[Senate Hearing 107-404]
[From the U.S. Government Publishing Office]
S. Hrg. 107-404, Pt. 1
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
on
H.R. 3061/S. 1536
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, 2002, AND FOR OTHER PURPOSES
__________
Part 1 (Pages 1-572)
Department of Education
Department of Health and Human Services
Department of Labor
Nondepartmental witnesses
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Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/
congress/senate
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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
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
MARY L. LANDRIEU, Louisiana
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
Terrence E. Sauvain, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire ERNEST F. HOLLINGS, South Carolina
LARRY E. CRAIG, Idaho DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas HARRY REID, Nevada
TED STEVENS, Alaska HERB KOHL, Wisconsin
MIKE DeWINE, Ohio PATTY MURRAY, Washington
MARY L. LANDRIEU, Louisiana
ROBERT C. BYRD, West Virginia
(Ex officio)
Professional Staff
Bettilou Taylor
Mary Dietrich
Jim Sourwine
Mark Laisch
Ellen Murray (Minority)
Adrienne Hallett (Minority)
Erik Fatemi (Minority)
Administrative Support
Correy Diviney
Carole Geagley (Minority)
C O N T E N T S
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Tuesday, March 6, 2001
Page
Work Safety and the Ergonomics Rule.............................. 1
Wednesday, April 25, 2001
Department of Health and Human Services: Office of the Secretary. 27
Thursday, April 26, 2001
Ergonomics....................................................... 65
Wednesday, May 2, 2001
Department of Labor: Office of the Secretary..................... 201
Thursday, May 10, 2001
Department of Education: Office of the Secretary................. 251
Wednesday, May 23, 2001
Department of Health and Human Services: Office of the Secretary. 293
Nondepartmental Witnesses
Department of Education.......................................... 417
Department of Health and Human Services.......................... 448
Related agencies/general testimony............................... 684
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002
----------
TUESDAY, MARCH 6, 2001
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:39 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senator Specter.
WORK SAFETY AND THE ERGONOMICS RULE
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health and Human
Services, and Education will now proceed.
The hearing on ergonomics has been convened on very short
notice, as we have not had much notice that the issue would be
on the Senate floor, which it is today, and I thought it would
be useful to hear from parties in the field, the
representatives of the factions which are in opposition to the
current ergonomics regulation, representatives in favor of the
regulation, and from the Associate Solicitor of Labor for OSHA,
the Agency which had the responsibility for promulgating the
regulation.
I had a brief informal meeting with the parties in my
office. We will proceed now to try to address a number of the
critical issues. I would start with the question as to the
views of the witnesses, and I welcome Mr. Joseph M. Woodward,
Esq., who is Associate Solicitor of Labor for OSHA, and Baruch
Fellner, Esq., a partner at Gibson, Dunn & Crutcher, practicing
employment law with emphasis on occupational safety and health,
and Lynn Rhinehart, Esq., associate counsel of the AFL-CIO. We
will start with the baseline question as to whether there ought
to be any regulation at all. Mr. Fellner, let me start with you
on that first.
STATEMENT OF BARUCH A. FELLNER, ESQ., PARTNER, GIBSON,
DUNN & CRUTCHER, LLP
Mr. Fellner. Based upon the science, the law, and medicine
as we presently know it, the regulation which OSHA has
promulgated is beyond the mark and is fatally flawed.
Whether there should be any regulation of ergonomics will
and should depend on the proper nonrush to judgment evaluation
of this extraordinarily complex area, and Secretary Chao in her
confirmation hearings has emphasized precisely that, and that
is, these are issues which are inordinately complicated, both
from an economic as well as a scientific and medical
perspective, and given that, given the time frame that it took
between proposal to final in this instance, a time frame which
the head of the OSHA effort, Marthe Kent, referred to as a
miracle if OSHA could promulgate this standard in time--and by
in time, we all know that that meant before the close of the
last administration.
Senator Specter. Then you are essentially saying there
could be a regulation, but it has to be properly formulated.
What would you recommend as the course to formulate such a
regulation?
Mr. Fellner. We would recommend what we recommended to OSHA
during the course of the hearings, and it was a recommendation
that was echoed by the Chief Administrative Judge, Judge
Vittone, and that was, first, given the complexity of the
issues involved, the medical and scientific issues, it would be
appropriate, it would be absolutely necessary to get into the
same room the major medical and scientific minds on both sides
and let them have, over a period of 2 or 3 days, or however
long it took, with appropriate overview from the Department of
Labor, a full and free discussion of what the science shows.
Senator Specter. Who should those people be?
Mr. Fellner. We represent the National Coalition on
Ergonomics and a number of other petitioners in the lawsuit
against this litigation, or against this regulation. As part of
that lawsuit, we submitted statements from 21 of the world's
greatest experts, amongst whom is Alf Nachemson. Alf Nachemson
from Sweden, is viewed as the greatest authority on low back
pain, period, full stop. He has submitted a statement into the
OSHA record indicating that this standard is so ill-advised
from an economic, a medical and a scientific perspective, that
it should not be promulgated. Alf Nachemson, N-a-c-h-e-m-s-o-n,
and there are many others.
Senator Specter. How many such experts would you recommend
representing your side of the issue?
Mr. Fellner. I would suggest, Senator Specter, that it
might be slightly premature to get into those specifics, but at
least a half-a-dozen, half-a-dozen to a dozen experts from our
side I would suggest, respectfully, from the appropriate
medical side, and I would also remind the chairman that two
august medical bodies, the American College of Occupational and
Environmental Medicine, representing over 100,000 occupational
doctors, supporters of ergonomic principles from day 1, have
written a specific letter opposing this final standard. They
should be represented. Two, the American Academy of Orthopedic
Surgeons submitted a comment into the record opposing this
proposed regulation. They should be represented, and if the
other side wants to bring in their ergonomists to represent
their position insofar as what the medical and scientific
issues reflect, by all means let them do so, but if I might
add, when we made that suggestion of a full and free discussion
with regard to these issues, OSHA declined, and declined in
writing. That issue has to be redressed.
STATEMENT OF LYNN RHINEHART, AMERICAN FEDERATION OF
LABOR-CONGRESS OF INDUSTRIAL ORGANIZATIONS
Senator Specter. Before taking up, Mr. Fellner, with your
specific objections to the regulation, let me ask Ms. Rhinehart
what her view is of such an interchange among experts.
Ms. Rhinehart. Well, Senator, I think that is a fine idea,
but in fact it has already happened. It has already happened a
number of times, the most recently the National Academy of
Sciences recently issued a comprehensive report, and that was
ordered by Congress as part of the appropriations process 2
years ago.
The NAS issued a comprehensive report after reviewing all
of the literature on ergonomics, and this was a gathering of
major scientific minds. As Mr. Fellner put it, this was a
gathering of major scientific minds, the National Academy of
Sciences, and they came out with a comprehensive report in
January that found not only is there a strong association
between worker exposure to ergonomic risk factors in the
workplace, and development of ergonomic injuries, but also that
interventions reducing those exposures was effective at
reducing worker injuries.
Senator Specter. Did the National Academy of Sciences
support this regulation?
Ms. Rhinehart. The NAS, their job was to look at the
science and to make conclusions about what the science says at
this point. They were very explicit that they were not making
policy recommendations, that their job was to look at science,
not policy, so they did not take a specific position on the
ergonomics regulation. However, their findings clearly support
an ergonomics regulation. They found that, as I said----
Senator Specter. Well, they clearly support regulation, but
the focused question is whether they support this regulation.
Ms. Rhinehart. They were not asked to support this
regulation, so they did not comment on this regulation.
Senator Specter. They were not asked to comment about this
regulation?
Ms. Rhinehart. Correct. They were asked to look at the
science, and they did, and they found the science supports
ergonomic interventions.
STATEMENT OF JOSEPH M. WOODWARD, ASSOCIATE SOLICITOR OF
LABOR, OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION, DEPARTMENT OF LABOR
Senator Specter. Mr. Woodward, is it true, as Mr. Fellner
says, that OSHA specifically rejected a convocation of experts
on both sides?
Mr. Woodward. I believe he is referring to a letter that
was written during the course of the rulemaking proceedings for
this standard. In order to promulgate a standard, we have to
follow certain procedures, which include public hearings and an
opportunity for comment. We were engaged in following those
proceedings at that time, which are all on the record and
subject to certain requirements, so I believe it is correct
that at that time we did not take up that opportunity.
If I could make a few other points, first of all, I am here
in a technical capacity to try to help describe the rule and
the issues in the rule. I am not here to advocate a particular
policy solution here.
Senator Specter. Well, are you here to advocate the rule?
Mr. Woodward. I would like to note that the Agency has
finalized a rulemaking, and that it found on the record that
the criteria for issuing an OSHA standard, in the agency's
view, as of last November, were satisfied. Those criteria are:
is there a significant risk of harm; is the harm material; and
is there a feasible way to reduce the harm. That was the
finding that was made in November.
Any approach to ergonomics, if it is in a regulatory
approach, would have to follow the criteria that Congress has
laid down, and also the procedures. Since we issued the rule, a
number of people have filed lawsuits. Thirty-one lawsuits have
been filed. A lot of objections have been raised to the rule.
The Secretary has said that these are very complicated issues
that she wants to study carefully. We are aware of the fact
that many people have objected to the provisions of the rule.
Senator Specter. Well, you give the reasons why you
rejected the idea of having experts on both sides come in,
because, as you describe it, you are in the middle of a
rulemaking process. Do you think that Mr. Fellner's suggestion
is a good one, if you are going back to the start again?
Mr. Woodward. We always think it is a good idea to meet
with different people who have different viewpoints, and hear
what they have to say, because certainly you can learn
something that way.
Senator Specter. Is that a yes answer?
Mr. Woodward. Yes. A meeting or a discussion is a good
thing. If the idea is to do a rulemaking, eventually you have
to go through the procedures I mentioned, and you have to make
your decision on the basis of the evidence.
Senator Specter. Do those procedures allow at some stage to
have the expertise that Mr. Fellner described convened and
discuss the matter?
Mr. Woodward. Certainly. There are public hearings where
people can come in and say what they want and question each
other.
Senator Specter. I do not think he is talking about a
public hearing, although it could be open to the public. Well,
you can call it a public hearing.
Mr. Fellner, coming to the substance of this regulation,
what, in your view, is wrong with it?
Mr. Fellner. If I may be given a couple of minutes to
address that, Senator Specter, rather than a relatively brief
period of time.
Senator Specter. Take whatever time you need, Mr. Fellner.
Mr. Fellner. I appreciate it immensely. It is important to
reflect, obviously, the perspective from which I come. I am an
attorney. I represent the National Coalition on Ergonomics, and
some 106 out of 136 petitioners in this matter and, in the
interest of an open record, it is important to recognize that I
am an attorney reflecting those clients.
Having said that, and if you would allow me a personal
digression, I have been practicing occupational safety and
health law for 30 years. In my formative years as a lawyer I
was in charge of OSHA enforcement for a period of approximately
10 years, and it is with a great deal of sadness and mixed
emotion that I am here today, speaking against a regulation
from an agency for which I have enormous respect and an agency
which I believe has a very, very important task in this
country. It has gone too far insofar as this particular
regulation is concerned.
And let me emphasize, Senator Specter, what we are not
opposed to. We are not opposed to the voluntary application of
ergonomic principles in the workplace. Ever since the wheel was
invented, man has understood that it is preferable to use a
wheelbarrow to move rocks than it is to do it on his back. That
is pure, sensible, logical, you want to make the job as
comfortable----
Senator Specter. Mr. Fellner, it does not advance the issue
much to say that you are in favor of voluntary compliance. Of
course, if it is voluntary, who would have any objection to
that. The issue moves from that as to whether you need
something more.
Mr. Fellner. That is right, and the question is whether
this--not whether you need, with all due respect, whether you
need something more, in the context of your first question to
me, any regulation. The issue before us this morning, with
respect, is this midnight regulation that we are talking about.
Senator Specter. Precisely. That is why I am asking you
what is wrong with it, in your view.
Mr. Fellner. It is the most intrusive, most far-reaching
micromanagement of American industry in the history of the
Department of Labor. It is, to put it bluntly, bad law, bad
economics, bad science, and bad medicine, and if I could touch
on all of those four briefly this morning, I can give what I
would think would be a complete response.
Senator Specter. That is fine. To the extent you can be
specific as to what there is in the regulation which is costly,
which is inefficient, and which does not move to protect worker
safety, we would appreciate it.
Mr. Fellner. Thank you. The final standard we are talking
about, Senator Specter, does a 180 from the proposal. The
proposal as a result of 2\1/2\ months of hearings in which I
participated, cross-examined OSHA's witnesses. That proposal, I
dare say the agency concluded was vague to the point of being
unconstitutional and, instead of going with the proposal, they
went with a final standard which was not the logical outgrowth,
could not be anticipated from that which was proposed, and let
me give you one or two examples, if I may.
The final standard contains nine mathematical formulas
which include basic screening tools and hazard identification
tools to tell the employer how to act, how to lift, what to
move, what constitutes repetition. The final standard defines
repetition as two motions performed within 1 minute over a 2-
hour period of time. One minute is interminable. I would
challenge----
Senator Specter. Two motions?
Mr. Fellner. Within 1 minute, which are repetitive. A
repetitive cycle is two motions within 1 minute over 2 hours.
We do not have the time this morning to take out a stop-
watch, and if you take out a stop-watch and determine how slow
1 minute is, and how few two motions are, that is the stately
pace that OSHA would want American business to function at.
Senator Specter. I would like to have Ms. Rhinehart's
comment. We will come right back to you.
Ms. Rhinehart. Thank you, Senator. I hesitate to guess
exactly what Mr. Fellner is talking about, but I believe he is
talking about the triggers that OSHA included in its final
rule, triggers which simply tell an employer, hey, your worker
may be exposed to a hazard here, and you need to do a job
analysis, fully analyze the job, and see if your worker is
exposed to a hazard.
Nowhere in this rule does it say that workers, or that
employers have to restrict workers to doing a motion less than
two times a minute. That simply does not appear anywhere in
this rule.
Senator Specter. Mr. Fellner.
Mr. Fellner. Yes. I would like to read page 68848 of the
Federal Register document.
Senator Specter. We will include that page in the record at
this point.
[The information follows:]
Mr. Fellner. This is table W-1, which is the basic
screening tool. The left-hand column reads, ``risk factors this
standard covers.'' The first one is repetition. In that first
definition it says, repeating the same motions every few
seconds, or repeating a cycle of motions involving the affected
body part more than twice a minute for more than 2 consecutive
hours in a work day. That is OSHA's definition of what it calls
a risk factor this standard covers, which is repetition.
We always wanted during the course of this hearing for OSHA
to tell us how much is too much. They have, in their own words.
This is their definition of repetition, and while we are on
this page, Senator Specter, it also contains a definition of
lifting 75 pounds once. It also contains definitions which say,
if you lift 25 pounds below the knee, above the shoulders, or
at arm's length more than 25 times per day--25 pounds, 25 times
a day--that constitutes force, and on and on.
These are OSHA's definitions of its risk factors. I would
suggest that economically the impact of these risk factors,
were these to trigger the kinds of job hazard analyses that Ms.
Rhinehart indicates, the impact of these risk factors on our
retrenching economy would be devastating.
Moreover, there is not a scintilla of scientific evidence
or medical evidence to support these exercises in false
precision.
Senator Specter. Mr. Woodward, how about it? What is your
view of what Mr. Fellner is arguing?
Mr. Woodward. I would like to clarify a couple of things
here. This table here, which we refer to as a screen, its only
function is to tell an employer whether it needs to take a look
at a job. There are no limits in here of the kind that would
say you have to have fewer repetitions than what is in the
table.
The function of this table is, if an employee is injured,
and you, the employer, determine that that injury was because
of work, then look at this table and determine if there is at
least that much exposure to risk factors here. The next step is
to do a job hazard analysis to try to figure out whether there
is a hazard. You can use any reasonable method to do the hazard
analysis.
In other words, if your employee is injured and he has
acquired, say, carpal tunnel, and you look at the job and yes,
he does have 2 consecutive hours of repeating the same motion
over and over again, then you have to go further and look at
the job in more detail to see whether or not it is actually a
hazardous job. Put another way, if it is less than that, you
stop. You do not even inquire. You say, well, if there is less
than 2 hours of exposure, I clearly do not need to worry about
this.
Now, let me qualify that. There are certain provisions of
the standard, not the control provisions, that are triggered
when you exceed this amount of exposure. A medical referral for
a medical evaluation and then possible work restrictions is
triggered, and training is triggered, but in terms of whether
controls are triggered: no, the only requirement is to perform
an analysis to try to determine whether there is a hazard.
Just to clarify one other point, the definition is not
twice per minute. It says, repeating the same motions every few
seconds, or repeating a cycle of motions involving the affected
body part more than twice per minute, so there are two concepts
in here. One is, you are doing the same thing every few seconds
for 2 hours in a row without stopping. The other is a cycle
that is a combination of body motions, and whether you complete
that cycle, go through the full cycle more than twice a minute.
To go back to the other issue that was raised as to whether
people have an opportunity to comment on this, that is one of
the issues that will be in the litigation. What the proposal
said was that if somebody was injured and if they were working,
if they were exposed for a significant amount of time to
repetition, for example, then you should look at the job, but
that phrase, significant amount of time, was not defined in the
text of the proposal, so I think that is the point he is
referring to.
There was some discussion in the preamble about scientific
evidence indicating that the 2- and 4-hour level is something
worth looking at, but there was not anything particular in the
text of the proposal.
Senator Specter. Let me come back to the basic point here
on what this means. Risk factors this standard covers, and then
we have the specifics. Are you saying, Mr. Woodward, that even
if the employee's activities fall within those definitions,
that there is not necessarily a violation?
Mr. Woodward. Correct. This is a tool that is part of a
process.
Senator Specter. It is a tool as part of the process, but
that triggers an inquiry as to whether there is inappropriate
work required of the person?
Mr. Woodward. That is correct, whether there is a hazard.
Senator Specter. Then what comes next to make a
determination as to whether, if that is done, there is a
hazard?
Mr. Woodward. Then what the standard says is that the
employer should do a hazard analysis.
Senator Specter. What about a hazard analysis?
Mr. Woodward. It says if these levels are exceeded, the
employer must do a hazard analysis, and it says that there are
several different methods an employer could use to do a hazard
analysis. One method is to hire a professional, a safety and
health person who is knowledgeable in the area and knows
something about ergonomic principles. Another method is to use
one of the enumerated tools that are listed in the standard,
and I think Mr. Fellner was referring to these tools as well as
something that he believes the public needed more opportunity
to comment on, but these are tools that are in the nature of
safe harbors. If you want to use any one of these tools to
conduct a hazard analysis you can do that, that is allowed.
Finally, you can do any other approach that is reasonable.
Senator Specter. Mr. Fellner, your point is that these
factors occur, then a hazard analysis is triggered, and there
has to be a determination as to whether there is a hazard which
is unacceptable, is that your point?
Mr. Fellner. Yes, in part. If I could expand on that a bit,
Senator Specter, and that is, first of all let me address one
of the things that Mr. Woodward said insofar as this screening
out injuries. The word injury is not used in the standard. It
is a musculoskeletal disorder incident.
That term is defined in the context of a list in the
standard of subjective symptoms, including pain, simply pain,
tingling, cramps. That constitutes an MSD incident. Then
question is whether any of these screening criteria which we
refer to in table WD-1 screen anything out. The answer is no.
That, in turn, triggers a job hazard analysis.
The job hazard analysis and its consequences, which is the
mandated use of nine tools that have not been associated in any
way, shape, or form scientifically with eliminating ergonomic
risk factors or eliminating MSD incidents, those nine tools
have to be used, and you have to constantly implement
engineering controls, reengineer your workplace in compliance
with these mandated tools, so the process, soup to nuts, is the
identification of these hazard screens, these action triggers,
which in turn----
Senator Specter. I am going to come back to that. Ms.
Rhinehart has not had a chance to respond, and I see her
anxiously edging forward toward the microphone. Ms. Rhinehart,
what is your view?
Ms. Rhinehart. Thank you. I would just like to back up, if
I could, and put some of this in a little bit of context. OSHA
in this ergonomics rule essentially codified an approach to
ergonomics that many companies are already following, that the
General Accounting Office has recommended as an effective
approach to ergonomics, that NIOSH recommends as an effective
approach to ergonomics, that the NAS in its recent report
suggests is an effective approach to ergonomics.
It is a very broad and very flexible approach to ergonomics
that has employers follow very basic program elements of job
hazard analysis, hazard identification and control, involves
their workers in that process, provides some basic training.
These are elements that have been out there and in use ever
since at least the 1990's, the late 1980's, the 1990's, when
the Department of Labor put out its guidelines for addressing
ergonomic problems in meat-packing plants.
These basic elements that are in the final rule were part
of those red meat guidelines. They have been part of settlement
agreements that OSHA has reached with many companies. Many
companies have voluntarily adopted ergonomics programs centered
around these principles, and there is a reason why they have,
because they work.
There are countless examples in the rulemaking record,
Senator Specter, where companies that have implemented
ergonomic programs centered around these principles have found
that not only are they able to reduce worker exposure to
hazards, they have reduced worker injuries, and they have
reduced the costs associated with those injuries in terms of
Workers Comp costs, lost productivity, other health costs, not
to mention the sparing workers and their families the impact
that these injuries have.
These are serious, debilitating injuries that occur at a
rate of about 600,000 serious injuries per year, and the impact
of these injuries on workers and their families is simply
devastating.
There are effective, known measures centered around these
broad principles contained in the final rule to address this
problem and to reduce that suffering, and save employers money
in the process, and that is why we think that it is important
that we have a final ergonomics standard on the books that
frankly has been--it has been 10 years in the making. It has
been a long time coming. It is no rush to judgment. But
fortunately, finally the time has come, and we do have these
ergonomics protections on the books that we strongly support.
Senator Specter. Mr. Fellner, your position is what? What
about Ms. Rhinehart's statement that these standards represent
a great many practices which have been accepted in the industry
and by these other agencies?
Mr. Fellner. This standard did not receive 10 years of
scrutiny. It did not receive 10 minutes of scrutiny insofar as
notice and comment is concerned. This standard as a regulatory
requirement, which on pain of penalty from compliance officers,
taking this standard out and enforcing it has not been part of
anybody's ergonomics program.
Senator Specter. Is there a pain of penalty if somebody has
the repetitive motion of more than twice per minute for more
than 2 consecutive hours in a work day? Is there a pain of
penalty for some employer who permits that kind of work to go
forward?
Mr. Fellner. If some employer permits that kind of work to
go forward without undertaking the job hazard analysis and the
mandated tools, in Appendix D-1 the answer is absolutely yes.
It is those action triggers that start the ball rolling.
Senator Specter. Now, the job-mandated analysis on
specified tools, elaborate as to what that means exactly, and
why you are opposed.
Mr. Fellner. Job hazard analysis--and we are opposed to
that because we have seen this in the context of OSHA having
issued over 550 general duty clauses--citations under its
omnibus authority for ergonomics issues.
The job hazard analysis and what OSHA has required pursuant
to those citations have involved everything from reengineering
the workplace, slowing the pace of the workplace, hiring more
workers, reducing the weight, changing the entire configuration
of conveyer systems.
There are comments in the record, Senator Specter----
Senator Specter. Mr. Fellner, what would you recommend, or
the ancillary question is, do you believe that there is not a
problem if someone has to do more than twice a minute the same
activity more than two consecutive hours in the work day? Do
you think that is not a problem, or an indicator of a problem
which requires further analysis to decide whether it is a
hazard?
Mr. Fellner. That is correct.
Senator Specter. You do not think that means anything?
Mr. Fellner. I would suggest, with all due respect, that
that indicates how far OSHA has gone if they honestly believe
that repetition is doing something twice a minute, twice a
minute for 2 hours, and that that triggers--the word they use
is action trigger, that that triggers action, including the
worker removal protection, which is independently triggered by
that.
Senator Specter. What is the worker removal test?
Mr. Fellner. The worker removal protection is 90 days at
90-percent pay if one has a subjective MSD incident that I
described earlier.
Senator Specter. 90 days at 90-percent pay in some other
job?
Mr. Fellner. No, sitting at home doing no other job. 90
days at 90-percent pay. We are talking about the most favored
injury clause. If you compare this with any other injury, an
amputation would not yield the same----
Senator Specter. Okay, I understand your point.
What kind of repetitive activity do your experts think
would be hazardous?
Mr. Fellner. That is an extraordinarily complex question,
as complicated as the human being is, and I would respond----
Senator Specter. It is up to a man of your experience to
answer.
Mr. Fellner. I would respond by saying, with respect, look
at the answer of sports medicine. Sports medicine teaches you
that repetition is not bad, but good. Repetition strengthens
the human body. The basic medical premise on which ergonomists
have based this standard is that we are a series of ball-
bearings, we human beings, and that we are going to wear out
over time.
If anyone has an aged parent, if anyone is dealing with
recovery from injury, we know that motion is not bad, but
repetitive motion, and difficult repetitive motion, is good for
the human body, striking that balance. It is a difficult
balance.
Senator Specter. Mr. Fellner I am trying to zero in on
issues which I think will be of concern not only to me but to
my colleagues. Are you saying that there is no problem with
repetition no matter how much repetition there is?
Mr. Fellner. I am saying that that is a question for free
and open debate amongst the experts.
Senator Specter. What do your experts say? You must know
what they say on the subject. If you are disagreeing with the
standard, what is the standard?
Mr. Fellner. Again, we are not in the position to draft a
standard in this hearing room, and I would not be in a position
to condense the experts' views in this hearing room.
Senator Specter. I was thinking of providing 6 to 12
persons on each side to come into this room and have a
discussion about it.
Mr. Fellner. That is not a bad idea.
Senator Specter. When you come down to this next one,
lifting more than 75 pounds at any one time, or more than 55
pounds more than 10 times a day, or more than 25 pounds below
the knees or above the shoulders or at arm's length more than
25 times a day, I think about my experience in my father's
junkyard. At 17, I could lift 100 pounds, but it was tough, and
we had joints of 2-inch casing, tubing, 25 feet long, which
three of us threw on a truck, and more than 100 pounds was
tough.
What happens with women? Are women called upon to lift 75
pounds in their jobs? Are they, Ms. Rhinehart?
Ms. Rhinehart. Absolutely, Senator. One of the industries
with the highest rate of back injuries and other ergonomic
injuries is nursing homes. Nurses' aides and other workers in
nursing homes are required to lift patients who often weigh
more than 100 pounds, and often they are required to lift these
patients on their own, and as a result of that, the rate of
injuries in that industry is rampant.
Can I just go back for 1 second to the repetitions?
Senator Specter. Stay with nursing homes for a second. What
is to be done? Is someone to be with the employee at all times
to help them lift the patient?
Ms. Rhinehart. There are a couple of things that were
discussed extensively in the rulemaking hearings, either that
you have somebody assist you in lifting a patient, or there are
actually mechanical devices that are out there and in use in
hospitals and in nursing homes and in other settings that
assist a worker in moving a patient, and which takes some of
the weight and some of the load off of the worker while still
permitting the patient-handling that needs to be done to occur.
So those devices are out there.
Senator Specter. You had another point you wanted to make.
Ms. Rhinehart. I just wanted to, on the point of repetition
and how much repetition is too much, I would just refer you--
and I would be happy to provide this for the record--to some of
the very compelling testimony during the OSHA rulemaking
hearings from poultry workers, who have birds coming past them
on a line at a rate of 70 birds per minute, and they have to
pull these birds down and make motions and cuts on those birds,
70 birds a minute, every minute, every hour, and I would
suggest that when you take that repetition and combine it with
the effect of that repetition on workers, the skyrocketing
rates of injuries, that is too much.
Senator Specter. I am trying to figure out how to get there
from here. I do not know what the repetition standard ought to
be, and I do not know what the weight-lifting standard ought to
be, but the question, Mr. Fellner, is how we get there, and you
do not like what is being done here, and if you convened
experts in all of these fields who give their testimony, then
you would leave it up to OSHA to make a judgment as to which
expert testimony was correct, and they would then make up a
chart like this one on risk factors this standard covers. Then
there would be an opportunity for the parties to comment, and
then OSHA would consider those comments and come to a final
conclusion. That is what you are suggesting, Mr. Fellner?
Mr. Fellner. That is--definitely, assuming that the new
OSHA concludes that one can segregate the physical factors,
which is what we have talked about, and limited our discussion
this morning, from the myriad of other factors acknowledged by
the World Health Organization, the National Academy of
Sciences, and others, including psychosocial factors, social
factors, cultural factors, gender, genetics, and a variety of
other factors, all of which contribute to these MSD incidents
that we talked about before.
And assuming that the new OSHA concludes, as well, that it
is in a position to distinguish that which takes place in the
workplace from that which is caused outside of the workplace,
especially since there is so much of a conglomeration, if you
will, of these factors together.
Assume that all of these pieces can be appropriately
understood by the new OSHA, and assume that physical factors
can be segregated from all of the rest which have been
acknowledged even by the experts that Ms. Rhinehart relies on.
Then what you have described is an entirely appropriate way of
approaching the issue, but the assumptions are not yet well
understood.
Senator Specter. Let us go to the issue of cost. What has
OSHA estimated the cost to be, Mr. Woodward?
Mr. Woodward. OSHA estimated the cost of this standard at
roughly $4.5 billion per year. This is an annualized cost;
there are several components to that estimate. There is the
cost of the program elements. In other words, you have to train
employees according to this standard. That takes time. That is
a cost. There is the cost of the controls that you would have
to put in if you find that there is a hazard that needs to be
controlled. There is also the cost of the work restriction
protection, maintaining an employee's earnings, if you
determine the employee is injured and that he cannot perform
his normal duties.
Senator Specter. How do you come to the figure? What is
your methodology?
Mr. Woodward. The biggest single part of it, according to
OSHA, is the program cost. Those were roughly $2 billion, a
little more than that.
Senator Specter. How do you determine that?
Mr. Woodward. The current standards requires employers to
do various things. They have to set up a system by which
employees can report their injuries to them. They have to give
employees information about these type of injuries. They have
to train them. They have to do hazard analysis. What OSHA did
is to list those activities and then try to figure out how much
time it typically would take an employer to do that. That
computation was in the final rule largely based on testimony
about existing ergonomics programs.
People testified about their ergonomics programs. For
example, it takes us x hours to train our employees, and other
people had a different estimate, and they said, it takes us y
hours. The agency reviewed those estimates and came out in the
middle. Basically, that was how OSHA calculated the program
part of the cost.
For the work restriction protection part, OSHA received
from BLS an estimate of how many workers are currently off work
due to this type of injury. Then OSHA made an adjustment
because they think there is underreporting, and that the real
number, after this standard goes into effect would be greater
since more people would be reporting their injuries.
Then OSHA looked at what BLS says is the median amount of
time people are out of work because of these injuries. I think
it is 7 days for musculoskeletal disorders as a whole, although
it varies depending on which type of disorder you are talking
about.
That was how OSHA calculated the number of days, and then
they looked at the earnings in different industries and
occupations and made an adjustment for the fact that some of
this is currently being covered by Workers' Compensation. OSHA
subtracted that amount from the cost, since that was already
being borne, and from that they obtained an estimate of $600 or
$700 million a year. I believe it was an estimated $630 million
a year.
Then there was the control cost presented, what OSHA termed
it, difficult issues related to costing. What OSHA did was
convene a panel of practicing ergonomists and asked them to
estimate what they thought, based on their experience, on
average, it would cost to fix a hazardous job in a particular
occupational grouping. Based on that, the experts then tried to
estimate, how many people are in that occupational grouping in
different industries and obtained an estimate.
Senator Specter. Was there a calculation as to benefit as a
result of the regs to offset the cost?
Mr. Woodward. Yes.
Senator Specter. What was that figure?
Mr. Woodward. OSHA estimated 4.6 million disorders would be
prevented over the first 10 years, and there was a partial
monetary value assigned to that. In other words, OSHA did not
try to cost pain and suffering, but they did estimate that
there was about $9.1 billion of other value from the rule.
Senator Specter. What is the total value, Mr. Woodward,
calculated by OSHA?
Mr. Woodward. $9.1 billion, I believe.
Senator Specter. What do you think about those figures, Mr.
Fellner?
Mr. Fellner. Those figures make this the most expensive
regulation in OSHA's history, and those figures are minuscule
compared to what the real figures are. The litmus test for what
this standard will cost American industry lies in the citations
that OSHA has issued over the last 10 years on ergonomics.
These are citations that will be issued by the same compliance
officers using the same measures, the same tools, and the same
requirements for fixes.
We have for a number of clients taken a look at the
specific recommendations that OSHA has made to fix these risk
factors that we have talked about earlier, and we put a price
tag on them. That price tag is anywhere between $100 billion
and $1 trillion, and lest that be viewed as an exaggeration, we
must continue, we in industry, under this standard which is the
subject of this hearing, we must continue to experiment and
force technology until we are down to the screening tools, so
that the action triggers are no longer activated, because we
know we are going to get those MSD incidents. We know we are
going to get complaints with regard to back pain.
So consequently the process by which--for example, there is
a comment filed by Federal Express in the record which, simply
put, states that next-day delivery will cease if the OSHA
standard is promulgated. There is testimony in the record, as
you can well imagine, from funeral directors indicating that
burials will no longer take place if the precise kinds of
requirements in this standard are, in fact, effectuated.
Senator Specter. When you say burials will not take place,
do you mean they will be delayed?
Mr. Fellner. No. I am suggesting to you, Senator Specter,
you cannot lift a human body, unless it is wasted down to below
75 pounds, and that is what I am suggesting, and that is what
the testimony in an uncontradicted fashion indicates in the
record.
Senator Specter. What about that, Mr. Woodward?
Mr. Woodward. There is nothing in the rule that says you
cannot lift a person who is more than 75 pounds. I do want to
acknowledge that, as the Secretary has said, these are very
complicated issues. Many issues have been raised about the way
the current rule is structured, and we acknowledge that, and we
are in litigation. No briefing schedule has been set, no oral
argument set, but we acknowledge that a number of issues have
been raised about it.
Senator Specter. Mr. Fellner, how do you get to your
calculation of $100 billion to $1 trillion in cost?
Mr. Fellner. If one were to take across the vast array of
American industry the specific requirements, and we are not
talking about the hours it would take to absorb. I am not sure
whether Mr. Woodward said it takes 1 hour or 2 to absorb this
608-page standard, together with its preamble.
We are not talking about the number of hours that it takes
to study and understand an incomprehensible regulation. We are
talking about the nuts and bolts, as I indicated to you
earlier, that it would take to comply, after the job hazard
analysis, with this regulation. This is not a matter of putting
a phone book under a desk, which some of our union friends have
indicated.
This is not simply a matter of simple, quick fixes. This is
experimenting with pace, with employees, with automation, and
the bottom line here, the great irony here is that our friends
in the labor movement, who are very, very much behind this
standard--and I acknowledge the good faith with which they
approach the arguments favoring this standard, as I did 2 weeks
ago when Lynn and I were on an ABA/OSHA subcommittee panel
together discussing the very same issues.
The issue is not that good faith. The great irony is that
this standard will push two things, one, jobs going abroad, and
two, automating employees out of jobs, because robots do not
complain about low back pain.
Senator Specter. Mr. Fellner, can you come to grips a
little more directly with the way you come to the computation
of cost of $100 billion to $1 trillion?
Mr. Fellner. The Employment Policy Foundation has submitted
a detailed document indicating that the range is $100 billion
without relying on the specific numbers for implementing these
5(a)1, these general duty clause citations.
Senator Specter. What is the basis of that computation?
Mr. Fellner. The basis of that computation is using a more
realistic analysis of the hours, the time, and the
implementation of job hazard controls.
Senator Specter. They say $100 billion?
Mr. Fellner. They say in excess of $100 billion, and that
is part of the record.
Senator Specter. Do they say as much as $1 trillion?
Mr. Fellner. They do not say as much as a trillion. That
reflects an extrapolation from specific 5(a)(1) citations,
which I indicated earlier.
Senator Specter. Who made that extrapolation?
Mr. Fellner. We did, in the context of our submissions to
the OSHA record.
Senator Specter. Mr. Woodward, what do you think about
that? Your $4.5 billion compared to their $100 billion?
Mr. Woodward. OSHA explained its reason in some detail, and
OSHA concluded that most of these fixes were relatively
inexpensive, more in the range of $800 to $1,000, to fix a
hazardous job. That was based largely on testimony of what
people currently do to abate a hazard. There is a huge range,
so we are talking about an average. Some people disagreed with
that.
One reason some of the other estimates are so high is
because they interpreted the provisions of the standard
differently than OSHA interpreted them. For example, one
requirement is to provide your employees information about
musculoskeletal disorders--what are they, what they should be
aware of--so they can report.
One of the cost estimates was based on the idea that it
would take 60 hours with each employee to convey that
information, whereas OSHA's interpretation of the requirement,
was that you could simply provide a written explanation to the
employee of what to look for. So I think there are some
differences in how the standard was interpreted. That is one of
the factors.
Because we were in rulemaking, the estimates were directed
toward the proposed rule, and there were some differences with
the final rule. I think that also is a factor here.
Senator Specter. Mr. Fellner, did your computations take
into account a benefit contrasted or similar to what Mr.
Woodward has testified to? When he says there were $4.5 billion
in cost, he says there were $9.1 billion in benefits. Did your
analysis take into account the benefit factor?
Mr. Fellner. In point of fact, our analysis indicates that
the benefits are largely overdrawn. The BLS statistics upon
which they are based are roundly criticized by the National
Academy of Sciences, which is seeking properly a much more
sophisticated analysis of the so-called MSD incidents. The BLS
statistics are much too rough a tool.
Senator Specter. Is there no benefit?
Mr. Fellner. As a matter of fact, the initial--as OSHA
concedes, the initial stage of this ergonomics standard will be
iatrogenic, and by that I mean it will increase the number of
MSD incidents that are reported in the workplace, because to a
certain extent we are teaching employees how to be sick, and in
the context of heretofore having coped with musculoskeletal
pain and discomfort, and overcome it, as all of us do, OSHA
would turn the tables on that particular point, and so in many
respects the benefits that OSHA has indicated are illusory, and
if I may further add, Senator----
Senator Specter. Is that a no answer?
Mr. Fellner. No, it is not a no answer. We do acknowledge
that there may be some benefits, as there would in the so-
called Hawthorne effect. Turning your attention to any problem
will, from a variety of different perspectives, potentially
ameliorate those problems, and that is a psychosocial aspect of
that amelioration.
But let me, if I may----
Senator Specter. You may, but first tell me if you have a
figure on benefits. You say that there may be benefits. Do you
have a figure on benefits?
Mr. Fellner. I do not.
Senator Specter. You were pretty fast on $100 billion to $1
trillion, but no figure on benefits?
Mr. Fellner. If I were to accept, which I do not, the $9
billion number that OSHA has put forth in the context of the
standard, it is swallowed up by the costs, so as we see them
and as they are demonstrated clearly in the record, i.e., $9
billion in benefits, even assuming that were accurate, is more
than swallowed up by their $100 billion to $1 trillion in
costs.
So under the circumstances benefits is a negligible factor
in this equation, particularly, if I may, if one looks at what
Mr. Woodward has indicated is one of the methodologies of
determining benefits, which is getting their selected
ergonomists in a room with a huge range, insofar as the
benefits and the costs that they determine of this standard, a
huge, inconsistent, subjective range, if their way of coming up
with benefits of interventions is, as one of the case studies,
quote-unquote, which they rely on, which is a Continental Air
magazine----
Senator Specter. I think I have your point.
Mr. Fellner [continuing]. Which was taken out of a seat.
That is the way they determine benefits.
Senator Specter. With $4.5 billion in costs and $9.1
billion benefits estimated by OSHA, and your figures of $100
billion in costs ranging up to $1 trillion. I am trying to find
some basis for rational congressional evaluation of what is
going on here and it is a swirl. It is an absolute swirl.
I do not understand much of what Mr. Woodward says as to
his $4.5 billion in costs, and I understand less from what you
have said of the range of $100 billion to $1 trillion. That is
a pretty big range, and if we go through the rulemaking process
again, how is there going to be an evaluation?
One of the things I asked in a meeting that I held
informally that you did not attend, Mr. Fellner, was the
possibility of bringing the contestants together to see if
something could be worked out, to see if there could be some
agreement.
When the telecommunications bill was passed with all its
complexities, the parties finally got together, and we do
facilitate that from time to time. Is there any possibility of
doing that, Mr. Fellner, so that experts can draw the lines of
disagreement and compromise?
Mr. Fellner. In the context of this regulation the answer
is no.
Senator Specter. How about the next regulation, if there is
one?
Mr. Fellner. The answer is yes, obviously, if there is one.
Senator Specter. This massive regulation, which I have
heard described as 300 pages, and then I have heard it further
described, and correct me if I am wrong, Mr. Woodward, as nine
pages of regulations, 16 pages of fact sheets in support, and
the balance of public comments, is that accurate, Mr. Woodward?
Mr. Woodward. That is correct.
Senator Specter. Is that accurate, Mr. Fellner?
Mr. Fellner. That is inaccurate.
Mr. Woodward. The rest of the package is what we call the
preamble. It is an explanation of the rule, and it is a
justification in terms of the evidence, the scientific evidence
that was presented, and the economics.
Senator Specter. But you are saying there are only nine
pages of regulation.
Mr. Woodward. The regulatory text, yes, that is correct.
Mr. Fellner. Any employer, if I may interrupt, any employer
who would attempt to take action based upon 9 pages of standard
and 16 pages of fact sheets without knowing what is in the
preamble, given my experience insofar as OSHA standards are
concerned, with much shorter preambles than this, is engaged in
a very risky business.
To understand the standard is to understand OSHA's
interpretations in its preamble. Indeed, we will not know what
OSHA means by this standard until it comes out with its
enforcement directive, which it has declined to do up until
now, because there is extraordinary confusion as to what this
standard means.
Senator Specter. How about that, Mr. Woodward? How about
the enforcement directives?
Mr. Woodward. We normally do issue what we call a
compliance directive. As I said, the Secretary has noted that
these are complicated issues, and that the entire standard has
been under review. We have not issued a compliance directive
yet. The compliance directive does not change the meaning of
the nine pages of text. It cannot do that. But any of these
materials can interpret the rule and, to that extent, provide
guidance.
Senator Specter. The issue has been raised as to whether
any new regulation, if this one falls under the Congressional
Review Act, will be fatally inhibited by the provision in the
statute which precludes a new rule, if it is reissued in
substantially the same form. Is there any problem at all, as
you see it, Mr. Fellner, in having a new regulation which will
be permitted under the Congressional Review Act, and not
prohibited by being substantially in the same form by the rule
prohibiting a regulation: ``reissued in substantially the same
form''?
Mr. Fellner. This being the first time that the CRA will be
tested, we are clearly in uncharted waters as to what
substantially the same form means, so let me very carefully and
very gingerly respond to your question, Senator Specter, and
suggest that a standard that contains the kind of very
specifically mandated formulae and definitions that this
standard contains, and would hold employers to those
definitions and to those requirements, and I am specifically
talking about W-1, which we talked about earlier, as well as
appendix D-1, that that kind of standard may very well fall in
the substantially similar rubric, as outlined by the CRA, but
we do not know that, and we will not until good lawyers like
Lynn and hopefully myself test it in the courts.
Senator Specter. So there is some possibility that there
might be some litigation?
Mr. Fellner. After the next standard comes out, that is
correct, there may very well be.
Senator Specter. Do you think there is any conceivable
possibility there would not be enormous litigation?
Ms. Rhinehart. Two years ago at an ABA meeting I promised--
--
Senator Specter. Wait a minute. I want to hear his answer.
Mr. Fellner. Do I think it is----
Senator Specter. Do you think there is any possibility at
all, any remote, contingent possibility that there would not be
litigation that a new regulation is barred by the
substantiality requirement I just read?
Mr. Fellner. The answer is, if we all do our jobs, and we
come up with a consensus, there is a good chance that
litigation could be avoided.
Senator Specter. Ms. Rhinehart, you wanted to say
something.
Ms. Rhinehart. I did. I just wanted to----
Senator Specter. I did not want to let you come in before
Mr. Fellner had a chance to answer.
Ms. Rhinehart. And the fact that they may not sue OSHA over
a subsequent standard is welcome news indeed. I just wanted to
say that the AFL-CIO is very concerned about the impact of
passage of a resolution of disapproval under the Congressional
Review Act on the agency's ability to issue a standard in this
area in the future, and I think what we have just heard from
Mr. Fellner is evidence as to why we are right to be concerned.
OSHA made some modifications in this final rule to be a
little more specific, and to give employers some more guidance
because the employers asked for it. Now we are hearing from Mr.
Fellner that they do not like that specificity, and they want
to go back to a broad, more general standard. Well, that is
what they had, and they did not like that, either.
The fact of the matter is that many trade associations and
a large part of the employer community has vociferously opposed
any ergonomics regulation, so the notion that if Congress were
to pass this resolution of disapproval and send OSHA back to
the drawing board, that there would be a change of heart and
all of a sudden we would all be collaborating and embracing a
new rule in the future seems a bit far-fetched, in our view,
and so we are very concerned about the effect of passage of a
resolution on OSHA's future ability to act.
We would like to believe they could act. We obviously are
very interested in there being a good, strong ergonomics
standard to protect workers, and we will do everything we can
toward that end, but we are very concerned.
Thank you.
Senator Specter. Does anybody care to comment any further?
Additional statements for the record will be included at this
point, including a letter from Secretary Chao.
[The statements follow:]
Prepared Statement of LPA, Inc.
Mr. Chairman and Members of the Subcommittee: LPA is pleased to
submit testimony opposing the Occupational Safety and Health
Administration's (OSHA's) final ergonomics standard, which has been
estimated by the Employment Policy Foundation to impose annual costs on
employers of as high as $126 billion, probably making it the most
expensive workplace regulation in history. The final standard, which
OSHA completed in less than 11 months, was less an attempt to
promulgate a sound workplace regulation than the fulfillment of a
political promise by President Clinton to organized labor. Politics
should give way to reasonable regulation, and thus Congress should
invalidate the standard using the Congressional Review Act, allowing
OSHA to try again.
LPA, Inc., is an association of the senior human resource
executives of more than 200 leading corporations in the United States.
LPA's purpose is to ensure that U.S. employment policy supports the
competitive goals of its member companies and their employees. LPA
member companies employ more than 12 million employees, or 12 percent
of the private sector workforce. If the final ergonomics standard
remains in effect, it will cover nearly all of our member companies and
virtually all of their employees.
In short, LPA supports the application of ergonomic principles to
the workplace. However, it opposes the final ergonomics standard
because it covers ergonomics disorders caused by non-work activities,
is not based on sound science, ensures that most employers will be
required to set up ergonomics programs, and creates unacceptable
conflicts with state workers' compensation laws. Instead, LPA supports
the Senate joint resolution of disapproval sponsored by Sen. Don
Nickles (R-OK), S.J. Res. 6, which would invalidate the final standard
and allow OSHA to regulate workplace ergonomics in a more reasonable
manner.
Final standard covers non-work-related disorders
OSHA's final ergonomics standard fails to substantially narrow the
definition of work-related musculoskeletal disorder (MSD). The final
standard purports to cover workrelated MSDs, but broadly defines that
term as those that work caused, contributed to, or for pre-existing
MSDs, significantly aggravated. The Preamble defines ``significantly
aggravated'' as having an injury already ``but because of the
employee's exposure to identified risk factors in the workplace, the
MSD has progressed to the extent that medical treatment is now
necessary.'' Reading between the lines, this means that if work
exposure played any role in an employee-reported MSD, then the MSD is
work-related.
NAS study shows that final standard not based on sound science
One of the key arguments in opposition to the final ergonomics
standard is that OSHA has failed to conclusively prove that work
factors cause MSDs. The National Academy of Sciences (NAS) study
completed in January 2001 was intended to solve this debate. The study
reviewed existing scientific literature in order to determine whether
science has affirmatively linked injuries to workplace exposures.
However, it only demonstrated that more research was required in this
complex area.
The NAS panel concluded that ``[n]one of the common musculoskeletal
disorders is uniquely caused by work exposures,'' that there are no
comprehensive national data on medically defined MSDs, and that the
available data is mostly based on employee reporting, not a diagnosis
from a health care provider. It cautioned that often it is difficult to
scientifically distinguish work exposures that may cause MSDs from
other life exposures that cause them because 80 percent of the
population works, further complicating research on the issue. The panel
concluded that significant additional research is needed in this area.
The NAS panel also noted that MSDs are affected by many non-work
factors, such as age, gender, healthy lifestyles, and the effect of
other diseases such as diabetes. The panel spent a considerable amount
of time discussing how psychosocial factors, such as high perceived
stress, low job satisfaction, monotony, and low social support increase
the chances of developing an MSD in the lower back.
Despite the unspoken preference for unanimity in such reports, the
NAS panel drew a rare dissent from panel member Dr. Robert Szabo. Dr.
Szabo criticized the panel for using inaccurate scientific literature,
particularly regarding carpal tunnel syndrome. He highlighted the
studies that indicated that personal factors, age, lifestyle and sex as
more predictive of carpal tunnel syndrome than job exposure. He also
noted that the cited studies only demonstrate that job controls reduce
the symptoms of disease but do not address whether they reduce the
underlying soft tissue disease. Taken as a whole, the evidence cited by
Dr. Szabo with respect to carpal tunnel syndrome casts doubt on the
remainder of the NAS conclusions.
Triggers easily met
Once an employee has reported a work-related MSD, an employer must
set up a full ergonomics program if the reported MSD meets two
``triggers'' or tests set under the standard. The first stage of the
trigger is met if the MSD involves days away from work, work
restrictions (such as the inability to work scheduled or mandatory
overtime) or medical treatment beyond first aid. It is also met if an
employee feels tingling or other MSD symptoms in his or her arm for
seven consecutive calendar days. Given that it in not unusual for
employees to experience symptoms or to request work restrictions
occasionally, the first trigger is often met.
Once the first stage of the trigger is met, the employer must
determine whether the employee's job exceeds certain action thresholds.
In many cases these thresholds are also easy to meet. For example, an
administrative employee who regularly works steadily at his or her
keyboard for four hours or more per day would trigger a full ergonomics
program for all people performing similar jobs, if he or she reported a
work-related MSD and was unable to work overtime for one day.
Taken together, the overbroad definition of work-related and the
low job task thresholds mean that the standard will cause most jobs to
be covered by the ergonomics standard.
Standard interferes with State workers' compensation laws
The final ergonomics standard would require employers to provide 90
days paid leave at 90 percent of an employee's gross earnings to any
employee who has been determined unable to work by a health care
professional. This requirement, called ``work restriction protection,''
is a blatant violation of section 4(b)(4) of the Occupational Safety
and Health
Act (OSH Act), which states that an OSHA standard may not
``supercede or in any manner affect'' any state workers' compensation
law.
The ergonomics standard will interfere substantially with state
workers' compensation laws in several ways, including:
--preempting the exclusive remedy provisions;
--invalidating state standards on injury and causation;
--undermining the return-to-work incentive; and
--increasing state costs because of increased claims and benefit
duration.
Although OSHA has proposed and enforced work restriction protection
provisions in other, narrower standards, it has never attempted to
apply it in a wide-ranging standard that applied to virtually all
general industry employees. Because the ergonomics standard would apply
to most employees of most employers, significant conflict between the
work restriction protection requirement in the OSHA standard and state
workers' compensation laws is a virtually certain, and thus, illegal.
LPA urges support for congressional resolution of disapproval
Mr. Chairman, because OSHA's final ergonomics standard is
fundamentally flawed, LPA recommends that Congress invalidate the
current standard by passing S.J. Res. 6, the joint resolution of
disapproval introduced by Sen. Nickles. If the Senate and the House of
Representatives both approve the resolution by a simple majority vote,
and it becomes law, the ergonomics standard is invalidated.
Contrary to the assertions of organized labor and other opponents
of the resolution, a successful resolution would not prevent OSHA from
issuing an ergonomics standard. Rather it would preclude OSHA from re-
issuing the current standard or one that is substantially similar. LPA
believes this is a reasonable and measured step to take given the great
costs to the economy, employers, employees and states imposed by the
existing standard.
CONCLUSION
OSHA's final ergonomics standard is unworkable because it applies
to disorders that are not related to work, is based on inadequate
science and would cause a substantial conflict with state workers'
compensation laws. LPA endorses the attempt to pass a congressional
resolution of disapproval to rid the country of this flawed standard
and to allow OSHA to pursue a more reasonable approach.
Thank you for the opportunity to present our views.
______
Prepared Statement of the AFL-CIO
NATIONAL ACADEMY OF SCIENCES/INSTITUTE OF MEDICINE REPORT SUPPORTS THE
OSHA ERGONOMICS STANDARD
The National Academy of Sciences and the Institute of Medicine
recently released their long awaited report on Musculoskeletal
Disorders and the Workplace. The report, requested by industry groups
and conservative Republicans who opposed an OSHA ergonomics standard,
finds that there is strong scientific evidence showing that exposure to
ergonomic hazards in the workplace causes musculoskeletal disorders and
that these injuries can be prevented. Prepared by some of the world's
top scientific and medical experts in ergonomics, the report calls MSDs
an important national problem and strongly supports the approach that
OSHA took in its final Ergonomics Program Standard, released November
14, 2000.
This is the third comprehensive review of the scientific literature
over the past four years that has come to the same conclusions. The
National Institute for Occupational Safety and Health (NIOSH) published
a comprehensive review of the data on the relationship between MSDs and
the workplace in 1997. The NAS also came to similar conclusion in an
earlier report published in 1998.
The NAS report puts to rest, once and for all, the claims by some
industry groups and conservative Republicans that there is no
scientific evidence that workplace exposures cause musculoskeletal
disorders. It shows without question that OSHA's new ergonomics
standard is needed and justified.
Musculoskeletal disorders are an important national health problem
The NAS report confirms OSHA's estimates of the scope of the
problem, citing an even larger number of workers losing time from work
than OSHA. The NAS estimates that one million people lose time from
work each year due to these disabling injuries, compared with OSHA's
more conservative estimate of 600,000. The NAS also confirms OSHA's
estimate that ergonomic problems cost the economy around $50 billion
each year. The report warns that MSD-related problems are expected to
increase in the future due to the changing nature of work, the aging of
the workforce and rising numbers of women entering material handling
and computer jobs.
The report also finds that existing national data sources conclude
that construction and agricultural workers, who were not covered in the
OSHA standard, also suffer higher rates of work-related MSDs than
overall industry.
``There is no doubt that musculoskeletal disorders of the low back
and upper extremities are an important and costly national health
problem . . . In 1999, nearly 1 million people took time away from work
to treat and recover from work-related musculoskeletal pain or
impairment of function in the low back or upper extremities.
Conservative estimates of the economic burden imposed, as measured by
compensation costs, lost wages, and lost productivity, are between $45
and $54 billion annually.'' (Page ES-1)
``The consequences of musculoskeletal disorders to individuals and
society and the evidence that these disorders are to some degree
preventable justify a broad, coherent effort to encourage the
institution or extension of ergonomic and other preventive
strategies.'' (Page ES-6)
``As the workforce ages and as more women enter the workforce,
particularly in material handling and computer jobs, evaluation of work
tasks, especially lifting, lowering, carrying, prolonged static
posture, and repetitive motion, will be required to guide the further
design of appropriate interventions.'' (Page 11-2)
Science strongly supports the fact that there is a strong relationship
between workplace physical tasks and the risk of MSDs
The NAS found a strong and consistent pattern of evidence from both
epidemiologic studies (studies of groups of people experiencing similar
exposures), as well as ``biomechanical'' evidence (the actual damage
that ergonomic stress does to muscles, tendons and nerves.) The report
cites the same workplace risk factors that OSHA cites in its standard--
heavy lifting, repetition, force, frequent bending and twisting
(awkward postures) and vibration. The report actually goes beyond the
OSHA standard, including whole body vibration as a risk factor for back
injuries, where OSHA only regulates hand-arm vibration.
While more research and better quality studies are clearly
desirable, the NAS report finds that the consistent overall pattern of
evidence from existing studies clearly confirms the relationship
between workplace physical exposures and MSDs.
``The basic biology and biomechanics literatures provide evidence
of plausible mechanisms for the association between musculoskeletal
disorders and workplace physical exposures.'' (Page ES-6)
``The panel's review of the research literature in epidemiology,
biomechanics, tissue mechanobiology, and workplace intervention
strategies has identified a rich and consistent pattern of evidence
that supports a relationship between the workplace and the occurrence
of MSDs of the low back and upper extremities.'' (Page ES-3)
``The panel concludes that there is a clear relationship between
back disorders and physical load; that is, manual material handling,
load movement, frequent bending and twisting, heavy physical work, and
whole-body vibration. For disorders of the upper extremities,
repetition, force and vibration are particularly important work-related
factors.'' (Page 11-10)
``Occupations that involve repetitive lifting, e.g. warehouse work,
construction and pipe fitting, particularly when that activity involves
twisting postures, are associated with an increased risk for the
complaint of low back pain and, in a few studies, an increased risk for
lumbar disc hemiation.'' (App. A-6)
``Low back disorder risk has been established through epidemiologic
studies of work that involves heavy lifting, frequent bending and
twisting and whole body vibration, as well as other risk factors . . .
. Biomechanical studies reinforce the epidemiologic findings.'' (Page
ES-3)
``The pattern of evidence for upper extremity disorders, as for the
low back, also supports an important role for physical factors,
particularly repetition, force and vibration. The most dramatic
physical exposures occur in manufacturing, food processing, lumber,
transportation and other heavy industries, and these industries have
the highest rates of upper extremity disorder reported as work
related.'' (Page ES-4.)
``There is strong support across these bodies of work that high
force and repetition are associated with musculoskeletal disorder of
the upper extremities; basic biology data provide evidence of
alteration in tissue structure.'' (Page ES-4)
``These exposure-response associations persist when adjusted for
individual factors that may increase vulnerability, such as age, gender
and body mass index.'' (Page ES-4)
``The BLS and workers' compensation data are sufficient to (1)
confirm that the magnitude of the work-related musculoskeletal disorder
problem is very large; (2) demonstrate that rates differ substantially
between industries and occupations consistent with the assumption that
work related risks are important predictors of musculoskeletal
disorders.'' (Page 2-17)
Science strongly supports the fact that workplace interventions based
on ergonomic principles can reduce the risk of MSDs
The report also confirms the fact that using ergonomic principles
to reduce exposure to risk factors reduces the risk of MSDs. Changing
the design of tools and workstations, rotating jobs and other
ergonomics interventions such as lift tables and vibration dampening
seating devices that reduce ergonomic risk factors have been shown to
reduce the risk of MSDs of the low back and upper extremities.
``The weight of the evidence justifies the introduction of
appropriate and selected interventions to reduce the risk of
musculoskeletal disorders of the low back and upper extremities.''
(Page 11-2)
``The intervention literature supports the efficacy of tool and
workstation design changes, job rotation, and other interventions that
directly address these risk factors with regard to upper extremity
symptomology.'' (Page ES-4)
``Intervention studies have shown how lift tables and lifting
hoists are effective in mediating the risk of low back pain in
industrial settings. Since risk is lowered when the load is changed
from a heavy lift to a light lift, this finding is also consistent with
the rigorous epidemiologic finding.'' (Page ES-3)
``Based on the current evidence, modification of the lifting can
reduce symptoms and complaints. Specific successful strategies, which
include ergonomic interventions (such as the use of lift tables and
other devices and matching the worker's capacity to the lifting tasks),
administrative controls (such as job rotation), and team lifting,
appear successful. Despite enthusiasm for their use, there is marginal
or conflict evidence about lifting belts and education programs in
reducing low back pain in the population with heavy lifting
requirements.'' (Page App. A)
The NAS report supports the main elements included in the OSHA standard
The NAS Report found that employers with effective-ergonomics
programs use a programmatic approach that OSHA adopted in its standard.
The OSHA standard requires employers to include several basic program
elements in approaching ergonomic problems: Management Leadership and
Employee Participation, Job Hazard Analysis and Control, Training,
Medical Management and Program Evaluation. These are the same common
elements that the NAS report found in successful ergonomics programs.
This programmatic approach provides a framework for employers; it does
not dictate how employers are to address the problems. The standard
fully allows and anticipates that employers will tailor their programs
to meet the own specific needs of their workplace and work
organization. The NAS report found this approach to be effective in
small and large companies from a variety of industries.
``To be effective, intervention programs should include employee
involvement, employer commitment and the development of integrated
programs that address equipment design work procedures and
organizational characteristics.'' (Page ES-6 and 11-2)
``The complexity of musculoskeletal disorders in the workplace
requires a variety of strategies that may involve the worker, the
workforce, and management. These strategies fall within the categories
of engineering controls, administrative controls, and worker-focused
modifiers. The literature shows that no single strategy is or will be
effective for all types of industry; interventions are best tailored to
the individual situation. However, there are some program elements that
consistent recur in successful programs:
``1. Interventions must mediate physical stressors, largely through
the application of ergonomic principles.
``2. Employee involvement is essential to successful
implementation.
``3. Employer commitment, demonstrated by an integrated program and
supported by best practices review, is important for success.'' (Page
App. A-6)
``These findings are based on a research and development process
that tailors interventions to specific work and workers conditions and
evaluates, on a continuing basis, the effectiveness of these
interventions in the face of changing workplace and worker factors. It
is therefore neither feasible nor desirable to propose a generic
solution.'' (Page ES-5)
______
Prepared Statement of the American Health Care Association
AHCA PRAISES USE OF CONGRESSIONAL REVIEW ACT TO RESCIND ERGONOMICS
REGULATION
Washington, DC.--The American Health Care Association (AHCA) today
praised Senator Don Nickles (R-OK) and Senator Mike Enzi (R-WY) for
invoking the Congressional Review Act in their effort to rescind a 600-
page ergonomics regulation due to become law unless quick action is
taken by Congress.
``Our membership is actively working to help ensure this
excessively burdensome regulation does not become law, and we're
pleased to work with Senators Nickles and Enzi on this critical
issue,'' stated Charles H. Roadman II, M.D., President and CEO of AHCA.
``This ergonomics rule would impose yet another crushing financial
burden costing long term care providers $1.2 billion at a time when we
are being squeezed on many different fronts. We have to be strong
advocates for our patients by being zealous guardians of the scarce
resources allocated by the government for long term care.''
Late last week, Nickles, Enzi and several other Senators introduced
a ``resolution of disapproval'' under the Congressional Review Act. If
the resolution is approved by a simple majority in the Senate and
House, and is signed by the President, the ergonomics rule will not
become law.
Dr. Roadman reiterated AHCA's position that reducing work-related
injuries and protecting employees is best accomplished not through
costly new federal regulations, but through ongoing voluntary efforts
that are already working. AHCA has supported, created and promoted
ergonomic programs to improve workplace safety for the caregivers in
long term care for nearly a decade.
``We believe the proposed rule will actually reverse the positive
trend toward lower rates of workrelated injuries because it will divert
limited resources away from further improvements,'' said Dr. Roadman.
``Just as the federal government has started to correct the errors made
in the implementation of federal Medicare cuts, the last thing
providers need is a new federal regulation that will drain $1.2 billion
of scarce resources out of facilities to implement on a nationwide
basis.''
copy of the letter sent to all u.s. senators and house members
March 1, 2001.
[Each Letter was Personally Addressed and Signed to Individual Members
of Congress]
On behalf of the American Health Care Association (AHCA), a
federation representing over 12,000 non-profit and for profit nursing
home, assisted living, subacute and ICFMR providers of long term care
nationwide, I am writing to urge your strong support of the
Congressional Review Act and your vote for the resolution of
disapproval of the OSHA Ergonomic regulation.
Let me state up front that AHCA has supported, created and promoted
ergonomic programs to improve workplace safety for the caregivers in
long term care for a decade. As caregivers our primary mission is to
treat our patients and provide them with a high quality of life. This
can only be successfully accomplished if our employees work in a safe,
secure, and healthy environment.
The fact of the matter is that the incidences of musculoskeletal
disorder (MSD) injuries in long term care have been in decline, and
continue to decline. Bureau of Labor Statistics (BLS) data show that
from 1993 to 1997 sprains and strains numbers (the number one problem
for health care employees) declined by 16.7 percent. BLS data released
in December 1999 shows the decline to be continuing. Clearly, current
programs and voluntary efforts to reduce MSDs are working. Indeed, AHCA
believes that the ergonomics final rule will actually retard and even
reverse this positive trend toward lower rates of work-related
injuries.
Long term care employers are in a box with no way out with respect
to the resources available to them to help pay for this new standard.
Medicaid or Medicare pays for the medical care for nearly 80 percent of
residents in nursing facilities today. AHCA has estimated that the
first year's cost for long term care facilities is almost $1.2 billion.
The reality is that there is no way to increase prices to pay for the
costs of this standard. The $1.2 billion will have to come from
existing patient care resources, with questionable employee safety
benefit from the rule's implementation.
We strongly urge you to prevent this regulatory attack on caregiver
resources, and allow a more reasoned approach to intelligent safety
programs. Thank you for your attention to this critical vote.
Sincerely yours,
Charles H. Roadman II, MD,
President and CEO.
______
Letter From Secretary Elaine L. Chao
Secretary of Labor,
Washington, March 6, 2001.
Hon. Arlen Specter,
Chairman, Subcommittee on Labor, Health and Human Services, Education,
Committee on Appropriations, U.S. Senate, Washington, DC.
Dear Chairman Specter: It is my understanding that the Senate will
soon consider a Joint Resolution of Disapproval pertaining to the
Occupational Safety and Health Administration's (OSHA) ergonomics
standard. As you are aware, the Congressional Review Act of 1996 gives
Congress the authority to vitiate this standard and permanently prevent
OSHA from promulgating a rule in substantially the same form.
Let me assure you that, in the event a Joint Resolution of
Disapproval becomes law, I intend to pursue a comprehensive approach to
ergonomics, which may include new rulemaking, that addresses the
concerns levied against the current standard. This approach will
provide employers with achievable measures that protect their employees
before injuries occur. Repetitive stress injuries in the workplace are
an important problem. I recognize this critical challenge and want you
to understand that the safety and health of our nation's workforce will
always be a priority during my tenure as Secretary.
I look forward to working with you throughout the entire 107th
Congress.
Sincerely,
Elaine L. Chao,
Secretary of Labor.
SUBCOMMITTEE RECESS
Senator Specter. Thank you very much, Mr. Woodward. Thank
you, Mr. Fellner. Thank you, Ms. Rhinehart.
Thank you very much, that concludes the hearing. The
subcommittee will stand in recess until 9 a.m., Wednesday,
April 25, when we will meet in room SD-192 to hear from HHS
Secretary Thompson.
[Whereupon, at 12:15 p.m., Thursday, March 6, the
subcommittee was recessed, to reconvene at 9 a.m., Wednesday,
April 25.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002
----------
WEDNESDAY, APRIL 25, 2001
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Stevens, Specter, Harkin, Kohl, Murray,
and Landrieu.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF TOMMY G. THOMPSON, SECRETARY OF HEALTH AND
HUMAN SERVICES
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. This meeting of the Subcommittee for
Labor, Health, Human Services and Education will now convene.
We are pleased to have the distinguished Secretary of the
Department of Health and Human Services, former Governor of
Wisconsin, the Honorable Tommy Thompson. This is your first
appearance before our subcommittee on a formal basis, but both
Senator Harkin, the distinguished ranking member, and I have
had opportunities to meet with you and talk about priorities,
your plans, and our inputs into the very very important
Department which you are heading.
The Department has discretionary funding under the
administration's budget this year for $51.5 billion, which is
approximately $2.5 billion above the fiscal year discretionary
allowance for the year we are in now. There are a great many
very, very, important programs which your Department is
administering. You have come up with increases in some very
important areas, and there have been some decreases in some
important areas which we will want to discuss with you.
In the interest of time, I am going to ask that my full
statement be included in the record. As I told the Governor
yesterday and again this morning, these days are all busy, and
we appreciate you coming over early for a 9 a.m. session. The
judiciary committee has a session at 10 a.m., which I expect to
Chair shortly after it is convened for Senator Hatch, and I
know Senator Harkin has commitments, so we will move right
along. I am now delighted to yield to my partner, Senator Tom
Harkin.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Thank you very much, Mr. Chairman, and
again, it is always a pleasure to work with you in your
capacity as chairman of this very important subcommittee. It is
my pleasure also to welcome Secretary Thompson today to testify
about the 2002 budget.
First of all, Mr. Secretary, I am pleased to see that both
NIH and community health centers have received significant
increases in the budget. Kudos to you and to the President for
that.
I am also glad that you have continued funding for the
construction of new laboratories at the Center for Disease
Control and Prevention, Atlanta. I understand you visited there
yourself and saw how important this work is and how those old
buildings need to be upgraded----
Secretary Thompson. Thank you very much, Senator.
Senator Harkin. So I am really happy that you did that.
I am also encouraged that the administration has shown
strong support for the real choice system change grants by
including them in the President's new freedom initiative for
people with disabilities. The chairman and I worked hard to
include funds for these grants in last year's bill, and we look
forward to working with you on this and other Medicaid reforms
that will allow people with disabilities and the elderly to
live at home in the community.
I might just paraphrase as an aside here, Mr. Secretary,
when the President came and met with the Democratic caucus, we
had a Democratic group meeting here a month or two ago or
something, and he came and visited us. He said that money ought
to follow an individual, not a program. You ought to focus on
the individual, and the President is right on that.
When it comes to people with disabilities, that the money--
--
Secretary Thompson. That's true.
Senator Harkin [continuing]. Ought to follow the person
with the disability rather than a program, and if the person
wants to live in the community, they ought to be able to do
that. And so I said, we need some changes in Medicaid. He took
notes on that, so I know that it registered with him. I am glad
to see that you are continuing this program and hopefully we
will be able to help get the funds for it.
On a little other down note, though, I am disappointed that
there are some other public health programs and a number of
programs for children that did not fare as well, Mr. Secretary.
A few weeks ago on the budget debate, Senator Specter and I
worked on an amendment that was passed, that shifted money from
the tax cut, mostly to education, but there was also money in
there to make sure that kids could get ready to learn.
In 1989, President Bush, then Governor Bush and the
Nation's Governors met in Charlottesville, West Virginia.
Secretary Thompson. That is correct.
Senator Harkin. And they came up with some national goals
for schools, education. The first goal was that every child
should be ready and able to learn by the year 2000. Last year
has come and gone and we have not gotten there. Well, I do not
think that we ought to give up on it, we ought to just recommit
ourselves to it. So I guess what I'm talking about is Head
Start, an early learning fund, and quality child care, programs
that come under your purview at your department. There were
monies in the amendment to fully fund the Head Start program,
and to fund the early learning fund at the authorized level.
Now I have got to tell you that I am disappointed that the
budget eliminates the early learning fund, and I hope we can
work to get that back in, Mr. Secretary.
The budget also cuts child care funding for infants and
toddlers, and there is no expansion for Head Start. Now I am
not going to say that this is absolutely certain, but from our
initial read of the Head Start funding for next year, it looks
as though about 2,500 kids are going to be cut out of Head
Start under the budget. Now, if I am wrong, I would like to be
proven wrong on that, but from the initial run that we have
seen on that, with all of the quality programs and stuff built
in there, the discretionary money that is left over will
actually serve 2,500 kids less next year.
Take a look at that please. I am not certain that is true,
but that is the first kind of run we took. If that is the
direction we are going, we have to do more under your purview
on that.
So these are priorities that I hope to work with you and
other members of the subcommittee on, to do.
Now, one last note, Mr. Secretary.
Secretary Thompson. Yes.
Senator Harkin. In Iowa and in Wisconsin and in a lot of
other States, our people are paying as much in for Medicare as
any other State in the Nation, but what we get back, our
reimbursement rate in Iowa is $2,900, and in Louisiana it is
$7,000. I do not know where Alaska falls, but I bet it is down
there somewhere.
And so, what I am saying, there is such a huge disparity in
our reimbursement rates, I think Wisconsin is probably right
down there with us someplace too, I think, so it is unfair to
seniors in Iowa and those who live in rural States. If we just
looked at the average for the United States and take where Iowa
is in that average, we are losing a billion dollars a year that
we have by rights coming in to take care of our elderly.
Secretary Thompson. Senator, when I was Governor of
Wisconsin, I would have changed our reimbursement rate for
Iowa. We got treated even worse.
Senator Harkin. You were worse than Iowa? Well, we are next
to last, and I know you are not the last now, so you must be up
above us somewhere right now, but you know what I am talking
about.
Secretary Thompson. I know.
Senator Harkin. And we are going to introduce legislation
to address this and try to get a better national average, and I
hope to work with you on this issue. Thank you, Mr. Secretary.
Secretary Thompson. Thank you, Senator.
Senator Specter. Thank you very much, Senator Harkin. We
are joined today by our distinguished chairman of the full
committee, Senator Stevens.
OPENING STATEMENT OF SENATOR TED STEVENS
Senator Stevens. Thank you very much, Mr. Chairman. Mr.
Secretary, we are delighted you are taking on this task and
with your background we are even more delighted, because we
know what you have done in your own State. I am really pleased
that you have stopped by to visit me, and I am sure you are
visiting everyone else to talk over the future of your area.
I want you to know that I am concerned about the progress
of keeping our commitment to double NIH funding. I really
commend Senator Specter and Senator Harkin for their initiative
in carrying this forward. Baby boomers are coming at us fast
and if we do not get this science completed in order to deal
with their problems in a different way than we have dealt with
our generation, I think it is going to be extremely costly for
the United States. The investment that we are going to make in
health care research I think will pay off great dividends.
I do support your efforts and the administration's
efforts--I think Senator Bond has been the leader up here on
this concept--to double funding for community health centers.
However, I have to tell you that until this year, my state
received only $7 million out of the total of $1.1 billion for
community health centers. I found that the authorizing
legislation and the regulations in your department hinder
smaller rural isolated communities like those we have in our
state from participating in that program. I hope that the
community health center legislation that we develop to
reauthorize this program will eliminate those barriers to the
participation of frontier communities in America in the
community health center program.
Your budget eliminates the funding for what we call our
Denali Commission, to build clinics in remote Bush communities
in Alaska. There are 271 of those, Mr. Secretary. I hope to get
you up to see our state soon, not just to the capital and our
major city, but out to the Hooper Bays and the Scammon Bays,
and the various areas that have tremendous problems.
Forty percent of the 271 native villages do not have water
and sewer systems. And these are communities that have no tax
base, they are completely surrounded by federal property. They
have unemployment rates in excess of 80 percent on a structural
basis. There is no way that they can develop their own funds
for health services.
We developed the Denali commission so it could handle funds
from several different agencies, merge them together, and do a
comprehensive development in each village, instead of going
into one village with water and sewer one year, and into
another one the next year, and having different concepts coming
in from HUD or from EPA. We have tried to put them all together
so that when they go to the village, they do a comprehensive
job that is less expensive and more productive in terms of
producing good benefits.
It is one of the things I hope you really look at, because
we put an overhead ceiling of 5 percent on the Denali
commission. The overhead at your department is 30-plus percent
on monies that go to rural areas. There is just no reason to
handle money that way, particularly when several departments
are needed to deal with the problems of one single small rural
village.
I think if you take the time to come up, we can show you
how you can be of great help and save money in the long run.
The one really sad thing I want to discuss with you, and
Senator Harkin has already mentioned that, and that's the
initiative I developed which was called the Early Learning
initiative. Your budget eliminates $20 million for that. It is
not a lot of money, and I do support the first lady's reading
program. There is no reason not to have them both.
But the early learning initiative is a comprehensive
approach to preparing children for school and I think it is
absolutely essential in these times. We listened to the
Secretary of Education yesterday concerning the problems of
reading throughout the country, and it seems that no matter how
much money we put into the Department of Education, the reading
levels are not going up. This is one small amount that will, we
believe, bring those reading skills up more rapidly than much
of the billions of dollars that have been spent in the past, so
I urge you to take a look at that.
But again, I welcome you and look forward to working with
you, and I am sure that it is going to be an interesting time
for you. I appreciate your service. Thank you very much.
Secretary Thompson. Thank you very much, Senator Stevens.
Senator Specter. Thank you very much, Senator Stevens.
Our practice, Mr. Secretary, is to put your full statement
in the record and ask you to hit the highlights and summarize
it as you see fit, so the floor is yours.
Secretary Thompson. Senator Stevens, before you leave, I
would just like to say thank you, and I will be looking forward
to traveling to Alaska this summer and discussing it with you,
and I hope to be working with you on the Denali Commission.
Senator Stevens. Let me see if I can develop some of your
other skills.
Summary statement of Hon. Tommy G. Thompson
Secretary Thompson. I am not very good at it but I will
certainly try, and if the chairman asks me to do it, I will do
it.
Good morning, Chairman Specter, and thank you for your kind
introduction and your friendship for many years and I
appreciate that. And Senator Harkin, thank you for doing the
wonderful job you do in the neighboring State of my home State.
I have watched you with a great deal of interest and support
for many years, and I apologize to you for not being able to
get to see you personally, but I will be making every attempt
to do so very quickly. I want to meet all the Senators in their
office, and I look forward to that.
I am honored, Senators, to appear before you today to
discuss the President's fiscal year 2002 budget for the
Department of Health and Human Services. I will make this very
short, because I know both of you have to leave and I know you
want to ask questions and I want to answer them.
But several weeks ago I appeared before the colleagues of
the Senate Budget Committee to discuss the President's fiscal
year 2002 budget framework. Since that time, much has been
written and said about selected portions of our budget. Some
unfair and some inaccurate charges have been leveled against
it. That is why I am so very pleased today to have this
opportunity to appear before you to discuss our detailed budget
proposal. I am confident that a review of the full details of
our budget will demonstrate that we are proposing a balanced
responsible approach to building a strong and healthy America.
The budget before you today keeps the promises the
President has made. It proposes new and innovative solutions
for meeting the challenges that face the nation. Our proposal
increases support for America's children and families, enhances
the ground breaking research being sponsored by the National
Institutes of Health, and I want to thank both senators for
being so supportive of the NIH.
Again, the modernization of Medicare expands access to
health care and reforms the way the department operations are
managed. Mr. Chairman, the total HHS request for fiscal year
2002 is $468 billion. The discretionary component totals $55.5
billion, and the amount before this committee totals $300
billion in budget authority, of which $52 billion is
discretionary.
I know, Mr. Chairman, you have been very interested in NIH,
as I have. I want to tell you that there is just some wonderful
things going on up at NIH. And as you know, and you have been
up there several times, and we are so close in so many areas,
it is truly an exciting time to be Secretary of this Department
and be involved.
Senator Harkin, I appreciate your support of CDC. I have
been down there. I do not know if you know this, but we are
currently renting 22 buildings all over the city of Atlanta. I
went down there and looked at it, and it is a crazy way to run
it. We have land there, we have got an opportunity to build
something that everybody in America can be proud of. And I
pushed very hard to get the money of $150 million for new
laboratories there. I would like to consolidate the 22 areas
into one beautiful college campus that is going to do the
things necessary for CDC, and I appreciate your support.
Senator Harkin. I will back you any way I can.
Secretary Thompson. I know that, and I appreciate that.
In regards to women's health, we have put in a great deal
of additional money for women's health because it is so
important. We also have put a lot of money into children.
PREPARED STATEMENT
I could go on, but I think I would much rather stop at this
time, Senators, and Senator Murray, it is a pleasure to be in
front of you as well. I know you have lots of questions, and I
would just as soon answer your questions, and I will leave the
rest of my written remarks for you to put in the record if that
would be okay.
Senator Specter. That is fine, Mr. Secretary. We appreciate
that.
[The statement follows:]
Prepared Statement of Hon. Tommy G. Thompson
Good Morning, Chairman Specter, Senator Harkin, and members of the
Subcommittee. I am honored to appear before you today to discuss the
President's fiscal year 2002 budget for the Department of Health and
Human Services.
Several weeks ago, I appeared before your colleagues on the Senate
Budget Committee to discuss the President's fiscal year 2002 budget
framework. Since that time, much has been written and said about
selected portions of our budget, and some unfair and inaccurate charges
have been leveled against it. This is why I am so pleased to have the
opportunity to appear here today to discuss our detailed budget
proposal. I am confident that a review of the full details of our
budget--not selected pieces of it--will demonstrate to one and all that
we are proposing a balanced, responsible approach to building a strong
and healthy America.
Part of this approach involves taking another look at the way we do
things on the national level. We must no longer be content to do things
a certain way because ``that's how we've always done it''; but must
instead be willing to reform our business practices and seek innovative
ways to manage our programs. And while we know that the Federal
Government has an important role to play, we must also recognize that
we must look to others--to State, local, and tribal governments, to
community and faith-based organizations, to the private sector, and to
academic institutions--for new and creative approaches to solving
public problems. The President and I share this view, and I am proud to
say that it is manifested in the budget he has put forward.
The budget I present to you today keeps the promises the President
has made and proposes new and innovative solutions for meeting the
challenges that face the nation. Our proposal increases support for
America's children and families; enhances the groundbreaking research
being sponsored by the National Institutes of Health and protects
public health; begins the modernization of Medicare and expands access
to health care; and, invests in infrastructure and reforms the way the
Department's operations are managed. The HHS budget also reflects the
President's commitment to a balanced fiscal framework that puts
discretionary spending on a more reasonable and sustainable growth
path; protects Social Security, Medicare, and other priority programs;
continues to pay down the national debt; and, provides tax relief for
all Americans.
Mr. Chairman, the total HHS request for fiscal year 2002 is $468.8
billion (outlays). The discretionary component totals $55.5 billion
(budget authority). The amount before this Committee totals $300.7
billion in budget authority, of which $51.4 billion is discretionary.
Let me now discuss some of the highlights of the HHS budget.
increasing support for america's children and families
The HHS budget substantially increases our investment in children.
Overall, the President's budget provides nearly $3 billion in increased
spending for children's programs in this Department. The budget
includes both increases for existing programs and investments in a
number of new programs designed to fulfill President Bush's commitment
to making sure that no child is left behind. This administration
recognizes that America's children and families are its strength, and
this budget reflects our commitment to helping them thrive and prosper.
Our budget also increases support for the charitable organizations that
can make such a difference in people's lives.
After School Certificates
One of the lessons I learned during my years as Governor of
Wisconsin was that for people to move from dependency to success in the
workforce, you had to be willing to invest in programs that support
working families. One of the most important things that we as a
government can do to help working families is to assist them in
obtaining high-quality child care. Last year the Congress voted to
provide a substantial increase in child care funding, and this year we
are asking you to take another step to help working parents and their
children be successful. The President has requested a total of $2.2
billion for the Child Care and Development Block Grant and has proposed
to specifically dedicate $400 million for After School Certificates
within the block grant. These certificates would help low-income
working parents to pay for the costs of after school care for up to
500,000 children who are less than 19 years old. We expect these after
school activities to also have a strong educational component, helping
children to achieve success in school.
Promoting Safe and Stable Families and Independent Living
Our budget takes a number of steps to help protect our most
vulnerable and at-risk children and to help them live safe and
productive lives. First, we propose to create a new $67 million
discretionary program within the Promoting Safe and Stable Families
program to mentor children of prisoners. This initiative will provide
grants through States, to assist faith and community-based groups in
providing a range of activities to assist children of prisoners and
probationers, including family-rebuilding programs that will help to
reunite children and parents once the parent is released from prison if
it is in the best interests of the child. Our budget also proposes a
$200 million increase in mandatory funding for the Promoting Safe and
Stable Families program, which supports State and Tribal child welfare
agencies in carrying out family preservation and support services and
adoption promotion and support programs. We also propose an additional
$60 million for the Independent Living program. These funds would be
used to provide vouchers, worth up to $5,000, to youths who are aging
out of foster care so that they can obtain the education and training
they need to lead productive lives. Funds could be used to pay for
either college tuition or vocational training.
Maternity Group Homes
One of the toughest problems we face in trying to end the cycle of
dependency is children having children. These teenage mothers have
often suffered abuse or neglect and may not have a safe and supportive
family environment in which to raise their babies. To begin removing
the obstacles to success that these mothers and their children face, we
are proposing $33 million for a new Maternity Group Homes program. This
program will support efforts to work with organizations that operate
community-based, adult-supervised group homes for teenage mothers and
their children, as well as to provide certificates to young mothers to
obtain supportive services. These homes will provide a safe and
nurturing environment for young mothers while offering the support
necessary to help them and their children to improve their lives.
Promoting Responsible Fatherhood
Helping young mothers is an important part of our program to assist
America's families, but it is also important that we recognize the
critical role that fathers play in the lives of their families. The
unfortunate reality is that nearly 25 million children do not live with
their fathers, and studies show that these children are far more likely
to experience poverty and suffer problems in school than children who
live with both parents. Our budget framework includes $64 million to
begin an initiative to promote responsible fatherhood by providing
competitive grants to faith-based and community-based organizations
that work to strengthen the role that fathers play in their families'
lives. These funds will be used to support programs that help low-
income and unemployed fathers and their families to avoid dependence on
welfare, and to fund programs that promote successful parenting and
marriage. Of these funds, $4 million will be used for special projects
of national significance.
Compassion and Charitable Giving
The President has been a leader in recognizing the important role
that charitable organizations play in delivering services to the
public, and we are proposing a number of steps to increase Federal
support for these groups. First, we are requesting $89 million to
establish a Compassion Capital Fund. Through public and private
partnerships, these resources will be used to provide start-up capital
and operating funds to qualified charitable organizations so that they
can expand or emulate model social services programs. Funds will also
support research on ``best practices'' among charitable organizations.
Our budget also includes $3 million to establish a Center for Faith-
Based and Community Initiatives in the Department in accordance with
the President's recent Executive Order. Finally, we have included a
proposal to encourage States to provide tax credits for contributions
to designated charities that work to address poverty. Under this
proposal, States would be allowed to use Federal funds provided through
the Temporary Assistance for Needy Families program to partially offset
revenue losses that resulted from the tax credits.
Head Start
Head Start is the Nation's largest early childhood education
program. The Head Start program helps to ensure that low-income
children start school ready to learn and, to that end, provides a range
of comprehensive child development and health services. The President
proposes to revitalize Head Start by making school readiness skills
such as pre-reading and numeracy the program's top priorities. For
fiscal year 2002, the budget proposes a total of $6.3 billion for Head
Start, an increase of $125 million. These funds will allow Head Start
to serve 916,000 children, including 55,000 in Early Head Start, and to
maintain a competitive salary for teachers.
ENHANCING SCIENTIFIC AND HEALTH CARE QUALITY RESEARCH
Advances in scientific knowledge have provided the foundation for
improvements in public health and have led to enhanced health and
quality of life for all Americans. Our fiscal year 2002 budget enhances
support for scientific research as well as for research to improve the
quality of the Nation's health care system.
Biomedical Research Sponsored by the National Institutes of Health
The National Institutes of Health (NIH) is the largest and most
distinguished biomedical research organization in the world. The
research that is conducted and supported by the NIH, from the most
basic research on biological systems to the successful mapping of the
human genome, offers the promise of breakthroughs in preventing and
treating any number of diseases. A top priority for this Administration
is ensuring that the NIH continues to have the resources necessary to
help turn these promises into a reality.
This budget keeps the President's commitment to double NIH's fiscal
year 1998 funding level by fiscal year 2003. For fiscal year 2002, we
are proposing an increase of $2.75 billion, which will be the largest
dollar increase ever for NIH. This funding level will enable NIH to
support over 34,000 research project grants, the highest level in the
agency's history. NIH will expand its focus on four research areas that
show the greatest potential for yielding new scientific breakthroughs:
genetic medicine, clinical research, interdisciplinary research, and
health disparities.
With any large increase in resources, there also comes the
increased challenge of making sure that those resources are managed
properly. I take this responsibility very seriously, and NIH will be
working to develop strategies to ensure that we are managing taxpayer
dollars in the most efficient and effective way.
Patient Safety and Health Care Quality
The Agency for Healthcare Research and Quality (AHRQ) is the
Federal agency with primary responsibility for research on the Nation's
health care system and is HHS's lead agency for improving patient
safety and the quality of everyday health care. The fiscal year 2002
budget provides a total program level of $306 million for AHRQ, an
increase of $36 million or 13.5 percent over fiscal year 2001.
AHRQ will devote a total of $53 million to continue the work this
Committee first funded in fiscal year 2001 to identify ways to reduce
medical errors. These funds will support activities to research the
causes of medical errors, develop and test new technologies to reduce
medical errors, test reporting strategies, and improve training.
Earlier this week, I announced the establishment of a new Patient
Safety Task Force within the Department in which AHRQ will collaborate
with FDA, CDC, and HCFA to improve existing reporting systems on
patient safety. HHS seeks to develop a robust, anonymous database of
information on errors and adverse events that can be used to find new
and better ways to improve patient safety.
