillance networks are in preventing further spread
of disease, protecting the public must stress prevention through
effective education and science-based efforts. For instance, the CDC
supplies funding to most states to promote appropriate use of
antibiotics and thus limit the rising medical costs associated with
antibiotic resistance. The agency has implemented a National Hepatitis
C Prevention Strategy by establishing coordinators in all 50 state
health departments. It developed guidelines for the prevention of
perinatal group B streptococcal disease that have resulted in a 70
percent reduction since 1993. An initiative begun last year expects to
increase HIV testing in this country and enhance prevention, in
recognition that the rate of new infections (about 40,000 each year)
has remained stable despite education efforts over the past two
decades. The ``Advancing HIV Prevention'' approach shifts strategies to
reduce even further the barriers to early HIV diagnosis and quality
medical care.
In response to the 2001 Public Health Action Plan to Combat
Antimicrobial Resistance (AR), the CDC announced a new extramural
applied research grant program in 2003, to fund research in the areas
of mechanisms of dissemination of AR genes, resistance in specific
human pathogens of public health concern and the characterization of
strains of community-associated methicillin-resistant Staphylococcus
aureus (MRSA). The goal of the applied research program is to prevent
and control the emergence and spread of antimicrobial resistance in the
United States. Approximately $25 million is being requested for
antimicrobial resistance research, surveillance, prevention and control
activities. Considering the magnitude of the problem of antimicrobial
resistance, additional new funding should be provided in the CDC budget
to address the alarming issue of antimicrobial resistance.
Each year about 48,000 Americans die from vaccine-preventable
diseases; worldwide, these diseases cause an estimated 2.4 million
childhood deaths. The fiscal year 2005 CDC budget request includes $1.9
billion for a number of significant vaccination programs. Some, like a
stockpile of all routinely recommended childhood vaccines, already are
in progress. Others are new, like an inventory of childhood influenza
vaccine. The immunization budget will continue to provide global
immunization activities ($151 million), including the goal of global
polio eradication by 2005.
NATIONAL SECURITY AND BIODEFENSE
Intentional release of biological weapons troubled the CDC well
before events of 2001, but the enormity of those attacks brought home
the grave potential of bioterrorism. The attacks also forced the CDC to
shift much of its mission focus to bioterrorism preparedness, in
collaborations with other federal, state, and local health
organizations. The agency quickly formed emergency response teams,
established extensive state-of-the-art communication systems, and
concentrated on basic and applied research related to possible
bioweapons. The fiscal year 2005 request of $1.1 billion would continue
CDC efforts related to terrorism preparedness and emergency response at
a funding level identical to that implemented so effectively in fiscal
year 2004. The ASM recognizes the dire consequences of bioterrorism and
supports extensive funding of CDC preparedness programs. However, the
programmatic impact of removing $105 million from state/local programs
and $25 million from internal CDC activities to subsidize CDC's
component in a new cross-agency Biosurveillance initiative deserves
evaluation.
The new Biosurveillance Initiative was designed by a coalition of
federal agencies after the Homeland Security Council identified early
bioattack warning and surveillance as top priority areas in need of
improvement. The CDC's contribution, funded at $130 million in the
proposed fiscal year 2005 budget, includes three new program
activities, the BioSense surveillance system ($100 million), real-time
laboratory reporting ($20 million), and expanded border health
inspection and quarantine capability ($10 million). The BioSense
program represents a new and largely untested generation of infectious
disease surveillance that does not rely upon mandatory or voluntary
case reporting from healthcare providers. Instead, sets of anonymous
health data will be automatically and electronically gathered from pre-
determined sources like over-the-counter retail sales of home health
remedies and visits to emergency rooms. This system is intended to
provide public health officials with ``a near real-time sense'' of the
community's health status and to reduce the time needed to detect
threats from days or weeks to hours.
The ASM strongly supports two programs of the new initiative which
build on the importance of trained personnel who respond locally but
work together within the national goal of preventing bioterrorist
attacks. One program will expand the CDC's existing Laboratory Response
Network (LRN) by adding animal diagnostics and food safety capabilities
to public health, clinical, and private commercial laboratories. The
other program recognizes that every day more than 2 million people
travel to or through this country by air, sea or land, and that each
year, more than 350,000 new immigrants arrive. It adds new,
strategically placed quarantine stations and creates multidisciplinary
teams able to respond to infectious disease emergencies at U.S.
seaports, border crossings, and airports.
By the end of fiscal year 2004, over $3 billion will have been
allocated by the CDC to upgrade state and local health departments
since the 2001 terrorist attacks. Supporting this nationwide community
of anti-terrorism capability extends the CDC's own efforts and provides
a greater return on funding investments. CDC support also comes from
the many wide-ranging communication networks used by the CDC to
disseminate new scientific information, health risk alerts, and
population- or disease-specific updates. An example is the Epidemic
Information Exchange, Epi-X, which provides swift exchange of
information among more than 2,000 key public health officials
nationwide. The Public Health Information Network sends health alerts
and advisory messages to one million recipients, including 90 percent
of all county public health departments. The Laboratory Response
Network, to be expanded under the new Biosurveillance Initiative,
already includes 113 members in the United States and elsewhere; an
increasing number of these labs could confirm the presence of anthrax,
tularemia, and smallpox, and more than half are qualified to handle
some of the most dangerous pathogens.
The complex CDC infrastructure used to prevent bioterrorism also
incorporates the training of specialized personnel, the stockpiling of
crucial supplies needed in mass emergencies, and the careful monitoring
of pathogens and other toxic agents used in research. Management of the
Strategic National Stockpile has been returned to the HHS from the
Department of Homeland Security, as a source of smallpox vaccine and
other medical supplies shippable to any scene of mass trauma in the
United States. The Epidemic Intelligence Service grew from 148 officers
in 2001, to 167 in 2003; 49 of these first-line responders are assigned
to local or state health departments. With the U.S. Department of
Agriculture, this year the CDC will inspect 300 laboratories using
potential bioagents in research, through the Select Agent Program that
controls the possession and transfer of infectious agents. The SAP
program should have adequate resources.
BUILDINGS AND FACILITIES
A total of $81.5 million is proposed in the fiscal year 2005 budget
for CDC buildings and facilities. CDC is undertaking and has made
substantial progress in a 10-year effort to rebuild its physical
infrastructure and replace and upgrade decrepit out-dated buildings and
facilities. State of the art, safe and secure laboratories and
facilities, as well as modern equipment, are essential to an effective
CDC response to the broad range of public health threats facing the
country and the world. The ASM recommends that Congress appropriate
$250 million for CDC's critical infrastructure needs.
______
Prepared Statement of the InterTribal Bison Cooperative
INTRODUCTION AND BACKGROUND
My name is Ervin Carlson, a Tribal Council member of the Blackfeet
Tribe of Montana and President of the InterTribal Bison Cooperative.
Please accept my sincere appreciation for this opportunity to submit
testimony to the honorable members of the Appropriations Subcommittee
on Labor, Health and Human Services and Education. The InterTribal
Bison Cooperative (ITBC) is a Native American non-profit organization,
headquartered in Rapid City, South Dakota, comprised of fifty-three
(53) federally recognized Indian Tribes located within 18 States across
the United States.
Buffalo thrived in abundance on the plains of the United States for
many centuries before they were hunted to near extinction in the 1800s.
During this period of history, buffalo were critical to survival of the
American Indian. Buffalo provided food, shelter, clothing and essential
tools for Indian people and insured continuance of their subsistence
way of life. Naturally, Indian people developed a strong spiritual and
cultural respect for buffalo that has not diminished with the passage
of time.
Numerous tribes that were committed to preserving the sacred
relationship between Indian people and buffalo established the ITBC as
an effort to restore buffalo to Indian lands. ITBC focused upon raising
buffalo on Indian Reservation lands that did not sustain other economic
or agricultural projects. Significant portions of Indian Reservations
consist of poor quality lands for farming or raising livestock.
However, these wholly unproductive Reservation lands were and still are
suitable for buffalo. ITBC began actively restoring buffalo to Indian
lands after receiving funding in 1992 as an initiative of the Bush
Administration.
Upon the successful restoration of buffalo to Indian lands,
opportunities arose for Tribes to utilize buffalo for tribal economic
development efforts. ITBC is now focused on efforts to assure that
tribal buffalo projects are economically sustainable. Federal
appropriations have allowed ITBC to successfully restore buffalo the
tribal lands, thereby preserving the sacred relationship between Indian
people and buffalo. The respect that Indian tribes have maintained for
buffalo has fostered a serious commitment by ITBC member Tribes for
successful buffalo herd development. The successful promotion of
buffalo as a healthy food source will allow Tribes to utilize a
culturally relevant resource as a means to achieve self-sufficiency.
FUNDING REQUEST FOR PREVENTATIVE HEALTH CARE INITIATIVE
The InterTribal Bison Cooperative respectfully requests an
appropriation for fiscal year 2005 in the amount of $3,000,000 in the
form of an earmark to the Department of Health and Human Service
Department's budget. ITBC intends to utilize the funds to conduct a
national demonstration project focused on the delivery of bison meat to
Native Americans suffering from diet related diseases.
The Native American population currently suffers from the highest
rates of Type 2 diabetes. The Indian population further suffers from
high rates of cardio vascular disease and various other diet related
diseases. Studies indicate that Type 2 diabetes commonly emerges when a
population undergoes radical diet changes. Native Americans have been
forced to abandon traditional diets rich in wild game, buffalo and
plants and now have diets similar in composition to average American
diets. More studies are needed on the traditional diets of Native
Americans versus their modern day diets in relation to diabetes rates.
However, based upon the current data available, it is safe to assume
that disease rates of Native Americans are directly impacted by a
genetic inability to effectively metabolize modern foods. More
specifically, it is well accepted that the changing diet of Indians is
a major factor in the diabetes epidemic in Indian Country.
Approximately 65-70 percent of Indians living on Indian
Reservations receive foods provided by the USDA Food Distribution
Program on Indian Reservation (FDPIR) or from the USDA Food Stamp
Program. The FDPIR food package is composed of approximately 58 percent
carbohydrates, 14 percent proteins and 28 percent fats. Studies have
shown that the FDPIR food package has not been compatible with the
genetic compositions of Native Americans and has been a major factor in
the high incidence of diet-related disease among Native Americans.
Indians utilizing Food Stamps generally select a grain based diet and
poorer quality protein sources such as high fat meats based upon
economic reasons and the unavailability of higher quality protein food
sources.
Buffalo meat is low in fat and cholesterol and is compatible to the
genetics of Indian people. ITBC intends to develop a health care
initiative that would educate Indian Reservation families of the
benefits of incorporating buffalo meat into their diets. In conjunction
with educating Reservation families on the benefits of buffalo meat,
ITBC intends to develop methods to make buffalo meat accessible for
Indian families and to promote incorporation of buffalo into their
diets. ITBC intends to coordinate with Reservation health care
providers in nutritional studies of Reservation populations that
incorporate buffalo meat into diet packages.
ITBC believes that incorporating buffalo meat will positively
impact the diets of Indian people living on Reservations. A healthy
diet for Indian people that results in a lower incidence of diabetes
and other diet related illnesses will reduce Indian Reservation health
care costs and result in a savings for taxpayers.
FUNDING REQUEST FOR ITBC TRAINING AND LABOR PROGRAM
The InterTribal Bison Cooperative respectfully requests an
appropriation for fiscal year 2005 in the amount of $500,000. This
amount is $400,000 above the fiscal year 2004 appropriation for ITBC
and is critical to maintain last years funding level and to develop
ITBC's training and labor program.
In fiscal year 2004, the ITBC and its member Tribes were funded at
$100,000, a decrease of $200,000 from the previous year. ITBC is now
requesting $500,000 for fiscal year 2005 for job training as part of
ITBC's labor initiative. To insure the success of ITBC's buffalo
restoration efforts to Indian lands, training for the various jobs
related to the buffalo projects is essential. Most member Tribes of
ITBC have reservation unemployment rates of 72 percent. Jobs
opportunities on most Indian Reservations are limited, low-paying, and
often seasonal and temporary. The jobs created by buffalo restoration
to Indian lands will positively impact Tribal unemployment rates and
the overall Reservation poverty levels. Raising buffalo as an economic
development effort requires skilled labor in permanent employment. ITBC
has developed a job training program incorporating on-the-job training
and work experience for youth that specifically addresses the unique
needs of managing and maintaining buffalo. ITBC's training program
further focuses on strengthening the economic development opportunities
of buffalo restoration with training specific to meat processing,
veterinary science, wildlife and biological services, infrastructure
development, business and management training, and the overall
development of a skilled workforce.
Sufficient funding for job training is critical to the success of
the buffalo restoration projects. The increase in funding will ensure
that ITBC can provide job training, job growth training to ITBC member
tribes. Without funding at the requested level, the buffalo restoration
projects have less assurance of success.
ITBC GOALS AND INITIATIVES
In addition to developing a preventative health care initiative,
ITBC intends to continue with buffalo restoration efforts and the
Tribal buffalo marketing initiative.
In 1991, seven Indian Tribes had small buffalo herds, with a
combined total of 1,500 animals. The herds were not utilized for
economic development but were often maintained as wildlife only. During
ITBC's relatively short 10-year tenure, it has been highly successful
at developing existing buffalo herds and restoring buffalo to Indian
lands that had no buffalo prior to 1991. Today, through the efforts of
ITBC, over 35 Indian Tribes are engaged in raising over 15,000 buffalo.
All buffalo operations are owned and managed by Tribes and many
programs are close to achieving self-sufficiency and profit generation.
ITBC's technical assistance is critical to ensure that the current
Tribal buffalo projects gain self-sufficiency and become profit-
generating. Further, ITBC's assistance is critical to those Tribes
seeking to start a buffalo restoration effort.
Through the efforts of ITBC, a new industry has developed on Indian
reservations utilizing a culturally relevant resource. Hundreds of new
jobs directly and indirectly revolving around the buffalo industry have
been created. Tribal economies have benefited from the thousands of
dollars generated and circulated on Indian Reservations.
ITBC has also been strategizing to overcome marketing obstacles for
Tribally raised buffalo. ITBC is presently assisting the Assiniboine
and Gros Ventre Tribes of the Fort Belknap Reservation, who recently
purchased an USDA approved meat-processing plant, with a coordination
scheme to accommodate the processing of range-fed Tribally raised
buffalo.
CONCLUSION
ITBC has proven highly successful since its establishment to
restore buffalo to Indian Reservation lands to revive and protect the
sacred relationship between buffalo and Indian Tribes. Further, ITBC
has successfully promoted the utilization of a culturally significant
resource for viable economic development.
ITBC has assisted Tribes with the creation of new jobs, on-the-job
training and job growth in the buffalo industry resulting in the
generation of new money for tribal economies. ITBC is also actively
developing strategies for marketing Tribally owned buffalo. Finally,
and most critically for Tribal populations, ITBC is developing a
preventive health care initiative to utilize buffalo meat as a healthy
addition to Tribal family diets to reduce the incidence of diet-related
illnesses.
ITBC strongly urges you to support its request for a $3,000,000
earmark to the Department of Health and Human Service Department's
budget to develop the critically needed preventative health care
initiative utilizing Tribally produced buffalo.
______
Prepared Statement of the Medicare Payment Advisory Commission
The Medicare Payment Advisory Commission (MedPAC) was created by
the Congress to provide it with independent policy advice and technical
assistance concerning the Medicare program and other aspects of the
health care system. To carry out its responsibilities MedPAC requests a
budget appropriation of $9.905 million for fiscal year 2005. This
request for a $605,000 increase over the Commission's fiscal year 2004
appropriation reflects the expanded responsibilities assigned to the
Commission by the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Public Law 108-173), including 16
additional reports and the requirement to advise the Congress on the
new prescription drug benefit. The most significant increases in
MedPAC's fiscal year 2005 budget will fund data analysis and research
contracts to meet those requirements.
WHO WE ARE
MedPAC is a federal advisory commission authorized under section
1805 of the Social Security Act (42 U.S.C. 1395 b-6), as added by
section 4022 of the Balanced Budget Act of 1997 (BBA) (Public Law 105-
33). Broadly defined by statute, the Commission's responsibilities are
to:
--consider Medicare payment policies for private plans and
traditional fee-for-service Medicare,
--determine the effects of Medicare payment policies on the delivery
of health care services, and
--analyze the implications for Medicare of changes in the broader
health care system.
MedPAC is a small efficient operation. The Commission consists of
17 Commissioners, appointed by the Comptroller General of the General
Accounting Office, who possess expertise in biomedical, health
services, and health economics research and who draw on their
experiences as consumers, providers, employers, and payers. The
Commission meets publicly throughout the year as it develops its
recommendations. An executive director, analytic and administrative
personnel staff the Commission. Staff are highly trained health policy
analysts and economists. The Commission has less than 40 staff and
outsources 40 percent of its budget for tasks such as data analysis,
programming, printing, editorial work, and selected research projects
to maintain efficiencies. We have also achieved efficiencies by
migrating data analysis to personal computers and moving from printed
to electronic reports.
The MMA requires that the expertise of the Commission's membership
be expanded to include pharmaceuticals, and we expect that to occur
when new commissioners are appointed in 2004. Over the coming fiscal
year, MedPAC will make a significant investment in resources to be able
to provide advice on the implementation of the prescription drug
benefit and other program changes introduced by the MMA. Judging from
our experience during consideration of the legislation, we also
anticipate a significant use of resources to respond to Congressional
inquiries about the new benefit and program changes.
WHAT WE DO
Each year, our annual appropriations provide the resources
necessary to complete the Commission's required activities, including:
--March report to the Congress. Delivered on March 1 of each year,
this report includes recommendations on the appropriate levels
of payment for Medicare providers and policies to address the
distribution of payments within each payment sector.
--June report to the Congress. Delivered on June 15 of each year,
these reports have addressed issues such as Medicare in rural
America, innovations and variations in the Medicare program,
and a variety of other topics.
--Reports required by other legislation. The new Medicare legislation
requires MedPAC to issues 16 reports on a variety of topics--12
of which are due during fiscal year 2005.
--Comments on administrative actions. MedPAC is required to comment
on payment-related reports that the Secretary submits to the
Congress and other proposed rules issued by the Centers for
Medicare & Medicaid Services (CMS).
To support the Congress, MedPAC also anticipates Congressional
requests for the following projects not specifically mandated by law:
--Policy briefs on topics of interest, including issues such as a
primer on prescription drug formularies, descriptive
information on beneficiaries eligible for both Medicare and
Medicaid, information about employer-sponsored insurance
benefits, and other issues that generate interest throughout
the year.
--A Medicare data chartbook in June 2004, similar to the one produced
in 2003 in response to requests by health committee staff.
--Requests for data and analysis from the health committee staff
(more than 100 last year).
medpac reports provide information and recommendations
MedPAC's fiscal year 2003 reports informed the Congress on wide
range of Medicare issues. During the past year, the Commission
completed our annually mandated March and June reports, eight reports
mandated under the BBRA and BIPA, and other reports and studies as
requested by the Congress. In addition, six reports were developed for
MedPAC by external contractors and issued during 2003, and the
Commission has submitted written comments to the Secretary of the
Department of Health and Human Services on nine proposed rules.
In a program that spends $272 billion, MedPAC's payment update
recommendations have important implications for the beneficiaries, the
medical delivery system, and the federal budget. The March 2004 report
focuses on payment policies and presents recommendations to Congress on
updating payments to hospitals, physicians, and other providers, as
well as refinements to their payment systems. It also includes
refinements to the payments for private plans as well as
recommendations to add quality incentives to the payment systems for
end-stage renal disease patients and private plan enrollees.
The June 2004 report will address a range of issues of importance
to the Congress as it considers both future legislation and CMS
implementation of the MMA. The report will address a broad range of
policy issues, including disease management, the dual eligible
population, information technology, and an overview of issues
surrounding implementation of the new drug benefit. It will also
include analyses of long-term care hospitals, innovations in
purchasing, and hospices.
We anticipate production and submission of a Medicare data
chartbook in June 2004, similar to the one produced in 2003 and as
requested by health committee staff--although publication will depend
upon our assessment of those resources we must commit to studies
mandated by the MMA.
During the rest of fiscal year 2004 and into 2005, MedPAC will also
be working on the 16 studies mandated by the MMA. These reports cover
issues such as the effect of new provisions to aid rural hospitals,
analysis of the volume of physician services, changes in use of Part B
drugs by oncology patients, and beneficiary cost sharing in plans. In
addition, the Institute of Medicine is required to consult with the
Commission on a study about quality incentives in the payment system,
and GAO and CMS will collaborate with us on an analysis of specialty
hospitals.
MedPAC will also comment on CMS administrative actions and review
new payment systems for providers such as long-term care hospitals and
inpatient rehabilitation facilities. The MMA assigned the Secretary
more than 30 reports on which MedPAC will comment. Given the volume of
rules and reports the Secretary must promulgate in the coming year to
implement the new drug benefit and other MMA provisions, we anticipate
that reviewing those actions will require a substantial amount of
resources.
MEDPAC PROVIDES TESTIMONY, BRIEFINGS, AND ASSISTANCE TO HILL STAFF
During calendar year 2003, the Commission testified before three
Congressional committees. The Commission chair testified before the
House Ways & Means, Subcommittee on Health, on the Commission's March
Report to the Congress (March 6, 2003) and on Medicare cost-sharing and
supplemental insurance (May 1, 2003). The Commission's executive
director testified before the Senate Special Committee on Aging on
disease management in traditional Medicare (November 4, 2003). In March
2004, the Commission chair testified on improving quality through
Medicare payment policy before the House Ways & Means, Subcommittee on
Health.
The Commission has provided additional support to the Congress.
From February through April 2003, the Commission briefed the Senate
Committee on Finance on selected payment systems. On separate
occasions, the executive director also briefed the members of the House
Energy and Commerce Committee and the House Rural Caucus. In addition,
the executive director briefed staff of the rural health caucus on
rural Medicare provider payments.
MedPAC staff regularly brief the health committee staff on ongoing
work by the Commission. This includes a series of conference calls and
face-to-face meetings prior to each public meeting to discuss research,
gather feedback, and provide information about Commission deliberations
and upcoming recommendations. Commission staff has also responded, both
orally and in writing, to numerous requests from Congressional staff on
a wide variety of topics. Not including minor requests, Commission
staff has filled over 100 direct requests for information from
Congressional staff, involving providing data and other substantive
analyses or explanations. Staff have also had more than 20 meetings
with or briefings for Congressional staff on related topics.
We anticipate our level of support to the Congress including
testimony, briefings, and technical assistance will increase in the
next year as issues concerning the implementation and implications of
new provisions in the MMA become more apparent.
OUTREACH
During 2003, as in previous years, MedPAC has exchanged information
and advice with other government entities involved in crafting and
assessing Medicare policy. We have met and conferred with staff from
the General Accounting Office, the Centers for Medicare & Medicaid
Services, the Congressional Budget Office, the Congressional Research
Service, the Agency for Healthcare Research and Quality, and the
Assistant Secretary for Planning and Evaluation. Exchanges with these
government entities will continue so that we coordinate our work and
minimize redundancy.
As in past years, MedPAC has continued to gather input to its
policy deliberations through meetings with outside groups. Members of
the Commission and staff will continue to meet with outside interest
groups in order to gather information for MedPAC's findings and
recommendations. In addition, in order to increase our understanding of
the health care market and the impact of Medicare payment policy on
providers, staff have made site visits to gather information. Such
efforts will continue this year.
During 2003, Commission staff extended its public outreach through
speaking at a number of conferences. Another venue for public outreach
has been staff publication of original articles based on Commission
research. Members of the staff will continue to reach out to external
groups through attendance at and presentations to academic and
professional conferences, as well as publication of articles based on
work at the Commission. Such efforts increase staff knowledge of the
broader Medicare policy context and expand public understanding of the
work of the Commission.
MEDPAC RECOMMENDATIONS HAVE BEEN ADOPTED
The Congress and CMS have adopted MedPAC's recommendations on a
range of issues. For example, the MMA reflected several of the
Commission's recent recommendations on dialysis payments, the update
for home health services, the home health rural add-on, updates to
payments for services provided at ambulatory surgical centers,
increases for physician services, and inpatient hospital payments.
OUR APPROPRIATION REQUEST FOR FISCAL YEAR 2005
For fiscal year 2005, MedPAC requests $9,905,000, which is $605,000
more than the amount requested for fiscal year 2004. Medicare, a more
than $270 billion program, represents one of the Congress' highest
priorities. The requested budget of just over $9.9 million to better
understand the policy concerns for this vital program is both
justifiable and reasonable. This amount is necessary not only to
maintain but to increase the current level of analysis, hold Commission
meetings, develop data, and meet our mandated responsibilities to the
Congress.
Our fiscal year 2005 request is driven by several factors. As
required by our authorizing legislation, during fiscal year 2005 we
will submit our March and June reports. In addition, we will complete a
significant number of new tasks, including:
--Complete 12 mandated reports included in the MMA. In addition,
MedPAC is required to consult with the IOM, GAO, and CMS on
other reports mandated in the legislation.
--Respond to more than 30 payment-related reports submitted to the
Congress by the Secretary.
--Increase the analytic scope of the commission to include
prescription drugs.
The majority of the increase in MedPAC's budget is for research
contracts, computer programming, and commercial contracts to accomplish
these new tasks. External research contracts enhance our efficiency by
providing access to areas of expertise and additional work force on an
as-needed basis. Because of MedPAC's increasing workload, access to
external research contractors is critical to providing timely advice to
Congress on key Medicare policy issues.
The increased funding will also enable us to respond to the growing
volume of informal Congressional requests for information. In addition,
it has become increasingly clear that the data available to assess the
Medicare program is inadequate and that we must strive to expand data
sources and analysis. Fulfilling Congressional requests and expanding
data sources requires increased staff time and increased computer costs
for data analysis.
While we do have significant increases in the expenses discussed
above, MedPAC has achieved certain economies. We have significantly
decreased spending on mainframe computer costs by moving data to
personal computers. In addition, continued migration away from printed
to electronic reports and internet-based resources has saved a
significant amount of money for printing and reproduction. We
anticipate these expenses will decline even further in fiscal year 2005
even though we will be delivering 12 additional reports to the Congress
during the fiscal year.
More reports, more requests for information, and more timely data
lead to an increase in our budget request. Small size, efficient
operations, and increased economies enable us to take on increased
responsibilities within, what is by any measure, a small budget in
relation to the increased leverage it gives the Congress on the
Medicare program.
______
Prepared Statement of Research to Prevention
Since June 2003, the Centers for Disease Control and Prevention
(CDC) has undertaken a strategic planning effort to prepare the agency
to address the health challenges of the 21st century. The Futures
Initiative has involved gathering information from thousands of
partners, stakeholders and the public regarding CDC's organization,
scope and reach. Key findings include a need to strengthen CDC's role
in health promotion and prevention of disease, disability, and injury.
To accomplish this, one overarching goal was identified--``All people
will achieve their optimal lifespan with the best possible quality of
health in every stage of life.''
Research to Prevention, a national coalition committed to improving
the nation's health through prevention, wholeheartedly concurs with
this goal and urges Congress to provide sufficient resources to permit
CDC to maximize its chronic disease prevention efforts throughout the
country. The coalition's members include the nation's premier voluntary
health organizations and health provider organizations, including: the
American Association of Diabetes Educators, the American Cancer
Society, the American Diabetes Association, the American Heart
Association, the Arthritis Foundation, the Chronic Disease Directors,
the Epilepsy Foundation, the Lance Armstrong Foundation, Partnership
for Prevention, Prevent Blindness America and the National Health
Council.
Research to Prevention aims to make prevention and control of
chronic diseases and disability a national policy and funding priority
by educating policymakers and advocating for vital funding increases
for comprehensive public health programs that address the nation's
leading causes of death and disability. Research to Prevention is
seeking a $340 million increase in funding in fiscal year 2004 for
State-based chronic disease prevention and control programs at the
Centers for Disease Control and Prevention (CDC). We also support an
increase in funding for the Youth Media Campaign, Racial and Ethnic
Approaches to Community Health (REACH), the Preventive Health and
Health Services Block Grant, as well as Secretary Thompson's Steps to a
Healthier U.S. initiative. The attached chart provides detail on the
specific requested funding levels.
Chronic diseases are responsible for more than 70 percent of all
U.S. deaths and more than 75 percent of all health care expenditures in
the United States. The number of deaths alone, however, fails to convey
the full picture of the toll of chronic disease. More than 125 million
Americans live with some form of chronic disease, and millions of new
cases are diagnosed each year. These serious conditions are often
treatable but not always curable. Thus, an even greater burden befalls
Americans from the disability and diminished quality of life resulting
from chronic disease.
One-third, or approximately $300 billion, of the nation's health
care budget is spent on older Americans who often have preventable or
controllable chronic diseases and conditions. Much of the disability in
old age can be delayed or prevented altogether, potentially improving
quality of life and saving the nation billions of dollars in health
care expenditures and the costs of long-term care.
Chronic disease is not just an issue among older adults. One-third
of the years of potential life lost before age 65 is due to chronic
disease. The obesity epidemic in this country is taking its toll on
young people. Since 1980, obesity rates have doubled among children and
tripled among adolescents. Unhealthy diet and physical inactivity play
an important role in many chronic diseases and conditions. As our lead
prevention agency, CDC needs additional resources to work with states,
schools and local communities to implement promising approaches for
preventing obesity.
To curb the excessive burden of chronic diseases, both in human and
economic terms, the nation must ensure that research advances are
applied, evaluated and implemented at the state and local level with
comprehensive, sustainable prevention programs. CDC plays an essential
role in translating and delivering at the community level what is
learned from research--especially ensuring that those populations
disproportionately affected by chronic disease and disabilities receive
the benefits of our nation's investment in medical research. Effective
interventions need to be developed and implemented to reduce the
disabling consequences of these diseases, including blindness, kidney
failure, paralysis, fractures, joint deterioration, and limb loss.
Research to Prevention stands ready to work with the Members of
this Subcommittee to help make it possible for every state in the
nation to develop and deliver health promotion, health education and
disease prevention programs to address chronic diseases and disability.
By committing a minimum increase of $340 million in fiscal year 2005
for state-based chronic disease programs, we can work to make this a
reality.
All states need and deserve statewide implementation grants for the
leading causes of death and disability (heart disease and stroke,
diabetes, cancer and arthritis) and their risk factors (physical
activity, nutrition, obesity, and tobacco use). Emerging chronic
conditions, such as epilepsy and complications associated with chronic
disease, such as vision loss and oral disease must also be addressed.
States also need to track progress statewide through disease registries
and behavioral surveys, including the stroke and cancer registries and
the Behavioral Risk Factor Surveillance System (BRFSS). The BRFSS
information is essential for planning, conducting and evaluating public
health programs at the national, state and local levels. Additionally,
private organizations rely on the survey data to develop health
promotion programs to reduce the prevalence of unhealthy behaviors and
to document their effectiveness.
YOUTH MEDIA CAMPAIGN
Research to Prevention supports a $89 million increase above fiscal
year 2004 to restores funding to its $125 million level in fiscal year
2001. This campaign--known as VERB--is designed to give kids a positive
advertising message about being physically active through paid media,
partnerships, and community efforts. In February 2004, the CDC released
the first survey results that indicate physical activity among the
nation's youth is increasing as a result of the VERB campaign. A 34
percent increase in weekly free-time physical activity sessions among
8.6 million children ages 9-10 in the United States. R2P believes that
VERB should be expanded so that even more children will be exposed to
healthy messages and increase their chances of becoming more physically
active.
REACH
Research to Prevention supports a $12.7 million increase in the
REACH program for a total of $50 million in fiscal year 2005. Launched
in 1999, the REACH 2010 is the cornerstone of CDC's efforts to
eliminate racial and ethnic disparities in health. This project is
designed to eliminate health disparities in cardiovascular disease,
immunizations, breast and cervical cancer screening and management,
diabetes, HIV infections/AIDS, and infant mortality. The racial and
ethnic groups targeted by REACH 2010 are African Americans, American
Indians, Alaska Natives, Asian Americans, Hispanic Americans, and
Pacific Islanders. REACH 2010 is unique because it works across public
and private sectors to conduct community-based prevention research to
identify the causes of health disparities. Culturally appropriate,
community-driven programs are critical for eliminating racial and
ethnic disparities in health. A $50 million allocation would support
expansion of community-driven programs and evaluation of successful
efforts to build capacity; target action; conduct community/systems
change; eliminate health disparities; and translate and disseminate
results.
PREVENTIVE HEALTH AND HEALTH SERVICES BLOCK GRANT
Research to Prevention supports an increase of $76.7 million to
additional clinical services, preventive screening, laboratory
research, outbreak control, workforce training, public education, data
surveillance, and program evaluation. The funds are used to target the
265 national health objectives in Healthy People 2010 which address
cardiovascular disease, cancer, diabetes, emergency medical services,
injury and violence, infectious disease, environmental health,
community fluoridation, and sex offenses. Because of the allowed
flexibility in the use of the funds, states allocate their block grant
resources to address areas of greatest need and target populations. A
strong emphasis is placed on programs for adolescents, communities with
limited health care services, and disadvantaged populations. Since so
many states lack funding to address many of the chronic diseases,
states have used much of their block grant money to address the leading
killers. This program facilitates coordination between states and their
local governments since approximately 43 percent of PHHS block grant
funds were distributed by the states to meet county and local public
health needs.
THE ADMINISTRATION'S HEALTHY STEPS INITIATIVE
Research to Prevention supports the Secretary's goals of reducing
the burden of chronic diseases and applauds him for his continuing
commitment to chronic disease prevention. The requested increase of
$81.3 million to support the Steps to a Healthier U.S. Initiative can
assist the states, local governments and community organizations to
increase their efforts to improve health and well being. While the
states already distribute approximately 75 percent of their CDC
resources directly to community programs, they still lack the resources
necessary to reach many of their communities. States are the engine to
reach those communities and the Secretary's Steps Initiative provides
the gas for the engine. State-based chronic disease funding and the
Steps Initiative need to advance together if we are to reduce death and
disability and enhance quality of life.
Research to Prevention thanks the Subcommittee for the opportunity
to submit testimony and stands ready to work with all Members to reduce
and prevent the economic and social burden of chronic disease on our
nation.
RESEARCH TO PREVENTION MEMBERS
American Association of Diabetes Educators; American Cancer
Society; American College of Preventive Medicine; American Dental
Association; American Diabetes Association; American Heart Association;
American Public Health Association; American School Health Association;
Arthritis Foundation; Association of State and Territorial Chronic
Disease Program Directors; Association of State and Territorial
Directors of Health Promotion and Public Health Education; Coalition of
National Health Education Associations; Center for Science in the
Public Interest; Eli Lilly and Company; Epilepsy Foundation; Lance
Armstrong Foundation; Missouri Primary Care Association; National
Health Council; National Kidney Foundation, Inc.; Oncology Nursing
Society; Partnership for Prevention; Prevent Blindness America; Society
for Public Health Education; and YMCA of the USA.
CDC CHRONIC DISEASE PROGRAMS--FISCAL YEAR 2005 RECOMMENDATIONS
[In millions of dollars]
------------------------------------------------------------------------
Fiscal year Increase
------------------------------ over
fiscal
2003 2004 2005 R2P year
enacted enacted targets 2004
------------------------------------------------------------------------
NATIONAL CENTER CHRONIC DISEASE 963.1 1,024.4 1,613.5 589.0
PREVENTION AND HEALTH PROMOTION
Chronic Disease Line............ 790.5 853.8 1,353.5 499.6
Arthritis....................... 15.6 15.8 25.0 9.2
Lupus....................... 1.0 1.0 ........ ........
Cancer Prevention and Control... 287.8 313.6 410.0 96.4
B&C Mort Prev............... 199.4 209.5 250.0 40.5
WISEWOMAN................... 14.0 14.0 20.0 6.0
Comprehensive Cancer........ 9.4 11.9 25.0 13.1
Ovarian..................... 4.4 4.9 10.0 5.1
Prostate.................... 14.0 15.5 20.0 4.5
Colorectal.................. 13.4 14.9 25.0 10.1
Skin........................ 1.6 2.2 10.0 7.8
Registries.................. 45.6 49.7 65.0 15.3
Community Health Promotion...... 22.1 24.0 37.3 13.3
BRFSS....................... 6.9 8.1 18.0 10.0
Com Health Promotion............ 8.9 8.3 8.3 ........
Compl/Alt Med............... 1.7 1.8 2.0 0.2
Glaucoma/Vision Screening... 4.7 5.8 9.0 3.2
Diabetes........................ 63.3 66.9 150.0 83.1
Epilepsy........................ 7.5 8.2 13.2 5.0
Heart Disease and Stroke........ 43.0 45.7 80.0 34.3
Paul Coverdell Stroke 5.0 5.0 5.0 ........
Registry...................
Nutrition/Phys Activity/Obesity. 34.1 44.7 75.0 30.3
Micronutrients.............. 5.0 0.4 ........ ........
Iron Overload............... 0.4 0.4 ........ ........
Oral Health..................... 11.7 12.4 20.0 7.6
Prevention Research Centers..... 26.8 26.7 26.7 ........
Safe Motherhood /Infant Health.. 54.0 53.9 53.9 ........
School Health................... 57.8 62.4 82.4 20.0
Coordinated School Health... 10.8 15.7 35.7 20.0
HIV......................... 47.0 46.7 46.7 ........
Tobacco......................... 99.9 99.7 130.0 30.3
ADDITIONAL TARGETS:
STEPS....................... 15.4 43.7 125.0 81.3
Youth Media Campaign........ 51.0 35.8 5.0 89.2
PHHS BLOCK GRANT............ 135.0 133.3 210.0 76.7
REACH....................... 37.6 37.3 50.0 12.7
------------------------------------------------------------------------
______
Prepared Statement of the Association of University Programs in
Occupational Health and Safety
Thank you for the opportunity to present testimony to the
Subcommittee in support of funding for the National Institute for
Occupational Safety and Health (NIOSH) and for the NIOSH-funded
Education and Research Centers (ERCs). My name is Jackie Agnew, and I
am the Director of the Education and Research Center at Johns Hopkins
University Bloomberg School of Public Health.
I am testifying on behalf of the Association of University Programs
in Occupational Health and Safety (AUPOHS), the organization that
represents 16 multi-disciplinary, NIOSH-supported, university-based
Education and Research Centers (ERCs). The ERCs are regional resources
for all parties involved with occupational health and safety--industry,
labor, government, academia, and the general public. The ERCs play the
following roles in helping the nation reduce losses associated with
work-related illnesses and injuries:
--Prevention Research.--Developing the basic knowledge and associated
technologies to prevent work-related illnesses and injuries.
--Professional Training.--Graduate degree programs in Occupational
Medicine, Occupational Health Nursing, Safety Engineering, and
Industrial Hygiene to provide qualified professionals in
essential disciplines.
--Research Training.--Preparing doctoral-trained scientists who will
respond to future research challenges and who will prepare the
next generation of occupational health and safety
professionals.
--Continuing Education.--Short courses designed to enhance
professional skills and maintain professional certification in
occupational health and safety disciplines. These courses are
delivered on-campus at the 16 ERCs as well as through distance
learning technologies.
--Regional Outreach.--Responding to specific requests from local
employers and workers on issues related to occupational health
and safety.
THE SCOPE OF THE PROBLEM OF OCCUPATIONAL INJURY AND ILLNESSES
The many causes of occupational injury and illness represent a
striking burden on America's health and well-being. Yet, despite
significant improvements in workplace safety and health over the last
several decades:
--There were 5,524 occupational fatalities in 2002, for an average of
15 workers per day who died from work-related injuries; and
--More than 4.7 million workers sustained work-related injuries and
illnesses in the private sector alone in that same year.
--The economic toll of work-related illness and injury on the
nation's employers, workers and their families, and society
overall reached an estimated $45.8 billion in 2001, with $137.4
to $229 billion more in indirect costs.
This is an especially tragic situation because most work-related
fatalities, injuries and illnesses are preventable with effective,
professionally directed, health and safety programs. Although our
nation has made tremendous progress in reducing occupational illnesses
and injuries during the past 30 years, leading to a decline in the rate
of total recordable cases from 11.0 to 7.1 cases per 100 full-time
workers between 1973 to 1997, the burden of occupational illnesses and
injuries remains unacceptably high.
Furthermore, we do not live in a static environment. The rapidly
changing workplace continues to present new health risks to American
workers that need to be addressed through occupational safety and
health research. For example, by the year 2005, an estimated 33 percent
of the U.S. workforce will be 45 years or older. Work-injury fatality
rates begin increasing at age 45, with rates for workers 65 years and
older nearly three times as high as the average for all workers.
Despite being the primary federal agency for occupational disease and
injury prevention in the nation, NIOSH receives only about $1 per
worker per year for its mission of research, professional education,
and outreach.
HOMELAND SECURITY
The heightened awareness of terrorist threats, and the increased
responsibilities of first responders and other homeland security
professionals, illustrates the need for strengthened workplace health
and safety in the ongoing war on terror. The NIOSH ERCs play a crucial
role in preparing Occupational Safety and Health (OSH) professionals to
identify and ameliorate vulnerabilities to terrorist attacks and other
workplace hazards and increase readiness to respond to biological,
chemical, or radiological attacks.
Thanks to the Subcommittee's support for occupational health and
safety research, NIOSH developed more effective methods to test for
anthrax contamination in congressional offices. These procedures were
quickly adopted by the Coast Guard, the FBI, and government building
contractors.
In addition, occupational health and safety professionals have
worked for several years with emergency response teams to minimize
losses in the event of a disaster. NIOSH took a lead role in protecting
the safety of emergency responders in New York City and Virginia, with
ERC-trained professionals applying their technical expertise to meet
immediate protective needs and conducting ongoing activities to
safeguard the health of clean-up workers.
In the face of the growing concerns surrounding homeland security,
ERCs have rapidly upgraded research coordination and expanded training
opportunities, including sponsoring national and regional forums on
response to bioterrorism and other disasters.
THE NEED FOR OCCUPATIONAL SAFETY AND HEALTH MANPOWER
The NIOSH ERCs were reviewed by the DHHS Office of the Inspector
General in 1995. The resulting report affirmed the efficacy of the ERCs
in producing graduates who pursue careers in occupational safety and
health. Since the ERCs are regional, they are ready to respond to
various trends in industries throughout the country. And because they
provide training that is multi-disciplinary, ERCs graduate
professionals who can protect workers in virtually every walk of life.
Despite the recognized success of the ERCs in training qualified
occupational health and safety professionals, the country continues to
have ongoing shortages. The manpower needs are especially acute for
doctoral-level trained professionals who can conduct research and help
in implementing the National Occupational Research Agenda.
In May 2000, the Institute of Medicine issued its final report on
the education and training needs for occupational safety and health
(OSH) professionals in the United States. This report concluded that
``the continuing burden of largely preventable occupational diseases
and injuries and the lack of adequate OSH services in most small and
many larger workplaces indicate a clear need for more OSH professionals
at all levels.'' Specific needs identified by the IOM report include:
--An insufficient number of doctoral-level graduates in occupational
safety, thus limiting the nation's capacity to perform
essential research and training in traumatic injury prevention.
--An inability to attract physicians and nurses into formal OSH
academic training programs, thus limiting the resources needed
to deliver occupational health services.
NEW NIOSH INITIATIVE: MOVING RESEARCH INTO PRACTICE
The health of the U.S. economy depends upon a healthy and
productive workforce. Through its targeted research and prevention
programs, as well as its programs of tracking diseases, injuries, and
hazards; capacity building; and rapid dissemination of useful
information, NIOSH contributes to the nation's progress in reducing
workplace injuries and illnesses and enhancing the health and safety of
U.S. workers.
In 1996, NIOSH established the National Occupational Research
Agenda (NORA), a framework to guide and promote occupational safety and
health research through a consensus-building process with more than 500
outside organizations and individuals. The NORA process identified the
top 21 research priorities for occupational safety and health for the
nation.
NIOSH has long been committed to translating research results into
practical recommendations and disseminating them through its
publications. For example, ``Alerts'' help employers and workers
identify and respond to work-related health hazards, and ``Workplace
Solutions'' provide practical advice on hazard control. NIOSH is now
building even further on these efforts by launching Research to
Practice, or r2p, a new initiative to transfer research findings,
technologies, and information into effective prevention practices and
products and to promote their adoption in workplaces.
The goal of the NIOSH r2p initiative will be to increase the use in
the workplace of effective NIOSH and NIOSH-funded research findings.
NIOSH will achieve this goal by translating its research findings into
practice as quickly as possible, targeting its dissemination efforts,
and evaluating and demonstrating the effectiveness of these efforts in
improving worker health and safety. ERCs will play a prominent role in
this process.
In addition, in coordination with the HHS Secretary's Steps to a
HealthierUS initiative, NIOSH is introducing Steps to a HealthierUS
Workforce to encourage workplace health programs that effectively
integrate or coordinate efforts to promote both personal health and
workplace health. Through NORA, r2p, and Steps to a HealthierUS
Workforce, NIOSH will continue to work to achieve its goal of
preventing work-related illnesses and injuries. These efforts will
continue to be enhanced through partnerships, outreach, and capacity-
building to enable NIOSH to leverage resources and expertise.
RECOMMENDATION FOR FISCAL YEAR 2005
AUPOHS requests an increase of $5 million for ERCs, and we are
supporting a $30 million total increase over the $277 million
appropriated in fiscal year 2004 for NIOSH.--This would provide $307
million for NIOSH and $24.7 million for ERCs in fiscal year 2005. Given
that much of NIOSH's extramural research program is carried out by our
institutions, sustaining the academic infrastructure provided by the
ERCs is essential to the success of NORA, r2p, and Steps to a
HealthierUS Workforce. Our recommendation would ensure that our
nation's universities have the capacity and manpower to implement these
initiatives and expand training programs to improve the health and
productivity of American workers.
Funding for NIOSH and the ERCs would reduce the staggering burden
of occupational illnesses and injury on the American economy, recently
estimated at $240 billion. To put this number in perspective, these
costs dwarf the $33 billion for AIDS and the $67 billion for
Alzheimer's disease, and they are greater than the $164 billion
economic cost for all circulatory diseases and the $171 billion cost of
cancer. Yet federal support for occupational safety and health research
pales in comparison--for example, cancer research receives 17 times as
much federal funding.
Thank you for the opportunity to report the great need for research
and training in occupational safety and health.
NIOSH-SUPPORTED EDUCATION AND RESEARCH CENTERS (ERCS)
Deep South ERC (University of Alabama at Birmingham and Auburn
University); Harvard University; Johns Hopkins University; New York /
New Jersey ERC (Mt. Sinai Medical Center and Hunter College); Northern
California ERC (UC Berkeley, UCSF); Southern California ERC (UCLA and
UC Irvine); Texas ERC (University of Texas and Texas A&M University);
University of Cincinnati; University of Illinois at Chicago; University
of Iowa; University of Michigan; University of Minnesota; University of
North Carolina at Chapel Hill; University of South Florida; University
of Utah; and University of Washington.
______
Prepared Statement of Rotary International
Chairman Specter, Senator Harkin, members of the Subcommittee,
Rotary International appreciates this opportunity to submit testimony
in support of the polio eradication activities of the U.S. Centers for
Disease Control and Prevention (CDC). The effort to eradicate polio has
been likened to a race--a race to reach the last child. This race
requires the dedication to make the sacrifices necessary to achieve
success. Like some great relay team, the major partners in the global
polio eradication effort have joined with national governments around
the world in an unprecedented demonstration of commitment to cross the
finish line of this historic public health goal. We cannot allow the
great distance we have traveled to diminish our resolve. Though we may
be weary, our adversary is weakening. The victory over polio is closer
than ever!
PROGRESS IN THE GLOBAL PROGRAM TO ERADICATE POLIO
I would like to take this opportunity to thank you Chairman
Specter, Senator Harkin, and members of the Subcommittee for your
tremendous commitment to this effort. Without your support of CDC's
polio eradication activities, the battle against polio would be
impossible. Thanks to your leadership in appropriating funds, the
international effort to eradicate polio has made tremendous progress.
--The number of polio cases has fallen from an estimated 350,000 in
1988 to less than 800 in 2003--a more than 99 percent decline
in reported cases (see Exhibit A). More than 200 countries and
territories are polio-free, including 4 of the 5 most populous
countries in the world (China, United States, Indonesia, and
Brazil).
--Transmission of the poliovirus has never been more geographically
confined. The Western Hemisphere, the Western Pacific and the
European regions are certified polio-free. Wild poliovirus
transmission is confined to a limited number of polio ``hot-
spots'' within six countries.
--More than 2 billion children worldwide have been immunized during
NIDs in the last 5 years, including more than 150 million in a
single day in India.
--All polio-endemic countries in the world have conducted NIDs and
established high quality surveillance of Acute Flaccid
Paralysis (AFP). The eradication of polio in the Democratic
Republic of Congo, Sudan, and Somalia shows that polio
eradication strategies are successful even in countries
affected by civil unrest.
From the launch of the global initiative in 1988, to the
eradication target date of 2005, 5 million people who would otherwise
have been paralyzed will be walking because they have been immunized
against polio. Tens of thousands of public health workers have been
trained to investigate cases of acute flaccid paralysis and manage
massive immunization programs. Cold chain, transport and communications
systems for immunization have been strengthened. A network of 147 polio
laboratories has been established to analyze suspected cases of polio
and monitor transmission of polio. This network will continue to
support the surveillance of other diseases long after polio has been
eradicated.
Give the tremendous progress that has been made in reducing the
incidence of polio and diminishing the areas in which the virus
circulates, the world currently faces an unprecedented opportunity to
stop the transmission of wild poliovirus. However, significant
challenges remain as obstacles to the ultimate achievement of our goal
of a polio-free world. In 2003, Nigeria surpassed India to become the
country with the highest number of polio cases. The surge in polio
cases in Nigeria also resulted in importations of cases into several of
the countries that neighbor Nigeria. The risk of importations into west
and central African countries, and around the world, is magnified by
financial constraints that limit the scope of immunization activities.
Continued political commitment is essential in all polio endemic
countries, to support the acceleration of eradication activities. The
ongoing support of donor countries is essential to assure the necessary
human and financial resources are made available to polio-endemic
countries. Access to children is needed, particularly in Nigeria, where
political and financial differences between key states and the federal
government were unexpectedly given voice in the form of untrue rumors
about the safety of the oral polio vaccine. As a result, immunization
activities in the states that need them most were delayed and/or
suspended during the effort to address local concerns. Polio-free
countries must maintain high levels of routine polio immunization and
surveillance. The continued leadership of the United States is critical
to ensure we meet these challenges.
THE ROLE OF ROTARY INTERNATIONAL
Since 1985, Rotary International, a global association of more than
30,000 Rotary clubs, with a membership of over 1.2 million business and
professional leaders in 166 countries, has been committed to battling
this crippling disease. In the United States today there are nearly
7,700 Rotary clubs with some 400,000 members. All of our clubs work to
promote humanitarian service, high ethical standards in all vocations,
and international understanding. Rotary International stands hand-in-
hand with the United States Government and governments around the world
to fight polio through local volunteer support of National Immunization
Days, raising awareness about polio eradication, and providing
financial support for the initiative. In 2003, members of Rotary clubs
around the world announced the results of their second polio
eradication fundraising campaign. Rotarians far exceeded the U.S. $80
million goal they had set by raising U.S. $119 million in cash and
commitments. Rotary firmly believes that the vision of a world without
polio can be realized and that the time for action is now. By the time
the world is certified polio-free, Rotary's contribution to the global
polio eradication effort will exceed U.S. $600 million.
Rotary International's commitment to the global polio eradication
represents the largest contribution by an international service
organization to a public health initiative ever. These funds have been
allocated for polio vaccine, operational costs, laboratory
surveillance, cold chain, training and social mobilization in 122
countries. More importantly, tens of thousands of Rotarians have been
mobilized to work together with their national ministries of health,
UNICEF and WHO, and with health providers at the grassroots level in
thousands of communities.
In the United States, Rotary has formed and leads the United States
Coalition for the Eradication of Polio, a group of committed child
health advocates that includes Rotary, the March of Dimes Birth Defects
Foundation, the American Academy of Pediatrics, the Task Force for
Child Survival and Development, the United Nations Foundation, and the
U.S. Fund for UNICEF. These organizations join us in expressing our
gratitude to you for your staunch support of the international program
to eradicate polio. For fiscal year 2004, you appropriated a total of
$106.4 million for the polio eradication efforts of the CDC. This
investment has helped to make the United States the leader among donor
nations in the drive to eradicate this crippling disease.
FISCAL YEAR 2005 BUDGET REQUEST
For fiscal year 2005, we respectfully request that you maintain the
level of funding that was provided in fiscal year 2004 ($106.4 million)
for the targeted polio eradication efforts of the Centers for Disease
Control and Prevention. It is important to meet this level of funding
due to the increased costs of the accelerated eradication program, and
to respond to the increase in supplementary immunization activities in
endemic countries, the need to maintain immunity in polio-free areas
and maintain certification standard surveillance. This will ensure that
we protect the substantial investment we have made to protect the
children of the world from this crippling disease by enabling us to
conduct the necessary eradication activities to eliminate polio in its
final strongholds--the Indian sub-continent and sub-Saharan Africa.
THE ROLE OF THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
Rotary commends CDC for its leadership in the global polio
eradication effort, and greatly appreciates the Subcommittee's support
of CDC's polio eradication activities. For fiscal year 2004, the
Subcommittee appropriated a total of $106.4 million for the CDC's
global polio eradication activities. Due to Congress' unwavering
support, in 2004 CDC is able to:
--Support the international assignment of more than 200 long-term
epidemiologists, virologists, and technical officers to assist
the World Health Organization and polio-endemic countries to
implement polio eradication strategies, and 16 technical staff
to assist UNICEF and polio-endemic countries. This includes 19
CDC staff on direct assignment to WHO and UNICEF.
--Provide $50 million to UNICEF for approximately 540 million doses
of polio vaccine and $9 million for operational costs for NIDs
in all polio-endemic countries and other high-risk countries in
Asia, the Middle East and Africa. Most of these NIDs would not
take place without the assurance of CDC's support.
--Provide over $18 million to WHO for surveillance, technical staff
and NIDs' operational costs, primarily in Africa. As successful
NIDs take place, surveillance is critical to determine where
polio cases continue to occur. Effective surveillance can save
resources by eliminating the need for extensive immunization
campaigns if it is determined that polio circulation is limited
to a specific locale.
--Train virologists from all over the world in advanced poliovirus
research and public health laboratory support. CDC's Atlanta
laboratories serve as a global reference center and training
facility.
--Provide the largest volume of both operational (poliovirus
isolation) and technologically sophisticated (genetic
sequencing of polio viruses) lab support to the 147
laboratories of the global polio laboratory network. CDC has
the leading specialized polio reference lab in the world.
--Serve as the primary technical support agency to WHO on scientific
and programmatic research regarding: (1) laboratory containment
of wild poliovirus stocks following polio eradication, and (2)
when and how to stop or modify polio vaccination worldwide
following global certification of polio eradication in 2005.
OTHER BENEFITS OF POLIO ERADICATION
Increased political and financial support for childhood
immunization has many documented long-term benefits. Polio eradication
is helping countries to develop public health and disease surveillance
systems useful in the control of other vaccine-preventable infectious
diseases.
Already all 47 countries of the Americas are free of indigenous
measles, due in part to improvements in the public health
infrastructure implemented during the war on polio. The disease
surveillance system--the network of laboratories and trained personnel
established during the Polio Eradication Initiative--is now being used
to track measles, rubella, yellow fever, meningitis, and other deadly
infectious diseases. NIDs for polio have been used as an opportunity to
give children essential vitamin A, which, like polio, is administered
orally, saving the lives of 1.25 million children since 1998. The
campaign to eliminate polio from communities has led to an increased
public awareness of the benefits of immunization, creating a ``culture
of immunization'' and resulting in increased usage of primary health
care and higher immunization rates for other vaccines. It has improved
public health communications and taught nations important lessons about
vaccine storage and distribution, and the logistics of organizing
nation-wide health programs. Additionally, the unprecedented
cooperation between the public and private sectors serves as a model
for other public health initiatives. Polio eradication is a cost-
effective public health investment, as its benefits accrue forever.
RESOURCES NEEDED TO FINISH THE JOB OF POLIO ERADICATION
The World Health Organization estimates that $765 million is needed
from donors for the period 2004-2005 to help polio-endemic countries
complete the polio eradication strategy. In the Americas, some 80
percent of the cost of polio eradication efforts was borne by the
national governments themselves. However, as the battle against polio
is taken to the poorest, least-developed nations on earth, and those in
the midst of civil conflict, many of the remaining polio-endemic
nations can contribute only a small percentage of the needed funds. In
some countries, up to 100 percent of the NID and other polio
eradication costs must be met by external donor sources. We ask the
United States to continue its financial leadership in order to see this
initiative to its successful conclusion as quickly as possible.
The United States' commitment to polio eradication has stimulated
other countries to increase their support. Other countries that have
followed America's lead and made special grants for the global Polio
Eradication Initiative include the United Kingdom ($425 million), the
Netherlands ($112 million), and Canada ($85 million). Japan, which has
contributed $231 million, recently expanded its support to polio
eradication efforts in Africa. Even the tiny country of Luxembourg has
invested in global polio eradication by contributing $4.2 million. In
both 2002 and 2003 the members of the G8 committed to provide
sufficient resources to eradicate polio as part of its Africa Action
Plan. In addition to the ongoing contributions made by historic donors
such as United States, the United Kingdom, and Canada, new commitments
of $37 million and $4 million were made by France and Russia in
response to the G8 pledge.
Intense political commitment on the part of endemic nations is also
essential to ensuring polio eradication is achieved. In January 2004,
health ministers of the six remaining endemic countries (Afghanistan,
Egypt, India, Niger, Nigeria, and Pakistan) gathered at a meeting
convened at WHO in Geneva to declare their commitment to supporting
intensified supplementary immunization activities in the ``Geneva
Declaration for the Eradication of Poliomyelitis.'' In addition,
resolutions supporting polio eradication were taken by the African
Union and the Organization of the Islamic Conference. Each of these
resolutions encourages member states to place a high priority on
completing the job of polio eradication.
Your discipline, commitment and endurance have brought us to the
brink of victory in the great race against this ancient scourge. Polio
cripples and kills. It deprives our children of the capacity to run,
walk and play. Other great health crises loom on the horizon. Your
continued support for this initiative helps ensure that today's
children possess the strength and vitality to grow up and fight against
the health threats of future generations.
______
Prepared Statement of the National Council on Folic Acid
The National Council on Folic Acid (NCFA) is a partnership of over
80 national organizations and associations, state folic acid councils
and government agencies whose mission is to improve health by promoting
the benefits and consumption of folic acid. Our goals are to reduce
folic acid preventable birth defects by recommending that women of
childbearing age take 400 micrograms of synthetic folic acid daily,
from fortified foods and/or supplements, in addition to consuming food
folate from a varied diet and to communicate and promote emerging and
new science on folic acid, especially that relate to maternal and child
health. The undersigned members of NCFA respectfully recommend that at
least $5 million be appropriated in fiscal year 2005 for the Centers
for Disease Control and Prevention's Folic Acid Education Campaign.
FOLIC ACID AND BIRTH DEFECTS
Folic acid, a B-vitamin, is critical for proper cell division and
growth. It is especially important during the early weeks of pregnancy
when the embryonic neural tube, which later becomes the brain and
central nervous system, is forming and closing. Defects in closure of
the neural tube result in the development of a group of birth defects
commonly referred to as neural tube defects (NTDs). The two most common
NTDs are spina bifida and anencephaly. Closure of the neural tube
occurs early in the development, before most women know that they are
pregnant. The consumption of only 400 micrograms of folic acid daily
taken prior to conception and early in gestation can prevent as many as
70 percent of NTDs.
The birth defects such as anencephaly and spina bifida, have a
great social and economic impact on our nation. The average total
lifetime cost to society for each infant born with spina bifida is
approximately $532 thousand, while estimated annual medical and
surgical costs for persons living with spina bifida in the United
States exceed $200 million.\1\ Fortification of the grain supply is a
significant factor in the 32 percent decline in the rates of spina
bifida. In order to continue this trend, however, considerable effort
is still needed to increase the number of reproductive aged women who
consume 400 micrograms of folic acid each day. But, due to the growing
popularity of low-carbohydrate diets many women are abandoning bread
and other grains, thereby reducing their intake of folic acid.
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\1\ Centers for Disease Control and Prevention, MMWR, 1989.
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FOLIC ACID AWARENESS AND COUNSELING
Only 20 percent of women know that folic acid can prevent birth
defects.\2\ Consequently, women generally are low consumers of folic
acid, with only 30 percent of all women consuming a vitamin supplement
with folic acid every day. Of those who take a daily multi-vitamin, 25
percent forget to take it every day.
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\2\ March of Dimes, June 2002.
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We know that health care providers should screen women of
childbearing age for folic acid consumption in an effort to promote
taking a daily multi-vitamin and to prevent neural tube defects. We
also know that 53 percent of women not taking a daily multi-vitamin
indicated that they would likely do so if their health provider simply
encouraged them.\3\
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\3\ March of Dimes, June 2002.
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Following that logic, the undersigned NCFA members recommend that
at least $5 million be appropriated to fund the Centers for Disease
Control and Prevention's Folic Acid Education Campaign, which is housed
with the National Center on Birth Defects and Developmental
Disabilities. This funding is necessary to continue the Center's
programming devoted on raising folic acid public awareness and training
of health professionals on how to discuss folic acid consumption with
their patients.
______
Prepared Statement of the American Academy of Family Physicians
The 93,700-member American Academy of Family Physicians submits
this statement for the record in support of the Section 747 Primary
Care Medicine and Dentistry Cluster. The Academy also supports the
Agency for Healthcare Research and Quality (AHRQ) and rural health
programs.
Section 747 is the only national program that funds family
physician training and includes dollars for general internal medicine/
general pediatrics; physician assistants and general/pediatric
dentistry. The fiscal year 2004 spending bill provides only $82 million
to Section 747, a figure that is $10 million below the fiscal year 2003
levels. The Congressionally established Advisory Committee on Training
in Primary Care Medicine and Dentistry (ACTPCMD) recommends $198
million for Section 747.
SECTION 747 PRIMARY CARE MEDICINE AND DENTISTRY CLUSTER
Background
Section 747 supports family medicine training programs in medical
school and in residency programs. It is specifically designed to meet
two goals: increase the number of primary care physicians, and boost
the number of people who will provide care to the underserved. The
Institute of Medicine defines primary care physicians as family
physicians, general internists and general pediatricians.
Family physicians provide comprehensive, coordinated and continuing
care to patients of both genders and all ages and ethnicities,
regardless of medical condition. These residency-trained, primary care
specialists treat babies with ear infections, adolescents who are
obese, adults with depression and seniors with multiple, chronic
illnesses. And because they focus on prevention, primary care, and
integrating care for patients, they are able to treat illnesses early;
cost-effectively and when necessary, help patients navigate our complex
health system and find the right subspecialists.
Section 747 funding has led thousands of physicians to go into
primary care and family medicine and serve millions of patients. A
study by the Robert Graham Center for Policy Studies showed that
medical schools that received Section 747 family medicine funds
produced more medical students who:
--Practiced in family medicine or primary care;
--Practiced in a rural area; or
--Practiced in a whole county Primary Care Health Professions
Shortage Area (HPSAs) (i.e., counties with inadequate numbers
of family physicians, general pediatricians, general internists
or obstetrician/gynecologists).
The study showed that continued funding during the years of medical
school training had more of a positive impact than intermittent
funding.
Another Graham Center report revealed that more Americans depend on
family physicians than any other medical specialty: without family
physicians, the majority of U.S. counties would become Primary Care
Health Professions Shortage Areas. Of the 3,142 counties in the United
States, 1,184 (38 percent) are full or partial county HPSAs, which
includes more than 41 million Americans.
Funding for Programs Historically Under Threat
However, the health professions programs have been under fire for
many years, and, as a result, funding has been threatened during
several fiscal cycles. For example, the Administration's fiscal year
2005 budget would eliminate funding for Section 747 and cuts funding
severely for Title VII. Reasons differ for these cutbacks, but center
mainly around disagreements regarding the long-term role of the federal
government in training physicians, and uncertainty about program
outcomes and effectiveness.
Most recently, the Office of Management and Budget (OMB) attempted
to express these arguments in the 2003 Program Assessment Rating Tool
(PART). In that document, OMB criticized all of the Title VII Health
Professions programs as lacking a focused objective. However, Section
747, in particular, has a clear purpose and has been successful in
achieving its goals. The OMB evaluation lumps all of the programs
together and does not evaluate them individually. By definition, these
programs will have different goals, different levels of effectiveness
and different histories, making the PART evaluation unsophisticated, at
best. Additionally, since the federal government has been struggling
with a budget shortfall, programs with the slightest amount of negative
attention have been tempting targets for budget cutbacks.
Nonetheless, these training programs still enjoy a great deal of
support from members of the Appropriations Committees in both the
Senate and House, which the Academy appreciates. And, with the
exception of the fiscal year 2004 spending bill, Congress has
consistently restored funding for these programs.
The Academy strongly believes that the federal government must
maintain appropriate funding for Section 747 family medicine training
programs. The rationale for this comes from two sources: the steady
reliance on family physicians in the current U.S. healthcare system and
the Academy's new proposal to restructure future Section 747 family
medicine training programs for the coming healthcare system. In short,
family physicians are key to a modern healthcare system and more money
is needed to modernize their training.
Preserve the U.S. Health Care Safety Net
The Academy supports the Administration's commitment to funding
increases to build more Community Health Centers (CHC) and supplement
the National Health Service Corps (NHSC). However, we believe that
increasing funding for CHCs and the NHSC is only a partial solution.
Without support for family physician training, there will be fewer of
the physicians who work in these centers or practice in underserved
areas. Thousands of family physicians will be needed if the growth in
the number of CHCs sites and NHSC staff is to be realized.
Specifically, nearly half of the physicians who staff the nation's
Community Health Centers are family physicians. And, since 1971, the
National Health Service Corps has placed more than 18,000 health care
providers in underserved areas: almost half of the NHSC doctors were
family physicians. Finally, according to data from the National
Association of Community Health Centers, in 2002, the majority of CHC
employees were primary care physicians who were responsible for almost
22 million patient visits.
Invest in Cost-Effective, Quality Care
Unlike all other developed countries, the United States does not
have a primary care-based health care system. While other developed
countries have about equal numbers of primary care doctors and
subspecialists, less than one-third of the U.S. physician workforce is
primary care doctors (including family physicians). As a result, about
two thirds of the U.S. physician workforce is made up of
subspecialists.
In addition, compared to those in other developed countries, we
spend the most per capita on healthcare but have the worst healthcare
outcomes. More than 20 years of evidence have shown that a primary
care-based health system produces greater health and economic benefits.
Boosting support for Section 747, which funds training for family
physicians and for other primary care disciplines, could allow patients
in the United States to enjoy those benefits.
Specifically, research reveals that primary care is effective:
leading to reduced all-cause mortality and mortality due to
cardiovascular and pulmonary diseases; less emergency department and
hospital use; better preventive care; better detection of breast
cancer, and reduced incidence and mortality due to colon and cervical
cancer. Studies have also shown proof of efficiency: fewer tests;
higher patient satisfaction; lower medication use and lower care-
related costs. Finally, the data indicates that primary care promotes
equity among different populations: health disparities are reduced,
particularly for areas with the highest income inequality, resulting in
improved vision, more complete immunization, better blood pressure
control, and better oral health. Supporting Section 747 family medicine
training would produce more family physicians, physicians who are cost-
effective and provide high quality care.
AGENCY FOR HEALTHCARE, RESEARCH AND QUALITY
The Academy recommends $443 million for the Agency for Healthcare,
Research and Quality (AHRQ). AHRQ conducts primary care and health
services research geared to physician practices, health plans and
policymakers that helps the American population as a whole. In short,
the agency translates research findings from basic science entities
like the National Institutes of Health (NIH) into information that
doctors can use every day in their practices. Another key function of
the agency is to support research on the conditions that affect most
Americans.
AHRQ Translates Research into Everyday Practice
Congress has provided billions of dollars to the National
Institutes of Health, which has resulted in important insights in
preventing and curing major diseases. AHRQ takes this basic science and
produces information that physicians can use every day in their
practices. AHRQ also distributes this information throughout the health
care system. In short, AHRQ is the link between research and the
patient care that Americans receive.
For example, research shows that that beta blockers reduce
mortality. AHRQ supported research to help physicians determine which
patients with heart attacks would benefit from this medication.
AHRQ Supports Research on Conditions Affecting Most Americans
Most typical Americans get their medical care in doctors' offices
and clinics. However, most medical research comes from the study of
extremely ill patients in hospitals
AHRQ studies and supports research on the types of illness that
trouble most people. In brief, AHRQ looks at the problems that bring
people to their doctors every day--not the problems that send them to
the hospital.
For example, AHRQ supported research that found older
antidepressant drugs are as effective as new antidepressant medications
in treating depression, a condition that affects millions of Americans.
Provisions in the Medicare Modernization Act
In addition, the new Medicare law also directs the agency to study
the ``clinical effectiveness and appropriateness of specified health
services and treatments.'' While the law authorizes $50 million for
this effort, the Academy supports the $75 million figure that is
included in the Senate budget resolution.
Moreover, the law asks the agency to establish a new ``Citizens'
Health Care Working Group,'' to initiate a nationwide public debate
about improving the health care system with the goal of providing every
America high quality and affordable health care coverage. The AAFP also
supports funding for this new commission.
RURAL HEALTH PROGRAMS
Continued funding for rural programs is vital to provide adequate
health care services to America's rural citizens. We support the
Federal Office of Rural Health Policy; Area Health Education Centers;
the Community and Migrant Health Center Program; and the NHSC. State
rural health offices, funded through the National Health Services Corps
budget, help states implement these programs so that rural residents
benefit as much as urban patients.
CONCLUSION
The Academy urges Congress to increase funding for Section 747
family medicine training (the Advisory Committee on Training in Primary
Care Medicine and Dentistry $198 million for Section 747); $443 million
for AHRQ and support for rural health programs. Federal support is
vital to sustain and improve America's health care system.
______
Prepared Statement of the Tri-Council for Nursing
The Tri-Council for Nursing appreciates the opportunity to comment
on fiscal year 2005 appropriations for nursing programs. The Tri-
Council for Nursing is an alliance of four national nursing
organizations--the American Association of Colleges of Nursing (AACN),
the American Nurses Association (ANA), the American Organization of
Nurse Executives (AONE), and the National League for Nursing (NLN). The
Tri-Council is focused on leadership and excellence in nursing.
Together, we represent the breadth and scope of nursing; including
practicing nurses, nurse executives, nurse educators, and nurse
researchers.
The Tri-Council gratefully acknowledges this Subcommittee's support
for nursing education and research. We appreciate your continued
recognition of the important role nurses play in the delivery of health
care services and the increased need to fund nursing education
programs, nursing research, and innovative practice models.
Unfortunately, the nursing shortage continues to worsen, therefore we
are again urging you to invest in nursing.
Today, the burgeoning nursing shortage is impacting health care
delivery throughout the nation. The increasing health care demands of
the aging U.S. population and changes in the nurse workforce have
combined to create a shortage unlike any other. A fundamental shift has
occurred in the registered nurse (RN) workforce over the last two
decades. As occupational opportunities for young women have expanded,
and the changing health care environment has increased stresses on
nursing, the number of young people entering nursing has declined. The
lack of young people in nursing has resulted in a steady and dramatic
increase in the average age of the U.S. nurse. Today, the average
working RN is over 43 years old. The average nurse educator is over 50
years old.
This shortage is growing just as the need for nursing services is
mounting. America's demand for nursing care is expected to balloon over
the next 20 years as a result of the aging of the population, advances
in technology, and various economic and policy factors. On February 11,
2004, the Bureau of Labor Statistics reported that registered nursing
will have the greatest job growth of all U.S. professions in the time
period spanning 2002-2012. During this ten-year period, health care
facilities will need to fill more than 1.1 million RN job openings. The
Division of Nursing at the Health Resources and Services Administration
projects that, absent aggressive intervention, the supply of nurses in
America will fall 29 percent below requirements by the year 2020.
The nursing shortage is already having a detrimental impact on the
health care system. Numerous recent studies have shown that nursing
shortages contribute to medical errors, poor patient outcomes, and
increased mortality rates. A study published in the May 30, 2002, New
England Journal of Medicine reported that higher levels of nursing care
correlate with better patient care. And a Joint Commission on the
Accreditation of Healthcare Organizations (JCAHO) study published in
2002 shows that nearly one-quarter of all unanticipated deaths or
injuries result from nurse shortages. Another study published in the
October 23, 2002 Journal of the American Medical Association found that
among the surgical patients studied, there was a pronounced correlation
between nursing shortages and both patient mortality and failure to
rescue.
This growing nursing shortage has effects well beyond domestic
health care. Nurses are integral in everything from adequate terrorism
preparedness, to veterans' health delivery, to disaster response. In
addition, the activation of military reserves is drawing nurses out of
the domestic labor market. Therefore, this shortage threatens our very
strength as a nation.
NURSING WORKFORCE DEVELOPMENT
Federal support for Nursing Workforce Development in Title VIII of
the Public Health Service Act (PHSA) is unduplicated and essential.
Recognizing the impact of the nursing shortage, the 107th Congress took
the visionary step of passing the Nurse Reinvestment Act (Public Law
107-205). This law improved the programs of Title VIII to meet the
unique characteristics of today's shortage. It contained public service
announcements, geriatric training grants, and a nurse faculty loan
repayment program. It also expanded existing programs in Title VIII to
include a scholarship program, career ladder programs, and retention
grants for enhancing patient care delivery systems.
In fiscal year 2004, the hard work of this Subcommittee resulted in
$142 million in funding for Title VIII programs. We strongly urge you
to increase funding for Title VIII programs by at least $63 million to
a total of $205 million in fiscal year 2005. The Tri-Council believes
that the need for this increase is borne out by the HRSA information
for 2003 indicating that only 2 percent of the applications for nursing
scholarships were funded, and a mere 8 percent of the nurse education
loan repayments were funded.
The Title VIII authorities are:
Nurse Education, Practice, and Retention Grants
This section, formerly known as the Basic Nurse Education and
Practice, was expanded and reorganized by the Nurse Reinvestment Act.
Education grant areas were reorganized to include: expanding
enrollments in baccalaureate nursing programs; developing internship
and residency programs to enhance mentoring and specialty training; and
providing new technologies in education including distance learning.
Practice grant areas include: expanding practice arrangements in
non-institutional settings to improve primary health care in medically
underserved communities; providing care for underserved populations
such as the elderly, HIV/AIDS patients, substance abusers, homeless,
and domestic abuse victims; providing skills necessary to practice in
existing and emerging health systems; and developing cultural
competencies.
Retention grant areas include career ladders and improved patient
care delivery systems. The career ladders program supports education
programs designed to assist individuals in obtaining clinical and
theoretical education required to enter the profession, and to promote
career advancement within nursing. In fiscal year 2003, HRSA received
301 applications for career ladder grants. Unfortunately, funding
levels allowed HRSA to award a total of 12 grants.
Enhancing patient care delivery system grants encourage nurses to
remain in patient care by providing grants to facilities to enhance
collaboration and communication among nurses and other health care
professionals, and to promote nurse involvement in the organizational
and clinical decision-making processes of a health care facility. Best
practices for these nurse administration programs have been identified
by the American Nurse Credentialing Center's Magnet Recognition
Program. These best practices have been shown to double nurse retention
rates, increase nurse satisfaction, and improve patient care. In fiscal
year 2003, HRSA received 122 applications for enhanced patient care
delivery systems; HRSA was able to fund 14.
Nurse Education, Practice, and Retention Grants received $31.8
million in fiscal year 2004 appropriations.
National Nurse Service Corps
The nurse service corps is comprised of a loan repayment program
and a scholarship program, the Secretary of HHS has the authority to
allocate funds between the two areas. The Nurse Education Loan
Repayment Program (NELRP) repays nursing student loans in return for at
least 2 years of practice in a facility with a critical nursing
shortage. For the first 2 years of service, the NELRP will repay 60
percent of the RN's student loan balance. If the nurse elects to stay
for another year, an additional 25 percent of the loan will be repaid.
Within 3 years, a nurse can pay off 85 percent of his/her student
loans.
The NELRP has benefited from the support of this Subcommittee, as
well as the administration. It boasts a proven track record of
delivering nurses to facilities hardest hit by the nursing shortage.
HRSA has given NELRP funding preference to skilled nursing facilities,
disproportionate share hospitals, and departments of public health.
However, lack of funding has hindered the full implementation of this
program. In fiscal year 2003, HRSA received more than 8,300
applications for the NELRP. Due to lack of funding, only 602 loan
repayments were awarded. Therefore, 92 percent of the nurses willing to
immediately begin practicing in facilities hardest hit by the shortage
were turned away from this program.
The nursing scholarship program offers funds to nursing students
who, upon graduation, agree to work for at least 2 years in a health
care facility with a critical shortage of nurses. Preference is given
to students with the greatest financial need. Like the loan repayment
program, the nursing scholarship program as been stunted by a lack of
funding. For fiscal year 2003, HRSA received more than 4,500
applications for the nursing scholarship. Due to lack of funding, a
mere 94 scholarships were awarded. Therefore, 98 percent of the nursing
students willing to work in facilities with a critical shortage of
nurses were also denied access to the corps.
The National Nurse Service Corps received $26.7 million in fiscal
year 2004 appropriations.
Nurse Faculty Loan Program
This program establishes a loan repayment fund within schools of
nursing to increase the number of qualified nurse faculty. Nurses may
pursue a master's or doctoral degree. They must agree to teach at a
school of nursing in exchange for cancellation of up to 85 percent of
their educational loans, plus interest, over a 4-year period. Loans may
cover the costs of tuition, fees, books, laboratory expenses, and other
reasonable education expenses.
This program is critical given the worsening shortage of nursing
faculty. Last year, schools of nursing were forced to turn away tens of
thousands of qualified applicants due largely to the lack of faculty.
In fiscal year 2003, HRSA awarded 55 nurse faculty loan repayments.
The Nurse Faculty Loan Program received $4.9 million in fiscal year
2004 appropriations.
Nursing Workforce Diversity
This program provides funds to enhance diversity in nursing
education and practice. It supports projects to increase nursing
education opportunities for individuals from disadvantaged
backgrounds--including racial and ethnic minorities, as well as
individuals who are economically disadvantaged. Racial and ethnic
minorities currently comprise more than 25 percent of the nation's
population and will comprise nearly 40 percent by the year 2020. Only
12 percent of the RNs in the United States come from diverse
backgrounds. Increasing the number of RNs from diverse races and
cultures allows them to address the prevention, treatment, and
rehabilitation needs of an increasingly diverse population. For fiscal
year 2003, HRSA received 122 submissions for nursing workforce
diversity grants. HRSA was only able to fund 20.
Nursing Workforce Diversity received $16.4 million in fiscal year
2004 appropriations.
Advanced Nurse Education
Advanced practice registered nurses (APRNs) are registered nurses
(RNs) who have attained advanced expertise in the clinical management
of health conditions. Typically, an APRN holds a master's degree with
advanced didactic and clinical preparation beyond that of the RN. Most
have practice experience as RNs prior to entering graduate school.
Practice areas include, but are not limited to: anesthesiology, family
medicine, gerontology, pediatrics, mental health, midwifery,
neonatology, and women's & adult health. Title VIII grants have
supported the development of virtually all initial state and regional
outreach models using distance learning methodologies to provide
advanced study opportunities for nurses in rural and remote areas.
These grants also provide traineeships for masters and doctoral
students. Title VIII funds more than 60 percent of U.S. nurse
practitioner (NP) education programs and assists 83 percent of nurse
midwifery programs. Over 45 percent of advanced nursing graduates go on
to practice in medically underserved communities, and in areas with
large Medicaid populations. Many provide care to minority or
disadvantaged patients. In fiscal year 2003, HRSA funded 35 advanced
education nursing grants, 335 advanced education nursing traineeships,
and 69 nurse anesthetist traineeships.
Advanced Education Nursing received $58.6 million in fiscal year
2004 appropriations.
Comprehensive Geriatric Education Grants
This authority awards grants to train and educate nurses in
providing health care to the elderly. Funds are used to train
individuals who provide direct care for the elderly, to develop and
disseminate geriatric nursing curriculum, to train faculty members in
geriatrics, and to provide continuing education to nurses who provide
geriatric care. The growing number of elderly Americans and the
impending health care needs of the baby boom generation make this
program critically important. In fiscal year 2003, HRSA received 92
applications for the comprehensive geriatric training program, 17
grants were funded.
Comprehensive Geriatric Education Grants received $3.5 million in
fiscal year 2004 appropriations.
NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)
The Tri-Council also urges the Subcommittee to increase funding for
the NINR, one of the institutes at the National Institutes of Health
(NIH). Nursing research is an integral part of the effectiveness of
nursing care. Advances in nursing care arising from nursing and other
biomedical research improves the quality of patient care and has shown
excellent progress in reducing health care costs. Research programs
supported by the NINR address a number of critical public health and
patient care questions. The research is driven by real and immediate
problems encountered by patients and families. Study results offer the
clear prospect of improving health, reducing morbidity and mortality,
and lowering costs and demand for health care.
Recent studies have focused on the effects of hospital
restructuring, such as changes in nurse staffing, on patient care; the
incidence and risk factors for uterine rupture in pregnancies following
cesarean section; and the means to help family caregivers provide high-
quality long, term care for loved ones with chronic health care needs.
In addition, NINR is leading the NIH research on end-of-life and
palliative care. The NINR is the second-lowest funded institute at NIH
and provides vital health care research for the nursing community. The
Tri-Council recommends increasing funding for the NINR in fiscal year
2005.
CONCLUSION
While the Tri-Council is encouraged by a recent resurgence of
interest in the nursing profession, we are concerned by the fact that
Title VIII funding levels have not been sufficient to assist qualified
students enter the nursing profession. The nursing shortage will
continue to worsen if significant investments are not made in nursing
workforce development programs. Recent efforts have shown that
aggressive and innovative recruitment efforts can help avert the
impending nursing shortage--if they are adequately funded.
Thirty one years ago, this committee invested $153.6 million in the
fiscal year 1974 programs of Title VIII. Inflated to today's dollars,
this long-ago appropriation would equal $574 million (more than four
times the fiscal year 2004 appropriation). Today's shortage is more
dire and systemic than that of the 1970's. The Tri-Council asks you to
meet today's shortage with a relatively modest investment of $205
million in Title VIII programs. Additionally, an investment in the NINR
will help assure that these nurses are equipped with the information
needed to provide the best care possible.
______
Prepared Statement of the National Area Health Education Centers
Organization
SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS
--Increase funding for the health professions and nursing education
programs under Title VII and Title VIII of the Public Health
Service Act to at least $550 million for fiscal year 2005.
--Restore funding for Area Health Education Centers (AHECs) to fiscal
year 2003 level of $33.1 million.
--Restore funding for Health Education Training Centers (HETCs) to
fiscal year 2003 level of $4.3 million.
Mr. Chairman, and members of the subcommittee, I am pleased to
present this testimony on behalf of the National AHEC Organization
(NAO).
By way of brief introduction, my name is Linda Kanzleiter. I am an
Assistant Professor at the Pennsylvania State University College of
Medicine and the Associate Director for the dual state Pennsylvania-
Delaware Area Health Education Center Program (PA-DEL AHEC).
As a member of NAO, the professional organization representing the
national network of Area Health Education Center Programs (AHECs) and
Health Education Center Programs (HETCs), I come to you today to
demonstrate the AHEC/HETC network as a well-established national system
of community and academic partnerships that increases access to quality
health care services for our nation, especially the growing number of
uninsured and underinsured populations by improving the supply and
distribution of our health professions workforce.
Three essential strategies were developed: the Neighborhood Health
Centers, later to be named Community Health Centers (1964); the
National Health Service Corps (NHSC) established in 1970; and the
Carnegie Commissions Report establishing the AHEC program (1970) and
HETC program, established for Border and non-border areas (1989). The
three programs were created in different acts and at different times,
but were brought together within the Public Health Service within a 3-
year period.
The Community Health Centers are dedicated to providing
preventative and ambulatory health care to the most uninsured and
underinsured populations by placing point-of-service facilities in
these areas; and the NHSC is committed to placing health professionals
to the areas which have the most difficult time recruiting and
retaining health professionals. However, it is the AHEC & HETC
organization that recruits, trains and retains a health professions
workforce committed to working with the underserved. This goal is
accomplished through bridging the resources of academia to communities.
THE NATIONAL AHEC AND HETC ORGANIZATION
The effectiveness of the AHEC & HETC organization rests with its
community and academic leadership, collaborative practices and
committed partnerships of numerous community-based organizations
representing 48 AHEC & HETC programs, which direct 180 centers housed
in 43 states.
Fundamental to the health care infrastructure of the nation is the
recruitment and retention of a qualified health professions workforce.
The strategic functions of the AHEC & HETC programs is to facilitate
the recruitment and retention of the current and future health care
professions workforce as a means to increase access to health care
services, and to provide a vehicle to access community-based and
academic-based health professionals integral to the promotion,
development, dissemination and management of public and community
health issues. Claude Earl Fox, former Administrator of HRSA, said it
so well: ``AHEC programs are a catalyst in both the communities they
bridge--spurring the academic enterprise to attend to the needs of the
underserved people--and sparking the community of people served to
involve themselves in the training of health professionals. This is a
necessary first step in addressing the health needs of any community.''
The strength of the national AHEC & HETC organization is their
cultural diversity and scope of work. The key functions of the AHEC &
HETC network rests with access and building capacity, which:
--Creates community-based education and training networks that are
developed through linking health professionals and their
practices in underserved areas with academic centers and
programs to create clinical training experiences for primary
care residents, medical students, dental medicine students,
nurse practitioners, physician assistants, nurses and other
allied health students.
--Recruits practitioners from the incumbent health professions
workforce to medically underserved communities through
established recruitment programs and special placement
opportunities. Special re-entry programs offered to retrain
nurses and other health careers for return to the workforce,
and job re-training offered to adult learners interested in
developing a career ladder or career change.
