[Senate Hearing 106-817]
[From the U.S. Government Publishing Office]
S. Hrg. 106-817, Pt. 1 deg.
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2001
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
on
H.R. 4577 and 5656/S. 2553
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, 2001, AND FOR OTHER PURPOSES
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Part 1 (Pages 1-572)
Corporation for Public Broadcasting
Department of Education
Department of Health and Human Services
Department of Labor
Nondepartmental witnesses
Federal Mediation and Conciliation Service
Physician Payment Review Commission
Prospective Payment Assessment Commission
United States Institute of Peace
Nondepartmental witnesses
Social Security Administration
__________
Printed for the use of the Committee on Appropriations
deg.Available via the World Wide Web: http://www.access.gpo.gov/
congress/senate
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For sale by the U.S. Government Printing Office
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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
SLADE GORTON, Washington FRANK R. LAUTENBERG, New Jersey
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
JON KYL, Arizona
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, 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
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY E. CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
JON KYL, Arizona DIANNE FEINSTEIN, California
ROBERT C. BYRD, West Virginia
(Ex officio)
Strip offset folio 0 here deg....................................
Professional Staff
Bettilou Taylor
Mary Dietrich
Jim Sourwine
Aura Dunn
Ellen Murray (Minority)
Administrative Support
Kevin Johnson
Carole Geagley (Minority)
C O N T E N T S
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Tuesday, February 29, 2000
Page
Department of Labor: Office of the Secretary..................... 1
Department of Health and Human Services: Office of the Secretary. 15
Department of Education: Office of the Secretary................. 30
Thursday, March 30, 2000
Department of Health and Human Services: Office of the Secretary. 127
NONDEPARTMENTAL WITNESSES
Department of Health and Human Services.......................... 325
General Healthcare........................................... 325
Centers for Disease Control and Prevention................... 385
National Institutes of Health................................ 400
Department of Education.......................................... 505
Related agencies/general testimony............................... 533
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2001
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TUESDAY, FEBRUARY 29, 2000
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:34 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, Craig, Stevens, Harkin,
Reid, Murray, and Feinstein.
DEPARTMENT OF LABOR
Office of the Secretary
STATEMENT OF ALEXIS M. HERMAN, SECRETARY
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health, Human Services,
and Education will now proceed.
We have an extraordinarily distinguished panel, the three
secretaries of the departments, which are funded by this
subcommittee. Protocol calls for identifying the secretaries in
sequence of appointment.
The Department of Labor goes back to 1913, and the
Department of Health and Human Services to 1953, and the
Department of Education to 1979.
The President has submitted a budget which totals $106.2
billion, which is a very substantial increase over the $95.1
billion from last year. My own view is that in a Federal budget
of $1.8 trillion, that this is a reasonable figure for the
departments which have the responsibilities which these three
departments have.
Now I believe that when you talk about education or health
or worker safety, you are talking about a capital investment in
America. But my views are not widely shared on Capitol Hill.
And there is already talk of a total allocation of a budget far
below the $622 billion, which the President has requested.
It is my hope that we will proceed with the budget process
much faster this year than last year. And I believe that the
leadership in both the House and the Senate agree with that.
We really need to pass these bills and present them to the
President in a timely way, so that they can be acted upon by
the President long before the fiscal year ends and not have
budgets submitted in October and November, bills submitted in
October and November, when there is no opportunity to follow
the constitutional process, which is the Congress submits the
bills, and the President either signs them or vetoes.
We have come to a practice where the Executive Branch sits
in on the legislative process. And it is unconstitutional on
its face, and I think it is highly undesirable. And there are
some significant debates. My own sense is to try to beat the
President's figure illustratively on education. Last year we
came out of the Senate Appropriations Committee with $500
million above the President.
There may be some disagreements on priorities. And the
Congress has a role, perhaps the lead role, on what those
priorities ought to be. But that cannot be debated when you are
into October or November and, if there is a gridlock, the
consequence is closing down the government.
This is a very, very ambitious program. The administration
is moving into a great many areas which have traditionally been
left to the States. Talk about classroom size and more
teachers, talk about school constructions. I supported our
former colleague, Carol Moseley-Braun, Senator Carol Moseley-
Braun, on efforts to begin on the school construction program.
But that is not a widely held view.
And my own sense is that if we make provision for those
kinds of programs, there ought to be some discretion at the
local level, if the local boards decide they want to do
something else, because all of the districts are not the same.
But we cannot have that debate in October and November. But we
could have that debate in July, August or September.
If the President vetoes a bill, let us debate it. Let us
see what we are going to do and how the public responds to a
little difference in the point of view.
This year's budget has a very ambitious program on youth
violence. And I thank the three secretaries and also the
Department of Justice, and specifically Deputy Attorney General
Eric Holder, for working with the subcommittee on a series of
meetings last year, which resulted in the reallocation of some
$893 million on 16 programs to try to focus on juvenile
violence in a quiet, unpublicized way. But the at-risk children
in America are an enormous concern.
I just saw these statistics today that the Senator prepared
from 1992 to the present. There have been 257 school-related
violent deaths, 62 of which involved multiple deaths. I sat
down with Bruce Reed, the domestic counselor, and talked to him
about the coordination program. And I think that really has
great potential.
We are going to take a new look at the drug prevention
program this year, which is a first cousin of youth violence,
and try to take a look to see if we might reallocate some funds
with some specific evidence on the drug issue.
The Foreign Operations Subcommittee last week heard
testimony for $1.6 trillion for money for Colombia. And I am
very much interested in stability in Colombia, but I have grave
doubts about $1.6 trillion going after a supply, which, if it
is not from Colombia, will be from Bolivia or Equador or
somewhere else.
And I believe we have an imbalance with two-thirds of the
money going to the so-called supply side. You have to work on
interdiction. You have to work on street crime. And I spent a
lot of my professional life doing that. But the demand side, I
think, is much more promising, rehabilitation and education, to
deal with that issue.
Well, those are just a brief overview of some of the items
at the top of my mind as to where we are going to be heading.
If we can hold the opening statements--your full statements
will be admitted into the record--to double time, to 10
minutes, that would be great. If you need a little more time, I
have never seen a cabinet officer interrupted yet.
So we will begin with our very distinguished Secretary of
Labor Alexis Herman, if that is the proper name, Ms. Herman.
Ms. Herman was recently married, and she may want to
correct the record, or she may not.
We have just been joined by the illustrious Senator from
Iowa, Senator Tom Harkin. So I will interrupt my introduction
of Secretary Herman to yield to my colleague.
Senator Harkin. Thank you very much, Mr. Chairman. I
apologize for being late. I will just ask that my statement be
made a part of the record.
Senator Specter. And then I will proceed with the
introduction.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. I would welcome the three secretaries here,
in this last budget year of the Clinton administration. I
particularly want to thank all three of the secretaries who are
here for their great leadership.
Secretary Riley and Secretary Shalala for the entire
duration over the last 7 years, your great leadership of your
two departments. And what you have done to move this country
forward both in education, Secretary Riley, and in covering the
health needs of all of our citizens, Secretary Shalala, I
compliment you and commend you for your great leadership over
these several years.
And to Secretary Herman, again for your great work for the
administration in your previous iterations, but also in your
role in this last 4 years with the Department of Labor.
Again, I think the budget that we have, as submitted by the
administration, is one that will continue the progress that we
have made in all these areas to continue to move this country
forward in a way that education gets to the kids that maybe are
not in the highest income areas and have the best schools and
the best education, and gets to middle income families for
college, for sending their kids to college, and the health
needs, the labor area.
PREPARED STATEMENT
I guess I just want to thank you all for what you have done
over the last several years. It has been great working with
you. And I commend you for this last budget of the Clinton
administration, because it does keep us moving in that
direction that you have so stalwartly led over the last several
years, all of you. I just thank you for it and welcome you here
for this hearing.
Senator Specter. Thank you very much, Senator Harkin.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
Mr. Chairman, it's a pleasure to welcome Secretary Herman,
Secretary Shalala and Secretary Riley today to testify about the
Administration's fiscal year 2001 budget.
In general, I was very pleased with the overall fiscal year 2001
budget. I think the President has balanced the need to fund important
domestic programs--many of which are funded in this bill--with the need
to protect Social Security and Medicare.
Secretary Herman, I was very pleased to see the large increase in
funds to eliminate child labor and I look forward to working with you
on that initiative this year. I also want to commend you for your
request to set up an Office of Disability Policy at the Labor
Department. As the chief sponsor of the Americans with Disabilities
Act, I am committed to ensuring that every American with a disability
has the opportunity to achieve economic self-sufficiency and
independence. I am pleased that you share my commitment.
Secretary Shalala, I was glad to see that the Administration has
requested a substantial increase for child care. Last year, during
consideration of this bill on the Senate floor, we were able to
increase funding for the Child Care and Development Block Grant to $2
billion. We lost that increase in the end but I am committed to seeing
that we increase funding for child care to $2 billion in this year's
bill. I am also glad to see the requested $1 billion increase for Head
Start. The evidence is very clear that we need to reach children when
they are very young.
I was somewhat disappointed about the budget request for NIH--an
increase of $1 billion. Last year, this subcommittee was able to
provide a $2.3 billion increase for NIH--maintaining a course to double
NIH funding in five years. This year's request does not keep us on that
course. Senator Specter and I have introduced a Sense-of-the-Senate
calling on the Budget Committee to reflect an $2.7 billion increase for
NIH in this year's budget resolution. The opportunities are out there,
the potential is great. But we have to commit the resources to get the
job done
I must add that I was disappointed in the requested cut in the
Community Services Block Grant and I hope to work with Senator Specter
to restore that cut during this year's appropriation process.
Secretary Riley, I was very glad to see your fiscal year 2001
budget which calls for a $4.5 billion increase for education programs.
And it will come as no surprise to you that I am particularly pleased
with you request of $1.3 billion for school renovations and repairs. As
you well know, the GAO has found that the cost of bringing the Nation's
schools into good repair is about $112 billion. Today, I will be
introducing a bill to reauthorize the existing school infrastructure
program and look forward to working with you on this important
initiative this year.
Thank you, Mr. Chairman--and I look forward to hearing from our
witnesses.
SUMMARY STATEMENT OF HON. ALEXIS M. HERMAN
Senator Specter. One additional note before turning to
Secretary Herman. At a presidential request of $622 billion,
that exceeds the $540 billion cap in the fiscal year 2001
appropriations by some $82 billion. We have not addressed that
yet.
And the caps have not been followed. But that is going to
have to be addressed. According to the President's figures,
that will still leave a $9 billion on-budget surplus. That is
somewhat speculative, but we at least ought to note that it is
not in compliance with the act, and we are going to have to
deal with that as we proceed.
Back to the Secretary of Labor, confirmed in May of 1997,
prior to which she served as assistant to President Clinton and
director of the White House Public Liaison Office. She had
served as deputy director of the Presidential Transition
Office.
During the administration of President Carter, she directed
the Women's Bureau at the Department of Labor, a graduate of
Xavier University.
And again, we congratulate you, Ms. Herman, on your recent
nuptials and look forward to your testimony.
Secretary Herman. Thank you very, very much, Mr. Chairman.
I appreciate your words, also of congratulations. And I am
still known as Secretary Herman and now Mrs. Charles Franklin.
And quite frankly, I see no reason why I have to choose.
I shall be known as both. But thank you very, very much.
Senator Specter. Ms. Herman, you have been chosen, so you
do not have to choose.
Secretary Herman. Mr. Chairman and Senator Harkin, thank
you for the opportunity to present the Department of Labor's
fiscal year 2001 budget. It is a special pleasure for me to
join my colleagues, Secretary Riley and Secretary Shalala, in
outlining the administration's goals and priorities.
Mr. Chairman, I think that we are all aware of the strength
of the American economy today. Yet despite widespread
prosperity, we still face two major and related challenges.
Business leaders tell me that they simply cannot find the
skilled workers that they need. And at the same time, millions
of Americans remain outside the mainstream of our prosperity
for lack of job skills.
Yet, if we take these two problems together, I believe they
constitute an historic opportunity to provide the business
community with the skilled workers it urgently needs, while at
the same time bringing skills, jobs and hope to individuals and
communities that for too long have been left behind.
The President's budget for fiscal year 2001 requests $39.8
billion for our department, $12.4 billion in discretionary
funds. This is an increase of $1.2 billion over last year.
The majority of this increase is for targeted initiatives
to provide the skilled workers who can meet the needs of our
economy. Our budget puts special emphasis on young Americans.
The Department of Labor's new Youth Opportunity Movement is the
most intensive effort to reach young people in our history.
I recently announced youth opportunity grants to address
skills training and job placement in 36 of the poorest urban
and rural areas and Indian reservations in America, places
where the unemployment rate is more than 6 times above the
national average. Our new budget includes $375 million for this
initiative, an increase of $125 million over the current year.
Mr. Chairman, you and I have visited youth programs in
Philadelphia, and we have seen how they change the lives of
young people. I believe our Youth Opportunity Movement will
create similar success stories for tens of thousands of at-risk
youth from coast to coast.
Last September we discussed with this subcommittee ways to
reduce violence and drug abuse among our young people. One of
the administration's responses has been the Safe Schools/
Healthy Students Initiatives started last year by the
Departments of Justice, Education and Health and Human
Services. Our new budget includes $40 million to enable the
Department of Labor to join them in supporting community-wide
programs to prevent youth violence and drug abuse and to
promote youth employment opportunity.
Mr. Chairman, we share your concern that too many out-of-
work young people get into trouble and wind up in jail. We need
to provide positive alternatives and second chances. That is
why our budget builds on the youth offender projects that began
under your leadership and proposes to add $61 million for a
total amount of $75 million.
The youth offender program will bring young offenders into
the workplace through job training and placement and new
partnerships with the criminal justice system. We hope that we
will now be able to work even more closely with the Department
of Justice, which has a companion proposal to bring these young
people back into community life.
Too often, youth unemployment is a part of an environment
that also includes high dropout rates, drug abuse, gang
activity, violence and crime.
Mr. Chairman, in answer to the questions you raised in your
letter about drug abuse reduction and early intervention, we
believe that our youth-related programs can reduce social
problems. Studies show that well-designed school programs lead
to better academic achievement and lower rates of drug abuse,
violence and arrest.
For all of our focus, however, on young people, this cannot
be our only concern. We have to reach out to other untapped
pools of workers. These include 5.7 million unemployed
Americans, 4.4 million who are not in the labor force but say
they want a job, and an additional 3.2 million who work part
time because they cannot find a full-time job.
Our budget includes $255 million for our Fathers Work/
Families Win, a new two-part initiative that grows out of the
successful Welfare-to-Work Program.
Fathers Work will provide jobs for non-custodial parents,
mostly fathers who owe child support. Families Win will help
low-income parents who are struggling to make ends meet by
providing better access to community services and upgrading job
skills.
We are reaching out to people with disabilities, whose
unemployment rates are more than three times the national
average. We took an important step last December, when
President Clinton signed the Bipartisan Work Incentives
Improvement Act, which makes it possible for millions of people
with disabilities to take jobs without losing their health
insurance.
Our budget also includes funds to establish an Office of
Disability Policy, Evaluation and Technical Assistance headed
by an Assistant Secretary, which will provide leadership in
helping disabled Americans enter the workforce.
We are now in the second year of a 5-year effort to provide
skills, counseling and other assistance to every dislocated
worker who loses a job through no fault of their own. To meet
our goal of Universal Re-employment, our budget includes an
increase of $275 million for information, training and One-Stop
Career Centers.
Our concern is not only putting Americans in jobs, but
ensuring that those jobs provide an adequate living for them
and for their families. That is why the President has asked
Congress to increase the minimum wage by $1 over 2 years. And I
strongly endorse his request.
Our budget also includes funds to oppose the worst forms of
child labor around the world and to support international labor
standards. These proposals reflect the President's challenge
for us to put a human face on the global economy and to ensure
that every American worker can compete on a level playing
field, recognizing that today what happens around the globe in
fact impacts workers around the corner.
Mr. Chairman, there will never be a better time than today
to put America to work and to build an even stronger, more
inclusive national economy. We will work with you in every way
that we can to meet these goals.
PREPARED STATEMENT
I appreciate the opportunity to appear before this
subcommittee, and I look forward to answering any questions
that you may have. Thank you very much.
Senator Specter. Thank you very much, Secretary Herman.
[The statement follows:]
Prepared Statement of Alexis M. Herman
Mr. Chairman, and distinguished Members of the Subcommittee, thank
you for the opportunity to appear today to present the Department of
Labor's fiscal year 2001 Budget. I am particularly pleased to join my
colleagues, Secretary Riley and Secretary Shalala, to discuss key
Administration priorities.
Mr. Chairman, I am especially pleased to be here with you today
because the proposals in DOL's fiscal year 2001 budget request are
exciting and innovative and build on seven years of solid
accomplishments.
The President's request for fiscal year 2001 reflects the
Department's goal that all workers have the opportunity to find and
hold jobs, with safe and healthful working conditions, good wages,
secure pensions and health benefits; and that they have opportunities
to improve their skills over their lifetime.
To meet this goal, the overall budget for the Department in fiscal
year 2001 provides a total of $39.8 billion in budget authority. DOL's
request for discretionary programs is $12.4 billion, $1.2 billion above
the fiscal year 2000 level. Since 1993, President Clinton has committed
to investing in today's workers in order to keep America strong in the
years ahead. This budget is faithful to that commitment.
President Clinton, in his State of the Union Message, spoke of the
extraordinary state of our economy the more than 20 million jobs
created over the past 7 years, the lowest unemployment rate in 30
years, and low inflation. America's workers are more productive, and
real wages have increased as well.
The President also recognized that our prosperity is not
universally shared among all Americans. The President called for a 21st
Century revolution of opportunity, responsibility, and community. This
vision includes steps to reward work, strengthen families, and expand
opportunities to all our citizens. DOL has an important role to play in
meeting those challenges.
I believe that the Department's programs are part of those all-
important investments in the workforce and workplace of the future. Our
bottom line is about helping people obtain skills, jobs and
opportunity. It is about ensuring that, as our Nation moves forward, no
one is left behind. We acknowledge that the Government cannot
accomplish this alone; we need to enter into appropriate partnerships
with others who share our commitment for a better America.
HELPING WORKING FAMILIES AT A TIME OF UNPRECEDENTED PROSPERITY
The dynamic forces of technology and globalization, while providing
prosperity for many, continue to change the workplace in ways that may
not benefit some Americans. Those who work hard should be able to
realize the American dream for their families. DOL's budget takes
account of the dramatic changes that are sweeping through the Nation
and the world economy, and proposes significant, realistic policies and
programs to help America's working families manage change and succeed
in this new century.
Today we face two major workforce challenges: one new and one old.
Many businesses report difficulty in filling vacancies. At the same
time, millions of Americans, including many youth, dislocated workers
and people with disabilities, are having a difficult time getting jobs,
even during this period of unprecedented economic expansion. As I have
often said, we do not have a worker shortage, but a skills shortage.
Through the initiatives in the fiscal year 2001 Budget Request, we can
help provide the business community with the skilled workforce it needs
while bringing prosperity to individuals and communities that have been
left behind.
THREE STRATEGIC GOALS
DOL's fiscal year 2001 Budget Request provides the resources we
need to continue to make substantial progress toward DOL's three
strategic goals: a prepared workforce, a secure workforce, and quality
workplaces. I will first briefly describe our three goals and then
describe the initiatives and programs in the fiscal year 2001 Budget
Request that will help us to achieve these goals.
A Prepared Workforce.--DOL's budget request reflects one of the
President's top priorities: investing in education and training to help
ensure that every American has the education and the skills to succeed
in the increasingly competitive global economy. Among other things, we
must help young people make a successful transition to the world of
work and family responsibility. Because a changing economy often
requires our Nation's workers--of all ages--to acquire new skills, we
must also serve dislocated workers in need of assistance as the labor
market changes.
A Secure Workforce.--We must ensure that all Americans are
economically secure both while in the workforce and after they retire.
Employment-based pension and health benefits are the foundation of
family security. Yet only about one-half of all full-time workers in
the private sector have pension coverage today. Three-quarters of the
workers in small businesses are not covered by a pension plan at all.
Increasing access to our private pension system and assuring that
private pensions, health care, and other employee benefits are secure
and properly administered are some of DOL's most critical priorities
addressed in this budget.
Quality Workplaces.--My third goal is to help guarantee every
working American a safe and healthful workplace with equal opportunity
for all. I believe tough enforcement is necessary when an employer's
practices threaten workers' safety and health, discriminate on the
basis of gender, race, religion, color, national origin, veterans'
status, or disability, endanger children, or deprive workers of fair
wages. DOL's ultimate goal, however, is compliance with employment
laws. There must be an appropriate balance of fair and consistent
enforcement, cooperative partnerships, and compliance assistance and
training. Within the context of our global economy, I am also firmly
committed to improving workplaces internationally, such as by improving
implementation of core labor standards internationally and by
eliminating abusive child labor practices abroad.
A PREPARED WORKFORCE
We must ensure that every American has the skills, the education
and the training to be ready for the challenges and opportunities of
the 21st century. The funds in DOL's budget will support programs to
provide skills to young Americans, to work toward the goal of Universal
Reemployment, and to reach out to untapped pools of workers, such as
homeless veterans and Americans with disabilities, and bring them into
the mainstream of our economy.
The fiscal year 2001 Budget Request puts a special focus on helping
young people gain the skills they need to start up the career ladder.
Even in today's booming economy, in some areas, unemployment among
young people reaches 30 percent or more, and that is simply
unacceptable. We cannot afford to lose even one of these young people.
There has never been a better time to invest in workforce development
initiatives. That is why we have launched our Youth Opportunity
Movement to give young people skills, jobs and hope.
Youth opportunity movement
I am proposing several programs under the Youth Opportunity
Movement umbrella to address the opportunity gaps and reach untapped
labor markets in order to advance the goal to promote a prepared
workforce.
I am very pleased that President Clinton helped launch our Youth
Opportunity Movement as part of his New Markets tour last July. This is
the most intensive effort to reach young people in our Department's
history, and it is no secret that it is a personal priority of mine.
Our Labor Day 1999 report entitled ``Future Work: Trends and Challenges
for Work in the 21st Century'' points out that there are almost 11
million young people who are not in school and have a high school
diploma or less. The four million high school dropouts are at a
particular risk of being permanently disconnected and disenfranchised
from our society. There are warning signs when this is about to
happen--the absence of supportive and caring individuals in their
lives; low academic success which often leads to diminished self-esteem
and leaving school; use and abuse of drugs and alcohol; out-of-wedlock
births; and contact with the criminal justice system.
Youth opportunity grants
The Department's fiscal year 2001 budget includes $375 million for
Youth Opportunity Grants, an increase of $125 million above fiscal year
2000. This program is intended to provide comprehensive, longer term
intervention, primarily in the lives of out-of-school youth living in
inner cities and high poverty areas, to help them graduate from high
school, get jobs, and progress in the workforce. On February 19, the
President announced the first round of grants to 36 communities across
the country--from Philadelphia to the Pine Ridge Indian Reservation.
The fiscal year 2001 request includes $250 million to provide for the
third year of funding of these five-year grants. An additional $125
million is requested in fiscal year 2001 to fund the first year of 12
to 15 new competitive grants to high poverty areas. The program will
serve an estimated 85,000 young people next year. These grants will
focus on raising the high school graduation rates and long-term
employment prospects of young people living in these poor areas.
Responsible reintegration for young offenders
As you know, we have shockingly high rates of incarceration in our
Nation today--and many of those in jail are young people. Too many out-
of-work young people get into trouble and wind up in jail, and that is
a tragic waste. We need to provide positive alternatives and second
chances.
That is why our budget includes $75 million to bring young
offenders into the workplace through job training, placement, and
support services, and by creating new partnerships between the criminal
justice system and our workforce development system. When we get young
people out of trouble and into jobs, we are not just helping
individuals, we are strengthening the future of our communities. Each
year, approximately 500,000 people leave prison. We must do more than
lock people in jail. We must lead them into hope for the future.
This initiative will build on our experience with the Youth
Offenders projects begun under your leadership, Mr. Chairman. This
large scale Workforce Investment Act (WIA) Pilot and Demonstration
initiative will link offenders under age 35 with essential services
that can help make the difference in their choices in the future, such
as education, training, job placement, drug counseling, and mentoring,
which are the primary tools for reintegrating this population into the
mainstream economy. Through local competitive grants, this program
would establish partnerships between the criminal justice system and
local workforce investment systems, and will complement a related
program in the Department of Justice. An estimated 19,000 offenders
will be served by this initiative.
Safe schools/healthy students
When we think about the problems young people have today, we also
think of the tragic outbreaks of school violence that have shocked the
Nation. We must ask what we can do to reduce violence and drug abuse,
and help move young people in the right direction.
One of the Administration's responses to this challenge is the Safe
Schools/Healthy Students Initiative, begun in fiscal year 1999 by the
Departments of Justice, Education, and Health and Human Services. DOL's
budget for fiscal year 2001 includes $40 million to enable DOL to join
this partnership in supporting community-wide programs to prevent youth
violence and drug abuse. With DOL's participation, the activities for
the next round of grants can be expanded to provide services to out-of-
school youth, including connections among high schools, post-secondary
schools, alternative schools, and work-based learning programs, in an
effort to reduce violent behaviors.
The White House Council on Youth Violence--of which I am a member--
will play an important role in coordinating both the Safe Schools/
Healthy Students and young offenders initiatives.
Job Corps
The Job Corps continues to be America's biggest and most successful
residential job training program for at-risk youth. The Job Corps
provides intensive skills training and academic and social education
for these youth. I am requesting $1.4 billion for the Job Corps in
fiscal year 2001 to allow us to serve more than 73,000 young people at
122 centers in almost every State. This request includes a net increase
of $35 million above fiscal year 2000 for the Job Corps to support
efforts to attract and retain top-quality staff, and for the operating
costs of new centers.
Universal reemployment
For all our focus on young people, they are not and cannot be our
only concern. Many other Americans need help gaining the skills
demanded by today's economy. Sometimes the challenge is not first-time
employment but reemployment for those who have lost jobs and need new
skills. Two years ago the President set an ambitious goal for our
Nation called ``Universal Reemployment.'' We are on the path to meet
the goal of providing assistance to all dislocated workers who lose a
job through no fault of their own. The initiative will: provide all
dislocated workers who want and need assistance the resources to train
for or find new jobs; expand and improve the quality of employment
services now available to all job seekers and enhance services for
individuals receiving unemployment compensation; and ensure access to
the One Stop System, either in person or electronically, to help
workers find jobs and training.
The Department's fiscal year 2001 request includes $1.975 billion,
an increase of $275 million above fiscal year 2000, for Universal
Reemployment. Of this amount, $1.8 billion, an increase of $181
million, will support dislocated worker retraining and adjustment
assistance activities under Workforce Investment Act. This initiative
will provide State formula grants, as well as a national emergency
grant account, to help 984,000 laid off workers return to work quickly.
These resources are part of a phased in effort to assist all dislocated
workers in need of these services.
We are requesting $154 million for new and better ways of providing
employment and related information through One Stop Career Centers and
America's Labor Market Information System (ALMIS)--an increase of $44
million above fiscal year 2000. ALMIS services include America's Job
Bank which now lists about 1.5 million jobs, and America's Talent Bank,
which lists more than 500,000 resumes. Also included in DOL's request
for the Universal Reemployment initiative is an additional $50 million
for the One Stop Employment Service for reemployment services grants
that will provide targeted, staff-assisted services to unemployment
insurance claimants identified as having a high probability of
exhausting their benefits. This will speed their reentry into
employment and reduce benefit duration. Finally, the request includes
$10 million to implement AgNet nationally, a system that will match
agricultural workers with employers.
We are also concerned about the skill levels of currently employed
workers. DOL's budget proposes $30 million for a new program of
employment and training assistance to incumbent workers under WIA Pilot
and Demonstration authority. This effort is intended primarily to
address the major job losses in the manufacturing industry where one
half million jobs have been lost since March, 1998. Complementing the
activities under the Universal Reemployment proposal, this initiative
will boost skills and wages of non-management U.S. workers through
competitive grants to States to train and upgrade the skills of about
20,000 incumbent workers and, through local partnerships, to help firms
with training in order to prevent displacements.
Fathers work/families win
The Department's budget includes $255 million for Fathers Work/
Families Win, a new two-part initiative that builds on the Welfare-to-
Work program. Fathers Work/Families Win promotes responsible fatherhood
and supports working families.
We have all heard about deadbeat dads. Well, Fathers Work is about
upbeat dads. It will provide jobs for noncustodial parents--mostly
fathers--who owe child support. Most of these fathers are young and
unemployed. Most want to meet their obligations, and Fathers Work will
help make that possible. You cannot pay child support if you do not
have a job.
A complementary part of this initiative, Families Win, will help
low-income parents who are struggling to make ends meet by helping them
find work, obtain better access to community services and upgrade their
skills so they can move up career ladders. Together, these two
initiatives are an important, exciting new way to put America to work.
The strong working relationship we have forged with the Department of
Health and Human Services in administering the job training, Welfare-
to-Work, and Temporary Assistance to Needy Families programs will serve
our Fathers Work/Families Win initiative. For example, our grants will
go only to entities that have established relationships with child
support enforcement agencies, reinforcing linkages that have been
developed under Welfare-to-Work.
These competitive grants will be awarded to State and local
Workforce Investment Boards, enabling States and local communities to
complement welfare reform efforts by focusing on work connections,
post-employment work support activities, and skills training. The
initiative helps families with incomes up to 200 percent of the poverty
level.
Disability initiatives
We are also reaching out to another untapped pool of talent. Last
December, the President signed the bipartisan Work Incentives
Improvement Act, which makes it possible for millions of people with
disabilities to take jobs without losing their health care. At a time
when our economy is booming, 26 percent of persons with a severe
disability are working, as compared to over 80 percent of those persons
without a disability. We cannot afford to waste the talents of millions
of Americans.
DOL's budget includes funds to establish an Office of Disability
Policy, Evaluation, and Technical Assistance headed by an Assistant
Secretary. This new office will provide leadership within the
Department of Labor in helping people with disabilities enter, re-
enter, and remain in the workforce. With the recent passage of the Work
Incentives Improvement Act and the Workforce Investment Act, the stage
is set to achieve real change in the unemployment rate of people with
disabilities. In addition, DOL's budget continues the competitive
grants enacted in fiscal year 2000, totaling $20 million to be awarded
each year by the Department to partnerships of organizations to provide
incentives for broader systems--building on efforts to coordinate
service delivery through, and linkages across, the One Stop Career
Center system established by the Workforce Investment Act.
HOMELESS VETERANS PROGRAMS
Homeless veterans represent another group with untapped promise.
The Department's request for fiscal year 2001 includes $15 million--a
50 percent increase over the fiscal year 2000 level--to provide
employment and training services to help about 15,000 homeless veterans
obtain employment and progress toward self-sufficiency. We expect about
8,700 homeless veterans to find jobs as a result of the services we
provide.
Economic indicators
The Department is also requesting $20 million for the Bureau of
Labor Statistics, $12 million of which is for new initiatives to
improve major economic indicators, which are critical for monitoring
the state of the economy and implementing Federal legislation. In its
Producer Price Index program, BLS will extend coverage for the first
time to the construction sector of the U.S. economy, and will continue
its ongoing expansion of coverage in the service sector. This budget
request includes $4.3 million to develop a new timeuse survey that will
provide nationally representative estimates of how Americans spend
their time in an average week, weekday, and weekend. This will provide
important and meaningful data in many areas such as the amount of time
invested in the care of the young and the elderly in our society,
variations between single and two-parent families, and time invested in
skills acquisition.
A SECURE WORKFORCE
The second strategic goal is a secure workforce. It is not enough
simply to have a job. The goal of a secure workforce helps attain
important values, such as dignity, family and community. A job should
pay a decent wage, should provide health care benefits and should lead
to a quality retirement.
You cannot have security, or strong families and strong
communities, if people work hard and still cannot pay their bills. That
is why the President has proposed to increase the minimum wage by one
dollar an hour over the next two years. This increase would help more
than ten million workers--almost 70 percent of them adults and 60
percent of them women. For a minimum wage worker, a $2000 raise is
enough for a family of four to pay its rent for five months or to buy
groceries for seven months. Raising the minimum wage is simple economic
justice.
Too many workers are also insecure because they are afraid their
jobs will be sent overseas. That is why the President again proposes
legislation to consolidate, reform and extend the Trade Adjustment
Assistance and NAFTA Transitional Adjustment Assistance programs for
workers who lose their jobs due to trade. The proposals would expand
eligibility for benefits to workers who lose jobs when production
shifts abroad, increase training opportunities for trade-affected
workers, link training and income support, and provide needed support
services.
Pension, health and other employee benefits are vital to the
economic security of hard-working Americans and their families. As
Secretary of Labor, I have the responsibility for protecting these job-
based benefits for more than 150 million Americans.
We work diligently to make sure workers feel secure in their
promised benefits. We make certain that the assets held by pension and
health plans are secure and available to pay promised benefits. The
Department operates a nationwide program of educational outreach and
technical assistance that serves to protect the rights of workers and
their families entitled to benefits under their job-based benefit
plans. We provide broad-based outreach to employers, especially small
employers, to assist them with their questions about the plans they
sponsor for their employees and to encourage those employers who do not
sponsor a plan to consider setting one up. The Department also
recognizes the importance of partnerships--we work with the employee
benefits community to find innovative solutions that enhance our
nation's system of employee benefits.
That is why our budget request of $108 million for the Pension and
Welfare Benefits Administration includes additional resources to expand
our efforts to provide protection to the health care and pensions of
workers and their families. These new protections will include
implementing a new program (the Rapid ERISA Action Compliance Team) to
better protect the rights and benefits of American workers and their
families if their employer faces financial hardship and their pension
and health benefits are in jeopardy. In addition, the budget request
will expand the Department's Health Benefits Education Campaign and
enhance our customer service efforts by developing new publications,
multimedia educational products and the creation of a toll-free
interactive system to provide individuals with maximum direct access to
the customer service staff trained to answer their health care and
pension related questions. These initiatives will build on our ongoing
efforts and allow us to respond to the increasing demand from workers
and their families for assistance--last year we responded to over
153,000 inquiries from workers and their families and obtained benefit
recoveries of over 62 million dollars.
The Pension Benefit Guaranty Corporation (PBGC) also helps achieve
the goal of a secure workforce by guaranteeing pension benefits for 42
million workers and retirees in private-sector defined benefit plans.
The budget request provides increases for enhanced computer security
and to speed final benefit determinations.
QUALITY WORKPLACES
Our third strategic goal is quality workplaces. By quality
workplaces, we mean those that reflect such basic values as health,
safety and fair play. Globalization means we must be concerned about
the quality of workplaces overseas as well as at home. That is why the
President has challenged us to put a human face on the global economy.
International child labor
According to the International Labor Organization, an estimated 250
million children between the ages of 5 and 14 are working in developing
countries, 120 million of them full time, and tens of millions under
abusive or dangerous conditions. We are committed to improving the
lives of children both at home and abroad by opposing abusive child
labor wherever it exists and by providing the necessary resources for
its elimination. Building on our past funding of the ILO's
international child labor program, and the recent ILO convention on
banning the worst forms of child labor that was unanimously approved by
the U. S. Senate in November and signed by the President in December,
the Administration proposes $100 million to support international
efforts to eliminate abusive child labor. These funds would not only
permit us to increase the global efforts to remove children from
abusive and dangerous conditions, but would also allow us to increase
our efforts to support the educational infrastructure in areas where
oppressive child labor is a pervasive and systemic problem. Education,
not hard labor provides children with real opportunities and hope for a
better future. I would like to thank Senator Harkin for his impressive
leadership on this issue over the past several years.
International labor standards
Additionally, our budget includes $40 million for international
core labor standards initiatives. The Department proposes to expand the
efforts begun last year to achieve internationally-recognized core
labor standards, and to build social safety nets, so American workers
can be more confident that we are building a global economy with the
``human face'' that President Clinton has called for. This should be a
race to the top--not to the bottom. In all these ways, we are working
to make globalization empower workers and improve their lives, not
accept a lowering of standards at a time when so much progress is
possible.
When we consider quality in the international workplace, we must
also consider the terrible harm being done by HIV/AIDS. When I was in
Africa last year, I saw that AIDS is not only a vast human tragedy but
a major economic disaster. When workers die, their skills and
experience die with them. Production is down in many countries. This
disease threatens not only development and progress in Africa but peace
and stability.
That is why our budget includes $10 million as part of a larger,
government-wide Global HIV/AIDS Initiative that will work with African
leaders to use the workplace as a forum for providing health education
programs to prevent the spread of AIDS. The workplace has a great,
potential for providing millions of workers with information that can
literally save their lives.
Domestic child labor
To continue our commitment towards reducing the more than 200,000
workplace injuries that occur among young workers in America each year,
I am requesting $13 million for the Department's domestic child labor
activities, including $8 million to continue to help eliminate
violations of domestic child labor laws, particularly in the
agricultural sector, and $5 million for demonstration programs to
provide alternatives to field work for migrant youth. This request
includes additional funds to implement targeted enforcement tools,
including ``strike teams'' in the agricultural and garment industries,
and to enhance education and outreach efforts undertaken as part of the
``Safe Work/Safe Kids'' initiative.
Family leave
Today, the Family and Medical Leave Act (FMLA) allows covered and
eligible workers to take up to 12 weeks of job-protected, unpaid leave
to care for a newborn or adopted child, attend to their own serious
health needs, or care for a seriously ill parent, child, or spouse
making it less likely that employees will have to choose between work
and family. The President has again proposed to expand the FMLA to
reach workers in firms with 25 or more employees, extending coverage to
12 million more workers.
For lack of money and other reasons many workers are unable to take
advantage of unpaid leave. The Department is requesting $20 million to
fund competitive planning grants for States and other interested
entities to explore ways to make parental leave and other forms of
family leave more affordable and accessible for American workers. This
initiative will help identify in more detail the workers in need of
financial assistance to take parental/family leave and to develop and
evaluate options to aid these workers.
Equal pay
We cannot talk seriously about a quality workplace unless we also
talk of equal pay for equal work. Today, the average woman who works
full-time earns approximately 75 cents for each dollar that an average
man earns. This gap, in part, is attributable to differing levels of
experience, education and skills. However, even after accounting for
these factors, a significant pay gap remains between men and women.
When women are not fairly paid, their whole family suffers. We need to
rid ourselves of this stubborn, lingering pay discrimination.
That is why the President has proposed an Equal Pay Initiative to
expand opportunities for women and help end wage discrimination. His
proposal includes $17 million for the Department to support initiatives
on behalf of equal pay. The Equal Pay Initiative dedicates $10 million
from the current H-1B nonimmigrant fee for DOL to train women in
nontraditional occupations such as those in high-tech industries and
also provides $7 million to help employers assess and improve their pay
policies, to provide nontraditional apprenticeships, and to support
public education efforts. The President supports the Paycheck Fairness
Act, which would strengthen wage discrimination laws and provide for
additional research, training, and public education efforts on this
important subject.
Workplace safety
Finally, safety and health are absolutely basic to a quality
workplace. We are proud that for the sixth consecutive year, workplace
injury rates have come down and are now at the lowest level since we
began keeping records in the 1970s. But we can still do better. Even
one workplace death is too many.
Our budget includes $668 million to promote health and safety for
more than one hundred million workers through programs of the
Occupational Safety and Health Administration and the Mine Safety and
Health Administration. Through a combination of targeted enforcement,
compliance assistance and partnerships, these agencies work hard to
protect workers from illness, injury and needless death.
The Department's request includes a $44 million increase for OSHA
which will enable OSHA to achieve better balance between its outreach
activities, such as compliance assistance and training, and its
enforcement activities, which in recent years have been targeted to
high hazard worksites. The increase will improve our ability to provide
expertise and services to both employers and employees.
Among OSHA's efforts to provide safe and healthful workplaces is
its ergonomics rulemaking. Workers suffer roughly 600,000
musculoskeletal disorders each year. The proposed standard can protect
27 million workers from the risk of incurring such injuries and
illnesses. I remain committed to completing the standard this year.
The Department is requesting an increase of $14.2 million for the
Mine Safety and Health Administration's (MSHA's) programs to enhance
protection of miners, by providing necessary training to miners and for
better auditing of accident and injury reporting. Approximately $3.2
million of this increase will augment MSHA's enforcement activities in
the metal/nonmetal industries. DOL's budget also includes a request for
additional funds for the State grant program to provide training
assistance to miners and mine operators.
Information technology initiative
The Department's fiscal year 2001 budget establishes a permanent,
centralized IT investment fund for DOL managed by the Chief Information
Officer (CIO). In the past, DOL agencies have separately budgeted for
and managed their own IT investments. While the investments met the
immediate needs of the individual agency, a unified approach will
provide more efficient and effective services.
For fiscal year 2001, the Department's request includes $60 million
to fund IT investments within three crosscutting areas: (1) Information
Technology Architecture and Web Services; (2) Common Office Automation
Implementation; and (3) Security-Critical Infrastructure Protection.
These investments will enable the Department to implement a sound
information technology investment strategy, and expand our Internet
capacity for the elaws program which provides the public with
additional access to information on labor laws.
CONCLUSION
These are some of the ways we will work in fiscal year 2001 to
achieve our Department's strategic goals. These are important, exciting
initiatives, because they are not just numbers or words on paper--they
are about helping real people, with real talents to develop and real
challenges to overcome.
I will be happy to answer to any questions you may have about the
fiscal year 2001 President's Budget for the Department of Labor.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF HON. DONNA SHALALA, SECRETARY
Senator Specter. We now turn to the distinguished Secretary
of Health and Human Services. As noted by Senator Harkin,
Secretary Shalala has served during the full 7 years plus of
the President's administration. And beyond that is the longest
serving Secretary of Health and Human Services in U.S. history.
During her career, she has been a scholar, a teacher, a
public administrator, chancellor at the University of
Wisconsin-Madison, where she was the first woman to head a big
ten university, and named by Business Week as one of the five
best managers in higher education. She earned a Ph.D. from the
Maxwell School of Citizenship in public affairs.
And we welcome you back, Madame Secretary.
Secretary Shalala. Thank you very much, Senator Specter,
Senator Harkin, members of the subcommittee.
I would like to begin by thanking you, Mr. Chairman, for
the leadership you have shown in working to prevent youth
violence. And I would like to thank Senator Harkin for his kind
words, too.
When we presented our fiscal year 2001 budget, I noted the
searing images that we saw last year at Columbine and other
schools must never be repeated. If there was ever a bipartisan
issue in this country, this is it. That is why the President
worked with Congress to establish a new White House Council on
Youth Violence to get all Federal agencies thinking and working
together to prevent youth violence.
And that is why my colleagues, Secretary Herman and
Secretary Riley, and I join you in your determination to bring
to bear the resources we need to fight this problem
effectively. How pleased I am to be with both of them today.
At HHS, the Surgeon General is developing a report on youth
violence that we expect to be completed this year. However,
this much we already know. Violence is preventable. So we
intend to find out what works and what does not and then
publish and disseminate a source book of the best practices.
Our budget also increases the mental health block grant by $60
million, a full 17 percent. And we are budgeting another $78
million to stop youth violence.
Now let me highlight other important features of our budget
and why we believe this budget is critical to the health and
future of the American people.
Our fiscal year 2001 budget brings us to where we should be
at the dawn of a new century, a great nation pledging
allegiance to great goals. Those goals are expanded health care
coverage, renewed support for children and families, greater
scientific advancement, and the creation of a healthier
America. Our fiscal year 2001 budget brings those goals within
reach without loosening our commitment to fiscal discipline or
to a balanced budget.
This budget is about people. It makes a record investment
in health care coverage, in access and in quality. Two years
ago, with bipartisan support, we launched the State Children's
Health Insurance Program. Two million children are now
enrolled.
Now we want to make sure that this new program, and
Medicaid, carry millions more children and their parents into
the safe harbor of quality health care. The President's Family
Care Program will do just that.
But even as we expand coverage to some parents through
Family Care, we recognize that many low income adults work in
jobs that do not offer health insurance. These workers
frequently rely on local health institutions and local
professionals who provide services at a reduced or no cost.
Secretary Herman has married a man who does exactly that. Dr.
Franklin is a family doctor.
And while he gets reimbursement from many parts of the
health care system, he told me the other night that he also
often has to offer reduced cost services to make sure the
families he has treated over the years, who might lose their
health insurance, continue to get that treatment.
This year we want to increase our support for community
service networks to $125 million, five times our investment
last year. We need to strengthen and modernize Medicare. First
and foremost, that means dedicating more than $300 billion of
the on-budget surplus over 10 years to extend the solvency of
the trust fund until 2025.
We also must add a voluntary prescription drug benefit to
Medicare. And I emphasize voluntary. As the President said in
his State of the Union message, we would never design Medicare
today without a prescription drug benefit. We cannot change the
past. However, we can change the future and catch up with
modern medicine. But the longer we wait, the worse the problem
will become. And the more expensive it will become.
Government cannot step into the shoes of parents and
communities. But government does have a role to play in helping
families balance work and children. One recent study notes that
in 1998 only 10 percent of the 14.7 million children eligible
for Federal child care subsidies received them.
So as part of the President's Child Care Initiative, this
year's budget adds another $817 million to the Child Care
Development Block Grant.
Senator Specter, you will recognize that exact amount,
because we talked about it during the appropriations process
last year. This is part of our discretionary budget and brings
the total block grant to $2 billion.
Mr. Chairman, Head Start is one of the most successful
bipartisan programs our two branches of government has ever
created for children. And this year we are requesting $6.3
billion for Head Start. That is $1 billion more than last year,
the largest increase in the history of Head Start. We believe
the program merits it.
I cannot talk, of course, about children without talking
about drugs, as you have yourself, Mr. Chairman. I know that
you would like to pursue this further in our question and
answer period.
We know that marijuana use has leveled off among teens, but
too many teens are still saying yes to drugs and alcohol. And
that is why our budget includes over $3.3 billion for substance
abuse treatment and prevention.
I mentioned the success we have had in cutting the death
rate from AIDS, but HIV/AIDS is still a disease without a cure.
And it is still the greatest public health challenge both here
and around the world. So fighting HIV/AIDS remains a top
priority for the department. Our total AIDS budget this year is
$9.2 billion, an increase of 8.4 percent over last year. Every
agency's AIDS-fighting budget is going up, in prevention,
treatment and research.
On the prevention side, we have proposed to add an
additional $75 million to help stop the spread of the disease.
Specifically, the CDC will direct $40 million of the new funds
to local communities, including prevention services to target
minority communities. CDC will spend another $26 million to
fight AIDS around the world.
And at the same time, the Health Resources and Services
Administration will spend $1.7 billion in Ryan White funding to
help people living with HIV/AIDS. This is a $125 million
increase over last year.
Our budget requests for AIDS-related research at NIH is
$2.1 billion, a 5.2 percent increase over last year. The total
NIH budget this year is $18.8 billion, $1 billion more than
last year. This subcommittee, of course, should take pride in
the unprecedented investment it has made in basic and clinical
research.
Our shared commitment to the National Institutes of Health,
and to producing quality science and quality scientists of the
next generation on both the NIH campus and at the great
research universities, is an extraordinary legacy.
Years from now, I predict we will see results beyond our
wildest dreams. And some of those results are certain to come
from the $73 million we intend to invest over 2 years to build
a National Neuroscience Research Center at the National
Institutes of Health. This will put all NIH brain research
under one roof. More important, the center will usher in what
is certainly to be the century of the brain.
In the interest of time, let me quickly mention three other
areas where we intend to increase our discretionary budget. We
take very seriously the need to stop infectious diseases and
bioterrorism.
Our budget increases by almost 50 percent CDC's funding for
disease surveillance. As for bioterrorism, which may be the
biggest threat of the 21st century, we are proposing to spend
$265 million to prepare for and respond to biological attacks.
We also want to make a major investment in bricks and
mortar. In addition to the Neuroscience Research Center at NIH,
CDC proposes to spend $127 million, $70 million more than last
year, to modernize and expand three critical laboratory sites.
The remaining funds will go towards completing the Edward R.
Roybal infectious disease lab and construction of a new
environmental health lab.
Mr. Chairman, I want to conclude my testimony by noting
that our greatest moral imperative is to close the gaps in
health outcomes between minorities and the majority population.
In 1998, the President set a goal of ending health disparities
in six major areas. Now almost every operating division of my
department is working to close these gaps.
That includes an additional $35 million for CDC for
community-based research and demonstration projects to reduce
disparities, money aimed at those communities themselves.
PREPARED STATEMENT
Thank you very much, Mr. Chairman and members of this
committee. I would be happy to join my colleagues a little
later to answer any questions you may have.
Senator Specter. Thank you very much, Secretary Shalala.
[The statement follows:]
Prepared Statement of Hon. Donna Shalala
Good morning, Chairman Specter, Senator Harkin, and members of the
Subcommittee. I am pleased to appear before you today to discuss the
President's fiscal year 2001 budget for the Department of Health and
Human Services. At the outset, let me thank you again, Mr. Chairman,
for your leadership on the prevention of youth violence and substance
abuse and on the treatment of mental health--issues which I will
discuss in detail later in my testimony. I am honored to be here with
Secretaries Herman and Riley to continue our dialogue and coordinated
efforts in these areas.
A PROUD HISTORY. . .
Mr. Chairman, before I discuss our plans for confronting the
challenges that lie ahead, I think it is important first to take a look
back at where we have been. Over the past seven years, we have worked
together to develop innovative solutions that have improved the health
and well being of all Americans. Let me note just a few of these
accomplishments:
--Working together, we have expanded enrollment in Head Start from
approximately 714,000 children in 1993 to an estimated 950,000
in this budget, while at the same time improving the quality of
the program, thereby providing a strong foundation for success
for hundreds of thousands of low-income children.
--Two years ago, the President called for an increase of almost 50
percent over five years in the NIH budget as part of his
Research for America Fund. Since that time the NIH budget has
increased by over $4.2 billion and, with the funding proposed
by the President this year, we will be ahead of schedule in
reaching our goal. In addition, we have increased the number of
Research Project Grants funded by the National Institutes of
Health by over 30 percent, from 23,952 in fiscal year 1993 to
31,524 in this budget. This represents a dramatic expansion of
our scientific knowledge base that will pave the way for
biomedical advances in the years ahead.
--We have nearly doubled the number of people receiving access to
comprehensive combination drug therapy under the Ryan White
Care Act AIDS Drug Assistance Program (ADAP), from almost
49,000 in 1994 to approximately 75,000 with this budget.
--We have improved the health of our seniors by increasing the number
of healthy meals served to older Americans under the
Administration on Aging's Nutrition programs from 240 million
in fiscal year 1994 to 279 million in this budget year.
--With the enactment of the Health Insurance Portability and
Accountability Act of 1996, we have helped individuals keep
their insurance when they change jobs, guaranteed renewability
of coverage, and helped ensure access to health insurance for
small business.
--Together with the states, we have undertaken the largest health
care coverage initiative since Medicare, namely the State
Children's Health Insurance Program. In just the two years
since its enactment, the number of children enrolled in SCHIP--
now almost 2 million--has doubled. In addition, the number of
states covering children up to 200 percent of poverty has
increased by more than sevenfold.
--Last year, the President signed into law the bipartisan Ticket to
Work and Work Incentives Improvement Act that allows people
with disabilities to maintain their Medicare and Medicaid
coverage when they go to work. It also includes a new
demonstration program that allows people with disabilities who
are still working and are not sufficiently disabled to qualify
for Medicaid to obtain coverage and reforms the training system
for people with disabilities.
--We created the Vaccines for Children Program, to finance
immunizations for children without private health coverage.
Childhood immunization coverage rates in 1998 were the highest
ever recorded. Ninety percent of toddlers in 1996, 1997 and
1998 received the most critical doses of each of the routinely
recommended vaccines, surpassing the President's 1993 goal.
We also have undertaken a number of new initiatives to target
emerging threats and address long-standing problems. We have launched
new initiatives to promote research on disease prevention and health
care quality, to improve the quality of nursing home care, to provide
support for our nation's children's hospitals, and to increase the
number of children adopted from our child welfare systems. To educate
Medicare beneficiaries about their health care options, we have
implemented the largest peacetime outreach campaign ever undertaken by
the federal government. We have stepped up efforts to increase the
availability of substance abuse treatment, to eliminate racial and
ethnic health disparities, and to address the AIDS crisis in minority
communities. And we have invested significant resources to prepare the
nation to respond to the medical and public health consequences of
chemical and bioterrorist attacks. We have launched new initiatives to
protect the rights of Americans in managed care and protect the privacy
of electronic medical records, and most recently, to improve patient
safety and reduce preventable medical errors in our health care
systems.
While we should be proud of past accomplishments, we must continue
to address ongoing health and human services challenges. These include:
expanding access to quality health care and extending protections to
the uninsured and at-risk; supporting working families and bettering
the lives of our nation's children; encouraging greater scientific
advancement; and creating a healthier America.
Thanks to our continuing economic prosperity, we have a great
opportunity to meet these challenges. In the last two years, we have
recorded back-to-back surpluses for the first time since the 1950's.
The combination of a strong economy, fiscal discipline, and
unprecedented advances in our scientific knowledge give us the
opportunity to make the investments needed to build on all of our
achievements over the last seven years.
Mr. Chairman, the total HHS budget request for fiscal year 2001 is
$421.4 billion (Outlays). The amount before this subcommittee totals
$267 billion (BA), of which $44.8 billion is discretionary. This
discretionary component represents an increase of $4.5 billion over
last year. Let me now highlight the main components of our fiscal year
2001 budget request.
EXPANDED HEALTH CARE COVERAGE
We live in an age of remarkable advances in the biomedical
sciences. Yet too many of our citizens are denied the benefits of these
advances because they lack access to quality, affordable health care.
Throughout his Administration, President Clinton has made expanding
access to health care one of his most important goals. Working with the
Congress, we have had some notable successes, including enactment of
the State Children's Health Insurance Program, which today covers
nearly 2 million children; the Health Insurance Portability and
Accountability Act, which allows workers to keep health insurance
coverage when they change jobs and limits the ability of insurers to
deny coverage based on pre-existing conditions; and most recently, the
Ticket to Work and Work Incentives Improvement Act, which allows
disabled Americans to return to work without losing their Medicare and
Medicaid coverage.
But even with these successes, approximately one-seventh of the
population still lacks health insurance. Our budget seeks to address
these problems through a number of initiatives designed not only to
expand access to care but to improve the quality of health care as
well.
Expanding coverage under Medicaid and SCHIP
The State Children's Health Insurance Program (SCHIP), enacted in
1997, now provides nearly two million low-income, uninsured children
with access to health insurance, preventive medicine, and
immunizations. While the success of the SCHIP program has greatly
enhanced the health of these children, many of their parents remain
uninsured. And there still are many children who are eligible for
Medicaid and SCHIP who are not currently enrolled. With the country's
resources growing, the economy booming, and the SCHIP program showing
great progress, it makes sense to take advantage of this opportunity to
implement new options for low-income working families without health
insurance. The President's budget includes proposals to create a new
``FamilyCare'' program that expands coverage to the parents of children
eligible for Medicaid and SCHIP, increase outreach efforts, and
simplify the enrollment process.
Under FamilyCare, parents would be enrolled in the same programs as
their children, and states would receive the higher SCHIP matching
payments for expanding coverage to parents. To ensure that the original
intent of the SCHIP program is met, states would be required to expand
eligibility for children up to 200 percent of poverty before accessing
funds to cover parents. As is the case with children, priority in
enrollment would be given to lower-income parents before covering
higher-income parents.
If, after five years, some states have not expanded coverage of
parents to at least 100 percent of poverty, they would then be required
to do so. By 2006, all poor parents would be eligible for coverage just
as their children are today. We believe that enrolling parents in
Medicaid or SCHIP will not only improve their health, but will also
make it easier for entire families to access insurance through one
source, thereby increasing the number of children participating in the
program. This FamilyCare initiative is a practical, targeted approach
to encouraging greater insurance coverage. Over eighty percent of
parents of uninsured children under 200 percent of poverty are
themselves uninsured, while nearly two-thirds of uninsured parents (6.5
million) have children eligible for Medicaid or SCHIP. The budget
proposes to extend and improve the transitional Medicaid program, which
provides important health insurance coverage for families moving from
welfare to work. Our proposals would use existing state administrative
and delivery systems and no new bureaucracies would be needed.
In addition to covering parents, states also will be given the
option to extend Medicaid coverage to young people ages 19 and 20. If
they do, they will also have the option to cover kids up to age 20
under SCHIP. To further increase Medicaid and SCHIP enrollment, the
President's budget supports new efforts to simplify eligibility and
aggressively expand efforts to enroll eligible children identified
through school lunch programs. To ensure that children are not
overlooked in States that have different rules and procedures for
Medicaid and SCHIP, we also propose to require that States conform
certain eligibility rules between Medicaid and SCHIP. Our budget also
proposes $10 million in mandatory funding for competitive grants to
States that develop innovative plans for outreach to the homeless and
the coordination of services across the Medicaid, SCHIP, TANF, Food
Stamps, and Mental Health and Substance Abuse programs. If they do,
they also will have the option to cover kids up to age 20 under SCHIP.
Finally, our budget seeks to reverse some of the inequities that
have resulted from the 1996 welfare reform legislation by giving states
the option to provide Medicaid or SCHIP coverage to legal immigrant
children and pregnant women. The budget also proposes to restore SSI
and Medicaid eligibility to legal immigrants who entered the United
States after the enactment of welfare reform, become disabled and live
in the U.S. for five years. Parents of legal immigrant children would
also be eligible for coverage under our FamilyCare proposal. In
addition, the budget seeks to restore Food Stamps eligibility to legal
immigrants who were in the country before the enactment of welfare
reform and either subsequently reach age 65 or have children who are
eligible for Food Stamps.
In addition, the budget will take an important step to improve the
health of low-income Americans by ensuring that they have access to
drugs that help them quit smoking. The budget will ensure every state
Medicaid program covers both prescription and non-prescription smoking
cessation drugs, removing a special exclusion now in law, and requiring
states to cover these drugs as they cover all other FDA-approved drugs.
Modernizing and strengthening Medicare
For the last thirty-five years, Medicare has been the cornerstone
of our efforts to ensure that all seniors have access to the quality
health care they need and deserve. However, since its enactment in
1965, much in the health care system has changed, not only the types of
care provided and the setting in which these services are performed,
but also the makeup of the population that receives Medicare. These
changes have dramatically increased the financial strains on the
Medicare program, and current actuarial projections show that by
approximately 2015, just as the large baby-boom generation is becoming
eligible, Medicare may be faced with insolvency.
The Clinton-Gore Administration budget also dedicates $432 billion
over ten years to Medicare to extend the solvency of the Trust Fund
until at least 2025 and to create a voluntary, affordable prescription
drug benefit. It includes a new, multi-billion dollar reserve fund that
can be used to add protections against catastrophic drug costs to the
President's proposed drug benefit. This financing commitment is part of
a comprehensive plant to modernize and strengthen Medicare to ensure
that it can continue to deliver high quality, affordable care in the
21st Century. These steps include making the program more competitive;
introducing private sector purchasing and management tools; and
continuing our historic fight against fraud, waste, and abuse.
Over the last thirty-five years, the development of new
prescription drugs to treat a variety of conditions has helped
Americans to live longer and higher quality lives. The centerpiece of
the President's plan to modernize Medicare is a voluntary prescription
drug benefit that would be affordable and accessible to all
beneficiaries. This benefit, which would rely on market competition to
obtain lower prices, would have no deductible, and would pay half of
all costs up to $2,000 in fiscal year 2003, increasing to $5,000 by
fiscal year 2009. The plan would fully pay for costs for beneficiaries
with incomes below 135 percent of the poverty level, and provide
premium assistance for those with incomes between 135 and 150 percent
of the poverty level, while providing financial incentives to employers
to continue offering prescription drug benefits to current retirees.
The President's budget also proposes much-needed incentives to
increase the utilization of preventive services by Medicare
beneficiaries. Our plan would eliminate existing coinsurance and
deductibles for covered preventive benefits, including colorectal and
prostate cancer screenings, pelvic exams, mammographies, bone mass
measurement, and diabetes self-management. The President also is
planning to develop a three-year demonstration for smoking cessation
services. By lowering the cost and expanding the availability of these
services, we will not only save lives, but will minimize the need for
more extensive, and expensive, treatments in the future.
While we work to strengthen Medicare to better serve current
beneficiaries, our budget also includes proposals to expand access to
Medicare to groups who face barriers to health insurance coverage.
These proposals will allow Americans ages 62 to 65 to buy into Medicare
by paying a premium, provide a similar buy-in option for displaced
workers ages 55 to 62 who have lost employer-provided health coverage,
and provide COBRA coverage to retirees between the ages of 55 and 65
whose companies have reneged on their promise to provide health
benefits. To make these buy-in options more affordable, the budget
includes a proposal for a tax credit, available to displaced workers
over age 55 as well as all eligible persons ages 62 to 64, that would
be equal to 25 percent of the buy-in premiums.
As important as our efforts to modernize the Medicare benefit
package are, Medicare recipients will be able to realize the full
benefits of these new services only when we give equal attention to
strengthening and modernizing the management of our health programs.
The President's budget continues efforts to improve the Health Care
Financing Administration's (HCFA) management, building on the five-part
reform plan advanced last year to increase flexibility while also
increasing accountability. Our budget also maintains our commitment to
fighting fraud and abuse, investing in a new Medicare contractor
oversight initiative to address a number of concerns outlined in OIG
and GAO reports last year. This initiative includes funding to improve
evaluation of program operations, establish financial management
controls at each contractor, develop an integrated general ledger
accounting system that will ensure clean audit opinions into the
future, and monitor and oversee these changes at all contractors.
These actions will augment the successful efforts we have
undertaken in partnership with you, Mr. Chairman, and Senator Harkin to
combat fraud, waste, and abuse in the Medicare and Medicaid programs.
As you know, the Department of Justice recently announced that, in
conjunction with HHS, it had achieved a $486 million settlement with a
national health provider that had been defrauding the Medicare program.
This action is in addition to results reported in latest Health Care
Fraud and Abuse Control account report that indicated that $490 million
had been collected as a result of successful prosecutions in 1999. Of
that amount, $369 million was returned to the Medicare trust funds. In
addition, the Medicare Integrity Program reported an increase of 25
percent in total overpayments prevented and identified in the first six
months of fiscal year 1999 compared to the same period the year before.
These successful efforts are why the latest Medicare Trustees' Report
included this Administration's fraud and abuse efforts as a
contributing factor in slowing the rate of growth of the Medicare
program.
Increasing access to health care for uninsured individuals
Those who lack health insurance often are forced to rely on
emergency rooms or ad-hoc networks of facilities and individual health
professionals for whatever care they are able to receive, or to forgo
any health care at all. Last year, the President's budget requested $25
million to launch a new initiative to help community health clinics,
public hospitals, academic health centers, and other institutions
serving the poor to create new systems of comprehensive and coordinated
care that uninsured workers and their families could depend on, and
Congress responded by fully funding this request. To continue this
effort, this year the President is proposing to increase funding for
this initiative to $125 million. This increase will allow as many as 40
to 60 additional communities to receive grants to improve the capacity
of safety-net providers. The President's budget also continues to
provide strong support for the nation's Community Health Centers, which
provide care to nearly 10 million low-income and uninsured individuals
in rural and inner city areas. Our budget requests $1.1 billion to
support Community Health Centers, an increase of $50 million over last
year.
Long-term care
With more Americans now living longer than ever before, one of the
most pressing demands we face is the increasing need for long-term care
services. Studies show that the great majority of individuals who need
long-term care prefer to remain in their own homes and communities
rather than receive care in institutional settings, but this places a
heavy burden on the family members and friends who must provide
supports for them. More than half of these caregivers are women, and
one-third have full time jobs. Our budget seeks to address the pressing
need for new long-term care solutions through a multi-faceted
initiative designed to help both the millions of Americans who require
long-term care and those who care for them.
Our budget invests $125 million to support family caregiver
activities in the Administration on Aging (AoA). This initiative will
provide States and local communities with the flexibility to design and
provide caregiver support activities to approximately 250,000 families
nationwide who are caring for elderly relatives with chronic diseases
and disabilities. Services provided will include quality respite care,
information about local services, counseling, and training for complex
care needs.
The budget also proposes $140 million over five years to expand
access to home and community-based care services under Medicaid through
an option to equalize income eligibility standards for those who need
institutional care but choose to live in the community. This long-term
care initiative also includes a $3,000 tax credit to provide support
for those with long term care needs and those who care for a disabled
or elderly relative; an innovative housing initiative to integrate
assisted living facilities and Medicaid home and community based care
settings; and a program to provide Federal employees, annuitants and
their families with the opportunity to purchase private long-term care
insurance at group rates.
Nursing home quality initiative
As we begin to develop a support system for those who choose to
receive long term-care in home and community-based settings, we must
also continue to ensure that nursing home residents are receiving the
highest quality care possible. The fiscal year 2001 budget includes $71
million for continuing quality monitoring activities in last year's
budget to improve federal and state oversight of nursing homes. Now in
its third year, this initiative supports the efforts of states to
strengthen enforcement and oversight of nursing home quality and to
crack down on those who repeatedly violate program standards. Expanding
on activities already underway, funding will support increased surveys
of repeat offenders, improved training for surveyors, and enhanced
legal services including resolution of the backlog of appeals.
RENEWED SUPPORT FOR CHILDREN AND FAMILIES
Mr. Chairman, these investments in health care access and quality,
in improving our public health system, and in broadening our scientific
knowledge, all are fundamental to making sure that the new century is a
time of good health and prosperity for all Americans. But just as we
honor our commitments in the health arena, we also keep our commitments
to improving the lives of the nation's children and families. The
President's budget keeps our promise to work toward an America where
every child, and every family, has the opportunity to succeed at work,
at school, and at home.
HHS YOUTH VIOLENCE PREVENTION ACTIVITIES
HHS is pursuing a range of activities to assist in the prevention
of youth violence, and we have requested $78 million for these
activities. The Safe Schools/Healthy Students Initiative is an
unprecedented collaborative effort involving this Department, along
with the Departments of Education and Justice. SAMHSA is our lead
agency for this important effort. Through this initiative, we are
assisting 54 school districts in designing and implementing
comprehensive educational, mental health, social services, law
enforcement and juvenile justice services for youth. The increase in
this program provided by the Congress for fiscal year 2000 will enable
us to increase that number to 70-75 Safe Schools/Healthy Students
grants by the end of the fiscal year. In addition to its support for
this partnership, SAMHSA has developed a comprehensive set of
activities to provide direct grants for exemplary practices as well as
a variety of activities for developing innovative technology, technical
assistance, evaluation and social marketing in the youth violence
prevention arena.
The Surgeon General is developing a Report on Youth Violence that
may be completed this year. Local communities, private organizations,
academia, other federal departments, state and local governments, and
other groups are providing information and assistance to ensure the
report soundly addresses the prevention of youth violence. In addition,
CDC is engaged in a variety of activities including research on school
violence and suicide prevention. For example, CDC will evaluate
programs for high risk youth and publish and disseminate The Best
Practices to Prevent Violence by Children and Adolescents: A Sourcebook
based on the input of experts from across the nation. CDC also will
initiate National Centers of Excellence on Youth Violence and a
National Youth Violence Prevention Resource Center. The Administration
for Children and Families (ACF) is proposing to build on these efforts
by focusing on the mental health needs of runaway and homeless youth.
NIH research has demonstrated behavioral interventions in the home
and classroom that address violence in children with behavioral
disorders and is developing and improving programs aimed at prevention,
early recognition, and intervention for youth violence in various
community settings. Finally, the President has convened a White House
Council on Youth Violence, which includes representatives from the
Departments of Treasury, Labor, Justice, and Education. The Council's
duties include developing a citizens' information hub; producing
reports on youth violence; expanding the Safe Schools/Healthy Student
model of collaboration; providing tools for parents to deal with the
issue of youth violence; coordinating the federal research agenda; and
developing further policy responses.
Expanding substance abuse activities
Even with all our efforts over the last few years to expand the
availability of services to those addicted to drugs and alcohol, there
continues to be a significant gap between the need for substance abuse
treatment and the capacity available to provide treatment. Estimates by
the Office of National Drug Control Policy show that less than half of
the five million individuals who need substance abuse treatment
actually receive these services. To further close this gap, the
President's budget includes a total of $3.3 billion in HHS for
substance abuse treatment and prevention, including $2 billion to
support SAMHSA's substance abuse prevention and treatment activities.
Included in this request is an additional $54 million for Targeted
Capacity Expansion grants to support rapid and strategic responses to
emerging areas of need. The request also includes an increase of $31
million for the Substance Abuse Block Grant, which will provide funding
through the states for over 10,500 community-based treatment and
prevention organizations. In all, our budget request will enable more
than 16,000 additional individuals to access treatment services.
Improving mental health services
The Surgeon General's Report on Mental Health, released in December
1999, has focused new attention on the plight of those who suffer from
mental illness. While about one in five Americans experiences a mental
disorder in the course of a year, many of them will not receive the
treatment they need. To address this problem, the President's budget
proposes an increase of $100 million for mental health services
provided by the Substance Abuse and Mental Health Services
Administration (SAMHSA). This includes an increase of $60 million for
the Mental Health Block Grant, to support state efforts to create
comprehensive, community based systems of care for both adults and
children. It also proposes to create a new $30 million Targeted
Capacity Expansion Grant program to support prevention and early
intervention services, as well as local service expansion.
Improving access, affordability, and quality of child care
For the millions of American families in which parents must work to
support their children, the availability of child care is often the
difference between self-sufficiency and dependency. But even though
funding for child care has doubled under the Clinton Administration,
recent studies showed that in fiscal year 1998 only ten percent of the
children potentially eligible for federal child care subsidies received
them. As we have said before, no parent should be forced to choose
between the job they need and the child they love. We must take steps
to close this gap and help all parents find child care that is safe,
reliable, and affordable.
As we close this gap, we also must continue to improve child care
quality. Study after study has shown that safe, quality child care is
essential to the healthy development of our children. But the lack of
quality care has forced too many parents to place their children in
less than desirable settings, and even low quality care can place a
heavy financial burden on low-income families. The President's budget
builds on our ongoing efforts to remedy these deficiencies with a
comprehensive initiative designed to not only make child care more
affordable but also to improve the quality of care.
Our fiscal year 2001 budget requests an additional $817 million,
for a total of $2 billion, for the discretionary Child Care and
Development Block Grant. This increase will provide child care
subsidies to almost 150,000 additional low-income children. Also
included in the $2 billion total is $223 million to improve the quality
of care, of which $50 million is for infant and toddler quality care
efforts; $19 million is for school-aged care and resource and referral
activities; and $10 million is for ongoing research, demonstration, and
evaluation programs. Our budget also proposes an increase of $3 billion
in mandatory funding over five years, including $600 million in fiscal
year 2001, to establish an Early Learning Fund. This fund will provide
money to states to offer community level challenge grants for programs
that improve childhood development and school readiness and the quality
and safety of care. The President's Child Care Initiative also includes
critical increases for activities in the Departments of Treasury and
Education.
Enhancing head start
Since its enactment thirty-five years ago, the Head Start program
has been one of our greatest success stories, ensuring that millions of
low-income children start school ready to learn. In 1993, the Clinton
Administration set the goal of enrolling one million children in Head
Start by fiscal year 2002. The President's $6.3 billion request for
fiscal year 2001, an increase of $1 billion, will keep us on track to
realize this goal, increasing the number of children enrolled to nearly
950,000. A portion of these funds will be reserved for grants to
unserved and under-served populations. Consistent with the focus of the
1998 reauthorization of Head Start to improve the quality of services,
$418 million of the proposed increase will be targeted for reducing
class size, improving facilities, staff training, and school readiness;
obtaining safer and better equipment; and attracting and retaining top-
quality staff. Finally, our Head Start budget request includes $564
million for the Early Head Start program, which will provide 54,000
infants and toddlers and their families with continuous and
comprehensive child development and family support services.
Increasing parental responsibility through child support enforcement
One of the key underpinnings of this Administration's support for
working families is the idea of encouraging personal responsibility.
Nowhere is this more evident than in our actions to step up child
support enforcement, which is a critical support for children and
families. Child support collections have almost doubled since 1992,
reaching an estimated level of $15.5 billion in fiscal year 1999. Our
package of child support enforcement proposals is self-financing and it
increases collections to families by more than $1.8 billion over five
years. These proposals build on our success in the program through
changes designed to give states new options to get more money to
families and to improve enforcement tools to increase collections.
These actions are part of a comprehensive Administration initiative to
promote and ensure that non-custodial parents who can afford to pay
child support do so, and helping low-income non-custodial parents go to
work so that they can support their children through ``Fathers Work''
grants in the Department of Labor's budget. Under one proposal, we
would match State efforts to allow families still working their way off
welfare to keep a portion of the child support they are owed,
increasing payments to these families by $388 million over five years.
A second proposal provides States with the option to simplify their
rules for distributing child support to ensure that families that have
left welfare will keep all the child support paid by the non-custodial
parent, resulting in increased payments to families of $815 million
over five years. Both of these proposals build on our Family First
distribution policies. Our package also includes proposals for better
enforcement techniques and program improvements that will save the
Federal government nearly $600 million over five years while increasing
payments to families by over $650 million.
Ensuring continued educational excellence in the nation's children's
hospitals
As we move to increase the number of children with health
insurance, we also must continue our efforts to ensure that all
children receive the highest quality care. Expertly trained
pediatricians are a critical ingredient in providing high quality care
to children, and children's hospitals play an essential role in their
education, training over 25 percent of all pediatricians and the
majority of pediatric specialists. Last year, the President proposed a
new $40 million program to support the vital role children's hospitals
play in training physicians. This year, our budget proposes to double
this amount, providing $80 million to raise support for approximately
60 free-standing children's hospitals to a level more consistent with
other teaching hospitals.
Advancing innovative treatments for asthma
Approximately 5 million of our nation's children suffer with
asthma, and children from low-income families are disproportionately
affected. What makes this particularly disconcerting is that the number
of children afflicted has doubled over the past 15 years, with the
sharpest increases in rates among children under age 5. Asthma is a
leading cause of school absenteeism, and children who suffer from
asthma are often forced to limit their activities. To address this
growing health problem, our budget proposes $100 million over two years
in demonstration grants to states to test innovative asthma disease
management techniques for children enrolled in Medicaid and SCHIP.
Through appropriate clinical disease management, these programs will
attempt to reduce asthma related incidents and keep children with
asthma out of emergency rooms and in school.
Providing heating and cooling assistance to low-income families
The Nation has been severely affected by this winter's fuel oil and
propane price increases which, in some cases, have doubled since last
year. On February 16, the President took steps to respond to critical
needs by releasing all remaining emergency Low Income Home Energy
Assistance Program (LIHEAP) funds for this year, bringing the total
heating assistance funds released this winter to $295 million. On
February 25, the President submitted a supplemental request to Congress
for an additional $600 million in contingent emergency LIHEAP funding
to help as many people as possible meet the additional heating costs
and to establish an emergency reserve in the event of a severe summer
heat wave. It is essential that Congress act quickly on this request to
help to relieve the burden of rising fuel bills. To further address
this problem, I have encouraged States to take advantage of the
flexibility of current law to reach families with high energy needs,
including the option of raising State LIHEAP income eligibility limits.
Federal law allows States to set income eligibility limits at the
greater of 150 percent of the poverty level or 60 percent of State
median income. I also have encouraged States to fully utilize their
options under TANF to ensure low income families with children receive
the assistance they need.
GREATER SCIENTIFIC ADVANCEMENT
As we enter the new millennium, we stand on the cusp of an era of
that promises unprecedented scientific advances. However, these
breakthroughs only will be realized if we continue to make the
necessary investments in biomedical research. Our budget continues
along the path we set several years ago by investing in basic
biomedical research as well as in research that will lead to
improvements in the quality of care, thereby moving important
scientific discoveries from the laboratory into our hospitals and
clinics.
Investing in biomedical research
Biomedical research has been at the center of the unprecedented
gains we have made in improving the health and quality of life for all
Americans. Breakthroughs that did not seem possible only a few years
ago are now within our reach, but it will require a sustained
investment for these endeavors to bear fruit. The President's fiscal
year 2001 budget includes almost $19 billion, an increase of $1 billion
over last year's funding level, for biomedical research at NIH. This
increase will support research in such areas as diabetes, brain
disorder, cancer, disease prevention strategies, and development of an
AIDS vaccine, and eventually lead to a revolution in our ability to
detect, treat, and prevent disease. This request will enable NIH to
fund 31,524 research project grants, the highest total in history, and
enhance activities in critical areas such as research on racial and
ethnic health disparities, biomedical information and technology,
clinical research, and genomics.
Using science to improve quality of care and reduce medical errors
As we make new breakthroughs in biomedical research, we also must
work to see that these scientific advances result in better quality
health care. Even with all our scientific innovations, a recent study
by the National Academy of Sciences' Institute of Medicine estimated
that as many as 98,000 Americans die each year due to medical errors.
The Quality Interagency Coordination Task Force, which HHS leads, just
released its report, Doing What Counts for Patient Safety: Federal
Actions to Reduce Medical Errors and Their Impact, which incorporates
and expands on the report of the Institute of Medicine (IoM). Our
report also builds on the extensive and thoughtful review of the
medical errors issue that has been undertaken by this subcommittee. Our
budget dedicates $20 million in the Agency for Healthcare Research and
Quality (AHRQ) and $13 million in the Food and Drug Administration
(FDA) for new activities to address medical errors and patient safety.
In addition, HCFA will require that hospitals implement medical error
reduction and patient safety programs in order to meet Medicare's
conditions of participation.
Overall, our budget invests $250 million in AHRQ to support
research activities that will improve quality of care, and produce
better health outcomes. These resources will be used to step up
research efforts on the uses and tools of health information
technology; sponsor clinical prevention research and research to
enhance patient safety and reduce medical errors; and expand research
on issues of workers' health. These activities will help us to learn
how best to translate knowledge into daily practice and improve health
care for all Americans.
Our budget also invests and additional $20 million to implement a
new Health Informatics Initiative designed to improve patient care and
health outcomes through the efficient and effective use of data and
information. This request will fund a set of cross-cutting and agency-
specific investments in information systems and health data, thereby
enabling HHS to assume a greater national leadership role in the
establishment of health data standards while also strengthening the
information base for decision-making, improving the uniformity and ease
of transmission of health care data, and protecting the confidentiality
of health information. In addition, our budget includes $45 million to
enhance the Food and Drug Administration's post-market activities. This
includes funds to expand their adverse-event reporting system and to
allow FDA to investigate, identify and prosecute those selling
prescription drugs over the Internet without proper certification.
Food safety initiative
Enhancing our capabilities to conduct surveillance also will help
us in our ongoing fight against the threat of food borne diseases.
Estimates show that food-related hazards are responsible for as many as
76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each
year. To combat these outbreaks, the budget seeks a $10 million
increase for CDC's Food Safety Initiative programs. These funds will
support enhanced public education efforts and the continued expansion
of the PulseNet network of health labs. This award-winning network
performs DNA ``fingerprinting'' of disease causing bacteria, enabling
public health agencies to identify and respond more rapidly to disease
outbreaks. In addition, the FDA is seeking an increase of $30 million
for its Food Safety Initiative activities. These funds will be used to
increase inspections so that all high risk food establishments are
covered, expand the number of examinations of imported foods, increase
laboratory capacity, broaden efforts to work with states and the
industry to make standards more consistent, and in conjunction with the
Department of Agriculture and the states, begin to implement the Egg
Safety Action Plan prepared by the President's Council on Food Safety.
CREATING A HEALTHIER AMERICA
Expanding access and improving the quality of health care are
crucial steps toward ensuring that all Americans live long, healthy
lives. But new threats to public health continue to emerge, and many
long standing health problems still pose considerable risks. From AIDS
prevention and treatment to food safety and the control of infectious
disease, our fiscal year 2001 budget continues our work to vigorously
safeguard the public health.
HIV prevention initiative
As a nation, we have made substantial progress in our fight to
prevent the spread of HIV and AIDS. Thanks to the use of combination
anti-retroviral therapy, the AIDS death rates in the United States
continue to decline. But in some parts of the world, and in some
communities in the United States, the virus continues to spread
rapidly. Domestically, the impact of HIV among certain segments of the
population, especially minority communities, continues to be severe. In
1997, 45 percent of those newly diagnosed with AIDS were African
American and 20 percent were Hispanic. Globally, the AIDS pandemic
continues to be a major threat, particularly in developing countries.
In sub-Sahara Africa, for example, it is estimated that four million
people each year are newly infected with HIV. Internationally, the
President's budget includes an increase of $26 million for the Centers
for Disease Control and Prevention to continue the initiative
undertaken last year to prevent the spread of HIV in developing
countries.
Domestically, our budget request supports our ongoing initiative to
reduce the spread of HIV and AIDS in minority communities. It provides
an increase of $50 million (including $10 million in reallocated
funding) for CDC's domestic prevention programs to encourage
individuals at risk to avoid behaviors that can result in the
transmission of the disease. These funds will be directed to community
based interventions designed to reduce the rates of HIV infections,
with special emphasis on vulnerable populations including racial and
ethnic minorities, women, injection drug users and their partners, and
young gay men. Internationally, the President's budget includes $61
million for Centers for Disease Control and Prevention (CDC), an
increase of $26 million, to continue the initiative undertaken last
year to prevent the spread of HIV in developing nations.
Ryan White
Up to one-third of the 750,000 Americans living with HIV are
currently not in care. As we step up our efforts to prevent the spread
of AIDS, we must also continue to help those who already suffer from
this deadly disease. The President's budget keeps this commitment by
providing $1.7 billion for the Ryan White Program, an increase of $125
million. These additional funds will provide primary medical care,
pharmaceuticals critical to treatment, and other critical support
services for those living with HIV and AIDS. This includes an increase
of $26 million for the AIDS Drug Assistance Program (ADAP), which will
allow a total of approximately 75,000 individuals to receive
comprehensive combination drug therapy.
Reducing racial health disparities
One of the long-standing priorities of this administration has been
making sure that all people receive the highest quality health care,
regardless of their race or ethnicity. Unfortunately, members of
minority groups, including American Indians and Alaska Natives,
continue to bear a disproportionate burden of the nation's disease and
illness. The President's budget continues the effort to eliminate these
health disparities. A targeted response to this problem is the request
of $35 million to expand CDC's program of demonstration projects in six
identified areas of health disparities: infant mortality, cancer, heart
disease, diabetes, HIV/AIDS, and immunizations. Funds will support the
continuation of ongoing projects and the development of projects in two
new communities. The budget also proposes increasing funding for the
Office for Civil Rights by nine percent, including new program
resources to ensure that our racial health disparities initiative has a
strong civil rights nondiscrimination component. We also request an
increase of $230 million for the Indian Health Service, the largest
funding increase in two decades, to implement a multi-pronged effort to
improve the quality of care for Native Americans.
Family planning
Support for family planning services has been a key factor in
preventing over one million unintended pregnancies each year. Family
Planning Clinics provide a range of valuable services including
sexually transmitted disease and cancer screening and prevention; HIV
prevention and education; and contraception services and counseling. As
part of our strategy to prevent teen pregnancies, these services have
also contributed to reducing the teen pregnancy rate to its lowest
level on record (since 1976). Our fiscal year 2001 budget request
continues our strong commitment to family planning services, providing
an increase of $35 million over fiscal year 2000. These funds will
support grants to family planning clinics which will enable
approximately 5.75 million low-income clients to receive reproductive
health services and clinical care.
Preventing emerging infectious diseases
Thanks to the extraordinary advances in transportation and other
technologies and the expansion of international commerce, we truly live
in a global community. While these advances have resulted in numerous
economic and cultural benefits, they also have placed increasing
strains on our public health system. Since 1970, more than 35 new
infectious diseases have been identified. More recently, we have begun
to see the emergence of drug-resistant bacteria and viruses, and the
spread of older diseases to areas where they were previously unseen,
such as the recent outbreak of West Nile encephalitis in the New York
City area. To combat these threats, our budget requests a total of $202
million to support infectious disease prevention activities at the
Centers for Disease Control and Prevention. This includes an increase
of $26 million to fight emerging infectious diseases, of which $20
million would be used to support the development of a national
electronic disease surveillance system, which will enhance the ability
of state and local health offices to respond to multi-state outbreaks
of diseases and to share information, both among themselves and with
CDC.
Combating bioterrorism
The recent arrests of suspected terrorists at the Canadian border
has reminded us all of the serious threat that terrorism poses to the
peace and prosperity of our nation. The threats posed by bioterrorism
are particularly deadly because of their communicability and their
ability to remain undetected for long periods of time. Continuing our
efforts to prepare for and respond to the consequences of a
bioterrorist event, the Department's budget includes $265 million for
activities across agencies to mount a comprehensive public health
effort to combat this deadly threat. This strategy includes four major
components. First, our budget strengthens critical components of our
public health infrastructure, including our surveillance systems,
epidemiological and laboratory capacity, and communications technology.
Second, it continues funds for the purchase of a stockpile of the
pharmaceuticals needed to treat the most likely biological agents.
Third, it provides funds for research, development, and regulatory
review of new vaccines and new diagnostic screens for chemical agents.
Finally, it would support the establishment of an additional 25 local
area health care response systems, bringing the total number around the
country to 97.
Investing in HHS laboratory and health infrastructure
To successfully overcome the public health challenges of the 21st
century, we must invest now to modernize the infrastructure that
provides the foundation for our public health and biomedical research
systems. Many of the laboratories at CDC and FDA are overcrowded and
outdated, while at the National Institutes of Health (NIH) the
fragmentation of laboratory space delays the pace at which new
discoveries are made. Our budget requests substantial increases to
solidify this foundation and construct state-of-the-art facilities. For
CDC, we are requesting a total of $127 million, an increase of $70
million, for laboratory construction at three sites. First, our budget
includes $85 million in fiscal year 2001 and additional funding in
fiscal year 2002 and fiscal year 2003 to construct a laboratory to
handle the most highly infectious and lethal pathogens studied at CDC,
as well as housing important work on antibiotic resistant diseases,
AIDS, sexually transmitted diseases, and tuberculosis. Second, we
request $20 million to complete and equip the Edward R. Roybal
infectious disease laboratory. Third, we request $4 million to design a
facility to replace our antiquated environmental health laboratory. The
remainder of the request will be used for security improvements and
maintenance of existing facilities.
For NIH, we are requesting $149 million for intramural buildings
and facilities. Intramural projects include $73 million over two years
to construct a new facility to house the new National Neuroscience
Research Center, and $24 million to begin design and construction of a
new centralized animal facility. Our budget also includes $20 million
for new lab construction at FDA, as well as $65 million for health
facilities construction in the Indian Health Service (IHS).
RIGOROUSLY EVALUATING PROGRAM PERFORMANCE
Our budget request for fiscal year 2001 presents the annual
performance information required by the Government Performance and
Results Act (GPRA) of 1993. Notably, this includes the first GPRA
performance report of HHS and its components, which compares fiscal
year 1999 results to the goals in our fiscal year 1999 performance
plan. Although GPRA reporting must mature before its full value will be
realized, our performance report for this year shows improvements for
critical HHS initiatives of the past few years. SAMHSA reports that
retailers in more States have complied with rules prohibiting tobacco
sales to youth than we had projected in our 1999 performance plan. HCFA
achieved its 1999 goal for reductions in Medicare payment errors a year
early, and pursues increasingly rigorous goals in fiscal year 2001 and
fiscal year 2002. ACF and its program partners, including states,
exceeded performance expectations when they moved 1.3 million welfare
recipients into new employment. Information like this demonstrates that
GPRA can be a valuable tool that will enhance our efforts to improve
programs that serve the American people. As our performance measures
continue to mature and performance trends emerge, the GPRA data will
serve as important program indicators to support the identification of
strategies and objectives to continuously improve programs across HHS.
A ROAD MAP TO A BETTER AMERICA
Mr. Chairman, as I look back at the journey we have taken, I feel
tremendous pride in what we have been able to accomplish. While there
were occasional bumps in the road and we did not reach every
destination we set out for, we have made great advances in improving
the nation's health and well being. Today I have placed before you a
road map for the destinations we have charted--improving health care
access, coverage, and quality; making America a healthier and safer
place; expanding our scientific knowledge, and giving all our children
and families the opportunity for success--and these are destinations we
all wish to reach. Thanks to the unprecedented economy, our fiscal
discipline, and a new age of scientific breakthroughs, the conditions
under which we set out on this road have never been more favorable.
FISCAL MANAGEMENT AT CDC
Mr. Chairman, before concluding, I would like to speak about the
recent news stories regarding the management of hantavirus funding at
CDC. Dr. Koplan and I are deeply concerned about CDC's failure to
report these reallocations to the Congress in a timely fashion. I
strongly believe that the full accountability and integrity of our
budgeting and reporting efforts are central to our responsibilities,
and I have zero tolerance for inaccurate reporting or inaccurate
statements. We have an obligation to expend our funds consistent with
congressional expectations and to report in an accurate and timely
fashion.
In consultation with Dr. Koplan, I am taking what I consider to be
aggressive and unprecedented actions to rectify this problem and
restore the trust of this Congress. These actions, which will be
coordinated by the Department and CDC, include:
--The Chief Financial Officer (CFO) of the Department of Health and
Human Services (HHS) will take such actions as necessary to
certify all financial obligations made by the National Center
for Infectious Diseases for the remainder of the fiscal year.
--The Department's CFO also will work with Dr. Koplan to ensure that
all senior decision-makers in the National Center for
Infectious Diseases receive certified budget execution
training.
--CDC is commissioning an external review of the agency's fiscal
management practices. The review is to be completed within six
months. The results of this analysis will be communicated to
the Congress as soon as the review is complete.
--CDC program managers will conduct a top-to-bottom examination of
CDC's 133 programs and projects to make sure there are no other
areas of concern. During the 90 day period CDC managers will be
able to fully and openly identify any area for which there may
be a discrepancy between actual expenditures and the
information provided to Congress. Dr. Koplan will share these
findings with the Congress.
--CDC has commissioned Pricewaterhouse Coopers, a firm of independent
auditors, to thoroughly examine our hantavirus expenditures.
The results will be communicated to the Chairman immediately
upon completion. When this audit is complete, CDC will expand
the effort to the entire National Center for Infectious
Diseases.
In addition, Dr. Koplan has for the past year put in place numerous
corrective actions to respond to the Inspector General's report on
Chronic Fatigue Syndrome. He has implemented new financial management
systems; initiated improvements in the agency's budget displays and in
the allocation of centralized agency costs. Again, let me state very
clearly that neither any senior manager at HHS nor I have any tolerance
for inaccurate reporting and that we are all devoted to restoring the
credibility and integrity that is central to the important work done at
CDC.
Chairman Specter, Senator Harkin, and members of the Subcommittee:
I would like to thank each of you for all of the hard work you have
done to make everything we have accomplished a reality, and I look
forward to working with all of you to meet the challenges before us in
this budget. I would be happy to address any questions you may have.
DEPARTMENT OF EDUCATION
Office of the Secretary
STATEMENT OF HON. RICHARD W. RILEY, SECRETARY
Senator Specter. We now turn to the distinguished Secretary
of Education, Secretary Richard Riley, who has also served
during the entire tenure of President Clinton's Administration
starting in January of 1993.
Secretary Riley brought a wide breadth of experience to the
position, having been governor of the State of South Carolina,
a State Senator and a State representative, so that he has been
in many fields, many capacities.
He had a nationally recognized effort to improve education
in South Carolina, which led to his appointment as secretary.
He is a graduate of Furman University and a recipient of a law
degree from the University of South Carolina.
Thank you for joining us, Mr. Secretary, and we look
forward to your testimony.
Secretary Riley. Thank you so much, Mr. Chairman. I thank
you and Senator Harkin and Senators Murray and Feinstein for
the strong support of education that all four of you have shown
us. It's clear that you really believe in the investment in
young people's education and all people's education.
STATE OF AMERICAN EDUCATION
It is a great pleasure to be here with my colleagues in the
Cabinet. I just have completed my annual state of American
education address, which I gave down in Durham, NC, at a turn-
around school, a school that was predominantly African-American
and was really a school that was classified as a low-performing
school. But they had a new principal, and it was a very
exciting thing. It is now an exemplary school there in Durham.
I talked about higher expectations. I talked about the
achievement gap between the students whose families are
educated and have money and students who are minorities, and,
oftentimes, limited English proficient. I talked about the
digital gap and really those things that we can do about those.
And we are trying to close that gap. I see good things
happening. We have a lot of work to do.
The E-rate, for example, is other work that we have done in
technology. We just recently had a determination that 95
percent of our schools are connected to the Internet. And we
have gotten up to 63 percent of all classrooms connected. That
is enormous growth, and I am very proud of it.
Increased attention to early childhood programs that my
colleagues spoke about is making a real difference. Parents
have an absolute focus on keeping their children out of harm's
way and school safety is a paramount issue.
Overall, the American people have made education clearly
one of their top priorities. The budget reflects these
priorities. Turning around failing schools, school safety,
improving teacher quality, modernizing our nation's schools,
technology, safe schools, helping working and middle class
families pay for college.
The American people, I think, are getting into a new
position when it comes to how we improve education. I think
they have moved beyond the debate on Federal versus local
control. I strongly believe that State and local control, in
terms of control, must be there.
But it is so interesting to see that we have come to a new
place. The American people want practical answers. They want to
know specifics. If we are going to have national priorities,
what are they? What are our expectations? And they want
accountability for those.
They want local, State, and Federal interests working
together to create new partnerships, partnerships that are not
just government, obviously, but include business, community
groups, jump old boundaries, and make things happen. The
Federal Government is the junior partner in all of that, but a
very important partner.
THE GOOD NEWS ABOUT EDUCATION
So where are we when it comes to education? Higher
standards are now in place in all 50 States. The big job now is
to get standards down in the school classroom, where they
impact every child and have real accountability measures. We
are also starting to see the early benefits of our sustained
focus on raising standards. I think it is making a difference
in every State.
And I would like to submit for the record a new release
from the Center on Education Policy and the American Youth
Policy Forum, entitled ``Do You Know the Good News About
American Education?'' And it is, I think, a very good
indication that across the board very interesting things are
happening.
DEPARTMENT OF EDUCATION BUDGET REQUEST
But I will be the first to tell you that we still have a
very long way to go. There are schools out there that should
not even be called schools, and they need fixing immediately.
The proposed investment in this budget, I think, moves in that
direction. We are requesting $40.1 billion, an increase of $4.5
billion or 12.6 percent over the fiscal year 2000 spending.
The budget continues a strong emphasis on improving
accountability in Title I, reducing class size, improving
teacher quality, technology, modernizing our schools,
increasing after-school opportunities to help keep children out
of harm's way. And I remain very excited about the President's
college opportunity tax cut proposal. It can make a real
difference in giving young people the chance to go to college,
and middle income families as well.
TEACHER RECRUITMENT AND RETENTION
This budget includes $1 billion to support better teaching
with a strong emphasis on recruiting and retaining high-quality
teachers. There is no single way to get that job done, and we
come at it from many angles, that have been carefully thought
about.
21ST CENTURY COMMUNITY LEARNING CENTERS
One of the best ways to keep our children out of harm's way
is through positive after school experiences. That is why we
are proposing a $547 million increase for 21st Century
Community Learning Centers, doubling the funding to the total
of $1 billion, making the after-school effort very important.
SCHOOL SAFETY AND DISCIPLINE
School safety and discipline are very immediate. We do not
need another Columbine. I worry about that every single day,
and I know each of you do. And the other incidents that have
happened, even though they are very rare, are still so terribly
important. Any one of them makes it a crisis.
SMALL, SAFE AND SUCCESSFUL HIGH SCHOOLS INITIATIVE
Young people need to have a strong sense of connection. I
think that is very important, when you look at school violence.
We propose to scale up our Small, Safe and Successful High
Schools initiative by providing $120 million to help 700 high
schools create schools within schools. These are these large,
often consolidated schools.
SAFE SCHOOLS/HEALTHY STUDENTS INITIATIVE
We are now in our second year of funding for our joint
safety initiative with HHS and the Justice Department. There is
an enormous demand for this initiative. I think there is great
potential in that. It is something, Mr. Chairman, you have been
interested in. Over 440 cities applied for those grants. We
were able to grant 54 of them in the first year, to show you
how significantly it is seen by cities. We expect another 20 to
23 to be funded this year.
CHILDREN'S HEALTH INSURANCE PROGRAM
I would mention CHIP, Mr. Chairman and members of the
committee. I think all of us ought to be talking about that,
how we get young people out there to get health care. That is,
just like these other issues, an overlapping issue. But under
eligibility of Medicaid and CHIP, really every poor young
person in the country ought to be receiving health care. And
that is, too, related to these issues.
SAFE AND DRUG-FREE SCHOOLS AND COMMUNITIES
But it is important to remember that our nation's schools
still are basically safe. We have 53 million young people in
school every day. That is an awful lot of young people. Yet
less than 1 percent of the homicides among youth aged 12 to 19
occur in schools, at school functions or on the way to school,
way less than 1 percent.
Drug use is falling slightly, but remains much too high. It
is one of the reasons why we continue to work hard to improve
the effectiveness of the Safe and Drug-Free Schools program.
The budget reflects those changes. We believe that our middle
school coordinators effort can play a positive role in helping
parents and school officials who are on the front line, and I
think our effort to support character education and civic
education also help as well.
SCHOOL MODERNIZATION
I also urge the Congress to pass our school modernization
legislation. Many rural and urban school districts need the
help. Our modernization proposal now comes in two parts. And I
want to try to urge you all to take a look at that. Both are
worthy, I think, of consideration.
We are putting strong emphasis on our new $1.3 billion
appropriation for school renovation, a request to help school
districts renovate and repair thousands of old schools that are
in urgent need of repair, often in areas that cannot float a
bond issue. They really do need some special help.
Our school buildings are wearing out in many of these older
cities. They are old, overcrowded in other areas. We think that
that bears an awful lot of attention.
PELL GRANT MAXIMUM AWARD
Let me conclude by a comment on higher education. We are
proposing increasing the maximum Pell Grant to $3,500, up from
$3,300, a $200 increase, up more than 50 percent since 1994.
COLLEGE OPPORTUNITIES TAX CUT
The President's new 10-year, $30 billion College
Opportunities Tax Cut--which I would be happy to discuss in
detail, if you would like, will be of significant help to
working class families who make under $43,000 a year. It
provides special help for them, as well as middle class parents
with several children going to college with special cost
problems.
I thank you very much for giving me the chance to be here
with my colleagues. And I, like they, welcome questions. Thank
you.
PREPARED STATEMENT
Senator Specter. Thank you very much, Secretary Riley.
[The statement follows:]
Prepared Statement of Hon. Richard W. Riley
Mr. Chairman and Members of the Committee: Thank you for this
opportunity to discuss the President's fiscal year 2001 budget request
for education. I want to begin by thanking you, Mr. Chairman, as well
as other Members of this Subcommittee, for your strong and consistent
support for education over the past several years. Working together, I
believe we have made real progress in helping to expand educational
opportunity for all Americans.
The American people have made education one of their top national
priorities. We recognize that the Federal government is the junior
partner in our education system, and that real progress in improving
education depends primarily on State and local efforts. But we can play
a critical role in encouraging and supporting State and local
initiatives, particularly in the areas of raising standards, improving
accountability for results, and helping to meet the needs of
disadvantaged and limited English proficient students and students with
disabilities.
The American people also see this time of peace and prosperity as a
unique opportunity for the Nation to be investing in the long-term
future of our great country by improving education at all levels. Some
might argue that the growing Federal budget surplus should be used for
broad-based tax cuts, but that's not what I hear when I talk with
students, parents, and teachers across the country. What I hear instead
is a strong consensus on paying down the national debt and building for
the future by investing in the education of our children.
That is why the President is requesting $40.1 billion in
discretionary spending for the Department of Education, an increase of
$4.5 billion or 12.6 percent. This budget reflects the transition to
the second phase of the standards-based reform efforts we launched
seven years ago. First, we worked with the Congress to support State
and local efforts to raise standards and put accountability measures in
place. Standards are now in place in all 50 States and we are working
hard to improve accountability. Now we need to ensure that States and
communities have the resources needed to ensure that all students can
achieve to higher expectations and that teachers are prepared to teach
to the new standards.
The Department's request provides significant new resources to help
States and communities implement higher standards in their schools
while coping with booming enrollments and the need to modernize
academic facilities. The request also provides substantial new support
to help prepare disadvantaged students for postsecondary education and
make college more affordable for all Americans.
INCREASED ACCOUNTABILITY
The 2001 budget for education once again emphasizes accountability
for results, particularly for chronically failing schools. Our purpose
is not to punish the students in those schools, but to provide the
right combination of incentives and support that will accelerate the
changes needed to improve the quality of their education.
The President's request for Title I includes $250 million for a
second year of accountability grants, an increase of $116 million over
the 2000 level. These funds would enable States and school districts to
provide the additional assistance needed to help failing schools--
primarily those identified for corrective action under Title I--turn
around and improve student achievement.
The President's proposal also recognizes that in too many schools,
students and parents have waited far too long for meaningful change and
improvement. For this reason, school districts participating in Title I
would be required to offer students enrolled in a school identified for
corrective action the choice of attending another public school not
identified for corrective action. The goal here is to help ensure that
no student is trapped in a truly bad school, and to reinforce the idea
of serious consequences for schools that consistently fail to improve.
At the same time, we are emphasizing efforts to turn around poor-
performing schools, because even with a public school choice option the
majority of students will continue to attend their neighborhood school.
IMPROVING LOW-PERFORMING SCHOOLS
We want to balance accountability for meeting high standards with
new resources to help students meet those standards and to help school
districts turn around failing schools. This is why, for example, the
request includes a $547 million increase for 21st Century Community
Learning Centers, for a total of $1 billion for after-school and other
extended-learning programs. These funds would support high-quality
extended learning opportunities for nearly 2.5 million children,
including students in low-performing schools.
We also would add $450 million to reduce class size in the early
grades, for a total of $1.75 billion to help children get more personal
attention, improve discipline, and learn more. There's no better way to
rapidly improve student achievement than to put highly trained teachers
into small classrooms where they can provide the individual attention
students need to reach high standards. The request would bring the
total number of teachers hired under this program to about 49,000, or
almost halfway to the President's goal of hiring 100,000 teachers over
seven years.
One of the best ways to bring about real change and turn around
failing schools is to help communities and schools to put in place
reforms based on solid research. This is why our budget includes $190
million for the Comprehensive School Reform Demonstration program to
help an additional 1,900 schools develop and implement proven,
comprehensive reform models. We would also increase funding for
educational research by $30 million to help meet the growing need for
research-based information on what works in education.
The request also expands the Small, Safe and Successful High
Schools initiative to help create smaller, safer, and more disciplined
and supportive learning environments in approximately 700 of the
Nation's largest high schools. The President's budget would provide
$120 million for such effective innovations as schools-within-schools
or career academies that assign students to groups of a few hundred--
helping to replace the isolation many students feel in large schools
with smaller, more nurturing communities.
Another way to accelerate change is by giving parents more choices
of public schools. Our budget would increase the choices available to
parents and students through a $175 million request for Charter
Schools. These funds would support the start-up of some 1,700 new or
redesigned charter schools, which have the flexibility to offer
innovative educational programs in exchange for greater accountability
for student achievement. The 2001 request would bring to 2,400 the
number of charter schools helped by this program, supporting the
President's goal of creating 3,000 charter schools by 2002.
We also are seeking $20 million for the Opportunities to Improve
our Nation's Schools initiative, or OPTIONS. This flexible new
authority would support 40 grants to States and school districts to
implement and test new approaches to public school choice, including
inter-district programs and public schools at work sites and on college
campuses.
Our budget also acknowledges the importance of recognizing success.
A new, $50 million Recognition and Reward program would reward States
for improving student achievement and for reducing the achievement gap
between high- and low-performing students, as measured by State results
on the National Assessment of Educational Progress.
MODERNIZING OUR SCHOOLS
A key priority for 2001 is to help ensure that all students have
the opportunity to attend safe, modern school facilities that are
equipped with up-to-date educational technology. With public school
buildings averaging some 42 years of age and a backlog of more than
$100 billion in repairs, it is clear that we have a lot of work to do.
This is why the 2001 request includes two proposals to upgrade school
facilities.
The School Renovation program, a major new $1.3 billion
discretionary initiative, would help school districts repair or
renovate their schools. The $1.3 billion total includes $50 million in
grants to approximately 119 districts with at least 50 percent of their
children residing on Indian lands, $125 million in grants to high-need
school districts, and $1.125 billion that would leverage an estimated
$6.5 billion in 7-year, no-interest loans.
The School Renovation initiative would complement the President's
School Modernization Bonds proposal, which would provide nearly $25
billion in tax credit bonds over two years to modernize up to 6,000
schools. Tax credit bonds, which the President is proposing for the
third year in a row, would provide interest-free financing to help
State and local governments pay for modernizing schools and addressing
overcrowding.
An additional factor driving the demand for the upgrade of school
facilities is the explosion in the development and use of educational
technology based on multimedia computers and access to the resources of
the Internet. Computers are the ``black board and chalk'' of the
future. A key resource for this revolution in educational technology is
the E-rate, created by the Telecommunications Act of 1996, which
provides nearly $2 billion annually in subsidies to help schools and
libraries connect to the Internet.
The Department budget would provide $450 million for the Technology
Literacy Challenge Fund, an increase of $25 million, to help schools
integrate technology into the curriculum and ensure that teachers in
high-poverty communities are prepared to use educational technology
effectively. We also would double funding to $150 million for the
Preparing Tomorrow's Teachers to Use Technology program, which helps
prepare new teachers to use technology effectively to improve
instructional practices and enhance student learning in the classroom.
And to help close the digital divide in our communities between
those who enjoy the full benefits of computers and the Internet and
those economically disadvantaged individuals and families who lack
access to such technology, the budget would more than triple funding
for Community Technology Centers. The $100 million request would
support up to 1,000 new centers offering area residents access to
extended learning opportunities before and after school, adult
education, and online job databases.
MASTERING THE BASICS
The President's budget also expands support for programs that help
students master the basics and close achievement gaps between
disadvantaged and minority students and their more advantaged peers.
The request includes $8.4 billion for Title I Grants to Local
Educational Agencies and $286 million for the third year of the Reading
Excellence program, which helps all children to read well and
independently by the end of the third grade. We would increase funding
for Special Education Grants to States by $290 million for a total of
$5.3 billion, while boosting support for Special Education Parent
Information Centers by 40 percent.
Indian Education programs would receive $116 million, an increase
of 50 percent, to provide larger formula grants to school districts for
Indian Education programs, and to launch a new $5 million American
Indian Administrator Corps that would train American Indian teachers
and professionals to become school administrators.
It is difficult if not impossible to master the basics in
communities and schools threatened by youth violence. I know that
preventing youth violence is a priority shared by both President
Clinton and the Chairman of this Subcommittee. To help expand the Youth
Violence Initiative that you helped launch last year, Mr. Chairman, we
are requesting a $50 million or 25 percent increase in funding for Safe
and Drug-Free Schools National Programs. These funds would be used
primarily to make new awards under the Safe Schools/Healthy Students
initiative. This interagency initiative--funded by the Departments of
Education, Health and Human Services, Justice, and Labor--would receive
a total of $247 million in 2001, an increase of more than $100 million
over the 2000 level.
IMPROVING TEACHER QUALITY
We need to elevate the teaching profession and expand opportunities
for teachers to continually update their skills. Improving teacher
quality is a major emphasis in the Educational Excellence for All
Children Act, the Administration's proposal for reauthorizing the
Elementary and Secondary Education Act of 1965. We need to make sure
our teachers are prepared to teach to the new State standards, and we
need to help States and communities deal with the projected nationwide
shortage of 2 million teachers over the next 10 years. Our budget
provides $1 billion for a comprehensive approach to reaching these
goals, with an overall focus on preparing both new and experienced
teachers to bring high standards into the classroom.
This includes $690 million for Teaching to High Standards State
Grants, our TitleII reauthorization proposal to promote professional
development linked to State standards and assessments. A new $75
million Hometown Teachers proposal would support comprehensive
approaches to teacher recruitment and retention in high-need districts,
while a $50 million Higher Standards, Higher Pay initiative would help
high-poverty school districts attract and retain high-quality teachers
through better pay linked to a rigorous peer-review process.
To help meet the growing demand for high-quality leadership in our
school districts and schools, particularly in the area of implementing
standards-based reforms, the budget includes $40 million for a School
Leadership Initiative. This new program would fund consortia-based
efforts to provide current and prospective superintendents and
principals--particularly those serving high-poverty, low-performing
districts and schools--with the professional development opportunities
needed to help them serve as effective leaders.
The request also would provide $50 million to reward school
districts that show the largest increases in the number of teachers who
are fully certified and teaching in the field in which they are
trained, $25 million to encourage career-changing professionals to
enter the teaching ranks, and $30 million to train some 15,000 early
childhood educators and caregivers in techniques to improve early
literacy skills and prevent later reading difficulties.
In addition, the 2001 budget includes $100 million for Bilingual
Education Professional Development to help address the critical
national shortage of well-prepared bilingual and English-as-a-second-
language (ESL) teachers.
NEW PATHWAYS TO COLLEGE
A college education remains the best guarantee of success in a
rapidly changing, technology-based economy that demands critical-
thinking skills and the ability to adapt to new ways of doing business.
Postsecondary institutions are enjoying their own enrollment boom--
climbing last fall to a record 14.9 million students--but too few
disadvantaged and minority students are entering and completing
college.
To help give these students and their families new pathways to
college, the 2001 budget includes a $125 million increase for GEAR UP
to provide 1.4 million low-income elementary and secondary school
students the skills and encouragement they need to enter and succeed in
college. We also are asking for $725 million for TRIO outreach and
support services to more than 760,000 disadvantaged postsecondary
students. The TRIO request includes $35 million for a new College
Completion Challenge Grant program that would help reduce the college
dropout rate, particularly among poor and minority students. Another
pathway to college is Tech-Prep Education, which supports efforts by
partnerships of high schools, postsecondary institutions, and employers
to create comprehensive technical education programs that prepare
students for both college and high-tech careers. The 2001 budget nearly
triples Tech-Prep funding to $306 million.
MAKING COLLEGE MORE AFFORDABLE
Just as important as preparing for college is helping students and
families pay the rising costs of a postsecondary education. Over the
past six years larger Pell grants, expanded work-study opportunities,
lower borrowing costs on student loans, and Hope and Lifetime Learning
tax benefits have made college financially possible for all who
qualify.
Paying for college is still a difficult burden, however, especially
for low- and middle-income families. Our 2001 budget would help reduce
that burden. For example, we are proposing a maximum Pell Grant award
of $3,500, a $200 increase over the 2000 level. A $60 million increase
for Supplemental Educational Opportunity Grants would provide a total
of $875 million in grant assistance to an estimated 1.2 million
undergraduate students, or 64,000 more than in 2000. And a $77 million
increase for Work-Study would continue the President's commitment to
give 1 million students the opportunity to work their way through
college.
Outside the discretionary budget for postsecondary education,
President Clinton would dramatically expand tax benefits for
postsecondary education through a new College Opportunities Tax Cut.
This proposal would build on the Lifetime Learning Tax Credit to give
over 5 million families the option of taking a tax deduction or
claiming a 28 percent tax credit on up to $5,000 in annual
postsecondary education tuition and fees. The limit would rise to
$10,000 in 2003, and the Treasury Department estimates families would
save an additional $30 billion over 10 years, compared to the current
Lifetime Learning tax credit.
To increase academic opportunities for minority students and
increase their numbers in high-skill fields such as science and
engineering, the President's budget proposes $40 million for Dual-
Degree Programs for Minority-Serving Institutions. This program would
provide competitive grants to partnerships between Minority-Serving
Institutions (MSIs) and nationally recognized research universities.
Participating students would earn two degrees in five years, one from
the MSI and one from the partner institution in a field in which
minorities are underrepresented.
Finally, the President's budget targets additional funds to Latinos
as part of the Administration's Hispanic Education Action Plan. The
2001 request includes more than $800 million in increases intended to
help expand educational opportunities and improve outcomes for Latinos.
In addition to increases for programs like Title I and TRIO that serve
large numbers of Latino students, the request provides an $86 million
increase for Adult Education, most of which would be used to triple
funding for Common Ground Partnership Grants. These grants support
demonstration programs that provide immigrants and other participants
with English literacy skills, coupled with civic education and basic
skills that are necessary to effectively navigate key institutions of
American life. The budget also includes nearly a 50 percent increase
for Hispanic-Serving Institutions to support postsecondary education
institutions that serve large percentages of Latino students.
I believe this budget is a fitting start to a new century--the
Education Century--and would provide the resources needed to increase
both quality and opportunity in our education system. The 2001 request
will, as the President noted in his State of the Union address, move
the Nation ``a long way toward making sure every child starts school
ready to learn and graduates ready to succeed.''
I will be happy to answer any questions you may have about the
President's 2001 budget for education.
Senator Specter. Before proceeding to our customary 5-
minute rounds of questioning from the members, we have been
joined by the chairman of the full committee, Senator Stevens.
We would be delighted to hear from you, Mr. Chairman.
Opening Statement of Senator Ted Stevens
Senator Stevens. Well, thank you very much. I apologize for
being late. I do have a conference. I just have a very short
statement I would like to make and submit some questions for
the record, if that can be done.
I do welcome all three of you secretaries. I think it is a
very great thing that you all would come at the same time, so
we can have everyone here with responses that are of mutual
importance to all of us, I am sure.
I would like to put the full statement in the record, if I
can.
Senator Specter. Without objection, it will be.
Senator Stevens. Secretary Shalala, I want to thank you
particularly for providing Alaska some great help, particularly
in the area of combating a very high rate of fetal alcohol
syndrome and fetal alcohol effect problems in our State. Fetal
alcohol syndrome, as we all know, is estimated to cost over
$1.4 million for each person that is born with it.
And unfortunately, we have the highest level per capita in
the country. We believe it is an entirely preventable condition
and appreciate what you are doing to help us work on the
prevention side.
I also am grateful to you for your assistance in making PET
scans available to our seniors under the Medicare program. We
talked about this last week. And I understand your staff and
the Health Care Financing Administration have agreed to a
reasonable level of Medicare payment for PET scans under the
new Outpatient Hospital Payment System that is going to go into
effect in the summer. I congratulate you very much for that.
I appreciate your agency's willingness to continue working
cooperatively with the PET community on getting full, broad,
coverage for PET scans.
It is my understanding the PET community will be submitting
revised information to HCFA in the next 45 days. We will all be
following the progress on that. And hopefully we will be able
to get full approval of PET coverage by this summer.
Incidentally, in flying back from California on Sunday, I
read a whole series of new brochures that are out from across
the country on the use of PET, how we are expanding its use
into all forms of cancer, as well as the brain. I think it just
an invaluable new system of imaging and diagnosis.
I am very interested in it because of my great friend, Dr.
Michael Phelps of UCLA, who is the inventor of that. And I am
very proud of him as a friend. It has been about 20 years ago
now that I stopped off to see him at UCLA. And he gave me a
rundown of the PET scan.
I told him I was supposed to make a speech to the National
Convention of the American Legion that day. When he got through
giving me his presentation, I asked him what time it was, and
he said it was 8:00 p.m. I started at 3:00 with him, and
unfortunately missed that convention altogether, I was so
mesmerized by what he was doing. He has undoubtedly made a
significant contribution to our medical diagnostic capability.
And I do believe that it is going to be expanding in its
use, primarily because of the help you and your staff are
providing.
Importance of Technology in Education
Secretary Riley, I am also here to tell you I am
particularly pleased with your recognition of the importance of
technology in our classrooms and training teachers to
effectively use that technology.
Long-distance education
I am sure you know we are going into our State with a whole
new concept of education by distance, long-distance education.
Tele-medicine and tele-education are two very important
opportunities for our State, which is, after all, one-fifth the
size of the whole United States.
In the past, many opportunities were denied to our teachers
and students in Alaska because of the isolation of rural
communities and villages. But distance education will change
that.
Alaska and Hawaii in particular, and some of the rural
south 48 States will benefit tremendously from the new
technologies in distance education. I am very grateful to all
you for what you and your people have done working with us.
Balance budget request with resources
A word of caution, however. I am disappointed in the
President's budget request because it promises more than we can
deliver. It includes paying out monies that theoretically come
in as taxes, which have no chance of being approved.
And because of that, we are going to have a real difficulty
in maintaining our commitment to a balanced budget and our
position that we will not use the Social Security surplus in
financing the working operations of the Federal Government.
I look forward to working with the chairman, the members of
this committee, and all of you to try to come up with a
realistic spending plan for the next fiscal year that will meet
our needs and not return to the days of a heavy deficit.
PREPARED STATEMENT
Thank you very much. And I will submit the questions.
Senator Specter. Thank you, Senator Stevens.
[The statement follows:]
Prepared Statement of Senator Ted Stevens
Senator Specter, Senator Harkin, and members of the subcommittee.
I'd like to begin by thanking you, Mr. Chairman for the leadership
you have shown in working to prevent youth violence.
When we presented our fiscal year 2001 budget, I noted that the
searing images we saw last year at Columbine and other schools must
never be repeated.
If there was ever a bi-partisan issue--this is it.
That's why the President worked with Congress to establish a new
White House Council on Youth Violence to get all Federal agencies
thinking and working together to prevent youth violence.
And that's why my colleagues, Secretary Herman and Secretary Riley,
and I join you in your determination to bring to bear the resources we
need to fight this problem effectively.
At HHS, the Surgeon General is developing a Report on Youth
Violence that we hope will be completed this year.
However, this much we already know: Violence is preventable. So we
intend to find out what works. What doesn't. And then publish and
disseminate a sourcebook of best practices.
Our budget also increases the Mental Health Block Grant by $60
million--a full 17 percent.
And we're budgeting another $78 million to stop youth violence.
Now let me highlight other important features of our budget and why
we believe this budget is critical to the health and future of the
American people.
Our fiscal year 2001 budget brings us to where we should be at the
dawn of a new century: A great nation pledging allegiance to great
goals.
Those goals are: Expanded health care coverage; renewed support for
children and families; greater scientific advancement; and the creation
of a healthier America.
Our fiscal year 2001 budget brings those goals within reach--
without loosening our commitment to fiscal discipline and a balanced
budget.
This budget is about people.
It makes a record investment in health care coverage. In access.
And in quality.
Two years ago, with bipartisan support, we launched the State
Children's Health Insurance Program.
Two million children are now enrolled.
Now we want to make sure that this new program--and Medicaid--carry
millions more children, and their parents, into the safe harbor of
quality health care.
The President's FamilyCare program will do that.
Even as we expand coverage to some parents through FamilyCare, we
recognize that many low income adults work in jobs that do not offer
health insurance.
These workers frequently rely on local health institutions and
professionals who provide services at a reduced or no cost.
This year we want to increase our support for these community
service networks to $125 million--five times our investment last year.
We need to strengthen and modernize Medicare.
First and foremost that means dedicating about $300 billion of the
on-budget surplus over 10 years to extend the solvency of the Trust
Fund until 2025.
We must also add a voluntary prescription drug benefit to Medicare.
As the President said in his State of the Union, we would never
design Medicare today without a prescription drug benefit.
We can't change the past. However, we can change the future.
But, the longer we wait, the worse the problem will become--and the
more expensive it will become.
Government cannot step into the shoes of parents and communities,
but government does have a role to play in helping families balance
work and children.
One recent study notes that in 1998 only 10 percent of the 14.7
million children eligible for Federal child care subsidies received
them.
So as part of the President's Child Care Initiative, this year's
budget adds another $817 million to the Child Care Development Block
Grant.
This is part of our discretionary budget and brings the total Block
Grant to $2 billion.
Mr. Chairman, Head Start is one of the most successful bipartisan
programs our two branches of government has ever created for children.
This year we're requesting $6.3 billion for Head Start.
That's $1 billion more than last year--and the largest increase in
the history of Head Start.
I can't talk about children without talking about drugs. I know,
Mr. Chairman, that you would like to pursue this further in our
question and answer period.
We know marijuana use has leveled off among teens. But too many
teens are still saying ``yes'' to drugs and alcohol.
That's why our budget includes over $3.3 billion for substance
abuse treatment and prevention.
I mentioned the success we've had cutting the death rate from AIDS.
But HIV/AIDS is still a disease without a cure--and is still the
greatest public health challenge both here and around the world.
So fighting HIV/AIDS remains a top priority for the Department.
Our total AIDS budget this year is $9.2 billion--an increase of 8.4
percent over last year.
Every agency's AIDS-fighting budget is going up in prevention,
treatment and research.
On the prevention side, we propose to spend an additional $75
million to help stop the spread of this disease.
Specifically, the CDC will direct $40 million of the new funds to
local communities--including prevention services targeted to minority
populations.
CDC will spend another $26 million to fight AIDS around the world.
At the same time, the Health Resources and Services Administration
will expend $1.7 billion in Ryan White funding to help people living
with HIV/AIDS.
This is a $125 million increase over last year.
Our budget request for AIDS-related research at NIH is $2.1
billion, a 5.2 percent increase over last year.
The total NIH budget this year is $18.8 billion--$1 billion more
than a year ago.
This subcommittee should take pride in the unprecedented investment
we have made in basic and clinical research.
Our shared commitment to NIH, . . .
. . . and to producing quality science and scientists--on both the
NIH campus and at great research universities--is an extraordinary
legacy.
Years from now, we will see results beyond our wildest dreams.
Some of those results are certain to come from the $73 million we
intend to invest--over 2 years--to build a National Neuroscience
Research Center at NIH.
This will put all NIH brain research under one roof.
More important the Center will usher in what is certain to be The
Century of the Brain.
In the interest of time--let me quickly mention three other areas
where we intend to increase our discretionary budget.
We take very seriously the need to stop infectious diseases and
bioterrorism.
Our budget increases by almost 50 percent CDC's funding for disease
surveillance.
As for bioterrorism--which may be the biggest threat of the 21st
century--we're proposing to spend $265 million to prepare for, and
respond to, a biological attack.
We also want to make a major investment in bricks and mortar.
In addition to the Neuroscience Research Center at NIH, CDC
proposes to spend $127 million--$70 million more than last year--to
modernize and expand three laboratory sites.
The remaining funds will go toward completing the Edward R. Roybal
infectious disease lab, and construction of a new environmental health
lab.
Mr. Chairman, I want to conclude my testimony by noting that our
greatest moral imperative is to close the gaps in health outcomes
between minorities and the majority population.
In 1998, the President set a goal of ending health disparities in
six major areas.
Now, almost every operating division is working to close these
gaps.
That includes an additional $35 million at CDC for community-based
research and demonstration projects to reduce disparities.
Thank you.
TRANSPORTATION FUNDING FOR WELFARE WORKERS
Senator Specter. Secretary Herman, when you talk about
areas of needs, of trying to move workers from, say, the inner
city, where there are no jobs, to the suburbs, where there are
jobs, I think that is an area which requires special attention.
And I thank you for taking the initial steps to free $1.3
million for Philadelphia. We talked about that week before
last, and you acted on it last week. But when I visited the
transit system yesterday, I was told the check was in the mail.
Do you know how far along the delivery route that check is?
Secretary Herman. I believe it will arrive on Thursday.
Senator Specter. OK. So I will report back to them that it
is still in the mail.
That program needs a lot of additions. They transport 1,500
people in buses, and they have some 9 vans. But I am making a
survey to see how many poor people need that transportation,
what it would do for the lives of people giving them dignity
and a job, and what it would do for the taxpayers on reducing
welfare payments. So we are going to come back to you there,
but I do appreciate your help.
BIOTERRORISM
Secretary Shalala, you commented specifically about the
$265 million on bioterrorism. A commission just finished its
work a few months ago on dealing with weapons of mass
destruction. I served as vice chairman. And the commission did
not move into the domestic area. And I believe that is
something that we ought to be doing more on, this subcommittee,
and will.
But could you give us in a general way the use of the $265
million on anti-bioterrorism?
Secretary Shalala. Yes. Thank you, Mr. Chairman. As you
well know, unlike other kinds of terrorism, bioterrorism, the
response for it needs to be done on the ground in local
communities.
And, much of this money is focused on building up the
public health infrastructure and educating the medical
community, both in terms of identifying what may turn out to be
a release of some kind of disease and reporting it as quickly
as possible.
So what we do on the ground level is strengthen the
existing public health infrastructure and the State and
community public health officials that are responsible. And,
simultaneously strengthen our surveillance systems, which were
set up originally for infectious diseases, but now are full
reporting systems for any kind of outbreaks, which are reported
from the community, State, and then to the CDC, and our
response time in our laboratory capacities across the country
in being able to make a diagnosis quickly.
Senator Specter. Could you give me your evaluation as to
the adequacy of our domestic program against potential
bioterrorism?
Secretary Shalala. The current program is inadequate. And
that is the reason for these substantial investments at both
the local level, the State level, as well as the national
level.
Senator Specter. I would like to work with you on the staff
level. I do not want to cut you short, but I want to come to a
couple more questions.
Secretary Shalala. We would be happy to do that. The person
who is coordinating it in the Department, I want to point out,
is the Assistant Secretary for Planning and Evaluation, Peggy
Hamburg, who is a physician and the former New York City health
commissioner.
Senator Specter. That is a good start.
Secretary Shalala. We particularly picked someone who
actually knows what you do on the ground and how you can
strengthen the system from the bottom up.
MEETING DIVERSE NEEDS OF SCHOOL DISTRICTS
Senator Specter. Secretary Riley, last year we had a real
battle over the potential for local flexibility on the issue of
providing additional teachers. And the question which I would
like you to provide for the record, because I want to ask
another question before my red light goes on, I intend to
observe it, is what is the disadvantage of allowing a school
board to go for books or computers or some other facet, instead
of hiring teachers to reduce class size?
PREVENTION OF UOUTH VIOLENCE
But the question I want to get a response from all three of
you secretaries on is, our program against youth violence has
looked at existing resources on the National Institute of
Mental Health and Center for Disease Control, the parenting
initiatives, et cetera.
MASS MEDIA ENTERTAINMENT AND YOUTH VIOLENCE
But what about the role of movies and television and the
computer and video games? And we do not want to point fingers,
as many have, there specifically. But to what extent should we
look at that? Considering the first amendment rights and
freedom of speech, how big a problem is it? And what are your
suggestions as to what we ought to be doing there? May we just
work through the panel?
Secretary Riley, why do you not start?
Secretary Riley. Well, when you have the distribution
system this country has, the capacity to deliver and the amount
and availability of information that we have now--and we have
really only scratched the surface, you then are going to have
considerable issues to deal with. And that is the availability
of undesirable information and so forth to youngsters.
And I emphasize the important role that parents and
teachers play in that. I think no matter how many filters you
have, how much you try to deal with that--I was in the mine
force in the Navy, and we were always talking about measures
and countermeasures. And you get a countermeasure for filtering
out something, and then they develop a measure to produce it in
a different way.
So I think you can have all of that, and it is a help. But
really, it falls back on, I think, parents working with young
people, making sure that the availability and the use of these
powerful tools is supervised and managed.
And the same applies with teachers in schools. Schools can
do a better job than families, because they have the constant
supervision of computers and other information. So I think it
is a combination of things. All of these technical things are
important. But really, it falls back on quality teachers and
quality parents.
Senator Specter. I am going to come back to this question
in the second round, because we have quite a large attendance.
And I do not want to exceed the 5-minute rule here.
Senator Harkin.
PENSIONS PAID VIA LUMP SUM VS. ANNUITY
Senator Harkin. Thank you very much, Mr. Chairman.
Secretary Herman, I sent you a letter on January 28
discussing what appears to be an increasingly common, but
unfortunate, practice concerning pensions. What is happening is
that many major companies offer employees retiring early the
option of taking their pension benefits as a lump sum. ERISA
requires that all defined benefit plans must pay benefits as an
annuity, must pay it as an annuity, unless the employee and his
or her spouse knowingly agrees to waive the annuity form.
Although the statutes and regulations require the plan
fiduciary to disclose the ``relative value'' of the optional
forms of a benefit, a growing number of these employers not
only fail to disclose, some, I think, even try to hide the fact
that the lump sum has a value far less than the annuity. I
think this represents a clear violation of the specific ERISA
statutes and regulations, as well as an employer's general
fiduciary responsibility.
Have you looked into this? And are you proposing any plans
to stop this kind of an abusive practice?
Secretary Herman. Senator, we are looking very carefully
into it. And I certainly appreciate the concern and the
interest that you have taken in particular in this issue,
because what it really boils down to is the ability of
beneficiaries, of participants, to make informed judgements and
their right to know. It is not necessarily the quantity of the
information, but it is about the quality of the information
that is needed to make critical retirement decisions.
And we want to continue to work with you and others in
efforts to advance the whole education effort to ensure, first
of all, that plan participants are getting the information that
they need to make informed decisions about their own
retirement.
But additionally, as your letter points out, we are also
working with Treasury, and the IRS, to look at what formal
steps we may need to take in this area regarding the specific
obligations of ERISA. And I will be sure to have a written
response to your letter in the very near future.
CDC'S BUILDINGS AND FACILITIES
Senator Harkin. I appreciate that, and I appreciate your
attention to this. And one of the examples I used in my letter,
the annuity option had an actuarial value 80 percent larger
than the lump sum. And yet, the information that was given to
the employee did not point that out at all.
And, of course, you hold out a lump sum and tell them they
can invest in the stock market and they can make all this fast
money and stuff. It looks very nice. But really what is
happening is, basically the employer is buying back the annuity
at a very reduced rate.
So I encourage you to pursue this vigorously, and I am sure
that you will.
Secretary Shalala, recently I visited the Center for
Disease Control in Atlanta. And I have to tell you, I was
shocked at the condition of the facility at the world's premier
disease control center, the one that people around the world
look to for the prevention of outbreaks, the rapid response to
the various diseases and viruses that are coming out. I
understand just in the last 20 years 35 newly emerging diseases
have been identified and are becoming virulent.
I remember when Senator Hatfield left the Senate. He spoke
on the Senate floor about the fact that with the Cold War over,
it is no longer the Russians are coming, but the viruses are
coming. And he spoke about the need to invest more basically in
NIH.
I think we have focused a lot on NIH. You have, to your
great credit, we have on this committee, to the chairman's
credit, focused on doubling NIH research. He has been a great
leader in that. I wonder if maybe we have not somehow kind of
shortchanged the Center for Disease Control. I remember the
movie Outbreak with Dustin Hoffman in it. I always assumed it
was filmed there.
Senator Harkin. That is sort of what I assumed. I get down
there and find out that the movie producers came down there and
looked at CDC and, as I understand it, refused to film it there
because no one would believe how bad it was. So they went to
Hollywood and built their own set. So what you see in the movie
was not the actual Center for Disease Control.
Now I know they have a proposal in for new buildings. And I
must say that the time frame is too long. I think somehow we
have to collapse that time frame. I am just shocked. I do not
know why I had not really paid more attention to this myself in
the past. I think perhaps a lot of focused on NIH and the basic
research.
But when you are talking about these newly emerging viruses
and diseases and outbreaks of food-borne illnesses, I mean,
this is where we look worldwide for rapid intervention.
So I just--and I have to believe that it makes it more
difficult to recruit scientists, too, when they go down and
take a look at that place. Who wants to work there? I mean, it
really is bad. I know you know that. I mean, you have been
there.
But I am just wondering for your response, just a general
response, on the conditions and whether you think we should be
pushing a little bit harder and faster on the buildings and
renovation of CDC than what we are doing.
Secretary Shalala. Senator Harkin, I welcome the
opportunity to talk to you about that. I do not disagree with
your comments. In fact, this year's budget has 122-percent
increase in our request for construction money. It is part of a
master plan.
What I would like to do is to work with the committee and
identify and show you what we have done in a master plan. If
you would like to shorten the amount of time, we would
certainly be prepared to talk to you. But we have now laid out
a master plan.
This may be a case of a little out of sight, out of mind.
And, we need to pay attention. The focus on CDC, in this
budget, is my personal highest priority. As I am ending my tour
of duty in government and since I spent much of my career
working with State governments, we could figure out how to
finance capital projects.
We have to do it out of every year's budget, as opposed to
stretching it out over time. And the budget rules are just
irresponsible, in my judgment, about the financing of capital
projects. We have to put everything in the budget in 1 year----
Senator Harkin. Crazy.
Secretary Shalala [continuing]. As opposed to spreading it
over time. And we need to work through these issues when we are
investing in institutions as important as the CDC or the NIH or
any of the other institutions where we have to build
facilities.
FDA also has a proposal here. It has been just as difficult
to struggle to make sure that FDA has first-class facilities,
because of the way the budgeting rules work, and not our lack
of interest or attention to the structures that we think are so
responsible and important to the quality of work.
Senator Harkin. Thank you.
Senator Specter. Thank you, Senator Harkin.
Senator Feinstein.
CLINICAL TRIALS DATA BASE
Senator Feinstein. Thanks very much, Mr. Chairman.
I want to compliment the three of you on your
presentations. I thought they were excellent. With your
permission, Mr. Chairman, I will submit a statement for the
record.
[The statement follows:]
Prepared Statement of Senator Dianne Feinstein
Thank you to all of you for coming before our subcommittee today.
You are responsible for addressing some of the nation's most pressing
problems. Let me name a few that face my state, the largest state in
the nation, 34 million people.
EDUCATION
California's needs
Our nation's schools face huge challenges--low test scores, crowded
classrooms, teacher shortages, booming enrollments, decrepit buildings.
--California has 5.8 million students, more students than 36 states
have in total population and one of the highest projected
enrollments in the US.
--California will need 300,000 new teachers by 2010. Eleven percent
or 30,000 of our 285,000 teachers are on emergency credentials.
--California has 40 percent of nation's immigrants; we have 50
languages in some schools.
--For school construction, modernization and deferred maintenance,
California needs $21 billion by 2003 or 7 new classrooms per
day. Two million California children go to school today in
86,000 portable classrooms.
--California's Head Start programs serve only 13 percent of eligible
children.
--For higher education, the University of California has the most
diverse student body in the US. Federal programs provide nearly
55 percent of all student financial aid funding that UC
students received. Our colleges and universities are facing
``Tidal Wave II,'' the demographic bulge created by children of
the baby boomers who will inundate California's colleges and
universities between 2000 and 2010 because the number of high
school graduates will jump 30 percent.
So our needs are huge.
Fiscal year 2001 education budget
While these needs cry out for resources, the federal share of
elementary secondary education funding has declined from 14 percent in
1980 to 6 percent in 1999. Funding is so short in my state that
California teachers are spending around $1,000 a year out of their own
pockets to pay for books, magic markers, scissors and other school
supplies, according to the San Diego Tribune, August 16, 1999.
I commend the Administration for proposing to increase education
funding in fiscal year 2001 to $40.1 billion or 12.6 percent. I welcome
this increase. I hope we can do better because the status quo in
American public education is not enough.
I would like to share with you, Secretary Riley, some of my
concerns:
Title I: For the Title I program, I have two concerns: First is the
``hold harmless'' provision. Thank you, Secretary Riley, for opposing
the Title I ``hold harmless'' provision that has been included in our
appropriations bills. I hope you will more actively work to prevent its
enactment again.
In 1994, Congress included in the Title I law a requirement that
you annually update the number of poor children so that the allocation
of funds would truly reflect the most up-to-date number of poor
children. This is a very important provision to growing states like
mine. However, despite my opposition, the hold harmless provision has
been included in annual appropriations bills, effectively overriding
the census update requirement and locking in historic funding amounts
for states despite the change in the number of poor children.
Secretary Riley, I whole-heartedly agree with your statement last
year--which I hope you will reaffirm today--that ``a basic principle in
targeting should be to drive funds to where the poor children are, not
to where they were a decade ago.''
With 18 percent of the country's Title I students, California only
receives 11.4 percent of Title I funds. Please join me in vigorously
fighting the hold harmless provision. At least, 775,000 eligible Title
I students are not getting services in my state.
Second, on Title I, I hope we can work together to better focus the
funding on academic achievement. Title I reaches virtually every school
district and can be an important force for change. I hope you will give
me your thoughts on how to put more ``academic teeth'' into Title I.
Head Start
Head Start is one of the most important federal programs because it
has the potential to reach children early in their formative years when
their cognitive skills are developing. Many studies have confirmed the
significance of bringing positive influences to early brain
development. But we know that poor children disproportionately start
school behind their peers--they are less likely to count to 10 or to
recite the alphabet. Every child deserves not just a good start, but a
head start.
And yet, ``Head Start has only vague performance standards and no
curriculum to stimulate the growth of literacy and numeracy,'' say
Henry Aaron and Robert Reschaeur in Setting National Priorities, The
2000 Election and Beyond. Research tells us that for every dollar
invested, we save $7.00 in decreased expenditures for compensatory
education, crime and welfare. I hope that both you Secretary Riley and
Secretary Shalala will discuss the plight and challenges of Head Start
with me. I will have some very specific questions to pose to you.
The proposed addition of $1 billion for HeadStart to enroll 1
million more children by 2002, a 19 percent increase, is good first
step. California has 764,462 poor children age 5 and under in poverty,
but we only serving only 13 percent of eligible children. We must do
better. I want to explore with you the challenge of major reform of the
Head Start program to better prepare children for school at a time when
high quality preschool programs can have long lasting benefits.
Impact aid
I am disappointed in your impact aid request. You are proposing to
cut Impact Aid from $906.5 million in fiscal year 2000 to $770 million
in 2001.
California has 119 school districts receiving Impact Aid, helping 1
million students. In fiscal year 2000, California is receiving $57
million in Impact Aid. In California, Impact Aid funds only 23 percent
of the cost of educating a federally-connected student. This is an
important program in a state that has many tax-exempt federal
properties.
Immigrant education
I am disappointed that your budget request proposes flat funding--
no increase--for immigrant education. Appropriations were $150 million
in 1998, $150 million in 1999, and $150 million in 2000 and you have
requested $150 million.
California receives $180.00 for each eligible immigrant child which
hardly begins to address the needs these children bring to the
classroom. These are the most at-risk of all children. They speak
another language; their schooling has been interrupted and they have
huge adjustment challenges. Can't we do better?
Other education challenges
I commend the President's initiatives on school construction, both
the tax credits for bondholders and the new school renovation grants.
These are long overdue.
The continued drive to hire teachers and reduce class sizes is
right on target. California started reducing class sizes in grades K-3
in the 1996-1997 school year. We had then and we still have some of the
largest class sizes in the country. And every parent knows that the
smaller the class the more individualized attention students receive
and the more effective the teacher can be.
CHILD CARE
Secretary Shalala, I am so pleased to see that the Administration
has recommended $818 million for the Child Care Development Block
Grant. As you know, Senators Dodd and Jeffords offered an amendment
last year to increase funding to assist working families with the costs
of child care. The Dodd-Jeffords amendment doubled the discretionary
funding for the CCDBG by $818 million to a total of $2 billion. The
amendment passed 41-54, but was dropped in conference with the House
and was not included in the final version of the bill. I understand
that Senator Specter has committed to including the increased funding
in his chairman's mark for fiscal year 2001 appropriations. I am hoping
these funds will not be forward funded this year, as in previous years.
HEALTH CARE
Now I will turn to health care, another important concern of
Californians.
California's needs
We have an uninsured rate of 24 percent (7.3 million people), far
above the national rate of 17 percent. Despite a thriving economy, the
number of Californians without health insurance grows by 23,000 per
month, far exceeding the national rate.
California has the second highest incidence of HIV/AIDS in the
US.While the AIDS death rate has declined, it is till too high; 40,000
new infections develop each year. In California, 100,000 people are
living with HIV/AIDS. Nationally, half of all HIV-infected people do
not receive regular medical care (Rand study, December 1998).
California ranks 37th overall among states having children
immunized by the age of 18 to 24 months.
In my state, 37 hospitals have closed since 1996 and 15 percent
more may close by 2005. Over half my state's hospitals are losing
money. Seismic safety requirements add more cost strains.
Health budget
NATIONAL INSTITUTES OF HEALTH
While I welcome the $1 billion or 5.6 percent increase, I am told
that to keep us on the path toward doubling NIH over five years, the
increase should be $2.7 billion. Even though Congress has given NIH
generous increases in the last two years, NIH is 1999 could still only
fund 32 percent of grant proposals.
Our investment in biomedical research has given us longer lives,
healthier lives, and cures and new treatments.
This is an area of governmental activity that Americans
overwhelmingly support. Fifty-five percent of Californians said they
would pay more in taxes for more medical research
Cancer
The President proposed only a 5.9 percent increase for cancer
research.
Cancer is a concern of virtually every American. Fifty percent of
Americans have had someone close them die from cancer.
The American Cancer Society and other major cancer groups are
calling for a 15 percent increase for the National Cancer Institute,
raising NCI from $3.25 billion to $4.1 billion.
The Cancer March, that came to Washington in September 1999, called
for increasing the National Cancer Institute budget by 20 percent each
year for 4 years, to get to $10 billion by 2005. They cited the
impending ``cancer explosion,'' coming with the aging of the American
population. Because of the aging of the population, the incidence of
cancer will reach staggering proportions by 2010, with a 29 percent
increase in incidence and a 25 percent increase in deaths, at a cost of
over $200 billion per year. The cancer burden will balloon especially
in the next 10 to 25 years as the country's demographics change.
Why invest more in cancer research? The Cancer March Research Task
Force said we could reduce cancer deaths from 25 to 40 percent over the
next 20 year period, saving 150,000 to 225,000 lives each year. Other
areas that could be enhanced are bringing new cancer drugs from the
laboratory to clinical trials; continuing to identify genes involved in
cancer; improving our understanding of the interaction between genes
and environmental exposures; finding new ways to detect cancers earlier
when they are small, not invasive and more easily treated.
We must also improve participation in cancer clinical trials.
Medicare beneficiaries account for more than 50 percent of all cancer
diagnoses and 60 percent of all cancer deaths, but only two percent
participate in clinical trials.
Along this line, I hope Secretary Shalala can tell us today that
the clinical trials database that we enacted in 1997 is all ready to
go. This is an important 1-800 number for patients and doctors to find
out what research trials for serious and life-threatening diseases are
underway.
Cancer prevention is another area that needs increased resources.
The American Cancer Society says that 60 to 70 percent of all cancers
are preventable. We need to do more in this area so that Americans
never get cancer.
Other health programs
I welcome the President's initiatives to fill in some of the gaps
in health care--new initiatives like expanding the CHIP program to
children's parents; strengthening enrollment in CHIP through schools
and child care centers; increasing funding for community health
centers; restoring Medicaid to immigrant children who entered the U. S.
after August 1996 and to legal immigrant pregnant women; increases for
immunizations; for HIV/AIDs services. All of these are very important
to my state.
I do have to question why the HHS budget cuts funding to train
health professionals by $84 million. Almost one in five Californians
lives in a health professions shortage area. We are facing a nursing
shortage and will need 43,000 more nurses by 2010, which is a
conservative estimate based on a projected 23 percent increase in the
state's population.
Even though we have a booming economy, we are faced with many
challenges to which your budgets respond. I look forward to working
with you to craft a final bill that responds to these concerns that I
have outlined.
I am also concerned about the delay in establishing the clinical
trials database. We passed the FDA bill requiring NIH to set up a toll-
free 1-800 number in 1997. We created it at the suggestion of patients
and their doctors who said they need one simple place to go to find out
what research trials were being conducted. I am quite concerned that,
two and a half years later, this still not be set up and announced. I
hope you will have good news today, Secretary Shalala.
Thank you again for coming before our subcommittee.
Senator Feinstein. Secretary Shalala, it is my
understanding that last night your department announced that
you are implementing the clinical trials database Senator Snowe
and I authored. Will it now be possible for an individual to
call a 1-800 number and get information about clinical trials
relating to acute diseases?
Secretary Shalala. More important than just the 1-800
number, they will be able to go on the website, get information
about individual clinical trials, and find out who to contact
about that particular clinical trial. So it is a very
transparent system on clinical trials. I think the first 4,000
are up and on the website.
So from our point of view, your initiative and our ability
to get this up on the website so that people find out what the
clinical trial is doing, how to enroll, and specifically who to
call, this is a major step forward in health in this country.
Senator Feinstein. Well, thank you very much.
Secretary Shalala. And thank you for your leadership.
HEAD START
Senator Feinstein. Well, Senator Snowe and I appreciate
that very much. Thank you.
Let me just share with you some of my thinking about Head
Start. I appreciate very much that there is an additional $1
billion to expand the program by about 17 percent. I am coming
to question whether we should expand the program prior to the
time we make Head Start truly a Head Start program. I am
finding that many Head Start classrooms do not teach any
cognitive skills whatsoever.
I am also finding that the standards are vague and that
Head Start is a missed opportunity. One of the major cities in
California has just told me they can only pay $22,000 a year
for a Head Start teacher. You are not going to get a Head Start
teacher that is going to bring about any quality education for
that.
And then I took a look at the French system, looked a
little bit about what the Core Knowledge Foundation is doing in
setting up some model Head Start programs. I really think we
are missing the boat by expanding Head Start without improving
the quality of the program first.
And since this is a 100-percent federally funded program,
it seems to me that not only do we miss the boat, but we have
an obligation to see that standards and quality are present. I
think there is enough information. Cognitive learning is quite
possible in children of a Head Start age.
My questions are these, and I will just ask them, and then
perhaps you can respond: What is HHS doing to move Head Start
from custodial child care to a program that stresses cognitive
development and learning?
Second, would HHS be opposed to changing the focus of the
Head Start program so that more attention is placed on the
development of cognitive skills?
Third, what kind of coordination or communication does the
Department of Education have with HHS on this program?
And finally, should we not really move Head Start to the
Department of Education and convert it into a strong preschool
program and focus on cognitive development?
COGNITIVE SKILLS AND STANDARDS IN HEAD START
Secretary Shalala. Let me answer those questions quickly.
The answer is that Head Start is the strongest preschool
program that we have in this country. Over the last 7 years
this administration has invested substantially in improving not
only the cognitive learning part of the program, but in raising
the standards. In fact, 25 percent of all the new money going
into Head Start has been invested specifically in raising the
quality of the program.
So tough have we been on this program that we have closed
over 150 Head Start programs that did not meet our standards.
No other government program has been as effective in both
raising standards and closing down programs that did not meet
our standards.
Before we came into this administration, not one Head Start
program had ever been closed for not meeting its standards in
the history of its program.
The difference between Head Start and other kinds of
custodial programs is in fact its investment in training and in
specific standards. In fact, the specific rules of Head Start,
are much more detailed than other programs.
I would be happy to talk to you at some length about the
cognitive part of Head Start. But the genius of Head Start is
that it is comprehensive. It integrates both health, social
services, education and learning.
CUSTOMER SATISFACTION IN HEAD START
The evaluations of the program have concluded that it is a
stronger program than any other preschool programs in this
country. And parents' satisfaction of this program is the
highest of any government agency or government program that we
have. It is even higher than the ratings for Mercedes and BMW
in customer satisfaction of the program.
SHOULD HEAD START BE TRANSFERRED FROM HHS TO ED?
Do I think it should be transferred to Education? I do not.
But let me tell you specifically why. First, the history of
Head Start is a history of a program that was started because
of what was perceived as the weakness in the education programs
in this country, a lack of parental involvement. However, we
have built a series of partnerships with the Department of
Education.
And increasingly there are incentives in Head Start for
public schools to integrate Head Start programs with their
other preschool programs, their kindergarten programs. So there
is a seamless program.
But evaluations have shown something very interesting. And
that is, where Head Start programs are standalone, there is
more parental involvement than in these new cooperative
endeavors with public schools. That is, you get less parental
integration into the program when there is a cooperative
agreement with a public school than you do with standalone
programs.
That means we see ourselves as reformers of the role of
public schools and of public education. And no one has been a
stronger supporter in HHS than I have been of public education
in this country.
But it is a different kind of program of the highest
quality that has played an important role, I believe, in our
understanding of preschool education and its quality by any
measure.
If you trotted out here the world's greatest experts on
early childhood education, including the experts from the Yale
Study Center, they would say to you, this program has gone
through a transformation over the last 7 years, that it is
strong both cognitively in terms of what it teaches and in the
way it is managed and the way programs are integrated.
So we started out with an overall assessment by experts in
the field. They told us what to do. We have incorporated those.
We have invested this money heavily in improving the quality,
teacher training, and all the other parts of the program.
But simultaneously, we have kept the heart of the program.
And that is integrating parents into the learning process for
these young people.
Senator Specter. Secretary Shalala, you are on a very big
subject. Could you supplement your answer for the record?
Secretary Shalala. I will, yes.
Senator Specter. Because we are pretty much over time.
Secretary Shalala. With both the data and the research. And
I would be happy to look at any California programs that my
good friend, the Senator from California, thinks are weak in
particular. And I would be happy to have our teams look at them
very carefully.
Senator Feinstein. Mr. Chairman, would it be possible to
ask Secretary Riley to respond to that as well?
Senator Specter. Well----
Secretary Riley. How about in writing?
Senator Feinstein. In writing?
Senator Specter [continuing]. If you can briefly.
Senator Feinstein. In writing would be fine.
Senator Specter. If you can briefly respond orally, and
supplement it, Mr. Secretary, in writing, because we do have
other Senators who are waiting.
FOCUS ON COGNITIVE SKILLS IN EARLY CHILDHOOD
Secretary Riley. Very briefly, I want to thank Secretary
Shalala for really honing in during the reauthorization of Head
Start a couple years ago and all the work that has been done
since in centering on standards and quality.
I think the question, Senator, is the cognitive skills for
early childhood, which, as you point out and as Secretary
Shalala has pointed out, have gotten more attention with all
the brain research and so forth. The question is, are they
provided, and not how and where.
I am not into the empire building of the Department of
Education. I am interested in cognitive skills being there in
Head Start. And as I read it, they are very strong. That is a
very strong focus from HHS now, and they really are trying to
move in that direction as rapidly as possible and are doing a
grand job moving in that direction.
HHS AND EDUCATION COORDINATION ON HEAD START
We are working closely with them, with the overlap of Title
I. The flexibility of Title I enables school districts to use
Title I for early childhood. And so we are seeing more and more
of that, and we are working very well in a cooperative way.
[The information follows:]
HEAD START
Head Start is America's premiere early childhood education program,
and continues to lead the way in state-of-the-art approaches to
enhancing young children's development. Head Start's performance
standards are, in fact, quite comprehensive and clearly delineate what
programs must do in serving children and families. These standards
cover the areas of Education and Early Childhood Development, Child
Health, Child Mental Health, Child Nutrition, Family Partnerships,
Community Partnerships and Program Governance, among others. A copy of
these standards is attached. Furthermore, it should be noted that the
Performance Standard on Education and Early Childhood Development
clearly requires that all programs must, in collaboration with Head
Start parents, implement a curriculum and goes on to discuss what this
curriculum must include.
This Administration has invested heavily in improving not only the
cognitive learning aspects of this program, but in raising its
standards. We have paired investment in critical elements of quality
such as teacher compensation and training with a tough approach to
enforcement of high standards in every Head Start program. Annual
salaries for Head Start teachers have increased from $14,600 in 1992 to
$20,700 this year. Since 1995, more than 140 local grantees have been
replaced because they have been unable to rectify deficiencies in
program quality. We will continue these investments in fiscal year 2001
and will devote more than half of all new Head Start money to continued
improvements in the quality of the program.
In addition, Head Start has made a commitment to measuring child
outcomes, including cognitive outcomes as well as other key aspects of
children's development and parental involvement. Our research shows
that typical children leave Head Start with a wide range of specific
knowledge and skills that prepare them for kindergarten. These
practical, common sense achievements form the foundation for continued
progress in learning by Head Start children in kindergarten where they
show statistically significant growth in vocabulary, letter
recognition, writing and other pre-reading skills.
Head Start provides top-quality early childhood education along
with comprehensive services, such as health, nutrition, and family
support services, to almost 900,000 low-income, preschool children and
their families across the nation, including more than 81,000 children
and their families in California.
Head Start currently places a strong emphasis on cognitive skills.
Preliminary results from the Family and Child Experiences Survey
(FACES) indicate that average program quality is in the ``good'' to
``excellent'' range and no classroom scored below the ``minimal
quality'' range. Head Start children are ready for school, performing
above the levels expected for children from low-income families who
have not attended center-based programs. The survey also found that 66
percent of Head Start parents read to their child three or more times a
week and that 70-90 percent of parents teach their children letters,
numbers or songs.
We are building upon this progress with new initiatives, including
expanded training in family literacy services, new partnerships with
pre-kindergarten and child care programs, and the development of local
grantee systems to track and analyze child outcome data.
The Head Start Bureau has extensive collaborative relationships and
initiatives with the Department of Education, including the following:
--Recent joint sponsorship with Title I, Even Start, and HHS's Child
Care Bureau of a national leadership forum of State leaders and
managers of pre-kindergarten, Head Start, and child care
programs to explore new opportunities to use State and Federal
early childhood funding to reach more children with higher
quality services and to identify ways to eliminate barriers to
cross-program collaboration.
--Long-standing involvement with ED in joint efforts to serve
infants, toddlers, and young children with disabilities,
including participation in the Federal Interagency Coordinating
Council, and public-private partnerships such as the Conrad
Hilton Foundation/Head Start $15 million initiative to training
community teams of Early Head Start, ED early intervention
program providers, parents and other community agency leaders
to improve serving to infants and toddlers with disabilities.
--Collaborative efforts in research and accountability efforts,
including joint sponsorship and funding of major longitudinal
studies of early childhood development (including the National
Center for Education Statistic's Early Childhood Longitudinal
Survey, Kindergarten & Birth Cohorts) and emerging efforts in
Title I and Even Start to utilize the Head Start Performance
Measures outcome measures in Federal evaluations and State-
level accountability efforts.
--Additional leadership efforts between Head Start and public
education programs and systems occur at the State and local
level through the nationwide network of Head Start-State
Collaboration Offices which give priority attention to forging
linkages among local Head Start agencies, family literacy
initiatives, State pre-kindergarten programs, and local
education agencies.
--Finally, and most importantly, every local Head Start grantee is
held accountable for maintaining strong and effective
partnerships with local elementary schools and districts
through specific mandates covering the provision of family
literacy and adult education services, services to children
with disabilities, and preparing every child and family for a
successful transition to kindergarten.
Senator Specter. Mr. Secretary, thank you for that
amplification.
HEAD START STAFF SALARY LEVELS
Senator Harkin. If I might just say one thing to my friend
from California. You are not going to get good cognitive skills
teaching to the point that we want in Head Start if you are
going to keep paying Head Start teachers as babysitters.
Secretary Riley. That is true.
Senator Harkin. If you are going to pay them at the rate of
babysitters, that is what you are going to get. Now if you want
to start getting cognitive skills--the big scam on Head Start
is what we are not paying the Head Start teachers.
Senator Specter. Secretary Shalala and Secretary Riley,
Senator Feinstein raises a very important question. And we have
been in conference on these figures, debating precisely the
issues which both Senator Feinstein and Senator Harkin have
raised.
If you would--I think this is something we ought to pursue
at the staff level. This may even be a subject for a full blown
hearing. But let us pursue it at the staff level. And if you
could supplement your verbal answers in writing, we would
appreciate it.
Senator Murray.
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Thank you very much, Mr. Chairman. And
thank you to all three of the cabinet members who are here
today, and I just personally thank you for all the work you
have done on behalf of so many children and families in this
country in your service. And I really do appreciate it.
CLASS SIZE REDUCTION FUNDING
Secretary Riley, let me begin with you. The chairman asked
you a question and a response in writing, but I really would
like to hear your opinion on the debate that we continue to
have on whether or not to focus targeted money on reducing our
class sizes by hiring additional teachers or whether or not
just sending that money out to schools to allow them to
purchase books or pencils or paper or computers or whatever
their needs are.
I do not think there is any doubt in anybody's mind that
there are tremendous needs in our public schools for those
kinds of things. But what are the advantages of targeting it
directly to hiring additional teachers?
ROLE OF FEDERAL EDUCATION PROGRAMS
Secretary Riley. Well, of course I look at the Federal role
as being one of support of the States and local schools, but
with a national identification of a priority and a targeted
effort. That is how Federal programs are most effective, and
that is the role as I see it.
CLASS SIZE REDUCTION--USE OF PROGRAM FUNDS
We have as a goal for this Nation to get the class size of
early grades down to 15 to 18 pupils per teacher--and the
research shows that that works. It works in those grades. It
works in the eighth grade, in the twelfth grade, and on into
college. It makes a difference in a child's education.
So by setting the national goal to do that--to reduce class
size, and that is a proposal that you have strongly supported,
then we have to move in that direction. If you then lump that
in with a block grant kind of approach, what you do is you take
your eye off the prize.
You take your eye off the focus, your eye off the national
goal in this country of saying that all children will have a
relatively small classroom in those early grades with a teacher
well qualified to teach reading.
So I am very much in opposition to lumping national goals,
national focus, in with a number of other things. You have no
way for accountability. There is no way you can look at how
well it is working, if people have all kinds of options.
Now I think within a program, there should be enormous
flexibility. In the Federal Government, of course, under the
proposal that you and I have supported, they do not pick the
teachers, they do not decide what classes to do what in. It
simply is a Federal priority targeted for that direction. And
that is what makes a difference. And you can look at it in the
future, see if it's working, or if it is not, determine why.
CLASS SIZE AND SCHOOL VIOLENCE
Senator Murray. Thank you very much, Mr. Secretary. And the
chairman asked about this issue of school violence. In talking
to the teachers who are now in classes of 15 or 16, they tell
me specifically that they now can focus attention on young kids
and have them have that adult-child relationship that they
believe will make a difference on the issue of violence later
on.
So if we do have that targeted approach, we will be able to
follow that more closely. And I appreciate your response.
EDUCATIONAL TRAINING AND WELFARE RECIPIENTS
Secretary Shalala, I have a question for you. I am hearing
a lot of anecdotal evidence in my State and elsewhere that many
of the community college programs that typically were filled
with returning welfare-to-work mothers, nursing programs,
things like that, are empty this year. Enrollments are way
down. And a concern that because education is no longer
considered a--that you need education as part of your welfare,
that we have lost a lot of those moms, young moms, either back
home in perhaps an abusive situation that they cannot get out
of or in jobs that are going to go nowhere.
Are you hearing this at your level as well? And I really
would like to hear from Secretary Herman and even Secretary
Riley on this, because both of you mentioned the disparity in
people who are able to go to college and in the disparity in
the workforce between those who are able to get into higher
paying jobs and not.
And I am worried about this component of those welfare-to-
work moms, if they are not getting into programs in our
colleges that will help them get into those higher paid jobs.
Secretary Shalala. Senator Murray, when the welfare bill
was written, it left to the States the decision about whether
full-time college attendance could be integrated, and you would
not lose the 2-year time frame. So those decisions were left to
the State, as opposed to something that was automatic.
The vast majority of college students in this country are
now going part time. That is, they are working and going to
school. And while that is a particularly heavy burden for young
moms and for people coming from welfare to work, the fact is
that in their own neighborhoods, in the houses next to them,
are people who are combining work and going to school.
And I just think the States have struggled with this issue.
Is it fair to allow a small group of people, because they came
through the welfare system, to go to school full time and be
subsidized by the welfare system as an investment in their
long-term earning potential versus people who live next door to
them that have chosen to go directly into dead end jobs, but at
the same time go to school part time to help increase their
earning power over a period of time?
There are numerous programs which Secretary Herman can
outline that are available for people to combine the two or
that they can get into. But the States addressing the issue of
fundamental fairness, some States have struggled with it and
said, yes, you can go to a 2-year community college. Other
States have said, well, maybe for certain people a 4-year
program in nursing, for example.
I fought the State of New York, when I ran Hunter College,
trying to get them to allow welfare, former welfare, recipients
to stay in 4-year nursing programs because my belief was that
their earning power at the end would be substantially better.
But I do understand the fairness problem, because at that
institution were people from the same neighborhoods, with the
same socioeconomic backgrounds that were combining the two and
killing themselves in the process for doing that.
Senator Murray. Well, if nobody----
Secretary Shalala. So I think the States have----
Senator Murray [continuing]. Is in our nursing programs,
then we do have a problem.
Secretary Shalala. Right. And nursing programs are a
particular problem, because it is hard to do them part time.
There are a set of programs, physical therapy, nursing, where
it is a particular problem because it is hard to do those
programs part time. You can do a 2-year program part time
often, a certification program, but it is hard to do a 4-year
program part time.
So the States can make the decision to allow someone to do
it, and many of them have struggled with the decision. We do
not have a national standard that we can impose. Congress
specifically----
Senator Specter. Senator Murray, would you like that answer
amplified for the record? Because we are going to have to move
on.
Senator Murray. I would. I know Secretary Herman, if she
could just comment in a 10-second time frame, I would like to
hear what she has to say.
Senator Specter. Take 10 seconds, Secretary Herman.
Secretary Herman. I think Welfare-to-Work had unintended
consequences in regard to educational opportunities. We did
amend that last year to allow vocational education and job
training for up to 6 months. And we are making further
progress.
Senator Specter. Thank you very much.
Thank you very much, Senator Murray.
Senator Reid.
Senator Reid. Thank you very much, Mr. Chairman.
I am wondering if--in the audience is Dr. Koplan. I wonder
if he could respond to some questions. He is head of the
Centers for Disease Control.
Senator Specter. Well, we had planned to call him at the
conclusion of this panel. But if you want to do that in your 5-
minute round----
Senator Reid. That would be great.
Senator Specter [continuing]. We would do that.
Wait just a minute, though.
We have asked Dr. Jeffrey Koplan to be present at this
panel today. And I had, as I stated, planned to call him at the
conclusion of this round. But to accommodate Senator Reid on
his schedule, we will move to Dr. Koplan at the present time.
We have written Dr. Koplan, and he has responded. And those
letters will be made a part of the record concerning
expenditures made at the Center for Disease Control, which are
at variance with what the congressional authorizations were,
congressional appropriations.
With that, Senator Reid, you can begin your round of
questioning.
DR. WILLIAM BELLINI'S STATEMENT
Senator Reid. Thank you very much, Mr. Chairman. You, as
usual, are right on line. I was greatly disturbed to read a
quote earlier this month in newspapers all around the country,
in The Washington Post particularly, when one of Dr. Koplan's
staff members, a Dr. William Bellini, who is in charge of the
measles program, told the inspector general, and I quote,
``It's a bigger crime to follow Congress's direction than to
spend money where science dictates,'' end of quote.
This is the basis for a very troubling thing. In the mid-
1980s, Mr. Chairman, in Lake Tahoe, a series of people came
down with a disease that was then known as Epstein Barr
syndrome that is now is chronic fatigue syndrome. Under the
good auspices of this committee, we were able to get some money
to specifically study that disease.
We were very disappointed to learn that that money was
spent for something else, because they thought it could be
better spent on something else. If it were only Epstein Barr
that money has not been spent properly for, maybe we could say
that was a mistake. But now we learn that the Hanta virus,
money that was set aside for that, which is also a western
United States disease where people are dying as a result of
this disease, who are being exposed to something, we believe,
dealing with rats. We are not too sure.
And then I have been getting mail the last few days, Lyme
disease, the same thing. You know, we have report language, and
it is ignored on many occasions. But when we appropriate money
for a specific program, that is the program it should be spent
on. And words cannot describe how disappointed I am.
I have people all over the country that are writing to me
that have been extremely sick. And this is not just Congress
coming up with this. We have had the Inspector General look at
this, and he acknowledges that they are spending money on
programs other than what it was dictated for.
So, Dr. Koplan, as I say, I just think this is outlandish.
And I think the excuses that we have from your department are
not very good. I appreciate the apology. You in writing
apologized. But the answers that we have are just very, very
bad.
I recently received an employee, who, if their name were
disclosed, would of course get fired. But they have sent me a
batch of stuff, which I have sent on to the inspector general,
where this is going on in the Centers for Disease Control.
I do not know how to say this, but a stop has to be put to
this. It is very, very difficult. It took me more than 10 years
to get specific money for this Epstein Barr program. And then
to have your office, your department, spend it on something
else, and then we learn later it is Hanta virus, it is Lyme
disease, we do not know what else.
How do you respond to this? And I would also like to know
how in the world can you have somebody working for you that in
effect spits in Congress's face, William Bellini, who says,
``It's a bigger crime to follow Congress's direction than to
spend money where science dictates.''
[The information follows:]
QUOTE FROM THE WASHINGTON POST
The comments at the hearing, drawn from a Washington Post article,
were inaccurately attributed to Dr. William Bellini, a Centers for
Disease Control and Prevention employee.
Secretary Shalala. Senator, if I might----
Senator Reid. I asked the questions, Ms. Secretary, to Dr.
Koplan.
Dr. Koplan. Senator Reid, thanks for giving me the
opportunity to respond to this. First of all, let me answer
your last question first, which is that we have 8,000
employees, and the sentiments that you just expressed, that one
of them was quoted as saying, are antithetical to my own
beliefs and opinion.
As Director of CDC, I can tell you that the vast majority
of our staff, and all of our senior managers and decision
makers believe strongly in following the directions of
Congress, the budgetary directions of Congress and
congressional intent. And that has been made clear to our staff
top to bottom. And I strongly believe that, and I cannot
emphasize it enough to you.
Individual quotes, certain individuals in the institution
do not speak for the institutional as a whole.
Senator Reid. Do we just let that go? Is there anything in
his record? Do we let it--is he just down there drawing his
merit pay with this?
Dr. Koplan. I do not know the individuals involved in
detail.
Senator Reid. But do you not think that should be flagged
and take a look at this? I mean, this does not speak well of
the Centers for Disease Control.
Dr. Koplan. All of our staff have been told by me----
Senator Reid. I want to know what----
Dr. Koplan. Might I finish, Senator?
Senator Specter. Senator Reid. Senator Reid, let him finish
his answer.
Dr. Koplan. All of our staff have been told in very clear
terms what the relationship with Congress is, how I view the
importance of that, and what our responsibilities and
obligations are, both the Congress and the American public. And
the type of attitude you just described is not tolerated in
what we do.
We have put in place----
Senator Reid. OK. Not tolerated. What has happened to
Bellini? Nothing?
Dr. Koplan. I cannot describe personnel actions toward
individuals, but I believe individuals are still allowed to
express themselves on a wide variety of topics that I cannot
necessarily tell them what to think.
That is not an attitude or an expression of opinion that is
likely to encourage someone to take any more management
responsibility or have any policy options within our
organization.
By the same token, I have not had a chance to speak to this
individual. I do not know what he was saying in general. And I
do not know where the quote comes from.
Senator Reid. I told you.
Senator Specter. Senator Reid. Senator Reid, let us come
back to this. Senator Craig has been waiting.
We are going to take it up, and we will have another round
in a moment or two.
Senator Craig.
Senator Craig. Mr. Chairman, I came here to listen. I am
intrigued by what Senator Reid is saying. If you can trust the
Center for Disease Control, nearly every agency--not every
agency. A good many agencies I work with more dominantly than I
do these----
Senator Reid. If the Senator would yield, I heard the
Senator dealing the Forest Service a week ago, the same
situation.
Senator Craig. Last year it was $400 million there, and
they do not come back to their authorizing committees to get
reauthorization. They just reprogram. And that is very
frustrating to a Congress that oftentimes directs very
specifically where the money should be spent.
Now there are ways to reprogram money. You come back to the
authorizing committees, and you get the consent of Congress to
do so. Somehow in this administration we have had a real
problem at times. But I am not singling out any one of these
secretaries. When I say that, I am saying that in a generic
form.
And, you know, as a member of the Appropriations Committee,
we only know how to get tougher by firewalling and
straightjacketing. And that does not offer the flexibility that
sometimes is necessary. But I do not blame the Senator for
being frustrated. There is clear evidence of those kinds of
remarks and attitudes.
Senator Harkin. Would the Senator just yield for a second?
I think the Senator may have just misspoke. Reprogramming comes
to the appropriating.
Senator Craig. You are correct. Reprogramming comes to the
appropriating committees. But oftentimes, reprogramming, if it
is significant enough, the appropriating chairman also consults
with the authorizing chairman, which is wise and responsible to
do when it comes to significant changes in direction that have
happened. That is what I am suggesting.
Mr. Chairman, thank you very much.
Senator Specter. Thank you, Senator Craig.
Let us proceed with Dr. Koplan, since Senator Reid has
brought it up. And we will conclude this. We do have some other
questions for secretaries.
Dr. Koplan, the difficulty arises in part from the fact
that there had also been misstatements by the Center for
Disease Control as to the chronic fatigue syndrome research
program, where funds were allocated in a different way, so that
it appears to be a repetitive problem.
Senator Reid has pressed you about Mr. Bellini's statement.
Had you heard that before Senator Reid raised it with you this
morning?
Dr. Koplan. I have not heard Mr. Bellini's statement
before. No.
Senator Specter. You had not heard about it before today?
Dr. Koplan. We had an inspector general's report that was
delivered to me in May. There were background paperwork to that
report that an inspector general's office did not provide me
with. And I believe some of the quotes that are being provided
are from background documents that I had not seen.
Senator Specter. But your statement to the subcommittee is
you had not heard about what Mr. Bellini had said prior to the
time Senator Reid brought it up this morning.
Dr. Koplan. I had not heard Mr. Bellini's quote.
Senator Specter. All right. Well, that is--first of all, we
ought to make the determination as to whether it is true that
he in fact did say it. And if we make that determination, then
I think there ought to be an investigation by you in the first
instance, Dr. Koplan, as head of the Centers for Disease
Control, to see what an explanation would be, if we determine
the statement was made.
When you deal with this sort of a statement, you have a
potential violation of the Penal Code Section 1001, a false
official statement. And we do not want to start to deal with
that. But there is a high level of concern, really anger, in
the Congress about what has happened here.
Dr. Koplan. Chairman Specter, I share it. I share that
concern. And the institution, CDC, and myself as responsible,
erred in both reallocating funds and in not reporting it and
not having appropriate discussions with the folks who we are
dependent on for our well-being and for your trust. We have
made a mistake. That mistake seems to be larger than just one
unit.
And because of that, we have put in place recently I think
strong measures to address it and to address it across the
whole institution. We have done several of them in partnership
with Secretary Shalala.
OIG REPORT
Senator Specter. Have you inquired of the inspector
general, who made the report, what the details were, so you
would be in a position to answer?
Dr. Koplan. The inspector general presented me with a
report last May.
Senator Specter. You have already said that. My question
is: Have you inquired of them to find out more?
Dr. Koplan. We met with them. They gave us a set of
recommendations to put in place. We put those in place and went
several steps further in putting into place recommendations.
Senator Specter. Let me come back to my question, which you
still have not addressed. Did you inquire of them as to what
other information they had? You said they submitted a report.
You said you met with them, and you put more steps into play.
But have you found the details of their investigation? Have you
said to the inspector general, tell us all you found here, so
we can deal with it?
Dr. Koplan. We asked for all they had found, and they gave
us that set with recommendations. They did not provide us with
background material, which they normally do not supply to
agencies; in other words, interviews they do with everyone who
they met with.
Senator Specter. Did you ask for that?
Dr. Koplan. No, we did not ask for it.
Senator Specter. Well, I suggest that you do that. I would
suggest you make the inquiries.
What assurances are you in a position to give that this
problem is going to be corrected in a forceful way?
Dr. Koplan. Thank you. One, we are working with the
department. The Department is placing a financial officer to
provide oversight for our Center for Infectious Disease
expenditures. That is the larger unit in which Hantavirus and
chronic fatigue syndrome sits.
Senator Specter. Are there any items besides those two
where you have knowledge that there has been misstatements by
the Centers for Disease Control?
Dr. Koplan. There are no items besides those two in which I
believe there are misstatements. But we are putting in place a
system that is going to look broadly throughout the agency,
including a management review of all of CDC's budgetary
practices, to look everywhere and try to uncover it.
Senator Specter. Have you taken any disciplinary action
against anybody who made a false report?
Dr. Koplan. I have reassigned a senior official in our
Division of Virology and put new leadership in the Division of
Virology.
Senator Specter. Anything beyond the reassignment?
Dr. Koplan. Reassignment is a pretty strong action in our
institution.
Senator Specter. Well, sir, my question was: Anything
beyond a reassignment?
Dr. Koplan. No.
Senator Specter. Just one individual, one reassignment.
Dr. Koplan. That is correct.
Senator Specter. Is that individual the only one who has
been determined to have made a false statement?
Dr. Koplan. I am not sure that individual has made a false
statement. That individual was reassigned to assume other
duties to----
Senator Specter. OK. Why did you make a reassignment of
that individual?
Dr. Koplan. I think there are other duties to which he is
better suited. And we can make more improvements in the
division for which he was responsible and----
Senator Specter. So that reassignment is not related to the
false statements.
Dr. Koplan. I am not sure of the false statements you are
referring to, sir.
Secretary Shalala. Senator Specter.
Senator Specter. I want to finish this. I want to finish
this.
Have you made a determination as to any employees at CDC
who made false reports relating to these two items, chronic
fatigue syndrome and Hantavirus?
Dr. Koplan. There have been disciplinary actions taken at
CDC to personnel.
Senator Specter. How many for false statements made with
respect to Hantavirus and chronic fatigue syndrome?
Secretary Shalala. Senator Specter, we have a privacy issue
here, if we might take a break and talk to you privately about
what we can say on the record.
Senator Specter. Well, is there a privacy issue, Madame
Secretary, if names are not named?
Secretary Shalala. Yes.
Senator Specter. Why?
Secretary Shalala. Because anything that could lead to the
individuals--you are the lawyer. But I certainly would like to
discuss this, not on the record, before the director of the CDC
responds to that.
Senator Specter. Well, I do not see a privacy issue in the
absence of any specified person being identified or a category
which could lead to the identification. But at your request, we
will take a brief recess.
Let us step into the back room, Madame Secretary, Dr.
Koplan, Senator Reid.
Senator Harkin. I think I am next. I just might say that I
have looked at this issue, too. And I am equally upset about it
as just about anybody else could be. And I think I have looked
into it in-depth. I would just like to state for the record
that I have met with Dr. Koplan both here and in Atlanta about
this issue.
It goes without saying that people should follow the intent
of Congress. I can somehow see how this thing transpired. I do
not know that anyone made intentionally false statements.
I think the budget office responded to a question asked by
Congressman Porter, I think, using what knowledge they had at
the time of what was done. I do not think that the budget
office--this is my own opinion--really had the information
about what had happened to the funds.
I am not--I do not want to sit here and go on with this
thing that somebody made false statements. I do not know that
that is so. And from my look at it, I do not believe that is
so. I believe statements were made based upon the best
information that people had at the time when they made that
statement. That is not intentionally making a false statement.
I want to make that clear.
Second, I think what maybe Secretary Shalala said earlier
about being out of sight, out of mind, I really do believe that
whereas we have in the past continually worked with NIH as to
how they are spending the money that we give them, and we do
not earmark, but a lot of times we make our intentions known
about where Congress wants to move, whether it is in AIDS, Ryan
White type of initiatives, or whether it is in breast cancer
research, a myriad of things that we give congressional intent.
We are constantly--you do it, Mr. Chairman. I did it
before, when I was chairman. We constantly have them up here to
tell us what they are doing and how they are proceeding. And I
would say even myself, when I was ranking on this, I did not
bring CDC up here to talk to them. They were down there doing
their thing.
And I just think that perhaps we need a new relationship
with the Centers for Disease Control and Prevention, to keep a
closer working relationship on exactly how this money is going
out and what they are doing and how they are operating.
I talked with Dr. Koplan about what had happened down there
and the reassignment of certain individuals. I had not heard
the statement before either. This is the first time I had heard
that statement. And I obviously need to know more about whether
it is so and how it was said and that kind of thing before we
can take action on it.
But from what I have heard from Dr. Koplan, I am reasonably
assured that steps have been taken on their end to correct this
and make sure it does not happen again. I think what we do,
what we have to do here as appropriators, I believe, is to
establish a closer type of a working relationship with CDC and
to have them up here more often to talk about where we are
investing this money and what the intent of Congress is.
But I think this is a two-way street. You had that
relationship with NIH. I just do not think we have had it with
the CDC.
Senator Specter. Well, thank you, Senator Harkin. I do not
know if there has been a false statement made either here. But
when Dr. Koplan testifies that one person has been reassigned
and that that is not related to a false statement, but for
efficiency, that is really not--that is really beside the point
of the question.
And then he said there has been disciplinary action taken.
With the record of the Center for Disease Control and the very
substantial sums involved here, my sense is that this
subcommittee has a duty to inquire and to find out what has
happened.
We are going to respect privacy. The questions asked of Dr.
Koplan did not go to any individual or any category of
individual, but just to find out if there had been a report of
falsification and, if so, whether it was determined to be true
or false and, if so, what action was taken.
But when Secretary Shalala wants a session off the record,
we will do that. Let us do that promptly, because we are going
to have to conclude this hearing in the course of the next 10
minutes.
Do you want to step back, Secretary Shalala, Dr. Koplan.
Senator Specter. The subcommittee will resume.
We had allocated 2 hours for this hearing. And I am
scheduled to meet with the House leadership at 11:30 to see
what the funding is going to be for this subcommittee.
We are working far in advance of the October sessions on
that with my purpose being to try to see if we cannot get
adequate funding for these three departments.
Secretary Shalala has raised a question about the Privacy
Act, and I have grave reservations as to its applicability in
this situation. But we will pursue it to see if there is a
basis for it. And we will proceed to work with Secretary
Shalala and Dr. Koplan on private meetings and then make a
determination as to what further hearings are needed.
My sense is that on a matter of this sort, there is public
interest and a right to know, and that this incident could have
very substantial therapy for other branches of government. I do
not know what the facts are, whether there has been any
violation or whether there is any implication of 18 U.S. Code
101. We have to make that determination.
But in view of the time and in view of the request, we will
do that privately. And we will report publicly what our
findings are. And to repeat, if there is a necessity for a
public hearing, we will reconvene.
Let me turn now to Senator Cochran.
DELTA REGIONAL AUTHORITY
Senator Cochran. Mr. Chairman, thank you very much. I came
over to urge the secretaries to look at the Delta Regional
Authority proposal the President has made. Yesterday they had a
meeting at the White House with governors from the States that
are involved.
And in each of these instances, I think there are
significant roles that can be played by these three departments
in this undertaking, without really using any of the proposed
spending to establish a new Federal agency.
This authority, in my judgment, may or may not be needed in
the context that is being proposed, if we use the resources
that we have and some of the existing programs, like Job Corps,
where we can train people who need jobs. We have a growing
economy all over the country, but it is growing much slower.
And in some places, it is negative, for example in the
Mississippi Delta and in the lower Mississippi River Valley
region.
But in education, we have teacher training programs. Delta
State University has a $1.5 million appropriation that this
committee approved last year. There are more parts to this
training and upgrading of skills, of teachers, recruiting
people, a superintendents training program that has been
proposed as a part of this program that has not been funded.
We think that if you could go back and take a look at some
of the proposals that places like Delta State University,
Mississippi Valley State University, Alcorn State University--
those are all in my State--but the community colleges, too, can
play a major role, if we give them a little extra money. They
have the know-how. They know what the problems are.
And I think we are missing the bet, if we divert attention
from some of the existing resources that we have, like Job
Corps, teacher training programs and the rest, and in the rural
health centers, to be sure that we have an infrastructure
there.
RURAL HEALTH CENTERS IN THE DELTA REGION
We have introduced legislation this week to double the
appropriation over the next 5 years for rural health centers.
They have done a very effective, cost-effective, job. We hope
the administration can support this increase in funding that
Senator Bond and I and others are sponsoring here in the
Senate.
So I do not have any real questions. I have some, but I am
not going to ask them, because we are out of time. But I just
wanted to let you know what my highest priority was this
morning for discussion with you.
So we appreciate you being here and look forward to working
with you on these and other issues as we go through this next
fiscal year. Thank you very much.
Secretary Riley. Mr. Chairman, if I might respond to the
comment. And I thank you for it. As you know, I was in
Mississippi last week and got over into the Delta Region and
went to Delta State University and I also was in the Cleveland
area. And I strongly support the tenor of your remarks. I was
there. I talked to a lot of school people and parents, higher
education people.
I did the same thing in Iowa a couple of weeks ago and saw
in those rural areas--one little school district in Mississippi
even told me they had 17,000 people in the district, and they
had lost something like 1,000 jobs over the last couple of
years.
And then we have a program that they very much want to use,
like Gear Up to connect up colleges with these struggling
middle schools, and yet it calls for a match, which is a very
legitimate thing for it to do. But they say they have no way of
participating. They do not have any money for the program match
requirement.
In this school construction thing, where we do have
resources for some grants in those very needy areas, they
cannot support a school bond issue. And so I think it is good
for all of us to get out and see the kind of thing you are
talking about. Those people are working so hard in the Delta
Region, and I was very proud to be there with them.
Senator Cochran. Thank you very much, Mr. Secretary.
Senator Specter. Thank you very much, Senator Cochran.
YOUTH SAFETY AND HEALTH QUESTIONS FOR THE RECORD
There will be more questions submitted for the record.
Senator Campbell and Senator Domenici made specific requests.
And I would like the observations of all three of you in
writing on what we ought to be looking toward on movies,
television and video games, an enormously sensitive subject.
And in structuring our program against youth violence, we have
deliberately not moved in the direction that everybody pummels,
but have treated this as a national health problem, very much
as Dr. Koop suggested years ago, putting it under the Surgeon
General, so he has the responsibility.
And I have asked each of you to let me know who your point
persons will be, because this subcommittee intends to conduct
extensive oversight, really working with you, as we started to
do last year, but give our views on the subject and interact,
so we can make more money available to you or make more
reallocations or get the legislative branch in with our power
of the purse to help out on that.
STEM CELL RESEARCH AND DIABETES
We are going to ask you some questions on stem cells. There
is a report today about some phenomenal new advances on mice
and diabetes. We had a postponement hearing on that subject
that Senator Lott has agreed to bring that subject up as a
free-standing bill, very important medical research. And we are
going to do our best to come to grips with these budget issues.
Senator Stevens came and told you that the money was not
there for what you have asked for. And that is a prevailing
view. When you have a total budget of $622 billion, it pushes
up, aside from the Balanced Budget Act and the caps, which we
are going to have to act on one way or another, you do have the
issue. Nobody wants to invade the Social Security surplus. So
that is a limit that nobody is going to transgress.
But we are going to work with you and try to see to it that
you are adequately funded. I think you were last year, and we
are going to try to the good job for America this year, with
your cooperation. Thank you all very much.
I will insert a statement from Senator Gorton for the
record.
[The statement follows:]
Prepared Statement of Senator Slade Gorton
For decades now, Washington, D.C. has taken almost complete
responsibility from local communities for how our schools should be
run. Over the past few years, I've visited perhaps over 100 schools and
listened to countless numbers of parents, teachers and principals, and
they almost universally agree that it's time for Congress and the
President to restore the authority local communities once had to make
decisions for their local schools.
Last year I proposed, along with Mr. Goodling in the House, the
Academic Achievement for All Act, also known as Straight A's. This bill
is based on the simple premise that in exchange for a significant
increase in flexibility states and school districts would be held to a
higher standard of accountability. Under my proposal, states would have
the option of submitting a charter proposal that would set specific and
measurable performance goals to reach by the end of five years. If
approved, states would be allowed to use any of their regular Federal
K-12 formula program funds for state education priorities and programs,
in exchange for being held accountable for meeting their goals. States
would be free to combine their federal funds from multiple programs to
more effectively address the needs of students in their state.
Alternatively, states would be free to administer Federal education
programs the old way--Straight A's does not eliminate any program. It's
the state's choice of which approach to use.
What this means for states and school districts is that they can
use federal funds for any initiative that improves performance of
students in your state. States that choose to participate can focus
more funds on disadvantaged students, increase efforts to improve
teacher quality, reduce class size or even hook up all their classes to
the Internet. The one string is that these efforts must increase the
achievement of all students--including the lowest performing students--
over the course of five years.
If states do not substantially meet those goals, they would lose
their Straight A's status, and revert to the categorical, regulated
approach under current law. If states do well and significantly reduce
achievement gaps between high and low performing students, they will be
rewarded with additional funds.
Finally, school districts would not lose any Title I funding. If
Title I, Part A ($8 billion program for educationally disadvantaged
children) is included by a state, each school district in the state
would be assured of receiving at least as much money as they received
in the preceding fiscal year.
I've received a good deal of feedback from my constituents on my
proposal, and a great deal of it has been positive. They do not shy
away from being held strictly accountable for the academic success of
all children if they are freed from the myriad of rules and regulations
imposed on them by the federal government. Mr. Secretary, tomorrow the
Senate education committee will take a closer look at reauthorizing
ESEA and included in the package is Straight A's.
The very fact that Straight A's is being adopted into any ESEA
reform bill sends a dramatically different message to state and local
school districts across the country. For the past 35 years, we have
consistently told our local educators that ``D.C. is in charge of
running schools across the country.'' Now, as the education debate gets
underway, we are going against the grain by trusting our state and
local education officials to do what they think is best for our
children. I ask you to back me in that endeavor and put your trust
behind our teachers, rather than D.C. bureaucrats.
All children can learn, and they will do so only because of the
dedication and hard work of those who know their names, not because
those of us in Washington, D.C., create a number of new programs with
good intentions. Mr. Secretary, I urge you to seriously consider the
merits of the Straight A's proposal and support funding priorities that
provide those who know our children best--their parents, teachers,
principals, superintendents, and school board members--with the
flexibility they need to educate our children.
ADDITIONAL COMMITTEE QUESTIONS
Senator Specter. Thank you very much. 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:]
DEPARTMENT OF LABOR
Question Submitted by Senator Kaye Bailey Hutchison
BONUS INCENTIVE ACT
Question. Madam Secretary, as you know, the Senate recently passed
legislation I introduced, the Bonus Incentive Act, which will allow
employers to pay their hourly wage employees performance-based bonuses,
without the unnecessary and burdensome need to go back and recalculate
the employee's overtime pay. Typically, this results in very small
changes to overtime pay, while it clearly discourages thousands of
American businesses from paying their employees bonuses. One estimate
is that if my bill passed, it could mean an average increase to an
hourly worker of $1,000 per year in bonus pay. Do you support this
legislation, and if not, why not?
Answer. The Bonus Incentive Act was attached to a provision to
increase the minimum wage in an amendment to the Bankruptcy Reform Act
of 1999 and passed by the Senate in February. This measure would amend
the Fair Labor Standards Act (FLSA) to exclude from the definition of
``regular rate''--the basis for calculating overtime premium pay (time-
and-a-half-pay)--any payments made to reward employees for meeting or
exceeding productivity, quality, efficiency, or sales goals, i.e., the
additional compensation provided through gainsharing plans, incentive
bonuses, commissions, or other performance contingent bonus plans.
The Department strongly opposes this amendment. If enacted, it
would substantially reverse the FLSA's long-standing overtime policy
and drastically weaken existing protections for workers to receive true
time-and-a-half overtime premium pay. These requirements, which have
been in place for over 60 years, provide vital worker protections that
discourage employers from working their employees excessively long
hours and ensure fair compensation to those who bear the burden of
working extended hours.
This bill would not guarantee workers the right to receive
incentive compensation for any additional hours they work and
therefore, does not ensure that workers--who may have to work
excessively long hours for their employers--will ever share in any of
their employer's gains. The amendment would, however, allow an employer
to pay artificially low hourly wages and structure its compensation
system on newly ``excludable'' bonus pay. Such a compensation structure
would enable the employer to effectively transfer much of its business
risk directly to its employees. The workers' only rights would be
overtime pay at time-and-a-half a reduced hourly wage--not their true
wage.
Moreover, the amendment would encourage employers to require
employees to work longer hours at lower earnings, directly contrary to
the statute's original intent-to limit the detrimental impact that long
work hours can have on the health, efficiency and general well-being of
workers and their families. The Administration's Statement of Policy on
November 8, 1999 regarding the Bankruptcy Reform Act of 1999 reiterates
the President's position in stating that if Congress sends him a bill
``delaying the [minimum wage] increase, repealing overtime protections
for certain workers, adding costly and unnecessary tax cuts . . ., he
will veto it.'' In considering identical legislation in the House (H.R.
1381, the Rewarding Performance in Compensation Act) I advised Chairmen
Ballenger and Goodling that I would recommend that the President veto
the legislation because it is contrary to the best interest of this
Nation's working men and women.
______
Questions Submitted by Senator Robert C. Byrd
NATIONAL MINE SAFETY AND HEALTH ACADEMY
Question. What amount of revenues did the Academy receive for the
use of its facilities by mining officials from foreign nations for
fiscal year 1998, fiscal year 1999, fiscal year 2000, and the projected
amount for fiscal year 2001?
Answer. The training facilities of the National Mine Health and
Safety Academy are used to promote international mine safety and health
through training and exchange of information and techniques. Because of
the mutual benefit of exchanging health and safety information with
other nations, we have waived food and lodging fees for international
groups that have been invited to participate in MSHA training programs.
No change is anticipated for fiscal year 2001. The sponsoring country
pays travel costs to and from the Academy.
Question. What were the staffing levels at the Academy for those
same years?
Answer. Staffing levels at the Academy have remained relatively
constant in recent years. For the years in question, they are:
Fiscal year 1998--63 FTE
Fiscal year 1999--65 FTE
Fiscal year 2000--66 FTE
Fiscal year 2001--66 FTE (est.)
Question. Has the training provided by the Academy to mining
officials from foreign nations led to a reduced number of mine-related
deaths in those countries? What countries benefitted most from this
training?
Answer. Since 1998, the Academy has trained mine inspectors and
mining officials from South Africa, Hungary, Poland, Peru, Malaysia,
Australia, Mexico, the Ukraine, Croatia, Russia, and Thailand. In
addition, the Academy has hosted a number of international mine rescue
teams, including those from Russia, Poland, and the Ukraine.
The following information reflects the actual and estimated number
of mining officials from foreign nations trained or provided training
guidance at the Academy during fiscal years 1998 through 2001:
Fiscal year 1998--59
Fiscal year 1999--83
Fiscal year 2000--124 (est., with 32 to date)
Fiscal year 2001--250 (est.)
Both MSHA and the visiting officials recognize the value of sharing
technical expertise to reduce hazards in the mine industry. Training
and materials provided to these delegations give the international
delegations a basis to make improvements in health and safety
conditions in their respective countries. Generally, improvements in
the reduction of mining-related accidents are realized over extended
periods.
At this time, there are no statistics available to indicate the
degree to which this training has affected miners' health and safety in
the individual countries. There is, however, anecdotal evidence that
suggests that it has led to some improvements in participating
countries. For example, following the March 2000 methane explosion in
the Ukraine, we received a letter from the Ministry of Labor and Social
Policy requesting assistance from MSHA in developing health and safety
programs. Additionally, the letter stated that they attributed their
improvements in mining safety during 1999 to the assistance and support
provided by MSHA (letter attached).
Ministry of Labor and Social Policy of Ukraine,
March 20, 2000.
Hon. Steven K. Pifer,
Ambassador of the United States of America,
Vul. Yuriya Kotsyubinskoho 10, Kiev, Ukraine.
Dear Ambassador Pifer: As you are aware, the coal industry of
Ukraine has recently experienced another unfortunate accident--this
time at the Barakova Mine that resulted in the death of eight-one coal
miners, and seven more being injured. During the past few days we have
received many conveyances of sympathy and concern from various U.S.
governmental organizations, individuals, and friends. All of this has
been greatly appreciated.
This was the worst accident that the coal industry has experienced
for over twenty years, and it came after we had achieved a positive
trend during 1999 in the number of deaths and accidents in this
industry. We attribute many of these positive results to the assistance
and support that we have received from your Department of Labor-Mine
Health and Safety Administration (MSHA) during the past two years under
our Cooperative Agreement. This program has been instrumental in
raising the awareness of safety at our coal mines; it has greatly
enhanced the effectiveness of the Labor Safety Committee and the morale
of its workers.
The purpose of my letter is humbling but very necessary under the
current situation in Ukraine. The Labor Safety Committee requests your
consideration and support in a program to help create a safer
environment for the coal miners of Ukraine. Specifically, we would be
interested in joining with MSHA in developing a program to address the
following issues:
--raising awareness of coal miner safety by developing and presenting
a training program designed for Ukrainian mining conditions and
practices,
--develop a program to use the Barakova Mine as a test case to
demonstrate the effectiveness in the utilization of rockdust to
control excess underground dust. The success of this program
will result in the writing of new regulations that will be
implemented at all Ukrainian coal mines, and
--a method to improve communication during mine accident
investigations.
We are aware that the resources of the U.S. Government are not
unlimited, but believe that a jointly developed program between MSHA,
the Labor Safety Committee, and the Ministry of Fuel and Energy can be
a cost effective method ti improve the health and safety of our miners.
Thank you for your consideration of this vital issue.
Sincerely,
P. Ovcharenko,
First Deputy Minister.
CONVENTION 176
Question. The General Conference of the International Labor
Organization adopted Convention 176 on June 21, 1995, establishing
minimum mine safety and health standards for the international
community. Convention 176 was based on the Federal Mine Safety and
Health Act of 1977, and if ratified, the U.S. would be in full
compliance without the need for any further legislation. Would you
please explain the Administration's position on Convention 176, and any
externalities that could result from its ratification.
Answer. The Administration strongly supports ratification of
Convention 176. The Convention recognizes the importance of preventing
injuries and deaths in the mining industry throughout the world.
Widespread ratification of the Convention is in our interest since it
would help raise international standards to the same high level
reflected in our own law. U.S. ratification would reinforce the
important role of the ILO in developing effective labor standards for
the global economy. The National Mining Association and the United Mine
Workers of America worked with the Department of Labor in developing
Convention 176, and both organizations support its ratification.
Convention 176, as you indicated, is patterned after our own
Federal Mine Safety and Health Act of 1977 (Mine Act). Ratification
therefore does not require any change to U.S. mine safety and health
law or regulation. This conclusion was reached by the Tripartite
Advisory Panel on International Labor Standards (TAPILS), which
carefully examined Convention 176, including its negotiating and
legislative history. TAPILS' membership includes representatives of the
Departments of Labor, Commerce, and State, the U.S. Council for
International Business, and the AFL-CIO.
The Mine Act is the foundation of the safety and health successes
that we have achieved in this country. The Mine Act, as well as its
predecessor statute, the Federal Coal Mine Health and Safety Act of
1969, are universally regarded as critical in having reduced the number
and severity of mine explosions, mine fires, and other catastrophic
events in the mining industry in this country. In developing Convention
176, the U.S. Government, industry and labor agreed that the adoption
and enforcement of a common set of safety and health laws by the
international community will help ensure safe and healthful working
conditions for miners throughout the world, as well as help ensure that
U.S. businesses can compete fairly in the world economic market.
In recent years, the Department of Labors' Mine Safety and Health
Administration has provided mine safety and health assistance and
advice to several countries. These exchanges have made us even more
firm in our conviction that establishing uniform safety and health
standards is essential for raising labor standards globally. Mining
remains one of the most hazardous industries, both here and abroad. In
part due to inadequate health and safety standards, the human toll
associated with mining is particularly high in certain foreign
countries. As recently as last month (March), a methane explosion in
the Ukraine resulted in the death of 80 coal miners. According to
reports, at least 274 miners were killed in the Ukraine in 1999, and
about 360 in 1998. Reports indicate that South African mines recorded
312 work-related deaths in 1999, and that mining accidents in China
killed more than 3,000 people in the first 9 months of that year.
Convention 176 has been ratified by 12 nations. The South African
Parliament agreed to ratification in December 1999, and is currently
processing the procedural papers needed for the International Labor
Organization to officially recognize South Africa as a ratifying
country. We were extremely pleased that the U.S. Senate gave its advice
and consent to ratification of Convention 182, the Worst Forms of Child
Labor Convention in November 1999. Like ratification of Convention 182,
U.S. adoption of Convention 176 would reflect our commitment to work
together with labor and business interests to raise labor standards
around the world.
______
Questions Submitted by Senator Herb Kohl
WORKER ADJUSTMENT AND RETRAINING NOTIFICATION ACT
Question. Recently there have been plant closings in Wisconsin that
have violated the WARN Act. This act has several loopholes in it,
however, and it does not allow the Department of Labor to investigate
or enforce the act. If the Department of Labor had the authority to
investigate and enforce the act, how many workers could be helped and
what would the possible impact be? How much funding would this effort
require of the DOL?
Answer. As part of the development of our dislocated worker
consolidation bill in 1993, DOL conducted consultations on the
possibility of amending WARN in the areas of coverage and enforcement.
No action was taken for a number of reasons, including:
--The concern that amendments might reopen issues and upset the
fragile consensus that produced the original statute, and
--The belief that coverage changes would have to be accompanied by
agency enforcement in order to be effective and the cost of
that enforcement, in both dollars and Federal positions, would
be great.
These factors have not changed. In fact, support for the
Department's role in enforcing labor laws and the positions and funds
comprising that enforcement has become an issue in cases where Federal
law already assigns the Department these responsibilities.
Advance notice of layoff is a critical component for workers to
begin the adjustment process, and for the workforce system to provide
the specialized assistance needed by affected workers. The importance
of early notification is recognized by the Department.
The positive impact of DOL having enforcement authority would be in
the number of additional workers who receive advance notice of layoff.
(This assumes that DOL enforcement authority leads to greater employer
compliance with WARN.) The Department does not have data on the number
of workers who should have received notice under WARN, but did not.
To promote greater employer awareness of their obligations under
WARN, the Department is exploring a public information campaign and
targeted outreach to employees, employers, and organized labor to (1)
stress the employers' obligations under WARN, (2) encourage advance
notice on a voluntary basis even when WARN may not apply, and (3)
encourage even earlier notification of impending layoffs and closures
than WARN requires.
Finally, WARN enforcement would require about 30 staff, including
those in regional offices, in a management unit in the national office,
and in the Office of the Solicitor, which would involve an estimated
staffing cost of $3.3 million.
WORKFORCE INVESTMENT ACT IMPACT
Question. There is some concern that the Workforce Investment Act,
which will be fully implemented in Wisconsin in July, will already face
a sunset in 2003, too early to fairly judge if the new act is
successful. What is the Department of Labor doing to measure the
Workforce Investment Act's successes or shortcomings and will the data
be enough to get a clear picture?
Answer. The Department has contracted with Social Policy Research
Associates to conduct a process evaluation of WIA implementation. While
there will be a lag time for the receipt and analysis of the initial
WIA performance data (including customer satisfaction), the information
will be instrumental in determining State and local success in
achieving the WIA reforms and the core measures. Our technical
assistance, discretionary grant investments, and performance incentive
awards authorized by WIA are targeted at expanding partnerships in the
One-Stop delivery system. In sum, our focus and resources are directed
at assuring positive outcomes for the customer--increased employment,
retention, and earnings, increased occupational skill attainment, while
meeting the needs of American employers in staying globally
competitive.
TRAVELING SALES CREW INDUSTRY
Question. As you know, I recently introduced legislation, S. 1989,
to make it illegal for young people under the age of 18 to participate
in the traveling sales crew industry. These sellers travel around the
country and go sell products door-to-door. In my state there was a
tragic accident taking the lives of several sellers, many under 18.
Recently there was another accident in California that took the life of
two adults. All in all almost 40 people have been killed in this
industry due to negligence and criminal behavior. I believe that this
is no environment for a child to be in and that it is too dangerous for
minors. Does the Department of Labor agree that the traveling sales
crew industry presents a workplace safety problem?
Answer. Yes. Vehicle related incidents of all types are the number
one killer of young workers--accounting for 43 percent of fatalities
for workers under the age of 18. When you also consider the dangers of
peddling door-to-door in unfamiliar neighborhoods, working long hours
in strange surroundings, this industry is clearly characterized by a
number of serious occupational risks. The Senate Permanent Subcommittee
on Investigations, in 1987, also documented problems of worker
exploitation in the traveling door-to-door sales industry.
Question. Does the industry present an unacceptable risk for
minors?
Answer. As you know, child labor is one of the Department's top
priorities. When children work, they must do so safely and legally. The
youth peddling industry, in general, presents special hazards for young
workers. Children as young as eight-years-old are recruited from poorer
neighborhoods and transported by crew leaders to unfamiliar locations
to peddle candy and other consumer goods door-to-door, at subway stops,
and at shopping malls. We have been looking at the issue of commercial
youth peddling and the special hazards that this industry poses for
young workers. This past spring, the Department joined with the
Interstate Labor Standards Association and the National Child Labor
Coalition to launch a public awareness campaign to educate parents and
young people about the dangers of the youth peddling industry. We are
also working with our State colleagues to coordinate enforcement
activities to protect children who are being exploited. And, we have
sought and obtained additional resources to undertake a thorough
evaluation of the hazardous occupations orders, which began last year
through the National Institute for Occupational Safety and Health.
As you know, we have been and will continue to assist you and
Senator Harkin in your efforts to address problems in this industry. As
I have often stated, the Department is committed to doing everything
possible to ensure that the early work experiences of our young workers
are positive and safe, and do not interfere with their primary
occupations-as students.
______
Questions Submitted by Senator Patty Murray
JOB TRAINING HIGHLIGHTS OF THE 2001 BUDGET REQUEST
Question. The President has requested a total of $2 billion to
provide effective job training assistance to those workers who are
struggling to keep their skills current in our changing global economy.
Can you briefly highlight some of the President's initiatives in his
fiscal year 2001 budget as well as the success of a new innovative
approach to job training in the 21st Century?
Answer. The 2001 budget includes $2 billion for the second year's
request for the President's Universal Reemployment initiative which
will ensure that by 2004: (1) all dislocated workers will have access
to the training and employment services the want and need; (2) that all
unemployment insurance claimants who have been profiled as unlikely to
return to work quickly will get the reemployment services they need to
return to work; and (3) all Americans will have access to the
information and services of One-Stop Career Centers. This initiative
will provide resources to train for or find new jobs, expand and
increase quality of employment services, enhance services for
individuals receiving unemployment compensation, and ensure
availability of the One Stop System, either personally or
electronically.
The programs to be funded are increased by $275.5 million, as
follows:
Dislocated Workers Employment and Training:
--Second year's funding of the President's Universal Reemployment
Initiative.
--The request is $1.77 billion--an increase of $181.5 million over
2000.
--984,000 dislocated workers will be assisted under this initiative.
--Included in the request is $105,100,000 for Skill Shortages grants
that will be financed only if the Administration's proposal for
an employer user fee on the permanent labor certification
process is enacted. Upon enactment of the fee, a budget
amendment will be proposed reducing budget authority.
America's Labor Market Information System (ALMIS):
--Component of the One-Stop Career Centers budget.
--ETA request is $154 millions for ALMIS, $44 million over 2000.
--The major components are: Core Employment Statistics; Universal
Access for Customers/Digital Divide Initiatives; Lifelong
Learning and Earning; and Measuring and Displaying Performance
Information
--ALMIS Services and Products: Mobile One-Stop Vans; Nationwide Toll-
Free Number; America's Job Bank, America's Talent Bank;
Occupation Network (O*Net); America's Learning Exchange; Access
America; Agricultural Network (AgNet).
Reemployment Services Grants to States.--ETA requests $50 million
to provide reemployment services to unemployment insurance claimants to
help them return to work.
I view this historic time of economic prosperity as an opportunity
to address the challenge of bringing skills, jobs and hope to
individuals and communities that for too long have been left behind.
That is why our Budget not only proposes increases in funding for some
formula-funded Workforce Investment Act programs, but also proposes
several targeted initiatives for groups that we have not paid adequate
attention to in the past.
We have asked for an increase of $125 million for Youth Opportunity
Grants to address skills training and job placement in the poorest
urban and rural areas and Indian reservations in America. I recently
announced 36 of these grants. With this first grant competition we were
able to fund only about 25 percent of the eligible communities that
submitted applications. Over 160 communities put together the broad
partnerships and developed comprehensive plans for meeting the needs of
this target population. We had far more high quality applications than
we could fund. These additional dollars will allow us to reach about 20
additional communities . We know that the needs were great in all the
communities that applied and these additional funds will take us a few
steps closer to reaching these communities.
Responsible Reintegration for Young Offenders is a $75 million
pilot and demonstration initiative that will test new approaches to
bring young offenders into the workplace through job training and
placement, and by creating partnerships between the criminal justice
system and our workforce development system. We hope that by developing
models showing how we can work effectively with the criminal justice
system, we can expand services to this population through our State and
local grant programs.
Safe Schools/Healthy Students is an ongoing collaboration among the
Departments of Education, Health and Human Services, and Justice to
promote healthy childhood development and to prevent school violence
and the abuse of alcohol and other drugs. We believe the Department of
Labor has something to contribute to this interagency initiative and
have proposed $40 million so that we can join in this initiative to
enrich the connections among secondary and post-secondary schools,
alternative schools, out-of-school youth programs, and work-based
learning. Some of these funds will be used to assist in building the
infrastructure of youth councils under WIA.
Fathers Work/Families Win is a $255 million, two-part initiative
that grows out of the successful Welfare-to-Work program. Fathers Work
will provide jobs for non-custodial parents--mostly fathers--who owe
child support. Families Win will help low-income parents who are
struggling to make ends meet by providing better access to community
services and upgrading job skills. These families often include members
who have been on welfare or may be at risk of going on welfare, but
because they are employed, most have not received services under JTPA.
I view these initiatives as addressing some needs and target groups
that our workforce development system has not sufficiently dealt with
in the past, and that would not be addressed through our formula
grants. For example, the youth formula programs provide a relatively
small amount of funds to every area in the country, while Youth
Opportunity Grants concentrate a large amount of funds in targeted
high-poverty urban, rural and Native American communities, exactly
where the need is the greatest.
With respect to job training in the 21st Century, I believe the
Workforce Investment Act (WIA), which we are now implementing and which
becomes fully effective on July 1, 2000, offers us a new innovative
approach. Under WIA, information and access to training and other
services will be provided through customer-focused One-Stop Career
Centers in each local area. Training will generally be provided through
the use of Individual Training Accounts, and clients of the Workforce
Investment System will be provided information on the past performance
of training providers to help them make career choices. The new WIA
system will be accountability-driven and all training providers must be
certified. The Workforce Investment Act also provides the authority for
a state of the art, quality information system that helps American
workers and companies navigate the labor market and exercise informed
choice in their workforce decisions. Together, these new tools will
help us respond to the demands of the changing global economy.
PAY EQUITY
Question. In his State of the Union Address, President Clinton
highlighted the issue of pay equity or pay inequity for women. We all
realize this is an important issue of fairness, however, pay inequity
for many women plagues them well beyond their working life. More women
live in poverty after the age of 65 and single women over 65 are at a
much higher risk of living in poverty. How does addressing pay equity
for women during their working life impact their economic status after
the age of 65? In addition, isn't pay equity really a family issue, not
just a women's issue? What impact does bridging the salary gap between
men and women in the workplace have on the family?
Answer. We recognize that pay inequity is not just about pay--it is
also about benefits. And although the pay and pension gap between men
and women has been narrowing, we know we must work hard to reduce it
further--and to someday see equal employment opportunity and pension
equity for all.
On average, women who work full-time earn only about 75 cents for
every dollar that a man earns. Less than 40 percent of all working
women in the private sector are covered by a pension (compared to 46
percent of men). Only 32 percent of current female retirees receive a
pension (compared to 55 percent of men). Recent (1994) men retirees'
median annual benefits were $9,600, compared with only $4,800 for
women, half the benefit amount for men.
Women's economic status after age 65 often depends on what wages
they received when they were working--and whether or not they have a
pension from their own work. If a woman has a pension but received
lower pay while working, she will face a lifetime of inequity because
most pensions are based, in large part, on wages. If a woman receives
lower wages while working and does not have a pension, she will face an
even more difficult time making ends meet when she retires. And with or
without a pension, lower wages make it harder for women to save their
own money for retirement.
The pay gap is a family issue. Women's earnings are a significant
source of family income. Women's earnings help support nearly three out
of four working American families. Yet women tend to be concentrated in
lower paying jobs. Fifty-four percent of full-time female workers earn
less than $25,000 a year compared to 36 percent of full-time male
workers. When women aren't paid equally or don't have equal access to
high-paying jobs, the whole family pays the price.
______
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Questions Submitted by Senator Arlen Specter
LOW INCOME HOME ENERGY ASSISTANCE PROGRAM (LIHEAP)
Question. Over the past several months, the price of crude oil has
increased from $10 to $30 a barrel, causing the subsequent increase of
diesel fuel, heating oil and unleaded gas. As a result of increases in
home heating fuel prices this winter, the President released all of the
emergency LIHEAP funds ($300 million) on 3 dates: January 25, February
8, and February 16. The President is requesting $600 million in
additional emergency funding in the supplemental. The President's
fiscal year 2001 request for LIHEAP is the same as last year: $1.1
billion in regular funding and $300 million in emergency funding. How
many additional families have applied for assistance? In light of the
dire situation this year, does the President's request adequately
reflect the funding needs?
Answer. LIHEAP is one of the 1981 block grants. As a result, ACF
does not have specific current information on the number of additional
families that have applied for assistance. ACF is, however, in daily
contact with their State partners to keep abreast of needs and
developments in the State LIHEAP programs. A number of States have
modified their program eligibility requirements as a result of the
large fuel oil price increases. LIHEAP funds are distributed to the
States as block grants. States have used this flexibility to leverage
emergency funds in a variety of ways to support the energy needs of low
income households, including increasing benefit levels for emergency
heating assistance for current recipients and raising eligibility
limits to serve greater numbers of households. As example, Pennsylvania
raised its maximum crisis payment from $250 to $300, provided a
supplemental payment of $250 to households already eligible under the
program (up to 110 percent of the federal poverty level), and provided
a payment of $250 to households up to150 percent of poverty. The State
also delayed the closing date for the State's crisis program from March
15 to April 30.
Fiscal year 2000 emergency funds served their function well,
addressing the needs of low income households facing significant
increases in heating costs. This year was an extraordinary situation,
which we do not expect to be repeated. However, the Administration is
seeking a $600 million supplemental appropriation for LIHEAP, to assist
families with this winter's heating bills and provide a reserve in the
event emergency summer cooling assistance is needed.
WORKER HEALTH
Question. Within the funds provided for the Agency for Healthcare
Research and Quality, the President proposes to spend $10 million for
``improving worker health.'' How does this research differ from the
research being conducted by the National Institute of Occupational
Safety and Health (NIOSH)?
Answer. The research focus at NIOSH is on the causes and prevention
of work-related illness and injury. Two components of AHRQ's proposed
worker health initiative focus on the outcomes and effectiveness of
clinical treatment and the quality of the systems in which care is
provided after a worker has been injured or otherwise becomes ill.
These two components have a focus on quality of patient care and
return-to-work that responds to research requests we have received from
the business community, labor, and major purchaser groups. The third
component of this initiative focuses on the health care workplace and
the impact of the ways we organize and manage the delivery of health
care services on the quality of patient care. This part of the
initiative builds upon past AHRQ research on the relationship between
professional staffing patterns and the quality of patient care as well
as research requests we have received from major health clinics and
hospitals in our stakeholder outreach meetings. This area of
investigation is complementary to NIOSH's work on health care worker
health and safety. AHRQ and NIOSH have collaborated effectively on this
issue and will continue to do so in the new initiative. This initiative
will help employers ensure that injured workers receive quality health
care.
HEALTH CARE ACCESS FOR THE UNINSURED
Question. The President is requesting $125 million for an
initiative he calls ``Health Care Access for the Uninsured.'' It
appears that your request requires authorizing legislation before
Congress can appropriate funds. Please explain how this program would
work and the goals that the administration hopes to achieve.
Answer. In fiscal year 2000 Congress appropriated $25 million for
the Health Care Access for the Uninsured program which we are operating
under Section 330 demonstration authority of the Public Health Service
Act. In order to strengthen the program the Administration provided
Congress with the draft bill, ``Community Access to Health Care Act of
2000'' on March 22, 2000. The Community Access Program (CAP), included
in our budget request as the Health Care Access for the Uninsured
program, is an innovative effort to help communities build and
strengthen integrated health care delivery systems for uninsured and
underinsured persons. The health care services available to the
uninsured can be fragmented, often with little to no coordination among
providers who serve this population. Not only can patient care be
compromised, but much-needed resources can be wasted as providers
duplicate efforts. CAP addresses this growing problem by fostering
community-based efforts to improve service integration for the
uninsured. Building off the critical foundation established by
providers who have traditionally provided services without regard to
ability to pay, CAP will provide new resources to help communities
coordinate core services more effectively. CAP grants will support the
development of infrastructure, such as information systems, referral
relationships, and clinical protocols, that will help providers improve
access to existing services and promote the efficiency of the care that
is delivered. By supplementing existing categorical programs to fund
safety net services and targeting infrastructure development not
currently supported through those programs, CAP will allow communities
to better harness their current capabilities and resources.
CAP is designed to encourage community-wide collaboration and
stimulate creative approaches to the development of coordinated,
comprehensive care systems. CAP recognizes that the ``safety net'' of
providers willing to deliver care to the uninsured can vary from
community to community, resulting in a wide array of integration
challenges. To accommodate this variability and to promote innovation,
CAP is intended to be flexible to community needs. No single model for
integration is being promoted; rather it is our goal that a diversity
of models be explored. While the methods used to achieve integration
may differ, all CAP grantees will represent community-wide coalitions
focused on developing sustainable infrastructure for improved services
integration.
FAMILY CAREGIVER PROGRAM
Question. Last year, the President requested $125 million for a
``Family Caregiver Program.'' Congress did not appropriate funds
because this program was not authorized. You are requesting the same
level of funding this year. Do you believe that you can undertake this
program without authorizing legislation?
Answer. Yes, Title III-D of the Older Americans Act provides
existing authority to support caregivers. As we look at the needs of
our older population we become more and more cognizant of the needs of
their caregivers. Establishment of the National Family Caregiver
Support Program, through reauthorization of the Act, has the advantage
of providing the kind of visibility we would like for this program, and
would probably afford a better opportunity to systematize the services
we are suggesting need to be put into a package. However, Existing
authority will permit us to do the work that is essential to intervene
immediately. We will continue our efforts to seek reauthorization of
the Older Americans Act and the formal establishment of the National
Family Caregiver Support Program.
MEDICAL ERRORS
Question. Last week, the President issued his recommendations for
reducing medical errors, following the Institute of Medicine's report
``To Err is Human: Building a Safer Health System.'' The President has
requested $20 million to reduce medical errors. Is this investment
significant enough, given the fact that medical errors cause up to
100,000 deaths annually? How long do you think it would take to
accomplish your goals to truly see a reduction in the rate of medical
errors?
Answer. The recommendations you refer to are much broader than
HHS--they also address work needed in other agencies involved in health
care and health coverage, such as the Department of Defense, The
Department of Veterans Affairs, the Office of Personnel Management, and
the Department of Labor. Our budget includes increases of $33 million
to start this work. An increase of $20 million is requested in the
Agency for Healthcare Research and Quality (AHRQ). AHRQ will create a
Center for Quality Improvement and Patient Safety which will carry out
a wide range of research activities to reduce medical errors. An
increase of $13 million is requested in the Food and Drug
Administration to reduce medical errors related to adverse events from
FDA-regulated products, as well carry out a wide range of activities
recommended by both the Institute of Medicine and the Quality
Interagency Coordinating Task Force (QuIC), which I co-chair. In
addition to activities for which dedicated funding is requested, HCFA
will require that hospitals implement medical error reduction and
patient safety programs to meet Medicare's conditions of participation.
These activities, combined with other work recommended by the QuIC,
will give us a good start on the work of reducing medical errors.
YOUTH VIOLENCE
Question. On February 25, Bruce Reed sent a letter describing the
Administration's progress on instituting the youth violence prevention
initiative. What specific ways will you encourage HHS agencies to
coordinate with the Department of Labor and the Department of Education
to ensure the coordination of efforts to reduce youth violence?
Answer. In developing the Youth Violence Prevention Initiative, our
efforts extend across Department lines. A Federal Coordinating
Committee on the Prevention of Youth Violence has been convened, which
includes representatives from the Department of Labor, Justice and
Education. This committee is assessing the cross-cutting issues in
violence among youths and is exploring ways on how to synchronize and
maximize our collective efforts into a meaningful blueprint of an
effective initiative.
The Department of Health and Human Services is already working
closely with the Departments of Education and Justice to continue
coordination of the Safe Schools/Healthy Students initiative begun in
fiscal year 1999. The Safe Schools/Healthy Students is an unprecedented
collaborative effort to assist communities in designing and
implementing comprehensive educational, mental health, social service,
law enforcement and juvenile justice services for youth. Our efforts in
this collaboration, through the Substance Abuse and Mental Health
Services Administration's Center for Mental Health Services, have
resulted in the funding of 54 grants to school districts around the
country. While no increase in funding is requested for SAMHSA, the
overall President's fiscal year 2001 Safe Schools/Healthy Students
budget request includes funding for an additional 40 grants, and would
include the Department of Labor as a new partner in this effort.
CDC, and the U.S. Department of Education, Department of Justice,
and the National School Safety Center continue to examine homicides and
suicides associated with schools and identified common features of
school-related violent deaths. The study examines events occurring to
and from school, as well as on both public or private school property,
or while someone was on the way or going to an official school-
sponsored event. The first study looked at deaths occurring during
1992-1994. CDC and its partners are updating and expanding the original
study, examining school-associated violent deaths since July 1994.
In addition, the Office of the Surgeon General is developing a
``Surgeon General's Report on Youth Violence'' that will be completed
this year. Information and assistance is being obtained from HHS
operating divisions, other Federal Departments such as Education,
Justice and Labor, communities, private organizations, academia, State
and local governments, and other groups to ensure the report soundly
addresses the prevention of youth violence as a collaborative
intervention requiring a well-coordinated approach.
MEDICARE COVERAGE OF INJECTABLE DRUGS AND BIOLOGICS
Question. When will HCFA issue a program memorandum to carriers as
required by the report language accompanying Section 219?
Answer. The program memorandum (AB-00-21) was issued on Friday,
March 17, 2000.
Question. What is the status of the policy conveyed in the
transmittal of August 13, 1997 of the Deputy Director of the Division
of Acute Care to regional offices regarding injectable drugs?
Answer. We have directed our contractors to disregard the
memorandum and all other documents based on that memorandum until
further notice. Contractors are to base any determinations they make
with respect to self-administered injectable drugs on policies that
pre-existed that memorandum.
Question. I am concerned that some carriers may consider the August
13, 1997 transmittal to be the current Medicare policy on injectable
drugs. Can you assure me that, today, it is Medicare's policy among all
carriers to cover injectable drugs for program beneficiaries if the
physician determines that it is inappropriate or impossible for a
particular patient to self-administer the drug?
Answer. In accordance with the DHHS Appropriations Act, 2000
requirements, we have suspended the August 13, 1997 memorandum and have
instructed our contractors to make determinations with respect to self-
administered injectable drugs based on policy guidance that pre-existed
that date. This law also effectively precludes us from clarifying our
policy, since any clarification could easily be read as restrictive;
therefore, our contractors are making determinations based on policies
in place prior to August 13, 1997. While our contractors will be acting
independently, I can say that historically they have not been inclined
to provide coverage for injectable drugs that can be self-administered.
______
Questions Submitted by Senator Ernest F. Hollings
LIVER ALLOCATION POLICIES
Madam Secretary, I'm a bit confused by the Department's December 21
Federal Register notice, and was wondering if you could clarify your
understanding of the moratorium imposed on the OPTN Final Rule by
Section 413 of the Ticket to Work and Work Incentives Improvement Act
of 1999.
The Amended Final Rule would have required the OPTN to submit
revised liver allocation policies by February 15, 2000--88 days after
the Rule was to become effective on November 19, 1999. But Section 413
imposed a moratorium on the effective date and all provisions contained
in the Amended OPTN Final Rule Until March 16, 2000.
The Department's December 21 notice states on page 91626: ``Because
we do not seek to have the deadline occur during the period when the
regulation is stayed, we have decided to extend the deadline to March
16, 2000''--just 30 days after the original deadline, and the first day
the Rule can become effective under the moratorium.
Question. Could you please explain to me why requiring the OPTN to
work on the most controversial new allocations policies required by the
Rule during a period when its implementation has been stayed by
Congress does not violate both the spirit and the letter of the
moratorium?
Answer. The OPTN has been working on the refinement of the liver
allocation policy continuously since the NPRM was published in 1994. We
did not believe it was wise to interfere with their deliberations. Nor
did we believe it was wise to suggest that the patients could wait for
the benefits of an improved liver allocation system. The OPTN delivered
a liver allocation policy proposing wider sharing for patients with the
most urgent need and plan for further refining the medical distinctions
among chronically ill patients on March 15, 2000. The Department is
reviewing that submission. I believe it is a reflection of the OPTN's
efforts to address the problem and a testament to the Department's
persistence that a policy that puts patients first was delivered on
time.
Question. Section 413 also requires the Department to solicit and
review comments on the Rule, and to revise it appropriately in
accordance with this review. How, then, can you justify your December
21 Federal Register notice, which announced a March 16, 2000 effective
date for the rule, when you had not even begun to receive, much less
review, comments on your October amendments? What kind of message do
you think this sends to those who will be so deeply affected by the
provisions of this Rule?
Answer. We were confident that our staff could review the comments
and identify any new issues that would require modifications to the
rule quickly. In fact, no new issues were raised by the public comments
and no change was needed. A Federal Register Notice so stating was
published March 21, 2000.
Question. Do you plan to revise the Rule based on public comments?
If so, what is your time frame? Why wouldn't you postpone the effective
date until you make the additional modifications? If you do not plan to
modify the regulation, why not?
Answer. We were confident that our staff could review the comments
and identify any new issues that would require modifications to the
rule quickly. In fact, no new issues were raised by the public comments
and no change was needed. A Federal Register Notice so stating was
published March 21, 2000.
______
Question Submitted by Senator Daniel K. Inouye
HEALTH CENTERS WAIVERS
Secretary Shalala, On April 20, 1998, HCFA sent a letter to State
Medicaid Directors requiring States with Section 11 15 waivers to
comply with the terms and conditions of their waiver as they relate to
federally qualified health centers. In this letter, HCFA committed to
review those States' compliance with the waiver and to take corrective
action if necessary.
Madame Secretary, it has been nearly two years since that policy
was released and it is my understanding that States with Section 11 15
waivers are still not complying with the terms and conditions
specified. This has created a very serious problem in my state costing
Hawaii health centers $1.2 million a year as a result of this non-
compliance.
Question. What is the Department's plan to take corrective action
regarding this problem and when do you plan to implement this course of
action?
Answer. On July 15, 1998 HCFA sent a letter to all State Medicaid
Directors with the section 1115 waiver of cost-based reimbursement for
federally qualified health centers (FQHCs). This letter requested that
each State submit information pertaining to the methodology used to
reimburse FQHCs under their section 1115 demonstrations. The submitted
information was to include an analysis of how the methodology was
developed to calculate a cost-related or risk-based adjustment, as well
as a description of how the methodology was implemented.
We received the State responses and on September 30, 1998 we wrote
to the Primary Care Association (PCA) in each State in order to share
the State response and to request that the PCA review the response. We
asked each PCA to provide us with their assessment of the State
response as well as any comments they wished to provide on the adequacy
of the State's methodology for meeting the FQHC term and conditions.
On January 4, 1999 we sent a follow up letter to seven States,
including Hawaii, requesting further information and clarification of
their methodology. We received all of the State responses by May 1999.
Since that time we have worked in partnership with the Health Resources
and Services Administration to assess the State and PCA responses. We
expect to be in contact with the Hawaii regarding this assessment
shortly.
______
Questions Submitted by Senator Patty Murray
BATTERED WOMEN AND CHILDREN
Question. I would like to focus my questions on my concerns
regarding the impact of welfare restructuring on battered women and
children, who are some of the most vulnerable citizens. Secretary
Shalala, as you are aware, I fought to implement a ``family violence
option'' within Federal welfare guidelines. My objective was clear--to
make clear that punitive welfare restrictions did not result in more
women and children becoming trapped in violent homes or relationships.
I feel confident that the final regulations issued by HHS for the
States to implement a family violent option will meet my objective.
However, I have become increasingly concerned that States are not
screening properly and are not directing services and benefits to
battered women. Can you briefly outline what steps you are taking to
ensure that battered women do not end up being victimized by our
welfare structure and do we have any real outcome data on the number of
battered women impacted? How many of those who have fallen off welfare
are now trapped in violent homes or relationships?
Answer. The Department's Administration for Children and Families,
Office of Family Assistance has a number of initiatives that address
domestic/family violence.
In fiscal year 1997, a grant was awarded to the Anne Arundel County
Department of Social Services, Maryland to develop and pilot test a
domestic violence training curriculum for administrative and front line
service staff. The training model developed in collaboration with the
YWCA of Annapolis (Maryland) is intended to better equip staff to
identify and serve clients of TANF and other public assistance programs
who may be victims of domestic violence. New staff receives training on
how to identify and screen for potential domestic violence situations.
Anne Arundel County was awarded a subsequent grant in fiscal year
1998 to increase its capacity to provide technical assistance to human
service agencies on integration of services and organizational change.
The organizational change model included strategies to assess and
provide services to families at risk of domestic violence, and other
barriers to self-sufficiency.
Anne Arundel County Department of Social Services like many local
welfare offices places information in public restrooms about domestic
prevention services and hotline telephone numbers.
ACF has funded our Regional Offices to provide targeted workshops
around domestic violence issues such as identification, screening,
confidentiality, and safety planning. A major conference is planned for
our Northeast Hub (Regions I-III) in August of this year.
ACF's Office of Community Services funds the National Family
Violence Hotline, which provides assistance to families in immediate
danger of violence, and provides grants to community organizations for
Family Violence Prevention Services.
The Department has an ongoing Family Violence workgroup composed of
senior staff from its operating divisions who coordinate DHHS program
policies and activities to provide education on domestic violence
prevention and services.
With reference to outcomes, as of February 2000, we are beginning
to receive detailed quarterly data from states on individuals receiving
TANF assistance. We will not have outcome data on battered women, but
we will know the number of women who are exempt from the work
requirements based on receipt of a domestic violence waiver.
In addition to these cooperative efforts, DHHS and DOL convened a
series of conferences to share with other welfare reform stakeholders,
an informational ``road map'' on how to succeed in moving welfare
families to self-sufficiency. The information presented included models
of promising practices for helping families move from welfare to work.
The conference objectives were to help participants:
--gain insight on how agency practitioners and the private sector
have responded to challenges of moving welfare recipients to
work;
--learn from practitioners how to prepare for the difficult task of
moving welfare clients with multiple barriers to work;
--interact with peer practitioners from a broad cross-section of
Federal, State and local agencies, community-based
organizations, employers, and other disciplines; and
--gather practical information, helpful practices, and names of
professional contacts to help structure programs to move
families to self-sufficiency.
CHILD CARE
Question. One of the greatest challenges to meeting welfare-to-work
goals is child care. I have listened to this Administration and many
Governors talking about the success of welfare restructuring. However,
there has been little action at the state level to increase the
availability of affordable, quality child care, especially infant care.
We know that early childhood development is essential, yet I am not
convinced that we are targeting limited resources to implementing new,
innovative child care programs. I know the President is calling for
additional resources. I=d like to know B what are we doing to ensure
that parents, especially those caught between work and welfare, can
locate quality, affordable child care?
Answer. A recent report, Access to Child Care for Low-Income
Working Families, found that in an average month in fiscal year 1998,
only 10 percent of the 14.7 million children eligible for child care
subsidies under Federal regulations received them. The fiscal year 2001
budget request includes several proposals to help low-income families
find and afford quality child care. For fiscal year 2001, we are
requesting $2 billion, an increase of $817 million, for the
discretionary Child Care and Development Block Grant (CCDBG). These
funds are critically needed to help address the gap between available
funds and the child care subsidy needs that low-income working families
re experiencing. This increase will provide child care subsidies to
nearly 150,000 additional children. $223 million of the total funds
requested will support State activities that improve the quality of
child care, including $50 million for infant and toddler quality
activities and $19 million for school-aged care and resource and
referral activities.
In addition, the budget includes $600 million in entitlement funds
for an Early Learning Fund to focus on the quality of child care. The
Early Learning Fund will be used to provide grants to communities to
improve school readiness by fostering the cognitive, physical, social
and emotional development of children under five years-old through
improvements in the quality of child care settings, among other things.
The President=s budget also proposes an increase in the Child Care and
Dependent Care Tax Credit (DCTC) of $7.5 billion over 5 years and an
expansion of the Earned Income Tax Credit (EITC) of $23.6 billion over
10 years, both of which would help low-income working families obtain
quality, affordable child care.
______
Questions Submitted by Senator Larry Craig
Question. Is the Federal Center for Substance Abuse Prevention part
of the Substance Abuse and Mental Health Services Administration or
SAMHSA?
Answer. Yes, the Center for Substance Abuse Prevention (CSAP) is
part of the Substance Abuse and Mental Health Services Administration
(SAMHSA).
Question. A survey was sent out to Missourian students in grades 6,
8, 10, and 12 by the State of Missouri, and funded by the Federal
Center for Substance Abuse Prevention, for the purpose of participating
in a study designed to ``develop important information that will help
combat such problems as alcohol and other drug use in our schools and
communities.'' If the states purpose of the SAMHSA sponsored survey is
to help combat alcohol and drug use problems, then why do 10 percent of
the questions deal with handguns?
Answer. This survey was conducted as part of a Missouri needs
assessment contract. Needs assessment provides a means for States to
obtain data critical for prevention planning, resource allocation, and
to establish baselines for performance measurement. States are
collecting uniform data through school and community resource studies
and assessing risk and protective factors in four domains--Peer/
Individual, Family, School, and Community--using readily available
surveys, including the CSAP Student Survey Risk and Protective Factors
Instrument, the Youth Risk Behavior Assessment Survey (CDC) and/or
other community-based instruments
To assist States with needs assessment, CSAP contracted with
Hawkins, Catalano, and Miller to help develop a survey instrument.
Hawkins et al. worked with a six state consortium (WA, OR, CO, ME, KS,
and UT) to develop the Student Survey and pilot it. CSAP and ONDCP
assessed the viability of the Student Survey among the first 3 cohorts
(11 out of 23 states, or 48 percent) and determined that the Survey was
an accurate needs assessment instrument. Discussions with the ONDCP
regarding the State needs assessments determined that these assessments
would be of more value if we could compare the data gathered for one
State to the data of other States. Since the Student Survey is a
reliable needs assessment instrument, the Survey was designated as a
mandatory instrument for subsequent needs assessments. Based on this,
Missouri is required to use this instrument. States that have, or are
scheduled to use the Student Survey include: Washington, Florida,
Kansas, New Jersey, South Carolina, Maine, Utah, Oregon, Arkansas,
Delaware, Montana, Arizona, Hawaii, Missouri, Virginia, Alabama,
Michigan, and Tennessee. Three states also using the survey, but not as
part of the CSAP needs assessment are: Louisiana, Kentucky, and
Pennsylvania. NIDA also is using the Student Survey in communities as
part of a seven state consortium diffusion study.
Research has consistently shown a strong association between
substance use and violence. This is reflected in studies depicting
violence as a precursor to substance abuse (by victims of violence) as
well as depicting substance use as a precursor to violence (by
assailants). The Student Survey, in use since 1993, includes questions
related to individual, peer, family, and community antisocial behavior
because of this consistent relationship. Student survey results from
both a CSAP six state consortium and the National Institute on Drug
Abuse (NIDA) seven state consortium further support this relationship.
The handgun questions, which comprise 5.2 percent of the survey,
are part of scales that measure:
--association with antisocial peers
--early initiation of problem behavior
--attitude toward antisocial behavior
--antisocial behavior
--convention involvement
--perceived availability
--community laws and norms
--family history of antisocial behavior
NIDA study data show that every one of these constructs is strongly
correlated with 30-day substance use as well as with antisocial
behavior. Hence, the survey scales are important for identifying risk
factors that potentially should be targeted within a State program.
______
Questions Submitted by Senator Robert C. Byrd
STATUS OF REPORTS
Question. On December 9, 1999, I wrote to your office to inquire as
to the status of certain initiatives identified in Senate Report 106-
166 accompanying the fiscal year 2000 Departments of Labor, Health and
Human Services, and Education, and Related Agencies Appropriations bill
and/or Conference Report 106-479 accompanying the Consolidated
Appropriations bill. I respectfully ask you to provide me with a status
report of the following projects:
$38,500,000 and 303 full-time equivalent employees for the new National
Institute for Occupational Safety and Health laboratory in
Morgantown, West Virginia; (CDC)
Answer. The investment in the new National Institute for
Occupational Safety and Health (NIOSH) laboratory in Morgantown, West
Virginia, continues to yield significant scientific advances in
understanding and preventing work-related disease, injury, and death.
Activities at the new laboratory include: applied and preventive,
multi-faceted laboratory-based research into the causes, mechanisms,
prevention, and control of occupational disease and injuries; the
development of high-tech engineering solutions for the control of
occupational hazards; and basic and applied health communications
research to improve the effectiveness of NIOSH communication efforts.
Highlights of the laboratory's fiscal year 1999 accomplishments
include:
--Hexavalent Chromium Research.--NIOSH researchers developed a field-
portable method for on-site determination of hexavalent
chromium (a carcinogen found in structural components of
buildings, as well as ink, paint, textile dyes, graphic art
supplies, and wood preservatives), which is critical for
assessing worker exposure and the effectiveness of control
measures. Additional NIOSH basic research is examining the
mechanism of hexavalent chromium-induced carcinogenesis.
--Modeling Silica Exposure.--NIOSH investigators performed a silica
inhalation study using animal models to examine pulmonary
damage, pulmonary inflammation, fibrosis, and dust retention.
The study found explosive increases in lung damage and
inflammation when dust burdens stabilize, and observed that
inflammation progressed even in the absence of continued
exposure. The data will be used to model dust deposition,
clearance, and retention in rats and to compare results to
models for humans.
--Carcinogenesis Mechanisms for Cadmium.--NIOSH studied the molecular
mechanisms responsible for tumorigenic potential of cadmium.
Findings suggest that genetic instability and changes in the
cancer-related and novel genes may be responsible for the cell
transformation and tumorigenesis induced by these metals.
Identification of mechanisms for workplace-related
carcinogenesis will help identify appropriate strategies for
therapeutic intervention and prevention, as well as improve
risk assessment for carcinogens.
--Laboratory-based Models for Work-related Stress.--To determine the
role of acute and chronic stress as occupational risk factors
or contributors to disease, NIOSH is working with external
partners to use laboratory-based models to determine the
biochemical, cellular, and molecular changes engendered by
specific stressors alone and in conjunction with various
disease models. Results from this work indicate that
glucocorticoid release associated with stress enhances skin
response to chemicals and can exacerbate damage in the brain
areas important for cognition.
--Silicosis Outreach for Hispanic and Latino Workers.--NIOSH is
developing an outreach project to increase the awareness of the
seriousness of silica exposure among construction workers in
Texas (who experience an alarming number of deaths attributed
to silicosis) and to increase the use of engineering controls
and respiratory protection in these workers. NIOSH assessed the
workers' knowledge, beliefs, and behaviors about silicosis
prevention, as well as their information seeking habits and
barriers to and facilitators of prevention. NIOSH is using
these data to develop a silicosis prevention program in fiscal
year 2000.
--Preventing Deaths from Tractor Overturns.--Tractor overturns are
the largest single source of agricultural fatalities,
accounting for approximately 132 deaths per year. Current
rollover protective structures (ROPS) do not provide adequate
protection because farmers manually lower them when working in
low clearance areas and may forget to raise them. NIOSH has
developed a ROPS prototype that is stored normally in a compact
form but automatically deploys to full dimension, without
operator input, to protect the operator in the event of an
overturn. The new system includes: (1) a roll bar and
deployment mechanism, which were successfully tested for
appropriate protective strength according to industry
standards, and (2) a sensor to identify an impending overturn
and trigger the roll bar deployment. A patent application is
being developed for this device.