Our request includes a $26 million increase for research on health
care quality and cost-effectiveness. Like you and many others, we are
reviewing the recent recommendations by the Institute of Medicine for
research to improve the quality of health care. Once that review is
complete, I expect that an appropriate portion of these resources will
be directed toward the recommendations that we conclude should be given
the highest priority. I also expect the findings of this and other
research on patient safety, which have emphasized the importance of
encouraging and rewarding the development of health care systems that
encourage safer and higher-quality care, to guide our efforts to
improve Medicare, Medicaid, and other government health programs.
IMPROVING MEDICARE AND EXPANDING ACCESS TO QUALITY HEALTH CARE
Of all the issues confronting this Department, none has a more
direct effect on the well-being of our citizens than the quality of
health care. Our budget proposes to improve the health of the American
people by taking important steps to improve Medicare, including the
addition of a prescription drug benefit, and by directing funds to
various initiatives aimed at expanding access to health care.
Modernizing Medicare
The Medicare program has been the center of our society's
commitment for ensuring that all of our seniors enjoy a healthy and
secure retirement. Honoring this commitment means not only making sure
that the program is financially prepared for the wave of new
beneficiaries that the aging of the baby-boom generation will bring,
but also ensuring that current beneficiaries have access to the highest
quality care. As an interim step, the President has put forward an
Immediate Helping Hand (IHH) prescription drug proposal. This proposal
provides $46 billion over 5 years to help States provide prescription
drug coverage immediately to beneficiaries with limited incomes or high
drug expenses. This proposal, which will sunset in fiscal year 2005 or
as soon as legislation to strengthen Medicare including a prescription
drug benefit is enacted, would provide immediate coverage for up to 9.5
million beneficiaries.
We also believe, along with many members of Congress who have
supported and continue to support bipartisan efforts to strengthen
Medicare, that we must take steps to improve Medicare as soon as
possible. Inadequate prescription drug coverage is only the most
obvious gap in Medicare benefits. Today, Medicare covers only 53
percent of the average senior's annual medical expenses, and the
options available to seniors to help them limit these expenditures are
declining. In addition, Medicare is facing a looming fiscal crisis. A
full assessment of the health of both the Part A and Part B Trust Funds
reveals that spending exceeds the total of tax receipts and premiums
dedicated to Medicare and that financing gap is expected to widen
dramatically. Even without the financing problem, Medicare
modernization would be necessary to ensure beneficiaries get high
quality health care. President Bush proposes to devote $156 billion
(including funding for Immediate Helping Hand) over the next 10 years
to a set of improvements in Medicare that are urgently needed. These
Medicare modernizations include taking steps to make better coverage
options available, to assure that all seniors have affordable access to
prescription drugs, to provide better options for high out-of-pocket
expenses, particularly for low-income seniors, and to ensure that
Medicare has greater overall financial security.
Expanding Community Health Centers
Our budget also proposes steps to strengthen the health care safety
net for those most in need. Community Health Centers provide high
quality, community based care to approximately 11 million patients, 4.4
million of whom are uninsured, through a network of over 3,000 centers
in rural and urban areas. The President has proposed to expand and
increase the number of health center sites by 1,200 by fiscal year
2006, and to double the number of individuals without alternative
coverage who are served by the centers. As a first installment of this
multi-year initiative, we propose to increase funding for Community
Health Centers by $124 million. We will also be looking at ways to
reform the National Health Service Corps so as to better target
placement of providers in areas experiencing the greatest shortages of
health professionals.
Increasing Access to Drug Treatment
The problems caused by substance abuse affect not only the physical
and mental condition of the individual, but also the well-being of
society as a whole. Nationwide, approximately 2.9 million people with
serious substance abuse problems are not receiving the treatment they
desperately need. To help close this treatment gap, we propose to
increase funding for substance abuse treatment by $100 million. Of
these funds, $60 million will be used to increase the Substance Abuse
Block Grant, the primary vehicle for funding State substance abuse
efforts, and $40 million will go to increase the number of Targeted
Capacity Expansion grants, which seek to address the treatment gap by
supporting strategic and rapid responses to emerging areas of need,
including grants to organizations that provide residential treatment to
teenagers.
Organ Donation
Our budget supports an initiative very close to my heart.
Approximately 75,000 patients are awaiting organ transplants, far above
the number of available donors. In fact, organ transplants in 2000
totaled 22,827, an increase of 1,172 over the 21,655 transplants that
occurred in 1999. The number of living donors rose from 4,747 in 1999
to 5,532 in 2000, an increase of 16.5 percent, the largest 1-year jump
ever recorded. While I am encouraged by the progress that has been made
in the last year, there is still a very long way to go. To tackle this
problem, I launched a new national initiative, on April 17th, to
encourage and enable Americans to ``Donate the Gift of Life''. I am
beginning a national ``Workplace Partnership for Life'', in which
employers, unions and other employee organizations can join in a
nationwide network to promote donation. I released a model organ and
tissue donor card, incorporating proven elements from today's donor
cards and have ordered an immediate review of the potential of organ
and tissue registries where donors' wishes could be recorded
electronically and made available to families and hospitals when
needed. I have also made a pledge to create a national medal to honor
the families of organ donors and will create a model curriculum on
donation for use in driver education courses, to be offered to states
and counties nationwide. And, let me tell you, this is just the
beginning. I intend to do everything I can to increase organ donation
throughout America and to create the most comprehensive effort ever in
our nation regarding donation and transplantation.
INVESTING IN INFRASTRUCTURE AND REFORMING MANAGEMENT
For any organization to succeed, it must never stop asking how it
can do things better, and I am committed to seeking new and innovative
ways to improve the management of our programs. But we must also
recognize that we do a disservice to all who rely on this Department if
we do not provide the resources necessary to effectively administer our
programs. In preparing our budget, we began the process of evaluating
the programs and business practices of this Department and identifying
the areas where we can do a better job of managing taxpayer resources,
as well as those areas where new investments are required if we are to
successfully administer our operations.
HCFA Management Reform
One of the most important management reforms we will pursue is the
improvement of the Health Care Financing Administration (HCFA). I have
often referred to HCFA as the agency people love to hate; and I
recognize that patients, providers, and States have legitimate
complaints about the scope and complexity of the regulations and
paperwork that govern the Medicare, Medicaid, and State Children's
Health Insurance programs. At the same time, we must recognize that in
the last few years HCFA has been tasked with implementing several
pieces of major legislation and its responsibilities have grown more
complex with each new major healthcare law or budget reconciliation.
Concerns about HCFA's management capabilities have been raised in
several General Accounting Office reports, including the High Risk
Series: An Update (January 2001) and Financial Management: Billion in
Improper Payments Continue to Require Attention (October 2000). HCFA
management reform is an Administration priority. HCFA will undertake a
major effort to modernize and streamline its operations to effectively
manage current programs and implement new legislation. In particular,
HCFA's role in a modernized Medicare program needs to be carefully
considered. This may require substantial changes in HCFA's mission and
structure. My goal is to assure that HCFA's resources are focused as
effectively as possible on improving quality and limiting costs for
Medicare beneficiaries, limiting burden for providers, and increasing
efficiency for taxpayers.
The budget proposes an increase of $109 million, or 5 percent, for
HCFA program management. Included in the HCFA program management budget
is an increase of $36 million, for a total of $53 million, to support
the development of the HCFA Integrated General Ledger Accounting System
(HIGLAS). HCFA currently relies on several financial management systems
to account for the hundreds of billions of dollars spent on Medicare
benefits, and most contractors do not use double entry accounting
methods or claims processing systems with general ledger capabilities.
This system requires financial statements to be imputed manually,
increasing the risk of administrative and operational errors and
misstatements. HIGLAS will provide a uniform Medicare accounting system
that will help to detect and collect money owed to the Medicare Trust
Funds, retain a clean opinion on financial statements without more
expensive, alternative efforts, and comply with financial management
statutory requirements.
I am also committed to reforming HCFA's antiquated and inefficient
contracting system. We are considering a number of options in this area
including: allowing carriers who are not health insurance organizations
to become Medicare contractors; allowing the Secretary (as opposed to
the Part A provider) to contract for and assign fiscal intermediaries
to perform claims processing, claims payment, communications, audit
functions, renewing contracts, and transferring functions; and
replacing current special provisions for terminating contracts with
more standard terms and conditions embodied in the Federal Acquisition
Regulation (FAR). In addition, I am including in the budget $115
million in new proposed user fees for duplicate and paper claims
processing. We will work hard to enact these fees, which will help to
improve the efficiency and lower the cost of processing Medicare
claims.
Revitalizing Laboratories and Scientific Facilities
It is critical that we invest in the modernization of the
laboratories and scientific facilities, for obsolete facilities affect
our scientific readiness and compromise our ability to retain the top
scientists. Our budget includes funds to continue the revitalization of
key facilities at the Centers for Disease Control and Prevention and
the National Institutes of Health. We are requesting $150 million for
buildings and facilities at the Centers for Disease Control and
Prevention, which will support construction of a laboratory facility
dedicated to handling the most highly infectious pathogens, such as
Ebola, and construction of an Environmental Toxicology Lab. The budget
also requests $307 million for intramural buildings and facilities at
the National Institutes of Health to support projects such as the
construction of the John Edward Porter Neuroscience Research Center and
a centralized, multi-level animal facility.
Enhancing Coordination and Reducing Duplication of Operating Systems
The only way that this Department can effectively serve its many
clients is if we commit to making the necessary investments in our
management and infrastructure. One of the challenges in a large,
decentralized Department such as HHS is finding ways to bring together
diverse activities and to develop coordinated systems for managing our
programs. Our budget provides the resources necessary to begin the
process of streamlining our financial management and information
technology systems so that we can enhance coordination across the
Department and eliminate unnecessary and duplicate systems.
For financial management, we propose to invest $50 million, which
includes funding for the new HCFA accounting system, to move toward a
unified financial accounting system. The Office of Inspector General
has cited problems with the Department's current system structure,
which involves five separate accounting systems operated by multiple
agencies. We plan to replace these antiquated systems with unified
financial management systems that will increase standardization, reduce
security risks, allow HHS to produce timely and reliable financial
information needed for management decision-making, and provide
accountability to our external customers.
In the information technology arena, we are proposing $30 million
for a new Information Technology Security and Innovation fund.
Currently, the Department's information technology systems are highly
decentralized, heterogeneous, and vulnerable to exploitation. Funds
would be used to implement an Enterprise Infrastructure Management
approach across the Department that would minimize our vulnerabilities
and maximize our cost savings and ability to share information. With
this approach, we will be able to reduce duplication of equipment and
services and be better able to secure our systems against viruses and
network intrusion.
As the largest grant-making agency in the Federal Government, this
Department will also continue to play a lead role in the government-
wide effort to streamline, simplify, and provide electronic options for
the grants management processes. As part of the Federal Grant
Streamlining Program, we will work with our colleagues across the
government to identify unnecessary redundancies and duplication in the
more than 600 Federal grant programs and to implement electronic
options for all grant recipients who would prefer to apply for,
receive, and close out their Federal grant electronically.
Redirecting Resources and Enhancing Flexibility
Being a wise steward of taxpayer resources means not only
recognizing where you need to invest but also where resources can be
redeployed to more effective uses. In preparing our budget, we
carefully reviewed each agency, identified areas where funding could be
redirected, and made targeted reductions in selected programs. The
fiscal year 2002 budget eliminates $475 million in earmarked projects
and $155 million in funding for activities that were funded for the
first time in fiscal year 2001. In addition, the budget shifts $597
million from programs that are duplicative, or whose goals are better
met through other avenues, to higher priority activities. And, to
assist in financing other high priority activities, the budget expands
the use of Public Health Service Evaluation funds. These decisions
helped to meet our goal of moderating the large increases in
discretionary spending that have occurred over the last few years and
putting the budget on a more sustainable growth path for the future.
This Administration is also committed to giving States greater
flexibility to manage public health grant programs. Our budget proposes
to give States expanded authority to transfer funds among public health
grants, thereby enabling them to make more efficient and effective use
of Federal resources and to target and reallocate funds to public
health priorities identified at the State and local levels.
In addition to giving the States greater flexibility, I am seeking
to increase my transfer authority from one percent to six percent, to
eliminate the restriction that the transfer may not increase an
appropriation by more than three percent, and to make it Department-
wide. I believe this transfer authority is a valuable tool for managing
the Department's resources and will allow me to respond to emergency
needs or unforeseen events that would otherwise adversely effect a
program or agency.
Continuously Evaluating and Improving Program Performance
The Government Performance and Results Act serves as an important
tool for making sure that this Department is not only doing the right
things but that we are doing them well. As in previous years, our
budget request is accompanied by the annual performance plans and
reports. The performance measures and targets in these reports touch
nearly every aspect of the Department's multi-faceted mission and
detail a number of notable achievements, including:
--HCFA met its fiscal year 2000 target of reducing the Medicare error
rate to 7 percent.
Auditors estimated improper payments at $11.9 billion, compared
with $13.5 billion in fiscal year 1999. The error rate has
fallen to roughly half of what it was in fiscal year 1996, and
HCFA is pursuing increasingly rigorous goals for fiscal year
2001 and fiscal year 2002.
--The Administration for Children and Families (ACF) reported that
42.9 percent of adult recipients of TANF became employed in
fiscal year 1999. This is a primary indicator of success in
moving families toward self-sufficiency. It improves on the
fiscal year 1998 baseline of 38.7 percent and exceeds the
target of 42 percent.
--CDC reported a reduction of perinatal Group B streptococcal
disease--the most common cause of severe infections in
newborns--by 70 percent from 1995 to 1999, exceeding the goal.
These are just a few of the dozens of impressive success stories
found in the 13 performance plans and reports. GPRA has been and will
continue to be an important part of our effort to improve the
management and performance of our programs.
WORKING TOGETHER TO BUILD A STRONG AND HEALTHY AMERICA
Mr. Chairman, the budget I bring before you today contains many
different proposals; but, the common thread that binds them all
together is the desire to build a strong and healthy America and to
improve the lives of the American people. All of our proposals, from
enhancing scientific research to modernizing Medicare, from expanding
access to care to increasing support for the Nation's children and
families, are put forward with these simple goals in mind. I know these
are goals we all share.
As you begin to consider our proposals, let me leave you with one
final thought. Senator Everett Dirksen said of the legislative process:
``You start from the broad premise that all of us have a common duty to
the country to perform. Legislation is always the art of the possible.
You could, of course, follow a course of solid opposition, of
stalemate, but that is not in the interest of the country.'' Starting
from this premise, I am prepared to work with each of you to ensure
that we develop a budget for this Department that effectively serves
the national interest. I would be happy to address any questions you
may have.
CENTERS FOR DISEASE CONTROL PREVENTION
Senator Specter. As is our practice, we will commence with
5-minute rounds for each Senator.
I begin, Mr. Secretary, with the issue of the Centers for
Disease Control. The Centers have deteriorated just
tremendously, and it is a matter of some concern to me that
there had not been action by the last administration and a very
competent Secretary of Health and Human Services in alerting
this subcommittee to the deplorable conditions. I made a trip
down there about a year ago, and this subcommittee took the
lead in putting in $170 million because the situation was so
catastrophic.
My recent meeting with the representatives of the Center
found that they want $240 million. You have----
Secretary Thompson. $150 million.
Senator Specter [continuing]. $150 million, which is $25
million down from our figure last year. And my question to you
is, how do you calculate $150 million, and is that really
enough, or are the people at the Center really on the right
track in asking for about $240 million?
Secretary Thompson. Well, I think you can make that
argument, Senator, but the truth of the matter is, there are 22
buildings that we're renting, and I think it makes very good
fiscal sense as well as scientific sense to be able to
consolidate those into one campus.
Senator Specter. I went down there, and there is no doubt
about the consolidation. Let me ask you to do this. Let me ask
you to have your department take a look at the overall program,
which is a big one, in excess of a billion dollars as I
understand it, and give us a projection as to what we are going
to have to spend next year, the year after, so that we can make
an evaluation of priorities as to whether we think we need to
shift some money.
Secretary Thompson. Okay. Well, Senator, I have already
done that, and that is why we put in $150 million. It is going
to have to be an ongoing $150 million in order to modernize and
do it correct. If you want to accelerate it, you could do it at
$175 million. We cut back on some planning for the next
building and we felt we could do that in the next fiscal year,
and we put some labs and so on in this year.
Senator Specter. Let us take a look at your specific
projections and compare that with what the Center has in mind.
Secretary Thompson. Fine.
Senator Specter. And with what the other advocates have in
mind.
Secretary Thompson. My projections are not much different
than the Center's.
Senator Specter. Well, the figures are a fair amount lower,
but let us take a look at the specifics.
Secretary Thompson. Absolutely.
STEM CELL RESEARCH
Senator Specter. There is not a whole lot of time, so let
me move to the issue of stem cells, which is a very important
topic, and note just very briefly for the record that when this
issue broke in November of 1998, this subcommittee had a
hearing within a couple of weeks. We have had seven hearings on
the subject and I think it is a fair assessment that the
subcommittee, I know that Senator Harkin and I are convinced
that the stem cells which come from embryos are vital for
medical research.
A point which I think has to be emphasized, and you and I
have talked about this informally but just a word or two on the
record, is that these embryos are created for in vitro
fertilization, there are more created than necessary, and they
are going to be discarded. If there were any possibility that
these embryos would turn into human life, I would be the last
to countenance using them for stem cells. But when they are
going to be destroyed, then the alternative is to use them or
lose them, in effect.
I know that there is another evaluation of the legal
opinion issued by general counsel for the Department of Health
and Human Services, which concluded that Federal funds may be
used for research on the stem cells, once they are extracted,
but Federal funds may not be used to extract the stem cells
from the embryos. And speaking as one lawyer to another,
lawyers' opinions are not too hard to obtain on any given
proposition.
My yellow light is up and so I will conclude the issue by
asking you for your perspective and what your plans are on
handling this stem cell matter.
Secretary Thompson. Thank you very much, Senator. You know
this is a very contentious issue and one in which I have been
very much involved in from my prior life as the Governor of the
State of Wisconsin.
Stem cells are being evaluated by the Department, both by
the general counsel, and other legal opinions are being
discussed, but also scientific review is being done by NIH.
Both of those reviews will be to me, hopefully, by the first
week in June. And as regards to the process that is already in
place, there are two applications, and those applications are
being reviewed, even if the hearing was not postponed in April,
they would not have been able to be funded until next April.
That still is possible, if in fact both reviews come back
consistent with your point of view, or if in fact Congress
decides to change the law, Senator.
Senator Specter. My red light is on, so we turn now to
Senator Harkin.
REGULATION OF TOBACCO BY FDA
Senator Harkin. Thank you very much, Mr. Chairman.
Mr. Secretary, I have been pleased to hear your comments
about the need for FDA to regulate tobacco. Stick with it.
Secretary Thompson. I notice when I looked around, there
were not too many people behind me, except you, Senator.
Senator Harkin. Well, stay out there, you are right on that
issue and you are going to get a lot of support because people
are on your side on this issue.
The tobacco companies, for example, you know that
nitrosamines for example, are highly carcinogenic. They have
the technology to reduce that, they are not doing that. That is
one of the things that FDA could do. But, I just want to say
that, you know, we had--the FDA issued in 1996 these
regulations, and the Supreme Court said they didn't have the
legislative authority with which to do that.
But they said, the tobacco companies said they were going
to voluntarily not market to kids, that they were going to not
do that. Well, they have been saying that for a long time. A
recent Federal Trade Commission report showed that in the first
year after the settlement, tobacco marketing expenditures went
up 22 percent to a record $8.24 billion per year, and much of
the increase was in marketing efforts that reached kids. Two
for one discounts that reduced cigarette prices, payments to
stores for high visibility shelf displays, et cetera.
So I tell you, I personally believe the FDA needs to have
the ability to rein in the industry and protect our kids. That
is what FDA is supposed to do, supposed to protect us are from
unwarranted drugs, unsafe foods, and cigarettes.
The regulations that FDA issued included a number of
restrictions, including banning of outdoor advertising within a
thousand feet of schools, it would have allowed only black and
white text appearing in publications with youth readership.
TOBACCO ADVERTISEMENTS
Senator Harkin. I am going to ask Sabrina to hold this up.
This was in Cosmopolitan. 1,463,000 teenagers, they say mostly
girls read it, and that is the ad for Virginia Slims, and that
is what these young girls are reading. There is no question in
my mind now why lung cancer now has overtaken breast cancer as
the most pervasive cause of death among women in America today.
Secretary Thompson. Very true.
Senator Harkin. It is true. And we are finding out more and
more that the tobacco companies have been targeting women and
young girls, getting them hooked young.
Well, I do not know that I have so much of a question,
except just to say, Mr. Secretary, I urge you to continue your
efforts, and I do not mean to put you on the spot or anything
like that, but I just want to know how you feel about the FDA
having that kind of authority to restrict this kind of
advertising, to restrict where they can put tobacco on store
shelves, all the things that were in the regulations that FDA
issued in 1996 which the Supreme Court took out, and which I
hope we in Congress are going to address.
Secretary Thompson. This is a big issue, Senator Harkin,
for me and obviously for you, and I appreciate that. It is
amazing that 165,000 women died last year which was directly
caused by tobacco smoking, and 30 percent of our teenagers in
high school have tried cigarettes--32 percent of our teenagers
have tried a cigarette or tobacco in the last 30 days.
Senator Harkin. How many?
Secretary Thompson. Thirty two percent. And the record
shows that if in fact you are able to prevent teenagers from
smoking, that there is an 80 percent chance that people will
not smoke after they reach age 21. So it is obvious that we
have to address this problem.
In regards to regulation, really it is going to be up to
Congress if they can pass the bill. FDA should have some
regulation, should be able to do it, and I would welcome that
opportunity, Senator.
Senator Harkin. I appreciate your forthright statement.
Secretary Thompson. Thank you.
Senator Harkin. My yellow light is on too. I have one
question about Medicaid and managed care for disabled, but I
guess I will have to wait for my second round.
Senator Specter. Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman, and
thank you, Mr. Secretary.
Secretary Thompson. How are you, Senator?
Senator Murray. I am doing great. Good to see you here at
our committee, and I look forward to working with you on this
very very important piece of our budget.
I have a first question today about the nursing shortage,
and I think everyone of us have heard----
Secretary Thompson. It is a real problem.
NURSING SHORTAGE
Senator Murray. There is a real shortage, I am very
concerned about it, and I see that the President proposed to
redirect health profession funds from physician education to
professions like nursing, which is one step, but in talking to
a number of our technical schools and community colleges that
do a lot of the initial training on this, they are telling me
that the impact has come from welfare reform, which has changed
the emphasis and only gives 1 year credit for education, so
that there is not an incentive for women and men on welfare to
go into nursing, because they don't get the exemption long
enough to get the training that they need. I think it is really
important to have some flexibility in the welfare program to
provide that education and training, and I just wanted to find
out if you would support extending that current 12-month
education work standard in order to meet the growing nursing
needs in our hospitals and nursing homes.
Secretary Thompson. If I could just broaden the question a
little bit, I would appreciate it, Senator Murray. Nursing
shortage is a severe problem in America and it is going to get
worse, especially for the nursing home industry.
Currently, we are 90,000 short for registered nurses,
250,000 short on CDNs, and it is very important that we address
it, and I applaud you for your leadership. It is also a big
concern of mine and the Department so we want to do something
about it.
In regards to welfare reform, TANF is not going to be
reauthorized until next year, and I will be more than happy to
work with you to find ways on how we can encourage it, but I do
not think welfare reform is the cause for the nursing shortage.
The nursing shortage is caused by long hours and shortage, in
the fact that the working conditions have not been the best for
nurses. What we have to do as a Congress, and as an
administration, we have to look at ways to encourage that.
I think we also have to consider the possibility, and I
know this is not popular, but you are asking my opinion, so I
think we are also going to have to look at seeing how we might
be able to encourage immigration avenues to encourage people
that want to come to the United States to go into the health
professions.
I am very concerned about the future of nursing home
industries unless we get more CNAs. Projections are that the
CNA shortage is going to go from 250,000 possibility up to
400,000 in the near future and that's going to be a very
serious problem for you, for me, and for America.
Senator Murray. Well, I really appreciate the fact that you
understand this and I want to work with you on this.
Secretary Thompson. I really want to work with you too. It
is an issue that is very near and dear to me.
Senator Murray. I agree that wages, long hours is a
contributing factor, but in talking to many of the facilities
in my home State that train and educate, particularly women
obviously, into these professions, there are not women
applying, and one of the----
Secretary Thompson. They are not, and we have to encourage
people to do that.
Senator Murray. And I think one way to encourage that and
help promote that would be to extend that education work
standard for 2 years specifically for a nursing program.
Secretary Thompson. I would be more than happy to work with
you on that, and I am very supportive of issues like that, and
how we can encourage more young people to go into the nursing
profession.
CHILD CARE
Senator Murray. Very good, okay.
Another quick question. In the President's budget he
increases funds for child care for older children, which I am
pleased to see, but I also notice that he cuts Federal support
for child care for younger children by $200 million, which
seems to go against the welfare reform standards that have been
advocated, which require that even women with young children
need to be in the work force earning wages. Was there a study
that showed that there was a drop in the national needs for
child care for younger children?
Secretary Thompson. No, but I have to dispute your
conclusion. I do not want to be in a position of being
confrontational, but the baseline was $2 billion, and the
discretionary money. We are putting in 200 million more, or a
10 percent increase, to $2.2 billion for child care in the
discretionary fund. And out of that discretionary fund of $2.2
billion, the President says instead of just having a block
grant going back to the State, he wants to earmark $400 million
of that $2.2 billion, or the 10 percent increase plus the
additional $200 million, to allow for children between the ages
of 13 and 19 to be able to have after school care. He thinks it
is a real serious problem. Instead of a cut, it is going to
allow for 500,000 additional students to be taken care of under
the program.
The second thing is, there also is the mandatory side of
child care, and that is a $150 million increase. So instead of
a cut, there has been a $350 increase in child care, a 10
percent, and a total of $4.9 billion totally, and that is $350
million over what it was last fiscal year 2001.
Senator Murray. Thank you for that, and I know my time is
up. I do want to talk to you at some point about the SCHIP
program.
SCHIP
Secretary Thompson. Sure, I would love to talk about it.
Senator Murray. My question is one that is penalized for
where we have gone with that, and I would like to talk to you
about some flexibility in that program so my state and others
that have been trying to do the right thing are able to fall
into that program.
Secretary Thompson. Your Governor, I think, has been in to
see me on it.
Senator Murray. Good, thank you.
Senator Specter. Thank you, Senator Murray. Senator
Landrieu.
HEALTH CARE
Senator Landrieu. Thank you. And Mr. Chairman, this is my
first meeting and I want to tell you how pleased I am to be on
the committee and to serve with our ranking member and my
wonderful friend and colleague, and Mr. Secretary, it is a
pleasure to be with you this morning.
Secretary Thompson. Thank you, Mrs. Landrieu.
Senator Landrieu. Let me follow up on what Senator Murray
was highlighting and just associate myself with her remarks,
because the issue of health care and child health and the
nursing shortage is on everyone's mind and really is at the
heart of our efforts to deliver a quality health care system
for this nation.
Secretary Thompson. Absolutely.
Senator Landrieu. I mean, without nurses it cannot be done,
with all due respect to doctors and the other health
professionals----
Secretary Thompson. You are absolutely correct.
Senator Landrieu [continuing]. That nurses are really the
heart of that whole enterprise, and we have a real, I would
almost say crisis in this Nation regarding that, and it is
going to take a bipartisan sort of multifaceted effort to try
to come up with some immediate solutions.
But, I want to follow up on this additional child care
piece that Senator Murray brought out, because I was looking at
the numbers too, and want to work with you to increase our
investment in child care, recognizing that the current budget
underserves millions and millions of communities. And without
the child care dollars, particularly for young children, but of
course as you mentioned, there are needs for children of all
ages after school, targeted to those communities of working
families where both spouses are usually having to work not one
job but two jobs, child care becomes essential to that family
being able to work their way out of poverty, and to build the
wealth and assets necessary to provide for their children.
So if the Government fails to meet them halfway on this
issue, we are really not living up to, I would say, the minimum
that we should do. And I wanted just to point out that the way
we have added the numbers, it does seem like there is a cut in
this area as opposed to a real increase, because although you
are increasing the overall number, you are earmarking a certain
percentage for older children, and the only place it can come
is from the younger children's discretionary portion.
So, I do not want to argue those numbers this morning, but
just to say that I would like to try to get some clarification
at a later date if that is not the case, then, because it seems
to us that that most certainly is the case.
The second point is the area of foster care and stable
families. I want to work with you on that.
Secretary Thompson. So do I.
FOSTER CARE
Senator Landrieu. Because as you know, governments do a lot
of things well, but one thing we do not do very well is raise
children, and children are best raised in families, in
permanent stable relationships with either one responsible
caring adult, preferably two parents, but one responsible adult
can and in many instances do beautiful jobs. So we need to try
to support children in the biological families to which they
are born but if that cannot take place, to try then to find
them a real family, not an orphanage, not an institution, not a
group home, but a real family.
And so I would just say that throughout the budget, I am
going to be focused on all of the programs that encourage
reunification where possible, but then a permanency for
children to be placed into a family. So with your prisoners
initiative, I just wanted to ask and make a point that we want
to make sure some of these children can be reunited with
parents who spent long time in prison, but if it is not
possible for the reuniting, that we should really work to
provide another home for children and not take that opportunity
away from them to have a family.
I just want to raise that and look forward to working with
you on adoption and foster care issues particularly.
Secretary Thompson. You have raised several things and I
would like to respond to all of them, if I might, Senator
Landrieu.
NURSING SHORTAGE
It is really heartening for me to hear, both from you and
Senator Murray, about your passion for increasing nursing. It
is something, we really have a problem facing us as a country,
and if we are going to have a quality health care, we are going
to have to find ways to increase the number of people applying
for nursing school. I do not know how much more I can tell you
than I want to work with you.
It is a very important thing for the department because
with all the additional rules and regulations we are imposing
upon nursing homes for more nursing care, and we do not have
the nurses to staff it, we are going to cause severe problems
to that industry as well as taking care of our elderly
citizens, our mothers and our fathers, so it is a problem we
have to take care of.
CHILD CARE
In regards to the dollars, there is a block grant of $2
billion in discretionary funds for fiscal year 2001. We put an
additional $200 million, which is a 10 percent increase; it
goes from $2 billion to $2.2 billion.
Now we earmarked $400 million for after school children,
because we found, and I found as a governor that we could not
use this money to take care of a real serious problem. And
those are the freshmen and sophomores, and juniors, seniors
could care less, but they should be taken care of as well, but
they were not as interested. But the boys and girls schools,
the clubs, the opportunities to have athletic programs and
educational programs after school is so important. And that's
why the President felt that this was something really needed.
So there is a 10 percent increase in it, but $400 million
has been earmarked, there is no question about that, I am not
trying to hide that. So, I mean, it is a block grant.
Then on top of that, we added an additional $150 million on
the mandatory side for child care. You are talking to somebody,
you know, when I was a Governor, I went from $12 million to
$300 million my last year for child care. And I have told this
Senate and I have told the House many times when I was a
governor, if you are going to have welfare reform, you have to
take care of the children, you have to be able to have child
care. We did not have any waiting lists when I left as governor
in the state of Wisconsin.
Senator Landrieu. You did an excellent job.
Secretary Thompson. And so that is a passion of mine, and I
want to work with you in the reauthorization of TANF on that,
but I really think the figures speak for themselves. There is
an increase of $350 million for child care, and there is an
attachment, that the money goes for that, but it actually takes
care of 500,000 additional children.
FOSTER CARE
In regards to foster care and adoption, all I can say is I
agree with you. I mean, we need to do it. But the President has
also recognized that the fathers are very important. That is
why we have a fatherhood initiative, and you know that. We have
to have fathers being reintegrated back into the family, and
that is why we put an additional, a new program, $67 million,
for fathers to come back in, also $64 million for prisoners to
be reintegrated. And prisoners are going to get out of jail,
and we want them somehow to have the skills necessary to be
reintegrated back into that family.
And so those are two new programs that I think and hope
that you would support.
Senator Landrieu. Well, I know my red light is on, but let
me just say that you have been really one of the leaders in
this area, and I want to applaud you. If our Federal budget
would reflect the kind of priorities and investments that you
made as Governor, we would be a heck of a lot better off in
this nation, so God bless you and thank you for all your good
work.
Secretary Thompson. Thank you, ma'am.
YOUTH VIOLENCE
Senator Specter. Mr. Secretary, moving to a number of other
subjects, this subcommittee took the lead 2 years ago in
allocating almost a billion dollars to the subject of youth
violence from existing programs, and we did it in not a low key
way, but a no key way, just had working sessions with the three
Departments for which we provide appropriations, yours, Labor,
and Education, and also the Department of Justice was involved.
I call this program to your attention specifically,
although I know you're aware of it. The administration's
funding reduced the programs which we have designated here by
more than $250 million. I had called Miss Margaret Lamontaine,
the domestic counselor, and I mention it at this time for the
purpose of asking for your staff review and your review with a
view to implementing this program. It has a lot of facets and
what we really need to do is to see that these monies are being
well spent in the areas to which they are directed, and we will
be following up with you.
Secretary Thompson. I appreciate that, Senator. As a new
Secretary that has been here for 75 days, how can we interact
with your office better to develop a coordinated effort in
regards to this thing? How can we use your abilities and
intellect in this, Senator Specter, as a prosecutor and as a
Senator, to do something in the area of youth values and to
make sure that the dollars are being well spent to accomplish
what you and the other Members of Congress have rightly set up?
Senator Specter. Mr. Secretary, I believe that we ought to
do it at the highest level with our chiefs of staff and
Bettilou Taylor, who is my key executive on the subcommittee,
and who is very very experienced, and have a monitoring
program. We have to include the domestic advisor to the
President, Miss Lamontaine, and what I think we really ought to
do is have the three Secretaries and Senator Harkin and myself
sit down, and perhaps invite the Attorney General, because the
Department of Justice is involved, and really give it that kind
of high level treatment. Because as you well know, when youth
violence breaks, then everybody is aghast, and we have not----
Secretary Thompson. We have not had a coordinated effort.
Senator Specter. There is, as I say, no publicity, it is
very quiet, with working sessions, but the way to carry forward
would be at the top level and devise monitoring programs with
very high ranking people in our offices.
Secretary Thompson. Could you call a meeting such as that?
Senator Specter. I will. I want to work through, as I say,
Miss Lamontaine to get the White House involved in it.
Secretary Thompson. Fine.
FAITH-BASED INITIATIVES
Senator Specter. Because there is going to have to be a
fair amount of their oversight and supervision on it
ultimately.
With respect to the faith-based initiatives, Mr. Secretary,
with some $89 million for the compassion capital fund in your
department, $67 million for supporting children of prisoners
and $64 million to promote responsible fatherhood, how do we
carry these programs forward respecting the important
separation of church and state?
Secretary Thompson. We just have to be very diligent, we
have to make sure that our programs are set up in such a way
that they will not violate the Constitution, and that we have
to monitor them on a regular basis to make sure that that
doesn't happen. I think Head Start is a prime example. I do not
think many people realize this, but almost two-thirds of the
funds in Head Start go into faith based organizations, and they
do a wonderful job and I do not think there has been any
criticism of the Head Start program of money going into faith
based organizations. I use that only as an example of one that
really is working, and that is the kind of model that I think
we should probably try to emulate.
Senator Specter. Do you anticipate issuing any regulations
to establish the guidelines?
Secretary Thompson. Absolutely, sir.
ALTERNATIVE MEDICINES
Senator Specter. All right. We will look forward to seeing
those.
On the subject of alternative medicine, that is a matter
where Senator Harkin and I have been keenly interested and have
had a number of hearings on over the course of the past decade.
The funding has been increased from $7 million to about $100
million, and I would like to call your attention this morning
to a specific program by Dr. Herbert Benson, who is the
president of the Mind Body Medical Institute. He has developed
some really remarkable research on the benefits of releasing
stress through medication and other approaches, and the impact
on children.
The red light is on, so I will conclude my portion now by
just saying that I am going to be sending over some material to
you from Dr. Benson because I think this is worthy of
consideration at your level.
Secretary Thompson. Fine, thank you. I will be looking
forward to receiving it and reading it.
Senator Specter. Good. Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman. I ask a point of
personal privilege to ask a question that Senator Byrd wanted
to ask, and not be deducted from my time.
Senator Specter. Certainly.
Senator Harkin. Senator Byrd apologizes that he could not
be here, but he wanted me to ask this question, Mr. Secretary.
Secretary Thompson. Yes.
OBESITY RATES
Senator Harkin. Why at a time when obesity rates are
skyrocketing to the point that two-thirds of adults and a
quarter of children are overweight or obese, is the
administration cutting funding to the Centers for Disease
Control and Prevention's nutrition, physical activity and
obesity program by 10 percent, when you should be expanding the
program, and what specifically does the administration plan to
do to help reduce obesity rates among adults and children?
Secretary Thompson. I wish I had an answer to that, and I
really do not. It is a problem facing America but it is also a
problem facing the whole world. People down at CDC, I went down
there to talk to them about diabetes, which is a growing
problem, skyrocketing. And the people at CDC tell me, Senator,
that 75 to 80 percent of the diabetic conditions can be
challenged or changed by two things, watching our diet and
exercising.
And I am going to make prevention a real cause for the
Department of Health and Human Services, and we are already
putting in place and I hope you pass that on to Senator Byrd,
and people tell me that diabetes impacts on the Medicare budget
by about 4.9 percent. And I do not know if that is correct, and
I do not know of the 75 to 80 percent, those were the figures
given to me, I think they are both very high, but even if they
are close, what we could do for health care, health budgets,
and improved quality of life by doing this is something that I
want to address.
Now I did not get involved in the budget until very late,
and prevention is a cause that I want to pursue, and I am not
going to make any other apologies other than I think we have to
address it, we have to address obesity because it is a growing
concern in America, and I think the Department of Health should
be the real model of trying to change that and improve it, and
I would solicit your help and that of Senator Byrd in
accomplishing that, and hopefully we can.
Finally, I would like to say that the Department is going
to do everything possible to put in an initiative, hopefully
with the co-chairmen, Senator Specter and you, Senator Harkin,
on this sometime this year. We have no ideas yet, but we are
working on it, and we would like to come to you after we bring
something together and talk to you about it.
Senator Specter. Senator Harkin, I think Senator Byrd's
time is up.
Senator Harkin. I am going to take off on that now with my
time. But Mr. Secretary, one thing I suggest, or I hope that
you will work with us on, putting on another hat, I am also
ranking on the Agriculture Committee of Senator Lugar.
Secretary Thompson. Yes, sir.
NUTRITION PROGRAMS
Senator Harkin. Our farm bill is up next year. One big part
of that is the nutrition program, school lunch, school
breakfast, all the feeding programs. And quite frankly, we have
to do something about our school lunch programs out there.
These kids are getting too much fat in their diets, and the
difference between that and the school breakfast program is
like night and day.
Secretary Thompson. I think we need to add more milk,
cheese, and corn.
Senator Harkin. Skim milk, low fat cheese, and Soy, do not
forget Soy, you have to get Soy in there, healthy for the heart
and all that.
Also the vending machines problems that we have in schools,
things like that. Now that may be out of your purview, but you
are a leader in this area, and I thought we had it fixed before
about keeping the vending machines off until after the last
meal is served in school, but we have to address that problem
too, so I hope we can work with you in sort of a cross-track on
this with the Agriculture Department on this too in the feeding
and the food programs, but I didn't mean to go off on that.
Secretary Thompson. No, no, I appreciate it. I think it is
something we should do.
Senator Harkin. We should work together on that.
Secretary Thompson. Absolutely. I do not think there is
enough cooperation in the Federal Government in regards to this
thing, and I would like to see what I can do as a leader.
Senator Harkin. That is one area where you and Ann Veneman
could really work together on that nutrition program.
Secretary Thompson. Appreciate that.
MEDICAID PROGRAM
Senator Harkin. In 1997 Congress made changes to the
Medicaid program allowing States to mandate that Medicaid
beneficiaries be enrolled in managed care plans, and they
included people with disabilities. But we also required that
there is a basic set of protections. As a result, HCFA issued
guidelines and the guidelines went out, they are critical,
especially for people with disabilities, to get the quality of
care that they deserve. These regulations lay out standards,
continuity of care, all that kind of stuff. In February, the
administration announced the delay of this regulation.
I know it was caught up in all these things they delayed. I
do not know about the other ones, but on this one I think it is
unwarranted. President Bush has called for a patient's bill of
rights for those who have private health insurance. How about
the Medicaid people that are being put into the managed care
plans, especially those people with disabilities, and I just
hope that you will push to get this regulation out and get the
delay off. I think it was just caught up in all those, but I am
asking you to look at it.
Secretary Thompson. I appreciate that, and I will. I will
look at it before the end of the week and get back to you,
Senator.
Senator Harkin. I would really appreciate that very much.
Lastly, on restraints. We have all these studies that show
that a lot of adults and children with disabilities have died
as a result of restraints, there have been lots of stories on
it. We just had recently two deaths in Iowa of young people
being restrained, and these are now being investigated of
course, but there are some regulations, again regulations that
were supposed to have come out, to provide guidelines for the
appropriate use of restraints in Medicaid funded facilities.
They were supposed to be effective by March 23, and they are
not there yet. The regulations were going to prevent the types
of deaths that I just described, the two that just happened in
Iowa.
The GAO in September 1999 reported on restraint and
seclusion and found conclusively that children are especially
vulnerable to this unsafe practice. What is done, it is being
used a lot of times just as a means of the caretakers in those
facilities, if some kids act up and they do not have time to
take care of it, put them in restraints, and it is used as
punishment a lot of times too, and those regulations would
address that.
And again, second, I hope you take a look at it and see why
they are not getting out there.
Secretary Thompson. You know, there was an order put out
that all these rules and regulations were going to be delayed
for 60 days and the one on Medicaid is all wrapped up in the
60-day review period, Senator.
Senator Harkin. Have all these people that work for you
take a look at them.
Secretary Thompson. I will, thank you.
Senator Harkin. Thank you, Mr. Secretary.
FAMILY PLANNING
Senator Specter. Mr. Secretary, one final subject, and that
is the issue of family planning, birth control, and abstinence
only education. This subcommittee has taken the lead in
appropriating funds in the past for abstinence only education.
The controversy exists that to talk about abstinence only is
unrealistic, because facts of life being what they are, unless
birth control devices are provided simultaneously, that the
abstinence education will not work.
My own view has been that there is room in our budget, room
in our society, for both efforts, family planning with their
approach, which may include birth control as they protect their
programs, but separate programs for abstinence only education,
where a large part of our society which feels so strongly that
birth control ought not be made available, and ought to have an
opportunity with abstinence only education to see if that will
provide an answer.
Obviously, this is one of the most contentious issues
facing our society with all the ramifications that come from
these issues, and I would be interested, the subcommittee would
be interested, to know what the administrations plans and your
Departments' plans are on family planning and abstinence only
education.
Secretary Thompson. The President has taken a very strong
position that they should be treated equally, and currently
there is an underfunding on the abstinence side, about $93
million compared to $135 million on the birth control side. And
there is a movement afoot to evaluate our programs to try and
make them equal, and this is something that the President feels
very strong about, Senator, and we are working on that.
Senator Specter. Mr. Secretary, that is a fair amount of
ground, that cannot be comprehensive. And I was just about to
sound the gavel until our very distinguished colleague, Senator
Herb Kohl arrived.
Secretary Thompson. You can never sound the gavel when the
distinguished Senator from Wisconsin is here, plus the fact
that his Bucks are doing a great job in the championship, and
we are pulling for them, and I hope the people in Iowa and
Pennsylvania are as well.
Senator Specter. I see the ruling of the Chair has been
challenged?
And the ruling of the Chair has been defeated, so we will
hear from you, Senator, as we always do.
Senator Kohl. What do you want?
Thank you very much, Senator Specter.
Senator Specter. Senator Kohl and I have worked together
very closely, most noteworthy on the Ruby Ridge hearings, and I
have been trying to get him to autograph my copy for 5 years.
That is what I want.
Senator Kohl. Done.
Well, it is good to see you.
Secretary Thompson. Good seeing you, my friend.
Senator Kohl. Mr. Secretary, Governor.
Secretary Thompson. Thank you.
CHILD SUPPORT REFORM
Senator Kohl. Mr. Secretary, you visited my office before
your confirmation hearing and we talked about our shared
interest in reforming the child support distribution system.
Secretary Thompson. Right.
Senator Kohl. At that time you were just beginning your
current job, but now that you have had a few months and a
budget under your belt, I would like to discuss it just a
little bit further. As you know, under current law, a lot of
child support money never actually reaches the child. Instead,
the state and Federal Governments keep it as reimbursement for
their expenses. In Wisconsin, thanks to your leadership, Mr.
Secretary, our State----
Secretary Thompson. And your support, Senator.
Senator Kohl. That is right. We have a successful waiver
program to send more child support money directly to families.
I have introduced legislation to give all states the option to
follow Wisconsin's example. The bill is included in the
bipartisan Strengthening Working Families Act, which includes
several other administration supported initiatives to help
families succeed.
Given your long history on this issue and the bipartisan
support that we have had, can you tell us if the administration
will support this initiative?
Secretary Thompson. I know I do. I have not talked to the
President about it, I am confident that he will, and if you
want me to find out how the administration feels, I will be
more than happy to, but I strongly support it because it is the
right thing to do.
We pioneered that in Wisconsin, and the beauty of it is it
gets more money to the mother and to the children and it just
makes, you know, common sense. And so I am, I cannot say 100
percent that the administration is in favor of it, but I am,
and I will do everything I possibly can to convince them if
they are not, but I would dare to say if we can get your bill
introduced, you are going to find this administration fully
behind you support of it, Senator, and I hope that you push it
hard and I would love to be able to be called to testify on it
if and when there is a hearing on it.
Senator Kohl. Thank you, that is very encouraging.
Secretary Thompson. And I also want to thank you again for
the great job you are doing with the Bucks. It is great.
NURSING HOME INITIATIVE
Senator Kohl. Thank you very much, Mr. Secretary. I would
like to ask a question on nursing home enforcement. I have been
fighting for several years to increase funding for nursing home
inspections. Although most nursing homes do a good job, we
still have way too many nursing homes with serious problems,
including malnutrition, dehydration and bed sores.
In response to these problems, the Clinton administration
launched a nursing home initiative which has had bipartisan
support. This included mandates on State inspecters to make
their inspections less predictable, to respond more quickly to
complaints, and to refer deficiencies for immediate sanctions.
The Federal Government is the primary source of funding to
the states to carry out these duties. Unfortunately, the
President's budget flat lines this funding. If we know that
substandard care is a serious problem in our country and if we
are all serious about improving care, and I am sure you are,
then we really have to invest in the inspection process. We
have to give states the money they need to protect their
residents. How do you expect States to carry out these critical
duties if we do not have an increase in funding? In other
words, as you well know, the inspections often times get
nursing homes to do a better job, and if we do not increase our
ability to do inspections, how can we expect nursing homes to
do a better job?
Secretary Thompson. We are reviewing all those rules and
regulations, Senator. I have no definite answer for you at this
point in time. I think that sometimes we waste money and time
continuing to inspect the good homes, and should be spending
more time on the ones that have had violations in the past, got
complaints, and so on and so forth, and accentuate the surveys
and inspections there, and also do them at different time
intervals so that nobody knows that they are coming, and see if
in fact we can improve the quality of nursing care for our
senior citizens all over.
And so, we are looking at that, and that is the best answer
I have for you at this point in time, but I will be more than
happy to sit down with you in the future to discuss it in
further detail.
Senator Kohl. Okay. Again, I would just make the comment
which, I would like to hope you would at least partially agree
with, that to the extent that we inspect, we can expect to have
some improvement; to the extent that we inspect less, we are in
greater peril. And as I said, the money for the inspections
comes from us here in Washington, so I think it is something
that deserves attention.
Secretary Thompson. Okay.
Senator Kohl. Last question. As you know, Mr. Secretary,
for the past 7 years, Wisconsin's nursing homes have been using
trained single task workers to help feed residents during busy
mealtime hours. This frees up more time for other nurse aides
to provide other critical services. Unfortunately, last year
HCFA informed Wisconsin that this practice does not comply with
federal law. I am concerned that the immediate removal of all
single task workers would only worsen the staffing shortages
that our nursing homes are already facing.
I have introduced legislation to allow Wisconsin to
continue using single task workers as part of an eight-state
demonstration project. These workers would have to be trained
and supervised at all times, and a thorough evaluation of the
project would be done to determine their impact on quality of
care.
Would the administration support this kind of demonstration
project, Mr. Secretary?
Secretary Thompson. Without a doubt, yes, and
enthusiastically, I might add, and it is a problem, and I think
the rules that were interpreted, the law needs to be changed,
so that HCFA can make the right interpretation. And I will be
very supportive of it. I know exactly what you are talking
about. It is causing a problem not only in Wisconsin, but
nursing homes, especially in the midwest and I presume across
America, and it is something that needs to be changed, the law
needs to be changed, and let us push forward with it as fast as
we possibly can.
Senator Kohl. Well, I thank you, that is great to hear, and
you are a great guy and I have always felt that way, and since
you have been here in Washington, I increasingly feel that way
and I look forward to working with you.
Secretary Thompson. My privilege, sir, and thank you very
much for your kind words, and I feel the same about you.
Senator Kohl. Thank you, Mr. Secretary.
Senator Specter. Mr. Secretary, I have been involved in a
few of these hearings, none has surpassed all of the
complimentary comments about you. You got a lot of praise and a
very high standard to live up to.
Secretary Thompson. I certainly do.
Additional committee questions
Senator Specter. And I join all of the complimenters in
saying that we are confident that you will do it.
Secretary Thompson. Thank you very much, Senator.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Question Submitted by Senator Arlen Specter
faith-based initiatives
Question. President Bush's Faith-Based plan created five faith-
based centers. One of the centers in located in HHS. What will be the
role of the center? How will this center be funded? How will this
center interact with the White House Office of Faith Based Programs?
Answer. Established by Executive Order on January 29th, 2001, the
Center for Faith-Based and Community Initiatives within the Department
of Health and Human Services will coordinate departmental efforts to
eliminate regulatory, contracting, and other programmatic obstacles to
the participation of faith-based and other community organizations in
the provision of social services. To maintain coordination with the
White House Office of Faith Based and Community Initiatives (OFBCI),
HHS has designated a Center employee to serve as the liaison and point
of contact with the White House OFBCI, cooperate with the White House
OFBCI, and provide such information, support, and assistance to the
White House OFBCI as it may request, to the extent permitted by law.
The President's budget includes $3 million within the
Administration for Children and Families to fund the Center for Faith-
Based and Community Initiatives in 2002.
Question. President Bush's Faith-Based initiative calls for the
expansion of Charitable Choice. What areas of Health and Human Services
would benefit from this proposed action?
Answer. Beginning in 2001, the HHS Center for Faith-Based and
Community Initiatives will (a) conduct a comprehensive review of
policies and practices affecting existing funding streams governed by
so-called ``Charitable Choice'' legislation to assess the department's
compliance with the requirements of Charitable Choice; and (b) promote
and ensure compliance with existing Charitable Choice legislation by
the department, as well as its partners in State and local government,
and their contractors.
Question. How will this expansion comport with the Constitutions
Establishment clause?
Answer. Charitable choice is often portrayed as a source of new
federal financial assistance made available to--indeed earmarked for--
religious charities. It is not. Rather, charitable choice is a set of
grant rules altering the terms by which federal funds are disbursed
under existing programs of aid. As such, charitable choice interweaves
three fundamental principles, and each principle receives prominence in
the legislation.
First, charitable choice imposes on both government and
participating FBOs the duty to not abridge certain enumerated rights of
the ultimate beneficiaries of these welfare programs. The statute
rightly protects these individuals from religious discrimination by
FBOs, as well as from compulsion to engage in sectarian practices
against their will.
Second, the statute imposes on government the duty to not intrude
into the institutional autonomy of faith-based providers. Charitable
choice extends a guarantee to each participating faith-based
organization [FBO] that, notwithstanding the receipt of federal grant
monies, the organization ``shall retain its independence from Federal,
State, and local governments, including such organization's control
over the definition, development, practice, and expression of its
religious beliefs.'' In addition to this broadly worded safeguard,
there are more focused prohibitions on specific types of governmental
interference such as demands to strip religious symbols from the walls
of FBOs and directives to remake the governing boards of these
providers. A private right of action gives ready means of enforcement
to these protections of institutional autonomy.
Third, the statute reinforces the government's duty to not
discriminate with respect to religion when determining the eligibility
of private-sector providers to deliver social services. In the past, an
organization's ``religiosity,'' obviously a matter of degree not
reducible to bright-lines, was said to disqualify providers found to be
``pervasively sectarian.'' That inquiry was always fraught with
difficulties. Now, rather than probing into whether a service provider
is thought to be ``too religious'' as opposed to ``secular enough,''
charitable choice focuses on the nature of the desired services and the
means by which they are to be provided. Accordingly, the relevant
question is no longer ``Who are you?'' but ``What can you do?'' So long
as a provider is prepared to operate in line with all statutory and
constitutional parameters, then an organization's degree of
``religiosity'' is no longer relevant.
When discussing Establishment Clause restraints on a government's
program of aid, a rule of equal-treatment or nondiscrimination among
providers, be they secular or religious, is termed ``neutrality'' or
the ``neutrality principle.'' Charitable choice is consistent with
neutrality, but courts need not wholly embrace the neutrality principle
to sustain the constitutionality of charitable choice.
The U.S. Supreme Court distinguishes, as a threshold matter,
between direct and indirect aid. For any given program, charitable
choice allows, at the government's option, for direct or indirect forms
of funding, or both. Indirect aid is where the ultimate beneficiary is
given a coupon, or other means of free agency, such that he or she has
the power to select from among qualified providers at which the coupon
may be ``redeemed'' and the services rendered. In a series of cases,
and in more recent commentary contrasting indirect aid with direct-aid
cases, the Supreme Court has consistently upheld the constitutionality
of mechanisms providing for indirect means of aid distributed without
regard to religion. The Child Care and Development Block Grant Program
of 1990, for example, has been providing low income parents indirect
aid for child care via ``certificates'' redeemable at, inter alia,
churches and other FBOs. The act has never been so much as even
challenged in the courts as unconstitutional.
In the context of direct aid, the Supreme Court decision that has
most recently addressed the neutrality principle is Mitchell v. Helms.
The four-Justice plurality, written by Justice Thomas, and joined by
the Chief Justice, and Justices Scalia and Kennedy, embraced, without
reservation, the neutrality principle. In the sense of positive law,
however, Justice O'Connor's opinion concurring in the judgment is
controlling in the lower courts and on legislative bodies.
Before proceeding in greater detail, the controlling principle
coming from Mitchell v. Helms can be briefly stated: A government
program of aid that directly assists the delivery of social services at
a faith-based provider, one selected by the government without regard
to religion, is constitutional, but real and meaningful controls must
be built into the program so that the aid is not diverted and spent on
religious indoctrination.
Based on Justice O'Connor's opinion, when combined with the four
Justices comprising the plurality, it can be said that: (1) neutral,
indirect aid to a religious organization does not violate the
Establishment Clause; and (2) neutral, direct aid to a religious
organization does not, without more, violate the Establishment Clause.
Question. The President's budget shows new faith-based budget items
under Health and Human Services and proposes the expansion of others.
Please share with the subcommittee the details of the following policy
items:
--Compassion Capital Fund
--Supporting Children of Prisoners
--Promoting Responsible Fatherhood
Will these programs need new authorization? If not, what is the
existing authorization?
Answer. The new proposed discretionary initiatives represent a new
Federal commitment in providing social services to those in need.
Through these initiatives, the Administration wants to spur new
community-level approaches to working with low-income families. The
Administration will look to all successful sources of support for those
in need--faith-based organizations, charities, and community groups.
These groups do not replace Government, but partner with it.
The Compassion Capital Fund will provide start-up capital and
operating funds to qualified charitable organizations that wish to
expand or emulate model social service programs. The program will also
promote research on ``best practices'' among charitable organizations.
Another new program, Mentoring Children of Prisoners, will help
children through the time their parents are imprisoned, including
efforts to keep children connected to a parent in prison, and increase
the chances that the family can come together successfully when the
parent is released. The President also proposes a program to Promote
Responsible Fatherhood. To strengthen the role of fathers in the lives
of families, this initiative will provide competitive grants to faith-
based and community organizations that help unemployed or low-income
fathers and their families avoid or leave cash welfare, as well as to
programs that promote successful parenting and strengthen marriage.
The President's fiscal year 2002 budget proposes to fund both the
Compassion Capital Fund and the Mentoring Children of Prisoners program
under existing authority within the Administration for Children and
Families. The Administration is proposing new legislation for the
Responsible Fatherhood Initiative, and looks forward to working with
the Congress on how to best structure this new program.
COMMUNITY HEALTH CENTERS
Question. You propose an increase of $124 million for community
health centers. This is less than the increase Congress provided last
year, yet the budget justification says that this is the first step in
a multi-year strategy that will eventually double the number of
patients seen at community health centers. Could you explain your
strategy?
Answer. The President's fiscal year 2002 budget for HRSA includes
nearly $1.3 billion for Health Centers program, an increase of $124
million above the fiscal year 2001 appropriation. These additional
funds in fiscal year 2002 will allow Health Centers to create 200 new
and expanded access points and serve up to 1 million additional
patients, almost half of them uninsured. The added funds represent the
first installment of the Administration's multi-year initiative, which
will eventually increase or expand health center access points by 1,200
over five years and eventually double the number of people served.
RYAN WHITE PROGRAMS
Question. Why are there no increases for the Ryan White programs,
not even for inflation?
Answer. The President's fiscal year 2002 budget includes over $1.8
billion for Ryan White activities, the same level as fiscal year 2001.
Ryan White activities have increased by over 81 percent, or $812
million, in the last 5 years. By maintaining funding at this level,
grantees will be able to manage these significant increases and address
the changes included in the reauthorization of the Ryan White CARE Act.
HEAD START
Question. The President's budget increases for Head Start is $125
million--an increase that only accounts for inflation. Last year's
budget increase allowed Head Start to serve 60,000 additional children.
This year's budget will not allow any additional children to receive
Head Start services. Can you explain the rational for this budget?
Answer. The President's budget provides $6.3 billion for Head Start
in fiscal year 2002, $125 million increase above the fiscal year 2001
funding level. This funding level will serve 916,000 children, the same
number that was served in fiscal year 2001. The program has received
significant funding increases in the past few years and has undergone
considerable expansion. In fiscal year 2002 we will work to ensure that
the program has the opportunity to absorb this dramatic growth while
focusing on strengthening pre-literacy and reading skills of the
children.
Question. With the Head Start increase only accounting for
inflation, can you tell us how many eligible children will not be
served in fiscal year 1902?
Answer. In 2002, Head Start will provide preschool services to
916,000 children (including 55,000 children in Early Head Start), or
approximately 60 percent of the eligible population of 1.425 million 3-
and 4-year old children nationwide.
CHILD CARE AND DEVELOPMENT BLOCK GRANT
Question. You have set-aside $400 million for use by the States to
provide certificates for low-income parents to help defray the costs of
after-school programs with an educational focus. With only a $200
million increase in the child care block grant, isn't this an effective
cut of $200 million in the block grant? Can you explain how this
program differs from the Department of Education's 21st Century
Learning Centers.
Answer. The President's budget supports child care services for 2.6
million children. This includes child care services for approximately
2.1 million children--the same number supported in 2001--and
certificates for up to 500,000 additional children to help parents
defray the costs of after school child care programs which have a high-
quality educational focus. The certificates will be available for
children who are less than 19 years of age.
The block grant is only one portion of the total funds for the
Child Care Development Fund. The fiscal year 2002 ACF budget includes
$4.917 billion in Federal resources for the child care services. This
funding represents a $350 million increase to the fiscal year 2001
level of $4.567 billion.
The After School Child Care Certificate set-aside is designed to
help pay the costs of high-quality after school child care by putting
money in the hands of parents who need it. As we understand it, the
21st Century Learning Center program provides funds to support after
school programs at schools. The After School Child Care Certificate
set-aside is directed to assist parents in paying for after school
care, whether in a school or other settings.
YOUTH VIOLENCE
Question. In January the Surgeon General issued a report on youth
violence which this subcommittee funded. The report was basically a
review of existing literature and contained no new research. I continue
to be concerned with the troubling outbreaks of violence by our
teenagers. Do you plan to conduct new research to help us understand
the causes of violent behaviors and ways to prevent and treat it?
Answer. The National Institute for Child and Human Development
(NICHD) will support research to understand how interactions between
the brain, hormones, and environmental stimuli lead to changes in teen
behavior, including youth violence. Researchers will also examine how
these processes interact with external factors as peers, family and the
community.
The National Institute of Mental Health (NIMH) has learned that
prevention programs must target multiple risk factors for youth
violence, for example, poor adult supervision, associations with
deviant peers, lower verbal intelligence, family conflict, impulsive
behavior, depression, social isolation, school failure, and substance
abuse. NIMH will continue and expand etiological and risk factor
studies and will expand research on youth violence interventions.
Question. Does the Administration have plans to address the role of
media in contributing to youth violence?
Answer. From a public health perspective, the Surgeon General's
Report on youth violence noted that the role of the media in
contributing to youth violence is largely uncharted territory. Few
preventive efforts have been studied systematically. Furthermore, not
enough research has been done to form a basis for the design of many
experimental interventions. Although many violence prevention programs
address a complex array of risk and protective factors in the lives of
young people, they have not yet addressed the role of the media.
Question. Mr. Secretary, given the unacceptably high rate of youth
violence in the United States and the reductions proposed in the
budget, how will the HHS fiscal year 2002 budget request support
programs that address youth violence?
Answer. The fiscal year 2002 request for HHS Youth Violence
activities totals $103 million. Of this amount $90 million is for the
Substance Abuse and Mental Health Services Administration (SAMHSA).
With these funds SAMHSA will provide grants to schools and community
organizations with the goal of building coalitions, establishing
prevention programs, and developing curriculum. Also included in the
fiscal year 2002 request is $11.6 million for the Centers for Disease
Control (CDC). This funding will allow CDC to develop and implement
multi-disciplinary research, develop and evaluate collaborative
prevention interventions, and develop a training curriculum. Funding in
the amount of $1 million for the Office of Minority Health will be used
to expand the Family and Community Violence Prevention Program and
$400,000 for the Office of Surgeon General will fund a series of
community listening sessions on topics highlighted in the Surgeon
General's Report.
______
Question Submitted by Senator Ted Stevens
special health needs of children with mental retardation
Question. On March 5, 2001, at the hearing in Anchorage, the
Special Olympics officially released the special report on The Health
Status and Needs of Persons with Mental Retardation. Specifically, the
Health Report found that (1) Although persons with mental retardation
need health and health financing programs that are responsive to their
particular needs, too often they are forced into general programs that
actually can compromise their health. People with mental retardation
may not be receiving health services because they are under-insured;
(2) The majority of health professional who are otherwise qualified to
treat persons with mental retardation fail to do so. This is largely
the result of a lack of appropriate, specific training, inadequate
reimbursement policies, fear, and prejudice; (3) Existing federal,
state and voluntary programs to meet the health needs of persons with
mental retardation are inadequate.
Mr. Secretary, what role can you play in training health
professionals to address the needs of person with mental retardation?
The report states that the health care system in this nation
provides financial disincentives for physicians and other health care
providers to work with patients with mental retardation. What can be
done to rectify this situation?
Answer. People with special health care needs have been of
particular concern to the Department for decades. Within HRSA's
Maternal and Child Health Bureau, our concern with mental retardation
has been a heightened priority for 50 years. Currently, the MCH
Leadership Education in Neurodevelopmental and Related Disabilities
(LEND) program improves the health and quality of life of children who
have, or who are at risk for developing neurodevelopmental or related
disabilities by preparing trainees from a wide variety of professional
disciplines to assume leadership roles to ensure high levels of
clinical competence. By providing interdisciplinary long-term training,
by developing exemplary clinical service models, and by reaching out to
the community through consultation, technical assistance, and
continuing education, the LEND program has made and will continue to
make significant strides towards developing comprehensive, coordinated
services for infants and children with the potential to have, or having
developmental disabilities and for their families. For fiscal year
2001, MCHB is providing $18.3 million through 35 grants in support of
the LEND program.
In addition, the Administration on Developmental Disabilities, ACF,
administers a national network of University Centers for Excellence in
Developmental Disabilities Education, Research, and Service (formerly
known as University Affiliated Programs). There are 61 Centers that
receive 5-year grant awards, for fiscal year 2001 the level of funding
for each Center is $347,000. These Centers provide for
interdisciplinary training, community services, research and technical
assistance and information/dissemination activities. The University
Centers are affiliated with medical schools, health care centers and
hospitals. They are committed in furthering the health care needs of
this population. For example, University Centers must now report on the
progress they have made on increasing the number of health care
providers trained to meet the needs of people with developmental
disabilities as a result of program intervention. The interdisciplinary
training programs cover such areas as: medicine, nursing, nutrition,
physical therapy, speech pathology, social work, audiology, bio-
statistics, psychology and education. They also provide community
services on behalf of persons with developmental disabilities,
including individual assessments through clinical service programs and
physician referral programs.
______
Questions Submitted by Senator Tom Harkin
federal mental health funding
Question. Secretary Thompson, President Bush has expressed his
interest in increasing Federal support for people with disabilities,
including those with mental illness, with the announcement earlier this
year of his New Freedom Initiative. How do you reconcile those
expressed good intentions with a budget proposal that level-funds and
even cuts Federal mental health funding?
Answer. The Department of Health and Human Services is just one of
several agencies participating in the New Freedom Initiative, which
will help increase access for and integrate individuals with
disabilities into the community through assistive technologies,
expanded educational opportunities, greater opportunities to enter the
workforce, increased access to community-based care and housing, and
other strategies. Increasing support for mental health services by
leveraging federal mental health dollars through better coordination is
one of many components of this initiative.
Other investments in HHS are also furthering the goals of the New
Freedom Initiative. For example, the fiscal year 2002 budget for the
Office for Civil Rights (OCR) will support an increase in its efforts
to work cooperatively with states to implement the Supreme Court's
Olmstead decision. OCR, the Health Care Financing Administration
(HCFA), the Administration on Aging, the Assistant Secretary for
Planning and Evaluation, the Substance Abuse and Mental Health Services
Administration, the Administration for Developmental Disabilities and
other components within HHS are working together with states to help
them ensure that individuals with disabilities, including persons with
mental disabilities, are provided with services in the most integrated
setting appropriate to their needs. As states implement plans to
provide such services, they will be offering individuals with
disabilities more opportunities to move from institutional settings to
community-based options when community-based care is appropriate.
We are also encouraging States to consider special initiatives for
persons with mental illness as they take full advantage of some of the
new opportunities from HCFA. These include the grants and the Medicaid
Buy-In newly available under the Ticket to Work legislation. They also
include the $70 million new ``Systems Change'' grants announced on May
18, 2001 that Senators Harkin and Specter were instrumental in
crafting.
As you know, Medicaid is one of the most important programs for
people with a mental illness. As an entitlement program, Medicaid
continues to expand as more people need assistance. We look forward to
working with you and focusing the attention of the President's National
Commission on Mental Health to determine if there are additional things
we could do to make Medicaid even more responsive to people with mental
illnesses.
The Substance Abuse and Mental Health Services Administration
budget includes $766 million for mental health services, a reduction of
$16 million primarily for one-time projects which will end in fiscal
year 2001. Even with this reduction, the Programs of Regional and
National Significance will have $39 million available for ``new
activities'' as other projects conclude in fiscal year 2001. In
addition, two-thirds of the individuals with substance use problems
also have a mental illness and many of these individuals will benefit
from the President's budget request for an additional $100 million to
support a Drug Treatment initiative.
center for mental health services
Question. The $16 million cut in funding for the Center for Mental
Health Services would significantly impact the agency's Best Practices
or Knowledge, Development, and Application activities. Could you
discuss how the Administration is proposing to address the need to
disseminate research findings on best practices in mental health
service delivery to practitioners and providers in the field so that
the federal dollars devoted to this very important research are not
squandered?
Answer. The President's budget includes $55 million in the Center
for Mental Health Services to support Best Practices or Knowledge,
Development, and Application activities. Within this amount, SAMHSA
will have $39 million to award in new and competing grants and
contracts for Programs of Regional and National Significance for mental
health best practices in fiscal year 2002. The Center for Mental Health
Services has a strong commitment to disseminating to state and local
communities, providers, consumers and other key stakeholders findings
from the evaluation of its knowledge development programs. The Center
is also dedicated to encouraging the adoption of those practices that
will benefit persons with serious mental and emotional health and
substance abuse problems. To achieve this mission, the Center has
funded several grant programs and contracts that use health
communication and other social marketing strategies that increase
awareness of evidence-based practices and encourage the incorporation
of these practices into everyday service delivery. Specific activities
include national training conferences, workshops, reports, technical
assistance meetings, toolkits, mentorship programs, policy and
leadership academies and the use of advanced computer technology for
dissemination and education.
president's fiscal year 2002 budget proposal
Question. The Community Access Program would be eliminated under
the President's budget. This program was designed to link uninsured and
low-income individuals with health care services in their communities,
including mental health services. The budget summary document points to
increases in funding for community health centers (CHCs) as a more
efficient approach to the problem of the low-income and uninsured not
receiving services for which they are eligible. However, the budget
dedicates this increased funding for CHCs to increasing the number of
facilities in existence, with a goal of 1,200 new centers. How much of
this funding increase will actually be used to address the
fragmentation of public health services for the uninsured and under
insured and to help providers link their uninsured patients with the
services they need. Through the Community Access Program, 76
communities received assistance with improving coordination of care for
the uninsured and under insured. How many communities will receive this
kind of assistance under the President's proposal?
Answer. The Administration is committed to identifying programs
that are carefully designed and proven to bring more Americans who may
not have good access to care into the health care safety net. HHS will
focus on the President's commitment to expand direct health care
services to the uninsured through Community Health Centers (CHC), to
which we are adding $124 million, for a total request of approximately
$1.3 billion. This multi- year Presidential Initiative will increase or
expand Community Health Center and Migrant access points by 1,200 over
5 years and eventually double the number of people served. By targeting
our resources to expand CHCs, millions more Americans will have access
to high quality health care.
The CAP program was created to provide short term assistance to
local communities in order to transition to innovative service delivery
approaches in order to ultimately be competitive within their own
markets. Grantees were required to demonstrate that they were able to
sustain the delivery of services and funding through other public and
private sources on a longer term basis. There are existing funding
resources that would enable communities to achieve similar goals as
CAP. For example, CHC funding already supports the Integrated Service
Delivery Initiative, which provides funding to CHCs to support their
efforts to integrate functions with other centers and safety net
providers in their community. The budget also includes $15 million to
support grants to States to develop designs for providing access to
health insurance coverage to all citizens of the State.
national health service corps
Question. The Administration has proposed no funding increases for
the National Health Service Corps (NHSC), citing that there is no
longer a physician shortage. Instead, the proposal is for target
reforms to better address the mail distribution and to increase
available funds by eliminating the tax on scholarships and loan
repayments. Eliminating the taxation and working on better distribution
is all well and good, but the Administration appears to have overlooked
the fact that the Corps provides funds for nurse practitioners,
physicians assistants, dentists, psychologists and other mental health
provider. The nation, especially Iowa and the other rural states
continue to experience shortages of all of these providers. In Iowa,
there remains a shortage of all of these providers. For example, the
Corps is only able to meet less than 7 percent of the dental and mental
health care needs in Iowa. Furthermore, the nurses in Iowa are going
out into the communities to deliver primary care, but we need more of
them.
How can the Administration rationalize not proposing a substantial
increase in funding for the National Health Service Corps by citing the
lack of a physician workforce? How are the Administration's reforms
going to meet the needs of the uninsured and most vulnerable Americans?
Answer. The National Health Service Corp Presidential Management
Reform Initiative will improve the NHSC's service to America's neediest
communities. The initiative will examine several issues, including the
ratio of scholarships to loan repayments and other set-asides, and will
consider amending the Health Professional Shortage Area definition to
include non-physician providers and J-1 and H-1C visa providers
practicing in communities. These efforts will enable the NHSC to more
accurately define shortage areas and target placements to areas of
greatest need. The NHSC reform initiative will also encourage more
primary health care professionals to participate in the NHSC by making
scholarship funds tax free.
The President's budget includes a request of $126 million, in
increase of $1.05 million over fiscal year 2001. These funds support
NHSC clinicians serving communities, as well as outreach and
development efforts in these communities. The funds will also provide
for recruitment efforts: 265 Federal Scholarships, 286 Federal Loan
Repayment agreements, 350 Federal Loan Repayment extensions, and 217
State Loan Repayment agreements. Since the program's inception, more
than 22,000 clinicians have been providing services to millions of
people in underserved areas. Currently, there are nearly 2,400 NHSC
clinicians practicing in Health Professional Shortage Areas.
community health centers
Question. On April 12, 2000, Governor Bush toured the Grace Hill
Community Health Center in St. Louis. He used that occasion to propose
increasing the number of new community and migrant health centers by
1,200 over 5 years in an effort to double the number of people served
by these centers. The administration budget proposal, however, calls
for 1,200 new ``and expanded'' centers and there is no longer a mention
of doubling the number of people served. Moreover, the proposed
increase of $125 million for fiscal year 2002 falls well short of the
mark needed to increase funding by $3.6 billion over 5 years.
Is the Administration still committed to caring for the uninsured
and most vulnerable Americans? How is the Administration proposing to
reach its budget goal of $3.6 billion over 5 years?
Answer. The President's fiscal year 2002 budget for HRSA includes
nearly $1.3 billion for the Health Centers program, an increase of $124
million above the fiscal year 2001 appropriation. These additional
funds will allow Health Centers to create 200 new and expanded access
points and serve up to 1 million additional patients, almost half of
them uninsured. The added funds represent the first installment of the
Administration's multi-year initiative, which will eventually increase
or expand health center access points by 1,200 over five years and
eventually double the number of people served.
The Administration has also proposed a refundable tax credit to
make health insurance more affordable for individuals and families not
covered by an employer plan nor eligible for public programs.
Finally, the Administration is developing ideas to improve the
insurance options available to lower-income individuals. We are working
with States to more efficiently utilize Medicaid and SCHIP funding to
increase the number of individuals with access to affordable insurance,
encouraging the availability of private group health plan insurance
coverage where possible.
real choice systems change grants
Question. Last year, the Appropriations bill included $50 million
for Real Choice Systems Change Grants. These grants had originally been
included in MiCASSA (Medicaid Community Attendant Services and Supports
Act) to help states reform their long term care systems to allow people
with disabilities to live in their own homes and communities. In
addition, another $20 million for demonstration projects to achieve
this same goal.
HCFA announced the Real Choice funds should be used to develop
public-private partnerships to increase services and supports to people
with disabilities. Will HCFA ensure that people with disabilities,
their representatives and their families are members of the grant-
funded state task forces? Answer. We have tried to be very clear that
Congress expressed its intent for States to develop their proposals
jointly with a consumer task force of broad representation. We will
honor that intent, while simultaneously affording states with
sufficient flexibility in the methods of involvement that they can get
the job done. For example, some states have asked if their existing
ADA/Olmstead planning committee could be used. Where such committees
include broad-based consumer representation, we have answered
affirmatively. HCFA also made the involvement of consumers an important
aspect of its review criteria for the grants. Finally, we made $50,000
``Starter Grants'' available to states in February in order to help
defer some of their initial planning expenses, particularly expenses
associated with stronger efforts to involve people with a disability.
We hope these efforts are successful in helping states achieve a robust
level of consumer involvement.
Question. Would you endorse the continuation of these dollars for
the purpose of funding similar grants -and demonstration projects in
2002?
Answer. No. These grants were designed to be one-time grants to
assist States in their effort to allow people with disabilities to live
in their own homes and communities. We believe that the funding
provided in fiscal year 2000 is sufficient to achieve this goal.
community attendant services and supports
Question. Secretary Thompson expressed strong support for
community-based services for people with disabilities and the elderly
during his confirmation hearing. In Wisconsin, he championed the
FamilyCare program to provide comprehensive long term care services to
people with disabilities and the elderly. In Iowa there has also been
an effort to provide more community-based services to people with
disabilities and the elderly. Just last week, the Iowa Department of
Human Services released a draft of the State's Olmstead plan. And, the
state is implementing the Ticket to Work and Work Incentives
Improvement Act.
Both of these initiatives reflect a strong policy consensus--both
nationally and in Iowa--that people with disabilities should have the
opportunity to live in the community and go to work.
In order to provide people with a real choice to live in the
community, however, many individuals with disabilities and the elderly
need access to attendant services and supports. Many states provide
such services through waiver programs, but they are often not Statewide
or comprehensive in coverage. As a result, people remain inside
institutions or are on long waiting lists for appropriate community
services.
There is a strong policy consensus that our long term care system
is in need of reform. Senator Specter and I are in the process of
drafting a revised version of Medicaid Community Attendant Services and
Supports Act that would provide states increased resources for
community attendant services and other activities that would ultimately
remove the institutional bias of the current Medicaid program.
Is HCFA willing to work with us on this issue? How can the federal
government help states create a Medicaid long term care system that
allows people with disabilities and the elderly the opportunity to live
at home and in the community? Answer. We believe that the stimulus
provided by the Congress in the form of ``Systems Change'' grants to
States in fiscal year 2001, coupled with Department's work to more
expeditiously process and approve waiver applications, will allow
States the opportunity to make additional investments in home and
community-based services. Additionally, we anticipate that this work
will support the emergence of effectively working systems that provide
States the ability to provide cost-effective long-term supports.
______
Questions Submitted by Senator Harry Reid
chronic disease tracking system
Question. Fallon, a small town in my home State of Nevada, is
facing a terrible tragedy. In the last 4 years, 12 children have been
diagnosed with leukemia, eight of them in a single year (2000),
significantly more than would be expected in this small community. The
families are angry and scared and have very real concerns that there
may be some connection between this cluster of cancer and the
environment, but currently neither the Environmental Protection Agency
nor the Centers for Disease Control or other involved Agencies in the
Department of Health and Human Services can offer any answers. Two
weeks ago the Committee on Environment and Public Works held a field
hearing in Fallon, and the witnesses, including representatives of the
Centers for Disease Control, Agency for Toxic Substances and Disease
Control and Environmental Protection Agency, and many State officials,
supported my call for comprehensive disease tracking and rapid response
capability.
We had report language in last year's bill that requested CDC put
together a plan for a chronic disease tracking system that looked at
environmental factors. I look forward to receiving and considering
CDC's report on this in the near future. And, I especially want to
ensure that, as CDC moves toward implementation of its plan, it will do
so in an integrated manner, not parcel the disease tracking network up
into separate silos. I do not want this to become a battle between
fiefdoms, but rather a comprehensive health tracking system to protect
the nation's health.
How are you going to make sure that this tracking system is put
together in a strategic way and establishes a coordinated and
comprehensive network?
Answer. In the fiscal year 2001 appropriations report, CDC was
asked to report back to this committee on plans to respond to the
findings of the Pew Commission. In response, CDC's National Center for
Environmental Health formed three CDC workgroups with membership from
across CDC. The workgroups are in the midst of their work. One
important next step is to begin a dialogue with our federal, state,
local and public partners to further define the core functions of what
a tracking system would do and how it would be implemented. A second
step would be to begin planning to develop guidance and protocols for
responding to disease clusters that may be related to the environment.
CDC will work closely with State and Local Health Departments,
professional organizations, e.g. CSTE, ASTHO, to develop these
protocols and guidance.
Question. Is this a priority? I heard at the hearing last week that
Fallon is not alone, that there are many other communities in the
country that are facing unexplained disease clusters.
Answer. CDC is working diligently with existing funds to define
core functions and develop guidelines so that CDC can provide
leadership to the main organizations who would be involved in this
effort.
subcommittee recess
Senator Specter. Thank you very much, that concludes the
hearing. The subcommittee will stand in recess until 9:30 a.m.,
Thursday, April 26, when we will meet in room SH-216 to hear
from the Secretary, Department of Labor, Elaine L. Chao.
[Whereupon, at 10:08 a.m., Wednesday, April 25, the
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
April 26.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002
----------
THURSDAY, APRIL 26, 2001
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:30 a.m., in room SH-216, Hart
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Harkin, and Landrieu.
ERGONOMICS
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Hearing of the Appropriations Subcommittee on Labor, Health,
Human Services and Education will convene. This special hearing
has been set on the subject of ergonomics.
Preliminarily, I want to note that we had an enormous group
in the corridor. I have not seen a line that extends so far to
Constitution Avenue since Bill Gates Junior came to a hearing
here a couple of years ago. And I was a little mystified to
walk in and see the seats empty here and all of the taxpayers
in the corridor.
And I asked why people hadn't come in and I was told you
were looking for an invitation. Well, let the record show you
don't need an invitation to come to a public hearing. You don't
even have to show your tax receipts.
I'll just take judicial notice or senatorial notice that
you are all taxpayers.
Today's hearing is on a very complicated subject. It has
been convened to try to move the process forward as
expeditiously as possible. I had thought that the issue of
ergonomics was resolved in our conferences on this subject,
which go back many years where we delayed the promulgation of a
regulation and had an enormous number of arguments until the
regulation was supposed to have been final.
But as George Schultz once said, nothing is final in
Washington. And we have what I consider to be an area of
necessary governmental action.
We held an ergonomics hearing when the matter was listed
for revocation. Those Senate floor proceedings came up on short
notice, so we had a hearing with a number of witnesses and
found that the subject was very, very complicated and required
a lot more inquiry.
We have a great many witnesses today. What we are going to
try to do is focus in on questions, with concise testimony from
panelists. We welcome the new Secretary of Labor, Secretary
Elaine Chao. My distinguished colleague Senator Harkin has
arrived, so I will turn to him for an opening statement.
Opening statement of Senator Tom Harkin
Senator Harkin. Thank you very much, Mr. Chairman and
Secretary. It is good to see you again. I am glad to see we
have a good turnout here today for this hearing because this is
an extremely important hearing. And I thank you, Mr. Chairman,
for holding this hearing.
I want to thank also AFL-CIO and the National Academy of
Sciences and all who are here from the science and labor
community for coming to testify today.
First, I want to make as clear as I possibly can how
disappointed I was that Congress and the President took the
extreme action of repealing this very important worker safety
standard.
More than 2 million American workers each year report work-
related MSDs and half of them lose time because of these
injuries. The ergonomic standards would have cut those numbers
drastically. And we are talking about cashiers, nurses,
cleaning staff, assembly workers in manufacturing and
processing plants, computer users, clerical staff, truck
drivers, and meat cutters.
And this is not just a labor issue, it is a women's issue
because women are the hardest hit. Women make up 47 percent of
the workforce. But in 1998, they accounted for 64 percent of
the repetitive motion injuries and 71 percent of reported
carpal tunnel syndrome cases.
A good example is Gloria Boyd from Waterloo. She worked 9
years on the assembly line in a pork processing plant. She has
got carpal tunnel so bad she can hardly pick up anything
heavier than a cup of coffee. Tell her, tell her that we do not
need an ergonomic standard. Someone tell her and tell her
family that, would they.
This is a 15-page rule. And I have seen pictures of people
waving huge stacks of paper around. I have seen pictures of
them holding up big stacks of paper saying, Oh, this is how
burdensome this was; when this is it, 15 pages; 15 pages, not
200.
Second, this was a complaint-based rule and very flexible
according to each workplace and job as a result of exhaustive
studies we know of over a decade. Some of my colleagues kept
calling for more studies of ergonomics and repetitive stress
disorders.
What did we do? We kept authorizing more studies. Another
National Academy of Science has studies in 1997, after two more
before that. Then we continued to want to delay the rule. Well,
the NAS study of the studies, the study of the studies came out
in January.
Once again, the National Academy of Science has found there
is strong scientific evidence that workplace exposures cause
musculoskeletal disorders and they can be prevented. So I am
glad that the National Academy of Science is here today to
present these findings.
What more do we have to do to prove that America's workers
are suffering from these repetitive stress disorders and that
there are reasonable ways to prevent them.
With the attitude that seems to be prevalent around this
town today, I doubt if we could get a hard hat rule through
like we did 30 years ago, no, 40 years ago, 30-something years
ago, get a hard hat rule through. Probably could not even get
that today.
Well, yesterday, Madame Secretary, I understand you
received a petition signed by labor unions, civil rights
organizations, women's groups, occupational health and safety
groups, that urged the Administration to make it a priority to
issue a new ergonomics standard.
It should not be that hard. We have studied it for over a
decade. We have got all the scientific basis on it. The work
has been done.
Madame Secretary, I am told that you yourself said that
work-related repetitive strain injuries account for more than a
third of job injuries. And I think this is a quote from you. I
did not hear it but I read it, that we need a solid
comprehensive approach to new ergonomics rules.
Well, that is an encouraging statement. I want to know why
the standard that was issued was not solid and was not
comprehensive. And I would like to know what you are going to
do and how soon you are going to do it.
It is not enough, I do not think, to say that we are going
to look at this some more. I would like to know a deadline. I
would like to know when. And that is a question I am going to
be asking you is when are you going to set a deadline for
having a new rule.
We have gone long enough. Many of our women, our workers,
are suffering lifetime injuries because we delay and we delay
and we delay and we delay. And we shove it under the carpet,
refuse to deal with it.
So if there are some things wrong with the last rule, I am
more than willing to listen, more than willing to take into
account any problems that may have been in it. But I do not
want to see this as an excuse to delay and delay and delay
longer.
If things need to be fixed, let us fix them. I know the
chairman. He believes in worker health and safety as much as
anyone around here. And I know that we would work together. I
think we could work bipartisanly up here, but not if it just
means we are just going to dribble along year after year after
year and not get anything done.
If we have a deadline and you have got solid suggestions,
we are more than willing to take a look at it. It is 2001. It
is time to put this sad chapter, this very sad chapter in
ignoring the legitimate rights of our people to have a rule
that will protect them, that will encourage businesses to make
the modest minor changes necessary to cut down on repetitive
motion disorders, musculoskeletal disorders in the workplace.
With that, I thank you very much, Mr. Chairman.
Senator Specter. Thank you, Senator Harkin.
Let us refrain from applause. Let us not have any displays
here. Let us approach this hearing on a scientific basis and
try to figure out what the facts are and what the public policy
ought to be.
Let us not have any teams on one side or another. Secretary
Chao, we welcome you here. We are going to limit very strictly
the witnesses because we have enough to occupy more than the
day. Our general rules are 5 minutes. We look forward to what
you have to say.
STATEMENT OF ELAINE L. CHAO, SECRETARY, DEPARTMENT OF
LABOR
ACCOMPANIED BY JOSEPH WOODWARD, ASSOCIATE SOLICITOR, OCCUPATIONAL
SAFETY AND HEALTH ADMINISTRATION
Secretary Chao. Thank you, Mr. Chairman and Senator Harkin,
and other members of the subcommittee. Thank you for inviting
me to testify about the need to reduce musculoskeletal
disorders in America's workforce.
With me today is Joseph Woodward. He is the Associate
Solicitor for OSHA, the Occupational Safety and Health
Administration.
When I testified before the Senate Health, Education,
Labor, and Pensions Committee at my confirmation hearing about
3 months ago, I spoke about the challenges of preparing
America's workforce for the emerging realities of the 21st
century workplace.
The Department of Labor must remain in step with the
dramatic changes in our economy to fulfill its responsibilities
to our workforce. And to meet this goal, I have established
five priorities for the Department.
One, is to ensure the safety of every workplace; Two, to
guarantee an honest day's pay for an honest day's work; Three,
to fight discrimination; Four, to protect workers from coercion
and intimidation; and Five, to make sure that workers'
compensation and pensions are protected.
That first goal listed above, to ensure the safety and
health of every workplace, is my top priority. And it will
remain so throughout my tenure as Secretary of Labor.
But I am also committed to bringing the workforce of the
21st century in step with the needs and realities of our modern
economy. And it is clear that the workplace of today is very
different from the workplace as it existed when the Department
of Labor was created in 1913.
Today's employees are better compensated, better treated
and work fewer hours. They are also better trained, more
productive and more knowledgeable. And we must continue
training a more productive workforce in order to continue
producing a better compensated workforce.
And so in that vein, I cannot resist a brief commercial for
the Department's upcoming 21st Century Workforce summit to be
held at the MCI Center on Wednesday, June 20 of this year. You
are all invited to join us as what is supposed to be and what
promises to be an extremely productive and rewarding day to
talk about training and development for the 21st century
workforce.
The workforce of the 21st century today is not only better
off financially than it was a century ago, it is also far
better off from a safety perspective. In 1913, the year the
Department was founded, the Bureau of Labor Statistics, part of
the Department of Labor, documented 23,000 industrial deaths
among a workforce of 38 million people. This is equivalent to a
shocking 61 deaths per 100,000 workers.