--Retains practitioners working with disenfranchised populations and
medically underserved communities through innovative and
traditional continuing medical education programs, building
linkages between the community practitioners and academic
centers, providing telemedicine initiatives and self directed
educational modules to maintain knowledge and skills of health
professionals, and fostering telemedicine programs for clinical
consultation in some areas.
--Prepares interested primary and secondary students from rural,
urban and cultural diverse communities for college and/or
career programs in the health professions through academic
readiness programs. With a cultural and ethnic diversity
blending the nation, emphasis is placed on preparing under-
represented minority students into the health careers through
science, math, and English preparatory programs.
--Retains the commitment of high school students, medical students,
health professions students and residents through the pipeline
of health professions education and training through selective
mentoring, shadowing and special interest programs.
--Builds capacity within the health care community to address
community and public health issues such as bioterrorism,
Healthy People 2010 objectives.
THE PA-DE AHEC PROGRAM
The PA-DE AHEC Program is celebrating its 10th Anniversary this
year. Although Delaware is new to the Commonwealth's and national AHEC
organization, the leadership of the Delaware region brings an in-depth
understanding of its state's health professions needs and a commitment
to the mission of the national organization and Pennsylvania AHEC
program.
The PA-DE AHEC Program houses an innovative dual state system that
integrates and bridges academic centers with communities to strengthen
and increase access:
--To health care services, especially in underserved communities,
--To communities and health care personnel integral to the public
health infrastructure,
--To the academic and community-based health professions workforce,
--To the vital educational resources required to maintain the skills
and knowledge of those vested with safe-guarding the health of
Pennsylvania and Delaware,
--To the primary and secondary educational systems fostering
interests in health careers, especially for cultural and
ethically diverse schools students,
--To the medical, dental and mental health practice communities
facilitating and responding to community and public concerns.
THE PA-DE AHEC ORGANIZATION
The PA-DE AHEC Program has developed a dual state infrastructure
that includes: the University of Pittsburgh Schools of Medicine,
Nursing, Dentistry, Pharmacy and Public Health; the Pennsylvania State
University College of Medicine, School of Nursing and Agromedicine
Program; the Philadelphia College of Osteopathic Medicine; Temple
University Schools of Medicine, Pharmacy, Nursing and Dentistry; Thomas
Jefferson University, Jefferson Medical College and College of Nursing;
Drexel University School of Medicine, University of Pennsylvania School
of Dental Medicine and Midwifery Program, and Delaware University,
School of Nursing.
Our medical education and training infrastructure also includes
over 90 health science institutions, and a community-based teaching
network of over 1,000 physicians and health professionals representing
12 medical, oral and public health disciplines, and numerous community
organizations inclusive of Pennsylvania's 67 counties and Delaware's
three counties.
About Pennsylvania and Delaware
Pennsylvania and Delaware, like the rest of the nation, share the
problem of mal-distribution of health care providers and limited access
to essential health care services. Pennsylvania houses a population of
over 12 million people within a geographic range of 46,000 square
miles, and supports one of the largest aging populations in the nation.
Traditional market forces have not been very effective in making health
care available to rural and inner city residents. It is estimated that
21 percent or greater have no health care coverage and a significant
proportion remain underinsured. Primary care access and provider
shortage in the state have resulted in areas of 55 of 67 counties being
designated as Health Professional Shortage Areas (HPSA), Medically
Underserved Areas (MUA) or both. Dental Health Professions Shortage
Areas and Mental Health Shortage Areas are representative of an
increased number of counties without oral and mental health services.
Increasing Access to Health Care
The PA-DE AHEC has facilitated placement of over 31,000 students,
representing 78,500 clinical training weeks. These students are
primarily recruited to train in underserved communities. Working with
51 community health centers, federally qualified centers, and NHSC
designated centers, the PA-DE AHEC fosters clinical training
experiences that teach students the rewards and challenges of working
with at-risk populations and the special knowledge and skills required
to provide quality health care in communities with limited resources.
HEALTH PROFESSIONS RECRUITMENT AND RETENTION
Promoting the NHSC and State Loan Repayment and Scholarship
programs are important first steps to introducing providers to
Pennsylvania and Delaware. Developing and implementing math, science
and English programs for students in disadvantaged school districts
facilitates entrance into the health careers through a Grow Your Own
approach to the health professions crisis. Special initiatives are also
promoted in areas of nursing with re-entry programs (refresher courses
for licensed nurses not practicing for five or more years), retraining
programs that offer promotional and career advancement, and remedial
programs that are targeted to the special adult learner seeking
admission to the health careers. All AHEC regions look to facilitate
nursing programs focused on recruitment, re-entry, retraining and
retention initiatives.
In addition, the PA-DE AHEC Program provides self-directed study
programs as way for practitioners to access continuing professional
education programs in respect to the increasing professional and
practice demands of their office and community. For example the most
recent program, PA-DE AHEC is offering a self-directed learning program
on the screening, diagnosing and treatment of endocrine disease,
psychiatric disorders and co-morbidity. Web-based learning in areas of
tobacco cessation and tobacco cessation pharmacopeias are also venues
of self directed programs. In addition, statewide satellite broadcasts
with capabilities to over 520 down link sites within the system add
another venue for continuing professional education.
PUBLIC HEALTH INFRASTRUCTURE
Responding to the national, state and local needs of preparedness
teams and public health workers, the PA-DE AHEC Program is an integral
partner to the emerging public health infrastructure. The PA-DE AHEC
provides, through its academic and community partnerships, program
development as well as critical access to communities, at-risk
populations and the health professions workforce for emerging public
health issues, such as bioterrorism preparedness training to health
professionals, especially to agricultural and migrant communities. In
addition we work with public health officials in areas of health
promotion and disease prevention programs, which focus on minority
health disparities and cultural sensitivity training for safety net
providers. Many community and public health programs are also delivered
to respond to the Healthy People 2010 objectives.
CRITICAL WORKFORCE ISSUES
Regardless of the 30 years of well-intended efforts by countless
health professionals and policy makers, the nation's health care
``safety net'' program is not able to meet the growing health care
needs of the country's uninsured and underinsured populations. Young
adults no longer see clinical nursing as an acceptable career path, In
fact, other health professions are at-risk; pharmacy is another
example. Rural hospitals and health systems are also closing
frequently; which adds another dimension to limiting access to health
care services. The impact of hospital and system closures contributes
to the unemployment rate in local communities and decreases the
economic base. This fractured health care system looks to address the
health care needs of an aging nation, which requires much of its health
professions workforce.
Pennsylvania and Delaware are faced with similar concerns. Only 13
percent of Pennsylvania primary care physician workforce practice in
rural areas. Furthermore, 25 percent of primary care physicians in the
Commonwealth are 55 or older indicating a large number of potential
retirees. Equally troublesome is documentation indicating that 20
percent will leave primary care practice in the state because of lack
of practice coverage, reimbursement issues, lack of technology in rural
areas, and professional isolation. Time is of the essence, and the
important message is that AHEC is the foundation for recruiting,
retaining and distributing a health professions workforce for the
nation.
Mr. Chairman, I respectfully ask the Subcommittee to support our
recommendation to increase funding for the Health Professions and
Nursing Education programs under Title VII and Title VIII of the Public
Health Service Act to a minimum of $550 million for fiscal year 2005.
Our recommendations are consistent with those of the Health Professions
and Nursing Coalition.
______
Prepared Statement of the National League for Nursing
The National League for Nursing (NLN)--representing more than 1,300
schools of nursing, 14,000 faculty and individual members, and 18
constituent leagues--appreciates the Subcommittee's past support for
nursing education and your continued recognition of the important role
nurses play in the delivery of our nation's health care services. NLN
is concerned, however, that the advancements made by Congress to help
alleviate the nursing shortage will be lost during the fiscal year 2005
appropriations process unless additional resources are expended. We
urge your continued support for Title VIII--Nursing Workforce
Development Programs by ensuring that these programs are funded at a
minimum level of $205 million for fiscal year 2005.
Today's nursing shortage is very real and very different from any
experienced in the past. The new nursing shortage is evidenced by an
aging workforce; acute nursing shortages in certain geographic areas;
and a shortage of nurses and nurse educators adequately prepared to
meet patient need in a changing health care environment. As a result,
the supply of appropriately prepared nurses and nursing faculty is
inadequate to meet the needs of a diverse population. This shortfall
will grow more serious over the next 5 years.
Congress did an admirable job of passing the Nurse Reinvestment Act
in 2002. The new monies used to fund loans and scholarships are
appreciated. However, it has become abundantly clear that significantly
more funding is required to meet the existing need. In fiscal year
2003, for example, only 55 nurse faculty loans were awarded. Yet last
year, schools of nursing were forced to turn away 29,284 qualified
nursing students because of a lack of prepared nurse educators to teach
them. This number is significantly greater than the 18,476 students who
were turned away in 2002.
Schools of nursing are suffering from a continuing and growing
shortage of faculty, which prevents these institutions from admitting
many qualified students who are applying to their programs. NLN's 2002
Faculty Survey concludes that not enough qualified nurse educators
exist to teach the number of nurses needed to ameliorate the nursing
shortage. According to the Survey, this situation is not expected to
improve in the near future, since an adequate number of nurse educators
are currently not in the education pipeline.
The NLN Survey found three trends impacting the future of nursing
education over the next decade:
The aging of the nurse faculty population
An average of 1.3 full-time faculty members per program left their
positions in nursing education in 2002. About half the Survey
respondents had at least one unfilled budgeted full-time faculty
position and some have as many as 15 such positions.
Approximately 1,800 full-time faculty members leave their positions
each year. About 10,000 master's level nurses graduate per year, 15
percent of whom would have to go into teaching just to maintain the
status quo. Since this is highly unlikely, the gap between unfilled
positions and the candidate pool will widen significantly.
The increasing number of part-time faculty
The number of part-time faculty has increased since 1996--nearly 17
percent in baccalaureate programs and 14 percent in associate degree
programs. Approximately 23 percent of the estimated number of faculty
FTEs is now provided by part-time faculty.
Part time employees are often not an integral part of the design,
implementation, and evaluation of the overall nursing education
program. Many may hold other positions that often limit their
availability to students. Further, many part-time faculty have not been
prepared for the faculty role.
The large number of nursing faculty who are not prepared at the
doctoral level
Approximately half the full-time faculty in baccalaureate and
higher degree programs holds a doctoral degree. In associate degree
programs, doctorally-prepared faculty account for only 6.6 percent and
the number is slightly more than 5 percent in diploma programs. Only
350 to 400 nursing students receive doctoral degrees each year and the
pool of doctorally-prepared candidates for full-time nursing
professorships is very limited.
Educators without doctoral degrees may lack credibility within a
university setting and have limited opportunities to assume leadership
positions. Institutions with low numbers of doctorally-prepared
educators may be less likely to get funds to support research or
educational innovations.
As important as educational incentives for future practicing nurses
are the scholarships for doctoral students, who will instruct the next
generation of nurses. Please do not allow us to lose ground in the
fight against the nursing shortage--fund Title VIII nursing programs at
a level commensurate with the severity of the health care crisis facing
the nation today.
Your support will help ensure that nurses exist in the future who
are prepared and qualified to take care of you, your family, and all
those in this country who will need our care. If you have any questions
about NLN's position or we can be of further assistance to you, please
feel free to contact Kathleen Ream, NLN Manager of Government Affairs,
at 703-241-3974.
______
Prepared Statement of the National Association of Children's Hospitals
The National Association of Children's Hospitals (N.A.C.H.) is
pleased to have the opportunity to submit the following statement for
the hearing record in support of the Children's Hospitals' Graduate
Medical Education (CHGME) Payment Program in the Health Resources and
Services Administration (HRSA).
On behalf of the nation's 60 independent children's teaching
hospitals, we thank the Subcommittee for the remarkable achievement
that Congress made last year in continuing to provide full, equitable
GME funding for these hospitals, giving them a level of federal support
for their teaching programs that is comparable to what all other
teaching hospitals receive through Medicare. We urge the Subcommittee
to continue to provide equitable funding for Children's Hospitals GME
in fiscal year 2005 so that these institutions will have the resources
to train and educate the nation's pediatric workforce.
N.A.C.H. is a not-for-profit trade association, representing more
than 120 children's hospitals across the country. Its members include
independent acute care children's hospitals, acute care children's
hospitals organized within larger medical centers, and independent
children's specialty and rehabilitation hospitals.
N.A.C.H. seeks to serve its member hospitals' ability to fulfill
their four-fold missions of clinical care, education, research, and
advocacy devoted to the health and well being of all of the children in
their communities. Children's hospitals are regional and national
centers of excellence for children with serious and complex conditions.
They are centers of biomedical and health services research for
children, and they serve as the major training centers for future
pediatric researchers, as well as a significant number of our
children's doctors. These institutions are major safety net providers,
serving a disproportionate share of children of low-income families,
and they are also advocates for the public health of all children.
BACKGROUND: THE NEED FOR CHILDREN'S HOSPITALS GME
While they account for less than 1 percent of all hospitals, the
independent children's hospitals train nearly 30 percent of all
pediatricians, half of all pediatric specialists, and a majority of
future pediatric researchers. They also provide required pediatric
rotations for many other residents. They train about 4,000 residents
annually, and the need for these programs is even more heightened by
the growing evidence of shortages of pediatric specialists around the
country.
Prior to initial funding of the CHGME program for fiscal year 2000,
these hospitals were facing enormous challenges to their ability to
maintain their training programs. The increasingly price competitive
medical marketplace was resulting in more and more payers not covering
the costs of care, including the costs associated with teaching.
The independent children's hospitals were essentially left out of
what had become the one major source of GME financing for other
teaching hospitals--Medicare--because they see few if any Medicare
patients. They received only 1/200th (or less than 0.5 percent) of the
federal support that all other teaching hospitals received under
Medicare. This lack of GME financing, combined with the financial
challenges stemming from their other missions, was threatening their
teaching programs, as well as other important services.
In addition to their teaching missions, the independent children's
hospitals are a significant part of the health care safety net for low-
income children. On average, they devote nearly half of their patient
care to children who are assisted by Medicaid or are uninsured. More
than 40 percent of their care is for children assisted by Medicaid, and
Medicaid covers only about 84 percent of the cost of that care. Without
the Medicaid disproportionate share hospital (DSH) payments, Medicaid
would cover only about 76 percent of children's hospitals' patient care
costs. Further, these hospitals provide many important services from
dental care to child abuse programs that are either uncovered or very
underpaid.
The independent children's hospitals also are essential to the
provision of care for seriously and chronically ill children in this
country. They devote more than 75 percent of their care for children
with one or more chronic or congenital conditions. They provide more
than 40 percent to 75 percent of the inpatient care to children with
many serious illnesses--from children with cancer or cerebral palsy,
for example, to children needing heart surgery or organ transplants. In
some regions, they are the only source of pediatric specialty care. The
severity and complexity of illness and the services and resources that
these institutions must maintain to assure access to this quality care
for all children are also often inadequately reimbursed.
The CHGME program, and its relatively quick progress to full
funding in fiscal year 2002, came at a critical time. Between 1997 and
2000, independent children's hospitals on average experienced declining
operating margins and total margins. By fiscal year 2000 more than a
quarter of the hospitals were not able to cover their operating costs
with operating revenues, and nearly 20 percent were not able to cover
their total costs with total revenues. Thanks to the CHGME program,
these hospitals have been able to maintain and strengthen their
training programs.
Continuing this critical CHGME funding is more important for these
hospitals than ever in light of state budget shortfalls in many states
and the resulting pressures for significant reductions in state
Medicaid programs. Because children's hospitals devote such a
substantial portion of their care to children of low-income families,
they are especially affected by cutbacks in state Medicaid programs.
The pediatric community, including the American Academy of
Pediatrics, Association of Medical School Pediatric Department Chairs,
and others, has recognized the critical importance of the GME programs
of the independent children's teaching hospitals, not only to the
future of the individual hospitals and their essential services but
also to the future of the nation's pediatric workforce and the
provision of children's health care and advancements in pediatric
medicine overall.
Lastly, many of the independent children's hospitals are a vital
part of the emergency and critical care services in their communities
and regions. They are part of the emergency response system that must
be in place for bioterrorism other public health emergencies. Expenses
associated with preparedness will add to their continuing costs in
meeting children's needs.
CONGRESSIONAL RESPONSE
In the absence of any movement towards broader GME financing
reform, Congress in 1999 authorized the Children's Hospitals' GME
discretionary grant program to address the existing inequity in GME
financing for the independent children's hospitals and ensure that
these institutions could receive equitable federal support to sustain
their teaching programs. The legislation was reauthorized in 2000
through fiscal year 2005 and provided for $285 million through fiscal
year 2001 and such sums as may be necessary in the years beyond.\1\
Congress passed both the initial authorization (as part of the
``Healthcare Research and Quality Act of 1999'') and the
reauthorization (as part of the ``Children's Health Act of 2000'').
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\1\ The Lewin Group, an independent health policy analysis firm
calculated in 1998 that independent children's teaching hospitals
should receive approximately $285 million in federal GME support for
nearly 60 institutions to achieve parity with the financial
compensation provided through Medicare for GME support to other
teaching hospitals.
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With the support of this Subcommittee, Congress appropriated
initial funding for the program in fiscal year 2000, before the
enactment of its authorization. Following that enactment, Congress
moved substantially toward full funding for the program in fiscal year
2001 and completed that goal, providing $285 million in fiscal year
2002, $290 million in fiscal year 2003, and $303 million in fiscal year
2004. This represents an extraordinary achievement for the future of
children's health care as well as for the nation's independent
children's teaching hospitals.
The $285 million appropriated in fiscal year 2002 was distributed
at the end of the fiscal year through HRSA to 59 children's hospitals
according to a formula based on the number and type of full-time
equivalent (FTE) residents trained, in accordance with Medicare rules
as well as the complexity of care and intensity of teaching the
hospitals provide. Consistent with the authorizing legislation, HRSA
allocates the annual appropriation in bi-weekly periodic payments to
eligible independent children's hospitals.
FISCAL YEAR 2005 REQUEST
N.A.C.H. respectfully requests that the Subcommittee continue
equitable GME funding for the independent children's hospitals by
providing $303 million for the program in fiscal year 2005--the level
of funding requested by President Bush and equal to the fiscal year
2004 appropriation enacted in January 2004. We are grateful for the
administration's recognition of the significance of the CHGME program.
Adequate, equitable funding for CHGME is an ongoing need.
Children's hospitals continue to train new pediatric residents and
researchers every year. Children's hospitals have appreciated very much
the congressional support they have received, including the attainment
of the program's authorization in fiscal year 2002 and continuation of
full funding with an inflation adjustment in fiscal year 2003 and
fiscal year 2004. Now, N.A.C.H. asks Congress to maintain this progress
by enactment of the President's request.
Support for a strong investment in GME at independent children's
teaching hospitals is consistent with the repeated concern the
Subcommittee has expressed for the health and well being of our
nation's children--through education, health, and social welfare
programs. It also is consistent with the Subcommittee's repeated
emphasis on the importance of enhanced investment in the National
Institutes of Health (NIH) overall, and in NIH support for pediatric
research in particular, for which we are very grateful.
The CHGME funding has been essential to the ability of the
independent children's hospitals to sustain their GME programs. At the
same time, it has enabled them to do so without sacrificing support for
other critically important services that also rely on hospital subsidy,
such as many specialty and critical care services, child abuse
prevention and treatment services, poison control centers, services to
low-income children who have inadequate or no coverage, mental health
and dental services, and community advocacy, such as immunization and
motor vehicle safety campaigns.
In recommending an fiscal year 2005 appropriation of $303 million
for CHGME, the Bush administration specifically cited the both the
program's clear purpose and its impact on the financial health of
children's hospitals.
In conclusion, the Children's Hospitals GME Payment Program is an
invaluable investment in children's health. The future of the pediatric
workforce and children's access to quality pediatric care, including
specialty and critical care services, could not be assured without it.
Again, N.A.C.H. thanks this Subcommittee and Congress for your
continuing leadership and support.
For further information, please contact Peters D. Willson, vice
president for public policy, N.A.C.H., at 703/797-6006 or
[email protected].
______
Prepared Statement of the Community Medical Centers, Fresno, CA
With over 43 million people in the United States lacking health
insurance, the situation is reaching a crisis. National polls of
Americans have ranked affordable health care as a leading concern
behind the economy and jobs, and national security and terrorism. The
issue is of greater concern for those of us who live in the Central San
Joaquin Valley in California.
In the San Joaquin Valley, we face even greater challenges with the
delivery of health care. While the national average for uninsured
hovers around 15 percent, the Central San Joaquin Valleys sees a figure
closer to 20 percent. As the region poises itself to address the
chronic double-digit unemployment (from 14 percent-17 percent) and an
equally high rate of poverty (20 percent-30 percent) through aggressive
economic development and work force training initiatives, we cannot
ignore the need for accessible health care for the uninsured.
The health statistics also point to the need to develop a pro-
active and aggressive approach to the situation. They are:
--The third highest asthma mortality rate in the nation
--The highest incidence of diabetes among the Hispanic population
--The highest rates of teen pregnancy in the state
--The lowest immunization rates in the nation (62 percent at age 2
vs. 79 percent nationally)
--Late or no prenatal care for pregnant women
Community Medical Centers is a $574 million locally owned, not-for-
profit health care corporation based in Fresno, California and is
committed to improving accessibility to health care in the area. As a
result of a landmark decision by the Fresno County Board of Supervisors
in 1996, the County of Fresno and Community Medical Centers embarked
upon a 30-year partnership obligating Community to provide care to the
uninsured and underinsured residents of Fresno County.
Community, along with other health care providers such as Sequoia
Community Health Foundation, a Federally Qualified Health Center, has
been committed to developing a network of outpatient clinics throughout
the county with a hub facility to be located on the campus of the
Regional Medical Center in downtown Fresno. This outpatient clinic is
to be adjacent to the UCSF Fresno Medical Education and Research
Center, which is currently under construction, and in-patient hospital
services as well. It is only by enhancing access to health care through
multiple primary care sites can we begin to address the many health
care needs of a burgeoning population, both young and old.
This Outpatient Care Clinic will serve as a hub to a network of
clinics throughout the County of Fresno housing primary and specialty
care including a children's clinic, a women's clinic focusing on
obstetrical and gynecological needs, asthma treatment and education,
diabetes treatment and education as well as surgical follow-up.
We would like to ask for your assistance in securing $1 million in
funding for the purposes of constructing an outpatient care clinic on
the campus of the Regional Medical Center in Fresno. We understand that
this request would require a special earmark under the Health Resources
Services Administration account in the Labor/Health and Human Services
appropriations bill. We are also aggressively pursuing funding through
multiple private foundations to secure the bulk of the funding for this
$24 million facility. We believe that this facility and a comprehensive
approach to addressing the need for health care services in our region
is the best option to improve the quality of life in the Central San
Joaquin Valley.
______
Prepared Statement of the American Museum of Natural History
ABOUT THE AMERICAN MUSEUM OF NATURAL HISTORY
The American Museum of Natural History [AMNH] is one of the
nation's preeminent institutions for scientific research and public
education. Since its founding in 1869, the Museum has pursued its
mission to ``discover, interpret, and disseminate--through scientific
research and education--knowledge about human cultures, the natural
world, and the universe.'' It is renowned for its exhibitions and
collections, and with nearly four million annual visitors--
approximately half of them children--its audience is one of the
largest, fastest growing, and most diverse of any museum in the
country. Museum scientists conduct groundbreaking research in fields
ranging from all branches of zoology, comparative genomics, and
informatics to earth, space, and environmental sciences and
biodiversity conservation.
Today more than 200 Museum scientists with internationally
recognized expertise, led by 46 curators, conduct laboratory and
collections-based research programs as well as fieldwork and training.
Scientists in five divisions (Anthropology; Earth, Planetary, and Space
Sciences; Invertebrate Zoology; Paleontology; and Vertebrate Zoology)
are documenting changes in the environment, making new discoveries in
the fossil record, and describing human culture in all its variety. In
the Museum's Institute for Comparative Genomics, established in 2001,
researchers are mapping the genomes of non-human organisms as well as
creating new computational tools to retrace the evolutionary tree.
The Museum is also a distinguished training institution, which
serves up to 80 undergraduates, doctoral, and postdoctoral trainees
annually. These training programs support doctoral and postdoctoral
scientists with highly competitive research fellowships, and offer
talented undergraduates an opportunity to work with Museum scientists.
The Museum's doctoral and post-doctoral training program, dating from
1908, is the oldest and largest of any such program at a scientific
museum. The Museum currently has collaborative programs with Yale
University, Columbia University, Cornell University, New York
University, and CUNY. The training encompasses the entire range of
science covered in the Museum's mission, which includes astrophysics,
earth sciences, evolutionary biology, zoology, paleontology,
comparative genomics, biodiversity sciences, and anthropology.
The AMNH collections of some 32 million natural specimens and
cultural artifacts are a major scientific resource, providing the
foundation for the Museum's interrelated research, education, and
exhibition missions. They often include endangered and extinct species
as well as many of the only known ``type specimens,'' or examples of
species by which all other finds are compared. Within the biological
collections are many spectacular individual collections, including the
world's most comprehensive collections of dinosaurs, fossil mammals,
North American butterflies, spiders, Australian and Chinese amphibians,
reptiles, fishes, and one of the world's most important bird
collections. Collections such as these provide vital data for Museum
scientists as well as for more than 250 national and international
visiting scientists each year.
The Museum interprets the work of its scientists, highlights its
collections, addresses current scientific and cultural issues, and
promotes public understanding of science through its renowned permanent
and temporary exhibits (such as the Genomic Revolution in 2001) as well
as its comprehensive education programs. These programs attract more
than 400,000 students and teachers and more than 5,000 educators for
professional development opportunities. The Museum also takes its
resources beyond its walls through the National Center for Science
Literacy, Education, and Technology, launched in 1997 in partnership
with NASA.
COMPARATIVE GENOMICS RESOURCES
The American Museum shares with DHHS a fundamental commitment to
improving the nation's health and education and advancing the research,
training, facilities, and technology that support them. The Museum is
deeply engaged in the area of comparative genomics; a partnership
between the Museum and DHHS/HRSA would further mutual goals for
improving the nation's health and welfare through research and training
in genomic science.
Genomic Science and Training Resources
DHHS leads the nation's health-related research and genome science,
advanced sequencing technologies, instrumentation, and facilities. The
American Museum, in turn, is home to a preeminent molecular biology
research and training program and leads science education and outreach
efforts. In the era of genomics, museum collections have become
critical baseline resources for the assessment of genetic diversity of
natural populations; studying genomic data in a natural history context
makes it possible to more fully understand the impacts of new
discoveries in genomics and molecular biology. Genomes of the simplest
organisms provide a window into the fundamental mechanics of life, and
understanding their natural capabilities can help solve challenges in
biodefense, medicine, and health care. In the Museum's molecular
laboratories, in operation now for 11 years, more than 40 researchers
in molecular systematics, conservation genetics, and developmental
biology conduct genetic research on a variety of study organisms. The
labs also nourish the Museum's distinguished training programs that
serve up to 80 undergraduates, doctoral, and postdoctoral trainees
annually.
Frozen Tissue Collection
The Museum offers unique resources in support of its molecular
program. These include an expansion of its collections to include
biological tissues and isolated DNA preserved in a super-cold storage
facility. Because this collection preserves genetic material and gene
products from rare and endangered organisms that may become extinct
before science fully exploits their potential, it is an invaluable
resource for research in many fields including genetics, comparative
genomics, and biodefense. Capable of housing 1 million specimens, it
will be the largest super-cold tissue collection of its kind. In the
past 3 years, 22,000 specimens not available at any other institute or
facility have already been accessioned. At the same time, the Museum is
pioneering the development of collection and storage protocols for such
collections. To maximize use and utility of the facility for
researchers worldwide, the Museum is also developing a sophisticated
website and online database that includes collection information and
digitized images.
Cluster Computing
The Museum also has exceptional capacity in parallel computing, an
essential enabling technology for phylogenetic (evolutionary) analysis
and intensive, efficient sampling of a wide array of study organisms.
Museum scientists have constructed an in-house 700-processor computing
cluster--the fastest parallel computing cluster in an evolutionary
biology laboratory and one of the fastest installed in a non-defense
environment.
Museum investigators have taken a leadership role in developing and
applying new computational approaches to deciphering evolutionary
relationships through time and across species; their pioneering efforts
in cluster computing, algorithm development, and evolutionary theory
have been widely recognized and commended for their broad applicability
for biology as a whole. The bioinformatics tools Museum scientists are
creating will not only help to generate evolutionary scenarios, but
will also inform and make more efficient large genome sequencing
efforts. Many of the parallel algorithms and implementations
(especially cluster-based) will be applicable in other informatics
contexts such as annotation and assembly, breakpoint analysis, and non-
genomic areas of evolutionary biology as well as in other disciplines.
COMPARATIVE GENOMICS RESEARCH AND TRAINING INITIATIVE
Building on these unique strengths in comparative genomics, and in
concert with the health, education, and training goals of DHHS, in 2001
the Museum launched an ambitious initiative--The Institute of
Comparative Genomics. Equipped with the parallel computing facility,
molecular labs with DNA sequencers, ultra-cold storage units, vast
biological collections, and researchers with expertise in the methods
of comparative biology, as described above, the Institute is positioned
to be one of the world's premier facilities for mapping the genome
across a comprehensive spectrum of life forms.
The Institute is establishing a distinguished research and training
record. Museum scientists have pioneered theoretical and analytical
approaches and are leading major new international research projects in
assembling the ``tree of life.'' They have developed efficient software
for the interpretation of microarray data, which can be used to support
more accurate diagnosis of pathogens, and novel methodologies and
algorithms for analyzing genomic, chromosomal, and other data to
discern evolutionary relationships among organisms. Current projects
include sequencing pathogens and, with NIH and DOE support, tracing the
evolution of pathogenicity and transfer of disease-causing genes over
time and between species.
The Museum is also successfully promoting public understanding of
genomic science. The landmark exhibition, The Genomic Revolution, seen
by approximately 500,000 visitors in New York and now touring
nationally, examined the revolution taking place in molecular biology
and its impact on modern science and technology, natural history,
biodiversity, and our everyday lives. The Museum has also hosted
several conferences on important topics related to genomics: Sequencing
the Human Genome: New Frontiers in Science and Technology, an
international conference featuring leading scientists and policymakers
in Fall 2000; Conservation Genetics in the Age of Genomics in Spring
2001; and New Directions in Cluster Computing in June 2001, which
explored how parallel computing enables genomic science and other
fields. In June 2002, the Museum hosted an international conference
examining current knowledge of life's history, Assembling the Tree of
Life: Science, Relevance, and Challenges.
As it moves forward, the Institute, working in cooperation with New
York's outstanding biomedical research and educational institutions, is
focusing on molecular and microbial systematics, on constructing large
genomic databases, and on expanding our understanding of the evolution
of life on earth and the evolution of critical organismal form and
function through analysis of the genomes of selected microbes and other
non-human organisms. Development of Institute activities entails
expanding expertise in microbial systematics and the molecular
laboratory program that now trains dozens of graduate students every
year; utilizing the latest sequencing technologies; employing parallel
computing applications that allow scientists to solve combinatorially
complex problems involving large real world datasets; and continuing to
advance public understanding of genomic science through educational
materials, scientific conferences, and exhibits.
So as to contribute its unique capacities to the nation's genomics
research and training efforts, the Museum seeks to partner with DHHS/
HRSA in a facilities/instrumentation initiative. We request $1 million
to equip our National Research and Training Laboratory for Comparative
and Microbial Genomics, a state-of-the-art molecular laboratory. When
equipped, the expanded facility will provide up-to-date instrumentation
for graduate and postdoctoral trainees as well as for senior
scientists. The Museum will contribute its participatory share to this
project with funds from nonfederal as well as federal sources.
______
Prepared Statement of the American Academy of Physician Assistants
On behalf of the more than 51,000 clinically practicing physician
assistants in the United States, the American Academy of Physician
Assistants (AAPA) is pleased to submit comments on fiscal year 2005
appropriations for Physician Assistant (PA) education programs that are
authorized through Title VII of the Public Health Service Act.
A member of the Health Professions and Nursing Education Coalition
(HPNEC), the American Academy of Physician Assistants supports the
HPNEC recommendation to provide at least $550 million to support the
Titles VII and VIII programs in fiscal year 2005, including $18 million
to support PA educational programs, as recommended by the Advisory
Committee on Primary Care Medicine and Dentistry.
The Academy believes that the recommended increase in funding for
the Title VII health professions programs is well justified. The
programs are essential to the development and training of primary
health care professionals and contribute to the nation's overall
efforts to increase access to care by promoting health care delivery in
medically underserved communities.
The Academy is very concerned with the Administration's proposal to
eliminate funding for most Title VII programs, including zero funding
for training in primary care medicine and dentistry. As Members of the
Subcommittee are aware, these programs are designed to help meet the
health care delivery needs of the nation's Health Professional Shortage
Areas (HPSAs). By definition, the nation's more than 3,800 HPSAs
experience shortages in the primary care workforce that the market
alone can't address. We wish to thank the members of this subcommittee
for your historical role in supporting funding for the health
professions programs, and we hope that we can count on your support for
these important programs in fiscal year 2005.
OVERVIEW OF PHYSICIAN ASSISTANT (PA) EDUCATION
PA programs provide students with a primary care education that
prepares them to practice medicine with physician supervision.
Physician assistant programs are located at schools of medicine or
health sciences, universities, teaching hospitals, and the Armed
Services. All PA educational programs are intensive education programs
that are accredited by the Accreditation Review Commission on Education
for the Physician Assistant.
The typical PA program consists of 111 weeks of instruction. The
first phase of the program consists of intensive classroom and
laboratory study, providing students with an in-depth understanding of
the medical sciences. More than 400 hours in classroom and laboratory
instruction are devoted to the basic sciences, with over 70 hours in
pharmacology, more than 149 hours in behavioral sciences, and more than
535 hours of clinical medicine.
The second year of PA education consists of clinical rotations. On
average, students devote more than 2,000 hours or 50-55 weeks to
clinical education, divided between primary care medicine and various
specialties, including family medicine, internal medicine, pediatrics,
obstetrics and gynecology, surgery and surgical specialties, internal
medicine subspecialties, emergency medicine, and psychiatry. During
clinical rotations, PA students work directly under the supervision of
physician preceptors, participating in the full range of patient care
activities, including patient assessment and diagnosis, development of
treatment plans, patient education, and counseling.
Physician assistant education is competency based. After graduation
from an accredited PA program, the physician assistant must pass a
national certifying examination jointly developed by the National Board
of Medical Examiners and the independent National Commission on
Certification of Physician Assistants. To maintain certification, PAs
must log 100 continuing medical education credits over a 2-year cycle
and reregister every 2 years. Also to maintain certification, PAs must
take a recertification exam every 6 years.
PHYSICIAN ASSISTANT PRACTICE
Physician assistants are licensed health care professionals
educated to practice medicine as delegated by and with the supervision
of a physician. In all states, physicians may delegate to PAs those
medical duties that are within the physician's scope of practice and
the PA's training and experience, and are allowed by law. Forty-seven
states, the District of Columbia, and Guam authorize physicians to
delegate prescriptive privileges to the PAs they supervise.
PAs are located in almost all health care settings and in every
medical and surgical specialty. Nineteen percent of all PAs practice in
non-metropolitan areas where they may be the only full-time providers
of care (state laws stipulate the conditions for remote supervision by
a physician). Approximately 41 percent of PAs work in urban and inner
city areas. Approximately 44 percent of PAs are in primary care. Nearly
one-quarter practice in surgical specialties. Roughly 80 percent of PAs
practice in outpatient settings. In 2003, an estimated 192 million
patient visits were made to PAs and approximately 236 million
medications were prescribed or recommended by PAs.
CRITICAL ROLE OF THE TITLE VII, PUBLIC HEALTH SERVICE ACT, PROGRAMS
A growing number of Americans lack access to primary care, either
because they are uninsured, underinsured, or they live in a community
with an inadequate supply or distribution of providers. The growth in
the uninsured U.S. population increased from approximately 32 million
in the early 1990s to nearly 44 million today. Simultaneously, the
number of medically underserved communities continues to rise, from
1,949 in 1986 to more than 3,800 today.
The role of the Title VII programs is to alleviate these problems
by supporting access to quality, affordable, and cost-effective care in
areas of our country that are most in need of health care services,
specifically rural and urban underserved communities. This is
accomplished through the support of educational programs that train
more health professionals in fields experiencing shortages, improve the
geographic distribution of health professionals, and increase access to
care in underserved communities.
The Title VII programs are the only federal education programs that
are designed to address the supply and distribution imbalances in the
health professions. Since the establishment of Medicare, the costs of
physician residencies, nurses and some allied health professions
training has been paid through Graduate Medical Education (GME)
funding. However, GME has never been available to support PA education.
More importantly, GME was not intended to generate a supply of
providers who are willing to work in the nation's medically underserved
communities. That is the purpose of the Title VII Public Health Service
Act Programs, which support such initiatives as loans and scholarships
for disadvantaged students, scholarships for students with exceptional
financial need, centers of excellence to recruit and train minority and
disadvantaged students, and interdisciplinary initiatives in geriatric
care and rural health care.
Furthermore, now that there is compelling evidence that race and
ethnicity correlate with persistent, and often increasing, health
disparities among U.S. populations, increasing the diversity of health
care professionals is essential. Title VII programs are unique in that
they seek to recruit providers from a variety of backgrounds. This is
particularly important, as studies have found that those from
disadvantaged regions of the country are 3 to 5 times more likely to
return to those underserved areas to provide care versus other areas.
TITLE VII SUPPORT OF PA EDUCATION PROGRAMS
Targeted federal support for PA education programs is currently
authorized through section 747 of the Public Health Service Act. The
program was reauthorized in the 105th Congress through the Health
Professions Education Partnerships Act of 1998, Public Law 105-392,
which streamlined and consolidated the federal health professions
education programs. Support for PA education is now considered within
the broader context of training in primary care medicine and dentistry.
Publi Law 105-392 reauthorized awards and grants to schools of
medicine and osteopathic medicine, as well as colleges and
universities, to plan, develop, and operate accredited programs for the
education of physician assistants and faculty, with priority given to
training individuals from disadvantaged communities. The funds ensure
that PA students from all backgrounds have continued access to an
affordable education and encourage PAs, upon graduation, to practice in
underserved communities. These goals are accomplished by funding PA
education programs that have a demonstrated track record of: (1)
placing PA students in health professional shortage areas; (2) exposing
PA students to medically underserved communities during the clinical
rotation portion of their training; and (3) recruiting and retaining
students who are indigenous to communities with unmet health care
needs.
The program works. A review of PA graduates from 1990-2002 reveals
that students graduating from PA programs supported by Title VII are 84
percent more likely to be from underrepresented minority backgrounds
and 32 percent more likely to practice in underserved settings, than
students graduating from PA programs that were not supported by Title
VII.
The PA programs' success in recruiting and retaining
underrepresented minority and disadvantaged students is linked to their
ability to creatively use Title VII funds to enhance existing
educational programs. For example, a PA educational program in Iowa
uses Title VII funds to target recruitment efforts to disadvantaged
students, providing shadowing and mentoring opportunities for
prospective students, increasing training in cultural competency, and
identifying new family medicine preceptors in underserved areas. PA
programs in Texas use Title VII funds to create new clinical rotation
sites in rural and underserved areas, including new sites in border
communities, and to establish non-clinical rural rotations to help
students understand the challenges faced by rural communities. One
Texas program uses Title VII funds for the development of web based and
distant learning technology and methodologies so students can remain at
clinical practice sites. A PA program in New York, where over 90
percent of the students are ethnic minorities, uses Title VII funding
to focus on primary care training for underserved urban populations by
linking with community health centers, which expands the pool of
qualified minority role models that engage in clinical teaching,
mentoring, and preceptorship for PA students. Several other PA programs
have been able to use Title VII grants to leverage additional resources
to assist students with the added costs of housing and travel that
occur during relocation to rural areas for clinical training.
Without Title VII funding, many of these special PA training
initiatives would not be possible. Institutional budgets and student
tuition fees simply do not provide sufficient funding to meet the
special, unmet needs of medically underserved areas or disadvantaged
students. Nevertheless, the need is very real, and Title VII is
critical in meeting it.
NEED FOR INCREASED TITLE VII SUPPORT FOR PA EDUCATION PROGRAMS
Increased Title VII support for educating PAs to practice in
underserved communities is particularly important given the market
demand for physician assistants. Without the Title VII funding to
expose students to underserved sites during their training, PA students
are far more likely to practice in the communities where they were
raised or the communities in which they attended school. Title VII
funding is a critical link in addressing the natural geographic
maldistribution of health care providers by exposing students to
underserved sites during their training, where they frequently choose
to practice following graduation. Currently, 36 percent of PAs met
their first clinical employer through their clinical rotations.
Changes in the health care marketplace reflect a growing reliance
on PAs as part of the health care team. Currently, the supply of
physician assistants is inadequate to meet the needs of society, and
the demand for PAs is expected to increase. A 1994 report of a
workgroup of the Council on Graduate Medical Education (COGME),
``Physician Assistants in the Health Workforce,'' estimated that the
anticipated medical market demand and the estimated workforce
requirements for PAs would exceed supply. Additionally, the Bureau of
Labor Statistics projects that the number of available PA jobs will
increase 49 percent between 2002 and 2012. Title VII funding has
provided, and continues to provide, a crucial pipeline of trained PAs
to underserved areas. One way to assure an adequate supply of physician
assistants, especially PAs likely to practice in underserved areas, is
to continue offering financial incentives, such as funding preferences,
to PA programs that emphasize recruitment and placement of people
interested in primary health care in medically underserved communities.
Despite the increased demand for PAs, funding has not
proportionately increased for the Title VII programs that are designed
to educate and place physician assistants in underserved communities.
Nor has the Title VII support for PA education kept pace with increases
in the cost of educating PAs. A review of PA program budgets from 1984
through 2002 indicates an average annual increase of 6.5 percent, a
total increase of 218 percent over the past 18 years; yet, federal
support has remained relatively static.
RECOMMENDATIONS ON FISCAL YEAR 2005 FUNDING
A recent report by the Advisory Committee on Training in Primary
Care Medicine and Dentistry quotes a study in the Journal of Rural
Health: ``In 1997, Title VII funded programs increased the rates of
graduates entering health profession shortage areas (HPSAs), resulting
in 1,357 providers . . . Doubling the funding of these programs . . .
could decrease the time for HPSAs elimination to as little as 6
years.'' The Advisory Committee concluded that ``. . . Title VII
remains a modest investment, but, as has been demonstrated, one with
substantial future payoffs in terms of system quality, access to care,
and a culturally competent system of care for the entire population.''
The American Academy of Physician Assistants urges members of the
Appropriations Committee to consider the inter-dependency of all the
public health agencies and programs when determining funding for fiscal
year 2005. For instance, while it is important to fund clinical
research at the National Institutes of Health (NIH) and to have an
infrastructure at the Centers for Disease Control (CDC) that ensures a
prompt response to an infectious disease outbreak or bioterrorist
attack, the good work of both of these agencies will go unrealized if
the Health Resources and Services Administration (HRSA) is inadequately
funded. HRSA administers the ``people'' programs, such as Title VII,
that bring the cutting edge research discovered at NIH to the
patients--through providers such as PAs who have been educated in Title
VII-funded programs. Likewise, CDC is heavily dependent upon an
adequate supply of health care providers to be sure that disease
outbreaks are reported, tracked, and contained.
The critically important programs administered by NIH, HRSA, and
CDC are integral components within the nation's public health
continuum. One component is not more important than another, and no one
component can succeed without adequate support from each of the other
elements.
Furthermore, while the Academy applauds the Administration's
proposal to strengthen national security by increasing support for
health emergency preparedness initiatives, it should not do so at the
expense of Title VII programs. Training is the key to preparedness, and
Title VII, section 747, is an ideal mechanism for educating primary
care providers in public health competencies, facilitating population
based and community-based skills and training, and increasing the
alliance between public health and primary care providers. This is
particularly important for our Nation's most disadvantaged and
underserved populations, because they are the most vulnerable during
medical emergencies because of a lack of resources and access to care.
The Academy respectfully requests that the Title VII and VIII
health professions programs receive $550 million in funding for fiscal
year 2005, including $18 million to support PA educational programs, as
recommended by the Advisory Committee on Primary Care Medicine and
Dentistry.
Thank you for the opportunity to present the American Academy of
Physician Assistants' views on fiscal year 2005 appropriations.
______
Prepared Statement of the National Alliance for the Mentally Ill
Chairman Specter, Senator Harkin and members of the Subcommittee, I
am Margaret Stout of Johnson, Iowa. I current serve as President of the
National Alliance for the Mentally Ill (NAMI) and Executive Director of
NAMI's statewide Iowa affiliate. I am pleased to offer NAMI's view on
the Subcommittee's fiscal year 2005 bill.
NAMI is the nation's largest grassroots advocacy organization,
220,000 members representing persons with serious brain disorders and
their families. Through our 1,200 chapters and affiliates in all 50
states, we support education, outreach, advocacy and research on behalf
of persons with serious brain disorders such as schizophrenia, manic
depressive illness, major depression, severe anxiety disorders and
major mental illnesses affecting children.
Mr. Chairman, for too long severe mental illness has been shrouded
in stigma and discrimination. These illnesses have been misunderstood,
feared, hidden, and often ignored by science. Only in the last decade
have we seen the first real hope for people with these brain disorders
through pioneering research that has uncovered both a biological basis
for these brain disorders and treatments that work.
The cost of mental illness to our nation is enormous. President
Bush's White House Mental Health Commission--which completed its work
in 2003--found that the direct treatment cost exceeds $71 billion
annually. This does not include the $79 billion in estimated indirect
costs of benefits and social services (including 35 percent of SSI
benefits and 28 percent of SSDI benefits). These direct and indirect
costs do not measure the substantial and growing burden that is imposed
on ``default'' systems that are too often responsible for serving
children and adults with mental illness who lack access to treatment.
These costs fall most heavily on the criminal justice and corrections
systems, emergency rooms, schools, families and homeless shelters.
Moreover, these costs are not only financial, but also human in terms
of lost productivity, lives lost to suicide and broken families.
Investment in mental illness research and services are--in NAMI's
view--the highest priority for our nation and this Subcommittee.
FUNDING FOR SERVICES PROGRAMS AT SAMHSA & CMHS
The Center for Mental Health Services (CMHS)--part of the Substance
Abuse and Mental Health Services Administration (SAMHSA)--is the
principal federal agency engaged in support for state and local public
mental health systems. Through its programs CMHS provides flexible
funding for the states and conducts service demonstrations to help
states move toward adoption of evidence-based practices. Funding for
all SAMHSA and CMHS programs is part of the Fiscal Year 2005 Labor-HHS-
Education Appropriations bill that Congress will soon consider.
CMHS Programs and the Crisis Confronting the Public Mental Health
System
During the recent economic downturn and resulting crisis the state
budgets are facing, we are witnessing widening of gaps in the public
mental illness treatment system in many states. This is resulting in
unprecedented cuts being enacted by states in both direct spending on
mental illness treatment and supportive services, and in Medicaid
funding of such services. Deep cuts to front-line clinics and providers
in the public mental health system, curbs on access to newer more
effective medications and closure of acute care beds in the community
are just a few of the misguided strategies that states are employing to
close their widening budget gaps. The consequences of these emerging
cracks in the service system are readily apparent, not just to NAMI's
consumer and family membership, but also to the public: increased risk
of suicide, the growing number of chronic homeless adults and the
growing trend of ``criminalization'' of mental illness and the stress
it is placing on state and local jails and prisons.
The Need to Focus on Recovery-Oriented Evidence-Based Practices
As states continue to cut funding for mental illness treatment and
supportive services, CMHS programs are becoming an increasingly
important source of funding for the states. First and foremost, states
should be encouraged to use their CMHS Block Grant funds to prevent
further cuts in services for children and adults with severe mental
illnesses. NAMI also supports targeting of CMHS dollars toward
investment in evidence-based, outreach-oriented service delivery models
for persons with severe mental illness in the community. The need to
focus limited resources on evidence-based models (such as Programs of
Assertive Community Treatment (PACT) and integrated treatment for co-
occurring disorders) was recommended in 2003 by the President's ``New
Freedom Initiative'' Mental Health Commission Report. This landmark
report called for a reform of the public mental health system to
eliminate system fragmentation and better reflect the priorities of
recovery and community integration.
NAMI Supports the Bush Administration's Request for a ``Mental Health
System Transformation'' Initiative
The President's fiscal year 2005 budget includes a request for $44
million at CMHS for a new state incentive grant program for ``Mental
Health System Transformation.'' This initiative is intended to help
states follow through on the July 2003 recommendations in the White
House ``New Freedom Initiative'' Mental Health Commission report. Under
the proposal, funds would be allocated to states on a competitive basis
to support the development of comprehensive state mental health plans
to reduce system fragmentation and increase access to evidence-based
services that promote recovery from mental illnesses. States would be
required to use funds to develop plans that cut across multiple systems
such as housing, criminal justice, child welfare, employment and
education. In subsequent years, up to 85 percent of funds could be used
to support community-based programs, with the remaining 15 percent
available for state planning and coordination. NAMI strongly supports
this proposal as critical to the effort to reform our nation's
fragmented and underfunded public mental health system and bridge the
gap between scientific advances and practice.
NAMI Supports the ``Samaritan'' and ``ELHSI'' Initiatives to End
Chronic Homelessness
The President's fiscal year 2005 budget proposes $70 million to
continue the ``Samaritan Initiative'' to end chronic homelessness over
the next decade, with funding spread across SAMHSA, HUD and the VA. In
addition, the Bush Administration is seeking a $5 million increase for
the Projects for Assistance in Transition from Homelessness (PATH)
program--boosting fiscal year 2005 funding to $55 million. PATH is a
formula grant program to the states that funds outreach and engagement
services for homeless individuals with severe mental illnesses. CMHS
estimates that this increase in the PATH program will result in 154,000
homeless individuals with severe mental illnesses being served by state
and local PATH grantees. NAMI also urges additional funding in fiscal
year 2005 for the PATH program to address inequities in the program's
interstate funding formula that have the allocation for many smaller
rural states frozen since the mid-1990s.
NAMI urges full funding of the ``Samaritan Initiative'' in fiscal
year 2005 and the proposed increase for PATH. Individuals with severe
mental illnesses and co-occurring substance abuse disorders make up the
largest share of the more than 150,000 people who experience chronic
homelessness--those who stay homeless for a year or more. In addition
to supporting the Administration's Samaritan Initiative and the
recommended increases for PATH, NAMI also supports funding for the
Ending Long-Term Homeless Services Initiative (ELHSI) program at SAMHSA
to assist states and localities in funding services for new permanent
supportive housing being developed through HUD's McKinney-Vento
program. Funding at SAMHSA for Samaritan and ELHSI is critical to
producing and sustaining 150,000 units of permanent supportive housing
that will all but eliminate chronic homelessness. Ending chronic
homelessness through permanent supportive housing will pay for itself,
as communities save hundreds of millions of dollars in that communities
are relieved of the costs related to keeping people homeless--including
those associated with shelters, emergency rooms and jails.
Funding for CMHS Programs in the President's fiscal year 2005 Budget
In addition to the initiatives noted above, NAMI also supports
ongoing activities at CMHS:
--Mental Health Block Grant.--CMHS's largest program, the Mental
Health Block Grant (state formula grant program), would receive
a $2 million increase under the President's fiscal year 2005
budget proposal (boosting funding to $436 million).
--Children's Mental Health program at CMHS.--The President is
requesting a $4 million increase for the Children's Mental
Health program, increasing funding to $106 million.
--Programs of Regional and National Significance.--CMHS's own
discretionary budget--known as Programs of Regional and
National Significance (PRNS)--would increase under the
President's budget to $271 million. This includes the $44
million mental health system transformation initiative noted
above.
--Co-Occurring Disorders.--The request for fiscal year 2005 for the
PRNS program includes $15.2 million in ongoing and new funding
for best practices and targeted capacity expansion grants to
foster increased access to integrated treatment for individuals
with co-occurring mental illness and substance abuse disorders.
SAMHSA has an important leadership role to play on this issue.
NAMI strongly urges this Subcommittee to support expansion of
SAMHSA's activities on this critical priority.
--Jail Diversion.--NAMI is disappointed that the President's budget
does not request continued funding for the $7 million Jail
Diversion program at CMHS. NAMI strongly supports the Jail
Diversion program and urges continuation of funding in fiscal
year 2005.
--Suicide Prevention.--NAMI strongly supports continuation and
expansion of CMHS's best practices grants and contracts to
support suicide prevention. The President's ``New Freedom
Initiative'' Mental Health Commission report contains important
recommendations on making suicide prevention a national
priority. NAMI supports these recommendations as critical to
addressing the estimated 30,000 suicides that occur every year
in our country--90 percent of which involve a victim with a
mental disorder.
national institute of mental health (nimh) research funding
The National Institute of Mental Health (NIMH) is the only federal
agency with the main objective of funding biomedical research into
serious mental illnesses. Increased funding and focus is needed to
achieve the promise of exciting gains in understanding the brain in
upcoming years.
NIMH--Smallest Proposed Increase in 8 Years
For fiscal year 2005, the President is proposing a $1.421 billion
budget for the NIMH. This is a $39 million increase--2.2 percent--over
the amount Congress appropriated for NIMH for fiscal year 2004 ($1.39
billion). While this exceeds the average 0.5 percent increase for all
domestic discretionary spending, it is below the 2.7 percent increase
proposed for all of the National Institutes of Health (NIH)--which
would increase to $28.805 billion under the President's budget. In
addition, this proposed increase for NIMH for fiscal year 2005 is below
the 3.6 percent increase that Congress enacted for fiscal year 2004 and
far below the 8 percent and 9 percent annual increases that were
achieved between fiscal year 1998 and 2003.
This minimal budget increase is expected to have a serious impact
on the ability of NIMH to sustain ongoing multi-year research grants
that have been initiated over the past 3-4 years and fund new grant
proposals relevant to serious mental illness. This is especially the
case if Congress accepts a proposal being floated by NIH to limit
annual ``cost of doing research'' adjustments to individual grants to 1
percent per year. NAMI remains very concerned that this coming fall-off
in budget increases for NIH does not wipe out the new research that has
been undertaken at NIMH in recent years, and take advantage of the
significant opportunities to advance treatments and cures for serious
mental disorders.
Mr. Chairman, NAMI is deeply grateful for your leadership on this
Subcommittee in seeking a strong budget for NIH and NIMH. The
bipartisan commitment to scientific research that you and Senator
Harkin continue to demonstrate is an example to your colleagues in
Congress and in the Administration. We commend you for your amendment
on the Senate floor during debate on the fiscal year 2005 budget
resolution to increase NIH funding above the President's request. NAMI
urges you and your colleagues to make every effort to fund in NIMH at
the ``professional judgment'' recommendation for fiscal year 2005--
$1.555 billion, or $172.8 million above the fiscal year 2004 level.
``Roadmap to Recovery and Cure''--NAMI's Advocacy Goals and Strategies
on Mental Illness Research
This month, the NAMI Policy Research Institute is releasing a new
report, Roadmap to Recovery and Cure, urging significant increases in
the NIMH budget for basic, clinical and health services research
focused on serious mental illness. The reality is that dramatic
improvements in the lives of individuals with mental illness can be
achieved over the next decade if research is expanded and the treatment
system reformed and brought into closer alignment with research.
Among the conclusions in Roadmap to Recovery and Cure are that
serious mental illness research has been underfunded, compared to other
chronic, disabling illnesses, and is insufficiently prioritized at
NIMH. The task force also found that psychiatric research has only
begun to enter the modern era of biomedical research and requires the
development of a strong base of basic and interdisciplinary research,
large, policy-relevant clinical trials and services research directly
tied to service delivery. It is important to note that all of these are
integral to the Bush Administration's Roadmap to Medical Research
initiative that is currently driving research priorities at NIH.
Among the recommendations in this report are:
--Significant and accountable increases in NIMH funding of basic,
clinical and services research focused on serious mental
illness--$1 billion over 5 years,
--Increased application of the NIH's Roadmap to Medical Research
initiative to serious mental illness,
--Continuation and expansion of clinical trials focused on serious
mental illness,
--Coordination of serious mental illness research, dissemination, and
service system policy efforts by the federal government, and
--Increased training and support of researchers and mental health
care providers.
The Case for Increased Federal Investment in Mental Illness Research
Further research is imperative if we are to prevent the next
generation from suffering. Much has to be learned. The causes and
mechanisms of diseases such as schizophrenia and bipolar disorder are
mostly unknown. We do not yet have laboratory tests that can diagnose
these illnesses. There are no side-effect free treatments. And, of
course, there is no primary preventive measure or cure currently
available.
Treatment is imperfect; it does not work well for all individuals
living with these brain diseases. There are no cures for severe mental
illnesses, and existing treatments and services shown to be effective
are all too often not available to the people who need and deserve
them. While steady research-funding gains have been achieved, NAMI
believes that severe mental illness research, from the most basic to
services research, remains underfunded, given the tremendous scientific
opportunities that exist and the severe burden that these diseases
present to the public as well as to our families.
The public health burden associated with severe mental illness is
enormous, accounting for a large percentage of costs imposed by all
illnesses in the United States. An independent study by the World Bank
and World Health Organization (DALY: Disability Adjusted Life Years)
found that four of the top ten causes of disability worldwide are
severe mental illnesses: major depression, bipolar disorder,
schizophrenia, and obsessive-compulsive disorder, accounting for 25
percent of the total disability resulting from all diseases and
injuries.
Where Should Funding at NIMH Be Directed?
Greater Focus & Accountability on Severe Mental Illness.--NAMI
believes that more focus is needed at NIMH on severe mental illness
research. NAMI therefore urges Congress to require NIMH to provide an
accounting of new and existing research grants broken down by specific
illnesses.
Basic Neuroscience.--NIMH needs to continue progress that has been
made in unraveling the mysteries of molecules, genes, and brain
interconnections related to higher brain functioning in brain health
and serious disease.
Treatment Research.--Currently there is a lack of understanding
about which treatments work best for which patients, in what
combination, and with what risks and costs. NIMH has invested in
significant research to improve this understanding and it should be
continued and expanded in the current budget. Importantly, new
treatments must be developed as well.
Services Implementation.--There are many important, even crucial
research questions relevant to the treatment system that serves
individuals with severe mental illnesses--ranging from improving the
provision of evidence-based care to identifying exactly how much public
monies are being spent on a treatment system that more often than not
is failing.
Consumer and Family Involvement in Research.--All of these efforts
at NIMH must be done with a greater involvement with and accountability
to those patients with severe illnesses and their families. Recent
efforts at NIMH have moved in this direction, but more needs to be done
to integrate families and patients into annual reporting and strategic
planning on research investments and accomplishments.
CONCLUSION
Chairman Specter, Senator Harkin and members of the Subcommittee,
thank you for the opportunity to offer NAMI's views on your fiscal year
2005 bill.
______
Prepared Statement of the Association of Maternal and Child Health
Programs
Mr. Chairman and members of the subcommittee, the Association of
Maternal and Child Health Programs (AMCHP) is pleased to submit
testimony on the Maternal and Child Health Services Block Grant as you
consider the fiscal year 2005 funding request for the Department of
Health and Human Services. AMCHP is a national non-profit organization
representing the leaders of state public health programs for maternal
and child health, and children with special health care needs in all 50
states, the District of Columbia, and eight additional jurisdictions.
AMCHP appreciates the subcommittee's continued support of the MCHBG,
the common source of funding for our members.
I urge you to provide $807 million for the Maternal and Child
Health Services Block Grant (MCHBG) in fiscal year 2005. This funding
level is necessary to maintain at least fiscal year 2003 levels of
service in every state. Additionally, continued funding ($5 million)
within the Special Projects of Regional and National Significance
(SPRANS) set-aside for MCH oral health grant activities is critical. As
I will explain below, these funds are needed to help state MCH programs
that have been hit hard by state budget cuts, rising demand for
services, and years of federal flat funding.
Maternal and child health programs help to increase immunization
and newborn screening rates, reduce infant mortality, prevent childhood
accidents and injuries, and reduce adolescent pregnancy. Each year,
more than 27 million women, infants, children and adolescents,
including those with special health care needs, are served by MCH Block
Grant funds. Half of the 4 million women who give birth annually
receive some prenatal or postnatal services made possible by the MCHBG.
State maternal and child health programs need strong financial
support to meet the challenges ahead. Unfortunately, this year 31
states (Alabama, Arkansas, Colorado, Illinois, Indiana, Iowa, Kansas,
Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota,
Mississippi, Missouri, Montana, Nebraska, New Mexico, North Dakota,
Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee,
Texas, Utah, Vermont, West Virginia, Wisconsin, Wyoming) receive less
in MCH block grant funding than in fiscal year 2003. These cuts range
from a few thousand dollars to over $1.6 million. Please see the chart
at the end of this testimony.
The President's fiscal year 2005 budget flat funds the MCH Block
Grant at $730 million again. The President also proposes to add the
Universal Newborn Hearing Screening/Trauma Programs to the MCHBG
without the $13 million that the programs received in fiscal year 2003.
This would force states to cut other worthy MCH programs in order to
continue important hearing screening activities or to scale back their
hearing screening activities. According to a recent report, thanks to
the HRSA funding, the number of infants screened for hearing loss at
birth rose almost 20 percent in 2003. Today, 86 percent of infants born
in hospitals nationwide are screened for hearing loss, up from 25
percent in 1999.
The need for increased funding is clear and I urge you to provide
$807 million for the Maternal and Child Health Services Block Grant in
fiscal year 2005. This increase assures that every state receive at
least the amount that they received from the MCH Block Grant in fiscal
year 2003. Without this funding, states' ability to serve the millions
of American women, children, and their families who rely on these
programs (approximately 27 million in 2002) would be jeopardized. In
every state, Title V is a safety net program for low-income women and
children, often the payor of last resort for needed medical services
when other sources of payment (either public or private) are not
available.
State programs funded through the MCH Block Grant make a
difference. Without sufficient funding, over 18 million children will
be without the vital health care they need, over 2 million pregnant
women will not receive prenatal and postnatal care and have a healthy
pregnancy, and almost 1 million children with special health care need
will have to battle a fragmented health care system on their own to get
the services they require.
Below are specific examples of how reductions at the state and
federal levels have affected state maternal and child health programs.
Please keep in mind that the actual effect of the cuts will not be
fully felt until fiscal year 2005. That's why it is important that you
provide sufficient funding in the fiscal year 2005 for the Maternal and
Child Health Services Block Grant.
OHIO
Ohio received one of the steepest cuts in aid, losing $1.5 million
(or 6 percent) between fiscal year 2003 and fiscal year 2004 in federal
MCH funding. Combined with a $7.5 million decline in the state funds
available to support MCH, the ability for the program to maintain
services to the 266,000 women, infants, and children who received
services in 2002 has been severely compromised. Ohio's Children with
Special Health Care Needs (CSHCN) program, because of both state cuts
and cuts in the Ohio MCH Block Grant, has had to decrease the number of
diagnoses covered by the CSHCN Treatment Program and to change the
eligibility rules to reduce the services provided. Three diagnosed
conditions (Tonsils/adenoids, Serous otitis media, Hernias--except
diaphragmatic) were eliminated from the list of those eligible to
receive services, affecting almost 600 children.
Other changes may reduce, by as much as 25 percent, the 5,000
children who rely on the program. Co-payments are increased for
families. Children with special health care needs require more frequent
office visits. Raising co-payments can significantly impact the
financial and physical health of these families and their children if
they are unable to pay them. These families turn to Title V when
insurance (either private or public) cannot provide the services. The
Ohio Specialty Field Clinic Program received a 20 percent decrease in
MCH block grant and other funding support. The Specialty Clinic Program
provides access to pediatric specialists for children in Ohio. The
number of clinics will be cut, all in rural Ohio where the greatest
need for services are. This will affect the access to care for 300
children in Ohio's rural areas. Cardiac Specialty Clinics will be
closed as of July 1, 2004. Funding reductions also slow the ability to
respond to emerging issues, such as an increase in Ohio's infant
mortality rate.
ALABAMA
Alabama lost $450,000 in federal funding. Combined with state cuts,
the MCH program has had to significantly cut back services and staff.
Funding for the Monsky Developmental Clinic was slashed by 50 percent.
The Monsky Developmental Clinic provides developmental assessments of
children with suspected or documented developmental delay (primarily
for children from low income families). The clinic maintains a highly
specialized multi-disciplined staff of professionals. Monsky is one of
two clinics in Alabama that provides this service for children with
special health care needs and serves the South Alabama region. The MCH
program is the largest financial supporter of the clinic. MCH also lost
a public health nurse position that had been working to engage the
growing Hispanic community. Without funding to fill the position, it
will be difficult to pro-actively address perinatal issues in the
growing Hispanic/Latino population in Alabama. There were 2,630 live
births to Hispanic/Latino Alabama residents in CY 2002: a 14.7 percent
increase over the number in CY 2001.
IOWA
Iowa lost approximately $355,000 in fiscal year 2004. These cuts
forced the Iowa Children with Special Health Care Needs program (Iowa
Health Specialty Clinics program at the University of Iowa) to cut
nutrition services to all children with special needs across Iowa,
close the regional specialty clinic in Waterloo, cut the Dubuque clinic
by 80 percent, and cut two other clinics by 20 percent. Scores of
parents, teachers and educators who teach children who receive services
through these clinics have written letters to the CSHCN program
protesting the closures and/or reductions at these sites citing the
devastating effect on those in need of the services.
TEXAS
Texas received a reduction of $753,000 (3 percent) in federal MCH
funds. That reduction along with a reduction in state funds for MCH in
2004-2005 will drastically increase the unmet needs of the MCH
population in Texas. Currently, the MCH program addresses less than 10
percent of the MCH population-in-need. For example, Title V MCH fiscal
year 2004 contracts funding for population-based services (i.e.,
initiatives directed toward teen pregnancy, childhood obesity,
immunization, etc) was decreased by 33 percent and by 13 percent for
direct services (prenatal care, child well-check visits, dental, family
planning, etc.). In 2001, the Texas Children with Special Health Care
Needs program instituted a waiting list that has grown to 1,200
families and is expected to continue to increase.
WISCONSIN
Wisconsin loses $776,600 (or 6 percent). Options being considered
to address this shortfall include applying an across-the-board cut to
local projects as well as at the state and regional offices. A
reduction to local projects translates to less activities and services
received by the maternal and child health population. This will
translate to children and families not receiving necessary services. In
light of these cuts and the many more that I am unable to include in
this testimony, I strongly urge you to provide states increased
resources through the MCH block grant in fiscal year 2005 to protect
services to low income pregnant women, infants, children with special
health care needs and their families. $807 million in fiscal year 2005
does just that.
Again, thank you for this opportunity to testify.
----------------------------------------------------------------------------------------------------------------
Fiscal year
--------------------------------
State 2004 Difference
2003 actual conference
----------------------------------------------------------------------------------------------------------------
Alabama......................................................... $12,866,149 $12,415,309 -$450,840
Alaska.......................................................... 1,146,370 1,180,409 34,039
Arizona......................................................... 7,406,094 7,842,357 436,263
Arkansas........................................................ 7,785,008 7,524,664 -260,344
California...................................................... 44,341,423 48,441,501 4,100,078
Colorado........................................................ 7,794,869 7,603,353 -191,516
Connecticut..................................................... 4,946,958 4,998,766 51,808
Delaware........................................................ 1,982,247 2,034,791 52,544
District of Columbia............................................ 7,050,811 7,170,736 119,925
Florida......................................................... 20,017,388 20,994,684 977,296
Georgia......................................................... 17,316,887 17,348,033 31,146
Hawaii.......................................................... 2,281,433 2,392,416 110,983
Idaho........................................................... 3,373,874 3,387,761 13,887
Illinois........................................................ 23,969,437 23,027,020 -942,417
Indiana......................................................... 12,665,552 12,318,758 -346,794
Iowa............................................................ 7,115,676 6,760,133 -355,543
Kansas.......................................................... 5,151,370 4,963,545 -187,825
Kentucky........................................................ 12,553,023 11,948,246 -604,777
Louisiana....................................................... 15,533,194 14,293,453 -1,239,741
Maine........................................................... 3,546,787 3,518,418 -28,369
Maryland........................................................ 12,212,800 12,367,885 155,085
Massachusetts................................................... 12,046,095 11,968,951 -77,144
Michigan........................................................ 21,596,187 19,903,294 -1,692,893
Minnesota....................................................... 9,845,406 9,427,666 -417,740
Mississippi..................................................... 11,169,460 10,337,878 -831,582
Missouri........................................................ 13,318,533 13,030,039 -288,494
Montana......................................................... 2,609,133 2,560,004 -49,129
Nebraska........................................................ 4,270,142 4,183,264 -86,878
Nevada.......................................................... 1,581,541 1,996,035 414,494
New Hampshire................................................... 2,023,344 2,071,712 48,368
New Jersey...................................................... 12,102,033 12,348,050 246,017
New Mexico...................................................... 4,798,959 4,723,796 -75,163
New York........................................................ 42,726,728 43,708,310 981,582
North Carolina.................................................. 17,183,075 17,522,028 338,953
North Dakota.................................................... 2,007,580 1,882,687 -124,893
Ohio............................................................ 24,889,019 23,310,577 -1,578,442
Oklahoma........................................................ 8,041,242 7,791,761 -249,481
Oregon.......................................................... 6,484,811 6,579,878 95,067
Pennsylvania.................................................... 26,051,877 25,621,198 -430,679
Rhode Island.................................................... 1,768,713 1,890,246 121,533
South Carolina.................................................. 12,151,811 11,952,796 -199,015
South Dakota.................................................... 2,469,092 2,357,003 -112,089
Tennessee....................................................... 12,693,368 12,419,315 -274,053
Texas........................................................... 38,661,981 37,908,796 -753,185
Utah............................................................ 6,336,960 6,222,721 -114,239
Vermont......................................................... 1,746,907 1,742,951 3,956
Virginia........................................................ 12,947,026 13,001,114 54,088
Washington...................................................... 9,364,663 9,613,745 249,082
West Virginia................................................... 7,058,712 6,712,857 -345,855
Wisconsin....................................................... 11,916,084 11,261,938 -654,146
Wyoming......................................................... 1,333,642 1,309,374 -24,268
-----------------------------------------------
Subtotal.................................................. 572,251,474 567,892,222 -4,359,252
----------------------------------------------------------------------------------------------------------------
______
Prepared Statement of the National Treasury Employees Union
Chairman Specter, Members of the Subcommittee: My name is Colleen
M. Kelley and I am the National President of the National Treasury
Employees Union (NTEU). NTEU represents more than 150,000 federal
employees across 29 agencies and departments of the federal government,
including employees in a number of divisions of the Department of
Health and Human Services.
NTEU represents employees in the following divisions of the
Department of Health and Human Services: the Health Resources and
Services Administration (HRSA), Substance Abuse and Mental Health
Services Administration (SAMHSA), Administration for Children and
Families (ACF), Administration on Aging (AoA), Office of the Secretary
(OS), Office for Civil Rights (OCR), Program Support Center (PSC) and
the National Center for Health Statistics (NCHS). NTEU also represents
employees in the Social Security Administration's Office of Hearings
and Appeals (OHA).
As the Chairman knows, for several years now, most federal agencies
have struggled to accomplish their missions to the best of their
abilities within tight fiscal constraints. Many federal agencies have
not had the necessary funds to adequately train their employees, others
have been forced to downsize to the point where they are not staffed
appropriately for their missions and still other agencies have not had
the resources to use the tools at their disposal to attract and retain
the workforces they know they need for the future. These tools include
recruitment and retention bonuses as well as the ability to help
employees with student loan expenses--tools that the private sector
knows are imperative to attracting and retaining the best employees.
The federal government faces an unprecedented recruitment and
retention crisis. In addition to adequately funding agencies to perform
their missions, NTEU believes that a major step toward making the
federal government an employer of choice is a commitment by Congress
and the Administration to establish a fair process for setting federal
salaries. As you know, Mr. Chairman, for 2 years in a row now, despite
a bipartisan and bicameral commitment to pay parity between the
Nation's military and civilian employees, the President has chosen to
implement a smaller pay raise for civilian employees only to see that
raise overturned by subsequent Congressional action.
The message this sends federal employees is that they are not as
important as their military counterparts, that they are somehow not as
deserving of a fair pay raise. Here it is March 2004 and the pay raise
these employees should have received the first pay period in January
has still not reached their paychecks. While the full 4.1 percent pay
raise is retroactive to January, agencies are still struggling to
update their payroll systems and implement the full amount of the pay
raise. We are told it may be several more months before all federal
employees receive the full pay raise Congress approved.
Adequate and stable agency funding coupled with appropriate federal
pay and benefits are the keys to ensuring that the government is able
to attract and retain the federal employees it requires. The need for
the federal government to hire and maintain a highly skilled workforce
has never been more clear. Federal employees protect our Nation's
medical supplies, they help secure our borders and they provide
important services and information to their fellow taxpaying citizens
every day.
The Administration's fiscal year 2005 budget request continues to
hold federal agencies to unrealistic funding levels. We cannot continue
to ask our agencies to do more while ignoring their requests for
appropriate funding.
The Administration's fiscal year 2005 request for program
management funding at the Health Resources and Services Administration
(HRSA) is $158 million. Although this figure represents a $3 million
increase in administrative funds over the fiscal year 2004 funding
level, it is important to remember that HRSA's 2004 funding level
represented a reduction of $9 million from the prior year. For an
agency charged with insuring access to quality health care, especially
to underserved populations--services that are in desperate need of
expansion--a considerably larger increase in program management funding
is called for. HRSA cannot effectively accomplish its mission without
additional resources.
The President's budget proposes a substantial increase in funding
for the National Center for Health Statistics (NCHS) for fiscal year
2005, a budget increase that is long overdue. As you know, the work
NCHS undertakes is critical to ensuring that national health care
initiatives are effective and the agency has been held to unrealistic
funding levels for too many years now. NTEU hopes the fiscal year 2005
budget request will be enacted for NCHS.
The budget request for program management funds in 2005 at the
Substance Abuse and Mental Health Services Administration (SAMHSA) is
$92 million, the same as the agency's funding level for fiscal year
2004. SAMHSA is the federal agency charged with improving the quality
and availability of treatment and intervention programs for those
suffering from substance abuse and mental illness. It is discouraging
to see this important agency held to an unrealistic funding level for
the coming fiscal year and I am hopeful that program management funding
for SAMHSA in fiscal year 2005 can be increased.
The President's budget proposal for fiscal year 2005 for the
Administration for Children and Families (ACF), represents an increase
of $12 million for federal administration of the programs ACF oversees.
Funding restrictions in past years have hampered this agency's ability
to accomplish its missions and NTEU strongly supports increased funding
for the federal administration of ACF programs.
However, at the same time, we must continue to state our strong
opposition to legislation pending in Congress to reauthorize the Head
Start Program. As you know, the Head Start Program allows many children
from low-income families to access a package of educational and social
services that supplement the student's learning. Under the direction of
the federal government, the Head Start Program has enhanced the
opportunities of millions of American children since its inception.
Legislation that seeks to limit the involvement of the federal
government with the Head Start Program, such as H.R. 2210, is
shortsighted and threatens to move the program in the wrong direction.
Similarly, S. 1940, which encourages contracting out the oversight of
the Head Start Program to profit-driven firms in the private sector,
must be reconsidered. I hope that the Committee will carefully review
the Head Start reauthorization legislation before it is voted on by the
full House and Senate.
The President's budget recommends only a slight improvement in
funding for program administration for the Administration on Aging
(AoA), holding the agency's program administration funding level to $18
million for 2005. With our country's rapidly growing older population,
this is particularly troublesome. The Administration on Aging helps
older Americans remain independent and productive and offers nutrition,
caregiver support and preventive health programs. These are precisely
the type of programs desperately in need of expansion, yet the fiscal
year 2005 budget proposal, like the 2004 budget before it offers little
in the way of new funding for these critical areas. The AoA funding
level, too, requires the careful scrutiny of this Subcommittee.
The Office of the Secretary (OS) of the Department of Health and
Human Services is slated to receive increased funding in fiscal year
2005. Federal employees working in the Office of the Secretary help
administer all of the programs operated by the Department of Health and
Human Services. It is critical that this office be effectively funded
and NTEU is pleased to see a significant funding increase for this
division. We urge the Committee to approve this request.
The President's budget recommends a small increase in program
funding for the Office for Civil Rights (OCR). The recommendation would
increase this agency's resources from their 2004 funding level of $34
million to $35 million in 2005. The HHS Office for Civil Rights helps
to ensure that all individuals have proper access to the services and
programs the Department offers. Moreover, this agency helps promote the
privacy of medical information. In past years, OCR has been woefully
under funded and NTEU urges this body to carefully review their funding
needs for 2005.
The Department of Health and Human Services' Program Support Center
(PSC) offers a range of administrative services both to HHS agencies
and other federal departments that seek out its services. The
President's fiscal year 2005 budget, which requests an increase in
expenses for this key agency over their fiscal year 2004 funding level,
deserves to be adopted by this body.
NTEU also represents employees in the Office of Hearing and Appeals
(OHA) of the Social Security Administration. As the Chairman knows very
well, OHA's mission is to assist those claimants who have been found
ineligible for Social Security disability benefits by providing a due
process hearing on their cases. The continuing backlog of cases before
OHA prevents a fair and timely hearing for the thousands of individuals
whose disability cases must be heard there. One of the problems facing
OHA is that it lacks sufficient decision makers to handle its
continuing and rapidly growing workload.
For almost a decade, SSA's disability program has been in crisis.
In 1995, SSA introduced a program called the Senior Attorney Program
that was instrumental in reducing the backlog and improving processing
times. The agency's experienced staff attorneys were given the
authority to decide and issue fully favorable decisions--without the
time and expense of a full hearing--in those cases where the evidence
clearly identified an individual as disabled. In every respect, the
Senior Attorney Program was a success. Unfortunately, SSA chose to
terminate this innovative program as it undertook its Hearings Process
Improvement (HPI) plan, a plan SSA now admits was unsuccessful.
On a more positive note, current Social Security Commissioner
Barnhart has undertaken an objective review of the entire disability
system. Finally, senior SSA officials truly understand the strengths
and deficiencies of the current system. This insight combined with the
Commissioner's commitment to create a process which serves the needs of
the public rather than the dictates of the bureaucracy, have led her to
propose a plan for implementing fundamental process changes that will
provide a level of service of which we all can be proud.
The plan is comprehensive and involves extensive changes such as
the eventual replacement of paper folders with electronic folders,
elimination of the Reconsideration Determination, elimination of the
Appeals Council, a completely revamped quality assurance system, and
the creation of the Reviewing Official position to provide an
intermediate step between the State Agency and the ALJ. NTEU is
convinced that this plan, if implemented, will result in an efficient,
effective, and most importantly, a fair adjudicatory process.
In a particularly important initiative proposed by the
Commissioner, a Reviewing Official, or RO position, will be created.
This individual will be an attorney and will apply the same
adjudicatory standards to the disability determination process, as will
the Administrative Law Judges. Past experience from the Senior Attorney
Program indicates that the creation of this position in conjunction
with the other improvements the Commissioner seeks to put in place will
result in many disabled claimants being awarded benefits in as little
as 30 days.
The President has recognized the importance of providing SSA with
sufficient resources to enable SSA to implement the Commissioner's plan
to improve the Social Security disability program. NTEU asks that the
Congress approve the budget requests of the President regarding the
funding of the Commissioner's Approach to Disability Adjudication.
However, as good as the Commissioner's plan is, it does not provide
immediate relief for those currently waiting for a disability decision.
Unfortunately, it will be October 2005 at the earliest before the
Commissioner's recommendations can be implemented. In the meantime, the
backlog will continue to grow.
Given the present state of resources, the current workload, and the
direction that the Commissioner's Approach is taking the Agency, the
Commissioner should immediately reinstate the original Senior Attorney
Program. In addition to making a positive, immediate, and effective
impact on the backlog, it would act as a good transition to the
Reviewing Official. All qualified OHA Attorney Advisors should be
empowered to issue fully favorable on-the-record decisions. During the
period from 1995 to 1999 Senior Attorneys issued over 220,000 fully
favorable on-the-record decisions, and the cases pending at OHA hearing
offices fell from over 550,000 cases to 311,000 cases. A well designed
and well managed Senior Attorney program should be able to process at
least 60,000 fully favorable reversals in a year without reducing the
number of ALJ decisions or affecting the overall reversal rate at OHA.
Implementing the original Senior Attorney Program would require
limited new hiring and the impact on the backlog would be swift and
striking. I strongly recommend that this Committee both carefully
review and embrace the Commissioner's new disability plan and also
encourage SSA to implement the original Senior Attorney Program once
again without delay.
Thank you very much for your attention to these issues. I very much
appreciate the opportunity to share this testimony with you.
______
Prepared Statement of the Oncology Nursing Society
The Oncology Nursing Society (ONS) appreciates the opportunity to
submit written comments for the record regarding funding for cancer and
nursing related programs in fiscal year 2005. ONS, the largest
professional oncology group in the United States composed of more than
30,000 nurses and other health professionals, exists to promote
excellence in oncology nursing and the provision of quality care to
those individuals affected by cancer. As part of its mission, the
Society honors and maintains nursing's historical and essential
commitment to advocacy for the public good.
This year more than 1.3 million Americans will be diagnosed with
cancer and more than 560,000 will lose their battle with this terrible
disease. Despite these grim statistics, significant gains in the War
Against Cancer have been made through our nation's investment in cancer
research and its application. Research holds the key to improved cancer
prevention, early detection, diagnosis, and treatment but such
breakthroughs are meaningless unless we can deliver them to all
Americans in need. One barrier to ensuring that all people benefit from
breakthroughs in cancer research is that recent studies have reported
126,000 registered nurse vacancies in hospitals and 13,900 registered
nurse vacancies in nursing homes.
To ensure that all people with cancer have access to the
comprehensive, quality care they need and deserve, ONS advocates
ongoing and significant federal funding for cancer research and
application, as well as programs to help ensure an adequate oncology
nursing workforce to care for people with cancer. The Society stands
ready to work with policymakers at the local, state, and federal levels
to advance policies and programs that will reduce and prevent suffering
from cancer and sustain and strengthen the nation's nursing workforce.
SECURING AND MAINTAINING AN ADEQUATE ONCOLOGY NURSING WORKFORCE
Over the last 10 years, the setting in which treatment for cancer
is provided has changed dramatically. An estimated 80 percent of all
Americans receive cancer care in community settings including cancer
centers, physicians' offices, and hospital outpatient departments.
Treatment regimens are as complex, if not more so, than regimens given
in the inpatient setting a few short years ago. Oncology nurses are on
the front lines in the provision of quality cancer care for individuals
with cancer--administering chemotherapy, managing patient therapies and
side-effects, working with insurance companies to ensure that patients
receive the appropriate treatment, providing counseling to patients and
family members, and engaging in myriad other activities on behalf of
people with cancer and their families.
Overall, age is the number one risk factor for developing cancer.
Approximately 77 percent of all cancers are diagnosed at age 55 and
older. Currently, Medicare beneficiaries account for more than 50
percent of all cancer diagnoses and 64 percent of cancer deaths. Of
serious concern is that over the next 10 to 15 years the number of
Medicare beneficiaries with cancer is estimated to double while more
than 1.1 million registered nurse job openings will need to be filled
by 2012 to meet growing patient demand and replace retiring nurses.
With an increasing number of people with cancer needing high quality
health care coupled with an inadequate nursing workforce, our nation
could quickly face a cancer care crisis of serious proportion with
limited access to quality cancer care, particularly in traditionally
underserved areas. A study in the New England Journal of Medicine found
that nursing shortages in hospitals are associated with a higher risk
of complications--such as urinary infections and pneumonia, longer
hospital stays, and even patient death. Without an adequate supply of
nurses, there will not be enough qualified oncology nurses to provide
the quality cancer care to a growing population of people in need and
patient health and well being could suffer.
Further, of additional concern is that our nation also will have a
shortage of nurses available and able to conduct cancer research and
clinical trials. With a shortage of nurses in cancer research, our war
against cancer will take longer because of unfulfilled staffing needs
coupled with the reality that in some practices and cancer centers
resources could be funneled away from cancer research to pay for the
hiring and retention of oncology nurses to provide direct patient care.
Without a sufficient supply of trained, educated, and experienced
oncology nurses, our nation will falter in its delivery--or
application--of the benefits from our federal investment in research.
ONS has joined with others in the nursing community in advocating
$205 million as the fiscal year 2005 funding level necessary to support
implementation of the Nurse Reinvestment Act and the range of nursing
workforce programs housed at the U.S. Health Resources and Services
Administration (HRSA). Enacted in 2002, the Nurse Reinvestment Act
included new and expanded initiatives, including loan forgiveness,
scholarships, career ladder opportunities, and public service
announcements to advance nursing as a career. Despite the enactment of
this critical measure, HRSA fails to have the resources necessary to
meet the current and growing demands for our nation's nursing
workforce. For example, in fiscal year 2003 HRSA received 8,321
applications for the Nurse Education Loan Repayment Program but only
had funding to award 602--a rate of 7.2 percent. Also in fiscal year
2003, the agency received 4,512 applications for the Nursing
Scholarship Program but only could fund 94--a rate of 2.1 percent.
Further exacerbating the current situation is that nursing programs
turned away more than 11,000 qualified students last fall, in part due
to a shortage of faculty. If funded sufficiently, the components and
programs of the Nurse Reinvestment Act would help address the multiple
factors contributing to the nationwide nursing shortage, including the
shortage of faculty, decline in nursing student enrollments, and poor
public perception of nursing as a viable and worthwhile profession.