Research at the new laboratory will continue to focus on critical
areas in occupational safety and health in fiscal year 2000. For
example, researchers at the new laboratory are: coordinating an
Institute-wide intramural initiative to study allergic and irritant
dermatitis, including latex allergy, using state-of-the-art research
methods; studying the genetic mapping of lung and prostate cancer to
aid in the identification of at-risk worker populations; and using
virtual reality technology to study the prevention of falls, which are
one of three leading causes of injuries occurring in the workplace.
$3,000,000 for the construction of West Virginia University's Eye
Center; and $1,1135,000 for the construction and equipment of
the Harts Health Center in Harts, West Virginia
Answer. Congress provided $120 million for eighty-six specific
projects in fiscal year 2000 and this amount has been reduced to $112.4
million under the fiscal year 2000 government-wide discretionary
spending rescission authority. The projects at the West Virginia
University's Eye Center and the Harts Health Center in Harts, West
Virginia will be notified in April 2000 of the amount available for
their specific project and they will be provided with an application
kit and application guidelines. They will be given 60 days to submit
their application and supporting documentation. Following a 75-day
review period, given the large number of projects, grant awards are
scheduled for the end of September 2000.
Approximately $1,000,000 for West Virginia University's Prevention
Center funded through the Centers for Disease Control and
Prevention; (CDC)
Answer. In fiscal year 1994, West Virginia University received a
four-year Prevention Research Center (PRC) grant from CDC. Under this
cooperative agreement, they received approximately $1,000,000 per year
in core funding.
In fiscal year 1998, at the end of West Virginia's 4-year project
period, they competed for renewal of their core PRC cooperative
agreement along with the other 13 PRCs which existed at the time. In
fiscal year 1998, CDC approved a 12-month extension of the project to
allow the PRC time to expend their remaining funds to complete program
goals and objectives.
CDC's fiscal year 1999 appropriations committee report language
mandated that all ``incumbent'' PRCs were to be funded. Based on this
language, CDC awarded West Virginia a new 5-year PRC cooperative
agreement, which began on February 1, 1999. The fiscal year 1999 award
amount for the first year of this new 5-year project period included
$600,000 in new core funds, which was commensurate with the level of
funding received by the other 13 incumbent PRCs. The award also
included $133,611 in new supplemental funds, and $285,000 in funds West
Virginia withheld in previous years, for a total approved amount of
$1,018,611.
In fiscal year 2000, the West Virginia PRC received $650,000 in new
core funds to support the second year of the current project period,
which began on February 1, 2000. This increase in core funding was
equal to the funding level of the other incumbent centers. They will
also again have the opportunity to request funding for continuation
projects and compete for new special interest project funding this
year.
Current center activities include evaluating the efficacy of a new
teen smoking cessation program, Not on Tobacco, in two Appalachian
states. Other research projects focus on diabetes, cardiovascular
disease, nutrition, tobacco, and mental health. The Center continues to
be the Coordinating Center for the Women's Cardiovascular Health
Network and participates in the Tobacco Control Network. The Center
also provides participatory research training to West Virginia Bureau
for Public Health funded projects and has strong relationships with the
West Virginia Department of Education, the American Lung Association,
other voluntary health organizations, and other community-based groups.
$687,000 for Marshall University's Autism Training Center; (CDC)
Answer. CDC will encourage Marshall University to broaden its
intervention program to include secondary conditions in children with
autism as well as to examine etiologic factors and conduct surveillance
for the condition.
$850,000 for the Farm Resource Center through the Center for Mental
Health Services of the Substance Abuse and Mental Health
Services Administration
Answer. SAMHSA will announce the availability of a demonstration
grant program in April 2000. The Rural Outreach Program demonstration
would continue outreach activities that ameliorate stress associated
with unemployment in rural communities and increase access to, and
utilization of, mental health and substance abuse services for coal
miners, farmers, and their families in Illinois and West Virginia and
western Pennsylvania. This program, designed to result in more
effective mental health and substance abuse services delivery, is
intended to address the needs of adults and their families in rural
areas who have or may be at risk for developing a mental illness or
substance abuse problem. Needs of their children who have or may be at
risk for developing emotional or other behavioral problems are
addressed also.
Report language and $500,000 for the Office of the Surgeon General, in
conjunction with the Public Health Policy Board and other
agencies, to establish a process for selecting health
priorities based on clear scientific data on emerging health
threats to children
Answer. The final fiscal year 2000 appropriation did not include
funding to establish a process for selecting health priorities.
However, in January 2000 the Surgeon General launched Healthy People
2010, the third iteration of the Healthy People initiative first
launched in 1979 with the publication of Healthy People: The Surgeon
General's Report on Health Promotion and Disease Prevention. Healthy
People 2010 sets the nation's health agenda for the next decade and
states a set of common goals developed through a national consultative
process; it also provides a mechanism to monitor progress toward
achieving those goals. The scope of the Healthy People initiative has
grown over the last three decades to more than 460 objectives--about a
third of which relate to children. This approach identifies important
public health issues for children and families, and assesses the
relevant science available on these topics, in order to stimulate
public discussion and effective interventions. The multidisciplinary
and broad public health expertise of the Public Health Policy Advisory
Board has taken a similar approach. Dr. Louis W. Sullivan, the current
Chairman & CEO of the Public Health Policy Advisory Board, was among
the distinguished leaders who participated in the release of the
Healthy People 2010 Report. Healthy People 2010, which now includes a
set of ten leading health indicators, has provided a monitoring
apparatus to measure and achieve progress towards our child health
goals.
Report language urging the Surgeon General to host a summit on obesity
policy to develop a national strategic plan to prevent obesity
and to complete the Surgeon General's Report on Nutrition and
Health which was to focus on dietary fat
Answer. The Surgeon General is very concerned about the increasing
health burden of obesity and overweight, and has considered how best to
contribute to its alleviation. Towards this end, HHS and the U.S.
Department of Agriculture (USDA) are jointly planning a National
Nutrition Summit for May 30-31, 2000, that will have a major focus on
overweight and obesity. This summit will highlight: accomplishments in
food, nutrition, and health that have occurred since the 1969 White
House Conference on this topic; the continuing challenges and emerging
opportunities in this area; and nutrition and lifestyle issues across
the human lifespan, especially those that we confront in solving the
nation's epidemic of overweight and obesity. The summit will include
policy makers, leading researchers in obesity, nutrition, physical
activity and community-based prevention, and representatives of
consumer, trade, business, and health professional organizations. An
HHS/USDA interdepartmental steering committee is coordinating the
summit, and held a public meeting in December 1999 to solicit input on
the agenda. The committee will continue to solicit input and to involve
other relevant government agencies in its planning efforts.
As a follow-up to the 1988 Surgeon General's Report on Nutrition
and Health, and to fulfill the requirements of Public Law 103-183, a
Surgeon General's Report on Dietary Fats and Health was being developed
under the aegis of the Department's Nutrition Policy Board. However, it
became clear to the report drafters that, while the role of dietary
fats (especially saturated fats) in coronary heart disease is well
established, the science related to dietary fat intake and other
chronic diseases is still evolving--and has become increasingly complex
and, in some cases, contentious. There is also emerging evidence that
energy balance is a key dietary factor affecting health and disease
risks, independent of the effects of fats. Because dietary fats are a
component of energy intake, it is difficult to parse the effects of fat
or types of fat on disease risk and energy intake per se.
Therefore, in order to obtain the balanced review needed to address
this issue, the Office of Public Health and Science turned to the
Institute of Medicine (IOM). In the fall of 1999, IOM began a 24-month
comprehensive review of macronutrients with dietary fats and health,
and including energy balance as a major component. This review is part
of the IOM's multi-year project to evaluate nutrient requirements and
establish recommended dietary intakes. Several other significant
reviews with relevance for dietary fat and health issues parallel the
IOM study; these include: a National Cancer Institute-funded systematic
review and synthesis of the research literature concerning diet-related
behavior change interventions; a Rand Corporation study funded by the
Centers for Disease Control and Prevention on healthy aging, which will
include diet, nutrition, and fat; and the National Cholesterol
Education Program's expert panel review of current detection,
evaluation and treatment methods for high blood cholesterol. As these
reports are finalized, the science related to dietary fats will be
better understood, and the Department will be better able to take
appropriate action to promote and protect public health.
Report language under the National Institute on Alcohol Abuse and
Alcoholism regarding Fetal Alcohol Syndrome (FAS), genetics,
neuroscience, medications development, alcohol and Hepatitis C,
alcoholic liver disease, and ``Research to Practice'' Forums
Answer. Fetal Alcohol Syndrome (FAS)--FAS research at NIAAA is
supported in both the intramural and extramural programs and accounted
for approximately 6.7 percent of the Institute's budget in fiscal year
1999. Prevention of FAS is a high priority for the Institute. All
meritorious candidates submitted in response to a recent request for
applications have been funded. Research continues in a large community-
based trial of comprehensive interventions to prevent FAS and other
alcohol-related birth defects among four Plains Indian tribes, with two
other Native American communities serving as comparison sites. A
project to develop a screening tool and determine the prevalence of
drinking in women in prenatal clinics in the District of Columbia also
was cosponsored by the National Institute of Child Health and Human
Development (NICHD). Data collection now has been completed, and data
analysis is under way.
To aid the health care community in addressing the problem of FAS,
the NIAAA has developed two manuals for use in clinical practice. These
manuals soon will be ready for distribution. One is designed to train
health practitioners who treat women of childbearing age on the
assessment of risk drinking and on referral and intervention methods.
The other provides a guide for pediatricians on screening children for
FAS. The NIAAA plans to pilot test the effectiveness of both manuals
with primary care health professionals. In addition, the NIAAA is
preparing a Request for Proposals to establish a FAS clearinghouse.
The NIAAA will continue its leadership of the Interagency
Coordinating Committee on Fetal Alcohol Syndrome (ICCFAS). Member
organizations include seven organizations within the U.S. Department of
Health and Human Services (DHHS), the Office of Special Education in
the U.S. Department of Education (DoED), and the Office of Juvenile
Justice and Delinquency Prevention in the U.S. Department of Justice
(DOJ). To promote information exchange and to assure high quality
research, the NIAAA sponsored an investigator workshop at the October
1999 ICCFAS meeting.
--Genetics--Approximately 50-60 percent of total population
vulnerability to alcoholism is mediated by genetic factors. The
NIAAA-funded Collaborative Study on the Genetics of Alcoholism
(COGA) has found significant evidence for genetic linkages on
several chromosomes. These chromosomal regions are likely to
contain genes that influence alcohol-related behavior. This
powerful new data set generated by COGA is now ready for
release to the general scientific community. The COGA databases
contain extensive clinical, diagnostic, psychological,
neurophysiological, pedigree, and genetic data on thousands of
individuals, who comprise hundreds of families of alcoholics
under study. The neurophysiological data will be distributed by
SUNY Downstate Health Sciences Center (New York, NY); all other
data will be distributed by Washington University (St. Louis,
MO). The companion collection of cell lines and DNA samples
from individuals studied will be distributed by Rutgers
University (Piscataway, NJ). The Institute plans to encourage
intensive analysis of the substantial COGA data set by the
broadest possible spectrum of investigators.
--Neuroscience--Approximately 25 percent of the NIAAA's resources are
committed to neuroscience research. Recent neuroscience
findings on the biologic mechanisms that underlie alcohol's
effect represent new possibilities for development of
medications for alcohol disorders. Most pharmaceuticals target
specific protein sites. Scientists have identified at least one
protein site on a neuroreceptor implicated in alcohol's
neurodepressant actions, opening the potential for design of
compounds to block such protein sites and, thus, alcohol's
effects. In response to these and other findings, the Institute
has solicited research grants for the study of in vivo
screening models that will test new compounds for alcoholism
pharmacotherapy. Another initiative solicits research that will
examine how alcohol affects neurochemical changes that take
place during adolescence.
--NIAAA-supported scientists are using and expanding powerful new
techniques for studying specific protein areas of
neuroreceptors. Site-directed mutagenesis and chimeric
techniques permit researchers to examine, individually,
components of neuroreceptor proteins to determine if they are
involved in the brain's response to alcohol. Gene knock-out
techniques eliminate the activity of specific genes and the
proteins they encode. These genetic techniques thus allow
scientists to test whether specific proteins, including
components of neuro-
receptors, mediate alcohol's effects on nervous system
function. The NIAAA will issue a Request for Applications (RFA)
to apply these techniquest to alcohol studies in fiscal year
2000. In addition, NIAAA-funded investigators are among the
pioneers of a microdialysis technique that enables researchers
to directly measure--simultaneously--neurotransmitter and
neurophysiologic response in freely-behaving rats exposed to
cognition-altering substances.
Based on these neuroscience finding, NIAAA-supported scientists
are developing new pharmacologic compounds. Grants awarded
under the pharma-
cotherapy-screening initiative will enhance the laboratory
testing process for evaluating the therapeutic potential and
likelihood of risk associated with these substances. Once this
screening task has been accomplished, promising compounds will
follow the usual route in the medication-development pipeline;
namely, testing for efficacy and safety in animal studies, then
small-scale human trials, when appropriate. Compounds shown to
be safe and effective in small-scale human trials will then
become candidates for large-scale human clinical trials.
--Medications Development--NIAAA-supported scientists are making
rapid progress in understanding the neurobiologic mechanisms
that underlie alcohol's effects. With this understanding comes
the potential to design compounds that therapeutically alter
these mechanisms. To channel this rapid accumulation of data
toward medication development, the NIAAA is encouraging
research grant applications that will result in new methods of
screening promising compounds with therapeutic potential. This
screening initiative also includes a component intended to
stimulate research on pharmacotherapy for the sequelae of
alcoholism, such as liver disease.
--Project COMBINE, a large, multi-site, clinical trial of promising
alcohol-treatment medications--naltrexone and acamprosate--is
ongoing. Investigators are testing the effectiveness of these
medications alone and in combination. The medications are being
evaluated with two behavioral interventions which are
applicable to two types of treatment settings. One is
applicable to primary care medical practices, and the other is
suitable for addiction medicine speciality practices.
Preliminary studies evaluating safety of the combination of the
medications and the feasibility of the study protocol are in
progress, and the main trial will begin early in year 2000.
--Alcohol and Hepatitis C--The NIAAA is an active and integral
component of the research initiatives and collaborations among
the NIH Institutes regarding hepatitis C virus (HCV). Heavy
drinking increases the severity of hepatitis C and complicates
its treatment. Recognizing the substantial increased risk for
infected individuals to advance to end-stage liver disease and
liver failure, the NIAAA has released a Request for
Applications (RFA) in fiscal year 2000. This solicitation
specifically focuses on the role of alcohol in promoting end-
stage liver disease and subsequent death in HCV patients.
Principal goals of this research include elucidating alcohol's
impact on the course of hepatitis C, as well as exploring
potential mechanisms and their exploitation in the development
of successful treatment options.
In fiscal year 1999, the NIAAA also cosponsored other HCV
initiatives. For examples, the NIAAA participated in the
requests for Hepatitis C Research Centers, sponsored by the
National Institutes of Allergy and Infectious Diseases (NIAID),
that will provide a national research network blending basic
research and clinical investigations to promote translational
research in HCV research--that is, bring the basic research
findings into the clinic. In addition, the NIAAA co-sponsored a
request for Small Business Innovation Research (SBIR)
applications to establish new animal models to advance the
field of alcohol and hepatitis C research. An underlying
premise is that multi-disciplinary basic laboratory, animal
model and clinical research is needed to advance our
understanding of HCV and the liver disease and cancer it can
cause. The Institute also has established a new collaboration
with the American Liver foundation's (ALF's) ``Hepatitis C
Initiative'' and is working closely with the ALF in advancing
patient-related information and activities.
--Alcoholic Liver Disease--Scientists have made significant progress
in understanding the biological mechanisms that lead to organ
damage in alcoholic liver disease (ALD), the fourth leading
cause of death among urban U.S. males and a source of costly
morbidity. Among the findings are that reactive oxygen species
(namely, producers of free radicals, which cause harmful
changes in many molecules) and Tumor Necrosis Factor (TNF), a
protein that causes an inflammatory response, play major roles
in ALD, NIAAA-funded investigators are researching numerous
methods to either inhibit TNF expression in liver cells
directly through genetic manipulation or by specific insertion
of TNF-inhibitors into liver cells. In fiscal year 1999, the
Institute expanded this research area through a Program
Announcement (PA), entitled ``Mechanisms of Alcohol-Induced
Hepatic Fibrosis,'' which solicits grant applications
elucidating new therapeutic approaches for the fibrosis seen in
alcoholic liver diseases. Since TNF is implicated in many major
diseases (for example, cancer, arthritis, and multiple
sclerosis), advances in discovering how to selectively express
cytokines associated with organ damage will benefit a variety
of disciplines.
--Research and Practice Forums--In 1997, the Director of New York's
Office of Substance Abuse Services met with NIAAA Director Dr.
Enoch Gordis to discuss a number of issues affecting prevention
and treatment services in the State. Two ideas emerged: (1)
directing research dissemination efforts specifically to
clinical directors of treatment programs, and (2) developing a
rigorous research demonstration project to test recommended
science-based clinical practices and measure outcomes in four
or six volunteer treatment programs. To fund these efforts, the
Institute entered a partnership with the Center for Substance
Abuse Treatment (CSAT). The first phase of the collaboration
was a ``research-practice forum'' held in Saratoga Springs, NY,
in October 1998. The research symposium was designed
specifically for clinical supervisors and directors in New York
who received the most cutting-edge research findings on issues
affecting their work for incorporation into their programs. In
turn, researchers also benefitted from input and information
from the supervisors about real world barriers and difficulties
encountered in their clinics.
The NIAAA and CSAT continue work with New York State, the
provider's association, and clinical directors of six programs
on phase II of this project. Six programs have been selected to
participate in the Best Practices/Researcher in Residence
Program. The program's goal is to encourage the adoption in
clinical practice of recent treatment research advances by
placing nationally recognized scientists in brief periods of
residence at participating clinical treatment sites.
Information exchange between participating researchers and
clinical supervisors and staff will occur through training
sessions, research seminars, presentations of recently-
developed techniques, case reviews, and clinical problem
solving.
This program has been expanded to the State of North Carolina
where a forum was held in November 1999. Phase II of the North
Carolina project is under discussion and will be implemented in
year 2000. If efforts in these two states shod sufficient
promise, they will be repeated elsewhere throughout the
country.
INTERNATIONAL CONFERENCE ON RURAL AGING
With more than fifteen percent of the West Virginia's population
being at least sixty-five years of age, a percentage that is expected
to increase over the next several years, such statistics underscore the
need to take a closer look at how the needs of an aging population may
affect West Virginia, the United States, and nations around the world.
To help address the challenges associated with aging, delegates from
around the globe are slated to converge in Charleston, West Virginia,
this coming June for the international ``Rural Aging: A Global
Challenge'' conference. The rural aging conference is planned to direct
special attention toward meeting the needs of the elderly residing in
the some of the least developed areas of the world. Organizers hope
that the event will result in a stronger commitment to senior citizens
by both the public and private sectors.
Question. Currently, West Virginia University has submitted its
application to the Administration on Aging for release of the remaining
$500,000 that I secured for implementation of the conference. What
steps will you take to ensure the funds are released before the June 9,
2000 deadline?
Answer. The Administration on Aging has been in frequent contact
with the staff from West Virginia University to assure processing of
funds as quickly as possible. Extensive technical assistance has been
provided to assist in the planning of the conference. The Project
Officer at the Administration on Aging has helped University staff
connect with representatives of the U.S. Federal Committee, State
International Year of Older Persons coordinators and internationally
recognized speakers. She has also developed publicity, recommend
substantive program content and identified partners who are providing
help in handling the details of this event. Based on all the assistance
provided HHS has every confidence the funds will be released before
June 9.
With more than fifteen percent of the West Virginia's population
being at least sixty-five years of age, a percentage that is expected
to increase over the next several years, such statistics underscore the
need to take a closer look at how the needs of an aging population may
affect West Virginia, the United States, and nations around the world.
To help address the challenges associated with aging, delegates from
around the globe are slated to converge in Charleston, West Virginia,
this coming June for the international ``Rural Aging: A Global
Challenge'' conference. The rural aging conference is planned to direct
special attention toward meeting the needs of the elderly residing in
the some of the least developed areas of the world. Organizers hope
that the event will result in a stronger commitment to senior citizens
by both the public and private sectors.
OBESITY IN WEST VIRGINIA
Question. The West Virginia Department of Health and Human
Resources reported in May 1999 that 4.2-percent of West Virginia's
population falls into the category of being clinically obese. This
alarming statistic places West Virginia first in the nation in obesity,
with the percentage reportedly growing higher each year. Sadly, it is
the children who are falling prey to this epidemic, making them the
fastest growing portion of the obese population. What steps are you
taking to create heightened obesity awareness and prevention,
particularly with regard to West Virginia?
Answer. The Department sees obesity as a very serious public health
problem. In fiscal year 2000, CDC received approximately $4.5 million
in new funds for nutrition/obesity activities. With these funds, CDC
will provide support to up to eight states to initiate nutrition and
physical activity programs to prevent and control obesity and related
chronic diseases. In carrying out these programs, states will (a)
select one or more priority population in which to plan and initiate
activities; (b) develop appropriate internal and external partnerships
to carry out the plan; and develop, conduct, and evaluate nutrition and
physical activity intervention programs. West Virginia is encouraged to
apply for CDC funding.
Currently, CDC provides funding for State-based school health
programs in West Virginia to: (1) develop a state system of support for
coordinated school health programs ($225,000) and (2) expand
comprehensive school health education, with a focus on physical
activity, nutrition and tobacco use prevention ($212,000). West
Virginia has used these funds to:
--Assist in the development and implementation of child nutrition
polices. The West Virginia's Department of Education requires
food served in school cafeterias to meet the dietary guidelines
and prohibits the sale of high sugar and high fat foods during
the school day;
--Evaluate and develop revised physical education requirements. The
State Board of Education requires Physical Education
requirements in grades K-8, and a full unit of Physical
Education instruction as a high school graduation requirement;
--Develop physical fitness requirements. President's Physical Fitness
Test is required by law for all students in grades K-9 which
includes a new accreditation standard that requires schools to
have a 40 percent passage rate on the test or show improvement
in each of the previous 3 years;
--Develop standards in health education and physical education for
the State Board of Education;
West Virginia plans to hold a Nutrition Symposium in 2001 for
school health teams that will focus on obesity and being overweight;
and continued physical education summits to help physical education
teachers change their focus from sports to lifetime fitness activities.
MEDICARE REIMBURSEMENT OF AMBULANCE SERVICES
Question. Earlier this year, the Health Care Financing
Administration (HCFA) advised all carriers to suspend any Inherent
Reasonable (IR) pricing until the Government Accounting Office (GAO)
has finished their study of current IR authority as revised by the
Balanced Budget Act of 1997 (BBA). Although HCFA is scheduled to
implement a fee schedule reimbursement for ambulance services beginning
January 1, 200 1, counties such as Doddridge and Marion are in dire
need of a reassessment. What can you do to provide relief to West
Virginia's ambulance services?
Answer. Since our instructions to the carriers to suspend any
inherent reasonableness activities, the Congress enacted the Balance
Budget Refinement Act of 1999 (BBRA). Section 223 of BBRA prohibits use
of the inherent reasonableness authority by the Secretary or her
contractors until (1) the General Accounting Office (GAO) reports on
its inherent reasonableness study, and (2) HCFA publishes a final rule
that responds to the GAO report as well as to the comments received on
the January 1, 1998 Interim Final Inherent Reasonableness regulation.
Therefore, we currently have no mechanism to provide relief to
ambulance suppliers in your state at this time.
______
Questions Submitted by Senator Dianne Feinstein
HEAD START
Question. The President's goal is to enroll $1 million children in
Head Start by 2002. Providing children with access to programs that
improve cognitive and social development in their early years is
important. And yet, ``Head Start has only vague performance standards
and no curriculum to stimulate the growth of literacy and numeracy,''
say Henry Aaron and Robert Reschaeur in Setting National Priorities,
The 2000 Election and Beyond. What is HHS doing to move Head Start from
custodial child care to a program that stresses cognitive development
and learning?
Answer. Head Start is America's premiere early childhood education
program, and continues to lead the way in state-of-the-art approaches
to enhancing young children's development. Head Start's performance
standards are, in fact, quite comprehensive and clearly delineate what
programs must do in serving children and families. These standards
cover the areas of Education and Early Childhood Development, Child
Health, Child Mental Health, Child Nutrition, Family Partnerships,
Community Partnerships and Program Governance, among others. A copy of
these standards is attached. Furthermore, it should be noted that the
Performance Standard on Education and Early Childhood Development
clearly requires that all programs must, in collaboration with Head
Start parents, implement a curriculum and goes on to discuss what this
curriculum must include.
This Administration has invested heavily in improving not only the
cognitive learning aspects of this program, but in raising its
standards. We have paired investment in critical elements of quality
such as teacher compensation and training with a tough approach to
enforcement of high standards in every Head Start program. Annual
salaries for Head Start teachers have increased from $14,600 in 1992 to
$20,700 this year. Since 1995, more than 140 local grantees have been
replaced because they have been unable to rectify deficiencies in
program quality. We will continue these investments in fiscal year 2001
and will devote more than half of all new Head Start money to continued
improvements in the quality of the program.
In addition, Head Start has made a commitment to measuring child
outcomes, including cognitive outcomes as well as other key aspects of
children's development and parental involvement. Our research shows
that typical children leave Head Start with a wide range of specific
knowledge and skills that prepare them for kindergarten. These
practical, common sense achievements form the foundation for continued
progress in learning by Head Start children in kindergarten where they
show statistically significant growth in vocabulary, letter
recognition, writing and other pre-reading skills.
Question. Would HHS be opposed to changing the focus of the Head
Start program so that more attention is placed on the development of
cognitive skills?
Answer. Head Start provides top-quality early childhood education
along with comprehensive services, such as health, nutrition, and
family support services, to almost 900,000 low-income, preschool
children and their families across the nation, including more than
81,000 children and their families in California.
Head Start currently places a strong emphasis on cognitive skills.
Preliminary results from the Family and Child Experiences Survey
(FACES) indicate that average program quality is in the ``good'' to
``excellent'' range and no classroom scored below the ``minimal
quality'' range. Head Start children are ready for school, performing
above the levels expected for children from low-income families who
have not attended center-based programs. The survey also found that 66
percent of Head Start parents read to their child three or more times a
week and that 70-90 percent of parents teach their children letters,
numbers or songs.
We are building upon this progress with new initiatives, including
expanded training in family literacy services, new partnerships with
prekindergarten and child care programs, and the development of local
grantee systems to track and analyze child outcome data.
Question. What kind of coordination or communication does the
Department of Education have with HHS on this program?
Answer. The Head Start Bureau has extensive collaborative
relationships and initiatives with the Department of Education,
including the following:
--Recent joint sponsorship with Title I, Even Start, and HHS's Child
Care Bureau of a national leadership forum of State leaders and
managers of prekindergarten, Head Start, and child care
programs to explore new opportunities to use State and Federal
early childhood funding to reach more children with higher
quality services and to identify ways to eliminate barriers to
cross-program collaboration.
--Long-standing involvement with ED in joint efforts to serve
infants, toddlers, and young children with disabilities,
including participation in the Federal Interagency Coordinating
Council, and public-private partnerships such as the Conrad
Hilton Foundation/Head Start $15 million initiative to training
community teams of Early Head Start, ED early intervention
program providers, parents and other community agency leaders
to improve serving to infants and toddlers with disabilities.
--Collaborative efforts in research and accountability efforts,
including joint sponsorship and funding of major longitudinal
studies of early childhood development (including the National
Center for Education Statistic's Early Childhood Longitudinal
Survey, Kindergarten & Birth Cohorts) and emerging efforts in
Title I and Even Start to utilize the Head Start Performance
Measures outcome measures in Federal evaluations and State-
level accountability efforts.
--Additional leadership efforts between Head Start and public
education programs and systems occur at the State and local
level through the nationwide network of Head Start-State
Collaboration Offices which give priority attention to forging
linkages among local Head Start agencies, family literacy
initiatives, State prekindergarten programs, and local
education agencies.
--Finally, and most importantly, every local Head Start grantee is
held accountable for maintaining strong and effective
partnerships with local elementary schools and districts
through specific mandates covering the provision of family
literacy and adult education services, services to children
with disabilities, and preparing every child and family for a
successful transition to kindergarten.
Question. Shouldn't we move Head Start to the Department of
Education and convert it into a strong preschool program and focuses on
cognitive development?
Answer. I do not believe that Head Start should be transferred to
the Department of Education. While the cognitive elements of Head Start
are extremely important, the genius of the program is that it is
comprehensive. It integrates health, nutrition and family support
services with education and learning. The American Customer
Satisfaction survey found that Head Start=s composite satisfaction
score of 87 is unsurpassed among all public and private entities in the
survey. Head Start parents said that they would recommend Head Start to
other parents and that they are confident that Head Start will continue
to do a good job of providing preschool education in the future. In
addition to these high levels of parent satisfaction, Head Start
programs demonstrate exemplary levels of parent involvement, a key
ingredient in children=s success.
We are continuing to introduce new initiatives to challenge and
support Head Start's drive for excellence, including expanded training
in family literacy services (in collaboration with the Department of
Education's Even Start program), new partnerships with pre-kindergarten
and child care programs and funding sources, and the development of
local grantee systems to track and analyze child outcome data.
IMMUNIZATIONS
Question. You have told me that opening up the Federal Vaccines for
Children Program to SCHIP beneficiaries would require a legislative
change. Would you support legislation to make SCHIP beneficiaries
eligible for the Vaccines for Children Program? If no, why not?
Answer. The Department would not oppose such legislation.
HIV/AIDS
Question. What are your plans to reinvigorate the government's
focus on preventing the further spread of HIV/AIDS, particularly in
communities of color?
Answer. The Centers for Disease Control and Prevention has the lead
for the Department in preventing the further spread of HIV/AIDS. CDC
has initiated a number of national, regional, and community-based
programs designed specifically to reach racial and ethnic minorities at
greatest risk of HIV infection. CDC is focusing specifically designed
programs on the HIV/AIDS prevention needs of African- Americans and
other disproportionately affected racial/ethnic minority communities in
three broad categories: technical assistance and infrastructure
support, increasing access to prevention and care services, and
building stronger linkages to address the needs of specific
populations.
In October 1999, CDC awarded funds to more than 100 organizations
throughout the nation to expand HIV prevention efforts in African-
American and other communities of color at high risk of infection,
including Latinos, Native Americans and Asian Pacific Islanders
communities. The 1999 awards represented a 50 percent increase in
funding earmarked for HIV prevention efforts in African-American
communities. Awards include 47 African American community-based
organizations (CBOs) and 7 State and city health departments to develop
HIV prevention programs in correctional facilities to reach high-risk
minority populations, as well as, new national efforts to encourage HIV
testing among African- Americans and others at high risk of HIV
infection.
In addition, CDC continues to provide funds to State and local
health departments for HIV prevention. Funding priorities for the
health departments are determined through a community planning process.
Community planning provides an approach to ensure community voices and
programs to keep pace with the local epidemic, and States are strongly
encouraged to direct resources towards their HIV epidemic. Funds are
used to (1) address prevention needs in communities of color; (2) build
capacity of grassroots organizations to deliver effective, targeted,
culturally competent interventions; and (3) supplement funds for
demonstration projects focusing on HIV seropositive persons,
correctional activities, and perinatal prevention work. In fiscal year
2001, an increase of $40 million will fund grants allocated through the
community planning process to focus on high risk populations, including
minorities. An additional $10 million will also be directed towards
the"Know Your Status'' campaign in fiscal year 2001 to focus
predominantly on minority populations.
Question. What has HHS learned during the past year about the
effectiveness of the current role and structure of the CARE Act in
improving access to HIV treatments among underserved communities?
Answer. Over 67 percent of Ryan White CARE Act programs provide
services to minorities, based on 1997 Annual Administrative Reports
from CARE Act grantees. An initial draft of a study conducted by the
University of California, San Francisco, and supported by HRSA, did not
find minorities disproportionately under represented in acquiring
access to HIV treatments when other public funding and entitlement
benefits programs (e.g., state programs and Medicaid) are taken into
consideration. The study's final report is expected by the end of
fiscal year 2000.
Question. Do you think the current formula used to distribute
funding is effective and working? Why or why not? If not, what changes
would you propose to the formula?
Answer. We do believe the current formula for distributing funds
under Title I and II, which was revised when the CARE Act was
reauthorized in 1996, is effective and works. In order to more fully
understand and address the complex set of issues associated with the
allocation formulas, the Administration supports the authorization of
an Institute of Medicine study to examine the financing and delivery of
HIV services to low-income, under and uninsured persons with HIV.
Question. Do you think the current formula effectively sends funds
to areas where the AIDS epidemic is? Why or why not? If not, what
changes would you propose to make?
Answer. We believe the current formula effectively sends funds to
areas where the AIDS epidemic is. In order to more fully understand and
address the complex set of issues associated with the allocation
formulas, the Administration supports the authorization of an Institute
of Medicine study to examine the financing and delivery of HIV services
to low-income, under and uninsured persons with HIV.
Question. What can HHS do to make certain that the funding is going
to communities most impacted by the epidemic? What should Congress do?
Answer. As you already know, Congress appropriated additional funds
to address the needs of minority communities through the Congressional
Black Caucus initiative in both the fiscal year 1999 appropriation and
the fiscal year 2000 appropriation. The Agency allocated funds to
communities based on the allocation process specified in the report
language accompanying the fiscal year 1999 appropriation and is
assessing the impact of these funds. In allocating these funds,
grantees were provided direction in the use of these funds. The fiscal
year 2000 appropriation significantly increased the amount of CARE Act
funding designated for minority communities.
We understand that the Senate is beginning to discuss Ryan White
reauthorization. We believe that this reauthorization can strengthen
the Ryan White program's ability to ensure that funding is going to
communities most impacted by the epidemic. This can be accomplished by
considering changes to the Act that will focus on methods for
identifying and reaching HIV-positive individuals who are not currently
receiving care, increasing the service capacity of providers in
underserved communities, and establishing increasingly accountable
service networks.
BIDIS
Question. Given the widespread availability of bidis and their
harmful health effects, it is especially important that bibis be
included in all anti-tobacco programs. What is HHS, FDA, and CDC doing
to address the increasing use of bidis?
Answer. Research has shown that bidis are a significant health
hazard to users, leading to an increased risk of coronary heart disease
and cancers of the mouth, pharynx and larynx, lung, esophagus, stomach,
and liver. One study found that a bidi produces more than three times
the amount of carbon monoxide and nicotine and more than five times the
amount of tar than a cigarette, when tested on a standard smoking
machine.
In 1996, the Food and Drug Administration (FDA) published a final
rule prohibiting the sale of cigarettes and smokeless tobacco products
to minors. The Agency has been enforcing the provision since 1997 in an
enforcement partnership with state and local governments.
Bidis are not ordinarily sold in conventional tobacco retail
establishments. FDA is carrying-out research to determine the types of
retail outlets that are likely to sell bidis; results are expected
shortly. Once this information is available FDA can then determine
whether additional unannounced inspections should be conducted in those
establishments.
This is of course, contingent upon the Supreme Court's review of
FDA's legal authority to regulate tobacco and tobacco related products.
Recent trends related to bidi use among youth underscore the need
for a greater focus on preventing young people from ever starting to
use bidis or any other tobacco product and to help young people to quit
tobacco use. The Centers for Disease Control and Prevention (CDC)
continues to help States address the use of bidis and other tobacco
products through the implementation of comprehensive tobacco prevention
and control programs. In particular, CDC is working with States to
develop messages to inform the public about the health risks attributed
to bidis use to refute the notion that they are safer to smoke than
cigarettes, explore ways to involve young people and their families in
efforts to prevent tobacco use to include bidis, and survey teens in
order to determine trends in bidis use.
There is still much to be done, but we have established dialogue
and provide ongoing technical assistance to the states and national
organizations in their efforts to effectively address all tobacco
issues, including bidi use.
Question. Shouldn't all bidis packages carry health warning labels?
If so, what are you doing to make certain this happens?
Answer. The Federal Trade Commission (FTC) is working with bidis
manufacturers and the U.S. Customs Department to ensure that health
warning labels are properly placed and appear on bidi packages imported
into the U.S. Anecdotal evidence indicates that some bidi packages
imported and sold in the U.S. do not contain health warning labels. The
public is encouraged to notify the FTC if they observe bidi packages
not containing health warning labels. The FTC should answer further
questions regarding the placement of the Surgeon General's rotating
health warning labels on packs of bidis.
Question. Shouldn't they be sold with the same age restrictions as
other tobacco products? If so, what are you doing to make certain this
happens?
Answer. Bidis are subject to the same age restrictions as other
tobacco products. Bidis are not safe and should never be considered a
safe alternative to any form of tobacco product including cigarettes,
spit tobacco, cigars or pipes. Therefore, concerns regarding the
accessibility of bidis among youth are similar to minors' access issues
for other tobacco products. Currently, bidis are available through the
Internet, tobacco shops, some ethnic food and convenient stores, and in
selected health stores. Anecdotally, youth (under the age of 18) have
little difficulty purchasing them.
The Synar Amendment, enacted in 1992 and implemented by the
Substance Abuse and Mental Health Services Administration (SAMHSA),
requires States to enact and enforce laws prohibiting any manufacturer,
retailer, or distributor from selling or distributing tobacco
products--including bidis--to individuals under the age of 18. The goal
of the amendment was to reduce the number of successful illegal
purchases by minors to no more than 20 percent of attempted buys by
minors in each State within a negotiated time period.
SAMHSA is working closely with the States to broaden their
enforcement to include spit tobacco, cigars, bidis, etc. in addition to
cigarettes. In addition SAMHSA is conducting a series of State and
regional studies to measure the availability of these tobacco products
to youth, and whether there are differences in retailers' willingness
to sell to youth based on the type of tobacco product.
Question. How can we expand health services in underserved areas by
reducing training opportunities of qualified health professionals? Why
did you propose to cut funding?
Answer. The fiscal year 2001 budget will work to ensure a diverse
workforce that is adequately distributed. The request is $218 million,
an $84 million reduction. Within this overall funding level HRSA will
focus resources on programs which will help disadvantaged students and
reflects the Administration's goal to move away from broad-based
categorical programs. Within this level there is a $10 million increase
for the Centers of Excellence and the Health Careers Opportunity
programs, both of which have success in increasing diversity by
recruiting and retaining promising racial and ethnic minority students
in health professions training. Also included in the total request is
$80 million for the Children's Hospitals Graduate Medical Education
(GME), doubling the funding available in fiscal year 2000. These funds
will raise the level of GME support for approximately 60 freestanding
Children's Hospitals to be more consistent with other teaching
hospitals.
NIH SALARY CAP
Question. Wouldn't an increase in the NIH salary cap benefit
biomedical research?
Answer. An increase in the NIH salary cap is unlikely to benefit
biomedical research directly. In those instances in which an
institution chooses to provide a base salary that exceeds the current
statutory salary cap, an increase in the salary cap could affect the
amount of their own funds that research institutions have available for
the support of the government-university research enterprise. However,
covering the additional costs for those grants resulting from an
increase in the NIH salary cap could reduce the number of awards the
NIH is able to make.
Question. Do you support an increase in the salary cap to Executive
Level I?
Answer. In the fiscal year 2001 President's Budget, the
Administration proposes to maintain the salary cap at Executive Level
II.
STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) ENROLLMENT
Question. Why is enrollment in SCHIP so low?
Answer. In December 1999, HHS announced that enrollment in SCHIP
was nearly 2 million for fiscal year 1999. This represents a doubling
in enrollment since December 1998. We are pleased with States' success
in finding and enrolling these eligible children.
Remember, SCHIP is still a relatively new program and now that all
States have programs approved, we expect to see further increases in
enrollment once the programs are fully implemented.
States continue to engage in and improve upon outreach activities
that will increase the number of children enrolled in SCHIP.
Furthermore, States continue to submit plan amendments to expand the
eligibility levels for their programs.
Question. What are the Department's current efforts to improve
enrollment and decrease obstacles to enrollment in SCHIP?
Answer. The Administration's FamilyCare coverage proposal builds on
States' operating SCHIP programs by expanding SCHIP to parents. This
will increase enrollment of children in the program because States
would be required to cover children up to 200 percent of the Federal
Poverty Level before covering parents in fiscal year 2001-2005.
Furthermore, we believe enrollment of children in SCHIP and Medicaid
will increase because children are more likely to be enrolled in health
insurance if their parents are also enrolled.
FamilyCare also permits States to pool allotments with employer
contributions toward the purchase of private coverage. Thus, families
that would be eligible for FamilyCare will be able to access their
employers' health plan as long as the employer contributes half the
family premium costs and the health plan met FamilyCare standards.
In addition to covering the parents of SCHIP and Medicaid eligible
children, we expect to cover an additional 400,000 uninsured children
over the next 10 years through several new tools, including:
--allowing school lunch programs to share eligibility information
with Medicaid,
--expanding sites authorized to determine presumptive eligibility for
SCHIP and Medicaid,
--requiring States to make their Medicaid and SCHIP enrollment
processes equally simple.
Over the next 10 years, we expect to cover 4 million additional
people, that is, 3.5 million new adults (parents of Medicaid-eligible
children) and 500,000 new children in Medicaid and SCHIP.
Question. What are the current efforts to ensure retention in the
programs?
Answer. Since the welfare reform law was enacted in 1996, the
Department has issued guidance and other information to the States
about how Medicaid eligibility rules and procedures have been affected
by welfare reform. Perhaps the most significant was a detailed guide,
released in March 1999, that sets forth the Federal requirements and
proposes a range of options that can promote enrollment among eligible
families, including those leaving welfare. This guidance made it clear
that transitional Medicaid is available to all families that would
otherwise lose their Medicaid coverage due to earnings. HCFA is working
with States to ensure that eligible families continue to receive
Medicaid after they leave welfare without any gap in coverage.
Through its Regional Offices, HCFA recently conducted on-site
reviews in every State and territory to examine current policies and
practices with regard to Medicaid applications, eligibility and
enrollment in the post-welfare reform environment. One goal of this
effort is to take the appropriate steps to ensure that eligible
families receive and retain Medicaid, including ``transitional''
Medicaid.
In addition, we will be synthesizing the findings from the site
visits and developing a plan for the next steps, including technical
assistance, corrective action if appropriate, and best practices
identified through our site visits.
On January 6, 2000 we released guidance advising States of the
continued availability of Federal funds set aside in the 1996 welfare
law to help States cover the costs of adapting their Medicaid policies
and systems to welfare reform changes. At the end of last year, the
Administration worked successfully with Congress to extend the life of
this fund. Most States have a considerable amount of funds to use for
these purposes.
Finally, on April 7, 2000 we released guidance to ensure that
eligible low-income families are able to enroll and stay enrolled in
Medicaid. The letter to State Medicaid Directors covers State
responsibilities in three related areas: identifying and reinstating
people terminated improperly; processes for redeterminations for
eligibility; computerized eligibility systems.
REPORTS REQUESTED IN LAST YEAR'S APPROPRIATIONS LANGUAGE
Question. What is the status of these reports?
Answer. Reports will be submitted at a later date.
Question. When will we receive these reports?
Answer. Reports will be submitted at a later date.
INDIAN HEALTH SERVICE FUNDING
The budget calls for an increase of $192 million for the Indian
Health Service. While the increase in funding is appreciated, I fear it
will not be enough to bring Indian Health up to even minimal standards.
In 1998, the House Appropriations Subcommittee on Interior directed
the Indian Health Service to work with Tribes to address the question
of funding equity for Indians. That group used outside consultants with
proven experience in actuarial research and analysis. Using the Federal
Employee Benefit Package (FEBP) as a model, the group analyzed funding
for Indian Health in four defined Indian populations.
What the group found was that an additional $1.2 billion dollars
would have been needed in fiscal year 1999 to fully provide services
comparable to those in the FEBP. The average cost of providing the
FEBP-like services is $2980 per American Indian per year (of which
approximately $750 is available from non-IHS sources such as Medicaid,
CHIP and Medicare.) The IHS currently has on average only $1,200 of the
needed residual amount of $2,230 per person per year.
Question. Congress asked for this funding study, the results are
in. Why, then, did the Administration not ask for more funding for the
IHS?
Answer. The Administration has proposed an increase of $230 million
for the Indian Health Service as a step towards eliminating the
disparities in health outcomes which currently exist between Indian
people and other Americans. This 10 percent increase is the largest
requested for the Indian Health Service in over two decades.
Much of the disparity in health outcomes is closely linked to
poverty, unemployment, and lower levels of educational attainment in
much of Indian country. To address these problems, the Department's
budget includes a $96 million increase in other programs targeted
towards American Indians and Alaska Natives including increases in Head
Start, Child Care, tribal TANF, the Administration for Native Americans
and the Administration on Aging. The requested increase for the
Administration for Native Americans is also the largest in over two
decades. Looking at the Administration's entire budget for Native
Americans, a total of $9.4 billion is requested, an increase of $1.2
billion over fiscal year 2000.
Question. What can the Administration do to help me bridge this gap
between supply and demand?
Answer. The Administration has requested an increase of $1.2
billion in funds for Native Americans for a total of $9.4 billion.
HHS's part of this request includes an increase of $326 million in
funding targeted to American Indians and Alaska Natives for an HHS
total of $3.5 billion. Funding requests for both HHS Agencies which
exclusively serve Native Americans-the Indian Health Service and the
Administration for Native Americans-are the largest in over two
decades.
In addition to requesting increased funding, better inter-agency
cooperation is an important means of bridging this gap. The Health Care
Financing Administration has worked to increase Medicare and Medicaid
collections at Indian Health Services facilities by 103 percent since
1995. The Indian Health Service has recently entered into
collaborations with the Centers for Disease Control and Prevention, the
Head Start Bureau, the Substance Abuse and Mental Health Services
Administration, the National Institutes of Health, the Bureau of Indian
Affairs, the Agriculture Department, the Justice Department and the
Veterans Administration.
Tribal consultation is also important to ensure that we understand
the problems of Indian communities and to assist these communities in
accessing assistance from all parts of the Department. In May of 1999,
HHS held its first Department-wide tribal budget consultation meeting,
Leaders from 35 tribes and tribal organizations presented
recommendations covering the entire Department. Our second Department-
wide tribal budget consultation meeting is scheduled for this coming
April. The Deputy Secretary has also held a series of five regional
meetings with tribal leaders over the past year.
A fourth way to bridge this gap is through supporting tribal self-
determination efforts allowing tribes to provide their own health
services under contract with the Indian Health Service. A recent
National Indian Health Board survey of tribal leaders found that
contracting tribes were significantly more likely to than non-
contracting tribes to believe that their health services had improved
over the past three years. The share of IHS's budget going for tribally
operated programs increased from 28 percent in fiscal year 1993 to 44
percent in fiscal year 1999. To support continued growth in tribal
self-determination efforts, the Indian Health Service's budget includes
an increase of $40 million for contract support costs.
CLINICAL TRIALS DATABASE
In 1997, Congress passed the FDA bill and included the Snowe-
Feinstein bill requiring HHS to establish a database and a 1-800 number
for clinical trials so that patients and doctors can find out what
research trials are being conducted for serious and life-threatening
diseases. It has been almost 3 years. I received a press release last
night saying you announced the launch at 12:01 a.m. Thank you very
much.
Question. Is it operational? Can people now call an 800 number? Can
they access it via the Internet? Are all research trials on it?
Federal, private, others?
Answer. The ClinicalTrials.gov database is operational and
available on the Web. The strategy adopted by the NIH was first to
develop, test, and implement an Internet-accessible database of
clinical trials; NIH is now investigating how best to implement an 800
number. There are presently about 4,200 clinical trials in this first
phase of the database. These are primarily clinical trials sponsored by
the NIH. There are also several hundred privately sponsored trials in
the database, primarily related to AIDS and cancer. In the second phase
of ClinicalTrials.gov, we will enter many more clinical trials
sponsored by other Federal agencies and private and commercial trials.
Question. When will it be completed? How often will it be updated?
What took it so long?
Answer. The ClinicalTrials.gov database will continue to evolve
indefinitely as new trials are added. The database is updated nightly
as new data are received by the NLM from the sponsors of clinical
trials. The clinical trials database was mandated by the November 1997
FDA Modernization Act. After considering various options for
implementation, NIH tasked the National Library of Medicine in
September 1998 to create the database. During fiscal year 1999, the NLM
worked expeditiously to organize the 20-plus NIH institutes to
establish standard data elements for each clinical trial and to input
the data for the first 4,200 NIH-supported clinical trials into the
system. The database was released to the public on February 29, 2000.
CANCER REGISTRIES
Last September, the Sacramento Bee reported under a headline,
``Retreat on Cancer,'' that California's landmark cancer registry is
``slowing falling apart.'' We were the leader in efforts to track
cancer at one time, dating back to the 1940s. But it's budget has been
flat for a decade.
Question. Admittedly the State should put more resources into our
cancer registry, but your proposal for funding cancer registries is
flat for fiscal year 2001, at $24 million. The American Cancer Society
recommends an appropriation of $55 million. Why aren't you increasing
funding for cancer registries?
Answer. As you know, developing a budget involved hard choices
between deserving programs. The Department is working hard to improve
cancer registries nationwide. The National Institutes of Health and the
Centers for Disease Control and Prevention are working more closely
than ever to provide good epidemiological information on cancer. They
will pool their cancer data resources and create a national
infrastructure for cancer control and surveillance activities. CDC's
National Program of Cancer Registries (NPCR) and NIH's SEER together
cover virtually the entire U.S. cancer patient population. CDC supports
registries in 45 States, the District of Columbia, and three
territories. The SEER program covers 5 States, 5 major metropolitan
areas, rural areas in one State, and selected populations of American
Indians.
The California Cancer Registry has participated as an enhancement
state with the CDC's NPCR since 1994. On the basis of 1996 data, the
California registry has been certified by the North American
Association of Central Cancer Registries for its data completeness,
timeliness, and quality. An example of California's accomplishments
with its limited resources is that the state routinely reports cancer
rates for Asian and Pacific Islanders and for Hispanics. These rates
can then be compared with the more readily available rates for whites
and blacks. A recent registry report suggested that the state's tobacco
control program may have helped decrease incidence rates for lung
cancer among women in racial and ethnic minority populations.
The California registry is one of eight registries participating in
a special NPCR-supported childhood cancer project to design, implement,
and evaluate a method to use data from a state population-based central
registry to compute expected numbers of incident cancer cases in
children. The registry will evaluate completeness of its data and of
other existing pediatric cancer databases, such as the Pediatric
Oncology Group/Children's Cancer Group, by performing data linkage.
CANCER AND ENVIRONMENTAL RISK FACTORS
Question. NCI, NIEHS and CDC sponsor cancer research. Should we be
doing more on environmental risk factors for cancer?
Answer. The emergence of new research tools for clarifying how
environmental factors and susceptibility to cancer interrelate, has
opened many new possibilities for research on environmental risk
factors. The NCI has identified ``Genes and the Environment'' as a
major scientific opportunity for cancer research for fiscal year 2001.
Among the research areas for emphasis at both NCI and NIEHS are:
identify more fully the environmental causes of cancer using new
epidemiologic and genetic approaches; identify genes that modify
(increase or decrease) cancer risk, including the risk resulting from
environmental exposures; integrate information on genetic
susceptibility and environmental exposure to estimate cancer risks for
individuals, families, and populations; and develop new strategies for
cancer prevention, early detection, and treatment, building upon new
knowledge about the genetic and environmental determinants of risk.
The study of geographical variation in cancer rates has provided
important clues to the role of lifestyle and other environmental
factors that affect cancer risk. A new edition of the Atlas of Cancer
Mortality in the United States from 1950-1994 was recently published by
the National Cancer Institute. The geographic patterns of cancer
displayed in the atlas should help target further epidemiologic
investigations into the causes of cancer and to set priorities for
public health activities aimed at cancer prevention and control.
Epidemiology and Exposure Assessment
NCI and NIEHS have a long history of working together to explicate
the role of environmental factors in geographic variations in cancer
mortality patterns, especially for breast cancer. This working
relationship was established with the Congressionally mandated Long
Island Breast Cancer Study Project (LIBCSP) and the Northeast/Mid-
Atlantic Breast Cancer Program, both of which the Institutes have co-
funded. The latter program, comprised of highly productive research,
focusing on exposure to pesticides and related chemicals and
electromagnetic frequency radiation in relation to breast cancer risk,
has been completed and a report has been submitted to me.
Investigators on the Long Island Breast Cancer Study Project have
explored new ways to study the relationships between the environment
and breast cancer. However, much remains to be learned about the role
of environmental exposures and other risk factors and their interaction
with genes in promoting the development of breast cancer. Beginning in
mid-2000, a series of papers are expected to be published that will
address results of biomarker analyses, analysis of environmental
samples, and interview data on exposures both environmental and non-
environmental (e.g., diet, medications, medical irradiation,
electromagnetic field radiation).
In 1999, NCI, in collaboration with NIEHS, convened an ad hoc
advisory group of experts from many disciplines to discuss the present
status of environmental exposure assessments and cancer epidemiology.
Considerations for advancing the field during the next five years were
summarized, focusing on research needs and new research directions. NCI
and NIEHS program staff are currently preparing a request for
applications (RFA) on exposure assessment incorporating the discussions
at that meeting. It is expected that the RFA will be issued and funded
in fiscal year 2000.
An RFA issued by NCI and NIEHS, entitled ``Regional Variation in
Breast Cancer Rates in the United States,'' launched new projects in
which investigative teams are using statistical and epidemiologic
methods to investigate factors that may influence, contribute to, or
account for the reported differences in breast cancer incidence and
mortality rates across different geographic regions. Data on women
residing in California, Connecticut, Georgia, Hawaii, Iowa,
Massachusetts, Michigan, New Mexico, Washington, Wisconsin, and Utah
will be analyzed. A supplement to an ongoing study in New York is
evaluating the effect of electromagnetic field radiation (EMF) on
breast cancer risk. The results of these studies will be critically
assessed to help direct the future research agenda on the environment
and cancer.
The NCI and CDC have worked collaboratively in several areas,
including cancer surveillance. A recent Memorandum of Understanding
lays out areas for future growth and development of this collaboration.
NCI will support CDC's efforts to enhance state-specific use of cancer
surveillance systems for cancer control and to develop appropriate risk
communications tools for use with public inquiries about cancer rates
and trends.
The NCI's Epidemiology and Genetics Research Program (EGRP) was a
co-sponsor of four initiatives led by the National Institute of
Occupational Safety and Health (NIOSH) within CDC. The NCI component
supported the environmental and/or occupational exposure assessments
for epidemiologic studies of cancer.
In response to two of these initiatives, entitled ``Implementation
of the National Occupational Research Agenda'' and ``Mechanistic-Based
Cancer Risk Assessment Methods,'' four new grants were awarded to
develop and/or improve methods for assessing past environmental and
occupational exposures that could be associated with geographically
related cancers, including breast cancer. Research of this type (called
exposure assessment) is important in understanding breast cancer for
two reasons. First, we must be able to link breast cancer development
to a carcinogen exposure that occurred years before the diagnosis; and
second, we must be able to obtain environmental data for assessing the
role of gene-environment interactions in the etiology of breast cancer.
Intramural Geographic Information System Projects
A new area that offers some promising technologic methods for
assessing the impact of environment on cancer is the Geographic
Information Systems (GIS). NCI has completed several intramural
projects designed to develop methods to use GIS in estimating exposure
to crops sprayed with pesticides, drinking water contaminants, and
measures of proximity to industries that release toxic substances.
Methods to identify populations potentially exposed to agricultural
pesticides using remote sensing and a GIS were evaluated. Several
future efforts are planned to further examine the usefulness of GIS in
cancer-related studies. Researchers will evaluate the accuracy of
several ``address-matching algorithms'' that determine the geographic
location of respondents in health-related studies, and a comparison
will be made of household levels of pesticides in dust with proximity
measures to pesticide-treated crops, as estimated by GIS methods. A
``pesticide drift model'' will be incorporated into GIS estimates of
pesticide exposures among persons living adjacent to crop fields
sprayed with pesticides.
In studies of cancer etiology, GIS methods will be used to help
evaluate geographic patterns in prostate cancer mortality in relation
to nitrate levels in drinking water and pesticide use. A GIS will be
used to map populations in the Platte River Valley usingpublic and
private water supplies and to estimate nitrate exposure in drinking
water to evaluate associations with rates of several cancers. In a
study of bladder cancer, Global Positioning System measurements will be
collected and locational information will be used to link residences to
information on water quality in existing databases and to evaluate
proximity to industries and industrial releases of toxic substances.
Environmental Genome Project and Gene Expression Technology
The many rapid advances in technologies for molecular genetics
research are providing new opportunities to understand the genetic
basis for individual differences in susceptibility to environmental
exposure and how exposure and susceptibility interrelate to the
development of diseases like cancer. The NIEHS has established a
research program on genetic susceptibility to environmentally-
associated diseases through its Environmental Genome Project, which is
aimed at the identification of allelic variants (polymorphisms) of
environmental disease susceptibility genes in the U.S. population, the
development of a central database of polymorphisms for these genes, and
population-based studies of gene-environment interaction in disease
etiology. By identifying those genes and allelic variants that affect
individual response to environmental agents, scientists can better
predict health risks and assist regulatory agencies in the development
of policies on environmental protection policies. As previously
mentioned, NCI has identified ``Genes and the Environment'' as a major
scientific opportunity in cancer research for fiscal year 2001. We are
only beginning to amass these data, and much more work is needed.
cDNA microarrays are tools that can be used to analyze changes in
patterns of gene expression that contribute to cancer development. This
technology may revolutionize the way problems in environmental health
are investigated. Given that exposures to different classes of
toxicants result in distinct patterns of altered gene expression,
microarray technology can be utilized to categorize and classify these
effects through the direct comparison of gene expression patterns in
control samples versus those treated with toxicants. In defined model
systems, treatment with known toxic and carcinogenic agents, such as
polycyclic aromatic hydrocarbons, dioxin-like compounds, peroxisome
proliferators, oxidant stress, or estrogenic chemicals, may provide a
gene expression ``signature'' on a microarray which represents the
cellular response to these agents. These same systems can then be
treated with unknown, agents under suspicion, to determine if one or
more of these standard signatures is elicited. This approach will also
help elucidate an agent's mechanism of action and may also be used to
detect changes in exposed human populations, information essential for
the risk assessment process. cDNA microarrays also hold promise for the
determination of interactions between combinations of agents (e.g.,
dioxin and estrogen). It is also likely that new molecular targets of
toxic or carcinogenic action will be identified, and that these new
targets may be good candidates for analysis in the Environmental Genome
Project. NIEHS and NCI each have established the capacity to do cDNA
microarray technology. In a collaborative research project with the
National Human Genome Research Institute; NIEHS is developing custom
cDNA arrays or ``chips'' that comprise human cDNA clones oriented
toward the detection of the expression of genes involved in responses
to toxic insult. The initial ``ToxChip'' we have designed includes
genes for xenobiotic metabolizing enzymes, cell cycle components,
oncogenes, tumor suppressor genes, DNA repair genes, estrogen-
responsive genes, oxidative stress genes, and genes known to be
involved in apoptotic cell death. Plans call for this technology to be
available eventually to both intramural and extramural scientists on a
collaborative basis. NCI has been actively promoting and funding the
use of DNA microarray technology into the extramural community through
a variety of approaches. The NIEHS is also working to enhance capacity
for cDNA microarray technology in research institutions.
By exploiting recent advances in human genetics and recombinant DNA
technology, we can develop animal models and in vitro assay systems to
identify carcinogens and toxicants in a matter of weeks rather than
years, with considerable savings in terms of money and use of animals.
Using cDNA microarray technology, for example, toxicologists may be
able to expose cells or tissues to chemicals whose toxicity is unknown
and match the results against the ``signature,'' or common set of
changes in gene expression, produced by a known class of toxicants.
This would reduce the need for lengthy and expensive rodent bioassays
and could lend itself to testing the effects of low-dose as well as
long-term exposure. The use of cDNA microarray technology to assess
changes in gene expression in response to specific environmental
exposures is a rapidly growing research area that will have a large
impact on the environmental health sciences, including molecular
epidemiology, and drug discovery. It is appropriate that the
development and validation of this new application to environmental
health science is being led by the NIEHS since this technology could
revolutionize the field. Similarly the leadership of the NCI in
applying this new technology, in cancer research, will speed new
discoveries of environmental factors that contribute to cancer.
Also, it is now possible to modify genes in animals thus
orchestrating the carcinogenic process. For example, incorporation of a
chemically inducible oncogene into the germline produces animals with
multiple copies of the modified gene in all the cells of the organism.
Conversely, one can delete one copy of a gene that acts as a tumor
suppressor. Such so-called transgenic animals are much more responsive
to carcinogenic exposures. In preliminary studies, a carcinogen can be
identified in these animals in six months (rather than two years).
NIEHS has taken the lead to establish a major collaborative effort
involving the Environmental Protection Agency (EPA), the Food and Drug
Administration (FDA), the pharmaceutical and chemical manufacturing
industry, and two foreign governments (Japan and the Netherlands) to
validate the four transgenic mouse models currently available for their
capacity to predict carcinogenicity.
The NCI is planning to augment its Mouse Models of Human Cancer
Consortium to develop new experimental models that parallel human
cancer related genes, pathways and processes. The use of model systems,
particularly the mouse with its powerful genetics, will elucidate the
genetic basis of the etiology of cancer. The NIEHS is establishing
Comparative Mouse Genomic Centers which will focus on developing mouse
models for studying the biological function of variants of DNA repair
and control genes, found in the human population. Having identified
relevant genes in the mouse, we can then assess whether the comparable
human genes contribute to the cause of human cancer. Manipulating the
genetics of the mouse experimentally will enable us to decipher not
just the major genetic risk factors, but also those whose effects on
risk are more subtle. To find these same less penetrant genetic
effectors in human populations will require much more time and the
accumulation of very large populations. Transgenic mice also afford the
opportunity to test the contributions of nutrients and endogenous and
exogenous environmental factors in cancer etiology.
Question. Isn't it well established that cancer can develop from
the interaction of genes and the environment (broadly defined)?
Answer. The importance of lifestyle and other environmental
exposures as causes of cancer is unquestionable. The pivotal role of
environment is reflected in the substantial variation in cancer
incidence around the world and in the changes in risk observed among
groups that migrate and become acculturated in a new host country.
Furthermore, epidemiologic research has succeeded in identifying a wide
range of factors that affect cancer risk, including tobacco use,
dietary components, sunlight, ionizing radiation, environmental
chemicals, infectious agents, obesity, exercise, and hormones.
Nevertheless, the causes of many cancers remain elusive. While improved
approaches to measuring exposures will provide new insights, it is
clear that the environment represents only part of the equation in
determining who is susceptible to cancer. It is also important to
understand cancer susceptibility. For example, why does one person with
a cancer-causing exposure (such as smoking or infection with human
papillomavirus) develop cancer while another does not?
Viewing such questions through the lens of genetics promises to
provide insights into these apparent paradoxes. The scientific
investment in cancer genetics, initially focused on the intensive study
of rare cancer-prone families, already has paid huge dividends. These
studies have opened a unique window into the basic mechanisms of
cancer, with benefits extending well beyond the rare families from
which they were derived. This is because the genes identified by these
studies are altered forms of normal genes involved in key biochemical
pathways controlling fundamental cell processes. It has become clear
that these same pathways contribute to the development and progression
of the more common, non-hereditary forms of cancer. Despite evidence
that one's genetic makeup may influence susceptibility or even
resistance to cancer-causing exposures, only recently have the tools
become available to systematically determine how variations in these
genes combine with environmental and other factors to induce cancer in
the general population.
Question. What is the right balance?
Answer. It is difficult to answer since NIH is striving to
understand the causes of cancer through a comprehensive evaluation of
genetic and environmental determinants as well as their interactions.
In particular, by incorporating recent major advances in molecular
genetics into epidemiologic studies, it will be possible to gain not
only insight into genetic susceptibility but also a more complete
understanding of the specific lifestyle and other environmental
exposures that are mediated through genetic pathways and affect the
risk of developing cancer.
______
Questions Submitted by Senator Ben Nighthorse Campbell
HEALTH STATUS OF AMERICAN INDIANS
Question. It is my understanding that you have made statements
regarding your support of efforts to improve the health status of
American Indians and Alaskan Natives and that one of your most recent
public statements was made last July to a number of tribal leaders here
in Washington. Could you clarify what role you see the Department of
Health and Human Services, outside of the Indian Health Service, taking
in these efforts?
Answer. A major goal of both the Department and the Administration
is the elimination of racial disparities in health outcomes.
Accomplishing this goal will require substantial improvements in health
outcomes for Native Americans who suffer a greater disease burden than
other Americans. The Indian Health Service has primary responsibility
for improving Native American health outcomes but many other parts of
HHS also have a role to play. For example, the Health Care Financing
Administration has worked to increase Medicare and Medicaid collections
at Indian Health Services facilities by 103 percent since 1995. The
Centers for Disease Control and Prevention, the Substance Abuse and
Mental Health Services Administration, and the National Institutes of
Health all collaborate with the Indian Health Services, assist Indian
communities directly, and or conduct research into diseases and health
conditions affecting Native Americans. While it is not a health Agency,
the Administration on Children and Families supports empowerment and
economic development of Indian communities through programs such as
Head Start, Child Care, Social and Economic Development Strategy
grants, and support for Tribes running their own TANF and Child Support
Enforcement programs.
To ensure that all parts of the Department play their part, we
hosted our first annual Department-wide tribal budget consultation
meeting last May. This annual meeting is called for in our policy on
Consultation with American Indian/Alaska Native Tribes and Indian
Organizations. Our second annual meeting is scheduled for next April.
Question. I have heard that it was a Department view that Indian
health issues were the responsibility of the Indian Health Service. Can
you tell me how you expect a direct health service organization to
research the causes of disease among Indian people or to test new
prevention efforts for Indian people when, by all accounts, it cannot
even fund the services necessary to treat existing health problems that
occur in American Indian and Alaskan Native people?
Answer. The Indian Health Service has primary responsibility for
improving the health status of American Indians and Alaska Natives but
many other parts of HHS also have a role to play. The Indian Health
Service has demonstrated its ability to make significant improvements
in Indian health, for example reducing maternal and infant mortality by
more than two thirds since the early 1970s. In order to continue these
improvements, we have requested a ten percent increase for the Indian
Health Service, the largest requested increase for this Agency in over
two decades. The total amount request for all Health and Human Service
programs targeted to American Indians and Alaska Natives is $3.05
billion, an increase of eleven percent over fiscal year 2000. The
request for the Administration for Native Americans is also the largest
increase requested for that Agency in over two decades.
The Grants for Special Diabetes Program for Indians offers a good
example of the work done by other HHS Agencies to assist the Indian
Health Service. The Centers for Disease Control and Prevention works
with this program to ascertain the epidemiology of diabetes, provide
technical assistance to tribal Diabetes Program grantees and helps to
establish partnerships between grantees and State Diabetes Control
Programs. Much of our information about type two diabetes and its
impact of on Indian communities comes from ongoing cooperative studies
between the Pima tribe and the National Institutes of Health. The
National Institutes of Health and the Indian Health Services are
cosponsors of a national multi-center study to determine if type two
diabetes can be prevented in those at high risk for the disease.
Volunteers from four Indian communities are participating in this
study.
Question. Aren't there agencies located within the Department of
Health and Human Services which specifically research the causes of
disease and test prevention efforts that would be better able to handle
those activities?
Answer. The Indian Health Service was created to carry-out the
Federal Government's commitment to deliver health services to Federally
recognized American Indians and Alaska Natives. It has demonstrated its
ability to make significant improvements in Indian health, for example
reducing maternal and infant mortality by more than two thirds since
the early 1970s. Other HHS Agencies address the health care needs of
all Americans but they do so by focusing on differing areas: research
at the National Institutes of Health, mental health and substance abuse
at the Substance Abuse and Mental Health Services Administration,
disease control and prevention at the Centers for Disease Control and
Prevention. Each of these agencies addresses the health care needs of
Indian people as part of its overall mission and each assists the
Indian Health Service in its delivery of health services to Federally
recognized American Indians and Alaska Natives. For example research at
the National Institutes of Health has provided much of our information
about type two diabetes and its impact of on Indian communities. The
National Institutes of Health and the Indian Health Services are
cosponsors of a national multi-center study to determine if type two
diabetes can be prevented in those at high risk for the disease.
Volunteers from four Indian communities are participating in this
study. In addition to its work on diabetes, the National Institutes of
Health supports the study of other disease in Indian populations such
as asthma and lung cancer. The Centers for Disease Control and
Prevention has established the National Diabetes Prevention Center to
address the epidemic of diabetes in Indian country, works with tribes
and tribal organizations to reduce breast and cervical cancer mortality
and is conducting studies to better control several Indian health
problems including Hantavirus, Hepatitis A and Pneumococcal infections.
The Substance Abuse and Mental Health Services Administration provides
funds to tribes and tribal organizations to plan and evaluate systems
of mental health care, prevent substance abuse, work with high risk
youth, and provide substance abuse treatment services.
HANTAVIRUS
Question. I recently picked up the Washington Post and read a story
alleging that the Centers for Disease Control and Prevention had
diverted millions of dollars of funds slated for hantavirus research to
other work. I know that several of my colleagues are concerned about
the way CDC officials handled the original hantavirus outbreak, and now
we hear that the same agency has been diverting millions of dollars of
money it has claimed was used on hantavirus research, contrary to
Congressional reports. Have you been able to determine exactly how much
was diverted form the hantavirus research program?
Answer. CDC made a mistake by not informing Congress of the need to
use some of the hantavirus funding for other deadly infectious
diseases, including ebola, lassa fever and Nipah virus. We have
commissioned an external firm, PriceWaterhouseCoopers, to conduct an
audit to determine specifically how the hantavirus funds were spent in
fiscal year 1999. In the fiscal year 2001 Congressional Justification,
CDC has proposed changes related to the hantavirus line to more
accurately reflect that these resources will be used for hantavirus and
other special pathogens.
In order to prevent such a situation from reoccurring, we have
established the following corrective action plan:
--The Department's Chief Financial Officer (CFO) will review and
certify, along with CDC's Financial Management Office (FMO),
the correctness of all of the National Center for Infectious
Diseases' (NCID) financial obligations through the remainder of
fiscal year 2000.
--The Department's CFO will ensure that all senior decision-makers in
the NCID will receive certified budget execution and financial
management training.
--CDC has initiated an external review of their fiscal management
practices, similar to the review done at NIH, to be completed
in six months. The results of this analysis will be
communicated to Congress as soon as the review is complete.
--CDC program managers will conduct a top to bottom review of CDC's
133 programs and projects to make sure there are no other areas
of concern. During a 90-day period, CDC managers will be able
to fully and openly identify any area for which there may be a
discrepancy between actual expenditures and the information
provided to Congress. This information will be reported to
Congress.
--CDC has commissioned Price Waterhouse Coopers, a firm of
independent auditors, to thoroughly examine its hantavirus
expenditures. The results will be communicated to Congress
immediately upon completion.
--CDC has appointed a new Acting Director for the Division of Viral
and Rickettsial Diseases while CDC seeks new leadership for
its' viral disease programs.
INDIAN HEALTH RESEARCH
Question. The President's request unveiled an initiative to improve
the lot of the ``First Americans''. Yet at least one proposed program
in the Centers for Disease Control and Prevention which would
specifically fund research benefitting American Indians/Alaskan
Natives, originally proposed as $40 million program, was first slashed
by 75 percent, then zeroed out as the budget process played out. Can
you explain why this program was such a low priority considering this
ambitious ``initiative?''
Answer. Our fiscal year 2001 request includes significant budget
increases, six percent for the Centers for Disease Control and
Prevention and ten percent for the Indian Health Service. While a
separate grant program for Tribes was not included in CDC, funding is
requested for similar activities in both the Centers for Disease
Control and Prevention and the Indian Health Service.
Our request for the Centers for Disease Control and Prevention
includes $35 million for Racial and Ethnic Approaches to Community
Health to support community demonstrations to eliminate health
disparities. Of the 32 grantees who received funding to plan these
demonstration, one was an Indian Tribe and two others focused on health
disparities of American Indians and Alaska Natives. Our $35 million
request also includes an increase of $1.5 million to fund eight to ten
Core Capacity Grants for American Indian and Alaska Native
organizations. The Centers for Disease Control and Prevention is also
working with tribes and tribal organizations to address diseases such
as diabetes and breast and cervical cancer.
Our request for the Indian Health Service, the largest requested
increase in over two decades, includes $230 million in total additional
funding to increase access to health care and reduce the gap in health
disparities. Included in this total increase is $11.5 million for
Preventive Health activities, including Public Health Nursing, Health
Education, and tribal Community Health Representatives; $41 million to
increase purchase of health care from the private sector, $40 million
to provided contract support costs for tribes operating their own
health programs, and $3 million for grants to improve the basic public
health infrastructure of tribes enabling them to conduct effective
community based injury prevention programs. Grants would be provided to
approximately 25 tribes.
INDIAN HEALTH SERVICE BUDGET
Question. Did you consult with Tribes or Tribal representatives in
the development of the Department of Health and Human Services budget,
outside of the Indian Health Service? Did you consult with Tribes or
Tribal representatives regarding the budget of the NIH or the CDC? Who
did you consult with and what was the extent of your consultation?
Answer. In August of 1997, HHS issued its first Department-wide
policy on consultation with American Indian and Alaska Native tribes
and Indian organizations. Under this policy, each Operating Division-
including the Indian Health Service-develops its own tribal
consultation plan. Budget matters are generally considered to be
critical for consultation.
In May of 1999, HHS held its first Department-wide tribal budget
consultation meeting prior to developing its fiscal year 2001 budget
submission. Leaders from 35 tribes and tribal organizations met with
members of the HHS Budget Review Board making recommendations covering
the entire Department. This coming April, we will hold our second
Department-wide tribal budget consultation meeting to consider the
fiscal year 2002 budget submission. As part of our consultation
process, the Deputy Secretary has held a series of five regional
meetings with tribal leaders over the past year.
INDIAN HEALTH RESEARCH
Question. I see in your budget justification that there are a
number of specific research initiatives for racial and ethnic groups,
but I did not see any that were directed only toward a single American
Indian or Alaskan Natives health issue. For example, there is a cancer
research effort at the University of Hawaii which focuses on the high
cancer incidence among Native Hawaiians, and a study of the excessive
prevalence of high blood pressure among African Americans. Yet I did
not come across a single initiative that targets a disease that
uniquely affects American Indians. Can you explain?
Answer. In general, the Department does not request funds for
initiatives targeting diseases which affect particular racial and
ethnic groups. One exception, of course is the $230 million increase we
have requested for the Indian Health Service to improve the health of
Federally recognized American Indians and Alaska Natives. While funding
in our other health agencies is not specifically requested for diseases
uniquely affecting American Indians, these agencies do carry-out
specific activities which improve the health of Native Americans. For
example research at the National Institutes of Health has provided much
of our information about type two diabetes and its impact on Indian
communities. In addition to its work on diabetes, the National
Institutes of Health supports the study of other disease in Indian
populations such as asthma and lung cancer. In fiscal year 2000, NIH
estimates it will spend a total of $98 million on research into
diseases and health conditions affecting American Indians and Alaska
Natives. The Centers for Disease Control and Prevention is also
addressing a number of diseases as they affect Indian people including
diabetes, breast and cervical cancer, Hantavirus, Hepatitis A and
Pneumococcal infections. In fiscal year 1999, CDC spent about $21
million for American Indians and Alaska Natives. The Substance Abuse
and Mental Health Services Administration provides funds to tribes and
tribal organizations to plan and evaluate systems of mental health
care, prevent substance abuse, work with high risk youth, and provide
substance abuse treatment services. In fiscal year 2000, the Substance
Abuse and Mental Health Services Administrations estimates it will
provide a total of $64 million for American Indians and Alaska Natives.
______
Questions Submitted by Senator Pete V. Domenici
NATIONAL INSTITUTES OF HEALTH/DEPARTMENT OF ENERGY PARTNERSHIP
Secretary Shalala, as you are aware the fiscal year 2000 Labor-HHS
Appropriations Bill contained a provision urging the Director of NIH to
establish a pilot program to ensure the National Institutes of Health
may benefit from technologies developed within the Department of Energy
weapons programs in terms of their potential to enhance health sciences
and improve medical care. The Pilot seeks to ensure that technologies
developed within the nuclear weapons program, as well as other
programs, of the Department of Energy are carefully evaluated for their
impact on the health sciences, with the goal of achieving clinical
applications and improved national health care.
Question. What is the status of the NIH/DOE Medical Technology
Partnerships?
Answer. NIH is evaluating the adequacy of current interagency
collaborations and the applicability of DOE laboratory technical
resources and capabilities to improving human health and quality of
life. In the area of biomedical engineering, the NIH research
institutes and centers have been made aware of DOE laboratory
capabilities and biomedical research programs to through the
Bioengineering Consortium (BECON) of which DOE has been a member since
1997. A meeting was held on January 18, 2000, between the staff of the
NIH Office of Extramural Research and representatives of the DOE's
Office of Science to discuss specific areas of interagency cooperation
in bioengineering research and training. Possible joint research
funding initiatives were identified and are being pursued. Potential
interagency training and personnel sharing opportunities were
discussed, as were ways for DOE staff to become more familiar with and
involved in NIH research programs. With regard to the weapons
laboratories, a meeting of NIH Office of Extramural Research staff, NIH
research institute staff, key DOE weapons laboratory technical
representatives, and DOE Headquarters personnel was held on February
24, 2000, to identify areas of potential collaboration and ways to
facilitate more effective interaction.
At the upcoming April 19, 2000, BECON meeting, DOE's Office of
Science will make a presentation to NIH staff to provide further
information on DOE's laboratory biomedical technology capabilities
within its bioengineering program. NIH staff will also be attending and
participating in the DOE Bioengineering Contractor's Meeting scheduled
for May 16-18, 2000, in Albuquerque, New Mexico. Based on the results
of these meetings and current NIH/DOE collaborative efforts, an
evaluation will be made of the need for a formal interagency
partnership and appropriate follow-up actions initiated.
Question. What other steps are being taken by NIH to ensure that
technologies being developed by other Federal agencies are identified
for possible medical/research applications?
Answer. Since 1997, the NIH's Bioengineering Consortium (BECON) has
provided a link with other Federal agencies in areas associated with
applications of engineering/physical science technologies and
principles to biomedicine. To ensure that technologies developed by
other Federal agencies are identified for possible medical
applications, BECON actively facilitates interagency communication,
sponsors bioengineering symposia, and coordinates NIH participation in
interagency bioengineering initiatives. To directly communicate
biomedical research progress and directions to NIH staff, other Federal
agencies (e.g., DARPA, NSF, and DOE) are invited to provide
presentations during the regular monthly BECON meetings which are open
to the public. BECON also coordinates NIH participation in interagency
biomedical initiatives such as the Interagency Working Group on
Nanotechnology (IWGN), the Multi-Agency Tissue Engineering Science
(MATES) Working Group, and the Bioengineering Materials and
Applications (BEMA) Roundtable. Information on these types of
activities is shared with BECON members during regular monthly
meetings. To afford engineering and physical science researchers at all
Federal agencies opportunities to make the biomedical community aware
of technologies that could have possible biomedical applications, BECON
sponsors major annual bioengineering symposia that are open to all
interested participants. Finally, the BECON has developed and maintains
a Web site aimed at providing information on all aspects of biomedical
engineering (including technology development) to the general public,
scientific community, and Consortium members.
DIABETES
Question. Diabetes contributes to approximately 200,000 deaths each
year and is the leading cause of blindness, kidney failure and lower-
limb amputations. The disease costs the nation $105 billion annually in
direct and indirect costs. Today CDC operates only 16 comprehensive
diabetes programs. Does CDC have any plan to expand this program in a
phased fashion to all 50 States? What will in take in your professional
judgment to reach all 50 States?
Answer. The overall financial constraints in the fiscal year 2001
budget forced many hard choices in public health and other programs.
One of those hard choices was whether to increase the number of
comprehensive diabetes programs, or fund other pressing needs. CDC
currently provides funding for diabetes programs in 50 States; 16
comprehensive programs with average funding of $800,000 each, and 34
capacity-building programs. CDC also carries out a wide range of
surveillance, applied research, and public education activities that
are essential in making its partnership with the States effective. The
$51 million requested in the budget will enable CDC to continue making
significant progress in reducing the burden of diabetes. CDC has
estimated that, absent competing needs in CDC and other agencies, its
diabetes program could make good use of up to about twice that amount.
NIH BUDGET
Question. In recent years, NIH has recommended to Congress
allocations that generally spread the funding increase evenly among
institutes. This method of funding causes smaller institutes that also
have viable research opportunities to lack the necessary monies to fund
important research. Do you think that across-the-board percentage
allocations every year adequately fund all new scientific
opportunities? How about funding new scientific opportunities in those
institutes who receive lessor funding? How do automatic across-the-
board percentage allocations really reflect new discoveries?
Answer. This is a time of great productivity in the biological
sciences. Many fields of medical research deserve increased financial
support and could move faster with more funds. However, historical
factors and the level of research funds already committed to grant
recipients leave a relatively small fraction of each year's
appropriation that can effect changes in funding policies. Since
resources are not infinite, providing considerable funds to a
particular area of emphasis limits what is available to others.
Allocations to the Institutes and Centers do vary to reflect many
factors and consultations. Decisions that affect resource allocation or
priorities at the NIH, including distribution of funds among the ICs;
how much to devote to a certain discipline, disease, or grant
mechanism; or which applicants to fund are influenced by several
factors:
--An obligation to respond to public health needs, as judged by the
incidence, severity, and cost of specific disorders. However,
calculations of public health needs are difficult, and the
results cannot be correlated with research spending in a simple
manner.
--A commitment to support work of the highest scientific caliber. A
basic tenet of our stewardship is the pledge to maximize the
return on the public's investment in research; to do this, we
demand that all requests for support pass stringent peer review
in regard to scientific quality.
--A responsibility to seize the scientific opportunities that offer
the best prospects to develop new knowledge and lead to better
health. As administrators of science, we have learned that the
most significant and rapid advances are likely to occur when
new findings, often serendipitous, lead to expansion of other
research opportunities.
--A need to maintain a diverse portfolio that supports work in many
scientific disciplines and on a wide range of diseases. Because
we cannot know when major discoveries will occur and what
opportunities they will create, it is important to support
ongoing research across a broad frontier.
--An obligation to insure a strong scientific infrastructure, with a
high quality workforce and excellent research facilities.
Productive science cannot be done without well-trained
investigators and modern equipment and laboratories.
NIH BUDGET
Question. Dr. Varmus was very fond of saying ``research in one area
would lead to discoveries in other areas.'' How, then, are these
promising areas being applied to those diseases that receive less
funding?
Answer. Research probes and seeks to understand the unknown. The
scientific insights that provide a basis for solutions usually
accumulate over many years, and often are derived from the efforts of
investigators from diverse disciplines with expertise in specific areas
of science working on and communicating about differing facets of a
problem. Medical discovery is marked by stops and starts, and a vital
interplay among theories or questions (hypotheses), experimental
evidence, and clinical observations. It is very hard--if not
impossible--to predict the next discovery or to anticipate what
advancement in prevention, treatment or diagnosis of one disease will
be applicable to new knowledge about another, seemingly unrelated,
disease.
NIH's medical research program is a diverse and continually
evolving portfolio that reflects the agency's obligation to respond to
public health needs, commitment to supporting research of the highest
scientific caliber, and judgment as to the scientific opportunities
that offer the best prospects for gaining new knowledge and better
health. Sometimes scientists, when exploring the fundamental mysteries
of the cell, know at the outset of their research that its findings
will be applicable to understanding many diseases. For example,
scientists hard at work determining the structure and electrochemical
properties of a specialized pore, called the potassium channel, that
helps regulate heart rhythm know that this information will be used in
physiologic investigations of potassium channels, which are critical
for many bodily functions, besides regulating the heartbeat, such as
nerve signaling, digestion, and insulin release. A better understanding
of potassium channels may help scientists develop drugs to treat
diseases ranging form heart ailments to diabetes to epilepsy.
However, despite our best efforts to ascribe or assign research to
a particular disease or condition, the serendipitous nature of science
makes it hard to predict, with any real certainty, just which diseases
will benefit from a particular line of investigation. Although
different disease processes vary in their nature and complexity, they
often have some commonalities. The progress made in understanding one
disease often yields new ways of thinking about the etiology of
another, seemingly unrelated, disease. Thus, new knowledge gained from
one line of research may help re-frame or re-focus the entire approach
being used to solve the most perplexing problems associated with
understanding a totally different disease. For example, cancer is a
disease which has its origin in the function, or malfunction, of the
most fundamental process, cell division, and the enzymes that affect
the process. New knowledge about the function of enzymes in cancer
cells can have and indeed, has had a profound effect on scientists'
understanding of other diseases that may also have their origins in
similar enzyme malfunctions, such as inherited metabolic diseases.
Similarly, new information about how some osteoporosis drugs for
osteoporosis preserve the integrity of bones, have suggested that these
same drugs might be useful in reducing the spread or metastasis of
prostate and colon cancers to bone.
A surprising example of this kind of cross-fertilization started in
the area of cardiovascular disease. Years of research focused on the
formation of new blood vessels as a means of improving circulation in
patients with atherosclerosis (hardening of the arteries). Researchers
now have taken this knowledge and applied it to a totally different
goal--if we knew how to promote the formation of new blood vessels,
could we block their formation? And would this not impede the growth of
tumor cells, which, like all living cells need a blood supply to
survive and grow. This effect, then set cardiovascular researchers to
look at the role of blood vessel formation. They found that such
formation promoted the development of plaques that blocked the flow of
blood. This intersection of scientific discoveries has now set
researchers on a course to identify ways to block this effect and to
develop new therapies for improving circulatory diseases. These stories
are not unique in the annals of innovation and scientific discovery.
In addition to basic research yielding discoveries that can be
applied in many different areas, discoveries from research in one
specific disease area often prove to be related to other diseases. For
example, AIDS research is unraveling the mysteries surrounding many
other infectious, malignant, neurologic, autoimmune, and metabolic
diseases. AIDS research has provided an entirely new way to design
drugs and to treat viral infections. The development of the new ``flu''
drug, RelenzaTm (zanamivir), which directly benefitted from AIDS
research. Another drug developed to treat AIDS is now the most
effective therapy for chronic hepatitis B infection. Drugs developed to
prevent and treat AIDS-associated opportunistic infections also provide
benefit to patients undergoing cancer chemotherapy or receiving therapy
to prevent rejection of transplants. AIDS research also is providing
new understanding of the relationship between viruses and cancer.
One line of investigation often yields several potential and
unpredicted new uses, which can be applied to the treatment or
prevention of more than one disease. Thus, because scientific findings
cross disease lines, so does the distinction or attribution of research
investment and discovery cross Institute and Center lines.
Question. Don't automatic across-the-board increases for every
institute each year actually pit one disease against another? By
allowing large institutes to grow at the same rate as small institutes,
aren't you actually ignoring many potential scientific opportunities in
the smaller ones? Doesn't this prevent NIH from following their own
stated research funding criteria meant to identify areas of greatest
need and greatest potential?
Answer. Decisions that affect resource allocation or priorities at
the NIH, including the distribution of funds among the ICs; how much to
devote to a certain discipline, disease, or grant mechanism; or which
applicants to fund are influenced by the numerous factors outlined
above. Advice is solicited from and provided by a large number of
individuals and groups, including the members of the scientific
community, Advisory Councils, patient advocacy groups, Congress, the
Administration, and NIH staff. Each Institute and Center (IC) convenes
meetings of its national advisory council or board, composed of members
from the public, medical, and scientific communities, to review a broad
range of policies. Scientific opportunities arise with the advent of
new technology and new discoveries in various diseases. As these
discoveries are made, areas of greatest need and greatest potential are
prioritized based on scientific opportunity and the financial resources
that can be allotted to the study of these diseases so as to ensure
that outstanding science is being funded and that such studies are
aimed at obtaining results.
Question. Given that CDC has called diabetes ``the epidemic of our
time,'' do you think NIH devotes adequate funds to research this
serious disease? If so, why? If not what can be done to increase the
diabetes research portfolio at NIH?
Answer. The President's fiscal year 2001 Budget Request for
diabetes research across the NIH is $561 million. The NIH are
implementing many of the new and expanded initiatives in response to
the scientific recommendations of the DRWG. However, there are
scientific opportunities in diabetes-and indeed in most areas of
research--that the NIH will not be able to pursue as rapidly or as
fully as it might wish, given the NIH budgetary framework and our
responsibility to support an overall national biomedical research
agenda that addresses the many diseases afflicting Americans.
______
Question Submitted by Senator Kay Bailey Hutchison
Question. Madam Secretary, recently, there was an editorial in the
Houston Chronicle by Nobel Prize winner Dr. Norman Borlaug, known as
``the Father of the Green Revolution'' on the benefits of agricultural
biotechnology. A growing number of scientists and agriculture producers
in Texas and throughout the world are realizing the tremendous
potential of biotechnology in agriculture to feed a growing population
with better environmental outcomes. In Texas, for example, over 60
percent of cotton grown in the Texas Panhandle is already enhanced by
modern biotechnology. What measures are you and your Department taking
to support, foster, and encourage this promising new technology?
Answer. As you know, FDA has authority over the safety of nearly
all domestic and imported foods and food products in interstate
commerce, including bioengineered foods. One of the most important
roles of this Agency in supporting this technology is to ensure that
the bioengineered foods that enter the marketplace are as safe as the
traditionally developed products in our grocery stores, and that such
foods undergo appropriate safety testing prior to marketing. We are
confident that the bioengineered foods that have reached the U.S.
market to date meet the standards of safety that apply to other food
products.
In the fall of 1999, FDA announced an initiative to engage the
public about foods made using bioengineering, and held a series of
public meetings in November and December. One of the purposes of those
meetings was to inform participants about FDA's policy and processes
for ensuring the safety of bioengineered foods. FDA personnel shared
the Agency's experience over the past five years in reviewing safety
and nutritional assessments conducted on foods from more than 40
bioengineered plant varieties. FDA also solicited information from
participants and the public regarding whether FDA's policy or
procedures should be modified and also solicited comments on
appropriate means of providing information to the public about
bioengineered products in the food supply.
During those public meetings, we did not hear any evidence of food
safety concerns about the products that have been marketed thus far,
although some participants expressed concerns about potential safety
issues with products that may be included in the next generation of
bioengineered foods. Other participants suggested ways in which FDA
could better inform the public about its processes and procedures. FDA
is currently reviewing comments received in response to the public
meetings and the agency's call for information. When we have completed
that review, the agency will be in a position to develop and implement
strategies for its biotechnology program and to articulate its plans
for next steps.
______
Questions Submitted by Senator Herb Kohl
Question. Why does the Administration fail to require background
checks for all long-term care workers?
Answer. The Administration has proposed a system of abuse registry
and criminal background checks for nursing home workers. Our provider
agreements make these facilities clearly identifiable, our statutory
and regulatory authority and annual surveys provide the means for
monitoring and enforcing the proposed new requirements, and existing
State nurse aide registries can provide information for the proposed
national abuse registry. Our proposed system would include developing
the national abuse registry, adding FBI background checks, and creating
a new capacity in each State to screen and report FBI data to nursing
homes. Even with start up funding and user fees, it would take some
time for these systems to develop the ability to promptly respond to
background checks from the nation's 17,000 nursing homes. For these
reasons, it seems prudent to begin efforts on criminal background
checks for long term care workers with nursing home staff.
HCFA also has regulatory and survey authority for home health
agencies, hospices, and ICFs/MR. Once we have developed the systems and
experience to handle background checks for nursing home employees, we
would be in a better position to assess whether and how to expand such
checks to these other three long term care settings that we do not
regulate or survey. It would be problematic and to effectively enforce
employee background check requirements in these other settings.
Question. As it appears in the HHS budget, it seems that the
Administration's background check proposal will be funded by user fees
within both HHS and DoJ. Unfortunately, there are few details about how
these two agencies would coordinate their systems so that facilities
can have one-stop shopping. Could you please elaborate on how you
envision this system working? Do you have estimates on how much this
would cost nursing homes annually?
Answer. For purposes of developing the President's budget, HCFA
assumed that the background checks would be a two step process. First,
a nursing home would request a query of the national abuse registry. If
a report comes back that the prospective employee has a history of
abuse, neglect, or misappropriation of resident property, the process
would end there with the individual disqualified from employment with
the nursing home. We estimate that nursing homes would pay HHS about $4
per query for a total of about $4.3 million for this portion of the
background check in the first year of implementation.
If the abuse registry check produces no disqualifying information,
the nursing home would proceed to the second step, a criminal
background check request. The nursing home would obtain finger prints
and other information from the prospective employee and forward them to
a designated agency in their State. From that point, the designated
State agency would serve as the ``one-stop shop,'' collecting an
additional fee from the nursing home for the remainder of background
checks. The designated State agency would forward the finger prints and
other information to appropriate law enforcement authorities in the
State and in the FBI to conduct State and national criminal background
checks. The designated State agency also would receive the State and
FBI data it receives to identify any disqualifying information, report
the results back to the nursing home, and handle disputes by
prospective employees of the accuracy and relevance of disqualifying
information. We estimate that the second, criminal background check
phase of the process would cost nursing homes about $70 per check or
about $41.1 million in the first year, with the designated State agency
forwarding the appropriate portions of the fee to the FBI and State law
enforcement agency.
The first step in the development of this system will be to
determine the most effective and cost efficient methods for
implementing a national abuse registry. HCFA plans to conduct such a
study to include an assessment of current processes used by States and
providers. We will be examining ways to create a ``one-step shop''
where all information could be accessed. The information from the study
will feed into the ultimate implementation of the proposal.
Question. As you know, I have worked hard for the past several
years to boost funding for nursing home inspections under the Survey
and Certification program. I realized that the Administration continues
to work hard on the Nursing Home Initiative to improve the quality and
safety of nursing home residents. This year, you've asked for $234
million for Survey and Certification, but you've again assumed $63
million that would come from user fees, which Congress has declined to
enact in the past. Assuming that trend continues, will the
Administration still support the full $234 million and find money in
the budget to pay for it?
Answer. The Administration strongly supports the need for the full
$234.1 million amount for the State Survey and Certification program.
User fees have been proposed the past three years as a means of
reducing pressure due to Government-wide discretionary funding
limitations. If enacted as proposed, the user fee would reduce HCFA's
$234.1 million appropriation request by $63 million, to a total of
$171.1 million in fiscal year 2001. Should Congress decide to not enact
the user fee proposal, the Administration request the entire $234.1
million in appropriated funds to support State Survey & Certification
activities.
Question. Would the Clinton Administration support, and more
importantly, actively advocate for legislation to restore the SSBG's
funding and transfer levels?
Answer. Under section 8401 of the Social Security Act, the
authorization for the Social Services Block Grant was reduced to
$1,700,000,000 for fiscal year 2001 and each year thereafter. In
addition, under that same section, the limitation on the amount
transferable to Title XX was reduced to 4.25 percent in the case of
fiscal year 2001 and each succeeding fiscal year.
The President's Budget for fiscal year 2001 for the Social Services
Block Grant includes a proposal to increase the amount provided to the
Block from $1,700,000,000 to $1,775,000,000. It also is expected that
states will use state funds to help offset any impact that this change
might cause.
______
DEPARTMENT OF EDUCATION
Questions Submitted by Senator Arlen Specter
CLASS SIZE REDUCTION
Question. Mr. Secretary, it is my understanding that the class size
reduction funds are to be distributed to the neediest schools with the
highest numbers of poor children. If the very purpose of the program is
to help schools that are struggling to resolve overcrowding in poor
districts, how do you expect these schools to meet the matching funds
requirement?
Answer. The Department does not believe that requiring local
districts to provide a 35 percent match on any new Class Size Reduction
funds they receive would be burdensome for most districts, and those
districts that would have the greatest difficulty in providing such a
match would be exempt from the requirement. In addition, a district
would match only the amount above what it received in fiscal year 1999.
At the 2001 request level, for an average district, the amount of the
match would be only about $15,700.
We need to help poor schools and districts overcome the challenges
they face in preparing their students to meet high standards. Research
has demonstrated the benefits of reducing class size in the early
elementary grades, particularly for lower-achieving, minority, low-
income, and inner-city students. Class Size Reduction funds enable
districts to reduce class size, particularly in the early elementary
grades, so that teachers can provide students with more individualized
attention, spend more time on instruction, cover more material
effectively, and provide students and parents with more detailed
feedback on each child's progress. The Department believes districts
welcome Federal support to help them reduce class size in the early
grades.
Question. Further, how is the exemption for low-income school
districts realistic when 80 percent of the formula grant relies on
poverty data?
Answer. All schools districts, not just districts that serve large
numbers or percentages of low-income students, are eligible to receive
Class Size Reduction funds. We are proposing to exempt only those
districts in which at least 50 percent of the students they serve are
from low-income households. We estimate that, after exempting the
highest-poverty districts, the average national match provided by local
districts would equal 30 percent of the Federal appropriation.
FLEXIBILITY IN CLASS SIZE REDUCTION PROGRAM
Question. Given the diversity of needs that different school
districts have throughout the country--whether it is costs related to
special education, books, or computer technology investments--what is
the disadvantage of using class size funds to address the most pressing
demands identified by local school districts?
Answer. I believe that the strong, demonstrated benefits of reduced
class size in the early elementary grades justify making such an effort
a national priority. Students who receive instruction in small classes
make more rapid educational progress than their counterparts in larger
classes. This is particularly true for lower-achieving, minority, poor,
and inner-city children.
Under the appropriations language and our proposal for authorizing
the Class Size Reduction program as Title VI of the Elementary and
Secondary Education Act of 1965, districts that have met the target
level in grades 1 through 3 may use their funds to further reduce class
size in those grades, to reduce class size in additional grades, or to
improve teacher quality. Also, States that can demonstrate conditions
in certain districts that would make achieving the goal of 18 students
per classroom in the targeted grades a hardship, such as a lack of
facilities or a shortage of qualified teachers, can apply to the
Department for a waiver from some of the program provisions.
SCHOOL CONSTRUCTION
Question. According to the 1999 School Planning and Management
Construction Report, public school districts completed more than $15
billion worth of construction in fiscal year 1998, an increase of
almost $3 billion over the fiscal year 1997 level. The latest figures
indicate that almost $18 billion worth of construction was completed in
fiscal year 1999 and districts are starting $23 billion in fiscal year
2000, resulting in roughly $70 billion of construction completed/
planned in the last 4 years. To support its $26.1 billion proposal, the
Administration cites a GAO study that estimated $112 billion was needed
to bring schools into good condition.
Mr. Secretary, given the tremendous progress being made and the
fact that you have stated that the Federal Government is a junior
partner in the area of education, please justify the Administration's
proposal to assume a significant Federal role within a State and local
responsibility?
Answer. School construction is, and will remain, primarily a State
and local responsibility under the Administration's school construction
proposal. The vast majority of school facility needs will continue to
be met with non-Federal resources, and decisions about school
construction plans will continue to rest with State and local
governments. However, some States and communities are not, on their
own, able to meet the burden of providing adequate school facilities
for all students, and the poorest communities have had the greatest
difficulty meeting this need. The Administration's proposal would
provide financial assistance to school districts with substantial
construction needs and a limited ability to meet those needs.
We owe it to our children to improve the condition of schools in
order to improve their academic achievement and promote their physical
health. Students have difficulty learning when they attend schools that
are overcrowded, poorly lighted, either too hot or too cold, or unable
to accommodate modern technology. In addition, students can be exposed
to health hazards when they attend schools that are poorly ventilated
or contain hazardous substances, such as lead paint and asbestos.
While expenditures for school construction have increased over
recent years as the economy has improved, we believe that the need
persists for approximately $112 billion to bring schools into adequate
condition. Substantial school construction expenditures are necessary
just to keep from slipping further behind as school facilities continue
to depreciate and student enrollments swell. In addition, the increase
in school construction funding has not likely been targeted to those
communities with the greatest need for school construction funds.
FEDERAL SHARE OF SPECIAL EDUCATION COSTS
Question. Over the last 4 fiscal years, the annual increase
requested by the Administration for the State grants program, under the
Individuals with Disabilities Education Act (IDEA), has averaged about
5 percent per year. For fiscal year 2001, the request is once again for
about a 5 percent increase. Over the same period, Congress has
increased funding by over 20 percent per year. Federal funds are used
to help pay for the excess cost of providing special education and
related services for children with disabilities ages 3 through 21. The
Administration claims that the Federal contribution toward meeting the
excess cost of special education is currently 13 percent of the
national average per pupil expenditure.
Given the financial burdens that the requirements of the
Individuals with Disabilities Education Act (IDEA) place on States and
school districts, why are you so reluctant to substantially increase
spending for this program?
Answer. No State is required to participate in IDEA. However, the
rights and protections embedded in IDEA are fundamental civil rights
that guarantee children with disabilities access to equal educational
opportunity.
IDEA authorizes a maximum Federal contribution toward meeting the
excess cost of special education of 40 percent of the national average
per pupil expenditure. We believe that the legislative history
surrounding the enactment of Public Law 94-142 in 1975, which served as
the basis for the current IDEA, indicates that members of Congress
regarded the 40 percent as a goal, not a promise or commitment, and
members acknowledged that the authorized amounts were not likely to be
appropriated.
I support that goal. However, I also believe that the requested
level of funding for Special Education Grants to States provides an
appropriate level of support given the fact that States have the
primary responsibility for educating all children, including children
with disabilities. Our budget for the Department is designed to address
a broad range of needs and a number of national priorities. We believe
that our budget request for the Department reflects the best
combination of programs and funding to address the needs of all
children within our limited resources.
Question. How do you respond to school officials and parents who
say that the Federal Government is not meeting its financial obligation
with respect to special education?
Answer. There is a tendency to view the IDEA Grants to States
program as the Federal program for providing assistance to States in
serving children with disabilities. In fact, there are many Federal
programs that assist States in serving these children, but they are not
focused solely on children with disabilities. These programs include
programs such as 21st Century Community Learning Centers, which provide
a safe environment and expanded learning opportunities for children
before and after school; and the Class Size Reduction program, which
helps school districts improve education in the early elementary grades
by providing funds to hire highly qualified teachers and reduce class
size. Federal subsidies for school construction bonds that will be used
to repair, renovate, and construct schools will help ensure that our
school buildings enhance the teaching and learning of all children,
including children with disabilities.
The $290 million increase requested for Special Education Grants to
States would maintain the Federal contribution toward meeting the
excess cost of special education at 13 percent of the national average
per pupil expenditure by providing more than sufficient funds to offset
the impact of inflation and the additional cost expected to result from
serving more children.
TEACHER RECRUITMENT AND PROFESSIONAL DEVELOPMENT PROGRAMS
Question. Mr. Secretary, the President's 2001 budget request
includes $1.4 billion for teacher recruitment and professional
development programs, double the amount provided in fiscal year 2000,
excluding the amount provided for the Class Size Reduction Initiative.
Most of these programs are scattered throughout the Department and are
unauthorized. Furthermore, a 1999 GAO report found that over $1.5
billion in Federal funds is invested in professional development
programs, which span 13 agencies through 87 different programs. The
report also stated that over 86 percent of the Department of
Education's funding was used for professional development purposes.
Mr. Secretary, shouldn't the bulk of education dollars be delivered
to the student, especially those in the greatest need?
Answer. The Administration believes that investing in high-quality
professional development and teacher recruitment is one of the best
ways to ensure that all students, including those most at risk of
school failure, get the help they need to raise their academic
performance. That is why the Administration's 2001 budget request would
increase funds for teacher recruitment and professional development
programs, including $1 billion for the Title II programs that are
included in the Administration's proposal to reauthorize the Elementary
and Secondary Education Act (ESEA). We believe that these programs, in
total, will help States and school districts ensure that all students
are taught by fully qualified teachers who have the training they need
to teach to challenging State and local content standards.
Research indicates that high-quality professional development,
especially when it is focused on academic content, can contribute to
improvements in teachers' skills and practice and thereby raise student
achievement. The most recent evaluation report of the Eisenhower
Professional Development State Grants program (1999) indicates that
teachers believe professional development contributes the most to
improving their knowledge and skills if it: (1) is sustained over an
extended period of time; (2) is connected to State and district
standards and assessments; (3) emphasizes academic content and the way
students learn that content; (4) encourages teachers from the same
grade levels, departments, and schools to work in teams; and (5) offers
opportunities to observe and practice the teaching techniques being
introduced. The Teaching to High Standards State Grants program, the
Administration's proposal to reauthorize Title II of the ESEA, would
encourage school districts to implement professional development with
these characteristics, so that all students can be better prepared to
meet the challenges of the 21st century. In addition, provisions in our
Teaching to High Standards proposal ensure that funds are targeted to
those students who are most in need.
The 1999 General Accounting Office (GAO) report, Teacher Training:
Over $1.5 Billion Federal Funds Invested in Many Programs, found that,
in various Federal agencies in fiscal year 1999, over $579 million was
provided by programs that focus exclusively on teacher training and
that about $933 million was provided by programs that are designed to
achieve purposes other than just teacher training but support a
significant amount of teacher training.
department of education teacher training programs as a percentage of
all federal teacher training
Finally, I want to clarify findings in the GAO report. The report
did not find that over 86 percent of the Department of Education's
funding was used for professional development purposes. Rather, the
report states that teacher training programs administered by the
Department of Education accounted for over 86 percent of the $1.5
billion provided for teacher training programs across the Federal
Government in fiscal year 1999.
PROFESSIONAL DEVELOPMENT PROGRAMS AND EARLY INTERVENTION ADDRESS THE
ACHIEVEMENT GAP
Question. How do these programs address one of the most important
components of narrowing the achievement gap, which is early
intervention?
Answer. Early Childhood Educator Professional Development Grants, a
new program proposed as part of the Administration's ESEA
reauthorization bill, would create high-quality professional
development opportunities to improve the knowledge and skills of early
childhood educators and caregivers who work in communities with high
concentrations of young children living in poverty. The program would
promote school readiness and better learning outcomes for those
children by focusing on professional development designed to further
their language and literacy skills before they enter school.
The National Research Council report, Preventing Reading
Difficulties in Young Children (1998), concluded that the majority of
reading problems faced by today's adolescents and adults could have
been avoided or resolved in the early years of childhood. Reading
problems more often occur in children from poor families with little
education, and, as more of those children enter group care settings,
ongoing high-quality professional development for their preschool
teachers and caregivers is a key strategy in helping cultivate
children's literacy and language skills as a foundation for reading.
The Cost, Quality and Child Outcomes report (June 1999), partially
funded by the Department, concludes that children's cognitive and
social competence in the second grade can be predicted by the
experiences they had 4 years previously in child care, even after
taking into account kindergarten and first-grade classroom experiences.
The report also found that children who have traditionally been at risk
for not doing well in school are more affected by the quality of
childcare experiences than are other children. Many early childhood
providers have little formal education beyond high school, and
preschool and other group care settings for young children, in
particular those available to families with limited economic resources,
often provide relatively impoverished language and literacy
environments.
The Department would concentrate on funding projects that provide
professional development opportunities for early childhood educators
and caregivers working in high-poverty communities, including staff
working in Title I preschools, Head Start, Even Start, and public day
care programs.
IMPLEMENTATION OF TEACHER RECRUITMENT AND PROFESSIONAL DEVELOPMENT
PROGRAMS
Question. Please explain how the Department of Education plans to,
first, inform States and local educational agencies of all of these
programs; and second, ensure that both the Federal and State
governments implement them efficiently and effectively.
Answer. The Administration would provide information about these
programs to States, school districts, and other eligible recipients
through the channels that the Department has found to be most
successful in disseminating information about our programs. For
example, the Department would publish Federal Register notices about
the availability of funds, provide information about the programs at
conferences, such as the Department's annual Improving America's
Schools Conference, place information about the programs on the
Department's web site and in print materials, sponsor outreach meetings
to alert eligible applicants about opportunities to apply for funds,
and carry out other networking strategies the Department typically uses
to alert the public about new programs.
Strong accountability provisions in the Administration's
reauthorization proposal for the Elementary and Secondary Education Act
(SEA) will help ensure that these programs are implemented efficiently
and effectively, while allowing States and school districts the
flexibility that they need to address local needs. For example,
accountability provisions include requirements that grantees develop
and report on their success against performance indicators as part of
annual performance reports, and States would provide annual data about
the number of teachers who are fully certified or licensed and who are
teaching in their main teaching field.
EDUCATION FOR INCARCERATED YOUTH
Question. Mr. Secretary, there are over 2 million incarcerated
adults in the United States, the highest incarceration rate in the
world; and, according to the Department of Justice's most recent study,
there were 106,000 juvenile offenders residing in correctional
facilities in 1997. The National Adult Literacy Study indicates that
the majority of prison inmates either are illiterate or have marginal
reading, writing, and math skills. Most of these adults will return to
free society in 4 years, having received little to no education, which
has proven to be the key to preventing recidivism.
In light of these facts, can you justify the President's request
for a $2 million reduction in the State grants to incarcerated youth
offenders program, and the elimination of the Literacy Programs for
Prisoners?
Answer. The President's request for 2001 would continue support for
the Youth Offenders program at the fiscal year 1999 appropriation level
of $12 million, which is also the amount the Administration requested
in fiscal year 2000. The request, which is $2 million less than the
amount provided in the fiscal year 2000 appropriations act, will
provide States with a level that is consistent with the Department's
general policy of targeting funding increases to other priority
initiatives. At the requested level, States would have enough funds to
serve approximately 6,700 youth offenders. Through the program, States
expect to improve academic and vocational achievement, increase
participation in job placement programs, lower recidivism rates, and
increase job retention among youth offenders.
The Department requested no funds for Literacy Programs for
Prisoners in 2001 because this program's authorization ended with the
enactment of the Adult Education and Family Literacy Act of 1998
(AEFLA). States may use up to 10 percent of their AEFLA local grant
funds for programs for corrections education and services to
institutionalized individuals.
12-MONTH WORKING YEAR FOR TEACHERS
Question. Mr. Secretary, in your recent address to the Nation on
the state of American education, you proposed that teachers work a full
year to improve teacher quality and raise their pay. Can you tell me
specifically what steps the Department will take to establish this
policy?
Answer. The annual State of American Education address gives me the
opportunity to take a broad view of our education system and talk about
both what is working and where we might make some improvements. With
the success of the standards movement, one area we are really focused
on now is improving teacher quality. Our proposal to reauthorize the
Elementary and Secondary Education Act and our fiscal year 2001 budget
request contain a variety of measures to strengthen teaching in our
schools.
My call for elevating teaching to a year-round profession was not a
proposal for a new Federal policy, but a suggestion that we need to
look at the teaching profession in a new way. We need to attract highly
qualified individuals to the profession, in part through better pay,
and provide a working environment that lets them use all their talent
and skill to teach to the new high standards. I believe one way to do
this is through longer contracts that would give teachers more time to
plan the curriculum and improve their teaching skills.
States and school districts, of course, are responsible for setting
standards for teacher quality and determining the length of teacher
contracts. I am not proposing any Federal intrusion into this area.
What I said in my address is that I believe now is the time to begin a
national discussion about making teaching a better-paid, year-round
profession, and that governors and school boards should give serious
consideration to this idea.
Question. Given the Federal role in education, how will these steps
affect decisions that are made on the State and local levels?
Answer. We are not taking any specific actions to promote making
teaching a year-round profession, merely putting an idea out for
discussion at the State and local levels.
Question. Is this approach part of the Administration's
reauthorization proposal for the Elementary and Secondary Education
Act, which the Senate intends to consider in the next couple of weeks?
Answer. No. As mentioned above, we are not proposing any specific
actions to promote the idea, but simply putting it out for discussion.
YOUTH VIOLENCE PREVENTION
Question. Mr. Secretary, please provide your observations of the
relationship between movies, video games, and other related forms of
youth entertainment and youth violence?
Answer. Each day, children are exposed to numerous examples of
violence in the media--either through television, video games, music,
or the Internet. A 1999 study conducted by the Kaiser Family Foundation
found that on a typical day, children spend five hours and 29 minutes
using the media. Children ages 8 to 18 spent almost seven hours; 2- to
7-year-olds spent nearly three hours and 34 minutes. The media have
been successful in perpetuating, and even glamorizing, various images
of violence aimed toward children. Norms supporting and justifying
violence are seen daily in music videos, movies, and television. Yet,
despite the far-reaching influence of the media and popular culture on
children, there is little consensus regarding the impact that the media
have on youth violence. Several studies have related violence in the
media to actual violence by children, while other studies have
discounted the role and influence of the media on children, since the
media are only one of several sources of violent messages in our
society.
However, what we do know is that more and more children are being
exposed to violence in the media on a daily basis and that much of this
exposure is unsupervised by parents. And while we cannot point to a
direct relationship between violence in the media and violence in
children, we can assume that the images portrayed in music and on the
screen may contribute to, or reinforce, violent behavior and a lack of
empathy for victims.
While it may not be possible to eliminate violence in the media, as
parents and educators we can teach children how to be wise consumers of
the media and the messages portrayed. Media literacy training can be
useful, especially for students in the younger grades. In addition it
is important for parents to monitor their children's exposure to the
media. Parents need to know what types of movies, videos, television,
and websites they are viewing, and what types of music lyrics they are
hearing.
I have asked, and continue to ask, the leaders in the entertainment
industry and our expanding Internet industry to step back and think
about their responsibilities. Do we really need these violent video
games to excite our children in order to gain a profit? Is that extra
violent scene in a movie really needed to make a point? Does every
action hero need to wear a long black coat and carry a sawed-off
shotgun? The prime audience for movies in America today is the
impressionable teenager, and the key word is impressionable. I urge
Hollywood to help us raise our children right by ending their fixation
with violence. We need their vision and creativity to help in the fight
for our children's future. So my message to the entertainment industry
is clear and simple--stop glamorizing the assassin and the killer and
the use of guns. Stop listening to scriptwriters and start listening to
parents. Stop listening to advertisers and start listening to teachers.
______
Questions Submitted by Senator Kay Bailey Hutchison
VOLUNTARY SINGLE-SEX SCHOOL AND CLASSROOM PROGRAMS
Question. Mr. Secretary, as you may know, I have proposed
specifically authorizing the use of Federal education funds for public,
single-sex school and classroom programs, as long as the existing
Department requirement is met that students of both sexes receive
comparable educational opportunities. My amendment has passed
overwhelmingly in the Senate, by a vote of 69 to 29. Do you believe
that public schools should be able to use Federal funds for voluntary
single-sex education programs, and if so, will you support my effort to
include this amendment in reauthorization of the Elementary and
Secondary Education Act?
Answer. The Department of Education is examining whether there is a
legal basis for interpreting Title IX of the Education Amendments of
1972 (20 U.S.C. 1681 et. seq.) to permit single sex classrooms and
schools where they are justified on educational grounds and do not
involve stereotyping or stigmatizing students based on gender, and
where equivalent educational opportunities are afforded to students of
both sexes. These issues are sensitive and complex, including
consideration of the constitutional implications of any change, but we
have made substantial progress in our review and hope to issue proposed
regulations this spring.
With regard to your specific question, we are very committed to
exploring the permissibility of single sex schools and classes in
public schools, but believe that this issue should be addressed under
Title IX, and the answers should apply whether Federal, State, or local
funds are used for that purpose. Developing a separate civil rights
standard for single sex schools or classrooms under ESEA would create
confusion and would be inconsistent with the Civil Rights Restoration
Act. I hope that when we release our proposed regulation we will
receive your comments. In the meantime, however, I cannot support your
amendment because it defines the permissibility of single sex education
only within the context of ESEA.
CIVILIAN-BASED ``TROOPS-TO-TEACHERS'' PROGRAM
Question. Mr. Secretary, while I understand your desire to hire
additional teachers and reduce class size, I have an alternative or
perhaps complementary proposal that I would like your reaction to and
consideration of. I have introduced legislation to expand the very
successful Troops to Teachers program and apply it to the civilian
world, under the direction of your agency. Would you agree to consider
this proposal, and wouldn't you agree that this may be a tremendous
opportunity to place highly qualified, successful individuals in our
classrooms?
Answer. I support expansion of the highly successful Troops to
Teachers program as one strategy for helping to ensure that our
Nation's classrooms have highly qualified teachers who can help all
students achieve to challenging academic standards. In addition to the
Administration's request of $1.75 billion for the Class Size Reduction
program, the Administration has also requested $1 billion for a variety
of programs to improve teacher quality, including teacher recruitment
and retention.
Transition to Teaching program
One of these programs is the Transition to Teaching program, which
would continue the highly successful Troops to Teachers program and
provide additional funds to recruit, prepare, and support a wide range
of talented career-changing professionals--such as engineers and
scientists, corporate professionals, and returning Peace Corps
volunteers--as teachers, particularly in high-poverty school districts
and high-need subject areas. Former members of the military services
would continue to be a key focus of the new program's recruitment
efforts.
The Transition to Teaching program is included in the
Administration's proposal to revise and reauthorize the Elementary and
Secondary Education Act of 1965. Under the Administration's legislative
proposal, the Secretary, before awarding any grants or contracts, would
consult with the Secretaries of Defense and Transportation to determine
how much funding is needed to continue the Troops to Teachers program.
Once the Secretaries agree on an amount, the Secretary would transfer
these funds to the Department of Defense.
Recruiting teachers for high-poverty areas
With the remaining funds, the Secretary would award grants or
contracts to institutions of higher education, public agencies, and
nonprofit organizations to recruit, prepare, place, and support mid-
career professionals for teaching positions in high-poverty school
districts. Allowable activities would include post-placement induction
programs to support new teachers once they begin teaching, through
mentoring and other activities that build upon their teacher
preparation training.
Grantees could use program funds to provide each program
participant with up to $5,000 in training stipends and other financial
incentives, including moving expenses. Participants who complete
training would teach in a high-poverty school district for at least 3
years; those participants who received a training stipend or other
financial incentives but fail to meet their service obligation would be
required to repay all or a portion of the stipend.
IMPACT AID FUNDING AND THE ADMINISTRATION'S CONSTRUCTION PROPOSAL
Question. Your budget again contains what can only be described as
a paltry request for Impact Aid funding, particularly with regard to
the critical construction needs at many of our coterminous and other
Impact Aid school districts, the buildings of which are in many cases
owned by your Department. How can you support an unprecedented and
costly new role of the Federal Government in funding school
construction when your Department and your Administration have
completely neglected the construction needs of the school buildings you
own, which are used to educate tens of thousands of children, including
the children of members of the armed services and Native American
children?
Answer. We believe that money can and should be spent concurrently
on both schools that are federally owned and those that are not. All of
the schools that are currently owned by the Department are located on
military bases and are used by local school districts for educating
children whose parents are typically members of the uniformed services.
The Administration requested $5 million, the same amount as Congress
appropriated for fiscal year 2000, for Facilities Maintenance in order
to upgrade and transfer school facilities to school districts, which
can manage school buildings more effectively than can the Federal
Government. In addition, these funds would be used to perform emergency
repairs to those school buildings that have not yet been transferred.
The Administration is also concerned about the poor condition of
school facilities that are not owned by the Department but are used to
educate our Nation's children, particularly American Indian children.
The General Accounting Office estimates that it would cost $112 billion
to bring our Nation's public schools into good overall condition. The
Administration's School Renovation proposal would help meet this need
by financing school renovation in communities that lack the resources
to repair their schools. The proposal would reserve $50 million out of
the $1.3 billion for approximately 118 Impact Aid local educational
agencies (LEAs) that have 50 percent or more of their students residing
on Indian lands. These LEAs lack the resources to undertake urgently
needed renovations, such as roof or plumbing repairs and upgraded
climate-control systems. The balance of the funds requested under the
proposal would go to school districts that similarly lack the resources
to meet their urgent school construction needs.
______
Questions Submitted by Senator Herb Kohl
FLEXIBILITY OF BLOCK GRANTS OVER TARGETED PROGRAMS
Question. Mr. Secretary, I want to commend you for your commitment
and hard work on behalf of our Nation's public school children. Since
1994, we have made some important gains in raising the achievement of
students. Unfortunately, I think we share the same concerns that
academic achievement has not been raised enough, and that the gap
between economically disadvantaged and more affluent students remains
alarmingly and inexcusably large.
As you know, we have a full menu of Federal education programs
today. Most are focused on very specific issues. I am concerned,
however, that we have gotten away from what I believe is the Federal
Government's central role as a partner in education: helping States and
school districts lift academic achievement for all students, and
eliminating the achievement gap between poor and affluent students. I
am concerned that the current structure of Federal education programs--
that is, to create a new program to address each and every education
issue--actually results in spreading Federal dollars too thin to be
useful for local educators.
For example, one school district might need more money to buy
computers, but they might not have any pressing safety issues to
address. Another school district might have a sufficient number of
after-school programs, but they might really need more funding for
school counselors. Under the current structure of ESEA, these school
districts have little flexibility to move Federal money around. That
means one of two things: either they get too little money to address
their biggest problems, or they miss out on money from some Federal
programs because those programs have no relevance for their schools.
Don't you agree that States and local school districts are in the
best position to know what their education needs are and to devise ways
to address them?
Answer. I absolutely agree that States and communities are in the
best position to address their education needs, and that the Federal
role is that of a junior partner. I also believe that Federal programs
provide more flexibility than is commonly recognized. For example, the
Goals 2000 State Grant program provides funds that can be used for a
very wide variety of activities that support standards-based reform,
from teacher training to curriculum to buying computers. Title I funds
also support many different approaches to improving student
achievement, including early childhood education, adoption of research-
based reform models, after-school programs, and school safety efforts.
Question. Isn't it possible that consolidating many Federal
education programs would actually give States and school districts even
more resources to pour into their most pressing needs?
Answer. Our experience with block grants has shown that this
approach is what really leads to funds being spread too thinly to have
much impact. In fact, in a recent report from the General Accounting
Office on the Goals 2000 program, State officials expressed concern
that if Goals 2000 funds were not restricted to support of State and
local standards-based reform efforts, they would be diverted to non-
reform activities.
Question. Isn't it possible that allowing maximum flexibility to
move Federal money around might result in some of these needs being
better met?
Answer. It is possible, but in my view--and I say this as a former
governor--not likely. I think it is important to remember that we are
trying at the Federal level to exercise leadership and stimulate
change. One reason this is so hard is that people everywhere--and not
just in our schools--tend to keep doing things the same way, the way
they are comfortable with. In my view, the ``maximum flexibility'' you
are talking about would only encourage this kind of educational
inertia.
The American people have made clear their support for more
investment in critical national priorities--like smaller class sizes,
expansion of after school programs, improving reading in the early
grades, and helping students and their families get ready for college.
It is precisely because our role--and our resources--are limited that
we must target the Federal education investment to those areas where it
can make a real difference. At the same time, we continue to work to
provide the flexibility districts and schools need to raise student
achievement, while ensuring accountability for the effective use of
taxpayer funds.
TURNING AROUND FAILING SCHOOLS
Question. As you know, we have over 7,000 failing schools in our
country. For years, regardless of the fact that they consistently fail
to educate children, they continue to receive a steady stream of
Federal money. In effect, we are subsidizing their failure. I believe
that failing schools should be given the tools they need to turn
themselves around--and successful schools should be rewarded for their
hard work. However, at some point, I believe we actually do more harm
than good for children when we continue to subsidize schools that fail
to educate them.
What do you believe should be done with chronically failing
schools?
Answer. Greater accountability is at the core of our proposal to
reauthorize the Elementary and Secondary Education Act (ESEA). The
Administration's reauthorization bill would strengthen statewide
accountability systems, provide new resources for States and school
districts to turn around failing schools, and require tough measures
for chronically failing schools. For example, schools in corrective
action under Title I could be reconstituted with a new staff and
curriculum or actually closed down and reopened as a new school or as a
charter school.
Question. Does the Administration believe that at some point there
must be real consequences for schools that can't or won't improve?
Answer. Yes, we do. In addition to our reauthorization proposals,
we are implementing the new Title I Accountability Grants program,
which couples additional resources for school improvement efforts with
the requirement that gives students in schools identified for
improvement under Title I the option to attend a better school. Our
2001 budget proposal would require all school districts participating
in Title I to give students attending schools identified for corrective
action the option of transferring to a school not identified for
corrective action.
Question. Doesn't the Federal Government have a responsibility to
taxpayers not to subsidize failure?
Answer. I believe we do, and so does President Clinton. This is why
he took the lead more than a year ago to launch a broad-based
accountability initiative that includes the measures described above.
Other proposals to increase accountability, such as report cards for
parents and tougher qualifications for teachers and paraprofessionals,
have been incorporated into the President's ESEA reauthorization bill.
______
Questions Submitted by Senator Patty Murray
CLASS SIZE REDUCTION PROGRAM--TEACHERS HIRED
Question. Mr. Secretary, the President has requested an additional
$1.75 billion to maintain our goal of hiring 100,000 new teachers to
address the severe problem of overcrowded classrooms. Opponents of this
funding have argued that these funds may not be accessible for all
school districts and may never make it to the classroom. Can you
provide for us a brief status report on how many teachers have been
hired to date and how many we could hire with the additional $1.75
billion?
Answer. Based on data from 55 percent of districts, we estimate
that local districts have used their 1999 Class Size Reduction funds to
hire more than 29,000 teachers.
We estimate that the $1.75 billion budget request for the program
in 2001, along with the 35 percent local matching requirement, would
support the hiring of as many as 49,000 teachers. Without the local
matching requirement, the requested amount would support the hiring of
as many as 43,000 teachers.
TECHNOLOGY LITERACY CHALLENGE FUND PROGRAMS AND PREPARING TOMORROW'S
TEACHERS TO USE TECHNOLOGY
Question. Mr. Secretary, as you are aware, I have focused not just
on class size but also working to make sure we give teachers the skills
to use technology in the classroom. It does little good to wire every
classroom to Internet or to provide Internet access to every school if
teachers are not prepared to use these tools in the classroom. Can you
provide a brief summary of the President's Technology Literacy
Challenge Fund activities as requested in his fiscal year 2001 budget?
Answer. In 2001, we are requesting a total of $450 million for the
Department's Technology Literacy Challenge Fund (TLCF) program, an
increase of $25 million. The TLCF helps local districts put into place
strategies to enable all schools to integrate technology fully into
school curricula to improve teaching and learning. The Department's
proposal for reauthorization of the TLCF would limit eligibility for
awards to districts with high concentrations of poor children and a
demonstrated need for technology, or to partnerships that include such
districts. Districts would use their funds to increase the capacity of
teachers in high-poverty, low-performing schools to use technology
effectively in their classrooms. The amount requested would support
approximately 3,400 local grants.
In addition to the TLCF, the Department's other educational
technology programs help States, districts, and schools achieve the
four goals of the Administration's Technology Literacy Challenge, which
are to: (1) provide access to modern, multimedia computers for all
teachers and students; (2) connect every school and classroom to the
Internet; (3) provide all teachers with the training and support they
need to use technology effectively in their classrooms; and (4) develop
effective and engaging software and on-line resources as an integral
part of schools curriculum. The technology programs and the 2001
requested amounts are:
--Next-Generation Technology Innovation, for which we are requesting
$170 million in 2001, would replace the current Technology
Innovation Challenge Grants and Star Schools programs. The new
program would focus on developing ``cutting edge'' applications
of educational technology. In 2001, new awards would focus on
developing advanced technology applications, supporting the
development of high-quality on-line coursework, and a special
initiative to help prepare middle school teachers in the
Mississippi Delta region to use technology effectively and to
develop challenging coursework on-line.
--Preparing Tomorrow's Teachers To Use Technology assists public and
private entities to develop and implement teacher training
programs that prepare prospective teachers to use technology to
improve instructional practices and enhance student learning.
The $150 million requested in 2001, a $75 million increase over
2000, would support approximately 466 awards.
--Community Technology Centers supports efforts to establish or
expand technology centers to provide residents of impoverished
rural and urban communities with access to computers and
technology, particularly educational technology. The $100
million requested in 2001, a $67.5 million increase, would
allow approximately 400 communities to establish or expand
1,000 technology centers.
--Regional Technology In Education Consortia, for which we are
requesting $10 million, the same as the 2000 appropriation,
supports regional centers that carry out professional
development, resource and information dissemination, and
technical assistance to help States, districts, and schools
integrate technology effectively into classrooms.
--Ready To Learn Digital Television, for which we are requesting $16
million in 2001, supports the development of educational
television programming and related activities aimed at
cultivating a love of language, reading, and learning in young
children.
--Telecommunications Program For Professional Development, for which
we are requesting $5 million in 2001, would replace the current
Telecommunications Demonstration Project for Mathematics
program. This new program would support telecommunications-
based projects designed to provide professional development to
elementary and secondary school teachers in the core academic
subjects.
STUDENT DEBT--GROWING IMBALANCE OF STUDENT EDUCATION LOANS TO GRANTS IN
PAYING FOR COLLEGE
Question. Over the past 10 years, I have witnessed a disturbing
trend in higher education. We have a growing number of students who
must depend entirely on borrowing in order to pay for their higher
education. The percentage of loans versus direct grants to students has
dramatically increased. Students are graduating with huge debts and
many discontinue or do not pursue a postsecondary education simply out
of fear of carrying such a large debt. In addition, many students are
looking at careers based on starting salary because they know they will
have large loan payments. I realize this problem cannot be solved in
one budget cycle, but I would welcome your thoughts on steps we can
begin to take to reverse this trend.
Answer. One of the major steps we need to take is to continue
increasing support for the Pell Grant program, where the maximum award
has risen from $2,300 in fiscal year 1994 to $3,300 in fiscal year
2000. The maximum Pell Grant in fiscal year 2000 covers about 95
percent of the average tuition and fees at a 4-year public college, but
still only about 38 percent of the total cost of attendance. This
program is vital to the overall student aid picture, as is funding for
campus-based programs such as Federal Work-Study where an estimated 1
million students will help earn their way through college with Federal
assistance in fiscal year 2000.
We need to do a better job of counseling students up front on what
amount of borrowing is appropriate to their specific situation. We also
can encourage States and institutions to increase their level of
assistance so that students may take advantage of available non-Federal
aid as well.
Many students who are dependent on borrowing may be ineligible for
grant aid due to family income levels. We, too, are concerned about the
rising loan debt that numbers of these and other postsecondary students
are carrying. One of our performance measures focuses on keeping median
Federal debt burden below 10 percent of income in the first year of
repayment. While this is not entirely within the Department's control,
since many outside factors play a role, there are options that we have
instituted to help borrowers manage their debt.
For instance, the Administration established flexible repayment
plans such as Income Contingent Repayment, which allows Direct Loan
borrowers to repay based on size of debt and income. Other options
include graduated, extended, and income sensitive repayment plans that
can help make monthly payments more affordable and keep borrowers out
of default.
EDUCATIONAL TAX INCENTIVES
In addition, we need to encourage eligible students and their
families to use the variety of educational tax incentives available.
For instance, taxpayers may be able to deduct up to $2,000 in student
loan interest in 2000. Hope and Lifetime Learning tax credits are
another possibility to lower overall postsecondary tuition and fee
expenses. The Hope tax credit allows up to $1,500 annually toward
tuition and fees paid in the first 2 years of postsecondary education
and the Lifetime learning tax credit currently permits up to $1,000.
The Administration is seeking to expand the Lifetime learning tax
credit up to $2,800 annually and raise the income phase-out ranges so
greater numbers of families can take advantage of it.
In combination, all of the ways mentioned above, represent positive
steps that can help in alleviating the burden of student loan debt.
______
Questions Submitted by Senator Robert C. Byrd
BYRD SCHOLARSHIP PROGRAM
Question. Over the life of the program, how many students have
received Byrd Scholarships and how many new and continuing awards have
been made?
Answer. Since the program was first funded in fiscal year 1987,
76,376 students have received Byrd Scholarships and a total of 173,897
new and continuing awards have been made. In fiscal year 2000, 26,572
new and continuing scholarships will be made and in fiscal year 2001,
our budget would provide an additional 7,310 new scholarships and
20,024 continuing scholarships.
DEPARTMENT OF EDUCATION EXPENDITURES FOR NEEDS-BASED STUDENT FINANCIAL
ASSISTANCE
Question. In 1999, how much did the Department of Education spend
on needs-based student financial assistance?
Answer. In 1999, the Department obligated nearly $7.7 billion in
the Student Financial Assistance account in support of need-based
student aid. Those funds, together with required matching funds under
the Campus-Based and Leveraging Educational Assistance Partnership
(LEAP) programs, less allowable administrative costs, provided an
estimated $10.2 billion in available aid to students. With an
additional $15.7 billion in need-based mandatory student loans
(guaranteed and direct subsidized Stafford loans), the Department made
approximately $25.9 billion in need-based aid available to students in
1999.
Obligations in the SFA Account in Fiscal Year 1999
Pell Grants............................................. $6,043,864,720
Campus-based programs:
SEOG................................................ 619,307,364
Work-study.......................................... 875,536,832
Perkins loans:
Federal capital contributions....................... 101,662,353
Teacher cancellations............................... 29,980,923
LEAP.................................................... 25,000,000
--------------------------------------------------------
____________________________________________________
Total obligations............................... 7,695,352,192
DEPARTMENT OF EDUCATION EXPENDITURES FOR MERIT-BASED STUDENT FINANCIAL
ASSISTANCE
Question. How much did the Department spend in the same year for
merit-based student financial assistance?
Answer. In addition to $39.3 million in the Byrd Honors
Scholarships program for merit-based financial assistance to
undergraduate students, in fiscal year 1999, the Department spent a
total of $31 million in the Graduate Assistance in Areas of National
Need (GAANN) and Javits Fellowships programs for merit-based assistance
to graduate students studying in areas of national need and doctoral
students studying in the arts, humanities, and social sciences.
REWARDING EXCELLENCE IN STUDENT FINANCIAL ASSISTANCE
Question. The purpose of the Byrd Scholarship program is to award
students who work hard at their schoolwork regardless of economic
factors. How does the Department of Education intend to build upon
these efforts to reward excellence?
Answer. The Administration's fiscal year 2001 budget request
recognizes the success of the Byrd Honors Scholarships program in
helping high achieving students pay for a college education and would
build on this success by moving the program closer to the maximum
funding level authorized by law. In addition, the budget request would
continue support for the GAANN and Javits Fellowships programs because
of their critical role in rewarding excellence and encouraging
continued learning.
SCHOOL CONSTRUCTION
Question. With the Elementary and Secondary Education Act due to be
marked up by the Senate Health, Education, Labor, and Pensions
Committee this week, I would like now to turn to those issues of
importance to students, parents, and teachers in creating a stronger,
more educated national population. I strongly believe that educating
oneself is a lifelong journey, and the skills by which one learns to
read and study are fostered at a young age, making these years of
schooling extremely important in shaping one's future pursuit of
education. Mr. Secretary, would you please respond to the following
questions.
I have noted the Department's new efforts to increase budget
spending for school construction. Specifically, how will these
projections assist our small, rural schools in high poverty areas such
as we find in my State of West Virginia?
Answer. The Administration's School Renovation proposal would
provide $1.3 billion in grants and loan subsidies to provide support
for urgent renovations in areas of high need. These funds would assist
schools in high poverty areas, such as those in small, rural areas of
West Virginia, because they would be targeted to school districts based
on poverty rates, school repair needs, and fiscal capacity.
Question. When available construction funding requires matching
funds, how does the Federal Government assist the small rural
communities with high poverty levels and low tax bases to be
competitive?
Answer. The Administration's School Renovation proposal would
provide both grants that require no matching funds and subsidies equal
to the size of interest payments on 7-year loans. The Administration
intends to target both the grants and the loans to needy areas, while
reserving the grants for areas with the greatest need.
TEACHER CERTIFICATION--NATIONAL BOARD FOR PROFESSIONAL TEACHING
STANDARDS
Question. Are there any national efforts to encourage teachers to
participate in the National Board for Professional Teaching Standards
certification process?
Answer. The National Board for Professional Teaching Standards
(NBPTS) itself encourages participation in the certification process in
several ways. One way is through Teacher Subsidies (funded at $2.5
million of the Department's grant to the Board). The Board provides
funds to each State to pay up to one half of the candidate fee. As a
result of the program, staff in the departments of education in each
State engage in a variety of strategies to increase the number of
teachers in their States who are seeking certification. The Board also
sponsors a series of national facilitator institutes for individuals
interested in helping recruit candidates and providing support for
candidates going through the certification process.
The Board has also partnered with national organizations such as
the Council of Great City Schools, the National Council of Social
Studies, the International Reading Association, and the National
Alliance of Black School Educators to increase participation. The Board
has exhibits at the national conferences of many major education and
content associations. In addition, the Board works with the private
sector to increase participation; e.g., State Farm is supporting
candidates through its offices in each State.
Question. How can we assist States with very low numbers of
participating teachers?
Answer. In those States with large numbers of National Board
Certified Teachers (NBCT), there is significant State support through
financial incentives, including fee support and salary increases,
coupled with an increased awareness of the NBCT process. The reverse is
true in those States with low numbers of National Board Certified
Teachers.
Through its grant to the NBPTS, the Department is helping to
increase the number of candidates for National Board Certification in
States with low participation by providing support to the Board:
--to increase State and local incentives through meetings with State
stakeholders and legislators; and
--to increase awareness of the NBCT process through partnerships with
the private sector, encouragement of candidate support groups,
participation in national meetings involving teachers, and
working with ED's Regional Educational Laboratories and
institutions of higher education.
teacher shortages and the budget proposal
Question. With the incredible predictions for teacher shortage
rates growing almost daily, what efforts might we expect to see
emerging to reverse this threatening crisis?
Answer. The Administration shares your concern about reports that
many school districts are having difficulty hiring and retaining fully
qualified teachers. According to the National Commission on Teaching
and America's Future's report, What Matters Most: Teaching for
America's Future (1996), ``Much of the problem of teacher supply is a
problem of distribution that could be solved with more thoughtful and
coherent policies. While there are shortages of qualified candidates in
particular fields (e.g., mathematics and science) and particular
locations (primarily inner city and rural), the nation each year
produces more teachers than it needs. . . . Thousands of teachers fail
to make the transition from the places they were prepared to the places
where the jobs are due to lack of information about where to apply,
lack of reciprocity in licensing between States, and ridiculously
cumbersome application procedures.'' (pp. 37-8)
In addition, the report concludes that inadequate efforts to retain
teachers contribute to the teacher shortage. For example, the report
states that ``Of all of education's self-inflicted wounds, the
continued tolerance for extraordinary turnover among new teachers is
among the most remarkable. Chronic, high rates of teacher replacement--
particularly for teachers in the first 2 or 3 years of their careers
and particularly in urban school districts--increase the pressure on
teacher recruitment and initial placement systems incessantly. . . .
Turnover in the first few years is particularly high because new
teachers are typically given the most challenging teaching assignments
and left to sink or swim with little or no support. They are often
placed in the most disadvantaged schools and assigned the most
difficult-to-teach students, with the greatest number of class
preparations (many of them outside their field of expertise) and a slew
of extracurricular duties. With no mentoring or support for these
teachers, it is little wonder that so many give up before they have
really learned to teach.'' (p. 39)
The Administration is requesting funds for several programs to help
school districts address their immediate teacher shortage concerns,
including a proposed new initiative, Hometown Teachers, and the
Transition to Teaching program. We believe that these and other teacher
training programs, for which we are requesting a total of $1 billion,
would encourage school districts to develop and implement longer-term
solutions for recruiting and retaining high-quality teachers. For
example, States and school districts would be able to use funds to
develop strategies that could include mentoring programs for new
teachers, higher teacher salaries, more desirable working conditions,
better professional development opportunities for teachers and school
leaders, and other efforts to improve the quality of the teaching
profession.
DEPARTMENTAL RESPONSE TO TEACHER SHORTAGES
Question. What is the Department doing to specifically address
these issues?
Answer. The Administration is requesting $1 billion in support of a
comprehensive set of ESEA reauthorization proposals focusing on
professional development and teacher recruitment. Programs that would
be implemented as part of the package include Teaching to High
Standards State Grants (which would replace the Eisenhower Professional
Development State Grants and Goals 2000 programs), a School Leadership
Initiative, National Activities for the Improvement of Teaching and
School Leadership, the Eisenhower Regional Mathematics and Science
Education Consortia, Teacher Quality Initiatives, Transition to
Teaching: Troops to Teachers, and Early Childhood Educator Professional
Development.
The Administration believes that these programs, in total, would
help States and school districts address their teacher shortages both
directly and indirectly by helping them to develop and implement short-
and long-term solutions to teacher recruitment issues and to reduce
their teacher attrition rates. In addition to the programs that
specifically address teacher recruitment, such as the Hometown Teachers
and Transition to Teaching programs, other programs in the $1 billion
request would provide high-quality professional development to both
teachers and school leaders to help ensure that all students are being
taught by teachers who are fully qualified and who are receiving the
support they need to teach to challenging State and local standards.
For example, the Administration is requesting $690 million for the
Teaching to High Standards State Grants program, which would help
educators improve learning in American classrooms by supporting State
and local efforts to align curricula and assessments with challenging
State and local content standards and to provide teachers with
sustained and intensive high-quality professional development in the
core academic subjects. A $60 million set aside in this program would
provide grants to colleges and universities that agree to partner with
at least one school district to provide professional development in the
core academic subjects. States would be required to give priority to
those colleges and universities that plan to focus on induction
programs for new teachers that provide mentoring and coaching by
trained mentor teachers. The Administration believes that induction
programs such as these can provide the support that new teachers need
to help them to become more effective teachers and to improve the
likelihood that they will stay in the teaching profession.
RECOGNIZING HIGHER EDUCATION INSTITUTIONS WITH EFFECTIVE ALCOHOL AND
DRUG PREVENTION PROGRAMS
Question. As you recall, I authored a component of the Higher
Education Act Amendments of 1998 to establish a National Recognition
Awards program to identify institutions of higher education with
effective alcohol and drug prevention programs. With the first year of
the program complete, would you please provide me with a report on the
second year's implementation status of the program, as well as any
intentions the Department may have to broaden the program given the
increase in funding?
Answer. Because the second year of the program is being funded
under a different authority than last year (that is, under Safe and
Drug-Free Schools National Programs rather than under the Fund for the
Improvement of Postsecondary Education), the Department has needed to
undergo rulemaking to implement the program for 2000. On February 14,
2000, the Department published in the Federal Register a notice of
proposed priority, eligible applicants, and selection criteria for
evaluating applications for new grants under for this program. We
received very few comments from the public and expect to publish a
final notice in the Federal Register in early April, at which time we
will begin soliciting grant applications from institutions of higher
education. The application deadline date will be May 12, 2000. The
program will be operated in essentially the same manner as it was
implemented in 1999.
The Department is planning to use the additional $100,000 in 2000
funds to make additional awards and to support enhanced dissemination
activities by each grantee. A total of $600,000 will be available for
awards (compared to $500,000 in fiscal year 1999). Once again $250,000
of the appropriation will be used to administer the peer review
process, conduct a recognition ceremony, and develop and disseminate a
publication describing the model programs. We plan to make grant awards
in June, and anticipate making between eight and ten awards, ranging
from $50,000 to $90,000 each.
______
Questions Submitted by Senator Dianne Feinstein
TITLE I HOLD HARMLESS
Question. You have given important opposition to the Title I ``hold
harmless'' provision that effectively negates the law's requirement
that the Department use the most up to date child poverty data in
allocating Title I funds. Hold harmless provisions freeze in amounts to
States whether the number of poor children goes up or down. In fast-
growing States like mine, the hold harmless hurts and we don't get our
fair share. California lost $40 million in fiscal year 2000 because of
the hold harmless. California received $944.9 million instead of the
$984.5 million we should have received.
Will you vigorously oppose the hold harmless publicly?
Answer. I could not agree with you more on the harmful impact of
the 100 percent hold-harmless on Title I allocations. This provision
does indeed prevent Title I funds from flowing, as intended by the
authorizing statute, to States and school districts experiencing rapid
growth in poor students. Research shows clearly that high
concentrations of school poverty are directly correlated with low
student achievement, and that even non-poor students tend to perform
poorly in schools with high poverty levels. This is why the various
Title I formulas are designed to target additional resources to high-
poverty districts and schools. Unfortunately, in many cases the 100
percent hold-harmless provision undermines this targeting and dilutes
the impact of the $8 billion annual investment in Title I. Our budget
would eliminate this provision, and we certainly will support efforts
by you and others to resist the continuation of this 100 percent hold-
harmless requirement in the fiscal year 2001 appropriation.
STRENGTHENING TITLE I ACCOUNTABILITY PROVISIONS TO INCREASE ACADEMIC
ACHIEVEMENT
Question. Current law has some accountability requirements for the
Title I program, yet I question whether there have been real
achievement gains under the current program. I know you agree that the
early years--learning the basics--are critical to a student's lifetime
success.
How can we strengthen Title I's accountability requirements to make
sure the funds are spent on improving learning in the core academic
curriculum?
Answer. As I indicated earlier, greater accountability is at the
core of our proposal to reauthorize the Elementary and Secondary
Education Act. We would strengthen statewide accountability systems to
ensure that Title I schools are held to the same high standards as
other schools, provide new resources for States and school districts to
turn around failing schools, and require tough measures for chronically
failing schools. We also would require tough corrective actions for
chronically failing schools, including reconstituting them with a new
staff and curriculum or actually closing them down and reopening them
as a charter school.
REAUTHORIZATION PROPOSAL TO INCREASE TITLE I ACCOUNTABILITY
Question. What are your proposals?
Answer. The Administration's reauthorization proposal for Part A of
Title I would encourage each State to develop a single, rigorous
accountability system that holds all local educational agencies (LEAs)
and schools, including Title I schools, accountable for making
continuous and substantial gains in student performance and in the
performance of the lowest-performing students. This statewide
accountability system would be based on the State's content and student
performance standards, and would include procedures for identifying and
intervening in LEAs and schools that are not making gains in student
performance, as well as recognition and rewards for successful LEAs and
schools. States that do not operate such a system for all their schools
would be required to develop one for their Title I schools.
The Administration's reauthorization proposal includes strong
corrective actions to turn around consistently low-performing schools.
Once a Title I school is designated for corrective action, the LEA
would be required to carry out one of the following measures: (1)
implement a new curriculum that research has shown offers substantial
promise of improving student achievement; (2) redesign or reconstitute
the school, which may include reopening it as a charter school; or (3)
close the school and allow its students to transfer. Districts also
could allow students in schools subject to corrective action the option
of transferring to a new school.
The Administration's reauthorization bill also includes a proposal
to provide additional resources to States and school districts to
support school improvement efforts. The fiscal year 2000 Department of
Education Appropriations Act jumpstarted this new initiative by
providing $134 million for school improvement activities at the LEA
level. These funds must be used for technical assistance and other
interventions designed to improve low-performing schools and to help
such schools enable all students to meet challenging State standards.
In addition, Congress directed, through appropriations language, that
all LEAs receiving these funds must provide students enrolled in
schools identified for improvement with the option to transfer to
another public school within the LEA that has not been identified for
improvement.
The President's 2001 budget would expand funding for these new
accountability grants to $250 million, with 30 percent of grant funds
reserved for State-level accountability and school improvement
activities and 70 percent allocated to LEAs. And to help ensure that no
student is trapped in a chronically failing school, the
Administration's 2001 budget proposal would require LEAs to give
students attending corrective action schools the option of attending
another public school within the LEA that has not been identified for
corrective action. This requirement would apply to all LEAs
participating in Title I, whether or not they receive accountability
grant funds.
IMMIGRANT EDUCATION FUNDS
Question. Under the immigrant education programs, the Department of
Education awards grants to school districts based on the number of
immigrant children enrolled, if the district has an immigrant
population of at least 500 or 3 percent of their enrollment. Students
counted are those that have been in this country for less than 3
academic years.
New immigrant students are probably the most at-risk students. In
addition to language barriers, their schooling has been interrupted and
they are in unfamiliar communities.
Funding for this program has been flat--at $150 million in 1998,
1999, and 2000. And you have requested $150 million for fiscal year
2001. California has 25 percent of the U.S. legal immigrants and 40
percent of the Nation's illegal immigrants. Last year California
received $36.5 million to educate immigrant children.
In light of the serious needs these children bring to the
classroom, shouldn't we be increasing immigrant education funds?
Answer. We strongly agree that school districts need Federal
assistance in serving recent immigrant students. The Administration
proposed, and Congress enacted, increased funding for this program in
each of fiscal years 1996, 1997, and 1998. However, since 1995, the
number of eligible immigrant students in the Nation has declined by 2
percent, and in California by 29 percent. With this decline, we believe
that the proposed appropriation level is adequate. As you know, for
2001, the Administration has proposed large increases for both the
Title I and Bilingual Education programs that serve large numbers of
immigrant students.
FLEXIBILITY OF CLASS-SIZE REDUCTION PROGRAM
Question. The Clinton Administration's push to reduce class sizes
in the lower grades is a good use of Federal education funds.
California has been reducing class sizes in grades K-3 since the 1996-
1997 school year. Because these efforts have largely succeeded in
reducing class sizes in grades 1-3, in fiscal year 2000 California
received a waiver that allowed my State to use class-size reduction
funds to reduce class sizes in higher grades.
Will you accommodate States that have taken the initiative in
reducing class size by making funds flexible enough to suit the
specific class size reduction needs of the State?
Answer. Districts have considerable flexibility in the use of their
Class Size Reduction funds. A district that has met the target level of
18 children or fewer in the early grades, or has reduced class size to
a State or local class size reduction goal that was in effect prior to
November 29, 1999, can use its funds to further reduce class size in
those grades, to reduce class size in additional grades, or to improve
teacher quality. We will work with States to provide them with
flexibility in the use of the funds they receive under the Class Size
Reduction program so that each State is able to address its specific
class-size reduction needs.
REDUCTION IN IMPACT AID
Question. Impact Aid is an important program without which many
schools in California and other States would be in severe financial
straits. Currently in California, $57 million in Impact Aid is spent
educating 1 million students in 119 school districts. Impact Aid is a
basic obligation that the Federal Government has to school districts to
compensate them for the lost revenues because of tax-exempt Federal
property. More than half of the Administration's proposed $128 million
cut in Impact Aid comes from the elimination of the ``Payments for
Heavily Impacted Districts.''
Why did the Administration propose a drastic $128 million, or 15
percent, cut in Impact Aid?
Answer. In the Administration's budget, the types of Impact Aid
funds that are targeted to the school districts with the clearest needs
would increase. For example, Basic Support Payments on behalf of an
Impact Aid ``a'' child would increase 7 percent on average from the
2000 level. (Impact Aid ``a'' children are generally those children who
reside with their parents who both live and work on Federal land.
Impact Aid ``b'' children are generally those students who reside with
their parents who work or live on Federal land.) Under the
Administration's proposed funding level and formula, the Department
estimates that school districts in California would receive an increase
of nearly 10 percent in Basic Support Payments, from $51.8 million in
2000 to $56.6 million in 2001.
The Administration's budget does not support payments on behalf of
``b'' children because we believe (as did previous Administrations)
that ``b'' children do not present a real, uncompensated burden for
school districts. Families that reside on private property either pay
property taxes or rent property on which their landlords pay property
taxes. Since local governments typically finance education using
property taxes, the local cost of educating off-base children can be
financed using property and other local taxes.
The Administration proposes no funding for Payments for Heavily
Impacted Districts because the program no longer meets its purpose
under the authorizing statute--to assist school districts with large
proportions of federally connected students and a strong tax effort in
reaching the per-pupil expenditures of similar school districts in
their State. The appropriations for fiscal years 1999 and 2000
essentially rewrote both the eligibility criteria and the payment
formula for this supplemental funding authority.
The program now functions more as a set of funding earmarks than a
legitimate program meeting a genuine need. No school districts in
California receive Payments for Heavily Impacted Districts.
By eliminating funding for authorities that fail to meet their
intended purpose, the Administration is able to focus on funding
increases for high priorities, such as a substantial increase for
payments on behalf Impact Aid ``a'' children under the Basic Support
Payments formula.
PAYMENTS FOR HEAVILY IMPACTED DISTRICTS
Question. Why, if the Department of Education believes that the
funds for heavily impacted schools are not targeted effectively, does
the Department not try to change the legislation rather than simply
cutting the funding in its entirety?
Answer. The Administration is proposing changes to the legislation
for Payments for Heavily Impacted Districts in its proposal for
reauthorizing the Elementary and Secondary Education Act. However,
neither the Senate nor the House committee bills to reauthorize Impact
Aid include these changes.
The Administration's proposed changes would simplify the payment
formula and bring this program back to its original purpose of
assisting school districts with large proportions of federally
connected students and a strong tax effort to increase their per-pupil
expenditures so that they would be in line with similar school
districts. These changes would discontinue the practice of distributing
these funds to school districts that no longer have large proportions
of federally connected children.
HEAD START PROGRAM
Question. Should the Head Start program be moved to the Department
of Education and converted to a strong preschool program?
Answer. I see no reason to move the Head Start program to the
Department of Education. Head Start, as it now exists, is a strong
program that helps prepare our highest need children to succeed in
school. The Department of Health and Human Services (HHS) has worked to
ensure that Head Start is a comprehensive program that integrates
health and social services with education and learning and is geared
toward promoting both social competence and school readiness for our
Nation's low-income children. With the greater focus on improving the
standards and quality of all aspects of Head Start in the last
reauthorization, HHS has worked hard to focus on improving quality,
including the improvement of key school readiness indicators.
In 1998, the National Academy of Sciences released information
about critical research on the importance of preventing reading
difficulties in young children by focusing efforts on improving
opportunities for young children to develop language and literacy
skills in preschool in order to enter school ready to learn to read.
The Department of Education has worked closely with HHS to focus
Federal early childhood programs on this goal and to disseminate this
research widely. These efforts have focused on improving the language
and literacy skills of young children through the Head Start, Title I,
Even Start, and Reading Excellence programs. I am confident that we
will make great strides in helping all young children, especially those
from poor families, improve their reading readiness.
Question. Would the program be a stronger program if moved to the
Department of Education?
Answer. Again, I see no reason to move the program. Both of our
agencies are working together to ensure that young children are able to
start school ready to learn--by offering a wide range of approaches and
services to reach the young children who are most at risk of school
failure, by encouraging parents to become involved in their young
children's development, and by stressing the importance of cognitive
development in young children. We have learned some important lessons
in recent years about how to meet the range of needs of target families
and how to manage our programs more effectively.
HHS AND ED COORDINATION ON HEAD START
Question. What is the coordination between HHS and ED vis-a-vis
Head Start?
Answer. The Department of Education (ED) and the Department of
Health and Human Services share the mission of providing services to
young children in order to ensure that they are healthy, safe, and able
to start school ready to learn. During the past 7 years, our agencies
have worked to improve collaboration and communication in order to
serve our Nation's children more effectively. While significant strides
have already resulted from this increased interagency collaboration, we
will continue our efforts to improve program efficiency and
accountability. Some examples of ways in which ED is working with HHS,
specifically in the areas of early childhood services, research, and
performance measures are:
In the area of School Age Care and After School Programming, ED and
HHS have collaborated on several successful programs, including the
Federal Support to Communities Initiative (FSC), Safe School/Healthy
Students, 21st Century Community Learning Centers, and Child Care and
Development Block Grants (CCDBG). These programs address the growing
need to provide stimulating out-of-school-time programs for our
Nation's children.
In the area of accountability at the Federal level, Title I, Even
Start, Head Start, CCDBG, and the Individuals with Disabilities Act
(IDEA) programs are developing outcomes systems for use in improving
program effectiveness and complying with the Government Performance and
Results Act of 1993 (GPRA). As a next step toward coordinated
indicators and measures, ED and HHS will conduct an assessment of the
scope, quality, and frequency of measurement of the current set of ED
and HHS program performance indicators for their early childhood
programs. Included in this analysis will be a comparison of the GPRA
indicators for the programs, as well as the studies, reporting systems
and evaluations, and measures used to report on the indicators and
evaluate the programs.
Even Start, Title I, and Head Start staff are coordinating programs
on a number of fronts by focusing on ways to sustain coordination
efforts at the Federal, State, and local levels. For example, Federal
Even Start and Head Start staff are planning a joint conference for the
summer of 2000 on coordinating accountability systems. This conference
will include staff from Head Start State Collaboration Offices and Even
Start Statewide Family Literacy Initiative grants, in addition to other
key State offices involved in early care, education, and family
literacy. In addition, ED and HHS will soon issue guidance on models
for collaborating and blending Head Start, Special Education, Even
Start, and Title I, Part A funds (i.e., models for combining funds to
provide whole-day and year-round preschool services, or models with
Title I paying for educational services and Head Start paying for
health, nutrition, and parent involvement). Also, HHS and ED are
exploring ways to provide joint family literacy technical assistance
through the Head Start Family Literacy Technical Assistance Initiative.
HHS is also partnering with ED in the development of ED's Survey of
Early Care and Education Programs, a nationally representative sample
of child care providers and early childhood programs serving children
under the age of six. This project is the first national survey in
recent years to examine the supply of center-based programs and
licensed home-based care.
TEACHING OF COGNITIVE SKILLS IN HEAD START PROGRAMS
Question. Are real cognitive skills being taught in the Head Start
program?
Answer. Yes. Head Start has adopted the ``whole child'' view of
school readiness that was recommended by the Goal One Technical
Planning Group of the National Education Goals Panel. This view sees
school readiness as comprising five developmental domains that are
important to the child's readiness for school: physical well-being and
motor development, social and emotional development, approaches to
learning, language usage and emerging literacy, and cognition and
general knowledge. Each of these domains is represented in the Head
Start performance standards and measures and in the battery of
assessments in the FACES study, a nationally representative
longitudinal study of Head Start children that is being used to
determine the effectiveness of Head Start. The FACES study, initiated
in 1997, is entering its final phase in the spring of 2000. In the next
year, the study should yield important information about how Head Start
is succeeding in helping children achieve in the five designated
development domains addressed in the study, including the cognitive
domain.
HEAD START PROGRAM STAFF SALARIES
Question. What is the impact on the program of the low ``teacher''
salaries being paid to Head Start workers?
Answer. Head Start salaries have increased in recent years as the
Administration has continued to emphasize program quality. However, I
cannot speak specifically to the issue of the impact of the salaries of
Head Start workers, since I do not administer the program. I do know
that low salaries tend to discourage some highly qualified individuals
from entering the teaching profession at the elementary and secondary
education levels, and I assume that that is also true for the Head
Start program.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 9:30 a.m., Thursday, March
30, in room SD-124. At that time we will hear testimony from
the Honorable Dr. Ruthe L. Kirschstein, Acting Director,
National Institute of Health.
[Whereupon, at 11:25 a.m., Tuesday, February 29, the
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
March 30, 2000.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2001
----------
THURSDAY, MARCH 30, 2000
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:31 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, Stevens, Harkin, Kohl,
and Feinstein.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF DR. RUTH L. KIRSCHSTEIN, ACTING DIRECTOR
ACCOMPANIED BY:
DR. YVONNE T. MADDOX, ACTING DEPUTY DIRECTOR, NATIONAL
INSTITUTES OF HEALTH
DR. RICHARD D. KLAUSNER, DIRECTOR, NATIONAL CANCER INSTITUTE
DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD
INSTITUTE
DR. HAROLD SLAVKIN, DIRECTOR, NATIONAL INSTITUTE OF DENTAL AND
CRANIOFACIAL RESEARCH
DR. ALLEN M. SPIEGEL, DIRECTOR, NATIONAL INSTITUTE OF DIABETES
AND DIGESTIVE AND KIDNEY DISEASES
DR. GERALD D. FISCHBACH, DIRECTOR, NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND STROKE
DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES
DR. MARVIN CASSMAN, DIRECTOR, NATIONAL INSTITUTE OF GENERAL
MEDICAL SERVICES
DR. DUANE ALEXANDER, DIRECTOR, NATIONAL INSTITUTE OF CHILD
HEALTH AND HUMAN DEVELOPMENT
DR. CARL KUPFER, DIRECTOR, NATIONAL EYE INSTITUTE
DR. KENNETH OLDEN, DIRECTOR, NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES
DR. RICHARD J. HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
DR. STEPHEN I. KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS
AND MUSCULOSKELETAL AND SKIN DISEASES
DR. JAMES F. BATTEY, Jr., DIRECTOR, NATIONAL INSTITUTE ON
DEAFNESS AND OTHER COMMUNICATION DISORDERS
DR. STEVEN E. HYMAN, DIRECTOR, NATIONAL INSTITUTE OF MENTAL
HEALTH
RICHARD MILLSTEIN, DEPUTY DIRECTOR, NATIONAL INSTITUTE ON DRUG
ABUSE
DR. ENOCH GORDIS, DIRECTOR, NATIONAL INSTITUTE ON ALCOHOL ABUSE
AND ALCOHOLISM
DR. PATRICIA A. GRADY, DIRECTOR, NATIONAL INSTITUTE OF NURSING
RESEARCH
DR. FRANCIS S. COLLINS, DIRECTOR, NATIONAL HUMAN GENOME
RESEARCH INSTITUTE
DR. JUDITH L. VAITUKAITIS, DIRECTOR, NATIONAL CENTER FOR
RESEARCH RESOURCES
DR. STEPHEN E. STRAUS, DIRECTOR, NATIONAL CENTER FOR
COMPLEMENTARY AND ALTERNATIVE MEDICINE
DR. SHARON HRYNKOW, Ph.D., ACTING ASSOCIATE DIRECTOR FOR
PROGRAM COORDINATION, FOGARTY INTERNATIONAL CENTER
DR. DONALD A.B. LINDBERG, DIRECTOR, NATIONAL LIBRARY OF
MEDICINE
DR. NEAL NATHANSON, DIRECTOR, OFFICE OF AIDS RESEARCH
DENNIS P. WILLIAMS, DEPUTY ASSISTANT SECRETARY, BUDGET
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen.
The hour of 9:30 having arrived, we will proceed with the
hearing for the Appropriations Subcommittee on Labor, Health,
Human Services and Education.
Today our hearing will focus on the National Institutes of
Health, an extraordinary organization from very humble
beginnings in 1887 with a budget of $300. The NIH today is
comprised of 24 separate institutes and centers with 75
buildings of medical care on more than 300 acres in Bethesda,
MD. The budget is somewhat more than $300 today.
And Senator Harkin and I have taken the lead on major
increases, as you all know very well, with the cooperation of
Congressman Porter and Congressman Obey on the House side.
The achievements of NIH have been spectacular in my
opinion. And we have added funding at very substantial amounts
in recent years, frankly, over the--perhaps not quite over the
objections, but without the enthusiasm of as many members of
Congress as we would like to see.
Three years ago, we put up a resolution to add $1 billion
to NIH funding. And on a Senate vote, it was defeated 63 to 37.
But we found the money, Senator Harkin, Senator Taylor and I,
and the subcommittee, but candidly at the expense of other
programs, because it was not budgeted. And we ended up with
$907,000 million 3 years ago.
Having lost the resolution for $1 billion, we decided the
next year to try for $2 billion. And we got a few more votes,
but still substantially under 50. And we found $2 billion 2
years ago, as you all know.
Last year, we went again for $2 billion and got a few more
votes, but still less than 50. And Congressman Porter wanted to
trump the Senate's $2 billion with $300 million more. And when
we had the final roundup last year on the budget negotiations,
the leadership in both the House and the Senate did not like
it; we were taking too much money.
But with your good work and our persistence, we put it in
at $2.3 billion. And then there was the across-the-board cuts.
So it came down to $2.2 billion.
And this year we have put in a resolution for $2.7 billion.
And a question which I consistently get is: Is there too much
money being thrown at NIH? Is NIH able to utilize the money
which it has? And then there is always the issue of how well it
is being spent and what is being produced and what could be
produced with more. And as the funding has gone up, of course,
you have more applications for grants.
So we talk about those 100 doors out there, and we are only
opening 29 or 30 or 31 of them. But when the grants go up, or
the appropriations go up, rather, then your grants come in with
higher numbers.
But this subcommittee is dedicated to funding NIH
generously, because we think you are worth it. When you have a
Federal budget of $1.850 trillion, $18 billion for NIH is not
really, in my judgment, too much.
Well, having said that, I think we do not need a hearing.
We will just bring out the bank.
SUMMARY STATEMENT OF DR. RUTH L. KIRSHSTEIN
NIH has been blessed with very able directors. We miss Dr.
Harold Varmus and we miss Dr. Bernadine Healey. And we have an
outstanding acting director at the moment.
Dr. Ruth Kirschstein served as deputy director of NIH from
July of 1993 until the present time. From 1974 to 1993, she
served as the director of the National Institute of General
Medical Sciences, the first woman to hold such a position. She
came to NIH in 1956 as a medical officer in clinical pathology.
Dr. Kirschstein, that is the same year I started practicing
law. So you and I are experienced.
She received her bachelor's magna cum laude from Long
Island University and an M.D. from Tulane University School of
Medicine.
Welcome, Director Kirschstein. And the floor is yours.
Dr. Kirschstein. Mr. Chairman, I and my colleagues
appreciate all the wonderful things you have said about NIH
this morning. And we want to pledge to you that we will
continue to do excellent work.
I am honored to appear before the subcommittee to present
the President's budget for NIH for fiscal year 2001. As you
have already said, I have been at NIH for many years. And
although this is the first time I am testifying about the
overall NIH budget, it has been my privilege to appear before
this subcommittee annually for 19 years as the Director of the
National Institute of General Medical Sciences.
As you have also said, the increases for the NIH for fiscal
year 1999 and 2000, both nearly 15 percent, were dramatic and
unprecedented and have allowed us to undertake many new and
important programs.
And it has been the support of this subcommittee and the
subcommittee in the House that has made a substantial
difference in improving the public's health and well-being. And
so the funds requested for fiscal year 2001 will permit us to
continue our fiscal year 1999 and 2000 initiatives and allow us
to begin some new ones.
I would like to mention just two of the many, many advances
that occurred during the last year: First, the completion of
the first full sequence of a human chromosome, number 22. Its
genes have importance for immune system function and in the
development of congenital heart disease, schizophrenia, mental
retardation and several cancers.
And second, the identification of the gene that causes
salmonella bacteria to be deadly when ingested in food. And
this should open up the possibilities for the development of
new antibiotics, as well as vaccines.
In fiscal year 2001, we propose to emphasize first clinical
research on diabetes, osteoporosis, heart disease, neurological
diseases, cancer and a host of other serious diseases and
disasters, particularly those that have a disparate effect on
minority and underserved populations.
Second, the neurosciences will be emphasized; third,
genetic medicine; and fourth, bioengineering, bioimaging and
biomedical computing.
PREPARED STATEMENTS
Finally, Mr. Chairman, we will strive to ensure that the
NIH supports new initiatives that offer the most promise of
expanding knowledge and improving health and to ensure the
support of an appropriate number of new and young investigators
of the highest caliber.
I and my colleagues will be happy to respond to your
questions.
[The statements follows:]
Prepared Statement of Dr. Ruth L. Kirschstein
Mr. Chairman and Members of the Committee: I am Ruth Kirschstein,
the Acting Director of the National Institutes of Health (NIH). I am
honored to appear before the Subcommittee to present the President's
budget for NIH for fiscal year 2001. Although this is the first time I
have appeared before this Subcommittee to testify about the overall NIH
budget, it has been my privilege to appear annually for 19 years as
Director of the National Institute of General Medical Sciences. Mr.
Chairman, your support and the support of the members of the
Subcommittee, has made a substantial difference inimproving the
public's health and well-being.
Mr. Chairman, all of us, we at NIH, Members of Congress and the
citizens we serve, have similar expectations for medical research. We
want better ways of diagnosing and treating, and, in the long run,
preventing and curing disease. And we want the federal dollars invested
in medical research to result in the fulfillment of these expectations.
In the last century, the scientific community, both public and
private, worked in collaboration to cure or prevent once deadly
infectious diseases that are now given no more thought than the common
cold. I was fortunate enough to be at the forefront of the final
development of the polio vaccine, one of the truly monumental
achievements of the last century. There is not enough time today to
list the astounding medical breakthroughs that followed our increased
understanding of medical science. I will mention just a few: the
development of antibiotics and organ transplantation, life-extending
and life-saving cancer therapies, the identification of the AIDS virus
and the drugs to treat AIDS, and discoveries involving the chemicals in
the brain that are important in drug addiction and mental illness.
As we begin a new century, medical science stands on the threshold
of research advances that were once inconceivable. We have identified
the genes responsible for a large number of our normal functions and
the genetic abnormalities that cause many diseases, such as
Huntington's disease, cystic fibrosis, and certain forms of deafness.
You will hear much more from my colleagues.
In his budget plan for fiscal year 2001, the President is
requesting $18.8 billion for the NIH, an increase of $1 billion or 5.6
percent more than the fiscal year 2000 appropriation. By any measure,
the amounts we received in fiscal year 1999 and 2000, both nearly 15
percent increases, were dramatic and unprecedented. These generous
budgets have allowed us to undertake many new and important programs
and to improve conditions throughout the medical research enterprise.
The funds requested in fiscal year 2001 will permit us to continue our
fiscal year 1999 and 2000 initiatives and to begin new undertakings and
expand others under our Areas of Research Emphasis. I will say more
about these areas later.
We are pleased that the public, the Congress, and the
Administration place a high value on good health and understand the
role that medical research plays in improving the health of the
American public. These improvements result from new diagnostic
advances, more effective treatment options, better ways to prevent some
diseases, and ways to delay the onset or progression of other diseases
and disabilities.
We feel confident of public support for our research enterprise,
but are aware of our need to deliver to the public the two things it
most wants from the NIH:
--research advances, year after year, that improve the health of all
members of society;
--assurance that we spend the public's money wisely.
What the Public Wants from the NIH: Research Advances that Contribute
to the Health of Everyone
In the past year alone, we have seen dramatic advances that are
likely to have a direct, near-term effect on public health. The NIH
will continue to emphasize clinical research in fiscal year 2001
because it is critical in improving public health:
--Scientists completed the first sequence of a human chromosome, 22,
which has been implicated in immune system function, congenital
heart disease, schizophrenia, mental retardation, birth
defects, and several cancers, including leukemia. The 33.4
million nucleotides that make up chromosome 22 comprise the
longest continuous stretch of DNA ever deciphered. The
magnitude of this work is amplified by the insights it will
give us into many diseases.
--A clinical trial (carried out in cooaboration with scientists and
clinicians in Uganda) has demonstrated an affordable and
practical strategy for preventing transmission of the HIV virus
from mother to infant. A single oral dose of the antiretroviral
drug nevirapine given to an HIV-infected woman during labor and
another to her baby within three days of birth reduced the
transmission of virus by half compared with a similar short
course of AZT. This treatment might prevent some 300,000 to
400,000 newborns per year from becoming infected and eventually
developing AIDS at a cost which is affordable in developing
countries.
--Preeclampsia is a precursor to eclampsia, a potentially fatal
complication of pregnancy. It is characterized by high blood
pressure, excessive weight gain, and severe headaches.
Eclampsia leads to convulsions and causes a variety of birth
complications. Months before symptoms appeared, women with
preeclampsia were compounds, prostacyclin and thromboxane,
which control blood pressure. The discovery suggests new and
early treatments for this condition for which there is
currently no cure or treatment.
--An important gene that makes Salmonella a deadly bacterium was
identified. Without the gene, which encodes for the enzyme
called Dam, Salmonella bacteria not only did not kill the mice
into which they were injected, but also serve as a vaccine
against future infection by deadly Salmonella. Because Dam is
found in many other dangerous bacteria, this discovery opens
possibilities for a whole new generation of antibiotics and
vaccines.
What the Public Wants from the NIH: Assurance that its Funding is Well
Spent
It is clear that the public wants a fuller understanding of the
NIH's funding allocations and how it sets priorities--that is, an
assurance that the taxpayers' dollars are well spent. We believe, in
fact, that the more the public knows about our processes the more it
will support both what we do and how we do it. I want to touch on six
principles relevant to establishing priorities:
--An obligation to respond to public health needs, judged variously
by the incidence, severity, and cost of specific disorders.
However, calculations cannot be correlated with research
spending in a simple manner.
--A responsibility to capitalize on previous discoveries and to eize
the scientific opportunities that offer the best prospects for
obtaining new knowledge and better health. Not all problems are
equally approachable, regardless of their importance to public
health. Some only yield to a new technology or insight. We
must, however, create environments that stimulate new ideas
about difficult problems.
--A need to maintain a diverse portfolio on a wide range of diseases.
We cannot always know in advance which discovery will be
applicable to which disease.
--An obligation to insure first-rate scientific workforces and
research facilities.
--A need to seek advice from many sources, including the public.
--And last, but truly foremost in our minds, a commitment to support
scientific work of the highest caliber.
Peer review is the cornerstone of our efforts to fund the best
science. To identify research worthy of funding, about 40,000 grant
applications are peer reviewed at the NIH each year. Of these,
approximately 75 percent are evaluated within the NIH Center for
Scientific Review (CSR). The NIH is ensuring that CSR has sufficient
resources so that its review will recognize, and capitalize on, the
opportunities created by the diverse successes of the medical research
enterprise, will anticipate emerging fields of research, and
accommodate to the rapid pace of scientific change.
In 1998, the Congress asked the Institute of Medicine (IOM) to
review the NIH's process for setting priorities. While supporting our
principles, the IOM made some useful suggestions about ensuring that
our programs are responsive to the public. Over the past year, NIH has
responded by appointing a Council of Public Representatives (COPR). The
COPR improves our accountability by bringing public views to the NIH,
by looking at how the NIH carries out different aspects of its mission,
and by conferring on trans-NIH issues. The COPR will be involved in
many aspects of NIH programs and policies.
Following another suggestion in the IOM report, this past year the
NIH Director required each Institute and Center to produce a strategic
plan of research needs and opportunities over two to five years. The
plans were developed with input from a wide range of NIH constituents,
including patient and other health advocates, scientists, health-care
providers, the Congress, the Administration, NIH staff, and other
representatives of the public. These strategic plans will be available
in the near future and should improve public understanding of the
challenges all components of the NIH are facing.
This past year, for the first time, the NIH held a Budget Retreat
in June to help develop its presentation of priorities and Areas of
Research Emphasis for the President's 2001 budget. The meeting involved
ten external advisors, five from COPR and five from the Advisory
Committee to the Director (ACD), and created enthusiasm for new areas
for collaboration across institutes.
In another major effort to bring public views to bear upon the
NIH's programs, priorities, and activities, 26 individuals from outside
the agency--scientists, physicians, other health-care providers,
patients, and representatives of the ACD and the COPR--met in October
to evaluate the scientific quality and relevance of the outcomes of NIH
research, a requirement of the Government Performance and Results Act.
A report of their assessment has been sent to the Congress as part of
the President's budget.
Realizing the Potential of the fiscal year 2001 Budget Request
Generous increases in the last two budget cycles have allowed the
NIH to begin many new programs. The funds requested for fiscal year
2001 will advance these programs and, with sound management, allow us
to begin new ones. To ensure that NIH can support new initiatives that
offer the most promise of expanding knowledge and improving health, and
to ensure our ability to support a healthy number of new and young
investigators, we will limit growth in commitments and in the size of
awards to a two percent average increase for new and continuing grant
awards. In addition to initiatives on mental health, cancer, and
diabetes, new activities include:
Clinical Research.--To take full advantage of rapid research
advances in the last five years, which have provided abundant new
therapies to study, the NIH will begin a series of programs to expand
clinical research. Career development programs will continue to improve
the number and quality of investigators. We will start new pilot and
early-phase clinical trials thereby speeding the testing of new
therapies. We will develop new, and expand older, networks for multi-
center studies of pediatric cardiovascular disease, diabetes, digestive
diseases, and treatment for drug abuse. We will establish new multi-
center clinical trials to evaluate complementary and alternative
medical practices for insomnia, pain relief, and liver diseases.
Moreover, the public will have greater access to new information on an
expanded national clinical trials database (ClinicalTrials.gov) to be
launched soon . It will carry information on the many clinical trials
funded by the NIH, by other federal agencies, and by industry.
Health Disparities.--The NIH has a central role to play in
eliminating persistent, even increasing, health disparities through
medical research, research training, and dissemination of
scientifically sound medical information. In fiscal year 2001, the NIH
will continue to invest in this area, allocating $20 million to
establish a new Coordinating Center for Research on Health Disparities
within the Office of the NIH Director. A new trans-NIH Working Group
will develop a strategic plan to eliminate or reduce health disparities
among different segments of the American population. The plan, will
include goals, timetables, and mechanisms for tracking budgets and
accomplishments.
Genetic Medicine.--Last November, the Human Genome project finished
sequencing one billion of the estimated three billion base pairs of
human DNA and deposited them in GenBank, NIH's public database, thus
putting us on schedule to have a working draft of the full human genome
by this spring. Scientists can use this information to find the genes
involved, e.g., in heart diseases, cancer, epilepsy, Alzheimer's, and
psychiatric disorders. Companion activities, like developing genomic
resources for organisms such as mice, rats, and fruit flies, will help
speed the arrival of more precise medical interventions. We are rapidly
moving to a time when diagnosis, treatment and even prevention will
depend on a precise understanding of the genetic makeup of an
individual.
Neurosciences.--This is a particularly exciting time for expansion
of research in fields of neuroscience, such as neurogenetics and
imaging. To foster collaboration and sharing of ideas among the many
Institutes which support intramural research in this area, we are
requesting funds for construction of a facility for the new National
Neuroscience Research Center to house outstanding trans-NIH
neuroscience research programs. A total of $73 million is requested
over two years, with $47 advance for fiscal year 2002.
Other Sciences, Including Biomedical Computing.--Many medical
advances build on the knowledge and technology of other scientific
disciplines. To exploit our new understanding of biological processes,
we need new teams of diverse and skilled researchers to overcome
complex technological and research problems. In fiscal year 2001, NIH
will establish an Office of Bioengineering and Bioimaging to help the
Institutes and Centers set priorities in these areas of science and to
enhance collaboration with other agencies.
Based on a report by outside experts, NIH has developed the
Biomedical Information Science and Technology Initiative to work toward
an intellectual fusion of biomedicine and information technology. In
fiscal year 2001, the NIH plans to provide the infrastructure to train
the next generation of interdisciplinary scientists, to develop new
means for storing, managing, and accessing vast data collections, and
to enhance basic research in biomedical computing.
Mr. Chairman, that concludes my opening statement. I will be glad
to respond to any questions.
______
Prepared Statement of Dr. Yvonne T. Maddox
Mr. Chairman, Members of the Committee: I am pleased to be here
today to discuss the fiscal year 2001 budget request for the Office of
the Director (OD). The OD provides leadership and coordination for the
research activities of NIH, both extramural and intramural. The OD also
is responsible for a number of special programs and for management of
centralized support services essential to the operation of the entire
NIH.
The President has proposed that the OD receive $262.5 million in
fiscal year 2001, an increase of $25.2 million over the comparable
fiscal year 2000 appropriation. Including the estimated allocation for
AIDS in both years, total support proposed for the OD is $309.0
million, an increase of $27.0 million over the fiscal year 2000
appropriation. Funds for OD efforts in AIDS research are included
within the Office of AIDS Research budget request.
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.
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 requests for each of these trans-NIH
offices in greater detail.
HEALTH DISPARITIES, THE OFFICE OF RESEARCH ON MINORITY HEALTH, AND THE
MINORITY HEALTH INITIATIVE
The Secretary, through the Department's Healthy People 2010
initiative, has made a major commitment to reduce health disparities
affecting minorities and other medically underserved socioeconomic
groups of Americans. To address these inequities, NIH has established
health disparities research as a budget priority and an area of
emphasis. This year, we have established the Office of Research on
Minority Health (ORMH) as the Coordinating Center for developing a
trans-NIH Strategic Plan for Health Disparities that will integrate the
various research activities of the ICs toward the goal of significantly
reducing health disparities. Additionally, in fiscal year 2001, NIH is
requesting $20 million in new funding and related legislative authority
for the Coordinating Center to award grants for minority health
research under exceptional circumstances, when the Institutes and
Centers do not fund such research that has been identified as a
priority.
The Minority Health Initiative (MHI) is a comprehensive, trans-NIH
program with a focus on developing and testing ways to reduce the
disproportionate burden of disease among minority populations and on
developing strategies to promote positive health behaviors across the
life span. The MHI specifically targets the elimination of health
disparities experienced by racial and ethnic minority populations in
four key areas: infant mortality; breast, cervical, and prostate cancer
screening and management; cardiovascular disease; and complications
arising from diabetes. The MHI will also support the Minority
Institution Cancer Center Partnerships designed to create collaborative
relationships between institutions that primarily serve minorities and
the NCI-designated cancer centers to conduct research, training,
education, and outreach activities that focus on the disproportionate
incidence of cancer in ethnic minority populations.
THE OFFICE OF DISEASE PREVENTION
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 2001, the Office of Dietary Supplements (ODS) will
continue to develop the Dietary Supplements Research Centers
Initiative. Currently, three such Centers are being funded in
conjunction with the National Center for Complementary and Alternative
Medicine (NCCAM), the National Institute of General Medical Sciences
(NIGMS), the National Institute of Environmental Health Sciences
(NIEHS), and the Office of Research on Women's Health (ORWH). The long-
term goal of the Initiative is to fund eight Centers, four on
botanicals and four on other categories of dietary supplements. The ODS
will continue to support investigator-initiated research through the
Research Enhancement Awards Program (REAP), and through collaborations
with other Institutes and Centers at NIH.
In continuing efforts to inform the public about the benefits and
risks of dietary supplements, the ODS plans to release a new computer
information database on dietary supplements, and will offer, with the
NIH Clinical Center, the first collection of public-oriented
information pages (fact sheets) on specific dietary supplements, in
print and through Internet access. ODS will follow with a series of
fact sheets for botanical and herbal supplements to be released in
collaboration with NCCAM.
Another component of ODP, the Office of Rare Diseases (ORD),
supports research activities on rare diseases and conditions, develops
and disseminates information to health care providers and patient
support groups, and forges links among investigators with ongoing
research activities in this area. The ORD continues to support
workshops and symposia to stimulate research and to identify research
opportunities related to rare diseases. The effectiveness of these
workshops as a valid mechanism to stimulate research on rare diseases
and conditions is now being evaluated.
THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH
As NIH continues its efforts to improve health outcomes, there is
increasing awareness that many of our most serious health concerns are
related to individual behaviors and social context. In fact, four
health-damaging behaviors-tobacco use, physical inactivity, dietary
patterns, and alcohol abuse--are responsible for nearly 40 percent of
the annual deaths in our Nation. The Office of Behavioral and Social
Sciences Research (OBSSR) works to integrate a psychological and social
perspective across all research programs at NIH and to increase the
support for behavioral and social science research and training.
One strategy that OBSSR uses to increase support for behavioral and
social sciences research is the development of broad trans-NIH
initiatives that address issues relevant to many Institutes and
Centers. In order to gain a better understanding of the obstacles and
facilitators to engaging in healthy behaviors, OBSSR and 16 other NIH
Offices, Institutes and Centers recently specifically solicited grant
proposals for research on disease prevention through behavior change
which focused on tobacco use, insufficient exercise, poor diet and
alcohol abuse. The OBSSR, with several ICs, also supports centers to
investigate aspects of the interactions between mind and body in health
and disease. In addition, OBSSR has joined with 12 Institutes to
solicit grant applications addressing the problem of inadequate
adherence to prescribed medications and therapies.
OBSSR has long been concerned about the issue of violence in our
society as a public health problem, and has worked to establish a
trans-NIH Expert Panel on Youth Violence. This panel found that more
research on youth violence interventions was needed. Subsequently,
OBSSR developed a trans-NIH grant solicitation for interventions to
prevent and reduce youth violence.
THE OFFICE OF RESEARCH ON WOMEN'S HEALTH
The Office of Research on Women's Health (ORWH) is the focal point
for women's health research at NIH and strives to ensure that research
supported by NIH addresses the health concerns of women, that women are
appropriately included as subjects in research protocols and clinical
trials, and that women are encouraged to pursue careers in medical
research. The science-based activities of ORWH are determined by the
Agenda for Research on Women's Health for the 21st Century, an agenda
developed following public hearings and scientific workshops involving
some 1,500 representatives dedicated to improving the health of women.
In fiscal year 2001, the ORWH will pursue a number of recommendations
within this agenda including research on the effects on women of
therapeutic agents, studies to develop gender-based treatments for
kidney disease, studies that address prevention and elimination of lung
cancer in women. In addition, the ORWH will support career development
programs that encourage the pursuit of interdisciplinary research
careers relevant to women's health and encourage patient-oriented or
population-based clinical research careers. Finally, ORWH will continue
to monitor compliance with established policies for the inclusion of
women and minorities in clinical research.
OTHER OD ACTIVITIES
The OD also supports a number of additional NIH programs that
promote research and enhance research career development.
The Office of Extramural Research (OER) coordinates the Academic
Research Enhancement Award (AREA) program to provide grants to
institutions that award degrees in health sciences but are not major
recipients of NIH grant funds. These awards enable college students to
participate in research projects and encourage them to pursue careers
in medical research. OER also sponsors the Extramural Associates
Research Development Award (EARDA) program to provide competitively
awarded grants to institutions that have a significant enrollment of
underrepresented minority students who, with their faculty, participate
in medical research programs. The grants are designed to provide
faculty at these institutions with skills needed to become more
competitive in obtaining Federally sponsored research funds.
In May of fiscal year 2000, the Office of Bioengineering/Bioimaging
(OBB) will be established within the OER to advance the fields of
bioengineering and bioimaging. OBB will foster new collaborations among
the biomedical and engineering/physical sciences with the goals of
developing innovative technologies and novel products for improving
human health.
The OBB will develop and coordinate programs for transdisciplinary
training and career development, sponsor major symposia and smaller
meetings aimed at enhancing communication among the biomedical and
engineering/physical science communities, and focus attention on
research in bioengineering and bioimaging. The OBB will also coordinate
the Bioengineering Consortium (BECON), which consists of senior
bioengineering representatives from all NIH research institutes and
centers and other federal agencies.
The OER request will also provide funds for the new Extramural
Clinical Research Loan Repayment Program. This program is designed to
counter economic barriers to the pursuit of clinical research careers
and to provide an incentive to engage in this area of research. The
program will award contracts to repay the educational costs of health
professionals conducting clinical research in extramural institutions
who agree to enter into two-year service contracts to pursue clinical
research.
The NIH, through the Office of Intramural Research (OIR), maintains
intramural loan repayment and scholarship programs as important
instruments for recruiting high quality candidates in basic and
clinical research positions. The request contains funds for the NIH
Clinical Research Loan Repayment Program and the Undergraduate
Scholarship Program, both for individuals from disadvantaged
backgrounds, and for the General Research Loan Repayment Program. Each
program provides for the payment of educational costs in return for
specific commitments of service in NIH's intramural research
facilities.
The Office of Science Policy (OSP) has a role in addressing science
policy issues on behalf of NIH and in coordinating several science
education activities. Specifically, the OSP has developed, with the
Institutes and Centers, curriculum supplements to complement existing
science curricula in grades K-12 that benefit both students and
teachers and encourage students to consider careers in research.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
I will be pleased to answer questions.
______
Prepared Statement of Dr. Richard D. Klausner
Mr. Chairman and Members of the Committee: I am pleased to appear
before you for the fifth time to describe our progress in and hopes for
the programs of the National Cancer Institute (NCI). I would also like
to recognize with personal sadness that this will be the last hearing
where I will have the pleasure of appearing before our remarkable
Chairman, Mr. Porter.
THE BURDEN OF CANCER
Each year, I have begun this testimony by reporting one critical
measure of the cancer burden, the annual statistics of cancer
incidence, survival rates and mortality. We have recently begun to
review the latest numbers and the decrease in overall cancer mortality
rates first observed in the early 1990s are accelerating between 1995
and 1997, the latest year for which we have data. Drops continue to be
seen for the four major cancer sites of lung, colorectal, breast and
prostate. Cancer sites where mortality rates are still increasing
include liver and non-Hodgkin's lymphoma. Overall, mortality rate drops
are seen in both the black and white population. Remarkably, the
magnitude of these drops are such that, for the first time, between
1996 and 1997, the total number of cancer deaths did not rise, despite
a growing and aging population.
As this Subcommittee has discussed before, the burden of cancer is
not equally experienced across our population. Monitoring rates and
trends over time, by geography, by gender, age and racial and ethnic
groups has been a priority for the NCI. We are particularly concerned
about the disproportionate burden of cancer among the poor, the
medically underserved and among certain ethnic minorities. In response
to our planning processes, we are in the midst of a number of
expansions in our programs aimed at the ability to assess, explain and
affect the unequal burden of cancer. These expanded and new initiatives
address the important message of last year's Institute of Medicine
(IOM) report on the unequal burden of cancer.
We are in the process of expanding the Surveillance Epidemiology
and End Results (SEER) program (our cancer surveillance program) to
enhance coverage of rural whites and blacks, non-Mexican Hispanics and
Native Americans. We are completing a new Memorandum of Understanding
(MOU) with the Centers for Disease Control and Prevention (CDC) to
formalize collaboration and integration of the NCI's surveillance and
surveillance research programs with the CDC's National Program of
Cancer Registries. This will allow a strategic integration of the NCI's
more intensive surveillance and research system with the CDC-funded
state registry systems, to help develop data standards and tools for
pooling data.
In fiscal year 2000, we will begin to fund a new research program
to create Special Population Networks (SPNs) for cancer control and
research. These new consortia will be based within various communities
serving different segments of our diverse society in order to establish
cancer control and research infrastructures to work within and to serve
these communities. To support the activities of these SPNs, we are
establishing a cancer control academy at the NCI for training and will
link these community-based research networks to the full range of
information and communication resources of the NCI. These SPNs, we
hope, will provide the basis for a new national platform for cancer
research to address the distinct cancer burdens of special populations.
We are setting aside $50-60 million over five years to fund about 14
SPNs, the largest program of its kind we have ever funded.
This year, in collaboration with the NIH Office of Research on
Minority Health, we began funding five research partnerships between
NCI-designated cancer centers and minority institutions to create
active and successful research programs linked to our most successful
cancer research institutions. We plan to release a new Request for
Applications (RFA) to sustain and enhance these new enterprises. A more
complete description of our activities in this crucial area can be
found at the NCI Office of Special Populations Research Web site
(www.ospr.nci.nih.gov).
Monitoring cancer incidence and mortality trends can help us
formulate questions about the distribution of cancer control and care,
as well as about possible causes of cancer. This year, the NCI
released, for the second time in its history, 25-year cancer mortality
maps. These cover all 3,100 United States counties and state economic
areas, for 40 cancer sites, by gender and race. These maps are
available on the NCI Web site in a user-friendly and dynamic format.
They do not tell us causes of cancer or indeed whether a geographic
pattern reveals either a localized environmental factor, a behavioral
pattern or a socio-economic pattern. But, by providing the starting
point for addressing these issues, these maps are crucial resources.
The NCI will release a Request for Application (RFA) to support two
types of studies linked to these maps: epidemiologic research to search
for explanations for geographic and temporal cancer patterns, and
methodologic research to develop Geographic Information Systems (GIS)
for evaluating environmental associations with cancer. These maps are
one part of NCI's extensive ($472 million in fiscal year 1999) program
in establishing environmental (exogenous) causes of cancer.
PROGRESS IN BASIC RESEARCH
Progress in our understanding of the biology of cancer continues at
an astonishing pace. Let me highlight two examples. For decades,
scientists have tried to define the minimum number of molecular changes
and the number and nature of molecular pathways that must be perturbed
to turn a normal cell into a cancer cell. This year, NCI-funded
investigators identified that alterations of only three genes and four
molecular pathways are sufficient to transform a normal human cell to
one capable of producing a tumor. These identified pathways are already
providing long-sought targets for new therapeutics. Identifying the
specific molecular pathways that define each type of human cancer has
allowed us to begin to replicate these changes in the genes of mice. As
predicted, these mice develop cancer and for the first time, we can
accurately mimic human cancer in the mouse. This is allowing us to
finally test whether molecular changes associated with human cancer and
its development are actually the causes of the progression and behavior
of cancer. To accelerate the output of these breakthroughs and to use
them to discover and test ways of preventing and curing cancer, we have
established the Mouse Models of Human Cancers Consortium, an
international collaboration of over 70 institutions. This consortium
will support the development and validation of mouse models for human
cancer. It is a new research structure that will enable the sharing of
reagents and expertise, the development and dissemination of new
technologies, the establishment of standards and prioritization of
research questions. We hope to expand the activities of the MMHCC to
support the development and utilization of these important new cancer
research tools.
NEW APPROACHES TO DETECTION AND DIAGNOSIS
The knowledge that cancer cells develop by changing their molecular
profile has set the stage for a new and systematic approach to both
early detection and accurate diagnosis. Three years ago, the NCI set
out to establish a full index of all the genes that are altered in each
type of cancer. This project, called the Cancer Genome Anatomy Project
or CGAP, has been extremely successful, identifying tags for the vast
majority of human genes, annotating what types of cells and cancers
express those genes, developing catalogues of chromosomal changes in
cancer and discovering common genetic variations that will help to
explain why individuals are different in their risk of getting cancer,
their sensitivity to diet and the environment and their response to
therapy. CGAP has become one of the most widely used sources of
information and reagents in the research world (www.ncbi.nlm.nih.gov/
ncicgap/).
As we approach a complete list of all of the molecular tags
associated with each cancer and its development, we can systematically
search for ``markers'' for the early detection of cancer. To utilize
the wealth of discovery coming from CGAP in the development of cancer
markers, we have created a new national research infrastructure, called
the Early Detection Research Network (EDRN). The EDRN is a novel and
complex research structure established to discover, develop and
validate markers for the early detection of cancer. Researchers from
multiple institutions will work together to assure that potential
markers are prioritized, developed into reliable and standardized
assays and validated on readily available and well characterized
clinical materials. Four components of the EDRN are now funded: (1)
Marker discovery laboratories (18 institutions); (2) Marker development
laboratories (2 institutions); (3) Clinical and Epidemiology Centers (8
institutions); and (4) a data and statistical center. In its first
year, the EDRN will focus on markers for breast, prostate, ovarian,
lung and GI cancers.
Systematic gene discovery through CGAP and other projects is about
to profoundly change our approach to the classification and therefore
the accurate diagnosis of cancer. To do this has required the
development and dissemination of new technologies to read the complete
molecular profiles of cancer. To enable this, the NCI funded the
establishment of 24 ``microarray'' centers across the country. Next,
the Institute announced a new funding initiative called the Director's
Challenge whose goal is to identify new molecular classification
schemes for cancer to replace the purely histologic schemes of the last
century. The initial funding established 10 consortia involving 24
institutions addressing breast, prostate, ovarian, and colorectal
cancers as well as lymphomas and leukemias. Already, results from these
groups are revealing new types and subtypes of cancer that appear to
predict which patients will respond to particular therapies. This year,
we hope to expand this program to more types of cancer and to define
the clinical implications of these new classes of cancers to help
predict prognosis and guide the choice of therapy.
IMAGING CANCER
Four years ago, the NCI identified imaging as one of its
extraordinary opportunities for investment. We have developed new
funding mechanisms for exploratory, innovative grants (almost 150
grants received), the establishment of six small animal imaging
centers, and the establishment of a national clinical trials network to
rapidly evaluate the clinical utility of new imaging approaches. This
network, called the American College of Radiology Imaging Network
(ACRIN) has a number of clinical trials in preparation including a
comparison of Magnetic Resonance (MR) and Computed Tomography (CT) in
gynecologic malignancies, the use of Positron Emission Tomography (PET)
to follow response to chemotherapy, the value of spiral CT for lung
cancer screening, comparative studies of virtual colonoscopy and of
digital mammography. We are also funding the development of centers to
foster the new field of functional imaging, whereby we can detect not
only the presence of a tumor but query its molecular characteristics
and its behavior. This year, we will be able to fund 2-3 full multi-
disciplinary In Vivo Cell and Molecular Imaging Centers (ICMICs). In
addition, 27 institutions have applied to receive planning grants to
develop such centers. This year, we created the Unconventional
Innovations Program (UIP) aimed at developing truly novel detection and
imaging systems by bringing revolutionary technologies of molecular
sensing, nanoscale devices and microexplorers to enable the remote
sensing of cancer. We have funded six consortia of investigators to be
part of this program and hope to add more members in response to a
second release of this Broad Agency Announcement. Over the past year,
our investment in imaging research and technology has increased 30
percent.
Finally this year, the NCI organized a unique forum to bring
together academics, industry (through the National Electrical
Manufacturer's Association), the Food and Drug Administration (FDA) and
Health Care Financing Administration (HCFA) to coordinate practices
relevant to the development, testing and adoption of new imaging
modalities and applications. This collaborative enterprise will be a
standing forum to facilitate communication and progress in this
critical area.
MOLECULAR TARGETS--NEW APPROACHES TO PREVENTION & TREATMENT
For the past three years, the NCI has been redirecting its drug
discovery program to one based on the success of basic research in
identifying the precise molecular targets implicated in the development
(prevention targets) and behavior/survival (therapeutic targets) of
cancer. The recent encouraging results of Herceptin for the treatment
of advanced breast cancer, Rituximab for the treatment of non-Hodgkin's
lymphoma, STI 571 for the treatment of leukemia, tamoxifen for reducing
the risk of breast cancer and a growing list of others, all point to
the future face of molecularly targeted therapeutics and preventives.
We have funded four new centers to develop new libraries of chemical
diversity and to screen for promising molecular targets, and this year,
we will fund new Centers of Excellence for drug development, each of
which will focus on specific cancer pathways to speed the discovery of
useful targets.
Last year, we initiated a novel program called RAID (Rapid Access
to Intervention Development) that evaluates promising drug candidates
in the laboratories of academic investigators and, via peer review,
manages the movement of these candidate drugs from the lab to the point
of clinical trial. To date, 32 novel agents have entered the RAID
pipeline and in one year 4 have reached or are ready for clinical
trials. We will expand this successful program in the coming year.
CLINICAL TRIALS--A CORNERSTONE OF PROGRESS FOR PATIENTS
Last year, the NCI supported over 1500 clinical trials in
prevention and treatment, covering virtually all human cancers and
asking a wide variety of clinical questions. We initiated the formal
restructuring of our national clinical trials system, as described to
the Subcommittee last year. This restructuring is aimed at improving
the quality of scientific questions asked, increasing the speed and
efficiency and decreasing the administrative burdens of participating
in clinical trials. Furthermore, it aims to assure that all patients
and all participating physicians have access to the full menu of
available clinical trials. This year, we continued the development and
deployment of a standard informatics system, funded a central Clinical
Trials Support Unit to serve the entire national clinical trials system
and began disease-specific state-of-the-science meetings to develop
prioritized clinical trials questions and opportunities. This past
year, 20,000 new patients were enrolled in NCI-sponsored treatment
trials. Over the past three fiscal years, our investment in our
national clinical trials program has increased almost 43 percent.
Clinical trials are complicated enterprises, and streamlining and
improving their function while maintaining the highest standards of
rigor, care and protection of human subjects requires attention to many
different facets of the initiation, review, approval, funding,
oversight and management of trials. This year, we have continued to
expand the use of simplified and uniform informed consent documents and
in the spring, in collaboration with the Office for Protection from
Research Risks (OPRR), we will begin an important pilot project to test
the feasibility and performance of a central Institutional Review Board
(IRB) for multi-institutional trials.
This year, we unveiled a new, user-friendly clinical trials
information system to enable patients and physicians to readily access
information about all NCI-sponsored trials (www.cancernet.nci.nih.gov).
We continue to work with the FDA and industry to expand this database
to include industry and other sponsored trials.
Each year, clinical trials results help shape the course of
clinical practice and set the stage for new questions that need to be
addressed. This year, we saw the first, long-awaited results on the
value of high dose chemotherapy with peripheral stem cell or bone
marrow rescue for women with advanced breast cancer. These results did
not support the significant and hoped-for benefits that this approach
demonstrated in earlier, non-randomized clinical trials. These results
underscored the crucial role that such clinical trials play in the type
of evidence-based medicine to which we all aspire. In the past two
years, the results of clinical trials have set new standards for
increasing the effectiveness and reducing the toxicity of regimens for
childhood cancers, leukemia, myeloma, breast cancer, ductal carcinoma
in situ (DCIS), cervical cancer, head and neck cancer, lymphoma,
colorectal cancer, prostate cancer and others.
QUALITY CANCER CARE--A RESEARCH AGENDA
One of the themes of NCI activities is to address gaps--gaps
between what we need to know and our current state of knowledge, gaps
between the burden of cancer across different segments of our
population, and gaps between scientific discovery and medical
breakthroughs. One of the most important gaps is between evidence-based
best practice and actual practice. It is this last gap that we intend
to address via a new major initiative called the Quality Cancer Care
Committee (QCCC). This initiative was formulated in response to a
recent report of the National Cancer Policy Board (NCPB) called
``Ensuring Quality Cancer Care.'' The NCPB was established at my
request as part of the Institute of Medicine (IOM) of the National
Academy of Sciences. Its purpose is to provide a forum of independent
and broad-based expertise to advise the Nation on cancer-related policy
issues. The QCCC will be a trans-agency initiative led by the NCI to
develop a comprehensive research infrastructure to address the issues
of quality cancer care across the cancer continuum from prevention to
treatment to survivorship and end-of-life care; and to provide a
mechanism whereby the health delivery and reimbursement activities of
DHHS, especially HCFA, are informed by a discussion of evidence and
through direct interaction with the cancer research agenda of the
various research agencies of the Department. The research agenda of the
QCCC will focus in four areas: 1) developing measures of cancer
outcomes; 2) strengthening the methodologic and empiric base for
quality assessment; 3) strengthening the national clinical trials
infrastructure; and 4) improving the quality of cancer communications.
I am pleased to present the President's non-AIDS budget request for
NCI for fiscal year 2001, a sum of $3.25 billion which reflects an
increase of $183 million over the comparable fiscal year 2000
appropriation. Including the estimated allocation for AIDS, total
support requested for NCI is $3.505 billion an increase of $193 million
over the fiscal year 2000 appropriation. Funds for the NCI efforts in
AIDS research are included within the Office of AIDS Research budget
request. With this, we can sustain the many new and productive
programs, some of which I have tried to illustrate in this testimony.
NIH budget request includes the performance information required by
the Government Performance and Results Act (GPRA) of 1993. Prominent in
the performance data is NIH's first performance report which compares
our fiscal year 1999 results to the goals in our fiscal year 1999
performance plan. As our performance measures mature and performance
trends emerge, the GPRA data will serve as indicators to support the
identification of strategies and objectives to continuously improve
programs across the NIH and the Department.
______
Prepared Statement of Dr. Claude Lenfant
Mr. Chairman and Members of the Committee: I am pleased to address
this Committee, once again, on behalf of the National Heart, Lung, and
Blood Institute (NHLBI). During the latter half of the Twentieth
Century, tremendous progress was made in improving the health of the
American public. Research supported by the NHLBI was instrumental in
enabling us to diminish, halt, and eventually reverse the epidemic of
deaths from two major chronic diseases--coronary heart disease and
stroke. Vital statistics indicate that, since its peak in 1963, the
death rate for coronary disease has fallen 60 percent and the rate for
stroke fell 66 percent during that time period. This has been a
tremendous achievement.
Nonetheless, these two diseases have retained their ranking as the
first and third most common causes of death in the United States and,
during the past decade, mortality has not fallen as rapidly as it once
did. We have, in a sense, weeded out many of the ``easy'' cases; those
that remain are more complex and demand far more sophisticated
solutions. Our challenge is twofold: first, to make maximal use of the
new technologies that are rapidly becoming available and, second, to
ensure that ``real world'' health practices reflect a rapid and
thorough utilization of the knowledge that we have acquired. Both are
essentially matters of closing the gap between what can be done and
what is being done.
PROGRAMS FOR GENOMIC ANALYSIS
The generous increases in funding that the NIH has received in the
past several years have provided extraordinary opportunities to invest
in cutting-edge research programs to capitalize on the new
technologies. As you know, the Human Genome Project is on the verge of
producing its draft ``blueprint'' for the entire genetic make-up of
humankind, which will be invaluable to the research community. In
anticipation of this tremendous resource of data and technologies, the
NHLBI is establishing Programs for Genomic Analysis in cardiovascular,
lung, and blood diseases and sleep disorders. This ambitious new
undertaking will call upon the expertise and collaboration of
scientists from a wide variety of disciplines--and often from diverse
geographical areas--to identity relevant genes, understand their
function, and test hypotheses about the causes and treatments of
disease. An essential requirement of the Programs is that the
information and reagents generated will be made immediately and freely
available to the research community, a practice that will enable a
broad range of investigators to exploit the promising opportunities
provided by this fast-moving field. This initiative has generated
tremendous enthusiasm within the research community, and it promises to
advance our knowledge of health and diseases in ways that could not
have been dreamed of a decade ago.
PROGRAMS OF EXCELLENCE IN GENE THERAPY
Despite the recent troubling publicity about gene therapy, the
NHLBI remains committed to pursuing this approach because of its
potential usefulness for many intractable diseases. We just have to do
it right. Accordingly, we are establishing comprehensive Programs of
Excellence in Gene Therapy that will focus on rapid translation of
findings from basic research into pilot studies in human volunteers,
with appropriate attention to safeguarding the welfare of the patients.
A major goal of this initiative will be to provide shared access to
specialized services such as preclinical toxicology testing and the
development of ``vectors'' to ferry therapeutic genes to their target
tissues. The promise of gene therapy to cure hemophilia, cystic
fibrosis, sickle cell disease, and other devastating diseases has long
been recognized, but the path to its fulfillment has been fraught with
many difficulties. We believe that this coordinated approach will make
it a reality.
USING MRI TO DIAGNOSE HEART ATTACK
A pilot program at Suburban Hospital in Bethesda is testing a new
approach to diagnosing heart attack patients who may be candidates for
thrombolytic therapy. The value of this clot-dissolving treatment in
limiting damage from a heart attack has been well established for some
time. However, its effectiveness is highly dependent on the promptness
with which it is administered, and many patients have not had the
opportunity to benefit from this approach. We have been working through
our National Heart Attack Alert Program to reduce delays in treatment,
and data from the National Registry of Myocardial Infarction indicate
that the time between arrival at the emergency room and administration
of thrombolytic therapy has been reduced from 60 minutes to about 35
minutes in patients for whom an EKG is diagnostic of a heart attack.
However, for many patients, diagnosis currently requires measurement of
enzymes that appear in the bloodstream only hours after the heart
attack has occurred--too late for effective thrombolysis. The
experimental program at Suburban Hospital is using MRI (magnetic
resonance imaging) technology, which can provide a diagnosis in about
35 minutes. In light of recent evidence that thrombolytic therapy may
also benefit patients who experience a thrombotic stroke, we have also
teamed up with the National Institute of Neurological Disorders and
Stroke to use MRI in evaluating patients who come to the emergency room
with stroke symptoms. We have every confidence that this program will
form the basis for an entirely new approach to delivering prompt
treatment to patients who are likely to benefit from it.
CLINICAL RESEARCH NETWORKS
During the past few years, the NHLBI has been an innovator in
establishing clinical research networks to close the gap between what
is known about the causes and mechanisms of disease and the tools that
are available to treat them. These networks maintain a core structure
of clinical centers and a data coordinating center that collaborate in
conducting high-quality, systematic, rigorous clinical research. The
advantage is that promising findings from basic research can rapidly be
translated into information to assist the practicing physician in
making the best possible decisions about how to treat patients. We
began in 1994 with clinical research networks for adult asthma and
acute respiratory distress syndrome (ARDS), and then moved on to
develop such a network for pediatric asthma. This year, we are
establishing a Thalassemia Clinical Research Network, which is expected
to provide an invaluable resource for evaluating new therapies for
patients with Cooley's anemia, who are few in number and widely
scattered across the country. We have also announced plans for a
similar effort in pediatric cardiovascular medicine, which will enable
rigorous testing of both medical and surgical approaches to treating a
variety of cardiovascular malformations in children.
Our experience with the ARDS Clinical Network illustrates the value
of this approach. ARDS is a form of respiratory failure that affects
about 150,000 Americans annually--many of whom were previously
healthy--and kills about half of them. We have struggled with it for 30
years, but made very little headway, in part because of the daunting
logistics of attempting to conduct timely and meaningful clinical
trials in large numbers of critically ill patients. The ARDS Network,
established in 1996, has already moved the field forward immeasurably
by establishing the effectiveness of an innovative approach to
mechanical ventilation. The new approach was shown to reduce mortality
by 25 percent--a remarkable achievement for a disease in which
mortality had remained stubbornly high despite many years of research.
The results of this study are currently being implemented in intensive
care units throughout the world. It is evident that clinical research
networks save time, save money, and produce results of tangible value
to the patient.
FOCUS ON THE INDIVIDUAL PATIENT
One of the most promising new developments that we foresee is the
increasing ability to understand individual susceptibility to a
disease, or individual response to an intervention, so that we can
target our treatments accordingly. We currently employ many broad--
brush approaches in the expectation that at least a portion of the
population will benefit. For example, we recommend that everybody limit
sodium intake to prevent high blood pressure--prudent advice, in that
the subset of people who are sensitive to salt will profit and no harm
will come to others. All the same, it makes for a fairly ``weak''
public health message that has not been universally adopted. On the
horizon, however, are several promising tests to identify salt
sensitivity; they may enable us to more narrowly focus our dietary
recommendations and, thereby, gain the attention of individuals who
most need to heed them.
A second example is in the area of sudden cardiac death, a fatal
arrhythmia that claims the lives of about 150,000 Americans annually.
There is much recent interest in placing automatic defibrillators in
public places to ``rescue'' victims of this malady, and we have just
initiated a community-based research program on the topic. However,
this is an after-the-fact approach, and it is clear that much more
could be achieved in the long run if we were able to identify
susceptibility to fatal arrhythmias and initiate preventive measures.
In this regard, we are greatly encouraged by research that points to
two possible approaches. One, called T-wave alternans, is a measure of
irregular electrical activity of the heart that appears to correlate
with the potential for life-threatening arrhythmia. An even simpler
approach--which might someday, for instance, be used by coaches to
screen young athletes--is suggested by the recent finding that a delay
in the return of the heart rate to a normal pace after exercise is
strongly predictive of mortality.
Of course, the hope of understanding individual response to
treatment or individual variations in the course of a disease is what
drives our efforts to unravel the genetic basis of disease, and we are
looking at many diseases in this light. With regard to congestive heart
failure, for instance, scientists have recently reported that a fairly
common gene variation is associated with disease severity, and we see
much potential for ultimately developing approaches targeted to
patients whose disease is likely to follow a rapid downhill course.
Particularly aggressive efforts are being made with respect to sickle
cell disease, which has long been a puzzle because all patients have
the same genetic ``mis-code'' yet the severity of the disease ranges
from mild to life-threatening. We recently initiated a new research
program to identify other aspects of a person's genetic make-up that
modulate disease severity. This work has taken on particular urgency
because we now have a cure for sickle cell disease in the form of stem
cell transplantation, but we have been reluctant to use it in this
country because it is literally a cure that can kill. If we were able
to distinguish, early in life, the patients who will suffer severely
from the disease, it would open the door to applying this treatment
selectively in cases where the potential benefits substantially
outweigh the risks.
ADDRESSING HEALTH DISPARITIES
Despite impressive strides toward our goal of disease prevention,
we are acutely aware that not all segments of society have benefitted
equally from this trend. Death rates from cardiovascular diseases, for
example, are disproportionately high among U.S. blacks--and among
blacks in Mississippi, they are the highest in the nation. The NHLBI's
Jackson Heart Study is exploring the reasons for this phenomenon in a
long-term study of 6,500 men and women. In addition to collecting data
on conventional risk factors, the study will focus on newer areas,
including early indicators of disease, genetics, socio-cultural
influences such as socioeconomic status and discrimination, and
physiological relations between common disorders that are related to
cardiovascular disease, such as high blood pressure, obesity, and
diabetes. We have emphasized the involvement of local people in the
development and support of this study, and are optimistic that it will
provide new directions for disease prevention in the black community.
NEUROFIBROMATOSIS
As a final note, we have been asked by the Committee to comment on
our activities with regard to neurofibromatosis, a condition that
appears to be linked to certain forms of congenital heart disease. The
NHLBI recently provided funding for some research in neurofibromatosis,
in the expectation that it may help unravel molecular pathways that
affect abnormal heart development not only in neurofibromatosis, but
also in other conditions. The NHLBI will be working with the National
Institute of Neurological Disorders and Stroke and other NIH components
to develop a workshop, planned for 2000, that will summarize the
current status of NIH-supported neurofibromatosis research, identify
needs and opportunities, and stimulate and focus future NIH research in
this area.
PRESIDENT'S REQUEST
I am pleased to present the President's non-AIDS budget request for
the NHLBI for fiscal year 2001, a sum of $2,069,582,000 which reflects
an increase of $108,679,000 over the comparable fiscal year 2000
appropriation. Including the estimated allocation for AIDS, total
support requested for the NHLBI is $2,136,757,000, an increase of
$110,327,000 over the fiscal year 2000 appropriation. Funds for the
NHLBI efforts in AIDS research are included within the Office of AIDS
Research budget request.
GOVERNMENT PERFORMANCE AND RESULTS ACT
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report,
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
I would be pleased to respond to any questions that the Committee
may have.
______
Prepared Statement of Dr. Harold C. Slavkin
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Institute of
Dental and Craniofacial Research (NIDCR) for fiscal year 2001, a sum of
$263.1 million, which reflects an increase of $14.1 million over the
comparable fiscal year 2000 appropriation. Including the estimated
allocation for AIDS, total support requested for NIDCR is $284.2
million, an increase of $15.0 million over the fiscal year 2000
appropriation. Funds for the NIDCR efforts in AIDS research are
included within the Office of AIDS Research budget request.
DISCOVERING SOLUTIONS TO COMPLEX PROBLEMS
In his classic analysis, The Structure of Scientific Revolutions,
Thomas S. Kuhn puts forward the concept of science as a pursuit to
solve complex problems. Solving problems can range from a chess match
between grandfather and granddaughter, to the challenges of discovering
fundamental principles of biological systems, finding solutions to
health promotion in a diverse society, preventing disease, and
designing ``smarter'' diagnostics and therapeutics for diseases and
disorders that compromise health. By discovering solutions to the
complex problems posed by craniofacial, oral and dental diseases and
disorders, NIDCR-funded scientists are fulfilling the mission of the
Institute to improve and promote health through research.
BURDEN OF DENTAL AND CRANIOFACIAL DISEASES AND DISORDERS
The mission of our Institute is to reduce the burden of diseases
and disorders that are among the most common health problems both
nationally and globally. The NIDCR supports research ranging from the
prenatal developmental processes that form the human face and
dentition, to the many local and systemic diseases and disorders that
involve craniofacial tissues and structures throughout the lifespan.
These include spontaneous preterm births possibly linked to maternal
oral infections, birth defects like cleft lip and palate, trauma to the
head, face and teeth, severe malocclusions, oral infectious diseases,
head and neck cancers and chronic and disabling facial pain. Oral
microbial infections producing dental caries, periodontal diseases,
candidiasis and herpes lesions are common. Chronic and disabling facial
pain is a major component of temporomandibular joint diseases (TMD),
Bell's palsy, trigeminal neuralgia and fibromyalgia. Oral
manifestations of systemic diseases such as AIDS, diabetes and
osteoporosis are also common. Finally, oral complications from both
cancer therapies and numerous therapeutic drugs often include yeast
infections termed candidiasis, xerostomia (dry mouth), aggressive
dental caries, and severe bone loss.
Health disparities are associated with the burden of these diseases
and disorders, falling disproportionately upon children and adults from
particular ethnic and racial groups, historically underrepresented
minorities, and lower socioeconomic classes. To accelerate discovery of
solutions to these complex problems, we plan to link research, training
and access to oral health care using innovative and collaborative
Centers to Reduce Oral Health Disparities located in critical areas
around the country. The emphasis is placed on the oral health needs of
children and their caregivers. We envision these Centers as
partnerships between academic health science institutions, state and
local health and health financing agencies, community and migrant
centers, Indian Health Service clinics, Centers for Disease Control and
Prevention (CDC)-sponsored Prevention Research Centers, minority and
minority-serving institutions, and other interested groups. Our
strategy is to partner with the Health Resources and Services
Administration (HRSA), CDC, the National Institute of Child Health and
Human Development (NICHD), the National Institute of Nursing Research
(NINR), and the NIH Offices of Behavioral and Social Sciences Research,
Research on Women's Health, and Research on Minority Health, with
funding to begin in fiscal year 2001.
GENE DISCOVERIES: THE RAPID RATE OF PROGRESS
NIDCR actively supports the rapid discovery of genes related to
inherited dental and craniofacial diseases and disorders, head and neck
cancer genes, and genes related to the pathogenicity of viral,
bacterial and yeast infections in the human mouth. The rapid rate of
progress in these three areas is highlighted in.
The discovery of craniofacial, oral and dental genes that are
altered or mutated in more than a thousand inherited diseases, leads to
smarter diagnosis and possibilities for improved treatments and new
biomaterials. Of the 5,878 gene loci relevant to inherited human
diseases, 1,250 of these are associated with craniofacial-oral-dental
diseases and disorders. Over the last 5 years, more than several
hundred mutated craniofacial regulatory and structural genes have been
found to cause abnormal formation of the skull, cranial sutures,
maxilla and mandible, teeth, tongue, salivary glands, bone, cartilage,
cementum, dentin, enamel and periodontal ligament. Curiously, many of
these genes involved in craniofacial development also have far-reaching
effects, directing formation of such diverse body parts as the brain,
limbs, thyroid glands, heart and kidney, and even has a role later in
life with neoplastic diseases such as the role of patched mutations in
Gorlin's syndrome. Furthermore, evidence is beginning to assist in
solving the complexities of multiple gene networks and their collective
interactions with environmental factors. For example, variant gene
forms for enzymes required for folic acid metabolism are implicated in
spina bifida and craniofacial malformations. We now assume that
multiple gene-environment interactions produce birth defects in more
than one hundred thousand babies each year. NIDCR is actively
collaborating with other NIH Institutes and federal agencies to reduce
the burden of craniofacial birth defects.
Discovery of the multiple and sequential gene mutations involved in
the progression of oral and pharyngeal cancer will result in early
diagnosis and improved treatments and therapeutics. The Head and Neck
Cancer Genome Anatomy Project, a collaboration between NIDCR and the
NCI Cancer Genome Anatomy Project (CGAP), was recently established.
Genes expressed in squamous cell carcinoma and normal head and neck
epithelial tissues are being compared. This strategy is expected to
identify a specific combination of multiple gene mutations involved in
the premalignant to malignant neoplastic process, and will also provide
clinically useful biomarkers that can be used for diagnosis and for
monitoring the progression of head and neck cancers.
A remaining complex problem is to determine how microbes living in
homeostatic ecosystems or biofilms in the mouth become infectious
pathogens. Discovery of microbial genes will lead to remarkable
advances in early diagnosis and targeted drug development for improved
treatments of oral infectious diseases. Since Antoni van Leeuwenhoek
invented the microscope and discovered microbes growing in biofilm
scrapings from his own teeth in the 17th Century, we have come to
understand that more than 6 billion microbes live in the oral cavity,
and these billions of microbes belong to a list of more than 500
different strains that continues to expand. Just 2 months ago,
scientists identified 37 previously unknown strains of bacteria that
reside in the biofilms on the surfaces of teeth. To address this
problem, NIDCR and other NIH Institutes have accelerated efforts to
decipher the genetic lexicon of 60 microbial genomes. Presently, NIDCR-
funded genome projects include the following microorganisms: Candida
albicans, Porphyromonas gingivalis, Streptococcus mutans,
Actinobacillus actinomycetemcomitans, Treponema denticola, and
Streptococcus sanguis. Genomic studies of seven additional microbial
organisms with significant roles in oral infections are planned for the
near future.
ORAL INFECTION LINKED TO SYSTEMIC DISEASE
There has been extraordinary progress in the understanding of
periodontal disease in the last 25 to 30 years. A most significant
discovery is our new appreciation for linkages between oral infection
and systemic diseases, and this paradigm shift has already provided
important new diagnostic, preventive, early intervention and treatment
strategies for patients with periodontal diseases and beyond. The
presence of oral infections has been associated with systemic diseases
including spontaneous preterm births, cardiovascular and pulmonary
diseases and diabetes. One example is particularly useful in conveying
how investments in scientific research may result in significant human
and cost savings benefits. Accumulating evidence suggests that maternal
infections are a major risk factor for spontaneous preterm babies.
Preliminary findings supported by NIDCR and NICHD suggest a dose-
response relationship between the level of maternal oral infection and
the risk of preterm low birth weight babies. The risk posed by the oral
infection may prove to be amenable to treatment interventions. If
successful, future intervention studies would demonstrate a cost
effective approach to reduce some of the burden of spontaneous
premature births.
GENES OF INFLAMMATION AND TOOTH LOSS
Molecular genetic studies have discovered genes that regulate
chronic inflammation processes and tooth loss. Papillon-Lefevre
syndrome (PLS) is a genetic disorder that typically affects both skin
and teeth. Two new studies have discovered gene mutations in the
cathepsin C gene (CTSC) as the primary cause of PLS. Severe early onset
periodontitis in PLS patients is unresponsive to traditional oral
therapies and results in premature loss of both primary and permanent
teeth; in some cases, all primary teeth are lost by age 4 years and all
permanent teeth are lost by age 14 years. The periodontitis infection
results in severe destruction of bone tissue in the jaws needed to
support the teeth. This new discovery demonstrates the emerging
significance of gene discovery and the availability of smarter
diagnosis and future therapies for the oral manifestations of systemic
inflammatory diseases and disorders.
GENETICS OF TOOTH AGENESIS
We are discovering that multiple gene networks are required to
produce teeth. Mutations in several of these genes have been found to
cause congenitally missing teeth. These molecular foundations will
eventually provide the basis for the biomimetic design and fabrication
of replacement teeth later in the 21st century. Nearly 20 percent of
the U.S. population has congenitally missing teeth. The missing teeth
are often third molars, but may be any of the other teeth found in the
human dentition. The forms of missing teeth ranging from least to most
severe, are called hypodontia, oligodontia, and anodontia,
respectively. Recent studies identified multiple gene networks that
control the formation of teeth. Mutations in two of these genes, in
particular, MSX1 and PAX9, have been discovered to cause missing teeth.
The MSX1 gene is essential to tooth development and is found in
chromosomes of multiple species including the fruit fly, the mouse, and
humans. In a mouse model, deletion of the MSX1 gene resulted in animals
with cleft palates and no teeth. Recently, selected families with
congenitally missing teeth, known as familial tooth agenesis, were
found to have a mutation in the human MSX1 gene. A second study,
published last month, found that a mutation in the PAX9 gene resulted
in congenitally missing molar teeth in three generations of a
particular family. PAX9 is a member of a transcription factor family of
genes involved in eye, primary and secondary palate, tooth, and thyroid
gland formations. These discoveries are rapidly becoming gene-based
diagnostics for dental anomalies, and also provide a biological basis
for the future design and fabrication of tooth replacements.
The NIH budget request includes performance information required by
the Government Performance and Results Act (GPRA) of 1993. Prominent in
the performance material is the first NIH performance report, comparing
fiscal year 1999 results to the goals in the fiscal year 1999
performance plan. As our performance measures mature and trends emerge,
the GPRA data will serve as indicators to support the identification of
strategies and objectives to continuously improve programs across the
NIH and the Department.
Finally, I want you to know how privileged I feel to have been
selected by Harold Varmus to be part of the leadership team at the NIH.
It has been a unique honor to lead the world's largest sponsor of
dental, oral and craniofacial research. My tenure at the NIH has been
memorable, including: Government shutdowns, the blizzard of 1996, a
50th anniversary and a name change for our Institute, growth of the
NIDCR portfolio into significant new scientific areas, remarkable
growth in NIH funding, development of novel funding mechanisms, and
most recently, another blizzard. I especially want to thank you Mr.
Porter and the Committee Members for your confidence and support over
the last 5 years as I have served as the sixth director of this
Institute. This coming July, my wife and I will return to our home in
California and I will return to the private sector. Thank you. My
colleagues and I will be happy to respond to any questions you may
have.
______
Prepared Statement of Dr. Allen M. Spiegel
Mr. Chairman and Members of the Committee: I am pleased to testify
on behalf of the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK). This year is the NIDDK's 50th anniversary. I
have been with the Institute for nearly 27 of those 50 years--for the
past 3 months as Institute Director. Throughout this time I havehad the
privilege of conducting and directing basic and clinical research,
often in collaboration with superb investigators at many academic
centers and at NIH. The unique juxtaposition of laboratories and
patient facilities in the NIH Clinical Center has afforded me a
valuable perspective on the connections between basic and clinical
research. As NIDDK Director, one of my main goals will be to strengthen
those connections in order to accelerate progress toward relieving the
burden of the many chronic and costly diseases within our mission. The
challenges posed by these diseases are enormous. Significant gaps in
our knowledge concerning their causes leave us as yet unable to prevent
or treat them as effectively as we would wish. Yet, we are poised as
never before to make dramatic progress in closing these gaps. New,
powerful tools are becoming available to propel our progress. The
support provided to NIH and NIDDK has been greater than ever before.
Thus, it is with great scientific excitement and optimism that I have
accepted the challenge, as Director of NIDDK, of leading the effort to
alleviate the burden of diabetes, endocrine and metabolic diseases;
digestive and nutritional disorders; and kidney, urologic and blood
diseases.
POWERFUL RESEARCH TOOLS
Shortly, we will have in hand the sequence of the entire human
genome. Merely knowing the sequence, however, does not allow one to
utilize this powerful tool. This sequence or ``book of life'' is not
written in English and lacks obvious punctuation marks. An NIDDK
intramural scientist has recently discovered gene ``insulators,'' a
type of punctuation mark that allows a gene to be expressed without
interference from surrounding regions. This discovery is already
finding wide application in the biotechnology industry. Within the
``book of life'' are genes that either cause or contribute to many of
the diseases within our mission. Our task in making full use of the
human genome sequence is to identify all the genes within it, discover
their function and how changes in these genes cause disease. New tools
such as microarray technology allow simultaneous measurement of changes
in expression of thousands of genes. Bioinformatics methods allow us to
analyze vast amounts of sequence information. These tools will help us
to apply new genetic knowledge to revolutionize diagnosis, prevention
and treatment of many diseases.
Bioinformatics methods have revealed that many human genes have
counterparts in the genomes of yeast, roundworm and fruitfly. The
function of these genes can thus be studied at the cellular level in
these experimentally simpler model organisms. Vertebrate models such as
zebrafish and mouse, while more difficult to study than worms or flies,
are closer in organ structure and genetic sequence to humans. Zebrafish
mutants with disorders of red blood cell formation or of appetite
regulation have been discovered. Mouse mutants expressing too much or
too little of almost any gene in any organ can now be created. Such
models not only help clarify the function of genes and their role in
causing disease, but also provide systems for testing possible
treatments and preventions in ways not feasible in humans. Powerful
imaging methods are being developed that will allow detection of subtle
changes at the cell and organ level, thereby helping to elucidate the
causes of disease, monitor disease progression, and assess preventive
or therapeutic measures not only in animal models but in humans.
Bioengineering approaches to cell and organ replacement hold great
promise as well.
RESEARCH ADVANCES: PKD, HEPATITIS C, AND DIABETES
Polycystic kidney disease (PKD) is one of the most common inherited
disorders and the fourth leading cause of end-stage kidney failure,
according to the U.S. Renal Data System. A long hunt led to
identification of the gene responsible for the most common form of PKD,
and shortly thereafter, researchers found a second gene responsible for
a rarer form. The molecular function of these two gene products is
still incompletely understood, but the recent surprising discovery in
the roundworm--that mutations in one of the corresponding genes leads
to defects in the functions of sensory neurons--opens up new avenues to
understand the basic defect in PKD. Studies of PKD genes in humans have
established that cyst formation is an abnormal growth process,
analogous to benign tumor formation. Indeed, just last month, NIDDK-
supported investigators reported that treatment with an inhibitor of a
cellular receptor for a growth factor in a mouse model of PKD prevents
cyst formation and dramatically enhances survival. Of course, further
studies are needed before human trials, but NIDDK is already supporting
research to develop noninvasive imaging methods to monitor cyst growth.
Such methods will be critical in evaluating the effectiveness of new
treatments.
The CDC estimates that 4 million Americans are infected with the
hepatitis C virus. Hepatitis C is the most common cause of chronic
hepatitis and the most common reason for liver transplantation in the
United States. Epidemiologic studies show that 70 to 80 percent of
infected individuals fail to clear the virus and as many as 20 percent
of these develop chronic liver disease. Intramural NIDDK studies first
showed that interferon, an antiviral agent, is effective in treating
hepatitis C, but it completely clears the virus in only a small
minority of patients. Recently, NIDDK investigators reported a major
advance in treatment; by combining interferon with another antiviral,
ribavirin, they were able to clear the virus in up to 40 percent of
patients. Developing even more effective treatments and a vaccine to
prevent infection remain as major challenges.
According to data compiled by the congressionally established
Diabetes Research Working Group, diabetes affects an estimated sixteen
million Americans. It is a chronic and costly disease both in human and
financial terms. The complications of uncontrolled elevation in blood
sugar make diabetes the leading cause of end-stage kidney failure,
adult blindness, and non-traumatic amputations, and a major risk factor
for heart disease. Type 1 diabetes affects primarily children and young
adults, with more than 13,000 new cases per year in the United States.
This form of the disease is characterized by autoimmune destruction of
the insulin-secreting beta cells of the pancreatic islets. Type 2
diabetes affects primarily adults, and is increasing in the United
States at an alarming rate, nearly 800,000 newly diagnosed cases per
year. It is caused by both reduced insulin secretion and resistance to
insulin action. Genetic abnormalities contribute to both forms of
diabetes, but unlike single gene disorders such as PKD, most cases of
diabetes are thought to be due to subtle abnormalities in multiple
genes. Even before completion of the human genome sequence and full
deployment of new genetic tools, significant progress has been made in
identifying genes that cause diabetes. Why is such information
important?
In type 1 diabetes, knowledge of which genes predispose to the
disease should allow identification of those at risk and to whom
preventive measures should be targeted. Advances in understanding the
immune basis for type 1 diabetes have identified candidate
interventions to ``re-educate'' the immune system to prevent beta cell
destruction. One such intervention is being tested currently in an
NIDDK-supported multi-center trial. For those with type 1 diabetes in
whom beta cell destruction has progressed to the point where little or
no function remains, preventive measures are too late. The focus must
be on maintaining excellent control of blood sugar, as the landmark
Diabetes Control and Complications Trial showed clearly that intensive
treatment with insulin can prevent or delay the onset of kidney, eye
and other complications. Trying to maintain tight control of blood
sugar with insulin treatment, however, can be difficult and
frustrating, particularly in children. For this reason, NIDDK is
committed to supporting research both to improve existing insulin
treatment and to find innovative, new treatments that will represent a
true cure for this disease. Recent improvements in glucose-sensing
devices that can eliminate the need for multiple finger sticks
represent a small step toward the goal of an artificial pancreas.
Recent animal studies using novel methods to block the immune system
have demonstrated the feasibility of pancreatic islet transplantation.
These promising results are being carefully extended to studies of
kidney and islet transplants in humans in a newly opened NIDDK branch
in the NIH Clinical Center.
In type 2 diabetes, genetic studies have shown that rare forms of
the disease with onset at younger than usual age can be caused by
single gene mutations. At least five such genes, each involved in some
aspect of regulation of insulin secretion, have already been
identified. A striking example is the gene termed insulin promoter
factor-1, in which different degrees of mutation result in different
conditions. Mutation of both copies of this gene leads to failure of
the entire pancreas to develop. A severe mutation in one copy of the
gene is one cause of the rare forms of early onset type 2 diabetes.
Recent studies have shown that more subtle mutations of the same gene
contribute to the more common form of type 2 diabetes by impairing
insulin secretion. Identification of disease genes is important in
providing novel targets for drug development and in enabling
individualized therapy that is optimally effective for each patient.
Another recent advance illustrates how information about a drug
target can be used to identify a new diabetes gene. A new class of
diabetes drugs that increase insulin sensitivity was shown to act on a
cell receptor protein termed PPAR-gamma. This led investigators to
search for mutations in the gene for PPAR-gamma in type 2 diabetes
patients. Such mutations were found in rare patients with an early
onset form of diabetes characterized by insulin resistance, high blood
pressure, and abnormal blood lipids. Because all of these features are
frequently seen in patients with type 2 diabetes, more subtle defects
in the PPAR-gamma gene may be responsible for more common forms of type
2 diabetes. Thus, understanding the genetic basis of even rare forms of
type 2 diabetes is important, not only for care of patients with those
forms of the disease, but also for what it can tell us about the causes
of more common forms.
FUTURE RESEARCH PLANS
While these advances are indicative of the important progress we
have made, clearly extraordinary challenges remain for virtually all
the diseases within the NIDDK mission. Indeed, the congressionally-
established Diabetes Research Working Group identified five
extraordinary diabetes research opportunities: genetics, autoimmunity
and the beta cell, cell signaling and regulation, obesity, and clinical
research and trials. The NIDDK intends to seize each of these
opportunities. To take full advantage of the soon available human
genome sequence, we will bolster a consortium formed to identify type 2
diabetes genes and try to form a similar group to identify type 1
diabetes genes. We will form a diabetes trial network to do pilot
studies of innovative methods to prevent type 1 diabetes, as clues
emerge from studies of the mechanism of beta cell destruction. We will
stimulate research using the most advanced methods to image islet beta
cells, so that effectiveness of diabetes preventions can be sensitively
monitored, and more rapidly tested. We will expand our support for
studies of islet transplantation in humans by establishing a consortium
and an islet transplant registry so that progress may be maximized. We
will form a ``Virtual Center'' of interdisciplinary investigators whose
goal will be a complete understanding of the biology of the beta cell.
This will include identification of every gene expressed at every
developmental stage and their regulatory interactions, so that we would
ultimately know how a stem cell differentiates to become a beta cell.
It would include elucidation of all the signaling pathways regulating
insulin secretion, so that we would know every step at which this
process can malfunction and identify new targets for correction. We
will form a consortium of investigators who will create new mouse
models to understand the causes and test possible treatments for the
complications of diabetes. We will launch a major new trial to study
whether sustained weight loss can be achieved in obese individuals with
type 2 diabetes, and if it can, to determine whether this is in fact
beneficial to health. We also plan an obesity prevention initiative
building on recently successful pilot programs.
Health disparities pose a particular challenge for NIDDK, because
minorities are disproportionately affected by many of the diseases for
which we have research responsibility including type 2 diabetes,
hepatitis C, and end-stage kidney failure. Our major type 2 diabetes
prevention trial has enrolled nearly fifty percent of its patients from
minority groups, and we will be supporting a new initiative directed at
the alarming incidence of type 2 diabetes in children, especially from
minority groups. We are supporting efforts to understand why certain
groups such as African-Americans and Native Americans show increased
susceptibility to the kidney complications of diabetes, so that we can
learn how to prevent them. We are planning a clinical trial of
interferon treatment in African-Americans to determine why they are
less responsive to treatment. This should lead to improved therapies.
In addition to these areas, NIDDK will be emphasizing basic and
clinical studies of prostate disorders, such as BPH and prostatitis;
bladder disorders such as interstitial cystitis; inflammatory bowel
disease and irritable bowel syndrome; progressive kidney failure; food-
related illnesses; and other health problems within our research
mission.