In 1999, the latest year for which figures are available,
the Bureau of Labor Statistics reported 6,023 deaths among a
workforce of 134 million people or fewer than 5 deaths per
100,000; fewer but still too many.
These numbers demonstrate that we have made great strides
in improving worker safety over the last century. And the
Department of Labor as well as our Nation as a whole should be
commended for its commitment to improving worker safety.
But these improvements also demonstrate that the new
century and the new workforce require a new approach to the
safety needs of the American workforce, an approach based on
collaboration and prevention rather than the antiquated
adversarial approach of years past.
OSHA has a finite budget of $425.4 million in fiscal year
2001. Securing the cooperation of employers and employees can
help us to leverage the effectiveness of our resources.
For example, several employers recently shared with us how
they have implemented their own ergonomics programs in
collaboration with their workers, and some with the assistance
of OSHA's consultative services.
The administration asks that OSHA place a greater emphasis
on preventing injuries through compliance, assistance and
cooperation, such as education, training and technical
assistance programs, rather than relying on command-and-control
enforcement.
Because we are in a new century and facing a new kind of
workforce issue, it is very important that the Department of
Labor proceed carefully on the ergonomics question. As we begin
this new century, it is important to bring the stakeholders
together, work on creating a common knowledge base and a clear
recognition of the need for a consensus approach to this issue.
Since the Department has seemingly been looking into this
issue for so long, I think it might be helpful to lay out some
of the history to give everyone a sense of the time line, and
the controversy.
Senator Specter. Madame Secretary, we are interested in the
history but the time is very short. The red light has been on.
Could you summarize. Your full statement will be made a part of
the record.
prepared statement
Secretary Chao. My full statement will be made a part of
the record, as you requested. And I will be more than happy to
answer any questions you have.
[The statement follows:]
Prepared Statement of Hon. Elaine L. Chao
Mr. Chairman, Members of the Subcommittee, thank you for inviting
me to testify about the need to reduce musculoskeletal disorders in
America's workforce. With me today is Joseph Woodward, Associate
Solicitor for Occupational Safety and Health.
When I testified before the Senate Health, Education, Labor, and
Pensions Committee at my confirmation hearing three months ago, I spoke
about the challenges of preparing America's workforce for the emerging
realities of the 21st Century workplace. The Department of Labor must
remain in step with the dramatic changes in our economy to fulfill its
responsibilities to our workforce.
To meet this goal I have established five priorities for the
Department:
--to ensure the safety of every workplace;
--to guarantee an honest day's pay for an honest day's work;
--to fight discrimination;
--to protect workers from coercion and intimidation; and
--to make sure workers' pensions are protected.
That first goal listed above, to ensure the safety and health of
every workplace, is my top priority; it will remain so throughout my
tenure as Secretary of Labor. But I am also committed to bringing the
workforce of the 21st century in step with the needs and the realities
of our modern economy. It is clear that the workplace of today is so
very different from the workplace as it existed when the Department of
Labor was created in 1913. Today's employees are better compensated,
better treated, and work fewer hours. They are also better trained,
more productive, and more knowledgeable. We must continue training a
more productive workforce in order to continue producing a better-
compensated workforce. In that vein, I cannot resist a brief commercial
for the Department's upcoming 21st Century Workforce summit, to be held
at the MCI Center on Wednesday, June 20 of this year. You are all
invited to join us at what promises to be an extremely productive and
rewarding day.
The workforce of the 21st century is not only better off
financially today than it was a century ago; it is also far better off
from a safety perspective. In 1913, the year the Department was
founded, BLS documented 23,000 industrial deaths among a workforce of
38 million people--equivalent to a shocking 61 deaths per 100,000
workers. In 1999, the latest year for which figure are available, BLS
reported 6,023 deaths, among a workforce of 134 million people, or
fewer than 5 deaths per 100,000. Fewer, but still too many.
These numbers demonstrate that we have made great strides in
improving worker safety over the last century. The Department of Labor,
as well as our nation as a whole, should be commended for its
commitment to improving worker safety. But these improvements also
demonstrate that the new century, and the new workforce, require a new
approach to the safety needs of the American labor force, an approach
based on cooperation and prevention, rather than the antiquated,
adversarial approach of years past.
OSHA has a finite budget of $425.4 million in fiscal year 2001.
Securing the cooperation of employers and employees can help us to
realize a substantial return on our resources. For example, several
employers recently shared with me how they have implemented their own
ergonomics program--some with the assistance of OSHA's consultative
services. The Administration asks that OSHA place a greater emphasis on
preventing injuries through compliance assistance and cooperation, such
as education, training and technical assistance programs, rather than
relying on command-and-control enforcement.
Because we are in a new century and facing new kinds of workforce
issues, it is very important that the Department of Labor proceed very
carefully on the ergonomics question. As we begin this new century, it
is important to bring the stakeholders together, work on creating a
common knowledge base and a clear recognition of the need for a
consensus approach to this issue.
timeline
Since the Department has seemingly been looking into this issue for
so long, it might be useful to lay out some of the history, to give
everyone, the Congress and the American people a sense of the timeline,
the controversy, and the activities over the last twenty years. As you
all know, last month, under the Congressional Review Act, Congress
repealed OSHA's ergonomics standard. In signing the repeal, the
President emphasized that this Administration supports activities that
will address the critical challenge of reducing musculoskeletal
disorders.
The repeal is only the latest action in the Department's two-decade
history with this issue, dating back to the hiring of the Department's
first ergonomics specialist back in 1979. You may be interested to know
that that individual remains a valued Department of Labor employee.
Since then, OSHA has been working steadily to determine the best
possible position for the Department of Labor to adopt in order to
ensure the health and safety of the American worker. As the history
shows, the Department and Congress have been operating on a collision
course for a number of years now, and this movement forward without a
consensus has put us in the predicament we are in today. At this point
it would be appropriate to submit into the record a timeline covering
some of this history.
The timeline I have just submitted is very useful in laying out the
history of the ergonomics standard. This history helps demonstrate why
the original standard failed--the rush to action, the lack of
consensus, and the continual forward movement despite repeated
congressional expressions of disapproval. This history makes it clear
why we need to take our time and to achieve a greater level of
consensus before proceeding.
why ergonomics failed
It is vitally important that we avoid a repeat of the last
ergonomics standard. It would be wise to consider the factors that
preceded last month's vote by Congress before charting a new course.
OSHA should not rush when producing a new, comprehensive approach to
ergonomics.
Last year, OSHA was asked to complete promulgation of the previous
standard in an unreasonable period of time. Many have stated that this
was a standard that began in the late 1980's under former Secretary of
Labor Elizabeth Dole. Now, we know that the Department actually began
looking at this issue in 1979. We also know, however, that the new
proposed rulemaking was announced in November 1999 and made final in
November 2000. Within that same 12-month period, OSHA received over
11,000 written comments on this rule, making up 188,547 pages. Piled on
top of each other, these comments and supporting documents would be 78
and a half feet high. In fact, standing on top of this stack without a
safety harness would probably constitute an OSHA violation.
These thousands of pages of documents include complex scientific
and mathematical analyses that only experts can understand. As you can
see, this display illustrates just how complex this issue really is,
and how much interest was generated by the last proposal. The rush to
make the standard final, however, forced OSHA to rely heavily on
contractors to assist in the review of these documents. The government
has a responsibility to listen to the people, especially the regulated
community.
Cost, scope of coverage and state jurisdiction were also concerns
of the previous standard. The disparity between OSHA and private sector
cost estimates approached $100 billion. As a result, the Department
will consider having future cost estimates reviewed by an independent
entity. The previous standard attempted to cover a large number of
businesses. The Department could help lower the overall cost by
focusing on high-risk occupations. State jurisdiction should also be
preserved by permitting States to administer workers' compensation
programs without Federal intervention by OSHA.
department activities since cra
In determining how best to proceed from this point, it is best to
take advantage of the expertise and experience of all parties involved
in the issue. Since becoming Secretary, representatives of unions,
employers, safety and health professionals, Congress, and members of
the medical and scientific communities have all come to the Department
to share their thoughts on how to develop an effective strategy to
further reduce--and eventually eliminate--these injuries. The OSHA
career staff also provided a brief on the tools currently available
under the Occupational Safety and Health Act. I look forward to
continuing discussions about the best method for balancing the needs
and concerns of management and labor while improving the health and
safety of America's workers.
Some of the groups with whom we have met regarding this issue
during my short tenure as Secretary of Labor include:
--The president & workers from the United Commercial and Food Workers
Union
--The AFL-CIO
--The Service Employees International Union
--The United Brotherhood of Carpenters & Joiners
--The United Brotherhood of Teamsters
--The Hotel Employees & Restaurant Employees International Union
--The Frozen Food Association
--The American Occupational Therapy Association
--The Food Marketing Institute
--The American College of Occupational and Environmental Medicine
--The American Society of Safety Engineers
In addition, we have also had extensive and multiple briefings with
the dedicated career staff at OSHA to discuss the Department's
activities and options on ergonomics.
Finally, I would add that I am especially pleased to appear here
before you today. I consider meeting with Congress to be an important
part of listening and learning process on this subject.
One thing is clear from these meetings: there is no consensus on
the ergonomics issue. The stakeholders who have come to the Department
of Labor to discuss ergonomics are coming from completely different
positions, ranging from those who want no action to those who thought
that the previous rule did not go far enough. In fact, after my
testimony, you will hear from a number of other witnesses who I expect
will demonstrate the full range of these widely divergent points of
view. And therein lies the problem. This diversity of opinion suggests
that precipitous action is not the wisest course at this time. If we
want to find more common ground on this issue, we will need to engage
in more discussion and analysis, and we will need more data.
principles
That said, we still do know a lot, and enough to begin thinking
about the kinds of approaches that could work, and more importantly,
the starting point from which we want to launch further activities. If
we are to find common ground, it is important that there is at least
general agreement on certain facts and philosophies before we reengage
in the process that was reversed last month with the passage of the CRA
resolution. A great deal of resources, both in and outside the
Department, went into creating the ergonomics standard. Under the CRA,
the Department is now precluded from producing any standard that would
be ``substantially the same.'' Before we expend valuable--and limited--
resources on a new effort, we should agree on general principles that
the Department will follow in creating a new ergonomics approach that
fits the new 21st century workforce. These principles will provide a
vital starting point for common understanding, a point from which we
can hope to find common ground:
1. Prevention.--Everyone can agree that reducing occupational
injuries is our top priority. Fortunately, there is good news on this
front. Recently, the Bureau of Labor Statistics (BLS) released new data
on job-related injuries and illnesses for 1999. The data show that
there has been a continuing decline in musculoskeletal disorders that
result in employees missing time from work. Employers reported 582,300
such injuries in 1999, down from 592,500 in 1998 and from more than
763,000 in 1993. This 25 percent decline has occurred even though more
Americans were in the workforce. While I'm encouraged by this progress,
I also recognize that musculoskeletal disorders remain nearly one-third
of all work-related injuries. The Department should examine why these
rates continue to decline, even in the absence of a specific ergonomics
standard and while the number of annual OSHA inspections remains
steady.
Clearly, more needs to be done to address the hazards that cause
these injuries. My goal is for the Department to develop an approach
that will focus efforts on preventing injuries before they occur,
rather than simply reacting after workers are hurt. We would much
rather prevent an injury than fine an employer in the aftermath of that
injury.
OSHA has a finite budget of $425.4 million in fiscal year 2001. It
is impossible to inspect every workplace with this limited budget. This
money is more effectively spent, and protects more workers, if it is
focused on prevention efforts. Prevention, education and training are
the most effective methods for providing the maximum amount of
protection to the greatest number of workers.
2. Sound Science.--Any Departmental action should be based on the
best available science and research. In the previous Administration's
rush to issue an ergonomics standard, they acted before the completion
of a National Academy of Science study that would have provided all
stakeholders with more information on the ergonomics standard. In the
future, the Department should make sure that it makes determinations
based on the best available science.
3. Incentive-Driven.--OSHA has stated that 95 percent of employers
are acting in good faith. Employers understand that best safety
practices are good for business and are in the best interests of their
workers. Any approach should be centered on cooperation between OSHA
and employers, rather than an adversarial relationship.
OSHA's efforts with the meatpacking industry over the last 10 years
demonstrate how successful a voluntary approach to ergonomics can be.
In 1990, OSHA published ergonomics guidelines for the red meat
industry, ``Ergonomics Program Management Guidelines for Meatpacking
Plants.'' One of the reasons the Agency chose to publish guidelines for
this industry was the unacceptably high injury rate to its workers--
20.2 cases per 100 employees. Many of these injuries were
musculoskeletal disorders.
Many firms in the meatpacking industry used these guidelines and
voluntarily implemented programs in an attempt to decrease ergonomic
injuries and lower their annual workers' compensation premiums. Over
the last 10 years, the case rate of total recordable injury cases
dropped 39 percent, from 20.2 cases per 100 full time workers in 1989
to 12.3 per 100 full-time workers in 1999. The case rate for injuries
involving days away from work also dropped substantially over this
period, from 6.5 per 100 full-time workers to 2.0--a decrease of 70
percent.
Although these guidelines initially arose from an OSHA enforcement
action, this experience does demonstrate the potential effectiveness of
voluntary, industry-specific ergonomics suggestions, especially in
industries where the prevalence of musculoskeletal disorders is
greatest.
4. Flexibility.--We must recognize the unique nature of individual
workplaces--avoiding an unworkable one-size-fits-all approach. The
comments DOL has received demonstrate that one of the biggest
weaknesses of the failed standard was its universal nature. Every
workplace is different and will need different tools and approaches to
prevent ergonomic injuries.
5. Feasibility.--Small businesses complained that the cost of the
previous standard, estimated by the Department at upwards of $4
billion, and by private sources at up to $100 billion, would have
imposed a crushing burden on them. Small businesses need the Department
to recognize the costs of compliance and the economic constraints faced
by small business.
6. Clarity.--The ergonomics standard took up over 600 pages,
including preambles and appendices in the Federal Register. While the
standard represented only a portion of these, small business owners
faced with the entire 600 pages of supporting documents were
understandably frightened. Small business owners lack the legal
resources to understand what is required to comply with complex
regulations. As a result, any approach to ergonomics must include
short, simple, and common sense instructions for employers and their
employees.
what's next?
The Department of Labor understands that there is some
Congressional interest in addressing ergonomic injuries through
legislation. We ask for your patience. This is a new Administration. We
have made it our priority to review and understand this issue by taking
the time to meet with stakeholders, listen carefully to their concerns
and construct principles that guide us to a comprehensive resolution.
While the Department is making significant progress, it will take time
for us to effectively complete our goal.
Defining the best, comprehensive approach for ergonomic injuries is
not a simple process. Occupational physicians explain that ergonomics
involves soft tissue--including tears, scarring or inflammations, which
can all be generated in places other than the workplace. While the
Department is focused on addressing ergonomic injuries acquired on the
job, determining where a worker developed a tissue strain is still
subject to much debate. There is no set formula. No table exists. There
is no equation that permits us to simply plug in a worker's injury and
instantly determine its history. Because of the great difficulty of
identifying many ergonomic injuries and establishing causality, these
kinds of cases can require more investigative resources than
traditional workplace injury cases.
The Department of Labor wants to work with Congress in charting the
best course of action. The Department is here today because it is
committed to providing necessary protections to workers against
ergonomic injuries. We applaud you, Mr. Chairman, for holding this
hearing, and look forward to working with you and hearing any
suggestions you have for providing a sufficient remedy.
Senator Specter. Well, in the interest of brevity and to
move on to the substantive witnesses, I am just going to ask
you one question with two parts. When do you anticipate having
a regulation finished, and what are the appropriate monitoring
steps during the course of the time line from now until the
date you expect to conclude?
Secretary Chao. Mr. Chairman, I would love to give you a
time line and a deadline. A time line we have a better handle
over. A deadline I do not think would do any one of us any
particular good in trying to accomplish the goal of reducing
ergonomic injuries.
We have seen in the past an artificial deadline
unreasonably imposed would in fact not bring about the result
that we all share. We are all in favor of reducing injuries. I
totally agree with you----
Senator Specter. Well, can you give us a time line? You say
you have a handle on a time line but cannot give a deadline.
Secretary Chao. Well, I think any regulation that goes
through OSHA depending on the scope, the complexity, whatever
the particular----
Senator Specter. Secretary Chao, would you take a look at
the scope and complexity and the history and give us a deadline
or a time line.
Secretary Chao. I am not able to do that, sir. I am sorry.
I am unable to do that. I don't think that is a responsible way
to proceed.
Senator Specter. Senator Harkin?
Senator Harkin. Madame Secretary, I guess what I am hearing
is that this is just going dribble on for another 10 years. Is
it going to be 10 years or 5 years?
Secretary Chao. No, I do not have that kind of plan in
mind.
Senator Harkin. 2 years?
Secretary Chao. Sir, with all due respect, I know that you
would like for me to say a specific deadline. I would be more
than glad to do that if that were a responsible course of
action.
Unfortunately, that is not a responsible course of action
in my eyes. I want to do what is right. And the Department is
unable to come to a definitive deadline. And maybe what we can
do is I will ask, if I could, and I hate to put him on the
spot, but Mr. Joe Woodward is the Associate Solicitor.
Senator Specter. We do not want to put anybody on the spot
and we do not want to have a protracted debate about it.
Secretary Chao. Fine.
Senator Specter. There is a deadline on my term. It is 6
years. There is a deadline on the President's term. It is 4
years. And I do not think it is asking too much when this
subcommittee asks you for a deadline.
What I want you to do, if you will not interrupt me, Madame
Secretary, is to go back to the drawing boards and see if you
can give us some estimate as to when it is going to be
concluded.
Secretary Chao. I will do that. May I just add a few words
please?
Senator Specter. Of course.
Secretary Chao. In my testimony, and I wish that people
would read the testimony, because the testimony was put
together with a great deal of thought and care, not for the
purpose of delaying. Because this testimony really lays out in
depth our concern with the subject, our desire to move forward
in a responsible fashion.
I think one of the problems that has occurred in the past
is that there has not been consensus. And despite repeated
appeals from Congress to the Department on acting in a way that
is responsible to them, those steps have not been taken. And I
am not saying anything bad about the department professionals.
I am saying that there were other forces at work.
And so I think if we were to proceed again without due
consideration of all the various interest groups that are
involved, I do not think we are going to be crafting something
that will be sustainable and that will be longstanding.
Senator Specter. Madame Secretary.
Secretary Chao. We are going to end up exactly where we
were prior to March 20. And that is not what I want. I want to
do what is right.
But I think a consensus of some sort has to be brought
together. I have met with all different kinds of groups. And
the diversity of opinions is truly vast. We have people on one
spectrum who do not want to do anything.
Senator Specter. Madame Secretary.
Secretary Chao. I do not agree with that.
Senator Specter. You are repeating yourself. And we do not
have time for that. Consensus is fine, if you can get it.
Consultation is what you have to do. That can be accomplished
in a time frame.
Around here, we all work under time pressures. We work on a
budget under a time pressure, and we work late, and we have a
vote-a-rama, and we have a schedule on appropriations, and we
have a fiscal year, and we have to meet deadlines.
And consensus is great if you can get it, but there are
many regulations. Most regulations are issued without
consensus. If you could come to consensus, you would not need
to have a Department of Labor or a subcommittee or proceed with
these hearings.
I want to proceed to call the first panel of witnesses.
Senator Harkin, you want one more question. OK.
Senator Harkin. Madame Secretary, since you say you are
going to pursue this----
Secretary Chao. Yes, of course.
Senator Harkin. I had my staff look at your budget.
Secretary Chao. Yes.
Senator Harkin. How much is in your budget that you have
devoted to this effort?
Secretary Chao. We have a total OSHA budget of $425
million.
Senator Harkin. I know what your total budget is. I want to
know how much you have devoted to an expeditious review of and
culmination of the effort to issue a new standard.
Secretary Chao. I do not have that number with me. I will
be more than glad to get it for you.
Senator Harkin. And would you submit that to this
Appropriations Committee.
Secretary Chao. I certainly will.
Senator Harkin. I would like to see how much money and
resources you are devoting to this specific effort.
Second, I have read your statement over. And what I do not
see in your statement, I do not see anything in your statement
that says here is what was really wrong with the rule that was
promulgated, point by point, and here is how we fix it.
Now, could you submit that also for the record. I want to
know precisely what it is in this 15 pages of rules that you
think are wrong and that need to be corrected. Could you submit
that for the record?
Secretary Chao. The Congressional Review Act was the action
that nullified the rule making.
Senator Harkin. I understand that. I understand that.
Secretary Chao. That is not our department. We did not
nullify the rule making. In fact----
Senator Harkin. But you are supporting that. And you are
saying that that was the correct course of action to take. You
are saying it was correct to have thrown this rule out. That is
what you are saying.
Secretary Chao. Well, the rule has been deemed null and
void.
Senator Harkin. Yes.
Secretary Chao. That does not mean that a new rule----
Senator Harkin. But you are saying you support that, do you
not? You support that.
Secretary Chao. The administration supports that and I
support that. Yes. Because I think a consensus, some kind of
consensus is necessary for us to be able to move forward.
Because if we do not find some commonality of interests, the
Congressional Review Act will once again be invoked. And any
new rule will be void and nullified.
Senator Harkin. I think----
Secretary Chao. I am concerned about the workers. If we
want to really find a solution to reduce the injuries, we have
to be able to find----
Senator Specter. I regret interrupting but we have a lot of
witnesses. And I think you have asked an appropriate question
as to what the Secretary disagrees with in the regulations.
We all know what the Congress did. If you would care to
respond to that, we would appreciate it. But we are not going
to have a political debate here.
Secretary Chao. You are right.
Senator Specter. That is what we are not going to do. What
we are going to do is try to identify what can be done to
protect workers. And we have experts here on a wide variety of
subjects that is just staggering, including: work-related
musculoskeletal disorders, work-related MSDs and interventions,
cost benefits and feasibility of economic standards and options
for new ergonomics standards.
You have expressed yourself on consensus, Madame Secretary.
We understand that. Speaking only for myself, if you can get
consensus, that is wonderful. If you cannot, you are going to
have to make a decision as the Secretary of Labor, and then
Congress is going to review that. Those are our procedures.
I would like to call the second panel now: Mr. Fellner, Dr.
Bigos, Dr. Hadler, Miss Seminario, Mr. Evanoff and Ms.
Eberhardt.
Let us begin, Mr. Fellner, with a question as to what are
musculoskeletal disorders, if any, which require Department of
Labor regulation.
STATEMENT OF BARUCH A. FELLNER, ESQ., PARTNER, GIBSON,
DUNN & CRUTCHER, LLP
Mr. Fellner. Senator Specter, it is a pleasure to be before
the committee this morning and to participate in this important
hearing. If I may, before I get to your question, may I put it
in the context of the 5-minute statement that it was my
impression we all had an opportunity to give this morning. And
with respect----
Senator Specter. Yes, you may.
Mr. Fellner. I will certainly respond.
Senator Specter. It would be the committee's preference
that you focus on the subject matter for Panel 1 which I have
just articulated.
Mr. Fellner. And with pleasure. I will focus on that, but I
would like to put it in the context of my statement with your
kind permission, sir.
Senator Specter. I have already given you that. Proceed.
Mr. Fellner. On March 6, the distinguished chairman
convened a special hearing to examine the issues surrounding
OSHA's now rescinded ergonomics standard.
During the course of that hearing, I suggested that the
next step in determining what course the Department of Labor
should take should be an open and honest and exhaustive debate
on the science and economics, a course of action rejected by
OSHA in the prior administration.
We are delighted, we are honored to participate in the
beginning of that process and to be part of such a
distinguished panel of experts.
Given the scope of the issues, this process obviously
cannot begin and end in a single day. We expect that this open
dialogue and hopefully consensus will continue in the
Department of Labor under the able leadership of Secretary
Chao. We do not expect the answers to be easy.
The more one becomes familiar with these issues and their
complexity, the more difficult it becomes to find areas of
common ground.
And I would like to introduce this debate, Mr. Chairman, by
outlining some of the many issues about which there is
considerable disagreement first.
The nature of the problem broadly referred to as
musculoskeletal disorders or MSDs is poorly defined. And
Senator Specter, if I may, the problem and its definition runs
the gamut from the definition of the National Academy of
Sciences of disorder, and that is what we are talking about
today, Senator, musculoskeletal disorders which is an
alteration in an individual's usual sense of wellness. That is
the NAS definition. That is their amorphous definition.
OSHA, on the other hand, has defined musculoskeletal
disorders as injuries and illnesses that affect muscles,
nerves, tendons, ligaments, joints or spinal disks. There is
not even an agreement on how to define the problem much less to
cure it.
Number 2, you will hear extraordinary numbers today from
the non-medical witnesses representing the other side, 1.8
million, 650,000 annually. I agree with those numbers, Senator.
If we are talking about an alteration in a sense of
wellness, there are millions of those. If we are talking about
illnesses, injuries, there are very, very few of those.
Number 3, even the strongest proponents of ergonomics
recognize that work and non-work factors contribute to MSDs.
Let me suggest in the interest of time that if a picture is
worth a thousand words, then I invite the attention of this
committee to two pictures, once again from the National Academy
of Sciences; two pictures which describe the complexity of the
factors and the risk factors that go into musculoskeletal
disorders that include the physiology of the human being, the
psychology of the human being, the mechanical factors to which
he is exposed, the socioeconomic factors that the human being
finds himself into.
And to suggest that one can pluck one factor, the physical
factor out of this kaleidoscope of shards and regulate that one
factor is with all respect, Senator Specter, an impossible task
based upon the science that we presently know.
And speaking of that science, we do indeed have a
distinguished panel. We have brought four eminent medical
doctors and researchers, not representatives of the National
Association of Manufacturers, not representatives of the
Chamber of Commerce, not individuals who are after sound bytes,
but rather the folks that know the science and will address the
science. And the science is insufficient to support an
ergonomic standard as we presently sit.
prepared statement
Moreover, and with this I will conclude, when one is
dealing with the single-most expensive regulation in the
history of the Department of Labor, and may I suggest with
respect the greatest example of microengineering of the
workplace in the history of this republic, the science better
be sound before we proceed.
Senator Specter. Thank you very much.
Mr. Fellner. With that, Senator Specter, I will conclude.
[The statement follows:]
Prepared Statement of Baruch A. Fellner
Distinguished Chairman and members of the Subcommittee, I am a
partner with the firm of Gibson Dunn & Crutcher. Since OSHA's inception
almost 30 years ago, I have practiced safety and health law, having
shaped OSHA's enforcement policy in the Solicitor's Office for its
first decade and settled over 1,000 OSHA citations in private practice.
I am firmly committed to a strong OSHA--one which is actively engaged
in preventing accidents, illnesses and injuries in the workplace. On
March 6, the Chairman convened a special hearing to examine the issues
surrounding OSHA's now-rescinded ergonomics standard. During the course
of that hearing, I suggested that the next step in determining what
course of action the Department of Labor should take should be an open,
honest and exhaustive debate on the science and economics--a course of
action rejected by OSHA under the prior administration. We are
delighted and honored to participate in the beginning of that process
and to be part of such a distinguished panel of experts.
For the past eight years, OSHA has committed enormous resources
with a predisposition toward promulgating an ergonomics standard and
without objectively evaluating the underlying science, the costs, or
the benefits of such a standard. In the recent rulemaking, OSHA hired
more than 20 outside consultants to aggressively advocate its position
and to criticize dissenting comments. The resulting ergonomics standard
was perhaps single greatest experiment in social engineering in the
history of the Department of Labor. The costs of the rule would have
been staggering, and it had no clear scientific support. That standard
is now rescinded.
But now we look to the future. This hearing is the first time there
has been open and honest dialogue regarding the scientific foundations
and economic implications of an ergonomics rule. Given the scope of
these issues, this process obviously cannot begin and end in a single
day. We expect that this open dialogue will continue in the Department
of Labor under the able leadership of Secretary Chao.
We do not expect that answers will be easy to find. The more one
becomes familiar with these issues and their complexity, the more
difficult it becomes to find ``areas of common ground.'' I will
introduce this debate by outlining some of the many issues about which
there is considerable disagreement.
--The nature of the problem--broadly referred to as musculoskeletal
disorders or MSDs--is poorly defined. MSDs encompass a variety
of perceived maladies and complaints that are not even
described with consistent medical terminology. Some define MSDs
as objectively diagnosed ``injury.'' The National Academy of
Sciences characterizes MSDs as ``disorders'' that result in
``an alteration in an individual's usual sense of wellness or
ability to function.''
--Efforts to quantify the problem are hampered by the inherent
difficulty of categorizing such diverse conditions and
complaints. According to the Bureau of Labor Statistics, the
bedrock of the claims that an MSD epidemic exists are
principally based on 6 million employers interpreting one
amorphous category: ``sprains, strains and tears.'' That is a
category that encompasses the traumatic and the cumulative, the
objective and subjective symptoms, the disabling pre-existing
condition that has nothing to do with the workplace and the
workplace incident that aggravates but does not injure. And
almost all of these judgments are made by laymen. This is the
stuff of soundbites, not science, as to the catastrophic state
of ergonomic injuries.
--Even the strongest proponents of a standard agree that work and
non-work factors contribute to MSDs. This NAS table is
particularly helpful in showing the complex web of suspected
influences. There is sharp disagreement, however, about the
relative importance and contribution of these factors. The
conclusions of scientific studies are inconsistent and
difficult to assimilate because they involve so many different
aspects of this multi-faceted issue.
--No single, scientifically validated ``exposure-response''
relationship exists to provide a quantitative basis for a
standard. This is not lead or asbestos, where relative
scientific certainty suggests a permissible exposure limit.
Without this grounding, would-be regulators struggle between
two equally unpalatable alternatives: a vague standard based on
general goals such as a ``material reduction'' or making sure
MSDs are not ``reasonably likely to occur,'' and a more
specific standard based on quantitative goals that lack
scientific support.
--Those who espouse the benefits of ergonomics rely largely on
anecdotal evidence. However, there is a dearth of
scientifically supportable evidence--particularly
scientifically reliable randomized controlled trials--on the
effectiveness of ergonomics programs. When we were all in fifth
grade, we learned the importance of the scientific method; we
seem to abandon that method when we are engaged in social
policy or social engineering. Anecdotal evidence of employee
complaints is unreliable because it may be tainted by factors
unrelated to safety or health. Research must focus on
objectively diagnosed medical outcomes.
--Although the benefits of ergonomic controls are speculative, the
costs are very real. Even the prior Administration estimated
annual costs of more than $4.5 billion, making ergonomics the
second most expensive regulation since OMB began its systematic
review of regulatory impact. OSHA's estimate, moreover, was
based on broad-brush estimates that ergonomic interventions
will cost around $150 per job, when the agency had a long track
record of seeking interventions costing many times that amount.
Industry estimates suggested that the true total cost may
exceed $100 billion, perhaps by many multiples.
As we set about for the first time to conduct an objective analysis
of the science and economics of ergonomics, it is necessary to proceed
without pre-formed notions as to the proper outcome. We hope that the
Department of Labor will produce a detailed formal agency analysis that
objectively and thoroughly considers all the evidence and comes to a
conclusion about the appropriate government response, whether that be a
comprehensive standard, a more narrowly targeted enforcement structure,
a set of guidelines, or no action at all. The complete analysis and
determination could then be published in the Federal Register and
subjected to the open notice and comment process necessary to establish
it as final agency action. When this process is complete, we believe
that OSHA will find the current state of scientific knowledge woefully
inadequate to support anything approaching the type of comprehensive
standard-setting exercise recently rejected by Congress.
Senator Specter. Thank you very much Mr. Fellner. Proceed
now to Dr. Stanley Bigos, Professor of Orthopedics, University
of Washington. Dr. Bigos, the floor is yours.
STATEMENT OF DR. STANLEY BIGOS, PROFESSOR OF
ORTHOPEDICS, UNIVERSITY OF WASHINGTON
Dr. Bigos. Thank you. It is an honor to be here today to
participate in an open examination of a federally mandated
ergonomics rule. As a practicing orthopedic surgeon who deals
with pain, a researcher and medical school professor, I have
studied musculoskeletal problems for years and have engineered
some of the principle studies regarding their causes.
Simply, I believe there is no scientific basis for a
mandatory ergonomic intervention at the workplace to prevent
these nebulous things that have been termed musculoskeletal
disorders and we refer to them as MSDs.
The best science regarding musculoskeletal disorders
suggests ergonomic proposals would actually be detrimental to
the health of American workers by medicalizing many of the
undiagnosable things that we in medicine cannot treat
specifically. And if you cannot diagnose it, how do you prevent
it.
Problems at work are a concern for all of us. We would all
like to make them go away. Unfortunately, there is very little
consensus about how to define these MSDs and have virtually no
reliable data regarding the prevalence.
If we were to rely upon the statistics that OSHA cited in
the final ergonomics rule, we would find that the vast majority
of MSDs consist of discomfort or pain, generally unavoidable
back pain that is a part of life.
I am not saying that this discomfort is imaginary. It is
real. It is very real for the people who experience it. I am
merely pointing out that when we speak about MSDs we generally
are not referring to physical injuries that are associated with
tissue damage that can be prevented or medically altered.
This point was recognized in the World Health Organization
meeting on January 14, 2000, in a scientific group where all
the participants agreed that we cannot continue to include
aches and pains as categorized as injury, arthritis or disease
because it keeps us away from the real goal of helping our
patients.
My point is that many MSDs are nothing more than symptoms
without observable tissue damage. We are limited in medicine.
And because there is no reliable data regarding the prevalence,
it is not at all clear exactly what problem it is we are trying
to regulate.
Even if we could identify the nature and scope of the
problem, there is no clear-cut science to support an ergonomics
intervention. The ergonomics hypothesis is that many MSDs are
caused by certain kinds of repetitive motions in the workplace
and this can be alleviated by ergonomic controls alone. The
problem with this hypothesis is that it is contrary to the best
science available today.
The ergonomic hypothesis relies heavily upon studies that
only generate clues of association without actually studying
the clues to see if there can be an effective mechanism by
which the problem can be prevented.
In light of the overwhelming potential cost of an ergonomic
intervention, no rule should proceed without some evidence of
successful intervention such as based on randomized control
trials. No prospective RCTs at this point can guide us in
altering the physical work conditions as an ergonomic remedy to
the problem.
In fact, the best science available does not support an
ergonomic hypothesis. This is especially true for back
problems.
I directed the award-winning Boeing study that was
summarized in the publications in 1991 and 1992. The study was
of 3,020 aircraft workers at the Boeing factory over a 4-year
period to look at the report of back problems.
We started with a retrospective study that provided us with
clues, and then we studied those clues to see about their
impact on the reported back problems. The non-physical factors
outweighed the physical factors in predicting back problems.
The study found no correlation between heavy lifting and work
activities increasing the report of problems.
In fact, the study found that some employees who routinely
performed heavy lifting jobs in the paint shop, lifting 50
pounds with their arms outstretched like this, totally against
everybody's ergonomic recommendation, and actually found that
because of their--probably because of their high job
satisfaction, they were among the least likely to report
problems.
I also chaired the HCPR Guideline Panel which found no data
through a methodologic process that would support what is being
recommended in the rule.
In conclusion, I believe it is imperative for regulators to
recognize the past ergonomic proposals are not supported by the
best science available.
Let us pretend for a moment that the Food and Drug
Administration has suddenly prescribed a specific drug
mandatory for the treatment of all patients with a particular
problem. Further imagine that the FDA did not know the correct
dosage of the drug as we are stuck with, and does not know what
side effects it might have, and never subjected it to a single
randomized trial. Doctors would then guess the dose or just
accept the strong data----
prepared statement
Senator Specter. Dr. Bigos, your full statement will be
made a part of the record. If you summarize the conclusion, we
would appreciate it.
Dr. Bigos. My point is I doubt that we would do that in
medicine. And the whole point is why should an expensive,
unproven, potentially damaging approach be permitted simply
based upon unfound hypotheses because we are dealing with OSHA
science about the work site rather than the FDA science about
our clinics and our hospitals.
If we had the solutions, they would already be taken.
[The statement follows:]
Prepared Statement of Dr. Stanley J. Bigos
It is a pleasure to be here today to participate in an open
examination of the scientific basis for a federally mandated ergonomics
rule. An open discussion of this nature is long overdue. As a
practicing orthopedic surgeon, a researcher, and a medical school
professor, I have studied musculoskeletal disorders for many years and
have engineered some of the principal studies regarding their causes.
Based on my extensive experience in this area, I believe that there is
no scientific basis for mandatory ergonomic interventions in the
workplace. To the contrary, the best science regarding musculoskeletal
disorders suggests that the ergonomic proposals we have seen in the
past would actually be detrimental to the health of American workers.
Presumably, ergonomics regulation in the workplace is intended to
prevent musculoskeletal disorders (MSDs). Unfortunately, there is very
little consensus about how to define MSDs, and as a result there is
virtually no reliable data regarding the prevalence of MSDs in this
country. If we were to rely on the statistics that OSHA cited in its
final ergonomics rule, we would find that the vast majority of MSDs
consist of discomfort or pain--generally unavoidable back pain--that is
a part of life and not accompanied by any observable tissue damage. I
am not saying that this discomfort is imaginary; it is very real to the
people who are experiencing it. I am merely pointing out that when we
speak about MSDs, we generally are not referring to physical
``injuries'' that are associated with tissue damage.
This point was recognized at the January 14, 2000 ``Scientific
Group'' meeting of the World Health Organization, when the whole
conference of 450 participants agreed that musculoskeletal pain is not
equivalent to injury, arthritis or disease.
Because many MSDs are nothing more than symptoms rather than
observable tissue damage, and because there is no reliable data
regarding the prevalence of MSDs, it is not at all clear exactly what
the problem is that we are trying to regulate.
Even if we could identify the nature and scope of the problem,
there is no clear scientific support for ergonomic interventions. The
ergonomics hypothesis is that many MSDs are caused by certain kinds of
repetitive motion in the workplace, and thus can be alleviated by
ergonomic controls alone. The problem with this hypothesis is that it
is directly contrary to the best science that is available today.
The proponents of the ergonomics hypothesis generally rely on
studies that are useful in generating clues about associations, but
that cannot establish the causes of MSDs sufficiently to prevent it. In
light of the overwhelming potential costs of ergonomic intervention, no
rule should proceed without some true evidence of successful
intervention such as a based on randomized controlled tests (RCTs). No
prospective RCTs have ever been conducted to assess the effectiveness
of altering physical work conditions as an ergonomic remedy.
In fact, the best science available regarding the causes of MSDs
suggests that the ergonomics hypothesis is wrong. I directed The award
winning Boeing Study, ``termed sentinel science'' that was summarized
in publications in 1991 and 1992. The Boeing study was a prospective
cohort study of the reporting of back injury claims (not merely
complaints) among 3020 aircraft workers at the Boeing facility over 4
years following a retrospective analysis of back injury claims. That
study found that non-physical factors outweighed physical factors in
predicting the report of back problems at work. The study found no
correlation between heavy-lifting work activities and increased
reporting of back problems at work. In fact, the study found that some
of the employees who routinely performed heavy lifting (paint shop) but
who had high job satisfaction were among the least likely to report
back problems at work.
I also chaired the panel of experts that produced the Agency for
Health Care Policy & Research (AHCPR) Guidelines for Low Back Problems,
which was published in 1994. The AHCPR Guidelines were produced by a
panel of experts brought together under the direction of the U.S.
Department of Health and Human Services to conduct an exhaustive
methodological review of the existing literature on the back problems.
The panel evaluated more than 10,000 abstracts and obtained more than
4,600 studies for methodological evaluation. Based on that review, the
evidence suggested that continued activity rather than decreased
activity would be helpful in alleviating many types of back problems--a
finding that is directly contrary to the ergonomics hypothesis--and the
panel found no valid evidentiary support for the use of ergonomics
interventions to treat or prevent back pain. The AHCPR Guidelines have
since been followed and updated in over 45 countries, including the
United Kingdom, Australia, and Israel. Subsequent research has only
strengthened many of the key findings of the AHCPR panel.
In conclusion, I believe it is imperative for regulators to
recognize that the ergonomic interventions that have been proposed in
the past are not supported by the best science available, and there is
a considerable body of evidence which suggests that certain ergonomic
interventions may actually be physically harmful to American workers
and slow their return to productive life.
Let us consider for a moment the Food and Drug Administration,
which is explicitly charged with evaluating healthcare interventions.
Imagine that evidence-based medicine had demonstrated no support for an
expensive experimental class of drugs designed to treat heart disease.
Imagine that, nevertheless, the FDA suddenly prescribed a specific drug
as the mandatory treatment for all patients. Further imagine that the
FDA did not know the correct dosage of the drug, did not know what side
effects it might have, and never subjected it to a single randomized
control trial. Doctors would guess the dose and accept opinion that
strongest data about the issue is wrong? I doubt it! The medical
community would never be permitted to do this. Why should an expensive
unproven and potentially damaging approach be permitted simply based
upon unfounded hypotheses because we are dealing with OSHA's science
about the worksite rather than the FDA's science about the clinic or
hospital?
Senator Specter. Thank you very much, Dr. Bigos. Dr. Nortin
Hadler, Professor of Medicine and Microbiology/Immunology,
University of North Carolina, Chapel Hill.
STATEMENT OF DR. NORTIN M. HADLER, PROFESSOR OF
MEDICINE AND MICROBIOLOGY/IMMUNOLOGY,
UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL
Dr. Hadler. Good morning. I want to express my gratitude to
the members of the subcommittee for the opportunity to address
you today on issues with which I have grappled as a clinician
and clinical investigator for over 25 years.
I am a rheumatologist and therefore committed to caring for
patients with musculoskeletal disorders. As an academician and
clinical investigator, I was drawn early on to improve our
understanding of the plight of those amongst us who are
otherwise well but in the course of our usual life activities
face compromised function because a particular anatomical
region such as our low back or arm is painful to move.
I coined the term ``regional musculoskeletal disorders'' to
denote this morbidity nearly 20 years ago. Gainful employment
is one realm in which function is placed at risk by a regional
disorder. That is the so-called MSD in OSHA's terminology.
But the illness of work incapacity is not the only
morbidity, nor is the workplace the only context relevant to
the regional disorders. The fact the working capacity from the
regional disorders has engendered ergonomic-based regulatory
efforts is a social construction that bears very close
scrutiny.
We have access to a compelling science that suggests such a
social construction deprives the hurting worker of insights
that could lead to substantive relief. Hopefully, such an
understanding will emerge during the course of today's hearing.
In this, the first of my two presentations, I will focus on
the following aspects of the epidemiology of the regional
disorders: Who is at risk, how common is the morbidity, what
are the options for coping, and what drives the choice amongst
the options.
Notice that I continue to use the term regional
musculoskeletal disorder. I am willing to specify the region,
the knee or low back or neck or shoulder and the like, but
seldom am I willing to apply a label that suggests I know what
is hurting.
For nearly all the regional disorders, there is no way
today to general confidence that any anatomically exact label
is valid. Nearly always there is nothing to see or feel. All
our wonderful techniques for imaging anatomy seldom shed any
light. Either no pathology is demonstrated or that which is
demonstrable is nonspecific.
It is commonly found in age matched individuals who are not
hurting, is likely to have been present in the person who is
hurting before the onset of pain, and likely to persist when
the pain has remitted.
Regional musculoskeletal pain is an intermittent and
remittent predicament of life for all of us. It is distinctly
unusual to live a year without having had to cope with a
backache or 3 years without having to cope with arm pain.
We know this from surveys where volunteers keep diaries of
the morbidity they experience each day and from surveys where
recall of the disorders is elicited. The response varies
depending on how the questions are asked, but the message is
inescapable. Regional musculoskeletal pain is an intermittent
and remittent predicament of life.
In the past decade, there have been a number of
investigations which explore the fashion in which people cope
with these episodes. Coping does not occur in a vacuum. Common
wisdom and advice abounds, as do many purveyors of putative
remedies.
For most of us, most of the time, we can and do cope
according to our fashion. For most of us, most of the time, the
predicament passes and it is not even memorable. What makes it
memorable. What causes us to seek care from a provider. If you
think the answer relates simply to the severity of the pain,
you need to be disabused.
Aspects of life that confound coping render the
musculoskeletal disorders more memorable and less tolerable.
Measures of feeling undervalued, of being undervalued, of
feeling disaffected, and of self-reported health status
associate with the likelihood of remembering and seeking care
for back, knee or arm pain. We have known for decades the
measures of the severity of the pain itself correlates less
well or not at all.
No doubt there is the exceptional person who is faced with
a regional disorder of such intensity and persistence that it
overwhelms all attempts to cope. Such a person deserves the
empathetic care that we would offer anyone with any other of
life's morbid challenges such as a severe case of the flu. But
these are unusual circumstances.
Most people either on their own or with guidance discover
ways to circumvent the painful use of the region that is
hurting until in days, occasionally weeks, rarely months, the
disorder remits sufficiently that life goes on and the episode
is soon to be forgotten.
When someone finds the disorder insurmountable or even
unforgettable, it is likely that coping was confounded by the
psychosocial context in which the morbidity was suffered. These
psychosocial aspects of life operate to render the episode
memorable, to cause one to register the complaint to a health
officer inside or outside the workplace.
This is not to dismiss the backache or the regional arm
pain as trivial or to belittle the effort involved in coping.
We will all face such challenges and hopefully we will all have
the wherewithal to cope effectively. But I can assure you, if
you are trying to cope with a backache and your life is not in
order, if there are coincident challenges at home or work, then
the backache will seem the last straw.
prepared statement
Senator Specter. Dr. Hadler, your full statement will be
made a part of the record. Can you summarize in conclusion
please.
Dr. Hadler. Yes. The conclusion will come in my second
statement. There is absolutely no information as to whether we
can alter the likelihood that we will suffer our regional
disorder. There have been attempts to alter the likelihood that
we will not cope on our own. And the best data we have say such
attempts are ineffective. Thank you for your attention.
[The statement follows:]
Prepared Statement of Dr. Nortin M. Hadler
When I was a medical student, epidemiologists observed that the
risk for Down's Syndrome, trisomy 21, was not uniform in sibships. The
youngest child was more likely to be afflicted with this congenital
disorder. That lead to hypotheses and research as to what was it about
the multiparous uterus that caused the fertilized egg to divide
abnormally.
Several years later, epidemiologists returned to this issue to test
whether they had missed the real association. The younger the child,
the older the mother. Could it be that the likelihood of bearing a
child with Downs's syndrome associated more with maternal age than
birth rank? The answer proved to be yes. The old hypothesis was
superseded and research shifted to the biology of the aging ovary.
Several years after that, epidemiologists again returned to this
issue to test whether they had missed the real association. The older
the mother, the older the father. Could it be? The answer was yes and
no. The likelihood of bearing a child with Down's syndrome associated
with both maternal and paternal age. The old hypothesis was superseded
and research shifted to the biology of the aging ovary and testis.
Such is the scientific method. We learn from the old hypotheses and
the old false starts. And we move on. Today, no one would consider
studies of the microenvironment of the multiparous uterus as relevant
to the pathogenesis of Down's syndrome.
For over 60 years science has sought associations between the
physical demands of tasks and the likelihood of suffering disabling
regional back pain. For 30 years, there have been parallel studies
between physical demands of tasks and disabling arm pain. Associations
have been found, but they are inconsistent and weak. There were hints
30 years ago,\1\ but science has really risen to the challenge in the
past decade, the challenge of asking whether a more important
association was being ignored. I have reviewed this transition in a
lengthy editorial in the Journal of Occupational and Environmental
Medicine last fall \2\ titled ``Comments on the ``Ergonomics Program
Standard'' proposed by the Occupational Safety and Health
Administration'' which I have submitted with the written version of
this statement. I review the number of cross-sectional and longitudinal
studies that have attempted to probe for associations between disabling
regional back or arm pain and aspects of BOTH the physical content of
tasks and psychosocial context of work. Designing such studies is
demanding. How do you measure either physical or psychosocial exposures
given the enormous temporal variability and individual differences? You
do the best you can. The result of these multivariate studies is that
the associations with the physical content of tasks are weaker and even
more inconsistent. The associations with the psychosocial context of
work are also weak, but they are more consistent and generally subsume
the associations with the physical content of tasks.
---------------------------------------------------------------------------
\1\ Hadler, NM. Workers with disabling back pain. N Engl J Med
1997;337:341-3.
\2\ Hadler, NM. Comments on the ``Ergonomics Program Standard''
proposed by the Occupational Safety and Health Administration. J Occup
Environ Med 2000;42:951-969.
---------------------------------------------------------------------------
I could belabor this new literature; it deserves scrutiny. However,
I can not applaud the insistence on relying on the older literature in
the systematic reviews that are promulgated by NIOSH and the NRC. Any
study that considers only the association between the physical demands
of tasks and the likelihood of a disabling regional musculoskeletal
disorder is out of date, even if it is on-going or proposed. The state-
of-the-science has moved beyond the testing of that hypothesis to newer
hypotheses that promise to be more informative.
Let me illustrate first with two small area analyses. There are
large companies that have multiple work sites each with similar
facilities and similar demographics of the workforce. The incidence of
disabling back or arm pain varies from site to site, sometimes
dramatically. That offers the opportunity to explore whether measurable
differences in task content, demographics or psychosocial context
associate best with the variability in the incidence of disabling
regional musculoskeletal disorders. Independently, investigators from
NIOSH and I performed such a small area analysis in US West directory
assistance operations.\3\ \4\ \5\ Neither the NIOSH investigators nor I
could explain the site-to-site variability in the incidence of
disabling arm pain by any aspect of task content. However, multiple
aspects of the psychosocial context of work did associate, fear of
redundancy, work pressure, and lack of decision authority to mention a
few. Interestingly, the more overtime and the more hours spent at the
computer, the LESS likely the operator was to have found arm pain
disabling.
---------------------------------------------------------------------------
\3\ Hadler NM. Arm pain in the workplace: a small area analysis. J
Occup Med 1992;34:113-9.
\4\ Hales RR, Sauter SL, Peterson M, et al. NIOSH health hazard
evaluation report (HETA 1989-299-2230, U.S. West Communications).
Washington, DC: Department HSS, PHS, CDCP, NIOSH.
\5\ Hales T, Sauter SL, Peterson MR, et al. Musculoskeletal
disorders among visual display terminal users in a telecommunications
company. Ergonomics 1994;37:1603-21.
---------------------------------------------------------------------------
Another small area analysis was performed by UPS. The results were
submitted as part of the rules making process regarding OSHA's
``Ergonomics Proposed Standard'' last year. A detailed ergonometric
analysis was performed at a number of UPS hubs where the tasks involve
the sorting of parcels. There is not even a hint of an association
between physical task demands and the likelihood of recorded disabling
arm or back pain.
What do I mean by impugning the psychosocial context of work? What
is the human implication of these small area analyses and nearly all
multivariate cross-sectional and longitudinal studies that detect
associations with the psychosocial context of working \6\ \7\ \8\ \9\
\10\ \11\ and the likelihood of reporting to a health officer in the
workplace that your regional arm or back pain is disabling? I do not
mean to impugn the veracity or the motivation of any worker so
afflicted. Nor am I suggesting that the inflammatory social
construction, ``It's in your head'' pertains. I believe they hurt and I
am saddened that their pain is insurmountable. I know that the remedies
offered by the providers of today are no matches for this dilemma; \12\
\13\ at best they are minimally helpful, most are useless and offer the
specter of iatrogenesis. However, the science of today forces me to
conclude that their back or arm pain is rendered incapacitating because
elements of the psychosocial context in which they work impede coping.
The frontier for epidemiology is to further define ``psychosocial
context.'' That's a daunting exercise.\14\ Some of the common threads
emerging from studies in the workplace include aspects of job
``stress,'' \15\ ``strain,'' \16\ ``allostatic load'' and motivational
``flow.'' \17\ These measures are sampling such complex psychological
functions as satisfaction, autonomy and security on the job as well as
perceived psychological demand, motivation, collegiality, and the like.
No wonder, associations with ``psychosocial'' variables are weak, even
inconsistent. There may be much that is idiosyncratic. However, that
does not diminish the implications. The sad fate of the hurting
worker(s) is predetermined if he or she, or they are trapped in a
malignant psychosocial milieu.
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\6\ Linton SJ. A review of psychological risk factors in back and
neck pain. Spine 2000;25:1148-56.
\7\ Marmot M. Importance of the psychosocial environment in
epidemiologic studies. Scand J Work Environ Health 1999;25(suppl 4):49-
53.
\8\ Heliovaara M. Work load and back pain. Scand J Work Environ
Health 1999;25:385-6.
\9\ Krause N, Ragland DR, Fisher JM, Syme SL. Psychosocial job
factors, physical workload, and incidence of work-related spinal
injury: a 5-year prospective study of urban transit operators. Spine
1998;23:2507-16.
\10\ Burton AK. Back injury and work loss. Biomechanical and
psychosocial influences. Spine 1997;22:2575-80.
\11\ Papageorgiou AC, Macfarlane GJ, Thomas E, Croft PR, Jayson
MIV, Silman JA. Psychosocial factors in the workplace--do they predict
new episodes of low back pain? Spine 1997;22:1117-1142.
\12\ Hansson TH, Hansson EK. The effects of common medical
interventions on pain, back function, and work resumption in patients
with chronic low back pain. Spine 2000;25:3055-64.
\13\ Van Tulder MV, Koes BW, Bouter LM. Conservative treatment of
acute and chronic nonspecific low back pain. A systematic review of
randomized controlled trials of the most common interventions. Spine
1997;22:2128-56.
\14\ Davis KG, Heaney CA. The relationship between psychosocial
work characteristics and low back pain: underlying methodological
issues. Clin Biomechanics 2000;15:389-406.
\15\ Israel BA, Baker EA, Goldenhar LM, Heaney CA. Occupational
stress, safety and health: conceptual framework and principles for
effective prevention interventions. J Occup Health Psychol 1996;1:261-
86.
\16\ Karasek RA, Theorell T. Healthy Work. New York:Basic Books,
1990.
\17\ Guastello SJ, Johnson EA, Rieke ML. Nonlinear dynamics of
motivational flow. Nonlinear Dynamics, Psychology, and Life Sciences
1999;3:259-73.
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There are 4 cohort studies that bear witness. Two are ``natural''
experiments in that a captive workforce was followed through an
interval when the psychosocial environment was purposely perturbed: In
the early 1990's, the Finnish economy suffered a considerable setback
lasting several years. Many workers were dismissed. The effect of
impending downsizing on the local-government employees in one small
city was monitored.\18\ The rate of absenteeism escalated, most
markedly for sick leave ascribed to regional musculoskeletal disorders,
particularly among employees over the age of 50.
---------------------------------------------------------------------------
\18\ Vahtera J, Kivimakl M, Pentti J. Effect of organisational
downsizing on health of employees. Lancet 1997;350:1124-8.
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The ``Whitehall'' studies are cohort studies of British civil
servants that long ago documented an inverse relationship between civil
service grade and mortality rate, particularly mortality from
cardiovascular disease. In recent years it has become clear that the
association with grade paled next to the association with psychosocial
job ``stress'', particularly job ``control'', regardless of grade.\19\
Similar relationships with job ``stress'' pertain to sickness absence
from disabling regional back pain.\20\ The ongoing nature of Whitehall
studies made it possible to take scientific advantage of a natural
experiment.\21\ In 1988, the British government announced a major
restructuring. The Property Services Agency was to be ``privatized'' to
which end its function was ``outsourced'' in 1992. These Orwellian
terms fool no one, particularly the thousands of bureaucrats whose jobs
were at risk. They realized that many of them would be without jobs, as
was the fate of 41 percent in 1992, and that employment in the private
sector was predictably insecure. What they couldn't have foretold was
that their health would deteriorate during the 3 years anticipating
``downsizing'' and sick leave would escalate. None of the trends could
be ascribed to health-adverse behavior. Impending downsizing wreaks
havoc on the psychosocial context of work inflicting ``stress'' and
``strain'' on all.\22\ Downsizing accelerates that noxious,
insalubrious, and lethal process we are denoting as an adverse
``psychosocial'' work context. And it does so without regard for prior
station in life.
---------------------------------------------------------------------------
\19\ Bosma H, Peter R, Siegrist J, Marmot M. Two alternative job
stress models and risk of coronary heart disease. Am J Public Health
1998;88:68-74.
\20\ Hemingway H, Shipley MJ, Stansfeld S, Marmot M. Sickness
absence from back pain, psychosocial work characteristics and
employment grade among office workers. Scand J Work Environ Health
1997;23:121-9.
\21\ Ferrie JE, Shipley MJ, Marmot MG, Stansfeld SA, Davey Smith G.
An uncertain future: the health effects of threats to employment
security in white-collar men and women. Am J Public Health
1998;88:1030-6.
\22\ Reissman DB, Orris P, Lacey R, Hartman DE. Downsizing, role
demands, and job stress. J Occup Environ Med 1999;41:289-93.
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Even without the inflammatory influences of downsizing, an adverse
psychosocial context works its harm. Slowly it will deprive one of
favorable ``self-rated health'' (SRH). Like socioeconomic status, SRH
is a powerful predictor of all-cause mortality, let alone the
likelihood that one will seek care for regional musculoskeletal
disorders.\23\ In a cohort of 5,001 Danish workers, adverse
``psychosocial'' work context was shown to erode SRH over the 5 years
of observation.\24\ A similar association has emerged from analysis of
the nurses' health study; a perception that psychosocial work
conditions were unfavorable predicted declining functional status among
some 21,000 nurses followed for 4 years.\25\
---------------------------------------------------------------------------
\23\ Croft P, Schollum J, Silman A. Population study of tender
point counts and pain as evidence of fibromyalgia. BMJ 1994;309:696-9.
\24\ Borg V, Kristensen TS, Burr H. Work environment and changes in
self-rated health: a five year follow-up study. Stress Med 2000;16:37-
47.
\25\ Cheng Y, Kawachi I, Coakley EH, Schwartz J, Colditz G.
Association between psychosocial work characteristics and health
functioning in American women: prospective study. BMJ 2000;320:1432-6.
---------------------------------------------------------------------------
There are many lessons from the century of disabling regional
backache.\26\ \27\ Most germane to our discussion today, there is no
ergonomic solution. Ergonomics has a role in designing workplaces that
are comfortable when we are well and accommodating when we are ill or
aging. But ergonomic interventions will not decrease the likelihood
that a worker will find his or her next episode of regional
musculoskeletal pain disabling. And an ergonomic regulation of the kind
recently proposed by OSHA will certainly prove harmful: Such a
regulation will medicalize the workforce; no longer will it seem
reasonable to cope with back or arm pain without demanding remedies
that, for the moment, do not exist. It will perpetuate the sophism that
task content is the culprit, and thereby inflame resentment. It will
lead to task modifications that have never been shown to be helpful.
And most importantly, the regulations enforce a sophistical social
construction so that progress in science or policy is impeded.
---------------------------------------------------------------------------
\26\ Hadler NM. Laboring for longevity. An annotated poem. J Occup
Environ Med. 1999; 41:617-21.
\27\ Hadler NM. Occupational Musculoskeletal Disorders. Second
Edition. Philadelphia, Lippincott Williams & Wilkins. 1999. Pp. 1-433.
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We know better.
Thank you for your attention.
Senator Specter. Thank you, Doctor. Turn now to Ms. Peg
Seminario, Director of the Department of Occupational Safety
and Health, AFL-CIO.
STATEMENT OF PEG SEMINARIO, DIRECTOR, DEPARTMENT OF
OCCUPATIONAL SAFETY AND HEALTH, AFL-CIO
Ms. Seminario. Good morning, Mr. Chairman and Senator
Landrieu. Thank you for the invitation to testify today. I am
Peg Seminario, Director of Safety and Health for the AFL-CIO.
A couple of points. Work-related musculoskeletal disorders
are a huge problem in the workplace today. We have heard the
statistics referred to earlier today, one-third of all serious
workplace injuries.
The latest Bureau of Labor Statistics' survey showed
582,000 of these cases that were serious enough to result in
time off the job. Those come from employer reports. Those are
not the AFL-CIO's numbers. Those are not even the Department of
Labor's numbers. Those come from employer reports.
And I think if you talk to individual employers, they would
confirm that is what they see. I believe a statement was
submitted to the record of this hearing by ALCOA by the
steelworkers in ALCOA which said that for ALCOA that one third
of all of their workplace injuries are musculoskeletal
disorders. And in some sectors such as the auto industry and
meat packing, it is even greater. And what we have also found
is that these numbers really underestimate the problem.
We did a comparison looking at Workers' Compensation data
and Bureau of Labor Statistics' data thinking that we would
find more cases on the OSHA log. What we found is there were
more cases compensable, even though the criteria for
compensation are much greater. We found twice as many cases in
compensation than even under OSHA.
So this is a huge problem for workers across the United
States. It is a huge problem for employers. And I am always
struck by coming to a forum such as this and all the work we
have done over the last 10 years that what I hear from Mr.
Fellner, Dr. Bigos and Dr. Hadler, it does not bear any
relationship to the world that we know, the workplaces we know.
There are a number of workers who have come to this hearing
today who were with us yesterday as well. These people love
their jobs. I mean, they really care about their jobs.
Cindy Wright is a nurse's aid who was with us yesterday,
suffered a very, very serious injury, rotator cuff problem,
neck problem, from lifting a very heavy patient in a nursing
home.
She is crushed that she cannot go back to work. This is not
about coping. She is injured. She is in pain. She needs help.
This injury could have been prevented if they had used a
mechanical lifting device. But Dr. Hadler would have you
believe that, no, she just needs to cope better or she needs to
like her job better.
This is not the case. These are very significant serious
injuries to workers. Again, they occur throughout all sectors
of the economy. They are upper extremity problems, which as you
have heard are a particular problem for women workers.
They are problems of the low back, heavy lifting,
repetition, awkward postures, vibration. We know the exposures
that cause these problems. And what we have seen is that when
employers put in place programs that evaluate these hazards,
reduce exposure, yes, indeed, we see reductions in injuries.
That is what we see. That is the real world.
You can talk about whether there is consensus on this.
Clearly as you have heard this morning there is not. But we
would agree with Senator Specter that if we had waited for
consensus on whether asbestos caused cancer, whether benzine
caused leukemia, whether cotton dust caused byssinosis, we
would still have workers in this country dying and being
exposed today of these very, very serious hazards. And so there
may not be consensus but there is evidence.
I think if the committee looks at the reports of the
National Academy of Sciences done in 1998, the recent report
concluded in 2001, you will see that they are very
comprehensive documents that involved a lot of folks, a lot of
experts. The experts in the country, over 50 experts involved
in the developments of those reports, they came to some very
firm conclusions. And we would encourage you to look at those
conclusions.
Let me just say that there are approaches to dealing with
these problems which we will talk about later today, but just
to make the point that these are very real injuries. They are
significant injuries. They disable a lot of workers in this
country.
prepared statement
This problem really needs a national response. And we are
glad that Senator Specter is having this hearing to examine
this issue so completely and that both Senator Landrieu and
Senator Specter are on legislation directing the Department of
Labor to issue a standard. Thank you.
[The statement follows:]
Prepared Statement of Peg Seminario
Mr. Chairman, members of the committee, my name is Peg Seminario. I
am Director of Safety and Health for the AFL-CIO, a federation of 65
national and international unions representing 13 million working men
and women and their families. I appreciate the opportunity to testify
at this special hearing on ergonomics and to present our views on why
an OSHA ergonomics standard is urgently needed to protect workers in
this country.
The AFL-CIO has a long and deep interest and involvement in the
ergonomics issue. Musculoskeletal disorders (MSDs) caused by exposure
to ergonomic hazards are a major safety and health problem for our
members and for all workers. In all economic sectors and in most
industries, musculoskeletal disorders are the major source of workplace
injury and illness. Workers in meatpacking, poultry, auto assembly,
nursing homes, transportation, warehousing, construction, agriculture
and data entry are among those at risk.
For more than two decades, unions have been working hard to prevent
these injuries through research, joint efforts with employers, union
training programs, and by requesting OSHA enforcement actions under the
general duty clause.
Since the late 1980's, we have been seeking an OSHA standard to
prevent unnecessary musculoskeletal disorders and to control ergonomic
hazards. It has been ten years since former Secretary of Labor
Elizabeth Dole committed the Department of Labor to ``taking the most
effective steps necessary to address the problem of ergonomic hazards
on an industry-wide basis'' and to develop an ergonomics standard. But,
due to fierce industry and political opposition to any mandatory
ergonomics standard, today workers have no legal protection against
these hazards. During the past decade millions of workers have suffered
unnecessary injury, illness and disability while an ergonomics standard
has been delayed. More than 4,900 workers are injured each day that
protections are further delayed. Since the OSHA ergonomics standard was
repealed on March 21, 2001, more than 170,000 workers have suffered
work-related musculoskeletal disorders.
work-related musculoskeletal disorders are the nation's leading job
safety problem
Work-related musculoskeletal disorders are the leading type of
occupational injury and illness in America today. These disorders
include upper extremity disorders such as carpal tunnel syndrome,
tendinitis, tenosynovitis, and rotator cuff injuries, and disorders of
the low back.
The Bureau of Labor Statistics (BLS) reports that over 582,000
musculoskeletal disorders involving days away from work were reported
by private sector employers in1999, accounting for more than one in
three of all injuries and illnesses involving recuperation away from
work. (Appendix A) The National Academy of Sciences, in its January
2001 report, found that approximately one million people lose time from
work each year due to musculoskeletal disorders.
While the total number of lost-time MSDs reported by the Bureau of
Labor Statistics has declined since 1992, the problem of workplace MSDs
is still great. Despite the downward trend in total numbers of reported
cases, MSDs have consistently accounted for more than one-third of
total lost worktime cases since 1992. More disturbing, the downward
trend seems to be reversing in some areas. According to the most recent
BLS survey, the rate of injuries associated with repetitive motion rose
from 1998 to 1999 in every industrial sector except finance, and
increased over 9 percent nationally. The rate of injuries caused by
overexertion increased in construction and mining in 1999, and the rate
of illnesses caused by repeated trauma increased from 14.8/10,000
workers to 17.6/10,000 workers in transportation.
These large numbers of injuries reported by the BLS and NAS,
however, do not represent the total scope of the problem. These cases
represent only those injuries and illnesses which result in more than
one day of lost time from work. Based upon the ratio of non-lost work-
time injuries to lost work-time injuries which occur in the workplace,
(2 to 1), the Department of Labor has estimated that a total of 1.8
million MSDs are reported by employers to the Bureau of Labor
Statistics each year.
But even this number understates the magnitude of the problem. The
BLS survey only reports injury and illness data for the private sector.
The injury experience of the more than 16 million state, county and
local public sector workers, and 2.8 million Federal sector workers,
including postal workers, is not reflected in the survey (Employment
and Wage Annual Averages, 1997, BLS, 1998). While comprehensive and
detailed injury data for these groups of workers is not collected, the
data that is available shows that MSDs are a major problem for these
workers as well. For the 28 states and territories where injury and
illness data is collected for state and local public employees, in
1998, the BLS reported 63,374 musculoskeletal disorders that resulted
in lost work days.
There is also extensive evidence that the BLS survey understates
the extent of the MSD problem for private sector workers. More than 16
studies submitted to the record of OSHA's rulemaking on ergonomics
demonstrated significant under recording and under reporting of
workplace injuries. Based on this evidence OSHA found that ``that for
every reported MSD, another MSD goes unreported. Thus, the total number
of work-related MSDs estimated by OSHA to occur in the United States
annually is 3.6 million.'' (OSHA, 2000) This estimate does not include
MSDs suffered by state, local or Federal employees.
A comparison of data from the BLS survey, workers' compensation
data and surveillance data for several states confirms that the BLS
data under-represents the extent of work-related MSDs. A review by the
AFL-CIO of available BLS data and state workers' compensation data on
musculoskeletal disorders for three states--Massachusetts, Oregon and
Washington--for a several year period in the 1990's found that the
numbers of cases of MSDs reported to BLS were significantly less than
the number of MSD cases accepted for workers' compensation--in many
instances 50 percent less. These differences are even more significant
since the criteria for compensation are much more restrictive than the
recording and reporting criteria under the BLS survey (i.e.
compensation for MSDs required 4 or 5 days off the job, compared to one
day of lost time for reporting to BLS). See Appendix B.
Recent studies have demonstrated that only a small percentage of
workers suffering from work-related back injuries, carpal tunnel
syndrome and other musculoskeletal disorders are filing workers'
compensation claims for these injuries. A study published in the
January 2000 ``Journal of Occupational and Environmental Medicine''
found that only 25 percent of the group of Michigan auto workers
studied with diagnosed work-related musculoskeletal disorders filed for
workers' compensation (Rosenman et al, 2000). A similar study of
Connecticut workers found that only 10 percent of workers with
musculoskeletal disorders filed workers' compensation claims (Morse et
al, 1999).
Based upon these studies, it appears that the under reporting of
MSDs may be far greater than found by OSHA in its ergonomics rulemaking
and the true magnitude of work related MSDs far greater than 3.6
million cases a year.
Work-related MSDs are among the most severe injuries facing
American workers. The BLS reports that among major disabling injuries
and illnesses, median days away from work are highest for carpal tunnel
syndrome (27 days). This is significantly higher than the median days
away from work for fractures or amputations.
While MSDs occur in every sector and industry across the economy,
some sectors have been hit harder than others. Over one quarter of all
MSDs involving time away from work occur in the service sector and over
one quarter in manufacturing. Nursing aides, orderlies, and attendants,
along with registered nurses, accounted for almost 10 percent of all
lost time work-related MSDs in the U.S. in 1999. Sixty-five percent of
injuries and illnesses involving days away from work for nursing aides,
orderlies and attendants are due to sprains and strains, while 60
percent of Registered Nurses' injuries and illnesses are due to sprains
and strains.
BLS data show that for many types of MSDs involving the upper
extremities, including carpal tunnel syndrome, women workers suffer a
disproportionate number of injuries. In 1999, women suffered 67 percent
of reported carpal tunnel syndrome cases (18,651) and 61 percent of
reported tendinitis cases (10,127) even though women comprise about 46
percent of the workforce and accounted for 33 percent of total
workplace injuries (BLS, 1999). As with other musculoskeletal
disorders, the number of cases of carpal tunnel syndrome, tendinitis
and other repetitive motion injuries reported by BLS understates the
extent of the problem found among these workers.
Workers in meat packing plants have a repetitive trauma disorder
incidence rate of 912 per 10,000 full time workers. Motor vehicle and
car bodies have a rate of 685.5 and numerous textile and apparel
sectors have rates exceeding 200.
Ergonomic hazards are also a significant problem for workers in
construction, maritime and agriculture. These sectors should be covered
by an OSHA ergonomics standard just as they are currently covered by
standards in the states of California and Washington. According to the
BLS survey, in 1999 there were 52,800 reported cases of lost-time
injuries resulting from overexertion and repetitive motion in these
sectors. These types of injuries accounted for 23 percent of all
reported lost work-time injuries in construction, 21 percent of
reported lost time injuries in maritime (SIC Codes 44 and 373), and 18
percent of reported lost work-time injuries in agriculture. A large
percentage of construction workers suffer from back injuries, shoulder
injuries and other musculoskeletal disorders.
the toll of musculoskeletal disorders on workers and the economy is
great
Musculoskeletal disorders are painful, disabling, costly injuries.
According to the National Academy of Sciences, a conservative estimate
of the costs imposed by MSDs on the American economy is between $45 and
$54 billion every year (NRC/IOM, 2001). These figures only include the
actual monetary losses that result from MSDs, but do not account for
the enormous pain, suffering and disability that these preventable
disorders cause.
The pain and toll of these injuries was described by dozens of
injured workers who testified at OSHA's ergonomic hearings on why a
standard was so important--workers like Ron Kline, an auto worker from
Maryland, Carol Py, a clerk typist from Pennsylvania and Nancy Foley a
newspaper reporter from Massachusetts, all who developed serious work-
related MSDs.
``Starting with my right elbow, the illness became so severe, I
could not lift the air gun. As this was occurring, my reaction was to
start using my left hand to complete my assignment.
``As the pain worsened, even with local treatment from the
dispensary, it required surgery.
``The time away from work for my right arm required 13 weeks away
from work with less than complete recovery, leaving me with 15 percent
permanent loss of full use of my right arm.
``I also endured one year of physical therapy for my right arm.
``Subsequently, I required surgery on my left arm with seven weeks
away from work.'' (Oral testimony of Ron Kline at OSHA Ergonomics
Hearings, Tr. 7950)
______
``I developed cumulative trauma disorder which is like multiple
muscular injuries due to repetitive motion, DeQuervains disease in my
thumb here, cubital tunnel syndrome which is the ulnar nerve,
compression of the ulnar nerve the elbow and trigger finger.
``During the next 12 months, the pain in my hand was so unbearable
that I had to have repeat surgery on my right hand. I have trouble
turning the pages. I never returned to work as my medical restrictions
were so limited that my company could not find me a job.
``Last year, I had surgery on my other hand because my thumb would
not move.
``Today, I have difficulty driving, cleaning, cooking, and food
shopping. And my husband, he mostly does all my shopping for me. And my
grandchildren do a lot of the cleaning for me, too. The yard work is
out of the question since I cannot rake or mow the lawn. I had to give
up the things that I used to love like sewing and gardening. Before I
was injured, I even had a green belt in karate. My arms are so weak now
that I can barely take care of my three grandchildren.'' (Oral
testimony of Carol Py at OSHA Ergonomics Hearings, Tr. 6321-6322).
______
``By the time I left the newspaper I was so severely injured that
my recovery has been very slow. I may never fully recover. I live with
chronic pain every day. Sitting still triggers pain. I have trouble
carrying groceries into my house and doing simple housekeeping tasks. I
am trying to retrain to be a school teacher, but my injuries make the
retraining difficult. I do my school work by lying in bed and talking
into a voice-activated computer.
``I loved my job. I remember thinking how lucky I was to have a job
that was so much fun. It was a great disappointment to me to have to
give it up...I have suffered from severe depression as a result of
losing my career and living with chronic pain. I have lost thousands of
dollars in income. I had hoped to have children some day, but I cannot
pick up and carry my eight-month old niece.'' (Oral testimony of Nancy
Foley at OSHA Ergonomics Hearings, Tr. 7321-22).
The pain and disability caused by musculoskeletal disorders is
widespread. Dr. Robin Herbert of the Mt. Sinai Medical Center, an
occupational physician who testified at the OSHA's ergonomics hearings
reported that 25 percent of her patients with musculoskeletal disorders
have permanent disabilities, and of those 25 percent, ten percent are
never able to return to work (Oral testimony at OSHA Ergonomics
Hearings, Tr. 1736-37). Preliminary results of one study showed that 15
percent of all patients with MSDs of the upper extremities are
characterized as disabled (Oral testimony at OSHA Ergonomics Hearings,
Tr. 1738). In New York State, between 1993-1995, 86 percent of workers
with carpal tunnel syndrome were deemed to be permanently disabled by
workers' compensation judges (Herbert, 1999). A study of workers'
compensation claims for ergonomic injuries in North Carolina found that
19.4 percent of the injuries resulted in permanent partial disability;
22 percent of the claimants were unable to return to work (Waldorf and
Snow, 1996).
The financial and social consequences of these injuries on workers
are significant. Many injured workers receive no workers' compensation.
Their injuries and disabilities destroy or severely limit their ability
to make a living. Financial burdens created by these injuries result in
workers losing their homes, cars and health insurance. Injured workers
are often unable to lead a normal life experiencing great difficulty
performing routine activities such as writing, cleaning, caring for
children, bathing and driving a car. The effects of these injuries on
injured workers' well-being is also significant. Workers suffering MSDs
report higher levels of depression, anxiety and stress at home.
the scientific evidence in support of an ergonomics standard is
extensive and strong
A broad, extensive, and overwhelming body of scientific evidence
firmly establishes that musculoskeletal disorders are caused by
exposures to workplace ergonomic risk factors--force, repetition,
awkward postures and vibration. This conclusion is strongly supported
by evidence obtained from epidemiological studies of worker
populations, laboratory findings, and the clinical experience of
physicians and health care professionals.
Three recent authoritative and comprehensive reviews of the
scientific literature conclude that exposure to ergonomic hazards in
the workplace causes musculoskeletal disorders. These are a 1997 report
by the National Institute for Occupational Safety and Health,
``Musculoskeletal Disorders and Workplace Factors,'' and two
congressionally-mandated reports by the National Academy of Sciences,
``Work-Related Musculoskeletal Disorders,'' completed in 1999, and
``Musculoskeletal Disorders and the Workplace,'' completed in 2001.
In evaluating the extensive body of scientific literature,
comprising over 800 research studies and references, the January 2001
NAS report concluded that:
--``The panel's review of the research literature in epidemiology,
biomechanics, tissue mechanobiology, and workplace intervention
strategies has identified a rich and consistent pattern of
evidence that support a relationship between the workplace and
the occurrence of MSDs of the lower back and upper
extremities.''
--``The basic biology and biomechanics literatures provide evidence
of plausible mechanisms for the association between
musculoskeletal disorders and workplace physical exposures.''
The research literature has identified the biomechanical risk
factors in the workplace that pose a hazard to workers of developing a
musculoskeletal disorder affecting the lower back and upper
extremities. Workplace biomechanical risk factors that can cause MSDs
include force, repetition, vibration, awkward postures, and heavy
lifting. As the 2001 NAS report summarized:
--``The panel concludes that there is a clear relationship between
back disorders and physical load; that is, material handling,
load movement, frequent bending and twisting, heavy physical
work, and whole-body vibration. For disorders of the upper
extremities, repetition, force and vibration are particularly
important work-related factors.''
--``Low back disorder risk has been established through
epidemiological studies of work that involves heavy lifting,
frequent bending and twisting, and whole body vibration, as
well as other risk factors.''
--``The pattern of evidence for upper extremity disorders, as for the
low back, also supports an important role for physical factors,
particularly repetition, force and vibration.''
As noted above, the 1998 and 2001 National Academy of Sciences
studies on work-related musculoskeletal disorders were the result of
Congressional requests for a review of the scientific evidence on work-
related musculoskeletal disorders. Both of these reviews concluded that
there is a strong body of evidence that musculoskeletal disorders are
associated with exposure to workplace ergonomic risk factors and that
there are effective interventions to reduce the risk of these
disorders. The Congress and the Bush Administration should endorse
these findings and support the issuance of a new ergonomics standard to
protect workers.
an osha ergonomics standard is needed to protect workers from
musculoskeletal disorders
The key finding motivating Congress to enact the Occupational
Safety and Health Act in 1970 was the fact that ``personal injuries and
illnesses arising out of work situations impose a substantial burden
upon, and are a hindrance to, interstate commerce in terms of lost
production, wage loss, medical expenses, and disability compensation
payments,'' 29 U.S.C. Sec. 651(a). The purpose of the Act was to assure
so far as possible every working man and woman in the nation safe and
healthful working conditions and to preserve the country's human
resources.
As the major source of job injury and illness in the nation today
costing more than $45-$50 billion a year, work-related musculoskeletal
disorders are precisely the type of problem that the Act was intended
to address. Just as the Congress acted in 1970 and passed the
Occupational Safety and Health Act to address the high toll and cost of
workplace injuries and illnesses, it is imperative that OSHA promulgate
an ergonomics standard to address the toll and cost of musculoskeletal
disorders.
The severity of the problem of MSDs and the need for government
action was recognized more than 10 years ago by Secretary of Labor
Elizabeth Dole when she committed to taking the most effective steps
necessary to address the problem of ergonomic hazards. The need for
such action was reaffirmed in 1992 by Secretary of Labor Lynn Martin
when she initiated rulemaking on an OSHA ergonomics standard in
response to a petition from the United Food and Commercial Workers,
AFL-CIO and many unions.
Unfortunately ideological opposition to government action by
industry groups and some in Congress has delayed and blocked these
needed protections. More than 10 years after government action was
promised, workers still lack legal protection against ergonomic
hazards.
In the aftermath of the recent action by Congress and the Bush
Administration to repeal OSHA's November 2000 ergonomics standard,
Secretary of Labor Elaine Chao committed the Department of Labor to
developing a comprehensive approach to address musculoskeletal
disorders. The AFL-CIO supports and has long advocated a comprehensive
approach to addressing MSDs. But any approach to addressing MSDs must
have as its core and foundation a mandatory protective OSHA standard.
Voluntary compliance assistance, outreach, education and further
research can and should complement and supplement regulatory action.
But voluntary approaches alone are insufficient to provide workers the
protection they need and deserve.
Indeed, the major advances in protecting workers from MSDs and
implementation of workplace ergonomic programs have come as a result of
mandatory action required by OSHA enforcement under the general duty
clause. Ergonomic programs in auto manufacturing, meatpacking, poultry,
and garment industries all have their roots in the settlement
agreements that stemmed from OSHA enforcement actions. It is necessary
and appropriate to extend these same protections by regulation to all
sectors and workplaces where workers face a significant risk of
musculoskeletal disorders.
The AFL-CIO has long advocated that an OSHA ergonomics standard be
based on the good employer practices that have been demonstrated to be
effective at reducing the incidence and severity of work-related MSDs.
As the National Academy of Sciences (NRC/IOM, 2001) and General
Accounting Office (GAO, 1997) have both reported, these effective
practices implement ergonomic principles and follow a programmatic
approach which includes employer commitment and employee participation,
job analyses and control, training and medical management.
These basic elements form the foundation of OSHA's 1990 Meatpacking
Guidelines and settlement agreements that have been implemented
successfully in key industries. These basic elements also form the
basis of many employer ergonomic programs that have been effective at
reducing MSDs. They also form the basis of the voluntary standard on
MSDs which is being developed by the Z 365 ANSI standard setting
committee. These basic elements were also the backbone of the November
2000 ergonomics standard issued by OSHA.
To be effective at preventing injuries and consistent with the
OSHAct, the AFL-CIO believes that an OSHA ergonomics standard should
also do the following:
--Cover all sectors and all workers at significant risk of injury.
OSHA's November 2000 ergonomic standard was limited to general
industry and excluded construction, maritime, agriculture and
railroads. MSDs are a major source of injury and illness for
workers in all sectors. State ergonomic standards in California
and Washington apply to all employers and workers. Any Federal
OSHA ergonomics standard should cover workers in all sectors as
well.
--Be pro-active and preventive. OSHA's November 2000 standard was
triggered only in response to worker reports of MSD injuries or
persistent symptoms, when workers also had significant exposure
to identified ergonomic risk factors. In the absence of any
injury, no action was required, even if the employer had
knowledge that serious hazards were present. All other OSHA
standards are triggered by worker exposure to hazards, not
reports of injuries. To be preventive an ergonomics standard
should respond to hazardous exposure, whether or not an injury
has occurred.
--Provide for early detection of MSDs and early intervention. MSDs
are cumulative progressive injuries that become more serious,
disabling and costly with continued exposure. One of the keys
to a successful ergonomics program is the early detection of
these injuries, so interventions can be made before damage is
serious and permanent. Early detection and intervention is also
key to reducing the cost of these injuries.
--Encourage reporting of MSDs and hazards and participation by
workers and their representatives. The early detection of MSDs
is only possible if workers feel free to report MSDs and MSD
hazards. Any standard must prohibit discrimination and
retaliation against workers who make such reports and prohibit
practices or policies that discourage worker reports. Such
provisions were appropriately included in OSHA's ergonomics
standard. To encourage early reporting and participation in any
medical management program, employees should not have to face
loss of wages for making these reports. This was the purpose of
the work restriction protection provision of OSHA's ergonomics
rule. The standard mandated that an employer follow a health
care provider's medical determination for job restriction of
injured workers. It also provided that on a temporary basis
when such restrictions were required, workers should not have
to lose wages or benefits.
This work restriction protection was not a workers' compensation
system. It's purpose was to encourage early reporting, not
after the fact compensation. It, in no way changed or altered
workers' compensation laws or benefits. Similar provisions have
been included in OSHA standards since 1978 when medical removal
protection was included in OSHA's lead standard. Such
provisions have been upheld by reviewing courts as permissible
and appropriate protective measures under the OSHAct. Such a
provision should be included in an OSHA's ergonomics standard.
--Provide for the reduction of exposure to ergonomic hazards to the
extent feasible. The reduction of exposure to ergonomic risk
factors--force, repetition, awkward posture, and vibration--
must be the heart of any ergonomics standard, just as it is the
heart of all OSHA standards. An ergonomics standard must
require employers to reduce exposures to ergonomic risk factors
so they no longer pose a hazard, or if that is not possible,
reduce them to the extent feasible.
As stated earlier, some employers have already taken action and
implemented measures similar to those outlined above to protect
workers. Many countries around the globe have implemented ergonomic
standards or manual handling standards. These include British Columbia,
Canada, Australia, Sweden and the member states of the European
Community which have adopted regulations to implement the European
Community directive on manual handling (Council Directive 90/269/EEC,
May 29, 1990) and directive on video display terminal use (Council
Directive 90/270/EEC, May 29, 1990).
The only reason why a mandatory ergonomics standard is not in place
in the United States today is because of the fierce ideological
opposition by some business groups, including the U.S. Chamber of
Commerce and the National Association of Manufacturers, and others to
any government intervention on this issue.
For 10 years these business groups have opposed any and every
attempt to regulate ergonomics at the state and Federal level. They
opposed state standards in California, North Carolina and Washington.
They opposed efforts by states and Federal OSHA to enforce against
ergonomic hazards under the general duty clause. They are now
challenging longstanding OSHA regulations that require musculoskeletal
disorders to be recorded on the OSHA log. They are even trying to block
a voluntary ANSI standard on MSDs that is now close to being finalized.
The misrepresentation by these groups of the facts and the science
and their fierce opposition to any ergonomic protections is directly
responsible for the serious and preventable injury to millions of
workers in this country. Unfortunately this past March, a majority in
the Congress and President Bush decided to side with these opponents of
protections and acted to repeal OSHA's ergonomics standard.
We believe that it is time that Congress, elected to be the
people's representatives, and the Bush Administration started doing the
people's business. The Department of Labor should act immediately to
issue--and the Congress should support--a new ergonomics standard to
protect the working men and women of this country.
Appendix B--MSD Data Comparison From Three States
WORK-RELATED CARPAL TUNNEL SYNDROME IN MASSACHUSETTS
[Massachusetts SENSOR Program vs. Massachusetts BLS, 1993-1996]
----------------------------------------------------------------------------------------------------------------
Massachusetts SENSOR
---------------------------------------- CTS cases
Additional Total reported by
Year All workers physician unique Massachusetts
compensation reported SENSOR BLS
cases only cases cases
----------------------------------------------------------------------------------------------------------------
1993..................................................... 1,076 281 1,357 379
1994..................................................... 1,156 185 1,341 627
1995..................................................... 885 86 971 321
1996..................................................... 915 104 1,019 431
----------------------------------------------------------------------------------------------------------------
Source: The Commonwealth of Massachusetts, Executive Office of Health and Human Services, Department of Public
Health, January 20, 1999.
MUSCULOSKELETAL DISORDERS IN OREGON
[Number of Injuries by Event that Caused the Injury, 1992-1994]
----------------------------------------------------------------------------------------------------------------
1992 1993 1994
-----------------------------------------------------
WC \1\ BLS \2\ WC BLS WC BLS
----------------------------------------------------------------------------------------------------------------
Repetitive Motion......................................... 545 950 1,038 857 1,521 1,156
Overexertion.............................................. 12,325 7,966 11,786 7,752 11,697 7,315
-----------------------------------------------------
Total............................................... 12,870 8,916 12,824 8,609 13,218 8,471
----------------------------------------------------------------------------------------------------------------
\1\ There are time-loss-claims with 4 or more days away from work. Private insurers accounted for 49 percent of
the claims, the SAIF Corporation for 31 percent, and self-insured companies for 20 percent.
\2\ Number of private industry nonfatal occupational injuries and illnesses involving three or more days away
from work. Days-away-from-work cases include those which result in days away from work with or without
restricted work activity.
Source: BLS State data for 1992, 1993, 1994 and ``Oregon Workers' Compensation Characteristics Calendar Year
1995,'' Research & Analysis Section, Oregon Department of Consumer & Business Services, June 1997.
MUSCULOSKELETAL DISORDERS RESULTING FROM OVEREXERTION IN WASHINGTON STATE
[Industrial Insurance Claims vs. BLS Data, 1992-1994]
--------------------------------------------------------------------------------------------------------------------------------------------------------
BLS data \1\ Industrial insurance claims \2\
---------------------------------------------------------------------------------------
Year 1 or more days 3 or more days Total # MSD \3\ Total # time-loss MSD
away--overexertion away--overexertion claims--overexertion Claims \4\--overexertion
--------------------------------------------------------------------------------------------------------------------------------------------------------
1992............................................................ 17,107 13,258 48,019 21,575
1993............................................................ 16,488 12,514 46,970 20,578
1994............................................................ 14,345 11,046 45,747 19,768
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Reflects both State fund and Self Insured employers.