ONS strongly urges Congress to provide HRSA with a minimum of $205
million in fiscal year 2005 to ensure that the agency has the resources
necessary to fund a higher rate of Nurse Education Loan Repayment and
Nursing Scholarship applications as well as implement other essential
endeavors to sustain and boost our nation's nursing workforce. Nurses--
along with patients, family members, hospitals, and others--have joined
together in calling upon Congress to provide this essential level of
funding. One Voice Against Cancer (OVAC)--a collaboration of more than
50 national nonprofit organizations representing millions of
Americans--has added a request of $205 million for the Nurse
Reinvestment Act funding to its fiscal year 2005 appropriations
advocacy agenda. ONS and its allies have serious concerns that without
full funding, the ``Nurse Reinvestment Act'' will prove an empty
promise; the current and expected nursing shortage will worsen and
people will not be have access to the quality cancer care they need and
deserve.
BOOST OUR NATION'S INVESTMENT IN CANCER PREVENTION, EARLY DETECTION,
AND AWARENESS
Approximately two-thirds of cancer cases are preventable through
lifestyle and behavioral factors and improved practice of cancer
screening. Although the potential for reducing the human, economic, and
social costs of cancer by focusing on prevention and early detection
efforts remains great, our nation does not invest sufficiently in these
strategies. While as a nation we spend almost $1 trillion a year on our
health care system, we only allocate about 1 percent of that amount for
population-based prevention. By the year 2020, cancer and other chronic
disease expenditures will reach $1 trillion or 80 percent of health
care costs. The nation must make significant and unprecedented federal
investments today to address the burden of cancer and other chronic
diseases and to reduce the demand on the healthcare system and diminish
suffering in our nation both for today and tomorrow.
As the nation's leading prevention agency, the Centers for Disease
Control and Prevention (CDC) plays an important role in translating and
delivering at the community level what is learned from research--
especially ensuring that those populations disproportionately affected
by cancer receive the benefits of our nation's investment in medical
research. Therefore, ONS joins with our partners in the cancer
community--including One Voice Against Cancer--in calling on Congress
to provide additional resources for physical activity, nutrition, and
tobacco control programs and other cancer-related screening,
prevention, and public health education efforts supported through the
CDC to support and expand much-needed and proven effective cancer
prevention, early detection, and risk reduction efforts. Specifically,
ONS advocates:
--$250 million for the National Breast and Cervical Cancer Early
Detection Program;
--$65 million for the National Cancer Registries Program:
--$25 million for the Colorectal Cancer Prevention and Control
Initiative;
--$25 million for the Comprehensive Cancer Control Initiative;
--$20 million for the Prostate Cancer Control Initiative;
--$10 million for the National Skin Cancer Prevention Education
Program;
--$9 million for the Ovarian Cancer Control Initiative;
--$5 million for the Geraldine Ferraro Blood Cancer Program;
--$130 million for the National Tobacco Control Program; and
--$70 million for the Nutrition, Physical Activity, and Obesity
Program.
SUSTAIN AND SEIZE CANCER RESEARCH OPPORTUNITIES
Our nation has benefited immensely from our past federal investment
in biomedical research at the National Institutes of Health (NIH). ONS
has joined with the rest of the cancer community in advocating $30.19
billion for the NIH in fiscal year 2005. This increase of 8.5 percent
over fiscal year 2004 funding will allow NIH to sustain and build on
its research progress resulting from the recent NIH budget doubling
effort while avoiding the severe disruption to that progress that would
result from a minimal increase.
Cancer research is producing extraordinary breakthroughs--leading
to new therapies that translate into longer survival and improved
quality of life for cancer patients. We have seen extraordinary
advances in cancer research resulting from our national investment that
have produced effective prevention, early detection and treatment
methods for many cancers. To that end, ONS calls upon Congress to
allocate $6.2 billion to the National Cancer Institute (NCI) in fiscal
year 2005 as recommended by the NCI Director in the Bypass Budget
submitted to Congress annually under the requirements of the National
Cancer Act of 1971. The NCI Bypass Budget represents the best
estimation of the scientific community regarding the resources needed
to continue our battle against cancer.
The National Institute of Nursing Research (NINR) supports basic
and clinical research to establish a scientific basis for the care of
individuals across the life span--from management of patients during
illness and recovery to the reduction of risks for disease and
disability and the promotion of healthy lifestyles. These efforts are
crucial in translating scientific advances into cost-effective health
care that does not compromise quality of care for patients.
Additionally, NINR fosters collaborations with many other disciplines
in areas of mutual interest such as long-term care for older people,
the special needs of women across the life span, bioethical issues
associated with genetic testing and counseling, and the impact of
environmental influences on risk factors for chronic illnesses such as
cancer. ONS joins with the nursing community in advocating an
allocation of $160 million for NINR in fiscal year 2005.
CONCLUSION
ONS stands ready to work with policymakers to advance policies and
support programs that will reduce and prevent suffering from cancer
this year and sustain and strengthen our nation's nursing workforce.
Moreover, ONS maintains a strong commitment to working with Members of
Congress, other nursing societies, patient organizations, and other
stakeholders to ensure that the oncology nurses of today continue to
practice tomorrow and that we recruit and retain new oncology nurses to
meet the unfortunate growing demand that we will face as the baby boom
generation ages. We thank you for this opportunity to discuss the
funding levels necessary to ensure that our nation has a sufficient
nursing workforce to care for the patients of today and tomorrow and
that our nation continues to make gains in our fight against cancer.
______
Prepared Statement of the Association of Women's Health, Obstetric and
Neonatal Nurses
The Association of Women's Health, Obstetric and Neonatal Nurses
(AWHONN) appreciates the opportunity to comment on the fiscal year 2005
appropriations for nursing education, research, and workforce programs,
as well as programs designed to improve maternal and child health.
AWHONN is a membership organization of 22,000 nurses whose mission is
to promote the health of women and newborns. AWHONN members are
registered nurses, nurse practitioners, certified nurse-midwives, and
clinical nurse specialists who work in hospitals, physicians' offices,
universities and community clinics across North America as well as in
the Armed Forces around the world.
AWHONN appreciates the support that this Subcommittee has provided
for nursing education, research and workforce programs, as well as
maternal and child health programs in the past. We realize that there
are many competing priorities for the Subcommittee members, and we
admire your consistent support.
GROWING NURSING SHORTAGE
AWHONN supports the advancement of quality care through an adequate
nurse workforce. Data from the Bureau of Health Professions, Division
of Nursing's National Sample Survey of Registered Nurses--February
2002, confirm that of the approximate 2.7 million registered nurses in
the nation, only about 82 percent of these nurses were working full-
time or part-time in nursing. The increase in the number of licensed
RNs that was reported from 1996-2000 was the lowest increase reported
in previous national surveys. In addition to the shrinking pipeline of
nurses coming into the program, the dominant factor in this shortage is
the impending retirement of up to 40 percent of the workforce by 2010
or soon thereafter. This will occur at the same time that the needs of
the aging baby boomer population will markedly increase demand for
health care services and the services of registered nurses.
This critical demand is reinforced by the fact that in February
2004, the U.S. Bureau of Labor released statistics detailing how
registered nurses have the largest projected 10-year job growth in the
United States. Labor projects a need for 2.9 million nurses in 2012, up
from 2.3 million actively working nurses that was projected in 2002. As
a result, it will take long-term planning and innovative initiatives at
the local, state and federal level to assure an adequate supply of a
qualified nurse workforce for the nation.
Nurse Workforce Development Programs
AWHONN recommends a total of $205 million for fiscal year
2005 to fund the Nurse Workforce Development
programs in Title VIII
The Nurse Education Act (Public Health Service Act, Title VIII),
enacted in 1964, represents the only comprehensive federal legislation
to provide funds for nursing education. The programs authorized in this
portion of Public Law 105-392 help schools of nursing and nursing
students prepare to meet patient needs in a changing health care
delivery system, favoring programs in institutions that train nurses
for practice in medically underserved communities and Health
Professional Shortage Areas.
Reauthorized as the Nursing Workforce Development section in 1998,
the new NEA gives the Department of Health and Human Services more
discretion over the focus of federal spending, while keeping with
previous goals. In 2002 Congress enacted the Nurse Reinvestment Act
which provides funding for new and expanded programs. These programs
include scholarships, career ladders, internships and residencies,
retention programs and faculty loans designed to encourage students to
consider nursing, keep nurses in nursing and ensure that nurse
educators are plentiful enough to educate future nurses that we
desperately need. The new programs received an initial appropriation of
$20 million in fiscal year 2003. This appropriation was in addition to
$93 million in funding provided for existing Title VIII programming.
Unfortunately, due to limited funding in the first 2 years of the new
authorization the loans and scholarships programs have not been
successful in providing support to students in nursing schools. In the
first year, only 574 loan repayment contracts were made nationally,
averaging roughly 11 loan repayment agreements per state and less than
2 percent of all scholarship applicants were funded.
The shortage of registered nurses and the effect of the shortage on
nurse staffing and patient safety demand a significant increase in
funding for these nurse education programs. Nursing is the largest
health profession with over 2.7 million nurses, yet only one-tenth of 1
percent of the federal health funding of the nation is directed to
nursing education. A significant increase in funding for these programs
would lay the groundwork to expand the nursing workforce, through
education, clinical training and retention programs, in order to
address some of the serious nursing shortage issues. This investment in
nursing education and retention will ultimately benefit us all through
improved patient care and health outcomes.
The nursing shortage is not confined solely to care providers;
there is also a growing, significant shortage of nurse faculty. The
American Association of Colleges of Nursing (AACN) reports that the
average age of nursing professors is 52, and for associate professors
the average age is 49. The impending retirement of these seasoned
educators will impact the ability of our schools and universities to
meet the educational health care needs of the nation. In addition, each
year nearly 1,800 full-time faculty members leave their positions while
only 350 to 400 nursing students receive doctoral degrees. According to
AACN, U.S. nursing schools turned away over 11,000 qualified applicants
to baccalaureate nursing programs in 2003 due to insufficient faculty,
clinical sites, classroom space, and budget constraints. While the
capacity to implement faculty development is currently available
through Section 811 and Section 831, adequate funding and direction is
needed to ensure that these programs are fully operational. Options to
provide support for full-time doctoral study are essential to rapidly
prepare the nurse educators of the future. AWHONN suggests that a
portion of the funds be allocated for faculty development and
mentoring. Further, AWHONN recognizes the importance of appropriate
investments in advanced practice nursing programs. As in other
professions the advanced degree has become a necessary achievement for
career advancement and registered nurses who pursue the MSN degree are
a part of the cadre of nurses who go on to become faculty. Our nation
does need more nurses with basic training to enter the field, but
focusing only on these nurses only addresses half the problem. The
nursing shortage encompasses nursing faculty--advanced practice nursing
and basic nursing must both receive additional funding, but not one at
the expense of the other.
Maternal and Child Health Bureau
AWHONN recommends $850 million in funding in fiscal year
2005 for the Maternal and Child Health Bureau
This program provides comprehensive, preventive care for mothers
and young children, as well as an array of coordinated services for
children with special needs. In fact, the Maternal Child Health Block
Grant (MCH) serves over 80 percent of all infants in the United States,
half of all pregnant women, and 20 percent of all children.
MCH programs are facing increased demands for services due to
continued growth in the Children's Health Insurance Program, which in
turn identifies more children who are eligible for other MCH Services.
Title V complements Medicaid and the State Children's Health Insurance
Program by providing ``wrap-around'' services and enhanced access to
care in underserved areas. Additional funding would give states the
resources they need to expand prenatal and infancy home visitation
programs, an approach that has been shown, in NINR research, to improve
the prenatal health-related behavior of women and reduce rates of child
abuse and neglect as well as maternal welfare dependence.
Indian Health Service
AWHONN recommends an fiscal year 2005 appropriation of
$5.54 billion for IHS.
The Indian Health Service (IHS) is the principal Federal health
care provider and health advocate for Indian people with the goal of
``ensur[ing] that comprehensive, culturally acceptable personal and
public health services are available and accessible to all American
Indian and Alaska Native people.'' IHS is tasked with an enormous
responsibility in providing care to over half of the American Indian
population.
The American Indian and Alaska Native people have long experienced
lower health status when compared with other Americans. Lower life
expectancy and the disproportionate disease burden exist perhaps
because of inadequate education, disproportionate poverty,
discrimination in the delivery of health services, and cultural
differences. These are broad quality of life issues rooted in economic
adversity and poor social conditions.
A recent study of federal health care spending per capita found
that the United States spends $3,803 per year per federal prisoner,
while spending about half that amount per year, per Native American:
$1,914. per capita health care spending for the U.S. general population
is $5,065 per year. A significant increase in funding over fiscal year
2004 spending levels is necessary for the Federal government to fulfill
its responsibility to Indian Country and achieve its stated goals.
While the nursing shortage continues nationwide, IHS has been
disproportionately impacted by the lack of RNs. IHS nurses are older,
with an average age of 48 and nearly 80 percent of RNs are over the age
of 40, and the average vacancy rate for RNs is 14 percent. IHS
administers three interrelated scholarship programs designed to meet
the health professional staffing needs of IHS and other health programs
serving Indian people. These programs are severely under-funded.
Targeted resources need to be invested in the IHS health professions
programs in order to recruit and retain registered nurses in Indian
Country.
Additionally, Section 112 of the Indian Health Care Improvement
Act, Public Law 94-437, authorizes grants to public or private schools
of nursing, tribally-controlled community colleges and tribally-
controlled post secondary vocational institutions for the purpose of
recruiting, training and increasing the number of professional nurses
who deliver health care services to Indian people. On average, Section
112 programs provide five undergraduate scholarships per year and two
master's program scholarships. This important program should be
expanded to provide many more scholarships, both at the undergraduate
and graduate levels, in an effort to offer meaningful relief to the
nursing shortage for IHS healthcare providers and the patients they
serve.
National Institute of Nursing Research (NINR)
AWHONN recommends an increase of $25 million over fiscal
year 2004 funding levels for the NINR, resulting in
an fiscal year 2005 appropriation of $160 million
NINR engages in significant research affecting areas such as:
health disparities in ethnic groups, training opportunities for
management of patient care and recovery, and telehealth interventions
in rural/underserved populations. These research programs directly help
patients and families and contribute to decreased medical costs and
increased quality of patient care. This research allows us to refine
the practice and provide quality patient care in its current
challenging environment.
NINR research improves health outcomes for women. Recent public
awareness campaigns target differences in the manifestation of
cardiovascular disease between men and women. The differing symptoms
are the source of many missed diagnostic opportunities among women
suffering from the disease, which is the primary killer of American
women. In a study funded by NINR, researchers were able to
qualitatively analyze the intensity of pain and limitation of activity
experienced by women suffering from angina, both of which were found to
be of greater intensity than that experienced by men. The study
concluded that the gender variation could significantly impact
diagnosis and treatment of female patients suffering from related
cardiovascular problems.
Because of the emphasis on biomedical research in this country,
there are few sources of funds for high-quality behavioral research for
nursing other than NINR. It is critical that we increase funding in
this area in an effort to improve the consumer's experience with the
health care system, optimize patient outcomes and decrease the need for
extended hospitalization.
National Institute of Child and Human Development (NICHD)
AWHONN supports a 10 percent increase in funding for NICHD
for fiscal year 2005, bringing the appropriation to
$1.315 billion
NICHD seeks to ensure that every baby is born healthy, that women
suffer no adverse consequences from pregnancy, and that all children
have the opportunity to fulfill their potential for a healthy and
productive life unhampered by disease or disability. With increased
funding NICHD could expand its use of the NICHD Maternal-Fetal Medicine
Network to study ways to reduce the incidence of low birth weight.
Prematurity/low birthweight is the second leading cause of infant
mortality in the United States and the leading cause of death among
African American infants. AWHONN, like many organizations directly
involved in initiates to improve the health of women and newborns,
looks to NICHD to provide national initiatives, such as the Maternal-
Fetal Medicine Network to assist with the care of pregnant women and
babies.
Recently NICHD announced the publication of research that led to
the finding of predictors of preeclampsia, a life-threatening
complication impacting 5 percent of all pregnancies. Abnormal levels of
two molecules found in the blood, soluble fms-like tyrosine kinase 1
(sFlt-1) and placental growth factor (PlGF), seemed to predict the
development of preeclampsia. This finding has been touted as the most
promising lead yet discovered in the effort to prevent and cure
preeclampsia.
National Institutes of Environmental Health Sciences (NIEHS)
AWHONN supports an 8 percent increase in funding for NIEHS
for fiscal year 2005, bringing the appropriation to
$680 million
Research conducted by the NIEHS plays a critical role in what we
know about the relationship between our environmental exposures and
disease onset. Through the research sponsored by this Institute, we
know that Parkinson's disease, breast cancer, birth defects,
miscarriage, delayed or diminished cognitive function, infertility,
asthma and many other diseases and ailments have confirmed
environmental triggers. Our expanded knowledge, as a result, allows
both policy makers and the general public to make important decisions
about how to reduce toxin exposure and reduce the risk of disease and
other negative health outcomes.
One impressive collaborative research project spearheaded by the
NIEHS is the recent development of Breast Cancer and the Environment
Research Centers. These centers, co-funded by the National Cancer
Institute, will study the prenatal-to-adult environmental exposures
that may predispose a woman to breast cancer. Recognizing that one in
eight women in the United States can expect to have breast cancer in
her lifetime, and that the causes of most of these cases are not known;
the centers will enroll different ethnic groups of young girls and
study their life exposures to a wide variety of environmental,
nutritional and social factors that impact puberty.
Centers for Disease Control and Prevention (CDC)
AWHONN recommends an fiscal year 2005 appropriation of $7.9
billion for the CDC
For nearly 60 years, the Centers for Disease Control and Prevention
(CDC) has evolved to assume responsibility for programs in infectious
disease surveillance, control and prevention, injury control, health in
the workplace, prevention of heart disease, cancer, stroke, obesity and
other chronic diseases, improvements in nutrition and immunization,
environmental effects on health, prevention of birth defects,
laboratory analyses, outbreak investigation and epidemiology training,
and data collection and analysis on a host of vital statistics and
other health indicators. Now more than ever, CDC's role in protecting
the nation's health through prevention has become evident as we address
issues of terrorism, emergency preparedness and health system capacity
and infrastructure. Increased funding for CDC is critical.
For over 30 years, CDC has been deeply involved in the prevention
of birth defects through programs like the Folic Acid Education
Campaign and the new National Center on Birth Defects and Developmental
Disabilities (NCBDDD). The public health impact of birth defects is
tremendous. Of the 4 million babies born each year in the United
States, approximately 150,000 are born with a serious birth defect.
According to CDC, the lifetime costs of caring for infants born in
1992, with at least one birth defect \1\ or cerebral palsy was about $8
billion. The emotional and financial burden for the families with
affected children is devastating. CDC funds several programs critical
to reducing the number of children born with birth defects.
---------------------------------------------------------------------------
\1\ These birth defects include: Spina bifida, truncus arteriosus,
single ventricle, transposition/double outlet right ventricle,
Tetralogy of Fallot, tracheo-esophageal fistula, colorectal atresia,
cleft lip or palate, atresia/stenosis of small intestine, renal
agenesis, urinary obstruction, lower-limb reduction, upper-limb
reduction, omphalocele, gastroschisis, Down syndrome, and diaphragmatic
hernia.
---------------------------------------------------------------------------
Heart disease and stroke are the first and third leading causes of
death in the United States, causing one death every 33 seconds and $298
billion a year in healthcare costs and lost productivity, according to
CDC estimates. Women are most commonly misdiagnosed for cardiovascular
disease and nearly 8 million women are currently living with
cardiovascular disease. Cardiovascular disease kills nearly half of all
American women. Additionally, 61 percent of American adults are
overweight or obese and nearly 14 percent of children and adolescents
are overweight. Obesity is considered a major public health problem
because it serves as the gateway disease for many other illnesses
including but not limited to: depression, type 2 diabetes,
hypertension, congestive heart failure, stroke, poor female
reproductive health and pregnancy complications. These are but two
examples of illnesses with programmatic public health funding through
CDC. Any cuts to these programs will potentially leave millions of
Americans without primary prevention programs that ultimately save
lives and money. We respectfully request that you provide CDC chronic
disease prevention and health promotion programs with $1.1 billion to
ensure that these programs have the resources necessary to translate
preventive health research into practice. This investment will save
lives and billions in health care costs and productivity.
Please find below a summary of AWHONN formal funding
recommendations for these and other federal health programs.
----------------------------------------------------------------------------------------------------------------
President's
Programmatic area Final fiscal year budget fiscal AWHONN's request
2004 year 2005
----------------------------------------------------------------------------------------------------------------
Nurse Workforce Development Programs................... $142,763,000 $147,000,000 $205,000,000
Maternal & Child Health Block Grant.................... 730,000,000 730,000,000 850,000,000
Indian Health Service.................................. 3,671,000,000 3,356,000,000 5,540,000,000
Title X--Family Planning............................... 278,000,000 278,000,000 350,000,000
Newborn Hearing Screening.............................. 13,000,000 ................. 13,000,000
AHRQ................................................... 305,000,000 305,000,000 443,000,000
NIH.................................................... 28,041,000,000 28,805,000,000 31,685,500,000
NINR................................................... 135,000,000 139,000,000 160,000,000
NICHD.................................................. 1,242,000,000 1,281,000,000 1,315,000,000
NIEHS.................................................. 631,000,000 650,000,000 680,000,000
CDC.................................................... 6,972,000,000 6,859,000,000 7,900,000,000
----------------------------------------------------------------------------------------------------------------
Thank you for the opportunity to submit testimony on these critical
areas of funding.
Contact: Lisa M. Greenhill, MPA, Legislative Manager Department of
Public Affairs Association of Women's Health, Obstetric and Neonatal
Nurses 2000 L St. NW, Suite 740, Washington, DC 20036 (202) 261-2402
[email protected]
______
Prepared Statement of the American Heart Association
Heart disease, stroke and other cardiovascular diseases kill more
Americans each year than the next 5 leading causes of death combined,
putting people of all ages at risk. Cardiovascular diseases remain our
nation's No. 1 killer and a major cause of disability. We are concerned
that our government is still not devoting sufficient resources for
research and prevention to America's No. 1 killer--heart disease--and
to our country's No. 3 killer--stroke.
STILL NO. 1--AN UNHAPPY DISTINCTION
Cardiovascular diseases represent a continuing crisis of pandemic
proportions. More than 64 million Americans suffer from these diseases,
and risk factors are on the rise. While smoking is the top preventable
cause of death, the obesity epidemic is catching up. Obesity rates are
rising in adults and in children. Also, an estimated 50 million
Americans have high blood pressure, 37 million adults have high
cholesterol, and more than 11 million have diagnosed diabetes. Also,
cardiovascular diseases cost Americans more than any other disease--an
estimated $368 billion in medical expenses and lost productivity in
2004. Heart disease is the major cause of premature, permanent
disability of American workers, accounting for about 20 percent of
Social Security disability payments. Stroke is a main cause of
disability. Heart defects are the most common birth defect and cause
more infant deaths than any other birth defect.
YOU ARE PART OF THE SOLUTION
Now is the time to capitalize on progress in understanding heart
disease, stroke and other cardiovascular diseases. Promising, cost-
effective breakthroughs in treatment and prevention are on the horizon.
A continued, sustained investment in the NIH and appropriate funding
for NIH heart disease and stroke will support promising and critically
needed new initiatives and the translation of that research into useful
clinical and state programs. For fiscal year 2005, we urge you to:
Appropriate $30.6 billion for the National Institutes of Health (NIH)--
to provide a continued, sustained investment in life-saving
medical research
NIH research provides new treatment and prevention strategies,
creates jobs, and maintains America's status as the world leader in the
biotechnology and pharmaceutical industries.
Provide $2.5 billion for NIH heart research and $410 million for NIH
stroke research
Researchers are on the brink of advances to enhance prevention and
to provide new treatments so you and your loved ones can be spared the
pain and suffering of heart disease and stroke.
Allot $80 million for Heart Disease and Stroke for the CDC to expand,
intensify and coordinate prevention like expanding the State
Heart Disease and Stroke Prevention Program and augmenting the
Paul Coverdell National Acute Stroke Registry
Science must be translated into state programs that hearten
Americans to make healthy lifestyle choices to avert and control heart
disease and stroke and track and improve stroke care delivery.
Support $45 million to continue to help our communities treat cardiac
arrest in time to save victims' lives by initiating automated
external defibrillator (AEDs) programs
The Rural Access to Emergency Devices Act (part of Public Law 106-
505) and the Community Access to Emergency Defibrillation Act (part of
Public Law 107-188) help communities purchase AEDs and train emergency
and lay responders in their use.
HEART AND STROKE RESEARCH BENEFITS ALL AMERICANS
The doubling of the NIH budget has led to new breakthroughs in
treating heart disease and stroke patients and their risk factors for
these diseases. Several examples follow.
High Blood Pressure.--A clinical trial concluded that customary
diuretic drugs should be the first treatment for lowering blood
pressure. The diuretic tested as well or better than some newer types
of drugs in preventing high blood pressure complications, including
fatal and non-fatal heart attacks, strokes and heart failure. The cost
implications are significant because diuretics cost a fraction of the
price of the newer drugs.
Hormone Replacement Therapy.--Researchers concluded that long-term
estrogen plus progestin therapy risks outweigh its protective benefits.
Women study participants taking estrogen plus progestin had increased
risks of heart attack, stroke, breast cancer and blood clots.
Heart Attack.--More than 5 million patients with chest pain visit
emergency departments each year, but only about 40 percent can be
immediately diagnosed with heart attack using standard diagnostic
tests. Results from a collaborative study using advanced, non-invasive
magnetic resonance imaging showed that MRI can detect a heart attack in
emergency room patients with chest pain more accurately and faster than
standard diagnostic tests. Since patients can be scanned in under 40
minutes, MRI technology will save lives and reduce disability among
survivors by allowing doctors to diagnose heart attacks and start
treatment faster.
Recurrent Stroke Prevention.--Results of two clinical trials showed
that aspirin was just as effective in preventing recurrent strokes as
expensive drugs. Outcomes of the first trial indicated that aspirin
appears to be as effective as warfarin in preventing a second stroke,
when heart conditions such as atrial fibrillation, a common heart
rhythm and rate problem, are not present. Results from the second study
showed that aspirin is as effective as ticlopidine, a type of clot
inhibitor, in preventing a second stroke in African-Americans who have
twice the risk of suffering or dying from a stroke, compared to whites.
These results will dramatically change physician care in preventing
second strokes in the general public and in African-Americans. Given
the lower cost, ease of administration and reduced side effects,
compared to warfarin and ticlopidine, aspirin will be a cost-effective
method in preventing subsequent strokes.
We join other members of the research community in advocating for
an fiscal year 2005 appropriation of $30.6 billion for the NIH to
provide a continued, sustained investment in life-saving medical
research and support investigation into new therapies. The NIH budget
for heart disease and stroke remains disproportionately under funded
compared to the enormous burden of these diseases and the numerous
promising scientific opportunities that could advance the fight against
these disorders. Heart disease, stroke and other cardiovascular
diseases meet the NIH's criteria for priority setting (public health
needs, scientific quality research, scientific progress potential,
portfolio diversification and adequate infrastructure support), but the
NIH still invests only 7 percent of its budget on heart research and a
mere 1 percent on stroke research. We have a particular interest in
individual NIH components that relate directly to our mission. Our
funding recommendations for these Institutes follow.
HEART RESEARCH CHALLENGES AND OPPORTUNITIES FOR NHLBI
Advances have been made by more than 50 years of American Heart
Association-funded research and more than a half-century of investment
by Congress in the National Heart, Lung, and Blood Institute. While
more people are surviving heart disease and stroke, they can cause
permanent disability, requiring costly medical care and loss of
productivity and quality of life.
We urge this Committee to appropriate funding for the NHLBI and for
its heart disease and stroke-related efforts to support and expand
current activities and to invest in promising and critically needed new
initiatives to aggressively advance the battle against heart disease
and stroke. To accomplish this goal, we advocate an appropriation of
$3.5 billion for the NHLBI, including $2.1 billion for heart disease
and stroke. This added investment is needed to focus on heart disease
and stroke challenges and opportunities. Several of these follow.
Heart Failure Management.--Heart failure is a major cause of
hospitalization and readmission. Medicare recipients represent about 65
percent of repeat hospitalizations within 1 year. Yet, perhaps 50
percent of these hospitalizations are avoidable. Additional funding
would allow the NHLBI to initiate a planned multi-center, randomized
trial to evaluate management strategies for heart failure patients in
terms of their ability to prevent death or hospital readmission. Costs,
quality of life, physician compliance, and patient adherence to
prescribed treatment will also be assessed. This clinical trial will
identify and disseminate useful and effective tools for translation of
proven therapies for heart failure into patient care.
Tissue Engineered Blood Vessel Replacement and Repair.--A need
exists to develop alternatives to natural blood vessels for adults who
endure heart artery bypass surgery and for children born with complex
heart defects who need multiple blood vessel grafts. With increased
funding, this planned initiative will complement exiting tissue
engineered research programs to stimulate efforts to ``grow'' small-
diameter, functional blood vessels.
Cardiovascular Health Study.--Initiated in 1987 to determine risk
factors for development and progression of cardiovascular diseases in
nearly 6,000 Americans age 65 and older, the Cardiovascular Health
Study (CHS) is scheduled to end in 2005. The wide variety and
complexity of data and samples collected in the CHS represent an unique
national research resource. With increased funding, this planned
proposal will stimulate innovative use of CHS data and material,
provide opportunities for open and efficient use of the information for
the entire scientific community; and continue follow-up of study
participants.
Community-Responsive Interventions to Reduce Cardiovascular Risk in
American Indians and Alaskan Natives.--American Indian and Alaska
Native communities bear a disproportionate burden of heart disease,
stroke and other cardiovascular diseases. But, few preventive
interventions have been tested. Tribal leaders have urged that research
in their communities focus on finding solutions for the most serious
issues these populations face, including cardiovascular diseases. To
address the concerns of the tribal leaders, with increased funding,
researchers will evaluate approaches to reducing behavioral
cardiovascular disease risk factors in American Indian and Alaskan
Native populations. A central part of this planned initiative will be
the development of interventions that can be incorporated into
community patient care programs or delivered through other public
health avenues in native communities.
STROKE RESEARCH CHALLENGES AND OPPORTUNITIES FOR NINDS
Stroke is the No. 3 killer of Americans and a major cause of
permanent disability. Many of America's 4.8 million stroke survivors
face debilitating physical and mental impairment, emotional distress
and huge medical costs. About 1 in 4 stroke survivors is permanently
disabled. An estimated 700,000 Americans will suffer a stroke this
year, and nearly 164,000 will die. In addition to the elderly, stroke
also strikes newborns, children and young adults.
We urge you to provide sufficient funding for the NINDS to support
and expand current activities and to invest in promising and critically
needed new initiatives to aggressively prevent stroke, protect the
brain during stroke and enhance rehabilitation. To accomplish this
goal, we advocate for an fiscal year 2005 appropriation of $1.8 billion
for the NINDS, including $204 million for stroke. Some challenges and
opportunities follow:
Strategic Stroke Research Plan.--As a result of congressional
report language during the fiscal year 2001 appropriations process, the
NINDS convened a Stroke Progress Review Group. Their report serves as a
blueprint for a long-range strategic stroke research plan. They
identified serious gaps in stroke knowledge and outlined 5 research
priorities and 7 resource priorities that would spur stroke research.
But, more funding is needed to continue to implement this plan.
Emerging Stroke Risk Factors.--Although more Americans are
controlling major stroke risk factors, such as high blood pressure and
smoking, the number of stroke victims continues to rise. Scientists are
defining new risk factors, re-examining existing ones and reconsidering
the long-held belief that no difference exists in risk between young
and older patients with similar risk factors. Researchers are studying
heart valve disease, irregular heartbeats, the role of inflammation in
damaging arteries, and the long-term effects of high blood pressure.
Increased funding to study these areas may lead to new ways to prevent
stroke.
Therapeutic Strategies for Stroke.--Several major clinical trials
have identified new methods for preventing and treating stroke in high-
risk populations. But, with the increased number of strokes, and with
the disparities in stroke treatment, new ways to prevent strokes, to
raise awareness, and to better treat strokes need to be developed and
evaluated. Funding for new clinical studies is vital for developing
cutting-edge stroke treatment and prevention.
Stroke Education.--Less than 5 percent of patients eligible for
tPA--the only FDA approved emergency treatment for clot-based stroke--
receive it. As a member of the Brain Attack Coalition, a group of
organizations devoted to fighting stroke, we work with the NINDS to
increase public awareness of stroke symptoms and the need to call 9-1-
1. Together, we launched a public education campaign, Know Stroke, Know
the Signs. Act in Time, and we are striving to develop systems to make
tPA available to appropriate patients. When these measures are
implemented, stroke treatment will change from supportive care to early
brain-saving intervention. More funding is needed to educate the public
and health providers about stroke.
RESEARCH IN OTHER NIH INSTITUTES BENEFIT HEART DISEASE AND STROKE
Research seeking to prevent and find better treatments for heart
disease, stroke and other cardiovascular diseases is supported by other
NIH entities like the National Institute on Aging, the National
Institute of Diabetes and Digestive and Kidney Diseases, the National
Institute of Nursing Research and the National Center for Research
Resources. It is important to provide sufficient additional resources
for these entities to continue and expand their critical work.
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
The AHRQ acts as a ``science partner'' with public and private
health care sectors in improving health care quality, reducing health
care costs and broadening access to essential services. They help
develop evidence-based information needed by consumers, providers,
health plans and policymakers to improve health care decision making.
We join with the Friends of AHRQ in advocating for an appropriation of
$443 million for the AHRQ to advance health care quality, cut medical
errors and expand the availability of health outcomes information.
CENTERS FOR DISEASE CONTROL AND PREVENTION
Prevention is the best way to protect Americans' health and ease
the financial burden of disease. Resources must be made available to
bring research to places where heart disease and stroke strike--our
towns and neighborhoods. Setting the pace on prevention, the CDC builds
a bridge between what we learn in the lab and translates findings into
programs in the communities where we live. We advocate an fiscal year
2005 appropriation of $8.1 billion for the CDC, with a $340.5 million
increase for state-based chronic disease prevention and health
promotion programs.
Within that figure, we support an appropriation of $80 million for
the CDC's Heart Disease and Stroke line to better expand, intensify and
coordinate prevention activities against these diseases such as
enhancing the State Heart Disease and Stroke Prevention Program, and
the Paul Coverdell National Acute Stroke Registry. It will also allow
the CDC to start a heart attack and stroke signs health communications
campaign, public and health care provider education, and invest in
standardized methodology on lipid and other measurements. A Heart and
Stroke Division, with ample resources and capacity, would heighten
CDC's efforts on these diseases.
Thanks to this Committee's support since fiscal year 1998, the
CDC's State Heart Disease and Stroke Prevention Program covers 33
states. But, only 11 states receive funding to actually implement
programs to help prevent and control heart disease and stroke. The
remaining 22 states have completed program planning and are prepared
and waiting to implement a state-tailored program. This initiative
allows states to design and/or implement programs to meet state
specific needs to prevent heart disease, stroke and other
cardiovascular diseases. Since cardiovascular diseases remain the No. 1
killer in every state, each state needs funding for basic
implementation of a State Heart Disease and Stroke Prevention Program.
With fiscal year 2004 funding, the CDC can only elevate one state from
planning to program implementation.
An appropriation of $80 million would allow the CDC to expand the
number of states participating in this State Heart Disease and Stroke
Prevention Program by 5 states to conduct a state-tailored heart
disease and stroke prevention plan, and elevate 10 more states from the
planning stage to program implementation and support the other
currently funded states. Also, the CDC would enlarge the Paul Coverdell
National Acute Stroke Registry. This registry tracks and improves
delivery of acute stroke care--care that can mean the difference
between a fairly normal life and long-term disability. The CDC
developed and conducted registry prototypes from 2001-2003 and will
begin to fund three state registries in fiscal year 2004.
We recommend the following fiscal year 2005 funding levels for the
following CDC programs:
--$210 million for the Preventive Health and Health Services Block
Grant;
--$70 million for the Nutrition, Physical Activity and Obesity
Program;
--$125 million for the Youth Media Campaign;
--$82.4 million for the School Health Education Program; and
--$130 million for the Office of Smoking and Health.
HEALTH RESOURCES AND SERVICES ADMINISTRATION
About 340,000 Americans die each year from sudden cardiac arrest.
About 95 percent of the victims die before reaching a hospital. AEDs
are small, easy-to-use devices that can shock a heart back into normal
rhythm and restore life. The Rural Access to Emergency Devices Act and
the Community Access to Emergency Defibrillation Act authorize funds
for state and local governments to start AED programs. States, cities
and towns nationwide eagerly await funds from these vital public health
service grant awards, with available funds far below state requests. An
appropriation of $45 million is required to support these authorized
programs.
DEPARTMENT OF EDUCATION
Physical inactivity is a key risk factor for heart disease and
stroke. Yet, our youth have fewer chances for physical education.
Congress has been appropriating money for the Carol M. White Physical
Education for Progress (PEP) Act to provide funding for school-based
physical education programs, which teach life-long physical activity
habits and thus prevents diseases, like heart disease and stroke. We
advocate for an appropriation of $100 million for PEP.
ACTION NEEDED
Increasing funding for research, prevention and treatment programs
will allow continued strides in the battle against heart disease,
stroke and other cardiovascular diseases. Our government's response to
this challenge will help define the health and well being of Americans
for decades.
______
Prepared Statement of Living Cities: The National Community Development
Initiative
Thank you, Senator Specter and Subcommittee members, for the
opportunity to share with you the views of Living Cities: The National
Community Development Initiative on the administration's fiscal year
2005 budget request for the Office of Community Services within the
U.S. Department of Health and Human Services (HHS.)
Living Cities is a nonprofit consortium of 15 major financial and
philanthropic organizations working to increase the vitality of cities
and improve the lives of people in distressed urban neighborhoods.
These organizations are AXA Community Investment Program, Bank of
America, the Annie E. Casey Foundation, J.P. Morgan Chase & Company,
Deutsche Bank, Fannie Mae Foundation, Robert Wood Johnson Foundation,
W.K. Kellogg Foundation, John S. and James L. Knight Foundation, John
D. and Catherine T. MacArthur Foundation, the McKnight Foundation,
Metropolitan Life Insurance Company, Prudential Financial, the
Rockefeller Foundation, and Surdna Foundation.
In addition, HHS and the U.S. Department of Housing and Urban
Development (HUD) are investment partners in Living Cities. HHS and HUD
representatives attend Living Cities meetings, but are not voting
members of the organization. Neither HUD nor HHS had any involvement in
the preparation of this testimony, and the testimony does not represent
either agency's views in any way. This testimony also does not
represent the views of individual member organizations in Living
Cities. This testimony is entirely and exclusively on behalf of Living
Cities, a stand-alone charitable organization.
Started as NCDI in 1991, Living Cities has worked with the Local
Initiatives Support Corporation (LISC) and The Enterprise Foundation to
make strategic investments in the work of nonprofit community
development corporations (CDCs) in 23 cities--Atlanta, Baltimore,
Boston, Chicago, Cleveland, Columbus, Dallas, Denver, Detroit,
Indianapolis, Kansas City, Los Angeles, Miami, Minneapolis-St. Paul,
Newark, New York City, Philadelphia, Phoenix, Portland, Oregon, San
Antonio, San Francisco Bay Area, Seattle, and Washington, D.C.
The results are tangible. Improvements can be seen in transformed
neighborhoods--new homes, places of employment, and the visible
presence of stronger community organizations. The Living Cities
investment of $254 million has directly supported the creation of
almost 20,000 affordable housing units and 1.7 million square feet of
commercial, industrial and community facilities developed by CDCs, and
has leveraged $2.2 billion, a leverage ratio of nearly 9:1. The federal
investment in the Living Cities initiative over the first decade was
$36 million, achieving a leverage ratio of 61:1 for these federal
dollars.
Based upon our experience, we find that urban neighborhoods have
the workers, purchasing power, and physical assets ready to be tapped
through a combination of public and private investments. That is why
our collaborative is doubling our commitments in the current decade,
increasing our investments by an additional half-billion dollars
between 2001 and 2011.
IMPORTANCE OF ACCOUNTABILITY
We believe that lessons can be drawn from Living Cities' experience
of investing in distressed urban neighborhoods, useful lessons for
policy and funding decisions to strengthen distressed communities
nationwide. Like this Subcommittee, we demand individual accountability
and results from the entities that receive Living Cities resources.
Since our inception, we have engaged outside experts to take a hard
look at what CDCs are achieving. We are glad to share the results of
these studies with the Subcommittee.
Beyond our own research, two federal agencies, the General
Accounting Office and the Office of Management and Budget, this year
applauded the successful use of federal NCDI/Section 4 funds to
strengthen CDCs by improving their internal management, increasing
their capacity, and widening their impact.
HHS/OCS: A VITAL PARTNER IN COMMUNITY REVITALIZATION
The history of CDCs is well known. CDCs began forming in the 1960s
to address the failure of mainstream government and market structures
to provide decent housing, safe neighborhoods, good jobs, and resident
participation in planning for their own future. From the outset of the
CDC movement, communities that were served ranged from a few square
blocks in a single urban neighborhood to multi-county rural areas.
Target populations have been equally diverse--including all races and
ethnic groups, farmers, immigrants, welfare recipients, small business
owners, juveniles, the homeless. What has been consistent among CDCs is
that each one has come from and represents a community, and each one
has harnessed resources from both the public and private sectors of the
economy.
Different administrations have lent their support to CDCs over the
decades. During the 1960s, CDCs were viewed as complementary to
government. Their role was to encourage neighborhood development,
promote anti-poverty strategies, and deliver social services--with
generous federal support provided to fuel them. During the Reagan
years, CDCs came to be seen by some as alternatives to government. CDCs
developed stronger alliances with state and local governments and with
private sector partners. These alliances expanded the impact of CDCs.
By the 1990s, CDCs were viewed as playing a dual role--as complementary
to government and as enhancements to markets.
As you know, the Department of Health and Human Services, Office of
Community Services, Community Services Block Grant Act Secretary's
Discretionary Fund for Community Economic Development is a significant
program of federal assistance to CDCs. This program has been a resource
that is critical to the success of community development, a resource
that needs to continue.
We focus here on the Discretionary Grant Program of the Office of
Community Services, because this program has stood the test of time and
has proven to be very successful in using federal dollars to leverage
private sector investments to create jobs through economic development
projects sponsored by CDCs. This success is illustrated by the
following examples of economic development projects selected from some
of the CDCs and cities in which Living Cities invests.
Asociacion de Puertorriquenos en Marcha, Inc. in Philadelphia
Received a $500,000 grant from the Office of Community Services
that leveraged investment to support $5,100,000 in total development
costs for the Gateway Plaza in Philadelphia.
The OCS grant created 125 jobs.
Abyssinian Development Corporation in New York City
Received a $500,000 grant from the Office of Community Services
that leveraged investment to support $16,000,000 in total development
costs for the Pathmark Supercenter.
The OCS grant created 275 jobs.
Northeast Neighborhood Development in Cleveland
Received a predevelopment grant of $75,000 to perform market and
business studies on the potential for improving the retail climate of a
key intersection in its community.
While the program is still underway, the OCS grant has already
created 10-15 jobs.
Vermont Slauson Economic Development Corporation in Los Angeles
Received a $450,000 grant from the Office of Community Services
that leveraged investment to support $1,200,000 in total development
costs for the Ranch Markets project.
The OCS grant created 70 jobs.
Bethel New Life in Chicago
Received a $700,000 grant from the Office of Community Services
that leveraged investment to support $3,225,000 in total development
costs for the Material Recovery Facility project.
The OCS grant created 145 jobs.
Jane Addams Resource Corporation in Chicago
Received a $250,000 grant from the Office of Community Services
that leveraged investment to support $1,100,000 in total development
costs for the 4422-36 North Ravenswood project and a $300,000 OCS grant
that leveraged investment to support $1,000,000 in total development
costs for the 4410 North Ravenswood project.
These OCS grants together created 55 jobs.
In order to build on such successful public and private investments
in distressed urban neighborhoods, Living Cities finds it to be
critically important to continue investment in job creation for low-
income people and to continue funding at the highest possible level for
programs that have a long history of success. As we have committed to
doubling our investment in the current decade, we urge the Subcommittee
to support a commensurate increase in funding for the OCS Discretionary
Grants Program. We also offer to work with the Subcommittee to explore
ways in which the OCS grants can foster further public/private
cooperation so as to leverage additional private investment by Living
Cities.
The work that has been done over the past decade to strengthen CDCs
has increased their capacity to participate in the OCS Discretionary
Grants Program. CDCs are providing the infrastructure to achieve
economic and social redevelopment of low-income neighborhoods. CDCs
take the risks as early investors, providing seed money and working
capital for community development projects that become catalysts for
further private investment. They encourage the participation of
residents in the redevelopment of their communities, prepare the
workforce for employment, develop local businesses and provide capital
and technical support to other businesses in their target areas. CDCs
secure funding for these activities from government, financial
institutions, corporations, foundations and other individual funders
Living Cities is supporting CDCs in these activities through our
investments in their work and by supporting research on urban markets,
including the collection of data on which business and investment
decisions are based. Based upon our experience, we see that even very
troubled neighborhoods can revive when community leaders, government,
and the private sector work together.
We are optimistic about the future of America's cities, given the
very real progress we see. In the past decade, the population of the
nation's largest 50 cities grew by nearly 10 percent. This was
accompanied by a rise in city incomes that outpaced the national
average (7 percent versus 4 percent, respectively) and an increase in
housing units, homeownership and mortgage lending. At the same time, in
certain urban areas concentrated poverty fell 24 percent in the last
decade and urban crime decreased. Inner cities have become hubs of
economic activity, with annual retail spending power of $85 billion or
the equivalent of 7 percent of U.S. retail spending. Business
investment has returned to some urban markets, bringing goods, services
and job opportunities. This progress bodes well for the economic
strength of cities, their regions, and the nation, economic strength
that we believe depends upon strong economies in urban neighborhoods.
PILOT CITIES INITIATIVE
Now in the second decade, Living Cities funders have challenged
themselves to do more. First, we have committed to investing an
additional $500,000,000 in the current decade. We also are building on
the successes of the first 10 years by creating a new investment model,
the Pilot Cities Initiative in Baltimore, Chicago, Miami and the Twin
Cities of Minneapolis and St. Paul. This initiative is creating new
ways for Living Cities investment partners and other funders to align
resources over a sustained period of time in order to have a greater
positive impact in distressed communities.
Through this new, more powerful model, funders will engage in
collaborative efforts to develop healthier neighborhoods by enhancing
the linkages between inner city neighborhoods and their residents and
the larger economies of their cities and their regions. This initiative
also will encourage CDCs to develop new relationships with philanthropy
and to expand the impact of economic development by working more
closely with other institutions that are serving the same
neighborhoods.
CONCLUSION
Despite the significant gains made in Living Cities communities
during the first decade and our ambitious plans for the next, we have
learned that future gains will be severely limited without additional
federal investment. We respectfully request that the Subcommittee
consider:
--Increasing the current funding level for the OCS Discretionary
Grants Program by an amount that Living Cities will match;
--Encouraging the use of grants to attract further private investment
and foster more public/private partnerships; and
--Allowing funding dollars to be used to collect data that document
the opportunities in the workforce and the purchasing power of
lower-income communities, with OCS serving as the lead federal
agency in gathering and making information accessible to people
who make business and investment decisions.
It will take a concentrated national effort, but we are determined
to see cities across the country reach and sustain healthy status in
our time, a level that is worthy of the richest society in the history
of humankind. With the support of private and public resources,
including the OCS Discretionary Grants Program, CDCs can continue their
significant work towards the goal of economic well-being, a goal that
includes job opportunities for low-income people.
Thank you for this opportunity to present our views regarding this
important program to the Subcommittee.
______
Prepared Statement of the American Public Transportation Association
INTRODUCTION
Mr. Chairman, thank you for the opportunity to submit a statement
for the record to the Subcommittee on Labor, Health and Human Services
and Education regarding the fiscal year 2005 Labor, Health and Human
Services and Education Appropriations Bill.
We submit our views to the Subcommittee to make the point that not
only can public transportation make a critical difference in how people
get to jobs, health care, training and other social services, but can
also provide significant cost efficiencies in the process. It is our
hope to work with committee staff in developing report language to
highlight this important issue.
ABOUT APTA
The American Public Transportation Association (APTA) is a
nonprofit international association of over 1,500 public and private
member organizations including transit systems and commuter rail
operators; planning, design construction and finance firms; product and
service providers; academic institutions; transit associations and
state departments of transportation. APTA members serve the public
interest by providing safe, efficient and economical transit services
and products. Over 90 percent of persons using public transportation in
the United States and Canada are served by APTA members.
THE EFFICIENCIES OF TRANSPORTATION COORDINATION ARE RECEIVING GREAT
ATTENTION FROM CONGRESS AND THE ADMINISTRATION
Mr. Chairman, the current budgetary climate and the emphasis it has
brought on doing more with limited resources provides a fitting context
for our focus on of transportation coordination. We believe that
relatively minor legislative changes based on simplicity and common
sense can provide for necessary consistencies across programs to make
transportation coordination work.
Recognizing the efficiencies and additional riders and resources
that are possible through improved coordination, APTA has long believed
in the potential of greater coordination between human service
providers and transportation providers. We have long seen the potential
for coordinated transportation to lower the costs of services to
taxpayers, enhance the scope and quality of service to customers, and
to avoid the duplicate purchase and use of equipment.
In May 2003, the House Committee on Transportation and
Infrastructure and the House Committee on Education and the Workforce
held a joint hearing to examine both the potential of and the obstacles
to coordination. One Member at that hearing noted that enhancing the
coordination of human services and transportation had been a topic of
interest to Congress since the 1970s. But, when all was said and done,
much more was said than done.
The joint House hearing heard from the General Accounting Office
(GAO) that there are some 62 federal programs that spend money on
transportation. The GAO also found that leadership on coordination was
lacking in that coordination seemed to be on everyone's list of things
to do but nowhere near the top of anyone's list. There was a Federal
Coordinating Council but it rarely met. The situation at the federal
level was replicated at the state level. Where states had leadership on
coordination through coordinating councils often created by the
governors, coordination was often impressive. Where that was not the
case, coordination was simply not happening. Like the tango, it takes
more than one state or federal agency to coordinate. Those who took
coordination seriously often found they were ``playing catch with
themselves.''
In our observation, Congress and the Administration are now taking
coordination seriously. Department of Transportation Secretary Norman
Mineta and Federal Transit Administrator Jennifer Dorn are reaching out
with some success to get more federal agencies on the dance floor. With
the launching of the Department of Transportation's ``United We Ride''
initiative, the Department of Health and Human Services, the Department
of Labor, the Department of Education, and other federal agencies are
beginning to recognize best practices at the state level and make
resources available to enhance state performance. President Bush, to
his great credit, has issued an Executive Order calling on federal
agencies to assess their roles in coordination and report back to the
White House in 1 year on progress they are making to enhance the
coordination of transportation programs.
CONGRESS IS ADDRESSING TRANSPORTATION COORDINATION ON SEVERAL FRONTS
Several pending bills contain language that would bolster the
coordination of federal transportation programs. APTA is supportive of
these efforts.
Pending bills to reauthorize the Federal Transportation Equity Act
for the 21st Century (TEA 21) contain numerous provisions that will
enhance transportation coordination, including allowing funding from
human service programs to be used as a match for FTA programs so long
as programs are coordinated, broadening the eligibility guidelines for
Job Access and Reverse Commute (JARC) funding, recognizing Mobility
Management as an eligible program expense, and requiring local
certification plans for the New Freedom, JARC, and Elderly and Disabled
programs.
As part of the pending welfare reform legislation, the Senate
Finance Committee has approved an amendment supported by APTA calling
upon states that use Temporary Assistance for Needy Families (TANF)
funds for transportation purposes to certify that they have consulted
with transportation agencies in the provision of such services. It
seems to be a simple common sense matter, but it often doesn't happen.
Such certification will make a requirement of what is now often an
afterthought. The House-passed welfare reform bill (H.R. 4) contains an
important provision in its TANF program that would treat transportation
subsidies as ``nonassistance'' for purposes of the Act and therefore
need not be discontinued when a person exhausts their eligibility for
public assistance. Like childcare support, transportation aid is
essential to those who not only want to get a job, but also those
striving to retain their job.
Similarly, there are provisions in the Senate's version of the
Workforce Investment Act that call on state and local workforce
planners to account for how people are to get to training and available
jobs. It makes as much sense to coordinate training with available
transportation as it does to link training to available employment.
Along with childcare, the ability to get to a job efficiently is often
the factor that determines whether a person can get and retain
employment.
It is APTA's hope that significant progress can be made in the next
year as both Congress and the Executive Branch focus attention on
replacing old habits with new habits.
PUBLIC TRANSPORTATION PROVIDES AFFORDABLE AND EFFICIENT ACCESS TO
HEALTH CARE
Following the old adage, ``follow the money,'' we note that the GAO
identified a major source of transportation spending in the Medicaid
program. Close to $1 billion is spent on transportation to assist
Medicaid clients. APTA members in Connecticut and Florida have had some
success offering mainline transit service to those for whom it is
appropriate through a Medicaid Pass Program. Medicaid clients see their
transportation options enhanced at the same time the Medicaid program
sees its costs lowered. Transit operators experience an increase in
ridership while being reimbursed by the Medicaid program. Such programs
can be a win/win/win situation for those who need services, those who
pay for them, and those who provide the service.
Public transportation has already demonstrated its ability to
effectively provide non-emergency transportation to health care
services when given a chance. In 1997, the Healthcare Financing
Administration estimated it was losing $1.2 billion annually in non-
emergency medical transportation subsequently states began to
coordinate services with local transit systems and by 2000 20 percent
of the nation's Medicaid rides were on public transit.
While lack of coordination between providers of transportation
assistance programs for the elderly and disabled and public
transportation systems is not a new problem, the need for these
services will continue to grow. According to a recent FTA study, 32
million senior citizens rely on transit as their driving ability
decreases; 27 million Americans with disabilities depend on transit to
maintain their independence; and 37 million people who live below the
poverty line and cannot afford to drive rely on transit to get to work.
The population of elderly transit users is expected to rise, growing
nearly four times faster than the general population between 2010 and
2030; yet according to the AARP, more elderly people now live in
suburban settings that lack transit options than ever before.
Public transportation has worked hard to improve its service.
Between 1990 and 1999, the percentage of wheelchair accessible buses
has increased dramatically. Systems continue to update their vehicles,
including trains and buses, to ensure that individuals with
disabilities can use their service. With access available to
populations served by HHS and other social programs across the country,
public transportation is clearly in a position to help these people and
save taxpayer dollars right now.
PUBLIC TRANSPORTATION DELIVERS PEOPLE FROM WELFARE TO WORK
Similar to its success in helping the elderly and disabled, public
transportation is already at work helping the population of low-income
workers and job seekers such as TANF clients by providing low-cost,
efficient transportation services.
Many welfare recipients do not own cars and must rely on public
transportation to get to work. And while most welfare recipients live
in central cities, most newly created jobs are in the suburbs. Public
transportation has been successful in many cases in providing
transportation options to these job seekers, especially under the JARC
program, but barriers remain. For instance, Fort Worth's transportation
authority, The T, has noted that it has difficulty coordinating various
sources of funding to provide transportation service that gets workers
from the central city to the suburbs because local service providers
are required to track separate data from both the Department of Labor
and the Department of Housing and Urban Development.
CONCLUSION
Mr. Chairman, the public transportation community stands ready to
provide a cost efficient, easy-to-use and effective solution to the
increased demand for transportation options for communities served by
federal programs such as TANF. The U.S. Department of Transportation is
already required to coordinate with HHS, but it needs to improve
coordination with HHS as well as with other agencies at all levels of
government. Many states and local governments are excelling at this
process. Millions of additional federal dollars could be saved by
requiring all states to follow their lead.
Enabling effective coordination between all federal agencies and
the DOT requires statutory changes to provide the Coordinating Council
with authority to require recipients of federal funds at all levels to
work together. Taking advantage of the TEA 21 and TANF reauthorizations
to require state and local governments that receive TANF and JARC funds
to coordinate their services would be an excellent first step. This
will put the experience and resources of transit to use to effectively
serve our disadvantaged populations.
Mr. Chairman and Members of the Committees, we urge you to take
public transportation service and the cost efficiencies it provides
into consideration as you mark up your fiscal year 2005 appropriations
bill. We would be pleased to work with your staff in developing report
language in that regard.
In closing, APTA would like to urge this Subcommittee to remain
vigilant as you monitor the progress of executive agencies and the
Coordinating Council in the next year. Progress is being made but there
is much more to do.
Thank you.
______
Prepared Statement of the Coalition of Northeastern Governors
The Coalition of Northeastern Governors (CONEG) is pleased to
provide this testimony for the record to the Senate Subcommittee on
Labor, Health and Human Services, and Education regarding fiscal year
2005 appropriations for the Low Income Home Energy Assistance Program
(LIHEAP). The Governors appreciate the Subcommittee's consistent
support for the LIHEAP program, and we recognize the difficult
decisions facing the Subcommittee in this time of severe fiscal
constraints. However, in light of sharply higher home energy prices, we
request the Subcommittee to provide $3 billion for LIHEAP in regular
fiscal year 2005 funding and $3 billion in advance appropriations for
fiscal year 2006.
LIHEAP is a vital tool in making home energy more affordable for
almost 5 million of the nation's very low-income households--the
elderly and disabled on fixed incomes and families with young children.
Recent survey data compiled by the National Energy Assistance
Directors' Association (NEADA) provide a glimpse of the difficult
choices made by low-income households and the strong, ongoing need for
LIHEAP assistance. The percentage of income spent on total home energy
by these low-income households can be four times higher than average
households. For many of these households, annual income is simply not
sufficient to pay high winter heating bills, even in periods of
economic growth. Even after taking constructive actions to reduce their
home energy use, too many low-income residents are forced to make
dangerous choices between heating their homes, paying the full rent or
mortgage, seeking medical attention, or purchasing food or vital
medications. The NEADA survey found that an estimated 38 percent of
LIHEAP recipients went without medical or dental care; approximately 28
percent did not make a rent or mortgage obligation; 30 percent did not
fill a prescription or take the full dosage; and 21 percent became sick
because the home was too cold.
The rise in winter heating fuel prices hits these vulnerable
citizens especially hard. The Northeast is heavily dependent on
deliverable home heating fuels such as home heating oil, kerosene, and
propane. Price volatility in these fuels adversely affects the low-
income households who, without the disposable income to purchase fuels
off-season, typically enter the market when both the demand for and
price of fuels are high.
Rapidly rising energy prices, the very cold winter conditions in
many parts of the country, and the continued high unemployment among
low-wage workers continue to put heightened demand on the states'
already stretched LIHEAP programs. In fiscal year 2004, states expect
to serve an estimated 4.8 million low-income households with LIHEAP
assistance, an increase of 6 percent over the 2002-2003 period.
However, the number of low-income households eligible for LIHEAP
assistance increased by a similar 6 percent--to approximately 34.6
million households. In short, in spite of the welcomed increase in
LIHEAP funding, only a fraction--approximately 15 percent of eligible
households--continue to be served at current LIHEAP funding.
An increase in the regular LIHEAP appropriation to $3 billion for
fiscal years 2005 and 2006 will enable states across the nation to
reach more of those vulnerable citizens in need of assistance and more
fully implement cost-effective measures to meet their continuing energy
needs. Today, most winter heating programs have exhausted their program
resources at the end of the heating season, leaving little or no
resources for cooling programs this summer; or they have limited
ability to assist families who, in arrears on heating bills, face the
prospect of having their home heating source cut off. In addition,
without funds to carryforward to the new heating season, state LIHEAP
programs lack the capability to undertake the ``pre-buy'' programs that
help stabilize heating fuel prices for low-income households and expand
the reach of limited program funds. An increased federal appropriation,
and advance funding, would allow states to manage the program resources
in a manner to better take advantage of market opportunities.
Enactment of advance funding is vital to the states' program
planning activities for the coming heating season. In the Northeast,
where the heating season begins in early October, states generally
spend up to 70 percent of the LIHEAP funds during the first two
quarters of the fiscal year. Therefore, states must begin to plan and
do program outreach in the spring and summer if they are to begin their
LIHEAP program as soon as the new fiscal year starts. Advance funding
helps ensure that states have the necessary funds to open their
programs and provide timely assistance to low-income families who lack
the financial resources to bear the initial costs of deliverable home
heating fuels.
The current uncertainty of world energy markets underscores the
importance of states being able to prepare for the potential of
volatile energy prices. These preparedness activities, while critical,
cannot fully shield our lowest-income citizens from the impacts of
higher heating fuel prices. Your support for fiscal year 2005 LIHEAP
appropriations at the $3 billion level and the enactment of advance
fiscal year 2006 appropriations is urgently needed to enable our states
to help mitigate the potential life-threatening emergencies and
economic hardship that confront the region's most vulnerable citizens.
We thank the Subcommittee for this opportunity to share the views
of the Coalition of Northeastern Governors, and we stand ready to
provide you with any additional information on the importance of the
Low Income Home Energy Assistance Program to the Northeast.
______
Prepared Statement of the American Public Power Association
The American Public Power Association (APPA) is the national
service organization representing the interests of over 2,000 municipal
and other state and locally owned utilities in 49 of the 50 states (all
but Hawaii). Collectively, public power utilities deliver electricity
to one of every seven electric consumers (approximately 40 million
people), serving some of the nation's largest cities. However, the vast
majority of APPA's members serve communities with populations of 10,000
people or less.
We appreciate the opportunity to submit this statement supporting
funding for the Low-Income Home Energy Production Assistance Program
(LIHEAP).
APPA has consistently supported an increase in the authorization
level for LIHEAP to $3.4 billion annually--an increase that was
embodied in the stalled Energy Policy Act and has also been advanced
more recently in the Senate's version of the Poverty Prevention and
Reduction Act, a bill that has not yet been considered in the House. In
the absence of final action on an increased authorization level for the
program, the Administration's request of $2 billion for fiscal year
2005 ($1.8 billion in state block grant funding and $200 million in
emergency funding) is a good start. However, APPA believes that the
Subcommittee should consider appropriating the $3.4 billion necessary
in fiscal year 2005 to more fully meet the energy needs of low-income
households.
APPA is proud of the commitment that its members have made to their
low-income customers. Many public power systems have low-income energy
assistance programs based on community resources and needs. Our members
realize the importance of having in place a well-designed low-income
customer assistance program combined with energy efficiency and
weatherization programs in order to help consumers minimize their
energy bills and lower their requirements for assistance. While highly
successful, these local initiatives must be coupled with a strong
LIHEAP program to meet the growing needs of low-income customers. In
the last several years, volatile home-heating oil and natural gas
prices, severe winters, high utility bills as a result of the western
electricity crisis, and the effects of the economic downturn have all
contributed to an increased reliance on LIHEAP funds.
Also when considering LIHEAP appropriations this year, we encourage
the Subcommittee to provide advanced funding for the program so that
shortfalls do not occur in the winter months during the transition from
one fiscal year to another. LIHEAP is one of the outstanding examples
of a state-operated program with minimal requirements imposed by the
federal government. Advanced funding for LIHEAP is critical to enabling
states to optimally administer the program.
Thank you again for this opportunity to relay our support for
increased LIHEAP funding for fiscal year 2005. We look forward to a
favorable outcome.
______
Prepared Statement of the Meals On Wheels Association of America
Mr. Chairman and Members of the Subcommittee, we are Enid A. Borden
and Margaret B. Ingraham, Chief Executive Officer and Director of
Policy and Legislation, respectively, of The Meals On Wheels
Association of America (MOWAA). The Association represents local
community-based meal programs from every state that provide congregate
and home-delivered meals and other nutrition services to older persons
in need. It is on behalf of MOWAA, its member programs, and the
literally hundreds of thousands of frail, elderly and at-risk
individuals that they serve that we present this testimony.
As part of the appropriations process in which this subcommittee
engages every year, you doubtless hear from hundreds, probably
thousands of individuals and organizations representing programs funded
through the enormous bill under your purview. Each comes to advocate
for a specific project or program and to make the case as to why that
program merits a particular level of federal financial support in the
next fiscal year. In that regard, MOWAA is no different from the others
from whom you have heard. But in other ways--significant ones that we
will enumerate briefly--MOWAA, or rather the senior meal programs that
are our members--are significantly different.
Please allow us the opportunity to put our request in an historical
and human perspective. In 1972 when it reauthorized the Older Americans
Act, Congress included senior nutrition programs among the services
funded under the Act. Today, ``Meals On Wheels,'' as those programs
have come to be popularly called, are perhaps the most widely
recognized and universally lauded of Older Americans Act programs. It
should come as no surprise to you that we also believe they are the
most important. Why? The answer is simple. Because food is fundamental
to life and health and psychological and emotional well-being. There is
no arguing that fact. All of us eat regularly, generally 21 meals per
week and we even may sneak a snack here or there when we get hungry.
But many of America's most vulnerable citizens, the frail and at-risk
elderly, have no ability to shop for or to prepare meals for
themselves. For them, home-delivered meal programs are a virtual
lifeline. In some cases, they are the only source of nutritious food
that a senior has; and even then, most programs have the resources to
provide only five meals each week.
Last year, according to the Administration on Aging over 253
million meals were served with Older Americans Act funds. That is
impressive indeed. But the sad reality on the underside of that success
is that hundreds of thousands of equally needy seniors were not served.
A conservative estimate is that 4 out of every 10 home-delivered meal
programs have waiting lists. And currently, the old-old age group
(defined as 85 and older) is the fastest growing cohort in the U.S.
population. So, simply stated, if appropriations levels are not
increased, and increased substantially, the unspeakable will occur.
That is, even larger numbers or frailer individuals will be going
hungry. Mr. Chairman and members of the subcommittee, we believe that
is unacceptable in this the wealthiest nation on the planet.
Earlier we mentioned historical context. Let me return to that. In
fiscal year 1992, 20 years after the establishment of OAA nutrition
programs, the federal financial commitment was just over $607 million.
(That figure represents the sum of Title III C-1, III C-2 and NSIP
(then called USDA/NPE)). For fiscal year 2004, the President has
requested $719 million. Yes, that is an increase; but it is a grossly
inadequate one. For during the intervening years since 1992, other
important factors have changed. First, there is inflation. Then there
is the population shift, which has dramatically increased the number of
individuals needing assistance with nutrition services. In 1992 there
were 42.7 million individuals age 60 and older in the United States,
and approximately 3.3 million of those were 85+. In this year (2004)
the number of those 85+ is over 4.7 million. That, by any standard, is
astounding growth. And it is growth that has gone largely
uncompensated. Here is what we mean by that.
We asked one of this country's most distinguished actuaries to look
at these numbers, to look at population growth and inflation (by
applying the annual CPI-U) and then to produce an ``equivalent''
appropriation level. That is, we asked him to calculate what the
federal commitment to each elder was in fiscal year 1992 and then to
determine what funding levels these senior meal programs should have
received in fiscal year 2004 to ensure parity with 1992. Why parity?
Because we know that you agree that today's elders are just as
important a part of our society today as they were 12 years ago.
Today's elders--your parents and grandparents and perhaps even siblings
and neighbors, certainly your constituents--are as deserving as those
who came before them of receiving senior nutrition program services
when they can no longer provide meals for themselves. Had you provided
parity in 2004 with 1992, based on the changes in the CPI-U and the 85+
population alone, the funding level would have been approximately
$1.158 billion, an almost 61 percent increase over the $719 million
being requested by the Administration for the next fiscal year. This
year's request, in fact, is less than the 1992 enacted level for
Nutrition Services Incentive Program (NSIP, formerly USDA); it is less
than the 2002 enacted level for Title III C-1; and it is the same level
as the fiscal year 2003 enacted level for Title III C-2. In other
words, overall the request is much less than adequate for us to keep
faith with the older population that depends on local community-based
meal programs in every State in this great country. We are not so
unrealistic as to believe that we can achieve parity in 1 year,
although we do believe our case has merit. Mr. Chairman and members of
the subcommittee, the Meals On Wheels Association of America does
urgently and sincerely request that you increase funding for senior
meal programs by no less than 10 percent for each line item over last
year's levels, to approximately $786 million combined.
The year 2005 will mark the 40th Anniversary of the Older Americans
Act, and we can think of no more fitting way to recognize the
invaluable contribution that OAA programs have made in the lives of
older Americans and to demonstrate Congress' continued commitment to
elders than by adopting funding levels that will help local programs
serve those in need.
Before we close we do want to make one more point, that is often
overlooked when it comes to senior nutrition programs. These senior
meal programs that receive funding through the Older Americans Act
exemplify how effectively public-private partnerships can serve
citizens in need. For that is what these programs are: public-private
partnerships that reflect the unique needs and characteristics of the
communities in which they operate and that rely on a number of funding
sources. Federal dollars are only a portion of the funds on which these
programs rely in order to operate. But they are a critical part, for
they enable programs to leverage money from a variety of other sources,
such as States and local governments, foundations, corporations and
individuals. In the home-delivered program, for example, each $1 in
federal funds leverages $3.35 from other sources. So even a modest
increase in funding of 10 percent could assist in a major way in
meeting unmet need.
As you consider our request, you may want to keep in mind in whose
behalf MOWAA is making it. Each and every one of these ``frail,
homebound individuals'' is unique, just as you and I, so it is
impossible to give you a description that covers them all. But here is
a simple profile: the average Meals On Wheels recipient is an elderly
woman in her very late seventies or eighties; she is more than twice as
likely as her contemporaries to live alone, apart from family and
friends. She is likely to be functionally impaired (have trouble
walking, for example) and have three or more diagnosed chronic health
conditions. In addition, she probably has an income below 200 percent
of poverty. Whatever the reason, she cannot shop, cook, or prepare
meals for herself. In other words, she relies on Meals On Wheels
programs to ensure she gets proper nutrition. And without that, she
would probably be at risk of being forced to move out of her home
prematurely into an institutional care facility. These folks reside in
cities and suburbs and rural communities across America.
Thank you for the opportunity to bring these issues to your
attention. Again, on behalf of MOWAA, local meal programs across
America, and, most important, the at-risk and frail seniors that turn
to them for meals and other nutrition services, we ask that you give
serious consideration to renewing the commitment of your colleagues in
previous Congresses and to increasing funding to a level that moves
resolutely toward a level that is commensurate with that of a decade
ago. A 10 percent increase for fiscal year 2005 is a good first step.
______
Prepared Statement of the National Association of Nutrition and Aging
Services Programs
Chairman Specter and Ranking Member Harkin: The National
Association of Nutrition and Aging Services Programs (NANASP), a
professional membership organization representing the interests of
members at all levels of the aging network dedicated to providing
quality nutrition and other direct services for older Americans,
recommends an increase of 10 percent for the three Older Americans Act
(OAA) nutrition programs as part of the fiscal year 2005 appropriations
bill for the Department of Health and Human Services under your
jurisdiction.
This position is taken in concert with the position of the 50-
member Leadership Council of Aging Organizations (LCAO) of which NANASP
is a member. LCAO supports a 10 percent across the board increase for
all Older Americans Act programs.
NANASP's focus is the congregate and home delivered meals programs
and the Nutrition Services Incentive Program, since our more than 800
members nationally work on the front lines every day providing seniors
with nutrition and related services.
The President's budget called for a slight increase in funding of
$4.35 million for the three OAA nutrition programs. However, the amount
of the increase is only 0.6 percent of the total funding and does not
even come close to inflation, estimated at 3 percent over the past
fiscal year. In fact, the nutrition programs are entering a second
decade of a funding deficit which is eroding the effectiveness of the
programs for those being served. Whereas inflation has increased by
44.45 percent since 1990, funding for the OAA has only increased by
24.4 percent. Also since 1990, funding has only increased 9.8 percent
for the congregate nutrition program.
Administration data for fiscal year 2002 indicates that while the
OAA nutrition programs are serving more individuals, they are serving
fewer meals to these individuals. This defeats a main benefit of the
program which is to provide eligible seniors with a minimum of one-
third of their required daily dietary allowance. The reduction in meals
can present genuine hardships to the seniors who are served, especially
those in the greatest economic need who are to be targeted for service
under the Older Americans Act.
Furthermore, data provided by AARP forecasts that nearly 5 million
meals will be cut from both the congregate and home delivered meals
programs if no adjustments are made to the President's fiscal year 2005
budget. The question to ask is how do these meals get replaced?
A modest 10 percent increase in the nutrition programs constitutes
about $71 million. This will help these programs to maintain services
to their existing seniors thus avoiding the need for new or expanded
waiting lists. Older adults waiting for basic services often wind up on
nursing homes and are at risk for losing their homes and independence.
The Older Americans Act nutrition programs are a proven success
story with more than 30 years of serving seniors in your state and
throughout the country. Funds provided for these programs are
investments in promoting and maintaining the independence of seniors.
The Older Americans Act nutrition programs are more than just a meal.
These are preventive programs: they help avert malnutrition and control
chronic conditions such as diabetes, and through socialization and
other individual contact help keep seniors from becoming isolated.
Programs with the longevity and proven track record of the elderly
nutrition programs need to be supported with adequate, but fiscally
reasonable funding levels. That is what we advocate today.
NANASP encourages you and all members of the Subcommittee to visit
an elderly nutrition program in your state either during the upcoming
spring recess or during May, which is Older Americans Month. NANASP is
happy to provide you with the names and addresses of programs from your
state. See firsthand how these programs are great value propositions.
They provide value through their services to seniors and they provide
value to the taxpayer dollar by delivering a core service and more in
an efficient and localized manner in a home or community setting where
older adults want to stay.
______
NATIONAL INSTITUTES OF HEALTH
Prepared Statement of the American Institute for Stuttering
Mr. Chairman and members of the Subcommittee, I am Catherine S.
Montgomery, Executive Director of the American Institute for Stuttering
(AIS). AIS was founded in 1997 in response to the need for a
comprehensive treatment and training facility for stuttering in the
United States. It is the only nonprofit facility in this country that
offers both intensive and non-intensive treatment options for people of
all ages while also providing clinical training to both new and
established speech-language pathologists.
Stuttering is one of the few disorders that people still laugh at.
The disorder wreaks havoc in one's life that few understand, and much
of it is silent suffering, below the surface. Healthy intelligent
children who stutter are placed in ``special classes'' and labeled
eccentric, mentally ill and emotionally disturbed. In all honesty, many
of these children have IQs 10 to 14 points higher than the general
population. Public education is needed to rectify a long history of
neglect and misunderstanding.
Developmental stuttering typically begins between the ages of 3 and
8 years of age. Some of the most important work now being done in
stuttering is in early intervention treatment. It is very cost
effective, yet many do not receive treatment due to a lack of
clinicians trained specifically in speech-language pathology. There is
also a dire lack of public awareness about the necessity for earlier
diagnosis and treatment possibilities.
Despite the fact that stuttering affects approximately 3 million
people in the United States, it remains almost imperceptible as a
public health issue. It should be noted that suicide among teenagers
who stutter is 3 to 4 times higher than the general population. AIS is
launching ``Let's Talk,'' a national public education and fundraising
campaign to create a major cultural shift in public attitudes about
stuttering.
``Let's Talk'' targets six program objectives to better serve the
stuttering community:
1. Public Education
2. Research
3. Clinical Treatment
4. Treatment Scholarships
5. Clinical Training
6. Advocacy
The American Institute for Stuttering has embarked upon a new
professional relationship with New York Medical College and Ben Watson,
Ph.D. Dr. Watson is among the few preeminent researchers in the United
States whose focus is on learning more about the neurological roots of
stuttering. He is now conducting two new exciting studies that will
help move us along in our search for the cause of stuttering.
We know a great deal about the speech and language abilities and
brain function of adults who stutter and we are learning a great deal
about the speech and language abilities of young children at the onset
of stuttering. Some people who stutter as children do not stutter as
adults. The reason for that is not known but Dr. Watson is exploring
this question through investigation of speech, language and brain
function in young children who do and who do not stutter.
Previous studies show that brain activity in some people who
stutter differs from that seen in nonstutterers. We now need to find
out if, and how these differences in brain activity are related to
stuttering. To answer these questions, scientists from New York Medical
College and the Harlem Hospital Center are studying brain activity in
persons who stutter during the production of both stuttered and fluent
speech. This study may clarify the relationship between changes in
brain activity and fluency breakdown.
The disorder of stuttering has been one of the most seriously
misunderstood of human handicapping conditions. Approximately 1 percent
of the population of the United States, some 3 million Americans,
suffer this inability to speak freely and try to cope with the daily
agonizing struggle and ridicule that accompanies it. The American
Institute for Stuttering is dedicated to filling the serious void in
the availability of quality treatment and training.
The American Institute for Stuttering asks that you support a 10
percent increase in the budget of the National Institutes of Health in
order to maintain the momentum that has been built up over the past
half-decade. Further, we would ask that additional funds be made
available for the National Institute of Deafness and Other
Communications Disorders (NIDCD) to support stuttering research. There
is currently about $3 million of federal funding dedicated to
stuttering research. This works out to about $1 per person afflicted
with this disorder. Moreover, Mr. Chairman, we respectfully request
that the committee provide NIDCD with resources to support a consensus
conference on stuttering. Such a conference will bring together the
leading scientists in the field to assess the current state of the
science and will hopefully identify future research opportunities.
Thank you for this occasion to present this testimony.
______
Prepared Statement of the National Primate Research Centers
The Directors of the National Primate Research Centers (NPRCs)
respectfully submit this written testimony for the record of the U.S.
Senate Appropriations Subcommittee on Labor, Health and Human Services,
and Education. The NPRCs appreciate the commitment that the members of
this Subcommittee have made to biomedical research through strong
support for the National Institutes of Health (NIH). Given your
leadership on this issue, the NPRCs urge Congress to direct resources
to vital biomedical research infrastructure in order to ensure that the
success of the federal investment in NIH will not be compromised as a
result of deficient research resources.
The NPRCs are a national network of eight primate research centers
supported by the NIH National Center for Research Resources (NCRR). The
centers comprise the National Primate Research Program (NPRP), which
was developed in 1960 in response to recommendations provided to
Congress by the National Heart Institute Advisory Council. This program
seeks to address human health problems through scientific research
using the animal models that most closely resemble humans in their
genetics, physiology, and disease processes--primates. The NPRCs were
developed specifically as resources to advance primate research by
providing specialized research facilities and technologies as well as
unique living environments for primates. NPRCs support research that is
sponsored by nearly every institute of NIH. For example, NPRCs conduct
research to help understand and treat diseases such as heart disease,
cancer, diabetes, Alzheimer's, Parkinson's, and AIDS. They also conduct
research on emerging infectious disease and on many aspects of
biodefense. Each NPRC makes its facilities available to investigators
from around the country. In fact, the NPRCs support more than 1,500 NIH
funded investigators each year. This collaborative research environment
allows scientists to combine their individual expertises beyond the
scope of established disciplinary research projects.
Research involving animals is a vital element in achieving this
goal of continued medical progress for human health. The specific
availability of information in the primate genome, which is quite
similar to the human genome, makes primates essential in studies that
require an integrated understanding of a whole biological system.
Primate studies allow scientists to answer fundamental questions
regarding both specific diseases and normal physiological processes
that cannot be addressed directly in humans or effectively in more
evolutionarily distant species such as rodents. Recent reports suggest
that extensive analysis of genome structure and function in nonhuman
primates could make immediate and significant contributions to the
overall mission of NIH by accelerating progress in understanding many
human diseases.
In the 1950's, primate research produced the first vaccine for one
of the world's worst childhood killers, the Polio virus, reducing the
number of cases in the United States from 58,000 to one or two per
year. Primates have also served as the best model for various types of
HIV research, and their availability for use has resulted in at least
14 licensed anti-viral drugs for treatment of HIV infection. Primate
models will continue to be necessary to defend the world against future
and assuredly occurring scourges of which we have already had hints,
like SARS and West Nile Virus. In addition to these deadly viral
epidemics, primate research has enabled the discovery of better
treatments and therapies for diseases such as diabetes, heart disease,
high blood pressure, kidney disease, depression, and other psychiatric
illnesses. Treatments for stroke and cataracts, and the advancement of
prenatal and postnatal care have also resulted from primate research.
Furthermore, in addition to the potential to provide answers for long-
standing research questions, primate research provides an unparalleled
opportunity to address more recently defined research priorities such
as those relating to the threat of bioterrorism.
Mr. Chairman, as you and your Subcommittee work to define your
priorities for the year and set goals for the future, NPRCs ask that
you continue the commitment of support for NIH and its mission by
providing the highest funding level possible in the NIH appropriations
bill. An increase would enable researchers to continue vital merit
based studies on devastating diseases and disabilities, as well as
address new and emerging national health priorities. The NPRCs believe
this increase is justified by both the health needs and research
capabilities of the nation. The President's budget asks for a 2.6
percent NIH increase; however, NPRCs, the Ad Hoc Group for Medical
Research Funding, and other leaders of the research community hope for
more. Funding for NIH has helped to expand our nation's capabilities in
biomedical research, and develop new treatments and cures for many
diseases, but many unsolved human health mysteries still remain.
Medical research is a long-term process and in order to continue to
meet the evolving challenges of improving human health we must not let
our commitment wane. It is therefore essential to sustain the momentum
of NIH-funded research so that it continues to meet the goal of
improving the health of all Americans.
NIH relies on the NPRCs to provide centralized, professional care,
management, and research conducted with primates. Consequently, the
NPRCs, which are funded by annual NIH P51 base grants, have become an
indispensable national scientific resource. Increased base grant funds
from NIH/NCRR to meet the current and projected NPRC operational and
modernization costs are critical to the success of NPRCs and their
programs. NPRCs directors ask that you direct NIH to adopt and fund the
NPRP Five Year Federal Advancement Initiative, developed by the NPRCs
directors, for the NPRP, which addresses necessary upgrades and program
capacity expansions. The total anticipated cost of the NPRP Federal
Advancement Initiative would be $100 million over the current funding
level for the NPRP P51 base grant during the 5 year period of fiscal
years 2005-2009. Over 5 years, the NPRP Federal Advancement Initiative
aims to increase the following by 20 percent : (1) the nationwide
availability of primates; (2) the quality and capacity of primate
housing and breeding facilities, as well as the availability of related
state-of-the-art diagnostic and clinical support equipment at NPRCs;
and (3) the number of personnel trained in primate care and management
at the NPRCs. The NPRCs urge Congress to direct NIH to adopt and fund
the Federal Advancement Initiative, beginning with a $36 million
increase in funding for the P51 base grant in fiscal year 2005. The
NPRCs also ask that Congress directs NIH to engage in a meaningful
planning process to invest in the long-term needs of the NPRCs.
For 2 consecutive years, language strongly in support of NPRCs has
appeared in the report accompanying the Labor/HHS/Education
Appropriations bills. The reports recognize the importance of the NPRCs
as well as centers' demanding resource requirements. The fiscal year
2004 House report directs NCRR to periodically assess NPRCs needs, and
to increase the P51 base grant funds for the centers. The report also
directs NCRR to submit the first of the periodic assessments along with
the fiscal year 2005 budget request. As you know, the Senate issued
report language stating that NCRR is expected to fully commit to the
Five Year Federal Advancement Initiative. Thus far, while NPRCs have
seen modest increases in base grant funds, the initiative has yet to be
applied and funded by NCRR.
Biomedical researchers across the nation are experiencing shortages
in the availability of primates for essential research. NPRCs, the
federally funded primate resource, have found it increasingly difficult
to provide sufficient numbers of primates for ambitious and high
priority federal research projects on cancer, AIDS, and biodefense. In
many cases, NIH funded scientists must wait a year or more to begin
their research due to the limited availability of primates and/or
space. These critical shortages can only be addressed by expanding
existing breeding colonies and developing bridging programs to
effectively use under-utilized species of primates in research.
Ultimately, this would reduce the wait period for the use of primates,
expediting the start of critical research projects. Presently, the
budget of each NPRC falls below the amount required to maintain crucial
services at existing levels. By adopting and funding the Federal
Advancement Initiative, not only will the centers be able to sustain
existing programs, but they will have the ability to build much needed
programs that will better serve the nation's federally funded primate
researchers.
Accommodating and properly caring for increasing numbers of
primates also requires additional funding to modernize and expand
primate housing and research facilities. As primate populations grow
and primate resources increase, proper infrastructure will be necessary
to house and care for these additional animals. Under the Federal
Advancement Initiative, additional P51 base grant funds will also be
invested in repairs, renovation, and construction of research
facilities, as well as the purchase of modern laboratory equipment.
These are essential upgrades needed to ensure that the federally funded
research community can translate new discoveries into treatments and
cures. Increased funding under the P51 will give the NPRCs the ability
to develop the state-of-the-art capabilities and facilities necessary
to keep pace with the expanded NIH research agenda.
Since nonhuman primates represent the most sophisticated and
relevant animal models for many areas of biomedical research, there is
a heightened need to use primate models prior to human clinical trials,
as well as a heightened responsibility to properly care for and manage
these animals. Thus, the Federal Advancement Initiative proposes to use
increased P51 base grant funding to ensure that adequate numbers of
experts are trained in laboratory animal medicine and research. Each
NPRC requires a highly trained and experienced primate management team
comprised of behavioral specialists, veterinarians, and primate
research experts. As the number of primates at the NPRCs grows,
proportional expansion of the primate management teams is essential to
maintain primate health and research success.
The NPRCs provide scientists across the nation with unmatched
access to these crucial research models in the process of making
significant medical discoveries and translating these discoveries into
effective therapies and treatments. This is an essential and valuable
centralized service for researchers who cannot afford to use and
maintain scarce and expensive primates solely for individual research
projects. For every dollar provided to the NPRCs, more than $10 in NIH
research is leveraged, which is equivalent to approximately $600
million in NIH research that could not otherwise be carried out.
With this in mind, the NPRCs express their sincere hope that the
nation will continue to sustain the healthy development of its
biomedical research program and that this Subcommittee will continue
its support and leadership on behalf of NIH and its research partners
across the nation.
Mr. Chairman, as you and your Subcommittee work to define your
priorities for the year and set goals for the future, the NPRCs
directors ask that you direct NIH to adopt and fund the NPRP Five Year
Federal Advancement Initiative. Investing in and enriching the NPRCs
will help to expand our nation's capabilities in biomedical research,
and enable the development of new treatments and cures for many
diseases. NIH adoption of the NPRP Federal Advancement Initiative will
allow NPRCs, as well as NIH, to continue to meet and advance the goal
of improving the health of all Americans.