In developing our future research agenda, we have the benefit of
input from our National Advisory Council, from our many constituency
organizations both lay and scientific, and from investigators attending
the scientific workshops convened by our staff. As the new NIDDK
Director, I have already met with many of these groups and will
continue actively to reach out to them, so that we may effectively
collaborate in framing future research directions. Working together, we
can take full advantage of this unique time of scientific momentum to
mobilize the national biomedical research enterprise for the benefit of
all the people of this country.
I am pleased to present the President's non-AIDS budget request for
the NIDDK for fiscal year 2001, a sum of $1.186 billion which reflects
an increase of $66.8 million over the comparable fiscal year 2000
appropriation. Including the estimated allocation for AIDS, total
support requested for the NIDDK is $1.209 billion, an increase of $67.8
million over the fiscal year 2000 appropriation. Funds for the NIDDK's
efforts in AIDS research are included within the Office of AIDS
Research budget request.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report,
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
______
Prepared Statement of Dr. Gerald D. Fischbach
Mr. Chairman and Committee Members: I am pleased to present the
President's non-AIDS budget request for the NINDS for fiscal year 2001,
a sum of $1,050,412,000, which reflects an increase of $54,327,000 over
the comparable fiscal year 2000 appropriation. Including the estimated
allocation for AIDS, total support requested for NINDS is
$1,084,828,000, an increase of $55,085,000 over the fiscal year 2000
appropriation. Funds for the NINDS efforts in AIDS research are
included within the Office of AIDS Research budget request.
I became Director of NINDS eighteen months ago with great
enthusiasm about neuroscience research and the likelihood of
significant advances in treating neurological disorders that were
considered intractable only a few years ago. My enthusiasm has grown
with time because new discoveries, generous public support and a
widening sphere of collaborations within the NIH and with outside
organizations have brought our mission of reducing the burden of
neurological diseases into clearer focus.
We are now in the second year of a strategic planning process that
has galvanized our research and patient communities as well as our own
staff. Last year's planning document, ``Neuroscience at the New
Millennium,'' identified major targets of opportunity and laid out a
strategy for approaching disease problems and for strengthening the
capacity of the research community to continue the stunning advances of
recent years. The momentum generated by this process, that engaged
efforts of more than 100 distinguished extramural and intramural
scientists, professional societies, and many patient advocates,
resulted in many new initiatives. The Strategic Plan is based on the
cross-cutting topics of neurodegeneration, neural repair,
neurodevelopment, neurogenetics, synapses and circuits, cognition and
behavior, and the neural environment. Our Plan is now in its second
phase. Because the planning panels were so successful, we reorganized
the extramural program staff into working clusters that track the major
planning topics. This flexible, non-hierarchical structure has led to
productive interactions among our program directors, senior staff, and
external advisors in advancing our research agenda and in responding to
the initiatives of investigators and to concerns of the lay members of
the planning community.
USES OF FISCAL YEAR 2000 INCREASE
The fiscal year 2000 appropriation will allow NINDS to maintain and
build on critical initiatives begun in fiscal year 1999 and to take
advantage of new, extraordinary opportunities, including support of 200
more project grants and 50 more scientists in training and career
development. I am pleased to report that in fiscal year 1999 we were
able to fund eight new Morris K. Udall Centers of Excellence in
Parkinson's Disease, instead of the five we had planned. Together with
the three Centers funded in late 1998, we now have a national network
of eleven Centers that includes a wide spectrum of basic and clinical
research. Annual meetings of the Centers, along with ongoing informal
interactions, will increase opportunities for collaboration and
maximize this significant investment. Each Center has a training
component, so new investigators will be introduced to Parkinson's
disease and related disorders each year.
Another new initiative this year seeks to explore the promising new
technology of deep brain stimulation in Parkinson's disease and other
neurological disorders. Studies of electrode design, patterns of
stimulation, and clinical trials will determine if DBS can halt the
progress of neurodegeneration as well as reverse disabling symptoms.
Another solicitation is concerned with the safety of the blood
supply. We seek a rapid and sensitive test for the infectious agent
(prion) responsible for the new variant Creutzfeldt-Jakob Disease. The
public must be confident in the safety of the blood supply.
During the current year we will expand our efforts to apply
sophisticated technology to map the location and timing of gene
expression in the brain. This is an essential step in determining the
function of normal and mutant, disease-causing genes. We will expand
our successful neural prosthesis program, and we will develop
innovative, high throughput screens for potential therapeutic agents.
We intend to promote new approaches to spinal cord injury, and we plan
a broad approach to analyze the efficacy of neural stem cells in
repairing focal and generalized lesions. Building on one of our most
successful innovations in fiscal year 1999, we plan to expand our
support for a full range of infrastructure needed for modern
neuroscience research. Finally, we plan to increase our investment in
training physician-scientists who are most likely to engage in
translational research and patient oriented research. Looking to the
future, I would like to tell you about just a few of our major
initiatives and priorities for fiscal year 2001.
A HEALTHY BRAIN FOR LIFE
We are concerned with neurological disorders over the entire
lifespan. It is important to focus on developmental and degenerative
disorders of children that can produce a lifetime of disability. Our
efforts range from a new, exploratory grants program looking for new
insights into common disorders such as autism and epilepsy, rare
disorders such as Rett's Disease, Batten's Disease, and lipid storage
diseases. We have emphasized gene discovery in epilepsy because it
seems that even the most common forms such as febrile convulsions have
a heritable component. At the same time we seek to promote better
treatments, and even a cure, for the large number of people with
``intractable'' epilepsy. Many of these individuals are children, whose
lives are disrupted by inadequately controlled seizures. Later this
spring we will sponsor a White House-initiated conference, ``Curing
Epilepsy: Focus on the Future.''
HALTING THE PROCESS OF NEURODEGENERATION
As requested by the Appropriations Committees, NINDS is working on
the first phase of an effort to develop a comprehensive research agenda
for Parkinson's disease. We were joined in this effort by NIH
Institutes and Centers with significant programs in Parkinson's
disease, by patient advocacy groups, and by distinguished intramural
and extramural scientists. We are confident that the proposed research
agenda will advance the fight against Parkinson's disease and point the
way for similar progress in other neurodegenerative disorders.
Neurodegeneration is more widespread than previously thought. In
addition to classical adult neurodegenerative disorders such as
Alzheimer's, Parkinson's, Huntington's and Lou Gehrig's diseases,
neurodegenerative processes are at work in a number of serious
disorders of childhood. Neurodegeneration also complicates conditions
as disparate as stroke, spinal cord injury, epilepsy, multiple
sclerosis, and depression. A cell death program, named apoptosis,
appears to be a ``final common pathway'' in the process of
neurodegeneration. Encouraging evidence indicates that inhibition of
this pathway may be a useful therapeutic strategy, regardless of the
initial causes of the degeneration.
We must not lose sight of our goal of cognitive and emotional
health throughout life. The study of disease is teaching us that
decline in cognitive and emotional health is not an inevitable
consequence of aging. For many, perhaps most of us, a healthy brain is
as realistic a goal as is a healthy heart. But we cannot achieve our
goal without a much better understanding of disease, particularly the
risk factors and early changes that point to possible preventive or
corrective measures. A new patient registry for Parkinson's disease, to
be followed by a larger population-based study, will point the way to
further study of neurodegenerative diseases at every stage of life.
Through collaboration with other Institutes, we will expand these
studies to include cognitive and emotional disorders and to define and
promote cognitive and emotional health across the life span.
REPAIRING THE INJURED NERVOUS SYSTEM
Modern neuroscience is rewriting the textbooks that tell us that
nerve cells cannot recover from deadly injury. Research on a number of
fronts has produced tantalizing evidence that manipulating the cells'
environment--by adding factors that promote growth or interrupting
processes that disrupt it--will eventually redefine the future for
those who have lost function due to injury. A recent initiative is
seeking additional research on interneuronal circuits to restore lost
function. As in so many other areas of neuroscience, the ability to
manipulate and implant stem cells from a variety of sources is
particularly promising for both acute and chronic injury. Complementing
these efforts are advances in our ability to design neural prostheses-
devices that connect with the patient's own nerves and muscles to
restore or augment function.
REDUCING HEALTH DISPARITIES
As we rejoice in the progress of modern medicine, we must not
neglect those who, by virtue of biology or circumstance, bear a
disproportionate share of the burden of disease. NINDS enthusiastically
shares the commitment of NIH to reducing health disparities, and we
will continue our leadership in this area. Stroke is a major health
problem for the entire population but one that disproportionately
affects minority citizens, particularly African-Americans. We support a
broad program directed at the impact of stroke on minority populations,
ranging from epidemiological and descriptive studies of disease
patterns to specific therapies and educational approaches. The
neurological complications of diabetes, another common disorder that
particularly affects minority groups, is a major focus of interest.
Progress against health disparities also depends on building a
diverse scientific workforce--a strategy that makes sense in general
but is particularly important in working with minority populations.
NINDS has a long history of leadership on this front. More recently,
with support from the Office of Research on Minority Health, we
initiated the first prototype of a Specialized Neuroscience Research
Program (SNRP) at the Morehouse School of Medicine in Atlanta. A unique
feature of the program is the establishment of collaborations and
professional networks between investigators at minority institutions
and those from more research intensive institutions and community-based
organizations. Based on excellent results from the pilot program at
Morehouse, and recognizing the work still to be done, the NINDS, in
collaboration with NCRR, is now supporting additional SNRPs. This year
we will expand the program to include a focus on HIV/AIDS, a particular
problem in the nervous system, where the virus can cause dementia and
neuropathy even when other manifestations of disease are well
controlled.
WORKING TOGETHER TO FIGHT BRAIN DISEASE
Neuroscience is recognized as one of a few great unifying themes in
modern science. Nowhere is this more evident than at NIH, where almost
every Institute and Center is involved to some extent in brain
research. Here we have a unique opportunity to break down what is
increasingly recognized as an artificial barrier between mind and
brain, between neurology and psychiatry. Our goal is to develop a model
for collaborative neuroscience with an emphasis on translational
research. The National Neuroscience Research Center, for which start-up
funds are requested in the Buildings and Facilities budget, will
provide an environment that will promote modern neuroscience in the
form of collaboration, communication, and shared resources. It will
build on the impressive progress already made by intramural science
leaders and on the example being set by the National Vaccine Research
Program.
The emphasis on collaboration will, in my view, stand out as the
distinguishing feature of NIH in our time. NINDS is actively working
with one or more Institutes and Centers on diseases including autism,
Duchenne and facioscapulohumeral dystrophy, and neurofibromatosis. Our
efforts against neurodegenerative disease include collaborations with
the National Institute of Aging on clinical trials for Alzheimer's
disease and with the National Institute of Environmental Health
Sciences on Parkinson's disease, as well as plans for an innovative
public-private partnership to foster future research. Our collaboration
with the National Cancer Institute to map the genes involved in a
deadly form of brain tumor has blossomed into the formation of a joint
Progress Review Group for brain tumor research, building on a planning
technique that has been highly successful for research on other forms
of cancer. In stroke, we have joined forces with the National Heart,
Lung, and Blood Institute and with Suburban Hospital in Bethesda to
improve rapid diagnosis and treatment of both stroke and heart disease.
We continue to work with the Brain Attack Coalition to raise public and
professional awareness of stroke as a preventable and treatable
disease.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department. For NINDS, this
effort will be augmented by our strategic planning process, which
provides an ongoing forum for assessing progress and setting
priorities, and by our strong commitment to efficient and effective
management of our resources.
Mr. Chairman, this concludes my prepared statement. I would be
happy to answer questions you or the other Members may have.
______
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) for fiscal year 2001. The non-AIDS
portion of the budget request is $935,166,000, which reflects an
increase of $54,019,000 over the comparable fiscal year 2000
appropriation. Including the estimated allocation for AIDS, total
support requested for NIAID is $1,906,213,000, an increase of
$109,582,000 over the fiscal year 2000 appropriation. Funds for NIAID
efforts in AIDS research are included within the Office of AIDS
Research budget request. I would note that the National Institutes of
Health (NIH) budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report,
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan.
GLOBAL HEALTH
The NIAID research program is predicated on the view that we live
in an interconnected, global community. Because of the enormous volume
of international travel and trade, we cannot separate the health
problems of the United States from those of the rest of the world.
Clearly, it is folly to think that we are somehow isolated from
diseases that are public health challenges elsewhere. In 1999 alone, we
witnessed the first known appearance of West Nile fever in the western
hemisphere (in New York City and surrounding areas), as well as
alarming reports of dengue fever outbreaks in Texas and Florida. The
yearly U.S. epidemic of influenza, which originates in Asia, is the
prototypic example of the maxim ``microbes do not recognize borders.''
Indeed, the memory of three recent influenza pandemics (1918, 1957 and
1968), as well as the ever-present threat of another flu pandemic is
perhaps the best reminder of humanity's shared vulnerability to
disease.
As a nation, our interest in global health stems both from
humanitarian concerns and what has been called ``enlightened self-
interest.'' In addition to our obligation to ameliorate human suffering
wherever possible, history tells us that healthy, stable countries make
strong allies and trading partners. Conversely, poor health status can
have a profound negative impact on social and economic development, and
frequently contributes to political instability. Significantly, this
year the United Nations Security Council for the first time devoted an
entire session to a health issue--AIDS in Africa--recognizing the
enormous threat that the disease poses to the security not only of that
continent but the world.
INFECTIOUS DISEASES: CHALLENGES AND OPPORTUNITIES
The World Health Organization (WHO) estimates that 1,500 people die
each hour from an infectious disease. Half of these deaths occur in
children under five years of age, and most of the rest are working
adults who frequently are breadwinners and parents. Virtually every
year one or more newly recognized diseases add to the burden of known
infectious conditions; in 1999, for example, the deadly Nipah virus
emerged in Malaysia and Singapore. Because of the emergence of
microbial drug resistance, many infectious diseases are increasingly
difficult to treat. In addition, it is now clear that many chronic
diseases have an infectious etiology: approximately 20 percent of all
cancers are related to infections, and mounting evidence indicates that
pathogenic organisms may be the underlying causes of chronic diseases
such as coronary artery disease, diabetes, multiple sclerosis, and
chronic lung diseases.
NIAID's Strategic Plan, available on the World Wide Web at http://
www.niaid.nih.gov/strategicplan outlines the progress made in
infectious disease research, including advances in HIV treatment,
prevention and vaccine development, and delineates the scientific
opportunities to strengthen our preparedness for infectious threats,
known and unknown.
THE PROMISE OF PATHOGEN GENOMICS
Many of the challenges posed by infectious diseases lend themselves
to research in a relatively new field: pathogen genomics, or sequencing
of the genes of microbes, a central focus of the Institute. Pathogen
genomics, coupled with data from the Human Genome Project, as well as
the use of new tools such as microarray and DNA ``chip'' technologies
to delineate the functional expression of these microbial genes, will
likely underpin infectious diseases research for the coming decades and
will be critical to the development of new vaccines, therapies and
diagnostics.
In an important technical achievement, researchers have determined
the complete genetic sequence of chromosomes 2 and 3 of P. falciparum,
the most deadly malaria parasite. This new information will help to
identify virulence factors and proteins involved in the parasite's
lifecycle that may serve as targets for the development of drugs and
vaccines. Researchers also have determined the complete genomic
sequence of two strains of M. tuberculosis, the TB bacterium. These
sequencing efforts are central to NIAID's detailed plans for the
development of malaria and TB vaccines.
NIAID-supported researchers have also published complete or partial
genomic sequences of the agents of the sexually transmitted diseases
chlamydia and syphilis, as well as the leishmaniasis parasite
Leishmania major. The Institute also supports the genetic sequencing of
many other important pathogens that exact an enormous toll and are
increasingly drug-resistant. Examples include important species of
enterococci, streptococci, and staphylococci, including Stapyhlococcus
aureus, which in some cases has become virtually untreatable because of
drug resistance.
VACCINE DEVELOPMENT
Vaccination has been recognized as the greatest public health
achievement of the 20th century, and vaccine research has long been a
cornerstone of the NIAID research portfolio. NIAID-supported research
has been instrumental in the development of many new and improved
vaccines, such as those against hepatitis A and B, Haemophilus
influenzae type b, pertussis, typhoid, varicella, and pneumococcal
disease. A new vaccine against Streptococcus pneumoniae, the leading
cause of morbidity and mortality in children worldwide, shows
particular promise. Widespread use of this vaccine could greatly reduce
the 1.2 million child deaths worldwide attributed to S. pneumoniae each
year, according to WHO. The domestic potential of this new vaccine is
also significant: pneumococcal disease causes 40,000 deaths, 500,000
cases of pneumonia, and 7 million middle ear infections in this country
every year, according to CDC.
The rapidly evolving science base in pathogen genomics, immunology
and microbiology will facilitate further progress in developing new and
improved vaccines. In particular, vaccines that target mucosal surfaces
such as those in the intestine or respiratory tract are of great
importance, because many pathogens gain entry to the host via mucosal
sites. Vaccines administered orally, nasally or transdermally are easy
to administer and therefore have potentially great utility in
developing countries and for mass immunization programs. The
development of new adjuvants, which boost the immune response to
vaccines, is another important area of research that has progressed
rapidly in recent years. In addition to the development of vaccines
against classic infectious diseases, vaccines are being pursued to
fight potential agents of bioterrorism; chronic diseases with
infectious origins; and autoimmune diseases and other immune-mediated
conditions.
ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS)
AIDS, caused by the human immunodeficiency virus (HIV), is one of
the greatest threats to global health and one of the most destructive
scourges in human history. Since the beginning of the HIV pandemic,
more than 50 million people worldwide have been infected with HIV, of
whom more than 16.3 million have died, according to UNAIDS. In the
United States, approximately 650,000-900,000 people are living with
HIV/AIDS; an additional 420,200 people with AIDS had died as of June
30, 1999, according to the Centers for Disease Control and Prevention
(CDC). UNAIDS estimates that the global HIV-infected population
continues to expand: in 1999 alone, there were 5.6 million new
infections worldwide, half of which occurred among people younger than
25 years of age. In the United States, the rate of new HIV infections
has reached an unacceptable plateau of 40,000 per year, with minority
communities disproportionately affected.
Although potent combinations of anti-HIV drugs have reduced the
number of AIDS deaths and new AIDS cases in many western countries, the
utility of these medications is limited by their substantial cost,
toxicities, complicated and disruptive dosing regimens, and the
development of drug resistance. Many patients do not respond adequately
to current regimens; even in patients who are successfully treated, the
virus persists in sanctuaries where the drugs cannot penetrate and in a
latent form on which the drugs have no effect. Therefore, the
development of a new generation of therapies remains a major priority.
In addition, approaches to purging the virus from its sanctuaries in
certain cells and tissues are being vigorously pursued, as are methods
to boost the body's immune defenses so they can better fight the virus.
In developing countries in which per capita health care spending
may be only a few dollars a year, and where health care infrastructures
are weak, anti-HIV therapies are invariably beyond the reach of all but
the privileged few. This situation, coupled with the upward trajectory
of the global HIV/AIDS epidemic, underscores the urgent need for
effective and affordable tools of HIV prevention. Notable progress has
been made. For example, an NIAID-supported study in Uganda found that
two doses of the drug nevirapine, one given to the mother at the onset
of labor and one given to the infant within 72 hours after birth, can
markedly reduce perinatal HIV transmission. The entire regimen costs
$4.00, making it feasible in resource-poor settings. Other methods of
preventing HIV transmission, such as education and behavior
modification and the social marketing and provision of condoms have
also proven effective, both in the United States and in developing
countries such as Uganda, Senegal and Thailand.
Approximately 46 percent of people living with HIV/AIDS are women.
An important NIAID focus is developing interventions that will empower
women to protect themselves in situations where they are unable to
avoid sex with HIV-infected partners or cannot persuade their partners
to use a condom. A critical effort is the development and testing of
products for vaginal use--called topical microbicides--that may protect
women (and their partners) from HIV and other sexually transmitted
diseases. Promising microbicide candidates are now in various stages of
testing in animal models and in humans.
The development of a safe and effective vaccine for HIV infection
is a central goal of AIDS research, and a necessary tool to bring the
HIV epidemic under control. In addition to the Institute's substantial
commitment to pre-clinical HIV vaccine research, NIAID has conducted
more than 50 clinical studies of HIV vaccines. Among these is the first
HIV vaccine trial in Africa, a study initiated in Uganda last year in a
growing effort to collaborate with scientists from developing countries
to identify safe and effective vaccines suitable for worldwide use.
Last year also marked the dedication of the Dale and Betty Bumpers
Vaccine Research Center, a program within the NIH intramural research
program to stimulate multidisciplinary vaccine research.
IMMUNE-MEDIATED DISEASES
The burden of immune-mediated diseases is staggering; these
conditions, like infectious diseases, are important global health
concerns. For example, 100 to 150 million people worldwide suffer from
asthma; in this country alone, 15 million people are asthmatics.
Asthma-related deaths worldwide number approximately 180,000 annually
and are increasing both in the United States and abroad.
The past two decades of intense and highly productive research on
the immune system have resulted in a wealth of new information and
extraordinary growth in conceptual understanding. These accomplishments
now provide realistic opportunities for major advances in the
diagnosis, treatment, and prevention of a broad range of immunologic
conditions.
Among the most exciting developments is our growing understanding
of tolerance induction. By blocking only those components of the immune
system that attack healthy tissues, it may be possible to prevent graft
rejection in transplant patients without immunosuppressive drugs that
dampen protective immune responses as well as deleterious ones. The
ability to selectively block the immune response also holds great
promise for treatment of many immune-mediated conditions, including
autoimmune diseases such as juvenile (type 1) diabetes, rheumatoid
arthritis and multiple sclerosis, as well as asthma and allergic
diseases. In addition, understanding the mechanisms of immune tolerance
will likely prove important for efforts to prevent unresponsiveness to
vaccines, and for enhancing natural host responses and defenses to
infection.
In October 1999, NIAID launched a major initiative to develop new
ways of inducing immune tolerance, in partnership with the Juvenile
Diabetes Foundation International and the National Institute of
Diabetes and Digestive and Kidney Diseases. The Collaborative Network
for Clinical Research on Immune Tolerance involves more than 40
research institutions. Network researchers will conduct clinical trials
to improve the success of kidney transplants using tolerogenic
approaches and clinical trials are planned for patients receiving
transplanted human islets to treat type 1 diabetes. Network
investigators will test similar therapeutic approaches for other
autoimmune diseases, such as systematic lupus erythematosus, rheumatoid
arthritis and multiple sclerosis, and will pursue better ways to
measure immune tolerance in humans. In addition, the network plans to
conduct clinical trials in immune modulation to treat asthma and
allergic diseases.
ADDRESSING HEALTH DISPARITIES
Virtually all of NIAID's research efforts address the health
disparities that exist in our country, as well as the growing gap in
health status between developed and developing countries. Perhaps the
best example of this is the development of vaccines to prevent
infectious diseases, which disproportionately affect the poor, both at
home and abroad. Other efforts, such as HIV treatment and prevention
research, hepatitis C research, asthma research, tissue typing and
other transplantation research, and autoimmunity research, address
conditions that exact a significant toll in minority communities. In
addition, NIAID has a long-standing commitment to increasing the cadre
of minority investigators involved in biomedical research.
CONCLUSION
The United Nations, in the International Declaration of Health
Rights, asserted that ``The enjoyment of the highest attainable
standard of health is one of the fundamental rights of every human
being. It is not a privilege reserved for those with power, money or
social standing.'' As the NIAID faces the new millennium, we anticipate
that our research efforts will result in new and improved vaccines,
diagnostics, and treatments that will make ``the highest attainable
standard of health'' a global reality.
______
Prepared Statement of Dr. Marvin Cassman
Mr. Chairman and Members of the Committee, good morning. I am
pleased to present the President's non-AIDS budget request for the
National Institute of General Medical Sciences (NIGMS) for fiscal year
2001, a sum of $1.389 billion, which reflects an increase of $73
million over the comparable fiscal year 2000 appropriation. Including
the estimated allocation for AIDS, the total support requested for
NIGMS is $1.428 billion, an increase of $74 million over the fiscal
year 2000 appropriation. Funds for the NIGMS efforts in AIDS research
are included within the Office of AIDS Research budget request.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report,
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
The mission of the National Institute of General Medical Sciences
is to support basic biomedical research that is not targeted to
specific diseases. NIGMS funds studies on genes, proteins, and cells,
as well as on fundamental processes like communication within and
between cells, how our bodies use energy, and how we respond to
medicines. The results of this research increase our understanding of
life and lay the foundation for advances in disease diagnosis,
treatment, and prevention. NIGMS attempts to ensure the vitality and
continued productivity of basic biomedical research, while producing
the next generation of scientific breakthroughs and training the next
generation of scientists. I am particularly pleased to announce that
once again the current Nobel laureate in physiology or medicine, Dr.
Gunter Blobel of Rockefeller University, was supported by NIGMS during
the period when the work for which he was recognized was performed.
SNAPSHOT OF THE CELL'S PROTEIN FACTORY
I would like to begin by describing a major advance of the past
year, the determination of the detailed structure of the ribosome. This
stunning accomplishment is the result of a broad body of research,
largely supported by NIGMS, over a period of several decades. The
ribosome is the particle in the cell where proteins are synthesized. It
is a factory, made up of many molecules, which is small by our daily
measures but is a giant compared to most other elements in the cell. It
carries out a central activity for life--the accurate synthesis of the
proteins that form the body's structures, such as muscle and collagen,
and that catalyze the chemical reactions in living systems.
Consequently, ribosomes are found everywhere in nature, and they don't
appear to differ much between species. It's as if nature got it right
the first time and didn't want to make many changes.
A major goal of modern biology has been to lay bare the mechanism
by which the protein synthesis factory functions. To do so, it was
ultimately necessary to identify, in great detail, the three-
dimensional structure of the particle, using x-ray crystallography as a
primary tool. The difficulties of this undertaking can be appreciated
when it is understood that the ribosome is made up of two subunits of
unequal size, comprised of a total of 54 individual proteins as well as
three RNA strands. The determination of a single protein structure can
still be a difficult process, so attempting to understand such a
complex entity was an intimidating prospect.
The astonishing breakthroughs of the past year are the result of
dogged effort, with contributions over many years from many sectors of
science. The next figure shows the different avenues of research
leading to the current achievements. It represents selected highlights,
with the NIGMS-supported efforts shown in yellow. What is clear is that
contributions were required from chemistry and physics, as well as
genetics, biochemistry, and structural biology, to arrive at our
current understanding. We are particularly pleased to have supported
Dr. Ada Yonath, from the Weizmann Institute of Science in Israel, at a
time when there was still great doubt that it would be possible to
achieve the structure. This investment, and our subsequent support over
15 years, demonstrates the value of funding high-risk, high-payoff
approaches.
Although the detail currently visible is not yet at a level
sufficient to identify individual atoms, we are confident that the
research teams we are supporting will arrive at this goal. This should
provide unique insights into antibiotic action and resistance, since
many antibiotics--including erythromycin and tetracycline--work by
blocking bacterial ribosome function. Even this will only mark a new
beginning, since, as with any factory, the various machines operate to
absorb raw material, process it, and then release it in a form that can
be used. To follow this process, it will be necessary to capture and
visualize the machine at different points in the manufacturing cycle.
But this is yet to come, and where we are today is exciting enough, for
the new knowledge will greatly improve our understanding of a
fundamental component of living systems.
MAJOR INITIATIVES
I would like to spend the rest of my time describing some of the
opportunities that are being addressed with the increased funds that
Congress appropriated to NIGMS. In particular, I would like to focus on
three new initiatives--pharmacogenetics, structural genomics, and
large-scale collaborative research--and then close with a description
of the expansion in our support for minorities in research.
Pharmacogenetics is the effect of inheritance on drug action. In
1998, it was reported that adverse drug effects account for 100,000
deaths per year, as well as 5-10 percent of hospital admissions. The
old joke of ``take two pills and call me in the morning'' may be
appropriate for many people, but what works for the majority of the
population may not be effective, and could even be dangerous, for some.
The program we have initiated plans to systematically collect and
interpret information about the inherited variations in humans that
result in poor responses to drugs. The scientists we will support will
coordinate their activities in a research network so that the results
obtained can be maximally useful, and all will deposit their results in
a shared repository. This effort will be conducted in collaboration
with the National Heart, Lung, and Blood Institute; the National Human
Genome Research Institute; the National Institute of Environmental
Health Sciences; the National Institute of Mental Health; and the
National Institute on Alcohol Abuse and Alcoholism.
As part of the pharmacogenetics initiative, we assembled an
advisory group in May of 1999 to consider possible areas of
misunderstanding and the ramifications of future research in
pharmacogenetics. Since many identifiable differences in the response
to drugs have emerged from studies of populations, it is necessary to
consider issues of stereotyping and stigmatization of communities, and
the possible resulting harm to individuals, such as discrimination in
access to various social benefits, that might arise from membership in
an identified group. The members of the advisory group, as well as
participants in several follow-up focus groups, felt that the possible
benefits of the pharmacogenetic research efforts outweighed the risks.
However, they recommended that we provide a clear statement to the
public of the goals of the research and the issues involved, and that
we ensure that we have appropriate mechanisms in place to maintain
privacy and confidentiality.
A second major effort is the Protein Structure Initiative, which
attempts to use the information developed by the Human Genome Project
and other genomic programs to identify the structures of all the
proteins in nature. The benefits of understanding three-dimensional
protein structure have been demonstrated many times. Applications
include drug design and understanding of the molecular basis of
disease. It is certain that a complete catalog of structures and their
relation to function would provide insights into the operation and
integration of biological systems that we cannot now fully comprehend.
However, such an experimental effort directed at solving the structure
of every protein in nature is not feasible. It would take decades and
be extremely expensive. Fortunately, there is a shorter route to this
goal. Proteins appear to fall into ``families'' of related structures.
If the detailed structure of one or a few members of each family is
known, it is possible to infer the structures of the other family
members.
We have mounted a program, beginning in fiscal year 2000, to test
approaches to identifying appropriate protein family targets, as well
as to develop high-speed procedures to determine structures. Grant
recipients will be asked to operate as an interactive team, sharing
information about progress on a regular basis and depositing data in a
shared repository to ensure there is no duplication of effort. This
will be integrated with other such programs around the world. To this
end, an international meeting to ensure coordination and collaboration
is planned for the spring of 2000.
The last initiative I would like to describe attempts to address
major problems in biomedical research by facilitating the collaboration
of large groups of investigators. Although awards to individual
investigators are the mainstay of our support for research, it has
become clear that to put all the information together to understand how
biological systems operate, something more may be required. We are
attempting to provide that additional support through an approach which
we term ``glue grants.'' This is because we will supply the ``glue''
that will catalyze the interactions between already funded
investigators to aim at problems that they could not pursue
individually. In general, the glue grants will support large-scale,
interdisciplinary approaches to significant biological problems by
providing the resources for such items as core facilities, database
development, and electronic media for effective collaboration. This
approach is itself an experiment in the organization of scientific
effort. It should provide one opportunity to see how the flood of
information coming from individual laboratories can be integrated and
amplified to address important problems of biology.
Finally, a major goal of the NIGMS is to establish programs that
will result in a cadre of highly qualified researchers. This requires
developing flexible training mechanisms that reflect the rapidly
changing needs of science, as well as providing cross-disciplinary
training. The NIGMS predoctoral training programs remain a benchmark
for graduate training, and have evolved to incorporate new areas as
science developed. Most recently, we have initiated a training program
in bioinformatics--the field at the interface of biology and computer
science--to address this emerging area. Bioinformatics is increasingly
needed to manage and mine the vast quantities of data that biomedical
scientists are generating.
Similarly, we have expanded our programs targeting underrepresented
minorities to ensure that future demands for scientific personnel will
be met. We have developed new programs to enhance the research
environment at minority-serving institutions; to support computer
infrastructure via supplements to existing grants; to provide technical
assistance in grant writing; and to combine a traditional postdoctoral
experience with an opportunity to develop teaching skills through
mentored assignments at minority-serving institutions. At the same
time, the average size of individual research budgets in our Minority
Biomedical Research Support (MBRS) programs has doubled over the last 3
years, while the number of students supported in these programs has
increased by 60 percent. We anticipate our increased investments to
show real benefits in an increasing number of minority students going
into biomedical research, and we are developing evaluation procedures
to track the outcomes of our efforts.
We are particularly pleased with the results of the Bridges to the
Future Program, which is cofunded by NIGMS and the NIH Office of
Research on Minority Health. The results indicate that students in the
program make the transition from 2-year to 4-year institutions and
receive bachelor's degrees at a rate of about twice the national
average. Although the part of the program that supports the transition
from a master's degree to a Ph.D. has as yet only small numbers, the
data available also suggest that the transfer rate of these students to
Ph.D.-granting programs is also about twice the national average.
In conclusion, NIGMS remains dedicated to developing approaches to
ensure that biomedical research continues to progress. The resources
that we have received will permit us to take advantage of the rapidly
expanding opportunities in science.
Thank you, Mr. Chairman. I would be pleased to answer any questions
that you may have.
______
Prepared Statement of Dr. Duane Alexander
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2001 President's budget request for the National
Institute of Child Health and Human Development (NICHD). The request of
$810.5 million reflects an increase of $40.8 million over the
comparable fiscal year 2000 appropriation. Including the estimated
allocation for AIDS research, total support requested for NICHD is
$904.7 million, an increase of $45.4 million over the fiscal year 2000
appropriation. Funds for the NICHD efforts in AIDS research are
included within the Office of AIDS Research budget request.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
The NICHD seeks to assure that every individual is born healthy and
wanted, that women suffer no adverse consequence from the reproductive
process, and that all children have the opportunity to fulfill their
potential for a healthy and productive life unhampered by disease or
disability. In pursuit of this mission, the NICHD conducts and supports
laboratory, clinical, and epidemiological research on the reproductive,
neurobiologic, developmental, and behavioral processes that determine
and maintain the health of children, adults, families, and populations.
MENTAL RETARDATION
Since this Institute was established 37 years ago, a major portion
of our research has been devoted to better understanding the causes,
treatments, and prevention of mental retardation. One by one, in large
part as a result of the support for research from this Committee,
causes of mental retardation are being eliminated:
--phenylketonuria or PKU--eliminated;
--congenital hypothyroidism--eliminated;
--hemophilus influenzae type b meningitis or Hib--eliminated;
--measles encephalitis--nearly eliminated;
--congenital rubella syndrome--nearly eliminated;
--bilirubin encephalopathy--nearly eliminated.
Our progress toward understanding and eliminating the causes of
mental retardation has continued during the last year. In a highly
significant advance, Dr. Huda Zoghbi, an NICHD grantee in our Mental
Retardation Research Center at Baylor, identified the gene responsible
for Rett Syndrome, a mysterious condition that causes seemingly normal
infant girls to lose their ability to walk and to develop symptoms of
severe mental retardation. After years of exploration, researchers
discovered the genetic difference between girls with Rett Syndrome and
unaffected children. Girls with Rett Syndrome have a defective gene on
one of their two X chromosomes. These girls have some normally
functioning copies of the gene, so their symptoms are not immediately
apparent at birth. However, between 6 and 18 months of age, these girls
begin to exhibit the symptoms of Rett Syndrome when the function of the
normal single gene is insufficient to meet the growing child's needs.
[This discovery also sheds light on why only females are affected by
the syndrome. Males with the Rett Syndrome gene possess only the mutant
version of the gene because they have only one X chromosome.
Presumably, male fetuses with the gene for Rett Syndrome die before
birth or soon thereafter because they do not have a back-up copy of the
normal gene.] The gene that is abnormal in Rett syndrome, called MECP
2, controls the function of several other genes, so when it is
defective, multiple other genes, including some that are essential for
brain development and function, operate improperly. Based on this
exciting discovery, the NICHD is encouraging investigators to try to
find pharmacologic agents that can substitute for the control
mechanism, and thereby reverse or prevent the progression of Rett
Syndrome.
Another significant finding we reported this year may provide a way
to reduce the risk of mental retardation for children born to women who
have hypothyroidism during their pregnancy. We have known for many
years that congenital hypothyroidism in children is associated with a
lower IQ and we have eliminated that problem by screening all newborn
infants. Now NICHD research has demonstrated that children born to
mothers who have untreated hypothyroidism during pregnancy scored lower
on IQ tests than children of healthy mothers, with 19 percent in the
borderline or retarded range. However, when mothers with hypothyroidism
were being treated for the condition, their children's IQ scores were
virtually identical to those of children born to healthy mothers. This
study suggests that screening women for hypothyroidism before or early
in pregnancy may provide a way to prevent mental retardation. A
protocol is in preparation to test this possibility in the 14 ob-gyn
departments that are part of the NICHD Maternal-Fetal Medicine Network.
This network is also studying ways to reduce the incidence of low birth
weight, another significant cause of mental retardation.
NICHD has also provided important testing for a proposed new
treatment of autism. In recent months a number of reports suggested a
potential benefit to using secretin in the treatment of autistic
children. We were intensely interested in these reports, but they
contained no scientific data to assess the degree or duration of
potential benefits. For this reason, NICHD launched a series of
placebo-controlled studies to investigate potential benefits and risks
of using secretin to treat autism. In results from the first of these
studies, NICHD researchers found that treatment with the synthetic
version of secretin offered no more benefit for children with autism
than did treatment with placebo. Additional studies will seek to
determine if secretin may be effective when given at various doses or
on more than one occasion. We are also investigating whether secretin
benefits autistic children with a particular group of symptoms and
whether biological secretin is more effective than the synthetic
version.
HEALTH DISPARITIES
Another area in which the NICHD has both a deep concern and a deep
commitment is the elimination of health disparities among minority
populations. The Institute is developing a comprehensive and
coordinated research plan for eliminating health disparities among
racial and ethnic minorities. Our plan will address infant mortality,
reproductive health, medical rehabilitation, and child and adolescent
health. I would like to highlight some of the initiatives which
illustrate our strong commitment to eliminating health disparities.
Over the last two years, the NICHD awarded funds to 20 departments
of obstetrics and gynecology to develop young investigators in the
field and prepare the next generation of principal investigators. We
also support 15 Reproductive Science Research Centers. In fiscal year
2001, the NICHD will enhance these programs by funding a program of
Specialized Centers for Research in Reproductive Medicine in Minority
Institutions that pairs minority institutions with established research
centers. The goal of this program is to increase the capacity of
minority institutions and investigators to conduct cutting-edge
research in the field of obstetrics and gynecology, focusing on
problems particularly prevalent among minorities.
The Institute's national Back to Sleep campaign, which urges
caretakers to place infants on their backs to sleep, has met with
significant success. In the five years since the campaign was launched,
deaths due to Sudden Infant Death Syndrome (SIDS) have dropped 38
percent. Despite this overall success, both the SIDS rate and the rate
of stomach sleeping among African-Americans remain more than double
that of white infants. To address this marked disparity, the NICHD
invited the leaders from a number of national African-American
organizations, as well as officials from Federal, state, and municipal
governments, to join us in developing and implementing strategies for
reducing SIDS in African-Americans. The group identified the need for
culturally sensitive materials and programs designed by and for
African-American communities. The NICHD is committed to carrying out
this strategy. As a first step, NICHD is conducting research with
African-American caretakers such as parents, grandparents, relatives,
and child care workers to identify more effective ways to communicate
the Back to Sleep message. One component is a transit ad, which will be
used first in the DC Metro system, and eventually in other cities
around the country. The Institute's goal is to eliminate the racial
disparity in infant back sleeping position within three years and
hopefully thereby eliminate the racial disparity in SIDS rates.
We are also exploring ways to improve reading skills in populations
of culturally and linguistically diverse students. Three years ago, the
NICHD began a reading instruction research program with nine DC public
schools. The purpose of the program was to determine whether applying
what we have learned in other reading programs could be applied
successfully with regular teachers in regular classrooms. Data from the
Early Intervention Project are still being collected and analyzed, but
preliminary data show a pattern of remarkable improvements in reading
ability. For instance, reading scores in schools that have historically
been at the 10th to 15th percentile have improved to better than the
50th percentile. Moreover, the entire class in intervention schools is
now performing at the national average. In a related area, the NICHD
and the Department of Education this year are jointly soliciting
research proposals for systematically studying the most effective ways
to teach reading English to children whose primary language is Spanish.
HIV RESEARCH
In previous years, I reported on the research that led to the
remarkable reduction in the rate of HIV transmission from mother to
infant during pregnancy and birth. NICHD and NIAID research have made
another important contribution to reducing maternal HIV transmission
this past year. Grantees discovered that the amount of HIV in a
pregnant woman's blood, known as maternal HIV viral load, is the prime
risk factor for transmitting the virus to the baby. By focusing
treatment on reducing the viral load during pregnancy, the risk of HIV
transmission from mother to infant can be further decreased.
In the developing world, where logistics and the cost of multiple
drug therapy for HIV are often prohibitive, research reported last year
showed that administering the antiviral drug nevirapine to the mother
just before delivery and to the infant just after birth can reduce HIV
transmission significantly. NICHD and NIAID are now conducting studies
to evaluate whether nevirapine, administered during the time a mother
is breast-feeding can reduce the rate of HIV transmission through
breast milk.
PEDIATRIC TRAUMA REHABILITATION
We also plan to expand research for children and teens in the area
of trauma. Injury is the leading cause of death for children five to 18
years old; violence is the third leading cause of death for this age
group. However, many clinical treatments for trauma are tailored
exclusively to adults and fail to consider the long-term effects of
these interventions on a developing child. The NICHD is planning a
multi-disciplinary, collaborative program to address this issue, led by
the Institute's National Center for Medical Rehabilitation Research.
This program will allow us to develop and assess therapies specifically
targeted to the physical, emotional, and social needs of children. As
part of this program, we will start a collaborative pediatric injury
and trauma clinical trials network. Concurrently, we will be examining
ways to actually prevent the risky behaviors that often result in
injury and trauma.
In 1998, the NICHD held a consensus conference on traumatic brain
injury or TBI. The panel identified specific concerns that require
further study regarding the impact of TBI on children. Brain injuries
can have a profound impact on new learning and future physical and
mental development of children. Based on the panel's recommendations,
the NICHD will establish specialized research programs on treatment
tailored directly to the needs of young children with traumatic brain
injury.
BEHAVIORAL RESEARCH
In the area of behavioral research, the Institute is identifying
some of the major influences on the health and health behavior choices
of young people. Since 1994, the Institute has supported The National
Longitudinal Study of Adolescent Health, also know as the Add Health
Study. The study has provided new insights into the ways that peers,
families, schools and neighborhoods can influence positive health
outcomes, as well as negative outcomes, such as violent behavior,
smoking, drinking, illegal drug use, and sexual behavior. Data from
this survey informed and will continue to inform public policy. With
the increased funding provided by this Committee in fiscal year 2000,
the Add Health study will collect additional data from the full
original cohort. This study will help identify the major determinants
of health and health behaviors during the transition from adolescence
to early adulthood.
Mr. Chairman, the support from this Committee for the research of
the National Institute of Child Health and Human Development has
contributed to the elimination and near elimination of some of the
major causes of childhood diseases and lifelong disabilities. We are
proud of this progress but we know we still face many daunting yet
exciting research challenges. In the years ahead, with your continued
support, I am confident that we will return to this room and report
back to you that we have eliminated some of the causes of learning
disabilities, that we have eliminated some of the causes of infant
mortality, that we have eliminated some of the life-long adverse
consequences of child-bearing, and that we have contributed in a
significant way to eliminating the health disparities that separate
racial and ethnic communities. I will be pleased to answer any
questions you have at this time.
______
Prepared Statement of Dr. Carl Kupfer
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Eye Institute
(NEI), for fiscal year 2001, a sum of $462.8M, which reflects an
increase of $23.6M over the comparable fiscal year 2000 appropriation.
Including the estimated allocation for AIDS, total support requested
for the NEI is $474M, an increase of $23.9M over the fiscal year 2000
appropriation. Funds for the NEI efforts in AIDS research are included
within the Office of AIDS Research budget request.
THIRTY YEARS OF ACCOMPLISHMENT
The NEI was formally established by Congress in 1968 and began full
operations in 1970. Significant progress has been made in the last 30
years in understanding and treating many diseases of the eye and visual
system, including:
--Developing highly effective treatments for severe diabetic
retinopathy, a potentially blinding disease that affects half
of the 16 million Americans with diabetes, according to the
NIH's Diabetes in America. Thirty years ago, half of those who
developed severe retinopathy were blind within five years of
diagnosis, according to the British Journal of Ophthalmology.
Today, because of NEI-sponsored clinical research, people with
advanced retinopathy have less than a five percent chance of
becoming blind when they get timely and appropriate treatment,
according to the Journal of the American Medical Association.
--Finding that Black and White individuals with advanced glaucoma may
respond differently to two surgical treatments for the disease,
with Blacks likely to respond more favorably to one treatment,
and Whites likely to respond more favorably to the other.
--Identifying a freezing treatment called cryotherapy that
significantly reduces vision loss from advanced cases of
retinopathy of prematurity, a potentially blinding visual
disorder affecting premature infants.
--Showing that rejuvenation of the immune system of people with AIDS
will prevent progression of a potentially blinding AIDS-related
eye complication called CMV retinitis.
--Developing two new medical therapies--latanoprost and dorzolamide--
for glaucoma. Both are given as eye drops.
--Finding that an antiviral drug--acyclovir--decreases the recurrence
of herpes infection of the eye, a very painful and potentially
blinding eye disorder.
--Identifying a gene that causes juvenile macular degeneration. This
finding may bring researchers closer to finding the cause of
age-related macular degeneration, a blinding eye disease
affecting about 1.7 million older Americans, according to the
NEI's Beaver Dam Study.
--Identifying several defective genes suspected of causing retinitis
pigmentosa, a group of inherited, blinding diseases that slowly
damage the retina and affect 100,000 Americans, according to
the American Journal of Ophthalmology. Identifying these genes
may lead to treatments that prevent nerve cell degeneration and
visual loss.
--Discovering a more effective treatment for optic neuritis, which
primarily affects women ages 15-45 and is often associated with
multiple sclerosis. This treatment--a combination of
intravenous and oral corticosteroids--restores vision more
rapidly and decreases relapses.
--Finding a simpler, more successful treatment of an infection of the
inside of the eye which, if left untreated or inadequately
treated, can cause loss of vision.
--Demonstrating that a surgical procedure thought to be beneficial in
treating an inflammation of the optic nerve is instead
potentially harmful.
--Developing a questionnaire to assess the impact of vision loss on a
person's quality of life. Called the Visual Function
Questionnaire, it is being used to evaluate the effectiveness
of new treatments being tested in clinical trials.
LOW VISION
NEI-supported researchers continue to focus on finding better ways
to prevent, treat, and hopefully cure diseases of the eye and visual
system. Despite these efforts, there are, according to The Lighthouse,
about 14 million Americans--one in 20--who have low vision due to eye
diseases and disorders of the visual system. We define low vision as a
visual impairment, not correctable by eyeglasses, contact lenses,
medicine, or surgery, that interferes with the ability to perform
everyday activities. As our population ages, it is expected that the
number of people with low vision will increase dramatically.
The impact of low vision on quality of life can be devastating. It
can lead to a loss of independence. It can affect people's ability to
move about safely, to make decisions, and to communicate with others.
It can lead to frustration and uncertainty with profound lifestyle and
economic consequences.
To bring the message that information and help are available to
people with low vision and their families, the NEI launched a Low
Vision Education Program last October. The goal of the Program is to
help improve the quality of life for people with low vision and outline
steps people can take to use their remaining vision more effectively. A
public awareness program that conveys positive, encouraging, and
uplifting messages will alert the public and health professionals to
this issue. People with low vision need to know that help exists, such
as visual rehabilitation services and devices. The eye care
professional should never tell his or her patient that nothing can be
done about low vision. The fact is something can be done about it.
As part of the program, we have introduced a Low Vision Traveling
Exhibit that increases public awareness about low vision and provides
important information for people who do not see well. This exhibit,
which will be displayed in shopping malls nationwide during the next
few years, is now debuting in Birmingham, Alabama. The exhibit features
an interactive CD-ROM touch screen program and provides first-person
stories of how Americans are living successfully with the condition.
The exhibit will help us reach those who need this information the
most--people with low vision and their families and caregivers.
The Low Vision Education Program is part of the National Eye Health
Education Program (NEHEP), the first Federally-funded eye health
education program. It is coordinated by the NEI in partnership with
close to 60 public and private organizations united behind a nationwide
effort to educate people about the importance of good eye health.
Through this network of ``grass roots'' organizations, the NEHEP
multiplies its efforts in educating the public.
As we launch the Low Vision Education Program, the National Eye
Institute is furthering progress in the area of low vision research,
and is currently supporting 26 grants at a cost of about $6 million.
Some of these projects involve laboratory research. Some involve
research to develop low vision devices and explore emerging
technologies. The auto focus binocular low-vision telescope has been
improved. Research has yielded several new methods of presenting
magnified text on computer screens. Another key advance is the
development of new technology, such as route planning database systems
and personal guidance systems, to improve way finding for people who
are visually impaired. The NEI is a full partner in the NIH's
bioengineering initiatives that bring together the necessary basic
science, engineering, and/or clinical expertise to focus on a
significant area of bioengineering research.
TRANSLATIONAL RESEARCH
Although the NEI is a clinically-oriented Institute, work performed
in the laboratory is a fundamental pillar of research on visual
impairment and blindness. It must be conducted before new therapies for
preventing or treating disease can be developed and tested in a
clinical trial setting. One of the greatest strengths of the NIH
intramural program is that laboratory research can be conducted, and
the findings quickly applied, to a small group of patients before
large-scale testing.
An excellent example of our ``lab-to-bedside'' research is the
discovery of a possible new treatment for uveitis, a severe eye
inflammation that affects children and young adults. The current
treatment for uveitis involves powerful drugs that can cause serious
side effects, such as decreased kidney function, cataracts, glaucoma,
and brittle bones. A collaboration between scientists at the NEI and
the National Cancer Institute will result in an alternative therapy,
called humanized anti-Tac monoclonal antibody, which can be given
intravenously once a month. This biological substance seems to control
uveitis as effectively as the standard treatment in this study, but
with a marked decrease in complications and side effects. This study
serves as a model for future studies.
VISUAL HEALTH DISPARITIES
The NEI is supporting a number of studies to improve understanding
of eye disease and visual impairment in traditionally underserved
populations. For example, among African Americans, glaucoma is the
leading cause of blindness. Results from NEI-funded studies confirm the
rates for blindness due to glaucoma in African-Americans are six times
higher than the rates for Whites. On the other hand, age-related
macular degeneration is rare for Blacks as compared to Whites.
Clinical Studies will help identify people at highest risk for
glaucoma and those most likely to benefit from early medical treatment.
To closely follow people who are at moderate risk of developing
glaucoma, the NEI is conducting a clinical trial called the Ocular
Hypertension Treatment Study. This multi-center clinical trial has
enrolled 1500 patients, of which 25 percent are African-American. The
high percentage of African Americans participating will enable analyses
of the effectiveness of topical medications in preventing the
development of glaucoma in Blacks.
Previous research has provided estimates of the prevalence of eye
disease among Whites and Blacks in the US, but no published comparable
data exists on the US Hispanic population. This paucity of data hampers
the design of appropriate eye health services. The NEI is now
supporting two large studies--The Los Angeles Latino Eye Study and the
Visual Impairment Among Hispanics in Arizona Study--that will help
direct manpower and resources toward the major eye health needs of the
Hispanic population.
The NEI is also conducting an investigation of eye development and
nearsightedness in schoolchildren. This study will compare and contrast
normal eye growth and development in Hispanic, African-American, and
Asian schoolchildren ages 6-14 years with what happens in Caucasian
children. With this information, we hope to be able to predict
nearsightedness in small children before it is clinically evident.
FUTURE DIRECTION OF VISION RESEARCH
There are eye diseases that have resisted our best efforts at
improving treatment. But the NEI is exploiting new advances in
molecular biology, genetics, immunology, cell biology, and other
disciplines to accelerate efforts to find cures for blinding diseases.
The NEI has outlined new therapeutic strategies--such as gene
replacement, tissue and cell transplantation, and growth factor
therapy--that show great potential. We can produce--and directly view--
abnormal blood vessels in the eyes of animal models. This allows us to
determine if various treatments for diabetic retinopathy and macular
degeneration are effective in eliminating these blood vessels, which
lead to blurred vision.
The vision researcher has the advantage of utilizing noninvasive
technology. Adaptive optics technology has recently been applied to the
visual system, giving the clearest views yet of the living retina
inside the eye. This may allow scientists to track the progression of a
number of retinal diseases such as retinitis pigmentosa and diabetic
retinopathy, and evaluate the efficacy of rescue of cell types in the
retina.
To help develop genomic resources that facilitate understanding of
the normal visual system and related disorders and diseases, NEI
sponsored a two-day multi-disciplinary functional genomic workshop last
September. The purpose of genetics studies related to the eye is not
only to identify eye genes, which will be aided greatly by NIH's Human
Genome Project, but also to determine what the genes do normally and
what happens when the genes are mutated. Some ideas generated at the
workshop included creating a visual system web site to enhance access
to existing, or newly created, databases for genes expressed in the
visual system; producing and characterizing expressed genes of the
visual system; and encouraging programs for genomics, functional
genomics, and disease. We have begun to implement many of these
suggestions.
Research will continue to examine all these possibilities, guided
by our goal of the past 30 years to improve the prevention, diagnosis,
and treatment of all diseases of the eye and visual disorders. Much
remains to be done. We understand that progress does not always occur
as quickly as we would hope. But we put ahead of us this goal and
vision for the new century. With the continued support of the American
people and the research priorities outlined in our strategic plan, we
will endeavor to protect this most precious sense of sight for all
Americans and all of humanity.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report,
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
Mr. Chairman, I will be happy to answer your questions.
______
Prepared Statement of Dr. Kenneth Olden
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for NIEHS for fiscal year 2001,
a sum of $460,971,000 which reflects an increase of $25,824,000 over
the comparable fiscal year 2000 appropriation. Including the estimated
allocation for AIDS, total support requested for NIEHS is $468,649,000
an increase of $25,961,000 over the fiscal year 2000 appropriation.
Funds for the NIEHS efforts in AIDS research are included within the
Office of AIDS Research budget request.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, this data will help identify new strategies
and objectives to improve programs across NIH and the Department.
There is a paucity of information to make important environmental
health regulatory decisions. When it's time for many of us to buy a car
or a house, we take great pains to study the market, examining factors
like reliability, safety and resale value, before committing ourselves
to make such a major investment. As a nation, however, we frequently
make decisions about how (or whether) to regulate chemical and physical
agents to improve environmental health--moves that cost the public and
private sectors hundreds of billions of dollars--without adequate
information. This lack of information is becoming more evident as we
move into an era when the biggest threats we face are from exposures to
low doses, not the high doses we have traditionally faced and tried to
control.
The most commonly used words in reference to environmental health
risks are ``not enough information.'' For example, a committee by the
National Research Council recently concluded that ``there is
insufficient research, and therefore insufficient evidence, to say
whether particular environmental contaminants known as endocrine
disruptors may be dangerous to humans.'' This information gap is not
unique to endocrine disruptors. Most experts agree that inadequate
information exists regarding the toxicity of chemicals, the variation
in susceptibility to toxic substances, the type, pattern, and magnitude
of human exposure to chemicals through the diet, the workplace, and the
environment.
In part, the current dilemma has resulted from the success of
environmental remediation and pollution control and reduction efforts
over the past 30 years. These efforts have dramatically reduced the
human health threats posed by the thousands of new chemicals and
technologies introduced into our environment. In fact, there are those
who argue the environment no longer represents a serious threat to
human health because the low-dose exposures currently experienced by
most Americans pose no significant health threat. But the assumption
that low-dose exposures do not present a potential health risk is
seriously flawed. We now know that chronic low-level exposures have the
capacity to accumulate and attain toxic concentrations in brain and
other tissues. For example, it is well documented that ingested
methylmercury can be completely absorbed from the digestive tract and
easily accumulate in the brain and poison the neurons involved in
learning and memory processes.
Managing today's risks will also require consideration of
biological concepts that were not part of the environmental health
science vernacular as recently as ten years ago. Concepts such as
susceptibility, environmental genomics, high-throughput screening and
transgenic technology were not among the priorities of the
environmental health research enterprise. We need to develop new
science, new technologies and new ways of conceptualizing and
investigating threats to human health. Environmental decisions of the
future will require better information and pollution prevention
strategies than currently exist today. New approaches are needed to
promote greater participation of local communities and public health
officials in environmental health research and policy development in
terms of priority setting and development of prevention strategies to
protect public health. Particular emphasis should be made to include
disadvantaged and minority populations in research and policy
determinations. These groups often bear the greater burden of
environmental hazards and, as has been clearly documented, suffer from
poorer health than do more affluent groups.
Realizing the public health and economic potential of environmental
health research requires a number of critical investments. I will focus
on three of them--high throughput technologies, susceptibility to
environmental toxicants, and exposure assessment.
HIGH THROUGHPUT TECHNOLOGIES
In my testimony before this Committee in 1997, I updated you on our
efforts to develop and validate high throughput technologies for
carcinogenicity and toxicity testing, including transgenic animal
models. Today, I am pleased to report that because of our leadership in
this area of research, transgenic animal models, as a tool to study
chemical carcinogenesis, is the subject of intense research. In fact, a
recent paper used one of these models to successfully assess chemical
carcinogenesis in vascular tissue. The hope is that such animal models
can be used in a carcinogenicity testing strategy, potentially reducing
our dependence on the conventional two-year rodent bioassay. The
transgenic bioassays use fewer animals, cost less, and take less time
because of their increased sensitivity to carcinogens and low incidence
of spontaneous tumors. While I am optimistic that transgenic animals
will be validated for assessment of carcinogenic or toxic potential of
chemicals, we have already initiated efforts to develop the second
generation of alternative test systems based on differential gene
expression. Given that gene expression is continuously modulated by
environmental cues, exposure to toxic agents can be expected to elicit
unique patterns of gene expression. Thus, DNA microarray technology,
which can monitor gene expression, could be a sensitive tool to assess
toxicity. The assumption is that toxic exposures are likely to evoke
quantitative and qualitative changes in gene expression. Therefore,
this technology should allow toxicologists to expose cells or tissues
to chemicals whose toxicity is unknown and match the results against
the ``signature,'' or common set of changes in gene expression,
produced by a known class of toxicants. This would reduce the need for
lengthy and expensive rodent bioassays (conventional and transgenic)
and would lend itself to testing at low doses and to automation. Today,
I want to announce our intent to establish a DNA Microarray Resource
Center to develop and distribute so-called ``Tox-Chips'' containing
candidate genes--genes known to be involved in cell growth and
proliferation and in the biotransformation of environmental carcinogens
or toxin--derived from human, mouse and other animal sources. This
approach to developing and applying this new technology to the field of
toxicology will ensure that all investigators will have access to this
expensive resource and that the products are the highest quality.
susceptibility to environmental toxicants
It is well known that most smokers do not develop lung cancer and
most women exposed in utero to diethylstilbestrol never develop vaginal
and cervical cancer. A common question asked of physicians is, ``Why
me, Doc?'' One answer to this question is that genetically-determined
differences in susceptibility are at least partly responsible.
Significant advances in our understanding of human genetics have
shown that specific genes play key roles in disease susceptibility. For
example, mutations in BRCA1, P53, XPB, and ATM are predisposing for
breast cancer, Li-Fraumeni syndrome, xeroderma pigmentosum, and ataxia
telangiectasia, respectively. Thus, it is reasonable to expect that
several of the genetic alterations in other genes will also have a
significant influence on disease susceptibility. With rapid advances in
cloning and sequencing of the human genome, it is now possible to
identify the genetic alterations responsible for differences in
susceptibility. The ``sequence'' of the entire human genome will be
elucidated within the next 12 months. However, the order of the bases
in the human genome is not one sequence but rather many variations of a
common theme. In fact, sequence variation is ubiquitous in human
populations; what differs is the frequencies of these variations.
Susceptibility also is influenced by the timing of exposure, the
gender and behavior of the individual, the nutritional state and
socioeconomic status. For example, exposure during rapid or critical
stages of development of the various organ systems such as embryonic
development, adolescence, puberty and old age, is likely to be an
important factor in disease development. We currently have little
information to guide decision-making with respect to these issues since
most toxicologic assessments have been done in adults, both animals and
humans, under otherwise optimal conditions.
To investigate the genetic basis for differences in predisposition
to disease, NIEHS extended the domain of genomic mapping and sequencing
to address the challenge of genetic diversity. The Environmental Genome
Project, initiated two years ago, seeks to identify genetic changes
that increase risk for disease development, and the results from these
studies will have profound implications for the practice of medicine
and environmental health risk assessment. The challenge will be to
create a repository of all common variants--a diversity map--and
correlate them with specific environmental exposures and disease
phenotypes through functional and epidemiologic studies.
Today, I am announcing our intent to support the development of
Comparative Mouse Genomics Centers that will make use of all available
DNA sequence variation data to produce novel transgenic and knockout
mouse models which will mirror specific variants of human
environmentally responsive genes found in the general population. The
Mouse Genomics Centers will bring together a team of investigators to
develop mouse models of environmentally relevant human diseases,
provide a comprehensive analysis of their phenotype and genotype, and
validate them for their use by the research community. The new models
produced by the Centers will then be used by the scientific community
to study diseases resulting from specific insults, including exposure
to environmental agents, viruses, nutritional factors, pharmacological
drugs, and other physical and chemical stresses.
It is important to emphasize that susceptibilities modify risk
rather than cause disease. This ``gene-hunt'' and ``mouse-model''
development exercise could have profound implications for risk
assessment in terms of setting standards for environmental exposures.
Data on the prevalence of susceptibility genes could take the guesswork
out of environmental decision-making with respect to susceptible
populations. These studies challenge a fundamental tenet of toxicology;
that is, that the dose makes the poison. We now know that it is the
host, plus the dose and the time of exposure, that makes the poison.
exposure assessment
Exposure monitoring is a ``right-to-know'' issue for citizens who
are involuntarily exposed to environmental pollutants. However, little
is known about actual human exposure and body burdens of environmental
pollutants. This knowledge gap hampers regulatory decision-making and
introduces uncertainties in setting exposure limits. It also limits our
capacity to develop effective prevention strategies. Exposure is
typically estimated using indirect surrogates of environmental quality
such as toxic release and production inventories and environmental
monitoring. Individual exposure, though, is highly variable and is a
function of individual uptake, metabolism, excretion and behavior. So
the assumption that everyone living in the same geographic area have
similar exposure is seriously flawed. What we need are direct measures
of exposure based on tissue analysis or deposition. Simple monitoring
of levels of chemicals in the environment does not necessarily reflect
amounts taken up and deposited in tissues.
Exposure assessment is emerging as a scientific field due to the
revolutionary advances in genetics, molecular imaging, molecular
biology, and microenvironmental and personal measurement technology. As
these technologies become more robust, sensitive and inexpensive, they
will provide the scientific foundation for the quantitative assessment
of human health risk. Exposure analysis provides the long-awaited
connection between toxicology and epidemiology, and will provide the
basis for hypothesis-driven research and examination of exposure-
disease relationships.
Several public health areas will benefit from improvements in
exposure assessment. The absence of adequate exposure data restricts
our ability to (1) evaluate low-dose effects of exposure to chemicals
encountered in the home, workplace and general environment, (2)
identify at-risk populations based on age (e.g., children), genetic
susceptibility and socioeconomic status, (3) design studies to
efficiently evaluate exposure/response relationships, (4) make full use
of the human genome effort for studying gene/environment interactions,
and (5) to link exposure to human diseases.
In September 1999, the NIEHS and the American Industrial Health
Council co-sponsored an interagency workshop on ``The Role of Human
Exposure Assessment in the Prevention of Human Disease.'' With more
than 400 participants, the three-day workshop represented experts from
the various federal agencies, public interest groups, academia, and
industry. Participants considered the workshop a landmark event in the
field of exposure assessment in that it provided the vision and
enthusiasm for moving the field of exposure assessment away from solely
an applied discipline to one in which hypothesis-driven research can
effectively connect technological advances to public health problems
and controversies. Since the workshop, NIEHS has developed a
collaborative relationship with the National Center for Health
Statistics and the U.S. Geological Survey to develop a population-based
geographical information system and disease prevalence maps.
In conclusion, the power of the science base for environmental
health decision-making can now be transformed at a pace that could not
have been foreseen a decade ago by even the most astute visionaries.
The scientific opportunities presented here develop an entirely new
framework to understand how environmental exposures affect human
health.
______
Prepared Statement of Dr. Richard J. Hodes
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Institute on
Aging (NIA) for fiscal year 2001, a sum of $721,651,000, which reflects
an increase of $37,933,000 over the comparable fiscal year 2000
appropriation. Including the estimated allocation for AIDS, total
support requested for the National Institute on Aging is $725,949,000,
an increase of $38,088,000 over the fiscal year 2000 appropriation.
Funds for NIA efforts in AIDS research are included within the Office
of AIDS Research budget request.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
Since the NIA's inception in 1974, tremendous strides have been
made in uncovering the mysteries of the aging process, reducing disease
and disability, and improving the quality of life for older Americans.
The pace of scientific discovery has been impressive, and the Institute
anticipates building upon these advances in the future. I am pleased to
report the NIA's recent progress, in reducing disability and extending
healthy active years of life for all Americans.
alzheimer's disease research
Alzheimer's disease (AD), the most common cause of dementia, is the
result of abnormal changes in the brain that lead to a devastating
decline in intellectual abilities and changes in behavior and
personality. Tragically, as many as four million Americans \1\ now
suffer from Alzheimer's disease--a number that threatens to increase
dramatically as the population of people most at risk for dementia,
those aged 85 and older, reaches almost 20 million by the middle of the
21st century.\2\ NIA, as the lead Federal agency responsible for
Alzheimer's disease research, recognizes the urgency of this looming
public health threat and is supporting basic, clinical, and behavioral
research to improve AD diagnosis, treatment, and patient care, and to
delay, and eventually prevent, the onset of this devastating disease.
Advances in our understanding of AD over the last 20 years have been
substantial, enabling the NIA to launch the Alzheimer's Disease
Prevention Initiative. In collaboration with other Federal agencies and
the private sector, the AD Prevention Initiative is invigorating
discovery of new treatments, risk and preventative factors, methods of
early detection and diagnosis; and strategies for improving patient
care and alleviating caregiver burdens. The initiative is also
accelerating movement of promising new treatments and prevention
strategies into clinical trials, and is improving understanding of
normal brain function.
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\1\ Small, GW, Rabine, Barry, PV, Barry, PP, et. al. Diagnosis and
Treatment of Alzheimer's Disease and Related Disorders. JAMA 16: 1363-
1371, 1997.
\2\ Bureau of the Census, Middle Series Projections, 1996.
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In 1999, the NIA launched the first large-scale AD prevention
clinical trial supported by the NIH, the Memory Impairment Study (MIS),
being conducted at more than 65 medical research institutions in North
America. In this trial, vitamin E, and donepezil (Aricept) will be
evaluated over a three-year period for their effectiveness in slowing
or stopping the conversion from mild cognitive impairment (MCI), a
condition characterized by a memory deficit without dementia, to AD.
Other ongoing or upcoming AD prevention trials will examine the
effectiveness of ibuprofen (an anti-inflammatory drug) in reducing the
development of AD; the effect of estrogen replacement therapy in
preventing AD in women with a family history of the disease; and
whether treatment with a variety of agents, such as aspirin, vitamin E,
antioxidants, or combined folate/B6/B12 supplementation can prevent AD.
The effects of these agents on normal age-related decline will also be
evaluated. Information about ongoing clinical trials is available to
the public through the NIA-supported Alzheimer's Disease Education and
Referral Center web site (www.alzheimers.org) and toll-free number (1-
800-438-4380).
The ability to assess the effectiveness of early treatments or
interventions, such as those being tested in the AD Prevention
Initiative, will be enhanced by our ability to visualize brain function
using new imaging techniques. In a recent study, investigators used
magnetic resonance imaging (MRI) to determine volume measurements of
the hippocampus, the region of the brain responsible for memory
function, in individuals diagnosed with mild cognitive impairment
(Chart #1). Based on three years of observations, researchers found
that in older people with MCI, the smaller the hippocampus at the
beginning of the study, the greater the risk of developing AD later.
This imaging study illustrates how abnormal cerebral function or
anatomy can be detected before clinical diagnosis and how diagnostic
advances can help ensure the effective application of emerging early
interventions. Advances in imaging techniques also have important
diagnostic implications for other neurodegenerative diseases, such as
Parkinson's disease.
Developing effective treatments for AD based on advances in basic
research is a major focus of NIA-supported studies. The ability of
researchers to conceptualize effective treatments was enhanced by the
discovery of two enzymes, beta and gamma secretase, that are involved
in the clipping of a normal cell surface protein to produce the amyloid
peptide that forms the senile plaques found in the brains of AD
patients (Chart #2). Identifying and understanding how these two
enzymes work will accelerate the development of interventions to block
their action and stop the development of AD plaques. NIA will also
support research to evaluate the potential of an immunization approach
recently developed by researchers in the private sector, which, in
mice, prevented the formation of amyloid plaques associated with AD.
A transgenic mouse strain that expresses a human tau gene and
develops AD-like tau tangles has been developed. This model will help
scientists understand how tau produces AD in the brain, and together
with other AD models, will move researchers closer to developing
effective preventive or treatment interventions. In another study,
researchers demonstrated that shrinkage and dysfunction of certain
brain cells that occur with age might be reversible. Researchers
inserted into skin cells a gene that makes human nerve growth factor
(NGF) and then injected the modified cells into the brains of
experimental animals. After three months, the older animals injected
with NGF-expressing cells had brains that resembled those of younger
animals. Such gene transfer approaches to recovering cellular function
could eventually have important implications for the treatment of AD
and other chronic age-related neurodegenerative disorders in humans.
biology of aging
Research on the biology of aging has led to a revolution in
understanding the cellular and molecular changes that occur with aging
and the abnormal changes that are risk factors for or accompany age-
related diseases. Further, research is revealing genetic and other
biologic factors associated with extended longevity in animal models,
contributing to the development of interventions to reduce or delay
age-related degenerative processes in humans. Presently, caloric
restriction is the only intervention known to slow the intrinsic rate
of aging in mammals. Rodents and other laboratory animals that are
given a diet that includes necessary nutrients, but 30 to 40 percent
fewer calories than in usual diets, live far beyond their normal life
spans and have reduced rates and later onset of diseases. A recent
study analyzed the gene expression profiles of cells from young and
from old mice on usual or calorically restricted diets. Of the 6,347
genes surveyed by new micro-array techniques, fewer than one percent
displayed a greater than twofold decrease in expression. Thus, the
aging process may be associated with changes in expression of a limited
subset of genes, rather than involving widespread changes in most
genes. It was further observed that caloric restriction completely or
partially suppressed age-associated alterations in expression of a
large proportion of genes. This type of molecular assessment of
mammalian aging will provide new tools to evaluate experimental
interventions for age-related conditions.
Over the last ten years, numerous genes have been implicated in
normal aging processes, in age-related pathologies and diseases, and in
determination of longevity in several species including humans (Chart
#3). Understanding the molecular genetics of aging and longevity is a
rapidly advancing field; recent research advances have greatly expanded
our knowledge of genes and biological pathways which play significant
roles in determining longevity and health span. Recent discoveries in
non-mammalian species including S. cerevisiae (yeast), C. elegans,
(roundworms), and D. melanogaster, (fruit flies), have identified
striking effects of mutations, either singly or in specific
combinations, on lifespan, increasing life spans 2 to 3 times longer
than those of (wild type) normally aged animals. These findings suggest
signaling and metabolic pathways that may be critical in determining
longevity. In addition, cross-species comparisons have identified
homologous (similar) genes in animals and in humans that have similar
or related functions. For example, mutations that double the life span
of C. elegans occur in genes that are homologous to genes associated
with insulin and glucose (sugar) metabolism in humans, and may
therefore be relevant to weight control and diabetes.
reducing disease and disability
Studies have shown that disability rates for people age 65 and
older have been falling at an accelerating pace since 1982 and that the
benefits of this trend extend to both men and women, and to minority
groups. Initial field reports from the 1999 wave of the National Long-
Term Care Survey indicate that disability rates have continued to fall.
These data parallel heartening news from investigators who found that
many centenarians remain functionally independent for the vast majority
of their lives. More research is needed to understand the genetic and
environmental factors responsible for centenarians' prolonged good
health and extreme longevity. Similarly, more research is necessary to
understand the causes and economic consequences of the decline in
disability rates and to further accelerate these improvements.
Increasingly, researchers are understanding the benefits of
exercise, especially for older people, as a key to preventing or
delaying the onset of disease and disability. Specifically, studies
have revealed that moderate physical activity can: reduce the risk of
falls; benefit people suffering from a variety of ailments, including
osteoarthritis and depression; and may enhance learning, memory and the
generation of brain cells. There is also scientific evidence that
exercise may be a factor related to increased life expectancy and the
number of years people live free of disability. In a recent study, it
was shown that becoming fit, even in later years (as measured by
performance on an exercise treadmill test), is associated with lower
mortality rates (Chart #4). The study, which included 9,000 men aged 20
to 82, compared death rates in physically unfit men who remained unfit
over five years with physically unfit men who became fit during the
same period. The study found that unfit men aged 60 and over who became
fit had death rates 50 percent lower than those who remained unfit. In
another clinical trial involving chronically ill older adults, aged 70
and older, researchers reported that one year of increased physical
activity, combined with chronic-illness self-management resulted in
fewer reported hospitalizations and total hospital days. These studies
show that exercise can benefit older people and that it is never too
late to start. The challenge remains to motivate more people to engage
in regular physical activity--particularly older women and minorities
who, according to national surveys, are consistently less active. Last
year, the National Institute on Aging published a free manual,
Exercise: A Guide from the National Institute on Aging, the cornerstone
of the Institute's ongoing campaign to encourage older people to
exercise. The Guide is based on scientific evidence and is intended to
help people design their own exercise program. To date, the Institute
has distributed over 230,000 copies.
reducing health disparities
Health disparities are associated with a broad, complex, and
interrelated array of factors, including race, ethnicity, gender,
socioeconomic status, age, education, occupation, and as yet unknown
lifetime and lifestyle differences. Prevalence rates of specific
diseases are also associated with race, ethnicity and socioeconomic
status. One recent multi-ethnic epidemiologic study indicated that
prevalence rates for Alzheimer's disease may be higher for African-
Americans and Hispanics. In an examination of genetic risk factors for
AD, although APOE4 is associated with higher risk of AD among
Caucasians, African Americans and Hispanic elders with the APOE4 allele
were not at higher risk than those with other APOE alleles.
Understanding the genetic and environmental risk factors contributing
to this difference will be crucial to developing effective
interventions to reducing the disparity.
NIA has made reducing health disparities a major priority of its
five-year strategic plan. Last year, with support from the NIH Office
of Research on Minority Health, the NIA intramural program designed a
mobile medical research vehicle to extend the opportunity to
participate in the Baltimore Longitudinal Study of Aging and in other
clinical research projects to minority and socioeconomically diverse
subjects. The NIA, working with the National Advisory Council on Aging,
also undertook a comprehensive review of its minority aging research
activities and training initiatives. The NIA is developing an
implementation plan to integrate the resulting recommendations into its
programs, such as the Resource Centers for Minority Aging Research,
which provide mentoring and training opportunities to individuals
interested in studying the health of minority elders, and the
Alzheimer's Disease Centers satellite clinics, which recruit minorities
for research protocols conducted by the NIA's 28 AD centers.
Investigators supported by the NIA continue to report exciting
scientific advances that may help eliminate health disparities among
groups of elders. Investigators recently published a study, which
suggests that there is a difference between African-American and
Caucasian women in their experience of peri-menopausal symptoms.
African-American women were significantly more likely than white women
(58 percent vs. 29 percent) to experience hot flashes, but fewer than 7
percent had discussed menopausal management with their physicians.
Given our developing understanding of hormone replacement therapy in
controlling menopausal symptoms as well as in reducing risk of problems
in later life, such as osteoporosis, improved, culturally-appropriate
patient education programs should be encouraged.
A decade ago, few interventions were available to address the major
health concerns of older people. Entering the 21st century, the outlook
has improved considerably. More interventions exist and research into
treating, as well as preventing, the onset of age-related diseases is
escalating. With the knowledge this research will derive, aging will be
a healthier, more vigorous stage of life. I am happy to answer your
questions.
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Prepared Statement of Dr. Stephen I. Katz
Mr. Chairman and Members of the Subcommittee: I am pleased to
present the President's non-AIDS budget request for the NIAMS for
fiscal year 2001, a sum of $363,479,000, which reflects an increase of
$19,021,000 over the comparable fiscal year 2000 appropriation.
Including the estimated allocation for AIDS, total support requested
for the NIAMS is $368,712,000, an increase of $19,232,000 over the
fiscal year 2000 appropriation. Funds for the NIAMS efforts in AIDS are
included within the Office of AIDS Research budget request.
I am honored to appear before this Subcommittee. I want to begin by
providing a context for the research mission of our Institute. As the
Director of the NIAMS, I am acutely aware that the every day life of
the American people is enormously improved by the research that our
Institute supports. Children on the playground, women and ethnic
minorities who are disproportionately afflicted by the many diseases
that affect their daily activities, adults in the work place, and
elderly Americans striving to live independently--all have their lives
enhanced or compromised by the health and functioning of their bones,
joints, muscle, and skin. Ensuring improved quality of life and
increased longevity of life for all Americans is our primary mission.
I want to express my appreciation for the fiscal year 2000
appropriation--the second year of an extraordinary budget that enabled
us to invest in medical research with much more breadth and depth than
ever before. I will share specific examples of ways in which we
invested our budget over the last year and some of the research
directions we are pursuing.
clinical research
The focus of most of my remarks today will be on clinical research.
While the backbone of medical science has been and will continue to be
fundamental research on how the body functions, the ultimate goal of
research supported by the NIH is improving public health. In order to
achieve this, we must also serve as translators--translating the basic
research findings from the laboratory to improving patient care at the
bedside as well as utilizing the information learned at the patient
bedside to inform more focused and sophisticated basic studies. This
translation is the cornerstone of the research supported by the NIAMS.
Highlights of particularly exciting and promising translational
research on bones, joints, muscles and skin include the findings that
lower doses of estrogen than we normally prescribe can be effective in
preventing osteoporosis, that some of the new treatments for rheumatoid
arthritis can be targeted directly at the disease-causing factors, that
normal hair growth is controlled by genes that encode for proteins that
may be excellent targets for new therapies, and that proteins that are
essential for normal muscle formation can, in mouse models, be produced
by injecting particular genes into the muscles that contain the
defective proteins. These examples provide only a broad sample of some
of the most recent findings from research studies that we have
supported.
The reality is that clinical research is vitally important, but is
also very costly. The significant increase in our appropriation last
year enabled us to launch a number of clinical initiatives in
particularly challenging areas of health, including: (1) Pilot studies
in rheumatic diseases and skin diseases--These studies include expanded
research on some of the most difficult public health challenges such as
leg ulcers, rheumatoid arthritis, scleroderma, lupus, spondylitis and
others where new treatment approaches are needed. (2) Osteoporosis in
men--A major clinical trial will determine the extent to which the risk
of fracture in men is related to bone mass and structure, biochemistry,
lifestyle, tendency to fall, and other factors. The study will also
seek to determine if bone mass can be correlated with an increased risk
of prostate cancer. (3) Combination therapies for osteoporosis--It is
important to determine whether combinations of drugs, often produced by
different pharmaceutical companies, will be more effective and have
fewer side effects than any of the drugs used alone for osteoporosis.
(4) Treatment of back pain--Back pain is very common and has a serious
impact on people's personal and professional lives, and results in
significant costs to businesses and the American economy. We have
launched a major clinical trial studying surgical versus nonsurgical
treatment of three different back disorders. We anticipate that this
study will have a significant effect on clinical practice and the cost
of medical services for people with any of these three back disorders.
(5) The Spondylitis Consortium--The NIAMS has partnered with the
American Spondylitis Association in establishing the North American
Spondylitis Consortium to search for genes that determine
susceptibility to ankylosing spondylitis, a painful inflammatory
disease of the spine, also known as arthritis of the spine. and (6)
Clinical research training and career development--Because we need to
develop and maintain a pipeline of researchers who are training to
plan, conduct, analyze, and disseminate the findings of clinical
research, the NIAMS has enthusiastically embraced and participated in
the NIH initiatives to develop and maintain careers in clinical
research.
autoimmunity
The NIAMS supports a broad and diverse portfolio of research on
autoimmunity, including studies of rheumatoid arthritis, systemic lupus
erythematosus, Sjogren's syndrome, scleroderma, alopecia areata, and
many blistering skin diseases--all potentially devastating chronic
diseases which exact a huge toll in human suffering and economic costs.
The additional funds provided by Congress for the Autoimmunity
Initiative last year provided the opportunity for the NIAMS to expand
its research in the following key areas: (1) pilot trials on innovative
therapies for rheumatoid arthritis and scleroderma; (2) target organ
damage in autoimmune diseases, also focusing on scleroderma and
rheumatoid arthritis; (3) autoimmune rat repository and transgenic
resource--a national resource and development center for rat models of
autoimmune disorders; (4) NIAMS patient data registries--in which
information will be collected on neonatal lupus and on juvenile
rheumatoid arthritis, with an expansion to include genetic studies; and
(5) new imaging technologies for autoimmune diseases, through a project
involving in vivo imaging of tiny blood vessels in animal models of
rheumatoid arthritis.
fibromyalgia
The NIAMS has a firm commitment to identifying the causes of
fibromyalgia and improving the daily life of people affected by this
debilitating disease, and we have a broad portfolio of research in this
area. Last year the NIAMS as well as the NIDCR, NINDS, and the ORWH
funded fifteen new clinical and basic research studies on fibromyalgia,
and we are confident that these new studies will provide much-needed
information on the causes of fibromyalgia as well as new strategies for
treatments.
muscle diseases
People affected by muscle diseases face profound changes and
challenges in their every day lives. We now know that many of these
diseases are caused by genetic mutations, and we are supporting
research to further define these mutations and to overcome the current
barriers to effective gene therapy of muscle diseases. We are
optimistic that genetic manipulation of skeletal muscle will improve
therapy for muscle diseases such as Duchenne muscular dystrophy and
Facioscapulohumeral dystrophy. The Institute, in collaboration with the
National Institute of Neurological Disorders and Stroke, is sponsoring
workshops in both of these areas in May 2000 and we are looking forward
to hearing recommendations from experts in these fields on research
directions we could pursue in fiscal year 2001.
osteoarthritis
As many Americans are well aware, osteoarthritis is the most common
disease of joints. The NIAMS continues to support a substantial amount
of research across the full spectrum of scientific approaches and
strategies to understand this disease and improve life for affected
people. In July 1999 we sponsored a major conference on osteoarthritis
with the participation of leading experts in this field and many
related fields. We used this opportunity to have a tandem educational
meeting for patients whose daily lives are affected by osteoarthritis.
We learned a great deal about the disease from both kinds of experts--
those doing research on osteoarthritis and those living with it. We are
carefully considering the recommendations made from both sets of
experts to strengthen our portfolio in osteoarthritis using the fiscal
year 2001 appropriation, particularly in the area of prevention. The
NIAMS is also partnering with our colleagues in the National Institute
on Aging, the Food and Drug Administration, many pharmaceutical
companies, and several professional and voluntary lay organizations to
try to create a public-private partnership to identify biomarkers for
osteoarthritis. Our goal is to support clinical and laboratory
evaluations of biomarkers and imaging techniques as potential surrogate
endpoints for clinical trials that would assess the efficacy of
osteoarthritis disease-modifying interventions.
osteoporosis
We have known for some time that osteoporosis has genetic
components, but the genes that are actually associated with fractures
themselves had not previously been identified. Scientists have found
that older women who have the gene for apolipoprotein E, also known as
APOE*4, are at increased risk for hip and wrist fractures. We know
about this gene from other studies of its association with common,
late-onset forms of Alzheimer's disease and with osteoporosis in
patients on dialysis. This represents a promising area for further
study in patients with osteoporosis as well as those with Alzheimer's
disease, who are known to have a higher risk of hip fracture.
In March 2000 the NIAMS and other NIH components will hold a
Consensus Development Conference on osteoporosis to address many key
questions and to bring a focus to scientific opportunities that could
be pursued in this major public health problem that compromises daily
activities for millions of Americans of all ages. The information that
comes from this Conference will be broadly disseminated to physicians
and other caregivers, as well as to the public.
systemic lupus erythematosus
In genetic studies of lupus, researchers have found an association
between the disease and a region on chromosome 1. Fine mapping of this
region has identified another candidate gene involved in immune
function. Studies of the genetics of lupus may identify potential
therapeutic targets and may facilitate the development of markers of
disease activity. While medical research has certainly made a
significant difference in the daily lives of people (primarily women)
with lupus, this remains a major public health problem that compromises
the quality and longevity of life for many Americans. In addition to
the many systems of the body that are affected, patients with lupus
also have a higher risk of neuropsychiatric manifestations and
accelerated atherosclerosis. In 1999 the NIAMS sponsored workshops in
both of these areas, and we intend to follow-up on the many excellent
recommendations from experts who participated in these two meetings.
skin diseases
Gene therapy has potential for treating many skin diseases,
diseases that significantly compromise daily life for millions of
Americans both physically and psychologically. In addition, skin can
also serve as a factory for the production of molecules including
hormones such as insulin and human growth hormone that are used in the
treatment of many systemic diseases. Skin provides a number of
advantages for gene therapy approaches, including the ability to remove
genetically altered skin by simple excision if problems develop. The
NIAMS is supporting a scientific conference in March 2000 to increase
the level of interest in gene therapy using skin and to identify
scientific opportunities and needs in this area.
health disparities
While we know that disease can strike people at every age, of
either gender, and in every ethic group, we also know that many
diseases affect women and members of minority groups
disproportionately--both in increased numbers and increased severity of
the diseases. Even if variables such as socioeconomic status, access to
health care, and insurance coverage are eliminated, the fact remains
that diseases like lupus, scleroderma, osteoarthritis, and vitiligo all
account for disparities in the health of women and minorities. We are
actively seeking to understand the causes of these gender and ethnic
differences, and we are expanding our commitment to better
understanding of health disparities. We are also increasing our efforts
to disseminate health information to minority populations and have
established a toll-free line in both Spanish and English as well as
produced a number of our publications in Spanish. Plans are underway
for a workshop to address promising opportunities for research in this
area. In addition, members of our Intramural Research Program are
designing an outreach program targeted toward the minority community.
While it is still in preliminary stages, it will ultimately include
both local and national outreach efforts.
conclusion
Bones, joints, muscles, and skin are central components of the
human body. When the functions of any of these areas are affected, the
daily lives of people are compromised. We are committed to continuing
to support basic research as well as the many clinical studies
underway, including those exploring the roles of genetics, the
environment, diet, and behavior in disease. I cite our scientific
achievements with pride, and I pledge to continue my commitment to
support high quality science that will continue to improve the health
of the American people.
The NIH budget request includes the performance information
required by the Government Performance Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
I will be happy to answer any questions you 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 non-AIDS budget for the National Institute on Deafness
and Other Communication Disorders (NIDCD) for fiscal year 2001, a sum
of $276.4 million, which reflects an increase of $14.3 million over the
comparable fiscal year 2000 appropriation. Including the estimated
allocation for AIDS, total support requested for NIDCD is $278 million,
an increase of $14.3 million over the fiscal year 2000 appropriation.
Funds for the NIDCD efforts in AIDS research are included within the
Office of AIDS Research budget request. Within the last year, we have
witnessed outstanding research progress in human communication and
communication disorders by NIDCD-supported scientists and clinicians,
progress further accelerated by the efforts of other NIH institutes.
development
How Inner Ear Hair Cells Grow.--In humans, auditory sensory cells
(hair cells) and other internal parts of the ears develop within the
third month of development. These fragile, highly specialized cells,
which are essential for the hearing process, are often damaged or lost
as a consequence of noise, genetic mutation, drugs or other
environmental insults. The resulting hearing impairment is permanent,
since these cells do not regenerate in humans. NIDCD-supported
scientists are examining the cellular and molecular processes that
direct progenitor cells to differentiate into hair cells, leading to
new approaches to stimulate hair cell regeneration after damage. These
investigators have shown that in the mouse, the Math1 gene is essential
for regulating the development of hair cells and progenitor cells.
These findings provide novel insight into the molecular mechanisms
regulating hair cell differentiation and specification.
infancy and childhood
Better Procedures to Screen Infants for Hearing Impairment.--The
American Speech-Language-Hearing Association estimates that as many as
12,000 infants each year in the U.S. are born with significant hearing
loss, making it a common congenital disorder. Research supported by
NIDCD has shown that detection of hearing impairment and intervention
within the first six months after birth is very important for
optimizing language development in young children. In a five-year,
multi-center study, NIDCD-supported scientists determined the optimal
test procedures for neonatal hearing screening. This study was the
first controlled comparison of normal hearing and hearing-impaired
infants evaluating physiological responses to sound. The development of
precise and timely diagnostic screening techniques for hearing
impairment is the first step in providing early intervention strategies
that will optimize the development of either spoken or signed language
skills. The NIDCD is supporting research to develop and validate
intervention strategies that are tailored to the individual with
hearing impairment.
Hereditary Hearing Impairment--Gene Discovery and Implications.--
Not only is hearing screening becoming available to all newborns,
breakthroughs in medical genetics will enable scientists to identify
the precise genetic change leading to hereditary hearing impairment.
NIDCD-supported scientists have learned that about one-third of all
recessive hereditary hearing impairment within the U.S. is caused by
mutations in the GJB2 gene. But further studies have shown that there
is significant variation in the degree and time-of-onset of hearing
impairment among individuals with exactly the same mutation in both
GJB2 genes. Given this variation, it would be difficult to predict
onset and degree of impairment in these infants using only data from a
GJB2 genetic test. The NIDCD is interested in pursuing areas of
research to develop and validate diagnostic genetic tests, to assess
the potential impact of genetic testing and the utilization of genetic
information on attitudes and behaviors of various cultural groups and
individuals.
Otitis Media--Vaccine Development and Genetic Susceptibility.--In
an NIDCD-supported study, scientists have discovered that there is a
strong heritable component to prolonged time with and recurrent
episodes of otitis media (middle ear infection) in children. The
results of this study may have future implications for primary care
physicians to identify children and siblings at high risk for otitis
media for careful monitoring and early intervention. In addition, with
the recent emergence of antibiotic resistant bacterial isolates, it is
clear that the best long-term strategy for otitis media is prevention.
NIDCD scientists have developed a detoxified lipooligosaccharide-
protein conjugate to be used as a possible vaccine against nontypable
Haemophilus influenzae, a leading cause of otitis media in children for
which there is no vaccine currently available. A Phase I clinical study
is nearing completion in adult volunteers to evaluate the safety and
potential efficacy of the investigational vaccine. Preliminary data
from this study show that the vaccine is able to elicit the production
of specific antibodies against the bacteria in a number of volunteer
subjects. The results of this trial suggest that this investigational
vaccine may be useful for preventing otitis media in children.
Cochlear Implants May Improve Language Achievement in Children.--
The cochlear implant is an array of electrodes that converts sound into
electrical impulses that stimulate the acoustic nerve, restoring the
perception of sound. It is the only neural prosthesis in widespread
clinical use with over 20,000 recipients, about one-half of whom are
children. Scientists supported by the NIDCD conducted a study to
measure language achievement in children with cochlear implants. The
study, comparing a group of children who had received cochlear implants
and a second group who were using hearing aids, showed significant
differences in language achievement levels favoring the children using
cochlear implants.
Improved Methods for Diagnosing Early Childhood Stuttering.--
Stuttering is a disorder that typically begins between the ages of 2
and 5. When it persists, the disorder causes serious impairment in
verbal communication that is often associated with significant
difficulties in emotional and social adjustments. NIDCD is supporting a
large-scale longitudinal investigation of children who stutter to
examine various aspects of stuttering as it persists or subsides during
childhood. In addition, the study is identifying risk factors that can
help differentiate between children who develop persistent stuttering
and those who tend to recover. The data reveal a strong genetic
component to stuttering and differences in genetic liability between
different subsets of children who stutter. Based on these findings,
NIDCD-supported investigators have initiated a genetic association
study to map and identify the genes that predispose individuals to
stutter.
Defining and Identifying Specific Language Impairment in
Children.--Specific Language Impairment (SLI) is a language disability
observed in the absence of any other cognitive disorders, affecting as
many as 8 percent of all kindergarten-age children. Research to
understand and treat SLI has been hampered by the lack of uniformity in
the definitions and measures that are used to identify preschool-aged
and older children, adolescents or adults with SLI. NIDCD-supported
researchers have developed definitional guidelines and research
directions that will lead to enhanced abilities to diagnose and assess
SLI, determining that a brief non-word repetition task is a powerful
predictor of SLI. This test differentiates between children who will
benefit from language intervention and children who will not require
intervention to achieve normal language skills.
Eliminating Health Disparities in Hearing and Language Disorders.--
As research moves forward to reduce the burden of disease in America,
the NIDCD is committed to the idea that all segments of American people
should benefit from this progress. In comparison to the general U.S.
population, Native American children have one of the highest rates of
otitis media. The NIDCD is continuing its support of a study on the
epidemiology of this disorder and hearing loss among Native American
infants, from birth to age two, at the White Earth Reservation in
Minnesota. Recent assessment shows that intervention programs should
focus on parental smoking as a significant risk factor for otitis media
in Native American infants. The study also includes the development and
implementation of prevention strategies to reduce the burden of otitis
media such as promoting breastfeeding.
Treatment for Deafness Caused by Neurofibromatosis Type 2.--The
NIDCD is conducting research on neurofibromatosis type 2 (NF2), a
genetic disorder that often results in bilateral tumors of the acoustic
nerves causing deafness in children and adults. Scientists supported by
the NIDCD have determined that specific mutations in the NF2 gene
result in different levels of severity of the disease. This finding
will facilitate early DNA-based diagnoses that will improve disease
management and increase the preservation of hearing in NF2 patients.
For many individuals with NF2, surgical intervention required to remove
tumors also involves resection of both acoustic nerves, so that sound
perception cannot be restored with cochlear implantation. To help these
individuals, NIDCD is supporting research to develop a specialized
auditory prosthesis for NF2 patients. Multiple, ultraminiature
microelectrodes have been implanted directly into the ventral cochlear
nucleus of animals, the portion of the central auditory system where
the acoustic nerve fibers once made connections. These animal studies
have demonstrated the safety of this technique and deaf NF2 patients
are now scheduled to be fitted with these devices within the next few
years with the hope of restoring auditory perception.
adulthood
The Hazards of Noise-Induced Hearing Loss.--When an individual is
exposed to sounds that are too loud, the hair cells needed to detect
sound in the inner ear can be damaged, resulting in noise-induced
hearing loss (NIHL). NIHL is a major health concern, but it is
preventable. In a public outreach effort, the NIDCD has launched the
``WISE EARS!'' campaign, where a national coalition of over 60
government agencies, public organizations, businesses, industries and
unions is working to inform the public about the risk of NIHL.
Molecular Mechanisms Governing Our Sense of Taste.--In humans, the
loss of taste sensation can contribute to the loss of appetite and poor
nutrition, a particularly common problem for older Americans. In a
collaborative effort joining molecular biologists supported by the
National Institute of Dental and Craniofacial Research, NIDCD, and
investigators at the University of California, San Diego, candidate
sweet and bitter taste receptors have been cloned and characterized.
These receptors are selectively expressed in a non-overlapping subset
of taste receptor cells on the tongue. This research is an important
step in determining the molecular pathway activated by sweet and bitter
substances, and will guide future research studies in identifying
additional molecules in this poorly understood pathway.
Genetic Association and Age-Related Causes for Hearing Loss.--A
recent NIDCD-supported study has demonstrated that a genetic component
exists for age-related hearing loss. It is likely that different
mutations in the same genes that cause profound hereditary hearing
impairment in children also cause age-related hearing loss
(presbycusis), a common problem for older Americans. With the ability
to predict who is at increased risk, better strategies to minimize or
delay hearing loss within the aging population can be developed.
NIDCD/Department of Veterans Affairs Hearing Aid Clinical Trial
Yields Important Results.--The prevalence for hearing impairment
significantly increases with age and hearing aids are the most common
means of assistance for persons with hearing loss. The Department of
Veterans Affairs and the NIDCD conducted a multi-center trial, which
included elderly volunteers, to compare the efficacy of three commonly
used hearing aid circuits. Data from the trial showed that performance
differences among the three hearing aid circuits were minimal. Of
greater importance, the trial demonstrated that each circuit improved
speech recognition with improvement observed under both quiet and noisy
listening conditions. NIDCD remains committed to support research
leading to smaller and better hearing aids, capitalizing on
bioengineering advances in microelectronics.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Steven E. Hyman
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 2001, a sum of $896,059,000, an increase
of $50,083,000 (or 5.9 percent) above the comparable fiscal year 2000
appropriation. Including the estimated allocation for AIDS, total
support requested for NIMH is $1,031,353,000, an increase of
$56,680,000 over the fiscal year 2000 appropriation. Funds for the NIMH
efforts in AIDS research are included in the Office of AIDS Research
budget request.
areas of new investment
This has been a remarkable year for the NIMH, both in our
development of scientific programs and in our ability to contribute to
public understanding of mental illness. Thanks to a healthy increase in
our budget, we expanded our new Translational Centers program, which
aims to bring basic science as rapidly as possible into the clinical
arena. We built on our investment in studies of genetic risk factors
for schizophrenia, manic depressive illness, and early onset major
depression, with particular emphasis on expanding our gene repository
for research on autism. We initiated two major clinical trials, one on
best use of new antipsychotic drugs and one on the treatment of
individuals with depression who do not benefit from standard, initial
treatments. We reported the findings of a multi-site collaborative
study on treatment of attention deficit hyperactivity disorder, a
public health problem of immense concern to parents, teachers, and
health care providers, and we have initiated epidemiologic studies that
will enable us to address disparities in mental health treatment
outcomes with ever greater effectiveness.
heightened public awareness of mental illness
Growing recognition that mental illnesses are real diseases of an
organ, the brain; that they are diagnosable and treatable; that they
represent an enormous public health burden--for example, depression is
the leading cause of disability in the United States; and that current
treatments can have an enormous impact on diminishing that burden
spurred several important public education efforts in 1999. These
included the White House Conference on Mental Health and Mental
Illness, and the Surgeon General's Report on Mental Health, the first-
ever on this topic. Responding to a report from the National Center for
Health Statistics that 31,000 Americans committed suicide in 1996, more
than half again the approximately 20,000 U.S. homicides that year, the
Surgeon General issued a Call to Action to Prevent Suicide, which now
is the ninth leading cause of death in the U.S. and, as the Centers for
Disease Control reports, the third-leading cause of death among 15 to
24 year old Americans. NIMH has been privileged to play a critical role
in providing scientific data and educational materials for all three of
these activities.
We have come far in the science of mental illness and mental
health, but we still have much to learn. We are thankful that the
generous support of the American people, through the Congress, has made
it possible to attack difficult problems at many levels. Perhaps most
critical to our long-term goals of curing--and ultimately preventing--
serious and disabling diseases like autism, schizophrenia, manic
depressive illness, depression, anxiety disorders, and eating
disorders, is our enhanced ability to expand long-term investments
aimed at understanding the fundamental organization of brain and
behavior. This is a time of remarkable progress in molecular and
cellular biology, systems-level neurobiology, and cognitive
neuroscience, and a time of unparalleled opportunity afforded by
technologies ranging from gene chips to noninvasive neuroimaging. As
our basic science matures, we have initiated programs aimed at speeding
and enhancing the translation of that basic science into clinical
applications.
centers for translational science
What do I mean by ``translational science?'' Let me describe
briefly how several projects at one Center link basic and clinical
research. Collaborating scientists at the University of Pittsburgh and
Carnegie Mellon University are testing a hypothesis that certain
abnormalities in thinking (or cognition) that are characteristic of
schizophrenia reflect an impairment of functions in a particular brain
region, the dorsal lateral prefrontal cortex. This disorder typically
strikes in the late teen years or early twenties--just when families
and, indeed, society are completing their investment in the education
of a young person. Thus, this project is examining in animal models and
in clinical research how the brain's circuitry changes over the course
of development and, particularly during adolescence. Since both genes
and environment influence brain development, one component of this
study uses new gene chip technologies to examine how genes influence
the circuitry of the prefrontal cortex; using the new chip technology,
the investigator can determine which genes have been active and which
have been suppressed in the post-mortem brains of patients with
schizophrenia compared with normal controls; a similar gene analysis is
being done with adolescent monkeys. Other facets of the project involve
studies of a neurotransmitter, dopamine, that plays a critical role in
memory functions served by the prefrontal cortex, and functional brain
imaging studies of patients with schizophrenia and controls, with the
aim of determining the extent to which cognitive abnormalities can be
ascribed to the effects of dopamine on frontal cortex. What's exciting
is that each of these discrete projects is addressing fundamental
biological questions, allowing investigators to relate findings
obtained from basic animal studies to clinical research with an
unprecedented degree of coordination. Given the awesome complexity of
the brain, we believe that team efforts like this have the best chance
of understanding what goes wrong in the brain in schizophrenia.
In another Translational Center, investigators are exploring the
relationship between fear and stress in animal models; a key aim is to
determine whether the effects of stress on fear circuits mimic changes
that occur in fear-related disorders in humans, such as post-traumatic
stress disorder, anxiety and panic disorders, and paranoid
schizophrenia. Investigators at NYU, Columbia University, and
Rockefeller University, are using an identical behavioral paradigm--
fear conditioning--to examine fear circuits from multiple perspectives,
in animal and human studies. One effort that will benefit immensely
from its interaction with other Center studies will follow up on
findings that acute and chronic stress inhibits neurogenesis--that is,
the generation of new neurons in the adult brain. This question has
extraordinary ramifications for understanding mental disorders and
refining treatments.
identifying vulnerability genes for mental disorders
We have greatly augmented our investment in the genetics of
schizophrenia, manic depressive illness, major depression, autism, and
other mental disorders. It is now certain that these disorders have a
genetic component, but solving the genetics and identifying disease
vulnerability genes is extremely difficult because vulnerability to
these disorders results from the effects of many genes, each
contributing relatively small and interactive effects, as opposed to an
illness, such as Huntington's disease, in which a single gene
contributes a large effect. However, as we have learned from other
central nervous system disorders, such as Alzheimer's disease, the
discovery of vulnerability genes can lead to the identification and
validation of exciting new targets for development of therapies. During
the coming year, all of our genetics efforts will be aided by the
sequencing of the human, mouse, and other animal model genomes and by
ongoing projects to investigate human genetic diversity, especially as
it might apply to disease risk.
treatment research on autism
Pending findings from the genetics studies that I mentioned, NIMH
remains deeply committed to improving treatments currently available
for autism, a brain disorder that affects between 1 to 2 of every 1,000
Americans, with often devastating, lifetime effects on thinking,
feeling, and social functioning--all uniquely human attributes. A
network of five NIMH-supported psychopharmacology research units are
evaluating drug treatments for autism, such as risperidone and
valproate. Among studies of psychosocial treatments in autism, we fund
two projects evaluating parent training interventions that are tailored
to the particular characteristics of child and family. Of course, we
participate in the NIH Autism Coordinating Committee.
new clinical effectiveness trials
During the last fiscal year, NIMH has initiated large-scale
clinical trials on the best use of new antipsychotic medications and
the treatment of individuals who failed to respond to initial
antidepressant treatments. Along with our ongoing trials in adolescent
depression and in bipolar disorder, which we initiated over the past
two years, this thrust represents a substantial recommitment to
clinical treatment studies for people with mental illness. These
particular studies represent a new frontier in clinical treatment
research because they will study truly representative samples of
individuals with mental disorders. That is, eligibility for
participating in these treatment studies no longer is limited to
rarified populations within academic health centers, but is open to
general populations in diverse health care settings. This new approach
requires NIMH take great care to observe appropriate stewardship of the
trials while our field develops the infrastructure and expertise to
conduct such trials. In future years, we hope to expand this program to
address such issues as depression in young children, and mood disorders
that co-occur with psychotic disorders. We are also interested in
cross-NIH collaborations to focus on co-occurring substance use
problems with mental disorders.
research on youth violence
As recognition grows that violence by young people represents a
public health problem, we are encouraging a new generation of studies
that will attend, particularly, to the relationships between mental
disorders and violence, including suicide. We know that anxiety
disorders, depression, or suicidal ideation often co-occur with
behavior problems, and that the combination of depression with conduct
problems may be a combustible mix. Also, youth with conduct problems
often exhibit inattention and impulsiveness, often coexisting with
hyperactivity. We are coordinating our research involving dissemination
of prevention and early intervention strategies with the Centers for
Disease Control and other federal agencies, including the departments
of Education and Justice. Finally, I am pleased to report that NIMH
will assume a lead role in developing a Surgeon General's report on the
topic of youth violence. Dr. Satcher and, indeed, all of us have been
gratified by the overwhelmingly positive response of the American
public to the Surgeon General's Report on Mental Health, and we believe
this follow-up report will be an effective and highly credible means of
educating the public about the interaction of mental disorders and
youth violence.
multi-modal treatment assessment of adhd
In December, NIMH and collaborating investigators reported findings
from the landmark Multi-Modal Treatment Assessment Study--the MTA
study--of attention deficit/hyperactivity disorder, a major public
health problem that affects 3-5 percent of school children. The
experiences of 600 children enrolled in the study revealed that
carefully monitored medication management, with monthly followup and
input from teachers, is more effective than intensive behavioral
treatment. For measures such as improved academic performance and
family relations, combining behavioral therapy and medication proved
effective and satisfying to parents and teachers and permitted somewhat
lower doses of medication. Among the important insights of the MTA
study was documentation of the extent of undertreatment or
inappropriate medication treatment in normal, community-based care.
research on health disparities
A primary goal of NIMH and NIH research is to ensure that advances
in treatment benefit all Americans, including racial and ethnic
minorities who experience significant disparities of outcomes with
respect to many illnesses. Within the past year, NIMH conducted the
first two of a projected series of State-wide conferences on mental
health needs and opportunities that permit us to hear, first-hand,
citizens' perspectives on health disparities. We initiated a large-
scale study of the epidemiology of mental disorders among African
Americans and plan on parallel studies to understand the epidemiology
of mental disorder in other minority groups. These studies will
complement a new, state-of-the-science epidemiologic study of mental
disorders in the broader population that will be funded under a 5-year,
$7.3 million dollar grant to investigators at Harvard University who
will survey a representative sample of 10,000 Americans ages 15 and
over. For several decades, NIMH has set the standard for modern mental
health epidemiologic research, and this new study will ensure that we
have data necessary to allocate resources and design policies in this
era of massive change in the U.S. health care system.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report,
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will support the
identification of strategies and objectives to improve programs across
the NIH and the Department.
NIMH is committed to a research portfolio that stretches from
molecules and genes to brain and behavior to clinical investigation to
health services research and economics. This research portfolio is
thriving thanks to the development of new scientific approaches ranging
from genomics to neuroimaging to new clinical trial designs. In
parallel, we have been able to renew our Institute structure and also
the vitality of our Intramural Research Program by a combination of
rigorous review and recruitment of outstanding scientists. I look
forward to this new millennium with humility about the scope of the
problems that we must address but great optimism about the ability of
our research community to meet the challenge.
I will be pleased to answer any questions.
______
Prepared Statement of Dr. Alan I. Leshner, Director, National Institute
on Drug Abuse
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Institute on
Drug Abuse (NIDA) for fiscal year 2001, a sum of $496.3 million, which
reflects an increase of $27.1 million over the comparable fiscal year
2000 appropriation. Including the estimated allocation for AIDS, total
support requested for NIDA is $725.5, million an increase of $38.1
million over the fiscal year 2000 appropriation. Funds for the NIDA
efforts in AIDS research are included within the Office of AIDS
Research budget request.
building on recent accomplishments
Thanks to the commitment of both the Administration and the
Congress, including particularly this Committee, NIDA has been able to
launch some truly significant activities in the past year. Perhaps the
most noteworthy undertaking has been establishing the foundation for a
vehicle that will increase dramatically the quality of drug addiction
treatment throughout this country. Last year, we promised to build a
National Drug Abuse Treatment Clinical Trials Network (CTN) to test and
disseminate new science-based addiction treatments in real life
settings. I am pleased to be able to tell you that we not only have
established the first five nodes of this Network, but are about to
begin implementing the first three protocols. Moreover, adding five
more nodes to this infrastructure this year will take the CTN one step
closer to becoming the truly national research and research
dissemination network that we know it can and should be. Under NIDA's
overall guidance, the CTN will foster partnerships between treatment
researchers and community-based treatment providers to move well-tested
science-based addiction treatments into use in diverse patient
settings.
We are also building other areas of our research portfolio to
better inform how this country approaches drug addiction, including
looking more closely at the role genetic factors may play in
determining the likelihood someone will become addicted to drugs. In
the same way we are making great progress in understanding how genetics
can predispose one to cancer, heart disease, or diabetes, drug abuse
researchers are making similar advances in the addiction arena as well.
By better understanding the factors determining an individual's
vulnerability to addiction, our treatment and prevention success rates
will dramatically improve.
The research community is committed to this endeavor. The response
to NIDA's ``Genetics of Drug Addiction Vulnerability'' Initiative has
been overwhelming. We were able to fund five new grants last year to
examine the role of genetics in nicotine, cocaine, and heroin
addiction, and we hope to support in the coming years some of the other
outstanding proposals we received in response to this initiative.
long-term neurobehavioral effects of drugs of abuse
Advances within NIDA's neuroscience research portfolio also
continue coming at an accelerated pace. Let me give you one example of
how far our science has come since last year's appropriations hearing.
You may recall that I showed you images of how drugs, such as
methamphetamine and MDMA (Ecstasy), produce long-lasting changes in
brain function, changes that persist even years after the individuals
stopped using the drugs. Researchers have now taken those research
findings one step further and have begun to unravel exactly how these
brain changes dramatically affect an individual's behavior.
For example, researchers studying the residual effects of
methamphetamine in users who were drug free for ten months before this
study began, found that they had significantly impaired motor and
memory function. When they were asked to complete a battery of tests
that examined working memory and reaction times, as well as verbal
memory skills, these former methamphetamine users did far worse than
non-drug-using individuals. Importantly, the researchers also found
that the impaired memory in the former users was clearly associated
with significant reductions in the functioning of the brain's dopamine
neurotransmitter systems, in this case the number of dopamine reuptake
transporters. And the study showed that the greater the degree of
transporter loss, the greater the memory deficits.
Researchers at NIDA's intramural program have found similar
cognitive deficits with chronic cocaine abusers. Thus, these studies
are clarifying how it is that illicit drugs compromise cognitive and
behavioral abilities.
NIDA-supported researchers are not just using new imaging and
molecular genetic technologies, they are also making significant
contributions to the field by advancing the technology themselves. This
is best exemplified by our efforts in the fast paced world of
nanotechnology. For example, NIDA-supported researchers recently
developed a biosensor system to analyze what is happening inside a
single cell. These techniques are allowing us to see how important
neurotransmitters like dopamine are stored and can move in and out of
cells. This opens up many new avenues of research; allowing us to see
with much greater resolution the impact that drugs of abuse have on the
brain.
determinants of drug use preferences and patterns
Understanding why some individuals abuse drugs while others do not
and why some develop more problematic drug use than others are some of
the most challenging dilemmas being probed by researchers today. As we
bring new and improved technologies and new groups of researchers into
the search for answers to these questions, we are beginning to unveil
some important and astonishing results. For example, using the advanced
brain imaging technique of positron emission tomography (PET),
researchers have found the first clues as to why some individuals are
prone to use stimulant drugs and why some are not. As an example, as
shown in POSTER 1, these studies have shown a dramatic association
between an individual's pre-drug exposure brain dopamine receptor
levels and how much the individual reports ``liking'' or ``disliking''
a psychostimulant. Here you see two individuals with different levels
of dopamine D2 receptors shown before any drug exposure. (Brighter
colors represent higher numbers of receptors). The individual whose
brain is shown on top and who had high levels of D2 receptors reported
an unpleasant response to the mild stimulant methylphenidate. On the
other hand, the individual on the bottom, with low D2 receptor levels,
found the stimulant quite pleasant. This suggests that differences in
brain chemistry predisposes people to respond in different ways to
drugs of abuse.
understanding the transition from drug user to addict
In past years, we also have shown you data clearly indicating that
we know quite a bit about both the behavioral and the biological
differences between addicted and non-addicted individuals. What we do
not know much about, however, is the literal transition that occurs
between these states. What is actually happening both behaviorally and
biologically when one moves from being an occasional to a compulsive,
addicted drug user? What changes an individual from a voluntary to a
compulsive drug user? Understanding this transition is central, of
course, to developing more effective addiction prevention and treatment
strategies, and its importance has led NIDA to develop a focused
``Transition to Addiction'' initiative.
NIDA-supported researchers will approach these issues from many
disciplinary perspectives. As just one example, they will use new
molecular biology techniques, such as microarrays, to build on recent
discoveries from animal studies suggesting that gradual increases in
the levels of a specific brain protein, delta Fos B, are a critical
part of this transition process. We know that this protein triggers the
expression of other genes and the use of this technology will help
identify which genes are expressed, when, and where in the brain.
research bringing about shifts in national strategy
Scientific advances have not only improved our fundamental
understanding of addiction, but continue to reduce many of the public
health and safety consequences of this destructive disease as well.
Nowhere is this better exemplified than in the philosophical shift in
strategic thinking about drug abuse and its consequences that is
occurring throughout many levels of society. A case in point is how
advances in addiction research are leading to a blending of criminal
justice and health approaches to dealing with drug abuse and
criminality. NIDA-supported research has demonstrated that treating
drug users while under criminal justice control dramatically reduces
recidivism to both later drug use and later criminality by 50 to 70
percent. This finding is one of the reasons why NIDA and other facets
of the Department of Health and Human Services have teamed with the
Justice Department to work toward making drug abuse treatment more
commonplace in the criminal justice environment.
addressing health disparities
Members of minority populations are disproportionately affected by
the consequences of drug abuse. Accordingly, NIDA is taking extra
effort to understand the causes of and contributing factors to these
inequalities and working to ensure that minority issues are addressed
and minority populations are adequately represented not only in NIDA's
comprehensive research portfolio, but in our research communities as
well. NIDA supports a wide array of programs to recruit minority
populations into drug addiction research fields. In fact, NIDA has
increased the number of supported minority researchers by 97 percent in
the past six years. In the last few years, NIDA has also put together
three new working groups representing African-American, Asian-Pacific
Islander, and Hispanic researchers and scholars to help recruit and
train new minority investigators and improve the quantity and quality
of minority-related research.
These working groups are helping NIDA expand opportunities for
working with scholars who are most knowledgeable about these
populations. Minority researchers will be particularly helpful as NIDA
increases its efforts to study the impact and health consequences of
drug abuse in minority populations. By simultaneously increasing
research and research training efforts, NIDA expects to make
significant improvements in racial and ethnic disparities.
rapid and authoritative research dissemination efforts
As the world's ability to exchange information expands
exponentially, NIDA continues to take full advantage of these
opportunities to disseminate science-based information more effectively
and rapidly to a wide variety of audiences. For example, when one of
our early drug warning systems, NIDA's Community Epidemiology Work
Group, noted increases in the use of ``club drugs'' such as
methamphetamine and ecstasy among adolescents and young adults, NIDA
initiated a multi-element research and education campaign to stave off
further growth of this problem. NIDA will increase funding for relevant
research by 40 percent. In addition, the Institute has joined with an
array of partners in the drug abuse professional and constituency
communities to launch a multi-media education campaign as well. We
developed and disseminated a community drug alert bulletin that has
been sent to over 150,000 people, developed a new website
(www.clubdrugs.org), and teamed with the American Academy of Child and
Adolescent Psychiatry, the Community Anti-Drug Coalitions of America,
Join Together, and National Families in Action to hold a national
meeting to increase awareness and attention to this problem, share
research findings, and identify research gaps.
We also have taken an idea from what has become a NIDA bestseller,
our Prevention booklet, ``Preventing Drug Use Among Children and
Adolescents: A Research-Based Guide,'' and created a corresponding
``Principles of Drug Addiction Treatment: A Research-based Guide.''
Since the guide debuted in October, more than 100,000 copies have been
disseminated. This lay language booklet provides health care providers,
patients, families, and policy makers with the latest science-based
information on drug treatment. It describes the nature of addiction and
the addiction treatment enterprise, and then outlines 13 overarching
principles that characterize effective drug addiction treatment.
We are also taking full advantage of other dissemination
opportunities. In fact, we are doing exactly what members of this
Committee encouraged us to do last year. We are taking state-of-the-art
brain scans showing the effects of drug abuse and addiction and using
them as the core of a multi-media public education campaign. What you
see here is a portion of a story board (POSTER 2) for one of our public
service announcements emphasizing how drug use can damage your brain in
important ways. In addition to using powerful images, we are using
findings from the prevention research arena on what works and what does
not work to develop persuasive, and scientifically accurate messages.
We plan to send these messages to television outlets nationwide this
spring.
government performance and results act
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
conclusion
In conclusion, NIDA is taking advantage of emerging technologies to
confront the disease of addiction head on. Our comprehensive research
portfolio, our track record in sharing our research findings, and a
continued commitment from the Administration and the Congress to
furthering the science will serve as this Nation' s best defense
against this devastating public health and safety plague. I will be
pleased to answer any questions you might have.
______
Prepared Statement of Dr. Enoch Gordis
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the NIAAA for fiscal year
2001, a sum of $288,578,000, which reflects an increase of $14,587,000
over the comparable fiscal year 2000 appropriation. Including the
estimated allocation for AIDS, total support requested for the NIAAA is
$308,661,000, an increase of $15,427,000 over the fiscal year 2000
appropriation. Funds for the NIAAA's efforts in AIDS research are
included within the Office of AIDS Research budget request.
Nearly 14 million American adults meet diagnostic criteria for
alcohol addiction or abuse, and 100,000 Americans die of alcohol-
related causes each year, according to NIAAA epidemiology data. While
death is the ultimate consequence of alcohol-use disorders, their
impact on the living, in sheer numbers, is even greater. The NIAAA's
epidemiology research reveals that 442,000 people occupy hospital beds
each year as a result of these disorders. The financial burden that
alcohol misuse imposed on the Nation in 1998 was approximately $185
billion, in direct and indirect costs, according to the Lewin Group.
The sequelae of alcohol-use disorders include damage to the liver,
brain, and other organs; cancer; fetal alcohol syndrome and the
lifetime disabilities it produces; accidental injury to self and
others; property damage; crime; broken families; and loss of
productivity that deprives the Nation of valuable resources.
Biological, behavioral, and social factors converge to produce
alcohol-use disorders, making them particularly complex diseases. In
terms of biology, alcohol is unique among addictive substances, in that
it targets not just one but many neurotransmitter systems--chemical
messengers between nerve cells--resulting in unusually pervasive
effects on the entire nervous system and in unique challenges for
scientists. Researchers have made striking advances in identifying the
molecular structures where alcohol binds to these neurotransmitter
systems and in learning how variations in genes determine alcohol's
actions on them.
neuroscience
Because alcohol's effects on the nervous system are so pervasive,
neuroscience is a particularly active field of research at the NIAAA.
One promising area involves neuropeptide Y (NPY), a substance in the
brain that increases food consumption and relieves anxiety. Studies are
underway to determine the role of NPY in controlling alcohol
consumption. Preliminary studies suggest that NPY may, indeed, play a
role in propensity for alcohol. Surprisingly, these studies revealed
that mice in which the NPY gene was inactivated (knocked out) drank
more alcohol than did their normal siblings and were less sedated by
alcohol. If NPY is found to play a key role in human alcohol-use
disorders, NPY and its receptors--its ``docking sites'' on cells--
become potential targets for medications to control alcohol intake.
Physical problems from long-term alcohol use do not necessarily
resolve once people stop drinking. Using new MRI techniques,
researchers have found persistent damage in the cerebellum, the locus
of gait and balance in the brain, even in long-abstinent alcoholics.
Previous anatomic measurements of cerebellar damage were difficult,
because of the cerebellum's convoluted structure, resulting in less
accurate data. Scientists can use these new imaging techniques to
clarify the potential for reversing cerebellar damage in recovered
alcoholics and to explore a new topic: the role of cerebellar damage in
cognitive impairment.
These and other findings from the NIAAA's comprehensive
neuroscience portfolio reflect the ubiquitous nature of alcohol's
effects on the nervous system. For example, research designed to
identify the protein structures where alcohol binds to nerve cells may,
one day, provide groundwork for development of better medications to
treat alcoholism. In another protein-related finding, NIAAA-supported
scientists have found that genes in the brains of deceased human
alcoholics produced less of a crucial nervous-system protein, myelin,
than did those in nonalcoholics. With this information, scientists can
better define changes in gene activity that result in damage to
specific areas of alcoholics' brains. Other investigators are
identifying alcohol-related neurobiological risks that fluctuate during
adolescence and that might be related to the higher risk of adult
alcoholism predicted by earlier onset of drinking in the young.
genetics
That genetics underlies much of the biology of alcohol-use
disorders is unquestionable. Variations in genes result in variations
in many components of the nervous system, and, thus, in how people's
bodies handle alcohol. The way in which people's bodies' handle alcohol
affects, in turn, their behaviors toward alcohol and risk for
alcoholism. Evidence suggesting that alcoholism is a polygenetic
disease--that many genes contribute to it--greatly complicates the
search for the genes involved.
The Collaborative Studies on the Genetics of Alcoholism (COGA), a
major project supported by the NIAAA, has identified several
chromosomal regions likely to contain genes that influence the risk for
alcoholism. The NIAAA is pleased to announce that it is making
available to the general scientific community the substantial data and
DNA samples generated by COGA. Scientists who take advantage of these
resources can analyze them further in their own research projects,
expediting the search for genes that contribute to alcoholism. The data
also can be used to evaluate new methods of statistically analyzing
genetic data, not only for alcoholism, but also for other diseases.
Among the goals of the COGA project is to elucidate the genetics of
alcoholism in African Americans. While COGA recruits both Caucasian and
African-American subjects, the latter have not been present in numbers
large enough to permit a reliable examination of whether the genetic
basis of alcoholism is different in Black Americans than in White
Americans. Through a NIAAA grant, Howard University Medical School will
study this question and contribute its findings to the growing COGA
database.
Neuropeptide Y, discussed earlier, is one of more than 20
substances that NIAAA scientists study as gene knockouts, to determine
their influence on alcoholism. Some of these substances are found to
increase alcohol consumption; others are found to reduce it. A recent
study examined the effects of knocking out, in mice, the gene that
produces protein kinase C epsilon (PKC ), an enzyme involved in
intracellular signaling. Absence of PKC resulted in significantly less
alcohol consumption and abnormally high sensitivity to alcohol's
sedating properties. Insensitivity to alcohol's sedating effects is
among the factors that portend alcoholism at some point in life. Since
much of the mouse genome resembles the human genome, these types of
findings may lead to clues about human genetic defects related to
alcoholism.
toxicology
Alcohol is unique among abused drugs in the extent of the organ
damage it causes. Animal studies by NIAAA intramural researchers have
demonstrated that chronic alcohol use leads to a decrease in essential
fatty acids (EFAs), nutrients that play a crucial role in brain health.
The same investigators recently demonstrated that EFA-deficient rats
lose nerve cells in an area of the brain involved in memory and
learning, another common result of chronic alcohol use. The NIAAA
continues to perform research to evaluate the potential of EFA
supplementation to reduce organ damage among alcoholics.
Between 40 percent and 90 percent of U.S. deaths from cirrhosis are
due to alcohol, according to NIAAA epidemiology data. These statistics
underscore the importance of understanding the potential for reversing
this currently irreversible disease. Scientists suspect that an immune-
system protein, tumor necrosis factor (TNF), plays a
role in alcohol-induced liver damage. NIAAA-funded researchers recently
found that alcohol-fed mice in which TNF's molecular receptor
had been genetically knocked out, eliminating TNF's actions,
suffered liver pathology seven times less severe than that of alcohol-
fed mice with normal TNF levels. This finding strongly
supports the assertion that TNF is involved in alcohol-induced
liver damage and is lent even more significance by the recent
development of pharmaceuticals that inhibit TNF in the
treatment of inflammatory diseases, such as arthritis.
advances in prevention and treatment
Recent studies illustrate what the NIAAA's prevention research can
contribute to decisions about alcohol legislation. Many states have
taken the important step of lowering their legal definition of
drunkenness from a blood-alcohol concentration (BAC) of 0.10 percent to
0.08 percent. However, studies of simulated merchant-ship piloting by
maritime cadets revealed that even half of that concentration, a BAC of
0.04, resulted in significantly impaired performance. The cadets failed
to sense their decreased judgment, underscoring the hazards of alcohol
use in the context of heavy-machinery operation and the workplace. Many
states still allow people to drive cars with a BAC more than twice that
of the alcohol-impaired cadets.
The public also benefits from prevention findings that the NIAAA
provides to alcohol-treatment practitioners. Thirty percent of
Americans are subjected to domestic violence at some point in their
lives, according to studies published in the New England Journal of
Medicine and funded by the National Institute of Mental Health, the
Emergency Medical Foundation, and the UCLA Southern California Injury
Prevention Research Center. NIAAA-funded investigators recently
concluded, in the Journal of Studies on Alcohol, that a combination of
behavioral marital therapy and standard treatment for alcoholism
resulted in a six-fold reduction in domestic violence. Of significance
here is not only the magnitude of reduction in violence, but also that
the reduction is sustained, as investigators determined in a 2-year
follow-up study.
In the treatment arena, NIAAA-supported studies reveal that the new
medication nalmefene is at least as successful in preventing relapse
among recovering alcoholics as is naltrexone, the recently FDA-approved
drug of choice. Nalmefene may have advantages over naltrexone,
including less risk of liver toxicity, providing another option for
recovering alcoholics whose livers have been damaged by alcohol. A
Finnish company plans to seek FDA approval for this new medication.
adolescent alcohol use
During last year's hearings, the NIAAA reported that initiation of
drinking earlier rather than later in youth is associated with a
dramatically higher risk of alcoholism at some point in life. For this
and many other reasons, the NIAAA continues to make drinking among
adolescents a research priority. The ``hard-wiring'' of the brain is
vulnerable to change during adolescence, including change caused by
toxic substances. Investigators supported by the NIAAA have found that
adolescent animals are less sensitive than adult animals to the motor-
incapacitating and sedating effects of alcohol. This suggests that
adolescents have higher drinking capacities, perhaps putting them at
higher risk for alcohol-related problems. Other researchers have found
that human youths who engaged in heavy, protracted drinking during
early and middle adolescence, when compared with nonabusing adolescents
of similar demographics, score significantly more poorly on
neuropsychological tests, and that these deficient scores may persist.
For example, young people who have withdrawn from alcohol recently have
poor visuospatial functioning, and those who have withdrawn in the past
show poor retrieval of verbal and nonverbal information.
The Washington Post and CNN recently reported another NIAAA
finding: An estimated one in four U.S. children is exposed to
alcoholism in the family. The stressful and unpredictable environment
in such families can lead to a variety of problems in these children.
outreach
In addition to conducting research on adolescent alcohol abuse, the
NIAAA has taken a leadership role in the Surgeon General's campaign to
prevent alcohol use among youth and engages in numerous outreach
activities. Recently, the NIAAA issued a pamphlet that educates parents
about alcohol use among youth, and this pamphlet now is being written
in Spanish. The NIAAA also is collaborating with the Robert Wood
Johnson Foundation to recruit governors' spouses in a National
Leadership Initiative to Keep Children Alcohol-Free. In January, the
NIAAA and Mothers Against Drunk Driving held two press briefings, one
for editors of teen magazines and the other for editors of women's
magazines. The NIAAA and the Substance Abuse and Mental Health Services
Administration (SAMHSA) are preparing to award a grant for public-
service announcements aimed at preventing underage drinking. In
addition, prominent scientists and 10 college presidents have formed a
subcommittee of the NIAAA Advisory Council, to identify ways of
reducing binge-drinking among college students.
Other NIAAA outreach activities include Alcohol Screening Day, the
first of which was held last year. Almost 500 college campuses were
among the 1,700 sites that participated. Approximately 52,000 people
attended, and 29,000 of them asked to be screened. This successful
event will be held again on April 6, 2000.
To ensure that its research findings reach the people to whom they
matter most--people who suffer from alcohol disorders--the NIAAA, in
collaboration with State agencies and SAMHSA, cosponsors a Research-to-
Practice initiative. Senior clinical investigators spend several days
at alcohol-treatment facilities, giving staff hands-on help in
incorporating innovations from basic and clinical research into their
treatment regimens.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report,
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
My colleagues and I will be happy to answer any questions you may
have.
______
Prepared Statement of Dr. Patricia A. Grady
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Institute of
Nursing Research (NINR) for fiscal year 2001, a sum of $84,714,000,
which reflects an increase of $2,672,000 over the comparable fiscal
year 2000 appropriation. Including the estimated allocation for AIDS,
total support requested for NINR is $92,524,000, an increase of
$2,985,000 over the fiscal year 2000 appropriation. Funds for the NINR
efforts in AIDS research are included within the Office of AIDS
Research budget request.
I would like to thank the Committee for your interest and support
for NINR and for nursing research. In this period of rapid
technological and demographic change, it is imperative that nursing
research grow to help meet present and future needs and expectations of
our nation's people for improved health care. More people will live
longer and face chronic illness and disabilities in older age. More
will be caregivers who will need to know how to live their own lives
while caring for ill relatives and friends. Many will be minorities at
risk for experiencing disparities in the incidence, prevalence and
seriousness of disease and access to care. How people live and how they
experience illness will be influenced by new technologies in the
healthcare system. Increasingly, they will demand a role in managing
their own health. Individuals will appreciate the value of prevention,
but will still need help in achieving healthier lifestyles. And
virtually everyone wants to die with dignity and a sense of control.
Today I will discuss our targets for fiscal year 2001 that relate to
these concerns.
chronic disease--a long-range view about long-term illness
Chronic illness continues to be an important NINR research
emphasis. We are investigating how to both avoid complications of
disease and disability and control symptoms such as pain, nausea and
poor sleep. Other studies will be directed at patients who are
discharged early from the hospital and still need substantial care at
home. A special focus will be on family caregivers, who have varying
expertise and financial and complex care demands for multiple lengthy
illnesses.
In addressing early hospital discharge, recent nursing research has
verified the value of a transitional care model that has been tested in
several patient populations. The model uses a multidisciplinary team
and involves comprehensive discharge planning, including determination
of patient care needs outside the hospital, and follow-up in the home
by advanced practice nurses specializing in geriatrics. As the chart
shows, six months following discharge, the intervention group of older
adults with common medical and surgical problems had 48 percent fewer
rehospitalizations, 54 percent fewer multiple hospital readmissions,
and 65 percent fewer days in the hospital at a 48 percent savings to
the healthcare system when compared to controls. Widespread use of this
model could save significant healthcare dollars and improve quality of
care.
Early hospital discharge has placed a research spotlight on family
caregivers, who often undertake the responsibility for care of their
ill relatives. Caregivers of Alzheimer's patients bear special burdens.
They must cope with the physical downward spiral of illness, and they
also must deal with the stress of patients' behavioral problems that
include agitation, depression, and wandering. Nurse researchers have
developed a successful intervention that offers behavioral management
skill training to caregivers. Five months after the intervention,
researchers found that caregiver stress continued to be reduced when
coping with disruptive behaviors of older adults in their care. The
study also showed a moderate decrease in caregivers' perceptions of
their burdens in providing care. Furthermore, those who were initially
depressed were less depressed. These positive results may be applicable
to caregivers of patients with other chronic illnesses, such as stroke
or congestive heart failure.
A life-long chronic illness that often starts in childhood, Type I
diabetes, represents 5 to 10 percent of the total number of people with
diabetes, and can seriously impact physical health and quality of life.
Our research on adolescents with this condition compared two types of
recommended intensive therapies--either multiple daily injections of
insulin--three or more a day--or subcutaneous infusion of insulin
delivered by insulin pump--a therapy which is currently used by fewer
than 5 percent of young people. Adjusting to the insulin pump has been
difficult for young adults, but when they are provided with an
intervention consisting of instruction and support, the outcomes have
been positive. Advanced practice nurses visited the adolescents every
four to six weeks and provided them with diabetes education,
adjustments in managing their diabetes and clinical assessments,
including measurements of hypoglycemia and adherence to dietary
restrictions. Investigators found that compared to teens on multiple
daily injections of insulin, those who used the insulin pump had fewer
severe hypoglycemic episodes and were able to maintain their blood
glucose levels within the proper range. The ``pump'' group scores also
showed better self esteem, coping skills, and quality of life. This
finding identifies the education and support that enables adolescents
to use the newer pump technology effectively.
NINR is committed to expand chronic illness research in fiscal year
200l to help patients manage their conditions over time. This involves
a major investment of resources. We will focus on strategies to be
applied broadly across chronic illnesses, including prevention of
disease and its complications, self-monitoring by patients of the
course of their disease, and promotion of patient success in problem
solving and in maintaining a healthy lifestyle.
the end of life--an emerging research focus
Just as biomedical advances are changing the way we live with
illness, they are also changing the way we eventually die. The duration
of both chronic illness and the dying process has been prolonged. In
fiscal year 2001, we will expand our focus on end of life to better
understand at what point palliative care becomes the primary goal. We
also need to know how best to facilitate communication and decision
making among all involved in the end-of-life period--the patient,
nurse, physician, family, and friends.
NINR is pleased that the response to last year's Request for
Applications for research on end-of-life care resulted in more than 100
applications--an impressive result for a relatively new area of
research. Those that were funded will form a basis upon which to build
an important, growing effort.
health disparities--closing the gap
Another area of importance to nursing research and to the nation is
reduction of persistent health disparities among certain populations in
our country. We must provide interventions that are more responsive to
the needs of our multiethnic and multicultural society. Nursing
research has long incorporated ethnic and cultural factors in designing
projects and testing interventions--with the goal of tailoring care to
the individual patient's needs. Yet more research is needed to identify
why disparities exist and what to do about them.
Let me provide an example of nursing research that addresses an
area of disparity in a growing population. For many years, there were
few resources available for Hispanics with arthritis to help them
manage their condition. Limited fluency in English had the effect of
excluding them from most health research projects. In response to this
need, nurse researchers developed and tested a successful Spanish
language arthritis education program. This endeavor was not limited to
translation from English to Spanish. Cultural differences within Latino
communities and accurate Spanish language measurement tools were also
addressed. During the program, patients learned how to exercise,
communicate with health care professionals, and manage pain, fatigue
and depression. Throughout a one-year period, patients experienced
significant improvements in all areas. The components of this course
have provided a useful model that is being tested for Hispanic
populations with coronary artery disease, chronic obstructive pulmonary
disease, and Type II diabetes.
NINR plans to continue its ongoing programs next year to help
eradicate healthcare disparities. We will focus specifically on
diabetes and its gaps in morbidity across ethnic groups. We will
emphasize strategies for effective self-management of illness, and
investigate the influence on health of genetics, education, poverty,
diet, behavior and social support. Another goal is to increase the
number of well-trained investigators to conduct minority health
research. To do this, we plan to expand core research centers and
career development opportunities.
clinical research
Most nursing research studies are clinical in nature, although they
can also involve basic research. An example of a recent finding
concerns the use of feeding tubes to provide required nutrition. Every
year an estimated one million hospital patients or residents of nursing
homes are fed through use of feeding tubes. Incorrect insertion or
dislocation of the tube may deliver food to the respiratory system,
which can be fatal to the patient. Studies have shown that current
clinical methods that rely on a stethoscope rather than X-rays for tube
placement are correct only 6 to 34 percent of the time. Nurse
investigators have discovered that an accurate, less costly alternative
to both techniques is measuring pH and bilirubin levels in aspirated
contents from the feeding tube. This method has identified the
misplacement of tubes in lungs with 100 percent accuracy and is less
expensive and safer than repeated X-rays.
Another important innovation for clinical research and practice is
telehealth--a long distance technology to reach underserved areas, such
as rural communities. NINR has been active in supporting telehealth
studies for treatment and monitoring of patients and for providing
health information. In the next fiscal year, NINR plans to expand
research to determine the effects of telehealth on various patient
populations and cost savings associated with telehealth strategies. We
also plan to target patients most likely to benefit from telehealth
interventions, identify barriers, and find ways to integrate telehealth
into other treatment and care regimens.
building nursing research capacity
Next year provides an opportunity to initiate new programs to
increase the nursing research capacity. In the current fiscal year, we
are launching the Summer Genetics Institute for extramural researchers.
This new eight-week training course emphasizes genetics in clinical
practice, in the research laboratory, and in nursing curricula. Other
training initiatives include an intramural career transition award that
combines postdoctoral training with subsequent support for beginning
research at an extramural institution.
NINR continues its collaboration with the Office of Research on
Minority Health in a career development program for minority nurse
researchers. Studies being carried out by these minority investigators
include reduction of serious developmental problems of migrant infants,
suicide prevention in a population of rural Indian youth, and improving
screening for prostate cancer in African-American men. NINR is also
collaborating with the National Coalition of Ethnic Nursing
Associations on a workshop to identify important research questions and
training needs for minority nurse scientists.
government performance and results act (gpra)
Prominent in the GPRA performance data is NIH's first performance
report which compares our fiscal year 1999 results to the goals in our
fiscal year 1999 performance plan. As our performance measures mature
and performance trends emerge, the GPRA data will serve as indicators
to support the identification of strategies and objectives to
continuously improve programs across the NIH and the Department.
conclusion
In conclusion, health research, health care, and health choices are
increasingly interdependent, and nurses and nurse researchers play a
vital role in all three areas. Continued growth of nursing research is
critical to meet public demands and urgent national health needs. Our
contributions to the scientific foundation that nourishes the work of
healthcare practitioners are already making a difference in health care
or have significant potential to do so. This base of knowledge merits
expansion in creative new directions. NINR looks forward to the
challenge.
Mr. Chairman, I am pleased to answer any questions the Committee
may have.
______
Prepared Statement of Dr. Francis S. Collins
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Human Genome
Research Institute (NHGRI) for fiscal year 2001, a sum of $353.4
million, which reflects an increase of $21.8 million over the
comparable fiscal year 2000 appropriation. Including the estimated
allocation for AIDS, total support requested for the NHGRI is $357.7
million, an increase of $21.9 million over the fiscal year 2000
appropriation. Funds for the NHGRI efforts in AIDS research are
included within the Office of AIDS Research budget request. The NIH
budget request includes the performance information required by the
Government Performance and Results Act (GPRA) of 1993. Prominent in the
performance data is NIH's first performance report that compares our
fiscal year 1999 results to the goals in our fiscal year 1999
performance plan. As our performance measures mature and performance
trends emerge, the GPRA data will serve as indicators to support the
identification of strategies and objectives to continuously improve
programs across the NIH and the Department.
This is my seventh appearance before this Subcommittee. I am again
pleased to report that the Human Genome Project continues to be ahead
of schedule and under budget. When I appeared before you last February,
Human Genome Project scientists had just completed sequencing the DNA
of the worm known as C.elegans; laying out the entire genetic code of
an animal for the first time. At that time, 405 million base pairs of
human DNA sequence had been deposited in GenBank by the large scale
human DNA sequencing pilot projects that were initiated in 1996. These
projects tested new ways to apply sequencing strategies to the large
and complex human genome.
human dna sequencing
A lot has happened in a year. Following the success of the pilot
projects, the NHGRI, the Department of Energy, and our international
partners (the U.K., France, Germany, Japan, and China) initiated last
March full-scale production sequencing of the 3 billion bases that
comprise the human genetic instruction book. The newly tested
sequencing strategies, coupled with advances in sequencing technology,
provided the necessary foundation to begin full-scale production.
Later this year, this international consortium will produce a
``working draft'' of the human genome sequence, an essential resource
for the whole research community. The working draft will provide 90
percent coverage of the human genome with an accuracy of 99.9 percent.
Then we will move on to complete the final, highly accurate, finished
human genome sequence in 2003 or sooner, two years ahead of the
original schedule
All sequence data produced by the international consortium is
deposited every 24 hours in GenBank, where it is freely available to
any researcher with an internet connection, without restrictions on
use. The rapid public availability of the sequence is invaluable to
academic scientists studying the molecular basis of human health and
disease, as well as corporate researchers engaged in drug development.
By November 17, 1999, the consortium had deposited the sequence of one
billion bases in the human genome. Today, over half of the sequence,
approximately 1.7 billion base pairs of non-redundant sequence, resides
in GenBank. This marks the production of over a billion base pairs of
human DNA since last year's hearing.
To reach this milestone, Human Genome Project participants actually
had to sequence over 12 billion base pairs of human DNA in overlapping
pieces. As project manager, I know this could not have been done
without the tireless work of the hundreds of dedicated scientists and
technicians at the major sequencing centers. The largest five of these
are referred to as the G-5 (the Whitehead Institute at MIT, the
Washington University School of Medicine in St. Louis, the Baylor
College of Medicine in Houston, the DOE's Joint Genome Institute in
California, and the Sanger Centre in the U.K.) and will do about 85
percent of the work.
chromosome 22
The Human Genome Project achieved another historic milestone this
year when an international scientific team announced the unraveling of
the genetic code of an entire human chromosome for the first time. The
33.5 million base pairs of Chromosome 22 were published in the December
2, 1999 issue of the journal Nature. Research now will focus on
determining what it all means. Sequencing and mapping efforts have
already revealed that genes on chromosome 22 are implicated in the
workings of the immune system, congenital heart disease, schizophrenia,
mental retardation, birth defects, and several cancers including
leukemia, but many more secrets will be discovered in this decoded
text. The results of this work give scientists insights into the way
genes are arranged along the DNA molecule and pave the way for major
advances in the diagnosis and treatment of disease.
Until last year, scientists were uncertain about whether an entire
human chromosome could be sequenced in this manner. For example, they
did not know whether insurmountable problems would prevent completing
the assembly of large stretches of contiguous sequence. The work done
on chromosome 22 not only answered any doubts about the ability to
sequence a chromosome, it validated the strategy being pursued by the
publicly supported Human Genome Project in sequencing the entire human
genome.
beyond the human sequence
While laying out the precise sequence of the 3 billion letters of
the human genome is an awesome and audacious undertaking, it is but one
of the many important objectives of the Human Genome Project. The 5-
year research plan published in the October 23, 1998 issue of Science
outlines seven other ambitious goals critical to the success of the
Project. One such tool is a catalog of common genetic variants.
human genetic variation
Any two human beings, regardless of ethnic or racial self-identity,
are 99.9 percent the same at the genetic level. But certain changes in
the sequence, some as subtle as a single letter change, contribute to
disease or disease risk. Today, to find the misspelling, or
misspellings, that contribute to common diseases, such as cancer,
Parkinson's disease, asthma, depression, or heart disease, researchers
must study pedigrees and search through large chromosome
``neighborhoods'' using the genetic map. But having the reference
sequence, and new technologies for finding those places in the genome
that vary among us, means that assembling a catalog of common genetic
variants is now possible, and will greatly speed the process of disease
gene discovery.
Most variants will be single letter differences, known as SNPs or
single nucleotide polymorphisms. Any SNPs found to be associated with a
disease will provide targets for further study to understand the
biological processes underlying health and disease and facilitate
development of diagnostic tests. This understanding will in turn fuel
development of improved prevention and treatment strategies. Because
genetic variants can also contribute to individual differences in
response to drugs, the identification and understanding of these
variants will allow doctors to choose the most effective drug based on
a patient's particular genetic makeup.
In fiscal year 1999, with contributions from 16 NIH institutes, the
NHGRI began an initiative to discover and catalog common variants in
human DNA. In the next two years, NIH-supported researchers expect to
find about 100,000 SNPs. Over the past year, this initiative has been
complemented by an innovative collaboration in the private sector. Last
April 15, a collaborative effort of 10 large pharmaceutical companies
IBM Motorola and the Wellcome Trust, announced the formation of The
SNPs Consortium (TSC). The Consortium's goal is to identify an
additional 310,000 SNPs. All SNPs identified by either the NIH or TSC
are regularly deposited into the publicly available SNP database. This
collaboration between the public and private sectors has already
produced and deposited 25,000 SNP's into the public database.
sequencing the laboratory mouse
Last fall, NHGRI began sequencing of the genome of the laboratory
mouse, one of The most frequently used mammals in biomedical research.
Ten laboratories, now referred to as the Mouse Genome Sequencing
Network (MGSN), collectively received funding. All mouse sequence
produced will fall under the same data release principles adhered to
for the sequencing of the human genome, i.e., assemblies greater than
2,000 base pairs will be released to public databases within 24 hours.
Mouse and humans are approximately 70 percent identical at the
genetic level. Both genomes contain approximately 3 billion base pairs
and encode an estimated 100,000 genes. The invaluable contribution of
mouse models toward a better understanding of human disease has long
been recognized in biomedical research. For example, mouse models
provide scientists with unprecedented insights into the molecular basis
of disease and the response to potential therapeutic agents. Intramural
scientists at NHGRI are developing and utilizing mouse models to study
a diverse array of human diseases. These include brain disorders such
as Huntington's disease, Parkinson's disease, neural crest disorders,
and blood disorders such as acute myeloid leukemia.
Sequencing the mouse is a priority for a wide spectrum of
biomedical scientists. Every institute at NIH, with support of the NIH
Office of the Director, made a contribution to the first year of
funding. NHGRI has assumed responsibility for funding the mouse
sequencing network in the second year and beyond. A significant
fraction of NHGRI's fiscal year 2000 increase is dedicated to support
of mouse sequencing.
finishing the fly genome
Looking ahead, achievement of another significant milestone is just
around the comer. Publication of the complete sequence of the fruit
fly, Drosophila melanogaster, is expected within a matter of weeks. The
fruit fly is another useful model organism for studying genetics, with
a genome of 160 million base pairs of DNA. Providing this research tool
is important because understanding the role of a gene in the human body
is often clarified by comparing its DNA code to that of other
organisms.
NHGRI supported scientists at the University of California at
Berkeley and the Baylor College of Medicine carried out the initial
scaffold sequencing of the fruit fly genome. In 1998, encouraged by
NHGRI, Celera Genomics began a collaboration with these groups. In
order to facilitate the work in both sectors, a Memorandum of
Understanding (MOU) was prepared between the publicly funded scientists
and Celera Genomics to outline the respective roles of each of the
partners. The MOU maintained the public sequencing effort's commitment
to seeing that complete, accurate sequence for this important model
organism is made freely accessible to all scientists by requiring that
the annotated sequence be released to GenBank upon publication.
tools for understanding the human genome
Once we have the sequence of the human and key model organisms in
hand, we will need the tools to allow us to explore and understand its
significance in health and disease. While this exploration will take
many years, it will be aided by tools now in development by the Human
Genome Project; tools that enable researchers to study the entire
genome and all its genes in a single experiment.
NHGRI has launched a number of initiatives to develop tools to
understand gene function that will grow in coming years. One such
initiative is the Mammalian Gene Collection, led jointly by NHGRI and
NCL This initiative will create a complete collection of cloned and
sequenced genes for humans and other mammals. In the future, scientists
will be able to go to the freezer to pull out any gene they want to
study. In parallel, new technologies such as microarrays are being
developed, that can measure and compare the extent to which a gene is
active under various conditions and in various tissues. The NHGRI
intramural program is one of the world leaders in this technology. Many
other clever approaches to studying gene function are being explored
and the field is expanding rapidly.
Both genomic sequencing and these new functional studies generate
vast amounts of data that must be organized, stored and analyzed in
order to allow scientists to pursue new leads in medical research. One
significant outcome of the Human Genome Project has been the
transformation of biology into a field that is rich in data, which has
spawned a new discipline, called computational biology. New tools for
handling data to make it readily accessible to scientists, as well as
new approaches for understanding the significance of the data, are
urgently needed. In view of this need, NHGRI plans to place a major
emphasis on funding computational genomics studies in the future. In
fiscal year 2001, NHGRI will launch a new Genome Centers of Excellence
program to support the development of novel technology and
computational approaches for studying the function of genomes. in
addition to funding innovative science, these Centers will also provide
an environment in which a new generation of genomic scientists can be
trained. The concept for the centers is similar to that recommended by
an Advisory Committee to the NIH Director for ``Programs of Excellence
in Biomedical Computing.'' The NHGRI anticipates that these Genome
Centers of Excellence will meet many of the objectives outlined in the
Committee's report, known as the ``BISTI'' (Biomedical Information
Science and Technology Initiative) report.
safeguarding the fair use of genetic information
From the outset of the Human Genome Project, the NHGRI has
supported research into the ethical, legal, and social implications
(ELSI) of genomic research and fostered the development of relevant
policy recommendations. We have a fundamental obligation to assess and
deal with concerns such as protecting the privacy and fair use of
genetic information, and the integration of new genetic technologies
into health care. If we do not and the public is fearful of obtaining
or disclosing genetic information, or has limited access to genetic
technologies, the promise of genetic medicine will not be realized and
we will have achieved little.
Progress on safeguarding the fair use of genetic information was
made just in the last few weeks. On February 8, 2000, President Clinton
signed an Executive Order to protect federal workers from
discrimination based upon their genetic information. This is built on
the bedrock principle that an individual's predictive genetic
information should be used for their benefit and not for harm. A
variety of important organizations, such as the American Medical
Association, Hadassah, the Genetic Alliance, the American College of
Medical Genetics, the Biotechnology Industry Organization (BIO) and the
National Society of Genetic Counselors, immediately expressed their
support for the President's action.
The Executive Order, which built upon the recommendations published
by the NIH-DOE ELSI Working Group and the National Action Plan on
Breast Cancer, is an important step toward assuring federal workers
that their genetic information will be kept private and be used against
them by their employer. It also provides federal and state legislators
with a useful template for extending protections to all workers. We
hope to see this step built upon in 2000 by the passage of effective
federal legislation barring the discriminatory use of predictive
genetic information in health insurance and employment.
conclusion
The dramatic progress of the Human Genome Project has exceeded the
expectations of even the most optimistic just a few years ago. In a
matter of months, the majority of the fundamental ``Book of Life'', the
human sequence, will be in hand. Having this virtual guidebook to the
human genome will permit many exciting opportunities. Combining this
with the catalog of human variation, and with new tools and
technologies developed by the Human Genome Project, will lead to
unlocking the mysteries of diseases, such as diabetes, Parkinson's,
schizophrenia, and common forms of cancer. That in turn will allow new
approaches to prevention based on each individual's disease risk
factors. And we can, a few years hence, predict a host of new gene-
based therapies specifically designed to fit an individual's genetic
makeup.
Mr. Chairman, and members of the committee, it has truly been a
privilege to be a part of this historic effort, known as the Human
Genome Project. At the beginning of the new millennium, genetics has
come to encompass nearly every aspect of health research and will
surely transform how we diagnose and treat disease in the future. It
will enhance our concepts of shared humanity, regardless of racial or
ethnic identity.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Judith L. Vaitukaitis
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Center for
Research Resources (NCRR) for fiscal year 2001, a sum of $602.7 million
which reflects an increase of $33.6 million over the Fiscal Year 2000
appropriation. Including the estimated allocation for AIDS, total
support requested for NCRR is $714.2 million, an increase of $39.1
million over the fiscal year 2000 appropriation. Funds for the NCRR
efforts in AIDS research are included within the Office of AIDS
Research.
It is a pleasure once again to have the opportunity to present the
accomplishments of NCRR-supported investigators and future directions
for NCRR programs. Before the recent turn of the millennium, doomsayers
predicted the end of the world as we know it, and in some respects they
were right. Advances in computer technology, bioengineering, imaging
technologies, neuroscience and genomics will revolutionize biomedical
research in the 21st century. The NCRR mission is unique among the NIH
institutes and centers. While the other NIH components focus on
particular diseases, organ systems, or categories of research, NCRR
alone has a trans-NIH mandate--to develop and maintain the research
infrastructure that enables all lines of biomedical inquiry. This
effort transcends both clinical and basic research. NCRR's nationwide
networks for basic and clinical research discern the molecular causes
of disease, develop new preventive strategies, and assess novel
therapies for diseases that affect majority as well as minority
populations across this Nation. By providing scientists access to
advanced technologies and sophisticated research facilities for
collaborative clinical and basic research, NCRR serves as a
facilitator--or catalyst--for biomedical discovery.
One of NCRR's main objectives is to utilize scarce or expensive
resources to the fullest by sharing them among many investigators. This
strategy is efficient and cost effective. Each year more than 20,000
investigators, supported by more than $2.5 billion in competitive grant
support from the other NIH components, use NCRR-supported research
resources. To meet the needs of biomedical investigators for access to
costly technologies, NCRR collaborates with the Department of Energy
and the National Science Foundation (NSF) to provide access for
biomedical investigators to high-energy x-rays at the synchrotron
facilities operated by those two agencies. In addition, NCRR provides
access to advanced computing for health-related research by partnering
with the NSF-supported San Diego Supercomputer Center, one of the two
National Partnerships for Advanced Computational Infrastructure
currently supported by the NSF.
NCRR-funded resources have been critical to numerous projects that
advance biomedical science. Many NCRR-supported discoveries have
immediate benefits for patients; others help basic research move
forward toward this ultimate goal. For example, separate groups of
scientists, using NCRR-supported beamlines for x-ray crystallography,
have determined the three-dimensional structure of ribosomes--our
cells' protein factories--in unprecedented detail. These studies may
expedite discovery of newer, more effective antibiotics. Animal studies
conducted at an NCRR-supported primate center have shown that it is
possible, by gene therapy, to reverse the brain cell destruction that
is characteristic of Alzheimer's disease; and NCRR-supported clinical
investigators have developed methods to assess changes in particular
areas of the brain of depressed patients. The identification of these
specific brain areas is fundamental to designing improved treatments
for depression. According to the National Institute of Mental Health,
depression affects more than 19 million American adults and costs
society more than $30 billion in 1990.
bioengineering, computers, and advanced instrumentation
The ongoing technological revolution has made it abundantly clear
that biomedical science is no longer the sole province of physicians,
biochemists, and biologists. Engineers, physicists, and computer
scientists are essential partners for developing and adapting new
instruments and technologies for health-related research. For example,
improved imaging systems are needed to investigate the pathophysiology
of human disease by studying patients as well as small animals and
nonhuman primates as disease models. To obtain the same resolution as
in humans, these imaging systems must have sensitivities that are up to
2,500 fold greater. NCRR proposes to support further technological
development of high resolution imaging tools that include computed
tomography, magnetic resonance imaging (MRI), and positron emission
tomography.
Functional MRI imaging has provided investigators a powerful
technology for studies of the human brain and has contributed
significantly with other complementary technologies to a virtual
revolution in neuroscience research. To further take advantage of these
imaging and related technologies, NCRR proposes to support the
establishment of regional MRI imaging resource centers where experts in
developing and using functional MRI can work with neuroscientists to
study brain disorders and also explore novel therapies, including stem
cell therapy to arrest, reverse, or even cure neurodegenerative
diseases. NCRR plans to functionally link those NCRR-supported
Biomedical Technology Research Resource Centers equipped with
sophisticated imaging capabilities with General Clinical Research
Centers at the same host institution in order to accommodate patients
from across this country for studies of neurodegenerative and other
brain disorders, supported by NIH categoric institutes.
The use of high-level computers and advanced computer programs are
essential components of today's biomedical research, but many
biomedical scientists are not sufficiently familiar with
bioinformatics, a key enabling technology. To help alleviate this
urgent need, NCRR proposes to establish bioinformatics centers that
will advance research in particular areas of biomedical investigation,
as part of the Biomedical Information Science and Technology Initiative
(BISTI). Those centers will create homes for interdisciplinary teams
that will establish nurturing environments for exploration and
research. Biomedical investigators are generating data in profuse
quantities. For example, a single biomedical laboratory can produce up
to 100 terabytes of information a year--about the same as the
information in one million encyclopedias. In order to be useful, the
data must be indexed and stored, analyzed and abstracted. To facilitate
analysis of this data, NCRR proposes to establish another program that
will foster development of tools to design future studies.
Synchrotron resources--which produce the high-energy x-rays used
for determining the 3-D structures of molecules--have an enormous
impact on structural biology and drug design. The number of NIH users
at NCRR-supported synchrotron beamlines doubled between 1995 and 1997,
and requests for access to these facilities are increasing at an
exponential rate. NCRR proposes to alleviate the projected substantial
shortfall for access to beamtime by adding more technical staff so that
technical support is available around the clock. New beamlines at the
Advanced Photon Source at the Argonne National Laboratory may allow
investigators to address more advanced structural biology grand
challenges. In addition, several new beamlines must be built at the
Advanced Light Source at the Lawrence Berkeley National Laboratory and
designed for high throughput studies of less complex structures to meet
the anticipated high volume of need for this approach. This effort will
combine new developments in beamline design, x-ray detectors,
cryocrystallography, robotics, and computational software.
genetic medicine
Manifestations of gene action are explored through phenotypic
assessment of genetically altered animals and biologic characterization
of macromolecules expressed by both normal and altered genes. NCRR
proposes to support regionally-linked resource centers for phenotypic
studies of genetically altered research animal models. These resource
centers will provide a critical infrastructure for analysis of gene
function in animal models of human diseases. NCRR must provide those
regional resources and several other biorepositories for genetically
altered biologic collections and additional funding for more technical
staff to help maintain the rapidly expanding biologic collections.
Additional staffing is also needed to curate and standardize the
genetic databases for those important research models--including flies,
fish, and worms. Without continuous updating and editing, databases
quickly become useless and as a result, unnecessary duplication of
research results.
health disparities
NCRR proposes to help alleviate health disparities for several
diseases that disproportionately affect minority populations by
competitively establishing several Comprehensive Centers on Health
Disparities (CCHD). Those centers are to be hosted by medical schools
located at universities that have an NCRR-supported Research Centers in
Minority Institutions (RCMI) facility for clinical research. The NCRR
CCHD initiative will focus on diabetes, AIDS, and infant mortality, but
initially will place increased emphasis on cancer screening and
management of cardiovascular disease and stroke. This effort will be in
partnership with appropriate categoric NIH institutes and with nearby
General Clinical Research Centers.
research capacity
NCRR proposes to continue support for construction or renovation of
biomedical research facilities to assure that state-of-the-art research
laboratories are available to conduct the most sophisticated research.
According to a 1998 National Science Foundation survey, at least 65
percent of biomedical research laboratories are inadequate to host
sophisticated research. Grant awards for construction or renovation
through NCRR's Research Facilities Improvement program are not intended
to be the major source for institutional funding of research laboratory
construction or renovation.
NCRR proposes to expand its Animal Facility Improvement program to
meet institutions' needs nationally to upgrade animal research
facilities to perform genetic research with rodents, nonhuman primates
and other animal models. To assist research-performing Historically
Black Colleges and Universities and other minority-serving institutions
in bringing their animal research facilities up to AAALAC standards,
NCRR proposes a special initiative to address this problem.
career development
Over the past several years, fewer young physicians have pursued
research careers. To help address that problem, NCRR has initiated
programs to increase the number of young physicians in the clinical
research pipeline. NCRR proposes to extend that effort in fiscal year
2001. That effort includes expanded support for a year-long medical
student mentored clinical research training program. The intent of this
program is to serve as a catalyst for young physicians to pursue
careers in patient-oriented research. The institutional GCRC or the
RCMI-funded Clinical Research Center will serve as a focal point for
patient-oriented research, through mentored didactic training and
``hands-on'' research. This new program will support up to 90 students
per year. NCRR also proposes to increase the number of Mentored
Patient-Oriented Research Career Development Awards to physicians and
dentists at GCRC sites. This very successful program was formerly known
as the Clinical Associate Physician (CAP) program.
A serious shortage exists of trained veterinary pathologists to
meet the collaborative research needs of scientists to assess the
phenotypic manifestations of genetically altered animal models of human
disease. To enhance the pipeline, NCRR proposes to initiate a one-year
program for veterinary students that will provide a mentored biomedical
research experience at research-intensive institutions. In addition,
NCRR proposes to increase the number of Special Emphasis Research
Career Award to train veterinarians in health-related research as
pathobiologists. The NCRR programs are intended to address the
inadequate number of research-trained veterinarians who participate in
biomedical research.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
which compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Stephen E. Straus
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget request for the National Center for
Complementary and Alternative Medicine for fiscal year 2001, a sum of
$71,362,000, which reflects an increase of $3,381,000 over the
comparable fiscal year 2000 appropriation. Including the estimated
allocation for AIDS, total support requested for the National Center
for Complementary and Alternative Medicine is $72,392,000, an increase
of $3,381,000 over the fiscal year 2000 appropriation. Funds for the
National Center for Complementary and Alternative Medicine efforts in
AIDS research are included within the Office of AIDS Research budget
request.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
Prominent in the performance data is NIH's first performance report
that compares our fiscal year 1999 results to the goals in our fiscal
year 1999 performance plan. As our performance measures mature and
performance trends emerge, the GPRA data will serve as indicators to
support the identification of strategies and objectives to continuously
improve programs across the NIH and the Department.
At the outset, I should note that NCCAM's work reflects the growing
public interest in complementary and alternative medicine (CAM) and the
belief that various CAM therapies may play a role in improved public
health. Approximately 42 percent of U.S. healthcare consumers spent $27
billion on CAM therapies in 1997. CAM enjoys particular popularity
among baby boomers. A number of practices, once considered unorthodox,
have proven safe and effective and assimilated seamlessly into current
medical practice. Diet and exercise are today commonly used to prevent
and control disease. Acupuncture is routinely applied to manage chronic
pain and nausea associated with chemotherapy. Some of our most
important drugs--digitalis, vincristine, and taxol--are of botanical
origin.
Additional CAM practices have the potential to prevent and treat
chronic disease, to improve understanding of how healing works and to
be integrated into the routine practice of medicine. Absent definitive
evidence of effectiveness, however, alternative practices may impart
untoward consequences for large numbers of people.
As the NCCAM's first permanent director, I am excited by the
challenge afforded me to help provide the American public the guidance
it deserves. As CAM use by the American people has steadily increased,
many have asked whether reports of success with these treatments are
valid. It is critical that untested but widely used CAM treatments be
rigorously evaluated for safety and efficacy. It is similarly important
to identify promising new approaches worthy of more intensive study.
The promising areas for future investments are numerous.
In order to best seize these opportunities, the NCCAM's strategy
must differ from that used by other NIH Institutes and Centers. Others'
projects are usually driven by basic science discoveries. In contrast,
the NCCAM must focus first on definitive clinical trials of widely
utilized modalities that, from evidence-based reviews, appear to be the
most promising. Credible, not anecdotal, data must be provided to the
public, and we must educate conventional medical practitioners about
the panoply of effective CAM practices, so they can be integrated into
patient care. In recognition of these needs, Congress responded in 1998
by elevating the NIH Office of Alternative Medicine (OAM), expanding
its mandate, creating the NCCAM, and affording it administrative
authority to design and manage its own research portfolio. The Congress
continued to reflect the growing interest in CAM by further increasing
funding for the Center in fiscal year 2000 to $68.4 million. We are
indeed appreciative of this support. The Congress vested the NCCAM with
a broad statutory mandate to conduct and support CAM research, support
research training, and disseminate information on validated CAM
therapies. Accordingly, the NCCAM is currently developing a strategic
plan to ensure that our continued growth, development and research
directions are consistent with these responsibilities. Five strategic
areas have been identified as: Investing in research; training CAM
investigators; expanding outreach; facilitating integration; and
practicing responsible stewardship.
In seeking to fulfill its mandate, the NCCAM has undertaken a
number of initiatives, established critical contacts with CAM
practitioners, and begun to fashion the scientific underpinning that
will enable future research discoveries.
Before describing these activities, I want to share with the
Subcommittee my vision of where I expect complementary and alternative
medicine to be in the years to come. As a result of rigorous scientific
investigation, several therapeutic and preventative modalities
currently deemed elements of CAM will prove effective. Therefore, in
future years, these interventions will be integrated into conventional
medical education and practice, and the term ``complementary and
alternative medicine'' will be superseded by the concept of
``integrative medicine.'' The field of integrative medicine will be
seen as providing novel insights and tools for human health, and not as
a source of tension that insinuates itself between and among
practitioners of the healing arts and their patients. Advances in
neurobiology will reveal more about ancient practices such as
acupuncture and meditation, as well as the phenomenon of ``the placebo
effect'' as we tap the healing power of the mind. The medical basis for
effectiveness of selected herbal and nutritional supplements will be
clarified, leading to their standardization and routine use. Other
modalities will be found unsafe or ineffective, and an informed public
will reject them.
My vision is an optimistic one. However, I am confident that, as it
is realized, the NCCAM will have not simply expanded in those ways
required to meet its research mission. Rather, owing to a tradition of
superb science and consumer service, the NCCAM will become the leader--
and recognized as such--within a vibrant, and global, CAM research
community.
Already, I have begun to recruit key experts to join me in
developing our programs in intramural research, clinical research,
international and traditional health studies, and traditional medicine
and indigenous systems. We will continue to grow our intellectual
capital and research capacity. Setting these cornerstones in place will
enable us, together with our partners in CAM research, to provide
definitive answers regarding CAM treatments.
current research studies
In its first year, NCCAM has developed a diverse research portfolio
in partnership with the other NIH Institutes and Centers. I am pleased
to highlight for you our support of some of the largest, and certainly
the most definitive Phase III clinical trials ever undertaken for a
range of CAM therapies.
For centuries, extracts from the leaves of the Ginkgo biloba tree
have been used as Chinese herbal medicine to treat a variety of medical
conditions, including age-related decline in memory. A new NCCAM study,
in collaboration with the National Institute on Aging (NIA), may help
resolve these questions. This study includes four clinical centers and
will enroll almost 3,000 participants who will receive either Ginkgo
biloba or a placebo.
Arthritis is a major public health problem for older Americans.
Accordingly, in collaboration with NIAMS, NCCAM has mounted two
critical clinical trials for the treatment of osteoarthritis. One is
the first U.S. multi-center study to investigate the dietary
supplements glucosamine and chondroitin sulfate--two natural
substances, found in and around joint cartilage. The other study is an
evaluation of acupuncture for the treatment of pain associated with
osteoarthritis.
I am pleased to report that our study of St. John's wort for
depression is nearing completion. This study, sponsored by the NCCAM,
NIMH, and the NIH Office of Dietary Supplements (ODS), represents the
largest and most rigorous assessment of the effectiveness and safety of
St. John's wort. Investigations of St. John's wort illustrate the
complex challenges afforded by some CAM modalities. A recent study
reported in The British Medical Journal showed that St. John's wort is
more effective than placebo in treatment of depression, and perhaps as
effective as an older generation anti-depressant drug Imipramine.
NCCAM's study, which is considerably larger than the European trial,
compares St. John's wort with placebo and with Zoloft, currently one of
the most commonly used anti-depressants. However, the therapeutic
promise of St. John's wort and of botanical products like it, is
accompanied by risks that the public has largely ignored. An NIH study
published February 12th in the Lancet found that St. John's wort, when
taken together with the important HIV protease-inhibiting drug,
Indinavir, increased the rate at which Indinavir was eliminated from
the bloodstream, to the extent that blood levels fell below the
acceptable level for effective AIDS treatment.
NCCAM continues support for four Specialized Research Centers
(cardiovascular disease, substance abuse, pediatrics and chiropractic)
funded originally by the Office of Alternative Medicine. By the end of
fiscal year 1999, NCCAM made five additional Specialty Research Center
awards. The nine Center grants total approximately $63 million. Each
focuses on one of several areas, including pediatrics, addiction,
cardiovascular disease (CVD), minority aging and CVD, aging,
neurological disorders, craniofacial health, arthritis, and
chiropractic medicine. In addition to these nine Centers, NCCAM and ODS
jointly established two Dietary Supplements Research Centers to advance
the science of botanicals, including issues of their composition,
safety, and biological action. Another request for Center grant
applications focusing on asthma and cancer recently was released for
fiscal year 2000. This, coupled with our anticipated solicitation of
one more botanical center in fiscal year 2000, will likely bring our
total number of NCCAM-supported centers to as many as 15.
Benign prostatic hyperplasia (BPH), or non-cancerous enlargement of
the prostate, is the most common benign tumor found in men. Anecdotal
reports suggested that the botanical product saw palmetto decreases
prostate swelling. To determine the validity of these observations,
NCCAM, in collaboration with National Institute on Diabetes and
Digestive and Kidney Diseases (NIDDK), is supporting the first
rigorously designed, placebo-controlled study to evaluate the effect of
saw palmetto extract on symptoms and quality of life in men.
future scientific plans and projects
Because of the dearth of credible scientific evidence on CAM
practices, there is unprecedented opportunity for determining the
efficacy and safety of CAM modalities. We have developed the following
initiatives to address them:
NCCAM has planned a collaboration on the treatment of liver disease
with the NIDDK and the National Institute of Allergy and Infectious
Diseases (NIAID). The project will examine the efficacy of milk thistle
extract--Silybum marianum--when used to treat Hepatitis C and other
hepatic diseases.
NCCAM has already begun a number of activities that will serve to
facilitate the integration of validated CAM therapies into conventional
medical practice. The NCCAM plans to make awards to foster
incorporation of CAM information into the curricula of medical and
allied health schools and continuing medical education programs. Also,
the NCCAM must educate eager medical students about CAM so that they
may knowledgeably guide an avid patient base toward safe and effective
CAM applications. We must also work to overcome the reluctance of
conventional physicians to consider validated CAM therapies and to
assimilate proven ones into their practice. The Center has established
a Clinical Research Curriculum Award (CRCA) to attract talented
individuals to CAM research and to provide them with the critical
skills that are needed.
A majority of the CAM modalities practiced in this country have
arisen from the traditional healing practices of other nations. Some of
the practices have ``evolved'' or been adapted to work within the
context of our society, and often in parallel with conventional medical
practices. Moreover, most of these practices are not well documented
within the context of their native cultures or understood within the
context of our own. Unraveling these issues will provide some important
insights into how these CAM modalities are practiced and impact upon
the health of U.S. minority populations--new immigrants like Hmong
(from southeast Asia) and established groups like the Navajo. Likewise,
the development of culturally sensitive studies will enable NCCAM to
establish methodological feasibility and strengthen the scientific
rationale for proceeding to full-scale, randomized, clinical trials on
the application of traditional, indigenous systems. The ability to
validate some of these therapies will also expand healthcare options
for those who are primarily consumers of convention medicine. The
international character of CAM necessitates that the NCCAM develop a
broad-based international research program that reaches out to CAM
practitioners across the world. Therefore, in collaboration with
several other ICs, NCCAM is committed to support locally-based,
traditional, indigenous research projects in countries where the
opportunities for promising CAM research are greatest. That process
will ensue with the forthcoming appointment of a Director for
International and Traditional Medicine Studies, who will develop a
long-range plan for the pursuit of studies on a global scale.
Foreshadowing this appointment, I have already authorized NCCAM
support, in collaboration with the NICHD, for international studies of
traditional medical approaches to the health of women and children.
The NCCAM will establish an Intramural Research Program that will
develop a critical mass of CAM research to stimulate collaboration in
the NIH Clinical Center with other Institutes and Centers, our Federal
research partners, and others. The intramural program will serve as a
focus for training future CAM researchers. Last month I formed a search
committee to identify the Director of this program.
information dissemination
Specific statutory authority enables the NCCAM to disseminate
information regarding the safety and effectiveness of CAM therapies to
health care providers and the public. A focal point for information
about NCCAM programs and research findings, the NCCAM Information
Clearinghouse develops and disseminates fact sheets, information
packages, and publications to enhance public understanding about CAM
research supported by the NIH. Its quarterly newsletter, Complementary
& Alternative Medicine at the NIH is distributed to 6,000 subscribers.
The NCCAM's award winning World Wide Web site, first established two
years ago, reflects the NCCAM's growth in size and stature. Averaging
more than 460,000 hits per month, the site includes links to NCCAM
program areas, news and events, research grants, funding opportunities,
and resources. Assembled by NCCAM from the National Library of
Medicine's (NLM) MEDLINE database, the CAM Citation Index (CCI) affords
the public access to approximately 175,000 bibliographic citations
searchable by CAM system, disease, or method. Also, in February 1999,
NCCAM joined the federally supported Combined Health Information
Database (CHID), which includes a variety of health information
materials not available in other government databases, including nearly
1,000 CAM citations not available elsewhere.
To facilitate our outreach to the general public, I have initiated
a series of town meetings; the first will be held on March 15 in
Boston, in conjunction with the Center for Alternative Medicine and
Education of Beth Israel Deaconess Medical Center.
I am now happy to take your questions about these or any other of
NCCAM's activities and plans.
______
Prepared Statement of Dr. Gerald T. Keusch, Director, Fogarty
International Center
Mr. Chairman and Members of the Committee, I am pleased to present
the President's non-AIDS budget request for the Fogarty International
Center (FIC) for fiscal year 2001, a sum of $32,532,000, which reflects
an increase of $3,620,000 over the comparable fiscal year 2000
appropriation. Including the estimated allocation for AIDS, the total
support requested for the FIC is $48,011,000, which is an increase of
$4,683,000 over the fiscal year 2000 appropriation. Funds for the FIC
efforts in AIDS research are included within the Office of AIDS
Research budget allowance.
I am delighted to relate our progress over the past year and our
proposed plans for fiscal year 2001. The FIC has taken a lead role in
formulating and implementing biomedical research and policy. The
programs of the FIC, developed in close consultation with this
Committee, reflect our Nation's enduring commitment to global health
equity. But disparities in health still exist. While one-fifth of the
world's population enjoys an average life expectancy approaching 80 and
a life comparatively free of disability, two-thirds of the world's
population, living in the least well-off countries of Africa, Asia, and
Latin America, suffer overwhelmingly from the world's burden of illness
and premature death. According to statistics compiled by the World
Health Organization (WHO), each year in the developing world 15 million
children die from infection and malnutrition--40,000 children per day--
and the toll in sickness and life-long disability has even greater
social, economic, and political consequences. Arguably, reversing this
deepening disparity is a public health urgency in the new decade that
demands increasingly creative actions from the scientific community.
Disparities in health are not limited by national boundaries.
Research on conditions related to poverty in resource-poor nations have
universal applications. Most recently, this has been demonstrated by
the development of short-course treatment regimens for tuberculosis,
field tested initially in Tanzania and now applied by public health
authorities throughout the United States. Adapting research advances in
biomedicine to populations at home and abroad requires a continuing
commitment to basic science as well as rigorous clinical and applied
studies. Our mandate at FIC is to serve as NIH's international catalyst
by enabling U.S. institutions to extend the geographic scope of
research and training. FIC supports over one hundred U.S. institutions
that collaborate with more than ninety nations. These efforts are
multidisciplinary, embracing clinical, epidemiological, basic
biomedical and behavioral research. They are multisectoral, coordinated
with our sister institutes at NIH and with international organizations
with health and development mandates, including the World Health
Organization and World Bank.
One principal strategy of the FIC is to create the human capital
and institutional capabilities in developing nations necessary for a
productive research enterprise. FIC places priority in four foundation
disciplines: First, information science and technology, as both an
analytical tool and a means to create global laboratories without
walls; second, epidemiological and clinical methodologies necessary to
characterize disease burdens and devise and evaluate therapeutic or
preventive interventions; third, human genetics and genomics, so that
developing nations may contribute to and benefit from international
efforts to apply genetic discoveries to clinical practice and
therapeutics; and fourth, ethical principles and practice in patient-
oriented research, with the intent of ensuring the depth and
transparency of the process of ethical review and the involvement of
co-investigators and study volunteers as equals in accordance with
international guidelines as well as local norms.
The selected examples that follow characterize several of our
leading priorities in global health research and training.
developing cost-effective methods of preventing hiv
Over ninety percent of the world's estimated 33 million persons
infected with HIV live in developing countries (UNAIDS). Within the
next five years, 61 of every 1,000 children born in southern Africa
will not reach their first birthday due to AIDS and increasing
longevity gains will be reversed. Progress in preventing future
infections is dependent on rigorous scientific links with developing
nations. This is the objective of FIC's AIDS International Training and
Research Program, the most extensive HIV research and training network
among U.S. schools of medicine and public health and counterparts in
developing nations. In partnership with the National Institute of
Allergy and Infectious Diseases, FIC provided training and
infrastructural support for Ugandan-based trials to prevent perinatal
HIV transmission through regimens of the anti-retroviral drug
nevirapine. A single oral dose given to an HIV-infected women in labor
and another given to her infant within three days of birth reduced the
transmission rate by half at a cost of $4.00 per mother-infant pair. If
implemented widely in developing nations, this intervention could
prevent some 400,000 newborns per year from beginning life infected
with HIV.
novel approaches to treatment and control of emerging infectious
diseases
Coupled with the AIDS crisis, parasitic and other infections
continue to compound the burdens of mortality and chronic illness as
well as impede economic growth in affected regions. According to WHO,
malaria kills close to 2 million people each year, most are children
under the age of five, and an estimated \1/2\ to 1 billion cases of
malaria occur, and this is closely associated with poor economic
performance in the affected countries. Progress will require a new
public health paradigm: An integrated approach to prevention and
control, incorporating improvements in case management, rational drug
use to limit the spread of resistance, monitoring and evaluation of
control measures, and development of new diagnostic tools, drugs and
vaccines. Moreover, the spread of HIV is hastened through the use of
unscreened blood to treat the life-threatening anemia that often
develops in malaria-infected individuals. This reinforces the need for
operational strategies to ensure the safety of the blood supply and
transfusion practices for the anemia of malaria, a major complication
of the infection. The Multilateral Initiative on Malaria (MIM), an
alliance of scientific and development agencies and African partners,
was launched with major support from FIC and NIAID to address these
critical needs. FIC now serves as the worldwide focal point for the
MIM. To promote the agenda to reduce the burden of malaria, FIC has
initiated a new research and training program to link U.S. and, in
particularly, African institutions. The MIM constitutes a maturing
model--a paradigm of cross-sectoral cooperation that FIC hopes to adapt
to other global health urgencies.
The field of malaria and other tropical infections has reached a
watershed, demonstrating the potential for application of tools of
molecular and cell biology to render formerly intractable problems
approachable. For example, dengue fever and its most severe form,
dengue hemorrhagic fever/dengue shock syndrome, are considered among
the most important and widespread reemerging infectious diseases in the
developing world, including the Caribbean. Global warming impacts on
mosquito vectors that makes this a threat to the U.S. mainland as well.
To date, existing methods to diagnose and characterize dengue viruses
have been costly and complicated to perform, particularly in developing
countries with limited capabilities and resources. Under FIC support,
the University of California at Berkeley and the Ministry of Health in
Nicaragua have developed a new technique to rapidly, accurately, and
inexpensively define the virus responsible for dengue in Central
America. This method is known as restriction site-specific PCR
(polymerase chain reaction). Using this new information, local health
authorities now are able to track the movement of the dengue virus from
Asia and Africa to the Americas, which is the start of control efforts.
Dengue is among more than thirty-five infectious diseases that have
emerged or reemerged around the world in the past twenty-five years.
Most recently, the outbreak of encephalitis in the New York region was
attributed to the West Nile Virus, its first known introduction into
the Western hemisphere. Although it is not clear how the virus migrated
to the United States, this outbreak is representative of the continual
challenge that newly emerging microbes present for U.S. citizens.
Emerging infectious diseases are infections that are new in the
population, rapidly increasing in incidence or expanding in geographic
range. Most are caused by ``microbial traffic''--that is, the
introduction and dissemination of existing agents into human
populations either from other species or from smaller populations,
often precipitated by rapid ecological and environmental change. To
better comprehend the consequences of changes in terrestrial and marine
ecosystems on human health, the FIC, in partnership with several NIH
Institutes, the National Science Foundation, and other U.S. agencies,
initiated an interdisciplinary research program to elucidate the
underlying biology of habitat and biodiversity changes that may lead to
increased disease prevalence in humans and, thus, fill an important gap
in our understanding of these interrelated dynamics. With this
information, we will be able to develop data and predictive models to
anticipate future outbreaks and devise corrective actions before the
disease strikes.
taking steps to address emerging epidemics of noncommunicable disease:
fiscal year 2001 initiatives
The classic burdens of infectious diseases in developing nations
are now joined by a new class of epidemics. According to the Global
Burden of Disease Study commissioned by the World Bank, over the next
twenty-five years as populations age and risk exposures shift, non-
communicable diseases will become the leading source of disability and
premature death in developing nations. Both the pace of these changes
and the sheer numbers affected will exceed the Western experience. By
working in partnership with scientists in low- and middle-income
nations, risk factors may be evaluated and interventions developed that
will be of benefit to both industrialized and developing nations. The
emerging epidemics of chronic disease in developing nations constitute
FIC's major programmatic thrust for fiscal year 2001.
In cooperation with the WHO Tobacco Free Initiative and multiple
NIH partners, FIC will establish a research and training program to
improve international efforts to control the tobacco epidemic. Among
other objectives, the program will address large gaps in our knowledge
relating to the burden of death and disability associated with tobacco
use in developing nations, such as behavioral determinants of smoking
uptake in youth. The Center also will launch a similar effort directed
at prevention and management of mental health disorders--an unseen
epidemic in most developing countries. At any give time, an estimated
10 percent of the population in developing nations suffers from severe
anxiety, depressive disorders and other psychosocial problems (World
Mental Health: Problems and Priorities in Low-Income Nations, Oxford
University press, 1995). Through international partnerships, we hope to
begin to rectify the shortfall of well-trained clinical investigators
and epidemiologists in mental health fields in developing nations.
Moreover, we will begin to generate epidemiological data on the
incidence of mental health disorders and risk factors, including
sociocultural determinants of mental health in societies undergoing
transition to industrialized economies.
In fiscal year 2001, the FIC also proposes to create new linkages
with developing nations in the field of molecular medicine, emphasizing
research and training related to the complex interplay between genes
and the environment. The genetic maps, physical maps and technologies
that have emerged from the human genome sequencing effort have enabled
the research community to accelerate dramatically the discovery of
genes underlying disease or risk factors for disease. We are now
positioned to advance understanding of population genetics and dynamics
for chronic conditions that affect industrial and developing nations
alike, such as hypertension, type 2 diabetes, asthma, and breast
cancer. FIC's long-range goals are to define some of the genes involved
in multigenic disorders of global priority and then test the predictive
strength of these particular polymorphisms in prospective, community-
based studies. Ultimately, diagnostic, therapeutic, and prevention
strategies will evolve.
Our current efforts in this field already have yielded promising
leads. Scientists at the University of Washington have teamed with
scientists from Tel Aviv University in Israel and Bethlehem University
in the Palestinian Authority to map and clone the genes responsible for
different types of inherited deafness--both progressive and early-
onset. The incidence of preverbal deafness is an estimated five to ten
percent in this region, among the highest in the world. Loss of hearing
may be due to environmental factors or to genetic mutations in any one
of a large number of genes. These genes encode proteins crucial for the
proper development, structure and function of the inner ear. There may
be more than 100 such genes, however only a fraction have been
identified. Identifying these genes and defining the mutations that
cause deafness through these novel studies will lead to a better
understanding of the biology of hearing.
conclusion
These programs and initiatives are representative of a broad
spectrum of international research and training efforts supported by
FIC. The programs of FIC recognize a deeper philosophic purpose and
vision. Advances in biology over the past decades have demonstrated
social and global interdependence. This is a condition of health for
the biosphere as much as it is an imperative of societal well-being.
There is a deepening consensus that individuals and nations share an
inherited and acquired sense of social altruism--an understanding of
common fate and a shared set of social obligations. The pursuit of
health through international scientific cooperation is an inherently
global enterprise and one that ultimately improves the public health of
this Nation as well.
The NIH budget request includes performance information required by
the Government Performance and Results Act (GPRA) of 1993. Prominent in
the performance data is NIH's first performance report, which compares
our fiscal year 1999 results to the goals in our fiscal year 1999
performance plan. As our performance measures mature and performance
trends emerge, the GPRA data will serve as indicators to support the
identification of strategies and objectives to continuously improve
programs across the NIH and the Department.
Thank you, Mr. Chairman. I will be pleased to answer any questions.
______
Prepared Statement of Dr. Donald A.B. Lindberg
Mr. Chairman and Members of the Committee: I am pleased to present
the President's non-AIDS budget for the National Library of Medicine
for fiscal year 2001, a sum of $224,942,000, which reflects an increase
of $14,806,000 over the comparable fiscal year 2000 appropriation.
Including the estimated allocation for AIDS, total support requested
for NLM is $230,135,000, an increase of $16,067,000 over the
appropriation for fiscal year 2000. Funds for the NLM's efforts in AIDS
research are included within the Office of AIDS Research budget
request.
health information for the public
In the best tradition of American enterprise, NLM has within a few
short years re-engineered its information services to benefit directly
both health professionals and the public. The public has always been
the ultimate beneficiary of NLM's services. But today's consumer now
has the same access as doctors and scientists to the Library's immense
databanks. NLM has also created new services aimed directly at the
general public that are proving popular with Web users. These changes,
encouraged by this Committee and supported by Congress, have been
endorsed by NLM's Board of Regents.
The NLM has a two-step strategy to maximize the utility of its
services. The first is to respond to the needs of the Web-using public.
It is estimated that 40 to 50 percent of Americans are connected to the
Internet, and health information is a popular topic for searching. In
three years the Library has seen the number of searches on its MEDLINE
database rise from 7 million searches a year to 250 million. The
Library estimates that 30 percent are done by the members of the public
for themselves and their families. That a database of 10 million
references and abstracts to medical journal articles would prove to be
so popular is remarkable and demonstrates an eagerness for
authoritative health information by the public.
The Library has created for consumers a new service, MEDLINEplus,
to complement its databases of scientific literature. MEDLINEplus has
grown rapidly in little more than a year, and provides links to
information on 350 diseases and medical conditions. This information,
reviewed and selected by highly trained medical librarians, originates
from such trusted sources as the Institutes of NIH and professional
societies. NLM constantly scans these and other organizations for up-
to-date information and the links are checked daily. MEDLINEplus
contains a feature unique in the world of Web-based information for the
public: carefully pre-formulated searches of the MEDLINE database that
will return references and abstracts deemed especially useful for the
average consumer.
A new service, ClinicalTrials.gov, was introduced by NLM on behalf
of NIH in February 2000. This database, accessible through MEDLINEplus,
contains vital information about thousands of clinical trials sponsored
by the NIH and other Federal agencies. Now patients, families, and
members of the public can find out about cutting-edge research being
conducted around the U.S. and whether they are eligible to join a
study. ClinicalTrials.gov contains a statement of purpose for each
clinical research study, together with the recruiting status, the
criteria for patient participation in the trial, the location of the
trial, and specific contact information. The database will be expanded
to include clinical trials sponsored by private industry and in other
countries.
Not all Americans, however, can search the Internet. Thus, NLM's
second strategy is to improve access for this group by encouraging
medical libraries to work with local public libraries and other
community organizations. In 1999 NLM completed a pilot project with
public libraries in nine states and the District of Columbia. The
purpose was to evaluate whether these libraries, using the Internet,
could help meet the needs of the public for good health information.
The project revealed that MEDLINEplus is an excellent place for
consumers to begin their search and that public librarians need
training in answering health reference questions and in finding and
evaluating health information on the Web. Building on what we learned
in this project, the NLM made awards in February 2000 to fund 49
electronic health information projects in 34 states that will increase
Internet access in many settings, from middle schools serving low
income and educationally underserved students to shopping malls and
senior centers. These imaginative and well-targeted projects will
stimulate medical libraries, local public libraries, and other
organizations to work together to provide electronic health information
services for all citizens in a community. Crucial in this effort is the
Regional Medical Libraries and members of the National Network of
Libraries of Medicine.
health disparities
The NLM has in place a number of programs that in recent years have
been directed toward remedying the disparity in health opportunities
experienced by segments of the American population. One of these
programs deals with toxic waste sites and other environmental and
occupational hazards that are much more likely to occur near homes in
poor neighborhoods than where affluent Americans live. The Library has
a program to train health professionals, community leaders, and others
in minority neighborhoods to use the NLM's databases of information
about hazardous waste information. The Library provides minority
schools with state-of-the-art equipment, software, and free access to
computerized information sources, including NLM's own toxicology and
environmental health information databases. Other Federal agencies have
joined with NLM and the project has grown from 9 participating minority
institutions to more than 60.
Similar to the program for toxicology and environmental health, the
Library has been working with institutions that serve minority
populations to encourage the use of NLM information services relating
to HIV/AIDS. These include the databases AIDSLINE (references and
abstracts), AIDSTRIALS (clinical trials), AIDSDRUGS (drugs being
tested), and DIRLINE (organizations that provide health information to
the public). The NLM has in place a program to train health
professionals, community organizers, information professionals, and
patient advocates in the use of these resources. Requests for this
training have been strong and sustained, and NLM has responded to the
extent its resources permit. In addition to the programs mentioned
above, NLM grants and contracts have been targeted to support health
information programs for African Americans, Latinos, and Native
American populations in the south; rural hospitals in the Midwest;
Native Americans in Alaska and the Pacific Northwest; African American
and Latino populations in the Pacific Southwest; and Puerto Rico. To
illustrate, telemedicine in rural Alaska is being tested as a strategy
for controlling costs and for raising the quality of health care for a
minority population that is scattered across a vast area.
The NLM is a key participant in the Multilateral Initiative on
Malaria Research effort in Sub-Saharan Africa. Scientists in many
developing countries are unable to communicate easily with other
scientists, search biomedical databases, or collaborate with colleagues
in industrialized countries. This results in poor coordination and
monitoring of research, redundancy of effort, and a growing disparity
in research productivity. The Library is supporting the implementation
of high end communications hardware and software in remote malaria
research sites in Mali, Kenya, Cameroon, Ghana, and Tanzania. Since
Internet connections can effectively carry voice, data, and video image
transmissions, the Library is helping to bring them to scientists in
those countries. The Ghana sites, for example, are engaged in malaria
vaccine development and testing readiness.
medical informatics
A recently released report recommends that the NIH invest heavily
in computer and information technology so as to be able to manage data
and model biological processes. It also observes that there is an acute
need for training specialists competent in computational biology. This
recommendation falls within the scope of the NLM's medical informatics
training program under which the Library supports 12 programs at U.S.
universities to train experts to carry out research in general
informatics and in the genome-related specialty of bioinformatics. NLM
plans to augment some of these training programs with additional
resources so that they can make use of the advantages they already
enjoy: experienced faculty, curricula, sanctioned university status,
and ready access to potential candidates. NLM envisions expanding the
program beyond 12 centers with the addition of training awards to new
institutions.
To ensure that the Internet will continue to support the health
sciences, the NLM is a strong supporter of the Next Generation Internet
(NGI), a partnership of industry, academia, and government agencies
that seeks to provide affordable, secure information delivery at rates
thousands of times faster than today. Advanced medical imaging, for
example, requires more bandwidth than is currently available. Other
applications require a guaranteed level of service (for example no data
loss, or assured privacy protection) that today's Internet cannot
provide. To help the health sciences prepare to use the capabilities
the next few years will bring, the Library is supporting the
development of innovative medical test-bed projects that demonstrate
the application and use of the capabilities of the Next Generation
Internet. Spread out over three phases, the support includes a variety
of telemedicine-related projects, advanced medical imaging, and
patient-controlled personal medical records systems. In the last phase
there will be a scale-up of especially promising projects to regional
or national level.
The Visible Human Project is an example of a program that requires
both advanced computing techniques and the capability of the Next
Generation Internet. The two very large datasets of anatomical data
represented by the Visible Human Male and Female are being used
(without charge) by 1,240 licensees in 41 countries, and at four mirror
sites in Asia and Europe. In addition to the varied uses to which these
licensees are applying the data (for example, recyclable cadavers,
virtual colonoscopies, and brain surgery rehearsal), the Library is
seeking to create a public software ``toolkit'' that will allow anyone
to use the data to ``create'' any anatomical object. A collaborative
project of the NLM, in partnership with several NIH Institutes and the
National Science Foundation, is extending the Visible Human Project by
developing an extremely detailed atlas of the head and neck.
genetics of medicine
As a result of the accelerating pace of research, the GenBank
database of DNA sequence information maintained by NLM's National
Center for Biotechnology Information is growing to gargantuan sizes. It
now contains some 5 million sequences with a total of nearly 5 billion
base pairs, and the NCBI Web site, where GenBank is made freely
available, receives some 800,000 queries per day from 120,000
scientists and others around the world. In addition to academic
institutions, major biotechnology and pharmaceutical firms are among
the heaviest users of the NCBI Web site. They not only search GenBank,
but use NCBI-created computational tools such as that which allows
researchers to use the growing body of known 3-dimensional structures
to infer approximate 3D sequence structure from similarity
relationships. NCBI scientists have also collaborated with 64
colleagues from government, university, and commercial laboratories
around the world to produce a new ``gene map'' that pinpoints the
chromosomal locations of almost half of all human genes. This milestone
in the Human Genome Project, available on the Internet, will expedite
the discovery of human disease genes and by extension, contribute to
advances in detection and treatment of illnesses.
basic services
Despite the NLM's extensive involvement with computer and
communications technology, the staff is ever mindful of its
responsibility to maintain the integrity of the world's largest
collection of medical books and journals. Increasingly, this
information is in digital form, and the NLM, as a national library
responsible for preserving the scholarly record of biomedicine, is
developing a strategy for selecting, organizing, and ensuring permanent
access to digital information. Regardless of the format in which the
materials are received, ensuring their availability for future
generations remains the Library's highest priority. The expanding NLM
collection and research and development programs continue to put
pressure on current NLM storage capacity. The issue of NLM space needs
will be considered as NIH revises its Master Plan. In the meantime, NIH
has assigned NLM space in the Natcher Building, located adjacent to the
NLM Building to address the immediate needs as longer term options are
developed and evaluated.
The NIH budget request includes the performance information
required by the Government Performance and Results Act (GPRA) of 1993.
As our performance measures mature and performance trends emerge, the
GPRA data will serve as indicators to support the identification
strategies and objectives to continuously improve programs across the
NIH and the Department.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Dr. Neal Nathanson
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the AIDS research programs of the
National Institutes of Health for fiscal year 2001, a sum of
$2,111,224,000, an increase of $105,041,000 above the comparable fiscal
year 2000 appropriation. NIH budget request includes the performance
information required by the Government Performance and Results Act
(GPRA) of 1993. Prominent in the performance data is NIH's first
performance report which compares our fiscal year 1999 results to the
goals in our fiscal year 1999 performance plan. As our performance
measures mature and performance trends emerge, the GPRA data will serve
as indicators to support the identification of strategies and
objectives to continuously improve programs across the NIH and the
Department.
The Office of AIDS Research (OAR) is responsible for setting the
scientific agenda for the large and diverse NIH AIDS research program.
To this end, we develop the annual AIDS research plan and budget, based
on the most compelling scientific priorities that will lead to better
therapies and prevention for HIV infection and AIDS. Those priorities
are established through a collaborative process involving the NIH
institutes and non-government experts from academia and industry as
well as the full participation of the AIDS-affected community.
Mr. Chairman, at our hearings here last year initiated
unprecedented attention on the international dimension of the AIDS
epidemic. Your support and attention to critical global needs at those
hearings were a catalyst for efforts that have increased throughout the
year. In January, the United Nations Security Council declared that
AIDS is now a national security issue, representing a new kind of
threat to political stability. AIDS in Africa is killing ten times as
many people as war, sabotaging economic development, leading to massive
social breakdown, and creating a generation of orphans. Ambassador
Richard Holbrooke called AIDS ``a direct, cancerous growth on the
political, social, and economic security of Africa.''
the unrelenting pandemic
By every definition, AIDS is the great plague of the 20th century--
an epidemic of biblical proportions. (Chart 1) AIDS already has killed
more than 16 million people, surpassing tuberculosis and malaria as the
leading infectious cause of death worldwide, according to recent data
from the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the
World Health Organization (WHO). In 1999, a record 2.6 million people
died from AIDS--more than in any prior year. UNAIDS estimates that in
India between 3 and 5 million people are infected, with new infections
doubling every 14 months. New epidemics are rapidly increasing in
Russia, Eastern Europe, and in China. AIDS remains a serious threat in
Latin America and the Caribbean. Africa (Chart 2) remains the epicenter
of the pandemic, bearing the largest disease burden, with 70 percent of
people living with AIDS worldwide, 83 percent of global AIDS deaths,
and 95 percent of the world's AIDS orphans. HIV-infected women aged 15
to 49 outnumber infected men. In Harare, the capital of Zimbabwe, 40
percent of adults are HIV-infected. The impact of AIDS on developing
nations and many former communist countries is staggering, with even
greater potential disaster to come. AIDS is reversing decades of
progress from important public health efforts, lowering life
expectancy, and significantly affecting international businesses. Lost
productivity and profitability, the cost of sickness and death
benefits, and the decline in a skilled workforce in the developing
world will have economic effects worldwide. AIDS is affecting the
military capabilities of some countries as well as the international
peacekeeping forces.
the evolving epidemic in the united states
In the U.S., the incidence of new AIDS cases has declined, thanks
largely to expanded use of new antiretroviral therapies that prevent
progression of HIV infection to AIDS. The previous decline in death
rates has now leveled off. The state of Illinois just announced a 24
percent increase in AIDS cases in 1999. Most significantly, the annual
incidence of new HIV infections has not declined since 1990 (Chart 3).
This means that although therapeutic interventions are delaying death,
at least for a time, we have not slowed the epidemic. Chart 4 shows
that HIV infection rates are continuing to climb in two major groups--
women and minorities. Rates are also increasing in young homosexual men
and people over 50 years of age. AIDS affects the disenfranchised in
our society--the poor, the homeless, and those with addictive or mental
disorders. Further, drug resistant strains of HIV present a serious
public health concern.
These data forebode an epidemic of even greater magnitude ahead,
and shape our most urgent research priorities. These priorities (Chart
5) address two critical populations--those living in developing
countries, and the minority populations of the U.S.--with a two-pronged
agenda: therapeutic research to treat those who are already infected;
and prevention research to reduce HIV transmission. Our prevention
agenda includes both vaccine and non-vaccine strategies, such as
behavioral research, development of topical microbicides, and
prevention of perinatal transmission.
priority: international research
We are increasing our international AIDS research porfolio. As more
than 90 percent of new infections occur in developing countries, where
therapeutic interventions are unaffordable and undeliverable, NIH is
pursuing interventions that can be implemented in these resource--and
infrastructure-deprived nations. I will cite just a few examples. A
recent NIAID-sponsored clinical trial in Uganda demonstrated that
nevirapine, an antiretroviral drug costing less than $4, given once to
the mother and once to the baby at birth, could reduce mother-to-child
transmission by 50 percent. The NIH vaccine research effort underscores
the crucial role of NIH in addressing prevention needs worldwide.
Clinical trials within both the new NIAID Vaccine Trials Network and
Prevention Trials Network are expected to involve international sites.
The OAR is supporting the first international conference on
microbicides to stimulate new research initiatives in this critical
area. To further our efforts and enhance international collaboration,
the Fogary International Center is expanding its research and training
programs in many developing nations. The OAR fiscal year 2002 annual
plan, which we are now developing, includes a special section for
international research, and we have established an International AIDS
Research Collaborating Committee to bring together all of the
Departments of the U.S. government conducting AIDS research, along with
international partners such as the UNAIDS and the World Bank.
priority: health disparities in the united states
The disproportionate impact of the HIV/AIDS epidemic on U.S.
communities of color is demonstrated graphically on Chart 6. AIDS
remains the number one cause of death among young African American men.
OAR established a new group, the Ad Hoc Working Group on Minority
Research, to advise us on the scientific priorities in this critical
research area, and we added a new section to our plan on research
targeting minorities. We are directing increased resources toward new
interventions that will have the greatest impact on these groups,
including those that address 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 we will continue to assure
the participation of minority subjects in AIDS clinical trials as well
as natural history, epidemiologic, and prevention studies. In
accordance with the Congressional Black Caucus initiative, the OAR has
provided additional funds to projects aimed at: increasing the number
of minority investigators conducting behavioral and clinical research;
targeting the links between substance abuse, sexual behaviors and HIV
infection; increasing outreach education programs targeting minority
physicians and at-risk populations; and expanding our portfolio of
population-based research. We estimate that with this budget request,
NIH will devote approximately $427 million to research targeting AIDS
in minority community communities.
priority: better therapies
The development of protease inhibitors has had a significant impact
on the length and quality of life for many HIV-infected people in the
U.S. But the news in this area is not good. At the recent scientific
meeting on retroviruses, the overriding theme was the long and serious
list of problems for patients receiving these HIV therapies, including:
(1) failure to obtain a satisfactory reduction in viral load even for
patients who comply with treatment regimens; (2) expensive and
complicated regimens that make compliance difficult; (3) drug
toxicities; (4) metabolic and cardiac complications, including
diabetes; and 5) drug resistance. We must develop and test new,
simpler, less toxic, and cheaper anti-HIV drugs. Chart 7 summarizes our
key priorities to accomplish that goal: (1) develop new targets for the
design of new antiviral drugs; (2) conduct clinical trials to answer
key questions such as: At what point in the disease process should
therapy be initiated and which combination of drugs should be used? At
what point should the drugs be switched and to which drugs? How can
toxicities and drug resistance be prevented? How can regimens be
simplified and compliance improved? and (3) translate research results
into clinical practice information that is useful to caregivers and
their patients, particularly in minority communities.
priority: hiv prevention
NIH supports a comprehensive approach to HIV prevention research
that includes contributions from the biomedical, behavioral, and social
sciences. The OAR prevention science research agenda (Chart 8) targets
interventions to both infected and uninfected at risk individuals to
reduce HIV transmission. In addition, different strategies must be
applied to each subepidemic in the US and around the world. Our
biomedical prevention research priorities include areas such as the
development of topical microbicides for women; perinatal prevention
strategies, including understanding of breast-feeding risk; and
management of sexually transmitted diseases that enhance risk of HIV
transmission. NIH also supports behavioral research strategies,
including prevention interventions related to drug and alcohol use. We
are focusing efforts on infected individuals who may not know they are
infected, but in addition, data suggest that some HIV-infected
individuals successfully responding to therapy believe that they are
less infectious and that they cannot be reinfected. As a result, they
may re-engage in risky behaviors. Thus NIH is supporting research to
develop HIV prevention interventions targeted to HIV-infected
individuals.
priority: vaccines
A safe and effective vaccine is the critical missing element in our
armamentarium. In 1997, the President challenged the nation to develop
an AIDS vaccine. Consistent with this challenge, NIH has moved forward
aggressively to build a comprehensive vaccine research enterprise.
Funds in this request represent more than a 100 percent increase in NIH
vaccine research since fiscal year 1997. These funds will provide new
grants to foster innovative HIV vaccine research and allow the
invigoration and reorganization of the NIH vaccine clinical trials
effort. The new Dale and Betty Bumpers Vaccine Research Center will be
occupied this summer. Dr. David Baltimore continues to chair the AIDS
Vaccine Research Committee which advises the NIH on the overall vaccine
program. In February 1999, NIH-supported investigators initiated the
first AIDS vaccine trial in Africa. In collaboration with industry
partners, NIH has now tested 28 different HIV vaccine candidates,
individually or in combinations, in over 3000 uninfected volunteers.
Several new vaccines, including vaccines designed to induce mucosal
immunity, novel DNA vaccines, and more complex vaccines presenting
several viral proteins, have entered phase I trials. In addition,
recent studies of ``therapeutic vaccines'' that do not prevent
infection, but can prevent or delay disease progression in animal
models has offered opportunities for additional vaccine strategies.
There have been significant incremental advances in the development
of an AIDS vaccine. A number of candidate vaccines have been formulated
for use in rhesus monkeys where they can be tested for their ability to
protect against a ``challenge'' with a simian immunodeficiency virus
that has been shown to produce AIDS in these animals. This permits the
rapid testing of the potential protective efficacy of vaccine concepts.
The left part of Chart 9 shows the blood levels of two groups of
monkeys, one vaccinated and one given a placebo control. The vaccinated
monkeys had a much reduced infection, with a much better survival than
the control group. Protection of this magnitude has been seen with
several candidate vaccines. The right part of the chart shows one of
the most recent vaccines that has been tested in humans for its ability
to produce immune responses. Both versions of the vaccine induced the
production of antibodies and cellular immune responses (CTLs), but only
in a proportion of immunized subjects. Although this was not a trial of
effectiveness, the subjects were followed for HIV infections. There
appeared to be about half as many infections in the immunized subjects,
although the numbers were too small to be statistically significant.
Results of this kind are encouraging and lead us to hope that full
scale trials of vaccine effectiveness may begin in humans in the next
few years.
benefits to other disease research
AIDS research is unraveling the mysteries surrounding many other
infectious, malignant, neurologic, autoimmune and metabolic diseases.
AIDS research has provided an entirely new paradigm for drug design and
development to treat viral infections. One example this year was the
development of the new flu drug, Relenza, which directly benefited from
AIDS research. The drug known as 3TC, developed to treat AIDS, is now
the most effective therapy for chronic hepatitis B infection. Drugs
developed to prevent and treat AIDS-associated opportunistic infections
also provide benefit to patients undergoing cancer chemotherapy or
receiving anti-transplant rejection therapy. AIDS is also providing new
understanding of the relationship between viruses and cancer.
summary
The transmissible nature of HIV--between individuals and across
borders and populations--makes it radically different from non-
transmissible diseases such as heart disease and cancer. There is the
potential for unlimited spread, and also the possibility for a dramatic
reduction in new infections--and thus ultimate control of the
pandemic--in a way that can never be possible for noninfectious
diseases. The impact of an intervention that reduces the probability of
transmission, breaking the link in the epidemic chain, extends far
beyond the treated or protected individual.
We have made enormous strides in our fight against this horrible
disease, but these were only small skirmishes in a major global war. As
this Committee clearly recognizes, our progress will be meaningless
unless we can make the benefits of our research findings available to
populations desperately in need both here in our own country and around
the world. The worldwide human and economic toll of this insidious
disease is profound, and we will never solve the problem of AIDS for
our own citizens without controlling the epidemic in the rest of the
global village. We cannot afford to leave anyone behind.
We are deeply grateful to the Committee for your steadfast support.
I would be pleased to respond to any questions you may have.
President's budget
Senator Specter. Well, thank you very much, Dr.
Kirschstein. You say you are happy to present the President's
budget. You are honored to present the President's budget.
Well, what was the increase he requested?
Dr. Kirschstein. 5.6 percent.
Senator Specter. How much of that is in dollars?
Dr. Kirschstein. The increase in dollars is $1 billion.
Senator Specter. So you are honored to present a request
for an increase of $1 billion.
Dr. Kirschstein. Yes, sir.
Senator Specter. I am just kidding with you a little here.
Dr. Kirschstein. I know.
I also said I was honored to appear before you.
Senator Specter. Would you be more honored to receive an
increase of $2.7 billion?
Dr. Kirschstein. I certainly would.
Senator Specter. I mean, if it is just a question of honor,
I want to get the issue straight.
Research Grants
What percentage of applications are recipients and grants?
Dr. Kirschstein. We will fund the largest total of research
grants we have had ever. But the percentage that we will be
funding varies between institutes, but will be an overall of
about 26 percent.
Senator Specter. Well, the percentage of grants then has
not increased in the past, say, 3 years as more than $5 billion
has been added to the NIH budget. Is that correct?
Dr. Kirschstein. It has increased somewhat over the last 3
years. It was less than the level that I gave you several years
ago.
Senator Specter. Well, I heard several years ago, 3, 4
years ago, a figure of 28 to 34 percent. And now you are saying
that there are 26 percent. And of course the question is: Are
you getting a lot more grant applications?
Dr. Kirschstein. We are getting a lot more grant
applications, but there are other reasons as well.
Senator Specter. What are those reasons?
Dr. Kirschstein. Well, in the years during which the NIH
budget was constrained, the level of funding for each
individual grant was constrained as well.
And we felt, as our funds were increased, that it would be
important for us to try to provide each investigator all of
whom are being funded to do and are doing superb work, and that
is why we are funding them, an amount of money closer to what
their peers in the review process had suggested that they are
able to use appropriately. And so we have tried to provide, as
much as possible with the increased funds, full funding for the
research grants.
In addition, we know by the way science has been changing
that it is very important to begin to provide our
investigators, and they have actually asked us, with certain
resources that are not necessarily required in each individual
grant budget: Databases; banks of nucleic acids and proteins
from which they can draw from to enhance their own research;
information systems; instrumentation; very large instruments
which they can share.
So we have used our funds not only to provide individual
investigators with the ability to do work, but provide them
with the resources that are needed.
Senator Specter. When you say that 26 percent of the
applications receive grants, can you give us an estimate, a
judgment, on how many of the balance of 74 percent which do not
receive grants are meritorious and, under ideal circumstances,
should receive grants?
Dr. Kirschstein. In the past, we considered that about one-
third of all the grants, 33, 34, 35 percent, would be an
appropriate number to strive for. However, recently the
institute directors and I have discussed this. And in many
cases, we feel that the number could go even higher, up to 40
or so percent, and meritorious science would continue to be
funded.
Senator Specter. What would it take by way of NIH budget to
fund, say, 40 percent of the applications?
Dr. Kirschstein. It would take about $2 billion more, not
quite.
Senator Specter. $2 billion on top of your current budget?
Dr. Kirschstein. Not quite, but almost.
Senator Specter. So if we come in with $2 billion more----
Dr. Kirschstein. No. $2 billion more on top of the 2000
budget.
Senator Specter. On top of the 2000 budget.
Dr. Kirschstein. Yes.
Senator Specter. The 2000 budget is right at $17.9 billion.
Dr. Kirschstein. Yes. The 2000 budget is $17.9 billion. You
are correct.
Senator Specter. So if we gave you $2 billion more, you
could increase grant of applications from 26 percent to 40
percent.
Dr. Kirschstein. Closer to one-third.
Senator Specter. Well, OK. Now answer my 40 percent
question.
Dr. Kirschstein. I think that would take more, and I am not
absolutely sure. I will try to work that out.
Senator Specter. Well, the subcommittee would like as
precise an evaluation as you can give us on how many of those
applications are meritorious. We always talk about opening up
those closed doors. And then we would like to know what it
would cost to do that.
My own sense is that the potential for medical research is
phenomenal, life saving. The most important asset we have is
our health. So we would like to know what the maximum is and
see if we cannot do something about that.
Dr. Kirschstein. Each of the institute directors has
provided information to that effect. And we will ask them to
provide even more for you. And we will try to provide it in
total.
Senator Specter. Well, maybe we will just take the time to
go around the room, giving you a little notice. And the
questions I would like to have answered are: Current budget,
what percent of the applications are granted? How many are
meritorious, would you like to grant? And what would that cost?
Sometimes we do not really get the answers later in
writing. And sometimes when we get the answers, we do not read
them.
So let us try that this morning.
I want to yield now to my distinguished ranking member,
Senator Tom Harkin.
In your absence, I was saying good things behind your back,
Tom. So beware.
Senator Harkin. I have to be careful about that now.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Thank you very much, Mr. Chairman. And
thank you for your great leadership on this committee, but
especially as it deals with NIH funding. I was proud to join
you last year in your great effort to secure a historic
increase for NIH. And I am proud to join you again this year,
hopefully for another historic increase in NIH funding.
I also want to thank Dr. Kirschstein for her leadership at
NIH, for always being there when we needed someone to take the
helm, especially one--as I figure, you have been there 44
years.
Dr. Kirschstein. That is correct.
Senator Harkin. And I want to thank you for 44 years of
service to our country and beyond that, I guess, service to all
humankind in terms of biomedical research. I think you are a
great example, I hope, to a lot of young people today as to
what research affords and what it can mean in terms of
contributions they could make, if they were to stay in
research.
That is one of the reasons that I hope that we can continue
to increase this funding for NIH and get it doubled in 5 years,
as Chairman Specter has set the course to do, and that is to
let a lot of young people know today that they can have a
career in research, a good career in research.
So I compliment you for that and, through you, to all of
the institute directors who are here today and to thank each
one of them, each one of you, for all of your work and your
leadership in the area of medical research.
prepared statement
With that, I would just ask that my statement be made a
part of the record, Mr. Chairman.
Senator Specter. It will be made a part of the record
without objection.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
Mr Chairman, I want to thank you for holding this hearing today and
I want to welcome Dr. Kirschstein and her colleagues from NIH who are
testifying before us today. NIH is the premier medical research
institution in the world--research funded by NIH is key to maintaining
the quality of our health care and key to finding preventive measures,
cures and the most cost effective treatments for the major illnesses
and conditions that strike Americans.
But I must say that the timing of this hearing is interesting.
Yesterday, the Senate Budget Committee marked up a budget resolution
that cuts nondefense discretionary spending from last year. Nondefense
discretionary spending is cut by $7 billion from a freeze! Last year,
this subcommittee was able to secure a $2.3 billion increase for NIH--
the second year in an effort to double NIH funding over five years. Mr.
Chairman, as you know, you and I introduced legislation earlier this
year calling for a $2.7 billion increase for NIH in fiscal year 2001--
building on last year's increase for NIH as we move to doubling funding
for NIH over a five-year period.
But, it is going to be next to impossible to find that money with a
cut in our allocation this year. But, Mr. Chairman, I know you will
find a way--it's times like this that I'm glad you are the Chairman.
One, but certainly not the only, reason that we must continue this
support for medical research at NIH is the truly awe-inspiring
potential benefits of stem cell research. This Subcommittee has held a
number of hearings on the issues surrounding stem cell research. At
those hearings, I have had the opportunity to express my support for
this research. Now it is time to move forward. Dr. Kirschstein, I
understand that the comment period has closed on the stem cell research
guidelines--I expect that you will keep me updated on how you intend to
encourage and support quality, ethically-sound research in this area
over the coming months.
I am also excited about the progress made on the Human Genome
project. I see from Dr. Collins' testimony that scientists will
complete the human genome sequence in 2003, two years ahead of the
original schedule. I really believe that effort will results in a
number of scientific breakthroughs in over the next ten years.
Thank you, Mr. Chairman--I look forward from hearing from our
witnesses.
Senator Harkin. I do have several questions. I hope we have
another round, because I am not going to get them all in in 5
minutes, Mr. Chairman.
Senator Specter. Sure.
Stem Cell Research
Senator Harkin. There are about three areas I want to
cover. One is stem cells. I want to cover Francis Collins with
the genome research. And the other one is with the National
Institute of Drug Abuse, NIDA, on methamphetamine. And maybe
one other question on complementary and alternative medicine.
Those are basically the areas I want to cover.
Let us start with stem cells first, Dr. Kirschstein. I
understand that NIH has issued draft guidelines for the funding
of stem cell research. And the comment period on those
guidelines ended on February 22.
Can you give us some idea of when you will be finished
reviewing those comments and be ready to issue a final
regulation? And do you think there will be any changes to the
proposed guidelines?
Dr. Kirschstein. Mr. Harkin, first of all, thank you for
your very kind remarks.
The comment period, as you said, did close on February 22.
And the staff is working very hard now to analyze all the
comments--there were a considerable number--and to decide what
needs to be changed about the guidelines. They will be revised.
And we are working on that at the present time.
In addition, once the guidelines are published, we also
want to have an oversight group in place to be able to review
all the proposals related to the use of stem cells.
And so what we propose is that we put out the final
guidelines at the same time as we have such an oversight group
in place. And then we would be ready to go. We would anticipate
doing so sometime in the early summer.
Senator Harkin. Well, I am a little--I appreciate the time
frame. Early summer, I hope that means--when does summer start,
in June? June 21.
But I am a little concerned about what I thought I heard
you say, and that is that there would be some revisions to the
proposed guidelines. And that has raised my level of concern.
Dr. Kirschstein. No. The revision is based on the comments
and what we think are in the comments that could clarify and
refine what the guidelines will say. The basic aspects of the
guidelines will remain the same.
Stem Cell Research and Diabetes
Senator Harkin. OK. I appreciate that. Then my concern has
been alleviated.
I understand that at the University of Alberta in Edmonton
seven individuals with juvenile diabetes have remained free of
insulin injections for close to a year after receiving
transplants of insulin-producing cells.
I use that only as an example, but how does NIH plan to
capitalize on this potential breakthrough? And what role might
stem cells play in the future of this kind of research?
Dr. Kirschstein. Senator Harkin, if I may, I would like to
ask Dr. Spiegel, the new director of the National Institute of
Diabetes, Digestive and Kidney Diseases, to answer that
question.
Senator Harkin. That would be great.
Dr. Spiegel. Thank you, Dr. Kirschstein.
The protocol you referred to, Mr. Harkin, the Edmonton
Protocol, has indeed been successful for this period of 1 year.
In collaboration with the National Institute of Allergy and
Infectious Diseases' Immune Tolerance Network, that protocol
will be expanded to multiple centers, which in turn hope to
derive the islets that need to be produced at the NCRR harvest
centers. NIDDK has also funded about $3.5 million worth of new
trials on other protocols for islets transplants.
As far as stem cells are concerned, it is clear that if
this is, as we hope, successful, there will be a tremendous
need for additional sources of insulin-secreting beta cells.
Recent work in mice, published in Nature, indicated that
one can harvest such stem cells from the pancreas and that they
can cure diabetes. We will have a workshop of stem cell experts
on April 10 through 11, which will explore all the possible
avenues.
And we are optimistic that there will be real opportunities
for breakthroughs that will bring these clinically exciting
trials, as well as stem cell technology, together.
Senator Harkin. Can you elaborate a little bit more? This
has been one year that they have. Is there any indication that
there is any kind of rejection or that they may have to fall
back on insulin injections? What can you enlighten me about the
present state of that protocol?
Dr. Spiegel. I would like to put it in historical
perspective. Dr. Lacey at Washington University was a pioneer
in this area and over 20 years ago made the first attempts at
islet transplants in humans.
Unfortunately, only perhaps 1 out of 300-and-some-odd
patients in the world remained insulin independent after
treatment. So there were dismal failures up to now. This is why
this is so promising.
And it relates both to the better methods of harvesting the
islets from donor pancreases, as well as novel techniques which
derive from basic immunology research. They are using a
monoclonal antibody that targets a particular T-cell receptor
and a drug called Rapimycin.
Now, unfortunately, this is still not what we want to
achieve. We would like to achieve complete absence of
immunosuppressive drugs, be able to have the patient treated
during the transplant and then need no further medication. And
indeed, there are studies both in mice and in nonhuman primates
indicating this can be achieved.
Currently, these individuals in Edmonton have not had their
medications removed. So it is too early to tell if they will be
able to achieve a state of immune tolerance. But we are very
optimistic that that could be the case.
Senator Specter. Let us return to this in just a moment,
because Senator Cochran has to chair another hearing. And we
want to hear from him.
OPENING STATEMENT OF SENATOR THAD COCHRAN
Senator Cochran. Well, thank you very much, Mr. Chairman. I
want to join you in welcoming Dr. Kirschstein and the directors
of the NIH who are appearing here today. It is good to see Dr.
Klausner and to thank him for his trip to my State.
I appreciate what Dr. Kirschstein and the NIH do for our
Nation's health. The NIH has excelled in the stimulation and
support of medical research. Their efforts have involved both
the basic scientific research needed to understand disease and
treatment, and the translational research needed to support
clinical practice, and to reach the ultimate goal of improving
the treatment of, and achieving the prevention of disease.
prepared statement
There are other comments that I have prepared as an opening
statement and some questions, which I ask, Mr. Chairman, be
printed in the record and submitted for answering for the
record. And I apologize for having to go to chair another
meeting and not being able to stay for the full period of this
hearing.
Thank you all for what you do.
Senator Specter. Well, Senator Cochran, thank you very much
for joining us. We know you are chairing another hearing. And
your full statement and questions will be in the record and
submitted for responses. Thank you.
[The statement follows:]
Prepared Statement of Senator Thad Cochran
Mr. Chairman, I want to thank Dr. Kirschstein and the directors of
the NIH's institutes for appearing here today. It is good to see Dr.
Klausner and thank him for his trip to my state. I what all of you do
for our nation's health. The NIH has excelled in the stimulation and
support of medical research. Their efforts have involved both the basic
scientific research needed to understand disease and treatment, and the
translational research needed to support clinical practice, and to
reach the ultimate goal of improving the treatment of and achieving the
prevention of disease.
The NIH has invested in the future of our nation's health by
addressing areas of need including chronic diseases and health outcome
disparities among minorities, those who live in rural communities and
other under served populations. Some of these initiatives have taken
place in Mississippi. The NIH continues to invest in the Jackson Heart
Study, one of most significant cardiovascular studies of the African-
American population.
I am also very interested the ongoing efforts of NIH to increase
opportunity and expand funding for projects like the Jackson Heart
Study, in states such as Mississippi, that have not been traditional
NIH research centers and that have lacked NIH research funding are also
the areas with a high prevalence of chronic diseases.
I applaud the efforts of NIH to address not only the issues of
today, but also the issues of tomorrow. Only through foresight and
planning can we avert the epidemics of the future. For example, the NIH
has been alert to problems such as infectious disease research and the
growing problem of antimicrobial resistance.
NIH has also had the foresight to address diseases that are
sometimes overlooked. One of those areas is Parkinson's Disease, a
disease sometimes overshadowed by other more high profile diseases. In
fact, I am hosting a briefing next week to support the National
Institute of Neurological Disorders and Stroke strategic plan to
develop a cure for Parkinson's.
I appreciate your efforts in each of these areas. I look forward to
assisting you as you continue your important work.
Senator Specter. Senator Feinstein.
Senator Feinstein. Thank you very much, Mr. Chairman.
And I would like to say welcome to all of you.
Particularly for Dr. Klausner, you know this last year on
the National Cancer Dialogue has been very interesting to me.
And I have learned a great deal.
I have a statement, if I may, Mr. Chairman, to be entered
into the record.
Senator Specter. Without objection, it will be made a part
of the record in full.
Senator Feinstein. Thanks very much.
[The statement follows:]
Prepared Statement of Senator Dianne Feinstein
Thank you, Mr. Chairman, for holding this important hearing.
The American people put a great deal of hope and faith in the
National Institutes of Health. NIH is truly a symbol of our national
strength and the world's leading medical research institution. NIH has
produced 93 Nobel Prize winners and I come from a state that has world-
renowned research entities that work closely with NIH.
I have been pleased to work with NIH and this subcommittee to
increase NIH funding in recent years, including the 15 percent increase
we were able to provide each year for the past two years. It is a sad
commentary that NIH can only fund around 32 percent of grant
applications. Fortunately, that ``success rate'' has gone up since 1994
when it was only 25 percent, but still, the many unfunded grants leaves
a vast wealth of scientific knowledge unexplored and hundreds, if not
thousands of diseases and disorders, uncured or untreated.
The challenges facing our nation are huge.
--By 2010, the incidence of cancer will reach ``staggering
proportions,'' with an increase of 29 percent in incidence and
25 percent in deaths, at a cost of over $200 billion per year.
-- AIDS is now the leading cause of death among Americans ages 25 to
44.
--Rates of diabetes and asthma are rising.
--Seven to 10 percent of children are learning disabled. Forty
thousand babies die each year from devastating diseases.
--Our aging population presents formidable challenges, from
understanding overwhelming diseases like Alzheimers to helping
people have quality of life as they have a longer life.
I am sure the decision to fund one area means not funding another
and that NIH decision-makers must feel pulled in every direction.
cancer challenges
As a co-chair of the Senate Cancer Coalition, I have been working
closely with the national cancer community for several years and would
like today to raise some of the concerns that are brought to my
attention. I hope everyone will understand that these are not intended
as criticism of NIH or any institute or individual, but are challenges
for our nation as identified by experts.
The Discovery to Delivery Disconnect.--Dr. Harold Freeman, Chairman
of the President's Cancer Panel, on March 8 made a presentation in
which he expressed his concerns about a disconnect between the fruits
of research and routine medical practice. He explained that we have
made great strides in understanding disease origins, but said we must
do better in incorporating research findings into routine practice. Can
we do better? If so, how?
The National Cancer Institute is a research institution. It is not
a HCFA or Medicare or health care delivery agency. It was never
designed to be a delivery system for health care. Even so, can't we do
better in connecting this disconnect?
The Unequal Burden of Cancer.--The Institute of Medicine last year
issued a report on disparities in cancer care concluding, ``Despite
scientific gains, not all segments of the U.S. population have
benefitted to the fullest extent from advances in the understanding of
cancer.'' In October, the New England Journal of Medicine reported on a
study of 11,000 lung cancer patients which found that blacks are less
likely than whites to get surgery for early stages of lung cancer. The
study ruled out reasons like socioeconomic status, insurance, and
access to care and implied that the reason could be a breakdown in the
doctor-patient relationship.
Unevenness of Cancer Care.--The Institute of Medicine also reported
last year that ``there is a wide gulf between what could be construed
as the ideal and the reality'' of cancer care, that some patients do
not get care that is proven to be effective and the problem is
``substantial.'' The study said that having health insurance improves
access, but it does not guarantee good care.
The Declining Investigator ``Pipeline.''--The number of physician-
scientists in oncology is diminishing at a time when knowledge and
discovery are expanding rapidly. Funding at NCI for investigator
training was only 3.1 percent of NCI's budget in 1999. The number of
postdoctoral M.D. trainees in all fields funded by NIH overall has
declined 51 percent of 6 years according to a study in Science. This is
exacerbated by the growth in managed care plans that do not contract
with academic medical centers where the bulk of research and training
are conducted.
``This tragic phenomenon is jeopardizing the future of cancer
research discovery and translation and the future of an America in
which cancer is a treatable, beatable disease,'' says the National
Coalition for Cancer Research.
The Salary Cap.--Since the early 1990s, Congress has placed a
``salary cap'' on extramural researchers, those scientists in
laboratories, like the University of California. The cap is a top
salary limit of $141,300, even though senior scientists on the NIH
Bethesda campus can earn up to $157,000. This cap has the effect of
driving talented researchers to the private sector. We should be trying
to attract and retain talented researchers to our universities, not
create incentives that drive them away.
Clinical Trials.--Only two percent of cancer patients are enrolled
in clinical trials and of those, only 25 percent are elderly, even
though cancer is disproportionately a disease of aging and the median
age of cancer diagnosis is 68, according to the Cancer March of 1998.
Last year, this committee asked NIH to send us a report on identifying
barriers to participation in trials and recommendations for eliminating
barriers. I hope you have good news for us today on that report.
The American people have said they would contribute another $1.00
per week in taxes for medical research. The public is behind NIH. This
is indeed encouraging and I pledge to help NIH meet the many medical
challenges that face our society.
I look forward to working with you to address these challenges to
improve the health and quality of life of millions of Americans.
Bench to Bedside Application
Senator Feinstein. One of the things that I have become
increasingly concerned about is the kind of disconnect that
exists between discovery and application from the laboratory to
the bedside. Some say it takes 5 years to get from a mouse to a
human.
Somebody you know well, Dr. Helene Brown of the UCLA Cancer
Center, points out that the pap smear was ready for widespread
use in 1940, but was not really used until 1960. 20,000 women's
lives a year were unnecessarily claimed over the 20 years of
this delay.
My first question to any who care to answer is: How can we
shorten this disconnect? How can we get things from the
laboratory to the patient more quickly?
Dr. Kirschstein. I think Dr. Klausner will start.
Dr. Klausner. Thank you.
First of all, Senator Feinstein, I want to thank you for
your leadership in the bringing together of the disparate
components of the cancer community. You have been very helpful.
Senator Feinstein. It has been interesting.
Dr. Klausner. I think--while I can comment about some NCI
programs, I think one of the characteristic changes of the last
few years has been an acceleration of translation of basic
research into the clinic. Now the speed with which that happens
varies tremendously, depending upon what it is you are trying
to translate.
For example, the discovery of a genetic alteration that
predisposes an individual to a particular disease, for example
cancer, can translate rapidly into a useful and useable
clinical test.
In my own work with a tumor suppressor gene for
predisposing an individual to kidney cancer, it took about a
year from discovery for it to be widely used in clinics to help
predict predisposition and to help families make decisions
about surveillance and what to do about this particular
predisposition syndrome.
For the development of new therapies, it often takes a long
time. But I think many of the programs that have been developed
with the new funding over the last few years are actually being
developed to speed that transition.
Let me give you an example. We established a program about
a year and a half ago called RAID for Rapid Access to
Interventional Development. It is sort of a virtual national
drug development system that reaches out to academic
laboratories and funds new promising agents to move, we hope,
within 12 months out of the laboratory into phase one clinical
trials. And this is really very rapid.
We have now a little over a year's experience with the
program. Thirty-two novel agents have been funded. Four of them
have actually already made it out of the laboratory, basic
laboratories, into clinical trials, each costing less than
about $1 million per drug.
It is these sorts of programs that allow us to move things
much more rapidly than we had before. And I think there are
many other examples that all of us can give.
But I think it really is a characteristic of the new
technologies and new programs we are all developing that are
aimed specifically at speeding that transition.
state of Cancer Care
Senator Feinstein. Second question--and I thank you for
that. And I think you yourself pointed out the amazing
extension of life that has been achieved through the pediatric
model with cancer, where a child with cancer can in fact really
be assured throughout the Nation of state-of-the-art cancer
care. The same is not true for an adult.
And what we have found is that the state of cancer care
throughout the Nation is extraordinarily erratic. The need for
every cancer patient to have a quarterback physician, for
example, I think preferably an oncologist, somebody who is able
to go through the options with them, see that for their case
they have the best possible options, there is no real state-of-
the-art care for the adult cancer patient.
What is the institute doing to try to bring that about? And
how might we be helpful in that regard?
Dr. Klausner. Yes. I see the red light is on. Do I have
time to answer this?
Senator Specter. Yes, Dr. Klausner.
Dr. Klausner. Thank you.
Well, Senator, you are right. I think pediatric oncology,
again, is one of the real success stories of NIH, of actually
linking research to practice.
Sixty-five percent of children in this country who are
diagnosed with cancer, regardless of their economic status or
ethnicity or race, are treated on NCI-funded clinical trials.
And 90-odd percent are treated on NCI-developed protocols. When
I say NCI, I mean the protocols are not developed by the
institute, but by our funded investigators. This is as opposed
to 2 to 3 percent of adults being treated on NCI-funded
clinical trials.
We believe that part of the reason there has been such
progress in cure rates for childhood leukemia and childhood
cancers, even without the development of major new drug
advances, is due to improving protocols.
One of the things that we have been doing to try to expand
this to the adult is to revamp our clinical trial system, to
turn it into a truly national system with a single web-based
informative structure that allows any physician to access any
of the 1,500 open adult clinical trials that we have in the
country. This is new and is just coming on line this summer
with a new national clinical trials organizational unit.
But there is a lot that we need to do to try to open this.
Funding is limited but with recent increased funding, there has
been a significant increase in accrual just this past year of
adult patients to clinical trials.
What does that mean? One example, in a recent adjuvant
breast cancer trial, it was predicted to take 38 months just to
finish the accrual. It took 14 months. That means we can ask
more questions more quickly. It is a direct reflection of the
funding.
There are other issues, and that is whether patients have
access to clinical trials; the issue of whether, for the
clinical care associated with clinical trials, patients can
obtain reimbursement.
Senator Feinstein. Can I just quickly----
Dr. Klausner. Yes.
Senator Feinstein. Are you saying then that the only way to
assure that every cancer patient in the United States has
state-of-the-art care is by access to clinical trials?
Dr. Klausner. No. I am sorry.
Senator Specter. Dr. Klausner, you may answer that, but
please do so briefly.
Dr. Klausner. I do not think that is the only way, but I do
think we need to expand the clinical trials to generate more
answers more quickly.
And I think there is a variety of ways that we can make
sure that the results of the clinical trials and the protocols
that are generated, the expert protocols by which patients are
treated on clinical trials, are more disseminated, whether it
was within or without a clinical trial.
Senator Feinstein. OK.
[The information follows:]
Stem Cell Research
As an introduction to the answers from the individual Institute and
Center Directors, I would state that the potential scientific and
medical benefits that may result from research using human pluripotent
stem cells, funding and oversight of human pluripotent stem cell
research by the Federal Government has become increasingly important.
The participation of government in this research will help ensure that
any research utilizing human pluripotent stem cells is conducted within
the federal regulations and very importantly, that the results will be
accessible to the public. If pluripotent stem cells are available to
researchers, we expect that scientists will be able to pursue important
research in the areas described below.
national cancer institute
Since stem cells have the ability to divide without limit and give
rise to many specialized cells in an organism, there are several
reasons why may be important to cancer research and to reducing the
cancer burden. First, pluripotent stem cells may be used to treat the
tissue toxicity brought on by cancer therapy. Bone marrow and
peripheral blood multipotent stem cells (which are more committed stem
cells) are used already to restore patients' hematopoietic and immune
systems after high dose chemotherapy. Pluripotent stem cells may have
greater potential for returning the complete repertoire of immune
response to patients undergoing bone marrow transplantation, thus
contributing to the development of other treatments such as immune/
vaccine therapy. Other tissues damaged by cancer therapy also may
benefit by replenishing their stem cell pools, e.g., injection of
pluripotent stem cells into the heart may permanently reverse
cardiomyopathy caused by certain chemotherapeutic agents; injection of
pluripotent stem cells that have been differentiated into neural cells
may restore brain function after cancer treatment.
A second reason why stem cells may be important to cancer research
is based on the finding that cancer cells may have certain stem cell
properties, specifically, the ability to renew themselves. The
isolation and characterization of stem cells and in depth study of
their molecular and cellular biology may help scientists understand why
cancer cells survive despite very aggressive treatments. Once the
cancer cell's ability to renew itself is understood, scientists can
develop strategies for circumventing this property.
A third and final reason for studying stem cells lies in the field
of gene therapy, by which a gene that provides a missing or necessary
protein is introduced into an organ for a therapeutic effect. One of
the most difficult problems in gene therapy studies has been the loss
of expression (or insufficient expression) following introduction of
the gene into more differentiated cells.
Introduction of the gene into stem cells to achieve sufficient long
term expression would be a major advance. In addition, the stem cell is
clearly a more versatile target cell for gene therapy, since it can be
manipulated to become theoretically any tissue. A single gene transfer
into a pluripotent stem cell could enable scientists to generate stem
cells for blood, skin, liver, or even brain targets. Applications to
cancer might include engineering replacement cells that are resistant
to chemotherapeutic assault or that express antibodies against cancer
targets.
national heart, lung, and blood institute
Research using human pluripotent stem cells represents an important
opportunity to understand numerous processes in human biology and
provides enormous potential for designing new therapies and screening
candidate drugs for various diseases. Establishment of human
pluripotent stem cell lines for the characterization of the biological
properties and markers of stem cells will allow us to identify various
stem cell populations and develop models/assays to predict successful
replacement of tissue in disease or traumatic injury settings. The
identification of factors that control these important processes holds
great promise to ultimately treat numerous diseases that result in
human suffering.
national institute of dental and craniofacial research
The results from using pluripotential stem cells are enormously
important towards developing innovative solutions to complex human
diseases such as Parkinson's disease and a number of chronic pain
syndromes. The capacity for pluripotential stem cells to differentiate
into many different cell types is remarkable and has opened scientific
inquiry into a number of approaches to regenerate damaged neural and
muscular tissues. In addition, stem cell biology in general has opened
new approaches for a number of therapeutic challenges such as soft and
hard tissue regeneration. For example, mesenchymal stem cells found in
bone marrow are being used to treat human bone diseases such as McCune-
Albright syndrome here at the NIH.