\2\ The term claims refers to accepted claims only. Data reflects both State fund and Self Insured employers.
\3\ MSDs can include strains/sprains, joint inflammation, lower back pain and nerve compression syndromes. 93 percent of all MSD claims were coded
overexertion.
\4\ Washington State defines time loss claims as those claims with 4 or more days away from work and includes claims where the employee is kept on
salary, has loss of earning power or provisional time loss.
Source: ``Work-Related Musculoskeletal Disorders: Washington State Summary 1992-1994,'' State of Washington Dept. of Labor and Industries, Oct. 1996 and
data from the State of Washington Dept. of Labor and Industries, Jan/Feb 1999.
Senator Specter. Thank you very much. Dr. Bradley Evanoff
of Washington University School of Medicine.
STATEMENT OF DR. BRADLEY EVANOFF, ASSISTANT PROFESSOR
OF MEDICINE, WASHINGTON UNIVERSITY SCHOOL
OF MEDICINE
Dr. Evanoff. Mr. Chairman, Senator Landrieu, as a general
internist and occupational health physician, I diagnose and
treat patients with both work-related and nonwork-related
illnesses and carry out research on musculoskeletal disorders.
Thank you for the opportunity to address the committee today. I
will attempt to answer the specific questions which are posed
to our panel.
What types of injuries occur? The term musculoskeletal
disease is not a single diagnosis but represents a group of
well-recognized injuries and diseases which affect the bones,
joints, muscles, tendons, and nerves. Examples of these
conditions include hand/wrist tendonitis, epicondylitis, low
back pain, and carpal tunnel syndrome.
Specific objective criteria exists for the diagnosis of
these musculoskeletal disorders. For example, the American
College of Occupational and Environmental Medicine has issued
practice guidelines containing specific diagnostic criteria
from more than 50 distinct musculoskeletal disorders which may
be related to work.
These diagnoses are based on patients' symptoms and on
physical examination findings by a treating clinician, and when
appropriate, laboratory and radiographic tests. Musculoskeletal
disorders are routinely diagnosed by physicians all over the
world.
Who suffers these injuries? Musculoskeletal disorders are
seen in a variety of patients and have a variety of causes.
Factors such as age, gender, and coexisting diseases all
influence the probability that a person will suffer from an
MSD. However, workplace exposures are among the most important
determinants of musculoskeletal disorders in many working
populations.
Physicians who evaluate working people with a
musculoskeletal disorder routinely evaluate whether their
patient's condition is work-related or not by considering both
work- and nonwork-related factors. In evaluating work
relatedness, physicians can rely on a large body of literature
showing that certain musculoskeletal disorders are seen much
more frequently in workers whose jobs involved repeated
forceful use of the hands and arms, repeated heavy lifting or
bending of the back, or exposure to vibration.
When taken as a whole, the medical literature shows that
increased exposure to these physical factors is associated with
a greater risk of an injury.
Worker groups at increased risk include nurses and nurses'
aids, garment workers, construction workers, meat packers and
other food processing workers, and workers in manufacturing and
agriculture.
How many suffer MSDs and what is their severity?
Musculoskeletal disorders are clearly the most common group of
occupational diseases and injuries and account for the majority
of lost time, lost productivity and workers' compensation
costs.
Data from the Bureau of Labor Statistics indicate that
there are almost 600,000 lost workday cases due to repetitive
trauma and overexertion annually. The National Academy of
Sciences estimates that almost 1 million lost workday cases
occur annually.
It is important to know that these figures are
underestimates. They do not include cases for which no lost
workdays occurred. And a number of studies show that employers
and workers routinely under report the occurrence of these
disorders.
Musculoskeletal disorders represent an enormous burden to
our country in terms of lost productivity and personal
suffering. Conservative estimates of national costs for
musculoskeletal disorders are around $50 billion annually.
The National Academy of Sciences estimated that the cost
may exceed 1 percent of our gross domestic product.
The personal cost to workers are much harder to quantify.
Many of my patients are unable to perform not only work duties
but simple daily activities such as carrying groceries, opening
a jar or lifting a child. While many patients recover quickly
from these disorders, others have prolonged disabilities.
prepared statement
In summary, musculoskeletal disorders are commonly accepted
conditions which can be confidently diagnosed. The personal and
economic costs of this disorders are high, and workplace
physical exposures are a prominent and preventable risk factor.
In my opinion, an adequate scientific basis exists to
support a standard. Thank you.
[The statement follows:]
Prepared Statement of Dr. Bradley Evanoff
My qualifications to testify: I am a physician and researcher with
over ten years of experience in treating and studying occupational
musculoskeletal disorders (MSDs). I am currently an Assistant Professor
of Medicine at Washington University School of Medicine, where I am
Chief of the Division of General Medical Sciences and the Richard and
Elizabeth Henby Sutter Chair of Occupational, Industrial, and
Environmental Medicine. As a medical researcher, I have published more
than two dozen peer-reviewed journal articles, dealing primarily with
the diagnosis and treatment of musculoskeletal disorders and the
prevention of work-related injuries. I have also presented findings of
my research at numerous scientific meetings, and have served as the
chairperson of sessions at scientific meetings devoted to the
prevention of occupational musculoskeletal disorders. I serve as a
reviewer for several medical and public health journals. I have been
involved in the national debate concerning ergonomics and work-related
musculoskeletal disorders through my participation as an invited
speaker at the 1998 National Academy of Sciences meeting on ``Work-
Related Musculoskeletal Disorders: A Review of the Evidence.'' I have
also served as a member of the American National Standards Institute,
Accredited Standards Committee on Control of Cumulative Trauma
Disorders.
My interests in musculoskeletal disorders were shaped by my
clinical experiences in treating injured workers. I was originally
interested in occupational cancer research, but as I spent more time in
the field of occupational health, I realized that musculoskeletal
disorders were by far the largest preventable cause of morbidity and
disability among the working populations which I treated. As a treating
physician, I diagnose and treat patients every week who have work-
related musculoskeletal problems such as back pain, tendonitis, and
carpal tunnel syndrome. Over the course of my career, I have treated
several thousand workers with musculoskeletal disorders related to
their work. Many of these disorders could have been prevented or
subsequent disability reduced through better job design and more timely
medical treatment which took work factors into account.
I feel that I am fortunate to be involved in many aspects of work-
related musculoskeletal problems--I treat individual workers, I advise
employers on programs to prevent musculoskeletal problems, and I engage
in research on the causes of these disorders and the effectiveness of
interventions aimed at reducing their number and severity. There is no
question that a great deal of suffering, job displacement, and economic
loss is due to musculoskeletal disorders. It is also clear that many of
these disorders are preventable, and that appropriate action can reduce
this disease burden.
I have based my opinions on my professional background and
training, which includes clinical experience treating patients with
MSDs, research experience in performing and analyzing studies of work-
related MSDs, and work on intervention programs to reduce MSDs in
working populations. Based on the existing scientific evidence and my
own professional experiences, I conclude that there is strong evidence
that certain work exposures are causally related to carpal tunnel
syndrome, tendonitis, back pain, and other MSDs among workers. This
conclusion takes into account the strengths and limitations of existing
studies, including issues of confounding, bias, and research design.
The existing research base is also consistent with my clinical
experience, where I have seen thousands of workers with clinically
diagnosed musculoskeletal disorders associated with the same physical
risk factors described in the scientific literature. Existing research
and my own clinical and administrative experiences have demonstrated
that ergonomic interventions can prevent injuries in a cost-efficient
manner, and that improved medical treatment programs can prevent
disability from work-related MSDs.
adequate scientific and clinical basis exists to support an ergonomics
standard
The workforce of our nation incurs a large number of
musculoskeletal illnesses and injuries which are caused by or related
to workplace exposures. Many of these disorders are preventable. Both
my academic and my clinical experiences indicate that MSDs can be
reliably diagnosed using accepted clinical guidelines, that a
substantial proportion of MSDs are related to exposure to workplace
physical factors, and that a significant part of this burden is
preventable.
Acute and chronic work-related musculoskeletal disorders (MSDs)
affect an estimated 19 million persons per year in the United States
and account for the majority of workers' compensation costs nationwide
(Bernard 1997, Webster and Snook 1994). Over the past two decades,
there has been considerable evidence presented in the scientific and
medical literature which supports a causal relationship between work
activities and musculoskeletal disorders, including back pain, carpal
tunnel syndrome, and tendonitis. The available literature when taken as
a whole strongly supports the presence of a causal association between
exposure to certain workplace physical activities and the development
of specific MSDs. The actions of health and safety professionals all
over the country reflect the knowledge that workplace exposures should
be reduced in order to reduce injuries and disability.
The evidence for a causal association between work exposures and
musculoskeletal disorders has been well summarized by researchers at
the National Institute for Occupational Safety and Health (Bernard
1997) as well as by international scientific panels and by regulatory
agencies in other countries. (Kourinka and Forcier 1995) The National
Academy of Sciences convened a multidisciplinary international expert
panel in 1998 to review available evidence on work-related
musculoskeletal disorders. I was one of the invited participants in
this process. After thorough review of available scientific evidence,
including conflicting points of view, the National Academy of Sciences
concluded that musculoskeletal disorders were a major source of
disability and economic loss, that workplace physical exposures were an
important cause of these disorders, and that interventions to reduce
workplace physical exposures could reduce the number of musculoskeletal
disorders. Multiple expert panels and individual scientists reviewing
the scientific evidence have arrived at these same conclusions, as has
a second review completed by the National Academy of Sciences, released
earlier this year.
The conclusions of this second panel report by the National Academy
of Sciences unambiguously support important arguments in favor of an
ergonomics standard. The panel found strong and consistent evidence
from both epidemiologic studies and biomechanical studies to support a
relationship between workplace physical exposures and the occurrence of
MSDs of the low back and upper extremities. The panel found that
existing research demonstrated the effectiveness of appropriate
ergonomic interventions in reducing the risk of low back pain and upper
extremity symptoms. The panel found that work-related musculoskeletal
disorders are a major source of costs and morbidity, and that some of
this burden to society and to individuals is preventable.
A number of non-governmental groups have taken actions based on the
evidence available. After concluding that sufficient evidence existed
to promote a standard intended to protect worker health and safety, the
American Conference of Governmental Industrial Hygienists (ACGIH)
recently announced exposure limits for physical exposures in order to
reduce musculoskeletal disorders. The ACGIH is a respected and
authoritative non-governmental body which publishes exposure limits for
chemical and physical hazards which are widely used in industry. The
American College of Occupational and Environmental Medicine has
published practice guidelines which clearly link workplace physical
exposures to musculoskeletal disorders. The American National Standards
Institute has a committee charged with creating a national industrial
standard to reduce work-related musculoskeletal disorders. These and
other groups have acted because of the scientific evidence showing that
MSDs are a serious problem, that workplace exposures are related to
many MSDs, and that the risk of harm to employees can be diminished by
reduction in physical exposures.
My own reviews of the scientific literature (Evanoff 1999, Evanoff
and Rempel 1998) have found that musculoskeletal disorders have been
studied in a variety of work settings. Numerous studies have shown that
higher rates of these disorders are seen among workers whose jobs
demand repetitive or forceful movements, or who are subject to
vibration or prolonged awkward postures. Systematic review of the
medical and scientific literature shows that there is evidence of a
causal relationship between work factors and carpal tunnel syndrome,
tendonitis of the hand and wrist, epicondylitis, neck disorders,
shoulder disorders, and low back disorders.
Opponents of an ergonomics standard have attacked the scientific
basis of the standard by suggesting that MSDs do not represent
``objectively'' diagnosed entities, and consist only of worker-reported
aches and pains. On the contrary, most MSDs fall into well recognized
and commonly accepted diagnostic classifications which utilize both
symptoms and specific signs detected on physical examination by a
health care provider. It must be recognized that ``MSD'' is not a
diagnosis itself, but a term used to group many different diagnoses
affecting different body parts. For example, the practice guidelines
promulgated by the American College of Occupational and Environmental
Medicine list ``Diagnostic Criteria'' for more than fifty separate
musculoskeletal disorders. These conditions include such diagnoses as
lateral and medial epicondylitis, ulnar and radial nerve entrapment,
shoulder impingement, rotator cuff tear, wrist tendonitis/
tenosynovitis, DeQuervain's tenosynovitis, trigger finger, and carpal
tunnel syndrome. These diagnostic criteria include mechanism of injury,
patient symptoms, physical examination maneuvers, and for some
disorders, diagnostic test results. The described mechanisms of injury
for over two dozen listed disorders include repetitive use, chronic
overuse, or repeated trauma.
Good quality epidemiologic studies have used definitions of MSDs
which require combinations of symptoms and physical examination
findings which are similar or identical to the information used to
diagnose patients in clinical practice. Many of the MSD definitions
used in the epidemiologic studies are the same definitions of MSDs
described in medical textbooks and in practice guidelines. The work
exposures described in the scientific literature are reflected in the
work exposures reported by my patients with musculoskeletal disorders,
and by the work exposures which I have observed on visits to workplaces
with high rates of musculoskeletal disorders. These same work exposures
are the ones cited by the American College of Occupational and
Environmental Medicine in their practice guidelines and by the ACGIH in
their threshold limit values for physical exposures.
the importance of early recognition and appropriate treatment of msds
The proposed OSHA ergonomics standard required early access to
appropriate medical treatment, evaluation of workers' jobs when there
has been a MSD, and the provision of limited or modified work duties
when necessary, including when recommended by a health care provider.
Each of these individual provisions is supported by current research
and clinical practice. In addition, there is good evidence that
comprehensive programs which integrate ergonomic changes and medical
treatment are effective in reducing the incidence and severity of work-
related musculoskeletal disorders.
Early recognition and treatment of musculoskeletal disorders is
essential because it allows earlier treatment of affected workers, at a
time when treatment can prevent progression to a more severe condition.
Workers who are treated in the early stages of a disorder have a better
prognosis, and are less likely to have prolonged disability, than
workers who receive appropriate medical attention only after prolonged
duration of symptoms. The medical literature consistently supports the
observation that conservative management is most effective when begun
in the early stages of these disorders, and that patients who are
treated only after a prolonged symptomatic period are less likely to
respond favorably than those treated earlier (Gelberman et al., 1980;
Dellon, 1989; Stern, 1990; Rystrom & Eversman, 1991). With some
disorders, such as carpal tunnel syndrome, patients can often be
treated conservatively in the early stages of disease, while surgery is
often necessary when patients present with advanced disease. Early
detection is necessary to ensure that signs and symptoms of work-
related MSDs are recognized and treated appropriately through medical
management, administrative controls, and job evaluation.
Both healthy and injured workers can potentially benefit from
evaluation of their workplace for identification of physical stressors
that can be eliminated. Simple modifications can often be made to a
workplace which enable the work to be done with less effort on the part
of the worker. Such modifications, where possible, can prevent injury
and can enable injured workers to safely return to their usual jobs
more quickly. Clinical experience demonstrates that ergonomic
evaluation and intervention is effective in the treatment of workers
being treated for a work-related MSD, since earlier safe return to work
is facilitated when clinicians have more information about a patient's
job demands and exposures, and when worksite modifications reduce
physical exposures. A number of authors have advocated the importance
of ergonomic changes in treating workers with work-related
musculoskeletal disorders (Melhorn 1996, Higgs and Mackinnon 1995,
Norris 1993, Feuerstein et. al. 1993, Halpern 1992, Travers 1992,
Herbert 2000).
Comprehensive ergonomic programs which incorporate primary
prevention of MSDs through ergonomic changes in jobs, early detection
of MSDs through surveillance, and early treatment of MSDs with an
emphasis on early return to modified work have been endorsed by many
corporations and by medical professionals. The American College of
Occupational and Environmental Medicine, the world's largest group of
Occupational Health physicians, has recently released ``Occupational
Medicine Practice Guidelines'' which describe what the College
recommends as best medical practice in the diagnosis and treatment of
work-related disorders. These practice guidelines explicitly recommend
many of the elements which are contained in OSHA's proposed regulation
as representing best medical practice. These include endorsement of the
application of ergonomic principles to job design in order to prevent
MSDs, and the use of workstation or tool adjustment to avoid further
aggravation of a disorder once it has begun. Return of workers to
modified work which has reduced physical exposures is strongly
recommended as part of treatment--the guidelines note that the best
success with return to work is seen when workers go back to their
original job with modifications to reduce physical exposures. The
guidelines list ``substantive associations'' between physical risk
factors and a variety of MSDs including shoulder tendonitis, hand/wrist
tendonitis, carpal tunnel syndrome, neck muscle tension, and low back
pain. Specific job modifications are recommended for these and other
disorders. The guidelines also note that delayed presentation (not
receiving early recognition and treatment) is a risk factor for delayed
functional recovery in patients with a MSD.
My own experiences from over ten years of treating injured workers
have shown me the importance of early treatment and the importance of
modifying job duties to facilitate return to work. The proposed
ergonomics standard addressed these important aspects of disability
prevention. While the main focus of prevention efforts should be on
primary prevention--the reduction or elimination of workplace risk
factors--it is also important to ensure that workers have access to
appropriate and timely medical care if they do become injured. The
goals of a medical management program should be to reduce or eliminate
symptoms, prevent progression of MSDs, reduce the duration and severity
of functional impairment, and prevent or reduce the severity of
disability. Important elements to such a program include surveillance,
timely access to appropriate health care providers, job evaluation of
injured workers, and the availability of appropriate job modification.
Follow-up of treated workers and coordination with primary prevention
efforts are also important.
My clinical experience clearly indicates that effective treatment
of work-related musculoskeletal disorders frequently requires a
reduction in workplace physical exposures for the affected employee.
The vast majority of injured employees are able to return to productive
work very quickly, as long as their work is modified to reduce physical
exposures to the affected body part. Job modifications which reduce
physical exposures are frequently inexpensive and simple, and can help
an employee safely return to work sooner, as well as preventing risk of
future injury. Examples of job modifications include training or
retraining, simple job changes to prevent awkward postures (such as a
step stool or tilted work surface), changes in tool design or
maintenance, or changes in procedures (such as job rotation). Where
there is no simple fix for a physical exposure which is causing or
exacerbating a musculoskeletal condition, temporary job transfer or
restrictions are important to allow the patient's injury to heal.
Examples of temporary restrictions include reduction in pace or
quantity of work, restriction of certain tasks, or limitation of hours
worked. If an employee is to be transferred to a different job, the new
job should be assessed by the employer and the healthcare provider to
be sure that the employee will not be exposed to relevant physical risk
factors When this cannot be accomplished, temporary removal from work
will allow time for healing. In most cases, I feel that keeping an
injured employee at work in an appropriate modified position is
preferable to time loss. What OSHA is requiring in the standard is
common medical practice among occupational health professionals.
In my experiences of treating patients and advising the
administration of employee health programs, I have found that choice of
a healthcare provider for injured workers is important. Ideally,
healthcare providers should have training or experience in ergonomics
and the role of work modifications in the treatment of work-related
musculoskeletal disorders. Effective diagnosis and treatment requires
knowledge of specific job duties. The best way for a healthcare
provider to get knowledge of job duties is through a worksite visit.
Since this is impractical in some clinical settings, information about
exposures and job duties can also be obtained through a written work
description, or a videotape of the job task. Employers should have a
contact person with knowledge of job activities and the ability to
coordinate appropriate job placement during a recovery period. Working
knowledge of the industry and the specific workplace is also needed in
order to make appropriate recommendations regarding temporary or
permanent job modifications. In my experience, some employers readily
provide detailed information about job duties and physical exposures to
the treating physician. It is more difficult to provide optimal care
for injured workers when this information is not available.
The medical literature has examples of successful programs which
have decreased the length or severity of disability resulting from
injuries through integrating ergonomic interventions as part of medical
treatment of injured workers. One such study evaluated work-related
back pain among workers from a variety of industries who had been away
from work for more than four weeks due to their back injuries. (Loisel
et. al. 1997). Workers were randomly assigned to receive an ergonomics
intervention, an intensive clinical and rehabilitation intervention,
neither, or both. The ergonomics intervention consisted of a worksite
ergonomics evaluation that included labor and employer representatives
in determining the need for job modification. After observation of a
worker's tasks in conjunction with a trained ergonomist, these parties
determined the need for modifications to improve the worksite.
Implementation of the recommended solutions remained the employer's
responsibility. The clinical and rehabilitation intervention consisted
of patient education (``back school''), referral to a back pain
specialist, and a multidisciplinary work rehabilitation intervention.
Combination of the rehabilitation intervention along with the
ergonomics intervention was the most successful in returning injured
workers to work. The ergonomics intervention was the most successful
element of this program, resulting in more than a two-fold increase in
the rate of return to usual work. By facilitating return to usual work,
the ergonomics intervention appeared to reduce progression to long term
disability. In this study, the intensive clinical and rehabilitation
intervention did not significantly reduce the time of absence from
regular work when applied separately from the ergonomics intervention.
Another example of an integrated program was reported among sheet
metal workers at an aircraft manufacturer. This program combined pre-
placement evaluations of workers with ongoing surveillance for symptoms
and signs of upper extremity musculoskeletal disorders in order to
ensure early medical evaluation of affected workers. Job modification
was implemented for those with signs of early disorders, through
restriction of work hours and restriction of use of vibrating hand
tools. This program reported decreased workers' compensation costs,
decreased time loss, and decreased severity of injury following the
implementation of this program for screening, surveillance, early
medical evaluation, and job modification. (Melhorn JM 1999)
Other authors have described comprehensive initiatives to manage
the incidence and cost of occupational injuries that included an
ergonomics component directed specifically toward injured workers. One
such program has been described among hospital employees at an academic
health center (McGrail et. al. 1995). This study showed decreases in
musculoskeletal injuries, time loss (change from 10.4 days to 6.6 days
average time loss), and total case costs (18 percent reduction)
following the implementation of a comprehensive intervention that
included case management, treatment by physicians experienced with work
injuries, and the use of ergonomic worksite evaluation and
modification. A later report from this group described elements of the
program aimed at the early diagnosis and treatment of work-related
upper extremity MSDs. The program included ergonomic assessment and
abatement of the affected employees' work areas, and close coordination
between the treating physicians and the ergonomists. The program
resulted in pronounced decrease in the number of work-related upper
extremity MSDs and a virtual elimination of cases which required
surgery. The authors concluded that a coordinated program of medical
care, ergonomic assessment, and intervention can be effective in the
prevention of MSDs. (Bernacki 1999)
These and other peer-reviewed studies clearly indicate that a
multi-element program can reduce the cost and burden of MSDs in
different working populations. There are also numerous industry case
reports where the introduction of ergonomic or medical management
interventions have reduced costs and injury rates. Most major
corporations have ergonomics programs, in recognition that such
programs are effective in reducing injuries. Successful approaches have
most often used a combination of ergonomic principles for prevention,
as well as improved recognition and management of those disorders which
have occurred.
I have also studied the effects of ergonomic assessments and
interventions as part of the care of workers with WRMSD. As the result
of a ``natural experiment,'' we have collected pilot data on cost
outcomes of ergonomic intervention in active workers' compensation
patients employed by a local educational institution. Prior to
September of 1996, ergonomic evaluations requested by the treating
physician were not covered by the workers' compensation insurance
carrier and requests for this service were denied. This policy changed,
and ergonomics evaluation and intervention was then allowed under
workers' compensation when ordered by the treating physician. These
cases were predominantly neck and upper extremity disorders among
office employees; the ergonomic interventions consisted of changes in
workstation layout. We compared 11 consecutive cases referred by the
treating physician to the ergonomist prior to the administrative change
with 20 consecutive cases after coverage was allowed. These cases were
all ones in which the treating physician thought that work factors were
important in causing disease or retarding healing. Comparison of total
workers' compensation costs for these cases showed a median cost of
$5,130 among the patients referred for ergonomic evaluation who did not
receive it, compared to a median of $4,082 among patients who did
receive the physician recommended ergonomic evaluation. Costs included
medical treatment, time loss, and permanent disability payments. Cost
in the intervention group included the cost of the ergonomic evaluation
and intervention, which averaged $280. Although these data do not come
from a randomized study, they represent a series of cases from the same
workplace referred by the same group of treating physicians, differing
only in the fact that the ergonomic intervention was denied to the
first group and given to the second. Based in part on this study, we
are currently conducting a randomized trial funded by NIOSH to assess
the effectiveness of an integrated ergonomics and case management
intervention on cost and disability outcomes among injured workers.
the effectiveness of ergonomic interventions
Review of the scientific literature demonstrates that workplace
ergonomic interventions can prevent injuries and reduce days lost due
to injuries. This evidence comes from a number of studies published in
the peer-reviewed literature which show the effectiveness of ergonomic
interventions at various worksites and employers. The 1998 report by
the National Research Council stated that ``The literature provides
evidence that interventions, of various types and complexity, can
prevent the development of musculoskeletal disorders in specific
industries and occupational groups.'' The NRC report concluded that
``Research clearly demonstrates that specific interventions can reduce
the reported rate of musculoskeletal disorders for workers who perform
high-risk tasks. No known single intervention is universally effective.
Successful interventions require attention to individual,
organizational, and job characteristics, tailoring the corrective
actions to those characteristics.'' Examples of published intervention
studies familiar to me are given below; the background information
provided by OSHA gives over 100 examples of successful ergonomic
interventions.
The effectiveness of ergonomic interventions in the prevention of
musculoskeletal disorders was shown by a study in a telecommunications
equipment manufacturing plant, where workstations were re-designed to
reduce postural stress on workers. Following this intervention, time
loss was reduced by over 40 percent and employee turn-over was reduced
by 75 percent. Cost-benefit analysis showed that the return on
investment for the ergonomic interventions was 9 to 1. (Aaras 1994).
Another study in telecommunications manufacturing sought to control the
incidence and severity of repetitive trauma disorders associated with
hand tool operations in a manufacturing facility with 6,600 employees.
Repetitive trauma disorders were the leading cause of lost time and
workers' compensation expenses at this plant. The incidence rate of
OSHA reportable repetitive trauma disorders was 2.2 cases per 100 full-
time equivalent workers (FTE) and resulted in 1,001 lost workdays in
1979. In the spring of 1981, the plant safety and health committee
undertook a control program that included creation of a task force, a
training program, improvements in the design of workstations and
tooling, and management of restricted workers. During 1982, the
incidence rate of repetitive motion disorders has decreased to 0.53
cases per 100 FTE and resulted in only 129 lost workdays. (McKenzie
1985)
A study at Gold Kist poultry (Jones 1997) reported results of an
intervention undertaken due to high rates of upper extremity MSDs--47.7
per 1,000 workers in 1990. This plant instituted a corporate ergonomics
program which utilized ergonomic committees at each facility. Key
program elements included training, worksite analysis and task design,
and the implementation of medical management procedures. This
combination of worksite task analysis and medical management is similar
to the program elements proposed by OSHA. This program resulted in a 46
percent decrease in upper extremity MSD rates over a five year period.
Another study evaluated a back injury prevention program undertaken
in municipal workers in California. The program consisted of a
combination of worker education, training in safer work practices,
physical fitness activities, and ergonomic interventions including
making safety equipment more available and improving the design of work
facilities (through such measures as safety flooring, improved
furniture, and rearranging storage space to minimize transport
distances). Comparison of an intervention group and a control group of
employees who did not receive the intervention showed a decline in back
pain prevalence and a reduction in injuries among the intervention
group. This study evaluated cost savings due to the intervention as
well as documenting the reduction in back pain and injuries. Cost-
benefit analysis showed a net savings of over $160,000 resulting from
decreased workers' compensation and medical claims, and reduction in
sick days. Return on investment was estimated at 179 percent. (Shi
1993)
One of my own studies (Evanoff 1999) examined work injuries and
other outcomes before and after the implementation of a participatory
ergonomics team among hospital orderlies, a group at high risk for
injuries of the back, shoulder, and knee. This team designed and
implemented changes in training and work practices, which included
standardization of lifting procedures, an apprenticeship program for
new workers, and use of mechanical lifting and transfer aids. The two
year post-intervention period was marked by a 50 percent decrease in
OSHA recordable work injury, a 74 percent decrease in lost time injury,
and an 81 percent decrease in injuries with three or more days of time
loss. Total lost days declined from 136.2 to 23.0 annually per 100
full-time worker equivalents (FTE). Annual workers' compensation costs
declined from $237/FTE to $139/FTE. The proportion of workers with
musculoskeletal symptoms declined as well. Other researchers using
participatory ergonomics teams have demonstrated the abilities of such
teams to work effectively to address musculoskeletal hazards (Moore and
Garg 1996, Moore and Garg 1997).
I have directed a second study which has been presented as an
abstract but not yet published. This was an ergonomics intervention
among 117 workers employed in a hospital billing office, who were
offered an educational session and individual workstation evaluations,
with changes in workstation layout where appropriate. Changes included
adjustments in computer keyboard and monitor setup, adjustments in
seating, and changes in desk layout. Lost work days and total costs for
workers compensation decreased dramatically in the two years following
this intervention, compared to the two preceding years. Annual lost
work days declined from a rate of 51 days per 100 full-time equivalents
(FTE) to a rate of 25 days per 100 FTE. Annual workers' compensation
costs declined from a high of $578 per FTE to a low of $120 per FTE.
The total cost of the intervention was $255 per FTE; return on
investment over 18 months following the intervention was over 2 to 1.
Other studies (Kukkonen 1983, Ohara 1976, Parenmark 1988, Oxenburgh
1985, Lutz 1987) have also demonstrated reductions in symptoms, signs,
or lost time following the implementation of interventions to reduce
exposure risk factors for musculoskeletal disorders. Ergonomic job
design clearly offers great potential for preventing musculoskeletal
disorders of the low back and upper extremities. (Garg & Moore 1992).
My personal experience agrees with the literature cited above. I am
personally aware of many local worksites where ergonomic analysis and
job changes have led to improvements in symptoms or reductions in
injury rates among workers. I have seen dozens of case reports of
industries where the implementation of ergonomics programs have
resulted in reductions in injury rates or lost time. These industry
case reports offer important additional information to the peer-
reviewed scientific literature, given the daunting logistical and other
barriers to performing true ``experimental'' studies of workplace
ergonomic interventions. I have served as the medical director of an
ergonomics program aimed at reducing injuries among the 23,000
employees of a large health system. Musculoskeletal injuries and lost
days have declined since the implementation three years ago of a
system-wide ergonomics program. A NIOSH funded project within five
nursing homes in our health system has demonstrated a marked decline in
lifting injuries following an ergonomics intervention which consisted
of training and the purchase of mechanical patient hoists.
My personal experiences with research studies of ergonomic
interventions, as well as my experience with ergonomic programs in
industry, have convinced me that appropriately designed ergonomics
programs can reduce injuries and disability in many workplace settings.
summary
Based on my knowledge of the relevant scientific literature, my
observations of best practices among employers and physician groups,
and my own clinical and administrative experiences, I conclude that
there is ample evidence to support specific program elements proposed
by OSHA. Physical exposures in the workplace are clearly a significant
cause of musculoskeletal disorders. Reduction in physical exposures
through training, workplace design, or change in practices can reduce
disability due to musculoskeletal disorders. Appropriate medical
treatment early in the course of work-related musculoskeletal disorders
can lead to better functional outcomes and reduced disability. Though
future research findings will no doubt refine and better inform our
actions, we need not wait to begin action. Effective solutions are
available now, and a large burden of disability can be prevented by
using what we currently know.
Appendix--Refutation of Some Common Arguments Against an Ergonomics
Standard
Critics of the conclusion that work activities are causally related
to musculoskeletal disorders raise a number of arguments which are not
convincing on closer examination. Four common arguments are addressed
below.
Argument 1: Epidemiology or observational studies cannot
demonstrate causation; only randomized prospective studies can do
this.--While experimental studies where humans are randomly assigned to
receive or not receive some treatment provide the strongest evidence
for a health effect, it is obviously impossible to perform this type of
study for exposures we think may cause harm. There are well-established
ways to link observational data to a decision about causation of
illness which can be valid in the absence of experiemental data. For
example, the vast majority of the scientific community concluded that
tobacco smoking caused a number of health problems based on
observational studies which showed much higher rates of some diseases
among smokers. It was not necessary to do an experiment where people
were randomly assigned to smoke or not smoke. Data on the health
effects of most occupational exposures such as lead or asbestos also
rely on observational studies, which can demonstrate causality in a
scientifically acceptable fashion.
Argument 2: Work can't be the cause of MSDs since some workers get
these disorders and other workers doing the same job don't have any
problems.--This argument is specious. People vary in their
susceptibility and resistance to disease and injury, and people with
identical exposures frequently have different health effects. Exposures
clearly interact with personal factors to produce disease in some but
not others--this does not change the importance of the exposure in
causing the disease. A minority of heavy smokers die from lung cancer,
yet we readily accept that smoking causes lung cancer because heavy
smokers are much more likely to get this disease than non-smokers.
Though genetic makeup and other personal factors are clearly important
in determining which smokers die from lung cancer, in the absence of
smoking the vast majority of these cancers would never have occurred.
Argument 3: Work can't be a major cause of MSD since there are so
many other conditions which contribute to MSD risk.--As with most
diseases, MSDs are multifactorial in origin. It is nonetheless possible
to study the effects of risk factors in isolation. Consider, for
example, heart disease. There are many risk factors for heart disease
which cannot be changed, including age, gender, and genetic makeup.
There are other risk factors that can be changed, such as high blood
pressure, blood lipids, exercise, and smoking. Most individuals have
more than one risk factor, yet we can study the amount of heart disease
that is caused by smoking, or hypertension, or lack of exercise. We can
also direct interventions at reducing heart disease risk by targeting
one or more of these risk factors. Changes (positive or negative) in
one risk factor can significantly alter the risk of disease, even if
other risks do not change. Similarly, in MSDs, personal risk factors
such as obesity, age, gender, and other medical conditions account for
some fraction of the total disease burden. In many workers, however,
workplace exposures are the primary determinant or cause of the
disorder. Comparisons of working populations which do not differ
substantially in non-work risk factors have shown substantial
differences in MSD rates linked to workplace exposures. The
intervention studies cited above show that prevention efforts targeted
at workplace physical exposures can reduce the risk of MSDs.
Argument 4: Research shows only that work may cause some symptoms
of discomfort, but does not show that work causes diagnosable
diseases.--High quality studies of work-related MSDs have defined these
disorders through the same methods used by clinicians to diagnose
MSDs--a combination of history, physical examination findings, and, in
some cases, nerve conduction studies. The NIOSH review (Bernard 1997)
only considered studies where clinical case definitions included the
use of physical examinations as well as symptoms. The case definitions
used in much of the research on musculoskeletal disorders are similar
to the diagnostic methods used every day by clinicians.
Senator Specter. Thank you very much, Dr. Evanoff. Turn now
to Ms. Heidi Eberhardt, international trade specialist.
STATEMENT OF HEIDI EBERHARDT, INTERNATIONAL TRADE
SPECIALIST
Ms. Eberhardt. Good morning. My name is Heidi Eberhardt. I
am from Boston, Massachusetts, and I want to thank you for
inviting me to testify today.
Two and a half years ago, when I was 30 years old, I was
injured at my job from working on the computer. I was working
40 hours a week at a dot com internet publishing company. I was
an international trade specialist and my job consisted of using
the computer keyboard most 8 hours a day for writing, editing
and researching about Latin American countries, surfing the web
and e-mailing with foreign officials.
As an undergraduate at Dartmouth College, I majored in
Spanish and studied in Latin America. When I started this job 6
years ago, I was thrilled to have found work where I could put
my education to use. I was excited to be working in a cutting-
edge industry with the advanced computer technology that
allowed me to be more productive and perform my job more
efficiently.
I had never heard about repetitive strain injuries. I did
not know I could be injured from working on the computer. I did
not know what workers' compensation was.
I was a healthy and happy individual in all respects and
exercised regularly. I had no hobbies that were repetitive in
nature.
My company provided no education or training about
ergonomics or working safely on a computer. Our computer work
stations were not set up properly.
There was another young employee in our department who
after only working 3 months with us had already begun to
experience symptoms of repetitive strain injury from working at
the computer. I was diagnosed with bilateral tendonitis,
tenosynivitis, thoracic outlet syndrome and De Quervain's
thumb.
At first, my symptoms were merely annoying. My wrists would
ache and my hands felt clumsy. Then I started to notice
tingling and pain that persisted even at rest, even on the
weekends.
My pain and loss of dexterity became so severe that I could
no longer type or do anything on the computer, let alone
perform any hand-related tasks outside of work.
My doctor sent me out of work for 4 months, and I had to
file for workers' compensation. I was returned to light duty
for 12 hours a week, but my symptoms had not completely gone
away and I was still working in pain.
I since have switched to a job where I do not use a
computer, but even writing, looking through files or even
holding the phone still hurts my hands. So now at age 32, 2\1/
2\ years after being injured, I am still on workers'
compensation and still working only 12 hours per week. I am
greatly hindered in my ability to contribute in a productive
way to the workforce and am not paying taxes.
After college, I had spent several years mastering research
and writing skills. I was building a career, one that was
satisfying, productive and seemed to be full of potential.
I am now sitting before you, a young person faced with
having to find a new career that does not require a computer or
even much use of my hands. I am faced with reduced income and
increased medical expenses. I am faced with chronic pain which
affects my work productivity.
I have a restricted personal life and am unable to perform
daily chores outside of work without pain. I have had to endure
the stigma of being injured and on workers' compensation.
Doctors can tell me what my injury is. My tendons and
ligaments are damaged because of repetitive hand use of the
computer. No doctor can tell me if I will fully recover.
I am worried about my future and about whether I will ever
regain complete use of my hands. I am a single person and do
not have anyone to assist me with daily living, nor do I have
the financial resources to pay someone to help me.
I would like to get married and have children some day and
am worried about not being able to physically raise children.
Here are a few simple things I used to take for granted but
I now have difficulty with: Squeezing shampoo bottles,
toothpaste tubes, turning on and off faucets, clipping finger
and toe nails, driving, shifting gears, holding the steering
wheel, carrying groceries, cooking, carrying heavy pots,
opening cans, cutting things, putting away dishes, cutting my
food, opening milk cartons, making coffee, holding coffee,
getting ice cubes out of the ice tray, dressing myself,
buttoning my pants and my shirts, pulling things on, hanging up
clothes, doing laundry, carrying clothes to the laundromat,
pulling clothes in and out of the washer and dryer, folding
clothes, cleaning house, writing letters, writing checks for
bills, opening mail, opening doors and windows, turning my
house key in the lock or my car key in the ignition; in short,
almost anything you need your hands to do. And this list does
not include anything I might want to do for fun.
In March of last year, I testified at the public hearings
that OSHA held on its then proposed ergonomics standard. When
the ergonomics standard was issued last November, I was proud
of our government for recognizing and acting to prevent what I
now know is the Number 1 injury in the workplace, an injury
that I know about firsthand and have been trying to recover
from for 2\1/2\ years, an injury that has profoundly altered my
life and left me unable to work on the computer.
So when both houses of Congress voted to repeal the very
standard that would have prevented millions of devastating
injuries, I was deeply dismayed.
What was most disturbing was the manner in which it was
done. The votes were rushed through without any input from the
workers it would have protected. This action seemed only to put
the interests of corporations above the safety and health of
workers in this country. Millions of workers have suffered
ergonomic injuries over the past decade while waiting for
protections.
Senator Specter. Ms. Eberhardt, I have to remind you that
the time is up. If you could summarize, we would appreciate it.
prepared statement
Ms. Eberhardt. I know that companies who have put into
place ergonomic programs have been successful. They have
reduced costs. And I know that these ergonomics programs which
include simple education and training can prevent the kind of
injury that I have sustained and I strongly urge you to
continue your hard work.
[The statement follows:]
Prepared Statement of Heidi Eberhardt
My name is Heidi Eberhardt. I am an international trade specialist
from Somerville, Massachusetts. I am here today to tell you about an
injury that has changed my life.
In the Fall of 1998, when I was 30 years old, I was injured at my
job from working on the computer. I was working 40 hours a week at a
.com Internet publishing company. There were 8 employees in the
company, and I was working in the department responsible for
researching and writing about international trade issues.
My job as an international trade specialist consisted of writing,
researching, and editing which was performed 8 hours a days, 5 days a
week on the computer using a keyboard and a mouse. This included
typing, cutting and pasting, formatting, scrolling through 20 page
documents, surfing the web and corresponding via email with customers
and information providers. We had a heavy workload with weekly,
sometimes daily, deadlines. We were always behind. There was so much to
do, I stopped only for breaks to go to the restroom and to get my lunch
to eat at my desk while I was working.
As an undergraduate at Dartmouth College, I majored in Spanish and
studied in Latin America. When I started this job six years ago, I was
thrilled to have found work writing about Latin American countries
where I could put my education to use. I had never heard about
repetitive strain injuries. I did not know I could be injured from
working on the computer. I did not know what worker's compensation was.
I was a healthy and happy individual in all respects and exercised
regularly. I had no hobbies that were repetitive in nature.
In January of the same year I was injured, my company had switched
from Windows 3.1, with no internet or e-mail access, to Windows 1995
and a direct connection to the Internet, internal and external email,
and websurfing capabilities. I was happy that we could work faster and
perform more job tasks on the computer at once. With these new computer
programs there is no need to pause between tasks.
My company provided no education or training about ergonomics or
working safely on a computer. I've since learned that our computer
workstations were not set up properly. There was another young employee
in our department who, after working only three months with us, had
already begun to experience symptoms of repetitive strain injury from
working at the computer. Since being injured, I have received extensive
ergonomics education from occupational therapists. This education came
too late to prevent my injury, and it is information that most workers
will never hear without the types of workplace programs that OSHA tried
to put in place.
At first my symptoms were merely annoying. My wrists would ache and
my hands felt clumsy. Then I started to notice tingling, and pain that
persisted even at rest, even on the weekends. My pain and loss of
dexterity became so severe that I could no longer type or do anything
on the computer, let alone perform any hand-related tasks outside of
work.
At my doctor's and occupational therapists' insistence, I filed for
Worker's Compensation. My doctor, who had diagnosed me with bilateral
tendonitis, tenosynivitis and DeQuervain's syndrome, prescribed rest
and abstaining from work. After being out of work for 4 months, I
returned to light duty for 12-hours a week. But, my symptoms had not
completely gone away, and I was still working in pain. I since have
switched to a job where I do not use the computer, but even writing,
looking through files, or even holding the phone, still hurts my hands.
Now, at age 32, two and a half years after being injured, I am still on
worker's compensation, and still working only 12 hours per week. I am
greatly hindered in my ability to contribute in a productive way to the
workforce, and I am not paying taxes.
After college, I spent several years mastering research and writing
skills. I was building a career, one that was satisfying and productive
and seemed to be full of potential. I am now sitting before you, a
young person faced with having to find a new career that does not
require a computer or even much use of my hands--please imagine that if
you can. I am faced with reduced income and increased medical expenses.
I am faced with chronic pain which affects my work productivity. I have
a restricted personal life and am unable to perform daily chores
outside of work without pain. I have had to endure the stigma of being
injured and on worker's compensation. And I have suffered depression as
a result of dealing with the pain and uncertainties about my future.
Doctors can tell me what my injury is--my tendons and ligaments are
damaged because of repetitive hand use at the computer. No doctor,
however, can tell me when I will be fully recovered. I am worried about
my future and about whether I will ever regain complete use of my
hands. I am a single person and do not have anyone to assist me with
daily living, nor do I have the financial resources to pay someone to
help me. I would like to get married and have children someday and am
worried about not being able to physically raise children.
Here are a few simple things that I used to take for granted, but I
now have difficulty with:
--squeezing shampoo bottles, dishwashing detergent and toothpaste
tubes
--turning on and off faucets
--clipping finger and toe nails
--driving, shifting gears, holding the steering wheel
--carrying groceries
--cooking, carrying heavy pots, opening cans, cutting things, putting
away dishes
--cutting my food
--opening milk cartons, bottles, cans
--making coffee, holding coffee
--getting ice cubes out of the ice tray
--moving anything heavy
--dressing myself (buttoning pants and shirts and pulling things on)
--hanging up clothes
--doing laundry (carrying clothes to laundromat, pulling clothes in
and out of washer/dryer, folding clothes)
--cleaning house (washing counters, bathrooms, vacuuming)
--writing letters, grocery lists, etc.
--writing checks for bills
--opening mail
--opening doors and windows
--turning my house key in the lock, or my car key in the ignition
--picking up my 2-yr old nephew
In short, almost anything you need your hands to do, and this list
does not include anything I might want to do for fun, nor does it
include computer or work activities.
In March of last year I testified at the public hearings that OSHA
held on its then proposed ergonomics standard. When the ergonomics
standard was issued last November, I was proud of our government for
recognizing and acting to prevent what I know is the number one injury
in the workplace today. An injury that I know about first hand and have
been trying to recover from for two and a half years. An injury that
has profoundly altered my life and left me unable to work on the
computer. So when both houses of Congress voted to repeal the very
standard that would have prevented hundreds of thousands of serious
injuries, I was appalled. What was most outrageous was the manner in
which it was done. The votes were rushed through without any input from
the workers it would have protected. The action taken by Congress and
the President seemed only to put the interests of corporations above
the safety and health of workers in this country.
Millions of workers have suffered ergonomic injuries over the past
decade while waiting for protections. How many more workers need to
suffer these crippling injuries before this problem is addressed?
When I was first injured, I went to the Massachusetts Coalition on
New Office Technology (CNOT) because they offer resources to injured
workers. Now I work for CNOT part time, providing training on
ergonomics and injury prevention. Part of my work involves evaluating
employees' workstations. What I see in my work validates the
overwhelming need for a Federal ergonomics standard. More often than
not, workers are sitting in improperly set up workstations, with little
knowledge of the impact that this can have on their health, and as I
know first hand, their entire lives. What is even more frightening is
that close to 25 percent of the people I see already have symptoms of
injury.
These injuries can be prevented with programs that include
appropriate workstations and training for workers. Once an injury sets
in it is difficult, if not impossible, to reverse the damage. I implore
you to pass legislation that requires OSHA to issue a strong ergonomics
standard that covers workers in all industries and emphasizes
prevention of repetitive strain injuries. I am only 32, but I know
people who are in their early twenties, working in Internet companies
or as software engineers, who are injured.
Workers in this country desperately need an ergonomics standard to
prevent even more debilitating injuries from occurring. Too many
companies will not act to protect their employees unless required to by
law. I sincerely hope that my testimony today gives you a better idea
of what can happen to workers, including very young workers, in today's
computer-driven workplaces and how these injuries are affecting our
lives. Your work to pass this bill can prevent this story from being
told over and over again, by injured worker after injured worker. Thank
you for this opportunity to tell you my story.
Senator Specter. Thank you very much, Miss Eberhardt.
Mr. Fellner, do you think that it is realistic to expect a
consensus on the issues that are involved in ergonomics based
on the testimony we have heard here in this first panel?
Mr. Fellner. I think that we will not know the answer to
that question until a much more exhaustive analysis of the
issues that are touched on this morning has been had at the
Department of Labor.
Senator Specter. Dr. Bigos, you say there is no scientific
basis. You cannot diagnose and you cannot prevent. In the
absence of a scientific basis, your testimony is pretty plain
that from your professional expertise and in the absence of a
scientific basis and the cost of a regulation simply cannot
have one. Isn't that right?
Dr. Bigos. Well, I guess I am not sure I understand the
question you are asking me.
Senator Specter. Well, let me repeat the question. You
testified that there was no scientific basis for an ergonomics
regulation, did you not?
Dr. Bigos. Yes, I did.
Senator Specter. So how can you have an ergonomics
regulation without a scientific basis as you view this entire
issue?
Dr. Bigos. I do not think you can.
Senator Specter. That is my point. You do not think we can.
Dr. Bigos. No. Without knowing the dose and without knowing
how high or how much or some guidance in some way, I do not see
any way that we can really do that.
Senator Specter. Well, I understand your point. I was just
making sure that I understand it. You cannot have an ergonomics
regulation. Ms. Seminario?
Ms. Seminario. Seminario.
Senator Specter. In the absence of a scientific basis,
which Dr. Bigos testifies to, what basis do you have for
postulating a regulation besides, if anything, all of these
reports of work-related injuries?
Ms. Seminario. A couple of things, Senator. First, we do
think there is a scientific basis that is fairly extensive and
quite strong and certainly sufficient to regulate. There is
also the experience that employers and unions and others have
had dealing with these problems in the workplace which again is
quite extensive.
And we had encouraged the Labor Department and we would
still encourage the Labor Department to look to that experience
of employers in addressing these problems as the approach that
they should take to regulation.
I would also point out that this issue has been regulated.
There are regulations on manual handling, ergonomics, video
display terminal use that have been in place in the European
community for more than a decade. Many of the same employers
that obviously operate----
Senator Specter. Are they in place in Workman's
Compensation laws in the State level?
Ms. Seminario. Not the preventative aspects. Obviously
these injuries are----
Senator Specter. The diagnosed aspects?
Ms. Seminario. Yes. The diagnosed aspects certainly are and
the criteria in some of the states are quite similar to the
criteria and definitions laid out by OSHA.
Senator Specter. When I listened to the testimony of Dr.
Evanoff and Dr. Hadler, diametrically opposed, we have quite a
number of witnesses to hear, and I will reserve judgment; but
from what I have heard on this panel, Mr. Fellner, I do not see
a consensus emerging at all.
When you talk about, as Dr. Bigos does about nonphysical
factors outweighing physical factors on back pain, we have all
had some experience with lifting and pack pain.
My dad had a junk yard in Russell, Kansas. And it did not
take me a whole lot of time to figure out that lifting a 30-
foot joint of 3-inch tubing that weighed 300 pounds, and I was
lifting half of it, and maybe we do not need an ergonomics
regulation when my older brother one day told me to throw a
rock bed on top of a load of junk which weighed about 80
pounds, and I simply refused, having in mind the sciatica nerve
which he had injured and could not lift junk anymore.
He was smart enough to sustain an injury so he could avoid
the lifting. But we will wrestle through the problems. I would
like to call the second panel now. Dr. Burton, Dr. Punnett and
Dr. Mirer. I am sorry. Before the panel leaves, Miss Landrieu.
Senator Landrieu. The panel can go. The new panel can come.
But I will just make a brief statement, if I could.
Senator Specter. Okay. Fine. Pardon me Senator Landrieu,
for not noticing you.
You took a seat so far to the right.
There are at least two attributes about your appearance I
should have noted, and I will not specify them for the record.
Senator Landrieu. And I wore this bright red jacket so it
is hard to not notice me today. But I thank you, Mr. Chairman.
Senator Specter. It is hard not to notice you in the
absence of a red jacket.
Senator Landrieu. Thank you, Mr. Chairman. If the new panel
would just come forward, I do not want to stop you all from
moving forward. I do want to just make a couple of comments
though.
Senator Specter. Senator Landrieu, while you are making the
comments, I am going to excuse myself for a moment. We have
Secretary Manetta testifying in Transportation. I am going to
be gone for a very brief period of time. Senator Landrieu has
the floor and I shall return momentarily.
Opening statement of Senator Mary L. Landrieu
Senator Landrieu. Thank you, Mr. Chairman. I have a
statement I would like to submit to the record. And I would
like to ask unanimous consent. Since I am the only one here, I
am going to give myself unanimous consent to submit this to the
record.
But I would just want to make a few points, and then
unfortunately I am going to have to slip out for another
meeting myself, and some responsibilities on the floor.
I want to thank the chairman first of all for calling this
very important hearing because we need the chairman and our
ranking member to help us stay focused on this very important
issue so it does not slip off the radar screen.
I was briefed at some of the comments earlier made about
how important it is to develop a consensus. And we try very
hard to do that here in Washington on a number of different
issues, whether it has to do with health or transportation,
environmental issues. It is always desirable I think to build
consensus, but it is not necessary. What is necessary is a
majority, a majority to vote, to take an action.
We do not need a unanimous vote. We do not need always a
consensus. And many of the most important issues that have
moved through Congress in the history of this Nation have not
necessarily moved by consensus but they have in fact moved by a
majority.
And I wanted to just show up this morning to say to the
labor and business leaders and to the workers here that I
believe there is a majority of Republicans and Democrats today
that recognize that this is a serious problem in the United
States, that in fact these injuries are real. They are
affecting real people in real ways. And we heard some of that
testimony.
With all due respect to the scientists and to those
academics that would argue otherwise, I think we have passed
that point; that this is real and that there are a majority. We
do not have everyone. We do not need everyone. But there is a
majority of votes in the Senate and in the House to actually
produce a rule that will work to prevent, to try to prevent
these injuries.
What the challenge is, and I think what the question is
which is reflected in the vote that was cast just last week, is
that the rule that was presented before us either basically had
to be completely adopted or none of it could be adopted. The
procedure did not allow for us to sort of reshape that rule.
And so the vote occurred to reject it. But I hope there is
no one here in this room or around the country that would
interpret that vote as meaning that there are not a large
number of Republicans and Democrats, the majority here, to have
a rule that will help prevent these injuries and to address it.
There is a majority that agrees that this cannot be
voluntary, that while voluntary actions can in fact help, that
this needs to be, it is proper rule for government. It needs to
be mandatory. Workers have a responsibility themselves in this
regard as well as employers.
And so I want to commend the chairman for calling this
hearing to say that the challenge is now about how to present
to the country a new rule, one that will address some of the
concerns that were raised. But we are not going to go
backwards. We are going to continue to move forward.
And I hope because of the bill that I have introduced with
Senator Breaux and Senator Specter that that time frame could
be short, perhaps coming back with something in about 18 months
for the Congress to act on.
And let me say although I missed your testimony and I have
the greatest respect for our new Secretary and think that she
most certainly can do a wonderful job, I was somewhat
disappointed to hear that she was not more enthusiastic about
moving forward with a new rule.
And I hope that this bill that we have introduced is going
to encourage her in very direct ways to move forward with a new
rule within a short period of time, one that many employers
could embrace and many workers. We do not need all employers
but we need many of them.
And many that came to my office against the old rule said,
Senator, we are not opposed to the Government having mandatory
rules. We just want to make sure that we can understand it, we
can comply with it, that the workers have responsibilities as
well as we have responsibilities.
So I am going on their word, all the employers that came
into my office to testify to me in that regard. And I am going
to do everything I can as a Senator to insist that we move
forward way past the discussions about whether this is true or
not.
The American people understand these injuries are
happening. They are happening to them and their own families.
We can hear all the scientific testimony. We are past that
point. We are now about how to draft a good rule that works for
big employers, for small employers, that prevents these
injuries and gives real relief without perhaps overlapping too
much with what some states are doing to recognize the specific
role of States.
So I am sorry I do not have a whole list of questions. I
do, but I do not have the time for them. But I wanted to get
that statement into the record. And I thank you all.
If the staff will help me to continue to conduct this
meeting while the chairman is going, because I am going to have
to slip out in just a moment. But on behalf of Senator Murray
who could not be here, she did want me to recognize Dr. Bigos
from Washington, from the University of Washington, and to
welcome you in her absence because you are a constituent of
hers and she wanted me to mention that this morning.
But whoever would like to proceed with their testimony, and
then I think if other members show up they will have questions
or comments. Who should we begin with?
It has been recommended that we just take a 5-minute recess
until the chairman comes back. Thank you.
Senator Specter. We'll resume the hearing now with Dr. Kim
Burton, director of Spinal Research Unit, University of
Hudderfield, United Kingdom. Welcome.
STATEMENT OF DR. KIM BURTON, DIRECTOR, SPINAL RESEARCH
UNIT, UNIVERSITY OF HUDDERFIELD, UNITED
KINGDOM
Dr. Burton. Thank you, chairman. It is indeed a pleasure
and an honor to address this body on the controversial topic of
ergonomics. Recently in the United Kingdom, experts giving
evidence in litigation cases need to sign declaration that
their duty is to the Court rather than to the party instructing
them. It is in that spirit that I address my views to you.
My background encompasses both clinical science and
ergonomics. And as you said, currently I am the director of the
Spinal Research Unit at the University of Huddersfield. I am
also a registered European Ergonomist, and have prepared
reports and guidance for the Health and Safety Executive in the
United Kingdom.
It is vitally important to distinguish between the various
manifestations of musculoskeletal disorders. That is, they may
present as reports of symptoms, the filing of an injury claim,
the need for sick leave, the development of chronicity and
irreparable damage.
Each of these components is unique. And it is somewhat
unhelpful to talk about them as if they are fully
interchangeable.
Because low back pain is the area of my expertise and is
such a prominent target of OSHA's recent regulation, I will use
this as an example. Low back pain is not a discrete disease
entity or even a single clinical syndrome. It is a symptom, a
symptom experienced by most people during their lifetimes,
irrespective of employment.
General adult population surveys find a lifetime prevalence
of low back pain of around 60 percent, a 12-month prevalence of
over 40 percent, and a point prevalence of approximately 20
percent. The lifetime prevalence in adolescents, at just over
50 percent, is only slightly lower than that for working-age
adults. In the face of such figures, attribution of the bulk of
the symptoms to work, in my view, is untenable.
Nonspecific low back pain can be occupational in a sense
that it is common in adults of working age, frequently affects
capacity for work, and often prompts referral for occupational
health care. The common assumption that this means that low
back pain is necessarily caused by work, however, overlooks the
complex and inconsistent relationship between physical and
other influences.
The review that I coauthored with Professor Waddell last
year concluded that on the balance of the scientific evidence
that it showed physical demands of work can precipitate
individual attacks of back pain. Certain individuals may be
more susceptible and certain jobs may be at higher risk. But
viewed overall, physical demands of work only account for a
modest proportion of the total impact of back pain.
The development of chronic pain and disability, however,
depends more on individual or work-related psychosocial issues
than on physical or clinical features. People with physically
or psychologically demanding jobs may have more difficulty
working when they have low back pain and so lose more time from
work. But that can be the effect rather than the cause of their
back pain.
It is unrealistic to think that we can expect to prevent
all low back pain. What I understand to be OSHA's apparent
concept of making all work physically undemanding is not only
unsupported but may well have adverse effects. There is strong
chance of raising the profile of the attribution concept among
workers, their advisors and managers, which in turn could lead
to an exacerbation of the overall impact of low back pain on
society, rather than a reduction.
The state-of-the-art evidence assessing reductions in
physical exposures as a prescription for ergonomic concerns is
a comprehensive review from Linton and van Tulder. These
authors systematically searched the literature for studies
involving subjects not seeking treatment. One third of the
studies considered educational approaches, often including
training in lifting techniques, finding strong evidence that
they were ineffective. Much of the remaining literature studied
lumbar supports and back belts, again, negative findings.
The most telling finding of this review, however, is the
lack of control trials that consider job controls modifying so-
called risk factors such as force of repetition. We simply do
not have the scientific evidence yet that these measures are
effective.
I am not convinced that there is reliable evidence
supporting blanket ergonomics programs as a remedy for
musculoskeletal disorders. In fact, a regulation not dissimilar
to the issued proposal was introduced in Europe in the early
1990s.
This has had no discernible influence on disability due to
back pain. It may well be better to target our resources
towards appropriate management of the symptomatic worker,
taking steps to remove obstacles to recovery, both physical and
psychosocial, thus facilitating that worker's continued
comfortable performance of normal job duties.
prepared statement
Senator Specter. Dr. Burton, your time has expired and we
have to be very close on that with so many witnesses. Your full
statement will be made part of the record. And if you would
summarize, we would appreciate it.
Dr. Burton. That was it. I have finished, sir.
[The statement follows:]
Prepared Statement of Dr. Kim Burton
It is a pleasure to address this body on the very controversial
topic of ergonomics. Recently in the United Kingdom, experts giving
evidence in litigation cases need to sign a declaration that their duty
is to the Court rather than to the party instructing them. It is in
this spirit that I present my views to you. My background encompasses
both biomedical science and ergonomics. Currently, I am Director of the
Spinal Research Unit at the University of Huddersfield in the United
Kingdom and I serve as Editor-in-Chief of Clinical Biomechanics, a
biomedical journal listed in Index Medicus. I am also a registered
European Ergonomist, and have prepared reports and guidance for the
Health & Safety Executive in the United Kingdom. Last year, in
collaboration with Professor Gordon Waddell, I produced what
commentators have called the most comprehensive and current review of
the evidence related to occupational aspects of low back pain.\1\
---------------------------------------------------------------------------
\1\ Occupational Health Guidelines for the Management of Low Back
Pain at Work, Evidence Review and Recommendations (March 2000)
(available at www.facoccmed.ac.uk).
---------------------------------------------------------------------------
The first question posed in this hearing is the nature of the
problem, including: ``What types of injuries?'' and ``Who suffers these
injuries?'' This very articulation, however, oversimplifies the
enquiry. It is vitally important to distinguish between reports of
symptoms, reports of alleged but medically untested ``injuries'' such
as filing an injury claim, sick leave, chronicity, and irreparable
damage--all of which are brought together under the same umbrella. It
is also important to recognize that the term ``musculoskeletal
disorders'' or ``MSDs,'' as discussed by OSHA, includes a nearly
innumerable body of reported conditions, some of which involve a
discrete pathology whilst others are characterized only by their
symptoms. Each of these components is unique, and it is somewhat
unhelpful to talk about them as if they are fully interchangeable.
There is one common thread, however, and that is the compelling
evidence of multifactorial influences, including those which are
unrelated to work.
Because low back pain is the area of my expertise and is such a
prominent target of OSHA's recent regulation, I will use this as an
example. Low back pain is not a discrete disease entity or even a
single clinical syndrome; it is a symptom. Low back pain, in fact, is a
symptom experienced by most people during their lifetimes, irrespective
of employment. General adult population surveys find a lifetime
prevalence of low back pain of around 60 percent, a 12-month prevalence
of over 40 percent and a point prevalence of approximately 20 percent.
The lifetime prevalence in adolescents, at just over 50 percent, is
only slightly lower than that for working-age adults. In the face of
such figures, attribution of the bulk of the symptoms to work is, in my
view, untenable. It becomes exceedingly difficult to identify any
specific causative agents.
Non-specific low back pain can be occupational in the sense that it
is common in adults of working age, frequently affects capacity for
work and often prompts referral to occupational health care. The common
assumption that this means low back pain is caused by work, however,
overlooks the complex and inconsistent relationship of physical and
other influences. Workers in heavy manual jobs do report somewhat more
low back symptoms and jobs with greater physical demands commonly have
a higher rate of reported low back injuries, but most of these
``injuries'' are associated with normal everyday activities such as
bending and lifting and there is usually little if any objective
evidence of tissue damage. The review I coauthored with Professor
Waddell, which considered 34 existing systematic reviews, 28 narrative
reviews, 52 individual scientific studies, 22 additional weaker
scientific studies and 17 previous guidelines. We concluded that the
balance of the evidence showed that physical demands of work can
precipitate individual attacks of back pain, certain individuals may be
more susceptible and certain jobs may be higher risk but, viewed
overall, physical demands of work only account for a modest proportion
of the total impact of back pain occurring in workers.
Whether low back symptoms are attributed to work, are reported as
``injuries,'' or lead to requests for health care or time off of work
depends upon a complex combination of individual psychosocial and work
organisational factors. The development of chronic pain and disability
depends more on individual and work-related psychosocial issues than on
physical or clinical features. People with physically or
psychologically demanding jobs may have more difficulty working when
they have low back pain and so lose more time from work, but that can
be the effect rather than the cause of their pain.
It is unrealistic to think, therefore, that we are even close to
the point at which we can expect to prevent low back pain. What I
understand to be OSHA's apparent concept of making all work physically
undemanding is not only unsupported, but may well have adverse effects
by exacerbating the psychosocial influences that are now known to be
important determinants of MSDs in the workplace. There is a strong
chance of raising the profile of the ``attribution'' concept among
workers, their advisors and managers, which in turn would likely lead
to an exacerbation of the overall impact of low back pain on society
rather than a reduction.
The state-of-the-art evidence assessing reductions in physical
exposures as a prescription for ergonomic concerns is a comprehensive
review from Steven J. Linton and Maurits van Tulder entitled
``Preventive Interventions for Back and Neck Pain Problems: What is the
Evidence?'' \2\ The authors of this review systematically searched the
literature for investigations that specifically considered a
preventative intervention using randomized or non-randomized controlled
trials involving subjects not seeking treatment. Twenty-seven such
studies were found, none of which focused on the physical workplace
environment. One-third of the studies considered educational approaches
(often including training in lifting techniques), finding ``strong
evidence'' that these ``back schools'' are ineffective. Much of the
remaining literature studied lumbar supports such as back belts,
yielding consistently negative findings. Exercise programs aimed at
improving conditioning showed stable positive evidence of relatively
moderate utility, but issues such as compliance and individual need
suggest they are not justified for use as a universal remedy. The most
telling finding, however, is the lack of any controlled trials--
randomized or otherwise--that consider ``job controls'' modifying so-
called ``risk factors'' such as force or repetition. We simply do not
have the scientific evidence yet that these measures are effective.
---------------------------------------------------------------------------
\2\ Institute for Research in Extramural Medicine, Free University,
Amsterdam, Netherlands.
---------------------------------------------------------------------------
Such evidence, in my opinion, is essential. Anecdotal evidence of
ergonomic ``successes'' is often cited, but these claims raise more
questions than they answer. It is difficult to determine in many cases
exactly what the employer has done and how that can be translated into
a regulation. Another important issue is that such studies have used
different measurements by which ``success'' is claimed (e.g. absence,
injury reports, prevalence rates). Interventions may be said to have
some effect on absence rates, but in most cases these appear to be the
outcome of organisationally-based factors such getting all the players
on one side, rather than the product of reductions in physical demands.
Without any way to separate out and test these influences, which
requires carefully designed controlled trials, it becomes impossible to
determine the optimal strategy.
Scientists have likewise been unable to develop any reliable
quantified relationships between exposure to ``risk factors'' and
negative health outcomes. We are simply not at the point yet where we
can offer a legitimate work-damage model to guide employer conduct, and
we are unlikely to reach that point anytime soon. Ergonomics
researchers face particularly difficult challenges: measuring exposures
in diverse workplaces, accurately diagnosing the response for outcomes
such as low back pain that do not manifest objective tissue damage, and
selecting interventions that might offer benefit for substantial
numbers of workers. Science, after considerable effort, has failed to
identify any instances where exposure-response relationships are
universally agreed to be positively and accurately quantified. It is
difficult to conceive how a workable standard could be applied in the
absence of such guidance.
I am not convinced that there is reliable evidence supporting
blanket ergonomics programs as a remedy for ``MSDs.'' It may well be
proper to target resources toward appropriate management of the
symptomatic worker, taking steps to remove obstacles to recovery (both
physical and psychosocial) by facilitating that worker's continued
comfortable performance of normal job duties. Even then, it is
imperative that physical measures be temporary and not a permanent
crutch that will impede the worker's return to full function. Helping a
worker get back to the job in this fashion, however, is a far cry from
using mandatory and potentially permanent job modifications to prevent
injuries. The latter alternative, in my opinion, is scientifically
unsupported and dangerously counterproductive. Whatever OSHA does as a
next step, therefore, I would hope it will not fall into the trap of
continued fixation on physical exposures as the key to solving the
problem.
Senator Specter. Thank you. We should have begun with Dr.
Jeremiah Barondess, chairman of the MSD Panel, National
Research Council, IOM, and president of the New York Academy of
Medicine. Thank you for joining us, Dr. Barondess. And the
floor is yours.
STATEMENT OF DR. JEREMIAH A. BARONDESS, CHAIRMAN, PANEL
ON MUSCULOSKELATAL DISORDERS AND THE
WORKPLACE, AND PRESIDENT OF THE NEW YORK
ACADEMY OF MEDICINE
Dr. Barondess. Thank you very much, Senator. It is a
privilege to be here. On behalf of the panel, my statement is
before you and it will be included in the record. And I wish to
emphasize a few points in it in the course of this
presentation.
This study was conducted by a panel put together by the
National Academy of Sciences and it consisted of 19 nationally-
recognized experts in the relevant scientific fields. The study
took 2 years and was requested. It was requested of us at the
outset that it take 2 years. We had then ample opportunity to
be comprehensive.
I wish to emphasize that what is presented in this report
is not the personal opinion of anyone.
Senator Specter. They gave you a deadline?
Dr. Barondess. They requested that we not hurry. I would
put it that way. Two years was the request.
Senator Specter. But they gave you a deadline?
Dr. Barondess. Yes, sir. Yes, sir. Once again, this report
represents the synthesis of the best thinking of people expert
in the relevant fields. We were essentially asked to look only
at the science, not policy, and to answer two questions. The
first is, does the scientific evidence support the contention
that the workplace adds incremental risk of musculoskeletal
disorders of the low back and upper extremities; not is it the
entire cause of all such syndromes but is there incremental
risk.
The second question was: Is there a scientific basis for
the contention that interventions of some sorts and some
circumstances are effective. The answer to both questions is
yes, in the view of the committee.
I would like to emphasize that this review was rigorous, as
it had to be. A lot of the literature in this field is weak.
Some of it is easy to dismiss on scientific grounds.
The Commission reviewed more than 3,600 studies and reviews
relevant to the fields of mechanobiology, biomechanics and
epidemiology as well as some clinical literature, and culled
from those papers some 25 percent so that there was a
significant filter in the literature that was reviewed.
In addition to the literature reviews, we had numerous
informed presentations by representatives of industry, of
labor, and various others.
The committee went to two heavy industry plants, kindly
given access by the Ford Motor Company, and visited those for a
full day. And finally, there were open fora for the expression
of opinions by industry, labor and professional bodies.
The conclusions of the 2-year study of the scientific basis
that we were asked to review can be very quickly summarized.
The first conclusion is as you have heard this is a very
important national health problem. It accounts for some 70
million office visits to physicians annually, not all of it
obviously specifically work-related. And it costs something of
the order of 1 percent of the gross domestic product of the
nation.
Second, the question of whether it is possible to compare
the incidents in the workforce to the incidents in the general
population cannot be approached. Because more than 80 percent
of American adults are in the workforce.
Third, the committee took the position that workplace
disorders and individual risk and outcomes are inextricably
bound, and therefore these disorders should be approached in
the context of the whole person rather than strictly the
injured structure. It is the structure that gets injured, it is
person who gets disabled.
Additionally, the committee concluded that the weight of
the evidence does justify the evidence, the identification of
certain work-related risk factors for the occurrence of
musculoskeletal disorders. For the low back these include heavy
lifting, that is significant physical loads, load moment, which
is the distance from the person at which the load to be lifted
is positioned, frequent bending, twisting and whole body
vibration; and for the upper extremity, repetition, force and
vibration.
The committee concluded that psychosocial factors are in
fact also very important in addition to the physical factors. I
appreciate Mr. Fellner putting up two of our illustrations
demonstrating the complexity of human beings. The complexity of
humans in these regards does not mean, however, that the
problem cannot or should not be approached.
The committee concluded also that the weight of the
evidence justifies the introduction of appropriate and selected
interventions, that the scientific basis is there. It is not as
robust as we would like but it is sufficient for action.
Some of these interventions should apply ergonomic
principles to reduce physical as well as psychosocial
stressors. These things have to be applied carefully in a
sharply selective manner, should be scientifically based and
should be periodically evaluated.
There is no generic solution to these problems. They must
be tailored to the specifics of the workplace and the tasks
involved in the job.
prepared statement
The committee also concluded that the entire field would
benefit from an enhanced information base. There is no science
base anywhere that is complete. That includes this one. And
additional research would help in the nuancing of responses. I
thank you for your attention, Mr. Chairman.
[The statement follows:]
Prepared Statement of Dr. Jeremiah A. Barondess
Good morning, Mr. Chairman and members of the Committee. My name is
Dr. Jeremiah Baroness. I am the President of the New York Academy of
Medicine and Chairman of the Panel on Musculoskeletal Disorders and the
Workplace. I am accompanied by committee member Dr. David Wegman,
Professor and Chair of the Department of Work Environment at the
University of Massachusetts at Lowell.
panel composition
The Panel on Musculoskeletal Disorders and the Workplace was
established by the National Research Council (NRC) and the Institute of
Medicine (IOM) in January, 1999, to conduct a two-year study of the
contribution of workplace physical and psychosocial factors to the
occurrence of musculoskeletal disorders of the low back and upper
extremities and to examine the effectiveness of various prevention
strategies. The panel is composed of 19 experts representing the fields
of biomechanics, epidemiology, hand surgery, human factors engineering,
internal medicine, nursing, occupational medicine, orthopedics,
physical medicine and rehabilitation, physiology, psychology,
quantitative analysis, and rheumatology.
impetus
The impetus for the study was a request from Congress (including
your subcommittee) to examine the causation, diagnosis, and prevention
of musculoskeletal disorders (House Report 105-635). The congressional
request was presented in the form of seven questions. The charge to the
panel, prepared by the NRC and the IOM, was stated as a series of tasks
designed to provide a comprehensive review of the science base and to
address the issues outlined in the congressional questions. A complete
statement of the panel's charge, approach, conclusions, and
recommendations is found in the first attachment: the Executive Summary
of the final report. Attachment App. A provides the panel's response to
the congressional questions.
approach
The panel approached the complex of factors bearing on the risk of
musculoskeletal injury in the work setting from a whole-person
perspective, that is, from a point of view that does not isolate
disorders of the low back and upper extremities from physical and
psychosocial factors in the workplace, from the context of the overall
texture of the worker's life, including social support systems at work
and in the community and physical and psychosocial stresses outside the
workplace, or from personal responses to pain and individual coping
mechanisms. The focus of the study was on work-related factors.
Individual factors and activities outside of the workplace were
considered as context and were accounted for in the literature reviews.
Our task was to determine the incremental effect of work-related
factors on the occurrence of musculoskeletal disorders.
The panel applied a set of rigorous scientific criteria in
selecting the research studies for its review. Because the literature
includes both empirical and theoretical approaches and covers a wide
variety of research designs, measurement instruments, and methods of
analysis, the quality selection criteria varied somewhat among
disciplines. At one level, there are highly controlled studies of soft
tissue responses to specific exposures using cadavers, animal models,
and human subjects. At another level, there are surveys and other
observational epidemiologic studies that examine the association among
musculoskeletal disorders and work, organizational, social, and
individual factors. At yet another level, there are experimental and
quasi-experimental studies of human populations designed to examine the
effects of workplace interventions. Studies at each level have
attendant individual strengths; each also has limitations when
considered in isolation. When taken together however, they provide a
rich basis for understanding the causes and prevention of
musculoskeletal disorders.
dimensions of the problem
The first conclusion reached by the panel is that musculoskeletal
disorders of the low back and upper extremities are an important
national health problem, resulting in approximately 1 million people
losing time from work each year. These disorders impose a substantial
economic burden in compensation costs, lost wages, and productivity.
Conservative cost estimates vary, but a reasonable figure is about $50
billion annually in work-related costs--a figure representing
approximately 1 percent of GDP.
The panel found that estimates of incidence in the general
population, as contrasted with the working population, are unreliable
because more than 80 percent of the adult population in the United
States is in the workforce. Nevertheless, the magnitude of the problem
of work-related musculoskeletal disorders can be gleaned from the
Bureau of Labor Statistics data. These data suggest that
musculoskeletal disorders are a problem in multiple industrial sectors;
they are not limited to the traditional heavy labor environments
represented by agriculture, mining, and manufacturing. It was reported,
for example, that the service sector is also importantly involved,
accounting for 26 percent of sprains/strains, carpal tunnel syndrome,
or tendinitis; the manufacturing sector accounted for 22 percent.
Another data base, National Center for Health Statistics, using self
reports, provided estimates for back pain among those whose pain
occurred at work (approximately 11.7 million) and for those who
specifically reported that their pain was work-related (5.6 million).
In this survey, the highest-risk occupations among men were
construction laborers, carpenters, and industrial truck and tractor
equipment operators; among women, the highest-risk occupations were
nursing aides/orderlies/attendants, licensed practical nurses, maids,
and janitor/cleaners. Other high-risk occupations were hairdressers and
automobile mechanics.
relationship among work factors and musculoskeletal disorders
A second major conclusion is that the weight of the evidence
justifies the identification of certain work-related risk factors for
the occurrence of musculoskeletal disorders of the low back and upper
extremities.
--The panel concludes that there is a clear relationship between back
disorders and physical load; that is, manual material handling,
load moment, frequent bending and twisting, heavy physical
work, and whole-body vibration. For disorders of the upper
extremities, repetition, force, and vibration are particularly
important work-related factors. That is, physical workplace
activities have been shown to be responsible for a significant
increment in the occurrence of musculoskeletal disorders of the
low back and upper extremities.
--Work-related psychosocial factors recognized by the panel to be
associated with low back disorders include rapid work pace,
monotonous work, low job satisfaction, low decision latitude,
and job stress. High job demands and high job stress are work-
related psychosocial factors that are associated with the
occurrence of upper extremity disorders.
the value of workplace interventions
A third major conclusion is that the weight of the evidence
justifies the introduction of appropriate and selected interventions in
the workplace to reduce the risk of musculoskeletal disorders of the
low back and upper extremities. These include, but are not confined to,
the application of ergonomic principles to reduce physical as well as
psychosocial stressors. To be effective, intervention programs should
include employee involvement, employer commitment, and the development
of integrated programs that address equipment design, work procedures,
and organizational characteristics.
There is no generic solution. To be effective interventions must be
tailored to the specific work and worker conditions and must be
evaluated on a continuing basis to account for changing workplace and
worker factors.
Cost and effectiveness of various intervention strategies are a
major concern for public and private policy makers, managers, and other
leaders facing the practical challenges of allocating limited
resources. Despite the availability of cost benefit analysis techniques
they have not been systematically applied to the study of workplace
interventions designed to relieve or prevent musculoskeletal disorders.
Outcome measures generally include relief from pain and loss of
function and reductions in worker's compensation claims and time away
from work. Although there are individual studies that demonstrate
favorable outcomes following the introduction of an intervention, the
conditions under which the data are collected make it difficult to
determine which of several specific factors are responsible for the
outcome. On the other side of the equation are the costs associated
with the design and implementation of the interventions. Some
interventions require minor changes in procedures or layouts for
specific work spaces while others may involve developing large-scale
design modifications or instituting new work practices or ways to
organize work. Here again, some scattered individual studies exist.
What is needed to resolve these issues is careful research to develop a
methodology to facilitate both cost and benefit comparisons across
alternative interventions in a range of workplaces.
the need for data collection and reporting systems
To extend the current knowledge base relating both to risk and
effective interventions, the Bureau of Labor Statistics should continue
to revise its current data collection and reporting system to provide
more comprehensive surveillance of work-related musculoskeletal
disorders. Specific attention should be given to revising the illness
and injury coding system, refining the quantification of risk, and
developing denominator data for job-specific demographic features.
Reporting should also be enhanced to include details on musculoskeletal
disorders that do not involve lost workdays. Enhanced resources are
needed to address these recommendations.
The National Center for Health Statistics and the National
Institute for Occupational Safety and Health should include measures of
work exposures and musculoskeletal disorder outcomes in ongoing Federal
surveys (e.g., the National Health Interview Surveys, the National
Health and Nutritional Examinations), and NIOSH should repeat, at least
decennially, the National Occupational Exposure Survey. NIOSH should
develop both a passive surveillance packages for use by a broad range
of employees and a model for an active surveillance program for
interested employers.
The National Institute for Occupational Safety and Health should
take the lead in developing uniform definitions of musculoskeletal
disorders for use in clinical diagnosis, epidemiologic research, and
data collection for surveillance systems. These definitions should (1)
include clear and consistent endpoint measures, (2) agree with
consensus codification of clinically relevant classification systems,
and (3) have a biological and clinical basis.
a research agenda
The panel recommends a research agenda that includes developing (1)
improved tools for exposure assessment, (2) improved measures of
outcomes and case definitions for use in epidemiologic and intervention
studies, and (3) further quantification of the relationship between
exposures and outcomes. Also included are suggestions for studies in
each topic area: tissue mechanobiology, biomechanics, psychosocial
stressors, epidemiology, and workplace interventions. In addition, the
panel recommends (1) expanding research and research training, (2)
promoting collaboration among industry, labor, and academia, and (3)
expanding education and training in utilizing workplace interventions
to employers. In order to accomplish these objectives, the panel
recognized that funding for NIOSH would have to be significantly
increased. Broader support for these research programs should also be
sought from relevant NIH Institutes.
the dissent
The conclusions and recommendations provided in the panel's report
were supported by 18 of the 19 panel members. The dissenting member, a
hand surgeon, prepared a statement that was limited to a very narrow
concern--the relationship between carpal tunnel syndrome and
keyboarding. Unfortunately, he uses this case to question the
scientific basis for the panel's review and interpretation of all of
the literature. Essentially, he asserts that because the relationship
between low force, high repetition activities and muscusloskeletal
disorders is weak, the relationship between any work and the occurrence
of a musculoskeletal disorder may not be sound.
Some key points in the dissent assert that the panel used an
unscientific approach to the literature review, that it over-reached in
interpreting the literature on the relationship between keyboarding and
carpal tunnel syndrome, and that it recommends ergonomics as an
exclusive remedy for musculoskeletal disorders. All of these assertions
are countered in the panel's response to the dissent (see Attachment
App. C). It is important to note that many of the research studies
cited by the dissenting member in his discussion of the epidemiology of
carpal tunnel syndrome and work did not meet the rigorous review
criteria established by the panel and were rejected for inclusion in
the full report. Furthermore, one of the 18 panel members is a leading
and highly regarded hand surgeon and an enthusiastic supporter of the
panel's conclusions and recommendations.
Mr. Chairman, I want to thank you for the opportunity to provide
testimony on this important topic. I will be happy to answer any
questions.
Musculoskeletal Disorders and the Workplace--Low Back and Upper
Extremities
executive summary
There is no doubt that musculoskeletal disorders of the low back
and upper extremities are an important and costly national health
problem. Musculoskeletal disorders account for nearly 70 million
physician office visits in the United States annually and an estimated
130 million total health care encounters including outpatient,
hospital, and emergency room visits. In 1999, nearly 1 million people
took time away from work to treat and recover from work-related
musculoskeletal pain or impairment of function in the low back or upper
extremities. Conservative estimates of the economic burden imposed, as
measured by compensation costs, lost wages, and lost productivity, are
between $45 and $54 billion annually. There is some variation in
estimates of occurrence and cost as a result of inconsistencies within
and across existing databases. The ability to better characterize the
magnitude of the problem and formulate targeted prevention strategies
rests on improved surveillance and more rigorous data collection.
There is also debate concerning sources of risk, mechanisms of
injury, and the potential for intervention strategies to reduce these
risks. The debate focuses on the causes, nature, severity, and degrees
of work-relatedness of musculoskeletal disorders as well as the
effectiveness and cost-related benefits of various interventions. None
of the common musculoskeletal disorders is uniquely caused by work
exposures. They are what the World Health Organization calls ``work-
related conditions'' because they can be caused by work exposures as
well as non-work factors. There are a number of factors to be
considered: (1) physical, organizational, and social aspects of work
and the workplace, (2) physical and social aspects of life outside the
workplace, including physical activities (e.g., household work, sports,
exercise programs), economic incentives, and cultural values, and (3)
the physical and psychological characteristics of the individual. The
most important of the latter include age, gender, body mass index,
personal habits including smoking, comorbidities, and probably some
aspects of genetically determined predispositions. In addition,
physical activities away from the workplace may also cause
musculoskeletal syndromes; the interaction of such factors with
physical and psychosocial stresses in the workplace is a further
consideration. The task herein is to evaluate the significance of the
risk factors that result from work exposure while taking into account
the different types of individual and non-work factors. The complexity
of the problem is further increased because all of these factors
interact and vary over time and from one situation to another. Research
is needed to clarify such relationships, but research is complicated by
the fact that estimates of incidence in the general population, as
contrasted with the working population, are unreliable because the two
overlap: more than 80 percent of the adult population is in the
workforce.
The panel approached the complex of factors bearing on the risk of
musculoskeletal injury in the work setting from a whole-person
perspective, that is, from a point of view that does not isolate
disorders of the low back and upper extremities from physical and
psychosocial factors in the workplace, from the context of the overall
texture of the worker's life, including social support systems and
physical and psychosocial stresses outside the workplace, or from
personal responses to pain and individual coping mechanisms (see Figure
ES.1). The size and complexity of the problem and the diversity of
interests and perspectives--including those of medical and public
policy professionals, behavioral researchers, ergonomists, large and
small businesses, labor, and government agencies--have led to differing
interpretations of the evidence regarding the work-relatedness of
musculoskeletal disorders of the low back and upper extremities and the
impact of interventions. As a result, Congress requested a study by the
National Research Council and the Institute of Medicine covering the
scientific literature on the causation and prevention of these
disorders. The congressional request was presented in the form of seven
questions, which are addressed in Appendix A of this report. The
funding for the study was provided by the National Institute for
Occupational Safety and Health (NIOSH) and by the National Institutes
of Health (NIH).
Figure ES.1.--A conceptual model of the possible roles and
influences that various factors may play in the development of
musculoskeletal disorders. The dotted box outline on the right indicate
the possible pathways and processes that could occur within the person,
including the biomechanical load-tolerance relationship and the factors
that may mediate the load-tolerance relationship, such as individual
factors and adaptation. Outcomes may be a result of this relationship
and may be influenced by individual factors, such as conditioning or
psychological state. The dotted box on the left indicates the possible
influences of the workplace on the sequence of events that can lead to
musculoskeletal disorders in the person. Arrows between ``the
workplace'' factors and ``the person'' box indicate the various
research disciplines (epidemiology, biomechanics, physiology, etc.)
that have attempted to explain the relationship. For example,
epidemiology typically searches for associations between external
loading characteristics and reported outcomes, whereas the relationship
between external loads and biomechanical loading are usually explored
via biomechanical studies (adapted from National Research Council,
1999b).
panel charge, composition, and approach
The charge to the panel from NIOSH and NIH, which appears in Box
ES.1, was to undertake a series of tasks that would lead to a detailed
analysis of the complex set of factors contributing to the occurrence
in the workplace of musculoskeletal disorders of the low back and upper
extremities and that would provide the information necessary to address
the questions posed by Congress. The panel viewed this charge as an
opportunity to conduct a comprehensive review and interpretation of the
scientific literature, with the goal of clarifying the state of
existing knowledge concerning the roles of various risk factors and the
basis for various efforts bearing on prevention. The focus of the study
was on work-related factors. In this context, individual risk factors,
such as age, body mass index, gender, smoking, and activities outside
the workplace, were considered as sources of confounding and were
accounted for in the research reviews.
The panel was composed of 19 experts representing the fields of
biomechanics, epidemiology, hand surgery, human factors engineering,
internal medicine, nursing, occupational medicine, orthopedics,
physical medicine and rehabilitation, physiology, psychology,
quantitative analysis, and rheumatology. The panel's work was guided by
two underlying principles. The first, noted above, was to approach
musculoskeletal disorders in the context of the whole person rather
than focusing on body regions in isolation. The second was to draw
appropriate scientific inferences from basic tissue biology,
biomechanics, epidemiology, and intervention strategies in order to
develop patterns of evidence concerning the strength of the
relationship between musculoskeletal disorders and the multiplicity of
work and individual factors.
The panel applied a set of rigorous scientific criteria in
selecting the research studies for its review. Because the literature
includes both empirical and theoretical approaches and covers a wide
variety of research designs, measurement instruments, and methods of
analysis, the quality selection criteria varied somewhat among
disciplines (see Chapter 1 for details). At one level, there are highly
controlled studies of soft tissue responses to specific exposures using
cadavers, animal models, and human subjects. At another level, there
are surveys and other observational epidemiologic studies that examine
the association among musculoskeletal disorders and work,
organizational, social, and individual factors. At yet another level,
there are experimental and quasi-experimental studies of human
populations designed to examine the effects of workplace interventions.
Each level provides a different perspective; together they provide a
complementary picture of how various workplace exposures may contribute
to the occurrence of musculoskeletal disorders. Although each level has
its attendant strengths and limitations when considered alone, together
they provide a rich understanding of the causes and prevention of
musculoskeletal disorders.
The wide and diverse body of literature addressing the work-
relatedness of musculoskeletal disorders suggests various pathways to
injury. Figure ES.1 summarizes the analytic framework used by the panel
to organize and interpret these various strands of research. This
framework is central to the panel's assessment, and it is used to
orient and structure the panel's report. The factors are organized into
two broad categories: workplace factors and characteristics of the
person that may affect the development of musculoskeletal disorders.
Workplace factors include the external physical loads associated with
job performance, as well as organizational factors and social context
variables. A person is the central biological entity, subject to
biomechanical loading with various physical, psychological, and social
features that may influence the biological, clinical, and disability
responses. The rationale underlying the figure is that there may be
many pathways to injury, and the presence of one pathway does not
negate nor suggest that another pathway does not play an important
role. The various pathways simply represent different aspects of the
workplace-person system.
patterns of evidence
The panel's review of the research literature in epidemiology,
biomechanics, tissue mechanobiology, and workplace intervention
strategies has identified a rich and consistent pattern of evidence
that supports a relationship between the workplace and the occurrence
of musculoskeletal disorders of the low back and upper extremities.