Thank you for the opportunity to submit this written testimony and
for your attention to the recommendations of the NPRCs concerning
funding for NIH in fiscal year 2005 and implementation of the NPRCs
Five Year Federal Advancement Initiative.
______
Prepared Statement of the FacioScapuloHumeral Muscular Dystrophy
Society
Mr. Chairman, it is a great pleasure to submit this testimony to
you today.
My name is Carol Anne Perez, of Lexington, Massachusetts, and I am
testifying as Executive Director of the FacioScapuloHumeral Muscular
Dystrophy Society (FSH Society, Inc.) and as an individual who has
lived with the devastating facioscapulohumeral muscular dystrophy
(FSHD) disorder for nearly 70 years.
Facioscapulohumeral muscular dystrophy (FSHD) is the third most
prevalent form of muscle disease. FSHD is a neuromuscular disorder that
is transmitted genetically to 120,000 people. Conservatively, it
affects 14,000 persons in the United States. For men, women, and
children the major consequence of inheriting FSHD is progressive and
severe loss of all skeletal muscles gradually bringing weakness and
reduced mobility. The usual pattern is of initial noticeable weakness
of facial, scapular and upper arm muscles and subsequent weaknesses of
other skeletal muscles. Retinal and cochlear disease, as well as mental
retardation, can be associated with FSHD. Many with FSHD are severely
physically disabled and spend the last 30 years of their lives in a
wheelchair. The toll and cost of FSHD physically, emotionally and
financially are enormous. FSHD is a life long disease that has an
enormous cost-of-disease burden and is a life sentence for the innocent
patient and involved persons and their children and grandchildren as
well. As a human services professional, wife, mother, and grandmother I
am now in wheelchair due to the effects of FSHD.
In accordance with its primary purpose of serving the FSHD
community, both in the United States and abroad, the FSH Society,
through outreach at home and international networking, has brought
together more than 3,000 FSHD-affected families committed to working
cooperatively. From the moment of their introduction into the FSH
Society, these families, and, in many instances, their friends are
bonded with their fellow members both by their common knowledge of what
it is to live with FSHD and by the ardent desire they all feel to be
part of a concerted effort to discover how to treat the disease and,
ultimately, to cure it.
People who have FSHD must cope with continuing, unrelenting,
unpredictable and never-ending losses. The most unlucky, those who are
affected from birth, are deprived of virtually all the ordinary joys
and pleasures of childhood and adolescence. But no matter at which
stage of life the disease makes itself known, there is never after that
any reprieve from continuing loss of physical ability, or ever for a
moment relief from the physical and emotional pain that FSHD brings in
its train. Every morning, FSHD sufferers wake up to face the reality
that neither a cause for their disease nor any treatment for it has yet
been found.
Insidiously and systematically, FSHD denies a person the full range
of choices in life. FSHD affects the way you walk, the way you dress,
the way you work, the way you wash, the way you sleep, the way you
relate, the way you parent, the way you love, the way and where you
live, and the way people perceive and treat you. You cannot smile, hold
a baby in your arms, close your eyes to sleep, run, walk on the beach,
or climb stairs. Each new day brings renewed awareness of the things
you may not be able to do the next day. This is what life is for tens
of thousands of people affected by FSHD worldwide.
Through the FSH Society, FSHD patients have found ways to be useful
to medical and clinical researchers working on their disease. The FSH
Society acts as a clearinghouse for information on the FSHD disorder
and on potential drugs and devices designed to alleviate its effects.
It fosters communication among FSHD patients, their families and
caregivers, charitable organizations, government agencies, industry,
scientific researchers, and academic institutions. It solicits grants
and contributions from members of the FSH Society, and from
foundations, the pharmaceutical industry, and others to support
scientific research and development. It makes grants and awards to
qualified research applicants. In less than 5 years, the FSH Society
has raised more than $1 million for research and has invested it in two
dozen innovative research programs internationally. One of the FSH
Society's key assets, its Scientific Advisory Board, is composed of
international experts whose awareness of current FSHD research ensures
both that new research is not duplicative but complementary and that it
will fill gaps in existing knowledge. The FSH Society's work in
education, advocacy, and training has led to increased funding in the
United States and abroad. It was a key participant in drafting the
Muscular Dystrophy Community Assistance Research and Education Act of
2001 (MD CARE Act) which in the United States mandates research and
investigation into all forms of Muscular Dystrophy.
The Appropriations Committees in both the U.S. House and the U.S.
Senate have repeatedly instructed the National Institutes of Health
(NIH) to enhance and broaden the portfolio in FSHD and muscular
dystrophy in general. The NIH accounting for the total overall NIH and
the subset of muscular dystrophy appropriations in millions of dollars
for the past 5 years follows:
NATIONAL INSTITUTES OF HEALTH (NIH) APPROPRIATIONS HISTORY SOURCE: NIH/OD BUDGET OFFICE & NIH CRISP DATABASE ON-
LINE
[Dollars in millions]
----------------------------------------------------------------------------------------------------------------
NIH MD MD FSH FSHD FSHD
Fiscal year overall research percent research percent percent
dollars dollars of NIH dollars of MD of NIH
----------------------------------------------------------------------------------------------------------------
2000............................................. $17,821 $12.6 0.071 $0.4 3.18 0.0022
2001............................................. 20,458 21.0 0.103 0.5 2.38 0.0024
2002............................................. 23,296 27.6 0.118 1.3 4.71 0.0056
2003............................................. 27,067 39.1 0.144 1.5 3.83 0.0055
2004E............................................ 27,887 40.2 0.144 2.7 6.71 0.0097
----------------------------------------------------------------------------------------------------------------
Due to major initiatives from the volunteer health agencies and the
extramural community of researchers, FSHD research at the NIH and
funding through the NIH is moving ahead at a steady pace though
seemingly incredibly slow for those of us suffering from FSHD.
Notwithstanding these positive changes at the NIH as well as major
cooperative initiatives from the volunteer health agencies and the
extramural community of researchers, we realize that major changes are
slow but we are hopeful that this year the NIH will initiate new and
increased funding for FSHD.
Funding increases for FSHD as related to the entire muscular
dystrophy portfolio are not keeping pace with all muscular dystrophy.
FSHD is the third most prevalent form of muscle disease and a common
muscular dystrophy. Yet, in 2003 it received only 3.83 percent of the
total NIH wide muscular dystrophy portfolio and that number has
improved slightly to an estimated 6.71 percent for fiscal year 2004.
Mr. Chairman, as you know, the National Institute of Child Health
and Human Development (NICHD), the National Institute of Arthritis and
Musculoskeletal Disorders (NIAMS), and, the National Institute of
Neurological Disorders and Stroke (NINDS) are three of the National
Institutes of Health (NIH) institutes called upon by the Muscular
Dystrophy Community Assistance Research and Education Act of 2001 (MD
CARE Act) to develop a research plan for muscular dystrophy (MD)
research and education conducted through the National Institutes of
Health. Certainly, other NIH institutes will be called into action
where appropriate such as NHLBI, NEI, NIA, NIMH, NHGRI, NCRR, FIC, and
OD.
NATIONAL INSTITUTES OF HEALTH (NIH) MUSCULAR DYSTROPHY AND FSHD APPROPRIATIONS HISTORY SOURCE: NIH/OD BUDGET
OFFICE & NIH CRISP DATABASE ON-LINE
[In millions of dollars]
----------------------------------------------------------------------------------------------------------------
Total NIH NIAMS NINDS NICHD NIH wide
Fiscal year dollars dollars dollars dollars dollars
on MD on MD on MD on MD on FSHD
----------------------------------------------------------------------------------------------------------------
2000..................................................... 12.6 4.8 4.9 1.2 0.4
2001..................................................... 21.0 9.2 8.2 0.5 0.5
2002..................................................... 27.6 11.1 9.8 0.6 1.3
2003..................................................... 39.1 15.5 13.2 4.5 1.5
2004E.................................................... 40.2 15.9 13.5 4.7 2.7
2005E.................................................... 41.0 16.3 13.7 4.8 2.8
----------------------------------------------------------------------------------------------------------------
In fiscal year 2004 year-to-date, the National Institute of Child
Health and Human Development (NICHD) does not have a single research
grant or project directly focused or covering FSHD. NICHD is spending
$0 out of an estimated $4.7M on directly titled FSHD projects. NICHD is
spending 0 percent of its muscular dystrophy budget on FSHD.
In fiscal year 2004 year-to-date, the National Institute of
Arthritis and Musculoskeletal Disorders (NIAMS) is funding two directly
titled projects on FSHD and the NIH FSHD Research Patient Registry. The
directly titled grants and contracts are 5-R21-AR-48318-03 at $198,000,
5-R21-AR-48327-03 at $125,000, and, 3-N01-AR-02250-004 $175,754.
Directly focused and titled research grants on FSHD actually decreased
in fiscal year 2004 due to the expiration of a third R21 and no new
directly titled and relevant projects being funded. No new projects
directly titled and focused on FSHD have been initiated in the past 3
years. Not a single one. The total direct expenditure from the lead
institute on FSHD muscular dystrophy, the NIAMS, was $498,754. The
NIAMS is spending 3.1 percent of its total muscular dystrophy budget on
FSHD. Something is definitely and clearly wrong with this picture.
In fiscal year 2004 year-to-date, the National Institute of
Neurological Disorders and Stroke (NINDS) is funding seven directly
titled projects on FSHD and the NIH U54 Cooperative Research Center at
the University of Rochester. The NINDS is currently funding four R21
style grants, two R01 style grants, the U54 MD CRC, and the NIH FSHD
Research Patient Registry. NINDS has increased its portfolio by one R21
grant, two R01 grants and one U54 Cooperative Research Center in the
last year. The NINDS is spending 16.3 percent of its total muscular
dystrophy budget on FSHD. The NINDS has shown an uncanny ability to
move the field of FSHD research ahead with many excellent research
projects as well as sponsoring the unprecedented NIH Cooperative
Research Center. The second request for applications for the next round
of Wellstone Muscular Dystrophy Centers has just been announced. The
late Senator Wellstone would have been proud of the achievements made
to date in the area of muscular dystrophy and it is very befitting and
appropriate that the muscular dystrophy research centers create a
living memory for his substantial efforts.
While it is recognized that research grants, grant applications and
interest of the researchers may ebb and flow, we are seriously
concerned and perplexed with the total lack of presence by the NICHD in
FSHD and weak showing of FSHD grants and the dip in direct FSHD support
by the NIAMS, ostensibly the lead institute at the NIH, on muscular
dystrophy. FSHD is the third most prevalent form of muscular dystrophy
and the NIAMS has 3.1 percent of its dystrophy portfolio allocated to
this disease. In the case made that the NIH is not receiving enough
grants applications for FSHD, it can be said that the volunteer health
agencies and extramural community of researchers have done everything
in our power to grow the area of research and to promote new
researchers and research projects. The NIH needs to recognize that
there is a systemic problem as relates to FSHD and that the extramural
research community needs to know that there are specific grant
mechanisms and announcements with money associated.
The NINDS, NIAMS, NICHD and relevant NIH institutes understand that
FSHD is a unique disease and that there are exciting breakthroughs
around understanding the molecular basis of FSHD. Elucidation of the
molecular pathogenic pathways of the FSHD disease is instrumental to
improved patient diagnosis, counseling, management and treatment. It is
now generally accepted that FSHD is caused by a deletion (contraction)
of D4Z4 repeats on the chromosome 4q. New mutations are frequently
encountered and approximately half of cases seem to be due to somatic
rearrangements. An interesting gender difference in disease expression
in mosaic patients--males are more susceptible to disease--suggest a
hormonal modulation of the phenotype. FSHD is associated with a genomic
rearrangement and it is unlikely that the D4Z4 deletion structurally
compromises a putative FSHD gene. Evidence strongly supports a model in
which the D4Z4 contraction induces a change in the chromosomal
environment, more specifically the chromatin structure, which in its
turn modulates the gene expression of gene(s) in cis or in trans. This
may occur by a spreading or looping mechanism, or more speculatively,
by a mechanism similar to transvection as chromosome ends of 4q and 10q
seem to exhibit a higher pairing frequency and other forms of cross
talk. However, identification of the exact molecular mechanism and the
crucial target gene(s) has still to be done. There is increasing
evidence for FSHD-specific changes in the chromatin structure and the
histone code. Most arguments suggest a unique (novel) pathogenic
mechanism behind FSHD. Elucidation of this intricate molecular network
is instrumental to the development of evidence-based treatment (and
preventive) strategies.
The following is a non-exhaustive list of top priority research
targets and areas for investigation that has been given by FSHD
research experts to the NIH for consideration as the NIH research plan
is developed. The order is not intended to indicate priority rating.
(1.) Detailed characterization of individual candidate genes on
chromosome 4q; (2.) Identification of the difference between 4qA and
4qB; only short 4qA is causing FSHD; (3.) The molecular causes and
consequences of the exchange between 4q and 10q; (4.) Chromatin
structure and nuclear organization--histone code; methylation,
acetylation etc.; (5.) Establishment of the gene expression modulation
on chromosome 4q and genome-wide; (6.) Development of functional models
in vitro (cellular) and in vivo (transgenic); (7.) Implementation of
systems biology (integrated -omics and bioinformatics) to reveal
molecular and metabolic pathways involved; (8.) Harmonize and
standardize molecular diagnostic procedures; (9.) Systematic
ascertainment and characterization of (homogenous) patient populations
for clinical trials; (10.) Generation of tools and reagents to monitor
(pharmacological, training, or gene therapy) interventions; (11.)
Identification of additional FSHD loci and genes.
Congress has been very generous with the NIH. Congress has
repeatedly mandated more effort in muscular dystrophy research in
general and FSHD research in particular. But this is not happening. We
ask Congress to continue its support for the overall budget increases
for the NIH as this will alleviate the serious budget constraints faced
by this most remarkable federal agency. We also ask that Congress
request an explanation from the program staff and Directors of the NIH
NIAMS and NICHD for the inability to do better in the area of FSHD
despite repeated Congressional requests. We implore Congress to request
the NIH to specifically build the research portfolio on FSHD through
all available means, including re-issuing specific calls for research
on FSHD at an accelerated rate, to make up for historical and present
neglect.
Mr. Chairman, we trust your judgment on the matter before us. We
believe the Committee should explore why muscular dystrophy in general
and FSHD in particular has been left behind in the great rise in
research support at the NIH. Frankly, we are extremely frustrated that
amid a huge increase in funding and strong unambiguous expressions of
Congressional support, the NIH commitment in facioscapulohumeral
muscular dystrophy (FSHD) is so feeble. Mr. Chairman thanks to your
extraordinary efforts, consideration and work in this area I have hope
that we will find solutions and that hope keeps me going.
Mr. Chairman, again, thank you for providing this opportunity to
testify before your Subcommittee.
______
Prepared Statement of the American Psychological Society
SUMMARY OF RECOMMENDATIONS
--As a member of the Ad Hoc Group for Medical Research Funding, APS
recommends $30.78 billion for NIH in fiscal year 2005.
--APS requests Committee support for increased behavioral and social
science research and training at NIH in order to: better meet
the Nation's health needs, many of which are behavioral in
nature; realize the exciting scientific opportunities in
behavioral and social science research, and; accommodate the
changing nature of science, in which new fields and new
frontiers of inquiry are rapidly emerging.
--Committee support is requested for specific behavioral science
activities at a number of individual institutes. This testimony
provides examples to illustrate the exciting and important
behavioral and social science work being supported at NIH.
Mr. Chairman, Members of the Committee: On behalf of our members, I
want to thank the Committee for your leadership in the bipartisan
effort to double NIH budget. As a member of the Ad Hoc Group for
Medical Research Funding, the American Psychological Society recommends
$30.78 billion for NIH in fiscal year 2005.
While the process of doubling the budget of NIH was completed on
schedule, by no means is our work finished. We must think of that
process not as a culmination, but as the beginning of something
miraculous in the world of science and discovery. Within NIH budget, my
testimony focuses on the behavioral and social science research
activities of NIH.
OVERVIEW--BASIC AND APPLIED PSYCHOLOGICAL RESEARCH RELATED TO HEALTH
The effects of behavior on health are indisputable. Many serious
health conditions--heart disease, lung disease, diabetes,
schizophrenia, AIDS, and so many more--are behavioral in origin.
Consider, for example, the devastating health consequences of smoking,
drinking, taking drugs, engaging in risky sexual behaviors. None of
these conditions can be fully understood without an awareness of the
behavioral and psychological factors involved in causing, treating and
preventing them.
APS members include thousands of scientists who, with NIH support,
conduct basic, applied, and clinical research related to physical and
mental health at our Nation's leading universities and colleges.
Virtually every institute at NIH supports some amount of psychological
science. 24 of the 27 institutes at NIH fund behavioral science
research, and seven institutes commit over $100 million to this
enterprise. Six institutes commit over 20 percent of their resources to
behavioral science research. That places these pursuits squarely at the
forefront of the most pressing health issues facing this nation. We ask
that you continue to help make behavioral research more of a priority
at NIH, both by providing maximum funding for those institutes where
behavioral science is a core activity, and by encouraging NIH to
advance a model of health that includes behavior in deciding its
scientific priorities.
BEHAVIORAL SCIENCE RESEARCH TRAINING--A GUARANTEED INVESTMENT
The National Academy of Sciences is currently conducting its
congressionally authorized study of research personnel needs with
regard to the National Research Service Awards. In recent years, NIH
has chosen to only implement the recommendations of NAS selectively, if
at all. NAS produces unbiased, highly analytical reports, and they
should receive more attention from all of the NIH institutes. This is a
serious issue in behavioral science at NIH, where the demand for
behavioral science investigators at NCI, NIMH, and other institutes
outpaces the current supply of behavioral science researchers. In order
to meet the future needs of research in health and behavior, NIH must
have a comprehensive training strategy in place today, one that focuses
on training young investigators in the core disciplines of behavioral
and social science research as well as in multidisciplinary
perspectives.
This Committee has expressed interest in this study in the past.
Your colleagues in the House stated in their fiscal year 2004
appropriations report, ``The Committee recognizes the continuing need
for young investigators and clinical scientists, and encourages NIH to
increase its support for research training and loan repayment programs.
The Committee is aware that the National Academy of Sciences is
currently conducting its congressionally authorized study of research
personnel needs with regard to the National Research Training Awards.
This Committee has expressed interest in this study in the past, and is
looking forward to receiving NAS's recommendations with regard to
health research training priorities.''----(H. Rpt. 108-188 p. 97)
I would now like to turn my attention to the behavioral science
research that is taking place at the individual institutes.
NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH)
Strengthening Clinical Science and Evidence Based Treatment.--In
January, the National Institute of Mental Health hosted a conference in
cooperation with the Academy of Psychological Clinical Sciences. Its
goal was to begin a dialogue on the growing gap between psychological
clinical science training and clinical treatment. Building a solid
footing for the training and development of future clinical researchers
was the broad aim of the gathering. The meeting between the Academy and
NIMH brought leaders of the two groups together to outline the
challenges to clinical science training and develop a strategy for
strengthening that training. Also discussed was the need to encourage
more students to pursue research careers, and support the use of
evidence-based treatments by practitioners. We believe this is the
perfect illustration of what Congress had in mind when it chose to
double the NIH budget; applying advances in science and research to the
treatment of those in need, and watching the two fields progress as one
to the benefit of all. We ask the Committee to support the efforts of
NIMH as the institutes takes this very complex first step in the on-
going fight against mental illness.
Basic Behavioral Research at NIMH.--The behavioral science research
branch at NIMH plays a pivotal role at the institute, funding research
in cognitive science, personality and social cognition, and
biobehavioral regulation. Knowledge derived from the investigation of
basic behavioral processes is critical to the specification of
behavioral abnormalities in mental disorders, as well as to the
identification of risk and protective factors and the development of
effective interventions. NIMH is to be commended for promoting the
transfer of knowledge into application. At the same time, basic
behavioral research at NIMH must continue to receive the same strong
support it traditionally receives there. This is crucial, as NIMH is a
de facto source of basic behavioral knowledge that is tapped by many
other institutes. Until other institutes begin to support larger
amounts of basic behavioral science research connected to their
respective missions, it is essential that NIMH's programs of research
into behavioral phenomena such as cognition, emotion, psychopathology,
perception, development, and others continues to flourish. The National
Mental Health Advisory Council has formed a task force that is
currently examining the basic science portfolio of NIMH, including
basic behavioral science. Their charge is to recommend the best course
of research for the future, based on past successes and the current
direction that research is headed in. Basic behavioral research is
critical not only to the mission of NIMH, but also to the health of the
nation. We ask the Committee to encourage NIMH's continued efforts to
strengthen the ties between basic and clinical behavioral research, and
to monitor NIMH's basic behavioral science portfolio in order to ensure
continued progress in our understanding of the causes, treatment, and
prevention of mental illness and the promotion of mental health.
NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS)
NIGMS is the only National Institute specifically mandated to
support research not targeted to specific diseases or disorders. That
legislative mandate also extends to behavioral science research. The
research mission of NIGMS encompasses ``general or basic medical
sciences and related natural or behavioral sciences [emphasis added]
which have significance for two or more other national research
institutes.''----(TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart
11, Sec. 285k) Unfortunately, NIGMS does not now support behavioral
science research or training. This is an enormous oversight, given the
wide range of fundamental behavioral topics with relevance to a variety
of diseases and health conditions. Congress addressed this issue for
the past 5 years in the reports on the fiscal year 2000, fiscal year
2001, fiscal year 2002, fiscal year 2003, and fiscal year 2004
appropriations for NIH. Specifically, you said: ``The Committee
believes that NIGMS has a scientific mandate to support basic
behavioral research because of the clear relevance of fundamental
behavioral factors to a variety of diseases and health conditions. The
Committee encourages the NIGMS to incorporate basic behavioral research
as part of its portfolio, especially in the areas of cognition,
behavioral neuroscience, behavioral genetics, psychophysiology,
methodology and evaluation, and experimental psychology.''
Last September, Senators Specter, Harkin, and Inouye engaged in a
colloquy on this subject, which appeared in the Congressional Record.
All three of these Senators agreed on the important role that basic
behavioral science plays in our national research agenda. Pressing
national health issues such as post-traumatic stress disorder,
unintentional injuries, and tobacco, alcohol and drug addiction can all
benefit from basic behavioral research. We ask the committee to please
continue its efforts to have NIGMS include basic behavioral research
and research training in its portfolio.
In response to these repeated requests from Congress, a working
group has been established with the charge of examining the basic
behavioral science research portfolio for the whole of NIH. Consisting
of experts in basic behavioral sciences from both inside and outside
NIH, this group was established to offer recommendations on the future
of this research, in terms of both what should be studied and at which
institutes. It will report its findings to the NIH Director's Advisory
Council. In their fiscal year 2005 Congressional Justification
document, NIGMS cited this working group and committed to working with
it. We ask that the committee monitor the progress of this working
group and carefully evaluate its findings.
Basic behavioral research in addiction (significance for NIDA,
NIAAA, NCI and NHLBI), obesity (significance for NIDDK, NHLBI, and
NICHD), behavioral genetics (significance for NIDA, NIAAA, NINDS, and
NHGRI) and neuroscience (significance for NIMH, NINDS, and NHGRI) just
to name a few, are all within the NIGMS mission. We ask the Committee
to direct NIGMS to develop a plan for establishing a basic behavioral
science research program at NIGMS.
NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)
NIDA is committed to bringing the Nation the best possible
prevention and treatment interventions for drug abuse and addiction by
harnessing the power of science. They accomplish this mission through a
wide variety of research centers and projects, all of which are on the
cutting edge of today's science and research methods.
National Drug Abuse Treatment Clinical Trials Network (CTN).--
NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) is
helping bring new medications and behavioral treatments for addiction
to communities. Since its establishment in 1999, the CTN has expanded
from 5 to 17 sites across the country. The mission of the CTN is to
conduct studies of behavioral, pharmacological, and integrated
behavioral and pharmacological treatment interventions of therapeutic
effect in rigorous, multi-site clinical trials to determine
effectiveness across a broad range of community-based treatment
settings and diversified patient populations; and then transfer the
research results to physicians, providers, and their patients to
improve the quality of drug abuse treatment throughout the country
using science as the vehicle.
Brain, Behavior, and Health: An Integrative Approach.--Scientific
understanding has reached a stage where all the elements of the human
brain can be mapped out. NIDA will take a leadership role in working
with other NIH Institutes and Centers and with external groups, to
better understand the interactions among brain, behavior, and health.
Understanding these connections will help us NIDA in the development of
new prevention strategies. Science will find ways to make us better
able to modify behavior in ways that encourage people to take advantage
of existing preventive strategies. All the research initiatives being
put forward by NIDA for fiscal year 2005 will be undertaken within this
integrated approach to brain, behavior, and health.
Comorbidity.--The mentally ill are at very high risk for substance
abuse and addiction. Comorbidity between drug abuse and mental illness
needs to be addressed in order to provide treatments and services that
are truly effective. NIDA would like to expand research to better
understand the comorbid nature of these disorders and to translate this
knowledge into improved prevention and treatment strategies. We ask
this Committee to increase NIDA's budget in proportion to the overall
increase at NIH in order to reduce the health, social and economic
burden resulting from drug abuse and addiction in this Nation.
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA)
NIAAA has broadened its behavioral science portfolio in order to
understand the underlying psychological and cognitive processes that
lead people to drink, and the impact of chronic alcohol abuse on those
processes.
Advancing Behavioral Therapies for Alcoholism.--Behavioral, non-
pharmacological therapies currently are the most widely used method of
treating alcohol dependence and alcohol abuse. To advance the
effectiveness of behavioral therapies, NIAAA is examining approaches to
improving clinicians' abilities to engage and retain adults and
adolescents in treatment. NIAAA plans to expand research on the
mechanisms of action of successful behavioral therapies, behavioral
therapies for alcohol-abusing patients who have psychiatric disorders,
which significantly complicates therapeutic interventions, and
combinations of new medications with behavioral therapies to sustain
recovery.
Underage Drinking.--After the successful launch of NIAAA's
initiative to reduce college drinking through education and
intervention (the web site has received over 12 million hits in just
under 2 years), the attention of the institute has gone one step
further and is now more committed than ever to the eradication of
underage drinking. Risk factors for alcoholism manifest largely in
adolescence, and possibly in childhood. Underage drinking leads to
problems for young people that will have long term effects on their
lives. This is a public health risk that requires the best research,
including behavioral and psychological science research that Congress
can support. The development of better prevention strategies and
learning more about the mind/body interaction, as well as environmental
influences, are some of the steps that NIAAA has taken in this fight
against a formidable and destructive opponent. We ask this Committee to
increase NIAAA's budget in proportion to the overall increase at NIH in
order to reduce the health, social and economic burden resulting from
alcohol abuse and addiction.
NATIONAL CANCER INSTITUTE (NCI)
Having already established itself as a leader among NIH Institutes
in many fields of research, NCI has made enormous advances in the
behavioral sciences.
NCI's Behavioral Research Program.--Scientists estimate that as
many as 50 percent to 75 percent of cancer deaths in the United States
are caused by human behaviors such as smoking, physical inactivity, and
poor dietary choices. NCI's comprehensive behavioral science research
program ranges from basic behavioral science to research on the
development, testing and dissemination of disease prevention and health
promotion interventions in areas such as tobacco use, diet, and even
sun protection. Focusing on transdisciplinary and collaborative
research, NCI's Behavioral Program has expanded to five branches,
including a basic biobehavioral research branch, a health communication
and informatics research branch, and the tobacco control research
branch.
Health Communications.--Recognizing the central role of effective
communication in addressing issues of health and behavior, NCI has also
undertaken a major effort to develop science-based communications
strategies for disseminating information and persuasive messages about
cancer prevention and treatment to the public. Researchers are
exploring innovative strategies for communicating cancer information to
diverse populations, looking at various communication approaches such
as message tailoring and framing with application in multiple
communication channels. These messages draw from a foundation of basic
behavioral and social science research into such issues as how people
learn and remember health information, how they perceive health risks,
and how they are persuaded to adopt healthy behaviors.
We ask Congress to support NCI's behavioral science research and
training initiatives and to encourage other institutes to use these
programs as models.
I would now like to turn to some crosscutting initiatives in which
behavioral research plays a critical role.
NIH Roadmap.--There has been much attention paid in recent months
to the cross NIH initiative known as the ``Roadmap.'' This project will
take NIH into the 21st century by revolutionizing the way the
institutes think about research and its application into and impact on
health services. Transdisciplinary teams of researchers, including
behavioral scientists, will conduct high risk/high reward research that
will put us on a path towards a healthier population. An excellent
example of this transdisciplinary research and the importance of
behavioral science is an RFA for health research training issued under
the Roadmap program entitled: INTERDISCIPLINARY HEALTH RESEARCH
TRAINING: BEHAVIOR, ENVIRONMENT AND BIOLOGY. Among the goals of the RFA
is the study of mental disorders by approaches that integrate
neuroscience, genetics, behavioral science, computational science/
modeling, and clinical sciences, in an attempt to understand the
confluence of genetic, biological, behavioral and environmental factors
involved in the etiology, treatment and prevention of these disorders.
Obesity.--Obesity is a health problem all too often overlooked;
yet, recently it has begun to receive the attention it is warranted. It
is no longer a condition that can be overlooked, as it is the leading
cause of health problems in America, even more so than smoking.
Motivation, counseling, marketing and communication are all important
tools if we are to create a healthier nation led by healthier children.
If we are to see results, the message that we communicate must be
rooted in science and research. Evidence based research, translated
into practice, will ensure safe and effective messages. The use of
science in promoting behavioral changes should not and cannot be
ignored. It has shown us that obesity leads to increased risk of
diabetes, heart disease, and even cancer. The behavioral and
physiological changes that occur during high-risk periods for weight
gain must be clarified. This information can then be used to design
individualized interventions, in order to prevent future weight gains
and obesity. Research in this field benefits several institutes, such
as NHLBI, NICHD, NIDDK, NIA, and NCI.
Sexual Behavior Research and Peer Review.--Recently, much publicity
has been given to research conducted at NIH that involves human
sexuality and sexually transmitted disease. This research is critical
to the health of all Americans, and must continue unimpeded. Recent
attacks on NIH for supporting research in health and behavior are
motivated by objections to particular behaviors or to the populations
being studied. These attacks are intended to stop funding of research
relating to such things as reproductive functioning, sexually
transmitted diseases, substance abuse, and other public health
problems. This research has enormous implications for understanding and
preventing a range of health problems, including HIV and AIDS; problems
of physical, mental and social development in children; violence;
addiction; teen pregnancy; and numerous other conditions that stem from
behavioral threats to health. These problems are not limited to
particular segments of our society; the health and economic
consequences of these behaviors affect individuals, families and
communities of all ethnic backgrounds, professions, and income levels.
Our best and only hope for combating these issues is a robust health
research agenda based on scientific priorities and methods. The
American Psychological Society strongly supports the scientific peer
review system of the National Institutes of Health and we encourage
Congress and the public to reject efforts to undermine that system by
attacking selected grants. NIH's system for evaluating research
proposals ensures that the best science is brought to bear on our
nation's most pressing public health problems. On this subject, NIH
director Zerhouni wrote to Congress: ``I fully support NIH's continued
investment in research on human sexuality, and I believe that the peer
review process has worked properly and provided a level of valuable and
independent view in this important area of research.'' In the interest
of public health, our Nation's leaders must take whatever steps are
necessary to protect the scientific peer review system from the
chilling effects of ideological influences.
It is not possible to highlight all of the worthy behavioral
science research programs at NIH. In addition to those I've discussed
here, many other institutes play a key role in NIH behavioral science
research enterprise. These include the National Institute on Aging, the
National Heart Lung and Blood Institute, the National Institute of
Child Health and Human Development, the National Institute of
Neurological Disorders and Stroke, and within NIH Director's office,
the Office of Behavioral and Social Sciences Research. Behavioral
science is a central part of the mission of each of these, and each
deserves the Committee's support.
This concludes my testimony. Again, thank you for the opportunity
to discuss NIH appropriations for fiscal year 2004 and specifically,
the importance of behavioral science research in addressing the
Nation's public health concerns. I would be pleased to answer any
questions or provide additional information.
______
Prepared Statement of the American Thoracic Society
SUMMARY--FUNDING RECOMMENDATIONS
[In millions of dollars]
------------------------------------------------------------------------
Agency Amount
------------------------------------------------------------------------
National Institutes of Health.............................. 30,000.0
National Heart, Lung and Blood Institute............... 3,165.8
National Institute of Allergy and Infectious Disease... 4,733.3
National Institute of Environmental Health Sciences.... 694.1
Fogarty International Center........................... 71.5
National Institute of Nursing Research................. 148.5
Centers for Disease Control and Prevention................. 7,500.0
National Institute for Occupational Safety and Health.. 306.9
Office on Smoking and Health........................... 130.0
Environmental Health: Asthma Activities................ 70.0
Tuberculosis Control Programs.......................... 528.0
------------------------------------------------------------------------
The American Thoracic Society (ATS) is are pleased to submit our
recommendations for programs in the Labor Health and Human Services and
Education Appropriations Subcommittee purview.
The American Thoracic Society, founded in 1905, is an independently
incorporated, international education and scientific society that
focuses on respiratory and critical care medicine. The Society's
members help prevent and fight respiratory disease around the globe
through research, education, patient care and advocacy. The Society's
long-range goal is to decrease morbidity and mortality from disorders
and life-threatening acute illnesses.
MAGNITUDE OF LUNG DISEASE
Lung disease in America is a serious problem. Each year, an
estimated 342,000 Americans die of lung disease. Lung disease is
responsible for 1 in every 7 deaths, making it America's number three
cause of death. More than 35 million Americans suffer from a chronic
lung disease. In 2002, lung diseases cost the U.S. economy an estimated
$141.8 billion in direct and indirect costs.
Lung diseases represent a spectrum of chronic and acute conditions
that interfere with the lung's ability to extract oxygen from the
atmosphere, protect against environmental or biological challenges and
regulate a number of metabolic processes. Lung diseases include chronic
obstructive pulmonary diseases, lung cancer, tuberculosis, pneumonia,
influenza, sleep disordered breathing, pediatric lung disorders,
occupational lung disease, sarcoidosis, asthma and severe acute
respiratory syndrome (SARS).
The ATS is pleased that the Subcommittee provided increases in the
National Institutes of Health (NIH) and the Centers for Disease Control
and Prevention (CDC) budget last fiscal year. The ATS is pleased that
the Administration and Congress modestly increased the National
Institute of Health (NIH) budget in fiscal year 2004. However, we are
extremely concerned with the President's fiscal year 2005 budget that
proposes a mere 2 percent increase for NIH and signficiant cuts for
CDC. We ask that this Subcommittee recommend a 10 percent increase for
NIH. In order to stem the devastating effects of lung disease, research
funding must continue to grow to sustain the medical breakthroughs made
in recent years. While our statement will focus on selected parts of
the Public Health Service, we are firmly committed to appropriate
funding for all sectors of our nation's public health infrastructure.
COPD
Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading
cause of death in the United States and the third leading cause of
death worldwide. Yet, COPD remains relatively unknown to most
Americans. COPD is the term used to describe the airflow obstruction
associated mainly with emphysema and chronic bronchitis and is a
growing health problem.
While the exact prevalence of COPD is not well defined, it affects
tens of millions of Americans and can be an extremely debilitating
condition. It has been estimated that 13.3 million patients have been
diagnosed with some form of COPD and as many as 24 million more are
undiagnosed.
In 2001, 13.3 million adults, aged 18 and older in the United
States were estimated to have COPD. In addition, according to the new
government data based on a 2001 prevalence survey, 3 million Americans
have been diagnosed with emphysema and 11.2 million are diagnosed with
chronic bronchitis. In 2001, 118,000 people in the United States died
of COPD, with the death rate for women with COPD surpassing the death
rate of men with COPD. COPD costs the U.S. economy an estimated $32.1
billion a year.
Medical treatments exist to address symptom relief and slow the
progression of the disease. Today, COPD is treatable but not curable.
Fortunately, promising research is on the horizon for COPD patients.
Research in the genetic susceptibility underlying COPD is making
progress. Also, there are promising research leads on medications to
repair damage to lung tissue caused by COPD. Additional research is
needed to pursue these leads.
Despite these promising leads, the ATS feels that research
resources committed to COPD are not commensurate with the impact COPD
has on the United States and the world. Clearly more needs to be done
to make Americans aware of COPD, its causes and symptoms. We understand
that the National Heart Lung and Blood Institute (NHLBI) is developing
a public education program on COPD. The ATS supports this effort and
encourages the NHLBI to partner with the patient and physician
community in developing the COPD public education campaign.
Additionally, we recommend the Subcommittee encourage NHLBI to devote
additional resources to finding improved treatments and a cure for
COPD. It affects tens of millions of Americans and can be an extremely
debilitating condition. It has been estimated that 13.3 million
patients have been diagnosed with some form of COPD and as many as 24
million more are undiagnosed.
The ATS is pleased to announce the formation of a new congressional
caucus that will focus on COPD. On March 30, 2004, the Congressional
COPD Caucus officially began its work and the ATS encourages members of
this Subcommittee to join.
ASTHMA
Asthma is a chronic lung disease in which the bronchial tubes of
the lungs become swollen and narrowed, preventing air from getting into
or out of the lung. A broad range of environmental triggers that vary
from one asthma-sufferer to another causes these obstructive spasms of
the bronchi.
Last month, the CDC issued a new report indicating that asthma
rates have risen for the past 10 years. It is estimated that close to
20.3 million people suffer from asthma, including an estimated 6.3
million children. While some children appear to out grow their asthma
when they reach adulthood, 75 percent will require life-long treatment
and monitoring of their condition.
Asthma is expensive. The growth in the prevalence of asthma will
have a significant impact on our nation's health expenditures,
especially Medicaid. The direct medical costs and indirect costs for
asthma are estimated to exceed $14 billion annually. Asthma also
represents the most common cause of school absenteeism due to chronic
disease. In 2001, there were 2 million emergency room visits due to
asthma.
Asthma also kills. In 2001, 4,200 people in the United States died
as a result of an asthma attack. Approximately 65 percent of these
deaths occurred in women. A disproportionate share of these deaths
occurred in African American families.
As the prevalence of asthma has grown, so has asthma research.
Researchers are developing better ways to treat and manage chronic
asthma. Research supported by the National Heart, Lung and Blood
Institute (NHLBI) has discovered genetic components as well as how
infectious disease contributes to asthma. NHLBI researchers have also
developed better animal models to allow expression of selected
asthmatic genetic traits. This will allow researchers to develop a
greater understanding of how genes and environmental triggers influence
asthma's onset, severity and long-term consequences.
Progress is being made to fight the growing asthma epidemic. We are
pleased to report that the fourth American Lung Association Asthma
Clinical Research Centers (ACRC) Network study began in September 2003.
That study hopes to determine if patient education and the ways of
presenting asthma drugs can improve treatment. The first ACRC study
concluded that a considerable reduction in the number of
hospitalizations, resulting in lower health care costs, could be
achieved if all people with asthma were vaccinated for influenza. The
19 ACRC centers around the United States evaluate treatment, education
and other intervention strategies for asthma in adults and children.
This network is one of the largest clinical research networks in the
United States and will continue to develop innovations that will
directly benefit patients.
The ATS also feels that the Centers for Disease Control and
Prevention (CDC) must play a leadership role in the ways to assist
those with asthma. National statistical estimates show that asthma is a
growing problem in the United States. However, we do not have accurate
data that provide regional and local information on the prevalence of
asthma. To develop a targeted public health strategy to respond
intelligently to asthma, we need locality-specific data. CDC should
take the lead in collecting and analyzing this data.
Last year, Congress provided approximately $37 million for the CDC
to conduct asthma programs. CDC will use these funds to conduct asthma
outreach, education and tracking activities. We recommend that CDC be
provided $70 million in fiscal year 2005 to expand programs and
establish grants to community organizations for screening, treatment,
education and prevention of childhood asthma.
In the past, Congress enacted legislation that directs the National
Asthma Education and Prevention Program at NHBLI to develop a plan for
the federal government to respond to the growing asthma epidemic in the
United States. This plan should bring together key public and private
organizations to develop a national asthma plan to coordinate the many
elements of an effective public health response to asthma. Components
of a national plan should include research, surveillance, patient and
provider education, community awareness, indoor and outdoor air
quality, and access to health care providers and medication.
TUBERCULOSIS
The first lung disease research began with the treatment of those
who had tuberculosis (TB) (TB) or ``consumption'', as it was called at
the turn of the 20th century. Tuberculosis is an airborne infection
caused by a bacterium, Mycobacterium tuberculosis. Tuberculosis
primarily affects the lungs but can also affect other parts of the
body, such as the brain, kidneys or spine.
Tuberculosis is spread through coughs, sneezes and close proximity
to someone with active tuberculosis. People with active tuberculosis
are most likely to spread the disease to others they spend a lot of
time with, such as family members or coworkers. It cannot be spread by
touch or sharing utensils used by an infected person.
Tuberculosis takes a toll on the U.S. economy, with total direct
and indirect costs of $1.1 billion. There are an estimated 10 million
to 15 million Americans who carry latent tuberculosis infection. Each
has the potential to develop active tuberculosis in the future. About
10 percent of these individuals will develop active disease at some
point in their lives. In 2003, there were 14,871 cases of active
tuberculosis reported in the United States. This is only a 1.4 percent
decline in the number of cases reported in 2002 and is the smallest
annual decrease reported since 1992, the year the incidence of
tuberculosis peaked during a period of resurgence from 1985-1992.
Upon review of this information, many have concluded that a cycle
of neglect has begun, reminiscent of the previous resurgence. The ATS,
in collaboration with the National Coalition for Elimination of
Tuberculosis, recommends an increase of $105 million for TB control in
fiscal year 2005 to allow the CDC undertake an unprecedented
initiative, Intensified Support and Activities to Accelerate Control
(ISAAC) to enhance, maximize and target resources to sustain the
momentum of the past decade and accelerate the control and elimination
of tuberculosis. ISAAC targets tuberculosis in African Americans,
tuberculosis along the United States-Mexico border, allows for
universal genotyping of all culture positive TB cases and expands
clinical trials for new tools for the diagnosis and treatment of
tuberculosis.
In the summer of 2000, the Institutes of Medicine (IOM) published a
report, entitled: Ending Neglect: The Elimination of Tuberculosis in
the United States. The report documents the cycles of attention and
progress toward TB elimination, the periods of insufficient funding and
the re-emergence of tuberculosis. The IOM report provides the United
States with a road map of recommendations on how to eliminate
tuberculosis in the United States. The IOM report identifies needed
detection, treatment, prevention and research activities. The report
concludes that with proper funding, organization of prevention and
control activities and research for development of new tools,
tuberculosis can be eliminated as a public health problem in the United
States. We have endorsed the IOM report and its recommendations. The
components of ISAAC begin to fully implement the recommendations of the
IOM.
While declining overall TBB rates is good news, the slowing of the
decline in rates and the emergence and spread of multi-drug resistant
TtuberculosisB poses a significant threat to the public health of our
nation. Increased support is needed if the United States is going to
continue progress toward the elimination of tuberculosis.
The NIH also has a prominent role to play in the elimination of
tuberculosis. Currently there is no highly effective vaccine to prevent
TB transmission. However, the recent sequencing of the TB genome and
other research advances has put the goal of an effective TB vaccine
within reach. The National Institute of Allergy and Infectious Disease
has developed a Blueprint for Tuberculosis Vaccine Development. We
encourage the subcommittee to fully fund the TB vaccine blueprint.
Fogarty International Center TB Training Programs
The Fogarty International Center (FIC) at NIH provides training
grants to U.S. universities to teach AIDS treatment and research
techniques to international physicians and researchers. The goal is to
develop a cadre of health professionals in the developing world who can
begin controlling the global AIDS epidemic.
Because of the link between AIDS and TB infection, the FIC has
created supplemental TB training grants for these institutions to train
international health care professionals in the area of TB treatment and
research. This supplemental program has been highly successful in
beginning to create the human infrastructure to treat the nearly 2
billion people who have tuberculosis worldwide.
However, we believe TB training grants should not be offered
exclusively to institutions that have received AIDS training grants.
The TB grants program should be expanded and open to competition from
all institutions. The ATS recommends that Congress provide an
additional $3 million for the FIC to expand the TB training grant
program from a supplemental grant to an open competition grant.
NIOSH--RESEARCHING AND PREVENTING OCCUPATIONAL LUNG DISEASE
The ATS is extremely concerned that the president's budget proposes
to cut the National Institute of Occupational Safety and Health (NIOSH)
extramural research program. We strongly encourage this subcommittee to
reject the Administration's proposed cut to the NIOSH research program.
Occupational safety and health research are valuable and deserve
additional funding.
Protecting the health of our nation's workforce will require
research, training, tracking and new technologies. We recommend that
the Subcommittee provide a $30 million increase for the NIOSH budget.
The $30 million increase will be used for the NIOSH Emergency
Preparedness agenda, including activities at the National Personal
Protective Technology Laboratory, improve workers' safety, and invest
in protective technology that will help our nation respond to the
growing threat of bioterrorism. In addition, increased NIOSH funding is
needed for NIOSH-sponsored prevention, intervention and information
programs. These programs respond to existing workplace health programs,
conduct prevention education programs, and work with labor and industry
groups to lower the risk of workplace injury and illness.
Finally, the overall funding increase for NIOSH will increase
training of occupational health professionals in the United States. A
recent IOM Report, Safe Work in the 21st Century: Education and
Training Needs for the Next Decades Occupational Safety and Health
Personnel, identified a growing shortage of trained occupational health
professionals in the United States. Unlike the majority of medical
subspecialties, occupational health professionals do not receive
Medicare training support. One such program is the Capacity Building
for Worker safety and health that includes training opportunities for
occupational health professionals at NIOSH--sponsored Centers of
Excellence. We believe more funds are needed in order to track the
incidence of serious work-related illnesses and injury.
PHYSICIAN WORKFORCE SUPPLY
As the number of people diagnosed with lung diseases rises, we need
to ask, who will be treating lung disease patients in the future? The
ATS is also concerned about the supply of physicians in the United
States. The ATS is concerned about the supply of physicians in the
United States. A recent study published in the Journal of the American
Medical Association predicts that there will be an acute shortage of
physicians trained to treat patients with critical care illness and
lung disease starting in 2007.\1\ While the study focuses on supply of
pulmonary/critical care physicians, what is driving the shortage is the
predicated increase in demand for physician services caused by the
aging of the U.S. population.
---------------------------------------------------------------------------
\1\ D. Angus, et al. Current and Project Workforce Requirements for
Care of the Critically Ill and Patients with Pulmonary Disease: Can We
Meet the Requirements of an Aging Population? JAMA 2000; 284:2762-2770.
---------------------------------------------------------------------------
Policy makers have given much thought and attention to how the
aging population will affect Social Security and other programs for the
elderly. Significant attention has been given to the acute shortage of
nurses. However, such forward thinking does not seem to be applied to
our physician workforce.
We are pleased that Bureau of Workforce Analysis at the Health
Resources and Services Administration (HRSA) will be conducting a study
on physician workforce supply in the United States. We are hopeful that
the HRSA study will confirm the looming shortage of physicians in the
United States and make policy recommendations on how best to add
physicians to the workforce before it becomes a serious crisis.
LUNG-DISEASE OPPORTUNITIES AND ADVANCES
Pulmonary researchers have made significant advances in lung
disease research. NHBLI has identified areas of lung disease research
that it will be exploring in the next year. One area of focus will be
acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).
NHLBI created Specialized Centers of Clinically Oriented Research
(SCCOR) in translational research in acute lung injury. Patients
experiencing ALI and ARDS suddenly develop severe lung inflammation
that results in hypoxemia, loss of lung compliance and possibly multi-
organ system failure. The SCCOR program will foster multi-disciplinary
basic and clinical research related to ALI and ARDS, which will
eventually have a positive impact on their prevention, diagnosis and
treatment.
Another area of focus is COPD and lung cancer research. Nearly a
quarter of a million Americans die each year of either COPD or lung
cancer. NHLBI hopes to address the gap in knowledge that a common
pathogenetic mechanism may be involved as a risk factor for COPD and
lung cancer. The research will focus on a search for the similarities
of the cellular and molecular mechanisms that lead to COPD and lung
cancer. This new research could have important implications for the
prevention and management of both diseases.
One area of new and emerging research conducted by the NHBLI deals
with Sleep-disordered breathing (SDB). SDB is a medical condition
associated with upper airway obstruction and cessation of breathing
that leads to repeated episodes of asphyxia during the night. SDB is
very prevalent in the U.S. population with conservative estimates set
at 2 percent to 3 percent of all children, 5 percent of middle age
adults, and in excess of 15 percent of the aged population. The major
health-related implications and morbid consequences of SDB include the
neurocognitive and cardiovascular morbidities, depression,
hypertension, increased frequency of myocardial infarction and stroke,
and increased frequency of motor vehicle accidents due to the increased
sleepiness induced by the disruption of sleep in SDB patients. Both the
frequency of SDB and its consequences are anticipated to increase in
the next decades due to the aging of the overall U.S. population and
the ongoing epidemic of obesity that afflicts our country. The ATS
supports the need for more research into the causes, diagnosis and
treatment of SDB.
In conclusion, lung disease is a growing problem in the United
States. It is this country's third leading cause of death, responsible
for 1 in 7 deaths. The lung disease death rate continues to climb.
Overall, lung disease and breathing problems constitute the number one
killer of babies under the age of 1 year. Worldwide, tuberculosis kills
3 million people each year, more people than any other single
infectious agent. The level of support this Subcommittee approves for
lung disease programs should reflect the urgency illustrated by these
numbers.
______
Prepared Statement of the American Society of Clinical Oncology
The American Society of Clinical Oncology (ASCO) is the world's
leading professional society representing more than 20,000 physicians
and health care providers engaged in cancer treatment and research.
ASCO appreciates the opportunity to submit a statement for the
Subcommittee record. This is a time when cancer clinical researchers
faces tremendous challenges and also significant opportunities, and we
recommend several actions that will ensure the efficient translation of
basic research findings into new treatments.
ASCO members owe a tremendous debt to this Subcommittee and the
Congress for your leadership over the past decade in boosting the
funding for the National Institutes of Health (NIH). The doubling of
the NIH budget between fiscal year 1999 and fiscal year 2003 is a
particularly impressive accomplishment, but Congress acted as a
steadfast friend to research for many years before the period by
guaranteeing that NIH had the resources it needed to support basic,
translational, and clinical research.
With the resources that have been provided to NIH and to biomedical
researchers across the country, our knowledge of the genetic,
molecular, and cellular basis of many diseases has increased
dramatically. There has been a revolution in our understanding of
cancer, and the traditional approach to cancer, which was based on the
site of the cancer, is changing. Instead of seeking to develop
treatments based on the location of the cancer, we are instead looking
for treatments that correct the underlying genetic or molecular defect
that causes the disease. The promise of cancer research has never been
greater, although realizing that promise will be difficult and will
require significant resources.
ASCO and others in the research community are aware of the current
budget situation and the effect it will likely have on NIH
appropriations. Nevertheless, we strongly urge that Congress make every
effort to boost NIH funding, as continued funding increases will ensure
that the basic research progress made in recent years will continue and
that those basic research findings will be translated to new
treatments. We endorse the recommendation of the Federation of American
Societies for Experimental Biology and others in the research community
that NIH funding be increased by 10 percent in fiscal year 2005, to a
total of $30.6 billion.
THE NIH ROADMAP
The leaders of NIH have given serious consideration to reforms that
will equip NIH to remain the world's leading biomedical research
institute in the 21st century. ASCO believes that the three main areas
of focus of the Roadmap--establishing new pathways to discovery,
developing research teams of the future, and re-engineering the
clinical research enterprise--are appropriate, and achieving these
goals of the Roadmap would equip researchers for developing new
treatments.
We are gratified that the NIH Roadmap emphasizes the need to re-
engineer the clinical research enterprise. Although the cancer clinical
trials system at the National Cancer Institute (NCI) is strong and has
been a major factor in advances in cancer care, we welcome the NIH
Roadmap's critical look at clinical trials systems as a means of
improving those systems. Clinical researchers must be provided the
tools, including informatics and tissue or specimen repositories, to
conduct their work efficiently, and the Roadmap acknowledges the need
for those investments.
In addition, the drafters of the NIH Roadmap properly identify a
crisis in clinical research training and suggest steps to enhance
training. ASCO has initiated programs to improve the training of cancer
clinical researchers, and we welcome the special attention that NIH is
directing to this issue.
Implementation of the NIH Roadmap initiatives cannot be
accomplished at the expense of successful core programs at NCI and
other institutes, but Congress should foster the important reforms
outlined in the Roadmap.
THE CANCER CLINICAL TRIALS SYSTEM
NCI has supported the development of a sophisticated system for
conducting clinical trials that depends heavily on the participation of
community oncologists, along with oncologists at cancer centers around
the nation. Patients who are treated in the community have the option
of enrolling in clinical trials, as their oncologists are almost
certainly part of the nation's clinical trials system. This system of
treatment, where the majority of cancer patients receive their care in
the community and have access to the full range of treatment options,
including clinical trial enrollment, has evolved over the last 30
years.
The Medicare Modernization Act of 2003 (MMA) changes dramatically
the method by which cancer chemotherapy services provided by
oncologists in their offices are reimbursed by Medicare. The current
system of payment for cancer chemotherapy drugs will be shifted from an
average wholesale price methodology to an average sales price
methodology, and accompanying reductions will be made in reimbursement
for the services required to administer chemotherapy in the physician's
office. The estimates are that, in the aggregate, reimbursement for
cancer chemotherapy services will not decline from 2003 to 2004.
However, ASCO's preliminary predictions suggest a dramatic reduction in
payment for cancer care beginning in January 2005. One of the tasks
facing ASCO is to monitor this situation carefully and report to
Congress the effects of reimbursement changes.
We realize that this Subcommittee does not have jurisdiction over
Medicare. We are raising this issue with the Subcommittee, however,
because the potential effects of Medicare reimbursement changes include
a serious threat to the clinical research enterprise. In surveys that
ASCO has conducted among its members who are engaged in office-based
practice, a significant number of those surveyed indicate that, in
light of the potential Medicare reimbursement changes in 2005, they
will be less inclined to participate in clinical research. Some members
have already reported that they have stopped participating in clinical
trials. ASCO members have for years reported that the per person
payment they receive for NCI-funded clinical trials is inadequate to
pay the costs associated with enrolling a patient on trial and
collecting and reporting data from the trial. These physicians have
subsidized NIH-funded trials with payments from industry-sponsored
trials and from clinical income. According to reports from the field,
oncologists will not be able to continue this cross-subsidization,
because the funds simply will not be available to support this
longstanding ad hoc practice.
The task ahead of us now is translating the significant advances in
our fundamental knowledge of cancer into new treatments. In no area of
research are the opportunities greater than in cancer, and those
opportunities will be realized by the rapid completion of clinical
trials testing new therapies. If the community physicians who enroll
the majority of patients in clinical trials are no longer actively
participating in clinical research, the clinical research enterprise
will be slowed.
At the same time that ASCO monitors the effects of MMA cancer
reimbursement changes and develops appropriate reform proposals,
Congress should encourage NCI to undertake a review of the current
system of paying for clinical trials. An immediate action that NCI can
take is improving the payments to physicians for enrolling cancer
patients in trials. Modest increases in payments have been approved by
NCI in recent years, but they are inadequate. In addition, ASCO
believes that more substantial changes--beyond a boost in the per-
patient rate of payment--may be necessary to ensure that oncologists at
cancer centers and in the community continue to participate in clinical
research and that all other players in clinical research, including NCI
and industry, remain committed to participation in cancer clinical
research. This is an urgent matter, and we recommend action by NCI to
address it.
MINORITY ENROLLMENT IN CLINICAL TRIALS
It is estimated that fewer than 5 percent of adults with cancer
enroll in clinical trials. The rate of participation is even lower
among minorities. ASCO commends NCI for its efforts to boost
involvement of African American, Hispanic, Asian American, and American
Indian patients in clinical trials, in part through the Minority-Based
Community Clinical Oncology Program. This program includes 11 minority-
based CCOPs and involves more than 40 hospitals and 100 minority
investigators. We also support the Special Population Networks, which
involve research institutions and community providers in investigations
of the causes of cancer disparities. This knowledge is vital to our
efforts to erase cancer disparities, and NCI is properly investing
resources in this research initiative.
RESEARCH TO COMBAT BIOTERRORISM AND ENSURE HOMELAND SECURITY
ASCO is pleased that the biodefense request for fiscal year 2005
includes $47 million for the Public Health and Social Services
Emergency Fund, which will support targeted research to develop medical
countermeasures to treat nuclear or radiological injuries. Cancer
researchers have expertise that will be critical to this effort, which
includes: (1) developing drugs to prevent injury from radiological
exposure; (2) improving methods for measuring radiological exposure,
and (3) developing methods or drugs to restore injured tissues and
eliminate materials from contaminated tissue. Cancer researchers are
actively engaged in research to understand the late and long-term
effects of cancer treatment, including chemotherapy and radiation
therapy, and their expertise in these research areas equips them to be
engaged in the targeted research that will likely be funded by the
Public Health and Social Services Emergency Fund.
ASCO appreciates the opportunity to submit this statement.
Congress, through its strong support of NIH, has facilitated an
explosion of knowledge about cancer and other serious and life-
threatening illnesses. Although we are poised to translate those basic
research findings into new treatments, the clinical trials system for
testing treatments is fragile. ASCO urges Congress to protect the
clinical trials system, so that we can capitalize on the tremendous
investment in basic research during the past decade.
______
Prepared Statement of the National Multiple Sclerosis Society
Mr. Chairman and distinguished members of the Subcommittee, we
appreciate the opportunity to submit written testimony on behalf of the
National Multiple Sclerosis Society. The Society was founded in 1946.
Since its inception, the Society's highest priority has been to support
research aimed at finding the cause of MS, better treatments, and a
cure. In 2004, the National MS Society will spend over $31 million on
MS research supporting over 300 MS investigations. By the end of 2004,
the Society cumulatively will have expended some $420 million since
awarding its first three grants in 1947. This represents the largest
privately funded program of basic, clinical, and applied research and
training related to MS in the world.
Multiple sclerosis is a chronic, unpredictable and often disabling
disease of the central nervous system. Symptoms range from numbness in
the limbs, to loss of vision, and in some instances partial or total
paralysis. The progress, severity and specific symptoms of MS in any
one person can vary and cannot yet be predicted, but advances in
research and treatment are giving hope to those affected by the
disease.
The federal investment in the National Institutes of Health (NIH)
plays a major role in MS research. There are two institutes that
conduct or fund the majority of MS research: the National Institute of
Neurological Disorders and Stroke (NINDS) which funds 75 percent, and
the National Institute of Allergy and Infectious Diseases (NIAID) which
funds about 20 percent.
For fiscal year 2004 and fiscal year 2005, it is estimated that NIH
expenditures on MS research will be $101.3 million and $102.8 million,
respectively. While this demonstrates a good NIH investment in MS, the
amount seems low considering that the annual direct and indirect
disease cost is approximately $20 billion for all people with MS in the
United States.\1\
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\1\ Based on a 1994 Duke University study, indexed for 2002 by the
National MS Society, the average annual cost of MS is estimated at
$50,000 per person due to lost wages, increased medical care and other
expenses. Nationwide, there are an estimated 400,000 people with MS.
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To ensure an adequate federal investment in MS research, the
Society has a three-pronged strategy: (1) request funding for specific
research priorities relevant to MS; (2) encourage collaboration across
NIH institutes and between NIH and outside organizations; and (3)
advocate for a 10 percent funding increase for NIH overall in fiscal
year 2005. The National MS Society has had a long and productive
relationship with NIH, particularly with NINDS. Our founder Sylvia
Lawry helped spearhead the legislation that established NINDS in 1950.
Intramural scientists from NINDS serve on our scientific advisory
committees and help the Society make research project decisions. These
outstanding scientists/physicians volunteer their time to ensure that
the research supported by the Society and NIH are in concert, and not
in opposition.
FUNDING RESEARCH PRIORITIES RELEVANT TO MS
The National MS Society will continue to pursue research
opportunities with NIH in priority areas that are key to furthering the
understanding of MS. We also will closely monitor NIH's progress in
expanding its commitment to MS research as suggested by Congress.
Last year, as part of our NIH advocacy efforts, the Society had the
following congressional ``report language'' added by the House and
Senate Appropriations Conference Committee as an instruction to NIH in
the fiscal year 2004 omnibus appropriations package:
``The conferees urge NINDS to increase its overall investment in
multiple sclerosis (MS) research. Special emphasis on imaging,
biological markers and clinical trials for new therapeutics should be
areas of high priority. The conferees are pleased to note the
development of a joint symposium on MS genetics sponsored by NINDS and
the National MS Society, and encourage the Institute to take a more
active role at the NIH in furthering MS genetics research by developing
collaborative strategies with the National Human Genome Research
Institute and other relevant NIH institutes. The conferees request that
NIH report back to Congress no later than September 30, 2004 with
progress in its efforts to expand its commitment to multiple sclerosis.
The conferees also are pleased to note a major success in past years in
the creation of a joint collaborative research program in `gender and
immunity' between the National Institute on Allergy and Infectious
Diseases (NIAID) and a major voluntary association for the disease, in
which NINDS participates. The conferees encourage NINDS to seek similar
collaborative activities related to MS.''
The Society was pleased that late in 2003 NINDS funded a 5-year $30
million clinical trial that will test the effects of combining two of
the MS injected therapies against the use of a single therapy. As part
of this clinical trial, NINDS is including an additional $3-4 million
to study the correlation between the clinical course of MS and data
from biological markers (magnetic resonance imaging). The Society also
was pleased that in 2003 NINDS and NMSS co-sponsored a scientific
workshop on the role of genetics in MS. As an outcome of this workshop,
the Society is looking to work closely with NINDS on genetics projects,
such as the development of a collaborative and international MS
genetics network. Such a network would facilitate the execution of
small and large-scale studies utilizing both the latest technology to
find genes that may confer susceptibility to MS.
We look forward to the year-end report from NINDS on its commitment
to MS research.
In 2004, we will look to NINDS to establish a Working Group on MS
(as has been done for Parkinson's Disease) to initiate planning to
ensure that MS research is adequately supported throughout NIH and to
collect information on research obstacles.
THE IMPORTANCE OF COLLABORATION
We cannot overemphasize the importance of collaboration. The
National MS Society encourages NIH to increase collaboration across
institutes and to pursue collaborative opportunities with other
organizations.
--Collaboration fosters an interdisciplinary approach to the
investigation of complex biomedical problems.
--Jointly funded research projects significantly leverage limited
resources and advance the research agendas of all involved
parties.
We are pleased to see that NIH Director Zerhouni made collaboration
(both intramural and extramural) one of the pillars of his Roadmap
Initiative--a 3-year plan addressing key research issues throughout
NIH. As we see it, there is no other choice.
To date, the Society has been successful with NIH on jointly
funding a major initiative on gender and immune function. In 2001, the
Society entered into a $20 million collaborative project with NIAID and
other NIH institutes to investigate gender effects on the immune
function, including autoimmunity. This is important because most
autoimmune diseases (including MS) are far more prevalent in women than
men. The Society is co-funding six projects and will contribute up to
$4 million to this project. We would like to engage in other
collaborative projects, especially with NINDS.
The Society asks Congress to urge NIH to increase inter-institute
collaboration as well as collaboration with external public, non-
profit, educational and private sector organizations. Possible areas
for collaborative research could include:
--Neurological repair.--How to effect recovery of tissue (and
function) lost due to neurodegenerative diseases, including MS.
--Neurological degeneration.--Using MS as a model to study
neurological degeneration in diseases such as Alzheimer's
Disease, Parkinson's Disease and MS.
--Genetics.--The role of genetics in susceptibility to, and disease
course of neurological and immunological disorders, including
MS.
--Imaging.--Creation of Magnetic Resonance Imaging (MRI) centers to
study repair, neuroprotection and other clinical issues that
cut across a number of neurological disorders such as stroke,
Alzheimer's Disease, Parkinson's Disease and MS. One possible
eligibility requirement for these centers could be that a
facility have expertise in at least two diseases.
--Pediatric research into diseases that rarely, but sometimes affect
children.
We believe the NIH Director should establish inter-institute,
cross-disease working groups in the above areas to examine and
recommend worthy research topics that will set the stage for future
collaborative projects.
Increased internal and external collaboration, which we hope will
occur at NIH, points to the need for improved research tracking. The
Society also asks that Congress recommend a standard project coding
mechanism across all NIH institutes, so that the true research
investment in various diseases is accurately represented to the public.
OVERALL NIH FUNDING INCREASE FOR FISCAL YEAR 2005
The Society is concerned that NIH may face a second year of overall
low funding increases. Furthermore, in fiscal year 2003 and fiscal year
2004, only bioterrorism research received a healthy increase, with much
smaller increases allocated for disease research. We fear the same may
occur in fiscal year 2005. This is particularly disappointing after the
fiscal years 1999-2003 funding campaign that doubled the NIH budget in
the 5 year period.
--We urge Congress to appropriate a 10 percent fiscal year 2005
funding increase for NIH.
--While there is a need to increase our country's investment in
bioterrorism research, we ask Congress to balance the fiscal
year 2005 NIH appropriation to allow growth across all NIH
institutes and all areas of disease research.
We thank the Subcommittee for this opportunity to comment and
applaud your commitment to advancing the health and well-being of all
Americans through investment in biomedical research.
______
Prepared Statement of the Association of American Universities
Mr. Chairman and members of the subcommittee: The Association of
American Universities, representing 60 prominent research universities
in the United States, appreciates this opportunity to submit testimony
in support of the National Institutes of Health (NIH). Some 85 percent
of the NIH budget is spent on research grants and contracts at higher
education institutions across the United States. NIH research grants
support nearly 40,000 graduate students and post-docs in universities
and help develop a robust and diverse base of scientific talent
critical to the future success of the nation's medical research
efforts. AAU and its member research universities are very aware of the
current restraints on domestic discretionary spending due to proposed
funding increases for defense and homeland security programs, but have
concerns about the long-term vitality of the biomedical research
enterprise if the committee does not recognize that our nation's
investment in NIH is also a top priority. AAU strongly urges the
committee to provide a 10 percent increase in the fiscal year 2005 NIH
budget because today's medical science translates into accelerated
cures for tomorrow.
Past investment in NIH and our national biomedical research
enterprise--the medical science performed by more than 217,000
scientists at more than 2,800 institutions around the country--has led
to an exponential increase in the complexity of medical questions that
can be asked and answered. NIH Director Elias Zerhouni has testified
eloquently before your subcommittee about the health care revolution of
a generation ago: medical research has transformed formerly lethal
diseases into manageable afflictions and has given patients and their
families more years of life. In the past 20 years, some of mankind's
gravest scourges, such as childhood cancers, have been tamed. Deaths
from heart attack and stroke have been cut by hundreds of thousands per
year. HIV/AIDS, which was a death sentence 10 years ago, has become an
onerous but survivable burden for those fortunate enough to live in the
United States and receive triple-drug therapies. Today's biomedical
research enterprise offers the hope of cures that add not just years to
life, but quality of life to those years. AAU endorses the NIH
``Roadmap for Research'' developed by Dr. Zerhouni and his colleagues
as an important framework for making the strategic investments that
will fully capitalize on recent breakthroughs in genomics,
bioinformatics, and molecular medicine. Cures--not just therapies--for
juvenile diabetes, heart disease, osteoporosis, stroke and multiple
cancers are within our grasp, if we can accelerate promising new
research.
NIH-supported scientists have transformed the health and quality of
life of all Americans. To take just one example, more than half of all
cancers treated today will be cured. U.S. medical science is the envy
of the world and the hope of mankind because science--not politics or
ideology--has determined what research is supported. Recent investments
in NIH funded research have:
--Yielded 100 new cancer drugs that are now in clinical trials. NIH-
supported university research, for example, has produced
therapies that target prostate cancer cells and the blood
supply of other solid tumors, leaving healthy tissues
untouched.
--Facilitated clinical trials to further develop at least 11 vaccines
to address the HIV subtypes that together cause most of the HIV
infections around the world. Since 1987, NIH's National
Institute for Allergy and Infectious Diseases (NIAID) has
enrolled more than 3,357 volunteers in 53 Phase I & Phase II
preventive HIV vaccine trials of 28 candidate vaccines.
--Enabled scientists to identify the first drug to have an effect on
both insulin production and insulin action as a potential
therapeutic agent for type 2 diabetes. This example of an NIH
investment in basic research could help the 17 million
Americans who suffer from this disease.
--Revolutionized biomedical science through the sequencing of the
human genome. Researchers now are able to locate, identify, and
describe the function of many human genes. This new knowledge
will lead to genetic tests to diagnose diseases and the
development of drug therapies that are tailored to individual
patients.
AAU urges the committee to provide appropriate funding for NIH or
many promising opportunities will not be funded. If NIH receives
inadequate funding in fiscal year 2005, we will lose significant
opportunities to cure disease and comfort the afflicted. A 10 percent
increase for NIH will:
--Enable faster and cheaper genomic sequencing. Currently it costs
$2-3 billion to sequence an entire genome. An investment of $50
million today will enable the development of new technologies
that will cut the cost of sequencing to $100,000 for a complex
mammal within 5 years and drive the cost of an entire genome to
$1,000 within 10 years.
--Support the new science of proteomics that has enabled physicians
to distinguish among different types of ovarian or breast
cancer tumors and reveal patterns that may have important
clinical implications. Because of previous investments, doctors
can now tailor therapies such as chemotherapy and radiation to
patients based upon their tumor types, dramatically increasing
cure rates and reducing the suffering of women who don't have
to undergo painful therapies needlessly. Today's investment
will drive the cost of diagnosis down to pennies per patient
and further individualize cancer therapies.
--Fund the National Cancer Clinical Trial Database that allows
patients to access information about NCI funded research by
disease type; enables scientists to use recent technological
innovations to produce vast amounts of information about the
genes and proteins active within cancer cells; and allows
cancer funding agencies to coordinate research efforts across
agencies.
--Further reduce the time it takes to develop a vaccine, which has
plummeted from 15 years to fewer than four. For example, two
vaccine candidates for West Nile virus were in clinical trials
within 3 years of West Nile's arrival in the continental United
States. And biomedical researchers were able to take the
knowledge and tools made possible by the NIH doubling to
identify and sequence the SARS virus in a matter of weeks. As
the nation braces for newly emerging infectious diseases such
as bird flu or a bioterror attack, we must continue to develop
new or improved vaccines.
CONCLUSION
As a nation, we enjoy the benefits of a system that recruits
talented individuals and encourages them to compete for research
funding. These individuals undergo a lengthy, rigorous and highly
selective apprenticeship before they apply for their own research
funds. The competition for research support is fierce, and at best only
about 30 percent of the applicants for NIH funds are successful. When
the success rate falls substantially below this level, important
projects are disrupted and promising young people are dissuaded from
research careers. Thus, in order to sustain the high quality of the
biomedical research system, we must continue to provide resources to
encourage the research of our nation's best scientists.
It is imperative that this committee continue its legacy of bi-
partisan support for NIH--the future health of the nation depends of
it. In a year when defense and homeland security are top priorities,
the committee must not allow investments for NIH to erode. The
scientific community is tirelessly working to translate research into
tangible benefits for all Americans. The health and quality of millions
of lives depends on strong support from this committee for the fiscal
year 2005 NIH budget.
Thank you for this opportunity to submit testimony and please let
me know if you have questions.
______
Prepared Statement of the March of Dimes Birth Defects Foundation
The 3 million volunteers and 1,400 staff members of the March of
Dimes appreciate the opportunity to submit the Foundation's federal
funding recommendations for fiscal year 2005. The March of Dimes is a
national voluntary health agency founded in 1938 by President Franklin
D. Roosevelt to prevent polio. Today, the Foundation works to improve
the health of mothers, infants and children by preventing birth defects
and infant mortality through research, community services, education,
and advocacy. The March of Dimes is a unique partnership of scientists,
clinicians, parents, members of the business community, and other
volunteers affiliated with 54 chapters in every state, the District of
Columbia and Puerto Rico.
The volunteers and staff of the March of Dimes are deeply concerned
that for the first time since 1958, the infant mortality rate increased
in 2002. Increases in deaths due to premature birth, birth defects, and
maternal complications during pregnancy are the top reasons for this
increase. In our judgment, the modest funding increases recommended
below would have an immediate and positive impact on this disturbing
trend.
NATIONAL INSTITUTES OF HEALTH
The March of Dimes joins the larger research community in
recommending a 10 percent increase in funding for the National
Institutes of Health (NIH), bringing total federal support to just over
$30 billion. A sustained investment in medical research is vital to
discovering the interventions needed to prevent and treat diseases and
conditions. Because of the profound impact on women and children of the
work supported by the National Institute of Child Health and Human
Development, funding for this Institute is of particular interest to
the March of Dimes.
National Institute for Child Health and Human Development
The mission of the National Institute for Child Health and Human
Development (NICHD) is closely aligned with that of the March of Dimes.
The Foundation recommends an overall increase in funding of 10 percent
for NICHD. With this increase in resources, NICHD could expand research
in several areas that are crucial to improving the health of women and
children. Additional funds would permit expansion of research into
preterm labor and delivery and into the causes of birth defects, and
would enable NICHD to begin implementing the National Children's Study
of environmental and genetic influences on child health and
development.
According to the National Center for Health Statistics, in 2002,
more than 480,000 babies were born prematurely in the United States--1
in 8 births. Since 1981, the preterm birth rate has increased nearly 29
percent. Premature birth accounts for 23 percent of deaths in the first
month of life. Those babies that survive are more likely than full-term
infants to face serious multiple health problems including cerebral
palsy, mental retardation, chronic lung disease, and vision and hearing
loss. Preterm labor can happen to any pregnant woman and the causes of
nearly half of all preterm births are unknown. An analysis of Agency
for Healthcare Research and Quality data conducted by the March of
Dimes Perinatal Data Center estimated that the total national hospital
bill for premature babies was $13.6 billion in 2001. With overall
hospital charges increasing rapidly--13 percent in 2001--the financial
burden of prematurity is expected to worsen until we know how to
prevent preterm births.
The March of Dimes recommends a 10 percent increase for NICHD in
fiscal year 2005 and an increase of at least $50 million over the next
5 years to boost prematurity-related research. This increase should be
devoted to a comprehensive biomedical research program to study preterm
delivery etiology, prevention and treatment regimens.
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
Division of Reproductive Health
The National Center for Chronic Disease Prevention and Health
Promotion, Division of Reproductive Health works to promote optimal
reproductive and infant health, but does not have the resources it
requires to study the growing problem of preterm birth. Therefore, the
March of Dimes recommends a $20 million increase in fiscal year 2005 to
expand research related to preterm birth. The growing problem of
preterm birth requires an expanded, comprehensive prevention research
agenda to identify the causes, risk factors and ways to prevent preterm
birth. In particular, two specific programs should receive additional
funding: (1) the Pregnancy Risk Assessment Monitoring System and (2)
epidemiological research.
The Pregnancy Risk Assessment Monitoring System (PRAMS) is a state-
specific, population based surveillance system designed to identify and
monitor maternal behaviors and experiences before, during, and after
pregnancy. Currently, CDC supports cooperative agreements with 31
states that allow PRAMS to cover about 60 percent of all U.S. births.
Data collected through PRAMS is used by researchers and policy makers
to increase understanding of adverse pregnancy outcomes, to develop and
modify maternal and child health programs, and to incorporate the most
up to date research findings into standards of practice. The March of
Dimes recommends an increase of $5 million to expand PRAMS so that CDC
can develop national estimates on behavioral as well as demographic
risk factors for preterm birth.
Epidemiological research conducted at CDC is vital to reducing the
incidence of preterm labor and delivery. The March of Dimes recommends
an increase of $15 million to expand research on the prevention of
preterm delivery for women at risk, focusing especially on factors
contributing to higher rates of preterm delivery in African-American
women. Increasing CDC's activities related to preterm birth will
improve early detection of women at risk for preterm labor and lead to
new interventions for those at greatest risk.
National Center on Birth Defects and Developmental Disabilities
According to CDC, birth defects are the leading cause of infant
mortality accounting for more than 20 percent of all infant deaths and
are responsible for about 30 percent of all pediatric hospital
admissions. Of the 4 million babies born each year in the United
States, approximately 150,000 are born with one or more serious birth
defects. In addition, birth defects are the fifth-leading cause of
years of potential life lost and contribute substantially to childhood
morbidity and long-term disability. The causes of about 70 percent of
all birth defects are still unknown.
The National Center on Birth Defects and Developmental Disabilities
(NCBDDD) works to prevent birth defects for which causes have already
been identified and conducts research on those defects for which causes
have not yet been found. The March of Dimes urges members of the
Subcommittee to increase funding for the Center to $160 million in
fiscal year 2005 (includes the transfer of Hereditary Blood Disorders
Division). This modest increase will provide the resources necessary to
expand prevention activities where causes are known, and to accelerate
the pace of research where causes have not as yet been identified. An
increase of $15.9 million in funding for prevention, surveillance, and
research activities is vital to making progress in the fight against
birth defects.
Prevention: Folic Acid Education Campaign
The NCBDDD is conducting a national public and health professions
education campaign designed to increase the number of women taking
folic acid daily. According to CDC, each year, an estimated 2,500
babies are born with neural tube defects (NTDs), birth defects of the
brain and spinal cord, including anencephaly and spina bifida. CDC
estimates that up to 70 percent of NTDs could be prevented if all women
of childbearing age consume 400 micrograms of folic acid daily,
beginning before pregnancy. Fortification of the grain supply together
with health provider and consumer education has resulted in a 32
percent decline in the rates of spina bifida. However, the growing
popularity of low-carbohydrate diets has caused an increasing number of
women to reduce or eliminate their daily intake of bread and other
grains. A 2003 Gallup Organization survey conducted for the March of
Dimes found that only 32 percent of women in the United States between
the ages of 18 and 45 take a multivitamin containing folic acid on a
daily basis, up only 4 percent since 1995. When asked what would make
them more likely to take a multivitamin containing folic acid on a
daily basis, 33 percent of women said they would be more likely to do
so on the advice of their doctor or health care provider. Therefore, it
is critical that CDC step up its campaign to educate every woman of
childbearing age about the importance of taking a daily multivitamin
containing folic acid.
To enable CDC to educate more women of child bearing age and their
health providers about the importance of folic acid, the March of Dimes
recommends an appropriation of at least $5 million in fiscal year 2005
for the Folic Acid Education Campaign.
Surveillance: State Cooperative Agreements to Improve Birth
Defects Tracking
NCBDDD funds state initiatives to develop, implement, and/or expand
community-based birth defects tracking systems, programs to prevent
birth defects, and activities to improve access to health services for
infants and children with birth defects. Surveillance forms the
backbone of a vital public health network. CDC is currently supporting
cooperative agreements with 28 states, each funded at an annual level
of between $100,000 and $200,000 for each of 3 years. The March of
Dimes encourages Subcommittee Members to add $3.4 million (a total of
$7.5 million) to state-based birth defects surveillance activities. As
you may know, resources have not been adequate to fund all states
seeking assistance. Additional funding is needed to support creation of
programs where none exist and improvement of programs already receiving
support.
Research: Regional Centers for Birth Defects Research and
Prevention
NCBDDD currently funds 10 regional Centers for Birth Defects
Research and Prevention (each Center receives approximately $900,000
per year) to conduct epidemiological research on birth defects. The
centers are located in Arkansas, California, Georgia, Iowa,
Massachusetts, New Jersey, New York, North Carolina, Texas, and Utah.
These centers obtain data and identify cases for inclusion in the
National Birth Defects Prevention Study, the largest case-control study
of birth defects ever conducted. The centers study the effectiveness of
primary prevention of birth defects, the teratogenicity of various
drugs, the environmental causes of birth defects and the genetic
factors pertaining to susceptibility to environmental causes of birth
defects. For example in response to a scientific study showing a
possible association between the drug loratadine, also sold under the
brand name Claritin, and the occurrence of the birth defect
hypospadias the National Birth Defects Prevention Study conducted a
study that showed no association. This information will be useful to
any woman who takes loratadine and becomes pregnant. The March of Dimes
encourages the Subcommittee to add $10 million (for a total of $17.3
million in funding) to support the important and promising work of the
regional centers.
ADDITIONAL CDC PROGRAMS
National Immunization Program
Immunizations are critical to the health and well-being of
children. CDC's National Immunization Program provides grants to 64
state, local, and territorial public health agencies to reduce the
incidence of disability and death resulting from vaccine preventable
diseases. The March of Dimes urges the Subcommitttee to continue its
longstanding policy of ensuring that federal vaccine programs are
adequately funded to move the nation closer to the goal of vaccinating
at least 90 percent of children and adults. To account for vaccine
price increases, introduction of new vaccines, and to facilitate
implementation of recent Institute of Medicine recommendations, the
March of Dimes recommends an overall increase of $180 million in fiscal
year 2005 for the National Immunization Program.
Polio Eradication
The March of Dimes was founded to find ways of preventing
poliomyelitis. Although success in developing the Salk and Sabin
vaccines enabled the Foundation to shift its focus to a new set of
challenges, we continue to support completing the task of polio
eradication worldwide. Global polio eradication will save lives and
reduce unnecessary health-related costs. The March of Dimes supports a
funding level of $106.4 million for CDC's fiscal year 2005 global polio
eradication activities. With polio epidemics now confined to only 6
countries (Nigeria, India, Pakistan, Niger, Egypt and Afghanistan), it
is important that the U.S. government maintain its commitment to
completion of the worldwide eradication initiative.
National Center for Health Statistics
The Foundation also supports the vital work of the National Center
for Health Statistics (NCHS) which provides information essential for
research and programmatic initiatives. NCHS' surveys to assess the
health status of American's care are critical to many programs and
initiatives. For example, the National Vital Statistics System is a
major source of information on utilization of health services, preterm
births, low birthweight as well as outcomes including birth defects and
infant mortality. Increased funding would allow CDC to modernize this
system using web-based technology that would facilitate rapid
compilation of data and improvement in the accuracy and completeness of
information obtained from health professionals and facilities. This
information is needed to track trends in birth outcomes and to support
birth defects registries. Additional resources would also enable CDC to
continue the National Survey of Family Growth which provides essential
information on factors affecting birth outcomes.
HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)
Newborn Screening
Newborn screening is a public health activity used to identify
genetic, metabolic, hormonal and/or functional conditions in newborns.
Many such disorders, if left untreated, can cause disability, mental
retardation, and even death. Although nearly all babies born in the
United States undergo newborn screening tests for some genetic birth
defects, the number and quality of these tests varies from state to
state. The March of Dimes recommends that every baby born in the United
States receive, at a minimum, screening for a core set of nine
metabolic disorders as well as hearing deficiencies.
In fiscal year 2004, the Congress provided first-time funding for
implementation of Title XXVI of the Children's Health Act of 2000. This
program is designed to strengthen state newborn screening programs; to
improve states' ability to develop, evaluate, and acquire innovative
testing technologies; and to establish and improve programs to provide
screening, counseling, testing and special services for newborns and
children at risk for heritable disorders. The March of Dimes proposes
an appropriation of $25 million to support HRSA's work with states to
expand the heritable disorders (newborn screening) program authorized
through Title XXVI.
Maternal and Child Health Block Grant
Title V of the Social Security Act, the Maternal and Child Health
(MCH) block grant, funds community-based services such as home visiting
and respite care for children with special health care needs. MCH
complements Medicaid and the State Children's Health Insurance Program
by providing ``wrap-around'' services and other needed health services.
The March of Dimes recommends fully funding the block grant at the
authorized level of $850 million and notes that in order to hold states
harmless an appropriation of $807 million is required. Additional
funding would enable states to expand critical services such as
prenatal and infancy home visitation programs, strategy that helps
improve birth outcomes. According to the Maternal and Child Health
Bureau, 900,000 children with special health care needs use MCH
services. These children would also benefit as increased resources
would enable states to raise spending limits for home visits respite
care, physical and occupational therapy, durable medical equipment, and
other support services.
Consolidated Health Centers
Consolidated (Community) Health Centers are an important source of
obstetric and pediatric care for more than 13 million individuals, 40
percent of whom are uninsured. The Foundation recommends new funding
sufficient to increase the number of centers and to improve the scope
of perinatal services provided. Adding funds to this program would be
consistent with the President's 5-year plan to create and expand health
center sites in 1,200 communities and to increase the number of
patients served annually to more than 16 million.
Thank you for the opportunity to testify on the federally supported
programs of highest priority to the March of Dimes. The Foundation's
staff and volunteers look forward to working with Members of the
Subcommittee to improve the health of mothers, infants and children.
MARCH OF DIMES FISCAL YEAR 2005 FEDERAL FUNDING PRIORITIES
[In millions of dollars]
------------------------------------------------------------------------
Fiscal year
----------------------------
Program 2005 March of
2004 Dimes
funding recommendation
------------------------------------------------------------------------
National Institutes of Health (Total)...... 27,878.0 30,666.0
National Institute of Child Health & 1,242.0 1,366.0
Human Development.....................
National Human Genome Research 479.0 527.0
Institute.............................
National Center on Minority Health and 192.0 211.0
Disparities...........................
Centers for Disease Control and Prevention 6,972.0 8,100.0
(Total)...................................
Center on Birth Defects and 113.0 \1\ 160.0
Developmental Disabilities............
Regional Centers for Birth Defects 7.3 17.3
Research & Prevention.............
State Cooperative Agreements to 4.1 7.5
Improve Birth Defects Tracking....
Folic Acid Education Campaign...... 2.5 5.0
Immunization........................... 644.0 824.0
Polio Eradication.................. 106.4 106.4
Safe Motherhood/Infant Health (NCCDPHP) 54.0 74.0
Pregnancy Risk Assessment 7.1 12.0
Monitoring System.................