These benefits are but a superficial glance at the possibilities
for both pluripotential as well as totipotential stem cell biology. The
scientific foundations are being established and we need critical
support to rapidly advance our basic science of stem cell biology into
preclinical and clinical trials to address the significant suffering of
so many American people. Stem cell therapies could profoundly reduce
the burden of many dental and craniofacial diseases and disorders such
as cleft lip and cleft palate, oral and pharyngeal cancer, and a number
of chronic facial pain syndromes. In addition, pluripotential and
totipotential stem cell research will also produce specialized cells
such as cartilage and salivary cells, which can be used as replacement
for tissues damaged by disease or injury. Examples include the
treatment of temporomandibular joint disorders (TMDs), the replacement
of skeletal elements lacking or damaged in diseases such as fibrous
dysplasia of bone, the use of cells grown in special natural or
synthetic scaffolding materials, and the replacement of salivary cells
damaged by autoimmune diseases (Sjogren's Syndrome) or radiation for
head and neck cancer.
national institute of diabetes and digestive and kidney diseases
Human embryonic stem cells hold great promise for advances in
health care because they can give rise to many different types of
specialized cells that may be used to replace or repair damaged tissues
and organs and for other therapeutic purposes. They can also be used to
enhance the development of new medications to slow or arrest disease
processes, and to aid fundamental research that can provide important
insights into developmental processes important to the understanding,
treatment and ultimate prevention of disease. These ``pluripotent''
cells have the unique capability of limitless division and self-
renewal, and thus can be maintained indefinitely in cell culture.
Human embryonic stem cells offer the potential for treating a
number of chronic diseases that are within the NIDDK research mission.
For example:
Type 1 Diabetes.--There is an intense effort under way to
understand the genetic rules by which an undifferentiated cell becomes
a beta cell of the islet of the pancreas, which is capable of secreting
insulin. Human embryonic pluripotent stem cells offer great hope for
providing an unlimited supply of insulin-producing cells for
transplantation once the rules of differentiation are known.
Liver Diseases.--Attempts at cellular therapy to replace diseased
liver tissue are under way. In this case, a cell would need to
differentiate along the lines of a functional liver cell. Again, a
similar set of rules are necessary for this to happen, but again the
plasticity of the human pluripotent stem cell would form an excellent
base for this to occur.
Kidney and Bladder Diseases.--Various forms of kidney cells or
potential bladder cells also offer the potential to differentiate into
highly important tissue specific cells. At the present time, there are
a number of studies underway in an attempt to grow bladder cells that
could be used to reconstruct a human bladder.
Developmental Biology.--There are other examples in addition to
diabetes, liver failure, kidney failure, and urologic diseases in which
human pluripotent stem cells may have a major therapeutic role. It
would also be important to try and understand the genetic rules of
development so that these important cells may be applied to important
therapeutic uses.
national institute of allergy and infectious diseases
Transplantation.--Research on embryonic stem cells could lead to
cures for diseases that require treatment through transplantation,
including autoimmune diseases such as multiple sclerosis, rheumatoid
arthritis, systemic lupus erythematosus, and type-1 diabetes.
The most feasible example in the short term is to treat type-1
diabetes by transplanting pancreatic islet cells or beta cells produced
from autologous embryonic stem cells--that is embryonic stem cells that
are removed from an individual, differentiated ex vivo to become
functioning islets or beta cells, and then transplanted back into the
same individual. Although there are questions about our ability to
identify stem cells, obtain them in sufficient numbers from older
children or adults, and produce differentiated cells, tissues or organs
from such stem cells, this technique holds great promise to cure
disease. Autologous transplants would obviate the need for
immunosuppressive agents in transplantation, reduce the risks of
transmitting infectious agents within transplanted materials, and
eliminate the risks of post-transplant infection due to global immuno
suppression. Moreover, such embryonic stem cells might be used to
create a myriad of transplantable cells, tissues, and organs. This
would address problems ranging from the supply of donor organs to the
difficulty of finding acceptable matches between donors and recipients.
Primary Immunodeficiency Diseases.--Embryonic stem cells might be
used to treat virtually all primary immunodeficiencies. There are more
than 70 different forms of primary (congenital and inherited)
deficiencies of the immune system, which are characterized by an
unusual susceptibility to infection and are sometimes associated with
anemia, arthritis, malabsorption and diarrhea, and certain
malignancies. Almost all of these diseases are rare, and can involve
considerable pain and suffering, numerous hospitalizations, high
medical costs, and even death. Because these diseases are genetic, gene
replacement is an important area of investigation in the search for an
effective treatment. Transplanting stem cells that have been
reconstituted with a normal gene might result in developing healthy
cells of the types affected by the missing or damaged genetic material
in the immunodeficiency disease. Based on research with animals, there
is reason to believe that using embryonic stem cells as a mechanism to
replace damaged or missing genes will have proliferative advantages
over currently available alternatives, such as peripheral blood or bone
marrow derived hematopoietic stem cells. Other hypothetical advantages
include greater susceptibility to genetic transduction. Ultimately, the
hope is for greater success in transplantation, long-term survival and
reconstitution of normal cellular functions.
HIV/AIDS.--Research on pluripotent embryonic stem cell transplants
could make restoration of immune function a viable option for treating
HIV disease. Such transplants could regenerate all the components of
the immune system that have been damaged by HIV infection. This
includes repairing HIV-induced damage done to the cells and tissues
that support immune system development, which would be a required
prerequisite for T-cell repopulation. While there are many questions to
be answered, experiments in animal models point to significant
advantages with the use of these cells. Primarily, the embryonic stem
cells are easily transduced with new genetic material, such as anti-HIV
genes, so that the daughter cells are resistant to HIV infection. Thus,
this combination of gene therapy and stem cell research could result in
the immune reconstitution of AIDS patients with cells that are
resistant to HIV.
national institute of neurological disorders and stroke
The logic arguing for NIH funding of embryonic stem cell research
is straightforward from the perspective of nervous system disorders.
Put simply: (1) Stem cells have enormous potential for treating
disorders of the nervous system. (2) Research on embryonic cells is
necessary to realize these possibilities.
To elaborate:
1. Stem cells have enormous potential for treating neurological
disorders. The wide range of possibilities arises because these
versatile cells can be used in several different ways. Plausible
applications of neural stem cells include replacing lost nerve cells,
replacing glial (supporting) cells, restoring complex nervous tissue,
supplying cell sustaining chemicals, delivering substances widely
throughout the brain, serving in tests for drug screening, and
advancing fundamental studies of the brain and brain development.
Although much research is needed before human trials can be safely
attempted, animal experiments have already begun to demonstrate the
feasibility of stem cell strategies for Parkinson's disease, spinal
cord injury, demyelinating diseases such as multiple sclerosis, and
enzyme deficiency disorders such as Tay-Sachs. Stem cell based
strategies have also been proposed for several other neurological
disorders such as stroke, epilepsy and brain tumors.
2. Embryonic stem cells are necessary to realize these
possibilities. Although stem cells are present in adult brains, the
adult stem cells may not have the versatility of their embryonic
counterparts. There is experimental data showing that embryonic stem
cells can produce not only many types of neural cells, but also muscle,
blood, bone, and other tissue. There is strong evidence that embryonic
cells can survive when transplanted and can migrate widely in the adult
brain. Embryonic stem cells have the potential to divide for indefinite
periods in culture and offer the possibility of a renewable source of
replacement cells and tissue, but stem cells in the adult brain are
characterized by limited availability and accessibility. Therefore,
research on all types of stem cells must be done to compare their
properties and find those most suitable for each of the several
different potential therapeutic applications.
national institute of general medical sciences
Studies of embryonic stem cells would speed important medical
advances. For example, NIGMS has supported research devoted to the
development of ``artificial skin.'' Such a biomaterial would enjoy wide
application in the field of burn therapy. Initial studies, begun in the
early 1980s, has led to the development of a model for cultivating skin
cells from burn patients. The method, which is being tested in patients
today, consists of combining a biopolymer sponge made of collagen with
actual skin cells from burn patients. Conceivably, human pluripotent
stem cells could also be used as a source of ``skin'' to build such a
graft, especially for severely burned patients with limiting amounts of
remaining intact skin.
national institute of child health and human development
The fundamental question in biology is how a single fertilized egg
develops into a complex adult organism with many different specialized
cell types performing specific functions. This development follows a
program directed by precisely timed turning on and off of many genes.
Learning how this process works is basic to the mission of NICHD in
promoting the birth of healthy offspring through research on human
reproduction and development. Since pluripotent stem cells can develop
into many different cell types, the study of how pluripotent stem cells
can develop into many cell types may provide new knowledge of how
fertilized eggs develop into organisms. Also pluripotent stem cell
research will allow scientists to, among other things, direct the
development of these stem cells along a certain path to become liver,
blood, brain, or any type of cells which then can be used in
transplantation and for other purposes. Within NICHD's area of
interest, these cells could be used to replace organs or tissues that
are defective as a consequence of birth defects. For example, one such
condition is biliary atresia, in which part of the liver does not
develop correctly. Human embryonic stem cells could potentially be
directed to form liver tissue or to replace the damaged organ and save
the life of the affected infant.
national eye institute
Research into the treatment of retinal degenerations has
demonstrated some promising results by transplanting retinal cells and
tissues in an effort to ``treat'' animal models of retinal
degeneration. However, the results have been mixed and many questions
remain. The immunologic issues governing transplant survival are
complex and only partially understood. Possible strategies for
overcoming these problems are suggested from ongoing investigations of
the development and maturation of the normal retina. Use of pluripotent
stem cells could provide an additional avenue of research to overcome
the immunological or other potential problems that may be encountered.
There is also a significant clinical need for improved techniques
to promote conjunctival and corneal healing during disease or after
injury. Conventional surgery or standard corneal transplantation
procedures are not consistently successful in treating persistent
corneal ulcers, chemical or thermal injury, and other diseases that
damage or scar the cornea. Recent results involving transplantation of
corneal ``stem'' cells from the limbus region have shown some promise,
but many practical and technical problems are presented by this
approach. Transplantation procedures with pluripotent stem cells could
provide an additional avenue of research for facilitating
epithelialization of the ocular surface, reducing inflammation,
vascularization, and scarring.
national institute of environmental health sciences
Human pluripotent stem cell research offers powerful new research
approaches for clarifying the complex association of environmental
agents with human disease processes. It also makes possible a powerful
new means of conducting detailed investigations of the underlying
mechanisms of the effects of environmental chemicals or mixtures of
chemicals. The use of human pluripotent stem cell cultures may allow
the identification of the specific early cell types at greatest risk of
adverse effects from exposure to such developmental toxicants as lead,
mercury, and polychlorinated biphenyls, as well as the mechanism of the
toxic effect(s) and the temporal nature of future adverse effects in
the subsequent cells and tissues established from these stem cells.
There are often subtle effects of toxic exposures on the developing
embryonic and fetal development tissue systems, yet these systems are
responsible for maintaining strong post-natal health. For example, the
human embryo and fetus may be very susceptible to long-terms
impairments of immune or nervous system functions from the in utero
effects of toxicant exposure.
Parkinson's disease, according to most recent findings, has a
strong component related to environmental exposure component for one
form of the disease. The nature of the agents and the timing of the
exposure remain unknown at present. The use of human pluripotent stem
cell cultures will permit screening for the subtle effects of candidate
environmental toxicants and toxicant mixtures on specific cell types in
the developmental stages of the cell lineage comprising the nervous
system cells and tissue associated with the brain region compromised by
the disease. Such explorations may yield powerful insight into the
biological mechanism(s) underlying human susceptibility to the
epigenetic form of this disease with onset after age 50, as well as the
genetic-based ``early'' onset form of the disease.
It is possible that the opportunities afforded by human pluripotent
stem cell research will lead to molecular markers or surrogate or
combinations of both that can be utilized for population-based studies
of gene-environment interaction in disease etiology. By using the
toxicity screening, by human pluripotent stem cell coupled with DNA
micro-array technology and gene expression profiling, it may be
possible, within a decade, to construct complex data matrices of gene
expression that constitute for each possibly toxic chemical a
``signature'' that could provide information by relating that chemical
to others of known toxicity. Human pluripotent stem cell research
offers great promise for use in testing the beneficial and toxic
effects of biologicals, chemicals and drugs. Such studies will lead to
fewer, less-costly, better-designed and more specific diagnostic
procedures as well as more effective systemic therapies, not to mention
the contribution of enhanced understanding to the development of
strategies for prevention of disease.
national aging institute
Human pluripotent embryonic stem (ES) cells hold enormous potential
for cell replacement or tissue repair therapy in many degenerative
diseases of aging. For disorders affecting the nervous system, such as
Alzheimer's and Parkinson's diseases, amyotrophic lateral sclerosis,
and spinal cord and brain injury, transplantation of neural cell types
derived from human ES cells offers the potential of replacing cells
lost in these conditions and of recovery of function. Human ES cells
could provide a model for studying fundamental molecular and cellular
processes important in the understanding of aging and age-related
diseases. However, before the full medical potential of ES cells can be
realized, much research needs to be done on the basic biology of human
ES cells.
Pluripotential and self-renewal capacity of human ES cells.--The
potential use of ES cells in human medicine hinges on the possibility
that ES cells can be grown in large numbers and that they can be
induced to form all human cell types. Factors controlling the self-
renewing ability of human ES cells must be explored and compared to
self-renewal properties of fetal and adult stem cells. Factors that
control the pluripotent nature of ES cells, that is, their ability to
form various cell types when grown in culture or when transplanted into
human tissue must be studied. The role of telomerase and other gene-
regulating proteins in self-renewal, cell fate determination, and
senescence could be examined.
ES cells for transplantation and tissue repair.--Human ES cells
could be used in tissue regeneration therapy in, for example, age-
related neurological, cardiovascular, musculoskeletal, and immune
system problems. Work in animal models of human nervous system
diseases, such as demyelinating disorders and spinal cord injury, has
provided evidence that mouse stem cells can survive, differentiate, and
give some degree of functional recovery following transplantation to
the affected region of the nervous system. The ability to use human ES
cells in research would allow validation of such a cell replacement and
repair strategy in animal models of human diseases. This could lead to
potential transplantation of human ES cells into the brains of
Alzheimer's and Parkinson's disease patients to replace lost or
dysfunctional cells in the affected brain regions. ES cells also could
be genetically modified to express certain proteins, such as neuronal
growth factors, and then transplanted into affected brain regions in
which locations they could provide local delivery of the critical
therapeutic factor(s). ES cells could be used to effect bone and
cartilage repair in osteoporosis and osteoarthritis, to reconstitute
the immune response in age-related or genetic disorders, and to promote
muscle regeneration in age-related progressive muscle wasting &
strength decline. The ability of human ES cells to generate an immune
response following transplantation could be assessed and compared to
fetal or adult stem cells to see if they could be used to reduce the
problem of rejection following cell therapy.
The ability to use human ES cells in research would allow intensive
studies to be performed to understand factors leading to optimum
therapeutic benefit, including determining the best type of cells
(embryonic, fetal, or adult stem cells) for transplantation and what
happens when cells are transplanted into hosts of different ages or
into hosts with different or multiple diseases. A better understanding
of the fundamental, biological properties of human ES cells could lead
to their successful use in cell transplantation and tissue regeneration
therapies in age-related disorders.
national institute of arthritis musculoskeletal and skin diseases
Generation of replacement cells and tissue to treat diseases
Because stem cells constitute a self-renewing population of cells,
they can be cultured to generate greater numbers of bone, cartilage,
muscle and skin cells than could be obtained from a tissue sample.
Equally important, if a self-renewing population of new stem cells can
be established in a transplant recipient, it could effect long-term
correction of many diseases and degenerative conditions in which bone,
cartilage, muscle and skin cells are deficient in numbers or defective
in function, such as in osteogenesis imperfecta and various
chondrodysplasias.
national institute on deafness and other communication disorders
Pluripotent stem cells research has tremendous potential for
developing therapeutic strategies for regenerating selected populations
of cells the degeneration or loss of which causes debilitating disease.
Several clear examples include degeneration of insulin-producing cells
in the pancreas which causes Type 1 diabetes mellitus, and degeneration
of a subset of neurons in the brain which results in Parkinson's
Disease.
By age 70, it is estimated that as many as one third of all
Americans have significant hearing impairment that compromises human
communication using spoken language. Many of these individuals also
have problems with balance, which leads to falls and limits their
mobility. The cause of this loss of hearing and balance is most often
degeneration or loss of hair cells, which are the specialized cells in
the inner ear that detect sound and provide sensory input needed for
balance.
national institute of mental health
Human embryonic stem cells are a critical resource for studies of
biological and disease processes, and for the creation of disease
models. Human stem cells provide a model to study the factors that
regulate differentiation, migration, and survival of neurons and glia
in the brain. Because developmental factors are implicated in the
pathophysiology of mental disorders (e.g., schizophrenia, autism, etc),
it is important to understand the factors regulating critical
developmental events that control stem cell fate in the central nervous
system. Stem cells hold tremendous promise for the discovery and
development of novel therapeutic targets such as growth factors and
other signaling molecules. Stem cells also represent the most promising
source of cells for use in transplantation therapy. Ultimately, stem
cell research may provide important insights into the pathophysiology
and treatment of mental disorders.
national institute on drug abuse
Stem cells can be a valuable resource to drug abuse researchers,
particularly those investigating the effects that drugs of abuse have
on development. Stem cells can be potentially used to replace cells
damaged by neurotoxic drugs. Using stem cells can also allow us to
better determine the more subtle effects of drugs on the developing
embryonic and fetal development tissue systems.
national institute on alcohol abuse and alcoholism
The value of pluripotent stem cell research would be in elucidating
mechanisms of cellular differentiation. With this knowledge, scientists
would have the potential to selectively differentiate cells into
various tissues.
Alcohol is a major source of damage to organs, such as the liver
and brain, that may or may not regain function with abstinence from
drinking. Development of medications that accelerate recovery in organs
damaged by alcohol would be a major breakthrough. Such an advance would
lessen human suffering and the economic burden associated with alcohol-
induced organ damage. For cases of irreversible organ damage, stem cell
research could be used to facilitate generation of new organ tissue.
The following examples demonstrate the potential utility of this type
of research to the alcohol field:
Reversal of cognitive deficits in alcoholics: Treatment of memory
problems as a result of long-term drinking can be problematic because
patients have difficulty remembering instructions from therapists.
Although in less severe cases recovery is possible after 3-5 years of
abstinence, initial treatment is less effective, and patients are more
likely to relapse. In the case of Korsakoff's syndrome, deficits can
require lifetime institutionalization of patients. Transplantation of
stem cells using appropriate growth factors may reverse the
neurochemical and behavioral deficits induced by chronic ethanol
administration. This approach might ultimately reduce the costs of
long-term care.
Organ transplantation: Alcoholic liver disease ranks second as the
cause of end-stage liver disease necessitating liver transplantation.
Given the scarcity of organs for transplantation, in vitro stimulation
of pluripotent stem cells into liver cells and other specialized cells
offers the extraordinary possibility of replacement cells and tissues
for treatment.
Fetal Alcohol Syndrome (FAS) cognitive deficits: Pluripotent stem
cells would provide investigators with a tool to study how alcohol
disrupts cellular differentiation at various stages of embryonic
development. Findings from this research would contribute to the design
of potential interventions for FAS.
national institute of nursing research
The NINR does not perform research involving embryos or stem cells.
However, nursing research will benefit from the technological advances
resulting from such research. When embryo or stem cell clinical
applications involve patient care, nursing research studies will
contribute to the science base for health care professionals,
especially nurses.
national center for research resources
1. Potential for stem cell cure of Type 1 Diabetes versus the
present insulin injection treatment.
2. Potential cures for Parkinson's and Alzheimer's Diseases through
embryonic stem cells.
national human genome research institute
The Division of Intramural Research at the National Human Genome
Research Institute is using the tools produced by the Human Genome
Project, supported by the Institute's extramural research program, to
study the fundamental mechanisms of development and the contributions
of genetic factors to disease. NHGRI investigators have identified the
following as potentially promising areas of study involving pluripotent
stem cells:
Gene Expression.--The differentiation potential of pluripotent stem
cells make them important candidates for studies of alterations in gene
expression profiles. Being able to examine the genes that are turned on
and off during the differentiation process of these cells, using newly
developed microarray technology, could supply very useful information
about normal and abnormal cell development. This information could have
promising application to a whole host of disease areas.
Parkinson's Disease (PD).--PD is caused by degeneration of neurons
in the region of the brain, the substantia nigra, leading to severe
abnormalities in movement. The cause is largely unknown, although in a
few rare families with early onset disease, mutations in the gene for
alpha synuclein are known to be responsible. As with other
neurodegenerative disorders, replacement of damaged nerve cells with
stem cells is one avenue of possible therapy. Current experiments using
fetal cells for replacement have provided very mixed results,
especially for the long term. One possible explanation for the less
than complete replacement is that the cells being transplanted are too
far along in path of development and differentiation to be able to take
up residence in the substantia nigra, make all the correct connections,
and replace the damaged cells. Using even less differentiated cells,
such as embryonic stem cells, is a possible alternative.
Gene Therapy.--Almost any genetic disease for which cell and tissue
transplantation protocols exist could potentially benefit from the
application of embryonic stem cells in gene therapy. For example,
patients with genetic disorders of the immune system might benefit
greatly from studies involving gene transfer using specially derived
pluripotent stem cells. Studies involving these cells also may be
useful in immune reconstitution or in engineering immunologic
resistance by HIV infected individuals.
Blood Disorders/Sickle Cell Disease.--The epsilon globin gene is
expressed only in embryonic red blood cells. This gene recently has
been shown to block the sickling of red blood cells by hemoglobin.
Research involving embryonic stem cells could help answer questions
about how to turn on the epsilon globin gene in adult blood cells and
thereby halt the disease process. Stem cell research may also help
produce transplantable cells that would not contain the sickle cell
mutation.
Senator Specter. Thank you very much, Senator Feinstein.
Coming back to the stem cell issue, because that is going
to be the subject of major floor debate on legislation which we
have introduced to eliminate the restriction on NIH doing
funding on embryos, there has been substantial resistence to
eliminating that restriction on the, I think, misguided ground
that we are dealing with potential human life, when in fact
these are discarded human embryos. It is going to be a real
battle, though. And I would like to explore it for a moment or
two.
I know Senator Harkin is going to go back to Dr. Spiegel
about the potential for juvenile diabetes.
But what substance is there to the argument that there are
alternatives, such as umbilical cords or other avenues of
approach to get adequate numbers of stem cells for research?
Who is the best person to answer that, Dr. Kirschstein?
Dr. Kirschstein. I think many of my colleagues could, maybe
Dr. Fischbach, Dr. Spiegel----
Senator Specter. Dr. Fischbach, we will start with you,
since my red light will be on momentarily, too.
Dr. Fischbach. I will be brief. There are many sources of
stem cells. And I am optimistic about stem cells from adult
animals, but I think stem cells from embryos will also be
extremely important. And I would be reluctant to rule out any
source.
The devastating illnesses that are going to be treated by
these stem cells demand that we explore every possibility.
Senator Specter. Well, Dr. Fischbach, beyond being
unwilling to eliminate any source, that really does not
directly answer the question as to whether there would be an
adequate supply of stem cells other than from human embryos.
What is it about the embryo which requires its availability
for stem cell research to get the maximum benefit, to----
Dr. Fischbach. At the present time, embryonic stem cells
can divide and grow outside the body for an unlimited period of
time. So by geometric multiplication, they can provide enormous
stores of cells that can be used medically.
It is a matter of research in the future to try and
transform stem cells from adults, because adult stem cells at
the present time do not have that capability of unlimited
growth and expansion for medical use.
Senator Specter. I would request that everyone submit to us
a written response as to the utility of eliminating that
funding limitation. We are going to have a knock-down, drag-out
floor battle in the Senate.
We put into our appropriations bill last year the
elimination of that prohibition in order to bring the matter to
a head. But we knew that we could not get the appropriation
bill through without a filibuster if that remained for floor
action. So we removed it with an agreement with the majority
leader to bring up a free-standing bill this year.
And I have talked to Senator Lott, and he is prepared to do
it shortly. But we will need all the evidence we can get as to
why that prohibition ought to be eliminated.
youth violence
Dr. Hyman, I am interested to know what progress has been
made on our allocation of almost $900 million to school
violence. We took that up, as you know, and you attended one of
three lengthy sessions where we brought people in from various
disciplines to try to treat school violence--as Dr. Koop said
in 1982 as surgeon general, that it is a national health
problem. And you have a very leading role in it.
Could you give the subcommittee an update as to what has
been done in furtherance of your work and, perhaps to the
extent you know, by the other people we met with where we had
that very substantial funding allocation?
Dr. Hyman. I will be brief, and I will give you a complete
answer for the record. But I will answer in two regards. First,
in regard to the research that has been initiated at NIH,
including NIMH, and then in some of the cooperation across
government agencies, which I think has actually been almost
unique in my experience, in terms of research at NIMH, we have
been focused on two areas.
One is interventions before somebody goes down the wrong
road. We have recognized that children with either mood
disorders or attention deficit hyperactivity disorders that are
not optimally treated are at much higher risk for subsequent
violent behavior and incarceration.
And we have completed several clinical trials and are
initiating new clinical trials in areas to help us understand
the best and safest ways to intervene early for these children.
For children who are already engaged in violent behavior,
we have also initiated research on optimal ways of diverting
them off this path.
And one--just to be very brief, one very important insight,
although it sounds almost like common sense, is that the final
common pathway for a lot of children into either violent or
criminal careers has to do with aggregation of antisocial peer
groups. And yet it is the practice in the United States to
literally create graduate schools for delinquency by having
group detentions, alternative schools, and incarcerating young
children often with hardened criminals.
There are interesting data and new clinical trials looking
at something called therapeutic foster care in which foster
parents are supported by professionals. And one of the
linchpins of this intervention is to make sure that these
youngsters do not associate with other antisocial peers. And we
have evaluations from some initial trials.
And, of course, I do not have answers for you yet, because,
based on new funding, we have just initiated some new
replication trials.
Just to give you a flavor of the cooperation, we have been
cooperating with SAMSA, especially the Center for Mental Health
Services, also with the Departments of Education and Justice.
We have had several meetings.
The Safe Schools/Healthy Schools Program has representation
from multiple agencies and I think has some really superb
demonstrations. It is too early to evaluate, but NIMH is
actually supporting sort of a research evaluation to make sure
that these collaborations actually do some good that we can
quantify and demonstrate.
Senator Specter. OK. Thank you, Dr. Hyman. We will look for
a more complete response in writing.
[The information follows:]
Youth Violence
Youth violence is a complex problem that requires complex
solutions. NIMH has long supported and conducted research to generate
information about risk factors, experiences, and processes that are
related to the occurrence, during childhood and adolescence, of
aggressive, antisocial, and violent behavior, and associated mental
health problems. Broad lessons drawn from this research underscore the
importance of a nurturing social environment in childhood, good early
education and success in academic areas; the prominent influence of
peers, whether positive or negative, on adolescent development; and the
potential risks of policies that endorse or require intervention
programs that house or otherwise group troubled adolescents. This
overview highlights what is known about risk factors for the
development of antisocial and problem behavior, and describes various
early prevention and intervention strategies.
Risk Factors.--Tragic events like the shootings at Columbine High
School are not typical of youth violence. Most adolescent homicides are
committed in inner cities and outside of school. They most frequently
involve an interpersonal dispute and a single victim. On average, six
or seven youths are murdered in this country each day. Most of these
are inner-city minority youths. Such acts of violence are tragic and
contribute to a climate of fear in schools and communities. Many
studies indicate that a single factor or a single defining situation
does not cause child and adolescent antisocial behavior. Rather,
multiple factors contribute to and shape antisocial behavior over the
course of development. Some factors relate to characteristics within
the child, but many others relate to factors within the social
environment (e.g., family, peers, school, neighborhood, and community
contexts) that enable, shape, and maintain aggression, antisocial
behavior, and related behavior problems.
NIMH-supported research on risk for aggressive, antisocial and
violent behavior encompasses multiple aspects and stages of life,
beginning with interactions in the family. Weak within-family bonding,
ineffective parenting (poor monitoring, ineffective, excessively harsh,
or inconsistent discipline, inadequate supervision), exposure to
violence in the home, and a climate that supports aggression and
violence put children at risk for being violent later in life. At
particular risk for violence are children who are exposed to the
contributors listed above and who have mental disorders such as
depression and anxiety and problem behaviors such as early conduct and
attention problems, and lower cognitive and verbal abilities. Outside
of the home, a major factor contributing to youth violence is peer
influence. In the early school years, a good deal of mild aggression
and violence is related to peer rejection and competition for status
and attention. More serious behavior problems and violence are
associated with smaller numbers of youths who are failing academically
and who band together, often with other youth rejected by prosocial
peers. Successful early adjustment at home increases the likelihood
that children will overcome such individual challenges and not engage
in behaviors that place them on a trajectory leading to violence.
However, exposure to violent or aggressive behavior within a family or
peer group may influence a child in that direction.
Longitudinal research has begun to identify broad categories of
young people who progress to adolescent antisocial behavior, the
multiple pathways through which such behavior develops and persists,
and the multiple factors that shape this risk. Two specific life course
trajectories, called life course persistent, which is viewed as a form
of psychopathology, and adolescence limited, which is identified only
in select social situations--offer a useful distinction both as a way
of thinking about developmental knowledge and as a tool for targeting
the right interventions for antisocial youth.
Life course persistent individuals begin antisocial behavior early
in childhood and continue into adulthood, after their adolescence
limited counterparts stop. Life course persistent behavior has been
correlated with neurological deficits and pathological behaviors,
(e.g., impulsivity) which are exacerbated when they are combined with
stressful home situations. In one study of 13 year olds, individual
differences--such as deficits in sensory, perceptual, and cognitive
abilities, including the use of language--were shown to predict
participation in crime five years later. One study found, for example,
that boys with poorer neuropsychological functioning, especially verbal
functioning at age 13, were more likely to have committed crimes at age
18 than were their counterparts with better neuropsychological
functioning at age 13.
Gender Differences.--From about 4 years of age on, boys are more
likely than girls to engage in both aggressive and nonaggressive
antisocial behavior. Much remains to be learned about the causes of
gender differences in antisocial behavior, but experts have suggested
that it might be necessary to define antisocial behavior somewhat
differently for boys and girls. Research has shown, for example, that
girls are more likely to demonstrate social aggression by damaging peer
relationships rather than by boys' overt aggression that inflicts harm
through physical damage or the threat of such damage. NIMH currently is
funding research on the antecedents and consequences of aggression for
girls and boys as an essential step toward developing empirically-based
interventions for aggressive children of both sexes.
Antisocial Behavior Co-Occurring with Child Psychopathology.--There
is strong evidence for the co-occurrence of two or more syndromes or
disorders among children with behavioral and emotional problems. An
obviously angry adolescent has other conditions such as anxiety
disorders and depression (as seen in the quiet withdrawn young person)
more often than would occur by chance. Research in this area indicates
that very young children with conduct problems and anxiety disorders or
depression display more serious aggression than youths with only
conduct problems. Although some available data suggest that conduct
problems often precede problems of depression, the sequencing of these
concerns is not entirely clear for youth. Whether depression
precipitates acting out, whether impairments and predispositions for
acting out lead to depression, or whether there are underlying causal
factors that are responsible for the joint display of such problems are
unresolved questions.
It is very common for youth with conduct problems to also display
symptoms of attention deficit hyperactivity disorder (ADHD), the most
commonly diagnosed behavioral disorder of childhood. The diagnosis is
made by the presence of persistent age-inappropriate inattention and
impulsivity, often coexisting with hyperactivity. This co-occurrence is
often associated with an early onset of aggression and impairment in
personal, interpersonal, and family functioning. Furthermore, academic
underachievement is common in youth with early onset conduct problems,
ADHD, and adolescents who display delinquent behavior.
Individual Liability and Genetic Factors.--Although understanding
of the nature of genetic influences on antisocial behavior is
incomplete, research on differences in the magnitude of genetic and
environmental influences on different kinds of conduct problems will
contribute to elucidating the developmental origins of antisocial
behavior. Twin and adoption studies indicate that child and adolescent
antisocial behavior is influenced by both genetic and environmental
factors, suggesting that genetic factors directly influence cognitive
and temperamental predispositions to antisocial behavior. These
predisposing child factors and socializing environments, in turn,
influence antisocial behavior. Research suggests that for some youth
with early onset behavior problems, genetic factors strongly influence
temperamental predisposition, particularly oppositional temperament,
which can affect experiences negatively. When antisocial behavior
emerges later in childhood or adolescence, it is suspected that genetic
factors contribute less, and such youths tend to engage in delinquent
behavior primarily because of peer influences and lapses in parenting.
The nature of the child's social environment regulates the degree to
which heritable early predisposition results in later antisocial
behavior. Highly adaptive parenting is likely to help children who may
have a predisposition to antisocial behavior. Success in school and
good verbal ability tend to protect against the development of
antisocial behavior, pointing to the importance of academic
achievement.
Parent and Family Factors.--Research has demonstrated that youths
who engage in high levels of antisocial behavior are much more likely
than other youths to have a biological parent who also engages in
antisocial behavior. This association is believed to reflect both the
genetic transmission of predisposing temperament and the maladaptive
parenting of antisocial parents. The importance of some aspects of
parenting varies at different ages. The impact of inadequate parental
supervision, for example, tends to be more pronounced in late childhood
and adolescence than in early childhood. Evidence from many studies
indicates that parental use of physical punishment may play a direct
role in the development of antisocial behavior in their children. Other
researchers have observed that parents often do not define antisocial
behavior as something that should be discouraged, including such acts
as youths bullying or hitting other children or engaging in ``minor''
delinquent acts such as shoplifting.
Research examining the mental health outcomes of child abuse and
neglect has demonstrated that childhood victimization places children
at increased risk for delinquency, adult criminality, and violent
criminal behavior. Findings from early research on trauma suggest that
traumatic stress can result in failure of systems essential to a
person's management of stress response, arousal, memory, and personal
identity that can affect functioning long after acute exposure to the
trauma has ended. One might expect that the consequences of trauma can
be even more profound and long lasting when they influence the
physiology, behavior, and mental life of a developing child or
adolescent.
Peer Influences.--Antisocial children with earlier ages of onset
tend to make friends with children similar to themselves. Consequently,
they reinforce one another's antisocial behavior. Children who display
age-inappropriate levels of impulsivity and hyperactivity (core
symptoms of ADHD) are often rejected and thus are more likely to
associate with other rejected and/or delinquent peers. The influence of
delinquent peers on later onset antisocial behavior appears to be quite
strong. Association with antisocial peers has been shown to be related
to the later emergence of new antisocial behavior during adolescence
among youths who had not exhibited behavior problems as children.
Socioeconomic Factors.--An inverse relationship of family income
and parental education with antisocial behavior has been found in many
population-based studies. Across gender and ethnicity, much of the
inverse relationship between family income and antisocial behavior is
accounted for by less parental monitoring at lower levels of
socioeconomic status.
Studying the impact of communities and neighborhoods on children,
researchers have examined three major features: (1) structural and
demographic features, (2) exposure to situations or events, and (3)
community-level processes and forms of social control.
In terms of structural and demographic features, research on the
extent to which neighborhoods are characterized by deteriorating
housing, overcrowding, greater population density, and greater numbers
of female-headed households consistently shows strong correlations with
neighborhood crime rates and violence.
By living in deteriorating neighborhoods with higher crime rates,
children and youth are more likely to be exposed to and witness
robberies, assaults, and murders. Experiencing their neighborhood as
dangerous, young people are at increased risk for becoming anxious,
depressed, defiant, and/or aggressive. Children who have seen or been
the victim of violence are more likely to join gangs and report
carrying weapons to school.
A newer line of research has begun to examine how community-level
processes and forms of social control may be important factors related
to youth delinquency. Studies which have examined the extent to which
members of the community share collective willingness to intervene in
youth misbehavior have shown these forms of collective social control
to correlate with decreased rates of delinquency and problem behaviors.
Prevention and Intervention.--NIMH-supported investigators have
developed and tested several effective programs and strategies to
prevent youth violence at different stages of childhood, including
programs for pre-school children, which are not discussed in this
report. In light of the Subcommittee's interest in inter-agency
collaborations, however, it is noteworthy that the Administration on
Children, Youth and Families (ACYF) and the NIMH have awarded several
research grants as the core component of a new young children's mental
health research initiative designed to develop and test applications of
theory-based research or state-of-the-art techniques for the
prevention, identification and/or treatment of children's mental health
disorders within a Head Start context. Among these are projects to
develop screening tools for identifying behavior problems in preschool
children, to test the effectiveness of research-based classroom
interventions for very young children with serious disruptive behavior
problems, and to assess the mental health needs of this vulnerable
population.
School-Age Children.--Research has found that between 70 and 80
percent of children with diagnosable mental disorders who receive
services are served within the school system, primarily by school
psychologists and guidance counselors. The NIMH has supported many
projects designed to develop, establish, and improve school-based
mental health service delivery systems. These projects range from broad
programs intended to enhance the social and problem solving skills of
all students, to highly specific programs designed to treat children
already showing symptoms of mental health problems. Programs also range
from those that intervene at multiple levels, including the child,
parents, peers, and teachers, to those that focus solely on the child.
For example, research is developing techniques for teachers to manage
disruptive students.
The Families and Schools Together (FAST) Track Program is a multi-
faceted, multi-year program designed for aggressive children in
kindergarten, starting at age 6. A four-site study in North Carolina,
Pennsylvania, Tennessee, and Washington, FAST Track involves working
with the child, the family in their home, and school system, including
teachers. Preschool children at high risk were identified at 55
different schools. These children were randomly assigned for
intervention or no intervention. The children initially enrolled in the
study are now young adolescents. An evaluation of FAST Track found that
by the third grade, students who took part in the program showed less
oppositional and aggressive behavior and were less likely to require
special education services than students who did not take part.
The Linking the Interests of Families and Teachers (LIFT) Program
is a 10-week intervention created for children and families who are at
risk for the development of conduct problems due to residence in
neighborhoods characterized by high rates of juvenile delinquency. The
LIFT Program is a multi-component intervention that includes parent
training, social skills training, a playground behavioral program, and
regular communication between teachers and parents. Following program
participation, students engaged in significantly fewer aggressive
behaviors on the playground, parents demonstrated fewer negative
behaviors during family problem-solving activities, and teachers
reported improved student social behavior and peer interactions. Three
years following the intervention, LIFT program students were less
likely than their non-LIFT counterparts to engage in consistent alcohol
use, to have troublesome friends, to have been arrested for the first
time, or to demonstrate inattentive, impulsive, overactive, and
disruptive behaviors in the classroom.
Research-based programs also have been initiated to enhance the
skills and knowledge of all children in order to decrease their risk of
future emotional and behavioral problems. NIMH has sponsored the
Promoting Alternative Thinking Strategies (PATHS) Curriculum, based in
Washington State, which teaches children about self-control,
understanding emotions, and problem solving. The PATHS curriculum has
been evaluated using students in both regular education and special
education classrooms. Students who received the PATHS curriculum
demonstrated better knowledge of emotions than children who did not
receive the curriculum. This emotional knowledge is thought to underlie
the development of necessary social skills such as friendship
development and maintenance, anger management, conflict resolution, and
appropriate problem solving.
The research highlighted above is, for the most part, sponsored by
NIMH. In addition, numerous components of the National Institutes of
Health (NIH) along with other Federal agencies have been active in
responding to the Subcommittee's expressed interest in research
concerned with developing and evaluating the effectiveness and
sustainability of programs aimed at prevention, early recognition, and
intervention for depression and youth suicide in school and community
settings.
On October 28 and 29, 1999, a meeting of investigators with
extensive and recognized expertise in youth violence research was held
at the National Institutes of Health Neuroscience Center in Bethesda.
This meeting was organized in response to a request from former NIH
Director Dr. Harold Varmus to convene a trans-NIH expert panel on youth
violence intervention research. It was co-sponsored by the Office of
Behavioral and Social Sciences Research (OBSSR), the NIMH, the National
Institute of Child Health and Human Development (NICHD), the National
Institute on Drug Abuse (NIDA), the National Institute of Nursing
Research (NINR), and the National Institute on Alcohol Abuse and
Alcoholism (NIAAA). The Expert Panel observed that much research has
been and continues to be devoted to identifying the multiple risk
factors that contribute to antisocial behavior as well as the
mechanisms by which they operate. The Panel noted that several, often
co-morbid, youth behavior problems (aggression and violence, high risk
sexual behavior, and drug abuse) share common risk factors in their
development. They pointed out that a number of these shared risk
factors reliably predict behavioral problems and can be successfully
changed through interventions. The Panel also observed that many other
factors have been identified as important in understanding risk for
behavior problems but have not been the target of focused
interventions. The meeting participants identified future research
needs that are informing research activities of the Institutes.
In January, 2000, NIMH joined the OBSSR and several other NIH/IC's
to co-sponsor a new RFA (OD 00-005) on developing and testing new
interventions to prevent and/or reduce youth violence. In excess of 150
letters signaling intent to respond to the April 14, 2000 application
due date have been received.
NIMH and the Center for Mental Health Services, Substance Abuse and
Mental Health Services Administration (CMHS, SAMHSA) are issuing a
joint program announcement (PA) to encourage research grant
applications on services delivered to children, adolescents and their
families through the CMHS's Comprehensive Community Mental Health
Services for Children and Their Families Program initiative. Conducting
the proposed research at one of the Children's Services Program sites
is a prerequisite for funding under this PA. This PA encourages studies
of the effectiveness of treatments or services delivered at these
sites, the nature and impact of routine clinical practice, and factors
related to successful implementation of treatments or services,
including interventions targeting violent behavior and related
problems.
On March 30, NIMH staff met with members of the Working Group on
Youth Violence Research, a component of the White House Council on
Youth Violence. Members of the Working Group include representatives
from the Departments of Health and Human Services, Justice, Labor,
Education, and other Federal entities. The Working Group is refining an
inventory of federal activities addressing youth violence; to make
information on violence prevention and other interventions available to
families, teachers, administrators and others involved in designing and
implementing programs; and to develop a coordinated federal research
agenda on youth violence.
Staff of NIMH and the Centers for Disease Control and Prevention
(CDC) are working closely to coordinate new CDC and NIMH efforts to
develop new interventions and to implement effective prevention and
treatment programs. This coordination has enabled NIMH and CDC to
cross-reference and link research announcements issued by each agency,
which already is enhancing the efficient use of federal research
resources in this area of science.
Finally, NIMH, CDC, and the Substance Abuse and Mental Health
Services Administration (SAMHSA) are collaborating in a major effort to
develop a Surgeon General's Report on the topic of youth violence. The
report, planned for release early in fiscal year 2001, will examine
advances in research regarding the occurrence and prevention of
violence and interventions for those who engage in violent behavior. In
order to raise public awareness about the critical issues surrounding
youth violence, the report will provide useful information to help
parents, schools and communities by identifying potentially effective
strategies for ameliorating the risk of violence among youth. In
addition, attention will be given to identifying approaches to
intervention that may be contributing to problems rather than reducing
them. This report will be an effective and highly credible means of
educating policy makers and the public about the interaction of mental
disorders and youth violence.
Senator Specter. Senator Harkin.
treatment for Juvenile Diabetes
Senator Harkin. Thank you, Mr. Chairman. I just want to get
back to Dr. Spiegel one more time on juvenile diabetes and stem
cells.
Again, enlighten me again on what role stem cells could
play in the further progress of what has happened at the
University of Alberta. And then give me some idea of maybe some
time frames that we are looking at.
Just from my reading, my non-scientific reading, of it, it
seems that this may be one of the earliest breakthroughs if, in
fact, the data that I see from Alberta is correct, in terms of
using stem cells to--and this is where my scientific expertise
lacks--using the stem cells to regenerate the kind of cells
that we need to replace the insulin-deficient cells in those
who are suffering from juvenile diabetes. I think I am within
the ballpark of scientific terminology there.
Dr. Spiegel. Let me try to be concise. To be clear, in the
Edmonton protocol, stem cells have not been used.
Senator Harkin. I understand that.
Dr. Spiegel. So they are using harvested inlets containing
insulin-secreting cells from donor pancreas.
Senator Harkin. Yes, sir.
Dr. Spiegel. What we are both enthusiastic and cautiously
optimistic about is that we hope this will be successful,
because if it is, it represents a long-sought cure for Type I
diabetes, juvenile diabetes.
But it will then create an enormous demand and need for
sources of insulin-secreting cells, which cannot possibly be
supplied at current donor rates. And that is why stem cells are
so absolutely critically important.
Because research into stem cells, both the pluripotent type
of embryonic stem cells that Dr. Fischbach alluded to, as well
as ones that are further along, such as stem cells from the
part of the embryo that would ultimately lead to both liver and
pancreas, understanding those developments are critical to be
able to provide a source for these kinds of transplantation
experiments.
And one final point: Basic stem cell research could also be
important in teaching us ways to intervene in individuals with
Type I diabetes to get regeneration of their existing stem
cells. And this is potentially an important modality of
treatment as well, which would be an alternative or complement
to transplantation.
Senator Harkin. I appreciate that, Dr. Spiegel. Could you--
I hate to ask for more paperwork. But with regard to this area
and the answer you just gave, if you could reduce that to
writing for me and just get that to me, I sure would appreciate
it.
Dr. Spiegel. I would be pleased to.
[The information follows:]
Stem Cell Research and Diabetes
Type 1 diabetes is a disease for which stem cell research holds
great promise. Research on islet cell transplantation and stem-cell
biology offers compelling opportunities for the development of new,
innovative approaches for treating and ultimately curing this disease.
Type 1 diabetes is characterized by the inability of the body to
produce insulin, a hormone necessary for glucose metabolism. It arises
when the body's immune system attacks and destroys its own insulin-
producing beta cells in the islets of the pancreas. The result of this
``autoimmune'' disease process is high levels of blood glucose, which
are difficult to control with insulin injections. Moreover, although
treatment with insulin sustains the patient's life, it does not prevent
the devastating complications of the disease. These include kidney
failure, blindness, amputation, heart attack and stroke. Clinical
trials have shown that these complications can be prevented or
significantly delayed by maintaining blood glucose levels as close to
normal as possible. However, achievement of such intense blood glucose
control requires multiple daily injections of insulin or use of an
insulin pump--an extremely difficult regimen to follow, especially for
children and teenagers, and one that always poses a risk of dangerously
low blood sugars.
To address these problems, researchers have pursued alternative
approaches to restoring insulin-producing capacity--including research
to develop an artificial pancreas, research on whole pancreas
transplantation, and studies of islet cell transplantation. Formidable
bioengineering problems attend development of an artificial pancreas,
and while researchers are working diligently to overcome them, a time
frame for success cannot be predicted. Whole pancreas transplantation,
while successful in some patients, is an extremely difficult surgery.
It requires lifelong treatment with immunosuppressive drugs that can
have toxic side effects. Moreover, whole pancreas transplantation does
not have as high a rate of graft survival as kidney transplantation.
This surgery is typically performed only in adults, often in
conjunction with a needed kidney transplant for which immunosuppressive
drugs would already be required.
Islet cell transplantation has several potential advantages. For
example, insulin production could be restored with islets alone, which
would be a much simpler procedure than pancreatic transplantation.
Ideally, islet cell transplantation could be achieved with one or two
infusions of cells on an outpatient basis without the need for chronic
immunosuppressive drugs. Until very recently, serious technical
problems have been a major impediment to rapid progress in islet
transplantation research. The two key challenges have been: (1) to keep
the body's immune defense system from rejecting the transplanted
islets, and/or causing recurrence of autoimmune destruction of islets,
and (2) to ensure that there is a sufficient supply of islet cells for
transplantation. To date, only about five percent of people with
diabetes who have received transplanted islets along with
immunosuppressive drugs have been able to stay off insulin longer than
one year. Recent scientific developments offer the potential to
overcome these obstacles and have propelled researchers to focus more
intense efforts on islet cell transplantation. This therapy is now
viewed as a highly promising means of curing type 1 diabetes,
especially for children and young adults whose disease has not yet
progressed to the point of debilitating complications.
The renewed promise of islet cell transplantation derives from two
complementary research opportunities that could overcome the challenges
that have stymied progress in this field. The first opportunity is the
development of new methods for modulating the immune system to both
preserve residual insulin-producing capacity and to keep the body from
rejecting transplanted islet cells. The second opportunity is the
prospect that stem cell research could ensure the needed supply of
islet cells for transplantation. Together, these opportunities offer
unprecedented hope for curing type 1 diabetes. They are also highly
consistent with major recommendations of the Strategic Plan of the
congressionally directed Diabetes Research Working Group.
The first new opportunity, the development of novel immune-
modulating methods, is the focus of multiple research initiatives
across the NIH, including NIDDK, NIAID and NCRR. Scientists are making
progress in finding ways to both halt the attack of the immune system
on its own tissue and to prevent the body's rejection of transplanted
organs and tissues--without the lifelong need for immunosuppression.
Following promising preliminary results in experimental animals,
clinical investigators are pursuing studies of novel biologic agents
that offer the prospect of modulating the immune system in such a
manner that transplanted organs and tissue are indefinitely accepted by
human recipients. Initial clinical studies applying immune modulation
therapy are being performed in patients receiving a kidney transplant
for end-stage renal disease. Later this year, researchers plan to
transplant insulin-producing pancreatic islet cells into patients with
selected forms of type 1 diabetes.
Of particular promise are studies currently under way by a team of
researchers at the Unversity of Alberta, Edmonton, Canada. These
researchers have developed and are following a revolutionary protocol
for islet cell transplantation in patients with type 1 diabetes. This
protocol involves treatment with an antibody to a cytokine receptor;
rapamyacin; and a low dose immunosuppressant. It is particularly
noteworthy that this protocol did not use glucocorticoid steroids as an
immunosuppressive agent. In addition to having well-known side effects,
such as growth retardation and increased risk of osteoporosis, these
steroids are also toxic to islets. The researchers expect to report on
their results in a scientific journal in the very near future. The
Juvenile Diabetes Foundation International (JDF) provided support for
the initial research in Edmonton. Now, plans are under development to
replicate this approach, with support from the NIAID, NIDDK and the
JDF, at several transplant centers that harvest their own islets.
To the extent that islet transplantation therapy proves successful,
there will be a great need for more islet cells. Currently, the NIH is
working to perfect methods to increase the yield of these cells from
pancreatic tissue; however, the ultimate solution will be to obtain
them from other sources, such as stem cells. In this regard, it is
vitally important to pursue simultaneous research on two fronts of stem
cell biology: embryonic stem cells and adult stem cells.
Embryonic stem cells offer the greatest promise of providing a
limitless source of islet cells for treating and curing type 1
diabetes. Embryonic stem cells are called ``pluripotent,'' because they
have the ability to develop into most of the specialized cells or
tissues in the human body. These stem cells can be derived from embryos
that were intended for in vitro fertilization, were not used, and are
donated for research purposes. Because embryonic stem cells mark the
earliest stages of human development, they have not yet differentiated
into specific types of organs and tissues. Thus, the possibility exists
that these cells could be made to differentiate into specialized tissue
needed for transplantation therapy, such as islet cells. Because
embryonic stem cells have the unique property of being capable of
limitless division and self-renewal, they can be maintained
indefinitely in tissue culture. Thus, their potential benefits for
research and medicine are enormous.
Another potential source of islet cells for transplantation are
stem cells found in the tissues of adults. Although these cells do not
have the same capabilities as embryonic stem cells, they could prove
useful in islet cell transplantation. Adult stem cells undergo
asymmetric division, with some becoming stem cells capable of
replenishing the tissue in which they are located, while others are
capable of specialization into different tissue. Thus, adult stem cells
are at an intermediate point in the differentiation process--beyond the
embryonic stage, but not irrevocably committed to a final cell or
tissue type. If researchers were able to identify and isolate
pancreatic stem cells from adult tissue, it might be possible to direct
these cells to differentiate into islet cells. This possibility could
come to fruition as more is learned about the genes regulating cellular
development and differentiation.
The ability to use embryonic and adult stem cells as a means of
providing islets for transplantation therapy in type 1 diabetes will be
critically dependent upon a fundamental understanding of the
developmental pathways that lead to the formation of pancreatic islets.
A workshop on ``Stem Cells and Pancreatic Development'' held at NIH
provided evidence of impressive progress in identifying a cascade of
genes responsible for differentiation of cells from precursors in the
embryonic foregut to pancreatic islet and specifically beta cells.
Scientists at this workshop also reported on progress in
identification, growth, and transplantation of hematopoietic, neural,
muscle, liver, and pancreatic stem cells. Major recommendations for
further research to permit application of stem cell technology to
treatment of type 1 diabetes included:
1. Identification of molecular `signatures' of stem cells and
progenitors in the endocrine pancreas. Identifying all the genes
expressed in the mouse and human pancreas throughout development is a
goal of a major new NIDDK initiative on the ``Functional Genomics of
the Endocrine Pancreas.'' It is conceivable that some of the genes may
regulate cellular differentiation and thus could be used to direct stem
cells down the specialization pathway to become islet cells;
2. Generation of monoclonal antibodies to proteins expressed on the
surface of islet beta cells and islet cell precursors to use in
identification and isolation of pancreatic stem cells.
3. Identification of growth conditions that permit the
proliferation and differentiation of lineage-specific stem cells both
inside and outside the body;
4. Exploration of the potential use of embryonic stem cells, and
tissue-specific stem cells, in the formation of pancreatic islets; and
5. Use of animal models to examine the role of stem cells in the
regeneration of the endocrine pancreas.
Applying basic knowledge obtained from research in developmental
and stem cell biology will enable the production of progenitor stem
cells and the rational design of cellular therapies for human diseases
such as diabetes. It is essential to underscore that studies of stem
cells and the genes that regulate their development could be important
as ways to intervene in type 1 diabetes, even beyond their use in islet
cell transplantation. For example, a more precise understanding of stem
cell biology could lead to methods to activate stem cells and to
regenerate beta cells of the pancreas. Coupling immune modulation
treatment to halt further autoimmune destruction of the islets with
treatments to activate stem cells to regenerate beta cells would offer
a powerful approach to prevention and treatment of patients at risk for
development of type 1 diabetes.
Thus, researchers have attained a very encouraging benchmark with
respect to developing new clinical approaches to type 1 diabetes. They
are currently pursuing a two-pronged approach involving both immune
tolerance and stem cell biology to overcome previous impediments to
successful islet cell transplantation. Inducing immune tolerance can
halt or reduce the autoimmune attack on the insulin-producing cells of
patients and help them retain some insulin reserve. In essence, this
approach provides a ``shield'' to block the autoimmune attack and
protect the residual insulin-producing cells from further destruction.
The second prong of therapy is islet transplantation-based on novel
methods of immunomodulation to prevent graft rejection, coupled with
research on stem cell biology to provide a limitless source of islets
for transplantation.
Human Genome Project
Senator Harkin. Dr. Collins, on the human genome project,
could you again enlighten me, and perhaps the press who is here
and the public, there has been this big debate about Celera and
you and this race to the finish and their patenting the gene
and all that.
A lot of people have asked me, well, wait, if you, the
human genome project, is mapping and sequencing the human gene,
and it is going to be here in another 1\1/2\ years or 2----
Dr. Collins. We expect to have the finished sequence in
2003, but a working draft will be done in the next 2 or 3
months.
Senator Harkin. OK. So 2003. And that is going to be
available to the public?
Dr. Collins. Yes.
Senator Harkin. All the knowledge, everything, all the
mapping, all the sequencing you have done on the human genome.
Dr. Collins. Every 24 hours.
Senator Harkin. All day long. So if a private company has
already done that, and they have tried--why would a researcher
then feel it necessary to go to a private company to get that
kind of information, when they can go to NIH and get that
information? So why do I care if Celera does whatever they are
doing? As long as it is done in NIH, why should I care? I mean,
it would be available to researchers all over. What is the
problem?
Dr. Collins. Well, Senator, I appreciate the question, and
I appreciate this subcommittee's support of the Human Genome
Project over the last 10 years. You had the vision of this
project even before some of the rest of the scientific
community had caught on. That vision is clearly paying off.
We are at a very exhilarating time. Just yesterday we
announced that we have crossed the 2 billion base pair mark.
Senator Harkin. Wait a minute. I was just at the 1 billion
base----
Dr. Collins. Well, there you go.
That is right. We appreciated your attending the ceremony
in November to celebrate 1 billion. And yesterday we got to 2
billion. It was T, by the way. The second billion bases were
capped off by a T.
And since the genome is only 3 billion, you can see that
this working draft is coming along very quickly. It will
require the course over the next 2 or 3 years to close the gaps
and deal with the ambiguities that still remain in this draft
version. But for many scientific applications, this will be
enormously useful. And it is useful to anybody with an Internet
connection.
I think the parallel that I might try to draw for you is
one that is perhaps familiar to people within these halls, and
that is the Thomas System for keeping track of what is going on
with regards to congressional legislation and other hearing
transcripts and so on.
There is this system, which citizens can go to if they are
seeking information about what is happening in the U.S.
Congress. And it is available for free to anybody who needs to
find it out.
There are other more elaborate systems, of course, that you
can pay to subscribe to, such as Lexus Nexus or Congressional
Quarterly Search Service, which for the sophisticated user who
has the wherewithal to pay for them, are also useful.
We think of ourselves as the Thomas System for the human
genome project, where the basic information, the raw
fundamental sequence of the genome, and some basic information
about what it means, which our colleagues at the National
Library of Medicine are putting together, is available to
anybody in any country, whether in the private sector, the
public sector, wherever. As long as they have an Internet
contact, they can find out what we know right now, as of today.
But there will undoubtedly be uses of the genome sequence
that require a sophisticated level of annotation, of melding
together a lot of additional information in order to try to add
value to that basic information. We see that as a golden
opportunity for the private sector to set up, hopefully not
one, but many different competing databases that interested
subscribers can check out and decide if they think those are
worth their while to pay for.
I think that is the solution to what has been a sort of
tumultuous enterprise here, that we have the Thomas System, but
then we have these other available, highly annotated versions
that people who want to use them can subscribe to, if they find
that that meets their needs.
Senator Specter. Let me come back to you, Senator Harkin.
Senator Feinstein had some more questions.
Senator Feinstein.
AIDS Vaccine Development
Senator Feinstein. Thank very much, Mr. Chairman.
I would like to ask a question, if I might, about AIDS. The
President's budget includes a 12-percent increase in 2001 for
AIDS vaccine research. I was wondering if you could describe
NIH's plan for developing the vaccine and, given this increase,
if you could possibly be specific as to when a vaccine might be
available.
Dr. Kirschstein. Senator Feinstein, I am going to ask Dr.
Nathanson, the Director of the Office of AIDS Research, and Dr.
Fauci, the Director of the National Institute of Allergy and
Infectious Diseases, to share their response to that question.
Senator Feinstein. Thank you very much.
Dr. Nathanson. Yes. So let us talk first about the way we
are going about developing a vaccine, which I think was your
first question. And the second was when we would expect to
reach that goal.
We have a series of sequential approaches which start off
with some basic laboratory work on the virus, its proteins and
its genes, and then move into animal experiments. And we are
particularly using a rhesus monkey model of AIDS with a simian
virus, simian immunodeficiency virus, very similar to human.
And that can be rapidly used to improve the speed of this
translation, to test concepts much more quickly than we can do
in humans.
And then we move into a further translational effort where
we start first with phase one trials, which are safety trials
on a small scale in humans, and then phase two, immunogenicity
trials and extended safety trials, and phase three, efficacy
trials.
And we are expanding at all levels and basically pursuing a
number of concepts about how to make an effective and safe
vaccine in parallel because of the urgent need.
We have made considerable progress with some of those
concepts in animals. And at the present point in humans, there
is a phase two trial that is an immunogenicity trial of a
potential vaccine. It involves what is called a prime to start
the immune response and a boost of an additional protein. And
the results of that phase two trial will determine whether that
is going to be advanced to a phase three trial.
And I think Dr. Fauci might like to comment about that and
maybe add something to my comments.
Senator Feinstein. As to when we might----
Dr. Nathanson. Well, as to when we will get to the
potential phase three trial, this particular product could
start within about a year, if we decide to move forward. It is
a product the efficacy of which is somewhat marginal. And
therefore, there is some debate within the scientific
community.
In fact, my council happens to be meeting today. And last
night we did debate that somewhat. There are different views.
And I think Dr. Fauci might like to enlarge on that.
Dr. Fauci. The question really is twofold. When will we
engage in a trial that will ask the question if a vaccine is
effective? And then a much broader question that is much more
difficult to answer is: When will we have an effective vaccine?
Because one of the things we need to appreciate is,
particularly with HIV, in contradistinction to other vaccine
studies for other microbes, it is highly unlikely that the
first vaccine trial that we do will be a home run, where we
will have a highly effective vaccine.
The situation is a little bit different with HIV/AIDS. When
we deal with most of the vaccines that we deal with, namely for
childhood diseases, we will not accept anything less than a 90
or so percent effectiveness, because we want to make sure that
virtually each and every one of the children that we vaccinate
will be free of getting infected with the organism in question.
With HIV/AIDS, we will probably have step-wise gradation of
relatively more effective vaccines where the first one that is
available might be in a range of effectiveness that would be
unacceptable, for example, if it were a polio vaccine or a
rubella vaccine. And those kinds of successes would probably go
a long way to interrupting the kinetics of the epidemic,
particularly in developing countries.
For example, if you have a 35- to 45-percent efficacy of
vaccine that would be unacceptable for a vaccine that we would
use for a childhood disease, whereas that might, if given to
populations with a very accelerated rate of infection, might
interrupt the kinetics of the epidemic to the point that we
would have a major positive impact.
So it is really a complicated question and a complicated
answer. We will probably within the next year or so be going
into larger trials to ask a question, ``Is this at least
partially effective?''
But as Dr. Nathanson mentioned, while we are doing that, we
will be building up a pipeline of candidates that might in 4,
5, 6, or 7 years from now be much better than the candidates
that we are dealing with now.
Senator Feinstein. Thank you.
Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Feinstein.
Senator Kohl.
Senator Kohl. Thank you, Senator Specter.
Epilepsy research
Dr. Fischbach, I am pleased that today NINDS is sponsoring
a conference on epilepsy. I am hopeful that the discussions at
the conference will lead to a clearer strategy for research
into this disease. With that goal in mind, I have two
questions.
Report language last year discussed curing epilepsy, not
just finding new treatments for it. What is NINDS doing
differently to change its focus from finding new treatments to
finding a cure to stop epilepsy?
Dr. Fischbach. Thank you, Mr. Kohl. There is a wonderful
conference which is beginning this morning and continuing for 2
days, titled ``Curing Epilepsy,'' because the problem is that
all of the drugs currently on the market merely reduce
symptoms. More than a third of the patients in this country
remain burdened with seizures at one time or another. There is
no single therapy that completely eliminates them.
We have expanded our ADD Program, our Anti-epilepsy Drug
Development Program, looking for new medications with novel
targets, new ways that drugs may interfere with the epileptic
process that have not been explored before.
We have developed methods for new modalities of therapies,
such as brain stimulation, by stimulating outside the brain and
even with electrodes placed inside of the brain, in an attempt
to disrupt and cure epilepsy, defined as complete freedom from
seizures and complete absence of side effects. So those are
just two of the ways that we have approached it.
A third and extremely promising strategy is to make use of
resources now emerging from the genomic efforts to understand
the mutant genes underlying more than 50 percent of the cases
of epilepsy, which should lead to new and better diagnostic and
therapeutic approaches.
Senator Kohl. What is NINDS's strategy for focusing on the
population with intractable epilepsy?
Dr. Fischbach. This is the most difficult of all. And I
simply would say that the three approaches I just mentioned--
new targets for medicines, electrical stimulation to manipulate
circuits in the brain, and more molecular genetic approaches
will be beneficial to those patients. That is our hope.
Alzheimer's research
Senator Kohl. Thank you.
Dr. Hodes, it is my understanding that some research has
shown that Alzheimer's disease begins to destroy the brain
cells of its victims 10 to 20 years before outward symptoms
appear. Do we currently have the tools to diagnose Alzheimer's
disease in its earliest stages? And if not, what research is
being done to develop that capability?
Dr. Hodes. Senator, you are correct in that a number of
studies have shown that a combination of parameters, including
imaging, have been able to identify individuals who are at high
risk of developing Alzheimer's disease a decade or two later.
More recent studies, including some to be published this
week, have taken a step further in refining these imaging
techniques in particular, and have been extremely good at
predicting which individuals are likely, over the course of a
3- to 5-year follow-up, to develop Alzheimer's disease.
This has not yet reached the stage of practicality as an
intervention per se, but has an enormous impact in terms of
identifying individuals at high risk. The importance of
identifying individuals of high risk is particularly tied to
current studies to test an intervention designed to prevent
progression of disease.
So by identifying a population likely, if no intervention
is used, to develop Alzheimer's, we have an opportunity to
carry out the critical studies now beginning, to see if we can
interfere with that process.
Juvenile Diabetes
Senator Kohl. Thank you. Last summer, 9-year-old Lenisha
Patterson of Germantown, WI, testified before this subcommittee
on what it is like to live with juvenile diabetes.
I also have a short statement, which I would submit for the
record and a statement from 14-year-old, Rachel Malz of
Wisconsin, describing how diabetes has affected every day of
her life. Both of these children have asked the subcommittee to
promise to remember them and all the children who live with
juvenile diabetes. I am one of 55 Senators who are trying to do
just that.
[The statements follow:]
Prepared Statement of Senator Herb Kohl
Thank you, Mr. Chairman. And I'd like to welcome you, Dr.
Kirschstein, and all of your colleagues who have agreed to appear
before the Subcommittee today.
As we all know, over the past several years, Congress has provided
unprecendented funding increases for the NIH. I commend Chairman
Specter and Senator Harkin for their leadership in ensuring that NIH
has the resources it needs to achieve one of our nation's most
important goals: curing disease and alleviating human suffering.
It is both our hope and also our expectation, that this strong
investment will result in new treatments and cures for diseases. Not
only will this improve the quality of life of all Americans, it will
reduce the need for expensive treatments in the future by keeping our
nation's health care costs down.
I strongly support biomedical research and agree that Congress
should continue to provide the funds necessary to make this a reality.
However, in addition to providing the dollars, Congress also has the
responsibility to ensure that these funds are spent wisely. We have
provided these increases as part of a balanced budget--but we must not
forget that we have accomplished this by making some tough choices
between other health and education programs. It is critical that these
trade-offs can be justified by ensuring that research targets our
nation's most pressing health needs.
Again, I thank you, Mr. Chairman, for your support of NIH. I look
forward to the question period, when we will have a chance to explore
these priorities and results in more detail.
______
Prepared Statement of Rachel Malz, Madison, WI
Good morning. My name is Rachel Malz and I am from Madison, WI. I
am fourteen years old and I was diagnosed with Juvenile Diabetes when I
was only 21 months old. I do not remember even one day when diabetes
was not a part of my life. My diabetes has been very difficult to
control. I was placed on an insulin pump when I was ten to help control
all the ups and downs. However, at the age of twelve, my kidney tests
showed some problems, so my doctor started me on an Ace--Inhibitor
medication. Studies have shown these drugs may help keep my kidneys
working. As you can see, I am doing all I can to stay as healthy as
possible until a cure is found. I need all of you in that room today to
do your part and work together so it will happen soon. Thanks to you
and to Senator Kohl for the opportunity to share my story.
Senator Kohl. Earlier this year we sent a letter asking you
to fund more research into this area. I was pleased to learn
that NIH is planning to implement the scientific
recommendations of the Diabetes Research Working Group.
However, it is my understanding that doing so would cost
$827 million in fiscal year 2000, while NIH projects to spend
only $525 million.
I would appreciate knowing from you how NIH will be able to
implement these recommendations, given the fact that the
resources are presently lacking.
Dr. Kirschstein. NIH strongly endorses the scientific
recommendations of the Diabetes Research Working Group. And Dr.
Spiegel and I have had many conversations about this.
Within the constraints of the President's proposal for
fiscal year 2001, which was a 5.6-percent increase overall, we
provided to the Diabetes Institute a 5.9-percent increase. We
will work hard with the funds that are available and funds that
are given to us, to do the best and most important research
possible.
I think you heard from Dr. Spiegel how he is deeply
involved in some of the studies on juvenile diabetes. He and I
both understand the problems of that disease and feel deeply
for those children. And I would like to ask him to expand on
the discussion.
Senator Kohl. Thank you.
Dr. Spiegel. Thank you, Dr. Kirschstein.
And, Senator Kohl, I appreciate the opportunity. It brings
me back to the chairman's question. The Diabetes Research
Working Group suggests that NIDDK, for example, in 2001 should
increase its spending by $387 million. And within the budget
constraints of the President's budget, we expect to increase
from $313 million to $338 million. So you see that that falls
very substantially short.
Nonetheless, it is clear that there are some extraordinary
opportunities, specifically in genetics, genomics and in
clinical trials for Type I, Type II diabetes and obesity, all
significant problems.
So we are going to do the best that we can within the
constraints of the budget, but it is clear that there are
extraordinary opportunities which we would seize upon, if there
were additional resources.
Senator Kohl. Thank you, Mr. Chairman.
Senator Specter. Thank you very much, Senator Kohl.
NCI'S Budget
Let us try a round to see how this works on the questions
that I have posed. We will start with you, Dr. Klausner. You
and I have talked about this on a number of occasions. Question
one: What is the total funding for your institute?
Dr. Klausner. The proposed total funding----
Senator Specter. No. What is the current total funding for
your institute?
Dr. Klausner. $3.32 billion.
Senator Specter. And what percent of grants do you award?
Dr. Klausner. The success rate for grants will be 30 to 31
percent this year.
Senator Specter. And what is the total number of
applications you have?
Dr. Klausner. The total number of applications we have had
this year is a little less than 4,000.
Senator Specter. And what percentage would you like to
grant, or do you think are meritorious?
Dr. Klausner. I think what we would shoot for is about 40
percent.
Senator Specter. And what would the total funding be
necessary to make the grants that you would like to make?
Dr. Klausner. In order to achieve that level of funding
and--and I think this is important--at the same----
Senator Specter. You do not have to repeat the question. We
would just like the answer, because I would like to go around
the room.
Dr. Klausner. OK. We would require about a 20-percent
funding increase for the Institute to achieve the above success
rate.
Senator Specter. OK. Would you see if you could sharpen
that up a little for me on all those questions?
Dr. Klausner. Yes.
Senator Specter. I know we are catching you sort of off
guard here.
NHLBI's Budget
Dr. Lenfant, Heart, Lung and Blood Institute, what is your
total funding?
Dr. Lenfant. It is--including the AIDS component $2.025
billion.
Senator Specter. And how many grants have you made, are you
making?
Dr. Lenfant. In this year, it will be 1,050.
Senator Specter. And what percentage is that of the
applications?
Dr. Lenfant. It is 27 percent.
Senator Specter. And what percent grants would you like to
make, if you had adequate funding?
Dr. Lenfant. I will be consistent, and I will say 35
percent is really what we should support.
Senator Specter. And what kind of budget would you need to
do that?
Dr. Lenfant. That would require an increase of
approximately 16 percent.
NIDCR'S Budget
Senator Specter. Dr. Slavkin, dental, what is your total
funding?
Dr. Slavkin. Our current funding for fiscal year 2000 is
$269 million, including the AIDS budget.
Senator Specter. And how many grants have you made?
Dr. Slavkin. We project making 157 competing awards this
year. In the year that closed, our total was 131. And we
anticipate next year it will be 127.
Senator Specter. And what percent of the applications will
you be making grants to at the higher figure?
Dr. Slavkin. We will struggle to meet a success rate of 19
percent for fiscal year 2001. And so our----
Senator Specter. And what percent would you like to make?
Dr. Slavkin. Well, we have been hoping to reach at least a
33-percent success rate.
Senator Specter. And what total funding would that require?
Dr. Slavkin. For us, that would require an additional $41
million in funds for the competing research project grant line.
NIND'S Budget
Senator Specter. Dr. Fischbach, what is your total funding?
Dr. Fischbach. $1.03 billion.
Senator Specter. And how many grants have you awarded?
Dr. Fischbach. 2,000.
Senator Specter. And what percentage is that to the number
of applications?
Dr. Fischbach. It is 35. We are close to 35 percent.
Senator Specter. And what percent would you like to award?
Dr. Fischbach. 40 percent.
Senator Specter. And how much more money would that take?
Dr. Fischbach. That would require approximately a 20-
percent increase above the $1.03 billion.
possible Accomplishments
Senator Specter. What do you think you could accomplish
with that extra money, Dr. Fischbach?
Dr. Fischbach. I think we would do a significant amount
more in neuro-degenerative disorders--ALS, Huntington's
disease, Parkinson's disease, and Alzheimer's disease
especially. We would fund more consortial arrangements for
sharing of resources.
Senator Specter. We heard that as to Parkinson's, the
answer may be as close as 5 to 7 years. Would you confirm that?
Dr. Fischbach. That is the hope, and I am optimistic about
that.
Senator Specter. How about Alzheimer's?
Dr. Fischbach. That is an also extremely promising area of
research, as I am sure Dr. Hodes would expand on. But with new
discoveries about enzymes responsible for amyloid deposition,
there is renewed hope for new therapeutic targets.
Senator Specter. Could you give us a projection on time, if
you got the extra money?
Dr. Fischbach. On Alzheimer's disease, I think it is
difficult to project that. That is such a complex disorder
involving so many different systems within the brain that I
would hope that even prolonging useful cognitive life by 1 or 2
years in the next 10 would be an extreme advance.
Senator Specter. Well, would you all write down the
questions and provide--I am going to observe the time signals--
the total funding each of your units gets, the number of grants
you are able to award with that amount of funding, what percent
the awards are from the total number of applications, what
percent you would like to award, and what that would cost?
[The information follows:]
Institute/Centers Budgets
The following table summarizes the total funding levels requested
for each institute and center (IC) in the fiscal year 2001 President's
Budget request. It also provides the number of new and competing
research project grants (RPG) that each IC funds and the success rate
or percent of RPG applications each IC could fund within the fiscal
year 2001 President's Budget request.
The table also summarizes the success rates by IC associated with
funding all new and competing RPGs in fiscal year 2001 at the
professional judgment (PJ) level, as well as total costs associated
with funding at the PJ level. Professional judgment budgets, which
reflect each IC's best judgment of scientific opportunities available,
are formulated by each IC without consideration of competing pressures
or budgetary constraints or Administration priorities. NIH believes
that each IC's PJ budget represents the IC's judgment of scientifically
meritorious research.
As I have noted, the RPG success rate varies among ICs. This
variation reflects the difficulty of predicting total numbers of
applications as well as the importance of many other mechanisms in
funding each IC's best judgment of scientific opportunities available
for support in fiscal year 2001.
NATIONAL INSTITUTES OF HEALTH ADDITIONAL COSTS TO FUND PROFESSIONAL JUDGMENT BUDGET
[Dollars in millions]
----------------------------------------------------------------------------------------------------------------
Fiscal year 2001
--------------------------------------------------------------------
President's budget Funding professional judgement
--------------------------------------------------------------------
Additional Additional
Number of Success Success amount amount for
Total competing rates rates competing IC total
RPGs (percent) (percent) RPGs PJ budgets
----------------------------------------------------------------------------------------------------------------
NCI........................................ $3,505.1 1,271 30 42 $154.5 $629.9
NHLBI...................................... 2,136.8 811 29 43 146.9 193.6
NIDCR...................................... 284.2 127 19 33 40.9 74.0
NIDDK...................................... 1,209.2 715 34 50 107.0 160.5
NINDS...................................... 1,084.8 487 25 39 115.3 151.2
NIAID...................................... 1,906.2 831 31 39 110.4 159.9
NIGMS...................................... 1,428.2 882 26 33 81.3 128.8
NICHD...................................... 904.7 332 20 35 110.3 160.1
NEI........................................ 474.0 237 34 45 41.6 69.2
NIEHS...................................... 468.6 181 23 27 12.2 59.4
NIA........................................ 725.9 315 17 33 116.5 155.0
NIAMS...................................... 368.7 216 24 35 33.4 46.1
NIDCD...................................... 278.0 140 21 37 30.3 47.3
NIMH....................................... 1031.3 485 23 33 67.0 138.3
NIDA....................................... 725.5 262 21 32 46.9 113.4
NIAAA...................................... 308.7 123 23 48 43.1 102.6
NINR....................................... 92.5 50 14 26 12.1 17.5
NHGRI...................................... 357.7 43 32 42 11.2 72.5
NCRR....................................... 714.2 57 13 22 10.0 319.3
NCCAM...................................... 72.4 18 26 40 27.6 40.2
FIC........................................ 48.0 58 27 47 6.1 22.0
--------------------------------------------------------------------
Total................................ 18,124.7 7,641 26 38 1,324.7 2,861.0
----------------------------------------------------------------------------------------------------------------
Notes.--Because the question specifically focuses on RPGs and success rates, this table does not include
information on the National Library of Medicine, the Office of the Director, and Buildings and Facilities
activities.
May not add due to rounding.
Senator Specter. I am glad that Senator Stevens, the
chairman of the full committee has--Senator, if I may have
Senator Stevens' attention.
He came in just at the point where we were inquiring of
this distinguished group of scientists what funding they would
like to make awards on the meritorious grants. And that is a
good place for the chairman of the full committee to come in.
We do not have the answers, but I will provide them to you,
Senator Stevens. And I will also give you the floor at this
time.
OPENING STATEMENT OF SENATOR TED STEVENS
Senator Stevens. Well, thank you very much. And I am sorry
to just barge in. We have a whole series of subcommittees
meeting today, and I do like to stop in on each one and thank
the people involved for their participation.
I do think that we have a very tight budget this year. But
I also think--and I have been making speeches throughout the
country on the conclusion I have reached, really.
And that is that this group, NIH, represents an investment
in the future that, from a strictly conservative point of view,
we ought to increase the investment now to assure that you
are--that we are capable of dealing with the vast problems that
will come to our country when the baby-boomer generation
retires.
If we have the same degree of diseases in their generation
as exist in my generation, there is going to be a skyrocketing
cost that the budget just cannot absorb.
Though we are on the verge of so many breakthroughs, I
think the number one and most important investment we can make
this year--and I am chairman of the Defense Subcommittee--is
not in defense, but is in accelerating the research and
bringing about the developments and perfecting the application
of some of the breakthroughs we already have.
And I am--once again, Mr. Chairman, I am still ready to do
battle. We are going to continue to be on the course that we
are on, and that is: We are going to try to continue our
process that will, within 5 years, double the amount of money
that is available for research in NIH.
Now, that is the commitment you made and, I think, we all
made when we voted on that resolution. I take this resolution
very seriously.
Having said that, though, I do think that we have to find
some way to really make certain that this money is really going
to research and not necessarily to bricks and mortar. I am a
little slow about the bricks and mortar side of the budget.
I think the most important thing we can do now is
accelerate this research and put it in the hands of our most
competent people, and make sure that we get, to the maximum
extent possible, the breakthroughs we need so we can reduce
those future costs. That is the investment that I think we
should make.
And I thank you, Mr. Chairman.
Senator Specter. See how good Senator Stevens' timing is?
He came in at just the right moment. That is a pretty good
commitment from the chairman.
Senator Stevens. Thank you.
Senator Specter. Thank you for that, Senator Stevens.
Senator Harkin.
Gene Sequencing
Senator Harkin. That is a good commitment. I appreciate
that, Mr. Chairman.
Dr. Collins, I just want to wrap up this issue on the
genome. I read the statement put out by Prime Minister Blair
and President Clinton, statements made at the following press
conference by you and Dr. Lane.
I just want to make it clear. Since I have been involved in
this from the beginning, I just want to make it clear again
where I think we ought to be headed in this. And I want to make
it clear to the press that is here, too.
That raw fundamental data on the sequencing of the human
gene or any parts thereof should never be patentable. If a
private sector company wants to get patents, I believe that
company should take that raw available data, conduct
experiments like they would for any other drug, and if
experiments prove that it has application that a certain piece
of gene would produce a disease-related protein, for example,
and they can prove that through experimentation, and valid
experimentations, then I have no problem with a patent at that
point.
But it is my belief that we have put a lot of public money
into this globally, and that this raw data ought to be
available to any researcher anywhere free of charge.
And if companies want to seek to try to influence the
Patent Office, well, we have something to say about that here
legislatively, too. The Patent Office is a creature of the U.S.
Congress. I know that they have had their comment period closed
on March 22. And I am hopeful that they will be issuing
guidelines along that pathway.
But I have been quite upset, quite frankly, at some of the
private companies who have indicated by filing thousands of
patent requests, thousands of them, and they have not conducted
one experiment, and they have tried to get a patent on those. I
think that is not in the public interest. And I believe that--I
do not think that those patents ought to be issued.
So I just wanted to state for the record where I hope this
is headed. If you have any further comments, I would welcome
it. If not, you do not have to make a comment.
Dr. Collins. Senator, I think you have expressed the issue
very clearly. NIH has taken a position on the patenting issue,
which is quite close to yours, namely that sequence information
in the absence of any functional data about what that
particular gene does ought not to be the subject of----
Senator Harkin. Functional data means data based upon
adequate experimentation.
Dr. Collins. That is right. Whereas a circumstance where
such data does exist and is compelling, that puts this sort of
a gene patent application in the same category as other types
of patent applications and ought to be seriously considered.
Methamphetamine
Senator Harkin. I appreciate that. I said I had a couple of
other questions here, but I may have to ask for those in
writing. One had to do with methamphetamine because of the big
problem in the Midwest. Methamphetamine, not only can we cut
the supply, but the demand is a problem. And we find that this
is a very addictive drug.
I just wanted to ask Mr. Millstein what the Institute is
doing on research on meth and possible treatment options. I
have looked at this quite a bit, and it just seems like we are
not getting very far. But maybe you have some knowledge that I
do not know about.
Mr. Millstein. Thank you, Senator Harkin. As you are well
aware because you personally were involved in the town meeting
that NIDA sponsored in 1998 in Des Moines----
Senator Harkin. Right.
Mr. Millstein [continuing]. We used that as the kickoff for
the methamphetamine initiative. Our community epidemiology work
group, which is an early alert system, had shown tremendous
increases in use in rural areas, including Iowa.
We had that kickoff specifically in Des Moines with your
involvement, with the Governor's involvement and State health
department, to talk about what we know, about public education,
prevention and treatment.
Since that time, we have made methamphetamine research
supplements. We have already found out more about
methamphetamine and violence, methamphetamine and heart
disease, methamphetamine and brain damage.
Because methamphetamine is a stimulant, we were able to
pick up on some of the clinical trials that we have been
conducting for cocaine in methamphetamine-using individuals,
and currently are conducting clinical trials on five different
potential medications, Tyrosine, Fluoxitine, Asertraline,
Desipramine, and Isridapine.
We are really hopeful that because we were able to move
quickly, that soon we will have some kind of answers and be
able to use that knowledge to apply to treatment populations,
as well as in prevention.
Complementary and Alternative Medicine
Senator Harkin. I appreciate that, because it seems that--
well, my time is up.
Just one last thing I would ask Dr. Kirschstein--Dr.
Klausner, I wanted to talk to you about some things.
But there is a list I have here from NIH talking about the
total number of dollars spent in complementary and alternative
medicine, not just in NCAM but in all of the institutes. It
totals about $160.7 million estimate for fiscal year 2000; NCI,
$38.4 million; and others.
I would like to have a little bit further breakdown about
what that all is for, what is happening in these areas, and how
these different offices are correlating with NCAM on this type
of research. I will not bore you, but just if you could give it
to me.
Dr. Kirschstein. We would be pleased to provide that.
[The information follows:]
Funding for Complementary and Alternative Medicine
Each NIH Institute and Center (IC) has designated a liaison for
complementary and alternative medicine (CAM) to provide scientific
input to, and facilitate coordination with the National Center for
Complementary and Alternative Medicine (NCCAM). NCCAM established the
Trans-Agency CAM Coordinating Committee, which serves as a forum for
facilitating research collaboration and coordination, not only across
the NIH, but across other major Federal health research entities as
well. The committee met on May 20, 1999; November 16, 1999; and April
6, 2000. Membership of the committee includes:
--the NIH IC CAM liaisons;
--representatives of several OD Offices [Office of AIDS Research
(OAR), Office of Behavioral and Social Sciences Research
(OBSSR), Office of Dietary Supplements (ODS), Office of Rare
Diseases (ORD), Office of Research on Minority Health (ORMH),
and Office of Research on Women's Health (ORWH)]; and
--liaisons from a number of other Federal Agencies [Agency for
Healthcare Research and Quality (AHRQ), Centers for Disease
Control and Prevention (CDC), Food and Drug Administration
(FDA), Health Resources and Services Administration (HRSA),
Indian Health Service (IHS), Substance Abuse and Mental Health
Services Administration (SAMHSA), U.S. Department of
Agriculture (USDA), U.S. Department of Education (ED), U.S.
Department of Defense (DOD), U.S. Department of Veterans'
Administration (VA), and the White House Commission on
Complementary and Alternative Medicine Policy].
Prior to the establishment of NCCAM, the ICs collaborated with the
NIH Office of Alternative Medicine (OAM) on a number of activities,
which included administration of OAM-supported research projects.
Below, each of the ICs have provided examples of their current research
collaborations with NCCAM and descriptions of their own CAM research
portfolios.
national cancer institute
NCI's research portfolio includes diverse activities performed in
many venues including: Comprehensive Cancer Centers, clinical trials
performed by the Cooperative Group and Community Clinical Oncology
Programs and research projects performed by scientists at a variety of
other academic institutions and corporations. Following are examples of
research activities supported by NCI in complementary and alternative
medicine:
Examples of CAM Clinical Trials
1. Phase III randomized trial of patients with prostate cancer to
study the effect of a diet low in fat and high in soy, fruits,
vegetables, green tea, vitamin E and fiber on prostate-specific antigen
(PSA) levels.
2. Phase II trial of patients with prostate cancer to study the
effects of dietary soy on biomarkers of prostate cancer.
3. Phase I and II trials using formulations of the active
components from green tea. Patient accrual began in December, 1999.
Examples of CAM Grants supported by NCI
1. Dietary Tomato Products and Experimental Prostate Cancer
2. Cohort Study of Dietary Supplements and Cancer Risk
3. Inhibition of Prostate Cancer Cell Growth by Vitamin D
4. Feasibility of Physioacoustic Therapy in Cancer Care
5. Mechanisms of Dietary Modulation of Melanoma Invasion
6. Menopausal Symptom Relief for Women with Breast Cancer
CAM Practice Assessment Program
1. Best Case Series Program--solicits and reviews case report data
of complementary and alternative medicine therapies that are felt by
their practitioners to be effective cancer therapies, and presents case
series to the Cancer Advisory Panel for Complementary and Alternative
Medicine.
2. Practice Outcomes Monitoring and Evaluation (POMES) projects--a
process used to follow-up on promising Best Case Series reviews. In the
pilot project, we will evaluate outcomes at the P Banerji Homeopathic
Research Foundation clinics in Calcutta, India using contract support
to monitor new lung cancer patients and obtain documentation and
follow-up of 30-50 new lung cancer patients for 12-18 months.
CAM Citation Database.--A project to explore the feasibility of
augmenting the cancer component of the existing NCCAM CAM Citation
Index versus establishing an independent NCI controlled cancer CAM
research database. This database will become a resource for NIH and
extramural investigators interested in CAM research and will include
articles and abstracts from many databases including Medline or Web of
Science. The database will serve as a resource for NIH and extramural
investigators interested in CAM research.
The Director of NCI's Office of Cancer Complementary and
Alternative Medicine (OCCAM) meets with the Director of the NCCAM every
two weeks to discuss ongoing and new collaborative projects. Also
several other projects funded by the NCI (e.g. the OCCAM Website, the
Practice Outcomes Monitoring and Evaluation System project in Calcutta
India, the NCI's Best Case Series Program) are discussed at these
meetings.
The Cancer Advisory Panel for Complementary and Alternative
Medicine (CAPCAM) was jointly constructed by the NCCAM and the NCI to
(1) review and evaluate summaries of evidence for CAM cancer claims
submitted by practitioners, (2) make recommendations to the NCCAM on
whether and how these evaluations should be followed up, and (3) be
available to observe and provide advice about studies supported by the
NCCAM and NCI, and about communication of the results of those studies.
The Panel's membership is drawn from a broad range of experts from the
conventional and CAM cancer research and practice communities. The
organization meeting for the CAPCAM was held November 1998. The panel
was subsequently chartered and is authorized to meet at least twice a
year. The first meeting of the chartered panel was held July 1999. For
fiscal year 2000, one CAPCAM meeting was held in December 1999 and a
second one is scheduled for late summer, 2000.
national heart, lung, and blood institute
NHLBI has had a long standing interest in complementary and
alternative medicine for heart, lung and blood diseases and has been
collaborating with the Office and now the National Center for
Complementary and Alternative Medicine since its inception. Because of
the elevation of NCCAM to the Center status, most research grants
initially funded by NCCAM and managed by NHLBI, have been reassigned to
NCCAM. Currently, NHLBI has a few primary applications, but has
secondary assignment on most new applications related to heart, lung
and blood diseases. In addition to grant support, NHLBI has been
involved in the following joint activities:
1. NHLBI is a co-sponsoring Institute for a PA ``Acupuncture
Clinical Trial Pilot Grants'', issued by NCCAM in 1998. Several grants
have been funded by NCCAM.
2. A workshop on the ``Complementary & Alternative Medicine in
Cardiovascular, Lung and Blood Research'', jointly sponsored by NHLBI
and NCCAM, is scheduled for June 12-13, 2000, to be held in Bethesda.
3. NHLBI and NCCAM jointly sponsor an RFA to encourage studies to
assess the efficacy of CAM, including acupuncture, herbal remedies,
homeopathy and magnesium supplement, in allergic disease and asthma.
4. NHLBI cosponsors an RFA on the Ginkgo Evaluation of Memory Study
with NCCAM and plans to provide funding in fiscal year 2000.
5. NHLBI continues to serve on a Trans-NIH Coordinating Committee
on Complementary & Alternative Medicine. This group reviewed planned
activities, helped to prioritize initiatives, and offered other
possible scientific directions to consider.
national institute of dental and craniofacial research
In fiscal year 1999, NIDCR funded a variety of research classified
as ``Complementary and Alternative Medicine''. The majority of this
funding was associated with research projects that addressed treatment
of pain associated with temporomandibular joint disorders.
NIDCR has worked with NCCAM to help develop their research
portfolio. For example, Institute staff participated with NCCAM in the
development of the Request for Applications for CAM Centers, which
stimulated the project P50 AT/DE00076 (White/Kaiser Research
Foundation-Craniofacial Complementary and Alternative Medicine Center).
In addition, NIDCR staff vigorously encouraged oral health researchers
to prepare CAM Center proposals, through contacting investigators,
suggesting potential collaborations, and disseminating information on
the CAM Center RFA at scientific meetings and in newsletters.
Similarly, NIDCR staff identified opportunities to stimulate
acupuncture research within pain research activities being conducted at
the University of Maryland, where several physicians and
neurophysiologists originally trained in China were initiating their
scientific careers under the mentorship of a world-recognized
neurophysiologist-dentist. The resulting project, funded by NCCAM, used
a dental (third molar extraction) pain model to compare patients' post-
operative pain relief after being given standard analgesics, sham
acupuncture, or real acupuncture.
national institute of diabetes and digestive and kidney diseases
The NIDDK is supporting research on several alternative or
complementary medicine strategies and has interest in their efficacy
and safety and in understanding their mechanisms of action and
interaction. Work on biofeedback is supported. There is close
collaboration with the NIH National Center for Complementary and
Alternative Medicine (NCCAM). Some specific examples include: (1)
Herbal Therapy for Benign Prostatic Hyperplasia (BPH): The NIDDK and
the NCCAM are jointly funding a clinical trial on the efficacy of saw
palmetto, over the period of August 1999 through July 2002; (2) Placebo
Effect: A trans-NIH workshop initiated by NIDDK, and jointly with the
NCCAM, is planned for November 20-21, 2000. The purpose of this
workshop is to develop a research agenda for placebo studies, and
prepare background papers summarizing the current status; (3) Herbal
Therapy for Liver Disease: The NIDDK and NCCAM will co-sponsor a
Request for Applications (RFA) that would develop a standardized
preparation of milk thistle for clinical studies of liver disease. In
addition, the NIDDK held a workshop on ``Complementary and Alternative
Medicine in Chronic Liver Disease,''on August 22-24, 1999, with support
from the NCCAM and the Office of Dietary Supplements (ODS). (4)
Chromium and Vanadium in Diabetes: In November 1999 the NIDDK co-
sponsored a meeting with the ODS on ``Diabetes and Chromium:
Formulating a Research Agenda.'' The workshop concluded that trials to
assess efficacy and studies to define cellular mechanisms are needed.
In 1992 the NIDDK issued an RFA to solicit research on vanadium;
several laboratories are investigating its effect on glucose
metabolism. (5) Botanical Research Centers: The Nutrition Branch of
NIDDK has indicated interest in participating in a Request for
Applications for Botanical Research Centers.
national institute of neurological disorders and stroke
NINDS funds 3 research grants in the area of complementary and
alternative medicine (CAM) research. These include a clinical trial on
vitamin intervention for stroke prevention and two grants on the
ketogenic diet as a treatment for epilepsy.
Brief summaries of these grants follow:
Vitamin Intervention for Stroke Prevention.--This is a multi-center
double-blind randomized controlled clinical trial to determine whether
the administration of a multivitamin with high dose folic acid,
pyridoxine, and cyanocobalamin, together with best medical management
and risk factor modification, can reduce the incidence of recurrent
stroke and myocardial infarction (MI) in patients with a first
nondisabling stroke who also have elevated homocyst(e)ine levels. This
is based on evidence that homocyst(e)ine is a risk factor for
atherothrombotic disease (and may be involved in the disease etiology),
and that elevated homocyst(e)ine levels can be reduced by vitamin
supplementation. Such an intervention has the potential to be an
inexpensive and safer alternative for preventing recurrent stroke and
MI, as compared to current warfarin or ticlopidine therapy.
Efficacy of the Ketogenic Diet--A Blinded Study.--This is a blinded
placebo-controlled study of the high-fat-low-carbohydrate ketogenic
diet to treat children with Lennox-Gastaut Syndrome, a refractory form
of epilespy characterized by atonic-myoclonic seizures. Preliminary
evidence suggests that the ketogenic diet is highly effective in
reducing seizure frequency. The study will test both the initial
efficacy of the diet (after 5 days) and whether seizure reduction can
be maintained over a longer period of time (after 6 months on the
diet).
Ketogenic Diet and Brain Amino Acid Metabolism.--This study is
investigating the mode of action of the ketogenic diet in a rat model.
The hypothesis is that the ketone bodies produced as part of the diet
reduce the rate of transamination of glutamate to aspartate. This has
the effect of reducing brain concentrations of aspartate, which is
excitatory, while increasing brain concentrations of GABA, which is
inhibitory. This is being studied in rat pups being fed the ketogenic
diet. In addition, the efficacy of the ketogenic diet to reduce
seizures in a rat model of epilepsy is also being studied.
NINDS is a member of the newly formed trans-NIH CAM Coordinating
Committee, which meets regularly to identify opportunities for trans-
Institute collaboration on activities and initiatives related to CAM.
In addition, NINDS staff have worked closely in the past with NCCAM
staff on several joint initiatives, including a Request for
Applications (RFA) for Centers for Mind/Body Interactions and Health,
and another RFA for Centers for Complementary and Alternative Medicine
Research. An NINDS staff liaison also regularly attends study section
(i.e., peer review) meetings of neurology related CAM grants.
national institute of allergy and infectious diseases
The NIAID supports complementary and alternative research efforts
in areas that coincide with its own research priorities. The Institute
expects to spend $8 million in this area in fiscal year 2000, and the
following research examples reflect NIAID's interest in pursing
research advances in its own targeted areas of research, with the help
of complementary and alternative medicine.
--The NIAID is supporting research on Siberian Ginseng at the
University of Iowa. Investigators are examining the use of
Siberian Ginseng for the treatment of chronic fatigue syndrome,
and evaluating whether subjects with idiopathic chronic fatigue
will respond to Siberian Ginseng, a widely recommended herb for
the treatment of fatigue.
--The NIAID is supporting research at the University of Cincinnati to
determine the impact of dietary supplements on kidney graft
survival and incidence and severity of post-transplant adverse
events. To date, this pilot study has enrolled 20 patients and
has shown a 77 percent reduction in the number of recipients
having an acute rejection, leading to a 50 percent reduction in
the number of biopsies for renal dysfunction. In addition, a
significant reduction in the number of post-transplant
infectious complications was also observed.
--An international workshop, The Importance of Omega-3 Fatty Acids in
the Attenuation of Immune-Mediated Diseases, will be co-
sponsored by the NIAID, the NIH Office of Dietary Supplements
and the National Center for Complementary and Alternative
Medicine, and will be held in fiscal year 2000. The primary
goal of this workshop is to establish research plans for
definitive, mechanisms-based, preclinical studies and clinical
trials to elucidate the mechanisms whereby omega-3 fatty acids
attenuate immune-mediated diseases. Fish and other marine life
are rich sources of a special class of polyunsaturated fatty
acids known as the omega-3 or n-3 fatty acids. Reports suggest
that dietary omega-3 fatty acids may have potent anti-
inflammatory activities in inflammatory disorders such as
transplant rejection, autoimmune and allergic diseases. The
workshop will include investigators from the United States and
other countries, who will participate in the discussions to
review the current knowledge and clinical trial results.
Further discussions will focus on setting research priorities
and formulating research plans to accelerate focused studies in
this area. The workshop proceedings will be published, and
proposed initiatives for new preclinical studies and clinical
trials will be developed for funding consideration by NIH
Institutes and Centers.
--The NIAID is providing funds to the University of California,
Davis, to develop the Asthma-Alternative Medicine Center. The
Center will serve as a U.S. and international resource to
assist alternative medicine practitioners and researchers in
identifying potential treatments and for developing protocols
to evaluate the efficacy of unconventional medical practices
using nutrition, ethnomedicine, and immunopharmacology for the
treatment of asthma. The Center will include studies on: the
effect of vitamin C on pulmonary function and quality of life
on patients with mild asthma; oral immunotherapy of grass
pollen allergy using wheatgrass juice; and the influence of
botanical and glandular extracts on cytokine biosynthesis and
cytotoxicity.
It is customary for staff at the NIAID to interact with staff at
the NCCAM on complementary and alternative medicine disciplines. For
example, the NIAID program staff will consult with the NCCAM program
staff about grant applications that cut across both the Institute and
the Center.
national institute of child health and human development
The National Institute of Child Health and Human Development
(NICHD) sponsors a variety of research projects to study complementary
and alternative medicine (CAM). These span the life cycle, and include
studies to: investigate the use of yoga to improve the pulmonary
function in asthmatic women during pregnancy; evaluate the use of
supportive birth companions and soft infant carriers to foster
parenting skills and maternal/infant attachment; and test the
hypothesis that muscle strength improvement in the elderly depends more
on mental effort than training intensity. The latter has implications
in rehabilitation of stroke victims. Other studies focus on pain
management. One such study evaluates cognitive-behavioral treatments
for pain reduction (relaxation training, parent education, stress
management and thermal biofeedback) in children with recurrent
migraines or abdominal pain. Another looks at the effects of manual
therapies combined with specific exercises to treat chronic back pain.
A third studies the effects of antioxidants (Vitamins C and E) on the
pathogenesis of endometriosis, a disorder that inflicts pain and may
cause infertility in women.
The NICHD has a representative on the NCCAM Trans-Agency
Coordinating Committee, who attends NCCAM's regular meetings,
participates in discussions of joint initiatives, strategic planning
and collaborative workshops. In addition, the NICHD staff administers
several large center grants in collaboration with NCCAM to evaluate the
effectiveness of CAM therapies, for conditions within the mission of
the NICHD, and teach research methods and provide clinical research
training and mentoring programs to clinicians who employ CAM.
national eye institute
In fiscal year 1999 NEI-supported complementary and alternative
medicine research that was principally focused on the role of nutrition
and dietary supplements on prevention and treatment of progressive
blinding eye diseases such as macular degeneration and cataract.
Specifically, researchers are investigating the role glutathione, an
antioxidant, has for protecting the retinal pigment epithelium from
oxidative stress. This research may advance our understanding of the
pathogenesis of Age-Related Macular Degeneration (ARMD) and provide
information for the development of treatments for ARMD. Researchers
supported by the NEI are also conducting an epidemiological study to
evaluate the relationship between nutritional factors and ARMD in the
United States, and the results of this research will be useful for the
development of future clinical trials on nutritional intervention of
this blinding disease. The NEI also supported research on the
biochemistry and pharmacology of macular carotenoids. This research
will investigate the biochemical processes responsible for the specific
deposition of lutein and zeazanthin in the macula with special emphasis
on the search for potential carotenoid-binding proteins. The results of
this study will provide new insights on the uptake of lutein and
zeazanthin into the macula, and may lead to the development of
therapies that take advantage of these uptake systems to retard or
prevent blindness resulting from macular and other retinal degenerative
diseases. The NEI also funded research on the use of antioxidant
supplements on the prevention of cataract progression. Additionally,
the NEI reports to NCCAM on studies of the impact of dietary
supplements on vision and visual disorders. NEI staff participate in
NCCAM workshops.
national institute of environmental health sciences
The National Institute of Environmental Health Sciences (NIEHS) has
several objectives regarding complementary and alternative medicine:
--Assess toxicity of common herbal preparations, particularly their
ability to cause reproductive, neurological and immunological
toxicity
--Assess the health consequence of long-term, chronic use of herbal
preparations.
--Define herb/herb and herb/drug interactions, particularly in
sensitive subpopulations.
--Identify the molecular basis of herbal efficacy and toxicity.
Furthermore, the NIEHS, in conjunction with the National Toxicology
Program (NTP), will design and initiate studies to identify and
characterize possible adverse health effects that may be associated
with prolonged use or higher doses of some of the most popular
medicinal herbs, including aloe vera, comfrey tea, androstenedione,
Ginkgo biloba, echinacea, and Panax quinquefolius (American ginseng).
The NIEHS sponsored a workshop called International Workshop to
Evaluate Research Needs on the Use and Safety of Medicinal Herbs with
the NTP; NIH's Office of Dietary Supplements and its Office of Research
on Women's Health; the Department of Health and Human Services' Office
of Disease Prevention and Health Promotion; the Food and Drug
Administration's Office of Special Nutrition; and the Society for the
Advancement of Women's Health Research.
Currently, medicinal herbs are not subject to testing requirements
for effectiveness or safety. This workshop succeeded in bringing
together an international panel of experts to discuss necessary
research to address public health concerns related to their use. In
follow-up to this workshop, the NIEHS and NTP are working with NCCAM,
the NIH Office of Dietary Supplements, FDA, the academic community, and
others to further define and implement research that addresses
deficiencies in our knowledge about herbal medicines and their
potential toxicities.
national institute on aging
In fiscal year 1999, NIA funded a variety of areas related to
complementary and alternative medicine including: investigations of the
effects of culture and ethnicity on health care practices and treatment
choices for diseases such as cancer and HIV infection; the use of
phytoestrogens instead of estrogen replacement therapy for the
prevention of menopausal symptoms and bone loss; the use of vitamin E
to prevent atherosclerosis, cognitive decline in women, and infection;
the effects of religion on health; and the use of tai chi to prevent
falls.
The Director, NCCAM has met with the Director, NIA, individually,
and with NIA senior scientific program staff at a special meeting to
discuss areas of potential scientific collaboration. An NIA staff
person serves as an official NIA liaison to NCCAM to work on
collaborative activities including the development of a conference on
the placebo effect. Other specific areas of collaboration that are
being pursued in fiscal year 2000 include the addition of a set of
questions on the use of complementary and alternative medicine to the
NIA Health and Retirement Survey; an ongoing program announcement on
medication use by the elderly; and a randomized, controlled trial of
ginkgo biloba in preventing Alzheimer's disease.
national institute of arthritis and musculoskeletal and skin diseases
There is substantial interest on the part of the American public in
alternative therapies, particularly for people with chronic diseases of
bones, muscles, joints and skin. For example, scientists have reported
that green tea products show anti-inflammatory activity in mouse
models. Rheumatoid arthritis is an example of an inflammatory condition
affecting joints, resulting in pain and, over time, destruction of
joints. Results of recent research suggest that identification of
common dietary substances, such as green tea products, capable of
affording protection or modulating the onset and severity of arthritis,
may be used in the future to treat or prevent rheumatoid arthritis.
Another promising area of alternative medicine being pursued by NIAMS-
funded scientists is an evaluation of the effects of acupuncture on
carpal tunnel syndrome.
NIAMS has enjoyed substantial collaboration with NCCAM since the
inception of the OAM at NIH in 1992. For example, NIAMS co-funded with
OAM three of the original Centers on Alternative Medicine--the Center
of Alternative Medicine for Pain Research and Evaluation at the
University of Maryland, the Center to Assess Alternative Therapy for
Chronic Illness at Beth Israel Hospital, and the Complementary and
Alternative Medicine Research Center at Stanford University. In
addition, the NIAMS and OAM jointly established the Chiropractic
Consortium at the Palmer College of Chiropractic in Iowa. Furthermore,
we have teamed with our colleagues in alternative medicine to fund
several conferences in this area, including the NIH Consensus
Development Conference on Acupuncture in November 1997, and the NIH
Pain Consortium symposium ``New Directions in Pain Research'' in
November 1997. Finally, the NCCAM and NIAMS have jointly issued a
number of solicitations to stimulate research in alternative medicine.
These include an RFA on Acupuncture Treatment for Osteoarthritis; and
very recently, a solicitation and contract award to study the efficacy
of glucosamine and chondroitin sulfate in osteoarthritis. This is a
significant area of interest and concern for the American public, and
the NIAMS and NCCAM staff have launched a study to provide a solid
scientific basis in determining the value of these widely-used
compounds in people with osteoarthritis.
national institute on deafness and other communication disorders
The NIDCD is currently supporting one research project involving
alternative and complementary approaches to communication and sensory
disorders. The long term goals of this study are to understand the
epidemiology of otitis media (OM) and hearing loss among Native
Americans from birth to age two and to define the relative importance
of known and new risk factors in this population. Native Americans have
a high prevalence of chronic otitis media, but prospective studies of
OM among infants and young children, of this group are sparse. The risk
factors under study include both environmental factors such as smoking
by parents as well as genetic factors that may be specific to Native
Americans.
Questionnaires are one mechanisms used in the study to collect
information. The questionnaires ask if pregnant mothers are taking
``traditional'' Native American medicines. Such medicines include:
sage, tea from medicine man, swamp tea; sweet grass; cedar tea; bear
root; blue spruce; pregnancy tea; sumac; echinacea tea; and raspberry
leaf tea. Mothers are also asked whether their children have been given
any ``traditional'' Native American medicines, but the specific types
are not asked for in the questionnaire. The answers on the
questionnaire will eventually be used to determine if there is any
correlation between the frequency of otitis media and the use of
``traditional'' Native American medicines. Approximately 5 percent of
the project is devoted to the determination of possible effects of
Native American traditional medicines.
The NIDCD is currently planning a workshop with the National Center
of Complementary and Alternative Medicine (NCCAM) for fiscal year 2001
to explore the use of T'ai Chi (TC) and other alternative therapeutic
modalities (e.g., Chi Kung, yoga, dance therapy) in the treatment of
balance disorders. The collaboration of other Institutes, including the
National Center of Medical Rehabilitation Research (NCMRR) of NICHD and
the NIA has also been sought. There are reports in the literature
suggesting that TC is effective in maintaining or improving balance in
unstable individuals and in improving falls in the elderly. This
workshop will explore the promise of such approaches as efficacious and
low-cost alternatives to conventional physical rehabilitation and
sensory substitution programs, the latter oftened termed, ``vestibular
rehabilitation.'' It will shed light on a long-standing question in the
balance rehabilitation field: Should balance be trained as an isolated
function or within the context of ``acts of daily living.''
The NIDCD has a representative serving on the Trans-agency
Complementary and Alternative Medicine Coordinating Committee (TCAMCC).
national institute of mental health
The National Institute of Mental Health (NIMH) supports research
that explores the potential usefulness of complementary and alternative
medicine approaches to the treatment of mental disorders and to mental
and behavioral aspects of other serious illnesses. In fiscal year 1999,
NIMH CAM research included:
CAM approaches to treatment of depression
Saint John's Wort (SJW), or hypericum, a popular naturotherapy for
depression in Germany, is being widely used in the UnitedStates.
Previous controlled trials have indicated SJW does reduce symptoms of
depression in adults, although definitive data on its efficacy are
lacking and there are no scientific reports of the effectiveness,
safety, and tolerability of SJW in children or adolescents. NIMH is
collaborating with the NCCAM in the conduct of a three-arm, placebo-
controlled, clinical efficacy study of a standardized extract of
hypericum in major depression. This trial is designed to test the acute
efficacy and safety of hypericum compared to placebo. In another pilot
study, NIMH-supported researchers are exploring the benefits of SJW as
a possible non-pharmaceutical treatment for depression in youths ages
6-16.
Exposure to light appears to offer promise for the treatment of
winter depression (Seasonal Affective Disorder, or SAD), although the
mechanism of the effect or the optimal scheduling of light exposure
with respect to an individual's circadian phase has not been
determined. NIMH-supported researchers are studying the mechanisms and
timing of light therapy for best results. Other investigators funded by
NIMH are determining if therapeutic sleep deprivation (TSD) can
accelerate the response of depressed geriatric patients to an
antidepressant (paroxetine). In other work, investigators are examining
the relationship of exercise to depression in a general population, and
the efficacy of exercise as a treatment for people with mild-to-
moderate depressive disorder.
CAM approaches to other mental and medical disorders
For mental disorders other than depression, NIMH-supported
researchers are assessing the efficacy of Eye Movement Desensitization
and Reprocessing (EMDR) for treatment of post-traumatic stress disorder
(PTSD) and the efficacy of hypnosis as an adjunct to traditional forms
of psychotherapy. NIMH-supported ethnographic research aims to
understand the therapeutic change processes in three forms of religious
healing in Navajo society. For serious medical disorders, researchers
are exploring the ability of peer support to enhance adherence to
treatment for HIV/AIDS and the ability of cognitive-behavioral stress
management (CBSM) to reduce acute stress responses in HIV-positive
individuals, focusing on low socioeconomic status minority and
substance-abusing individuals. Additional research evaluates the
benefits of psychosocial and psychoeducational interventions to cancer
patients both for pre-surgical stress reduction for men undergoing
surgical treatment of prostate cancer and on survival for women
recovering from metastatic breast cancer.
NIMH collaborates closely and actively with NCCAM on those CAM
studies of interest to the Center, such as the Saint John's Wort
clinical trial. For more exploratory CAM studies focused on limited-
scope aspects of mental health research, communication with NCCAM is
encouraged by NIMH at all times.
national institute on drug abuse
The National Institute on Drug Abuse estimates that it spent $0.4
million on complementary and alternative medicine grants in fiscal year
1999. NIDA plans to encourage more research on this important and often
cross-cutting topic area. NIDA is interested in determining the
efficacy of treatments for substance abuse, including those that take
on a more ``complementary or alternative'' approach to treating the
complex problem of addiction. Currently NIDA has two research grants
that focus on alternative therapies, specifically the role that
acupuncture plays in treating addiction. One of NIDA's grantees is
looking at the role that auricular acupuncture can play in reducing
cocaine use among HIV-positive patients in methadone-maintenance
programs. The other grant is researching the role that electro-
acupuncture can play in alleviating pain.
NIDA has had a relationship with the staff from the former NIH
Office of Alternative Medicine for several years. In fact, NIDA was one
of the co-sponsors for the NIH Consensus Development Conference on
Acupuncture that was held in November 1997. NIDA staff continues to
collaborate with NCCAM staff in a variety of formal and informal ways
including through NIDA representation on the NCCAM Trans-agency CAM
Coordinating Committee. NIDA is also collaborating with the National
Center for Complementary and Alternative Medicine (NCCAM) and the
Office of Dietary Supplements (ODS) to sponsor a meeting later this
summer to examine intervention modalities (chemo and alternative) in
drug abuse and HIV/AIDS.
national institute of nursing research
The National Institute of Nursing Research (NINR) funds a number of
research studies in the area of complementary or alternative medicine.
Two studies are co-funded with NCCAM. One addresses the use of
melatonin for sleep disorders in patients with Parkinson's disease. The
other study addresses whether the setting of a breast cancer support
group for African-American women can trigger self-transcendence to
enhance quality of life.
Other studies supported by NINR include a model of wellness circles
for Native American Indian families to promote prevention of disease;
the effects of relaxation therapy on the immune system and quality of
life of caregivers of patients with Alzheimer's disease; the effects of
relaxation and music on postoperative pain; the benefits of
acupuncture, massage therapy, vitamins, herbs and nutritional
supplements, in addition to traditional care, on those at the end of
life; and the effects of cancer pain interventions that include guided
imagery, attention diversion, and relaxation.
NINR research initiatives for fiscal year 2001 include self-
management strategies and end-of-life palliative care. Future CAM areas
of interest could involve evaluation of mind-body interventions for
patients with chronic illness or who are at the end of life stage.
In addition to collaborations with NCCAM on research projects, NINR
serves on the NCCAM Trans-Agency CAM Coordinating Committee, which
meets three times a year to discuss initiatives and projects of mutual
interest.
national center for research resources
The NCRR creates, develops, and provides a comprehensive range of
human, animal, technological, and other resources to enable biomedical
research advances. The NCRR serves as a ``catalyst for discovery'' for
NIH-supported investigators by supporting resources in four areas:
Biomedical Technology, Clinical Research, Comparative Medicine, and
Research Infrastructure. Three of these areas currently support
research resources that enable multidisciplinary collaborations and
discoveries in many areas of health relating to CAM.
Clinical Research
The Clinical Research area, through its national network of 77
General Clinical Research Centers (GCRCs), supports CAM related
clinical investigations such as biofeedback in advanced heart failure
(Ohio State University); effects of melatonin in human sleep behavior
(Massachusetts Institute of Technology); and, soybean diets and breast
cancer prevention in women (University of Texas at Galveston). Other
studies include the use of hypnosis as an adjunct to periodontal
therapy, acupuncture for the treatment of HIV associated diarrhea and
the effect of therapeutic back massage on the immune function of cancer
patients.
The GCRC Program encourages funded investigators from NCCAM
supported Centers such as the CAM Centers at the University of Michigan
and the Addictions Center at Minneapolis to utilize the resources of
the GCRCs. Many other NCCAM funded investigators are co-located with,
or nearby, GCRCs such as the GCRCs at the University of Virginia,
University of Washington Seattle, Brigham Women's Hospital, University
of California San Diego, and the University of Indiana, just to name a
few.
Biomedical Technology
The Biomedical Technology area of NCRR supports state of the art
technologies and methodologies that create, develop, and provide a wide
range of complex technological capabilities. Examples are studies of
acupuncture in humans using magnetic resonance imaging (MRI) and
magnetic resonance spectroscopy (MRS) at the University of Pennsylvania
and the characteristics of antioxidant compounds from natural products
at Michigan State University. NCCAM currently supports an Intramural
fellow (Dr. Joannie Shen) to study the effects of acupuncture for the
treatment of alcoholism using functional MRI. This topic, or others
similar to it, could potentially be supported by the regional imaging
centers funded by Biomedical Technology and the GCRC Program. Dr. Shen
is now performing her studies at the NIH Clinical Center.
Research Infrastructure
The Research Infrastructure area, through its Research Centers in
Minority Institutions (RCMI) Program, supports research at the
University of Hawaii in the use of energy healing in very low birth-
weight infants as well as the use of distant healing in breast and
prostate cancer patients receiving radiation. The University of Hawaii,
as well as some other RCMI institutions, such as Drew and the
University of Puerto Rico have been applicants to NCCAM for a variety
of grants including Center support.
fogarty international center
FIC's longstanding Biodiversity and AIDS programs support
complementary and alternative medicine in the form of research on
herbal therapies utilized by indigenous peoples in several nations,
including Nigeria, Mexico, Chile, and Laos. Herbal medicines used for a
variety of indications relevant to infectious diseases, cancer, pain,
and Alzheimer's disease are explored for efficacy and safety in
laboratory studies in developing countries and in the United States,
including those of industrial pharmaceutical partners.
Given that CAM is used extensively abroad as well as in the United
States, the FIC Director (who also serves as the NIH Associate Director
for International Research) and the Director of NCCAM have discussed on
several occasions common interests and the possibility of future joint
initiatives examining the international role and resources available
for study of CAM. In addition, FIC staff work to facilitate
international dialogue between NCCAM and foreign counterparts,
including those in China. Also, the FIC program director for
Biodiversity works with the staff of NCCAM to ensure that relevant
information is shared among interested groups.
Senator Harkin. Thanks.
Senator Specter. On the questions which I have asked, I
would like two additional answers in writing. One is what you
have been able to accomplish with the increases in funding over
the last 3 years, which for the total number of institutes,
aggregate more than $5 billion. Of course, it breaks down to
different figures.
I would like to have the increase actually for each of the
institutes over the 3 years, what you have been able to
accomplish with that extra, and what you would look forward to
accomplishing if you got your wishes on the funding to have the
total number of grants that you would like to see.
[The information follows:]
Past and Future Accomplishments
The following table reflects each institute and center budget
increases over the last three years, to include fiscal years 1998-2001.
NATIONAL INSTITUTES OF HEALTH FUNDING BY INSTITUTE AND CENTER
[In thousands of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year
---------------------------------------------------------------------------------------------
Institute 1998 1999 2000 2001
---------------------------------------------------------------------------------------------
Actual Change Actual Change Estimate Change Estimate Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
NCI....................................................... 2,551,281 162,240 2,891,570 340,289 3,311,687 420,117 3,505,072 193,385
NHLBI..................................................... 1,526,276 94,455 1,774,827 248,551 2,026,430 251,603 2,136,757 110,327
NIDCR..................................................... 210,172 13,109 238,001 27,829 269,185 31,184 284,175 14,990
NIDDK..................................................... 896,686 83,622 1,021,006 12,4,320 1,141,415 120,409 1,2D9,173 67,758
NINDS..................................................... 778,432 49,183 896,921 118,489 1,029,743 132,822 1,084,828 55,085
NIAID..................................................... 1,352,119 94,326 1,570,530 218,411 1,796,631 226,101 1,906,213 109,582
NIGMS..................................................... 1,061,505 66,116 1,202,800 141,295 1,353,943 151,143 1,428,188 74,245
NICHD..................................................... 672,073 40,811 752,179 80,106 859,258 107,079 904,705 45,447
NEI....................................................... 354,153 22,566 395,604 41,451 450,101 54,497 473,952 23,851
NIEHS..................................................... 328,711 21,156 387,640 58,929 442,688 55,048 468,649 25,961
NIA....................................................... 517,082 32,764 599,720 82,638 687,861 88,141 725,949 38,088
NIAMS..................................................... 273,879 17,687 305,976 32,097 349,480 43,504 368,712 19,232
NIDCD..................................................... 199,786 11,569 230,803 31,017 263,661 32,858 278,009 14,348
NIMH...................................................... 748,329 47,572 854,184 105,855 974,673 120,489 1,031,353 56,680
NIDA...................................................... 536,852 37,539 617,409 80,557 687,376 69,967 725,467 38,091
NIAAA..................................................... 226,224 15,031 259,258 33,034 293,234 33,976 308,661 15,427
NINR...................................................... 63,340 3,789 69,851 6,511 89,539 19,688 92,524 2,985
NHGRI..................................................... 218,340 29,431 283,638 65,298 335,862 52,224 357,740 21,878
NCRR...................................................... 452,193 38,144 560,716 108,523 675,054 114,338 714,192 39,138
NCCAM..................................................... .......... ........ 50,531 50,531 69,011 18,480 72,392 3,381
FIC....................................................... 28,190 1,690 35,164 6,974 43,328 8,164 48,011 4,683
NLM....................................................... 161,606 11,499 181,770 20,164 215,199 33,429 230,135 14,936
OD........................................................ 295,194 9,331 255,635 (39,559) 282,000 26,365 308,978 26,978
---------------------------------------------------------------------------------------------
Subtotal.............................................. 13,452,423 903,630 15,435,733 1,983,310 17,647,359 2,211,626 18,663,835 1,016,476
B&F....................................................... 234,436 12,458 197,456 (36,980) 165,376 (32,080) 148,900 (16,476)
---------------------------------------------------------------------------------------------
Total................................................. 13,686,859 916,088 15,633,189 1,946,330 17,812,735 2,179,546 18,812,735 1,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
In response to the second part of your question, listed below are
descriptions of Institutes and Centers current accomplishments and what
could be accomplished with with additional resources.
national cancer institute
The National Cancer Institute (NCI) conducts, coordinates and funds
cancer research, and provides vision and leadership for the cancer
research community both in the United States and abroad.
Accomplishments
The incidence and death rates for all cancers combined declined
between 1990 and 1996, reversing an almost 20-year trend of increasing
cancer cases and deaths in the U.S.
To date, we have catalogued approximately 70,000 genes that are
expressed in the development of cancers; of these, about 30,000 are
previously unknown genes.
Scientists uncovered evidence, using the new science of cancer
genomics, that diffuse large B-cell lymphoma is actually two distinct
diseases. This has important implications for their treatment.
Tamoxifen, a drug long used to treat breast cancer, led to a 49
percent reduction in the incidence of primary breast cancer during the
treatment period in women at high risk for the disease.
Last year, NCI supported over 1,500 clinical trials in prevention
and treatment, covering virtually all human cancers. The results of
clinical trials over the past two years have set new standards for
regimens to treat childhood cancers, leukemia, myeloma, breast cancer,
and others.
What Could Be Accomplished With Additional Funds
Priority for new resources would be given to developing cancer
prevention interventions for children under 10 years of age, when they
are most receptive to parental and adult influences. Opportunities for
prevention of cancer include tobacco use, sun exposure, and diet and
nutrition.
Additional funding will greatly enhance NCI plans to increase the
number of clinical trials and the number of patients who enroll in
trials.
NCI's Tumor Gene Index will catalog the genetic characteristics of
tumors at each stage of growth. NCI also hopes to change the system of
tumor classification from a visual to a molecular basis.
Today, NCI can support approximately only the top 30 percent of
grants in the research project grant pool. More support for all types
of investigator-initiated research remains a fundamental need.
Additional resources are needed to expand NCI's Surveillance,
Epidemiology, and End Results (SEER) database to enhance coverage of
rural whites and blacks, non-Mexican Hispanics and Native Americans.
New initiatives are aimed at training scientists that cross
disciplinary boundaries to meet the complex challenge of cancer, at
training physicians in the skills of clinical research, and at
attracting increased numbers of minority students and young scientists
into all aspects of cancer research.
national heart, lung, and blood institute
Accomplishments
A newly developed procedure called cardiac magnetic resonance
imaging will allow cardiologists in hospital emergency rooms to make
faster and more accurate assessments that could mean the difference
between life and death when a person comes into the hospital with
symptoms of a heart attack.
Recently, the first totally implantable, mechanical heart-assist
device was successfully placed in a patient who was no longer eligible
to receive an organ transplant due to the advanced stage of his heart
disease.
A recent study showed the benefits of teaching children early about
eating a healthy diet and getting plenty of physical exercise. Three
years afterward, children in the study continued to eat healthier food
and get more exercise than their peers. The researchers concluded that
giving the children occasional, positive reinforcement will help them
maintain their healthy lifestyles throughout junior high, high school,
and beyond.
A recent technological leap in blood testing called Nucleic Acid
Testing, or NAT, screens donated blood to detect the presence of genes
for the hepatitis and AIDS viruses. NAT detects even minute levels of
virus, making the safest blood supply ever even safer.
A breakthrough in ventilator management offers both better survival
in patients with acute respiratory distress syndrome (ARDS) and
substantial monetary savings due to faster recovery and less time spent
in costly intensive care units.
Two new ways have been found to determine who is at high risk for
sudden cardiac death (SCD), which kills 300,000 Americans annually,
often striking without warning in young, seemingly healthy people. The
screening techniques can easily be incorporated into routine physical
exams. Once a person is found to be at risk for SCD, appropriate
preventive therapy can be prescribed.
What Could Be Accomplished With Additional Funds
Three phase I clinical trials are in progress to test the safety of
using gene therapy to treat hemophilia, which affects 20,000 Americans.
A new treatment can stimulate the development and growth of new
blood vessels for the heart. This treatment may one day eliminate the
need for the more invasive, risky, and costly angioplasty and bypass
procedures currently used to treat heart disease.
The Action to Control Cardiovascular Risk in Diabetes (ACCORD)
trial aims to gain a better understanding of how to reduce risks of
heart attack and stroke in patients with type 2 diabetes. The goal is
to find the most effective ways to normalize blood sugar and improve
blood pressure and cholesterol levels, thereby helping diabetics enjoy
longer, healthier lives.
national institute of dental and craniofacial research
The National Institute of Dental and Craniofacial Research (NIDCR)
seeks to improve and promote craniofacial, oral, and dental health
through research.
Accomplishments
A recent NIDCR-sponsored study has revealed a mutation in the PAX9
gene that results in the absence of molar teeth. This discovery brings
scientists a step closer to understanding human tooth development.
New studies sponsored by the NIDCR showed that the hormone estrogen
can reverse problems associated with wound healing in the elderly.
New studies have found mutations in the cathepsin C gene that cause
Papillon-Lefevre syndrome, a genetic disorder that typically affects
both the skin and teeth. In some cases, all primary teeth are lost by
age 4 and all permanent teeth are lost by age 14. This research
suggests possible future therapies.
What Could Be Accomplished With Additional Funds
What Could Be Accomplished With Additional FundsNIDCR recently
issued a Request for Applications for Centers for Research to Reduce
Oral Health Disparities for fiscal year 2001 funding. The centers will
support research to investigate dental, oral, and craniofacial health
disparities and design interventions to reduce them.
Scientists have already identified a large number of genes
associated with craniofacial-oral-dental diseases and disorders. NIDCR
is poised to pursue the next phase of genetic research, which deals
with the complex gene-gene and gene-environment interactions that
control craniofacial development.
NIDCR is exploring the suggested link between periodontal disease
and the birth of preterm, low birth weight babies. It is also
evaluating the benefits of periodontal disease treatment in women at
high risk for delivering prematurely.
NIDCR will support statewide models of oral cancer prevention and
early detection, and collect the knowledge and opinions of health care
professionals and the public about the disease. NIDCR will support
statewide models of oral cancer prevention and early detection, and
collect the knowledge and opinions of the public and health care
professionals about the disease.
In the future, testing saliva may be a simple way of obtaining
medical diagnostic information. NIDCR scientists are investigating new
ways to analyze saliva and incorporate saliva testing into trials and
other clinical settings.
The NIDCR biomimetics program aims to mimic biological processes to
repair body parts and help fight infectious diseases and inherited
disorders. It will promote new research into restoring oral, dental,
and craniofacial structures, and into molecular technologies to deliver
drugs and genes to combat infectious diseases, cancers, and
craniofacial disorders.
national institute of diabetes and digestive and kidney diseases
Accomplishments
Replacement of insulin-producing beta cells through regeneration or
transplantation could offer lifelong treatment for type 1 diabetes.
Recent studies in animals demonstrated a drug that led to long-term
acceptance of these cell transplants, opening the possibility of new
treatments for type 1 diabetes in humans.
Genetic studies of type 2 diabetes have found single gene mutations
that cause rare forms of the disease in the young.
An NIDDK intramural scientist has recently discovered gene
``insulators'', which allow genes to be expressed without interference
from surrounding genetic material. This discovery is of particular
importance to the biotechnology industry.
An obese child with a congenital leptin deficiency was treated
successfully with leptin therapy, resulting in decreased appetite,
increased physical activity, and significant weight loss.
Scientists reported a treatment in an animal model of Polycystic
Kidney Disease (PKD) that prevents cyst formation and dramatically
enhances survival. This new finding has clear implications for treating
human PKD, the fourth leading cause of end-stage renal disease.
Scientists successfully demonstrated a genetically-engineered
treatment called infliximab for Crohn's disease, an inflammatory bowel
disease.
What Could Be Accomplished in the Future with Additional Funds
NIDDK is co-sponsoring a number of initiatives to develop new
transplantation strategies to treat type 1 diabetes and improve the
success of liver and kidney transplantation.
NIDDK will support research to understand the differences in type 2
diabetes and obesity among racial and ethnic groups, with a view toward
developing interventions.
Rates of hepatitis C infection are two to three times higher in
African Americans than in Caucasians, and the response rate among
African Americans to interferon therapy is far less than among
Caucasians. NIDDK plans to expand research to address the causes of
this ``resistant pattern''.
NIDDK will encourage research into cell and tissue development, and
into the use of stem cells to combat disease.
NIDDK will expand its research on autoimmune diseases, including
type 1 diabetes, autoimmune renal disease, autoimmune hepatitis,
autoimmune thyroid disease, and inflammatory bowel disease.
national institute of neurological disorders and stroke
The National Institute of Neurological Disorders and Stroke (NINDS)
seeks to reduce the burden of neurological disorders through research.
Accomplishments
Scientists identified a gene that causes narcolepsy in dogs, one of
the few species besides humans susceptible to narcolepsy. This
discovery may make it possible to design a drug to treat the condition.
Scientists showed that reducing corticosteroid hormone levels in
aged rats restored the rate of nerve cell growth in the brain's
hippocampus region to nearly the same level as in young animals. This
work suggests new avenues for preventing memory loss in aging.
A study into the factors that influence the likelihood that an
aneurysm will burst will allow some patients to avoid possibly
dangerous surgical intervention.
Scientists have found a chemical signal that helps brain cells
tolerate ischemia, a loss of adequate blood supply to the brain that
causes strokes. This chemical, ceramide, presents a new strategy to
reduce the damage caused by stroke.
Scientists gained new insights into a structure called the M
channel, revealing the cause of one form of epilepsy. This finding
opens the door for developing new epilepsy treatments.
What Could Be Accomplished With Additional Funds
A National Neuroscience Center will bring basic research findings
to clinical application by promoting collaboration, communication, and
shared resources.
NINDS is developing initiatives to exploit new understanding of the
nerve cell circuits in the spinal cord and of the cellular mechanisms
that promote spinal regeneration.
Tests must be developed to detect prions, which cause Creutzfeldt-
Jakob disease and other neurodegenerative diseases, in the blood
supply.
Therapies using neural stem cells have shown tremendous promise in
animal models of such human diseases as Tay-Sachs, Parkinson's, and
spinal cord injury.
Efforts to reduce health disparities will focus on HIV/AIDS and on
preventing and treating stroke in minority populations. Supporting
Specialized Centers for Neuroscience Programs at minority institutions
will be vital in this endeavor.
A multi-institute study of cognitive and emotional health over the
life span will improve our ability to identify people who may benefit
from early intervention or preventive measures to improve brain
function and delay or prevent disease.
national institute of allergy and infectious diseases
The National Institute of Allergy and Infectious Diseases (NIAID)
supports research to develop better ways to diagnose, treat and prevent
infectious, immunologic and allergic diseases.
Accomplishments
A single oral dose of the relatively inexpensive ($4) drug
nevirapine given to an HIV-infected woman at the onset of labor and
another to her baby within three days of birth can reduce the
transmission rate by half compared with AZT.
NIAID is spearheading a $144 million initiative to develop new ways
of controlling the human immune system to improve the success of organ
transplants and develop treatments for autoimmune diseases such as
lupus and rheumatoid arthritis.
NIAID-supported investigators created, for the first time, live,
replicating influenza A virus starting with its genetic blueprint. This
research has far-ranging implications for understanding the way flu
strains mutate and spread.
Scientists found that highly active antiretroviral therapy (HAART)
can help adult patients infected with HIV rally and produce new immune
cells.
An NIAID-led effort produced the first high-resolution genetic map
of Plasmodium falciparum, the deadliest malaria parasite.
The genome sequence of Chlamydia trachomatis has been completed.
This bacterium can cause blindness, genital tract infections, infant
pneumonia, and other diseases.
What Could Be Accomplished With Additional Funds
Research into preventing and controlling the global spread of AIDS,
tuberculosis, malaria, influenza, and hepatitis are all in need of
expansion.
Future studies will focus on whole-genome approaches to emerging
pathogen research, including large-scale sequencing, bio-informatics,
and functional genomics.
Mounting evidence suggests that infectious agents may be the
underlying causes of chronic diseases such as coronary artery disease,
diabetes, multiple sclerosis, autism, and chronic lung diseases. New
studies will focus on identifying the infectious agents involved in
these diseases.
Increases in training funds would ensure that a sufficient number
of talented investigators from diverse backgrounds enter immunology and
infectious diseases research.
There are unprecedented opportunities to expand vaccine discovery
and development in a variety of areas within the next five years.
national institute of general medical sciences
The National Institute of General Medical Sciences (NIGMS) supports
basic biomedical research that is not targeted to specific diseases.
Accomplishments
New work explained how one of the B vitamins called folic acid
lowers levels of homocysteine--a risk factor for heart attacks and
strokes--by converting it to a harmless molecule the body needs to fuel
essential chemical reactions.
Scientists discovered structural details of a protein that helps
regulate heart rhythm. The work may shed light on long QT syndrome, a
genetic heart condition.
Scientists gained new insight into how a molecule called a copper
chaperone delivers copper to an enzyme that is defective in some cases
of Lou Gehrig's disease. The work may offer insight into how to block
this delivery in people with the disease.
Test tube experiments revealed an enzyme that may reverse the
damage seen in the brains of people with Alzheimer's disease. The
enzyme untangled ``tau'' protein clumps, which are associated with
memory loss and dementia.
The discovery of molecular signals that prompt embryonic cells to
become liver cells suggests ways to rebuild damaged organs or tissues,
or make new ones from scratch.
Scientists determined the three-dimensional structure of ribosomes,
the cellular factories that manufacture all of the proteins required
for life. Many antibiotic drugs target bacterial ribosomes, so this
work may help scientists in antibiotic development.
Scientists hunted down the molecule that triggers the body's
response to painful heat. The discovery should help researchers find
ways to treat pain.
What Could Be Accomplished With Additional Funds
NIGMS has launched two new initiatives to support pharmacogenetics,
the study of individual differences in drug responses based on genetic
variation.
NIGMS initiated a program to support structural genomics, which
will develop new, faster techniques to determine protein structures
from their gene sequences.
NIGMS has initiated a new program to train the next generation of
scientists to develop computational approaches and associated databases
for biology.
NIGMS supports genomic studies of animals that include mice and
zebrafish.
NIGMS seeks to expand programs to increase the participation of
under-represented minorities in the biomedical sciences.
national institute of child health and human development
National Institute of Child Health and Human Development (NICHD)
fosters research on reproduction, development, and behavior to maintain
the health of children and adults.
Accomplishments
NICHD-funded investigators discovered the gene responsible for Rett
syndrome, a heartbreaking disease that robs healthy infant girls of
their language, mental abilities, and ability to walk.
Children born to mothers with hypothyroidism during pregnancy
scored lower on IQ tests than children born to healthy mothers. When
mothers were treated for the condition, their children scored almost
the same.
For certain types of infertility, induced ovulation combined with
artificial intrauterine insemination is more successful and less
expensive than many other infertility treatments.
Computer imaging of the brain showed that estrogen, commonly
prescribed to treat the symptoms of menopause, may also boost memory in
postmenopausal women.
High doses of vitamin A reduced chronic lung disease in extremely
low birth weight infants.
Researchers discovered that the absence of a protein called CC10 in
premature infants placed the infants at risk for lung disease. Efforts
are underway to manufacture the protein for further testing.
What Could Be Accomplished With Additional Funds
The rate of Sudden Infant Death Syndrome (SIDS) among African
Americans is still more than twice that of whites. NICHD is
intensifying the campaign to stress the importance of placing infants
to sleep on their backs.
NICHD-funded researchers will explore how children learn and how
best to help them when they have learning difficulties. Research
initiatives will also focus on overcoming reading disabilities,
improving mathematics skills, and on how Spanish-speaking children best
learn English.
An NICHD initiative seeks to improve therapies for childhood trauma
victims.
An NICHD initiative will investigate the causes of childhood
violence.
NICHD will launch an array of initiatives focusing on early human
development.
national eye institute
The National Eye Institute (NEI) supports research, training, and
other programs to address diseases of the eye and disorders of vision.
Accomplishments
A new drug called PKC 412 may be important in preventing vision
loss in humans from diabetic retinopathy or macular degeneration.
Scientists detected estrogen receptors in eye tissue from young
women, but not from men or postmenopausal women, that may account for
gender-based differences in some eye diseases and may offer a
therapeutic target for the treatment of dry eye syndromes.
Scientists have recently found that animals with induced detached
retinas experienced less damage when given oxygen treatment. Further
research in this area may lead to a new approach to minimizing retinal
damage in humans with retinal detachment.
Scientists have shown a connection between the molecule nitric
oxide (NO) and damage to retinal nerve cells in the eye. Research is
now being aimed at exploiting this knowledge to develop a new class of
neuroprotective glaucoma drugs.
NEI recently launched studies to determine the extent of eye
disease among Latinos and a clinical trial to determine whether low
intensity laser treatment can prevent the advanced complications of
age-related macular degeneration, the leading cause of severe vision
loss in those over 65.
What Could Be Accomplished With Additional Funds
Nerve cells in the retina can now be purified and grown in the
laboratory. This provides an opportunity to study the mechanisms of
cell survival and injury response.
A number of promising approaches--using growth factors,
transplantation, and molecular and genetic technologies--aim to prevent
or slow down degenerative eye diseases.
Identifying and sequencing genes in the visual system will lead to
a better understanding of the molecular and genetic bases for visual
disorders and diseases, and will ultimately lead to improved treatment
or prevention.
The NEI will continue to fund the Ocular Hypertension Treatment
Study (OHTS), a clinical trial of medications designed to prevent
vision loss from glaucoma. Because glaucoma is the number one cause of
blindness in African Americans, a high percentage of African Americans
are participating in this study.
national institute of environmental health sciences
Accomplishments
NIEHS found that some fatty acids may prevent heart attacks,
strokes: Using mouse models and cultured human cells from the lining of
the arteries, NIEHS-supported scientists have shown that some naturally
occurring fatty acid compounds called epoxyeicosatrienoic acids (EETs)
and their metabolites suppress inflammation, a critical step in the
development of atherosclerosis. This work offers a new therapeutic
approach for preventing the arterial build-up that leads to heart
attacks and strokes.
Liver carcinogen blocked: An NIEHS study in China strongly suggests
that administration of oltipraz would help reduce the risk of
subsequent liver cancers in high risk populations exposed to aflatoxin
and represents an important chemoprevention regimen in the avoidance of
an environmentally-induced cancer.
Learning how cells respond to stress, infection, injury: In times
of stress, such as an infection or injury, the body's cells often
respond with an inflammation. This phenomenon can lead to heart
disease, autoimmunity, asthma, arthritis, neuronal degradation, and
cancer. In a series of cutting-edge studies, NIEHS researchers have
followed the molecular events which occur inside the cell--discovering
molecular targets for potential treatments for these major human
diseases.
What Could Be Accomplished With Additional Funds
The Sister Study Can Clarify Causes of Breast Cancer: NIEHS seeks
to speed a study of the unaffected sisters of breast cancer cases . . .
using questionnaires and a blood and urine samples to clarify the joint
effects of environmental and genetic factors in the etiology of breast
cancer . . . such factors as hormonally active environmental agents,
growth factors, environmental contaminants of general public concern
such as pesticides and solvents, as well as the role of with genes
involved in their metabolic activation. With CDC, NIEHS has developed
the capacity to measure biological markers for 70 new hormonally active
agents, which can be used to analyze the samples.
Children's Environmental Health Centers to Focus on Learning,
Behavior: Following an initial emphasis on asthma and other respiratory
diseases, NIEHS would plan a new phase that will concentrate on two
other key areas in pediatric environmental health: learning and
behavior, and growth and development. New research opportunities
include the investigation of environmental effects on such outcomes as
attention deficit hyperactivity disorder.
Biomarkers for Safety: NIEHS can make important contributions, in
collaboration with the NIH Office of Science Policy and Planning, in
developing biomarkers for drug safety, and thus advancing not only drug
safety but timely drug development.
Comparative Mouse Genomics Center (Expansion of the Environmental
Genome Project): NIEHS would support development of trans-NIH
Comparative Mouse Genomics Centers resource centers that produce
transgenic and knockout mice which will have variants of human
environmental responsive genes found in the general human population,
such as the genes controlling the metabolism of toxicants, for DNA
repair pathways, for the cell cycle control system, for cell death and
for the cell signaling or communication. The Centers' research will be
used by the scientific community to learn the importance of these human
variations, in order to better predict health risks and to develop
environmental policies to protect the most susceptible of us. What is
learned will advance not only the protection of people from
environmental factors but from viruses, nutritional shortcomings, drug
side-effects, and physical and chemical stresses.
Linking Exposure to Human Disease: Using new computer imaging and
computational advances, coupled with sensitive tools of analytic
chemistry and gene expression/function, NIEHS proposes to dramatically
enhance exposure assessment and its use to prevent human disease. In
cooperation with CDC and EPA, NIEHS seeks to address issues of
children's health, of low-dose chemical exposure risks, of environment-
related health disparities, and of gene/environment interactions, as
well as to prioritize chemicals for safety study by the NTP, and
finally, with other agencies, to evaluate of the effectiveness of
regulatory decisions and get the most bang from the buck.
Advanced Research Cooperation in Environmental Health: NIEHS
recently developed a new program called Advanced Research Cooperation
in Environmental Health (ARCH), to link historically black colleges and
universities in research partnerships with research intensive academic
institution--thus expanding the Nation's base of scientists. NIEHS
proposes to expand ARCH to include Hispanic serving institutions and
tribal colleges and thereby establish groups of investigators at these
institutions who can successfully compete for other NIEHS and other NIH
grants.
national institute on aging
The National Institute on Aging (NIA) leads a scientific effort to
uncover the mechanisms of the aging process and to extend the healthy,
active years of life for all Americans.
Accomplishments
NIA has launched a nationwide treatment study to assess the
effectiveness of Vitamin E and donepezil (Aricept) in preventing
Alzheimer's disease. Other clinical studies will look at using
nonsteroidal anti-inflammatory drugs (NSAIDS) to treat Alzheimer's
disease.
Studies of the brain using magnetic resonance imaging (MRI) were
able to predict the development of Alzheimer's disease (AD) within a
three-year period, raising the hope of developing treatments to stop
brain changes before clinical deterioration begins.
Physical activity was found to increase nerve cell growth and
survival in the region of the mouse brain involved in learning and
memory. This study suggests that behavior modification might help
alleviate the age-related decline in brain function.
Transgenic mice without the ability to rebuild telomeres, the
structures at the tips of chromosomes that become progressively shorter
with age, had a shortened life span. When older, they also had an
increased number of spontaneous cancers.
In a long-term study of more than 6500 middle-aged men, low blood
pressure, low blood sugar levels, and avoiding cigarette smoking and
obesity were shown to predict healthy aging. The study also found that
healthy habits or therapeutic interventions can have beneficial health
effects when begun later in life.
What Could Be Accomplished With Additional Funds
Studies will help determine the genetic and environmental factors
that allow centenarians to live to such an old age. Understanding the
genetic, molecular and biochemical basis of aging will help us to
combat aging problems and age-related disease.
NIA will lead the trans-NIH Alzheimer's Disease Prevention
Initiative to make a concerted assault on this disease's development
and progression.
Potential causes of disparities in adult health across race,
gender, and socioeconomic status will be studied in order to reduce
health inequalities.
Carefully designed national studies will examine the prevalence of
elder abuse and the risk factors for elder abuse.
More research is needed into stem cells, which hold enormous
potential for therapy in many degenerative diseases of aging, including
Alzheimer's disease, Parkinson's disease, stroke, myocardial
infarction, mascula-skeletal disorders, immune system dysfunction, and
diabetes.
national institute of arthritis and musculoskeletal and skin diseases
Accomplishments
Improved hormone replacement therapy for older women at risk for
osteoporosis includes lower doses of estrogen and progesterone, in
combination with calcium and vitamin D.
Researchers reported on a transcription factor that is required to
establish the barrier function of the skin. These findings provide
insights into how the skin performs its critical environmental
protective function.
Researchers have successfully used the antibiotic gentamicin to
restore the function of the gene that encodes for the protein
dystrophin in mouse models of Duchenne muscular dystrophy (DMD).
Gene therapy to treat limb girdle muscular dystrophy in animals
made muscles five fold less likely to be damaged during forceful
contractions than untreated muscles.
Optical coherence tomography (OCT) is an advanced new method of
imaging capable of detecting small structural changes in tissues during
the earliest stages of disease.
Researchers found that people who did more than 4 hours of heavy
physical activity per day were 7 times more likely (13 times, if obese)
to develop knee osteoarthritis than people who did no heavy physical
activity. Walking and light physical activities did not increase the
risk.
An international research team showed that the obesity gene leptin,
which helps maintain body weight, also plays a role in controlling bone
density by telling the brain to slow down the rate of bone formation.
This study suggests a new strategy to increase bone density and treat
or prevent osteoporosis.
What Could Be Accomplished With Additional Funds
A public-private partnership is being explored to identify
biomarkers, biological warning signs, for osteoarthritis that would
allow earlier intervention therapies.
A recent workshop identified research opportunities into treatment
approaches for osteogenesis imperfecta, a disease that typically
strikes young children whose bones are very brittle and vulnerable to
many fractures.
NIAMS is planning an initiative with NHLBI to explore promising
research into the roles of vascular calcification and bone cell
regulation in osteoporosis.
Members of the NIAMS intramural research program are designing an
outreach program targeted toward minority communities.
NIAMS is enthusiastically participating in the new NIH K23 and K24
initiatives to stimulate careers in clinical research.
national institute on deafness and other communication disorders
The National Institute on Deafness and Other Communication
Disorders (NIDCD) supports and conducts research into diseases and
disorders of human communication.
Accomplishments
A study of twins and triplets revealed a possible genetic component
to prolonged and recurrent episodes of middle ear infections. Once the
genes are identified, doctors may be able to recognize which children
and siblings are at risk and improve treatment.
An investigational vaccine that targets bacteria causing middle ear
infections was shown to be safe and to provide protection against
infection in animals, which may lead to use in humans.
Scientists have located more than 50 genes that can cause hearing
impairment. Ten have been cloned and the nature of the problems causing
the hearing loss discovered. With the ability to predict who is at
increased risk, better strategies can be developed to minimize or delay
hearing loss.
More than 10,000 children have received cochlear implants, a
prosthesis that converts sound into electrical impulses that can be
interpreted much like sound. Scientists found that children with
cochlear implants had better language skills than children who used
hearing aids.
A large study of children who stutter showed a strong genetic
component to the condition. NIDCD has begun a study to identify the
genes that predispose an individual to stutter.
Dramatic findings this year demonstrated that individual odor
receptors are not dedicated to specific odors. An odor is distinguished
by the unique combination of receptors that respond to it.
What Could Be Accomplished With Additional Funds
NIDCD hopes to identify with precision the early, sensitive periods
for developing speech and language skills.
More research is needed to identify the molecular pathways that may
lead to regeneration of auditory hair cells, a possible strategy for
reversing hearing loss.
A working group will examine studies of the molecular mechanisms of
middle ear infections in the hope of developing novel therapies.
Based on promising recent research advances, NIDCD will
aggressively continue its investigations into the hereditary basis of
hearing impairment.
national institute of mental health
The mission of the National Institute of Mental Health (NIMH) is to
diminish the burden of mental illness through research.
Accomplishments
A White House Conference on Mental Health, the release of the
first-ever Surgeon General's Report on Mental Health and the Surgeon
General's Call to Action on Suicide Prevention this past year were all
made possible by advances in science. There is no longer doubt that
mental illnesses such as schizophrenia, depression, bipolar disorder
and anxiety disorders are disorders of the brain, and that they are
diagnosable and treatable.
The largest and longest study ever of children with attention
deficit hyperactivity disorder (ADHD) found that methylphenidate
(Ritalin) was safe and effective, particularly when coupled with
intensive behavioral treatments.
Scientists showed that primate brains make new cells for the brain
region involved in higher cognitive function. This research gives new
hope for the repair of brain injuries.
NIMH has initiated large-scale clinical trials to learn the best
treatments for bipolar disorder, depression in adolescents, depression
that is unresponsive to initial treatment, schizophrenia, and
Alzheimer's disease.
NIMH research has found that many people have seen their doctors
the month, day, or even hours before they commit suicide, and that many
suffer from depression. This knowledge raises the hope that one day the
majority of these deaths may be prevented.
NIMH research has shown that many risk factors for violence occur
early in a child's life, including child abuse and neglect.
What Could Be Accomplished With Additional Funds
Ongoing clinical trials in neuroscience, behavioral science,
genetics, and clinical investigation will provide solid information
about the best treatments for many mental illnesses including
schizophrenia, depression and bipolar disorder.
Several new clinical trials will focus on children's mental
disorders.
Research on school safety to be initiated this year will improve
our understanding of the social and emotional factors involved in
violent behavior by children.
NIMH is using a broad array of scientific approaches to examine the
patterns of use of psychotropic drugs in young children.
national institute on drug abuse
The National Institute on Drug Abuse (NIDA) conducts and supports
over 85 percent of the world's research on the health aspects of drug
abuse and addiction.
Accomplishments
NIDA launched the National Drug Abuse Treatment Clinical Trials
Network (CTN), which will include not only a wide array of research
centers but also some 250 community-based treatment programs.
NIDA-supported research has demonstrated a potentially powerful new
treatment approach for heroin addiction known as Bup-Nx. FDA approval
is expected soon.
Scientists are finding that abuse of some drugs such as
methamphetamine and MDMA, or ecstasy, can cause long-lasting damage to
the brain.
Using neuroimaging techniques, scientists have discovered that the
amount of dopamine D2 receptors an individual has may predict whether
they will find a drug pleasant.
In animal tests, a new compound, DIPP-NH2 , was found to be three
times more potent at reducing pain than morphine and did not show signs
of physical dependence.
What Could Be Accomplished With Additional Funds
NIDA would increase its research portfolio investigating the link
between drug abuse and various diseases that predominantly affect
minority populations.
NIDA has launched an initiative to understand the role of genetic
and environmental factors in addiction, but it has only been able to
fund half of the excellent proposals received.
Given the increasing use of ``club drugs'' such as ecstasy, GHB,
ketamine, and others, NIDA will increase its efforts to develop
effective new treatments.
Little is known about the short- and long-term effects of chronic
drug abuse on the body. NIDA hopes to increase its efforts to
understand these consequences, especially as drug-using populations
continue to age.
NIDA would launch a Neurobiology of Development Initiative to
determine the effects of drugs on brain development at all ages,
especially those prenatally exposed.
State-of-the-art technologies such as functional magnetic resonance
imaging (fMRI) scanners enable scientists to pose a whole new series of
questions and provide analyses at an even more sophisticated level.
Expanding access to and refining these costly technologies is a high
priority for NIDA.
national center for complementary and alternative medicine
The National Center for Complementary and Alternative Medicine
(NCCAM) is playing a key role in validating unconventional approaches
to health care by supporting rigorous scientific research.
Accomplishments
NCCAM supports the largest, most definitive Phase III clinical
trials ever undertaken for a range of unconventional therapies,
including studies of:
--Ginkgo biloba to prevent dementia (with NIA).
--acupuncture for osteoarthritis pain (with NIAMS).
--glucosamine and chondroitin sulfate for osteoarthritis (with
NIAMS).
--shark cartilage for lung cancer treatment (with NCI).
--saw palmetto extract for enlargement of the prostate (with NIDDK).
--St. John's Wort for treatment of depression (with NIMH).
Five new Specialty Research Center bring the number of research
centers supported by NCCAM to 11. The new centers focus on aging and
women's health, arthritis, craniofacial disorders, neurological
disorders, and cardiovascular disease in African Americans.
What Could Be Accomplished With Additional Funds
The Clinical Research Curriculum Award (CRCA) would support
instruction in complementary and alternative medicine (CAM) clinical
research. NCCAM plans to make awards that help incorporate CAM
information into medical and allied health school curricula.
NCCAM has formed a search committee to recruit a recognized
authority in clinical research to develop an intramural research
program. NCCAM intramural research will be primarily clinical in focus.
NCCAM would like to support studies examining the use of:
--echinacea to treat upper respiratory infections and ear infections.
--massage to speed the development of preterm infants.
--feverfew as a treatment for migraine.
--valerian root for the treatment of insomnia.
--milk thistle extract to treat Hepatitis C and other liver diseases.
NCCAM hopes to support studies of indigenous health systems,
exploring promising traditional therapies for their potential
applicability in the U.S. Examples include Native American medicine and
traditional Chinese medicine.
national institute on alcohol abuse and alcoholism
Approximately 14 million American adults are dependent on alcohol
or abuse it. The direct and indirect costs to the nation are almost
$185 billion annually.
Accomplishments
NIAAA-supported scientists found that the brains of human
alcoholics produced less of a crucial nervous-system protein, myelin,
than those of non-alcoholics. This new finding will help scientists to
pinpoint gene activity that results in damage to alcoholics' brains.
NIAAA's Collaborative Studies on the Genetics of Alcoholism (COGA)
has found the likely chromosomal locations of several genes involved in
alcoholism.
NIAAA-supported studies showed that the new medication nalmefene is
at least as successful in preventing relapse among recovering
alcoholics as naltrexone, the recently FDA-approved drug of choice.
Nalmefene may have advantages over naltrexone, including less liver
toxicity. A Finnish company plans to seek FDA approval.
NIAAA-supported researchers have found that people who drank
heavily during early and middle adolescence score significantly lower
on neuropsychological tests. Heavy drinking in the young may inflict
unique and potentially lasting damage.
What Could Be Accomplished With Additional Funds
NIAAA proposes to establish an Integrative Neuroscience Initiative
on Alcoholism (INIA) that would incorporate the efforts and findings
from various scientific disciplines.
Microarray technology, a recently developed genetics technique,
will give alcohol researchers a clearer picture of the changes in the
brain caused by chronic alcohol exposure and reveal potential
therapeutic targets.
At least nine promising medications for alcoholism treatment await
further testing, but require a faster mechanism for moving from the
laboratory to clinical trial.
NIAAA could conduct the first national, representative sample of
drinking among adolescents and college-age youth. This study is crucial
to estimate treatment needs.
Research is needed to identify the biological, genetic, and
sociocultural factors that contribute to increased risk of fetal
alcohol syndrome in some minority populations.
Recovery rates among alcoholics need to be improved. Clinical
trials that identify biological factors influencing recovery will
enable scientists to work toward this goal.
Researchers could better address the public health threat from
hepatitis C by investigating how alcoholic liver disease and hepatitis
C interact to cause unexpectedly high damage.
national center for research resources
The National Center for Research Resources (NCRR) provides the
critical research tools and infrastructure necessary for scientists to
conduct top-notch health-related research.
Accomplishments
Scientists used powerful high-field nuclear magnetic resonance
(NMR) spectrometers to identify the crucial parts of the prion protein
that can change and cause degenerative brain conditions such as mad cow
disease, scrapie in sheep and goats, and Creutzfeldt-Jakob disease and
kuru in humans.
Postmenopausal women with hip fracture were found to show signs of
vitamin D deficiency, which can be prevented with proper nutrition and
vitamin supplements.
Researchers uncovered the three-dimensional structure of the cell's
tiny protein factories known as ribosomes in unprecedented detail using
high-energy x-rays.
Scientists have found that most babies with severe combined
immunodeficiency (SCID), a rare and sometimes fatal syndrome marked by
a lack of immune system cells, can survive if given a bone marrow
transplant from a family member within 14 weeks of birth.
By evaluating monkeys with a specially made contact lens over one
eye, scientists discovered that visual development in one eye could be
significantly altered by modifying vision in the other. These findings
may point to new avenues for treating and preventing visual problems in
infants and young children.
What Could Be Accomplished With Additional Funds
Improved imaging systems are needed to investigate the cause,
progression and treatment of brain pathologies.
NCRR proposes to establish informatics centers that will facilitate
research in areas such as genomics that generate very large data sets
requiring high-end computation.
NCRR proposes to establish state-of-the-art resource centers for
analyzing gene expression, which will in turn facilitate defining gene
function.
NCRR proposes to increase support for synchrotron facilities, which
produce the world's most brilliant x-rays and are crucial to structural
biology and drug design studies.
NCRR proposes to help alleviate health disparities among racial and
ethnic minorities by establishing several Comprehensive Centers on
Health Disparities at minority medical schools. The centers will focus
on cancer screening and management, cardiovascular disease, and stroke.
national institute of nursing research
The National Institute of Nursing Research (NINR) supports clinical
and basic research to establish a scientific basis for the care of
individuals.
Accomplishments
The transitional care model, with follow-up in the home by advanced
practice nurses, was shown to improve the health of older adults with
common medical and surgical problems at a 48 percent savings to the
healthcare system. Widespread use of this model could improve the
quality of patient care and save significant healthcare dollars.
NINR has tested the effectiveness of a 6-week arthritis self-
management course in Spanish to help Hispanics control this widespread,
painful condition. Four months after the course was completed,
participants showed notable improvements in their arthritis and better
overall health.
Very low birthweight infants require procedures that are probably
painful to them. To avoid the use of drugs and their possible side
effects, investigators tested three non-medication interventions in an
effort to ease pain in these tiny babies. Pacifiers with sucrose or
sterile water were found to significantly reduce pain.
Researchers have found that a carefully designed educational
program for teens who select to use the insulin infusion pump rather
than multiple insulin injections enables them to achieve excellent
control of their diabetes.
What Could Be Accomplished With Additional Funds
More funds would allow an intensive focus on research for improving
end-of-life symptom management of pain, nausea, and weight loss.
Increased resources would focus on helping minorities, who have a
high rate of diabetes, manage their condition effectively.
A new initiative would support in-depth research on promising self-
management strategies for patients with such chronic illnesses as
diabetes, arthritis, and congestive heart failure.
Research would be undertaken to investigate the effectiveness of a
wide range of telehealth interventions, especially in rural and other
underserved areas.
NINR would support multidisciplinary clinical trials to improve
adherence to treatment, help patients make decisions about therapy, and
manage the symptoms of chronic illness.
NINR would broaden the training opportunities for nurse researchers
in the field of genetics, including an expansion of the new Summer
Genetics Institute.
national human genome research institute
The National Human Genome Research Institute (NHGRI) aims to
characterize the genomes of human and selected model organisms through
complete mapping and sequencing of their DNA.
Accomplishments
Human Genome Project scientists have deciphered 2.25 billion of the
3 billion chemical units of human DNA. Planners expect to complete a
working draft of 90 percent of the genome by this spring and to finish
the human sequence by 2003.
NHGRI-supported scientists deciphered an entire human chromosome,
Chromosome 22, for the first time.
The public database GenBank has accumulated over 3.8 billion base
pairs of DNA sequence. Scientists find this information invaluable--
there are approximately 5 million searches of the GenBank data daily.
What Could Be Accomplished With Additional Funds
The roles of human genes are often discovered by comparing their
DNA sequences to that of other organisms. Publication of the complete
sequence of the fruit fly Drosophila melanogaster is expected in early
2000. Having the genome sequences of other organisms will be critical
for improving the speed and accuracy of understanding gene function and
disease.
A catalogue of the places in the genome where the DNA sequence
differs among individuals will help in the effort to discern the
genetic factors associated with many common diseases. Alterations in
our genes are responsible for an estimated 3,000 to 4,000 hereditary
diseases, including Huntington's disease, cystic fibrosis, and
polycystic kidney disease. Genetic factors also interact with lifestyle
and environmental factors like diet and cigarette smoking to influence
the development of many common illnesses. In the future, an individual
might be screened for hereditary predispositions to diseases and
counseled on steps to prevent these diseases or delay their onset.
Supporting the fundamental research needed to develop new
sequencing technology will continue to be important, even after the
reference human genome sequence is finished. Faster and cheaper
sequencing machines are vital to the identification of sequence
variations associated with disease, to understanding gene function, and
to the incorporation of new genetic technologies into patient care.
In the future, an individual may be able to take a credit card size
DNA ``chip'' containing his or her personal DNA profile, along with a
drug prescription, to a pharmacy, where the medication will be tailored
to the individual's genes. The result will be fewer side effects and
more effective treatment.
fogarty international center
The Fogarty International Center (FIC) supports research and
research training to address global health challenges.
Accomplishments
Fogarty collaborators in Uganda have helped show that single doses
of the anti-retroviral drug nevirapine prevent mother-to-infant
transmission of HIV, and are more effective and much cheaper than AZT.
FIC-supported researchers have developed a new technique to more
easily identify the virus that causes dengue fever, a reemerging
infectious disease in the developing world.
FIC has developed a collaborative program to combat tuberculosis
(TB) with NIAID, CDC and USAID. Early results show progress with two
drugs: prednisone and isoniazid.
An FIC-supported health survey shows that people exposed to
unprocessed cooking fuels in their homes are at a substantially
increased risk of having active tuberculosis.
FIC supports an International Training in Medical Informatics
Program to train people from the developing world to apply state-of-
the-art information and communication technologies to research and
health surveillance activities.
What Could Be Accomplished With Additional Funds
FIC would establish an international research and training program
to address tobacco prevention and control as well as research capacity
in developing countries.
FIC would develop a cadre of mental health experts in low- and
middle-income nations by promoting programs to provide researchers with
relevant scientific training.
Efforts would be devoted to train scientists in molecular biology
and molecular epidemiology techniques of relevance to developing
countries.
FIC would expand its clinical research and training programs to
support professionals from developing nations. Clinical trials of drugs
and vaccines of mutual benefit to the United States and host countries
will form a major part of this activity.
FIC would establish a program designed to reduce malnutrition and
to support research to prevent and treat diseases through nutritional
intervention.
FIC would establish a program designed to strengthen epidemiology
research and clinical trials capacity to evaluate candidate vaccines
for parasitic, bacterial, and viral disease in low- and middle-income
nations.
national library of medicine
The National Library of Medicine (NLM), the world's largest medical
library, uses computer and communication technologies to improve the
organization and use of biomedical information.
Accomplishments
ClinicalTrials.gov, a new database developed by NLM, has just been
made public. It is an easy-to-use system that provides the public with
information on more than 4,000 federal and private scientific studies
involving human subjects.
MEDLINEplus, the Web-based consumer-oriented health information
service, is now delivering more than a million documents each month.
The service links users to extensive data about 350 diseases and
conditions, and most recently to the NIH ClinicalTrials.gov database.
NLM made awards to fund 49 electronic health information
``outreach'' projects in 34 states that will increase Internet access
in a variety of community-based settings.
Another new information resource developed by NLM is ``PubMed
Central,'' the just-released Web-based repository that provides
barrier-free access to primary reports in the life sciences.
What Could Be Accomplished With Additional Funds
ClinicalTrials.gov plans to expand to include studies not funded by
the Federal Government. With additional support, PubMed Central
eventually will contain peer-reviewed reports from journals and reports
that have been screened but not formally peer reviewed.
NLM is planning to provide access to extensive information about
prescription drugs as the next major improvement to MEDLINEplus.
Additional resources would be needed to expand the current outreach
campaign through public libraries and other community organizations.
Additional support will allow NLM to augment the medical
informatics training programs at its 12 centers and to make training
awards to new institutions.
NLM is supporting the development of the Next Generation Internet.
Additional funds will support a projected Phase III.
NLM's National Center for Biotechnology Information (NCBI)
collects, analyzes, and distributes molecular biology data related to
genomic analysis. NCBI manages the GenBank database. These
sophisticated information tools and resources must be improved,
expanded, and made even more widely available.
Senator Specter. We have given you a fair amount of work to
do, but we are going to have a lot of work to do on this end in
trying to get this funding.
This will be the third round and I think our concluding
round. I will call now for the final question.
Senator Feinstein.
Budget Increases
Senator Feinstein. Thanks very much, Mr. Chairman.
I was wondering if you could tell me how the various
institutes apply an increase in budget across the board. And
what I mean by this, in the past 2 years, there has been a 15-
percent increase. But apparently these increases are not
applied equally across the board, for example, in lupus or
diabetes. Could you tell me how this figure gets applied across
the board, or if it does?
Dr. Kirschstein. It gets applied based on a number of
factors that the institute directors use to make decisions.
Each institute has a mission statement and has developed a
strategic plan to relate to all the diseases, dysfunctions,
organ systems that are under the purview of that institute.
In addition, the institutes seek advice very, very broadly
from the statutorily mandated advisory councils, as well as
other review groups of experts in the various fields. And over
that large assemblage of advice and over a period of time and
in discussion with their colleagues and with the Director of
NIH, Dr. Varmus over the past years, final decisions are made
as to what might be possible to do in a particular field.
Certain scientific areas, certain diseases are more ready
for a great expansion in funds to move them forward than are
others. Others need nurturing in a different way, small
workshops or large conferences, to prepare the field to be able
to do more research. And then the institutes make decisions as
to what types of allocations go to each area.
The decisions also include how burdensome the disease can
be, the quality of life with the disease, whether it affects
one population, a majority population, a minority population,
whether it affects women versus men. And all those factors are
taken into consideration along with the scientific judgments of
all these outstanding directors, to make the final decisions.
And I would offer my colleagues, any one who might wish to,
to add to the answer.
Senator Feinstein. Could I just follow up on that? Are you
saying effectively that money goes based on how ready the
science community is to advance the ball up the field, or are
you saying the money goes based on the presence of viable
projects? Your answer was unclear in this area.
Dr. Kirschstein. The answer is that it is both, and many
other factors, as well. There is not one way, I do not think,
that any institute or any entity decides, ``I shall spend,'' or
``We shall spend' X' amount on a particular disease.''
It is indeed projects that are ongoing that can be expanded
because new developments have occurred. There may be an
emergency situation.
Recently, for example, over the last several years, as
tuberculosis reemerged as a disease that had not been of as
much significance in the previous years, it was felt that it
was an emergency of such a nature that a considerable amount of
money had to be put into it.
So there are varying reasons to do this. And each institute
director uses the best expertise from the community, from
outstanding scientists, from the advisory and advocacy groups,
and then comes to the best decisions possible.
Senator Feinstein. Thank you very much, Doctor.
Senator Specter. Thank you very much, Senator Feinstein.
Well, we very much appreciate you all coming in today. As I
have said in the past, we are reluctant to interrupt your
research to have you come to these hearings, but it is a very
impressive group. And we will be working hard to provide the
funding which will enable you to continue to serve America and
the world.
Cancer Group Letters
That concludes the hearing.
Senator Feinstein. Mr. Chairman, before you adjourn, I have
some letters from major cancer groups that deserve a response.
May I ask that they be submitted for response?
Senator Specter. They will be made a part of the record for
response.
Senator Feinstein. Thank you very much.
[The information follows:]
Letter From Marin Breast Cancer Watch
Marin Breast Cancer Watch,
San Rafael, CA, February 22, 2000.
Dear Senator Feinstein: I am very appreciative of your continuing
efforts on behalf of the breast cancer stamp. As I told you in our
phone conversation, we love the stamp and feel it has helped heighten
awareness of the epidemic. However, we do want to know exactly where
the money is going, and if it is not going into researching the causes,
we would like to know why not.
Donna Shalala said in her letter to you that the Insight Awards
program received 400 applications, with 20 percent related to
environmental causes of breast cancer. How much money would it cost to
fund all 80 applications related to environmental causes?
We would also like to know who is on the panel of scientists and
who are the patient/advocate representatives? Who is on the
presidentially appointed National Cancer Advisory Board? How can we
influence the awards decision? To whom can Marin Breast Cancer Watch
members write? Call? E-mail?
Shalala's letter says ``Environmental factors have long been
suspected as playing a causal role in breast cancer, and both NCI and
the National Institute of Environmental Health Sciences already support
many studies specifically addressing the role of the environment in
breast cancer.'' We are unaware of these studies. How can we get more
information on them?
I, personally, am delighted to have you as an ally in this struggle
to stop the epidemic of breast cancer. I believe, with all of us
working together it will happen.
Sincerely,
Fracine Levien,
Founder/Executive Director.
______
Letter From The Breast Caner Fund
The Breast Cancer Fund,
San Francisco, CA, March 7, 2000.
Re Request to redirect Breast Cancer Stamp Funds to NIEHS.
Senator Dianne Feinstein,
Washington, DC.
Attn: Glenda Booth
Dear Senator Feinstein: As you know, The Breast Cancer Fund (TBCF)
is very concerned about the dearth of funding for research that
investigates linkages between environmental factors and breast cancer.
I am therefore writing to request that you consider redirecting the
funds raised by the Breast Cancer Stamp to the NIEHS in the re-
authorization bill scheduled for this summer.
In Secretary Donna Shalala's letter to you dated February 14, 2000,
she stated that of the 400 grant applications for breast cancer stamp
revenues, 20 percent are related to environmental causes of breast
cancer, ``an area of major concern to many breast cancer advocates.''
The 20 percent number is low and most likely will result in less than
20 percent of the awards. However, an even greater problem exists with
the definition of environmental factors.
Advocates use environmental research to mean studies about the
effect of chemicals and radiation on the development of breast cancer,
while Federal agencies like the NCI include in the concept diet,
exercise, genetics, alcohol use, pharmaceuticals and hormones, as well
as chemicals and radiation. With this expanded definition, NCI always
appears to be doing more than it actually is with regard to research
into the effect of environmental toxins, including pesticides,
industrial chemicals and pollutants, and radiation.
TBCF has done extensive oversight to determine how much funding
from two other important allocations for ``environmental research''
actually went to studies into the connections between breast cancer and
environmental toxins. We report as follows:
(1) 1997 emergency supplemental budget
The first incident occurred in 1997, in the Emergency Supplemental
Budget to which Representative Nancy Pelosi added a $15 million
appropriation to study breast cancer and environmental toxins in areas
of high breast cancer incidence. TBCF worked closely with Congresswoman
Pelosi to draft the appropriation language and waited patiently to
learn about the allocation of these funds. No action or reporting from
the NIH was forthcoming, until, finally, in 1998, TBCF filed a Freedom
of Information Act (FOIA) to find out whether all the groups named in
the legislation were consulted and what the disposition of the funding
was.
TBCF has compiled a chronology of events that the FOIA disclosed,
which we are enclosing with this letter. As you will see, first, $3
million was allocated for air pollution research, and the remaining $12
million appears to have ended up in three RFAs. However, it is
difficult to determine exactly what funds were related to the original
appropriation, as the addition of all funding amounted to $8.25 million
out of the original $12 million allocation.
As a follow-up, Representative Pelosi wrote a letter Dr. Harold
Varmus at the NIH (12/99) requesting clarification on the RFAs and
their relationship to the study of environmental toxins and breast
cancer risk factors in the high incidence areas enumerated in the
legislation. No reply has come as yet.
(2) nci extramural research on breast cancer and environmental factors
For several years, TBCF and other advocates wrote to Dr. Varmus
requesting that the NIEHS budget be doubled since the mandate of that
agency is to investigate the connections between environmental factors
and disease. In the initial correspondence with Dr. Varmus, we were
told that there were 40 extramural projects in 1997-98 that related to
``Breast Cancer and the Environment.'' Once again, our analysis reveals
that Dr. Varmus and the NCI were including topics like exercise and
diet in their interpretation of ``environment.''
Of the 40 cited projects, TBCF looked for those related to
environmental chemicals, radiation and EMFs. Our use of the term
``environmental factors'' was done in the most generous way. For
example, we included as environmental research the creation of the New
York Cancer Registry which is necessary for any future study of
environmental factors. With numbers rounded to the nearest thousand,
our analysis revealed the following results:
Total funding for all projects: $11,967,000
Total environmental projects: 12
Total funding for environmental projects: $4,228,000 or 35
percent of total funding.
It should also be noted that the funding for environmental research
cited by Dr. Varmus represents a pittance of the total NIH budget of
$15.6 billion and that the NIEHS budget was $382 million or 2.4 percent
of the NIH budget for the period in question.
As a next step, TBCF plans to obtain a detailed description of
total intramural breast cancer research funding at NCI for the 1997-98
period to determine what percentage of those funds went to research on
breast cancer and environmental factors, as we define them. We hope you
will consider the two incidents described above as you consider whether
we will actually get research into the environmental causes of breast
cancer by allowing the NCI to continue using the Breast Cancer Stamp
funds as described by Secretary Shalala.
As you know, The Breast Cancer Fund has been and will continue to
be a major supporter of the Breast Cancer Stamp. Not only is the
funding raised by the stamp vital, but it gives the public a welcome
opportunity to contribute to much needed research into a disease about
which we are all concerned. We believe that the stamp revenues can have
an even greater impact, however, if they are specifically directed to
research into the causes of the disease. Identifying environmental
toxins that are contributing to the disease and that can be reduced or
eliminated would give us the first step toward real prevention.
Thank you for considering this request, and please do not hesitate
to contact us if we may be of further assistance in this matter.
Sincerely,
Andrea R. Martin,
Founder and Executive Director.
Enclosure.
Chronology of Freedom of Information Act (FOIA) Request Regarding $15
Million Emergency Appropriation for Breast Cancer and Environmental
Factors Research
(By the Breast Cancer Fund)
Congresswoman Nancy Pelosi inserted a section in the FY 1997
Emergency Supplemental Budget that called for a special $15 million
appropriation, as follows:
``. . . for the purpose of supporting multicenter research studies
on environmental risk factors associated with breast cancer and factors
related to regional variations in breast cancer incidence and
mortality. The Committee understands that there may be a significant
link between toxics and other chemical substances present in the
environment and the high rate of breast cancer among women in certain
areas of the country.''
Several States were listed, including California, where high breast
cancer incidence and mortality has been recorded. In line 12, Chapter
7, language was included mandating ``consultation'' with other agencies
in the distribution of the funds:
``These funds will be made available on a competitive basis and
through mechanisms determined by the Secretary, in consultation with
the Directors of the National Institutes of Health, the National Cancer
Institute, the National Institute of Environmental Health Sciences, the
Centers for Disease Control and Prevention, and the Deputy Assistant
Secretary for Women's Health.''
The Breast Cancer Fund (TBCF) has a copy of a letter from Secretary
Shalala to Senator Tom Harkin (12/19/97) which explained that the
Emergency Supplemental Budget bill had passed and of the $15 million
appropriated, $3 million was to be spent on air pollution studies that
related to cancer and respiratory diseases. This proposal was puzzling
since the funds were slated for breast cancer studies.
One year after this emergency budget bill was law (Public Law 105-
18), no information or requests for proposals had come forth from the
National Institute of Health. TBCF has taken the following steps to
determine the disposition of the $12 million and which agencies.were
consulted in the disposition.
10/14/98.--TBCF sent a FOIA to the Department of Health and Human
Services (DHHS) Secretary Shalala requesting written proof that all the
groups listed in the consultation mandate had been involved.
10/21/98.--A postcard was received by TBCF from the DHHS with a
note that consideration of our request was underway and that all future
contact should refer to case number 99-54W.
10/29/98.--A postcard was also received by TBCF from the Centers
for Disease Control and Prevention (CDC) that consideration of our
request was underway and in the future to refer to case number 99-151.
01/21/98.--Rosario Cirrincione from the DHHS Office of Public
Affairs, on behalf of the Executive Secretariat, sent 62 pages of
records to TBCF in response to our FOIA request.
03/31/98.--Ioana Petrou, Esq., TBCF General Counsel and Board
member sent Rosario Cirrincione a letter indicating that none of the 62
pages related to the disposition of the $12 million in Public Law 105-
18. The request for appropriate records was repeated.
06/28/99.--A letter was sent to TBCF from Beatriz Flores, FOI Clerk
at the Public Health Service of DHHS, accompanied by a half inch of
documentation \1\ which answered our consultation questions and some
issues about how the requests for research proposals were drafted. The
Flores cover letter stated clearly that CDC had no records regarding
this appropriation, which means CDC was not consulted. No evidence was
submitted that the Office of Women's Health was consulted either. The
additional documentation concerned the specifies of the Request for
Proposal Applications (RFA) as follows:
---------------------------------------------------------------------------
\1\ Document Summary: The $12 million allocation was spread over a
four-year period which would have resulted in a maximum of $3 million
per year. However, $0.5 million of these funds was taken away to do
occupational research and another $0.25 million was applied to some
risk exposure work, neither of which allocations appears to relate
directly to breast cancer and environmental toxins. In addition, funds
were allocated to the NCI/NIEHS ``Exposure Assessment in Cancer
Epidemiology'' amounting to $2.5 million a year for 3 years. The total
funds to be awarded amounts to $8.25 million out of a $12 million
allocation.
---------------------------------------------------------------------------
(1) Regional Variation in Breast Cancer Rates in the U.S. RFA: CA-
98-017 Application Receipt Date: 8/25/98
(2) Interdisciplinary Studies in the Genetic Epidemiology of Cancer
RFA: CA-98-018 Application Receipt Date: 11/17/98
(3) Implementation of the National Occupational Research Agenda
RFA: OH-99-002 Application Receipt Date: 6/10/99
______
Letter From Breast Cancer Action
Breast Cancer Action,
San Francisco, CA, March 10, 2000.
Re Breast Cancer Stamp Re-authorization.
Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
Dear Senator Feinstein: We write on behalf of the undersigned
organizations and the thousands of people we represent to urge you to
consider changing the language of the bill to re-authorize the breast
cancer stamp.
While we think this is a creative and important program, we
strongly believe that the funds generated need to be spent in a way
that might make a significant difference in the breast cancer epidemic.
That will not happen if the current structure of the stamp program is
maintained. The 70 percent of stamp proceeds that are allocated to the
National Institutes of Health (NIH) should be directed by law to the
National Institute of Environmental Health Sciences (NIEHS). Leaving
the allocation of funds to the discretion of the NIH means more of the
same kind of research that has done little to uncover the causes of
breast cancer.
We know that you share our concern about how the portion of the
stamp funds that are directed to the National Institutes of Health are
spent. Your office has shared with us the letter dated February 14 in
which Secretary Shalala responds to your questions regarding
expenditure of the funds. That letter reveals precisely why it is
important to change the structure of the stamp program. Secretary
Shalala states that the stamp funds have been allocated by the NIH to
the National Cancer Institute (NCI), which, in turn, has created a new
awards program for the funds. The letter states that, of the 400 grant
applications received, twenty percent relate to environmental causes of
breast cancer. Notably, the letter does not indicate how many of those
grants the NCI expects to fund. And, based on the NCI report,
``Charting the Course: Priorities for Breast Cancer Research,'' which
is the impetus for the grant program, it is unlikely that many of those
applications will be funded.
However, an even greater problem is the definition of
``environmental factors.'' When advocates use this phrase. they mean
chemicals and radiation, while the NIH and NCI mean diet, exercise,
alcohol use, hormones, as well as chemicals and radiation. By using
this expanded definition, the NCI always appears to be doing more than
it actually does with regard to research on ``the environment'' and
cancer.
As even a brief review of the ``Charting the Course'' report
reveals, the NCI continues to focus its attention primarily on the
molecular biology of breast cancer and on so-called ``chemoprevention''
strategies. The work being done to identify what in the environment
might be causing the increased incidence of breast and other cancers is
not being done at the NCI. If that work is being done at NIH, it is
being done at the NIEHS.
As you know, the funds generated by the stamp are small in the
scheme of what is directed toward and needed to solve the breast cancer
problem. In light of that, it is all the more important to make sure
that the funds are spent in a way that at least has a chance of
addressing some aspect of true prevention. If we are ever to truly
solve the problem of breast cancer by preventing the disease, we will
need to discover and eradicate the causes of the disease.
We look forward to working with you to make the breast cancer stamp
program as effective as it can possibly be, and we believe that this
will occur by making the NIEHS the designated recipient of the stamp
funds allocated to the NIH. We also believe that the stamp will gain
even more popular support when the public is made aware that the funds
will be directed into research on possible preventable causes of the
disease.
Thank you for attention to these concerns, and for all you do to
address the concerns of the growing population of people touched by
breast cancer.
Sincerely,
Barbara A. Brenner, Executive Director, Breast
Cancer Action, and on behalf of Francine
Levien, Executive Director, Marin Breast
Cancer Watch; Catherine Porter, Esq., Legal
Services and Public Policy Coordinator,
Women's Cancer Resource Center; Andrea R.
Martin, Founder and Executive Director, The
Breast Cancer Fund; Sharon Batt, Breast
Cancer Action Montreal; Nora Cody, DES
Action; Judy Norsigian, Boston Women's
Health Book Collective.
______
cancer group letter
The importance of lifestyle and other environmental exposures as
contributing factors of cancer is unquestionable. The pivotal role of
the environment is reflected in the substantial variation in cancer
incidence around the world. Furthermore, epidemiologic research has
succeeded in identifying a wide range of cancer-causing exposures,
including tobacco use, dietary components, sunlight, ionizing
radiation, environmental chemicals, infectious agents, obesity,
exercise, hormones, and reproductive factors. Indeed, the largest
source of variability in cancer risk is due to behavior. Nevertheless,
the causes of many cancers remain elusive. While better approaches to
measuring exposures will provide new insights, it is clear that the
environment represents only part of the equation in determining who
will get cancer.
NCI, as the Nation's leading institute in supporting and conducting
cancer research, has placed a special focus on breast cancer research.
NCI has a portfolio of over 1400 individual NCI-funded projects having
relevance to breast cancer. In fiscal year 1999, NCI expended over $387
million in research related to breast cancer, and for fiscal years 2000
and 2001, this figure is expected to be about $425 million and $450
million respectively.
To support the full range of research activities necessary to
conquer cancer, including breast cancer, NCI uses a complex and dynamic
process to set our scientific and funding priorities. This process is
driven by several principles:
--Strive for a balanced portfolio of research in behavior,
epidemiology, control, etiology, prevention, detection,
diagnosis, treatment, survivorship, rehabilitation, and end of
life issues;
--Link all pieces of the cancer research enterprise through
translational research;
--Rely on our diverse constituencies--including scientific, medical,
advocacy and other public communities--to help us identify new
opportunities, gaps, and barriers to progress, create new
programs, and improve existing ones.
From a strategic level, we integrate priority setting into all of
our strategic planning activities. For breast cancer research planning,
NCI established a Progress Review Group (PRG) in 1997 to assess the
status of breast cancer research and to provide recommendations on
direction and priority to speed the progress. The Breast Cancer PRG was
composed of prominent members of the scientific, medical and advocacy
communities and their report, published in August 1998 and entitled,
``Charting the Course: Priorities for Breast Cancer Research,'' is the
framework NCI uses to support a balanced portfolio of breast cancer
research (http://wwwosp.nci.nih.gov/planning/prg/
bprgtableofcontents.htm).
From the research application level, we integrate priority setting
into the funding of individual research applications based on
scientific merit. NCI, like the rest of NIH, uses scientific peer
review panels to competitively determine the technical validity,
soundness and ranking of the individual grant applications. However,
NCI has increasingly used lay reviewers/consumer advocates in our
scientific review panels to provide a consumer perspective. These
consumer advocates actively participate in discussions, present the
patient perspective, and vote on the applications. During the last 18
months, consumers have participated in almost 60 reviews, including the
panel currently reviewing the applications for the program announcement
``Insight Awards To Stamp Out Breast Cancer,'' the program that will
use the funds contributed by consumers in support of the 1997 Stamp Out
Breast Cancer Act.
The Insight Awards are a new initiative designed to support
innovative pilot studies that are likely to generate new understanding
about breast cancer and to advance underdeveloped areas of research as
identified by the Breast Cancer PRG's 1998 report. The focus of this
initiative is to support innovative high risk/high payoff research that
would not be funded under normal circumstances. Over 400 applications
have been received and are being competitively reviewed by a peer
review panel for the available funds. The role of the peer review
process is to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of the initiative's goals. The
applications are being judged solely on the basis of scientific merit,
with attention given to a balanced research portfolio as articulated in
the Breast Cancer PRG's report. To preserve the integrity of the peer
review process, names of individuals participating on review panels
must remain confidential until the selection of awardees is made.
Finally, in regard to the question on the status of the breast
cancer research funds provided by the 1997 Emergency Supplemental
Appropriations Act (Public Law 105-18), I am submitting a letter sent
to The Honorable Nancy Pelosi, dated 15 March 2000, along with the
enclosures that describe the disposition of the funds and the vital
research it is supporting.
______
Letter From Dr. Richard D. Klausner
Department of Health & Human Services,
National Institutes of Health, National Cancer Institute,
Bethesda, MD, March 15, 2000.
Hon. Nancy Pelosi,
House of Representatives,
Washington, DC.
Dear Ms. Pelosi: Thank you for your letter of December 2, 1999, to
the Director of the National Institutes of Health. It has been
forwarded to the National Cancer Institute (NCI) for reply. Your letter
addressed the disposition of the funds designated for the Department of
Health and Human Services (DHHS) Office of the Secretary, and
subsequently to the NCI, in the 1997 Emergency Supplemental
Appropriations Act (Public Law 105-18, enclosed). I appreciate this
opportunity to provide for you descriptions of our activities relating
to this appropriation and the vital research it is supporting.
The language contained in the Act directed the Secretary to use the
funds appropriated ``For expenses necessary to support high-priority
health research'' and the Conference Report (105-119, enclosed), which
superseded the original Senate Report, provided the further direction
that the Secretary consult with the Directors of the National
Institutes of Health (NIH) and the Centers for Disease Control and
Prevention (CDC), and the Deputy Assistant Secretary for Women's Health
to determine the most appropriate mechanisms for distribution of the
funds. The conferees stipulated that the funds should be competitively
awarded and further requested that the Secretary consider dedicating
the funds to cancer research, ``especially research investigating the
environmental factors that may be associated with breast cancer in
communities with high incidence of the disease,'' and asked for a
report on the Secretary's plan for allocating the funds.
After designing a strategy to invest in the best opportunities for
advancement, several initiatives were identified that reflected the
vision of the conferees about the disposition of these funds. Dr.
Harold Varmus, Director of the National Institutes of Health (NIH) sent
a report (enclosed) to Congress describing the plan. The appropriation
was divided into two parts: NCI is coordinating the disposition of $12
million allotted for the study of the role of environmental factors in
cancer; and National Heart, Lung, and Blood Institute (NHLBI) is
coordinating the disposition of $3 million for the study of health
effects of air pollution. Air pollution studies were included in the
research package at the request of the Secretary of the Department of
Health and Human Services in response to the President's call for more
research on the health effects of air pollution exposure as part of his
implementation plan for the Environmental Protection Agency's (EPA)
revised regulation on air quality standards. To date two projects have
been identified for funding.
To administer the cancer research portion of the funds, the NCI, in
collaboration with National Institute of Environmental Health Sciences
(NIEHS), National Institute on Aging (NIA), National Institute for
Occupational Safety and Health (NIOSH) at CDC and the National Center
for Environmental Research and Quality Assurance at EPA, prepared and
issued Requests for Application (RFA) to solicit proposals from
interested investigators. Proposals were reviewed and selected for
funding based on a rigorous evaluation of scientific merit. This peer
review process is arduous, but necessary to ensure that money the
Congress and the American people have entrusted to us is used wisely.
The initiatives envisioned in the plan and their subsequent
implementation, including the funding allotted to each project, are
outlined in Table 1 (enclosed).
The RFA entitled ``Regional Variation in Breast Cancer Rates in the
United States'' launched 5 new projects in which investigative teams
are using statistical and epidemiologic methods to investigate factors
that may influence, contribute to, or account for the reported
differences in breast cancer incidence and mortality rates across
different geographic regions. Data on women residing in California,
Connecticut, Georgia, Hawaii, Iowa, Massachusetts, Michigan, New
Mexico, Washington, Wisconsin, and Utah will be analyzed. An additional
award supplemented an ongoing study in New York that is evaluating the
effect of electromagnetic field radiation (EMF) on breast cancer risk.
Five new grants were awarded under the RFA entitled
``Interdisciplinary Studies in the Genetic Epidemiology of Cancer''.
These projects, operated together as a consortium with three related
NCI-funded projects, will be working to understand the way genes
interact with environmental factors in cancer development. Although
only one of these projects addresses breast cancer specifically, each
of them promises to contribute knowledge about the impact of the
relationship between genetic and environmental elements in cancer
incidence and survival, an extremely important area of cancer research.
Since research on environmental exposures alone cannot bring us all the
information we need, we must also address the synergistic effects of
genes and environmental factors to understand how a normal cell becomes
cancerous.
In response to the RFAs entitled ``Implementation of the National
Occupational Research Agenda'' and ``Mechanistic-Based Cancer Risk
Assessment Methods'' four new grants were awarded to develop and/or
improve methods for assessing past environmental and occupational
exposures that could be associated with geographic patterns for some
cancers including breast cancer. Research of this type (called exposure
assessment) is important in understanding breast cancer for two
reasons: First, we must be able to link breast cancer development to a
carcinogen exposure that occurred years before the diagnosis; and
second, we must be able to obtain environmental data for assessing the
role of gene-environment interactions in the etiology of breast cancer.
In May 1999, NCI awarded a $4.87 million 5-year contract ($2
million from the fiscal year 1997 supplemental funds) to develop and
implement the prototype geographic information system for health (GIS-
H) for breast cancer studies on Long Island. The GIS-H, the first of
its type, will provide a new tool for researchers to investigate
relationships between breast cancer and the environment, and to
estimate exposures to environmental contamination. The GIS-H data
layers will include geographic data for general mapping purposes and
demographic data. Data on health care facilities, health care surveys,
breast cancer, and the environment will also be included. The
environmental data will include information on contaminated drinking
water, sources of indoor and ambient air pollution, including emissions
from aircraft; EMFs; pesticides and other toxic chemicals; hazardous
and municipal waste; and radiation. The system will rely chiefly on
existing databases obtained from Federal, State, and local governments,
as well as private sources, with emphasis placed on high-quality data.
It is expected to be available for pilot studies in mid-2001. A Web
site is available where the public and researchers can follow the GIS-
H's progress and obtain summary information about the databases: http:/
/www.healthgisli.com.
The important work supported by the Public Law 105-18 funds is part
of our continuing commitment to a broad research agenda that promotes
discovery of the ways that environmental exposures to carcinogens lead
to the development of cancer. A new RFA will be issued this year to
direct the remaining funds toward promising studies of this nature (see
Table 1) and NCI sponsors many other projects in this research area. In
accordance with our own strategic plan and the intentions of the
conferees, the funds are being used to capitalize on scientific
opportunities that continue to provide significant new information and
that will advance our knowledge of cancer processes.
I hope this information is useful for you and your constituents.
Please feel free to contact me if you have additional questions or
concerns.
Sincerely,
Richard D. Klausner, M.D.,
Director, National Cancer Institute.
Enclosures.
Public Law 105-18
CHAPTER 6
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
public health and social services emergency fund
For expenses necessary to support high priority health research,
$15,000,000, to remain available until expended: Provided, That the
Secretary shall award such funds on a competitive basis.
______
Conference Report 105-119
LABOR, HEALTH AND HUMAN SERVICES, EDUCATION AND RELATED AGENCIES
Office of the Secretary
public health and social services emergency fund
The conference agreement modifies language proposed by the Senate
which would have appropriated $15,000,000 to the Public Health and
Social Services Emergency Fund within the Office of the Secretary for
competitively awarded research on the environmental links to breast
cancer. The Senate language designated the funding as an emergency
appropriation. The House bill had no similar provision.
The conferees agree that $15,000,000 is appropriated to support
high priority biomedical research. These funds will be made available
on a competitive basis and through mechanisms to be determined by the
Secretary, in consultation with the Directors of the National
Institutes of Health and the Centers for Disease Control and
Prevention, and the Deputy Assistant Secretary for Women's Health. The
conferees request that the Secretary provide a report to both
Committees on the research plan and allocation methodology accompanying
these additional funds by July 1, 1997. Among the priorities the
conferees encourage the Secretary to consider is cancer research,
especially research investigating the environmental factors that may be
associated with breast cancer in communities with high incidence of the
disease. The conferees have removed the emergency designation for these
funds, offsetting the cost elsewhere within the bill.
______
Department of Health & Human Services,
Public Health Service, National Institutes of Health,
Bethesda, MD, February 23, 1998.
Hon. John Edward Porter,
Chairman, Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies, Committee on Appropriations, House of
Representatives, Washington, DC.
Dear Mr. Porter: On December 19, 1997, in response to the
Conference Report accompanying the Fiscal Year 1997 Emergency
Supplemental Appropriations Act (Public Law 105-18), the Secretary of
Health and Human Services submitted to you our research plan for using
the $15 million appropriated in the Act for high-priority health
research. However, after further internal discussion, we have notified
the Secretary and are now notifying you that we believe we can improve
upon our original project design for the $12 million we intend to use
to study gene-environment interactions in the cause of breast cancer in
high-risk areas of the United States. Our updated research plan is
enclosed. Please note that this revision still conforms with the
legislative requirement that all of these funds be awarded on a
competitive basis.
Instead of a single, multi-year, multi-center, case-control study
as originally envisioned, we have determined it would be more
appropriate to break out the funds into four types of projects, with
most of these funds awarded in fiscal year 1998. The first project
would be a contract for a Geographic Information System for the Long
Island Breast Cancer Study to identify potential environmental risk
factors for breast cancer. The National Cancer Institute (NCI) plans to
issue a Request for Proposals for this contract in late winter or early
spring of 1998 for award in fiscal year 1998. The second and third
projects would include research grants in the specific areas of
``Addressing Environmental Factors and Breast Cancer in High-Risk
Areas'' and ``Interdisciplinary Collaborative Studies of Gene-Gene and
Gene-Environment Interactions in Breast and Other Cancers.'' Requests
for Applications (RFAs) for grants in these two areas are expected to
be issued in the spring of 1998 and awarded in fiscal year 1998. A
third RFA for research grants on developing and testing accurate
exposure assessments for breast cancer epidemiology is still being
developed and will be advertised and awarded in fiscal year 1999. We
expect to find many different research grants with a multiplicity of
study designs through each of these RFAs. Both NCI and the National
Institute of Environmental Health Sciences will contribute the
expertise of their staffs to these projects, with NCI to have the lead
responsibility for oversight of the project.
The portion of the original research plan related to spending $3
million for research on the adverse health effects of exposure to air
pollutants, such as ground level ozone and particulate matter, has not
been revised in this update. Specific announcements regarding the award
of funds for this project are still under development.
Thank you for your continuing strong support for medical research.
Sincerely,
Harold Varmus, M.D.,
Director.
Enclosure.
A Study of Gene-Environment Interaction in the Etiology of Breast
Cancer, in High-Risk Areas of the United States
[February 23, 1998]
The special legislation (Fiscal Year 1997 Emergency Supplemental
Appropriations Act) directing research on the environmental causes of
breast cancer provides a remarkable opportunity to better understand
the determinants of that disease through an innovative,
interdisciplinary initiative that encompasses the expertise of the
National Cancer Institute (NCI) and the National Institute of
Environmental Health Sciences (NIEHS). Decades of research have
established that the causes of breast cancer may involve environmental
factors and genetic elements that are also likely to be highly
interactive in producing the disease. However, the identification of
the specific exposures and array of genes involved has proven elusive.
Recent profound innovations in assessment of exposure to environmental
contamination and molecular genetic technology have raised the
expectation that we now have the tools to gain major new insights into
potentially preventable causes of many diseases such as cancer, and
into breast cancer in particular. It is clear that the time is ripe for
studies focused on gene-environment interactions in the risk of breast
cancer. Identification of environmental influences on genetic effects
should clarify the biologic mechanisms involved, and discovery of genes
that modify such effects should help identify the specific
environmental agents and host factors responsible for breast cancer.
All of the studies funded through this initiative will be
accomplished via extramural competitive research funding. These studies
will expand the existing portfolios of both Institutes in environmental
causes of breast cancer. Studies will be funded for a variety of
scientific approaches, including the development and application of
geographic information systems for the identification of potential
environmental risk factors for breast cancer, the development and
testing of accurate exposure assessment in breast cancer epidemiology,
the study of environmental factors for breast cancer in high risk
areas, as well as molecular and genetic epidemiology studies of gene-
environment interaction in breast cancer. A multiplicity of study
designs is envisioned. Such a breadth of approaches will provide truly
new and innovative opportunities not only to clarify genetic and
environmental determinants that are currently under suspicion as
causative of cancer, but also to establish bio-specimen resources
within epidemiologic infrastructures which can be revisited to evaluate
etiologic questions as they will arise in the future. The selection of
meritorious projects through the peer review process will assure that
the most scientifically excellent programs, totaling $12M, will be
selected, thus assuring that such studies will provide an important,
productive and efficient way to exploit our rapidly expanding
scientific and biotechnology knowledge base to identify preventable
causes of breast cancer. Investment in new approaches to studying gene-
environment interactions as they relate to breast cancer, if
successful, will provide a paradigm for new programs of
interdisciplinary studies into the origins of other cancers, as well as
many chronic diseases.
Total project cost: $12 million
______
A Study of the Adverse Health Effects of Air Pollutants, Particulate
Matter and Ozone
[February 23, 1998]
The Fiscal Year 1997 Emergency Supplemental Appropriations Act also
provides an opportunity to elucidate further the adverse heath effects
of exposure to air pollutants and particulates and the role of such
exposure in the causation of diseases such as asthma, lung cancer and
respiratory distress syndrome. The National Heart, Lung and Blood
Institute (NHLBI), the National Institute of Environmental Health
Sciences (NIEHS), the National Cancer Institute (NCI), and the National
Institute of Allergy and Infectious Diseases (NIAID) all have
portfolios of competitively awarded grants which study the underlying
causes of asthma, emphysema, hyperresponsiveness of the airways and the
premalignant and malignant changes in the cells of the lining of the
airways. Building on this knowledge base, new awards will focus on the
roles of a single exposure or multiple exposures to ground level ozone,
of exposure to particulate matter, and the combination of such
exposures along with other predisposing factors to respiratory
problems. After a national competition and peer review of applications,
awards will be made to the most scientifically meritorious applications
and will place emphasis on new molecular diagnostic and therapeutic
techniques which clarify the influence of these environmental
pollutants on genetic factors and other biologic mechanisms which
predispose the population of this country, particularly the young, and
the socio-economically disadvantaged to diseases such as asthma, lung
cancer, emphysema and other respiratory distresses. These awards will
maintain a separate identification so that they can be tracked to this
initiative.
Total Project Cost: $3 million to be shared by NCI, NHLBI, NIEHS,
and NIAID dependent on the number and size of individual grant awards.
______
DISPOSITION OF 1997 EMERGENCY SUPPLEMENTAL APPROPRIATIONS
[Dollars in millions]
----------------------------------------------------------------------------------------------------------------
Fiscal
Plan initiative Actual initiative Resulting projects Funding year
----------------------------------------------------------------------------------------------------------------
Geographic Information System......... Geographic Information Contract awarded to $2 1999
System NO2-PC-95074. Averstar, Vienna, VA.
Addressing Environmental Factors and Regional Variation in 5 new grants (UO1)....... 1.6 1999
Breast Cancer in High Risk Areas Breast Cancer Rates in EMF study /LIBCSP .4 1999
(RTA). the United States RFA: (supplemental funds for
CA-98-017 (reissue of CA- U01).
93-024) (with NIEHS).
Interdisciplinary Collaborative Interdisciplinary Studies 5 grants (U0I)........... 5 1999
Studies of Gene-Gene and Gene- in the Genetic
Environment Interactions in Breast Epidemiology of Cancer
and Other Cancers (RIA). RFA: CA-98-018 (with
NIA).
Exposure Assessment Techniques (RIA).. Implementation of the 3 grants (R01)........... .6 1999
National Occupational
Research Agenda KRA: OH-
99-002 (with NIOSH/CDC
and NIEHS).
Mechanistic-Based Cancer 1 grant (ROI)............ .2 1999
Risk Assessment Methods
RFA: OH-99-003 (with
NIOSH/CDC, NIEHS, and
EPA).
New RFA for 2000 (with ....................... \1\ 2.2 2000
NIEHS).
----------------------------------------------------------------------------------------------------------------
\1\ Estimate.
Environmental Factors and Cancer--$12 million set aside (Coordinated by NCI).
Adverse Health Effects of Air Pollutants--$3 million set aside (Coordinated by NHLBI).
Senator Specter. Thank you.
Dr. Kirschstein. Thank you.
Additional committee questions
Senator Specter. Thank you very much. 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
nih doubling: future implications
Question. What happens after doubling? What are NIH's plans to
maintain the ``doubled'' NIH after the 5th year--how will we avoid
large cuts in the number of new grants, and even the total number of
grants, as NIH funding moves to a maintenance level of some sort? Can
you prepare some grant-funding scenarios for us so we can see what the
implications would be of maintaining NIH at biomedical inflation, as
well as some higher levels, in the years beyond 2003?
Answer. We recognize that Congress has stated its intention to
double NIH's budget by fiscal year 2003 and appreciate the support the
Congress has provided in the past three years. For responsible
management, we have begun to consider the impact of similar increases
in fiscal years 2002 and 2003 on NIH activities and biomedical research
in general, and to consider scenarios for support of research in the
years beyond fiscal year 2003. Any specific proposals for future NIH
budgets, whether for overall budget requests or specific grant-funding,
would be determined through the normal Executive branch budget process
that considers overall fiscal constraints and competing priorities.
Although at this time we cannot outline any specific proposals for
NIH's future activities, for the purposes of answering this question,
below are some preliminary grant funding scenarios.
For the purposes of answering this question, we have assumed
increases of 15.2 percent in fiscal year 2001 over fiscal year 2000,
and increases of 15.4 percent each in fiscal year 2002 and fiscal year
2003 that would complete a five-year doubling effort begun in fiscal
year 1999.
Using these assumptions, NIH estimates that by fiscal year 2003, we
would fund nearly 12,000 competing RPGs, with average cost increases of
5 percent provided each year for these awards. In answering this
question, NIH assumed that Research Centers, Other Research, and
Research and Development (R&D) Contracts would increase by 16 and 18
percent in fiscal year 2002 and fiscal year 2003. NIH would maintain
full-time training positions (FTTPs) at a level of 16,446, with
inflationary increases provided for stipends, tuition allowances, etc.
NIH funding would need to continue to increase in real terms if the
number of competing RPGs were to be maintained at the fiscal year 2003
level. For the three years following fiscal year 2003, if the NIH
budget in total were maintained with increases equal to the Biomedical
Research and Development Price Index, currently estimated at
approximately 3.6 percent, then the number of competing RPGs NIH could
fund would likely decrease by over 20 percent, or approximately 2,500
grants, from nearly 12,000 in fiscal year 2003 to 9,500 in fiscal year
2004. With the exception of those mechanisms requiring payraises, other
mechanisms would be held flat. In fiscal year 2005, numbers of grants
would continue to decrease, dropping by over a thousand to 8,200. This
would be nearly 3,800 and 32 percent fewer competing RPGs than in
fiscal year 2003. In fiscal year 2006, numbers of competing RPGs would
increase by 1,400 to 9,600, still well below the fiscal year 2003 level
of 12,000 competing RPGs.
Alternatively, if NIH were to receive total increases ranging from
8 percent in fiscal year 2004, to 10 percent in fiscal year 2005, and 7
percent in fiscal year 2006, we could maintain the number of competing
awards at the fiscal year 2003 level and avoid the increases and
decreases described above. Inflationary average cost increases are
assumed for RPGs and all other mechanisms.
If, under a third scenario, NIH were to receive increases of
approximately 10 percent, 11 percent, and 9 percent, respectively,
between fiscal years 2004-2006, the number of competing RPGs could be
maintained at the fiscal year 2003 level of nearly 12,000 and small
increases above inflation would be provided in both competing RPGs and
other research mechanisms. Average cost increases greater than
inflation for competing RPGs would recognize that future investigators
will increasingly use scientific databases, sources of specialized
animals and sophisticated instrumentation to achieve scientific
advances. NIH believes that sustained, stable support is vital to
optimize the benefits of the long-term investment needed for progress
in biomedical research.
More and more, we find that multidisciplinary teams are needed to
solve big problems in research. The laboratory of the future will
almost assuredly be driven by computer applications and technologies.
While recognizing the importance of RPGs, we see that other mechanisms
offer unique opportunities to bring together multiple disciplines and
centers to pursue research questions, and this scenario also provides
modest program growth for these other mechanisms. Under this approach,
we have also assumed continued expansion of clinical research programs
in all mechanisms, including the Clinical Research Career Development
programs, Clinical Research Centers, Cooperative Clinical Groups, and
intramural clinical research in order to speed medical breakthroughs at
the bedside that will lead to improvements in treatments and
interventions to decrease mortality and morbidity, and improve the
quality of life. In addition, we have assumed in the third scenario the
same number of FTTPs in our research training program as in fiscal year
2003, with inflationary increases for stipends.
Modern facilities are required for molecular medicine and genetic
research. Continuing support of such infrastructure elements would also
be a key component of our overall strategy for sustaining capacity for
world class medical research. Furthermore, it will be important for NIH
to have sufficient capacity to manage research portfolios and to ensure
appropriate stewardship of funds. Consequently, NIH's Research
Management and Support activity and the Office of the Director would
receive adequate increases to enable NIH to continue to assure the
public that its trust is well founded.
The fiscal year 2001 President's Budget proposed a strategy of
providing average cost increases of 2 percent over fiscal year 2000 for
RPGs, to control the growth of continuing commitments and support
planned new and expanded initiatives. If NIH continues on the doubling
path, then we can consider different approaches for managing funding
increases in the best interest of scientific progress and long-term
budgetary discipline.
The pace of new discoveries in the biomedical sciences is now
occurring at a breathtaking rate. The explosion of new knowledge that
has resulted from our explorations of the human genome and the biology
of the cell is providing new opportunities to further understand
disease, as well as new and innovative ways of treating, diagnosing,
and preventing illness. Untapped resources for developing and testing
new ideas--in other words, unused capacity--will remain available in
the research enterprise in the future. The more new ideas that are
explored and the more rapid the effort, the sooner these findings will
be available for translation into medical practice.
NIH looks forward to working with Congress to ensure that NIH's
funding increases support the highest quality research in a fiscally
manageable and responsible manner.
stem cells
Question. When will you begin funding research grants involving
embryonic stem cells provided they meet peer review?
Answer. NIH will consider requests for new funds, supplemental
funds or use of ongoing grant or intramural funds as soon as the NIH
Guidelines are finalized and there is an oversight process in place.
Question. What do you think has been the negative impact on stem
cell research from the year and half long delay we have had waiting for
the NIH guidelines to be put in place?
Answer. As soon as it is possible to use federal funds for this
research, more researchers will be able to participate and contribute
to this new arena of biomedical investigation. As more people are
involved, it is conceivable that progress may proceed more quickly.
Question. Some have raised concerns about fetal tissue research and
possible violations of the law concerning profiting from the sale of
fetal tissue research. Do NIH funded scientists spend more than the
appropriate funds charged for fetal tissue? Or do they pay a flat fee
that simply covers the cost of processing and transporting the tissue?
Answer. All NIH funded researchers are required to follow the
local, state and Federal laws governing fetal tissue research. There is
a Federal law that prohibits an individual or entity from profiting
from sale of human fetal tissue. It also prohibits any individual or
entity from knowingly acquiring fetal tissue from another entity for
``valuable consideration.'' According to this law, ``valuable
consideration'' does not include reasonable payments associated with
the transportation, implantation, processing, preservation, quality
control, or storage of human fetal tissue. Violation of this statute
carries criminal penalties. There is no evidence that NIH funded
researchers spend more than appropriate charges. Appropriate charges
for processing and transportation of fetal tissue may or may not take
the form of a ``flat fee.''
Question. How would stem cell research be impacted if fetal tissue
research were restricted?
Answer. If Federally funded researchers were no longer permitted to
conduct research using fetal tissue, they would not be able to either
derive human pluripotent stem cells from fetal tissue or conduct
research using human pluripotent stem cells derived from fetal tissue.
grants review process
Question. This Subcommittee receives many complaints from advocacy
groups that certain fields of research are underfunded because of the
current structure of the grant review system. What are you doing to
address the concerns of researchers and advocates in those underfunded
fields?
Answer. The Center for Scientific Review (CSR) conducts the review
of approximately three-fourths of the grant applications submitted to
NIH, including almost all investigator-initiated applications. The
study sections that review these applications were established over a
period of many years. Although the content of the science reviewed in
CSR's study sections has evolved as the research enterprise developed,
there had never been a systematic assessment of whether the current
study sections are appropriate for the review of today's (and
tomorrow's) scientific opportunities in the health-related research
areas.
In 1998, CSR convened a distinguished panel (the Panel on
Scientific Boundaries for Review) of scientific leaders from diverse
fields of biomedicine to conduct an overall assessment of the structure
and functions of its peer review system, and to propose changes needed
to better align the system with the current research landscape and
scientific opportunities. The Panel engaged in extensive outreach to
the broad research community so as to solicit input and encourage
dialogue. The Phase 1 recommendations were posted on the web for
several months, and over 800 comments from professional societies and
individual researchers were received and considered. Numerous meetings
and teleconference calls were held among Panel members, the director of
CSR and her staff and concerned representatives from advocacy groups
and professional societies. A revised Phase 1 report was presented and
accepted by the CSR Advisory Committee in January, 2000. The thrust of
the proposed reorganization involves the distribution of research grant
applications for review to a group of committees that form a cluster
focused on a particular disease or organ systems, in order to stimulate
the identification of the best scientific approaches to such a unit.
The second phase of the Panel's activity has just begun and will
define the boundaries of the individual study sections that will
populate the new clusters of review groups. Again, this will be
accomplished with extensive participation by the relevant research
communities, which will ensure that new directions and newly-emerging
scientific areas will be accommodated and that all types of research
approaches will receive a fair and appropriate review. An
implementation plan for Phase 2 has been developed and posted on the
NIH website, and CSR is currently beginning work on the first new
cluster of study sections.
In addition to the major re-structuring of CSR, individual
Institutes have responded to advocacy groups by (1) organizing
workshops to identify potential research opportunities for the
development or refinement of diagnoses, and therapies and the further
understanding of specific diseases, and (2) issuing specific requests
for applications (RFAs) that address areas that are recognized to
require stimulation. Responses to these RFAs are reviewed by special
review committees convened specifically for that purpose by the funding
Institutes.
Question. Some institutes are taking steps to involve members of
the public on certain scientific peer review panels. How are these
efforts working out? What contributions can lay reviewers make to the
process?
Answer. The National Cancer Institute, the National Institute of
Allergy and Infectious Diseases, the National Institute of Mental
Health, and the National Institute on Drug Abuse involve members of the
public on their peer review panels. A description of their involvement
follows:
National Cancer Institute
The NCI has increasingly involved consumers on Institute-based
scientific peer review panels for grant applications and contracts
proposing clinical trials of new cancer treatments. NCI has expanded
the involvement of members of the public to include lay reviewers/
consumers on all NCI scientific peer review panels for clinical and
population based research. This includes review panels for Cancer
Centers, Cooperative Clinical Trials Groups, Specialized Programs of
Research Excellence (SPOREs), clinically oriented Program Projects, and
projects submitted in response to Requests for Applications (RFAs).
Most Cancer Center, Cooperative Group, and Program Project applications
require a site visit to the applicant institution prior to the formal
review committee meeting, and consumers participate in the site visit
as well as in the subsequent review committee for these applications.
NCI review staff worked with the NCI Office of Liaison Activities (OLA)
and the NCI Director's Consumer Liaison Group (DCLG) to develop
criteria for selecting consumer reviewers. In response to input from
consumers, NCI developed a Consumer's Guide to Peer Review and a
Consumer's Cancer Dictionary for Peer Review to facilitate
participation of lay members on review panels. Consumers have been used
in almost 60 reviews during the past 18 months.
Consumers participate actively in discussions, present the patient
perspective in discussion, and vote on the applications. Consumers
provide an important additional perspective on the proposed research in
the following areas: factors that may affect study design; feasibility
of plans for patient recruitment, retention and follow up of subjects;
feasibility of protocols in regard to specific populations (e.g.,
complexity, compliance); clarity and patient acceptability of
protocols; feasibility of protocols in the context of total patient
care; cultural and socioeconomic aspects of protocol implementation;
outreach and special challenges (e.g., need for multi-cultural research
staff, composition and role of the Community Advisory Board, etc); and
ethical issues, including human subject protection, adequacy of
informed consent forms and inclusion of women, minorities, and children
in clinical research. In addition, as they review applications, they
may consider whether the proposed research is applicable to cancer in
terms of prevention, cause, detection, treatment, care, quality of
life, and/or other pertinent issues. Feedback to NCI from both
consumers and scientific reviewers is obtained and indicates that the
system is working very well.
One striking effect of use of consumers in the peer review process
has been its effects on applicants. There has been a noticeable
increase in documented consumer input in research proposals as
evidenced by the participation of consumers in various structural and
advisory capacities within applicant organizations.
National Institute of Allergy and Infectious Diseases
The use of members of the public on NIAID review committees, where
they can contribute essential insights to the overall evaluation, is a
thoroughly considered and well-precedented practice that NIAID
considers to be an important component of the responsible conduct of
the peer review of patient oriented research. Public members make
important contributions and can bridge the communication and knowledge
gap between scientists and the patient base they serve. The NIAID has
been actively involving members of the public on certain scientific
peer review panels over the last ten years, and the following data
summarize some of the experiences:
--Public members bring very unique multi-faceted perspectives of the
disease/condition/subject to the review group resulting in
better decisions.
--They have a very high interest in the research and the process of
thorough evaluation of applications to determine which have the
best scientific merit.
--Their knowledge of certain diseases and the people affected by
those diseases enables the public members to provide valuable
input and expertise as reviewers and to raise important
questions in several aspects of the research, for example,
clarity of protocols, consent forms, and the feasibility of
complicated protocols for certain patients.
--Since at least 1991, the NIAID special review committees have
included patient and lay representatives of the target
populations for selected large clinical efforts including: the
AIDS Clinical Trials Groups (ACTG), the Pediatric ACTG, the
Women's Interagency HIV Study, the Multi-center AIDS Cohort
Study, and the AIDS Vaccine Evaluation Group. However, the
NIAID does not include members of the public on committees in
which patient recruitment and retention is not an issue, for
example, basic science initiatives.
--The NIAID believes that proposed research efforts, the overall
success of which depends upon the successful recruitment and
retention of patient populations, must be evaluated on the
quality, appropriateness, and feasibility of the proposed plans
for recruitment and retention. So important is this aspect of
the plans that the review criteria specifically include
recruitment, retention, and related community outreach issues.
--As with selection of any reviewer, special care needs to be taken
to select individuals with the appropriate expertise.
The NIAID also believes the review committees need to include all
types of expertise relevant to making an informed assessment of the
merit of the applications, and that patients or members of the public
provide insights regarding the quality, appropriateness, and
feasibility of plans for recruitment, retention, and community
outreach. This is viewed as one of the essential types of expertise
that should be brought to bear upon the overall judgement.
Public members of the NIAID review committees have review
assignments in which they are asked to comment on the recruitment,
retention and outreach aspects of the proposals. Their contributions
are generally valued and appreciated by other (scientific) reviewers.
They are full-scoring participants in the review meeting and constitute
a small percentage of the voting members of any of these review
committees.
Like all reviewers, the public members are asked to comment on
aspects of the applications related to their personal expertise, and to
score the applications on overall merit as best they can, having
listened to the discussion of all other reviewers. In our experience,
the scores assigned by the public members have been remarkably
consistent with scores assigned by other reviewers.
In summary, the NIAID applauds the efforts of members of the public
on peer review committees, and recognizes that additional members may
contribute a perspective that is perhaps sometimes difficult for a
scientific specialist to appreciate.
National Institute of Mental Health
Public participant reviewers have successfully served for a year on
the NIMH's service and interventions review committees. Public
reviewers included individuals who have suffered from mental disorders,
family members of those suffering from mental disorders, policymakers
in the mental health care arena, and mental health care providers. All
committee members were asked for their assessment of how well the
process worked. The most common feedback was that the inclusion of
public reviewers was useful and that the public reviewers had done an
excellent job. The public reviewers, many of whom experienced the
committee process for the first time, were impressed with the efforts
of the committee members and the serious and objective nature of the
deliberations. NIMH will continue to request feedback from all
reviewers to help inform and improve the process of public
participation in its review meetings. Future plans are to help public
reviewers focus on the review issues to which they can best contribute
such as determining public health importance and human protection
issues, and to continue adding and training new public reviewers to
ensure a broad diversity of opinions and experiences.
National Institute on Drug Abuse
NIDA is in the process of planning the recruitment and training of
public consumers to act as reviewers for the treatment and services
review panels. These public members will provide an important point of
view, commenting on issues such as feasibility of the research,
practicality of the proposed intervention, and appropriateness of human
subjects protections.
nih buildings and facilities
Question. Dr. Fischbach and Dr. Hyman, the Budget requests funding
for a new National Neurosicence Research Center, at a cost of $73.3
million. How will this ``integrated neuroscience program'' enhance
neuroscience research at the NIH? Will the broader research community
benefit from this?
Answer. The most significant feature of the integrated neuroscience
program is that it will speed the translation of scientific discoveries
into new, clinically useful strategies for disease prevention and
treatment. Sustained interactions between basic and clinical scientists
are needed so that each group can be better informed about the
opportunities offered by the other. In the more typical academic model,
basic neuroscientists are segregated in one or more preclinical
departments, quite removed from colleagues in clinical departments of
neurology, psychiatry, neurosurgery, medicine, and anesthesiology.
Input from the engineering, mathematics and physical sciences is
minimal. This new integrated neuroscience program has a rare
opportunity to set a high standard for the entire nation by ``putting
the brain back together'' without regard to the artificial boundaries
of Institute or medical school organization. Beyond the obvious medical
disciplines, we will integrate bioengineering, computational science
and bioinformatics as more equal partners in research in the
neurosciences. In so doing, we will support and enhance the patient-
oriented research that will be conducted in the new Mark Hatfield
Clinical Research Center.
Each of the Institutes that will participate in this program was
created with a distinct patient population in mind, and they fund
research that is of special interest to their different constituencies.
However, they share many areas of neuroscience research. For example
common mechanisms of nerve cell degeneration probably underlie
Alzheimer's disease, vascular dementia, blindness, hearing loss, and
stroke. Common alterations in the actions of neurotransmitters, such as
dopamine, probably underlie thought disorders such as schizophrenia,
movement disorders such as Parkinson's disease, substance abuse
problems including alcoholism, and the suffering due to chronic pain.
Thus, the mission of each Institute would be better served by a
coordinated effort on the NIH campus.
We plan to bring together, under one roof, NIH scientists who are
now isolated from one another simply because of outdated historical
precedents. Research will be organized, and resources allocated,
according to scientific themes, not Institute identity. We will also
cooperate in filling gaps in our research programs by recruiting the
very best new scientists to the NIH campus.
The broader research community will benefit in many ways. One of
the most exciting elements of this plan is the opportunity to attract
and train the most talented young scientists, many of whom will return
to the extramural community. We also envision enhanced opportunities
for intramural-extramural collaboration, both on specific projects and
through mechanisms that will allow the appointment of academic
scientists to short-term positions at NIH. In addition to bringing
individuals and teams of scientists together, the program will provide
unprecedented opportunities for extramural scientists to take advantage
of resources such as animal models, genetic tools, and state-of-the-art
imaging devices. Perhaps most importantly, our program will serve both
as a model to reinforce similar efforts in the broader community and as
a template for developing strong neuroscience research programs in
institutions that do not presently have them.
Question. Is this $73 million the total cost of the entire project,
or is there another phase to come later, and if so, how much is the
total cost?
Answer. The B&F request includes $47.3 million in fiscal year 2001
and requests advance appropriations of $26 million in fiscal year 2002
for the initial phase of construction to replace Building 35. In fiscal
year 2000 the NIH plans to request a reprogramming of $5 million from
other B&F projects to fund the design/construction documents for the
initial phase of construction. We are considering a second phase to the
NNRC project. A decision on the scope and cost of any potential phase
will be made through the normal Executive branch budget formulation
process.
Question. What types of research will you be able to conduct in the
new center that you are unable to do with your present facilities?
Answer. As noted earlier, we believe the planned center will
provide an optimal environment for translational research. However, its
distinguishing feature will not be research on specific topics so much
as an innovative process and environment for conducting
interdisciplinary, collaborative research without regard to
organizational boundaries. The importance of this can hardly be
overstated in the context of what modern neuroscience is teaching us
about the brain and its disorders.
Question. Are other important activities needing B&F funds being
put on hold in order to undertake this project?
Answer. The fiscal year 2001 B&F request provides a level of
funding to initiate or continue support for three of the highest
priority projects of the National Institutes of Health (NIH): the
National Neuroscience Research Center (NNRC), the Central Vivarium, and
the Modernization of Building 6. The remaining funds in the request are
sufficient to maintain continuity of essential and enabling projects in
support of the research facilities infrastructure of the NIH.
national cancer institute
Question. Dr. Klausner, shortly after you became NCI Director, you
began a new research initiative called the Cancer Genome Anatomy
Project to identify all of the genes involved in cancer. Can you tell
us whether that project has produced any results?
Answer. This project has been extremely successful, identifying
tags for the vast number of human genes, annotating what types of cells
and cancers express those genes, developing catalogues of chromosomal
changes in cancer and discovering common genetic variations that will
help to explain why individuals are different in their risk of getting
cancer, their sensitivity to diet and the environment and their
responses to therapy. CGAP has become one of the most widely used
sources of information and reagents in the research world
(www.ncbi.nlm.nih.gov/ncicgap/).
In the past three years, the CGAP Tumor Gene Index has discovered
more than 40,000 previously unknown expressed human genes, representing
about one-half of all known human genes and has produced more than
900,000 DNA sequences. CGAP has discovered approximately 3,800
previously unknown genes expressed in the breast, colon, lung, ovary,
and prostate and has now extended this analysis to all major forms of
cancer. These new genes are already the subject of follow-up studies to
assess their potential for defining molecular signatures for normal,
precancer, and cancerous tissue.
We expect that having these molecular signatures of cancer will
afford new opportunities to catalyze all areas of cancer research
including cancer predisposition, development, prevention, detection,
prognosis, and therapy. For example, CGAP discoveries may provide the
platform for molecular signatures of the earliest stages of cancer
development, thereby facilitating prevention research.
In the area of therapy, understanding the molecular nature of
cancer will spur efforts to develop new drugs with improved
effectiveness and reduced side effects because the drug design will be
based the precise molecular profiles of tumors and the patients. In
addition, identifying early molecular events in cancer will afford new
opportunities to therapeutically target earlier stages of cancer
development. NCI is working actively to build a strong interface of
CGAP with the basic and clinical research communities in academia and
industry to assure that these new resources are effectively utilized.
In addition, the NCI will continue to build additional
infrastructure (data, technology, informatics tools) to assure that
maximal value is obtained from the CGAP project. Toward that end, the
NCI has implemented several CGAP inter-related components designed to
provide an information and technology infrastructure for the biomedical
research community. One of these components, the human tumor gene index
(TGI), was fully implemented in May 1997 with the initial goal of
identifying genes expressed during development of tumors in five major
cancer sites--breast, colon, lung, ovary, and prostate. For breast
cancer, the TGI has produced more than 17,000 DNA sequences from 11
cDNA libraries derived from human breast tissue and tumors, resulting
in the categorizing of about 5,700 genes expressed in human breast
cancer.
Active efforts in the research community are being directed at
assessing the potential value of these newly discovered genes as
markers for cancer development. These projects include laboratory
studies of how environmentally-induced genetic alterations leading to
altered function of a mutant protein contribute to the abnormal growth
pattern which characterizes tumors. Epidemiologic studies too are
focusing on the role of genetic variations possibly induced by
environmental agents. Of particular interest are studies of the enzymes
which metabolize environmental agents or steroid hormones, and
alterations in the genes which code for these enzymes.
Question. What is NCI's/NIH's role in international cancer
research? Please describe for the committee what NCI's role has been in
the development of the historic All-Ireland Cancer Center.
Answer. NCI, in cooperation with extramural institutions and the
Fogarty International Center of the NIH, supports international health
research through bilateral agreements, grants, and contracts. The
Institute supports some 1,000 Visiting Scientists and Exchange
Scientists. The work of outstanding scientists throughout the world is
supported through fellowships, cooperative projects, exchanges of
personnel and materials, and workshops. During fiscal year 1999, NCI
obligated approximately $45 million for foreign grants and contracts,
the NIH Visiting Program, bilateral scientist exchanges, workshops, and
international dissemination of cancer information. NCI's international
effort, coordinated by the Office of International Affairs (OIA) within
the Office of the NCI Director, works in conjunction with programs
within NCI's divisions, at other NIH Institutes and the Fogarty
International Center.
The All Ireland--National Cancer Institute Cancer Consortium
The NCI has recently embarked on an international partnership with
the developing Cancer Programs on the Island of Ireland (Northern
Ireland and the Republic of Ireland) in an attempt to improve the
quality and range of cancer services available for patients in Ireland.
This Transatlantic Partnership, called the All Ireland-NCI Cancer
Consortium seeks to strengthen cancer treatment, education and research
programs as the cancer communities from both the Republic of Ireland
and Northern Ireland prepare to join in a unique agreement with the US
National Cancer Institute. I and several members of my staff had worked
closely with Chief Medical Officers of both Irish governments and other
key Ireland officials to develop this concept, and we were greatly
facilitated in this endeavor by our Irish ex-colleagues at the NCI.
Cancer is a significant cause of mortality and morbidity on the
Island of Ireland with Northern Ireland and the Republic of Ireland
having one of the highest incidence and mortality rates for cancer in
the Western World. Currently there are approximately 28,000 new cases
and approximately 11,000 deaths from cancer each year. Therefore, the
development/improvement of services for cancer patients has been a top
priority for both Northern Ireland and the Republic of Ireland. Given
the NCI's leadership in the cancer field, the leadership of Northern
Ireland and the Republic of Ireland felt it was timely to bring
international expertise such as the NCI on board as partners in an
effort to fuel the further development of cancer services in Ireland.
The major components of the NCI Ireland Agreement include the
following:
Education and exchange of scholars
Education forms one of the major platforms of this Agreement
through the support of educational programs for Medical, Nursing and
Scientific Staff. These programs will include the exchange of scholars,
including Ph.D., M.D., and nursing students. Particular emphasis will
be given to the exchange of medical and nursing trainees focused on
clinical research. This will have an immediate clinical impact and will
naturally extend the support that has already been given to the
training of medical and scientific trainees from the Island of Ireland.
Further exchanges would include Ph.D. students, laboratory based M.D.s
in training, clinical visiting professors and investigators from the US
wishing to extend their studies in Ireland.
Clinical Trials
Another major area for partnership will be the enhancement of
clinical trials infrastructure and clinical trial development.
Modernization of cancer care requires placing cancer delivery in the
context of evidence based medicine. This requires a vigorous and
contemporary clinical trials infrastructure that will center around the
clinical trials infrastructure already established at the Northern
Ireland Cancer Center and also the Clinical Trials organization in the
Republic of Ireland. The NCI has already commissioned the development
of a new Clinical Trials Information System (CTIS) which seeks as its
goal to implement international standards in institutionally based
clinical trials processes and has already committed significant
resources to its implementation. The outcome of this element of
partnership will be that clinical trials performed in these
institutions will immediately be compatible for collation, analysis and
presentation with studies performed in the United States. Moreover,
this system will allow participating centers to immediately conform to
international standards. This proposal therefore permits participating
institutions in Northern Ireland and the Republic of Ireland to quickly
achieve data management standards, which will exceed that of many
institutions.
Teleconferencing
Some teleconferencing capabilities and linkages are already
established between both partners in Ireland and the NCI. The further
investment in this infrastructure will facilitate cooperative clinical
trial development, education programs, patient services development and
exchange of clinical and scientific ideas. Communications will be
essential to the success of this partnership.
Tumor Registries
Another area for major collaboration and partnership will be in the
use of the Cancer Tumour Registries in both Northern Ireland and the
Republic of Ireland. The monitoring of improvements in cancer care can
only be a success with a reliable tumor registry that tracks population
based cancer incidence and mortality. These registries are now
available in both Northern Ireland and the Republic of Ireland, and
both Governments recognize their importance. The NCI will assist both
tumor registries by developing a common data base that can assist in
consultation, informatic tools and quality control. The consolidation
of the Registries in both the North and South will improve the overall
quality of data collection and provide information on a genetically
stable population. This will also act as a major tool for major
epidemiological investigations and development.
Developments in Cancer Clinical Services
The NCI Ireland partnership assists in the further development of
cancer clinical services programs on the Island of Ireland. This
includes the improvement and standardization of Radiation Oncology
practice and the development of a consolidated Radiation Oncology
program for research. There are a limited number of radiation
facilities on the Island of Ireland and there are significant needs in
terms of linking practice elements and the implement of uniform
standards of practice. The assistance in standardizing and driving the
development of clinical services will also extend to elements of
Medical and Surgical Oncology Practice as well as Palliative Care. The
development of Palliative Care Services is already at a very advanced
stage on the Island of Ireland and is one that the National Cancer
Institute will benefit from in terms of its own developing programs.
The NCI-All Ireland Cancer Conference
The NCI-All Ireland Cancer Conference held in Belfast in October
1999 was an important event that highlighted the commencement of this
special relationship. This Conference touched on clinical, laboratory,
epidemiological, and political issues that are pertinent to the care of
cancer patients. It highlighted important work by Irish, American and
European Scientists coupled with input from well-known international
academic and biotechnology investigators from across the world. This
international expertise was asked to discuss their areas of expertise
and comment on clinical and scientific programs that may help improve
North and South interaction and Transatlantic collaboration. All NCI
investigators were invited to participate in this conference.
Finally, the Conference punctuated the start of a very special
interaction on the Island of Ireland focused on the overall development
of cancer services for patients and also signaled the start of an
important partnership between the NCI and the practicing cancer
community in Ireland.
Question. What process does NCI use to set priorities? How does
this relate to the Bypass Budget initiatives?
Answer. To support the full range of research activities necessary
to conquer cancer, NCI uses a complex and dynamic process to set our
scientific and funding priorities. This process is driven by several
principles. Support the full range of research activities necessary to
conquer cancer:
--Strive for a balanced portfolio of research in behavior,
epidemiology, control, prevention, detection, diagnosis,
treatment, survivorship, rehabilitation, and end of life
issues;
--Give attention to the spectrum of distinct diseases we collectively
refer to as cancer and the various populations that experience
these diseases differently;
--Link all pieces of the cancer research enterprise through
translational research;
--Rely on our diverse constituencies to help us identify new
opportunities, gaps, and barriers to progress, create new
programs, and improve existing ones.
We integrate priority setting into all of our strategic planning
activities. These activities include identifying high priority
scientific opportunities, determining what is needed to build and
maintain our research infrastructure, and examining what is being done
and what needs to be done to tailor broadly applicable research to
specific cancers. All planning activities involve significant
participation from our advisory groups and the advocacy community.
Extraordinary Opportunities for Investment--Identifying Extraordinary
Scientific Opportunities
``Extraordinary Opportunities'' are areas where focused efforts and
increased resources could produce dramatic progress toward reducing the
burden of cancer. NCI identifies and prioritizes, with formal input
from cancer scientists, educators, advocates, and other cancer
community leaders, opportunities that:
--Respond to important recent developments in knowledge and
technology;
--Offer approaches that go beyond the size, scope, and funding of our
current research activities;
--Can be implemented with specific, defined investments;
--Can be described in terms of achievable milestones, with clear
consequences for investing; and
--Promise advances and progress against all cancers.
NCI Challenges--Building Critical Research Infrastructure
NCI plans for and supports research through a variety of
mechanisms, many of which provide funds tailored to specific research
processes. As part of an ongoing process of review and revitalization,
NCI has instituted a series of external reviews to guide us in
strengthening our major research support programs. In the past few
years, we have completed in-depth reviews of several programs: Cancer
Centers, Cancer Control, Clinical Trials, Cancer Prevention, and the
Development Therapeutics Program. We prioritize and plan to ensure a
research infrastructure that:
--Provides the vision, creative environments, and diverse resources
needed to increase the number of discoveries and advances in
cancer research and the scientific community's ability to apply
these findings to prevent and treat the many forms of cancer;
--Promotes and rewards innovative thinking, cross-fertilization of
ideas, and enhanced collaborations among government, academia,
and industry; and
--Develops and maintains the cadre of scientists required to
undertake the cancer research challenges of the future.
Tailoring to specific cancers
NCI must apply new discoveries and advances to specific forms of
cancer. The primary mechanism for cancer site-specific research
planning at the NCI is the Progress Review Group (PRG). Each Progress
Review Group is composed of prominent members of the scientific,
medical, and advocacy communities who know the state of the science
intimately and can provide a thoughtful, considered assessment of our
portfolio and recommend activities that will speed our progress. PRG
recommendations give the NCI a framework to determine whether or not
existing initiatives and programs are sufficient to aid the research
community in addressing priority areas. Where gaps are identified, NCI
modifies its plans to address unmet needs and encourages the research
community to undertake projects in key areas by clearly indicating
where NCI's priorities lie.
Participation from advisory groups and the advocacy community
NCI actively seeks out expert advice from a variety of advisory
bodies both within and outside the Institute. Scientific experts and
consumer advocates on the Presidentially appointed National Cancer
Advisory Board advise NCI's Director on issues related to the National
Cancer Program. The Board of Scientific Counselors and Board of
Scientific Advisors provide advice to NCI leadership on the progress
and future direction of NCI's Intramural and Extramural Research
Programs respectively. The NCI Executive Committee, which includes NCI
Division directors and other key advisors to the Director, meets
regularly to make major policy and operating decisions. The Director's
Consumer Liaison Group (DCLG) serves as a primary forum for discussing
issues and concerns and exchanging viewpoints important to the broad
development of NCI program and research priorities. The DCLG also helps
develop and establish processes, mechanisms, and criteria for
identifying appropriate consumer advocates to serve on NCI program and
policy committees; and establishes and maintains strong collaborations
between NCI and the advocacy community.
The annual Bypass Budget request is a key tool that NCI uses to
articulate the results of our on-going planning and prioritizing
process. Due to new scientific discoveries, advances in technology, and
the related changes in scientific thought, the Bypass Budget request
represents a snapshot, good for a relatively short time, of where NCI's
planning and prioritizing process indicates we need to go to take
advantage of new scientific opportunities in cancer research. As a
result, the Extraordinary Opportunities and NCI Challenge initiatives
outlined in the fiscal year 2001 Bypass Budget request represents the
focus of where NCI would put available funds. For example, with the
$420.4 million increased funding NCI received for fiscal year 2000, we
seized the opportunity to implement many of the initiatives identified
in the Bypass Budget request. 83 percent of the funding increase, or
$349.7 million of the $420.4 million increase, directly supported
initiatives in the Bypass--$124.9 million supported Extraordinary
Opportunities initiatives and $224.8 million supported NCI Challenges
initiatives (see figure below).
[GRAPHIC] [TIFF OMITTED] T07MA30.005
clinton/blair joint statement
Question. What was the significance of the joint statement issued
by the President and Prime Minister Tony Blair? Was this statement
intended to undermine research efforts in the private sector?
Answer. The President and Prime Minister Tony Blair agreed that it
was important to take notice, at the the highest levels of their
governments, of the progress the two countries have made in human
genomics and of the era of new opportunities unfolding before us. For
that reason, they issued a joint statement of position to help ensure
that human genomic discoveries are used as effectively as possible for
the advancement of human health throughout the world. The statement
consisted of two equally important, complementary principles, designed
to maximize scientific opportunities to understand the human genome, as
well as medical and economic opportunities for the development of
health care products.
--First, the statement reiterated the principle that raw fundamental
sequence data from the human genome--the ordering of the A's,
T's, C's, and G's that make up DNA--should be distributed as
broadly as possible, in an unencumbered manner, for use by
scientists around the world. This principle has been a
condition of funding by the Human Genome Project, which makes
genomic sequence data freely available over the Internet in a
public database called GenBank. New sequence data are deposited
daily by Human Genome Project participants.