This evidence suggests a strong role for both the physical and
psychosocial aspects of work. There is also evidence that individual
factors, such as age, gender, and physical condition, are important in
mediating the individual's response to work factors associated with
biomechanical loading.
Back disorders and the workplace
Low back disorder risk has been established through epidemiologic
studies of work that involves heavy lifting, frequent bending and
twisting, and whole body vibration, as well as other risk factors. The
relative risks have been derived from a rigorous evaluation of the
literature and have been found to be strong and consistent. Strong
points in this research include control for confounding, temporal
association, and characterization of dose-response relationships; the
principal limitation is that a number of the studies are based on self-
reports of injury. The epidemiologic literature that specifically
quantifies heavy lifting shows the greatest risk for injury when loads
are lifted from low heights, when the distance of the load from the
body (moment) is great, and when the torso assumes a flexed, asymmetric
posture. Biomechanical studies reinforce the epidemiologic findings.
Studies in basic biology also describe the mechanisms involved in the
translation of spinal loading to tissue injury within the
intervertebral disc. In addition, the basic science literature has
described pathways for the perception of pain when specific structures
in the spine are stressed. Intervention studies have shown how lift
tables and lifting hoists are effective in mediating the risk of low
back pain in industrial settings. Since risk is lowered when the load
is changed from a heavy lift to a light lift, this finding is also
consistent with the rigorous epidemiologic findings.
In epidemiologic studies, psychosocial factors in the workplace
have also been found to play a role. Specifically, there is evidence
for a relationship between low back disorders and job satisfaction,
monotonous work, work pace, interpersonal relations in the workplace,
work demand stress, and the worker's perceived ability to work. In
addition, recent evidence from biomechanics studies points to a
mechanism whereby psychosocial stress contributes to increases in spine
loading. There is also evidence that exposure to psychosocial stressors
may result in greater trunk muscle activity independent of
biomechanical load. Some part of the variance in response described in
the biological and biomechanical literature appears to be explained by
individual host factors, such as age, gender, and body mass index. For
example, age and gender appear to play a role in determining the
magnitude of load to which a person's spine may be exposed before
damage would be expected.
Upper extremity disorders and the workplace
The pattern of evidence for upper extremity disorders, as for the
low back, also supports an important role for physical factors,
particularly repetition, force, and vibration. The most dramatic
physical exposures occur in manufacturing, food processing, lumber,
transportation, and other heavy industries, and these industries have
the highest rates of upper extremity disorders reported as work
related. Psychosocial factors were found to play a role in upper
extremity disorders as well, particularly high job stress and high job
demands. In addition, several epidemiologic studies of physical
exposures (force, repetition) and psychosocial exposure (perceived
stress, job demands) have documented an elevated risk of upper
extremity disorders among computer users. Nonwork-related anxiety,
tension, and psychological distress are also associated with upper
extremity symptoms. Biomechanical studies have shown that extraneural
pressure in the carpal tunnel is increased with hand loading and
nonneutral wrist postures. Basic science studies demonstrate that
extraneural pressures may lead to intraneural edema and fibrosis,
demyelination, and axon degeneration. These changes in nerve structure
may cause impairment of nerve function. The findings in the
intervention literature are congruent with those in the basic biology
and epidemiology literatures. There is strong support across these
bodies of work that high force and repetition are associated with
musculoskeletal disorders of the upper extremities; basic biology data
provide evidence of alteration in tissue structure. The intervention
literature supports the efficacy of tool and workstation design
changes, job rotation, and other interventions that directly address
these risk factors with regard to upper extremity symptomology.
Although the upper extremity literature is less well developed than
the literature on low back pain, an analogous set of themes emerges,
lending further support to the conclusion that external loads and
psychosocial factors associated with work influence outcomes. These
exposure-response associations persist when adjusted for individual
factors that may increase vulnerability, such as age, gender, and body
mass index. The basic biology and biomechanics studies provide a
plausible basis for the exposure-response relationships. The evidence
related to the efficacy of ergonomic interventions further supports
these relationships.
Interventions
Data from scientific studies of primary and secondary interventions
indicate that low back pain can be reduced under certain conditions by
engineering controls (e.g., ergonomic workplace redesign),
administrative controls (specifically, adjusting organizational
culture), programs designed to modify individual factors (specifically,
employee exercise), and combinations of these approaches. Multiple
interventions that actively involve workers in medical management,
physical training, and work technique education can also be effective
in controlling risk. Similarly, with respect to interventions for
musculoskeletal disorders of the upper extremities, some studies of
engineering controls for computer-related work (reducing static
postural loads, sustained posture extremes, and rapid motions, and
changing the designs of workstations and tools) have resulted in a
decrease in upper extremity pain reports. Studies of administrative
controls (modifying organizational culture by an emphasis on
participatory team involvement) have also reported success. For such
interventions, the commitment of management and the involvement of
employees have been important to success.
These findings are based on a research and development process that
tailors interventions to specific work and worker conditions and
evaluates, on a continuing basis, the effectiveness of these
interventions in the face of changing workplace and worker factors. It
is therefore neither feasible nor desirable to propose a generic
solution. The development and application of effective interventions
requires an infrastructure that supports (1) gathering data, through
surveillance and research, about the engineering, administrative, and
worker factors that affect the effectiveness of interventions; (2)
using these data to refine, implement, and assess alternative
interventions; and (3) translating knowledge from research to practice.
These efforts will benefit from cooperation and information exchange
among researchers, practitioners, and workers and managers in industry
and labor, government, and academia. These practices should be
encouraged and extended.
conclusions
Based on a comprehensive review and analysis of the evidence, as
described above, the panel has reached the following conclusions:
1. Musculoskeletal disorders of the low back and upper extremities
are an important national health problem, resulting in approximately 1
million people losing time from work each year. These disorders impose
a substantial economic burden in compensation costs, lost wages, and
productivity. Conservative cost estimates vary, but a reasonable figure
is about $50 billion annually in work-related costs.
2. Estimates of incidence in the general population, as contrasted
with the working population, are unreliable because more than 80
percent of the adult population in the United States is in the
workforce.
3. Because workplace disorders and individual risk and outcomes are
inextricably bound, musculoskeletal disorders should be approached in
the context of the whole person rather than focusing on body regions in
isolation.
4. The weight of the evidence justifies the identification of
certain work-related risk factors for the occurrence of musculoskeletal
disorders of the low back and upper extremities.
--The panel concludes that there is a clear relationship between back
disorders and physical load; that is, manual material handling,
load moment, frequent bending and twisting, heavy physical
work, and whole-body vibration. For disorders of the upper
extremities, repetition, force, and vibration are particularly
important work-related factors.
--Work-related psychosocial factors recognized by the panel to be
associated with low back disorders include rapid work pace,
monotonous work, low job satisfaction, low decision latitude,
and job stress. High job demands and high job stress are work-
related psychosocial factors that are associated with the
occurrence of upper extremity disorders.
5. A number of characteristics of the individual appear to affect
vulnerability to work-related musculoskeletal disorders, including
increasing age, gender, body mass index, and a number of individual
psychosocial factors. These factors are important as contributing and
modifying influences in the development of pain and disability and in
the transition from acute to chronic pain.
6. Modification of the various physical factors and psychosocial
factors could reduce substantially the risk of symptoms for low back
and upper extremity disorders.
7. The basic biology and biomechanics literatures provide evidence
of plausible mechanisms for the association between musculoskeletal
disorders and workplace physical exposures.
8. The weight of the evidence justifies the introduction of
appropriate and selected interventions to reduce the risk of
musculoskeletal disorders of the low back and upper extremities. These
include, but are not confined to, the application of ergonomic
principles to reduce physical as well as psychosocial stressors. To be
effective, intervention programs should include employee involvement,
employer commitment, and the development of integrated programs that
address equipment design, work procedures, and organizational
characteristics.
9. As the nature of work changes in the future, the central
thematic alterations will revolve around the diversity of jobs and of
workers. Although automation and the introduction of a wide variety of
technologies will characterize work in the future, manual labor will
remain important. As the workforce ages and as more women enter the
workforce, particularly in material handling and computer jobs,
evaluation of work tasks, especially lifting, lowering, carrying,
prolonged static posture, and repetitive motion, will be required to
guide the further design of appropriate interventions.
recommendations
1. The consequences of musculoskeletal disorders to individuals and
society and the evidence that these disorders are to some degree
preventable justify a broad, coherent effort to encourage the
institution or extension of ergonomic and other preventive strategies.
Such strategies should be science based and evaluated in an ongoing
manner.
2. To extend the current knowledge base relating both to risk and
effective interventions, the Bureau of Labor Statistics should continue
to revise its current data collection and reporting system to provide
more comprehensive surveillance of work-related musculoskeletal
disorders.
--The injury or illness coding system designed by the Bureau of Labor
Statistics should be revised to make comparisons possible with
health survey data that are based on the widely accepted ICD-9
and ICD-10 coding systems.
--The characterization of exposures associated with musculoskeletal
disorders should be refined, including enhanced quantification
of risk factors. Currently, exposure is based only on
characterization of sources of injury (e.g., tools,
instruments, equipment) and type of event (e.g., repetitive use
of tools) derived from injury narratives.
--Information collected from each employer should contribute to
specificity in denominators for jobs including job-specific
demographic features in the workplace, such as age, gender,
race, time on the job and occupation.
--Injury and illness information should include, in addition to the
foregoing demographic variables, other critical variables, such
as event, source, nature, body part involved, time on job, and
rotation schedule. Combining these with the foregoing variables
would, with appropriate denominator information, allow
calculation of rates rather than merely counts or proportions,
as is now the case for all lost-workday events.
--Resources should be allocated to include details on non-lost-
workday injuries or illnesses (as currently provided on lost-
workday injuries) to permit tracking of these events in terms
of the variables now collected only for lost-workday injuries
(age, gender, race, occupation, event, source, nature, body
part, time on job).
3. The National Center for Health Statistics and the National
Institute for Occupational Safety and Health should include measures of
work exposures and musculoskeletal disorder outcomes in ongoing Federal
surveys (e.g., the National Health Interview Surveys, the National
Health and Nutritional Examinations), and NIOSH should repeat, at least
decennially, the National Occupational Exposure Survey.
--To upgrade and improve passive industry surveillance of
musculoskeletal disorders and workplace exposures, the National
Institute for Occupational Safety and Health should develop
adaptable surveillance packages with associated training and
disseminate these to interested industries.
--To provide more active surveillance opportunity, the National
Institute for Occupational Safety and Health should develop a
model surveillance program that provides ongoing and advanced
technical assistance with timely, confidential feedback to
participating industries.
4. The National Institute for Occupational Safety and Health should
take the lead in developing uniform definitions of musculoskeletal
disorders for use in clinical diagnosis, epidemiologic research, and
data collection for surveillance systems. These definitions should (1)
include clear and consistent endpoint measures, (2) agree with
consensus codification of clinically relevant classification systems,
and (3) have a biological and clinical basis.
5. In addition to these recommendations, the panel recommends a
research agenda that includes developing (1) improved tools for
exposure assessment, (2) improved measures of outcomes and case
definitions for use in epidemiologic and intervention studies, and (3)
further quantification of the relationship between exposures and
outcomes. Also included are suggestions for studies in each topic area:
tissue mechanobiology, biomechanics, psychosocial stressors,
epidemiology, and workplace interventions. The research agenda is
presented in Chapter 12.
additional considerations
Because of the importance of continued data collection and research
to further elucidate the causes and prevention of musculoskeletal
disorders of the low back and upper extremities, the panel believes it
would be useful for relevant government agencies, including the
National Institute for Occupational Safety and Health, the Occupational
Safety and Health Administration, and the National Institute of
Arthritis and Musculoskeletal and Skin Diseases to consider the
following program initiatives.
1. Expanding research support and mechanisms to study
musculoskeletal disorders in terms of risk factors at work, early
detection, and effective methods of prevention and their cost
effectiveness. Some examples include:
--Developing new mechanisms and linkages among funding agencies
(e.g., the National Institute for Occupational Safety and
Health, the National Institute of Arthritis and Musculoskeletal
and Skin Diseases) to expand ongoing basic research on relevant
tissues (e.g., skeletal muscle, tendon, peripheral nerve) to
promote study of those parameters that are directly relevant to
work-related musculoskeletal disorders.
--Creating mechanisms to stimulate collaboration and cross-training
of researchers in the basic and applied sciences directly
relevant to work-related musculoskeletal disorders.
--Developing mechanisms to promote research jointly conducted by
industry and the relevant academic disciplines on work-related
musculoskeletal disorders.
2. Expanding considerably research training relevant to
musculoskeletal disorders, particularly with relation to graduate
programs in epidemiology, occupational health, occupational psychology,
and ergonomics, to produce additional individuals with research
training.
3. Expanding education and training programs to assist workers and
employers (particularly small employers) in understanding and utilizing
the range of possible workplace interventions designed to reduce
musculoskeletal disorders. In addition, consideration should be given
to expanding continuing education (e.g., NIOSH Education and Research
and Training Projects) for a broad range of professionals concerning
risk factors that contribute to musculoskeletal disorders inside and
outside the workplace.
4. Developing mechanisms for cooperative studies among industry,
labor unions, and academia, including:
--Establishing a database of and mechanism for communicating ``best
practices.''
--Providing incentives for industry and union cooperation with due
regard for proprietary considerations and administrative
barriers.
--Encouraging funding for such studies from industry, labor,
academia, and government sources.
5. Revising administrative procedures to promote joint research
funding among agencies.
6. Encouraging the exchange of scientific information among
researchers interested in intervention research through a variety of
mechanisms. Areas that could benefit include the development of (1)
research methodologies, especially improved measurement of outcomes and
exposures, covariates, and costs and (2) uniform approaches, allowing
findings to be compared across studies. In addition, periodic meetings
should be considered to bring together individuals with scientific and
``best practices'' experience.
In order to implement these suggestions, the scope of research and
training activities of the National Institute for Occupational Safety
and Health would have to be expanded and funding significantly
increased. In addition, other Federal agencies (e.g., the National
Institute of Arthritis and Musculoskeletal and Skin Diseases, the
National Institute of Mental Health) would have to broaden their
support of research programs examining musculoskeletal disorders and
the workplace. In the panel's view these steps deserve serious
consideration.
Appendix A.--Answers to Questions Posed by Congress
The questions below provided the impetus for the study. The charge
to the panel, prepared by the NRC and the IOM was to conduct a
comprehensive review of the science base and to address the issues
outlined in the questions. The panel's responses to the questions
follow.
Question. What are the conditions affecting humans that are
considered to be work-related musculoskeletal disorders?
Answer. The disorders of particular interest to the panel, in light
of its charge, focus on the low back and upper extremities. With regard
to the upper extremities, these include rotator cuff injuries (lateral
and medial) epicondylitis, carpal tunnel syndrome, tendinitis,
tenosynovitis of the hand and wrist (including DeQuervains' stenosing
tenosynovitis, trigger finger, and others) and a variety of nonspecific
wrist complaints, syndromes, and regional discomforts lacking clinical
specificity. With regard to the low back, there are many disabling
syndromes that occur in the absence of defined radiographic
abnormalities or commonly occur in the presence of unrelated
radiographic abnormalities. Thus, the most common syndrome is
nonspecific backache. Other disorders of interest include back pain and
sciatica due to displacement and degeneration of lumbar intervertebral
discs with radiculopathy, spondylolysis, and spondylolisthesis, and
spinal stenosis (ICD 9 categories 353-357, 722-724, and 726-729).
Question. What is the status of medical science with respect to
the diagnosis and classification of such conditions?
Answer. Diagnostic criteria for some of the musculoskeletal
disorders considered to be work-related and considered in this report
are clear-cut, especially those that can be supported by objective
ancillary diagnostic tests, such as carpal tunnel syndrome. Others,
such as work-related low back pain, are in some instances supported by
objective change, which must be considered in concert with the history
and physical findings. In the case of radicular syndromes associated
with lumbar intervertebral disc herniation, for example, clinical and
X-ray findings tend to support each other. In other instances, in the
absence of objective support for a specific clinical entity, diagnostic
certainty varies but may nevertheless be substantial. The clinical
picture of low back strain, for example, while varying to some degree,
is reasonably characteristic.
Epidemiologic definitions for musculoskeletal disorders, as for
infectious and other reportable diseases, are based on simple,
unambiguous criteria. While these are suitable for data collection and
analysis of disease occurrence and patterns, they are not appropriate
for clinical decisions, which must also take into account personal,
patient-specific information, which is not routinely available in
epidemiologic databases.
Question. What is the state of scientific knowledge, characterized
by the degree of certainty or lack thereof, with regard to occupational
and nonoccupational activities causing such conditions?
Answer. The panel has considered the contributions of occupational
and nonoccupational activities to the development of musculoskeletal
disorders via independent literature reviews based in observational
epidemiology, biomechanics, and basic science. As noted in the chapter
on epidemiology, when studies meeting stringent quality criteria are
used, there are significant data to show that both low back and upper
extremity musculoskeletal disorders can be attributed to workplace
exposures. Across the epidemiologic studies, the review has shown both
consistency and strength of association. Concerns about whether the
associations might be spurious have been considered and reviewed.
Biological plausibility for the work-relatedness of these disorders has
been demonstrated in biomechanical and basic science studies, and
further evidence to build causal inferences has been demonstrated in
intervention studies that show reduction in occurrence of
musculoskeletal disorders following implementation of interventions.
The findings suggest strongly that there is an occupational component
to musculoskeletal disorders. Each set of studies has inherent
strengths and limitations that affect confidence in the conclusions; as
discussed in Chapter 3 (methodology), when the pattern of evidence is
considered across the various types of studies, complementary strengths
are demonstrated. These findings were considered collectively through
integration of the information across the relevant bodies of scientific
evidence. Based on this approach, the panel concludes, with a high
degree of confidence, that there is a strong relationship between
certain work tasks and the risk of musculoskeletal disorders.
Question. What is the relative contribution of any causal factors
identified in the literature to the development of such conditions in
(a) the general population, (b) specific industries, and (c) specific
occupational groups?
Anwer.
Individual Risk Factors
Because 80 percent of the American adult population works, it is
difficult to define a ``general population'' that is different from the
working population as a whole. The known risk factors for
musculoskeletal disorders include the following:
Age.--Advancing age is associated with more spinal complaints, hand
pain, and other upper extremity pain, e.g., shoulder pain. Beyond the
age of 60, these complaints increase more rapidly in women than men.
The explanation for spinal pain is probably the greater frequency of
osteoporosis in women than in men. The explanation for hand pain is
probably the greater prevalence of osteoarthritis affecting women.
However, other specific musculoskeletal syndromes do not show this
trend. For example, the mean age for symptomatic presentation of lumbar
disc herniation is 42 years; thereafter, there is a fairly rapid
decline in symptoms of that disorder.
Gender.--As noted above, there are gender differences in some
musculoskeletal disorders, most particularly spinal pain due to
osteoporosis, which is more commonly found in women than in men, and
hand pain due to osteoarthritis, for which there appears to be a
genetic determinant with increased incidence in daughters of affected
mothers.
Healthy lifestyles.--There is a general belief that the physically
fit are at lower risk for musculoskeletal disorders; there are few
studies, however, that have shown a scientific basis for that
assertion. There is evidence that reduced aerobic capacity is
associated with some musculoskeletal disorders, specifically low back
pain and, possibly, lumbar disc herniations are more common in
cigarette smokers. Obesity, defined as the top fifth quintile of
weight, is also associated with a greater risk of back pain. There
currently is little evidence that reduction of smoking or weight
reduction reduces the risk.
Other exposures.--Whole-body vibration from motor vehicles has been
associated with an increase in risk for low back pain and lumbar disc
herniation. There is also evidence that suboptimal body posture in the
seated position can increase back pain. Some evidence suggests that
altering vibrational exposure through seating and improved seating
designs to optimize body posture (i.e., reduce intradiscal pressure)
can be beneficial.
Other diseases.--There is a variety of specific diseases found in
the population that predispose to certain musculoskeletal disorders.
Among the more common are diabetes and hypothyroidism, both associated
with carpal tunnel syndrome.
Work-Related Risk Factors
Chapter 4 of this report explores the enormous body of peer-
reviewed data on epidemiologic studies relevant to this question.
Detailed reviews were conducted of those studies judged to be of the
highest quality based on the panel's screening criteria (presented in
the introduction and in Chapter 4). The vast majority of these studies
have been performed on populations of workers in particular industries
in which workers exposed to various biomechanical factors were compared
with those not exposed for evidence of symptoms, signs, laboratory
abnormalities, or clinical diagnoses of musculoskeletal disorders. A
small number of studies have been performed in sample groups in the
general population, comparing individuals who report various exposures
with those who do not.
The principal findings with regard to the roles of work and
physical risk factors are:
--Lifting, bending and twisting and whole-body vibration have been
consistently associated with excess risk for low back
disorders, with relative risks of 1.2 to 9.0 compared with
workers in the same industries without these factors.
--Awkward static postures and frequent repetitive movements have been
less consistently associated with excess risk. For disorders of
the upper extremity, vibration, force, and repetition have been
most strongly and consistently associated with relative risks
ranging from 2.3 to 84.5.
The principal findings with regard to the roles of work and
psychosocial risk factors are:
--High job demand, low job satisfaction, monotony, low social
support, and high perceived stress are important predictors of
low back musculoskeletal disorders.
--High job demand and low decision latitude are the most consistent
of these factors associated with increased risk for
musculoskeletal disorders of the upper extremities.
--In addition, in well-studied workforces, there is evidence that
individual psychological factors may also predispose to risk,
including anxiety and depression, psychological distress, and
certain coping styles. Relative risks for these factors have
been generally less than 2.0.
Question. What is the incidence of such conditions in (a) the
general population, (b) specific industries, and (c) specific
occupational groups?
Answer. There are no comprehensive national data sources capturing
medically defined musculoskeletal disorders, and data available
regarding them are based on individual self-reports in surveys.
Explicitly, these reports include work as well as nonwork-related
musculoskeletal disorders without distinction; therefore, rates derived
from these general population sources cannot be considered in any sense
equivalent to rates for background, reference, or unexposed groups, nor
conversely, as rates for musculoskeletal disorders associated with any
specific work or activity. There are no comprehensive data available on
occupationally unexposed groups and, given the proportion of adults now
in the active U.S. workforce, any such nonemployed group would be
unrepresentative of the general adult population. According the 1997
report from the National Arthritis Data Workgroup (Lawrence, 1998), a
working group of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases, 37.9 million Americans, or 15
percent of the entire U.S. population, suffered from one or more
chronic musculoskeletal disorders in 1990 (these data cover all
musculoskeletal disorders). Moreover, given the increase in disease
rates and the projected demographic shifts, they estimate a rate of
18.4 percent or 59.4 million by the year 2020. In summary, data from
the general population of workers and nonworkers together suggest that
the musculoskeletal disorders problem is a major source of short- and
long-term disability, with economic losses in the range of 1 percent of
gross domestic product. A substantial portion of these are disorders of
the low back and upper extremities.
The Bureau of Labor Statistics (BLS) data, while suffering a number
of limitations, are sufficient to confirm that the magnitude of work-
related musculoskeletal disorders is very large and that rates differ
substantially among industries and occupations, consistent with the
assumption that work-related risks are important predictors of
musculoskeletal disorders. BLS recently estimated 846,000 lost-workday
cases of musculoskeletal disorders in private industry. Manufacturing
was responsible for 22 percent of sprains/strains, carpal tunnel
syndrome, or tendinitis, while the service industry accounted for 26
percent. Examining carpal tunnel syndrome alone, manufacturing,
transportation, and finance all exceeded the national average, while
for the most common but less specific sprains and strains, the
transportation sector was highest, with construction, mining,
agriculture, and wholesale trade all higher than average. These data
suggest that musculoskeletal disorders are a problem in several
industrial sectors, that is, the problems are not limited to the
traditional heavy labor environments represented by agriculture,
mining, and manufacturing.
The National Center for Health Statistics (NCHS) survey data
provide added information on self-reported health conditions of the
back and the hand. This survey presents estimates for back pain among
those whose pain occurred at work (approximately 11.7 million) and for
those who specifically reported that their pain was work-related back
pain (5.6 million).
The highest-risk occupations among men were construction laborers,
carpenters, and industrial truck and tractor equipment operators, and
among women the highest-risk occupations were nursing aides/orderlies/
attendants, licensed practical nurses, maids, and janitor/cleaners.
Other high-risk occupations were hairdressers and automobile mechanics,
often employed in small businesses or self-employed.
Among men, the highest-risk industries were lumber and building
material retailing, crude petroleum and natural gas extraction, and
sawmills/planing mills/millwork. Among women, the highest-risk
industries were nursing and personal care facilities, beauty shops, and
motor vehicle equipment manufacturing.
Questions from the NCHS survey on upper-extremity discomfort
elicited information about carpal tunnel syndrome, tendinitis and
related syndromes, and arthritis. Carpal tunnel syndrome was reported
by 1.87 million people; over one-third of these were diagnosed as
carpal tunnel syndrome by a health care provider and half were believed
to be work-related. Tendinitis was reported by 588,00 people, and 28
percent of these were determined to be work-related by a health care
provider. Over 2 million active or recent workers were estimated to
have hand/wrist arthritis. The survey did not report these conditions
by either occupation or industry.
Question. Does the literature reveal any specific guidance to
prevent the development of such conditions in (a) the general
population, (b) specific industries, and (c) specific occupational
groups?
Answer.
Development and Prevention in Working Populations
Because the majority of the U.S. population works, the data for the
population as a whole apply to the 80 percent who are working. There is
substantial evidence that psychosocial factors, in addition to the
physical factors cited above (see response to Question 4), are
significant contributors to musculoskeletal disorders. Relevant factors
are repetitive, boring jobs, a high degree of perceived psychosocial
stress, and suboptimal relationships between worker and supervisor.
The weight and pattern of both the scientific evidence and the very
practical quality improvement data support the conclusion that primary
and secondary prevention interventions to reduce the incidence,
severity, and consequences of musculoskeletal injuries in the workplace
are effective when properly implemented. The evidence suggests that the
most effective strategies involve a combined approach that takes into
account the complex interplay between physical stressors and the
policies and procedures of industries.
The complexity of musculoskeletal disorders in the workplace
requires a variety of strategies that may involve the worker, the
workforce, and management. These strategies fall within the categories
of engineering controls, administrative controls, and worker-focused
modifiers. The literature shows that no single strategy is or will be
effective for all types of industry; interventions are best tailored to
the individual situation. However, there are some program elements that
consistently recur in successful programs:
1. Interventions must mediate physical stressors, largely through
the application of ergonomic principles.
2. Employee involvement is essential to successful implementation.
3. Employer commitment, demonstrated by an integrated program and
supported by best practices review, is important for success.
Although generic guidelines have been developed and successfully
applied in intervention programs, no single specific design,
restriction, or practice for universal application is supported by the
existing scientific literature. Because of limitations in the
scientific literature, a comprehensive and systematic research program
is needed to further clarify and distinguish the features that make
interventions effective for specific musculoskeletal disorders.
Development and Prevention in Specific Occupations
Occupations that involve repetitive lifting, e.g., warehouse work,
construction, and pipe fitting, particularly when that activity
involves twisting postures, are associated with an increased risk for
the complaint of low back pain and, in a few studies, an increased risk
for lumbar disc herniation.
The prevalence of osteoarthritic changes in the lumbar spine (disc
space narrowing and spinal osteophytes) is significantly greater in
those whose occupations require heavy and repetitive lifting compared
with age-matched controls whose occupations are more sedentary. Despite
these radiographical differences, most of the studies show little or no
difference in the prevalence of low back pain or sciatica between those
with radiological changes of osteoarthritis and those with no
radiological changes. Based on the current evidence, modification of
the lifting can reduce symptoms and complaints. Specific successful
strategies, which include ergonomic interventions (such as the use of
lift tables and other devices and matching the worker's capacity to the
lifting tasks), administrative controls (such as job rotation), and
team lifting, appear successful. Despite enthusiasm for their use,
there is marginal or conflicting evidence about lifting belts and
educational programs in reducing low back pain in the population with
heavy lifting requirements. Some examples of positive interventions
include:
Truck drivers.--Vibration exposure is thought to be the dominant
cause for the increased risk for low back pain and lumbar disc
herniation. There are some data to support the efficacy of vibrational
dampening seating devices.
Hand-held tool operators.--Occupations that involve the use of
hand-held tools, particularly those with vibration, are associated with
the general complaints of hand pain, a greater risk of carpal tunnel
syndrome, and some tenosynovitis. Redesign of tools is associated with
reduced risks.
Food processing.--Food processing, e.g., meat cutting, is
associated with a greater risk of shoulder and elbow complaints. Job
redesign appears to reduce this risk, but this information is largely
based on best practices and case reports.
Question. What scientific questions remain unanswered, and may
require further research, to determine which occupational activities in
which specific industries cause or contribute to work-related
musculoskeletal disorders?
Answer. The panel's recommended research agenda is provided in
Chapter 12 of the report.
Appendix C.--Panel Response to Dissent
Dr. Szabo's dissent focuses on whether the panel was consistent in
evaluating the literature relevant to this report. His dissent deals
almost exclusively with only one of the musculoskeletal disorders
considered in the report; specifically he ascribes to the panel
overstatements about the research findings relating carpal tunnel
syndrome to work exposures of a variety of types.
Dr. Szabo states correctly that criteria for the inclusion of
studies in the report differed for the analysis of biomechanical
exposures and for the analysis of epidemiologic associations. The four
bodies of literature reviewed-tissue mechanobiology, biomechanics,
epidemiology, and workplace interventions-have differing study designs,
measurement techniques, and outcome variables. The selection criteria
used in determining the quality of particular studies necessarily
varied among these literatures (see Chapter 1, pp. 22). These criteria
were set early in the panel's deliberations. Specifically, the
biomechanics papers required detailed measures of biomechanical
exposure, while the epidemiologic studies did not require that same
kind of detail. Similarly, the epidemiologic papers had to meet
criteria for epidemiologic inference that were not required of the
biomechanics papers. The panel discussed the distinction carefully
before agreeing to adopt it. The distinction would be problematic only
if the panel made epidemiologic inferences from studies included in the
biomechanics section that failed to meet criteria for epidemiologic
studies. We did not do that.
Dr. Szabo contends that the panel concluded that interventions
examined in this study prevented carpal tunnel syndrome; this misstates
our report, which clearly states otherwise (see Chapter 8, pp. 313).
The report states that interventions influenced pain reports and not
the occurrence of specifically defined disorders of the upper
extremities. The studies are summarized in Table 8.3. The report does
not state that interventions prevent carpal tunnel syndrome or, indeed,
any other upper-extremity disorder. The emphasis, rather, is on
amelioration of symptoms, which is the end point in the relevant
literature. Furthermore, the comments on upper extremity interventions
carefully state that interventions influence symptoms, not the
incidence of specific disorders (Chapter 8, p. 313):
``Studies of engineering interventions for computer-related work
that reduce static postural loads, sustained posture extremes, and
rapid motions have demonstrated decreases in upper extremity pain
reports. Further study of these interventions is needed to determine
the amount of pain reduction possible, the duration of salutary effect,
and which upper extremity clinical conditions could benefit from these
interventions.''
Dr. Szabo uses the case of carpal tunnel syndrome with regard to
low-force, high-repetition exposures (primarily the use of computer
keyboards) as the causal factor to suggest that the relationship of
musculoskeletal disorders to work exposure may not be sound. The panel
has recognized that the evidence for low-force, high-repetition
exposures is weaker than for other relationships among risk factors and
musculoskeletal outcomes; however, strong evidence for causal
relationships between physical work and musculoskeletal disorders is
provided throughout the report.
The epidemiology section as it relates to the upper extremity was
carefully written. We discuss the cross-sectional designs of most
studies and possible implications for causal inference, including the
potential for the ``healthy worker'' effect. In 9 studies, carpal
tunnel syndrome was defined by a combination of a history of symptoms
and physical examination or nerve conduction testing. In these studies
there were 18 estimates of risk based on various specificities of
carpal tunnel syndrome diagnosis and varying degrees of work exposure.
Of these, 12 showed significant odds ratios greater than 2.0 (range 2.3
to 39.8), 4 showed nonsignificant odds ratios of greater than 2.0 and 2
showed nonsignificant odds ratios of between 1.7 and 2.0. The
epidemiology section, however, does not draw specific conclusions
regarding carpal tunnel syndrome. The report points out that just three
articles dealt with keyboard work; indeed, keyboard work is not a major
consideration or focus in the report.
Dr. Szabo's dissent provides an incomplete view of a study
published in the ``Journal of the American Medical Association''
(Atroshi, 1999). He states: ``In the general population the prevalence
of Carpal Tunnel Syndrome is the same whether people perform repetitive
activities or not.'' In the panel's view, the nature of the design in
that study and its survey instruments were such that the power to
demonstrate this association was not high. The study, however, did show
a significant risk for carpal tunnel syndrome for blue-collar work, use
of excessive force of the hands, working with excessively flexed or
extended wrist, or the use of hand-held vibratory tools; these findings
are not mentioned by Dr. Szabo.
Dr. Szabo cites the paper of Greenland and Robins (1988) to suggest
that without knowledge of cofactors which contribute to carpal tunnel
syndrome, ``estimates offered by Hagberg as well as the ones used in
the NAS report must be interpreted with caution.'' In fact, the thrust
of the Greenland and Robins argument is that such attributable risk
calculations may severely underestimate (not overestimate, as implied
by Dr. Szabo) the proportion of cases in which the etiologic factor is
important because of possible interactions between that factor and the
cofactors. Greenland and Robins cite numerous examples in which a small
excess risk masks a much larger effect of a primary study factor.
Several articles cited by Dr. Szabo in his discussion of the
epidemiology literature on carpal tunnel syndrome did not meet the
quality criteria (insufficient participation and inadequate exposure
measures were common problems) used by the panel in selecting articles
for the epidemiology review and so are not included in the report.
In his dissent, Dr. Szabo states, ``More importantly, reliance on
ergonomics to the exclusion of medical and health risk factors can have
adverse consequences for the patient.'' Nowhere in its report does the
panel suggest the exclusive use of ergonomic interventions.
It is important to reemphasize the fact that we made a major effort
to base our conclusions on literature that met accepted scientific
criteria and that the report represents consensus of all of the panel
members except for Dr. Szabo. At the same time, the report makes plain
the panel's view that the literature about musculoskeletal disorders is
incomplete, as all clinical and scientific literatures are, and also
emphasizes the importance of continuing research on a variety of
fronts. There is, however, sufficient basis in the research to date to
support our conclusions and recommendations.
Jeremiah A. Barondess, Chair
Mark R. Cullen
Barbara de Lateur
Richard A. Deyo
Sue K. Donaldson
Colin G. Drury
Michael Feuerstein
Baruch Fischhoff
John W. Frymoyer
Jeffrey N. Katz
Kurt Kroenke
Jeffrey C. Lotz
Susan E. Mackinnon
William S. Marras
Robert G. Radwin
David Rempel
David Vlahov
David H. Wegman
Senator Specter. Thank you very much. Dr. Jane Derebery,
occupational physician, Concentra Medical Services.
STATEMENT OF DR. JANE DEREBERY, VICE PRESIDENT OF
MEDICAL AFFAIRS, CONCENTRA MEDICAL SERVICES
Dr. Derebery. Thank you, Mr. Chairman. I am an occupational
medicine physician. I serve as the vice president of Medical
Affairs of Concentra Health Services which is the largest
occupational health group in the country. We treat over 500,000
injured workers each year.
I am neither an academician nor a researcher, and had not
met Drs. Bigos, Hadler and Burton prior to this, but know them
very well through their work, which has aided me in my own
practice for many, many years. It also aids me in physician
training with my company.
In my early training in occupational medicine, of all the
courses I took I was most excited by the ergonomic courses. It
made logical sense to me that repetitive, awkward and forceful
activities of my patients could potentially cause them
problems. And it also made sense to apply the principles of
ergonomics as a solution.
However, once I got into private practice, I quickly saw
that there was no consistency between the amount and type of
activities that my patients were performing and whether or not
they developed musculoskeletal problems.
Those ailments that are believed to be caused by repetitive
motion such as tendonitis and carpal tunnel can and do occur
with no provocation, no known cause; are also associated and
even caused by many, many medical conditions.
What in actual practice the ergonomics standards simply do
not help me with those patients. Instead, I found that dealing
with external factors such as underlying medical conditions or
health problems and psychosocial stressors coupled with the
sports medicine approach seemed to be more effective.
In my concern about the ergonomic standard as it was
proposed, was that it is asking me as a physician to treat my
patients as if the primary and only cause of their complaint
was due to their physical activities at work. To wrongly
classify something as work-related not only increases
disability likelihood, it misdirects medical care, and it can
inappropriately exclude a patient from a job. In addition, it
is an unnecessary drain to the workers' comp system.
At my company we have the largest clinical outcome database
in the country. And that has facilitated our ability to study
and improve our outcomes. In an analysis of work-related,
nontraumatic musculoskeletal disorders, we have demonstrated
that the treatment strategy when it is focused predominantly on
patient issues rather than the physical job factors, that we
get substantially improved outcomes.
In one regional analysis, the physicians were given
training that promoted demedicalization and early activation in
patients that had musculoskeletal problems. And in most of the
cases the patients were kept at full duty during treatment.
In the treatment, the extraneous contributing health
problems and psychosocial stressors were investigated for, and
when appropriate, addressed. A conditioning exercise program as
well as stress management principles generally predominated as
treatment recommendations. While appropriate job problem-
solving and ergonomics suggestions were given, they were very
seldom a primary part of our treatment.
And what we found was the clinical outcomes comparing this
treatment strategy with other regional providers substantially
reduced the lost time, restricted duty, disability and cost
with no increase in recurrences and with high patient
satisfaction.
We found similar findings with our low back pain change
strategy and in which our physicians were encouraged to adhere
to the evidence-based treatment guidelines such as those of the
Agency for Health Care Policy Research in the United Kingdom.
And once again, we found with those patients the majority
were kept at full duty. And with that strategy, we had a
substantial improvement over those patients who were treated
the traditional way.
The cause of musculoskeletal disorders are multifactorial
involving as many psychosocial and medical and health
conditions as physical. And my concern as a physician is if we
focus on the physical and the ergonomics, it may result in
increased morbidity and in disability for my patients and at
great cost to industry as well.
prepared statement
Dr. Evanoff in the last panel mentioned the American
College of Occupational Medicine Guidelines in his endorsement
of the ergonomics standard. I am a fellow of the American
College of Occupational Environmental Medicine. And for the
record, we did not come out, we did not endorse the ergonomic
standards for the same reason that I did not. Thank you.
[The statement follows:]
Prepared Statement of Dr. Jane Derebery
I am Dr. Jane Derebery, a board certified occupational medicine
physician and the vice president of medical operations for the Southern
Region of Concentra Health Services, the largest occupational medicine
group in the United States. Each year over five million patients are
seen at our clinics, and 500,000 new patients with work-related
injuries are treated.
I am neither an academician nor a researcher, but rather a
practicing clinician within the private sector. Although I had not met
Drs. Bigos, Hadler and Burton previously, I know them through their
work and publications, which have aided me in my own practice as well
as in physician training. Their work is especially appreciated, as
there are widespread misinformation, half-truths, and even myths on the
subject in both medical and lay literature.
Since the advent of OSHA in 1970, work places have become safer,
material handling reduced, and improved ergonomics implemented in many
industries--yet low back disability has continued to escalate, as have
complaints of musculoskeletal pain in general. This trend would support
what the few high quality studies performed have demonstated: there is
not evidence that ergonomic job design will prevent musculoskeletal
disorders and pain.
When I first began in occupational medicine in the eighties, I
found that the ergonomics courses were the most exciting ones that I
took. It made logical sense that the more a worker was exposed to
repetitive, awkward or forceful activity, the more likely he was to
incur injury. Learning and applying principles of ergonomics seemed
like the logical solution for my patients.
Once I was in actual clinical practice, however, I quickly
discovered that there appeared to be little consistency regarding
amount and type of activity of patients and whether or not they
developed musculoskeletal problems. The principles of ergonomics that I
had been taught didn't seem to aid me in the real world, particularly
with my more difficult patients--instead, identifying external
contributors such as underlying medical conditions and psychosocial
stressors, and using a sports medicine approach seemed to be more
effective.
There are inherent risks in allowing politics and public policy
rather than science to decide what causes disease. Musculoskeletal
aches and pains are common among all of us regardless of our work and
leisure activities. Many ailments attributed to repetitive, forceful or
awkward activity can and do occur with no identifiable provoking cause
and can also be caused by systemic medical conditions. In the workers
compensation arena, physicians are being asked to treat muscloskeletal
pain as if the predominant and only cause is the physical aspect of
work. Musculoskeletal disorders generally are multifactoral in origin,
just as are many other medical maladies such as heart disease or
headaches. To wrongly classify a musculoskeletal illness as work-
related increases the likelihood of disability developing, misdirects
medical care, can inappropriately exclude an individual from his
regular job, and places an unnecessary drain on the workers
compensation system.
Concentra has the largest clinical outcome database of any medical
organization in the country, and having outcome data has greatly
facilitated our ability to study and improve clinical outcomes.
Analysis of Concentra outcome data has indicated that when dealing with
nontraumatic musculoskeletal disorders, a treatment strategy focusing
predominantly on patient issues rather than physical job factors
results in substantially improved outcomes.
In one Concentra study, seven physicians in Austin were given
training that promoted keeping most patients with upper extremity non-
traumatic complaints at their regular jobs during treatment, under the
presumption that since the job had caused no problems for the worker
previously, it was likely that non-work factors were predominant causes
of the symptoms.
The physicians are advised to give the patient reassurance that the
problem isn't serious, and to prescribe an appropriate program to
increase strength, flexibility and endurance. Stress reduction
techniques such as regular aerobic exercise, relaxation, etc. are also
prescribed. Extraneous contributions such as underlying health problems
and psychosocial stressors are investigated and when necessary
addressed. While appropriate job problem solving and ergonomic
suggestions are made, these are usually not a primary focus of the
treatment.
The clinical outcomes of these providers have been followed and
compared to 92 other providers in other cities in the southern region.
The change in treatment strategy have resulted in substantial,
statistically significant improvements in cost of care and disability
with no reduction in patient satisfaction. Interestingly, as physicians
have experienced good outcomes among their patients, they have
gradually become even more assertive in their management of patients,
as evidenced by continued improvement from 1997 through 2000.
Between 1997 and 1999, the seven providers had reduced their
percentage of patients on restricted duty from 74 percent to 30 percent
for an average of 22 days, as compared to the other 92 providers, who
placed 82 percent on restricted duty for 26 days. In addition, in 1999,
the 367 Austin patients had no lost time, compared to a lost time rate
of 3 percent in other cities. Only 6.5 percent of the Austin patients
required specialty referral, compared to 21 percent by the other
cities' providers. The cost of care in Austin dropped substantially
because the patients required fewer physical therapy visits and doctor
visits, with the average cost in Austin being $730 per case compared to
$959 per case among the other providers.
We have also had similar findings regarding low back pain by
encouraging our physicians to adhere to evidence-based low back pain
treatment guidelines such as those from the Agency for Health Care
Policy and Research and from the United Kingdom. Specifically, the
guidelines encourage maintenance or resumption of normal activity,
including work, in patients with low back pain. The physicians
achieving the best outcomes typically and consistently place only 15-35
percent of their back pain patients on restricted duty during the
treatment course, compared to an overall national average approaching
90 percent.
There are strong cultural beliefs and influences that play
predominant roles in shaping expectations about the ability of
repetitive physical activity to cause musculoskeletal disorders. This
has rendered us susceptible to the misinformation and myths being
widely published not only in the lay literature but even in the medical
literature.
For example, there is no scientific evidence to support that carpal
tunnel syndrome can be caused or aggravated by prolonged keyboard use;
yet I have repeatedly seen that reported as fact in such widely read
periodicals as TIME, Newsweek, and the New York Times. Two years ago,
when a hand surgeon from Columbia University testified as an expert
witness in a products liability class action suit against a keyboard
manufacturer, he rendered his medical opinion that keyboarding caused
the claimants' carpal tunnel syndrome. When pressed to cite what
scientific article he had read to justify his opinion, he finally
stated that he had read it in TIME magazine! In actuality in the almost
fifty cases of products liability suits against keyboard manufacturers
not one claimant has ever been awarded a cent, so strong is the
scientific evidence that use of a keyboard does not cause carpal tunnel
syndrome. Yet, the myth that it does prevails in our society--with
profound influence.
The cause of the current spate of CTD disorders is multifactoral,
involving as many psychosocial and medical factors as job-related ones.
To focus exclusively on the physical and ergonomic aspects of the
problem may result in increased morbidity and disability at great cost
to the patient and to society. Addressing the problem as it is
perceived by the patient or the public, contributes to the problem
rather than to its resolution.
Senator Specter. Thank you very much, Dr. Derebery. We now
turn to Dr. Laura Punnett.
STATEMENT OF DR. LAURA PUNNETT, PROFESSOR, DEPARTMENT
OF WORK ENVIRONMENT, UNIVERSITY OF
MASSACHUSETTS
LOWELL
Dr. Punnett. Thank you very much, Senator. I think perhaps
there are a few things that almost everyone in this room could
agree upon. One is that some musculoskeletal disorders are not
work-related. Some I think the rest we may be in disagreement
about, but certainly there is an important amount of morbidity
which arises in relation to non-occupational factors is really
not in dispute by anyone.
Another important point is that some amount of physical
activity is essential to maintaining good health. And the key
question then for us is how much activity or effort or motion
is too much. And I would add what kind and under what
conditions.
People who are employed full-time spend----
Senator Specter. So where there is agreement is that some
ailments are not related to work and some exercise is good?
Dr. Punnett. Yes, Senator.
Senator Specter. And that is where you stop your testimony
on the area of agreement?
Dr. Punnett. Correct. I am not sure I am going to be able
to offer you much more----
Senator Specter. That is not a whole lot of agreement, Dr.
Punnett, but it is not inaccurate from what I have heard. Go
ahead.
Dr. Punnett. I am trying to help you find some consensus.
Senator Specter. Trying to help me find what?
Dr. Punnett. Some consensus.
Senator Specter. I would not call it consensus to say that
it is 11:15, which is about what you have said. Go ahead.
Dr. Punnett. People who are employed full-time spend more
waking hours at our jobs than anywhere else. But I think of
equal importance to the hours we spend at work is that while we
are at work we do not have the same freedom to choose how we
spend our time as we do for example when we are gardening or
playing tennis.
A stenographer in a courtroom has to keep up with an expert
witness who is giving testimony. A mail carrier has to complete
a route and return to the post office within a specified period
of time.
A nurse's aid has to move a disabled patient from the
wheelchair to the commode when the patient's needs dictate,
even if there is no one else nearby to help.
So the way the work is organized, the tasks designated to
each individual, the equipment or tools provided determine both
the physical load, how fast you are working, how hard, what
body postures are necessary, as well as what we call the
psychosocial factors, meaning psychological demands such as
time pressure, opportunity to decide what to do when, factors
that are generally under the employer's control as well as the
physical load factors are.
These psychosocial factors are established to be associated
with the subjective experience of stress. They are related to
risks of some diseases such as cardiovascular disorders.
The scientific literature on their effect on
musculoskeletal disorders is quite more recent and still very
limited, while in contrast the literature on physical factors
is voluminous.
And we have already heard from the NAS that there are
literally hundreds of studies with a variety of study designs
and methods, different samples of the population conducted in
many different countries all showing risk of musculoskeletal
disorders to be proportionate to the level of exposure to
physical load.
These kinds of exposure response examples are numerous.
Just two very quick examples, a German study showing that new
back pain among male construction workers was associated with
the amount of handling of concrete blocks and other heavy
paving items, and a British study of nurses showing that the
incidence of new back pain was proportionate to the number of
patients handled per day.
So the literature is voluminous. There have been dozens of
reviews of this literature as well. Like both of the NAS
reports, virtually all of the reviews, not all but the vast
majority, agree that some studies are better than others, that
not every question has been answered yet but that there is a
very substantial evidence showing the relationship of physical
workload to musculoskeletal disorders.
The better studies include a variety of, meet a variety of
scientific and methodologic criteria including the fact that
they address the role of non-occupational factors. If someone
has a history of a wrist injury or goes bowling every Thursday
night or has been diagnosed with diabetes, we have statistical
methods of removing the influence of these individual factors
and making sure that or evaluating whether the association is
still there when they are taken out of the picture.
If we limit ourselves to the cream of the crop, the few
dozen studies rather than the few hundred which are most
rigorous, we still have at least ten times as many studies as
OSHA had to rely on in rule making on benzine for example or
setting a permissible exposure limit for lead in air or rule
making on formaldehyde.
prepared statement
Of course not every question has been answered, but again
standards have been passed without every ``I'' being dotted and
every ``T'' crossed. We had no animal model for asbestos or for
benzine effects at the time that those OSHA standards were
passed. And I respectfully submit that while we need more
research, we also have ample evidence in hand now to begin to
prevent the many unnecessary disorders that are occurring.
[The statement follows:]
Prepared Statement of Dr. Laura Punnett
Qualifications and experience
I am an occupational epidemiologist and ergonomist with a Doctor of
Science degree in epidemiology and occupational health and safety from
the Harvard School of Public Health and two years of specialized post-
doctoral training in occupational ergonomics at the Center for
Ergonomics, The University of Michigan (Ann Arbor). I am a founding
faculty member of the Department of Work Environment at the University
of Massachusetts Lowell (UML), where I now hold the rank of Professor.
The Department combines a traditional occupational health and safety
approach to the identification of workplace hazards with a more
innovative focus on the development and evaluation of engineering
control measures for those hazards. I am also Co-Director of the Lorin
Kerr Ergonomics Institute for Occupational Injury Prevention at UML.
The Institute conducts research and provides technical assistance
throughout the region on the health, safety, and productivity
consequences of the failure to design jobs to fit human needs. We take
a multi-disciplinary approach to the study of work-related
musculoskeletal disorders, injuries and psychosocial stress, their
impact on employers, workers, and society, and their prevention through
changes in work organization and equipment.
My primary research areas are the epidemiology of work-related
musculoskeletal disorders; the effect of ergonomic stressors on other
health endpoints, such as pregnancy outcomes and acute injury; and
methods for workplace measurement of ergonomic exposures, including the
validity of worker self-assessments. Since 1981, I have investigated
these issues in a wide variety of manufacturing and service
occupations, including the automobile industry, garment assembly and
other light manufacturing, clerical work, retail food stores,
hospitals, small farms, sawmills and wood products processing, and
highway construction. I have also studied the factors influencing the
effectiveness of ergonomic intervention programs and joint labor-
management health and safety committees in industry. I am the author or
co-author of about 40 articles in peer-reviewed scientific journals, as
well as numerous book chapters, technical reports, and papers and
abstracts in peer-reviewed conference proceedings. My research has been
funded by the National Institute for Occupational Safety and Health
(NIOSH), the Centers for Disease Control Center on Injury Prevention,
the UAW-Chrysler Joint National Committee on Health and Safety, the
March of Dimes, and the Massachusetts Centers of Excellence
Corporation.
Since 1993 I have been a Visiting Lecturer in Occupational Health
at the Harvard School of Public Health, in Boston. I am a member of the
Research Committee on Musculoskeletal Disorders of the International
Commission on Occupational Health. In 1996, I was in residence as a
Visiting Scientist in the Division of Ergonomics, National Institute of
Working Life, Sweden; since that time I have had continuing
collaborations with several researchers at the Institute and have
returned for several working visits. I have served by invitation on the
NIOSH Mine Health Research Advisory Committee (U.S. DHHS), two NIOSH
research review panels, and advisory boards for the Massachusetts
Department of Public Health Occupational Disease Surveillance (SENSOR)
Project, the Center for VDT and Health Research, Johns Hopkins School
of Hygiene and Public Health, the Occupational and Industrial
Orthopedics Center (Hospital for Joint Diseases, New York NY), and the
Ergonomics Technology Center of the University of Connecticut
(Farmington CT). I have consulted on environmental and occupational
epidemiology to the World Health Organization. I serve on the Editorial
Boards of the peer-reviewed journals, Applied Ergonomics, New
Solutions: A Journal of Environmental and Occupational Health Policy,
and Salud de los Trabajadores (``Workers' Health,'' published in
Venezuela). I have served as a peer reviewer to 12 scientific journals
and several private and public research funding agencies.
Both as an individual consultant and through the Kerr Ergonomics
Institute, I have conducted training programs in occupational
ergonomics for engineers, supervisors, medical and safety personnel,
and labor representatives in a wide variety of workplaces. Consulting
clients have included General Motors, Ford Motor Company, Digital
Equipment Corporation, General Electric, Millipore, Herman Miller, Jim
Walters Paper, CBS/Fox Video, and the U.S. Army Environmental Hygiene
Agency. I have lectured internationally on occupational health,
ergonomics and epidemiology and presented seminars and professional
short courses for professional associations (e.g., American Industrial
Hygiene Association, American Society of Safety Engineers, Nordic
Institute for Advanced Training in Occupational Health and Safety,
International Commission on Occupational Health, Israeli Ergonomics
Society) as well as at institutions of higher education in the United
States, Canada, The Netherlands, Spain, Chile, and Sweden.
In 1998, I was invited to participate on the panel that reviewed
the epidemiologic evidence on work-related musculoskeletal disorders
for the National Academy of Sciences (National Research Council), in
response to a mandate from the U.S. Congress. In 1999, I was a member
of the committee that drafted the new Threshold Limit Values (TLVsR) on
Hand Activity Level of the American Conference of Governmental
Industrial Hygienists--a set of quantitative exposure limits intended
to aid in preventing or reducing the occurrence of upper extremity
musculoskeletal disorders.
Issues addressed in this testimony
This testimony primarily addresses the epidemiologic literature on
work-related MSDs, including the basis for concluding that there is a
causal relationship with occupational physical ergonomic stressors and
that reductions in harm to workers can be anticipated by reductions in
exposure to these stressors. Exposure-response relationships have
repeatedly been demonstrated, and the evidence is at least
qualitatively consistent across sectors of the economy and around the
world, wherever the problem has come to light. There are unresolved
questions regarding the nature and role of psychosocial factors and
more research is needed to clarify diagnostic dilemmas and to elucidate
pathomechanisms. There is striking evidence that MSDs are greatly
under-reported in many workplaces and that therefore, however high the
frequency and costs of MSDs may seem, the true magnitude is undoubtedly
greater than statistics show. Although formal intervention studies are
difficult to conduct successfully, there is substantial experience of
the feasibility and benefits of workplace ergonomics interventions
(training and engineering controls) implemented by employers.
Scientific evidence regarding physical exposures and the occurrence of
MSDs
There is an extensive scientific literature documenting that
physical job features can cause musculoskeletal disorders. These
hazards can occur in a multitude of forms, depending on the specific
nature of the work; the characterization of ergonomics exposures thus
often depends on the sector of employment and even the specific
occupation. Nevertheless, a common set of occupational exposures has
been associated generically with adverse musculoskeletal health
effects.
The scientific evidence for the work-related occurrence of
musculoskeletal disorders among occupationally exposed individuals
includes both epidemiologic studies and basic science (biomechanical
and patho-physiological laboratory experiments). The combination of the
two is important because together they demonstrate the biological
plausibility of the epidemiology and the coherence and complementarity
of the findings. For example, tendon strain and cell damage have been
shown to occur experimentally as a function of work pace (the frequency
and duration of mechanical loading), the level of muscular effort, and
recovery time between exertions.
The basic science pertaining to mechanisms by which physical load,
in its various forms, can damage soft tissues was reviewed by Rempel et
al., Ashton-Miller, and Radwin and Lavender for the National Academy of
Sciences (NAS) in 1998 (1), as well as by others (e.g., 2-7). The
preamble to the OSHA Ergonomics Standard (Section V., ``Health
Effects'') also summarized the literature, illustrating how repeated or
forceful efforts, sustained static loading, anatomically non-neutral
postures, accelerated movements, externally applied compressive forces,
and vibration are understood to affect musculoskeletal, nerve, and
circulatory tissues.
niosh review of msd epidemiology in 1997
The authoritative review of the epidemiology in this field is that
published by the National Institute for Occupational Safety and Health
(NIOSH) in 1997 (8). This literature review was conducted according to
standard, accepted epidemiologic principles and gave greatest weight to
studies in which the results could be shown to be relatively unaffected
by selection bias or information bias. Almost all of the studies
considered in the review had been published in peer-reviewed scientific
journals, meaning that they already had been through the standard
quality control process and found to be scientifically valid prior to
their publication. The review document itself was evaluated prior to
publication by 27 scientists with research, teaching, and consulting
expertise in the field of occupational ergonomics.
The NIOSH review concluded that there is ``a consistent
relationship between MSDs and certain physical factors, especially at
higher exposure levels.'' Although some specific exposure-response
relationships have not been demonstrated and more research is needed in
several areas, there is evidence that exposure to each of these
ergonomic factors causes MSDs in one or more body regions: repetitive
upper extremity motion patterns; forceful exertions, whether manual
only or whole-body (e.g., heavy lifting); non-neutral body postures;
and vibration. The risk is especially pronounced when a job includes
exposure to a combination of two or more of these risk factors.
The odds of finding so many positive studies, using so many
variations on study design and methods, in so many countries, would be
extremely small if ergonomic exposures were not truly hazardous to the
musculoskeletal system. Even were we to restrict ourselves to the 13
investigations that were the most rigorous and convincing, these would
represent a larger body of evidence than has been used for OSHA rule-
making on many other workplace hazards.
These strongest studies also demonstrate that physical job factors
cause MSDs independently of any other factors, such as medical history,
age, or psychosocial strain, that might also be associated with MSDs in
the general population. In other words, while MSDs have a background
rate in the general population that is above zero, there is a marked
additional increase among people whose jobs expose them to excessive
physical demands.
epidemiologic evidence since 1997
In addition to those studies relied upon by NIOSH in the 1997
review, other investigations are continuously being carried out. The
studies published since 1997 are too numerous to catalogue them all
here; some notable examples have been selected to highlight the ever-
expanding knowledge base. These are chosen, in particular, to fill in
gaps that NIOSH identified with regard to particular exposure-response
combinations, and to illustrate how newer studies, many of them
longitudinal, are adding to the evidence confirming earlier conclusions
that were based primarily on cross-sectional studies. Longitudinal
investigations are particularly important because they are less
ambiguous with regard to cause preceding effect than other study
designs, so the resulting evidence is inherently stronger. In addition,
they can provide evidence regarding the progression (``natural
history'') of MSDs, the latency period from exposure to effect, and the
factors affecting prognosis or outcomes after MSD onset.
For example, the NIOSH review concluded that there was
``evidence,'' but not ``strong evidence,'' that postural stress and
repetitive work cause shoulder disorders, and ``insufficient evidence''
to draw conclusions about the effects of forceful work or vibration on
the shoulder. More recently, at least two new studies have provided new
evidence regarding the effects of these exposures on the shoulder.
Frost and Andersen (9) followed a closed cohort of 1,591 workers from a
slaughterhouse and a chemical factory over a seven-year period. The
slaughtering and meat processing tasks were videotaped and analyzed in
detail and shown to involve pronounced postural stress, with the upper
arms elevated to an included angle of 30 degrees or more for about one-
half of the work day. Shoulder impingement syndrome, defined as a
combination of shoulder symptoms lasting at least 3 months within the
past year plus a positive sign of impingement on clinical examination,
was more common among slaughterhouse workers than among the chemical
workers. The risk increased with number of years of exposure to meat
processing work and was particularly high among former slaughterhouse
workers. The age-adjusted prevalence ratio showed a steep slope in the
first 5 to 6 years of exposure and then another steep increase after
about 25 years of cumulative exposure, providing evidence that risk
increases with duration of exposure to postural stress and heavy work,
even after many years of employment.
My colleagues and I conducted a case-control study of shoulder
disorders reported to the in-house medical department of an automobile
assembly plant (10). All cases and a random sample of non-case workers
from the same production departments were evaluated by interview and
physical examination. Shoulder disorders (on combination of medical
report and interview) were associated with severe flexion/abduction
(above 90 degrees) of the shoulder. The risk of incurring a shoulder
MSD increased with the proportion of the work cycle that workers were
exposed to severe flexion/abduction. The exposure-response
relationships were similar for cases with and without physical
findings. Forces exerted through the shoulder did not confound these
results; peak torques at the shoulder were rather low for all workers.
Use of hand-held tools further increased the risk and also interacted
with postural stress.
Relevant evidence regarding the effect of ergonomic exposures on
the neck is also found in a report on persistent neck disorders
associated with use of a now obsolete grinding machine in a Swedish
steelworks (11). Use of this machine had ``caused heavy static load to
the arms, shoulders, and neck, vigorous impacts and vibrational forces
being transmitted upwards via the out-stretched arms.'' The authors
located the last 15 workers who had performed this work, all of whom
had left the occupation 11-29 years earlier because of continuous neck-
shoulder pain, and 6 of whom were on total disability pension. Even
after so many years, all still had persistent neck pain, stiffness,
reduced range of motion, joint degeneration, widespread numbness and
tingling and reduced sensation.
A number of new studies have addressed the effects of repetitive
manual work on upper extremity disorders (12-15). Nordander et al. (16)
examined a set of fish processing jobs that were all highly repetitive,
with fast, restricted movements and only light lifting demands.
Compared with people with more varied jobs, the fish processing workers
had triple the risk of neck/shoulder and elbow/hand diagnoses by
physical examination. There were 5 cases each of wrist tendonitis and
carpal tunnel syndrome (CTS) among the fish processing workers,
compared with 0 and 1, respectively, in the other workers. Work
processes changes in another fish processing plant increased the
repetitiveness and stereotypy of the physical motion patterns, which
led to increased risk of elbow, wrist and finger symptoms (17). In a
study of CTS patients and prognosis after medical treatment, the
performance of hand-intensive work prior to onset was associated with
less complete relief of CTS symptoms after surgery, which in turn
predicted failure to return to work due to CTS (18). Thus, NIOSH's
findings of ``evidence,'' but not ``strong evidence,'' that repetitive
and forceful work cause CTS can also be updated from these more recent
findings.
A series of papers by Nathan and colleagues on median nerve
neuropathy (MNN), an indicator of CTS, has purported to show that the
only ``important'' causes are individual, non-occupational factors such
as age and obesity (e.g., 19-22). This on-going cohort study suffers
from a number of serious methodologic flaws, as noted by NIOSH (see
summary in Table 5a-5 of (8)) and others (23). However, it should also
be noted that the authors' ranking scheme for physical work demands
(repetition and force) was cross-sectionally associated with MNN (19)
and predicted the 5-year incidence of slowed nerve function (20). Other
reviewers of this paper have concurred in finding these data to show a
positive association (24). The question as posed by Nathan and
colleagues, whether occupational or non-occupational causes of CTS are
``more important,'' is misleading (and is not appropriately answered by
statistical testing such as p-values). Rather, the appropriate policy
question is whether, among persons exposed to ergonomic stressors at
work, an important proportion of CTS (and other disorders) could be
prevented by workplace improvements. The data published by Nathan et
al., in fact, support rather than argue against this conclusion.
With regard to back disorders, the NIOSH document also concluded
that there was evidence, but not strong evidence, regarding the effect
of ``heavy physical work'' on back disorders. Since then, a German
research group published a three-year prospective study of 571 male
construction workers, who participated in ``comprehensive interview and
physical examination surveys'' at baseline and again at follow-up (25).
The proportion of the population followed up was 86 percent, and only
exposure information shown to be reproducible was used in the analyses.
After adjustment for age, height, and body mass index, the risk of new
low back pain was increased among workers whose work tasks included
scaffolding, sawing, erecting roof structures and laying large
sandstones. After further adjustment for trade, to account for tasks
performed only by carpenters or bricklayers, for example, additional
exposure-response relationships were found for two different indices of
cumulative exposure to handling heavy stones or concrete blocks.
A prospective investigation of nurses in Great Britain (26) was
remarkable for the intensity of its follow-up procedures; the nurses
were asked to complete a standardized questionnaire every 3 months for
a two-year period. Among those who had been free from low back pain for
at least one month at baseline, the risk of new pain was predicted by
the frequency of manual transfer of nurses' patients under various
conditions. The authors noted, as have others previously, the
additional effect of prior back pain, which in itself may be a marker
for prior occupational loading on the back. Another recent study of
heavy work and back disorders involved a five-year follow-up of a
random sample from the general population in Finland (27), in which the
outcome was defined as moderate or severe back pain with functional
impairment. The study concluded that, ``heavy occupational
musculoskeletal loading and high general occupational physical demands
predicted future back pain.'' A six-year follow-up of dock workers
showed that very heavy work was associated with a higher rate of
increase in musculoskeletal disorders on examination of the back, neck,
shoulders, hands and feet (28).
Other cohort studies have examined the risk of disorders in the
musculoskeletal system overall. A Dutch study reported increased
frequency of musculoskeletal symptoms among male employees who
performed heavy physically demanding work, especially in the young and
middle-aged subjects (29). Long-term disability, especially that due to
musculoskeletal disorders, was predicted by the number of years worked
in piece-rate garment manufacturing in Canada (30). In a sample of the
French population after retirement, the cumulative incidence of
disorders of the back, upper or lower limb joints was higher among
those who had performed heavy physical work for longer than ten years
(31). Another recent study of my own found a strong cross-sectional
relationship between upper extremity disorders and combined ergonomic
exposures, with the same exposure index prospectively predicting both
the incidence of new disorders after one year and the persistence of
upper extremity problems from baseline (32, 33).
other literature reviews
Other epidemiologic reviews of workplace exposures and MSDs, by
experts in various countries, have been published in the peer-reviewed
scientific literature. Although they have varied somewhat in their
inclusion and exclusion criteria and review procedures, the majority of
these reviews have drawn similar conclusions regarding the causal
importance of repetitive motion, forceful manual exertions, non-neutral
postures, and segmental vibration for upper extremity disorders and of
heavy lifting, non-neutral trunk postures and whole-body vibration for
disorders of the back and lower limbs (2, 24, 34-60).
NIOSH's review and basis for these conclusions was itself
subsequently endorsed, both methodologically and substantively, by the
National Academy of Sciences in 1998. The first NAS study was publicly
discussed by about 75 scientists and other workshop participants, the
overwhelming majority of whom agreed that ``There is a higher incidence
of . . . injury . . . and disability among individuals who are employed
in occupations where there is a high level of exposure to physical
loading than for those employed in occupations with lower levels of
exposure'' (page 23 in (1)). (The second NAS study is not described
here because it will be discussed separately at this hearing.)
In 1997, the Swedish National Institute of Working Life (NIWL)
commissioned a review of the epidemiologic literature specifically
limited to occupational use of video display units (VDU) and upper
extremity musculoskeletal disorders. This review covered 72 reports
from 56 different epidemiologic studies, primarily peer-reviewed
scientific journal articles (61). The NIWL endorsed the conclusion that
use of a VDU was a direct causative agent of hand and wrist disorders,
mediated primarily through repetitive finger motion and sustained
muscle loading across the forearm and wrist. The risk was particularly
pronounced for those in more keyboard-intensive jobs, such as data
entry, which are more stereotyped and involve more continuous exposure
with fewer alternative tasks or rest breaks.
In 1999, Dr. Barbara Silverstein and I re-considered the
epidemiologic literature on work-related MSDs, at the request of the
American Conference of Governmental Industrial Hygienists (ACGIH), in
order to assess the nature of the guidance that could be obtained as a
basis for establishing one or more Threshold Limit Values
(TLV) for occupational exposure to physical ergonomic stressors (62).
From the most rigorous epidemiologic studies, we extracted data on
dose-response relationships and on exposure levels at which there was a
significant increase in risk of upper extremity MSDs and which could be
operationalized in the form of a TLV; for example, there was
quantitative evidence to justify a TLV of 1-2 hours per day of exposure
to repetitive wrist bending or twisting, 1 hour per day of highly
forceful manual work, and 1 hour per day of shoulder flexion or
abduction (work with the arm above shoulder height). Four different
studies showed an increased risk of shoulder disorders when such
postural stress is experienced for only 1 to 2 hours per day (see Table
6). We also confirmed the findings of Bernard et al. (8) that exposure
to multiple ergonomic risk factors in the same job has at least an
additive effect, if not much greater, and recommended that a TLV for
any one dimension of physical load should take account of whether other
forms of exposure are also present in the job. A new report by the
European Agency for Safety and Health at Work (63), an office of the
European Union, has concluded that, ``The scientific reports, using
defined criteria for causality, established a strong positive
relationship between the occurrence of some WRULDs [work-related neck
and upper limb musculoskeletal disorders] and the performance of work,
especially where workers were highly exposed to workplace risk
factors.'' The risk factors identified as particularly requiring
preventive reductions by the European Agency were a familiar list: non-
neutral postures of the shoulder and wrist, force applications at the
hand, hand-arm exposure to vibration, direct mechanical pressure on
body tissues, cold, and work organization factors.
exposure-response relationships
A large number of investigations have demonstrated exposure-
response relationships between physical ergonomic exposures and the
risk of MSDs, and a number of reviewers have cited this evidence in
concluding that there were causal relationships (e.g., 2, 8, 41, 43,
58, 64). An exposure-response relationship means, in general terms,
that as the amount (intensity, frequency or duration) of a risk factor
increases, so does the probability, or risk, of an adverse health
effect. An exposure-response relationship, when present, is considered
to strengthen the evidence of a causal relationship because it is
believed to be a characteristic of cause-effect situations, in general,
absent evidence to the contrary. In addition, it is thought that it
would be more difficult for many or most forms of bias or confounding
to produce an artifactual exposure-response relationship than to bias a
simple association such as an odds ratio.
Some have argued that the lack of comprehensive exposure-response
data represents a level of scientific ignorance that prohibits any
preventive action. However, it is not a sine qua non, in that an
epidemiologic study can provide valuable information even if both
exposure and outcome are dichotomous. Furthermore, the lack of an
exposure-response relationship is not necessarily evidence against a
causal effect, since not all pathomechanisms would produce such trends.
More importantly, there is substantial evidence of interactions
among physical exposures, so that (for example) jobs requiring both
repetitive and forceful motions have a higher risk than jobs requiring
either exposure alone (65-67). The multifactorial nature of these
relationships must be taken into account in interpreting research
findings. A ``low'' level of muscular exertion would seem to be safer
than a ``high'' level of force, everything else being equal; but if the
low force must be sustained for an excessive period of time, then the
prolonged duration of the exertion may render it as hazardous as a
brief but more strenuous exertion (6). Thus, the exposure-response
curve for each exposure should ideally be described as a function of
the level of each other exposure that might also be present in the same
job. There are obviously an enormous number of possible exposure
combinations, and not all have yet been rigorously studied by
epidemiologic methods.
Two misconceptions that have arisen during debate on this
literature are that (1) if an exposure-response relationship existed,
it would necessarily be linear or monotonic; and (2) that it would
necessarily indicate an exposure level that could be used to
differentiate between background risk of MSDs and an occupationally
elevated risk. First, an exposure-response relationship need not take
the form of a straight line through all data points; it may conceivably
be better described as a logistic curve, or as a step-function, or as
any other of a variety of mathematical functions. As only one example,
the analyses described above by Frost et al. (9) clearly showed a non-
linear exposure-response trend with cumulative exposure to repetitive
and loaded shoulder flexion. A non-linear relationship specifically
accommodates the likelihood that some physical activity is beneficial
and that only at more extreme levels do adverse health effects occur,
another point advanced in supposed disagreement with the evidence
summarized here.
Secondly, an exposure-response trend does not necessarily indicate
a single exposure level that unambiguously differentiates risk from no
risk. On the contrary, a perfectly linear relationship would by
definition not provide a clear threshold level. This is especially true
if exposure is treated as continuous and the relationship fits a
straight line through the origin, in which case each small increment in
exposure increases the probability of an adverse health outcome and,
extrapolated downward, there may be no discernable point without excess
risk above the zero exposure level.
When epidemiologic data indicate a good fit with a continuous
exposure-response relationship (rather than a step function, for
example), the designation of a permissible exposure level is a policy
decision rather than a judgment following inevitably from the
scientific data. Several authors have called attention to the
complexity of this process of utilizing exposure-response data for
quantitative risk assessment in the multi-dimensional domain of
physical ergonomics (e.g., 2, 58, 64, 68, 69). It is reasonable to
conclude, as these experts have done, that there is a need for
continuing study of those relationships and interactions, and at the
same time that it is appropriate to implement the scientific knowledge
in hand in order to prevent at least part of the work-related morbidity
that is presently occurring within the American workforce.
psychosocial factors and msds
Another type of stressor that has received increasing interest with
respect to MSDs is that of psychosocial factors. The term
``psychosocial'' is used in a variety of ways by different authors,
which has led to tremendous confusion both in the scientific literature
and in public discussion. It is critical to distinguish between
psychological attributes of individuals--such as personality, coping
skills, motivation or mood states--and the strain imposed on
individuals by features of their work environment resulting from the
organization of production activities. Work organization factors--task
structure, the division of labor, and skill utilization--are partial
determinants of physical load as well as of psychological job content
and constraints that may cause workers to experience ``stress.''
According to one widely used, internationally standardized
measurement approach (Job Content Questionnaire), there are three key
measures of psychosocial job characteristics: psychological job
demands, decision latitude, and social support (70-72). Decision
latitude is based on the worker's decision authority and the worker's
discretion over skill use, i.e., the worker's ability to control his/
her own work process and to decide which skills to utilize to
accomplish the job. Psychological job demands reflect both physical
pace of work and mental work load, especially time pressure in
processing or responding to information. In this model, high
psychological job demands in combination with low decision latitude
result in residual job strain and, over time, chronic adverse health
effects such as cardiovascular disease.
Clearly, these psychosocial features of the work environment are
under the control of the employer just as much as are physical factors
such as work pace and tool attributes. In fact, there is a recognized
overlap between some physical and psychosocial exposures; the
experience of performing a repetitive, monotonous task on a machine-
paced assembly line can be described equally well in terms of
stereotyped, repetitive motion patterns with rigid pacing and few rest
breaks, and as ``poor'' psychological job content, with few
opportunities to make decisions, work collaboratively with coworkers,
utilize existing skills or learn new ones. The relationship of work
organization factors with psychosocial strain has also been
demonstrated by intervention studies showing that increasing worker
participation in decision-making can resolve physiological strain
linked to high levels of demands over which the worker had no control
(72).
The occupational psychosocial stressor most consistently associated
to date with musculoskeletal disorders is lack of decision latitude or
autonomy (73). However, the evidence regarding a causal relationship
with MSDs is still quite limited, and several reviews have concluded
that the epidemiologic evidence is relatively weak. On the other hand,
the known physiological effects of psychosocial strain at work include
several plausible mechanisms by which the musculoskeletal system could
also be affected: adverse circulatory patterns; high levels of
sympathetic nervous symptom arousal with general central nervous system
consequences as well as endocrine system impacts on circulating
hormones; tonic activation or ``psychogenic'' muscular tension; and
interference with normal muscle and tendon repair processes (e.g., 74-
79). These postulated mechanisms deserve further study, but in the
meantime the literature on these associations should not be regarded
less critically than the literature on physical risk factors.
summary of the epidemiology
In summary, the epidemiologic evidence linking physical ergonomic
exposures at work with risk of MSDs is extensive, biologically
plausible, and methodologically adequate to inform primary prevention.
Numerous reviewers have concluded that ergonomic exposures such as
repetitive work, heavy lifting, forceful manual exertions, vibration,
and postural stress are causally related to the occurrence of
musculoskeletal disorders affecting neck, shoulder, hand/wrist, and
back. New research has strengthened the evidence supporting these
conclusions. There is substantial evidence of increasing risk with
increasing exposure, and of interactions among physical exposures.
These relationships have been found in studies of specific workplaces
as well as in samples of the general population. The available
longitudinal evidence generally confirms, in general terms, the
conclusions previously drawn from cross-sectional studies regarding the
etiologic association between working conditions and UE MSDs. The
impact of physical exposures at work cannot be explained away by
demographics (e.g., age or gender), medical history, or other
attributes of individuals.
There is an international near-consensus that effective prevention
of these disorders necessarily involves, among other measures,
reduction of workplace exposure to ergonomic risk factors, and several
eminent scientific reviewers have specifically called for regulatory
action, even given imperfect epidemiology and understanding of
pathomechanisms to date (e.g., 57, 69). Research agencies of the
European Union have endorsed ergonomics standards and presumptive rules
for identifying work-related MSD cases (63, 80). Among the U.S.
organizations reaching similar conclusions are NIOSH (1997), the
National Academy of Sciences (1998, 2001), and ACGIH (1999).
Costs of work-related MSDs
In addition to the human pain and suffering associated with MSDs,
other losses are externalized to workers, with adverse financial and
psychosocial impacts. There are also costs to employers through
workers' compensation claims, scrap and decreased production quality,
medical insurance premiums, labor turnover, and adverse impacts on
labor relations, although many of these are not linked by traditional
accounting methods to ergonomic problems per se. The proportion of
these injuries and illnesses that are work-related are by definition
preventable, as are their costs to employers, to workers, and to
society. Several have estimated that the real costs to employers,
including ``indirect'' or ``hidden'' costs, of workplace injuries and
MSDs can range from 2 to 3.5 times the amount paid in workers'
compensation cases (81-84).
However, it cannot be assumed that market-driven cost-benefit
calculations will be sufficient to motivate worker protection, because
firms typically emphasize short-term costs over long-term and because a
large proportion of these costs are not identified by traditional
accounting methods as due to ergonomic problems in the work process
(82). Furthermore, fundamental work organization features are rarely
questioned; on the contrary, modifications to increase productivity and
profitability, such as just-in-time systems, lean production and total
quality management or continuous improvement, appear to have
intensified job demands for workers (85).
Workers experience other financial losses--some covered by
compensation and others not--including the cost of medical care and
lost work time, lost future earnings and fringe benefits, reduced job
security and career advancement, lost home production and child care,
and home care costs provided by family members (81, 86). Non-monetary
losses include pain and suffering, family relations, sense of self-
worth and identity, social and community relationships, and
recreational activities (84, 87). These costs may accrue for many
years, because of the long duration of many MSDs; the 5-year rate of
increase in joint pain after retirement was higher among French
subjects who had held jobs with heavy physical work load (31). More
generally, disability retirement is disproportionately likely when
people work in ergonomically stressful jobs such as heavy physical
labor or repetitive tasks (30, 88).
Underreporting of MSDs in the workplace
The magnitude of MSD under-reporting through administrative data
bases has been noted repeatedly. For example, in one automobile
assembly plant, more than one-half of workers selected at random had
unreported back or shoulder disorders on interview or examination (10,
89). However, only about 20 percent of workers with a serious episode
of musculoskeletal pain appear to have sought in-plant medical
attention (83). Less than one percent of medical visits for MSDs were
flagged as workers' compensation cases, although 17 percent had work
restrictions, almost 8 percent resulted in lost work time, and 5
percent required outside medical treatment. Many workers reported
seeking medical care from outside providers.
Others have also shown that the frequency (and therefore the cost)
of work-related MSDs is severely underestimated, by as much as 60
percent, when relying on traditional administrative data sources such
as workers' compensation records and OSHA logs of recordable injury and
illness (90, 91). Even among unionized auto manufacturing employees,
who should perceive higher job security than many other workers, only
25 percent of those with work-related MSDs filed a compensation claim
or applied for benefits (92). The reasons for under-reporting by
employers and by workers likely include failure to recognize work-
relatedness; concern about job security; workplace incentives for
supervisors to discourage reporting; employee preference to avoid the
workers' compensation system and obtain medical care coverage through
private insurance, anticipated rejection of the claim, and even denial
of the injury itself because of financial need or a sense of self-worth
contingent on providing for oneself and one's family (92-98).
Under-estimation of MSD frequency also results from injured workers
leaving the workplace, i.e., the ``healthy worker effect,'' also
referred to as a survivor or selection bias. Not surprisingly, workers
who develop musculoskeletal disorders in ergonomically stressful jobs
are disproportionately more likely to transfer to less exposed
positions or to leave the workplace altogether (18, 99-103). In the
automobile assembly plant studies cited above (10, 89), almost 75
percent of both the back and shoulder cases reported difficulty in
doing their current or past jobs, and about one-third had voluntarily
transferred out of previous job assignments because of pain and
impaired performance.
The significance of this survivor effect is that it artificially
reduces the risk measures that can be determined from the population,
because the most exposed and affected individuals are missing from the
data set. Such a bias masks evidence of exposure-response
relationships, meaning that positive associations found in these
studies would likely have been even stronger if those subjects could
have been included.
Effectiveness of Ergonomics Intervention Programs
The potential to reduce MSD occurrence by reductions in
occupational ergonomic exposures is demonstrated in principle by the
occurrence of attributable morbidity itself. The proportion of musculo-
skeletal injuries and illnesses that are work-related are by definition
preventable, as are their costs to employers, to workers, and to
society. For example, it has been estimated that at least 50 percent of
all work-related musculoskeletal disorders among the working population
could be prevented by appropriate ergonomic job design (104, 105).
Policy-making on other occupational hazards has not required separate
intervention studies; if higher exposures lead to higher prevalence or
incidence, then it follows that reductions in exposure would lead to
reductions in morbidity.
Some scientific evaluations of ergonomic programs have been
undertaken, and these have shown mixed results. A key problem is that
any workplace is a highly dynamic institution. Rather large and
expensive studies are needed to address all possible risk factors for
MSDs in a rigorous manner, and yet the scientific investigator has no
control over external or internal events that might occur during the
study period. After the study has been initiated, the employer might
reverse a decision to implement fully a set of ergonomics
recommendations, or a facility might be closed or downsized, or new
national legislation on disease reporting might be introduced (106).
Nevertheless, the scientific literature contains numerous examples
of intervention studies that document the practical and economic
feasibility of workplace ergonomic programs. Effective abatement
measures range from well-designed training programs to workstation
redesign (107). Reductions in frequency and/or severity of work-related
MSDs have been demonstrated in manufacturing as well as in other
economic sectors. For example, in motor vehicle manufacturing,
ergonomic control measures have been effectively implemented both at
the level of the job and in the organization of the production process
(e.g., 108-110). Decreases in MSDs among VDU operators can similarly be
achieved by provision of adjustable furniture, training sessions to
facilitate workers' knowledgeable adjustment of workstations and work
schedules, and early reporting systems that aided employers in
assisting individual workers before they became too severely injured to
benefit from workplace measures (61).
The most effective ergonomics programs appear to be those with
multiple, coordinated activities, including workstation improvements,
provision of adjustable furniture, training to facilitate workers'
knowledgeable adjustment of workstations and work schedules, and
enhanced medical surveillance and management systems that aid employers
in assisting individual workers before they became too severely injured
to benefit (111-120). Shannon et al. found that, in general, lower
injury rates are consistently associated with workplace characteristics
such as workforce empowerment and top management's active leadership
plus delegation of decision-making authority regarding occupational
safety (121).
The economic benefits of such improvements should be taken into
account when attempting to estimate the cost of ergonomic
interventions. It has been reported that tasks identified by workers as
having the highest physical demands were far more likely than other
tasks to result in quality defects that were not detected until the
final inspection stage (122), and that an automobile assembly system
designed on the basis of ergonomic principles reduced through-put and
idle time, improved car quality, enhanced production flexibility and
operator competence in handling a varied mix of vehicle options, and
reduced production space requirements (109). Pay-back periods could be
substantially less than one year if full-cost accounting methods were
used to assess comprehensively both the costs and benefits of ergonomic
programs (123).
Conclusions
Many employers voluntarily utilize ergonomic principles to improve
working conditions, and they often report economic and other benefits
from such programs. Nevertheless, work-related musculoskeletal
disorders still occur with high frequency. Thus we must conclude that
existing incentives are not sufficient.
Not all MSDs occur in relation to work demands, but individuals
with high exposures to ergonomic stresses are at substantially
increased risk. The considered opinion of many scientists,
internationally, is that the scientific literature on work-related MSDs
overwhelmingly demonstrates a causal relationship between occupational
physical ergonomic stressors and musculoskeletal disorders.
The fundamental principles of public health practice emphasize the
prevention of injury and illness. While there may be debate about the
specifics of what an ergonomic standard should contain, there should no
longer be any debate that some MSDs can be prevented. Workplace
ergonomic programs, including early reporting, training, and job
redesign, are a feasible and effective means for reducing the
occurrence and severity of MSDs. Public policy measures are required to
ensure prevention of unnecessary injury, illness and disability.
Senator Specter. Thank you very much, Dr. Punnett. We turn
now to Dr. Franklin Mirer, Director of Health and Safety,
United Auto Workers.
STATEMENT OF DR. FRANKLIN E. MIRER, DIRECTOR, HEALTH
AND SAFETY, UNITED AUTO WORKERS
Dr. Mirer. Thank you very much, Senator, for the privilege
of testifying here. And I can tell you that in the auto
industry we do have a consensus. We have a consensus that there
are work-related musculoskeletal problems. It is our leading
cause of injury and illness.
Senator Specter. Employers agree with that?
Dr. Mirer. Yes, they do. And we have consensus on how to
measure it using pretty much the same measures across three
auto companies. We have consensus on how the program ought to
be structured. That is our ergonomics program. And we arrive at
that under a deadline which is the end of the auto contract.
Each round of auto bargaining, we improve the ergonomics
program. Now, we do not have a consensus that a standard is
needed, although I think we would be pretty close to a
consensus that the rest of the industry, including our parts
suppliers, ought to be doing a better job. And we are
continuing in the effort to do that, both the UAW and with some
limited support from management. So this is kind of a--some of
this argument is alien to us.
Now, yesterday, I was called by one of our several hundred
hourly ergonomics reps, local union reps, this one from a parts
plant in Flint. She was preparing an invited presentation to a
symposium at the American Industrial Hygiene Association in New
Orleans.
She is their local expert on the workings of government,
having been one of 20 UAW local union witnesses who testified
on the standard in Washington, Chicago and Portland. And she
had the pleasure of being cross-examined by Mr. Fellner at time
to clarify her answers. She told me as recently as----
Senator Specter. I'm sorry. I didn't hear that. She had the
what?
Dr. Mirer. She had the pleasure of being cross-examined by
Mr. Fellner.
Senator Specter. I thought that is what you said.
Dr. Mirer. She told me that as recently--never laid a glove
on her.
She told me that as recently as this Tuesday, a member
approached her on the plant floor to ask if they were going to
lose ergonomics because of the vote in Congress. She says that
fear has been raised in local union meetings repeatedly on the
plant floor the day after the Senate vote.
And I submit that as evidence that the real experts, the
hourly people doing ergonomics in the plant, the engineers, the
shop floor workers all know what it is about and all think it
is needed.
And her answer was, do not worry, we have ergonomics in the
contract with UAW. We are never going backwards.
But her problem is, and everyone's problem is it is hard to
get upfront money to fix problems in good economic times, in
the recent good economic times. Now that it is getting harder,
preventive maintenance even to keep production running smoothly
is hard to come by.
I am afraid we are going to be doing some sideways
stepping. Our major employers foresaw no changes required in
their ergonomics programs as a result of the new standard. And
we are moving to enhance it.
But we all know that we sought that standard as a safety
net against future cutbacks and as a floor for building on in
other facilities. So we fear that we might end up with the
safety net gone in free-fall or climbing on air.
Now, very quickly in terms of effectiveness of programs, 60
percent of the injuries in the auto sector are musculoskeletal
disorders. Practical ergonomics programs became fully effective
in 1994 really, and since then we have shown a 35 percent
reduction averaged over the whole three sectors in injuries.
But that is an average. Some places are doing better than
others. Our methods for relieving ergonomic stresses and
procedures for carrying out practical ergonomics are
established. We teach that scientific basis using some of these
researchers to local union representatives.
We have funded research. A lot of this research has been
conducted in the auto industry including some joint funding and
NIOSH funding of Dr. Punnett's work. It is pretty
straightforward.
So the consensus in manufacturing, on how to go forward,
how to design equipment, how to measure stresses, how to
retrofit problems, some of this information is on open web
sites of the industry.
Where we do not have consensus and where as you have heard
here, actually, it might be close to consensus but they are
demanding unanimity, we do not have consensus on the need for a
standard or some of the fine details of the standard.
prepared statement
But everybody is doing this more or less the same way than
are trying to take care of their workers and get a product out
the door, a quality product out the door on time. And we need
that codified, the practices of the industry leaders codified
so we can pull along the followers, the laggards and the
outlaws. Thank you very much.
[The statement follows:]
Prepared Statement of Dr. Franklin E. Mirer
This testimony is on behalf of the International Union, United
Automobile, Aerospace and Agricultural Implement Workers of America,
UAW and its 1.3 million active and retired members. Equally
importantly, this testimony is on behalf of tens of millions of
American workers exposed to ergonomic hazards who are not represented
by a labor union.