Prevention Research (Preterm Birth) 1.3 16.3
National Center for Health Statistics.. 128.0 181.0
Health Resources and Services 6,600.0 8,000.0
Administration (Total)....................
Maternal and Child Health Block Grant.. 730.0 850.0
Newborn Screening.................. 2.0 25.0
Newborn Hearing Screening.............. 10.0 10.0
Consolidated (Community) Health Centers 1,617.0 1,867.0
Healthy Start.......................... 98.0 98.0
Agency for Healthcare Research and Quality. 304.0 390.0
------------------------------------------------------------------------
\1\ Fiscal year 2005 funding recommendation includes $22 million
transfer of the Hereditary Blood Disorders Division and $25 million in
new funding.
______
Prepared Statement of the NephCure Foundation
SUMMARY OF RECOMMENDATIONS FOR FISCAL YEAR 2005
--A 10 percent increase for the National Institutes of Health and the
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK).
--Continue to expand the NIDDK Nephrotic Syndrome (NS)/Focal
Segmental Glomerulosclerosis (FSGS) research portfolio by
aggressively supporting grant proposals in this area and
encouraging the National Center for Minority Health and Health
Disparities (NCMHD) to initiate studies into the incidence/
cause of NS/FSGS in the African-American population.
--The NephCure Foundation enthusiastically supports the Scientific
Conference/Workshop being sponsored by the National Institute
of Diabetes & Digestive & Kidney Diseases (NIDDK). The workshop
will take place early in 2005 and will examine areas of promise
surrounding glomerular disease and will develop a future agenda
for Focal Segmental Glomerulosclerosis (FSGS) research.
--The NephCure Foundation encourages follow up to the 2005 scientific
workshop in hopes that it will initiate grant proposals focused
on achieving the goals and opportunities developed by the
workshop.
Mr. Chairman, and members of the subcommittee, I am pleased to
present testimony on behalf of the NephCure Foundation (NCF), a non-
profit organization driven by a blue-ribbon panel of respected medical
experts and a dedicated band of patients and families working for a
common goal--to save kidneys and lives.
I am Ed Hearn, former Major League Baseball Player for the Kansas
City Royals. My career as a professional athlete came to an abrupt end
in 1988, when I was diagnosed with Focal Segmental Glomerulosclerosis
(FSGS), a debilitating and degenerative kidney disease. Today, after
two life-changing kidney transplants, a successful bout against cancer,
the aid of a breathing machine each night, a $3,000 IV once a month,
and $40,000 of medication per year, I live to tell my story and to
speak for those suffering from FSGS. My hope is that we can find the
means to prevent this life-threatening disease from affecting our youth
and from jeopardizing the normalcy of their lives as it has mine and
many others. I remain hopeful that a cure for FSGS will be discovered,
but until then, we must focus on prevention.
TREATMENT TRIALS BEGINNING, BUT NO CURE IN SIGHT
Mr. Chairman, FSGS is one of a cluster of glomerular diseases that
attack the one million tiny filtering units contained in each human
kidney. These filters are called nephrons and the diseases attack the
portion of the nephron called the glomerulus, scarring and often
destroying the irreplaceable filters. Scientists do not know why
glomerular injury occurs and they are not sure how to stop its
inevitable destruction of the kidney.
When I was a teenager, doctors found protein in my urine and told
me that some day I might have kidney trouble. I thought ``Fine, maybe
I'll have to deal with that when I'm an old man down the road.'' Some
day happened much sooner than anyone expected. I believe that because I
was a highly-conditioned athlete--and catchers are more conditioned
than most--my body initially masked the symptoms of FSGS.
My first kidney transplant lasted more than 7 years until the FSGS
returned. I received a second kidney from my aunt in 2000, but my body
rejected it almost immediately, and I received a third transplant in
May 2002. My story is not unique; there are thousands of other people
in this country who have had their lives disrupted due to the sudden
onset of FSGS.
We are extremely thankful that an NIDDK-funded clinical trial began
this year to study the efficacy of the current treatments for FSGS, and
that ancillary studies are underway to examine tissue samples of
injured glomerulus. However, these clinical trials hold no particular
hope for patients who suffer from FSGS.
As children are most often affected by this disease, there are
thousands of young people who are in a race against time, hoping for a
treatment that will save their lives. The NephCure Foundation today
raises its voice to speak for them all, asking you to take specific
actions that will aid our quest to find the cause and the cure of NS/
FSGS.
First and foremost, we support a 10 percent increase for the
National Institutes of Health and the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK).
TOO LITTLE DATA ABOUT A GROWING PROBLEM
When glomerular disease strikes, the resulting Nephrotic Syndrome
causes loss of protein in the urine and symptoms such as edema, a
swelling that often appears first in the face. For example, many
physicians mistake children's puffy eyelids as an allergy symptom.
Stories of similar misdiagnoses are common at our Foundation. With
experts projecting a substantial increase in Nephrotic Syndrome in the
coming years, there is a clear need to educate pediatricians and family
physicians about glomerular disease and its symptoms.
The NephCure Foundation has numerous education programs underway,
including patient education seminars; the most recent of which took
place in May 2003. News of our most recent activities can be found on
our web site at www.nephcure.org. However, our efforts alone are not
enough.
NIDDK launched a major federal outreach program early in 2002--the
National Kidney Disease Education Program--we seek your support in
urging NIDDK to assure that glomerular disease receives high visibility
in this important program.
GLOMERULAR DISEASE STRIKES MINORITY POPULATIONS
Nephrologists tell us that glomerular diseases such as FSGS affect
a disproportionate number of African-Americans and, according to NIDDK,
``the worst prognosis is observed in African-American children.''
NephCure officials have described this situation in a meeting with Dr.
John Ruffin, director of the National Center for Minority Health and
Health Disparities (NCMHD).
As the NCMHD becomes fully operational and plans programs, our
Foundation will continue to work with the Center to encourage the
creation of programs to study the high incidence of glomerular disease
within the African-American population.
We ask the Committee to join with us in expanding the NS/FSGS
research portfolio by requesting that the National Center for Minority
Health and Health Disparities seize the opportunity to establish
research into the phenomenon of glomerular disease within the African
American community.
MORE BASIC SCIENCE IS NEEDED
The current FSGS clinical trials which follow an estimated 400
patients over a 3-year period, are limited, according to the RFA, to
examining the ``impact of immunomodulatory therapy on proteinuria.''
While the trials may lead to safer or more efficient care for children
with FSGS, no one is suggesting that they will bring us closer to
finding the cause and cure. Science has yet to prove that FSGS is an
immune-mediated disease.
Scientists tell us that much more needs to be done in the area of
basic science, beginning with collection of tissue and fluid samples
from a large number of patients on which years of important scientific
research can be founded. NephCure is collaborating with the NIH in a
major way to work for such progress.
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) has agreed to match, dollar-for-dollar, funds raised
by NephCure that will allow researchers to obtain DNA samples from
hundreds of FSGS patients in upcoming clinical trials. The NIDDK will
match up to $300,000 raised by NephCure for a combined total of
$600,000. These trials are an ancillary study in conjunction with the
first-ever national medication trials of FSGS treatment that may
possibly lead to better understanding of the more common Nephrotic
Syndrome, which can be a precursor to FSGS.
We enthusiastically support NIDDK in sponsoring a scientific
workshop/conference to take place early in 2005, with the intent to
review the most promising existing science in glomerular disease, and
focus on methods of translating this scientific information into
improved patient care. This goal is consistent with the NIH Roadmap to
Research initiative developed by NIH Director, Dr. Elias Zerhouni.
We sincerely believe that the workshop will expose opportunities
and challenges in glomerular disease research, and evaluate the
resources needed to carry out these opportunities and challenges. The
workshop/conference will lend hope to the thousands of young people
whose kidneys and lives are threatened by this terrible disease, and
give meaning and honor to their heroic stories.
The NephCure Foundation encourages follow up to the scientific
workshop/conference in hopes that it will generate grant proposals
focused on achieving the research goals and opportunities developed by
the workshop.
We anticipate the potential for a Program Announcement and the
potential for a Special Emphasis Program Announcement resulting from
the conference or some other traditional mechanism to generate grant
proposals. These mechanisms to encourage investigator initiated grant
proposals should help to continue to expand the NS/FSGS portfolio at
NIH.
Mr. Chairman, as you know, patient support and advocacy groups such
as the NephCure Foundation work closely with medical research
organizations. They share a mutual understanding that unless major
research efforts are undertaken, advances and improvements in the
health of patients will not occur. Every year, the NephCure Foundation
participates in advocating increased funding for the NIH and NIDDK. We
want to reiterate how deeply grateful we are for your leadership and
that of the subcommittee on medical research matters, which means so
much for the health of the people in our nation.
I will be pleased to answer any questions you may have.
______
Prepared Statement of the Digestive Disease National Coalition
SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS
--Provide increased funding for the National Institutes of Health
(NIH) at 10 percent for fiscal year 2005. Increase funding for
the National Cancer Institute (NCI), the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) and the
National Institute of Allergy and Infectious Diseases by 10
percent for fiscal year 2005.
--Continue focus on digestive disease research and education at NIH,
including the areas of Inflammatory Bowel Disease (IBD),
Hepatitis and other liver diseases, Irritable Bowel Syndrome
(IBS), Colorectal Cancer, Endoscopic Research, Pancreatic
Cancer, Celiac Disease, and Hemochromatosis.
--$25 million for the Centers for Disease Control and Prevention's
(CDC) Hepatitis Prevention and Control activities.
--$30 million for the Centers for Disease Control and Prevention's
(CDC) National Viral Hepatitis Roundtable Program
Chairman Specter, thank you for the opportunity to again submit
testimony to the Subcommittee. Founded in 1978, the Digestive Disease
National Coalition (DDNC) is a voluntary health organization comprised
of 25 professional societies and patient organizations concerned with
the many diseases of the digestive tract. The Coalition has as its goal
a desire to improve the health and the quality of life of the millions
of Americans suffering from both acute and chronic digestive diseases.
The DDNC promotes a strong federal investment in digestive disease
research, patient care, disease prevention, and public awareness. The
DDNC is a broad coalition of groups representing disorders such as
Inflammatory Bowel Disease (IBD), Hepatitis and other liver diseases,
Irritable Bowel Syndrome (IBS), Pancreatic Cancer, Ulcers, Pediatric
and Adult Gastroesophageal Reflux Disease, Colorectal Cancer, Celiac
Disease, and Hemochromatosis.
Mr. Chairman, the social and economic impact of digestive disease
is enormous and difficult to grasp. Digestive disorders afflict
approximately 65 million Americans. This results in 50 million visits
to physicians, over 10 million hospitalizations, collectively 230
million days of restricted activity. The total cost associated with
digestive diseases has been conservatively estimated at $60 billion a
year.
The DDNC would like to thank the subcommittee for its past support
of digestive disease research and prevention programs at the National
Institutes of Health (NIH) and the Centers for Disease Control and
Prevention (CDC). With respect to the coming fiscal year the DDNC is
recommending an increase of 10 percent to $30 billion for the National
Institutes of Health (NIH) and all of its Institutes. Specifically the
DDNC recommends that the National Cancer Institute (NCI), the National
Institute of Diabetes and Digestive and Kidney Disease (NIDDK), and the
National Institute of Allergy and Infectious Diseases (NIAID be given
$5.25 billion, $2.01 billion, and $4.77 billion respectively. We at the
DDNC respectfully request that any increase for NIH does not come at
the expense of other Public Health Service agencies.
With the historic doubling of the budget for NIH completed and the
challenging budgetary constraints the Subcommittee currently operates
under, the DDNC would like to highlight the research being accomplished
by NIDDK which warrants the increase for NIH.
INFLAMMATORY BOWEL DISEASE
In the United States today about 1 million people suffer from
Crohn's disease and ulcerative colitis, collectively known as
Inflammatory Bowel Disease (IBD). These are serious diseases that
affect the gastrointestinal tract causing bleeding, diarrhea, abdominal
pain, and fever. Complications arising from IBD can include anemia,
ulcers of the skin, eye disease, colon cancer, liver disease,
arthritis, and osteoporosis. Crohn's disease and ulcerative colitis are
not usually fatal but can be devastating. The cause of IBD is still
unknown, but research has led to great breakthroughs in therapy.
In recent years researchers have made significant progress in the
fight against IBD. In 1998, the FDA approved the first drug ever
specifically to fight Crohn's disease, a remarkable milestone. The DDNC
encourages the subcommittee to continue its support of IBD research at
NIDDK and NIAID at a level commensurate with the overall increase for
each institute. The DDNC would like to applaud the NIDDK for its strong
commitment to IBD research through the Inflammatory Bowel Disease
Genetics Research Consortium. The DDNC urges the Consortium will
continue its work in IBD research. The DDNC would also commend NIDDK
for organizing and hosting the upcoming meeting entitled: ``Research on
Inflammatory Bowel Disease'', later this month.
Given the recent advancements in treatment for these diseases and
the increased risk that IBD patients have for developing colorectal
cancer, the DDNC strongly believes that generating improved
epidemiological information on the IBD population is essential if we
are to provide patients with the best possible care. Therefore the DDNC
and its member organization the Crohn's and Colitis Foundation of
America encourage the CDC to initiate a nationwide IBD surveillance and
epidemiological program in fiscal year 2005.
HEPATITIS C: A LOOMING THREAT TO HEALTH
It is estimated that there are over 4 million Americans who have
been infected with Hepatitis C of which over 2.7 million remain
chronically infected. About 10,000 die each year and the Centers for
Disease Control and Prevention (CDC) estimates that the death rate will
more than triple by 2010 unless there is additional research,
education, and more effective treatments and public health
interventions. Hepatitis C infection is the largest single cause for
liver transplantation and one of the principal causes of liver cancer
and cirrhosis. There is currently no vaccine for hepatitis C, and
treatment has limited success, making the infection among the most
costly diseases in terms of health care costs, lost wages, and reduced
productivity. Patients who are older at the time of infection, those
who continually ingest alcohol, and those co-infected with HIV
demonstrate accelerated progression to more advanced liver disease.
The DDNC applauds all the work NIH and CDC have accomplished over
the past year in the areas of hepatitis and liver disease. An example
of this commitment has been the convening of the second National
Institutes of Health Management of Hepatitis C Consensus Development
Conference, which occurred in June 2002. The Conference made 17
specific and high priority research recommendations that need to be
pursued to develop better treatments and a cure for hepatitis. The DDNC
urges that these recommendations be funded in fiscal year 2005. The
DDNC also commends NIDDK for the establishment of the Biliary Atresia
Research Consortium and the Adult-to-Adult Living Donor Liver
Transplant Cohort Study. The convening of conferences on Hepatitis C
and Renal Disease and Hepatitis C in Prisons, plus the New Direction
for Therapy of Primary Biliary Cirrhosis are just some more positive
examples of the work NIDDK has undertaken to combat hepatitis and liver
disease. The DDNC urges NIDDK to continue support research in this
area.
The DDNC supports $30 million for the CDC's Hepatitis Prevention
and Control activities. The hepatitis division at CDC supports the
hepatitis C prevention strategy and other cooperative nationwide
activities aimed at prevention and awareness of hepatitis A, B, and C.
The DDNC also urges the CDC's leadership and support for the National
Viral Hepatitis Roundtable to establish a comprehensive approach among
all stakeholders for viral hepatitis prevention, education, strategic
coordination, and advocacy.
COLORECTAL CANCER PREVENTION
Colorectal cancer is the third most commonly diagnosed cancer for
both men and woman in the United States and the second leading cause of
cancer-related deaths. Colorectal cancer affects men and women equally.
Although colorectal cancer is preventable and curable when polyps are
detected early, a General Accounting Office report issued in March 2000
documented that less than 10 percent of Medicare beneficiaries have
been screened for colorectal cancer. This report revealed a tremendous
need to inform the public about the availability of screening and
educate health care providers about colorectal cancer screening
guidelines. In 2003, the New York City Department of Health has
recommended colonoscopy for everyone over age 50 to prevent colorectal
cancer.
The DDNC recommends a funding level of $25 million for the CDC's
Colorectal Cancer Screening and Prevention Program. This important
program supports enhanced colorectal screening and public awareness
activities throughout the United States. The DDNC also supports the
continued development of the CDC-supported National Colorectal Cancer
Roundtable, which provides a forum among organizations concerned with
colorectal cancer to develop and implement consistent prevention,
screening, and awareness strategies.
PANCREATIC CANCER
In 2002, an estimated 28,300 people in the United States were found
to have pancreatic cancer and approximately 28,200 died from the
disease. Pancreatic cancer is the fifth leading cause of cancer death
in men and women. Only 2 out of 10 patients will live 1 year after the
cancer is found and only a very few will survive after 5 years.
Although we do not know exactly what causes pancreatic cancer, several
risk factors linked to the disease have been identified:
(1) Age.--Most people are over 60 years old when the cancer is
found;
(2) Sex.--Men have pancreatic cancer more often than women;
(3) Race.--African Americans are more likely to develop pancreatic
cancer than are white or Asian Americans;
(4) Smoking
(5) Diet.--Increased red meats and fats; and
(6) Diabetes
The National Cancer Institute (NCI) has established a Pancreatic
Cancer Progress Review Group charged with developing a detailed
research agenda for the disease. The DDNC commends NIDDK for the
establishment in 2002 on an initiative entitled: Liver, Pancreas, and
Gastrointestinal Cell Genome Anatomy Project. The DDNC hopes this new
initiative will call more attention and greater resources to the
diseases of the Pancreas. The DDNC encourages the Subcommittee to
provide an increase for pancreatic cancer research at a level
commensurate with the overall percentage increase for NCI and NIDDK.
IRRITABLE BOWEL SYNDROME (IBS)
IBS is a disorder that affects an estimated 35 million Americans.
The medical community has been slow in recognizing IBS as a legitimate
disease and the burden of illness associated with it. Patients often
see several doctors before they are given an accurate diagnosis. Once a
diagnosis of IBS is made, medical treatment is limited because the
medical community still does not understand the pathophysiology of the
underlying conditions.
Living with IBS is a challenge, patients face a life of learning to
manage a chronic illness that is accompanied by pain and unrelenting
gastrointestinal symptoms. Trying to learn how to manage the symptoms
is not easy. There is a loss of spontaneity when symptoms may intrude
at any time. IBS is an unpredictable and fickle disease. A patient can
wake up in the morning feeling fine and within a short time encounter
abdominal cramping to the point of being doubled over in pain and
unable to function.
The unpredictable bowel symptoms may make it next to impossible to
leave your home. It is difficult to ease the pain than may repeatedly
occur periodically throughout the day. A patient can become reluctant
to eat for fear that just eating a meal will trigger symptoms all over
again. IBS has a broad and significant impact on a person's quality of
life. It strikes individuals from all walks of life and results in a
significant toll of human suffering and disability.
While there is much we don't understand about the causes and
treatment of IBS, we do know that IBS is a chronic complex of systems
affecting as many as one in five adults. In addition:
--It is reported more by women than men;
--It is the most common gastrointestinal diagnosis among
gastroenterology practices in the United States;
--It is a leading cause of worker absenteeism in the United States;
and
--It costs the U.S. Health Care System an estimated $8 billion
annually.
Mr. Chairman, much more can still be done to address the needs of
the nearly 35 million Americans suffering from irritable bowel syndrome
and other functional gastrointestinal disorders.
CELIAC DISEASE
Celiac Disease is a life-long condition in which the body develops
an allergy to gluten, a protein found in wheat, barley, and rye, which
can result in damage to the small intestine. Celiac disease affects as
many as 2 million Americans. Onset of the disease can occur at any age.
The common symptoms of Celiac Disease include fatigue, anemia, chronic
diarrhea or constipation, weight loss, and bone pain. The only
treatment for celiac disease is strict adherence to a gluten-free diet.
Undiagnosed and untreated celiac disease can lead to other disorders
such as osteoporosis, infertility, neurological conditions, and in rare
cases cancer. Persons with Celiac Disease often have other associated
autoimmune disorders as well.
The DDNC along with our Celiac Disease applauds the NIDDK for
organizing and hosting the upcoming meeting entitled ``Consensus
Development Conference on Celiac Disease.'' The DDNC urges the
Subcommittee to recommend more research, medical education, and public
awareness around Celiac Disease.
The DDNC understand the challenging budgetary constraints and times
we live in that is subcommittee is operating under, yet we hope you
will carefully consider the tremendous benefits to be gained by
supporting a strong research and education program at NIH and CDC.
Millions of Americans are pinning their hopes for a better life, or
even life itself, on digestive disease research conducted through the
National Institutes of Health.
Mr. Chairman, on behalf of the millions of digestive disease
sufferers, we appreciate your consideration of the views of the
Digestive Disease National Coalition. We look forward to working with
you and your staff.
Digestive Disease National Coalition
The Digestive Disease National Coalition was founded 25 years ago.
Since its inception, the goals of the coalition have remained the same:
to work cooperatively to improve access to and the quality of digestive
disease health care in order to promote the best possible medical
outcome and quality of life for current and future patients with
digestive diseases.
______
Prepared Statement of the First Candle/Sudden Infant Death Syndrome
Alliance
SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS
--Provide a 10 percent increase for fiscal year 2005 to the National
Institutes of Health (NIH) and a proportional increase of 10
percent to the individual institutes and centers, specifically,
the National Institute of Child Health and Human Development
(NICHD).
--Transition from NICHD's successful SIDS 5-year research plan to a
more comprehensive plan focusing on SIDS, stillbirth, and
miscarriage.
--Continue to fund the SIDS and Other Infant Death Program Support
Center at the Maternal and Child Health Bureau, within the
Health Resources and Services Administration (HRSA).
--Fund 3 SIDS death scene protocol demonstration projects through the
Centers for Disease Control and Prevention (CDC) in rural,
urban, and suburban settings to provide a nation-wide protocol
for dealing with SIDS death scenes.
Mr. Chairman and members of the Subcommittee, thank you for again
allowing First Candle/SIDS Alliance the opportunity to submit testimony
to this Subcommittee. First Candle is a national voluntary health
organization uniting parents, caregivers, and researchers nationwide
with government, business, and community service groups. Our mission is
to promote infant health and survival during the prenatal period
through 2 years of age through advocacy, education, and research, while
at the same time providing compassionate grief support to those
affected by an infant death.
Mr. Chairman, we still need your help, commitment, and support to
help solve the mysteries of Sudden Infant Death Syndrome (SIDS) and
stillbirth and ensure healthy pregnancies for all women.
Despite the fact that SIDS cases have been documented for years,
organized scientific research into SIDS only began in the mid 1970's.
In the three decades since, scientists are now beginning to make
significant progress in unraveling this enigma of SIDS, which robs
families of their infant children. As an example of this progress, we
now know that in many SIDS related deaths there is an abnormality or
under-development in a region of the infant's brain, which is thought
to control the heart and lung functions. In these cases, the
irregularity may hamper normal respiratory activity. While this may not
be the sole cause of SIDS, it could contribute to a larger respiratory
problem leading to death when combined with other circumstances.
As a direct result of SIDS research and the ``Back to Sleep''
educational and awareness campaign on infant sleep positioning, SIDS
deaths have been reduced by 50 percent since 1992, leading to the
greatest decline in infant mortality rates in over 20 years.
Despite this exceptional news, our research and educational
campaign is far from finished. There are still more than 2,500 SIDS
deaths in the United States each year and SIDS continues to be the
number one cause of death for children between 1 month and 1 year of
age. SIDS is a major component of the United States infant mortality
rate. In spite of these facts, we still do not yet understand the
causes of SIDS nor do we possess any guaranteed method for its
prevention.
Stillbirth is the death of an infant in-utero past 20 completed
gestational weeks. The majority of these deaths occur at or near full-
term; therefore, otherwise healthy babies die shortly before or during
birth. There are more than 26,000 parents in the United States alone
that experience a stillbirth annually, and it is estimated that nearly
two-thirds of all stillbirth deaths remain unexplained. This translates
to more than 70 stillborn babies delivered in the United States each
day. More than half of these deaths are at 28 weeks or more gestation,
and one in five full term babies are stillborn.
In spite of these statistics and the impact stillbirth has on
families, little attention has been paid to the problem. There is a
dire need for increased public awareness and federal funding to support
stillbirth research and education programs. In 2003, NICHD committed $3
million to conduct five projects, which focus on central data
collection and research protocols for stillbirth deaths. First Candle
urges the Subcommittee to support continued funding for stillbirth
research at NICHD.
First Candle is grateful for the Subcommittee's past support of
SIDS activities, especially the support of NICHD. We urge you to again
provide the additional funding necessary for the third Five-Year SIDS
Research Plan to ensure that NICHD can continue to address critical
SIDS research initiatives and expand on their recent funding for
stillbirth research. Specifically, First Candle is supporting a funding
increase of 10 percent for NIH overall, and a 10 percent increase for
NICHD. We respectfully ask that the increases for NIH do not come at
the expense of other Public Health Service agencies. Further research
is essential to find the reasons for and means of preventing the
tragedies of SIDS and stillbirth.
First Candle urges the Subcommittee to support infant death
educational, awareness, and counseling activities that take place at
the MCHB, and the death scene investigation protocol demonstration
projects at the CDC. These programs are a vital companion to the
research conducted at NICHD. Without prevention, awareness, counseling,
and standardized investigation procedures, competent scientific
research does not translate into meaningful advances for parents and
families.
HIGHLIGHTS OF FEDERALLY FUNDED ACTIVITIES
National Institute of Child Health and Human Development (NICHD)
The mechanism of SIDS is still unknown; there are no clinical or
biologic tests to identify a newborn at high risk of succumbing to
SIDS; and more work is needed to increase the implementation of ``Back
to Sleep'' among all caregivers and in communities with high rates of
infant death. To address and focus its efforts on these challenges,
NICHD has developed and implemented three SIDS Five-Year Research
Plans. Now that NICHD is focusing more globally on infant health, First
Candle is encouraging the institute to transition from their successful
SIDS 5-year research plan to a more comprehensive plan focusing on
SIDS, stillbirth, and miscarriage.
Maternal and Child Health Bureau (MCHB)
First Candle has entered into a collaborative effort with MCHB to
kickoff the ``Healthy Child Care America Back to Sleep Campaign''. This
initiative builds on the success of the ``Healthy Child Care America''
and ``Back to Sleep'' campaigns to unite child care, health, and SIDS
prevention partners across the country to reduce the number of SIDS-
related deaths in child care settings.
The MCHB continues to support a number of SIDS and Other Infant
Death related services and programs, including the following
activities:
--National SIDS Resource Center, a major source of current
information about SIDS.
--Maternal and Child Health Service Block Grant (MCH), which grants
funds to states providing a range of services to SIDS families.
Block grant funds support activities like: contact families
immediately after death, discussion of autopsy results with the
family, and support and counseling through the first year of
bereavement. Unfortunately, in many jurisdictions across the
country, funds for these services have been decreased or
eliminated due to budgetary difficulties.
--Field training and curriculum to health care providers for case
management of families who have experienced an infant death,
and the development of model programs, particularly for the
underserved and minorities. Demonstration grants have been
established and are continuing in four states to target
services for specific populations: California, Massachusetts,
Missouri, and New York.
--National SIDS & Infant Death Program Support Center to address SIDS
service issues at the federal level on an ongoing basis. First
Candle runs this center, which opened in 1999, and has
experienced notable success. The support center is working to
expand bereavement services to family members of those who
experience stillbirth and miscarriage.
Centers for Disease Control and Prevention (CDC)
To develop a better statistical figure on SIDS cases, Congress
recommended in 1993 the establishment of a standard death scene
protocol to offset discrepancies on unexplained infant deaths between
states. It was hoped that this protocol would be adopted by states not
only for statistical measure, but to help avoid what can become awkward
and emotionally charged misunderstandings at the death scene. In 1996,
CDC published the protocol, and since that time several states have
adopted the standard. It is First Candle's long term goal to ensure
that all states fully adopt and implement the protocol. To help realize
this goal, First Candle would like Congress to appropriate funds for
CDC to heed Congress' recommendations for the past several years and
implement the demonstration projects that follow these guidelines in
several community settings nationwide. We recommend a demonstration
project in each of the following, a rural community setting, an urban
community setting, and a suburban community setting. We would also
encourage CDC to implement a nationwide survey to measure how many
locales have already implemented the protocol independently and to
analyze the results thus far.
In conclusion, we are all too painfully aware that SIDS has
historically been a mystery, leaving in its wake devastated families
and bewildered physicians. Not only have there been no answers on the
cause of SIDS, but there have been no answers on how to effectively
prevent its occurrence. Today we are beginning to find some of the
answers on cause and prevention, and therefore reduce the risk of SIDS.
Because of the ``unknown'', however, babies are still vulnerable even
when parents and caregivers take the cautionary steps to prevent SIDS
deaths. This tragedy will continue if research efforts are stalled or
halted, especially when we are at the point where so much progress has
been made. Now is the time for a re-energized effort against this
tragic syndrome. Staggering statistics and the critical need for public
awareness and research into the scope and causes of stillbirth has led
to the joining together of parents and professionals to formally
advocate for research into the causes and prevention of pre-term infant
death. Now is the time for research into the horrible tragedy of
stillbirth that too frequently becomes the outcome of a seemingly
normal pregnancy.
On behalf of the thousands of families who have been devastated by
the loss of a baby to SIDS, stillbirth, or miscarriage and the millions
of concerned and frightened parents, I ask for your support, and thank
you again for allowing First Candle to submit this testimony.
First Candle/Sudden Infant Death Syndrome Alliance
First Candle/SIDS Alliance is an organization of parents and
friends of SIDS, Stillbirth and Other Infant Death victims along with
medical, business, and civic groups who are concerned about the health
our nation's children. The Alliance is engaged in ongoing efforts to
expand its scientific program, strengthen services for families, and
provide public education and advocacy opportunities. An important goal
is to improve community understanding and elevate SIDS, Stillbirth and
Other Infant Death to the level of societal concern appropriate to one
of our nation's major causes of infant mortality.
______
Prepared Statement of the National Sleep Foundation
SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS
--Provide a 10 percent increase for fiscal year 2005 to the National
Institutes of Health (NIH) and a proportional increase of 10
percent to the individual institutes and centers, specifically,
the National Heart, Lung, and Blood Institute (NHLBI).
--Urge the National Center on Sleep Disorders Research (NCSDR) to
partner with other federal agencies, such as the Centers for
Disease Control and Prevention (CDC), and voluntary health
organizations, such as the National Sleep Foundation (NSF), to
develop a collaborative sleep education and public awareness
initiative.
Mr. Chairman and members of the Subcommittee, thank you for
allowing me present testimony today on behalf of the National Sleep
Foundation or NSF. I am Dr. James Walsh, Chairman of the Board of
Directors of the National Sleep Foundation, Executive Director of the
Sleep Medicine and Research Center affiliated with St. John's Mercy and
St. Luke's Hospitals, and Clinical Professor of Psychiatry at St. Louis
University. The National Sleep Foundation is an independent, non-profit
organization whose mission is to enhance public awareness about the
need for sufficient restorative sleep, to increase the detection and
treatment of sleep disorders, to foster sleep-related programs and
policy for the betterment of public health, and to promote sleep
research. We work with thousands of sleep medicine and other health
care professionals, researchers, patients, drowsy driving victims
throughout the country, and collaborate with many government and
private organizations with the goal of preventing health and safety
problems related to sleep deprivation and untreated sleep disorders.
Sleep problems, whether in the form of medical disorders, or
related to work schedules and a 24/7 lifestyle, are ubiquitous in our
society. At least 40 million Americans suffer from sleep disorders; yet
more than 60 percent of adults have never been asked about the quality
of their sleep by a physician, and fewer than 20 percent have ever
initiated such a discussion. Millions of individuals struggle to stay
alert at school, on the job, and on the road. The latest estimates from
the National Highway Transportation Safety Administration and the
Federal Motor Carriers Safety Administration implicate fatigue and
sleepiness in 1.1 million crashes annually. A recent study in Sweden
showed that sleep disturbances are the second greatest risk factor for
fatal accidents at work. Sleep apnea, a sleep-related breathing
disorder which affects at least 5 percent of adult Americans, is
closely related to some of America's most pressing health problems,
such as obesity, hypertension, heart failure, and diabetes. Chronic
insomnia, experienced by 10 percent of our population is a strong risk
factor for depression and other widespread mental health conditions.
Sleep disorders, sleep deprivation, and excessive daytime sleepiness
add approximately $15 billion to our national health care bill each
year. The National Center on Sleep Disorders Research estimates that by
the year 2050, sleep problems will affect as many as 100 million
Americans.
Sleep science has clearly demonstrated the importance of sleep to
health and well being, yet research studies continue to show that
millions of Americans are at risk for the serious health, safety
consequences of sleep disorders and inadequate sleep. Moreover their
quality of life suffers and the personal and national economic impact
is staggering. NSF believes that every American needs to understand
that good health includes healthy sleep, just as it includes regular
exercise and balanced nutrition. We must elevate sleep to the top of
the national health agenda. We need your help to make this happen.
Our biggest challenge is bridging the gap between the outstanding
scientific advances we have seen in recent years and the level of
knowledge about sleep held by health care practitioners, educators,
employers, and the general public. This gap in knowledge is being
discussed as I present this testimony today, by hundreds of concerned
professionals. Yesterday and today, the National Center on Sleep
Disorders Research, the National Heart, Lung, and Blood Institute, and
the Trans-NIH Sleep Research Coordinating Committee are sponsoring a
translational conference entitled ``Frontiers of Knowledge in Sleep and
Sleep Disorders: Opportunities for Improving Health and Quality of
Life.'' This two-day program has assembled health care providers,
public health and education experts, policy makers, patient advocacy
organizations, sleep medicine specialists, and other stakeholders. It
is intended to address how information about sleep and sleep disorders
can translate into improvements in public health and safety using cost-
effective, comprehensive, and broadly-applied strategies for education,
societal change, and improved sleep-related health care.
This conference is an important step in translating research into
practice and into a broad-based public health message. The development
of a sleep education and public awareness initiative would serve as a
key legacy for the sleep translational conference and provide a forum
for dissemination of the outcomes of the sleep translational
conference. The National Sleep Foundation has been leading the way on
public education regarding sleep and sleep disorders since it was
founded in 1990. NSF and others have done a lot, but so much more needs
to be done in order to educate the public and actually change behavior.
Because resources are limited and the challenges great, we think
creative and new partnerships need to be created to address the issues
that are before us.
Therefore, we recommend that The National Center on Sleep Disorders
Research be encouraged to partner with other federal agencies, such as
the Centers for Disease Control and Prevention, and voluntary health
organizations, such as NSF, to develop an ongoing, inclusive mechanism
for public and professional awareness on sleep, sleep disorders, and
the consequences of fatigue. Such a collaboration between federal
agencies and voluntary health organizations would create an opportunity
for dramatically improving public health and safety as well as the
quality of life for millions, if not all, Americans.
Thank you again for the opportunity to present testimony before you
today. I would be pleased to address any comments or questions.
______
Prepared Statement of the International Foundation for Functional
Gastrointestinal Disorders
SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS
--Provide a 10 percent increase, to $30.8 billion, for fiscal year
2005 to the National Institutes of Health (NIH) budget. Within
NIH, provide proportional increases of 10 percent to the
various institutes and centers, specifically, the National
Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK). We request NIDDK's budget to be increased by 10
percent to $1.85 billion.
--Continue to accelerate funding for extramural clinical and basic
functional gastrointestinal research at NIDDK.
--Continue to urge NIDDK to develop a strategic plan setting research
goals on IBS and functional bowel diseases and disorders.
--Urge NIDDK to develop a standardization of scales to measure
incontinence severity and quality of life and to develop
strategies for primary prevention of fecal incontinence
associated with childbirth.
--Provide funding to NIDDK and the National Cancer Institute (NCI)
for more research on the causes of esophageal cancer.
Chairman Specter and members of the Subcommittee, thank you for the
opportunity to present this written statement regarding the importance
of functional gastrointestinal and motility research at the National
Institutes of Health.
IFFGD, the International Foundation for Functional Gastrointestinal
Disorders, has been serving the digestive disease community for 13
years. We work to broaden the understanding about functional
gastrointestinal and motility disorders in adults and children.
Through publications, professional symposia, and other means IFFGD
addresses issues and raises awareness about disorders and diseases that
many people are uncomfortable and embarrassed to talk about. Bowel
conditions are often hidden in our society. Not only are they
misunderstood, but the burden of illness and human toll has not been
fully recognized.
The majority of the diseases and disorders we address have no cure.
We have yet to completely understand the pathophysiology of the
underlying conditions. Many patients face a life of learning to manage
chronic illnesses that are often accompanied by pain and a variety of
gastrointestinal symptoms. The costs associated with these diseases are
great; conservative estimates range between $25-$30 billion annually.
The human toll is not only on the individual but also on the family.
Economic costs spill over into the workplace and every aspect of daily
life. In essence these diseases reflect lost potential for the
individual and society.
FECAL INCONTINENCE
At least 6.5 million Americans suffer from fecal incontinence.
Incontinence is neither part of the aging process nor is it something
that affects only the elderly. Incontinence crosses all age groups from
children to older adults, but is more common among women and in the
elderly of both sexes. Often it is a symptom associated with various
neurological diseases and cancer treatments. Yet, as a society, we
rarely hear or talk about the bowel disorders associated with multiple
sclerosis, diabetes, colon cancer, uterine cancer, and a host of other
diseases.
Causes of fecal incontinence are many and may include damage to the
anal sphincter muscles, nerve damage, loss of storage capacity in the
rectum, chronic diarrhea, or pelvic floor dysfunction. People who have
fecal incontinence may feel ashamed, embarrassed, or humiliated.
Society is not tolerant of loss of bowel control. Some individuals with
incontinence don't want to leave the house out of fear they might have
an episode of incontinence in public. Most try to hide the problem as
long as possible and may not reveal it to their own doctor unless
asked. Isolation adds to the burden of illness as these individuals
withdraw from friends and family, and social support.
In November 2002, IFFGD sponsored, with NIH support, a
multidisciplinary consensus conference--``Advancing the Treatment of
Fecal and Urinary Incontinence Through Research: Trial Design, Outcome
Measures, and Research Priorities.'' The proceedings were disseminated
in the January 2004 Supplement of Gastroenterology, the journal of the
American Gastroenterological Association. Among other outcomes, the
conference resulted in six key research recommendations to address
currently unmet needs:
1. More comprehensive identification of quality of life issues
associated with fecal incontinence and improved assessment and
communication of treatment outcomes related to quality of life.
2. Standardization of scales to measure incontinence severity and
quality of life.
3. Assessment of the utility of diagnostic tests for affecting
management strategies and treatment outcomes.
4. Development of new drug compounds offering new treatment
approaches to fecal incontinence.
5. Development and testing of strategies for primary prevention of
fecal incontinence associated with childbirth.
6. Further understanding of the process of stigmatization as it
applies to the experience of individuals with fecal incontinence.
IRRITABLE BOWEL SYNDROME (IBS)
IBS affects between 25 and 45 million people of all ages in the
United States (an estimated 10 to 15 percent of the population). The
disorder affects people of all ages, even children. Approximately 60 to
65 percent of IBS sufferers in the United States are reportedly female
and 35 to 40 percent are male. This chronic disease is characterized by
a group of symptoms, which can include abdominal pain or discomfort
associated with a change in bowel pattern, such as loose or frequent
bowel movements, and/or hard or infrequent bowel movements. Although
the cause of IBS is not understood, it is becoming clear that this
disease needs a multidisciplinary approach in research.
Similar to other chronic illnesses and depending on severity, IBS
can be emotionally and physically debilitating. Because of persistent,
unpredictable, and often painful bowel symptoms, maintaining work or
academic schedules becomes challenging. Individuals who suffer from
this disorder may distance themselves from social activities and even
may fear leaving their home.
In the House and Senate Fiscal Year 2004 Labor, Health and Human
Services, and Education Appropriations bills, Congress recommended that
the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) develop an IBS strategic plan. The development of a strategic
plan on IBS would greatly increase the institute's progress toward the
needed research on this functional gastrointestinal disorder.
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Gastroesophageal reflux disease, or GERD, is a very common disorder
affecting both adults and children, which results from the back-flow of
acidic stomach contents into the esophagus. GERD is often accompanied
by persistent symptoms, such as chronic heartburn and regurgitation of
acid. But sometimes there are no apparent symptoms, and the presence of
GERD is revealed when complications become evident. Symptoms of GERD
vary from person to person. The majority of people with GERD have mild
symptoms, with no visible evidence of tissue damage and little risk of
developing complications. However, periodic heartburn is a symptom so
common that many people overlook its potential to cause tissue damage
and disease. This is unfortunate because, through awareness and a
diagnosis, individuals can receive one of several treatment options
available for GERD. Untreated, GERD may lead to severe complications
such as inflammation, stricture, or Barrett's esophagus, a potentially
pre-cancerous condition.
Gastroesophageal reflux, involving regurgitation of gastric
contents into the esophagus, affects as many as one-third or more of
all full term infants born in America each year, but generally resolves
by 6 to 12 months of age. Gastroesophageal reflux disease (GERD)
results when symptoms persist or tissue damage occurs. Medical therapy
may then be required in order to control the disease, which in infants
commonly manifests as symptoms such as regurgitation with poor weight
gain, esophagitis, respiratory symptoms, or irritability. In children
and adolescents, the natural history of GERD is similar to that of
adult patients, in whom GERD tends to be persistent and may require
long-term treatment.
ESOPHAGEAL CANCER
Approximately 13,000 new cases of esophageal cancer are diagnosed
every year in this country. Although the causes of this cancer are
unknown, it is thought that it may be more prevalent in individuals who
develop Barrett's esophagus. Diagnosis usually occurs when the disease
is in an advanced stage; early effective screening tools are needed.
GASTROINTESTINAL MOTILITY DISORDERS
Gastrointestinal motility disorders can affect any part or parts of
the gastrointestinal tract. Gastroparesis, chronic intestinal pseudo-
obstruction (CIP), and Hirschsprung's disease, are just a few examples
of gastrointestinal motility disorders.
Gastroparesis is a painful disorder where the nerves to the stomach
are damaged or stop working, which leads to the stomach taking too long
to empty its contents. Symptoms of gastroparesis can include: nausea,
vomiting, early satiety or an early feeling of fullness when eating,
weight loss, abdominal bloating, and abdominal discomfort. This
disorder is often a complication of diabetes. An estimated 20 percent
of people with type 1 diabetes develop gastroparesis. Individuals with
type 2 diabetes can also develop gastroparesis.
Approximately, 200 new cases of Chronic Intestinal Pseudo-
Obstruction or CIP are diagnosed in American children each year. This
rare and serious disorder occurs when coordinated contractions, or
peristalsis, in the intestinal tract become altered and inefficient.
When this happens, nutritional requirements cannot be adequately met.
CIP is often life threatening and treatment challenging. Continued
clinical and basic research is needed before the disease is fully
understood, and improved treatment or ultimately a cure found.
Hirschsprung's disease (HD) is a serious and sometimes life-
threatening congenital disorder that is caused by absence of nerve
cells in the rectum and/or colon, which can cause obstruction,
inflammation, and severe constipation. It occurs in about one out of
every 5,000 American children born each year. The treatment is
primarily surgical to remove the abnormal bowel. Approximately 10-20
percent of children with HD will continue to have complications
following surgery. These complications include infection, fecal
incontinence, and persistent constipation.
FUNCTIONAL GASTROINTESTINAL AND MOTILITY DISORDERS AND THE NATIONAL
INSTITUTES OF HEALTH
The International Foundation for Functional Gastrointestinal
Disorders recommends an increase to $30.8 billion or 10 percent for NIH
overall, and a 10 percent increase for NIDDK, or $1.85 billion.
However, we request that this increase for NIH does not come at the
expense of other Public Health Service agencies.
We urge the subcommittee to provide the necessary funding for the
expansion of the NIDDK's research program on functional
gastrointestinal (GI) and motility disorders, this increased funding
will allow for the growth of new research, a prevalence study and a
strategic plan on IBS, and increased public and professional awareness
of functional GI and motility disorders.
A primary goal of IFFGD's mission is to ensure that advancements
concerning GI disorders result in improvements in care and the quality
of life of those affected. As we all work together, it is hoped this
goal will be realized and the suffering and pain millions of people
face daily will end.
Mr. Chairman, on behalf of millions of patients and the families of
those with functional GI or motility disorders thank you for your
consideration.
The International Foundation for Functional Gastrointestinal Disorders
The International Foundation for Functional Gastrointestinal
Disorders is a nonprofit education and research organization founded in
1991. IFFGD addresses the issues surrounding life with gastrointestinal
(GI) functional and motility disorders and increases the awareness
about these disorders among the general public, researchers, and the
clinical care community.
______
Prepared Statement of the Hepatitis Foundation International
SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS
--Continue the great strides in research and prevention at the
National Institutes of Health (NIH) by providing a 10 percent
budget increase for fiscal year 2005. Increase funding for the
National Institute for Allergy and Infectious Diseases (NIAID)
and the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) by 10 percent.
--$41 million in fiscal year 2005 for a hepatitis B vaccination
program for high risk adults at CDC as recommended by the
National Hepatitis C Prevention Strategy.
--$40 million in fiscal year 2005 for CDC's Prevention Research
Centers.
--Continued support of the National Viral Hepatitis Roundtable.
Mr. Chairman and members of the subcommittee thank you for your
continued leadership in promoting better research, prevention, and
control of diseases affecting the health of our nation. I am Thelma
King Thiel, Chairman and Chief Executive Officer of the Hepatitis
Foundation International (HFI), representing members of 425 patient
support groups across the nation, the majority of whom suffer from
chronic viral hepatitis.
Currently, five types of viral hepatitis have been identified,
ranging from type A to type E. All of these viruses cause acute, or
short-term, viral hepatitis. Hepatitis B, C, and D viruses can also
cause chronic hepatitis, in which the infection is prolonged, sometimes
lifelong. While treatment options are available for all types of
hepatitis, individuals with chronic viral hepatitis (types B, C, and D)
represent the majority of liver failure and transplant patients.
Treatment options and immunizations are available for most types of
hepatitis (see below). However, all types of viral hepatitis are
preventable.
HEPATITIS A
The hepatitis A virus (HAV) is contracted through fecal/oral
contact (i.e. fecal contamination of food, or diaper changing tables if
not cleaned properly), and sexual contact. In addition, eating raw or
partially cooked shellfish contaminated with HAV can spread the virus.
Children with HAV usually have no symptoms; however, adults may become
quite ill suddenly experiencing jaundice, fatigue, nausea, vomiting,
abdominal pain, dark urine/light stool, and fever. There is no
treatment for HAV; however, recovery occurs over a 3 to 6 month period.
About 1 in 1,000 with HAV suffer from a sudden and severe infection
that may require a liver transplant. Luckily, a highly effective
vaccine can prevent HAV. This vaccination is recommended for
individuals who have chronic liver disease (i.e. HCV or HBV) or
clotting factor disorders, in addition to those who travel or work in
developing countries.
HEPATITIS B
Hepatitis B (HBV) claims an estimated 5,000 lives every year in the
United States, even though we have therapies to both prevent and treat
this disease. This disease is spread through contact with the blood and
body fluids of an infected individual. Unfortunately, due to both a
lack in funding to vaccinate adults at high risk of being infected and
the absence of an integrated preventive education strategy,
transmission of hepatitis B continues to be problematic. Additionally,
there are significant disparities in the occurrence of chronic HBV-
infections. Asian Americans represent four percent of the population;
however, they account for over half of the 1.3 million chronic
hepatitis B cases in the United States. Current treatments have limited
success in treating the chronically infected and there is no treatment
available for those who are considered ``HBV carriers.'' Preventive
education and vaccination are the best defense against hepatitis B.
HEPATITIS C
Infection rates for hepatitis C (HCV) are at epidemic proportions.
Unfortunately, as many are not aware of their infection until several
years after infection, we are dealing with an ``epidemic of
discovery.'' This creates a vicious cycle, as individuals who are
infected continue to spread the disease, unknowingly. Hepatitis C is
also spread through contact with an infected individual's blood. The
CDC estimates that there are over 4 million Americans who have been
infected with hepatitis C, of which over 2.7 million remain chronically
infected, with 8,000-10,000 deaths each year. Additionally, the death
rate is expected to triple by 2010 unless additional steps are taken to
improve outreach and education on the prevention of hepatitis C, new
research is undertaken, and case-finding is enhanced and more effective
treatments are developed. As there is no vaccine for HCV, prevention
education and treatment of those who are infected serve as the most
effective approach in halting the spread of this disease.
PREVENTION IS THE KEY
Only a major investment in immunization and preventive education
will bring these diseases under control. All newborns, young children,
young adults, and especially those who participate in high-risk
behaviors must be a priority for immunization, outreach initiatives and
preventive education. We recommend that the following activities be
undertaken to prevent the further spread of all types of hepatitis:
--Provide effective preventive education in our elementary and
secondary schools helping children avoid the ravages of health
problems resulting from viral hepatitis infection.
--Training educators, health care professionals, and substance abuse
counselors in effective communication and counseling
techniques.
--Public awareness campaigns to alert individuals to assess their own
risk behaviors, motivate them to seek medical advice, encourage
immunization against hepatitis A and B, and to stop the
consumption of any alcohol if they have participated in risky
behaviors that may have exposed them to hepatitis C.
--Expansion of screening, referral services, medical management,
counseling, and prevention education for individuals who have
HIV/AIDS, many of whom may be co-infected with hepatitis.
HFI recommends an increase of $41 million in fiscal year 2005 for
further implementation of CDC's Hepatitis C Prevention Strategy. This
increase will support and expand the development of state-based
prevention programs by increasing the number of state health
departments with CDC funded hepatitis coordinators. The Strategy will
use the most cost-effective way to implement demonstration projects
evaluating how to integrate hepatitis C and hepatitis B prevention
efforts into existing public health programs. Additionally, HFI
recommends that $10 million be used to train and maintain hepatitis
coordinators in every state.
CDC's Prevention Research Centers, an extramural research program,
plays a critical role in reducing the human and economic costs of
disease. Currently, CDC funds 26 prevention research centers at schools
of public health and schools of medicine across the country. HFI
encourages the Subcommittee to increase core funding for these
prevention centers, as it has been decreasing since this program was
first funded in 1986. We recommend the Subcommittee provide $40 million
for the Prevention Research Centers program in fiscal year 2005.
INVESTMENTS IN RESEARCH
Investment in the National Institutes of Health (NIH) has led to an
explosion of knowledge that has advanced understanding of the
biological basis of disease and development of strategies for disease
prevention, diagnosis, treatment, and cures. Countless medical advances
have directly benefited the lives of all Americans. NIH-supported
scientists remain our best hope for sustaining momentum in pursuit of
scientific opportunities and new health challenges. For example,
research into why some HCV infected individuals resolve their infection
spontaneously may prove to be life saving information for others
currently infected. Other areas that need to be addressed are:
--Reasons why African Americans do not respond to antiviral agents in
the treatment of chronic hepatitis C.
--Pediatric liver diseases, including viral hepatitis.
--The outcomes and treatment of renal dialysis patients who are
infected with HCV.
--Co-infections of HIV/HCV and HIV/HBV positive patients.
--Hemophilia patients who are co-infected with HIV/HCV and HIV/HBV.
--The development of effective treatment programs to prevent
recurrence of HCV infection following liver transplantation.
--The development of effective vaccines to prevent HCV infection.
The Hepatitis Foundation International supports a 10 percent
increase for NIH in fiscal year 2005. HFI also recommends a comparable
increase of 10 percent in hepatitis research funding at the National
Institute of Diabetes and Digestive and Kidney Diseases and the
National Institute of Allergy and Infectious Diseases.
NATIONAL VIRAL HEPATITIS ROUNDTABLE
Victims of hepatitis suffer emotionally as well as physically. They
experience discrimination in employment, strained personal
relationships and severe depression when treatments fail to control
their illness as well as during their treatment. Traditionally,
however, there has not been an organized effort to periodically convene
all stakeholder organizations that play a role in hepatitis prevention,
education, treatment and patient advocacy. Successfully addressing
viral hepatitis will require a comprehensive and strategic approach
developed by all key stakeholders.
In order to fill this void, HFI and CDC co-founded the ``National
Viral Hepatitis Roundtable.'' HFI believes that a National Viral
Hepatitis Roundtable will enhance and assist CDC's viral hepatitis
mission for the prevention, control, and elimination of hepatitis virus
infections in the United States, as well as the international public
health community. It will provide an infrastructure for the sharing of
information and education of all stakeholders.
The ``National Viral Hepatitis Roundtable'' is a coalition of
public, private, and voluntary organizations dedicated to reducing the
incidence of infection, morbidity, and mortality from viral hepatitis
in the United States through research, strategic planning,
coordination, advocacy, and leadership.
HFI is dedicated to the eradication of viral hepatitis, which
affects over 500 million people around the world. We seek to raise
awareness of this enormous worldwide problem and to motivate people to
support this important--and winnable--battle. Thank you for providing
this opportunity to present our testimony.
The Hepatitis Foundation International
The Hepatitis Foundation International (HFI) is dedicated to the
eradication of viral hepatitis, a disease affecting over 500 million
people around the world. We seek to raise awareness of this enormous
worldwide problem and to motivate people to support this important--and
winnable--battle.
Our mission has four distinct parts:
--Teach the public and hepatitis patients how to prevent, diagnose,
and treat viral hepatitis.
--Prevent viral hepatitis by promoting liver wellness and healthful
lifestyles.
--Serve as advocates for hepatitis patients and the related medical
community worldwide.
--Support research into prevention, treatment, and cures for viral
hepatitis.
______
Prepared Statement of the Charles R. Drew University of Medicine and
Science
SUMMARY OF RECOMMENDATIONS FOR FISCAL YEAR 2005
--A 10 percent increase for all institutes and centers at the
National Institutes of Health (NIH), specifically the National
Center for Research Resources (NCRR), the National Center for
Minority Health and Health Disparities (NCMHD), and the
National Cancer Institute (NCI).
--Urge NCI to continue to support the establishment of collaborative
minority health comprehensive cancer centers at historically
minority institutions in collaboration with existing NCI cancer
centers. Continue to urge NCRR and NCMHD to collaborate on the
establishment of a cancer center at a historically minority
institution.
--Urge the Department of Health and Human Services, particularly the
Office of Minority Health (OMH), to develop a focused effort on
faculty support to address the residency training programs at
minority medical institutions.
Mr. Chairman and members of the subcommittee, thank you for the
opportunity to present you with testimony. Charles R. Drew University
is one of four predominantly minority medical schools in the country,
and the only one located west of the Mississippi River.
Charles R. Drew University of Medicine and Science is located in
the Watts-section of South Central Los Angeles, and has a mission of
rendering quality medical education to underrepresented minority
students, and, through its affiliation with the University of
California Los Angeles (UCLA) at the co-located King-Drew Medical
Center, Drew provides valuable health care services to the medically
underserved community. Through innovative basic science, clinical, and
health services research programs, Drew University works to address the
health and social issues that strike hardest and deepest among inner
city and minority populations.
The population of this medically underserved community is
predominately African American and Hispanic. Many of these people would
be without health care if not for the services provided by the King-
Drew Medical Center and Charles R. Drew University of Medicine and
Science. This record of service has led Charles R. Drew University (in
partnership with UCLA School of Medicine) to be designated as a Health
Resources and Services Administration Minority Center of Excellence.
A RESPONSE TO HEALTH DISPARITIES
Racial and ethnic disparities in health outcomes for a multitude of
major diseases in minority and underserved communities continue to
plague this nation that was built on a premise of equality. As
articulated in the Institute of Medicine report entitled ``Unequal
Treatment: Confronting Racial and Ethnic Disparities in Health Care'',
this problem is not getting better on its own. For example, African
American males develop cancer 15 percent more frequently than white
males. Similarly, African American women are not as likely as white
women to develop breast cancer, but are much more likely to die from
the disease once it is detected. In fact, according to the American
Cancer Society, those who are poor, lack health insurance, or otherwise
have inadequate access to high-quality cancer care, typically
experience high cancer incidence and mortality rates. Despite these
devastating statistics, we are still not doing enough to try to combat
cancer in our communities.
In response to these findings and the high cancer rate in our own
community, Charles R. Drew University of Medicine and Science proposes
that a Minority Health Comprehensive Cancer Center be built on its
campus.
The Center would specialize in providing not only medical treatment
services for the community, but would also serve as a research
facility, focusing on prevention and the development of new strategies
in the fight against cancer.
Mr. Chairman, the support that this subcommittee has given to the
National Institutes of Health (NIH) and its various institutes and
centers has and continues to be invaluable to our University and our
community. The dream of a state of the art facility to aid in the fight
against cancer in our underserved community would be impossible without
the resources of NIH.
To help facilitate the establishment of a Minority Health
Comprehensive Cancer Center at Charles R. Drew University of Medicine
and Science, the University is seeking support from the National
Institutes of Health's National Center for Research Resources (NCRR),
the National Center for Minority Health and Health Disparities (NCMHD),
and the National Cancer Institute (NCI).
ACADEMIC RENEWAL AND CLINICAL FACULTY RECRUITMENT
Some of the major challenges faced in sustaining high quality
graduate medical education programs in ``safety-net'' medical centers
with missions focused on the medically underserved, are directly
related to the lack of sufficient numbers of clinical faculty highly
trained in academic medicine. To address these challenges, a plan for
academic enrichment is proposed.
The plan is a strategic initiative to position Charles R. Drew
University in the first decade of the 21st Century, as a leader in
Urban Academic Health Sciences with an emphasis on training physicians
and other health professionals to meet the needs of the medically
underserved. The Plan for Academic Enrichment is an opportunity to
enhance the impact of Charles R. Drew University as a national center
of excellence in meeting the national, state, and local challenge of
preparing a diverse complement of excellent physicians and other health
professionals to close the health disparity gap by affording culturally
sensitive quality care to the medically underserved and economically
disadvantaged. A central component of the plan is the enrichment of
academic excellence through the recruitment of new, highly qualified
clinical teaching faculty, with solid research skills, to be members of
the Charles R. Drew College of Medicine faculty to strengthen both the
graduate and undergraduate medical education programs.
CONCLUSION
Despite our knowledge about racial/ethnic, socio-cultural and
gender-based disparities in health outcomes, the ``gap'' continues to
widen in most instances. Not only are minority and underserved
communities burdened by higher disease rates, they are less likely to
have access to quality care upon diagnosis. As you are aware, in many
minority and underserved communities preventive care and/or research is
completely inaccessible either due to distance or lack of facilities
and expertise. This is a critical loss of untapped potential in both
physical and intellectual contributions to the entire society.
Even though institutions like Drew are ideally situated (by
location, population, and institutional commitment) for the study of
conditions in which health disparities have been well documented,
research is limited by the paucity of appropriate research facilities.
With your help, this cancer center will facilitate translation of
insights gained through research into greater understanding of
disparities in cancer incidence, morbidity and mortality and ultimately
to improved outcomes.
We look forward to working with you to lessen the burden of cancer
for all Americans through greater understanding of cancer, its causes,
and its cures. We also look forward to working with the Department of
Health and Human Services to address the residency training program
issues at Charles R. Drew University.
Mr. Chairman, thank you for the opportunity to present on behalf of
Charles R. Drew University of Medicine and Science.
______
Prepared Statement of Mended Hearts, Inc.
I am Robert H. Gelenter, the legal representative for the Mended
Hearts, Inc, a national heart disease patient support group of more
than 289 chapters across the country and in Canada. We visit patients
in about 460 hospitals throughout the United States. I have been
appointed by the group to assist in this lobbying effort--a volunteer
position.
More than 28 years ago, I was diagnosed with a rare heart disease.
After having severe chest pains and trouble breathing for more than 2
years, I was diagnosed with hypertrophic cardiomyopathy, a disease in
which the heart enlarges. The heart muscle eventually thickens so much
that it can't pump blood effectively and does not grow in the normal
parallel patterns. An estimated 36 percent of young athletes who die
suddenly die from this disease. But, it affects men and women of all
ages. It is sudden and one of the things known about this disease is
sudden cardiac death. There is no cure for this disease. Medication may
work and there is surgery that may or may not alleviate the pain. If
that doesn't work a patient may need a heart transplant, yet spare
organs are scarce. The doctor who made my diagnosis was trained at the
National Heart, Lung, and Blood Institute of the National Institutes of
Health.
Initially, I received several medications which allowed me to
engage in most activities. But, some activities, such as walking up
hills, gave me problems like shortness of breath and severe chest
pains. But, generally I could function normally. However, after about
11 years, the discomfort was increasing, and it became apparent that I
was in serious trouble. I could not walk 60 feet without having to stop
to catch my breath. Sometimes the pain was so great that I would almost
double over in the middle of the street. My wife told me that my face
would become gray. The perspiration would pour off by body. If I was
lucky I could find a chair to sit on. The quality of my life had
deteriorated so drastically that I knew I needed some treatment.
Finally in 1988, I went to Georgetown University Medical Center for
an angiogram--the gold standard for diagnosing heart problems. The
cardiologist who performed the angiogram told me that he had bad news
and worse news. The bad news was that I had a 95 percent blockage in my
left anterior descending heart artery--the so-called ``widow makers
spot.'' The worse news was that I had a major chance of having a major
heart attack with a less than a 5 percent chance of surviving that
heart attack because of the hypertrophic cardiomyopathy. At this point,
my wife was quietly crying and I was perspiring profusely. Since
Georgetown University Medical Center did not have the expertise to
operate on me, they called the NIH to see if they would accept me as a
patient. I was sent home pending notice from the NIH.
My parents begged me to go to New York or San Francisco for second
opinions. But, I knew that I had run out of alternatives. No matter
what the result, I needed treatment and I needed it immediately.
I was accepted by the NIH. After entering the National Heart, Lung,
and Blood Institute on February 6, I was operated on February 11, 1988.
No matter how trite the expression--that was the first day of the rest
of my life. The surgery, considered drastic and rare, is still
considered the gold standard throughout the world for the treatment of
hypertrophic cardiomyopathy. The Murrow Procedure, in honor of the
creator, was developed and improved at the NIH.
Although this surgery is no longer performed at the National Heart,
Lung, and Blood Institute, there is another experimental ongoing
protocol in which the same effect is being attempted by using alcohol
to deaden the excessive heart tissue.
Now, I am on medication for the rest of my life. My condition is
progressive. Eight years ago, I was fitted with a pacemaker to insure
that my heart beats at the correct rate. I am 100 percent dependent on
this pacemaker. Without the pacemaker, there are times when my normal
heart beat is so slow that I would die.
I am eternally grateful to the physicians funded by the National
Heart, Lung, and Blood Institute, particularly to Dr. MacIntosh and his
staff, for the gift of life. Because of this marvelous research
supported by the NHLBI, I have lived 15 years pain free. I have seen
two children graduate from college and three grandchildren born, I have
shared these years with a wonderful wife. I have been able to work at
my profession--an attorney at law.
I have had the gift of life restored to me. So to express my
gratitude for that gift, I visit patients recovering from heart
episodes at two hospitals, Washington Hospital Center and Washington
Adventist Hospital.
I ask for an fiscal year 2005 appropriation of $3.5 billion for the
NHLBI, including $2.1 billion for its heart disease and stroke-related
budget.
My experience is the proof that the research supported by the
National Heart, Lung, and Blood Institute benefits not just the
patients at the NIH Clinical Center, but throughout the United States.
The benefits go worldwide as well.
Heart attack, stroke and other cardiovascular diseases remain the
No. 1 killer and major cause of disability of men and women in the
United States. Nearly 40 percent of people who die in the United States
die from cardiovascular diseases. This year, more than 930,000
Americans will die from cardiovascular diseases, including almost
150,000 under the age of 65.
Thank you for your support of National Heart, Lung, and Blood
Institute's heart research.
______
Prepared Statement of the American College of Cardiology
INTRODUCTION
The American College of Cardiology (ACC) is a 30,890 member non-
profit professional medical society and teaching institution whose
mission is to advocate for quality cardiovascular care--through
education, research promotion, development and application of standards
and guidelines--and to influence health care policy. The College
represents more than 90 percent of the cardiovascular specialists
practicing in the United States. The ACC submits for the record this
statement of support for increased funding for heart-related research
through the National Heart, Lung, and Blood Institute (NHLBI) in fiscal
year 2005, as well as support for increased funding for the Agency for
Health Care Research and Quality (AHRQ), education and awareness
programs through the Centers for Disease Control and Prevention (CDC)
State Heart Disease and Stroke Prevention Program, and state and local
programs designed to increase public access to automated external
defibrillators (AEDs).
The ACC expresses its appreciation to Congress for successfully
completing the doubling of the NIH budget by fiscal year 2003. Although
the increase in funding has greatly benefited cardiovascular-related
research, the National Institutes of Health (NIH) still invests only 8
percent of its budget on heart research and a mere 1 percent on stroke
research--a funding level that fails to reflect that 40 percent of all
deaths in this country are attributable to cardiovascular disease. The
ACC appreciates current budget constraints, but hopes this subcommittee
will continue its commitment toward medical research funding and the
improvement of public health in the fiscal year 2005 budget. According
to a recent study conducted by MEDTAP International and co-sponsored by
the ACC, national health advancements since 1980 are due primarily to
investments in health care, and for each additional dollar spent in the
United States for health care services $2.40 to $3.00 in tangible gains
have been made.
The ACC, however, is concerned that President Bush's proposed
fiscal year 2005 budget calls for only a 2.6 percent increase above
fiscal year 2004 levels for the NIH and only a 0.3 percent increase for
the CDC's Heart Disease and Stroke Prevention Program. Low-level
funding increases for NIH, in addition to inadequate funding levels
proposed in the President's budget for enhanced public access to AEDs,
and the flat-funding proposed for the AHRQ, is of great concern to the
ACC and its members.
Cardiovascular disease continues to claim more lives each year than
the next seven leading causes of death combined. Recent data shows that
in 2001 more than 64 million Americans were shown to have suffered from
at least one form of cardiovascular disease, of which nearly 1 million
died as a direct result. The overall (indirect and direct) cost of
cardiovascular disease for 2004 is estimated to be at least $368.4
billion. Heart disease is not only tragically rampant in the United
States, but it is also financially burdensome. The ACC believes that
further investment in life-saving research, as well as in education and
awareness programs, is essential to combat the leading cause of death
of men and women in this country.
The ACC Supports the Following fiscal year 2005 Appropriations
Funding Levels:
--NIH (overall funding)--$30.6 billion
--NHLBI--$3.5 billion (includes $2.1 billion for heart- and stroke-
related activities)
--AHRQ--$443 million
--CDC State Heart Disease and Stroke Prevention Program--$80 million
--Community and Rural AED Access--$45 million
MEDICAL RESEARCH
The ACC believes that the federal government must expand its
financial commitment to medical research, most specifically at the
NHLBI, through support for the NIH and its new ``NIH Roadmap''
initiative which was initiated at NIH to help identify major
opportunities and gaps in biomedical research and allow for greater
collaboration between all NIH institutes. Increased NHLBI funding over
the years has allowed investigators to develop better diagnostic tools
and surgical techniques, as well as study new methods of treatment for
cardiac patients. We must aim for better patient prevention, early
cardiovascular disease diagnoses, and improved treatment of our
patients. As such, the ACC is particularly supportive of initiatives
related to clinical cardiology and issues of clinical relevance to the
practice of cardiology. The ACC also firmly believes in the value of
promoting clinical investigative careers and of large-scale clinical
trials which aid the discovery and application of therapeutic and/or
medical treatments to cardiovascular disease. In addition, the ACC
would like to stress the importance of funding the AHRQ at a level that
allows for their continued application of research to cardiovascular
care. AHRQ activities play a large role in ensuring that our members
can provide patients with the most up-to-date and effective treatments
available.
Research Success Due to Past Legislative Investment in NHLBI
Another major advancement during the NIH doubling was with the
implementation of a major clinical trial testing approaches to lowering
the risk of cardiovascular disease in adults with Type 2 diabetes.
Seventy percent of Americans diagnosed with Type 2 diabetes ultimately
die of cardiovascular disease. The ACC is quite concerned about the
cardiovascular health impact of diabetes and obesity in Americans,
particularly in children. This trial, referred to as Action to Control
Cardiovascular Risk in Diabetes (ACCORD) evaluates the effects of
intense blood sugar control along with very aggressive control of blood
pressure and lipids. The overall goal of ACCORD is to discover a better
treatment for those suffering from Type 2 diabetes than is presently
available. The ACC is pleased to see research attention being paid to
the correlation of diabetes and metabolic syndromes with cardiovascular
disease, because this devotion of resources helps to gain a better
understanding of and treatment methods for these debilitating diseases.
Research Success Due to Investments in Women and Heart Disease
This year, more women than men will die from cardiovascular
disease, making the inclusion of women in more heart-related research
studies absolutely integral. Since 1984, men have experienced a decline
in deaths due to cardiovascular disease, yet despite a growing number
of female-specific research initiatives, women have not yet experienced
this decline.
To this end, the ACC is proud to be participating in several
national campaigns this year that help raise awareness about the
incidence and morbidity of heart disease and stroke in women, including
the NHLBI's The Heart Truth, and the American Heart Association's ``Go
Red for Women.'' In addition, on February 20, 2004, the ACC teamed with
the Sister to Sister Foundation for its National Woman's Heart Day to
help provide free screenings, educational seminars, cardiovascular
health information, and fitness and cooking demonstrations to women
around the country. The ACC is pleased that new clinical studies are
underway at NIH that will hopefully help clarify the gender differences
that directly affect diagnosis and treatment of women with heart
disease.
Women's Health Initiative
Thanks to Congress' financial commitment during the doubling of the
NIH budget, the NHLBI was able to proceed with the Women's Health
Initiative (WHI) which yielded the first conclusive evidence of risks
associated with long-term estrogen plus progestin hormone replacement
therapy (HRT). This groundbreaking discovery changed the delivery of
care for millions of American women and raised the public's awareness
regarding heightened risks for heart attack, stroke and/or blood clots
during long-term HRT use. The ACC was pleased by the findings yielded
through the WHI and would like to see continued research focused on the
unique causes and outcomes of heart disease in women. The ACC also
believes that only through randomized clinical trials can we fully
understand how medicines and devices affect human health.
Women's Ischemia Syndrome Evaluation
The Women's Ischemia Syndrome Evaluation (WISE) Study is a four-
center, NHLBI study evaluating approximately 1,000 women referred for
elective diagnostic coronary angiography because of suspected ischemia,
a shortage of oxygen and blood to the heart muscle. It is the largest
NIH-funded study dedicated solely to women, with the goal of examining
the nature and scope of gender differences in both chronic and acute
cardiac ischemia.
Prior reports suggested that, compared with men, clinical
manifestations of ischemic heart disease in women appear approximately
10 or more years later. Women demonstrate more symptoms suggesting
ischemic heart disease, yet the symptoms in women, such as chest
discomfort and dyspnea, are more difficult to interpret.
There is now a better snapshot of the extent of cardiovascular
disease in women, thanks to WISE Study findings revealed at the ACC
Annual Scientific Session in March 2004 (ACC 2004) by Barry L. Sharaf,
M.D., F.A.C.C. Based on the 4-year, risk-adjusted outcomes by extent of
coronary disease, there was a 9.4 percent death or myocardial
infarction (MI) rate (or about 2.7 percent annually) in women with
minimal or no symptoms of disease detected by angiography. This is an
unacceptable event rate. In another presentation by Leslee J. Shaw,
Ph.D., at ACC 2004 regarding the WISE Study, the estimated lifetime
cost of care for cardiovascular disease detected by angiography was
detailed. Dr. Shaw found that women with no disease detectable by
angiography have in excess of three-quarters of a million dollars
lifetime costs for care. In an era of shrinking health care resources,
such a high cost is unsustainable. This high rate of death or
myocardial infarction, combined with escalating health care costs,
clearly demonstrates the need for improved detection of cardiovascular
disease in women.
The ACC believes it is imperative to increase awareness among women
about their risk of heart disease. Thanks to findings yielded from the
WISE Study, cardiovascular specialists are gaining a better
understanding that there is a ``female-pattern'' of ischemia-related
symptoms that is distinct from that seen in men. Cardiologists have
also come to understand that a ``clean'' angiogram in symptomatic women
does not mean a benign outcome. The ACC believes that the WISE Study
discoveries are a good start in unraveling the mystery of women and
heart disease, but more research looking at issues like concealed
plaque and inflammation in the vessel wall, the prognostic ability of
blood markers, and the role of the microvasculature, needs to be
conducted.
NHLBI Research Opportunities Threatened by President's Fiscal Year 2005
2.5 Percent Funding Increase
Much progress has been made in cardiovascular research and clinical
trials to this date, but the ACC believes that if the numbers proposed
in the President's fiscal year 2005 budget are instituted new and
exciting opportunities could be postponed if not cancelled, and the
continuation and/or expansion of current NHLBI cardiovascular research
programs could also be threatened. The ACC encourages Congress to take
necessary steps to avoid such a predicament through funding the NHLBI
at $3.5 billion in fiscal year 2005, so that the following
fundamentally important programs among others have a chance of
development.
Enhancing the Use of Longitudinal Data on Cardiovascular
Disease and its Risk Factors in Older Adults: The
Cardiovascular Health Study (CHS)
This initiative would allow for continued utilization of the data
and specimens collected during the CHS study which began in 1987 and is
set to terminate in 2005. Specifically, the initiative would ensure
access to CHS data and specimens to the entire scientific community and
allow for continued follow-up of study participants. Investigators are
particularly interested in the research and treatment of cardiovascular
disease in elderly patients (age 75 and older), a focus area which
could be enhanced through the use of longitudinal data obtained by the
CHS.
Randomized Trial of Heart Failure (HF) Management
ACC believes that the incorporation of clinical practice methods
and provider education into NHLBI trials benefits not only
cardiovascular patients but also the cardiologists who translate new
therapies into regular cardiovascular care techniques. This trial is a
perfect example of a mutually beneficial initiative. The multi-center/
randomized trial would assess costs, quality of life, physician
compliance, and patient adherence to prescribed treatments in order to
identify and disseminate clinically useful and effective tools for
translation of proven therapies for HF into clinical practice.
Community-Responsive Interventions to Reduce Cardiovascular
Risk in American Indians and Alaska Natives
Despite the fact that American Indians and Alaska Natives are
disproportionately affected by cardiovascular diseases, the President's
2.5 percent budget increase for NHLBI in fiscal year 2005 is inadequate
for fostering the development of preventative intervention into
community health care systems or through other health care means within
American Indian and Alaska Native communities. If instituted within the
fiscal year 2005 budget cycle, this NHLBI program would work to find
solutions to obesity, diabetes, and cardiovascular diseases within
these minority communities.
Priority Research Programs at NHLBI for Fiscal Year 2005
The NHLBI finds new and innovative methods for yielding research
and clinical trial results year after year. These results, when
translated into practice, ensure that cardiovascular specialists and
other health care providers are able to provide patients with the
highest quality care possible. Due largely to the medical research and
education programs supported by the NHLBI, many Americans who suffer
from or are at risk for cardiovascular disease now have access to a
greater variety of diagnostic tests, medical treatments, and
information about prevention. The research priorities set forth by the
NHLBI are a direct result of input from health care community,
including that of ACC members. The ACC believes it is imperative to
appropriately fund the NHBLI in fiscal year 2005 so that the NHLBI can
continue to create and implement ground-breaking cardiovascular
research.
Last year, the ACC recommended the implementation of an NHLBI
program titled ``Overweight and Obesity Prevention and Control at the
Worksite,'' which would support the design and testing of innovative
worksite intervention to prevent and control overweight and obesity in
adults. Almost two-thirds (61 percent) of American adults are
overweight or obese, and each year an estimated 300,000 American adults
die of causes related to obesity. The ACC is pleased that this program
has officially gained NHLBI recognition and is being considered for
implementation in fiscal year 2005. Some of the strategies within the
program include implementing environmental and policy changes to
increase employees' physical activity, offering healthful food choices
in cafeterias and vending machines, and enhancing social support from
fellow workers to encourage improved diet and physical activity. The
ACC encourages Congress to concur with this NHLBI-recommended program
and allow for full funding of the ``Overweight and Obesity Prevention
and Control at the Worksite'' in fiscal year 2005.
Currently there is a growing need to address cardiovascular
infections caused by the bacterium Staphylococcus aureus, commonly
referred to as Staph infections, following cardiac surgery. The ACC
believes that there is great value in fully funding the NHLBI-proposed
``Clinical Trials for the Prevention and Treatment of Infections after
Cardiac Surgery'' parallel randomized clinical trials. These trials
would provide conclusive evidence of the need for improved control of
Staph infections by assessing the costs and benefits of new
antibacterial strategies. Due to the serious risk of infection
following cardiac surgery, the ACC hopes that increased funding for the
NHLBI will allow these important trials to be conducted.
Collaboration among federal agencies has proven an effective and
efficient means for enhancing research, facilitating appropriate
regulation, and providing accurate clinical outcomes data. An
``Interagency Registry of Mechanical Circulatory Support for Heart
Failure'' would create a registry of mechanical circulatory support for
heart failure, as well as an associated tissue repository for shared
use by all related federal agencies. Such a registry would help
standardize reporting of patient characteristics, indications,
implantation procedures, and adverse events. With increased funding for
NHLBI in fiscal year 2005, such collaboration will be possible.
AHRQ--Moving Research into Practice
The research and education developments that the federal government
has facilitated are remarkable and promising. However, the best
research is of no value if it never reaches the patient. The AHRQ is
charged with ensuring that advances in medicine become the baseline for
medical care. By fulfilling the mission of placing today's
breakthroughs in the hands of physicians tomorrow, AHRQ injects up-to-
the-minute research into day-to-day medical decisions and treatments.
The research facilitated by the AHRQ provides reliable information on
health care outcomes, quality, cost, use, medical errors, and access,
enabling the public to make better-informed decisions about health
care. The ACC regularly works with AHRQ to create and disseminate
cardiovascular clinical practice guidelines. Having the AHRQ address
some of the evidence to practice issues remains a critical step in
evaluating the utility of practice guidelines.
For example, in fiscal year 2000, AHRQ released the ``Translating
Research into Practice II (TRIP II)'' request for applications (RFA).
The response to this RFA was overwhelming, so much so that currently 13
studies are underway due to this initiative. TRIP II specifically
focuses on increasing the frequency of partnerships between researchers
and health care systems and organizations to heighten the effect of
practice-based, patient outcome research in applied settings.
Although the AHRQ remains a vital partner to both the clinical
research community and other private sector organizations, it has not
received a funding increase in the past two budget cycles. This
continuous flat-funding does not allow the AHRQ to adjust to annual
inflationary costs, nor does it provide the opportunity for new
development or growth. The ACC is extremely concerned by this funding
plateau particularly because of the AHRQ's central role in reviewing
current scientific evidence and providing practical clinical
information to the public, such as its recent work on blood pressure
monitoring. The ACC urges Congress to support increased funding of the
AHRQ at $443 million in fiscal year 2005.
CARDIOVASCULAR DISEASE AWARENESS AND EDUCATION
CDC State Heart Disease and Stroke Prevention Program
Education and awareness campaigns that focus on for heart disease
and stroke prevention are in underway at the CDC's State Heart Disease
and Stroke Prevention Program, but progress has been stalled due to
insufficient funding. Only 11 of the 33 designated CDC State Heart
Disease and Stroke Prevention Programs are funded adequately enough to
progress from the planning stage to the implementation stage. This
program's inventive heart disease and stroke reduction/control
programs, particularly among underprivileged Americans, would help to
reduce the incidence and impact of cardiovascular disease as well as to
raise awareness of secondary preventative measures.
The State Heart Disease and Stroke Prevention Program aims to
prevent and control heart disease and stroke risk factors including
high cholesterol and blood pressure. Yet, the program can not reach its
full potential for saving lives and reducing the costs associated with
the disease unless it becomes a fully functioning national program. The
ACC encourages Congress to approve an fiscal year 2005 funding level of
$80 million for the Heart Disease and Stroke Prevention Program at the
CDC. Approving this funding level would guarantee elevation of
additional states from the planning to the implementation stage of
their prevention programs, to continue comprehensively fund those 11
states whose programs are underway in the ``implementation stage,'' and
to supply the states that have yet to begin the planning stage with the
financial means for implementation and establishment of their own State
Heart Disease and Stroke Prevention Programs.
Public Access to AEDs
Since its formal introduction in 1960, cardiopulmonary
resuscitation (CPR) has been the mainstay in close-chest resuscitation
of unresponsive cardiac attack victims. While this method is still an
effective and recommended treatment for helping oxygenated blood reach
the brain and organs, defibrillation through proper use of an AED is
the only sure way to restore the heart's normal rhythm. For people
experiencing sudden cardiac arrest, every minute counts. Unfortunately,
for every minute that passes without defibrillation, a victim's chance
of survival decreases by 7-10 percent. In only 8 or 10 minutes, death
is nearly certain. The price of an AED varies by make and model, but
typically costs around $3,000--a small price when compared with
needless loss of life.
AEDs accurately analyze cardiac rhythms and, if appropriate,
deliver an electric lifesaving countershock. AEDs are widely used by
trained emergency personnel and first responders such as firefighters
and police personnel. Thanks to the growing body of evidence that
``public access defibrillation,'' or PAD, can decrease the amount of
time between cardiac arrest and defibrillation, there has been a
concerted effort to expand public access to AEDs and to improve
training and education on these lifesaving devices. AEDs can now be
found in most high-traffic public areas including schools, shopping
malls, airports and convention centers.
The ACC appreciates Congress' continued attention to the importance
of public access to AEDs with the passage of several legislative
initiatives over the past few years including the ``Automatic
Defibrillation in Adam's Memory Act'' (Public Law 108-41), the ``Rural
AED Act,'' the ``Cardiac Arrest Survival Act,'' and the ``Community
Access to Emergency Defibrillation Act.'' While the ACC appreciates the
Congress' commitment to this important issue, the financial commitment
to Community and Rural AED programs dwindled in the fiscal year 2004
budget despite the urging of the ACC and the AHA. Community and rural
AED programs were grouped together and funded at less than $12 million,
collectively in fiscal year 2004. The ACC is quite concerned that the
benefits brought to communities around the country through increased
access to AEDs could go unrealized if AED programs are not funded at a
higher level in the fiscal year 2005 budget. The ACC, therefore, urges
Congress to fund community and rural AED public access programs at $45
million in fiscal year 2005.
CONCLUSION
The ACC is optimistic about what the future holds for the treatment
and prevention of cardiovascular disease. The potential for work
completed through the NHLBI, the CDC State Heart Disease and Stroke
Prevention Programs, and the AHRQ, is enormous with a strong financial
commitment from this subcommittee. The ACC encourages the subcommittee
to continue its investment in cardiovascular research and educational
programs within the fiscal year 2005 budget and appreciates the
opportunity to share its views on this important topic.
______
Prepared Statement of the National Coalition for Heart and Stroke
Research
My name is Jack Owen Wood. I solicit your support for more
aggressive federal funding for research into prevention and treatment
of the sister diseases, stroke and heart disease. Strokes and heart
attacks are occurring at an alarming rate.
I am representing the National Coalition for Heart and Stroke
Research. The coalition consists of 18 national organizations
representing more than 5 million volunteers and members united in
support for increased funding for heart and stroke research. Members of
the Coalition include: American Academy of Neurology; American Academy
of Physical Medicine and Rehabilitation; American Association for
Vascular Surgery; American Association of Neurological Surgeons;
American College of Cardiology; American College of Chest Physicians;
American Heart Association; American Neurological Association; American
Stroke Association; Association of Black Cardiologists; Citizens for
Public Action on Blood Pressure and Cholesterol, Inc.; Compliment;
Congress of Neurological Surgeons; Mended Hearts, Inc.; National Stroke
Association NASPE/Heart Rhythm Society; Society of Interventional
Radiology; Society for Vascular Surgery; amd WomenHeart: the National
Coalition for Women with Heart Disease.
I will deal primarily with one man's personal experience with
stroke and its functional and financial costs--my own. I have only the
use of my right arm.
I was born in 1937, raised in Vicksburg, Mississippi, earned an
engineering degree at Mississippi State University and currently reside
in Port Orchard, Washington.
I worked for the Boeing Company in Seattle, am a former Director of
the Washington State Energy Office, served as Director of Cost and
Revenue Analysis and as the Forcasting Manager for a major Northwest
Area Natural Gas Utility until May 1, 1995.
On May 1, 1995, at the age of 57, I was stricken and severely
disabled by my stroke. Two years later I experienced a triple bypass
heart operation. You might say I've ``been there and done that'' for
both major cardiovascular diseases. So you see, I am an expert.
Several years ago I was offered an exciting and rewarding volunteer
opportunity. I was asked to lead the ``JACK WOOD STROKE VICTOR TOUR''
for the American Heart Association.
The JACK WOOD STROKE VICTOR TOUR was a 5-state lobbying tour.
Through it I tried to meet personally with every Northwest
Congressional representative on his or her home turf (in Alaska, Idaho,
Montana, Oregon and Washington). In each meeting I was joined by local
people, stroke survivors and their families and medical professionals.
I told my story and asked them to join the Congressional Heart and
Stroke Coalition and to support increased federal funding for heart and
stroke research.
I am proud to say I traveled to 18 communities and met personally
with 28 members of our delegation or their staff. Nearly half of our
congressional delegation is now members of the Congressional Heart and
Stroke Coalition.
One of the most powerful memories for me was the frequency in which
Members of Congress or staff members related their personal experience
with stroke. One member I spoke to lost both parents to stroke. I
suspect many of you have stories too.
I realize your interest is greater than the physical impact of my
stroke. Your concern must include the financial impact, not only to me,
but also on our country from increased health care costs and lost
productivity and its many implications.
I have confronted the difficult and painful task of calculating
that cost to me. Besides being a man whose stroke took his ability to
pick up and play with his grandchildren and his livelihood, I remain a
statistician at heart. I couldn't resist calculating and telling that
part of my story. But please remember my story is not dissimilar to
that of many of the 4.8 million stroke survivors in the United States.
Many of whom were stricken in their prime earning years. Who in a
matter of moments, seemingly without warning, are transformed from a
contributor and provider to a receiver and patient.