--Second, the statement makes clear that intellectual property
protection for gene-based inventions will play an important
role in stimulating the development of health care products,
which will in turn allow the public to realize the full medical
benefits of the fundamental scientific discoveries. As a new
generation of medical discoveries begins to rely on gene-based
technologies, it is essential that we afford these technologies
the kind of intellectual property protection that has enabled
the development of every other wave of medical innovations.
No. The complementary principles described in the statement are
beneficial to both the private sector and the public. They reinforce
the public-private partnership that has fueled the genomics and
biotechnology enterprises, by enabling fundamental biological
discoveries as well as the entrepreneurship that can capitalize on
those discoveries and bring innovations to market. Key companies
involved in genomics were quick to issue statements endorsing the joint
statement.
human genome project
Question. Why did talks breakdown between the public Human Genome
Project negotiators and Celera Genomics? Do you see any way the public
Human Genome Project can maximize research dollars through
collaborating with private sector companies?
Answer. Representatives of The Human Genome Project, Doctors Martin
Bobrow, Francis Collins, Harold Varmus and Robert Waterston, met with
representatives of Celera Genomics Corporation on December 29, 1999, to
discuss a possible collaboration to sequence the human genome. At that
meeting Celera and Human Genome Project (HGP) representatives presented
quite divergent terms for such a collaboration. In a February 28, 2000,
letter to Celera, HGP representatives summarized the December 29, 1999
discussion and described how specific terms for collaboration presented
by Celera would conflict with the underlying principles of the Human
Genome Project to make sequence data rapidly and freely available to
all. On March 7, 2000 Celera Genomics President, J. Craig Venter
responded that Celera Genomics continues to be interested in pursuing
good faith discussions toward collaboration. On March 9, Dr. Collins
sent a letter to Celera indicating that he had received its letter and
would discuss possible next steps with the other HGP representatives.
human genome
Question. What are the likely developments in medicine over the
next 10 years that will result from unraveling the human genome?
Answer. The Human Genome Project will reveal all the human genes
and many of the variations in DNA that make individuals unique and
affect our susceptibility to disease. Scientists will understand the
genetic factors that influence the development of complex diseases--
like heart disease, diabetes, Alzheimer's disease, and cancer--that are
caused by several genes in interaction with each other and
environmental influences. Detailed understanding of the molecular
causes of disease will suggest new treatments.
In the next decade, predictive genetic tests will become available
for a few dozen complex diseases. If you find you are at high risk for
various ailments you will be able to adopt strategies (like changes in
diet, lifestyle, medical surveillance, and treatment with drug therapy)
to reduce your risk of becoming ill.
If you fall through that preventive medicine safety net and get
sick anyway, new treatments will begin to be available. Some likely
will be gene therapies. Others will be drug therapies designed on the
basis of an understanding of gene function. These therapies will be
more precisely tuned for the problem that you have and, because of
early diagnosis, will be available at an earlier stage in the disease
process. This new generation of preventive and therapeutic
interventions based upon your genetic information, which likely will
come along first for cancer, will revolutionize medicine and improve
our ability to prevent, diagnose, and treat the diseases that afflict
us and our families.
While both parties are open to continued discussions about the
terms of a possible collaboration, it remains unclear whether the
specific terms that meet the distinct goals of each of the two sectors
are possible.
Several productive public-private collaborations have marked the
Human Genome Project during its short history. For example, several
years ago, Merck & Company, Inc. decided to fund the generation of a
public collection of human EST (Expressed Sequence Tag or gene snippet)
sequences. More recently, on January 19, 1999 a memorandum of
understanding (MOU) was signed between Celera Genomics and the Berkeley
Drosophila Genome Project Group, a consortium of research groups
working at the University of California at Berkeley, Lawrence Berkeley
National Laboratory, Baylor College of Medicine and Carnegie
Institution of Washington. The group is funded by the NIH, the
Department of Energy and the Howard Hughes Medical Institute. The MOU's
stated purpose was to produce a complete, annotated, and publicly
accessible sequence of the Drosophila genome at a reduced cost and an
accelerated pace. The DNA sequence of the fruitfly, Drosophila
melanogaster was published in Science on March 24, 2000.
Presently, the National Human Genome Research Institute (NHGRI) is
working with a consortium of groups to develop a plan to identify an
estimated 700,000 single nucleotide polymorphisms (SNPs) (common areas
in the human genome where the sequence varies by a single letter) over
the next two years. The SNP Consortium (TSC) is a unique group of 10
pharmaceutical companies, IBM, Motorola and the Wellcome Trust of the
United Kingdom, in partnership with leading HGP academic centers.
Variant SNPs, that are identified, will be placed in the public domain
for all to use. Many of the variants will be responsible for traits
that distinguish one person from another. Others will be found to
contribute to an individual's risk of developing complex diseases such
as cancer, heart disease, and diabetes. The NIH and TSC have been
coordinating efforts since TSC's inception. For example, efforts by
both the NIH and TSC to discover SNPs are using DNA samples from the
NIH SNPs resource so that data from the two efforts will be comparable.
In addition, the SNP data generated from both projects are deposited in
the public database, dbSNP. Finally, NIH and TSC investigators
participate in joint scientific and technical meetings to share
information and coordinate strategies.
Each of these collaborations combine public and private resources
to generate genomic information that is freely accessible, without
restriction, to both public and private sector scientists. As a result,
more information has been available to the scientific community more
rapidly than expected. The NIH welcomes these opportunities by which
workable models for collaboration between the public and private
sectors can be achieved.
mouse genome
Question. Why is it important to sequence the mouse genome if you
already have the human genome?
Answer. The human genome is a very complex structure that will take
decades or even centuries to understand fully. One of the best tools
for understanding it is to compare it with other genomes. For example,
if a certain region in the mouse genome is almost identical to the same
region in the human genome, this is a clue that the region codes for an
important function. If the function of such a region of the mouse
genome is known, it can be deduced that the function of the human
region is the same or is similar. Because we have been studying on mice
for many years, we know a great deal about the biology of mice and
mouse genes, an area that is difficult to study in humans. As a result,
the ability to compare mouse and human sequence is expected to provide
a tremendous boost for understanding human genetics. For this reason,
having the sequence of the mouse is critically important.
sequencing of the human genome
Question. A working draft is useful, but what are your plans for
finishing the sequence of the human genome to high accuracy?
Answer. The Human Genome Project is committed to finishing the
human sequence to a level of high accuracy. This has been the goal from
the beginning of the project and it has not changed. The current plan
is for each group to finish those sections that it has sequenced to the
working draft status. An international working group has been
discussing the details of strategy for finishing the sequence over the
last few months and has come up with a plan that all have endorsed. The
goal is to complete this by 2003, but it may well be possible to finish
earlier.
human genome
Question. What plans does your institute have to encourage research
on understanding the genome, once the sequence is in hand? What role
will computers play in this next phase?
Answer. NHGRI has been supporting technology development for
research on functional genomics for some time. Recently we have
intensified our efforts by supporting two new initiatives. The first is
the Mammalian Gene Collection in collaboration with the NCI. This
project will assemble a catalogue of cloned and sequenced human genes
and make them available to researchers. This collection will be a
critical tool for understanding the human genome. In addition, NHGRI
will shortly issue a request for applications for Centers of Excellence
in Genomic Science. These centers will focus on novel approaches to
studying genomic questions. We expect that they will become centers for
technology development and computational biology, whereby new
methodologies are created that assist scientists in understanding the
human genome sequence and how it functions.
Databases, using computers, will store the information on DNA
sequence, DNA variants, and a large amount of information on gene
structure and function. Researchers will be able to access this
information from their lab computers. Using computers, they will be
able to analyze the data to discover more about how genes work, for
example, by comparing human with mouse sequence to find genome regions
important for gene regulation. They will also be able to use computers
to make discoveries by combining the genomic information with their own
research results, such as mapping genes for diseases.
children and depression
Question. Children and depression--Dr. Hyman, you have often said
that a depressed child is at quite a disadvantage in terms of ability
to learn, form relationships, and develop overall in a healthy way. It
is critical that each child in distress have the best possible chance
of being noticed and evaluated in a thorough, competent way. What
effect might failure to do this have on the apparently increasing
incidence of violence among children and adolescents?
Answer. We can only speculate on this, as studies which would
unravel the effects of untreated depression in children, for ethical
reasons, have not been undertaken. We agree that children who are
depressed can be identified, that valid assessment approaches are
available, and that some treatments and preventive strategies,
including school-based programs specifically for these children, have
been rigorously tested. A major problem is that too often these
treatments and preventive approaches are not available to children who
need them. Instead unevaluated programs are offered under the guise of
providing a ``service.''
There have been several longitudinal studies of children with
different patterns of risk, and these studies indicate that there is a
cumulative and negative effect to ignoring such risks. Children with
certain patterns of risks may go on to exhibit serious behavior
problems in adolescence. Many of these behavior problems can be avoided
by early detection, careful assessment, and implementation of well-
established intervention programs.
Question. Suicide--To what do you attribute rising suicide rates
among young people? What can we do about this?
Answer. In addition to a possible increase in the likelihood of
reporting youth suicides, the rising youth suicide rates have been
linked to increased substance use among the nation's youth. For
example, an association between lower state drinking age and higher
youth suicide rates has been shown.
So far there are no proven prevention efforts shown to reduce youth
suicide rates, and some school-based awareness programs have actually
caused distress in vulnerable youth. NIMH and NIDA just released a
program announcement encouraging researchers to submit applications
that test various approaches to preventing youth suicidal behavior.
Question. Dr. Hyman, can you tell us what you are doing to address
the legal and ethical issues that may interfere with the need to do
critical research on depression and suicide? Should people who are (or
who may be) suicidal be allowed to participate?
Answer. NIMH staff, and experts in (1) clinical research with
suicidal patients, (2) bioethics, and (3) legal issues pertaining to
liability risks with suicidal patients have developed a draft document,
Safety and Ethical Issues to Consider for Persons at High Risk for
Suicidal Behavior in Intervention Trials. Its purpose is to propose
ways to minimize risk and consider the ethical issues unique to
conducting research on suicidal behavior, in order to promote more
research on effective interventions to reduce suicidal behaviors.
Currently, the draft is being circulated to OPRR staff, representatives
from the National Advisory Mental Health Council, professional and lay
advocacy communities, Institutional Review Boards (IRB) and Data Safety
Monitoring Boards (DSMB) members, and former research participants, for
comment.
As the draft was being developed, the audience in mind included
researchers conducting clinical trials designed to reduce the rate of
suicidal behaviors, and the IRBs and DSMBs that must review and monitor
them. However, the document is also intended to be useful for
researchers conducting any type of treatment trials aimed at reducing
symptomatology in disorders known to carry a high risk for suicidal
behavior. The adequate incorporation of plans to increase safety,
minimize risk, and consider the ethical issues pertaining to
individuals who may become suicidal in treatment trials, could allow
more individuals who are at risk for becoming suicidal to participate
in a greater number of treatment trials.
national institute of neurological disorders and stroke
Question. Dr. Fischbach, your Institute recently undertook a major
effort to produce a five-year research plan for Parkinson's disease
research. How can this kind of initiative advance the research into
Parkinson's disease and should this kind of process be duplicated for
other disease research areas?
Answer. The Parkinson's disease research agenda proposes a
comprehensive approach--understanding the disease, developing
treatments, creating research capabilities, and enhancing the research
process. We are optimistic that such an approach will result in
significant progress against Parkinson's and other neurodegenerative
disorders. It may prove to be a good model for many diseases. We were
particularly pleased by the enthusiastic participation of leaders from
the Parkinson's research community, from other fields that can
contribute to the effort, and from the patient advocacy groups.
NINDS embarked on a strategic planning process last year, and we
continue to refine it in terms of next steps and procedures for
implementation. The strategic plan is based on broad, cross-cutting
themes (such as neurodegeneration), each one of which touches on many
disorders. The plan has already produced many initiatives that address
both basic neuroscience and specific disease problems. We plan to
complement this approach with additional plans focused on specific
disorders, and began with Parkinson's disease. Using a slightly
different approach, we are collaborating with the National Cancer
Institute to develop a plan for brain tumor research. We plan to
proceed with other disease-specific plans at the rate of two or three
per year.
Our view is that there are several useful models that can be
employed (including the more traditional but highly effective approach
of sponsoring workshops), depending on specific disease issues and the
state of the science. In general, however, we do not favor the
inclusion of funding proposals in long-range plans. We are concerned
that a proliferation of such budget-oriented plans would decrease our
ability to take advantage of new, unexpected opportunities, both in
terms of the specific disease being reviewed and more broadly in other
disease areas of interest.
consensus conference on osteoporosis
Question. Dr. Katz, I understand that a Consensus Development
Conference on Osteoporosis will be held at the NIH. What are the
specific issues that this conference will examine?
Answer. NIH held a Consensus Development Conference on Osteoporosis
Prevention, Diagnosis, and Therapy on March 27-29, 2000. The NIAMS was
the primary organizer of this conference. Fellow sponsors included the
NIH Office of Medical Applications of Research, nine other NIH
Institutes and Offices, and the Agency for Healthcare Research and
Quality. Well over 1,000 people attended presentations during the 3-day
conference.
Osteoporosis occurs in all populations and at all ages. About 10
million people in the United States have osteoporosis, and an
additional 18 million individuals are at increased risk for the
disorder.
The consensus panel was charged with addressing the following five
questions: (1) What is osteoporosis and what are its consequences? (2)
How do risks vary among different segments of the population? (3) What
factors are involved in building and maintaining skeletal health
throughout life? (4) What is the optimal evaluation and treatment of
osteoporosis and fractures? (5) What are the directions for future
research?
In general, the panel found that nutrition, exercise, and medicines
can play important roles in the prevention and treatment of
osteoporosis. The panel noted that maintaining optimal bone health is a
lifelong process that should begin in childhood. Bone mass attained
during childhood is perhaps the most important determinant of life-long
skeletal health. At all ages, physical activity and good nutrition,
particularly adequate calcium and vitamin intakes, aid in developing
and maintaining strong bones. Exercise can also reduce the risk of
falls, a major cause of fractures in people with osteoporosis.
While hormone replacement therapy remains a common treatment and
prevention option; the panel suggested that more information is needed
as to how estrogen reduces the incidence of fractures. There are new
medicines for preventing and treating osteoporosis, such as
bisphosphonates and selective estrogen receptor modulators. New
technologies have improved the detection of loss of bone mineral, a key
predictor of osteoporotic fracture, although the panel recognized that
no standard exists for comparing different screening devices.
The panel's recommendations for future research included
identifying and intervening in disorders that can impede the
achievement of peak bone mass in children of ethnic diversity;
improving diagnosis and treatment of secondary causes of osteoporosis,
such as that resulting from the use of glucocorticoids (for example,
prednisone); collecting data necessary to establish testing guidelines
for osteoporosis; developing quality-of-life measurement tools that
incorporate gender, age, and race/ethnicity; conducting randomized
clinical trials of combination therapies to prevent or treat
osteoporosis; and developing a paradigm for the management of
fractures.
screening and treating osteoporosis
Question. Do we have good screening mechanisms for osteoporosis?
And once we diagnose an individual with osteoporosis are there adequate
treatment protocols?
Answer. Fortunately, research over the last decade has led to some
very reliable methods for assessing bone mass/bone mineral density.
Dual energy x-ray absorptiometry (DXA) has been developed and used in
some large studies that confirm the association of low bone mineral
density with high fracture risk. This technology can assess the bone
mineral density of two important sites of fracture in the body--the hip
and the spine. The results of this test can be used to identify
individuals at high risk of fracture who may profit from interventions
designed to slow bone loss.
There are several medications available to treat osteoporosis.
Estrogen has the longest history in the prevention/treatment of
osteoporosis. Two newer medications called bisphosphonates are approved
by the FDA for osteoporosis--alendronate and risedronate. These
medications are bone-specific and have been shown to reduce fractures
in clinical trials. Another approach to osteoporosis has been the
development of Selective Estrogen Receptor Modulators (SERMs). These
drugs mimic the positive effects of estrogen in the bone but have been
modified to diminish some of the deleterious effects of estrogen on the
breast and the uterus. Currently, there is one SERM that has been
approved by the FDA for osteoporosis--raloxifene. However, this is an
active area of research. NIH is sponsoring a workshop on Selective
Estrogen Receptor Modulators April 26-28, 2000, to develop a research
agenda in this important area.
osteogenesis imperfecta
Question. I understand that in 1999 you supported a workshop on the
development of new strategies for Osteogenesis Imperfecta, also known
as brittle bone diseases. Can you summarize the outcome of that
workshop? And please tell us how your 2001 budget reflects these
recommendations?
Answer. In September of 1999 the NIAMS partnered with the
Osteogenesis Imperfecta Foundation, the Children's Brittle Bone
Foundation, and the NIH Office of Rare Diseases to sponsor a meeting on
Osteogenesis Imperfecta (OI). The goal was to stimulate new clinical
approaches to OI by calling attention to recent findings in several
areas of basic biology and model systems. These areas include stem cell
manipulation and gene therapy strategies, cell-matrix interactions, and
the role of growth factors and cytokines in bone turnover. The workshop
also assessed recent advances toward the ultimate goal of developing
techniques for correcting the underlying genetic defects in OI. In
addition, recent observations suggest that the metabolic consequences
of collagen defects, such as effects on the activities of osteoblasts
and osteoclasts, play an important role in the pathogenesis of OI.
Exploring these new findings could lead to therapeutic approaches, such
as pharmacological interventions, that could have an significant impact
on the clinical management of OI. A number of research recommendations
resulted from the workshop, and the NIAMS is currently assessing future
research directions.
The opportunities for basic research advances to move the field
forward seem to be particularly promising. NIAMS is planning an
initiative in fiscal year 2001 to capitalize on the opportunity to
better understand how the bone cells in patients with osteogenesis
imperfecta are programmed and can be re-programmed by therapeutic
intervention.
osteoporosis
Question. With the aging of the population is osteoporosis becoming
a problem for men, as well as women? And if so, do you recommend that
men over 65 take advantage of bone density screening?
Answer. Although American women are four times as likely to develop
osteoporosis as men, an estimated one-third of hip fractures worldwide
occur in men. Studies have shown that men tend to develop osteoporosis
about 10 years later in life than women. This difference has been
attributed to a higher peak bone mass in men at maturity and to a more
gradual reduction in sex steroid influence in aging men. The lifetime
risk of older men for fractures of the hip, spine, or wrist is
considerable, and the Institute is committed to providing a particular
focus on osteoporosis in men, in addition to its extensive portfolio of
research on osteoporosis in women. In fiscal year 1999, the NIAMS
launched a major study of osteoporosis in men. This is a 7-year study
that will enroll and then follow 5,700 men 65 years and older for an
average of 4 to 5 years, and will determine the extent to which the
risk of fracture in men is related to bone mass and structure,
biochemistry, lifestyle, tendency to fall, and other factors. The
study, which is supported in part by the National Institute on Aging
and the National Cancer Institute, will also try to determine if bone
mass is associated with an increased risk of prostate cancer.
As mentioned above, men tend to develop osteoporosis somewhat later
than women. It is not clear that it would be advantageous to screen all
men over 65. Rather physicians should be aware of some of the factors
that place men at high risk of an osteoporotic fracture such as
previous low impact fractures, especially spine fractures that may be
manifest by a loss of height, the use of certain drugs like prednisone,
and the diagnosis of primary hyperthyroidism. In addition, low body
weight and diseases that lead to malabsorption of food, or a family
history of low impact fractures, may raise suspicion of low bone mass.
medicare and osteoporosis
Question. Given the aging of our population, do you see the
problems of treating bone diseases, which is paid for by the Medicare
program, as one that will consume a large portion of the Medicare money
in the next 20 years?
Answer. The aging of the American population will certainly add to
the number of individuals at risk of fractures. It is estimated that
one out of two women will develop an osteoporotic fracture in her
lifetime. Men have a lower risk but are increasingly living to an age
when their fracture risk is also high. Serious efforts at the
prevention of bone loss need to be directed to reducing the number of
individuals affected. Efforts directed at the young can be particularly
important as the development of an adequate bone mass at maturity is
important protection against fractures later in life. These efforts
need to be focused on increasing physical activity, maintaining a
healthy body weight and adequate calcium intake. The recent Consensus
Development Conference on Osteoporosis estimated that only about 25
percent of boys and 10 percent of girls ages 9 to 17 meet the calcium
intake recommendations of the Institute of Medicine.
However, the seniors of the next few decades are already adults and
there is a great deal that can be done to prevent bone loss in adults.
In fact, some of the same preventive measures that are effective in
building bone mass in adolescence are effective in maintaining bone
mass later in life. Low physical activity in older populations is a
significant factor in bone loss but also affects the balance and
coordination that protect against falls. Active seniors have fewer
falls and less serious ones. Calcium and vitamin D can also prevent
bone loss, and their intake in senior adults are seriously below the
recommended levels. In some individuals at high risk of fracture,
medications directed to slowing bone loss can be a cost-effective
strategy.
osteoporosis
Question. If the treatment of bone diseases is going to be a major
expense to the Medicare program, do you think you and your fellow
institute directors are investing enough money in bone research in
order to improve the quality of life for our seniors and to reduce the
cost to Medicare?
Answer. I am pleased to tell you that bone research is indeed a
major priority for the NIH. A number of NIH components plus
representatives from other agencies participate in the Federal Working
Group on Bone Diseases--a collaboration that helps to coordinate
research activities across the Federal government and provide
recommendations for future research efforts. NIAMS supports bone
research across the full spectrum from basic studies on how bone is
normally built up and how bone breaks down in disease to clinical
studies to improve our diagnostic and therapeutic abilities; and to
prevention studies, especially those that target young people in their
prime years for building strong bones. We also support major clinical
trials that are looking at the value of combining some of the available
drugs for treating osteoporosis, to determine the enhanced value that
combinations of drugs may have against osteoporosis. In addition, we
have recently supported a Consensus Development Conference at the NIH
on osteoporosis, and experts identified a number of promising avenues
for the NIH to consider and pursue. Finally, in the area of information
dissemination, the NIAMS and other ICs fund the NIH Osteoporosis and
Related Bone Diseases National Resource Center that provides
comprehensive and timely information to patients, their families, and
their health care providers. While there are always opportunities for
funding additional research, I believe that the NIH research efforts in
bone--those already underway as well as those planned for the future--
reflect the major priority we give to this area of research.
muscular dystrophy
Question. Why has NIAMS been unable to provide as many muscular
dystrophy related single investigator grants as other institutes?
Answer. The NIAMS, together with the National Institute of
Neurological Disorders and Stroke (NINDS), considers research on the
muscular dystrophies to be a priority area. We will continue to work
with the extramural muscular dystrophy research community, as well as
interested patient organizations, to stimulate and support promising
studies in this area. In fiscal year 1999, the NIAMS invested nearly
$5.4 million in muscular dystrophy projects, an increase of over 40
percent from the previous fiscal year.
A number of exciting studies with implications for our
understanding of the muscular dystrophies have been supported by the
NIAMS in recent years. One such investigation used gene therapy to
restore muscle function in a hamster model of limb-girdle muscular
dystrophy (LGMD). In another NIAMS-funded study, researchers
successfully used the common antibiotic gentamicin to restore the
function of the gene that encodes for the protein dystrophin in mouse
models of Duchenne muscular dystrophy (DMD). In a third project, NIAMS-
supported researchers used gene therapy in mice to give the body a
boost in fighting the effects of aging on muscle, and to help repair
the damage caused by injury and muscle-wasting disorders such as
muscular dystrophy. These projects underscore the potential of treating
human forms of LGMD, DMD and other muscular dystrophies with gene
therapy approaches.
Another area of excitement relates to a new protocol developed with
support from the NIAMS that makes it possible to obtain an almost
unlimited number of a special class of adult stem cells from a small
sample of bone marrow. These adult stem cells have the ability to
develop into cells of muscle, nerve, bone, cartilage and fat. Because
of their vast potential for differentiation, they may be excellent
therapy vectors for a number of skeletal diseases, including muscular
dystrophy.
Next month, the NIAMS--in partnership with the NINDS and the NIH
Office of Rare Diseases--will support two research meetings on muscular
dystrophy. The first is an international scientific conference centered
on clinical and molecular studies of facioscapulohumeral dystrophy
(FSHD). The meeting will bring together researchers who are already
involved in FSHD projects, as well as scientists who are working in
related fields and may be able to contribute to progress on FSHD. The
second meeting will focus on therapeutic approaches for DMD. This
workshop is aimed at addressing key questions in improving treatments
for DMD, identifying areas of needed scientific knowledge, and the
critical next steps to promote effective therapy. The NIH expects to
build on the insights from these two meetings to develop new program
initiatives related to the muscular dystrophies. Such initiatives would
complement on-going efforts to stimulate research in this area,
including the currently active program announcement on the pathogenesis
and therapies of the muscular dystrophies.
Question. Why is there no separate study section for muscle
biology? Would a separate study section enhance research and integrate
efforts?
Answer. The NIH Center for Scientific Review (CSR), which conducts
the peer review process, is currently involved in a comprehensive
assessment of its study section structure, led by Dr. Bruce Alberts,
the President of the National Academy of Sciences. The purpose of this
assessment is to ensure that CSR provides a rigorous, unbiased review
system that facilitates the advance of all areas of biomedical
research, including muscle biology. Indeed, muscle disease review
issues are being considered as part of the assessment. CSR will also be
meeting with scientists at the Duchenne muscular dystrophy workshop in
May to discuss this and other review concerns. The outcome of these
discussions will help guide future decisions about the review of
muscle-related research grant applications.
There is no simple answer to the question of whether a dedicated
study section would enhance the success of muscular dystrophy research
applications or otherwise improve coordination of muscle-related
research. It is important to consider that the NIH receives a broad
range of research applications on muscle functioning and disease, and
diverse areas of scientific expertise are required to review those
applications. Whether it is desirable--or, indeed, even feasible--to
cluster all muscle research proposals into a single study section is
one of the questions being explored by the CSR assessment described
above.
magnetic therapy
Question. Has the use of magnets been proven scientifically?
Answer. Todate, there have been only a few, rigorous, double-
blinded, randomized trials investigating the efficacy of magnet therapy
(e.g. Vallbona et al., 1997, Weintraub, 1998; Taylor et al, In press).
Although the results of these trials suggest that magnet therapy is
more effective than placebo for pain management, a definitive statement
on magnet therapy's efficacy awaits completion of a large, multi-site
randomized controlled trial. The research portfolio of the National
Center for Complementary and Alternative Medicine (NCCAM) includes
rigorous studies of magnet therapy.
Question. Are there any dangers in using magnets like sleeping on a
magnetic pad or magnets in your shoes? I heard somewhere that they are
not recommended for people with heart problems--they cause problems
with electrical currents.
Answer. Static magnetic fields appear to be safe. In 1987, the
World Health Organization reported that ``the available evidence
indicates the absence of any adverse effects on human health due to
exposure to static magnetic fields up to two Tesla.'' Given that the
typical static magnet used to treat disease produces a magnetic field
of only a few thousands of a Tesla in strength, there is little
intrinsic danger to using magnet therapy. Supporting this contention,
the few well-designed clinical trials investigating static magnets have
not reported any severe adverse events associated wit the intervention
(e.g. Vallbona et al., 1997, Weintraub, 1998; Taylor et al, In press).
Although no cause and effect was established, there has been one case
report of a person who developed a myeloma after sleeping on a magnetic
mattress for five years (Burns 1994). Concerning the use of static
magnets by individuals with heart disease, there is conflict evidence
whether low level electromagnetic fields produce changes in heart rate
(Cook et al., 1994; Korpinen and Partanen, 1994) and blood pressure
(Korpinen and Partanen, 1996). Until these issues are addressed for
static magnetic fields, caution might be suggested for individuals
suffering from severe hypertension. Caution may also be advised for
individuals with cardiac pacemakers or wearing cardiac infusion pumps.
______
Questions Submitted by Senator Thad Cochran
infectious disease
Question. The NIH has invested heavily in infectious disease
research. We have done a good job of developing vaccines to combat many
infectious diseases, including HIV. However, one area that is of
concern to me is that of drug resistance in infectious diseases. We now
have bacteria that are becoming resistant to our last lines of
antibiotic treatment.
What is the NIH doing to insure appropriate use of antibiotics?
What is the NIH doing to stimulate the development of new antibiotics
to combat drug resistant bacteria?
Answer. The NIH co-chairs with the Food and Drug Administration
(FDA) and the Centers for Disease Control and Prevention (CDC) an
Interagency Task Force on Antimicrobial Resistance. The initial public
activities of this Task Force were announced in the Federal Register,
Vol. 64, No. 123, Monday, June 28, 1999. This was in conjunction with a
July 1999 public meeting organized by ten Federal agencies (the CDC,
the FDA, the NIH, the Health Care Financing Administration, the Health
Resources and Services Administration, the Agency for Health Care
Research and Quality, the Environmental Protection Agency, the
Department of Defense, the U.S. Department of Agriculture, and the
Department of Veterans' Affairs) to coordinate Federal programs
relating to antimicrobial resistance. The purpose stated in the
preceding notice was ``To solicit input from invited consultants
regarding items to be included in a Public Health Action Plan that,
when published, will serve as a blueprint for activities of Federal
agencies to combat antimicrobial resistance. The Plan is being
developed by a Task Force composed of Federal personnel from several
Federal agencies and departments, co-chaired by the CDC, the FDA, and
the NIH.'' It should also be noted that the fiscal year 2000
appropriations report language for CDC mentions this existing Task
Force and the recommendation that a report be done within a year of
enactment of the legislation--the above mentioned Public Health Action
Plan is in response to this report language. Accordingly, four focus
areas were selected for grouping the discussions and outcome:
Surveillance, Prevention and Control, Research, and Product
Development. The issue of appropriate use of antimicrobials, including
antibiotics, is within the purview of Prevention and Control, and is
addressed in the connotation of ``judicious use.'' The NIH is
collaborating in the overall development of the Action Plan in the role
of Co-Chair, and also plans to collaborate with the appropriate
agencies coordinating any resulting actions relating to judicious use
of antimicrobials, principally the CDC and the FDA, for any action
items that fall within the scope of the NIH mission.
The NIH funds a diverse portfolio of grants and contracts to study
antimicrobial resistance in major viral, bacterial, fungal, and
parasitic pathogens. The National Institute of Allergy and Infectious
Disease (NIAID) has a lead role in many of these activities, but
numerous other Institutes and Centers at the NIH also support and
participate in research related to antibiotic resistance.
The NIH-funded projects include basic research on the disease-
causing mechanisms of pathogens, host-pathogen interactions, and the
molecular mechanisms responsible for drug resistance, as well as
applied research to develop and evaluate new or improved products for
disease diagnosis, intervention, and prevention. Numerous genome
projects seek to identify new gene targets for the development of drugs
and vaccines. Other NIH-sponsored activities with relevance to
antimicrobial resistance include physician and researcher training and
education. In addition, the NIAID supports a number of clinical trials
networks with the capacity to assess new antimicrobials and vaccines
with relevance to drug-resistant infections. Among these are the AIDS
Clinical Trials Groups, the Mycoses Study Group, the Collaborative
Antiviral Study Group, the Vaccine and Treatment Evaluation Units, and
the Tuberculosis Research Unit. The NIAID supports contracts that
screen for novel anti-tuberculosis drugs by testing in vitro and in
animal models. The candidate drugs are selected for screening from
submissions by academic and private sector researchers worldwide and
from the National Cancer Institute's (NCI) chemical repository.
With regard to other NIAID-specific projects, the Institute funds a
diverse portfolio of grants examining antimicrobial resistance among
the major nosocomial bacterial pathogens, for example, multi-drug
resistant Staphylococcus aureus, enterococci, and Escherishia coli.
Current research support is aimed at:
--Identifying new diagnostic techniques, novel therapeutics, and
preventive measures to minimize infection with resistant
pathogens, prevent the acquisition of resistance traits, and
control the spread of resistance factors and resistant
pathogens in hospital settings;
--Understanding the molecular biology and genetics of resistance gene
acquisition, maintenance, and transmission;
--Exploring novel approaches to combat resistance through passive or
active immunization;
--Identifying natural antimicrobial peptides that may prove useful as
new classes of antibiotic-like drugs; and
--Through the use of molecular characterization, continuing efforts
to determine the degree of spread of multi-resistant
international clones of Streptococcus pneumoniae in the United
States and the rest of the world.
The NIAID is also creating a Bacteriology and Mycology Study Group
to design and conduct multi-center clinical studies of interventions
for serious fungal and healthcare-associated resistant bacterial
infections. Key aspects of the effort will be to: formulate and
implement a scientific research agenda; establish a multi-center
clinical studies group; establish a clinical studies coordinating unit;
provide leadership and organization of the study group; and conduct,
complete, and report the results of the clinical studies. This project
will be funded in the spring of 2001.
Finally, the NIAID recently released a Request for Applications
(RFA), ``Challenge Grants: Joint Ventures in Biomedicine and
Biotechnology.'' The purpose of this initiative is to support research
and development efforts whose outcomes could significantly reduce the
impact of infectious diseases nationally and worldwide. The RFA was
issued in response to the fiscal year 2000 Public Health and Social
Services Emergency Fund appropriation of $20,000,000 designated for
``NIH Challenge Grants and Partnerships.'' This new initiative is
intended ``to promote joint ventures between the National Institutes of
Health and the biotechnology, pharmaceutical, and medical device
industries'' and involves a ``one-on-one matching of federal dollars by
qualified organizations that are conducting R&D activities in
biomedical research or biotechnology with commercializable potential or
conducting research in promising therapies.''
The NIAID has identified areas of high importance where it believes
successful product research and development combined with existing
infrastructures and federal challenge grant funding could significantly
impact a major health or medical problem. Bacterial drug resistance is
an evident area of focus in this solicitation in two specific areas:
tuberculosis (TB), and emerging and resistant infections, including
drug resistant staphylococci and enterococci.
It is the intention of these challenge grants to encourage the
private sector to develop new TB drugs, including: identification of
potential new drug targets and novel classes of drugs (making use,
where appropriate, of the Mycobacterium tuberculosis genome sequence
and high throughput approaches); preclinical development of novel
classes of drugs and optimization of lead compounds; and clinical
testing of potential new therapies. The NIAID also seeks to encourage
the private sector to increase its commitment to TB vaccine development
through these challenge grants. In particular, it encourages the use of
whole genome approaches for the identification of promising protective
antigens, and the development of both pre-exposure and post-infection
candidate vaccines from pre-clinical through clinical testing.
Similarly, through the challenge grants mechanism, the NIAID seeks
to interest the private sector in pursuing preclinical and clinical
studies of passive or active immunization candidates to protect against
resistant staphylococcal infection, first in the most vulnerable
populations such as severely-ill hospitalized patients and patients
facing major surgery and at risk for infection, and then also for
potentially broader application to community situations. Novel
therapies, such as bacteriophage therapy, will be considered as
candidates for study for enterococci.
parkinson's disease
Question. The committee just received the Parkinson's Disease
Research Agenda from your office.
Do you agree with the report that a cure for Parkinson's is now a
comprehensive goal if a comprehensive approach is pursued?
Answer. A cure for Parkinson's is a realistic goal, given what is
known about the disease and the research tools now available to us. The
research agenda proposes a comprehensive approach--understanding the
disease, developing treatments, creating research capabilities, and
enhancing the research process. We are optimistic that such an approach
will result in significant progress against Parkinson's and other
neurodegenerative disorders.
Question. Is the NINDS sufficiently staffed to implement such a
plan?
Answer. The plan reflects our best professional judgment as to what
could be accomplished if funding were available to implement all
aspects of the research agenda, but without taking into account fiscal
constraints or other competing priorities of NIH and the rest of the
Federal government. In order to do this, more staff would be required
to develop the necessary initiatives and work collaboratively with the
research and patient communities.
diabetes
Question. One of NIH's initiatives for 2001 deals with genetics
research and exploiting genomic discoveries. One area where genetics
research could be essential is in the area of diabetes, especially
juvenile diabetes.
Do genomic discoveries show promise in the area of juvenile
diabetes and is funding sufficient to do this?
Answer. Type 1 diabetes has a strong genetic determinant, in which
more than one gene is believed to play a role. These genes make some
individuals more susceptible to developing diabetes than others. In
addition, genetic factors may cause some individuals with diabetes to
be more prone to developing the serious and life-threatening
complications associated with type 1 diabetes. Knowledge of the genetic
defects underlying diabetes will be critical not only for identifying
individuals at risk for diabetes and its complications, but also for
identifying targets for effective treatment and prevention.
The NIDDK is attempting to provide cutting-edge genetics and
genomics resources to our investigators. We have already begun to move
in this direction, with a biotechnology initiative on microarray
technology that will be useful to diabetes researchers and other NIDDK
investigators, and with a major effort planned for a Diabetes Genome
Anatomy Project (DGAP) to locate and analyze the function of genes in
all the various types of tissue relevant to diabetes. Start up of the
DGAP initiative is currently slated for fiscal year 2001.
The NIDDK envisions DGAP as a trans-NIH effort involving several
Institutes with a research interest in diabetes and its complications.
This project would collect genomic information on the spectrum of genes
expressed in all tissues relevant to diabetes and its complications. It
would build upon an ongoing NIDDK initiative on the functional genomics
of the developing pancreas. While our ongoing effort supports the
production and sequencing of complementary DNA libraries based on
multiple stages of pancreatic development, the DGAP would be much
broader. Objectives would be to obtain full length cDNAs from tissues
relevant to diabetes; to discover novel genes in tissues affected by
diabetes; to conduct expression profiling to determine patterns of gene
expression in disease; and to perform functional phenotyping of
expressed products in tissues affected by diabetes. More importantly,
this initiative--if undertaken at a full-scale level--would allow for
the cataloging of all information obtained in a diabetes relational
database with automated data mining and query support. This database
would be developed and offered as a resource for all diabetes
investigators and could be used in the development of new assays,
identification of potential therapeutic agents, and points of departure
for new studies into diabetes and its complications. Information
obtained through an initiative such as this has the potential to
further our understanding of the causes and mechanisms of diabetes, to
identify targets for effective treatment and prevention, and to serve
as a springboard for the development of future investigator-initiated,
hypothesis-driven research. The degree to which we can undertake all
components of this initiative and the timeline for implementation will
be dependent on resource availability.
______
Questions Submitted by Senator Tom Harkin
mental health research
Question. In several recent Mental Health Advisory Council reports
you have recommended improving the relevance of prevention research
into early interventions, clinical research to actual practice, and of
behavioral research to serious mental illnesses. Could you please
discuss some of the difficulties you've encountered in your efforts to
change the institute's course toward the greatest public health needs?
Where does NIMH stand relative to other NIH institutes on the rate of
grants submitted and funded? Is the relative quality of the science in
the grant submissions and proposals received NIMH rising or declining?
Answer. Mental disorders and suicide together account for over 15
percent of the burden of disease in established market economies such
as the United States. The mission of the National Institute of Mental
Health is to reduce the burden of mental disorders. NIMH also takes the
lead in understanding the impact of behavior on HIV transmission and
pathogenesis, and in developing effective behavior preventive
interventions in areas such as violence. These collectively constitute
an enormous area of responsibility. Over the past several years, NIMH
has systematically examined its overall research portfolio and
conducted even more in-depth reviews of selected programs, areas of
science, and disorders, all with the objective of refocusing programs
to bring the best science to bear on areas of greatest disease burden:
depression; schizophrenia, bipolar disorder, obsessive compulsive
disorder, and childhood autism, to name a few. In particular we have
tried to ensure that knowledge gained is relevant to the full range of
patients: from children to the aged; both sexes; all genders, races,
ethnic groups; and to individuals with co-occurring conditions. This
refocusing process has encountered significant challenges. One has been
the need for extensive reorganization of programs within the
Institute's intramural and extramural research programs. On the
intramural side, certain laboratories and clinical units have been
phased down or terminated in order to permit new growth and
initiatives. Extramural staff and program realignments have been even
more extensive and, often, difficult. It also has been quite
challenging to shift the direction of the larger extramural community--
for example, to motivate basic behavioral researchers to examine and
revise many time-tested research paradigms in order to make research
more relevant to clinical questions, or to encourage investigators to
take a potentially risky step outside a given area of expertise into
uncharted areas such as translational research. Although we have
encountered some resistance and doubts about the need for change, these
efforts are paying off.
Since we rejoined the NIH in 1993, the ratio between competing
research project grant applications submitted and awards funded, or
success rates, has been consistently lower by 3-5 percent from the
aggregated average for all NIH Institutes and Centers. The functional
consequence of this differential for scientists is that an application
for funding to the NIMH had a 16 percent lower chance of success than
for NIH in the aggregate. This was also true for the most recent 1999
fiscal year when the success rate for NIMH was 27 percent in comparison
to the aggregate NIH success rate of 32 percent. Most NIMH applications
are reviewed in committees with applications from several different NIH
Institutes, and NIMH applications have been consistently judged
somewhat better than average by those committees.
Although precise data is not available, it is my opinion that since
joining NIH, NIMH science is stronger than it has ever been. The
science has been kept sharp by strong competition within NIH review
committees and the new seriousness of scientific review within the
intramural research program. As indicated in the paragraph above, NIMH
scientists have performed well in review comparisons with scientists of
other institutes.
research on children's mental health disorders
Question. As I understand it, research on children's mental
disorders at NIMH still lags behind so much other research, with few
treatments available that work for obsessive-compulsive disorder (which
often begins in childhood) and bipolar disorder (which increasingly is
seen as beginning in childhood and adolescence). What is NIMH's plan
for strengthening this research and assuring the development of more
effective treatments for children?
Answer. NIMH is actively planning a series of projects. A new
program announcement is being crafted that will focus specifically on
children with serious mental illnesses, including obsessive-compulsive
disorders, bipolar disorders, eating disorders, schizophrenia, among
others. The object of the announcement is to encourage a broad range of
studies on the onset, course, risk processes, and treatments for
serious mental illnesses in children and associated disabling
impairments. In addition, next week NIMH is hosting a meeting to
identify key research gaps in identification and treatments for
children with bipolar illnesses, with the aim to further advance
studies in these areas. Also, NIMH is currently supporting seven
Research Units of Pediatric Psychopharmacology, several of which focus
on bipolar illnesses in children.
research on minority mental health
Question. The landmark 1998 Schizophrenia PORT study, found that
the gap between science and accessible treatment has never been wider.
Moreover, this lack of ``translation'' was at its worst in the African
American community, leading to significant health disparities. African
Americans with schizophrenia were more likely to experience
overmedication with anti-psychotic medications, increased side-effects,
and under-treatment of depression to a higher degree than other racial/
ethnic groups. What is NIMH doing to improve the translation of
scientific advances into real world treatment, in general, and
especially in the African American community?
Answer. Since the completion of the Schizophrenia PORT study, NIMH
has funded additional studies to look, in depth, into reasons for the
disparities in treatment. One study is designed to determine if
adherence to treatment recommendations will lead to improved outcomes
and whether minority status has an impact on what treatments are
provided. In addition, the NIMH has issued a report, Bridging Science
and Service, that calls for more research on improving the delivery of
treatments in community populations, especially those who are
traditionally underserved. NIMH also recently launched four new major
clinical treatment studies that will provide data on how to treat some
of the most severe mental illnesses in real-world settings. These
studies are required to include minority populations so the results
will be relevant to them.
Currently, the NIMH Committee on Health Disparities is drafting a
document delineating the specific research priorities for the next 5
years. The report will focus on what the state of disparities is; why
they exist and approaches to remedy the situation. In addition, the
National Advisory Mental Health Council just issued a new report,
Translating Behavioral Science into Action, which calls for research
that takes into account the importance of individual, sociocultural,
and organizational factors on the differences in help seeking,
treatment, and outcomes from treatment.
In the past, studies of treatment in schizophrenia tended to be
small scale, industry sponsored, and focused on safety and short term
efficacy. The data gathered were useful in obtaining regulatory (FDA)
approval, but provided little guidance for practitioners on how best to
treat patients in the community. Moreover, for a number of reasons,
African Americans tended to be underrepresented in these treatment
trials. The net result was that clinicians had to base many treatment
decisions, particularly in minority patients, on prior experience,
opinion, and their own experiences, rather than objective data. To
remedy this situation, NIMH recently initiated a multie-year, multi-
site, multi-million dollar project to study new antipsychotic drugs in
people with schizophrenia (Clinical Antipsychotic Trials of
Intervention Effectiveness, CATIE). One of the project's highest
priorities is to include a representative sampling of patients with
adequate representation of minorities and not be limited to middle
class or upper class patients. There will be considerable outreach
efforts to African Americans with schizophrenia, including recruitment
of study sites in African American communities. Important
characteristics of the trial are that all subjects participating in the
trial will receive state-of-the-art care, and clinicians involved in
the trial will be guided on best clinical practice and will have world-
class experts available for consultation. While the number of patients
treated in this trial will represent an insignificant fraction of the
totality of people with schizophrenia, NIMH anticipates that the
experience with patients and clinicians in African American communities
gained through CATIE will greatly facilitate subsequent translation of
CATIE's findings into that community as well as aid in dissemination of
optimal clinical practices to mental health professionals providing
care to African American people with schizophrenia.
nimh research agenda
Question. A recent National Advisory Mental Health Council report
notes that the behavioral science portfolio at NIMH has not been well-
focussed on the areas of greatest public health need and makes a number
of recommendations to improve the relevance of this portfolio. Could
you discuss some of the factors which contributed to this lack of
attention to many of our serious mental illnesses, what you think
behavioral research can contribute, and how you can redirect existing
research resources to develop more relevant behavioral research?
Answer. Until recently, NIMH has focused relatively little
organized effort to bridge basic behavioral science and severe mental
illness. In part this has reflected the Institute's encouragement of
investigator-initiated research, which, in turn, reflects academic
traditions within psychiatry and psychology that often place a higher
value on basic research than on clinically oriented (or applied)
research. In addition, clinical and basic behavioral scientists have
traditionally operated in separate academic departments unfamiliar with
the language, concepts and problems of each other's disciplines.
Because clinical populations have not been accessible to basic
researchers, they have often focused on normal or less ill populations.
Academic incentive systems and the segmentation of funding and outlets
for publication have not promoted cross-disciplinary studies. Training
programs in basic behavioral science often discourage exposure to
clinical problems and clinical settings so that behavioral scientists
may be unaware of basic research issues and opportunities posed by
research on mental illness.
Finally, when NIMH has attempted to encourage targeted research
that can bridge between basic behavioral research and severe mental
illness, relatively few researchers have responded. This lack of
interest in certain types of behaviorally oriented translational
research indicates the necessity for more specific targeted efforts to
stimulate interest in these areas.
Basic behavioral science will contribute to understanding and
solving otherwise intractable public health problems related to serious
mental illness in a number of areas:
Understanding Symptoms of Illness
The symptoms of serious mental illness involve attention, abstract
thinking, social interaction, motivation, and emotion. Behavioral
science should offer new ways of assessing these behavioral processes
that will: (1) help link them to underlying neurobiologic processes;
(2) allow their evaluation as indicators of risk prior to the
development of full-blown illness; and (3) facilitate the objective
assessment of response to targeted treatment interventions.
Encouraging Behavior Change
Theory-driven behavior-change interventions are highly successful
in HIV/AIDS, yet remarkably, behavioral theory has rarely focused on
health behaviors related to serious mental illness. More than half of
all schizophrenia relapses can be attributed to lack of adherence with
treatment recommendations. The application of theory-based behavior-
change principles to the problem of adherence should result in
effective approaches to substantially reduce morbidity in schizophrenia
and other serious mental illness.
Improving Treatments
Learning theory should guide new treatment development for mental
illness as well as treatment dissemination. Despite advances in
psychopharmacology, patients with serious mental illness must learn
ways of adapting to deficits and disabilities; learning theory should
inform the development of new cognitive-behavioral interventions for
skills training and illness self-management. At the same time, because
research advances are very slow to influence everyday care, we need a
better understanding of physician and provider behavior as related to
the diffusion of innovations.
Encouraging Help-Seeking
Evidence indicates that delay in seeking treatment contributes to
morbidity at the onset of serious mental illnesses including major
depression, bipolar disorder and schizophrenia. Behavioral science
should contribute to our understanding of the psychological and social
processes, including the influence of social norms and stigma, that
impede timely symptom recognition and help-seeking for serious mental
illness.
Helping Families Cope with Mental Illness
Mental illness in a child or spouse can have a profound effect on
family relationships, which in turn influence both the ill individual
and other family members. Relationship research should explicate the
adaptive responses of families that influence treatment outcome for the
ill family member, including adherence to treatment recommendations. At
the same time, better ways of characterizing and alleviating the family
burden created by serious mental illness must be developed. The
presence and severity of symptoms alone cannot account for the
disabilities associated with mental illnesses. Behavioral science
should contribute to a better understanding of the multidimensional
nature of social, vocational and instrumental functioning to refine the
choice of rehabilitation interventions. It should also aid in
identifying the different treatment needs of individuals who are
grouped within a single diagnostic category.
Understanding the Inheritance of Mental Disorders
Evidence indicates that defining mental disorders in terms of
behavioral dimensions rather than specific diagnoses may more closely
approximate inherited phenotypes. Behavioral science may aid in finer
characterization and measurement of these behavioral phenotypes to
facilitate the linkage of behavioral diseases to specific sets of risk
genes.
``Translating Behavioral Science into Action,'' the report of the
National Advisory Mental Health Council's Behavioral Science Workgroup,
provides a wealth of specific recommendations for redirecting existing
research resources. Measures commenced or soon to begin include:
--A Request for Applications (RFA) with set-aside funds that focuses
on basic behavioral processes in mental illness is under
development to jump start cross-disciplinary collaborations
between basic behavioral researchers and clinical
investigators.
--Simultaneously, a new Program Announcement (PA) will outline a
trajectory of research support to include both developing and
mature translational research centers to provide an
infrastructure for new research, speed the translation of
findings, and encourage interaction across basic, clinical and
services research. These efforts will signal a serious and
ongoing commitment on the part of NIMH to apply behavioral
science methods to the problems of mental illness.
--An ancillary study PA encourages behavioral scientists to access
the patient populations and infrastructure developed as part of
the NIMH clinical trial initiatives.
--Workshops bringing together behavioral and clinical scientists have
been initiated in the areas of (1) adherence in serious mental
illness; (2) informed consent and clinical research; (3)
research ethics; and (4) integrating behavioral science with
public health.
--Staff have worked with current behavioral scientist grantees to
encourage redirection into areas more closely dealing with
mental disorders.
--Training activities are being examined to identify ways to overcome
barriers to cross-disciplinary training experiences that are
required to facilitate translational research.
schizophrenia
Question. Given the many changes underway at NIMH in terms of the
funding of clinical research and the clinical research centers, how are
you moving to assure that the research base studying schizophrenia is
strengthened and expanded?
Answer. NIMH is strengthening and expanding its research base with
regard to schizophrenia in the following ways: (1) initiating a large,
sustained effort in the area of clinical trials of typical and atypical
antipsychotics for treatment of schizophrenia, and supporting Centers
and other grants addressing a large number of schizophrenia treatment
issues; (2) bolstering our program for the Silvio O. Conte Centers for
the Neuroscience of Mental Disorders in the area of schizophrenia (2
Centers to date); (3) undertaking major, innovative new efforts to
investigate genetic contributions to schizophrenia; these efforts
include a centralized, international respository for genetic samples
and for services to genetics investigators; (4) funding a large number
of R01-type grants focused on the neurobiology of schizophrenia, using
methods such as brain imaging, electrophysiology,
electromagnetoencephalography, etc.; (5) funding an extensive portfolio
of basic neuroscience research relevant to schizophrenia and other
mental disorders, (6) initiating new epidemiological and other efforts
to understand non-genetic risk factors for schizophrenia and to
characterize, in more insightful ways, the very early stages of the
disorder; (7) continuing to support a large intramural research program
targeting a number of aspects of schizophrenia.
advocates on comittees
Question. NIMH was a leader in asking members of the general
public--often consumers with severe mental illnesses or their family
members--to serve on scientific peer review committees looking at
treatment research. As you know, there was a good deal of skepticism
about the wisdom of including non-scientists on the committees. Could
you provide us with your assessment of how that innovative project has
turned out?
Answer. Public participant reviewers have successfully served for a
year on the NIMH's service and interventions review committees. Public
reviewers included individuals who have suffered from mental disorders,
family members of those suffering from mental disorders, mental health
care policymakers, and mental health care providers. All committee
members were asked for their assessment of how well the process worked.
The most common feedback was that the inclusion of public reviewers was
useful and that the public reviewers had done an excellent job. The
public reviewers, many of whom experienced the committee process for
the first time, were impressed with the efforts of the committee
members and the serious and objective nature of the deliberations. NIMH
will continue to request feedback from all reviewers to help inform and
improve the process of public participation in its review meetings.
Future plans are to help public reviewers focus on the review issues
about which they can best contribute such as determining public health
importance and human protection issues, and to continue adding and
training new public reviewers to ensure a broad diversity of opinions
and experiences.
human subject protection
Question. NIMH has been dealing with ethical issues in research on
mental illnesses for a number of years and has instituted a new Mental
Health Advisory Council review process to examine human subjects
protections before grant approval. Has this new review process been
useful? Is it helpful to have non-scientists on the review panel?
Answer. The NIMH Human Subject Research Council Workgroup has been
in existence for a year and will meet next on May 3, 2000. It has
helped assure that applications considered for funding meet the highest
scientific and ethical standards, and that proper protections for human
research volunteers are in place. Having bioethicists and consumers on
this group has been particularly useful in considering research risks,
benefits, alternatives, and informed consent issues.
co-occurring disorders
Question. NIAAA's strategic plan hardly mentions the problem of co-
occurring disorders. What plans does NIAAA have to address co-occurring
disorders--and in particular, is the institute sponsoring any research
to help establish the most effective treatment approaches when
alcoholism and a mental disorder occur together?
Answer. The strategic plan of the National Institute on Alcohol
Abuse and Alcoholism (NIAAA) is a blueprint of the Institute's major
goals and objectives and the strategies for achieving them. Many
elements of this plan were developed with input from the National
Advisory Council, with significant input from scientists in alcohol-
related areas as well as other research areas. The plan also reflects
advice from a broad spectrum of sources--researchers, health care
providers, over 250 liaison organizations, policymakers, people
recovering from alcoholism and their families, and others. It is a
``live'' document that the Institute will be updating periodically.
While researchers interested in the causes of disease will differ on
whether studying the patient with co-occurring disease is a promising
research strategy, the NIAAA is addressing the issue of co-occurring
disorders throughout the strategic plan and the research portfolio.
Alcohol's effects on the human body are ubiquitous,both physically
and psychologically. For example, chronic alcohol use is associated
with a range of diseases, from liver damage to depression. In terms of
psychological comorbidity, the challenge for alcohol investigators is
to determine whether specific diseases occur regardless of alcoholism,
are the result of alcoholism, or contribute to the development of
alcoholism. Numerous studies in this regard are underway. For example,
topics of studies on depression range from delivery of services for
depressed substance abusers to observing the outcome of treating
depressed alcoholics for depression alone, alcoholism alone, or both
conditions. The Institute's research on co-occurring psychiatric
disorders also includes studies of alcoholics with post-traumatic
stress syndrome and bipolar disorder and clinical trials of alcoholics
with social phobia and depression. Neuroscience contributes vital
information to studies of treatment for alcoholism and co-occurring
disorders, since they identify the biological mechanisms that underlie
these conditions. The NIAAA conducts numerous neuroscience studies on
mental health, from research on alcoholism and schizophrenia to
research on development of alcohol use and abuse in adolescents with
attention-deficit hyperactivity disorder.
treatment options for dually diagnosed individuals
Question. Drug abuse and psychiatric disorders frequently occur
together and these ``dually-diagnosed'' individuals pose special
treatment problems. I understand that NIDA's ambitious Clinical Trials
Network will address this issue. Could you please review for us what
the existing research says about the most effective treatment
approaches for these dually-diagnosed individuals and discuss why these
approaches have generally not been adopted by the drug abuse and mental
health treatment communities?
Answer. Data from the Epidemiological Catchment Area Study showed
that 53 percent of individuals with substance use disorders met
criteria for one or more mental disorder, and that about one-third of
individuals who have a mental disorder also experience alcohol and
other drug abuse disorders in their life. In the National Comorbidity
Study, 47 percent of individuals with a past year substance use
disorder diagnosis had a comorbid mental disorder. Affective, anxiety,
personality and psychotic disorders were most commonly comorbid with
substance abuse or addiction disorders.
Among treatment-seeking substance abusers and addicts, psychiatric
comorbidity has been found to be commonplace. In a recent study in
Baltimore, psychiatric comorbidity was detected in 47 percent of heroin
addicts one month after stabilization on methadone. Antisocial
personality disorder (25 percent) and major depression (16 percent)
were the most common diagnoses. Psychiatric comorbidity was associated
with increased severity of drug use and severity of associated social
problems. In other studies increased psychiatric symptoms have been
associated with increased HIV risk behaviors.
Clinical studies have shown that people who have comorbid mental
and addictive disorders tend to have poorer treatment outcomes, to
relapse more frequently, and are less responsive to psychiatric
medications during continued use. Furthermore, studies have
demonstrated that treatment of a comorbid mental disorder with
appropriate psychiatric and drug addiction medications and
psychotherapy and drug addiction counseling is important to the
effective treatment of the addictive disorder and results in better
outcomes and reduced relapse rates.
Several studies have now shown that integrated treatment programs,
which combine mental health and substance abuse interventions, offer
much greater promise than the totally separate programmatic approaches
found in many communities. In addition to a comprehensive integration
of services, successful programs include assessment, assertive case
management, motivational interventions for patients who do not
recognize the need for substance abuse treatment, behavioral
interventions for those who are trying to attain or maintain
abstinence, family interventions, housing, rehabilitation, and
pharmacotherapy.
Since the late 1980's new models of treatment for the dually
diagnosed--with a primary aim of integrating services----have been
evolving. This integration is accomplished through the use of
multidisciplinary teams that include both mental health and substance
abuse professionals who are cross-trained. However, despite the
encouraging research findings regarding the effectiveness of integrated
treatment for this population, implementation continues to be slow
because of problems related to the organization and financing of
programs. Organizational guidelines have been developed for dual
diagnosis programs, but few large systems have successfully integrated
services.
It appears that more research needs to be done on the organization
and financing of integrated treatment programs (health services
research). In addition, many of the basic components of integrated
treatment (family psychoeducation; motivational interventions;
behavioral treatments for substance abuse; integrating
pharmacotherapies, etc.) are still being developed and refined.
Research is needed to address the effectiveness of the appropriate
combination of these components.
Of course, another major barrier to successful implementation of
this integrated approach is the lack of cross-training for health
substance abuse and mental health professionals.
In summary, research has informed us that it is important to
diagnose both substance abuse and mental disorders when they are
comorbid and provide fully effective treatments for both disorders.
Several studies have demonstrated the significant benefits of
integrated substance abuse and psychiatric services in the same
treatment setting rather than separate and parallel treatment. Benefits
included increased engagement and retention in treatment, decreased
addiction severity and decreased psychiatric symptomatology. For the
most psychiatrically severe patients, these integrated interventions
must include Assertive Community Outreach, which fosters continuous
engagement and re-engagement in treatment, provides crisis intervention
and other community-based services, and supports medication compliance
and attendance at both psychiatric and drug treatment services.
Research is continuing on the refinement of the components of treatment
services and their effectiveness in combination therapy.
NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN)
will also serve as a potential vehicle for treating dually diagnosed
patients. Since the CTN will be testing efficacious therapies in real
life settings with diverse patient populations, dually-diagnosed
patients will be included in some treatment protocols with appropriate
analyses of these patients conducted to improve the treatment strategy
even more. Additionally, the CTN will develop protocols to test
therapies specifically targeted to co-morbid patients. For example,
this may include using antidepressants as an adjunct to behavior
therapies for depressed drug addicts.
autoimmune disease
Question. What is the status of the NIH's report on autoimmune
disease research? What is the timing on submission of that report?
Answer. The Report of the NIH Autoimmune Diseases Coordinating
Committee summarizes recent basic and clinical research programs
supported by NIH and non-Federal organizations, highlighting
coordination and collaborative activities in ten thematic areas; recent
and ongoing activities of the NIH Autoimmune Diseases Coordinating
Committee; and emerging opportunities to improve treatment and develop
preventive approaches for autoimmune diseases. Twenty-two NIH
Institutes, Centers, and Offices; the U.S. Food and Drug
Administration; the Centers for Disease Control and Prevention; the
Veterans' Administration; and ten private organizations with an
interest in autoimmune diseases are represented on the Committee. The
research programs supported by these groups comprise a broad range of
basic, pre-clinical, and clinical endeavors addressing many different
diseases, organ systems, and aspects of autoimmune disease.
The Committee will submit the report to the Office of the Director,
NIH, for clearance and hopes to release the report in the very near
future.
Question. What is the total amount that NIH is spending for
research on all autoimmune diseases?
Answer. The NIH spent $393.2 million on autoimmune disease research
in fiscal year 1999, and expects to spend $434.6 million in fiscal year
2000, and $456.9 million in fiscal year 2001.
Question. What are some research initiatives NIH is funding to
develop better treatments for these diseases?
Answer. Autoimmune diseases are immune-mediated disorders in which
the immune system attacks the body's own tissues. Treatment of these
diseases depends largely on immunosuppressive agents that have many
side effects, for example, steroids and cytotoxic therapies. However,
more specific and less toxic immune therapies have shown efficacy in
animal studies. As highlighted below, the NIAID, in collaboration with
many other federal and private organizations, has developed new
programs to assist in moving these promising therapies to clinical
practice.
Immune Tolerance.--The induction of immune tolerance is a major
therapeutic goal for the treatment of many immune-mediated diseases, as
it will eliminate or reduce the life-long dependence of many patients
on costly and toxic immunosuppressive drugs. Tolerance induction
strategies seek to modify or block deleterious immune responses, such
as those responses that cause the body to attack its own organs and
tissues in autoimmune disorders, or the immune responses that result in
the rejection of transplanted organs, tissues, and cells. A number of
promising reagents for the induction of immune tolerance are being
developed and can now be tested in clinical trials.
In September 1998, the NIAID published a long-term plan, now
available on the web (http://www.niaid.nih.gov/publications/immune/
bookcover.htm) to accelerate research on immune tolerance, particularly
in the clinical setting. In September 1999, the NIAID, with co-
sponsorship of the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) and the Juvenile Diabetes Foundation
International (JDFI), established one of the major research programs
emanating from this plan, the Immune Tolerance Network (http://
paramount.bsd.uchicago.edu/frameset.html). Leading investigators from
more than 40 institutions in the U.S., Canada, Western Europe, and
Australia are participating in the design and evaluation of clinical
trials of tolerance induction therapies for autoimmune diseases, asthma
and allergic diseases, kidney transplantation, and islet
transplantation for type 1 diabetes. In the six months since the
inception of this major clinical research program, the Network has
initiated the development of clinical trials for a variety of immune-
mediated disorders, including islet transplantation for systemic lupus
erythematosus, and multiple sclerosis. The Network is also implementing
a study to assess the immune status of kidney transplant recipients who
have voluntarily discontinued immunosuppressive therapy yet maintained
a functioning transplant over long periods of time. Network-supported
scientists are also designing studies of several approaches to measure
the induction, maintenance, and loss of tolerance in humans in
conjunction with these clinical trials. Examples include the use of new
biotechnologies, such as the complementary ``gene chip'' microarray
technology, which will profile changes in gene expression associated
with tolerance induction therapies, and the ELISPOTR assay that will
enable scientists to analyze the expression of immunomodulatory
proteins during treatment with tolerogenic therapies. In order to
stimulate new insights that will lead to wider application of
tolerogenic approaches, all Network-supported clinical trials will
include studies of the underlying mechanisms of immune regulation as an
integral part of the protocols.
The NIDDK, with the NIAID and the National Institute of Child
Health and Human Development (NICHD), is cosponsoring a clinical trial
to test the ability of subcutaneous or oral insulin by inducing immune
tolerance to prevent or delay the development of type 1 diabetes in
relatives of patients with the disease who are at risk for development
of the disease in the next five years. The JDFI and the American
Diabetes Association are also sponsoring this multi-center, nationwide
trial.
The program, Human Islet Transplantation into Humans, will support
clinical studies using new methods to induce immune tolerance, to
prevent reoccurrence of the autoimmune destruction of beta cells in the
islet, and to prevent transplant rejection. The NIDDK, the NIAID, and
the JDFI support this program.
Immune Modulation.--Traditional immunosuppressive and cytotoxic
therapies used to treat autoimmune diseases have many serious side
effects, including a decreased ability to fight infection, tissue and
bone fragility, and malignancy. In contrast, immunomodulatory
approaches seek to modify immune injurious responses without the need
for global immunosuppression. Examples include recently approved drugs
that target the tumor necrosis factor, an important mediator of
inflammation in rheumatoid arthritis and inflammatory bowel disease.
This targeted approach appears to be more potent and less toxic than
the use of cytotoxic agents or cortocosteroids in treating these
disorders.
In fiscal year 1999, the NIAID, with co-sponsorship of the NIDDK,
the National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), and the Office of Research on Women's Health (ORWH)
of the National Institutes of Health, established the Autoimmunity
Centers of Excellence to design and conduct pilot clinical trials of
the safety and potential efficacy of new strategies for immune
modulation in multiple autoimmune diseases. Three clinical trials of
promising approaches are under development: prevention of kidney damage
in systemic lupus erythematosus through interruption of a specific
immune pathway, the complement pathway; induction of remissions in
systemic lupus erythematosus through removal of a specific immune cell,
the B cell; and prevention of the development of autoantibodies in
children at risk for type 1 diabetes through the use of insulin. These
Centers will also conduct pilot clinical trials of tolerance induction
strategies and provide important safety and efficacy data for further
evaluation by the Immune Tolerance Network.
Another new research program will focus, in part, on the
development of novel treatments for the many rare immune-mediated
diseases, some of which affect less than 200,000 people. NIH support in
this area is particularly important due to limited industrial interest
in diseases with a small market potential. A fiscal year 2000 NIAID
research initiative, Clinical Trials and Clinical Markers of Immune
System Diseases, will support the testing of new therapeutic approaches
for certain rare immune-mediated disorders, including primary
immunodeficiency diseases and autoimmune diseases. Under this
initiative, the development of new biological markers and surrogate
endpoints to measure disease risk, activity, stage, and therapeutic
response will be encouraged. The availability of specific and easily
measured biological markers will facilitate the design and evaluation
of new therapeutic strategies.
In fiscal year 1998, the NIAID initiated a program called the
Hyperaccelerated Award/Mechanisms in Immunomodulation Trials to support
investigator-initiated research applications for mechanistic studies to
be conducted in conjunction with clinical trials for immune-mediated
diseases. The applications focus on utilization of patient samples to
define: mechanisms of disease pathogenesis; immunological mechanisms
underlying the clinical intervention; and surrogate/biomarkers markers
of disease activity and therapeutic effect. The ``parent'' or ``core''
clinical trial must have independent financial support, either from
industry, private foundations, or a federal agency. This program,
cosponsored by the National Institute on Aging (NIA), NIAMS, NIDDK, the
National Heart, Lung and Blood Institute (NHLBI), the National
Institute of Neurological Disorders and Stroke (NINDS), and the ORWH,
has been highly successful. In the 18 months since its inception, the
NIH has received 29 applications and funded eight projects in
autoimmune diseases, allergy and asthma, and transplantation in
collaboration with six industry partners. Through a number of steps to
expedite peer review and award, applications are accepted monthly and
awards are made within 13 weeks of receipt.
In fiscal year 2000, the NIDDK, the NIAID, and the NICHD will begin
a new program, New Strategies for the Treatment of Type 1 Diabetes,
supporting clinical studies to test new approaches to treat type 1
diabetes, including studies of immunomodulation.
Other Therapeutic Approaches--Another approach to the treatment of
immune-mediated diseases involves ``replacing'' the immune system
through transplantation of hematopoietic stem cells. In many cases, the
patient's own stem cells are used to ensure that the transplanted cells
do not react against the body's own tissues. Stem cell transplantation
is currently being used for the treatment of several autoimmune
diseases, and anecdotal reports suggest that this approach holds
promise for inducing remission or decreasing disease severity. However,
well-controlled clinical trials of efficacy have not yet been
conducted. Therefore, in fiscal year 1999, the NIAID implemented a
research initiative, Stem Cell Transplantation for Autoimmune Diseases,
to design and conduct rigorous clinical trials of the safety and
efficacy of this new therapeutic strategy.
In fiscal year 1999, the research initiative, Pilot Clinical Trials
on Innovative Therapies for Rheumatic and Skin Diseases, was
implemented under the leadership of the NIAMS to develop innovative
therapies for the treatment of rheumatic and skin diseases. Awards were
made for research on Wegener's granulomatosis, rheumatoid arthritis,
scleroderma, systemic lupus erythematosus, and ankylosing spondylitis.
In fiscal year 1999, the NHLBI began an investigator-initiated
clinical trial of Cyclophosphamide in the treatment of the pulmonary
fibrosis associated with systemic sclerosis. In systemic sclerosis,
interstitial pulmonary fibrosis is frequent (80 percent) and is now the
leading cause of death. The mortality rate of patients with impaired
pulmonary function is 40-45 percent within 10 years of onset.
Uncontrolled studies suggest that cyclophosphamide may stabilize or
improve lung function in systemic sclerosis patients. The study is a
five-year, 13-center, parallel-group, double-blind, randomized,
controlled, phase III clinical trial of oral cyclophosphamide versus
placebo to assess the efficacy of cyclophosphamide in stabilizing or
improving the course of pulmonary disease in scleroderma. NIAMS also
contributes to the support of this study.
In fiscal year 2000, the NIDDK with the NIAID and the JDFI will
sponsor new Diabetes Centers of Excellence to support basic research
into the pathogenesis of type 1 diabetes and to develop new therapeutic
approaches to this autoimmune disease.
Question. How does NIH intend to increase coordination of research
on the family of autoimmune diseases?
Answer. In fiscal year 1998, both the Senate and the House
Appropriations Committee Reports addressed the importance of
coordination of NIH-supported research activities relating to
autoimmune diseases. The NIH recognized the need for coordination and
collaboration in this area and in fiscal year 1998 established the
Autoimmune Diseases Coordinating Committee under the direction of the
NIAID. Twenty-two NIH Institutes, Centers, and Offices, the U.S. Food
and Drug Administration, the Veterans Administration, the Centers for
Disease Control and Prevention, and private organizations that sponsor
research in this area are represented on the Committee. Some of the
private organizations include the Juvenile Diabetes Foundation
International, the Arthritis Foundation, the National Multiple
Sclerosis Society, the Systemic Lupus Erythematosus Foundation, the
Sjogren's Foundation, and the American Autoimmune Related Diseases
Association.
Since its initial meeting in June 1998, the Committee has collected
and analyzed information on current research activities and funding
levels and established multi-Institute collaborative working groups in
areas of common interest and relevance to multiple autoimmune diseases.
In addition, the Committee's efforts have facilitated a variety of
other activities to further enhance coordination of research and
increase partnerships between public and private organizations.
Examples include:
--Extensive collaboration among many NIH Institutes, Centers, and
Offices in planning and cosponsoring several new research
initiatives in fiscal year 1999;
--Establishment of public-private research partnerships between the
NIH and the Juvenile Diabetes Foundation International, the
Arthritis Foundation, and the Crohn's and Colitis Foundation of
America;
--Cosponsorship of workshops and scientific symposia by the NIH, the
Juvenile Diabetes Foundation International, the Arthritis
Foundation, and the Crohn's and Colitis Foundation of America;
--Participation of NIH staff in scientific planning activities of
non-Federal organizations, such as the National Multiple
Sclerosis Society, the Alliance for Lupus Research, and the
Juvenile Diabetes Foundation International.
The Autoimmune Diseases Coordinating Committee was instrumental in
the development, coordination, and implementation of several new
initiatives in fiscal year 1999. The guiding principles of this
planning process included an emphasis on: cross-disciplinary research
addressing multiple autoimmune diseases; support for a mechanism-based
approach, encompassing fundamental investigations of disease
pathogenesis and clinical trials involving new diagnostic and
therapeutic approaches; and selected research programs focusing on
specific diseases, new technologies, and/or extraordinary scientific
opportunities.
Several new trans-NIH initiatives emerged from this process, and
nine previously planned activities in later stages of development
received increased support. Support was provided for the following
initiatives, the majority of which involved joint sponsorship by
multiple NIH components:
--New Imaging Technologies in Autoimmune Diseases
--Environment/Infection/Gene Interaction in Autoimmune Diseases
--Autoimmunity Centers of Excellence
--Multiple Autoimmune Disease Genetics Consortium
--Target Organ Damage in Autoimmune Disease
--Stem Cell Transplantation for Treatment of Autoimmune Diseases
--Immune Tolerance Network
--Non-human Primate Transplantation Tolerance Cooperative Study Group
--Human Immunology Centers of Excellence
--Clinical Trials and Clinical Markers for Immunologic Diseases
--Rat Autoimmune Disease Genetic Resource
--Rat Autoimmune Model Repository
--Pilot Trials on Innovative Therapies for Rheumatic and Skin
Diseases
--Immunological Phenotyping of Mouse Mutants
--Human Rheumatic Diseases Registries
--Hyperaccelerated Award/Mechanisms in Immune Disease Trials
--Rheumatic Diseases Registries
In November 1999, the Autoimmune Diseases Coordinating Committee
established Collaborative Working Groups to encourage NIH, other
federal agencies, and private organizations to prospectively develop
jointly sponsored initiatives in areas of overlapping interest. Several
initiatives are likely to be published in the coming year from this
collaborative process.
The major challenges facing autoimmune diseases research today are
the: development of a mechanism-based, conceptual understanding of
autoimmune disease; translation of this knowledge into new, broadly
applicable strategies for treatment and prevention of multiple
diseases; and development of sensitive tools for early and definitive
diagnosis, disease staging, and identification of at-risk individuals.
Through the collaborative programs outlined above, NIH-supported
scientists are vigorously pursuing these goals.
______
Questions Submitted by Senator Herb Kohl
epilepsy
Question. Dr. Fischbach, I am very pleased that today NINDS is
sponsoring a conference on curing epilepsy. I am hopeful that the
discussions at the conference will lead to a clearer strategy for
research into this debilitating disease. With that goal in mind, I have
several questions:
--Report language last year discussed curing epilepsy, not just
finding new treatments for it. What is NINDS doing differently
to change its focus from finding new treatments to finding a
cure to stop epilepsy dead in its tracks?
--What is NINDS's strategy for focusing on the population with
intractable epilepsy?
Answer. Our approach to curing epilepsy is reflected in the title
of a major, White House-initiated conference we sponsored last month--
``Curing Epilepsy: Focus on the Future.'' In light of recent science
advances, and with the enthusiastic support of the research and patient
communities, we are defining ``cure'' as the prevention of epilepsy
before it occurs in people at risk, and the total elimination of
seizures without treatment side effects in those who develop the
disease. Our approach is threefold. We want to pursue innovative
approaches to medical treatment, including the identification of new
targets for drugs and new methods such as high throughput screening to
identify useful medicines. We want to improve existing surgical
treatments and develop new ones aimed at modifying the circuitry of the
brain and take advantage of new methods such as various types of
stimulation to prevent or interrupt the destructive cascade of seizure
activity. And we want to harness the power of genomic information to
understand how the mutant genes responsible for many forms of epilepsy
lead to disease so that we can identify ways to prevent or reverse that
process.
``Intractable epilepsy'' is a term that we hope will become
obsolete as our research strategies bear additional fruit. The approach
I have just outlined for epilepsy in general is really the same we hope
to apply to those for whom existing treatments have failed--better
drugs, more effective surgery, and application of what we already know
and expect to learn about the role of genes in epilepsy.
alzheimer's disease
Question. It is my understanding that some research has shown that
Alzheimer's Disease begins to destroy the brain cells of its victims 10
to 20 years before outward symptoms appear. Do we currently have the
tools to diagnose Alzheimer's Disease in its earliest stages and, if
not, what research is being done to develop that capability?
Answer. Alzheimer's disease (AD) is a degenerative disorder of the
central nervous system where neuropathological changes may begin
several decades before the disease is recognized clinically. Therefore,
the most cost-effective therapies will prevent the onset of AD before
it ever manifests itself clinically. These preventative therapies can
only be developed if we can understand and predict the initial stages
and events in the brain that lead to the development of AD.
Targeting early pathological processes necessitates development of
biochemical, neuropsychological, neuroimaging and genetic markers that
are sufficiently sensitive and accurate to identify at-risk individuals
along the spectrum from normal aging through mild cognitive impairment
(MCI) (a condition characterized by memory deficit without dementia) to
AD. Most recently, diagnostic research has focused on people with MCI.
These people are at increased risk of developing AD since 15-20 percent
annually convert to AD versus 1-2 percent in the general population
over the age of 65. A number of ongoing imaging studies are evaluating
persons who exhibit early pre-clinical or clinical signs of AD and
comparing their neuroimaging and biochemical measures to those of older
individuals who are not cognitively impaired in an attempt to identify
the earliest biochemical and imaging markers that distinguish AD from
normal age-related changes.
Current neuroimaging studies are assessing whether it is possible
to measure aspects of brain function and/or structure to identify
individuals who are at-risk for AD before they develop the symptoms of
the disease. Structural and functional imaging have been shown to be
useful in identifying diagnostic markers of AD; however, in the past,
most imaging studies have been cross-sectional and designed to
demonstrate differences between older controls and patients who were
already demented. Recently published research has conducted magnetic
resonance imaging (MRI) studies in longitudinally followed individuals
diagnosed with MCI who were at increased risk of AD. The studies
measured two areas of the temporal lobe of the brain, the hippocampus
and the entorhinal cortex, because these brain structures play a
central role in memory function and are the sites of the earliest
pathology in AD. The studies found that in older individuals with MCI,
hippocampal and entorhinal cortex atrophy were predictive of an
increased risk of subsequent conversion to AD; that is, the smaller the
brain volumes, the greater the risk. The implication of these studies
is that it may be possible to identify people who are beginning to
develop the brain structural changes associated with the disease prior
to the clinical diagnosis of AD.
Recognition and characterization of brain changes prior to the
clinical symptoms or diagnosis of AD has important implications for
improving the timing and effectiveness of interventions. If diagnostic
procedures can be developed to detect early changes in the brain, it
may be possible to develop treatments that will stop the
neuropathological and biochemical lesions of AD before clinical
deterioration begins.
Improved diagnosis of AD could also improve the design of drug
trials. Focusing drug trials on persons at highest risk for disease is
more efficient and less costly, and, among highest risk persons with
minimal or no clinical symptoms, has the added benefit of testing the
effectiveness of preventing progression of symptoms to a clinical
diagnosis of AD. Finally, earlier and more accurate diagnosis provides
patients and families important information allowing them to better
plan for future care needs and management of their personal affairs.
duchenne muscular dystrophy
Question. As you know, 1 in 3,500 boys worldwide will be stricken
with Duchenne Muscular Dystrophy, the most common fatal childhood
genetic disease. There is no treatment. Each day, two boys in the
United States die from this disease. After hearing the stories of these
boys, I am very concerned about the lack of research being done at NIH
on Duchenne and Becker Muscular Dystrophy--as well as on neuromuscular
disorders generally. The dystrophin gene was discovered through NINDS-
sponsored research in 1987; yet no new treatments have emerged. In
1999, less than 1 percent of NIH funds were spent on over 40 different
forms of neuromuscular disorders.
It is my understanding that there are currently only 17 active
research grants for muscular dystrophy research. Do you believe that is
sufficient? What is NIAMS doing to encourage and fund more research
grants in this area?
Answer. The NIAMS, together with the National Institute of
Neurological Disorders and Stroke (NINDS), considers research on the
muscular dystrophies to be a priority area. We will continue to work
with the extramural muscular dystrophy research community, as well as
interested patient organizations, to stimulate and support promising
studies in this area. In fiscal year 1999, the NIAMS invested nearly
$5.4 million in muscular dystrophy projects, an increase of over 40
percent from the previous fiscal year.
A number of exciting studies with implications for our
understanding of the muscular dystrophies have been supported by the
NIAMS in recent years. One such investigation used gene therapy to
restore muscle function in a hamster model of limb-girdle muscular
dystrophy (LGMD). In another NIAMS-funded study, researchers
successfully used the common antibiotic gentamicin to restore the
function of the gene that encodes for the protein dystrophin in mouse
models of Duchenne muscular dystrophy (DMD). In a third project, NIAMS-
supported researchers used gene therapy in mice to give the body a
boost in fighting the effects of aging on muscle, and to help repair
the damage caused by injury and muscle-wasting disorders such as
muscular dystrophy. These projects underscore the potential of treating
human forms of LGMD, DMD and other muscular dystrophies with gene
therapy approaches.
Another area of excitement relates to a new protocol developed with
support from the NIAMS that makes it possible to obtain an almost
unlimited number of a special class of adult stem cells from a small
sample of bone marrow. These adult stem cells have the ability to
develop into cells of muscle, nerve, bone, cartilage and fat. Because
of their vast potential for differentiation, they may be excellent
therapy vectors for a number of skeletal diseases, including muscular
dystrophy.
Next month, the NIAMS--in partnership with the NINDS and the NIH
Office of Rare Diseases--will support two research meetings on muscular
dystrophy. The first is an international scientific conference centered
on clinical and molecular studies of facioscapulohumeral dystrophy
(FSHD). The meeting will bring together researchers who are already
involved in FSHD projects, as well as scientists who are working in
related fields and may be able to contribute to progress on FSHD. The
second meeting will focus on therapeutic approaches for DMD. This
workshop is aimed at addressing key questions in improving treatments
for DMD, identifying areas of needed scientific knowledge, and critical
next steps to promote effective therapy. The NIH expects to build on
the insights from these two meetings to develop new program initiatives
related to the muscular dystrophies. Such initiatives would complement
on-going efforts to stimulate research in this area, including the
currently active program announcement on the pathogenesis and therapies
of the muscular dystrophies.
Question. What, if any, coordinated strategy exists between NIAMS
and NINDS to focus research on Duchenne and integrate scientific
discoveries from related research? Would a consensus conference on
Duchenne/Becker Dystrophies be beneficial in creating that focus?
Answer. NIAMS and NINDS share the lead for Duchenne/Becker muscular
dystrophy research. NIAMS brings to this role a perspective as the lead
institute for basic studies of muscle biology and most muscle diseases.
NINDS leads in the study of the many neurological disorders that affect
neuromuscular control. Since the discovery of the muscular dystrophies,
neurologists have played a major role in diagnosis and care of children
and in research on these disorders. Interactions among medical
professionals from several disciplines are increasingly important in
studying and treating the muscular dystrophies, and the involvement of
several components of NIH in muscular dystrophy research reflects this.
Some have expressed concern that no single component of NIH is
responsible for all muscular dystrophy research. The division of
responsibilities for muscular dystrophy research among components of
NIH reflects the biological complexities of the disease, and there are
substantial benefits from bringing a coordinated approach from multiple
perspectives focused on muscular dystrophy. This issue in general is an
important one for NIH. Biology does not abide by administrative
divisions. Most disorders, including the muscular dystrophies, affect
many aspects of physiology, benefit from a wide range of fundamental
biological research, and require that we explore diverse strategies for
treatment. It is therefore essential to bring to bear expertise and
resources from all parts of NIH, as appropriate. The need for
coordination is very real, and we must be vigilant. For muscular
dystrophy, NIAMS and NINDS together take the lead and have initiated
joint solicitations, scientific workshops and other activities,
involving other components of NIH.
As noted earlier, the NIAMS and NINDS are presently partnering with
the NIH Office of Rare Diseases to sponsor a workshop on therapeutic
approaches for DMD. A number of scientific questions will be explored
at this meeting with the goal of moving currently studied therapies
toward human trials. Institute staff have worked closely with the DMD
research community, as well as patient advocates, to develop the agenda
for this workshop. At present, an NIH consensus conference on DMD may
be premature--as the primary goal of such conferences is to develop a
report evaluating state-of-the-art scientific information on a given
biomedical technology with the purpose of resolving a particular
controversial issue in clinical practice. However, it is our
expectation that the meeting we are sponsoring this spring on DMD will
provide an important focus for new approaches to this disorder, and
will serve as the basis for future programmatic efforts.
Question. Concerns have been raised that there is no separate study
section for muscle biology within any of the institutes of NIH. Why is
this the case? Do you believe the NIH is properly organized to evaluate
and coordinate muscle biology-related research--specifically related to
Duchenne/Becker Muscular Dystrophy?
Answer. The NIH Center for Scientific Review (CSR), which conducts
the peer review process, is currently involved in a comprehensive
assessment of its study section structure, led by Dr. Bruce Alberts,
the President of the National Academy of Sciences. The purpose of this
assessment is to ensure that CSR provides a rigorous, unbiased review
system that facilitates the advance of all areas of biomedical
research, including muscle biology. Indeed, muscle disease review
issues are being considered as part of the assessment. CSR will also be
meeting with scientists at the Duchenne muscular dystrophy workshop in
May to discuss this and other review concerns. The outcome of these
discussions will help guide future decisions about the review of
muscle-related research grant applications.
There is no simple answer to the question of whether a dedicated
study section would enhance the success of muscular dystrophy research
applications or otherwise improve coordination of muscle-related
research. It is important to consider that the NIH receives a broad
range of research applications on muscle functioning and disease, and
diverse areas of scientific expertise are required to review those
applications. Whether it is desirable--or, indeed, even feasible--to
cluster all muscle research proposals into a single study section is
one of the questions being explored by the CSR assessment described
above.
diabetes research
Question. Over 175,000 adults in Wisconsin were diagnosed with
diabetes in 1996. In addition to the physical and life-threatening
complications diabetes sufferers face, the costs of diabetes in
Wisconsin total nearly $2.3 billion annually.
I realize that funds for trans-NIH diabetes research are estimated
to increase by 15.7 percent in fiscal year 2000, with a 14.7 percent
increase for NIH overall. In recent years, NIH has recommended to
Congress allocations among institutes that generally spread the funding
increase evenly among Institutes.
Do you think that across-the-board allocations adequately fund all
new scientific opportunities equally? How does this across-the-board
approach square with the assertion by NIH that allocations should be
made on the basis of scientific opportunity, the greatest need, and the
greatest potential for breakthroughs?
Answer. NIH recommendations to Congress regarding allocations to
the Institutes and Centers (ICs) vary each year to reflect many factors
and consultations. The NIH solicits advice from a large number of
individuals and groups, including the members of the scientific
community, patient advocacy groups, Congress, the Administration, and
NIH staff. Each IC convenes meetings of its national advisory council
or board to review a broad range of policies and sponsors many
workshops and conferences to gather opinions on specific areas of
science. The efforts of the ICs to seek external advice are further
augmented by those of the NIH Director through meetings of the Advisory
Committee to the Director and the Council of Public Representatives.
Also, last year, for the first time, the NIH held a Budget Retreat
to develop its research priorities and to establish areas of research
emphasis in preparation of the President's 2001 budget. Retreat
participants included ten external advisors in addition to the NIH and
IC leadership. As reflected in the fiscal year 2001 budget request,
proposed increases by IC range from 10.8 percent for the Fogarty
International Center to 3.3 percent for the National Institute on
Nursing Research.
The final fiscal year 2000 appropriation, incorporating NIH
recommendations, also provided a range of funding levels across the
NIH. Increases ranged from 36.6 percent for the newly-established
National Center for Alternative Medicine, to 14.4 percent for the
National Institute of Diabetes and Digestive and Kidney Diseases, with
other ICs receiving an increase in the range of 12-13 percent. By any
measure, the amount the NIDDK received in fiscal year 2000 was
substantial and unprecedented and will allow a major commitment of
resources to new diabetes initiatives. We will increase our diabetes
research efforts by over 17 percent--more than two percentage points
over the fiscal year 2000 increase provided to the NIDDK as a whole.
This increase will permit new and significantly expanded research on
type 1 and type 2 diabetes and diabetes complications. Some examples
include: expanded support for studies of islet transplantation in
humans, including support of six new research projects and the
establishment of an islet transplant registry; increased support of the
type 2 diabetes genetic linkage consortium; identifying and
characterizing the genes involved in pancreatic endocrine development
and function; funding of two new Diabetes Endocrinology Research
Centers; novel approaches to imaging functional islet beta cells;
understanding and combating the increase of type 2 diabetes in
children, especially from minority groups; approaches to diabetic foot
complications--a major cause of amputations particularly affecting
minority populations; studies of the cause and treatment of diabetic
neurologic complications; and, together with the NHLBI, support of two
major clinical trials relating to cardiovascular complications of
diabetes.
Question. Can you tell us how you plan to allocate the increases
you have been receiving as a result of Congress' commitment to doubling
NIH spending overall? For example, what will be the breakdown of
expenditures applied to existing programs and research projects,
compared to money provided to exciting new research initiatives
identified by the Diabetes Research Working Group (DRWG)?
Answer. Over 70 percent of our approximate $150 million increase
over fiscal year 1999 will be used to meet commitments for non-
competing continuations in fiscal year 2000. Much of the remaining
fiscal year 2000 increase will be directed toward congressional
emphases in diabetes and prostate disease. We are making a major
commitment of resources to new diabetes initiatives, by increasing our
diabetes research efforts by over 17 percent--more than two percentage
points over the 15 percent increase provided to the NIDDK as a whole.
The increase provided to NIDDK in fiscal year 2000 will permit new
and significantly expanded research on type 1 and type 2 diabetes and
on diabetes complications. Some examples include: expanded support for
studies of islet transplantation in humans, including support of six
new research projects and the establishment of an islet transplant
registry; increased support of the type 2 diabetes genetic linkage
consortium; identifying and characterizing the genes involved in
pancreatic endocrine development and function; funding of two new
Diabetes Endocrinology Research Centers; novel approaches to imaging
functional islet beta cells; understanding and combating the increase
of type 2 diabetes in children, especially from minority groups;
approaches to diabetic foot complications--a major cause of amputations
particularly affecting minority populations; studies of the cause and
treatment of diabetic neurologic complications; and, together with the
NHLBI, support of two major clinical trials relating to cardiovascular
complications of diabetes.
Question. What amount of funds would it take for the NIDDK to fully
implement its share of the recommendations of the DRWG? Can you find
the money to meet the DRWG recommendations in the context of a doubling
of the overall NIH budget if NIDDK is generally increased by the same
percent as the overall NIH increase each year, give or take a percent?
Answer. The DRWG Strategic Plan made both scientific and funding
recommendations for fiscal year 2000 through fiscal year 2004 for each
Institute and Center of the NIH, as well as for the NIH as a whole. For
the NIDDK specifically, the DRWG recommended that diabetes research
funding reach $501.1 million in fiscal year 2000; $654.8 million in
fiscal year 2001; and continue to rise to $989.7 million in fiscal year
2004. For the entire NIH, the DRWG recommended that diabetes research
funding reach $827 million in fiscal year 2000; $1.074 billion in
fiscal year 2001; and continue to rise to $1.6 billion by fiscal year
2004.
Diabetes research is receiving significant funding increases across
the NIH--rising from a funding level of $457.6 million in fiscal year
1999, to an estimated $525.1 million in fiscal year 2000 and an
estimated $561 million for fiscal year 2001. However, the NIDDK cannot
fully implement all of the recommendations of the DRWG, even in the
context of a doubling of the NIH budget, assuming that its percentage
funding increase generally matches the overall percentage increase for
the NIH proper. In fiscal year 2000, for example, even if the NIDDK had
been able to apply the entirety of its funding increase of $150 million
to diabetes research, it would still have fallen substantially short of
the target funding level of $501.1 million set for it by the DRWG.
The five-year funding trajectory recommended by the DRWG for NIDDK
and NIH diabetes research, respectively, would represent an increase in
excess of 3.5 times fiscal year 1999 funding levels. Thus, even if its
budget doubled in five years, it would not be possible for the NIDDK to
implement all of the DRWG recommendations in the time frame specified
without seriously harming research programs on other diseases of
national concern that are within the NIDDK's research
responsibilities--and the DRWG itself recommended against the diversion
of funds from other programs.
Question. Can you give us your opinion of the DRWG report? To what
extent do you agree that it provides a serious outline for the
direction in which our diabetes research portfolio ought to go?
Answer. The Diabetes Research Working Group (DRWG) Strategic Plan
serves as an important guidepost which the NIH is using to help frame
its diabetes research agenda. The Strategic Plan represents a year-long
deliberative planning process conducted by twelve eminent scientific
leaders in diabetes research and four lay representatives, including
representatives from both the Juvenile Diabetes Foundation
International and the American Diabetes Association. The DRWG also
solicited advice from many ad hoc scientific experts and public
commentary. The Working Group evaluated all aspects of diabetes health
issues, as well as the state-of-the-science, in an effort to develop a
comprehensive plan. Thus, the recommendations of the DRWG Strategic
Plan reflect the consensus of many talented scientists and concerned
patients about the most promising avenues we can pursue to achieve
greater understanding and more effective treatments for diabetes and to
realize means to prevent and cure both forms of the disease and its
complications. The NIH has already undertaken many new initiatives
related to the extraordinary opportunities and special needs identified
by the DRWG and will continue to use the DRWG Strategic Plan as a
scientific framework for additional new initiatives in the years ahead,
along with advice from our National Advisory Council and emerging
scientific leads from conferences, workshops and other sources of
external advice.
multiple myeloma
Question. As you well know, this committee and our colleagues in
the House both addressed research for multiple myeloma in our
respective reports last year. I especially want to thank the chairman
of this committee, Senator Specter for his leadership on this issue.
It is my understanding that you decided to include multiple myeloma
in next month's scheduled Progress Review Group (PRG) for leukemia and
lymphoma. Will this, in your opinion, fulfill the intent of the report
language requesting a consensus conference or scientific workshop on
multiple myeloma? Do you think the PRG will fundamentally change the
NCI's multiple myeloma research program?
Answer. The Leukemia, Lymphoma and Myeloma (LLM) PRG will be an
excellent way to address the report language requesting a consensus
conference/scientific workshop on multiple myeloma. It will undoubtedly
have an impact on the direction of NCI's myeloma research program.
There are nevertheless some issues that need explanation:
The PRG process may be a more useful approach for scientific
planning than either a consensus conference or a scientific workshop.
Like a consensus conference, a PRG identifies a set of recommendations
upon which all group members agree. However, a PRG goes well beyond a
consensus conference by identifying research needs and opportunities
that experts in the field agree are the most important. PRG
participants do this by reviewing many research needs and opportunities
and then prioritizing them. Consequently, a PRG also goes well beyond a
scientific workshop, which also can involve a large number of
participants but rarely results in a list of research priorities and
recommendations.
In order that each of the three cancers receives sufficient
attention during the PRG process, NCI has named three co-chairs, one
for each cancer type. This arrangement will provide leadership for each
cancer being reviewed by the PRG. In addition, NCI is committed to
sufficient advocate participation throughout the PRG process. Clinical
and scientific experts, however, will often have interests in more than
one of these diseases, and therefore it makes sense to combine these
cancers within one PRG .NCI is confidant that a combined PRG will have
a great impact on the direction of the Institute's myeloma research
program, since prior PRGs have resulted in substantial adjustments to
the Institute's breast cancer and prostate cancer programs. It is
likely that there will be some recommendations/actions that serve all
three groups of cancers as well as some recommendations/actions that
serve the unique needs of each disease and community.
The Leukemia, Lymphoma, Myeloma PRG is already well underway. The
PRG leadership team will meet in June 2000 to select the PRG membership
and to begin planning the PRG's agenda.
Question. Although multiple myeloma is a hematological cancer--
according to NCI SEER data, it is the second fastest growing
hematologic cancer in the United States--it's most obvious effects are
in the bone destruction caused by the plasma tumors. Are there any
plans to increase collaboration between NCI and NIAMS on the issue of
bone disease and multiple myeloma?
Answer. NCI is currently collaborating with NIAMS in a multi-center
epidemiologic study, entitled ``Osteoporotic Fractures in Men
(MR.OS).'' A major goal of this study is to assess the relationships
among risk factors of osteoporotic fractures and prostate cancer in
older men (>65 years old). A total of 5,700 men will be recruited in
six diverse geographical areas and will be followed for seven years.
MR. OS will provide a unique perspective on prostate cancer occurrence
influenced by the skeletal, hormonal, and lifestyle determinants
associated with osteoporosis. Findings could provide avenues for
additional research leading to preventive strategies for prostate
cancer.
Another NCI-NIAMS collaboration involving studies of bone disease
is the long-term support of the ``Rochester Epidemiology Project'' at
the Mayo Foundation. Data have been collected during the past 34 years
on the population of Rochester and Olmsted Counties, Minnesota, and
several studies within the Project have published results on bone
fractures associated with chronic disease and osteoporosis in the
elderly. Investigators have also reported the incidence and trends in
rates of multiple myeloma in Olmsted County during 1978 through 1990.
As scientific advances and new technologies increase research
capabilities to explore associations between bone disease and multiple
myeloma, the NCI and NIAMS look forward to collaborating in this
endeavor.
Question. Does the NCI have any plans, or would it consider,
establishing a working relationship with the CDC to develop more
comprehensive epidemiological and occupational health statistics to
support myeloma research activities?
Answer. NCI investigators currently collaborate with several
investigators at the CDC on epidemiologic and surveillance studies of
multiple myeloma and other hematopoietic malignancies. One study with
CDC's National Center for Environmental Health, includes multiple
myeloma and collects biological specimens needed to analyze
occupational and environmental exposures in the general population. In
another study, NCI investigators found a relationship between risk of
multiple myeloma and exposure to solvents among workers at a U.S. Air
Force base. NCI supports the continuation and expansion of
collaborative activities with the CDC to explore and develop new
methods and approaches to better understand the origins of multiple
myeloma and the reasons for the unusually high rates in certain
populations such as African-Americans.
NCI and the CDC have recently established a Memorandum of
Understanding (MOU) for implementing an enhanced and more coordinated
national cancer surveillance effort. NCI and CDC share a vision for a
federally integrated comprehensive national cancer surveillance system.
This system will build upon and strengthen the existing infrastructure,
improve the availability of high quality data used to measure the
nation's cancer burden, and advance the capacity for surveillance
research. The scope of this coordinated cancer surveillance system
includes coverage of the entire U.S. population using high quality data
to measure cancer risk and health behaviors, incidence, treatment,
morbidity, mortality, and other outcomes. As leaders and catalysts in
federal cancer control activities, NCI and CDC enter into this
agreement to enhance cancer surveillance at national, state and
regional levels. This includes developing ways of looking at each
cancer site nationally. Geographic Information Systems (GIS)
methodologies will enable researchers to link environmental exposures
with unusually high occurrences of cancer on a geographic basis. The
SEER registry and the CDC Cancer Surveillance System, especially
working in collaboration, can help identify new hypotheses for causal
studies in multiple myeloma.
In addition, the NCI coordinates and supports many epidemiological
studies conducted intramurally and extramurally, on multiple myeloma
and other lymphoproliferative diseases. Intramural investigators are
collaborating with investigators participating in the SEER program in a
large case-control study of non-Hodgkin's lymphoma to which a multiple
myeloma component has recently been added. Under analysis is a multi-
centered case-control study of multiple myeloma in blacks and whites in
the United States. It is designed to identify the risk factors for this
tumor. A new study linking total population registries, cancer
registries, and hospitalizations for auto-immune diseases is in the
planning phase in an effort to clarify the risk of familial occurrences
of multiple myeloma and other hematopoietic malignancies. Also,
analyses of existing case-control data are being conducted as novel
occupational, geographic, and environmental hypotheses arise.
______
Questions Submitted by Senator Barbara A. Mikulski
workplace environment of nih's oeo
Question. What is Acting NIH Director Dr. Ruth Kirschstein
personally doing to address concerns about the workplace environment of
the NIH Office of Equal Opportunity (OEO) and the OEO Director's
treatment of OEO employees?
Answer. Dr. Kirschstein has been deeply concerned and personally
involved in the issues related to the workplace environment of the NIH
Office of Equal Opportunity (OEO). She has discussed these issues with
all the persons involved and after such discussions did not appear to
improve matters, she assigned the NIH Ombudsman the task of resolving
the issue. The Ombudsman with the services of a mediator, experienced
in this area, developed a process of a series of meetings, some
separately with individual or groups of employees, at which they have
had the opportunity to raise specific concerns privately and some
separately with the Director, OEO. In addition, the two mediators have
held joint meetings between the employees and the Director, OEO, at
which views were exchanged. It has become clear that the issues of
which you are aware, raised by some OEO employees do not represent
those of all OEO employees. Nevertheless, it is clear that the issues
are real and must be and are being settled.
A good deal of progress has been made. The Director, OEO has been
responsive to the concerns raised by the employees, and has undertaken
certain necessary steps to address the most pressing matters. In
addition, the NIH has resolved the specific concerns of two OEO
employees, and has entered into agreements with them that fully satisfy
their concerns. Other actions are in progress and we are optimistic
that a satisfactory outcome will result.
minority representation
Question. Please specify what specific steps NIH is taking to
address the following items, providing specific timetables for actions
that NIH will take to:
--ensure that NIH has sufficient representation at all levels of
African Americans, Native Americans, Latinos/Hispanics, Asian
Pacific Americans and how NIH Institute and Center Directors
will be held accountable for meeting established goals (OEO)
--retain African Americans at NIH (OEO)
--improve the tenure rate of African American scientists at NIH (OIR)
Answer. While no Federal agency can legally assure that its actions
will result in complete representation of all minority groups based on
their availability in the work force, including persons with
disabilities, many proactive steps are underway by the NIH to achieve a
diverse organization. Under the auspices of the NIH Affirmative Action
Planning Program (AAP), each Institute and Center (IC) has the
flexibility to set annual hiring goals. Based on an annual analysis of
underrepresentation that is conducted of the various occupational
series, goals are then established, based upon projections of
anticipated hiring need. Individually tailored recruitment strategies,
necessary to address the specific underrepresented EEO groups within
its organization, are targeted for each vacancy. At the end of each
fiscal year, the ICs report their accomplishments.
IC recruitment strategies vary, according to the targeted audience
and the vacancies under consideration. They may include the use of:
Career Opportunity Training Agreements, the Student Temporary
Employment Program, advertising of vacancies on the Internet, exhibits
at conferences such as those of the Association of American Indian
Physicians (AAIP), the American Council on Education, the American
Indian Science and Engineering Society (AISES), the National Hispanic
Medical Association, the Student National Medical Association, the
Hispanic Association of Colleges and Universities (HACU), and the
Society for the Advancement of Chicanos and Native Americans (SACNAS).
Additional recruitment activities are held at other professional
meetings as well, including those of the Mexican-American Engineers and
Scientists (MAES), the Association of Minority Health Professions
Symposium (AMHPS) on Careers in Biomedical Professions, the League of
United Latin American Citizens, the National Council of LaRaza, and the
National Black Nurses Association. Additionally, EEO Officers attend
local career fairs at George Washington University, Morgan State
University, University of Maryland-Baltimore Campus, and Bowie State
University.
Responsibilities for Equal Employment Opportunity Programs are
included as an integral part of managerial performance elements to
establish accountability. The OEO guidance to IC Directors on specific
areas for inclusion in their annual accomplishment reports, as required
for SES managers, serves to maintain consistency across IC lines. All
SES managers have a separate element which is reviewed by their
respective IC Director. All IC Directors' annual accomplishments and
accompanying proposed ratings are reviewed by a subgroup of the NIH
Performance Review Board. The Director, OEO, is a voting member of that
group. Additionally, the NIH requires a performance appraisal covering
EEO Program accomplishments for supervisors and managers through the
use of either the stand alone critical EEO performance element or an
overall supervisory or management element that incorporates EEO
responsibilities. An EEO Program element is also part of the annual
Commissioned Corps performance review mechanism and is one of 18
critical elements that comprise an officer's annual rating.
In June 1999, the NIH established a Corporate Recruitment Task
Force designed to develop global trans-NIH recruitment strategies
including those needed to address barriers to minority representation
in the NIH work force. Its members include IC EEO and Personnel
Officers as well as Office of Equal Opportunity(OEO) staff members.
Common goals include the development of a unified corporate approach to
recruitment and related issues such as relocation matters, recruitment
techniques, and targeted occupations common to all or most ICs.
Implementation of the Task Force's objectives is scheduled to begin in
fiscal year 2001.
The recruitment of minority and women scientists is extremely
competitive both within the Federal government and private enterprise.
NIH continues to use the pay flexibility provisions of Title 42 and
Title 38 to attract candidates to the NIH campus. Additionally, the NIH
AIDS Research, Clinical Research, and General Research Loan Repayment
Programs are used as recruitment incentives for minority and women
scientists. The NIH Undergraduate Scholarship Program offers
competitive scholarships to students from disadvantaged backgrounds who
are committed to careers in biomedical research. In 1999, 10
scholarships were awarded to African American (1), non-minority (4),
Asian/Pacific Islander (1), and Hispanic (4) students.
To foster an environment that attracts and retains minority
employees, the OEO sponsors Workforce Diversity Initiative (WDI)
activities. These activities promote equal opportunity goals, engender
respect for the similarities and differences that employees bring to
the workplace and assist managers and supervisors in learning how to
capitalize on those similarities and differences while promoting
quality, fairness and efficiency. For example, the OEO sponsored an
educational project entitled the ``NIH Diversity Book Bridge Project.''
This project took a fresh approach of using literature as a tool to
discuss diversity issues. Guidance is regularly provided to the IC
Diversity Catalysts to supplement the Catalysts Implementation Manual
which was designed to identify specific duties for the newly appointed
Catalysts in the ICs. The OEO staff provided a second document,
``Guidelines for OEO Diversity Program Managers'' (DPMs), for the OEO
staff in their role as consultants to the ICs in the implementation of
the WDI. Sharing the guidelines on DPM roles with the ICs was meant to
reinforce the value of developing long term strategies and processes to
promote the WDI throughout the NIH. In November of 1999, Vice President
Gore's Special Diversity Task Force recognized the NIH diversity
process as a best practice, referencing in particular, the unique
appointing of Diversity Catalysts in each of the ICs. Some of the ICs
have incorporated the Quality of Work Life Plans into their diversity
initiatives as a method of creating a healthy work environment for
employees.
The NIH is also deeply involved in several ongoing Departmental
Minority Initiatives. For example, the employment aspects of the
Departmental Hispanic Agenda for Action and other minority initiatives
related to annual recruitment activities are addressed. During fiscal
year 1999, there was a significant increase in the number of HACU
interns as compared to the participation rate of 10 during the previous
fiscal year. Total participation during fiscal year 1999 numbered 21: 7
during the Spring Semester and 14 during the Summer. There were 7
students enrolled in the Washington Internship for Native American
Students (WINS) Program, and 10 African American interns from the
National Association for Equal Opportunity in Higher Education (NAFEO)
Program.
Data shows that NIH needs to continue its efforts to address the
retention of African Americans, particularly African American males in
the scientific occupations. Several years ago, an exit interview
program was established and a questionnaire was administered to all
employees leaving the Agency. Based on the low response rate to the
questionnaire, however, the program was discontinued. Lacking the
ability to clearly identify a pattern of the reasons employees left the
NIH, other actions have been taken to try to improve the NIH work
climate as much as possible. For example, the Center for Cooperative
Resolution has been shown as an effective alternative to the
traditional methods of conflict management. Headed by an Ombudsman, the
Center regularly evaluates new approaches to conflict resolution and
encourages employees to develop new and more effective ways to deal
with issues they face in the workplace. The Center has addressed more
than 400 cases with a resolution rate of better than 80 percent. The
Center offers a variety of alternative dispute resolution processes,
including facilitation, mediation, shuttle diplomacy, and systems
change. Within the past year, the Center has begun other initiatives
such as the implementation of a seminar series on conflict for
executives, utilization of Peer Panels, as well as preparation of
preliminary plans for partnering agreements for scientific
collaborations. More and more employees are becoming informed of the
availability of the Center from briefings, publicity, and its
reputation for efficiency, confidentiality, and neutrality. At the same
time, the Federal discrimination complaint processing mechanism is
communicated to all employees who may wish to utilize its provisions in
seeking redress of employment related concerns.
As reflected above, the objectives of the NIH AAP have served to
identify and recruit minority members, women, and persons with
disabilities into the work force. Once recruited, additional
initiatives mentioned above, such as the WDI, have been taken to create
and maintain a healthy work environment for employees.
Tenure at the NIH is granted to outstanding scientists who have
made major contributions to biomedical research and includes both
salary support and commitment of research resources subject to rigorous
review every fouryears. Tenure differs from permanent appointment in a
civil service position since it includes research support as well as
salary. Tenure policy and procedures at NIH were completely revamped in
1993 with additional modifications made in 1996. A major intent of the
new tenure policy was to provide equality of access and opportunity for
all individuals qualified for tenure-track positions. Tenure-track
positions are the principal point of entry for investigators to achieve
tenure at the NIH. The specifics of the policy and procedures may be
viewed at the following websites:
The Tenure-Track Program at http://www1.od.nih.gov/oir/sourcebook/
irp-policy/tenure-track.htm
Tenure in the NIH Intramural Research Program--Modifications to
Policy at http://www1.od.nih.gov/oir/sourcebook/irp-policy/tenure.htm
Search Process for Tenure and Tenure-Track Investigators at http://
www1.od.nih.gov/oir/sourcebook/irp-policy/search.htm
All tenure-track positions are advertised nationally using an
advertisement that must be approved by the Deputy Director for
Intramural Research (DDIR). A Search Committee must be established for
every tenure-track position that becomes available. The composition of
the Search Committee must also be approved by the DDIR and each
committee must have as voting members a scientist who is an under-
represented minority, a woman scientist and a scientist selected by the
DDIR to serve as his representative.
Despite these efforts to attract and recruit to NIH under-
represented minority scientists, from January 1999 through March 2000,
NIH hired a total of 34 tenure-track investigators, of whom 1 (2.9
percent) is African American. From January 1999 through March 2000, 34
total investigators successfully achieved tenure, of whom 2 (5.9
percent) are African Americans. This number represents 100 percent of
African American candidates considered for tenure.
To increase the pool of qualified candidates for tenure-track and
tenured positions at the NIH, the NIH intramural program continues to
increase efforts to attract under-represented minorities into research
training programs early in their biomedical research careers, to
provide training in biomedical research and to acquaint trainees with
the career opportunities available at NIH. It is expected that research
training opportunities such as the Summer Internship Program for high
school, college and graduate students (http://www.training.nih.gov/
student/internship/internship.asp), the Undergraduate Scholarship
Program (UGSP) for undergraduate students from a disadvantaged
background (http://ugsp.info.nih.gov/), the Postbaccalaureate
Intramural Research Training Award for students that have obtained
their Bachelor's degree and fully intend to pursue doctoral degrees in
the biomedical sciences (http://www.training.nih.gov/student/Pre-IRTA/
previewpostbac.asp), and the newly created NIH Academy for
postbaccalaureates interested in domestic health disparities (http://
www.training.nih.gov/student/Pre-IRTA/irtamanualpostbacAcademy.asp)
will help increase the pipeline of under-represented minorities who can
successfully compete for tenure-track and tenure positions at the NIH.
CONCLUSION OF HEARINGS
Senator Specter. Thank you all very much for being here,
that concludes our hearing. The subcommittee will stand in
recess subject to the call of the Chair.
[Whereupon, at 10:53 a.m., Thursday, March 30, 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 2001
----------
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 HEALTH AND HUMAN SERVICES
General Healthcare
Prepared Statement of Persons United Limiting SubStandards & Errors in
Healthcare of Colorado
Mr. Chairman and Members of the Committee: Thank you for allowing
me this opportunity to submit written testimony to request funding for
public education to help reduce Medical Errors. As a consumer advocate,
I feel that it is imperative to budget funding for public education,
consumer Hotlines and an Federal agency that will oversee all state
medical boards and create national standards of care that will be
communicated to the consumer. It is ludicrous to believe that the many
problems in the present system will be remedied anytime soon.
Therefore, the consumer must know exactly what their responsibility is
as an informed and savvy patient to reduce the incidence of medical
errors.
I lost my mother in February of 1995 under similar circumstances to
those that Debra Malone lost her father, Dr. Karl Shipman. A
combination of inexperienced and overworked hospital nurses, an inept
and arrogant physician, misdiagnosis and medication errors caused my
mother to suffer a myocardial infarction as an inpatient. She was in a
coma for seven weeks before she died. Had she presented at an emergency
room with the same symptoms that were ignored on the floor, emergency
protocol would have taken the necessary tests to determine what was
going on and may have saved her life. I found it nearly impossible to
get any answers, and was appalled to learn that what my mother
experienced was common. Nothing was reported by anyone but myself and
by my own perseverance. I did not sue, had I gone forward with a civil
suit, Colorado tort reform laws would have limited any award or
settlement to less than the cost of pursuing the case. I filed
complaints with the medical and nursing boards. Both agencies initially
dismissed my complaints. The nursing board dismissed the original
complaints at a lunch. Several local nurses assisted me in preparing
the original complaints. After the luncheon dismissal, I spoke with the
nursing board administrator. She indicated that if one of the nurses
who helped me write the complaints would simply write her a letter and
sign it, she would reopen the complaints process. I asked the nurses to
do this, they all refused. Having become an advocate and networking
with other states advocacy groups, I found two out of state nurses with
impeccable credentials willing to review the records. I did not know
either of them, but they were both sympathetic to the cause and
reviewed the records for free. Paying for the review would have hurt
the credibility with the regulatory agency. Both nurse's letters said
precisely what the local nurses told me to include in the original
complaints. The administrator did keep her word, an investigation was
opened that resulted in disciplinary action for two of the three nurses
I filed complaints on. It is disturbing that the outcome was based on
the two out of state letters, not my original complaints. The medical
board told me that they would reevaluate the physician complaint if I
had a physician review the records. Unfortunately, I could not find one
anywhere in the United States willing to do this for free.
Peer review should be reporting these things to the regulatory
agencies, they are not. The regulatory agencies investigate nearly 100
percent of all peer review complaints filed. Sadly, the regulatory
agencies dismiss the majority of all consumer complaints, without
checking their validity. This is not due to lazy medical boards, it is
another facet of the present ailing system of healthcare delivery.
In our society, most of us see our doctors as family. We seem to
have a parent child like relationship with them. We hear stories of
medical errors or problems, yet we feel that our own private physician
has our care under total control and nothing like that could ever
happen to us. We regard our doctor as a child regards a parent, the all
knowing, all seeing omnipotent super hero who protects us from all
adversity. Most medical errors that occur are far from the control of
our private doctors. When we are exposed to the adversities, we become
confused and angry. The present system as it now exists does not allow
our personal physicians to communicate the entire story to us. We then
lose faith, hope and trust, we search for answers and find none. It is
then, and only then, that we seek out legal counsel, searching for
answers, truth and justice. I cannot imagine how difficult it must be
for our personal physicians to know that something went wrong, yet not
be able to comfort us, nor have a place to report the incident without
fearing the consequences of doing so. What agony it must be for our
doctors. These physicians, like us, are victims of a severely impaired
system that must change.
Medicine is not an exact science, yet we expect perfection, when we
don't get perfection, we expect compensation. How puzzling it is that
less than 2 percent of all victims of medical errors seek legal
counsel, yet the fear of lawsuits barricades voluntary reporting of
errors in medical care. Those who work inside of medicine are bound by
this code of silence. The present system has the consumer under a false
sense of security. The public must be told the absolute truth, yes,
some will do without surgical procedures that they would have had not
knowing the full risks. The public must be told when they are being
treated by doctors in training, and that the risks of this lack of
experience may be harmful to them. Yes, some will refrain. The public
must be told at once when an error occurs, most victims would walk away
with this simple explanation. But, it does not work that way. The
threat of litigation prevents medical boards from doing their jobs
effectively because they fear that their hard work will become free
discovery for less then 2 percent of all incidents. It is a vicious
cycle that leads to nowhere.
Imagine how plaintiffs feel years after the incident when their own
attorney tells them to accept a modest out of court settlement, and
sign a document prohibiting them from discussing the case indefinitely.
Imagine how consumers feel when they read the release that they must
sign that states that the defendants admit no guilt. These settlements
are reported to the NPDB, but what good does it do for the peace of
mind of the plaintiff? What good does it now do for future victims of
the same incident when nothing is admitted?
Both the medical profession and the consumers are programmed to
believe a lie, we have been sold a bill of goods that simply is not
true. It is a no win situation for everyone involved. In Colorado,
there have been only 63 plaintiff verdicts in medical malpractice cases
in our courts in seventeen years. The odds of going to trial and
winning are not in the favor of the plaintiff. Why?, because, when all
is said and done, and the truth is finally forced, it is usually in
favor of the provider, because, ``Medicine is not an exact science,
there will be adverse outcomes, and when a physician uses due care,
diligence and does make a mistake, he or she is not accountable for it
in civil court''. Now, if this simple truth were told from the
beginning, think of how much grief, anguish and suffering could be
avoided, on all sides. That is what is wrong with the present system.
It does not work, and as long as we allow this sham to go on, we are
doing a grave injustice to society.
One member of our organization who lost her child because of poor
medical care found out there was a previous board action against the
doctor involved for using poor judgment in another death of a child.
This physician was grossly overworked, seeing too many patients per
day. She had taken her child to see this doctor several times a week
before he died. At one point she took him to an emergency room and the
other doctors ``did not want to get involved''. The doctor in question
also missed important signs of trouble with several other patients.
However, this physician also did a great deal of good for other
patients. Our town, and our organization were heavily spilt over the
Medical Board's decision to suspend his license. This doctor was a
victim too, a victim of a savage system that, even though local peer
review knew of adverse outcomes that were preventable, they were silent
and did not report them to the medical board, nor did anyone help this
doctor with his patient load. The controversy and rumors surrounding
this doctor was that he truly loved the children he was treating, he
and his partner were the only ones in town who wanted to provide care
for Medicaid children, other doctors sent Medicaid children to him. The
local medical community made no effort to bring in other doctors
interested in Medicaid reimbursements. Knowing that this doctor would
be up all night at local hospitals with families of sick children, the
local medical community did nothing when this doctor would barely have
time to shave before returning to his office the following morning to
see other children. How can someone deprived of sleep use good
judgment? Yet, when the medical board suspended this man's license
based on evidence that they had gathered from many consumer complaints,
the medical community remained silent, some other doctors rallied
around this doctor and encouraged him to not take responsibility for
his mistakes. They allowed this to go on for so long and finally when
the state attempted to intercede, the local medical community closed
ranks, cried sour grapes, got political and told the state to stay out
of local affairs. This made it very difficult for the board, the nurses
and consumers who were brave enough to act. The doctor and the board
came to an agreement where he will retire early, and of course, have a
clean record. How will this effect future care by this provider in
another state?
Why is it that only 2 percent of all consumers affected by medical
errors seek legal counsel? Could it be that the rest of us tirelessly
go from one attorney to another with our tales of grief but none seem
interested in our cases? Not because we were attempting to file
frivolous lawsuits but because the attorneys know the usual outcome of
a trial. They know the high percentage of verdicts are found for the
defendant, not the plaintiff. They know most settlements would barely
cover court costs and fees, expert testimony etc.. The reason for this
needless heartache for those who believe that they have already been
violated or betrayed by medicine is this code of silence, the lack of
an honest explanation when something goes terribly wrong. The time has
come for the secrets of medicine to be shared with the consumer, in
easy to understand language. All too often the elusive ``standard of
care'' for a particular malady is virtually untouchable by the consumer
until the case gets to trial in civil court. At that time ``expert
witnesses'' explain to the non medical people of the jury what happened
to the patient in plain terms. These explanations are why most doctors
are found not guilty of medical malpractice in our nations courts. Only
at this time are the errors or mistakes made public, yet most consumers
know little about researching court documents. These errors again go
unreported, instead of being addressed, usually get lost in the
shuffle. Admitting the error from the beginning would have avoided the
costly ordeal for both the plaintiff and the defendant.
If there were a National Patient Safety Board, designed much like
the National Transportation Safety board, Federal standards would then
be in place and any deviation from such standards would be addressed
and dealt with for the sake of public safety.
Medical errors are at an all time high, people from all walks of
life are affected. Things have gotten so out of control that medical
errors resulting in preventable deaths now even touch the lives of
physicians themselves. Inefficient health care delivery has become a
way of life and must no longer be tolerated. Many providers ask how
have things gotten this bad? In every other consumer related industry,
there are standard safety guidelines, this is not true in medicine. It
appears that if there are no real standards to follow, no consequences
due to lackadaisical behavior, and no rewards for creating
accountability and dealing with problems, why strive for excellence? We
must then depend on pure conscience of the brave insiders who blow the
whistle risking all, or others who learn through personal loss that
things must change. Unfortunately, it is unrealistic to believe that
this very small inside minority can police this huge and affluent
industry.
Most of us are under a false blanket of security that civil justice
and government agencies are our protectors. Nothing could be further
from the truth. Colorado recently made it illegal for a physician to
lie to the medical board in his confidential response to a complaint.
Civil justice no longer exists, instead the remnants of what once may
have once been civil justice, have been replaced by a great theatrical
and costly fiasco that sucks everything from both sides of the case at
hand. The medical industry does not own up freely to mistakes nor does
it do anything to correct them, thus leaving the American people with
the shadows of a long gone system of honor, truth and justice.
Voluntary reporting of medical errors already exists, it has for a long
time. Voluntary reporting of errors was the reason the National
Practitioners Data Bank was created. Why then did the IOM study reveal
such startling results? Why do we want to reinvent the wheel? We must
have mandatory reporting and public education to seek excellence.
Public education is the only way to help consumers be better
patients and take more responsibility for our own healthcare. As is
being pursued in other areas, there must be a national media campaign
to educate consumers on taking more responsibility and not being so
dependent on the healthcare system to take care of them. As early as in
middle school, public education programs must begin, teaching
individuals responsible receivership of healthcare. Monthly meetings
for senior citizens could be taught in public places by volunteer
health care providers. Consumers would be encouraged to learn from
information already available on the illness or disease that they have
been diagnosed with. All would be encouraged to ask questions. Hotlines
would be established for questions and answers. All information on
credentials will be available and providers would encourage consumers
to use these resources. Public Service announcements on television
would provide consumers with a toll free number and web site
information for many rich resources already available for those of us
of seek them out. All informed consent forms would be given to all
scheduled surgical candidates a minimum of one week before surgery for
review to insure the consumer knows exactly what they are signing.
There would be a consumer advocate employed by the hospital or out
patient facility to explain the consent form to anyone having
questions. Consumers must do their part to insure safety in medicine.
Providers must allow consumers to do this without offense.
Consumers must be taught how to better communicate with all
providers. They must know more than they presently do about their own
bodies, conditions, and illnesses. Consumers must know how to recognize
an error in the making and personal physicians must be permitted to
advocate for their patients when the patient is in a hospital
situation. Consumers who are elderly or mentally impaired must have
someone else available to advocate for them at all times. Excellence in
medicine will come about only after crossing into a new frontier where
physicians and consumers work together as a real team.
Thank you for allowing me to submit written testimony. I am
available to testify before the committee if need be. I can supply you
with additional documents and information upon request.
______
Prepared Statement of the American Medical Association
On behalf of its 300,000 physician and medical student members, the
American Medical Association (AMA) would like to share three of its
most pressing concerns with the Administration's fiscal year 2001
budget proposal submitted to Congress on February 7, 2000. We hope that
you will take our concerns into account and look forward to working
with you as the Committee begins the appropriations process for the
fiscal year 2001 budget.
user fees
Through its budget proposal, the Administration has once again
proposed user fees for physicians who submit claims on behalf of their
patients. As background, several years ago, Congress enacted
legislation requiring that physicians treating Medicare patients submit
these claims to the Medicare program on behalf of their patients.
Congress has repeatedly rejected the Administration's attempts to shift
Medicare program costs onto physicians through user fees. These user
fees are nothing but a tax on the physician/provider community, and we
urge you to again reject them once again.
First, the budget proposal would also tax physicians $1 for each
paper claim submission. The Administration admitted last year that this
would have impacted 21 percent of all Part B Medicare claims and 4
percent of Part A Medicare claims at a cost of $495 million over five
years. This would be an extraordinary cost for physicians to bear
simply because their offices have not been linked to an electronic
network. This tax is especially unwarranted since many physicians may
feel more comfortable submitting hard copies of claims to their
carriers given the negative experiences that some physicians have had
with their carriers and the issues surrounding confidentiality of
patient records.
Second, the budget proposal would penalize physicians for
resubmitting claims even when payment was seriously overdue or when the
contractor had rejected the claim for trivial or inappropriate reasons.
The AMA strongly objects to requiring a physician to pay to resubmit
claims to the Medicare program.
The AMA believes that physicians are already bearing an extremely
heavy regulatory burden, which increases exponentially as the Health
Care Financing Administration (HCFA) issues each new Medicare billing
requirement. Physicians should not have to bear the additional cost of
administering the Medicare program through new and unjustified user
fees.
physician education efforts
Several weeks ago, the Department of Health and Human Services
Office of the Inspector General (OIG) released the latest version of
the Chief Financial Officer (CFO) audit. The audit and its resulting
rhetoric refocused attention on billing and alleged fraudulent
activities in the Medicare program. However, by OIG's own admission,
auditors have not been able to separate inadvertent billing errors from
fraud. The CFO audit includes all types of improper payments including
inadvertent billing errors, which may involve subjective decisions open
to honest disagreement. According to the OIG's own spokesperson, ``We
don't know how much Medicare fraud there is.'' (Washington Times, 3/11/
00) The AMA has been asking since the inception of the audit for
details regarding types of billing problems uncovered related to
specialty, geographic region, and particular coding issues so that we
could educate our members on the issues uncovered. The AMA has never
been able to obtain such information.
We urge the federal government and the Congress to stop using such
a broad-brush approach and to start being more precise with its
language and its responses to these numbers. Since the advent of the
first CFO audit, Congress and the Administration have emphasized
enforcement as the way to eliminate inadvertent billing errors from the
Medicare program. The AMA urges policymakers to begin to focus on
prevention and to start implementing effective and innovative education
programs for physicians. Physicians want to comply with Medicare
billing regulations, and the AMA believes that federal resources should
be devoted to supporting extensive education efforts for physicians.
The AMA has advocated to implement systematic reforms in situations
when a carrier identifies a widespread billing problem in a physician
community. The AMA has asked HCFA to require the carriers to work with
the appropriate medical state and specialty societies to educate
physicians about a billing problem and to help them understand how to
address it in the future. We would also like to see HCFA implement
education efforts for individual physicians when the carrier identifies
that a physician has a billing problem. Physicians overwhelmingly agree
that physician-specific education in the field is not occurring.
The AMA believes that HCFA's current education efforts present
overly general directions that fail to aid individual physicians in
learning specific Medicare coding and billing requirements. The AMA
strongly urges the Appropriations Committee to specify that HCFA and
its carriers will conduct general physician education and provide
education specific to coding and billing procedures that are
encountered during pre and post payment audits. The AMA also believes
that the Committee should require HCFA to use the billing errors
identified in the most recent CFO audit to carry out billing and coding
education efforts.
The Administration has proposed in its fiscal year 2001 budget to
allocate $15.8 million in funding for Provider Education and Training
out of a total Medicare contractor budget of $1.3 billion. The funding
level for provider education and training in fiscal year 2000 was also
$15.8 million. This funding level, which represents approximately one
percent of the carriers' budget, is woefully inadequate to ensure that
physicians and health care providers learn about new changes to
Medicare laws and billing and coding requirements. The AMA urges the
Committee to significantly increase funding for physician/provider
education to ensure that fewer widespread and physician specific
billing errors occur and that the relationship between HCFA and
physicians becomes less adversarial.
toll free lines
The Administration has eliminated funding for two types of toll-
free lines during the past several years. The first type of toll-free
lines allowed physicians to call their local carrier for answers to
billing and coding questions regarding Medicare claims submissions.
This ``penny-wise pound-foolish'' approach to the Medicare contractor
budget process eliminated a ready source of information and advice that
physicians depended upon when billing the Medicare program. The AMA is
pleased that the Administrator has now indicated that she intends to
restore that capability, and we urge the Committee to ensure that this
funding is continued for fiscal year 2001.
The second type of toll-free lines were used by physicians who
submitted electronic claims to their Medicare carriers. Instead of
proposing to tax physicians for not submitting electronic claims, the
AMA believes that HCFA should provide proper incentives for those
physicians who employ this preferred method of claims submission. As
such, the AMA requests that the Appropriations Committee instruct HCFA
to reinstitute these toll-free lines to encourage electronic claim
submissions.
overwhelming regulatory burdens for physicians
The AMA believes that the Congress should recognize that Medicare
regulations are complicated, burdensome and are in need of
simplification. Princeton Professor Uwe Reinhardt described the
situation in a January 21, 2000, Wall Street Journal editorial, stating
that Medicare ``regulations have become just too complicated to
understand.'' There are more than 100,000 pages of Medicare rules and
guidances with which a physician must comply--more than the Internal
Revenue Code. Furthermore, Medicare billing frequently involves
understandable differences of opinion in clinical judgments or the
level of service provided. Much of Medicare billing is subjective and
honest people can, and do, disagree. In fact, a 1995 OIG report found
that even carriers had difficulty selecting codes.
HCFA has also acknowledged that Medicare is complex. However, the
AMA believes that the agency's commitment to reducing administrative
burdens is questionable. More than a year ago, HCFA assembled an
internal committee named the Physicians Regulatory Initiative Team
(PRIT) to review the multitude of rules, regulations and instructions
with which physicians must comply in order to treat Medicare patients.
Ultimately, PRIT was to make recommendations about how to streamline
existing regulations. More than a year and a half has passed, and PRIT
has still not finished its work.
The AMA has had some positive discussions with HCFA regarding
physician education. However, Congress has not dedicated sufficient
resources to education, and the AMA remains concerned that education
for physicians will not be a priority. For instance, in recent years,
the federal government has been holding physicians to a zero tolerance
for errors standard, while not even providing a mechanism to answer
physicians' questions. There have been numerous discussions during
MedPAC meetings regarding Medicare's complexity, and the AMA was
heartened that Congress has asked MedPAC to study the issues
surrounding Medicare regulatory reform. Regulatory reform in the
Medicare program is long overdue.
oig/carrier activity
When there is true fraud, the AMA supports federal efforts to
prosecute such acts. However, the AMA implores the Congress to
distinguish between inadvertent billing errors and fraudulent activity.
In addition, we urge Congress to consider a proactive approach to
ensure compliance by simplifying regulations and significantly
increasing funding for physician and provider education.
Placing OIG agents in carriers' offices would only further compound
the problems faced by the nations' physicians. Carriers already
understand the message coming from Washington and are working
diligently to recoup Medicare program money. Spending federal funds to
check the checkers does not add up, but rather, would serve only to
construct additional bureaucracies. These funds should be directed
towards HCFA's efforts to simplify the Medicare program and towards
carriers for direct physician education.
We stand ready to assist your Committee during the appropriations
process and look forward to working with you on these and other issues.
Thank you for the opportunity to submit this testimony.
______
Prepared Statement of Santa Rosa Memorial Hospital
Mr. Chairman, and Members of the Subcommittee, thank you for the
opportunity to submit testimony to the hearing record regarding the
proposed Northern California Telemedicine Network. This network will
consist of a hub located at Santa Rosa Memorial Hospital in Santa Rosa,
California and will serve over 11 hospitals, health centers and clinics
in Sonoma, Napa, Mendocino, and Humbolt counties.
Santa Rosa Memorial Hospital is moving aggressively to build a
permanent telemedicine infrastructure to expand health care services,
as well as education and prevention programs into these currently
underserved areas. The core of this initiative will be located at the
Santa Rosa Memorial Hospital Emergency Department that will serve as
the ``hub,'' for this regional telemedicine network, providing access
to primary, specialty and trauma care services.
The Northern California Telemedicine Network will work with other
institutions to develop twelve ``spoke'' sites throughout northern
California during the initial years of the project including:
--St. Joseph's Hospital, Eureka, California
--Redwood Memorial Hospital, Fortuna, California
--Mendocino Coast District Hospital
--Petaluma Valley Hospital
--Rohnert Park Healthcare Center
--Redwood Coast Medical Services
--Anderson Valley Health Clinic
--Mendocino Coast Clinics
--Potter valley Community Health Center
--Long Valley Health and Dental Center
--Mendocino Community Health Clinic
The growth of this network will enable a telemedicine program to
achieve maximum cost effectiveness by serving multiple spoke sites from
a single hub. In addition, it is anticipated that the spoke sites will
develop some synergies as a result of their telemedicine technology
that will allow them to communicate more effectively with each other
and, importantly, with the communities most urgently in need of those
services through the use of telemedicine technologies.
As I am sure that you are aware, rural America is experiencing a
shortage of primary care physicians and specialist care providers.
Primary care physicians are the keys to meeting the basic health care
needs of patients in these areas because they are able to provide a
wide variety of basic health services and identify medical problems
needing further attention. Twenty-nine percent of rural residents live
in Health Professional Shortage Areas (HPSA) compared to only nine
percent of urban residents. Statistics from the Office of Statewide
Health Planning and Development in California show that in northern
California alone, all of Del Norte county and portions of Sonoma,
Mendocino, Lake and Humboldt Counties are all experiencing Primary Care
Health Professional Shortages.
People living in remote areas struggle to access timely, quality
medical care. Residents of these areas often have substandard access to
specialty health care, primarily because specialist physicians are more
likely to be located in areas of concentrated population. Because of
innovations in computing and telecommunications technology, many
elements of medical practice can be accomplished when the patient and
health care provider are geographically separated. This separation
could be as small as across town, across a state, or even across the
world.
Many areas in California, specifically Northern California are
medically underserved areas. The United States Department of Health and
Human Services has classified portions of Sonoma, Mendocino, Humboldt,
Del Norte counties and all of Lake county as federally designated
medically underserved areas. Access to medical care, especially
specialty and trauma care is limited and episodic at best.
Often, these communities have been medically underserved due to the
concentration of specialty care and health education in urban and
suburban neighborhoods. The use of Telemedicine serves to provide
California's underserved patients with the medical services they need.
Instead of the patient being forced to travel long distances to reach a
specialized provider, the patient, instead, could see their local
provider and receive specialized care via telemedicine saving time,
improving safety and providing a much needed service for the patient.
Additionally, the need for emergency transport of patients would be
significantly decreased due to the ability of telemedicine to assist in
the diagnosis of a trauma patient on site. California could
significantly benefit from the development of telemedicine due to its
large geographical area with a population located in big cities,
smaller towns and isolated rural regions.
Telemedicine has the potential to improve the delivery of health
care in America by bringing a wider range of services to underserved
communities and individuals in both urban and rural areas. In addition,
telemedicine can help attract and retain health professionals in rural
areas by providing ongoing training and collaboration with other health
professionals.
Santa Rosa Memorial Hospital is grateful for the initial funding
that your subcommittee provided in fiscal year 2000. This funding will
enable us to establish the first like. We look forward to working with
you to secure additional funds which will enable us to link the
remaining 10 sites throughout California's north coast.
Mr. Chairman, we believe that Santa Rosa Memorial Hospital's
Northern California Telemedicine Network creates a national model for
providing access to primary, specialty and trauma care services for
remote and at-risk populations. Our desire is to provide a much needed
service--primary and specialty care--to these underserved communities.
Therefore, Santa Rosa Memorial Hospital is seeking $2 million in
continued federal support in fiscal year 2001 for the implementation of
the final phases of its Northern California Telemedicine Network. The
federal investment will enhance our nation's commitment to protecting
the health of our citizens. Your support for this effort will improve
the quality of health care and contribute to the saving of lives for
thousands of individuals in Northern California.
Thank you for your interest.
______
Prepared Statement of the Condell Medical Center
Mr. Chairman, thank you for the opportunity to present this
testimony for the record regarding the proposed Regional Center for
Cardiac Health Services at Condell Medical Center, in Libertyville,
Illinois.
As you may know, in the United States today, cardiac diseases are
the number one killer of men and women. Everyday, more than 2,600
Americans die of cardiovascular disease, an average of one death every
33 seconds. Among both men and women, and across all racial and ethnic
groups, cardiovascular disease is the number one killer in the United
States. More than 960,000 Americans die of cardiovascular disease each
year, accounting for more than 40 percent of all deaths nationally. In
1998, cardiovascular diseases cost the nation an estimated $274 billion
in medical expenses and lost productivity, including more than $50
billion in direct Medicare and Medicaid expenditures. It is expected
that that figure has increased to $286.5 billion in 1999.
Over the last 20 years there has been a dramatic increase in the
indicators of prevalence of heart disease and stroke, particularly
among Americans over age 65--an age group that is now about 13 percent
of the U.S. population and will constitute over 20 percent by year
2010. Currently, almost 10 million Americans aged 65 years and older
report disabilities caused by heart disease. Of the nearly 5 million
patients afflicted with heart failure, 75 percent are older than 65
years of age.
Cardiovascular diseases are the most common cause of death in
Illinois, accounting for an even higher mortality rate than on the
national level. According to the National Center for Health Statistics,
Illinois had the 10th highest 1995 death rate for heart attacks, stroke
and other cardiovascular diseases in the nation, accounting for 101.7
deaths per 100,000 population. Illinois also had the 12th highest rate
of total cardiovascular diseases in the nation, at 203.7 deaths per
100,000 population.
In Lake County, IL, these statistics have even more profound
implications. Today, the County has a higher incidences of heart
disease, cardiovascular disease and chronic obstructive pulmonary
disease than the State of Illinois as a whole. In fact, Lake County had
4.6 deaths per 100,000 population from congenital anomalies versus
Illinois' 4.2 deaths per 100,000.
With a total population of 640,000, Lake County has a potential for
5,312 cardiac catheterizations annually. Currently, there are four
institutions with catheterization labs in Lake County with a combined
total volume of only 1,700 or 32 percent of the potential volume,
leaving a distinct cardiac health service need in the region. A primary
reason for this discrepancy is that many patients are referred out of
Lake County for interventional services currently unavailable anywhere
in the County. In fact, some patients are forced to travel 90 minutes
and more to obtain appropriate cardiac care.
With the region experiencing a 35 percent population growth through
2010, the need for an expanded primary and specialty health services
infrastructure, including comprehensive cardiac care, is evident.
We here at CMC are taking steps to do identify the risk factors and
implement a comprehensive program that will provide, education,
prevention, diagnosis, specialty care, surgical care and rehabilitative
cardiac care for our patients.
Since 1927, Condell Medical Center (CMC) has been a highly
respected comprehensive community health care, prevention and education
resource for Lake County, Illinois. The Medical Center has grown from
its origins as a 12-bed country hospital to a technologically
sophisticated 190-bed acute care medical center with affiliated health
care and educational service facilities strategically located
throughout Lake County.
Condell Medical Center was the first institution in Lake County to
establish a cardiac rehabilitation program in 1978. Since then, the
Medical Center has run a basic cardiology program including diagnostic
and rehabilitative services at its main campus in Libertyville, IL. It
has also provided emergency cardiac care at its main campus and its
affiliated acute care centers located throughout the northwestern Lake
County region. Currently, acute care centers are located in Buffalo
Grove, Vernon Hills, Gurnee and Round Lake Beach. Condell affiliated
medical offices are located in these centers in addition to other
medical office buildings located in Lake Villa, Grays Lake and
Mundelein. A focus on primary care physicians has enabled CMC to manage
the medical needs of a large population of patients which has
contributed to the success of its entire cardiovascular program.
Condell offers comprehensive care to area residents from the
initial onset of the disease through recovery and return to daily
routine, including:
Diagnostic Care.--Opened in 1996, Condell's new centralized
Cardiology Department began to offer diagnostic cardiac catheterization
services to area residents. One of the first fully-digital cardiac
catheterization facilities in the nation, the laboratory aids Condell
cardiologists in making a more thorough diagnosis of a patient's heart
status. This permits faster clinical decisions, increased continuity of
care and less patient stress.
Intensive Cardiac Care Center.--CMC currently operates an Intensive
Care Unit with staff trained to provide optimal patient care to those
with life-threatening illnesses. Monitoring equipment links patients
with nursing staff. The Total Care Team, through its interdisciplinary
cooperative efforts, handles the most critical situations in an
efficient, well-organized manner to produce the most effective results
for the patients.
In the cardiac care program at CMC is primarily comprised of non-
invasive diagnostic and rehabilitative care. The Medical Center
referred patients in its primary and secondary service areas to other
outlying hospitals for specialty cardiac surgical services. In 1997,
1998 and 1999 a total of 240, 343 and 376 patients respectively were
referred directly from Condell for interventional cardiac procedures.
The practice of referring patients for care interrupted the
continuity of care, increased the health risk to the CMC patient,
inconvenienced the patients and their families and broke the chain of
care between the patient and their primary care physician.
Additionally, the cost of care for those patients who are referred
increases significantly due to transport costs, repetition of certain
diagnostic tests, physician and nursing assessment during the patient
admission to the tertiary hospital.
In 1996, CMC established its Cardiac Catheterization Lab providing
diagnostic cardiac catheterization services as the first step in the
establishment of a regional center for cardiac health services. The
catheterization lab established a quality care program with
comprehensive peer review process and outcomes measurements.
With the establishment of the catheterization lab in 1996 and the
resulting increases in demand for services in 1997, 1998 and 1999, it
became very apparent that the patients of Lake County have chosen CMC
as the hospital-of-choice for their cardiac care.
Today, cardiovascular disease represents 20 percent of all CMC's
hospital admissions. In 1998, CMC ended the year with 697
catheterizations, the largest market share in Lake County. In addition,
the Medical Center referred 191 patients to other facilities for open-
heart surgery in 1998. When the proposed cardiac care center opens, it
is expected that the number of cardiac care patients will increase
significantly placing additional stress on Condell's ICU, surgical and
ED infrastructure.
The addition of a comprehensive cardiac health program including an
open-heart surgery and angioplasty program will enable CMC to fulfill
its mission of providing a full spectrum of cardiac care.
the regional center for cardiac health services at condell medical
center
In response to the critical need for comprehensive cardiac health
services in Lake County, Illinois and the surrounding region, Condell
Medical Center has established the ``Regional Center for Cardiac Health
Services'' (RCCHS).
The Regional Center for Cardiac Health Services at Condell Medical
Center is being developed as a dynamic, multi-faceted facility designed
to bolster the Lake County region's ability to deal with the numerous
faces of the cardiac threat in an innovative and integrated fashion.
The RCCHS will provide a full suite of cardiovascular services
including emergency, surgical, diagnostic, education, prevention and
rehabilitation.
This Center, which is part of Condell Medical Center's planned
institution wide expansion project, will build upon existing cardiac
expertise at the Medical Center and create a full service regional
center that will include:
--Cardiac Catheterization Lab (diagnostic and interventional cardiac
cath)
--Echocardiography
--Stress Testing
--Cardiac Rehabilitation
--Cardiac outpatient monitoring
--EKG
--Pediatric Cardiology
--Cardiac ICU
--Surgical
--Prevention and Education
--Rehabilitation
The new Center will accommodate increased volume expected from the
expanded cardiac programs, the Emergency Department and the primary and
secondary service areas.
The proposed program will:
--Be clinically effective, using an interdisciplinary approach with
input from surgeons, cardiologists, ancillary professionals,
nurses, administration and importantly, patients.
--Facilitate continuity of care from admission through discharge and
after-care in the home and rehabilitation.
--Enable cardiologists to maximize patient care through decreased
morbidity and mortality through the use of interventional
cardiac procedures and on-site open-heart surgery services.
--Provide additional suites for use in open-heart surgeries.
--Reduce referrals out of CMC and Lake County, allowing closer ``home
care.''
--Provide comprehensive cardiac care 7 days a week, 24 hours per day.
--Locate all cardiac services adjacent to one another for increased
patient convenience and improved medical efficiency.
Key components of the proposed Regional Center for Cardiac Health
Services include:
surgical
Condell Medical Center will provide for the first time in Lake
County open heart surgery capability. It will provide suites for use
solely as open heart surgery suites which will co-exist within the
expanded surgical center.
education & prevention
Another aspect of the proposed Regional Center for Cardiac Health
Services at Condell Medical Center will be the education and prevention
programs. This will entail expansion of the existing Health Promotions
Program and Cardiac Rehabilitation Program. In addition, opportunities
for the development of specialty services will be evaluated and
implemented.
rehabilitative care
A key element of the Regional Center for Cardiac Health Services at
CMC will be an expanded Cardiac Rehabilitation Program, conducted at
Centre Club. The Centre Club is the on-campus health and fitness
facility at CMC. This program helps cardiovascular patients return to a
safe, healthy and active lifestyle. This two-phase program combines
education with individualized exercise prescriptions, which are closely
monitored by highly trained staff members.
As a key part of this initiative, CMC is also in the process of
adding a second rehabilitation program off campus at its Gurnee
facility.
The establishment of this center is also a critical component in
the Medical Center's goal to become the County's first tertiary care
center. Other components of that goal will be becoming a level I
emergency department, becoming a level I intensive care unit (ICU), and
becoming a level III OB/GYN facility.
Condell Medical Center is seeking $5.5 million in fiscal year 2001
two years for the final phase of its Regional Center for Cardiac Health
Services. This proposed federal partnership in conjunction with the CMC
financial commitment of $72.8 million will provide significant returns
on the federal investment through faster and more effective treatment
while helping to reduce the significant costs associated with cardiac
related illnesses in the area.
The proposed Regional Center for Cardiac Health Services will serve
as a national model for the provision and effective management of
comprehensive cardiac care in a single location for an at-risk
population. This partnership, supported by CMC's financial commitment
of $72.8 million, will provide significant returns on the federal
investment through faster and more effective treatment while helping to
reduce the significant costs associated with cardiac related illnesses
in the area. It will also help to reduce the very real costs associated
with cardiac related illnesses in the region.
Again, Mr. Chairman thank you for the opportunity to submit this
testimony for the record. We look forward to working with the
subcommittee as it strives to implement an effective system for
addressing the complex issue of cardiac care.
______
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). On behalf of the more than 140,000 federal
employees represented by NTEU throughout the Federal Government, thank
you very much for this opportunity to share our views concerning the
fiscal year 2001 budget.
NTEU represents employees in many HHS agencies who will be directly
affected by funding decisions made by your Subcommittee. NTEU
represents employees in the Health Resources and Services
Administration, Indian Health Service, Substance Abuse and Mental
Health Services Administration, Agency for Healthcare Research and
Quality, Administration for Children and Families, Administration on
Aging, Office of the Secretary, Office for Civil Rights, Program
Support Center and the National Center for Health Statistics. In
addition, NTEU represents employees in the Social Security
Administration's Office of Hearings and Appeals.
As the Chairman knows, spending has been severely constrained at
most federal agencies over the past several years. These funding
shortfalls have resulted in hiring restrictions and delayed and
canceled employee training which have made it difficult for employees
to do their best. With the deficit finally behind us and surpluses
predicted for the immediate future, we have an opportunity to provide
adequate resources to federal agencies. Doing so will enable federal
employees to carry out their agencies' missions to the best of their
abilities and provide first class service to agency customers.
The Administration's fiscal year 2001 budget request for program
management at the Health Resources and Services Administration (HRSA)
is $131 million. HRSA's goal is to bring health care services to some
of our most neediest populations, including those in underserved rural
communities, people living with HIV/AIDS, and those who are uninsured.
There is little question that HRSA provides essential services that are
desperately in need of expansion. This agency can truly no longer do
more with less.
The employees represented by NTEU at the Agency for Healthcare
Research and Quality (AHRQ) are committed to improving the quality of
patient care in our health care system. This agency's goal is to both
cut the number of medical errors and explore ways to better use
research to improve medical care in our country. The Administration's
budget proposal includes $3 million for program support at the AHRQ, an
increase over the prior fiscal year which reflects the important work
accomplished by this agency.
President Clinton's budget proposes $60 million in funding for
program management at the Substance Abuse and Mental Health Services
Administration (SAMHSA). This agency is at the forefront of efforts to
provide early intervention programs designed to discourage young people
from trying drugs as well as playing a critical role in insuring that
mental health and drug abuse services are widely available. The Office
of National Drug Control Policy estimates that as many as 5 million
Americans need substance abuse treatment, yet, they report, less than
half actually receive services. If SAMHSA is to adequately respond to
the substance abuse and mental health needs in this country, the
President's budget recommendation is the minimum that must be approved.
The Indian Health Service (IHS) is slated to receive $2.7 billion
for its health services programs in fiscal year 2001 under the
President's budget. This budget request reflects the Administration's
continuing commitment to improve health care for the millions of
American Indians and Alaska Natives that belong to federally recognized
Tribes. These additional funds will permit the employees of IHS to
continue to make a difference in the health status of the groups served
by the IHS.
The fiscal year 2001 budget request for federal administration at
the Administration for Children and Families (ACF) is $165 million. As
the Chairman knows, ACF is one of the government's premiere agencies
for promoting the health and welfare of America's children. Programs
under its jurisdiction include Head Start as well as projects that
promote and support child care, foster care and adoption efforts. The
budget request will permit ACF to hire additional staff in key areas
such as monitoring child welfare, expanding access to quality child
care and overseeing the critical Head Start Program. Funding
restrictions in past years have hampered ACF's ability to fulfill its
mission and on behalf of the dedicated employees of this agency, I urge
the Subcommittee to fully fund this request.
For fiscal year 2001, the budget request for program administration
at the Administration on Aging (AoA) is $17 million. Since the turn of
the last century in 1900, it is estimated that the population of
Americans age sixty-five and older has grown from 3 million individuals
to more than 34 million. Helping older Americans remain independent and
productive is one of the key goals of AoA. The employees of AoA operate
nutrition programs, disseminate information and are active in the
Alzheimer's programs. The budget recommendation for AoA is the minimum
that should be approved for this important agency.
NTEU also represents employees in the Office of the Secretary of
HHS. The President's budget request for departmental management is $330
million for fiscal year 2001. As you know, the employees in the Office
of the Secretary help support those activities associated with the
overall operation of the department. In addition, the fiscal year 2001
budget request includes funding to support research on significant
policy issues including welfare reform, at-risk children and youth and
improved access to health care being conducted in the Office of the
Secretary.
The President's budget request for the Office for Civil Rights
(OCR) for Fiscal 2001 is $24 million. The important work of OCR
includes enforcing the Nation's civil rights statutes that prohibit
discrimination in health and social service programs. Moreover, OCR
plays a central role in efforts to prohibit discrimination against
individuals with disabilities in programs under HHS's purview. In the
past several years, the funding levels OCR has received have not
reflected OCR's critical mission and we urge this Committee to
carefully consider the President's fiscal year 2001 request.
For the National Center for Health Statistics (NCHS), the
Administration has requested $110 million for program support in fiscal
year 2001. This budget request is intended to support NCHS's health
survey and data collection activities. One of NCHS's primary
responsibilities is to follow changes in health and health care, assess
the effectiveness of health care programs and identify health and
disease patterns and risk factors in our country. The budget request
reflects the critical work done by this agency.
As the name implies, the Department's Program Support Center (PSC)
provides support services to HHS as well as to other agencies. These
services include efforts in three areas, including human resources,
financial management and administrative operations. For fiscal year
2001, the Administration has recommended a funding level of $326
million for PSC, a small increase over the division's fiscal year 2000
budget.
NTEU also represents employees in the Office of Hearings and
Appeals (OHA) of the Social Security Administration. As I have brought
to this Committee's attention in past years, OHA is once again the
subject of reorganization efforts. NTEU has several concerns regarding
the latest reorganization effort called the Hearing Process Improvement
(HPI) plan.
As the Chairman knows, the process at OHA is judicial in nature and
is focused around the due process hearing. Disability claimants who
have not been found eligible for disability are entitled to a timely
and fair adjudication at the hearing office level. The OHA hearing
procedure permits the dissatisfied claimant to personally interact, to
personally argue his/her position directly to the decision maker. The
decision he/she receives is comprehensive and specific; it deals with
his/her situation in great detail.
One particularly innovative and successful program stands to be
eliminated if HPI is implemented. The Senior Attorney Program as
originally operated, involved approximately 475 of OHA's experienced
Staff Attorneys who in addition to drafting ALJ decisions, reviewed
those disability cases most likely to result in a fully favorable
decision before they were assigned to the disability que for an ALJ
hearing. If the evidence indicated that the case was likely to result
in a finding of disability, the Senior Attorney would complete
development of the case, including securing additional medical evidence
and appropriate medical and vocational expertise. If after such
development the case was not likely to be favorably decided without a
hearing, the case was forwarded to an ALJ for a hearing. However, if
the record established that the claimant was in fact disabled, the
Senior Attorney would draft and issue under his/her authority a fully
favorable decision.
The average processing time for Senior Attorney decisions was just
over 100 days. This was at a time when processing time at the OHA
hearing level was 386 days--more than an entire year. As a result of
the Senior Attorney Program, disabled claimants received their benefits
nearly 9 months earlier than otherwise would have been the case. From
its inception until the Program was sharply curtailed in 1999, the
Senior Attorney Program resulted in approximately 50,000 fully
favorable decisions per year.
In every respect the Senior Attorney Program has been a resounding
success. It materially improved the quality of service provided to the
public, especially those individuals who are disabled and entitled to
timely granting of their benefits. Despite its success, the Senior
Attorney as an independent adjudicator is being eliminated as part of
the HPI Plan.
NTEU is profoundly skeptical that the Hearings Process Improvement
Plan will materially improve disability adjudication at the hearings
level. In fact, the failure to retain the decisional authority of
Senior Attorneys would seem to doom HPI to failure. NTEU urges this
Subcommittee to carefully review the Hearing Process Improvement
initiative and urges the Chairman to carefully review the shortsighted
plan to eliminate the Senior Attorney Program. Without this program,
and the additional 50,000 to 75,000 decisions it will help generate
each year, there is little question that a serious degradation of in
the quality of service will result.
Mr. Chairman, thank you again for this opportunity to share our
views on the fiscal year 2001 needs of the agencies within the
jurisdiction of your Subcommittee.
______
Prepared Statement of the Montefiore Medical Center
Mr. Chairman and Members of the subcommittee, thank you for the
opportunity to submit this testimony for the record on the Montefiore
Medical Center in the Bronx, New York and the exciting new Children's
Hospital at Montefiore that we are developing.
the bronx
The Bronx has a population of 1.2 million residents, placing it
among the top 10 largest cities in the United States. Approximately
400,000 of those residents are children. Neighborhoods in the Bronx
rank among the poorest in the nation. Thirty percent of residents in
the Bronx are on some form of public assistance and/or Medicaid (31
percent). Over one-quarter of the residents have incomes under $10,000
annually and sixty percent have annual incomes below $30,000.
The Bronx population is largely composed of historically
underserved and uninsured minorities. Three-quarters of the Bronx
population are non-white--28 percent African American and 50 percent
Hispanic. The Bronx is among the nation's most underserved urban areas
with sociodemographic and health status indicators that underscore its
need for health services. Those health and social indicators include:
--An infant mortality rate which is among the highest in the nation;
--Rates of teenage pregnancy and low birth weights that are higher
than the proportions for the City and nation;
--The incidence of asthma is six times greater than the national
average;
--Bronx children living with AIDS in 1996 represented 28.5 percent of
all New York City pediatric AIDS cases, and 5.5 percent
nationwide.
--The lack of industry and a strong economic base leaves the borough
with extreme housing problems, drug abuse and crime, all
underlying problems of poverty and unemployment.
montefiore medical center
Established over 100 years ago as a chronic care hospital,
Montefiore Medical Center has become a critical resource in addressing
the health and social needs of the residents of the Bronx. MMC was the
first hospital to create a community-oriented care program in the late
1960s and early 1970s to meet the needs of underserved residents in the
Bronx. This comprehensive public/private health system provides more
than one-third of all inpatient acute care, over 42 percent of all
tertiary care, and $50 million in uncompensated care annually.
The Medical Center strives for excellence in patient care, medical
education, scientific research and community services. Staff and
faculty at MMC practice ``family-centered care,'' working with families
to promote health, prevent diseases, and alleviate the burden of
illness.
In 1995, Montefiore Medical Center performed an extensive review of
the health of their population, specifically children. The study
revealed that children in the Bronx are among the City's most needy,
with some of the City's highest rates of low birth weight, infant
mortality, HIV infections and other reportable diseases. It also
revealed that hospitalization rates for children (0-19 years) in the
Bronx are excessive at 65 admissions for every 1,000 persons--nearly
twice the average of more affluent areas.
The study also demonstrated that child health programs at MMC are
at great risk for the future. While MMC offers a comprehensive array of
child health, prevention and education services through a network of
inpatient, outpatient, and community programs and facilities, these
programs are fragmented and uncoordinated. The four-site program is
hard to sustain, and utilization declines (due to managed care)
threaten the viability of the system. It was determined that many
inadequacies exist due to the limitations of the physical environment.
Existing programs and services at MMC lack focus for the specific needs
of children and lack child and family-friendly elements.
Among the four hospitals, inpatient services for children are
inadequate and fragmented. Ambulatory services for children are
scattered throughout the system and are not well housed, and primary
and specialty ambulatory services are not adequately articulated to
meet the health and related needs of children. In addition, there are
no existing ancillary services specifically designed for children.
Finally, the fragmented nature of existing children's services makes it
increasingly difficult to staff the four-site program. Rather than
having a critical mass of pediatric primary and specialty care in one
location, this expertise is dispersed throughout the multi-site system,
making departmental cooperation and consultation difficult and staff
retention very challenging.
It is clear that a restructuring and consolidation of services for
children at MMC must take place to ensure the livelihood of the
hospital as well as the longevity of children's health services in the
Bronx. In response to this crisis Montefiore has embarked on a
comprehensive initiative to tackle the daunting task of consolidating
all of our children's services into a central location--the Children's
Hospital at Montefiore. The new Children's Hospital will serve as a
``hub'' of our child health initiative--eliminating fragmentation
within the existing child health network, enabling the provision of
services in a more direct, cost-effective manner and enabling MMC to
better and more efficiently address the ever growing health needs of
the children in the Bronx.
the montefiore child health initiative
The traditional model of children's hospitals is designed for and
focuses on chronic care. There has been very little preventive,
supportive or specialty care at children's hospitals. With the more
sophisticated understanding of childhood illness, the resulting need
for advanced care, and with the increased understanding of the
connection between an individual's health status and his/her lifestyle
and family life--a new model of children's hospitals has emerged.
The Montefiore Child Health Initiative, comprised of both the child
health services within the existing Ambulatory Care Network and the
Children's Hospital, is a unique example of a modern and aggressive
approach to the provision of comprehensive children's primary and
specialized health care services.
The Montefiore Child Health Initiative proposes a unique model of
care that will assure MMC's continued leadership in the provision of
health care and related services to children in the Bronx and
surrounding areas. That proposal includes:
An Integrated Child Health Network
The establishment of a child health network, which builds on the
existing services available through the Ambulatory Care Network, is a
necessity in the rapidly changing environment in the Bronx. The
Montefiore Child Health Initiative will ensure that the Integrated
Child Health Network provides each child with access to high quality
primary and specialty care; effective connections and communication
between existing primary and specialty care services/providers;
cohesion among the different parts of the network to ensure a full
spectrum of child health and related services; and access to the
secondary and tertiary services at the Children's Hospital so that
children and families will have the option of receiving care in an
organized, cost effective and accountable system of care.
The Montefiore Child Health Initiative will provide the
consolidation and coordination necessary to effectively and efficiently
provide a full range of services for the children and families of the
Bronx.
The network aspects of the Initiative will play a key role in
ensuring that a full continuum is and remains available for children
and their families through the existing array of services throughout
the Bronx, including:
--3 hospital outpatient departments, providing primary care,
specialty care and special programs for children;
--30 ambulatory care sites--receiving over 300,000 visits annually;
--21 school-based health clinics--providing services to over 11,000
children annually;
--The New York Children's Initiative--an innovative outreach care
program for homeless children providing care to over 6,300
children annually;
--An extensive base of privately practicing pediatricians throughout
the Bronx and Westchester County.
The ``front door'' to the planned Children's Hospital, the core of
the Montefiore Child Health Initiative, is through any one of the
affiliated ambulatory care sites in our network. Within the network
each child will have an identifiable primary care provider responsible
for their care. Any site in the system will have the ability to assess
the need for specialty services and to provide those services and
consultations on-site or through referral. There will be constant
communication between the primary care providers in the community and
the specialty care providers at the Children's Hospital or in the
community.
The network currently offers specialty services specifically geared
to meet the unique health and social service needs of children in the
community. It is critical to note that these programs do not simply
target health needs. They also address some of the underlying economic
and social issues that cause illness in children by providing
prevention and education services for at-risk youth and families in the
Bronx. Those existing special services include:
--Child Abuse Center;
--Pediatric Resource Center;
--Child Health and Safety Initiative;
--Ambulatory care to adolescents with HIV infection;
--A nationally recognized mobile lead screening and safe house
program;
--School-based health program providing direct medical services at 21
schools in the community;
--A drop out prevention program;
--Outreach to and prenatal/child care services to pregnant women who
are either HIV infected or at-risk for infection; and,
--Community redevelopment/commercial revitalization.
Pediatric Asthma Center
A dedicated center for the diagnosis and treatment of childhood
asthma is a major focus of the Montefiore Child Health Initiative. The
concept of the Pediatric Asthma Center stemmed from the disturbing
statistics about childhood asthma in the Bronx:
--Almost 15 percent of children in the South Bronx have asthma (6
percent nationally).
--African American children are three times more likely than white
children to be hospitalized for asthma, and four to six times
more likely to die from it. Rates for Latino children are also
higher than those for white children.
--More than five times as many children in the Bronx are hospitalized
for asthma compared with national rates.
--In the South Bronx, the rate is 7.5 times the national rate, and
more than twice the rate of New York City overall.
The Pediatric Asthma Center will establish a state-of-the-art
clinical and educational resource center as well as a community-wide
network of services for children and families linked directly with
schools and day care programs. The Center's services will provide
school-based education and pediatric care for children with asthma, and
will serve as a hub for a network of diagnostic and clinical services
located in Montefiore's Integrated Child Health Network. Schools and
day care centers will be linked to the Pediatric Asthma Center as well
as a local network primary care site for services, training and
educational programs. State-of-the-art technology, including diagnostic
equipment and computer links for clinical evaluation, and support for
school-based health care and education, will be key components of the
Pediatric Asthma Center.
A New Children's Hospital
The Children's Hospital will provide the critical connection
between the providers of children's health services in the Ambulatory
Care Network. It will serve as the hub of the entire Montefiore Child
Health Initiative.
The new hospital will not stand alone but will be connected to a
tertiary care center. The hospital will be programmed and staffed
specifically with the special needs of children and families in mind.
Those special features and services include:
--State-of-the-art pediatric emergency room;
--Medical and surgical subspecialty ambulatory clinical modules
designed specifically for children;
--A short stay ``Day Hospital'';
--Family support services;
--Diagnostic and treatment services;
--Age appropriate units specifically designed to care for the
individual needs of infants, school age children, and
adolescents;
--A state-of-the-art Pediatric Critical Care Unit, with specialized
activities such as dialysis and transplant technologies,
designed with adequate space for parents to stay with their
child;
--All single occupancy rooms will have parent sleep-in
accommodations;
--A playroom on each unit with age appropriate toys, staffed with
child life professionals to assist in the developmental needs
of children;
--School facilities specially designed to meet the needs of each age
group;
--Liaison child psychiatry services;
--Medical information stations on each unit.
conclusion
The implementation of the Montefiore Child Health Initiative will
elevate the quality and scope of primary and specialty health care
services to children and their families in the Bronx.
Montefiore Medical Center, with our 100 year tradition of community
service and community-based health care programs, is uniquely qualified
to implement and operate the Montefiore Child Health Initiative which
could serve as a national model of how complete health systems can
adapt to and address the very unique health and social needs of today's
inner-city, minority, children.
funding/budget sources
The new Children's Hospital and related facilities will cost $116
million for capital construction. The Medical Center is seeking $5
million in fiscal year 2001 for this critical children's hospital and
child health initiative. In fiscal year 1999 and fiscal year 2000
respectively, Montefiore received $2 million and $500,000 respectively
for this initiative. Montefiore Medical Center looks forward to
developing relationships with the Federal Government to make this plan
a reality and to serve as a model to other cities and hospital systems.
Thank you for your consideration.
______
Prepared Statement of St. Joseph's Hospital Health Center
Mr. Chairman, thank you for the opportunity to submit this
testimony and for the support that this Subcommittee gave to St.
Joseph's Hospital Health Center last year. St. Joseph's, located in
downtown Syracuse, New York, is a non-profit 431-bed hospital and
health care network providing services to Onondaga County and to
patients from 15 surrounding counties. St. Joseph's is best known for
its ranking as the #1 hospital in New York State for open-heart surgery
in terms of lowest overall mortality rate. We are very proud of this
ranking, which we have held for four consecutive years. What many
people do not know is that we are also the largest hemodialysis center
outside metropolitan New York. My statement is focused on these two
areas of expertise at St. Joseph's and how we plan to initiate a
chronic disease management model that will benefit our current patients
with heart and kidney disease and enhance the quality of life for at-
risk patients in the region. We see this initiative as one with not
only health enhancement benefits but also with significant positive
economic implications for the community and the region.
St. Joseph's provides over $7 million in bad debt and charity care
to our service region. This comes to about 4 percent of our operating
budget. This number has steadily risen over the years and we feel it
will continue to do so unless some dramatic steps are taken. In order
to increase access to patients who are underserved and at-risk for
disease, we have implemented a program of ``patient-centered care.'' We
believe we achieved our #1 ranking for cardiac care through this
process, which employs a secondary prevention model for disease
management. By applying a multidisciplinary team approach to heart
disease and preparing patients before surgery and rehabilitating them
after, we have reduced mortality rates as well as the number of second
hospitalizations. We have done this to improve the overall health of an
underserved and underinsured patient base, but also for practical
financial reasons. While our rehabilitation and education programs for
our cardiac patients are largely unreimbursed, we are rewarded by
having to perform less expensive charity care on patients who would
typically end up back in the hospital without disease management.
Recognizing that early assessment is important to reducing the
number of expensive treatments required later in life, St. Joseph's
instituted a Wellness Place at a local mall so that people could stop
in at their convenience. The Wellness Place provides free, general
health screenings such as blood pressure readings, cardiac and diabetes
risk assessment, counseling and patient education and seminars. Last
year, approximately 15,000 people used the Wellness Place. Nearly 1000
of these people were determined to be at risk for heart disease,
diabetes, or vascular problems. These individuals were offered follow-
up services intended to change lifestyle, such as nutritional
counseling, smoking cessation, exercise programs and other similar
regimens. They were also offered a choice of primary care physician if
none was identified. This is all done at considerable unreimbursed
expense to St. Joseph's but with the knowledge that a great deal of
money will be saved in the long run--for the patient, the Medicare
system and the hospital. The most dramatic economic implications I
mentioned are encompassed within this concept--but not all. At risk
patients are working people who may lose jobs if their disease
progresses. It is important to realize, however, that patients with
diagnosed diseases or who have congestive heart failure, may still work
and lead productive lives if an effective disease management program is
initiated at the earliest stage possible. The other economic benefits
come in the form of the support required for this program. I will
detail those later in this statement.
Assessment is the first line of defense in chronic disease
management; but, there are many other factors involved after this step
is taken. A program for management of disease must adequately educate
patients and then foster a sense of individual responsibility for the
importance of following prescribed regimens. This takes a great deal of
initial monitoring and time spent with patients by telephone, at
community health centers, and in the home. This also requires
coordinated community participation by physicians, nurses, pharmacists,
physical therapists, educators, behavioral specialists and even
employers.
Diabetes, leading to kidney disease and kidney failure, is the most
expensive disease in the country. The second most expensive, and #1
admitting diagnosis for Medicare, is congestive heart failure. The U.S.
spends more than $7 billion annually in Medicare dollars for these
diseases. The clinical relationship between chronic kidney failure and
heart disease (e.g., high blood pressure) requires similar early
intervention techniques as well as later management, treatment, and
rehabilitation. Utilizing resources already developed and in place for
our cardiac rehabilitation program, St. Joseph's is proposing to
further develop a chronic disease management program focused on
hemodialysis. Combining resources in this way will be cost effective
and has the potential to radically change the management of kidney
disease.
The specific objectives of the program will begin with early
identification. Timely referrals to a nephrologist can be improved so
that more aggressive treatment can be initiated to prolong kidney
function and allow better preparation of the patient for dialysis.
Second, we will identify, investigate, evaluate, and implement
technology that will promote in-center self care and home hemodialysis
modalities. The Aksys Corporation has developed a product that has the
potential of achieving this objective. Third, we will utilize the St.
Joseph's Cardiac Rehabilitation Model for the renal patient. This model
will emphasize education and exercise with the goal of improving the
percentage of patients that stay employed, reduce frequency and length
of hospitalizations, and improve patient acceptance of and control over
disease processes. Finally, we will apply our disease management
techniques to our overall goal of reducing the percentage of candidates
for kidney transplantation. The ultimate goal of the renal patient and
the health care industry is to have renal patients lead a ``normal''
life. Currently, kidney transplantation is the modality that is most
associated with that goal.
Our history of service and specialization in the areas of cardiac
and kidney disease has proven that there is a demonstrable need for a
chronic disease demonstration in these areas for the Central New York
region. The demonstration will involve relationships and initiatives in
Dialysis, Cardiac Care, Home Care, and Wellness. What we lack at this
point, is a facility that can be shared by both cardiac and dialysis
patients. Our current dialysis facility, the largest outside the New
York Metropolitan area, is woefully inadequate in every way. The
facility was originally built as a modular, temporary, unit over 20
years ago. We now treat our overload of patients in the hallways and
have legitimate safety concerns that come with overcrowding and
questions as to the future structural integrity of the plant itself. We
have not replaced this facility for financial reasons but, fortunately,
have been able to treat patients satisfactorily. We have three
satellite clinics in the region that are also operating at capacity.
Our goal is to implement our demonstration program in an on-campus
facility that will provide the space needed for dialysis, exercise
facilities, classrooms, meeting rooms, examination rooms, an acute
kidney unit, and nurse and allied professional training space. Training
of personnel is an important aspect of implementing an innovative
chronic disease model.
In terms of economic development for the region, we believe that
keeping our patients healthy and productive will have the most dramatic
impact on the economy albeit in the long term. For the shorter term, we
believe the training programs that we currently provide and will expand
in areas such as home care, nursing, rehabilitation specialists, and
counseling, to name a few, will bring employment opportunities to
people in and around Syracuse. As we expand our efforts, we will likely
train people outside the immediate area to be able to serve the
outlying areas where our satellite clinics are and in homes in more
remote locations. The facility we envision will also provide many
construction jobs over the next couple of years. The two-story
facility, equipment and program operation will cost approximately $13.2
million. St. Joseph's has requested Federal partnership grant funding
of $5.8 million that will also cover start-up operating costs. Our
partnership funding request has increased over the past two year's by
$300,000 due to our current need to upgrade our Acute Kidney Unit as
part of our overall initiative. We estimate, based on our current
services, that our operating budget will exceed $5.5 million per year.
As you know, St. Joseph's received $2 million in fiscal year 2000
from this Subcommittee to begin the planning and site preparation
necessary for the new Center. We are very grateful for this support and
urge you to complete this investment with an additional $2 million in
fiscal year 2001 toward our total requested federal share for the
initiative. Having made this request, which we realize is considerable,
we would like to assure the Subcommittee that St. Joseph's will
provide, through private sources, the remainder of the estimated total
for this effort or $7.4 million.
We recognize the magnitude of this request but believe
wholeheartedly that this facility, and the implementation of our
chronic disease management model will repay this initial investment
many times over in terms of Medicare savings and in terms of providing
a national model for replication across the country.
Thank you.
______
Prepared Statement of the American Public Power Association
The American Public Power Association (APPA) is the service
organization representing the interests of the more than 2,000
municipal and other state and locally owned utilities throughout the
United States. Collectively, public power utilities deliver electric
energy to one of every seven U.S. electric consumers (about 45 million
people) serving some of the nation's largest cities. The majority of
APPA's member systems are located in small and medium-sized communities
in every state except Hawaii. APPA member systems appreciate the
opportunity to submit this statement in support of fiscal year 2001
appropriations for the Low Income Home Energy Assistance Program
(LIHEAP).
APPA urges the Committee to support funding of $1.4 billion in
fiscal year 2001 for LIHEAP. APPA also supports the request for $300
million in emergency funds in fiscal year 2001 and supports a funding
level of $1.5 billion in advanced funding for fiscal year 2002. Because
the majority of LIHEAP monies are needed during a short period of time
in the winter months, advanced funding for LIHEAP is critical in
enabling states to effectively plan for and administer the program.
Moreover, a severe winter and escalating home heating oil prices in the
Midwest and Northeast have depleted fiscal year 2000 emergency funds
and highlight the important role LIHEAP plays for the elderly and
working poor during winter months.
Funding cuts since LIHEAP's reauthorization in fiscal year 1995
have forced a tightening of eligibility standards and, in some cases,
significant reductions in benefit levels. According to the National
Energy Assistance Directors' Association (NEADA), the primary
educational and policy organization for state LIHEAP directors, the
number of recipients has been cut by over one million households during
the recent past and average benefits have declined by about 10 percent.
Prior to the dramatic reduction in LIHEAP funding in fiscal year 1995,
the program was serving 20 percent of the eligible population, with
one-half of the recipients being elderly or disabled Americans living
on fixed incomes. Without the assistance provided by LIHEAP, many would
be forced to choose between paying their home energy bill or purchasing
other necessities of life, such as food.
As the debate over restructuring of the electric utility industry
and the issue of providing and funding ``public benefits'' programs
continues, some have stated their belief that electric utilities should
assume the entire burden of energy assistance for low income customers
as a cost of doing business. As these restructuring efforts take place
at both the federal and state levels, the risks become greater that
bills for residential customers, especially those with low incomes,
will increase as retail markets are opened to competition. The need for
full funding of LIHEAP remains critical in ensuring that all those in
need of energy assistance receive help. APPA believes that any public
benefits programs should not replace or supersede existing programs,
such as LIHEAP, that are funded by federal appropriations.
As evidence of their commitment to low income assistance, public
power systems across the country support a variety of programs
providing help to low and fixed income customers. A survey conducted by
the National Fuel Funds Network (NFFN) shows that publicly-owned
utilities raised 14 to 26 cents more per customer than other utilities
in their efforts to assist low income and needy customers in paying
their bills. Many public power systems provide special rates for low-
income households and some have residential conservation and demand
side management programs designed to reduce energy consumption.
In addition, the impact of welfare reform on energy assistance is
just beginning to be felt and LIHEAP is likely to play an important
role in the transition. Persons leaving the public assistance rolls are
entering lower paying jobs and continue to be confronted with large
energy bills. These families remain at risk.
LIHEAP is one of the outstanding examples of a successful state-
operated program. The requirements imposed by the Federal Government
are minimal and most important decisions are left to grantees.
APPA urges this Subcommittee's favorable consideration of fiscal
year 2001 funding for LIHEAP. Again, thank you for this opportunity to
present our views.
______
Prepared Statement of Denise Roberts, Board Member, PULSE of Colorado
Mr. Chairman and Members of the Committee: Thank you for the
opportunity to submit written testimony regarding this very important
issue, Medical Errors.
My testimony concerns a series of errors that occurred as my son
was under the care of a pediatrician in Pueblo, Colorado. This doctor
already had a long history of providing substandard care to other
children. Unfortunately, this information was not public knowledge nor
was it reported by this doctor's peers. In early 1999, the Board of
Medical Examiners suspended this doctors license in hopes of protecting
the children of Pueblo. The decision was an unusual one since it was
based solely on consumer complaints. The board felt that it had
substantial evidence to act upon regarding this physician who was
seeing far too many patients per day. In the grandest of public
relations campaign the wealthy physician gained momentum within the
community, and eventually the Board had a major conflict with local
political leaders, hospitals and the peer review committees who did not
initially go forward to protect the public. Several local doctors
publicly sided with the physician, placing blame on the parents of the
dead and injured children. The others remained silent. Parents and
nurses came to the advocacy group that I belong to and informed us of
this problem. The parents assumed that the new doctors would report the
problems, they were wrong. Many symptoms were ignored and not charted
by the doctor in question, the other physicians treated them without
reporting the incidents.
In a historic decision, this doctor was given back his license
several months after suspension as the board continued to pursue the
case. The local medical community closed ranks on the board, making it
very difficult for the suspension to remain effective until the
hearing. In exchange of that costly process, the doctor and the board
agreed to an early retirement in exchange for a clean record with the
medial board. This doctor can go and practice in any other state after
he retires here and the same problems could happen there.
My son Taylor Michael Roberts passed away on Feb. 25, 1998 at 14
months. He was a healthy baby until he was prescribed medicine on 9/22/
97. I would like to give you a brief history of the medical care my son
received during his illness.
It all started around the end of October 1997 when my son got sick.
I took him to Dr. Kuna's office numerous times. (10-27-97, 10-30-97,
11-12-97, 11-14-97, 11-18-97, 12-13-97, 12-22-97). It was the Friday
after Christmas, on Dec. 26, 1997, when I took him to Dr. Kuna's office
again. Dr. Rao, Dr. Kuna's partner saw us and sent us to get some test
taken to find out what was wrong with Taylor. I brought the test back
to Dr. Rao and he told me that Taylor had pneumonia and bronchitis, and
to take him home and bring him back Monday. When I took Taylor home he
was very sick all day. The next morning I took him to my personnel
physician, and was told to get him over to the emergency room
immediately. I am not a medical doctor, but a few things occurred at
the hospital that I found disturbing: (1) They only took a blood test
of my child after I demanded one be taken. (2) It was Dr. Derrington,
another pediatrician on call, not Dr. Kuna or Dr. Rao, that ordered
blood cultures. The results confirmed that my son was septic and this
was the reason he was not getting better. (3) Dr. Kuna wanted to
discharge my son days earlier from the hospital reasoning that he would
be better off at home and more comfortable there. He stated other
children had the same symptoms and were at home. (4) Dr. Kuna lied to
us saying that all the tests; blood, and other wise, were all normal
upon his release. (5) Dr. Kuna said on the discharge summary (1/5/98)
that ``I will monitor the CBC carefully'', yet, no further blood test
were taken until Feb. 22, 1998 when my son was diagnosed with
meningitis. (6) I was never aware of the fact that Taylor had staph
infection only that he was septic.
I find it most unsettling that a Doctor would lie to us about the
care of our child. This only leads me to believe that he must not
comprehend or understand how much a parent could love a child and the
lengths they would take to keep a child safe. Does he think that the
results of the blood test are irrelevant to the life of my child?
I brought my son back to Dr. Kuna for his follow up appointment on
1/16/98. Dr. Kuna stated, that he was fine, but, to continue the neb
treatments. Again, No tests were taken, or results mentioned. I took
Taylor back to Kuna's office on 2/3/98 because he and my daughter had a
runny nose and a cough. There again in his records he shows that Taylor
had bronchitis. This was never mentioned to me during my visit. Then I
took him back and on 2/7/98 Dr. Rao said he has a viral infection. I
called Dr. Kuna on Sunday morning (2/22/98), and told him that Taylor
was very sick and that he needed to be seen immediately. Dr. Kuna
agreed to meet me at his office between 9:00 and 9:30. I told him
Taylor had the following symptoms: (1) Fever on Friday night of 99
degrees (2) Fever on Saturday night of 103.8 and not very controllable
with the baths and switching Advil and Tylenol (3) Vomited once after
the Advil (4) Heavy breathing. (5) Bumps on the back of his neck. (6)
Was given Tylenol right before our visit.
He informed me that Taylor had a virus infection and was prone to
high fevers. I was not satisfied with this diagnosis, and asked him to
do a throat culture. He said he had seen one lesion in Taylors throat.
Then Kuna checked to see what his oxygen level would register. The
machine showed a level under 90; Kuna then squeezed the monitor around
his finger. I asked him if this would make the monitor reading high. He
said it would have a misleading reading of three to four degrees which
would make Taylors oxygen level okay. I still insisted that he should
give me some medicine for Taylor. My son did not look very good at all.
Later on in the afternoon I called Dr. Kuna and explained to him that
my child was still very sick. Once again, I was told not to worry it
was just a virus. I noticed on the records of my visit (2/22/98) that
Kuna noted Taylor had a questionable dull left eardrum. This was not
reported to me during this visit. Kuna then stated in the discharge
summary `` I requested medicine because I was afraid of him getting an
ear infection as in the past''. I have no idea how Kuna come up with
this conclusion, as I was never informed of the ear infection. This is
a great example of the deceptive practice that Dr. Kuna used in his
diagnosis of Taylor.
I took my son to the hospital on Monday morning around 6:00 a.m.,
and told them to call Dr. Kuna immediately. I called the hospital
before I left, and was informed that Kuna was scheduled to be on the
pediatric floor that morning. My child was not very well at all on
arrival at the hospital. I explained to them that I thought that he was
breathing heavier than usual, and that his eyes seemed strange to me.
The doctor writes in her report that he appears well hydrated and is
taking fluids well. She only spent at the most 15 minutes with us. She
also writes in her report that she checked Taylors neck. During the 15
minutes she never checked his neck. They poked my son numerous times
trying to take the 2nd blood test. After the first blood test they told
us the results were fine. They further stated that they could not
believe that results turned out to be OK. Because he looked ill they
were going to recheck the initial blood test. Taylor barely responded
to the numerous times that he poked in the arms while they were trying
to obtain blood. They actually had to send in another lab person to
take blood, because the second one could not draw any. They continued
to ignore my requests to have Dr. Kuna come look at him. But only in
the reports does it show that indeed he knew we were there at 8:50. My
husband carried my son upstairs to be admitted to the pediatric floor.
The nurses once again kept poking him numerous times in the arms to put
the IV in. I went over to Dr. Kuna's office to talk to him about Taylor
since he never showed up. His nurse told me that he was too busy to
talk to me at this time, and I should come back at 12:00. When I went
back to his room, my husband and I noticed that he was rocking and
acting like he was not looking at us. We kept asking the nurse to call
Dr. Kuna. One of the nurses stated that she noticed his eyes looked
funny upon his arrival to the pediatric floor, but, she did not say
anything. Dr. Kuna finally came over on the request of the nurse. He
checked his neck and Taylor cried. Then he took Taylor into get a
spinal tap. Immediately after the spinal tap, they had my husband carry
him back to his room. Dr. Kuna told us that our son had meningitis. He
left us standing there with just the nurse to take care of him. This is
the part I now find so disturbing. How could he just leave us there? He
stated he was in a hurry to get back to the office to take care of his
patients. Moments after Dr. Kuna departed, Taylor went into a seizure
that lasted 35 minutes. Dr. Kuna did not reappear until the last
minutes of the seizure. I questioned why we were being transferred to
St. Lukes hospital instead of Children's hospital. Dr. Kuna than
informed me that the same doctors were available at St. Lukes. Upon
arrival at St. Lukes, the staff fought for Taylors life until we
decided to take him off the machines and medicine on Feb. 25, 1998.
Dr. Kuna lied on the discharge summaries and he lied to the medical
board. There is great concern on his ability to provide quality care
for his patients. I am in great concern for the safety of other
children under this sort of care. After reviewing some of the records
and noting some of the mistakes, I am feeling tremendous guilt, because
I listened to Dr. Kuna against my better judgment. How could I be so
ignorant to trust this doctor with the life of my child? I thought that
he would watch out for my child knowing how they misdiagnosed him the
first time.
After Taylor's death I learned that there had been a letter of
admonition from the medical board regarding Dr. Kuna and the death of
another child. This letter really hit home for me. I wish that these
letters could be posted in the doctors office for patients to see. In
this instance, I feel that the letter could have made a big difference.
I also learned that he had been named in several lawsuits and many
other consumers had filed complaints with the medical board against
him. Had I known that he had gotten in trouble before, I would have
gone someplace else. Since joining PULSE, I know now that this problem
is nationwide, and many other children have died and been injured like
Taylor was due to medical errors, misdiagnosis, etc. I hope someday
that full disclosure will exist helped by mandatory reporting of
medical errors as I feel that there are children's lives at at stake.
Had I been informed, I know in my heart that there would have been a
much different outcome.
Thank you for allowing me to give you this written testimony.
______
Prepared Statement of the National Consumer Law Center
introduction
Mr. Chairman and Members of the Committee, the National Consumer
Law Center appreciates the opportunity to submit written testimony
regarding appropriation of funds for the Low Income Home Energy
Assistance Program for fiscal year 2001. This testimony is submitted on
behalf of our low income and elderly clients who face going without
food or medicine to avoid disconnection due to an inability to afford
utility service.
The National Consumer Law Center (NCLC) is a nonprofit corporation
dedicated to the interests of low-income consumers. Founded in 1969,
NCLC provides specialized legal support and consulting services to low-
income consumers, their advocates, government agencies and private
attorneys in all aspects of consumer and utility law. NCLC has helped
utilities, regulatory commissions and advocates design low-income
affordability programs and has published leading manuals and reports on
related law.\1\
---------------------------------------------------------------------------
\1\ Manuals and reports relating to utility service include Access
to Utility Service, Cap the Gap: Assuring Residential Customers Share
Benefits of Electric Industry Restructuring, The Regulation of Rural
Electric Cooperatives, A Guide to Low-Income Energy Efficiency and
Energy and the Poor: The Crisis Continues.
---------------------------------------------------------------------------
NCLC is a strong supporter of the Low Income Home Energy Assistance
Program (LIHEAP), as it is the primary safety net between low-income
consumers and disconnection of utility service. LIHEAP is designed to
target energy assistance to households most in danger of losing that
vital service. However, without adequate regular appropriations, LIHEAP
cannot get the job done. On behalf of our low-income clients, we urge
the restoration of LIHEAP funding to at least $1.5 billion in regular
appropriations for fiscal year 2001. This level of funding is slightly
less than the level appropriated for this program in fiscal year 1988
and far from the $2 billion level authorized to be appropriated for
this program in prior and upcoming years.\2\
---------------------------------------------------------------------------
\2\ 42 U.S.C. 8621(b).
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We also support additional emergency contingency funding of $300
million and advance LIHEAP appropriations for fiscal year 2002 of at
least $1.6 billion. This amount is still below the pre-1987 regular
appropriations levels, but would enable states to cover a larger
portion of the energy burden for eligible customers and increase energy
efficiency efforts to move households closer to energy self-
sufficiency.
While emergency funds are critical for responding to life-
threatening, brutal winters and summer heat waves, increasing the
regular appropriations for LIHEAP will allow the states to design more
solid programs for the upcoming year. This includes proactive, timely
and appropriately designed responses to crisis situations, as opposed
to reactive and potentially ill-timed responses due to the lag time
that comes with the dependence on the release of emergency contingency
funds. Delays in responding to heating and cooling crisis needlessly
jeopardize the health and safety of those Americans eligible for
assistance.
the need for restored regular liheap funding
Those that cannot afford to pay their winter heating bill often
face desperate choices. A 1999 survey of LIHEAP recipients in Iowa
revealed that when the heating bills were unaffordable, almost 21
percent went without medical care, 12.3 percent went without food and
19 percent went to bed early with lots of blankets.\3\ Analysis of
recent data from the U.S. Department of Energy, Energy Information
Administration show that in 1997, about 2.1 million households suffered
from loss of heat. All but 154,000 of the households were LIHEAP
eligible.\4\ The average period without heat was 3.3 days.\5\ The
consequences of disconnections include, health and safety risks
associated with alternative heat and lighting sources, such as kerosene
and candles; hunger and malnutrition; hyperthermia and hypothermia and
eviction and increased homelessness.
---------------------------------------------------------------------------
\3\ Preliminary results of a survey by the Department of Human
Rights, Community Action Agencies, Des Moines Iowa. The final results
are expected in May 2000.
\4\ Derived from 1997 Residential Energy Consumption Survey (RECS),
database files, Energy Information Administration, U.S. Department of
Energy, Washington, DC. 1999.
\5\ Id.
---------------------------------------------------------------------------
Census statistics also show a widespread need for the LIHEAP
program.
HOUSEHOLDS ELIGIBLE FOR LIHEAP OUT OF 91,993,582 TOTAL HOUSEHOLDS IN THE
UNITED STATES
------------------------------------------------------------------------
Percent
Proverty level Number of total
households households
------------------------------------------------------------------------
Greater of 60 percent SMI \1\ or 150 percent of 24,136,925 26.0
poverty.......................................
150 percent poverty or below................... 18,718,748 20.0
125 percent poverty or below................... 14,796,445 16.0
110 percent poverty or below................... 12,335,430 13.4
------------------------------------------------------------------------
\1\ State Median Income.
Source: Compiled from U.S. Dept. of Health and Human Service, LIHEAP
Division of Energy Assistance/OCS/ACF table on number of all low-
income households, by census region and state based on 1990 Census
data.
At its peak, regular, non-emergency, funding for LIHEAP was $2.1
billion in 1985. Since then, regular block grant funding has been cut
back to $1.1 billion in fiscal year 1999 and 2000. Consistent with the
cutback in funding is the reduction of the number of households served.
According to the Administration for Children and Families, U.S.
Department of Health and Human Services, the number of federally
eligible households using LIHEAP assistance dropped from 7.5 million
households in 1981 to 4.4 million households in 1996.\6\
---------------------------------------------------------------------------
\6\ U.S. Department of Health and Human Services, Administration
for Children and Families, September 1999, ``LIHEAP Home Energy
Notebook for fiscal year 1997'', p. 27.
---------------------------------------------------------------------------
At the same time, the percent of LIHEAP recipients' home heating
bills covered by LIHEAP has been diminishing as the amount of
recipients' total heating bills has been increasing. In 1981, LIHEAP
covered around 23 percent of the total bills and since 1987, this
percentage has steadily dropped from 19 percent in 1987 to 8 percent in
1996.\7\ At the same time total home heating bills have increased in
current dollars from $7.0 billion in 1981 to $7.9 billion in 1987 to
$10.6 billion in 1996.\8\
---------------------------------------------------------------------------
\7\ Id at 29.
\8\ Id at 29.
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Who is hit hardest by the reduction in LIHEAP funding? It is
estimated that 43 percent of LIHEAP eligible households have
children.\9\ A recent survey by the National Energy Assistance
Directors Association released in September 1997, showed that of the
1.2 million households that lost LIHEAP assistance between fiscal year
1995 and fiscal year 1997, 313,000 had at least one elderly member and
156,000 had at least on disabled member.
---------------------------------------------------------------------------
\9\ Oak Ridge National Laboratories, ``The Scope of the
Weatherization Assistance Program: Profile of Population in Need''
March 1994. p. xii.
---------------------------------------------------------------------------
LIHEAP recipients also tend to be on the low-end of the poverty
scale. For example, in fiscal year 1995, around 40 percent of
households that received assistance were under 75 percent of the
poverty level.\10\ The proportion of energy costs to household income
is called the energy burden. In 1995, NCLC completed a study that
illustrated the disparity in energy burden between average residential
and low-income households. We found the burden for the average
residential household is 3.8 percent, while low-income households pay
far more. Households receiving welfare assistance paid an average of 26
percent of their income on energy, Social Security recipients paid
around 14 percent and minimum wage households paid around 12
percent.\11\
---------------------------------------------------------------------------
\10\ U.S. Dept of Health and Human Services, Report to Congress for
fiscal year 1995: Low-Income Home Energy Assistance Program, p.30,
Table 12.
\11\ National consumer Law Center, ``Energy and the Poor: The
Crisis Continues,'' January 1995, chpt. II.
---------------------------------------------------------------------------
liheap can move households toward self-sufficiency
LIHEAP is a block grant that targets assistance to low-income
households who pay a high proportion of household income on home
energy, assists eligible families in crisis situations, and among other
things, provides low-cost weatherization to reduce household energy
costs.\12\ Increased funding for LIHEAP could work towards reducing
dependence on energy assistance in the first place. As noted by Vicky
Mroczek, Chief of the Office of Community Services, Ohio Department of
Development and the Director of Ohio's LIHEAP program: Reduction in
energy assistance dependence over time is self-evident with respect to
weatherization, but I think it's also true on the bill assistance side.
When someone goes into debt to maintain utility service, there are
costs or other needs that go unmet. When someone owes the utility money
over a long period, ratepayers bear that expense, too. An unpaid final
utility bill on a credit report impinges on a person's ability to buy
or rent housing; sometimes it can show up when a potential employer
does a background check. Loss of utility services also affects
education performance due to excessive moving or unhealthy conditions
in the home.
---------------------------------------------------------------------------
\12\ 42 U.S.C. section 8624(b).
---------------------------------------------------------------------------
emergency contingency liheap funds
Emergency contingency funds are a critical resource in times of
crisis, but should not be counted as part of the overall amount of
funding a state has to plan a program. Emergency contingency funds are
released only after the emergence of a full-blown crisis, which may
arise after the program has shut down for the season. Maintaining
current funding levels for LIHEAP regular and emergency contingency
funding in lieu of restored regular funding will continue to place
vulnerable low-income and elderly households in potentially life-
threatening situations time and time again. A more rational approach
would be to increase the current level of the regular funding so that
programs can effectively plan ahead for crisis situations to mitigate
the danger to safety and health.
the private sector
Fuel funds, a form of non-federal energy assistance, play an
important role in helping those Americans in dire need of energy
assistance; however, these funds are only a small fraction of the
LIHEAP. The National Fuel Funds Network estimates that in 1998, around
$88 million in non-federal energy assistance was raised nationally.
These private sector funds are critical, but simply not large enough to
provide the amount of energy assistance to eligible Americans as the
LIHEAP and cannot fill the gap left by reduced levels of regular LIHEAP
funding.
conclusion
We urge the restoration of LIHEAP assistance to, at a minimum, $1.5
billion in regular appropriations for fiscal year 2001 and $1.6 billion
in advance appropriation for 2002. Restored levels of regular funding
will enable state agencies design a stronger program for the upcoming
fiscal year. Finally, the need for LIHEAP assistance continues,
especially as states implement welfare reform and, as demonstrated this
past winter with the home heating oil price crisis, inadequate funding
levels place the health of financially vulnerable families in jeopardy.
______
Prepared Statement of the National Alliance for the Mentally Ill
Chairman Specter, Senator Harkin and members of the Subcommittee, I
am Jim McNulty, of Bristol, Rhode Island, a member of the Board of
Directors of the National Alliance for the Mentally Ill (NAMI). I am
pleased today to offer NAMI's views on the Subcommittee's fiscal year
2001 bill that are of tremendous concern to people with serious brain
disorders and their families.
who is nami?
NAMI is the nation's largest national organization, 210,000 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.
Like so many NAMI members, mental illness has directly affected my
life. In 1986, I was first diagnosed with bipolar disorder, also known
as manic-depressive illness.
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. From NAMI's
perspective, this progress was confirmed for all Americans through two
watershed events in 1999--the White House Conference on Mental Health
on June 7 and the release of the Surgeon General's Report on Mental
health on December 13. Taken together, these two events brought
together national leaders and the most comprehensive scientific report
ever to substantiate what we have been saying for years--that severe
mental illnesses are brain disorders that are treatable. As the Surgeon
General noted, current success rates for treating schizophrenia are
near 60 percent. Likewise, the success rate for bipolar disorder has
risen in recent years and now approaches 80 percent. For major
depression, the rate has climbed to nearly 65 percent. These recent
advances would not have been possible without substantial investment in
biomedical research directed to the most complex organ in the human
body, the brain.
severe mental illness research at the nih
The year 2000 marks the end of the Decade of the Brain--an
initiative that grew out of the leadership of your colleagues former
Senator Mark Hatfield of Oregon and the late Senator and Governor
Lauton Chiles of Florida--it is important for us to put into
perspective the gains we have witnessed in brain science that have
benefited people with serious brain diseases such as schizophrenia and
other severe mental illnesses. We also need to plan for the future
gains that are so necessary.
I noted earlier that severe mental illnesses are often quite
effectively treated. In fact, tremendous advances in treatment of
severe mental illnesses occurred during the last ten years, the Decade
of the Brain, from the introduction of Prozac and Clozapine and other
new drug discoveries that have virtually revolutionized mental illness
treatment. Today, many more consumers, patients with serious mental
illnesses, stand able to take charge of their lives, to be productive,
to enjoy recovery, because of these treatment advances.
But we should not underestimate how much more must be learned about
the brain regions involved in these serious mental disorders, the
molecules at the roots of the terrible symptoms, and the genes that
lead to vulnerability to these illnesses. The Decade of the Brain has
really only brought us to the threshold of discovery when it comes to
brain diseases such as schizophrenia, manic-depressive illness,
obsessive-compulsive disorder, childhood mental illnesses and others.
We are only now poised to fully probe and finally understand the
biological underpinnings of the most serious mental illnesses.
Treatment for mental illnesses, while impressive and comparable to
some of the best treatments in all of medicine, are still unacceptable
for patients, families, and our society. Many people with severe mental
illnesses find only incomplete relief from their symptoms; disability
is still all too commonly associated with these illnesses. In my case,
treatment for bipolar disorder has proven effective, but never for all
of the symptoms. Individuals with obsessive-compulsive disorder, a
brain disorder which has been pinpointed to specific higher regions of
the brain, still often fail to achieve much gain in treatment. For
children matters are worse because we know so little about the
illnesses as they emerge during development, and we know even less
about how to effectively and safely treat them.
The national need for severe mental illness research is most
starkly demonstrated by particularly terrible statistics. Our nation
stands in the midst of a virtual catastrophe: a suicide epidemic.
Suicide is the eighth most common cause of death in this country and
the fourth most frequent cause of life lost under age 65. Rates are
increasing among young men and the elderly. As it stands, 30,000
Americans will die by suicide this year, most of whom have a serious
mental illness. The most severe mental illnesses--schizophrenia and
bipolar disorder-disproportionately lead to suicide. Ten percent of the
2,000,000 U.S. citizens with schizophrenia are take their lives; about
half will make a suicide attempt at some point. Fifteen percent to 20
percent of the approximately 2,000,000 Americans with bipolar illness
will die by suicide.
That severe mental illness research ought to be a priority for our
nation is also demonstrated by data from the World Bank and World
Health Organization. Severe mental illnesses--major depression, bipolar
disorder, schizophrenia, and obsessive-compulsive disorder--account for
four of the top 10 most disabling illnesses in the world. These brain
disorders account for an estimated 20 percent of total disability
resulting from all diseases and injuries.
Mr. Chairman, the public health burden to our nation from severe
mental illnesses requires that research on these diseases be a high
priority, especially given the scientific opportunities that exist in
the brain sciences. Let me concentrate now on what we think are sound
goals for NIH and NIMH, respectively, so that we can bring the full
force of our research to bear on this most important health emergency.
nih investment: a call for increased funding and accountability
NAMI applauds your leadership in supporting increases for the NIH.
We urge the Subcommittee to follow the recommendations of the
scientific community and the Ad Hoc Group for Medical Research Funding
and increase overall funding for NIH by $2.7 billion (a 15 percent
boost) for fiscal year 2001, up to $20.5 billion. Such an increase
would keep Congress on pace to reach the bipartisan goal of doubling
NIH funding by 2003.
But increased resources are not the only important objective for
NIH: better accountability is also essential. NAMI applauds your
efforts to fairly boost NIH funding and limit disease-of-the week
approaches to appropriations. Nonetheless, we urge you to press NIH to
invest their resources according to public health need as well as
scientific opportunity, as the 1998 Institute of Medicine (IOM) report
on NIH priority setting called for. NIH must balance its investment
among diseases so that increases in the budget go preferentially to
address illnesses that are disabling and costly and have been
underfunded in the past.
It is obvious to NAMI that severe mental illnesses would, and
should be, a top research priority if public health burden is the
principal criteria by which public research dollars are allocated. Yet,
based on NIH's own recent estimates, $1.00 is invested in research for
every $6.86 in costs of AIDS, $9.96 in costs of cancer, $65.65 in costs
of heart disease, and $161.26 costs in schizophrenia. In other words,
15 cents is spent on AIDS research per dollar of costs, compared with
10 cents for cancer, two cents for heart disease, and less than one
cent for schizophrenia. This is obviously not a wise research
investment strategy for the United States.
nimh: the key to the cure for severe mental illnesses
For NIMH, we also applaud this Subcommittee's leadership,
demonstrated by your boosting its appropriations significantly in the
past few years and by nearly 15 percent in fiscal year 2000, up to its
current level of $978.4 million. For fiscal year 2001, NAMI urges the
Subcommittee to fund the NIMH up to the ``professional judgment''
recommendation of $1.169 billion. While NAMI applauds the President's
request to increase NIMH's budget by 5.9 percent, up to $1.031 billion,
we believe that the ``professional judgment'' recommendation needed in
order to increase the agency's success rate for reviewed grants to at
least 750 new and competing grants. NIMH is currently attracting more
research grant applications than any other institute due to the
leadership of the institute and the tremendous research opportunities
that exist in the neuroscience's and in severe mental illness research.
NAMI believes that we must ensure that this time of interest, strong
leadership, and research opportunity is taken--so that people with
serious brain diseases have the best hope for the future, for
themselves and for their families and future generations.
We urge you, Mr. Chairman, to help ensure that NIMH continues its
move to spend its taxpayer dollars wisely, with investments in basic
neuroscience and molecular biology that will undergird the new
treatment frontier for severe mental illnesses and also with strong
commitments to serious brain disorders directed towards pre-clinical,
clinical, and services research. NIMH should continue its efforts to
identify genes linked to severe mental illnesses; to fund and expand
clinical research into psychotic illnesses, serious disorders in
children, and in mood disorders; to continue the probe of the biology
of serious mental disorders including schizophrenia, mood, and anxiety
disorders.
NIMH should also use the tools of behavioral science to better
understand the expression and best treatment of severe mental
illnesses. However, NAMI strongly recommends that research in
prevention and psychosocial research should be redirected in order to
address problems associated with serious mental illnesses, consistent
with the recommendations of NIMH's own National Advisory Mental Health
Council. We agree with the recommendations of the Council that the
prevention research portfolio has all but excluded serious mental
illness research and instead focused on basic behavioral science issues
and or social problems such as adolescent relationships, divorce or
poor self-esteem. NAMI believes that we cannot let another five years
go by studying children who misbehave while we know so little about
serious mental illnesses in children and how to effectively treat these
disorders.
What research issues are most compelling for our members, the more
than 210,000 Americans facing a serious brain disorder? (1) More basic
research on the brain and higher brain functioning. (2) More pre-
clinical research on the genes, molecules, and brain regions involved
in severe mental illnesses. (3) More clinical research aimed at
understanding the best treatment for these serious disorders and
translating that research into practice. (4) More research aimed at
better understanding and treating these brain disorders in children.
(5) Research aimed at diminishing relapse and disability in severe
mental illnesses. (6) More research on how people with severe mental
illnesses best receive treatment and services. (7) An accountable and
responsible research investment strategy that will help the nation's
individuals with severe mental illnesses and their families, as well as
the country at large, which must shoulder the burden and costs of these
illnesses.
Finally, Mr. Chairman, NAMI would like to urge that NIMH's
colleague institutes, the National Institute on Drug Abuse (NIDA) and
the National Institute on Alcohol and Alcoholism (NIAAA) be directed to
work cooperatively with NIMH and the pressing public health crisis
posed by persons diagnosed with a severe mental illness who have a co-
occurring substance abuse problem. NAMI believes that a large and
growing body of scientific evidence is making clear that integrated
treatment, as opposed to parallel and sequential treatment, is the most
effective means of treating these co-morbid disorders. NAMI urges that
NIMH, NIDA and NIAAA should work in partnership to ensure that progress
continues in our efforts to better understand co-occurring mental
illness and chemical dependency.
samhsa and cmhs
Mr. Chairman, in addition to urging the Subcommittee to support
increased funding for brain research, I would also like to note the
importance of federally funded mental illness services through the
Center for Mental Health Services at SAMHSA. Federal support for
community-based care is a critical resource for people with the most
severe mental illnesses. With many states reducing their psychiatric
hospital beds and a growing number moving toward managed care systems,
the federal investment in community-based care continues to grow in
importance. For example, funding for the Mental Health Block Grant
(MHBG) now constitutes as much as 40 percent of all non-institutional
services spending in some states.
In the President's fiscal year 2001 budget proposal, a $60 million
increase is proposed for the MHBG (up from its fiscal year 2000
appropriation of $356 million, to $416 million). While NAMI is
extremely grateful for the $68 million increase that the Subcommittee
enacted for fiscal year 2000, the reality is that this boost in
resources is not enough to keep pace with the continued widening of
gaps in the public mental illness treatment system in many states. 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: the growing number of homeless adults on our nation's
streets who receive no treatment services, well publicized tragic
incidents involving individuals with severe mental illness who are not
accessing adequate treatment services and the growing trend of
``criminalization'' of mental illness and the stress it is placing on
state and local jails and prisons.
The causes of these growing gaps in the services are varied and
complicated: the trend toward privatizing state Medicaid programs
through contracting with private managed care firms, cuts in Medicaid
Disproportionate Share Hospital (DSH) funding and expansion of the
mission of public mental health programs beyond serving the most
severely disabled consumers. Moreover, in recent years state mental
health agency budgets have been under increasing pressure as a result
of forces beyond their control. Among these forces are restrictions on
eligibility for SSI and SSDI for people whose disability is based in
part on drug abuse or alcoholism and a 1997 U.S. Supreme Court decision
allowing states to commit sexually violent predators to state
hospitals.
In addition to supporting the Administration's proposed increase,
NAMI further recommends that the Subcommittee target all additional
funds for the MHBG in fiscal year 2001 to state and local evidence-
based, outreach-oriented service-delivery models for persons with
severe mental illness in the community. In particular, NAMI urges that
any increase in MHBG funding be directed to assertive community
treatment, including the Program of Assertive Community Treatment, or
PACT. PACT programs use a 24-hour, seven day-a-week, team approach that
delivers comprehensive treatment, rehabilitation and support services
in community settings. High-quality PACT programs are typically
implemented at a cost that is significantly less than placing an
individual in a jail, a residential treatment program or a hospital.
PACT is especially effective in serving persons who are the most
treatment resistant, persons with a co-occuring mental illness and
substance abuse disorder and persons who are high users of inpatient
hospitalization services.
In addition, NAMI recommends that the Subcommittee consider
requiring states to report an unduplicated count of persons served by
diagnosis, age and services consumed using the targeted initiative MHBG
funds. NAMI is also concerned that the Substance Abuse Treatment and
Prevention Block Grant is not currently supporting programs serving
persons dually diagnosed with mental illness and addictive disorders.
As I noted above, evidence-based research, as confirmed by the NIH,
verifies that integrated treatment, as opposed to parallel
collaborative or sequential approaches, is the most effective model for
serving persons with a dual diagnosis. NAMI therefore recommends that
the Subcommittee direct SAMHSA to allow states to use funding from both
programs to promote integrated treatment services for persons with co-
occuring mental illness and addictive disorders.
NAMI is pleased that the President's fiscal year 2001 budget
proposes another $5 million increase for the PATH program (up from its
current $30 million, to $35 million). PATH is a formula grant program
to the states to support local programs serving homeless persons with
severe mental illness. This increase in PATH funding will help
communities all across the country increase access to treatment and
supports for the growing number of homeless with severe mental
illnesses.
Mr. Chairman, as you know, the President's fiscal year 2001 budget
proposes a new unauthorized line-item as part of the CMHS's programs--
Targeted Capacity Expansion (TCE). According to CMHS's own
justification for this request, this new $30 million is for undefined
prevention and early intervention services for persons who are not
diagnosed with a severe mental illness who receive services in ``non-
mental health settings.'' While NAMI recognizes that such a new program
could offer benefit to many communities, we believe a more pressing
public health concern is the alarming trend of ``criminalization'' of
severe mental illness.
NAMI therefore urges that instead of establishing a new TCE line
item within the CMHS budget, the Subcommittee instead direct these
funds to a new initiative within the agency's Knowledge, Development
and Application (KDA) program on criminalization. Such a program should
be directed toward innovative state and local programs that (1) divert
mentally ill, non-violent criminal defendants and convicts into
treatment programs, (2) replicate successful models such as mental
health courts, and (3) train police officers in how to appropriately
interact with suspects with severe mental illnesses. NAMI is making a
similar request to your colleagues at the Commerce-Justice-State
Appropriations Subcommittee for a program of similar scope and purpose
at the Bureau of Justice Assistance.
In January, The Charlotte Observer ran a five-part investigative
series that reported since 1994, at least 35 people with mental or
developmental disabilities have died under questionable circumstances
while under the care of public and private mental health facilities in
North Carolina. Deaths were attributed to suicide, murder, neglect,
scalding, and falls, and most went unnoticed by the agencies authorized
with investigating such deaths. NAMI recommends that resources be
targeted to fund Protection and Advocacy agencies to investigate
questionable deaths and serious injuries, like those deaths in North
Carolina that have resulted from restraint abuse.
Unfortunately, the Charlotte Observer series is just one of several
investigative media reports over the last year that have exposed
systemic failures to provide adequate treatments and services to
individuals with severe and persistent mental illnesses. The Los
Angeles Times, The New York Times, The Hartford Courant, and The
Orlando Sentinel have revealed a pervasive pattern of neglect by state
mental health systems. The need for further investigation, a system of
accountability and mandatory reporting of deaths and serious injuries
will help ensure that individuals with mental illnesses don't lose
their lives in the very places designed to help them.
dol and ssa
Finally, beyond the NAMI's traditional concerns with NIMH and CMHS,
I would like to note two other departments under the Subcommittee's
jurisdiction that are of concern to NAMI--the Department of Labor (DoL)
and the Social Security Administration (SSA). With regard to DoL, NAMI
would like to go on record in support of the Administration request to
establish a new Assistant Secretary position for disability policy. At
SSA, NAMI would like to express our strong support for full
implementation of the Ticket to Work and Work Incentives Improvement
Act (TWWIIA) and fiscal year 2001 funding for the new work incentives
planning and outreach program. NAMI would like to thank you for your
strong support for TWWIIA last year. Enactment of both these proposals
will help ensure that progress is made in addressing the barriers to
work that still leave more than 80 percent of adults with severe mental
illnesses unemployed and out of the economic mainstream.
conclusion
Mr. Chairman, thank you for the opportunity to offer NAMI's views
on fiscal year 2001 funding for programs of critical importance to
people with serious brain disorders. NAMI looks forward to working with
you in the coming months to educate both the general public and your
colleagues in Congress about the critical importance of investment in
biomedical research and improved services for people living with severe
mental illness.
______
Prepared Statement of the American Public Transportation Association
The American Public Transportation Association (APTA) appreciates
this opportunity to testify on the fiscal year 2001 Labor, Health and
Human Services, Education and Related Agencies Appropriations bill.
About APTA
APTA's 1,270 member organizations serve the public interest by
providing safe, efficient and economical public transportation service,
and by working to ensure that those services and products support
national transportation, energy, environmental, community, and economic
goals. APTA member organizations include transit systems; design,
construction and finance firms; product and service providers; academic
institutions, and state associations and departments of transportation.
More than ninety percent of the people who use transit in the U.S. are
served by APTA member systems.
We submit testimony to this Subcommittee to make the point that
public transportation can make a difference in how people get to jobs,
health care, training, and other social services. According to the
Federal Transit Administration (FTA), 32 million senior citizens rely
on transit as their driving ability decreases with age; 27 million
people with disabilities depend on transit to maintain their
independence; 37 million people living below the poverty level often
cannot afford a car and use transit to reach jobs. There are 56 million
children under driving age, many of whom use transit to travel to and
from school and for after-school activities. Transit ridership has
grown by more than 15 percent over the past four years and annual
ridership exceeds the 9 billion mark.
Overview
Mr. Chairman, we bring a message about the role public
transportation can and does play in providing services to millions of
Americans. We ask that the Subcommittee consider three issues of
particular importance to public transit. First, APTA requests that the
Subcommittee direct the Department of Transportation (DOT) and the
Department of Health and Human Services (HHS) to complete joint
coordination guidelines on human services transportation as soon as
possible. Second, we urge the Subcommittee to highlight the role that
public transportation can play in providing cost-effective access to
health care and to work--made better by improved coordination. Finally,
we urge the Subcommittee to continue to provide and encourage
flexibility with regard to HHS funding being used to pay for the
transportation costs of HHS clients--especially those individuals with
special transportation needs. Transit agencies have the expertise and
infrastructure to provide transportation, and we think that social
service agencies could save money on transportation service by working
with transit agencies. The Federal Government has already invested in
public transportation. Let's not pay twice by allowing separate special
purpose systems to be built and subsidized.
Mr. Chairman, transit is delivering. U.S. transit ridership was up
more than 4.5 percent in 1999.\1\ Ridership is on the rise in every
mode, including a 5 percent increase in demand response service.
Moreover, these vital services, which provide the only source of
mobility for individuals with disabilities and our elderly population,
are seeing a dramatic increase in areas all across America--both rural
and urban. Demand response services are on the rise in places like
Springfield, Illinois; Milwaukee, Wisconsin; Pensacola, Florida; Waco,
Texas; Fort Myers, Florida; Dallas, Texas; Miami, Florida; and
Baltimore, Maryland.
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\1\ APTA Transit Ridership Report, Fourth Quarter 1999.
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Background
According to the U.S. General Accounting Office (GAO), federal
efforts to streamline the delivery of human services transportation by
DOT and HHS began as early as 1986 with the establishment of a
Coordinating Council.\2\ Over a course of years, the Council
successfully identified numerous barriers standing in the way of
transportation coordination. However, due to jurisdictional problems,
the Council was unable to fully respond to these barriers. Moreover,
even when the Council reached out to the States in the mid 1990's, the
majority of barriers that were identified were too general to be acted
upon with any significant federal response.\3\
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\2\ TRANSPORTATION COORDINATION: Benefits and Barriers Exist, and
Planning Efforts Progress Slowly. October, 1999. (Hereinafter, GAO
Report).
\3\ GAO Report, Page 3.
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In fiscal year 1997, report language first appeared in both the
Transportation and Related Agencies and Labor, Health and Human
Services Appropriations bills, calling for the development of joint
planning guidelines to specifically address the use of public
transportation in the delivery of human services transportation. APTA,
having worked with Congress to encourage this collaboration, was
pleased that the bills directed DOT and HHS to develop joint guidelines
for coordination of transportation services, including joint
identification of human services client transportation needs and the
appropriate mix of transportation services to meet those needs; the
expanded use of public transit services to deliver human services
program transportation; and cost-sharing arrangements based on a
uniform accounting system for HHS program recipients transported by
paratransit systems.
Although the joint guidelines have not yet been released, we are
hopeful that DOT and HHS will be in a position to release a working
draft in the near future. Nevertheless, we again urge this Subcommittee
to direct HHS and DOT to complete their joint coordination guidelines
as soon as possible, and to consider the feasibility of involving other
federal agencies, such as the Department of Labor, in the process.
GAO Report Cites the Value of Transportation Coordination
The report issued by the GAO notes that transportation coordination
can have numerous benefits. It also recommends a number of ways that
DOT and HHS can better coordinate their activities. They include:
--requiring the Coordinating Council to issue a prioritized strategic
plan by a specific date.
--charging the Council with developing an action plan with specific
responsibilities.
--requiring an annual report from the Council on its major
initiatives and accomplishments.\4\
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\4\ GAO Report, Page 20.
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APTA fully agrees with the recommendations made in the GAO report.
During this period of tight budget caps, every dollar dedicated to
human services transportation by transit agencies can be stretched
further if coordination is implemented at the federal level and
encouraged at the State and local level. These joint guidelines will be
invaluable in providing policy guidance for coordination activities by
transportation agencies and human service providers at the local level.
If we can't get the necessary guidance at the federal level, how can we
expect coordination at the local level?
TEA 21 Planning Provisions
We are pleased to note that the principal federal surface
transportation infrastructure investment law, the Transportation Equity
Act for the 21st Century (TEA 21), includes numerous provisions that
deal specifically with the importance of coordination of transportation
activities. First, the bill requires DOT to encourage metropolitan
planning organizations in developing local transportation plans to
coordinate the design and delivery of transportation services by all
entities receiving federal funds for transportation purposes. Another
TEA 21 section requires government agencies and nonprofit organizations
receiving assistance from government sources other than DOT for non-
emergency transportation services to coordinate the design and delivery
of transportation services. The law also requires transportation plans
to be consistent with air quality goals under the Clean Air Act.
Clearly, transportation services are coordinated with many federal
programs to improve overall efficiency.
public transportation provides affordable access to non-emergency
health care
Mr. Chairman, we continue to stress the importance of coordinating
transit service with other government functions because of the great
potential for saving tax dollars at all levels of government. To lower
costs, non-driving outpatients may travel to health care by transit.
The alternative may be expensive taxi or ambulance service. Rather than
using paratransit services (which can cost 10 times the amount of
traditional transit fares),\5\ physically able clients can save
themselves and human services agencies significant money by taking
other types of public transportation. For example, across the nation,
transit vans carry thousands of people to and from dialysis treatment,
saving as much as $200 to $400 per trip as compared to specialized
medical transportation services.
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\5\ GAO Report, Page 7.
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During the past decade, transit systems have made it increasingly
possible for transit services to be available to all Americans.
Wheelchair accessible buses increased from 40 percent of the fleet in
1990 to 77 percent of the fleet in 1999. Similarly, commuter rail
operators reduced the number of non-accessible rail cars by more than
half over the same period. Moreover, virtually all fixed route bus
service is now accessible to individuals with disabilities.
In 1997, the Health Care Financing Administration estimated that it
was spending approximately $1.2 billion annually in non-emergency
medical transportation. Since then, many state Medicaid offices have
found waste, fraud and abuse within their transportation systems and
have improved the delivery of transportation services at a reduced cost
by coordinating with local public transit operators. In fact, 20
percent of the nation's Medicaid rides are now on public transit.
According to the FTA, in four major programs--Medicare, Medicaid, Food
Stamps, and Unemployment Compensation--each dollar invested in low-cost
mobility services reduces the transportation cost of these programs by
approximately 60 percent.
public transportation delivers people from welfare to work
Transit Provides American's Access to Jobs; Employers Gain Access to
New Talent
During the late 1990's, Congress and the 50 States took positive
steps to get people off welfare and into the workforce. At the same
time, a healthy economy has created thousands of new jobs. However, due
to America's changing landscape and the growth of suburban sprawl, many
of these new jobs are located in the suburbs. How can we bring people
who live in central cities, many of whom have no automobile, out to
where the jobs are? Public transportation agencies, in coordination
with State and local social service agencies and the private sector,
have responded to the challenge.
One of the best examples of a successful access to work program
(and the value of coordination) is New Jersey Transit's ``WorkPass''
Program--a comprehensive transportation service and educational program
developed to assist public and non-profit agencies in their efforts to
move people from welfare to work. The program has provided assistance
to more than 50 public and non-profit organizations, including county
welfare agencies, Medicare agencies, and other social service
organizations who offer public assistance for transportation to jobs,
medical assistance and childcare. Partnering with the New Jersey
Department of Transportation as well as the State's human services
agency, New Jersey Transit was able to have a working program within
one month, and more than 5,000 monthly passes and one-way tickets are
purchased by WorkPass members each month. The transit agency notes that
the success of the program is due to the partnerships it has formed and
its ability to adapt to the different agencies seeking its services.
WorkPass is more than just a pass sales program--it has a
comprehensive training program which has trained more than 500 welfare
and other social service agency representatives. These representatives
are taught to read schedules, determine fares and accessibility and
provide special transportation services to their clients. New Jersey
Transit provides each member with a resource center stocked with
schedules, maps, fare charts and other transit information. WorkPass
provides participants with access to job training and education,
employment opportunities, medical visits, and childcare--all while
learning the valuable commuting skills they need to succeed when
employed.
The cost savings as a result of this program have been tremendous.
Under the WorkPass Program, instead of providing their clients with a
$6 per diem, welfare agencies reduce transportation costs by using bus
and rail monthly passes. County welfare agencies are saving between 50
percent--60 percent on each WorkPass participant--an estimated $2
million saved in transportation costs for its members.
More Coordination Needed To Deliver People from Welfare to Work
Mr. Chairman, the successful New Jersey program is representative
of the commitment the entire U.S. transit industry has put forth in the
effort to assist individuals making the difficult transition from
welfare to work. In October 1998, an APTA Access to Jobs Task Force was
created to help coordinate and assess APTA member welfare to work
activities. New services include new routes to employment locations
outside the existing service area; more direct service to reduce very
long trip times; late night and early morning service; so-called
reverse commute service; and shuttles from rail stations and the ends
of bus routes to dispersed job locations. The negative impact that
these extra efforts may have on transit budgets is easily outweighed by
the changes the programs have made in people's lives.
APTA believes that an awareness of problems encountered by
organizations in their welfare to work activities may help other
agencies avoid the pitfalls that could reduce the effectiveness of
their welfare to work programs. Therefore, we asked our member
organizations to describe some of the most common problems that they
have encountered in implementing welfare to work activities. Not
surprisingly, APTA's 1999 Access-To-Work Best Practices Survey Summary
Report reveals that throughout America, the lack of coordination is the
number one reason that some well intentioned welfare to work projects
have fallen short of their goals.
For example, lack of coordination has hampered programs in
Missouri. In St. Louis, there has been a lack of meaningful cooperation
with the training staffs of human services agencies. Also, City
Utilities of Springfield has experienced difficulty in coordinating
information from all the various social service agencies involved with
their welfare to work program. In fact, in order for them to put
together a comprehensive regional plan, the assistance of an outside
consulting company was required to gather all information. Moreover, in
Texas, transportation coordination with human services agencies is
sorely needed in the Fort Worth Transportation Authority's (The T)
attempt to identify employers willing to hire welfare recipients, and
to find strong candidates for certain jobs. Moreover, the transit
agency says that coordinating various funding sources has been quite
difficult--local social services partners are burdened with the task of
tracking separate data from separate Federal agencies, including DOL
and HUD. This requirement has been a major barrier in streamlining
funding for Tarrant County's welfare to work initiatives.
Some 94 percent of welfare recipients attempting to move into the
workforce do not own cars and must rely on public transportation to get
to work. And while 60 percent of welfare recipients live in central
cities, the majority of new jobs are in the suburbs. If we as a nation
wish to continue the positive trends in getting more people into
decent, productive employment, we must provide the necessary
coordination and guidance at the federal level to get them there. In
the TEA 21 section authorizing the Job Access and Reverse Commute
Program, DOT is required to ``coordinate activities with related
activities under programs of other federal departments and agencies.''
Eligible Access to Jobs projects financed under that section must be
``part of a coordinated public transit-human services transportation
planning process.'' \6\ Mr. Chairman, we need the help of the
Coordinating Council's joint guidelines in order to fully implement
this provision.
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\6\ TEA 21, Section 3037.
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Mr. Chairman, we've come so far in the last ten years with respect
to providing people on public assistance with access to decent jobs.
But without a concerted effort to improve coordination at the federal
level, there's a limit on the amount of services our transit agencies
and state DOT's can provide. Coordination is absolutely crucial to the
future success of the welfare to work initiative.
increased funds are required to maintain ada compliance standards
Since the enactment of the Americans with Disabilities Act, transit
agencies have made huge progress in their effort to ensure that all
forms of public transportation are accessible to individuals with
disabilities. But public investment for further on-vehicle lift, ramp
and station improvements must keep pace in order for transit agencies
to maintain Federal standards. More than 100 million trips were
provided on demand responsive public transit in 1999, at an estimated
total capital and operating cost of $1.4 billion. Accordingly, APTA
urges this Subcommittee to continue to provide and encourage
flexibility with regard to HHS funding being used to pay for the
transportation costs of HHS clients. This is also an area where the
joint guidelines would go far in ensuring HHS programs retain their
commitment to making adequate transportation resources available.
conclusion
In closing, Mr. Chairman, we again thank you for this opportunity
to convey our message about the critical role public transportation can
and does play in providing services to millions of Americans. We ask
that in developing the fiscal year 2001 Labor, Health and Human
Services and Education bill, the Subcommittee direct the Department of
Transportation and the Department of Health and Human Services to
complete the joint coordination guidelines on human services
transportation that have been requested by Congress. Second, we urge
the Subcommittee to highlight the role that public transportation can
play in providing cost-effective access to health care and to work--
made better by improved coordination. Finally, we urge the Subcommittee
to continue to provide and encourage flexibility with regard to HHS
funding being used to pay for the transportation costs of HHS clients--
especially those individuals with special transportation needs.
Once again, we appreciate your consideration of our views. APTA
would be pleased to provide you additional information to assist you in
your deliberations.
______
Prepared Statement of the National Council on Independent Living
Chairman Specter and members of the Senate Appropriations
Subcommittee on Labor, HHS and Education, the National Council on
Independent Living (NCIL) thanks you for allowing us to provide written
testimony regarding the great need to increase the funding in title
VII, Part C of the Rehabilitation Act of 1973, as amended, by $75
million over the next three years. This funding will allow states to
strengthen and expand the network of centers for independent living
throughout the country.
The National Council on Independent Living (NCIL) is the national
membership association of centers for independent living (CILs),
statewide councils on independent living (SILCs), people with
disabilities and organizations advocating for the rights of people with
disabilities.
CILs are community-based, non-profit corporations which are
governed, managed and staffed by a majority of people with
disabilities. CILs are non-residential organizations, advocating and
providing services that support the efforts of people with significant
disabilities to live more independently in their own homes, within our
communities.
Currently, there are 340 CILs, with more than 224 satellite
locations. Of these, 229 CILs and 44 satellites are funded with the $45
million dollars authorized through Title VII-Part C of the
Rehabilitation Act of 1973. The balance are supported with state funds.
A center's service area may be one county or a dozen. According to
the Rural Institute on Disabilities, CILs cover an average of 5.7
counties. Today, 60 percent (1,911) of our nation's counties receive
service from a CIL. This figure is deceiving, however, because a single
center may have the task of providing services to an area the size of
Pennsylvania.
NCIL is asking that the Senate Appropriations Committee make a
strong commitment to independent living. You can do this by increasing
funding for CILs by $75 million over the next three years.
As described above, statewide independent living councils are
joining in the effort to secure additional funds for CILs. SILCs are
governor-appointed bodies which are directed by the Rehabilitation Act
to design a network of CILs. Working in conjunction with the state
vocational rehabilitation agencies, SILCs must develop plans which
address the needs of our unserved and underserved communities. This
plan is submitted to the Department of Education and summarized each
year for your review. The following are some of the findings from 1998,
when CILs were funded at about $40 million nationally. These figures do
not include Massachusetts, Connecticut, and Minnesota because of their
unique funding formulas.
First, who did we serve?
In 1998, CILs assisted 118,000 people with significant
disabilities. Of these, 35 percent were from minority groups, which
significantly exceeded the percentage of minorities in the nation as a
whole (29.7 percent according to the Census Bureau). One might ask what
would contribute to a success rate that makes CILs the envy of many
service providers. Perhaps it is because over 28 percent of center
employees are also members of minority groups.
In the introduction, you were informed that CILs must be run by
people with disabilities. In 1998, almost 66 percent of the staff were
people with disabilities, including 72 percent of the decision-making
positions. When we say 19consumer directed', we mean it.
What about services?
If we were VISTA, we might brag about our 2 million hours of
community service. Or if we were a single services program, CILs would
claim to provide services over 760,000 times. But that isn't who we
are. CILs are about assisting people with disabilities so they can live
more independently in their communities.
In addition to responding to almost 340,000 requests for
information and referral, CILs provided over 54,000 individuals with
peer counseling services; 50,000 received assistance finding housing;
34,000 acquired personal assistance services; 33,500 attained
transportation services; over 54,000 individuals received independent
living skills training, and over 6,000 became employed. In addition,
literally tens of thousands of individuals received dozens of other
services from CILs, including assistance in moving out of costly
institutional settings such as nursing homes.
In 1998, CILs helped over 1,400 people get out of nursing homes AND
prevented over 14,500 from going into nursing homes. According to the
1998 State Data Book on Long Term Care Program and Market
Characteristics, the average cost of nursing home services across the
U.S. is $34,938/person/year. As you can imagine, there is a wide
variation in nursing home costs from state to state. In Washington, for
instance, the annual cost was $42,340.
Those who leave or avoid entering a nursing home are able to remain
in their communities because they receive personal assistance and other
community-based services. According to a 1999 report from the National
Conference of State Legislatures, the average cost for community based
services is $14,902 per person. In other words, when a center is able
to help a person move from a nursing home to community-based services,
they save taxpayers an average of $20,036. In 1998, CILs saved
taxpayers over $318 million. Think of it: A savings of $318 million AND
people remain in their own homes with their own families, as
contributing members of their communities.
Imagine the financial rewards in Alaska alone, where nursing homes
cost $92,520 per year for each resident while home health costs $33,
616. This amounts to a savings of $58,904 per person, per year.
Investing in CILs for independent living makes sense.--If the
federal CIL program were a seed or magnet project, it would claim that
with the $39,955,310 CILs received in 1998, they were able to attract
an additional $144 million outside of the funding from Title VII of the
Rehabilitation Act. This includes a variety of government, private
foundation, fundraising, and fee-for-service arrangements. In other
words, CILs make the taxpayers' money work for us--and for their
consumers.
Here's another interesting fact.--The average cost for serving an
individual at a CIL was $1,655. This amount is particularly startling
when it is remembered that this number does not include the thousands
of people who are served through information and referral, community
education and systems change activities not counted in the case service
records kept by CILs. These are individuals and groups who benefit from
the information and referral services provided as a core service at
every center and satellite, they are also individuals and groups served
through community training and awareness activities, and through the
systems change activities that result in sweeping improvements in the
way the needs of people with disabilities are met in general.
Thus far, this request has concentrated on statistics and data.
NCIL doesn't want to lose track of the fact that this appeal for
funding helps real people make real changes in their lives. Sometimes,
in the course of advocating for change, both the fiscal and personal
costs are lost.
However, these things we know:
--Additional stress will be put on our health care and housing
systems as baby-boomers age.
--Our nation is relying on institutions to address the needs of
people who are elderly and/or with disabilities.
--Institutions are expensive and much more restrictive than most
people need.
--Individuals, given a choice, will remain with their families and in
their own homes, participating in community activities.
--Oregon saved $278.3 million dollars between 1981 and 1996, by
serving 73 percent of eligible elderly people and those with
disabilities in the community.
--The personal attendant services that Kansas offers under Medicaid
waivers have saved the state $2,000 per person per year.
--Wisconsin's Community Options program, which offers personal
assistance and other services to keep people with disabilities
in the community, has saved the state as much as 25 percent of
the cost of nursing home placement for people at risk of
institutionalization.
In each of the above states, it is due to a strong independent
living movement that community-based services have been as successful
as the figures would indicate. This movement is initiated and fueled by
strong CILs. In Oregon and Wisconsin, it was through the efforts of
CILs that those states moved from the typical fragmentation of
services, to a single point of entry, thus streamlining service
delivery and significantly reducing costs.
That's what CILs do. Here are some examples of the personal impact
of their work:
A man in Fulton, Mississippi was injured in an automobile accident
and sustained a spinal cord injury. Like most who have this experience,
this gentleman was told that he would need 24-hour care in a nursing
home at a cost to the state of $30,000/year. A staff member from the
satellite center in Tupelo helped him find a wheelchair, counseled him,
and helped him get financial assistance from the state's Spinal and
Head Injury Fund. Today, this man is living with his elderly mother and
receiving four hours a day of personal assistance services at an annual
cost of less than $8,000/year.
A woman in New York was facing a life in a psychiatric center at an
annual cost of $137,000 due to pressure from her family and her own
lack of assertiveness. The center spent $212 to provide peer
counseling, advocacy, and other services to help her work with her
family and find her own apartment, where she now lives. She receives a
HUD rent subsidy of $2,712 per year.
The Hawaii Center for Independent Living has been helping a man who
experiences quadriplegia return successfully to his community. In
addition to providing independent living skills training and helping
him access assistive technology, the center has been working with local
vocational rehabilitation services and a small business called Custom
Computer Consulting to tie his lights, fans, phones, and other
appliances to his computer. Because of their efforts, he is going to
make it!
At the center for independent living in Hot Springs there was a
consumer who used a power wheelchair due to paralysis, was deaf and
visually impaired. This young woman was not very educated, had been
labeled as having behavioral problems, and her vocational
rehabilitation counselor had virtually given up on her. The center
began working with her using very limited signing skills, and taught
her typing and computer skills to improve her ability to communicate.
Everything about her changed. Suddenly she could express herself and
people understood her. She found a job that paid a competitive wage and
offers benefits such as medical insurance. This woman, who had been on
SSI all her life, is now a taxpayer. The center worked with her
approximately two months for a total cost of less than $5,000--less
than one year's worth of SSI payments.
CILs keep families together. In Milwaukee, Independence First
helped a single parent with quadriplegia. She contacted their assistive
technology program for ideas on baby care adaptations while she was
still pregnant. After her child was born she used the program to help
her get an adapted baby carrier for trips into the community, and ideas
for a lifting harness to help her get the baby onto and off of the
floor. The technology coordinator worked with Sharon and several county
agencies to assure that the child's care needs could be adequately met.
In 1994, a rural nursing home contacted the center in Tulsa,
Oklahoma. One of their residents was a young mother in her early
thirties who had incurred a traumatic brain injury as the result of a
car wreck. The injury had left the mother a paraplegic, with left-sided
paralysis. The young mother wanted desperately to leave the nursing
home and reestablish a relationship with her three small children. The
woman's physician and her own family members refused to help relocate
her to Tulsa. The woman didn't even have the $307 needed to pay for her
monthly medications. Nor did she have money for food, rental or
security deposits. After seven months, the center was successful in
locating resources within the community and moved this mother out of
the nursing home. Six years later, she is still living independently in
her own apartment and enjoying being a mother.
A young Maryland college student injured in an automobile accident
at 24 had been discharged from a rehabilitation center into a nursing
home in Hyattsville, Prince George's County, MD. A center for
independent living contacted the young man who was, ``convinced I was
going to be there forever.'' The center for independent living provided
peer support and information about resources he could utilize to
maximize his re-integration into the community. Today he is living in
his own apartment, attending the University of MD, and majoring in
computer science and graphic arts.
Why do we need $75 million?
Today, the CIL network reaches less than one percent of all people
with significant disabilities in the United States. While not every
person with disability needs a center's help, there remain vast areas
of the U.S. where no center exists at all. Forty percent (40 percent)
or 1,230 of our nation's counties receive no service whatsoever from a
CIL. Hundreds more receive only superficial coverage.
At the current rate of coverage (5.7 counties per center), The
Rural Institute on Disabilities estimates that we need at least an
additional 216 CILs. Some states have estimated that there should be at
least one ``fully-funded'' center for every 500,000 persons, or an
additional 185 CILs nationwide.
What is a ``fully-funded'' CIL?
Today, CILs are woefully underfunded. The average federally-funded
CIL receives approximately $163,285 to support the operations of the
center. Most statewide independent living councils believe that CILs
need a strong base--anywhere from $200,000 to $500,000 per center per
year--to do their job. The National Council on Independent Living
(NCIL) believes a center needs at least $250,000 to support day-to-day
operations, meet standards and assurances required by the
Rehabilitation Act, and address the goals of the community. The
Independent Living Research Utilization Program (ILRU) has found
limited funding to be the most common reason for the fiscal collapse of
CILs.
A $25 million increase in each of the next three years will fill
the gap. When we first raised this issue to you last year, several of
you expressed concern that the current funding formula, based solely on
population, would send most of the money to larger communities at the
expense of rural areas. This year, we are suggesting that each $25
million increment be divided roughly in half so that each state
receives an flat allocation of $250,000, plus an allocation based on
population.