UAW members assemble vehicles and make parts for the Big 3 auto
makers, and also produce 18-wheelers, construction equipment,
locomotives and the Space Shuttle. Their employers are industrial
giants. We also represent nearly 300,000 employees of 1,500 private and
public employers in 2,800 bargaining units whose average size is 100.
In addition, our units include warehouses, schools, cafeteria workers,
health care and social service agencies. These statistics demonstrate
the depth and range of the UAW's experience with ergonomics programs in
both manufacturing and non-manufacturing sectors.
The UAW's extensive experience with ergonomics programs holds
answers to all the questions the members of this Subcommittee pose: Is
an OSHA ergonomics standard needed? Is there sound science to support
an ergonomics standard? Is an ergonomics standard consistent with
industry practice? Is an ergonomics standard feasible? Is an ergonomics
standard applicable and feasible in all sectors of the economy? The
answer to each of these questions is a resounding ``yes.'' The actions
such a standard would require are not only feasible, they are already
commonplace in hundreds of UAW-represented workplaces.
The UAW appreciates that this Subcommittee is interested in hearing
the current state of the debate on ergonomics. We would have preferred
that this debate had been more fully aired before the Senate voted on,
and the President signed, the Resolution of Disapproval of OSHA's
ergonomics program standard.
The UAW strongly supported OSHA's ergonomics program standard as a
modest, but critical, first step toward abating the largest single
cause of injury and disability among American workers generally, and
UAW members in particular. The OSHA rulemaking provided an oasis of
science amid a desert of lobbying and sound bites. Then, the logic of
power overwhelmed the power of logic, and the rule in place was
repealed. We are not here to re-debate the disapproval resolution,
however. We are here to argue that Congress, having eliminated the
protections afforded by the ergonomics standard, should mandate that
OSHA issue another enforceable ergonomics standard regulation by a time
certain.
The purpose of Federal standards is to codify the practices of
industry leaders so that industry followers can adopt those practices
while exposing industry laggards and outlaws for what they are. There
are literally thousands of consensus safety standards, set by industry
to regulate itself. The large majority of OSHA standards are actually
outdated, 1970's vintage consensus standards. OSHA standards, adopted
through an open, evidence-rich process, may stretch the industry
leaders, but they are particularly hated by the laggards because
management has to comply, rather than merely being invited to comply.
The UAW testimony today will emphasize the following key points:
1. Ergonomics programs are the only means to prevent the majority
of injuries suffered by American workers in the automobile industry,
and the manufacturing sector generally. Approximately 60 percent of
injuries in the auto sector are muskuloskeletal disorders.
2. Practical ergonomics programs are in place in hundreds of
worksites and have set the stage for major progress.
3. The Bureau of Labor Statistics 1998 and 1999 surveys show the
effectiveness of UAW-negotiated ergonomics programs.
4. Methods for measuring and relieving ergonomic stresses and
procedures for carrying out practical ergonomics programs have been
developed and verified over the last decade. The science is well
established.
5. The principal need over the next decade is accelerating
abatement of exposure to physical stresses.
6. The UAW has developed and implemented an ergonomics model for
small manufacturing suppliers and office and professional facilities
which demonstrates that ergonomics is necessary and feasible in such
facilities. These programs also establish industry recognition of MSD
risk factors and the elements of a program needed to protect employees.
7. The OSHA rulemaking process was itself a massive data collection
and analysis effort that collected information not previously available
to support an ergonomics standard.
8. Both the second National Academy of Sciences 2001 review and the
new ACGIH standard for Hand Activity Level limit demonstrate a
scientific consensus in support of ergonomics interventions.
9. In conclusion, the ergonomics standard is necessary, feasible
and appropriate.
Each of these points is discussed in detail below:
1. Ergonomics programs are the only means to prevent the majority
of injuries suffered by American workers in the automobile industry,
and the manufacturing sector generally. Approximately 60 percent of
injuries in the auto sector are muskuloskeletal disorders.
The need for ergonomics abatement is most clearly shown in the
Bureau of Labor Statistics (BLS) Disabling Injury reports.\1\ These
studies compile employer-supplied data on the types and causes of
injuries and illnesses that result in days away from work. The employer
data are a sample of OSHA 101 forms for cases with days away from work.
---------------------------------------------------------------------------
\1\ Most recent detailed industry data available are for 1998.
These analyses are for the 1997 database, which is not materially
different.
---------------------------------------------------------------------------
OSHA relied on this same database. We concur with OSHA that these
employer-supplied data probably under-report musculoskeletal disorders.
However, the data portray the full extent of the problem.
In the motor vehicle parts sector (SIC 3714), the employment
category of in the auto industry with processes most common to other
manufacturing industry and with the most small establishments, 54
percent of disabling conditions are identified by management as strain
or sprain injuries and various cumulative trauma diagnoses which are
properly grouped as MSD's. In addition, about 20 percent of disabling
injuries were in the ``other'' category, which includes some MSD's.
Therefore, the large majority of disabling conditions are MSD's. For
auto parts, 40 percent of injuries were coded as arising from
repetitive motion or overexertion, with an additional 11 percent in the
``other'' category. Back injuries are the largest single diagnosis in
this sector, 22 percent, and shoulder injuries are 7 percent. Back and
shoulder injuries are almost entirely of ergonomic origin. In short,
injuries preventable by ergonomics programs dominate the disabling
injuries in the motor vehicle parts sector, and manufacturing in
general.
These data demonstrate that the biggest problems now faced by
safety specialists and suffered by workers are hazards that can be
abated only by ergonomics programs.
2. Practical ergonomics programs are in place in hundreds of
worksites and have set the stage for major progress.
Every UAW-represented location in the Big 3 auto companies has a
labor-management ergonomics committee in addition to a labor-management
health and safety committee. These approximately 300 facilities employ
about 350,000 hourly workers and additional salaried personnel, and
represent a substantial fraction of the U.S. Gross National Product.
The two UAW-represented international transplant assembly plants use
the same structure. Labor and management representatives on these
committees are trained to analyze injury and illness data to identify
high injury jobs; to conduct risk factor analyses; and to identify
solutions to reduce ergonomic stresses. Dozens, if not hundreds, of
smaller UAW-represented parts suppliers have adopted this model as
well. UAW members in the service, clerical and public sectors have been
able to implement similar programs. These programs are described in
more detail below.
The common ergonomic abatement process used by these committees is
shown in the accompanying flowchart. Ergonomics is a continuous
improvement process with no clear endpoint. In fact, participants
believe that ergonomics improvement is integral to a high performance
manufacturing system, just as quality improvement is.
Initially, these UAW ergonomic programs grew from massive penalty
OSHA citations for failure to record injuries and illnesses, and from
citations under the General Duty Clause. The programs were later
codified in labor contracts. Labor and management representatives argue
about the best way to do things and whether change is fast enough, but
the need for an ergonomics process on this model is no longer in
dispute. Our ergonomics programs have been shown to reduce worker
injuries and to increase productivity.
Ergonomics program activity goes well beyond the vehicle assembly,
stamping, parts manufacturing and parts distribution facilities of the
Big 3 auto makers. Similar but less elaborate programs following the
same model, including job analysis methods and labor management
structure, have been implemented in many smaller UAW represented
workplaces. Ergonomics committees at these facilities are often trained
by UAW professionals. We have done this in parts plants, bicycle
plants, a health maintenance organization, in clerical settings and
among public employees.
3. The Bureau of Labor Statistics 1998 and 1999 surveys show the
effectiveness of UAW-negotiated ergonomics programs.
Analysis by the UAW of the most recent government statistics shows
that safety and ergonomics programs prevented over 69,000 occupational
injuries and illnesses in 1998 in the vehicle assembly and parts
sectors. Of these, at least 41,000 were musculoskeletal problems
prevented by ergonomics programs.
These data are derived from the Bureau of Labor Statistics' annual
injury and illness survey data for 1998, released in December 1999.
Reductions in injury rates reported for key UAW workplaces give strong
evidence for the effectiveness of UAW safety and health programs
generally, and especially for the value of our ergonomics programs.
The UAW believes that the motor vehicle assembly (SIC 3711), motor
vehicle parts (SIC 3714) and automotive stamping (SIC 3465) sectors
have gone farther than most others in implementing ergonomics programs.
My testimony concentrates on the auto parts sector. We selected 1994 as
the baseline, because that is when ergonomics programs were first
likely to be fully implemented, and also to obtain a five year period.
For the auto parts sector, the total case rate dropped 12 percent over
one year and 33 percent over five years, while the occupational illness
rate fell 17 percent over one year and 34 percent over five years.
Cumulative trauma disorders declined 13 percent and 24 percent
respectively.
Over this same period the total case rate, injury rate and CTD rate
fell slightly for all private employment, while the illness rate
increased by a small amount. The vehicle assembly rate however, dropped
5.5 times as fast as the national average over five years, while auto
parts dropped 4.5 times as fast. Percentage reductions were 40 percent
greater in vehicle assembly and 70 percent greater in parts
manufacturing compared to all employers combined.
The 1999 data, which did not become available until December 2000,
show an additional 5 percent drop in total rate across the three main
auto-related sectors. This evidence of continuing improvement was not
included in the record of the OSHA hearings.
These data show that ergonomics programs decrease the number of
worker injuries, with attendant savings to employers as well.
4. Methods for measuring and relieving ergonomic stresses and
procedures for carrying out practical ergonomics programs have been
developed and verified over the last decade. The science is well
established.
The important technical developments for effective ergonomics
programs emerged two decades ago, and the broad outline is now largely
in place. The driving force was combining the engineering and
biomechanics disciplines with medical science and epidemiology. The
University of Michigan and NIOSH are the key institutions that have
established the United States at the forefront of the science of
ergonomics. The technical developments include:
--Development of consistent methods to measure the physical stresses
on the human body. Stress is determined by the force exerted on
a body part, the frequency of the motion, and the posture of
the joint. The Force-Frequency-Posture paradigm is common to
both expert and checklist approaches to ergonomic analysis;
--Acceptance of expert ergonomic analysis for measurement of risk
factors according to these methods;
--Development of simplified non-expert approaches to measurement of
risk factors (checklists);
--Formulation of the NIOSH lifting guide and related biomechanical
models which take into account the weight of an object,
distance from the body, and motion of the body in lifting;
--Validated semi-quantitative risk factor checklists for hand, arm
and shoulder (upper extremity) cumulative trauma disorders;
--Diagnostic criteria for upper extremity CTD's;
--Standardized physical examination protocols for upper extremity
CTD's;
--Validation of symptom surveys and discomfort surveys
(psychophysical measures) as risk factor identification tools;
--Validation of risk factor checklist and symptom survey by workforce
personnel to identify high risk jobs and propose abatement
methods;
--Acceptance of the plant ergonomics committee model, especially lay
analysis of risk factors using standardized checklists.
These scientific developments rest on an enormous body of published
work as well as practical experience. In 1997, NIOSH published a
massive compilation of ergonomics studies. The UAW believes that the
NIOSH compilation and analysis of virtually all available studies of
work-related musculoskeletal disorders settles the question whether
there is sufficient science underlying ergonomics. The studies show
exposure-response relationships for ergonomic stress factors and
musculoskeletal disorders of each body part. NIOSH did an excellent
evaluation of hundreds of reports to show the weight and strength of
the evidence for cause and effect relationships, and conclusively
confirmed that increased stress causes increased injury.
Nonetheless, Congress subsequently funded a review of this issue by
the National Academy of Sciences.\2\ A steering committee was
established in May 1998, under the auspices of the NAS Committee on
Human Factors.
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\2\ The NAS ergonomics report responds to seven questions posed by
Congressman Livingston: 1. What are the conditions affecting humans
that are considered to be work-related musculoskeletal disorders? 2.
What is the status of medical science with respect to the diagnosis and
classification of such conditions? 3. What is the state of scientific
knowledge, characterized by the degree of certainty or lack thereof,
with regard to occupational and non-occupational activities causing
such conditions? 4. What is the relative contribution of any causal
factors identified in the literature to the development of such
conditions in (a) the general population; (b) specific industries; and
(c) specific occupational groups? 5. What is the incidence of such
conditions in (a) the general population; (b) specific industries; and
(c) specific occupational groups? 6. Does the literature reveal any
specific guidance to prevent the development of such conditions in (a)
the general population; (b) specific industries; and (c) specific
occupational groups? 7. What scientific questions remain unanswered,
and may require further research, to determine which occupational
activities in which specific industries cause or contribute to work-
related musculoskeletal disorders?
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NAS studies typically consist of literature reviews and
presentations at open meetings, followed by a report drafted by the
expert committee and reviewed by the Academy members and other peer
reviewers. The ergonomics study involved an open workshop attended by
66 leading technical experts. The UAW participated in this workshop
\3\, presenting evidence of our experiences with ergonomics programs.
The NAS issued a report on the study in 1999. The summary conclusion
was: ``Scientific research clearly demonstrates that effective work
place interventions are available which can reduce ergonomic hazards
and prevent musculoskeletal disorders. There is evidence that
interventions are cost-beneficial for employers.'' The report thus
validated the scientific conclusions cited by OSHA as the basis for its
decision to move forward with an ergonomic standard.
---------------------------------------------------------------------------
\3\ Lida Orta-Anes, Ph.D., ergonomist, UAW Health and Safety
Department, was invited to present a discussion paper on UAW
experiences and her views of the scientific evidence.
---------------------------------------------------------------------------
In 1998, Congress commissioned a second NAS study of the same
issues.
This section has summarized the state of knowledge when the
ergonomics standard was proposed and the hearings began. Below we
discuss subsequent scientific developments that further support the
need for an ergonomics standard.
5. The principal need over the next decade is accelerating
abatement of exposure to physical stresses.
Many case histories show improved health outcomes on jobs where
risk factors had been reduced. Many facilities report reduced injury
rates after implementing ergonomics programs. Scientific studies show
reduced injury rates and symptom complaints after job changes. These
case studies were reported in the NIOSH conference and are regularly
presented at professional meetings. The data presented above show
sector-wide reductions in MSD rates in the sector with the most
advanced ergonomics activities. These successes are reasons for
government to keep pressure on employers to abate ergonomic hazards.
The principal problem plant ergonomics committees report is not
being able to get high-risk jobs fixed in a timely fashion. High-risk
jobs are jobs where injuries have already been recorded. Solutions are
usually identified directly from the risk factor analysis: the job task
must be changed to reduce the force, limit the number of repetitions of
the same motion, or allow the worker to do the job in a neutral
posture.
Routine solutions include raising loads off the floor with lift
tables, adjusting the height of work, reducing the reach to get or
place parts, damping vibration, placing the tool or the work in a
fixture, reducing or counterbalancing tool weight. Many tricks of the
trade are known to engineers and workers alike. People from the
workplace know job changes that will allow the work to be done and
reduce the stresses. Virtually all these solutions improve quality and
efficiency and therefore increase productivity.
Nevertheless, to solve ergonomics problems and to reduce injury
rates in the long term, an employer has to invest time and money up
front. Unless pressure for job improvement is maintained, employers
will resist accepting their responsibility.
The principal improvement in ergonomics programs achieved in the
1999 round of auto contract negotiations was adoption of specific time
limits for the job improvement cycle. In all three auto agreements,
management committed that a job will be analyzed within two months of
the report of a work-related musculoskeletal disorder and modified to
abate identified risk factors within six months of completion of the
analysis. In addition, design criteria for new equipment are
incorporated into the joint new equipment safety reviews. Some of these
criteria are available to suppliers over the internet.
6. The UAW has developed and implemented an ergonomics model for
small manufacturing suppliers and office and professional facilities
that demonstrates that ergonomics is necessary and feasible in such
facilities. These programs also establish industry recognition of MSD
risk factors and the elements of a program needed to protect employees.
The UAW has implemented ergonomic interventions at approximately 45
smaller UAW-represented worksites over the past five years. The optimal
intervention involves all the elements of the OSHA standard, except
that MSD management typically falls short of the OSHA proposal.
The essential element of the intervention is training a worksite
ergonomics committee to analyze jobs and suggest interventions. In UAW-
represented facilities, this training is primarily conducted by peer
trainers, called Local Union Discussion Leaders (LUDL's). LUDL's are
full-time employees at UAW-represented facilities. They are shop floor
employees who move into a trainer position because of their interest
and demonstrated training skills. These persons are released from work
on union leave at UAW request to conduct training-related activities.
LUDLs assigned to ergonomics training are usually ergonomics committee
members at their home facility. They have all taken at least a 40-hour
course, conducted job analyses, received training technique instruction
and been fully evaluated by UAW Staff and University of Michigan
training evaluation staff.
Our experience with this training method indicates that because it
is based on hands-on activities, it ensures retention of information.
The small group discussion and problem-solving allows for direct
learning from peers with experience in the topic. The training includes
extensive case studies through the use of videos. In addition, it is
delivered at the site. It includes a component where participants
evaluate real jobs on the shop floor, in real time.
The UAW has implemented successful ergonomics programs using this
training at numerous small businesses, including Jaquith Industries
(Local Union 1128) in Syracuse, New York. With the completion of a
recent 40-hour Practical Ergonomics Training (PET) program, Jaquith
workers are now able to evaluate problem jobs and develop solutions.
Some jobs in this shop are presently being re-engineered to eliminate
job hazards. In a recent letter to the UAW Health and Safety Department
from Jaquith's owners, they praised and credited UAW's Health & Safety
Department grant staff for a professional job in helping them to assess
their ergonomics concerns and offering solutions to the problems they
faced.
Other small employers who have worked with the UAW to establish
successful ergonomics programs include: Recycle Ann Arbor (Local Union
157) in Ann Arbor, Michigan; Bosch Braking Systems (Local Union 2155)
in Johnson City, Tennessee; United Defense Systems (Local Union 683) in
Minneapolis, Minnesota; Sidler Corporation (Local Union 417) in Madison
Heights, Michigan; and AP Parts (Local Union 12) in Toledo, Ohio.
7. The OSHA rulemaking process was itself a massive data collection
and analysis effort that collected information not previously available
to support an ergonomics standard.
The Subcommittee should take note of the remarkably open nature of
an OSHA standard hearing. Prior to a hearing, OSHA issues the proposal
and explanation, and invites written comments. The hearing starts with
the OSHA team that wrote the standard appearing on stage taking
questions from all comers, industry and labor, explaining and defending
the proposal on the record. Then, OSHA presents experts who appear and
face questioning by all parties under the same ground rules.
After OSHA has laid out its proposal and its evidence, anyone with
an opinion can submit evidence and present oral testimony. However, the
price of appearing before the team that will write the standard is
taking questions from participants from industry, labor and OSHA, also
on the record. For questioning of witnesses during the ergonomics
hearings, labor and OSHA relied principally on subject matter experts
rather than on lawyers. United Parcel Service, the main opponent of the
ergonomics rule, requested two and a half days of testimony, then
dropped nearly all its witnesses and took just a couple of hours,
thereby crowding out other evidence and limiting the time of other
witnesses.
The ergonomics standard had been under consideration for ten years,
initiated by then-Secretary of Labor Elizabeth Dole. OSHA invited
stakeholders to participate in many meetings to discuss key issues in
the rule before a proposed standard was issued. NIOSH held an open
invitation national conference to present best practices. OSHA held a
series of regional open invitation best practices conferences. There
was every opportunity for pre-proposal input to all interested parties.
The UAW participated in many of these events. Participation included
several joint labor-management presentations of facility experiences.
A working draft of the ergonomics standard was reviewed by small
business representatives under the SBREFA process, beginning in
February, 1999. OSHA, together with the Office of Management and Budget
and the Small Business Administration created a panel to review and
comment on a working draft of the standard. The panel sought the advice
and recommendations of potentially-affected small entity
representatives, consulting with 21 persons. This included a face-to-
face meeting on March 24-26, 1999. The UAW notes with concern that
small business representatives were given special status and access to
rulemakers to ask questions and make comments before workers and the
public had an opportunity for similar input. Nevertheless, in
accordance with law, the SBREFA panel submitted a report to OSHA on
April 30, 1999.
The SEBREFA panel made 36 recommendations to OSHA concerning the
ergonomics standard. OSHA responded to each one of them, as detailed in
the preamble of the proposed rule. Some comments resulted in
modifications to the cost estimates of the standard. Others resulted in
clarifications or changes to the explanation of the regulatory text.
Finally, several changes in the regulatory text were made in response
to recommendations. These changes included: removing a provision that
employers must analyze jobs with ``known hazards;'' providing a step-
by-step incremental abatement process; and modifying the medical
management program to reduce potential cost to employers.
The UAW notes that some of the changes made in response to small
business recommendations--in particular the incremental abatement
process--later became the basis for criticism by business
representatives.
The OSHA hearings spanned 44 full days of testimony and questioning
in Washington, Chicago, Portland, and Atlanta, involved about 900
witnesses, and generated 18,833 pages of transcript. The full
transcripts were posted on OSHA's website to be downloaded and
reviewed, as well as lists of exhibits. This open access to the
complete record had no precedent in previous rulemaking.
The UAW presented testimony at three sites. Presenters included 11
local union representatives from automobile industry facilities; nine
local union representatives from other sectors, including parts
suppliers, agricultural implement, truck, appliances, joint ventures,
private sector clerical and public employees; the UAW co-project
manager for ergonomics from each of the three auto collective
bargaining departments presenting the joint program at that company;
and three Health and Safety Department representatives. The UAW also
submitted about 200 pages of written testimony and commentary as well
as training materials and ergonomics manuals developed by the joint
UAW-company programs. (The UAW notes that the jointly developed and
validated UAW-GM Risk Factor Checklist was recognized by OSHA as a
valid means of evaluating ergonomic risk factors.)
The UAW points out that the experiential data presented by local
union representatives and staff are rarely available to an agency or to
the public through the published literature. Yet, this evidence is
crucial to the practical validation and application of biomechanical
and epidemiological analyses in the real world. The OSHA process thus
created a large and valuable new base of data.
Additionally, OSHA presented several panels of leaders in
occupational medicine, ergonomic analysis, engineering and regulatory
analysis applied to ergonomics programs. These were all published
authorities whose work was available in the open literature. However,
the invited testimony made these persons available for questioning on
the specific points that management and labor stakeholders thought to
be material to a standard. The dialogue in the hearing transcripts
provides an additional large new base of data on which to develop
ergonomic knowledge.
The OSHA team that had drafted the proposed standard sat through
each of these hearings, as did the key labor and management
representatives.
8. Both the second National Academy of Sciences 2001 review and the
new ACGIH standard for Hand Activity Level limit demonstrate a
scientific consensus in support of ergonomics interventions.
On January 18, 2001, the National Academy of Sciences (NAS) and
Institute of Medicine (IOM) released their long-awaited report on
Musculoskeletal Disorders and the Workplace (``NAS II''). The report,
requested by Congress, confirms yet again that there is strong
scientific evidence that exposure to ergonomic hazards in the workplace
causes musculoskeletal disorders and that these injuries can be
prevented by ergonomic interventions.
The study was not an ivory tower effort. The study committee
traveled to Detroit, heard a presentation on the state of the art in
the auto industry, toured auto plants accompanied by UAW and Ford
staff,\4\ and heard from local ergonomics committee members, labor and
management, who do the work every day.\5\
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\4\ Dr. Bradley Joseph and Dr. Gordon Reeve, Ford Motor Company,
and Dr. Franklin E. Mirer, UAW Health and Safety Department.
\5\ Ford Livonia Transmission Plant and UAW Local 182, and Ford
Michigan Truck Plant and UAW Local Union 900.
---------------------------------------------------------------------------
The NAS II report confirms that the exposures addressed by the OSHA
standard--heavy lifting, awkward postures, repetition, force and
vibration--cause back injuries and/or upper extremity injuries like
carpal tunnel syndrome. It also found that a programmatic approach
tailored to individual workplaces, such as that set forth in the OSHA
standard, is the most effective means to reduce MSDs. Specific major
findings of the study include the following:
``There is no doubt that musculoskeletal disorders of the low back
and upper extremities are an important and costly national health
problem . . . In 1999, nearly 1 million people took time away from work
to treat and recover from work-related musculoskeletal pain or
impairment of function in the low back or upper extremities.
Conservative estimates of the economic burden imposed, as measured by
compensation costs, lost wages, and lost productivity, are between $45
and $54 billion annually.'' (Page ES-1)
``The panel's review of the research literature in epidemiology,
biomechanics, tissue mechanobiology, and workplace intervention
strategies has identified a rich and consistent pattern of evidence
that support a relationship between the workplace and the occurrence of
MSDs of the low back and upper extremities.'' (Page ES-3)
``The panel concludes that there is a clear relationship between
back disorders and physical load; that is, manual material handling,
load movement, frequent bending and twisting, heavy physical work, and
whole-body vibration. For disorders of the upper extremities,
repetition, force and vibration are particularly important work-related
factors.'' (Conclusion 3, Page 11-10)
``The weight of the evidence justifies the introduction of
appropriate and selected interventions to reduce the risk of
musculoskeletal disorders of the low back and upper extremities.''
(Page 11-2)
``To be effective, intervention programs should include employee
involvement, employer commitment and the development of integrated
programs that address equipment design work procedures and
organizational characteristics.'' (Conclusion 8, Page ES-6 and 11-2)
Opponents of an ergonomics regulation promptly issued press
releases stating that this report discredited the scientific basis for
the OSHA standard. We ask the members of this Subcommittee to judge for
yourselves.
Equally compelling was action by the American Conference of
Governmental Industrial Hygienists (ACGIH) on December 10, 2000. The
ACGIH is the dominant private entity that issues occupational health
standards. ACGIH standards are internationally recognized and given
deference by many governmental authorities outside of the United
States.
The ACGIH preface states:
``ACGIH recognizes work related musculoskeletal disorders (MSDs) as
an important occupational health problem that can be managed using an
ergonomics health and safety program--Some of these disorders fit
established diagnostic criteria such as carpal tunnel syndrome or
tendinitis. Other musculoskeletal disorders may be manifested by
nonspecific pain. Some transient discomfort is a normal consequence of
work and is unavoidable, but discomfort that persists from day to day
or interferes with activities of work or daily living should not be
considered an acceptable outcome of work.''
The ACGIH adopted a Threshold Limit Value (TLV) for hand activity
level and issued a notice of intended change to adopt a TLV for
lifting.
Hand Activity Level is a numerical function of peak hand force,
frequency and duration of exposure. The TLV includes an action level,
below the exposure limit. The standard notes that:
``Professional judgment should be used to reduce exposures below
the action limits recommended in the HAL TLV's if one or more of the
following factors are present:
``--Sustained non-neutral postures such as wrist flexion, wrist
extension, wrist deviation, or forearm rotation;
``--Contact stresses;
``--Low temperatures; or
``--Vibration.
``Employ appropriate control measures anytime the TLV's are
exceeded or an elevated incidence of work-related musculoskeletal
disorders is detected.''
9. In conclusion, the ergonomics standard is necessary, feasible
and appropriate.
The underlying premise of any OSHA standard is that an employer who
knows a job has injured an employee must take feasible steps to make
the job safer. Few would disagree with the propriety of this premise.
This applies equally to ergonomics. The UAW, our auto industry
employers, and many smaller employers have demonstrated that ergonomics
programs are a ``win-win'' for both management and employees. In many
of our worksites, ergonomic risk assessment techniques are applied
predominantly by hourly workers who, in turn, have been trained by
other rank-and-file workers. These methods both measure hazard and
validate abatement.
Ergonomics programs works. It is time to get down to the business
of applying ergonomics.
Senator Specter. Dr. Mirer, from what you have said, then,
does the auto industry, UAW and manufacturers need an
ergonomics regulation or have you not pretty much solved the
problem yourself?
Dr. Mirer. No. The problem is never solved and we bargain
over it actually every 3 years. It is a continuous improvement
process. And we need the standard as a safety net for when
times get hard.
Senator Specter. The standard as a safety net. But on an
ongoing basis you are pretty well working it out from what I
hear in your testimony.
Dr. Mirer. We have been making progress in good times. We
are going into bad times now and things----
Senator Specter. Well, your experience is obviously not
determined in there for all of the industry. You have a very
mature industry in automobiles. And you have good bargaining
power. And the UAW and the employers, when you say consensus,
that is nice to hear, even though it is limited. But you would
still like to have an ergonomics regulation from a Federal
Government, but as you say from a safety net.
Dr. Mirer. For the three car companies, for the IPS sector,
for the supplier sector, the small plants sector, we absolutely
need that standard as a floor that we can build on and move
forward.
Senator Specter. You need a standard forum from some of the
suppliers. Well, has the UAW not been successful on your
bargaining strength to get a reasonable result from that group?
Dr. Mirer. We are far from where we ought to be in that
group.
Senator Specter. How do you account for the difference
being far from where you ought to be in that group in contrast
to where you are in the industry generally?
Dr. Mirer. It is a contrast of combination of collective
bargaining, technical resources and the ability of suppliers to
turn over their workforce and run away.
Senator Specter. Well, I think that the model that you have
described though from the most of the industry of the UAW is a
good one to be followed. Maybe it needs some sharpening up on
it, but it is a lot better to hear that you need a safety
standard than you are on each other's throats and cannot agree
to anything.
Dr. Mirer. Absolutely.
Senator Specter. Dr. Hadler, what do you think of Dr.
Punnett's testimony that musculoskeletal pain is proportionate
to physical work? I do not have her exact words. They were too
complicated and too long and I could not write them all down
but that is the thrust of it.
Dr. Hadler. When I was a medical student, epidemiologists
observed that the risk for Down's Syndrome, trisomy 21, was not
uniform in sibships. The youngest child was more likely to be
afflicted with this congenital disorder.
Senator Specter. Does this turn out to be responsive to my
question?
Dr. Hadler. It is a direct response.
Senator Specter. I am not sure about that. I disagree with
that already.
But if it is indirect, I will take it.
Dr. Hadler. We are working on consensus. Give me about
another two paragraphs.
Senator Specter. Okay.
Dr. Hadler. That leads to the hypothesis and research----
Senator Specter. Chairman gets very impatient when you have
got about 40 witnesses.
Dr. Hadler. I hear you. I will be within my 5 minutes.
Senator Specter. I am not necessarily giving you 5 minutes,
Dr. Hadler. I want you to respond to my question. You have had
5 minutes.
Dr. Hadler. The answer is, if I need to respond directly,
and the analogy would help understand it, is that----
Senator Specter. Go ahead with your analogy. It will be
shorter than my interruptions.
Dr. Hadler. That lead to hypotheses and research as to what
was it about the multiparous uterus that caused the fertilized
egg to divide abnormally.
Several years later, epidemiologists returned to this issue
to test whether they had missed the real association. The
younger the child in the sibship, the older the mother. Could
it be that the likelihood of bearing a child with Down's
Syndrome associated more with the mother's age than the birth
rank. The answer proved to be yes. The old hypothesis was
superseded and research shifted to the biology of the aging
ovary.
Several years later, epidemiologists returned to this issue
to test whether they had missed the real association. The older
the mother, the older the father. Could it be? The answer was
yes and no. The likelihood of bearing a child with Down's
Syndrome was associated with both maternal and paternal age.
The old hypothesis was superseded and research shifted yet
again.
That is the scientific method. We learn from the old
hypotheses and the old false starts and we move on. Today no
one would consider studies of the microenvironment of the
multiparous uterus as relevant to the pathogenesis of Down's.
For 60 years, science has sought associations between physical
demands of tasks and the likelihood of suffering----
Senator Specter. Which paragraph are you on now?
Dr. Hadler. That is the direct answer. The physical demands
of task and the likelihood of suffering disabling regional back
pain. For 30 years, there have been parallel studies between
physical demands of tasks and disabling arm pain.
Associations have been found, but they are inconsistent and
weak. There were hints 30 years ago, but science has really
risen to the challenge in the past decade, the challenge of
asking whether a more important association was being ignored.
A number of cross-sectional and longitudinal studies have
attempted to probe for associations between disabling regional
back or arm pain and aspects of both, the physical content of
tasks and the psychosocial context of work.
The result of these multivariate studies is that the
associations with the wide range of physical content of tasks
that has been studied are weaker and even more inconsistent.
The associations with the psychosocial context of work are also
weak but they are more consistent and generally subsume the
associations with the physical content of tasks.
I could belabor this new literature. It deserves scrutiny.
However, I cannot applaud the insistence on relying on the
older literature in the systematic reviews that are promulgated
by NIOSH and the NRC and Dr. Punnett in her statement.
Any study that considers only the association between the
physical demands of tasks and likelihood of a disabling
regional musculoskeletal disorder is out of date, even if it is
ongoing or proposed. The state-of-the-science has moved beyond
the testing of that hypothesis to newer hypotheses that promise
to be more informative.
That is my direct answer, sir. Can I elaborate on it?
Because I had planned to.
Senator Specter. I do not know whether it is possible to
elaborate on it.
I have just been reading the six paragraphs and I would
have to study and dissect it to understand it. Dr. Punnett,
there are two questions for you. First, did you understand the
analogy to Down's Syndrome?
Dr. Punnett. Well, Senator, I think what Dr.----
Senator Specter. I have not asked the second question yet.
But go ahead.
Dr. Punnett. I think I guess the very short answer is I
think I might have understood it.
Senator Specter. Well, when Dr. Hadler disagrees with your
conclusion of muscular pain proportionate to physical work, I
am going to have to study his statement so that I can
understand his reasoning on it.
Dr. Hadler. Can I illustrate with an example?
Senator Specter. No. No. You cannot. All right. Go ahead.
Dr. Hadler. Let me tell you briefly about two small area
analyses, since they are very easy to follow. There are large
companies that have multiple work sites, each with similar
facilities and similar demographics of the workforce. The
incidence of disabling back or arm pain varies from site to
site, sometimes dramatically.
That offers the opportunity to explore whether measurable
differences in task content, demographics, or psychosocial
context associate best with the variability in the incidence of
the disabling regional disorders.
Independently, investigators from NIOSH and myself perform
such a small area analysis in U.S. West directory assistance
operators. Neither NIOSH nor I could explain the site-to-site
variability in the incidence of disabling arm pain by any
aspect of the content of the task.
However, multiple aspects of the psychosocial context of
the work did associate: Fear of redundancy, work pressure, lack
of decision authority, to mention a few.
Dr. Mirer. That will go over real well in Flint.
Senator Specter. Well, I have the statement and I am going
to have to study it candidly to understand it.
Dr. Punnett. Senator Specter, could I just elaborate a
little bit on my earlier very quick response?
Senator Specter. Just a little bit.
Dr. Punnett. I believe that what Dr. Hadler was trying to
say was that he thinks that the hypothesis regarding physical
load factors is out of date. He just actually cited a rather
old study himself.
But I think that the reviewing process which has gone on in
the scientific peer-reviewed literature, Dutch reviewers,
British reviewers, German reviewers, Japanese investigators
really are increasingly coming together very much in line with
the NAS conclusions. And the evidence is in fact that even
taking account of psychosocial factors, the evidence in favor
of physical load factors is consistent and continues to be
strong.
Senator Specter. Dr. Bigos, have you had an opportunity to
examine this report that Dr. Barondess referred to?
Dr. Bigos. Yes, I have.
Senator Specter. And Dr. Barondess articulated the issue
better than I had, which would not necessarily take a whole
lot, when he said it adds incremental risk. So it is not a
causative factor but an incremental factor. Do you disagree
with that?
Dr. Bigos. I think that the data is not strong enough to
make that particular association in a way that we can act on it
specifically. I think incremental risk is kind of like
cardiovascular disease. It is a U-shaped phenomena that we see
all throughout the physical aspects of nature.
That is, people who do not and people who do participate in
something seem to do poorer than people who do things in
moderation, whether it be exercise or alcohol as we are finding
out.
What I would like to talk about a little bit is the science
because that is what this session is about. And if I could just
have a second, I think that I can make clearer----
Senator Specter. Well, if you would be brief. We have two
more panels and it is 11:35.
Dr. Bigos. No problem. I chaired the HCPR guideline panel
for back problems. That was under the direction of the U.S.
Department of Health and Human Services. Because of the recent
Dopper decision at that time, we decided we had to do it not on
consensus or opinions but based on the actual data that was
available in the literature.
We went through a methodologic process of more than 10,000
abstracts and 4,600 studies putting them on paper so that you
could solve for x; better, no better, the same, with different
aspects.
The long and short of it is we also applied that within the
same process to the occupational literature as it relates to
back problems. The conclusions are that we found no evidence in
the reliable literature, not the literature that gives you a
hint that something might be there but the reliable literature
that lets you act.
Senator Specter. How did you determine what was reliable? A
little bit of subjective determination there?
Dr. Bigos. No, sir. I refer to Holly and Cummings who
basically have laid out there are certain studies that provide
you with evidence because you have looked at clues. There are
certain studies that only provide you with clues.
Retrospective cross-sectional studies provide you with
clues that have to be studied to see if the clues are correct.
Standing on top of a building and doing a 360 in Kansas would
lead you to the determination that the world is flat. But you
have to have a better measuring tool and it has to be subjected
to some scientific rigor.
Senator Specter. Dr. Bigos, do you disagree with what Dr.
Barondess said also, that there is, well, I know the answer to
this but I will ask it anyway, scientific basis for
intervention?
Dr. Bigos. I thought I saw that there was a call for more
research because we didn't have enough information to be able
to be specific, especially on the back pain----
Senator Specter. Did I quote you incorrectly, Dr.
Barondess? You said there was a scientific basis for
intervention?
Dr. Barondess. I did say that.
Dr. Bigos. I think that was for the upper extremity. I do
not think it was there for the back, was it?
Dr. Barondess. Yes, it was. In fact it is stronger for the
back.
Senator Specter. Dr. Barondess, when you say it is a 1
percent issue on the gross national product, I want to be sure
I have got my zeroes in order here, on a $10 trillion gross
domestic product, that would be $100 billion in losses?
Dr. Barondess. There have been estimates that high,
Senator. Actually, I wrestled with the zeroes myself and was
operating from a smaller estimate of the gross domestic product
when these figures were put together.
Senator Specter. What estimate were you working on?
Dr. Barondess. $5 trillion.
Senator Specter. $5 trillion. Looks like the tax cut is
going to have to be reduced then.
Dr. Barondess. That is the difference between a scientist
and an economist. We are here to help.
Senator Specter. This hearing I think has reached a new
milestone in very heavy competition on disagreement. The
economists go over the gross national product and the tax cut
and the surplus and cannot agree on anything. And
notwithstanding Dr. Punnett's testimony, I think witnesses
today have agreed on less.
I guess that is impossible but that is the way it seems to
me listening. Dr. Barondess, do you have a formula beyond your
conclusions on adding incremental risk and a scientific basis
for intervention as to what the intervention ought to be and
how you ought to tackle these various lines?
Dr. Barondess. Yes, sir. This is complex territory and the
committee's view is that multiple interventions need to be
applied when interventions are applied. They need to include
not alone efforts to ameliorate physical load but need to
involve also the workforce in their design, need to involve a
commitment from management, need to have something to do with
administrative alterations as well as mechanical alterations.
When Dr. Hadler says something about physical factors as
exclusive causes, that is not at all the conclusion the group
came to. And I agree with him that psychosocial factors are
extremely important. As I said earlier, humans are complex and
reactive on a number of levels.
Senator Specter. Thank you all very much. We are going to
move to Panel 4, Cost Benefits and Feasibility of Ergonomic
Programs. Mr. Dean Sparlin, Dr. Burton, Dr. Derebery, Mr. David
Alexander, Mr. Eric Frumin and Mr. Doug Bonacum.
Let me start with you, Mr. Sparlin, if we may. And thank
you for joining us and look forward to your testimony.
STATEMENT OF DEAN SPARLIN, ESQ., GIBSON, DUNN &
CRUTCHER, LLP
Mr. Sparlin. Thank you, Mr. Chairman. We are here today to
discuss economic issues with six panelists, none of whom is an
economist. I am a lawyer having represented clients in safety
and health matters during more than 14 years of practice.
The reason we do not have an economist here is that we have
not reached the point where one would be useful. So far we have
had a battle between big numbers and mind-numbingly huges ones.
OSHA told us last year that its ergonomic standard would
cost $4.5 billion per year. Employers countered with cost
estimates exceeding $100 billion. Any disagreement of that
magnitude has to be more than mathematics.
What we have here is a basic different vision between the
two sides. The key to resolving that difference is a clear
understanding of what a standard would entail, educated by
OSHA's own history of enforcing similar requirements.
With all due respect, I do not believe that testimonials
from ergonomists and safety and health personnel provide the
answer. These individuals work on ergonomics programs all the
time and they freely offer reports of their success.
The extent to which these claims represent hard facts as
opposed to salesmanship from people who make their living
promoting ergonomics is open to debate, but that debate is
largely academic.
The question is not what employers spend on ergonomics
under the status quo, but what they would be forced to spend
under a standard that would change the status quo.
My distinguished co-panelist, David Alexander, is an
articulate and passionate proponent of the mantra that
ergonomic controls are inexpensive. He has written numerous
books that promote the cost justification of ergonomics. And he
testified at the hearing that ergonomic interventions almost
always pay for themselves by ratios approaching 10 to 1.
His views and similar opinions from two other ergonomic
consultants were the sole basis for OSHA's cost estimate.
OSHA's role, however, is not to tell employers how to improve
productivity and save money but to protect safety and health.
If those two goals were as closely aligned as some like to
claim, then a standard would be unnecessary because employers
would be rushing to get their 10-to-1 pay backs.
But more than a decade of OSHA ergonomics activity pursued
on the advice of many of these same ergonomists, paints a very
different picture. There is a reason employers are almost
universally resisting OSHA regulation. And that reason is not
ignorance of economic benefits. It is the reality of what an
ergonomic standard would entail.
This stack of paper beside me, which is very high, is just
a partial compilation of more than 550 ergonomic citation
issued under the so-called General Duty Clause. Each of these
citations lists measures that OSHA believed to be necessary
abatements of alleged recognized hazards.
Over and over again, OSHA sought burdensome and costly job
controls such as the ones you see on the board that was just
posted. When employers argued that these citations should be
used as a measure to measure a final standards cost, OSHA could
not have backpedaled any faster.
OSHA claimed that its new standard would not necessarily be
enforced in the same way, even though the standard described
what was expected in language that was basically
indistinguishable from the citations. All the while, OSHA
refused to reveal exactly what its new enforcement policy would
be.
The agency also asserted that the abatements were merely
recommendations. But the one employer who actually litigated in
favor of a less expensive alternative was greeted with a parade
of OSHA experts insisting on the listed measures.
The reason OSHA is so afraid of its own history is that the
cost of these measures are an entirely different universe. Many
employers use these same citations to produce their own cost
estimates which added up to more than $179 billion. Taking into
account the employers who were not even represented, the
projection of more than $100 billion in total costs is not at
all unreasonable.
Now, if OSHA decides to try again, regardless of its chosen
approach, it will need to do a far better job of confronting
the most fundamental question in any cost analysis.
What does the standard actually require. In the last round,
OSHA's entire estimate of cost per job control was developed
before the proposed standard was even drafted. And that
estimate was never revisited even after major changes in the
final standard.
Now, I will not repeat OSHA's mistake of estimating a new
standards cost before I have seen the new standard. But I will
tell you that any future cost analysis must begin from a very
different base line.
prepared statement
OSHA should either use its own enforcement history as a
guide or should identify exactly what is different about the
new approach. If the agency continues to ignore its own
history, it will be doomed to repeat it, once again producing
cost estimates that seriously misrepresent reality.
[The statement follows:]
Prepared Statement of Dean Sparlin
Mr. Chairman and members of the Subcommittee: We are here today to
discuss the economics of an ergonomics standard with an engineer, a
health and safety director, a spine surgeon, and a lawyer. I am the
lawyer, having represented clients in occupational safety and health
matters, including ergonomics, during more than 14 years of practice
with Gibson, Dunn & Crutcher LLP.
The economic discussion to date has been characterized by a battle
between big numbers and mind-numbingly huge ones. OSHA told us last
year that its ergonomic standard would cost $4.5 billion per year but
would save approximately twice that amount. Employers countered with
analyses showing that costs could easily exceed $100 billion. When
there is a disagreement of that magnitude, it is safe to say that the
discrepancy is more than mathematical. There is a very basic difference
in vision between the two sides performing the calculations.
That, more than anything, explains why it is just as well that an
economist is not here to address these issues. Before anyone can opine
on the economic impact of a standard, there must be a clear
understanding as to what the standard would entail. The key to that
question lies not in economic theory, but in a practical understanding
of burdens that would be imposed in light of OSHA's own history of
enforcing similar requirements.
With all due respect, I do not believe that testimonials from
ergonomists and safety and health personnel provide an appropriate
perspective. It is true that these individuals work together on
ergonomics programs all the time, and they freely offer reports of
their successes. The extent to which these claims represent hard facts,
as opposed to salesmanship from people who make their living promoting
ergonomic interventions, is open to debate--but that debate is largely
academic. The question before us is not what employers spend on
ergonomics under the status quo, but what they would be forced to spend
under a standard that presumably would change the status quo.
My distinguished co-panelist, David Alexander, is an articulate and
passionate proponent of the mantra that ergonomic controls are
inexpensive. He has written numerous books on the subject, including
one entitled Selling Ergonomics To Management, which teaches readers
how to convince skeptical bosses to sign off on ergonomics programs. He
testified at the hearing that ergonomic interventions almost always pay
for themselves, by ratios that in his opinion can exceed 10 to 1.\1\ He
supported that view with descriptions of his experience advising
clients and anecdotes he has heard from colleagues in his profession.
His views, and similar opinions from just two other ergonomic
consultants, were the sole basis for OSHA's cost estimate.
---------------------------------------------------------------------------
\1\ Transcript, Mar. 20, 2000, at 2183.
---------------------------------------------------------------------------
It is not OSHA's role, however, to tell employers how to improve
productivity and save money. OSHA's role is to protect safety and
health. If the agency's safety and health vision were as closely
aligned with productivity as some like to claim, then a standard would
be unnecessary because employers would voluntarily rush to get their
10-to-1 paybacks. But more than a decade of OSHA ergonomics activity,
pursued on the advice of the same ergonomists who testified in favor of
a standard, paints a very different picture. There is a reason
employers are almost universally resisting OSHA regulation, and that
reason is not ignorance of the economic benefits. It is the reality of
what an ergonomics standard would entail.
The impressive stack of paper beside me is just a partial
compilation of more than 550 ergonomics citations that OSHA has issued
under the so-called ``general duty clause.'' Each of these citations
lists measures that OSHA believed to be necessary abatements of alleged
``recognized hazards.'' Most of these recommendations never show up on
ergonomists' lists of ``inexpensive'' controls. Over and over again,
OSHA compliance officers cited safety and health concerns as a
justification for slowing work pace, mandating rest breaks, adding
expensive hoists or automated devices, and micro-managing work
processes.
When employers argued during the rulemaking that these citations
should be used to measure a final standard's cost, OSHA could not have
backpedaled any faster. OSHA claimed that a standard would not
necessarily be enforced the same way, even though the standard
described what was expected of employers in language that was basically
indistinguishable from the citations. All the while, OSHA refused to
discuss exactly what its new enforcement policy would be. The agency
also asserted that the abatements were mere recommendations from which
employers could vary. But the one employer who actually litigated in
favor of a less expensive alternative approach in response to a general
duty clause citation--Pepperidge Farm--was greeted with a parade of
OSHA experts insisting that the agency's ``recommendations'' were
gospel.
The reason OSHA is so afraid of these general duty clause citations
is not hard to figure out. The costs they entail are in an entirely
different universe from OSHA's official estimate. Abatement measures
from these citations formed the essence of many employer estimates
submitted during the hearings, which added up to more than $179 billion
in anticipated costs. There is some overlap in the employer estimates
and some differences in their assumptions, but it is also true that a
very large portion of affected industry is not represented. It is not
at all unreasonable to expect, in light of this evidence, that costs
could exceed $100 billion--perhaps by a very wide margin.
Theoretically, OSHA could design a new standard or guideline--
assuming appropriate scientific support--that meaningfully departs from
past general duty clause excesses. This, however, will require more
than hollow assurances that enforcement will concentrate on inexpensive
remedies. Unfortunately, it is extraordinarily difficult to draft
concrete limitations that would enforceably confine control
obligations. Certainly the proposed standard's vague language does not
meet this objective. Nor does the final standard, whose ``action
triggers'' and ``hazard identification tools'' serve primarily to
underscore just how far OSHA expected employers to go in retooling
their workplaces.
If OSHA does decide to try again, regardless of its chosen
approach, it will need to do a far better job of confronting the most
fundamental question in any cost analysis: What does the standard
actually require? In the last round, OSHA's entire estimate of cost per
job control was developed before the proposed standard was drafted--by
individuals who afterwards could still not describe the standard's
provisions. The estimate was never revisited, even after major changes
in the final standard.
I will not repeat the mistake of estimating a new standard's cost
before I have seen it. But I will tell you that any future cost
analysis must begin from a different baseline. OSHA should either use
its own enforcement history as a guide or should identify exactly what
is different about the new approach. If the agency continues to ignore
its own history, it will be doomed to repeat it, once again producing
cost estimates that seriously misrepresent the true picture.
Senator Specter. Thank you very much, Mr. Sparlin. Mr.
David Alexander, certified professional ergonomist.
STATEMENT OF DAVID C. ALEXANDER, PRESIDENT, AUBURN
ENGINEERS, INC.
Mr. Alexander. Thank you very much. Good morning. I welcome
the opportunity to join the panel and share my experience on
ergonomics. My name is David Alexander. I am president of
Auburn Engineers, a leading applied ergonomics consulting
company.
My 25 years of private sector ergonomics experience spans a
range from small employers to the largest companies in the
world. I want to address the feasibility of ergonomic solutions
and the cost benefits of their interventions.
It has been widely stated that ergonomic problems are not
solvable or that the solutions are simply too expensive. That
information is wrong. With 25 years of professional experience,
I have yet to see a job that could not be improved with the
application of ergonomic principles.
I personally developed thousands of solutions to ergonomic
problems and my colleagues have told me of many more. The
solutions range from simple workplace changes to complex
factory redesigns. For window and door manufacture I was able
to reduce ergonomic risk factors by 90 percent while increasing
productivity by 300 percent. For chemical manufacture I was
able to reduce ergonomic risks by 80 percent while increasing
productivity by 50 percent. For an auto components manufacture
I reduced loss time by 80 percent while saving a million
dollars in operating cost. For a telecommunications company,
reduced lost time cases by 80 percent and demonstrated
productivity savings as high as 15 percent. These ergonomic
projects, while notable, are not uncommon. Similar results have
been reported by other practicing ergonomists.
The practice of ergonomics is not limited to experts,
however. Many organizations are using employee teams to resolve
problems and necessarily this drives the cost down rapidly.
Fifty percent of ergonomic problems in my opinion can be solved
locally using local resources and local workers and their
supervisors.
Many trade associations have developed solution databases
for ergonomic problems. They've shared these widely. I've
participated and worked with those in textiles, apparel, food
distribution, paper chemicals, petroleum, and I know other
industries have done the same.
These guidelines get passed from plant to plant. They
become more refined, they become more effective and they become
cheaper to implement, thus some of the cost from yesteryear do
not reflect the cost of tomorrow.
There are thousands and thousands of good examples of
interventions out there. OSHA has developed lists of these and
shared them, as have insurance companies and many universities.
In summary, I find that ergonomic problems are typically easy
to identify and rarely require sophisticated techniques to
resolve. I have a promotional poster, if I could put that up,
that illustrates a simple case of ergonomics. It involves some
visiting dignitaries we White House during the last Bush
administration as a story. Could you put the--it is a cartoon
poster, I am sorry.
As the story unfolds, several shorter dignitaries have
difficulty speaking from a podium adjusted for a much taller
President Bush. After several near falls, this team of
ergonauts uses our simple problem solving process to develop a
cost-effective solution to the problem. As the story
illustrates, ergonomics works.
Now, let me turn to the topic the cost benefits. Cost of a
dollar spent to implement solutions, benefits were the savings
that the organization achieves. The benefits are attained by
controlling worker injuries and saving the dollars currently
being lost from medical treatment, workers compensation, lost
time, replacement workers, overtime, lost production, reduced
quality.
All of these have benefits or a number of these have been
outlined by OSHA. But that is not the whole story. There are
substantial benefits which are not reflected by the OSHA cost
calculations. These are the business level improvements that
typically result from ergonomic projects. Mr. Sparlin referred
to these.
Here gains can be made that increase the operating
performance above baseline performance and these are
substantial, in some cases approaching ten times the cost. A
common problem with cost calculations is under-reporting.
People do not do a good job. Common problem with benefits is
under-reporting. We do not calculate those well. In one case in
the printing industry we were able to document ten times more
benefits than what had been initially perceived.
Project costs are frequently inflated. Overdesign is a
common problem with an emerging industry and that is what it is
with ergonomics. As we gain more experience, cost go down. I
also find that some industries have not modernized. They are
using out of date processes and unfortunately they lump the
cost of modernization along with the cost of ergonomic
compliance, thus grossly inflating prices.
prepared statement
When we look at ergonomics, we have to recognize that costs
will drop as experience goes on. I've chaired in a flight
ergonomics----
Senator Specter. Mr. Alexander, your time is up. If you
would summarize your full statement, it will be made a part of
the record.
Mr. Alexander. Thank you very much. Ergonomics works. Good
ergonomics is good business.
[The statement follows:]
Prepared Statement of David C. Alexander
credentials and qualifications
Good morning. My name is David Alexander. I have been practicing
ergonomics in the private sector for over a quarter of a century. I
hold two degrees in engineering, the second a Masters degree with a
specialty in ergonomics. I have continued my professional development
throughout my career with extensive academic work, short courses,
conferences, peer discussions, and professional exchanges.
I am licensed to practice engineering as a registered Professional
Engineer in Alabama and Tennessee, and have been for more than two
decades. Furthermore, I have authored many questions on ergonomics used
to test professional engineering candidates. The exam is required for
registration as a Professional Engineer.
I am a Certified Professional Ergonomist, and have been for many
years. For the past 4 years, I have served as an officer on and member
of the Board of Certification in Professional Ergonomics (BCPE). I
assist with the CPE test development process, and have worked to
increase the number of Certified Professional Ergonomists in the United
States and the world. I am currently Vice-President of BCPE.
My peers in the field of industrial ergonomics have recognized me
as one of their outstanding practitioners. I received the Ergonomics
Award from the IIE in 1986. I was awarded Fellow status in the
Institute of Industrial Engineers in 1990. I received the Industrial
Ergonomics Award from the Industrial Ergonomics Technical Group of the
Human Factors and Ergonomics Society in 1993. I am the only ergonomics
professional to be recognized by both of these two leading professional
societies.
I hold two patents for the design of ergonomics inventions. The
first is a revolutionary new tool handle design, and the second is for
an ergonomically designed piece of equipment used for decorating cakes
and other baked goods.
I speak routinely on ergonomics and its application in industry. I
have been invited to speak for groups in engineering, health care,
safety, health, legal and all other professions related to ergonomics.
My presentations have included invited keynote speeches as well of
papers, workshops and tutorials. I have taught thousands of people my
techniques and practices.
Currently, I am President of Auburn Engineers, Inc., an ergonomics
consulting company. I have many Fortune 100 companies as clients. My
staff and I provide a wide range of ergonomics services and have since
1988. During my tenure in ergonomics, I have worked with many
organizations, both large and small, representing many different
industries. I have worked with labor unions and with management, with
safety and health professionals, with engineers and health care
practitioners, with production workers and their supervision.
Prior to my work with Auburn Engineers, Inc., I was an engineer, an
ergonomist, and an ergonomics program manager for Eastman Kodak
Company, and performed hundreds of ergonomics projects in all facets of
their operations.
During my quarter century of professional ergonomics practice, I
have worked in many different industries. A listing of recent clients
includes: Chemicals, Forest Products, Petroleum, Food Production,
Health Care, Medical Equipment, Hospitality, Government, Food Service,
Electronics, Plastics, Aerospace, Paper and Pulp, Metals Refining,
Distribution and Delivery, Printing, Auto Assembly, Metal Processing,
Consumer Products, Telecommunications, Missiles and Space, Textiles,
Apparel, Appliances, Auto Parts, and Mining. Over the years, I have
worked with more industries, provided training for their staffs,
visited and toured others, and have spoken with ergonomists and
engineers from yet even more.
does ergonomics work?
During my years of experience with ergonomics, I have yet to find a
job that cannot be improved with the application of ergonomics
principles. I would like to share some examples of the outcomes of
ergonomics when it is applied in business:
--This company builds automotive equipment for a major auto assembly
manufacturer. It must provide components in a just-in-time
environment to an assembly plant a few miles away. We were
initially identified as a source of assistance by a state
agency whose mission it is to help state manufacturers that are
in distress or are having significant problems with
productivity, environment, safety or other major issues. This
company employs approximately 300 people at this site. When we
were first introduced to this company, they told us that their
injury rate was overwhelming, that their costs from these
injuries were approaching $1,000,000 annually, and that they
felt an OSHA citation was possible since OSHA was investigating
other issues at the plant. We worked collaboratively with them
to plan, then implement, an effective ergonomics program. The
work included identification of jobs with risks, development
and implementation of engineering and administrative controls,
training, and the use of job hazard analysis for all jobs.
Within a 6-month period, there was an 83-percent reduction in
workers compensation costs, and a drop in the OSHA recordable
rate from over 50 to less than 4. There was also a 100-percent
placement of workers with restrictions into normal production
jobs with no ``make work'' jobs being performed. This company
was recently awarded the PACE award in the automotive industry
for innovation management practice. So not only have they made
substantial gains in business performance, they have been
recognized by their peers for this accomplishment and the way
in which it was made.
--This company produces wood products in the mid-West, and had a
significant ergonomics problem. We helped reduce their
compensation costs from over $720,000 per year to $25,000 per
year, and dropped their injury rate from 180 per year to less
than 5 per year. We did this with a combination of engineering
and administrative controls, training, management support, and
other ergonomics program measures.
--This company produces pre-hung doors and windows. It was
experiencing excessive back injuries from manually handling the
doors and from poor work positions. We reviewed their jobs, and
developed a number of job enhancements including supported
tools, better work tables, guides and fixtures, and a new
conveyor line. When we were done, the result was a 300 percent
increase in productivity and a 90-percent reduction in
ergonomics risk. The plant was now able to produce 900 doors
rather than 300 doors per shift with no additional personnel.
--On a chemical bag filling operation, we were asked to provide
improvements for a bag filling and sealing operation. We did a
careful analysis and made recommendations that permitted a 50-
percent increase in productivity along with an 82-percent
reduction in ergonomics risk. The number of bags that could be
filled went from 960 per shift to 1,400. The changes included
an alternate method of moving bags on a conveyor, changing work
heights, and altering the methods of feeding bags into a heat
sealer.
I share these with you because they make the point I wish to leave
with you--Ergonomics works!
There are hundreds and thousands of successful ergonomics
interventions out there. Ergonomics works, and works well. These
successes range from simple changes to work methods to complete
reorganizations of factories and workplaces. Many of these successes
can be found by talking with practitioners in industry and business, or
by reviewing the many case studies found in the scientific and trade
press publications.
what are the tangible benefits to the application of ergonomics?
To answer this question, it is helpful to understand the types of
benefits one can expect from ergonomics applications. They fall into
several categories: avoided costs, and performance improvements.
Avoided costs begin with the avoidance of direct injury/illness
costs by controlling or eliminating the injury/illness. As this occurs,
then one also avoids the indirect costs of injury/illness such as
replacement workers, the manufacture of off-quality products, time for
the investigation of incidents, implementation of necessary corrective
actions, and so on. Essentially these are unplanned losses, or costs,
or expenses, which take profits away from the bottom line of the
organization.
Besides avoiding losses, there is a great opportunity to achieve
performance improvements. Performance improvements occur when
ergonomics improvements permit one to achieve breakthrough performance
that exceeds the current baseline. These improvements are most often
reflected as traditional business measurements such as enhanced
productivity, less downtime, product quality, delivery, fewer
bottlenecks, and so on. They may also include lower costs for workers'
training or employment as jobs become less stressful. The best way to
think of these items is that they improve upon your expected level of
operation and permit you to operate better than planned. The result is
increased profits to the business.
Ergonomics benefits are measured in at least 17 different ways,
according to my research, but one of the most common is benefit/cost
ratios. These calculate a ratio of the benefits associated with an
ergonomics project relative to the costs required for implementing the
project. The benefit/cost ratio should be greater than 1.0 for an
economical, value added project. The benefit/cost ratio can be impacted
in two ways: one, increase the level of benefits for the project, or,
two, decreases the costs associated with the project.
The benefits can be increased by identifying and reporting more
benefits (a common problem with cost justification is that economic
benefits are chronically underreported). The costs can be reduced by
lowering the cost of the project, perhaps by using administrative
controls or with less sophisticated engineering controls.
The cost of ergonomics projects is highly variable. Solutions range
from low cost administrative controls (work methods, job redesign) to
very expensive mechanical equipment. Often, for a single set of risk
factors, as many as 5-10 different solutions can be developed and
implemented. The choice of the solution has a great impact on the
overall cost of the project. For many projects that report high costs,
the problem is that an overly expensive solution has been chosen, when
in fact, a lower cost solution would work just as well.
In my work, I found that about half of the ergonomics projects cost
less than $500, and can be done on a standard work order without the
need for detailed justification. And only a third of the projects cost
more than $1,000. In other words, an ergonomics project is likely (two
times out of three) to cost less than $1,000, and usually can fit
within most operating budgets. Hugh budgets for the implementation of
widely expensive ergonomics program simply do not occur.
At the request of one of our clients, we examined these benefits
with the goal of developing ``multipliers'' which could be used to
determine the value of the benefits relative to workers compensation
costs. For ergonomics, the benefits multiplier was found to be from 0.5
to 2.0 for the ratio of direct to indirect costs. We also looked at the
benefits attained from improved performance, and found them to be very
large. This multiplier was found to range from 2 to 10 times the cost
of workers compensation.
One real opportunity, and one that is commonly overlooked, is the
savings that can occur from better design practices. We have measured
the costs associated with design for ergonomics, and find them to be a
highly attractive investment. In fact, this is how we characterize
these costs. They are an investment in the design, which should provide
a payback later on. The cost of design goes up substantially as the
project progresses. The difference between ``doing it right the first
time'' at the initial design stage and waiting until injuries occur
during normal operations, is ten-fold. The costs will be ten times
higher when retrofits are utilized rather than having ergonomics
designed in from the start. Similar figures have been reported by
others practitioners, especially those in the auto industry. What this
means is that costs for ergonomics interventions for current operations
cannot and should not be extrapolated into the future. When workplaces,
tools, equipment, vehicles, assembly lines, and factories are designed
properly from the start, the ergonomics costs should be one-tenth of
the current estimates.
trends in applied ergonomics
I founded the Applied Ergonomics Conference Series and last month
we held our 4th Annual Conference, with almost 800 people in
attendance. They represented industry and business from virtually every
employment sector, as well as organized labor, trade and professional
groups, and government. We heard 100 presentations on ergonomics
programs and interventions.
There is widespread use of ergonomics in the private sector for
both injury/illness control and business performance improvements.
During the four conferences I have chaired since 1998, we have had some
300 presentations on successful applications of ergonomics, dozens of
workshops and seminars, and keynote speakers from industry, labor and
government. Many of these presentations are documented in our printed
volumes of ergonomics case studies, and more recently in electronic
form on the internet.
And we have had 2,500 attendees representing virtually every state
in the union, our NAFTA partners Mexico and Canada, and a number of
European countries. The attendees represent 500 companies, universities
and Federal and State governments.
The Applied Ergonomics Conferences have been sponsored by a diverse
list of professional organizations and agencies including:
--Institute of Industrial Engineers
--Department of Labor Occupational Health & Safety Administration
--National Institute for Occupational Safety and Health
--American Association of Occupational Health Nurses
--American Industrial Hygiene Association
--American Society of Safety Engineers
--Association of Canadian Ergonomists/L'Association Canadienne
d'Ergonomie (ACE)
--Board of Certified Safety Professionals
--Board of Certification in Professional Ergonomics
--Ergonomic Assist Systems and Equipment--a product council of
Material Handling Industry of America
--International Labour Organization
--Risk and Insurance Management Society
--Society for Risk Analysis
--Society for Work Science
--Voluntary Protection Programs Participants' Association
At these conferences, I have been able to listen to many
presentations and to talk with dozens of participants about their on-
going work on ergonomics. I found the following trends:
--Ergonomics is being applied in increasingly diverse settings. We
have examples of ergonomics in food distribution, health care,
government, petroleum, meatpacking, retail, construction,
agriculture, distribution, and other industries.
--More and more people are involved with the application of
ergonomics. We have many examples of shop-floor teams, most
including supervision or staff, but some with just production
workers. There is normally involvement with nurses and health
care providers for root cause determination, and with
maintenance and engineering for equipment alteration.
--There are many examples of shop floor improvements leading to
injury/illness reduction and to productivity and quality
improvements. Most teams will report benefits for both safety
and health, and for productivity or quality.
--Training is becoming more commonplace and less burdensome. Some
teams develop skills with a few hours of training, and then are
ready to develop and implement successful ergonomics
improvements.
--There is extensive sharing of solution ideas. This sharing is
occurring within companies, within industries, and even across
industry sectors.
--There is a clear trend toward the use of design to prevent problems
rather than just to fix problems. Several major auto
manufacturer touted their successful work in the design of
manufacturing cells, production lines, and even in vehicle
design in order to prevent ergonomics injuries and illnesses
before they occur. A couple of important points about this:
--They use risk factors as their guide, not injuries. This
indicates a high level of maturity with the surveillance
and ergonomics problem identification part of their
programs.
--They do this design work for business reasons. Ergonomics is good
business, and it is economical to spend millions of dollars
in this way. For a new model change-over, the costs may run
into the millions of dollars, yet create savings equal to
10 times that number.
--They report that the majority of these changes result in other
positive business improvements like productivity (77
percent of the time), quality (50 percent of the time) and
reduced vehicle weight (10-15 percent of the time).
--Many who originally opposed ergonomics now support it! There are
many examples of companies who came to learn about ergonomics
from an OSHA citation, but who now tout its benefits.
Originally, they bemoaned ergonomics as a burden to their
business and unnecessary for the protection of their workers.
How time and experience can dramatically alter one's viewpoint.
if you go forward
I have worked with industry for many years, and I find that
ergonomics programs are more effective when they include the following:
--Involve employees in solving ergonomics problems. Ergonomics
solutions are not usually difficult to identify. In my
experience, 50 percent can be handled at the worker/supervisor
level, and most of the others are resolved with an in-plant
team.
--Use trade groups, sister plants and other organizations to both
identify and resolve ergonomics problems.
--Have a sound health care program and treat injuries both quickly
and with respect.
--Have management leadership on ergonomics, just like it provides
leadership on safety, health, production and quality issues.
--Provide training where necessary to ensure effective performance.
JHAs are necessary in modern industry.
--Prevent ergonomics problems by reviewing new jobs, tools, and
equipment.
--Review the ergonomics program to ensure its effectiveness.
There are clear differences between effective programs and
ineffective ones. Effective programs contain certain elements and work
in certain ways.
in closing
Finally, in closing, let me say that ergonomics is tool that is
already used in industry. It is not a new tool, it is not difficult to
use, and it is not burdensome. It is part of continuous improvement
programs used in many organizations to improve safety and health,
quality, productivity, and cost.
Thank you for your attention. I look forward to providing
additional clarification with your questions and on-going deliberation
on ergonomics.
Senator Specter. Thank you. We turn now to Mr. Eric Frumin,
director of Safety and Health, Union of Needle Trades,
Industrial and Textile Employees Mr. Frumin.
STATEMENT OF ERIC FRUMIN, DIRECTOR, SAFETY AND HEALTH,
UNION OF NEEDLE TRADES INDUSTRIAL AND
TEXTILE EMPLOYEES
Mr. Frumin. Good morning, Senator. First I just want to
submit for the record a slightly corrected version of the
written testimony I submitted.
Senator Specter. It will be made a part of the record in
full.
My name is Eric Frumin. I am the health and safety director
of UNITE. On behalf of our members in Pennsylvania and
Philadelphia and throughout the Nation, we very much appreciate
the opportunity to testify here today.
The arguments about costs and benefits have generated much
sound and fury and from some quarters like Mr. Alexander,
actual enlightenment. From other quarters, however, there's
been nothing but fury and active disinformation. Today UNITE is
confident in stating the following. First, the cost of these
injuries are huge to employers, workers and taxpayers alike.
Second, the requirements of the OSHA ergonomic standard are
eminently feasible. The potential cost of those requirements
are sensible in business investments, and the benefits of
ergonomic programs to workers, employers and society are
substantial.
The arguments you have heard today and before about the
feasibility, costs and benefits have degenerated into a virtual
warfare and as the saying goes, the first casualty of war is
the truth. It is been obstructed, the argument, has by what we
would call a big lie campaign orchestrated by the most rabid
opponents of reasonable worker safety rules who misled and
frightened employers large and small.
The Stanley company, as you know, is one of the nations
largest makers of tools. Their sales of ergonomically designed
tools depend heavily on employer confidence that ergonomics
works. But as one of their senior managers told Business Week
magazine, we're competing against ignorance. How much do these
injuries cost? As Dr. Barondess pointed out, between $45 and
$54 billion annually, about 1 percent of the gross domestic
product.
The cost of these injuries is the very reason why this
Congress passed the Occupational Safety and Health Act. But
actual industrial experience shows that ergonomics programs are
technically feasible and are cost-effective and I want to take
you, Senator, to Lewistown, Pennsylvania to the Leer
Corporation.
Repeatedly before both the Senate Labor Committee and the
OSHA rulemaking record local union officers have testified
about the OSHA citation at that plant, about the benefits of
the ergonomics program which the management implemented as a
result of that citation. That citation and the program the
employer implemented did exactly the same things that Mr.
Sparlin is listing on his chart here this morning and I am
curious why Mr. Sparlin hasn't pointed to the Leer Corporation.
That company came out strongly in support of OSHA enforcement
of the general duty clause and we know that that ergonomic
injuries in that plant have been seriously reduced to virtually
no disabling injuries anymore in that plant. And Senator, we
would invite you to come and visit that plant.
The auto parts industry is highly competitive. Good jobs
like this in central Pennsylvania are not easy to find. But the
management and these workers have nothing to fear from
ergonomics and everything to gain.
The OSHA rulemaking record is replete with examples like
this from large and small employers alike. The Xerox
Corporation submitted, Mr. Senator, a formal cost benefit
analysis to the OSHA rulemaking record. They spent $3.4 million
on the ergonomics program in 1999. They said the resulting
savings was $7 million in that year for avoided workers
compensation claims. These kinds of benefits are achievable
throughout the economy and OSHA reviewed hundreds of studies
and scientific evaluations and case studies which came to the
same conclusion.
Senator Specter. What company was the last one you referred
to?
Mr. Frumin. Xerox Corporation and that is in my prepared
statement.
Unfortunately, Senator, with rare exception it appears that
these and other well-meaning companies were not present at the
OSHA hearing. They did not show up to testify. You've heard
about the auto companies. Where were the Big Three companies at
the OSHA hearings. Where were the individual grocery chains,
where were the nursing homes? Seems like they were all in
hiding to avoid admitting the truth about their actual
investments in ergonomics and the returns that they enjoyed.
What OSHA did here instead largely with speculation about
possible compliance problems but the testimony of one
participant was most revealing, the United Parcel Service, the
single most active employer never showed up at the hearing to
testify. None of their managers came. Only later did OSHA
receive a corporate memo from UPS, UPS corporate memo, March
10th, the year 2000, from the corporate industrial engineering
department entitled Ergonomic Endeavors clearly identifies the
capital investments and operating investments they've made to
improve the ergonomics in their work force.
Never once did any of their representatives at that hearing
provide this kind of information to OSHA or identify the cost
that--the investments that UPS was making or the savings that
UPS was enjoying. Why? We cannot answer for them. Maybe they
can answer for themselves. But the real question to UPS and to
the other employers who have opposed this in the way that they
have, what are you now spending on it? Why don't you tell us
what the truth is, how much are you saving and why are you
making these investments.
prepared statement
Senator Specter. Mr. Frumin, your time has expired, your
full statement will be made a part of the record so if you
would now summarize, please.
Mr. Frumin. We have heard, and as Congress unfortunately
has heard, a figure of $120 billion as the cost of this
standard. We reject that as a total fabrication. We call upon
the Congress to look at the findings of previous OSHA
rulemaking such as the OTA, the Congressional Office of
Technology Assessment has shown OSHA's rulemakings to be
feasible, to be economically achievable and we urge the
Congress to immediately compel the Secretary to issue a new
standard forthwith. Thank you very much.
[The statement follows:]
Prepared Statement of Eric Frumin
Good morning. Mr. Chairman, members of the Committee, my name is
Eric Frumin. I am Health and Safety Director of the UNITE. I am also
the chairman of the Advisory Committee on Occupational Safety and
Health Statistics to the U.S. Bureau of Labor Statistics, and a member
of the Board of Scientific Counselors to NIOSH.
I am here to address several key questions regarding the OSHA
standard on ergonomics:
--the actual feasibility of the standard's requirements
--potential costs of those requirements, and
--likely benefits to employers, workers and society.
the first casualty of war is the truth
I want to state initially, however, that as with the so-called
debate about the underlying science of ergonomics, the discussion of
feasibility, costs and benefits has been obstructed by a Big Lie
campaign. This campaign was orchestrated by the most rabid opponents of
reasonable worker safety rules, who misled and frightened employers
large and small with their fabrications. This of course contributed to
the misinformation feeding the Congressional debate earlier this year,
and adds another unfortunate chapter at today's hearing.
This campaign of lies and distortion is truly shameful. Not only
has it irreparably harmed OSHA's ability to issue cost-effective
standards to prevent the biggest job-safety problem in the American
economy. It has also sowed confusion and fear of essential preventive
activities in the minds of America's managers and workers--the very
people who must understand clearly that ergonomics works, that
ergonomics both protects workers and saves money for employers and
workers alike.
actual industrial experience shows that ergonomics programs are
technically feasible and are cost-effective
On June 21, 1995, President Rick Treaster of UNITE Local Union 2400
from Lewistown, PA, testified before the Senate Committee on Labor and
Human Resources. About OSHA's intervention at his plant--the Masland
Co. auto carpet plant in (now owned by the Lear Corp.), which employs
200 workers. Mr. Treaster described in detail how OSHA's strict
enforcement of the general duty clause for ergonomic hazards
accomplished two things: first, it helped both the management and the
workers focus on real solutions to a serious safety problem. And
second, it prompted the company and the union to work together on new
joint efforts to improve wages, quality and productivity. At that
hearing, the management wrote to Chairman Kassebaum stressing its
strong support for strict enforcement of OSHA rules.
Attached to my testimony are the actual numbers of worker injuries
at the Lewistown, PA plant as of 1995.
During the OSHA rulemaking hearing on the proposed standard, Rick's
successor Greg Wakefield testified again about the continuing success
of the ergonomics program in the plant. Wakefield reported, as was
confirmed by the management, that serious ergonomically-related
injuries had been virtually eliminated in the plant due to an
aggressive comprehensive program which virtually mirrored the core
elements of the OSHA standard: worker education, early reporting, job
interventions and when needed intensive job and equipment redesign.
This resulted in substantially lower costs to the company, which
accompanied substantial boosts in productivity and quality. The auto
parts supply industry is highly competitive, and good jobs like these
in central Pennsylvania are not easy to find. But this management, and
these workers, have nothing to fear from ergonomics, and everything to
gain.
Mr. Chairman, as is revealed in both OSHA's final standard and the
testimony today of Dr. David Alexander, the OSHA rulemaking record is
replete with similar examples from large and small companies alike.
One company--Xerox Corp.--actually submitted a formal cost-benefit
analyses regarding its ergonomics program (Exh.#30-1963). According to
Xerox, their total 1999 ergonomics program investment of $3.4 million
yielded a
``. . . resulting benefit . . . of more than a $7 million reduction
in the annual cost of ergonomic-related workers compensation claims
from the 1992 peak.''
In other words, it shows that a corporate ergonomics program is a
net cost-savings measure when accounting even if one relies solely on
workers compensation costs. Moreover, such an analysis does not begin
to take into account the many other ergo-related cost types (such as
other disability and Human Resource costs, reduced productivity from
poor job design, limited quality due to bad job engineering, etc.).
A few other industry groups, such as the textile and apparel
industry associations, acknowledged that ergonomics programs were cost-
effective and a necessary part of a competitive business strategy in
today's economy.
Indeed, whenever anyone has looked seriously at actual industrial
experience with ergonomic principles and interventions, for those few
cases of failure or frustration there are many more cases of clear and
cost-effective success.
This includes the hundreds of detailed case studies reported
previously by corporate personnel, OSHA, NIOSH, labor unions and
ergonomics consultants. Others were performed directly by OSHA's expert
witnesses, including Dr. Alexander and others. These reports and
studies were done at the most recognizable names in American industry:
General Motors, Ford and Chrysler; Compaq Computer Co.; Allied Signal,
Coca-Cola, Kellogg Foods, Nabisco, Proctor and Gamble, Scott Paper, and
literally hundreds of other companies large and small.
Not surprisingly, in its Final Economic Analysis, OSHA specifically
cited 7 examples from the rulemaking record of well-documented, cost-
effective comprehensive ergonomics programs, including, Dow Chemical,
Consolidated Edison, US Defense Department, and Levi Strauss, in
addition to the company-specific programs in both large and small
businesses provided by three labor unions in the auto, food and apparel
sectors.
OSHA also cited in its Final Economic Analysis the large number of
both scientifically-designed evaluations of ergonomic interventions and
individual ``case studies'' on specific workplaces or occupations, some
of which clearly identified the employers in question.
Some of the same hundreds of companies which were also undoubtedly
included in the last-minute, biased survey by the Employment Policy
Foundation (EPF). This so-called claimed to indicate that the annual
costs to employers would approach $120 billion. Notwithstanding the
fact that this ridiculous estimate was submitted too late to be subject
to serious critical evaluation by OSHA or anyone else, it is
instructive how vastly different are the EPF estimates from those of
the real-world experiences of America's employers and workers.
Indeed, what surprised many observers at OSHA's hearing last year
was the utter absence of significant reports of actual ``bad'' employer
experience with ergonomics program, especially from the multiple
companies which had implemented ergonomics programs in the past.
Unfortunately, with rare exception, it appeared that these
otherwise well-meaning employers--companies which knew that ergonomics
works and saves money--were avoiding the OSHA hearing like the plague.
Where were the representatives from the Big Three auto companies
who had invested millions of dollars in ergonomics program far beyond
anything OSHA had required in its ergonomic citations?
Where were the individual grocery chains who had already spent
millions on improved checkstands?
Where were the nursing homes chains which are grappling with
unsupportable workers compensation costs and turnover rates because of
the epidemic of disabling back injuries among nurses aides?
They were all in hiding. We can only assume that they were avoiding
the prospect of embarrassing or frankly undermining their customers or
the know-nothing companies in the same industries. It seems they had to
avoid admitting the truth about their actual investments in ergonomics
activities, and about the returns they enjoyed on those investments
through the reduced costs for workers compensation or the improved
productivity of their operations.
Those skeptical or pessimistic estimates which OSHA did hear,
instead, was almost exclusively speculation about possible compliance
problems. Much of this speculation came from companies which had not
made serious efforts to prevent ergonomic injuries among their
employees. And given the campaign of fear which emanated from the
National Association of Manufacturers and Chamber of Commerce, it is
not surprising that the uninformed would attack ergonomics programs in
this way.
But the testimony of one participant was most revealing. Judging by
the number of lawyers present at any moment, the United Parcel Service
was the single most active participant in the entire rulemaking. They
initially requested an opportunity for over 20 witnesses to appear.
Most were supposedly independent medical personnel, but several UPS
managers were included. However, when UPS' turn came, almost all their
witnesses disappeared, including all participation by their corporate
managers.
Only later did OSHA receive--from the Teamsters union--the actual
evidence of UPS' views on the feasibility of ergonomics programs.
Attached to my testimony is the March 10, 2000 internal UPS memorandum
from the Corporate Industrial Engineering Department entitled
``Ergonomic Endeavors''. This memo clearly identifies substantial
capital and operating investments which UPS has made to implement an
ergonomics program throughout the company. It reveals that UPS has
invested significantly in new trucks, ergonomic tools for drivers, new
warehouse equipment, new computer software and hardware, new office
equipment and extensive training of management personnel.
This is the company which claims there is no science underlying
ergonomics, but that under the heading ``Comprehensive Self
Evaluation'' apparently has ``trained over 500 UPS people (including
some hourly) in ergonomic principles . . .''
This is the company that claims that ergonomics interventions do
not prevent lifting-related injuries, but that under the heading
``Ergonomics Awareness'' had run ``over 20 workshops . . . at
districts, regions across the country to convey importance of ergonomic
principles, job set-up and methods, and workplace design. . . .''
Mr. Chairman, UPS' lawyers attended the OSHA hearing virtually day,
and never once did they give OSHA any inkling of the extensive nature
of UPS' activities on ergonomics. Never once did they admit to UPS
having spent significant corporate resources to established an
ergonomics program. Never did they offer an actual UPS manager with the
authority to speak or answer questions about the company's engineering
investments in labor-saving equipment or the savings which UPS enjoyed
from that investment.
It is easy to understand why: because if UPS managers had revealed
officially the company's activities comparable to the very same
measures included in the proposed standard, OSHA or someone else might
have challenged them to say how UPS ever justified that investment.
What were the costs of the injuries that these investments were
designed to prevent? How large was the company's savings by the
avoidance of these costs? And how much more did the company save in
productivity improvements as a result of these investments?
$120 billion: a figure virtually from thin air
Mr. Chairman, those questions linger today even as the Employment
Policy Foundation's phony $120 billion cost figure continues to
reverberate around the Congress and throughout the media.
We completely reject this absurd, trumped-up fabrication.
Notwithstanding their complaints about OSHA's rush to judgment, EPF and
their presumptive allies at the NAM and UPS waited until March 2000 to
begin to collect data about employers' costs of compliance. They did
not make any of their data available until June 26, well after their
witnesses appeared at OSHA's actual hearing to answer questions. They
then reported the summary version of their actual economic estimates on
August 9, including their reference to their computer modeling which
generated the infamous $129.5 billion first-year cost figure.
This estimate purportedly relies on survey data from an unspecific
number of Fortune 500 companies with about 1.7 million workers in
nearly 20,000 separate establishments (averaging over 500
establishments per company).
However, despite that extensive direct line of communication with
the largest corporate entities in the entire world, the EPF survey did
not identify the actual compliance costs for a single specific high-
risk job or operation. Not for a single truck driver, or grocery
warehouse or retail checkstand, or nursing home, or paint booth, or
parts assembler.
Furthermore, their survey itself was not submitted for the record,
only portions of it dealing with the employers' estimates of time
allotments. And the actual methodology for the conduct of the survey
was never revealed--only the summary results.
(At the same time, they acknowledged that the benefits would be
significant--albeit less than OSHA estimated in the proposed rule. But
they failed utterly to provide any accounting of the derivation of the
benefits, nor to report the experiences of individual employers
regarding the returns on ergonomic investments which such employers
have enjoyed.)
We may contrast this with the extensive and detailed examination
which OSHA gave to specific industry sectors in both the proposed and
final standards, as required by the OSH Act and the Regulatory
Flexibility Act. OSHA made multiple analyses to confirm the legitimacy
of its approach. OSHA ultimately derived a cost-estimate which began
with job-specific estimates covering nearly half the reported MSD's in
the entire economy. In addition, OSHA dealt specifically in the final
standard with the criticisms of its opponents, including UPS and EPF,
regarding OSHA's cost estimates for individual jobs or operations.
All of this analysis would be reviewable by the Court of Appeals.
As in the past, OSHA's opponents would have detailed opportunities to
challenge OSHA's methods and conclusions, and request a stay of the
proceedings if needed.
But OSHA's opponents had no sincere interest in legitimate analysis
or discussion. Their only interest, it is now evident, was to quash any
real evaluation of the facts about workplace injury or effective job
safety investments, and destroy OSHA's ability to ever regulate these
hazards.
history of industry misrepresentations about costs
But this is by no means the first time that an industry coalition
or trade association has sought to undermine the basic functioning of
the Occupational Safety and Health Act by vastly overestimating the
potential technological or economic problems of compliance with a
proposed OSHA standard. Virtually every time that OSHA has proposed to
substantially improve worker, the affected industries have cried wolf
about the supposed costs, and threatened to close up shop. And time
after time, the actual costs have been within OSHA's estimate--or
indeed far less.
In 1995, the Congressional Office of Technology Assessment reviewed
this sordid history of industry obstructionism, and tried to identify
the actual costs. OTA, no captive of the labor unions or environmental
activists, concluded, among other things:
1. The agency's findings and estimates on hazard control options
and regulatory impacts are often the subject of vigorous review and
challenge by stakeholders and various experts on all sides of
rulemaking issues. But this reaction does not generally indicate
underlying agency analytical neglect. The agency's rulemakings are
often lightning rods for controversy and are conducted in a politically
polarized setting.
2. The agency's findings and estimates on hazard has generally
performed this task with workable accuracy--that is, standards
determined by OSHA to be ``feasible'' in the course of its analytical
deliberations have usually proved to be so when industries took the
necessary steps to comply. Nonetheless, the agency's demonstrations of
feasibility are often based on conservative assumptions about what
compliance responses will predominate across affected industries. As a
result, there are often sizable disparities between OSHA's rulemaking
projections of control technology adoption patterns, compliance
spending, and other economic impacts, and what actually happens when
affected industries respond to an enacted standard. In a good number of
the cases that OTA examined, the actual compliance response that was
observed included advanced or innovative control measures that had not
been emphasized in the rulemaking analyses, and the actual cost burden
proved to be considerably less than what OSHA had estimated.
3. . . . OSHA's rulemakings are not generally imposing unworkable
compliance burden on industry. In six of the eight cases considered
industry stakeholders and their representatives argued in the course of
the rulemaking (modestly to vigorously, depending on the case) that
compliance would pose unworkable problems. . . .
For the most part, the post-promulgation reality observed in this
project's case study standards proved much the opposite of these
representations. [footnote omitted] In almost all these cases . . .,
the industries that were most affected achieved compliance
straightforwardly, and largely avoided the destructive economic effects
invoked by their rulemaking arguments. Very few companies left the
industry chiefly because of the new compliance requirements. And, in a
good many of the cases, the actual cost burden of compliance proved
considerably less than OSHA's final estimate--about one-quarter the
estimate in Vinyl Chloride, one-third in Cotton Dust, and one-half in
Formaldehyde (metal foundries). Furthermore, in half of the eight cases
examined, the standard stimulated changes in the production technology
of affected industries that yielded benefits beyond a means for health
and safety hazard compliance.
In Vinyl Chloride, several of the principal industry members
capitalized on the altered business and regulatory setting to
commercialize innovative processes for polyvinyl chloride
polymerization, which enhanced manufacturing productivity, better
rationalization of material inputs, largely eliminated the need for
manual reactor cleaning (a prime source of high exposures for the
workforce), and provided a new source of income to the technology's
developers through licensing arrangements.
In Cotton Dust, OSHA's mandate for greater dust control, combined
with a strong need for more competitive production capacity, drove much
of the textile industry to accelerate investments in modern production
equipment--this modernization yielded improvements in manufacturing
productivity and product quality while providing a more cost-effective
means to bring dust levels within the terms of compliance.
Other aspects of this persistent problem are described in the
attached analysis of the OTA report from the New York Times.
We have witnessed this year probably the most catastrophic example
of this unscrupulous behavior. It remains up to the Congress heed the
conclusions of the Office of Technology Assessment, and to set the
record straight: OSHA's work has benefited the American people, and
deserves our support even in the face of an hysterical political
juggernaut like that opposed to the ergonomics standard. To do
otherwise is to tell America's workers that they are simply expendable.
cost of injuries
American workers are currently paying the price for these injuries,
and the costs to them, their employers and society are immense. The
recent review by the National Academy of Sciences concluded that the
total bill to the U.S. economy for Workers Compensation and other
medical/disability costs, and for lost productivity, amounts to between
$45 and $54 billion annually, or about 1 percent of our Gross Domestic
Product. This is an immense sum.
The Liberty Mutual company, the nation's largest workers
compensation insurance carrier, has repeatedly called attention to the
high costs of back injuries and other disabilities related to ergonomic
hazards. Their data on disability costs figured prominently in OSHA's
estimate that each disabling injury prevented by a reasonable
ergonomics program would yield injury-related cost savings averaging
$22,000.
Who is paying these costs now? Billions of dollars of these costs
are now paid by employers. Many of these employers should know better--
and invest in the simple equipment to prevent injuries. But they
unfortunately are not willing to make even these small investments for
worker safety and require an OSHA standard to simply get their
attention.