Allow me to highlight three figures that I feel sum up my data and
should be important to you. I estimate that my stroke at age 57:
--Reduced my earnings before retirement age 65 by over $600,000.
--Subsequently, the cost to the federal government in lost income and
other taxes, early Medicare payments and Social Security
disability payments is over $320,000.
--My HMO spent approximately $150,000 to respond to and treat my
stroke.
--One man, over $1 million.
About 700,000 Americans will suffer a stroke this year costing this
nation an estimated $54 billion in medical expenses and lost
productivity.
Earlier I described a stroke as occurring seemingly without
warning. All too often as in my case, people either don't know or
ignore the signs of a stroke, even one in progress. When my stroke hit
I denied it. It took me two days after my stroke to acknowledge it and
seek help. Because of research into new treatments, we now have tPA, a
clot-busting drug, which if administered within 3 hours of the onset of
stroke symptoms, can dramatically reduce the damage of clot-based
strokes. Had I recognized and acknowledged my stroke, gone to a
hospital with a neurologist on staff and had there been tPA, the impact
of my stroke most certainly would have been lessened.
What is even more painful to me is that my impending stroke could
have been detected. Unfortunately, we need to create easier and less
expensive diagnostic techniques so that effective diagnostics can be
given routinely as part of regular health exams. And they must be
covered through insurance.
I am not asking for your sympathy. Instead, please think of me as
two of the ghosts in the famous Dickens' story. Please don't
misunderstand, I'm not casting you as Scrooge. See me as both the
ghosts of things past and things yet to be. I too am here to tell you,
the future, which I represent, needs not be. It is largely up to you.
I hope my story and estimate of the cost of my stroke convinces you
that taking on stroke and heart disease through increased research,
leading to better prevention, diagnosis and treatment is fiscally
responsible. The human and financial costs are astronomical.
Thank you for your past support of research.
______
Prepared Statement of the Cooley's Anemia Foundation
SUBJECT
Both Alicia and Michael are Cooley's anemia patients. In their
testimony, they will point to the research successes and the need to
continue the focus on the most scientifically opportune fields of
research. Alicia will describe the tragic impact of the inability of
some patients to comply with the excruciating treatment regimen for the
disease and Michael will request the subcommittee's help in supporting
blood safety surveillance through the CDC and other important research
at the NIH.
ALICIA SOMMA
Good morning, Mr. Chairman. My name is Alicia Somma. Michael
Giammalvo and I both have Cooley's anemia, a fatal genetic blood
disease for which there is currently no cure. Michael is going to
describe to the subcommittee what treatment for Cooley's anemia, or
thalassemia (which is the medical name) is like, and I am going to tell
you the story of my friend Nick who simply could not stand to undergo
the treatment.
MICHAEL GIAMMALVO
Good morning, Mr. Chairman. My name is Michael Giammalvo and I am
13 years old. I was born with Cooley's anemia, which is a fatal genetic
blood disease. Because my body cannot produce red blood cells like most
other people's do, I have to receive a blood transfusion every two
weeks. Getting a blood transfusion that frequently is not fun, but I
have to do it to stay alive.
The problem with this treatment is that it creates a very bad side
effect. When people receive blood transfusions as much as Alicia and I
do, the iron that is in the transfused blood goes into our bodies. The
body does not know how to get rid of it, so it builds up in the heart
and the liver.
To get rid of the iron, patients have to infuse a drug called
Desferal. It is in a pump that we wear. The drug is pumped through a
needle that we have to insert under our skin. Most Cooley's anemia
patients have to infuse Desferal five days a week for 8-12 hours at a
time. The needle hurts. I sometimes can't go to my friends' houses for
sleepovers or do other things that other kids do.
There are times when I really don't want to take the Desferal and I
make it hard on my parents. And, some patients, especially ones who are
a little older than me--teenagers--just stop taking it. Alicia will
tell you about somebody who did that.
ALICIA
Mr. Chairman, this is the first time I have spoken in public about
what happened to my friend Nick Alessi--so please bear with me if this
is a little hard for me.
As a child growing up with this fatal illness, it's difficult not
to feel different. Being the only kid in your class making regular
week-long trips to the hospital, you can't help but feel alone. Nick
made that feeling go away for me. Going to get treated and seeing him
there showed me that I wasn't the only person with Cooley's anemia.
Sitting in that infusion room, he and I became friends, and he made my
life normal.
Constantly updated on each other's health, when I heard Nick hadn't
been compliant with our nightly treatment, I was crushed, almost as if
it had happened to me. Over time, he grew very ill, the overloaded iron
began attacking his heart, and we all knew he was in danger. I spoke
with his father often, giving him advice on how to deal with this
enormous obstacle.
We decided that I should talk to Nick myself, regardless of the
awkwardness I'd feel, because his condition was getting worse everyday.
We arranged to have dinner together and discuss his problems, but
unfortunately, I never got that chance to have that dinner and I never
got the chance to save my childhood friend. We had all tried our
hardest to save Nicholas Alessi, and we all failed. It's just hard to
convince someone that you have to do something so barbaric to yourself
to save your own life. Dealing with this has been immensely difficult,
knowing that it could all be prevented. As I said, Nick was my friend
and now he is gone.
Mr. Chairman, NIH does research on using non-invasive methods of
measuring iron in our livers and hearts and on addressing other related
issues like osteoporosis (which I have even though I am only 18 years
old), hepatitis C (which more than one third of our patients have), and
more. CDC spends $2.2 million to monitor the safety of the blood we
transfuse into our bodies. The FDA is currently reviewing a drug that
might be taken orally to remove iron, rather than the long, painful
infusion but it is still months or years away from being available to
all patients.
Addressing these issues are all things that only the government can
do. And, we would not ask this of our government if it were not so
important. I know that you have a lot of people asking you for a lot of
things today and that you can't do everything. But, Michael and I are
here today to speak on behalf of Nick Alessi--because he can't be here
to speak for himself. Thank you for all you have done and for all you
will do in the future.
We would be pleased to answer any questions.
______
Prepared Statement of the Doris Day Animal League
Chairman Specter, Ranking Member Harkin and Members of the
Subcommittee: The Doris Day Animal League represents 350,000 members
and supporters nationwide who support a strong commitment by the
federal government to research, development, standardization,
validation and acceptance of non-animal and other alternative test
methods. We are submitting our testimony on behalf of the Society for
Animal Protective Legislation, too. Thank you for the opportunity to
present testimony relevant to the fiscal year 2005 budget request for
the National Institute of Environmental Health Sciences for the Center
for the Evaluation of Alternative Toxicological Test Methods (NICEATM)
for the Interagency Coordinating Committee for the Validation of
Alternative Test Methods (ICCVAM) activities for fiscal year 2005.
In 2000, the passage of the ICCVAM Authorization Act into Public
Law 106-545, created a new paradigm for the field of toxicology. It
requires federal regulatory agencies to ensure that new and revised
animal and alternative test methods be scientifically validated prior
to recommending or requiring use by industry. An internationally agreed
upon definition of validation is supported by the 15 federal regulatory
and research agencies that compose the Interagency Coordinating
Committee for the Validation of Alternative Methods (ICCVAM), including
the EPA. The definition is: ``the process by which the reliability and
relevance of a procedure are established for a specific use.''
FUNCTION OF THE ICCVAM
The ICCVAM performs an invaluable function for regulatory agencies,
industry, public health and animal protection organizations by
assessing the validation of new, revised and alternative toxicological
test methods that have interagency application. After appropriate
independent peer review of the test method, the ICCVAM recommends the
test to the federal regulatory agencies that regulated the particular
endpoint the test measures. In turn, the federal agencies maintain
their authority to incorporate the validated test methods as
appropriate for the agencies' regulatory mandates. This streamlined
approach to assessment of validation of new, revised and alternative
test methods has reduced the regulator burden of individual agencies,
provided a ``one-stop shop'' for industry, animal protection, public
health and environmental advocates for consideration of methods and set
uniform criteria for what constitutes a validated test methods. In
addition, from the perspective of animal protection advocates, ICCVAM
can served to appropriately assess test methods that can refine, reduce
and replace the use of animals in toxicological testing. This function
will provide credibility to the argument that scientifically validated
alternative test methods, which refine, reduce of replace animals,
should be expeditiously integrated into federal toxicological
regulations, requirements and recommendations.
HISTORY OF ICCVAM
The ICCVAM is currently composed of representatives from the
relevant federal regulatory and research agencies. It was created from
an initial mandate in the NIH Revitalization Act of 1993 for NIEHS to
``(a) establish criteria for the validation and regulatory acceptance
of alternative testing methods, and (b) recommend a process through
which scientifically validated alternative methods can be accepted for
regulatory use.'' In 1994, NIEHS established the ad hoc ICCVAM to write
a report that would recommend criteria and processes for validation and
regulatory acceptance of toxicological testing methods that would be
useful to federal agencies and the scientific community. Through a
series of public meetings, interested stakeholders and agency
representatives from all 14 regulatory and research agencies, developed
the NIH Publication No. 97-3981, ``Validation and Regulatory Acceptance
of Toxicological Test Methods.'' This report, and subsequent revisions,
has become the sound science guide for consideration of new, revised
and alternative test methods by the federal agencies and interested
stakeholders.
After publication of the report, the ad hoc ICCVAM moved to
standing status under the NIEHS' NICEATM. Representatives from federal
regulatory and research agencies and their programs have continued to
meet, with advice from the NICEATM's Advisory Committee and independent
peer review committees, to assess the validation of new, revised and
alternative toxicological methods. Since then, several methods have
undergone rigorous assessment and are deemed scientifically valid and
acceptable. In addition, the ICCVAM is working to streamline assessment
of methods from the European Union (EU) that have already been
validated for use within the EU. The open public comment process, input
by interested stakeholders and the continued commitment by the federal
agencies has led to ICCVAM's success. It has resulted in a more
coordinated review process for rigorous scientific assessment of the
validation of new, revised and alternative test methods.
REQUEST FOR APPROPRIATIONS
On December 19, 2000, the ``ICCVAM Authorization Act'' which makes
the entity a permanent standing committee, was signed into Public Law
No. 106-545. For several years, the NIEHS has provided between $1 and
$2.6 million per fiscal year to the NICEATM for ICCVAM's activities. In
order to ensure that federal regulatory agencies and their stakeholders
benefit from the work of the ICCVAM, it is important to fund it at an
appropriate level. I respectfully urge the Subcommittee to support and
appropriation for the NIEHS' NICEATM for ICCVAM's activities at $3.5
million for fiscal year 2005. This appropriation request includes all
FTEs, funding for independent peer review assessment of test methods
and meetings of the ICCVAM and other activities as deemed appropriate
by the Director of the NIEHS.
REQUEST FOR COMMITTEE REPORT LANGUAGE
I also respectfully request the Subcommittee consider the following
report language for the Senate Labor, Health and Human Services,
Education and Related Agencies Appropriations bill:
``The Committee supports the assessment of scientific validation of
new, revised and alternative toxicological test methods by the ICCVAM.
The Committee urges the fifteen regulatory and research agencies
composing the ICCVAM to use the expertise and credibility of the ICCVAM
for assessments to obviate their individual consideration of new,
revised and alternative test methods. The Committee also urges the
regulatory and research agencies to incorporate scientifically
validated new, revised and alternative test methods into their
regulations, requirements and recommendations in an expeditious
manner.''
Thank you for the opportunity to submit this request on behalf of
the Doris Day Animal League and the Society for Animal Protective
Legislation.
______
Prepared Statement of the Jeffrey Modell Foundation
SUBJECT
Mrs. Modell will, first and foremost, thank the committee and its
members for its past assistance and support. She will also testify in
favor of increases in funding for the National Institutes of Health
(NIH) and the Centers for Disease Control and Prevention (CDC).
Concerning CDC, she will request an increase in the current program
that provides funding for a national education and awareness program
related to primary immunodeficiency diseases to allow the Foundation to
expand the program to reach underserved African-American and Hispanic
communities. Within NIH, her testimony will focus specifically on
NICHD, NIAID and NHLBI.
Mr. Chairman and Members of the Subcommittee: Thank you for the
opportunity to testify before you today. I am Vicki Modell and, along
with my husband Fred, we created the Jeffrey Modell Foundation in 1987
in memory of our son, who died at the age of 15 as a result of a life
long battle against one of the 100-plus primary immunodeficiency
diseases.
First and foremost, Mr. Chairman, I am here today to thank you and
all the members of this committee on both a personal and a professional
level. Personal because whenever Fred and I come to Washington, whether
it is to testify here before the committee or to meet with the members
of the subcommittee individually in their offices, every Member of
Congress and every member of your staffs are unfailingly polite,
courteous, interested and caring.
And, professional because over the last seven years that we have
been coming to Washington, we have been given the opportunity to build
a partnership with the Congress, the Centers for Disease Control and
Prevention, the National Institutes of Health, as well as with our own
supporters in the private sector, including industry and other
concerned donors.
We believe that we have maximized the benefits for patients from
the support that this subcommittee has afforded us. We are going to
tell you a remarkable story of success, of hope, and of future
challenges this morning.
This subcommittee is currently funding CDC with $2.2 million for
physician education and public awareness of immune deficiencies. The
Jeffrey Modell Foundation operates the program under a contract with
CDC. Although we only receive about $1.8 million of the money (CDC
keeps the rest for its ``administrative expenses''), we have leveraged
that money into a $15 million national campaign.
The Foundation has raised more than $1.0 million, largely from our
supporters in the pharmaceutical and blood-related industries. Working
with the Ad Council and a major New York City ad firm, we put together
a media campaign alerting families to the possibility that repetitive
infections may indicate a deeper, underlying problem and explaining to
parents how to get their children tested. That campaign has generated
more than $12 million in donated media time on television and radio, as
well as magazine ad space.
But, the campaign has been even more than the advertising.
--We have conducted physician symposia for CME credit all over the
country.
--Working with NIH, we have produced educational materials for
doctors and families. We have mailed 38,000 posters--one to
every school nurse in the United States.
--NICHD has mailed information to every member of the American
Academy of Pediatrics and the American Academy of Family
Practice.
--We have developed and improved a terrific website.
All of these steps would not be possible without the support of
this subcommittee, but there is so much more that we can do.
We fully recognize what a difficult appropriations year this is
going to be. We know that, like every year, the demands on the
subcommittee far exceed the allocation that you will likely have
available. We also understand that our needs are small in the bigger
picture of funding multi-billion programs like Pell Grants or the No
Child Left Behind program. Yet, we have taken a small amount of money--
for which we are eternally grateful--and generated $7 of private money
for every $1 of government money.
Mr. Chairman, one of the great unmet needs in our education and
awareness program is underserved African American and Hispanic
populations. Any such program concerning an undiagnosed disease needs
to make special provisions for reaching these groups. You need to seek
time on different radio stations, different television networks, and
space in different magazines.
Yet we know that this must be done. If you visit the Emergency Room
at our home hospital in New York--Mount Sinai--then you visit the
infusion room operated by the Department of Immunology, you see two
very different populations. Yet the research tells us that there is not
an ethnic component to this disease. That means that the visible
differences relate to our medical system, not the incidence of disease.
We are prepared to take on this challenge, much as this Congress
has been willing to address the problems of health disparities through
the NIH and elsewhere. We believe that we can begin to make a dent in
the problem by increasing the funding available for this program to
$2.7 million from $2.2 million.
Mr. Chairman, as you know, we have other interests within the
purview of this committee, as well. We have along history of
collaboration with NICHD, which has been our strongest supporter under
the able leadership of Dr. Duane Alexander. We have helped to fund
research at NIAID. We have funded post-doctoral fellows at NHGRI. We
are now jointly funding a conference with NHLBI.
Our interactions with these many NIH institutes has convinced us
that further increases in their budget--to whatever level fits within
your allocation--will be put to good use and will benefit chronically
ill people like our patients.
Mr. Chairman, as I said in the beginning of my remarks, Fred and I
are very grateful. We cannot begin to thank you and the subcommittee
enough for all of the support and encouragement that we have received
from you whenever we come to Washington. While we may never be able to
repay all your kindnesses, you should know that the work that you do
enables the work that we do. And, every young person who is diagnosed--
early and properly--and then receives treatment is a young person who
life is better for what you have done.
Thank you again. I would be pleased to answer any questions.
______
Prepared Statement of the American Association for Dental Research
SUMMARY
Dental research is concerned with the prevention, causes,
diagnosis, and treatment of diseases and disorders that affect the
teeth, mouth, jaws, and related systemic diseases. Dental health is an
important, vital part of health throughout life.
INTRODUCTION
I am Dr. Michael Alfano, Dean of the New York University School of
Dentistry. This testimony I am presenting is on behalf of the American
Association of Dental Research (AADR). The AADR is a non-profit
organization with over 5,000 individual members and 100 institutional
members within the United States. AADR's mission is to enhance the
quality and scope of oral health, advance research and increase
knowledge for the improvement of oral health, and increase
opportunities for scientific changes.
Mr. Chairman and members of the Committee, we want to thank you for
this opportunity to testify about the exciting advances in oral health
sciences. I would like to discuss our fiscal year 2005 budget
recommendations for the National Institute of Dental and Craniofacial
Research (NIDCR).
OVERVIEW
Oral health is an important component of health. Good teeth and
healthy gums for chewing and appearance, as well as taste buds and
saliva to enjoy food and facilitate speech, all make major
contributions to quality of life. Over the years, discoveries stemming
from dental research have reduced the burden of oral disease for many
Americans--although much remains to be done to reduce further the
prevalence of oral diseases and their impact on overall health and
well-being, as identified in Surgeon General (SG) David Satcher's
Report of 2002: Oral Health in America and reinforced by current SG
Richard Carmona in his 2003 National Call to Action to Promote Oral
Health.
Of even broader interest, however, the oral cavity also offers
intriguing potential as a diagnostic window to the rest of the body--
potential being pursued by the National Institute of Dental &
Craniofacial Research (NIDCR). In fact, the Director of the National
Institutes of Health, Dr. Elias Zerhouni, believed the potential for
salivary diagnostics was so promising that he allocated some of his
discretionary funds toward this research. Dr. Zerhouni has also
complimented the NIDCR for its salivary research as exemplifying the
type of interdisciplinary research that will be necessary to improve
overall health outcomes for patients.
SALIVA AS A DIAGNOSTIC AND MONITORING TOOL
Saliva is the protective fluid of the oral cavity. With its vast
supply of microbe killers, saliva combats invading pathogens such as
HIV and a host of bacteria associated with oral and systemic diseases.
Antibodies directed against pathogens, such as polio and cold viruses,
are found in saliva. Large salivary glycoproteins, called mucins,
appear to have antiviral properties as well.
Oral fluid is also a mirror of the body, containing many compounds
indicating a person's health and disease status and, like blood and
urine, its composition may be altered in the presence of disease.
Saliva, however, may be collected in a much less invasive fashion than
either blood or urine.
Technologies are being developed at the NIDCR and by
multidisciplinary teams in universities supported by grants from the
NIDCR. These technologies offer huge clinical and commercial
opportunity and may one day catalyze a shift in our current health
system of disease detection to real-time health surveillance. For
example:
--Studies have uncovered in saliva the presence of a cancer-related
protein whose concentration increases in the presence of breast
cancer--a potential diagnostic marker for the early detection
of breast cancer in women.
--Saliva is gaining value as a diagnostic aid and potential monitor
of disease progression in systemic disorders, including
Alzheimer's disease, Sjoren's syndrome (an important autoimmune
disease), cystic fibrosis, and diabetes.
--Saliva is also proving to be an effective tool to monitor levels of
hormones and therapeutic medications.
--Research opportunities abound to develop more sensitive and
specific assays to measure and understand changes in saliva
beyond oral and systemic diseases in areas such as genetic
defects, nutritional status, and age-specific changes.
GENE THERAPY USING SALIVARY GLANDS
Gene therapy, substituting effective genes for those that are
missing or nonfunctional and not producing needed proteins, offers hope
for many patients, especially those who have conditions caused by a
deficiency in a single protein, such as Type I diabetes, growth hormone
deficiency, and hypoparathyroidism. Many of the difficulties involved
in the delivery of such genes to internal organs can be avoided by
incorporating functioning genes into salivary glands, which can in turn
make the deficient protein and provide therapeutic benefit. If
resources become available, the NIDCR is proposing an evaluation of
gene transfer techniques in three clinical trials, involving patients
with:
--adult growth hormone deficiency,
--chronic renal failure, and
--Sjoren's syndrome and salivary gland damage.
BIOMIMETICS/TISSUE ENGINEERING
Advances in the design of materials and an increasing understanding
of mechanisms by which tissues of the craniofacial complex develop have
positioned scientists to replace tissues lost as a result of
developmental defects, pathology, or trauma. Interdisciplinary teams of
scientists supported by the NIDCR:
--continued to improve dental restorative and implant materials;
--identified mechanisms to address osteoporosis and other conditions
by making one cell type become another, e.g., inducing more
bone marrow cells to become bone cells rather than fat cells;
--discovered that the ``baby teeth,'' which children begin to lose
normally around age six, contain a rich supply of stem cells
that may have more potential for differentiation into other
cell types than do adult stem cells, and are identifying these
other cell types as funding permits; and
--created a distinct portion of the lower jaw from rat adult stem
cells that is the precise three-dimensional shape of the human
mandibular joint.
Researchers have long dreamed of engineering new teeth, knees,
hips, and other body parts from a person's own tissues. Research to
date has provided a solid base for making this dream a reality. Noting
the ease of access to the oral cavity, Dr. Bruce Baum, a scientist at
the NIDCR, has noted that ``the mouth is one of the best laboratories'
in the body to study issues in human biology that go beyond dental
research.''
RESEARCH IN PATIENT CARE SETTINGS
In November 2003, the NIDCR announced support for Dental Practice-
Based Research Networks (PBRNs) to provide an infrastructure for
answering important clinical questions routinely faced by dental
practitioners (http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-05-
006.html). Indeed, the 2002 American Dental Association Future of
Dentistry report specifically recommends that national clinical
research networks be established that link treatment approaches and
outcomes in private practice settings.
By connecting community-based dental providers with experienced
clinical investigators, PBRNs will enhance clinical research supported
by the NIDCR and produce findings that are immediately relevant to
practitioners and their patients. Because research is conducted in the
real-world environment of dental practice, results may be more readily
accepted by practitioners and rapidly integrated into dental practice.
Importantly, PBRNs also provide a very cost-efficient mechanism for
conducting clinical studies, because they use existing personnel and
the infrastructure of established dental practices.
RECOMMENDATION
The National Institute of Dental and Craniofacial Research (NIDCR)
is the leading agency supporting research in the oral and craniofacial
area. NIDCR has already begun investing in all of the above areas, but
the Institute needs additional funding if these initiatives are to
become a reality. It is requested that an appropriation of $420,000,000
be provided for NIDCR in fiscal year 2005 to launch a major initiative
to complete the development of the technology for using saliva as a
low-cost, non-invasive, diagnostic instrument; to pursue gene therapy
using the salivary glands; to accelerate efforts in biomaterials and
tissue engineering (regeneration of teeth and other body parts); and to
develop fully the recently announced Dental Practice-based Research
Networks initiative.
In fiscal year 2005, the AADR also supports an appropriation of
$30.6 billion for the NIH overall, $20,000,000 for CDC's Division of
Oral Heath, $182,000,000 for the CDC's National Center for Health
Statistics, and $443,000,000 for the Agency for Healthcare Research &
Quality.
______
Prepared Statement of the Society for Maternal-Fetal Medicine
Mr. Chairman and Members of the Committee, I am James Ferguson,
M.D., President of the Society for Maternal-Fetal Medicine. We
appreciate the opportunity to testify before this Committee and are
most appreciative of the support you have provided over the years to
the National Institutes of Health, in particular the National Institute
of Child Health and Human Development.
The Society for Maternal-Fetal Medicine (SMFM), established in
1977, is a subspecialty organization, which was formed to promote
research and education on issues that may confront a high-risk pregnant
mother or unborn fetus. The SMFM has a very strong interest in
improving pregnancy outcome through basic, translational and clinical
research. Only through research can complications involving the mother
or unborn fetus be understood, treated, prevented, and eventually
solved.
Maternal-Fetal Medicine is a subspecialty within Obstetrics and
Gynecology. Maternal-Fetal Medicine subspecialists pursue an additional
2 to 3 years of fellowship training following completion of their 4
year residency program in Obstetrics and Gynecology. Maternal-Fetal
Medicine subspecialists provide consultative services to obstetricians,
while in other cases they actually assume direct care responsibility
for the special problems that high-risk mothers or high- risk fetuses
face. The special problems faced by these mothers may lead to death,
short-term or in some cases life-long problems for their babies. For
example:
--Preeclampsia.--Preeclampsia is a dangerous condition characterized
by high blood pressure and the presence of protein in the
urine. It complicates 3 to 4 percent of pregnancies, strikes
without warning and is a leading cause of maternal and fetal
death. In some cases, the condition may progress to eclampsia,
a series of potentially fatal seizures. Although the high blood
pressure and seizures can be treated, the only cure for
preeclampsia is delivery of the baby. Surviving infants are at
increased risk for preterm birth, may be undergrown or have
serious disorders requiring neonatal intensive care.
--Preterm Birth.--Preterm birth (Premature delivery) complicates
approximately 10 percent of births and is a direct contributor
to over 75 percent of the infant deaths and substantial newborn
mortality and morbidity. Despite decades of committed research,
the physiologic mechanisms underlying the onset of the process
of giving birth, either preterm or term, have yet to be clearly
identified.
--Stillbirth.--When fetal death occurs after 20 weeks or more
gestation, it is referred to as stillbirth. For many parents
who hear the heartbreaking news that their baby has died in the
womb, the loss is completely unexpected. Half of all
stillbirths occur in pregnancies that appear to be problem-
free. While 14 percent of fetal deaths occur during labor and
delivery, 86 percent of fetal deaths occur before labor begins.
The only warning the pregnant woman may have that there is a
problem is that the baby suddenly is no longer moving or
kicking. The most common known causes of stillbirth include:
placental problems, birth defects, growth restriction and
infections. But for at least half of all stillbirths, the cause
remains undetermined. Despite the significant and persistent
burden of stillbirth, the phenomenon has remained largely
unstudied.
--Abnormal fetal growth.--Abnormalities in the regulation of fetal
growth may result in newborns that are significantly overgrown
or undergrown and suffer complications related to the abnormal
growth pattern. Inadequate fetal growth may occur in the
absence of recognized causes e.g., maternal hypertension,
smoking, or inadequate nutrition, and may be associated with
intrauterine fetal demise or immediate neonatal and long-term
consequences for the infant. Excess fetal growth may occur in
pregnancies complicated by maternal obesity or diabetes,
despite appropriate nutritional counseling and insulin therapy.
Currently the management of under-and overgrown fetuses is
empirical, aimed primarily at selection of safest time for
delivery. There are no effective treatments to prevent or
reverse either intrauterine growth restriction or fetal
macrosomia.
--Neonatal brain injury.--The precise cause of the majority of cases
of neonatal brain injury is unknown. In the past, much emphasis
was placed on hypoxia and ``asphyxia'' as a cause. Recent
studies suggest that maternal infection and subsequent fetal
infection may play a major role in the causation of newborn
brain abnormalities such as periventricular leukomalacia and
white matter damage.
The National Institute of Child Health and Human Development
(NIHCD) has been a leader in the field of maternal-fetal medicine
research. Its commitment to basic, clinical and translational research
has lead to new ways to treat and improve the health of pregnant women
and infants. In the 1960's the birth weight at which infants had a 50-
percent change for survival was approximately three (3) pounds; today
it is 1\1/2\ pounds. Research conducted and supported by the NICHD, has
given preterm infants and their families hope for the future.
RECENT ACCOMPLISHMENTS
NICHD supported research in maternal-fetal medicine has been
dramatic. Great strides are being made in our understanding of
pregnancy and its complications. Recent researching findings revealed
that:
--abnormal levels of two molecules found in the blood appear to
predict the development of preeclampsia. This observation is
the most promising lead yet in the pursuit of this life-
threatening disorder. If the development of preeclampsia can be
reliably predicted, treatment strategies may be developed
before more serious problems arise.
--women with heightened resistance to the hormone ``insulin'' in the
early months of pregnancy are at risk to develop preeclampsia.
This finding suggests that physicians may be able to initiate
preventive measures early in a pregnancy for women with insulin
resistance. The research also implicates insulin resistance as
a causative factor in preeclampsia; thus, it may ultimately be
possible to prevent preeclampsia by improving insulin
sensitivity in at-risk women early in a pregnancy or even
before conception.
--an anti-diabetes drug, metformin, lowered the risk of a miscarriage
in the first trimester of pregnancy for women with polycystic
ovary syndrome (PCOS). The investigators had already
demonstrated that the drug increases blood flow in the uterus
and brings about changes in the uterine lining.
MATERNAL FETAL MEDICINE UNITS NETWORK
The National Institute of Child Health and Human Development
created the Maternal Fetal Medicine Units Network (MFMU) in 1986 to
address major clinical questions in maternal fetal medicine and
obstetrics, particularly with respect to the continuing problem of
preterm birth. The Network supports 14 clinical academic institutions
and one data center. Typically, the network has four to six studies
and/or trials ongoing at any given time. This approach provides optimal
efficiency and cost-effective research. Over the last year, two trials
studying progesterone for the prevention of preterm birth in high-risk
women and Factor V Leiden mutations have been completed. This research
will benefit countless women at risk of preterm birth.Over the last
year, a trial on the identification of a therapy, progesterone, that
prevents recurrent preterm birth in high-risk women has been completed.
This is one of the first advances in this area, despite extensive
efforts over decades.
Areas of Need
NICHD is at the forefront of several novel and important research
areas, but there are still many areas that we are not close to
understanding about maternal health, pregnancy, fetal well-being, labor
and delivery and the developing child.
--The next major advance in elucidating the etiology of preterm
delivery involves understanding the mechanism through the
evaluation of protein and gene expression. These techniques are
widely used in other medical fields, and it is imperative that
they are used to understand prematurity. Through these new
technologies, wide scale, high output genomic and proteomic
strategies should be used to identify mechanisms underlying
premature birth.
--New tools are needed to assess fetal growth; and non-invasive
methods to assess changes in the uterine cervix and muscle
(myometrium), and placental changes over time.
--Research should focus on the pre-pregnancy and early pregnancy
periods; the role of the cervix; the role of the placenta,
including functional mechanisms related to pregnancy outcomes
and fetal well-being, such as fetal growth and preterm
delivery.
--Strategies for predicting preterm birth should include multivariate
analysis, such as that used in neural network analysis, and
should focus on identifying the potentially reversible changes
that take place prior to and during the early phase of
pregnancy.
--Research should focus on the cases with highest mortality and
morbidity and should not be diluted by inclusion of less
relevant cases of preterm birth that are close to term.
--Research is needed to:
--develop clinical methods to identify pregnancies where delaying
delivery is futile or in some cases detrimental.
--determine the effects of intervention on outcome.
--identify the risk factors for adverse outcomes arising as result
of pre-eclampsia, (abruption, preterm birth) in
hypertensive women.
--Understand the pathophysiologic abnormalities that lead to
adverse pregnancy outcome in hypertensive women.
--Research is needed to explain the exact mechanism of how infections
lead to brain injury at various stages of pregnancy and brain
development. In addition, delineation of the biochemical
pathyway leading to injury may allow for interventions before
irreversible injury occurs.
RECOMMENDATIONS
Without a sustained and continued investment in the areas of need,
the health of pregnant women and their babies will continue to be at
risk. The SMFM therefore recommends:
--An increase of 10 percent in fiscal year 2005 for the National
Institutes of Health, bringing its total budget to $30.6
billion, as supported by the Ad Hoc Group for Medical Research
Funding.
--An increase of 10 percent or $1.366 billion in fiscal year 2005 for
the National Institute of Child Health and Human Development.
--NICHD fully support the MFMU Network so that it can continue to
address important research questions, with an emphasis on
issues pertaining to preterm births and low birth weight
deliveries.
--That the NICHD have a major initiative to focus on genomics and
proteomics to hasten a better understanding behind the
pathophysiology of premature birth, discover novel diagnostic
biomarkers, and ultimately aid in formulating more effective
interventional strategies to prevent premature birth.
--That the NICHD fully fund the cooperative network of clinical
centers and data center to study stillbirth.
Thank you Mr. Chairman and Members of the Committee for the
opportunity to express our concerns and recommendations before this
Committee.
______
Prepared Statement of the National Coalition for Osteoporosis and
Related Bone Diseases
Mr. Chairman and Members of the Committee: I am Joan Goldberg,
Executive Director of the American Society for Bone and Mineral
Research. I am here today on behalf of the National Coalition for
Osteoporosis and Related Bone Diseases (the Coalition). We want to
thank you for your continued support of the National Institutes of
Health. Without your support the scientific achievements that have
translated into direct benefits for millions of Americans afflicted
with bone diseases such as Osteoporosis, Osteogenesis Imperfecta and
Paget's disease of bone could not have been possible.
The participants of the Coalition are the National Osteoporosis
Foundation, the American Society for Bone and Mineral Research, the
Paget Foundation for Paget's Disease of Bone and Related Disorders and
the Osteogenesis Imperfecta Foundation. The Coalition is committed to
reducing the impact of bone diseases through expanded basic, clinical,
epidemiological, and behavioral research and through education leading
to improvements in patient care.
What do we know about bone? One misconception is that bone is a
static tissue. Bone is a living tissue that makes up the body's
skeleton. It is a truly remarkable structural material, which makes it
ideal for its function of structural support. Bone provides mobility,
protection of vital organs, and housing of the bone marrow. It is also
a reservoir for calcium. This dynamic and highly tuned organ
simultaneously balances growth to achieve strength and resilience, and
repair without overgrowth. This balance is achieved by bone remodeling.
An imbalance in remodeling, however, leads to the debilitating bone
diseases such as osteoporosis, paget's disease of bone and osteogenesis
imperfecta. These diseases are responsible for a large portion of
healthcare expenditures in the United States. For example:
--OSTEOPOROSIS, or porous bone, is a disease characterized by low
bone mass and structural deterioration of bone tissue, leading
to bone fragility and an increased susceptibility to fractures
of the hip, spine, and wrist. It is a major public health
threat for 44 million Americans. Of the 10 million who have
osteoporosis, 80 percent are women. Today, 2 million men have
osteoporosis and almost 12 million more are at risk for the
disease. Men with low levels of testosterone are especially at
risk. This includes men being treated with certain medications
for prostate cancer. Osteoporosis is responsible for more than
1.5 million fractures annually, including over 300,000 hip
fractures; 700,000 vertebral fractures; 250,000 wrist
fractures; and 300,000 fractures at other sites. The estimated
national direct expenditures (hospital and nursing homes) for
osteoporotic and associated fractures were $17 billion in 2001
($47 million each day) and the cost is rising.
--PAGET'S DISEASE OF BONE, the second most prevalent bone disease
after osteoporosis, is a chronic skeletal disorder that may
result in enlarged or deformed bones in one or more regions of
the skeleton. Excessive bone breakdown and formation can result
in bone that is dense, but fragile. Complications may include
arthritis, fractures, bowing of limbs, and hearing loss if the
disease affects the skull. Prevalence in the population ranges
from 1.5 percent to 8 percent depending on the person's age and
geographical location. Paget's disease primarily affects people
over 50.
--OSTEOGENESIS IMPERFECTA (OI) causes brittle bones that break easily
due to a problem with collagen production. For example, a cough
or sneeze can break a rib, rolling over can break a leg. There
are four recognized types of OI, representing extreme
variations in severity and affecting 20,000 to 50,000 people in
the United States. In severe cases fractures occur before and
during birth. Undiagnosed OI may result in accusations of child
abuse. Besides fragile bones, people with OI may have hearing
loss, brittle teeth, short stature, skeletal deformities, and
respiratory difficulties.
--FIBROUS DYSPLASIA is a chronic disorder of the skeleton, which
causes expansion of one or more bones due to abnormal
development of fibrous tissue within the bone. Any bone can be
affected, and involvement can be in one or several bones.
Though many bones can be affected at once, fibrous dysplasia
does not spread from one bone to another. At present there are
no approved medical therapies. Surgery is sometimes recommended
for severe complications.
Another bone-related complication of bone that must be called to
your attention is bone metastasis (cancer spreading to bone). Bone
metastasis is a frequent complication of cancer and occurs in up to 70
percent of patients with breast cancer and prostate cancer, and in
approximately 15 to 30 percent of patients with lung, colon, stomach,
bladder, uterine, rectal, and renal cancer. Bone metastases cause
severe pain and fracture and once tumors spread to bone, they are
incurable.
Federal funding appropriated by the Congress has allowed the
National Institutes of Health to conduct and support research that has
reduced the adverse impact of bone disease on quality of life. Research
has--
--taught us how many Americans have low bone mass and therefore are
at risk for osteoporosis. These individuals can now address
their risk with exercise, diet, other behavioral and lifestyle
changes, and medication, as appropriate.
--demonstrated that a variety of drugs currently available can reduce
bone loss and fractures, and even build bone.
--led to a better understanding of calcium metabolism and, as a
result, manufacturers of a variety of food products have
fortified their products with this vital nutrient.
--identified the necessity of vitamin D, protein, iron, etc., in
addition to calcium in building and maintaining strong bones,
while also spotlighting the major public health problem of
vitamin D deficiency.
--helped us to understand the need for weight-bearing exercise to
build and maintain bone density and strength training to
increase balance and flexibility to reduce falls.
--identified a genetic component in many bone diseases, paving the
way for the development of genetic approaches to diagnosis and
treatment.
--decreased fracture risk and extended the lifespan for children with
OI.
It is apparent that the quality of life related to bone disease is
improving for many Americans, but much still remains to be achieved in
areas such as:
DIAGNOSTICS/IMAGING
--DXA is an imaging test that measures bone mineral density (BMD). It
is the gold standard for predicting fracture risk, yet it may
both under-diagnose and over-diagnose patients at risk.
Moreover, DXA uses databases that are largely based on BMD
scores of white women. Relating BMD scores to fracture risk for
women of other racial groups and ethnicities--and doing the
same for men--is even more imprecise.
--New diagnostic measures are required to predict fragility and
fracture risk better through assessing skeletal strength three
dimensionally, focusing on internal bone micro-architecture or
structure.
TREATMENT/PHARMACOTHERAPY
--Much attention has been focused on the Women's Health Initiative
study results and the risks involved in estrogen treatment.
However, more information is needed about low-dose estrogen and
its bone-protective benefits and risks.
--Most current drug treatments for osteoporosis work by slowing down
the natural process of bone breakdown. PTH, a hormone, actually
builds bone. However, we need more studies to learn how best to
use the drugs currently available, for what populations, with
or after what drug regimens, for how long, and how best to
assess response and interaction with exercise and diet.
--The discovery of new molecules with unexpected roles in modulating
bone mass points the way to development of other new therapies.
One example is leptin, a molecule made by fat cells.
--A 5-year observational study suggested that regular intravenous
doses of pamidronate (a bisphosphonate) helped increase bone
mineral density, reduce fractures, increase mobility, and
decrease bone pain in children with osteogenesis imperfecta.
Controlled clinical drug therapy trials will enable assessment
of the potential use of bisphosphonate drugs to improve quality
of life for children and adults.
--The discovery that tumor cells increase the number of natural-
occuring cells that destroy bone has improved treatment and
quality of life for patients with bone metastases through the
use of drugs called bisphosphonates. However, further research
is needed to study the path of bone disease in breast cancer,
prostate cancer, multiple myeloma, and other cancers that
spread to bone.
--Research is needed to improve survival and quality of life and to
prevent metastatic osteosarcoma for the approximately 600
children and teenagers in the United States who develop this
cancer. Specifically, research is needed to:
--Identify new intervention targets for therapy;
--Develop better predictors of response to osteosarcoma treatment;
--Develop in vivo and in vitro preclinical assays to improve
treatment;
--Study metastatic osteosarcoma biology compared to biology of
normal bone cells and that of other cancer cells.
NOVEL APPROACHES
--Investigations into genetic approaches for bone disease are
critical and stem from recent findings that bone doesn't form
when one protein--Cbfa-1--is missing. Understanding how this
protein is activated or turned on may lead to new therapies for
bone disease.
--The identification and study of families with very high bone mass
who never fracture have led to the discovery of the involvement
of the ``wnt pathway'' in regulating bone mass. This pathway
has not only become a potential therapeutic target for
controlling skeletal mass, but has recently been implicated in
the bone loss experienced in multiple myeloma (a bone- and
blood-related cancer).
--Understanding the role of genes and the underlying abnormal
functioning of cells involved in bone breakdown in patients
with Paget's disease is critical to developing new treatments.
We need additional investigation to understand the role the
bone microenvironment plays in the development of Paget's
disease and to identify the molecular processes involved.
--Bone marrow transplantation is being tested in the laboratory for
the treatment of osteogenesis imperfecta. One technique
requiring further development focuses on genetically
engineering bone precursor cells, which reside in the bone
marrow, so that the faulty osteogenesis imperfecta gene which
causes frequent fractures would be blocked or turned off. Then
these engineered cells could be transplanted back into the bone
marrow to form healthy bone.
--The use of specific exercise regimes--such as jumping--in the
growing child, and of vibrating devices, for adults, represent
exciting avenues for continued exploration into low-cost
approaches to strengthen bone.
--The potential for genetic therapy to cure osteogenesis imperfecta
has been demonstrated in the test tube. Suppressing the gene
that causes the mutant collagen must now be demonstrated in
animal models.
Bone research must be considered a trans-NIH issue given that bone
diseases can lead to or be linked to other diseases such as cancer.
Studies are currently being supported and conducted by the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (the lead
institute for bone research), the National Institute on Aging, the
National Institute of Diabetes and Digestive and Kidney Diseases, the
National Institute of Child Health and Human Development, the National
Institute of Dental and Craniofacial Research and the National Cancer
Institute.
Mr. Chairman and members of the committee we are most appreciative
of your past support for the programs of the National Institutes of
Health. The momentum in research cannot stop. The American people are
expecting and holding fast to the hope that one day cures will be found
for the debilitating diseases of bone.
RECOMMENDATIONS
The National Coalition for Osteoporosis and Related Bone Diseases
believe that improved treatments and a cures are in sight, but greater
federal funding will be necessary if these advances are to be achieved.
The Coalition, therefore:
--Joins the Ad Hoc Group for Medical Research Funding in urging the
Committee to provide an appropriation of $30.6 billion in
fiscal year 2005 for the National Institutes of Health--an
increase of 10 percent.
--Supports the NIAMS Coalition recommendation of a 10 percent
increase for the National Institute of Arthritis and
Musculoskeletal and Skin Diseases, the lead bone research
institute.
--Supports increased funding for NIA, NIDCR, NIDDK, NCI, and NICHD,
other Institutes that also fund bone-related research, as well
as seeks additional support for bone programs at NIBIB and
NCAM.
--Requests more funding for training, transitional grants and debt
repayment programs for young investigators and clinical
scientists.
Mr. Chairman, thank you for the opportunity to testify before this
Committee.
______
Prepared Statement of the American Association for Cancer Research
The American Association for Cancer Research (AACR) is the world's
oldest, largest, and most prestigious professional society of cancer
scientists and clinicians. The AACR embraces the mission of our 22,000
members to advance the prevention, detection, control and cures of
cancer through research, education, and communication.
The AACR is the authoritative voice for those who constitute a
continuum of cancer research. It is the work of those within this
continuum that contributed to reduced death rates and stabilized
incidence in lung, breast, prostate and colorectal cancers during the
last decade. The effort to contain cancer is achievable, and the
progress we have made is encouraging for the future.
Research by members of the AACR will lead to new ways of
preventing, controlling and curing cancers in people of all ages.
Scientists are mining information from the Human Genome Project to
discover how cells use genetic information to become cancers.
Researchers are identifying the genes that cause cancer and are
designing targeted drugs that help regulate those genes. Other
molecules target the proteins that are encoded by the cancer causing
genes. Early detection technologies that use novel imaging methods to
find the cancer causing genes and proteins in tumors are enabling
clinicians to devise tailored treatment strategies with better odds of
helping patients and with fewer side effects.
Discoveries within laboratories will aid in preventing, detecting,
and controlling the disease of cancer, empowering cancer patients with
a better quality lifestyle and a more productive, longer life. Some
will be cured. Others, through novel means of early detection or
powerful new therapeutics, will circumvent the arduous plight of
cancer.
Opportunities in cancer research have never been so abundant. New
challenges await us. Those challenges stem in part from the changing
demographics within the United States and across the world. We are an
aging population in the United States. As we age, our risk of cancer
increases. Only 2.2 people in every 100,000 Americans under the age of
65 develop cancer. Once past that landmark age, 10 times that number of
people develop cancer.
In the next 15 years, one-fifth of the American people will become
65 years or older. Already, 12 percent of the American population is 66
years or older. The risk of getting cancer is compounded by the large
number of people entering this higher risk category. The number of
people who develop cancer is expected to grow exponentially. As a
society, we have the opportunity to avert this pending crisis.
Two recent actions have started us in the right direction to avoid
a cancer crisis of epidemic proportions. The first was the recent
completion of the 5-year doubling of the NIH budget. The second was the
bold Challenge Goal pronounced in 2001 by the Director of the National
Cancer Institute: To eliminate the suffering and death from cancer by
2015. The American Association for Cancer Research supports the
Director's challenge goal and stands ready to assist and contribute in
any way possible to meet this challenge.
The state of scientific knowledge and technology has never been
greater. Continued strong investment now will allow us to accelerate
the pace of discovery and optimize the use of existing and new
knowledge for the development and delivery of effective new cancer
treatments.
Many of these opportunities are cogently set forth in A Plan and
Budget Proposal for Fiscal Year 2005 prepared by the Director of the
National Cancer Institute. Informally referred to as the ``Bypass
Budget,'' this document is mandated by Congress as part of the National
Cancer Act of 1971. Its purpose is to set forth the National Cancer
Institute's forward-looking strategic plan to build on its research
successes, support the cancer research workforce with the technologies
and resources it needs, and ensure that research discoveries are
applied to improve human health. The Bypass Budget is provided directly
to the President for formulating the budget request to Congress. It is
developed in close consultation with all sectors of the cancer
community, including scientists and cancer survivors, and represents
the NCI Director's best professional judgment on the opportunities
available and the resources needed to optimize progress in the fight
against cancer in that fiscal year.
The American Association for Cancer Research strongly supports the
concept of the Bypass Budget. It is a vital tool to generate further
research advances. AACR has identified a series of priority areas for
investment--within the scope of the National Cancer Institute's action
plan--that will significantly contribute to the achievement of the
Director's Challenge Goal.
In core scientific areas, AACR has identified the following
priorities:
--Enhancing Investigator-initiated Research.--Individual
investigators in their laboratories and clinics are the
foundation stone for innovations and advances in biomedical
science. Their discoveries lead to better science and its
productive application to patient care. Yet fewer than one-
quarter of peer reviewed and approved research grant requests
from these scientists are funded by the NCI. Increased funding
for competing research grants and resources for investigator-
initiated research are vital to the success of the cancer
research enterprise.
--Molecular Targets of Prevention, Diagnosis, and Treatment.--Some of
the most promising recent advances in cancer research have come
from our increased understanding of the molecular causes of
cancer. Intensified research will increase the number of
effective cancer interventions directed at validated targets.
--Development of Cancer Imaging and Molecular Sensing Technologies.--
Imaging advances are increasingly important in cancer treatment
and care to non-invasively assess cancer progression.
In the area of public health, AACR includes the following among its
priorities:
--Research on Tobacco and Tobacco-related Cancers.--Tobacco use is
the leading preventable cause of death in the United States and
is linked to nearly one-third of all deaths from cancer.
Significant research investments are essential to accelerate
research to understand, prevent, and treat tobacco use and
addiction and to develop effective public health strategies to
combat it.
--Research on Obesity, Physical Activity, Diet, and Nutrition.--
Obesity may soon exceed tobacco as the primary cause of cancer.
Extensive further research is critical to develop effective
preventive strategies and interventions to protect the majority
of our population that is at risk.
--Reducing Cancer-related Health Disparities.--The burden of cancer
falls unequally on our society, with the low-income, medically
underserved, elderly, and minority populations affected
disproportionately by the disease. Further research is urgently
needed to discover the causes for these disparities and to
develop and deliver effective interventions to eliminate them.
In addition to the recommendations above, AACR has identified five
other priority areas that are of key importance to accelerating
progress against cancer:
--Cancer Prevention.--Cancer prevention and behavioral modification
must be fundamental components of any realistic attempt to meet
the Director's 2015 Challenge Goal. Concentrated and
accelerated research is essential to generate new knowledge and
advances in this largely uncharted territory.
--Aging and Cancer.--Close to 60 percent of all new cancers are in
persons older than 65. Further research is urgently needed to
adequately prepare for the impact of our aging population on
our nation's healthcare system.
--Training Translational Researchers.--The number of physician-
scientists who take findings from the laboratory through the
preclinical, clinical, and regulatory processes to the
patient's bedside are dwindling. This kind of translational
cancer research demands a high level of research skill. Managed
care allows very little time for physicians to engage in such
research, and there is minimal funding and no defined career
path for translational and clinical cancer researchers.
Increased federal funding for training is crucial to attract,
educate, train, and retain these clinical personnel if we are
to have the skilled workforce needed to defeat cancer in the
near future.
--Expanding Our National Clinical Trials Program.--Patients in
clinical trials receive the most advanced treatment and
prevention approaches for their particular cancers. These
trials are highly cost effective; however, fewer than 5 percent
of adult cancer patients participate in clinical trials, as
compared to nearly 80 percent of children with cancer.
Augmented funding for the national clinical trials program is
necessary so that adult participation, especially by minority
and underserved patients, is doubled to at least 10 percent.
--Extending the Bioinformatics Infrastructure.--The value of the vast
expansion of biomedical knowledge generated by today's
researchers will match its potential value and usefulness only
when it is collected, organized, integrated, stored, and made
readily and universally accessible to the entire research
community. Funding is needed to develop the state-of-the-art
bioinformatics infrastructure for data mining and integration
that is vital to accelerate research progress.
To maintain this nation's leadership in advanced biomedical
research, and to take advantage of the abundant opportunities for
research progress, we ask that you provide the National Institutes of
Health with a sufficient level of funding to sustain the research
momentum generated by the completion of the 5-year doubling of the
budget. NIH officials and outside experts have testified that annual
increases of at least 10 percent are required to preserve the research
energy that has been unleashed by the doubling.
The cancer community is grateful for the 3.1 percent increase in
the budget that the NIH received in 2004, but is deeply concerned about
its impact on future progress. This is particularly troubling in light
of the President's fiscal year 2005 Budget Request that only seeks a
2.6 percent increase for the NIH for next year. AACR shares this
concern and urges the Committee to move boldly to furnish the funding
levels necessary to undertake promising new research initiatives and to
extend ongoing cutting-edge research through 2005 and beyond.
Specifically we urge your support to increase the budget of the
National Institutes of Health to at least $30.61 billion in 2005. This
10 percent increase will allow the NIH to sustain and build upon its
research progress while avoiding the severe disruption caused by cuts
or nearly flat funding that is less than the rate of inflation.
We also ask that you fully fund the fiscal year 2005 Bypass Budget
of the National Cancer Institute. At that level of funding, the NCI
will be able to realize many of the vitally important research priority
areas identified above and make the boldest strides possible against
this disease. Thus, the AACR requests that the Committee fund the
fiscal year 2005 NCI Bypass Budget request of the Director in the
amount of $6.2 billion.
We have made remarkable progress in cancer research since the
passage of the National Cancer Act in 1971. Your unflagging support for
biomedical research for more than three decades has saved millions of
lives and nurtured the productive research careers of thousands of our
brightest and most dedicated scientists. More than 9.6 million cancer
survivors alive today attest to the successful achievement of many of
the goals of the National Cancer Act. With your continued positive
support and leadership, the cancer community will be able to capitalize
on the research momentum to convert our discoveries and new knowledge
into the strategies and therapies that will make the Director's 2015
Challenge Goal a reality for all Americans.
______
Prepared Statement of the Lymphoma Research Foundation
I am Melanie Smith, Director of Public Policy and Advocacy for the
Lymphoma Research Foundation (LRF). I would like to express our
appreciation for the opportunity to submit this statement to the record
of the Labor, Health and Human Services and Education Appropriations
Subcommittee. The LRF is the nation's largest lymphoma voluntary health
organization, devoted to funding lymphoma research and providing
information about the diseases to individuals diagnosed with lymphoma
and their families and friends.
Our ultimate goal is to find a cure for all forms of lymphoma. To
that end, we fund some of the world's leading lymphoma researchers at
outstanding academic institutions. These researchers are engaged in
research aimed at understanding the basic mechanisms of lymphoma and
improving the current treatments for the disease. LRF also aims to
equip those who are diagnosed with lymphoma with up-to-date information
about treatment options. The organization sponsors educational
conferences at which the leaders in lymphoma research and treatment
address patients and families regarding cutting-edge research and the
most recent developments in therapies.
BACKGROUND ON LYMPHOMA
Lymphoma is a major health problem. This year, approximately 54,400
cases of non-Hodgkin's lymphoma (NHL) will be diagnosed in this
country, and more than 19,400 Americans will die from NHL. Also this
year, 7,880 cases of Hodgkin's lymphoma will be diagnosed, and more
than 1,320 Americans will die from the disease. Lymphoma is the most
common form of blood cancer and the third most common form of childhood
cancer. Nearly 500,000 Americans are living with lymphoma.
In recent years, there have been exciting reports regarding the
improvements in treatments for a number of forms of cancer, as well as
reports that the incidence of cancer overall is declining. Regrettably,
NHL stands in contrast to the general trends in cancer incidence, and
the treatment options for NHL remain inadequate. Since the early 1970s,
incidence rates for NHL have nearly doubled, although incidence rates
have stabilized the last few years. And the 5-year survival rate for
NHL stands at 57 percent. These are not satisfactory numbers, and they
serve as measures of the work we still have to do.
RESEARCH ON LYMPHOMA
In recent years, we have learned a great deal about the genetic,
molecular, and cellular basis of cancer. We do not know the cause of
most lymphomas, but there is increasing information to suggest a link
between environmental factors and infections and the development of
many lymphomas. The environmental factors include chemicals, toxins,
and ultraviolet light, and the infectious agents include simian virus-
40, hepatitis C, and Epstein Barr virus. There is also evidence that in
some individuals, immune dysfunction is a critical factor in the
development of lymphoma.
Our knowledge of cancer has improved significantly in the last
decade, in large part due to the strong commitment of Congress to the
National Institutes of Health (NIH) and its willingness to boost NIH
funding, year after year. These funds have supported strong basic and
clinical researchers who are focused on unlocking the secrets to
cancer. There is a need to sustain that commitment to NIH, in order to
equip scientists engaged in basic research and facilitate the
translation of basic research findings into new treatments. This is
certainly true in the case of lymphoma. There is a need to clarify the
interactions among the environmental, viral, and immunogenetic factors
that contribute to development of lymphoma and to ensure the
development of new treatments based on our enhanced understanding of
lymphoma.
Over the last decade, several new lymphoma treatments have been
developed, expanding the options for those who are diagnosed with the
disease. Lymphoma patients and researchers have clearly benefited from
the nation's significant investment in research, and Congress deserves
the appreciation of the community of lymphoma patients and researchers.
Among the lymphoma treatments approved in the last decade are a
monoclonal antibody and two different radioimmunotherapies. While we
applaud the new treatments of the last decade, they are not a magic
bullet; for many, lymphoma continues to be a fatal disease.
New therapies that capitalize on different research approaches are
currently under investigation. These include therapeutic vaccines,
immunotherapies, and proteasome inhibitors. Other work is focused on
refining the chemotherapy regimens and developing treatment regimens
with lower toxicities. All of this work deserves the support of private
and public research funders.
ROLE OF NIH IN LYMPHOMA RESEARCH
Although LRF plays a critical and creative role in funding lymphoma
research, NIH is, and will remain, the key player in this field. NIH is
the pivotal player not only because of the magnitude of its financial
commitment to lymphoma research, but also because of the role it can
play in bringing together all of the partners in the research
community--NIH intramural researchers, academic researchers, private
foundations, industry, and the Food and Drug Administration (FDA).
NIH is also in the best position to encourage, facilitate, and fund
the translation of basic research findings into new treatments. It is
absolutely critical that we not lose the research momentum that has
been the result in significant part of the doubling of the NIH budget
between 1999 and 2003. This will require much more attention to
translational and clinical research.
LRF recommends that NIH strengthen its lymphoma research program by
several actions:
--The National Cancer Institute (NCI) should boost its support for
translational and clinical lymphoma research. NCI should
evaluate its current investment in clinical research and expand
or initiate programs to strengthen the clinical research
effort.
--NCI should also enhance its support for correlative studies of
tumor biology and treatment response, as well as its investment
in research on the late and long-term effects of current
lymphoma treatments.
--The rate of payment for enrolling patients in NCI-sponsored
clinical trials must be increased, as the current rate is
inadequate to meet the costs associated with enrolling a
patient in a clinical trial and collecting and analyzing the
data associated with trial participation.
--NCI should enhance its research effort focused on understanding the
complex interaction among environmental, viral and
immunogenetic factors that are involved in the initiation and
promotion of lymphoma.
--Although NCI has historically been the lead institute in funding
lymphoma research, other institutes--the National Heart, Lung
and Blood Institute (NHLBI), the National Institute on Aging
(NIA), and the National Institute of Environmental Health
Sciences (NIEHS)--should also evaluate and improve their
lymphoma research programs. NIEHS has recently launched a
targeted program to investigate the environmental links to
breast cancer, and a lymphoma-focused program would be a
logical outgrowth of the breast cancer program.
A strong partnership among voluntary health agencies like LRF,
academic researchers, industry, NIH, and FDA will be optimal for
advancing lymphoma research and improving the outlook for those who are
diagnosed with the disease. New strategies are necessary for the rapid
translation of basic research findings into new treatments. These
strategies may include systems for funding collaborative research
projects that engage researchers in multiple institutions and multiple
disciplines, including academic researchers and industry. Private
foundations are looking at creative means to ensure that their research
dollars are optimized, and we encourage NIH to employ the same creative
and flexible approaches.
ROLE OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION IN BLOOD CANCER
EDUCATION
LRF is actively engaged in providing patients and their families
and caregivers complete and up-to-date information about lymphoma,
lymphoma research, and lymphoma treatment options. Because of our
strong history in this area, we were gratified when Congress authorized
and funded a program at the Centers for Disease Control and Prevention
(CDC) for public and patient education on blood cancers. According to
the authorizing statute and appropriations report language, the
appropriated funds are intended to support private sector organizations
that are engaged in blood cancer education. We believe these funds can
be used effectively by organizations that have extensive experience in
these educational efforts, and we encourage Congress to fund the
program in fiscal year 2005, for a second year, to ensure that there is
no sudden discontinuation of a worthy educational initiative.
LRF believes that strong partnerships will be a key feature of
efforts to improve lymphoma treatments and provide lymphoma patients
current information about their disease and treatment options. We
encourage NCI to fund collaborative research ventures, and we urge CDC
to support those private organizations that have years of experience in
patient education. Those who receive a diagnosis of lymphoma face
difficult choices, and we must work together to improve their options.
______
Prepared Statement of WomenHeart, the National Coalition for Women With
Heart Disease
Heart disease is the leading cause of death for American women,
killing nearly 500,000 each year. Yet, according to a recent American
Heart Association poll, less than half (46 percent) of women know this
basic fact and, even more troubling, only 13 percent think that heart
disease is their own most important health risk.
Ignorance often has fatal consequence. Women are not educated about
their risk factors for heart disease so often do not take the necessary
steps, such as cholesterol and blood pressure checks, to prevent or
intervene in the earliest stages of the disease. They also are unaware
of the signs and symptoms of heart attacks in women, which may differ
than those in men. As a result, they do not get to the emergency room
quickly enough to receive life-saving treatment. Many often die at
home.
We ask the Subcommittee to increase funding for public education
programs to increase women's knowledge of their heart disease risks and
symptoms. Specifically, we urge a $10 million appropriation for NIH's
National Heart, Lung and Blood Institute's existing ``Heart Truth''
campaign, which has been only modestly funded to-date. Through its
adoption of the Red Dress as the national symbol for women and heart
disease awareness, and the First Lady's participation in its public
event, the campaign has put this long-ignored crucial women's health
issue on the national agenda and is reaching thousands of women through
its media relations and community outreach initiatives. However, a more
significant campaign is needed to reach the millions of American women
who are at-risk for or undiagnosed with heart disease.
Thank you for your consideration.
The National Coalition for Women with Heart Disease is the nation's
only patient advocacy organization representing the 8,000,000 that aims
to increase their quality of life and quality of healthcare through
support, information and advocacy. It is a non-profit public charity
headquartered in Washington, DC.
______
Prepared Statement of the Upper County Branch, Montgomery County,
Maryland Stroke Club
A STROKE SURVIVOR: A PERSONAL STORY
Hello. My name is Susan Emery. I am the presiding officer of the
Upper County Branch of the Montgomery County Stroke Club and I'm a
stroke survivor.
Our club conducts education and support activities for stroke
survivors, their family members, and caregivers. We serve people in the
Maryland suburbs of Washington, D.C., and are fortunate to be in the
same county as the National Institutes of Health. We have benefited on
many occasions by the participation of NIH staff members in our
membership meetings. They have been generous in sharing information
about their research into stroke prevention and treatment with us.
On December 26, 1965 at the age of 9, I was playing a new game with
my brother and a few friends at the kitchen table. That's the last
thing that I remember. I was unconscious for the next 2 days. My mother
first learned, incorrectly, that I had spinal meningitis. I was
transferred to another hospital where my mother was told that I had
little chance of survival. Yet I'm here, more than 37 years later, and
I've survived a stroke.
People seldom associate strokes with children. These strokes are
rare, but they do happen. There are about three cases of stroke per
year in every 100,000 children under age 14. One of the difficulties in
dealing with strokes in children is getting the right diagnosis
quickly. There are often delays in diagnosis of childhood stroke.
I spent 2 weeks in the hospital and the following 4 months in
intensive physical therapy. My tenth birthday was spent in the
hospital, and I have a picture in my photo album of myself with my
mother and a new friend. My right eye is turned down, my mouth is
turned down, but I'm still smiling. During the 4 months in therapy at
Holy Cross in Detroit, I learned the basics: how to walk, how to talk,
and how to move the fingers on my right hand. My mother followed the
doctor's instructions and sent me back to school very quickly, where
classmates helped me button and unbutton my coat and carry my books,
and teachers taped papers to the desk so I could learn to write again.
I survived that 4 months, and would never wish to repeat it.
I've been in therapy six times in my life. I need to tell you about
the one time that was the most important to my family. I was 26 years
old and had just had my first child. I kept her safe, for I knew my
limitations. I always used my left hand to support her. But when she
was 6 months old, she got to be a little heavy, and twice, as I was
putting her on the floor to change her diaper, my right hand slipped
from under her buttocks. She fell only inches in both cases and didn't
even notice. But I noticed. I went in for 2 or 3 months of therapy
close to Denver, Colorado, where I was living at the time. Here for the
first time, they helped my right hand and arm dexterity through
occupational therapy. I also learned that I had aphasia--the inability
to speak, write or understand spoken or written language because of
brain injury--because I called things like cornucopias, unicorns
instead of fruit baskets. Instead of the word being the same, I picked
a word that sounded the same. These therapists in Colorado worked with
my mind and my body and I will forever be in their debt.
Close to 15 years ago, I made a new life for myself in Maryland.
Here, I've been an outpatient at the National Rehabilitation Hospital
three times: once for my right foot, once for my Achilles tendon and
once for my right knee. I've seen numerous physiatrists, all of whom
are excellent in their field. I've also seen my fair share of
therapists. Since I've had therapy off and on for most of my life, I
can honestly say that the first few times you go in to see a therapist,
you'll come out hurting more than when you went in. But in the long
run, they help tremendously.
On a work related note, I received a Bachelor of Science in 1978
from Michigan State University in Computer Science and worked for 12
years in the field. I started working in the telecommunications
industry in 1990, and got a Master of Science from the University of
Maryland, University College in Telecommunications Management. I now
work for ITT Industries as a senior engineer on a contract supporting
the Federal Aviation Administration's leased telecommunications
activities, and have worked there for more than 6 years. I've done more
than survive. I've become a productive member of society.
Stroke research has changed my life. Without the research carried
out 40 to 50 years ago, I would not have benefited from electric shock
therapy that made me understand the muscles that moved my fingers.
Without research done 30 years ago, I may not have been able to
understand how to exercise my hand for dexterity. Without research
performed 10 years ago, the people around me would not understand that
they need to get me to the hospital quickly if ever I have another
stroke. Without current support, researchers may never understand how
to stop strokes before they happen or how to make current stroke
survivors live healthier lives.
Stroke remains America's No. 3 killer and a major cause of
permanent disability. An estimated 4.8 million Americans live with the
consequences of stroke and about 1 in 4 is permanently disabled. Yet,
stroke research receives a mere 1 percent of the National Institutes of
Health budget. I strongly urge you to significantly increase funding
for the National Institutes of Health-supported stroke research,
particularly for National Institute of Neurological Disorders and
Stroke-supported stroke research. NIH stroke research is essential to
prevent strokes from happening to children and adults in the first
place, and to advance recovery and rehabilitation of those who survive
this potentially devastating illness.
______
Prepared Statement of the Illinois Neurofibromatosis, Inc.
Thank you for the opportunity to present testimony to the
Subcommittee on the importance of continued funding for
Neurofibromatosis (NF), a terrible genetic disorder closely linked to
cancer, learning disabilities, heart disease, brain tumors, and other
disorders affecting up to 150 million Americans in this generation
alone. Thanks in large measure to this Subcommittee's support;
scientists have made enormous progress since the discovery of the NF1
gene in 1990. Major advances in just the past year have ushered in an
exciting era of clinical and translational research in NF with broad
implications for the general population.
I am David Evans, representing Illinois Neurofibromatosis, Inc.,
which is a participant in a national coalition of NF advocacy groups. I
have lived with NF my entire life. Although I have not suffered any of
NF's severe symptoms; I have experienced the social problems caused by
being afflicted with NF. I have endured rude comments and harassment my
entire life. On July 4, 1996 I was threatened with arrest if I would
not leave a water park in Crestwood, Illinois. After other patrons
complained to the owner, he informed me that I looked ``terrible'' and
should wear a shirt or leave. I explained NF to him and assumed the
matter was settled. Later however, he brought in the police and I was
forced to leave. As a result of this experience I became active in
Illinois NF, Inc. and have been on the board of directors since 1997.
WHAT IS NF?
NF is a genetic disorder involving the uncontrolled growth of
tumors along the nervous system which can result in terrible
disfigurement, deformity, deafness, blindness, brain tumors, cancer,
and/or death. NF can also cause other abnormalities such as unsightly
benign tumors across the entire body and bone deformities. In addition,
approximately one-half of children with NF suffer from learning
disabilities. It is the most common neurological disorder caused by a
single gene. While not all NF patients suffer from the most severe
symptoms, all NF patients and their families live their lives with the
uncertainty of not knowing whether they will be seriously affected one
day because NF is a highly variable and progressive disease.
Approximately 100,000 Americans have NF, and it appears in
approximately 1 in every 3,500 births. It strikes worldwide, without
regard to gender, race or ethnicity. Approximately 50 percent of new NF
cases result from a spontaneous mutation in an individual's genes, and
50 percent are inherited. There are two types of NF: NF1, which is more
common, and NF2, which primarily involves acoustic neuromas and other
tumors, causing deafness and balance problems. Advances in NF research
will benefit over 150 million Americans in this generation alone
because NF is directly linked to many of the most common diseases
affecting the general population.
LINK TO OTHER ILLNESSES
Researchers have determined that NF is closely linked to cancer,
heart disease, learning disabilities, memory loss, brain tumors, and
other disorders including deafness, blindness and orthopedic disorders.
Research on NF therefore stands to benefit millions of Americans:
Cancer.--Research has demonstrated that NF's tumor suppressor
protein, neurofibromin, inhibits RAS, one of the major malignancy
causing growth proteins involved in 30 percent of all cancer.
Accordingly, advances in NF research may well lead to treatments and
cures not only for NF patients but for all those who suffer from cancer
and tumor-related disorders. Similar studies have also linked epidermal
growth factor receptor (EGF-R) to malignant peripheral nerve sheath
tumors (MPNSTs), a form of cancer which disproportionately strikes NF
patients.
Heart disease.--Researchers have demonstrated that mice completely
lacking in NF1 have congenital heart disease that involves the
endocardial cushions which form in the valves of the heart. This is
because the same ras involved in cancer also causes heart valves to
close. Neurofibromin, the protein produced by a normal NF1 gene,
suppresses ras, thus opening up the heart valve. Promising new research
has also connected NF1 to cells lining the blood vessels of the heart,
with implications for other vascular disorders including hypertension,
which affects 45 million Americans. Researchers believe that further
understanding how an NF1 deficiency leads to heart disease may help to
unravel molecular pathways affected in genetic and environmental causes
of heart disease.
Learning disabilities.--Learning disabilities are the most common
neurological complication in children with NF1. Research aimed at
rescuing learning deficits in children with NF could open the door to
treatments affecting 35 million Americans and 5 percent of the world's
population. Indeed, leading researchers have already rescued learning
deficits in both mice and fruit flies with NF1, which will benefit all
people with learning disabilities, not just those with NF as well as
save federal, state and local governments and school districts billions
of dollars in special education costs.
Deafness.--NF2 accounts for approximately 5 percent of genetic
forms of deafness. It is also related to other types of tumors,
including schwannomas and meningiomas, as well as being a major cause
of balance problems.
SCIENTIFIC ADVANCES
The progress that has been made in NF research has been nothing
short of phenomenal. In just over a dozen years since the discovery of
the NF1 gene, researchers are now on the threshold of developing a
treatment and cure for this terrible disease. Scientists who previously
had been pessimistic are now genuinely excited about engaging in
therapeutic experimentation and the phase II clinical trials already
being conducted by NIH. Because of NF's implication with so many other
diseases, many NF researchers believe that NF should serve as a model
to study all diseases. Indeed, one leading researcher has stated that
more is known about NF genetically than any other disease.
In just the past few years, scientists have made major
breakthroughs bringing NF fully into the translational era, with
treatments close at hand. These recent advances have included:
--Phase II clinical trials on two drug therapies;
--Developing advanced mouse models showing human symptoms;
--Rescuing learning deficits in mice;
--Linking NF to hypertension, which affects 45 million Americans, as
well as congenital heart disease; and
--Launching natural history studies to analyze the progression of the
disease.
Other advances since 1990 include:
--The discovery of the NF1 and NF2 genes and gene products.--The NF1
gene was discovered in 1990 and the NF2 gene was discovered in
1993.
--Determination and understanding of the functions of the NF1 and NF2
genes and gene products, including the discovery of new
pathways impacted by the NF genes and gene products. Most
strikingly, researchers have discovered that NF regulates both
the c-AMP pathway affecting learning and memory as well as the
ras pathway affecting cancer. This discovery, which brought
together cancer and neurology through NF's controlling both of
these related pathways, holds monumental implications for
finding the treatments and cures for many diseases which affect
a vast segment of the population.
--Development of advanced animal models.--Researchers have developed
advanced mouse models which exhibit human symptoms, such as
malignant tumors, leukemia, and learning disabilities. Such
animal models provide a unique method for addressing the
fundamental aspects of disease development and for testing
therapeutic strategies. NF researchers have also developed the
fruit fly as a model animal organism to study not only NF but
many other diseases.
--Commencement of clinical trials at NCI.--As a result of the
enormous progress made in NF research, NCI has already
commenced two clinical trials with pediatric NF1 patients,
including phase II trials using of farnesyl transferase
inhibitors and phase I trials using pirfenidone, and is
developing a third clinical trial.
--Development of drug and gene therapies.--Leading NF researchers
have been actively engaged in developing both drug and gene
therapeutic experimentation in mice and fruit flies. In the
case of NF1, these experiments have been directly related to
tumor suppression and learning deficits. Researchers also
believe that a gene therapy for NF2 can be developed; unlike
other genetic forms of deafness, in which a mutation leads to a
development or structural abnormality in the ear for which it
would be difficult to envisage a treatment in the adult, NF2-
associated deafness is potentially preventable or curable if
tumor growth is halted before damage has been done to the
adjacent nerve.
--Rescuing learning deficits in animal models.--A paper published in
the January 30, 2002 edition of Nature demonstrated how
researchers were able to rescue learning deficits in mice with
the same mutation that causes NF1 in humans--disabilities once
thought to be irreversible. This discovery has enormous
implications for the 35 million Americans suffering from
learning disabilities. Studies on fruit flies have also
demonstrated that the neurofibromin protein regulates the c-AMP
pathway which is known to control learning and memory.
--Development of Infrastructure.--Researchers, with the help of the
government, have been building expanded national and
international NF centers, consortia, and other infrastructure
for clinical and translational research and treatment.
FUTURE DIRECTIONS
NF research has now advanced to the translational and clinical
stages which hold incredible promise for NF patients, as well as for
patients who suffer from many of the diseases linked to NF. This
research is costly and will require an increased commitment on the
federal level. Specifically, future investment in the following areas
would continue to advance research on NF:
--Clinical trials;
--Development of a clinical trials network to connect patients with
experimental therapies;
--Development of new drug and genetic therapies;
--Further development of advanced animal models;
--Expansion of biochemical research on the functions of the NF gene
and discovery of new targets for drug therapy;
--Natural history studies and identification of modifier genes--
studies are already underway to provide a baseline for testing
potential therapies and differentiate among different
phenotypes of NF; and
--Development of NF Centers, tissue banks, and patient registries.
CONGRESSIONAL SUPPORT FOR NF RESEARCH
The enormous promise of NF research--and its potential to benefit
tens of millions of Americans in this generation alone--has gained
increased recognition from Congress and the NIH. This is evidenced by
the fact that seven Institutes at NIH are currently supporting NF
research (NINDS, NCI, NICHD, NCRR, NEI, NIDCD, and NHLBI), and NIH's
total research portfolio has increased from $3 million in 1990 to over
$20 million in fiscal year 2004.
The enormous advances in NF research would not have been possible
without Congress's continued support of the NIH, and I would like to
personally thank the members of this Subcommittee for their leadership
in doubling the budget of the NIH over 5 years.
At the same time, we are concerned that the NF research portfolio
at both the National Cancer Institute and the National Institute of
Neurological Disorders and Strokes has declined by several million
dollars in recent years, despite appropriations report language
recommending a greater investment. Given the potential offered by NF
research for progress against a range of diseases, and the completion
of the 5-year doubling of the NIH budget, we are hopeful that NCI and
NINDS will substantially increase NF research funding. We appreciate
the Subcommittee's strong support for NF research dating back to 1990,
and will continue to work with you to ensure that opportunities for
major advances in NF research are aggressively pursued.
This Subcommittee has long recognized that our goal should be to
translate the promise of scientific discovery into an improved quality
of life for all Americans. The example of the progress realized in NF
research demonstrates the success of this vision and commitment.
Thank you again for the opportunity to tell you of the progress and
potential of NF research.
______
Prepared Statement of the American Association for Geriatric Psychiatry
The American Association for Geriatric Psychiatry (AAGP)
appreciates this opportunity to present its recommendations on issues
related to fiscal year 2005 appropriations for mental health research
and services. AAGP is a professional membership organization dedicated
to promoting the mental health and well being of older Americans and
improving the care of those with late-life mental disorders. AAGP's
membership consists of approximately 2,000 geriatric psychiatrists as
well as other health professionals who focus on the mental health
problems faced by senior citizens.
AAGP would like to thank the Subcommittee for its continued strong
support for increased funding for the National Institutes of Health
(NIH) over the last several years, particularly the additional funding
you have provided for the National Institute of Mental Health (NIMH),
the National Institute on Aging (NIA), the National Institute on
Alcohol Abuse and Alcoholism (NIAAA), and the Center for Mental Health
Services (CMHS) within the Substance Abuse and Mental Health Services
Administration (SAMHSA). Although we generally agree with others in the
mental health community about the importance of sustained and adequate
Federal funding for mental health research and treatment, AAGP brings a
unique perspective to these issues because of the elderly patient
population served by our members.
There are serious concerns, shared by AAGP and researchers,
clinicians, and consumers that there exists a critical disparity
between appropriations for research, training, and health services and
the projected mental health needs of older Americans. This disparity is
evident in the convergence of several key factors:
--demographic projections inform us that, with the aging of the U.S.
population, there will be an unprecedented increase in the
burden of mental illness among aging persons, especially among
the baby boom generation;
--this growth in the proportion of older adults and the prevalence of
mental illness is expected to have a major direct and indirect
impact on general health service use and costs;
--despite the fact that effective treatment exists, the current
mental health needs of many older adults remain unmet;
--the number of physicians being trained in geriatric mental health
research and clinical care is insufficient to meet current
needs, and this workforce shortfall is projected to become a
crisis as the U.S. population ages over the next decade;
--a major gap exists between research, mental health care policy, and
service delivery; and
--despite recent significant increases in appropriations for support
of research in mental health, the allocation of NIMH and CMHS
funds for research that focuses specifically on aging and
mental health is disproportionately low, and woefully
inadequate to deal with the impending crisis of mental health
in older Americans.
DEMOGRAPHIC PROJECTIONS AND THE MENTAL DISORDERS OF AGING
With the baby boom generation nearing retirement, the number of
older Americans with mental disorders is certain to increase in the
future. By the year 2010, there will be approximately 40 million people
in the United States over the age of 65. Over 20 percent of those
people will experience mental health problems. A national crisis in
geriatric mental health care is emerging and has received recent
attention in the medical literature. Action must be taken now to avert
serious problems in the near future. While many different types of
mental and behavioral disorders can occur late in life, they are not an
inevitable part of the aging process, and continued research holds the
promise of improving the mental health and quality of life for older
Americans.
The current number of health care practitioners, including
physicians, who have training in geriatrics is inadequate. As the
population ages, the number of older Americans experiencing mental
problems will almost certainly increase. Since geriatric specialists
are already in short supply, these demographic trends portend an
intensifying shortage in the future. There must be a substantial public
and private sector investment in geriatric education and training, with
attention given to the importance of geriatric mental health needs. We
will never have, nor will we need, a geriatric specialist for every
older adult. However, without mainstreaming geriatrics into every
aspect of medical school education and residency training, broad-based
competence in geriatrics will never be achieved. There must be adequate
funding to provide incentives to increase the number of academic
geriatricians to train health professionals from a variety of
disciplines, including geriatric medicine and geriatric psychiatry.
Current and projected economic costs of mental disorders alone are
staggering. The direct medical expense to care for a patient with
Alzheimer's disease ranges from $18,000 to $36,000 a year per patient,
depending on the severity of the disease. In addition, there are
substantial indirect costs associated with caring for an Alzheimer's
disease patient including social support, care giving, and often
nursing home care. It is estimated that total costs associated with the
care of patients with Alzheimer's disease is over $100 billion per year
in the United States. Psychiatric symptoms (including depression,
agitation, and psychotic symptoms) affect 30 to 40 percent of people
with Alzheimer's and are associated with increased hospitalization,
nursing home placement, and family burden. These psychiatric symptoms,
associated with Alzheimer's disease, can increase the cost of treating
these patients by more than 20 percent. Although NIA has supported
extensive research on the cause and treatment of Alzheimer's, treatment
of these behavioral and psychiatric symptoms has been neglected and
should be supported through NIMH.
Depression is another example of a common problem among older
persons. Approximately 30 percent of older persons in primary care
settings have significant symptoms of depression; and depression is
associated with greater health care costs, poorer health outcomes, and
increased mortality. Of the approximately 32 million Americans who have
attained age 65, about 5 million suffer from depression, resulting in
increased disability, general health care utilization, and increased
risk of suicide. Older adults have the highest rate of suicide rate
compared to any other age group. Comprising only 13 percent of the U.S.
population, individuals age 65 and older account for 19 percent of all
suicides. The suicide rate for those 85 and older is twice the national
average. More than half of older persons who commit suicide visited
their primary care physician in the prior month--a truly stunning
statistic.
The enormous and widely underestimated costs of late-life mental
disorders justify major new investments. The personal and societal
costs of mental illness and addictive disorders are high, but advances
in research and treatment will help save lives, strengthen families,
and save taxpayer dollars.
THE BENEFITS OF RESEARCH ON PUBLIC HEALTH
The U.S. Surgeon General's Report on Mental Health (1999) and the
Administration on Aging Report on Older Adults and Mental Health (2001)
underscore the prevalence of mental disorders in older persons and
provide evidence that research has lead to the development of effective
treatments. These reports summarize research findings showing that
treatments are effective in relieving symptoms, improving functioning,
and enhancing quality of life. Preliminary findings suggest that these
interventions reduce the need for expensive and intensive acute and
long-term services. However, it is also well demonstrated that there is
a pronounced gap between research findings on the most effective
treatment interventions and implementation by health care providers.
This gap can be as long as 15 to 20 years. These reports stress the
need for translational and health services research focused on
identifying the most cost-effective interventions, as well as creating
effective methods for improving the quality of health care practice in
usual care settings. A major priority (neglected to date) is the
development of a health services research agenda that examines the
effectiveness and costs of proven models of mental health service
delivery for older persons.
Special attention also needs to be paid to inadequately or poorly
studied, serious late-life mental disorders. Illnesses such as
schizophrenia, anxiety disorders, alcohol dependence and personality
disorders have been largely ignored by both the research community and
the funding agencies, despite the fact that these conditions take a
major toll on patients, their care givers, and society at large. Many
of AAGP's members are at the forefront of groundbreaking research on
Alzheimer's disease, depression, and psychosis among the elderly, and
we strongly believe that more research funds must be focused in these
areas. Improving the treatment of late-life mental health problems will
benefit not only the elderly, but also their children, whose lives are
often profoundly affected by their parents' illness.
While the funding increases supported by this Subcommittee in
recent years have been essential first steps to a better future, a
committed and sustained investment in research is necessary to allow
continuous progress on the many research advances made to date.
NATIONAL INSTITUTE OF MENTAL HEALTH
In his fiscal year 2005 budget, the President proposed an increase
of $729 million for the National Institutes of Health (NIH), which
would bring the entire NIH budget to a level of $28.8 billion. However,
this 2.6 percent increase over the fiscal year 2004 funding level pales
in comparison with recent annual double-digit increases. A decline in
adequate funding increases could have a devastating impact on the
ability of NIH to sustain the ongoing, multi-year research grants that
have been initiated in recent years.
For NIMH, the President is proposing $1.421 billion for scientific
and clinical research, a 2.8 percent increase over the agency's fiscal
year 2004 appropriation of $1.382 billion. It is important to note that
from fiscal year 1999 through fiscal year 2004, NIMH received increases
that lagged behind the increases received by many of the other NIH
institutes. Furthermore, the increase proposed by the Administration
for NIMH for fiscal year 2005 is lower than that proposed for most of
the other institutes at NIH. As Congress moves forward with
deliberations on the fiscal year 2005 budget, AAGP believes that NIMH
should receive a percentage increase that, at the very minimum, is
equal to the average percentage increase for the other NIH institutes.
Commendable as recent funding increases for NIH and NIMH have been,
AAGP would like to call the Subcommittee's attention to the fact that
these increases have not always translated into comparable increases in
funding that specifically address problems of older adults. Data
supplied to AAGP by NIMH indicates that while extramural research
grants by NIMH increased 59 percent during the 5-year period from
fiscal year 1995 through fiscal year 2000 (from $485,140,000 in fiscal
year 1995 to $771,765,000 in fiscal year 2000), NIMH grants for aging
research increased at less than half that rate: only 27.2 percent
during the same period (from $46,989,000 to $59,771,000).
AAGP is pleased that NIMH has recently renewed its emphasis on
mental disorders among the elderly, and commends the recent creation of
a new Aging Treatment and Prevention Intervention Research Branch at
NIMH as well as the establishment of an intra-NIMH consortium of
scientists concerned with mental disorders in the aging population.
However, funding for aging mental health research is still not keeping
pace with that of other adult mental health research, and is actually
decreasing proportionally when considered in the context of anticipated
projections in growth of mental disorders in older persons. For
example, the proportion of total NIMH newly funded extramural research
grant funding devoted to aging research declined from an average of 8
percent from fiscal years 1995 to 1999 to a low of 6 percent in fiscal
year 2000. To reverse this trend, it will also be important to
constitute grant review committees with specialized expertise in
geriatrics to ensure a fair review of research proposals. Review
committees must take into account knowledge of the unique biological
factors associated with the aging brain, the high prevalence of co-
occurring medical illnesses, and the specific systems for financing and
health services delivery for older Americans. In addition, AAGP would
like the scope of this branch increased into a comprehensive aging
branch that is responsible for all facets of clinical research,
including translational, interventions, and disease-based
psychopathology. Further, the branch should be given adequate resources
to fulfill its primary mission within NIMH.
In addition to supporting research activities at NIMH, AAGP
supports increased funding for research related to geriatric mental
health at the other institutes of NIH that address issues relevant to
mental health and aging, including the National Institute of Aging
(NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA),
the National Institute on Drug Abuse (NIDA), and the National Institute
of Neurological Disorders and Stroke.
CENTER FOR MENTAL HEALTH SERVICES
It is also critical that there be adequate funding increases for
the mental health initiatives under the jurisdiction of the Center for
Mental Health Services (CMHS) within the Substance Abuse and Mental
Health Services Administration (SAMHSA). While research is of critical
importance to a better future, the patients of today must also receive
appropriate treatment for their mental health problems. SAMHSA provides
funding to State and local mental health departments, which in turn
provide community-based mental health services to Americans of all
ages, without regard to the ability to pay. AAGP was pleased that the
final budgets for fiscal years 2002, 2003 and 2004 included $5 million
for evidence-based mental health outreach and treatment to the elderly.
However, AAGP is extremely alarmed to see that this program was
eliminated in President Bush's fiscal year 2005 budget proposal.
Restoring and increasing this mental health outreach and treatment
program must be a top priority, as it is the only Federally funded
services program dedicated specifically to the mental health care of
older adults.