What will be the impact of a $75 million increase over the next
three years? In Illinois, funding would increase from $1.5 million to
$3.7 million. The Illinois SILC will recommend that the funds be used
to address underserved inner-city people, as well as the unserved areas
in the four southern counties bordering Indiana.
Pennsylvania's funding would grow by $2.3 million over three years,
making it possible for CILs which have been operating at less than half
the recommended budget to finally reach their potential, and open long-
needed CILs in Du Bois and Johnstown.
In Florida, funding will increase from $1.8 to almost $4.4 million.
The Florida SILC will use the additional funds to not only shore up the
existing CILs, but also address the needs of the people in 27 of the
state's 67 counties who are receiving virtually no service at all.
In a rural state like Idaho, funding will grow from less than
$700,000 to almost $1.6 million. This will allow us to strengthen the
existing CILs, expand services to Coeur D'Alene and Caldwell, and set
up a center on an Indian Reservation.
Kentucky will increase it's budget from $490,000 to $1.7 million.
There are four fledgling CILs in Bowling Green, Lexington, Harlan, and
Covington which are operating on budgets of less than $70,000 each.
This increase would make it possible for those CILs to add the staff
they need to begin seriously addressing the independent living needs of
people in these communities.
In a large state like California, both urban and rural needs would
be addressed. CILs in San Diego and San Francisco are responsible for
such large populations (The San Diego center provides services to 11
percent of the state's population) that they have consumers within
their local communities who they cannot assist. This will greatly
increase their capacity to serve those folks plus allow for the funding
of satellites in the adjoining counties.
Arizona is among the most underserved states in the country. With
an additional $1.3 million, Arizona will be able to fully fund existing
CILs in Phoenix, Tucson, Prescott, and Yuma, plus add new CILs in
Flagstaff, Sierra Vista, and the Navajo Nation.
The Texas SILC has identified 18 unserved and underserved areas
throughout the state which they would cover with an additional $3.2
million, and Mississippi would turn their satellites in Tupelo,
Meridian, McComb and Greenville into CILs plus create a whole new set
of satellites.
In other words, an increase of $25 million over each of the next
three years will make it possible to fill gaps in a service system
which, in spite of proven success over the last twenty years, remains
pitifully inadequate.
Centers for independent living are a great bargain for America.
They keep people active and involved in their communities. They save
the taxpayer money. Given their track record, we know that CILs will
use that $75 million to double or triple those dollars. However, even
if they didn't, think of the changes and savings. At an average cost of
$1,655 per consumer for comprehensive IL services, they will serve an
additional 45,317 people. They will help another 1,630 individuals
relocate from nursing homes--and prevent another 16,000 from entering.
Funding centers for independent living makes sense: Common sense
and dollars and cents.
national council on independent living proposed incremental request
summary
The National Council on Independent Living proposes that there be
three annual increases in Part C of $25 million rather than one of $75
million. Each $25 million appropriation would be divided into two
allocations.
Approximately one-half of each year's appropriation would be
granted to states in $250,000 increments. (Note that $250,000
50 states = $12\1/2\ million. For appropriation purposes, the District
of Columbia and Puerto Rico have traditionally been considered states
and the territories have received somewhat less. For the purposes of
discussion, we are using a figure of $125,000 for each of the four
territories.) This means that each state, regardless of its size or
population will receive a base increase of $750,000 over three years.
Approximately one half of the $75 million will be appropriated to
states in this manner.
The remainder of each year's appropriation, an amount somewhat less
than $12\1/2\ million because of the allocations to DC and the
territories, will be granted to states based upon their percentage of
the nation's population. For discussion and projection purposes, we are
using the conservative figure of $11\1/2\ million.
As part of the appropriation process, NCIL requests that Congress
attaches spending authority language regarding the disbursal of these
funds, as follows:
--Each center for independent living (CIL) must have a base funding
level of at least $250,000. Therefore, before any new centers
are created, existing centers must receive at least $250,000 in
operating funds from the state and/or Federal Government.
Satellite centers may receive somewhat less based upon the
recommendation of the statewide independent living council
(SILC).
--Receipt of the additional Part C funds is contingent upon
maintenance of each state's funding effort. These additional
funds are intended to supplement, not supplant existing funds
generated in the state legislature for the operation of
centers.
--After each center is receiving an annual minimum base funding of at
least $250,000, all Title VII funds shall be distributed
following the directions set forth in the State Plan for
Independent Living.
Attached are two identical worksheets produced in Microsoft Excel
and in Word Perfect which show how the $75 million will be distributed
state-by-state over three years. The worksheet has seven columns:
--A list of the states and territories;
--Each state's annual distribution based upon its percentage of the
nation's population. As explained above, we are using a
conservative figure of $11\1/2\ million;
--Each state's distribution of $250,000, which we call equity;
--The 1 year total increase that each state is likely to be allotted
if we receive an incremental increase of $25 million;
--The 3 year total increase that each state is likely to be allotted
if we receive three incremental increases totaling $75 million;
--The funds currently allocated through Title VII Part C are in the
1999 total column;
--The 2003 total is each state's likely allotment if we are
successful in our efforts. The 2003 total represents a
combination of current (1999 total) and new (3 year total)
funds.
CENTER FOR INDEPENDENT LIVING PROGRAM--NCIL INCREMENTAL REQUEST SUMMARY
----------------------------------------------------------------------------------------------------------------
1 year 3 year
State Population Equity total total 1999 total 2003 total
----------------------------------------------------------------------------------------------------------------
ALABAMA................................ $183,507 $250,000 $433,507 $1,300,520 $505,225 $1,805,745
ALASKA................................. 26,061 250,000 276,061 828,183 602,952 1,431,135
ARIZONA................................ 181,997 250,000 431,997 1,295,990 536,293 1,832,283
ARKANSAS............................... 107,179 250,000 357,179 1,071,536 486,008 1,557,544
CALIFORNIA............................. 1,362,989 250,000 1,612,989 4,838,968 4,016,347 8,855,315
COLORADO............................... 161,674 250,000 411,674 1,235,022 697,758 1,932,780
CONNECTICUT............................ 141,308 250,000 391,308 1,173,925 486,008 1,659,933
DELAWARE............................... 30,937 250,000 280,937 842,810 486,008 1,328,818
FLORIDA................................ 611,229 250,000 861,229 2,583,687 1,801,120 4,384,807
GEORGIA................................ 310,706 250,000 560,706 1,682,118 915,563 2,597,681
HAWAII................................. 51,216 250,000 301,216 903,649 486,008 1,389,657
IDAHO.................................. 50,181 250,000 300,181 900,542 695,762 1,596,304
IOWA................................... 122,625 250,000 372,625 1,117,876 486,008 1,603,884
KANSAS................................. 110,674 250,000 360,674 1,082,021 566,935 1,648,956
KENTUCKY............................... 166,550 250,000 416,550 1,249,649 490,775 1,740,424
LOUISIANA.............................. 187,347 250,000 437,347 1,312,041 552,059 1,864,100
MASSACHUSETTS.......................... 262,079 250,000 512,079 1,536,236 954,181 2,490,417
MICHIGAN............................... 412,016 250,000 662,016 1,986,049 1,269,426 3,255,475
MINNESOTA.............................. 198,910 250,000 448,910 1,346,731 523,090 1,869,821
MISSISSIPPI............................ 116,369 250,000 366,369 1,099,107 486,008 1,585,115
MISSOURI............................... 230,494 250,000 480,494 1,441,483 1,060,757 2,502,240
MONTANA................................ 37,538 250,000 287,538 862,615 486,008 1,348,623
NEBRASKA............................... 70,633 250,000 320,633 961,898 789,481 1,751,379
NEVADA................................. 66,016 250,000 316,016 948,047 486,008 1,434,055
NEW HAMPSHIRE.......................... 49,533 250,000 299,533 898,600 486,008 1,384,608
NEW JERSEY............................. 342,808 250,000 592,808 1,778,423 1,010,158 2,788,581
NEW MEXICO............................. 72,704 250,000 322,704 968,111 551,100 1,519,211
NEW YORK............................... 782,525 250,000 1,032,525 3,097,575 2,305,881 5,403,456
OHIO................................... 481,139 250,000 731,139 2,193,417 1,417,781 3,611,198
OKLAHOMA............................... 141,438 250,000 391,438 1,174,313 672,259 1,846,572
OREGON................................. 135,527 250,000 385,527 1,156,580 554,713 1,711,293
PENNSYLVANIA........................... 520,878 250,000 770,878 2,312,633 1,534,881 3,847,514
RHODE ISLAND........................... 42,716 250,000 292,716 878,148 709,848 1,587,996
SOUTH CAROLINA......................... 158,481 250,000 408,481 1,225,443 486,008 1,711,451
SOUTH DAKOTA........................... 31,455 250,000 281,455 844,364 486,008 1,330,372
TENNESSEE.............................. 226,784 250,000 476,784 1,430,351 668,268 2,098,619
UTAH................................... 84,181 250,000 334,181 1,002,543 547,704 1,550,247
WEST VIRGINIA.......................... 78,874 250,000 328,874 986,621 904,979 1,891,600
WISCONSIN.............................. 221,045 250,000 471,045 1,413,135 651,358 2,064,493
WYOMING................................ 20,711 250,000 270,711 812,133 486,008 1,298,141
D.C.................................... 23,904 250,000 273,904 821,711 486,008 1,307,719
PUERTO RICO............................ 162,019 250,000 412,019 1,236,058 486,008 1,722,066
------------------------------------------------------------------------
NATIONAL TOTALS.................. 11,500,000 13,500,000 25,000,000 75,000,000 44,222,040 119,222,040
----------------------------------------------------------------------------------------------------------------
fact sheet--increased funding for centers for independent living
What is a Center for Independent Living (CIL)?
A CIL is a non-profit corporation, which assists people with
significant disabilities who want to live more independently. CILs are
managed and staffed by people with disabilities, are always located in
the communities they serve, and assist people with all types of
disabilities.
How do CILs assist people?
The foundation of CIL services is the peer relationship--people
with disabilities assisting other people with disabilities as role
models, mentors, and counselors. Each center is unique because it
offers services based upon the particular needs of its community. At
the same time, centers are alike in that they all offer core services:
information and referral, peer counseling, individual and systems
advocacy, and independent living skills training.
How many centers are there in the U.S.?
Currently, there are 340 centers for independent living, with more
than 224 satellite locations. Of these, 229 centers and 44 satellites
are funded through Title VII-Part C of the Rehabilitation Act of 1973
(as amended). A center's service area may be one county or a dozen.
According to the Rural Institute on Disabilities, CILs cover an average
of 5.76 counties. Today, 60 percent (1,911) of our nation's counties
receive service from a CIL.
What role do satellites play in the CIL network?
Satellites, sometimes called branch offices, are administered by an
existing center and fill a critical need in the independent living
network. Satellites make it possible for services and programs to be
provided in outlying areas while avoiding the overhead of a
freestanding, non-profit corporation. Some satellites have only one or
two staff while others have more to address the needs of their
communities. Costs for satellites vary, therefore, from state to state
and community to community.
What must CILs do to receive Title VII-Part C funds?
In addition to submitting a viable application in a statewide
competition, CILs must meet standards and assurances set by Congress,
as well as goals and objectives, which address the needs of their
communities. The assurances are fiscal and programmatic reporting
requirement, while each standard has indicators of compliance which
address the day-to-day operations of the center. Centers report
annually on their progress and are visited periodically as part of a
state and federal oversight process.
What is the current funding level for federally funded centers?
Current funding for Title VII-Part C of the Rehabilitation Act is
$43,692,496. This is an average of $163,285 per center and $97,821 per
satellite.
Are CILs a good investment?
You bet! Last year the Department of Education gathered information
from 295 of the centers. In addition to responding to almost 340,000
requests for information and referral, these centers provided over
54,000 individuals with peer counseling services; 50,000 received
assistance finding housing; 34,000 acquired personal assistance
services; 33,500 attained transportation services; and over 54,000
individuals received independent living skills training. In addition,
literally tens of thousand of individuals received dozens of other
services from centers, including assistance in moving out of costly
institutional settings such as nursing homes.
Why do we need more centers for independent living and satellites?
Today, the CIL network reaches less than one percent of all people
with significant disabilities in the United States. While not every
person with a disability needs a center's help, there remain vast areas
of the U.S. where no center exists at all. Forty percent (40 percent)
or 1,230 of our nation's counties receive no service whatsoever from a
CIL. Hundreds more receive only superficial coverage.
How many more CILs do we need?
At the current rate of coverage (5.7 counties per center), The
Rural Institute on Disabilities estimates that we need at least an
additional 216 centers. Some states have estimated that there should be
at least one ``fully-funded'' center for every 500,000 persons, or an
additional 185 centers nationwide.
What is a ``fully-funded'' CIL?
Today, CILs are woefully underfunded. As stated above, the average
federally funded CIL receives approximately $162,285 to support the
operations of the center. States have set funding targets ranging from
$200,000 to $500,000 per center per year. The National Council on
Independent Living (NCIL) believes a center needs at least $250,000 to
support day-to-day operations, meet the standards and assurances, and
address the goals of the community. The Independent Living Research
Utilization Program (ILRU) has found limited funding to be the most
common reason for the fiscal collapse of centers.
What level of support is needed for CILs?
Centers for independent living need an additional $75 million to
build a strong nationwide network of centers. This increase will bring
the total budget for Title VII-Part C to $120 million, a fraction of
what is expended for other programs assisting significantly fewer
persons. CILs have a proven record of accomplishment, distinguishing
themselves among consumers, advocates, and providers alike. Support for
CILs makes good sense!
______
Prepared Statement of the City of Newark, NJ
Mr. Chairman: Thank you for giving me the opportunity to submit
testimony on behalf of the City of Newark, New Jersey regarding two
innovative projects that are of importance to us: (1) the Children's
Health Care Services Center and (2) the Newark Museum Science Education
Project.
children's health care services center
The Children's Health Care Services Center will provide a
coordinated approach to offering health and social services to
uninsured/underinsured pregnant women and children between the ages of
0 through 5. The City's Department of Health and Human Services will
partner with other community organizations and hospitals to provide a
full spectrum of health, social services and mental health services.
There is a tremendous need in Newark for such comprehensive
services. The City of Newark has been designated by the Centers for
Disease Control and Prevention as a pocket of need for children. An
analysis of trends in the City of Newark reveals that 1/5 of Newark
resident births in 1996 were to teenage mothers (under age 20). Teenage
mothers have accounted for 1 in 5 Newark resident births from 1989
through 1996. Over one-half of Newark resident women who delivered in
1996 began pre-natal care in the first trimester of pregnancy. In
contrast three fourths of all New Jersey mothers giving birth in 1996
began pre-natal care in the first trimester. Since 1989 the percentage
of Newark mothers receiving pre-natal care in the first trimester has
generally declined for all age groups. In fact, the rate of mothers
giving birth in 1996 who received no pre-natal care was six times as
high for Newark (8.3 percent) as for the State as a whole (1.3
percent). By race, nearly 12 percent of black mothers in Newark and 3
percent of white mothers received no pre-natal care.
In 1996 the number of Newark resident infant deaths 80, a 14.3
percent increase over the 70 infant deaths in 1995. Notwithstanding
this one year increase, the number of resident infant deaths in Newark
decreased from a high of 189 deaths in 1989 to the current level. Neo-
natal deaths have been increasing over the past 8 years, from 52
percent of the total infant deaths in 1989 to 58 percent in 1996. The
leading cause of death for infants in Newark in 1996 is low birth-
weight. The second leading causes of death were congenital anomalies
and sudden infant death syndrome.
Other ailments that affect the health of Newark children include
pulmonary dysfunctions such as asthma and lead poisoning. As of
December 31, 1998, Newark had a caseload of 1,613 children under age
six with blood lead levels over 20 ug/dL. In 1998 an average of 25
percent of nearly 2,000 children tested had blood lead levels over 20
ug/dL.
The objective of the Newark Children's Health Care Services Center
is to positively impact on the health of Newark's children through the
development of a coordinated health care system that will allow the
City to bring health care services to the community.
Through the use of focus groups, the DHHS will assess and re-
evaluate Newark residents use of existing services. Focus groups will
be conducted to analyze barriers to services and residents utilization
rates. Based upon the analysis, the DHHS will design the Children's
Health Care Services Center as a consumer friendly service center.
At minimum, the Center will provide services that include, pre-
conception counseling, early pregnancy testing, pre-natal care,
substance abuse counseling and referral services, family counseling,
pediatric practice with related services including WIC, immunization,
nutritional counseling and case management services. Health education
will be offered to develop parenting skills and managing households.
Through the centralization of services, we believe that we can
increase access to the array of health and social services needed by
Newark residents to raise healthy children. The City seeks $2.5 million
in Federal support for this initiative.
newark museum
Newark is truly at a crossroad--we are a City with all of the
problems of many major urban centers, but we are also a City with vast
potential. We have begun to turn the corner--there is a renewed
vitality and sense of optimism in Newark.
The Newark Museum seeks $2.0 million to support its new Science
Initiative Education. The City of Newark has committed $1.7 million
dollars to date toward the preparatory collections care necessary to
make this initiative possible. Additionally, The Museum plans a $5
million dollar operating endowment fund based upon a public/private
partnership to assure adequate on-going support, of which $1.2 million
has been raised to date. Research has shown that the ongoing
maintenance cost of science galleries is several multiples of that of
art galleries.
The plan calls for the creation of a major permanent exhibition
based upon its natural science collection. The exhibition, called
Making Sense of the Natural World, will explore scientific phenomena
through natural history specimens and live animals. Museum audiences
will participate in mindful science learning through stimulating and
engaging experiences that integrate the collections, Dreyfuss
Planetarium and Mini Zoo. This gallery, along with the Museum's plan to
institutionalize cohesive science education programs parallel to its
distinguished art and culture programs, is the core of The Newark
Museum Science Education Initiative.
The cohesive science education at The Newark Museum will entail
greater use and dissemination of their science gallery, planetarium and
live animal resources, thus providing new learning opportunities for
individuals, families, schools, and community organizations. This
initiative also allows the Museum to safeguard the thousands of
scientific specimens, so critical to its success, in proper housing
both in the exhibition and in technologically advanced, environmentally
appropriate behind-the-scenes storage.
The Newark Museum is recognized as one of the nation's leading
cultural institutions. It is located in Newark, New Jersey's largest
city, and within Essex County, the State's most densely populated. The
Museum's constituency is economically and ethnically diverse,
reflecting the distinctive character of the city, northern New Jersey
and the metropolitan region. In 1998, The Newark Museum served an
audience of 462,000 children and adults.
The Newark Museum's natural science collections of 74,000 specimens
in the areas of geology, botany and biology are being utilized today in
programs that allow for participatory and inquiry-driven experiences,
to engage visitors in meaningful science learning. Science-related
programs draw more visitors to The Newark Museum than any other
offering, despite the fact that the science galleries have been closed
for more than a decade. Realizing the opportunity to attract larger
audiences and better serve Newark and New Jersey residents, the Museum
has embarked on a new science initiative. It will enable the Museum to
reopen the science galleries and builds upon the Museum's proven track
record of excellence in interdisciplinary arts and humanities programs.
The Newark Museum New Science Education Initiative: Reshaping Science
Education
In planning the new Science Initiative, Museum staff and Trustees
have been guided by the principles contained in Goals 2000 and by New
Jersey's recently adopted Core Curriculum Content Standards for K-12
education. Critical thinking, mathematical, and scientific
understanding will be fostered as visitors question, experiment,
compare, and analyze real specimens from the Museum's science
collections, and participate in planetarium and Mini Zoo programs
designed to effectively communicate complicated and abstract science
concepts.
The science plan will also include a Science Resource Laboratory
for teachers, which will provide them with a space to research and test
curriculum ideas for hands-on activities in the natural and planetary
sciences. Based on the results of research conducted with Newark
educators, these monthly multi-session and one-time in-service teacher
professional development workshops will provide teachers opportunities
to become more comfortable teaching science and meet the state-mandated
re-certification requirements. The same Science Labs will be used by
school classes and in after school and weekend programs to reinforce
science concepts that are introduced in Making Sense of the Natural
World, the projected new exhibition.
For high school students from Newark and other state urban
districts, the Science Initiative calls for a Science Career Ladder.
These innovative programs are designed to provide ``at-risk'' teens
with critical exposure to careers in science and to teach workplace
ethics and behavior. This builds upon an already successful YouthAlive
program at the Museum. In addition, the plan will provide a Science
Internship Program, which will offer students a year-long experience in
scientific research, collections management, and the planetary sciences
at The Newark Museum.
The New Natural Science Exhibition, Making Sense of the Natural World
This gallery, intended primarily for a family and elementary school
audience, will be one of the few in the country to combine the best of
natural history museums and science centers by marrying actual
biological, geological and botanical specimens with hands-on, inquiry-
driven activities.
In this exhibit, visitors will experience the wonder of nature's
diversity and then look at collections the way scientists look at them.
They will begin to learn that natural history specimens individually
and collectively provide volumes of information about science. They
will understand how ordering the natural world led to the realization
that the Earth is constantly changing and that life adapts to those
changes. Moreover, they will appreciate that evidence of those changes
is as close as their own backyard.
Recurring throughout the exhibit will be the concepts of bio-
complexities and dynamic geological forces as fundamentals of the
natural world. The museum's striking collections will be the vehicle
for explaining--making sense of- these concepts as they relate to
living and non-living systems, globally and locally.
The exhibition will be divided into five sections. The first is an
Introductory Gallery, called the Diversity Arc, in which visitors will
realize that by uncovering relationships within groups of specimens,
scientists have been able to order and make sense of the diversity
around them. Visitors will meet their video host at the first of
several stations that are located throughout the exhibit. The host is a
museum scientist who will guide visitors' observations and enhance
their understanding of the exhibit's concepts. The host is one of the
ways the exhibit will depict people as part of nature and interpreters
of it. It will serve to put the exhibit components into context for the
visitor.
In the second gallery, The Dynamic Earth: Forces of Change, sound
and light will give visitors the feeling of being present at the
beginning of the Earth. A short video will elaborate on the formation
of the planet, plate tectonics and climate. Video animation will be
used to communicate abstract geological concepts. Specimens will be
displayed that illustrate the products of geological activity, climate
change and glacial activity. Mineral and rock specimens will be chosen
for the stories they can tell. Fossils, such as Glossopteris, found on
today's widely separated continents, will show how tectonic forces
split the continent on which the fern once grew.
Next, the visitor will encounter Life Adapts to Change, which will
show the tremendous variety of environments on the Earth--the
consequences of where continents and oceans are located today, and
climate. Specimens from the African Savannah will show how different
species have adapted to a unique biome, the grassland, through color,
behavior and structure. The exhibit also contains an interactive
natural selection component explaining the process. The remainder of
the exhibit will illustrate two different kinds of adaptations to the
environment: structural and behavioral.
At this junction, visitors will have the choice of either
continuing to Collections: Tools of Knowledge or Diversity in Your
Backyard: New Jersey Highlands. In Collections: Tools of Knowledge,
visitors will discover that science is a dynamic, ongoing activity that
uses specimens and collections as tools to make sense of the natural
world. In this section, visitors explore how science is actually
conducted. Scientists will tell their own story of how they collect
data and analyze it, and there will be equipment which visitors can
manipulate in activities designed to mimic the work the scientists
perform. For most of the population, science is an abstract art, almost
like magic. This area of the exhibit will assign the tasks of the
scientist to the visitor, making the process of science much more
concrete.
The final, and largest, section is called Diversity in Your
Backyard: New Jersey Highlands, which will feature a re-creation, in
the form of a walk-in diorama, of an oak-hickory forest biome of the
New Jersey Highlands. It is a demonstration of how and why the
interdynamics of geology and biology creates an ecosystem. Using New
Jersey as a backdrop, this gallery will provide specific examples of
Dynamic Earth and Adapting to Change in a recreated environment of the
New Jersey Highlands. This will allow visitors to apply the complex
ideas introduced earlier to examples familiar to them and to make sense
themselves of the natural world. A tented ``field station'' will offer
opportunities for hands-on activities.
In closing, federal support is critical for each of these
initiatives. It is my hope that the subcommittee will find them worthy
of your support.
______
Prepared Statement of the University of Medicine and Dentistry of New
Jersey
The University of Medicine and Dentistry of New Jersey (UMDNJ) is
the largest public health sciences university in the nation. Our
statewide system is located on five academic campuses and consists of 3
medical schools and schools of dentistry, nursing, health related
professions, public health and graduate biomedical sciences. UMDNJ also
comprises a University-owned acute care hospital, three core teaching
hospitals, an integrated behavioral health care delivery system, a
statewide system for managed care and affiliations with more than 200
health care and educational institutions statewide. No other
institution in the nation possesses the resources which match our scope
in higher education, health care delivery, research and community
service initiatives with federal, state and local entities.
We appreciate the opportunity to bring to your attention our
priority projects that are consistent with the mission of this
committee. These projects are statewide in scope and include
collaborations both within the University system and with our
affiliates. Our research projects also underscore UMDNJ's commitment to
eliminating racial disparities in health care delivery. New Jersey,
with its small geographic size and its large diverse population, is an
idea site in which to conduct research and develop activities that will
address this important issue. The first of our priority initiatives is
the Child Health Institute of New Jersey:
UMDNJ-Robert Wood Johnson Medical School (RWJMS) has developed the
Child Health Institute of New Jersey as a comprehensive biomedical
research center focused on the health and wellness of children. At this
institute, biomedical researchers address the prevention and cure of
environmental and genetic diseases of infants and children. The Child
Health Institute is integral to the long-term plan for the enhancement
of research at RWJMS in developmental genetics, particularly as it
relates to disorders that affect a child's development and growth,
physically and functionally. The program will enable the medical school
to expand and strengthen basic research efforts with clinical
departments at Robert Wood Johnson University Hospital, in particular
those involved with the new Bristol-Myers Squibb Children's Hospital.
The CHI will build on a current NIH funding base at RWJMS and its
academic partners of more than $50 million with significant strengths
in genetic, environmental and neurosciences research at the medical
school and the associated joint research and advanced degree programs
with academic institutions and the pharmaceutical industry.
The Child Health Institute will focus research on the molecular and
genetic mechanisms that direct the development of human form,
subsequent growth, and acquisition of function. Broadly, the faculty
and students will investigate disorders that occur during the process
of development; to discover and study the genes contributing to
developmental disabilities and childhood diseases; to determine how
genes and the environment interact to cause childhood diseases; and to
identify the causes and possible avenues of treatment of cognitive
disorders found among conditions such as mental retardation, autism and
related neurological disorders.
Approximately half of the admissions to children's hospitals are
for genetic disorders, and the majority of these are the result of
genes interacting among themselves and with the environment.
Examples include autism, heart defects, diabetes and cleft lip.
Babies are five times more likely to have a cleft lip if their mother
carries a particular gene and smokes during pregnancy. Mothers with
this gene who don't smoke don't increase the risk for their child.
Preventing this class of clift lips is now possible through testing
mothers coupled with behavior modification.
Despite new therapies, asthma-related problems have risen by 50
percent over the past decade with hospitalization rates 4-5 times
higher for African Americans. Effective prevention and treatment will
require greater understanding of the molecular mechanisms that elicit
asthmatic attacks, and more understanding of the molecular reactions
mounted by cells once stimulated by environmental factors. Continued
exploration of the basic molecular underpinnings of injury reactions
will lead to more rational methods to prevent, minimize and treat
asthmatic reactions and deaths. Urban academic medical centers such as
RWJMS are at the epicenter of the current escalation in asthma and the
Child Health Institute is well positioned to address this critical
issue.
Development of the Child Health Institute will fill a critical gap
through the expansion, by new recruitment, of an intellectual base upon
which basic molecular programs in child development and health will
build. It is expected to cost almost $30 million for our building with
an additional $10 million endowment for programs. We are requesting an
appropriation of $5 million from the Federal Government to complement
$3 million already received from the Federal Government, $18 million
raised in the private sector and $10 million we expect to raise from
the State.
A second priority is the Gallo Prostate Cancer Center:
The Dean and Betty Gallo Prostate Cancer Center (GPCC) was
established at the Cancer Institute of New Jersey (CINJ) with the goal
of eradicating prostate cancer and improving the lives of men at risk
for the disease through research, treatment, education and prevention.
GPCC was founded in memory of Rep. Dean Gallo, a New Jersey Congressman
who died of prostate cancer diagnosed at an advanced stage. The purpose
of the GPCC is to establish a multi-disciplinary center to study all
aspects of prostate cancer and its prevention. The Cancer Institute of
New Jersey is a partnership of UMDNJ-Robert Wood Johnson Medical School
and hospital affiliates.
Prostate cancer is particularly devastating in New Jersey. With the
highest population density in the country, our state has one of the
highest prostate cancer rates in the nation. African-Americans
diagnosed with the disease are twice as likely to die from it. To help
eliminate this health disparity, GPCC is collaborating with
organizations such as ``100 Black Men'' in a prostate cancer initiative
that will make educational programs and cancer screenings available in
all 21 counties throughout the State.
GPCC unites a team of outstanding researchers and clinicians who
are committed to high quality basic research, translation of innovative
research to the clinic, exceptional patient care, and GPCC efforts will
be focused in four major areas: Basic, Clinical and Translational
Research; Comprehensive Patient Care; Epidemiology and Cancer Control;
and Education and Outreach.
GPCC scientists will investigate the molecular, genetic and
environmental factors that are responsible for prostate cancer
initiation and progression. Our researchers will develop appropriate
model systems that will facilitate the design and implementation of
novel strategies for prevention and treatment. GPCC will foster multi-
disciplinary efforts that will lead to the effective translation of
basic research, improved patient care and novel clinical trials.
Another goal of the GPCC is to understand the etiology of prostate
cancer susceptibility and to find effective modalities for prevention
of the disease.
The Cancer Institute of New Jersey has received $5 million in
federal funding over the last two years for the Gallo Prostate Cancer
Center. This important funding has enabled us to establish a world-
class program in prostate cancer research that includes publications in
prestigious national journals. CINJ has used its findings to leverage
additional research dollars for individual investigators from such
agencies as CapCure, the Department of Defense and several private
foundations. Top investigators have been recruited to initiate programs
in prostate cancer research through our education and pilot grant
programs.
Additional federal funding is being sought this year to build on
our basic research in prostate cancer and to support the development of
technological approaches to test new methods of prevention and
treatment. This additional funding will also allow us to enhance our
treatment of patients with prostate cancer through several new clinical
trials for patients at all stages of the disease. We seek $2 million in
federal funding to enhance the research, education and cancer care
programs of the Gallo Prostate Cancer Center at our New Brunswick
facility and to expand these programs statewide.
Another priority this year is to establish a statewide General
Clinical Research Center:
New Jersey is the most densely populated state in the nation and
hosts some 175 healthcare companies within its borders. Yet, New Jersey
has failed to attract large amounts of clinical research dollars
because there is no General Clinical Research Center within the state.
As a consequence, patients in the state lack adequate access to the
latest in clinical research studies. UMDNJ is well positioned to
reverse this trend and requests federal funding to provide the
infrastructure to compete more effectively for both NIH and
pharmaceutical research dollars.
The UMDNJ-Robert Wood Johnson Medical School Clinical Research
Center (CRC) is a 16-bed dedicated clinical research facility located
in New Brunswick, New Jersey. New Brunswick is known as the ``health
care city'' and is home to many of the state's major pharmaceutical
firms. Robert Wood Johnson Medical School is consistently ranked among
the most diverse in the nation.
As such, the University can make significant contributions in the
clinical research training of under-represented minorities enrolled in
medical, nursing, dental, pharmacy, public health, dietary and other
advanced degree programs across the state. The medical school is home
to the Cancer Institute of New Jersey, the Child Health Institute of
New Jersey and other nationally recognized centers of excellence. We
are well positioned to uphold NIH policies regarding the inclusion of
women, minorities and children in clinical research studies.
Robert Wood Johnson Medical School has a well-established research
environment that provides insight into the basic mechanisms of disease,
innovative approaches to patient care that leads to the etiology and
pathogenesis of disease, and patient care outcomes. Scientists in the
basic and clinical departments continue to make nationally recognized
contributions in their areas of expertise. Researchers within the
medical school have been in the forefront of medical discoveries,
including advances in Parkinson's disease, Lyme disease, disorders of
sexual dysfunction, epilepsy, prostate cancer, psoriasis, cardiology,
and obesity. In addition to broad-based programs at RWJMS' three
campuses in Piscataway, New Brunswick and Camden, the CRC is committed
to expanding its research programs by collaborating with other schools
within the UMDNJ system as well as with affiliated institutions. This
includes:
The UMDNJ-New Jersey Medical School (NJMS) located in Newark is
developing a Clinical Research Center on its campus. Once established,
both Centers will work together to provide the infrastructure to
optimize clinical research across the state. The UMDNJ-New Jersey
Dental School (NJDS) has outstanding research in biomaterials and a
nationally recognized dental training program. The UMDNJ-School of
Health Related Professions (SHRP) has a research team in its nutrition
program that currently collaborates with the CRC at RWJMS. The UMDNJ-
School of Osteopathic Medicine located in Stratford in southern New
Jersey, the UMDNJ-School of Nursing, with statewide nursing programs
and the UMDNJ-School of Public Health provide additional opportunities
for collaboration.
Additionally, UMDNJ is affiliated with the Veterans Administration
Health Care system in New Jersey and already collaborates with the VA
on many initiatives. We would look forward to a partnership with the VA
to provide clinical research studies to this large and diverse patient
population.
UMDNJ is requesting $1.7 million through an NIH grant to develop a
General Clinical Research Center (GCRC) that will link all clinical
research activities across our statewide campuses and allow us to
expand these activities to affiliated partners such as the VA
HealthCare System in New Jersey. The opportunity exists to build a
clinical research organization that would be at the cutting edge of new
medical practices. Collaborations will result in a powerful unit that
can organize medical experts and patients in response to federally and
industrially sponsored trials of new therapies. Federal participation
is needed to support a single network of clinical research and training
programs throughout the state that will provide the impetus for the
designation of our statewide program as a General Clinical Research
Center.
Our final priority is the establishment of a Center for BioDefense:
In considering the threat of biological weapons use, the New York/
New Jersey area is a prime target. UMDNJ is well poised to expand
several current areas of expertise in the national response to this
threat.
UMDNJ's Center for Education and Training (CET) is the nation's
foremost program in education and training concerning chemical threats.
The Center has provided hazardous materials training to more than
175,000 individuals, including police, firefighters and health care
personnel. Preparing emergency response personnel for chemical and
biological incidents is an extension of the Center's existing
expertise.
UMNDJ has several Level I and Level II Trauma Centers within its
statewide system. A crucial component of the trauma network is the
state's helicopter trauma service linking the northern and southern
regions of the State. Members of the UMDNJ Emergency Response Team
participated in a federally-sponsored ``Weapons of Mass Destruction''
education program last year.
A number of laboratories in our system are engaged in rapid methods
of detection of virulent agents with particular emphasis on the most
dangerous multi-drug resistant species. The molecular basis of drug
resistance is the focus of our laboratories, as well as the
establishment of large libraries of clinical strains available for
epidemiological and other studies.
Many of our faculty are advisors to the U.S. Government and serve
on various committees and advisory panels. Our researchers are studying
the effects of exposure to a variety of chemical and organic agents.
UMDNJ has considerable expertise in analysis of genotoxic effects of
radiation, toxic chemicals and other agents.
The University's Newark campus is an internationally renowned
center for the identification, treatment, and basic research of TB and
other emerging and re-emerging pathogens. UMDNJ is a founding partner
in the International Center for Public Health in Science Park, Newark.
The establishment of the Center for Emerging Pathogens at the UMDNJ-New
Jersey Medical School will add another layer of expertise in the
analysis of a number of pathogens.
Gene chip technology is a recent, cutting-edge technology enabling
the simultaneous analysis of thousands of DNA sequences. Recent state
funding has led to the formation of the Center for Applied Genetics at
UMDNJ. In the context of a biological weapons threat, new chips will be
designed displaying sequences representing a panel of potential agents
for rapid screening and identification.
Additional funding of $2.5 milllion will enable UMDNJ to provide a
comprehensive statewide program ranging from our nationally acclaimed
training ability in the public health arena to internationally
recognized expertise in infectious disease basic research.
______
Prepared Statement of New York University
Mr.Chairman: Thank you for allowing me to submit this testimony for
the Promoting healthy lifestyles, eliminating disparities in oral
health on the basis of race and ethnicity, and removing barriers to
health care access are important priorities for the New York University
College of Dentistry. It is therefore a matter of urgency for the
College to undertake major renovations to modernize its patient-care
facilities.
The NYU College of Dentistry has been in existence for 135 years.
NYU educates more than eight percent of the nation's dental graduates,
making it the largest dental school in the United States. It is also
the nation's largest provider of comprehensive preventive, primary, and
specialty oral health care at one site, as well as a major Medicaid
provider and safety net for free or low-cost care to the uninsured and
working poor.
NYU also provides the nation's most extensive private dental health
outreach, preventive education, and screening programs that serve
public schools, day care centers, Head Start programs, handicapped
facilities, hospitals, and homeless shelters. Indeed, last summer over
1,000 New Yorkers took part in a College-sponsored free oral-cancer
screening as part of a national effort to alert Americans about the
dangers of oral cancer.
With the heavy, 24 hour-a-day, 365 days-a-year usage of the NYU
dental clinics and the need to keep pace with changing technologies and
equipment, the NYU College of Dentistry has launched a major capital
project to refurbish and upgrade its clinical facilities to ensure that
patients will be treated in an environment that promotes their optimal
health, safety, and comfort. With 565 clinical operatories (treatment
facilities) serving the public on a daily basis, the College seeks to
upgrade 256 of its most heavily used and antiquated operatories which
are located on four floors of its eleven-story structure.
Recognizing that the clinics are the heart of the institution, NYU
is requesting $5 million over three years to renovate and modernize the
clinics and labs on these four floors currently serving the oral health
needs of a vast number of needy New Yorkers.
who are our patients?
The NYU College of Dentistry has a long tradition of providing
comprehensive, low-cost dental services to people who are unable to
afford private dentistry, including many new immigrants. Each year
NYU's dental clinics treat tens of thousands of poor and low-income New
Yorkers who have no other place to turn for dental care. The NYU
College of Dentistry draws the largest portion of its patient
population from New York City's largely Hispanic Lower East Side, which
is a federally-designated dental health professional shortage area
(HPSA), and has many patients from other medical/dental HPSAs in
Manhattan, including Chinatown, East Harlem, Central/West Harlem, and
Washington Heights/Inwood, as well as shortage areas in Brooklyn.
In all, the NYU dental clinics attract the most multiethnic,
multicultural population in the nation, as evidenced by the fact that:
--65 percent of patients are minority Americans, primarily African
Americans, members of Hispanic subgroups, Asians, Pacific
Islanders, and Native Americans;
--30 percent of patients are senior citizens;
--10 percent of patients are children;
--70,000 of our 250,000 visits annually are made by Medicaid
recipients;
--15,000 people receive emergency care every year;
--5,000 emergency patients are treated free of charge each year, and
since the average cost of a routine visit to the NYU dental
clinics is presently $43.00, compared to $360 to $1,100 for a
typical hospital emergency room visit, this is extremely cost-
efficient care;
--10,000 school children annually visit the NYU pediatric dentistry
clinic; and
--2,500 children receive dental services annually through the Head
Start program, both through a three day-a-week busing program
which brings youngsters to the College and through on-site care
in their neighborhoods, making the NYU College of Dentistry the
largest Head Start provider of dental services in the nation.
In addition to the Head Start busing program, the College buses
children daily from local public schools to the College for care, and
conducts a busing program for elderly adults in cooperation with local
social service agencies. The College has also added, at its own
expense, a state-of-the-art mobile dental van with four dental stations
to expand its outreach effort on behalf of poor children who have been
severely impacted by the dramatic decrease in the availability of
publicly-funded, pediatric oral health resources.
It is anticipated that the mobile dental clinic program will
provide more than 1,500 patient visits each year, consisting of primary
dental care and/or preventive services to preschool and school-age
children ages 4-13 from poor, minority, and immigrant families.
Additionally, staff members inform low-income families of their
eligibility for the dental, prescription, and other health benefits
available to their children through the Children's Health Insurance
Program and Medicaid. Moreover, since the dental van is staffed in part
by minority Americans, including an African-American pediatric dentist,
children who visit the van are exposed to role models for health
profession careers.
institutional recognition
The NYU College of Dentistry's leadership in the health care arena
has been recognized through grants for innovative pediatric dentistry
programs, a Medicaid Managed Care Provider Grant from the New York
State Department of Health to develop a model for school-based dental
services, and significant funding from the National Institute of Dental
and Craniofacial Research (NIDCR) of the National Institutes of Health
(NIH).
The latter includes major support, obtained in collaboration with
the Forsyth Dental Center of Boston, to establish a Minority Oral
Health Research Center at NYU to improve the oral health status of
minorities and increase the number of minorities working in the health
professions. In addition, the College has received widespread acclaim
for initiating the Consortium for the Prevention and Early Detection of
Oral Cancer.
the cost of dental education at new york university
The high cost of dental equipment and materials, combined with the
lack of a hospital infrastructure, has long made the cost of dental
education the highest of any profession. As a private dental school,
the NYU College of Dentistry is often able to pursue newer, more
effective therapeutic approaches and to transfer these advances to
practice with more freedom and speed than is possible among some of our
public counterparts. However, tuition for dental education is
necessarily greater for an independent academic dental institution. For
those of us who make our lives among students, it is therefore never
easy to increase tuition. But although we have redoubled our efforts at
cost containment, we recognize that there is a limit beyond which we
cannot go without sacrificing the quality of our academic and patient
care programs. As a result, NYU's tuition for the 1999-2000 academic
year is $36,886 for each year in the four-year D.D.S. program, making
tuition at the NYU College of Dentistry the highest in the nation.
The irony is that although tuition at NYUCD is very expensive, it
is nevertheless the most cost effective dental education in the nation.
In fact, according to the American Association of Dental Schools, the
amount of money it takes to educate a dental student for one year at
NYU--approximately $40,000--is substantially below the national mean of
$60,000, and less than half of that at some state-supported
institutions.
A chief reason for our high tuition is the prevailing poverty of
the population we treat, which effectively results in NYU dental
students subsidizing the charity care. We provide approximately $4
million in free dental care annually--through tuition.
the infrastructure to care for our community
The NYU College of Dentistry does not currently possess the
infrastructure to support the treatment needs of its patient community,
including the introduction of new technologies. To put it another way,
current clinical facilities impede our ability to provide an optimal
patient care environment for the thousands of patients who seek
treatment daily.
Physically, our clinics are bursting at the seams. Much of the
existing clinical care space is over 35 years old and is cramped and
out-of-date. To meet appropriate standards of care, this infrastructure
must be redesigned immediately. The average size of an operatory is
approximately 65 square feet. In order to provide optimal patient care
involving a dentist and a dental assistant, each operatory should be
100 square feet. Addressing these concerns will require extensive
renovation and modernization of 256 of the existing 565 dental
operatories and development of new space for additional clinical
facilities to keep pace with the growth of our patient pool.
New York University College of Dentistry's health promotion
initiatives, its programs to expand access to mainstream oral health
benefits for our neediest citizens, and its reputation as a force for
social action in medically-underserved areas all place the College in
an excellent position to advance the national agenda for health care.
Accordingly, we believe that support for renovated and modernized
patient care facilities at the College is an appropriate focus for
Congress. The community care goals of the NYU College of Dentistry are
entirely consistent with the commitment to make health care an equal
opportunity, available to all, regardless of financial means, age, or
racial or ethnic group. Our dental clinics also greatly relieve the
pressure on an already over-burdened public health system, and in
emphasizing early, preventive and comprehensive treatment, save health
care costs down the road.
With help in creating clinical facilities that foster the well
being of our community, the NYU College of Dentistry can continue to
meet the needs of new Americans and of native racial and ethnic
minorities, and to alleviate the disproportionate oral health burden of
poor and minority Americans.
Thank you for your consideration.
______
Prepared Statement of the University of Miami School and the Lovelace
Respiratory Research Institute
Mr. Chairman and Members of the Subcommittee: I appreciate the
opportunity to present testimony on behalf of the University of Miami
School of Medicine, the Lovelace Respiratory Research Institute in
Albuquerque, NM and our jointly proposed Tobacco Addiction Risk
Assessment Research Center (TARARC) which will be devoted to the
reduction of health risks associated with addiction to tobacco and
other harmful substances. We deeply appreciate your leadership, Mr.
Chairman. I fully understand and appreciate that you and your
congressional colleagues face many constraints and challenges and we
appreciate your willingness to devote special attention to the
important public health issues related to tobacco addiction and its
many harmful consequences. As the former campaign manager for Tom
Luken, who served on the Hill for over 18 years, I was personally
impressed by the dedication, commitment and hard work that all of you
put into serving this great country of ours. We feel strongly that the
unique challenges you face have never been greater than at this point
in history, but there has also never been a greater opportunity to
apply science-based solutions to solving the riddle of addiction and
greatly improving public health by eliminating or reducing its negative
health consequences.
As you may know, approximately 20 percent of all deaths are
associated with tobacco smoking. Tobacco kills more people than murder,
AIDS, suicide, illicit drug use and automobile accidents combined. The
medical consequences of tobacco addiction include the three leading
causes of death: cardiovascular disease, cancer and cerebrovascular
disease and its related medical costs are astronomical. For example, in
Florida in 1996, tobacco-related Medicaid pay-outs were estimated to be
between $264,000,000 and $365,000,000. However, tobacco use is also the
most preventable cause of disease and death.
We now know that nicotine is at least as addictive as cocaine or
heroin. Recent studies even suggest that nicotine interacts with other
drugs of abuse, that it reinforces craving and increases intake of
cocaine and other drugs. However, nicotine is a special case of
addiction because tobacco is legally sold and its use is not prohibited
among adults. In spite of the evidence that nicotine is an addictive
drug which affects the brain in the same way that illicit substances
such as opiates and cocaine do, nicotine dependence has not been
considered substance abuse.
The University of Miami School of Medicine and the Lovelace
Respiratory research Institute are uniquely qualified to address the
issue of addiction to tobacco and other harmful substances. University
of Miami faculty members have significant expertise and experience in
many relevant areas including substance abuse, evaluation research,
community research, behavioral medicine, disease prevention, treatment
of tobacco-related diseases, basic science research, epidemiology and
public health. The University of Miami's Tobacco Research Evaluation
and Coordinating Center (RECC) has been responsible for the evaluation
of Florida's Tobacco Pilot Program. Other strengths in the area of
biomedical research and treatment include Pediatric Oncology and the
Batchelor Children's Research Center, the Pediatric Environmental
Respiratory Center, as well as the proposed Tobacco Addiction Risk
Assessment Research Center (TARARC). The Batchelor Children's Research
Center is currently under construction and will provide a state-of-the-
art clinical and research facility that will be one of the nation's
largest devoted to children's health. It is designed to foster
collaboration among researchers and clinicians and will include a focus
on cancer as well as many other diseases. It, along with the Pediatric
Environmental Respiratory Center, will provide an appropriate and ideal
setting for the study of tobacco-related, maternal-child health issues
as well as a study of the impact of second-hand (environmental) smoke
on the respiratory health of children. The Lovelace Respiratory
Research Institute has undertaken some of the leading studies of animal
models of smoking and the role of nicotine in immune function.
The proposed Tobacco Addiction Risk Assessment Research Center will
be devoted to the study of unrecognized health risks associated with
addiction to tobacco products, predominantly in minority populations
who may be uniquely susceptible to immune suppression, increased fetal
HIV transmission, increased respiratory inflammation and infection,
synergistic negative health effects with other abused substances and
impaired immunological function of non-smoking family members exposed
at home or in utero. The Center will use animal models to study disease
processes prior to assessing the equivalent condition in human
subjects. Finally, the Center will address the culturally relevant
behaviors that underlie tobacco use in human populations. The
importance of the Center lies in its bridging the use of animal models
to the study of disease in people and the subsequent formulation and
testing of medical and behavioral interventions to improve or eliminate
the negative health consequences associated with tobacco use. Of
further interest is the opportunity to compare two different Hispanic
populations that differ in genetics and cultural characteristics
(Mexican in new Mexican and Cuban in Florida) as well as characterizing
African-American and Caucasian populations. Creating the Tobacco
Addiction Risk Assessment Research Center represents a unique
opportunity to build upon the rich diversity of Florida's population,
the commitment of the University of Miami School of Medicine to the
community and our experience with behavioral interventions,
particularly related to tobacco use and substance abuse. Florida is an
ideal location for the proposed Center, being a bellwether state for
social, demographic and epidemiological changes that the rest of the
nation is currently facing or will face in the near future. Our
extensive experience working with traditionally hard-to-reach
populations such as minority substance abusers will ensure that the
interventions we develop will be culturally and linguistically
appropriate and acceptable. We also have a means for rapid
dissemination of effective prevention and intervention within minority
communities through an already developed community health care
coalition.
The goals of the Tobacco Addiction Risk Assessment Research Center
are to:
--Identify risk behaviors which lead to tobacco use and substance
abuse.
--Reduce the incidence and prevalence of tobacco use and that of
other addictive substances.
--Reduce the development of and suffering from disease associated
with tobacco and other addictive substances through research
and interventions in the basic sciences, clinical medicine and
epidemiological research.
--Reduce exposure to environmental tobacco smoke.
--Develop, test and apply science-based community interventions to
achieve these goals.
We know that intervention with effective prenatal programs saves a
tremendous amount of money that otherwise would be spent on healthcare
after birth. The same can be said for early intervention at other
points in the life cycle. My own personal research experience with the
early detection of breast cancer through the screening of over 30,000
medically underserved women has demonstrated that early detection and
intervention saves dollars as well as lives. As is true for cancer, we
already possess a great deal of knowledge that could be used to develop
interventions and prevention strategies for addiction to tobacco and
other harmful substances. Applying this knowledge could effect savings
of billions of dollars for state, local and national governments.
Equally important, the quality of life will be improved for
individuals, families and their communities as well as society at
large. It is becoming ever more apparent that we, as a society, cannot
afford to ignore prevention and early intervention strategies since
crisis management is far too costly in terms of quality of life and
unnecessary expenditures of dollars.
By achieving our stated goals, the Tobacco Addiction Risk
Assessment Research Center will be in a perfect position to (1) improve
quality of life, (2) decrease morbidity and mortality, (3) increase
survival and (4) significantly decrease health care expenditures by
applying effective prevention and intervention. I thank you very much
for your valuable time and stand ready to serve you in any way
possible.
______
Prepared Statement of the National Association for State Community
Services Programs
The National Association for State Community Services Programs
(NASCSP) thanks this committee for its continued support of the
Community Services Block Grant (CSBG) and seeks an appropriation of
$630 million for the state grant portion of the CSBG. The amount
appropriated for the state grant portion in fiscal year 2000 was $530
million. We are requesting an increase of $100 million in order to
expand the efforts of the Community Services Network in assisting those
families remaining on welfare with the intensive services they need to
transition to work and to assist low-income workers in remaining at
work through supportive services such as transportation and child care.
These additional funds will also assist states in developing services
in the four percent of counties that are not currently served by the
CSBG.
NASCSP is the national association that represents state
administrators of the Community Services Block Grant (CSBG), and state
directors of the Department of Energy's Low-Income Weatherization
Assistance Program.
background
The states believe the Community Services Block Grant (CSBG) is a
unique block grant that has successfully devolved decision making to
the local level. Federally funded with oversight at the state level,
the CSBG has maintained a local network of over 1,000 agencies which
coordinate over $5 billion in federal, state, local and private
resources each year. Operating in more than 96 percent of counties in
the nation and serving over 9 million low-income persons, local
agencies, known as Community Action Agencies (CAAs), provide services
based on the characteristics of poverty in their communities. For one
town this might mean providing job placement and retention services,
for another developing affordable housing. In rural areas it might mean
providing access to health services or developing a rural
transportation system.
Since its inception, the CSBG has shown how partnerships between
states and local agencies benefit citizens in each state. We believe it
should be looked to as a model of how the Federal Government can best
promote self-sufficiency for low-income persons in a flexible,
decentralized, non-bureaucratic and accountable way.
Long before the creation of the Temporary Assistance for Needy
Families (TANF) block grant, the CSBG was setting the standard for
private-public partnerships that could work to the betterment of local
communities and low-income residents. Family oriented, while promoting
economic development and individual self-sufficiency, the CSBG relies
on an existing and experienced community-based service delivery system
of CAAs and other non-profit organizations to produce results for its
clients.
major characteristics of the community services network
Locally Directed.--Tri-partite boards of directors guide CAAs.
These boards consist of one-third elected officials, one-third low-
income persons and one-third representatives from the private sector.
The boards are responsible for establishing policy and approving
business plans of the local agencies. Since these boards represent a
cross-section of the local community, they guarantee that CAAs will be
responsive to the needs of their community.
Adaptability.--CAAs have demonstrated success in moving persons
from welfare to work and in assisting low-income families in achieving
self-sufficiency. CAAs provide a flexible local presence that governors
have mobilized to deal with emerging poverty issues.
Leveraging Capacity.--For every CSBG dollar they receive, CAAs
leverage nearly $3.50 in non-federal resources (state, local, and
private) to coordinate efforts that improve the self-sufficiency of
low-income persons and lead to the development of thriving communities.
Volunteer Mobilization.--CAAs mobilize volunteers in large numbers.
In fiscal year 1997, the most recent year for which data are available,
the CAAs elicited nearly 27 million hours of volunteer efforts, the
equivalent of almost 13,000 full-time employees. Using the minimum
wage, these volunteer hours are valued at more than $139 million.
Emergency Response.--CAAs are utilized by federal and state
emergency personnel as a front line resource to deal with emergency
situations such as floods, hurricanes and economic downturns. They are
also relied on by citizens in their community to deal with individual
family hardships, such as house fires or other emergencies.
Accountable.--The federal Office of Community Services, state CSBG
offices and CAAs have worked closely to develop a results-oriented
management and accountability (ROMA) system. Through this system,
individual agencies determine local priorities within six goals for
CSBG and report on the outcomes that they achieved in their
communities.
The statutory goal of the CSBG is to ameliorate the effects of
poverty while at the same time working within the community to
eliminate the causes of poverty. The primary goal of every CAA is self-
sufficiency for its clients. Helping families become self-sufficient is
a long-term process that requires multiple resources. This is why the
partnership of federal, state, local and private enterprise has been so
vital to the successes of the CAAs.
who does the csbg serve?
National data compiled by NASCSP show that the CSBG serves a broad
segment of low-income persons, particularly those who are not being
reached by other programs and are not being served by welfare programs.
Based on the most recently reported data,
--67 percent have incomes at or below the poverty level; 44 percent
have incomes below 75 percent of the poverty guidelines. In
1997, the poverty level for a family of three was $13,330.
--Only 38 percent of adults have a high school diploma.
--37 percent of all client families are ``working poor'' and have
wages or unemployment benefits as income.
--25 percent depend on pensions and Social Security and are therefore
poor, former workers.
--23 percent receive cash assistance from TANF.
--60 percent of families assisted have children under 18 years of
age.
what do local csbg agencies do?
Since Community Action Agencies operate in rural areas as well as
in urban areas, it is difficult to describe a typical Community Action
Agency. However, one thing that is common to all is the goal of self-
sufficiency for all of their clients. Reaching this goal may mean
providing daycare for a struggling single mother as she completes her
General Educational Development (GED) certificate, moves through a
community college course and finally is on her own supporting her
family without federal assistance. It may mean assisting a recovering
substance abuser as he seeks employment. Many of the Community Action
Agencies' clients are persons who are experiencing a one-time
emergency. Others have lives of chaos brought about by many overlapping
forces--a divorce, sudden death of a wage earner, illness, lack of a
high school education, closing of a local factory or the loss of family
farms.
CAAs provide access to a variety of opportunities for their
clients. Although they are not identical, most will provide some if not
all of the services listed below:
--employment and training programs
--transportation and child care for low-income workers
--individual development accounts
--micro business development help for low-income entrepreneurs
--a variety of crisis and emergency safety net services
--local community and economic development projects
--housing and weatherization services
--Head Start
--nutrition programs
--family development programs
CSBG funds many of these services directly. Even more importantly,
CSBG is the core funding which holds together a local delivery system
able to respond effectively and efficiently, without a lot of red tape,
to the needs of individual low-income households as well as to broader
community needs. Without the CSBG, local agencies would not have the
capacity to work in their communities developing local funding, private
donations and volunteer services and running programs of far greater
size and value than the actual CSBG dollars they receive.
CAAs manage a host of other federal, state and local programs which
makes it possible to provide a one-stop location for persons whose
problems are usually multi-faceted. CAAs manage the Head Start program
in many communities. Using their unique position in the community, CAAs
recruit additional volunteers, bring in local school department
personnel, tap into religious groups for additional help, coordinate
child care and bring needed health care services to Head Start centers.
In many states they also manage the Low Income Home Energy Assistance
Program (LIHEAP), raising additional funds from utilities for this
vital program. CAAs often administer the Weatherization Assistance
Program and are able to mobilize funds for additional work on
residences not directly related to energy savings that may keep a low-
income elderly couple in their home. CAAs also coordinate the
Weatherization Assistance Program with the Community Development Block
Grant program to stretch federal dollars and provide a greater return
for tax dollars invested. They also administer the Women, Infants and
Children (WIC) nutrition program as well as job training programs,
substance abuse programs, transportation programs, domestic violence
and homeless shelters, food pantries, as well as gardening and canning
programs.
examples of csbg at work
CAAs in many states have been working diligently to support
families receiving cash assistance through the Temporary Assistance for
Needy Families (TANF) block grant. The CAAs and the state CSBG offices
have been developing methods of creating an effective transition from
welfare to work for families.
In Illinois, all 36 Community Action Agencies are providing their
outreach workers with training and certification in Family and
Community Development. This is a joint effort of Iowa State University
and Southern Illinois University (SIU) to develop certification
standards. SIU provides three hours of course credits for persons who
successfully complete this program. Illinois now has over 500 people
certified within its 36 CAAs. These individuals will spend more staff
time providing comprehensive assistance to each low-income person to
help them become self-sufficient. At first this expanded effort will
cost more, but will produce lasting results in the long-term.
Additionally all 36 CAAs have entered into performance contracts
with the Illinois Department of Public Aid to assist welfare recipients
who are now ``on the clock'' as far as finding jobs before their
welfare benefits lapse. When an agency places a welfare recipient in a
job whose salary is above 125 percent of the official poverty
guidelines and has benefits, the agency is paid $1,200. They are paid
$1,000 for each successful placement in a job whether or not it has
benefits or has a salary that is equal to 125 percent of the poverty
guideline. The Community and Economic Development Association of Cook
County (CEDA) is using these funds for job creation.
In Pennsylvania, community development has been a major focus. For
example, Montgomery County Development Commission opened the CADCOM
Micro Enterprise Resource Center (CMERC). The purpose of the center is
to nurture start-up and emerging small business. The center provides a
six-week training course, hands-on management assistance, access to
shared office equipment, flexible leases and expandable space. In its
first year, the program successfully started three businesses.
In New Hampshire, CSBG funds are being used for alcohol and drug
rehabilitation programs for welfare recipients to assist them in
staying drug free and in securing and keeping jobs.
To recapitulate: The CSBG provides a community-based service
delivery system. Each local organization, through its local board of
directors, establishes priorities and serves its community and low-
income residents through programs designed and delivered locally in
partnership with state and local governments, businesses, civic and
religious groups and others. The CSBG leverages resources that are far
in excess of the appropriations it receives. Additionally, nearly 27
million hours of volunteer services are contributed to CAAs annually.
CSBG agencies have used the increased funds they received for the last
two years to continue their activities that lead to self-sufficiency
and have become integrally involved in the implementation of TANF in
most states across the nation. Those families who remain on welfare
have substantially greater impediments to successfully becoming self
sufficient, an increase in the CSBG will make it possible to meet these
special needs, while still helping working poor families remain in the
workforce.
NASCSP therefore urges this committee to provide an increase that
factors in inflation and to fund the CSBG grant to the states at $630
million.
______
Prepared Statement of the American Academy of Physician Assistants
On behalf of the nearly 38,000 clinically practicing physician
assistants in the United States, the American Academy of Physician
Assistants is pleased to submit comments on fiscal year 2001
appropriations for Physician Assistant (PA) education programs that are
authorized through Title VII of the Public Health Service Act.
A member of the Coalition for Health Funding (CHF), the American
Academy of Physician Assistants supports the CHF recommendation to
appropriate $37.7 billion for the Public Health Service in fiscal year
2001. The Academy is also a member of the Health Professions and
Nursing Coalition (HPNEC) and supports the HPNEC recommendation to
provide at least $335 million to support the Title VII and VIII
programs in fiscal year 2001. The Academy believes that a 10 percent
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 that the Administration's fiscal year
2001 budget request once again proposes to eliminate funding for the
primary care medicine and dentistry programs, through which physician
assistant educational programs receive support. 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 2001.
overview of physician assistant (pa) education
As many Subcommittee Members are aware, PA programs provide
students with a primary care education that prepares them to practice
medicine with physician supervision. The first PA program was started
at Duke University approximately 30 years ago, and today there are 120
accredited PA educational programs.
Physician assistant programs are located at schools of medicine or
health sciences, universities, teaching hospitals, and the Armed
Services. All PA educational programs are accredited by the Commission
on Accreditation of Allied Health Education Programs upon
recommendation by the Accreditation Review Committee for PA Education.
Prior to admission, the typical PA student has a bachelor's degree
and 45 months of health care experience. The most common prior health
experience of PA students involves pre-hospital care, such as emergency
medical technicians or paramedics. Other students come from backgrounds
in nursing, allied health technologies, mental health fields, and
social work.
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 two-year cycle
and reregister every two years. Also to maintain certification, PAs
must take a recertification exam every six 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 except Mississippi, 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.
A physician assistant provides health care services that were
traditionally only performed by a physician. Duties include, but are
not limited to, performing physical examinations, diagnosing and
treating illnesses, ordering and interpreting laboratory tests,
suturing wounds, assisting in surgery, providing patient education and
counseling, and making rounds in nursing homes and hospitals. Forty-six
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. Fourteen percent of all PAs practice in
rural areas where they may be the only full-time providers of care
(state laws stipulate the conditions for remote supervision by a
physician). Approximately twenty percent of PAs work in urban and inner
city areas. The majority of PAs are in primary care. Nearly one-quarter
practice in surgical specialties. Seventy percent of PAs practice in
outpatient settings.
In 1999 an estimated 154 million patient visits were made to PAs
and approximately 196 million medications were prescribed or
recommended.
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 45 million today. Simultaneously, the
number of medically underserved communities continues to rise, from
1,949 in 1986 to 2,900 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.
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.
Public 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 1991-1999 reveals
that 16.5 percent of students graduating from PA programs supported by
Title VII are from underrepresented minorities, compared to 7.7 percent
of graduates from programs that did not receive Title VII support.
Similarly, 13.5 percent of the graduates who attended PA programs
receiving Title VII support during the eight-year period practice in
underserved communities, compared to 10.1 percent of graduates of
programs not receiving such support during the same period.
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 undersered areas, including new sites in border
communities, and to establish non-clinical rural rotations to help
students understand the challenges faced by rural communities. 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.
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 demand. Additionally, the Bureau of
Labor Statistics projects that the number of available PA jobs will
increase 47 percent between 1996 and 2002.
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.
Between fiscal year 1994 and fiscal year 1997, PA program funding went
from $6.5 million down to $5.9 million and, as of fiscal year 1997, was
restored to $6.376 million. PA program funding was slightly increased
again for fiscal year 1998 at $6.398 million. The fiscal year 1998
appropriation provided 42 awards to support the training of
approximately 1600 PA graduates. The fiscal year 1999 allocation was
$6.8 million; the fiscal year 2000 appropriation for the cluster
assumes funding for the PA programs at the fiscal year 1999 level.
recommendations on fiscal year 2001 funding
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 2001. 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, 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. The Academy is particularly concerned that any increase for
the NIH not be made at the expense of the health professions education
program or other public health programs, as recommended this year by
the Senate Budget Committee.
The American Academy of Physician Assistants is particularly
appreciative of the modest increase in funding for PA education
programs that was appropriated during the 105th Congress. However, the
increase has not been sufficient to meet the increasing demand for PA
graduates in the growing number of medically underserved communities.
Accordingly, the Academy respectfully requests that the Title VII
health professions programs, including PA programs, receive a 10
percent funding increase in fiscal year 2001.
Thank you for the opportunity to present the American Academy of
Physician Assistants' views on fiscal year 2001 appropriations.
______
Prepared Statement of the National Jewish Medical and Research Center
Mr. Chairman and Members of the Subcommittee, thank you for your
support last year and the opportunity to present this testimony
regarding the National Jewish Medical and Research Center's proposal to
build an integrated Center for Environmental Health Research and
Service (CEHRS). This Center will, under one roof, support research and
provide clinical services for patients with respiratory and immune
diseases with the mission of controlling or eradicating environmental
and occupational illness in the Rocky Mountain Region. It will serve as
a regional resource and national model for the delivery of
environmental clinical health services, conduct both basic and field
research on environmental illness, and ``translate'' new knowledge, to
better inform the public and help guide rational environmental policy
by government, at both regional and national levels.
National Jewish Medical and Research Center is known worldwide for
the diagnosis and treatment of patients with environmental,
respiratory, immune and allergic disorders, and for groundbreaking
medical research. For the past 20 years, this century-old nonsectarian,
nonprofit medical center has earned an international reputation for its
treatment of environmental illness and for research leading to the
detection and prevention of environmental disorders including asthma,
berylliosis, tuberculosis, and building-related illnesses.
With funding from Federal agencies including the NIEHS, NHLBI,
NIAID, EPA, DOE, and CDC/NIOSH, as well as foundations and private
industry, National Jewish has become one of the leaders in the field of
environmental health. National Jewish is deeply committed to providing
accessible, affordable and high quality care for environmentally and
occupationally exposed individuals, to consulting for government and
industries in the region and nationally, and to educating medical
professionals and the public on matters of environmental risk and
health.
Our nation faces a significant challenge for the 21st century--how
to safeguard the health of the American public from environmental
hazards. We are faced with the reality that many Americans,
particularly the working poor, blue collar middle class, minorities,
children and the elderly, are exposed daily to environmental toxins
that may cause major lung, heart, immune and allergic diseases,
disability and untimely death. We must find ways to better diagnose,
treat and, most importantly, prevent environmental disease. In
addition, federal agencies and corporations face the daunting task of
cleaning up environmental ``sins of the past''--without unduly
endangering the health of today's hazardous waste workers and the
members of communities that surround them.
The State of Colorado has historically been medically underserved,
in environmental health services, with fewer than 40 medical
practitioners in Colorado who are board certified to practice
environmental and occupational health. While the Division of
Environmental and Occupational Health Sciences at National Jewish
provides consultation to industry, agriculture, community groups, and
labor, its services are outstripped by the regional need for expertise.
National Jewish is forced to turn away many patients and groups who
have environmental concerns because of physical and staffing
limitations at the Center. These needs range from community groups
seeking advice on the hazards of radioactivity and of metal-
contaminated soil, to industries needing help in the control of lead
poisoning and biological hazard exposures, to regional agencies seeking
aid in the investigation of disease outbreaks caused by airborne molds
or tuberculosis-like organisms.
National Jewish is uniquely positioned in the Rocky Mountain region
to serve as a model health care institution for implementing innovative
environmental health programs that reduce the risk of respiratory and
immune system disease. Regionally and nationally, the diseases that are
treated at National Jewish Medical and Research Center are on the rise,
including asthma, diseases due to environmental tobacco smoke,
building-related respiratory and allergic illnesses. National Jewish
Medical and Research Center specializes in helping both small and large
regional employers address practical issues of toxic exposure
assessment, exposure control, medical management of occupational
illness, and remediation. Employees and their employers, while aiming
to make the workplace safer and more productive, often lack enough
information about the toxic effects of airborne chemicals, metals, and
organic matter that produce disability. Recent studies show that 1 in
10-hospital admissions is related to a workplace injury or exposure.
More than half of all patients seen in general medicine clinics in the
central U.S. report past or ongoing exposure to one or more known
toxin.
The solutions to these environmental health dilemmas are to prevent
exposures from causing disease and, if environmental exposures have
already occurred, to detect disease earlier and to develop more
effective treatments for disease.
National Jewish can best increase our effectiveness by housing
these major activities in a single, dedicated location. The CEHRS will
be a showcase for the application of the most advanced environmental
science and directly to the prevention of disease in groups of
Americans at environmental risk. By showing how a multidisciplinary
approach can help eradicate environmental respiratory and allergic
diseases, our Center will be a model for other centers around the
country who may address other forms of environmental illness, such as
those linked to skin disease, neurologic disorders, liver disease, and
cancer. National Jewish Medical and Research Center believes that by
maintaining a tight focus of both clinical care and research in an area
of great need--the respiratory and immune systems--its Center will be
able to deliver long term solutions to the most important forms of
environmental disease.
The CEHRS will meet this need by integrating the following existing
and new program components in the new Center:
The Clinic for Environmental and Occupational Health Care.--A
combined adult and pediatric outpatient clinical practice staffed by
experienced environmental and occupational health physicians and nurses
who diagnose and treat environmental disorders. Annually, this clinical
group screens and evaluates more than 2,000 patients with suspected
environmental or occupational lung and allergic disorders.
The Environmental Disease Prevention and Research Service.--A
multidisciplinary team of physicians, researchers, epidemiologists,
industrial hygienists, and health educators, who conduct practical
research aimed at ``real life'' problems solving by measuring airborne
exposures to toxins and implementing innovative programs that detect
the effects of chemicals in individuals and in the air. The goal is to
devise practical, cost-effective solutions to reducing risks of cancer,
lung fibrosis, and allergic lung disease.
The Environmental Away-Team Consultation Service.--A mobile
consultation service staffed by a team of environmental and
occupational health experts who go anywhere in the country to measure
environmental exposures, monitor for disease, and advise industrial and
agricultural employers, labor, and private citizens on the management
and control of environmental hazards. This service has gone on-site to
more than 20 states.
The Respiratory Protection Program.--A mobile service that helps
individuals and corporations to educate and provide appropriate types
of masks for people being potentially exposed to airborne hazards.
Firefighters, hazardous waste workers, municipal employees, and others
who encounter potentially lethal exposures to highly toxic materials
call on this service.
The Environmental Education/Community Outreach Service.--A risk
communication service that utilizes the internet as well as more
traditional educational approaches to deliver up-to-date, balanced,
practical environmental information to civic groups, labor, industry,
and local and Federal Government agencies.
The Occupational and Environmental Medicine Training Program.--
Based at National Jewish and the Department of Preventive Medicine and
Biometrics at the University of Colorado School of Medicine, this is
the only training program for environmental medicine in the State of
Colorado.
The Environmental Toxicology Section.--A research unit dedicated to
understanding oxidative stress which is a natural process that produces
disease when undesirable oxidant gases or dusts are inhaled, causing
inflammation.
The Environmental Immunology Laboratory.--A research unit dedicated
to understanding how environmental toxins cause allergic diseases.
National Jewish is the only academic research facility in Colorado
that provides clinical care for patients with suspected environmental
or occupational illnesses. Patients from the region as well as from all
50 states come to National Jewish Medical and Research Center for
medical diagnosis and care. Patients receive superior care without
regard to their ability to pay. Each year $7 to $10 million of free or
heavily subsidized care is provided.
National Jewish was recently ranked as the best hospital in the
nation for excellence in treating respiratory diseases in U.S. New and
World Report's ``America's Best Hospitals.'' American Health magazine
termed National Jewish one of the finest U.S. hospitals in allergy,
immunology and pulmonology for both adult and pediatric patients. The
Institute for Science and medicine rated National Jewish among the top
10 independent biomedical research institutions--of any kind--in the
world, and the only one that also provides patient care. It was ranked
as one of the three most influential research institutions for
immunology and as the number one private immunology research
institution in the world.
Partnerships with governmental agencies.--In addition to conducting
research directly funded by several agencies, National Jewish faculty
provide advice and consultation to local, regional and Federal
Government offices, including: the Colorado Department of Health and
the Environment, the Governor's Air Toxics Science Advisory Committee,
the U.S. DOE Beryllium Standards Advisory Committee, oversight Boards
for Hanford Reservation in Washington State, the Nevada Test Site, and
Los Alamos National Laboratories, the EPA air pollution research
advisory panel, and the OSHA Metalworking Fluids Standards Advisory
Committee, and both CDC/NIOSH and NIH research advisory committees.
Partnership with community health organizations.--Faculty members
conduct community outreach, speaking at local hospitals on
environmental health. Three of our faculty have served as presidents of
the Rocky Mountain Academy for Environmental and Occupational Medicine,
the regional society for all physicians practicing in this field.
Partnership with regional industry and labor.--National Jewish has
helped organize and conduct medical education and medical surveillance
programs for many regional industries, helping them to protect
employees from hazards in the workplace.
National Jewish proposes to establish a public/private partnership
with the Federal Government in support of the establishment of the
``Center for Environmental Health Research and Service.'' This
partnership will cover the cost of the construction of a new, 50,000
square foot, state-of-the-art facility which will house all basic and
clinical environmental research, clinical care, outpatient services,
training and consulting services affiliated with the Environmental
Health Research and Sciences program.
The total cost of the proposed facility is $14 million. National
Jewish received a $1 million HRSA grant from this Subcommittee in
fiscal year 1999 and $250,00 last year to carry out the initial phases
for the construction of the CEHRS. National Jewish seeks $5 million in
HRSA follow-on funding in fiscal year 2001 to help construct the new
Center.
Thank you.
______
Prepared Statement of Idaho State University
Mr. Chairman and Members of the Subcommittee, thank you for the
opportunity to submit testimony to the hearing record regarding an
important initiative in rural health being undertaken by Idaho State
University's (ISU) Institute for Rural Health Studies. Specifically,
ISU has requested federal partnership assistance to establish the Idaho
Telehealth Integrated Care Center to address the many health challenges
faced by Idaho as a rural and frontier state where 90 percent of the
geography and about one half of the population is outside of an urban
area. The three main objectives of the Idaho Telehealth Integrated Care
Center (ITICC) are to:
--improve the quality and quantity of access to healthcare for people
living in Idaho's rural and frontier areas,
--promote professional development in telehealth for faculty and
practicing professionals, and
--provide professionals-in-training educational experiences in
integrated care and telehealth.
This integrative model meets many of the objectives for whole-
person primary care outlined in Healthy People 2010. In addition to
improving care and provider professional support, this integrated care
program can serve as a national model for the integration of general
medical, oral health, and mental health.
The goal of this project is to build a comprehensive telehealth
clinic providing consultation and technical assistance in a variety of
fields to support care in rural and frontier areas. The concept is
simple. By contacting the ITICC, facilities in rural and frontier areas
can schedule assistance across the health care spectrum. For example,
if a rural clinic determines they need support in audiology, they can
call the ITICC and schedule an audiology consultation. Rural partners
will be recruited from Tribal Nations, Indian Health Service, critical
access hospitals, private and public clinics. Particular attention will
be taken to provide care in culturally sensitive ways. In addition to
supporting patients and caregivers in rural and frontier areas, the
ITICC will serve as practice and training outlet for the university
community.
Idaho consists of 44 counties covering 83,574 square miles--
geographically, the 14th largest state in the U.S. The 1998 population
of the state was 1,228,684--only 9 states have a smaller population. Of
the 208 towns in the state, 2 have populations over 50,000 and 16 towns
have populations less than 100; 186 have less than 10,000 people. About
40 percent of the population lives outside of an urban area,
distributed over 9/10ths of the states geographical area. Idaho's per
capita income was $18,170, ranking 43rd in the U.S. in 1997. The median
household income was $32,000 in 1997. Idaho ranks in the upper 1/3
(16th) of the states in number of persons employed, but 42nd in average
annual pay. Just over 400,000 people in the state are employed, largely
in the service industry. Forty-one thousand of those people are
employed in health related fields.
In Idaho, an estimated 150,000 people--60,000 of whom are
children--live below the poverty level. Idaho ranks 3rd in the nation
for number of persons under 18 years of age and 40th in persons over 65
leaving the state with an abundance of children and a dearth of older,
potentially wiser, elders. Twenty three percent (23 percent) of
children under 5 live in poverty. In 1995, five counties had no full-
time physician. In 1996, the physician to population ratio was 145 per
100,000 placing Idaho in the unenviable position of having the worst
patient to physician ratio in the United States. Access to mental and
oral health is even more limited.
The Office for the Advancement of Telehealth defines telehealth as
the use of ``telecommunications technologies to support long-distance
clinical health care, patient and professional health-related
education, public health and health administration.'' The distribution
of telehealth is irregular and largely explainable by an area's
resources. According to a 1999 NTIA report on defining the digital
divide, the more available resources, the more likely an area is to
have access to telehealth. While telehealth has been seen as a panacea
for improving health care in rural areas, the very rurality of these
areas is preventing appropriate penetration of the proposed solution.
Integrated telehealth combines two promising trends in healthcare
to lower social and financial healthcare costs. Integrated telehealth
uses telecommunication technology to combine physical and behavioral
healthcare to deliver community-based whole-person care. It overcomes
social, economic, geographical, and climatological barriers that hinder
access. Training students in integrated telehealth care places Idaho as
a leader in healthcare training innovation. Integrated telehealth
should reduce medical error; improve recruitment and retention of
healthcare students and providers; combat burnout and employee
turnover; and improve healthcare in rural and underserved areas.
The key to success for ITICC is building a collaborative network.
While universities and communities have not traditionally enjoyed
strong collaborative relationships, this trend has been reversed in
telehealth. The majority of telehealth programs serving communities
around the U.S. are based in academic centers. Initially, a working
group will be founded composed of consumer, practice, student, and
faculty representatives. Using implementation strategies based on other
successful projects such as the Alaska Federal Health Care Access
Network, East Carolina University, and the Telemedicine Research
Center, the working group will development implementation strategies
for the ITICC. Four telemedicine practice suites and up to eight rural
clinics will be connected with up to an additional 27 rural clinics to
follow bringing the total to 35. The ITICC system will interface with
the Idaho Critical Access Hospital program that will wire up to 50
hospitals. Between the two projects, up to 85 communities will have
access to the ITICC.
The areas of consultation available through Idaho State University
include:
--Geriatric Care
--Family Medicine
--Health Education
--Healthcare Administration
--Mental Health, Child & Adult
--Nutrition Sciences
--Nursing
--Occupational & Physical Therapy
--Oral Health
--Pharmacy
--Radiology
--Rural Health Research
--Speech Pathology & Audiology
This project is designed to avoid the mistakes of other telehealth
programs, which tend to focus on the technology and overlook the
importance of maximizing human capital and the powerful effect of
training on system change. The director of this project has been
involved in designing, implementing, and evaluating telehealth programs
for nearly a decade serving as a technology advisor to national and
international groups and is the author of theory and evaluation papers.
The clinical staff are mature in their fields. The ITICC team has
intentionally chosen a smaller, scaleable project over a larger,
riskier enterprise. Ongoing evaluation, using standardized measures, is
built into the system design. During Year 3 there will be a special
focus on refinement, sustainability, and dissemination of the program
so other programs can benefit from the lessons learned by ITICC.
Sustainability is always a concern for any program, especially one
that is as heavily invested in equipment as telehealth must be. The
core elements of this program are based on proven technology that can
be sustained at minimum cost and frustration to users. Because the
ITICC is connected with a training institution, ITICC money can be
leveraged for other training and research grants. Moreover, because the
ITICC target is health professions shortage area, most consultations
will be reimbursable under HCFA rural telehealth reimbursement
regulations.
Mr. Chairman, ISU is seeking to establish a telehealth model for
rural outreach. The 4 million dollars in federal partnership assistance
requested will provide training benefits as well as improve the quality
of care for Idaho's rural and frontier residents. We believe this will
be an excellent investment of taxpayer funds that will be repaid many
times over through local cost-savings and the provision of an
integrative health model that can be replicated nationally. For
example, it is well documented that local treatment usually results in
cost savings. Receiving appropriate care when it is needed reduces the
risk of hospitalization. It has been calculated that if each clinic
prevents just one hospitalization through appropriate integrative care,
there is the potential for 100 percent cost offset across the life of
this project. Clearly the dollar cost offset is impressive but when
added to the benefits of reduced medical error, better training, and
recruitment and retention of providers in rural and frontier areas the
benefits mount. Perhaps the most compelling case can be made by looking
at the improvement to the quality of life for an individual person and
his or her family and community when appropriate community based,
whole-person care is finally possible.
Thank you.
______
Prepared Statement of Babyland Family Services, Inc.
Mr. Chairman and Members of the Subcommittee, thank you for the
opportunity to submit testimony to the Public Witness Hearing Record
regarding a model educational program that will close the ``digital
divide'' among minority inner city children and families. Babyland
Family Services (BFS) is a major non-profit child and family service
organization, founded in 1968 in Newark, New Jersey, that provides
comprehensive child and family development services at 14 sites to
1,500 at risk children and their families each year. The Annie E. Casey
Foundation, a national leader in children's issues, highlighted
Babyland in its annual 1998 Kids Count report as a model in community-
based child and family development. BFS was also one of a select number
of agencies that received a 1999 Century of Caring award, from the NJ
Division of Youth and Family Services (DYFS), for its service to
children and families. Babyland has also taken the lead on several
community-wide initiatives: Success By 6, Family and Children Early
Education Services (FACES), Abbott Preschool Family Worker Program, and
the Pediatric Asthma Reduction Effort (PARE). These initiatives include
collaborations with over 30 other child care centers, several public
and parochial elementary schools, and several service providers.
Together these initiatives serve over 5,000 children and families.
BFS integrates its wide network of services in order to enable each
child and individual to reach their potential--intellectually,
emotionally, spiritually, socially, and physically. Babyland's holistic
philosophy--integrating child, family, staff and community
development--serves as a model and has been studied by other
communities throughout the nation and as far away as South Africa.
Babyland serves at-risk children (from infancy to 18 years old),
parents striving to be self-sufficient, teenage parents (including
young fathers), struggling families and distressed neighborhoods.
BFS programs provide a continuum of educational services to
individual children as well as multiple support services for family
members. By virtue of this continuum, the agency is able to build
extensive relationships with families and to provide follow-up care. As
a result, BFS is in a unique position to launch and oversee a major
computer and technology initiative that will provide extensive training
and technology support for individual families having no other tangible
means of becoming computer literate or of acquiring the requisite
skills necessary to be informed and self-sufficient. This initiative
would empower not only present clients but also those who will receive
BFS services in the future.
BFS services include:
--Quality child care for children under three years old, through the
Early Head Start Program;
--Early childhood education for preschoolers;
--After school and summer enrichment programs for school-age
children;
--Pediatric health services, including a pediatric AIDS and asthma
program;
--Parent education for teenage mothers and pregnant women, young
fathers, severely distressed parents, foster parents, and
grandparents;
--Emergency shelter and counseling for battered women and children;
--Foster care homes for boarder babies and sibling children;
--Self-sufficiency services that include: life skills, family
literacy, substance abuse and mental health counseling, and
employment training/placement in conjunction with networking
partners;
--Training in the areas of child development, domestic violence,
foster care, family support, health and parent leadership; and
--Community organizing and neighborhood leadership training for
parents and residents.
Computer technology is transforming the economic and social
landscape of this country by offering information and educational
opportunities for individual growth and community development. Inner-
city children and residents are inadequately prepared to take advantage
of these growth opportunities. If the gap in information technology--
the digital divide--is not bridged, a large segment of society will be
further polarized and left without the tools needed for full
participation in society. Specifically, BFS is seeking to establish the
telecommunications linkages necessary for the educational development
of 670 children and to provide computer and technology training for
2,000 parents, teachers, and employees. As a result, this initiative
will strengthen children's educational skills; promote the self-
sufficiency of and enhance the educational skills of parents; enable
the agency to better track child and family needs in order to enhance
client services; and link the community to local and national resource
centers. The proposed technological network will link center and home-
based child care facilities; community resources and service providers;
educational, economic and resource information sources; training
centers and administrative offices. The establishment of this network
will be a model for educating urban children and serve as a conduit for
comprehensive family support services.
The Specific Provisions of the BFS proposal include:
--Computer hardware and software (technical assistance, installation
and wiring, modems, printers etc.) for children, parents and
residents, and teaching/social service staff in classrooms,
homes and social service offices.
--Technology Center, as part of a new multi-purpose community
resource center, that will provide distance learning,
professional development and training in basic and advanced
computer and technology skills for low-income parents,
neighborhood residents and entry-level employees.
--Computer Training, Curriculum Development and Professional
Development for children, parents and residents, educational
and social services staff, as well as national and
international community-based family service providers.
The initiative will benefit:
--Preschoolers (550) at eight centers and 120 school-age children
(after school/summer enrichment programs) at five centers.
--Parents and family members (1,750) at 13 Babyland sites with links
to community resources;
--Agency Staff (250) for client tracking purposes; training and
professional development; and access to community resources to
be provided through workstations and/or palm pilots for
caregivers/teachers and social service staff.
--Parents and children in the home for educational instruction and
support, economic and resource information, links to other
parents and teachers, parenting education (child and family
health, child behavior and development, cultural sensitivity,
etc) and professional education (ex. Certifications, GED,
etc.).
--Family day care homes with links to community resources,
professional education, BFS child care centers and other child
and family resource centers.
--Child and family service providers throughout New Jersey, the
nation and South Africa.
The BFS digital divide initiative will seek specifically to greatly
enhance:
--Early childhood development and education for young children (three
to 13 years old).
--The ability of inner city residents, especially low-income parents
and teenagers, to learn computer and technology skills.
--Tracking of 1,500 children in center- and home-based child care
facilities; teenage parents and victims of domestic violence;
homeless families; foster children and families.
--Provision and delivery of professional development for BFS staff
and parent education programs and curriculum development
efforts.
--Delivery of clinical and therapeutic services to parents and
children.
--The ability to fulfill State and Federal reporting requirements.
--The ability to provide consultation to international family service
providers.
Current BFS parent and staff training programs that will be
continued and expanded through the implementation of this initiative
include:
--Foster parent training for over 300 candidates;
--Domestic Violence training for nearly 40 community staff;
--Family Worker training for over 50 Abbott Preschool family workers;
--Child care training and accreditation for nearly 100 child care
staff from 30 centers;
--Parent leadership training for 30 parents from three public
schools, through a grant from the Victoria Foundation;
--Family literacy training for 40 parents; and
--Family day care training for 20 family day care providers.
Of particular note, Babyland established an international training
program with the Goldfield Metropolitan Corporation, a community-based
organization in South Africa, in order to exchange information on child
care, community development and family services. In 2000, we are
looking forward to providing distance learning for over 100 parents and
staff at the Early Head Start Program.
Mr. Chairman, as your Subcommittee deliberates funding requests
from many qualified candidates coming to you for assistance this year,
I urge you to review and consider our request for a $1 million 21st
Century Learning Centers Grant to bridge the digital divide among
inner-city families in Newark. We make this request in order to help us
fulfill our mandate as a provider for thousands in our city but also,
in return, to act as a model for other agencies in cities around the
country who may also be able to help the technologically disadvantaged
gain access to the resources and skills necessary to survive in the
21st Century.
Thank you.
______
Centers for Disease Control and Prevention
Prepared Statement of the International Brain Injury Association
The International Brain Injury Association (IBIA) respectfully
requests $15 million in fiscal year 2001 for the Traumatic Brain Injury
Act (TBI Act).\1\ IBIA is a non-profit organization dedicated to the
support and development of medical and clinical professionals and
others who work to improve opportunities and successes for persons with
brain injury. Headquartered in Charlottesville, Virginia, IBIA is the
only international association representing and convening brain injury
professionals and specialists throughout the world.
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\1\ Reauthorization of the TBI Act is currently under consideration
by the Congress. Funding must continue uninterrupted through fiscal
year 2001.
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The TBI Act, Public Law 104-166, is the first nationwide attempt to
discern the extent of brain injury in this country, to assist states in
providing services to persons with brain injury, and to further
research on brain injury rehabilitation. Like other medical research
and treatment in the United States, the TBI Act serves as a model for
the rest of the world. IBIA and its members, therefore, strongly urge
your support for $15 million to continue the critical work being done
under the relatively nascent law.
The Act defines TBI as an insult to the brain, not of a
degenerative or congenital nature but caused by an external physical
force, that may produce a diminished or altered state of consciousness,
which results in an impairment of cognitive abilities or physical
functioning. TBI can also result in the disturbance of behavioral or
emotional functioning.
TBI is the leading cause of death and disability in young
Americans. Motor vehicle crashes, sports injuries, falls, and violence
(including shaken baby syndrome and other child abuse) are the major
causes of traumatic brain injury. TBI can strike anyone--infant, youth,
adult or elderly person--without warning, and often with devastating
consequences. TBI affects the whole family and often results in huge
medical and rehabilitation expenses over a lifetime.
Approximately 2 million Americans experience TBI each year. About
half of these cases result in at least short-term disability, and
50,000 people die as a result of their injuries. Each year,
approximately 230,000 persons require hospitalization for TBI (30
percent of which show disabilities a year post injury), and over 1
million people receive emergency medical care for TBI. The national
cost is estimated at more than $48 billion annually. Every year about
80,000 people sustain severe brain injuries leading to long term
disability. Through the TBI Act, the Center for Disease Control and
Prevention (CDC) has estimated that there are 5.3 million persons
living with long term, severe disability as a result of brain injury
and as many as 6.5 million persons living with some form of injury
including mild and moderate brain injuries.
The TBI Act was enacted ``to provide for the conduct of expanded
studies and the establishment of innovative programs with respect to
traumatic brain injury.'' Under the law, the Centers for Disease
Control and Prevention (CDC) is responsible for activities related to
assessing the incidence of traumatic brain injury, conducting
prevention research and increasing awareness of TBI; the Maternal and
Child Health Bureau (MCHB) under the Health Resources and Services
Administration (HRSA), is responsible for implementing a TBI State
Demonstration Program; and the National Institutes for Health (NIH) has
been delegated the responsibility of conducting basic and applied
research and holding a consensus conference.
cdc surveillance, education and prevention
The TBI Act authorized CDC to support studies in collaboration with
State and local health-related agencies to: (1) determine the incidence
and prevalence of traumatic brain injury; and (2) develop a uniform
reporting system under which States report incidents of traumatic brain
injury. CDC has published TBI surveillance methods and guidelines for
public health purposes and created and oversees a multi-state, uniform
reporting system to provide nationally representative data to define
groups at higher risk, causes and circumstances of injury, and outcomes
of injury. This information is critical in the planning,
implementation, and evaluation of programs for preventing TBI and any
accompanying disabilities.
CDC's population based surveillance activities have provided the
data for the epidemiologists and statisticians to estimate the
incidence and prevalence of brain injury in this country. As CDC's
estimates become more refined, the numbers of persons sustaining long
term disabilities as a result of brain injury are increasing
tremendously. Improving the accuracy of these estimates by conducting
surveillance in additional states is crucial to understanding the
impact brain injury has on the nation's medical and rehabilitative
systems and accompanying costs, educational institutions, lost income
and productivity, and the immeasurable toll on persons sustaining brain
injury and their families.
The TBI Act also directed CDC to conduct research into identifying
effective strategies for the prevention of brain injury, implementing
public information and education programs for the prevention of brain
injury, and broadening public awareness of the health consequences of
such injury. CDC has drafted a brochure for persons with mild TBI who
are treated in emergency departments, which discusses potential
problems they may encounter and how to identify services. With
additional funding the brochure can be widely distributed and other
public awareness efforts can be initiated.
For fiscal year 2000, approximately $3 million was appropriated for
CDC's work under the TBI Act. CDC has used most of this funding on its
incidence and prevalence studies. More money is needed for education
and prevention initiatives. We, therefore, respectfully request an
increase of $2 million for education and prevention programs. Funding
of $5 million for fiscal year 2001 is necessary to continue CDC's
surveillance work, as well as to implement effective education and
prevention activities.
hrsa/mchb tbi demonstration grants program
Under the TBI Act, HRSA directs the Maternal and Child Health
Bureaus to provide and administer grants to States for demonstration
projects to improve services for persons with TBI. The TBI
Demonstration Grants are intended to help States implement statewide
systems that ensure access to comprehensive and coordinated TBI
services for the 5.3 million persons with long-term disabilities and
their families. The projects are to involve all relevant disciplines,
organizations and consumers.
State Planning Grants
Planning grantees are developing statewide TBI advisory boards;
designating state agency and staff positions responsible for TBI
activities; assessing statewide needs to address the full spectrum of
care and services from initial acute treatment through community
reintegration for individuals with TBI; and drafting statewide action
plans to develop comprehensive, community-based systems of care that
include physical, psychological, educational, vocational, and social
aspects of TBI services.
State Implementation Grants
The implementation grants require states to establish interagency
linkages; education and training for persons with TBI and their
families; data collection to track programs, resources and enhance
program evaluation; develop materials for low literacy and culturally
or ethnically distinct populations; develop a pre-discharge model to be
used in acute care sites in the development of long term resource plans
for individuals with TBI; and develop a model to coordinate financial
resources to provide services that most effectively meet the needs of
persons with TBI.
In fiscal year 2000, $5 million was appropriated for this program.
To maintain the continuity of these projects, we request $5 million for
fiscal year 2001.
nih research on traumatic brain injury rehabilitation
The TBI Act directed the National Institutes of Health (NIH) to
conduct a consensus conference on TBI. In October 1998, the NIH held
such a conference regarding managing traumatic brain injury and related
rehabilitation concerns. The event was sponsored by the National Center
for Medical Rehabilitation Research (NCMRR) within the National
Institute of Child Health and Human Development (NICHD). Conference
participants evaluated the scientific data concerning rehabilitation
practices for persons with TBI. Particular emphasis was placed on
rehabilitation of cognitive, behavioral, and psychosocial difficulties
associated with mild, moderate and severe TBI. The conference brought
together national and international biomedical researchers and
clinicians, as well as person with TBI and their families.
Participants undertook a detailed review of the evidence-based
scientific evaluations of cognitive and behavioral rehabilitative
interventions. In response to ``what research is needed to guide the
rehabilitation of people with TBI,'' the conference statement listed
the following priorities: \2\
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\2\ The National Institutes of Health Consensus Development
Conference Statement on Rehabilitation of Persons with Traumatic Brain
Injury, October 26-28, 1998.
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--Epidemiological studies on the risk factors and incidence of TBI
are needed for different age groups, gender and race.
--The relationship between substance abuse and TBI should be studied.
--Existing CDC surveillance systems based on hospital discharge
summaries or death records should be expanded to include
emergency department encounters in order to augment the current
database for research.
--Studies of the placement of persons with TBI in nursing homes and
psychiatric facilities are needed to clarify what constitutes
appropriate placement.
--The epidemiology of mild TBI should be studied.
--The duration, natural history, and life-course manifestations
(neurological, cognitive, social, psychological, economic,
etc.) of mild, moderate, and sever TBI should be studied.
--Gender differences in survival rates, patterns of severity, and
long-term manifestations of TBI should be studied.
--The consequences and effects of rehabilitation after TBI in the
elderly should be studied.
--The experience of minority group members with TBI should be
studied.
--Research training is needed in the areas of injury epidemiology and
clinical research in order to enhance the quality of all
research related to TBI.
--The time course of TBI should be studied in animals with respect to
injury severity, influence of age and gender and effects of
interventions.
--Research is needed on the appropriate timing of therapeutic
interventions after TBI.
--Research is needed on the effectiveness of pharmacological
interventions for the cognitive, behavioral, and emotional
consequences of TBI.
--The neurobiology of TBI in humans should be studied with modern
imaging techniques (e.g. positron emission tomography [PET] and
functional magnetic resonance imaging [fMRI]) and correlated
with neuropsychological findings.
--Promising treatments of TBI derived from animal studies should be
tested in humans.
--The epidemiology and management of TBI in sports should be studied.
--Well-designed and controlled studies of the effectiveness of
rehabilitation interventions are needed.
--Economic analysis of TBI including major determinants of costs, is
needed.
--Innovative rehabilitation interventions for TBI should be developed
and studied.
--The predictors of quality of life for persons with TBI, their
families, and significant others should be studied.
--Studies are needed to evaluate the relationship between specific
cognitive deficits and global outcomes.
--Validation of generic health-related quality of life assessment
instruments for use in TBI is needed as well as the development
and validation of TBI-specific instruments.
--Uniform standards and minimal data sets to describe injury type,
severity, and significant interacting variables, which could
provide a total injury profile across a continuum of recovery,
should be developed.
--The relationship between the pathophysiology of TBI and the
effectiveness of different interventions should be studied.
--The long-term consequences of TBI of varying severity, including
the consequences of aging for a person with TBI, should be
studied.
--The developmental impact of TBI in childhood with respect to the
need for special education, mental health, and rehabilitation
services should be studied.
--The effectiveness of community-based rehabilitation of persons with
TBI should be studied.
--Severity risk-adjustment models for studies of persons with TBI
should be established.
--The effectiveness of peer support for persons with TBI, their
families, and significant others should be studied.
--Innovative study methodologies to assess the effectiveness of
complex interventions for persons with TBI should be developed
and evaluated.
The NIH Consensus statement concludes that ``funding for research
on TBI needs to be increased.'' IBIA therefore requests $5 million for
brain injury research to be conducted by the National Institutes of
Health through the National Center on Medical Rehabilitation Research
and/or the National Institute on Neurological Disorder and Stroke.\3\
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\3\ The National Institute on Neurological Disorders and Stroke
engages in numerous research studies, some of which could benefit
traumatic brain injury research; NINDS has expressed an interest in
undertaking TBI specific research.
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conclusion
There are few conditions that can strike anyone at any age at any
time. Traumatic brain injury is one of them, and as a result is often
known as the ``silent epidemic.'' As the United States medical
community perfects trauma care and rehabilitation, more individuals
(who might have otherwise died) are living with brain injuries than
ever before. CDC must keep track of the growth of this epidemic, devise
public awareness campaigns and establish effective prevention programs.
The states need to assess the needs of their communities and include
persons with brain injury in their services. And as the National
Institutes of Health conducts basic and applied research on the myriad
of disorders that affect the brain, trauma to the brain and the
resulting affects on the person and his/her life must not be excluded.
IBIA respectfully requests $15 million in fiscal year 2001 for the
Traumatic Brain Injury Act ($5 million for CDC, $5 million for HRSA,
and $5 million for NIH).
______
Prepared Statement of the Epilepsy Foundation
The Epilepsy Foundation is the national voluntary organization that
works for people affected by seizures through research, education,
advocacy and service. The national office together with its network of
more than 60 affiliates across the country advocate for increased
funding for medical research to find better treatment and an eventual
cure for epilepsy, and works with Federal Government agencies and
Congress to advance the interests of people with epilepsy.
Epilepsy is a neurological condition characterized by recurrent,
unprovoked seizures. It is an economic burden on individuals, families,
communities, and society as a whole because of resultant increased
health care costs. Epilepsy is a formidable barrier to normal life,
affecting educational attainment, employment, and personal fulfillment.
The stigma that comes from seizures and societal misconceptions about
them remain as facts of life for many individuals with epilepsy.
Epilepsy and seizures affect 2.3 million Americans of all ages.
Approximately 181,000 new cases of seizure and epilepsy occur each
year; 10 percent of all Americans will experience seizures in their
lifetimes. According to the most recent data available, in 1995,
300,000 children aged 14 and under had epilepsy; 1.4 million adults
under age 64 and 550,000 aged 65 and over had epilepsy. Epilepsy is a
chronic condition that usually requires a lifetime of continual medical
treatment and education. As many as 44 percent of people with epilepsy
continue to have seizures despite treatment; 56 percent have early or
delayed seizure control with treatment. Currently, there is no cure for
epilepsy.
the cost of epilepsy in the united states
Epilepsy is a major, unsolved health problem affecting the lives of
millions of Americans and their families. The economic impact in the
United States is also tremendous. A three-year study sponsored by the
Epilepsy Foundation to determine the financial costs of epilepsy to
individuals and the nation was completed in 1999. Using data from
actual cases as a basis for the estimate, the annual financial cost of
epilepsy in the United States is approximately $12.5 billion. Of this,
$1.7 billion (14 percent) are direct medical costs while $10.8 billion
(86 percent) are indirect medical costs. The study also found marked
divisions in costs among those people with epilepsy whose seizures are
easy to control and those who continue to experience seizures, despite
treatment.
Indirect costs are primarily employment related. Individual men and
women who continue to experience seizures despite treatment were
estimated to lose hundreds of thousands of dollars in wages while also
experiencing loss of productivity at home. Each man lost a total of
$317,000 or 35 percent of his lifetime wages. Each woman lost a total
of $140,000 or 25 percent of her lifetime wages.
The high concentration of costs among those people with epilepsy
who continue to experience seizures emphasizes the importance of
seizure control in reducing the economic burden of epilepsy on society
and the individual and also demonstrates the cost-saving potential of
effective interventions that increase seizure control. Recent advances
in medical, surgical, and vagal nerve stimulation therapies hold
promise for reducing the frequency and severity of seizures in people
with intractable epilepsy.
Epilepsy research is an area largely under-funded compared to other
diseases. The results of this cost study provide compelling evidence of
the need for increased support in this area. The cure of intractable
seizures and all forms of epilepsy must be a research priority for the
nation.
curing epilepsy: focus on the future
A White House-initiated conference sponsored by the National
Institute of Neurological Disorders and Stroke was held March 30-31,
2000 at the National Institutes of Health. The conference featured
clinicians and scientists who discussed innovative discoveries likely
to lead to the prevention and cure of epilepsy. Presentations on
diverse topics included the prevention of epileptogenesis (how epilepsy
begins), ameliorating the effects of epilepsy genes, monitoring
epileptogenesis, developing new therapies and using surgery and other
forms of technology.
The primary message from the conference is that epilepsy treatment
is due to undergo a fundamental change in direction from treating the
seizures which are the symptoms of epilepsy to treatment of the
underlying condition in the brain. The goals of treatment will be the
prevention and cure of epilepsy, no seizures and no side effects for
those who have already developed the condition and dramatic new ways of
preventing epilepsy that is acquired from injury, infection or errors
of development.
Opportunities for further breakthroughs in epilepsy research
identified at the conference are dependent upon increased funding to
the National Institutes of Health and the National Institute of
Neurological Disorders and Stroke and the development of a coordinated
plan for pursuing these opportunities.
advances in epilepsy research
In his testimony before the House Appropriations Subcommittee on
Labor, Health and Human Services, Education and Related Agencies,
Gerald D. Fischbach, M.D., Director, NINDS, described several major
initiatives for fiscal 2001. These priorities include efforts to
address developmental and degenerative disorders of children, such as
epilepsy, that can result in a lifetime of disability. The severe
epilepsy syndromes of childhood produce developmental delay and brain
damage that can result in a life of dependence on others and
continually accruing costs to the health care system and society.
Research has led to the discovery of good predictors for remission or
relapse of epilepsy in children. For the sake of these children and
those others who will develop epilepsy, research focused on the
prevention and treatment of epilepsy in our youngest citizens must be a
national priority.
One area of research that holds great promise is the identification
of the genes responsible for predisposition to certain types of
epilepsy. Research has identified several genes for childhood
epilepsies in the last few years. During his recent testimony, Dr.
Fischbach explained that the NINDS has emphasized gene discovery in
epilepsy since even the most common forms, such as febrile convulsions,
have a heritable component. Advances in genetic therapy, coupled with
genetics research, will not only suppress seizures, but cure certain
types of epilepsy.
Another area of great clinical importance to people with epilepsy
has been the development of new anti-epileptic drugs. The Foundation
recommends research support from the NINDS for comparative trials of
anti-epileptic drugs to assure that people with epilepsy receive the
greatest possible benefit from these newly available medications. These
medications have shown great promise but more research is needed to
eradicate this disorder.
centers for disease control epilepsy program
As directed by Congress in 1993, the CDC launched its epilepsy
program within the National Center for Chronic Disease Prevention and
Health Promotion. Focusing on early detection and effective treatment
of epilepsy, the epilepsy program targets its outreach and education
efforts on consumers, health professionals, and health systems. The CDC
was appropriated an additional $1 million for fiscal year 2000 to
expand epilepsy surveillance, public awareness activities, and public
and provider education. The fiscal year 2000 funding is the first
significant increase since 1993, illustrating Congress' and CDC's
renewed commitment to epilepsy and the issues which surround it.
Current CDC activities in the area of epilepsy include programs
geared toward teens and adolescents, a population which struggles with
the stigma associated with this disorder. The Foundation hopes to help
teens, through a web based teen chat room, forums, and special events,
to make more informed decisions about their behaviors and life plans,
while at the same time educating the general public.
Experts agree that timely recognition of seizures and effective
treatment can reduce the risk of subsequent brain damage, as well as
disability and mortality from injuries incurred during a seizure and
from recurring seizures. With additional funding in fiscal year 2001,
epilepsy activities can be expanded to include a broader public
awareness and communication strategy including laying the groundwork
for programs targeted at seniors and children and continued efforts for
teens. Increased funding would allow for the implementation of local
community activities; improved surveillance and prevention research;
and more extensive provider education.
fiscal 2001 funding recommendations
Epilepsy research funded by the National Institute of Neurological
Disorders and Stroke is vital to continuing the fight against epilepsy.
The promise of future breakthroughs in epilepsy research can only be
achieved by increased funding for epilepsy research and prevention
programs. The Foundation urges Congress to increase the federal
commitment to epilepsy research by allocating sufficient funding for
the NINDS and Centers for Disease Control.
National Institutes of Health.--The Foundation supports
Congressional efforts to double the NIH budget over 5 years and is
seeking a 15 percent increase for fiscal 2001, resulting in a total NIH
budget of $20.6 billion.
National Institute of Neurological Disorders and Stroke.--The
Foundation supports a 15 percent increase for NINDS in fiscal 2001,
creating a total NINDS budget of $1.19 billion. This increase is
consistent with efforts to double NIH research funding over 5 years.
Epilepsy Research.--The Foundation urges Congress to support a
major expansion of epilepsy research within NINDS. In 1999, NINDS spent
approximately $74 million dollars on epilepsy research. We are seeking
a commitment to triple that amount over the next few years.
Centers for Disease Control Epilepsy Program.--The Foundation is
seeking a $5 million increase in fiscal year 2001 support for the CDC's
epilepsy program within its chronic and environmental account. With
additional resources, the CDC and the Foundation can make great strides
in combating the negative consequences associated with epilepsy and
seizures.
______
Prepared Statement of Rotary International
Chairman Specter, Senator Harkin, members of the Subcommittee,
thank you for this opportunity to present written testimony on behalf
of Rotary International in support of the polio eradication activities
of the U.S. Centers for Disease Control and Prevention. As you know,
2000 is a water shed year in the battle to eradicate polio. The
penultimate goal of the international polio eradication initiative, the
interruption of polio transmission, is within our grasp. We remain on
track for our primary target: certification of eradication by 2005.
This monumental effort, toward which countless millions have
endeavored, has required the commitment and fortitude of a climb to
Everest's peak. As we near our goal--a world free of polio--we cannot
become complacent. We cannot allow the daunting challenges that lie
before us to diminish our resolve. As with an expedition to scale
Everest, the most difficult stage of our journey, the stage most
fraught with the risk of failure, is the final push to the summit.
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 the CDC's
polio eradication activities, the battle against polio would be
impossible.
The global eradication strategy is working. In 1985, when Rotary
began its PolioPlus Program, 100 nations around the world suffered
under the burden of polio. The Western Hemisphere has now been polio-
free for nearly 9 years, and today polio is confined only to Sub-
Saharan Africa, parts of the Middle East, and South Asia.
Thanks to the polio eradication efforts over the last decade,
approximately three million children who might have been polio victims
are walking and playing normally. Tens of thousands of public health
workers have been trained to investigate cases of acute flaccid
paralysis and manage immunization programs. Cold chain, transport and
communications systems for immunization have been strengthened. A
network of more than 140 polio laboratories has been established.
Significant challenges lie before us. Continued political
commitment is essential both in polio endemic countries, to support the
acceleration of eradication activities, and in donor countries, so that
the necessary human and financial resources are made available. Access
to children everywhere is needed, particularly in countries affected by
conflict. Truces must be negotiated if National Immunization Days are
to proceed in these countries. The continued leadership of the United
States is critical if we are to overcome these challenges.
Rotary International is a global association of more than 29,000
Rotary clubs, with a membership of over 1.2 million business and
professional leaders in 160 countries. In the United States today there
are some 7,500 Rotary clubs with 400,000 members. All of our clubs work
to promote humanitarian service, high ethical standards in all
vocations, and international understanding.
Less than one year remains to defeat this disease in the nations
where the poliovirus still causes death and disability. With your
continued support, soon no child will ever be struck down by polio
again.
fiscal year 2001 budget request
For fiscal year 2001, we respectfully request that you provide $91
million for the targeted polio eradication efforts of the Centers for
Disease Control and Prevention, a $5 million increase from the fiscal
year 2000 funding level, thereby meeting the President's budget
request. This $5 million increase is necessary to meet the meet the
need for additional oral polio vaccine resulting from the accelerated
immunization schedule in 2000. In addition, we must continue to meet
the enormous costs of eradicating polio in its final stronghold--sub-
Saharan Africa. The underdeveloped and conflict-torn countries of
Africa represent the greatest challenges to the success of the global
Polio Eradication Initiative. This additional appropriation will allow
the CDC to help African nations accelerate polio eradication
activities, improve surveillance for polio and other diseases, and
support peace-building cease-fires for NIDs. Without the additional $5
million, we may not be able to eradicate polio in Africa by the Target
2000 date, prolonging the need to continue expensive NIDs and routine
immunization worldwide. The time for the final assault against polio is
now.
eradicating polio will save the united states at least $230 million
annually
In 1998 the Chairman of the House Committee on International
Relations commissioned the General Accounting Office to investigate the
soundness of WHO cost estimates for the eradication or elimination of
seven infectious diseases. The United States was a major force behind
the successful eradication of the smallpox virus, and the GAO concluded
that the eradication of smallpox has saved the United States some $17
billion to date. Even greater benefits will result from the eradication
of polio.
Although polio-free since 1979, the United States currently spends
at least $230 million annually to protect its newborns against the
threat of importation of the poliovirus, in addition to its investment
in international polio eradication. Globally, over $1.5 billion U.S.
dollars are spent annually to immunize children against polio. This
figure does not even include the cost of treatment and rehabilitation
of polio victims, nor the immeasurable toll in human suffering which
polio exacts from its victims and their families. Once polio is
eradicated and immunization against it can be discontinued, tremendous
resources will be unfettered to focus on other health priorities.
progress in the global program to eradicate polio
Thanks to your leadership in appropriating funds, the international
effort to eradicate polio has made tremendous progress.
--Since the global initiative began in 1988, 3 million children in
the developing world, who otherwise would have become paralyzed
with polio, are walking because they have been immunized.
--The number of polio cases has fallen from an estimated 350,000 in
1988--of which 35,000 were reported--to approximately 6,000
reported cases in 1999. More than 180 countries are polio-free,
including 4 of the 5 most populous countries in the world
(China, U.S., Indonesia and Brazil).
--Almost 2 billion children worldwide have been immunized during NIDs
in the last 5 years, including 147 million in a single day in
India. During 74 National Immunization Days, 16 Sub-National
Immunization Days and 7 Mopping-up activities conducted in
1999, over 450 million children received oral polio vaccine.
This represents nearly 75 percent of all the world's children
under the age of five.
--All polio-endemic countries in the world have conducted NIDs--most
recently in Sierra Leone and Democratic Republic of the Congo.
The achievement of successful NIDs and implementation of APF
surveillance in Somalia and Sudan shows that polio eradication
strategies can be implemented in all countries.
the role of the u.s. centers for disease control and prevention
Rotary commends the CDC for its leadership in the global polio
eradication effort, and greatly appreciates your Subcommittee's support
of the CDC's polio eradication activities. For 2000, you appropriated a
total of $87.2 million for the CDC's global polio eradication
activities. Because of Congress' unprecedented support, in 2000 the CDC
is:
--Supporting the international assignment of more than 110 long-term
epidemiologists, virologists, and technical officers to assist
the World Health Organization and polio-endemic countries to
implement polio eradication strategies, and 10 technical staff
to assist UNICEF and polio-endemic countries. This includes 30
CDC staff provided directly on assignment to WHO and UNICEF.
--Providing over $60 million to UNICEF for approximately 700 million
doses of polio vaccine and operational costs for NIDs in some
60 countries in Asia, Eastern Europe, the Middle East and
Africa. Many of these NIDs would not take place without the
assurance of the CDC's support.
--Providing over $20 million to WHO for surveillance and NIDs'
operational costs, primarily in Africa. As successful NIDs take
place, surveillance has emerged as a critical need, to
determine where polio cases are continuing to occur. Good
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.
--The leading specialized polio reference lab in the world providing
the largest volume of both operational (poliovirus isolation)
and technologically sophisticated (genetic sequencing of polio
viruses) lab support to the 148 laboratories of the global
polio laboratory network.
--Serving as the primary technical support agency to WHO on
scientific and programmatic issues regarding: (1) laboratory
containment of wild poliovirus stocks following polio
eradication, and (2) when and how to stop 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, much of Latin America is free of measles, due in
part to improvements in the public health infrastructure implemented
during the war on polio. As a result of this success, measles has been
targeted for eradication in the Americas by the year 2000. The disease
surveillance system--the network of laboratories and trained personnel
built up during the Polio Eradication Initiative--is now being used to
track measles, Chagas, neonatal tetanus, and other deadly infectious
diseases. NIDs have been used as an opportunity to give children
essential vitamin A, as well as polio vaccine. The campaign to
eliminate polio from communities has led to 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. Lastly, the unprecedented cooperation between the
public and private sectors serves as a model for other public health
initiatives.
resources needed to finish the job of polio eradication
The World Health Organization estimates that $1 billion is needed
from donors for the period 2000-2005 to help polio-endemic countries
carry out the polio eradication strategy. The estimated shortfall for
the years 2000-2001 now stands at approximately $300 million. In the
Americas, some 80 percent of the cost of polio eradication efforts were
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 are
asking that the United States continue to take the leadership role in
meeting this shortfall.
The United States' commitment to polio eradication has stimulated
other countries to increase their support. Belgium, Canada, Germany,
and Italy are among those countries that have followed America's lead
and have recently announced special grants for the global Polio
Eradication Initiative. Japan has also expanded its support to polio
eradication efforts in Africa. Germany has made major grants that will
help India eradicate polio by the target year 2000. In December 1999
the United Kingdom announced two grants totaling U.S. $94.6 million for
polio eradication efforts in India and Africa. The Government of India
will receive U.S. $62.6 toward its Pulse Polio Initiative over the next
two years. In addition, the U.K. will grant a total of U.S. $32 million
to African nations that are poliovirus reservoirs, affected by conflict
or both. These nations include Nigeria, Ethiopia, Somalia, Sudan, DR
Congo and Angola.
By the time polio has been eradicated, Rotary International expects
to have expended approximately $500 million on the effort--the largest
private contribution to a public health initiative ever. Of this, $373
million has already been allocated for polio vaccine, operational
costs, laboratory surveillance, cold chain, training and social
mobilization in 120 countries. More importantly, we have mobilized tens
of thousands of Rotarians to work together with their national
ministries of health, UNICEF and WHO, and with health providers at the
grassroots level in thousands of communities.
Polio eradication is the most cost-effective public health
investment, as its benefits accrue forever. The world will begin to
``break even'' on its investment in polio eradication only two years
after the virus has been vanquished.
When we reach the summit, we will be able look out upon a world in
which the scourge of polio is a thing of the past. This will be our
gift to the children of the twenty-first century.
Thank you for this opportunity to present written testimony.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM) is pleased to provide a
written statement on the fiscal year 2001 appropriation for the Centers
for Disease Control and Prevention (CDC). The ASM is the largest single
life science society in the world with more than 42,000 members
representing a broad spectrum of subspecialties, including
microbiologists who work in clinical, public health, biomedical and
industrial laboratories. The ASM appreciates the Subcommittee's ongoing
support of the CDC, particularly for the CDC's National Center for
Infectious Diseases (NCID), which funds programs, addressed in this
statement, related to emerging and drug resistant infectious diseases,
public health infrastructure, bioterrorism preparedness and food
safety.
The ASM endorses the recommendation of the CDC Coalition to
increase the overall CDC budget to a level of $4.1 billion, an amount
that exceeds the President's budget request by approximately $600
million. The CDC requires additional new resources to respond to an
array of continuing and new public health challenges. As the ``Nation's
Prevention Agency,'' the CDC is charged with promoting health and
quality of life by anticipating, identifying, preventing and
controlling diseases and other public health threats. The CDC must have
adequate resources to expect and be prepared for unexpected public
health emergencies throughout the country and across the globe,
including, for example, a bioterrorism event, a global influenza
pandemic, a large scale environmental disease threat or an unforeseen
public health danger.
In the following statement, the ASM will focus on specific areas
within the CDC budget which are of concern to the microbiological
community.
emerging and drug resistant infectious diseases: public health threats
and needs
The American people benefit from a well-funded and effective
federal health system. In the past year, the rapid response by health
officials identified an outbreak of West Nile encephalitis in New York,
Connecticut and New Jersey; linked E. coli O157:H7 infection at an
upstate New York county fair to contaminated water; and tied a multi-
state outbreak of Listeria infections to contaminated hotdogs and cold-
cut meats manufactured at a single plant. These successes are due to
state-of-the-art molecular laboratory diagnostic tools, as well as to
coordinated communications and disease reporting systems among health
agencies. Initiated in 1995 by the CDC, the Epidemiology and Laboratory
Capacity for Infectious Diseases cooperative agreements are helping to
rebuild the nation's public health infrastructure at state and local
levels, and making possible success against infectious disease
outbreaks. In fiscal year 1999 CDC awarded more than $40 million to all
states and four cities to boost preparedness against possible chemical
and biological terrorism, and developed laboratory protocols for
several of the possible bioterrorism agents to share with state and
local laboratories. In 1999 the CDC also distributed nearly 300,000
copies of recommendations for prevention and control of hepatitis C
infection (HCV) infection and HCV-related liver disease to physicians
and health care providers nationwide.
The ASM recognizes and applauds the breadth of the CDC's
contributions to these and other successful public health campaigns.
Despite positive past experiences, however, the vigilance needed
against disease will only intensify as we move through the 21st
century. The blood-borne hepatitis C virus, for example, has infected
more than 4 million persons in the United States, 3 million of whom
remain chronically infected and therefore at risk for developing
cirrhosis or liver cancer. In this country each year, 8000 to 10000 die
from cirrhosis or primary liver cancer. The CDC is coordinating the
Hepatitis C Public Information Campaign, aimed toward notifying all
prior transfusion recipients at risk for HIV infection. It will
continue ongoing investigations into various risk factors and modes of
transmission, as well as collaborate with other groups like the
American Liver Foundation to educate the public about HCV. Sufficient
funding would strengthen and expand this multipronged effort against
HCV infection. Like the hepatitis viruses, both ``old'' and newly
emerging or reemerging infectious diseases will continue to challenge
our society's well-being and productivity, and thus make even more
imperative an adequately funded federal public health agency.
The CDC is recognized the world over for its efforts to combat the
threats of new, emerging and drug resistant infectious diseases.
Infectious diseases are a crisis of global proportions which threaten
gains in health and life expectancy and which are now the world's
biggest killer of children and young adults. Substantial new funding is
needed to enable CDC to fully implement its comprehensive plan,
``Preventing Infectious Diseases: A Strategy for the 21st Century.''
The additional $25 million requested for this initiative in the
Administration's fiscal year 2001 budget would not provide adequate
resources needed to fully implement the next phase of the plan. The ASM
concurs with other supporters of the CDC that an additional $162
million would achieve in the appropriate time frame the CDC goals set
forth in 1998 for emerging infections. These goals include a broad
range of improvements to such critical functions as detection and
prevention of emerging pathogens, communication among all levels of
government health agencies, and integration of laboratory science with
on-site epidemiology.
Also targeted in the 1998 plan was the alarming trend toward
antimicrobial resistance among pathogenic microorganisms. Approximately
28 percent of bacteria that cause hospital-acquired infections in the
United States, for example, are resistant to the specific antibiotic
once considered most effective against that particular infection.
Especially problematic is the reduced susceptibility of Staphylococcus
aureus to vancomycin. The CDC has specific plans to address this
problem which will require sufficient funding: improved clinical
guidelines for antibiotic usage; better public education on the issue
of overuse of antibiotics; research on antibiotic resistance genetic
markers as monitoring devices; and a national surveillance system to
assess the overall impact of antibiotic resistance.
public health infrastructure
The ASM recommends that Congress increase the budget requested to
modernize the CDC's outmoded, severely inadequate and deteriorating
physical plant. CDC needs funding and authority to modernize existing
laboratory and support facilities and construct new facilities
according to its long range facilities master plan which addresses
building and facilities needs through the year 2009. Almost all of
CDC's laboratory capacity is currently dangerously antiquated, unsafe
and unsuitable for modern scientific research activities related to
CDC's public health role. CDC has experienced substantial program
growth in recent years, and facilities have not kept pace with new
programs created in response to an increasing number of dangerous
threats from deadly pathogens. The ASM recommends that Congress provide
at least the $127 million requested (an additional $70 million over
fiscal year 2000) for CDC infrastructure needs and consider providing
an even higher level of $175 million to fully meet the facilities needs
and repairs at CDC and accelerate planned construction and upgrades.
bioterrorism preparedness and response
The CDC has established a national effort to protect the public's
health in the event of a biological or chemical terrorist attack. The
initiative builds on the efforts begun at CDC in fiscal year 1999 that
focused on building core capacity within CDC and in states to establish
clinical laboratory surveillance, information technology and
epidemiologic expertise for the highest probability agents. The ASM
notes that funding for CDC bioterrorism preparedness activities
decreases by $6.5 million to a level of $148.5 million in the
Administration's budget request. Current funding levels permit only
partial implementation of this program, leaving many states and cities
with limited or no coverage in some key preparedness areas. Additional
funding would allow more state and local health departments to build
capacity in essential areas of biological and chemical preparedness
including: planing, surveillance and epidemiology, biological and
chemical laboratory services and electronic communication.
A recent Institute of Medicine report on ``Chemical and Biological
Terrorism: Research and Development to Improve Civilian Medical
Response,'' stresses the need for long-term public health
infrastructure improvements. Bioterrorism preparedness is also a part
of CDC's larger effort to reinvest in the public health system to
establish capability to respond to naturally occurring infectious
disease threats. The ASM supports the requested $2 million for CDC
deterrence efforts to monitor laboratory compliance with the
Antiterrorism and Effective Death Penalty Act of 1996 and to ensure the
safe handling of potential threat agents in diagnostic and research
laboratories.
foodborne and waterborne diseases
While often not as dramatic as a newly identified infection,
foodborne and waterborne disease outbreaks in recent years have been
sudden and deadly. The CDC rightly has not neglected this ever-present
threat to the American public. In collaboration with the FDA and USDA,
the CDC has revitalized measures against further outbreaks caused by
contaminated food and water supplies. For example, the CDC PulseNet
program, now in more than 30 states, enables local health departments
to rapidly identify the microbial agents responsible for an outbreak,
by utilizing modern molecular fingerprinting technologies. Rapid
response is essential in such outbreaks, as spread of infection can
occur if the food or water source is not quickly identified and
removed. Foodborne diseases alone are estimated to cause 5,000 deaths
and 76 million illnesses in the United States yearly. Therefore, the
ASM recommends approval of the Administration's proposed increase of
$10 million for foodborne diseases as part of the CDC budget for
infectious diseases in fiscal year 2001.
cost effective strategy
An investment today in the CDC is an investment in tomorrow's
public health. Finding our way safely through the maze of public health
problems often seems costly, but the collective price tag of infectious
disease in death, illness, and dollars is alarming. For instance,
hospital-acquired infections kill 88,000 people annually in United
States and cost more than $4.5 billion each year. Public health
officials estimate that foodborne illness costs this nation's economy
several billion dollars annually. Just in this country, the influenza
pandemics of 1957-1958 and 1968-1969 created combined economic losses
of about $32 billion (1995 dollars).
Monetary savings, of course, are not the only reward from a strong,
innovative, and forward-looking public health system in the United
States. More importantly, the American public rightly receives physical
and emotional benefits from its long-standing support of medical and
scientific research. Those benefits may be direct and obvious, such as
identification of contaminated water supplies, or less obvious but
equally important, as in the case of a strengthened infrastructure for
public health to develop and share health-related technologies and
information among health agencies. A reinvigorated public health system
with effective programs will help protect the public against existing
and emerging threats, such as antimicrobial resistance, chronic
diseases with infectious origins and pandemic influenza.
Thank you for the opportunity to provide a written statement for
the hearing record on the CDC's fiscal year 2001 appropriations.
______
Prepared Statement of The American Heart Association
Chances are heart attack or stroke will be the death or disabler of
you or a loved one. Heart attack, stroke and other cardiovascular
diseases remain America's leading cause of death and a main cause of
disability. Cardiovascular diseases account for nearly 1 of every 2
deaths in the U.S.
The American Heart Association is dedicated to reducing death and
disability from heart attack, stroke and other cardiovascular diseases.
We commend this Committee for making fiscal year 2000 funding for the
National Institutes of Health and the Centers for Disease Control and
Prevention a top priority. But, we are concerned that our government is
still not devoting sufficient resources for research and prevention of
America's No. 1 killer--heart disease--and to our country's No. 3
killer and a leading disabler--stroke.
Heart attack, stroke and other cardiovascular diseases have been
America's No. 1 killer since 1919. Nearly 60 million Americans--1 in
5--of all ages suffer from one or more of these diseases. Hundreds of
millions of Americans have major risk factors for these diseases--about
50 million have high blood pressure, 40 million have elevated blood
cholesterol (240 mg/dL), 49 million smoke, 106 million adults are obese
or overweight and 10 million have physician-diagnosed diabetes. As the
baby boomers age, the number of Americans afflicted by these often
disabling diseases will increase substantially. Cardiovascular diseases
cost Americans more than any other disease. Americans will pay an
estimated $327 billion for cardiovascular-related medical costs and
lost productivity in 2000. These diseases constitute 4 of the top 5
hospital costs for all payers, excluding childbirth and its
complications, and 4 of the top 5 Medicare hospital costs. Heart
disease is also the leading cause of premature, permanent disability of
American workers, accounting for nearly 20 percent of Social Security
disability payments.
how you can make a difference
Now is the time to capitalize on a century of progress in
understanding heart attack, stroke and other cardiovascular diseases.
Promising, cost effective breakthroughs in treatment and prevention are
on the horizon. We challenge our government to stay the course to
double funding by year 2003 for NIH, for heart and stroke research and
to translate research into effective clinical and community
initiatives. This will cut health care costs and improve quality of
life. For fiscal year 2001 we urge you to do the following.
--Appropriate a 15 percent increase over fiscal year 2000 funding for
the overall NIH--the third step toward the goal of doubling the
budget by year 2003. This goal is echoed by groups such as
Research!America and the Ad Hoc Group for Medical Research
Funding.
NIH research provides cutting-edge treatment and prevention
strategies, cuts health care costs, creates jobs and maintains
America's status as the world leader in biotechnology and
pharmaceuticals industries.
--Provide a 15 percent increase over fiscal year 2000 funding for NIH
heart research and stroke research.
Researchers are on the brink of advances that could pave the way to
prevention and even a cure so you or a loved one will be spared pain
and suffering from heart disease and stroke.
--Allot a $25.2 million increase over fiscal year 2000 funding to
expand CDC's Cardiovascular Health Program to 11 more states
for a total of 29 states.
We must make our science real and applicable through community
interventions that encourage Americans to make healthful lifestyle
choices to prevent heart disease and stroke.
heart and stroke research benefits all americans
Thanks to advances in addressing risk factors and in treating
cardiovascular diseases, more Americans are surviving heart attack and
stroke. Heart and stroke research and prevention breakthroughs are
saving and improving lives. Several cutting-edge examples follow.
--Emergency Cardiac Care.--Daily more than 700 Americans suffer
sudden cardiac arrest--the unexpected, abrupt loss of heart
function. A particular sequence of actions known as the ``chain
of survival'' offers hope. Early use of both breathing and
chest compression techniques of cardiopulmonary resuscitation
and delivery of a powerful electrical shock to re-start the
heart are critical to restore life. Each minute of delay in
returning the heart to its normal rhythm decreases chance of
survival by 10 percent. Our Operation Heartbeat Program, alone,
estimates that 100,000 lives could be saved if automatic
external defibrillators were more widely available.
--Advanced Imaging Technology.--Research has revolutionized imaging
technology to diagnose heart disease. You probably know someone
who has had an angiogram. In this procedure, a catheter is
inserted in an artery and navigated up to the heart. Then a dye
is injected so x-rays can show artery narrowing that can
trigger a heart attack or a stroke. About 1.2 million patients
in 1997 were hospitalized for this procedure which causes
discomfort and risk of infection and bleeding, and in rare
cases, heart attack or stroke. Now angiograms are being
replaced by two new imaging procedures that are easier, safer
and cheaper. The high speed CT scan takes fast pictures,
producing a measure of blockages in arteries to the heart, and
help doctors better tailor treatments. Three-dimensional
coronary magnetic resonance angiography (MRA), uses strong
magnets to provide detailed images of the arteries to the
heart. Taking less than an hour, MRA evaluates heart anatomy
and other heart functions, providing a comprehensive,
noninvasive, heart examination.
--Surgery to Reduce Risk for Stroke.--In many cases surgeons can
prevent stroke by removing the buildup of plaque from the main
artery to the brain that is severely narrowed. Also, it helps
stroke survivors reduce their risk of another stroke. About
140,000 procedures are performed each year.
--State-of-the-Art Life-extending drugs.--Research has produced new
drugs to help prevent and treat heart attack and stroke.
Cutting-edge drugs to control blood pressure and cholesterol
are more effective than ever in saving lives and enhancing
quality of life. When prevention fails, revolutionary
``clotbuster'' drugs can reduce disability from heart attack
and stroke by dissolving blood clots causing the attack. Use of
t-PA, within 3 hours of the onset of symptoms, can restore
blood flow through the clot-obstructed artery and reduce
chances of permanent disability by 33 percent, saving health
care costs. T-PA offers hope for the estimated 1.1 million
Americans who will suffer a heart attack and 450,000 at risk of
a clot-caused stroke this year.
So Americans can continue to benefit from these types of
breakthroughs, we support a doubling of the overall NIH budget by year
2003. We recommend an fiscal year 2001 appropriation of $20.5 billion
for the NIH, the third step toward that goal. We have a special
interest in individual NIH entities that relate directly to our
mission. Our funding recommendations for these institutes and programs
follow.
heart research challenges and opportunities for nhlbi
The above and other advances have been made possible by more than
50 years of American Heart Association-sponsored research and more than
a half-century of investment by Congress in the National Heart, Lung,
and Blood Institute. Thanks to research, no longer does a heart attack
or stroke necessarily mean immediate death. Now that more Americans are
surviving, heart attack and stroke can mean permanent disability,
requiring costly medical care and loss of productivity and quality of
life.
We urge this Committee to double the NHLBI budget, including heart
research, by year 2003. As the next step toward reaching this goal, we
advocate an fiscal year 2001 appropriation of $2.330 billion for the
NHLBI, with $1.355 billion for heart and stroke-related research. A
funding level of this amount will allow NHLBI to expand existing
programs and invest in promising new initiatives. Several challenges
and opportunities to advance the battle against heart disease are
highlighted below.
--Promoting Adherence to Medical and Behavioral Therapies.--Failure
to follow medical recommendations causes tens of thousands of
deaths a year, increased hospitalizations and delayed recovery,
costing Americans $100 billion annually. An estimated 50
percent of patients do not comply with prescribed treatments.
Many life-extending drugs for heart attack survivors and heart
failure patients are underused. Medical advances are
continually improving chances of survival for Americans who
suffer from or are at high risk of heart attack, stroke and
other cardiovascular diseases. Not all patients or doctors take
advantage of information we now know will reduce or treat
Americans at risk of heart disease or stroke. Innovative
theories about behavioral, cultural, social, psychological, and
environmental methods to increase adherence to lifestyle and
medical regimens must be tested. Research is needed on
effective indicators to measure standard of delivery of care of
health systems and to change physician behavior and practices.
Increased funding in this area will lead to development of
better methods for getting patients and healthcare providers to
adhere to cost-effective, lifesaving therapies.
--Immune System Research Programs for Heart Disease.--Basic knowledge
about the body's disease fighting system is increasing rapidly,
particularly in its involvement in the causes and development
of heart disease and stroke. Innovative approaches are needed
to use this knowledge to accelerate progress from basic
knowledge to clinical applications. Promising areas that merit
further research include, inflammatory response to blood vessel
injury that occurs in atherosclerosis (the cause of most heart
attacks and strokes); healing of damaged heart tissues after a
heart attack; and chronic rejection following heart
transplantation. Increased funding in this area would better
identify those at risk and may lead to revolutionary treatments
to prevent heart disease and stroke.
--Maintaining Weight Loss.--An estimated 106 million Americans age 20
and older are overweight or obese, a condition that increases
risk of diseases such as heart attack, stroke, high blood
pressure and diabetes. Clinical Guidelines on the
Identification, Evaluation, and Treatment of Overweight and
Obesity in Adults, supported by NHLBI and National Institute of
Diabetes and Digestive and Kidney Diseases, reviews evidence
that it is possible for overweight and obese Americans to lose
a large amount of weight over six months, but only a few
maintain it. Increased funding is needed to start studies to
improve understanding of weight loss maintenance. Researchers
must examine behaviors that influence obesity, weight loss and
weight loss maintenance.
--Heart attack, stroke and other cardiovascular diseases in women.--
Cardiovascular diseases remain a main cause of disability and
the No. 1 killer of American females, killing more than 500,000
a year. Cardiovascular diseases kill more females than the next
14 causes of death combined. They kill more females than males.
About 1 in 5 females live with consequences of cardiovascular
diseases. The clinical course of cardiovascular disease is
different in women than in men and current diagnostic
capabilities are less accurate in women than in men. Once a
woman develops a cardiovascular disease, she is more likely
than a man to have continuing health problems and is more
likely to die from it. Despite the seriousness of these
diseases, they are largely unrecognized by both women and their
doctors. Additional funding is needed to allow NHLBI to expand
research on cardiovascular diseases in women and to create more
informational and educational programs for female patients and
health care providers on cardiovascular diseases risk factors
as authorized under Public Law 105-340, the Women's Health
Research and Prevention Amendments of 1998.
stroke research challenges and opportunities for ninds
Stroke is a major cause of disability and America's No. 3 killer.
America's 4.4 million stroke survivors often face debilitating physical
and mental impairment, emotional distress and overwhelming medical
costs. An estimated 600,000 Americans will suffer a stroke this year.
Considered a disease that strikes our grandparents, stroke also
afflicts newborns, children and young adults. More Americans are dying
from stroke than ever before.
We urge a doubling of the stroke research budget through the NINDS
by year 2003. An fiscal year 2001 appropriation of $1.184 billion for
NINDS, with $125 million for stroke research, the next step toward the
goal, will allow the NINDS to expand studies and start new research to
prevent stroke, protect the brain during stroke and enhance
rehabilitation. Some challenges and opportunities follow.
--Emerging Stroke Risk Factors.--Many Americans are controlling major
stroke risk factors, such as high blood pressure and smoking,
yet the number of people falling victim to stroke continues to
rise. With the growing number of strokes, scientists are
defining new stroke risk factors, re-examining existing ones
and reconsidering a long-held belief that no difference exists
in risk between young and older patients with similar risk
factors. Researchers are studying heart valve disease coupled
with an irregular heartbeat; elevated white blood cell count
that signals an infection leading to inflammation and clogging
of arteries; long-term effects of previous high blood pressure;
and high levels of C-reactive protein in blood that signals
inflammation of blood vessels. Increased funding to study these
areas may lead to new ways to prevent stroke.
--Therapeutic Strategies for Stroke.--Several major clinical trials
investigating drugs and techniques have identified progressive
methods for preventing and treating stroke in high risk
populations. But, more drugs and procedures to prevent strokes
need to be developed and evaluated. Funding for new clinical
studies are crucial for advancing additional cutting-edge
stroke treatment and prevention.
--Public and Professional Education for Stroke.--T-PA is the first
effective FDA-approved emergency treatment for clot-caused
stroke. Yet, only 5 percent of those eligible for t-PA receive
it. As a member of the Brain Attack Coalition, a group of
national organizations committed to fighting stroke, we are
working with NINDS to increase public awareness of stroke
symptoms and appropriate emergency action. Together, we are
sponsoring and distributing a televised PSA on this issue and
striving to develop systems to make t-PA readily available to
appropriate patients. When these systems are fully implemented,
stroke treatment will change from supportive care to early
brain-saving intervention. More funding is needed to educate
the public about stroke symptoms and the need for prompt
treatment and to assure appropriate community response systems
are in place. More health professionals must be educated about
t-PA and the need for rapid response.
--Acute Stroke Treatment Centers.--Rapid, early treatment must be
available to stroke victims who arrive in the emergency
department within the three-hour window of opportunity for t-
PA. Funding to develop acute stroke treatment centers is key to
rapid early treatment. These centers would provide 24-hour
emergency transportation, emergency department physician and
nurse, a neurologist or stroke specialist, access to a
diagnostic neuroradiologist or stroke professional with
experiencing in reading and interpreting brain images and a
neurosurgeron for treatment of bleeding stroke and serious
complications. The centers would provide an opportunity for new
stroke treatments to be evaluated early when they could have
the most beneficial effect.
research in other nih institutes benefit heart & stroke
National Institute on Aging defines how the aging process
contributes to cardiovascular diseases, a main disabler and No. 1
killer of older Americans. An fiscal year 2001 appropriation of $62
million for cardiovascular research will allow continuation of studies
and expansion into promising areas.
National Institute of Diabetes and Digestive and Kidney Diseases
studies help in reducing cardiovascular disease death and disability.
We advocate an fiscal year 2001 appropriation of $1.313 billion for the
NIDDK to advance research to help diabetics, 2/3 of whom die from heart
disease or stroke.
National Institute of Nursing Research studies play a key role in
promoting self-care and patient education. NINR research is critical to
primary and secondary prevention of heart attack, stroke and other
cardiovascular diseases. We advocate an fiscal year 2001 appropriation
of $103 million for the NINR.
Animal research is critical for heart and stroke research. We
support an fiscal year 2001 appropriation of $776.3 million for the
National Center for Research Resources to help institutions and
researchers get animals and provide humane care. Increased resources
will fortify animal research, help correct deficiencies in research
animal resources and strengthen Clinical Research Area Centers and
Biomedical Technology and Infrastructure Areas.
agency for healthcare research and quality
AHRQ, the lead health care quality agency, acts as a ``science
partner'' with public and private health care sectors in improving
health care quality, reducing its costs and broadening access to
essential services. AHRQ is an active participant in developing
evidence-based information needed by consumers, providers, health plans
and policymakers to improve health care decision making. We concur with
the Friends of AHRQ's recommendation of an appropriation of $300
million for the AHRQ to improve health care quality, reduce medical
errors and expand availability of health outcomes information.
centers for disease control and prevention
The best way to protect the health of Americans and lessen the
enormous financial burden of disease is through prevention. Your
commitment cannot stop at the laboratory door. You must fund the work
that brings research into the places where heart disease and stroke
live--the towns and neighborhoods that populate America.
The CDC builds the bridge between what we learn in the lab and how
we live in communities. CDC sets the pace on prevention. We recommend
an fiscal year 2001 appropriation of $4.1 billion for CDC, with a
doubling of the chronic disease prevention line for at total of $570
million.
As a result of the efforts of this Committee, since fiscal year
1998, CDC's Cardiovascular Health Program will cover 18 states. This
initiative allows states to design/and or implement programs to meet
local needs to prevent and control heart attack, stroke and other
cardiovascular diseases. In 1997, CDC released a report outlining what
the nation's priorities should be in chronic disease prevention. The
report, Unrealized Prevention Opportunities: Reducing the Health and
Economic Burden of Chronic Disease, said ``strong chronic disease
prevention programs should be in place in every state to target the
leading causes of death and disability in our society --and their
principal risk factors.'' Until the Appropriations Committee started a
comprehensive Cardiovascular Health Program in fiscal year 1998, the
CDC-administered Preventive Health and Health Services Block Grant was
the only source of federal funding to states for targeting
cardiovascular diseases, the No. 1 killer in every state.
We laud this Committee's creation and expansion of a state-based
cardiovascular health program that will be in 18 states in fiscal year
2000. An fiscal year 2001 appropriation of $50 million for the
Cardiovascular Health Program will allow CDC to expand it to 11 more
states for a total of 29 states.
The WISEWOMAN Program uses CDC's National Breast and Cervical
Cancer Early Detection Program to also screen uninsured and low-income
women age 50 and older for heart disease and stroke risk factors. We
commend this Committee for providing funding to expand the program to
seven states. An appropriation of $20 million will allow CDC to support
20 states in WISEWOMAN.
The Preventive Health and Health Services Block Grant is a vital
resource for states in addressing heart disease and stroke. It is
critical in helping states with their role in preventing chronic
diseases. We recommend an fiscal year 2001 appropriation of $210
million for the PHHSBG. We urge the Committee to address, as the
Unrealized Prevention Opportunities document points out, the need to
target risk factors. We support CDC's efforts to build:
--a comprehensive nutrition and physical activity program with an
appropriation of $30 million;
--a national program to prevent tobacco use, including a public
education campaign to reduce youth access to tobacco, through
CDC's Office of Smoking and Health with an appropriation of
$130 million; and
--a comprehensive school health education program with an
appropriation of $25 million.
Coupled with a nationwide Cardiovascular Health Program, these
initiatives will advance the fight against heart disease and stroke. We
urge you to make cardiovascular health a national priority.
action needed
Significantly increasing resources for research and community
intervention programs will allow this nation to continue making strides
in the battle against heart attack, stroke and other cardiovascular
diseases.
______
National Institutes of Health
Medical Research
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 2001
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
appreciate your consistent support.
national institutes of health (nih)
AWHONN joins many others in supporting a 15 percent increase for
the National Institutes of Health in fiscal year 2001. With the
leadership provided by this Subcommittee, Congress is well on its way
to doubling NIH funding by 2003. In addition to the overall support,
there are two specific funding recommendations that AWHONN recommends
within NIH.
National Institute of Nursing Research
AWHONN encourages this Subcommittee to support the professional
judgement budget request of $110 million for the National Institute of
Nursing Research (NINR).
One of AWHONN's top priorities is a $20 million dollar increase in
funding for the National Institute of Nursing Research (NINR). NINR
engages in significant research affecting areas such as: research on
health disparities in ethnic groups, training opportunities in genetic
research and in health disparities, and studying telehealth
interventions in rural/underserved populations. These research programs
directly affect patients and families and contribute to decreased
medical costs and increased quality of patient care.
In addition, NINR research improves outcomes for women and
children. A report by the U.S. Agency for Health Care states that the
most common reason for hospital admission in the United States is
childbirth. This accounts for 3.8 million annual hospital admissions.
This is a joyous event in most women's lives, but complications of
pregnancy such as pre-term birth and low birthweight infants are some
of the more expensive reasons for hospitalization. Nurse research has
helped redesign care delivery models that optimize pregnancy outcomes
and shorten hospital stays for vulnerable low birthweight babies.
For example, NINR-funded projects have contributed to breakthroughs
in nursing that have improved infant health after hospital discharge
for at-risk mothers and babies. One model utilized home follow-up
assessment and care by an advanced practice nurse and showed decreased
health system costs by shortening the length of stay of the infant and
avoiding subsequent re-hospitalization.
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 the professional judgment budget, which includes an
increase of $294 million, bringing the appropriation for NICHD to just
over $1 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.
On specific example of the important research that evolves from
NICHD is research that led to the remarkable reduction in the rate of
HIV transmission from mother to infant during pregnancy and birth. In
fact, this past year, grantees focused on treatment that reduces the
viral load during pregnancy finding that the risk of HIV transmission
from mother to infant can be further reduced. Additionally, NICHD, in
collaboration with NIAID, is now conducting studies to evaluate whether
nevirapine, administered during the time a mother is breastfeeding can
reduce the rate of HIV transmission through breast milk. The results of
these studies and many others will lead to significant advances in
ensuring that babies are born healthy, while decreasing maternal
morbidity.
department of health and human services
Nurse Education Act (NEA)
AWHONN is requesting an increase of 15 percent over fiscal year
2000 to fund the NEA at approximately $78 million. Fiscal year 2000
funding for the NEA was $67.8 million.
The Nurse Education Act (Public Health Service Act Title VIII)
helps 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 addition,
funds from the Nurse Education Act support projects that would increase
educational opportunities for minority nurses who would then be able to
provide culturally competent, linguistically appropriate health care
services to underserved communities.
AWHONN supports the continued designation of funds for education
and training of critically needed primary care providers--advanced
practice nurses. These nurses--clinical nurse specialists, nurse
practitioners and certified nurse-midwives--have historically provided
a pool of qualified providers for underserved communities. Advanced
practice nurses are providing services in communities where physician
services are sometimes not even available. Due to the current demand
for these services, and expected increases in demand, it is critical
that the Division of Nursing, through the Health Resources Services
Administration, is provided the funding to address the education and
training needs of this essential pool of providers.
While many advance practice nurses are providing greatly needed
services in critical areas, the nursing community is facing shortages
in nurses with the competence, skills and experience to meet the
demands for complex patient care. With greater frequency we are
receiving calls from our members reporting gaps in staffing resulting
from fewer and fewer available professional registered nurses. We
understand that at this time the nursing shortage is regional in
nature, but the entire nursing community is anticipating a significant
professional nurse shortage to peak around 2010. With the increasing
technical complexity of the health care system, it is critical that a
pool of highly skilled and experienced professional nurses be available
to safeguard the health of our nation. We anticipate that the aging
baby boomer generation will require more health care resources in 2010
at the time when there will be a historic low in nurse supply. While we
wait for the results of the most recent nurse sample survey to confirm
these concerns, AWHONN believes it is critical that Congress act to
ensure the continued supply of professional nurses in our nation.
Maternal and Child Health Block Grant
Because of the increasing demands for the services provided through
this block grant, AWHONN recommends a substantial increase for the
Maternal Child Health Block Grant to $800 million for fiscal year 2001.
This program provides comprehensive, preventive care for mothers
and young children, as well as an array of coordinated services for
children with special needs. 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 to improve the prenatal health-related behavior of women
and reduce rates of child abuse and neglect as well as maternal welfare
dependence. Postpartum home visits can also increase the percentage of
mothers who choose to breastfeed. Many new mothers can get frustrated
and stop breastfeeding in the first few days; a visit from a qualified
health care provider can greatly encourage women to continue
breastfeeding. This can also positively impact the goals of the Healthy
People 2010 initiative to raise the rate of initiation of breastfeeding
to 75 percent and the six-month rate of breastfeeding to 50 percent.
centers for disease control and prevention--folic acid awareness
AWHONN recommends an increase to $20 million in the fiscal year
2001 appropriation to enable CDC to effectively promote folic acid
awareness.
For over 30 years, the Centers for Disease Control and Prevention
(CDC) has been deeply involved in the prevention of birth defects. The
public health impact of birth defects is tremendous. Of the four
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.
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\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.
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The first steps in preventing birth defects includes surveillance,
to find out what types of birth defects are occurring, how often and
where, and research into the causes of birth defects. The ultimate goal
of surveillance and research is to develop and implement strategies to
prevent birth defects. An example of such a prevention activity is the
current folic acid education campaign to prevent neural tube defects
(NTDs). Each year in the United States, an estimated 2,500 babies are
born with NTDs, birth defects of the brain and spinal cord, such as
anencephaly and spina bifida. These NTDs are among the most serious,
costly and preventable birth defects. The lifetime cost of each case of
spina bifida in 1992 was estimated to be nearly $300,000. Yet, up to 70
percent of NTDs can be prevented if all women of childbearing age
consume 400 micrograms of folic acid daily, beginning before pregnancy.
In an effort to spread this information, AWHONN is working closely
with the CDC, March of Dimes, and more than 40 public and private
organizations, to coordinate a national educational campaign through
the National Council on Folic Acid. Last year Congress increased
funding for CDC's efforts in support of the folic acid campaign from
$1.5 to $2 million. However, current funding is woefully inadequate. We
respectfully request that you provide the CDC $20 million in funding to
prevent these serious birth defects.
Thank you for the opportunity to submit testimony on these critical
areas of funding.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM), representing over
42,000 researchers and clinicians, recognizes with appreciation
Congress' historically strong support of medical research funded by the
National Institutes of Health (NIH), which is critical to improving the
health and well-being of all Americans. The ASM particularly commends
the leadership of Senators Specter and Harkin and the members of the
Senate Subcommittee on Labor, Health and Human Services, Education and
Related Agencies for providing a $17.8 billion appropriation for NIH in
fiscal year 2000. This investment in basic and clinical research will
lead to further advances in disease diagnosis, treatment and
prevention.
As an organization knowledgeable about public health threats, the
ASM recommends that Congress increase the proposed fiscal year 2001
budget request for NIH to provide additional resources for basic and
clinical research to address an increasingly complex set of scientific
and medical challenges. The ASM endorses a $2.7 billion increase (15
percent) which would bring the NIH budget to $20.5 billion in fiscal
year 2001. During the past two years, Congress has increased the NIH
budget by 15 percent each year, steps toward the goal of doubling the
NIH budget by 2003 \1\.
---------------------------------------------------------------------------
\1\ The ASM is a member of the Ad Hoc Group for Medical Research
Funding and endorses the Ad Hoc Group's recommendation for NIH funding
for fiscal year 2001.
---------------------------------------------------------------------------
One of the NIH's highest priorities is the funding of medical
research through research project grants, which generate new scientific
knowledge and opportunities. Under the proposed fiscal year 2001
budget, the NIH estimates that it would support 7,641 new and competing
grants, a disturbing 1300 fewer grants than awarded in the current
fiscal year. In addition, noncompeting and competing grants would be
allowed only a 2 and 2.1 percent inflation increase, respectively, well
below the 3 percent normally allowed and certainly well below general
inflation rates.
public health needs
There is no doubt that public health has benefited, not only in the
United States but around the world, from bipartisan support for
scientific research. The U.S. public expects and deserves, real
advances in medicine and science. Through research funding, the NIH
consistently contributes to our national health and to a real return on
the public's financial investment. Advances from NIH supported research
in the past year alone include the identification of a gene in
salmonella bacteria linked to pathogenicity and present in many other
disease-causing bacteria, suggesting innovative approaches to
antibiotics and vaccines. NIH supported scientists also demonstrated
that an inexpensive and simple treatment regimen with the
antiretroviral drug nevirapine can reduce transmission of the HIV virus
from mother to infant. These and other impressive successes must
continue in the fight against infectious and chronic diseases and other
threats to public health.
Infectious diseases remain the third largest cause of death in the
United States, and a number one killer worldwide. Globally, acute
respiratory infection is the leading infectious killer, responsible for
3.5 million deaths in 1998. Pneumonia and influenza are the leading
infectious killers in the United States, ranked 5th in preliminary data
for 1998. In an age of medical miracles, stubborn infectious diseases
such as malaria persist, new infectious diseases such as hantavirus are
emerging and old infectious diseases such as tuberculosis (TB) are
reemerging. One-third of the world's population has latent TB and
multi-drug resistant TB cases have been reported from 45 states over a
5 year period. The disease is the 8th leading cause of death worldwide,
and on the rise in this country. Another ``old'' disease, malaria, is
undergoing a global resurgence, with 275 million cases annually
resulting in an estimated 1.1 million deaths. In the United States, an
estimated 271,000 people are living with HIV infection, while the
hepatitis C virus (a cause of cirrhosis and liver cancer) has infected
almost 4 million and kills about 9,000 annually. In the United States,
the rate of new HIV/AIDS infections is 40,000 per year, and over
420,000 people with AIDS have died as of June 20, 1999. The HIV/AIDS
epidemic will soon become the worst epidemic of infectious diseases in
recorded history, with over 16 million people estimated to have already
died from AIDS at the end of 1999 and 33.6 million living with HIV/AIDS
worldwide. Vaccines against both viruses are desperately needed.
As a nation, global health should be a high priority, for
humanitarian reasons and because of our own vulnerability. For example,
over 60 cases of West Nile virus encephalitis were detected in New York
last year, the first documented cases in the Western Hemisphere of a
virus restricted to Africa, West Asia and the Middle East.
Within the NIH, the National Institute of Allergy and Infectious
Diseases (NIAID), has responded aggressively and effectively to
microbial threats. The NIAID is the third largest component of the NIH
due to the emergence of HIV/AIDS in the early 1980s and the realization
that infectious diseases will continue to emerge unpredictably and at
times explosively. It is clear that despite the defeat of diseases like
smallpox, the dangers of infectious diseases are far from eliminated.
One of the most significant threats to public health continues
unabated, namely our inability to treat some infectious diseases
because of antibiotic resistance. Antibiotic resistance is emerging for
almost one-third of hospital acquired pathogens, as well as for many
community acquired pathogens. Newly discovered pathogens, reemerging
more virulent pathogens, with their sobering potential as bioterrorist
weapons, mean that our struggle against infectious diseases is far from
over and must be intensified.
The ASM recommends that NIH funding be increased to expand support
for research to unlock the basic mechanisms of disease, for
antimicrobial resistance, vaccine research, the infectious etiology of
chronic diseases, emerging infectious diseases, hepatitis C, Lyme
disease, opportunistic infections including tuberculosis, AIDS-related
research, and microbial gene sequencing research. This intimidating
list of microbial targets represents some of the most serious threats
to public health, but also offers exciting possibilities for scientific
advancement.
scientific progress and opportunities
As we enter the 21st century, scientific opportunities are greater
than ever, thanks to historic advances in basic and clinical research
over recent years. These opportunities promise future benefits through
new knowledge, new treatments, and new prevention strategies. We have
witnessed the power of basic research to enhance public health
manifested, for example, as effective hepatitis B vaccines or the
development of rapid diagnostic tests for specific pathogenic
microorganisms. We enter the century with new research capabilities,
with more sophisticated laboratory tools and with a scientific
workforce that is increasingly interdisciplinary in its attitudes and
abilities.
Remarkable opportunities await researchers as a result of DNA and
computer technologies developed in the latter part of the 20th century.
ASM concurs with the NIAID's strategic plan statement that ``DNA
technologies are profoundly altering the health research landscape . .
. [and] revolutionizing approaches to understanding pathogenesis,
microbial physiology, and epidemiology of infectious diseases;
radically advancing the understanding of immune activation and
regulation; uncovering the genetic bases of disease susceptibility; and
accelerating the development of new diagnostic, treatment and
intervention strategies.'' This suggests stunning returns on public
investment in basic research through the NIH. Add to these
possibilities those provided by computer modeling, robotics and x-ray
crystallography, and our future defenses against infectious diseases
will likely look quite different than those of the past century.
nature of and requirements of today's research
New technologies will be a trademark of research in the 21st
century, but they will not be the only agent of change reshaping our
scientific approach to fighting both old and new diseases. The NIH will
support the skilled personnel and the knowledge base necessary to adapt
to these changes.
Much of the research landscape has changed over the past century,
and will continue to change. Undoubtedly, scientific research will
become even more expensive. Our increasing dependence on highly
sophisticated technologies, such as advanced computers, functional
imaging, and gene chips, increases the cost of doing research. The
growing use of genetically modified animals and more elaborate animal
facilities adds significant cost, as does the obvious need for more
clinical research and clinicians participating in multi-institution
studies. Scientific advances are cumulative and research is a multi-
year process that may not produce a satisfactory product for a long
period of time. Long-term funding for research and its underpinning
infrastructure remains a necessary part of assuring scientific and
medical advances.
Among the factors reshaping how we will do research is the absolute
necessity for burgeoning data bases, innovative computer usage, and
information sharing within highly complex research projects. The NIH is
responding to this new world of information with informatics projects,
input from the National Library of Medicine, and interdisciplinary
efforts in the fields of biology, computer science, and mathematics. In
fiscal year 2001, the NIH plans to provide the infrastructure to train
the next generation of interdisciplinary scientists, to develop new
means for storing, managing, and accessing vast data collections, and
to enhance basic research in biomedical computing. To accomplish these
new approaches to research, resources must be sufficient to train
scientists in interdisciplinary fields and to encourage cooperative
efforts among specialists.
Research in the 21st century must also adapt to significant changes
in patient populations. Since the beginning of 20th century, life
expectancy at birth in the United States has increased from fewer than
50 years to more than 76 years. As a result, future research will focus
more than ever on enhancing the quality of human life. By the middle of
this new century, the number of Americans over 65 will more than double
and the number over age 85 will increase five-fold, making diseases of
the aged a higher priority for researchers. An example is our growing
awareness that microorganisms play more of a role in chronic disease
than previously thought, an area now being investigated by the NIH. A
virus has been found in spinal cords of victims of the neuromuscular
disease known as Lou Gehrig's disease. Other chronic diseases with a
possible microbial etiology include peptic ulcers, arthritis,
cardiovascular disease, conditions affecting the lungs, and some types
of cancer.
Women and minorities in the United States and around the world also
bear a disproportionate burden of many infectious diseases, including
AIDS, sexually transmitted disease, auto immune diseases and end stage
renal disease. The NIH supports research to improve the health status
of patients affiliated with these diseases.
economic benefits
Triumph over diseases that assault human health is not the only
reward from research. The financial benefits of research are
significant, through both economic stimulus and cost-savings.
Approximately 82 percent of the funds appropriated to the NIH flows
into research labs across the nation, supporting the work of more than
50,000 researchers affiliated with some 2,000 hospitals, universities,
and other research institutions. Federally supported research offers
obvious benefits to the biotechnology and pharmaceutical industries,
which utilize discoveries from basic research and in return receive
increased revenues and a steady input of opportunities for new-product
development. In 1999, more than 153,000 highly skilled workers were
employed by U.S. biotech companies, generating an impressive $19
billion in annual revenues.
The American public, however, is the greatest recipient of
scientific and medical advances. Surveys consistently show that
citizens support increased funding for medical research, in recognition
of the importance of public health and of research as the foundation
underlying success against disease. Through efforts by the NIAID there
are clear examples of direct benefits from basic research: the
identification of infectious agents for several human diseases,
including Lyme disease, bronchopneumonia, hemorrhagic fevers, and
diarrheal illness; and the genomic sequencing of the cause of syphilis,
Treponema palllidum, and of E. coli strain K 12 and Chlamydia
trachomatis, of a chromosome of the malaria parasite Plasmodium
falciparum, and of Mycobacterium tuberculosis. As a result of these
laboratory discoveries, we will develop more specific and more
effective diagnostic, treatment and prevention strategies. The
dividends from public investment in a vigorous and well-funded research
enterprise are not merely hypothetical, but very real improvements in
public health and the national economy.
The ASM appreciates the opportunity to submit written testimony to
support increased funding for the NIH in fiscal year 2001
appropriation.
______
Prepared Statement of Texas Tech University Health Sciences Center
Mr. Chairman, thank you for the opportunity to submit this
testimony for the record on a subject of utmost importance to diabetic
patients in Texas and the nation. Texas Tech University Health Sciences
Center (TTUHSC), in response to the prevalence of diabetes among the
Hispanic and elderly populations that it serves, is proposing to
establish a Center for Diabetes Prevention and Control for which TTUHSC
is seeking $6.3 million over three years. This center will engage in a
wide array of diabetes prevention and control activities including:
--Development and operation of easily accessible diabetes eye care
outreach, assessment, and treatment centers;
--Perform clinical investigations of the predisposition to infection
among diabetics, especially diabetic Hispanics; and,
--Conduct in-depth surveys that focus on Hispanics and the elderly
residents of rural areas to identify persons with undiagnosed
and untreated diabetes and to track the incidence, prevalence,
and treatment of diabetes among the general populations;
--Examine the use of telemedicine and other technologies as a means
of delivering diabetes education, consultation, and care to
patients in remote communities and rural areas.
Mr. Chairman, diabetes is one of the most physically and
financially debilitating preventable diseases facing our nation. The
number of people diagnosed with diabetes continues to increase,
especially among Hispanics and the elderly in regions like West Texas.
It is for these reasons that the Texas Tech University Health Sciences
Center (TTUHSC) seeks funding to support its diabetes efforts and to
assist the Health Sciences Center in enhancing its diabetes expertise
and facilities.
Today, an estimated 865,347 adults in Texas have diagnosed diabetes
and for every recognized diabetic there is at least one case where the
disease has not been diagnosed. The situation may be starker still for
West Texas because diabetes occurs more often in the elderly and among
Hispanics--two groups prominent in the region's population. As in the
nation, Hispanics in Texas are two to four times more likely to have
diabetes than are members of the non-Hispanic Caucasian population. It
is estimated that approximately 22 percent of elderly Hispanics suffer
from the disease. Hispanics are already the second largest and are also
the fastest growing minority group in the United States. In 1993 there
were 27 million Hispanics in the United States, representing 10 percent
of the population. By 2050 Hispanics will constitute 21 percent of the
U.S. population. In light of this demographic trend, the following
statistics on diabetes among Hispanics are indeed ominous. About 5
percent of Hispanic Americans between the ages of 20 and 44 years, and
20 percent of those between the ages of 45 and 74 years have diabetes.
These data translate to 1.8 million Hispanic adults with diabetes.
About half of those have been diagnosed, but the other half remains
undiagnosed and untreated.
The Texas Diabetes Council estimates that 35 percent of the
diagnosed diabetics in Texas are Hispanic. Studies conducted in Texas,
New Mexico and in Mexico show that the risk of having diabetes in adult
Hispanic men and women is 13 to 25 percent, compared to 3 to 8 percent
in Anglo adults.
The problem of diabetes in the Hispanic population is aggravated by
a variety of financial and non-financial barriers that limit access to
modern health care and health information. When limited access delays
diagnosis and treatment of diabetes, irreversible complications
involving the visual, renal, cardiovascular, and nervous systems are
more likely to develop. When education on ways to manage diabetes is
unavailable, the disease is much more likely to progress and to result
in needless, preventable exacerbation.
The total economic impact of diabetes in 1997 was estimated to be
$98 billion. That includes $44.1 billion in direct medical and
treatment costs and $54 billion in indirect costs attributed to
disability and mortality.
The overall annual cost of diabetes in Texas is approximately $4
billion, $1.6 billion in direct costs and $2.4 billion in indirect
costs, largely from long-term disability. The shortage of health
professionals in West Texas compounds the problem by limiting the
number of people who can screen for the disease and provide proper
care, appropriate nutrition education, and other self-management
instruction.
Additionally, diabetes is the leading cause of blindness, kidney
failure, and amputations as well as a leading cause of heart disease,
stroke, birth defects, premature death, and disability. The diabetics'
risk of renal disease, ocular disorders, and gangrene is 17 to 50 times
greater than that of the general population. Cardiovascular
complications among diabetics occur twice as often as they do among
non-diabetics. A higher incidence of complications from diabetes,
including: nephropathy, retinopathy, and peripheral vascular disease,
has been documented among Hispanics.
Kidney failure is one of the most devastating consequence of
diabetes--half of the nation's cases of End Stage Renal Disease (ESRD)
are caused by diabetes. Annual Medicare costs from ESRD total $15
billion. In West Texas, it is estimated that nearly 70 percent of all
ESRD is caused by diabetes. The extraordinarily high prevalence of
diabetes-related ESRD in TTUHSC's catchment area is due in part to its
large Hispanic and Native American populations, groups having the
highest rates of diabetes in the United States. Preventing diabetes-
related ESRD has the potential for saving billions of dollars in
Medicare costs annually.
The risk of renal disease, ocular disorders, and gangrene in
diabetics are, respectively, 17, 25, and 50 times that of the general
population. The risk of cardiovascular complications is twice that seen
in non-diabetic subjects. The overall annual cost of diabetes in Texas
is approximately $4 billion, $1.6 billion in direct costs and $2.4
billion in indirect costs, largely from long-term disability.
The proposed TTUHSC Center for Diabetes Prevention and Control will
include the following components:
Diabetic Eye Care Assessment and Treatment Center
Because diabetes is the leading cause of blindness, an Eye Care
Assessment and Treatment Center can provide greatly needed evaluation
and treatment for all types of diabetic retinopathy, particularly those
that respond to laser surgery. Comprehensive eye examinations utilizing
digital retina photography detect diabetic retinopathy, photography
coupled with angiography quantifies disease severity, and state-of-the-
art eye lasers provide sight-preserving treatment. Using public
outreach to emphasize the need for regular screenings--even when visual
loss is not apparent--centers in both El Paso and Lubbock will help
fill the need for quality eye care among the West Texans most prone to
diabetes--Hispanics and the elderly.
Population-Based Diabetes Survey
Although estimates can be derived from national surveys, hard data
are not available on either the disease's prevalence or the quality of
care provided to rural and Hispanic diabetics. Research by TTUHSC
faculty suggests that Hispanics and rural elderly are much less likely
to receive appropriate medical care than non-Hispanics. The proposed
survey would provide precise estimates of the prevalence of diabetes in
a region with substantial numbers of rural and Hispanic residents as
well as information on ethnic differences in the continuity and quality
of medical care afforded diabetics. To derive estimates of the
prevalence, along with the additional needed information, a base sample
of approximately 6,600 completed surveys will be obtained.
Diabetes Clinical Research Center
Cardiovascular disease (CVD) is the nation's leading cause of death
and diabetics have a higher incidence of CVD than do non-diabetics.
Because TTUHSC serves a region with particularly high rates of
diabetes, CVD is very prevalent among its patients. By establishing a
Diabetes Clinical Research Center, TTUHSC can better identify diabetics
at increased risk for CVD. Center investigations can also help predict
the specific form of CVD to which these patients are most prone--heart
attack, heart failure, stroke, disease of blood vessels in the legs and
arms, or kidney failure. Armed with this knowledge, physicians can
customize their patients' disease management.
Research Project: Diabetes Mellitus and Infections
Diabetics are particularly prone to infection, perhaps because of
the effects of high glucose levels and other diabetes-related changes
on the white blood cells that defend the body against infection-causing
organisms. However, definitive evidence on possible diabetes-linked
changes in the function of these blood cells is lacking.
This project will evaluate white blood cell activity in Hispanic
diabetics. Cells will be examined for possible causes of any changes in
their protective function. If compromised cellular function can be
documented, then clinical trials of medications that inhibit white cell
damage would follow. Prevention of infection and related complications
of diabetes would represent a clinical ``cure'' of the disease.
Diabetes Education Telemedicine Project
A two-year demonstration project will evaluate the medical efficacy
and economic feasibility of telemedicine as a means to deliver diabetes
education to underserved diabetics, particularly Hispanic and elderly
residents of remote, rural West Texas counties. Over a network linking
rural health facilities with TTUHSC-El Paso, a bilingual Certified
Diabetes Educator (CDE) will serve diabetics and their family members
who cannot access effective education on diabetes management.
The CDE will implement and manage the project in four rural
communities. The project will be evaluated to determine the medical
efficacy and economic feasibility of providing diabetes education and
related services to rural communities via telemedicine technology.
The funds requested for the proposed Center will allow TTUHSC to
significantly enhance it faculty expertise and expand its diabetes
prevention and control activities and facilities. TTUHSC has as its
major objectives the provision of quality education and the development
of academic, research, patient care, and community service programs to
meet the health care needs West Texas. The 108 county region served by
TTUHSC which comprise 50 percent of the state's land mass and 13.9
percent of the population of the total state. This 131,000 square mile
service area that is home to 2.55 million people has been and remains
highly underserved by health professionals and accessible health care
facilities.
This initiative brings the clinical and scientific expertise of
TTUHSC to bear on the provision of comprehensive, accessible and
affordable diabetes outreach, education, prevention and care for the
underserved and Hispanic and elderly populations of West Texas. The
proposed Center will provide a national model of diabetes outreach,
education, prevention and care. Because the region's Hispanic
population tends not to be transient, the Center can track significant
disease indicators and outcomes over a substantial period of time in a
large Hispanic sample, data available nowhere else in the United
States. Such data will be crucial for federal and state efforts to
create prevention and care programs that reduce long-term health care
costs and improve state and national health indicators. The Center's
national relevance justifies TTUHSC's request for federal support.
Mr. Chairman, we here at Texas Tech Health Sciences Center look
forward to working with you to successfully implement this initiative
over the coming three years. We are seeking $6.3 million over three
years for the complete implementation of this initiative.
Thank you for the opportunity to submit this testimony for the
record.
______
Prepared Statement of Santa Marta Hospital
Thank you Mr. Chairman for the opportunity to submit this testimony
for the written record on a very important initiative underway at Santa
Marta Hospital in Los Angeles California, The Diabetes Education and
Management Program. This initiative has been implemented in response to
one of the most critical and expensive medical crises threatening our
patients. This program will provide a national model for diabetes
education, outreach and disease for underserved and highly at-risk
populations, specifically, Hispanic Americans.
Santa Marta Hospital's three-year multi-site, Diabetes Education &
Management Program will focus on the provision of diabetes education,
outreach and health care services to an extremely at-risk, underserved
and economically disadvantaged Hispanic population. Approximately 40
percent of the target population for the Diabetes Education and
Management Program are uninsured, and live at or below the federally
defined poverty line.
This initiative will address the urgent diabetic epidemic that is
affecting the Hispanic population in Santa Marta's service area, the
State of California and the nation. This innovative community-based
program will use specially trained residents of the community to
provide educational presentations, information and outreach to the
residents of the hospital's service area. These ``Health Promoters''
who will themselves be graduates of the Diabetes Education program,
will be trained to provide screening, educational presentations,
preventative services and outreach for primary medical care to
residents of the neighborhood. The specific Objectives, Methods and
Evaluation strategies that will be implemented as part of this
initiative include:
Objectives
1. To train initially 20 (and ultimately 100 over the three year
life of the demonstration) Community Health Promoters who will then
provide diabetes education and medical services to at least 150 people
in the East Los Angeles community annually, moving to 200 people in
year three.
2. To develop 70 courses annually that will include educational
presentations addressing stages of diabetes, symptoms, nutrition and
treatment options, both in Spanish and English.
3. To provide low cost or no cost lab tests, medical care, and
diabetes treatment to members of the East Los Angeles community.
4. To expand the scope of community outreach to include a much
broader range of diabetes medical, educational and psychosocial
services provided to poor people in East Los Angeles.
Methods/Strategies to be used to meet the program objectives
1. The program will be composed of both diabetes education classes
and preventative and primary care medical services. The education
component will focus on diabetes presentations addressing symptoms,
nutrition, and treatment. Approximately 10 or 12, 12-week courses will
be offered serving approximately 30 people per class (at least 200
people per year, by year three).
2. Primary care programs will include: regular medical check-ups
and lab work, screenings for diabetes, referrals to specialized
physicians, and referrals to psychosocial services. Lab work and
medical family history will be obtained at the beginning and end of the
12-week program. Results will be compared and used as a performance
evaluation tool for the Diabetes Education & Management Program.
3. Diabetes education and management courses will be taught first
by trained hospital staff. Eventually, 20 community Diabetes Education
& Management Program participants, diagnosed diabetics themselves, will
receive 50 hours of training to become diabetes educators in order to
increase the number of people providing screenings in the community.
This will improve program effectiveness because this community responds
positively to community based programs.
4. The community outreach program will continue to be supplemented
by regular visits from Santa Marta's Mobile Health Care Delivery Van.
This mobile clinic, staffed by doctors and nurses, will provide basic
medical evaluations, testing, health education materials, and referrals
to the Diabetes Education & Management Program.
Evaluation Strategies
1. Monthly, the project Clinical Director will review progress and
present status reports to Santa Marta Hospital. The project Clinical
Director's report will list the number of people benefiting from the
education program, accomplishments, problems, corrective actions, and
campaign status.
2. At the end of each 12-week course, participants will fill out
evaluation forms assessing course effectiveness. The results will be
compiled by the project Clinical Director quarterly and presented to
the Hospital.
3. At the end of year one, the program will be thoroughly reviewed
by the hospital President & CEO to determine program effectiveness,
formulate recommendations, and make required changes to ensure its
continued success. Their report will be shared with all interested
parties, including donors and local health and social service agencies.
The Diabetes Education & Management Program will provide education,
medical and psychosocial services to people living in East Los Angeles.
The program includes: free educational classes, two free lab work
visits per participant (one at the beginning of the 12-week course and
one at the end to test compliance and program effectiveness), and low
or no cost medical services for related health effects of diabetes.
Diabetes is known to be one of the most under identified causes of
and contributions to death and that it disproportionately affects the
Hispanic population. Additionally, it is widely recognized that the
Hispanic population is three times more likely to have diabetes than
other non-Hispanic populations. Today, there are approximately 15.7
million people or 5.9 percent of the population who have diabetes.
While an estimated 10.3 million have been diagnosed, 5.4 million go
undiagnosed. Hispanics represent 12 percent to 14 percent of all
diabetes cases nation-wide. Additionally, it is estimated that
approximately 22 percent of elderly Hispanics suffer from the diabetes.
Hispanics are the second largest and fastest growing minority group in
the United States. In 1993, there were 27 million Hispanics in the
United States, representing 10 percent of the population. By 2050
Hispanics will constitute 21 percent of the U.S. population.
Ninety-seven percent of the population surrounding Santa Marta
Hospital is Hispanic.--The Hospital's census indicates that 66 percent
of its patient population suffers from undiagnosed and diagnosed
diabetes, and there are alarmingly high statistics for those who suffer
from complications such as gangrene, kidney failure, heart disease and
blindness. Of that number the Hospital estimates that it can target at
least 2,440--2,840 with its Diabetes Education and Management Program.
Located within an inner-city neighborhood plagued by poverty, gang
violence and drugs, Santa Marta Hospital is a sanctuary of hope for the
19,000 people who walk through its doors each year as well as the
955,000 who reside in its service area. Ninety percent of Santa Marta's
patients rely on Medicare and MediCal programs to access health care
services. The remainder can pay only a small portion of their hospital
expenses or rely on Santa Marta's charity care. Given the poverty of
its patients, the hospital depends on the partnership of corporations,
foundations and individual donors to fund the cost of new medical
programs and necessary major capital expenditures.
The per capita cost per diabetic admission to hospitals in
California is $8,600. This does not include non-hospital-based dialysis
and other medical supply costs; lost work time; or other societal
effects. The cost of doing nothing is $4,472,000 (520 people
$8,600), and these costs are generally supported by Medicare and
MediCal (Medicaid) reimbursement. Santa Marta's proposed program will
save Medicare/MediCal programs in California alone $2,400,000.
Given the financial ability of the affected population and the high
expense of diabetes, Santa Marta Hospital is seeking $2 million in
fiscal year 2001 for the full implementation of this needed community
based prevention, education and management initiative.
Poverty, gang violence, drug dealing, alcohol abuse, rampant teen-
age pregnancy and an exceptionally high school dropout rate are just
some of the harsh realities impacting the seven-mile area surrounding
Santa Marta Hospital. There are over 9,000 hardcore gang members and 58
established gangs who shadow the community with a constant threat of
violence. As the only Catholic Hospital in an overwhelmingly Catholic
population, Santa Marta provides a sense of sanctuary where patients
experience safety and care with dignity.
Founded in 1924, Santa Marta Hospital was originally a ten-bed
maternity hospital. Today the hospital's maternity department delivers
over 1,500 newborns each year, and coordinates Comprehensive Perinatal
Service Programs for the almost 1,000 poor pregnant women who walk
through its doors annually. The hospital expanded in 1971, and grew
into a 110-bed acute care facility offering medical services including:
Radiology, Surgery, Labor and Delivery, Nuclear Medicine, Laboratory,
Pharmacy, Cardiopulmonary, and Physical Therapy. In 1989, a 20,000
square foot, 24-hour Emergency Room Intensive/Coronary Care Unit (ICU/
CCU) transformed the hospital into a complete comprehensive medical
facility.
The hospital prides itself on offering several critical programs
that impact the health of the larger community. Santa Marta is a place
of hope and service in their community. They know that the hospital
doors are open, and that no one is ever turned away or refused care on
the basis of race, religion, gender, sexual orientation, age, national
origin, disability, or ability to pay.
Enhancing its broad range of hospital services, Santa Marta
coordinates the structure for Pediatric, Family Care, and Obstetrical
Clinics to assist overall outpatient health care. ``Health Fairs'' and
``Health Seminars for Seniors,'' reinforce the hospital's outreach to
the medically indigent with an emphasis on preventative care.
Additionally, the hospital coordinates a highly successful program for
``at-risk'' youth that has the collaboration of local area schools,
social service agencies, juvenile authorities, and youth/adult
employment programs. The program introduces teens to a professional
environment where they can explore positive, future-oriented
alternatives to the world of drugs and gang violence. Each year over
250 at-risk residents of the community work more than 9,600 hours and
are exposed to positive role models, while gaining the self-esteem
resulting from helping others in need.
In the fiscal year ending June 1999, Santa Marta Hospital treated
over 19,000 patients and wrote off more than $11 million in fee
reductions, and more than $2.1 million in charity care. The hospital
also spent nearly $900,000 in community service programs. Nearly 90
percent of Santa Marta's patients are government reimbursed cases (45
percent Medicare and 45 percent Medi-Cal). And due to extreme hardship,
the remainder are treated for a very low fee or at no charge.
Santa Marta understands well that patient education is critical.
People with diabetes can reduce their risk for complications if they
are educated about their disease, learn and practice the skills
necessary to better control their blood glucose levels, and receive
regular checkups from their health care team. Santa Marta Hospital
encourages its patients to work with them to set goals for better
control of blood glucose levels, as close to the normal range as is
possible for them. Health care education is vital.
Because people with diabetes have a multi-system chronic disease,
they are best monitored and managed by highly skilled health care
professionals trained with the latest information on diabetes to help
ensure early detection and appropriate treatment of the serious
complications of the disease. Santa Marta Hospital is proposing its
Diabetes Prevention and Management as a team approach to treating and
monitoring this disease in an extremely at-risk population.
Hospital statistics indicate that members of the East Los Angeles
community are more likely than the national average to suffer, or be at
risk of suffering from diabetes. In addition to genetic predisposition,
many community members are obese, have poor nutrition, and do not
practice strong preventative medicine. Consequences of untreated or
unmanaged diabetes include blindness, amputations, kidney failure, high
blood pressure and strained work, financial and family relations.
Remember, there is no cure for diabetes.
This initiative, at its core a twelve week program of diabetes
screening, education, and management program, will be culturally and
linguistically sensitive order to address diabetes from a prevention
perspective, preserving the health and financial resources of our
patients, our hospital, and governmental health care programs.
Santa Marta estimates that the program cost to test, educate, and
provide initial medical treatment to program participants will be
between $1,000 and $1,500, depending upon the seriousness of pre-
existing diabetes-related conditions. In 1997, the average cost of
health care for people with diabetes nationally was $10,071, as opposed
to $2,699 for individuals without the disease.
By learning to manage their diabetes, participants of Santa Marta's
Diabetes Education & Management Program can potentially eliminate days
missed from work due to diabetes, costly hospitalizations, and
permanent disability from blindness, amputation, or kidney-failure.
Given program compliance, the cost of the educational program would be
recouped in health care savings within three months. Using 1997 health
care cost data, the initiative could demonstrate $200 million savings
over a twenty-five year span.
Thank you Mr. Chairman for the opportunity to submit this
testimony. We look forward to working with you this year to secure $2
million in fiscal year 2001 to implement this very needed community
based diabetes education and management program.
______
Prepared Statement of the University of Michigan
Good afternoon. I am Gilbert Omenn, Executive Vice President for
Medical Affairs of the University of Michigan and CEO of the University
of Michigan Health System. I am an internist and a geneticist, as well
as a former Associate Director of OSTP and of OMB.
I am submitting this testimony on behalf of a coalition of over 20
academic health centers across the nation to highlight several specific
needs in the NIH budget. The recommendations which I will present have
been endorsed in various parts by the Association of American Medical
Colleges (AAMC) and the Federation of American Societies for
Experimental Biology (FASEB).
I want to thank all the Members of this Subcommittee for your
outstanding support of the National Institutes of Health. The funding
increases you have provided over the past several years have had--and
will continue to have--a significant impact on our nation's biomedical
and behavioral research enterprise. We are hopeful, even confident,
that the NIH budget will continue on the trajectory to double by fiscal
year 2003. The remarkable scientific advances from recent decades have
positioned our nation to exploit very responsibly what is certain to be
a ``golden era of biology'' for benefits in medicine, public health,
and the broader economy and society.
I seek your support for three specific items in the NIH budget that
will enhance the extraordinary partnership between academic
institutions and the federal government, representing the research
community and the investing public:
--Increase extramural construction funding so that academic
investigators supported on a project basis by NIH can have a
greater probability of access to state-of-the-art facilities to
carry out their highly valued biomedical and behavioral
research.
--Adjust the salary cap to treat extramural researchers similarly to
their colleagues in the intramural programs of NIH itself.
--Establish a peer-reviewed, flexible grant program for shared
resources to meet evolving and transitional research needs at
the institutional level, aligning the efforts of the
institutions and not just the faculty in the research agenda of
the NIH.
increase funding for facilities: construction, renovation, and
equipment
It is vitally important that we have the facilities and equipment
to fully exploit research opportunities and utilize the increased
project grant funding. Exciting developments in genomics, chemical
biology, neurosciences, cancer, and many other fields require new kinds
of equipment and facilities. Even the best minds cannot compensate for
outdated equipment and facilities.
We thank you and your Senate colleagues for including $75 million
in competitive funds for extramural construction in the fiscal year
2000 budget through the NIH National Center for Research Resources
(NCRR).
The National Science Foundation (NSF) completed a study in 1998 on
the status of scientific research facilities at U.S. colleges and
universities. This analysis generated an estimate of $3.6 billion in
deferred biomedical research construction and repair or renovation
projects. In a March 1998 report, the Association of American Medical
College (AAMC) stated that ``The government should reestablish and fund
an NIH construction authority, consistent with the general
recommendations of the Wyngaarden Committee report of 1988, which
projected at that time the need for a 10-year spending plan of $5
billion for new facilities and renovation.'' In June 1998, the
Federation of American Societies of Experimental Biology (FASEB)
reported that ``Laboratories must be built and equipped for the science
of the 21st Century. Infrastructure investments should include
renovation of existing space as well as new construction, where
appropriate.''
Thus, there is a well-documented need for several billion dollars
to rectify this situation as we ramp up the research project
investments. Such funding must come from all possible sources, of which
federal participation is a key element.
We urge the Subcommittee to provide a funding level of $250 million
for extramural construction in fiscal year 2001. The funds would be
awarded on a peer-reviewed, competitive basis and would require
institutional matching funds to leverage these NIH resources.
raise the salary cap on extramural scientists
NIH and the academic community share a major concern about
recruiting and retaining excellent clinician-investigators in
biomedical and behavioral research. These physicians typically have
considerable accumulated debt from their medical and post-graduate
training, and they have an opportunity cost in choosing research
careers. Medical schools increasingly expect them to earn their way
through clinical service and by earning support for their research time
by competing for federal grants. Both clinical practice and industrial
research opportunities offer substantial higher incomes.
As these faculty move up the ranks and develop successful careers,
they or their academic departments are penalized by a salary rate cap
imposed back in 1991. Unfortunately and, I believe, unintentionally,
Congress omitted a salary adjustment to account for inflation. Thus,
the maximum salary rate (on a 100 percent basis, prorated for the
proportion of time spent in funded research) was locked at $125,000
from 1991 through 1998. Of course, NIH pays only a portion of each
faculty member's salary, so the rate is set at competitive levels at
the institution and the vast majority are below the maximum.
Meanwhile, the NIH intramural program--through the Senior
Biomedical Research Service (SBRS)--can pay senior investigators
salaries up to $157,000 a year. This amount is roughly equal to what
the salary cap on academic researchers would be if it had been indexed
for inflationary increases over the past decade.
Congress has wisely moved, step-by-step, toward achieving
equivalent maximal salary rates for the extramural program. Starting
with fiscal year 1999, as you know, Congress established the principle
of increasing the cap by linking the salaries to the Senior Executive
Pay Scale of the Senior Biomedical Research Service, at Level III in
fiscal year 1999 and level II ($141,300 per year) in fiscal year 2000.
This process can be completed this year by setting the maximum for
senior investigators at Level I.
In sum, in order to retain the most talented academic researchers
in biomedical and behavioral research, especially clinician-
investigators, and in order to assure equity between intramural and
extramural scientists, we seek your support in raising the current
salary maximum for extramural academic researchers to Executive Level
I, or $157,000 per year.
establish a flexible institutional research fund to enhance the
efficiency of research
Government, universities, and industry observers all have called
for attention to various inefficiencies in the federal-academic
partnership. The White House Office of Science and Technology Policy
has held four hearings around the country, including the final hearing
in New York City, at which I was a speaker, to draw attention to ways
to strengthen the relationship between the federal government and
universities for research.
As you know, during the past decade, financial pressures on the
clinical enterprise of academic medical centers have intensified,
particularly so since the implementation of the Balanced Budget Act of
1997, which was on a path to generate far deeper spending cuts than
Congress intended in 1997 (partly redressed in 1999). It is
increasingly difficult to generate institutional margins to underwrite
research needs that are not covered well in the individual project
grant mechanism.
We want to enhance the impact of NIH funding by being flexible
enough to change with the science, accommodate and align ourselves with
new national priorities, and make the most of the NIH and institutional
investments in individuals throughout their careers. Glitches in
funding cycles, changes in NIH policies and priorities, needs for
research resources, and opportunities to mobilize research in new
directions could be addressed better with a modest fund in the hands of
the institutional leaders, based on competitive funding. Collaborative,
interdisciplinary research initiatives can be stimulated much more
effectively and accountably through a modest amount of flexible
resources at a level above the individual investigators.
Thus, we propose that you provide funding for NIH to establish a
``Flexible Institutional Support for Health Research'' or ``FISHR''
program. Program resources would provide institutional support for the
following priorities: to fund interdisciplinary, shared research
resources; to assist postdoctoral fellows and beginning investigators
to establish independent research projects; and to rapidly infuse
short-term resources into investigations which offer tremendous promise
for research progress.
We recommend that the NIH establish such a peer-reviewed, three-
year grant program through the National Center for Research Resources.
Grants could be in the range of $25,000 to $300,000 per year for Deans
of medical, public health, nursing, dental, and pharmacy schools which
qualify through having NIH project awards. Applications would provide
general plans for needs anticipated to evolve. Awards would permit
flexibility within the institution to determine spending priorities,
within the categories approved (as proposed above). To assure
accountability, we suggest two mechanisms: (1) a local internal review
committee, comprised of NIH-supported investigators at the institution,
to review specific proposed allocations, on a prospective basis; and
(2) a retrospective review by NIH research program staff prior to
approving eligibility to submit a competitive renewal application at
the end of the grant award period.
We urge you to include $60 million in the fiscal year 2001
appropriation for NIH to initiate this Flexible Institutional Support
for Health Research (FISHR) Program. Such annual funding would
favorably modify the impact of the recent stresses experienced by
research and academic institutions which threaten the efficiency of our
national research enterprise.
concluding remarks
Mr. Chairman, the extramural research community applauds the
bipartisan actions and commitments to increase funding for biomedical
and behavioral research through the NIH. Based on polls conducted by
Research!America, including polls in my state of Michigan, we know that
the American public strongly supports these investments and has high
expectations for payoff in new knowledge and medical and public health
innovations. We also applaud the investments in related federal
agencies, such as the Centers for Disease Control and Prevention, the
Agency for Healthcare Research and Quality, and the National Science
Foundation.
We are confident that the Congress and the NIH can enhance the
impact of the project-based investments by taking the three additional
steps we recommend: provide $250 million in fiscal year 2001 to upgrade
extramural laboratory space and instrumentation; increase the maximal
salary rate on NIH grants to Executive Level I so that extramural
salaries can match the maximum for intramural scientists; and initiate
a Program for Flexible Institutional Support for Health Research
(FISHR). Each of these steps will increase the productivity and
efficiency of the academic/government partnership in biomedical and
behavioral research and research training.
On behalf of academic health centers across the nation, I thank you
for your attention to these needs and recommendations. Best wishes to
each of you and to your families and staff members.
______
Prepared Statement of the American Physiological Society
The American Physiological Society is pleased to have this
opportunity to submit its views on fiscal year 2001 funding for the
National Institutes of Health. The APS appreciates this Subcommittee's
strong support for biomedical research, its dedicated efforts for many
years, and in particular, the extraordinary efforts that yielded 15
percent funding increases over the past two years, placing the NIH on
the path to a five-year doubling of its budget.
The American Physiological Society (APS) is a nonprofit scientific
society that seeks to integrate life sciences research and education
from the molecule to the whole organism. The APS was founded in 1887
and currently has more than 9,000 members. Our members conduct research
and educate the next generation of physicians and scientists at
colleges, universities, and medical schools throughout the U.S. Many of
our members are also engaged in research activities in industry and
government.
The APS is grateful for the $17.8 billion that Congress has
provided for the NIH for fiscal year 2000. This is a time of abundant
scientific opportunity. One emerging area of particular interest to the
APS is the new field of physiological genomics. Thanks to the
revolution in information technology, scientists have been able to
accomplish large-scale genome sequencing, and some are already working
on the analysis of these huge collections of data. With our growing
ability to analyze this data and zero in on key genes, we find
ourselves poised before a promising and challenging new era. As the
editors of the new on-line and print journal Physiological Genomics
observed in an editorial published on-line July 15, 1999, ``[T]he
enormous task of linking genes to function has now begun.'' The editors
go on to explain that our current state of knowledge now permits us to
trace biological processes from the first actions of genes within the
nucleus of cells through cellular processes, the influence of specific
genes upon the functions of tissues and organs and, ultimately, their
impact on the workings of the whole organism. Conducting such studies
on individual genes and gene combinations responsible for particular
diseases will permit us to identify how the internal environment
defined by our genetic makeup interacts with external influences to
keep us healthy or make us sick. The promise of physiological genomics
is that this knowledge will point the way to new therapies, diagnostic
tools, and better overall health management.
The APS offers this as an example of how NIH-funded research is
leading us toward a treasure trove of medically useful knowledge. The
APS joins with the Federation of American Societies for Experimental
Biology and the Ad Hoc Group for Medical Research Funding in urging
Congress to provide a $2.7 billion or 15 percent increase in fiscal
year 2001 as the third step toward doubling the NIH budget by fiscal
year 2003.
______
Prepared Statement of the American Chemical Society
The American Chemical Society (ACS) would like to thank Chairman
Arlen Specter and Senator Tom Harkin for the opportunity to submit
testimony for the record on the Departments of Labor, Health and Human
Services, and Education Appropriations bill for fiscal year 2001.
As you may know, ACS is a non-profit scientific and educational
organization, chartered by Congress, representing 161,000 individual
chemical scientists and engineers. The world's largest scientific
society, ACS advances the chemical enterprise, increases public
understanding of chemistry, and brings its expertise to bear on state
and national matters. ACS firmly believes that no investment the
government makes generates a higher rate of return for the economy than
research and development (R&D). In fact, economic experts maintain that
today's unprecedented economic growth would not have been realized but
for the substantial research investments by the public and private
sectors over the past few decades. Looking ahead, the American Chemical
Society (ACS) is concerned that constant dollar declines in federal
support for basic research over the past decade, particularly in the
physical sciences, have weakened the roots of innovation in all fields
and put future economic growth at risk. In order to sustain our
technological leadership and living standards, increased funding for
basic research should be a top priority for use of the non-Social
Security budget surpluses. As a framework for increasing R&D funding,
ACS supports doubling federal spending on research within a decade, as
well as balanced funding among different areas of science.
national institute of health budget recommendations
ACS commends Congress and the administration for the 15-percent
increase last year for the National Institutes of Health (NIH) and we
support a comparable increase for fiscal year 2001. As the major
supporter of biomedical research in the United States, NIH is the
primary source of new biomedical discoveries that are leading to
longer, healthier lives as well as reduced health-care costs due to
prevention, early detection, and more cost-effective treatment of
disease. An example of the enormous return on this investment is the
recent decline in both the incidence of cancer and the mortality rate
from it. In addition, NIH-supported research provides training for new
scientists, stimulates technological advances in the pharmaceutical and
biotechnology industries--both of which contribute positively to the
balance of trade--and makes the United States a world leader in
biomedical research.
national institute of general medical sciences
As the largest source of federal funding for basic research, NIH
should leverage its investments in biomedical research by maintaining
strong support for all areas of basic research critical for sustained
advances in public health and quality of life. Strong support for
chemistry and the other physical sciences that underlie or complement
biomedical research must be maintained if cutting-edge biomedical
discoveries are to continue. For this reason, ACS believes it is
essential that the National Institute of General Medical Sciences
(NIGMS) receive increases proportional to the other NIH institutes.
NIGMS supports quality, non-disease specific basic research and
training that underpins advances in other institutes. NIGMS plays a
central role in generating basic knowledge across science disciplines,
strengthening the roots of innovation in the biomedical community, and
fostering tomorrow's breakthrough discoveries.
national center for research resources
The National Center for Research Resources (NCRR) supports the
state-of-the-art research infrastructure necessary to provide high-
quality biomedical and behavioral research, including the expansion,
remodeling, and construction of extramural research facilities. The
Center facilitates the development of new technologies and techniques
by which scientific inquiry can be undertaken. In addition, NCRR
provides grants such as the Shared Instrumentation Grants program,
which provides a cost-effective mechanism for groups of NIH-supported
investigators to obtain commercially available, technologically
sophisticated equipment costing more than $100,000. Through these
contributions, NCRR offers the potential for revolutionary approaches
to health-related research.
Strong and steady support for cutting-edge researchers that
advances human health is absolutely essential to ensuring the large
return investment made on NIH research over the past decade. Sustained
growth in funding for NIH is needed to build upon past scientific
achievements, address present medical needs, and anticipate future
health challenges. Volatility and significant fluctuations in funding
can be as harmful to the research enterprise as inadequate growth.
______
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 is the world's largest
private voluntary health agency devoted to the concerns of all those
affected by MS. Throughout the Society's 53-year history, our number
one priority has been research to understand MS and apply this
knowledge to the development of new treatments and a cure.
Cumulatively, the Society has expended over $260 million in research
funds in the United States and abroad. Our current annual budget for
research exceeds $20 million. This represents the largest privately
funded program of basic, clinical, and applied research and training
related to multiple sclerosis in the world.
multiple sclerosis
MS is an often progressive, degenerative disease of the central
nervous system, unpredictable in its course, and devastating in its
effects. It can cause spasticity, tremor, abnormal fatigue, bladder and
bowel dysfunction, visual problems and mobility impairment. The disease
usually is diagnosed between the ages of 20 and 40--but is life long.
Many people with MS live thirty years or more with constant
unpredictability and increasing disability. MS affects more than twice
as many women as men, can result in loss of employment and loss of a
place in society and the community. Recent studies sponsored by the MS
Society show that the annual cost to each affected individual as a
result of MS averages $34,000, and the total cost can exceed $2 million
over an individual's lifetime. For all people with MS in the United
States--some third of a million individuals--the annual cost is nearly
$9 billion. Ending the devastating medical, personal and financial
effects of this unpredictable disease is completely dependent upon the
discovery of safe and effective treatments that halt progression of the
disease and reverse its symptoms.
recommendations for funding
NIH plays the major role in maintaining our country's preeminence
in biotechnology and provides worldwide leadership in health research
and discovery. The National MS Society recognizes that new discoveries
and breakthroughs could come from any area of biomedical research and
could apply to the primary concern of our members: finding new
treatments and eventually a cure for MS. Therefore we encourage
Congress to focus on NIH as a whole and on agencies of particular
relevance to our concern, knowing that a well-funded federal research
enterprise will benefit all of us.
The National Multiple Sclerosis Society believes that in order to
take advantage of current opportunities in biomedical and
rehabilitation research, Congress must continue the trend of the last
two budget cycles. A further 15 percent increase in NIH funding for
fiscal year 2001 would bring us closer to doubling the NIH budget over
the five-year period 1999-2003. In order to pursue cutting edge
research, the Society recommends that this translate into a parallel 15
percent increase for the National Institute of Neurological Disorders
and Stroke, the National Institute of Allergy and Infectious Diseases
and the National Center for Medical and Rehabilitative Research, the
primary institutes that conduct nearly all of the MS-related research
undertaken by the Federal Government.
neuroscience center
The NIH budget proposal for fiscal year 2001 includes $73 million
over two years for construction of a new National Neuroscience Center
at NIH. The Center will bring together in one facility, with necessary
new lab space, both basic and clinical intramural scientists from the
many institutes involved in neuroscience in order to encourage their
interaction and the translation of basic research findings. The Center
will emphasize important cross cutting themes such as
neurodegeneration, regeneration and repair of neurons, neurogenetics
and pain research. Federal funding for the Center would increase the
pace of discovery in all areas of neuroscience and help translate
laboratory discoveries into new and effective treatments for patients.
The proposed funding is included in NIH's Building and Facilities
budget, and it is our understanding that it will not affect funding for
research. The National MS Society recommends fully funding the proposed
National Neuroscience Center at NIH.
strategic analysis of ms research
The National MS Society has commissioned the National Academy of
Sciences/Institute of Medicine (NAS/IOM) to undertake a strategic
analysis of basic and clinical research for multiple sclerosis. The
NAS/IOM will review current knowledge about the cause and treatment of
MS and recommend a strategic plan to guide future investment. The study
will be broadly based, assessing current and future contributions from
private and governmental organizations, both in the U.S. and aboard. An
important goal of the study will be to identify areas of research that
may not have been exploited in the past and to identify new fields of
research. At the completion of the study, we anticipate a set of
recommendations for future strategies that can be considered not only
by the NMSS, but also other MS societies around the globe, governmental
funding agencies, and by pharmaceutical and biotech companies involved
in MS programs. The analysis was initiated in May 1999, and should be
completed early in 2001. We look forward to the opportunity to report
the results to the Subcommittee in our testimony next year.
summary
The National MS Society recognizes that new discoveries and
breakthrough findings could come from almost any area of biomedical
research and could apply to the primary concern of our members: finding
a cure for MS. We thus encourage Congress to focus on NIH as a whole,
and on agencies of particular relevance to our concern, knowing that a
well-funded federal research enterprise will benefit all of us.
Continuing the 15 percent annual increase in funding through 2003 is an
extraordinarily good use of federal resources, and we encourage you to
do whatever you can to make this a reality. In addition, in order to
take advantage of potential discoveries in all areas of neuroscience
and help translate these discoveries into new and effective treatments
for patients, we recommend fully funding the proposed National
Neuroscience Center at NIH.
______
Prepared Statement of New York-Presbyterian Hospital
I am Dr. Herb Pardes, President and CEO of New York-Presbyterian
Hospital. For the last several years, I was Dean of the College of
Physicians and Surgeons of Columbia University in New York. I submit
this testimony on behalf of academic health centers across the nation
that play a vital role in advancing the frontiers of medicine by
conducting extramural NIH biomedical and behavioral research.
We in the academic health community urge you to improve this
academic/federal partnership by recognizing the following three
concerns which limit the extramural biomedical and behavioral research
community from operating at optimal capacity and efficiency:
--the need for state-of-the-art facilities to carry out the
increasing volume of federally-supported biomedical and
behavioral research;
--the need for competitive salaries for extramural researchers; and
--the need for a peer-reviewed, flexible grant program for shared
resources to meet evolving and transitional research needs at
the institutional level.
increase funding for facilities-construction, renovation, equipment
Exciting developments in genomics, chemical biology, neurosciences,
cancer, and many other fields require new kinds of equipment and
facilities. Even the best minds cannot compensate for outdated
equipment and facilities. It is vitally important that we have the
facilities and equipment to fully exploit research opportunities and
utilize the increased project grant funding.
The National Science Foundation (NSF) completed a study in 1998 on
the status of scientific research facilities at U.S. colleges and
universities. This analysis generated an estimate of $3.6 billion in
deferred biomedical research construction and repair or renovation
projects. In a March 1998 report, the Association of American Medical
College (AAMC) stated that ``The government should reestablish and fund
an NIH construction authority, consistent with the general
recommendations of the Wyngaarden Committee report of 1988, which
projected at that time the need for a 10-year spending plan of $5
billion for new facilities and renovation.'' In June 1998, the
Federation of American Societies of Experimental Biology (FASEB)
reported that ``Laboratories must be built and equipped for the science
of the 21st Century. Infrastructure investments should include
renovation of existing space as well as new construction, where
appropriate.''
My colleagues and I urge you to provide the NIH with $250 million
for extramural facilities construction in the fiscal year 2001 Labor/
HHS/Education funding bill. The funds would be awarded on a competitive
basis, requiring institutional matching to leverage the NIH resources.
raise the salary cap on extramural scientists
Another case of cost-shifting by the Federal Government is the cap
on salaries for academic researchers. Since the cap was first imposed
in the early 1990s, at roughly $125,000 a year, the Consumer Price
Index has risen more than 20 percent. The result is two-fold. Academic
medical centers and universities have been increasingly forced to bear
more of the costs of investigators' salaries; and many promising
researchers have been driven out of academic research altogether, drawn
by more lucrative posts in the private sector.
Physician investigators are critical to translating the substantial
fundamental scientific advances to patients. Additional years of
postgraduate training, after physicians receive their MD degree, are
required for board eligibility, independent of research training and
career development. Newly trained MDs are incurring insurmountable
debts as a result. In 1997, nearly half of all medical school graduates
held debts greater than $75,000. Mounting debts combined with the
salary cap serve as disincentives for the youngest and brightest
physicians from pursuing careers in academic research. The results are
dramatic and disturbing: Between 1994 and 1997, the number of MDs
submitting new grant applications to the National Institutes of Health
dropped by more than 32 percent.
At the same time, the National Institutes of Health has created new
mechanisms such as the Senior Biomedical Research Service (SBRS) to
keep its most talented intramural scientists on the NIH campus. Under
the SBRS, the NIH can pay its senior investigators up to $157,000,
(Executive Level I) roughly equal to what the salary cap on academic
researchers would be if it were indexed for inflationary increases over
the past decade.
In fiscal year 1999, Congress tied the extramural salary cap to
Level III of the Executive Pay Scale, which--at that time--was
$125,900. Thus, the increase was not significantly above the previous
cap of $125,000. In fiscal year 2000, Congress raised the salary cap
from Executive Level III to Executive Level II (now $141,300). While
this takes into account increases in the cost-of-living over the past
decade, the extramural salary cap is still not on par with intramural
NIH scientists who can receive a maximum salary of Executive Level I.
I urge you to raise the current cap on academic researchers should
to Executive Level I ($157,000/year) to match the cap currently imposed
by the NIH on its own senior scientists under the Senior Biomedical
Research Service.
establish a flexible institutional research fund to enhance the
efficiency of research
A third concern to our nation's academic medical institutions is
inefficiency in the federal-academic partnership. As you know, during
the past decade, financial pressures on the clinical enterprise of
academic medical centers have intensified, particularly so since the
implementation of the Balanced Budget Act of 1997 during the past year.
It is increasingly difficult to generate institutional margins to
underwrite research needs that are not covered well in the project
grant mechanism.
These funds would be used to enhance the impact of NIH funding by
being flexible enough to change with the science, accommodate changing
national priorities and make the most of the NIH and institutional
investments in individuals throughout their careers. Glitches in
funding cycles, changes in NIH policies and priorities, needs for
research resources, and opportunities to mobilize research in new
directions could be addressed better with a modest fund in the hands of
the institutional leaders, based on competitive funding. Collaborative,
interdisciplinary research initiatives can be stimulated through
resources at a level above the individual investigators.
Thus, I urge you to provide funding for NIH to establish a
``Flexible Institutional Support for Health Research'' or ``FISHR''
program. Program resources would provide institutional support for the
following priorities: to fund interdisciplinary, shared research
resources; to assist postdoctoral fellows and beginning investigators
to establish independent research projects; and to rapidly infuse
short-term resources into investigations which offer tremendous promise
for research progress.
Academic health centers recommend that the NIH establish such a
peer-reviewed, three-year grant program through the National Center for
Research Resources. Grants could be in the range of $25,000 to $300,000
per year for Deans of medical, public health, nursing, dental, and
pharmacy schools which qualify through having NIH project awards.
Applications would provide general plans for needs anticipated to
evolve. Awards would permit flexibility within the institution to
determine spending priorities, within the categories approved (as
proposed above). To assure accountability, I would suggest two
mechanisms: a local internal review committee, comprised of NIH-
supported investigators at the institution, to review specific proposed
allocations, on a prospective basis; then a retrospective review by NIH
research program staff prior to approving eligibility to submit a
competitive renewal application at the end of the grant award period.
I urge you to include $60 million in the fiscal year 2001 NIH
funding bill to initiate this Flexible Institutional Support for Health
Research (FISHR) Program. Such annual funding would favorably modify
the impact of the recent stresses experienced by research and academic
institutions which threaten the efficiency of our national research
enterprise.
concluding remarks
The Congress and the NIH can enhance the impact of the project-
based investments by taking three additional steps: increase to $250
million the funding to upgrade extramural laboratory space and
instrumentation; increase the maximal salary rate on NIH grants to
match the maximum for intramural scientists; and initiate a Program for
Flexible Institutional Support for Health Research (FISHR). Each of
these steps will increase the productivity and efficiency of the
academic/government partnership in biomedical and behavioral research
and research training.
On behalf of academic health centers across the nation, I thank you
for your attention to these needs and recommendations. Best wishes to
each of you.
______
Prepared Statement of the American Society of Mechanical Engineers
The Bioengineering Division of the Basic Engineering Group of the
Council on Engineering, American Society of Mechanical Engineers (ASME
International), is pleased to provide comments on the bioengineering-
related programs in the NIH fiscal year 2001 budget request. The ASME
Bioengineering Division is focused on the application of mechanical
engineering knowledge, skills and principles from conception to the
design, development, analysis and operation of biomechanical systems.
the importance of bioengineering
Bioengineering is an interdisciplinary field that applies physical,
chemical and mathematical sciences and engineering principles to the
study of biology, medicine, behavior, and health. It advances knowledge
from the molecular to the organ systems level, and develops new and
novel biologics, materials processes, implants, devices, and
informatics approaches for the prevention, diagnosis, and treatment of
disease, for patient rehabilitation, and for improving health. From the
perspective of mechanical engineering, bioengineering provided for the
development of the artificial heart, prosthetic joints and numerous
rehabilitation technologies, as just several examples.
the need for increased investment in bioengineering
The Bioengineering Division recommends that support for
Bioengineering Research as a percentage of the total NIH research
project grants (RPGs) budget be increased to meet the future explosion
in Biomedical Engineering Research. In addition, it recommends that a
separate, independently funded institute be established to provide
adequate support for basic Bioengineering Research.
background
NIH is the world's largest and most eminent organization dedicated
to improving health through medical science. During last 50 years, the
NIH has played a preeminent role in the major breakthroughs that have
increased average life expectancy by 15 to 20 years.
The NIH is comprised of different Institutes and Centers that
support a wide spectrum of research activities including basic
research, disease and treatments related studies, and epidemiological
analyses. The missions of individual Institutes and Centers may focus
on a particular organ (e.g. heart, kidney, eye), on a given disease
(e.g. cancer, infectious diseases, mental illness), or on a stage of
development (e.g. childhood, old age), or, may encompass crosscutting
needs (e.g. sequencing of the human genome).
Investigator-initiated RPGs continue to be one of the NIH's highest
funding priorities. In fiscal year 2001, RPGs represent 56.9 percent of
the total NIH budget, and provides $10.3 B, a 6.1 percent increase over
fiscal year 2000, to fund an estimated 31,524 research project grants.
This represents an addition of 237 grants over the fiscal year 2000
total. Total grants include non-competing grants and competing new
grants. NIH estimates it will support 7,641 competing new RPGs in
fiscal year 2001. This number is 1,309 below estimated fiscal year 2000
levels.
current investment in bioengineering is inadequate
In fiscal year 1999, Bioengineering Research Support was at $0.645
B or 7.6 percent of the total NIH RPGs budget. In fiscal year 2000,
Bioengineering Research Support is estimated at $0.661 B or 6.8 percent
of the total NIH RPGs budget. While the Bioengineering Division
acknowledges that there is a small increase in the budgeted support for
Biomedical Research, it also notes there is an actual decrease in the
percentage of funding, a trend which could indicate a decrease in
emphasis on Bioengineering within NIH.
The focus of bioengineering issues at the NIH is the Bioengineering
Consortium (BECON), which consists of intramural and extramural senior-
level representatives from each of the NIH institutes, centers, and
divisions plus representatives of other federal agencies with funding
authority for bioengineering research. BECON itself does not have
funding authority.
Because BECON is not independently funded, the individual
Institutes and Centers under the NIH umbrella must use their annual
appropriations to support bioengineering research, a practice that may
contribute to the under-funding of bioengineering research. For
example, the National Institute of Dental and Craniofacial Research's
(NIDCR) share of the total RPG NIH budget, excluding AIDS, is
approximately 1.38 percent for fiscal year 2000. Yet, it is anticipated
that NIDCR will allocate 41.28 percent of that budget, or $55.4
million, to bioengineering research, an amount representing 8.38
percent of the total RPG NIH budget for fiscal year 2000. ASME's
Bioengineering Division believes that this is indicative of the under-
investment being made in Bioengineering Research.
concerns
While ASME's Bioengineering Division supports NIH and the
priorities identified in the fiscal year 2001 Budget Request, it is
concerned about two issues: the reduction in the number of new
projects; and, the lack of a direct support mechanism for
bioengineering research.
Reduction in the Number of New Projects.--NIH estimates it will
support a total of 7,641 new and competing RPGs in fiscal year 2001.
This number is 1,309 below estimated fiscal year 2000 levels, a
reduction of 14.6 percent. This reduction appears to be inconsistent
with the theme of recruiting and training new clinical investigators,
especially in Bioengineering where the number of researchers is
increasing rapidly in Bioengineering academic departments at
universities across the nation. As an example, the number of applicants
for CAREER Awards in Biomedical Engineering at the National Science
Foundation increased from 38 in fiscal year 1999 to 55 in fiscal year
2000, an increase of 45 percent. ASME's Bioengineering Division
believes this is an early indication of the coming explosion in
Biomedical Engineering Research.
Lack of a Direct Support Mechanism for Bioengineering Research.--
Funding for Bioengineering research remains a small portion of the
total NIH research budget. BECON does not include resources for the
collaborative support of extramural research. At this time, an
intramural bioengineering research program does not exist for broad-
based, multidisciplinary research. This situation places a burden on
individual NIH Institutes, and appears to be inconsistent with the
vision of the role of Biomedical Engineering in increasing biological
knowledge, facilitating the development of novel devices and drugs, and
providing the technological means to improve health care.
recommendations
To address the concerns listed above, the ASME Bioengineering
Division recommends that:
--support for Bioengineering Research as a percentage of the total
NIH RPGs budget be increased to meet the future explosion in
Biomedical Engineering Research; and,
--a separate bioengineering research institute be established to:
provide an administrative structure to assist in the coordination,
communication, and promotion of bioengineering research
supported by the many institutes within NIH to increase the
opportunities for new collaborations, dissemination of new
technologies or research findings and the availability of
funding opportunities, special seminars, conferences, and
related activities;
have the authority and funding to provide extramural grants
specifically targeted to support activities that do not
fall within the disease-related institutes of NIH (e.g.,
proposals for the development or evaluation of generic
technologies that cross many health disciplines; training
grants for pre-doctoral and post-doctoral trainees in
bioengineering; and, funding for specialized extramural
centers which would enable universities to develop core
support structures for enhancing the training, research
endeavors and development of technology in all fields of
bioengineering); and,
support the development of a modest intramural program in
Biomedical Engineering to focus primarily on new
technologies that could evolve to become core resources for
both intramural and extramural investigators.
--as an interim measure prior to the establishment of a separate
Bioengineering Institute, the NIH create an Office of
Bioengineering Research modeled after the Office for Research
on Minority Health (ORMH) to:
serve as the coordination center within the Office of the Director
for Bioengineering Research issues; and,
have the legislative authority to award grants for priority
bioengineering research that other Institutes or Centers
are unable to fund.
conclusion
The ASME Bioengineering Division endorses the National Institutes
of Health's fiscal year 2001 budget request for bioengineering. Triumph
over disease and disability, and speeding the rate at which fundamental
discoveries are translated into effective therapies, are essential for
the vitality of this nation.
The Division is concerned about details of the budget request. To
address these concerns, the ASME Bioengineering Division recommends
that:
--support for Bioengineering Research Support as a percentage of the
total NIH RPGs budget be increased to meet the future explosion
in Biomedical Engineering Research;
--a direct support mechanism for bioengineering research be
established to provide adequate support for basic
bioengineering research, a centralized focus for extramural
bioengineering research at NIH, a strong intramural
bioengineering program at NIH, and increased coordination of
bioengineering research within the highest levels of NIH and
among other federal agencies; and,
--as an interim measure, the NIH establish an Office of
Bioengineering Research based on the ORMH model.
ASME International's Bioengineering Division appreciates the
opportunity to present its views to the Subcommittee on Labor, Health
and Human Services and Education.
______
Prepared Statement of the National Coalition for Cancer Research
On behalf of the 26 organizations which comprise the NCCR and
consist of 80,000 cancer researchers, nurses, physicians, and health
care workers; tens of thousands of cancer survivors and their families;
40,000 children with cancer and their families; 90 cancer hospitals and
cancer centers across the country; and more than 2 million volunteers.
It is on their behalf that I submit this testimony in support of the
National Institutes of Health (NIH), the National Cancer Institute
(NCI), and the Centers for Disease Control and Prevention.
Indeed, the harvest of the past investment of the American people
and Congress in supporting biomedical research is now being realized as
we are bringing on line powerful new tools that are delivering more
precise and rapid information that is already enhancing our
understanding and control of cancer. As just one example, I will focus
here on diet and the prevention of cancer to illustrate one facet of
this exciting advancement.
We have all known that eating more fresh vegetables and fruits are
good for us. For example, eating broccoli appears to be beneficial in
lowering the risk of cancer. A few years ago, a group at Johns Hopkins
isolated and identified the active sulfur compound from broccoli called
sulforaphane that when administered to animals prevented cancer from
developing when they were subjected to carcinogens. Most recently, Dr.
James Brooks and Dr. Pat Brown at Stanford University have illuminated
the mechanisms through which this compound might prevent cancer. When
cells were administered this sulforaphane, they turn on a battery of
genes that increase the cell's defense system that protects DNA from
damage. Conversely, sulforaphane turns off a set of enzymes that tend
to activate the carcinogens to a more DNA damaging form. This double
barrel effect of sulforaphane of both enhancing the ``good guys,''
while eliminating the ``bad guys'' in the carcinogenic mechanisms, is
at the heart of how sulforaphane might protect us from cancer.
This new DNA chip assay allows us to test many other similar
compounds and select the ones that would be most beneficial. This study
was made possible by another application of this new DNA chip
technology of which Dr. Klausner spoke to you in his testimony on
February 15. He reported how this technology was used to accurately
identify two different forms of what appeared to be similar cancers
that had responded differently to the same therapy. Therefore, the DNA
chips are not only being used to identify specific types of cancers and
how they might respond to different drugs, but are also being used to
study how factors in our diet might lower the risk of cancer.
For a long time, we have known that people living in China and
Japan have one-tenth the rate of breast and prostate cancer in
comparison to the United States. However, when the people from Asia
migrate to this country, their breast and prostate cancer rates
increase dramatically toward that which we experience here within the
United States population. What is it in the diets and environments that
brings this dramatic change about? Is the increased rate due to a loss
of a protective factor or the addition of a detrimental factor such as
a carcinogen? We have always suspected that there are many things in
our diet that might alter our cancer risks, and through the use of
these new molecular techniques, it will be possible to hunt these
agents out in a more systematic and rapid form. This means that much of
the initial testing can take place in cell systems using these DNA
chips and then extending the information to a more definitive study in
animals and then in clinical trials in humans. More is coming from the
new DNA technology, and this is only the first steps in a major
revolution in how we study cancer that resulted from your previous
investments, and it is now applicable to many diseases.
Another exciting area of research is on human pluripotent stem
cells. A new, emerging theory is that cancer is a stem cell disease.
The potential applications for stem cell research could have an
incredible impact on improving cancer treatment and prevention. The
research in this area is just emerging, and it would be a tragedy to
restrict. The NCCR urges Congress to permit the National Institutes of
Health (NIH) to fund and provide oversight for research on human
pluripotent stem cells and strongly opposes any attempts to ban this
very promising area of research. The NIH guidelines, which the NCCR
supports, create a federal regulatory framework for appropriate
applications and derivations of stem cells, require that stem cell
research is accountable to federal oversight and federal reporting
mechanisms, and ensure that stem cell research is pursued in an ethical
and responsible manner under public scrutiny.
There are dozens of other discoveries and exciting possibilities as
delineated in the NCI Bypass Budget Report and elsewhere that need to
be funded. We know that the control of cancer will only come through
research. The bad news is that we are not taking advantage of these
opportunities in an appropriate manner. The question that always comes
up is, ``Are we paying for bad research.'' It is important to realize
that when President Richard Nixon declared ``war on cancer'' we were
funding at 40 percent of the approved grants, and today we have dropped
down to 32 percent of the approved grants. There is little doubt that
if we now extended this up to 50 percent of the approved grants that we
would have a much better chance of finding discoveries at a more rapid
rate. No one knows where the next major discovery will come from, and
history has shown that many of the experts have often guessed wrong on
this matter. It would seem apparent that funding more approved projects
would increase the chances.
This increase in funding is not a waste in comparison to the cost
to the nation--over $107 million and half a million lives annually--and
the need to stop the devastation and carnage of cancer as quickly as
possible. I think we need to bet on more horses in the research race.
We all might be surprised at which research will win, but one will win
as it did for Lance Armstrong in his fight against cancer so he could
finally reenter and win the grueling Tour De France bicycle race. I am
confident that increasing our bets to funding the top 50 percent of the
approved grants will prove to be a good bet for the American people. To
do this, we would have to extend the budget to $4.1 billion for the
National Cancer Institute, the level recommended in the fiscal year
2001 Bypass Budget.
More funding for young physician scientists is also of critical
importance, because the goose that lays the golden eggs is now dying of
malnutrition. The work to which I just referred, on diet studies, of
Dr. James Brooks at Stanford as well as other important discoveries in
this area by Dr. William G. Nelson at Johns Hopkins are the results of
a young surgeon and a young medical oncologist having the opportunity
to carry out laboratory based research on cancer while still practicing
as leading physicians. They are some of the most valuable warriors in
our fight against cancer. Unfortunately, there has been a dramatic drop
in the number of these young physicians entering research, and this is
witnessed by the M.D. postdoctoral training funded by the National
Institutes of Health (51 percent decrease in six years) and in those
trainees funded by the Howard Hughes Medical Institute (57 percent
decrease in two years). These numbers are documented in a study
appearing in Science (Vol. 283, Page 131, 1999) by Dr. Leon Rosenberg.
These young physician scientist are under intense pressure as funds
have moved away from our non-profit medical institutions and over to
become the profits of the insurance companies. The insurance companies
do not invest in the training of these young scientists and neither do
they fund their research. At prior times, the non-profit medical
schools used funds that they received for medical care to support these
young physician scientist. All that has happened is that the funds have
now shifted from one pocket to the other, and the support for the
development of physician research has evaporated. The insurance
companies may be the only major industry that does not return any
appreciable percent of their profits to support research and
development and to protect their customer, the patient, in the future.
This shift in research funding is a tragedy that is choking the
goose that lays the golden egg of research discovery for our people. It
is urgent for Congress to act to support the National Cancer Institute
and the NIH in these dire times and to help stop this hemorrhaging of
our major medical training centers that is choking our young physician
scientist who are forced away from the laboratories and research to
desperately try to fill beds to compete for the decreasing care dollar
distributed from the insurance companies.
Insurance companies are also slowing the pace of research by
denying payment for and, therefore, patient access to clinical trials.
Investigational therapy administered under the aegis of a fully
approved clinical trial is often the best therapy available to many
patients. It is important that patients not be denied access to
clinical trials. The knowledge gained through these studies is
absolutely essential to achieve progress in cancer care. Both patients
and research suffer when health insurers will not reimburse for routine
patient care costs in clinical trials. This is compromising our
capacity to translate research from the laboratory bench to the
bedside. The NCCR supports legislative efforts to ensure third-party
payer's coverage of patient-care costs in clinical trials.
In my 40 years in research at Johns Hopkins, I have never seen such
a dramatic change as that which has occurred in the past few years, and
it certainly is not for the good of the patient nor for the future
generations. America deserves better. I know these are difficult and
sensitive issues, but I hope you can help lead us into an exciting
future. Increasing NIH and NCI support would certainly make a
tremendous difference, and it is most needed.
I am also here to assure you that cancer researchers are committed
to upholding the integrity of the clinical trial process, so that
patient safety and confidentiality are of the utmost importance. There
are inherent risks to being a cancer patient, as there are to receiving
anesthesia or any drugs. The critical points are to ensure patient
safety through close patient evaluation and informed decision-making,
which are hallmarks of clinical research. Informed decision-making is
enabled by explaining all potential risks and benefits to patients.
This process is an essential component to clinical trials, so that
patients are fully aware of complications that could occur and can
weigh the risks and benefits in order to determine whether or not to
participate.
An oversight structure, comprised of federal guidelines and
oversight as well as local oversight through institutional review
boards (IRBs) and data safety monitoring boards (DSMBs), closely tracks
research protocol activities to safeguard patient care in research.
Further, investigators and protocol nurses carefully monitor the
progress and safety of patients participating in clinical trials. In
conclusion, clinical trials provide excellent care for patients, are a
necessary and important step in research, are very closely monitored,
and serve as the lynchpin between research and accepted medical
practice for making advancements in the war against cancer.
The NCCR thanks you for providing this year's 15 percent increase
to NIH as the second installment to double the budget of the NIH over
five years. In terms of funding for fiscal year 2001, we are requesting
the third 15 percent increase for NIH, $4.1 billion for the NCI, and
$622 million for cancer control efforts and the CDC. This third
increase to NIH will bring us within 2 years of doubling the NIH
budget.
While amazing progress has been achieved in cancer treatment,
cancer remains the second leading cause of death in America. Let me
share with you a few facts which indicate the wide-reaching scope and
magnitude of cancer. One in two males and one in three females will
develop cancer of the course of a lifetime. Look to your left and look
to your right. The odds are that one of these individuals will be
diagnosed with cancer. One in four Americans will die form cancer. Now,
look to your left, look to your right, and look at me. The odds are
that one of us will die from cancer. Today alone, more than 3,000
people will be diagnosed with cancer, and over 1,500 will die from
cancer. Over the course of this year, over 1.2 million Americans will
be diagnosed with cancer and over half a million will die from cancer.
Too many people live with cancer, Mr. Chairman, and too many people die
from cancer. We have a moral obligation to aggressively pursue cancer
research and turn cancer from a too-often terminal disease into a
treatable, preventable disease.
It is important that we understand the magnitude of cancer
statistics both now and in the future. While cancer rates--the number
of people per thousand in the population who develop cancer in a given
year--have dipped slightly by 2.6 percent between 1991 and 1995, cancer
incidence, the new cases of cancer reported each year, is expected to
increase hugely over the next decades. As the Baby Boom Generation
ages, the number of Americans over age 65 will double to 69.4 million
in 30 years, and the number of Americans over age 85 will quadruple.
Currently, 64 percent of cancer occurs in patients over 65, the
Medicare population. By 2010 cancer incidence is expected to increase
29 percent and mortality 25 percent with annual costs exceeding $200
billion. The Medicare program is already facing serious problems, but
it will be utterly overwhelmed and crippled if cancer prevention and
treatment options do not improve significantly over the next thirty
years. It is imperative, thus, to mount an aggressive cancer research
front immediately.
Let me summarize for you what is needed to mount an aggressive and
successful, federal campaign against cancer that can fully exploit the
promising research opportunities that abound and then apply that
knowledge to improve cancer prevention, detection, and treatment at a
time when the incidence of cancer is projected to increase
dramatically. We need a 15 percent increase in the NIH budget and $4.1
billion for the National Cancer Institute. These increases will enable
high-quality and innovative research, much needed support and training
for young investigators, new equipment for researchers and
institutions, and the necessary infrastructure to support cancer
research in our increasingly technologically sophisticated age. We also
need to fully support the important cancer related programs at the CDC,
such as the cancer registries, breast and cervical cancer detection
programs, and the Environmental Health lab among others. We recommend
that the Committee provide $622 million for cancer control efforts at
the CDC. The combined efforts of and adequate funding for NIH, NCI, and
CDC are integral to understand, prevent, diagnose, treat, and
ultimately eradicate cancer. I wish to thank you for allowing me to
present this to you for your consideration.
______
Prepared Statement of the Children's Heart Foundation
Mr. Chairman and Distinguished Subcommittee Members: On behalf of
The Children's Heart Foundation and all who are suffering from
congenital heart defects we enter this testimony for consideration at
the fiscal year 2001 budget hearings.
According to the NIH Guide (Gene Nutrient Interactions in the
pathogeneses of congenital heart defects), September 1994, 42 percent
of all birth defects are caused by congenital heart defects. Eight
percent of all deaths during the first year of life are caused by this
condition, and of the 30,000 babies born each year with this anomaly,
2,900 of them will die before their first birthday. Thirty six hundred
children under the age of fifteen die annually from congenital
cardiovascular malformations (CCVM) or congenital heart defects.
In addition to the incredible impact on families, the social costs
are great as well. Many children who survive infancy are forced into a
life of dependency on medications, medical procedures, and repeated
open-heart surgeries. In 1992 nearly $500 million was spent to pay for
44,000 hospitalized children who were under fifteen years old.
Because so few of these children live long enough to have children
of their own, it has been difficult to carry out genetic studies of
CCVM. However researchers have now come to the conclusion that most
CCVM occurrences are caused by genetic defects. According to
information provided by the NHL&BI, the direct cause for at least eight
different structural heart defects may be genetic.
While we at The Children's Heart Foundation appreciate the genetic
studies that have been ongoing at the NIH, we also realize that
clinical studies on procedures and methods of treatment are vital to
the future of patients suffering with congenital heart defects. We wish
to encourage the committee to support more clinical projects in
congenital heart research. It is our understanding that at present the
budget for congenital heart research at the NHL&BI is fifty million
dollars.
We ask that the members of this committee grant fifty million
additional dollars to the NHL&BI with directives to increase clinical
and molecular research concerning congenital heart defects. The
increase will bring the budget to 100 million dollars, but in a budget
of, what we understand to be 15 billion dollars this is a small
increase to support research in America's number one birth defect.
In the next few pages we will present the stories of some of the
families who have lived with these life-threatening conditions. One of
these families has lost the battle while others still live with the
daily difficulties that accompany their illness. Please accept these
testimonies and the requests to testify before this committee under the
auspices of The Children's Heart Foundation.
Individuals and grassroots efforts can only do so much. Congress
must take on this effort and increase appropriations. So again, we
implore this committee to grant an increase of fifty million dollars to
the fiscal year 2001 budget earmarked to the NHL&BI for congenital
heart defects research. We thank you for your attention to our
requests.
______
prepared statement of jessica cowin
Mr. Chairman, members of the committee and all who hear this
testimony. My name is Jessica Cowin and I am 16 years old. I am
requesting to be slotted to testify before the appropriations
subcommittee.
I have had five heart surgeries since I was 4 days old because I
was born with a hypo plastic left heart. A hypo plastic left heart is a
heart that has no left side, in other words I had no pump. At 4 days
and 18 months the doctors performed closed heart surgeries on me. At 5
years and 13 years, I had open-heart surgeries. All of these surgeries
worked, for a while, but my heart began to fail in the last two years.
The doctors and my parents agreed that I needed a heart transplant. It
was very scary to think that the doctors were going to put someone
else's heart inside of me, but if I wanted to live longer that's what I
had to do.
On September 25, 1999, my mother got a phone call from the
Children's Memorial Hospital in Chicago (where I have had all of my
surgeries), saying that they had a heart for me. It has been two months
since my transplant and even though I am on a lot of medication I
already feel better. Before the transplant I had no energy and got sick
more often than other children. It also took me longer to get better. I
have also missed a lot of school in the past three years and I missed
my friends, too.
This has been very stressful for my family because everyone worries
a lot about me. I still have to go to a lot of doctors, physical
therapy, counseling and cardiac rehabilitation. I know my mom worries a
lot about the medical bills even though she tries not to show it.
Without the research for congenital heart defects, I would not be
here today. I was born in 1983 at Children's Memorial Hospital. At that
time they were not even doing heart transplants there. They started
doing transplants in 1988, when I was 5 years old. I have personally
benefited from the research of all of my five surgeries.
My mom tells me that there are still babies born with heart
problems that do not live and that I am really lucky that I have such
good doctors and that they knew what to do for me. I agree with her.
Please provide more federal funding for congenital heart research to
the National Institute of Health.
______
prepared statement of andrea piwowar
My name is Andrea Piwowar. Twenty-three years ago, I was born with
several congenital heart defects. I was diagnosed with tricuspid
atresia with transposition of the great arteries and a large
ventricular septal defect associated with pulmonary hypertension and an
absent pulmonary valve.
When I was three months old, I had a banding of the pulmonary
artery. In January of 1982, I had a modified Fontan, a surgical
procedure which makes it possible for blood to enter the lungs without
being pumped in by the right ventricle. This is achieved by connecting
the pulmonary artery directly to the right atrium. In my situation,
since I had transposition of the great arteries and a ventricular
septal defect along with tricuspid atresia, the underlying need for the
Fontan procedure, the surgeon corrected the transposition and closed
the hole between the two atria.
Seven months following the modified Fontan, I had a stroke. In
December of the same year, I had yet another stroke. It is my
understanding that it was thought that clots were forming in the
pulmonary stump; therefore, after the second stroke, I was operated on
again and the pulmonary stump was removed. The doctors could not find
where the clots came from. Even to this day, there is no explanation of
the strokes. After that operation, I was put on Coumadin and Lanoxin.
As a result of the strokes, which occurred after my corrective
heart operations, I have both orthopedic and speech impairments and
require the use of an electric wheelchair for mobility purposes.
Throughout my childhood, my parents fought for the appropriate
accommodations to be made in the school systems and for my right to be
in classes with able-bodied children. I felt like it was necessary for
me to work harder on class assignments just so I could keep up with the
class. I also felt that I had to prove myself to my teachers.
I am now an Indiana University graduate and am currently looking
for a job. I have had a couple of interviews and have spoken with
employers and recruiters over the telephone. At times, I feel as if my
impairments make it difficult for me to make a good first impression
with potential employers. I have been hung up on while speaking with
recruiters and employers have postponed and cancelled interviews with
me.
Like other patients who have had the Fontan operation, I am
beginning to see some of its side effects. Within two years, I have had
atrial fibrillation three times, each time requiring a cardio version
to get back into normal rhythm. I also have an enlarged atrium which is
causing my blood return to become sluggish.
My first bout with atrial fibrillation occurred during the week of
college midterms. I thought it might have been something that I had
brought on myself, because I had been working on several projects at
one time and staying up late to study, but I hadn't done anything
differently than I did during the previous semester. It wasn't until I
was in the hospital that I found out that atrial fibrillation was a
side effect from the Fontan procedure.
No one had informed me of any possible side effects of the Fontan.
Only by speaking with my cardiologist and reading personal experiences
of other Fontan patients I am beginning to understand more about the
side effects; however, I have yet to understand why some people with
congenital heart defects have strokes while others do not. As I
mentioned earlier, no one can explain why I had two strokes after the
Modified Fontan operation.
Several years ago, I wrote a letter to Dr. Thilenius, the
cardiologist who saw me before and after the modified Fontan procedure
was performed, inquiring about Hypo plastic Left Heart Syndrome. I
received a response that explained what Hypo plastic Left Heart
Syndrome was and the surgical procedures that could be performed,
depending on the severity of this disease. I was also given an
explanation of my congenital heart defects and the surgical procedure
that were performed to correct them. I was informed that strokes rarely
occur after a Fontan procedure, so rarely in fact, that it is not even
mentioned as a complication, but yet they still occur and no one seems
to know why.
So, I ask you, the distinguished members of the subcommittee, to
increase appropriations to the National Heart Lung and Blood Institute
to support clinical studies in the area of congenital heart research.
As more congenital heart research is performed, researchers may
discover why some people with congenital heart disease are more prone
to having a stroke than others and find a way to prevent them from
occurring.
I would like to submit my request to be given the opportunity to
testify before you, the distinguished members of the subcommittee, on
the issue of allocating increased funds to the National Institute of
Health for congenital heart research.
Thank you for your time.
______
prepared statement of megan van pelt
My name is Megan Van Pelt and I am the mother of a child born with
a congenital heart defect. Congenital heart defects have been a part of
my life since I was a child. My Cousin was born with a very severe
congenital heart defect and underwent many open-heart surgeries. Being
a child I could have never understood the magnitude or impact on the
family during this time. Doctors told my aunt that he would not live
past the age of nine. By the grace of god and congenital heart research
twenty-nine years later my cousin is still alive and functioning as a
normal healthy adult. Who could know that twenty-seven years later, I
myself would deal with the issue of congenital heart defects. In the
summer of 1997 my husband and I were anxiously awaiting the arrival of
our first child. During my routine twenty-four week check up I was
excited to finally see our baby in an ultrasound. As the ultrasound
progressed the technician informed me that she needed to get the
obstetrician to come in and look at the baby's heart. After the doctor
reviewed the tape, he informed me that our unborn child had a complex
congenital heart defect. For my husband and me the next three months
were a blur of cardiology visits and Internet research. On October 10,
1997 my amazing son, John ``Jack'' Ryan Van Pelt, came into our lives,
changing us forever. Nothing could have prepared me for the next four
months. Jack was born a navy blue color which according to the doctors
was normal because of the lack of oxygen his body was getting. Jack
weighed 4.5 pounds at birth. He was immediately transported to
Children's Hospital in Chicago. I have never felt so helpless.
A heart catheterization which was done shortly after Jack arrived
at Children's Hospital, confirmed the initial diagnosis of
transposition of the great vessels as well as three holes in his heart.
This meant that Jack's heart had developed backwards and all his blood
was flowing in the wrong direction. Because of Jack's size the Cardio-
Thorasic team did not feel that he was strong enough or big enough to
survive the complicated surgery that he needed. We spent the next two
months in the Neonatal Intensive Care unit, waiting. Because of his
heart Jack experienced liver and kidney failure. Everyday was a hurdle
for Jack and many days were touch and go. I thanked God for everyday I
had with him.
Finally on December 4th the surgeons felt Jack's condition was
deteriorating and the surgery could no longer wait. The surgeons
explained at length the surgery that Jack would undergo. The procedure
was relatively new and if successful Jack would not need to undergo
future surgeries. I will never be able to verbalize how it felt to sign
my son's life over to this team of doctors. The actual surgery took ten
hours. When Jack came out of surgery everyone warned us he would look
horrible, I am happy to say, they were all wrong. My husband and I
could not believe how pink he now looked. His body was finally
receiving oxygen. The doctors warned us that the next 48 hours would be
the most critical. Jack came through with flying colors. He had fought
for his life and won. My son was a survivor.
Through those three months I could not believe the amount of people
I became close to who had children surviving with congenital hearts
defects and dying from congenital heart defects. This is the number one
birth defect that children are born with, why don't most parents know
this? Why isn't there better education? But most importantly why isn't
there more research? There are children that I met who will undergo
open-heart surgery every three years as their hearts grow.
Unfortunately the funding for projects is not there to help researchers
find ways to fix defects the first time so it will be the only time
these children are forced to undergo additional lifesaving procedures.
I am happy to say that Jack is doing very well at the age of two.