Other costs--often great than employers pay--are paid by workers
and their families. The daily pain and agony of back pain or carpal
tunnel syndrome. The inability to pick up a child or a frying pan. The
depression from severe disability and the fear of family economic
survival.
Other costs are paid by the taxpayer, as workers tossed overboard
are washed ashore as recipients of Social Security Disability benefits
and Medicaid.
In addition there are substantial benefits to employer from
ergonomic investments that improve productivity. Whether it is a simple
shelf or conveyor in a warehouse, or redesigning an entire assembly
line to reduce lifting of parts and tools, the improvements in
productivity which OSHA identified during the rulemaking hearing are
common, sensible and often quite impressive.
conclusion
These costs--and benefits--are immense. They are the very reasons
that the Congress passed the OSHAct in the first place.
The benefits are achievable, and are exactly what's needed to
preserve real jobs for working families in a period when so many
working families are left behind.
We urge the Congress to immediately restore OSHA's authority to
adopt an Ergonomics Program Standard, and to compel OSHA to issue such
a standard with all deliberate speed.
UNION OF NEEDLE TRADES INDUSTRIAL AND TEXTILE EMPLOYEES, DISABLING WORKER INJURIES AND ILLNESSES, 1987-1994,
LEAR CORP. (FORMERLY MASLAND INDUSTRIES INC.), LEWISTOWN, PA
----------------------------------------------------------------------------------------------------------------
Injuries Repetitive motion cases
---------------------------------------------------
Number Lost days Number Lost days
----------------------------------------------------------------------------------------------------------------
Pre-OSHA inspection:
1987.................................................... 76 460 37 462
1988.................................................... 110 955 31 608
1989.................................................... 49 887 35 527
Post-OSHA:
1990.................................................... 48 473 17 324
1991.................................................... 21 33 15 206
1992.................................................... 20 202 9 1
1993.................................................... 29 209 9 188
1994.................................................... 29 64 19 75
----------------------------------------------------------------------------------------------------------------
Senator Specter. Thank you. Mr. Doug Bonacum, director of
Patient Safety, Kaiser Permanente.
STATEMENT OF DOUG BONACUM, DIRECTOR, PATIENT SAFETY,
KAISER PERMANENTE
Mr. Bonacum. Thank you for the opportunity to testify here
today. I am the director of Patient Safety and Environmental
Safety for Kaiser Permanente, the largest private nonprofit
provider of health care services in the United States, with
approximately 8.2 million members in 9 States and the District
of Columbia.
Our mission is to provide high quality health care services
to improve the health status of our members in the communities
we serve. In support of this mission, the organization strives
to provide a safe, healthy and supportive work environment for
our employees, our physicians and our members. We believe an
important component of this objective is to identify, evaluate
and mitigate ergonomic risk factors that challenge our work
force.
I am here today to discuss strategies for minimizing and
preventing work injuries and illnesses related to risks
associated with musculoskeletal disorder and will highlight one
particular ergonomics-based application of this approach at
Kaiser Permanente. Kaiser Permanente's occupational injure and
illness reduction strategy is based upon a multifaceted
approach that begins far upstream of worker injury illness and
ends with the safe and efficient return to work program.
Our focus is on engineering controls, safe work practices
and injury response and recovery in that order while our
current OSHA recordable case rate is about average for our
industry, we are confident that the program elements we have
put in place will measurably improve our safety record.
We are initially focusing our energies in two primary
areas, housekeeping and patient handling. For injuries
occurring during 2000 alone this constituted approximately 30
percent of our workers compensation cases and costs. The
majority of injuries in both areas result from overexertion.
As our nursing work force is aging with the demand for new
nurses exceeding the current supply, our inpatient population
is becoming sicker and often heavier. As a result, we are
particularly concerned about the back safety of our nursing
staff. For this reason we have begun implementing an aggressive
back safety program, targeted patient handling, that is now in
its second year of a 2 year project to demonstrate the efficacy
of patient handling equipment, training and monitoring in
significantly reducing back injuries to our patient care staff.
There are, of course, numerous reasons for lifting and
transferring patients in the course of care. For example,
ambulating a patient after surgery may be a significant part of
the healing and recovery process or lifting a wheelchair
dependent patient to an exam table provides the caregiver with
an appropriate opportunity to facilitate a more through and
complete physical examination. Without the right equipment,
training and patient--without the right equipment and training,
patient repositioning, lifting and transfer tasks that seem to
go without hitch on TV can result in musculoskeletal strains
resulting in painful, life-changing injuries to our precious
work force.
With 27 of our 29 owned and operated hospitals located in
the State of California, we are currently focusing our patient
handling ergonomic interventions there first. At the core of
this program is patient handling equipment.
The patient handling equipment we have selected includes
vertical lifts, pivot transfer aids, special patient chairs and
lateral transfer devices. The selection process was performed
with input and hands on evaluation from employee user groups,
expert advice from consultants and discussions with other
health care organizations using similar equipment.
There are three primary methods for utilizing the patient
handling equipment with the most preferred option being full
time staff dedicated to the use of the equipment and associated
tasks. The dedicated patient handling lift team is recruited,
trained and assigned accountability for identified high-risk
tasks. On average, there may be two patient lift teams per 250
hospital beds. They generally conduct lifts in pairs and
depending upon the hospital's accident experience and
resources, may be staffed during one shift or around the clock.
Prior to joining Kaiser Permanente the individual leading
our program implemented a patient handling lift team in another
health system in California and achieved a reduction of back
injuries of over 80 percent during a 3 year period. We are
looking to do the same.
Employee participation has taken place on all back safety
interventions and many are sponsored by local management
partnership committees that typically include employee
representation. Kaiser Permanente's labor management
partnership is about engaging our work force from problem
solving through strategic planning in order to attain our
mission of providing high quality care to our members. In
short, worker safety is part and parcel to our partnership.
While the primary focus of our early efforts on back safety
have been on the worker, we recognize there are linkages to and
synergies with other critical performance areas including
patient safety, facilitating adequate path for our members with
disabilities and compliance with state OSHA requirements.
prepared statement
In other words, we feel the appropriate application of
ergonomic interventions at Kaiser Permanente will have far-
reaching, positive impact well beyond our primary goal of
ensuring worker safety. For Kaiser Permanente, a healthy work
force operating in a safe workplace is part of our commitment
to providing high quality affordable care. Thank you.
[The statement follows:]
Prepared Statement of Doug Bonacum
Chairman Specter and Committee Members: Thank you for the
opportunity to testify here today on the very important issue of
ergonomics. I am Doug Bonacum, the National Director of Patient Safety
and Environmental Health and Safety for Kaiser Permanente in Oakland,
California. I would like to take a few minutes to discuss some of the
efforts Kaiser Permanente is undertaking to improve ergonomics in our
workplaces.
kaiser permanente
The Kaiser Permanente Medical Care Program is a predominantly
prepaid, group practice health maintenance organization that is
committed to providing excellence in both quality of care and quality
of service. In each region in which it operates, Kaiser Permanente is
composed of three closely cooperating organizations: Kaiser Foundation
Health Plan, Inc., a California nonprofit corporation that is a
federally qualified HMO; or one of its regional health plan
subsidiaries; Kaiser Foundation Hospitals, a California public benefit
corporation, which provides or arranges for hospital services to our
members; and the Permanente Medical Groups, which are multi-specialty
physician group practices organized as partnerships or professional
corporations and which provide or arrange for all medical services our
members require.
Founded in 1945, Kaiser Permanente is the largest private, non-
profit provider of health care services in the United States, with
approximately 8.2 million members in 9 states and the District of
Columbia. We operate 29 acute care medical centers and 423 medical
offices in which we employ approximately 90,000 people. More than
11,000 physicians practice within the Permanente Medical Groups.
The mission of Kaiser Permanente is to provide affordable, high
quality health care services to improve the health status of our
members and the communities we serve. In support of this mission, the
organization strives to provide a safe, healthy, and supportive work
environment for our employees, physicians, and members. We believe an
important component of this objective is to identify, evaluate, and
mitigate ergonomic risk factors that challenge our workforce.
addressing ergonomic issues in the health care workplace
While significant media attention has more recently been focused on
patient safety, the healthcare industry is not without its fair share
of worker health and safety risks as well. These include potential
exposures to bloodborne pathogens and infectious diseases, high-level
disinfectants, sterilants, anesthetic gases, and laboratory chemicals,
and occupational injury and illness from such activities as patient
lifting and transport. I am here today to discuss strategies for
minimizing and preventing worker injuries and illnesses related to
risks associated with musculoskeletal disorders, and will highlight one
particular ergonomics-based application of this approach at Kaiser
Permanente.
For the purposes of this discussion, ergonomics means the practice
of adapting the physical environment and implementing safe work
practices consistent with a human being's capabilities and limitations,
resulting in optimal individual health and productivity. While the
overall goal of an ergonomics program should be to ultimately eliminate
occupational injuries and illnesses caused by ergonomic stressors, our
guiding principles include trying to put the least amount of stress on
the body's framework, requiring the least amount of physical work by
tissues and joints to maintain safe postures and positions while
providing high quality care. We look to minimize or prevent the
cumulative application of biomechanical stress to tissues and joints by
identifying and controlling the following risks: (a) The frequency of
specific physical motion or exertion known or believed to potentially
cause harm, (b) The force or physical exertion /pressure applied to
vulnerable parts of the body during specific motions, and (c) The
duration or length of period in which an activity occurs that leads to
the risk of an ergonomic injury.
Kaiser Permanente's occupational injury and illness reduction
strategy is based upon a multi-faceted approach that begins far
upstream of worker injury or illness, and ends, in the event of an
injury or illness despite best efforts to avoid it, with a safe and
efficient return-to-work program. It is based on a safety hierarchy
that addresses risk in the following fashion: (1) Eliminate, (2)
Mitigate, (3) Administrate, (4) Educate, and when necessary, (5)
Remediate. In other words, the focus is on engineering controls, safe
work practices, and injury response and recovery, in that order. While
our current OSHA Recordable Case Rate is about average for our
industry, we are confident that the program elements we have put in
place will measurably improve our safety record. These elements
include:
(1) Mandatory design and construction standards for casework,
furnishings, and the work environment, as well as mandatory purchasing
requirements for ergonomic accessories. Multi-functional teams develop
these standards with representatives for our physicians, nursing staff,
other caregivers, and administrators. Because Kaiser Permanente is an
Integrated Delivery System, we can ensure that each of our newly
constructed or renovated facilities is designed with adherence to our
internal standards, and products and materials are purchased from
contracts that include ergonomically correct equipment.
(2) Training and education efforts that include new employee
orientation, an on-line refresher course addressing basic ergonomic
principles and procedures, and task or job specific training for high
risk areas (e.g., patient handling).
(3) The application of on-the-job hazard recognition and control
principles principally applied to patient handling and housekeeping
operations, as well as repetitive laboratory and back-office
procedures.
(4) An active medical management program that has been instrumental
in getting injured employees back to the workforce in a safe and
efficient manner.
(5) Performance monitoring and internal reporting systems based
upon workers' compensation case rates, as well as program evaluation to
assess and report compliance with internal standards, best management
practices, and various State regulations.
We are initially focusing our energies in two primary areas:
Housekeeping and Patient Handling. For injuries occurring during 2000,
these two areas alone constituted approximately 30 percent of our
workers' compensation cases and costs. The majority of injuries in both
areas result from overexertion. As our nursing workforce is aging, with
the demand for new nurses exceeding the current supply, our in-patient
population is becoming sicker and often heavier. As a result, we are
particularly concerned about the back safety of our nursing staff. For
this reason, we have begun implementing an aggressive back safety
program targeted at patient handling.
We are currently in the second year of a two-year project to
demonstrate the efficacy of patient handling equipment, training, and
monitoring in significantly reducing back injuries to our patient care
staff. We have benchmarked with other healthcare organizations and
partnered with a recognized industry expert in formulating our approach
and expect to achieve significant reductions of back injuries in
targeted areas well in excess of 50 percent.
Anyone who watches one or more of the popular television hospital
dramas will often see a team of people manually, and seemingly,
comfortably transferring a patient from gurney to bed or bed to
wheelchair, for example. These types of lifts or transfers occur
repeatedly in the course of diagnosis, treatment, and recovery, both in
the hospital environment, and across the continuum of care.
Unfortunately, patient handling is seldom comfortable and often done
without the aid of a large team of people. This has resulted in
significant back issues for nursing workforces.
There are numerous reasons for lifting and transferring patients in
the course of care. For example, ambulating a patient after surgery may
be a significant part of the healing and recovery process; transferring
a patient from gurney to procedure, exam or radiology table may be
required to ensure the patient receives the appropriate examination or
follow-up care; and aiding patients in unexpected situations such as
assisting a patient who has fallen to the floor. Lifting a temporarily
disabled or disabled wheelchair-dependent patient from a wheelchair to
an exam table provides the caregiver with an opportunity to facilitate
a more thorough and complete physical examination. Without appropriate
equipment, training, and feedback, these patient repositioning, lifting
and transfer tasks that go without hitch on TV, can result in
musculoskeletal strains, resulting in painful, life changing injuries
to the workforce.
With 27 of our 29 owned and operated hospitals located in the State
of California, we are focusing our patient handling ergonomic
interventions here first. We are piloting an approach which provides
flexibility in individual hospital implementation, but, at its core,
consists of the following four main elements:
--The identification, selection, and implementation of lift equipment
to take strain off the backs and shoulders of our workforce and
place it instead on the mechanical arms of engineering
controls.
--Development of expected practices and protocols for utilizing the
equipment and lifting patients.
--Training and education for the affected work force on basic
ergonomic principles, the mechanics of safe lifting,
utilization of the equipment, and the application of safe work-
practices.
--Program monitoring, modification, and back-injury reduction
tracking and reporting.
The patient handling equipment we have selected includes vertical
lifts, pivot transfer aids, special patient chairs, and lateral
transfer devices. The selection process was performed with input and
hands-on evaluation from employee user groups, expert advice from
consultants, and discussions with other healthcare organizations using
similar equipment. The patient care team develops consensus on the
application and utilization of the lift equipment including who will
use the equipment, how to use it, and when it will be used.
There are three primary methods for utilizing the patient handling
equipment, including: (1) Training current staff how and when to use
the equipment, (2) Designating select staff members to use the
equipment as patient handling specialists, or (3) Hiring full time
staff dedicated to the use of the patient handling equipment and
associated tasks (preferred strategy). The dedicated staff patient
handling ``lift-team'' is recruited, trained, and assigned
accountability for identified high-risk tasks. On average, there may be
2 patient lift team members per 250 hospital beds for any eight hours
of hospital coverage. They generally conduct lifts in pairs, and,
depending upon the hospital's accident experience and resources, may be
staffed during one shift or around-the-clock. Prior to joining Kaiser
Permanente, the individual leading our program implemented a patient
handling lift-team in another health system in California and achieved
a reduction of back injuries of over 80 percent during a 3 year period.
We are looking to do the same at Kaiser Permanente. The initial
estimated cost for purchasing the lift equipment averages approximately
$100,000 per center. At an estimated average cost of $20,000 per back
injury, even the strictly financial return on investment from the
appropriate selection and implementation of lift equipment can be as
short as one year.
To date, we have fully implemented patient handling projects in 9
medical centers, three of which are piloting the lift team
intervention, and we are on track to have full implementation in the
remaining medical centers by year-end. We will monitor the Program's
success through quarterly workers' compensation case rate reports, as
well as using an internal audit program to ensure compliance with
relevant Kaiser Permanente Standards and Federal and State regulatory
requirements.
Employee participation has taken place on all back-safety
interventions and many are sponsored by local Labor-Management
Partnership committees or Local Safety Committees that typically
include employee representation. Kaiser Permanente's Labor Management
Partnership is about engaging our workforce, from problem solving
through strategic planning, in order to attain our mission of providing
high quality care to our members. The objective of the Partnership is
to create a culture of consultation within the organization, in which
labor and management routinely collaborate to address issues of
operations, the quality of patient care, and the quality of work life
at Kaiser Permanente. In short, worker safety is part and parcel to our
Partnership.
While the primary focus of our early efforts on back safety have
been on the worker, we recognize there are linkages to and synergies
with other critical performance areas including Patient Safety,
facilitating adequate care for our members with disabilities, and
complying with California OSHA requirements for reducing occupational
injuries and illnesses. An example of the Patient Safety connection is
recognition that a member who is routinely and safely ambulated after
surgery has potentially less chance of falling, acquiring bed sores,
contracting a respiratory illness, or suffering an increased hospital
length of stay due to slower than expected recovery. The linkage to
providing appropriate care for our disabled community is as simple as
ensuring that a wheel chair bound patient can be safely transferred
from their wheel chair to an exam table for a complete and thorough
examination. In other words, we feel the appropriate application of
ergonomic interventions at Kaiser Permanente will have far reaching,
positive impact well beyond our primary goal of ensuring worker safety.
In short, a healthy workforce, operating in a safe workplace is part of
our commitment to provide easier access and delivering high quality,
affordable care.
Thank you for your time. I would be happy to answer any questions
you may have.
Senator Specter. Thank you, Mr. Bonacum. I had hoped that
Secretary Chao will stay for the entire hearing. She was unable
to do that. I know she has representatives here and I think
that there have been some illustrations here where employers
and employees have come very close and I am impressed with what
you said, Mr. Bonacum, as to what Kaiser Permanente has done.
And the testimony of the auto industry is also a model where
they are getting pretty close. And I think what Mr. Sparlin
said about the OSHA bureaucratic response is understandable
too. May not be so much the regulations, but the way OSHA
enforces them or interprets them which really requires a lot
more supervision so that you get to the important spots but you
do not create a climate where there's so much resistance
because of excesses.
So Mr. Fruman's testimony I think is important in
identifying companies which have gone along a way and I'd be
interested to find out why some of those companies didn't come
in to testify.
I have a lot of questions but it is now past noon and we
have another panel, so I am going to thank you all very much.
Mr. Sparlin. Mr. Chairman, before we adjourn it is
unfortunate that this forum was used as a means to impugn this
particular company, UPS, but may I be afforded an opportunity
to briefly respond.
Senator Specter. Sure. I do not know that we've impugned
them, but go ahead.
Mr. Sparlin. Well, there was an accusation about UPS and--
--
Senator Specter. Well, it was said they didn't come in to
testify.
Mr. Sparlin. Well, it was said that they--I believe it was
a little stronger, but the record will speak for itself.
Senator Specter. That is okay, if you want to reply, go
ahead.
Mr. Sparlin. Yes. UPS has never made a secret from anyone
that it is engaged in ergonomic programs and having a great
deal of success. But what Mr. Frumin and many others seem to
fail to appreciate is that any time you use the E word, it
doesn't necessarily mean the same thing.
UPS does not vigorously oppose an ergonomic standard simply
because it likes to pay lawyers to engage in a big battle. It
is opposing the ergonomic standard because it does not believe,
and I believe your observations are very much on point, that
the direction that OSHA is taking is a proper one and moreover,
it is very concerned that this is not frankly something that
can be articulated. I mean, you've articulated the goals as to
what we might want to accomplish.
But frankly you have two paradigms. One is the proposed
standard where OSHA basically went to employers and said if you
find a problem, go forth and fix it and they didn't give much
guidance. And so employers didn't know what to do. So they
complained about that and OSHA gave us a final standard which
they didn't give us a right to comment on which gave eight
specific hazard identification tools.
Senator Specter. They did not give you a right to comment--
--
Mr. Sparlin. On the final standard, that is correct. And
the problem there was those particular tools lacked scientific
support, were inconsistent with one another, and frankly did
not achieve the goal of backing away from the excesses that we
believe are apparent here. So that is the problem we're faced
with and frankly, it is a very difficult challenge but from the
economic perspective what we need to do is get away from just
the notion of coming up with anecdotes and, you know, anything
that we can label ergonomic we make claims about it and we put
a price tag on and even as we change the standard we do not
change the price tag. We have got to be very specific about
what it is we are expecting from employers, what we expect to
gain from it, what we expect it to cost, be honest about doing
the calculations and do them very carefully and with hard data
support.
Senator Specter. Well, Mr. Sparlin, you made some valid
points. It may be that the input from a lot of companies which
have had success will be very helpful in formulating a standard
and then it may be that the application and supervision of the
standard really ought to have representatives of all sides,
business and labor, so that you do not have just OSHA doing it.
Too often, and this is not a reflection on the Federal work
force, the agencies become excessive in their application.
Happens all the time. Lots of lawsuits go up on the
administrative process. Maybe we need some umpires from
business, from labor, to take a look at it and try to put some
balance in the implementation of the regulations.
Mr. Frumin, I see you moving forward in your chair. Having
had a reply to you, would you like a surrebuttal?
Mr. Frumin. I would appreciate the opportunity, Senator.
Senator Specter. Go ahead.
Mr. Frumin. Mr. Sparlin's comments regarding a good faith
effort by UPS flies in the face of their lack of participation
in any constructive form in this process. We did not, OSHA did
not, receive the benefit of UPS's detailed cost analysis of
their own ergonomics program during the rulemaking hearing or
during the years and years and years of earlier discussions,
debates, stakeholder meetings, committee meetings, et cetera,
et cetera.
What are the actual costs of the employers who have
implemented ergonomics programs? OSHA begged industry and their
representatives to provide that information repeatedly since
1991 and companies like UPS and others preferred to sit on the
sidelines, withhold their real world information and shoot at
OSHA for doing the wrong thing. Other companies which had spent
the money, most of them unfortunately did not provide that
information.
Senator Specter. Mr. Frumin, the subcommittees will make an
inquiry on the UPS, what you've suggested. If you have other
companies, let me know.
Mr. Frumin. Well, we invite you to come to Lewistown and
meet one.
Senator Specter. Okay, I go to Lewistown with some
frequency. I'll do my best to stop in.
We're moving now to panel five. It says Mr. Fellner again.
It couldn't be true that it is Mr. Fellner again, could it?
Mr. Sparlin, we have Ms. Seminario again and Jacquelin
Nowell and Jerry Wood. Ms. Nowell, let's begin with you, if we
may.
STATEMENT OF JACQUELINE NOWELL, DIRECTOR, SAFETY AND
HEALTH, UNITED FOOD AND COMMERCIAL WORKERS
INTERNATIONAL UNION
Ms. Nowell. Thank you very much.
Senator Specter. Director of Safety and Health, United Food
and Commercial Workers International Union.
Ms. Nowell. Thank you Mr. Chairman. United Food and
Commercial Workers represents 1.4 million workers in the United
States and Canada, primarily in the retail trades and food
processing industries.
The UFCW strongly supported the repealed OSHA ergonomic
standard because it contained the basic core elements that we
helped develop with our companies over the last 10 years, 12
years, the same elements that OSHA saw was working in
companies, those of medical management, job analysis and
control, worker involvement, training and surveillance. We had
hoped that a standard would get this beyond just our industries
and the industries that other panelists have talked about where
this is working so that all workers would be protected.
We have been involved in this issue for 20 years. We know
that controlling exposure to ergonomic hazards worked. We've
seen it happen. Our members were being hurt in record numbers.
Ergonomics really was the answer.
I want to raise a couple of issues, one is the issue of
guidelines. I brought with me a copy of the red meat guidelines
that Secretary Chao has referred to in her submitted testimony.
Contrary to her testimony, these must be taken in context.
These came out in 1990 right in the middle of intense
enforcement activity by the agency in this industry. There were
record numbers of injuries in here, rampant medical
mismanagement of workers. There was major enforcement activity,
very high fines for lack of record keeping, for example, for
not treating workers medically.
In that context, these guidelines were developed and they
were developed in the context of OSHA moving forward on a
standard. They would not work in a vacuum. They only were
successful because they were part of that whole picture, so
that needs to be in this record. We have participated in these
types of programs over the years, including the corporate-wide
settlement agreements that came out of this massive enforcement
effort that was done in the meat packing industry.
Let me get at a few of the statistics which are very real,
not only from the Bureau of Labor Statistics but from the
industries themselves. The Bureau of Labor Statistics, if you
look at their statistics from 1991 to 1996 there was a 38
percent reduction in the rate of MSDs, right at the heart of
again, enforcement, the red meat guidelines and a push for a
standard from the agency and the department itself.
The AMI itself testified during the hearings that there was
in 10 years since the enforcement and guidelines reduced levels
of injuries and illnesses by a third and half of the lost time
injuries had been reduced.
The Food Marketing Institute, one of the trade groups that
was foremost in trying to trash this whole process of a
standard states that there was a 30--there has been a 33
percent reduction in the number of injuries and illnesses
caused by ergonomic hazards in the course of their work trying
to reduce them.
One meat packing plant reports a 75 percent reduction in
turnover and having recouped all of their investment, economic
investment over a 2-year period of first putting in this
program. Another over 10 years reports a 78 percent reduction
in MSDs.
prepared statement
I want to speak to the injuries themselves. Senator Harkins
spoke of Gloria Boyd this morning. Not only was she injured on
the job but when she had to move off a job that the company
refused to fix, so that all workers could work it, she lost
about $100 a week. That is not only a physical injury but a
financial injury to these workers. Workers need protection
programs that--programs work but only in the context of
enforcement. We must have a standard for all workers. Thank
you.
[The statement follows:]
Prepared Statement of Jacqueline Nowell
Good morning, my name is Jacqueline Nowell and I'm the Director of
the Occupational Safety and Health Office, the United Food and
Commercial Workers International Union, UFCW.
The UFCW is the largest private sector union in North America,
representing 1.4 million workers in the retail food, warehousing,
healthcare, garment and textile, footwear and chemical industries. We
are the largest organization of food processing workers in the United
States. We put breakfast, lunch and dinner on the table for America's
families. To feed America's families, thousands of food processing
workers are needlessly crippled and maimed each year. Meatpacking and
poultry processing have some of the highest incidences of repetitive
motion injuries in the country.
The UFCW strongly supported OSHA's ergonomics program standard. We
have been actively involved in this issue for nearly 20 years, since
the early 1980s. Our members were being hurt in record numbers. We
began by educating them about the problems of musculoskeletal
disorders, MSDs, and the lack of programs and fixes for them in our
industries. We filed OSHA complaints in the meatpacking, poultry and
cat fish industries. We pressed Labor Secretary Elizabeth Dole for a
standard to address the workplace hazards causing MSDs. We worked
closely with the Department of Labor and Secretary Dole in developing
the Red Meat Guidelines, issued in 1990. In 1991, the UFCW, AFL-CIO and
29 other unions petitioned OSHA for an Emergency Temporary Standard. In
1992, under Secretary Lynn Martin, the Department of Labor agreed with
the unions that available information supported initiation of Section
6(b)(5) rulemaking under the OSH Act to address ergonomic hazards. The
OSHA ergonomics standard was 10 years in the making, begun by a
Republican administration, and long overdue. This standard that was
designed to prevent crippling MSDs, the nation's number one job safety
problem, was debated in the Senate for 10 hours, while the House gave
the issue one hour of consideration. It was finally killed when the
President signed the repeal on March 20, 2001, two months after it had
gone into effect.
My testimony today will focus on why a standard is needed, through
worker stories and successful ergonomics programs in our industries. I
would be remiss, however, if I did not take this opportunity to let you
know how disappointed our members were with the elimination of the
ergonomic standard. By using the Congressional Review Act, a previously
unused and untested legislative tool, the ergonomic standard was
obliterated. Workers now feel, with some justification, that the
Federal government has turned it's back on their ergonomic injuries. I
would like to submit for the record a copy of a letter that was sent by
our International President, Doug Dority, to Members who killed the
worker safety standard. At the same time, we feel nothing but gratitude
to those who stood up when workers needed it most.
MSDs are real injuries--they often lead to disability and can have
a lifetime affect on workers lives. Caroline Shebora is a cashier in a
grocery store in Alexandria, Virginia. She's had bilateral carpal
tunnel surgeries and is fearful that it's coming back. Her company
fought her worker's compensation claim for over 1\1/2\ years, and she
feels devastated by that after working for this one company for 27
years. Jan Garrett works in a poultry plant in Kentucky, where she
worked salvage, until she started having problems with her hands. She's
also had bilateral carpal tunnel surgeries. Her job, at a line speed of
140 birds per minute, was to cut off broken wings, broken legs, cut
skin off that had gall stains, cut tail gland if the machine missed it,
anything USDA sent down because they knew Jan would wash, cut, trim and
vacuum trying to salvage any of the bird at all. Her life has been
completely changed, both at work and home. She can't hang out her
laundry, can't clean her house, especially using cleaners that come in
spray bottles. Her family bought their first home last summer and her
husband and sister had to clean it. To this day, she still hasn't been
able to wash the windows. She is afraid, now that she's back on a knife
job at the plant, that she won't be able to keep up, and the plant will
tell her they have no work for her. Gloria Boyd has worked at the IBP
pork processing plant in Waterloo, Iowa for nine years. She was
diagnosed with carpal tunnel syndrome as a result of the job she did,
cutting bone from picnic hams. She couldn't do anything, couldn't
especially grip a knife. She was off the job, on light duty for six
months. Getting injured was a real financial as well as physical
hardship. She lost her incentive, her pay was reduced $100 a week. She
was never able to go back to the higher paying knife job, because every
time she tried, the CTS would come back.
The UFCW has many ergonomics programs with full union participation
in our represented industries that are working to reduce MSDs. Many
industries we represent have recognized the problem for more than 15
years, and have developed ergonomics programs. These include meat, cat
fish, retail and boot and shoe. One meatpacking company reduced its
worker's compensation costs by nearly 60 percent, reduced turnover by
75 percent and recouped all of their investment in the first two years
of the program. In the first two years of the program, the number of
diagnosed cases of MSDs was halved and the number of surgeries in the
plant fell by 40 percent. Another collectively-bargained ergonomics
program in meatpacking has a worker doing most of the ergonomic changes
in the plant. That plant has reduced the number of MSD cases in the 10
years of the program by over 78 percent! In a boot and shoe plant, MSD
cases were reduced by 70 percent in two high-hazard departments after
the company began an ergonomics program. The standard was programmatic
rather than specification-based, meaning it was a flexible set of
requirements that business would have been able to adapt to its
establishments. And it was based on the experience of companies like
our, ones that have developed and implemented successful ergonomic
programs.
The retail industries have recognized the problem of poor ergonomic
design for years. One chain, Stop and Shop Supermarket Company, has a
joint program with the UFCW that addresses the high hazard areas of the
stores and provides training for the Safety and Ergonomics Committees
in each store. The Food Marketing Institute, a trade group for the
industry, has educated themselves and their members about the issue of
MSDs and back injuries related to job design as well as commissioned
and gathered scientific data on the issue. As well, they claim that the
injury rate has declined 33 percent in 10 years of voluntary grocery
industry efforts to reduce worker injuries. Unfortunately, this same
trade group made exaggerated claims about the ergonomics standard,
telling its members that they would suffer greatly from a mandatory
standard, including that they would have to hire baggers, that
customers would have to bag their own groceries and that the price of
groceries would increase as a result of the standard. They also claimed
that baggers, according to the standard, would be prevented from
lifting more than 15 pounds. These scare tactics we believe aimed at
generating opposition to the standard rather than concrete criticism of
the standard itself, which would have been far more useful for all
parties.
Workers are being hurt--Jan, Gloria and Caroline are but examples
of the hundreds of thousands of workers--you can see these workers when
you go into your own neighborhood grocery store--in the United States
who are developing MSDs. They come from small plants and large ones;
union ones and non-union ones. The point is it doesn't matter where
they work, they need protection. We've been working to get those
protections for them. We think an ergonomic standard is the answer.
Thank you for the opportunity to speak to you about this important
issue for workers.
Attachment:
United Food & Commerical Workers
International Union, AFL-CIO & CLC,
Washington, DC, April 12, 2001.
Hon. ____,
U.S. Senate, Senate Office Building, Washington DC.
Dear Senator ____: The more than 600,000 workers who are injured
and crippled each year from ergonomic hazards in the workplace feel
betrayed by the congressional vote on the ergonomics standard. Hundreds
of thousands more workers will now suffer preventable pain and injury
as well as needless job and income loss. In addition, thousands of
employers will face additional costs in health care, workers'
compensation, and reduced productivity.
The campaign waged against the ergonomics standard was marked by
misstatements, distortions, and lies. There were no congressional
hearings, no public forums, and no opportunities for workers to share
their real-life experiences either as casualties of ergonomic hazards
or as participants in programs that have successfully eliminated such
hazards. We believe that many votes against the standard were the
direct result of the misinformation campaign.
On behalf of the 1.4 million members of the United Food and
Commercial Workers International Union (UFCW), I extend to you an
invitation to meet with workers, and to visit workplaces that will give
you a broader understanding, and allow you to make a more informed
judgement of both the problems and solutions regarding ergonomic
hazards. UFCW has nationally recognized model programs that have both
significantly reduced injuries and decreased costs for employers.
UFCW is happy to arrange the meetings with workers and the
workplace visits to meet your schedule.
Secretary of Labor Elaine Chao took the opportunity to meet with
workers on March 14, 2001, at UFCW headquarters. We believe that her
willingness to hear from workers can be an important step in building a
consensus on a solution to ergonomic hazards. As Secretary Chao noted,
Congress must be part of the consensus-building process.
We hope you wilt take this opportunity to gain a firsthand
understanding of this issue, and to see the devastation of workers'
lives that comes with ergonomic hazards. Please contact the UFCW
Legislative and Political Affairs Department at your earliest possible
convenience to discuss a workplace visit.
America's workers are counting on you to hear their concerns and
act on their needs for safe workplaces. We hope to hear from you soon.
Sincerely,
Douglas H. Dority,
International President.
Senator Specter. Thank you Ms. Nowell. We now turn to Jerry
Wood, legislative chairman, Local 7800, Communication Workers
of America.
STATEMENT OF JERRI WOOD, LEGISLATIVE CHAIRMAN, LOCAL
7800, COMMUNICATION WORKERS OF AMERICA
Ms. Wood. Good afternoon, Senator Specter, Mr. Chair. I am
Jerry Wood, the legislative chair for the Communication Workers
of America Local 7800 in Seattle and I am also a customer
communications technician with over 28 years of service for
Qwest Communications, formerly US West and Pacific Northwest
Bell.
I really appreciate the opportunity to testify before you
and your committee today. I would like to address two important
issues regarding workplace ergonomics, the first involves
achieving economic--excuse me, ergonomic changes in the
workplace. I will illustrate this concern by presenting a
success story between my union, the Communication Workers of
America and our employer of record at that time, US West which
is now known as Qwest. The second deals with what still needs
to be accomplished regarding workplace ergonomics.
Mr. Chairman, in 1990 when our company was US West, we had
a work group known as the centralized mail remittance center
that processed all incoming payments for our--from our
company's customers. The job entailed the following procedures:
workers loading mail into a machine that sliced the envelopes
open, removing the mail like the bills, checks, cash from the
envelopes, keying in the payment information and processing the
received checks and cash and then finally collecting and
bundling the paper documents.
The performance of this work involved extensive repetitive
motions performed in very hot and extremely dusty and dirty
working conditions. In turn, these conditions laid to the
occurrence of a high rate of employee repetitive motion
illnesses, cases of skin rash and resultant Workers
Compensation claims and awards. In addition, worker morale and
productivity were extremely low. It was not a very pretty
picture.
Initially my union attempted to resolve these issues with
US West through our collective bargaining process. For an
extended period of time, affected employees complained to the
management and to the local union stewards of the inadequate
ergonomic working conditions and the related health problems.
In turn without success, the union utilized the contract's
grievance process. However, lacking--excuse me--lacking
agreement from the employer to provide safe and healthful
working conditions necessary to minimize or eliminate the
identified repetitive motion problems, CWA filed a complaint
with WISHA, which is our Washington State Industrial Safety and
Health Administration for relief.
In 1992 after citing the company under the general duty
clause of the Occupational Safety and Healthy Act for
violations regarding inadequate ergonomic working conditions,
WISHA and the employer negotiated a settlement agreement
intended to resolve the identified areas of concern.
Mr. Chairman, the settlement agreement resulted in US West
providing ergonomic and safe and helpful working conditions for
all affected employees in that workroom. Components of the
settlement agreement included the establishment an ergonomic
task force, the development of a workplace ergonomics training
program--excuse me--program. Subsequently initial and refresher
training was provided to all current and new employees.
Training topics included the principles of ergonomics,
appropriate body postures, the proper positioning of your
hands, your wrists, your legs, illumination and glare, and the
use of physical exercises and stretch breaks and the reporting
of occupational injuries and illness.
The creation of an ergonomics program. This program
included the conducting of periodic work site inspections. In
turn, short and long-term recommendations for improvements in
working conditions remains. The implementation of lighting
fixtures and the provision of appropriate workplace
illumination. The provision of appropriate physical workplace
accommodation such as foot rests, wrist rests and back supports
and I'll hurry up as I see the yellow light is lit.
All of these topics are important components of a
comprehensive ergonomics program and standard and since the
negotiation and implementation of this settlement agreement,
our members have not experienced any complaints of pain,
discomfort or illness associated with repetitive motion or
cumulative trauma and that is been for almost 8, 9 years now.
No one has had a problem in this work group.
Mr. Chairman, when this problem was identified nearly
everyone in this work group had suffered some form of
musculoskeletal or cumulative stress disorder. And what does
that mean? For business it means money. The return on
investment is great. With fewer illnesses and injuries the
productivity is up. Less money is spent on medical management
and Workmans Compensation. For the employees, they can come to
work and not worry about being injured. There is no loss of
earnings and they are able to have a pain free life both on and
off the job.
It is a dollars and cents issue. Unfortunately this is not
the----
Senator Specter. The time is up. If you could summarize,
please.
prepared statement
Ms. Wood. What I would like to say is that we need a
Federal standard. In our State, in Washington State where I
live and work, we have a proactive ergonomics work rule that
was adopted in May of 2000 and we're in the process of that
now. But US West, Qwest as we're now known, we do not have an
ergonomic standard that is a 14 state wide standard. We have
individual work groups that negotiate agreements with managers
based on personal relationships or, you know, how the business
is in that area.
Senator Specter. I think we have your point.
Ms. Wood. The point is we really do need this standard.
Once the pain starts, it doesn't stop.
[The statement follows:]
Prepared Statement of Jerri Wood
Good Morning Mister Chairman. I am Jerri Wood, the legislative
chair for the Communications Workers of America, Local 7800 in Seattle,
Washington and a customer communications technician with over 28 years
of service for Qwest Communications, formerly US WEST and Pacific
Northwest Bell Telephone.
I appreciate the opportunity to present testimony before the
Subcommittee on Labor, Health and Human Services, Education of the
Senate Appropriations Committee. I would like to address two important
issues regarding workplace ergonomics. The first involves achieving
ergonomic changes in the workplace. I will illustrate this concern by
presenting a success story between my union, the Communications Workers
of America, and Qwest. The second deals with what still needs to be
accomplished regarding workplace ergonomics.
Mr. Chairman, in 1990, when our company was US West, we had a work
group, known as the Centralized Mail Remittance Center, that processed
all incoming payments from the company's customers. The job entailed
the following procedures:
--workers loading mail into a machine that sliced the envelopes open,
--removing the mail, i.e., bills, checks, and/or cash, from the
envelopes,
--keying in the payment information,
--processing received checks and cash, and, finally,
--collecting and bundling the paper documents.
The performance of this work involved extensive repetitive motions
performed in very hot and extremely dusty and dirty working conditions.
In turn, these working conditions led to the occurrence of a high rate
of employee repetitive motion illnesses, cases of skin rash, and
resultant workers' compensation claims and awards. In addition worker
morale and productivity were extremely low. It was not a pretty
picture. Initially my Union attempted to resolve these issues with US
West through the collective bargaining process. For an extended period
of time, affected employees complained to management and Local union
stewards of inadequate ergonomic working conditions and related health
problems. In turn, without success, the Union utilized the contract's
grievance process. However, lacking agreement from the employer to
provide safe and healthful working conditions necessary to minimize or
eliminate the identified repetitive motion health problems, CWA Local
7800 filed a complaint with WISHA (i.e., the Washington State
Industrial Safety and Health Administration) for relief. In 1992, after
citing the company under the General Duty Clause of the Occupational
Safety and Health Act for violations regarding inadequate ergonomic
working conditions, WISHA and the employer negotiated a settlement
agreement intended to resolve the identified areas of concern.
Mr. Chairman, the settlement agreement resulted in US West
providing ergonomic and safe and healthful working conditions for all
affected employees. Components of the settlement agreement included:
--The establishment of an ergonomics task force;
--The development of a workplace ergonomics training program.
Subsequently, initial and refresher training was provided to
all current and new employees. Training topics included the
principles of ergonomics; appropriate body postures; the proper
positioning of hands, wrists, arms, and legs; illumination (and
glare); the use of physical exercises and stretch breaks; and
the reporting of occupational injuries and illnesses;
--The creation of an ergonomics program. This program included the
conducting of periodic worksite inspections. In turn, short and
long-term recommendations for improvements in working
conditions were made;
--The implementation of appropriate lighting fixtures and the
provision of appropriate workplace illumination levels;
--The provision of appropriate physical workplace accommodations such
as foot rests, wrist rests, and back supports. (US West made
sure to have an ample supply of these items so as to eliminate
delays in providing them to affected employees);
--The development of procedures that called for the rotation of job
functions within affected work groups;
--The establishment of a medical management program. In part, this
involved the medical surveillance of workers and a review of
ongoing employee cumulative trauma disorders. In addition,
affected occupational and management employees were provided
education materials regarding the causes and early symptoms of
repetitive motion illnesses; and
--The introduction of equipment that would eliminate or significantly
minimize the amount of paper dust within the workplace.
All of these topics are important components of a comprehensive
ergonomics program and standard.
Since the negotiation and implementation of the settlement
agreement, our members have not experienced any complaints of pain,
discomfort, or illness associated with repetitive motion or cumulative
trauma. In addition, exposure to paper dust has been greatly minimized.
Mr. Chairman, when this problem was identified, nearly every
employee in the centralized mail remittance center work group suffered
from some form of musculoskeletal or cumulative trauma disorder. Today,
there are no reported cases of repetitive motion illness. What does
that mean?
For the business it means money. The return on investment is great.
With fewer illnesses and injuries, productivity is up. Less money is
spent on medical management and workers' compensation. For the
employees, they can come to work and not worry about being injured.
There is no loss of earnings. They are able to have a pain free life
both on and off the job. They can participate fully in their family
life, without limitations. These things cannot be measured in dollars
and cents. This is a success story that CWA and US WEST learned a lot
from.
Unfortunately, this is not the case in all corporations, and even
at Qwest, some lessons need to be revisited. We still have work groups
where ergonomics and work place safety are unheard of. As we sit here
today, many of our members will be hurt and continue hurting after
their workday is finished because the emphasis is on the bottom line,
the all-mighty dollar. For some reason, we as a nation are willing to
play the game of chicken, pitting the financial health of our
businesses and the physical, emotional and financial well being of
their employees against this mighty bottom line.
If you can prevent an injury from happening, you save money in lost
time wages, doctors and therapy visits, prescriptions, hospitalization
and so on. Dollars spent in this manner produce no positive return on
the employer's investment. In fact, they actually take money away from
the bottom line. If employers spend money, as US WEST did in 1992,
creating a safer work place, educating their employees to work safer
and smarter, and providing the necessary accommodations to lessen the
impacts of repetitive motion, the employer will experience an increase
in productivity, morale, and employee and customer retention. These are
items necessary for successful employers and a healthy, thriving, and
growing economy.
Mr. Chairman, why do we need a Federal OSHA ergonomics standard?
This question is particularly important for employers with multi-state
operations, such as Qwest. A Federal standard would provide for
consistent policies and procedures within all states. On the other
hand, the establishment of different standards among different states
such as Washington, California, and others would present employers with
burdensome policy and economic scenarios. In addition, with the
establishment of consistent workplace ergonomics policies and
procedures, workers would prefer a Federal standard knowing that they
have a greater opportunity to be provided ergonomic and safe and
healthful working conditions.
As stated in the success story that I described, US WEST was not
fully motivated by a collective bargaining agreement or by some sense
of doing the right thing in correcting their problems. An outside
governmental agency, i.e., the Washington Industrial Safety and Health
Administration, with the authority to inspect, issue citations, and
levy disciplinary action was needed to convince the company to take the
necessary protective action. However, WISHA was limited insofar as they
could only use the OSHA General Duty Clause to investigate, issue
citations, and take the necessary corrective action. The establishment
of a Federal OSHA ergonomics standard would allow state OSHA plans that
do not have an ergonomics standard to more efficiently and effectively
respond to complaints and resolve inadequate workplace ergonomics.
Mr. Chairman, I have first hand knowledge of the ergonomics and
repetitive motion illness problem. I suffer from carpal tunnel and
tendonitis in both of my arms due to my job function at Qwest. I know
that if my manager had accommodated my need for an ergonomic keyboard,
I would not be suffering to the extent that I am today. For the lack of
this $25 keyboard, my employer spent over $45,000 in lost time wages,
orthopedic and therapy appointments, prescriptions and braces and
independent medical examinations, not to mention significant
administrative costs. My family lost my ability to help them at some
crucial times in their development. My customers lost my service to
them. I am a great technician. However, due to my repetitive motion
illnesses, my co-workers had to work harder; some working overtime to
cover for my absence. My company lost money, because I wasn't there to
help them make money.
Unfortunately, once the pain and suffering associated with
inadequate workplace ergonomics and the occurrence of repetitive motion
illness starts, it never stops.
Mr. Chairman, I urge you to help ease the pain and suffering of
millions of American workers who, as a result of inadequate workplace
ergonomics, have developed repetitive motion illnesses by working to
have a comprehensive Federal OSHA Ergonomic Standard established.
Thank you for your consideration of this matter.
Senator Specter. Thank you. Thank you very much. Going now
to panel number five, Mr. Fellner, Mr. Sparlin, Ms. Seminario.
When you have 26 witnesses, you get sort of repetitive.
Mr. Fellner, it is your turn. I see you are marked down
here for 3 minutes, I do not suppose you will need that long,
will you?
STATEMENT OF BARUCH A. FELLNER
Mr. Fellner. Well, as a matter of fact, I may surprise you,
Senator Specter, and during the course of my----
Senator Specter. I am just kidding, Mr. Fellner, take all 3
minutes.
Mr. Fellner. I appreciate that, but during the course of--
the reason that I may surprise you is because I think that the
search for the Holy Grail of consensus this morning may breed
more success than you had initially predicted or thought. But
before I indicate to you where that consensus might be I'd like
to correct the record.
In response to the distinguished chairman's question
directed to Dr. Barondess as to whether interventions are
effective in addressing MSDs and to the NAS's conclusion with
regard to that, he said yes. Dr. Barondess misrepresented his
report. In Appendix C, which is the panel response to the
single descent, the NAS reports states, and I quote in its
entirety, this is at page 458, the report states that
interventions influenced pain reports and not the occurrence of
specifically defined disorders of the upper extremities. The
studies are summarized in table 8.3. The report does not state
that interventions prevent carpal tunnel syndrome or indeed any
other upper extremity disorder. The emphasis rather is on the
amelioration of symptoms which is the end point in the relevant
literature.
Furthermore, the comments on upper extremity interventions
carefully state that interventions influence symptoms, not the
incidence of specific disorders. With that proposition we
agree, and that means if we return, Senator Specter to where I
began, the NAS defines disorders as an interruption in a human
being's sense of wellness. If that is what this morning's
hearing is about, Senator Specter, we can all agree that the
workplace does have some influence on individual sense of
wellness. Come Monday morning I suspect even you, Senator
Specter, are reluctant to come to the Senate. I know I am
today.
If that is what ergonomics regulation is about, if OSHA has
the authority, if we are entering 1984 Orwellian period where a
Federal agency has the authority to regulate an individual's
sense of wellness, then we have come very far. Before we do so,
Senator, I think that the Department of Labor must take a good,
long look at the process and at the science and I appreciate
it.
Senator Specter. We'll take a close look at the voluminous
report and contrast Dr. Barondess statement with your challenge
and see if your challenge is well-founded.
Ms. Seminario, I have you down for 3 more minutes.
STATEMENT OF PEG SEMINARIO, DIRECTOR, DEPARTMENT OF
OCCUPATIONAL SAFETY AND HEALTH, AFL-CIO
Ms. Seminario. Just to make a couple of points, Mr.
Chairman, as I've said earlier we've long advocated an OSHA
standard. We have recommended that such a standard be based on
the good employer practices that have worked. Those practices
are the ones that are incorporated into the red meat
guidelines. They are the practices that are in place in the UAW
program, they are the practices that were in the settlement
agreement at Qwest. They are the practices that are in the
settlement agreements in meat packing.
If you line up all of these documents and all of these
programs, they have very common elements. Most of them take a
programmatic approach that include employer commitment,
employee involvement, identification of problem jobs,
development of controls, training and education, and
appropriate medical management, and that is the practice. And
the risk factors that are addressed, the exposures that are
addressed again are the similar common exposures that workers
have with respect to the development of MSDs.
They are exposure to excessive reputation, force, awkward
postures, vibration, jobs involving a lot of manual handling as
Dr. Barondess indicated. So there is commonality when you look
at the practice in the workplace and our advice to the
Department of Labor in developing their rule is to look at that
practice and to codify that into a regulation.
Does that mean that every employer do exactly what the UAW
does or what's done at Qwest or, you know, in the meat packing
industry? No, there are, you know, obviously real differences
in risk. There are real differences in operations, but the
programmatic approach, the basic elements are the same and then
within that, the control measures are obviously ones that are
tailored to a particular workplace.
But at the heart of all this has got to be the reduction in
exposure. If you just have a program on paper, if you have a
program and a process that is not resulting in reductions and
exposure, you are still going to have injury.
Now, much has been said about the fact that there are not
only physical factors but psychosocial and organizational
factors and we agree with that. But when you look at OSHA's
authority to regulate, the physical factors resulting from the
jobs are the ones that they are best able to deal with. If OSHA
got into trying to deal with management structures in the
workplace, they got into dealing with management relationships
that have--that are at the heart of the psychosocial work
organizational factors in the workplace, you would hear much
greater screams from the employers than you have already heard.
And when we asked them about this at the hearing, should OSHA
then address the work organization and psychosocial factors,
they said no.
So OSHA tried to deal with what was in its purview and what
really was the focus of its effort. Was dealing with all risk
factors? No. It was attempting through the standard to deal
with those risk factors that they felt could be regulated
related to the workplace and related to hazards.
So that is our recommendation is to look at these practices
and then to codify them into a regulatory approach to reduce
injuries.
Senator Specter. Thank you very much, Ms. Seminario and
thank you all. In my experience having been here for some time,
this has been a very unusual hearing and the subcommittee has
gone into a lot more detail to try to understand this problem
because of our determination to see something done.
We labored long hours on conferences on this issue, year
after year after year after year and the process that has
brought us to where we are today with the regulation having
been rescinded and we have a statement by the new Secretary of
Labor that, quote, I intend to pursue a comprehensive approach
to ergonomics which may include a new rulemaking that addresses
the concern levied against the current standard. The word may
leaves latitude for not.
We intend to press on the time frame. What I hear today is
not likely to lead to consensus but is very adversarial and I
am not unused to the adversarial process and I can see the
adversarial process at work to try to influence the decision
maker. That is not unusual either.
You take an extreme position, you may end up closer to
where you want to be than if you take a conciliatory position.
That is sort of par for the course in adversarial litigation
which I think we have here. But through all of it there's been
a lot of progress through ergonomics with the companies and
we've heard employers who have come to terms.
And a big part of the problem is the administration by OSHA
of which we hear complaints everywhere and this subcommittee
has defended OSHA's budget trying to look more for
reconciliation and prevention than for adjudication and
punishment and what is going to have to happen really in the
long run is that the OSHA administration is going to have to be
populated by people who understand the concerns on both sides.
Business is going to have to put one of your high, your
really well qualified people into a key OSHA position to see to
it that OSHA doesn't overstep the bounds.
The employees at OSHA do not earn what some of the
witnesses do have testified here today and there has to be a
safety check from labor having someone there who will see to it
that they do not go too far in either direction. But the
governmental administration is a monumental task. But this is a
really very--I do not have to say this, it is been said by
everybody, an extraordinarily important program this and this
subcommittee intends to pursue it and it is my hope that we can
find some information from some of these companies which
haven't come forward and try to find some standard to address
the concerns on all sides because I think at bottom there is a
good faith effort to try to deal with workers problems, biggest
impacts on corporate profits, we know that. We all have to live
together on the planet earth.
It is exactly 12:30. That is the longest hearing this
subcommittee has had. It is over.
subcommittee recess
Thank you all very much for being here. The subcommittee
will stand in recess until 9:30 a.m., on Wednesday, May 2, when
we will meet in room SH-216 to hear from Department of Labor
Secretary Elaine L. Chao.
[Whereupon, at 12:30 p.m., Thursday, April 26, the hearing
was concluded and the subcommittee was recessed, to reconvene
at 9:30 a.m., Wednesday, May 2.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002
----------
WEDNESDAY, MAY 2, 2001
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:33 a.m., in room SH-216, Hart
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Harkin, and Murray.
DEPARTMENT OF LABOR
Office of the Secretary
STATEMENT OF ELAINE L. CHAO, SECRETARY OF LABOR
ACCOMPANIED BY JAMES McMULLEN, DEPUTY ASSISTANT SECRETARY, BUDGET
Opening statement of Senator Arlen Specter
Senator Specter. The Subcommittee, of the Appropriations
Committee on Labor, Health and Human Services, and Education
will now proceed.
We welcome Secretary of Labor, Elaine Chao, to this first
hearing on her Department's budget.
I note at the outset that the administration's
discretionary budget request for fiscal year 2002 for the
Department of Labor is $11.338 billion, which is a decrease of
some $562 million below the current budget, noting that the
total funding for the Department including mandatory programs
is $44.4 billion.
There are some increases including funding for the
disability employment policy, somewhat in excess of $20
million; for the consumer price index improvements, a little
over $8 million; and for the unemployment insurance work load
program, an increase of $65 million.
But there are some major decreases in the area of youth
activities, dislocated workers, training programs for incumbent
workers, the safe schools healthy students program, youth
offenders, and international labor affairs.
In preliminary staff inquiries, we have been advised that
some of these cuts, may be accommodated by the fact that States
have spending levels at a lower rate than expected.
But there is a real concern here. Earlier this week, I
visited a Healthy Start Center in Harrisburg, which is devoted
to trying to deal with youngsters who are at risk and may be
predisposed to criminal activity.
I was really startled to hear that the time for dealing
with at-risk children is when they are 16 months old. It seemed
fanciful to me until I heard their approach.
They say that at 16 months, children start to learn which
space is theirs, not to be aggressive and pushing other
children, learn scheduling so they have some structure in their
life. And that conduct begins at that age.
And they were very much concerned about the programs in
Healthy Start, which has had enormous improvement. Although it
is not funded by this Department, but funded by the
subcommittee, the Healthy Start staff were concerned as to what
is going to happen in the summer programs. That is a question
which the Congress has faced repeatedly and this subcommittee
has taken a very strong position trying to provide for summer
jobs for young people.
And the issue was raised as to daycare. What is going to
happen to daycare in the summer. So when I look at these cuts,
I am really concerned.
I talk about 16-month-olds, because I think that is a bit
of information which is sufficiently startling to take just a
few minutes this morning to tell you what the avant garde
thinking is on this subject.
Well, Madam Secretary, we do not have 25 witnesses behind
you today, which will give us a little more of a chance to
discuss matters. And we look forward to--I was about to say we
look forward to your statement, but timing is everything.
And, Senator Harkin, among his many, many talents, has a
way of arriving at precisely the right moment.
My distinguished partner, Senator Harkin.
Senator Harkin. Thank you very much, Mr. Chairman. And I
will just ask my statement be made a part of the record. You
are so gracious. I will just put it in the record and let us
move ahead.
Senator Specter. Oh, I see that statement. It is too long.
We cannot afford all of that on the record. We are going to
have--you will have to summarize that for----
Senator Harkin. We will have to get a new appropriation
just to print all this stuff, right?
Senator Specter. By the time we finish talking, I think we
will need several new appropriations.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
Thank you, Mr. Chairman. And thank you Secretary Chao for coming
here today. It's nice to see you again so soon. Now you know that when
this Committee says that we want to work closely with you, we're not
kidding!
Budgets are about priorities. In America, where we spend our money
reveals a great deal about what we value. The discretionary funding in
this year's Department of Labor budget is down $600 million. In a year
of unprecedented surplus, it is shocking that we are sitting here
discussing deep cuts to an agency whose mission is to protect our
Nation's workers--the very people who worked so hard to produce a
surplus.
Before I get into the concerns I have, I do want to note a positive
step made in this budget. I am pleased to see that the Department has
requested a doubling in the funding for the Office of Disability
Employment Policy, which we created last year. This office will focus
on integrating individuals with disabilities into worker training
programs, improving access to one-stop centers and coordinating with
other agencies to ensure that people with disabilities have
transportation and community-based attendant services. In many cases, a
small amount of assistance is all that is required to give these
individuals the independence that a job affords.
Aside from that shining star, I believe this budget is simply
short-sighted. First and foremost, I am confounded by the logic of
making large cuts in worker training programs just as the country
experiences rising unemployment rates. Week after week, we see news
reports about lay-offs at major companies, yet your budget calls for a
$200 million cut from training programs for dislocated workers.
If we are to encourage innovation in the marketplace, industry
NEEDS highly skilled workers and it is in our best interests to provide
those workers here in America. I am disappointed to see that, out of
the $600 million cut in overall Department of Labor funding, $473.9
million of that comes from Employment and Training Programs. That is 79
percent of the total decrease in the Department!
Another example of the short-sightedness of this budget is this
Administration's proposal to cut the Bureau of International Labor
Affairs by 65-75 percent. In this era of globalization, American
workers are now pitted against workers throughout the global economy in
tough, hard-nosed competition as never before. Their jobs and living
standards are at unprecedented risk.
Now I am not worried about the productivity of American workers to
compete and win on a level playing field. But the sad truth is there
are many trading countries that deliberately refuse to enforce their
own national laws to respect basic worker rights and labor standards,
let alone meet their international legal obligations.
I am deeply concerned that this administration is proposing such
drastic cuts in the part of the Federal Government which has the
greatest expertise in labor standards and international worker rights
issues, such as abusive child labor. These cuts could not come at a
worse time: U.S. policy-makers need ILAB help more than ever including
President Bush, who says there are legitimate trade-related worker
rights issues that must be addressed in the impending fast-track
debate.
Finally, I am disturbed by the reductions in worker safety and
health standards. In the last year, workforce data has illustrated that
Americans are working more hours than ever before. There is a $1.2
million reduction in safety and health standards, a $3 million cut in
training grants, cuts in state programs, technical support and a
reduction of 94 full-time staff!
Cutting support for worker training, global workforce and basic
safety and health standards for our workers--these actions are classic
examples of cutting off your nose to spite your face. The surplus was
built on the backs of America's workers and if we as a Nation want to
prosper in the 21st century, we will need a workforce that is well-
trained, highly-skilled, and does not have to fear being injured due to
hazardous working conditions. To do any less is to put America's
prosperity in danger.
Summary statement of hon. Elaine L. Chao
Senator Specter. Well, in a very unusual move, Secretary
Chao, Senator Harkin has deferred to you. I do not think he
would have done it to anybody else.
Senator Harkin. You are in rare form this morning.
Senator Specter. The floor is yours.
Secretary Chao. Thank you very much. And, of course, to the
ranking member, I appreciate that courtesy.
Mr. Chairman, now that I know what the lights are for, I
have made my statements very short to fit into the time frame.
And I do have a written record--statement that I would like to
be submitted for the record.
Senator Specter. The full statement will be made a part of
the record. Madam Secretary, with only one witness, we do not
use the lights.
Secretary Chao. Oh, okay. Thank you.
I do want to address your issues because they are important
as well. I do have a little summary.
As you mentioned, the Department's overall fiscal year 2002
budget request is $44.4 billion. It is up from $39.2 billion
from the previous year. It is about a 13.27 percent increase.
The FTE's is approximately 17,483. The discretionary request is
$11.3 billion.
I think it is important to point out here that the
Department of Labor's budget is part of the entire
administration's budget, prepared with the assistance of all
the Cabinet Secretaries and under the guidance of the President
and the Office of Management and Budget.
The President's budget, which will grow about 4.1 percent
per year, protects Social Security and Medicare, pays down the
national debt and provides working families with meaningful,
needed tax relief.
At my confirmation hearing 3 months ago, I identified five
key areas for the Department that are reflected in the budget
that we have submitted today.
And these priorities are obviously: One, to ensure the
safety and health of every workplace; to guarantee an honest
day's pay for an honest day's work; to fight discrimination; to
protect workers from coercion and intimidation; and to make
sure workers' pensions are protected.
And, of course, there is the overriding theme that I have
worked a great deal on, and that is workforce training and
development.
The Department of Labor has done a great deal to protect
workers, but needs to do more to prepare workers for the new
economy, for dislocations that result from trade, and for
changes in skill needs.
And so to bring focus and drive to this mission, a new
Office of the 21st Century Workforce has been created within
the Department. It is funded out of existing resources.
The Department will hold a summit on the 21st Century
Workforce on June 20 of this year, where leaders from business,
labor unions, government, and academia will address the
fundamental changes affecting our country's workforce and
economy.
Let me comment a bit about the five goals. The first goal
is to ensure the safety and health of every workplace. There is
no question that the Department needs to be in the business of
assisting workers through employers before an accident occurs.
Enforcement is a critical part of the Department's job. I
am fully committed to that. And OSHA, indeed, has issued about
38 fines of over $100,000 in the last year. But what I have
tried to emphasize also is that after-the-fact enforcement is
not going to ease a family's grief when a loved one is injured
or killed.
And so I would like to put more emphasis on compliance
assistance, so that we can truly help workers, to protect them
before an accident occurs. OSHA's budget request is $426
million for the 2002 fiscal year. MSHA's is $246 million.
The second goal, of course, is to guarantee an honest day's
pay for an honest day's work. And the Department needs to
enforce our common sense laws about labor practices, and not
just a reflexive one-size-fits-all approach.
The Department's request maintains our worker protection
agencies at 2001 levels. We are expanding our efforts in 2002
on compliance assistance activities. And if I can just point
out, since 1996, the Department has realized a 36 percent
increase in worker protection programs.
The Employment Standards Administration, which includes the
Wage and Hour division, has a fiscal year 2002 budget of $284
million.
The third goal was to fight discrimination. And we are
thankful to the ranking member to have helped in the
establishment of the Office of Disability Employment Policy.
Mr. Harkin, I know how strongly you feel about that, and we
look very much forward to working with you in making sure that
the mission of this office is totally fulfilled.
We have allotted $20 million extra on top of last year's.
And we expect to have ten FTE's for this office in 2001. And as
you well know, the President feels strongly about this as well,
because of his new freedom initiative.
The Department also has an important role in worker
protection abroad. And as the chairman mentioned, we do have
the Department's Bureau of International Labor Affairs.
This Department's program has increased 77 percent over
fiscal year 1999. And for fiscal year 2002, the Department is
requesting a smaller amount of $72 million, but 100 FTE's for
international labor activities. And I will speak more to that,
I am sure, as we go on this.
The fifth goal is to make sure that workers' pensions are
protected. And I have recently met with Attorney General
Ashcroft to ensure that the Departments of Justice and Labor
will work together and to protect our workers' pension funds.
And Pension Welfare Benefits Administration, which guards the
integrity of our Nation's pension funds has a budget request of
$108 million.
This pretty much is an overview of the plans for the
Department of Labor. I emphasize once again how important it is
for the Department not just to react to change, but try to
anticipate them.
We want to help workers adjust to a 21st Century workforce.
And that is why we are spending a great deal of time on
training and development.
There are concerns about the 5 percent reduction in the
budget. And as the chairman has pointed out, a great deal of
that decision was based on the overhang of unexpended funds.
We do have an unexpended fund balance of $1.7 billion.
Usually, the unexpended funds balance is about $1 billion. So
this year, we have well over $700,000,000.
So while the budget has been cut back, $542 million, that,
again, is more than taken care of by the larger than usual
excess from the previous year.
We are also spending $80 million on new technology to
ensure that the Department is up to speed. We are spending
another, I believe, $40 million on BLS to ensure that the
Bureau of Labor Statistics is providing up-to-date and truly
relevant information. And it is a wonderful organization.
prepared statement
But I am kind of rambling on, so I will stop here and be
happy to answer any questions.
Senator Specter. Thank you very much, Secretary Chao.
[The statement follows:]
Prepared Statement of Hon. Elaine L. Chao
Mr. Chairman, and distinguished Members of the Subcommittee, thank
you for the opportunity to appear before you today to present the
Department of Labor's fiscal year 2002 Budget.
The President's 2002 budget moderates the Federal Government's
recent rapid growth in spending while funding national priorities,
paying down the debt, and providing tax relief. The Department of
Labor's budget request for 2002 follows this responsible approach and
will serve as the foundation for us to become a 21st Century Department
of Labor.
Before I discuss the specifics of the Department's 2002 request, I
would like to highlight a new addition to the Department of Labor. We
at the Department of Labor need to provide a beacon of hope, finding
solutions for the problems facing our Nation's workers and the economy
as a whole. Thanks to the bipartisan work of Congress, we have a new
road map--the Workforce Investment Act--to lead us toward this goal.
Along with states and localities, the professionals in our Employment
and Training Administration are diligently implementing this new
legislation. But we need even more fresh ideas, fresh approaches, and
new partnerships to help us succeed in this journey. That is why I am
creating within the Department a new Office of the 21st Century
Workforce to bring focus and drive to this mission.
This Office will be funded out of existing resources and its first
responsibility will be to hold a Summit on the 21st Century Workforce
on June 20, 2001. At the Summit, I will call on leaders from business,
labor unions, government, and academia to address the structural
changes affecting our workforce and our economy.
We need to review every aspect of this Department's work to ensure
that we are helping, not hindering, the development of a workforce that
is ready for the future. We want to give workers the flexibility to
custom-design their work to fit their lives--and not the other way
around. But I want to make clear that this focus on the 21st Century
workforce is about a lot more than just making sure Silicon Valley has
enough engineers. Every worker should have the opportunity for a
fulfilling and financially rewarding career.
Given everything we are setting into motion with our 2002 budget
request, our mission at the Department of Labor must not be just to
react to changes, but to anticipate them and help the Nation's
workforce adapt to them. Better yet, the workforce should be able to
take advantage of those changes. We need to recognize that the 21st
Century economy is not the same one we grew up with and that America's
21st Century workforce has to adjust. To help people do that--to give
workers constant hope in a changing world--we need to become a 21st
Century Department of Labor.
At the Department of Labor, it is about making sure that no worker
is left behind--like those who have been laid off from jobs because
their company could not keep up with technological changes or foreign
competition, those who did not get a full education, or those who made
a wrong turn at some point in their lives and are trying to make it
back. And, as the President has insisted, we must reach out to those
who have been denied the opportunity for a productive, meaningful work
life because of a disability. At the Department of Labor, we are
prepared to do just that.
As for our fiscal year 2002 budget, the Department's overall
request is 17,483 Full-Time Equivalents (FTE) and $44.4 billion in
budget authority, of which $13.6 billion is subject to the annual
appropriations process and is now pending, Mr. Chairman, before your
Subcommittee. The request for discretionary programs is $11.3 billion
in budget authority, which is $564 million less than 2001--with a net
reduction of 184 FTE. In a country experiencing a current skills gap
and a long-term worker shortage, this is a budget request that will
allow America to achieve its full potential while still maintaining a
responsible fiscal approach with precious taxpayer resources.
employment and training programs
The Department's fiscal year 2002 budget for Employment and
Training Programs is $6.8 billion. Included in this total is $2.3
billion, which is targeted for employment and training programs for
adults--including $1.4 billion for employment and training activities
for dislocated workers. In addition, $2.7 billion is requested for
youth employment and training programs--including $1.4 billion for Job
Corps--to help young people make a successful transition to the world
of work and family responsibility.
This budget represents a net decrease of $474 million from 2001,
which is largely due to decreases of $359 million in formula grants
related to the availability of large amounts of State unexpended
carryover which can be used in lieu of new budget authority. I want to
be clear, Mr. Chairman: there will be no diminution of service. We are
prepared to serve the same number of participants as in 2001. It is
estimated that $1.6 billion in unexpended youth, adult, and dislocated
worker funds will be carried into 2002--approximately $600 million more
than what is typically realized, which is due largely to the
implementation of the Workforce Investment Act.
disability employment policy
The 2002 budget provides $43.2 million and 67 FTE to fund the
Department's work toward eliminating policy barriers that impede the
employment of people with disabilities.
A particular highlight for the Department is the new Office of
Disability Employment Policy (ODEP). The 2002 budget includes $40.6
million and 57 FTE for ODEP, an increase of $20.3 million and 10 FTE
over 2001, to support key elements of the President's New Freedom
Initiative in areas that focus on integrating Americans with
disabilities into the workforce.
The increase includes $6 million and 3 FTE to expand one-stop
accessibility grants and support the process of ticket-to-work through
One-Stop Career Centers; an additional $6 million and 3 FTE to build on
the Youth-to-Work Grant program and ensure that young people with
disabilities benefit from youth programs under the Workforce Investment
Act; and $8.3 million and 4 FTE for an Olmstead grant program to assist
persons with significant disabilities in making the transition from
institutional settings to the community and employment.
The Task Force on the Employment of Adults with Disabilities will
continue its efforts to create a coordinated and aggressive national
policy to bring adults with disabilities into gainful employment. The
Task Force will deliver its fourth and final report to President Bush
by July 26, 2002, the twelfth anniversary of the Americans with
Disabilities Act. The 2002 budget includes $2.6 million and 10 FTE for
the Task Force to complete its mission.
worker protection/compliance assistance
The Department's 2002 request maintains our worker protection
agencies at 2001 levels, and we are expanding our efforts in 2002 for
compliance assistance activities. An example of prior rapid growth in
spending can be found in our worker protection programs. Since 1996,
the Department has realized a 36 percent increase for worker protection
programs, which significantly outpaced inflation. From providing for
the safety of every worker's pension, to ensuring the safety of every
workplace, and from ensuring that Federal contractors provide equal
opportunities to their workers, to ensuring that all employers comply
with the Nation's wage and hour laws, a responsible fiscal approach
will allow us to moderate recent growth in Federal spending while still
realizing the same levels of worker protection.
I want to be clear on what we wish to achieve: we will continue to
make administration of labor laws a top priority, but with an eye
toward a common sense, flexible approach that aims to protect workers
and help employers comply with the law. To more effectively and
efficiently administer our laws, our worker protection agencies will be
emphasizing more--and better--compliance assistance as our initial
strategy in preventing workplace injuries and illnesses and violations
of labor laws.
One example of more and better compliance assistance is the
Occupational Safety and Health Administration's approach to
implementing its new ``Needlestick'' rule. We have a proactive strategy
to ensure that employers understand this new rule--which includes
extensive outreach and educational efforts before rule enforcement.
This approach will allow everyone involved--the Department, employers,
and workers--to focus on the prevention of needlesticks and other
similar injuries to workers.
Worker protection laws are only as effective as the degree to which
they are understood and followed. By emphasizing compliance assistance,
we help both employers and workers understand not only a rule's
requirements but also how best to avoid the injury or illness the rule
is designed to prevent. Each time I hear about safety violations that
were discovered after an accident that cost the life of an employee, I
cannot help but feel great sadness. After-the-fact enforcement cannot
ease a family's grief when a loved one is injured or killed on the job.
If we really are going to protect workers, we must put more emphasis on
prevention. By enforcing laws before injuries or illnesses occur, and
by helping employers provide the necessary levels of protection and
meet their compliance obligations, we can and will save workers' lives.
labor statistics
The 2002 request includes $25 million in additional funding for the
Bureau of Labor Statistics, including $8.1 million and 40 FTE for a key
step in fundamentally changing the manner in which the Consumer Price
Index (CPI) is revised and updated. For some time, the Bureau has
worked to improve the accuracy and timeliness of the CPI. The
additional funds requested in 2002 are critical to the continuation of
this effort, which has as its goal the production of a more up-to-date
CPI and should substantially reduce the need for large periodic
increases like those historically requested.
international labor affairs
The Department requests $71.6 million and 100 FTE for international
labor activities in 2002. This request recognizes the importance of
promoting international labor standards and reducing abusive child
labor throughout the world. I believe the Administration's request
helps us to effectively balance our priorities on these critical issues
while maintaining sensible spending policies.
Our 2002 request preserves the Bureau of International Labor
Affairs' (ILAB) core responsibilities and allows the Department to
integrate activities in ILAB with the overall foreign policy of the
Administration. In this budget, ILAB continues its work on the global
HIV/AIDS initiative begun in fiscal year 2001 and continues bilateral
and multilateral projects to assist developing countries in
establishing basic labor protections, enabling more and more workers to
enjoy fundamental employee rights.
unemployment insurance
The fiscal year 2002 budget includes a request of $2.4 billion for
Unemployment Insurance administration. This is an additional $50
million above the fiscal year 2001 appropriation level, to reflect the
increased unemployment insurance claims workload under the President's
economic assumptions. The increase reflects an average weekly insured
unemployment (AWIU) rate of 2.622 million compared with the 2.396
million level set in the fiscal year 2001 appropriations.
energy employees' occupational illness compensation program act
The Department's budget includes $136 million and 413 FTE for
administration of the Energy Employees' Occupational Illness
Compensation Program. In addition, $597 million will provide
compensation and medical benefits to eligible workers and survivors.
advance appropriation
The Administration proposes to reverse the budget practice of using
advance appropriations simply to avoid spending limitations.
Accordingly, the amount requested to be appropriated for the 2002
budget is sufficient to provide normal funding, and no advance
appropriation is requested. In order to avoid overstating discretionary
budget authority in fiscal year 2002, language is proposed to designate
the Department's advance appropriation budget authority of $2.463
billion as direct spending. The Administration is committed to
resolving this issue in the fiscal year 2002 Budget.
veterans' employment and training service
For 2002, the Department requests $211.7 million for the Veterans'
Employment and Training Service (VETS), the same funding level as for
2001. This request includes 250 FTE to accomplish the VETS mission of
providing employment and training opportunities for veterans through
the public employment service and other employment and training
programs, as well as protecting veterans' employment and re-employment
rights. The 2002 request continues the funding of the Homeless Veterans
Reintegration Project at $17.5 million. This program, as authorized by
the Stewart B. McKinney Homeless Assistance Act and title 38, will
provide employment and training assistance to homeless veterans, with
expected job placements of approximately 10,000.
information technology
A total of $80 million--an increase of $43 million over 2001--is
requested for the centralized Information Technology (IT) account to
fund the Department's IT investments within four cross-cutting areas:
$40.5 million for Enterprise Architecture; $10.6 million for a Common
Office Automation Suite; $19.7 million for Security and Privacy; and
$9.1 million for Common Administrative Systems. This request will
support the second year of our efforts to replace duplicative and
disparate systems with a coordinated approach to provide centralized
information technology investments managed by the Department's Chief
Information Officer. These IT resources will help ensure program
effectiveness among DOL programs and are key to my renewed commitment
to compliance assistance through maximum use of technology.
government performance and results act
There is a small--but important--amount of $5 million in our 2002
request for a centralized fund to finance program evaluations,
primarily in the Department's worker protection agencies. These funds
will be used to improve overall program effectiveness and data quality
pursuant to the Government Performance and Results Act (GPRA) of 1993.
The Department has made significant strides in implementing the
provisions of GPRA and we believe that funding for program evaluations
will provide data that can be used to further evaluate and improve
program effectiveness and data quality. In addition, the Budget request
for the Employment and Training Administration includes $9 million to
evaluate job training programs, including an evaluation of the
Workforce Investment Act's performance management system.
grant accountability
$1.8 million is requested to improve the Department's
administration of grant funds to improve the timeliness, accuracy, and
usefulness of financial and performance information. $1.5 million of
this increase would go to the Employment and Training Administration to
increase its financial management capacity and strengthen program
management through specialized oversight and assistance to states and
other grantees. The Office of the Chief Financial Officer will use the
remaining $300 thousand to develop financial tools for grant programs
and provide added oversight to grantee cost reporting.
federal employees' compensation act surcharge
The President's 2002 budget includes a proposal to amend the
Federal Employees' Compensation Act (FECA) to provide for a surcharge,
to be paid by each agency, to finance the administration of the FECA
program. The surcharge will replace the $80.3 million in budget
authority to finance fiscal year 2002 program administrative costs and
will be based on the amount of the workers' compensation benefits paid
by each agency. The purpose of this surcharge is to boost Federal
agency incentives for improving safety in their respective workplaces.
trade adjustment assistance (taa)/north american free trade agreement-
transitional adjustment assistance (nafta-taa)
For fiscal year 2002, $415.7 million is requested for the
Employment and Training Administration's Federal Unemployment Benefits
and Allowances. Legislation will be proposed at a later date to
reauthorize the TAA and NAFTA-TAA programs, which expire on September
30, 2001.
Mr. Chairman, this is an overview of what we have planned at the
Department of Labor for fiscal year 2002. While the President's 2002
budget presents a responsible approach to meet the needs of America's
workers--including funding national priorities, paying down the debt,
and providing tax relief--it will also ensure that our Nation's workers
are prepared for the 21st Century workplace.
I will be happy to answer any questions you may have about the
Department of Labor's budget request.
Senator Specter. The balances, which are higher than
expected, would not cover--or would it cover the Youth
Offenders, where there is a reduction of $55 million?
Secretary Chao. The Youth Offenders has been combined with
another program. And I have Jim McMullen, and Jim is the Deputy
Assistant Secretary for Budget and----
Senator Specter. That would be fine. We would be glad to
hear his response.
Secretary Chao. Okay. Basically $20 million has been
injected. The whole program is $75 million over 2 years. That
is the short answer.
Senator Specter. Well, to sharpen my question----
Secretary Chao. I was afraid of that.
Senator Specter. Will the Youth Offenders--we have 5
minutes for Senators. We do have lights for Senators. That is
true.
Secretary Chao. It is an important program.
Senator Specter. Will the program have less money for
fiscal year 2002 than 2001?
Secretary Chao. Yes.
Senator Specter. And----
Secretary Chao. But over a 2-year period, there will be
more. So this has been--the Youth Offender program has been
consolidated with another program, so that over a 2-year
period, there will be more money and there will be no
compromise in the quality of the program.
Senator Specter. What is the other program with which it is
consolidated?
Secretary Chao. May I ask Jim McMullen to take it?
Senator Specter. Yes. That is fine. If----
Secretary Chao. Okay. Jim.
Senator Specter. We are moving into a lot of technical
information and we would be glad to have Mr. McMullen
supplement your answers, Madam Secretary.
Mr. McMullen. What we have pending before you right now,
Mr. Chairman, is a reprogramming request in fiscal year 2001 to
move $20 million out of the Incumbent Worker program into the
Youth Offender program, to make it a program totaling $75
million over the 2-year period, between 2001 and 2002.
Senator Specter. Well, so are you saying that with the
reprogramming, if it is approved, that there will, in fact, be
no cut in the Youth Offender program for fiscal year 2002?
Mr. McMullen. No. That is not what we are saying. What we
are saying is that we are proposing to increase the amount that
you appropriated in 2001 to spread it over a 2-year period. But
there is no new budget authority request for the Youth
Offenders in 2002. That is correct.
Senator Specter. Well, is the program eliminated or simply
cut by $55 million in 2002?
Mr. McMullen. It is not eliminated. It is continued through
2002 by this reprogramming request.
Senator Specter. And what happens after 2002?
Mr. McMullen. We will address that in the 2003 budget.
Secretary Chao. I understand your concern.
Senator Specter. Well--so I am not following. Will the
Youth Offender program have less money in 2002 than in 2001?
Mr. McMullen. Yes.
Senator Specter. How much?
Mr. McMullen. Well, the $75 million is for a 2-year period.
So you had appropriated $55 million. So if you----
Senator Specter. Could you skip the----
Mr. McMullen. If you assume----
Senator Specter [continuing]. The reasons and tell me how
much?
Mr. McMullen. If you assume the $75 million equally spread
over 2 years, it would be $37.5 million.
Senator Specter. It's $37.5 million less?
Mr. McMullen. No. That is a total----
Secretary Chao. No. That is a total----
Senator Specter. Well----
Mr. McMullen. No. That is a total over----
Secretary Chao. Right.
Mr. McMullen. $37.5 million each year----
Secretary Chao. Right.
Mr. McMullen. [continuing]. 2001 and 2002. So----
Senator Specter. Is that the appropriation, or is that the
reduction?
Mr. McMullen. That----
Senator Specter. This is the sixth time I have asked the
question.
Mr. McMullen. The appropriation was $55 million in 2001.
And we are proposing to move $20 million more into it to make
it a $75 million program to be operated over a 2-year period.
If you assumed even----
Senator Specter. So $75 million divided by two is $37.5
million----
Mr. McMullen. $37.5 million, right.
Senator Specter [continuing]. And if it had been at $55
million, that is a $17.5 million cut.
Mr. McMullen. That would be about a--that is correct.
Senator Specter. Which is about a third.
Mr. McMullen. That is correct.
Senator Specter. Well, okay. We have the standing to make
some modifications in it, obviously, but----
Mr. McMullen. That is correct.
Senator Specter [continuing]. That is a danger signal.
And how about the youth activities at $102 million, which
is being reduced in 2002 compared to 2001?
Secretary Chao. If I can ask Mr. McMullen to take a look at
that also.
Mr. McMullen. Yes, sir. We are proposing a reduction in the
youth area, assuming that the reprogramming that we have
pending before you be reduced by about 13 percent from 2001 to
2002.
Senator Specter. So is the figure accurate as provided by
my staff to me, that youth activities will be decreased--second
time I am asking this question--by $102 million in 2002, less
than 2001?
Mr. McMullen. Yes.
Senator Specter. Well, Madam Secretary, on a priority
public policy matter, what is the justification for that?
Secretary Chao. I think the President was trying to ensure
a budget that had fiscal discipline, that was able to meet the
key priorities of our Nation, protect Social Security and
Medicare, and hopefully also put some money back into the
pockets of working men and women in--of America.
Senator Specter. You are not going to tell me that the tax
cut is taking this money. That is going to very materially
weaken the case for the tax cut.
Secretary Chao. Well, this is the beginning of a dialogue
that I am having with the committee. And so what I am learning,
obviously, is the concerns and the priorities of the committee.
And so I appreciate the opportunity to learn about this.
Senator Specter. Well, I really do not think that these
cuts do impact on the tax cut. I just made that comment, when
you say putting money back into the pockets of the taxpayers,
which I think is a good idea.
And we are really looking at an overall budget. And my red
light is on, so I will just make this brief comment and turn to
my colleague Senator Harkin.
We are looking at a decrease in budget which is very
material, $562 million, and when you have an overall increase
that the President has proposed by four percent--and that may
be adjusted upward.
I do not know what is going to happen. The Budget Committee
has not yet concluded its work. And I realize that you have to
negotiate with the Office of Management and Budget. And that is
the executive branch and these figures have to be worked out.
Our interest on the subcommittee level is to try to get, to
the extent we can, the administration's thinking, as we try to
establish a total budget for our subcommittee, which was at
about $108 billion last year; and then how we make the
allocations to all the departments.
But as I take a look at some of these cuts, I think we will
have some suggestions for you.
Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
Madam Secretary, several years ago, the Department of
Labor, at my urging and Senator Specter's, began to--began a
process of taking a look at the use of child labor around the
globe and how that was impacting our country and impacting
world trade.
The Department of Labor, U.S. Department of Labor, has put
out five volumes. I recommend them to you. You do not have to
read every one of them, but I recommend you at least take a
cursory look at those.
Five volumes over the last--how many years? Seven years,
maybe--about 7 years, on various aspects of child labor around
the globe, including child labor in this country. As that
process moved forward, we began on this committee to take a
look at our obligations in the international labor organization
and what we might do to help a program called IPEC, the
International Program for the Elimination of Child Labor.
I felt at that time, and I think a lot of people felt that
the United States ought to stand as a leader, as a beacon to
the rest of the world in terms of eliminating child labor, that
we should not just get along and go along, but that we ought to
take concrete action to help reduce the incidents of child
labor around the globe.
To that extent, this committee and, along with the House,
began to increase funding for that program that is called the
IPEC, the International Program for the Elimination of Child
Labor. And so we started putting money into it. And that went
up to--the final appropriation last year was $45 million for
that, up from $30 million the year before.
Concurrently, along with that, one of the problems that I
have seen as I have traveled around the world and looked at the
issue of child labor in other countries, is the problem of
education, that you cannot just take these kids and take them
out of some of these factories and plants and--surgical
instruments and clothing and things like this, most of whom are
girls, women, young girls, and dump them out.
So the--there is a program that was started that was an
educational aspect of this program to provide support for
educational programs for these children who were taken out of
these plants and out of these factories in some of these
countries.
And so we began a bilateral program with other countries
for education. Now, I have, on my own, seen the results of this
in some other countries and what has happened.
And it really has been startling to see these young girls,
some of them 10, 11, 12 years old, and they have been working
in these plants for 2, 3, or 4 years, since they have been 8
years old. They do not know how to read. They do not know how
to write. They do not know basic arithmetic.
They have been taken out of these plants. They have been
sent to school. They have been given materials. The families
have been given a little bit of a stipend to replace some of
the lost wages.
And if you ever want to have an uplifting experience, go to
one of these countries--I do not need to name them all here--
and just see some of these young girls, who are now 13 years
old. And they can read. And they can write. And they can do
basic arithmetic and math. What has happened to them just in
the last 2 or 3 years has been remarkable.
And so the United States is now taking a lead in this; and
I think for good cause and for good outcomes and to help end
the discrimination that we see around the globe on child labor.
Well, we put $45 million in it last year, into IPEC. We
added $37 million for the education program. Your budget cuts
the IPEC program by, considerably, from $45 million to $30
million, and you eliminate the educational aspect that we put
$37 million in last year. And it cuts 17 FTE's in that program.
Well, Madam Secretary, I think this is a vitally important
program. It is one that we have been making slow progress on
over the last several years through the Department of Labor. I
think the Department of Labor has moved to the forefront of
this.
I believe in the international community, as I have met
with international labor organizations and others, they are now
looking upon the United States as being a leader in the
elimination of child labor and the promotion of educational
benefits for these kids.
I think it really is a step backward for us to try to zero
this out and to reduce the funding for it. And I would just
like to have your comments on it.
Secretary Chao. I would be pleased to. You mentioned
visiting countries in which these child labor practices occur.
I have visited them. I have been with the Peace Corps, and I
have visited many countries. There is no doubt that this is a
serious issue, and we all care deeply about it.
I think the larger issue is whether an office such as
International Labor Affairs Bureau, is able to absorb the money
because in 1996, the budget of the ILAB was about $9 million.
In 2000, the funding was increased to about $76 million. And in
2001, the funding was increased to about $147 million.
That is beyond the capacity of one office to absorb. And
one way obviously to absorb that money is to contract out $70
million of it.
I do not know whether that, indeed, is a responsive way of
doing it, and certainly you can contract out $170 million or
whatever to organizations overseas.
So please be assured that we are not differing at all in
terms of the goal. We want to work with you on this. The issue
is how best to do so, and how we can work and how ILAB can
absorb all this money in such a short period of time. But the
commitment, I assure you, is absolutely there. And we look
forward to working with you on that.
Senator Harkin. Well, I will work with you on it.
All the indications I have is that this money is well
utilized and they could absorb this increase.
I would be delighted if you want to give me some written
documents to show that this money is not being utilized well.
Every indication I got was that it was well utilized and
that they were able to handle this. If you are telling me it
was not, I would like to have some information on that.
I just think to go from $37 million to zero is really
turning it--I mean, obviously they could do more than zero on
education.
Secretary Chao. But the budget of the whole office is the
International Labor Affairs Bureau. I think I was asking for
clarification as to the difference between ILAB and IPEC.
ILAB, itself, under which this program falls, has a budget
of $74 million that went up to about $140 million. So that is a
lot. And I think that was the absorption issue.
Senator Harkin. Over 3 years. That is because of IPEC and
the education.
Secretary Chao. Yes.
Senator Harkin. So----
Secretary Chao. And so a large part of that was just
contracted out. And if you want to build the infrastructure,
internally, that will take some time.
Senator Harkin. But my staff just said--you are talking
about ILAB, but the IPEC program is something that has been
going on for years.
Secretary Chao. Yes.
Senator Harkin. This is not something new. It has been
going on for many years.
Secretary Chao. This is part of ILAB though. And the funds
are fungible.
Senator Harkin. The program, IPEC----
Secretary Chao. Yes.
Senator Harkin [continuing]. International Program for the
Elimination of Child Labor has been going on for a long time.
This is not something new.
Secretary Chao. I have been told it is new. Let me look
into it for you, and clarify that.
Senator Harkin. Well, okay. Just----
Staff. The education part is----
Senator Harkin. Yes. The education part was new. That is
what we started. I look forward to working with you. I just
think it is not right to be backing off on that right now.