Originally funded in the Fiscal Year 2002 Labor-HHS-Education
Appropriations (Public Law 107-116), AAGP worked with members of this
Subcommittee and its House counterpart on this initiative, which was
intended as a first step in the effort to curb the projected growth of
older adults in America suffering from mental disorders. The House
Appropriations Committee Report on Fiscal Year 2002 Labor-HHS-Education
Appropriations states that $5 million should be appropriated for a
senior mental health outreach and treatment program within CMHS and
that the funds are ``intended to begin to address'' the predicted
increase of older adults suffering from mental illness. Regarding the
same program, the Senate Appropriations Committee Report states, ``The
Committee strongly encourages CMHS to devote additional resources in
fiscal year 2002 and subsequent fiscal years to this issue.''
Unfortunately, this initiative has not seen the subsequent increases
its creators intended when Congress created this program.
Funding for the dissemination and implementation of evidence-based
practices in ``real world'' care settings must be a top priority for
Congress. Despite significant advances in research on the causes and
treatment of mental disorders in older persons, there is a major gap
between these research advances and clinical practice in usual care
settings. The greatest challenge for the future of mental health care
for older Americans is to bridge this gap between scientific knowledge
and clinical practice in the community, and to translate research into
patient care. Adequate funding for this geriatric mental health
services initiative is essential to disseminate and implement evidence-
based practices in routine clinical settings across the states.
Consequently, we would urge that the $5 million for mental health
outreach and treatment for the elderly included in the CMHS budget for
fiscal year 2004 not only be restored, but also be increased to $20
million for fiscal year 2005.
Of that $20 million appropriation, AAGP believes that $10 million
should be allocated to a National Evidence-Based Practices Program,
which will disseminate and implement evidence-based mental health
practices for older persons in usual care settings in the community.
This program will be a collaborative effort, actively involving family
members, consumers, mental health practitioners, experts, professional
organizations, academics, and mental health administrators. With $10
million dedicated to a program to disseminate and implement evidence-
based practice in geriatric mental health, there will be an assured
focus on facilitating accurate, broad-based sustainable implementation
of proven effective treatments, with an emphasis on practice change and
consumer outcomes. Such a program should include several development
phases including identification of a core set of evidence-based
practices, development of evidence-based implementation, and practice
improvement toolkits and field-testing of evidence-based
implementation. This program will provide the foundation for a longer-
term national effort that will have a direct effect on the well-being
and mental health of older Americans.
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
One of the most valuable resources in our efforts to improve access
to and the quality of geriatric mental health services is the Agency
for Healthcare Research and Quality (AHRQ). In recent years the Agency
has supported important research on mental health topics including
studies on children's mental health issues, the impact of mental health
parity on consumers' share of mental health costs, improving care for
depression in primary care, and cultural issues in the treatment of
mental illness in minority populations. This work has led to important
contributions to the mental health literature, and the advancement of
effective diagnosis and treatment of mental illness. We applaud these
efforts and urge the Committee to increase support for the critical
work of this Agency.
However, we are concerned that the research agenda of the Agency
has not given more attention to geriatric mental health issues. The
prevalence of undiagnosed and untreated mental illness among the
elderly is alarming. Conditions such as depression, anxiety, dementia,
and substance abuse in older adults are often misdiagnosed or not
recognized at all by primary and specialty care physicians. There is
accumulating evidence that depression can exacerbate the effects of
cardiac disease, cancer, strokes, and diabetes. Research has also shown
that treatment of mental illness can improve health outcomes for those
with chronic diseases. Effective treatments for mental illnesses in the
elderly are available, but without access to physicians and other
health professionals with the training to identify and treat these
conditions, far too many seniors fail to receive needed care.
AAGP believes there is an urgent need to translate findings from
aging-related biomedical and behavioral research into geriatric mental
health care. By utilizing the resources of the evidence-based practice
centers under contract to AHRQ, results from geriatric mental health
research can be evaluated and translated into findings that will
improve access, foster appropriate practices, and reduce unnecessary
and wasteful health care expenditures. We urge the Committee to direct
AHRQ to support additional research projects focused on the diagnosis
and treatment of mental illnesses in the geriatric population. We also
believe a high priority should be given to the dissemination of
scientific findings about what works best, to encourage physicians and
other health professionals to adopt ``best practices'' in geriatric
mental health care.
CONCLUSION
Based on AAGP's assessment of the current need and future
challenges of late life mental disorders, we submit the following
fiscal year 2005 funding recommendations:
1. The current rate of funding for aging grants at NIMH and CMHS is
inadequate. Funding for NIMH and CMHS aging-related health services
grants should be increased to be commensurate with current need--at
least three times their current funding levels. In addition, the
substantial projected increase in mental disorders in our aging
population should be reflected in the budget process in terms of dollar
amount of grants and absolute number of new grants;
2. Previous years' funding of $5 million for evidence-based mental
health outreach and treatment for the elderly within CMHS was
eliminated in President Bush's fiscal year 2005 budget proposal. To
help the country's elderly access necessary mental health care, this
funding must be restored and increased to $20 million;
3. A fair grant review process will be enhanced by committees with
specific expertise and dedication to mental health and aging;
4. Adequate infrastructure and funding within both NIMH and CMHS to
support the development of initiatives in aging research, to monitor
the number and quality of applicants for aging research grants, to
promote funding of meritorious projects, and to manage those grant
portfolios;
5. The scope of the recently formed Aging Treatment and Prevention
Intervention Research Branch at NIMH should be increased to include all
relevant clinical research, including translational, interventions, and
disease-based psychopathology, and must receive NIMH's full support so
it may fulfill its primary mission;
6. AHRQ should undertake additional research projects focused on
the diagnosis and treatment of mental illnesses in the geriatric
population, and dissemination of information on best practices; and
7. Funding for NIAAA must be increased by at least 20 percent to
enable it to undertake more research and collect more data focused on
issues such as the link between alcohol use and late-life suicide and
the impact of alcohol use across the lifespan.
AAGP strongly believes that the present research infrastructure,
professional workforce with appropriate geriatric training, health care
financing mechanisms, and mental health delivery systems are grossly
inadequate to meet the challenges posed by the expected increase in the
number of older Americans with mental disorders. Congress must support
funding for research that addresses the diagnosis and treatment of
mental illnesses, as well as programs for delivery of geriatric mental
health services that increase the quality of life for those with late-
life mental illness.
AAGP looks forward to working with the members of this Subcommittee
and others in Congress to establish geriatric mental health research
and services as a priority at NIMH, CMHS, AHRQ and NIAAA.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM), the largest single
life science society with 43,000 members, is pleased to provide
testimony in support of the nation's investment in the extraordinary
work of the National Institutes of Health (NIH). Advances in NIH
research have markedly intensified over the past 5 years during which
the NIH budget has grown thanks to the foresight of Congress and the
Administration. Robust funding increases have resulted in rapid strides
in cutting edge research and new research tools to facilitate the
development of vaccines, therapies and interventions that save and
improve the lives of millions of people.
To ensure that progress is sustained, the ASM recommends that
Congress make research and public health a high national priority and
provide an increase of 10 percent for the NIH for fiscal year 2005.
Continued strong funding increases will enable NIH to accelerate and
expand promising basic and clinical research that will lead to new
preventions and treatments for tragic and costly illnesses and
disabilities that continue to afflict and claim the lives of many
people. The ASM encourages Congress to provide higher funding levels
for research and public health that will address the alarming burden of
disease in the United States and abroad and help prepare the nation for
novel health threats and the next disease emergency that will
inevitably occur in the future.
The public health and security of the nation depend on the
continuation of strong investments in research and public health. The
severe acute respiratory syndrome (SARS) epidemic of 2003 highlights
the continuing need for investment in a strong biomedical and public
health system that is prepared to respond to emerging diseases, whether
naturally occurring or intentionally introduced. Previous NIH
investment in emerging diseases research has allowed expeditious
studies of SARS to identify targets for antiviral drugs, diagnostics
and vaccines. Not only are people at risk for chronic diseases such as
cancer, heart disease, stroke, diabetes and Alzheimer's disease, but
also from new and emerging infectious diseases, such as the HIV
pandemic, highly virulent influenza viruses, West Nile Virus, hepatitis
A and C, and the possibility of the deliberate release of disease by
bioterrorists, which still remains a threat.
The accomplishments and investment in biodefense research,
facilities and resources should also facilitate defenses against
naturally occurring infectious diseases that pose a real and present
danger to global public health. Infectious diseases account for 26
percent of total global mortality and are the third leading cause of
death in the United States. Despite impressive advances in
microbiology, old diseases remain entrenched and new ones can appear
suddenly and spread quickly. Sufficient and sustained federal funding
for research helps protect against these enemies to public health.
INVESTIGATOR INITIATED RESEARCH
Most of the budget appropriated to the NIH each year flows outside
the agency to an estimated 212,000 research personnel affiliated with
approximately 28,000 organizations across the United States and
elsewhere. This extramural research community competes for NIH grants
through a merit based peer-review process; of the growing number of
applications each year, estimated to exceed 35,000, less than one-third
are projected to receive NIH funding. The proposed fiscal year 2005
budget supports an increase in the number of new and competing grants
from 10,135 to 10,393, an additional 258 grants. Investigator initiated
research is the primary tool by which biomedical research is funded and
conducted and requires increased funding to take advantage of
scientific opportunities that lead to new knowledge and its
applications to health care.
NIH ROADMAP FOR MEDICAL RESEARCH
Within the proposed fiscal year 2005 budget, the NIH Roadmap for
Medical Research plan would receive $237 million, an increase of $109
million over fiscal year 2004. Announced in September 2003, this set of
27 initiatives actuates an agency wide commitment to maximize research
investment through intensive, multi-disciplinary projects with high
potential to solve serious health problems. The Roadmap realizes three
21st-century visions of a vigorous research enterprise: building new
pathways to discovery through new technologies, databases, and other
resources; creating multidisciplinary research teams better prepared to
tackle the complexities of modern research; and re-engineering clinical
research structures to expedite the rapid translation of discoveries
from the lab to the clinic. This trans-NIH effort is an approach that
promises to stimulate research advances and interventions for public
benefit.
BIODEFENSE RESEARCH
After the anthrax mail attacks of 2001, biodefense research has
emerged as a major feature of the NIAID's mission to understand the
pathogenesis of disease-causing microorganisms and host responses to
them. NIAID scientists now are pursuing numerous countermeasures as
therapeutics, diagnostics, and vaccines. The agency mobilizes research
capabilities and extramural partnerships to prepare against
``deliberately emerging disease'' outbreaks. The NIH and particularly
the NIAID have become significant partners in the broad-based, multi-
faceted U.S. homeland security program. The fiscal year 2005 budget
highlights the significance of NIAID biodefense efforts, with nearly
$1.7 billion for research and infrastructure, 4.5 percent above fiscal
year 2004's $1.6 billion.
The biodefense agenda at the NIAID reflects a new focus on science
based security. Basic research forms the backbone of the NIAID
counterterrorism efforts and includes microbial physiology and ecology,
genomics, studies of pathogenesis and host defenses, and development of
animal disease models. Strong funding appropriations by Congress and
the Administration over the past 2 years have made possible significant
progress, evidenced by the more than 50 major NIAID biodefense
initiatives now in place. Most of these initiatives are new, with
intramural, academic, and industrial partners investigating all aspects
of bioagents and emerging diseases. Components include expansion of the
nation's biodefense laboratory infrastructure, enhanced communication
and data-collecting networks, interdisciplinary studies on potential
bioweapons, and investigations into basic mechanisms of disease and
disease pathogens.
In 2003 NIAID and its collaborators achieved significant successes
in both basic and applied areas related to biodefense. A candidate
vaccine against the Ebola virus was found to protect lab monkeys
against the deadly disease. Other researchers discovered that the
anthrax bacterium toxin affects host cells in a previously unknown
manner, which will redirect some aspects of anthrax therapeutics.
Genome sequencing projects are on going for at least one strain of
every bacterium, virus or protozoan considered a of priority pathogen.
This vast genomics effort includes mapping of agents for such diseases
as anthrax, brucellosis, Q fever, plague, smallpox, and tuberculosis.
Researchers recently developed a rapid test for measuring antibodies to
vaccinia that is 5 to 10 times more sensitive than standard detection
techniques. NIAID has screened more than 800 compounds for antiviral
activity against poxviruses and two clinical trials of a new smallpox
vaccine have been completed. The search continues for vaccines against
a long list of pathogenic bacteria and viruses, including next
generation vaccines against smallpox and new vaccines for plague,
tularemia, and other viral hemorrhagic fevers.
Current NIAID biodefense programs build upon the NIH tradition of
creating networks of institutions and scientists best qualified to
solve complex problems. Last year the NIAID funded 8 of the 10 planned
Regional Centers for Excellence for Biodefense and Emerging Infectious
Diseases Research (RCEs), at a cost of about $350 million to be
expended over 5 years. The RCEs will be responsible for a broad range
of basic and applied research on disease biology, vaccines, and
antibiotics, as well as development of novel computational and genomic
approaches. As regional centers of excellence, they also will train new
generations of science professionals in biodefense research, provide
facilities for area researchers, and supply facilities and support to
first-line responders in the event of a biodefense emergency. The NIH
also is adding new biodefense-research facilities at its own Bethesda
campus and at other NIH locations. Last fall, NIAID construction grants
were awarded to leading universities for nine high-level biosafety
laboratories. These state-of-the-art labs will contain special
engineering and design features to prevent release into the environment
of the most deadly microorganisms. The facilities also will be
available to assist national, state and local public health officials
when needed. Similar cooperative programs were established by the NIAID
to encourage biodefense research within the pharmaceutical industry,
human immunology research institutes, and computational science
centers. The proposed fiscal year 2005 budget includes continued
support of these efforts, as well as funding for the final two Centers
for Excellence and $150 million for an additional 20 high-level
biosafety laboratories.
INFECTIOUS DISEASE RESEARCH AND PUBLIC HEALTH
Centuries of triumph and defeat mark the human struggle against
infectious disease. Many infectious diseases persist and continue to
plague us. Each year populations are beset by one or more previously
unknown diseases or pathogens. The World Health Organization estimates
that more than 1,600 die each hour from an infectious disease, half
under 5 years of age. Others suffer with debilitating infections. For
instance, an estimated 40 million people worldwide are living with HIV/
AIDS. Tuberculosis, malaria, and other familiar intractable diseases
kill or sicken millions annually. New outbreaks surprise and alarm
nations. Being prepared to detect, treat, and prevent any infectious
disease is the central, science based mission of the NIAID, with well-
funded medical research.
Newly emerging and re-emerging or resurging infectious diseases
constantly change the landscape of microbiological research, creating
moving targets for medical intervention and prevention. West Nile
virus, monkeypox, dengue, multi-drug resistant tuberculosis and malaria
are current examples of what faces NIAID-supported investigators. Last
year's SARS outbreak illustrates the breadth and depth of NIAID
research and response capabilities. It is a cautionary tale of how a
previously unknown disease can quickly become a global news story of
significant economic and public health importance. Within months the
new respiratory illness had caused more than 8,000 cases and nearly 900
deaths in 30 countries, severely disrupting international trade and
travel--and yet it became a triumph for science and public health
efforts, in large part due to effective, well-funded NIAID research.
NIAID-supported scientists in Hong Kong were the first to show that
SARS was caused by a virus; within days, they and CDC investigators
identified the virus as a previously unknown type of coronavirus. An
ongoing NIAID-funded program of influenza surveillance then found
animal carriers of the virus in food markets in China. Related NIAID-
supported work quickly followed, including several genetic analyses of
the virus underway, an NIAID-developed mouse model of SARS, screening
of up to 100,000 antiviral compounds for anti-SARS activity, several
parallel approaches to vaccine development, as well as joint projects
with private industry, researchers abroad, and China's Center for
Disease Control. NIAID funding led to quick development of a rapid
diagnostic test now being improved, and NIAID provides researchers with
free SARS ``gene chips'' embedded with a reference strain of the virus
for genetic screening of isolates. NIAID's extensive and multi-layered
quick response to SARS was possible largely because of previous
investments in virus and respiratory disease research.
Each year NIAID responsibilities for novel diseases grow greater,
not less. Today a new threat of global potential, the so-called bird
flu or H5N1 influenza, is emerging to join diseases like West Nile
virus infection and bovine spongiform encephalopathy (BSE) as targets
of NIAID initiatives. NIH supported laboratories are world leaders in
research on transmissible spongiform encephalopathies that include BSE,
Creutzfeldt-Jakob disease in humans, and chronic wasting disease in
deer and elk. Last year there were more than 9,000 human cases of
mosquito-borne West Nile virus infection in the United States. Since
first detected in 1999, WNV has spread throughout North America and
beyond. NIAID-supported scientists have developed an immunoassay to
identify WNV and a new treatment already in early clinical trials.
A myriad of infectious diseases continue to take a toll on people
worldwide. Infections of the respiratory tract continue to be the
leading cause of acute illness worldwide. In the United States,
diarrhea is the second most common infectious illness and diarrheal
diseases account for 15 to 34 percent of deaths in some countries.
NIAID funding supports a broad variety of basic and applied research to
better understand food- and waterborne-illnesses. Sexually transmitted
infections (STIs) affect over 15 million people in the United States
each year. NIAID-supported researchers recently discovered an unusual
bacterium that may be the cause of many reproductive tract infections
in women. More than 25 STIs have now been identified, and NIAID is
supporting multiple projects aimed at preventing and treating STIs.
Currently a new vaccine for genital herpes is in advanced clinical
trials.
Together, HIV/AIDS, malaria and tuberculosis account for more than
5 million deaths each year. One of the principal goals of 21st-century
medical science is the development of safe and effective vaccines
against these three global killers. In the United States, more than
500,000 have died from AIDS-related illness; the CDC estimates that
850,000 to 950,000 Americans are living with HIV infection. HIV/AIDS
research continues to be a significant component of NIH research: The
Administration's fiscal year 2005 budget requests $2.9 billion for HIV/
AIDS research at NIH, a 2.8 percent increase over fiscal year 2004.
NIAID investigators continue to develop new treatments, and the number
of AIDS vaccines in development and testing increases steadily.
Malaria threatens more than one-third of the world's population and
kills more than 1 million each year. Although United States cases of
malaria are unusual, the NIAID has become a leader in the accelerated
development of malaria vaccines. The agency has initiated its first
trial of a candidate malaria vaccine in Africa. One-third of the
world's population also fights tuberculosis, another major global focus
of the NIAID. A new recombinant vaccine made with several proteins from
the bacterium that cause TB will soon enter human trials. Scientists
recently discovered genetic mutations in the tuberculosis bacterium
that contribute to worrisome antibiotic resistance.
The increasing use of antimicrobials in humans, animals and
agriculture has contributed to pathogen resistance to antibiotics and
some diseases are becoming more difficult to treat because of the
emergence of drug resistance. NIAID supports antimicrobial research and
the goals of the Interagency Task Force for Antimicrobial Resistance.
In recognition of impressive NIAID contributions to public health
and homeland security, the ASM emphasizes that only sustained financial
investment will guarantee continued success against today's infectious
diseases, tomorrow's unpredictable pathogens, and the growing threat of
antimicrobial resistance.
______
Prepared Statement of The Humane Society of the United States
On behalf of The Humane Society of the United States (HSUS) and our
more than 8 million supporters nationwide, we appreciate the
opportunity to provide testimony on our top funding priority for the
Labor, Health and Human Services, and Education Subcommittee in fiscal
year 2005.
PAIN AND DISTRESS RESEARCH
An estimated 40 percent of the National Institutes of Health (NIH)
budget--or currently more than $11 billion--is devoted to some aspect
of animal research. At this time, no funding is set aside specifically
for research into alternatives that replace or reduce the use of
vertebrate animals in research or that reduce the amount of pain and
distress to which research animals are subjected. NIH may receive $28.8
billion in fiscal year 2005 if Congress fulfills the President's budget
request. Out of this funding, we seek $2.5 million (0.009 percent) for
research and development focused on identifying and alleviating animal
pain and distress. We recommend that this R&D be conducted under the
National Center for Research Resources (NCRR, responsible for NIH
extramural funding). We also urge the Committee to specify in report
language that NCRR should conduct this research in conjunction with, or
``piggy-backed'' onto, ongoing research that already causes pain and
distress. No pain and distress should be inflicted solely for the
purpose of this research, given the volume of existing research (we
estimate a minimum of 20-25 percent of all animal research) that is
believed to involve moderate to significant pain and/or distress.
In 1987, NIH announced a program to award grants for ``research
into methods of research that do not use vertebrate animals, use fewer
vertebrate animals, or produce less pain and distress in vertebrate
animals used in research.'' Many of the 17 program awards made from
1987 to 1989, totaling approximately $2.4 million, involved research on
non-mammalian models, including projects on frogs, mollusks, and
insects. Other awards included mathematical modeling and computer
studies. This program, which was managed out of the Division for
Research Resources (the precursor to NCRR), no longer exists at NIH,
and it has not been replaced by any similar program.
A 2001 survey conducted by an independent polling firm indicates
that concern about animal pain and distress strongly influences public
opinion about animal research in general. Public support for animal
research declines dramatically when pain and distress are involved: 62
percent support animal research when pain and distress are minimal,
only 34 percent when moderate, and an even smaller 21 percent when
animal suffering is severe. Despite this public concern, NIH has not
continued to sponsor R&D exploring how to minimize animal suffering and
distress in the laboratory.
During the past several years, our organization has been reviewing
institutional policies and practices with respect to pain and distress
in animal research. We have found that research institutions have
inconsistent policies due to the lack of information on this subject,
and that standards vary greatly from one institution to another.
Painful techniques, such as the use of carbon dioxide to euthanize rats
and mice, are widely practiced and approved even though studies
indicate that carbon dioxide exposure for only a few seconds causes
acute distress to humans. The federal standard for determining
laboratory animal pain specifies that, if a procedure causes pain or
distress to humans, it should be assumed to cause pain and distress to
animals. Furthermore, while human experience can and should provide a
useful guide in some cases, there are others in which humans are never
subjected to the conditions facing laboratory animals. Information on
pain and distress that animals themselves actually experience is
important. For many accepted laboratory practices there is no
scientific data regarding the painful or distressing effects on either
people or animals.
A lack of data on the recognition, assessment, alleviation, and
prevention of pain and distress in laboratory animals is commonly cited
by scientists as a rationale for either not reporting pain and distress
or not acting to mitigate it. This lack of data is obviously
detrimental to the welfare of animals used in research, but it is also
detrimental to the quality of science produced. Uncontrolled,
undetected, and unalleviated pain, physical distress, or psychological
distress result in alterations in physiologic and behavioral states,
and confound the outcome of scientific research. Ultimately, the lack
of information on pain and distress leads to misinterpretation of
research results that could result in harmful effects in human beings
when pre-clinical animal research results are applied to humans in
clinical trials. It is worth noting that researchers themselves often
comment publicly at scientific meetings about the urgent need for
funding in order to properly understand and mitigate pain and distress
in research animals.
Our nation takes pride in leading the world in biomedical research,
yet we lag behind many other countries in our efforts to minimize pain
and distress in animal subjects. For example, the United Kingdom,
Sweden, Switzerland, Germany, the Netherlands and the European Union
all have committed funds specifically for the ``three R's'' (replacing
the use of animals, reducing their use, and refining research
techniques to minimize animal suffering).
We urge the Committee to make this small investment of $2.5 million
to promote animal welfare and enhance the integrity of scientific
research. We also respectfully request this accompanying committee
report language:
``The Committee provides $2.5 million for the National Center for
Research Resources to support research and development focused on
improving methods for recognizing, assessing, and alleviating pain and
distress in research animals. No pain and distress should be inflicted
solely for the purpose of this initiative, since the investigations can
and should be conducted in conjunction with ongoing research that is
believed to involve pain and distress under Government Principle IV of
Public Health Service Policy, which assumes that procedures that cause
pain and distress in humans may cause pain and distress in animals.''
Again, we appreciate the opportunity to share our views and top
priority for the Labor, Health and Human Services, and Education
Appropriation Act of fiscal year 2005. We hope the Committee will be
able to accommodate this modest request that will benefit animals in
research and the quality of the research. Thank you for your
consideration.
______
Prepared Statement of the Society of Nuclear Medicine
The Society of Nuclear Medicine (SNM) appreciates the opportunity
to submit written comments for the record regarding funding for
workforce education and training and biomedical research related
programs in fiscal year 2005. SNM is an international scientific and
professional organization founded in 1954 to promote the science,
technology and practical application of nuclear medicine. Its 14,000+
members are physicians, technologists and scientists specializing in
the research and practice of nuclear medicine.
To that end, SNM advocates ongoing and significant federal funding
for programs to help ensure an adequate nuclear medicine workforce to
care for the nation's citizens as well as increasing the our investment
in biomedical research. The Society stands ready to work with
policymakers at the local, state, and federal levels to advance
policies and programs that will reduce and prevent suffering from
disease.
WHAT IS NUCLEAR MEDICINE?
Nuclear medicine is a medical specialty that involves the use of
small amounts of radioactive pharmaceuticals, called ``Radiotracers''
or ``Tracers,'' to help diagnose and treat a variety of diseases. These
tracers are detected by special types of cameras that work with
computers to provide nuclear medicine physicians and the patient's
doctor precise pictures of the area of the body being imaged. It is a
way to gather medical information that may otherwise be unavailable,
require exploratory surgery, or necessitate more expensive diagnostic
tests.
Nuclear medicine procedures, such as PET (positron emission
tomography) and SPECT (single-photon emission tomography), often
identify abnormalities very early in the progression of a disease--long
before some medical problems are apparent with other diagnostic tests.
This early detection allows a disease to be treated early in its course
when there may be a more successful prognosis.
An estimated 16 million nuclear medicine imaging and therapeutic
procedures are performed each year in the United States. Nuclear
medicine procedures are among the safest diagnostic imaging tests
available. The amount of radiation from a nuclear medicine procedure is
comparable to that received during a diagnostic x-ray.
Some of the more frequently performed nuclear medicine procedures
include:
--Bone scans to examine orthopedic injuries, fractures, tumors or
unexplained bone pain.
--Cardiac scans to identify normal or abnormal blood flow to the
heart muscle, measure heart function or determine the existence
or extent of damage to the heart muscle after a heart attack.
--Breast scans which are used in conjunction with mammograms to more
accurately detect and locate cancerous tissue in the breasts.
--Liver and gallbladder scans to evaluate liver and gallbladder
function.
--Cancer imaging to detect tumors and determine the severity
(staging) of various types of cancer.
--Treatment of thyroid diseases and certain types of cancer.
--Brain imaging to investigate problems within the brain itself or in
blood circulation to the brain.
--Renal imaging in children to examine kidney function.
securing and maintaining an adequate nuclear medicine workforce
The field of nuclear medicine is not attracting enough incoming
students to fill the current demand for nuclear medicine technologists
(NMTs). Currently, there is approximately an 18 percent vacancy of NMTs
as determined by the American Hospital Association (AHA). By 2010, the
Bureau of Labor Statistics (BLS) projects that the United States will
need an additional 8,000 NMTs to fill the projected demand created by
the aging workforce and expanding senior population. Over the next 20
years, the BLS expects that there will be a 140 percent increase in the
demand for imaging services. The use of diagnostic imaging services has
been increasing by approximately 4 percent a year, even as the number
of certified NMTs and registered radiologic technologists has remained
stable. As a result, imaging technologists often work longer shifts and
patients can face weeks of delay for routine exams.
A similar situation to the shortage of NMTs is developing for
nuclear medicine physicians. According to the American Board of Medical
Specialties (ABMS), there currently are 4,087 certified nuclear
medicine physicians in the United States. At the same time, the number
of physician training programs is also declining, exacerbating the
future shortage.
Over the next 20 years, the number of people over the age of 65
with cancer is expected to double at the exact same time the nation
will face shortages of medical personnel--including NMTs, physicians,
nurses, laboratory personnel, and other specialists. New technology and
an aging population have increased demand for NMTs, but personnel
capacity is not keeping pace with the need. With an increasing number
of people needing specialized care--such as nuclear medicine--coupled
with an inadequate workforce, our nation faces a health care crisis of
serious proportion with limited access to quality health care,
particularly in traditionally underserved areas.
The workforce education and training programs at the Health
Resources and Services Administration (HRSA) have created a network of
initiatives across the country that supports the training of many
disciplines of health providers. These are the only federal programs
designed to create infrastructures at schools and in communities that
facilitate customized training designed to bring the latest emerging
national priorities to the populations at large and meet the health
care needs of special, underserved populations.
These important workforce education and training programs are
designed to increase access to health care in underserved areas by
improving the quality, geographic distribution, and diversity of the
health care workforce. To that end, SNM recommends funding of at least
$550 million to fulfill this mission in the fiscal year 2005.
Additionally, the number of residency slots for training physicians
in nuclear medicine is declining. The Society urges Congress to
establish a nuclear medicine residency-training fund of $2 million per
year for 5 years. This fund would provide 50 residency training
positions each year to be used for an additional year of nuclear
medicine training of radiology residents and additional 2-year nuclear
medicine residencies. This addition of trained physicians will help
ease the work force shortage and add to the number of available
radiation protection experts in the event of a dirty bomb or other
radiation incident.
SUSTAIN AND SEIZE RESEARCH OPPORTUNITIES
Our nation has profited immensely from our past federal investment
in biomedical research at the National Institutes of Health (NIH). SNM
is proud to join with the rest of the public health community in
advocating $30.19 billion for the NIH in fiscal year 2005. This
increase of 8.5 percent over fiscal year 2004 funding will allow NIH to
sustain and build on its research progress resulting from the recent
NIH budget doubling effort while avoiding the severe disruption to that
progress that would result from a minimal increase.
The first successful nuclear magnetic resonance (NMR) experiments
were performed in 1946 leading to the first nuclear magnetic resonance
imaging (MRI) exam was performed on a human being in 1977. Critical
advances in technology development now allow physicians to image in
seconds what used to take hours. Research in biomedical imaging and
bioengineering is progressing rapidly and recent technological advances
have revolutionized the diagnosis and treatment of disease. Therefore,
SNM requests $325 million for the National Institute of Biomedical
Imaging and Bioengineering (NIBIB) to further the Institute's research
in the development and application of emerging and breakthrough
biomedical technologies that will facilitate improved disease
detection, management, and prevention.
Cancer research is producing extraordinary breakthroughs--leading
to new therapies that translate into longer survival and improved
quality of life for cancer patients. We have seen extraordinary
advances in cancer research resulting from our national investment that
have produced effective prevention, early detection and treatment
methods for many cancers. To that end, SNM asks the Committee to
allocate $6.2 billion for the National Cancer Institute (NCI) in fiscal
year 2005 as recommended by the NCI Director in the Bypass Budget
submitted to Congress annually under the requirements of the National
Cancer Act of 1971. The Bypass Budget represents the best estimation of
the scientific community regarding the resources needed to continue our
battle against cancer.
CONCLUSION
The Society of Nuclear Medicine once again stands ready to work
with policymakers to advance policies that will reduce and prevent
suffering from disease for all Americans, while ensuring an adequate
nuclear medicine workforce. Again, we thank you for the opportunity to
present our views on funding for nuclear medicine workforce and
research related programs and stand ready to answer any questions you
may have.
______
Prepared Statement of the National Prostate Cancer Coalition
Mr. Chairman and members of the Committee, thank you for the
opportunity to share my remarks. The National Prostate Cancer Coalition
(NPCC) was founded in 1996 to combat a long overlooked killer of men. I
came to NPCC in 2001, having just recently been impacted by the disease
myself. In 2000, my grandfather was diagnosed with prostate cancer.
Having served his country so valiantly in World War II, he was now
facing a new battle. Luckily, because of early detection through the
prostate specific antigen (PSA) test and the digital rectal exam (DRE),
the disease was caught early and, following a radical prostatectomy, he
is now cancer free. But there are many men who are not so lucky. That's
why you must adequately fund prostate cancer research for veterans like
my grandfather, families like mine, and men all over America.
Under the leadership of this committee we have seen prostate cancer
research funding increase by nearly $300 million since in the last 6
years. While we have come a long way, there is still much work to be
done. For the first year since the founding of NPCC, prostate cancer
deaths will increase in 2004. Nearly 30,000 lives will be lost to the
disease. Occurrences of prostate cancer are increasing as well, to over
230,000 men this year. While cases continue to grow, more men are
catching the disease in its early stages, when the disease is most
treatable, by early detection through screening.
NPCC would like to offer its gratitude on behalf of the 2 million
American men with prostate cancer for the support this committee has
offered in the past. The recent doubling of the National Institutes of
Health's (NIH) budget has helped prostate cancer research funding to
expand to record levels, but we must ensure this funding is used
appropriately. To that end, your committee was instrumental in
requiring NIH and the National Cancer Institute (NCI) to submit a
professional judgment budget for fiscal year 2003-fiscal year 2008 to
outline the agencies' plans for prostate cancer research. You have also
been influential in requesting a fiscal budget for that document, which
is expected to be submitted to the Committee by April 2004 (Senate Rpt.
108-081). While no one disputes the historic importance of doubling, we
ask you to use your oversight capacity to ensure this funding is
producing results for prostate cancer. Huge sums of taxpayers' money
have been allocated to NIH over the years and it is now time to examine
what this windfall has produced. Therefore, we request that you ask NIH
to submit a yearly update on its prostate cancer research portfolio
that reflects its progress according to the fiscal year 2003-fiscal
year 2008 professional judgment budget.
We are entering an exciting time in biomedical research. The recent
Food and Drug Administration's approval of Avastin has opened a new
door for cancer research. Avastin targets cancerous cells by blocking
their blood supply, an idea that had been previously dismissed by the
medical community as ``absurd.'' The drug not only signals a turning
point in changing cancer into a manageable, chronic disease but also
demonstrates the value of seeking out novel and innovative research. We
must encourage this kind of research at NIH, including assessing the
value of stem cell research which has shown promise in research for
neurological diseases, diabetes, and cancer.
Developing a new approach to research is a priority for NPCC. The
Prostate Cancer Research Funders Conference, first convened in 2001 and
then revitalized last fall, seeks to formulate a collaborative, public-
private approach to seek out new ways of attacking the problem of
prostate cancer. Originally co-convened by NPCC and NCI, participants
now also include the Department of Defense, the Veterans Health
Administration, the Centers for Disease Control and Prevention, the
Food and Drug Administration, Canadian and British government agencies,
private foundations/organizations and representatives from industry.
Members of the Conference have come together to form a partnership that
allows them to focus on key objectives and to address commonly
recognized barriers in research. This could propel research forward
significantly. As the Conference continues, we ask that the Committee
make its functionality part of its oversight commitments to prostate
cancer research. Currently, federal agencies participate voluntarily,
but they can opt in or out based on the tenure of executive leadership
and its time-limited decisions. For the conference to be successful
federal agencies engaged in the prostate cancer research should, in our
opinion, be required to participate, and we ask for your leadership to
make that happen.
Recognizing the importance of cutting edge research initiatives and
collaborative research efforts, NIH director Elias Zerhouni, M.D.
recently unveiled the NIH Roadmap. The Roadmap's strategy mirrors that
of the Funders Conference, specifically by seeking out new approaches
and ideas and stimulating cross-institutional and cross-center research
for all NIH driven biomedical research. Believing, we think correctly,
that the synergies in the Roadmap can achieve outcomes that are greater
than those any one Institute or Center can achieve, we support its
efforts to advance key biomedical research initiatives at an
exponential rate. NPCC applauds the Roadmap and pledges its support to
take biomedical research in new directions.
As NIH and NCI look to redefine and increase the efficiencies of
their research programs, Congress must equip them with the resources
they need to implement new initiatives. Unprecedented increases in NIH
and NCI's funding over the last 6 years have created opportunities
never before available. We must take advantage of these achievements,
to not do so will not only harm cancer patients everywhere but is,
quite simply, poor business sense.
In his fiscal year 2005 budget, President Bush has requested a 2.6
percent increase ($28.8 billion) in NIH funding over the fiscal year
2004 level. Over the past 30 years, the agency has averaged an annual
growth rate of 8 percent. Leading biomedical research groups like the
Federation of American Societies for Experimental Biology (FASEB) have
stated if increases are held to 2 percent-3 percent the grant funding
rate at NIH will drop below 30 percent and approximately 500 fewer
grants would be funded. To allow NIH and NCI to adequately continue to
fund promising grants and research first realized during the budget
doubling, Congress must appropriate at least an 8.5 percent increase
($30.25 billion) in funding for these agencies in fiscal year 2005.
That may seem like a large number, but in reality, it is only a small
fraction of the estimated $189 billion that cancer alone costs this
nation yearly.
Increasing NIH's budget by 8.5 percent would also allow NCI to
dedicate more than $400 million to prostate cancer research in fiscal
year 2005. Last year, NCI received only a 3.3 percent increase in
funding over the previous year's level. Yet, with previously committed
grant awards and outlays to the NIH Roadmap, NCI is ``effectively
operating with a budget that is $2.7 million less than last year's
operating budget (NCI Cancer Bulletin 2/3/04).'' The President's fiscal
year 2005 budget allocates $4.87 billion to NCI, slightly less than the
fiscal year 2004 increase. This level will mean even tougher choices in
awarding grants at NCI. We believe that Congress should fully fund the
NCI Director's Bypass Budget at $6.2 billion, which would rapidly
accelerate the nations' fight against all cancers.
As you know, education and early detection through screening are
the catalyst to beating prostate cancer. Right now, the PSA blood test
and DRE physical exam are the best measures for detecting prostate
cancer early. We ask the Committee to allocate at least $20 million to
the Center for Disease Control and Prevention's (CDC) prostate cancer
awareness program. We also encourage the Committee to work with CDC to
address our concern that the agency places insufficient value on these
screening tools.
Thank you again for the leadership you have shown in advancing
biomedical and, more specifically, prostate cancer research. Under your
leadership, the nation's war on cancer has reached heights never before
realized. We look forward to continuing to work with you and the
members of the Committee until a cure is found.
______
DEPARTMENT OF EDUCATION
Prepared Statement of the Southern Methodist University School of
Engineering
Mr. Chairman and Members of the Subcommittee, I am very grateful to
be able to offer testimony on the importance of maintaining our global
economic leadership position through a wise and sustained investment in
engineering education. And, I want to share with you the early success
of a program called the Texas Engineering and Technical Consortium that
has emerged as a national model for increasing the technical
capabilities of our workforce.
As you know, engineering and technology is an important engine of
our national economy. The innovations created by our working engineers
have fueled the information revolution, increased our national
security, brought more efficient health care, and created a larger food
supply to the world.
Our remarkable engineering successes have been the product of our
talented and highly skilled technical workforce. Unfortunately, recent
national trends don't bode well for increasing the number of homegrown
high-tech workers. A 2003 national survey \1\ showed that the level of
interest in engineering majors by college bound high school seniors has
declined by 37 percent over the last 12 years. Sadly, this is a
uniquely American phenomenon; much of the rest of world understands how
important an engineering and technical workforce will be to their long-
term economic health. Within the decade, some predict that India and
China together could graduate nearly 1 million engineers per year, a
number 20 times greater than the production of engineers here in the
United States.
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\1\ ``Maintaining a Strong Engineering Workforce,'' ACT Policy
Report, authors R. Noeth, T. Cruce, and M. Harmston, 2003.
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The recently released Hart-Rudman report for the U.S. Commission on
the National Security/21st Century says:
``The harsh fact is that the United States need for the highest
quality human capital in science, mathematics, and engineering is not
being met.'' \2\
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\2\ Road Map for National Security: Imperative for Change, The
Phase III Report of the U.S. Commission on the National Security/21st
Century, pp. 30, February 15, 2001.
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Why is This Important to Both Texas and the Nation?
Engineering and technology have been drivers of the Texas and
national economy for nearly 100 years. With the discovery of oil at
Spindletop by Austrian born engineer Francis Lucas to the kick-start of
the high tech industry by Jack Kilby's invention of the integrated
circuit in Dallas, Texas engineers have had a profound and historic
impact for both our state's and nation's economy. And today, Texas is a
major hub for engineering innovation--employing nearly half a million
high tech and engineering workers, with annual wages of $36 billion,
while exporting $29 billion in goods and services.
Yet today, this important and large industry is being replenished
by only 4,500 new college graduates in engineering and computer
scientists each year. This reality will impact all of us. For example,
over the next decade, the Joint Strike Fighter program based at
Lockheed Martin in Ft. Worth, expects to hire twice as many engineers
each year than the entire state produces. This workforce imbalance is
bad for Texas and bad for our nation. Our only hope for maintaining
global leadership in engineering innovation is to invest today in the
education of the best, most diverse, population of engineers in the
world.
A CALL TO ACTION: CONTINUE INVESTING IN SUCCESSFUL PROGRAMS LIKE THE
TEXAS ENGINEERING AND TECHNICAL CONSORTIUM
Fortunately, I am happy to report that the Texas Engineering and
Technical Consortium, which you supported in last year's budget at $3
million, is beginning to pay real dividends. Texas Senators Kay Bailey
Hutchison and John Cornyn led the way in supporting our request for
federal resources to match state and corporate contributions.
This innovative effort, aimed at doubling the number of engineers
and computer scientists graduating from our universities, is already
having a significant impact. In fact, The Infinity Project, one program
funded by TETC that I direct, is having a profound effect on national
engineering education at the high school level--a key barrier to
college success. This award winning engineering curricula has increased
high school students' interest in engineering by 40-fold in schools
that offer the program. And there are other great examples as well.
The wise investments of the state and federal government, along
with high-technology companies of Advanced Micro Devices (AMD), Applied
Materials, Hewlett-Packard, Intel, International SEMATECH, Lockheed
Martin, Motorola, National Instruments, National Semiconductor, Sabre,
and Texas Instruments is changing how Texas universities identify,
recruit, educate, and mentor tomorrow's engineers. Through these
efforts, TETC is establishing a national model for other states to
follow as they address their own workforce needs.
But I am here to tell you that our work has really just begun. As a
nation, we have struggled for decades to attract a diverse set of well-
prepared students to the exciting world of engineering, math, and
science. Permanent solutions to this problem have been elusive--and
further still, programs that have shown promise often don't get the
sustained funding necessary to have a real impact.
Therefore, on behalf of the 34 Texas universities and industry
leaders participating in TETC, I ask that you continue investing in the
Texas Engineering and Technical Consortium.
The program is sound and successful. I ask you to help make our
progress sustainable.
CONCLUSION
I want to thank Chairman Arlen Specter, Ranking Member Tom Harkin,
Members of the Subcommittee and, of course, Senators Hutchison and
Cornyn once again for supporting TETC. On behalf of all of us across
this nation who care deeply about the economic health of our country, I
appreciate your interest in improving the quantity, quality, and
diversity of America's technical workforce.
______
Prepared Statement of the K-12 Science, Technology, Engineering &
Mathematics Education Coalition
We encourage you to continue the federal commitment to math and
science education by maintaining the peer-reviewed Math and Science
Partnerships (MSPs) at the National Science Foundation (NSF) and
supporting robust funding for both the U.S. Department of Education
(ED) and the NSF Math and Science Partnership programs.
We urge you to oppose the Administration's budget proposal that
would phase-out the NSF MSP program and establish a new federal grant
administered by the Secretary of Education that would, in effect, limit
individual states' discretion to target much-needed funds for local
science and mathematics education reforms.
We believe that the MSPs at both the Department of Education and at
NSF are necessary and complementary. Without one, the other is
significantly weakened.
The competitive, peer-reviewed, NSF MSPs seek to develop
scientifically sound, model, reform initiatives that will improve
teacher quality, develop challenging curricula, and increase student
achievement in mathematics and science. The funds appropriated under
NCLB for the ED MSPs go directly to the states as formula grants,
providing funds to all states to replicate and implement these
initiatives throughout the country.
While we support the Administration's proposal to increase funding
for the ED MSPs, we oppose the creation of a new $120 million ED grant
program that runs counter to congressional intent by focusing only on
math and reducing state flexibility to target funds to areas of
greatest need. We encourage you to oppose new restrictions on the
additional funding slotted for the state-based ED MSPs.
In summary, we strongly urge Congress to:
--reject the Administration's proposed phase-out of the NSF MSP
program;
--oppose additional restrictions to the ED MSP program; and,
--provide robust funding for both MSP programs.
If you have any questions, please contact Patti Curtis at 202-785-
7385.
______
Prepared Statement of Americans for the Arts
REQUEST
Americans for the Arts is pleased to submit testimony supporting
fiscal year 2005 appropriations of $53 million for the Arts in
Education program of the U.S. Department of Education (USDE).
Americans for the Arts is one of the leading national nonprofit
organizations for advancing the arts and arts education in America.
With a 40-plus year record of objective arts industry research, we are
dedicated to representing and serving local communities and creating
opportunities for every American to participate in and appreciate all
forms of the arts. Our belief in the importance of practical research
causes us to take special pleasure in supporting USDE's Arts in
Education program, which is generating impressive evidence on the best
ways to improve overall academic achievement by integrating the arts
into the school curriculum. The evidence of improved academic
achievement is itself impressive. For example:
--Mississippi's Whole School Initiative found that schools with a
high degree of implementation far surpassed other schools in
their ability to meet No Child Left Behind (NCLB) reading
targets.
--In Houston, analysis showed that students in participating
elementary schools out-performed their demographic peers on the
Iowa Test of Basic Skills, and that the benefits lasted beyond
graduation and on into middle school.
We have provided more detailed information on the Mississippi
example below.
As members of the Subcommittee know, the Elementary and Secondary
Education Act provides that funding up to $15 million be directed to
the John F. Kennedy Center for the Performing Arts and VSA arts. Prior
to fiscal year 2001, funding never exceeded that level. Since fiscal
year 2001, however, Congress has appropriated funding sufficient to
support a broader array of arts education programs. For fiscal year
2004, Congress appropriated $35.1 million. In addition to the Kennedy
Center and VSA arts, USDE now supports grants competitions to:
--further develop established arts education models;
--support professional development for arts educators in four arts
disciplines; and
--establish partnerships between schools and community cultural
organizations to serve at-risk children and youth.
We ask the Subcommittee to appropriate $53 million for fiscal year
2005, with the bulk of the increase to be allocated to the Arts in
Education Model Development and Dissemination Program, Professional
Development training in music, theater, dance and the visual arts, as
well as Cultural Partnerships for At-risk Children and Youth.
FOUR REASONS TO INCREASE ARTS EDUCATION FUNDING
The most important reason to support arts education is simply
stated: arts education works for children. Research increasingly
confirms its beneficial effects in several areas, including but not
limited to academic achievement. We refer the Subcommittee to a
research compendium Critical Links: Learning in the Arts and Student
Academic and Social Development,\1\ released by the Arts Education
Partnership in 2002, which includes 62 separate studies pointing to
``critical links'' between arts education and reading, writing,
mathematics, cognitive skills, motivation, social behavior, and the
school environment. The studies suggest that arts education may be
especially useful for students who are economically disadvantaged and/
or in need of remedial instruction.
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\1\ http://www.aep-arts.org/CLTemphome.html
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The second reason to increase funding is that schools desperately
want it. Even now, when the accountability and testing regimens of NCLB
have focused schools' attention on what some call ``the basics,'' many
schools understand that the arts are a core academic subject, as NCLB
indeed stipulates, that they are essential, and that they work. The
Department of Education's first model grant competition generated a
flood of applications despite the tiny number of awards. A larger
amount of funding, coupled with a smaller grant size, will at least
begin to address the demand. Unfortunately, without an increase in
funding, USDE will be unable to hold a new grant competition for 2
years.
The third reason is that while there is tremendous interest in arts
education, substantial improvements need to be made to delivery
systems. USDE's model grants program aims to further develop
established programs that improve arts education, to evaluate these
programs, and to disseminate the results. Thus, it is in accord with a
central principle of the federal role in education: to find out what
works and to disseminate this information to states and local school
districts so that they may select and tailor programs to fit their own
needs and circumstances. This is the reason that we urge the
Subcommittee to recommend that funding include at least $1 million for
evaluation and dissemination. We note that each of the projects funded
under this program include a substantial research component. It is
particularly important to add this modest amount of funding because the
USDE's existing and planned research efforts, including the What Works
Clearinghouse, do not include substantial work on arts education.
Finally, despite increases in overall federal spending for K-12
education, and despite the substantial flexibility given to states,
evidence is beginning to accumulate that schools are neglecting those
areas of the curriculum that are not subject to the mandatory testing
requirements of NCLB. The National Association of State Boards of
Education (NASBE) identified the threat in its 2003 report The Lost
Curriculum; \2\ in response, NASBE's current quarterly policy journal,
the State Education Standard,\3\ is devoted entirely to ``ensuring a
place for the arts in America's schools.'' Earlier this month, the
Council for Basic Education released a survey \4\ of school principals
in four states: fully one quarter of them report that they have
decreased instructional time in the arts. Unfortunately--and perhaps
even tragically--the shift away from the arts appears most concentrated
in elementary schools and schools with large minority populations. We
have supported NCLB, especially its inclusion of the arts as a core
academic subject, and we believe that the problems facing arts
education are a consequence that is very much unintended. Nevertheless,
the problems are real and must be addressed. USDE's model development
program--if there is sufficient funding for national dissemination--
provides principals with desperately needed information on how to
integrate the arts into the curriculum in a way that improves academic
achievement.
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\2\ http://www.nasbe.org/Research_Projects/Lost_Curriculum.html
\3\ http://www.nasbe.org/Standard/index.html
\4\ http://www.c-b-e.org/PDF/cbe_principal_Report.pdf
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CASE EXAMPLE: MISSISSIPPI'S WHOLE SCHOOLS INITIATIVE
In our testimony for fiscal year 2004 funding, we provided
extensive information on structure and philosophy of the Whole School
Initiative in Mississippi. This year, we can provide a preliminary
analysis for the project's final evaluation report, which is due in
June.
Recap of the Whole Schools Initiative
In 2001, the Whole Schools Initiative was 1 of 11 successful
applicants for a grant from USDE's Arts in Education Model Development
and Dissemination Program. The program's roots go back to 1991, when as
a response to ``back to basics'' school reform and the lack of arts
instruction in Mississippi, the Mississippi Arts Commission (MAC)
commissioned a study of the Mississippi environment, appropriate
national arts education models and relevant research. A pilot program
began in 1992.
The Whole Schools Initiative was launched in 1998 with a core
belief that art is essential to every child's education. It is the
first comprehensive statewide arts education program in Mississippi.
Its goals are to improve student academic achievement by infusing arts
into the basic curriculum, to assist the professional and personal
growth of teachers and administrators through arts experiences, to use
the arts to increase parental and community involvement in schools and
to assist schools in building a sustainable system for supporting arts
infusion. Partnerships include local arts councils, Institutions of
Higher Learning, the Mississippi Alliance for Arts Education,
professional artists, local school districts and art museums.
Not only does the program improve the quality of arts education
being offered in participating schools, it is often the only chance
that Mississippi children, in poorly funded schools and from families
living below the poverty level, will ever have to receive any
formalized arts instruction. Nineteen of the initiative's 26 schools
serve student populations where 35 percent or more of the students
qualify to receive free/reduced lunches, fourteen schools have at least
70 percent and seven have at least 90 percent. Eleven schools involved
in the initiative are located in rural communities and others serve
them. Six of these schools have the lowest per pupil expenditure in the
state.
This $1 million grant has allowed MAC to expand its role with
universities, encouraging the development of pre-service courses that
to strengthen arts infused instruction and aid arts majors in becoming
effective instructional leaders. The grant has also enabled MAC to
expand and refine its evaluation model. A final component of the USDE
funding is allowing MAC to develop training materials and procedures
that can be used to replicate the program in other settings. At the end
of the 3-year grant period, the project will ``blueprint'' a model
built on a research base, field-tested in a diverse set of schools,
evaluated internally and externally, and which has already produced
substantive results.
This funding has made possible extensive professional development
opportunities for teachers and administrators. More than 15,000
students and 800 educators benefit annually from activities at a
weeklong summer institute, two retreats, and field advisor visits.
Other ways in which it is strengthening the program include a course
for education majors that is being developed at the Delta State
University, a ``teacher friendly'' and ``teacher useful'' interactive
web site, and the designation of model schools in the north, central,
and southern regions of Mississippi where the initiative's work may be
observed.
Other states will benefit from the documentation and dissemination
of the initiative. Many states have a strong interest in implementing
this model but lack the resources, knowledge, and experience to do so.
States that have approached MAC and participated in the institute
include New Mexico, Illinois, Kentucky, Florida, and Louisiana.
Preliminary Results of the Whole Schools Initiative
The preliminary analysis looks closely at WSI participating
schools' NCLB performance in literacy, which was reported for the first
time in the fall of 2003. Literacy was chosen as the analytic focus
because most of the examined schools were elementary school buildings
and learning to read was the foremost concern at that level. The first
part of the analysis examines the performance of the 25 participating
schools in the spring of 2003 and compares their results to the state
average and to a matched set of comparison schools. The second examines
a subset of 18 sites that: (1) completed a teacher survey concerning
the implementation and impact of the initiative and (2) had grade
levels that were included in the reporting requirements of NCLB.
The analysis suggests that two conclusions are warranted. First,
schools attempting to create an arts-rich environment for their
students performed as well as--if not slightly better than--both the
state average for all Mississippi schools and a comparison group of
schools demographically and geographically similar to themselves.
Second, schools whose teachers reported higher implementation of WSI
objectives far surpassed lower implementation schools in enabling their
students to meet the all-important growth targets of NCLB. The
implication of the analysis is that rather than stripping the
curriculum of all but basic direct instruction in literacy and math
under the spotlight of making adequate yearly progress, schools might
consider enriching the learning environment with multiple opportunities
to learn in the arts.
CONCLUSION
As the example of the Whole Schools Initiative demonstrates,
federal funds boost the quality and quantity of support for arts
education as well as the knowledge that can be gained and disseminated
across the education establishment. Increased funding means more help
for state departments of education, educators in schools, and local
education agencies and cultural organizations. Most important, it means
a better education for our children. We urge the Senate Subcommittee on
Labor, Health and Human Services, and Education to recommend $53
million in funding for the USDE's Arts in Education programs in order
to allow more programs like Mississippi's Whole Schools Initiative to
flourish.
______
Prepared Statement of the Close Up Foundation
Mr. Chairman and distinguished members of the Subcommittee, my name
is Stephen A. Janger, and I am president and founder of the Close Up
Foundation. I am grateful for the opportunity to submit testimony in
support of the Close Up Fellowships, previously known as the Allen J.
Ellender Fellowships, which help low-income students and their
participating teachers take part in our Close Up Washington civic
education programs. On behalf of my colleagues at the Foundation and
hundreds of thousands of young people and educators who have
participated in Close Up through the years from school systems across
the country, I want to express my appreciation for this Subcommittee's
longstanding encouragement and support.
As you may recall, in my testimony last year, I described the
impact of world events on Close Up's work--specifically, September 11
and the more recent hostilities in Iraq. We saw a decline in our
program enrollments because of fear of travel to Washington, D.C., and
subsequent travel bans. I am pleased to let you know that program
enrollments appear to be improving and we are seeing a modest increase
in participation over last year. I want to let you know also that we
are doing all we can to broaden efforts to encourage participation in
our civic education programs, knowing that our mission is more
important and vital than it has been since our inception in 1971. We
have reason to believe, based on our conversations with teachers and
school districts, that next year will see an even more significant
enrollment expansion because of the continued easing of travel
anxieties and the relaxation of school travel bans.
The heart of our mission is the conduct of Close Up's weeklong
program in Washington, D.C. During this program, students receive 12 to
14 hours of civic instruction and educational activities each day. Led
by our trained Program Instructors, young people learn in a ``living
classroom'' environment through study visits to Capitol Hill,
embassies, and many of the country's most historic and symbolic sites.
Policy specialists, journalists, lobbyists, and other insiders help
show students how government works. Close Up's instructors add to these
seminars by teaching the basics of government and citizenship through
highly engaging role-playing, workshops, discussion groups, and
simulations.
The centerpiece of the program is typically a face-to-face meeting
with Members of Congress or your staffs. They are able to engage in a
dialogue with an elected official or staff member ``close up.'' In
addition, students often see floor debates and committee hearings. They
come to understand the process of government, may feel a bit less
intimidated about how it works, and can begin to see that they have a
role in the future of our democracy.
The difficult reality is that it has become more expensive to make
this unique opportunity available for students from every background
because the costs from even the most competitive vendors continue to
increase. To pay for these experiences, our young participants, who
come from very varied backgrounds and represent a wide range of
academic performance, often start fundraising during their freshman and
sophomore years to attend the program in their senior year. They
generate funds from community contributions, fundraising activities,
and old fashioned work to support the costs of travel and program
tuition.
Not every Close Up participant is fortunate to come from an
affluent background. Our work with Native Americans, Alaska Natives,
Hispanics, African Americans, migrant students, the physically
challenged, and students who are long-term cancer survivors takes us
each year into populations with need for special help to make possible
their participation. During my 34 years at Close Up, I have seen tens
of thousands of these student-participants who have been able to
participate in our Close Up Washington program only because of the
Close Up Fellowships. The support of this Subcommittee not only covers
up to half of a needy student's program, it serves as a meaningful
``jump start'' for the student who seeks additional support from local
businesses, parents, schools and community organizations. In this way,
the Fellowships have a significant multiplier effect at the community
level.
The Carnegie Foundation published last year a highly collaborative
report called ``The Civic Mission of Schools.'' It may be the most
significant statement in the civic education field in the last decade.
It makes a strong case for making civic education much more of a
priority in our elementary and secondary system of education. It also
singles out practices, such as the experiential methodology of Close
Up, as having the most effect. It also suggests that schools themselves
cannot do it all by themselves. Partnerships, collaborations, use of
external resources all can help schools better achieve their civic
mission.
Beyond the funding support we work to generate each year from the
corporate and philanthropic sectors, we could not be more proud of the
partnerships we have been able to forge with states, districts, and
individual schools. These partnerships not only provide a number of
individual students and teachers with the opportunity to take part in
Close Up's Washington program, but also to use this experience as a
means of strengthening the entire curriculum and extracurricular
activities as well in the area of civic education. This is another
strong example of the multiplier effect.
I believe strongly that schools are still the best tool for
instilling civic virtue and that community service, service learning,
and participation in the development of public policy are essential
training tools for good citizenship. With that in mind, I want to take
this opportunity to briefly describe one of our programs that holds
tremendous potential for growth.
Several years ago, we decided that our work with inner city schools
needed greater focus and intensity. To that end we developed strong
working relationships and raised significant extra financial support to
dramatically increase the amount of fellowship resources for the major
urban public school districts in Washington, D.C., Houston, and Tulsa.
Within this current year, we have added Atlanta and Miami to this new
series of program activities we call the Great American Cities Program.
Students receive a great deal of financial assistance from
community support, and much is expected of them both before and after
their Washington program experience. Students develop and implement
community projects that contain in some form a public policy dimension.
Teachers receive in-service training, led by our own staff and other
experts, on how to foster and develop these programs. This is another
example of the multiplier effect where Close Up Fellowships have
provided through the years a partnership with school districts that
enabled the launch of an innovative and effective program.
As you will read in a few testimonials following this statement--
selected from the thousands we receive each year--Close Up's work with
young people and educators provides inspiration, reduces cynicism and
enhances understanding about the democratic process. Students see
firsthand how individuals make a difference and that they themselves
can leave things a little better than they found them.
Close Up was started more than three decades ago in another era of
conflict to help address the disillusionment expressed by many young
Americans during the Vietnam War. Our work has remained both relevant
and effective, and is needed now more than ever. America today is faced
with many policy choices, both international and domestic, that
threaten to divide us. A greater dialogue among a thoughtful and
patriotic citizenry is needed to help pull our country together. This
has been our goal since our inception: to create a public of engaged,
informed, and responsible citizens that Jefferson believed was the most
important outcome of our nation's schools.
In closing, Mr. Chairman, I want to thank this Subcommittee for its
strong support through the years. The nation's civic education efforts
cannot afford to take a back seat to other curricula objectives. These
efforts should underlie our important focus on literacy and science
testing. It should be second nature to our young people that the
blessings of this great country, and the responsibilities to sustain
those blessings through active involvement in the democratic process,
are the bedrock values and principles from which the liberties of
personal and academic freedom are derived. These values and these
principles are what set us apart as a nation.
The Close Up Foundation takes great pride in its national
leadership in these values and principles from which we have never
deviated since we began in 1971. The vital funding that we have
received from this Subcommittee through the years, combined with our
own efforts in the private sector to multiply that funding, has made it
possible for hundreds of thousands of young people and their teachers
representing every kind of background to understand and appreciate
these core values and principles. Your continued support at an
increased level for the Close Up Fellowships will help us do more--
where it is most needed.
We respectfully request that this Subcommittee increase the Close
Up Fellowships to a level of $4 million. This will enable us to
multiply our efforts even further, so that those who are most often
neglected or turned away from the civic involvement mainstream are
brought into the democratic process. This is fundamental to our
mission.
Thank you, Mr. Chairman, for your consideration of this request.
TESTIMONIALS OF CLOSE UP PARTICIPANTS
``I truly believe that your program is the most educational
governmental program available to students in the United States. With
the additions of teacher fellowships as well as student fellowships we
are able to encourage and in fact provide for opportunities to all our
students regardless of economic status or academic levels.''----Todd
Lee, Teacher, 2004 Tioga High School, Tioga, North Dakota.
``Many members of my staff have had an opportunity to met with a
number of these students and their participating teachers directly. The
feedback has been overwhelmingly positive. We are all pleased with the
excitement for learning expressed about the program. We have also met
regular with the leaders of the Close Up Foundation and their gifted
young educators who are charged with conducting the program. To a
person we are impressed by the integrity, commitment, and the passion
they bring to their work.''----Dr. David E. Sawyer, Superintendent,
2003 Tulsa Public Schools, Tulsa, Oklahoma.
``Close Up gave me the insider's view of Washington and our
government. I now have a greater understanding of the political
process. I learned that I can make a difference, and I now have a
greater desire to participate in the political system. . . . Close Up
gave me a passion and interest in the United States government.''----
Katherine McDermott, Student, 2004 Doniphan-Trumbull High School,
Doniphan, Nebraska.
``Close Up is a huge part of my life. I met amazing people from all
over the country and each one of those people helped me to fully
establish and solidify my political views. Because of my involvement in
Close Up I have been able to help educate my peers about how our
government works as well as work for educating people about voting.''--
--Andrea Nowak, Student 2004 Bishop Foley High School, Madison Heights,
Michigan.
``I always had strong political views, but being surrounded by kids
who `didn't care' about current events, I never had to prove my ideas
to anyone. Going on Close Up, I realized that not everyone shared my
views, in fact, some even said I was wrong! . . . While I didn't back
down, I at least began to understand the other side's argument,
something I would never have been able to do before. . . . Close Up
opened me up to a whole new world of ideas, thought, and way of life.
And while I may not agree, at least I can agree to disagree.''----Emily
Wolfe, Student, 2004 Newton South High School, Newton Centre,
Massachusetts.
``The Close Up Program, in particular our time on Capital Hill,
affords students the opportunity to experience democracy in a hands-on
fashion, thus making it real to them. In addition, it validates the
necessity of their role in a democratic society.''----Lori Merkel,
Teacher, 2003 East Valley High School, Spokane, Washington.
``This organization provides a unique experience for both students
and teachers. I am a history teacher at Senn High School in Chicago.
Like many Chicago Public Schools, we battle the effects of poverty
every day in our classrooms. The opportunity the Close Up Foundation
gives to these students is tremendous. This may be the only time in the
lives of my students where they will have this type of access to
Washington, DC and the officials who make decisions affecting their
lives.''----Johanna Klinsky, Teacher, 2004 Nicholas Senn High School,
Chicago, Illinois.
``. . . You . . . may not hear about the lives that are changed
through your work each day, but please know that your support and
leadership make dreams come true for students and create life-changing
experiences. It may sound cliche, but it is so very true: Only in
America can children who are born in the most humble of circumstances
have real opportunities to make all of their dreams come true. Truly,
the broad scope of American education positively impacts every student
and extends to each student a special invitation to excellence.''----
Dr. Beverly Boone, Principal, 2003 The Anchor School, Biscoe, North
Carolina.
______
Prepared Statement of Zero to Three
Chairman and Members of the Subcommittee: I am pleased to submit
the following testimony on the Labor/Health and Human Services/
Education and Related Agencies fiscal year 2005 Appropriations on
behalf of ZERO TO THREE. My name is Matthew Melmed. For the last 9
years I have been the Executive Director of ZERO TO THREE. ZERO TO
THREE is a national non-profit organization that has worked to advance
the healthy development of America's babies and toddlers for over 25
years. I would like to start by thanking the Subcommittee for all of
their work to ensure that our nation's at-risk infants and toddlers
have access to early intervention and positive early learning
experiences.
We know from the science of early childhood development that
infancy and toddlerhood are times of intense intellectual
engagement.\1\ During this time--a remarkable 36 months--the brain
undergoes its most dramatic development, and children acquire the
ability to think, speak, learn, and reason. All babies and toddlers
need positive early learning experiences to foster their intellectual,
social, and emotional development and to lay the foundation for later
school success. Babies and toddlers living in high-risk environments
need additional supports to promote their healthy growth and
development. Disparities in children's cognitive and social abilities
become evident well before they enter Head Start or Pre-Kindergarten
programs at age 4. I am here to talk to you today about why it is
important to increase funding for three programs focused on the unique
needs of low-income infants and toddlers--Early Head Start, the Child
Care and Development Fund (CCDF) and Part C of the Individuals with
Disabilities Education Act (IDEA).
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\1\ Shonkoff J., and Phillips, D. (Eds.) (2000). National Research
Council and Institute of Medicine. From Neurons to Neighborhoods: The
Science of Early Childhood Development. Washington, DC: National
Academy Press.
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EARLY HEAD START
What is Early Head Start?
Congress created Early Head Start in 1995 with strong bipartisan
support. It is the only federal program specifically designed to
improve the early education experiences of low-income babies and
toddlers. The mission of Early Head Start is clear: to support healthy
prenatal outcomes and enhance intellectual, social and emotional
development of infants and toddlers to promote later success in school
and life. Research demonstrates that Early Head Start is effective. The
Congressionally mandated National Evaluation of Early Head Start--a
rigorous, large-scale, random-assignment evaluation--concluded that
Early Head Start is making a positive difference in areas associated
with children's success in school, family self-sufficiency, and
parental support of child development. Early Head Start serves over
63,000 low-income families with infants and toddlers through 708
community-based programs.\2\ Unfortunately, only 3 percent of all
eligible children and families are served.\3\
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\2\ U.S. Department of Health and Human Services, Administration
for Children and Families (2002). Early Head Start Information Folder,
www.headstartinfo.org/infocenter/ehs_tkit3.htm. 2002 EHS Fact Sheet
www.acf.hhs.gov/programs/hsb/research/factsheets/02/hsfs.htm.
\3\ 2002 EHS Fact Sheet www.acf.hhs.gov/programs/hsb/research/
factsheets/02/hsfs.htm. CPS Annual Demographic Survey, March Supplement
2001 Table 23 ``Single Years of Age--Poverty Status of People in 2001''
http://ferret.bls.census.gov/macro/032002/pov/new23_004.html.
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Is Early Head Start Effective?
Key to Early Head Start's success is its emphasis on the
implementation of the Head Start Program Performance Standards, which
ensure the highest quality care for babies and families and its
comprehensive approach to serving children and families. What is most
compelling about the Early Head Start data is that they reflect a broad
set of indicators, all of which show positive impact--patterns of
impacts varied in meaningful ways for different subgroups of families.
For example, the National Evaluation found that Early Head Start
produced statistically significant, positive impacts on standardized
measures of children's cognitive and language development; \4\ The
Evaluation also found that Early Head Start parents were more involved
and provided more support for learning; and that the program helped
parents move toward self-sufficiency.
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\4\ U.S. Department of Health and Human Services, Administration
for Children and Families (2002). Making a Difference in the Lives of
Infants and Toddlers and Their Families: The Impacts of Early Head
Start. Washington, DC.
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Funding
Currently, 10 percent of the overall Head Start budget is used to
serve 63,000 low-income families with infants and toddlers through
Early Head Start--only 3 percent of all eligible children. An increase
in the overall Head Start appropriation is needed and will enable more
eligible infants and toddlers to be served through the 10 percent Early
Head Start set-aside. Congressional authorizers are currently
considering an increase in the Early Head Start funding allocation--
potentially doubling the allocation of funds for infants and toddlers
enrolled in the program. Given the uncertainty of action on that
legislation, we encourage the Subcommittee to increase the Early Head
Start portion of the program to 12 percent of the total appropriation
for Head Start in fiscal year 2005. Additional funds will enable us to
protect and continue to build on the firm foundation that currently
exists and to ensure that more eligible babies and families are able to
benefit from the services of Early Head Start.
THE CHILD CARE AND DEVELOPMENT FUND (CCDF)
What is CCDF?
The Personal Responsibility and Work Opportunity Reconciliation Act
of 1996 revamped the structure of federal funding for child care and
created the Child Care and Development Fund (CCDF). This streamlined
block grant attempts to maximize states' flexibility in administering
child care programs and establishes a single set of rules and
regulations that apply to all components of the fund. CCDF funding is
divided into three streams of federal funds: federal mandatory funds
that do not require a state match; federal mandatory funds that do
require a state match; and federal discretionary funds that do not
require a state match. States are required to spend a minimum of 4
percent of CCDF funds on activities designed to improve the quality of
child care. Today Congress earmarks $100 million of the CCDF funds for
strategies to increase the supply and improve the quality of child care
for infants and toddlers.
Is CCDF Effective?
CCDF provides funds to help improve the quality and supply of child
care for low-income children and families. For example, the infant-
toddler set-aside of CCDF, currently earmarked through the
appropriations process, has helped states focus on the unique needs of
infants and toddlers by investing in specialized infant-toddler
provider training, providing technical assistance to programs and
practitioners, and linking compensation with training and demonstrated
competence. Another example is the quality set-aside of CCDF. The
quality set-aside, currently 4 percent, provides funds to states in
order to support and develop innovative strategies for improving the
quality of child care. Strategies may include: training grants and
loans to providers; improved monitoring; resource and referral
counseling for parents to find child care; and other services related
to improving the quality of child care.
Funding
Despite modest increases in federal child care funding, CCDF funds
are insufficient to serve all eligible children. In fact, the Center
for Law and Social Policy (CLASP) estimates that states served only
about 14 percent of federally-eligible children (approximately 1 out of
7) in fiscal year 2000. Connecticut has an estimated 17,000 children on
its waiting list for child care assistance and has not served any new
low-income working families not receiving welfare since August 2002. A
substantial increase is needed to ensure that all states are able to
serve more eligible children and families. Although states have made
great progress in improving the quality of child care for low-income
children, additional resources are necessary to ensure that more low-
income children have access to quality child care. We must
significantly increase the percentage of the quality set-aside (from 4
to 10 percent) to improve the quality of child care. Finally, because
the infant-toddler set-aside is earmarked through the appropriations
process, we must ensure that the set-aside continues to grow as the
overall funding for CCDF continues to grow.
PART C OF IDEA
What is Part C of IDEA?
Part C of the Individuals with Disabilities Education Act (IDEA)
authorizes the federal support for early intervention programs for
babies and toddlers with disabilities, and provides federal assistance
for states to maintain and implement statewide systems of services for
eligible children, age birth through 2 years, and their families. Under
Part C, all participating states and jurisdictions must provide early
intervention services to any child below age 3 who is experiencing
developmental delays or has a diagnosed physical or mental condition
that has a high probability of resulting in a developmental delay. In
addition, states may choose to provide services for babies and toddlers
who are ``at-risk'' for serious developmental problems, defined as
circumstances (including biological or environmental conditions or
both) that will seriously affect the child's development unless
interventions are provided. The Part C system offers the opportunity to
maximize the impact of Part B dollars (which provides for the education
of children with disabilities ages 3-21). Early intervention services
under Part C may prevent or minimize the need for more costly services
under Part B later in a child's life. Research shows that intervention
is more effective if begun before age 3.
Is Part C Effective?
The Office of Special Education Programs (OSEP) has commissioned
the National Early Intervention Longitudinal Study (NEILS) to examine
what happens to infants and toddlers with special needs and their
families during and after Part C early intervention. NEILS is following
a nationally representative sample of 3,338 infants and toddlers who
received early intervention services. The sample consists of children
from four age groups--the oldest children in the study exited early
intervention in 1998, the youngest children in the study exited early
intervention in 2001. For all age groups, the children were found to be
advancing developmentally and showing greater mastery of milestones
than they had when they entered early intervention.\5\ For the children
who entered early intervention between 6 and 12 months and between 12
and 18 months of age, a significant percentage had mastered many of the
motor and self-help milestones by 1 year.\6\ Children in these two age
groups also showed progress with communication and cognition
milestones.\7\
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\5\ U.S. Department of Education. (2002). Twenty-Fourth Annual
Report to Congress on the Implementation of the Individuals with
Disabilities Education Act, Washington, DC: U.S. Department of
Education.
\6\ Ibid.
\7\ Ibid.
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Funding
In spite of reports from states that referrals to Part C continue
to increase, Part C has received only very small increases over the
past few years. The fiscal year 2003 Part C appropriation was
$434,159,000 while the current fiscal year 2004 appropriation for Part
C is $444,363,000.\8\ Although estimates of children with disabilities
under age 3 range from 3 percent to 5.2 percent,\9\ as of December 1,
2002, only 2.24 percent of all infants and toddlers (267,923) were
served under Part C. Because the federal government is not paying its
fair share to support the provisions of IDEA, the burden is placed on
states and on families. And there is wide variation in the percentage
of infants and toddlers enrolled in Part C across states. For example,
Massachusetts serves 5.8 percent of infants and toddlers while Nevada
serves less than 1 percent.\10\ Substantial increases in the Part C
appropriation are needed to ensure that all eligible infants and
toddlers are served without having the burden placed on states and
families.
---------------------------------------------------------------------------
\8\ Council for Exceptional Children, ``Full Funding for IDEA: It's
a Guarantee, Not Just a Promise.'' February, 2004. Arlington, VA:
Council for Exceptional Children.
\9\ Oser, C., & Cohen, J. (2003). America's babies: The ZERO TO
THREE Policy Center data book. Washington, DC. ZERO TO THREE Press.
\10\ IDEAdata.com (2004). ``Number and Percentage (Based on 2002
population estimates) of Infants and Toddlers Receiving Early
Intervention Services.'' Retrieved April 22, 2004, from
www.IDEAdata.org
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CONCLUSION
During the first 3 years of life, children rapidly develop
foundational capabilities--cognitive, social and emotional--on which
subsequent development builds. These years are even more important for
at-risk infants and toddlers. Early Head Start, the Child Care and
Development Fund, and Part C of IDEA can serve as protective buffers
against the multiple adverse influences that may hinder their
development in all domains.
With the Subcommittee's help, we have made some gains over the past
few years in increasing funding for early intervention and positive
early learning experiences for at-risk infants and toddlers. The fact
remains, however, that our overall policy and funding emphasis is still
to wait until children are already behind developmentally before
significant investments are made to address their needs. I urge the
Subcommittee to change this pattern and invest in infants and toddlers
early on, when that investment can have the biggest payoff--preventing
problems or delays that become more costly to address as the children
grow older. We do not need to accept that vulnerable children will
inevitably have already fallen behind at age four and then provide
special education and intensive prekindergarten services to help them
play catch up. We know how to provide early intervention and positive
early learning experiences to infants and toddlers that works. I hope
the Subcommittee will make that initial investment to prevent very
young children from falling behind.
Thank you for your time and for your commitment to our nation's
infants, toddlers and families.
______
Prepared Statement of the United Tribes Technical College
SUMMARY OF REQUEST
For 35 years United Tribes Technical College (UTTC) has been
providing postsecondary vocational education, job training and family
services to Indian students from throughout the nation. Our request for
fiscal year 2005 funding for tribally controlled postsecondary
vocational institutions as authorized under Section 117 of the Carl
Perkins Vocational and Applied Technology Act is:
--$8 million under Section 117 of the Perkins Act, which is $800,000
over the fiscal year 2004 enacted level. This funding is
essential to our survival, as we receive no state-appropriated
vocational education monies.
--Ensure that the provision that has been included since fiscal year
2002 in the Labor-HHS Education Appropriations Acts that waived
the regulatory requirement that we utilize a restricted
indirect cost rate is continued.
--Funding for renovation of our facilities, many of which are
original to the Fort Abraham Lincoln army installation. A
recent study commissioned by the Department of Education shows
a facility need for UTTC of $49 million.
Restricted Indirect Cost Issue.--Beginning in fiscal year 2002 the
Labor-HHS-Education Appropriations Act provided that notwithstanding
any law or regulation, that Section 117 Perkins grantees are not
required to utilize a restricted indirect cost rate. We thank you for
taking this action, and ask that it be continued in the fiscal year
2005 Act.
In 2001, the Department of Education, for the first time, directed
Indian grantees (both Section 116 and 117 grantees) to apply a
``restricted indirect cost rate'' to their grants. This means each
tribal grantee must obtain another indirect cost rate--exclusively for
its Perkins Act grant--from its cognizant federal agency (which in most
cases is the Inspector General for the Department of the Interior.)
The Department gave two reasons for applying a restricted rate to
these Perkins Act Indian programs: (1) The 1998 Amendments to the
Perkins Act (Sec. 311(a)) prohibits the use of Perkins Act grant funds
to supplant non-federal funds expended for vocational/technical
programs. This ``supplement, not supplant'' limitation previously
applied to State grants, only; and (2) A long-standing Department of
Education regulation (promulgated years before the 1998 Perkins
Amendments) automatically applies the restricted indirect cost rate
requirement to any Department of Education grant program with a
``supplement, not supplant'' provision.
UTTC has no quarrel with the bases and objectives of the
``supplement, not supplant'' rule and seeks no change to this statutory
provision. The primary targets of this rule are States and possibly
local government entities that run vocational education programs with
State or local funds.
By contrast, however, UTTC has little or no ability to violate this
rule, as we have no source of non-federal funds to operate vocational
education programs. Unlike States, we have no tax base and no source of
non-federal funds to maintain a vocational education program. We depend
on federal funding for our vocational/technical education program
operations. Despite our inability to violate the supplanting
prohibition, we are, nonetheless, being disadvantaged by a Department
of Education regulation intended to enforce the prohibition against
States who do have the ability to supplant.
--Impact of new requirement on grantees.--Under DoEd regulations, a
``restricted indirect cost rate'' makes unallowable certain
indirect costs that are considered allowable by other federal
programs. Primarily, these are costs that DoEd believes the
grantee would otherwise incur if it did not receive a Perkins
grant, such as the cost of the grantee's chief officer and
heads of departments who report to the CEO, as well as the
costs of maintaining offices for these personnel.
Prohibiting the Perkins grant from contributing its appropriate
share to the grantee's indirect cost pool will most likely mean that
other federal programs operated by the grantee would be expected to
pick up a great share of the indirect cost pool. This outcome may well
result in objections from the other program agencies that do not want
to bear costs properly attributable to the Perkins grant.
We are caught between conflicting federal agency requirements and
will find ourselves unable to recover the necessary share of indirect
costs attributable to each of the federal programs we operate.
UTTC Excels.--We bring to your attention the following facts about
UTTC, an institution with:
--An 89 percent retention rate
--A placement rate of 90 percent (job placement and going on to 4-
year intuitions)
--A projected return on federal investment of 11 to 1 (2003 study
comparing the projected earnings generated over a 29-year
period of UTTC Associate of Applied Science graduates with the
cost of educating them.)
--The highest level of accreditation. The North Central Association
of Colleges and Schools has accredited UTTC again in 2001 for
the longest period of time allowable--10 years or until 2011--
and with no stipulations. We are also the only tribal college
accredited to offer on-line associate degrees.
The demand for our services is growing and we are serving more
students.--For the Spring Semester 2004, we enrolled 661 students from
more than 45 tribes and 17 states. The majority of our students are
from the Great Plains states, an area that, according to the 2001 BIA
Labor Force Report, has an Indian reservation jobless rate of 75
percent. UTTC is proud that we have an annual placement rate of 90
percent. We hope to enroll 2000 adult students by 2008.
In addition, as of the Spring Semester 2004, we serve 185 children
in our Theodore Jamerson Elementary school, and 133 children in our
infant-toddler and pre-school programs, bringing the population for
whom we provide direct services to 979.
UTTC course offerings and partnerships with other educational
institutions.--UTTC offers 14 vocational/technical programs and awards
a total of 24 2-year degree and 1-year certificates. We are accredited
by the North Central Association of Colleges and Schools.
We are very excited about the recent additions to our course
offerings, and the particular relevance they hold for Indian
communities. These programs are: (1) Injury Prevention, (2) On-Line
Education, (3) Nutrition and Food Services, (4) Tribal Government
Management, and (5) Tourism.
--Injury Prevention.--Through our Injury Prevention Program we are
addressing the injury death rate among Indians, which is 2.8
times that of the U.S. population We received assistance
through Indian Health Service to establish the only degree
granting Injury Prevention program in the nation. Injuries are
the number one cause of mortality among Native people for ages
1-44 and the third for overall death rates. IHS spends more
than $150 million annually for the treatment of non-fatal
injuries, and treatment of injuries is the largest expenditure
of IHS contract health funds. (IHS fiscal year 2004 Budget
Book).
--On-Line Education.--We are working to bridge the ``digital divide''
by providing web-based education and Interactive Video Network
courses from our North Dakota campus to American Indians
residing at other remote sites and as well as to students on
our campus. We currently have 47 students (15.5 FTE) taking on-
line courses. We are accredited by the North Central
Association of Colleges and Schools to provide on-line
associate degrees. We were invited by North Central to share
our experiences in gaining on-line accreditation at their
March, 2004 meeting in Chicago and did make that presentation.
We have also been invited by New Mexico State University to do
the same.
At this point, nearly half of the students taking on-line courses
are campus-based students. On-line courses provide the scheduling
flexibility students need, especially those students with young
children. Our on-line education is currently provided in the areas of
Early Childhood Education and Injury Prevention We will be asking
approval this year from the North Central Association to offer full
degree on-line programs in the following areas: Health Information
Technology, Nutrition and Food Science, Elementary Education, and also
possibly Criminal Justice. This approval is required in order for us to
offer federal financial aid to the students enrolled in these on-line
courses.
--High Demand exists for computer technicians.--In the first year of
implementation, the Computer Support Technician program is at
maximum student capacity. In order to keep up with student
demand, we will need more classrooms, equipment and
instructors. Our program includes all of the Microsoft Systems
certifications that translate into higher income earning
potential for graduates.
--Nutrition and Food Services.--UTTC will meet the challenge of
fighting diabetes in Indian Country through education. As this
Subcommittee knows, the rate of diabetes is very high in Indian
Country, with some tribal areas experiencing the highest
incidence of diabetes in the world. About half of Indian adults
have diabetes (Diabetes in American Indians and Alaska Natives,
NIH Publication 99-4567, October 1999)
We offer a Nutrition and Food Services Associate of Applied Science
degree in an effort to increase the number of Indians with expertise in
nutrition and dietetics. Currently, there are only a handful of Indian
professionals in the country with training in these areas. Future
improvement plans include offering a Nutrition and Food Services degree
with a strong emphasis on diabetes education and traditional food
preparation.
We also established the United Tribes Diabetes Education Center to
assist local tribal communities and our students and staff in
decreasing the prevalence of diabetes by providing diabetes educational
programs, materials and training. We published and made available
tribal food guides to our on-campus community and to tribes.
--Tribal Government Management/Tourism.--Another of our new programs
is tribal government management designed to help tribal leaders
be more effective administrators. We continue to refine our
curricula for this program.
A newly established education program is tribal tourism management.
UTTC has researched and developed core curricula for the tourism
program and are partnering with three other tribal colleges (Sitting
Bull, Fort Berthold, and Turtle Mountain) in this offering. The
development of the tribal tourism program was well timed to coincide
with the planned activities of the national Lewis and Clark
Bicentennial last year. As you may know, Lewis and Clark and their
party spent one quarter of their journey in North Dakota. UTTC art
students were commissioned by the Thomas Jefferson Foundation to create
historically accurate reproductions of Lewis and Clark-era Indian
objects using traditional methods and natural materials. Our students
had partners in this project including the National Park Services and
the Peabody Museum at Harvard University. The objects made by our
students are now part of a major exhibition in the Great Hall at
Monticello about the Lewis and Clark expedition.
--Job Training and Economic Development.--UTTC is a designated
Minority Business Center serving Montana, South Dakota and
North Dakota. We also administer a Workforce Investment Act
program and an internship program with private employers.
Economic Development Administration funding was made available to
open a ``University Center.'' The Center is used to help create
economic development opportunities in tribal communities. While most
states have such centers, this center is the first-ever tribal center.
Department of Education Study Documents our Facility/Housing
Needs.--The 1998 Vocational Education and Applied Technology Act
required the Department of Education to study the facilities, housing
and training needs of our institution. That report was published in
November 2000 (``Assessment of Training and Housing Needs within
Tribally Controlled Postsecondary Vocational Institutions, November
2000, American Institute of Research''). The report identified the need
for $17 million for the renovation of existing housing and
instructional buildings and $30 million for the construction of housing
and instructional facilities.
We continue to identify housing as our greatest need. We have a
waiting list of students some who wait from 1 to 3 years for
admittance. For the first time in its history, in the 2002-2003 year,
we were forced to find housing off campus for our students. Enrollment
for the 2002-2003 year increased by 31 percent; and in 2003-2004 our
enrollment increased another 20 percent. In order to accommodate the
enrollment increase, UTTC partnered with local renters and the Burleigh
County Housing Authority. Approximately 40 students and their
dependents were housed off campus. The demand for additional housing
also presents challenges for transportation, cafeteria, maintenance,
and other services.
UTTC has now completed a new 86-bed single-student dormitory on
campus. This dormitory is already completely full as are all of our
other dormitories and student housing. To build the dormitory, we
formed an alliance with the U.S. Department of Education, the U.S.