We visit the cardiologist once a year. With every visit I hold my
breath afraid that he will need another surgery. Should that day come
we will take it in stride. The most terrifying part of having one child
with a congenital heart defect becomes the fact that every child you
have following has an even higher chance of being born with a
congenital heart defect. One out of every 115 babies is born with a
congenital heart defect in the U.S. each year. There are many worthy
causes and issues today, but there needs to be a greater awareness of
this, our number one birth defect. Because of our experience it has
been extremely important to my husband and I to give back. We have
become involved with the Children's Heart Foundation, which raises
money for research in congenital heart defects. Many of our recipients
have gone on to receive funding from the NIH for pediatric congenital
heart research. When it comes right down to it, the funding that is
needed isn't there. The American Heart Association gives less than 1
percent of their funding to research of congenital heart defects.
I ask you to take the time to visit a cardiac wing in a pediatric
hospital. There is a great chance that your family, friends, or
associates have been or will be affected by a congenital heart defect.
My family is reminded of it daily my cousin whom I spoke of earlier and
his wife are seven months pregnant. Sadly they have just found out
through ultrasound that their child will need to have open-heart
surgery. I ask you to sincerely consider dedicating more money for the
research of pediatric congenital heart research. Help us to educate the
public and find the answers to the number one birth defect. Thank you
for your time and consideration. We have an opportunity as the leading
healthcare nation in the world to find cures and new surgical
procedures to help these brave young fighters and I encourage you to
support us in the fight.
Thank you for your attention.
______
prepared statement of teresa taylor
Mr. Chairman; and Members of the Committee. I am requesting to be
slotted to testify before the appropriation sub-committee and I am
honored to give my personal testimony.
My name is Teresa Taylor from Skokie, Illinois in the county of
Cook, the 21st Congressional District of Illinois in the United States
of America. I would like to address this committee on behalf of all the
children born with congenital heart disease, those surviving, and in
honor of those that have lost their lives including my son, Sam. It is
with a personal story and a family history that I testify.
I want to go down on record that my son Sam and countless others
that have died prematurely not forgotten but remembered. And to be a
constant reminder for the need for additional federal funding for
research on congenital heart defects.
My son Sam, was born in Chicago, Illinois April 1993. He was born
with hypo plastic left heart syndrome. In other words, his left side of
his heart was underdeveloped. The left side of the heart is the main
pumping chamber of the heart and pumps blood to the rest of the body.
The devastation over our son's condition has caused us great sorrow
and pain. We knew very little in 1993 of his disease. There was little
that we could do except listen to the Doctors' prognosis and go along
with the treatment they suggested. In 1993, the options for Sam were
immediate open-heart surgery, or wait for a heart transplant. We opted
to place Sam on a heart transplant list originally called the UNOS
(united network of organ sharing). We were told that Sam would probably
get a heart within the next 6-9 weeks. We did not receive a heart when
we had thought. The heart for Sam came when he was 5 months old. He
lived in the hospital his whole life on a ventilator. I would not call
this life support but assistance so that his heart and lungs would not
flood up with blood while he waited for a heart. Sam died 2 weeks after
transplantation. He died due to lung and hospital related infections.
Because Sam waited only two days short of the longest wait for an
infant heart doctors did not know what to expect of his out come. Today
doctors know that an infant and most likely any patient waiting for a
heart transplant cannot survive as long as Sam did on a ventilator.
Because of Sam, doctors know that it is critical to find better ways to
manage a patient waiting for a heart transplant and open-heart surgery.
Today at Children's Memorial Hospital in Chicago, doctors have
perfected open-heart surgery that would have been used on Sam instead
of transplantation (the procedure is called Norwood). Research helped
in this matter and patients like Sam helped them in their research. Sam
and other children paid with their lives to help doctors understand
congenital heart defects and find ways to better manage and treat their
condition.
I make a plea to this committee, let this show that research is
direly needed to prevent cases where the doctors only learned after the
child's death of appropriate treatment for a child with a congenital
heart defect.
My story does not end here. I had a brother who died from a
congenital heart defect called tetralogy of Fallot. Today, many are
living many more years thanks to research. These dedicated Doctors to
find ways to manage and treat children with congenital heart defect
such as tetralogy of Fallot. My family history of congenital heart
defects goes back at least three generations. All of those in my family
who died were boys. I would like my daughters to one day have children
of their own. I would hope that they will feel safe that if they have a
boy and he is born with congenital heart disease that they will not
have to grieve for the loss of their son but embrace his survival. It
is my personal dream to see my son in the face of my daughter's
children, happy and healthy.
I want this story to someday have a happy ending to parents across
the country because federal dollars were spent in providing research in
this area, we need as parents to take a stand and ask questions. Why
did this happen to my child, is there research being done in this area,
what is the treatment for these children, what is their long term
prognosis, will we learn something from this and can our children have
the future that they deserve so much?
I have heard countless stories subsequent to our son Sam's death.
Stories of survivors with the same condition Sam was born with. These
children are living today because of research in congenital heart
defects. I only wish today that my son had this chance for a life. I
can only wish to carry on a legacy in his name, to help other children
have a chance to live and enjoy life like other children. The more
money that can be generated toward research, the more children in the
future will live with a heart defect not die of it. I plead to this
committee to pleases allocate more federal dollars to the to the Heart,
Lung and Blood Institute, and to direct research funds on congenital
heart disease.
Thank you for your attention in this matter.
______
Prepared Statement of the Doris Day Animal League
The Doris Day Animal League is a non-profit, member supported
national animal advocacy organization located in Washington, D.C. On
behalf of our 295,000 members and supporters, we respectfully present
to the subcommittee our concerns relating to The Coulston Foundation of
New Mexico and continued federal funding of that facility.
The Coulston Foundation is a private animal research laboratory
based in Alamogordo, New Mexico. It reportedly owns more than 600
chimpanzees, 300 other primates, and an unknown number of other animals
who are kept at two facilities, one on civilian ground, the other on
Holloman Air Force Base.
The Coulston Foundation has the worst animal care record of any
research facility in the history of the Animal Welfare Act, and has
long been of concern to the animal protection community and many
Members of Congress. The laboratory has been investigated seven times
by the U.S. Department of Agriculture (USDA) for serious violations of
the Animal Welfare Act. While the seventh investigation is ongoing, the
previous six have led to formal charges against the lab.
In August 1999, The Coulston Foundation and USDA signed an
unprecedented settlement agreement pertaining to the most recent set of
charges. Under the settlement, The Coulston Foundation agreed to divest
300 of its chimpanzees by January 2002, allow external financial and
animal welfare monitors to inspect the facilities, and to ``cease and
desist'' from further violating the Animal Welfare Act. Yet at least
five chimpanzees have died at The Coulston Foundation since the
agreement was signed.
The case of Donna, a 36 year old chimpanzee is perhaps the most
shocking of these recent deaths. She died last November from severe
infection to the uterus, bowels and peritoneal cavity after carrying a
dead fetus in her womb for at least two weeks. Records indicate that
veterinary staff at The Coulston Foundation were aware of Donna's
condition, but failed to provide adequate care in a timely fashion.
In total, at least 14 chimpanzees and 4 other primates have died
negligent deaths at The Coulston Foundation since 1993. Three
chimpanzees died at the lab that year when the temperature in their
cage soared to 150 degrees. In 1994, four monkeys died at the
laboratory from water deprivation and resultant dehydration. In 1997, a
healthy 11 year old chimpanzee named Jello died after being improperly
anesthetized. In March of that year, another chimpanzee, Echo, died
when veterinary staff failed to stabilize her for shock before surgery.
In early 1998 a chimpanzee named Holly died during a drug testing
protocol. In June 1998, two more chimpanzees died during a protocol
involving the same drug tested on Holly. In May 1999, a chimpanzee who
was being used in an invasive spinal study died from negligent care.
Five others, including Donna, died at The Coulston Foundation in the
second half of 1999.
The USDA is not the only federal agency concerned with the
deteriorating situation at The Coulston Foundation. In fact, in
December 1999, the Food and Drug Administration placed a restriction on
The Coulston Foundation for 270 violations of Good Laboratory Practice
standards, and warned the lab that no protocols or data would be
accepted by the agency until the violations are corrected.
As a major funder of The Coulston Foundation, the National
Institutes of Health (NIH) has also shown concern over the laboratory's
record, and in February, 1999, it placed a restriction on funding to
the lab. According to the restriction, future funding would depend on
The Coulston Foundation's hiring of seven ``fully qualified''
veterinarians. However, it is our understanding that the laboratory has
only two full-time veterinarians to date.
The situation at The Coulston Foundation is quickly deteriorating.
Documents obtained from NIH under the Freedom of Information Act state
that ``Based on current cash flow of [The Coulston Foundation], it
appears unlikely that it can continue operating for much more than two
or three months longer''.
That document was dated April 29, 1999. Since that time, NIH has
granted at least $1.1 million in ``supplemental awards'' to the
laboratory. This continued funding appears to be in direct
contravention of NIH's own restriction and the Health Research
Extension Act of 1985, under which the Director of NIH must ``suspend
or revoke Public Health Service funds'' to any facility which has
failed to correct violations of the Animal Welfare Act.
It is time for a candid reassessment of the Federal Government's
involvement with The Coulston Foundation. The prospect of the
laboratory going bankrupt is very real, and the short- and long-term
ramifications for the welfare of hundreds of animals there are serious.
While my organization understands that NIH is not ultimately
responsible for the welfare of the animals at The Coulston Foundation,
it does bear some moral responsibility for the animals there, many of
which were bred for and used in NIH-funded research.
There is immense public concern for the welfare of the animals at
The Coulston Foundation, many of whom were previously owned by the Air
Force and are the survivors and descendants of America's space program.
There is also frustration over the financial aspect of the situation.
While The Coulston Foundation is seemingly incapable of complying with
the law, it has been the recipient of millions of federal dollars (at
least $27 million since 1993), and continues to receive taxpayers'
money through NIH.
The government must address the situation at The Coulston
Foundation and work to avert what could be a potentially disastrous
scenario. We, therefore, respectfully ask the government to take
emergency action and appropriate $5 million via fiscal year 2001
Appropriations for Labor, Health and Human Services, Education and
Related Agencies for the care of the 300 chimpanzees which The Coulston
Foundation is under federal order to divest. While the ownership and
care of the animals certainly ought to be transferred to another party,
the chimpanzees could feasibly remain on Holloman Air Force Base for
the time being.
As a long-term solution to the problems at The Coulston Foundation,
we urge Congress to pass the Chimpanzee Health Improvement, Maintenance
and Protection Act (H.R. 3514), which would create a network of
federally supported private sanctuaries to which chimpanzees no longer
needed in research could be retired.
The chimpanzees and other animals at The Coulston Foundation are
unable to advocate for themselves, and the laws which are supposed to
protect them are failing to do so. While it is The Coulston
Foundation's ultimate responsibility to provide for the animals in its
care, it seems incapable of doing so. The government has enabled the
situation to escalate by continuing to fund the breeding and use of
animals at the laboratory.
A new direction is desperately needed. We respectfully ask this
Congress to ensure that our own government does not perpetuate a
situation which is ultimately harmful to the very animals it is charged
with protecting, and instead takes action to remedy the deteriorating
situation at The Coulston Foundation. Thank you for your consideration.
______
Prepared Statement of the Federation of American Societies for
Experimental Biology
Mr. Chairman, Mr. Harkin, Members of the Subcommittee: The
Federation of American Societies for Experimental Biology, FASEB, is
the largest organization of life scientists in the United States.
Founded in 1912, FASEB is comprised of 20 societies with a combined
membership of more than 60,000 scientists. Each year, FASEB brings
together representatives of our member societies to review the
biomedical research programs at NIH and other federal agencies. After
considerable deliberation and debate, these scientists produced funding
recommendations for each agency examined. This year's proposals are
contained in a report released for this budget cycle.\1\
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\1\ Federation of American Societies for Experimental Biology.
2000. Federal Funding for Biomedical and Related Life Science Research
fiscal year 2001. http://www.faseb.org.
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First, we would like to thank both the chairman and ranking member
for their ardent support for the research programs at the National
Institutes of Health (NIH) and for their efforts over the past two
years toward doubling the NIH budget within five years. We also would
like to ask that both Mr. Specter and Mr. Harkin continue to work with
their colleagues to press forward with this vital national investment.
We urge them to provide NIH with a 15 percent increase for fiscal year
2001, making the third installment toward the bipartisan goal to double
the NIH budget. This additional funding is needed to sustain and
further increase the momentum within NIH programs that has been begun
through your hard work.
While FASEB believes there are many issues important to the
continued long-term success of the NIH and health research in this
nation, our statement will focus on our two highest priorities. First,
we need to fund more research projects, especially investigator-
initiated research projects, and second, we need to ensure a continued
supply of highly-talented science personnel to carry out that research.
Research that is conceived and initiated by individual scientists,
investigator-initiated research, has been the key to the nation's
extraordinary progress in science. The magic that NIH has produced over
its history has occurred by supporting creative scientists to do
excellent research in laboratories around the nation. We have required
them to compete for support, under scrutiny of their peers and
competitors, in the marketplace of ideas. The resulting scientific
innovation and progress produced by this mechanism is attested to by
the fact that since 1945, 57 of the 76 U.S. winners of the Nobel Prize
in Physiology or Medicine were supported by NIH before they won their
award, including the 1999 award-recipient, Dr. Gunter Blobel. The
competitive, peer-reviewed system has excellence at its core and should
remain the principal mechanism used by NIH to distribute research
support. NIH should support the work of more scientists in their
laboratories; this will be the key to increasing research productivity
of the system as a whole. This competitive system is, we truly believe,
the most efficient, cost-effective and productive way to carry out
biomedical research and to maximize the return we get from it.
Budget increases, therefore, should be used largely to support more
research grants and to fund them at the lengths and levels approved by
the peer-review process. In some study sections, where grant
applications are reviewed, my colleagues report that projects rated
among the top twenty to twenty five percent come back for re-review
when the NIH is unable to fund them. We need more resources to
eliminate the redundant and discouraging cycle of re-submission and re-
review. We need scientists doing research, not ``in the system'' of
review. There is no shortage of good ideas. Therefore:
--the central principle guiding dispersal of research funds by NIH
is--and should remain--competitive merit review by their peers;
and
--the first priority in allocating NIH budget increases should be to
support more grants for research initiated by individual
scientists and to fund proposals at the durations and levels
recommended by peer-review.
With a 5.6 percent increase in funding for fiscal year 2001, NIH
predicts that it will be able to fund 31,524 research project grants,
an increase of only 237 grants over the fiscal year 2000 estimate. We
recognize that several mitigating issues contribute to this situation.
One appears to be the prudent concern about making too many long-term
commitments without the assurance of continuity of growth in NIH
funding. That is, if too many grants are funded one year then many
fewer grants might be renewed the next year if growth does not
continue. There was also significant need to re-build base programs
that were unable to be fully developed by NIH in the past due to
financial restraints. Furthermore, an increasing number of scientific
questions today require interdisciplinary strategies. These strategies
tend to involve powerful new areas of science and involve complex new
technologies and, consequently, they are typically very expensive.
However, the inability to fund more grants illustrates the
limitations of the proposed 5.6 percent increase. The total number of
funded projects will rise only less than one percent, and the number of
new grants awarded will actually decrease. With the continued increase
in the NIH budget that we advocate here, it is now time to turn our
attention toward investigator-initiated projects and substantially
increase their numbers.
In summary, the best way to sustain the phenomenal productivity
flowing from laboratories across the country is through competitively
reviewed, investigator-initiated research projects. Further increasing
the number of investigator-initiated projects will accelerate our
efforts to prevent, treat and cure diseases affecting millions of
Americans and their families.
Hand in hand with the need for more research projects is the need
to invest in the training of more scientists. We need to inspire young
people to pursue careers in science. To attract a new generation of
highly talented individuals, we must present them with a vision of
opportunity to make a career in academic biomedical research with a
realistic chance for success. Funding new investigators brings new and
creative ideas into science and sets the stage for future progress. A
decrease in new grants sends a devastatingly negative message to the
young people of this nation.
The absolute number of proposals from first-time applicants has
declined as a percentage of total grant applications during the 1980s
and 1990s. This is an unfortunate loss to the science community, as
young investigators have frequently been the source of the novel
insights that have led to major scientific breakthroughs. We are
successful at ensuring that our young scientists have the appropriate
skills to succeed, but we must also make sure that they do not lose the
desire or lack the means to establish their own laboratories and
initiatives. Therefore we encourage NIH to continue developing and
implementing competitive funding mechanisms that provide salary support
and start-up funding to facilitate the transition of outstanding young
investigators from their post-doctoral training to independent
positions.
One indispensable group of researchers, physician-scientists, is
already facing a critical shortfall. Physician-scientists bring a
unique perspective to medical research and education. This group plays
an essential role in the cross-fertilization between medical research
and medical practice. Their contributions in laboratory and clinical
settings are central to the progress in the battle against disease. In
addition, they play an essential role in training tomorrow's physicians
in the practice of scientific medicine. To ensure the rapid and
effective translation of research knowledge into health care practice,
and to ensure that insights from medical practice reach the
laboratories, we need to have a strong cadre of physician-scientists
working in medical schools and teaching hospitals across the nation.
Concern over the relative decline in the numbers of physician-
scientists led FASEB to initiate a major review of issues related to
the education and career development of this important research
resource. Our study concluded that there is a real threat to the future
supply of physician-scientists. There has been a decline in the number
of new physicians choosing to pursue research careers. Concomitantly,
the current pool of physician-scientists is aging. We found that the
proportion under the age of 45 was at an all-time low. These findings
suggest that we may have lost our ability to recruit young, talented
physicians to careers involving research.
One plausible cause for this trend is that increasing medical
school debt compels newly trained physicians to enter clinical practice
in order to pay off their sizable loans. Other possible factors include
a dearth of physician-scientist role models in medical schools and
residency training programs, a decrease of emphasis on research and the
science underlying medicine in medical school curricula, as well as
perceptions that the research career is too daunting or prone to
failure. Furthermore, declining revenues in academic medical centers
(brought on by managed care and other external forces) have tended to
increase the clinical burdens placed on physician-scientists and have
adversely affected the attractiveness or feasibility of this career
path.
Combined M.D./Ph.D. programs such as the Medical Scientist Training
Program (MSTP) have been quite successful in producing physician-
scientists; however, these programs do not support many or most M.D./
Ph.D. candidates because funding for positions in these programs is so
limited. FASEB therefore recommends that you enhance the contribution
of this successful program by doubling its budget, thereby increasing
its capacity to recruit and train bright, young physician-scientists.
MSTP and other M.D./Ph.D. programs are designed for first-year
medical students who know they seek a career in medical research;
however, there are also insufficient training opportunities for medical
students and medical graduates who become interested in pursuing this
career path after their medical training begins. FASEB has proposed a
series of recommendations to correct this situation:
--a national program for debt forgiveness for physicians who receive
rigorous research training and pursue research careers;
--support for the training and mentoring of early career physician-
scientists through expansion of research training programs for
medical students, residents and physicians who have already
completed specialty training; and,
--elimination of the statutory salary caps on NIH awards to
extramural investigators so as to remove disincentives to
research careers in medical centers.
Our principal reason for submitting our perspective to the
subcommittee is to ask their continued support for doubling NIH funding
by fiscal year 2003. We need to fund more research projects and support
more researchers. Quantifiable results will take time to see from this
new investment. But as evidenced by the spectacular achievements
resulting from our past investment that are being realized in doctor's
offices and biotechnology companies today, the funds that we invest now
will yield amazing future results that will further revolutionize
medicine.
For instance, a recent NIH-sponsored breast cancer prevention trial
offers to make an enormous impact on public health, and the lives of
countless American women, by providing the first proven measure to
reduce the risk of breast cancer. In this trial, the drug tamoxifen,
was shown to reduce the incidence of breast cancer in women at high
risk for the disease. The underlying evidence that led the NIH
investigators to pose this particular question was grounded in studies
initiated decades ago. Specifically, tamoxifen was first developed more
than 20 years ago as a treatment for breast cancer, and the genetic
mapping efforts that culminated in the identification of two breast
cancer related genes, BRCA 1 and 2, were also initiated in the 1980s.
Today, scientists are continuing to look for other drugs that might
similarly reduce the risk of cancer and also reduce the side effects
associated with use of this drug in some women. Thus, the cycle
continues and the gains to be had are amplified. But such benefits take
time to accomplish.
Another example is the discovery that mutations of the RET proto-
oncogene cause medullary thyroid carcinoma; a cancer that is often
hereditary and is difficult to treat once it develops. This discovery
made it possible to identify the carriers of this mutated gene within
high-risk families with 100 percent certainty. The thyroid gland of
carriers of the mutated gene could then be removed in early childhood
before any tumors developed and metastasized. NIH-funded research
supported investigators at each stage of this work from the discovery
of this gene to the mapping of the genetic locus and the identification
of mutations. Nearly 15 years elapsed from the initiation of the
mapping to the identification of the causative gene. Today, the
discovery process stemming from this research continues with the
identification of other components in the RET system and the unexpected
recent recognition that mutations in some of these other components
cause Hirschsprung disease, which is the most common cause of
intestinal obstruction in childhood.
In conclusion, Mr. Chairman (and members of the subcommittee), the
public has expressed its support for increased funding for medical
research and leaders both in Congress and in the Administration have
supported the goal of doubling the NIH budget within five years.
Funding increases in the last two years have enabled NIH to sow the
seeds of discoveries that we will reap three to five years from now.
With increased support for young investigators and physician-
scientists, we will inspire and encourage researchers who will continue
to make these discoveries a decade from now.
______
Prepared Statement of the American College of Chest Physicians
I am Susan Pingleton, M.D., FCCP, President of the American College
of Chest Physicians, Professor of Medicine at the University of Kansas
Medical Center, Director of the Pulmonary and Critical Care Division at
the University of Kansas Medical Center, Medical Director of the
Medical ICU, Chair of the ICU Committee, and a member of the KU
Internal Medicine Foundation Board Trustees and the Graduate Medical
Education Committee.
Thank you for affording me the opportunity to submit this testimony
for the record on behalf of the American College of Chest Physicians
(``ACCP''). The ACCP is a professional medical specialty society of
more than 14,500 physicians, scientists, allied health professionals
and educators who specialize in diseases of the heart, lungs, and
circulatory system. Since it was established in 1935, the College has
been a leader in cardiopulmonary medicine. Its members are specialists
in pulmonology, cardiology, cardiovascular and cardiothoracic surgery
and critical care medicine. The College provides a unique opportunity
for these specialists to further their professional education and to
combine expertise from several disciplines in the study of heart and
lung disease.
The ACCP appreciates the opportunity to offer its views to this
important Committee on fiscal year 2001 appropriations for the National
Institutes of Health (``NIH'') and the Centers for Disease Control and
Prevention (``CDC''). The ACCP is proud of its historic role in working
with and supporting various institutes at NIH who in turn support and
encourage biomedical research of great importance to our patients and
the entire country.
The President's budget request for NIH of approximately $18.8
billion, while laudable, does not go far enough to prevent and combat
all of the health problems over which the NIH has responsibility. We
applaud this Committee's efforts to make fiscal year 2000 funding for
the National Institutes of Health a top priority, but we still need to
commit substantial resources to research and prevention of pulmonary
and cardiovascular disease. Therefore, the College urges you to
appropriate a 15 percent increase over fiscal year 2000 funding for the
overall NIH. We agree with such groups as the Ad Hoc Group for Medical
Research Funding and the American Heart Association that an increase of
this level is necessary to sustain the high standard of scientific
achievement embodied by the institutes. Thus, we recommend a fiscal
year 2001 appropriation of $20.6 billion for the NIH. We also support a
15 percent increase over fiscal year 2000 funding for NIH heart and
lung research specifically.
The College supports significant increases to the budgets of the
National Heart, Lung and Blood Institute (``NHLBI'') and the National
Institute of Allergy and Infectious Disease (``NIAID'') to levels that
will enable these fine institutes to continue their wide spectrum of
research, both basic and applied, for the prevention and treatment of
cardiovascular and lung disease. With respect to the NHLBI, the ACCP
recommends a fiscal year 2001 appropriation of $2.330 billion. This
level of funding will allow the NHLBI to expand many of its existing
programs and fund exciting new initiatives. The NHLBI is committed to
maximizing the use of new technologies that are quickly becoming
available and ensuring that standard health practices throughout the
country reflect a thorough utilization of the knowledge that
researchers and health professionals have acquired. This increase in
funding will allow the NHLBI to expand its programs for genomic
analysis in cardiovascular, lung, and blood diseases, in an effort to
more precisely identify the causes and appropriate treatments of
disease. NHLBI will be able to continue and advance a pilot program
that is testing new uses of MRI technology to diagnose heart attack
patients who may be candidates for thrombolytic therapy, a clot-
dissolving treatment that may be able to significantly limit damage
from heart attacks. This increase in funding will also enable NHLBI to
establish innovative new clinical research networks, and study the
underlying reasons for health disparities among various segments of the
population in order to reduce these disparities.
Combating asthma is a high priority for the College. We know it is
a priority for both the NHLBI and NIAID. The ACCP supports a fiscal
year 2001 appropriation of $935 million for NIAID, not including the
estimated allocation for AIDS. More than 50 million Americans suffer
from allergies and/or asthma, and these diseases are major causes of
illness and disability. The economic costs associated with asthma are
enormous. Asthma costs the U.S. about $7.5 billion annually. Between
the years 1980 and 1994, the prevalence of asthma in the U.S. rose 75
percent. The prevalence of pediatric asthma rose 160 percent during
these years. In addition, asthma morbidity and mortality rates have
been increasing in the United States over the last decade, with over
5,500 people dying in 1996 as a result of an asthma attack. These
increases have been concentrated disproportionately in children and
minorities. These increases are alarming to the ACCP. We therefore
strongly support the efforts of the NHLBI and NIAID in working to
establish control over this disease.
The need for continued funding of tuberculosis (``TB'') prevention
and treatment is painfully clear. TB is the eighth leading cause of
death worldwide. Two million people will die from TB this year. One out
of every three people in the world has latent TB, thus creating a huge
potential for transmission of the disease and development of active TB.
Multi-drug resistant TB, which is caused by incorrect or incomplete
treatment, is an increasing problem in this country and throughout the
world, with as many as 50 million individuals infected. Multi-drug
resistant TB kills more than half of those infected in the United
States and is usually fatal in the developing world. These statistics
underscore the necessity of continued funding for TB prevention and
treatment activities.
Given the ease with which TB is transmitted, however, the
statistics of reported cases do not reveal the whole story. Consider
these statistics: an infected person with a normal immune system has
approximately a 10 percent lifetime risk of developing active TB. If a
person is HIV co-infected, he or she has an 8 percent annual risk of
developing active TB. Therefore, if a person is infected with HIV and
TB, and lives five years from the time of the TB infection, there is a
40 percent chance that person will develop active TB with the risk it
will be spread to others. If that same person lives 12 years, it is a
virtual certainty that he or she will develop active TB. With the lives
of our children at stake, our Nation's future, now is not the time to
reduce funding for TB. A decrease in federal funding is likely to lead
to a surge in active TB cases, including deadly multi-drug resistant TB
cases. Tuberculosis is an immense economic drain on families and on
nations and is a significant cause of poverty. The ACCP, therefore,
urges this Committee to increase funding for TB prevention and
treatment activities. Through its federally-funded research, NIAID has
already determined the complete genomic sequence of two strains of the
TB bacterium. These exciting breakthroughs are crucial to NIAID's plans
to develop a TB vaccine, but these efforts cannot advance without
Congress's substantial financial support.
We urge the Congress to support basic and applied research to the
fullest capabilities. Without it, many of the crucial health benefits
produced by the NIH would not be possible. With respect to the NHLBI,
we continue to be impressed with the quality of leadership of its
Director, Dr. Claude Lenfant. Research sponsored by the NHLBI has led
to tremendous strides in combating cardiovascular and pulmonary
diseases as well as hematological disorders. We recognize the strains
that have been placed upon the federal budget in recent years.
Nonetheless, diseases of the heart and lungs continue to pose the most
serious threat to our Nation's health. The desirability of exercising
fiscal austerity should not cause us to lose sight of the significant
health and financial benefits of funding medical research. The recent
scientific achievements of the NIH, and in particular NHLBI, have
created promising opportunities for understanding disease and improving
medical care. In order to benefit from these efforts and create new
opportunities for advancement, Congress must increase its funding of
both existing and proposed research projects.
These scientific achievements hold a personal interest for me. I
was born with a serious heart defect that had to be corrected through
primitive cardiac surgery when I was a child. I had to be packed in ice
to slow down my heart rate. Today, bypass machines do this work,
leaving surgeons to concentrate on the heart itself. My heart stopped
during the operation, and the resulting nerve and muscle damage to my
legs required me to learn how to walk again. I was given a low
probability of surviving past my teenage years, yet here I am today,
partially due to scientific achievements.
These experiences led me to enter into the medical profession. They
also lead me now to support substantially increased funding for
clinical research. Indeed, we believe that NIH in general and NHLBI in
particular ought to devote greater resources to clinical research, the
primary focus of many of our members.
I am compelled to share with the Committee some very telling NIH
statistics about the prevalence of heart and lung disease.
Cardiovascular diseases afflict more than 60 million people.
Cardiovascular diseases account for nearly 1 out of every 2 deaths in
the U.S., and lung disease accounts for 1 out of every 7 deaths in the
U.S. In addition to the untold costs of human suffering, the economic
costs associated with diseases of the heart, blood vessels, lungs and
blood represent 25 percent of the total economic costs due to illness,
injury, and death in 1999. More than 30 million Americans suffer from a
chronic lung disease. Lung diseases alone cost the U.S. economy an
estimated $85 billion annually in direct medical expenditures. The most
telling statistic, however, is that heart disease continues to be the
number one cause of death in this country. Cerebrovascular disease
ranks third, and chronic obstructive pulmonary disease (COPD),
including asthma, ranks fourth. Thus, three of the top four leading
causes of death are diseases that NHLBI is charged with combating.
These numbers point to NIH's need for continued federal support for
its vital programs. The ACCP continues to do its part to support
research. Through our CHEST Foundation, many ACCP members voluntarily
donate their own funds every year to support young investigators. This
year, the CHEST Foundation will award more than 20 clinical research
grants to young investigators. We believe this is unique compared to
other medical societies. We are committed to improving the quality of
the lives of the most important people we represent--our patients. But
we cannot do it alone. NIH appropriation levels must be increased to
ensure that our progress toward that goal is not thwarted. The Federal
Government must not waiver in its strong commitment to biomedical
advances of the future that would yield tens of billions of dollars in
health care savings. Therefore, funding levels consistent with the
important goals and essential mandate of NIH must be achieved.
As first hand observers of hundreds of thousands of deaths each
year caused by tobacco usage, the members of the ACCP urge this
Committee to fully fund the tobacco control efforts of the NIH and
Centers for Disease Control and Prevention (``CDC''). Smoking is the
primary cause of preventable death and disability in America, causing
more than 400,000 deaths, and costing approximately $89 billion
annually in medical expenses alone. An estimated 48 million Americans
smoke cigarettes, and over time, about half will suffer death or
disability as a result of their addiction. Smoking diseases, such as
lung cancer, emphysema, and coronary artery disease, and other
cardiopulmonary diseases have become a major socioeconomic problem of
transcending importance. Treatment of these diseases will continue to
drain over $800 billion from the Medicare Trust Fund. There are over 40
diseases/conditions that are caused by or aggravated by the use of
tobacco. Lung cancer is the leading cause of cancer-related death in
our population. Yet, the numbers of cancer diagnoses could be
drastically reduced if we could make serious inroads by curtailing the
use of tobacco--the number one cause of lung cancer. The NHLBI has made
important strides in identifying the deleterious health effects of
smoking, especially with respect to women. The ACCP, which has its own
Task Force on Women, Smoking, and Lung Cancer, supports the Institute's
continued efforts in this important area.
Increasing social, political, and legal pressure nationwide against
smoking has, overall, made a modest dent in reducing the prevalence in
smoking. As physicians, we confront on a daily basis debilitating
disease and death that result from inhalation of tobacco smoke. While
the ACCP has been active for more than 30 years in educating the public
about the harms of smoking, even our best efforts cannot match the
power of Congress to direct funds to combat lung cancer and other
deadly diseases that result from tobacco use.
As part of our commitment to improving the health of our patients,
the ACCP supports the work of the CDC in reducing death and chronic
morbidity caused by tobacco use. Adequate funding of the tobacco-
related research and state initiatives of the CDC are critical. We urge
Congress to increase funding for this tobacco prevention work at the
CDC to $130 million. CDC plays a leadership role in implementing and
coordinating state-based efforts and is focused on preventing
initiation among youth and promoting cessation. States that are
planning to commit tobacco settlement funds to tobacco prevention have
requested considerable technical assistance from CDC as they seek to
develop comprehensive and effective state programs. States such as
Florida, Massachusetts and Mississippi that already have comprehensive
programs in place relied considerably on CDC's expertise. Funds for
tobacco prevention at CDC are also used to maintain a comprehensive
database of smoking and health information and conduct laboratory work
regarding the dangers of nicotine and other toxic compounds in tobacco.
An appropriation of $130 million will significantly expand the capacity
of health and education departments to build and evaluate comprehensive
tobacco control programs, develop and promote health communication
campaigns for target audiences, and expand school health programs that
equip young people with the skills and knowledge to avoid tobacco
addiction.
Medical science has made giant strides in eliminating some diseases
that have afflicted populations in the United States and throughout the
world. The ACCP continues to seek new and improved treatments and
procedures to ameliorate the effects of diseases resulting from the
direct and indirect inhalation of tobacco smoke. We urge this Committee
to take action to curtail the national epidemic of tobacco-related
death and disease and to protect our Nation's children from tobacco
addiction and disease.
On behalf of the American College of Chest Physicians and our
millions of patients, I would like to thank you for affording us this
opportunity to submit our views for your consideration. The ACCP would
be happy to answer any questions you may have in the future.
______
Prepared Statement of the American Gastroenterological Association
summary of recommendations
The American Gastroenterological Association (``AGA'') urges
Congress to increase funding for medical research on digestive diseases
and disorders over fiscal year 2000 by 15 percent for the National
Institutes of Health (``NIH''), by 41 percent for the Centers for
Disease Control and Prevention (``CDC''), and by 47 percent for the
Agency for Healthcare Research and Quality (``AHRQ''). Within NIH, AGA
recommends at least a 15 percent increase for the National Institute of
Diabetes and Digestive and Kidney Diseases (``NIDDK''), the National
Cancer Institute (``NCI''), and the National Institute of Allergy and
Infectious Diseases (``NIAID'').
medical research recommendations
AGA appreciates the opportunity to present its views regarding
fiscal year 2001 appropriations for NIH, CDC, and AHRQ. AGA is the
nation's oldest, not-for-profit specialty medical society, consisting
of over 10,000 gastroenterologic physicians and scientists who are
involved in research, clinical practice, and education on disorders of
the digestive system. As the nation's largest and leading voice of the
gastrointestinal research community, AGA is uniquely qualified to
advise Congress on the current status of federally-supported digestive
disease research programs and the areas in need of further research.
Each year more than 62 million Americans are diagnosed with
digestive disorders.--Among the more common gastrointestinal disorders
are inflammatory bowel disease, irritable bowel disorders,
gastrointestinal cancers, and foodborne illness. In some of these
areas, medical research has brought us close to developing lifesaving
treatments and cures. Yet, in others, we still lack even a basic
understanding of the cause and transmission of the disease. This
testimony focuses on these serious health problems and makes
recommendations on how Congress should allocate this country's precious
medical research dollars. Specifically, AGA recommends that Congress
urge NIH to issue research grants in the following areas:
--Intestinal diseases caused by combinations of luminal (including
nutritional and bacterial), environmental, and genetic factors
with an emphasis on inflammatory bowel diseases and GI cancers;
--Modulation and understanding of epithelial injury and repair to
include: understanding of epithelial cell cycle regulation in
the GI tract; the effect of aging; and studies of epithelial
stem cells and their use for developing new approaches to
organogenesis;
--Cellular and molecular regulation of intestinal nutrient and
electrolyte transporters--to include effects of nutritional
factors, genetic abnormalities, aging, and disruption of
transport function to understand physiology and pathobiology;
and
--Development of physiologic tests to characterize the phenotypic
subgroups of functional gastrointestinal disorders, including
non-ulcer (functional) dyspepsia, functional constipation and
irritable bowel syndrome (motility).
The following discussion supports the need for research in the
aforementioned areas.
Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease)
It is estimated that one million Americans have inflammatory bowel
disease (``IBD'').--The two forms of IBD are Crohn's Disease and
Ulcerative Colitis. Crohn's Disease usually causes intermittent
inflammation deep within the intestinal wall of the small intestine
whereas Ulcerative Colitis causes continuous inflammation and sores in
the top layers of the lining of the large intestine. Although older and
younger people may also develop this disease, IBD usually begins
between the ages of 15 and 40 and persists throughout life with
remissions. IBD affects people in the prime and most productive years
of their lives and results in substantial morbidity and economic loss
to them and society. It is especially brutal in children who may suffer
developmental delays or stunted growth. People with IBD experience
abdominal pain, fever, bowel sores, intestinal bleeding, anorexia,
weight loss, fullness, diarrhea, constipation, and vomiting. In severe
cases, IBD can cause death. In addition to potentially disabling
gastrointestinal problems, people with this disease may also suffer
from arthritis, skin problems, inflammation of the eyes or mouth,
kidney stones, gallstones, or other diseases of the liver and biliary
system. Further, approximately five percent of people with ulcerative
colitis will develop colon cancer with the risk increasing based on the
duration and extent of involvement of the colon.
Studies on the cause of IBD are desperately needed in order to have
a better understanding of the disease and work towards more effective
management and treatment. Specifically, AGA recommends that NIDDK
support genomic research aimed at identifying abnormal genes in persons
with IBD and finding the causes of IBD.
Motility Disorders
It is estimated that up to thirty percent of all Americans may be
affected at some time during their lives by motility disorders.--
Irritable bowel syndrome (``IBS''), the most common motility disorder,
is especially troubling because a patient does not present with any
pathognomonic symptoms or laboratory findings of the disease, making
diagnosis and treatment extremely difficult. Instead, patients present
with abdominal pain, bloating, gas, diarrhea, and constipation. It is
believed to be caused by overly sensitive intestines that have muscle
spasms.
Further research is needed in this area due to the high prevalence
and the lack of a basic understanding of IBS, a factor which has made
drug manufacturers reluctant to fund research. If more federally funded
research was focused on IBS, it would stimulate more private-public
partnerships, and lead to advances in medical knowledge. As such, AGA
urges Congress to direct the NIDDK to focus additional resources on IBS
and to encourage the Office of Research on Women's Health to devote
more of its attention to these areas of research in light of the high
incidence of IBS among women. Specifically, AGA recommends that NIDDK
support research into the development of physiologic tests to
characterize the phenotypic subgroups of functional gastrointestinal
disorders, including non-ulcer (functional) dyspepsia, functional
constipation, and irritable bowel syndrome (motility).
Gastrointestinal Cancers
Approximately 226,600 new cases of gastrointestinal cancers will be
diagnosed this year.--Sadly, 129,800 Americans will die from these
cancers. The most common cancers involve the colon/rectum, stomach/
esophagus, and pancreas.
--Colorectal cancer is the second leading cause of cancer-related
deaths in the United States and ranks fourth as the most common
cancer.--Although risk factors, such as race (increased
prevalence and mortality for African Americans), influence the
development of this cancer, 70 percent to 80 percent of
colorectal cancer cases involve average-risk individuals. If
diagnosed early, this cancer is highly curable. However, many
people with colorectal cancer are asymptomatic until the later
stages of the disease and wait to seek professional advise
until this time. As such, research and early detection through
screening remains the key to preventing, treating, and curing
this disease. We applaud Congress for its major step forward in
preventing and curing this disease by providing Medicare
coverage for screening and declaring March ``National
Colorectal Cancer Awareness Month''. We encourage Congress to
continue this work and require coverage for screening for all
Americans. Further, we urge Congress to support additional
research on colorectal cancer. Finally, we commend NCI for its
work on the Progress Review Group (``PRG'') for colorectal
cancer.
--Pancreatic cancer will be diagnosed in 28,300 Americans in 2000
with 28,200 people projected to die from this disease.--It is a
highly lethal form of cancer with the lowest survival rate
among all major malignancies. Like other digestive cancers,
this cancer is frequently asymptomatic. African Americans have
a 50 percent higher incidence and mortality rate than
Caucasians. Further, age may increase the risk for this disease
because the average age at diagnosis is 70 and it rarely occurs
before 40. Diabetes mellitus has also been linked to the
development of this cancer. We appreciate NCI's recognition of
this growing problem and the need for research in this area
through its establishment of pancreatic cancer PRG.
--Of increased concern to AGA are esophageal and stomach cancers.
Lower esophageal and upper stomach cancers are the second most
common gastrointestinal cancers.--It is projected that 33,800
Americans will be diagnosed and 25,100 will die in 2000 from
these cancers. These cancers also often remain undetected
because they are asymptomatic or present with vague symptoms.
In fact, only 10 percent to 20 percent of patients with stomach
cancer are diagnosed at an early stage. Both are more common in
African Americans with stomach cancer also occurring more
frequently in Hispanics and Asian Americans. Of heightened
concern to AGA is Barrett's esophagus, a precursor to
esophageal cancer, and the relationship between Barrett's and
chronic gastroesophageal reflux disease (``GERD''). Five to ten
percent of people with Barrett's esophagus develop cancer of
the esophagus. We urge Congress to direct the NCI to fund a
Progress Review Group (``PRG'') on esophageal and stomach
cancers to further study these deadly diseases. AGA encourages
the NIDDK to support research into the modulation and
understanding of epithelial injury and repair to include the
understanding of epithelial cell cycle regulation in the
gastrointestinal tract and studies of epithelial stem cells and
their use for developing new approaches to organogenesis and
transplantation.
Foodborne Illness
Foodborne illness is estimated to cost annually $5 to $6 billion
dollars in direct medical costs and productivity losses.--Most
foodborne illnesses attack the gut causing gastrointestinal problems
which may lead to dehydration and shock, and if not treated, death from
vascular collapse and renal failure. Those populations at-risk for
severe repercussions from foodborne illness include those with
decreased immune systems, pregnant women and fetuses, young children,
elderly, and those with inadequate access to health care. We appreciate
NIDDK's efforts to further our understanding of this illness through
its RFA on foodborne illness research which was co-sponsored by AGA
through the American Digestive Health Foundation (``ADHF'') and the
National Cattlemen's Beef Association. AGA recommends that Congress
encourage the NIH, including NIDDK and NIAID, and others conducting
foodborne illness research like the United States Department of
Agriculture and the CDC to concentrate more intensively on research
into treatments for foodborne illness. AGA urges NIDDK and NIAID to
support research on (1) intestinal diseases caused by combination of
luminal (including bacterial), environmental, and genetic factors with
an emphasis on inflammatory bowel diseases, and (2) the reaction of the
gut to foodborne pathogens, including research on the pathogenesis of
the disease, the reasons for antibiotic resistance, the reaction of the
gut to infections, the development of animal models to test therapies,
and the invention of vaccines or substances that bind with the toxins
to prevent the illness.
Training of Physician-Scientists
While research has expanded our medical knowledge and enabled
providers to better prevent diseases, diagnose disorders, and treat
people, there is growing concern that the number of physician-
scientists (e.g., investigators who have medical degrees) is declining
and that this decline will negatively impact many key future research
endeavors. A recent study documenting this decline points to the
tremendous debt incurred by medical school graduates who have more
lucrative options outside of research as a primary cause. See Tamara R.
Zemlo et al., The Physician-Scientist: Career Issues and Challenges at
the Year 2000, 14 The FASEB Journal 221-230 (2000). Also influencing
this trend is a decline in mentorship due to a decrease in the number
of physician-scientist faculty in basic science departments and the
increased clinical responsibility currently assumed by such faculty
members. AGA views this problem as an immediate and serious threat to
the future of biomedical research generally, and gastrointestinal
research in particular. As such, AGA urges Congress to take the
following steps:
--Increase pre- and post-doctoral research training stipends;
--Raise the salary cap for individual grant recipients to the maximum
amount allowable under the Senior Biomedical Research Service;
and
--Enact the ``Clinical Research Enhancement Act of 1999'' (H.R. 1798,
S. 1813).
______
Prepared Statement of the National Depressive and Manic-Depressive
Association
The National Depressive and Manic-Depressive Association is pleased
to have this opportunity to submit written testimony in support of
fiscal year 2001 funding for mental health research supported by the
National Institutes of Health and the National Institute of Mental
Health.
With nearly 300 affiliated groups in nearly every major
metropolitan area, National DMDA is the nation's largest patient-
directed, illness-specific organization committed to advocating for
research toward the elimination of mood disorders; educating patients,
professionals and the public about the nature of depression and manic-
depression as treatable medical diseases; fostering self-help;
eliminating discrimination and stigma; and improving access to care.
National DMDA was founded in 1986 and is headquartered in Chicago,
Illinois. A distinguished Scientific Advisory Board of nearly 65
members reviews all materials published by National DMDA for medical
and scientific accuracy and provides critical and timely advice on
important research opportunities and treatment breakthroughs. This
Board includes the leading researchers and clinicians in the field of
mood disorders.
the impact of mood disorders
More than 20 million American adults suffer from unipolar or major
depression every year. An additional 2.3 million people suffer from
manic-depression or bipolar disorder. Women are more than twice as
likely as men to experience major depression. Two out of three people
with mood disorders do not get proper treatment because their symptoms
are not recognized, are misdiagnosed or, due to the stigma associated
with mental illness, their symptoms are blamed on personal weakness.
Depression is the leading cause of suicide in the United States. In
fact, the suicide rate is 50 percent higher than the homicide rate in
the United States.
According to a recent study by the World Health Organization (WHO),
the World Bank, and the Harvard School of Public Health, unipolar major
depression is the leading cause of disability in the world today and
bipolar disorder is the seventh-ranked cause of disability. The
economic cost of mood disorders in the United States was estimated in
1996 to be almost $44 billion per year in direct and indirect costs
including absenteesim, mortality and lost productivity. The fact that
mood disorders carry a higher burden of disease in our society than
cancer illustrates the need for more adequate funding in this area for
research. We can no longer continue to ignore the burden of mood
disorders for our society and must focus our research resources on
better understanding these illnesses, significantly improving
treatments, and seeking a cure.
progress in diagnosis, prevention and treatment
Depression and manic-depression are highly treatable medical
illnesses, if diagnosed and treated correctly. In fact, their treatment
success rates are higher than for other chronic illnesses. However, one
of the biggest obstacles to expanding access to services is the
historical stigma surrounding mental health treatment, exemplified by
arbitrary and unfair limits placed on access to mental health services
by private health insurance plans. Access to treatment due to financial
limitations is, for many patients, a huge barrier.
Increased public awareness and understanding of mood disorders
would contribute significantly to improved diagnoses and treatment
rates for these potentially fatal illnesses. Tragically, individuals
untreated or undertreated for major depression have a suicide rate in
excess of 15 percent. The rate for those with untreated or undertreated
bipolar disorder is over 20 percent.
National DMDA is encouraged by the heightened attention being paid
to mental illness as evidenced by last year's White House Conference on
Mental Illness and the recent Surgeon General's Report on Mental
Health. Getting people to talk openly and publicly about mental illness
is an important first step toward reducing the stigma. But there is
much left to be done.
As the Surgeon General's report notes, there is a link between
research yielding explanations of and effective treatments for mental
illnesses and reduction of this stigma. We know that science
destigmatizes. As more and more people come to understand that mood
disorders are medical illnesses, not character flaws, and that they are
treatable, we can make significant reductions in both the human and
economic costs of these illnesses.
Research supported by NIMH has already led to many discoveries
resulting in improved diagnostics, prevention, and treatments, which
has saved lives and billions of tax dollars. For example, more than
$145 billion has been saved since 1970 as a result of the development
of lithium treatment for bipolar illness--almost $6 billion per year. A
study supported by NIMH showed that intervention to prevent depression
in the workplace resulted in $1,314 per person in increased federal and
state taxes generated over a two and a half year period, with a cost of
only $286 per person. Finally, it has been shown that every $1 spent on
treatment of mood disorders yields between $3 and $9 in net economic
return on employment earnings.
NIMH-supported research has led to new and more effective
medications for both depression and manic-depression. We also have a
better understanding of mood disorders and are learning more about
their impact on cardiovascular disease, stroke and diabetes. The co-
morbidity of depression and alcohol and tobacco use is also becoming
clearer. Research indicates that treating addiction but not depression
leads to failure and relapse and vice versa.
genetics
Current research indicates that there is a genetic predisposition
to manic-depressive illness and major depression, involving multiple
genes. Understanding the genetic basis of mood disorders will lead to
vastly superior methods of prediction, diagnosis, treatment and
prevention. We support a continued investment in NIH to achieve the
completion of the human genome sequencing project and applaud the
accelerated timetable for completion. Mapping of the human genome will
be critical to uncovering the genetic factors involved in mental
illness and clarifying the phenotypes of major mental disorders. We are
pleased that NIMH has compiled a database of families with mental
illness for genetic analysis as the science and technology becomes
available in the near future. A high priority should also be the
epidemiology and clinical evaluation of individuals with manic-
depression and their family members. Of utmost importance as these
projects move forward is respect of the privacy of those individuals
involved, especially given the continued struggle to fight the stigma
of mental illness. Confidentiality is of critical importance in the
management of all medical records.
clinical research
National DMDA believes that the translation of research from the
laboratory to the bench in a rapid and efficient manner is of paramount
importance and is pleased to see the Surgeon General's report and NIH
leadership acknowledge the need for increased clinical research. The
expansion of NIMH's Translational Centers program, dedicated to rapidly
moving basic science from the lab into the clinical setting, is another
strong step toward getting new and improved treatments to patients more
quickly. Requiring third-party payors to support important patient care
costs associated with promising experimental therapeutics would further
facilitate completion of clinical evaluation at the earliest possible
moment.
National DMDA plays an important role in several large NIMH-
sponsored clinical trials. Our representatives are members of oversight
committees for trials studying the effectiveness of treatments for
bipolar disorder (STEP-BP), the study of treatments for adolescents
with depression (TADS), and the study treatment of individuals with
depression who do not benefit from standard initial treatments
(STAR*D). We are also on the advisory board of the trial studying the
efficacy of Hypericum perforatum (St. John's wort), a compound millions
of Americans take with very little scientific data available to show
efficacy or safety. National DMDA participates in the oversight of
these trials because of its belief that the priority of all clinical
trials must always be the safety of the patient.
We fully support NIMH plans to further expand clinical trials of
treatments for mental illnesses, including exploration of depression in
young children. We urge a significant increase in research of mood
disorders in child and adolescents with special emphasis on the
efficacy and safety of current treatments, the epidimology of these
illnesses and improved diagnostic tools.
mood disorders in children and adolescents
The issue of mood disorders in children and adolescents is of
particular concern to National DMDA. Up to 2.5 percent of children and
up to 8.3 percent of adolescents suffer from clinical depression, which
if left untreated is the predominant cause of suicide, the third
leading cause of death in males ages 15 to 24.
While mood disorders in children and adolescents is a critical area
of concern, virtually no research about this population exists. As the
Surgeon General's report points out, to be effective, diagnosis and
treatment of mental illness must take into consideration a variety of
characteristics including age. Further, identifying depression in
children as well as understanding its causes and how best to intervene
during childhood offers the best hope for preventing many cases of
adult mental illness.
National DMDA supports the aggressive research agenda NIMH is
pursuing in this area, including a study to examine the course and
outcome of bipolar disorder with onset in childhood and early
adolescence, and research examining underlying bioregulatory processes,
neurobehavioral system, adolescent pubertal development and their links
to major depressive disorder. We are particularly encouraged by NIMH
efforts to strengthen the field of children's mental health research by
creating new incentives for experienced investigators to move into
studies of mental illness in children.
We are pleased that NIMH will play a lead role in the Surgeon
General's upcoming report on youth violence and support the continued
coordination between NIMH and Centers for Disease Control (CDC) and
other agencies to research the relationship between mental illnesses--
including mood disorders--and suicide and other forms of violence.
bipolar disorder (manic depression)
The World Health Organization has identified bipolar disorder as
the seventh-ranked cause of disability in the world today. Nearly one
in 100 Americans suffers from manic depression yet research in this
area has been seriously underfunded. In fact, In 1998, NIMH spent only
$39 million on bipolar research and it is expected to spend just $46
million in fiscal year 1999. Congress must continue to increase its
investment in this important area of mental health research.
research opportunities
National DMDA urges NIMH to pursue genetic research aggressively in
collaboration with other NIH Institutes, academia, the private sector
and by continuing studies of individuals with manic depression and
their family members. Other factors to examine in relation to genetics
include building and refining knowledge of risk factors for mood
disorders, developing better predictors of risk, designing and piloting
new screening measures, advancing early-intervention strategies for
these risk factors, and studying the role stress and the environment
play.
Neuroscience advances bring us to the brink of tremendous
opportunities to understand underlying deficits in major mental
disorders. We know more about neurobiology today than ever before and
we must support, as a national priority, continued efforts to enable us
to more fully exploit our recent advances. Flexibility of connections
in the nervous system underlies many of the adaptive responses of the
individual to the environment--including response to psychological and
physical trauma and the more general processes underlying learning and
memory--and such changes in the neural function are central to most
mental disorders. The field is now poised to make deep inroads into the
understanding of these critical processes.
Other important opportunities include research to better
characterize subtypes of depression; to find treatments with fewer side
effects and understand the psychopharmacology of current
antidepressants; and studies to close the gap between what is known
about treating mood disorders and what is practiced, particularly in
managed care settings. These are just a few of the research areas where
great opportunities exist.
funding request
An aggressive research agenda requires sustained funding. While we
recognize the Subcommittee's budgetary constraints, National DMDA
supports the effort initiated in fiscal year 1999 to double the budget
for NIH and NIMH by fiscal year 2003. This will allow us to take full
advantage of the many exciting mental health research opportunities
that exist today. To continue the successes toward achieving this
important goal, we strongly support the fiscal year 2001 funding
recommendation of the Ad Hoc Group for Medical Research Funding of
$20.5 billion for NIH. National DMDA supports a corresponding increase
for NIMH.
Sustained, stable growth in funding for NIH is needed to build upon
past scientific achievements, address present medical needs, and
anticipate future health challenges. Dramatic fluctuations can be as
harmful to the research enterprise as inadequate growth.
We appreciate your past support and look forward to working with
you in the future to ensure a sustained commitment to mental health
research. Together we can provide the gateway to new discoveries that
will improve access to care and eliminate discrimination and the stigma
associated with depression and manic-depression.
______
Prepared Statement of the American Association of Colleges of Nursing
The American Association of Colleges of Nursing (AACN) appreciates
the opportunity to present this statement on funding recommendations
for nursing research and education programs within the jurisdiction of
the Subcommittee. AACN represents over 540 baccalaureate and graduate
nursing education programs in senior colleges and universities across
the United States.
We thank the Subcommittee members for providing fiscal year 2000
funding to the National Institute of Nursing Research (NINR) at its
full Professional Judgment Budget level. AACN also appreciates the
leadership of Chairman Specter and the Subcommittee over the years in
funding nursing and health professions education programs to benefit
the health and well being of the Nation. Our appreciation extends to
the Subcommittee's leadership regarding the Health Resources and
Services Administration's (HRSA) Health Profession Programs,
particularly the Nurse Education Act (NEA) (Public Health Service Act
Title VIII) and Scholarships for Disadvantaged Students (SDS) programs
(in PHSA Title VII).
national institute of nursing research
Mr. Chairman, we thank you and the Subcommittee for NINR's
significant funding increase for fiscal year 2000 at an adjusted level
of $89.522 million, an increase of $19.734 million or 28 percent more
than the fiscal year 1999 level. The entire nursing community is
grateful for this funding level, which brought the estimated success
rate for NINR research project grants for fiscal year 2000 to 24
percent, compared to the projected average of 31 percent for NIH
overall. This is an enormous improvement over fiscal year 1999 when
NINR's success rate was only 14 percent.
Unfortunately the excellent progress made by the Subcommittee last
year is threatened by the Administration's fiscal year 2001 request of
$92.524 million, an increase of only $3 million or 3.3 percent for
NINR. This is the lowest proposed increase of all NIH Institutes and
Centers. The fiscal year 2001 request would continue NINR's
disproportionately slow growth rate compared to NIH in general. Since
1986, NINR has received only $75.5 million, or 0.6 percent of the total
NIH growth of $12.3 billion. In fact, the entire fiscal year 2000 total
for NINR is less than the increase provided by the Subcommittee in
fiscal year 2000 for 10 NIH Institutes and Centers. Finally, the
Administration's proposed NINR funding level would plunge NINR's
projected research project grant success rate for fiscal year 2001 to
14 percent compared to the 26 percent success rate projected for NIH
overall. Clearly this would result in missing a significant amount of
important scientific opportunities.
AACN, supported by the Tri Council for Nursing and the 33 members
of the Coalition for Nursing Research Funding, urges funding the NINR
at $110 million, $17.476 million above the Administration's request. At
this funding level, NINR could conduct significant new research
recommended by its Professional Judgment Budget such as: research on
health disparities in ethnic groups, self management of chronic
illness, expanding end of life research to address pain, nausea, weight
loss and caregiver issues, and studying telehealth interventions in
rural/underserved populations.
NINR is the lead institute at NIH to coordinate research on end-of-
life care that is critically important to our aging population. End-of-
life care utilizes many of the skills of nursing such as management of
pain, handling of chronic conditions, and family counseling. As the
American population continues to age, the importance of this research
both to reduce morbidity and health system costs continues to grow.
While 13 percent of the current U.S. population is 65 years of age or
older, by the year 2030 this proportion is projected to be 20 percent.
The Subcommittee investment in NINR is well justified as nursing
research contributes extensively to wellness and health outcomes. The
NINR performs a wide span of clinical research, developing and testing
interventions to improve patient care, treat disease, manage chronic
conditions and address other concerns. There is growing evidence of
advances made possible through NINR research, but we will highlight
just five recent success stories. AACN believes that based on these and
numerous other examples, there is broad agreement that nursing research
is making a difference in health outcomes. For example, NINR research
has made a difference by identifying interventions to:
--Facilitate early hospital discharges of high risk elderly patients,
reducing the length of stays, the hospital re-admission rate
and Medicare costs;
--Reduce the rate of low birth weight babies among high risk women,
as well a reducing the rate of subsequent emergency room
admissions of the mothers and their babies;
--Estimate the (often fatal) improper insertion of feeding tubes with
the use of a low cost bedside chemical test;
--Reduce high blood pressure in young urban African-American men at
high risk for cardiovascular disease and reduce cholesterol
levels in minority children; and
--Avoid the need for nursing home care of elderly women by
controlling urinary incontinence.
the nurse education act
The Nurse Education Act (Public Health Service Act Title VIII)
helps schools of nursing and nursing students prepare for a changing
health care delivery system. Reauthorized in 1998, the NEA offers
flexibility through expanding specific program initiatives, including
Advanced Education Nurse Grants, Work Force Diversity Grants, Basic
Nurse Education and Practice Grants, and an education loan repayment
program to attract nurses to practice in shortage areas.
Advanced Education Nurse Grants to schools help educate advanced
practice primary care nurse practitioners and nurse midwives. The
program also provides grants to educate master's and doctoral students
as clinical nurse specialists, public health nurses, nurse
administrators, faculty (a major shortage exists), nurse anesthetists,
and non-primary care nurse practitioners and includes traineeships for
master's and doctoral students with a limit of 10 percent of
appropriations for doctoral traineeships. The growing number of
elderly, increasing number of individuals with chronic diseases, high
infant mortality rates, and rising number of uninsured and underserved
individuals all drive the demand for affordable, cost-effective health
care. This need is successfully met by nurses with advanced nursing
education.
The Work Diversity Grants program provides funds to increase
opportunities for nursing education for disadvantaged students
including underrepresented minorities by providing scholarships,
stipends, pre-entry preparation, and retention activities. In addition
to contributing to the preparation of a racially and ethnically diverse
nursing workforce, this program contributes to the basic preparation of
disadvantaged and minority nurses for leadership positions within
nursing and the health care community. The minority enrollment in
schools of nursing supported by this program is 46 percent compared to
the national average of 19 percent.
The Basic Nurse Education and Practice Grants can support nursing
centers as training and care delivery sites, increase undergraduate
enrollments (a nursing shortage looms), provide entry level training
for practice within underserved populations, managed care facilities,
to develop cultural competence and for other purposes. AACN recommends
$78 million for Title VIII Nurse Education Act programs in fiscal year
2001, $10.2 million or 15 percent more than requested by the
Administration.
scholarships for disadvantaged students (sds)
Scholarships for Disadvantaged Students (SDS) is a PHSA Title VII
program that provides funds to disadvantaged and minority health
professions students. Federal law directs 16 percent of the funds
appropriated to nursing students in the program-making this the major
federal scholarship source for undergraduate nursing students.
The goals of the SDS Program are to increase diversity in the
health professions and nursing workforce and improve access to health
care. The program provides scholarships to financially needy students
from disadvantaged backgrounds who are enrolled in schools of nursing,
and in programs of allopathic medicine, osteopathic medicine,
dentistry, veterinary medicine, optometry, podiatry, pharmacy,
chiropractic, behavioral and mental health, public health, allied
health, and physician assistants. The SDS program allows eligible
students the opportunity to pursue health professions or nursing
education by eliminating or reducing financial barriers that might
otherwise prevent these students from enrolling.
AACN recommends funding the SDS program at $43.7 million for fiscal
year 2001, a $5.61 million or 14.7 percent above the fiscal year 2000
level. AACN is a member of and supports the Health Professions and
Nursing Education Coalition's recommendation of $335 million for Public
Health Service Act Titles VII and VIII, which support health
professions and nursing education programs.
agency for healthcare research and quality (ahrq)
The mission of the Agency for Healthcare Research and Quality
(AHRQ) is to support, conduct, and disseminate research that improves
the outcomes, quality, access to, and cost and use of health care
services. This mission, which focuses on the effectiveness and value of
health care in daily practice, is unique and complements the biomedical
and behavioral research responsibilities of the NIH. The products of
the Agency include knowledge that supports decision making to improve
health care, and tools that help improve quality and reduce costs. In
view of the AHRQ's significant contributions to health outcomes, the
AACN recommends appropriate increases for the AHRQ budget in fiscal
year 2001.
national institutes of health
AACN applauds the leadership of Chairman Specter and the
Subcommittee in the continuing campaign to double the NIH budget in 5
years. The investment in biomedical and behavioral research has
propelled a remarkable transformation in our understanding of the life
sciences and has given us a bounty of new ways to prevent, treat, and
cure disease. Major threats to public health have been reduced, quality
of life has improved, and life expectancy has continued to rise. A
child born in the United States today can be expected to live 76.5
years, 3.9 years longer than a child born in 1975. AACN joins the Ad
Hoc Group for Medical Research Funding in recommending a fiscal year
2001 funding level of $20.47 billion for the NIH, a 15 percent increase
over the fiscal year 2000 level.
indian health service
Mr. Chairman, the Indian Health Services (IHS) provides vital
health services to our Native American populations and nursing
professionals have been a central component of the IHS health delivery
system since the agency's inception. The IHS provides direct health
care services in 37 hospitals, 61 health centers, 4 school health
centers, and 48 health stations. Tribes and tribal groups, through
contracts with the IHS, operate 12 hospitals, 134 health centers, 4
school health centers, and 241 health stations (including 168 Alaska
village clinics.) The IHS, tribes and tribal groups also operate 7
regional youth substance abuse treatment centers. AACN recommends
increases for the Indian Health Service for fiscal year 2001.
higher education act programs--student financial and general assistance
There are several student financial and general assistance programs
that are particularly important to the nursing community. The Pell
Grant Program helps ensure access to post secondary education for low
and middle income undergraduate students by providing grants that, in
combination with other sources of student aid, help meet post secondary
education costs. The Federal Work Study Program ensures access by
assisting needy undergraduates and graduate students in financing post
secondary education costs through part time employment. The TRIO
Programs fund post secondary education outreach and student support
services designed to encourage individuals from disadvantaged
backgrounds to enter and complete college. AACN recommends increases
for each of these programs over the levels provided in fiscal year
2000.
SUMMARY OF AACN HIGHEST PRIORITY FISCAL YEAR 2001 FUNDING
RECOMMENDATIONS
[In millions of dollars]
------------------------------------------------------------------------
Fiscal year Fiscal year 2001
Highest AACN priority ------------------------- AACN
recommendation 2000 2001 recommendation
------------------------------------------------------------------------
National Institute of Nursing 89.5 92.524 110
Research....................
Nurse Education Act.......... 67.8 65.576 78
Scholarships for 38.09 38.09 43.7
Disadvantaged Students......
------------------------------------------------------------------------
______
Prepared Statement of The Humane Society
We appreciate the opportunity to provide testimony to the Labor,
Health and Human Services, and Education Subcommittee on two funding
items of great importance to The Humane Society of the United States
(HSUS) and its 7.3 million supporters nationwide. As the largest animal
protection organization in the country, The HSUS urges the Committee to
address these priority issues in the fiscal year 2001 budget.
class b random source animal dealers
The HSUS is grateful for the leadership of Chairman Specter,
Ranking Democrat Harkin, and this Committee in raising concerns last
year about the problem of Class B dealers, who acquire the animals they
sell to biomedical research facilities from a variety of sources,
including ``free to good home'' ads, animal shelters, and outright
theft of family pets. Squalid conditions, abusive handling, sickly and
under-cared for animals, and sloppy record-keeping are the hallmarks of
Class B dealers. As Robert A. Whitney, D.V.M. and former Director of
both the National Center for Research Resources and the Office of
Animal Care and Use at NIH, testified in July 1997, ``The continued
existence of these virtually unregulatable Class B dealers erodes the
public confidence in our commitment to appropriate procurement, care,
and use of animals in the important research to better the health of
both humans and animals.''
Committee Report language accompanying the fiscal year 2000
appropriations encouraged NIH to consider extending its intramural
research practice of using only purpose-bred animals (not those
obtained from Class B dealers) to the extramural research funded by NIH
as well. Unfortunately, NIH has taken no clear steps since last year's
legislation to ensure that taxpayer dollars will not be used in the
future to support research on animals obtained through Class B dealers.
Consequently, we urge the Committee this year to direct NIH, in bill
language, not to award grants for research projects that utilize random
source dogs or cats supplied by Class B dealers. We commend NIH for its
internal research practice, but feel strongly that NIH should exercise
the same caution and concern with respect to its grant recipients. The
public deserves to know that animals used in government-funded research
have not been stolen from their families or obtained through other
disreputable means commonly employed by Class B dealers.
chimpanzee sanctuaries
We also consider it a high priority for the 106th Congress to enact
H.R. 3514, legislation to establish a federal chimpanzee sanctuary
system for the permanent retirement of chimpanzees no longer needed in
medical research. This cost-effective and humane approach to dealing
with the problem of ``surplus chimpanzees,'' who were overbred and
languish in laboratories across the country, deserves to be enacted by
this Congress. It will save taxpayers considerable money in the long
run, and significantly improve the quality of life for these animals
who have served humanity but are now simply being warehoused in costly
research facilities.
Along with the united support of the animal protection community,
H.R. 3514 has been endorsed by more than 100 members of the scientific
and academic community who have particular expertise involving
chimpanzees, as follows:
Jonathan S. Allan, D.V.M., Scientist--Department of Virology and
Immunology, Southwest Foundation for Biomedical Research (San Antonio,
TX)
American Zoo and Aquarium Association (Silver Spring, MD)
James Anderson, Ph.D., Senior Lecturer in Psychology--University of
Stirling (Stirling, Scotland)
Kate Baker, Ph.D., Research Associate--Yerkes Regional Primate
Research Center, Emory University (Atlanta, GA)
Marc Bekoff, Ph.D., Professor of Environmental, Population and
Organismic Biology--University of Colorado (Boulder, CO)
Carol Berman, Ph.D., Professor of Anthropology--University of
Buffalo (Buffalo, NY)
Tammie Bettinger, Ph.D., Curator of Conservation and Science--
Cleveland Metroparks Zoo (Cleveland, OH)
Joseph T. Bielitzki, MS, DVM, Chief Veterinary Officer--NASA
(Mountain View, CA)
Mollie Bloomsmith, Ph.D., Director of Research and Director of
TECHlab Zoo Atlanta; Affiliate Scientist--Yerkes Regional Primate
Research Center, Emory University (Atlanta, GA)
Carolyn Bocian, Ph.D.
Sarah Boysen, Ph.D., Director of Primate Cognition Project and
Associate Professor of Comparative Psychology--Ohio State University
(Columbus, OH)
Hilary O. Box, Ph.D., Senior Lecturer in Psychology--University of
Reading; Vice President for Captive Care, Primate Society of Great
Britain and the International Primatological Society (Reading, UK)
Linda Brent, Ph.D., President Chimp Haven, Inc. (San Antonio, TX)
Betsy Brotman, Director--Vilab II (Robertsfield, Liberia) and the
New York Blood Center (New York, NY)
Hannah Buchanan-Smith, Ph.D., Lecturer in Psychology--University of
Stirling, (Stirling, Scotland)
Thomas Butler, D.V.M.
Richard W. Byrne, Ph.D., Professor of Evolutionary Psychology--The
University of St Andrews; Vice President for Membership, International
Primatological Society (St Andrews, Scotland)
Nancy Caine, Ph.D., Professor of Psychology--California State
University San Marcos (San Marcos, CA)
John Capitanio, Ph.D., Associate Professor of Psychology--
University of California at Davis; Staff Scientist--California Regional
Primate Research Center
Gary Comstock, Ph.D., Associate Professor of Philosophy and
Religious Studies & Coordinator Bioethics Program--Iowa State
University (Ames, IA)
Robert Cooper, D.V.M.
Colleen Crangle, Ph.D., Computer Science (Palo Alto, CA)
Steve Davis, D.V.M., Professor of Animal Sciences--Oregon State
University (Corvallis, OR)
David DeGrazia, Ph.D., Associate Professor of Philosophy--George
Washington University; Senior Research Fellow--Kennedy Institute of
Ethics, Georgetown University (Washington, DC)
Frans de Waal, Ph.D., Chandler Professor of Primate Behavior
Psychology Department, and Director of LIVING LINKS CENTER--Yerkes
Regional Primate Research Center, Emory University (Atlanta, GA)
Wendy Dirks, Ph.D., Assistant Professor of Anthropology--New York
University (New York, NY)
Merelyn T. Dolins, Ph.D., Director of Physical Therapy--Department
of Child Development and Rehabilitation, Valley Hospital (Paramus, NJ)
Francine L. Dolins, Ph.D., Program Scientist for Research,
Behavioral Primatologist Animal Research Issues--The Humane Society of
the United States (Washington, DC)
Alessandro Duranti, Editor, Journal of Linguistic Anthropology,
Department of Anthropology--University of California at Los Angeles
(Los Angeles, CA)
Stephen Easley, Ph.D., Director--Easley and Associates,
Professional Consultants (Alamorgordo, NM)
Sian Evans, Ph.D., The DuMond Conservancy (Miami, FL)
Brian Fay, Ph.D., Professor of Philosophy--Wesleyan University
(Middletown, CT)
Jo Fritz, Director--Primate Foundation of Arizona (Mesa, AZ);
Member, National Research Council Committee that produced 1997 Report,
Chimpanzees in Research: Strategies for Their Ethical Care, Management,
and Use
Randy Fulk, Ph.D., Curator of Research--North Carolina Zoological
Park (Asheboro, NC)
Paul A. Garber, Ph.D., Professor of Anthropology--University of
Illinois (Urbana, IL)
Michele L. Goldsmith, M.S., Ph.D., Assistant Professor of
Environmental and Population Health Center for Animals and Public
Policy--Tufts University School of Veterinary Medicine (North Grafton,
MA)
Jane Goodall, Ph.D.--The Jane Goodall Institute (Silver Spring, MD)
Thomas Gordon, Ph.D., Director--Yerkes Regional Primate Research
Center, Emory University (Atlanta, GA)
Lisa Gould, Ph.D., Assistant Professor of Anthropology--University
of Victoria (Victoria, Canada)
Victoria Hampshire, D.V.M., Director--Advanced Veterinary
Applications (Bethesda, MD)
Beatrice H. Hahn, M.D., Professor of Medicine and Microbiology--
University of Alabama (Birmingham, AL)
Lynette Hart, Ph.D.
Ned Hettinger, Ph.D., Professor of Philosophy--College of
Charleston (Charleston, SC)
Robert A Hinde, Ph.D., Professor Emeritus--Cambridge University;
Fellow of the Royal Society; Honorary Foreign Associate of the National
Academy of Sciences (Cambridge, UK)
William D. Hopkins, Ph.D., Professor of Psychology--Berry College
(Rome, GA); Research Associate--Yerkes Regional Primate Research
Center, Emory University (Atlanta, GA)
Sue Howell, Ph.D., Research Director--Primate Foundation of Arizona
(Mesa, AZ)
Robert Hubrecht, Ph.D.--University Federation for Animal Welfare,
United Kingdom
Ellen Ingmanson, Ph.D. Assistant Professor of Anthropology--
Dickinson College (Carlisle, PA )
Thomas Insel, M.D. , Director--The Center for Behavioral
Neuroscience, Emory University (Atlanta, GA)
Joseph Jacquot, Ph.D., Professor of Biology--Grand Valley State
University (Allendale, MI)
Alicia Karas, D.V.M., Dipl. ACVA, Assistant Professor of
Anesthesiology--Tufts University School of Veterinary Medicine, Foster
Hospital for Small Animals (North Grafton, MA)
Michael Kastello, D.V.M, Executive Director, Research Resources--
Merck & Co., Inc. (Rahway, NJ)
James King, Ph.D., Professor of Psychology--University of Arizona
(Tucson, AZ)
Bette Korber, Ph.D., Research Scientist--Santa Fe Institute (Santa
Fe, NM)
A. Lanny Kraus, D.V.M., Dipl. ACLAM, Professor Emeritus--Division
of Laboratory Animal Medicine, University of Rochester School of
Medicine & Dentistry, (Rochester, NY)
Susan P. Lambeth, Environmental Enrichment Director--M.D. Anderson
Cancer Center (Bastrop, TX)
Louise Lamphere, Ph.D,, Professor of Anthropology--University New
Mexico (NM)
Virginia Landau, Ph.D., Staff Primatologist--The Jane Goodall
Institute (Silver Spring, MD); Director--ChimpanZoo (Tucson, AZ)
Clark Larsen, Ph.D., Amos Hawley Professor of Anthropology--
University of North Carolina (Chapel Hill, NC)
Alecia Lilly, Ph.D., Research Fellow--Department of Anthropology,
State University of New York (Stony Brook, NY)
Orla Mahoney, D.V.M.--Tufts University, School of Veterinary
Medicine (North Grafton, MA)
Terry Maple, Ph.D., President and CEO--Zoo Atlanta (Atlanta, GA)
Linda Marchant, Ph.D., Professor of Anthropology--Miami University
(Oxford, OH)
Preston A. Marx, Ph.D., Senior Scientist and Professor of Tropical
Medicine--Tulane University Medical Center (Covington, LA) and Aaron
Diamond AIDS Research Center (New York, NY)
William C. McGrew, Ph.D., Professor of Zoology--Miami University
(Oxford, OH)
Patrick Mehlman, Ph.D., Director of Mondika Primate Research
Center--Department of Anthropology, State University of New York (Stony
Brook, NY)
Robert Mitchell, Ph.D., Associate Professor of Psychology--Eastern
Kentucky University (Richmond, KY)
John Moore, Ph.D., Scientist--Aaron Diamond AIDS Research Center,
The Rockefeller University (New York, NY)
Toshisada Nishida, Ph.D., Professor of Anthropology, President of
the International Primatological Society--Kyoto University (Kyoto,
Japan)
April Nowell, Ph.D., Professor of Anthropology--University of
Victoria (Victoria, Canada)
John Oates, Ph.D., Professor of Anthropology--Hunter College, City
University of New York (New York, NY)
Barbara Orlans, Ph.D., Senior Research Fellow--Kennedy Institute of
Ethics, Georgetown University (Washington, D.C.)
Sue Taylor Parker, Ph.D., Professor of Anthropology--Sonoma State
University (Rohnert Park, CA)
Gary J. Patronek, VMD, PhD, Director--Tufts Center for Animals and
Public Policy (North Grafton, MA)
Andrew Petto, Ph.D., Editor and Assistant Professor--National
Center for Science Education, University of the Arts (Philadelphia, PA)
Evelyn Pluhar, Ph.D., Professor of Philosophy--Penn State
University (University Park, PA)
Trevor Poole, Ph.D.--University Federation for Animal Welfare
(England)
Alfred M. Prince, M.D.--The New York Blood Center (New York, NY)
Jill Pruetz, Ph.D. Postdoctoral Fellow--Department of Anthropology,
Miami University (Oxford, OH)
Anne E. Pusey, Ph.D., Distinguished McKnight Professor of Ecology,
Evolution & Behavior--University of Minnesota (St Paul, MN)
Ed Ramsey, D.V.M., University of Tennessee
Viktor Reinhardt, Ph.D., Laboratory Animal Specialist--Animal
Welfare Institute (Washington, DC)
Vernon Reynolds, Ph.D. Professor of Biological Anthropology--
Institute of Biological Anthropology, Oxford University (Oxford, UK)
Anthony Rose, Ph.D., Director--The Biosynergy Institute (Hermosa
Beach, CA)
William E. Roudebush, Ph.D., Associate Professor of Obstetrics &
Gynecology and Molecular Cell Biology & Pathobiology; Treasurer,
International Primatological Society--Medical University of South
Carolina (Charleston, SC)
Andrew N. Rowan, D. Phil., Senior Vice President of Research,
Education & International Affairs--The Humane Society of the United
States (Washington, DC)
Thomas Jefferson Rowell, D.V.M., Director--University of
Southwestern Louisiana, Lafayette-NIRC (New Iberia, LA)
Duane Rumbaugh, Ph.D., Director--Language Research Center, Georgia
State University (Atlanta, GA)
Lilly-Marlene Russow, Ph.D., Professor of Philosophy--Purdue
University (West Lafayette, IN); Member, National Research Council
Committee that produced 1997 Report, Chimpanzees in Research:
Strategies for Their Ethical Care, Management, and Use
Anthony Rylands, Ph.D.--Conservation International and IUCN/SSC,
Primate Specialist Group
Dale Schwindaman, D.V.M.
Jack F. Sharp, President--Biomedical Research Foundation of
Northwest Louisiana (Shreveport, LA)
James Serpell, Ph.D., Associate Professor of Humane Ethics & Animal
Welfare, and Director--Center for the Interaction of Animals & Society,
Department of Clinical Studies, School of Veterinary Medicine,
University of Pennsylvania (Philadelphia, PA)
Yukimaru Sugiyama, Ph.D., Professor Emeritus of Kyoto University
and Dean of Faculty of Humanities--Tokai-gakuen University; President
of Primate Society of Japan
Erna Toback, Ph.D., Assistant Professor of Psychology--Santa Monica
College (Santa Monica, CA) and University of Stirling (Stirling,
Scotland)
Joel Trupin, Ph.D. Professor of Biochemistry--Meharry Medical
School (Nashville, TN)
Caroline Tutin, Ph.D., Senior Research Fellow--Centre International
de Recherches Medicales, (Franceville, Gabon); Department of Biological
and Molecular Sciences--University of Stirling (Stirling, Scotland)
Augusto Vitale, Ph.D., Research Fellow in Animal Behaviour Section
of Comparative Psychology--Laboratorio di Fisiopatologia di Organo e di
Sistema, Istituto Superiore di Sanita' (Rome, Italy)
Janette Wallis, Ph.D., Associate Professor of Research--Department
of Psychiatry & Behavioral Sciences, University of Oklahoma Health
Sciences Center (OK)
Lyna Watson, Ph.D. Affiliated Scientist--Zoo New England (Boston,
MA)
Francoise Wemelsfelder, Ph.D., Research Fellow in Animal Welfare,
Animal Biology Division--Scottish Agricultural College (Edinburgh,
Scotland)
Brent C. White, Ph.D., Matton Professor of Psychology--Centre
College (Danville, KY)
Roger D. White, M.D., Anesthesiology (Rochester, MN)
Thomas Wolfle, D.V.M., Retired Director--Institute of Laboratory
Animal Research, National Research Council; Program Director, National
Research Council Committee that produced 1997 Report, Chimpanzees in
Research: Strategies for Their Ethical Care, Management, and Use
Richard Wrangham, Ph.D., Professor of Anthropology--Department of
Anthropology, Harvard University (Cambridge, MA)
Stephen L. Zawistowski, Ph.D., Certified Applied Animal
Behaviorist, Senior Vice President and Science Advisor--The American
Society for the Prevention of Cruelty to Animals; Co-Editor, Journal of
Applied Animal Welfare Science (New York, NY)
The HSUS was very pleased to learn of the possibility, raised by
House Subcommittee Chairman John Porter at a recent hearing, that H.R.
3514 may be incorporated into the fiscal year 2001 Labor-HHS
Appropriations bill. We would strongly support that as a way to ensure
enactment of this vital legislation in the 106th Congress. We also
strongly support efforts in this appropriations bill to address the
crisis facing hundreds of chimpanzees at The Coulston Foundation in
Alamogordo, New Mexico, where recurrent mismanagement and inappropriate
veterinary care have caused several painful and needless chimpanzee
deaths.
Again, we appreciate the opportunity to share our views and
priorities for the Labor, Health and Human Services, and Education
Appropriation Act of fiscal year 2001. We hope the Committee will be
able to accommodate these requests to alleviate some very pressing
problems affecting animals across the United States. Thank you for your
consideration.
______
Prepared Statement of the National Sleep Foundation
Mr. Chairman, distinguished Members of this Subcommittee, thank you
for allowing us to present testimony on fiscal year 2001 Appropriations
for the Centers for Disease Control and Prevention.
The National Sleep Foundation (NSF) is a science-based, non-profit
voluntary health organization dedicated to promoting awareness about
the importance of good sleep, sleep disorders, and the consequences of
sleep deprivation.
The National Institutes of Health estimates that 40 million
Americans suffer from chronic sleep disorders the vast majority of
which remain undiagnosed and untreated and another 20 to 30 million
suffer intermittent sleep-related problems. An NSF survey found that
fifty-eight million Americans report suffering excessive daytime
sleepiness at levels that interfere with their day-to-day activities.
Evidence tells us that Americans sleep debt is on the rise, yet
numerous studies have concluded that the general public and primary
care physicians lack the basic sleep knowledge to address these
problems. As a result, the toll on human health, safety and
productivity is enormous. NSF and sleep experts like myself take this
chronic sleep deprivation very seriously. Lack of adequate amounts of
sleep has been associated with significant physical and mental
problems. For example, cardiovascular disease, gastrointestinal
disorders, mood disorders and drug abuse are more prevalent among shift
workers. This problem is more than simply getting a good nights rest.
It encompasses medical problems, lack of education, and the tools
required to address this public health crisis.
Sleepiness, whether the result of untreated sleep disorders or
volitional sleep deprivation has been identified as a causal factor in
a growing number of on-the-job injuries. This corresponds directly in
lost productivity, personal injuries, medical expenses, property and
environmental damage due to fatigue, sleep disorders and sleep
deprivation and is estimated to exceed $100 billion each year. It is,
however, the personal injuries that are the most tragic part of this
equation. In my daily practice, I routinely hear stories of drivers who
fall asleep at the wheel and kill themselves, a family member, or an
innocent bystander.
In the first-ever case-controlled epidemiological study of drowsy
driving crashes recently completed by one of our partners, the AAA
Foundation for Traffic Safety, work and sleep schedules were strongly
associated with involvement in a sleep-related crash. Compared to
drivers in non-sleep crashes, drivers in sleep crashes were nearly
twice as likely to work at more than one job and their primary job was
more likely to involve an atypical schedule. This characterizes many
Americans and yet, represents a crisis in our country that remains to
be largely unaddressed except by organizations like the National Sleep
Foundation and AAA.
The National Sleep Foundation has taken some small steps to work on
lowering the number of injuries associated with sleepiness. NSF, in
cooperation with many partners, has successfully mounted state programs
in New York, Arkansas, California, Washington, Oregon and Idaho that
target fatigue-related injuries. In New York, NSF worked with state and
federal agencies and other partners to launch the nations first
statewide public information and injury prevention program related to
the dangers of sleep deprivation. Unfortunately, NSF alone does not
have the resources to continue to mount these state-by-state campaigns.
Information gathered by our sleep polls and work in the states also
suggests that the percentage of population adversely affected by
sleepiness is higher than current statistical information provides.
Let us provide one example that illustrates the problem. The AAA
study points out that countermeasures or strategies that drivers
typically employ, rolling down the car windows, turning up the radio,
or stopping to stretch are largely unsupported by the scientific
literature. Yet these strategies were often cited by our drivers and
are believed by them to be anywhere from somewhat, to very effective in
countering drowsy driving. Let us be clear almost all experts agree
that the only truly effective strategy drowsy drivers can take to
prevent a crash is to immediately stop driving and get some sleep. If
this is not possible, drivers should be encouraged to stop, drink some
caffeine (the equivalent of two cups of coffee), and take a brief nap
before getting back behind the wheel.
Traffic safety data is incomplete due to the difficulty in
measuring the role sleepiness played in an accident investigation. This
is in part due to the fact that sleepiness is often overlooked when
investigating work or traffic related injuries. This problem exists in
every area that sleepiness is a problem. Yet we believe, through work
at the National Center for Injury Prevention and Control at the Centers
for Disease Control and Prevention (CDC), we can begin to adequately
address this crisis, particularly in the area of physician education.
In our discussions with CDC it is clear that sleepiness crosscuts
many centers. This is not only an issue for the National Center for
Injury Prevention and Control but also the National Institute for
Occupational Safety and Health and the National Center for Chronic
Disease Prevention and Health Promotion at the very least. The common
question of all these Centers revolves around data collection. It is
this first step we would propose that the Subcommittee consider
providing funding for.
The NSF has the network of experts in the sleep field. The CDC has
links to other health divisions who address at risk patient populations
including shift workers and adolescents. We seek support for the
development of evaluative research, including data collection, through
the National Center for Injury Prevention and Control at CDC. This
would likely include an attempt to validate or improve existing surveys
and survey methodologies. It would also evaluate new ways to capture
data and validate program effectiveness. The data from this research
will allow us to develop accurate and informative material and model
programs to provide to states as they address these important issues.
NSF experts are willing to work with CDC to reach out to
corporations and other partners to develop accurate data collection
methods to identify the scope of the problem. One area where more data
would be helpful is with the accurate medical diagnosis of sleep
disorders. A recent study in Walla Walla, Washington concluded that
sleep apnea is significantly under recognized by primary care
physicians. The study was done through the utilization of primary care
physicians who were trained to recognize the warning symptoms of
certain sleep disorders. With this training, physicians were able to
diagnose and ultimately recommend treatment to hundreds of people for
sleep apnea and restless legs syndrome. These disorders are not unique
to Walla Walla, but are believed to affect millions of Americans.
Patients are receiving no diagnosis or treatment due to a general lack
of training within the physician community. In this instance, a
significant public health problem is identified and a solution
established. Accurate data from the health care community along with
additional training would show the extent of the problem and allow us
to target physicians who are on the front lines of our health care
system.
Current CDC resources within the National Center for Injury
Prevention and Control are allocated for other projects that are of
equal importance to the country. It is with this recognition that we
ask the subcommittee to increase the overall budget for this center by
$1.2 million to allow the Center to act as the coordinating body for
the gathering and evaluation of the types of data discussed above.
This data will allow the NSF, CDC, and other federal agencies to
develop and distribute accurate medically sound information. This
information coupled with training for those involved with public health
and safety at the state level will begin to turn the tide of injuries
and costs associated with sleepiness and sleep disorders.
Thank you for consideration of this request.
______
Prepared Statement of the National Center for Learning Disabilities
Mr. Chairman, my name is Anne Ford and I am the volunteer Chairman
of the Board of Directors for the National Center for Learning
Disabilities (NCLD). NCLD is a not-for-profit organization founded in
1977, which seeks to ensure that all individuals with learning
disabilities (LD) gain access to research-based knowledge and
opportunities to fully achieve their potential. NCLD protects the
rights of individuals with LD and promotes the widespread
implementation of effective research-based instructional methods. As
Chairman of NCLD for the past ten years, and as a parent of a child
with learning disabilities, I am keenly aware of the need for greater
access to services and increased awareness among parents, early child
care providers, teachers and other professionals about how early
recognition and intervention can lead to greater success for children
in school and beyond.
I am pleased to submit this testimony to encourage the committee's
endorsement of a Literacy Early Screening Initiative supported by the
National Institute of Child Health and Human Development (NICHD), in
partnership with NCLD. The focus of the initiative is to assure that
parents, early child care providers, teachers and other professionals
have a research-based, easy-to-use tool to screen preschool-age
children for behaviors that place them at risk for reading failure, and
the information, training and support to implement screening on a
nationwide basis.
background
The impetus for this early reading screening initiative comes from
the convergence of data from a number of sources. Studies of early
learning (Ramey, et al, 1985), patterns of early care in families
(Hofferth, 1996), the efficacy of early instruction and intervention
(Snow, et al, 1998), the benefits of quality child care (Phillips, et
al, 1987), early brain development (Huttenlocher, 1995), and the
benefits of early identification of risk factors in young children
(Fletcher et al, 1994) all support the initiative's premise that
learning difficulties identified early in a child's life can circumvent
the longer-term consequences of school failure.
Due in great part to longitudinal studies conducted by NICHD, there
is already a considerable body of evidence regarding the specific
aspects of young children's physical, cognitive, and social behaviors
that are most predictive of later learning difficulty, particularly in
the area of early reading and related literacy skills (National Reading
Panel, 2000). Studies have shown that learning to read is a process
that begins very early in development, well before children enter
formal schooling. There is a strong and critical relationship between
the amount and quality of early language, literacy interactions and
experiences, and the acquisition of linguistic skills necessary for
reading (Lyon, 1999).
need for research-based screening
A number of complementary efforts are underway to ensure that the
United States becomes a nation of readers. The America Reads Challenge,
the Reading Excellence Program and the creation of the National
Institute for Literacy are a few examples of major efforts through
which commitments have been made by the federal government. These
programs are working to enable all citizens, both young and old, with
and without special educational needs, to develop strong reading and
other literacy skills. These and other successful programs show how
government and private organizations are working to assure universal
school readiness to all our nation's youth.
There is a shared vision among parents, early care providers,
educators, and policy officials to develop strong reading and other
literacy skills in our nation's children. However, there has been no
coordinated effort to date that addresses the need of parents and early
care providers to identify children who show signs of early literacy
difficulties and, in particular, to provide research-based information
and support. This initiative will provide parents and early care
providers with an understanding of these findings, an ability to screen
children for behaviors that place them at risk for reading failure, and
the information needed to take effective steps toward assuring all
children early success in learning to read.
the initiative
Through the Literacy Early Screening Initiative, NCLD, under the
direction of NICHD, will direct the development of a research-based
screening tool. This tool will reflect the most current knowledge on
reliable early predictors of reading success and early identification
of literacy problems in the preschool and early elementary grades. The
initiative will create and support a development team of national
experts to design the screening tool. An advisory committee will also
inform the ongoing collaborative relationships upon which the
implementation of the initiative will be based.
As a leading not-for-profit organization committed to the well
being of all children, including those with learning disabilities, NCLD
is ideally suited to work with NICHD and launch a collaborative
initiative of this nature. In May 1999, NCLD hosted a national summit
on research in learning disabilities in partnership with the U.S.
Department of Education, Office of Special Education Programs (OSEP)
and the National Institutes of Health, NICHD. With our partners, NCLD
released syntheses of 20 years of study and convened over 400 national
leaders to propose ways to shorten the distance between research and
classroom practice.
In the first phase of the project, NCLD will take the following
steps to launch the initiative in Kentucky and Mississippi:
--Establish a nationally recognized Development Team to assess the
research evidence and select key predictors for the core of the
tool.
--Establish an Advisory Committee of nationally recognized experts to
provide ongoing expertise and guidance.
--Engage a Project Director to manage the work.
--Identify successful strategies to reach target audiences.
--Design and pilot test the screening tool.
--Confirm partnerships in key states for roll out.
--Develop content and infrastructure on NCLD's Web site and other
information sources.
--Conduct outcome evaluation activities.
--Develop a plan for national roll out.
implementation
Once the screening tool is developed, training, dissemination, and
marketing activities will be carried out in Kentucky and Mississippi in
partnership with early childhood education, child care, and family
support organizations as well as with professional organizations whose
activities focus on the well-being of young children and their
families. Local and national partners may include:
--American Library Association
--National Association for the Education of Young Children
--National Association for Family Childcare
--National Center for Family Literacy
--National Head Start Association
--National Institute for Literacy
--National Parent Teachers Association
--Reach Out and Read
--WGBH/Between the Lions
--Yale University Bush Center/21st Century Schools
--University of Louisville
--University of Southern Mississippi/Center for Literacy and
Assessment
Working in partnership, we will use select media conduits and other
methods known to be effective in reaching specific groups of
individuals such as parents of preschool-age children, early childhood
educators, health care professionals, and other information and service
providers.
Based on its own research and marketing strategies, the project
will ensure extensive use of the tool by promoting its `user
friendliness' and utility for non-expert users through its own and
other organizations' Web sites. Opportunities for volunteer marketing
through food, toy and clothing manufacturers will also be explored, as
will ways to incorporate information about the screening tool in
corporate employee assistance programs and human resource services. Of
special interest will be opportunities to promote the use of this early
screening tool through relationships with major PBS outlets.
Mr. Chairman, by supporting this project, you have the chance to
bring our collective investment in research to the next level. It's an
exciting challenge and opportunity. Together, we can help parents and
others vested in our children's success have direct access to an easy-
to-use tool that can determine whether to seek early intervention and
professional assessment to prevent reading failure. By spending a
limited amount of time and money early in a child's life, we can help
prevent spending hundreds of thousands later. Perhaps we can stop the
heartache and frustration that comes from wondering what could have
been done if we had only known. Let's take action with the reliable
science available to us and give young children an early chance at
success in school and in their lives. Thank you for your consideration
and support.
______
Prepared Statement of the Council for Chemical Research
Issue.--The National Institutes of Health (NIH), through the
National Institute of General Medical Sciences (NIGMS), is one of the
largest funders of synthetic chemistry--the heart of advances in
medicinal chemistry. While the Administration's requested fiscal year
2001 budget for NIH contains a 5.6 percent increase, it fails to meet
the 7 percent needed to reach the congressional goal of doubling
federal spending on research in ten years.
position
The Council for Chemical Research (CCR) endorses the congressional
goal of doubling the total federal spending on research within a
decade. To achieve this end requires an average increase for NIGMS of 7
percent each year for ten years. For this reason, the CCR applauds the
commitment Congress made to NIH with the approval of a 14.2 percent
increase for fiscal year 2000. The Council believes that in the
present, strong economy it would not be prudent for the NIH-NIGMS
budget to increase at a rate less than the 7 percent average needed to
reach our mutual goal. Therefore, the CCR strongly supports increasing
the federal investment in NIH beyond the Administration request to
further strengthen the national investment in basic research, since
discoveries in biomedical research are very highly dependent progress
in chemistry and chemistry related sciences. Moreover, increasing our
investment in research will lay the basis for the future continuation
of our strong economy.
rationale
NIGMS provides the enabling research and training for the
biomedical community that underpins the advances and discoveries of
other NIH institutes. This Institute is responsible for generating
basic knowledge and new technologies which is the spring from which
discovery in the biomedical field pours. NIGMS supports three crucial
aspects of chemical research:
--Basic research in chemistry provides the foundation of many
biomedical advances. It has led to combinatorial chemistry
methods and rational drug design, which allow for the more
efficient development of pharmaceuticals having greater
potency, higher selectively, and fewer side effects.
--The single most important element of any research program is the
presence of well-trained, talented, and dedicated
investigators. Training programs at NIGMS develop the multi-
disciplinary skills demanded by modern biomedical and
pharmaceutical research. Well-trained researchers not only
increase productivity for the rapidly expanding biotechnology,
pharmaceutical, and diagnostic industries, but also help
maintain the world leadership of these industries in extremely
competitive markets. Moreover, to maintain this strong pool of
researchers the first priority in allocating NIH budget
increases should be to support more investigator-initiated
research grants and to fund this increased number of proposals
at the appropriate levels needed for their successful
execution.
--Basic research requires access to modern instrumentation ranging
from computers to high-field nuclear magnetic resonance (NMR)
spectrometers, laser systems, x-ray light sources, and mass
spectrometers. Emphasis on high performance computing
applications in basic biomedical studies is a particularly
timely use of resources. These instruments enable researchers
to directly observe the fundamental chemical and biomedical
processes involved in life and to gain much-needed insight into
the workings of the chemistry of living organisms. Through
continued modification and refinement, research instruments
often develop into clinically important tools. Thus,
instrumentation supported by the National Center for Research
Resources (NCRR) plays a crucial role in providing the
underpinning for biomedical research.
Research in chemistry supported by NIGMS and NCRR provides the
strong foundation necessary to ensure progress in the quest for
improvements in health and the quality of life. The CCR supports
strengthening NIH since it provides training for new scientists,
stimulates the pharmaceutical and biotechnology industries--both of
which contribute positively to the balance of trade--leads to reduced
healthcare costs, healthier lives, and, ultimately, makes the United
States a world leader in biomedical research.
______
Prepared Statement of the Joslin Diabetes Center
introduction
Mr. Chairman, I am Dr. Gordon Weir, Chief of Section on Islet
Transplantation and Cell Biology and former Medical Director of the
Joslin Diabetes Center in Boston, Massachusetts. I am here today to
request for full funding of the first year recommendations of the
report issued by the Congressionally mandated Diabetes Research Working
Group.
background
Diabetes Research Working Group.--The Diabetes Research Working
Group was established by this Subcommittee and its Senate counterpart
through the fiscal year 1999 Conference Agreement, House Report 105-
635.
The charge to the Diabetes Research Working Group called for the
development of a comprehensive plan for all NIH-funded diabetes
research efforts, including the recommendations of future diabetes
research initiatives and directives. The Conference Agreement language
specifically instructed the DRWG to include overall cost estimates to
accomplish its recommendations in the final research plan. The final
report was provided to the Appropriations Committees in mid 1999.
Fiscal year 2001 will be the first year the Congress can act on the
funding recommendations contained within the DRWG Report.
The Chairman of the Diabetes Research Working Group, C. Ronald
Kahn, M.D., a distinguished researcher, is the former Executive Vice
President and Research Director and now President of Joslin Diabetes
Center in Boston.
Fiscal year 1999 base funding for the categories addressed in the
DRWG report totaled $442.8 million. The DRWG recommended increment for
the first of five years over the fiscal year 1999 base was $384.5
million, for a total recommended funding level of $827.3 million.
H. Res. 325.--On November 16, 1999, in the closing days of the
First Session of the 106th Congress, H. Res. 325 was considered and
approved by the House 414-0. Every Member of this Subcommittee, and
every Member of the Full Appropriations Committee, voted YEA on the
passage of H. Res. 325. A similar resolution passed the Senate 93-0.
In voting for H. Res. 325, you individually and collectively
approved the principles underlying the recommendations for funding that
were contained in the report submitted by the Diabetes Research Working
Group.
The first component of H. Res. 325 expresses ``the sense of the
House of Representatives that:
--the Federal Government has a responsibility
--to continue to increase research funding, as recommended by the
Diabetes Research Working Group, so that the causes of, and
improved treatment and cure for, diabetes may be discovered . .
.''
Fiscal year 2000 funding resulted in an increase for diabetes
research of approximately 15 percent above the fiscal year 1999 funding
level.
fiscal year 2001 funding
The fiscal year 2001 Budget for NIH, and specifically NIDDK,
requests increased funds for NIH research, though not at the level
recommended by the Diabetes Research Working Group. We realize that
funding constraints represent a significant obstacle to reaching the
diabetes research levels the DRWG recommends for fiscal year 2001. If
the Committee is unable to increase the diabetes research
recommendations with the DRWG of an increase of approximately $350
million, there are immediate priorities that we would urge you include
within funding for fiscal year 2001 appropriations.
Dr. Kahn, Chairman of the DRWG, has indicated that, absent full
funding at $827.3 million for diabetes research in fiscal year 2001,
the following categories represent the highest priority among the DRWG
recommendations. While we still request the full increase recommended
by the DRWG, the following four categories represent the most urgently
requested activities, which total $79 million, in increases above the
fiscal year 2001 President's Budget:
--Create new Comprehensive Diabetes Research Centers to provide
enhanced infrastructure support, and enhance the effectiveness
of existing Diabetes Centers (DERCs and DRTCs) by significantly
increasing their funding levels and expanding their mission ($6
million);
--Create new regional centers with advanced technologies required for
metabolic and functional imaging studies, such as nuclear
magnetic resonance (NMC), positron emission tomography (PET),
and related technologies, which are required for contemporary
diabetes research, and provide ongoing support ($5 million);
--With regard to Autoimmunity and the Beta Cell ($30 million):
Define the immunological basis of type 1 diabetes and develop
methods for prevention of the disease;
Advance research on islet cell transplantation for treatment of
diabetes; and
Develop methods to stimulate beta cell growth and regeneration; and
--With regard to Cell Signaling and Cell Regulation ($38 million):
Complete the dissection of hormone signaling pathways, particularly
the pathways of insulin action, and define their
alterations in diabetes, including insulin resistance;
Define mechanisms regulating beta cell function and their
alterations in type 2 diabetes; and
Allow metabolic staging of diabetes and identify the mechanisms of
complications.
Thank you, Mr. Chairman, for this opportunity to present the views
and recommendations of Joslin Diabetes Center for diabetes research
funding through NIH in fiscal year 2001.
______
Prepared Statement of the Lovelace Respiratory Research Institute
Mr. Chairman and Members of the Subcommittee: I appreciate the
opportunity on behalf of the Lovelace Respiratory Research Institute
(LRRI) to endorse and elaborate upon the written testimony of Dr. Clyde
B. McCoy from the University of Miami School of Medicine (UMSM), with
whom we are collaborating for our proposed Minority Health Tobacco
Research Center (MHTRC).
impact of smoking
Nicotine is a drug. It is a highly addictive drug that is
unregulated. It is also a drug that appears to have profound inhibitory
effects on the mammalian immune system. The delivery system of choice
for this drug is the cigarette. There is no doubt that the use of
tobacco products causes untold human injury and suffering.
What is less well studied is the effect of secondary smoke (and by
inference the delivery of nicotine to non-smokers) on the health of
family members and co-workers of addicted users of these products. We
propose the creation of a Center designed to study the physiology and
behavioral medicine of secondary smoke combining the unique
capabilities of two leading complementary research institutions: the
University of Miami School of Medicine and its Drug Abuse Research
Center and the Lovelace Respiratory Research Institute in New Mexico.
Extensive experience in health research at UMSM in minority
substance abuse and minority health will be linked to the world class
physiology, cell and molecular biology and toxicology expertise present
at LRRI to model the role of secondary smoke on the biology of the
individual using cellular and rodent models followed by studies of
family members of smokers. Medical and behavioral interventions will
then be developed based on the resulting data.
the need to focus on the minority population
Surgeon General David Satcher reported in a March 23, 2000 news
release that there is an increase in tobacco use, especially among
teens from African American, American Indian and Alaska Natives, Asian
Americans, Pacific Islanders, and Hispanic communities. This increase
in use will lead to an increase in cancer, heart disease, emphysema,
stroke and other diseases among minorities. In addressing this
increase, the Surgeon General noted, ``Unless they are reversed, these
increases in tobacco use are a time-bomb for the health of our minority
populations . . . If tobacco use continues to increase among minority
adolescents, we can expect severe health consequences to begin to be
felt in the early part of the next century.''
``This new report clearly shows tobacco's increasing grip on racial
and ethnic minorities--the fastest growing segments of the American
population,'' said HHS Secretary Donna E. Shalala. ``This new report
underscores the need for Congress to pass comprehensive tobacco
legislation this year based on the President's five key principles that
include a significant price increase and plans to dramatically reduce
youth tobacco use.''
Of particular relevance to this proposal to fund the MHTRC, were
the following major conclusions:
--``Cigarette smoking is a major cause of disease and death in each
of the four population groups studied in this report . . .
Differences in the magnitude of disease risk are directly
related to difference in patterns of smoking . . .
--No single factor determines patterns of tobacco use among racial/
ethnic minority groups . . . These patterns are the result of
complex interactions of multiple factors, such as socio-
economic status, culture characteristics, acculturation,
stress, biologic elements, targeted advertising, price of
tobacco products, and varying capacities of communities to
mount effective tobacco control initiatives.
--Rigorous surveillance and prevention research are needed on the
changing cultural, psychosocial, and environmental factors that
influence tobacco use to improve our understanding of racial/
ethnic smoking patters and identify strategic tobacco control
opportunities. The capacity of tobacco control efforts to keep
pace with patterns of tobacco use and cessation depends on
timely development of appropriate community-based programs to
address the factors involved.'' (emphasis added)
Please note that the report went on to call for more research into
the effects of tobacco use among the groups, and called for studies to
determine the health effects of exposure to secondhand smoke.
Given the concentration of the Native American population in New
Mexico, the focus of the MHTRC will also include American Indians. The
Surgeon General found that ``Nearly 40 percent of American Indian and
Alaska Native adults smoke cigarettes, compared with 25 percent of
adults in the overall U.S. population. They are more likely than any
other racial/ethnic minority group to smoke tobacco or use smokeless
tobacco . . . American Indians . . . were only one of the four major
U.S. racial/ethnic groups to experience an increase in respiratory
cancer death rates in 1990-1995.'' (www.cdc.gov/tobacco)
The bad news continues. The need to focus on the minority
population is even more significant given the underutilization of the
health system by the population. This disturbing fact is documented in
a recent study produced by the Commonwealth Fund and published on
February 18, 2000. The report discovered that Hispanics account for an
alarming one-quarter of the nation's 44 million uninsured people.
According to the report, ``Nearly 40 percent of Hispanics under the age
of 65 do not have insurance. Despite their increasingly vital
contribution to the nation's economy.'' Hispanics are twice as likely
as the general population to go without coverage. ``Overall, 18 percent
of the population under age 65 has no health insurance . . . Among
whites, one of seven lacks insurance; among blacks, one of four lacks
insurance; and among Hispanics, nearly two of five is uninsured. . .
.'' ([email protected])
lrri and umsm are uniquely qualified to address tobacco and harmful
substance addition in the minority population
As Dr. McCoy points out, the University of Miami School of Medicine
researchers have significant expertise and experience in the treatment
of tobacco-related disease including the evaluation of Florida's
Tobacco Pilot Program. LRRI has also gained a national reputation for
its research work in the areas of prevention and cure of respiratory
disease.
Because of LRRI's unique capabilities to perform basic science
research, LRRI and UMSM bring their strengths to the formation of the
MHTRC. LRRI has undertaken some of the leading studies of animal models
of smoking and the role of nicotine in immune function. It is one of
the few research organizations capable of undertaking complex
inhalation exposure protocols with appropriate animal models that
predict human physiological responses.
bottom line
LRRI will undertake experimental protocols investigating the role
of second hand smoke on neonates, children and adults. These models
determine the precise immunological defects that result from these
exposures. This data will then be compared to the cellular immune
function of newborns, older children, and family members of minority
subjects.
UMSM will use its experience with understanding the unique cultural
and social systems found in these minority populations, and as
preserved in their unique database, to tailor medical and behavioral
interventions to treat and prevent this terrible disease, not only on
those who choose to smoke, but more importantly, on those who are
exposed, yet have no choice.
______
Prepared Statement of the American Society of Clinical Oncology
The American Society of Clinical Oncology (ASCO) represents more
than 14,000 physicians involved in cancer research and treatment. ASCO
is the leading voice among medical professional societies concerning
issues of cancer clinical research. The Society is pleased to have the
opportunity to comment on fiscal year 2001 appropriations for the
National Institutes of Health (NIH) and other issues related to the
mission of NIH. These matters are of great importance to clinical
researchers and their patients.
fiscal year 2001 appropriations for nih and nci
ASCO applauds the commitment of this Subcommittee to doubling the
budget for NIH between 1999 and 2003. This panel's leadership has been
essential to ensure predictability and stability in the NIH
appropriation and allow scientists to pursue exciting new research
endeavors. We believe the biomedical research effort of this country is
as strong as it has ever been, in no small part because of the
unwavering support of Congress.
In order to sustain progress toward the goal of doubling the NIH
budget by 2003, a funding boost of 15 percent is necessary in 2001. We
strongly support a 15 percent increase for NIH. In addition, we
recommend that funding for the National Cancer Institute (NCI) be
enhanced in accordance with the Bypass Budget. Funding NCI at a level
of $4.1 billion will allow the Institute to fund promising and
innovative investigator-initiated research proposals and facilitate
research that capitalizes on important advances in molecular biology.
ASCO believes the Bypass Budget includes a persuasive rationale for
boosting the NCI budget to $4.1 billion, and we urge the Subcommittee
to begin the new millennium by implementing the Bypass Budget
recommendation.
clinical research study section
If promising basic research advances are to have meaning for
Americans, they must be translated into medical practice. This
translation process can only be accomplished through clinical research.
Unfortunately, investigator-initiated clinical research proposals have
historically not fared well at NIH because they have been reviewed by
basic researchers who are not well versed in clinical research. ASCO
has maintained that allowing basic researchers to dominate the review
of cancer clinical research proposals is inequitable, a position
endorsed by several blue ribbon panels charged with oversight of the
NIH peer review process. Furthermore, according to recent reports,
physician scientists' success in obtaining NIH funding for
investigator-initiated research has a significant impact on their
willingness to remain in the field. Therefore, the research review
process has a significant impact on today's research and on the future
of clinical research.
ASCO has previously brought the issue of peer review of cancer
clinical research to the attention of this Subcommittee, and the panel
has supported efforts to improve the grants evaluation process. As a
result of Subcommittee directives to the NIH, the Center for Scientific
Review (CSR) appointed a special emphasis panel to review clinical
oncology research proposals. The special emphasis panel is composed of
clinical researchers who have the expertise and experience to evaluate
cancer clinical research proposals. The early reports from the special
emphasis panel have been positive. ASCO believes this model for review
has been successful and should be made a permanent study section. We
believe this would result in a system of fair and informed review of
clinical oncology research.
We are concerned, however, that CSR has announced plans to
reinstate a system in which clinical oncology research proposals will
be evaluated by panels in which as few as one-third of the members will
have clinical research expertise. This situation--where basic
researchers dominate the review of clinical research proposals--is one
that external NIH advisors recommended be avoided. ASCO urges the
Subcommittee to renew its directive to NIH officials to maintain a peer
review system that has clinical researchers reviewing cancer clinical
research proposals. ASCO believes that a rigorous and fair peer review
system is fundamental to a strong clinical research effort and urges
the Subcommittee to ensure that clinical researchers will review
clinical research proposals.
clinical trials coverage
ASCO has worked for several years for enactment of the Medicare
Cancer Clinical Trials Coverage Act, which would require Medicare to
reimburse the routine patient care costs for those enrolled in cancer
clinical trials. More recently, we have been actively involved in
efforts to ensure clinical trials coverage provisions in the Patients'
Bill of Rights. Although coverage for routine patient care costs is not
technically a matter for this Subcommittee, assurance of such coverage
is critical to the efficiency of the research enterprise and is
therefore surely a concern for this panel. Only if treatments can be
tested in clinical trials can clinical researchers determine their
effectiveness. If reimbursement denials or the fear of such denials
slow accrual to clinical trials, this will adversely affect the ability
of researchers to answer questions about new treatments. ASCO believes
it is absolutely necessary that barriers to enrollment in clinical
trials, including possible reimbursement uncertainties or denials, be
eliminated.
ASCO appreciates the opportunity to submit its views on NIH funding
and clinical research. On behalf of oncologists and their patients, we
urge Congress to continue its strong support of NIH. We also recommend
that special attention be paid to the clinical research enterprise to
ensure that basic research findings are promptly brought to the patient
bedside.
______
Prepared Statement of the National Prostate Cancer Coalition
Mr. Chairman and members of the Subcommittee on Labor, Health &
Human Services and Education Appropriations, the National Prostate
Cancer Coalition (NPCC) is a vital organization that includes, on its
board of directors, representatives from the American Foundation for
Urologic Disease, the Cancer Research Institute, CaP CURE, the Huntsman
Cancer Center and Us TOO! International. Other coalition partners
include the American Urological Association, B'nai B'rith International
and Men's Health Network. NPCC supporters are also thousands of
survivors and their families, researchers and health professionals.
Mr. Chairman, the NPCC strongly urges you and your colleagues to
make appropriations to the National Institutes of Health (NIH) and the
National Cancer Institute (NCI) such that $324.4 million will be
available to carry out the fiscal year 2001 commitment to the NIH five-
year investment strategy for prostate cancer research. This funding
will give hope to the nearly 200,000 men who learned they have prostate
cancer in 1999. And it will bring closer the day when the coalition no
longer has to cite the chilling fact that nearly 40,000 American men
lost their lives to prostate cancer last year.
The amount required for NIH is an increase of 15 percent over the
fiscal year 2000 appropriation. We also request full funding of the NCI
director's professional judgment, or ``bypass,'' budget at $4.1
billion.
As you know, the bypass budget goes directly to support badly
needed investigations that will hasten new treatments and cures for
cancer. The 15 percent increase to NIH is necessary to fulfill
Congress's 1998 bipartisan commitment to double the NIH budget within
five years. Reaching that funding target will allow NIH to pursue
research opportunities that will make a difference in the lives of
every family fighting a dread disease, including those facing cancer.
Mr. Chairman, in addition to asking for your support of prostate
cancer research, the men and their families of the NPCC also
congratulate you and the members of this committee. You took a dramatic
step to improve the nation's biomedical research capabilities when you
committed to double the NIH budget between fiscal year 1999 and fiscal
year 2003. Last year, you showed how serious you were when you provided
NIH with about $2.0 billion more than it received in fiscal year 1999.
And you also took specific action on behalf of prostate cancer
research. Your hearing, in June 1999, brought together oncologist
Christopher Logothetis, M.D., Senator Bob Dole, Michael Milken and
Yankees' great Joe Torre to discuss the near-term promises for prostate
cancer research. As a product of that hearing, NIH presented its five
year investment strategy for prostate cancer research, recognizing that
funding in this important area has fallen far short of meeting the
disease's challenges.
Prostate cancer has been the number one diagnosed non-skin cancer
in the country. It has accounted, on average, for 15 percent of all
cancer cases and 15 percent of cancer deaths among men. Yet, until you
and your colleagues acted, an average of only 5 cents of every federal
cancer research dollar had been allocated to find a cure for this
disease.
While recent increases in prostate cancer research funding are
vital, Mr. Chairman, the unfortunate truth is that they still fall far
short of the need--and they alone are not sufficient to fund all of the
most promising paths to treatment and cure. The NPCC's Medical and
Scientific Advisory Committee--which includes some of the nation's
leading prostate cancer researchers and clinicians--has already
identified more than $500 million in promising research that has not
received funding. Missed opportunities cost lives. The NPCC believes we
must accelerate treatment opportunities by providing the resources to
fund all promising research on the horizon.
We have a strong working relationship with NIH and NCI and applaud
the agencies' leadership and their intramural and extramural
researchers for the tremendous work they have done to help prostate
cancer patients and their families. We've worked hard for NIH's five-
year prostate cancer research strategy. But, because we must remain
attuned to opportunities, we must revisit that strategy next year. The
program's budget was based on conservative projections. We believe that
new treatments could be available soon, but they call for rapid
acceleration of commitments to translational and clinical research. We
must end the bottlenecks in drug development to allow agents to move
quickly from the laboratory bench to the patient's bedside and medical
clinics, where they can end the toll that prostate cancer takes on
America's families.
We support NCI's existing innovative programs in translational and
clinical prostate cancer research, particularly its RAID and
QuickTrials projects. We would like to see these expanded--and married
to innovative collaborations among public and private funders and
providers of prostate cancer research. We also appreciate NCI's
commitment to increase the number of prostate cancer Special Programs
of Research Excellence (SPOREs) and other opportunities that mobilize
interdisciplinary research talent and accelerate institutional
collaborations.
Mr. Chairman, I want to conclude by stressing to the committee that
an investment in cancer research really is an investment, one that will
yield dividends both in lives saved and in dollars and cents.
It may seem shocking to think that, in the past five years, more
than one million men in the United States learned they had prostate
cancer. But the real shock is that we've seen just the tip of the
iceberg.
The American population is aging. Between 1996 and 2014, the 76
million members of the baby boom generation--31 percent of our American
population--turn fifty years old. Those born before 1957 are turning
fifty at the rate of one every seven seconds. Because the risk of
cancer increases after this milestone, more and more Americans will
battle cancer--including prostate cancer--in the coming years.
Cancer care already costs this country more than $100 billion
annually. With the graying of the baby boomers, THE MARCH Research Task
Force had estimated, in 1998, that, if unchecked, the cost of cancer
will jump to more than $200 billion within a decade. Even if Congress's
commitment to cancer research continues to grow at its current rate, we
will still be spending 20 times more on care than cure.
In 2000, one American man in every six is at risk of prostate
cancer; one cancer diagnosis in every seven will be prostate cancer;
and one male cancer death in every eight will be prostate cancer. Some
clinicians note that the number of men in their forties and fifties who
are battling prostate cancer is increasing, and they report seeing more
aggressive forms of the disease in younger men.
Mr. Chairman, in the face of these daunting facts and as you
consider the future investments in NIH and NCI research, NPCC asks you
and your colleagues to be mindful of the impact of prostate cancer on
the country as a whole.
While advancing research in these important programs costs federal
dollars, we ask you to remember the greater costs involved in any
further delay to the cure of prostate cancer.
General Norman Schwarzkopf, a very wise military leader and himself
a prostate cancer survivor, recently discussed cancer research in the
context of military strategy. He put the issue this way: ``There always
comes a time when you must get on with the battle. You cannot sit back
and do nothing, because you'll never have perfect intelligence on the
enemy. Base your battle plan on the best information you have and be
ready to modify your strategy and line of attack. The important thing
is just to get on with it.''
Thank you for your consideration.
______
Prepared Statement of the Cancer Leadership Council
The Cancer Leadership Council (CLC) is a forum of national advocacy
organizations addressing public policy issues in cancer. CLC
participants include organizations representing patients and their
caregivers. We are pleased to have this opportunity to submit comments
to the Subcommittee regarding funding for the National Institutes of
Health (NIH), including the National Cancer Institute (NCI). We are
particularly concerned about clinical cancer research and have
recommended special actions that must be taken to protect clinical
research and ensure that basic research findings are rapidly translated
into improved therapies.
fiscal year 2001 nih funding
The CLC commends the Subcommittee for its leadership in securing
substantial increases in funding for NIH in fiscal year 1999 and fiscal
year 2000 and ensuring steady progress toward a goal of doubling the
NIH budget between 1999 and 2003. Because of the commitment of the
Subcommittee to biomedical research, NIH has experienced a period of
predictability and stability in its funding, and the research
enterprise has benefitted greatly.
The CLC wholeheartedly supports increasing NIH funding by 15
percent in fiscal year 2001, a boost that is necessary to ensure
movement toward the year 2003 funding goal. We also urge that Congress
fund the NCI according to the Bypass Budget, or at a level of $4.1
billion. The Bypass Budget outlines promising research opportunities
that could be funded if NCI receives that level of funding. CLC
believes that important cancer research projects are being abandoned
because of funding constraints, and Congress could ensure that good
science is funded if it meets the Bypass Budget funding recommendation.
coverage for clinical trials
In order to move basic research findings to the patient bedside,
they must be tested in clinical trials. The optimal clinical trials
system is one that enrolls patients promptly and tests therapies
rapidly to answer questions about the best possible treatments.
Unfortunately, there are a number of barriers that prevent individuals
from enrolling in trials and therefore slow the clinical trials
process.
CLC and others in the cancer community have worked diligently to
remove barriers to patient enrollment in clinical trials, and our
efforts have focused on guaranteeing that third-party payers reimburse
the routine patient care costs of those enrolled in cancer clinical
trials. In this Congress, we are seeking passage of the Medicare Cancer
Clinical Trials Coverage Act and inclusion of a clinical trials
coverage provision in the Patients' Bill of Rights.
Although Medicare and other third-party payer policies are not in
the jurisdiction of the Subcommittee, they are vitally important to the
health of the clinical research effort. If researchers face obstacles
to enrolling patients in clinical trials due to real or perceived
difficulties in reimbursement, the speed and efficiency of clinical
trials will be adversely affected and the translation of basic research
findings into new therapies will be slowed.
The CLC urges your support for efforts to guarantee third-party
reimbursement for those enrolling in cancer clinical trials. This
coverage is a necessary component of the biomedical research enterprise
and is of utmost concern to cancer patients and their caregivers.
clinical research study section
In the past, CLC has asked the Subcommittee to direct NIH to revise
the peer review process to ensure that cancer clinical research
proposals receive a fair evaluation. Cancer clinical research proposals
have historically been reviewed by basic researchers, and several
advisory groups to the NIH have concluded that this results in
inequitable review of clinical research because basic researchers are
not well versed in clinical research and the challenges associated with
it.
This Subcommittee previously directed NIH to alter its peer review
process, and the NIH finally responded by establishing a Clinical
Oncology Research Special Emphasis Panel. This panel represented a
significant advance because it provided for the review of clinical
cancer research proposals by clinical researchers. Regrettably, the
Center for Scientific Review (CSR) has indicated that it will
reinstitute a system in which basic researchers will review clinical
research. We urge you to direct the NIH to retain the Special Emphasis
Panel and abandon plans for a system in which cancer clinical research
will again be reviewed by basic researchers.
The CLC is pleased to have the opportunity to submit comments to
the Subcommittee. This panel's steadfast advocacy for biomedical
research is very important to the CLC, and we lend our enthusiastic
support to your efforts to enhance NIH funding. We request your special
consideration of our proposals to protect and foster clinical cancer
research.
Cancer Leadership Council
Alliance for Lung Cancer Advocacy, Support, and Education, American
Cancer Society, American Society of Clinical Oncology, Cancer Care,
Inc., Cancer Research Foundation of America, The Children's Cause,
Inc., Cure For Lymphoma Foundation, Coalition of National Cancer
Cooperative Groups, Inc., Colorectal Cancer Network Kidney Cancer
Association, The Leukemia & Lymphoma Society, Multiple Myeloma Research
Foundation, National Coalition for Cancer Survivorship, National
Patient Advocate Foundation, National Prostate Cancer Coalition, North
American Brain Tumor Coalition, Oncology Nursing Society, Ovarian
Cancer National Alliance, The Susan G. Komen Breast Cancer Foundation,
US-TOO International, Inc., and Y-ME National Breast Cancer
Organization.
______
Prepared Statement of the Lymphoma Research Foundation
Chairman Specter and Members of the Subcommittee: My name is Neil
Ruzic and I have lymphoma, cancer of the lymph system. So do 600,000
other Americans. This country is suffering a lymphoma epidemic. The
incidence of lymphoma is increasing the second fastest of all cancers,
the fastest of cancers that cannot be prevented. That is, unlike
melanoma (the fastest growing) and unlike lung cancer, you can't
prevent lymphoma by staying out of the sun or stopping smoking. The
cause is unknown.
Another 87,000 or more Americans will contract lymphoma this year.
Our children are getting it--60 percent of childhood cancers are
lymphoma or the related disease of leukemia. Our men are dying from
it--lymphoma is the fourth leading cause of death by cancer. Our women
are dying from it at almost the same rate.
The Lymphoma Research Foundation of America does what it can to
help these people. It funds research projects mostly of young PhD or MD
scientists. It is the nation's primary organization dedicated to
providing information and support to lymphoma patients and their
families. On behalf of the Lymphoma Research Foundation, I want to
thank Chairman Specter, Ranking Member Harkin and the Subcommittee for
being instrumental in the NCI's convening a Progress Review Group on
lymphoma later this year. Panels of prominent scientists will review
NCI's lymphoma research portfolio and recommend a plan of action that
will speed progress, helping ensure that limited resources are used
optimally. These are important steps . . . but there could be more.
A year and a half ago, following surgery to remove my spleen that
had grown four times too large, I was diagnosed with mantle cell
lymphoma. This is the deadliest of the lymphomas, whose victims have an
average time from diagnosis to death of three years. Despite the lack
of a cure, oncologists at five leading institutions advised me to take
aggressive chemotherapy. Nothing else, they said at the end of 1998,
was proved and ``probably would not work.'' They admitted that chemo
would only ``buy time,'' and in the long-run--if there was one--would
work for shorter and shorter times until it destroyed my immune system.
Instead of taking chemotherapy, I immediately stopped the book I
was working on and devoted my time to learning about lymphoma by
reading scientific papers and visiting the nation's medical research
centers. After 18 months of looking, I can tell you that the cures are
there, in the brains and experiments of the medical researchers. These
discoveries are in their infancies and require much more research and
testing, but they are there--right now--in the laboratories of the
United States.
I am one of the lucky ones, at least so far. Without treatment of
any kind, my lymphoma for unknown reasons not only remains indolent but
seems to be subsiding. That is, the lymph nodes or glands in my
abdomen, once the size of golf balls, now are the size of grapes, and
some have shrunk to normal size (the size of a pea.) I am not sick. I
have no symptoms. Why?
I approached a team of creative gene researchers at UCLA, and
together with the Lymphoma Research Foundation and the Mantle Cell
Group (an e-mail information assembly of patients), sponsored a project
to try to answer that question. The idea was that if we could render
lymphoma quiescent, or indolent, it would be almost as good as finding
a cure. The project, now underway, is a small part of the sudden
revolution in genetics and molecular biology. New therapies are being
tested every day, even faster than the completion of the human genome
project, which already is of enormous benefit to cancer research.
There are good scientific reasons why funding should be increased
immensely for lymphoma research. Lymphoma is to the lymph system what
leukemia is to the blood system. The liquid lymph contains white blood
cells that produce antibodies which, in turn, fight infection and
filter out pathogens. Because lymph cells move freely between the lymph
and blood systems, an actual and comprehensive cure for lymphoma must
begin with a basic understanding not only of the interplay between
these systems but also of how the immune system works, how the
chromosomes and genes function, how the very molecules of the cells
work together. Because of this systemic nature of lymphoma, any actual
cure would be applicable to lung, colon, breast, prostate, and other
kinds of cancer.
As important as is the study of lymphoma to curing all cancers,
lymphoma research constitutes a mere 2.2 percent of the budget of the
National Cancer Institute! And the NCI's budget for all cancer
research, even now that it has been increased, is only $3.3 billion.
That satisfaction with the status quo is wrong when human lives are
at stake. For the first time in history, lymphoma and other hopeless
diseases are suddenly and uniquely vulnerable to a massive, coordinated
attack by government and university laboratories. There has never been
a better time than right now.
Significant breakthroughs in previously unrelated fields of
engineering, chemistry, biology, and physics have been quietly
maturing--remarkably at the same time--and everything at last is
finally coming together. Computer technology, for instance, finally has
merged with gene engineering so that we actually can put DNA on a
microchip and isolate genes that are broken, or determine the pathways
of genes responsible for specific diseases.
Common wisdom says that cancer is not just one, but hundreds of
diseases--lymphoma, leukemia, lung, breast, prostate and other organ
cancers, and so on--leading you to believe that curing cancer requires
an equal number of hundreds of different approaches. That assumption is
no longer true. All cancers have in common uncontrolled cell growth,
and for that to occur a series of mutations in the genes which control
cell growth and behavior must take place. Tremendous progress in the
understanding and manipulation of genes has been made in just the past
year or so.
Yet genetics researchers such as Dr. Jonathan Braun, Dr. Phillip
Koeffler, and their teams at UCLA, who are at the front lines in this
battle, lack funds for a truly large expansion of their programs and
can test only a small number of their ideas. Typically these labs
employ 10 to 20 scientists and technicians. They could expand to 100 or
200 workers, effectively, without wasted effort, and thereby hasten the
research payoff .
A novel approach pioneered by Dr. Judah Folkman at Children's
Hospital in Boston that stops angiogenesis or ``blood growth'' that
feeds tumors has caused scores of new compounds to be tried. Dr.
Parkash Gill and his group at the University of Southern California,
for instance, have found ways to alter the genes to cut off tumor blood
supply. These researchers and others at Northwestern University have
wiped out cancer in near-death patients who have had metastasized
cancers all over their bodies. But Dr. Gill, chronically underfunded,
lacks the means to pursue all but a few animal studies. Like others in
small labs, he must take valuable research time to seek the funding he
needs. (The average project leader in this field spends a third of his
research time writing proposals or otherwise seeking grants.)
As new therapies begin to replace outmoded, often-harmful
chemotherapies, we must speed up testing and clinical trials of other
techniques, even as the more fundamental, ultimate, solutions such as
gene therapy are being refined. For instance, antibodies made from
human cells and cloned to produce large numbers of them now are
targeted to kill cancer cells specifically, instead of killing all
cells that grow, normal or diseased (as does chemotherapy.) These
monoclonal antibodies also are being combined with radioisotopes to be
even more effective.
Another new technique applicable to all cancers is the stimulation
of the body's own ``T cells,'' our immune system's most effective
killers of viruses, bacteria, and parasites. The problem is that cancer
cells have evolved mechanisms to hide themselves from T cells. It's
like having an Air Force armed with one-ton bombs ready to destroy an
army of invaders but not bombing the enemy troops because you can't
find them. Dr. Carl June and co-workers at the University of
Pennsylvania have discovered that by stimulating two different
receptors they can get the T cells to launch an immune response. In
fact, the T cells are so sensitive to co-stimulation they also secrete
chemical messengers that work to make even more T cells. Now not only
can we use those one-ton bombs, but they are multiplied! This project
has received private funding from many sources, including the author's.
But with the massive governmental spending increase envisioned here,
other labs could replicate the results and help push it to the hilt.
Vaccines--not to prevent but to cure--are being grown from
patients' tumors and customized to kill lymphomas in those lucky enough
to get into the right protocol. Human trials run by such pioneers as
Dr. Ronald Levy at Stanford and Drs. Larry Kwak and Wyndham Wilson at
the NCI include only hundreds instead of hundreds of thousands of
cancer patients.
Most of these and other potential new cures began with research
into lymphoma, but they are applicable to all cancers!
In addition there are the important basic research projects of
hundreds of bright, mostly young medical scientists which have had to
shut down before hardly getting started for lack of funding.
Individuals and foundations contribute at least as much as the
government, but most of those funds go for education and prevention.
Pharmaceutical companies add another $4.8 billion annually for
research--almost double that of the government--but little of this sum
is spent on untargeted basic research
The 10,000 universities in this country are among America's
greatest assets. Let's use them to the hilt. These institutions not
only educate the brightest of our young men and women but also attract
the best foreign students who earn advanced degrees and often stay to
work in the U.S. All graduate students in science do basic research. It
is this constant probing into fundamental knowledge in molecular and
even atomic biology, immunology, genetics, and into even seemingly
unrelated research in bioengineering, chemistry, and computer
technology that will cure cancer. The research freedom at the
universities and peer reviews to decide on worthy ideas are good
practices that should not be changed. Instead, the government should
seek opportunities to expand the existing system and infrastructure
massively.
The key question is whether the new money could be spent profitably
so that real cancer cures will be in use in ten years. Here are five
spending steps that occur to me, which I am sure can be improved upon
by university and NCI scientists:
Massively increase funding for non-targeted basic research, using
the majority of the funds.--Here are two examples of how basic
research, which when undertaken was not directed toward curing any
specific disease, but now is leading to specific cancer-fighting
studies: The 1953 discovery that earned the Nobel Prize for Watson and
Crick, showing that the double helix shape of DNA contained subunits of
nucleotides, led directly to the current sequencing of more than
100,000 genes on our 23 pairs of chromosomes. Dr. Gunter Blobel of New
York's Rockefeller University recently was awarded a Nobel Prize for
his discoveries into how proteins locate themselves in cells and how
environmental mutations in the process lead to disease.
Ask every university cancer project leader which of them could gear
up to handle-effectively and efficiently--10 or 20 times their present
funding.--If their answers make sense, fund them. That may not be the
most cost-effective method of funding in the short run, but any money
wasted on the way to the greater goal will pale in comparison to the
overwhelming financial benefit of a cancer-free economy. We can not
afford to let research funding remain a zero-sum game where spending
additional money on, for instance, breast cancer, detracts from, say,
lymphoma research.
Proselytize young people into following scientific careers in
medicine, medical engineering, immunology, genetics, and related
fields, both at the professional and technical-support level.--Yes,
education takes time. But these new people will be needed in the
massive fight against cancer, and the sooner they start the sooner they
will contribute. We should offer full economic assistance for students
to enter such careers, and for graduate students to earn combined MD
and PhD degrees. Such funding will relieve professors from having to
pay their graduate students out of their research grants, thereby also
making them more productive. Such a program should be publicized widely
to attract the most creative people from throughout the world.
Create a dozen more big cancer centers of excellence throughout the
country, letting the universities compete for the new sites.--Encourage
competition by funding post-doctoral researchers and by endowing chairs
in medical research laboratories. It is through competition, the engine
of progress, that enormous goals are realized. Biotechnology is the
``dot com'' of the new decade. The U.S. has benefited profoundly from
the internet change relative to other countries because of the
technological infrastructure already in place. Intensifying the
infrastructure and career development in bioscience for cancer
breakthroughs is a role that government plays well, and industry does
not.
Coordinate the research results of the NCI, universities, and
others by instituting a worldwide central data base and ultrafast
communications system.--The recent inauguration of PubMed Central and
the database of the National Library of Medicine are welcome steps, but
the effort is still terribly underfunded. Researchers need to be
informed instantly of discoveries elsewhere that may bear upon their
work. One can picture a thousand information experts at their computers
alerting university researchers to meaningful experiments. It is
important that the government avoid playing the role of director of
this War on Cancer; the government should be the coordinator.
If, in providing for such an expansion, the Congress voted for a
dramatic and immediate increase for the NCI of some $30 billion--with
the majority of the money going for basic research--the returns would
begin to pour in almost right away. They would build to a flood in a
few years. They would race to a crescendo by the end of the decade.
Is it worth the money?
Yes, in terms of misery and death avoided. Yes again, in economic
terms. The annual cost of cancer to the U.S. alone currently is $107
billion, including direct and indirect costs. According to economists
Kevin Murphy and Robert Topel at the University of Chicago, if all
forms of cancer were eliminated the economic value to the United States
would be $46.5 trillion, which is more than all U.S. assets! The
economic and humanitarian benefit to other nations also would be
overwhelming. What a fantastic tool of foreign policy, the exportation
to other countries of the cure for cancer!
Elimination of death by cancer would usher in a new era of
worldwide health and prosperity, removing misery, and rendering human
life more productive and happier. Progress in the various sciences is
rushing steadily toward the cure of cancer. From the viewpoint of
government appropriations, whether that cure arrives in ten years or in
fifty years, or somewhere in-between, is only a matter of money.
______
Prepared Statement of the National Nutritional Foods Association
Mr. Chairman and Members of the Subcommittee: Thank you for the
opportunity to present public witness testimony on behalf of the
National Nutritional Foods Association (NNFA). My name is Patrick
Toomey. I am President of NNFA, a trade association representing 3,000
independent health food stores and 1,000 manufacturers, distributors
and suppliers of natural health products, including organic and natural
foods, natural ingredient cosmetics and dietary supplements.
In addition to being the President of NNFA, I also own a small
natural foods store, Toomey's Natural Foods in Milford, Ohio. I have
been an industry retailer for 25 years and for the past ten years I
have served on both national and regional boards of the NNFA.
congressional mandate mirrors citizen demand
National interest in access to reliable information on safe and
effective vitamins, minerals, herbs, amino acids and other dietary
supplements has grown steadily since the Dietary Supplement Health and
Education Act (DSHEA) unanimously passed the House and Senate to become
the law of the land in 1994.
Approximately 158,000,000 Americans are taking dietary supplements,
spending, by some estimates, as much as $14.5 billion a year in health
food stores alone. Americans are looking to safe, natural alternatives
to prescription drugs to treat and prevent disease, and to maintain
good health by supplementing inadequate diets with vitamins and
minerals.
nutrients can prevent chronic disease
We are entering a new era of recognition of the value of natural
pathways to good health. For example, the Food and Nutrition Board of
the National Academy of Sciences, which devises Recommended Daily
Allowances (RDAs) for nutrients for the Food and Drug Administration,
has issued the first of a series of reports presenting revised nutrient
intake guidelines. Originally introduced in 1941, RDAs were intended to
prevent classical nutrient deficiency diseases nearly extinct in the
U.S. today, such as scurvy, beriberi and rickets. Now, these reports
are revising and expanding RDAs to reflect compelling evidence, which
supports the use of nutrients to help prevent chronic disease, such as
osteoporosis. We agree with the Chairman of the Food and Nutrition
Board, who characterized this approach as ``. . . a major leap forward
in nutrition science.''
Similarly, the report of the President's Commission on Dietary
Supplement Labels endorsed continued research on the benefits of
dietary supplements in health promotion and disease prevention. The
Commission hailed the increasing research-based documentation of the
benefits of dietary supplements in maintaining health and preventing
chronic disease and other health-related conditions, and called for
continuation of this welcome trend. NNFA continues to endorse the
Commission's recommendation that, ``. . . the public interest would be
served by more research that assesses the relationships between dietary
supplements and maintenance of health and/or prevention of disease.''
herbs and botanicals are beneficial and cost-effective
In addition to supporting these kinds of exciting new findings on
the health benefits of nutrients, NNFA urges the Committee to continue
to support research on medicinal herbs and botanicals, also classified
as dietary supplements under the DSHEA. The results of a study on
ginkgo biloba, published recently in the October 22, 1997 Journal of
the American Medical Association, indicates that administration of this
herbal extract, recognized for centuries in Chinese medicine for its
ability to stimulate and improve blood circulation in the brain, could
delay the onset of Alzheimer's Disease for up to six months. This could
represent tremendous savings of lives and dollars from a disease, which
costs society approximately $90 billion a year. Other studies show saw
palmetto more effective than prescription medicine at reducing benign
prostate enlargement, with far less expense and no reportable side
effects. In 1998, Harvard University completed a 14-year study of
80,000 nurses, concluding that large amounts of vitamin B6 and folic
acid could prevent heart attacks by an astounding 51 percent.
Millions of Americans are turning daily to herbal remedies and
seeking primary health care from the alternative, holistic providers
who prescribe them. There is an urgent need for a dramatic increase in
support for research on herbs and botanicals, justified by consumer
demand and the Congressional intent expressed in DSHEA. The Dietary
Supplement Commission report recommends that, ``. . . Federal agencies
continue to support off research on the health benefits and safety of
dietary supplements. Research should be expanded beyond the
traditionally supported areas associated with vitamin and mineral
supplements and include research on some of the more promising
botanical products used as dietary supplements.'' NNFA whole-heartedly
agrees.
Ours is one of the few cultures in the world for whom the
prevention and treatment of disease with non-prescription herbal
medicines is the exception rather than the rule. This is largely due to
the fact that foreign research oftentimes is deemed unacceptable by the
Food and Drug Administration for use in justifying health claims for
herbs and botanicals. We urge the Committee to provide the adequate
funding for research on the safety and benefits of medicinal herbs.
nih's office of dietary supplements
The Office of Dietary Supplements (ODS) was established at the
National Institutes of Health by DSHEA, to stimulate, coordinate and
disseminate the results of research on the benefits and safety of
dietary supplements in the treatment and prevention of chronic disease.
It is my understanding that ODS will receive its authorized level of $5
million for fiscal 2000. NNFA requests a further increase for this
office in fiscal 2001.
NNFA agrees with the President's Commission on Dietary Supplement
Labels that if fully-funded, `` . . . ODS could play a valuable role in
providing consumers with information about dietary supplements . . .
including [the] promotion of scientific studies on potential roles of
dietary supplements in health promotion and disease prevention.
Appropriations as authorized by DSHEA are essential if ODS is to meet
[the] mandates of the Act.'' ODS now has the capacity to provide useful
information to consumers whereby meeting the Congressional mandate of
the Office.
We also urge continued funding for the botanical research
initiative which began in fiscal 1999 at the ODS. ODS has recently
funded two botanical research centers located at the University of
California at Los Angeles (UCLA) and the University of Illinois at
Chicago (UIC). ODS expanded the botanical research center initiative by
releasing an additional request for application for a botanical
research center at the end of 1999. ODS' long-term goal is to expand
the initiative and obtain botanical research centers throughout the
country. NNFA supports this goal.
national center for complimentary and alternative medicine
In 1992 Congress directed the National Institutes of Health to
establish the Office of Alternative Medicine with the expressed task of
assuring objective, rigorous review of alternative therapies to provide
consumers reliable information. In fiscal 1999 the Office of
Alternative Medicine was elevated to a Center with its own grant making
capabilities. Funding for the Center has grown along with its increased
authority from $2 million in fiscal 1992 to $50 million in fiscal 1999
to $68.8 million in fiscal 2000. I thank the Committee for its support
of NCCAM. NNFA supports increased funding for this important Center in
fiscal 2001. This has given alternative research a well-deserved boost
and is more in line with the health choices of most Americans.
A 1998 Newsweek study states that some 83 millions Americans, about
40 percent of the adult population, are seeking alternative medical
treatment. Also, findings from the ``National Survey of Alternative
Medicine Use,'' published in the January, 1993 New England Journal of
Medicine, reveal that Americans made an estimated 425 million visits to
alternative medical therapy providers in 1990, exceeding the 338
million visits made to all U.S. primary care providers that year. The
survey also showed that out-of-pocket expenditures associated with
alternative therapies totaled $10.3 billion in 1990, approaching the
$12.8 billion in out-of-pocket expenses incurred for all U.S.
hospitalizations during the same period. It is crucial for the health
and security of all Americans that objective, scientific research is
done to determine the effectiveness of complementary and alternative
therapies.
demonstration projects at ahrq and hfca
The Agency for Healthcare Research and Quality (AHRQ) is often
directed by the Committee to pursue projects designed to research the
cost-effectiveness attendant to novel approaches to the treatment and/
or prevention of illness. The time is right for investigation of the
worthiness of certain dietary supplements, based on well-designed,
cost-effectiveness research.
Every year, treatment of chronic conditions and illnesses--from
flus and colds to hypertension to dementia and Alzheimer's disease--
generates enormous publicly and privately funded health care
expenditures. There exists an opportunity to trim such burgeoning costs
through prevention and/or treatment of these chronic ailments--or delay
of their onset--with safe, effective, low cost dietary supplements.
NNFA is confident that basic research at NIH can lead to appropriately
structured, cost/outcome research at AHRQ which would demonstrate the
value of dietary supplements in comparison to contemporary medical
intervention. This evidence can, in turn, lead to Health Care Financing
Administration (HCFA) projects to determine if a policy of
reimbursement could be established.
Despite the growing popularity and demand for herbs and nutritional
supplements, and their widespread use for prevention and intervention
of chronic illness, precious few large-scale outcome studies on
American populations are available to give health professionals the
information they need to make decisions on alternatives to contemporary
medical approaches. Echinacea has been shown to be effective in
preventing and treating colds and flus; folic acid has been shown
effective for neural tube defects and also homocysteine levels in
cardiovascular disease; herbal/nutritional combinations have been shown
to provide control for hypertension without the side effects which
cause many patients to stop using their prescription medicine; and the
use of glucosamine sulfate for joint function. NNFA believes that a
sufficient body of botanical and nutrient research may exist in certain
instances, to whet AHRQ's appetite and to warrant Congressional
consideration of cost-effectiveness studies in this area.
NNFA urges the Committee to consider directing AHRQ to work with
the Office of Dietary Supplements and the National Center of
Complimentary and Alternative Medicine to review the existing outcome
research on dietary supplements. The AHRQ could then investigate the
feasibility, under appropriate protocols, of developing cost-
effectiveness projects designed to compare the value of herbs and other
dietary supplements in the treatment and prevention of chronic illness
to typical medical approaches. The areas I have mentioned are but a few
of the many possibilities which urgently present themselves for
research and evaluation. Once the necessary biomedical and cost-
effectiveness research have been completed, NNFA urges the Committee to
direct HCFA to investigate the potential reimbursement for promising
alternative therapies and treatments involving nutritional supplements
and herbs.
a sound investment in the health and well-being of all americans
Science and experience ably demonstrate a wealth of benefits
attendant to the regular use of vitamins, minerals, amino acids,
enzymes, herbs and botanicals--all classified by DSHEA as dietary
supplements. Dietary supplements are allowing millions of American
consumers to take charge of their own good health by safely and
effectively preventing and treating a host of illnesses and conditions.
The body of research supporting use of these products is impressive,
but sorely requires immediate and dramatic expansion. NNFA urges the
Committee to endure the Congressional mandate expressed in DSHEA by
investing in the scientific research which holds the key to our
knowledge of the remarkable importance and value of dietary
supplements.
Thank you.
______
Prepared Statement of the NYU School of Medicine
I want to begin by thanking you, Mr. Chairman, and members of this
Subcommittee for your continued support of the National Institutes of
Health (NIH). You clearly recognize the importance of a strong Federal
investment in medical research and that today's investments may
represent tomorrow's treatment and cures for many disorders and
diseases. This Subcommittee has been a leader in ensuring that our
nation remains a leader in the field of medical research, and on behalf
of the NYU School of Medicine, I thank you.
The NYU School of Medicine takes pride in a history that goes back
to 1837 and includes the initiation of and the participation in many of
the major events in American medicine through two centuries. The School
annually graduates 150 physicians, and it employs 3,000 individuals
including more than 800 faculty members. For 150 years the School has
provided high quality patient medical services and medical supervision
to Bellevue Hospital Center, New York City's premiere municipal
hospital. The mission of the School is threefold: the training of
physicians, the search for new knowledge, and the care of the sick.
These three missions must be carried out simultaneously for they are
wholly dependent upon each other, not only for inspiration, but for
their very means of success. At the School of Medicine, we recognize
that in order to excel in these three missions, we must be responsive
to the major events and trends that are shaping medicine in our time.
These include: the revolution in molecular biology and medical
technology; the societal imperatives imposed by rising health care
expectations and the finite limits on resources; the explosive growth
in biomedical information; and the increasing role of the patient in
the decision-making process.
In my opinion, there has never been a more exciting time to enter
medicine. Enormous breakthroughs have allowed great advances in our
understanding of disease and our ability to devise new therapies. We
know with certainty that this explosion of knowledge will continue.
With continued federal support for basic, cutting edge research
supported through the NIH, we will continue to move closer to our goal
of translating the promise of scientific discovery into an improved
quality of life for all Americans. As we enter this century, we must
continue to provide the resources and investments necessary to seize
upon these tremendous opportunities. The NYU School of Medicine
supports the recommendation of the Ad Hoc Group for Medical Research
Funding, a coalition of nearly 200 patient and voluntary health groups,
medical and scientific societies, academic and research organizations,
and industry, of $20.5 billion for NIH in fiscal year 2001. This $2.7
billion (15 percent) increase represents the third step toward
fulfilling the bipartisan goal of doubling the NIH budget by fiscal
year 2003.
As the volume of NIH research increases, we must address the need
for upgraded, state-of-the-art facilities to carry out this federally-
supported biomedical and behavioral research. A 1998 National Science
Foundation (NSF) study on the status of scientific research facilities
at U.S. colleges and universities identified an estimated $11.4 billion
in deferred research construction and repair/renovation projects, as
well as a decrease in new construction of health research facilities
across an array of institutions. Adequate laboratory space and research
instrumentation are necessary to obtain the best data from NIH research
dollars. For this reason, I urge you to provide $250 million for
extramural facilities construction at the National Institutes of Health
(NIH) in your fiscal year 2001 bill.
In addition to providing significant funding increases for NIH--
including increased funds for extramural research infrastructure--I
thank you for raising the salary cap imposed on extramural researchers
from Executive Level III to Executive Level II ($141,000) in last
year's bill. The higher salary level will allow many institutions, such
as the NYU School of Medicine, to attract and retain the best
investigators in their respective academic research programs. However,
under the Senior Biomedical Research Service (SBRS) program on the NIH
campus, the NIH can pay its senior investigators up to $151,000--
roughly equal to what the salary cap on academic researchers would be
if it were indexed for inflationary increases over the past decade. To
seek a level playing field with intramural NIH researchers, we seek
your support in raising the current salary cap to Executive Level I in
the fiscal year 2001 bill.
Over the past decade, several trends in the health care marketplace
and fiscal stewardship of the public-private partnership have
destabilized research institutions and the pool of specially trained
personnel necessary to continue to push the frontiers of medical
research. For this reason, the medical center supports the proposal
that the NIH establish a Flexible Institutional Support for Health
Research (FISHR) program. This peer-reviewed, three-year grant program
will provide institutional resources to meet evolving needs in research
in the range of $25,000 to $300,000 a year for deans of medical, public
health, nursing and dental schools. We suggest a funding level of $60
million in fiscal year 2001 for this competitive, renewable pool of
accountable resources which will help modify the impact of the recent
stresses experienced by research and academic institutions and will
serve to maintain the integrity of our national research enterprise.
I would like to highlight an exciting initiative at the School of
Medicine. The School of Medicine is developing a comprehensive Program
in Women's Cancer (PWC). This program will be an integral component of
the Comprehensive Cancer Center (CCC). The PWC will encompass the full
spectrum of clinical services, advanced training, fundamental and
translational research into those cancers that exclusively or primarily
affect the female reproductive tract. The components of this program
include: etiology and biology; risk identification and prevention;
screening; diagnosis and treatment; palliation and rehabilitation; and
psycho-social support.
The PWC will function as a multi-departmental entity with on-site
clinical services provided by the Departments of Medicine, Obstetrics
and Gynecology (Ob/Gyn), Pathology, Radiation Oncology, Radiology, and
Surgery. The physicians from these departments will be supported by a
team of social workers, physical and occupational therapists to ensure
continuity between in-patient and out-patient care.
The School is seeking the Subcommittee's support to expand its PWC.
The School is requesting $5 million in support through the Health
Resources and Services Administration's Health Facilities Construction
account in your fiscal year 2001 bill.
Thank you again, Chairman Specter, for your attention to these
important issues.
______
Prepared Statement of the Texas Neurofibromatosis Foundation
The Texas Neurofibromatosis Foundation is pleased to submit
testimony in support of funding for the National Institutes of Health
and for neurofibromatosis in your fiscal year 2001 bill.
The Texas Neurofibromatosis Foundation was established in 1981 and
is committed to meeting the needs of people challenged with NF by
providing care, comfort, support, information, education, funding, and
other resources for the treatment, prevention, and eventual cure of
this disease. With offices in Dallas and Houston, the Foundation
coordinates support groups, organizes fundraising events and
educational symposiums, and assists with NF clinics across the state
that serve the more than 5,000 individuals with NF in Texas. Dedicated
volunteers form the heart of the organization, giving their time and
talents to increase public awareness and raise the money necessary to
support patient programs and research projects. Advocates from around
the country look to the Texas NF Foundation as a model when
establishing new a NF organization in a state. Texas is also home to
some of the most exciting NF research described below.
NF, incorrectly but commonly known as elephant man disease,
involves the uncontrolled growth of tumors along the nervous system
which can result in terrible disfigurement, deformity, deafness,
blindness, brain tumors, cancer and/or death. It is the most common
neurological disorder caused by a single gene. While not all NF
patients, like myself, suffer from the most severe symptoms, all of us
live our lives with the uncertainty of not knowing whether we too will
be severely affected because NF is a highly variable and progressive
disease. Approximately 100,000 Americans have NF, and it appears in
approximately one in every 3,500 births. It strikes worldwide, without
regard to gender, race or ethnicity. There are two types of NF; type 1,
which is the more common of the two and NF2 which primarily involves
acoustic neuromas causing deafness and balance problems as well as
other types of tumors such as schwannomas and meningiomas.
With your continued support and a relatively small Federal
investment, NF has become one of the great success stories in the
current revolution in molecular genetics. Because of the enormous
advances that have been made, one leading NF researcher has stated that
more is known about NF genetically than any other disease. Accordingly,
many NF researchers believe that NF should serve as a model to study
all diseases. The future promise of NF research is based upon these
successes. Let me highlight for you some of the advances in NF research
that have occurred since 1990:
--The discovery of the NF1 and NF2 genes and gene products;
--Determination of the close connection between NF and cancer, brain
tumors, learning disabilities, heart disease, and other
neurological disorders;
--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;
--Development of advanced animal models;
--Development of drug and gene therapies;
--Commencement of clinical trials at NCI;
--Establishment of an international consortium of NF researchers and
patients;
--Rescuing learning deficits in animal models with NF1;
--Substantial increase in the number of NF researchers
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 five Institutes at NIH are currently supporting NF
research (NCI, NINDS, NIDCD, NICHD, and NHLBI) and NIH's total NF
research portfolio has increased from $11 million in 1995 to
approximately $18 million in 2000. The National Institute on Disability
Research and Rehabilitation (NIDRR) within the Department of Education
has also expressed an interest in pursuing NF research in the learning
disability area since 35-60 percent of children with NF suffer from
learning disabilities. For fiscal year 2001, the Subcommittee's
continued support will be critical to build upon the basic and clinical
research described below which is essential to moving us closer to a
treatment and cure for this disease.
Since the discovery of the NF gene, researchers have established
the connection between NF and the following diseases and disorders:
Cancer.--Dr. Samuel Broder, former Director of the National Cancer
Institute, stated that NF was at the ``cutting edge'' of cancer
research. Studies have investigated the connection between the ras
oncogene, which is critical to control growth and development in
healthy cells (and when mutated contributes to the formation of
tumors), and the NF1 gene which is a tumor suppressor. The studies
showed that ras activity can be inhibited by the NF1 protein
neurofibromin. Since elevated ras activity is involved in 30 percent of
all cancers, the inhibition of ras by neurofibromin may result in a
cure, not only for NF, but also for many of the most common forms of
cancer.
Learning disabilities.--In addition to NF's connection to cancer,
NF also provides a unique opportunity to begin to uncover a molecular
basis for cognitive impairment, and it holds the prospect of possessing
a radiologic marker for brain dysfunction. Specific learning
disabilities are the most common neurological complication in children
with NF1. The reported frequency of learning disabilities in children
with NF ranges between 30-65 percent. Uncovering the molecular and
cellular causes for the learning deficits caused by NF should also
reveal important clues on what causes and how to cure tumors in NF1
patients, because the same molecular mechanisms underlie both tumor
formation and learning disabilities. For example, recent research on
mice with the same mutation that causes NF1 in humans (NF1 mice) has
shown that treating the mice with a drug (farnesyl transferase
inhibitor) that decreases ras function (the same ras that causes cancer
and tumors) CURES their learning disabilities. Studies on fruit flies
have also demonstrated that the protein made by the NF1 gene is part of
the c-AMP pathway, the pathway which is known to control learning and
memory.
Deafness.--Leading NF researchers believe that the science has
progressed to the point when a gene therapy for NF2 can be developed
and tested. Unlike other genetic forms of deafness, in which 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. 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.
Heart disease.--Recently published research has also demonstrated
the relationship between NF and 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 which causes cancer and
learning disabilities also causes heart valves to close and
neurofibromin suppresses ras, thus opening up the heart valve. Errors
in valve formation account for a large percentage of congenital heart
disease in humans, and congenital heart disease is the most common type
of congenital defect. 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. This finding opens up a new area for future research in
congenital heart disease. In addition, the role of NF1 in neural tube
closure suggests that NF1 research may bear on the understanding of
causes of Spina Bifida, a common birth defect.
NF research is on the precipice of many major discoveries that will
have broad and significant implications for Americans suffering from
many disorders and diseases. For example, NCI is currently conducting
clinical trials on NF patients involving the use of farnesyl
transferase inhibitors in pediatric patients with refractory solid
tumors. Other areas of research opportunity include:
--Further clinical trials;
--Expansion of drug and genetic therapies for NF and related
disorders;
--Further development of NF animal models;
--Maintenance and expansion of consortium of NF clinical researchers
and patients;
--Further determination of the connection between NF and cancer,
tumors, heart disease, learning disabilities, deafness, bone
and other disorders;
--Further determine function of the NF genes and gene products;
--Expansion of pool of NF researchers
This Subcommittee recognizes that our goal should be to translate
the promise of scientific discovery into an improved quality of life
for all Americans. To accomplish this goal, we must, as a nation,
continue to invest in medical research at the NIH. Sustained, stable
growth in funding for the NIH is needed to build upon past scientific
achievements, address present medical needs, and anticipate future
health challenges. Volatility and dramatic fluctuations in funding can
be as harmful to the research enterprise as inadequate growth. Towards
this end, I encourage the Subcommittee to support the recommendation of
the Ad Hoc Group for Medical Research Funding, a coalition of over 200
patient and voluntary health groups, medical and scientific societies,
academic and research organizations, and industry, which calls for a
fiscal year 2001 appropriation of $20.5 billion for the National
Institutes of Health (NIH). In addition to providing increased funding
for the NIH as a whole, this Subcommittee has recognized the promise of
NF research and has included language in your fiscal year 2000 Report
encouraging NCI, NINDS, NICHD, NIDCD, NHLBI, and NIDRR at the
Department of Education to increase their NF research portfolios
through the use of: Requests for Applications, Program Announcements,
the National Cooperative Drug Discovery Group Program, and Small
Business Innovation Research Grants, as appropriate. I urge the
Subcommittee to continue to encourage these Institutes to continue this
trend.
In closing, I will end with a statement that appeared in an edition
of Cold Spring Harbor Laboratory's newsletter which focused on major
breakthroughs in NF research: ``the hope is that the day may come when
doctors can flip critical switches to repair the broken circuits in
each of these disorders and diseases. Such life-changing therapies will
be the reward for years of enthusiastic basic research.'' I believe,
Mr. Chairman and members of the Subcommittee, that with your continued
support, that day will soon be here.
______
Prepared Statement of the Wake Forest University Baptist Medical Center
I would like to begin by thanking the members of this Subcommittee
for their continuous support of and tireless efforts to increase
funding at the National Institutes of Health. You have all been leaders
in helping to advance science to ensure that today's discoveries
translate into tomorrow's treatments and cures for millions of
Americans. Your leadership has also helped to ensure that America
remains a leader in the field of medical research. The Wake Forest
University Baptist Medical Center stands behind your goal of doubling
the budget of the National Institutes of Health (NIH) by the year 2003.
As you have stated so eloquently many times, Chairman Porter, there are
more opportunities in basic and clinical research than ever before. And
as we enter this century, we must provide the resources and investments
necessary to seize upon these opportunities. The medical center
supports the Ad Hoc Group for Medical Research Funding's fiscal year
2001 request of $20.5 billion for NIH. This $2.7 (15 percent) increase
represents the third step toward fulfilling the bipartisan goal of
doubling the NIH budget by fiscal year 2003.
As the volume of NIH research increases, we must also recognize the
need for upgraded, state-of-the-art facilities to carry out this
federally-supported biomedical and behavioral research. A 1998 National
Science Foundation (NSF) study on the status of scientific research
facilities at U.S. colleges and universities identified an estimated
$11.4 billion in deferred research construction and repair/renovation
projects, as well as a decrease in new construction of health research
facilities across an array of institutions. Adequate laboratory space
and research instrumentation are necessary to obtain the best data from
NIH research dollars. For this reason, I urge you to provide $250
million for extramural facilities construction at the National
Institutes of Health (NIH) in your fiscal year 2001 bill.
In addition to providing significant funding increases for NIH--
including increased funds for extramural research infrastructure--I
thank you for raising the salary cap imposed on extramural researchers
from Executive Level III to Executive Level II ($141,000) in last
year's bill. The higher salary level will allow many institutions to
attract and retain the best investigators in their respective academic
research programs. However, under the Senior Biomedical Research
Service (SBRS) program on the NIH campus, the NIH can pay its senior
investigators up to $151,000--roughly equal to what the salary cap on
academic researchers would be if it were indexed for inflationary
increases over the past decade. To seek a level playing field with
intramural NIH researchers, I am seeking your support in raising the
current salary cap to Executive Level I in the fiscal year 2001 bill.
Over the past decade, several trends in the health care marketplace
and fiscal stewardship of the public-private partnership have
destabilized research institutions and the pool of specially trained
personnel necessary to continue to push the frontiers of medical
research. For this reason, the medical center supports the proposal
that the NIH establish a Flexible Institutional Support for Health
Research (FISHR) program. This peer-reviewed, three-year grant program
will provide institutional resources to meet evolving needs in research
in the range of $25,000 to $300,000 a year for deans of medical, public
health, nursing and dental schools. We suggest a funding level of $60
million in fiscal year 2001 for this competitive, renewable pool of
accountable resources which will help modify the impact of the recent
stresses experienced by research and academic institutions and will
serve to maintain the integrity of our national research enterprise.
There are many exciting initiatives under development and underway
at the medical center. This year, we are seeking support from this
Subcommittee to complete two floors in the Center for Research on Human
Nutrition and Chronic Disease Prevention facility to expand research in
the area of prostate cancer and women's health. Specifically, we are
seeking $5 million in the Subcommittee's fiscal year 2001 bill through
the Health Resources and Services Administration's Health Facilities
Construction Program for this important project.
Prostate cancer is the most common cancer in men and the second
most common cause of cancer deaths among men. Nationally, one in nine
men will, during their lifetime, be affected with prostate cancer.
Given the high incidence (28 percent), high prevalence (41 percent),
and low mortality (7 percent) of prostate cancer, the need for better
diagnosis, prevention, treatment and supportive care is compelling.
North Carolina and the Southeast have pockets of the highest incidence
and mortality of prostate cancer in the country. Areas of South
Carolina and eastern North Carolina have an exceedingly high incidence
of the disease. One North Carolinian will die from prostate cancer
every 7.3 hours. Explanations of this high incidence have included the
typically Southern high fat diet as well as exposure to agricultural
pesticides. These epidemiologic associations, however, are still
inconclusive and more research is needed. Further, strategies to
prevent prostate cancer by altering dietary habits or environmental
exposures have been incompletely developed. African American men are
particularly prone to prostate cancer for a number of reasons.
Incidence of prostate cancer is higher in African Americans than in
Caucasians and African Americans are diagnosed at later stages of the
disease. The Comprehensive Cancer Center at Wake Forest University
Baptist Medical Center has a long history of achievement in the area of
minority population research as it relates to cancer, and this program
will build on this strength. This program initiative will integrate
basic, clinical and population science research.
In this decade, most women can expect to live 30 years or more
beyond menopause. Several critical health issues and chronic conditions
begin to emerge during this stage in a woman's life, yet we are just
beginning to examine and understand these conditions. This program will
build upon the nationally-recognized work of investigators at the
Medical Center in the area of postmenopausal women. The Medical Center
is already recognized as a world leader in research concerning the role
of hormone therapy in the prevention of cardiovascular and other
chronic diseases. The goal of this program is to establish a well-
integrated primary clinical care program for women in their post-
menopause years as well as expand the research in this area. Developing
and testing multiple models to understand the complex relationship
between estrogen and other estrogen-related products and various
systems in women will be a major focus of this program.
Thank you, Chairman Specter for considering these important issues.
______
Prepared Statement of the FDA-NIH Council
introduction
The FDA-NIH Council appreciates the opportunity to submit testimony
concerning the National Institutes of Health (NIH) as the world's
largest and most distinguished organization dedicated to maintaining
and improving health through medical science, and we consider
investment in medical research to be our greatest hope for a healthy
future. To that end, the FDA-NIH Council joins the medical research
advocacy community, the Ad Hoc Group for Medical Research, in
supporting an appropriation of $20.47 billion for the NIH in fiscal
year 2001, with the goal of doubling the Agency's budget within five
years. We believe that it is an important priority for the Congress to
continue its commitment to double the budget of the NIH, and the
Council is indebted to the Committee for keeping the NIH a priority
within the Congress.
The FDA-NIH Council is a broad based coalition comprised of patient
advocates, academic scientists, health professionals, and medical
research-based corporations. These partners in the process of medical
discovery and innovation have come together to seek common ground in
addressing the complex challenges and enhancing the noble missions of
the Food and Drug Administration (FDA) and the NIH.
Medical research and innovation aim to improve health and the
quality of life by finding better ways of diagnosing and treating, and
preventing and curing disease. Breakthroughs come from a process of
innovation, each advance building upon the one that preceded it. From
research in academic, government and industry laboratories, and from
the accumulation of clinical experience in managing disease, our
information about the mechanisms of disease and innovation in medicine
are continually developed. We welcome the opportunity to address the
unique contributions of the government in this regard as it is the
national commitment to the NIH which lays the foundation for our
ability to bring research discoveries from the laboratory to the
patient.
Together with its partners in medical discovery and innovation--
academia, biomedical research industries, voluntary health foundations,
health professionals and consumers--the work funded by the NIH and
subsequent product development with its partners has jettisoned the
United States into international preeminence in this area. All of the
partners in the process of medical discovery are interdependent, each
contributes a critical piece to the puzzle. The success of our national
enterprise is not possible without each piece remaining vibrant and
strong. A healthy partnership between government, industry, academia
and non-profit foundations is critical to maintain the U.S. position as
the world leader in medical research and innovation. Most importantly,
the millions of Americans afflicted with catastrophic, acute and
chronic diseases are the REAL beneficiaries of this partnership.
Breakthroughs such as the development of antibiotics and organ
transplantation, life-extending and life-saving cancer therapies, the
identification of the AIDS virus and the drugs to treat AIDS, have
given the American public a glimpse into the potential offered through
the rapid advances in medical science. But, we must take these ``half-
way'' technologies all the way to the finish line by continuing our
strong funding commitments to research breakthroughs.
The FDA-NIH Council supports the research themes advanced by the
NIH, including:
To Exploit Genomics by accelerating the human genome project;
expanding work on model animal systems; learning to gather and use
complex biological information; and building bioinformatics.
To Reinvigorate Clinical Research by recruiting, training, and
retaining clinical investigators; strengthening clinical research
centers; supporting clinical trials, networks, and databases; and
developing partnerships with managed care organizations, foundations,
industries, and other Federal agencies.
To Harness the Expertise of Allied Disciplines, such as chemistry,
engineering, computer science, mathematics, optics, and physics in
order to work with medical scientists in, for example, designing new
drugs; imaging molecules, chromosomes, cells, and organs; developing
biomaterials; and analyzing bioinformatics and clinical data.
To Reduce Health Disparities at Home and Abroad through research
and training, testing interventions, and building international
research capacity.
We are now on the threshold of the next great revolution in modern
medicine, gene therapy. With the identification of the genes
responsible for a large number of our normal functions and the genetic
abnormalities that cause many diseases, we gain greater understanding
into disease and keys to unlock the future of medicinal research. Each
time researchers discover a gene, they open the door to a new therapy
or cure. Today, when we talk about our medical research enterprise, we
speak from the standpoint of great success and even greater
opportunities.
The health of our nation is dependent upon a strong national
commitment to medical research. As we enter the new millennium, we have
attracted some of the best scientific minds to our national enterprise,
and initiated ground-breaking programs that have already yielded
critical knowledge, and improved patient care and quality of life.
However, we are confronted with the extraordinary challenge of how to
maintain the integrity of our research efforts, and rapidly and cost-
effectively translate that research and development into use by health
professionals and consumers, in both the public and private sectors.
The FDA-NIH Council would like to draw your attention to the
growing capacity of our national research enterprise and the need to
sustain its long term health as it undergoes the transformation
required to meet the challenges of this century.
--Investigator-initiated Research.--The support of basic medical
research through competitive, peer-reviewed, and investigator-
initiated research project grants continues to be among the
highest of funding priorities. As new knowledge is discovered,
it is vitally important for the NIH to support early patient-
oriented research to determine the application of laboratory
advances to persons with disease. Further, training and
educational programs require adequate resources to ensure that
the next generation of clinical scientists is in place to
continue the rapid translation of research from the bench to
the bedside.
--Eliminating Health Disparities.--A key component to eliminate
health disparities among populations in the United States is
medical research and research training. We need to ensure that
multidisciplinary collaborations take place to understand the
causes of health disparities; develop new and improved
prevention strategies, diagnostics, and treatments to reduce
health disparities; and enhance communication of research
results to scientists, health professional, affected
communities, and the public.
--Clinical Research.--To take full advantage of rapid research
advances, the NIH is planning to initiate new pilot and early-
phase clinical trials, thereby speeding the testing of new
therapies. Further, the NIH has expanded the national clinical
trials database, and made it more accessible to the public
through the Internet (ClinicalTrials.gov). The early research
conducted through the NIH is imperative prior to the maturation
and full exploitation of advances in the marketplace.
--Research Facilities.--The sophistication of the research
initiatives requires an ever-increasing sophistication in the
physical plants and research laboratories. Research facilities,
equipment and instrumentation, and animal facilities must be
state-of-the-art in order to fully exploit our research
potential.
The FDA-NIH Council recognizes the inherent difficulties in terms
of weighing the available resources and supporting numerous worthy
federal programs. We recognize and are extremely grateful for the
support that this Committee has provided to the NIH in the past.
However, we also believe that the functions of the NIH are vital to our
economy as well as the health and welfare of our citizens and urge your
support for continued strong funding.
The FDA-NIH Council thanks the Committee for the opportunity to
submit testimony. We appreciate the support of this Committee.
The members of the FDA-NIH Council are: the A-T's Children Project;
Candlelighters Childhood Cancer Foundation; Allergy and Asthma
Network--Mothers of Asthmatics, Inc.; Alliance for Aging Research;
Schering-Plough Corporation; Albert B. Sabin Vaccine Foundation; Merck
& Co., Inc; Pfizer, Inc.; American Veterinary Medical Association;
Joint Council of Allergy, Asthma and Immunology; American Society of
Tropical Medicine and Hygiene; American Academy of Pediatrics; National
Multiple Sclerosis Society; Glaxo Wellcome, Inc.; Cystic Fibrosis
Foundation; Bristol-Myers Squibb Company; Society of Toxicology;
Research Society on Alcoholism; Theracom; Parkinson's Action Network;
Academic Contract Research Organization; American Academy of Allergy,
Asthma and Immunology; Bermuda Biological Station for Research; and the
Cancer Research Foundation of America.
______
Prepared Statement of the National Alliance for Eye and Vision Research
My name is Mike Veeck. I am the owner and operator of five
professional baseball franchises. My daughter, Rebecca, has a blinding
retinal degenerative disease called cone-rod dystrophy. I appreciate
the opportunity to present this written testimony on behalf of the
National Alliance for Eye and Vision Research (NAEVR), an umbrella
organization of thirty professional, lay advocacy and industry
organizations dedicated to expanding our national capacity to address
eye and vision research opportunities. I am an active member of the
Foundation Fighting Blindness, which is an active participant in the
National Alliance for Eye and Vision Research.
I would like to begin by thanking you, Chairman Specter, and
members of this Subcommittee for your continuing commitment to medical
research supported by the National Institutes of Health (NIH) and the
National Eye Institute (NEI). Mr. Chairman, you and your colleagues
have been tremendously supportive of pushing the frontiers through
unprecedented support of the NIH. We know that you have many difficult
decisions with regard to funding priorities in your Appropriations Bill
and we appreciate the strong support that you have provided NIH.
Without this support we would not be on the verge of many new treatment
breakthroughs for blinding eye diseases. Due to the amazing advances in
basic and clinical science, we are beginning to reap the benefits of
our research investment. However, more and more we are forced to
prioritize what areas of research to support because we do not have the
funding available to support all of the opportunities that exist. This
is true in all areas of vision research, and in the public and private
sectors.
The written testimony that follows focuses on three specific
issues:
--Fiscal year 2001 funding request for the NIH and NEI
--Scientific opportunities in eye and vision research
--Why eye and vision research is so important to me personally
fiscal year 2001 funding request
The National Alliance for Eye and Vision Research urges your
continued commitment to the campaign to double the budget for NIH by
fiscal year 2003, referred to as the NIHx2 campaign. We strongly
support the recommendation of the Ad Hoc Group for Biomedical Research
Funding calling for a $2.7 billion, or 15 percent, increase for NIH in
fiscal year 2001, which is the level necessary to pursue a doubling of
the NIH budget.
Within the context of the NIH budget, the National Alliance for Eye
and Vision Research seeks your strong support for the NEI professional
judgement budget calling for a 20 percent increase in fiscal year 2001.
The priorities identified in this budget were a part of long range
strategic plan, Vision Research--A National Plan: 1999-2003, in which
the entire extramural research community participated. This funding
level would provide $90.5 million above current year levels resulting
in an NEI budget of $543 million in fiscal year 2001. This level of
increase for eye and vision research is called for as a result of
previous disparities which have disadvantaged NEI in the NIH priority
setting and funding allocation process. Historically, the NEI ranks
among the lowest Institutes relative to the percentage increase in
funding provided by the Congress.
As you know Mr. Chairman, the professional judgement budget
reflects the funding necessary to continue ongoing research initiatives
and pursue new scientific opportunities that have resulted from the
nation's investment in eye and vision research. I would like to discuss
some of the exciting research opportunities that will be pursued with
this level of investment to assure you that an investment in eye and
vision research will be a wise and cost-effective investment.
scientific opportunities in eye and vision research
Neurodegeneration Research.--Research on neurodegeneration and the
rescue and regeneration of neural cells is an area of tremendous
opportunity with application to many neurological diseases and
conditions, and to cases of traumatic injury, including:
--Rescue of Photoreceptor Cells in Retinal Degenerative Diseases.--
Retinal degenerative diseases such as macular degeneration,
retinitis pigmentosa and Usher syndrome affect more than six
million Americans of every age and race. NEI funded scientists
have already developed several promising experimental
treatments for preventing or dramatically slowing vision loss
from these blinding diseases. Pharmaceutical and neurotrophic
agents, retinal cell transplantation, and molecular and genetic
technologies have shown therapeutic value in laboratory
animals. Further laboratory research is needed to advance these
promising therapies to clinical trials.
--Survival of Retinal Ganglion Cells in Glaucoma.--Retinal ganglion
cells (RGCs) can be studied in culture conditions, providing a
special opportunity for investigating signaling mechanisms that
normally promote survival and how these mechanisms are altered
by injury.
Protection of Nerve Cells in Glaucoma.--Researchers have found
elevated levels of nitric oxide synthase in the optic nerve heads from
human eyes with glaucoma and animal models of glaucoma. By
pharmacologically inhibiting the production of nitric oxide in these
animals, scientists found that axons of the optic nerve were protected
from neurodegeneration.
Resources for Research on the Visual System.--In order to better
understand the molecular and genetic basis for inherited diseases of
the eye, it is essential that research be conducted to identify and
sequence genes that are expressed in the visual system and to identify
disease-causing genetic mutations. There are a number of research
projects, which could be pursued more aggressively with additional NEI
funding. This genetic information will be collected from ocular tissues
that are qualitatively and quantitatively representative of the genes
expressed in the visual system and optimized to detect rare or unique
sequences. It is anticipated that this catalogue of genes expressed in
the visual system will be publicly available in an easily accessible
and retrievable format to facilitate research on eye diseases with the
goal of improving treatment or preventing their occurrence.
Control of Angiogenesis.--Diseases that affect retinal blood
vessels are among the major causes of visual disability and blindness
in this country. These include diabetic retinopathy, retinopathy of
prematurity, neovascular glaucoma, and age-related macular degeneration
in which the proliferation of abnormal new blood vessels can result in
the rapid and irreversible loss of vision. Scientists have discovered
that inhibitors of certain growth factors and enzymes are ideal
candidates for the treatment of these diseases.
Bioengineering and Advanced Instrumentation.--NEI is pursuing the
development of advanced assistive devices for the visually impaired,
adaptive optics and other imaging techniques to improve non-invasive
examination of ocular tissues for both research and disease diagnosis,
instruments to analyze the biomechanics of the eye, and instruments to
analyze visual performance. NEI is continuing research on the further
development of laser-targeted dye delivery systems which could
revolutionize the visualization of blood vessels in the retina and the
treatment of eye disorders; and optical coherence tomography and
confocal scanning laser polarimetry for quantitative measurements of
the retinal nerve fiber layer.
Clinical Research and Health Disparities.--Research in this area
will enhance our understanding of glaucoma, diabetic retinopathy, and
myopia incorporating studies of comorbidity, natural history, and
genetics with special emphasis on populations at increased risk. For
example, rates of blindness from glaucoma are six times higher in
African-Americans than in Caucasians, however age-related macular
degeneration is rare for African-Americans as compared to Caucasians.
Low Vision.--A related area of concern is low vision, or vision
impairment which is not correctable by glasses or contact lenses. As
many as 12 million Americans suffer from visual impairments which
affect their ability to read, drive, work, and perform many everyday
activities we all take for granted. The most common eye diseases that
cause visual impairment in adults are AMD, cataract, glaucoma, diabetic
retinopathy, and optic nerve atrophy. Even more serious are eye
diseases that cause visual impairment in children. These include
certain forms of retinitis pigmentosa, Stargardt and Best disease,
retinopathy of prematurity, cortical visual impairment, and coloboma.
Low vision in children often affects their development and results in
the need for special education, vocational training, and social
services throughout their lives. The cost of these impairments is more
than $22 billion each year.
Under the auspices of the National Eye Health Education Program
(NEHEP), NEI has developed and is initiating a program directed at low
vision in order to increase public awareness about visual impairment
and the impact it has on everyday life. The Low Vision Traveling
Exhibit will be displayed in shopping malls around the country during
the next five years and was recently launched in Birmingham, Alabama.
The program provides information about low vision services and the
devices, which are currently available to assist those with visual
impairments. This effort is directed at those suffering from visual
impairments and also to medical professionals, eye care specialists,
managed care organizations, and family members. NAEVR supports this
public education partnership and urges the Committee to support it as
well.
my personal interest in eye and vision research
Mr. Chairman, I am in a race against time. Each day, my eight-year
old daughter, Rebecca, loses more of her vision to a blinding retinal
degenerative disease called cone-rod dystrophy. Retinal degenerative
diseases are slowly robbing the vision of more than six million
Americans of every age and race. Vision researchers working in NEI
funded laboratories across the country have already developed several
promising therapies that dramatically slow vision loss in animal
models. Although my wife, Libby, and I are excited about this progress,
we also live in fear that sight-saving treatments won't happen fast
enough. With increased support for the NIH and NEI, we can speed these
experimental treatments to clinical trials while my Rebecca can still
see.
Conclusion.--Mr. Chairman, the members of the National Alliance for
Eye and Vision Research are supportive of an increased research focus
on eye and vision disorders, such as those outlined above, and hope
that the Committee will allocate a 20 percent budget increase to the
NEI to allow these critically important research efforts to continue
and expand. As we enter the 21st Century, we must ensure that we are
doing our best to find ways to prevent and treat eye and vision
disorders, and are providing quality eye care services and devices for
those who are already suffering from visual impairment.
Thank you.
______
Prepared Statement of the American Society of Tropical Medicine and
Hygiene
Mr. Chairman and members of the Subcommittee, the American Society
of Tropical Medicine and Hygiene (ASTMH) is pleased to have the
opportunity to present its views on fiscal year 2001 funding priorities
to the Subcommittee. The ASTMH, founded in 1903, is a professional
society of approximately 3,500 researchers and practitioners who are
dedicated to addressing the growing global threat of tropical
infectious diseases. The collective expertise of our members is in the
areas of basic molecular science, medicine, vector control,
epidemiology, and public health. ASTMH is the principal voice for
tropical medicine research within this country.
The staggering burden of tropical and infectious diseases and the
impact on global health confronts us on a daily basis. Poor health and
the spread of infectious disease across borders has profound impacts on
the social and economic development and stability of nations around the
globe. With the enormous volume of travel and trade today, and with the
expanded deployment of American troops, infectious diseases can impact
populations around the globe within 24 hours. The globalization of
infectious disease has brought an increased realization that infectious
diseases represent not only a humanitarian concern but also a bona fide
threat to the health and national security of the United States.
In June 1996, President Clinton issued a Presidential Decision
Directive calling for a more focused U.S. policy on infectious disease.
The State Department's Strategic Plan for International Affairs lists
protecting human health and reducing the spread of infectious diseases
as U.S. strategic goals, and Secretary Albright in December 1999
announced the second of two major U.S. initiatives to combat HIV/AIDS.
The unprecedented UN Security Council session devoted exclusively to
the threat to Africa from HIV/AIDS in January 2000 is a measure of the
international community's concern about the infectious disease threat.
Furthermore, the CIA's National Intelligence Council issued a hard-
hitting report this past January entitled ``The Global Infectious
Disease Threat and Its Implications for the United States.'' The report
concludes that infectious diseases are likely to account for more
military hospital admissions than battlefield injuries. The report
assesses the global threat of infectious disease, stating ``New and
reemerging infectious diseases will pose a rising global health threat
and will complicate U.S. and global security over the next 20 years.
These diseases will endanger U.S. citizens at home and abroad, threaten
U.S. armed forces deployed overseas, and exacerbate social and
political instability in key countries and regions in which the United
States has significant interests.''
Now more than ever, we must continue to be vigilant in our efforts
to control and eradicate infectious diseases through prevention,
treatment, and continued surveillance. As we enter the 21st century, we
must marshal the efforts of government, industry, international
organizations and private foundations if we are to protect our national
security against biological and chemical attacks and protect Americans
against infectious disease and antimicrobial resistance.
national institutes of health
Mr. Chairman, the Society thanks you and members of the
Subcommittee for your strong leadership in the area of biomedical
research and for pursuing budget increases that will effectively double
the NIH budget by fiscal year 2003. As a result of the 15 percent
increase provided to the NIH in fiscal year 2000, new scientific and
research opportunities are being pursued that hold the potential to
prevent and control tropical and infectious diseases around the world.
Your actions reflect the extraordinary importance of biomedical
research to our national interest and are also helping to attract
growing numbers of young scientists to the fields of academia and basic
and clinical research.
The American Society of Tropical Medicine and Hygiene requests your
continued support for the NIHx2 campaign by providing a $2.7 billion,
or 15 percent, increase for NIH in fiscal year 2001 as advocated by the
Ad Hoc Group for Biomedical Research Funding. An appropriation of $20.5
billion for NIH in fiscal year 2001 will allow promising research
avenues to be pursued, including the development of new vaccines and
treatments for diseases such as malaria, dengue fever, cholera,
diarrheal diseases, HIV/AIDS, and a myriad of other viral bacterial,
fungal and parasitic disease agents.
national institute of allergy and infectious diseases
The NIH's tropical disease research program is funded primarily by
the National Institute of Allergy and Infectious Diseases (NIAID) and
there are several important on-going issues relating to NIAID's
research efforts that we would like to highlight.
Malaria.--Globally, infectious diseases are the leading cause of
morbidity and mortality, accounting for 1-3 times the mortality and
morbidity resulting from heart disease, cancer and stroke combined. Of
these infectious diseases, malaria continues to be the most devastating
with a World Health Organization estimate of nearly 500 million
clinical cases and up to 2.7 million deaths annually. Every 30 seconds
a child somewhere dies of malaria. Even in the U.S., over 1,000 cases
of malaria are reported every year, with local transmission being
documented by the Center for Disease Control and Prevention (CDC).
The Society commends the NIH and NIAID for their continued
leadership and focus on malaria. We strongly support the NIAID research
agenda which has made malaria vaccine development a high priority and
has involved collaborative research efforts with private sector
partners, including the Malaria Vaccine Initiative. We urge the
Subcommittee to strongly support these efforts. Malaria is a complex
disease and its control will require a significant research effort in
therapeutics as well as in vaccine development for improved disease
treatment. We encourage an equally vigorous effort in development of
new antimalarial drugs.
Tropical Medicine Research Centers.--The three centers overseas are
most important in facilitating the NIAID's international tropical
infectious disease research collaborations in areas endemic for these
diseases. The research in the center is carried out in the endemic area
by U.S. and local scientists. These centers are critical for the
advancement of our scientific understanding and preparedness for
emerging, re-emerging and other tropical infectious disease threats.
The awarding of these centers is highly competitive. The Society
strongly urges that the Subcommittee express its continued support for
these unique research opportunities.
Challenge Grants.--The Society of Tropical Medicine and Hygiene
would like to thank the Subcommittee for its support of the new NIH
Challenge Grants that were funded through the Public Health and Social
Services Emergency Fund in fiscal year 2000. This initiative was
created to promote collaborative research and development efforts
between NIH, biotechnology, pharmaceutical and medical device
industries to reduce the impact of infectious disease both nationally
and worldwide. This unique investment in research and development will
facilitate greater industry participation in the global effort to
combat tropical and infectious diseases while at the same time
leveraging private sector resources through the program's dollar for
dollar matching requirement. The Society is pleased to note that NIAID
has identified priority areas where the agency believes successful
product research and development efforts could make a significant
impact. The areas identified are malaria, tuberculosis, influenza, and
emerging and resistant infections. The Society strongly urges the
Subcommittee to provide continued support for the NIH Challenge Grant
program in fiscal year 2001.
The Society commends Congress for its leadership in combating
infectious disease and encourages this Subcommittee to work with your
colleagues and the Administration to create additional incentives that
encourage public-private partnerships in the battle against tropical
infectious diseases. We strongly endorse efforts such as the
President's Millennium Vaccine Initiative and legislation pending in
the House and Senate that provide a catalyst for research, development
and production of vaccines and drugs, and make these products
accessible in developing countries hardest-hit by infectious disease.
If we hope to win the war against new and re-emerging tropical and
infectious disease we must engage the collective resources of the
private and public sector--both at home and abroad--in order get
infectious disease under control until we can effectively conquer and
prevent it.
fogarty international center
The Fogarty International Center (FIC) is a unique component of NIH
with a mandate to support training in biomedical research on behalf of
the developing nations of the world. The ASTMH wishes to acknowledge
the significant contributions of the FIC in overall support of tropical
disease research of direct vital importance to American travelers,
servicemen, missionaries, Peace Corps volunteers, and foreign service
officers, among others. Less obvious are the indirect benefits of
training in tropical disease research for our foreign biomedical
counterparts.
The Society supports the continued focus by the FIC to establish
appropriate ethical standards relevant to internationally-based
research. A delicate balance must be achieved between the need to
facilitate vaccine and drug development and the testing of new products
on human subjects in developing countries. The Society is pleased that
the FIC has identified ethical principles and practice in patient-
oriented research as one of four priorities it pursues in establishing
research capabilities in developing nations. The Society encourages the
Subcommittee to be supportive of FIC collaborations with its
counterparts abroad and with international organizations in the pursuit
of a broad ethic to be applied to internationally-based research
initiatives.
centers for disease control and prevention (cdc)
The ASTMH appreciates the Subcommittee's past support for the CDC's
infectious diseases program and requests your support for at least the
President's fiscal year 2001 request of $202 million for these
critically important public health initiatives Increased funding will
help support the development of a national electronic disease
surveillance network that will enable State and local health
departments to respond to infectious disease outbreaks and share
information about infectious disease emergencies and trends. The
President's funding request will also increase the investment in the
CDC's Food Safety Initiative, expanding the ability to more rapidly
identify and track disease-causing bacteria including E. coli and
Salmonella, and Shigella Sonnei, and provide for the implementation of
a national prevention and control plan for hepatitis C.
conclusion
As we enter the 21st Century, we must aggressively pursue the
battle against tropical and infectious diseases, that undoubtedly will
intensify in the years ahead. We must have adequate surveillance
systems and modern infrastructure, coupled with scientific expertise in
both basic and clinical research, if we are to develop the tools
necessary to rapidly respond to, and control, the threats posed by
tropical infectious diseases.
The Society greatly appreciates your support for our nation's
investment in infectious disease research, control, and prevention
activities. We urge you to continue your efforts to double the NIH
budget over the next five years and towards this end we request a 15
percent increase for the NIH budget in fiscal year 2001. We also
request that the Subcommittee support the Administration's proposed
increase of $26 million for the CDC's infectious disease activities.
The Society of Tropical Medicine and Hygiene appreciates the
opportunity to express our views and for your consideration of these
requests.
______
Prepared Statement of the Society of Toxicology
The Society of Toxicology is pleased to have this opportunity to
present its views concerning research in toxicological sciences and its
strong support for the National Institutes of Health (NIH), and
specifically for the National Institute of Environmental Health
Sciences (NIEHS).
The Society of Toxicology is a professional organization that
brings together over 5,000 toxicologists in academia, industry, and
government. The Society of Toxicology is dedicated to supporting
research in toxicological sciences that leads to sound scientific
information that can be employed to reduce uncertainties in assessing
risks to human health and the environment. Enhancing science-based risk
assessment benefits everyone through improved decision-making that
protects the health of people and their environment while at the same
time providing for a more rational use of our limited financial
resources, i.e., a win-win situation.
funding request
First, the Society of Toxicology would like to thank you, Chairman
Specter, and thank your colleagues on this Subcommittee for
demonstrating tremendous leadership in the area of biomedical research
by providing a 15 percent increase to the National Institutes of Health
(NIH) in both fiscal years 1999 and 2000. Your commitment to the
campaign to double the budget for NIH by fiscal year 2003 provides
great hope to Americans afflicted with disease and disabling conditions
and ensures that we will continue to unlock the mystery of disease,
including diseases that may be attributable to causal agents in the
environment.
Mr. Chairman, the Society of Toxicology strongly supports you in
this goal and urges that you continue the NIHx2 campaign in fiscal year
2001. We urge the Subcommittee to support the recommendation of the Ad
Hoc Group for Biomedical Research Funding calling for a $2.7 billion,
or 15 percent, increase for NIH in fiscal year 2001. We also urge the
Subcommittee to support the professional judgement budget recommended
by the NIEHS calling for a 19 percent increase in fiscal year 2001,
given its important role in increasing our understanding of how the
environment potentially affects our health. Whether it is exploring
asthma incidence in children, testing for the toxic potential of
chemicals, or better understanding the genetics underlying
environmental risk factors, NIEHS supported research is leading the way
in bridging the gap between public policy and environmental health
science.
research opportunities
Basic research focused on discerning the mechanism or mode of
action of a particular agent of interest is of fundamental importance
to society. It provides the basis on which we make reasonable estimates
as to whether or not harm might occur to people or the environment
under realistic conditions of exposure. Furthermore, as we explore
mechanisms by which chemical and physical agents may produce toxicity
we learn more about basic biology; thus, toxicology is one of the basic
biomedical sciences.
The quality of life in our Country has improved markedly over the
past century. For example, life span was approximately 45 in 1900 and
today it is 75+ years. Indeed, much of the good life that many of us
enjoy is attributable directly to the proper use of chemicals,
including medicines, to benefit people. Research in toxicology,
including the use of animals, has and continues to play a key role by
defining the conditions of use under which we may employ chemicals for
good causes that benefit society. Yes, there have been some problems/
mistakes made; however, importantly, we are striving to improve and
research focused upon the key aspects of risk assessment (outlined
below) will permit us to continue to make progress.
The scientific basis of risk assessment can be enhanced by the
development of improved test systems and improved means for
interpretation of results. Key aspects of any risk assessment include
an emphasis on: (1) selection of doses used for testing and
extrapolation, e.g., there should not be an emphasis on the use of
excessive doses; (2) dose-response relationships, including
extrapolation from high to low doses, e.g., effects that occur at high
doses do not necessarily occur at low doses; (3) species-to-species
extrapolation; and (4) exposure assessment, e.g., we need to take into
consideration the relationship between doses used in testing as
compared to the amounts that people might actually encounter. It is
important to define conditions under which chemicals may be used,
beneficially with a high degree of safety, and to identify those
situations when a chemical's use should either be restricted severely
or it should be banned. This entails hypothesis-driven research and it
is consistent with the notion that it is the dose which makes the
poison. Members of the Society of Toxicology believe strongly that our
investment in biomedical research must be increased and sustained over
the long-term if we are going to take advantage of the many exciting
research opportunities that exist in environmental health sciences. We
support the research agenda and priorities identified by NIEHS Director
Dr. Kenneth Olden. These can further the development of the science
that is necessary to provide a basis for sound decisions leading to
both improved protection of human health and the environment.
NIEHS research on the Environmental Genome Project will help us to
better understand why some people might be more susceptible to
environmental exposures leading to disease development than others.
This area of risk assessment is one which we know the least about. In
this context, it is important to understand that exposure assessment,
as noted above, is a key aspect of risk assessment. In order to be
credible, a risk assessment must be based upon realistic data
concerning exposure. The Society of Toxicology commends NIEHS for its
planned interagency collaboration with the Centers For Disease Control
and Prevention (CDC) and the Environmental Protection Agency (EPA) to
improve the technological sophistication of exposure assessment and the
use of exposure assessment in developing disease prevention strategies.
The Society of Toxicology supports the partnership between the
NIEHS and the Environmental Protection Agency to establish a national
network of Children's Environmental Health and Disease Prevention
Research Programs to study children's health issues that might be
linked to the environment, such as pediatric asthma and other
respiratory diseases. These illnesses have lifelong adverse health
implications for children and consume substantial health care dollars.
Furthermore, basic research is required in order to learn whether or
not there is a difference in the susceptibility of children as compared
to adults with regard to the toxic potential of particular chemicals.
A strong investment in NIEHS will continue the study of the
potential adverse effects of chemicals that might be able to
disregulate endocrine activity. It is important to ascertain whether or
not these compounds, often referred to as endocrine disrupters,
actually contribute to human disease at the levels they are found in
the environment. The Society is especially pleased that NIEHS is moving
forward with a number of studies to examine the possible linkage
between exposure to alleged endocrine disregulating chemicals and
disorders affecting both male and female reproductive health.
We applaud the NIEHS for spearheading the NIH research effort in
collaboration with the FDA and industry and academia, to develop
biomarkers for the efficacy and safety of new drugs. It is imperative
that promising therapeutics move from the laboratory to the patient in
a more timely manner with a high level of assurance concerning their
efficacy and safety. You can be sure that the Society of Toxicology
will continue to promote this important research collaboration. Under
Dr. Olden's direction, NIEHS has taken a leadership role with regard to
encouraging partnerships involving government, academia and industry to
work on environmental health-related issues.
NIEHS continues to play an important role in the multi-agency
effort to identify the research needs on the safety and efficacy of
herbal medicines. Of the approximate 2,000 herbal products in use, only
a few have been adequately tested for efficacy and toxic potential. As
the use of these alternative therapies becomes more widespread, there
is the need for scientifically valid information about both the
benefits and risks of their use.
superfund hazardous substances basic research program
The Society of Toxicology also wants to express its strong support
for the Superfund Hazardous Substances Basic Research Program. This
program is administered by NIEHS although it is funded through a pass
through from the EPA to NIEHS. The Superfund Hazardous Substances Basic
Research Program is the only scientific research program focused on
health and cleanup issues for Superfund hazardous waste sites. It
represents an important collaboration between EPA and NIEHS, and it
should ensure that environmental cleanup decisions are based on sound
environmental health science.
The Superfund Hazardous Substances Basic Research Program supports
university and medical school research to understand the public health
consequences of local hazardous waste sites, as well as to develop
better methods for remediation. It is important to note that this is
the only university-based research program that brings together
biomedical and engineering scientists to provide the science and
technology base needed for making accurate assessments of human health
risks and developing cost-effective cleanup technologies.
The primary purpose of Superfund Hazardous Substances Basic
Research Program is to provide the scientific basis needed to make
accurate assessments of the human health risks at hazardous waste
sites. In addition, research data is used to determine which
contaminated sites must be cleaned up first, to what extent clean up is
needed, and how best to clean up contaminated sites in the most cost-
effective manner. The Society of Toxicology is disappointed that the
President's budget request reduces funding for this important program
by $11.5 million. We hope Congress will consider restoring funding for
this program to its fiscal year 2000 level of $60 million. We
understand that this funding matter is not under the jurisdiction of
this Subcommittee. With that said, we urge the Members of the
Subcommittee to engage in the necessary discussions with the VA-HUD and
Independent Agencies Appropriations Subcommittee to ensure that these
resources are continued.
conclusion
Once again, thank you for continued leadership in the area of
biomedical research and for considering the funding priorities outlined
above. The Society of Toxicology looks forward to working with you to
continue the campaign Congress initiated two years ago to double the
NIH budget by 2003, and to continue the pursuit of the many promising
research opportunities at hand as a result of the nation's investment
in biomedical research. Under Dr. Olden's leadership, the NIEHS is
taking a leadership role with regard to enhancing the scientific basis
that is necessary in order to make better decisions concerning our
environment.
Thank you.
______
Prepared Statement of Former Congressman Louis Stokes
Mr. Chairman and Members of the Subcommittee, I respectfully submit
the following testimony on my own behalf. As a former member of the
House Subcommittee for Labor-HHS, I am so very proud of the work this
Subcommittee and its House counterpart has accomplished in providing
the vision and the leadership that has led to tremendous strides in the
prevention, diagnosis, and treatment of disease and disabling
conditions and has greatly enhanced the quality of education and
training opportunities for all Americans. As you know, while serving in
the House I shared your interest in developing programs and strategies
to protect those most vulnerable in our society. I am continuing to
pursue this interest by serving as a member of The Pew Environmental
Health Commission. This Commission is an independent panel of
representatives from the health field, industry, government, academia
and the nonprofit community. Launched in May 1999, and chaired by my
colleague, former three-term senator and governor of Connecticut,
Lowell Weicker, Jr., the Commission's charge is to provide leadership,
vision, and visibility for strengthening the country's defenses against
environmental threats.
My interest and passion for these issues brings me here today to
discuss opportunities for this Subcommittee to once again exercise
leadership by strengthening the federal investment in our public health
infrastructure. I submit to you that if our nation's best and brightest
researchers and public health officials had the tools necessary to
develop meaningful disease prevention strategies, we would witness
extraordinary achievements in health outcomes and in reducing the
nation's health care costs.
For more than a quarter century, we have made enormous strides in
protecting our air and water quality and preserving areas of natural
beauty and biological diversity essential to a healthy environment.
Last month, Governor Ryan from the state of Illinois awarded over
$950,000 to plug 148 abandoned oil and gas wells in Clinton and
Lawrence counties and to clean up and restore a waste crude oil site in
Saline County. The state of New York is successfully restoring the
Hudson River, and California is doing a tremendous job of revitalizing
its brownfields. Despite the progress made in cleaning up and
preserving the environment around the country, we have lost our focus
on protecting our children from health hazards arising from exposure to
environmental contaminants.
The Pew Environmental Health Commission is issuing a series of
reports on children's health, including a report on birth defects which
was released this past November and a report on childhood asthma which
will be released later this Spring. As part of the birth defects
report, entitled Healthy from the Start: Why America Needs a Better
System to Track and Understand Birth Defects and the Environment, the
Commission has called for a national approach for monitoring exposures
linked to the environment and building the capacities and strategies
for monitoring and evaluating chronic disease.
Birth defects are the nation's leading cause of infant death in the
United States, resulting in approximately 6,500 deaths annually.
However, a major analysis of national data on birth defects and the
environment has found unexplained increases in certain birth defects
and related conditions that point to the need for strengthening the
public health system. Even though birth defects are the nation's
leading cause of infant death, one-third of the states, the District of
Columbia and Puerto Rico--with a total population of nearly 59
million--fail to track birth defects, and 25 more states have systems
that need improvement. Without this data, public health officials are
literally working in the dark. This makes it much more difficult to
identify emerging disease clusters and tackle environmental threats
that may cause sickness and death in our children.
As many of you know, I took an active role in mitigating the
effects of lead and protecting the health of Americans from lead
exposure during my service in Congress. Congressional intervention,
coupled with the efforts of CDC, EPA, and other private and public
partners, has resulted in the reduction of the percentage of children
in the U.S. with elevated blood lead levels from 88.2 percent in the
late 1970's to 4.4 percent in the early 1990's. This is a prime example
of how having good public health data can significantly improve our
environmental decision-making process.
When the EPA decided to phase out lead in gasoline in 1973,
Congress received considerable pressure to reverse the regulation.
While lead was a well-known neurotoxin, with children being most
vulnerable to permanent neurological damage, it had been widely used in
gasoline to prevent engine ``knocking.'' EPA's theoretical models
suggested that a ban on lead would result in only minimal changes in
human lead levels, but health data from the CDC saved the day by
showing dramatic decreases in human lead levels, persuading Congress
that EPA's restrictions on leaded gas were appropriate. Unfortunately,
CDC does not routinely monitor the level of dangerous pollutants in the
American population despite important past lessons during the great
debate over leaded gasoline. If there is no significant change in our
data collection system, we will be apt to make many costly mistakes.
We have just been reminded of such a mistake with another fuel
additive, Methyl Tertiary Butyl Ether, or commonly referred to as
``MTBE.'' The federal Clean Air Act Amendment requires MTBE to be used
for reformulated gasoline in an effort to reduce air pollution.
Shortly after the beginning of its widespread use in the gasoline
supply, communities around the country began complaining about health
problems--including headaches, eye, nose, and throat irritation,
nausea, and disorientation--linked to MTBE. Yet before its widespread
use we never investigated nor gave the money to CDC to track Americans'
exposure to this chemical--despite having the technology. Since then,
CDC has been given limited funding to study levels of MTBE in humans,
but at this point--despite the numerous complaints and public outcry--
population exposure to this compound cannot be evaluated. We have not
paid appropriate attention to the health problems. Instead, we waited
until leaks in storage tanks led to contaminated water supplies. If we
had focused on health, we could be saving ourselves millions of dollars
in clean up. This was a lesson learned from lead.
This is why we need a modern public health system that readily
tracks the health of Americans. In order to develop ways of testing
whether people have been exposed to hundreds of carcinogens and toxic
substances, we need an increase in environmental health funds. The
President's budget request for the CDC's National Center for
Environmental Health would more than double the $10 million given to
the Federal Government in fiscal year 2000, and would enable the CDC to
move toward monitoring human exposures to more than 100 potentially
toxic substances, up from the current 25. This is a positive first
step, but it is just a start.
The Pew Environmental Health Commission recommends a broader
national approach to biomonitoring that will encompass tracking all
environmental health hazards that science suggests have a linkage to
chronic and infectious diseases. It is estimated that the cost, about
$275 million, or $1 for every man, woman, and child in America, would
develop the monitoring capacity to identify and protect against agents
in the environment that pose great risk to the public's health. This is
a modest price to pay to prevent the many chronic and infectious
disease killers which science suggests are linked to environmental
causes and extract billions of dollars in health care costs each year.
A $275 million investment in the CDC's National Center for
Environmental Health will put real teeth into our nation's effort to
protect the public from environmental hazards and preventable disease.
Mr. Chairman and members of the Subcommittee, I know you realize
the time has come to renew our investment in a public health system
that will prevent the chronic diseases and disabilities that afflict
millions of Americans. While medical science has advanced to conquer
many infectious and chronic diseases, preventing chronic illness
through public health programs has failed to keep pace.
As you know, the President has also proposed to provide a $20
million increase to the CDC's emerging infectious disease program to
develop a national electronic disease surveillance network to assist
local and state public health officials in responding to disease
outbreaks. Again this is a start, however it too represents a piecemeal
approach. The President's plan does not seize on the opportunity to
provide a comprehensive, integrated strategy to the public health
burden of chronic and infectious disease.
While infectious disease remains important, chronic disease is now
the no. 1 killer, responsible for three of every four deaths in the
U.S. annually--about 1.8 million Americans--and a yearly economic cost
of $325 billion. And the numbers are rising! I am, by no means,
suggesting that infectious disease is not important. But while it is
important to remain vigilant in protecting against infectious disease,
we should also focus on causes and prevention of chronic disease and
disability. These health problems might be preventable if only we knew
more about the complex interactions among the social, biological and
environmental factors that affect us.
In 1995, health studies estimated that of the 30 years added to
Americans' life expectancy since 1900, only five years on average are
due to improvements in clinical medicine. The majority, 25 years, are
attributable to public health programs. The steepest decline in
mortality resulted from improvements to environmental conditions that
prevented the spread of infectious disease, such as treatment of
drinking water and removal of wastes, and better nutrition and food
handling practices.
When it comes to resources, our nation rightly spends billions of
dollars to monitor the impact of the environment on plants and animals.
However, as a nation, we do little to monitor the impact of the
environment on our public health.
At the turn of the 20th century, our nation faced the tremendous
challenge of infectious disease by marshaling the resolve and the
resources to conquer these killers. Now at the turn of the 21st
century, it is chronic diseases--such as birth defects, asthma, and
cancer--that are taking an immense toll on our public health. Our
country needs to have a strong public health system. I am asking you to
join me in supporting the following:
--An investment of $275 million for a comprehensive national
biomonitoring program that will alert us to hazards in our
communities that pose serious, but preventable, health risks.
--A renewed commitment to the public health infrastructure that
mirrors the strength of our national commitment to biomedical
research.
It is time for CDC to step up as a leader in disease prevention. It
is with your help that we can make the investment to get them there. We
must rise to this challenge by utilizing the best research, treatment,
and tracking tools to win the war against health threats and disease
that cause enormous human pain and suffering.
Thank you.
______
Prepared Statement of the Kennedy Krieger Institute
Mr. Chairman, Members of the Committee, thank you for the
opportunity to submit testimony for your consideration in the fiscal
year 2001 budget for programs under your committee jurisdiction.
the kennedy krieger institute
The Kennedy Krieger Institute is an independent research
institution located adjacent to Johns Hopkins University. The mission
of the Institute is to focus solely on disorders related to the brain
and central nervous system. Brain related disorders effect one in four
adults and one in ten children at a cost to society of $400 billion per
year. The overall goal of research at the Kennedy Krieger Institute is
to understand the developing central nervous system through the study
of relationships between genes, the brain and human behavior. While the
Institute has special expertise with regard to children, the research
scope includes studies of changes in the brain and the CNS across the
lifespan. Our Institute integrates cutting edge neurobiological
research efforts into a comprehensive program which includes inpatient
and day treatment services; outpatient services; home and community
services; and school programs for children with disorders of the brain.
The Institute is well-known for its strong interdisciplinary research
and care in many fields including medicine, psychology, education,
physical and occupational therapy, audiology, speech and language
therapy, social work, child development, nutrition and nursing. In our
statement to the Committee, we will highlight the efforts of three
federal agencies under your jurisdiction and the important work that
they do to strengthen the capacity of Institute's, such as ours, to
make progress in this important area.
basic and clinical research
We are currently experiencing an unprecedented appreciation of the
benefits to health and life quality that can result from biomedical and
behavioral research. Of particular note is the most welcome present and
predicted increase in public sector funding for basic research and the
dramatic, if not explosive, private sector investment in biology. With
such appreciation and tangible support comes the responsibility to
organize the scientific enterprise so as to produce effective
interventions. And, our challenges are many.
Many children with developmental disabilities and neurological
diseases display severe behavior problems. The mission of our basic and
clinical research, clinical care and educational programs is to improve
the quality of life for these children and their families through a
variety of mechanisms including: providing advanced and comprehensive
treatment services; promoting the widespread dissemination of effective
interventions; and improving treatment technologies through basic and
clinical research. With that said, we support treatment and research
initiatives including but not limited to behavior programs, pediatric
feeding disorders, neuroimaging, basic and clinical research efforts
and training.
The National Institute of Child Health and Human Development
(NICHD) and the National Institute of Neurological Diseases and Stroke
support a number of important initiatives with regard to brain biology;
neurobehavioral assessment and protocol development; translation
studies related to cognition pathways of learning disorders from a
developmental perspective; molecular sciences to further understand the
molecular basis of many developmental disabilities; brain mapping; and
other basic and clinical programs which are at the core of the programs
conducted at the Kennedy Krieger Institute. Further, the National
Center for Research Resources (NCRR) supports important neuroimaging
studies for neuroscience, metabolic and other research. We have support
from the NCRR for our General Clinical Research Center (GCRC) in which
we are conducting studies related to functional imaging. We believe it
is important for the Committee to consider an NIH National Imaging
Network for Clinical Research which will enable NCRR to provide the
resources to create links between the GCRC to the imaging center. This
sort of infrastructure would be vitally important to facilitate and
integrate research networks.
We are very excited regarding planning underway at the NICHD with
regard to pediatric trauma. While injuries and violence are,
respectively, the first and third most frequent causes of death in
children 5 to 18, many clinical treatments are tailored to the adult
population. NICHD is planning a multi-disciplinary, collaborative
programs under the egis of its National Center for Medical
Rehabilitation Research. This program will enable the development and
assessment of therapies specifically targeted to the physical,
emotional and social needs of children through a series of basic and
clinical research initiatives. Mr. Chairman, this initiative marks the
first such federally-funded program of its kind. The NICHD should be
applauded for its efforts in this regard.
We urge the Committee to continue its efforts in support of the
NIH. The Kennedy Krieger Institute endorses the recommendation of the
Ad Hoc Group for Medical Research Funding for fiscal year 2001 which
recommends a 15 percent increase to double the budget of the NIH by
2003.
education
Our approach to severe behavioral problems in many children with
developmental disabilities and severe behavior problems is multi-
focused. The Severe Behavior Program provides comprehensive diagnostic
evaluations, parent training and school consultative services. The
linkage to the child's school and school district is imperative to
develop and effectively implement effective strategies to deal with the
behavioral problems many of our patients present with. This initiative
is complemented by inpatient and outpatient behavioral management
services for children who display severe destruction behavior.
The Institute's Lower and Middle Schools, recipients of the U.S.
Department of Education's National Blue Ribbon Awards in 1996 and 1997,
respectively, are recognized models in special education. Their track
record includes: innovative models of education based upon current
scientific understanding of brain functioning; creative integration of
technology in the classroom; comprehensive curriculum tailored to
unique needs of the student; and training in the field of special
education. We are in the process of opening a high school which will
serve as a national model of a comprehensive approach to school-to-work
transition for youth with serious learning, emotional, neurological,
and developmental disabilities. Our high school has a school-to-work
curriculum. The Career and Technology High School is unique in that it
will be the only program in the area to make career training the
foundation of, and not merely a supplement to, the school's core
curriculum. Drawing on the most current educational, work-readiness,
and industry standards, the high school staff develop partnerships with
business and community groups to develop a state-of-the-art model that
will result in economically and personally rewarding employment for
youth with disabilities. The Career and Technology High School will
take students challenged by severe learning, emotional, traumatic brain
injury, and developmental disabilities and provide a school-to-work
instructional model that addresses the needs of students with serious
disabilities with the skills to undertake meaningful employment.
Students will leave the school with the knowledge and work and social
experience they will need for successful post-secondary employment in a
specific career clusters including: Information Technologies;
Hospitality; Tourism Construction and Manufacturing; Business and
Finance; Arts and Graphics; and Communications. Programs supported by
the Department of Educations, including the Star Schools Program and
the Technology Innovation Challenge Grant program are critical to
enable cutting edge programs such as our to fully develop our capacity
to create model systems which can be applied nationwide. The strong
support that this Committee has provided to these programs in the past
have been a worthwhile investment and we urge your continued support.
national center for behavioral research in children and youth
We, at the Kennedy Krieger Institute, believe that the time is
right to build on our leadership in behavioral research and are
establishing a National Behavior Center to address such problems as
teenage smoking, substance use and abuse, school failure, violence,
teen pregnancy and other behavioral problems of children and use which
have similar causes and solutions. The National Behavior Center will:
(1) study the causes of these behavior problems from multiple
perspectives (e.g. family, society, environmental toxins, neuro-
developmental, etc.); (2) design, evaluate and implement prevention and
intervention programs for these problems; (3) train other professionals
to significantly impact these important child and adolescent behaviors;
and (4) serve as a national resource for other institutions of higher
learning and government agencies.
The National Behavior Center will expand the Institute's efforts
from a primary focus on brain related disorders to the broad spectrum
of child and youth behavior. We expect that it will have a national
impact in terms of understanding children's behavior and how to
identify and prevent the dramatic problems we see on the news every
evening that every parent fears.
As adults in society we have become all too painfully aware of
behavior and health problems that our children are facing. Data
demonstrates that serious attention must be paid to behavior problems
of children and youth to address many societal challenges. School
students are being directly exposed to unprecedented levels of
violence: 80 percent of the children surveyed report witnessing threats
and actual assaults, and 50 percent of students believe that violence
like we saw in Litteton, Colorado could happen in their school.
Tragically 50 percent of students in large city and rural schools know
someone their age who has committed suicide.
But our concerns for our children should not stop with issues
related to violence. Only 58 percent of high school dropouts are
employed, and one-third of major U.S. corporations spend $250 billion
annually to provide basic academic skills training for employees, such
as reading and math. Drug use has a strong link to the use of tobacco
as a ``gateway'' drug. One million youth start smoking each year, 3,000
every day. One million also begin to use smokeless tobacco. As few as
3-5 cigarettes a day can increase the risk of mental retardation of an
unborn child by 25-30 percent.
The use of alcohol by children and youth causes automobile,
pedestrian, and cyclist accidents, interpersonal violence, drowning and
burns, suicides, fetal alcohol syndrome, alcohol poisoning, and alcohol
dependence and abuse. In terms of interpersonal violence alone, alcohol
contributes to 16 percent of all child abuse as well as to over a third
of all robberies, assaults, rapes and murders. The estimated cost to
society is $60 billion annually.
One out of every ten women become pregnant at least once before
they reach the age of 20. One million teenagers each year have an
unwanted pregnancy with a yearly cost to society for medical care,
foster care, decreased work productivity, welfare, and the like of some
$7 billion. Further, an unwanted pregnancy often initiates a cascade of
problems. Children of teenage mothers have lower birth weights, are
more likely to perform poorly in school, and are at greater risk for
abuse and neglect. Sons of teenage mothers are more likely to end up in
prison and daughters are more likely to become teenage mothers
themselves. Most unmarried teenage mothers end up on welfare.
Mr. Chairman, a research and public education collaboration between
the federal agencies you have identified is necessary if we are to get
handle on the best approaches to the rapidly escalating problem of
destructive behavior in youth in our society. It is of paramount
importance to establish a comprehensive and multidisciplinary
initiative that will enhance our understanding of why children become
aggressive, why they commit violent acts, why they are unable to
control their behavior, or why children choose to engage in risky
behaviors. Efforts need to focus on identifying the varied roots of
child and adolescent behavior and violence by addressing an array of
potential influences, including social and cultural variable, family
relationships and family violence, peer influences, child temperament
and health, genetic influences, neurological processes and biological
risk factors. We need to begin to apply what we have learned in the
field of neurobiology, brain mapping, and behavior analysis in the
developmentally impaired individual to the broader population of
children and youth demonstrating behavioral problems.
A coordinated national science agenda addressing the problems of
behavior in children must include these components: enhance research,
ranging from basic and to clinical, from genes to behavior, related to
the behavior of children and youth; employ 21st Century technology for
reliable behavior change; and establish a network to coordinate
disciplines and delivery systems. Mr. Chairman, Members of the
Committee, we applaud your efforts in this regard and look forwarding
to working with the agencies involved in this important initiative.
Thank you for the opportunity to present our views.
______
Prepared Statement of the Society for Animal Protective Legislation
the coulston foundation and the chimp act (h.r. 3514)
The Society for Animal Protective Legislation (SAPL) urges the
Subcommittee to support the efforts of the House Appropriations Labor,
Health and Human Services and Education Subcommittee, led by Chairman
John Porter, to find short and long-term solutions to ensuring the
humane treatment of chimpanzees at The Coulston Foundation.
The Coulston Foundation, a private biomedical research facility
located in Alamogordo, NM, currently houses the largest chimpanzee
colony in the world with over 650 chimpanzees and hundreds of other
animals at the facility. The Coulston Foundation is the only research
facility to be officially cited three times by the U.S. Department of
Agriculture for violations of the Animal Welfare Act (AWA). The AWA
violations are based on numerous negligent deaths of chimpanzees and
monkeys over the past seven years. In fact, the USDA has completed six
formal investigations of the Coulston Foundation and is currently in
the middle of its seventh investigation in as many years. The sixth
investigation ended with an unprecedented agreement between The
Coulston Foundation and the USDA where The Coulston Foundation agreed
to divest itself of 300 chimpanzees by 2002. Sadly, another six
chimpanzees have died since the August 1999 USDA settlement. We have
included six of the deaths reported at The Coulston Foundation: (1)
Terrance, Muffin and Holly died from the well-known side effects of a
drug that was later tested in children; (2) Donna, a former Air Force
chimpanzee, died on November 9, 1999 due to carrying a large, dead
fetus inside her womb for up to two months. TCF veterinarians removed
one liter of pus from her abdomen during a belated C-section and
reported seeing the skull of her decomposed fetus through the ruptured
wall of her necrotic uterus; (3) Another chimpanzee died during a drug
study after losing 29 per cent of his body weight in just 2-4 weeks
(three other chimpanzees lost similar life-threatening amounts of
weight). Responding to the FDA's citation of these violations, TCF
actually told the agency that the lab had ``anticipated'' this fatal
weight loss.
In August 1999, Food and Drug Administration (FDA) investigators
documented more than 270 violations of Good Laboratory Practice (GLP)
regulations at The Coulston Foundation on just three studies reviewed.
According to the FDA, GLP regulations exist to ensure data integrity
and human safety. The FDA confirmed many of the USDA's findings, and
identified new violations of animal welfare laws. On 12/22/99, the FDA
issued a rare Warning Letter, finding the conditions at TCF to be
``serious violations'' with ``wide spread consequences'' for data
integrity and human safety, and stating ``that there will be no further
studies conducted that are subject to the FDA GLP regulations until
corrections are made and verified.''
We understand that the National Institutes of Health may be working
on its own solution to the problem at The Coulston Foundation, yet no
such plan has been presented, and the situation at The Coulston
Foundation has continued to worsen. The problems at The Coulston
Foundation are not new. In fact, circumstances at the laboratory have
been deteriorating for several years. Meanwhile, NIH has done little to
alleviate the situation but provide continued financial support to this
non-compliant laboratory while the USDA and the FDA have filed several
charges against the laboratory for hundreds of violations of federal
law relating to human safety and animal welfare. Now is time for
Congress to step in and put an end to the abuse and financial waste at
this laboratory. NIH has spent over $30 million on The Coulston
Foundation over the past 7 years while nothing has been done to ensure
animal care or data integrity on the research.
The only long-term solution to ensure the well being of the
Coulston chimpanzees and all chimpanzees used in federal research is
the passage of legislation creating a national chimpanzee retirement
sanctuary. Legislation has already been introduced in the House that
would create such a system (Chimpanzee Health Improvement, Maintenance
and Protection Act--H.R. 3514). The Act will create a network of
federal/private-supported sanctuaries to which chimpanzees formerly
used in research will be retired. This approach is not only morally and
ethically responsible, but will save the taxpayers several million
dollars a year.
A critical component of a chimpanzee retirement sanctuary, which we
would like to address, is that of permanent retirement, the cornerstone
of a chimpanzee sanctuary. Unfortunately, NIH has expressed concerns
with this component, reportedly fearing that there might not be a
sufficient number of chimpanzees to use in research, should an
emergency arise which might warrant wide use of the species for
research purposes. To address this concern, we wish to present the
following details designed following the recommendations presented in
the 1997 NIH requested and funded National Research Council (NRC)
Report, Chimpanzees in Research: Strategies for Their Ethical Care,
Management and Use. The NRC report specifically recommends that NIH
maintain a core population of chimpanzees in case of just such
emergencies. However, the report further states that the current
chimpanzee population is above and beyond the number necessary both for
current research needs and anticipated emergency use. It therefore
concludes that several hundred ``excess'' chimpanzees should be retired
to sanctuary facilities. The report suggests that to do so makes
financial and moral sense. The sanctuary system would only apply to
chimpanzees clearly no longer needed for research. It would not prevent
the use of chimpanzees in research, nor would it prevent NIH from
maintaining a ``reserve'' of chimpanzees in case of an unforeseen
public health emergency. In addition, once a chimpanzee is no longer
needed for research, the respective research facility has the sole
authority to retire the chimpanzees, not the animal welfare community.
This is especially important because there are currently several
research facilities ready and willing to retire chimpanzees. The
creation of a permanent retirement sanctuary system has the broad
support of primate specialists including Dr. Jane Goodall, Dr. Frans de
Waal, Thomas Insel, M.D., Thomas Gordon, Ph.D. and Michael Kastello,
D.V.M., Executive Director, Research Resources, Merck & Co., Inc. to
mention a few. We hope this information will satisfy any concerns NIH
may have regarding permanent retirement of chimpanzees.
Former National Academy of Science official and supporter of
national sanctuary system Thomas Wolfle, was correct when he said that
the NIH is ``morally responsible'' for caring for the chimpanzees it
paid to breed and infect. It is time to live up to our moral
obligations, first by providing alternative care for the chimpanzees at
The Coulston Foundation, and then by creating a sanctuary system to
provide permanent retirement to the Coulston chimpanzees and the
hundreds of other chimpanzees who remain warehoused in laboratories.
stolen and fraudulently obtained family pets are being used in taxpayer
funded experiments
Approximately 100,000 dogs and cats are used for research purposes
in the United States each year. The majority of these animals are
obtained from breeders who raise the animals under controlled
conditions and have extensive information on the health status and
genetic background of the animals. Other dogs and cats are obtained
directly from municipal pounds or the animals may come from breeding
stock within the research facility.
Unfortunately, despite extensive documentation strongly
discouraging the practice, some research facilities are still
purchasing dogs and cats from random source dealers. These dealers,
with a Class B license designation by USDA, are notorious for selling
animals to laboratories that have been acquired through theft or fraud
and for their widespread failure to comply with the minimum
requirements under the Animal Welfare Act.
Recognizing the severity of the problem, the U.S. Department of
Agriculture increased its enforcement efforts at the premises of Class
B dealers approximately three years ago. Stronger enforcement drove
some of the random source dealers out of business, but it has not
solved the problem. These dealers continue to fail to maintain the
legally mandated records identifying where they are getting the dogs
and cats they sell to laboratories for hundreds of dollars each.
The records are not completed (and traceable to a legitimate
source) because these animals are being purchased from illegal sources
(people who have not bred and raised the animals and/or did not
willingly give them up for research purposes). For example, the
inspection report from a USDA-licensed dealer in Iowa cited the
following apparent violation, ``Records indicate that 290 dogs were
sold to research, but only 83 animals exhibit required acquisition
paperwork by this licensee. Fully 207 adult dogs are not accounted for
via the release forms paperwork. Also, the dealer is listing himself as
the source of animal acquisition, when this dealer is actually
acquiring animals from a variety of individuals. . . .''
This dealer has allegedly supplied more than one thousand dogs for
experimentation that he acquired through fraud. Further, it is alleged
that the individuals who bred and raised the animals were deceived by
the dealer into believing that their dogs, former racing greyhounds,
were being adopted to good homes. This situation became public this
month, since then the dealer has disconnected his home and business
telephone service. Now he is under investigation by USDA and the
Wisconsin State Division of Gaming. As is usually the case, it is too
late to rescue any dogs since all of the animals the dealer sold to
laboratories have been euthanized following their use in
experimentation.
Meantime, the National Institutes of Health continues assuring
Congress and the public that they are ``committed to ensuring the
appropriate care and use of animals in research.'' NIH has left the
decision of whether or not to use dogs and cats from Class B dealers
``to the local level on the basis of scientific need.'' NIH
acknowledges ``Class B dealers provide biomedical researchers with
animals that may not be available from other sources, such as
genetically diverse, older, or larger animals.'' In fact, the animals
needed are available from other sources; genetically diverse, older or
larger animals could be acquired directly from those pounds that choose
to supply animals for experimentation.
The distinction between non-purpose-bred animals from pounds versus
Class B dealers needs to be made and emphasized. By using Class B
dealers instead of pounds, researchers are contributing to the problem.
In their search to fill researchers demands for ``genetically diverse,
older, or larger animals,'' random source dealers are stealing pets
from backyards and farms or they are acquiring animals through fraud by
collecting animals offered ``free to a good home.''
Following is a statement recently circulated on the web from a
gentleman in Jonesboro, Arkansas: ``I am no animal rights activist--I
am a neurosurgeon, an avid hunter, conservationist, dog lover, horseman
and all-'round country boy. I was brought up to believe in caring for
the animals that we own and I love my 4 year old black Lab, Rebel,
second only to my kids. He was stolen from my home on Dec. 18, 1999. I
have solid information that he was taken by (or for) a nearby `buncher'
who sells dogs to research facilities. . . . As a neurosurgeon, I
support animal research for worthwhile purposes when the data cannot be
acquired any other way and when the animals are properly procured and
properly cared for--but not when they are our pets that have been
stolen.''
Each year as NIH and the researchers it funds fail to take action,
more companion animals are stolen and the numbers of distraught and
outraged pet owners continues to grow. This taxpayer financed supply,
which has continued for decades, desperately needs to stop.
Last year the Subcommittees in both Houses of Congress provided
report language reflecting their regarding Class B dealers. We greatly
appreciate the interest of this Subcommittee in this issue.
Unfortunately, we must report that the problems continue and no action
has been taken. We therefore respectfully request the Subcommittee
include the following language in the appropriations bill: ``None of
these funds shall be used for research which utilizes dogs and/or cats
obtained from random source Class B dealers.''
Implementation of this policy will allow research utilizing dogs
and cats to continue--unhindered by the dark shadow currently cast by
Class B dealers and their illegal practices.
nih needs to redo the animal care and use section of its regulatory
burden report
In the fiscal year 1998 budget, the House Committee on
Appropriations requested an effort by NIH to streamline and rationalize
duplicative and unnecessary federal regulations that govern extramural
scientific research. The report drafted by NIH failed to focus on the
internal regulatory burden that NIH has the power to address. Instead,
the report is being used as a vehicle to assault the federal Animal
Welfare Act by those who wish to dismantle it.
The use of animals in research includes a weighty responsibility to
ensure the best possible care and treatment for these animals whose
lives will be sacrificed following experimentation. Animals who are
treated well will produce more sound research results with a lower
variance. The Animal Welfare Act is the chief federal law ensuring
proper treatment of laboratory animals and due consideration of
alternatives.
The Improved Standards for Laboratory Animals amendments to the
Animal Welfare Act were adopted in 1985 following widespread public
concern and extensive documentation of the need for legislation and of
the failure of institutions to self-regulate, hearings in both the
House of Representatives and the Senate, and careful consideration and
negotiation. Many researchers and the lobbyists who represented them
fought against this law, as those before them fought against the
Laboratory Animal Welfare Act of 1966 (later renamed the Animal Welfare
Act). Having lost that battle, opponents fought against regulations for
enforcement of the law until weakened regulations were finally adopted
nearly six years later. Now, we are faced with an effort to dismantle
the remains.
NIH should take an introspective look at ways in which it can
reduce the regulatory burden to researchers and better streamline the
process. For example, following is a review of site visits:
There is great usefulness in the current system that mandates, at
minimum, bi-annual inspections by the IACUC (self-regulation), but
augmenting this with the unannounced inspections by USDA veterinary
inspectors. Law mandates annual inspections by USDA. Review of USDA
inspection report forms provides powerful evidence of the utility and
great need for these compliance inspections. USDA has reported that it
finds noncompliance with the minimum requirements under the Animal
Welfare Act at 45 percent of the facilities it inspects.
Perhaps NIH can do away with their site visits since this is not an
activity that they undertake with regularity. In those instances where
a registered research facility receiving NIH funds is not in compliance
with the law, perhaps it is a USDA inspector, already familiar with
inspection of the facility, who should be sent in to conduct an
unannounced inspection, rather than a team of individuals organized by
NIH who make a scheduled visit.
This is but one example of the usefulness and practicality of the
Animal Welfare Act. And an example of the need for NIH to pay
particular attention to ways it may be able to improve the process
internally.
Thank you very much for your consideration.
______
Prepared Statement of the Facioscapulohumeral Society, Inc.
Mr. Chairman, it is a great pleasure to submit this testimony to
you today.
My name is Daniel Paul Perez, of Lexington, Massachusetts, and I am
testifying today as President & Chief Executive Officer of the
Facioscapulohumeral Society (FSH Society, Inc.) and as an individual
who has this devastating disorder.
As a chief patient activist for the tens of thousands of
individuals living with Facioscapulohumeral Disease (FSHD) in the
United States, I will continue to argue the case of wanting to live
life free from disease.
My testimony is about the profound and devastating effects of a
disease known as Facioscapulohumeral Disease which is also known as FSH
Muscular Dystrophy or FSHD and the urgent and immediate need for NIH
funding for research on this disorder. In past years (1994, 1995, 1997,
1998, 1999) and again this year we will submit testimony before both
House and Senate Committees which states that the National Institutes
of Health (NIH) and Congress could help bring about a significant
research and scientific discovery program which, with modest
investments, would benefit hundreds of thousands of people worldwide.
The FSH Society has previously informed the members of this
Committee of the United States Congress on the need and rationale for
research on FSHD. We have updated you on the most recent developments
in clinical medicine with respect to FSHD, kept you abreast of the
latest breakthroughs in the molecular genetics of the disease and given
you insight into the difficulty of living a lifetime with this disease.
Thanks largely to your efforts, Mr. Specter, NIH research funding
continues to grow to its current level of $17.793 billion annually up
two billion from 1999. Our gratitude fuels our hope for promising
research solutions for FSHD. Ironically, I must in all candor express
our frustration that promising FSHD research support and programs have
yet to appear from the NIH, even in light of Congressional mandates and
report language for such. While NIH has seen a tremendous increase in
funding in the past decade, FSHD research through the NIH has not
benefited at all. In fact, research funding has gone significantly
down, not up. Since the FSH Society first testified before Congress in
1994, FSHD research has decreased from between $300-500,000 to between
$100-250,000. During this time, Congressional directives to NIH
regarding the state of FSHD research have been either ignored or
responded to in an untimely manner. We have met with NIH officials,
testified before the Institute of Medicine (IOM) Committee and taken
the path indicated to put forth our goals and the situation has only
gotten worse.
the fsh society, inc.
The FacioScapuloHumeral (FSH) Society, incorporated in 1991, solely
addresses specific issues and needs regarding facioscapulohumeral
muscular dystrophy (FSHD). The Board of Directors and Scientific
Advisory Board (SAB) of the Society are comprised of the top medical
and research experts in neuromuscular and muscle disease several of
whom are past and current NIH grant recipients, employees of the Howard
Hughes Medical Institute and serve on the prestigious Institute of
Medicine (IOM) at the National Academy of Sciences (NAS). We provide
public awareness of FSHD by providing information, referral, education,
and advocacy on FSHD. Additionally, the FSH Society offers assistance
and support to patients, families, physicians, and other professionals.
The Society publishes a newsletter with information about advances in
research, political action effecting FSHD research and profiles of
people with FSHD. We have awarded $500,000 in grants toward the
prevention, cause and treatment of FSHD for research projects, post-
doctoral and research fellowships and provided training support to
institutions and fellowships to individuals in the field of FSHD
research worldwide. The FSH Society promotes collaborative research and
collects and disseminates research information. The Society organizes
and sponsors annual international and national Scientific meetings on
FSHD as well as annual international and national patient network day
meetings.
the clinical picture of facioscapulohumeral muscular dystrophy (fshd)
FSHD is a neuromuscular disorder that is inherited genetically and
has an estimated frequency of one in twenty thousand (1/20,000). FSHD
affects 12,500-37,500 persons in the United States. The major
consequence of inheriting this disease is that of a clinically
unpredictable and progressive and severe loss of skeletal muscle, with
the usual pattern of initial noticeable weakness of facial, scapular
and upper arm muscles and subsequent developing weaknesses of other
skeletal muscles. Retinal and cochlear disease can often be associated
with FSHD although the pathogenesis and causative relationship to FSHD
remains completely unknown. FSHD wastes the skeletal muscles and
gradually but surely brings weakness and reduced mobility. 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 is 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. Clinically FSHD is quite
variable. It can be very extreme causing devastating incapacity at an
early age or it can be barely detectable in very old age. Often, the
patient lives with the certainty and anxiety that the course of their
disease will be reliably unpredictable and totally uncontrollable. FSHD
can happen to anyone of us.
new frontiers discovered in human genetics through fshd research.
The FSHD gene was linked to the distal end of chromosome 4, a
location known as 4q35, in 1990 by scientists in the Netherlands. At
that time it was assumed that genetic testing would be imminently
achievable and that the identification of the abnormal gene product(s)
would soon follow. Genetic testing is now available though with
reservation for certain patients with complicated novel genetic
presentations. A decade of progress has led to the discovery of a novel
genetic phenomena of crossover of subtelomeric DNA between chromosomes
(4 and 10) in both normal individuals and diseased individuals and to
the discovery that facioscapulohumeral muscular dystrophy may be the
only human disease caused by a deletion-mutation causing a position
effect variegation (PEV). PEV causes DNA in one part of the genome to
affect DNA in other parts of the genome. In FSHD, DNA at the very end
of the chromosome (telomere) interferes with DNA upstream towards the
center (proximal) of the chromosome. Despite remarkable genetic insight
and immense progress by a small team of scientists worldwide, the
nature of the gene product(s) remain enigmatic and the biochemical
mechanism and cause of this common muscle disease remains absolutely
unknown and elusive.
In the meantime, during the past decade, the genes and gene
products for a significant number of other myopathies, most of which
are rarer than FSHD, have been identified and classified. Although
great progress has been made in these other myopathies and muscle
diseases, our ability to intervene, treat and cure these diseases is
rare. Ironically, FSHD research has not led to the identification of
the gene(s) and the corresponding protein(s) encoded by the FSHD
deletion-mutation causing FSHD. Instead, it has led the scientific
community to discover a novel human genetic phenomenon that challenges
the entire view and understanding of Mendelian genetics. In essence,
FSHD has produced the anomaly that forces the scientific community to
question the paradigm of Mendelian genetics. This finding will begin a
whole scientific revolution in human genetics that will have far
greater implications for medical genetics that will extend far beyond
the study of FSHD.
research dollars allocated directly to fshd as well as muscular
dystrophy are minimal.
The Subcommittee members need consider and rationalize the
following numbers. Neuromuscular and muscle disease has one of the
highest cost-of-disease burdens in the U.S. economy. Yet, of $17.793
billion annually given to NIH, $16.5 million is spent on Muscular
Dystrophy and, of that amount, conservatively $250,000 is spent on the
third most prevalent and third largest dystrophy FSHD. That makes nine
hundred twenty one-thousandths (920/1000) of one percent (1/100) of the
total NIH budget for Muscular Dystrophy and fourteen one-thousandths
(14/1000) of one percent (1/100) of the total NIH budget for FSHD.
Clearly, the Muscular Dystrophies as a class of disease are more than
significantly under-funded by NIH. Secondly, FSHD research funding by
NIH is woefully disproportionate given its ranking and severity.
Thirdly, at best, $16.00 and at worst, $5.33 is spent on each person
living with FSHD. The numbers on FSHD and Muscular Dystrophy research
are appallingly and inexplicably low.
Furthermore, muscular dystrophy is frequently overlooked and of no
interest to the pharmaceutical industry, biotechnology industry and
Wall Street. No privately or publicly owned company is currently
pursuing FSHD research. FSHD is not Alzheimer's, Parkinson's disease or
breast cancer with hundreds of millions of research dollars from the
NIH supplemented by the enormous investments of hundreds of millions of
dollars from the pharmaceutical and biotechnology sector. We have
nowhere to go in the private sector and cannot even possibly go lower
at the NIH. We are ostensibly at zero funding. The NIH has failed and
is failing in its public responsibility to the muscular dystrophy and
FSHD citizen by not carrying through on its public health
responsibility.
congressional directive has been and is repeatedly ignored by the nih.
It should be noted that the FSH Society has given twelve (12)
Congressional testimonies in seven years and has succeeded in three
successive years in incorporating report language on
Facioscapulohumeral Disease (FSHD) in both U.S. House and U.S. Senate
Appropriations Committee Reports accompanying the budget. We have had
over one hundred and fifty meetings and interactions with the three NIH
Institutes primarily responsible for FSHD: The National Institute of
Neurological Disorders and Stroke (NINDS/NIH), The National Institute
of Arthritis, Musculoskeletal and Skin Diseases (NIAMS/NIH) and the
Office of Rare Disease (ORD/NIH). We have the distinct honor of working
with the prestigious and talented Directors and Staffs of all three of
these Institutes since 1992.
NIH is seriously out of compliance with previous Congressional
Directives. NIH has not responded and is responding very slowly to the
past three years of Report Language. Four (4) calendar years have
passed and the NIH has still not convened a research planning
conference. NIH is just now convening a research planning conference on
Tuesday, May 9, 2000 responding to your directive three years too late.
We await the results and plan that comes from that meeting. We request
that your Committee ask for and receive the results of that planning
conference in an immediate and timely manner.
The Report Language for 2000 has been responded to in an untimely
manner and mainly ignored. The status of action on Report Language for
fiscal year 2000 will be ``current year items not done''. The 2000
Report Language is as follows: ``The Committee is concerned that NIH
has not responded to a previous request to develop a plan for enhancing
NIH research into Facioscapulohumeral (FSH) disease. The Committee
urges NIH to promptly convene a research planning conference and to
establish a comprehensive portfolio into the causes, prevention, and
treatment of FSH disease through all available mechanisms, as
appropriate. The Director is requested to be prepared to testify on the
status of this initiative at the fiscal year 2001 appropriations
hearing.'' (House Report 3037, p. 81 for NINDS, p. 97 for NIAMS.)
The status of fiscal year 2000 Report Language is as follows: Not
done in the majority. Plan not created and no comprehensive research
portfolio exists. NIAMS has no R01 or P01 grants on FSHD. NINDS has one
R01 grant on FSHD. Intramural research on FSHD is non-existent at NIH.
The Report Language for 1999 has been ignored and the status of the
Report language for fiscal year 1999 is not done. The 1999 Report
Language is as follows: ``The Committee encourages the Institute to
continue and expand research efforts focused on aiding in the diagnosis
and treatment of FSHD.'' (House Report, NINDS Section, p. 103.), and,
``The Committee was pleased with the Institute's response to last
year's request which encouraged NIH to stimulate research in the area
of facioscapulohumeral disease (FSHD). However, the Committee notes
that NIAMS has not responded in developing a plan for enhancing FSHD
research, and has not addressed the question of whether an intramural
program in this area would be beneficial. Therefore, the Committee
urges NIH to conduct a research planning conference in the near future
in order to explore scientific opportunities in FSHD research, both
intramurally and extramurally.'' (House Report, NIAMS Section, p.120-
121.)
The status of 1999 Report Language is as follows: Not done. Plan
not created and research portfolio is not expanding. NIAMS has no R01
or P01 grants on FSHD. NINDS has one R01. Intramural research on FSHD
is non-existent at NIH.
The Report Language for 1998 has been ignored and the status of
Report language for fiscal year 1998 is not done. The 1998 Report
Language is as follows: ``The Committee has heard compelling testimony
about facioscapulohumeral (FSH) disease, which causes progressive and
severe loss of skeletal muscle. FSHD research includes aspects such as
molecular genetics, neurological function and muscular dystrophy
involving multiple NIH Institutes. The Committee encourages NIH to take
steps to stimulate research in this area and requests NIH to develop a
plan for enhancing NIH research into FSH disease (FSHD), including an
assessment of whether an intramural research program in this area would
be beneficial.'' (House Report, p. 101.)
The status of 1998 Report Language is as follows: Not done. Plan
not created and no FSHD specific initiatives are undertaken to
stimulate research. NIAMS has no R01 or P01 grants on FSHD. NINDS has
one R01 grant for the majority of the year. Intramural research on FSHD
is non-existent at NIH.
nih still lacks presence in the area of fshd research.
NIH has not funded any new grants to ``establish a comprehensive
portfolio into the causes, prevention, and treatment of FSH disease''
even though the previous two years of report language request that this
happen. The Committee has asked NIH several times ``to establish a
comprehensive portfolio into the causes, prevention, and treatment of
FSH disease through all available mechanisms, as appropriate.'' And
still, at the time of this testimony not one new P01 or R01 grant will
have been issued on FSHD in the entire past year.
NIH has not implemented or announced any new mechanisms to enhance
funding on FSHD research in the last year despite the fact that last
year's language requests that NIH do this ``through all available
mechanisms, as appropriate.''
NIH continues to inexplicably reject grant applications on FSHD. On
March 8, 2000 a second submission within this year of a major grant
application from a world renowned researcher was left unscored by the
Center for Scientific Review (CSR) study section Brain Development and
Child Neurology 3 (BDCN 3). Additionally, other grants in FSHD have not
been funded within the last year.
review of the nih track record on fshd and congressional directive on
fshd
NIH has ignored and is responding slowly to three (3) and now four
(4) years of Congressional Directives.
NIH has been slow and unorganized in convening the research
planning conference and in developing the research plan on FSHD called
for in the last three (3) years Report Language.
NIH has not even begun to establish a portfolio in the causes and
treatment of FSHD as called for in the past two years of House and
Senate Report Language. A comprehensive portfolio has not even been
initiated.
NIH has not established ``a comprehensive portfolio through all
available mechanisms, as appropriate'' as called for in last years
Language. No new funding mechanisms have been announced.
NIH has not funded any new R01 or P01 projects in FSHD.
There is a complete disconnect between the fact that Institute
Directors state that FSHD is a priority in long range planning papers,
Congressional testimonies before the Committee, in their responses to
questions raised by the Committee and in personal communications and
yet NIH continues to inexplicably reject grant applications on FSHD.
NIH has not yet responded to Congressional questions asked of the
Director of NIH, Dr. Ruth Kirchstein, on February 15, 2000 and of the
Director of the NINDS, Dr. Gerald Fischbach, on February 29, 2000 by
the U.S. House Appropriations Committee, Subcommittee on Labor, HHS,
Education (Hon. Randy ``Duke'' Cunningham).
NIH is far from the $5-10 million needed to accelerate efforts in
the area of FSHD.
In 2000 to date, NINDS has only one issued grant in its portfolio
that is for FSHD. In 2000, to date, NIAMS has no grants presently
issued with FSHD in their title. That is correct, in 2000 NIAMS
currently has funded $0 (zero) on FSHD research projects. NIAMS and
NINDS state that they are beginning the process of organizing the
research planning conference for May 9, 2000 and, less than four weeks
before the conference, we still do not have a final roster for planning
panel participants. NIH must understand that FSHD requires their
attention.
Although FSHD research may have benefited indirectly from NIH
funding of the Human Genome Project, direct funding of FSHD research by
the NINDS and the NIAMS at NIH has been minimal. The total NIH funding
for directly titled FSHD research currently for the fiscal year 2000
(fiscal year 2000) to date is approximately two hundred-fifty thousand
dollars.
FSHD researchers express incredulity with the lack of funds and
rejection of grants submitted by the top laboratories in the world.
we implore the committee to act immediately
Mr. Chairman, we know that the Committee is overwhelmed in hearing
from patient groups such as ours. We know that you trusted that the
Institute of Medicine (IOM), the Center for Scientific Review (CSR) and
the NIH would set their priorities correctly. The truth is that we have
come before Congress to testify year after year, given testimony in a
wheelchair from the back of the room at the IOM as it was not
wheelchair accessible, worked hard to have NIH take a more active,
deliberate and responsible role and yet the NIH is not listening to the
Congress, the scientific community and the patients on this issue.
Mr. Chairman, this is a clear and disturbing trend regarding NIH's
disregard for Congressional Report Language and for the scientific and
medical opportunities present in FSHD research.
There presently is very little funding of FSHD from NIH--perhaps
two hundred-fifty thousand dollars. I re-iterate, this is clearly
inadequate given the recent advances and the high likelihood of making
significant progress in the very near future. With a budget of $17.793
billion dollars, NIH is spending a miniscule amount on FSHD research.
This tiny amount is utterly unconscionable and defies logic and reason
given the prevalence of FSHD and the cost of doing molecular genetics
research in 2000.
Mr. Chairman, we ask the Subcommittee to earmark a dollar amount to
FSHD research. We request that an amount of not less than five (5)
million and not more than ten (10) million dollars be earmarked for
FSHD research. We know that this Committee does not approve of
earmarking. However, the record of six years indicates that NIH ignores
Congressional direction as well as scientific opportunities. Earmarking
appears to be the only way to get NIH attention.
The FSHD community demands that the Congress of the United States
of America take action on funding research on FSHD. We are asking today
for a promise to people living with FSHD which commits to funding FSHD
research in the following areas:
--Cloning the gene, characterizing the nature of mutations in the
gene,
--Launching a major effort to understand the normal function of the
FSHD gene and how its alteration causes the disease,
--Conducting natural history studies to provide a baseline for future
therapeutic techniques, and
--Developing therapies based on information in 1, 2, and 3 above.
Additionally, the FSHD community is requesting that Congress ask
NIH to research and make recommendations on the following:
--Creating a Center of Research Excellence (CORE) for FSHD research,
--Enacting intramural NIH programs for FSHD research immediately,
--Extramural contract programs for FSHD, and
--Programs to attract and expedite extramural grant applications.
The men, women and children who live with the daily consequences of
this devastating disease are your friends, neighbors, fellow taxpayers
and contributors to the American way of life. With an historic 88
percent employment rate and an average educational achievement level of
14 years, we personally bear our burden of the health care costs and
training expenses to prepare for and maintain financial and personal
independence. We appeal to you today to take our hard earned tax
dollars commensurate with our numbers and valuable contributions to
American Society. We urge the United States Government to allocate a
proportion of our tax burden toward research on FSHD.
This is the United States of America, and in a country as great as
ours with all of its technical means and ability it should be
absolutely clear that the number one priority for individuals with FSHD
and the one absolutely commanding imperative for the Federal Government
is to initiate and accelerate in any way possible, research on FSHD.
With modest funding and a clear direction from Congress to the NIH to
support research on FSHD significant progress can be made in conquering
and eliminating this and other devastating diseases.
Mr. Chairman and members of this Committee, let us remember that as
the Constitutional Convention at Philadelphia drew to a close in 1787,
James Madison noted some concluding remarks by the elder statesman,
Benjamin Franklin. Franklin's observations had to do with a sun painted
on the back of the chair of the presiding officer. He said, ``often and
often in the course of the Session, and the vicissitudes of my hopes
and fears as to its issue, I looked at that behind the President
without being able to tell whether it was rising or setting. But now at
length I have the happiness to know that it is a rising and not a
setting sun.''
Our founding forefathers toiled, fought and worked for Liberty and
Freedom from oppression. They fully recognized that if their partial
liberty gave way to full fledged oppression, the opportunity for
freedom would be lost for a long time and that liberty threatened can
be recovered. Living with a lifelong progressive and chronic
neuromuscular disease imposes the same thoughtful consideration.
In the same way as our forefathers, before the founding of this
great country, I too, lose my physical Liberty every day as naturally
and eventually as the sun rises and sets. My liberty is in constant
decline and my happiness and courage sometimes is setting as the sun to
the West. Everyday I choose to fight on, I am curious to know about
what the next day will bring, simply curious. Despite the full fledged
constant decline of my liberty, I live for the rising sun and have the
faith that this country is great enough and powerful enough to enact
change where it is needed. My liberty will surely be lost in my life
time if I do not find it within me to fight for the recovery of my
liberty and freedom from my natural born oppression. It is my duty and
my obligation, as a citizen of this country, to act as my ancestors and
their fathers did to ensure that the government acts responsibly
carrying out its duty to uphold the public trust.
Mr. Chairman, we trust your judgement on the matter before us.
Please remember, we need your help to ensure that the sun is rising on
FSHD.
Mr. Chairman, again, thank you for providing this opportunity to
testify before your Subcommittee.
______
Prepared Statement of the Scleroderma Research Foundation
The Scleroderma Research Foundation appreciates the opportunity to
submit this written statement urging Congress to become our partner in
pursuit of a cure for scleroderma.
As we have in past years, the Scleroderma Research Foundation asks
for a partnership that combines the strengths of the private, academic
and public sectors in seeking a cure for this debilitating, often fatal
disease, which strikes half a million Americans.
Scleroderma is a chronic, degenerative disorder that leads to the
overproduction of collagen in the body's connective tissue. The
overabundance of collagen hardens the connective tissue (scleroderma
means ``hard skin'') and damages the organs involved. About eighty
percent of scleroderma patients are women. In approximately half the
cases, the primary organ involved is the skin, which hardens and scars,
often causing severe pain and disfigurement. The other half of patients
suffer from systemic sclerosis which hardens internal organs, such as
the heart, kidneys and lungs. Almost seventy percent of patients with
systemic sclerosis die within seven years of initial diagnosis.
The Scleroderma Research Foundation was established to fill a
virtual void in research on this awful disease. From scratch, the
Foundation has built an effective, respected, progressive research
program dedicated to finding a cure for scleroderma. We have made
astounding progress, to the point that our team of advisors and
scientists agree that scleroderma is now a solvable problem. The
researchers at our two centers--t University of California San
Francisco and at Johns Hopkins University--ave made great advancements
in understanding the key processes in the fibrosis and vascular
problems of scleroderma. In other groundbreaking investigations,
researchers have found several key antibodies that are unique to
scleroderma. This work clearly points the way to identifying the
environmental factors which lead to disease development, as well as
helping isolate genes involved in its predisposition. Remarkably, these
breakthroughs have been accomplished almost exclusively through funding
from private donations. The lion's share of donations are contributed
by individuals, many who are scleroderma patients, their family and
friends, and many who have lost loved ones to this disease.
At a time when we have renewed hope for a cure, we need help to
reach our goal. The breakthroughs we have achieved have advanced our
understanding of scleroderma and brought us closer to a cure. There is
a surge of interest from scientists in related fields in opportunities
to collaborate on this research. The right people and technology now
exist to cure this disease. It is only a question of providing the
resources necessary to get the job done. What is needed is your timely
support in bringing the vast resources in science and technology to our
mission. Clearly, there is a life saving opportunity here. Your
partnership is vital if we are to continue to progress.
proposal for partnership
Specifically, the partnership we are seeking is a collaboration
with our research centers at University of California San Francisco and
at Johns Hopkins University. Our request is not for a gift; we are
requesting a match. We ask Congress to allocate funds to match what we,
private individuals across the country, have given to fund our research
centers. Since 1987, the Foundation has invested $4.874 million in
research projects. With this match, we can strengthen our highly
regarded ``cure advocacy'' approach to research, maximizing the
efficiency and progress of our programs.
Cure advocacy brings together scleroderma experts and top
scientists from all basic scientific disciplines to analyze where we
stand in the science of scleroderma and to identify the most promising
research opportunities. Our team comprises scientists from Johns
Hopkins University Medical Center, the National Institutes of Health,
Stanford Medical Center, the University of California San Francisco,
the University of Maryland, and Ohio State University. They participate
in a truly interdisciplinary, multi-institutional environment, working
together, sharing resources and ongoing research information with one
common goal--to find a cure for scleroderma.
Through cure advocacy the Scleroderma Research Foundation, in
partnership with the private and academic sectors, is able to direct
and manage the science on behalf of the patients. The Foundation is, in
other words, driving the science in the direction of a cure. Now, we
ask you to join this partnership in support of well-focused, results-
oriented, disease-driven research, and in support of the hundreds of
thousands of scleroderma patients awaiting a cure.
We are also requesting your partnership in launching a new and
innovative post doctorate program that will bring the efforts of the
best and brightest new scientists to bear on finding a cure for
scleroderma. Our goal is to create a program that focuses scientists in
the field of scleroderma research at the beginning of their career,
when they can devote their work early and exclusively to saving lives.
Here again, the Scleroderma Research Foundation is working to raise
funds for the post doctorate program from private donations. Our
request is for a match of our funding at $1 million (five scientists
located at five laboratories for a three-year period each).
conclusion
As a private medical research foundation, we have attempted,
repeatedly, to create a public/private partnership. Year after year,
there has been no response. What more can we, as an organization
dedicated to an important and singular mission, do in terms of
educating Capitol Hill and raising awareness of the urgency of finding
a cure for scleroderma. There is still, after all, no known cause or
cure for the disease. There are still no FDA-approved therapies. There
are still hundreds of thousands of Americans, mostly women, suffering--
nd dying--rom scleroderma. We cannot do this alone.
From its beginnings, the Scleroderma Research Foundation has
maintained a sharply focused program to insure no time is wasted in
reaching our goal of saving lives. We have accepted this challenge, and
extend the challenge to Congress, to the National Institutes of Health,
and to the medical research community in this country: To channel
today's incredible technologies into helping people and advancing
science that is driven by saving lives. We ask Congress to participate
in our mission by matching our efforts and speeding our progress to a
cure.
Thank you for providing us the opportunity to present this
statement. The Scleroderma Foundation welcomes any questions Members of
the Committee may have.
______
Prepared Statement of the Association of American Universities
Mr. Chairman and distinguished Members of the subcommittee, I am
Dr. Virginia Hinshaw, Dean of the Graduate School and Senior Research
Officer at the University of Wisconsin-Madison. I write today to
provide several perspectives on research, because I've been fortunate
to serve in different capacities during my own research career.
For 25 years, I worked as a scientist and my research, specifically
on influenza viruses, was made possible by the funding I received from
the National Institutes of Health. So I certainly recognize the value,
as well as the highly competitive nature, of obtaining such funding.
Currently, I serve as a university administrator with the goal of
facilitating research efforts of others. I certainly recognize the fact
that the University of Wisconsin-Madison, as a major research
institution, is highly dependent on NIH funding in that over 50 percent
of our federal funding comes from NIH.
Also, I am pleased to represent the Association of American
Universities (AAU), an organization of 61 public and private research
universities across the U.S. and Canada. I currently serve as president
of the Association of Graduate Schools, a group within AAU. Many of you
have AAU institutions within your States. We are joined in this
statement by the American Council on Education, the Council of Graduate
Schools, and the National Association of State Universities and Land-
Grant Colleges.
You have heard over the past several weeks from many organizations
and individuals advocating increases in NIH funding--patient groups,
scientific societies, and research institutions. I speak on behalf of
research institutions, whose faculty translate NIH research grants into
findings that improve human health and well-being. This is a great time
to be in research--there is so much we can do and so much that needs to
be done. A number of exciting, new areas being investigated by faculty
at UW-Madison include genomics, chemical biology, nanotechnology,
biomedical engineering, bioinformatics and many more. These are just a
few examples of the kind of cutting-edge science that is going on all
over the United States, due to this nation's wise investments in
biomedical research at NIH. This investment is improving our lives and
the lives of future generations.
I also know that many of these advances depend on efforts in many
other fields of science, including physics, chemistry, mathematics,
computer science, and engineering. For example, lasers evolved from
mathematicians and physicists studying light waves, and, because of
those efforts, lasers are now common tools in medicine. A decade ago,
cataract removal represented major surgery with substantial
recuperation time; today, this is done with lasers as outpatient
surgery with rapid recovery--that is progress through research by both
physical and biological scientists. We hope that NIH, as well as the
other science agencies, will be provided with the resources needed to
support these other scientific fields that I can attest are critical to
the success of biomedical research.
Past investments in biomedical research have paid off for human
health and for the American economy. For example, recombinant DNA
research at our universities in the 1970's opened the door for today's
multi-billion dollar biotechnology industry. It also allowed us to
begin the human genome project, which is now nearly complete, again
through a partnership between the Federal Government and research
universities. This achievement is the next step in the genetic
revolution which could profoundly alter our approaches to preventing,
treating, and curing disease. Other examples include the tremendous
progress NIH-supported researchers have made in discovering ways to
reduce the tragedy of mother-to-infant transmission of HIV. As NIH has
reported, a 1994 study indicated that zidovudine (AZT) could reduce the
rate of transmission by two-thirds, and once these findings were widely
disseminated, the number of AIDS cases from mother-to-infant
transmission in the U.S. decreased dramatically--by 43 percent between
1992 and 1996.
Advances in cancer treatments enable many of us to be here today,
including myself. I'm a breast cancer survivor and thriver. My father
has had prostate cancer and is still active and vital at 83. So I have
a strong personal, as well as professional interest, in seeing advances
in our understanding of cancer which leads to improved treatments and
hopefully prevention. Along with the subcommittee, I want our
granddaughters and grandsons to be free of those threats to their
health. That will only happen through research.
Even with the great successes in research, I think it is important
to remind ourselves that research is not an investment with guaranteed
outcomes. We are seeking answers to questions with unknown answers.
That means there are wrong turns and dead-ends as we search for those
answers. I always tell students to remember the ``re'' in research
which means that we search and then we search again and again to
determine if our direction is the correct one. I surely believe that
research is a wonderful adventure into the unknown, but that adventure
also involves hard, repetitive, exhaustive work and requires patience
in getting to the long term benefits. We need your steadfast support to
make that adventure productive in the long term for the whole of
society.
This subcommittee has charted us on a bipartisan course to double
NIH funding, which will enable us to continue making progress like this
into the future. The associations I represent here, as well as my
faculty colleagues, are tremendously grateful to Senator Specter and
Speaker Harkin, and all the members of the Subcommittee, for having
provided 15 percent increases in each of the last two fiscal years. We
hope that the subcommittee will be able to repeat that success in the
fiscal year 2001 bill as the third step on the path to double NIH
funding by 2003. As you know, NIH makes grants for multiple years, and
therefore needs stable support. As an investigator myself, I know the
challenge and the stress of maintaining support for an active
laboratory group--that responsibility keeps most of us awake at night,
busy writing more grants to ensure continuity of our research personnel
and programs.
The President's Budget for fiscal year 2001 is a good start, but
its 5.6 percent increase after two years of 15 percent increases would
not even allow NIH to fund the same number of new grants in fiscal year
2001 as the year before, sending a terrible message back through the
biomedical research enterprise. The effects of the extraordinary
funding increases this subcommittee has been able to provide are
already producing positive results in the research community, where
researchers are more likely to be able to get their innovative ideas
funded and graduate students can again see biomedical research as a
promising career choice. I want to underscore the fact that research
universities are the educational homes for graduate students who are
our nation's future researchers--we must keep that future strong. To
accomplish that, we need to keep the momentum going, instead of
reverting to the old boom-and-bust cycles that characterized NIH
funding in the past.
Some have asked whether there are enough good research ideas to be
able to wisely spend a 15 percent increase. The simple answer is yes;
there are truly a wealth of great research ideas yet to be pursued. The
current state of research in so many fields abounds with promise.
Advances in basic research in genetics, cell biology, and biochemistry,
as well as in clinical applications for cancer, infectious disease, and
aging, put us on the brink of discovery in a wider array of disciplines
than ever before. Staying the course by providing another 15 percent
increase will enable further research advances in these areas to the
benefit of all Americans in the future. We recognize that the
Subcommittee is faced with enormous challenges in finding sufficient
funds to keep NIH on the path toward doubling, while adequately funding
other important programs in the bill, given the constraints on
discretionary spending. We hope that an agreement will be reached again
this year to continue investing in basic research to support
investments that are vital to the long-range health of the nation.
Within biomedical research, several areas are particularly
important to note. Support for clinical research remains vital if
laboratory advances are to be translated to the bedside. Likewise,
support for research infrastructure is critical for continued advances.
As research funding increases, additional resources must be invested in
renovating outdated facilities, financing state-of-the-art
instrumentation, and providing new informational and computer
technologies--all are critical and connected priorities. Great research
ideas are constantly being generated by our faculty, staff and students
but pursuing those ideas requires modern facilities and equipment,
along with the analytical and communication tools rapidly emerging
through computer technology.
Let me conclude with a few words about federal student aid
programs. The associations I represent encourage increased support for
student financial aid programs funded by this subcommittee. My efforts
are primarily directed at graduate students, but I know that many of
them could never pursue graduate degrees without the support of student
aid at the undergraduate level. An increase in the maximum Pell grant
of $400, and additional support for the Supplemental Educational
Opportunity Grants (SEOG), the Perkins loan program, Federal Work
Study, the Leveraging Educational Assistance Partnerships (LEAP) and
TRIO programs are essential to assist needy students in accessing
higher education without the accumulation of excessive debt. It is
important to note that high debt loads are a substantial deterrent to
our minority and low income student populations in pursuing graduate
degrees. To have full participation of all students in the educational
process, we must work to reduce that financial barrier.
In addition, I encourage, on behalf of these organizations,
continued and increased support of the graduate education programs
authorized under Title VII of the Higher Education Act. The Graduate
Assistance in Areas of National Need and Jacob Javits Programs support
graduate students with financial need in the sciences, arts, humanities
and social sciences. These programs reduce loan dependency, shorten the
time to degree and create incentives to enter essential but not
particularly lucrative careers, such as teaching and research. And
finally, I encourage support for the Title VI International Education
Programs which are so important to the participation of students and
faculty in today's global community.
Today, as I ask for your support, I also want to assure you that
research institutions recognize their responsibilities in receiving
such support by being accountable and responsible in the use of these
funds. We take that responsibility very seriously and we know that this
government-university partnership demands that we meet those
responsibilities.
Thank you for this opportunity to express our views about funding
for biomedical research and federal student aid programs, and I hope
that the subcommittee colleagues will be as successful in supporting
these areas as it has been in recent years.
______
Prepared Statement of the Population Association of America and the
Association of Population Centers
Thank you, Mr. Chairman for this opportunity to present the
position of the Population Association of America (PAA) and the
Association of Population Centers (APC) to the Subcommittee on Labor,
Health and Human Services and Education on fiscal year 2001 funding for
the National Institutes of Health (NIH), specifically the National
Institute on Aging (NIA), and the National Institute of Child Health
and Human Development (NICHD). You are a long-standing friend of both
organizations and we want to emphasize how grateful we are for your
appreciation and support of demographic research.
As you know, PAA is a scientific and educational society of
professionals working in demographic research. APC is a consortium of
27 leading American population research centers. In addition to their
academic roles, members of both organizations provide federal, state
and local government agencies, as well as private sector institutions,
with data and research to guide decision-making.
Demographic research covers many issues important to our nation,
such as retirement, minority health, disability and long term care,
child care, immigration, labor force participation, worker retraining,
family formation and dissolution, and population forecasting. The
United States is undergoing far-reaching shifts in its demographic
composition and distribution. Such changes often are not recognized or
understood until they confront society with new and immediate needs--
often requiring federal and state expenditures. Incorporating
demographic, social and behavioral research into long term policy
discussions allow such changes to be tracked and anticipated in a
manner that promotes more coherent and efficient planning and policy
implementation.
The National Institute of Child Health and Human Development
(NICHD) and the National Institute on Aging (NIA) provide primary
support for demographic research. We would like to take this
opportunity to share with you information concerning aging, the effects
of welfare reform on children and families, profiles of legal
immigrants, and changes in fatherhood.
the national institute of child health and human development (nichd)
NICHD has a well-established, successful population research
program. NICHD is currently funded at $859.3 million with approximately
$58.6 million of that budget dedicated to research funded through the
Demographic and Behavioral Sciences Branch in fiscal year 1999. Among
the many areas of demographic research supported by NICHD are families
and household composition; marriage and family change; fertility and
family planning; teen pregnancy; mortality; HIV prevention; and
population movement, distribution and composition. NICHD also funds a
highly regarded population research centers program. Population
research centers provide a critical core of professionals who conduct
research in a cost-effective manner. Further, the centers' training
programs are an essential source of population scientists who bring
fresh perspectives, ideas and improved methodologies to demographic
research.
NICHD-supported demographic research provides important, ongoing
information critical to policymakers. We are pleased to provide
information in this testimony that focuses on the Fatherhood
Initiative, the effects of welfare reform on children and families,
profiles of legal immigrants, and the Family and Child Well-Being
Research Network.
Fatherhood
The decline of the incidence of marriage weakens the ties of men to
women and children, with a resulting burden to the welfare system and
to women and children themselves. Thus, it is important to understand
the conditions which help to sustain men's participation in their
family's lives. NICHD, in conjunction with the Federal interagency
Forum on Child and Family Statistics and the National Center on Fathers
and Families, launched a Fatherhood Initiative to review the capacity
of the federal statistical system to conceptualize, measure and gather
information from men about how they became fathers and how they provide
economic and emotional support to their children.
Among the results of this effort are the inclusion of men in the
National Survey of Family Growth and the development of a father's
component in the Early Childhood Longitudinal Survey and the inclusion
of basic research on fathers in the Early Head Start Research and
Evaluation Project. NICHD is also supporting research to understand
factors leading to stable unions among unmarried fathers and mothers.
The roles fathers play in the lives of their children are strongly
affected by the father's relationship to the mother: the access of
fathers to their children is highest when parents are living together.
In cases of divorce, a NICHD grantee has shown that many fathers have
enormous desire to maintain contact with their children, and with
intervention can continue to be major influences in the lives of their
children even after the divorce.
Welfare Reform Effects on Children and Families
The 1996 welfare reform act and the subsequent changes in the
welfare programs of nearly every state constitute the greatest shift in
social policy for low-income families with children since the Social
Security Act of 1935. Since the passage of welfare reform legislation,
welfare caseloads have dropped 40 percent. Yet we know very little
about how these changes will affect these children and families. Both
positive and negative scenarios can be constructed.
The positive scenario is that leaving welfare for a job will make a
mother feel more self-sufficient, raise her self-esteem, bolster her
parenting behavior and provide a better role model for her children to
emulate. Critics point to the challenges of combining employment and
parenting for single parents with few economic resources. Jobs are
difficult to find, low paying, and often do not provide health
insurance. Good and affordable child-care may be difficult to obtain.
The risk for children is increased parental distress, poorer parenting,
inadequate childcare and greater economic hardship.
We simply do not know which scenario will prove most accurate over
time. NICHD is supporting several projects to study the effects of
welfare reform on children and families. The NICHD supported studies in
several cities should provide us with a clearer understanding of the
ways that children and their families are affected by this momentous
change in social policy. These in depth community based studies will
examine the impact of support from family, community networks, and
public programs in helping families make the transition to self-
sufficiency while assessing the impact on child health and development.
Research on Immigration
Understanding the trends in immigration and the characteristics of
immigrants is vital for making informed policy decisions. NICHD, the
Immigration and Naturalization Service (INS), the National Science
Foundation (NSF), and the National Institute on Aging (NIA) have
cooperatively funded a New Immigrant Survey Pilot Study (NIP). This
study will provide immediate policy relevant information on immigrants
in the U.S. and also serve as the foundation for long-term research on
immigrants.
Much of the conventional wisdom on immigrants has been repudiated
in recent NICHD supported studies. For example, legal immigrants are
better schooled, on average, than the native born; the proportion with
postgraduate education is almost three times larger than among the
native born, at the same time, there is also a substantial group
without a high school education. Overall, however, the quality of legal
immigrants entering the U.S. is improving. Influenced by changes in
immigration laws and changing economic conditions, the skill
composition of immigrants to the U.S. has risen.
Family and Child Well-Being Research Network
We would also like to bring you up-to-date on NICHD's Family and
Child Well-Being Research Network--an interdisciplinary data system
focusing on child- and family-related research that relies on cross-
agency cooperation. This year the network has been renewed and
expanded. The new network is comprised of scientists from nine
universities collaboratively working with federal officials from NICHD,
the Office of the Assistant Secretary for Health, of the Department of
Health and Human Services (HHS), the Administration of Children and
Families of HHS, the Census Bureau and the Department of Education.
This network currently addresses a variety of questions about the
interrelations between parent characteristics, family structure and
organization, neighborhood attributes and different forms of social
support. The network is committed to increasing the visibility of basic
research findings to those involved in formulating public policy.
Projects such as the Family and Child Well-Being Research Network
perform the important task of helping synthesize research into sensible
policy solutions.
The Network, in cooperation with federal statistical agencies and
the research community developed a comprehensive set of indicators of
child well-being. The information from these indices are compiled
annually in the report America's Children: Key National Indicators of
Well Being. This report provides a much improved information base that
summarizes the changes in the overall well-being of American children
and families on an annual basis.
PAA and APC enthusiastically support initiatives such as NICHD's
Family and Child Well-Being Research Network that provide quick access
to data and are efficient and effective resources for time sensitive
policy-related research in cross-disciplinary fields.
the national institute on aging (nia)
The NIA also has a well established and widely respected
demographic research program, which provides crucial information on the
implications of an aging of the American population for our country.
Currently, the NIA is funded at $687.8 million, with approximately
$39.6 million of that budget dedicated to demographic research--
training, career development, and demographic, economic and
epidemiological research. As the U.S. population ages and Congress
contemplates sweeping changes in Medicare and Social Security, the
demography of the elderly steadily becomes more important. The NIA has
a strong history of supporting the collection of data, which allows
demographers to study questions of concern to policymakers. Chief among
these is the NIA-supported studies, the Health and Retirement Study
(HRS) and its auxiliary survey, the Asset and Health Dynamics of the
Oldest-Old (AHEAD) study. You have been a solid supporter of these
studies over the years, Mr. Chairman, and we would like to express our
gratitude for your support.
Health and Retirement Study
The Health and Retirement Study (HRS) was launched in 1992 with
baseline interviews for a representative sample of persons born between
1931 and 1941. These respondents were interviewed again in 1994, 1996
and 1998. The most recent round of data collection, HRS2000, is now in
the field. Starting in 1993, the HRS was augmented by the AHEAD (Asset
and Health Dynamics of the Oldest-old--those born before 1924). The
AHEAD respondents were interviewed in 1995, 1998 and the survivors are
being contacted now as part of HRS2000. In 1998, samples of two other
cohorts were added, those born between 1924 and 1930, the so-called
children of the Depression, and those born between 1942 and 1947, or
the ``early baby-boomer cohort''. With the addition of these cohorts,
HRS is nationally representative of the population over age 50. Since
1998, the entire study is now referred to at the HRS.
The original HRS focused on mid-life work and health dynamics.
Biennial data are now available for all respondents on health,
disability, work, health insurance, pensions and retirement plans, and
transfers to and from family. Using the original HRS data, researchers
have been able to explore issues related to health, work and
retirement; prospects for economic security; cognitive changes, health
insurance coverage and use of health care services.
Researchers have long known that persons with higher levels of
wealth and income have better health and live longer. The reasons for
this relationship are not well understood. Is it that income and wealth
cause better health through better access to health care? Or is it that
poor health causes lower levels of wealth and income by decreasing
work, reducing earnings, and increasing health care expenditures? HRS
panel data are shedding some light on these difficult questions. An
economist from RAND has recently shown, for example, that out-of-pocket
health expenses account for only a small share of the reductions in
wealth after an adverse health event. Furthermore, those with health
insurance have just as large a decline in wealth as those without
health insurance. Subsequent to a major health event, middle-aged
persons tend to reduce their work hours or retire completely and use
their accumulated savings in place of earnings. These results have
important implications for spend-down to Medicaid eligibility and old-
age poverty, especially for older women who tend to outlive their
spouses.
Education also is linked to health as well as wealth and income.
Analyses of HRS by researchers suggest that education appears to have
an enduring effect on health decisions. Among respondents who suffered
a heart attack between the first two waves of the HRS, 90 percent of
college graduates quit smoking compared with only 10 percent of those
with less than high school education. Related HRS research also shows
that, among middle-aged diabetics, education raises their health
investment in managing their disease through diet.
Asset and Health Dynamics of the Oldest-Old (AHEAD)
The companion survey of HRS, AHEAD, provides unique information on
the dynamics of health, economic resources and health care services.
The study provides badly needed data on the costs and burdens of
chronic disease and the consequences for the extended family. AHEAD
provides data on how families redistribute their resources across
generations, and how these flows interact with public sector transfers.
AHEAD informs policy decisions on initiatives such as Medicare/Medicaid
coverage for community long-term care and prescription drug benefits.
In addition to economic factors, sustained activity, such as part
time work and volunteering, are thought to affect the well-being and
health of the very old. AHEAD data indicate that there is a beneficial
effect of volunteer work on cognition, health and survivorship.
Volunteer work also is associated with higher education and wealth
suggesting that social activities may be yet another pathway by which
socio-economic status affects health, even in advanced old age.
AHEAD data also corroborate improvements in old age health,
respondents have shown little overall decline in basic cognitive
functioning. Higher education is protective of cognitive ability in old
age.
Finally, PAA and APC are interested in and support the current
efforts to strengthen the Federal Forum on Aging Related Statistics
that coordinates data across federal agencies. The forum is an example
of NIA's interest in supporting NIH's innovative endeavor of
streamlining federal databases and making data accessible to
researchers from varied fields.
conclusion
PAA and APC would like to thank you for the opportunity to present
this information. Demographic data and research are important tools for
policymakers that can both save public funds and promote more informed
decision-making. If this vital research is to continue producing
relevant and timely information, adequate funding and Congressional
support are needed. The Population Association of America and the
Association Population Centers support an increase in the range of 15
percent to sustain the momentum of demographic research in the National
Institutes of Health as part of the broadly based support to double the
funding for the NIH over the next 5 years. However, the increases that
NIH has enjoyed have not been evenly applied amongst the various
institutes; in particular, budgetary growth at NICHD, while
significant, has not kept pace with many of the other institutes. PAA
and APC also support a more even distribution of any increase in
funding for NIH.
______
Prepared Statement of the Parkinson's Action Network
I am one of a million Americans afflicted with Parkinson's disease
and related disorders. I also am President of the Parkinson's Action
Network, which was created in 1991 to give a voice to our community in
the effort to speed research delivering breakthroughs and a cure for
this dreadful disorder.
I have the job today of focusing your attention on the particular
needs of my community, and to convince you that the 2001 budget of the
Labor-HHS Appropriation must--yes, must--include a substantial increase
for Parkinson's-focused research funding.
Why am I so emphatic?
--Because the current federal policy on Parkinson's wastes billions
in public and private dollars coping with its effects, when
millions would produce a therapy that would restore function,
and bring us back into the world.
--Because the disparity in funding attributable to variations,
invisibility or political clout cannot continue.
Parkinson's--the disorder.--Parkinson's is a movement disorder
caused by the degeneration of brain cells that produce dopamine, a
neurochemical controlling motor function. By the time 80 percent of
those cells stop functioning, symptoms of stiffness, tremor and
slowness of movement begin to emerge.
The conventional treatment for Parkinson's is a 30-year-old drug
commonly known as ``L-dopa'' which attempts to replace the missing
dopamine with an artificial substitute. It usually restores function to
a certain extent and it may seem at first like a miracle drug. But it
works inefficiently, it produces side-effects, and eventually it does
not work at all. As the dopamine cell degeneration advances, it strips
away automatic movements needed to walk, talk, swallow, even move at
all.
Despite the common myth that Parkinson's only affects the oldest
sector of the country, in fact the average age of symptom onset is 57,
with a third of all victims' symptoms starting in their 20's, 30's and
40's. As a result, Parkinson's-caused early retirements and forced
disability are the norm. Some lose their jobs simply due to the stigma.
The financial impact is enormous.
In my case, as a practicing lawyer and now running am advocacy
organization for our community, these are my daily struggles: worrying
about getting to a morning meeting and wondering when my first dose of
medication will ``kick in,'' enabling me to function; needing to make a
phone call, but not being able to hold the telephone still with a
shaking hand; seeing others put off by my lurching gait, or my
trembling hand.
The impact on daily functioning.--At some point the symptoms become
an impossible hurdle, as the tiny number of dopamine neurons left
functioning just can't team up with the medication any more, and are
complicated by drug side-effects. At that point, the swing between too
little and too much movement is just too much to manage in the outside
world. We may continue living for a long time, but we drop out of
sight.
As a consequence, we have been neglected. For decades, NIH funding
of Parkinson's research has languished far behind many other diseases,
and far short of the level warranted by the research promise. Estimated
1999 Parkinson's-focused spending totaled less than $45 million, or $45
per patient. Although the NIH reports higher figures, independent
analysis of the actual projects NIH classifies as ``Parkinson's
research'' shows that only about one third of funding supports research
actually focused on understanding or curing the disease. This is a
serious ongoing concern and I hope Congress will take steps to ensure
more accurate accounting of NIH research funding.
There is another important reason the Congress must increase
Parkinson's funding in 2000. As federal taxpayers, we are owed a
rational health spending policy. That requires spending money to cure
us rather than just care for us.
The cost to America.--The cost of Parkinson's in America is
massive. In testimony before the Senate Special Committee on Aging in
1995, Dr. Ole Isacson of Harvard estimated the cost to be in excess of
$25 billion. The Network's surveys of the costs Parkinson's disability
incurs on the country--in treatment, physical therapy, hospitalization,
disability payments, lost productivity, and assisted living--indicate
an equal or greater amount, which translates into a massive burden on
public sources such as Medicare, Medicaid, and Social Security
disability.
The cost is so high because we typically live in a disabled state
for a long time, and the battle against loss of function is ongoing,
and expensive. Parkinson's medication alone is very expensive, probably
costing Americans well over a billion dollars. The largest costs can be
due simply to losing the ability to work or care for oneself, which is
absorbed by the government through higher Social Security, Medicare and
Medicaid spending. This takes a huge toll on the American families hit
by Parkinson's, but it also burdens the society and hits the taxpayer.
This massive financial waste will rise steeply if Parkinson's is
not cured before my generation of ``Baby Boomers'' hits the years when
Parkinson's symptoms are most prevalent. Imagine the additional burden
of lost tax revenue, medical care and disability from Baby Boomers with
Parkinson's.
The scientific promise.--An examination of the scientific promise
of this disorder shows that an investment in Parkinson's research would
return many-fold. The Dana Alliance for Brain Initiatives describes
Parkinson's as ``one of the brightest spots in brain research.'' There
is no doubt that huge, revolutionary breakthroughs are coming, and they
will drive breakthroughs for many other neurological and non-
neurological disorders--Huntington's, ALS, Alzheimer's, spinal cord
injury, diabetes and more. Consider:
--Neural growth factors, animal studies have shown growth factors are
capable of reviving dormant cells and producing dramatic
symptomatic improvement. Further research, including human
clinical trials, is needed.
--Neural cell transplantation, from a variety of sources, has shown
that symptomatic improvement results from the flourishing of
transplanted dopamine neurons. A few patients are now symptom-
free without medication.
--Advances in evidence and understanding of the links between
Parkinson's and environmental factors and chemical compounds
such as heavy metals, herbicides and pesticides.
--Steady increase in insights into the exact disease process, in
which the cells appear to self-destruct after assaults from one
or more of those causative factors.
But without question, these discoveries are coming in slower than
they need to. Many scientists describe immense frustration with the
slow pace of working on these breakthroughs because of the tiny
research investment. That translates directly into a breakthrough
deferred into the future.
According to testimony before the Senate Labor-HHS Appropriations
Subcommittee last year by NINDS Director Dr. Gerald Fischbach, a
focused and adequately funded research agenda could produce new
Parkinson's treatments or even an effective therapy or cure within 5 to
10 years. According to a study by Dr. Roger Kurlan of the University of
Rochester, even a 10 percent slowing of progression will save $327
million per year.
In recognition of both the current costs and tremendous scientific
potential of Parkinson's disease, Congress requested the NIH develop a
Parkinson's-focused research agenda including professional judgment
funding projections for the next 5 years. The NIH held a 2-day
interdisciplinary workshop that included a cross section of some of our
nation's top scientists, clinicians and advocates. This broad,
interdisciplinary approach to evaluating the current state of
Parkinson's research must be continued to stimulate new ideas and
ensure that the limited federal funding is supporting the best, most
promising research.
Although this research agenda is a good first step and acknowledges
the need for substantially increased federal research investment, it is
not a complete and comprehensive plan. For example, while the NIH
research agenda calls for a $71.4 million increase in Parkinson's
research in fiscal year 2001, the Parkinson's Action Network has worked
in concert with the scientific community to identify $244 million in
research projects that could and should be funded in 2001. The NIH
needs to work in close consultation with the research community,
clinicians and patient advocates to expand, revise and update the
research agenda in order to remain relevant and identify the most
promising areas of research.
Congress should encourage the NIH to expand its use of innovative
funding mechanisms such as accelerated review, targeted research,
research supplements and young investigator awards to attract a new
generation of researchers into the field.
And the resources are available to implement this increase. I
applaud the hard work Congress has done the past two years to put the
NIH budget on track to double over five years because of the benefits
to all categories of medical research, and also because it allows for
the needed expansion in Parkinson's-focused research.
Conclusion.--The human suffering that results from Parkinson's is
immense and incalculable. That alone is a good reason to invest in a
cure. The fiscal drain compels it. At the request of Congress, the NIH
has produced an initial plan to pursue a Parkinson's cure. Congress
must now follow through by providing the increase called for--at least
and additional $71.4 million in fiscal 2001--to capitalize on the
unprecedented scientific opportunity. This directed increase for
Parkinson's is a small fraction of the projected overall NIH increase,
and it would bring us one step closer to relieving the enormous burden
Parkinson's places on individuals, families and our nation as a whole.
______
Prepared Statement of the Cure For Lymphoma Foundation
Dear Chairman Specter and Senator Harkin: Thank you for this
opportunity to participate in the fiscal year 2001 process. I am a
survivor of non-Hodgkin's lymphoma--the second fastest rising cancer in
the United States. I am also the founder and President of the Cure For
Lymphoma Foundation (CFL), a nationwide, not-for-profit organization
dedicated to funding research and supporting those whose lives have
been touched by Hodgkin's disease and non-Hodgkin's lymphoma. While
other cancers are on the decline, non-Hodgkin's lymphoma is one of two
cancers where mortality rates continue to increase. The number of
persons diagnosed with non-Hodgkin's lymphoma has doubled since the
early 1970's. Despite exceptional breakthroughs in understanding the
biology of lymphomas, the causes remain unknown. Therefore, as the baby
boomer population ages, this disease is expected to dramatically
increase. For this reason, CFL asks for your assistance in increasing
funding for lymphoma research so that we can find a cure for lymphoma
before it becomes a national epidemic.
your constituents want more lymphoma research
Last year, in order to help heighten lymphoma awareness in
Congress, CFL launched ``CAMPAIGN 64,000''--a national letter writing
campaign. In response, hundreds of advocates sent letters to you and
your colleagues asking to make lymphoma a national priority. Patients
from more than 31 states shared their hopes for new research, as
highlighted below:
Susan of Wallingford, Pennsylvania.--``I am writing to urge your
support for making Hodgkin's disease and non-Hodgkin's lymphoma cancers
of the lymphatic system--a national health priority. I care very deeply
about breakthroughs in lymphoma research because I am the sister of a
person with low-grade lymphoma.''
Patricia of Iowa City, Iowa.--``My brother was recently diagnosed
with non-Hodgkin's lymphoma and currently there is only a 51 percent
survival rate after 5 years. More money for biomedical research will
bring us one step closer toward finding a cure for lymphoma . . . and
all other cancers.''
Sharyn of Bothell, Washington.--``I . . . urge your support for
making Hodgkin's disease and non-Hodgkin's lymphoma . . . a national
health priority. I am a spouse of a survivor. My husband received
chemotherapy in 1995, which severely damaged his heart. Plus the chemo
failed. He got into a clinical trial in 1996 and remained in total
remission until his death in January 1999, which was from heart failure
caused by the chemotherapy. Had the clinical trial drug (now FDA
approved) been available at the time he went through chemotherapy he
would still be with me today.''
LeVonia of Orange, Texas.--``I have been fighting lymphoma for the
past three years. When lymphoma strikes someone, her entire family is
affected; it really takes a toll on the family--physically,
emotionally, financially. It is my hope that you . . . will work toward
funding resources for finding better treatments and, ultimately a cure
for lymphoma.''
Marvin of Wisconsin Rapids, Wisconsin.--``Personally, I am 75 years
old and have been in remission for the past ten months with non-
Hodgkin's lymphoma which has no known cure. It is only because of a
caring oncologist . . . and the professional staff that I have a new
chance and outlook on life. It is most likely that the cancer will
return. My second oldest son, 48 years of age, has been diagnosed with
non-Hodgkin's lymphoma/lymphomcetic leukemia, which according to
authorities is not hereditary. His case is far worse than mine. Your
support for the much needed funds will be greatly appreciated not only
by researchers but by the thousands of persons searching for a cure.''
Patricia of Phoenix, Arizona.--``My father was diagnosed with non-
Hodgkin's lymphoma (low-grade, B-cell) in 1992 and has undergone
various treatments over the past 7 years. Fortunately, he has been able
to take advantage of some of the newly developed and approved
treatments and medications, which have prolonged his life. He's been
lucky in that respect, but there is no cure yet. Please take the next
step by making finding the cause and cure for lymphoma a national
priority!''
Earl of Los Altos, California.--``I am a survivor (so far). The
follicular type I have is currently incurable, and I have suffered with
it for over 12 years. There are very exciting new possible treatments
such as antiangiogenisis inhibitors and other approaches that offer
hope of real cures. Increased funding would offer new hope for finding
a cure before I die.''
increased nci funding has improved the lives of lymphoma patients
As Dr. Richard Klausner, Director of the NCI shared in his written
testimony submitted to your subcommittee in March, increased funding
for the NCI led to the development of a new tool, called the
``Lymphomachip.'' This will assist doctors in identifying which
patients will respond to chemotherapy and which patients should
consider instead alternative therapies like bone marrow or stem cell
transplant. Thanks to this new tool, many patients will not have to
undergo unnecessary chemotherapy treatment as they have in the past.
With your encouragement the NCI has taken an important initial step
towards ``identifying disease specific priorities'' by undertaking a
Progress Review Group (PRG) on Lymphoma, Leukemia and Myeloma, this
fall. The PRGs are important because they are comprised of researchers,
health professionals, industry and advocates who together (1) assess
the state of knowledge, (2) identify scientific opportunity and need
and (3) chart a course for further research. We are hopeful this PRG
will help outline and prioritize a national research agenda for these
three hematologic malignancies.
your subcommittee has twice endorsed lymphoma report language--it is
time to take the next step
Your Subcommittee endorsed lymphoma-specific language last year
that was adopted as part of Senate Report 106-166 and the previous year
as part of Senate Report 105-300. This year we ask that you continue
your support in funding the research essential to improving treatments
and finding a cure for lymphoma. Specifically, we ask you:
--To encourage the National Cancer Institute (NCI), National
Institute of Environmental Health Sciences (NIEHS), Centers for
Disease Control and Prevention (CDC), Department of Defense
(DOD), Veterans Administration (VA), as well as other key
agencies to develop a national agenda for lymphoma and to
expand research into lymphoid malignancies;
--To ensure funds are available to support new research
opportunities; and
--To further investigate potential environmental, bacterial and viral
factors associated with development of lymphoma.
Finally, we thank you for your consideration in this matter. Should
you have any questions, please feel free to contact us.
______
Prepared Statement of Mended Hearts, Inc.
My name is Warren Greenberg. I am a professor of health economics
and of health care sciences at The George Washington University. I am
married and have a 25-year-old daughter.
I advocate an increased appropriation for the National Heart, Lung,
and Blood Institute. I am a victim of heart disease and as a
beneficiary of the efforts of medical researchers to overcome this
disease. I might also add that I am a member of Mended Hearts, Inc., a
support group of 24,000 members throughout the United States. I have
been appointed lobbying and legislation chairperson of that group--a
volunteer position.
I am 57 years old. I was born with aortic stenosis, a narrowing of
the heart valve. Throughout my entire life I have lived with heart
disease, often incredibly severe.
When I was in my early teens, my physicians did not allow me to
play high-school inter-mural sports, although I was a fine young
athlete. At the age of eighteen I was told not to play ball under any
circumstances. In my early 20s I was told to climb no more than two
flights of stairs. By my early and mid-thirties I began to climb steps
more and more slowly, often pausing to rest. I never carried an attache
case home from work. It was too heavy. I would often balance a large
book on my hips, rather than carrying it outright, in order to blunt
the weight. I would walk two or three blocks on a level street to avoid
going up three or four steps at the end of particular blocks. I could
barely lift my newborn child; I could not help my wife take in the
grocery bags.
On May 7, 1982, at the age of 39, I had open-heart surgery at the
Cleveland Clinic to replace my diseased valve with the valve of a pig.
After my six-week recuperative period I was amazed to find that not
only was I able to walk, but was also able to play tennis, to jog, and
to exercise. I was able to live a normal life.
By August 1988, however, my new valve had failed. On August 31, I
again had cardiac surgery at the Cleveland Clinic to replace the failed
pig valve with an artificial plastic valve, known as the St. Jude's
valve. I am again able to live a relatively normal, very productive
life. And I am deeply thankful for it.
I still take a blood-thinning medicine, coumadin, which helps
prevent clots on my new valve. At the same time, because of the
medicine, I must be cognizant and careful of excessive bleeding. In
1983 I contracted bacterial endocarditis, an infection of the heart
valve, from dental surgery which kept me in the hospital for six weeks.
Whenever, I have dental work, I now get intravenous penicillin to
protect me against such infections. I realize that my valve, as a
mechanical device, may fail at any time in the future.
For nearly 18 years, thanks to the fruits of medical research, I
have been able to travel abroad at least once a year, to jog in the
park, to be a productive author of many scholarly articles and a number
of books on the health care economy. I have been quoted often on my
views of the U.S. health care system and have made many television
appearances. If it were not for the advances in research leading to
improved techniques in open-heart surgery, I would not have seen my
fortieth birthday. I would not be able to look forward to a life of
many rewards and enjoyments.
As an economist. I observe continually the link between monetary
resources and the development of innovation and technology. Health care
research, and cardiovascular research in particular, is no exception. I
also understand as an economist that there are always competing uses
for appropriated monies. However, cardiovascular diseases last year
killed more than 950,000 Americans, more than 151,000 of whom are under
age 65. Despite advances in medical research, these diseases remain the
number one killer in the United States and a leading cause of
disability. From my personal perspective and for those in Mended Hearts
Inc. and others in the United States who have heart disease or will get
it in their lifetime, consistent with congressional resolutions for the
National Institutes of Health, I ask for a doubling of National Heart,
Lung, and Blood Institute budget by year 2003. To reach this funding
goal, I advocate a fiscal year 2001 appropriation of $2.330 billion for
the NHLBI to help reduce further the incidence and degree of heart
disease.
______
Prepared Statement of Erin Bosch
I am submitting this testimony because I am convinced that together
we can make a difference. I submit this testimony on behalf of the
almost one million Americans that are living today with consequences of
congenital heart disease in our nation. For the last four years I have
worked as an advocate for the American Heart Association and during
that time I have seen the difference that being a public advocate can
make in people's lives.
Since my diagnosis of hypertrophic cardiomyopathy at age eight, I
have been through many procedures, both for the purpose of diagnosis
and treatment, including open heart surgery at the Mayo Clinic. I have
had numerous doctor and hospital visits and I will take medication
every day for the rest of my life. I will never compete in athletics
again, which I dearly loved. I face the possibility of many more
procedures during my lifetime. Clearly, the success of additional
research could make my adult years more hopeful. I anticipate that when
the day comes for me to bear a child of my own, I will be able to say
with certainty he or she will be born free of heart disease.
Most people know that heart disease is the number one killer and a
leading cause of disability in adults, but few recognize that
congenital heart defects are the most common defect in new born babies.
Every year thirty two thousand children are born with a congenital
heart defect. I was one of them. Twenty one hundred of these children
will die before their first birthday. I am one of the lucky ones.
I am confident these statistics can be changed. I have addressed
the Committee for the last three years about the importance of
continued research for heart disease and every year you have come
through with critical research dollars. It was funding that this
Committee provided that has allowed for the successful research and
development of surgical procedures, pacemakers and intracardiac
defibrillators that myself and other children depend on. Other devices
and procedures are in the throws of development as we speak which
depend on the continuance of these research dollars. I have great faith
in the determination of our scientific researchers who work day and
night to find new treatment methods for those who suffer with illness
and disease. I also have great faith in you as the doorkeepers of
governmental funding to continue to provide the necessary funds for
children who have been born with heart defects.
______
DEPARTMENT OF EDUCATION
Prepared Statement of the CORE Foundation
key issues for hiv/aids
We are at a critical point in the care of patients with HIV/AIDS.
We have achieved major goals in our basic science understanding of the
course of HIV disease and have applied this understanding to the care
of patients. Recent breakthroughs in drug therapies give reason to be
hopeful for the successful treatment of HIV/AIDS.
Throughout the country, we have witnessed a steady decline in the
number of hospital admissions for AIDS care and outpatient clinics are
experiencing a dramatic increase in the demand for out-patient care and
services. These successes have led to increased numbers of AIDS
patients surviving longer and once again becoming productive members of
society. Although science has taken big steps toward making AIDS a
long-term manageable disease, by no means do we have a cure for the
largest public health crisis of the century.
These favorable trends can be attributed in part to advances in
opportunistic infection prevention and to highly active antiretroviral
therapy (HAART). There are over 200 potent combinations of
antiretroviral treatments that can be used in the fight against HIV/
AIDS. For each of these different regimens and drug combinations, there
is a wide variation in a patient's adherence.
With the hectic pace of the development and release of new drug
treatments and care regimens for HIV/AIDS patients, it can be difficult
even for specialty-care providers, and much more so for community-based
care providers, to keep abreast of the most recent advances in care and
medication usage. Without the ability to keep up with new drug
developments, disease management is difficult, if not impossible, for
community-based providers and patients.
While the technology exists to implement sophisticated education
networks for HIV/AIDS, there is no successful system in place that
provides caregivers and patients the education and scientific tools
needed to ensure that they make the most of the advances in care.
Additionally, recent research has shown that the disproportionate
incidence of HIV/AIDS among inner-city, minority populations is due in
large part to low rates of adherence and lack of effective community-
based, comprehensive, health education and training systems for
providers and patients.
Lack of access to up-to-date information also hinders the ability
of patients to fully understand the importance of adhering to their
prescribed therapy. Unfortunately, incomplete adherence with medication
regimens greatly increases the risk of the emergence of strains that
are resistant to the newest therapies thus increasing the likelihood of
the spread of HIV/AIDS.
Low rates of adherence can most often be attributed to the
following:
Cost.--The cost for HAART therapy is enormous, as much as $10,000-
$15,000 per patient per year. Although the federal program, AIDS Drug
Assistance Program (ADAP), is designed to provide financial assistance
for uninsured or underinsured HIV/AIDS patients in purchasing required
medications, it has been unable to keep up with the increasing demands;
Testing.--Many individuals are still hesitant to be tested for HIV
and often go without a diagnosis. As a result, patients go without care
until the symptoms become evident and they are in need of immediate
services. Delays in testing result in patients who are much sicker when
they present for therapy.
Education.--Many HIV infected patients are unable to get timely
clinical care or to adhere to complex and difficult drug regimens.
Often patients have little or no understanding of newer therapies and
their potential benefit, resulting in low levels of adherence and
decreased health status.
Disparities among inner city, minority populations are also evident
in the effectiveness of HAART therapies. While there have been dramatic
new developments in HIV care due to these new and more powerful
medications, including a 42 percent decrease in the death rate from
AIDS,\1\ the outcomes have not been as positive for minority
populations.
---------------------------------------------------------------------------
\1\ Centers for Disease Control HIV/AIDS Surveillance Report, June
1998.
---------------------------------------------------------------------------
This disparity in opportunistic infection trends between population
groups most reflects differences in access to the full range of new
therapies now available. It is also indicative of a lack of targeted
outreach, education and adherence enforcement efforts aimed at high
risk populations and at those lifestyles which contribute significantly
to the transmission of HIV.
The treatment of patients with HIV/AIDS in Chicago and other urban
areas is made more difficult by the large number of patients receiving
care and the large number of potential patients whose infections have
not been diagnosed who will ultimately need care.
Specialists alone are not able to provide primary care for all
affected patients, especially those in underserved communities. This
means that other providers need to be trained in the complicated care
of patients with HIV/AIDS to insure that the new HIV medications are
used appropriately and to the greatest benefit for all patients.
To be effective, these community providers must have current
medical data and protocols at their fingertips. They must be able to
access immediate expertise to ensure the most accurate interventions
and care for patients. Today, due to the lack of use of computerized
clinical information systems in health care, especially for HIV/AIDS
care, they are often unable to access this type of critical information
or feedback in a timely fashion.
21st century technology for education as the key
While many piecemeal technology based health education systems for
HIV/AIDS exist throughout the United States, there are none that are
taking full advantage of today's cutting-edge scientific landscape.
The adoption of computerized clinical information systems in health
care lags behind the use of computers in most other sectors of the
economy. There is no HIV educational system that provides care,
clinical assistance and interactive education, while integrating the
patients and community-based providers into the care giving and
decision-making process. Especially given today's technological
advances, this is a striking deficiency in health education systems for
HIV/AIDS.
At this critical time in the evolution of the long-term treatment
of HIV/AIDS, it is important that we focus on the creation and
implementation of comprehensive provider and patient education and
training systems. This focus will:
--Improve ability to manage disease and related conditions;
--Improve treatment and prevention efforts;
--Increase the rate of the early detection of HIV;
--Increase the rate of treatment adherence; and,
--Decrease the spread of HIV.
The Department of Health and Human Services has recognized that
effective education of providers and patients as well as adherence
management programs are the only way to prevent those behaviors that
lead to the spread of resistant strains of HIV. It is critical that the
Federal Government continue to focus its resources on creating
comprehensive HIV education and training systems that fully integrate
specialists, community-based providers and patients and evaluate the
outcomes of those systems.
The CORE Center believes that the most effective educational system
is one which uses today's state-of-the-art technology and creates
interactive networks of education that provide real-time feedback and
enables providers to optimize care for HIV/AIDS patients.
Thus, the Center has proposed the Community and Minority Education
and Training Initiative (COMET) for HIV/AIDS which maximizes the
Center's extensive technological resources and care expertise to create
and implement a unique, regional HIV/AIDS education and training
network for HIV/AIDS providers and patients in community based
settings, especially minority communities.
the community and minority education and training initiative
To address this significant health crises in the minority
communities specifically, the African American community, The CORE
Center in Chicago, Illinois, proposes the implementation of its
``Community and Minority Education and Training (COMET) Initiative''.
This initiative will demonstrate the significant improvements in care,
prevention and education services through the use of a regional
computer network. COMET will expand upon existing technology at the
CORE Center to provide computer assisted patient shared decision making
and HIV/AIDS education, training and care feedback to providers and
patients in the Chicago metropolitan area.
This demonstration project will create a national model of a
technology-based education and training system for specialty and non-
specialty, community-based HIV/AIDS care providers as well as the
education of HIV/AIDS patients. It will address an existing national
need in minority communities for the effective integration of
educational programs to enhance provider performance and improve
provider and patient ability to manage disease. It will improve patient
response and adherence to treatment regimens and place emphasis on the
incorporation of patients into a shared decision making process.
The Community and Minority Education and Training Initiative will
result in several key outcomes including:
--Improve non-specialist and patient access to the most current
information on HIV/AIDS care, treatment, and drug protocols
--Provide critical and, as of yet non-existing, access to immediate
feedback for providers to proposed patient care regimens
--Facilitate the supervised integration of community-based providers
into the care of HIV/AIDS--thus expanding patient access to
care for HIV/AIDS
--Provide a model for computer assisted patient shared decision
making
--Improve physician's and patient's ability to manage HIV/AIDS and
related infectious diseases.
--Improve patient adherence to complex care regimens
--Improve surveillance and response efforts at the local, state and
federal levels
--Increase providers' ability to identify population specific
treatment and care issues
--Reduce the emergence of additional resistant strains of HIV/AIDS
--Provide nationally relevant outcomes data that will be useful to
cities across the United States as they grapple with issues of
access, adherence, and cost and quality of care.
Through the implementation of a community-wide HIV education and
training network, this initiative will provide nationally relevant
outcomes data which will be useful to cities across the United States
as they grapple with issues of access, adherence, and cost and quality
of care.
The CORE Center, with its location in the heart of an inner-city,
minority neighborhood, its single-site location for comprehensive HIV
outpatient services, screening clinic, and its state-of-the-art
information system, is uniquely positioned to implement this
technology-based provider and patient education initiative.
Additionally, because the Center's population is predominately African
American and Latino, it will provide a unique model for improving the
quality, efficacy and cost of care for minority populations through the
use of a technology based education system for providers and patients
of HIV/AIDS care.
Project COMET will demonstrate the efficacy of the technology-based
education and training system in the following areas:
Education.--Demonstrate the ability of a technology based
educational system (or distance learning system) to update and educate
specialty and community-based providers and to educate and involve
patients in a shared decision-making process.
Early Intervention.--Demonstrate the effect of a technology based
educational system on the ability of the community-based and specialty
care providers to target HIV screening of inner-city populations with
sexually transmitted diseases (STDs), so that advances in HIV care will
be made available as early as possible in the course of HIV disease and
prevent risky behaviors that result in the spread of the HIV and
related infectious diseases;
Adherence.--Demonstrate the ability of the system to enable non-
specialty and community-based care providers to implement an aggressive
adherence program to ensure the application of sound treatment
principles and protocols, medication adherence and clinical follow-up
of inner-city, minority patients; and,
Outcomes Research.--Collect and analyze data to measure patient
outcomes, the cost of care by different specialty and community-based
providers as well as patient and provider adherence. In addition, this
initiative will disseminate these findings.
Mr. Chairman, thank you for this opportunity to submit testimony
for the record. We very much appreciated your support in fiscal year
2000 in securing the initial $1.25 million for this important
initiative. We look forward to working with you to secure the remaining
$8.75 million in federal funding to complete this nationally
significant initiative that will thoroughly examine the effectiveness
of a technology based educational system on the improvement of care and
treatment of HIV/AIDS. Lessons learned from this important initiative
will be beneficial not only to the Federal Government as it endeavors
to develop appropriate HIV/AIDS policy, but to cities across the nation
as they grapple with this very complex issue, especially as it pertains
to minority communities where the epidemic is expanding most rapidly.
______
Prepared Statement of the Pinon Community School Board, Inc.
Thank you for this opportunity to submit testimony regarding the
fiscal year 2001 Labor, Health and Human Services, and Education
budget. We are pleased with the long-overdue emphasis that has been
placed on Indian programs in the proposed fiscal year 2001 budget. The
critical needs of Indian Country's educational system in particular
rise above partisanship, recognized by leaders on both sides of the
aisle as a pressing concern worthy of renewed attention by the U.S.
Congress. With this in mind we ask that, at a minimum, your committee
fully support the direct and indirect funds for services to Indian
students contained in the Administration's request, including the
following:
--$115.5 million overall for Indian Education
--$10 million for continuation of the Indian Teacher Corps program
--$5 million to create an American Indian Administrator Corps
--$2.7 million to support comprehensive Federal research on Indian
education
--$20 million for Special Programs for Indian Children
--$50 million earmark for Title I grants to 119 LEAs with at least 50
percent of their students residing on Indian lands
--$200 million earmark under the School Modernization Bonds proposal
for renovations and repairs to Indian schools
--$175 million for Indian Head Start programs
--$460 for bilingual education including Native language instruction
materials.
Our community of 11,000 is comprised of Pinon and seven other
Chapters of the Navajo Nation. While we have made much progress in
recent years, our community suffers many of the same problems that
plague tribal communities nationwide. In 1990, more than one-third of
all Indian children ages 5 to 17 were living below the poverty level.
The high school completion rate for Indians ages 20 to 24 is 12.5
percent below the national average. The problems we face are deeply
entrenched and will not change overnight, but your full support for
budget increases in the areas listed above will represent a critical
step toward empowering tribal schools in our efforts to confront and
reverse these troubling statistics.
department of education
Indian Education.--The Administration's request for $115.5 million
for Indian Education in fiscal year 2001 represents an important step
toward addressing long-time shortfalls in this area. We urge you to
fully support this request and related funding to benefit educational
efforts in Indian Country.
We strongly support the Administration's fiscal year 2001 request
for $92.8 million in Grants to LEAs for activities to improve the
educational achievement of Indian students. The proposed budget also
contains $20 million for Special Programs for Indian Children, a much-
needed increase for which we also ask your full support.
American Indian Teachers and Administrators.--We are particularly
excited about the Administration's request for funding to recruit,
train, and provide in-service professional development for American
Indian teachers and administrators. In support of the President's 1998
Executive Order on Indian Education, the proposed budget includes $10
million for continuation of the Indian Teacher Corps program and a new
$5 million initiative to create an American Indian Administrator Corps
to recruit, train, and provide professional development for American
Indians in the field of school administration. We strongly support this
request.
head start
A critical element in any effort to raise the academic achievement
level of students in Indian Country must be high-quality early
childhood education programs. There is overwhelming evidence that
programs like Head Start lay the groundwork for developing effective
learning skills that can have a lifelong impact on a child's education.
Therefore, we urge the Subcommittee to take the following actions with
respect to Head Start:
--Fully fund the Administration's fiscal year 2001 budget request of
$6.3 billion for the Head Start program, including at least the
requested level of $175 million for Indian Head Start programs
--Prioritize the construction of badly-needed tribal Head Start
facilities; and,
--Encourage the Department of Health and Human Services (HHS) to
allow tribal organizations to administer Head Start programs
under Public Law 93-638 self-determination contracts.
Program Access for More Eligible Children.--At the Pinon Community
School, we see regular, concrete evidence that children who have
attended Head Start are more prepared to learn when they graduate to
our school. Unfortunately, the current funding level does not allow us
to serve all of our area's Head Start-eligible children. The Pinon Head
Start program serves 20 children, plus another 30 children though home-
based instruction. That said, at least 391 children are eligible for
comprehensive Head Start services, but we lack the funding and
facilities to expand our program. They are falling through the cracks,
and there is no second-chance at these critical learning years.
We want every child in our community to have the early educational
attention they deserve. We strongly support the Administration's long-
range goal of increasing Head Start enrollment to one million. If the
Subcommittee fully funds the Administration's fiscal year 2001 budget
request of $6.3 billion, nearly 950,000 children can be reached by Head
Start, and 54,000 toddlers could reap the benefits of Early Head Start.
These are not just numbers, they are each individual lives being
shaped, someone's child that will have a better chance at fulfilling
their dreams in life. We ask your support for these children at the
onset of their educational journey.
Replacement Facility Construction.--Without funding to build new--
and safe--facilities, the goal of increasing Head Start enrollment to
one million will be meaningless to Pinon. Currently, our Head Start
program is located in a 20-year-old classroom that only accommodates 20
students. In order to expand services to even a fraction of the 391
children who are eligible for Head Start in our area, we will need an
additional building. Other areas suffer similar facilities constraints
on their programs. We ask you to allocate a specific portion of the
fiscal year 2001 Head Start appropriation for facility needs to break
down this barrier to access for additional eligible children.
Tribal Administration of Local Head Start Programs.--Section 102 of
the Indian Self-Determination Act (Public Law 93-638) directs the
Secretary of Health and Human Services (HHS) to contract with tribes to
operate federally-funded programs for their members. DHHS, however, has
interpreted this provision narrowly to require contracting only of
programs ``operated for the benefit of Indians because of their status
as Indians.'' Thus, only Indian Health Service programs are deemed
contractible by DHHS.
We would like to be able to contract to administer Head Start
programs as a direct grantee under the American Indian Programs Branch
of the Head Start Bureau. The Pinon Community School Board has
successfully contracted education programs since 1988 and has
continually improved student services during this time period. The
Board believes that administering a tribal Head Start program through a
self-determination contract would be beneficial to the community and
the participating children. It would decrease the amount of federal
bureaucracy that we must navigate by allowing us to receive all of our
funds directly from Head Start using one funding document and would
give us the flexibility to run our local programs to meet local needs.
Currently, we receive our funding from the Chinle Agency, which in turn
receives the funding through the Navajo Nation, Division of Dine
Education, Department of Head Start.
We ask you to consider including report language in the fiscal year
2001 LHHS-Ed Appropriations bill that would encourage the Secretary to
work with tribes to fully implement the Indian Self-Determination Act
so that tribal organizations may contract Head Start.
bilingual education
We urge your Committee to provide the full $460 million requested
for Bilingual and Immigrant Education. In addition, we ask that you
take steps to ensure funding within this budget for the dissemination
of instruction materials in Native languages.
In 1994, Congress authorized the Secretary of Education to provide
grants to develop, publish, and disseminate instructional materials in
Indian, Native Hawaiian, Pacific Islander, and outlying territories
languages. This program has never been funded. We urge the Subcommittee
to include report language instructing the Secretary to allocate fiscal
year 2001 funding for this purpose.
At Pinon, 86 of our students are considered to have Limited English
Proficiency. It is our goal to provide these children with
comprehensive bilingual education so that they can learn English and
meet challenging academic standards while maintaining a knowledge of
and respect for their native language. To meet this goal, it is
critical that we have funding to train personnel and develop innovative
bilingual education programs at the local level.
conclusion
Thank you for considering our concerns and comments. The Pinon
Community School appreciates the funding that the Subcommittee has
provided in the past to programs of concern to our school, and we look
forward to your continued support.
______
Prepared Statement of Elmira College, Elmira, NY
Mr. Chairman, thank you for this opportunity to submit testimony
for the record regarding Elmira College's proposed Technology
Enhancement Initiative.
Today, unlike any other time in history, we have a substantial
opportunity to apply the information age technologies to schools that
are so effective outside the classroom for educational purposes. For
schools to make the most of this opportunity, they must rethink
education from the ground up.
The power of information technologies to reshape education is
already becoming unmistakable. In scattered locations around the
country, schools are using state-of-the-art technologies and
interactive multi-media to engage students more actively in learning
and to teach them skills they will need to thrive in an information
based workplace and world. This is particularly true with non-
traditional students who have little if any access to traditional
classrooms and educational services.
As information age infrastructure is developed, more and more
students and teachers will gain access to a global web of information
and exchange ideas, services and education globally.
The Internet and other information technologies are bringing
interactive instruction to schools in our cities and suburbs.
Importantly, the past several years have witnessed a stronger focus on
providing those information technologies in rural areas of the country.
These technologies are allowing students to build ``communities'' with
their counterparts around the world and create lifelong beneficial
links between schools and the communities around them.
Taking advantage of this new capability will require profound
changes in the roles of teachers, students and schools. Instead of
being the repository of knowledge, teachers will be guides who will
help students navigate through electronically accessible information.
They will use the new technologies to build networks with each other,
with parents and students, with academic and industrial experts and
with other professionals.
In order to ensure that students (K-12, undergraduate, graduate,
continuing education or professional development students, students in
rural areas) receive the full potential of the technology age, the
technological access must exist in flexible locations and provide
continuous access to their extended communities. Equally as important,
teachers must receive extensive training in how to use existing and
emerging information technologies and how to design and implement
appropriate curricula for a state-of-the-art 21st Century classroom.
To make technology a viable instructional and professional
development tool requires schools to have enough computers to provide
full easy access for all students including students with disabilities.
Institutions of higher education are central to the national effort
to ensure that all students and teachers are equipped to take full
advantage of the technology era. By providing education, training, and
technical assistance these institutions can work in partnership with
local school districts, human service agents and professionals to
address problems associated with the rapid onset of the information
age, including: educational, economic and social infrastructure of
their surrounding communities.
Elmira College is an institution of higher education that accepts
that responsibility willingly, recognizing the benefit to its students,
students in surrounding school systems and community colleges, and
individuals in nearby communities in need of continuing education or
professional development. As such, it is implementing its ``Technology
Enhancement Initiative'' to address its own and regional educational
and technology training needs.
the ``technology enhancement initiative'' at elmira college
As it approaches the 21st Century, Elmira College, in Elmira New
York, stands at an important crossroads in the development and
expansion of its educational resources. To ensure its continued
strength as a four-year institution of higher education the College is
proposing the implementation of its ``Technology Enhancement
Initiative'' to relocate and improve its technology infrastructure.
This initiative will address the ever-growing need in the southern
tier of New York and northern tier of Pennsylvania for access to higher
education, teacher technology education and training and professional
development services. It will provide the College the opportunity to
expand its technology resources and to meet its own and regional
technological and services demands.
Elmira College proposes to establish a partnership with the Federal
Government that will:
--Relocate, consolidate and improve all student and administrative
computing services from McGraw Hall, which is handicapped
inaccessible, to the Gannett-Tripp Library which is handicapped
accessible;
--Upgrade existing ``hub'' hardware to state-of-the-art technology
which will be able to meet and manage the demands of the
upgraded system; and,
--Wire every dormitory, classroom and administrative meeting room as
well as every faculty, academic, and administrative office
building for direct access to the Gannett-Tripp Library, the
Steele Memorial Public Library and an interface with the local
public library system and with the Internet.
As a result of the improvement to its technological infrastructure,
Elmira College will have the opportunity to expand existing and
implement several new educational and training programs in partnership
with local school systems and human service agencies. Specifically, the
initiative will enable the College to:
--Offer access to higher education courses in 12 rural and
underserved counties and 21 K-12 school districts (58,308
students), 8 community colleges and a variety of community
sites via distance learning;
--Offer access to Elmira College library resources, including the
federal depository at the College, at a variety of community
sites via distance learning to underserved counties;
--Provide teacher technology education and training both on and off
campus;
--Provide expanded professional development and technology education
and training services;
--Provide leadership and technical assistance to local K-12 systems
in the development of state-of-the-art technologically advanced
classrooms and prepare its Education students (future teachers)
and regional teachers to teach effectively in this
technologically advanced era.
In addition to the obvious educational benefits that the Elmira
College ``Technology Enhancement Initiative'' will have for the College
and its students, there are several significant benefits for teachers
in the regional community.
As a result of the Technology Enhancement Initiative, Elmira
College will have the opportunity to work in partnership with regional
school systems to address the education and training needs of their
teachers and staff.
Elmira College will work to identify technology education and
training expertise in the region and the nation and work with local
school districts to develop critical professional linkages needed for
the local school system to take full advantage of that expertise for
their students.
In addition, as part of its own curricula, Elmira will provide
expanded in-depth technology education and training for students in its
Masters of Education programs.
The Technology Enhancement Initiative will provide Elmira College
the ability to offer these teacher education and training courses
through any of its distance learning capabilities to teachers in the
classroom, on-site at their own schools, at local libraries, community
colleges or even in the home. Graduate students at Elmira will continue
their training within the local schools, but will have an increased
ability to conduct classroom observations, information exchanges and
training as a result of the Technology Enhancement Initiative.
To do so, the College will expand existing and implement new
education, training and professional development programs, including
courses such as Computers in Education, Interactive Media for
Educators, The Internet for Educators, Video Production for Educators,
and Microcomputer Applications for Educators. Finally, it will provide
the College with the opportunity to play a leading role in improving
the social and economic infrastructure of the region.
The Technology Enhancement Initiative will create an expanded
opportunity for cooperation in the provision of higher education
courses between Elmira College and local community colleges. It will
help those institutions to provide timely and relevant programming at
the same time it helps to prevent unnecessary duplication of academic
programs and/or courses at Elmira or the community colleges.
As it is proposed, the relocation, expansion, and consolidation of
all computing functions at Elmira College will provide three methods of
distance learning in the future, including:
--Computer Based Research
--Internet Conferencing
--Compressed Video
Students and professionals in the field will have the ability to
access education, training or professional development from home (if
the connection exists) from libraries, other designated community sites
or from any of the eight sites where Elmira currently provides minimal
programming including:
--Bath
--Corning
--Ithica
--Owego
--Penn-Yan
--Watkins Glen
--Rome
--Syracuse (adult education)
Elmira College will have the ability to share faculty experiences
across institutions and establish partnerships on select courses with
regional community colleges, including general education courses,
courses to support selected major requirements, and coursework
providing a valuable supplement to existing offerings. Elmira College
currently holds articulation agreements with three regional community
colleges that will be expanded as a result of the Technology
Enhancement Initiative. Those institutions include:
--Tompkins Cortland Community College
--Corning Community College
--Broome Community College
To enable the completion of this important initiative, Elmira
College is seeking $3,399,000 million in federal support. To date, the
College has invested $500,000 in campus infrastructure in preparation
for the implementation of this initiative (these dollars are not
counted as part of the official project cost, but are calculated into
the College's contribution). The College is firmly committed to the
completion of the project and the implementation of this important and
enabling technology infrastructure and therefore will contribute an
additional $1 million towards the total cost of the initiative. Total
project cost is $5,923,680 million.
Mr. Chairman, this initiative is critical to the long-term economic
viability of Elmira College as well as the regional the K-12,
undergraduate, graduate, continuing education and professional
development systems in the southern tier of New York and the southern
tier of Pennsylvania. We look forward to working with you to secure the
final phase of funding for this very important initiative in fiscal
year 2001.
Again, thank you for the opportunity to present this testimony for
the record.
______
Prepared Statement of the Northwest Regional Educational Laboratory
My name is Dr. Ethel Simon-McWilliams, and I am the CEO and
Executive Director of the Northwest Regional Educational Laboratory
(NWREL), in Portland, Oregon. I take this opportunity to share with you
the need for trained Retired and Senior Citizen Reading Tutors; and, a
program that the NWREL has proposed for training these citizens so that
they can serve more effectively as reading tutors for children, youth
and adults.
America now enjoys not only the largest and fastest-growing group
of older adults in our history, but the healthiest, most vigorous, and
best educated. According to a 1999 survey of older Americans, engaging
in community service is an important part of the retirement plans of
most seniors. More than half of older Americans polled have volunteered
within the past year in their communities, and working with children
and youth has been a top priority for their time and talent.
At the same time, school districts are struggling to meet the needs
of low performing students to increase their reading achievement. Local
school districts across the nation are faced with restricted budgets,
larger class sizes and reduced services for students with special
needs. Thirty-eight percent of fourth-graders read below basic level
and lack even partial mastery of reading skills needed for proficient
grade-level work. By 12th grade, 23 percent of students remain below
basic level. These struggling readers are disproportionately from
families living in poverty.
The experience of the federal America Reads Challenge in 1998 and
1999 clearly showed that adults who are effectively prepared to be
reading tutors can have a positive effect on students' achievement. The
Northwest Regional Educational Laboratory has provided a range of
supports to volunteer service programs since 1995, and in 1998-1999 was
selected by the Corporation for National Service as the national
provider of training and technical assistance to education-focused
senior programs. The Northwest Laboratory examined reading tutor
programs across the country and found, among other things, that the
success of a tutoring program rides on the abilities, energy, and
commitment of its volunteer tutors, as well as a strong school capacity
and support for tutors.
One-on-one tutoring is clearly shown to be the most effective use
of retired and senior volunteers. Senior tutors provide children with
an important caring adult and an intergenerational presence that is
often missing in today's mobile society.
Our research shows that volunteers are more likely to continue
volunteering if they feel that their efforts are well-utilized. Well-
trained senior volunteers, armed with research-based skills and
strategies, offer an important boost toward helping children learn to
read and gain academic and social success.
There are many successful tutoring programs in schools across the
nation. We know with some confidence the elements of these programs
that make them successful, or on the other hand, what lacking elements
cause them to be less successful.
Therefore, I urge the support of a demonstration program, funded
through the U.S. Department of Education's Fund for the Improvement of
Education (FIE), that will validate the combination of elements of a
model tutoring program that effectively taps the human resource pool of
senior citizens. At the same time, such a demonstration project will
result in the necessary resources to assist and guide states and
schools across the nation implementing the model: a guide for statewide
implementation for use by state education agencies, a tutor training
package, and a project resource kit for schools. The Northwest Regional
Educational Laboratory has the unique combination of experience and
capabilities in technical assistance to school-based tutor programs,
training of seniors as tutors, and evaluation of effectiveness of tutor
programs to conduct this demonstration program in collaboration with
school districts and senior volunteer organizations in Alaska, Oregon,
and Washington.
Our analysis of 61 effective volunteer reading tutoring programs
across the country has shown that, to be successful, they must have:
--A clear definition of the roles, responsibilities, and
accountability
--A plan for sustainability and capacity building
--A pro-active, well-qualified program director and an effective
advisory committee
--Strong school and teacher commitment
--Effective and sustainable tutor recruitment
--Access to groups of tutors via universities, civic organizations,
businesses, etc.
The operation of effective senior reading tutor programs needs to
include:
--Consistent onsite supervision of tutors
--Tutoring sessions that support district curriculum and classroom
instruction
--Tutor commitment
It is critical that tutor training be provided, based on a clearly
defined, research-based training model. Training must accommodate
tutors' varying expertise, learning styles, and schedules, and ongoing
training and onsite support should include: (1) tutor consultations
with a seasoned tutor, reading specialist, or teacher; (2) support and
guidance for tutoring session planning; and (3) recognition and
appreciation of tutors. Reading tutor programs must utilize high-
quality materials, including a program-specific handbook and resource
library for tutors, tutor-training manual, materials that support
school standards, and record-keeping and assessment tools.
The benefits of effective tutoring programs in schools is well
documented. In general, tutoring:
--Increases students' mastery of academic skills
--Improves self-esteem and self-confidence
--Improves students' attitude toward school and reduces dropout
rates, truancies, and tardies
--Breaks down social barriers and creates new friendships
--Adds emotional support and provides positive role models
It is also clear that seniors who are tutors receive: (1) a sense
of pride and accomplishment for having helped someone else, (2)
increased self-esteem, confidence, and sense of adequacy as a result of
being a tutor, (3) new or increased sense of responsibility and
awareness for what teachers must do to transmit knowledge to students,
and (4) empathy for students for whom learning may be much more of a
struggle.
The Northwest Regional Educational Laboratory has trained senior
program staff in supporting and training reading volunteers, reading
tutoring strategies, and partnering effectively with schools. Utilizing
these experiences and capabilities in conducting a demonstration
program on seniors tutoring students in reading with federal support
provided by the U.S. Department of Education's Fund for the Improvement
of Education will be an important step to implementing effective senior
tutoring programs in schools across the country.
I urge the Members of the Subcommittee to provide $1,000,000 in the
fiscal year 2001 Labor/HHS/Education Appropriations bill for the
Northwest Regional Educational Laboratory to carry out this program to
train Retired Senior volunteers in Oregon, Washington and Alaska to
serve as reading tutors in the most needy schools according to reading
scores. The resulting model will be shared with other states.
Thank you for your affording me this opportunity to share the
details of the NWREL's proposed retired and senior tutor training
demonstration project.
______
Prepared Statement of the Federation of Behavioral, Psychological and
Cognitive Sciences
Mr. Chairman, members of the Subcommittee, my name is Patrice
O'Toole. I am the Assistant Director of the Federation of Behavioral,
Psychological, and Cognitive Sciences. I am testifying today on behalf
of the scientific societies that comprise the Federation, the American
Psychological Association, the Society for Research in Child
Development, and the Consortium for Social Science Associations. Our
organizations represent most of the scientists who carry out the
nation's educational research and many of the scientists who carry out
its health-related research. My testimony will, therefore, be directed
at the funding requests for those two areas of research.
I want to begin by thanking Senator Specter for his support and
efforts on behalf of the scientific community. During his entire tenure
in Congress, Mr. Specter has been a champion of biomedical and
behavioral and social science research. The American people are
healthier today because of the basic and applied research Mr. Specter's
work has made possible.
office of educational research and improvement
The Office of Educational Research and Improvement has been
profiting from the leadership shown by Assistant Secretary Kent
McGuire. The quality of peer review, which has been a concern both to
Congress and to the scientific community has increased markedly, and
further strengthening is taking place. Dr. McGuire has been giving
direction and form to the initiatives of OERI. We are particularly
pleased that the second round of proposal solicitations for the
Interagency Education Research Initiative has just begun. One of the
problems in educational research has always been that there has not
been enough money to carry out research on large-scale applications.
The combined funding of OERI, the National Science Foundation, and the
National Institute of Child Health and Human Development is helping to
make such research a possibility. The funds available even from three
sources hardly approaches the funds that go into clinical trials of new
pharmaceuticals, but this program is a big step in the right direction.
As you know, NICHD was not able to contribute funds to the first round
of grants. NICHD's requested funding for this effort for fiscal year
2001 is still less than that contributed by the other partners. We ask
that NICHD's contribution be raised to $20 million to make it an equal
partner in this important undertaking both in terms of intellectual
effort and in terms of funds.
NICHD and OERI are also cooperating in an initiative to identify
the factors that lead to acquisition of English reading and writing
skills for children whose first language is Spanish. The statistics
that reflect the difficulty Spanish speaking children encounter in
school are well known. We think the OERI/NICHD partnership to improve
this situation are to be welcomed and fully supported.
We also believe OERI is on track with its implementation of
Comprehensive School Reform Demonstrations and its general effort to
measure the impact of school reforms. It has so often been the case in
education that new approaches are implemented with little concern for
the research base supporting them and even less concern about
evaluating outcomes. There are some positive signs that OERI is helping
to change that, and these efforts need to be encouraged.
Before the last reauthorization of OERI, one of the most glaring
omissions from OERI's research programs was a robust program of field-
initiated research. We have been delighted to see the gradual change
that has occurred over the years of the current authorization. From
less than $1 million before the reauthorization, the field-initiated
research program has grown to about $15 million. It is a small amount
when compared to the amounts NSF, and NIH spend on research whose
subject matter has been determined by researchers rather than by
federal directives, but again, the steps have been in the right
direction.
While we believe that much more emphasis is needed on basic,
applied, and development research to improve teaching and learning, we
are strongly supporting the requested $30 million funding increase for
research and statistics by OERI. Space does not permit a thorough
treatment of the value of the statistics gathering work of the National
Center for Education Statistics. It is this work, however, that tells
us enough about teaching, learning, and their lifelong effects to make
it possible to devise evidence-based public policies that address real
problems in effective ways. These statistics have been valuable
precisely because they are measures of the state of education and
learning. We have been concerned for years that NCES has been brought
into the effort to design national tests. Our concern has been and
remains that NCES's involvement in development of high-stakes testing
will undermine the ability of NCES to be perceived across the nation as
an objective, impartial evaluator of the state of education in the
country. There is room to debate the wisdom of national tests. It is
unfortunate, however, that we have been unable so far to keep that
divisive issue from endangering the ability of NCES to keep its finger
on the nation's educational pulse.
Finally with respect to OERI, we are disturbed that the Department
of Education has chosen to present its request for OERI research
programs as a single line item, a move that is consistent with the
design for OERI being proposed in OERI's reauthorization draft, but
that is inconsistent with the current structure. There are items of the
proposed reauthorization with which we take issue. We support the
overall request, but note that it is out of place to make assumptions
in the budget presentation about the future structure of OERI before an
authorization has been passed in either house.
national institutes of health
The administration is requesting a $1 billion increase this year
for the National Institutes of Health (NIH). This would increase NIH's
budget to nearly $19 billion. This is an increase that is substantially
lower than needed to stay on track to doubling the research budget over
five years. We are asking Congress to stay on track toward doubling the
budget by increasing the budget by 15 percent which would bring the
fiscal year 2001 budget to $20.5 billion. Beyond the expressed
commitment of many in Congress to accomplish this doubling, we also
base our recommendation on several observations.
(1) Fulfilling NIH's priorities for fiscal year 2001, which include
increased attention to health disparities research, requires the
increased funding. (2) Solid funding has increased the pace of
discovery across the health sciences, and nothing should slow that
momentum. (3) Health care costs have become unbearable for millions.
The best way to control those costs is to keep people healthy. The
ultimate purpose of health research, including health research in the
behavioral and social sciences, is to make the citizens of this country
healthier throughout their life span.
Let me mention just a few of the uses to which the funding increase
would be put.
NIH has established a working group, led by NIH Acting Deputy
Director Yvonne Maddox and National Institute of Allergy and Infectious
Diseases Director Anthony Fauci, to examine health disparities. In
addition, NIH's fiscal year 2001 budget contains a request for $20
million to establish within the Office of Research on Minority Health
(ORMH) a Coordinating Center for Health Disparities. We support this
request.
The Human Genome Project is expected to complete human gene
sequencing by this summer. Already NIH has been at the forefront of
research in genetics and neuroscience. That research is helping us
understand many diseases including Parkinson's, Alzheimer's, drug
addiction and diabetes. With sequencing nearing completion, we are
poised for an explosive growth in discoveries in the years ahead.
Scientific advances in knowledge about brain disease have been
possible because of new methods for the study of the nervous system,
such as neuroimaging. Identifying the molecules that guide the
formation of the brain and increasing understanding of how the
processes occur are allowing neurobiologists to visualize how the
developing nervous system organizes itself, to explain complex
behaviors, and to describe neurological and psychiatric diseases with a
new level of precision. However, equally important is the role that
behavioral, psychological, socio-cultural, and environmental factors
play in health. Our beliefs, our emotions, our behavior, our thoughts,
our family and cultural systems, our socio-economic status, as well as
the environmental context in which we live, are all as relevant to our
health as our genetic inheritance and our physiology.
The emergence of cross-disciplinary collaboration has been a major
component in the fast-paced research developments in these arenas.
Across the NIH-supported sciences, the growing tendency for scientists
from many disciplines to come together to solve research problems has
shown significant results.
AIDS has not been cured, but research has shown how a mixture of
treatments can ward off the worst effects of AIDS, for many years.
These treatments involve the use of a variety of drugs in combination
and they involve a demanding level of discipline on the part of the
patient to take the medications properly--a discipline that can be
trained by application of techniques developed through behavioral
research.
Similarly, recent NIH-supported behavioral research has produced
useful new knowledge, including a better understanding of basic
behavioral and social processes and how they interact with biological
processes. This understanding is coming from many lines of research:
studies of lifestyle choices, dietary habits, the desire and ability to
maintain exercise or medication regimens, psychological functioning,
and influences of one's social and cultural environment on behavior.
All these lines of research converge to give us a picture of the
factors that can affect an individual's ability to remain healthy or to
recover from disease or to function well despite a chronic condition.
And that knowledge leads to treatments and other interventions to
maintain health throughout the life span.
NIH's Office of Behavioral and Social Sciences Research (OBSSR),
created in 1995 has been pivotal in supporting these studies and
translating the findings into effective prevention and treatment
strategies. OBSSR, under the purview of the Office of the Director of
NIH, coordinates all the institutes and centers in marshaling their
individual resources to collaborate on behavioral and social sciences
research. OBSSR's congressionally mandated primary mission is to foster
the development of cross-disciplinary communication and research
collaboration among behavioral and social sciences and between the
behavioral and social sciences and biomedical sciences.
OBSSR, under the auspices of its first Director, Norman Anderson,
has achieved great success in its short existence. We believe it can
accomplish a great deal more with the continued support of Congress and
the necessary resources to do so. A key role for OBSSR has been
assuring that development of effective behavioral interventions is
keeping pace with technological advances.
OBSSR has been successful, yet continues to operate with a small
staff and a small budget. Last year, Congress approved a $7 million
increase for OBSSR to continue its efforts to encourage cross-institute
collaboration and research in the behavioral and social sciences. This
money is being used to fund a trans-NIH initiative on adherence to
medical and behavioral interventions across a number of diseases and
conditions. OBBSR is also funding a trans-NIH initiative seeking
effective interventions to curb youth violence. And as episodes of
violence between children mounts, the need for these programs is
critical to reducing the overall level of violence. More research is
needed on children and youth at risk. We need a richer understanding of
the social, environmental, psychological, developmental and biological
factors involved in risk as well as a deeper understanding of how the
factors interact.
Despite the pressing need for this research, the President's
request for fiscal year 2001 provides no increase for OBSSR's budget.
OBSSR's current budget is $19.86 million. The Federation supports an
increase of ten percent for OBSSR, bringing its budget to $21.84
million for fiscal year 2001. This increase would significantly augment
OBSSR's ability to continue coordinating research across institutes.
This is an efficient use of resources and a beneficial mode of
operation, because it links areas of related knowledge that might
otherwise remain separated.
A prime example of benefits of behavioral research has been the
identification of factors that aid in protection from disease and that
promote recovery from illness. They include certain personal attributes
such as optimism, effective strategies for coping with stress, and
meaningful sources of social support and affiliation.
NIH funding has permitted us to use research wisely, that is, in
the combinations that will be most efficient in reaching solutions to
typically multifaceted health problems. To continue successful
biomedical and behavioral research at this level requires Congress'
ongoing commitment to finding resources for expanding NIH's budget.
With increased support, the current pace of discovery and
collaboration can be sustained. The largest per person expenditures for
health care occur near the end of life. One goal of research is to
understand what interventions through the life span will have the
greatest promise of assuring that the period of great illness before
the end of life is minimized. As more of the U.S. population reaches
advanced age--the number of Americans aged 65 and older is expected to
double by the year 2030 to nearly 68 million--it becomes increasingly
vital to the health of our entire society that we age well. Many of the
problems that accompany aging, especially chromic diseases, stem from
behaviors that place individuals at risk of negative outcomes.
The National Institute of Child Health and Human Development
(NICHD) conducts research on human growth and development from
conception through birth, infancy, childhood, adolescence,
reproduction, and through maturity to old age. As such, NICHD addresses
some of the most important health and development problems facing our
children and families.
Based on this broad spectrum of research, we believe that NICHD's
fiscal year 2001 budget should be increased by 23.9 percent, bringing
its budget to $1,064,800. Historically and chronically, NICHD has been
one of the lowest funded institutes even though it conducts research
that has immediate, proven and successful applications through
behavioral intervention. We urge the subcommittee to press for higher
funding of NICHD.
Behavioral research has a large role to play in contributing to the
nation's health, because controllable choices and behaviors in life
have a heavy impact on the quality of life. Obviously, such behavioral
choices as to smoke or not to smoke, what foods and quantities of food
to consume, and how regularly one exercises are among the most
important choices we make in determining our health. But each of us
knows how difficult it is to do the right thing.
Behavioral researchers in cooperation with nutritional researchers,
neuroscientists, epidemiologists and a host of other specialists are
working to find ways to make it easier for people to make the right
choices about their health. The payoff for finding solutions to these
problems will be not only a healthier population, but also the
shrinkage of health care costs to a manageable size without sacrificing
the well-being of the country's citizens. Through research it is
becoming possible to maintain good health and keep health care costs
down at the same time.
We strongly urge the Subcommittee to recommend a 15 percent
increase for NIH because the investment in knowledge will result in
healthier citizens and health care cost savings that far exceed the
research investment. Slighting research will assure that rising health
care costs will remain among our most serious national crises.
We thank the Subcommittee for the opportunity to present our views.
______
Prepared Statement of the United Negro College Fund
Mr. Chairman and Members of the Subcommittee. My name is William H.
Gray, III and I am President and Chief Executive Officer of the United
Negro College Fund (UNCF). I thank you for the opportunity to bring
UNCF's fiscal year 2001 recommendations for higher education programs
before you.
UNCF is America's oldest and most successful black higher education
assistance organization, representing 39 private, four-year
historically black colleges and universities with either independent or
religious affiliations. UNCF has been committed to increasing and
improving access to college for African Americans since 1944. The
organization remains steadfast in its commitment to enroll, nurture,
and graduate students who often do not have the social and educational
advantages of other college bound populations.
Since its inception, the fundamental mission of UNCF has been to
raise critical operating funds for member institutions and their
students, faculty, and staff. Mr. Chairman, I am proud to say that over
the years, this mission has broadened to include over 450 successful
scholarship programs, internships, research and study abroad
opportunities for all historically black colleges and universities
(HBCUs), Hispanic-serving institutions (HSIs), Tribally-controlled
colleges, and majority institutions. We also provide technical
assistance to our trustee programs such as the fiscal and strategic
technical assistance program (FASTAP) and faculty training, for
institutions both domestic and abroad.
UNCF is committed to educating tomorrow's workforce. America's
markets are growing more diverse, and demographic trends indicate that
early in the 21st Century, African Americans and other racial and
ethnic minority groups will constitute a major part of the workforce.
The more than 55,000 students enrolled at UNCF institutions are
from diverse backgrounds. Our schools mirror the mosaic that is
America; we are African American, White, Hispanic, Asian, and Native
American. While our student body consists of varied economic
backgrounds, approximately 34 percent of all UNCF students come from
families with incomes below $25,000 (compared with 17 percent of
students attending four years colleges nationwide). Approximately 90
percent of UNCF students require some form of financial assistance.
Forty percent are the first in their families to attend college
compared with the national average of 35 percent.
In spite of these challenges, UNCF students and members
institutions have accomplished much. They are noted for their
consistent standards of excellence and outstanding achievements. HBCUs
are the major source of African American college graduates and black
professionals in America. In fact, 16 Members of Congress are alumni of
HBCUs. HBCUs contribute significantly to the production of African
American baccalaureate degree holders in the sciences. HBCUs also
graduate the most African American doctoral degree recipients. In
addition, more than 50 percent of the nation's African American public
school teachers and 70 percent of African American dentists and
physicians earned degrees at HBCUs. These are but some of the
extraordinary roles HBCUs have played in educating minority Americans.
Mr. Chairman and Members of the Subcommittee, the impressive
achievements that I noted have an even greater significance at UNCF
institutions in that our schools have accomplished all this for a
fraction of the cost compared to that of majority institutions. The
average cost of attending a UNCF institution in 1997-1998 was $13,368,
which is substantially below the average cost of $21,424 at four-year
private colleges nationwide. In fact, UNCF's tuition increased only
43.5 percent over the last decade compared to a 51.6 percent increase
at all private, four-year colleges during the same period. However,
this cost still remains above the financial means of most of our
students and their parents. Furthermore, keeping the costs of a college
education down while educating ``at-risk'' students comes at a
financial price for UNCF member institutions.
Consistent with our commitment to providing access to higher
education to economically disadvantaged, first generation students, we
applaud federal efforts to make college affordable for all. As you
know, students from low-income backgrounds, when compared to all other
students attending four-year colleges and universities, are more likely
to drop out and less likely to earn a degree. In fact, according to a
recent survey of beginning postsecondary students released by the U.S.
Department of Education, 42 percent of students from the nation's
poorest families (with incomes less than $20,000) received a bachelor's
degree within five years while 35 percent--a significant portion of
similarly situated students--had dropped out entirely.
Additionally, students have increasingly turned to borrowing in
order to manage rising education costs. More full time undergraduate
students are also working while enrolled. The burden of borrowing and
working plays a significant role in how students pay for their
education and whether they graduate.
Clearly, students with adequate financial resources have an
increased chance of obtaining a degree over those without access to
similar means. However, most research on the subject indicates that
simply increasing financial aid to low income students does not appear
to have any particular significance in determining successful outcomes
(i.e., improving the chances of staying in college and graduating). We
know that a freshman or sophomore, low-income student may choose to
leave college rather than face the prospect of assuming loan debt. Mr.
Chairman, Congress should recognize that certain types of aid actually
serve as a disincentive for the nation's neediest students! Congress
should be mindful that what is important is the type of aid low-income
students receive; when it is given; and what other services are
afforded to them.
For these reasons, UNCF strongly supports increased student
financial assistance. Specifically we support the funding
recommendations of the Student Aid Alliance of which UNCF is a member.
Most important to our students is increased Pell Grant aid, preferably
awarded to a student in their earlier years of college, with a maximum
award of $3700 in fiscal year 2001. Moreover, we support the
Administration's proposal to enhance college persistence and completion
through the College Completion Challenge Grant. This is a new program
supporting a comprehensive approach to increasing minority retention
and completion rates through such activities as a pre-freshmen summer
program, support services, and increased grant aid to students. This
program would be funded at $35 million and operated under the
successful TRIO program, which UNCF also recommends receive an
increased $70 million in overall funding for fiscal year 2001. Other
student financial assistance programs we advocate higher funding for
are: SEOG ($731 million); LEAP ($100 million); Perkins Loans ($200
million); and the Federal Work Study Program ($1.1 billion).
Mr. Chairman, it is important to note, for the record, that growing
debate about making college affordable and providing a means to a
college education centers on the premise of providing tax credits for
students and their parents. Findings, however, support the position
that, while such tax credits benefit middle income and affluent
families, low-income families are better served by grant and
scholarship aid. UNCF firmly believes that a better of use of tax
dollars to achieve access to college would be to provide more grant
support in the manner that I recommended earlier.
In terms of institutional support, UNCF strongly recommends
increasing Title III, Part B, section 323 to $175 million and Title
III, Part B, section 326 to $40 million. These programs have been the
mainstay of UNCF schools through the years. For many UNCF institutions
in particular, Title III grants are the only form of institutional
assistance received from the Federal Government. These grants are used
for academic program enhancement, faculty development, student
services, and the construction, maintenance, and renovation of
buildings. We also support increases to the other institutional aid
programs under Title III.
Mr. Chairman, at a time when the education of tomorrow's workforce
tops agenda's nationwide, minorities are underrepresented in numerous
professions across the board--science, engineering, law, teaching.
Thus, UNCF strongly supports the Administration's proposed new Dual
Degree Programs at Minority Serving Institutions initiative that
addresses this very issue. This program complements existing curricula
at HBCUs and other minority-serving institutions and channels students
into careers in which minorities are underrepresented. Funding for this
new effort is $40 million. Several other programs provide critical
institutional support to UNCF member institutions that educate a
preponderant number of minority professionals while addressing these
shortages. Accordingly, UNCF recommends increases for these
initiatives, including the Minority Science and Engineering Improvement
Program (MSEIP) to $40 million, Title VI International and Graduate
Programs to $82.5 million (and the Institute for International Public
Policy/IIPP), the Thurgood Marshall Legal Education Opportunity Program
$5 million, and Teacher Quality Enhancement Grants to $140 million.
UNCF also stands firmly behind increased funding for the Department of
Education Office of Civil Rights at $78.605 million.
Minorities are also underrepresented in the international arena
while our country competes increasingly in a global marketplace. To
counteract this trend, UNCF believes Congress should increase its
support of IIPP to $2.5 million in fiscal year 2001. Currently,
entering its fifth year, IIPP will serve more minority students with
more programs than ever before. However, this program is increasing its
impact with only a 2 percent increase in its funding since the
program's creation in 1992. Surely, there is a need to have a diverse
cadre of international professionals in this global community.
Mr. Chairman, it is clear that UNCF member institutions leverage
federal dollars to the maximum potential. Even though we have smaller
endowments and a greater percentage of students needing financial aid,
UNCF institutions capitalize on our federal partnerships in
extraordinary ways to address national concerns. Currently, like the
rest of the nation, UNCF is facing the digital divide challenge, a
problem that is greater in higher education than it is among the
nation's households. A great many of the programs I have mentioned
today help us address this challenge--particularly the Minority Science
and Engineering Improvement Program. This important program provides a
critical resource for baccalaureate granting institutions like UNCF
member schools that miss out on the majority of federal dollars
allocated to science, engineering, and related areas, since funds are
traditionally targeted to majority research-performing institutions.
Consequently, our schools are hampered early on in their ability to
qualify and compete for funds--even though we contribute so much. For
this reason, it is imperative that Congress show leadership by funding
those proven programs that are designed to not only increase access and
opportunity for African American students and the HBCUs they attend,
but also those programs that have demonstrated a capacity to have
considerable impact on this nation's future.
Mr. Chairman, on behalf of the United Negro College Fund member
institutions, I thank you for the opportunity to provide testimony on
the fiscal year 2001 appropriations for higher education programs and
look forward to working with you to ensure strong alliances between our
schools and the Federal Government.
______
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.
Florida State University is a comprehensive Research I university
with a liberal arts base. The University's primary role is to serve as
a center for advanced graduate and professional studies while
emphasizing research and providing excellence in undergraduate
programs. Faculty at FSU have been selected for their commitment to
excellence in teaching, for their ability to perform research and
creative activities, and for their commitment to public service. Among
the faculty are numerous recipients of national and international
honors, including four Nobel laureates and eight members of the
National Academy of Sciences. Our scientists and engineers do excellent
research, and often they work closely with industry to commercialize
their results. Florida State ranks third this year among all U.S.
universities in revenues generated from its patents and licenses,
trailing only Columbia University and the entire University of
California system. Having been designated as a Carnegie Research I
University several years ago, Florida State University currently
exceeds $100 million per year in research expenditures. With no
agricultural or medical school, few institutions can match our success.
Florida State 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 192 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. At
Florida State University, we are very proud of our successes as well as
our emerging reputation as one of the nation stop public universities.
Mr. Chairman, let me tell you about a project we are pursuing this
year involving the U.S. Department of Education and distance learning.
Florida State University is pioneering the use of distance education to
provide access to baccalaureate degrees for students with Associate of
Arts degrees who, due to family or work situations, may not be able to
relocate to a college or university to complete their degree work. FSU
is currently offering three programs entirely on line for students to
receive their baccalaureate degree: Computer Science, Information
Studies, and Software Engineering. A new program in Social Science will
begin in Fall 2000 with other undergraduate programs to be developed.
This 2 + 2 program is being offered in cooperation with 18 community
colleges in Florida, which provide computer labs and proctored testing
facilities where needed. Florida State University's distance learning
initiative has focused not only on a quality course development model
based on that of the British Open University, but has placed a major
emphasis on student support for the distance education teaching and
learning environment. This ranges from having all major student
administrative services available on line, to partnering with
Blackboard, Inc. in the development of Course Info Enterprise Edition
for course development and delivery of courses. Students can do
everything on line from applying, getting their dial up e-mail account,
registering in courses, checking grades, to getting a copy of their
transcript.
But most important for student support and student success is our
use of mentors in addition to the faculty teaching the course. Mentors
take a proactive stance toward the students, contacting them on a
regular basis to see if they can provide help with any problems the
student is having, and are available electronically at any time to deal
with students questions and concerns. Student support is a key factor
in insuring student motivation to complete distance courses and do
well.
This program can be scaled up to constitute a model of effective
distance learning anywhere at the undergraduate level. Our focus has
been on Florida, though we have a small number of out-of-state students
in our distance degree programs. With additional support, more majors
can be added, and the program can be expanded to serve a wider range of
students geographically. Front-end development activities are essential
for quality courses and require significant expenditure to add majors,
train mentors and offer degree programs on a larger scale. Granting
such front-end funds will have a major pay off in terms of providing
access to a college degree to many place-bound individuals who
represent a significant and diverse part of our population.
Florida State as a research university is heavily invested in new
technologies and learning ideally positioned to provide further
leadership in student supported high quality distance learning. The
University was recognized in 1999 as one of the 100 most wired campuses
in America and the U.S. Department of Education has selected FSU as one
of its 15 demonstration projects on distance learning and financial
aid.
We are seeking an appropriation of $2 million within the Department
of Education's Higher Education account for this activity in fiscal
year 2001.
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 problems and 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 University of Tulsa
It is proposed that the Department of Education support an
information technology center for the University of Tulsa. We are
seeking $15 million for building and equipment needs.
the university of tulsa center for information technology
It is a reality that economies are increasingly linked to
technology. In February 2000, Oklahoma Governor Keating hosted a round
table discussion of technology, educational, and commerce leaders in
Tulsa. As a result of that meeting, a Center of Excellence in
Information Technology and Telecommunications was formed. Participants
in the Center include the University of Tulsa, Oklahoma State
University-Tulsa, the University of Oklahoma's Tulsa operations, Oral
Roberts University, Tulsa Community College and Tulsa Technology
Center.
The University of Tulsa is poised to help ensure that the Center of
Excellence in Information Technology and Telecommunications meets the
needs of industry and fulfills its mission of advancing the industry
through research and educational programs. However, we are in need of a
state of the art technology center to optimize our educational and
research opportunities.
There are a number of significant benefits that will flow to the
State of Oklahoma and the Tulsa community from an investment in a TU
Center for Information Technology (IT). These include:
--Attracting and retaining quality students
--Enhanced educational opportunities
--Research opportunities for both faculty and students
Attracting and Retaining Quality Students
TU is committed to quality education. The University of Tulsa
faculty is nationally recognized. For example, last year the Carnegie
Foundation honored two University of Tulsa professors for the
Advancement of Teaching and Learning. One was named a Carnegie
Professor of the Year and one was named a Pew Scholar. In the past five
years, The University of Tulsa, MIT and Stanford produced an equal
number of Goldwater Scholars, tying for seventh place in the nation.
The TU Center for IT would provide the infrastructure to maximize the
potential of integrating these quality students with quality faculty.
However, the Center would prove beneficial even before students arrive
on campus. The recruiting competition for quality students is fierce.
Students judge the technology infrastructure of a college or university
when selecting an institution of higher learning. Students often make
the decision to stay at a college or university based on opportunities
for access to state of the art technology. TU wants to educate the
technology knowledge workers to enter the digital economy work force
and the Center would allow us to nationally recruit quality students to
Oklahoma.
Enhanced Educational Opportunities
The TU Center for Information Technology will enhance educational
opportunities in three areas:
--by providing tools/resources to enhance learning in all academic
areas and disciplines,
--by providing an infrastructure for technology based program
students (such as management information systems, computer
information systems, and computer science) students to
complement in class learning by applying their classroom
learning, and
--by enabling TU to deliver education to a broader range of
constituents--students in divers geographic regions. It will
also enable TU to reinforce the lifelong learning we encourage
our alumni to pursue.
Research Opportunities
The TU Center for Information Technology will provide resource
opportunities for both University of Tulsa faculty, and graduate/
undergraduate students. Due to the number of industry leaders located
in Tulsa, TU researchers have access to a significant volume of
relevant subjects and data. TU's research program for undergraduate
students (known as TURC--the Tulsa Undergraduate Research Challenge) is
nationally recognized and acclaimed. Students have won a variety of
national scholarships and grants from prestigious organizations such as
the National Science Foundation and the Department of Energy. The
enhanced research labs available in the TU Center for IT would further
enhance the success of this program.
In summary, the combination of quality professor, students, and
technology infrastructure will result in a win-win proposition for
students of higher education in Oklahoma and the Oklahoma economy.
______
Prepared Statement of Fight Crime: Invest in Kids
Littleton, Paducah, Springfield, and Mount Morris. In the wake of
each of these tragedies, the American public has clamored for
solutions.
No one can say with certainty how each particular terrible tragedy
could have been prevented. But a great deal is known about how to
sharply reduce the incidence of school and youth violence. That is why
it is frustrating to those of us who represent law enforcement and
victims of violence when public officials wring their hands and pretend
they can do nothing to prevent the next tragedy. Law enforcement is
virtually unanimous about the steps that can help prevent future
incidents, and have issued a 4-point School and Youth Violence
Prevention Plan that calls on public officials to:
--Assure all kids access to after-school programs that connect them
with caring adults during the peak hours of violent juvenile
crime;
--Assure all families access to quality early childhood development
programs;
--Prevent child abuse and neglect and help heal those who have been
abused and neglected;
--Assure that troubled kids get early, effective help.
Our members, more than 700 police chiefs, sheriffs, prosecutors,
leaders of police organizations, and crime survivors, know that this
committee's decisions will have a profound impact on juvenile crime
rates in the years to come.
As a first step towards implementing our School and Youth Violence
Prevention Plan, we urge that you provide for fiscal year 2001 at
least:
--$6.3 billion for Head Start, so that the program can expand to
serve more eligible children, and further strengthen its
quality.
--$2 billion for an Early Learning Trust Fund so communities can fund
parenting-education programs and quality child development
services to children under five.
--$7.5 billion for the Child Care and Development Block Grant,
maintaining appropriate set-asides for quality, infants and
toddlers, school-age care, and resource and referral agencies.
The discretionary portion of these funds should be increased by
at least $818 million to be made available October 1, 2000.
--$1 billion for the 21st Century Community Learning Centers to
expand after-school programs that provide constructive
activities and connect kids with caring adults during the peak
hours of violent juvenile crime.
--$2.38 billion for the Title XX Social Services Block Grant. Recent
drastic cuts in this program have shortchanged child care (15
percent of state spending under the block grant), child abuse
prevention, removal and placement of abused children, drug
treatment, and other critical crime-prevention investments.
--$10.5 billion for Title I--Education for the Disadvantaged.
--$250 million for Title V of the Juvenile Justice Act for local
delinquency prevention programs.
Those on the front lines of the battle against crime know that
these investments are among our most powerful weapons against crime.
That's why over the last year, virtually every major national law
enforcement organization--including the Major Cities [Police] Chiefs
Organization, the Police Executive Research Forum, the National
Sheriffs' Association, and the National District Attorneys'
Association--have all adopted forceful calls for boosting critical
crime-prevention investments, such as educational child care and after-
school programs, preventing child abuse, and providing intensive
services to help troubled kids get back on track.
A recent poll of police chiefs conducted for Fight Crime by George
Mason University professors Scott Keeter and Steve Mastrofski showed
that nearly nine out of ten of police chiefs agreed that ``expanding
after-school programs and educational child care programs like Head
Start would greatly reduce youth crime and violence.'' Nine out of ten
agreed that if America fails to make greater investments in these
programs now, ``we will pay far more later in crime, welfare and other
costs.'' Police chiefs picked these investments as ``most effective''
in reducing youth violence by a margin of four to one over such
alternatives as trying more juveniles as adults or hiring more police
officers, and by seventy-to-one over installing more metal detectors.
Collectively, the four steps mentioned in our School and Youth
Violence Prevention Plan would dramatically reduce violent juvenile
crime. There are no substitutes for loving parents, but, government's
fundamental responsibility is to protect the public safety, and it
can't meet that responsibility by pointing fingers and saying parents
should do a better job.
The evidence is clear that well-designed programs for kids can
dramatically reduce crime and violence, and keep kids from becoming
criminals. But these programs remain so under-funded they reach only a
fraction of the youngsters who need them. For example:
--In a five-city study, half of a group of at-risk high-school kids
were assigned to participate in the Quantum Opportunities
after-school program. The boys left out of that program were
six times more likely to be convicted of a crime in their high-
school years. Yet roughly seven million youngsters under
twelve, and millions more teens, lack after-school programs
that put them in touch with caring adults providing supervision
and constructive activities.
--A High/Scope Foundation study at the Perry Preschool in Michigan
randomly chose half of a group of at-risk toddlers to receive a
quality Head Start-style preschool program, supplemented by
weekly in-home coaching for parents. Twenty-two years later,
the toddlers left out of the program were five times more
likely to have grown up to be chronic lawbreakers, with five or
more arrests. Yet inadequate funding for Head Start and the
Child Care Development Block Grant leaves millions of at-risk
children without critical early childhood services.
--A Montreal study showed that providing disruptive first- and
second-grade boys with social skills training and counseling
cut in half the odds that they would later be in special
classes, rated highly disruptive by a teacher or by peers, or
have been required to repeat a grade in school--all signs that
the risk of future violence has been sharply reduced.
--The Prenatal and Early Infancy Project randomly assigned half of a
group of at-risk mothers to receive visits by specially trained
nurses who provide coaching in parenting skills and other
advice and support. Rigorous studies show the program not only
reduced child abuse by 80 percent in the first two years, but
that fifteen years after the services ended, these mothers had
only one-third as many arrests, and their children were only
half as likely to be delinquent.
Many of our members are conservatives who believe we should, in the
long run, be able to cut taxes. Our experience and hard scientific
evidence prove, however, that boosting investments in children now will
save lives and tax dollars, leaving far more money for tax cuts, paying
down the debt, and preserving social security down the road. For
example:
--Economist Steven Barnett found that the High/Scope Foundation's
Perry Preschool study saved $150,000 per participant in crime
costs alone. Even after subtracting the interest that could
have been earned by investing the program's funding in
financial markets, the project produced a net savings of
$7.16--including more than six dollars in crime savings--for
every dollar invested.
--A study by Professor Mark A. Cohen of Vanderbilt University
estimated that for each high-risk youth prevented from adopting
a life of crime, the country would save between $1.7 million
and $2.3 million.
--A Rand Corporation report showed that, even without counting the
savings to crime victims and society, the resulting savings to
government alone from effective early childhood programs
exceeded by two to four times the cost of the programs.
Yet these dollars savings do not measure the greatest savings of
all.
One child was killed in Mount Morris, 12 in Littleton. In an
average week, 40 children are killed in America by violence. About 98
percent of these killings take place outside of school. That's over 150
Littletons a year if we do nothing.
The Fight Crime: Invest in Kids School and Youth Violence
Prevention Plan will not prevent every incident of violence, but it can
save thousands of lives--whether from school shootings or the out-of
school tragedies that take an even more massive toll on our children--
in the years ahead, all the programs for which we are calling for
funding increases are consistent with our School and Youth Violence
Prevention Plan.
The programs for which we are calling for increased investments are
consistent with the recommendations made by the Bi-Partisan Working
Group on Youth Violence. Speaker Hastert and Minority Leader Gephardt
created the working group to examine the evidence on measures to curb
youth violence and to recommend a plan of action for Congress to take.
Not surprisingly, the working group's conclusions to cut you violence
echo the recommendations of law enforcement and crime survivor leaders:
--``Effective federal programs must be fully funded to achieve the
largest impact on early childhood development and, ultimately
youth violence. Studies have estimated that for every dollar
invested in quality early education, about seven dollars are
saved in later costs.''
--``Congress should increase funding for high quality effective early
childhood programs, evaluate all federally-subsidized early
childhood programs, and identify areas for improvement and
where new areas could be implemented.''
--``The subgroup recommends that Congress provide increased support
for a range of prevention and early intervention strategies
targeted toward at-risk youth and their families, including
school-based and after-school programs.''
--``Congress needs to take steps to ensure that every child has
access to high quality after-school activity. . . . We agree
with the nation's police chiefs that after-school programs for
youngsters are a more effective way to fight crime.''
--``We need to make sure that child protective services staff have
sufficient resources to identify and treat abused and neglected
children. We must also act before children are hurt by
expanding programs proven to reduce cases of abuse and
neglect.''
Speaker Hastert promised that the working group's recommendations
``which are legislative in nature would follow the normal committee
process but be addressed promptly.'' Now it is time to act.(A copy of
the report can be found on Jennifer Dunn's website http://
www.house.gov/dunn/workinggroup/wkg.htm.)
We hope that you choose to put Congress this year on a path to full
implementation of our School and Youth Violence Prevention Plan and of
the recommendations of the Bi-Partisan Working Group on Youth Violence.
Following this path will produce massive cuts in crime and violence.
Thank you for your consideration.
______
Prepared Statement of the National Military Family Association
NMFA and the families we represent are grateful to this
Subcommittee and to the United States Senate for its actions on behalf
of military children and the Impact Aid Program. We thank all the
Congressional supporters of Impact Aid, especially the members of the
House and Senate Impact Aid Coalitions, for securing another increased
appropriation for the program for fiscal year 2000. Your continued
support of this program translates into better education for
approximately 550,000 military children and several million of their
civilian classmates in school districts across the country.
the military child
NMFA presents this statement on behalf of military families, or
more specifically on behalf of military children:
--Military children move every 2 to 4 years and attend an average of
six different schools. Less than 20 percent of these children
attend Department of Defense Schools; the overwhelming majority
of military children attend civilian schools dependent on
Impact Aid.
--Military children bring a wealth of cultural experiences gained
from living in many parts of the world to their new schools.
They also frequently come with gaps in their education that
their new teachers must quickly fill while moving the rest of
the class ahead. Sometimes they are far ahead of their new
classmates, adding boredom to the list of reasons why they hate
moving to yet another new school.
--Because of varying course standards, school schedules, and state
graduation requirements, they sometimes lose credits needed for
graduation or they must take state accountability tests on
subject matter they never learned. A change of schools at any
time is traumatic, but a change in the middle of the school
year is especially so. A mid-year transfer can place some
children so far behind, they cannot catch up the rest of the
school year, especially if a district does not have the
resources for a good transition program.
--Because of the high operations tempo of today's military, the
military child often has to adjust to the new school, face that
week of standardized tests, fight for the spot on the newspaper
staff, play the basketball game before a crowd of strangers all
without the support of their military parent. Worry about the
safety of a parent in a place far from home where people are
shooting at each other makes for a powerful distraction from
the business of education.
Military families want to be involved in their children's education
and list education as one of their top quality of life issues. While a
concern about the quality of their children's education is rarely the
sole reason military members leave the service, the stress caused to a
child by one-too-many moves, the special services not received when
needed, or the prospect of an assignment at an installation where the
schools have a poor reputation may be enough to convince a service
member that it is time to leave the military.
why impact aid? the federal responsibility
Military families understand that the Impact Aid program supports
basic education services provided by their local school districts. They
understand the impact the federal presence has on the tax base of these
local districts and their states. They understand the impact their
children and the transient military lifestyle can have on their local
schools.
--Children living on Fort Belvoir, Virginia attend the Fort Belvoir
Elementary School, operated by Fairfax County. In school year
1998-1999, the school's highest enrollment was 1,320 students.
During the year, the school experienced a turnover rate of over
50 percent. Not counting the summer rotations, 706 students
came in and out of the school. Think of the records that must
be prepared, the evaluations and testing for special programs
that must occur, the children unable to concentrate because
another best friend has moved away, the anxiety faced when the
newcomers don't know anyone who will eat lunch with them!
--The average soldier at Fort Hood, Texas deployed 120-160 days in
fiscal year 1999. The average airman at Offutt Air Force Base,
Nebraska deployed over 120 days. Think of the Parent-Teacher
conferences missed, the volunteers unavailable to support
school activities, the families stretched too thin. Research
shows that involved parents promote academic achievement.
Deployment makes that involvement more difficult both for the
deployed servicemember and the spouse trying to keep things
together at home.
Military families hold the government, and the citizens they have
sworn to serve and protect, accountable for living up to their promise
to provide a quality education for their children. The districts have
accepted the responsibility to educate military children; the Federal
Government must provide the resources it has promised to support that
education.
--The intent of the original Impact Aid legislation (Public Law 81-
874) was ``to provide financial assistance for those local
educational agencies upon which the United States has placed
financial burden.'' It originally provided an ``in-lieu-of-
tax'' payment equal to the local per-pupil costs for students
whose military parent both lived and worked on a federal
installation (these students were designated A students) and
one-half of the local per-pupil cost for students whose
military parent worked on a federal installation but lived in
the civilian community (B students).
--It costs an average of over $6,000 to educate a child in the United
States today. But the current average Impact Aid payment for an
A child is approximately $2,000; the average payment for a B
child (now set at only .10 of the amount for the military A
students) is $200, nowhere near the original intent or actual
cost of educating a child.
Once again, NMFA thanks this Subcommittee for its continued funding
of Impact Aid for the military children who live off the installation,
the ``military Bs.'' Although military families living in the civilian
community pay property taxes to help support local schools, they often
do not contribute to other sources of education funding. States provide
an increasingly larger share of local districts' funding. Many military
members pay no state tax on their military income. They also shop in
military exchanges and commissaries, thus paying no sales tax. Under
the provisions of the Soldiers' and Sailors' Relief Act, they are often
exempt from paying personal property taxes or license fees for
automobiles if they are on military orders away from their home state.
--The local tax base for the Bellevue, Nebraska school district that
educates the children living on or near Offutt Air Force Base
generates only $12 million of the district's $54 million annual
budget. Each year the county loses $5 million in license plate
fees because military members stationed at Offutt may license
their vehicles in their home states rather than Nebraska.
--The Copperas Cove Independent School District serves children whose
parents are assigned to Fort Hood, Texas. All but about 100 of
the district's 2,700 military children live in the civilian
community adjacent to Fort Hood and approximately 30 percent of
the district's budget comes from Impact Aid. If funding for
military B students was discontinued, district officials
estimate they would have to raise property taxes 51.3 cents per
$100 of valuation.
--As the military services look to the civilian community to provide
more housing for military families, the number of B students
will increase, thus raising the burden on districts charged
with educating them.
fix the schoolhouse
For a newly-arrived family in a military community, the sight of a
well-maintained, safe, child-friendly school building can calm many
anxieties about their latest move. Unfortunately, too many military
children must deal with those anxieties in a school facility that has
seen better days.
--Although Impact Aid provides much of a heavily-impacted district's
working capital, it cannot be stretched to fund the facility
maintenance and improvements old school buildings need.
Military families at many installations voice concerns about
the repairs needed for these buildings and the lack of
available funds. At Grand Forks Air Force Base, for example,
parents with children at the combined elementary/middle school
note the work needed. The district only recently allocated
funds to meet accessibility laws. The building has no
handicapped-accessible bathroom, entrance or exit ramps, or
lift or elevator to the second floor. Designed as an elementary
school, the building has no adequate gym space for middle
school programs and needs a new boiler. It has windows that are
boarded up and frosted over or, as described by one military
spouse, ``windows that have been re-caulked so many times there
is more caulk than window sill.''
--NMFA remains concerned about the upgrade and maintenance needs of
school buildings owned by the Department of Education. The
Waynesville R-VI School District, for example, operates seven
buildings owned by the Department of Education on Fort Leonard
Wood, Missouri. Although one school has been recently
renovated, the district estimates that it needs approximately
one million dollars per school to bring the rest up to
standard. The district used its own funds to wire the
Department of Education buildings for the Internet so that the
military children attending these schools would not fall behind
their peers in district-owned buildings. In addition to facing
pressing maintenance and renovation needs, the district is also
coping with the addition of 600 Army children it received from
units moved to Fort Leonard Wood following the closure of Fort
McClellan, Alabama. To a district with only 5,100 students in
old school buildings, an additional 600 children becomes a
strain on the system.
one child, many schools
The education of a military child is a continuum. As the military
child moves from school district to district--from a school receiving
Impact Aid in Texas, to another Impact Aid school in Virginia, to a
Department of Defense school in Germany to another Impact Aid school in
Illinois--the quality of education she receives in each school will
affect the education she and her classmates receive in the next.
Children whose schools are unable to provide the necessary educational
services could easily fall behind their peers in other districts.
Schools serving these children could face difficulties in maintaining
accreditation as tough new standards are implemented in many states. A
smooth transition into their next school, whether across the state or
across the country, benefits military children, their classmates, and
their communities.
The Impact Aid program enables districts affected by the presence
of a military installation to offer not only a quality basic education
program, but also the support services needed by military children as
they transition from school to school.
--Over 50 percent of the 3,783 students in the Indian River Central
School District in New York are military children whose parents
are stationed at Fort Drum. Because of Impact Aid, the district
can afford the Reading Recovery program to help first graders
master important reading skills to reach grade level. At the
high school level, the district is developing a remediation
system to help newly-transferred students prepare for the New
York Regents exams, which will soon be required for graduation.
Impact Aid funds help buy stringed instruments for the
district's orchestra program. They provide for the support
system--the counselors, psychologists, and social workers--
often needed by children when their military parent deploys.
The 10th Mountain Division recently returned to Fort Drum after
its deployment to Bosnia. While the school administration was
initially concerned about a flight from the community during
the deployment, it found that most military families chose to
remain in the area. The strong assistance system at Fort Drum
and the community support as evidenced in the school programs
funded through Impact Aid persuaded families to stay.
--School districts serving military children recognize their
interdependence and their shared responsibility for the
education of those children. They are increasing their
communication with each other to ease the transition of
military children in and out of different school systems.
--Recognizing that service members view quality education as an
important quality of life factor and a retention issue, the
military services have stepped up their efforts to establish
partnership programs with local schools, to train installation
school liaison officers, to provide better information to
families about local schools, and to study the problems faced
by military children as they move. They are working across the
services on common issues and are reaching out to military-
related and education organizations, such as NMFA, the National
Association of Partners in Education, and the Military Child
Education Coalition.
Military parents view the partnerships between their schools and
the military services--from the unit adopting the local elementary
school to the presence of service and DOD leadership at annual
educational conferences on ``Serving the Military Child''--as progress
toward relieving some of the anxieties about their children's
education. The educational focus of these efforts is a legacy of a
successful, well-funded Impact Aid program. When the Federal Government
fulfills its responsibility to provide funding for basic education to
districts serving military children, the schools can concentrate on
providing a high-quality education program for all students. We thank
you, the Members of this Subcommittee, for your leadership in this
partnership for the education of military children. We ask you to
continue this role by fully funding Impact Aid.
______
Prepared Statement of the National Indian Impacted Schools Association
The National Indian Impacted Schools Association represents public
school districts which contain Indian trust land and Alaska Native
lands. The Impact Aid program provides federal funds for public school
operations that would have otherwise been provided by local tax
revenues but for the presence of federal property--in our case,
primarily lands held in trust by the federal government for Indian
tribes.
Approximately 90 percent of Indian and Alaska Native elementary and
secondary students nationwide attend public schools. Most of the
remaining 10 percent of students attend Bureau of Indian Affairs-system
schools whose operating budgets come through BIA appropriations.
Summary of Request.--We ask the Subcommittee to recommend the
following with regard to the fiscal year 2001 Department of Education
budget:
--Impact Aid Basic Support Payments.--$818 million for Impact Aid
Basic Support payments under Section 8003(b) of the Impact Aid
statute. This is the same as the request of the National
Association of Federally Impacted Schools (NAFIS) and is 10.9
percent over the fiscal year 2000 enacted level.
--Impact Aid Facility Repair.--$25 million under the authority of
Section 8007 of the Impact Aid statute for payments for
facility repair, renovation and construction. This is the same
as the request of NAFIS and compares to the fiscal year 2000
enacted level of $10.1 million and the Administration's request
of $5 million. While this is termed a ``construction'' account
in the authorizing statute, the funds are distributed by
formula to schools, making the amount individual school
districts receive so miniscule that it cannot make a
significant impact on facility construction needs. In fiscal
year 2000, $3 million was earmarked by Congress for three
specific schools.
--Forward Funding of Impact Aid.--Impact Aid is one of the few major
federal education programs which are not forward funded. Even
if we were not experiencing delays in distribution of Impact
Aid funds as we are now, it would be enormously helpful for
planning and budgeting purposes for the program to be forward
funded.
The Impact Aid Program in Indian Country.--For Indian country, the
Impact Aid program is a vital element of the public policy of providing
every child a free public education. Signed into law in 1950, the
Impact Aid program is one of the oldest federal education programs.
Simply put, it provides federal funds for public school operations that
would have otherwise been provided by local tax revenues but for the
presence of federal property--in our case, lands held in trust by the
federal government for Indian tribes. One of the great attributes about
the Impact Aid program is that it provides flexible funds to school
districts. Because Impact Aid funds are actually in lieu of a property
tax base, it is logical that they are not geared toward specific
program use.
The Impact Aid program is an example of the U.S. government
carrying out its trust responsibility--in this case, for education--for
Indian and Alaska Native peoples. Some facts about the Impact Aid
program in Indian Country:
--There are over 600 school districts throughout the country which
receive Impact Aid funds for Indian lands schools.
--Funds for Indian lands students represent nearly 50 percent of the
federal Impact Aid appropriation.
--The Indian Country land base that generates Impact Aid funds
consists of 53 million acres of Indian trust land in the lower
48 states and 44 million acres included in the Alaska Native
Claims Settlement Act.
--The Impact Aid program provides a formal link between tribal
governments and public schools, providing for school district
consultation with Indian tribes and tribal communities. This is
especially important because public schools are State
institutions, but located within tribal boundaries. School
districts must consult with tribes and the Indian community to
develop Indian Policies and Procedures (IPP). Tribes and
parents of Indian students are able to comment on whether
Indian students are equal participants in educational programs
and school activities, and to request modifications in school
programs and materials. Tribes also have administrative appeal
rights under the statute.
The Level of Impact Aid Effects Student Performance--the Santee
School Experience.--We would like to give you an example of how
increased Impact Aid funds resulted in dramatic academic improvement
for the students of the Santee School District.
On March 17, 1999 the House Education and the Workforce
Subcommittee on Early Childhood, Youth and Families held a hearing on
reauthorization of the Impact Aid program at which Chuck Squier,
Superintendent of the Santee School, testified. The Santee School
District in northeast Nebraska is made up of entirely Indian trust
lands and its students are Santee Sioux. Superintendent Squier
testified about the impressive student gains which have been made since
his school district has received an increase in Impact Aid funds.
Prior to 1995 the school district had been receiving only 60 to 70
percent of the amount of Impact Aid for which it was eligible. Reading
scores had dropped during the previous three years: 1st grade scores
dropped from 1.8 to 1.2 GME; \1\ 8th grade scores dropped from 7.4 to
5.9 GME, and 11th grade scores dropped from 10.2 to 9.4 GME. In an
effort to reverse this trend, the school district formed a Curriculum
Committee composed of school staff, parents and other community
members. They reviewed current research on ways to improve student
reading and decided on a plan of action which included teacher
training, a reading management system, multiple copies of books, a
daily focus on reading and ninth hour tutoring. Specific programs
included reading recovery, accelerated reader, school at the center,
foss science, and project read. However, the recommendations of the
Curriculum Committee were not able to be implemented because of lack of
money.
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\1\ GME stands for Grade Means Equivalency.
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But when the Impact Aid program was re-authorized in 1994, Impact
Aid funding increased for the Santee Sioux school. The school district
was able to use that money to leverage additional grant dollars for
teacher training and research-based reading programs and the rest of
the plan recommended by the Curriculum Committee. The plan was
implemented. Students are tested in the fall and in the spring, and the
results have been very impressive. Last year, 28 percent of the
students in grades 3-12 increased their reading level two grade levels.
Another 25 percent of students raised their reading level 1.5 or more
grade levels, and 36 percent of students raised their reading level 1
or more grade levels. Particularly gratifying was the 9th grade
results, as this class had declining scores for the previous three
years. Expansions of the school-wide reading program are planned for
next year, along with rewriting the math/science studies/language arts
curriculum--financial resources permitting.
The Santee School District program is shared through the Nebraska
Native American consortium, which serves 98 percent of all students in
Nebraska living on tribal lands.
The Impact Aid Program Should Be Forward Funded.--We urge Congress
to take the long overdue step of providing appropriations to forward
fund the Impact Aid program. Other major education programs, e.g.,
Title I, Individuals with Disabilities Education Act, and Bureau of
Indian Affairs school operations, are forward funded. Public school
administrators in heavily impacted districts must make very difficult
and risky program and personnel decisions for the upcoming school year
or the next school year without knowing how much Impact Aid funding
they will be receiving. For many Indian lands schools, Impact Aid is
the primary source of school operations funding and the schools would
close without it.
While school administrators cope with this system, it makes much
more sense for a school administrator to know 6-12 months prior to the
beginning of the school year what its budget will be. For example, in
Minnesota we are required to sign contracts for tenured teachers by
April 15th for the upcoming school year. For non-tenured teachers, we
must sign contracts by June 1 for the Fall term. Because Impact Aid is
not forward funded, we must sign contracts for tenured teachers 4\1/2\
months prior to the knowing the amount of money we will receive--and
that is under circumstances when we have a Labor-HHS-Education
Appropriations bill which is signed by October 1st--a rare occurrence,
as you know.
When the government shut down several years ago, Impact Aid schools
had to borrow money just to stay open and had to pay large amounts of
interest--tens of thousands of dollars for some schools--for which they
were not reimbursed. Some Impact Aid schools are in the position now of
having to borrow money because of problems at the Department of
Education resulting in chronically late Impact Aid payments. We know
that Congress understands this problem because it has made most federal
education programs forward funded. Impact Aid is a program of basic
support for schools--it hires the teachers, pays the utility bills,
transports students, etc. and this makes it all the more urgent for it
to be forward funded.
We realize that the first year of forward funding will strain the
appropriations process as Congress would have to make available two
years worth of funding. On the other hand, we have a budget surplus and
there is support from the Administration and both parties in Congress
for increased federal education funding.
If the Impact Aid program cannot be forward funded in total, we
suggest that the Basic Support and the Disabilities portions of the
program could be forward funded or Congress could look at the
possibility of a phased-in approach to forward funding.
School Facilities.--School facilities construction and renovation,
including making facilities ready for education technology, is a high
priority for our organization. We urge you to appropriate at least $25
million for school facility repair as authorized under Section 8007 of
the Impact Aid law. Ultimately however, we need more than a band aid
approach to school construction needs.
NIISA has and will continue to work with Congress on pending school
construction proposals to make them responsive to the needs of our
schools--Indian lands public schools. School construction bills have
been introduced in a steady stream during the last two Congresses and
also the current Congress. We have seen in these bills a growing
recognition that there needs to be accommodation for public school
districts which have little, if any, bonding capacity (including those
schools in the Bureau of Indian Affairs system). For instance, there
are now bills which would allow a state to issue school construction
bonds (not just the LEA) and which would require the state application
to explain how they will assist schools that lack the fiscal capacity
to issue bonds on their own. This could be helpful to some school
districts with Indian lands. To the extent that a school district has
limited ability to generate revenues because of a federal presence
(e.g., the existence of Indian trust land or federal property in the
school district), there is a clear federal responsibility toward the
education of the children attending those schools.
The condition of public and Bureau of Indian Affairs school
facilities has been documented in General Accounting Office (GAO)
surveys. Because the GAO surveys did not report data specific to Indian
lands public schools, our organization, in October, 1996, undertook a
survey of school districts which receive Indian lands Impact Aid
funding. Some of the findings from the survey, which we have previously
reported to this Subcommittee, are:
--65 percent of buildings are over 20 years old, including 38.2
percent over 30 years old;
--$6,872,000 is the average estimated costs necessary for repairs,
renovations, modernization and construction to put schools in
overall good condition;
--the average cost per student to make school buildings meet health
and safety standards is $1,947;
--to accommodate expected increased enrollment over the next 5 years,
the schools responding to the survey will need 13.1 percent
more space. Within 10 years, the space needs are expected to
increase by 27.9 percent;
--71 percent of school districts have had no school construction bond
issued since 1985, and 23 percent of school districts have
never had a bond issued;
--Of schools with 70 percent LOT MOD and higher, the need for
construction, renovation, and repair funding is two thirds
higher per pupil than in the other respondents to the NIISA
survey. (Note: LOT MOD is a Department of Education measure of
need of school districts affected by the presence of federal
property);
--42 percent of respondents have unhoused students;
--59 percent of school buildings have inadequate laboratory science
space;
--63 percent of schools are not well served for before/after school
care.
Thank you for your interest in the need of our public schools which
educate children from Indian country. We ask you to always keep in mind
the trust responsibility for the education of Indian and Alaska Native
children and the federal responsibility regarding school districts
which contain Indian and federal property.
______
Prepared Statement of the United Stribes Technical College
Summary of Request.--For thirty years United Tribes Technical
College \1\ (UTTC) has been providing postsecondary vocational
education, job training and family services to Indian students from the
Great Plains and throughout the nation. UTTC was assisting Indian
people in moving from public assistance to economic self-sufficiency
long before the 1996 welfare reform act. We have a sustained placement
rate of well over 80 percent. Our request for fiscal year 2001 funding
for tribally controlled postsecondary vocational institutions as
authorized under Carl Perkins Vocational and Applied Technology Act is:
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\1\ The college is owned and operated by five federally-recognized
tribes situated wholly or in part in North Dakota--Spirit Lake Sioux
Tribe, Sisseton-Wahpeton Sioux Tribe, Standing Rock Sioux Tribe, three
Affiliated Tribes of the Fort Berthold Reservation, and Turtle Mountain
Band of Chippewa. Control of the institution is vested in a ten-member
board of directors comprised of elected Tribal Chairpersons and Tribal
council members.
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--$5 million, or $400,000 over the fiscal year 2000 enacted level and
the Administration's request. This funding is essential to our
survival as we receive no state-appropriated vocational
education monies.
--Committee Report language asking for the report required of the
Department by the Vocational and Applied Technology Education
Act regarding training, facilities and housing needs of the
tribally controlled postsecondary vocational institutions. (20
USCA Sec. 2327(g) (2) and (3). This report should be undertaken
in close collaboration with the affected institutions. Attached
is the statutory provision.
Funding Authority.--Section 117 of the Carl Perkins Vocational
Education and Applied Technology Education Act Amendments of 1998
authorizes funding for tribally controlled postsecondary vocational
technical institutions. Under this authority funding is currently
provided to UTTC and one other tribally controlled postsecondary
vocational institution, the Crownpoint Institute of Technology. The
Administration's fiscal year 2001 request is $4.6 million, the same as
the fiscal year 2000 enacted level. There is a glitch in the Perkins
Act in that it caps funding for Tribally Controlled Postsecondary
Vocational Institutions at $4 million instead of ``such sums as may be
necessary'' in the out years as is the case for other vocational
education programs. This was inadvertent and we ask for a technical
correction to provide for ``such sums as may be necessary'' for fiscal
year 2000 and the out years.
A Unique Inter-Tribal Educational Organization.--United Tribes
Technical College is the only inter-tribally controlled, campus-based,
postsecondary vocational institution for Indian people. Our campus is
the site of the Fort Lincoln Amy Post, an 110-acre area near Bismarck,
North Dakota. We currently enroll 367 students from 32 tribes and 14
states. And we serve 159 children in our pre-school programs and 148
children in our elementary school, for a direct services population of
654.
Educating Students and Placing Them in Jobs.--We are proud of the
education, skills and services provided by UTTC for our students and
their families. And we are proud that this education is taking place in
a setting they where can maintain and strengthen their tribal heritage.
We have had a sustained job placement rate exceeding 80 percent over
the last 10 years. This success is all the more gratifying in light of
the background of our students, most of whom come from tribal areas
where poverty and unemployment are the norm. Many of our students are
from the 14 tribes in the Dakotas, where unemployment among Indian
people is chronic. BIA Labor Force data reports the percentage of
potential Indian labor force on and near reservations in the Aberdeen
Area who are jobless is 71 percent. Of those persons who are employed
33 percent are still living below the poverty guidelines. (Source:
Interior Department 1997 Labor Market Information On the Indian Labor
Force.)
UTTC New Course Offerings.--We offer 9 Certificate and 15 Associate
of Applied Science degree programs (see attached list). We are very
excited about the recent additions to our course offerings, and the
particular relevance they hold for Indian communities. The modest
increases in our Department of Education funding has helped make these
new programs possible. These new programs are:
--Injury Prevention
--Dietetics Technician
--Tribal management, including gaming management
--Computer Science Technology
--Distance Learning programs for the Denver Indian Community
Dietetics/Diabetes.--Through collaborative efforts with the
American Diabetes Association, UTTC will develop the only accredited
Dietetics Technician's Degree program in the state. We will meet the
challenge of fighting diabetes through education. As this Subcommittee
knows, the rate of diabetes is very high in Indian county, and with
some tribal areas experiencing the highest incidence of diabetes in the
word. About half of Indian adults have diabetes (``Diabetes in American
Indians and Alaska Natives, NIH Publication 99-4567, October, 1999).
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 (Source: IHS fiscal year 1999 Budget
Justification). We received assistance through the IHS to establish the
only degree-granting Injury Prevention program in the nation.
Distance Learning.--We are bridging the ``digital divide'' by
providing critical computer and Internet skills from our North Dakota
campus to American Indians residing in the Denver area. Technology
training allows all American Indians an opportunity to overcome
barriers such as geographic isolation and access to information.
Through technology partnership programs, UTTC is meeting the challenge
of providing technology skills and training to Indian country.
UTTC has been, in addition, a member since 1994 of the Interactive
Video Network of North Dakota's colleges, universities and tribal
colleges. This allows for articulation agreements with other college
and universities, expanding the educational opportunities for our
students.
Job Training and Economic Development.--UTTC is a designated Indian
Minority Business Center serving Montana and the Dakotas. We also
administer a Workforce Investment Act program and an internship program
with private employers. And we are assisting tribes and tribal members
in the Aberdeen Area with rebuilding buffalo herds.
Coordination with State Welfare-to-Work Efforts.--UTTC is working
in cooperation with the state of North Dakota on welfare reform. We are
serving state-referred Temporary Assistance for Need Families (TANF)
recipients who are able to participate in our Cooperative Education
internship program with private employers. By attending UTTC, these
TANF recipients can meet their work, training and volunteer
requirements. And we are providing child care for 20 children of state-
referred TANF recipients.
In North Dakota, only 30 percent of state TANF recipients are
allowed schooling as a work activity. And we also take exception to the
12-month statutory limit on the length of time a TANF recipient can be
enrolled in a vocational education course and still be eligible for
TANF. This limits TANF recipients to taking one-year certificate
courses at UTTC. Our experience shows that the students who graduate
from a two-year, rather than a one-year, course have significantly
higher earning power. Many of our students come to UTTC planning to
take a one-year course, and then, finding themselves in a supportive
environment and seeing the economic benefit of the longer course,
decide to work for the two-year degree.
Serving Families Contributes to Education and Job Placement.--We
believe that a primary reason for UTTC student success is that we serve
the students' social, academic and cultural needs. Many of our students
are the first generation in their family to attend college, and for
many it is their first experience in living away from home. Many
students are on public assistance and many have families of their own.
Some of our services are:
--Early childhood services for 145 children, ages birth to five years
and an additional 15 elementary children for extended care;
--Theodore Jamerson Elementary School serving 148 Indian students;
--A health clinic whose services includes immunization, health
education, eye and dental exams, and referrals to other health
care providers;
--Family housing and dormitories for solo parents and for students
without children;
--A local transportation system for students for school activities
and necessary appointment e.g., (doctor appointments) outside
the campus. Most UTTC students do not have cars.
UTTC Seeks Non-Perkins Funds.--UTTC is aggressive in seeking non-
Perkins funding for special needs, e.g., we combined Department of
Agriculture, Economic Development Administration and state Community
Development Block Grant funds and replaced our aging water, sewer and
gas systems in 1997.
Our elementary school received a Department of Education grant for
computer technology, and was one five BIA-system schools to receive
this funding. We also received a Kellogg Foundation grant to develop
buffalo management skills for the tribes and their members throughout
the Aberdeen Area, as they attempt to rebuild herds of buffalo
decimated more than 100 years ago. And this year we received a $75,000
grant from U.S. West to assist us in developing a series of distance
learning classes at the Indian Center in Denver. Additionally, our
Injury Prevention Program has been assisted through a grant from the
IHS.
The above mentioned grants are highly competitive, restrictive,
one-time grants, and they cannot provide for day-to-day operations. We
cannot survive without the basic operating funds which come through the
Perkins Act.
Facility Study/Current Needs.--We are dismayed that the Department
of Education has paid no attention to the requirement in the 1998
Perkins Act Amendments to undertake a study of our housing, facility,
and training needs. Discussions with the Department shows that it is
not even on its radar screen. Such a study would certainly be of
benefit to us in planning and in seeking funds. Below are some of our
financial needs of which we want you to be aware:
--Housing.--We need new and rehabilitated campus housing so that we
can increase student enrollment. Many of our buildings are of
historic importance. The College occupies the old Fort Lincoln
Army Post, and many people visit our campus to see these
buildings. Other than the more recently constructed skills
center and the community center, UTTC's core facilities are 90
years old. Estimates for new facilities total over $12 million,
according to a 1993 Dept. of Education report.
--Salaries.--We were able to provide a cost-of-living increase for
our employees last year. However, our faculty still receive
salaries that are lower than in any state college system.
--Emergency Repair.--We need funding for emergency repair on student
housing and instructional facilities. Funding is also needed
for maintenance and repair related to damaged caused by
inclement weather, including blizzards, high winds and
extremely low temperatures.
--Course Offerings/Student Services.--We want to change some of our
courses to better meet new market demands, e.g, training to
increase the number of students in the allied health
professions, updating of technology. We also need to expand our
diagnostic capabilities in tribal-specific areas and in the
areas of literacy and math-science background. And we want to
make improvements in our student follow up, career development,
and job market research efforts.
Thank you for your consideration of our request.
______
RELATED AGENCIES/GENERAL TESTIMONY
Prepared Statement of the National Federation of Community Broadcasters
Thank you for providing me 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 150 community
radio stations across the country. 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. Nearly half of our members are rural stations and
half are minority controlled stations.
In summary, the points we wish to make to this Subcommittee are
that NFCB:
--Supports the CPB request of $365 million for fiscal year 2003;
--Requests the Subcommittee 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 $365 million for the Corporation for
Public Broadcasting in fiscal year 2003.--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 ability of the community to financially support the
station is insufficient 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.
In the last year, CPB has increased supported to rural stations and
committed resources to helping public radio take advantage of new
technologies. We commend these activities 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 would like to commend 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 the same way, American Indian Radio on Satellite (AIROS) is
distributing programming for the Native American stations, arguably the
fastest growing groups of stations. There are now over 30 stations
controlled by and serving Native Americans, primarily on Indian
reservations.
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.
Finally, community radio supports funding for conversion to digital
broadcasting by public radio and television.--While public television's
needs are more immediate, the Federal Communications Commission is now
in the process of identifying a standard for digital radio
transmission. We expect that there will be funds available for radio
conversion as well as television conversion. More immediately, the
television conversion process is already having an impact on public
radio stations. As television stations increase the space they need on
their towers to accommodate both analog and digital signals, radio
stations that rent space on TV towers are losing their leases and being
forced to move to other towers--sometimes with very short notice. This
situation will only get worse over the next three years as we approach
the FCC deadline for television conversion. We would like to see
emergency funding to help public radio stations who lose their tower
space do the necessary engineering studies and move to new tower
locations.
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 2001 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 and particularly community radio, more unique and more
important as a local voice than we have ever been. During this time,
the role of CPB as a convener of the system becomes even more
important. And the funding that it provides will allow the smaller
stations to participate along with the larger stations who have more
resources, as we move into a new ear of communications.
Thank you for your consideration of our testimony.
______
Prepared Statement of the National Association of Foster Grandparent
Program
We are pleased to submit this testimony in support of fiscal year
2001 funding for the Foster Grandparent Program (FGP), the oldest and
most well-known of the three programs known collectively as the
National Senior Volunteer Corps, which are authorized by Title II of
the Domestic Volunteer Service Act of 1973, as amended (DVSA) and
administered by the Corporation for National and Community Service
(CNS).
NAFGPD is a membership-supported professional organization whose
roster includes the majority of more than 350 directors who administer
Foster Grandparent Programs nationwide, as well as local sponsoring
agencies who support the work of FGP.
thank you
Senator Specter, before we begin our testimony, we must first thank
you for the courage and leadership you showed during the fiscal year
2000 appropriations process in preserving the original mission and
purpose of the Foster Grandparent Program: to enable seniors living on
incomes less than 125 percent of the national poverty level to serve as
Foster Grandparents and contribute to their communities. Your clear
direction to the Corporation for National and Community Service--that
funds appropriated by Congress may not be used to pay a non-taxable,
non-income payment to individuals whose incomes exceed 125 percent of
the national poverty level--has preserved our program for those low-
income seniors for whom it was originally intended. Again, thank you
for your leadership.
fgp: an overview
Established in 1965, the Foster Grandparent Program was the first
federally funded, organized program to engage older volunteers in
significant service to others. From the 20 original programs based
totally in institutions for children with severe mental and physical
disabilities, FGP now comprises nearly 350 programs in every state, the
District of Columbia, Puerto Rico, and the Virgin Islands. All programs
are now primarily based in community volunteer sites--where most
special needs children can be found today--and are administered locally
through a non-profit organization or agency and an Advisory Council
comprised of community citizens dedicated to FGP and its mission. FGP
represents the best in the federal partnership with local communities,
with federal dollars flowing directly to local sponsoring agencies,
which in turn determine how the funds are used. There are currently
28,500 Foster Grandparent volunteers who give over 24 million hours
annually to more than 180,000 children.
The Foster Grandparent Program is unique. We are one of only two
volunteer programs in existence that enable seniors living on very
limited incomes to serve their communities as volunteers by providing a
small non-taxable stipend and other support which allow volunteers to
serve at little or no cost to themselves. Our volunteers provide
intensive, consistent service--20 hours every week, usually four hours
every day. FGP provides extensive pre-service orientation and at least
48 hours of on-going training annually to keep volunteers informed on
how to work with children who have special needs. And our volunteers
provide one-to-one service to their assigned children, exactly what is
required to help prepare our nation's neediest children to become self-
sufficient adults.
The rapidly growing number of older people living at poverty-level
incomes across the country represent a virtually untapped resource that
must be utilized to help address the serious problems of today's
children. In order to continue to provide these cost-effective services
in even more local communities the Foster Grandparent Program requires
more volunteers, and more locally-based programs. We need funding
levels that will enable us to keep pace with the ever-increasing number
of income eligible seniors--currently 6,000,000, a number which will
grow to 13,200,000 by the year 2030--and the countless number of at
risk children who will need the one-to-one attention of an older person
with the time to help show them the way to independence and productive
adulthood.
the administration's fiscal year 2001 request for fgp
Unfortunately, in a budget which requests increases in excess of 23
percent ($100 million) for AmeriCorps and related programs, the
Administration has, for the second year in a row, proposed an increase
of $1.79 million (1.87 percent) for the Foster Grandparent Program--
again, for the second year in a row, the smallest increase requested
for any of the programs administered by CNS. Rather than investing
federal funds in increasing the number of FGP volunteers serving
nationwide, the Administration's request appears to set as a priority a
67 percent increase for senior demonstration targeted mainly to make
grants to national organizations which have nothing to do with FGP or
the other two senior volunteer programs. The largest, oldest and most
well-known of the three senior volunteer programs--the Foster
Grandparent Program--is virtually ignored in this budget, as it was in
the Administration's fiscal year 2000 budget.
In addition, by way of a never-before-used interpretation of
Section 225 of the Domestic Volunteer Service Act of 1993 (Programs of
National Significance, or PNS, grants), which was enacted in 1989, the
Administration fails to designate at least one-third of the fiscal year
2001 increase requested for FGP for PNS expansion grants for existing
programs. The intent of Sec. 225 when enacted was to ensure that at
least one-third of any increases would be made available to current
FGP, SCP, and RSVP projects to expand the number of volunteers in their
communities. In fact, since 1989 the one-third PNS set-aside has been
the ONLY mechanism by which current programs have been able to expand
their volunteer numbers and meet their communities' needs. CNS even
held fast to the one-third PNS set-aside in fiscal year 1997, when the
increases received by the three programs represented only a restoration
to fiscal year 1995 levels after the programs experienced
appropriations cuts in fiscal year 1996. This new interpretation is
whimsical and unacceptable, and will establish a dangerous precedent
for the use of future appropriations if allowed to stand.
The Administration's budget also fails to request funds to increase
the non-taxable, non-income stipend provided to our low income
volunteers. While the stipend has not increased since January, 1998;
the increase in the cost-of living since then has caused the costs of
volunteering to escalate dramatically, especially the price of gasoline
and other costs associated with daily transportation. We believe that
the current stipend of $2.55/hour is no longer adequate to cover the
costs associated with volunteering.
the administration's fiscal year 2001 request for senior demonstration
Although fiscal year 2000 appropriations conference and bill
language has effectively stopped the payment of a non-taxable, non-
income stipend to people whose incomes exceed the income eligibility
requirements set in the DVSA for FGP and SCP, the administration is
again requesting demonstration funds to continue to pay RSVP Leaders in
fiscal year 2001, using the rationale that RSVP has no statutory income
requirements for its volunteers. We are very aware that Congress
intended to exclude from those receiving a non-taxable, non-income
stipend all FGP, SCP and RSVP volunteers whose incomes exceed the
income requirements set in the DVSA for FGP and SC (125 percent of the
national poverty level). Both NAFGPD and the National Association of
RSVP Directors believe the Administration's request is a flagrant
violation of the intent of Congress as expressed in fiscal year 2000
appropriations law, and should not be funded.
The Administration also requests demonstration funds for grants to
national organizations to develop plans to use more senior volunteers
to further their missions. We believe that these challenge grants will
be used by the national organizations to implement programs that will,
in essence, be the beginning of a 4th senior volunteer program that
will use non-federal funds to continue the practice of paying non-
taxable, non-income stipends to people meeting no income eligibility
requirements.
NAFGPD is not opposed to demonstration efforts which will improve
the way FGP, SCP, or RSVP deliver services, or which will help to test
innovative program and volunteer activities which will improve the
existing programs. We are opposed to demonstration activities that will
be used to start a 4th--and totally unnecessary--senior volunteer
program, especially one designed to pay volunteers who can afford to
volunteer without a financial enabler. We are also opposed to using
scarce federal dollars to fund efforts that will in no way improve the
three existing senior volunteer programs. In fact, this new 4th program
will actually duplicate the services performed by the 25 year old RSVP
program, which now engages nearly \1/2\ million volunteers who serve
without any payment at all! The federal demonstration dollars requested
by the Administration for national organizations are better invested in
FGP to enable low-income seniors to serve.
nafgpd's fiscal year 2001 request for fgp and senior demonstration
Given the growing number of eligible low-income seniors and the
staggering number of troubled and challenged children in America today,
we believe that the Administration's request does not invest adequately
for the future in the Foster Grandparent Program, and actually diverts
funds which could be invested in FGP into demonstration activities we
cannot support. We ask that you (1) adopt a different fiscal year 2001
funding allocation for FGP, one which will more properly address the
important role our programs must play in engaging more of our nation's
low-income elders in addressing serious community needs in more
communities nationwide; and (2) refrain from appropriating any federal
dollars to senior demonstration. Our fiscal year 2001 request is as
follows:
[In millions of dollars]
Foster Grandparent Program.................................... 107.177
Senior Demonstration....................................................
This request represents an $11.189 million increase over
FGP's fiscal year 2000 level. We also request that the
Committee include report language accompanying the fiscal year
2001 funding measure which supports and specifies the following
allocation priorities for use of the fiscal year 2001 increase:
First, for the Foster Grandparent and Senior Companion
Programs, increase the stipend which enables low income
volunteers to serve from $2.55/hour to $2.65/hour. Funds should
be available to pay for the additional $.10 per hour for non-
federally funded volunteers for one year;
Second, award an administrative cost increase of 3 percent
to each existing FGP in order to maintain quality and sustain
the work already being done by programs;
Third, allocate funds for the $1.1 million requested by the
Administration to allow programs to increase their
technological capabilities to meet standards set by CNS;
Fourth, in accordance with the Domestic Volunteer Service
Act (DVSA), use 1/3 of the increase over the fiscal year 2000
level to fund Program of National Significance (PNS) expansion
grants to allow existing FGP programs to expand the number of
volunteers serving in areas of critical need as identified by
Congress in the DVSA; areas which may not be limited to America
Reads activities, and with no minimum or maximum grant size
specified by CNS;
Finally, begin 20 new Foster Grandparent Program projects
in geographic areas currently unserved.
This funding proposal will generate opportunities for more
than 4,000 new low-income senior volunteers contributing in
excess of 4.1 million hours of service annually to more than
15,900 additional children. In addition, 20 more communities
will receive the multifaceted services of FGP, a small step
toward NAFGPD's fiscal year 2000 goal of beginning 100 new
Foster Grandparent Programs nationwide by 2004.
A New York Times article (March 21, 1999) on volunteers and
retirement stated that ``. . . Thousands of older people are on
the waiting list for the Foster Grandparent program, in which
25,000 older adults whose income is below the poverty line
receive a small stipend for volunteering 20 hours a week to be
grandparents for disabled or disadvantaged youngsters. Many
young people need mentors and foster grandparents, but lack of
money precludes more participation.'' Our experiences strongly
support this statement. In communities that already have a
Foster Grandparent Program, unfilled requests from local
organizations for more Foster Grandparents are the rule, not
the exception. And when Congress provided funds for 25 new
Foster Grandparent Programs in fiscal year 1998--the first new
programs in 18 years--125 high-quality applications were
submitted by local community organizations nationwide.
In addition, a 1998 AARP survey conducted by Roper Starch
Worldwide indicated a ``sea change'' in retirement patterns:
the majority of ``babyboomers'' intend to continue to keep
their jobs and never retire from work! The 1998 Independent
Sector study showed that seniors who are still working are more
likely to volunteer on an informal basis than to volunteer in a
program like FGP that requires a commitment of 20 hours of
service every week. It will be the ``boomers'' who have not
acquired the skills needed to keep their jobs as they age or
who have worked at low-paying jobs who will be available to
volunteer every day, who will need FGP to provide them with
opportunities to stay active.
Please help us tap one of the nation's only increasing
national resources--our low-income seniors--by supporting a
total fiscal year 2001 appropriation of $107.177 million for
the Foster Grandparent Program, and allocating no funds to
senior demonstration for fiscal year 2001.
------
Prepared Statement of the American Museum of Natural History
Thank you, Mr. Chairman, for allowing me to testify before the
Subcommittee today. My name is Craig Morris, and I am speaking on
behalf of the American Museum of Natural History and in support of the
Institute of Museum and Library Services.
about the american museum of natural history
Founded in 1869, the American Museum of Natural History [AMNH] is
one of the nation's preeminent institutions for scientific research and
public education. Throughout its history, the Museum has pursued its
joint missions of science and education, of examining critical
scientific issues and educating the public about them. It is renowned
for its exhibitions and collections, which serve as a field guide to
the entire planet and present a panorama of the world's cultures.
Museum collections of some 32 million natural specimens and cultural
artifacts provide an irreplaceable record of life on earth. Its
explorers and scientists have pioneered discoveries and offered us new
ways of looking at nature and human civilization. The Museum's power to
interpret wide-ranging scientific discoveries and convey them
imaginatively has inspired generations of visitors to its grand
exhibition halls and educated its three million annual visitors--
500,000 of them schoolchildren--about the natural world and the
vitality of human culture.
Since 1887 the Museum has sponsored thousands of expeditions,
sending scientists and explorers to every continent; currently more
than 100 field projects are conducted each year, including ongoing
research in such countries as Chile, China, Cuba, Madagascar, Mongolia,
and New Guinea. Some of the most influential scientists of the
twentieth century, including Margaret Mead, George Gaylord Simpson, Roy
Chapman Andrews, and Ernst Mayr were either staff members of or
affiliated with the Museum.
Today more than 200 active Museum scientists with internationally
recognized expertise, led by 47 curators, conduct laboratory and
collections-based research programs as well as field work and training.
Scientists in five divisions (Anthropology; Earth, Planetary, and Space
Sciences; Invertebrate Zoology; Paleontology; and Vertebrate Zoology)
are sequencing DNA and creating new computational tools to retrace the
evolutionary tree, documenting changes in the environment, making new
discoveries in the fossil record, and describing human culture in all
its variety. The Museum also conducts graduate training programs in
conjunction with a host of distinguished universities, support doctoral
and postdoctoral scientists with highly competitive fellowships, and
offer talented undergraduates an opportunity to work with Museum
scientists.
In many ways, the AMNH is similar to a research university, with
its scientific faculty from diverse fields such anthropology, earth and
planetary sciences, astrophysics, and all branches of zoology. Yet the
Museum is distinct in that its mission extends beyond research and
training. Museum curators are also deeply engaged as exhibition and
education advisors and as caretakers of the Museum's ever growing
collections. They help to promote public understanding of science, of
where we come from and where we may be headed.
In exhibitions, which are among the Museum's most potent
educational tools, AMNH scientific knowledge and discovery are
translated into three dimensions. The Museum is proud to continue its
tradition of creating some of the world's greatest scientific
exhibitions. Last month, in one of the most exciting chapters in the
Museum's long and distinguished history of advancing science and
education, it opened the spectacular new Rose Center for Earth and
Space. The Rose Center includes a newly rebuilt and updated Hayden
Planetarium that allows visitors to journey among the stars and planets
in our own and in other galaxies; and the Lewis B. and Dorothy Cullman
Hall of the Universe, where interactive technology and participatory
displays elucidate important astronomy and astrophysics principles. The
adjoining Gottesman Hall of Planet Earth, which opened in 1999,
explores the processes that determine how the Earth works; it in turn
leads to the recently opened Hall of Biodiversity. Together, the new
planetarium and halls provide visitors a seamless educational journey
from the universe's beginnings to the formation and processes of Earth
to the extraordinary diversity of life on our planet.
The Museum's Education Department spearheads the AMNH's commitment
to promoting public education, particularly in an informal setting. It
builds on the Museum's unique resources to offer rich educational
programming dedicated to increasing scientific literacy, to encouraging
students to pursue science and museum careers, and to providing a forum
for exploring the world's cultures. The Department targets its efforts
particularly to New York City's diverse and often underserved
communities and school districts, to those populations traditionally
poorly served by schools, those underrepresented in science, and those
for whom museums typically are not a welcoming destination.
Each year hundreds of thousands of students, teachers, and schools
participate in workshops, courses for college credit, and visits to the
Museum. Annually, more than 500,000 students and teachers visit on
school trips, prepared and supported by curriculum resources and
workshops. For schools that cannot get to the Museum, Moveable Museums
offer off-site access, free of charge. As well, Education Department
lectures, field trips and workshops on subjects ranging from birding to
earthquakes, gospel music to Native American culture, and Hudson River
geology to gorilla conservation attract large audiences of adults,
children, and families.
In 1997 the Museum launched in partnership with NASA the National
Center for Science Literacy, Education, and Technology to advance
science literacy throughout the United States and to extend the
Museum's educational reach and impact to a national audience, including
local communities. In creating the National Center, the Museum and NASA
recognized an opportunity to combine and leverage their incomparable
resources, and through new technologies to bring learning and
discovery, materials, and programs into homes, schools, museums, and
community organizations around the nation.
support for the institute of museum and library services
The American Museum of Natural History supports the goals and
accomplishments of the Institute of Museum and Library Services [IMLS].
The Museum's own collections of more than 32 million artifacts and
specimens are considered to be the largest non-federal Museum
collection in America, and one of the largest and most significant
biological collections in the world. Its Library houses one of the
world's preeminent collections of natural history and anthropology
materials. It shares IMLS commitments to increasing technological
access to the nation's museum and library resources and to building
partnerships to address community needs; and it urges increased
investment in IMLS so as to advance public access to these vital
educational institutions.
Scientific and Cultural Collections
The cumulative result of 130 years of exploration, collecting, and
research, the AMNH collections are a major scientific resource
providing the foundation for the Museum's interrelated research,
education, and exhibition missions. Those collections are organized
around the departments of Entomology, Herpetology, Ichthyology,
Invertebrates, Mammalogy, Ornithology, and Vertebrate Paleontology.
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 collections are many spectacular
individual collections, including the world's most comprehensive
collections of dinosaurs; fossil mammals; Northwest Coast and Siberian
cultural artifacts; North American butterflies; spiders; Australian and
Chinese amphibians; reptiles; fishes outside of their home countries;
and one of the most important bird collections. Collections such as
these are historical libraries of expertly identified examples of
species and artifacts, associated with data about when and where they
were collected. Such collections provide essential baseline data for
Museum scientists as well as more than 250 national and international
visiting scientists each year. And the collections are all located on-
site to allow scientists' with ease of access.
The Museum's halls of vertebrate evolution provide an excellent
example of the relationship among science, collections, education, and
exhibition. In these halls, visitors walk directly along a phylogenetic
tree indicated by a pathway on the floor. At each branch in the tree, a
visitor can stop and view fossils that exemplify sets of anatomical
features that inform scientists about natural groups of organisms. The
collections are also the source of the extraordinary ``Spectrum of
Life'' exhibit in the new Hall of Biodiversity. This exhibit features
more than a 1,000 expertly mounted specimens from 28 scientific
classifications; it is perhaps the world's most comprehensive display
of the diversity and evolution of life. It includes interactive
computer kiosks that visitors use to identify and interrelate organisms
on evolutionary trees. The confluence of collections, evolutionary
research, and beautiful exhibition makes these halls among the Museum's
most compelling educational features.
Natural History Library
The American Museum of Natural History is also home to the largest
unified natural history library in the Western Hemisphere. In addition
to supporting the work of the Museum's scientific staff, the Library
serves the world's scientific and scholarly communities as well as
students from the colleges and universities in the tri-state area and
interested members of the public. Each year thousands of users visit
the Library, and its staff answer more than 26,000 reference questions.
The Library contains over 485,000 volumes, including pamphlets,
reprints, books, journals, photos, several hundred films, and rare
books dating to the fifteenth century. It also houses the Museum's
astronomy collections, including the Perkins Library of more than
35,000 volumes and the Bliss Collection of rare and ancient scientific
instruments. The archives contain more than 1,900 linear feet of
materials and 250 reels of microfilm. Additionally, the Library
maintains approximately 1,000,000 photographic images documenting
specimens and scientific work, 3,000 documentary films, and over 2,700
art objects and memorabilia.
Other highlights of the Library collection include over 300
manuscript collections of notable naturalists and scientists; a unique
collection of 13,000 rare books that spans over 500 years of scientific
and expedition literature; and diaries and logs, including Captain
James Cook's account of Australia (1783) and Charles Darwin's zoology
of the voyage of ``H.M.S. Beagle'' (1839-1843).
Preservation and Access
By assuming stewardship of these irreplaceable Library holdings and
scientific collections, the Museum serves as custodian of one of the
most important records of life on earth. And as steward and custodian,
it places the highest possible priority on preservation and access, so
that the collections will be protected and available for research, for
exhibit, and for education for generations to come.
The Library is engaged in a major pilot effort, with private
foundation support, to digitize its holdings and link them to the
scientific collections. This model project, illustrative of the
digitization initiatives the IMLS supports, will help to pave the way
in transforming access to and ways to use the Museum's collections and
holdings. An expansion of the digitization project would increase
access enormously for researchers, students, teachers, and the general
public to the Museum and Library holdings.
The Museum has also undertaken major efforts to improve storage,
preservation, and access of its vast collections. This year Museum
departments will move into a new nine-story Natural Science Building.
This facility will significantly increase exhibition and collections
storage space, with 30,000 sq. ft. of climate-controlled compact
storage facilities for portions of the scientific collections, along
with a digital imaging laboratory.
The Anthropology Division is also nearing completion of a 25-year
collection storage upgrade and related digitization project. Scheduled
for completion in 2002, and with support from the National Endowment
for the Humanities, this upgrade will ensure scholarly access to these
vital and magnificent collections. The new digital image database and
accompanying electronic catalog will facilitate access for staff,
visiting scholars, and off-site researchers.
biological collection storage upgrade and digitization project
With the successful Anthropology storage upgrade and digitization
project nearly complete, the Museum now turns its focus to critical
improvement of other storage facilities and to digitizing the
biological collections for upgraded preservation and wider access. The
IMLS has a distinguished history of supporting cutting edge collection
and technological practices. We do seek partnerships with IMLS that
will allow us to provide leadership in collection practices and serve
as a national model in improving public access to museum and library
resources through technology.
Technological Innovation for Greater Public Access
Biological science at the Museum centers on expert documentation of
species and investigation of their evolutionary and ecological
relationships. The collections therefore provide essential baseline
data for scientific inquiry. Due to the unparalleled interest in the
Museum's biological collections and unwieldliness of the specimens,
comprehensive digital imaging and electronic cataloging of many of
these collections will allow the Museum readily to share our resources
through technology with a national and international audience. We would
like to develop a database, with a web front end for worldwide general
audience access, to allow digitized specimens and field data to be
searched across many fields (for instance, by locality or age).
Detailed digital renderings would allow ready and safe access to often
fragile archival material and allow off-site researchers and users to
peruse the collection and strategically plan Museum visits. These last
two matters are key. If using the database can help researchers can
plan Museum visits, the productivity of their visits will be
significantly enhanced.
Collection Storage Facilities
Collections preservation and access are top Museum priorities. The
Museum's collections are the heart and soul of our scientific research,
permanent and temporary exhibitions, and education programs. Access to
the collections allows undergraduate, graduate, post-graduate, and even
high school students to conduct real research projects in intensive
learning programs. As the collections grow, questions about how to
curate them, including how to use limited physical storage space,
arise. While many similar institutions house their collections
separately from their faculty, the Museum is committed to keeping its
scientists, educators and collections together by expanding on site.
The new Natural Sciences Building, for example, can accommodate a
substantial amount of new compact storage, including a unique super-
cold storage facility to allow for the preservation of tissue samples
for future of DNA study.
As these endeavors demonstrate, the American Museum of Natural
History supports the important goals of IMLS to preserve and expand
access to library and museum resources and to reach out to broad
audiences and diverse communities.
______
Prepared Statement of the Colonial Williamsburg Foundation
Chairman Specter and members of the Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies, I want to thank you for the opportunity to submit the
following two proposals that we at Colonial Williamsburg are excited
about and feel could help to re-calibrate our national compass and
engage future generations in a stimulating discussion about the basic
principles of democratic government that have made this country a world
leader.
You may know Colonial Williamsburg as John D. Rockefeller, Jr.'s
famous restored eighteenth century town. But the significance of this
town goes far beyond the bricks and cobblestones. We are the nation's
largest outdoor living museum. Our conservancy museums have one of the
largest collections of eighteenth century Antiquities in the world.
There are over 600 original and restored eighteenth century buildings
in our 173 acre Historic Area. We also have a large and talented
interpretive staff who can bring American history and the democratic
principles of our forefathers to life in a fun and stimulating learning
environment. Quite simply, Colonial Williamsburg is an educational
institution. Its significance is both public and personal, educational
and experimental. Its mission is to tell the story of a diverse group
of people who fought to create a new community in a new land, based on
new ideals.
Our living history approach creates the environment of the past--a
colonial town--and populates the streets, homes, and shops with
costumed interpreters. Visitors can actually touch history. They can
talk with tradesmen, ask them questions, and examine their crafts. They
can sit as a local magistrate at the colonial county courthouse. They
can eat a meal in an authentic eighteenth century colonial tavern, help
make bricks for the foundation of a house, even engage in a political
discussion with George Washington, Thomas Jefferson, or the royal
governor. They hear the echoes of Patrick Henry's denunciation of the
Stamp Act resonate throughout the halls of the Colonial Capitol.
Visitors can literally immerse themselves in the past. The result is a
dynamic method of history education that generates an excitement for
learning about the ideas and principles upon which our democracy is
based.
Over three million people visit our site each year from all 50
states and from many other countries. But our goal of fulfilling
Jefferson's objective of an educated populace does not stop with just
those guests who are able to visit Colonial Williamsburg in person.
Colonial Williamsburg has long been the leader in providing
distance learning with a variety of educational programming activities
for over fifty years. Today, with the best technological communication
resources at our command, we are able to reach millions of students and
teachers throughout the country through broadcast, internet,
interactive media and digital satellite. One of the results of these
advances in technology is our award winning Electronic Filed Trips that
allow students and teachers to ``visit'' Williamsburg via interactive
television programs, while our www.history.org web site offers
convenient access to our educational and research resources on the
Internet.
Our Electronic Field Trips provide a live, interactive format by
Colonial Williamsburg to over one million registered students. These
programs are also viewed by another three million students on a delayed
basis courtesy of local PBS stations. We provide seven Electronic Field
Trip programs each year. The programs deal with a variety of topics
from methods of travel in the eighteenth century, to slavery,
apprenticeships, and indentured servitude, to tradesmen rebuilding the
houses and structures of Colonial Williamsburg. Schools that register
for the program receive printed lesson plans, resource materials,
internet activities, and other materials to prepare students during the
month preceding the program. The program comes live into the classroom
and registered students can phone in questions to interpretive staff
who appear in the program segment. Over 30 other interpretive and
research staff take calls, email, and internet messages and respond to
the students. Material remains on our web site for 30 days after the
program. During one of our most recent programs, over 1,300 calls from
across the country were received.
While we currently reach over four million students with these
award-winning, state-of-the-art programs, we feel we have an obligation
to help more schools and students meet national standards of learning.
We have been informed that in schools using the Electronic Field Trips
these scores have gone up. The programs address more than just history
SOL's--they cover science, math, and other subjects as well.
We would like to be able to offer our Electronic Field Trips, free
of charge to an additional 10,000 schools across the country. This
would mean reaching an additional five million students a year. We have
already developed the facilities and the high tech programmatic
infrastructure for these programs. We have proven how successful they
can be in exciting and educating students. We believe that if we can
reach these additional 10,000 schools, the programs will become self-
supporting. We believe we can convince these schools and others that
the seven programs are worth $500 a year. As stewards of an important
segment of our American heritage, we are asking for a one-time
appropriation of $3 million to reach an additional five million
students and to help students, teachers, and schools in all 50 states
provide the type of state-of-the-art programs that teachers want and
that will use twenty-first century technology to develop an
understanding in the students of timeless eighteenth century
principles.
We want to expand our educational programs to many more areas and
students across the country. The Electronic Field Trips offer
stimulating, state-of-the-art, fun, yet challenging programs. They have
allowed millions of students and teachers to learn and understand the
events that have shaped the nation's history. They also ensure we keep
alive John D. Rockefeller Jr.'s goal for Colonial Williamsburg ``that
the future may learn from the past.''
You may accuse me of bias, but I believe Mr. Rockefeller would be
proud of our educational programs. He would also encourage us to do
more with his vision in mind. The advent of the twenty-first century
provides an appropriate time to reflect on America, the democratic
values that have influenced representative government, and the legal
principles that have always protected a free society. Indeed, the onset
of the new century in an opportune time to focus on the History of
America.
Responding to the challenge to learn from the past and prepare new
generations of American leaders, the College of William and Mary and
Colonial Williamsburg, two of the most prestigious educational
institutions in America and preeminent stewards of early American
history, are collaborating to establish a unique and challenging
residential program for scholarly historical research at Virginia's
Colonial Capital. We are tentatively calling it the Institute of
American History and Democracy.
The goal of the institute will be to assist the nation in re-
calibrating its internal compass to enhance the understanding of
college and high school students in our nation's historic journey and
to encourage the ongoing review of America's founding principles. The
Institute would be open to visiting undergraduates from colleges and
universities across the United States and from the international
community. Academic credit would be provided by the College of William
and Mary.
Joint William and Mary and Colonial Williamsburg faculty, as well
as nationally-recognized historians would develop the curriculum and
present the courses. Course topics would include early American
history, constitutional history, governmental institutions, social
history, military history, archeology, and museum-related fields.
During the summer, this joint faculty would provide a similar
program of courses for outstanding high school students from across the
country. Summer high school students would be able to earn advance
college credit for these courses. Colonial Williamsburg has been
providing a similar program for teachers for the last ten years. Our
Teacher Institutes have helped to avoid teacher burnout and have
instead rekindled the passion for history and raised the teaching
skills of those attending, several of whom have later been named
teacher of the year in their states.
Both Colonial Williamsburg and the College of William and Mary have
developed some of this country's most advanced and interactive methods
of education. College and high school students who attend the proposed
Institute would become involved in interactive and hands-on learning
experiences, as well as being exposed to extensive original research
materials. These teaching methods along with state-of-the-art
technology will engage the students and bring history alive. It is our
hope that the curriculum developed for the Institute could also be
adapted to our outreach capabilities and thereby made available to an
even wider audience.
We are seeking a one-time award of $5 million to cover the initial
start-up costs for the Institute including curriculum development,
staff training, program marketing, and facility modifications. Housing
will be provided by Colonial Williamsburg at existing facilities.
Classroom space will be provided by Colonial Williamsburg and the
College of William and Mary at existing facilities. Once established,
the program will be self-supporting through tuition and private
donations.
I should note that Colonial Williamsburg has never sought this type
of federal funding support before. We are seeking this assistance now
because we believe these two programs will add significantly to future
generations' understanding of basic democratic principles and will help
to keep those principles alive and well for many generations to come.
We want to help keep the ship of state pointed in the right direction
by ensuring all of our citizens understand and can apply the basic
principles and ideals of democracy that were established in this
country in the late 1700's by the founders of our nation.
Again, thank you for the opportunity to submit what we believe are
two very exciting proposals. We hope you will agree and will help us
make them a reality.
______
Prepared Statement of the National Minority Public Broadcasting
Consortia
The National Minority Public Broadcasting Consortia (Minority
Consortia) submits this statement on the fiscal year 2003 appropriation
for the Corporation for Public Broadcasting (CPB). Our primary missions
are to bring a significant amount of programming from our communities
into the mainstream of PBS and public broadcasting. In summary, we
request that the Committee support:
--The Administration's request of $365 million for CPB for fiscal
year 2003, a $15 million increase over fiscal year 2002;
--The Administration's request of $20 million in CPB fiscal year 2001
funds for digital conversion; and we request that some of this
funding be available to independent minority producers for
conversion to digital production;
--With regard to the Minority Consortia and multicultural programming
we request that the Committee support--
An increased allocation of CPB program funds to expand our
programming, including a 15 percent increase in the
Multicultural Program Fund (currently at $3.2 million)
which we administer;
An increased allocation of CPB system support funds to expand our
administrative capacity, at an amount at least commensurate
with the overall CPB increase;
Increased CPB outreach efforts to promote the multicultural
television productions expected to air on PBS this year.
The National Minority Public Broadcasting Consortia consists of the
National Asian American Telecommunications Association, the National
Black Programming Consortium, Native American Public
Telecommunications, Pacific Islanders in Communications and the Latino
Public Broadcasting Project.
A federal appropriation of $365 million as requested by the
Administration for CPB would be a reasonable, albeit modest,
contribution toward our national treasure of public broadcasting. The
debate of the past several years regarding public television and public
radio has highlighted the great esteem in which they are held. We urge
Congress to provide at least as much as has been requested by the
Administration for CPB for fiscal year 2003.
Public broadcasting, including PBS and NPR, is particularly
important for minority and ethnic communities. While there is a niche
in the commercial broadcast and cable world for quality programming
about our communities and our concerns, it is in the public
broadcasting industry where minority communities and producers are more
able to bring quality programming for national audiences. Additionally,
public television and radio is universally available. In 1994, CPB
initiated research among Asian American and Native American communities
which documented that respondents felt their communities were
negatively stereotyped on commercial television and that that PBS had
more realistic portrayals. (REACHING COMMON GROUND: PUBLIC
BROADCASTING'S SERVICES TO MINORITIES AND OTHER GROUPS, July 1, 1994,
pages 41-41 of the Appendix). This survey also revealed that both
groups wanted increased visibility in public television and further
recommended that there be expanded promotion of public broadcast
programming utilizing Asian American and community groups and tribal
organizations. Earlier CPB surveys of Latino and African American
communities showed similar findings.
This is the Optimum Time to Increase Resources for CPB's Mission of
Diversity.--The Minority Consortia works closely with CPB. We value our
relationship with President Coonrod and the CPB staff and appreciate
the financial and technical assistance provided to us by that
organization. We do not doubt CPB's commitment to increasing the
diversity of programming on public television and radio, but also
believe they can do more with the resources at hand. The stated
commitment of CPB and Congress for increased multicultural programming
combined with three years of funding increases make this an ideal time
for significant progress. It may be now or never.
Since 1988, ten Congressional authorizing and appropriations
reports have expressed support for the Minority Consortia and/or for
increased multicultural programming on public television.
The CPB fiscal year 2000 funding received by the Minority Consortia
organizations--$1.53 million for institutional support ($307,000 per
organization--a $28,000 increase per organization over fiscal year
1999) and $3.2 million in programming funds ($636,000 per
organization)--is certainly modest compared to the cost of producing an
increased amount of quality multicultural programming for public
broadcast. Our programming and administrative support funding combined
is 1.56 percent of the CPB fiscal year 2000 budget (Fiscal years 2001
and 2002 funds have not yet been distributed). We appreciate that CPB
has identified an additional $2.5 million in program funds which we,
along with others, can compete, but the commitment for diverse
programming should be larger than that.
The Minority Consortia shared in the CPB fiscal year 1997 and 1998
budget reductions. Now, however, we are in a period for which Congress
has appropriated increased funding for CPB. The CPB fiscal year 2001
appropriation, which has not yet been distributed, is $340 million, a
$40 million increase over fiscal year 2000. And the fiscal year 2002
appropriation is $350 million, an increase of $10 million over fiscal
year 2001.
The testimony of CPB President Bob Coonrod before this Subcommittee
on March 28, 2000 discussed the need to increase the diversity of
public broadcasting offerings, including multicultural programming. He
also noted that the younger segment of our society is even more
ethnically diverse than the older population. We applaud CPB's public
discussion of this need, and intend to work collaboratively with them
and the entire public broadcasting community to help make this a
reality. But in order to do this, the amount of funding allocated for
the development of multicultural programming must substantially
increase. And at a minimum, the administrative funding for the
Consortia should increase commensurate with the overall CPB budget (a
proposed 4.2 percent increase for fiscal year 2003).
Audience Building.--We ask your support in encouraging CPB to
increase its efforts to build audiences for PBS programs presented by
the Minority Consortia. The good news is that number of programs
presented by the Minority Consortia on public television are
increasing. On the other hand, the small administrative an program
budgets of the Minority Consortia are not sufficient to do the kind of
community and national outreach we would like for building audiences
for these programs. Obviously, we engage in audience building, but much
more can and should be done.
The most recent shows on national public television from the
Minority Consortia organizations include regret to inform, homecoming--
sometimes I am haunted by memories of red dirt and clay, and warrior in
two worlds.
Digital Conversion Assistance.--Much attention was given at the
March 28, 2000 House appropriations hearing regarding the opportunities
which digital technology will provide in the area of programming. With
stations able to broadcast on multiple channels, there will be a need
for a tremendous amount of new, quality public broadcasting
programming. There are costs involved in the conversion which go beyond
the significant equipment and hardware needs of stations. It will also
take additional money to produce programming for digital broadcast. All
producers will face these new, higher costs. Film producers will need
to use equipment that is high definition quality, and that is an
expensive proposition. Most producers with whom we work do have not the
finances for this new equipment. CPB is currently providing some
technical assistance to producers regarding digital conversion.
However, independent producers also need financial assistance in
acquiring or accessing the means to produce programming for digital
broadcast.
We also point out that the Minority Consortia organizations are
jointly seeking non-federal sources of funding to support digital
production for independent producers, and like their counterparts in
public television and radio stations, independent producers also need
federal assistance to make this transition.
Work of the Minority Consortia.--The Minority Consortia
organizations work both individually and collaboratively. In the past
twenty years the Consortia organizations have individually provided to
public broadcasting's schedule hundreds of hours of programming
addressing the cultural, social and economic issues of the country's
racial and ethnic communities. Individually, each Consortia
organization has been engaged in cultivating ongoing relationships with
the independent producers community by providing technical assistance,
program funding, programming support and distribution. We also provide
numerous hours of programming to individual public television and radio
stations.
On the collaborative front, the five organizations comprising the
Minority Consortia are working to jointly write and publish a catalog,
newspaper ads, Open Calls for Proposals, and a newsletter.
Perhaps of most potential significance is our planned joint
production of a four-part series which will explore the complex demands
of our rapidly changing multiracial, multicultural society in America.
We will work with many film producers and with CPB and PBS on the
production, and CPB will provide some financial assistance. The
production is entitled Matters of Race, and we have engaged noted
producer/writer Orlando Bagwell (Malcom X: Make it Plain, Eyes on the
Prize, A Hymn for Alvin Alley, Fredrick Douglass: When the Lion Wrote
History) to produce this series. The project will result in more than
television programming. The project will utilize an advisory group of
teachers and will be designed so that modules that can be pulled out
for classroom use. It will also be formatted for radio broadcast and
for the internet, and will include such broadcast applications as
extended interviews. There will be great opportunity for extensive and
diverse community outreach and collaboration on this project throughout
its development, distribution and use.
Currently the five consortia groups are in discussion with other
public broadcast entities to pool and share resources to increase
awareness of PBS's and public broadcasting diversity initiative. Some
of these collaborations include centralizing program distribution with
American Public Television, creating minority outreach for stations
with the Public Television Outreach Alliance, and working with CPB and
PBS to formulate a long range strategy for minority programming for
public broadcasting. The Minority Consortia organizations work
collaboratively with a number of television stations, and hope to
increase such working relationships.
Thank you for your consideration of our recommendations. We see new
opportunities to increase diversity in programming, production,
audience, and employment in the new media environment, and we as
minority communities in public broadcasting thank you for your long
time support of our work on behalf of our communities.
______
Prepared Statement of the National Congress of American Indians
introduction
Good morning Chairman Specter, Senator Harkin and distinguished
members of the Appropriations Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies. My name is Susan Masten and
I am the President of the National Congress of American Indians (NCAI),
the oldest and largest Indian advocacy organization in the United
States and Chairperson of the Yurok Tribe. On behalf of the 250 member
tribes of NCAI, I would like to thank you for this opportunity to
submit this statement regarding the President's budget request for
fiscal year 2001.
NCAI is extremely optimistic about this year's budget process. For
the first time in a generation, the President has requested a total of
$9.4 billion for new and existing Indian programs. If preserved through
the appropriations process, this request will provide an increase of
$1.2 billion over the fiscal year 2000 budget. The last time the
Federal Government enacted an increase of a similar scope, was in the
mid-1970's, as a part of President Nixon's Tribal Self-Determination
policy. The President's fiscal year 2001 budget request represents a
commitment to Indian programs and will better serve Indian communities.
It also exemplifies a meaningful step toward honoring the Federal
Government's treaty and trust obligations to Indian nations. As
Congress advances the appropriations process for fiscal year 2001, NCAI
seeks support from this Subcommittee to fully fund the Indian programs
in the Departments of Education, Health and Human Services, and Labor.
department of education
For fiscal year 2001, the President's budget request for the
Department of Education Office of Indian Education (OIE) is $116
million, a 50 percent increase over the fiscal year 2000 enacted level.
NCAI fully supports this request as it will allow the Department's OIE
to fund formula grants to Local Education Agencies (LEAs), fund new
discretionary programs for OIE, and start a new program for American
Indian administrators. Additionally, NCAI fully endorses the
Administration's effort to fund the initiatives under the 1998
Executive Order on Indian Education.
For fiscal year 2001, $92.8 million is requested for OIE's formula
grant program to public schools, an increase of $30 million over fiscal
year 2000. These funds are provided to BIA supported schools for the
improvement of educational achievements of Indian students by allowing
for the initiation and expansion of Indian specific programs and
services. Within the fiscal year 2001 requested budget is a $20 million
request for Special Programs, an increase of $6.7 million over fiscal
year 2000, for awards for school readiness demonstrations, educator
professional development grants, and continuation of the American
Indian Teacher Corps. NCAI supports President Clinton's commitment to
recruit and train 1,000 new Indian teachers over a five-year period who
will then teach in schools with high concentrations of Indian students.
Additionally, the President has requested $5 million for the American
Indian Administrator Corps. Within the President's fiscal year 2001
proposed budget for Higher Education, $40 million has been requested
for a new dual degree program. NCAI strongly supports these funding
initiatives to advance Indian education and develop an educational
system responsive to the needs of Native students and teachers.
department of health and human services
The fiscal year 2001 budget requests $44 million for the
Administration for Native Americans (ANA), an increase of $9 million
over the fiscal year 2000 enacted level. In awarding grants in fiscal
year 2001, ANA will give special attention to energy development and
the creation of tribal codes and ordinances. NCAI urges Congress to
support this much-needed increase that will support tribal government
infrastructure and increase tribal government capacity to administer
programs.
The fiscal year 2001 request for the Administration for Children
and Families (ACF) Federal Administration line-item is $165 million, an
increase of $17 million over fiscal year 2000. From this total, funding
is provided to the Division of Tribal Services (DTS). The DTS provides
programmatic support to 22 tribal TANF programs, which directly affects
94 tribes and Alaska Native villages. It is estimated that by fiscal
year 2001, approximately 50 percent of all federally-recognized tribes
will either administer or be served by a tribal TANF program. While the
ACF has tried to provide necessary funding to carry out these duties,
without line-item funding authorization for the DTS, the increasing
needs of Indian tribes surrounding these social support programs will
not be met. NCAI requests a $10 million line-item funding for DTS.
While the fiscal year 2001 budget requests $2 billion for the
discretionary Child Care Development Block Grant (CCDBG), an increase
of $817 million dollars over the fiscal year 2000 enacted level, tribal
governments, who receive a 2 percent set aside of the CCDBG, will still
fall far short of meeting child care needs on their reservations. There
is a critical need for safe, healthy, nurturing child care
environments, particularly on Indian reservations, where parents have a
higher median number of children than the national average. NCAI
request an increase in tribal child care funding from its current level
of 2 percent of the total appropriation.
The fiscal year 2001 budget boosts funding for Head Start by $1
billion in fiscal year 2001, the largest funding increase ever. The
budget also provides a total of $175 million, including a $30 million
increase over fiscal year 2000, for Indian Head Start. NCAI strongly
supports this much-needed increase to Indian Head Start programs, many
of which are stretched to capacity.
Three provisions under the purview of the Administration on Aging,
authorized in the Older Americans Act (Pub. L. 89-73, as amended), are
of special importance to American Indian and Alaska Native elders. The
first is Aging Grants for Native Americans authorized in Title VI. The
President's fiscal year 2001 budget requests $24 million, an increase
of $5 million over the fiscal year 2000 enacted level, for Title VI
grants to tribes and tribal organizations. Current grantees report a 20
percent increase in the number of elders eligible for the service
between 1996 and 1999. Because of this growing population of Native
elders, NCAI requests that the full $30 million authorized for Title VI
be appropriated in fiscal year 2001.
The second provision is Aging Research and Training, also
authorized in Title VI. For fiscal year 2001, NCAI requests an
appropriation of $630,000 with at least $130,000 earmarked for a
continuing grant to NICOA to gather information on Indian elders and to
quantify their needs. The remainder should be directed to grants for
training Title VI service providers to better serve Indian elders.
The third provision is ombudsman/elder abuse prevention authorized
in Title VII: Allotments for Vulnerable Elder Rights Protection
Activities, Subtitle B: Native American Organization Provisions.
Prevention programs for tribes are desperately needed--yet no funds
have ever been provided for Subtitle B, despite an authorization level
of $5 million. State programs currently receive $4.5 million for
ombudsman services and $4.7 million for prevention of elder abuse
programs. However, these programs seldom, if ever, reach Indian
Country. NCAI seeks full funding of $5 million in fiscal year 2001,
specifically for tribal programs as authorized in Subtitle B of Title
VII.
In fiscal year 2001, there is a need of $600,000 for special HIV
surveillance studies to be undertaken in order to better understand the
extent of the HIV epidemic in the Native American population, and to
supplement the existing AIDS case and HIV infection data presently
available. Additionally, $200,000 is needed to contract out a series of
meetings between states, CDC, IHS, tribal representatives, and
epidemiologist to make recommendations on improving the disease
surveillance system in Native America. NCAI seeks the support of this
Subcommittee in this request.
The President's fiscal year 2001 budget request for the Centers for
Substance Abuse Prevention is $48.8 million. NCAI seeks the support of
this Subcommittee in securing a targeted funding program whose purpose
is to involve Native American substance abuse prevention treatment
programs more actively in the effort to slow the spread of HIV.
The President's fiscal year 2001 budget request for the National
Institute of Health (NIH) is $3 million. Unfortunately, there is a
shortage of funding for research related to HIV in Native America
within NIH. NCAI requests the support of this Subcommittee in seeking
critical funding for behavioral research in particular, to help better
understand the underlying components of risk behavior leading to HIV
infection in the Native American population.
department of labor
Under the Workforce Investment Act (WIA) at least $55 million can
be appropriated for the Indian Comprehensive Services program. In
fiscal year 2001, the Administration has requested $55 million. NCAI
regards WIA as an opportunity to more effectively provide job training
services and urges Congress to fully fund this program.
The fiscal year 2001 budget proposal includes $255 million for a
new ``Fathers Work/Families Win'' initiative, $10 million of which is
set aside to provide grants to help Native American low-income
families. These proposed funds are aimed at addressing the working poor
and fathers, in the aftermath of no new WtW funding. NCAI supports the
$10 million set aside for applicants from the Native American workforce
agencies.
The fiscal year 2001 budget request also provides $15 million for
the tribal supplemental youth employment services program that replaces
the former JTPA Summer Youth Program, and supports year-round
activities. In addition, the President proposes to increase the Youth
Opportunity Grant (YOG) program from its current $250 million funding
level to $375 million in fiscal year 2001. NCAI requests sufficient
funding to provide reliable and consistent opportunities for youth.
NCAI also supports adequate funding of other DOL programs that benefit
American Indians, including the Administrations's Disabilities Services
request for $43 million in the fiscal year 2001 budget. NCAI asks that
these work incentive grants and services be extend to tribes.
conclusion
Mr. Chairman, we urge the Congress to fulfill its fiduciary duty to
American Indians and Alaska Native people and to uphold the trust
responsibility as well as preserve the Government-to-Government
relationship, which includes the fulfillment of health, education and
welfare needs of all Indian tribes in the United States. This
responsibility should never be compromised or diminished because of any
Congressional agenda or party platform. Tribes throughout the nation
relinquished their lands as well as their rights to liberty and
property in exchange for this trust responsibility. The President's
fiscal year 2001 budget request acknowledges the fiduciary duty owed to
tribes. We ask that the Congress maintain the federal trust
responsibility to Indian Country and continue to aid tribes on our
journey toward self-sufficiency. Thank you for allowing me to present
for the record the National Congress of American Indians' comments
regarding the President's fiscal year 2001 budget request.
______
Prepared Statement of the National Alliance to End Homelessness
The National Alliance to End Homelessness is a national membership
organization with nearly 2,000 members around the country. Most are
local nonprofit community-based and faith-based organizations that are
doing the hands-on work to end homelessness for families and
individuals. As our name implies, our primary focus is ending
homelessness, not simply making it easier to manage. There is nothing
inevitable about homelessness in the United States. We know more about
homelessness and how to address it than we ever have before. We know
what program models are effective for what kinds of people. It remains
only to bring these solutions to a scale commensurate with the problem,
and to focus them on bringing homelessness to an end.
It is our contention that an end to homelessness is a goal that we
can achieve by the end of the decade. To do so we need to pursue four
lines of attack simultaneously. We must:
--Plan for outcomes
--Close the front door in to homelessness
--Open the back door out of homelessness and in to housing
--Build the infrastructure.
planning for outcomes
We have an extensive system for dealing with homelessness. Too
often, however, this system focuses only on managing the problem and
not on a permanent solution. To change this focus we need to be sure we
have accurate information on who homeless people are, how they become
homeless, and what works to allow them to secure and stay in housing.
We need to commit ourselves to ending homelessness as the outcome of
the system's activities. And we need to use the data to plan
strategically to bring about the result we want.
Recommendation.--Encourage all programs to collect information
about homelessness among those the programs serve. Much of the recent
explosion of information and know-how about homelessness has come as a
result of research funded by this subcommittee. This effort needs to be
extended to the state and local level.
Recommendation.--Encourage federal agencies and state governments
funded by programs such as the substance abuse and mental health block
grants to plan for reducing homelessness among the population served.
An important mandatory spending item in the Administration's budget
request is a $10 million initiative to provide money to a small number
of states to coordinate services for homeless people by programs not
specifically targeted to homeless people. The request is in the budget
for the Health Care Financing Administration, partly because Medicaid
is such an important program for homeless people. We urge the
subcommittee to encourage agencies under its jurisdiction to cooperate
with the initiative and work to make their services better coordinated
and more accessible to homeless people.
closing the front door in to homelessness
We need to hold government-funded systems accountable for, at the
very least, ensuring that the Americans they serve do not become
homeless. We must treat homelessness among people with mental illness
as sign that the mental health system needs improvement; homelessness
among former foster children as a similar sign for the child protection
system; homelessness among people with addiction disorders for the
substance abuse treatment system.
Recommendation.--Encourage mainstream programs such as the
substance abuse and mental health block grants to address homelessness
and housing stability among their target populations. Over the past few
years this subcommittee has encouraged agencies that oversee large
``mainstream'' (i.e. not homeless-targeted) programs to pay attention
to the amount of homelessness among the populations they serve. This
has led to important work by the agencies involved, to examine ways to
make these programs more conscious of housing stability as an end to be
achieved. More remains to be done, and the subcommittee should continue
its diligence in this regard.
opening the back door out of homelessness and in to housing
Most people who become homeless find housing on their own in
relatively short order. We need to speed up that process, and prevent
disruptions during the period of homelessness. A minority, however,
remains homeless for a long time. Among this group, disabilities are
prevalent, including mental illness, substance addiction, and HIV/AIDS.
This subcommittee's work can have a huge impact on efforts to
rehouse people who are chronically homeless and chronically ill.
Besides housing, they need treatment and services:
--Outreach, particularly to long-term homeless people with mental
health and substance abuse problems, to ensure that they make
use of the services that are available.
--Short-term treatment in a residential setting aimed at stabilizing
these individuals and transitioning them into permanent
housing.
--Treatment and long-term aftercare linked with permanent housing,
creating permanent supportive housing, a powerful model that
improves the lives of long-term homeless people while saving
public money that would otherwise be spent on hospital
emergency rooms, emergency detoxification, acute mental health
care, shelters and jails.
--Help with employment, as soon as homeless people are stabilized in
a residential setting.
--Case management to ensure that all services are available.
--Preparing people with few skills for success, once their housing
situation has been stabilized.
--Assistance, particularly with children, to avoid disruption of
family life during times of homelessness.
Recommendation.--Appropriate $100 million for the Grants for the
Benefit of Homeless Individuals program. This program, first authorized
in 1992, has the potential to fill the most gaping hole in the system
of supports for chronically homeless people--the lack of effective
substance abuse treatment services. The program would provide
competitive grants from the Substance Abuse and Mental Health Services
Administration to local agencies, to provide specific services for
homeless people with addictive disorders and/or mental illnesses. GBHI
would provide an ideal mechanism for linking HHS-funded services with
HUD-funded supportive housing. There is not an existing appropriation
for this program, but we request that the subcommittee pass a new
appropriation for it because it fills such a crucial need, for
substance abuse treatment and for treatment for mental illnesses that
are not considered ``severe'' (i.e. schizophrenia, bipolar disorder,
major depression).
The Grants for the Benefit of Homeless Individuals program was
authorized by Section 506 of the Public Health Service Act. As is true
of all other SAMHSA programs, its authorization has expired, but we
urge Congress to respond to this as it has responded for other SAMHSA
programs, by making year-to-year appropriations until the
reauthorization process can be completed. The Senate-passed bill to
reauthorize SAMHSA programs, S. 976, would reauthorize the GBHI
program.
Recommendation.--Appropriate $75 million for Projects for
Assistance in Transition from Homelessness. PATH provides formula
grants to each state for outreach, case management and treatment for
homeless people with severe mental illnesses, including those with a
dual diagnosis of mental illness and drug or alcohol addiction. PATH is
ideal for funding outreach and case management, allowing people with
severe mental illness to be brought into the system of care, their
treatment stabilized, and services to continue once they are
permanently housed.
Recommendation.--Provide $129 million for Health Care for the
Homeless (through a $1.5 billion appropriation for Consolidated Health
Centers). Health Care for the Homeless is part of the Consolidated
Health Centers line item in the budget for the Health Resource Services
Administration. The program funds clinics that specialize in the unique
treatment challenges presented by people who are homeless, often for
long periods of time. Clinics provide primary care, as well as
diagnostic, preventive, emergency medical, pharmaceutical, addiction,
and mental health services. They also conduct intensive outreach and
case management, linking patients to housing, income and
transportation. HCH projects are ideal to provide outreach and to
stabilize the worst-off homeless people.
Recommendation.--Appropriate $120 million for the Runaway and
Homeless Youth Programs. The Administration for Children and Families
within HHS operates coordinated competitive grant programs addressing
the problems of homeless and runaway youth. Runaway and Homeless Youth
programs support cost-effective, community-based services that protect
youth from the harms of life on the streets and either reunify them
safely with family or find alternative placements. RHYP ends
homelessness by engaging in outreach, and quickly rehouses as many
homeless youth as possible. For others, it provides services that will
prepare them to enter adulthood housed.
Recommendation.--Appropriate $15 million for the Homeless Veterans
Reintegration Program. The Homeless Veterans Reintegration Program,
within the Department of Labor's Veterans Employment and Training
Service, provides job placement and related services to homeless
veterans. Homeless veterans have many barriers to employment. According
to DoL, HVRP helps overcome those barriers and places veterans in jobs
at a rate of about $1430 per placement, making it extremely cost-
effective. While successful, HVRP has been able to serve only a small
portion of the homeless veteran population, due to insufficient
funding. Last year an increase for this program received bipartisan
support. This year, the Administration has requested, and we support,
the full authorization level of $15 million.
Recommendation.--Appropriate $50 million for Education for Homeless
Children and Youth. A struggle for homeless service providers who serve
families with children is to maintain the children's stability during a
time when their lives are turned upside down. Even if new housing can
be found in a short time, the lasting effects of a spell of
homelessness can be devastating, if everything in their lives is
disrupted. The most important potential source of stability for these
children is school--but only if they can continue to attend school.
That is the mission of the Education for Homeless Children and Youth
program. EHCY removes obstacles to enrollment and retention by
establishing liaisons between schools and shelters and providing
funding for transportation, tutoring, school supplies, and the
coordination of statewide efforts to remove barriers. As a result, the
percentage of homeless school age children attending school increased
from 50 percent prior to establishment of the program to 88 percent in
1997. This encourages quick rehousing of families by retaining ties to
their communities.
build the infrastructure
In addition to initiatives that focus on homelessness, bringing
homelessness to an end will require larger systemic reforms to improve
the incomes of the poorest Americans, to make housing more affordable,
and to make services widely available to those who need them. This
subcommittee's efforts in areas such as child care, education and
employment are critical in this regard. Two programs under this
subcommittee's jurisdiction are particularly important:
Recommendation.--Fully fund the Labor Department's ``Fathers Work/
Families Win'' initiative. The Department of Labor has made great
strides over the last few years in making it's programs work better for
the lowest income people, including homeless people. The proposal in
the DoL budget for the ``Fathers Work/Families Win'' initiative
provides great promise to continue the work begun by the mandatory
Welfare to Work Grants Program--making sure the poorest Americans have
the tools they need to succeed in the workplace. We urge the
subcommittee to approve that initiative while encouraging the
Department to continue to make those services, and the services of
Workforce Investment Act programs, fully available to people who are
struggling with homelessness.
Recommendation.--Appropriate $1.4 billion for the Low-Income Home
Energy Assistance Program. Inability to pay for utilities is second
only to inability to pay rent as an economic cause of homelessness.
LIHEAP has for many years proven an effective program with bipartisan
support, designed to help low-income people afford these charges and
avoid homelessness. We encourage Congress to provide adequate funding
for this important program.
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Alexander, Dr. Duane, Director, National Institute of Child
Health and Human Development, National Institutes of Health,
Department of Health and Human Services........................ 127
Prepared statement........................................... 158
American:
Academy of Physician Assistants, prepared statement.......... 375
Association of Colleges of Nursing, prepared statement....... 441
Chemical Society, prepared statement......................... 414
College of Chest Physicians, prepared statement.............. 433
Gastroenterological Association, prepared statement.......... 436
Heart Association, prepared statement........................ 396
Medical Association, prepared statement...................... 328
Museum of Natural History, prepared statement................ 537
Physiological Society, prepared statement.................... 414
Public Power Association, prepared statement................. 342
Public Transportation Association, prepared statement........ 352
Society for Microbiology, prepared statement...............393, 403
Society of Clinical Oncology, prepared statement............. 456
Society of Mechanical Engineers, prepared statement.......... 419
Society of Tropical Medicine and Hygiene, prepared statement. 475
Association of:
American Universities, prepared statement.................... 495
Population Centers, prepared statement....................... 497
Women's Health, Obstetric and Neonatal Nurses, prepared
statement.................................................. 400
Babyland Family Services, Inc., prepared statement............... 383
Battey, Dr. James F., Jr., Director, National Institute on
Deafness and Other Communication Disorders, National Institutes
of Health, Department of Health and Human Services............. 127
Prepared statement........................................... 178
Bosch, Erin, prepared statement.................................. 505
Breast Cancer Action, letter from................................ 277
Fund, letter from............................................ 275
Byrd, Hon. Robert C., U.S. Senator from West Virginia, questions
submitted by..............................................67, 80, 117
Campbell, Hon. Ben Nighthorse, U.S. Senator from Colorado,
questions submitted by......................................... 98
Cancer Leadership Council, prepared statement.................... 459
Cassman, Dr. Marvin, Director, National Institute of General
Medical Services, National Institutes of Health, Department of
Health and Human Services...................................... 127
Prepared statement........................................... 155
Children's Heart Foundation, prepared statement.................. 424
Cochran, Hon. Thad, U.S. Senator from Mississippi:
Opening statement............................................ 216
Prepared statement........................................... 217
Questions submitted by....................................... 302
Collins, Dr. Francis S., Director, National Human Genome Research
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 128
Prepared statement........................................... 192
Colonial Williamsburg Foundation, prepared statement............. 540
Condell Medical Center, prepared statement....................... 332
CORE Foundation, prepared statement.............................. 505
Council for Chemical Research, prepared statement................ 452
Cowin, Jessica, prepared statement............................... 425
Craig, Hon. Larry, U.S. Senator from Idaho, questions submitted
by............................................................. 79
Cure For Lymphoma Foundation, prepared statement................. 502
Domenici, Hon. Pete V., U.S. Senator from New Mexico, questions
submitted by................................................... 101
Doris Day Animal League, prepared statement...................... 428
Elmira College, Elmira, NY, prepared statement................... 510
Epilepsy Foundation, prepared statement.......................... 388
Facioscapulohumeral Society, Inc., prepared statement............ 488
Fauci, Dr. Anthony S., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services........................ 127
Prepared statement........................................... 152
FDA-NIH Council, prepared statement.............................. 471
Federation of:
American Societies for Experimental Biology, prepared
statement.................................................. 430
Behavioral, Psychological and Cognitive Sciences, prepared
statement.................................................. 514
Feinstein, Hon. Dianne, U.S. Senator from California:
Prepared statements.........................................45, 217
Questions submitted by......................................87, 120
Fight Crime: Invest in Kids, prepared statement.................. 522
Fischbach, Dr. Gerald D., Director, National Institute of
Neurological Disorders and Stroke, National Institutes of
Health, Department of Health and Human Services................ 127
Prepared statement........................................... 149
Florida State University, prepared statement..................... 520
Gordis, Dr. Enoch, Director, National Institute on Alcohol Abuse
and Alcoholism, National Institutes of Health, Department of
Health and Human Services...................................... 128
Prepared statement........................................... 186
Gorton, Hon. Slade, U.S. Senator from Washington, prepared
statement...................................................... 65
Grady, Dr. Patricia A., Director, National Institute of Nursing
Research, National Institutes of Health, Department of Health
and Human Services............................................. 128
Prepared statement........................................... 189
Harkin, Hon. Tom, U.S. Senator from Iowa:
Opening statements...........................................3, 213
Prepared statements..........................................4, 214
Questions submitted by....................................... 305
Herman, Hon. Alexis M., Secretary, Office of the Secretary,
Department of Labor............................................ 1
Prepared statement........................................... 7
Summary statement............................................ 4
Hodes, Dr. Richard J., Director, National Institute on Aging,
National Institutes of Health, Department of Health and Human
Services....................................................... 127
Prepared statement........................................... 167
Hollings, Hon. Ernest F., U.S. Senator from South Carolina,
questions submitted by......................................... 76
Hrynkow, Dr. Sharon, Ph.D., Acting Associate Director for Program
Coordination, Fogarty International Center, National Institutes
of Health, Department of Health and Human Services............. 128
Humane Society, prepared statement............................... 444
Hutchison, Hon. Kay Bailey, U.S. Senator from Texas, questions
submitted by.............................................66, 105, 112
Hyman, Dr. Steven E., Director, National Institute of Mental
Health, National Institutes of Health, Department of Health and
Human Services................................................. 128
Prepared statement........................................... 180
Idaho State University, prepared statement....................... 381
Inouye, Hon. Daniel K., U.S. Senator from Hawaii, question
submitted by................................................... 77
International Brain Injury Association, prepared statement....... 385
Joslin Diabetes Center, prepared statement....................... 453
Katz, Dr. Stephen I., Director, National Institute of Arthritis
and Musculoskeletal and Skin Diseases, National Institutes of
Health, Department of Health and Human Services................ 127
Prepared statement........................................... 175
Kennedy Krieger Institute, prepared statement.................... 482
Keusch, Dr. Gerald T., Director, Fogarty International Center,
prepared statement............................................. 202
Kirschstein, Dr. Ruth L., Acting Director, National Institutes of
Health, Department of Health and Human Services................ 127
Prepared statement........................................... 130
Summary statement............................................ 129
Klausner, Dr. Richard D., Director, National Cancer Institute,
National Institutes of Health, Department of Health and Human
Services....................................................... 127
Letter from.................................................. 279
Prepared statement........................................... 136
Kohl, Hon. Herb, U.S. Senator from Wisconsin:
Prepared statement........................................... 242
Questions submitted...............................69, 105, 114, 314
Kupfer, Dr. Carl, Director, National Eye Institute, National
Institutes of Health, Department of Health and Human Services.. 127
Prepared statement........................................... 161
Lenfant, Dr. Claude Director, National Heart, Lung, and Blood
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 127
Prepared statement........................................... 140
Leshner, Dr. Alan I., Director, National Institute on Drug Abuse,
prepared statement............................................. 183
Lindberg, Dr. Donald A.B., Director, National Library of
Medicine, National Institutes of Health, Department of Health
and Human Services............................................. 128
Prepared statement........................................... 205
Lovelace Respiratory Research Institute, prepared statement...... 454
Lymphoma Research Foundation, prepared statement................. 460
Maddox, Dr. Yvonne T., Acting Director, National Institutes of
Health, Department of Health and Human Services................ 127
Prepared statement........................................... 133
Malz, Rachel, Madison, WI, prepared statement.................... 243
Marin Breast Cancer Watch, letter from........................... 274
Mended Hearts, Inc., prepared statement.......................... 504
Mikulski, Hon. Barbara A., U.S. Senator from Maryland, questions
submitted by................................................... 321
Millstein, Richard, Deputy Director, National Institute on Drug
Abuse, National Institutes of Health, Department of Health and
Human Services................................................. 128
Montefiore Medical Center, prepared statement.................... 337
Murray, Hon. Patty, U.S. Senator from Washington:
Opening statement............................................ 53
Questions submitted by..................................71, 77, 115
Nathanson, Dr. Neal, Director, Office of AIDS Research, National
Institutes of Health, Department of Health and Human Services.. 128
Prepared statement........................................... 208
National:
Alliance for Eye and Vision Research, prepared statement..... 473
For the Mentally Ill, prepared statement................. 347
To End Homelessness, prepared statement...................... 547
Association for State Community Services Programs, prepared
state-
ment....................................................... 372
Of Foster Grandparent Program, prepared statement........ 534
Center for Learning Disabilities, prepared statement......... 450
Coalition for Cancer Research, prepared statement............ 421
Congress of American Indians, prepared statement............. 545
Consumer Law Center, prepared statement...................... 345
Council on Independent Living, prepared statement............ 356
Depressive and Manic-Depressive Association, prepared
statement.................................................. 438
Federation of Community Broadcasters, prepared statement..... 533
Indian Impacted Schools Association, prepared statement...... 528
Jewish Medical and Research Center, prepared statement....... 378
Military Family Association, prepared statement.............. 525
Minority Public Broadcasting Consortia, prepared statement... 542
Multiple Sclerosis Society, prepared statement............... 415
Nutritional Foods Association, prepared statement............ 463
Prostate Cancer Coalition, prepared statement................ 457
Sleep Foundation, prepared statement......................... 448
Treasury Employees Union, prepared statement................. 335
New York University, prepared statement.......................... 368
New York-Presbyterian Hospital, prepared statement............... 417
Newark, NJ, city of, prepared statement.......................... 362
Northwest Regional Educational Laboratory, prepared statement.... 513
NYU School of Medicine, prepared statement....................... 466
Olden, Dr. Kenneth, Director, National Institute of Environmental
Health Sciences, National Institutes of Health, Department of
Health and Human Services...................................... 127
Prepared statement........................................... 164
Parkinson's Action Network, prepared statement................... 500
Persons United Limiting SubStandards & Errors in Healthcare of
Colorado, prepared statement................................... 325
Pinon Community School Board, Inc., prepared statement........... 508
Piwowar, Andrea, prepared statement.............................. 425
Population Association of America, prepared statement............ 497
Riley, Hon. Richard W., Secretary, Office of the Secretary,
Department of Education........................................ 30
Prepared statement........................................... 33
Roberts, Denise, board member, PULSE of Colorado, prepared
statement...................................................... 343
Rotary International, prepared statement......................... 390
Santa:
Marta Hospital, prepared statement........................... 408
Rosa Memorial Hospital, prepared statement................... 330
Scleroderma Research Foundation, prepared statement.............. 493
Shalala, Hon. Donna, Secretary, Office of the Secretary,
Department of Health and Human Services........................ 15
Prepared statement........................................... 18
Slavkin, Dr. Harold, Director, National Institute of Dental and
Craniofacial Research, National Institutes of Health,
Department of Health and Human Services........................ 127
Prepared statement........................................... 143
Society for Animal Protective Legislation, prepared statement.... 485
Society of Toxicology, prepared statement........................ 477
Specter, Hon. Arlen, U.S. Senator from Pennsylvania:
Opening statements...........................................1, 128
Questions submitted by.................................73, 106, 284
Spiegel, Dr. Allen M., Director, National Institute of Diabetes
and Digestive and Kidney Diseases, National Institutes of
Health, Department of Health and Human Services................ 127
Prepared statement........................................... 146
St. Joseph's Hospital Health Center, prepared statement.......... 340
Stevens, Hon. Ted, U.S. Senator from Alaska:
Opening statements..........................................37, 247
Prepared statement........................................... 39
Stokes, Louis, former Congressman, prepared statement............ 480
Straus, Dr. Stephen E., Director, National Center for
Complementary and Alternative Medicine, National Institutes of
Health, Department of Health and Human Services................ 128
Prepared statement........................................... 198
Taylor, Teresa, prepared statement............................... 427
Texas:
Neurofibromatosis Foundation, prepared statement............. 467
Tech University Health Sciences Center, prepared statement... 406
United:
Negro College Fund, prepared statement....................... 518
Stribes Technical College, prepared statement................ 530
University of:
Medicine and Dentistry of New Jersey, prepared statement..... 365
Miami School and the Lovelace Respiratory Research Institute,
prepared statement......................................... 371
Michigan, prepared statement................................. 411
Tulsa, prepared statement.................................... 521
Vaitukaitis, Dr. Judith L., Director, National Center for
Research Resources, National Institutes of Health, Department
of Health and Human Services................................... 128
Prepared statement........................................... 196
Van Pelt, Megan, prepared statement.............................. 426
Wake Forest University Baptist Medical Center, prepared statement 469
Williams, Dennis P., Deputy Assistant Secretary, Budget, National
Institutes of Health, Department of Health and Human Services.. 128
SUBJECT INDEX
----------
DEPARTMENT OF EDUCATION
Office of the Secretary
Accountability, increased........................................ 34
Additional committee questions................................... 66
Basics, mastering the............................................ 35
Budget:
Request...................................................... 31
Balance with resources................................... 39
CDC's buildings and facilities................................... 44
Class size:
School violence.............................................. 54
Reduction.................................................... 106
Funding.................................................. 53
Program--teachers hired.................................. 115
Use of program funds..................................... 54
Clinical trials data base........................................ 45
College:
Making more affordable....................................... 37
New pathways to.............................................. 36
Opportunities tax cut........................................ 33
Community learning centers, 21st century......................... 32
Delta:
Regional authority........................................... 63
Rural health centers in the.................................. 64
Education........................................................ 46
Federal share of costs....................................... 108
Good news about.............................................. 31
Incarcerated youth........................................... 110
Immigrant funds.............................................. 122
Importance of technology in.................................. 38
Long-distance................................................ 39
Merit-based student financial assistance..................... 117
Needs-based.............................................. 117
Recognizing higher institutions with effective reduction in
impact aid................................................. 122
State of American............................................ 30
Tax incentives............................................... 117
Head Start...................................................49, 72, 87
Cognitive skills in early childhood, focus on................ 51
Standards in............................................. 50
Customer satisfaction in..................................... 50
HHS and ED coordination on..................................52, 124
Program...................................................... 123
Staff salaries..............................................53, 125
Teaching of cognitive skills................................. 124
Transferred from HHS to ED?.................................. 50
Heavily impacted districts, payments for......................... 123
Impact aid funding and the administration's construction proposal 113
OIG report....................................................... 60
Pell Grant maximum award......................................... 33
Pensions paid via lump sum vs. annuity........................... 43
Professional development programs and early intervention address
the achievement gap............................................ 109
Programs:
Alcohol and drug prevention.................................. 120
Byrd Scholarship............................................. 117
Children's health insurance.................................. 32
Civilian-based ``troops-to-teachers''........................ 112
Flexibility in reduction...................................107, 122
Flexibility of block grants over targeted.................... 114
Implementation of Teacher Recruitment and professional
development................................................ 110
Low Income Home Energy Assistance (LIHEAP)................... 73
Role of Federal Education.................................... 54
Voluntary single-sex school and classroom.................... 112
Safe:
Drug-free schools and communities............................ 32
Schools/healthy students initiative.......................... 32
Schools:
Construction...............................................107, 118
Districts, meeting diverse needs of.......................... 42
Improving low-performing..................................... 34
Modernization................................................33, 35
Safety and discipline........................................ 32
Small, safe and successful high schools initiative........... 32
Turning around failing....................................... 114
Student:
Financial assistance, rewarding excellence in................ 118
Debt--growing imbalance of student education loans to grants
in paying for college...................................... 116
Teachers:
Certification--National Board for professional teaching
standards.................................................. 118
Improving quality............................................ 36
12-month working year for.................................... 111
Recruitment and professional development programs............ 109
Recruitment and retention.................................... 31
Shortages and the budget proposal............................ 119
Technology literacy challenge fund programs and preparing
tomorrow's teachers to use technology.......................... 115
Training programs as a percentage of all Federal training.... 109
Title I:
Hold harmless................................................ 120
Reauthorization proposal to increase accountability.......... 121
Strengthening accountability provisions to increase academic
achievement................................................ 121
Youth violence:
Mass media entertainment and................................. 42
Prevention................................................... 111
Washington Post, quote from the.................................. 57
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Acquired immune deficiency syndrome (AIDS)....................... 153
Vaccine development.......................................... 239
Additional committee questions................................... 73
Adolescent alcohol use........................................... 189
Outreach..................................................... 189
Prevention and treatment, advances in........................ 188
Adulthood........................................................ 180
Advocates on comittees........................................... 309
Aging, biology of................................................ 168
Research...................................................167, 241
America:
Creating a healthier......................................... 26
Road map to a better......................................... 29
Appropriations language, reports requested in last year's........ 92
Battered women and children...................................... 77
Basic services................................................... 207
Bedside application, bench to.................................... 219
Behavioral research.............................................. 160
BIDIS............................................................ 90
Bioterrorism..................................................... 41
Bioengineering, computers, and advanced instrumentation.......... 197
Budget:
1997 emergency supplemental.................................. 275
Increases.................................................... 273
Indian Health Service........................................ 100
Institute/centers............................................ 246
NHLBI........................................................ 244
NIDCR'S...................................................... 245
NIND'S....................................................... 245
President's................................................143, 211
Building:
Nursing research capacity.................................... 192
On recent accomplishments.................................... 184
Cancer:
Burden of.................................................... 136
Challenges................................................... 218
Chronology of Freedom of Information Act (FOIA) request
regarding $15 million emergency appropriation for breast
and environmental factors research......................... 276
Environmental risk factors................................... 94
Imaging...................................................... 138
Quality care--a research agenda.............................. 139
Registries................................................... 94
State of care................................................ 220
Career development............................................... 198
CDC, fiscal management at........................................ 29
Chapter 6........................................................ 281
Child care.......................................................47, 78
Children and depression.......................................... 297
Chromosome 22.................................................... 193
Clinical research..............................................175, 191
Networks..................................................... 141
Trials--A Cornerstone of Progress for Patients............... 139
Data base................................................ 93
Complementary and alternative medicine........................... 250
Funding for.................................................. 250
Conference Report 105-119........................................ 281
Co-occurring disorders........................................... 309
Dental and craniofacial diseases and disorders, burden of........ 143
Detection and diagnosis, new approaches to....................... 137
Development...................................................... 178
Diabetes..................................................102, 317, 304
Juvenile..................................................... 242
Discovering solutions to complex problems........................ 143
Diseases:
Alzheimer.................................................... 315
Autoimmune.................................................176, 311
Brain, working together to fight............................. 151
Chronic--a long-range view about long-term illness........... 190
Duchenne Muscular Dystrophy.................................. 316
Emerging infectious, novel approaches to treatment and
control of................................................. 203
Epilepsy...................................................241, 314
Fibromyalgia................................................. 176
Hantavirus................................................... 99
Immune-mediated.............................................. 154
Multiple Myeloma............................................. 319
Muscle....................................................... 176
Muscular Dystrophy........................................... 301
Neurodegeneration, halting the process of.................... 150
Neurofibromatosis............................................ 142
Neuroscience................................................. 187
Osteoarthritis............................................... 176
Osteogenesis Imperfecta...................................... 299
Osteoporosis..........................................176, 299, 300
Consensus conference on.................................. 298
Screening and treating................................... 299
Skin......................................................... 177
Parkinson's.................................................. 304
Research, benefits to other.................................. 210
Schizophrenia................................................ 308
Systemic, oral infection linked to........................... 145
Drugs of abuse, long-term neurobehavioral effects of............. 184
Drug use preferences and patterns, determinants of............... 184
Drug user to addict, understanding the transition from........... 185
Emerging epidemics of noncommunicable disease: Fiscal year 2001
initiatives, taking steps to address........................... 204
End of life--an emerging research focus.......................... 191
Environmental factors............................................ 275
Expanded health care coverage.................................... 19
Exposure assessment.............................................. 166
Fiscal year 2000 increase, uses of............................... 149
Fly Genome, finishing the........................................ 194
Fogarty International Center...................................258, 271
Future:
Direction of vision research................................. 163
Research plans............................................... 148
Scientific plans and projects................................ 201
Gene:
Discoveries: the rapid rate of progress...................... 144
Inflammation and tooth loss.................................. 145
Sequencing................................................... 248
Genetics......................................................... 187
Information, safeguarding the fair use of.................... 195
Medicine...................................................197, 207
Tooth agenesis............................................... 145
Global health.................................................... 152
Government Performance and Results Act....................143, 186, 192
Grants review process............................................ 286
Health:
Access for the uninsured..................................... 74
Care......................................................... 47
Centers waivers.............................................. 77
Disparities, addressing...............................142, 155, 185
Disparities......................................159, 177, 198, 206
Closing the gap.......................................... 191
Information for the public................................... 205
Initiative................................................... 134
Status of American Indians................................... 98
HIV/AIDS......................................................... 89
Developing cost-effective methods of preventing.............. 202
Research..................................................... 160
Healthy brain for life........................................... 150
Heart attack, using MRI to diagnose.............................. 141
HHS youth violence prevention activities......................... 23
Human:
DNA sequencing............................................... 193
Genetic Variation............................................ 193
Genome................................................238, 295, 296
Tools for understanding the.............................. 195
Sequence, beyond the......................................... 193
Subject protection........................................... 309
Immunizations.................................................... 89
Individual patient, focus on the................................. 142
Injectable drugs and biologics, coverage of...................... 76
Indian health:
Research...................................................100, 101
Service funding.............................................. 92
Infancy and childhood............................................ 178
Infectious:
Disease...................................................... 302
Diseases: Challenges and opportunities....................... 152
Information dissemination........................................ 201
Liver allocation policies........................................ 76
Low Vision....................................................... 161
Magnetic therapy................................................. 302
Major Initiatives................................................ 156
Medical:
Errors....................................................... 75
Informatics.................................................. 206
Medicare:
Osteoporosis................................................. 300
Reimbursement of ambulance services.......................... 87
Mental:
Health research.............................................. 305
Illness, heightened public awareness of...................... 181
Retardation.................................................. 158
Methamphetamine.................................................. 249
Minority representation.......................................... 321
Molecular Targets--New Approaches to Prevention & Treatment...... 138
Mouse genome..................................................... 296
Multi-modal treatment assessment of ADHD......................... 183
National:
Aging Institute.............................................. 225
Cancer Institute.................................221, 250, 259, 290
Budget................................................... 243
Extramural research on breast cancer and proud history... 18
Library of Medicine.......................................... 272
Center for:
Complementary and Alternative Medicine................... 269
Research Resources.....................................227, 270
Eye Institute.........................................224, 254, 264
Heart, Lung, and Blood Institute......................222, 251, 260
Human Genome Research Institute............................227, 271
Institute of:
Allergy and Infectious Diseases...................223, 253, 262
Arthritis and Musculoskeletal and Skin Diseases...226, 255, 266
Child Health and Human Development................224, 254, 264
Dental and Craniofacial Research..................222, 252, 261
Diabetes and Digestive and Kidney Diseases........222, 252, 261
Environmental Health Sciences.....................225, 254, 265
General Medical Sciences...............................224, 263
Health/Department of Energy Partnership.................. 101
Mental Health.....................................226, 256, 267
Research agenda...................................... 307
Neurological Disorders and Stroke............223, 252, 262, 298
Nursing Research..................................227, 257, 270
Institute on:
Aging..................................................255, 266
Alcohol Abuse and Alcoholism...........................227, 269
Deafness and other Communication Disorders........226, 256, 257
Drug abuse........................................227, 257, 268
Nervous system, repairing the injured............................ 150
New clinical effectiveness trials................................ 182
New investment, areas of......................................... 180
NIH............................................................102, 103
Buildings and facilities..................................... 289
Doubling: Future implications................................ 284
OEO, workplace environment of................................ 321
Salary cap................................................... 91
OD activities.................................................... 135
Office of:
Behavioral and Social Sciences Research...................... 134
Disease Prevention........................................... 134
Research on Women's Health................................... 135
Past and future accomplishments.................................. 259
Pediatric trauma rehabilitation.................................. 160
Possible accomplishments......................................... 245
Powerful research tools.......................................... 146
Priority:
Better therapies............................................. 209
Health disparities in the United States...................... 209
HIV prevention............................................... 210
International research....................................... 209
Vaccines.....................................................
Programs:
Family Caregiver............................................. 74
Genomic Analysis............................................. 140
Gene Therapy, of excellence in............................... 141
Performance, rigorously evaluating........................... 28
Promise of Pathogen Genomics..................................... 153
Public Health and Social Services Emergency Fund................. 281
Public Law 105-18................................................ 281
Reducing:
Disease and disability....................................... 169
Health disparities.........................................151, 169
Renewed support for children and families........................ 22
Reports, status of............................................... 80
Research:
Advances: PKD, Hepatitis C, and diabetes..................... 146
Bringing about shifts in national strategy................... 185
Capacity..................................................... 198
Children's mental health disorders........................... 306
Dissemination efforts, rapid and authoritative............... 186
Grants....................................................... 211
Health disparities........................................... 183
Minority mental health....................................... 306
Progress in basic............................................ 137
Studies, current............................................. 200
Youth violence............................................... 182
Rural aging, international conference on......................... 85
Scientific advancement, greater.................................. 25
Sequencing:
Of the human genome.......................................... 296
The laboratory mouse......................................... 194
Snapshot of the cell's protein factory........................... 155
State Children's Health Insurance Program (SCHIP) enrollment..... 91
Stem cells....................................................... 286
Diabetes...................................................215, 235
Research...................................................214, 221
And diabetes............................................. 65
Study of:
Adverse health effects of air pollutants, particulate matter
and ozone.................................................. 283
Gene-environment interaction in the etiology of breast
cancer, in high-risk areas of the United States............ 282
Susceptibility to environmental toxicants........................ 165
Systemic Lupus Erythematosus..................................... 177
Technologies, high throughput.................................... 165
Thirty years of accomplishment................................... 161
Toxicology....................................................... 188
Translational:
Research..................................................... 162
Science, centers for......................................... 181
Treatment:
Dually diagnosed individuals, options for.................... 310
Juvenile diabetes............................................ 234
Research on Autism........................................... 182
United States, evolving epidemic in the.......................... 208
Unrelenting Pandemic............................................. 208
Vaccine development.............................................. 153
Visual health disparities........................................ 162
Vulnerability genes for mental disorders, identifying............ 182
Welfare recipients, training and................................. 54
West Virginia, obesity in........................................ 86
Worker health.................................................... 73
Youth:
Prevention of violence....................................... 42
Violence...............................................75, 229, 230
Safety and health............................................ 65
DEPARTMENT OF LABOR
Office of the Secretary
Bonus Incentive Act.............................................. 66
Convention 176................................................... 68
Homeless veterans programs....................................... 11
Job training highlights of the 2001 request.................. 71
National Mine Safety and Health Academy.......................... 67
Pay equity....................................................... 72
Quality workplaces............................................... 12
Strategic goals.................................................. 8
Transportation funding for welfare workers....................... 41
Traveling sales crew industry.................................... 70
Workforce:
Prepared..................................................... 8
Secure....................................................... 11
Worker Adjustment and Retraining Notification Act................ 69
Workforce Investment Act impact.................................. 70
Working families, helping at a time of unprecedented prosperity.. 7
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