Department of Agriculture, the American Indian College Fund, the
Shakopee-Mdewakanton Sioux Tribe and other sources for funding. Our new
dormitory has at the same time created new challenges such as shortages
in classroom, office and other support facility space. However, more
housing must be built to accommodate those on the waiting list and to
meet expected increased enrollment.
Some of our housing must be renovated to meet local, state, and
federal safety codes. In addition some homes may be condemned which
will mean lower enrollments and fewer opportunities for those seeking a
quality education.
Thank you for your consideration of our request. We cannot survive
without the basic vocational education funds that come through the
Department of Education's Perkins funds. They are essential to the
operation of our campus and essential to the welfare of Indian people
throughout the Great Plains region and beyond.
______
Prepared Statement of the American Indian Higher Education Consortium
Mr. Chairman and Members of the Subcommittee, on behalf of this
nation's 34 Tribal Colleges and Universities (TCUs), which compose the
American Indian Higher Education Consortium (AIHEC), thank you for the
opportunity to share our fiscal year 2005 funding requests for programs
within the U.S. Department of Education, and the U.S. Department of
Health and Human Services--Head Start program.
This statement will cover two areas: (a) background on the tribal
colleges, and (b) justifications for our funding requests.
BACKGROUND ON TRIBAL COLLEGES
The Tribal College Movement began in 1968 with the establishment of
Navajo Community College, now Dine College, in Tsaile, Arizona. Rapid
growth of tribal colleges soon followed, primarily in the Northern
Plains region. In 1972, the first six tribally controlled colleges
established AIHEC to provide a support network for member institutions.
Today, AIHEC represents 34 Tribal Colleges and Universities located in
12 states, which were begun specifically to serve the higher education
needs of American Indian. Annually, these institutions serve
approximately 30,000 full-and part-time students from over 250
federally recognized tribes.
The vast majority of TCUs is accredited by independent, regional
accreditation agencies and like all institutions of higher education,
must undergo stringent performance reviews on a periodic basis to
retain their accreditation status. In addition to college level
programming, TCUs provide much needed high school completion (GED),
basic remediation, job training, college preparatory courses, and adult
education. Tribal colleges fulfill additional roles within their
respective reservation communities functioning as community centers,
libraries, tribal archives, career and business centers, economic
development centers, public-meeting places, and child care centers.
Each TCU is committed to improving the lives of its students through
higher education and to moving American Indians toward self-
sufficiency.
Tribal colleges provide access to higher education for American
Indians and others living in some of this nation's most rural and
economically depressed areas. These institutions, chartered by their
respective tribal governments, were established in response to the
recognition by tribal leaders that local, culturally based institutions
are best suited to help American Indians succeed in higher education.
TCUs combine traditional teachings with conventional postsecondary
courses and curricula. They have developed innovative means to address
the needs of tribal populations and are successful in overcoming
longstanding barriers to higher education for American Indians. Since
the first tribal college was established on the Navajo reservation,
these vital institutions have come to represent the most significant
development in the history of American Indian higher education,
providing access to and promoting achievement among students who may
otherwise never have known postsecondary education success.
Despite their remarkable accomplishments, tribal colleges remain
the most poorly funded institutions of higher education in the country.
Persistently inadequate funding remains the most significant barrier to
their success. Funding for basic institutional operations of 26
reservation based colleges is provided through Title I of the Tribally
Controlled College or University Assistance Act (Public Law 95-471).
Funding under the Act was first appropriated in 1981. Over 20 years
later, the funding level has reached just 70 percent of the authorized
level of $6,000 per full-time Indian student. In fiscal year 2004,
these colleges are receiving $4,230 per full-time equivalent Indian
student toward their institutions operating budgets. While mainstream
institutions have had a foundation of stable state tax-based support,
TCUs must rely on year-to-year federal appropriations for their basic
institutional operating funds. Because TCUs are located on Federal
trust territories, states have no obligation to fund them even for the
non-Indian state-resident students who account for approximately 20
percent of TCU enrollments. Yet, if these same students attended any
other public institution in the state, the state would provide basic
operating funds to the institution.
Inadequate funding has left many of our colleges with no choice but
to operate under severely distressed conditions. Although facilities
initiatives of the last few years have resulted in widespread
construction at TCUs, many colleges began in surplus trailers; cast-off
buildings; and facilities with crumbling foundations, faulty wiring,
and leaking roofs and have a long way to go. Sustaining quality
academic programs is a challenge without a reliable source of
facilities maintenance and construction funding.
As a result of more than 200 years of Federal Indian policy--
including policies of termination, assimilation and relocation--many
reservation residents live in abject poverty comparable to that found
in Third World nations. Through the efforts of tribal colleges,
American Indian communities receive services they need to reestablish
themselves as responsible, productive, and self reliant.
JUSTIFICATIONS
Higher Education Act
The Higher Education Act Amendments of 1998 created a separate
section within Title III, Part A, specifically for the nation's Tribal
Colleges and Universities (Section 316). Titles III and V programs
support institutions that enroll large proportions of financially
disadvantaged students and have low per-student expenditures. TCUs
clearly fit this definition as they are among the most poorly funded
institutions in America, yet they serve some of the most impoverished
areas of the country. TCUs are victims of their own success. This year
two new tribal colleges are eligible to compete for funding under Title
III. Despite the increase in the size of the pool of eligible
institutions, the President's fiscal year 2005 Budget recommends an
increase of $500,000 to this vital program. We urge the Subcommittee
fund section 316 at $26 million, an increase of $2.7 million over
fiscal year 2004 and $2.2 over the President's request, and we ask that
report language included in since fiscal year 2003 be restated
clarifying that funds not needed to support continuation grants or new
planning or implementation grants be available for facilities
renovation and construction grants.
The importance of Pell grants to our students cannot be overstated.
Department of Education figures show that at the majority of all tribal
college students receive Pell grants, primarily because student income
levels are so low and our students have far less access to other
sources of aid than students at mainstream institutions. Within the
Tribal College system, Pell grants are doing exactly what they were
intended to do--they are serving the needs of the lowest income
students by helping people gain access to higher education and become
active, productive members of the workforce. We urge Congress to fund
this critical program at the highest possible level.
Carl D. Perkins Vocational & Applied Technology Education Act
Tribally-Controlled Postsecondary Vocational Institutions.--Section
117 of the Perkins Act provides basic operating funds for two of our
member institutions: United Tribes Technical College in Bismarck, North
Dakota, and Crownpoint Institute of Technology in Crownpoint, New
Mexico. We urge Congress fund this program at $8 million and reiterate
language included since fiscal year 2002 stating that Section 117
Perkins grantees need not utilize restricted indirect cost rate.
The President's fiscal year 2005 budget proposes the elimination of
the Native American Program Section 116, which reserves 1.25 percent of
appropriated funding to support Indian vocational programs. We strongly
urge Congress to continue this program, which is vital to the survival
of vocational education programs being offered at TCUs.
Greater Support of Indian Education Programs Under ESEA
American Indian Adult and Basic Education.--This section supports
adult education programs for American Indians offered by TCUs, state
and local education agencies, Indian tribes, institutions, and
agencies. Despite a lack of funding, TCUs must find a way to continue
to provide basic adult education classes for those Indians that the
present K-12 Indian education system has failed. Before many
individuals can even begin the course work needed to learn a productive
skill, they first must earn a GED or, in some cases, learn to read.
According to a 1995 survey conducted by the Carnegie Foundation for the
Advancement of Teaching, 20 percent of the participating students had
completed a tribal college GED program before beginning higher
education classes at the tribal college. At some schools, the
percentage is even higher. Clearly, the need for basic educational
programs is tremendous, and TCUs need funding to support these crucial
activities. Tribal colleges respectfully request that Congress
appropriate $5 million to meet the ever-increasing demand for basic
adult education services.
American Indian Teacher Corps.--American Indians are severely
under-represented in the teaching and school administrator ranks
nationally. These competitive programs, aimed at producing new American
Indian teachers and school administrators for schools serving American
Indian students, support the recruitment, training, and in-service
professional development programs for Indians to become effective
teachers and school administrators, and in doing so excellent role
models for Indian children. We believe that the TCUs are the ideal
catalysts for these initiatives because of our current work in this
area and the existing articulation agreements TCUs hold with 4-year
degree awarding institutions. We request Congress support these
programs at $10 million and $5 million, respectively, to increase the
number of qualified American Indian teachers and school administrators
in Indian Country.
Department of Health and Human Services/Administration for Child, Youth
and Families/Head Start
Tribal Colleges and Universities (TCU) Head Start Partnership
Program.--The TCU/Head Start partnership has made a lasting investment
in our Indian communities by creating and enhancing associate degree
programs in Early Childhood Development and related fields. New
graduates of these programs can help meet the mandate that 50 percent
of all program teachers earn an associate degree in Early Childhood
Development or a related discipline by 2003. One clear impediment to
the ongoing success of this partnership program is the erratic
availability of discretionary funding made available for the TCU/Head
Start partnership. In fiscal year 1999, the first year of the program,
six TCUs received 3-year awards; in fiscal year 2000, seven additional
colleges received 3-year grant awards; in fiscal year 2001, duration of
grants was extended from 3-years to 5-years but only three additional
TCUs received grants; in fiscal year 2002 no new grants were awarded;
and in fiscal year 2003, eight new grants were awarded. The President's
fiscal year 2005 budget includes a request of $6.9 billion for Head
Start Programs. We request Congress direct the Head Start Bureau to
designate a minimum of $5 million for the TCU/Head Start Partnership
program, to allow current grantees ensure that this critical program
can be continued and be expanded so that all TCUs might participate in
the TCU/Head Start Partnership program.
CONCLUSION
Tribal colleges are bringing education to thousands of American
Indians. The modest Federal investment in the tribal colleges has paid
great dividends in terms of employment, education, and economic
development, and continuation of this investment makes sound moral and
fiscal sense. We very much need help to sustain and grow our programs
and achieve our missions.
Thank you again for this opportunity to present our funding
requests. We respectfully ask the Members of this Subcommittee for
their continued support of TCUs and full consideration of our fiscal
year 2005 appropriations request.
______
Prepared Statement of Florida State University
Mr. Chairman, I would like to thank you and the Members of the
Subcommittee for this opportunity to present testimony before this
Committee. I would like to take a moment to briefly acquaint you with
Florida State University.
Located in Tallahassee, Florida's capitol, FSU is a comprehensive
Research I university with a rapidly growing research base. The
University serves as a center for advanced graduate and professional
studies, exemplary research, and top quality undergraduate programs.
Faculty members at FSU maintain a strong commitment to quality in
teaching, to performance of research and creative activities and have a
strong commitment to public service. Among the current or former
faculty are numerous recipients of national and international honors
including Nobel laureates, Pulitzer Prize winners, and several members
of the National Academy of Sciences. Our scientists and engineers do
excellent research, have strong interdisciplinary interests, and often
work closely with industrial partners in the commercialization of the
results of their research. Florida State University had over $162
million this past year in research awards.
FSU recently initiated a new medical school, the first in the
United States in over two decades. Our emphasis is on training students
to become primary care physicians, with a particular focus on geriatric
medicine--consistent with the demographics of our state.
Florida State University attracts students from every county in
Florida, every state in the nation, and more than 100 foreign
countries. The University is committed to high admission standards that
ensure quality in its student body, which currently includes some 345
National Merit and National Achievement Scholars, as well as students
with superior creative talent. We consistently rank in the top 25 among
U.S. colleges and universities in attracting National Merit Scholars to
our campus.
At Florida State University, we are very proud of our successes as
well as our emerging reputation as one of the nation's top public
research universities.
Mr. Chairman, let me tell you about a project we are pursuing this
year through the U.S. Department of Education.
Florida State University (FSU), with support from the State of
Florida and Governor Jeb Bush, initiated a state-wide partnership among
the state's universities, local schools, teachers, principals, and
other educational leaders to address the highest priority issues in K-
12 education. The partnership, entitled the Multi-University Reading,
Mathematics and Science Initiative (MURMSI), is designed to measurably
improve teaching and learning in Reading, Mathematics and Science in
Florida's K-20 schools with a special emphasis on students considered
``at risk'' due to economic or other conditions. It seeks to develop a
deeper understanding of ways to improve Reading, Mathematics, and
Science education through a strategically planned research agenda and
action plans for change.
Randomized experiments that are highly valued in other fields, such
as health, medicine, economics, psychology, political science--and more
recently Pre-K education--are rare in K-12 education. As a result,
existing research provides little knowledge about the cause and the
effect of interventions and programs. The Education Sciences Reform Act
of 2002 (H.R. 3801) passed by Congress includes language aimed to
strengthen research design and methodology in education, including use
of random assignment, when feasible, particularly in cases where
researchers expect to make claims about causal relationships.
The connection between research and practice is also a weak link in
K-12 education. A number of recent publications have substantiated a
lack of connection between the results of systematic study and
application in the field. Given the current budget outlook for Florida
and the nation as a whole, it is critical that the dollars spent on
education produce improved learning outcomes for students.
Well-designed research and development on priority educational
issues can produce measurable gains in student performance. Critical
knowledge related to improved learning must be produced and, in turn,
applied throughout the state. To be effective, these R&D efforts must
directly connect research, teacher preparation, professional
development, practice and evaluation. To avoid duplication of effort,
they must also be carefully coordinated across various stakeholder
groups, including other universities, policy makers, K-12 leaders and
teachers. By coordinating priorities, each entity can focus on its
areas of expertise to accomplish the research, development, evaluation
and dissemination functions essential to support Florida's K-20 system.
The work of this R&D collaboration--over a period of 5 years--
involves the following:
--Assist Florida leaders and decision makers in developing a
strategically planned research agenda targeting high priority
statewide problems in K-20 Reading, Mathematics and Science
education.
--Initiate, conduct and complete priority research projects (within
each university) clearly responsive to critical statewide and
national education needs using a data based, systems oriented
model.
--Provide decision-makers timely technical advisories and summaries
of findings on issues related to education policy and practice.
--Evaluate the impact of state K-20 initiatives designed to improve
K-12 student performance in Reading, Mathematics and Science
and disseminate the results.
--Design and recommend specific applications of the research findings
and support implementation programs in school districts.
--Provide teacher professional development, especially in Reading,
Mathematics and Science content areas, as teachers need to
broaden and deepen their knowledge in response to changing
educational and/or technological needs.
The first year of this initiative (fiscal year 2003) has been
funded through a $1.5 million grant awarded to the FSU Learning Systems
Institute by the U.S. Department of Education. Those resources were
used to develop the research agenda described above and to initiate
pilot research projects at universities across the state. During 2004,
those pilot projects will continue and others will be added. In 2005,
MURMSI will focus primarily on full implementation of the high priority
research agenda in K-12 Reading, Mathematics and Science education. All
aspects of this work will be done through the collaborative partnership
and consensus-building process with other universities and
stakeholders. Results of the research projects will be systematically
shared with policy makers and educators throughout the state.
We are seeking $3 million in fiscal year 2005 to continue the work
on this important state-wide project.
Mr. Chairman, this is just one of the many exciting activities
going on at Florida State University that will make important
contributions to solving some key concerns our nation faces today. Your
support would be appreciated, and, again, thank you for an opportunity
to present these views for your consideration.
______
Prepared Statement of the NCB Development Corporation
On behalf of NCB Development Corporation, I am pleased to once
again submit written testimony to the U.S. Senate's Committee on
Appropriations Subcommittee on Labor, Health and Human Services, and
Education on the subject of charter school facility finance. I am Terry
D. Simonette, president and chief executive officer of NCB Development
Corporation located in the District of Columbia and I would like to
thank Chairman Specter and Ranking Member Harkin for the opportunity to
submit this written testimony today on fiscal year 2005 funding for
charter school facility finance which addresses the needs of the
underserved and displaced communities under the jurisdiction of the
Subcommittee. At the outset, let me share with you some background
information on the NCB Development Corporation and our approach to
address the charter school facility finance problem. Then I would like
to share our thoughts on why charter schools should be looked at in a
community development strategy.
NCB Development Corporation (NCBDC), an affiliate of National
Cooperative Bank pursuant to the National Consumer Cooperative Bank Act
(Public Law 95-351) is a national nonprofit organization that for 25
years has provided innovative financial and development services to
improve the lives of low-income individuals, families, and communities.
By creatively investing in our neighborhoods, advocating elected
officials around public policy, and collaborating with other national
and local community-based organizations, NCBDC helps charter schools
finance and develop facilities; creates a policy environment that
supports strong, self-sustaining communities; enables community health
centers to expand to serve more patients; preserves and creates
affordable housing; and helps socially responsible businesses thrive.
As you may already know, according to the Center for Education
Reform, there are currently nearly 3,000 charter schools in 42 states
and the District of Columbia giving nearly 750,000 students an
opportunity to receive a quality education. Unlike traditional public
schools, charter schools are not given a public building in which to
operate. Instead, it is up to the charter school to find and fund an
appropriate location. Operators, who are often concerned parents,
teachers, or nonprofit organizations, typically have little experience
with planning, zoning, and building code regulations, let alone finding
affordable space and adequate financing. And very few financing
organizations are willing to lend to charter schools.
Since the mid-1990's, NCBDC has been considered an expert in the
small community of organizations in the forefront of designing and
implementing innovative financing strategies to meet a charter school's
demand for capital. To date, between our lending and technical
assistance programs, NCBDC has assisted 210 charter schools in 19
states obtain the facilities they require to accomplish their missions
impacting 38,106 students, provided more than $66 million in facilities
financing sustaining no monetary defaults and 0 percent loss rates on
charter school lending, and helped leverage more than $100 million in
additional funds. Major partners in these initiatives have included the
U.S. Department of Education, Charter Friends National Network, the
Florida Consortium of Charter Schools and the Midwest Charter
Facilities Coalition.
As a 2001 recipient of a U.S. Department of Education National
Activities Grant in and in partnership with the Charter Friends
National Network established the Technical Assistance Project for
Charter School Facilities to help charter schools develop and finance
suitable buildings by providing on-the-ground technical assistance and
workshops in facility development and financing. In the initial round
of the highly competitive U.S. Department of Education's Charter School
Facilities Financing Demonstration Grant Program, NCBDC partnered with
The Reinvestment Fund, a leading community development financial
institution based in Philadelphia, and Foundations, Inc., a leading
technical assistance provider. In 2002, we were successful in receiving
a $6.4 million grant to create the Charter School Capital Access
Program (CCAP). CCAP successfully met the goal of raising $45 million
from investors including PNC Bank of Pennsylvania to create a capital
pool to help charter schools in the Mid-Atlantic States of New York,
New Jersey, Pennsylvania, Delaware, and Virginia, and in the District
of Columbia acquire, renovate, or construct facilities. This is a
leverage ratio of nearly seven private dollars for every one public
dollar.
In 2003, the U.S. Department of Education again recognized NCBDC's
innovative work in charter school facility finance and awarded NCBDC a
$6 million grant under the Credit Enhancement Program for Charter
School Facilities, which is a valuable tool for motivating the private
sector to get involved in charter school capital development. This
grant will enable NCBDC to enhance facilities loans and educational
opportunities for children in Florida, Georgia, Minnesota, and
Wisconsin. NCBDC was one of four and the only repeat grantee having
been awarded $6.4 million through the Department's initial Charter
Schools Facilities Financing Demonstration Program as previously
referenced.
Because we have seen firsthand the dire need for charter school
facility finance, NCBDC supports the continuation and expansion of the
Credit Enhancement for Charter School Facilities Program by increasing
appropriations levels as authorized by the United States Congress in No
Child Left Behind (NCLB or Public Law 107-110) signed into law on
January 8, 2002.
According to a U.S. General Accounting Office (GAO) report
commissioned by Congressional Requesters (GAO-03-899, September 2003)
states: ``The three greatest challenges facing new charter schools were
securing a facility, obtaining start-up funding and acquiring the
expertise necessary to run a charter school.'' The 2000 National Study
of Charter Schools funded by the Office of Educational Research and
Improvement within the U.S. Department of Education identified two of
the same obstacles as lack of management expertise and inadequate
facilities financing, which pose a formidable obstacle for the vast
majority of start-up and established charter schools. Each of the three
major financing approaches--municipal bonds, per pupil allocations, and
conventional financing--offer only limited opportunities for charter
schools that seek funds to lease, acquire, construct, or renovate a
facility. There is a no more serious challenge facing charter schools
nationally than obtaining upfront and ongoing financing for facilities.
Despite the difficulty in securing credit, charter schools are
remarkably resourceful in addressing their facilities needs, yet are
generally unable to take advantage of the financing that is available
to school districts and typically pay for facilities out of their
regular operating funds. As a result, finding and funding a building
impacts limited operating funds which in turn impacts teachers,
administrative personnel and the purchase of everyday supplies.
Not finding a suitable home has delayed school openings, and forced
schools to scale back their programs or shut down altogether, due to
the inability to find adequate facilities. Charter schools are usually
distinguished by their relatively small size; perceived instability of
revenue streams, short operating track records, and political
uncertainty. These characteristics pose formidable obstacles for the
private sector, which has a low-risk tolerance and is often reluctant
to lend in an ``emerging'' market. Consequently, charter schools also
require new, creative financial models to address their growing demand
for capital.
NCBDC applauds the President and the United States Congress in
their commitment to charter school facility finance including the more
than $37 million proved in the omnibus appropriations bill signed into
law on January 23, 2004 (Public Law 108-199) for the continuation of
the Credit Enhancement for Charter School Facilities Program and the
President's $100 million request in his fiscal year 2005 budget
released in February 2004. The Program will continue to assist charter
schools in acquiring, leasing, and renovating school facilities. This
is done through a competitive grant process to public and non-profit
entities for loan guarantees, debt insurance, and other activities that
facilitate private lending. While the demand for charter school
facility finance is estimated nationally at more than $2 billion, $37
million falls far short of the $200 million in grants authorized yearly
until 2007 in the NCLB, as outlined in the bipartisan Carper-Gregg
Amendment in the act.
With our long history of a strong commitment to community
development, particularly as it relates to underserved urban
populations, NCBDC believes that strong schools are a cornerstone of
any thriving community. Good schools keep families involved in
neighborhoods, and this involvement is essential to community
revitalization. Public charter schools encourage stability by offering
parents a tuition-free choice outside the traditional public school;
charter schools can keep families in communities with under-performing
public schools. In addition, NCBDC has found that in the process of
developing a facility, charter schools can be an effective tool for
urban renewal and neighborhood revitalization. Finally, NCBDC believes
that strong school-community partnerships, which are encouraged by
charter schools, help build neighborhoods.
During this time of rising budget deficits and the rise in the cost
of the war on terrorism, fiscal constraints make efforts to fulfill
Congress' commitment to education, especially charter school facility
finance, far more difficult then it has been in years past. Charter
advocates, including NCBDC, have long been supportive of the efforts by
the Administration and Congress to provide adequate appropriations for
the charter school facilities initiatives set forth in the landmark
bipartisan NCLB. We are hopeful that this Subcommittee, and ultimately
this Congress, will provide appropriate charter school funding at the
authorized levels, as charter schools are continuously faced with the
lack of funding or expertise to purchase, build, or renovate a building
and other physical plant requirements.
NCBDC appreciates this opportunity to reinforce the critical need
served by supporting expanded funding for charter school facility
finance. With your assistance, the charter school community can
continue to make a difference in the lives of this nation's most
vulnerable children, families, and communities. In summary, NCBDC
requests a NCLB authorized fiscal year 2005 appropriation level of $200
million to help charters leverage private financing for facilities and
start-up costs--an increase of $100 million over the President's fiscal
year 2005 budget request and $163 million over the fiscal year 2004
appropriated level. In addition, NCBDC supports the continued expansion
of the Public Charter Schools Program by supporting the President's
fiscal year 2005 request of $219 million to provide grants to states to
support 1,200 new and existing charter schools including $19 million
for the new Charter Schools Per-Pupil Facilities Aid program.
Thank you again for allowing NCBDC to present its concerns
regarding fiscal year 2005 appropriations provision of charter school
facilities financing in written testimony before the Subcommittee.
______
RELATED AGENCIES
Prepared Statement of the National Federation of Community Broadcasters
Thank you for the opportunity to submit testimony to this
Subcommittee regarding the appropriation for the Corporation for Public
Broadcasting (CPB). As the President and CEO of the National Federation
of Community Broadcasters, I speak on behalf of nearly 250 community
radio stations and related organizations across the country. Nearly
half our members are rural stations and half are minority controlled
stations. In addition, our members include many of the new Low Power FM
stations that are putting new local voice on the airwaves. NFCB is the
sole national organization representing this group of stations which
provide service in the smallest communities of this country as well as
the largest metropolitan areas.
In summary, the points we wish to make to this Subcommittee are
that NFCB:
--Requests $410 million CPB for fiscal year 2007, a $10 million
increase over the fiscal year 2006 advance appropriation;
--Requests $60 million in fiscal year 2005 for conversion of public
radio and television to digital broadcasting. Also supports
funding for the Public TV interconnection system;
--Requests that advance funding for CPB is maintained to preserve
journalistic integrity and facilitate planning and local fund
raising by public broadcasters;
--Requests report language to ensure that CPB utilizes digital funds
it receives for radio as well as television needs;
--Supports CPB activities in facilitating programming services to
Latino and Native American radio stations;
--Supports CPB's efforts to help public radio stations utilize new
distribution technologies and requests that the Subcommittee
ensure that these technologies are available to all public
radio services and not just the ones with the greatest
resources.
Community radio fully supports $410 million for the Corporation for
Public Broadcasting in fiscal year 2007.--Federal support distributed
through the CPB is an essential resource for rural stations and for
those stations serving minority communities. These stations provide
critical, life-saving information to their listeners. Yet they are
often in communities with very small populations and limited economic
bases so that the community is unable to financially support the
station without federal funds.
In larger towns and cities, sustaining grants from CPB enable
community radio stations to provide a reliable source of noncommercial
programming about the communities themselves. Local programming is an
increasingly rare commodity in a nation that is dominated by national
program services and concentrated ownership of the media.
For the past 28 years, CPB appropriations have been enacted 2 years
in advance. This insulation has allowed pubic broadcasting to grow into
a respected, independent, national resource that leverages its federal
support with significant local funds. Knowing what funding will be
available in advance has allowed local stations to plan for programming
and community service and to explore additional non-governmental
support to augment the federal funds. Most importantly, the insulation
that forward-funding provides ``go[es] a long way toward eliminating
both the risk of and the appearance of undue interference with and
control of public broadcasting.''----House Report 94-245.
For the last few years, CPB has increased support to rural stations
and committed resources to help public radio take advantage of new
technologies such as the Internet, satellite radio and digital
broadcasting. We commend these activities which we feel provide better
service to the American people, but want to be sure that the smaller
stations with more limited resources are not left out of this
technological transition. We ask that the Subcommittee include language
in the appropriation that will ensure that funds are available to help
the entire public radio system utilize the new technologies,
particularly rural and minority stations.
NFCB commends CPB for the leadership it has shown in supporting and
fostering the programming services to Latino stations and to Native
American stations. Satelite Radio Bilingue provides 24 hours of
programming to stations across the United States and Puerto Rico
addressing issues of particular interest to the Latino population in
Spanish. At the same time, American Indian Radio on Satellite (AIROS)
is distributing programming for the Native American stations, arguably
the fastest growing group of stations. There are now over 30 stations
controlled by and serving Native Americans, primarily on Indian
reservations.
This last year CPB undertook a comprehensive assessment of the
Native American Radio system. It recognized the importance of these
stations in serving local isolated communities (all but one are on
Indian Reservations) and in preserving cultures that are in danger of
being lost. The report recognized that ``. . . very difficult
environments.'' CPB funding is critical to these rural, minority
stations. CPB's funding of the Intertribal Native Radio Summit in 2001
helped to pull these isolated stations together into a system of
stations that can support each other. The report goes on to say
``Nevertheless, the Native Radio system is relatively new, fragile and
still needs help building its capacity at this time in its
development.''
CPB also funded a Summit for Latino Public Radio which took place
this in September 2002 in Rohnert Park, California, home of the first
Latino Public Radio station. These Summits have expanded the circle of
support for Native and Latino Public Radio and identified projects that
will improve efficiency among the stations through collaborations, and
explore new ways of reaching the target audiences.
CPB plays a very important role for the public and community radio
system. They are the convener of discussions on critical issues facing
us as a system. They support research so that we have a better
understanding of how we are serving listeners. And they provide funding
to programming, new ventures, expansion to new listeners, and projects
that improve the efficiency of the system. This is particularly
important at a time when there are so many changes in the radio and
media environment with new distribution technologies and media
consolidation. An example of this support is the grant that NFCB
received to update and publish our Public Radio Legal Handbook online.
This provides easy to read information to stations about complying with
governmental regulations so that stations can function legally and use
their precious resources for programming instead of legal fees.
Finally, community radio supports $50 million in fiscal year 2005
for conversion to digital broadcasting by public radio and
television.--It is critical that this digital funding be in addition to
the on-going operational support that CPB provides. The
Administration's proposal that digital money should be taken from the
fiscal year 2005 CPB appropriation would effectively cut stations'
grants by more than 25 percent. This would have a devastating impact
during these hard economic times when stations are facing major cuts
from state and institutional funds. And it would come at a time when
the local voices of community and public radio are especially important
to notify and support people during emergency situations and to help
communities deal with the loss of loved ones--things that commercial
radio is no longer able to do because of media consolidation.
While public television's digital conversion needs are mandated by
the FCC, public radio is converting to digital to provide more public
service and to keep up with what commercial radio is doing. The Federal
Communications Commission has approved a standard for digital radio
transmission. The initial conversion of radio stations is being
concentrated in 13 seed markets. CPB has provided funding for 42
stations in these markets to convert to digital, is supporting
additional research on AM radio conversion, and is working with radio
transmitter and receiver manufacturers to build in the capacity to
provide a second channel of programming. Most exciting to public radio
is the encouraging results of tests that National Public Radio has
conducted that indicate that stations can broadcast two high quality
signals, even while they continue to provide the analog signal. The
development of 2nd audio channels will potentially double the public
service that public radio can provide, particularly in service to
unserved and underserved communities. This initial funding will only
help a small number of the stations that will ultimately need to
convert to digital or be left behind.
Community Radio also supports funding for the public television
interconnection system.
Federal funds distributed by the CPB should be available to all
public radio stations eligible for Federal equipment support through
the Public Telecommunications Facilities Program (PTFP) of the National
Telecommunications and Information Agency of the Department of
Commerce. In previous years, Federal support for public radio has been
distributed through the PTFP grant program. The PTFP criteria for
funding are exacting, but allow for wider participation among public
stations. Stations eligible for PTFP funding and not for CPB funding
include small-budget, rural and minority controlled stations and the
new Low Power FM service.
We appreciate Congress' direction to CPB that it utilize its
digital conversion fund for both radio and television and ask that you
ensure that the funds are used for both media. Congress stated, with
regard to fiscal year 2000 digital conversion funds:
``The required (digital) conversion will impose enormous costs on
both individual stations and the public broadcasting system as a whole.
Because television and radio infrastructures are closely linked, the
conversion of television to digital will create immediate costs not
only for television, but also for public radio stations (emphasis
added). Therefore, the Committee has included $15,000,000 to assist
radio stations and television stations in the conversion to
digitalization . . .''----(S. Rpt. 105-300)
This is a period of tremendous change. Digital is transforming the
way we do things; new distribution avenues like digital satellite
broadcasting and the Internet are changing how we define the business
we are in; the concentration of ownership in commercial radio makes
public radio in general and community radio in particular, more
important as a local voice than we have ever been. New Low Power FM
stations are providing new local voices in their communities. Community
radio is providing essential local emergency information, programming
about the local impact of the major global events taking place,
culturally appropriate information and entertainment in the language of
the native culture, as well as helping to preserve cultures that are
dying out.
During this time, the role of CPB as a convener of the system
becomes even more important. The funding that it provides will allow
the smaller stations to participate along with the larger stations
which have more resources, as we move into a new era of communications.
Thank you for your consideration of our testimony.
______
Prepared Statement of the American Association of Museums
Chairman Specter, Senator Harkin and distinguished members of the
Subcommittee, the American Association of Museums (AAM) appreciates the
opportunity to testify on the fiscal year 2005 budget for the museum
program at the Institute of Museum and Library Services (IMLS). The
museum program at IMLS is the primary federal entity devoted to
assisting museums in fulfilling their role as centers for lifelong
learning for all Americans. We respectfully request your approval of
the Administration's budget request of $41.4 million for the Office of
Museum Services, which reflects a strong endorsement of the vital
public service role museums play in their communities.
The American Association of Museums, headquartered in Washington
D.C., is the national service organization that represents and
addresses the needs of museums and to enhance their ability to serve
the public. AAM disseminates information on current standards and best
practices and provides professional development for museum
professionals to ensure that museums have the capacity to contribute to
life-long education in its broadest sense and to protect and preserve
our shared cultural heritage. Since its founding in 1906, AAM has grown
to more than 16,000 members across the United States--nearly 10,500
individual museum professionals and volunteers, more than 3,000
museums, and 2,500 corporate members.
In its reauthorization of IMLS last year, Congress reaffirmed its
commitment to the public to ensure that museums will continue to be
centers of lifelong learning and to protect and preserve our nation's
heritage. By appropriating federal dollars for these purposes, you
ensure that society will have museums that are relevant, inspiring and
accessible.
Through its grant awards, IMLS has supported museums that are
responding to the needs of their communities. We are especially excited
about the new Museums for America program, which provides a critical
source of funding that supports museums and their roles in public
service, education and stewardship. With a focus on strategic planning
and institutional mission, it addresses the specific needs of the
museum and its community while helping accomplish IMLS's broader
national goal of creating and sustaining a nation of learners.
We have already seen the results of IMLS investments in our field.
Through the 2003 Learning Opportunities Grants, more than $15 million
was awarded to 169 museums. This included a grant to the State Museum
of Pennsylvania to create a distance learning program that provides
professional development to science teachers in Central Pennsylvania.
As school districts meet the challenges put forward in the No Child
Left Behind Act, museums are stepping forward with their vast
collections, research, and staff expertise to strengthen teachers'
current knowledge and classroom instruction in the method of scientific
inquiry as well as the other disciplines of arts and humanities.
A project in Iowa is another example of museum-school
collaborations. With support from IMLS, the Grout Museum District
provided a weeklong Museum School to 1,000 third grade students from
the Waterloo and Cedar Falls public schools district. Children, their
families and teachers experienced local history. Students applied their
lessons in math, science, and language to real-world situations while
gaining a greater understanding and appreciation for how their
community fits into the larger world.
With grants from IMLS, these museums developed programs that
addressed the specific needs of their communities. These examples,
however, also represent a much larger commitment museums are making to
public education. A recent IMLS survey also shows that museum
expenditures in support of K-12 education now exceed $1 billion
annually. In fact, the percentage of museums' median annual operating
budgets spent on educational programming has increased four-fold just
since 1996. With more than 18 million instructional hours in 2000-01,
museums are offering a broad range of services to schools. They are key
partners in developing curriculum, providing professional development
for teachers, and offering direct services to students through visits
to museums, classroom visits by museum educators, and Web based
educational materials and programs. In some communities, students
attend schools that are actually housed in museums and run by museum
staff.
The commitment of museums to education does not end with their ties
to formal education. Museums are also places of lifelong learning. They
provide an environment rich with opportunity for intergenerational
learning and sharing where children, their parents, and their
grandparents can work together to connect ideas and experiences in
direct, vivid and meaningful ways. Museum visitors can come to know the
struggles and accomplishments of different cultures and unfamiliar
people and achieve a deeper understanding of their own families,
neighborhoods, the country in which they live, and the world.
Museums do not undertake this educational responsibility without an
equal commitment to the care, protection and preservation of our
nation's heritage found in their collections. There are more than 750
million objects and living specimens being held in the public trust by
American museums. This number grows as museums continue to acquire the
material patrimony of our civilization to assure that they remain
publicly available for generations to come. A rough estimate places the
annual expenditure for the care of those public collections at $1.1
billion. The need for conservation is ongoing and these costs will
continue to grow with time as collections expand and age.
IMLS makes significant investments in both direct support for
conservation and assistance to museums with identifying and
prioritizing their conservation needs. In 2003, Conservation Support
grants were awarded to 86 institutions. This program requires a 1:1
match and allows institutions such as the Wentworth-Coolidge Mansion in
Portsmouth, New Hampshire to make much needed repairs to its gutters,
improve drainage on the site, and make other improvements that will
prevent further moisture damage to this national historic landmark and
its unique contents.
Through the Conservation Assessment Program, Idaho's Twin Falls
County Historical Museum, Texas' Sam Houston Memorial Museum, and
Alabama's Magnolia Grove-Hobson Memorial Shrine were able to have a
general conservation survey of their collections, environmental
conditions and sites. Conservation priorities are identified by
professional conservators who spend 2 days on-site and provide a
written report to help museums develop strategies for improved
collections care. Many institutions use the report for long-term
planning and for attracting financial support to meet the conservation
needs identified in the report.
America's museums, by their missions and tax exempt status, exist
for the benefit of the public. The museums in your states and across
the country are responsible for preserving the past, defining the
present and educating for our future. The leadership and support of the
federal government is critical to each of our nation's museums. The
United States has a strong tradition of financial support for the
public service mission of museums through public-private partnerships.
Museums have three major income sources--private charity and foundation
grants, earned and investment income, and government funding. Private
charity represents 36 percent of museums' budgets, earned and
investment income represents 33 percent and 11 percent respectively,
and government funding--local, state, and federal--is 25 percent of
museums' budgets. The largest portion of government funding is from the
local and state level, with only 2.5 percent coming from the federal
government. But it is a critical 2.5 percent.
This diversity of funding sources for museums is critical to their
long term financial stability, but the recent economic uncertainty has
strained all sources of funding for museums. The good news is that
museums are remarkably resilient institutions and are determined to
continue with their full array of public programs. This commitment is
due in part to IMLS awards made through the Museum Assessment Program.
More commonly known as MAP, participating museums can select from a
menu of four assessments and receive a professional review of their
operations in that area. Following the review, museums are given
recommendations and technical assistance which help them identify how
they measure up to best practices in the field and where they might
need improvement. This independent report informs an institution as it
sets priorities and plans to become a better museum. In 2003, 170
grants were awarded to institutions in 42 states, including the East
Ely Railroad Depot Museum in Nevada, Kent Plantation House in
Alexandria, LA, and the Fort Worth Botanic Garden in Texas.
Museums must remain responsive to the needs of their communities.
The public is concerned about education and our economy. Our
institutions are seeking additional new ways to collaborate with the
schools and teachers to instill in every child a passion for learning.
We are working with local officials to make our communities vibrant and
attractive to businesses and tourists. Our nation's museum directors
and staff are deeply committed to their work and to serving the public.
Every day in our nation's museums, thousands of museum educators greet
school buses of children, historians and scientists research our past,
and registrars catalog and track millions of objects. And museum
directors across the country are always seeking the resources to
sustain their institutions so they can fulfill their educational and
stewardship responsibilities.
I particularly applaud IMLS and the Administration for recognizing
that the needs of our museums are not just for the collections or the
public programs, but also for the ongoing professional development of
the leaders and staff within our museums--directors, curators,
registrars, educators, conservators, and many others. In the fiscal
year 2005 budget, the Administration has requested $1 million for the
professional development of museum personnel. We will need to invest
more, but I believe this to be a good start.
A commitment from the federal government is needed to help museums
and their staff fulfill their public obligations. In partnership with
IMLS we believe we can do just that, and I stress the word partnership.
We fully support the strong U.S. tradition of public-private
partnerships supporting museums' public service mission. We believe
that IMLS is in a unique position with its expertise and flexibility to
help us address these current challenges and to help our museums plan
for the future. What the agency lacks is the financial resources.
IMLS needs sufficient funding to help our museums ensure that
current and future generations have the fullest access to, and
understanding of, our national heritage through the highest quality
exhibitions, education programs and digitized materials for the Web.
Innovation in museums allows them to better serve the public. As I
noted before, we believe the administration's fiscal year 2005 request
for the museum programs at IMLS is an important step towards further
realizing the potential of museum education and community involvement.
We recognize, Mr. Chairman, that you and your colleagues are under
intense pressure to balance the funding needs of the many worthy
programs under your jurisdiction. As you consider that balance, I am
sure you will recall that last fall you and your colleagues strongly
endorsed the mission of IMLS by reauthorizing the agency for another 5
years. That is why we believe $41.4 million for fiscal year 2005 is a
reasonable and fiscally responsible budget that will serve the public's
demand for museums that are relevant, inspiring and accessible.
We appreciate the opportunity to testify before the committee today
and thank you all for your support of our nation's museums and the
museum program at IMLS.
______
Prepared Statement of the Railroad Retirement Board
Mr. Chairman and Members of the Committee: We are pleased to
present the following information to support the Railroad Retirement
Board's (RRB) fiscal year 2005 budget request.
The RRB administers comprehensive retirement/survivor and
unemployment/sickness insurance benefit programs for railroad workers
and their families under the Railroad Retirement and Railroad
Unemployment Insurance Acts. The RRB also has administrative
responsibilities under the Social Security Act for certain benefit
payments and Medicare coverage for railroad workers. During fiscal year
2003, the RRB paid $8.9 billion in retirement/survivor benefits to
about 666,000 beneficiaries, and $94.1 million in unemployment/sickness
insurance benefits to about 37,000 claimants.
As we explain in greater detail below, the RRB's budget request for
fiscal year 2005 is comprised of two parts, $110.66 million for day-to-
day administrative expenses, plus $4,947,800 for information technology
infrastructure improvements. This request is intended to meet immediate
and significant needs of the agency in two principal areas: (1)
additional staffing, not only to manage current workloads, but even
more importantly, to begin the process of recruiting and training to
meet the RRB's staffing needs going forward; and, (2) modernization and
improvement of our information technology infrastructure to ensure that
the RRB's automated systems will continue to function effectively and
efficiently in the future. These are pressing needs that must be
addressed. However, at the President's proposed budget level of $102.6
million, not only would these critical, longer-term needs not be
funded, but the RRB's ability to continue to deliver quality and timely
service in the short term would also be severely jeopardized.
REQUEST FOR ADMINISTRATIVE FUNDING IN FISCAL YEAR 2005
The RRB has demonstrated fiscal responsibility over the years by
requesting only what was needed to administer the programs under the
Railroad Retirement and Railroad Unemployment Insurance Acts for which
we are responsible. Even though our request is $13 million over the
President's proposed budget, it represents our considered opinion which
will enable us to continue our successful stewardship of the
entitlement programs for our constituents. In considering this
additional funding, we believe it is appropriate to look at the
financial position of the benefit programs we administer in their
entirety. Specifically, we would like to point to the successful
implementation of the Railroad Retirement and Survivors' Improvement
Act of 2001. Under that Act, we transferred a net $20.39 billion to the
National Railroad Retirement Investment Trust (NRRIT) from its
inception in February 2002 through September 30, 2003. The funds held
by the NRRIT grew to $23 billion during that period, reflecting a 19.9
percent return on investments in fiscal year 2003, a market value gain
of $2.7 billion. By comparison, our requested increase in
administrative funding represents less than one-half of 1 percent of
that increase.
A funding level of $110.66 million for ongoing operations would
allow the RRB to maintain our current high levels of timeliness and
accuracy in claims processing operations and to provide the quality
service our customers expect. Our requested appropriation would provide
sufficient funding for 1,046 FTE's--the same number we plan to use in
fiscal year 2004. The additional funding would prevent a costly and
disruptive reduction-in-force and allow us to hire some new employees
for essential positions.
The efficient and timely administration of our Acts requires well-
trained and experienced staff. Although the RRB has already suffered
significant workforce reductions over the last few years, we have been
able to maintain and even improve customer service. This has been
accomplished using a core of experienced staff and productivity gains
through technology. Our immediate concern today is the aging of our
workforce. The bulk of the additional funding in fiscal year 2005, is
to mitigate the expected loss of experienced staff by hiring and
training new employees and to increase available resources for advances
in information technology.
This funding level would also allow us to provide resources for
important administrative needs, including travel, training and overtime
to support our service to the public. We would also be able to
reinstate employee benefit programs, including transit benefit
subsidies, which have been suspended due to insufficient funding. At
our request level, an additional $300,000 would also be available for
information technology. We would use this money to replace aging
desktop computing equipment and software.
ENTERPRISE ARCHITECTURE CAPITAL ASSET PLAN
Our budget request includes funding the first year of our
Enterprise Architecture Capital Asset Plan for fiscal years 2005-2007,
which addresses the major initiatives needed to implement our target
enterprise architecture. This request is highlighted separately because
of its significance to the long-term continued viability of agency
programs, and the realization that movement toward the desired target
architecture will be a multi-year effort. We are requesting an
additional $4,947,800 to begin these initiatives in fiscal year 2005.
Gartner Consulting has recommended that we investigate alternatives
for our Computer Associates' Integrated Database Management System
(IDMS) and be prepared to actively retire the platform beyond 2006. The
Enterprise Architecture Capital Asset Plan includes funding for
contractual assistance, tools and training to begin this transition as
well as related initiatives. Funding has been requested in four key
areas:
--Infrastructure modernization initiative ($1,445,000).--A variety of
improvements to the agency's infrastructure are required to
support our target enterprise architecture. This initiative
provides agency-wide support at the desktop, systems and
network levels. Components include improvements to our data
center infrastructure, client/server software and information
security.
--Modernization blueprint initiative ($1,992,800).--The primary
feature of this initiative is the conversion of the RRB's
database from IDMS to a relational database management system.
The agency's day-to-day operations are heavily dependent on
application systems that are based on IDMS technology. Delaying
this transition in fiscal year 2005 would create a high risk
that the loss of these systems could compromise the RRB's
ability to pay benefits and fulfill its mission in the future.
--Metadata repository initiative ($555,000).--This project funds the
development of a preliminary metadata repository, which is a
critical success factor for implementation of inter-
governmental and internal data sharing services. The metadata
repository will enable us to integrate data from various
sources and mediums, including railroad employers and
employees, annuitants and beneficiaries, State agencies, and
other Federal government agencies.
--E-Government service delivery initiative ($955,000).--This project
funds our initiative to expand electronic services to the
public via the RRB Internet website. In addition, this
initiative funds the continued expansion of a system being
developed to meet the requirements of the Government Paperwork
Elimination Act, which will permit private employers to store
and file electronically, with executive agencies, forms
containing information pertaining to employees. We will expand
services to railroad employers by providing for on-line
completion or transmission of all employer paper forms.
PRESIDENT'S PROPOSED FISCAL YEAR 2005 BUDGET
The President's proposed budget includes $102.6 million for RRB
administrative expenses in fiscal year 2005. This total includes $100.5
million for the ongoing costs of current agency operations. In
addition, the President's proposed budget includes $2.1 million to
contract with a non-governmental disbursement agent for payment of
railroad retirement and survivor benefits in accordance with provisions
of the Railroad Retirement and Survivors' Improvement Act of 2001
(Public Law 107-90).
We believe that an appropriation at this level would seriously
undermine the quality and timeliness of services to our customers in
fiscal year 2005. The negative impact would also carry forward to
subsequent years due to staff reductions, administrative cutbacks, and
further postponement of important automation initiatives.
The reductions at the President's proposed level of funding for
fiscal year 2005, would undermine the RRB's ability to process claims
in a timely manner, including those for retirement, survivor and
disability annuities. Delays would also occur in processing subsequent
annuity adjustments, requests for reconsideration and employer reports.
Customer outreach services would be reduced, creating delays in
responding to inquiries and taking applications for benefits.
Customer service would also be affected if we are required to
contract for the use of a non-governmental disbursement agent in fiscal
year 2005. Not only would this action increase the RRB's operating
costs, but our Inspector General and others have questioned whether
certain services provided by the Department of the Treasury, such as
reclamations, would be provided as effectively by a non-governmental
disbursement agent. On March 20, 2003, we submitted a legislative
proposal to permit the Department of the Treasury to continue to make
payments of railroad retirement benefits.
We would need to make extremely deep cuts in funding for
administrative needs throughout the RRB to operate at the President's
proposed level in fiscal year 2005. Because 80 percent of our budget is
used for employees' salaries and benefits, a major staff reduction
would be unavoidable. We estimate that the President's proposed funding
would support only 969 full-time equivalent staff years (FTE's), which
is 77 FTE's less than we now plan to use in fiscal year 2004. To reduce
agency staffing, we would need to impose a year-long hiring freeze,
leaving positions unfilled as vacancies occur through attrition. We
would also need to conduct a reduction-in-force of 39 employees at the
beginning of fiscal year 2005. The RIF would cost an estimated
$473,000.
Information technology (IT) funding would also be severely limited.
At the President's proposed level of funding, the RRB would have only
$1,325,000 for investments under our ongoing IT Capital Plan. Although
e-Government initiatives are essential to maintaining a high level of
public service and improving productivity in coming years, we would
need to severely curtail purchases of desktop computing equipment and
software needed by the agency's staff. In addition, we would have no
funding available for the major projects in our Enterprise Architecture
Capital Asset Plan. This plan includes funding to begin migration of
agency systems from the Integrated Database Management System, which is
nearing obsolescence. Not funding this initiative creates a high risk
that the loss of these systems could compromise the RRB's ability to
pay claims and fulfill our mission in the future.
The proposed budget would also provide insufficient funding for
other administrative needs, many of which have been sharply reduced in
recent years. We have already suspended several of our employee benefit
programs, including transit benefit subsidies and certain award
programs, which had contributed considerably to employee morale in the
past. These programs would continue to be suspended in fiscal year
2005. We would also continue to severely limit funds allocated for
variable expenses, such as overtime, travel, training, supplies and
equipment.
In addition to the requests for administrative expenses, the
Administration's budget includes $108 million to fund the continuing
phase-out of vested dual benefits, and $150,000 for interest related to
uncashed railroad retirement checks.
FINANCIAL STATUS OF THE TRUST FUNDS
Railroad Retirement Accounts.--As a result of $18.9 billion in net
transfers to the National Railroad Retirement Investment Trust, the net
position of the railroad retirement accounts decreased by $18.1 billion
in fiscal year 2003, to $551.1 million.
In June 2003, we released the 22nd Actuarial Valuation, including
the annual report on the railroad retirement system required by Section
22 of the Railroad Retirement Act of 1974, and Section 502 of the
Railroad Retirement Solvency Act of 1983. The actuarial valuation
contains generally favorable information concerning railroad retirement
financing. However, the long-term stability of the system, under its
current financing structure, is still dependent on future employment
levels and investment returns. The valuation included projections of
the status of the retirement trust funds under three employment
assumptions. These indicated cash flow problems only under a
pessimistic employment assumption, and then not until calendar year
2022.
Railroad Unemployment Insurance Accounts.--The equity balance of
the railroad unemployment insurance accounts at the end of fiscal year
2003 was $51.5 million, an increase of $35.8 million from the previous
year. The RRB's latest annual report on the financial status of the
railroad unemployment insurance system, issued in June 2003, was
generally favorable. The report indicated that even as maximum daily
benefit rates rise 44 percent (from $52 to $75) from 2002 to 2013,
experience-based contribution rates are expected to keep the
unemployment insurance system solvent. The small loan made in fiscal
year 2002 was repaid in May 2003, and no new loans are anticipated even
under our most pessimistic assumption. The average employer
contribution rate remains well below the maximum throughout the
projection period, but a 1.5 percent surcharge is now in effect and is
expected for calendar year 2005 and probably 2006. We did not recommend
any financing changes based on this report.
In conclusion, we want to stress the RRB's continuing commitment to
improving our operations and providing quality service to our
beneficiaries. Thank you for your consideration of our administrative
budget request. We will be happy to provide further information in
response to any questions you may have.
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Alexander, Duane, M.D., Director, National Institute of Child
Health and Human Development, National Institutes of Health,
Department of Health and Human Services........................ 107
Prepared statement........................................... 127
Alving, Barbara, M.D., Acting Director, National Heart, Lung, and
Blood Institute, National Institutes of Health, Department of
Health and Human Services...................................... 107
Prepared statement........................................... 188
American:
Academy of:
Family Physicians, prepared statement.................... 295
Physician Assistants, prepared statement................. 311
Association for:
Cancer Research, prepared statement...................... 407
Dental Research, prepared statement...................... 399
Geriatric Psychiatry, prepared statement................. 416
Museums, prepared statement.............................. 451
College of Cardiology, prepared statement.................... 389
Diabetes Association, prepared statement..................... 274
For the Arts, prepared statement............................. 430
Heart Association, prepared statement........................ 331
Indian Higher Education Consortium, prepared statement....... 442
Institute for Stuttering, prepared statement................. 345
Museum of Natural History, prepared statement................ 308
Psychological Society, prepared statement.................... 352
Public:
Power Association, prepared statement.................... 342
Transportation Association, prepared statement........... 338
Society:
For Microbiology, prepared statements..................276, 420
Of Clinical Oncology, prepared statement................. 362
Thoracic Society, prepared statement......................... 357
Association for Professionals in Infection Control and
Epidemiology, prepared statement............................... 270
Association of:
American Universities, prepared statement.................... 366
Farmworker of the Opportunity Programs, prepared statement... 255
Maternal and Child Health Programs, prepared statement....... 318
University Programs in Occupational Health and Safety,
prepared statement......................................... 288
Women's Health, Obstetric and Neonatal Nurses, prepared
statement.................................................. 327
Battey, James F., Jr., M.D., Ph.D., National Institute on
Deafness and Other Communication Disorders, National Institutes
of Health, Department of Health and Human Services............. 107
Prepared statement........................................... 191
Beldon, William R., Deputy Assistant Secretary for Budget,
National Institutes of Health, Department of Health and Human
Services....................................................... 107
Berg, Jeremy M., Director, National Institute of General Medical
Sciences, National Institutes of Health, Department of Health
and Human Services............................................. 107
Prepared statement........................................... 165
Blue Cross and Blue Shield Association, prepared statement....... 271
California Workforce Investment Board, prepared statement........ 260
Charles R. Drew University of Medicine and Science, prepared
statement...................................................... 386
Close Up Foundation, prepared statement.......................... 433
Coalition of Northeastern Governors, prepared statement.......... 341
Cochran, Senator Thad, U.S. Senator from Mississippi:
Questions submitted by....................................... 70
Opening statements......................................58, 78, 203
Prepared statements.........................................58, 204
Collins, Francis S., M.D., Ph.D., Director, National Human Genome
Research Institute, National Institutes of Health, Department
of Health and Human Services................................... 107
Prepared statement........................................... 143
Community Medical Centers, Fresno, CA, prepared statement........ 308
Cooley's Anemia Foundation, prepared statement................... 395
Digestive Disease National Coalition, prepared statement......... 374
Doris Day Animal League, prepared statement...................... 397
Evans, Samuel London, founder, American Foundation for Negro
Affairs........................................................ 41
Prepared statement........................................... 42
FacioScapuloHumeral Muscular Dystrophy Society, prepared
statement...................................................... 349
Fauci, Anthony S., M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services........................ 107
Prepared statement........................................... 154
First Candle/Sudden Infant Death Syndrome Alliance, prepared
statement...................................................... 377
Florida State University, prepared statement..................... 445
Grady, Patricia A., Ph.D., Director, National Institute of
Nursing Research, National Institutes of Health, Department of
Health and Human Services...................................... 107
Prepared statement........................................... 185
Harkin, Senator Tom, U.S. Senator from Iowa, opening stateme20, 76, 218
Hepatitis Foundation International, prepared statement........... 384
Hodes, Richard J., M.D., National Institute of Aging, National
Institutes of Health, Department of Health and Human Services.. 107
Prepared statement........................................... 147
Hrynkow, Sharon H., Acting Director, Fogarty International
Center, National Institutes of Health, Department of Health and
Human Services................................................. 107
Prepared statement........................................... 133
Hutchison, Senator Kay Bailey, U.S. Senator from Texas, opening
state-
ment........................................................... 16
Illinois Neurofibromatosis, Inc., prepared statement............. 413
Insel, Thomas R., M.D., Director, National Institute of Mental
Health, National Institutes of Health, Department of Health and
Human Services................................................. 107
Prepared statement........................................... 177
International Foundation for Functional Gastrointestinal
Disorders, prepared statement.................................. 381
InterTribal Bison Cooperative, prepared statement................ 279
Jamula, Dr. Melissa, superintendent, Reading School District..... 30
Prepared statement........................................... 32
Jeffrey Modell Foundation, prepared statement.................... 398
Jones, C. Todd, Associate Deputy Secretary for Budget and
Strategic Accountability, Department of Education.............. 1
K-12 Science, Technology, Engineering & Mathematics Education
Coalition, prepared statement.................................. 430
Katz, Stephen I., M.D., Ph.D., Director, National Institute of
Arthritis and Musculoskeletal and Skin Diseases, National
Institutes of Health, Department of Health and Human Services.. 107
Kington, Raynard, M.D., Ph.D., Deputy Director, Office of the
Director, National Institutes of Health, Department of Health
and Human Services............................................. 107
Prepared statement........................................... 180
Kohl, Senator Herb, U.S. Senator from Wisconsin:
Opening statement............................................ 18
Questions submitted by....................................... 244
Landis, Story C., Ph.D., Director, National Institute of
Neurological Disorders and Stroke, National Institutes of
Health, Department of Health and Human Services................ 107
Prepared statement........................................... 168
Landrieu, Senator Mary L., U.S. Senator from Louisiana:
Opening statement............................................ 9
Prepared statements....................................10, 104, 243
Li, Ting-Kai, M.D., Director, National Institute of Alcohol Abuse
and Alcoholism, National Institutes of Health, Department of
Health and Human Services...................................... 108
Prepared statement........................................... 197
Lindberg, Donald A.B., M.D., Director, National Library of
Medicine, National Institutes of Health, Department of Health
and Human Services............................................. 108
Prepared statement........................................... 193
Living Cities: The National Community Development Initiative,
prepared statement............................................. 335
Lymphoma Research Foundation, prepared statement................. 409
March of Dimes Birth Defects Foundation, prepared statement...... 368
Meals On Wheels Association of America, prepared statement....... 343
Medicare Payment Advisory Commission, prepared statement......... 281
Mended Hearts, Inc., prepared statement.......................... 388
Mexican-American Opportunity Foundation and the Career Services
Center, Kern County, CA, prepared statement.................... 271
Murray, Senator Patty, U.S. Senator from Washington:
Opening statement............................................ 11
Prepared statement........................................... 15
Questions submitted by....................................... 71
National:
Alliance for the Mentally Ill, prepared statement............ 314
Area Health Education Centers Organization, prepared
statement.................................................. 301
Association of:
Children's Hospitals, prepared statement................. 305
Home Builders, prepared statement........................ 267
Nutrition and Aging Services Programs, prepared statement 344
State Workforce Agencies, prepared statement............. 260
Coalition for:
Heart and Stroke Research, prepared statement............ 394
Homeless Veterans, prepared statement.................... 264
Osteoporosis and Related Bone Diseases, prepared
statement.............................................. 404
Council on Folic Acid, prepared statement.................... 294
Federation of Community Broadcasters, prepared statement..... 448
League for Nursing, prepared statement....................... 304
Multiple Sclerosis Society, prepared statement............... 364
Primate Research Centers, prepared statement................. 346
Prostate Cancer Coalition, prepared statement................ 427
Sleep Foundation, prepared statement......................... 380
Treasury Employees Union, prepared statement................. 321
Youth Employment Coalition, prepared statement............... 263
NCB Development Corporation, prepared statement.................. 446
NephCure Foundation, prepared statement.......................... 372
Olden, Kenneth, Ph.D., S.C.D., L.H.D., Director, National
Institute of Environmental Health Sciences, National Institutes
of Health, Department of Health and Human Services............. 108
Prepared statement........................................... 174
Oncology Nursing Society, prepared statement..................... 324
Paige, Hon. Roderick, Secretary, Office of the Secretary,
Department of Education........................................ 1
Prepared statement........................................... 4
Summary statement............................................ 2
Pettigrew, Roderic I., Ph.D., M.D., Director, National Institute
of Biomedical Imaging and Bioengineering, National Institutes
of Health, Department of Health and Human Services............. 108
Prepared statement........................................... 137
Railroad Retirement Board, prepared statement.................... 453
Research to Prevention, prepared statement....................... 285
Rotary International, prepared statement......................... 290
Ruffin, John, Ph.D., Director, National Center on Minority Health
and Health Disparities, National Institutes of Health,
Department of Health and Human Services........................ 108
Prepared statement........................................... 120
Rural Opportunities Inc., prepared statement..................... 257
Scanlon, Dr. James, superintendent of schools, Quakertown
Community School District...................................... 34
Prepared statement........................................... 36
Sieving, Paul A., M.D., Ph.D., Director, National Eye Institute,
National Institutes of Health, Department of Health and Human
Services....................................................... 108
Prepared statement........................................... 117
Skelly, Thomas, Director, Budget Services, Department of
Education...................................................... 1
Slobojan, Dr. Marie, director of instruction, Tredyffrin/Easttown
School District................................................ 37
Prepared statement........................................... 39
Society:
For Maternal-Fetal Medicine, prepared statement.............. 401
Of Nuclear Medicine, prepared statement...................... 425
Southern:
California Elderly Nutrition Partnership, prepared statement. 269
Methodist University School of Engineering, prepared
statement.................................................. 429
Specter, Senator Arlen, U.S. Senator from Pennsylvania:
Opening statements.......................................1, 75, 108
Questions submitted by......................................59, 101
Spiegel, Allen M., M.D., Director, National Institute of Diabetes
and Digestive and Kidney Diseases, National Institutes of
Health, Department of Health and Human Services................ 108
Prepared statement........................................... 131
Stevens, Senator Ted, U.S. Senator from Alaska:
Opening statement............................................ 23
Prepared statements.........................................96, 203
Straus, Stephen E., M.D., National Center for Complementary and
Alternative Medicine, National Institutes of Health, Department
of Health and Human Services................................... 108
Prepared statement........................................... 171
Tabak, Lawrence A., D.D.S., Ph.D., National Institute of Dental
and Craniofacial Diseases, National Institutes of Health,
Department of Health and Human Services........................ 108
Prepared statement........................................... 200
The Humane Society of the United States, prepared statement...... 424
Thompson, Hon. Tommy G., Secretary, Office of the Secretary,
Department of Health and Human Services........................ 75
Prepared statement........................................... 81
Summary statement............................................ 79
Tri-Council for Nursing, prepared statement...................... 297
Tucker, C. Delores, founder, Philadelphia Martin Luther King, Jr.
Association for Non-Violent Change............................. 44
Prepared statement........................................... 47
United Tribes Technical College, prepared statement.............. 439
Upper County Branch, Montgomery County, Maryland Stroke Club,
prepared statement............................................. 412
Vaitukaitis, Judith L., M.D., Director, National Center for
Research Resources, National Institutes of Health, Department
of Health and Human Services................................... 108
Prepared statement........................................... 124
Vallas, Paul G., chief executive officer, School District of
Philadelphia................................................... 50
Prepared statement........................................... 52
Volkow, Nora D., M.D., Director, National Institute on Drug
Abuse, National Institutes of Health, Department of Health and
Human Services................................................. 108
Prepared statement........................................... 158
von Eschenbach, Andrew C., M.D., Director, National Cancer
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 108
Prepared statement........................................... 151
Weaver, James, president, Pennsylvania State Education
Association.................................................... 28
Prepared statement........................................... 29
Whitescarver, Jack, Ph.D., Director, Office of AIDS Research,
National Institutes of Health, Department of Health and Human
Services....................................................... 108
Prepared statement........................................... 140
WomenHeart, the National Coalition for Women With Heart Disease,
prepared statement............................................. 411
Zerhouni, Elias A., M.D., Director, National Institutes of
Health, Department of Health and Human Services................ 107
Prepared statement........................................... 112
Summary statement............................................ 110
Zero to Three, prepared statement................................ 436
SUBJECT INDEX
----------
DEPARTMENT OF EDUCATION
Office of the Secretary
Page
Accuracy of Department's Pell Grant Cost Model................... 66
After School and Saturday Programs............................... 46
Aggressive Recruitment of Highly Qualified Teachers.............. 56
Alaska Native Education Equity Act............................... 24
Alaska's Education Challenges.................................... 23
American Foundation for Negro Affairs............................ 48
National Education and Research Fund......................... 49
Arts in Education................................................69, 71
Authorization vs. Appropriation Levels for NCLB.................. 19
Barriers to School Choice........................................ 60
Budget Request and Highly Qualified Teachers..................... 59
Carol M. White Physical Education Program........................ 24
Center for Civic Education's We the People Programs.............. 68
Children Without Homes........................................... 46
Choice and Supplemental Services................................. 61
College:
Enrollment Gap............................................... 65
For Teens Program............................................ 45
Costs of:
No Child Left Behing Act..................................... 35
School Improvement and Choice Requirements................... 60
Education Program Funds That can be Used for Statewide
Longitudinal Student Data Systems.............................. 64
Educational Voucher Programs..................................... 14
Effectiveness of Assessments Being Developed..................... 64
Enhancement of Assessment Projects Focus on Students With
Disabilities and Students With Limited English Proficiency..... 62
Epidemic of Obesity.............................................. 24
Evaluation....................................................... 43
Of AFNA...................................................... 50
Excerpts of the Evaluation (MGL) Process......................... 43
Expanding Comprehensive School Choice Options.................... 54
Federal Support for Foreign Language Instruction................. 71
Fiscal Year 2005 Education Budget Request........................ 3
Flexibility for IDEA and LEP Students............................ 35
Funding for NCLB Programs........................................ 73
Funds for:
Assessments Required by the NCLB Act......................... 62
School Improvement........................................... 60
Grants for Enhanced Assessments.................................. 62
Highlighting Screening Programs in Grant Application Packages.... 27
Historic Levels of Resources and Flexibility..................... 4
Identifying Districts for Screening Programs..................... 27
Implementing a Rigorous Corrective Action Plan for Schools Not
Making Adequate Yearly Progress................................ 55
Increase for Research, Development, and Dissemination............ 68
Increased NCLB Flexibility for Rural and Small Schools........... 24
Increases in the Fiscal Year 2005 Education Budget............... 25
Intensive Supplementary Education Services in Low Performing
Schools........................................................ 55
Internal Revenue Service Data Matching........................... 67
Jobs for the 21st Century........................................ 5
Key Year for No Child Left Behind................................ 3, 4
Leveraging Educational Assistance Partnerships................... 66
Limited English Speaking Students................................ 35
Major Program Increases.......................................... 5
Management Improvements.......................................... 6
Mathematics and Science Partnerships............................. 61
Mid-Session Review Reestimates of Pell Grant Program Costs....... 66
NCLB Act and:
Children With Disabilities...................................39, 52
Limited English Proficient Students.......................... 39
Transferability Provisions................................... 69
New:
Flexibility Under NCLB Requirements.......................... 7
Programs Versus Program Eliminations......................... 67
No Child Left Behind Act..................................2, 28, 34, 51
And IDEA..................................................... 35
And Single Sex Education..................................... 13
Funding Levels............................................... 18
Pell Grant:
Cost Estimates............................................... 66
Maximum...................................................... 65
Pennsylvania Title I Funding..................................... 59
Physical Education and Obesity................................... 24
Public School Choice Funding..................................... 15
Raising Awareness of Existing Programs........................... 26
Rate of State Spending........................................... 21
Reading School District.......................................... 31
Regional Educational Laboratories Program........................ 68
Regulatory Flexibility for Special Education and LEP Assessments. 7
Relationship Between Funding and Achievement..................... 20
Report on:
NCLB Implementation.......................................... 60
Writing by the National Commission on Writing................ 70
School:
Choice and Pell Grants....................................... 72
District of Philadelphia Programming to Implement No Child
Left Behind Legislation.................................... 54
Screening Programs for Teenagers................................. 26
SES Providers.................................................... 57
Single Sex Education..........................................8, 16, 71
And Title IX................................................. 12
Spending Rate by States of Federal Education Funds............... 22
Standards, Curriculum, and Testing............................... 51
Statewide Longitudinal Data Systems.............................. 64
Not Required by NCLB......................................... 64
Steps Taken to Reduce Erroneous Federal Student Aid Education
Payments....................................................... 67
Striving Readers Initiative...................................... 72
Student Participant of College for Teens Program................. 45
Students:
Transferring to Schools not Identified for Improvement Under
No Child Left Behind Act................................... 59
Science Achievement.......................................... 62
``Substantially Equal'' Clause................................... 13
Supplemental Service Providers................................... 61
Teacher Certification............................................ 16
Teen Suicide..................................................... 25
Title I:
Grants to Local Educational Agencies......................... 4
School Choice................................................ 59
Tredyffrin/Easttown School District.............................. 38
21st Century Community Learning Centers.......................... 69
Unspent:
Federal Education Funds...................................... 21
Funds........................................................ 23
Washington Post Op-Ed by Secretary Paige......................... 20
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
A Strategic Approach to Eliminate Health Disparities............. 120
Accelerating Research Discoveries Bench to Bedside: Bedside to
Community NIH Roadmap and Other Initiatives.................... 160
Access to Additional Lines....................................... 224
Actions Underway................................................. 199
Addiction and Obesity: Common Neurobiological Mechanisms......... 158
Additional:
Committee Questions.......................................... 244
Studies on Innovative Therapies for Rheumatic and Skin
Diseases (NIAMS)........................................... 212
Address the Shortage of Advanced Instrumentation Needed to Pursue
Cutting-Edge Biomedical Research (NCRR)........................ 215
Addressing the Obesity Epidemic.................................. 172
Adolescence, the Developing Brain, and Prevention................ 159
Advancing:
The NIH Roadmap: Global Positioning.......................... 136
Tomorrow's Technologies Today................................ 138
Age-related Macular Degeneration (AMD)........................... 239
Alcohol use by Youth............................................. 198
Animal Drug Compounding.......................................... 253
Anorexia and Bulimia (NIMH)...................................... 213
Autism........................................................... 179
Research..................................................... 240
Balancing Large- and Small-Scale Science......................... 167
Basic and Clinical Research Approaches........................... 188
Biodefense Agents................................................ 228
Bioinformatics and Computer Networks............................. 126
Blazing a Trail for the NIH Roadmap.............................. 165
Brain Disorders in the Developing World: Research Across the
Lifespan
(FIC).......................................................... 216
Brain-Communication Interface (NIBIB)............................ 215
Breakthroughs and Advances.....................................110, 112
Budget........................................................... 115
Statement..................................................151, 191
Buildings and Facilities Program................................. 116
Burden of Mental Illness......................................... 177
Cancer Biomedical Informatics Grid (ca BIG)....................152, 206
Cataract......................................................... 118
Changing Microbial Threats....................................... 135
Chemistry of Imaging Agents and Molecular Probes (NIBIB)......... 215
Cholera Reduced by Low Tech Water Filtration..................... 186
Clinical
Research:
Resources................................................ 125
Training (NIDCR)......................................... 207
Trial for the Treatment of Inflammatory Eye Disease (NEI).... 211
Trials....................................................... 170
In Organ Transplantation (NIAID)......................... 209
Network for the Treatment of Age Related Macular
Degeneration (AMD) (NEI)............................... 211
Of HIV/AIDS Vaccine Candidates (NIAID)................... 209
Of Topical Microbicides (NIAID).......................... 209
Closing the Health Disparity Gap................................. 121
Collaborations of Established Clinical Trials Network (CTN) with
Other Established Networks at NIH (NIDA)....................... 213
Combating the Obesity Epidemic................................... 190
Communication Disorders (NIDCD).................................. 213
Comprehensive AIDS Research Plan and Budget...................... 141
Computer-Based Solutions to Biomedical Challenges................ 166
Conduct a Phase III Clinical Trial of Cephalosporin for the
Treatment of ALS (Lou Gehrig's Disease) (NINDS)................ 208
Connection to Obesity............................................ 199
Control of High Blood Pressure in Young Inner-City African-
American Men................................................... 185
Corneal Diseases................................................. 118
Could:
Accelerate Progress Toward Development and Implementation of
Clinical Vocabulary Standards that are Critical to Re-
engineering the Clinical Research Enterprise (NLM)......... 216
Significantly Expand Capability to Analyze, Annotate, and
Classify Massive Amounts of Raw Sequence and Protein Data
to Make It Readily Usable by Researchers (NLM)............. 216
Work with Others to Develop Common Software Platforms for
Advanced Clinical and Educational Applications of the
Visible Human and Other Image Data Sets (NLM).............. 216
Counterfeit Drugs................................................ 253
Cross-Cutting and Cutting-Edge Research.......................... 165
Current Grade Rates.............................................. 248
Cutting Obesity Through Research and Programs.................... 128
Delivering on the Promise of Basic Research...................... 200
Determine Three-Dimensional Structures of Proteins (NIGMS)....... 210
Develop and Support:
A Clinical Trial to Test a Promising Innovative Technique
that could Reduce the Size of Uterine Fibroids (OD--Office
of Research on Women's Health)............................. 217
Women's Health Interdisciplinary Research Centers Especially
in the Areas of: (OD--Office of Research on Women's Health) 217
Develop the Next Generation of International Reseachers (FIC).... 216
Development of:
A Clinical Trials Consortium (NIA)........................... 212
Tools for Investigating Model Organisms (NIGMS).............. 210
Drug Development for Neurological Disorders...................... 169
Emerging Epidemics of Chronic Disease............................ 135
Encouraging Healthy Birth Outcomes............................... 127
Enhance:
Capacity for Disaster/Terrorism Mental Health Research (NIMH) 213
Our Understanding of the Genetic or Heritable Risk Factors
Associated with Drug Abuse Using the CTN as a Valuable
Resource (NIDA)............................................ 213
Opportunities for Women in Science........................... 136
Examining the Safety and Effectiveness of Botanical Products..... 172
Excellent News: Drug use Declines................................ 159
Expand:
Feasibility Trial of Daily Dialysis to Determine Effects of
New, More Intensive Dialysis Modalities on Mortality and
Cardiovascular Disease (NIDDK)............................. 208
Research:
Aimed at Developing Medications for Alcoholism (NIAAA)... 214
On Alcohol Metabolism (NIAAA)............................ 214
On Preventing Drinking by Youth in Rural/Small Urban
Areas (NIAAA).......................................... 214
The Specialized Programs of Translational Research in Acute
Stroke (SPOTRIAS) (NINDS).................................. 209
FDA FOIA Policies................................................ 247
Fiscal Year 2005 Budget:
Request....................................................112, 204
Summary...................................................... 117
Five-Year Randomized Clinical Trial of Chronic Oxygen Use in
Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Patients (NHLBI)............................................... 207
Full-scale Clinical Trial of Primary Interventions to Prevent or
Delay Type 2 Diabetes in Children and Adolescents (NIDDK)...... 208
Funding of Research Grants....................................... 232
Future Cooperative Efforts....................................... 171
Gene:
And:
Environment.............................................. 174
The Nervous System....................................... 168
Replacement Therapy can Generate New Hair Cells.............. 192
Transfer and the Salivary Glands............................. 200
Genomic and Proteomic Resources for Premature Birth (NICHD)...... 210
Getting the Medical Community More Involved in Screening and
Addressing HIV/AIDS and Other Drug Abuse Consequences.......... 161
Glaucoma and Optic Neuropathies.................................. 118
Hair Cell Degeneration and Regeneration in the Inner Ear (NIDCD). 213
Health:
Disparities.................................................. 126
Of Minority, Inner City Newborns Improved by Nurse Home
Visits..................................................... 186
Helping Young Children Prepare for School........................ 129
Highlights of Program Enhancements............................... 131
HIV/AIDS:
Emergency.................................................... 134
Research..................................................... 155
Hydroxyurea Therapy for Sickle Cell Disease...................... 190
Identify and Test Approaches to Reducing Cardiovascular Disease
that are Specific to American Indian and Alaska Native
Populations (NHLBI)............................................ 207
Identifying Genes Important for the Sense of Taste............... 192
Implications..................................................... 200
Implicit Preemption.............................................. 248
Import Inspections............................................... 246
Improve Clinical Trials for Treatment of Inflammatory Bowel
Disease (IBD) (NIDDK).......................................... 208
Improving:
Survival for Victims of Cardiac Arrest....................... 190
Treatment for Critically Ill Children........................ 128
Increase Support for Translational Research--Maximizing the
Results of Basic Research to Improve Public Health (NIAMS)..... 212
Increasing the Number of Nurse Investigators..................... 187
Information Services for the Public.............................. 195
Initiate:
A Definitive Epidemiological Study (NIDCD)................... 213
The Very Large Phase III Clinical Trials for Parkinson's
Disease (NINDS)............................................ 208
Initiative for Pandemic Influenza (NIAID)........................ 209
Initiatives...................................................... 187
Innovative:
Efforts to Combat Health Disparities......................... 120
Methods of Newborn Screening (NICHD)......................... 210
Integrate Technology Developed through the Biomedical Informatics
Research Network (BIRN) into Clinical Research and Other New
Domains Outside of Neuroscience (NCRR)......................... 215
International Research........................................... 143
Intramural Programs.............................................. 170
Introduction of New Institute Directors.......................... 110
Investigating Brain-Body Interactions............................ 173
Launch:
A Trans-NIH Initiative to Learn Whether eHealth Technologies
are Effective in Enhancing Health Behavior Change and
Chronic Disease Management (OD--Office of Behavioral and
Social Sciences Research).................................. 217
Chemical Counterterrorism Research to Combat Nerve Agents
(NINDS).................................................... 208
Loan Repayment and Scholarship Program........................... 185
Looking Forward.................................................. 174
Lung-Volume-Reduction Surgery (LVRS)............................. 189
Medication to Lower Plasma Lipoprotein (a) [Lp(a)]............... 236
Microbicides that can Prevent Sexually Transmitted Infections.... 130
Minimally-Invasive, Image-Guided Surgery (NIBIB)................. 214
More Research Using Brain Imaging Techniques (NIDA).............. 213
Mothers Leaving Welfare had no Effect on Preschoolers............ 130
Mouse Feeder Cell Lines.......................................... 224
Multi-Center Clinical Trial to Evaluate New Treatment Approaches
for Sarcoidosis (NHLBI)........................................ 207
Multidisciplinary:
Imaging Research Partnerships for Addressing Important
Biological or Medical Research Problems of Skeletal Muscle
and Associated Soft Tissue (NIAMS)......................... 212
Research Teams............................................... 140
Muscular Dystrophy and Centers Programs.......................... 170
NARMS............................................................ 252
National:
Advanced Biomedical Technology Initiative.................... 153
Children's Study............................................. 130
NCMHD Could:
Fully Launch its Community-Based Research Program (NCMHD).... 215
Strengthen and Expand its Programs (NCMHD)................... 215
New:
Biomaterials for Tissue Engineering.......................... 139
Challenges in Therapeutics Research.......................... 142
Fragile X Centers to Develop Treatment Options............... 128
Initiatives.................................................. 145
Interventions:
For Prevention and Control of Heart Failure in Persons
Aged 65 and Older (NIA)................................ 212
To Improve Pregnancy Outcomes (NICHD).................... 211
Short Electrode Will Allow Greater Benefit From Cochlear
Implants................................................... 192
Way to Identify Usher Syndrome in Children................... 191
News for Concern: Prescription Drug Abuse Continues.............. 159
NIBIB's Progress................................................. 222
NIDA: 30 Years of Discovery...................................... 158
NIH Roadmap................................113, 120, 139, 181, 193, 202
And Clinical Research........................................ 131
For Medical Research......................................... 111
Obesity.......................................................... 244
And Environment.............................................. 176
Research...................................................221, 235
Ongoing NHGRI Initiatives........................................ 144
Other:
Areas of Interest for NHGRI.................................. 146
International Stem Cell Efforts.............................. 228
Otitis Media (NIDCD)............................................. 213
Pain Research.................................................... 202
Patient Navigation Research Program: Eliminating Barriers to
Timely Delivery of Cancer Diagnosis and Treatment Services
(NCI).......................................................... 206
Periodontal Disease and Preterm Birth............................ 201
Postmenopausal Hormone Therapy................................... 189
Practical Clinical Trials........................................ 179
Practice Based Research Networks of Dental Specialists (NIDCR)... 207
Preparing the Next Generation of U.S. Global Health Leadership... 136
Prevention Trials to Assess the Potential Ability of Non-
steroidal Anti-inflammatory Drugs and a Combination of Anti-
oxidant Vitamins (NIA)......................................... 212
Priority-Setting................................................. 180
Program Initiatives.............................................. 119
Program to Accelerate Therapeutic Development for SMA............ 170
Progress:
In Genetics.................................................. 178
Towards Success.............................................. 137
Projecting Out-Year Budgets...................................... 234
Prospective Studies on Craniofacial Pain & Dysfunction (NIDCR)... 207
Prostate Cancer.................................................. 219
Proteomics....................................................... 127
Pursue the Research Needs and Opportunities Identified at the
Recent NIH Consensus Development Conference on Total Knee
Replacement (NIAMS)............................................ 212
Putting Research Into Practice................................... 202
Refocusing the Research.......................................... 198
Regenerative Dental Medicine (NIDCR)............................. 207
Research:
Activities on Lp(a).......................................... 236
Base to Assess Early Childhood Learning and School Readiness
(NICHD).................................................... 210
In Medical Countermeasures Against Category A Biological
Agents..................................................... 229
Initiative on Pediatric Brain-Behavior Development Vital to
Diagnosing and Treating Child Mental Disorders (NIMH)...... 213
On:
Immune-Mediated Diseases................................. 157
Other Emerging and Emerging Infectious Diseases.......... 156
The Consequences of Marijuana, and the Development of new
Medications............................................ 160
Related to Determining Why Different Individuals Respond
Differently Upon Treatment with the Same Drugs (NIGMS)..... 210
That NIH Could Fund With an Additional $1.3 Billion.......... 205
Restore the Extramural Research Facilities Improvement Program
(RFIP) Funds (NCRR)............................................ 215
Retinal Diseases................................................. 117
Roadmap.......................................................... 179
Robust Program to Evaluate the Toxicology of Nanoscale Materials
(NIEHS)........................................................ 211
Role:
In the Research Mission...................................... 116
Of the National Center for Complementary and Alternative
Medicine................................................... 221
Rural Health..................................................... 124
Safer Drugs for use With Children................................ 130
Schizophrenia Treatment Initiative............................... 178
Science:
Advances..................................................... 196
To Service................................................... 178
Sensors for Medicine............................................. 139
Serving Special Communities...................................... 196
SIDS Research Supports Program Outreach.......................... 129
Spinal Muscular Atrophy...................................237, 238, 240
Stem Cells 168
Lines........................................................ 223
Policy....................................................... 225
Research...................................................217, 226
Stewardship....................................................112, 115
Strabismus, Amblyopia and Visual Processing...................... 119
Strategic Partnerships........................................... 154
Study:
The Role of the Intrauterine and Postnatal Environments in
the Development of Obesity (NIDDK)......................... 208
To Identify Risk Factors for Coronary Heart Disease (CHD) in
Hispanic Populations (NHLBI)............................... 206
Success Rates.................................................... 233
Support Planning Grants to Develop and Optimize Models for
Departments of Clinical Research within Schools of Medicine
(NCRR)......................................................... 215
Team Science and Interdisciplinary Training...................... 167
Technological Innovations........................................ 119
Technology and Instrumentation................................... 125
The:
Future....................................................... 197
Integration of Brain, Behavior and Health.................... 159
Larger Picture............................................... 199
NIAID Research Response to the Threat of Bioterrorism........ 154
NIH Roadmap--Clinical Research............................... 189
NINR Role in the NIH Roadmap................................. 186
National:
Children's Study (NICHD)................................. 210
Institute for Biomedical Imaging and Bioengineering...... 222
Office of:
AIDS Research............................................ 181
Behavioral and Social Sciences Research.................. 182
Disease Prevention....................................... 183
Research on Women's Health............................... 181
Science Education........................................ 184
U.S. Epidemic................................................ 141
Tissue Engineered Human Model Systems (NIBIB).................... 214
Tools for Scientists and Health Professionals.................... 194
Toxicological Evaluation of Nanoscale Materials.................. 176
Trans-NIH Obesity Task Force..................................... 240
Transdisciplinary Research on Energetics And Cancer (TREC) (NCI). 205
Translation Research and Roadmap Efforts......................... 133
Translational Research........................................... 169
Trauma and Injury (FIC).......................................... 215
Trials of Hypertension Control and Prevention.................... 189
2015 Challenge Goal.............................................. 151
2 Percent Decrease in Fiscal Year 2006........................... 235
Understudied Cancers of High Lethality (NCI)..................... 206
Use:
NIMH Clinical Trial Networks to Launch Trials on Simultaneous
Use of Multiple Psychiatric Medications for the Severely
Mentally Ill (NIMH)........................................ 213
Of Metabolomics Technologies for Predicting Toxicological
Responses (NIEHS).......................................... 211
Vaccines and Prevention Research................................. 142
Vocal Fold Paralysis............................................. 193
Women and Minorities............................................. 143
Women's Early Warning Signs of Heart Attack...................... 186
Worldwide Pandemic............................................... 140
Office of the Secretary
Abstinence....................................................... 101
Education.................................................... 100
Access to Recovery............................................... 82
Additional Committee Questions................................... 100
Alaska Dental Association........................................ 95
CDC and NIH Budgets.............................................. 93
Childhood Vaccines............................................... 84
Community and Faith-Based Initiatives............................ 84
Completion of the Doubling of NIH................................ 84
Disease Detection and Bioterrorism Preparedness.................. 83
Drug Reimportation............................................... 91
Expanding Access to Health Care for Americans.................... 82
Fighting HIV/AIDS................................................ 86
Food Labeling.................................................... 97
Global Funds for AIDS, Malaria, and Tuberculosis................. 93
Head Start Program............................................... 85
Health:
Care Information Technology.................................. 86
Professions................................................100, 101
Healthcare Delivery.............................................. 94
Improving the Health, Safety, and Well-Being of Our Nation....... 87
Management Improvements.......................................... 87
Marriage and Healthy Family Development.......................... 86
Mental Health Treatment.......................................... 86
Modernization and Reform Initiatives............................. 87
Money Follows the Person Initiative.............................. 97
Obesity.......................................................... 95
Orasure..........................................................92, 93
Positron Emission Tomography..................................... 95
Prescription Drug Benefit Estimates.............................. 87
Prevention Initiatives........................................... 85
Stem Cell Research..............................................100 102
Vaccines......................................................... 91
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