Let us see. I just had one other area. According to the
OSHA strategic plan, you specifically cite the Susan Harwood
training grants as one of the main tools your Department
intends to use in OSHA's mission, which is improving workplace
safety and--and health.
These grants provide funding to non-profit organizations to
conduct safety and health training and education in the
workplace.
Yet on March 29, you sent a letter to the 2001 awardees,
informing them that you rescinded the funding, citing budgetary
reasons. One of the grantees, Kirkwood College in Cedar Rapids,
Iowa, had received a $381,000 award. These grants were funded
through the fiscal year 2001 money that this committee
appropriated last year.
Secretary Chao. Yes.
Senator Harkin. So, again, I wonder: What are the budgetary
circumstances that necessitated taking this funding away? If,
in fact--you also said that you specifically cited the Susan
Harwood training grants as one of the main tools. Then you send
a letter out saying that you are going to rescind the funding.
Secretary Chao. Let me backtrack a little bit. These grants
were given on a 3- to 5-year basis. And so the grants were
given basically on the basis of an old budget. In our going
through the budget this time, we found that there was not
enough money.
So let me just also say I have heard a great deal of
concern expressed on this, not only from you, but from other
people. I have received lots of letters. And so that is another
area that I will be looking at.
These grants will not be terminated. We are asking for new
solicitations for a 1-year term. So those grants will go
forward. Instead of the 3- to 5-year time frame that was being
talked about, we are going to go for 1-year grants and take a
look at receiving applications for 1 year.
We are encouraging people, in fact, to reapply. Although,
it will be a 1-year term instead of 3 to 5 years.
Senator Harkin. These grants that went out were not 1-year
grants.
Secretary Chao. No. They were not. They were 3 to 5 years.
And we did not have the funding at that time, which is why we
are going out with a new process.
Senator Harkin. Okay, explain--let's take Kirkwood College
in Cedar Rapids. They had received a $381,000 award. We put the
money into it. We appropriated the money for that program
there.
Now, you write a letter saying ``We are rescinding that
money.'' Why?
Secretary Chao. Yes. Because it was for a commitment of 3
to 5 years that this administration was not ready to commit to
at this point. So we would like to start the program anew and
go out with a 1-year application process.
Senator Harkin. But I mean at least the money that went
out----
Secretary Chao. Yes.
Senator Harkin [continuing]. Why did you rescind that
money? If you want to do something else next year, come in and
do something this year. But as I understand it, you are trying
to rescind this money.
Secretary Chao. Well, people are just restructuring the
program from a commitment of 3 to 5 years to 1 year.
Senator Harkin. So----
Secretary Chao. We are encouraging people to apply.
Senator Harkin. So Kirkwood is going to receive their
$381,000 then?
Secretary Chao. I do not know whether that is a 1-year or a
3- to 5-year commitment, but we encourage them to apply again
for a 1-year grant. And I certainly would understand your
concern with that.
Senator Harkin. My staff tells me that Kirkwood got 1-year
money with the possibility that it could be extended beyond
that.
Secretary Chao. Well, they are, again, invited to apply
again for the 1-year grant.
Senator Harkin. Well, I do not really understand that.
Secretary Chao. Instead of making a commitment for 3 to 5
years, we are saying: This is a new administration. We would
like to have the opportunity to review some of these grants.
But please apply for a 1-year timetable, instead of a 3 to 5.
So that gives us some time to evaluate some of these grants.
And it is not a political process. I mean, the same people
will be going through it, the same career professionals. So we,
in fact, would like people to apply for a new grant, but just a
1-year grant.
Senator Harkin. Well, I will take a look at that. I do not
know. I----
Secretary Chao. And I appreciate your bringing that up to
me. Clearly, you are concerned about that one.
Senator Harkin. Yes. We have got to take a----
Secretary Chao. I am very much aware of that.
Senator Harkin. We have to take a look at that.
Can we go back to ergonomics here for a second?
Secretary Chao. Yes.
Senator Harkin. Last week, I asked how much of the budget
would be dedicated to reviewing the--this whole issue of
ergonomics with this--I--and as I understand, what you are
doing is you are moving ahead to develop a new standard.
You said that there was some problems in the rule. It
needed to be more thoroughly reviewed. Okay. Fine. That is
certainly that is your power to do that as Secretary and this
administration, because the old rule was done away with.
But as I understand from your statements that you want to
move ahead with a new rule, with looking at a new rule and--and
getting information on looking at the problems of the old one.
Okay. If you are going to do that, then it is my
understanding that the budget for the development and
evaluation of Occupational safety standards is cut by $1.2
million. So, again, given your statements that, ``The rule was
problematic. We need to thoroughly review it and come up with a
new rule,'' how can we cut the budget by $1.2 million?
I was asking you also last week how much funding does your
budget allow for review of this issue?
Secretary Chao. Right. The OSHA standards budget is
approximately $14 million. Now, not all of that will be for
ergonomics, because it has not been earmarked. But potentially
all of that can be available. So that is the--the overall pot.
We have an overlay--you know, an overhang of $1.7 billion.
So a lot of that overlay is going to be funding. Because the
cut in the budget is only $562 million, the larger-than-usual
increase in the overhang of unexpended funds is over $700
million.
So that is why I was saying that enforcement will not be
compromised, that none of these programs will be compromised,
because, again, we have this overhang of unexpended funds.
Senator Harkin. My staff informs me that all of that
unspent money is in training, not in OSHA.
Secretary Chao. You are right. I stand corrected.
Senator Harkin. So what--okay. Then we come back to OSHA
again.
Secretary Chao. The OSHA also--some of the decrease also is
because of the cost of living adjustments in terms of FTE's.
Senator Harkin. Well----
Secretary Chao. So that took up some parts of the budget.
Senator Harkin. Again, Madam Secretary, I want to ask you
again, with all due respect, you know, if we are moving--I am
taking you at your word. And I am taking the administration at
its word, since you represent the administration, that you had
problems with the old ergonomics rule, that you want to look at
the problems that were in it, and you want to come up with a
new rule.
Is that my understanding, or am I wrong in understanding
that?
Secretary Chao. No. I have not committed to any course of
action. So I have not committed to a rule.
Senator Harkin. Well----
Secretary Chao. I wanted the opportunity to take a
comprehensive look at this whole issue.
Senator Harkin. So you are not committed to coming up
with--because I--we got into a little bit of a debate a week
ago about a time frame. So now you are telling me you are just
going to look at it.
Secretary Chao. No. I never said that I was coming up with
a rule.
Senator Harkin. So you are not coming up with a rule.
Secretary Chao. I am not dismissing it either. But I have
never said that I was going to come out with a rule.
We have been in office basically since February--or January
20. The C.R.A. did not occur until March 20. So until the
C.R.A., there was an existing rule. So we have had less than a
month.
Senator Harkin. Well, I just--your statement here on March
28 said--you say in your own statement is that, ``However,
musculoskeletal injuries accounted for nearly one-third of all
the injuries. This finding demonstrates the need for a solid
comprehensive approach to ergonomics.''
Secretary Chao. I totally agree with that.
Senator Harkin. But that does not mean a rule?
Secretary Chao. Well, I have not decided yet. I am not
saying there will not be a rule either. I think the responsible
way to approach it is that there is a new team in town. And I
think we have to feel comfortable with taking the appropriate
course of action. And we need to talk with the administration.
Senator Harkin. Well, unfortunately, I wish I knew what
that course of action was going to be. I mean, I have just----
Secretary Chao. Well, I cannot----
Senator Harkin. I mean----
Secretary Chao. I wish I knew as well. But if I did, I
would be working out of a preconceived position. And I said
that I would keep an open mind and that I would talk to
stakeholders, that we would review the past record, that we
would talk to all different groups.
And, in fact, in my previous testimony, I had talked about
certain principles that we would have going forward. And that
was basically to go from a basis of prevention. We all agree
that reducing occupational injuries and musculoskeletal
injuries is our goal. And the question is how best to do that.
And I listed six principles. One is prevention. Two is some
program based on sound science. Three that it be incentive
driven, so employers would really embrace it as well. Four,
some flexibility.
Senator Harkin. Well----
Secretary Chao. ``One size fits all,'' I do not think does
it. Five is feasibility; and six, clarity. So at this point we
have not made a decision.
Senator Harkin. Well, that is fine, but----
Secretary Chao. We are proceeding in good faith to address
this issue.
Senator Harkin. Fine. And every time you are here, I am
going to ask you the same question.
Secretary Chao. I understand that.
Senator Harkin. I am going to try to find out when we are
going to start moving on this.
And, fine, if you do not have a timetable now, well, we
will ask it the next time. And we will see when we are going to
get some timetable and move ahead on this.
Secretary Chao. I understand, yes. I would love to have a
timetable. I think that would be very comforting.
But what we have seen on this issue is that when artificial
time lines are imposed, workers do not benefit. None of us
benefit because----
Senator Harkin. Well, Madam----
Secretary Chao. I----
Senator Harkin. Madam Secretary, also workers do not
benefit when this dribbles along year after year after year,
and nothing is ever done.
Secretary Chao. But we are not talking about years,
obviously.
Senator Harkin. More injuries continue to happen. More
people suffer. And so if I get my druthers, I would rather have
a time line because it forces people to do something and get
something done by a certain time. But if you do not have time
lines, it just dribbles on year after year after year.
Secretary Chao. I understand exactly what you are saying. I
am very concerned about it. If I may just add one last thing,
we had a time line before with the previous administration and
it did not work. So I want to make sure there is not a repeat
of any action that can be reversed.
Senator Harkin. Mr. Chairman.
Senator Specter. Thank you very much, Senator Harkin.
Madam Secretary, on the worker protection line, the
President's budget maintains the activities at last year's
dollar level, but as a result of inflation, there will be a
reduction in staff enforcement.
That leaves less staffing than is in effect for this fiscal
year for OSHA enforcement, mine, safety and health
administration, and employment standards administration.
Is it not, simply stated, a bad idea to reduce staff on
those very important lines of enforcement?
Secretary Chao. I said before--I am trying to answer the
question directly. There is no question that we are for
enforcement. And in looking over this budget, there is no
compromise to the quality nor the intensity of enforcement. We
are going through all of these reductions through attrition.
And also I think one has to make the assumption--one has to
look at whether these positions were the right numbers to begin
with. And so we are committed to going through, looking at the
numbers to see whether this, indeed, is the enforcement that we
need, but there is no lack at all in commitment--in backing
down in commitment on enforcement.
Senator Specter. Well, Madam Secretary, when you say you
are committed to enforcement, there is no showing that there
are too many people in these enforcement lines. And if you
reduce the number, the enforcement is, simply stated, going to
suffer. Well, we will take a look at that too, but that is a
big problem.
We have already gone over the cuts in the job training
programs, the youth program, the Workforce Investment Act, and
the dislocated worker programs. We will review those here.
Let me take up a different subject with you on medical
resident work hours. The Federal Government limits the number
of hours that truck drivers and airplane pilots can work, among
others. And there is a big issue on medical resident work
hours, where physicians work up to 80 hours a week, without a
day off, and sometimes more than that.
And there is a good bit of evidence accumulating about
sleep deprivation associated with these long hours resulting in
automobile accidents, depression, and giving birth to premature
infants. I am reading a list of the factors, which have been
called to the subcommittee's attention.
And then you have the basic problem of people who are being
treated by these residents who are, simply stated, groggy, and
simply cannot perform.
There was a petition filed on April 30 to OSHA from
healthcare professionals seeking a Federal limit on the number
of hours medical residents can work. What do you think?
Secretary Chao. I just learned about the petition on
Monday, so I have not had an opportunity to review it.
Obviously, if the Chairman is concerned about it, I am
concerned about it. And I will take a----
Senator Specter. Well, perhaps we ought to have a hearing
on that specifically. I realize that it has just been filed and
there is always a reluctance to increase Federal jurisdiction.
Especially when you talk about hospitals with the Balanced
Budget Act, their economies and sort of an unwritten code that
if you want to be a high and mighty doctor, you have got to
suffer a lot going through on the resident process, and the
argument is made that they make up for it later.
But this is a real problem for those who are going through
it. And it is a real problem for people who are in hospitals
that received their services.
Secretary Chao. I might also add, probably we have to talk
to HHS about this as well.
Senator Specter. Turning to still another subject, there
has been a long-standing problem with the Amish--a good many of
whom are in Lancaster County and are constituents of mine--on
an effort to have Amish youth, 14 to 18, work in sawmills.
The House of Representatives has twice passed legislation
to allow that. We have had legislation pending in the Senate,
which I have introduced. What I would like you to do is to take
a look at that.
It is a fairly involved and fairly technical subject,
unless you already have a view on it. Tell us what you think
about that.
Secretary Chao. I am very sympathetic. And, obviously, as I
have said before, concerns by members resonates strongly with
me. I will take another look, but the preliminary response that
I have gotten from Wage and Hour is that this has to be a
legislative fix.
Senator Specter. It has to have a legislative fix?
Secretary Chao. Yes, and that they do not have very much
flexibility in reinterpreting that.
But on the other hand, I do not have my solicitor in place
or lots of other people in place. I will take another look.
Senator Specter. Well, take a look. It is a little early
for you to really be expected to have a comprehensive view of
that, but it would not be unkind to say that it may be a
bureaucratic response to say there has to be a legislative fix.
Secretary Chao. Well, I am hoping that, you know, as I get
my team staffed up, that we will be more responsive, and we
will be able to answer a whole host of questions.
Senator Specter. The President has a lot of discretion. And
he has delegated that discretion to the Secretary of Labor, so
let us take a look.
Secretary Chao. I will do so.
Senator Specter. I think administratively would be a much
better way to handle that.
My red light is on again. So I am going to yield to my
colleague.
Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman.
And, Secretary Chao. Welcome. It is good to have you here,
and I am--let me just say at the beginning, I am encouraged by
what I see in your Department's proposed budget.
Increasing funding for the Department by $5.2 billion, I
think, is a positive sign in providing adequate resources for
programs like Job Corps and funding for the Office of
Disability Employment Policy and other critical assistance
programs, I think, is essential.
I am concerned, however, about some of the decreased
investments for job programs that help at-risk youth and funds
employment and training activities for dislocated workers.
And let me start by asking you about at-risk youth. I think
we all know that the job requirements, the education
requirements, the training requirements for our work force have
changed dramatically in the last decade. And today, more than
ever, our workers need more education and training to develop
the skills they need for the--the jobs that are out there
today.
And I am really very concerned that your budget provides
$222 million less for youth employment and training programs.
We cannot leave young people out of our country as we move
forward. And I would appreciate it if you would address that
cut in your budget.
Secretary Chao. There is no commitment, obviously, to
backing away from helping youths at risk. It is an issue that I
feel strongly about, and I have worked with in the past.
I mentioned before that there was about $1.7 billion in
unexpended funds. And the usual carryover is about $1 billion.
So we have an extra $700 million. The cuts from the budget is
only about $562 million. So the carryover still takes care of
the overall reduction.
The youth carryover is about $480 million, so we can
maintain the service levels.
Senator Murray. The carryover from last year's budget?
Secretary Chao. So we, again, do not expect any diminution
of service or commitment, obviously. But that we believe that
we can maintain the service levels.
Senator Murray. Were those funds that were appropriated and
not spent?
Secretary Chao. Yes.
Senator Murray. I hope then that you have a commitment to
make sure that those grants and opportunities move out there
for our young people. There is a high increasing demand for
that.
Secretary Chao. We will do so.
Senator Murray. Okay.
Secretary Chao. And there is also a reprogramming request
of $20 million that makes for a 2-year budget request of $75
million. So we went over that a little earlier. But
participants will not go down because, again, the number of
participants will not go down and the quality of the program
will remain undiminished.
Senator Murray. I think it is--good. Yes. I think it is
really important that we emphasize that we do not want to see
our kids on the street with no skills.
Secretary Chao. Yes.
Senator Murray. Second, I am very concerned about
dislocated workers. In my end of the country, we have seen a
lot of dislocation, unexpected, in the last year or two,
particularly with the current energy crisis that has shut down
some of our mills and aluminum companies and threatens more,
very--in the very near future. We have seen over 2,000 layoffs
at this point and we will be seeing more.
Boeing has had some layoffs. Our high-tech industries are
not employing and--and having layoffs. And I am very concerned
that your budget has decreased adult employment and training
programs by $257 million.
I think the demands for these dislocated workers are
increasing. And if you could address that, I would appreciate
it.
Secretary Chao. There is also some talk about a softening
economy, so this is obviously an area that we are concerned
about. We want people to be able to find assistance.
The dislocated workers program, again, is one of those
programs that we do not expect any diminution of service nor
quality, because of excess funds from the previous years.
I know that in your particular State, you have got special
concerns. And I will be more than glad to work with you on
those concerns, as well.
Senator Murray. Okay. I would really appreciate your doing
that, because we are seeing a lot of dislocation. We are going
to see more. And we want to make sure that these people land.
So I would very much like to work with you on that.
In a place where we are seeing a lack of workers is the
nursing shortage that we are currently seeing that I am very
concerned about. Our healthcare facilities, our long-term
facilities are very concerned about the lack of healthcare
workers that are coming into--into that.
And we are currently working in the Senate now on
legislation to provide $500 million a year for the next 3 years
in grants to States to promote the nursing profession and to
help long-term care providers, to recruit and train and retain
caregivers at all levels.
Would you be supportive of that kind of an approach?
Secretary Chao. I have talked a lot about the skills gap. I
think this is clearly one example. So I have set up a new
office called the 21st Century Workforce. And this is one of
the areas that we are going to address, for example, at the
summit that we are holding on June 20, and as we go forward as
well.
Senator Harkin. Okay. Well, Secretary Thompson testified
before the committee last week that part of the solution might
be tied to allowing more foreign nurses and healthcare workers
to immigrate to the United States to help fill that void.
Would you be willing to work your Agency with his to talk
to the Department of Justice and Immigration and Natural
Service to try and enact something like that?
Secretary Chao. We would be interested in exploring this
option further with him.
Senator Murray. Okay. I think it is important that we look
at all ways to meet that need.
Secretary Chao. Right.
Senator Murray. So I encourage you to do that.
On an entirely different topic, I want to talk about
asbestos for a minute. Most people in this country think that
asbestos has been banned and they do not have to worry about
it. But asbestos has not been banned in this country and in
some cases, it is still being used to manufacture automotive
brakes and roofing materials.
And we are seeing it show up in consumer products like
crayons, garden fertilizers and insulation. Because asbestos is
a contaminant found in deposits of other minerals, that is why
we are seeing that.
Evidence has suggested that workers have died from
exposure. The case in Libby, Montana, where 192 people have
died has been very prominent in the news. And 375 people are
currently suffering from fatal diseases caused by that
exposure.
I was curious whether you were familiar with the Inspector
General's report on MSHA's handling of inspections in the mine
in Libby and with the recommendations that are in that report.
Secretary Chao. The I.G. has handed that report to me
about, I would say, 3 weeks ago. We are in the process of going
through that.
I do not have an MSHA administrator yet. He has been
announced and nominated. We hope that he will be confirmed
soon, so that he can tackle this issue as well.
Senator Murray. Well, when he is in place or even before, I
would like to work with your Agency to make sure that we
address that and implement the recommendations that require
rule--rule-making as quickly as possible.
And I see that my time is up. Thank you.
Senator Specter. Thank you very much, Senator Murray.
Senator Harkin, do you have one more question or----
Senator Harkin. Just one more question.
Just picking up on what Senator Murray was talking about on
the employment and training money that you said there was this
carryover. First of all, I understand that the amount--that
even though you have a large carryover, the amount varies per
State.
Secretary Chao. Yes.
Senator Harkin. And so dislocated worker funds go to States
on a formula basis.
Secretary Chao. Right.
Senator Harkin. Therefore, every State will take the same
percentage cut even though some States may have a big carryover
and some States may not have much carryover.
Well, here is the point I am getting to: My staff at my
direction requested an analysis, because I wanted to know what
was happening in Iowa, obviously, my State. I wanted an
analysis of the unexpended carryover funds in employment
training programs by State. About a month ago, my staff
requested this breakdown by State.
They were told by your staff that a table--there was a
table. We have asked repeatedly as late--as late as yesterday
to get this, but your Department will not release it. So I am
asking: Will you release to me the information that will allow
us to understand the impact on the cut to my State--and our
States?
Secretary Chao. I see no reason why you cannot have that at
all. So I am not aware of that request. But you will have it.
Senator Harkin. If you can get that, because I would like
to see, because it does vary State by State.
Secretary Chao. Sure.
Senator Harkin. And if you are going to take a cut that is
percentage, some States may be fine. Some States may not be
fine. And I think we, as appropriators, need to take a look at
that. And I would appreciate it.
Secretary Chao. I think that is a very reasonable request.
Senator Harkin. I appreciate it. Thank you very much, Madam
Secretary.
Thank you.
Senator Specter. Thank you. Thank you, Senator Harkin.
Madam Secretary, the hearing that we had on last Thursday
on ergonomics showed a very, very deep split between some
segments of the business community and those representing the
workers.
And I know your schedule precluded you from attending the
full hearing, but we have given you the transcript. We ordered
expedited transcripts so that we could take it up today.
Do you think that there is any realistic likelihood that
there can be a consensus on an ergonomics rule?
Secretary Chao. No, I do not; 100 percent consensus, no.
But I think there has to be some critical mass upon which to
move forward because without that critical mass, I do not think
any program is going to be successful.
So I am keeping an open mind and I do not have any
preconceived notions. I am keeping all options open. As I
mentioned in my letter, it may include rulemaking. I have not
ruled anything out. I have not made a final decision.
We have only had since March 20 when the C.R.A. was pleased
to take a look at this. And I can assure you that we are
proceeding with full speed and with absolute seriousness and
intent to try to address the ergonomics and musculoskeletal
injuries.
Senator Specter. When you say that you are proceeding at
full speed, precisely what are you doing?
Secretary Chao. We are meeting with--well, this is a new
team also. And I think we need to be given time to, No. 1, meet
with the shareholders, and go through the past record.
In terms of making up a new rulemaking, we cannot go back
to the previous record and draw--well, there is some question
as to whether--and you know better than me. There is some
question as to whether we can go back to the previous record
and just utilize the information of the previous record,
because there were issues expressed about, not only the
substance, but also the process.
So I think at the very start, we need to go back and talk
with all the stakeholders. I think we have done a good job. We
have met with multiple groups in an effort to listen to
everyone, first of all, and then try to craft some program for
moving forward that will not be stymied right from the outset.
Senator Specter. Well, Madam Secretary, I think it is
reasonably clear that you can go back and look at the
information which was compiled before.
Secretary Chao. Yes.
Senator Specter. You are going to have to satisfy yourself
as to an evaluation of it and to have an opportunity for people
to comment about it. But you can take a look at what has been
presented in the past.
Secretary Chao. That is true.
Senator Specter. This subcommittee wants to, in its
oversight capacity, monitor what you are doing on a time line.
I take it from your response to Senator Harkin's question
that when I asked you to go back and take a look to see if you
could give us a time line or a concluding date, that you have
thought about that but do not think you can give us a target
date.
Secretary Chao. I would love to, if I could, but I just do
not think I can. I do not think that is a responsible way to
approach it. I am not going to drag this out. I can assure you
of that. But I think for me to come out with a deadline would
be very irresponsible.
Just to let you know, we have met with United Commercial
Food Workers. This was in my testimony last time. We have met
with the AFL-CIO, Service Employees International Union, United
Brotherhood of Carpenters and Joiners. We met with a lot of
labor groups, a lot of--American Occupational Therapy
Association, Food Marketing Institute, certainly on the other
side, American College of Occupational Environmental Medicine.
So we are conducting our due diligence in meeting with
these various groups. We are going back to the record. There
were 11,000 comments on the old rule in just a 12-month period.
We are not obviously going to go through the whole thing, but
there have been criticisms of the process.
And while we can go back, obviously, and take a look at the
previous record, there has been some criticism as to whether
that record is inclusive of other types of information.
And also there have been concerns about--comments were
submitted by citizens, you know, that were farmed out, paid
outside consultants. I mean, this is pretty--this is a very
complicated issue. It is very complex.
I am not interested in slowing it down, but I do want to do
it right. And, again, I want to do it right because we have got
to do the right thing; otherwise, another overturned action can
occur. And I am not so sure that benefits anyone.
Senator Specter. Well, I daresay that something that the
Bush administration comes up with is not likely to be
overturned. The action by the Congress was highly unusual. And
I supported overturning the regulation, because I thought it
was excessive and others did too, where there were some
expressed commitments made by legislators, by Senators that
there would be a new rule.
Now, they do not bind you, but this is something we will be
talking about within the Senate, where we have a lot of
experience on this issue. And the people who were strenuously
opposed the rule were able to persuade a number of us to vote
to overturn that rule on the representation that there would be
a new rule.
Now, I understand the articulation you have made. And they
do not bind you, but we are all players in the process, and we
all have a role in the process. And those who made those
representations to secure votes on the Senate floor have some
impact and some weight.
Let me raise a question as to your use of the term
``irresponsible'' to come up with a----
Secretary Chao. Well, let me answer the previous point. If
other people have made representations, then those are the
people that should--that should be--that this matter should be
discussed with.
I stated very plainly in my letter that I was not ruling
out rulemaking, but I was not committed to it either. So,
again, if there are other people who made other
representations, then they should be talked to.
Senator Specter. Well, you can bet they are being talked
to. You can be sure of that.
I have already made it abundantly clear that I understand
they do not bind you. There is this doctrine called
separation----
Secretary Chao. I am very interested in having a good
relationship with this committee and especially with the
chairman and the ranking, so I hope you will realize that I
will--I am looking at this from a long-term point of view. I
would never play any short-term games or anything like that.
And I hope that you understand that.
Senator Specter. Well, I was about to say I understand the
doctrine of separation of powers and that you are an Article II
officer, and we are Article I officers. And we do not really
rate very high anyway.
Secretary Chao. That is not true at all, not----
Senator Specter. Since----
Secretary Chao. You rate very high in my book.
Senator Specter. Since Marbury v. Madison, neither Article
I nor Article II officers rate very high. The Court decides
everything these days.
But I was starting to raise a question about the use of the
word ``irresponsible.'' To say that it would be irresponsible
to accept a time line when the subcommittee is pressing for a
time line, I question that characterization.
I do not think we are asking for something which is
irresponsible. There is----
Secretary Chao. I think that it is irresponsible on my
part. It is not to say that there is any--that is not to
attribute that to anybody else but me.
Senator Specter. Well--but if the subcommittee is asking
for a time line, and a time line is irresponsible, somebody
might raise the inference that we are asking for something
which is irresponsible. So I just----
Secretary Chao. And I certainly did not imply--I did not
mean to imply that.
Senator Specter. I just question the use of the word
``irresponsible.'' Unrealistic, impossible, difficult--
``irresponsible'' is a word that has a lot of----
Secretary Chao. I will use one of the other words from now
on.
Senator Specter. I know you are familiar with Senate bill
598, which proposes legislation to establish a time limit of 2
years for the enactment of a rule. What do you think about
Congress telling you that you have 2 years to make a rule?
Secretary Chao. I know that you are a co-sponsor of that.
Senator Specter. Senator Harkin is not, though. He is still
safe.
Secretary Chao. I know that you are a co-sponsor of that
and, obviously, we are very cognizant of the amendment. We are
working with--we would like to work with Senator Breaux and the
sponsors on this.
A 2-year time frame, as told to me by the career
professionals in the Department, is unrealistic. It is very
hard to say pro forma how long a particular rulemaking would
take. But 2 years for this kind of rule seems overly ambitious.
But, again, we want to be in discussion on this issue.
Senator Specter. Well, okay. I mentioned the bill, because
the Breaux bill does set a time limit. And it is possible that
bill could be enacted.
And my preference would be not to have the time limit come
from the Congress. My preference would be to have the time
limit come from the Secretary.
So I would ask you, on behalf of the subcommittee and the
committee and the Senate and the Congress to take another look
at this issue to see if you cannot give us some idea as to how
long it is all going to take.
Secretary Chao. I will certainly do that. Let me also say,
you know, given all the pressure that I am under, it would be a
lot easier for me just to give a deadline. It would make my
life a lot easier. It would make a lot of--certainly, would
make my life a lot easier.
But I have been there for, again, for 3 months. I want to
do the right thing. I do not have an OSHA administrator yet. I
have only got two people that are confirmed in the Department.
You know, Mr. Harkin was talking about responsiveness from
the Department. The career professionals are wonderful. I
devote a great deal of time cultivating the relationship with
them. But we are a new team. We want to be responsive. We are
not there yet. I fully understand that.
But as we get staffed up, as we get more familiar with some
of these issues, I hope that you will think that we are
responsive as well.
But, again, let me say, from a personal pressure point of
view, it would be so much easier for me to say, ``I can give
you a deadline.'' But, again, I do not think that that is
something that will benefit any one of us in promulgating a
truly good program.
So let--and as I have said before, I want to work with you
and also Senator Breaux on this amendment. And so my staff, I
believe, has been talking to all of you. And I would hope that
that will continue.
Senator Specter. Madam Secretary, we have taken a look at
the plans at Levi Strauss, Xerox, Consolidated Edison, United
Auto Workers, all of which have put ergonomics programs into
effect with very beneficial results.
One of them, Xerox, had a 24 percent decline in the number
of worker's compensation cases. So we would commend to you what
is going on in the private sector as a model.
Secretary Chao. Yes.
Senator Specter. And we understand UPS also has done some
good work. And we have written to UPS. And the point was made
that some of the companies have not responded to the Department
of Labor, like UPS, on giving them the benefit of their
thinking and their successes. And this subcommittee is in a
position to help you. Do you----
Secretary Chao. Well, I appreciate that.
Senator Specter. Do you know if you have the subpoena power
to compel, say, a company to come forward and tell you what
their experience has been?
Secretary Chao. No, I do not. But I think that is a pretty
bad example, if we have to compel them. I am not so sure their
results were--what--are ones that I want to hear.
Senator Specter. Well----
Secretary Chao. We are looking at best practices and we are
interested obviously in finding out what the private----
Senator Specter. Well, if a company does not respond to
what their experience has been, the Congress is not reluctant
to issue subpoenas. And I do not know what----
Secretary Chao. I will certainly find out if we do have the
authority to do that.
Senator Specter. I do not know whether you do, but this
subcommittee would have no reluctance to find out what
companies are doing.
Secretary Chao. I have no reluctance either. I was making a
little bit of a--of levity, which was probably not appropriate.
But I was going to say that if they did not want to share their
results, I am not so sure they are worthy to be shared. But
your point is a very good one about the subpoena.
Senator Specter. Well----
Secretary Chao. And I will find that out.
Senator Specter. Well, I do not know that UPS has not
responded. That representation was made. Whether it is so or
not, I do not know. We are making an inquiry.
Secretary Chao. And we are talking to other companies on
best practices.
Senator Specter. Okay. But these companies which have
experience, which would be useful to the Department of Labor, I
expect them to make it available.
Secretary Chao. Yes.
Senator Specter. And if they do not, this subcommittee has
subpoena power. And I have had some experience at issuing
subpoenas----
Secretary Chao. Yes.
Senator Specter [continuing]. And effectively. So I want to
help you.
Secretary Chao. Thank you.
Senator Specter. Madam Secretary, we are going to give you
some questions from Senator Stevens for response in the record.
My final question to you--or let me not put it in the form
of a question.
I would like for you to give this subcommittee a periodic
report as to what you are doing, since we have not gotten to
the point of a time line. I would like you to let us know every
90 days, if that is not too burdensome. I was thinking about 60
days, but let us make it 90 days, if you could give us a brief
summary as to what you have done on the ergonomics issue.
Secretary Chao. I would be delighted to.
Senator Specter. Okay.
Secretary Chao. Let me--may I also add one last thing?
Senator Specter. Sure.
Secretary Chao. Going back to the Youth Offenders program,
let me also take another look at that, because my understanding
was that the participants would not go down because of the
carryover funds. And so if that is not the case, then I will
take a look.
But that--my understanding was that the quality of the
program was not going to be diminished, and number of
participants will not go down--again, because we had this
excess funds. But if that is not the case, I will get----
Senator Specter. Well, that is an especially important----
Secretary Chao. I will get back to you on that.
Senator Specter [continuing]. Important program. When you
talk about rehabilitation, if we do not do it with the Youth
Offenders, it is just a revolving door and recidivism. And that
is a critical point of intervention.
Secretary Chao. Right.
Senator Specter. So I appreciate your taking another look
at it.
Anything you care to add, Secretary Chao?
Secretary Chao. I think that is it. Thank you for having
me.
Senator Specter. Mr. McMullen, I will give you more of a
speaking part here.
Mr. McMullen. Nothing to add, sir.
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
companionship services
Question. What is the Labor Department's plan regarding the Clinton
Administration proposal to change the rule on ``companionship
services'' under the Fair Labor Standards Act, specifically regarding
an analysis as to the impact on the elderly and the disabled?
Answer. The rulemaking proposal was published on January 19,
inviting comments for 60 days. Because of the continuing interest
expressed in the proposal and in response to requests, on April 23 the
Department reopened and extended the public comment period for 90
additional days (until July 23). The background and history to the
statutory provisions covered by this rulemaking, as well as its
perceived impact on recipients of companionship services, will be
carefully reviewed. In addition, all public comments received on the
proposal during the extended comment period will be given very careful
consideration before reaching any final decision in this matter.
Question. Regarding the proposed rule on companionship services,
has the Department given full consideration to the impact of the change
on Federal and State programs that pay for much of the care that will
be affected by the proposal? If the costs to provide the care go up,
will the costs go up to the Federal and State programs that pay for
these services?
Answer. HCFA previously estimated that the proposed rule would have
a negligible effect on Medicare costs, as this service is not a
significant component of Medicare. Annual Medicaid program expenditures
may increase somewhere within a $30 million to $40 million range, of
which 57 percent would be the Federal share. Assuming an equivalent
magnitude of increase in the private sector would suggest the maximum
possible combined (public and private) increase of no greater than $75
million. (See preamble of regulatory proposal, at 66 Fed. Reg. 5486,
January 19, 2001.)
Question. If this rule is implemented, will it exacerbate the
shortage of this workforce as workers may be restricted to less than 40
hours per week to avoid obligations for overtime compensation?
Answer. Implementing the proposed rule is not expected to
exacerbate any workforce shortage in this industry. To the contrary,
improving the wage structure to include minimum wage and overtime
protections may contribute to attracting additional workers to this
industry.
Estimates from the home care industry indicate that most workers in
this industry are not working overtime hours, on the average. The data
also indicate that there are many low-wage workers in this industry.
harwood grants
Question. I am troubled by your Department's recent decision to
withdraw a number of OSHA's ``Susan Harwood'' Grants. This action will
have a significant negative impact upon efforts nationwide to curb
devastating workplace injuries. Particularly, I am advised that the
Graphic Communications International Union Locals within Pennsylvania
will lose a grant for $296,000 per year for five years and would be
forced to stop offering their members training via the safety and
health program that is now being funded by this grant. Please provide
me with your justification for withdrawing these grants.
Answer. I can appreciate that there are disappointed groups in your
State. The Pennsylvania Foundry Association in Plymouth Meeting,
Pennsylvania, was affected by the decision to rescind the grants.
However, the funding for the Graphic Communications International Union
Locals is unaffected. They were not one of the 19 groups whose grants
were rescinded.
In reference to the decision affecting the 19 groups: we did not
believe that we should commit to higher cost long-term grants of 3 to 5
years. These grants, which were approved during the last month of the
previous Administration, are larger and longer-term grants than have
typically been awarded under this Program. In choosing among many
competing priorities for funding, the Department concluded that it was
preferable to provide targeted, short-term grants and maintain
Departmental flexibility to respond to emerging safety and health
issues. Therefore, OSHA will revert back to one-year grants in targeted
subject areas.
We published a new solicitation under the Susan Harwood Training
Grants program on April 18, 2001. Grants will be tailored to provide
short-term targeted training in: (1) construction; (2) bloodborne
pathogens; (3) ergonomics; (4) electrical power generation; and (5)
training programs for hard to reach workers. We have specifically asked
prior applicants to reapply for grants under the new solicitation. I
will ensure that, in fiscal year 2001, OSHA awards fully the $11.2
million available for training and education grants. These grants will
be geared to our team's strategic plan and new approach to safety and
health of the Nation's workers.
As I stated when I was sworn in, ``If we are going to protect
workers, we must put more emphasis than ever before on prevention and
compliance assistance--rather than just after-the-fact enforcement.''
As you know, the Harwood Training grants are but one of many compliance
assistance tools used by OSHA. Others include on-site consultation,
training provided by the OSHA Training Institute and its affiliates,
and easy-to-use interactive electronic tools to help employers and
workers understand and comply with OSHA standards.
office of the 21st century workforce
Question. Tell us about your plans to create, with existing funds,
a new ``Office of the 21st Century Workforce''. Where will the funds
come from to create this new office? What do you anticipate this new
office will accomplish?
Answer. The mission of the Office of the 21st Century Workforce is
to ensure that every worker has the opportunity to pursue fulfilling
and financially rewarding careers and to make sure that no worker
becomes a casualty of the global economy of this new millennium. Its
initial mission is to address our current skills gap and worker
shortage. Funding for the permanent staff of the Office is from the
Office of the Secretary's Departmental Management account.
transitional living program
Question. You are requesting $8.3 million for a new grant program
to assist persons with significant disabilities in making the
transition from institutional settings to the community and employment.
This sounds very much like the $50 million program of the Health Care
Financing Administration at the Department of Health and Human
Services. Are there are any differences?
Answer. Yes, the two programs are different in that they would be
focused on providing different types of services even though they are
focused on the same target group--individuals with disabilities who are
making the transition from institutional settings to the community. The
two programs would be designed to complement, not duplicate, each
other.
The Department of Health and Human Services' (HHS) $50 million
grant program is for support services. These grants will promote the
design and delivery of home and community-based services that support
people with a disability or long-term illness to live and participate
in their communities. The HHS grants will focus on meeting housing
needs, personal assistance, expanding public-private partnerships to
meet long-term needs, technology, and technical assistance. The United
States Supreme Court's Olmstead decision, which is the basis for the
HHS grants, clearly holds many implications and opportunities with
respect to employment opportunities for people with disabilities.
However, the HHS grants do not specifically target the employment and
vocational needs of individuals transitioning from institutions to
their communities.
The proposed $8.3 million for a DOL Olmstead grant program would
support the educational and professional development of individuals
with disabilities. The grant program would provide funds to build
professional competence within the workforce system to be able to
effectively partner with other systems so that movement of people from
institutions to the community includes planning for their employment.
We plan to work closely with HHS and other relevant agencies, such as
the Department of Education and the Department of Housing and Urban
Development, to coordinate with and complement their efforts.
information technology (it) cross-cut budget
Question. You have requested more than double the funding of
information technology at the Department of Labor from $37 million to
$80 million. What do you anticipate that increase in funding will
accomplish? Is this increase in funding to be expected in subsequent
budgets?
Answer. The central IT fund comprises cross-cutting initiatives to
comply with laws like the Clinger-Cohen Act and which benefit the
entire Department. These initiatives fall into four categories:
Security and Privacy.--This necessary component includes security
planning and plan implementation, risk management and mitigation,
contingency planning, installing firewalls and intrusion detection
systems, and related support contracts.
Enterprise Architecture.--This focuses on upgrading the
Department's outdated core infrastructure, a necessary step to
implement the Department's IT Architecture. Investments will be made in
Local Area Networks (LANs), software, cabling, and telecommunications
equipment.
Common Office Automation Suite.--This moves the Department to a
single suite of office automation tools (word processing, spreadsheet,
graphics, e-mail, database) to permit full interoperability among DOL
agencies.
Common Administrative Systems.--We must also address applications
that are used by most or all DOL agencies, such as Human Resources,
Payroll, Travel, and inventory management functions.
Together, these initiatives are designed to ensure an integrated,
Department-wide approach to IT investments in support of the
Department's missions, goals, and objectives. Compliance with Section
508 of the Rehabilitation Act also has been built into the IT cross-cut
budget. The initiatives are managed in accordance with DOL's IT capital
planning and investment control process.
The increase in funding will support an IT infrastructure capable
of supporting E-government objectives, the implementation of our common
office automation suite strategy, a more secure IT environment in
accordance with the Government Information Security Reform Act, and
implementation of applications supporting enterprise-wide
administrative functions such as financial and human resources. The
only department-wide IT fund, this approach has been identified as a
``best practice'' by the Office of Management and Budget (OMB).
These IT improvements are ongoing initiatives and are essential to
help the Department be as responsive as possible to the needs of
workers and to secure its data and IT resources. We have not, however,
made decisions on future budgets.
osha, msha and esa staff reductions
Question. Your budget request would maintain funding for OSHA, the
Mine Safety and Health Administration, and the Employment Standards
Administration at essentially current levels. Due to the impact of
inflation, this would reduce staffing at OSHA by 94 full-time
equivalent positions, 47 mine safety positions, and 93 jobs at the
Employment Standards Administration. Is this justifiable? Are these
agencies currently overstaffed? Is it your intention not to hire the
additional enforcement staff approved by Congress for fiscal year 2001?
Answer. Worker protection budgets have increased significantly
during the last 5 years. While worker protection continues to be a high
priority for the Department, we have, in the interest of responsible
budgeting, carefully reviewed each agency's FTE needs with an eye to
eliminating unnecessary management layers and inefficient work
processes. The budget proposes to redirect these resources to higher
priority areas like front-line service delivery.
OSHA, for example, has reviewed its current organizational
structure to look for completed activities or those functions which are
better integrated into the front-line work of the agency. Overall, the
fiscal year 2002 budget reflects a reduction of 94 FTE--42 management
FTE and 52 FTE associated with the previous Administration's re-
invention initiatives. Since OSHA is not reducing safety and health
compliance officer staffing, the agency plans on hiring all of the
additional enforcement staff approved by Congress in fiscal year 2001.
The three ESA enforcement programs anticipate a slight reduction in
enforcement staff in fiscal year 2002. Approximately 60 percent of the
reduction in the enforcement programs will be taken in overhead staff,
which comprises about one-third of the total enforcement program
staffing. A reduction of 93 FTE amounts to approximately a 2 percent
reduction in staffing and most, if not all, of that can be absorbed
without negative consequences for enforcement. Within ESA, the Office
of Workers' Compensation Programs anticipates employing the same number
of claims examiners in fiscal year 2002 as in fiscal year 2001 for the
Federal Employees' Compensation, Longshore and Harbor Workers'
Compensation, and the Black Lung Compensation Programs.
With respect to MSHA, during the past five years, the number of
coal mine enforcement FTE remained roughly level even as the number of
coal mines decreased by 19 percent. Given this situation, the Agency
believes that it can absorb the 47 position reduction in FTE in the
coal program without compromising worker safety. MSHA fully intends to
hire the additional 40 FTE approved by Congress for the metal and
nonmetal enforcement program in fiscal year 2001.
cuts in workforce programs
Question. You have proposed reductions for programs authorized
under the Workforce Investment Act due to the slow expenditure of funds
in the first year of implementation. Do you think it is possible that
demand for those funds may increase in the next fiscal year since many
States and communities are now planning and implementing programs based
on that funding? If so, is it wise to scale back these programs at this
time?
Answer. In projecting expenditures for the remainder of Program
Year (PY) 2000 and PY 2001, and budget needs for PY 2002, DOL assumed
that State Workforce Investment Act (WIA) programs would be fully
implemented by June 30, 2001. DOL also projects State expenditures in
succeeding years will be greater than would have been possible had
unexpended balances not increased last year and during the first six
months of this year. There will be no scaling down of programs
nationally as a result of the reduced request for PY 2002. In fact,
total spending for WIA State programs is estimated to be $174 million
more in PY 2001 and in PY 2002 than the PY 2001 budget authority.
Question. How would the proposed cuts affect those States and
communities that are fully spending their funding allocation? Have you
heard from any of these groups since your budget proposal was released?
Answer. DOL staff regularly and routinely speak with States, local
communities and their representatives. There is widespread
acknowledgment that spending has been lower than expected and that the
causes are many. In fact, through mid PY 2000, only two States
(Delaware and Vermont) had spent more than 50 percent of the funds
available to them in PY 2000. Federal, State and local partners have
joined forces to review the causes and work together to propose policy
changes and assistance that would address the issues.
A few communities might find themselves with fewer resources as
allotments are reduced and they do not have as large an unspent balance
as others have. However, we believe that underspending is widespread
and the number of communities that are fully using funding are few.
Most communities will find themselves with sufficient carry-over from
earlier years to offset reduced allocations. For those few that do not
have substantial carry-in, we would hope the impact of the proposed
reductions can be ameliorated, in part, through reprogrammed monies to
the youth formula program in 2001, State reallocation of funds among
local areas, State targeting of funds available for Statewide
activities, and Federal award of National Emergency Grants.
With respect to the latter, Dislocated Worker funding is provided
to States and local communities by formula; the Secretary maintains a
reserve of 20 percent of total Dislocated Worker funding, most of which
is used for National Emergency Grants. These grants are available to
States and local communities which have fully spent their formula funds
and find themselves needing additional allocations for Dislocated
Worker assistance. As a result, we do not expect dislocated workers to
be denied services as a result of the small reduction requested for the
program.
worker layoffs
Question. In light of the recent sluggish economy, what kinds of
worker layoffs do you expect in the next fiscal year?
Answer. There were 1,445 mass layoff actions in April 2001 as
measured by new filings for unemployment insurance benefits during the
month, according to data from the Bureau of Labor Statistics. Each
action involved at least 50 persons from a single establishment, and
the number of workers involved totaled 175,064. In January 2001 through
April 2001, the total number of events, at 5,995, and initial claims,
at 719,781, were higher than in January-April 2000 (4,889 and 535,327,
respectively).
In April 2001, manufacturing industries accounted for 42 percent of
all mass layoff events and 44 percent of all initial claims filed. A
year earlier, layoffs in manufacturing accounted for 34 percent of
events and 32 percent of initial claims. Manufacturing industries with
the highest number of initial claimants were transportation equipment
(12,583, mostly in motor vehicles and car bodies), electronic and other
electrical equipment (11,552, largely in semiconductors), and
industrial machinery and equipment (11,312, primarily in farm machinery
and equipment). Services accounted for 25 percent of events and 28
percent of initial claims filed during the month. Layoffs in services
were highly concentrated in business services (particularly in help
supply services, which accounted for 12 percent of the total number of
initial claimants). We also have seen a significant upswing in trade
petitions for last five months.
With the slow economy, we expect this trend to continue through
part of the next fiscal year.
However, the unemployment rate remains low, meaning that many
dislocated workers are able to find new employment with little or no
governmental assistance because they have transferrable job skills.
Those who are permanently laid off with little opportunity to return to
their previous occupation or industry often need assistance to find or
prepare for new jobs.
Under the Workforce Investment Act, Dislocated Worker services are
provided through the One-Stop system. Dislocated workers who require
assistance in finding new jobs can access a range of services at their
local One-Stop Career Centers, ranging from job search assistance to
assessment, counseling and retraining.
Question. In your opinion, will a $207 million reduction in the
Dislocated Worker program hurt the chances of those dislocated workers
finding new jobs?
Answer. The requested level for the Dislocated Worker program will
allow our State and local partners to meet the employment and training
needs of the affected workers. As a result of efficiencies in
administration and service delivery as well as carry-in funds from
prior years' appropriations, Dislocated Worker programs will have
levels of resources comparable to previous levels. States and local
areas whose needs exceed available resources may request assistance
through National Emergency Grants to provide additional Dislocated
Worker funding for workers affected by economic downturns.
one-stop coordination
Question. One of the cornerstones of the Workforce Investment Act
was the coordination of resources at the One-Stop, particularly those
provided under that Act and the Wagner-Peyser Act. Are the One-Stops
coordinating resources with the State Employment Service? Are those two
offices often located in the same building? If not, what are your
thoughts on how we could improve that coordination?
Answer. The clear intent of WIA is that State employment services
authorized by the Wagner-Peyser Act be delivered solely as part of the
locally designed One-Stop systems. In addition, Wagner-Peyser
employment and information services, including labor exchange services,
employment statistics and labor market information, are critical core
services that make One-Stop systems responsive to the universal
population. Wagner-Peyser re-employment services are also critical to
the linkage of unemployment insurance claimants to both employment
services and more specialized services available within One-Stop
centers/systems.
Nationwide, State employment services are entering into memoranda
of understanding regarding how services will be delivered in One-Stop
systems. WIA allows for different physical configurations within a One-
Stop system. Each local area must have at least one physical location,
a comprehensive One-Stop center, which provides core services and where
access to all ``required'' One-Stop partner services is available. In
addition, the law permits affiliated sites with specialized services as
long as the sites are part of the broader One-Stop system. The design
of One-Stop systems varies as it relates to Wagner-Peyser employment
services. There are three primary options for configuring how
employment services fit in a One-Stop system: (1) the employment
service office is the location of the comprehensive One-Stop center;
(2) employment service staff are fully integrated into the
comprehensive One-Stop center which is operated by another entity; or
(3) an employment service office is an affiliated office with staff
assigned to the comprehensive center.
It is the position of the Department of Labor that Wagner-Peyser
services must be integrated as closely as possible within a One-Stop
system. Therefore, we are working with our State partners to promote
integration in a number of ways including, but not limited to:
--developing policy guidance flowing from WIA and the regulations on
the role and ``fit'' of Wagner-Peyser employment services
within One-Stop systems;
--developing and providing technical assistance to State employment
service agencies, local boards, and One-Stop operators to help
facilitate the integration of Wagner-Peyser employment
services; and
--identifying best and promising practices and models for integration
to share among the States and local areas.
Question. The justification for flat-funding Job Corps assumes that
costs in the Job Corps program may have risen at the economy-wide rate
of inflation in the 2001 budget year, and that substantial funds will
be carried over into 2002. However, Job Corps centers are currently
experiencing inflation rates that are significantly higher than the
economy-wide rate of 2.1 percent. If, as a result of higher costs in
2001, the carryover anticipated for 2002 were not available, what would
be the impact on the quality of Job Corps operations?
Answer. Job Corps' ability to continue current services without an
inflationary increase is due primarily to savings from unplanned delays
in new center openings. These savings, combined with some cost
containment efforts, will adequately address our resource needs in PY
2003. Flat funding Job Corps in fiscal year 2002 will not impact the
quality of Job Corps operations.
Question. What would be the impact on the three new centers
scheduled to open in 2002? Would Job Corps have to close centers or
reduce the number of students served?
Answer. As indicated above, Job Corps' ability to continue current
services without an inflationary increase is due primarily to savings
from unplanned delays in new center openings. We will submit a report
to Congress detailing the status of those center openings and the
reasons for the current delays. Let us be clear that these center
opening delays are the result of a variety of unplanned events that are
in no way related to the fiscal year 2002 Budget level. Job Corps will
not close centers or reduce the number of students served.
additional youth program funding
Question. DOL proposes to revise the fiscal year 2001 appropriation
for the youth program by adding $45 million to it from funds
reprogrammed from other WIA programs. What is the rationale for adding
funds for 2001, then cutting funding in fiscal year 2002?
Answer. For fiscal year 2001, DOL proposes to reprogram the $25
million increase in 2001 from Youth Opportunity Grants and the initial
$20 million from the Safe Schools/Healthy Students initiative to move
funds from targeted programs to core job training programs, as
described in President Bush's Blueprint for New Beginnings. The
Workforce Investment Act was enacted to establish the core youth,
adult, and Dislocated Worker programs, and we believe our emphasis
should be on ensuring the success of these programs. The increase in
Youth Opportunity Grants in 2001 would have resulted in additional
sites that our fiscal year 2002 budget would not be able to sustain, as
would also be the case for the Safe Schools/Healthy Students
initiative. We are confident that, with the unexpended funds available
from previous years, our fiscal year 2002 request of $1 billion for
Youth Activities will be sufficient to serve the same number of young
people in need of WIA services as are projected to be served in 2001.
fiscal year 2002 funding level
Question. Does the fiscal year 2002 request reflect a one time
adjustment in funding as a result of lower than expected levels of
expenditures (due to the amount of time it is taking States to
implement WIA)? If so, does the Administration expect to request funds
in fiscal year 2003 to restore the cuts it is proposing in fiscal year
2002?
Answer. Yes, our fiscal year 2002 request does take into
consideration the fact that unexpended balances are roughly $600
million greater than the traditional level. Any fiscal year 2003
request will consider expenditure data between now and when PY 2003
funding levels are finalized, as well as the Administration's
assessment of the relative size of unspent balances carried into PY
2003.
state flexibility for training needs
Question. By decreasing funds, which effectively will decrease
carry over, is the Administration reducing the flexibility States have
to meet unexpected training needs that might occur if the economy
continues to weaken and more laid off workers need training to obtain
jobs?
Answer. As previously indicated, the Department and its State
partners will continue to address the needs of laid off workers through
awards of formula funds, supplemented, where necessary, by National
Emergency Grants.
funds reverting to the treasury
Question. Given the level of spending by States, would you expect
any fiscal year 2000 funds to revert to the Treasury if funding were
not reduced for the formula grant programs in fiscal year 2002?
Answer. States have the Program year of Federal award and the two
succeeding Program years to spend funds under WIA. Because of this, we
do not expect that these unspent funds will revert to the Treasury.
They will remain in the grant and carried over for use in future years.
unspent funds listed by state and by grant
Question. Could you please provide to this committee a list of the
amount of unspent grants expected for fiscal year 2000 and fiscal year
2001 for each State by formula grant program? If you have information
on projected unspent funds based on data more recent than December
2000, would you provide them to this committee?
Answer. The Department does not have projected end of year
carryover by State or program; the attached table shows aggregate
estimates by State for expenditures through December 2000 and is
submitted for the record. Our assumptions about expenditures for PY
2001 and PY 2002 are not State-by-State. Estimates may not be accurate
if applied to individual States given differences in State plans and
spending rates.
EMPLOYMENT AND TRAINING ADMINISTRATION STATE REPORTING OF FORMULA SPENDING WIA YOUTH ADULTS AND DISLOCATED WORKERS PROGRAMS COMBINED
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PY 2000 allotments Expenditures 7/1/00-12/31/00 (& PY Unexpended balance as of 1/1/01
--------------------------------------------------- 2000 Youth: 4/1/00-6/30/00) ---------------------------------------
Total Total available ---------------------------------------
Unexpended allotments 7/1/00-12/31/
State carry-in to PY PY 2000 portion (includes 00 (& PY 2000
2000 excluding FY 2001 advance advance funding Youth: 4/1/00- % of % of Total % of % of
advance funding funding available 6/30/00) Total allotments available allotments available
beginning FY
2001)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama..................... $7,204,025 $21,569,576 $18,435,358 $40,004,934 $47,208,959 $12,944,260 32.4 27.4 $34,264,699 85.7 72.6
Alaska...................... 453,000 6,220,665 6,804,719 13,025,384 13,478,384 2,734,243 21.0 20.3 10,744,141 82.5 79.7
Arizona..................... 6,170,133 22,265,696 18,050,796 40,316,492 46,486,625 10,087,539 25.0 21.7 36,399,086 90.3 78.3
Arkansas.................... 8,941,265 17,060,263 15,813,292 32,873,555 41,814,820 7,910,502 24.1 18.9 33,904,318 103.1 81.1
California.................. 50,370,517 310,532,858 319,358,288 629,891,146 680,261,663 136,440,050 21.7 20.1 543,821,613 86.3 79.9
Colorado.................... 3,804,877 11,133,399 10,794,033 21,927,432 25,732,309 5,900,041 26.9 22.9 19,832,268 90.4 77.1
Connecticut................. 3,620,292 12,391,413 11,276,123 23,667,536 27,287,828 7,063,815 29.8 25.9 20,224,013 85.5 74.1
Delaware.................... 1,694,396 3,603,138 2,887,440 6,490,578 8,184,974 4,167,507 64.2 50.9 4,017,467 61.9 49.1
District of Columbia........ 1,384,000 9,011,879 10,103,668 19,115,547 20,499,547 6,051,585 31.7 29.5 14,447,962 75.6 70.5
Florida \1\................. 65,279,463 62,533,829 56,846,081 119,379,910 184,659,373 86,121,969 72.1 46.6 98,537,404 82.5 53.4
Georgia..................... 11,966,905 32,680,141 29,305,954 61,986,095 73,953,000 13,874,807 22.4 18.8 60,078,193 96.9 81.2
Hawaii...................... 5,462,399 11,851,140 13,166,154 25,017,294 30,479,693 5,058,091 20.2 16.6 25,421,602 101.6 83.4
Idaho....................... 3,697,810 7,068,503 6,933,051 14,001,554 17,699,364 4,665,156 33.3 26.4 13,034,208 93.1 73.6
Illinois.................... 6,425,117 62,507,353 54,649,207 117,156,560 123,581,677 28,274,929 24.1 22.9 95,306,748 81.3 77.1
Indiana..................... 7,134,777 17,145,854 14,928,500 32,074,354 39,209,131 16,609,855 51.8 42.4 22,599,276 70.5 57.6
Iowa........................ 2,717,190 5,718,570 5,734,756 11,453,326 14,170,516 3,501,904 30.6 24.7 10,668,612 93.1 75.3
Kansas...................... 2,346,659 6,217,232 6,430,585 12,647,817 14,994,476 4,065,239 32.1 27.1 10,929,237 86.4 72.9
Kentucky.................... 34,811,212 23,190,724 19,259,988 42,450,712 77,261,924 18,029,020 42.5 23.3 59,232,904 139.5 76.7
Louisiana................... 12,202,135 34,855,558 31,745,279 66,600,837 78,802,972 13,427,930 20.2 17.0 65,375,042 98.2 83.0
Maine....................... 100,000 5,918,650 5,323,098 11,241,748 11,341,748 3,940,588 35.1 34.7 7,401,160 65.8 65.3
Maryland.................... 11,977,850 22,762,126 21,383,922 44,146,048 56,123,898 14,054,255 31.8 25.0 42,069,643 95.3 75.0
Massachusetts............... 3,070,000 20,596,131 18,433,727 39,029,858 42,099,858 15,477,068 39.7 36.8 26,622,790 68.2 63.2
Michigan.................... 10,625,065 43,150,489 35,227,909 78,378,398 89,003,463 25,246,367 32.2 28.4 63,757,096 81.3 71.6
Minnesota................... 4,862,114 12,661,947 11,192,310 23,854,257 28,716,371 11,136,597 46.7 38.8 17,579,774 73.7 61.2
Mississippi................. 7,545,109 19,849,458 17,445,585 37,295,043 44,840,152 8,407,897 22.5 18.8 36,432,255 97.7 81.2
Missouri.................... 9,220,801 22,537,168 20,531,057 43,068,225 52,289,026 11,812,901 27.4 22.6 40,476,125 94.0 77.4
Montana..................... 874,719 7,330,069 7,429,328 14,759,397 15,634,116 4,751,724 32.2 30.4 10,882,392 73.7 69.6
Nebraska.................... 1,562,920 3,843,427 3,370,955 7,214,382 8,777,302 1,593,856 22.1 18.2 7,183,446 99.6 81.8
Nevada...................... 1,023,781 6,236,289 6,052,345 12,288,634 13,312,415 3,126,560 25.4 23.5 10,185,855 82.9 76.5
New Hampshire............... 352,571 3,796,677 3,276,886 7,073,563 7,426,134 1,695,816 24.0 22.8 5,730,318 81.0 77.2
New Jersey.................. 18,918,820 39,764,126 38,034,164 77,798,290 96,717,110 27,749,286 35.7 28.7 68,967,824 88.6 71.3
New Mexico.................. 888,554 16,388,725 21,437,086 37,825,811 38,714,365 9,060,603 24.0 23.4 29,653,762 78.4 76.6
New York.................... 163,730,964 148,728,129 156,225,476 304,953,605 468,684,569 42,802,149 14.0 9.1 425,882,420 139.7 90.9
North Carolina.............. 13,648,284 23,561,472 21,935,374 45,496,846 59,145,130 15,529,729 34.1 26.3 43,615,401 95.9 73.7
North Dakota................ 735,455 3,522,617 2,725,413 6,248,030 6,983,485 2,234,580 35.8 32.0 4,748,905 76.0 68.0
Ohio........................ 18,566,094 61,982,728 50,847,933 112,830,661 131,396,755 15,795,680 14.0 12.0 115,601,075 102.5 88.0
Oklahoma.................... 3,965,403 15,582,047 13,092,549 28,674,596 32,639,999 5,553,484 19.4 17.0 27,086,515 94.5 83.0
Oregon...................... 7,288,406 28,275,038 30,992,014 59,267,052 66,555,458 14,705,981 24.8 22.1 51,849,477 87.5 77.9
Pennsylvania \1\............ 43,473,437 55,552,160 51,169,069 106,721,229 150,194,666 39,674,951 37.2 26.4 110,519,715 103.6 73.6
Puerto Rico................. 82,022,985 103,556,318 111,940,940 215,497,258 297,520,243 51,195,386 23.8 17.2 246,324,857 114.3 82.8
Rhode Island................ 732,708 4,082,645 3,811,684 7,894,329 8,627,037 2,536,074 32.1 29.4 6,090,963 77.2 70.6
South Carolina.............. 5,651,400 18,242,679 15,239,431 33,482,110 39,133,510 8,681,128 25.9 22.2 30,452,382 91.0 77.8
South Dakota................ 1,524,676 3,541,195 2,762,797 6,303,992 7,828,668 2,434,662 38.6 31.1 5,394,006 85.6 68.9
Tennessee................... 11,326,551 27,717,111 23,061,871 50,778,982 62,105,533 12,670,648 25.0 20.4 49,434,885 97.4 79.6
Texas....................... 67,300,071 134,094,193 111,733,955 245,828,148 313,128,219 119,541,113 48.6 38.2 193,587,106 78.7 61.8
Utah........................ 3,219,027 5,433,280 4,965,519 10,398,799 13,617,826 3,497,324 33.6 25.7 10,120,502 97.3 74.3
Vermont \1\................. 590,542 3,455,742 2,590,847 6,046,589 6,637,131 4,657,829 77.0 70.2 1,979,302 32.7 29.8
Virginia.................... 7,300,000 20,744,067 17,994,165 38,738,232 46,038,232 8,246,066 21.3 17.9 37,792,166 97.6 82.1
Washington.................. 12,731,724 35,864,208 34,182,597 70,046,805 82,778,529 20,479,984 29.2 24.7 62,298,545 88.9 75.3
West Virginia............... 10,000,000 20,886,759 23,332,050 44,218,809 54,218,809 13,094,672 29.6 24.2 41,124,137 93.0 75.8
Wisconsin................... 2,688,907 15,799,916 14,706,901 30,506,817 33,195,724 14,471,966 47.4 43.6 18,723,758 61.4 56.4
Wyoming..................... 2,688,907 3,688,545 3,059,298 6,747,843 9,436,750 2,819,580 41.8 29.9 6,617,170 98.1 70.1
-------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total Formula......... 765,894,017 1,636,703,922 1,558,031,527 3,194,735,449 3,960,629,466 925,604,946 29.0 23.4 3,035,024,520 95.0 76.6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Revised/corrected expenditures for Florida and Vermont; corrected carry-in for Pennsylvania.
Questions Submitted by Senator Tom Harkin
energy employees occupational illness compensation program (eeoicpa)
Question. In a televised interview (McLaughlin's ``One on One''
from 3/23/01) I understand you said the DOL has ``no capability, no
infrastructure'' to carry out the nuclear workers compensation program.
I am surprised at this statement given the history of Office of
Workers' Compensation Programs in administering the Federal Employees'
Compensation Act, as well as compensation for coal mine workers and
longshore and harbor workers. What capability and infrastructure do you
need to build?
Answer. My comments centered on the statutory deadline for the
Department to implement this large new program. This reality poses
significant challenges, thus warranting my public concern. While the
Energy Employees Occupational Illness Compensation Program bears some
resemblance to ESA's other compensation programs, its size, covered
population, and unique requirements have necessitated the establishment
of a new claims processing and adjudication infrastructure. The
Department has created a unit within ESA, with its own dedicated staff,
to handle the large number of expected claims. This unit will be
responsible for accepting and adjudicating claims under the program,
which will include such tasks as determining the probability that an
individual's cancer was as likely as not due to radiation exposures and
adjudicating all disputes arising from the claims process.
Question. Given your concerns, what are your plans to bring in
expertise to start the program?
Answer. Since EEOICPA's enactment, the Department has been working
with the Departments of Energy, Health and Human Services, and Justice
to implement this program in a fair and equitable manner. We have
utilized private-sector contractors to a great extent. In our efforts
to build the organizational structure to administer this program, we
are reaching out in a very broad way to recruit the staff necessary to
operate this program. This will include staff to adjudicate claims and
those with technical expertise in areas such as radiation measurements
and exposures. Simply put, we are utilizing every available resource to
assure the timely and effective implementation of this program.
Question. Would you consider setting up an outside advisory
committee to help address some of the issues? Could you use the
Department of Energy's Office of Environment, Safety and Health Public
Advisory Committee, which already has dealt with this program, for this
purpose?
Answer. As you know, the EEOICPA established an Advisory Board on
Radiation and Worker Health. In addition, as you note, the Department
of Energy's Office of Workers' Advocacy has also established an
advisory committee. We have been engaged with, and will continue to
participate in, the DOE Advisory Committee and will participate in the
Advisory Board on Radiation and Worker Health when it is established.
We will use these forums as well as continuing to meet with
stakeholders in a variety of other settings to get input on
administering this program. These avenues for obtaining input have
seemed most beneficial at this point, especially given the July 31
implementation deadline the Department must meet. In light of this
deadline, we have had to focus our efforts on ensuring that eligible
claimants receive benefits as soon as possible after this date. At a
later date, we will consider whether there is a need to establish
another advisory body.
Question. Last year the DOL proposed some amendments to the
EEOICPA, including adding an option of providing a sick worker with
lost wages. Do you support these proposed changes?
Answer. In January of this year, the previous Administration
forwarded a set of proposed amendments to the EEOICPA to Congress. The
extremely short deadlines for publishing regulations and implementing
this program have required DOL to focus exclusively since then on
efforts to promulgate regulations and create procedures and systems
necessary to undertake our responsibilities under EEOICPA and Executive
Order 13179. Thus, consideration of possible legislation must await our
completion of the initial implementation of the program. We will
consult with the Office of Management and Budget and other agencies
with responsibility under EEOICPA to assess the need for a legislative
proposal.
Question. I understand you recently recommended to OMB that ``the
Administration support technical legislation that will soon be
introduced to remedy some of the remaining deficiencies in the
EEOICPA.'' What are these deficiencies, what amendments to EEOICPA will
you recommend, and when you do expect the legislative proposal to be
introduced?
Answer. EEOICPA contains virtually no provisions concerning
administration of the program or review of decisions made on claims for
benefits. In drafting EEOICPA, Congress recognized that the statute did
not create a comprehensive compensation system when it directed
submission of further legislation to implement the program. In addition
to the almost total lack of administrative and review provisions, it
also contains ambiguous or unclear provisions and certain provisions
that appear to have adverse consequences that may not have been
intended. As noted in the previous response, however, extremely short
deadlines for implementing EEOICPA have required DOL to focus on that
task. We do intend, however, to further review this legislation and
consult with the Office of Management and Budget and other agencies
with responsibility under EEOICPA to determine the appropriate nature
and timing of a legislative proposal.
Question. I understand you said that DOL could not meet the
statutory deadline to begin accepting applications. When do you expect
to be ready to accept applications, and when should workers who qualify
expect to begin receiving compensation?
Answer. As a result of the extraordinary effort and dedication of
DOL's career staff, interim final regulations were published on May 25,
2001 and will take effect 60 days thereafter. This will allow us to
begin officially accepting applications on July 31, 2001, the date that
the legislation provides for the statute to take effect. For
straightforward cases, we expect to begin paying EEOICPA benefits by
early fall.
However, it must be recognized that there will be a surge of claims
filed in the first days of this program for illnesses and deaths
occurring over more than a half century. While we are making every
effort to address this up-front claims workload, it will be very
difficult to process this volume of cases immediately. Based on our
knowledge of this population, we expect that many claims will require
significant work on the part of DOL, DOE, and HHS to piece together
decades-old work history and exposure data. Claimants whose cases will
require complex adjudication--especially of those for whom HHS must
complete an individual radiation dose reconstruction--will need to
realize that it may take many months for all aspects of their case to
be fully reviewed.
Question. How do you expect to handle workers with covered
radiogenic cancers for whom dosimetry records do not exist? How will
they be considered for inclusion in a Special Exposure Cohort?
Answer. The Department of Health and Human Services' National
Institute on Occupational Safety and Health (NIOSH) has been assigned
responsibility for developing methodologies for ``reconstructing''
reasonable estimates of radiation doses received by individuals, and
for carrying out individual dose reconstructions in each case where the
claimant is determined by DOL to be a covered employee, but is not a
member of a Special Exposure Cohort. In the absence of complete
dosimetry data, these estimates will be used by DOL to determine the
probability that an individual's cancer was as likely as not due to
occupational radiation exposure. In addition, HHS is developing a
process for designating additional members to the Special Exposure
Cohort, with the advice of the Advisory Board on Radiation and Worker
Health. These issues will be addressed in the regulations being
developed for EEOICPA by HHS.
Question. How do you expect to coordinate with the Department of
Energy for workers whose illnesses may have been caused by radiation or
by hazardous substances?
Answer. The EEOICPA does not preclude filing for benefits under
both EEOICPA and State workers' compensation. EEOICPA provides for
assisting workers in obtaining State workers' compensation benefits
through the DOE Office of Worker Advocacy. We anticipate that
individuals who were exposed to both radiation and other toxic
substances will file claims under both programs. We are coordinating
with DOE in many areas, but particularly through the establishment of
joint DOE/DOL resource centers near nine major DOE nuclear sites, where
claimants will be able to get direct assistance in filing under either,
or both, programs.
Question. Does the budget include sufficient funds for timely
implementation of the program?
Answer. The funding for EEOICPA is sufficient and will not affect
our ability to meet the established time frames. The difficulties in
meeting the time frames are related to the tremendous amount of work to
be done, and the lack of lead time available to acquire and gear up the
staff and other resources necessary to be at peak capacity at the
inception of the program. Establishing the organization structure,
acquiring office space, purchasing equipment, hiring and training
staff, developing essential data, communications, and financial
systems, and developing detailed procedures for administering such a
complex program these are all major undertakings. I assure you that we
are doing everything possible to stay on schedule.
staffing shortages
Question. What is the Labor Department's strategy in addressing the
existing shortage of female-dominated jobs, such as nursing, day care
and teaching?
Answer. Within a few decades, some demographic experts believe the
American workforce simply will not be large enough to meet the demands
of a continually growing economy. Nurses, day care providers, and
teachers are a large part of this ``incredibly shrinking workforce.''
These professions are of tremendous value to our communities. Every
day they care for our neighbors and educate our children. The President
has begun the process of elevating the appreciation for the individuals
in these careers. We must show consideration for the value of these
professions not only in dollars and benefits, but also in respect.
The Department will continue to evaluate the Nation's current
skills gap and worker shortage and identify methods, including those
that cross Departmental lines, that allow us to address this problem--
both short- and long-term. We are, in fact, already working to address
some of these shortages. For example, under the Workforce Investment
Act of 1998, our locally-driven workforce investment boards may certify
occupations that are in demand in their area in which an eligible
individual may select training. For example, Certified Nursing
Assistants (CNAs) represent an occupation that is very much in demand
in most local areas. Therefore, an individual who goes to a One-Stop
Career Center and becomes eligible for training will likely see CNA
training offered as a response to one of the occupational choices. Many
One-Stop Career Centers also offer access to training in advanced
skills that require certification, such as medical laboratory
technicians, operating room technicians, and inhalation therapists.
bureau of international labor affairs (ilab)
Question. Madame Secretary, in this era of globalization, American
workers are now pitted against workers throughout the global economy in
tough, hard-nosed competition as never before. Their jobs and living
standards are at unprecedented risk. Why are you proposing such drastic
cuts in the Bureau of International Labor Affairs? This is the office
of the Federal Government that has the greatest expertise in
international worker rights issues (i.e. abusive child labor), and
labor standards at a time when President Bush is requesting trade
authority and even says there are legitimate trade-related worker
rights issues that must be addressed in the impending fast-track
debate.
Answer. The President's fiscal year 2002 request for ILAB preserves
the Bureau's core responsibilities and recognizes the importance of
eradicating all forms of abusive child labor and promoting
international labor standards throughout the world. Funding for these
programs has multiplied dramatically over the past years. The proposed
spending levels help us to effectively balance our priorities while
maintaining management controls and sensible spending policies that are
crucial to our domestic well-being.
The budget request includes funding for ILAB's core mission, and
provides $30,000,000 to support projects that remove children from
exploitative work and provide them with an education and their families
with viable economic alternatives; $10,000,000 to support work on an
HIV/AIDS through workplace-based prevention and education programs and
technical assistance to improve the working environment of employees
living with AIDS; and approximately $19,000,000 to continue
multilateral and bilateral projects to help developing countries
establish labor protections so that workers everywhere can enjoy
fundamental rights and principles at work and help strengthen the
ability of developing countries' to implement social safety net
policies and programs to foster economic growth.
Question. Madame Secretary, I am troubled by reports I've heard
that no appointment for the position of Deputy Undersecretary of Labor
for International Affairs is expected before this coming fall. Is this
true and, if so, how can you leave this important position vacant for
so long and still claim to be giving priority treatment to child labor,
enforcing worker rights law on the books, advancing trade-linked worker
rights issues and promoting greater respect for internationally-
recognized worker rights?
Answer. We plan to fill this position as soon as we have identified
a person with the qualifications and expertise we seek. In the
meantime, the Bureau is in the capable hands of experienced career
professionals.
pension and welfare benefits administration
Question. Last year, I worked with the Pension and Welfare Benefits
Administration to expand the assistance program through which they help
retirees understand their rights under the Employee Retirement Income
Security Act of 1974 (ERISA). I am disappointed to see that your budget
for this activity under the Policy, Regulation and Public Services
Account is cut by $1 million.
The retirement of the baby boom generation doesn't just affect
Social Security, it also creates a large influx of retirees that need
to understand their pension rights. In addition, the volatility of the
stock market rightly has all concerned, acutely affects retirees with
defined contribution and 401K plans. Given the increasing demand for
retiree assistance and the increasing importance of that assistance in
light of the changing economy, how do you justify cutting the one
Federal service that counsels retirees about their pension rights?
Answer. We have not reduced the request levels for benefit advisors
that counsel retirees and other participants about their pension
rights, nor have we reduced the levels of advisors that provide
assistance to employers in plan operations. The Pension and Welfare
Benefits Administration (PWBA) is committed to providing participant
assistance. There are currently 105 FTE dedicated to participant
assistance--16 in the national office and 89 in the field offices. In
fiscal year 2000, these Benefit Advisors assisted over 150,000
participants. Also in fiscal year 2000, PWBA adopted--for the first
time--a Strategic Plan for Outreach, Education and Assistance. The plan
includes specific performance measurements. PWBA also is beginning a
pilot project to implement an 800 number. Assisting participants in
health and retirement plans to make sure they understand their rights
and receive the benefits to which they are entitled is a priority for
me and the Department. PWBA will continue to fulfill this mission to
the fullest extent possible.
disparity in wia budget request reductions
Question. This budget requests a $473.9 million cut in employment
and training programs, claiming that unexpended carryover funds from
last year will allow States to maintain service levels while taking
that large of a cut. Madame Secretary, although large amounts of
carryover may exist in some States, the amount varies per State.
Dislocated Worker funds go to States on a formula basis. Therefore,
every State will take the same percentage cut in funding, regardless of
the amount of carryover they have.
First, how do you deal with the disparity between States with small
amounts of carryover and large cuts in fiscal year 2002 funds? Doesn't
this method of cuts actually punish States who have implemented the new
Workforce Investment Act quickly and efficiently?
Answer. Information received to date indicates very few States are
without significant carry-over available to maintain 2001 projected
service levels through 2002. The Department is prepared to assist these
States however possible. For example, the Department maintains a
sizable reserve for National Emergency Grants where Dislocated Worker
formula funds are insufficient to meet worker needs. As always, we will
move quickly to make these awards where the need is demonstrated.
Question. Second, these cuts will not go into effect until July of
2002 and your analysis of unexpended carryover is as of January 1,
2001. Do you not expect WIA to be fully implemented and working as
planned in the next 18 months?
Answer. The Department expects WIA to be fully implemented by June
30, 2001, and program spending to have resumed to levels commensurate
with amounts appropriated. As you indicate, the spending projections
are based on unspent balances as available December 31, 2000 and what
we believe to be reasonable estimates of increased spending through the
remainder of this program year. Based on these estimates and our
expectation that the WIA implementation issues that limited program
spending will be resolved and the program fully implemented, we have
projected an amount available on June 30, 2001 that, when added to
available PY 2001 funds and the amounts requested for PY 2002, will
allow spending, nationally, at levels greater that what was provided by
the Congress for 2001.
personal protective equipment
Question. Another important standard has been developed that
clarifies who pays for personal protective equipment that is required
by the employer. Some employers actually charge workers for ear plugs,
rubber boots and protective gloves, even though this is the primary
means of protection that the workers have, for example, from the
hazards of noise, slippery floors, and sharp knives. The OSH Act
requires the employer to pay for engineering controls, such as
ventilation and machine guards. When employers require workers to pay
for PPE, they are passing along the economic burden of controls to
workers, often those in the lowest paying jobs, such as poultry
processing. It is our hope that you would examine this issue, look at
the regulatory record, and urge final approval. This is not a major
regulation, and it is not a major issue to most employers. However, it
is a major cost to many low-wage workers who have to spend an
additional portion of their hard won paychecks in order to do their
jobs.
Can you tell me the status of the proposed regulation? Can you give
me a timetable on when it might be completed?
Answer. As discussed below, the new Administration has not
completed its review of OSHA's regulatory agenda. Until that review is
completed, I am unable to give you a timetable for this proposal.
lump sum pension distributions
Question. Please provide me with a detailed explanation of where
DOL and Treasury are regarding taking actions on the lump sum issue
discussed [in my request] and what the Pension and Welfare Benefits
Administration is doing to improve its ability to ferret out
significant broad failures of plans to properly inform plan
participants of their rights or to properly provide benefits.
Answer. I am familiar with the concerns raised in your January 2000
letter to Secretary of Labor Herman and Secretary of the Treasury
Summers concerning the information disclosed to pension plan
participants about their benefit distribution options. I believe that
pension plan participants need and deserve sufficient information about
their plan and benefits, including distribution options, to make
informed decisions about their retirement. We are reviewing this issue
and will respond more comprehensively when we have reached any
conclusions.
fair labor standards act (flsa)
Question. As you know, the Fair Labor Standards Act provides the
most basic labor standards for working Americans, including child
labor, minimum wage and overtime protections. In recent years,
enforcement of the Act has suffered from lack of funding for
investigators that are far too few in number to adequately enforce the
law in the many thousands of workplaces across the country.
Will you ensure that wage-hour enforcement gets the priority, and
the funding that it needs to protect the workers' wages?
Answer. I am committed to enforcement of worker protection laws.
One of my goals is to ensure an honest day's pay for an honest day's
work. While it is true that the number of investigators in the Wage and
Hour Division declined throughout the early 1990s, the number of
investigators steadily increased beginning in 1996 and is now at its
highest level. There is sufficient funding in the fiscal year 2002
budget to maintain the current level of investigators. In addition to
enforcement, compliance education is another strategy for protecting
workers' wages. I am encouraging the Department's enforcement agencies
to undertake a renewed emphasis on compliance assistance.
Question. While there have been slight increases, there are still
significantly fewer investigators than 15 years ago for more
workplaces. Will you press for and will you support funding for more
investigators?
Answer. At the end of fiscal year 2000, the number of investigators
in the Wage and Hour Division was equal to the number of investigators
in fiscal year 1985. Wage and Hour currently has 21 percent more
investigators than at the end of fiscal year 1996. While I appreciate
the fact that there are now more employers covered by the laws
administered by the Wage and Hour Division than there were 15 years
ago, I am not at this point seeking additional funding for
investigators. Rather, I believe that providing compliance assistance
to this increased number of employers is an important factor in the
equation to improve compliance with worker protection laws.
Question. In September 1999, the General Accounting Office issued a
report to the House of Representatives which found that many of the
nation's low-income workers were being illegally misclassified as
exempt from overtime, often by conferring on those workers fancy titles
that disguise the true nature of their work. For example, a cook paid a
salary of $200 per week may be called an Executive Chef and
misclassified as exempt from overtime.
Are you willing to use the resources of your office to stop this
kind of illegal exploitation of low-income workers by (a) increasing
enforcement, and (b) providing education to employers about their
responsibilities and providing information to workers about their
rights?
Answer. The primary goal of the Wage and Hour Division is to
increase compliance with labor standards laws and regulations,
including those affecting young workers, and workers in low-wage
industries. To increase compliance, Wage and Hour has adopted a multi-
prong strategy of compliance education, enforcement and partnerships.
Compliance education includes such activities as seminars for
employers and employer associations; town hall meetings for workers;
and distribution of a variety of compliance materials, including fact
sheets, compliance manuals and wallet-sized cards. In addition, the
Department has developed Elaws Advisors, an interactive internet-based
tool which provides easy-to-understand expert advice on the basic
requirements of the Fair Labor Standards Act and the Family and Medical
Leave Act. A separate module covers the Federal child labor
requirements. In September 2000, Wage and Hour began operation of the
first phase of the Technology for Excellent Customer Service program, a
national toll-free number to answer questions and refer callers to the
appropriate office for service.
The enforcement component of the strategy includes the use of
traditional enforcement tools like investigations; the assessment of
civil money penalties; targeted strike forces, particularly in low-wage
industries; and the use of the ``hot goods'' provision of the FLSA that
prohibits the shipment in interstate commerce of goods produced in
violation of the Act.
Establishing various partnerships leverages Wage and Hour's limited
resources and broadens the impact of the other strategies. Wage and
Hour enters into partnerships with employers and employer associations
to urge proactive steps to help ensure current and future compliance,
as well as with non-profit and community-based organizations, and
States and other Federal agencies to help reach low-wage employees and
make them aware of their rights.
Question. The GAO Report also found that the primary cause of this
type of exploitation was that regulatory minimum salary levels for
workers to qualify for overtime-exempt status had not kept pace with
inflation since they were last adjusted in 1975, a quarter of a century
ago. For example, in 1975 about 30 percent of the full-time work force
would have been automatically entitled to overtime because their pay
did not exceed these minimum salary levels. However, in 1998, because
of the failure of these levels to keep pace with inflation, only 1
percent of this workforce would be automatically entitled to overtime.
Will you support raising the minimum salary levels to account for
the effects of inflation over the last 25 years?
Answer. In May 2000 the House Subcommittee on Workforce Protections
of the Committee on Education and the Workforce, U.S. House of
Representatives, held a hearing in connection with the GAO's report and
received testimony from business and labor representatives, as well as
from the Department of Labor. Witnesses at the hearing confirmed GAO's
assessment that the ability to move forward with constructive and
appropriate changes to the regulations has proven extremely difficult
because of the strongly-held views of the many affected and interested
parties and the significant impact of possible changes. After that
hearing, the Department of Labor began a modest research effort to
identify areas in which we would need additional information to analyze
the evolution of the overtime-exempt categories of workers and how they
are classified by their employers. The regulations are currently
scheduled on the Department of Labor's regulatory agenda for upcoming
review and possible future revisions. However, there is much more to be
learned before we will be fully positioned to offer specific regulatory
changes.
osha ergonomists
Question. How many ergonomists does OSHA currently employ? Do you
have plans to hire more?
Answer. There is no Federal job classification titled
``ergonomist.'' However, OSHA currently has two certified professional
ergonomists; approximately six field compliance officers with advanced
degrees in disciplines in industrial engineering, with concentration in
ergonomics; between 20 and 30 field people who have extensive training
in ergonomic intervention in specific industries, such as meat packing
and textiles; and three individuals with extensive ergonomics expertise
with the Salt Lake City Health Response Team.
underreporting of injuries
Question. OSHA's research and the information collected at the
recent hearings show that there is extensive underreporting of MSDs. In
fact, based on the record compiled in the recent rulemaking process,
OSHA concluded ``that for every reported MSD, another MSD goes
unreported.''
What do you plan to do to correct this problem of underreporting?
Are you dedicating any additional resources to addressing this problem?
Answer. The Department is developing a comprehensive approach to
addressing ergonomics. One of the many issues we will investigate is
the underreporting of MSDs that OSHA asserted during the recent
rulemaking. While it is too early to say for certain, I believe that
lack of awareness of MSDs and an inability to universally define such
injuries are plausible reasons for underreporting. Furthermore, I
believe raising awareness of MSDs on the part of both employers and
employees will help to prevent MSDs before they occur. I intend to use
what I find from looking at the reasons for underreporting to create
systems that will disseminate information to employers and employees on
the best ways of preventing MSDs.
During the month of July, the Department will hold three forums to
address, among other issues, the definition of what constitutes an
ergonomics injury. The Department plans to publish a report, based on
the information collected from the forums, that will address the issue
of underreporting.
ergo ii
Question. You have repeatedly asserted that ergonomics is a
priority for this Administration's Department of Labor. Yet, the
Administration has indicated that it will nominate Mr. Eugene Scalia
for Solicitor General. As Solicitor General, Mr. Scalia would oversee
all standard setting or enforcement of ergonomics, yet Mr. Scalia has
repeatedly opposed any ergonomics standard, going so far as to call
ergonomics, ``a questionable science.'' In fact, Mr. Scalia has written
extensively in opposition to any ergonomics standard setting or
enforcement by OSHA.
Have you discussed with him the importance of ergonomics in this
Administration and is it your sense that he will actively pursue a new
ergonomics rule?
Answer. As Secretary, I have pledged to take a comprehensive
approach toward ergonomics. I have met with numerous stakeholders and
experts to discuss the issue during my short tenure, including
representatives of workers, industry, and safety and health
professional, and I have outlined certain key principles that will
guide the Department's approach toward ergonomics under my leadership.
Eugene Scalia, the President's nominee for Solicitor of Labor, has a
broad range of experience in labor and employment law and a
distinguished record of service in past administrations. I have
emphasized to him the importance of the issue of ergonomics to this
Administration and to the Congress. I am confident that, as Solicitor,
he will faithfully discharge his responsibility to legally represent
whatever ergonomics policy we establish.
osha enforcement budget
Question. There is a $3 million increase for OSHA's enforcement
budget, there is also a cut of 64 FTEs. The budget indicates that OSHA
will conduct 36,400 Federal enforcement inspections in fiscal year
2002, the same as fiscal year 2001. How will the agency conduct the
same number of inspections with fewer enforcement officers?
Answer. None of the FTE being cut are compliance safety and health
officers. As a result, the agency will be able to conduct the same
level of inspections as in fiscal year 2001. The staffing cuts reflect
reductions in management and FTE associated with reinvention, not front
line inspector positions.
osha standards
Question. You have laid out a very ambitious health and safety
standard setting program and I commend you for that. OSHA expects to
issue 15 proposed standards in fiscal year 2002, versus only one in
fiscal year 2001, and 6 final standards in fiscal year 2002, versus 5
in fiscal year 2001. Can you give me the status of the following
standards and whether you will publish them in final form in fiscal
year 2002?
--Tuberculosis
--Employer payment for personal protective equipment
--Glycol ethers
--Signs, signals and barricades
--Exit routes update
--Personal fall protection systems
Answer. The new Administration is still reviewing the regulatory
agendas of the Federal agencies, including OSHA. Until that review is
complete, it would be premature to specify OSHA's regulatory priorities
or timetables for specific projects.
wia budget request reductions
Question. We are currently in the midst of the first year of
implementation of the Workforce Investment Act, and people throughout
the country are working hard to change our systems to accommodate the
new Act. Many areas have had slow rates of expenditures over the first
6 months of the program, but as they get their systems up and running,
the expenditure rates are increasing every day.
However, the effect of these proposed cuts will not be felt until
July 2002, when all systems should be running smoothly.
I am concerned about making cuts which are based on projections
made only 6 months into the new Act. Can you discuss the implementation
of the Act and reassure me that these cuts will not result in cuts in
service?
Answer. The transition from the Job Training Partnership Act
structure to the new Workforce Investment Act has resulted in much
slower spending than originally projected. While many jurisdictions
jump started partnership- and system-building activities during PY
1999, July 1, 2000 marked States' and local communities' transition to
WIA and its many reforms. Because of the nature of these reforms, full
implementation of WIA by States and local communities is taking longer
than originally expected, and the current lower than expected
expenditures reflect this one-time phenomenon. While fewer participants
will be served in PY 2000 than were served in PY 1999, States and local
communities will be able to serve many more participants in PY 2001 and
PY 2002 because of the availability of the carry over funds.
Major reasons for slower than anticipated activity include:
Implementing Fundamental WIA Changes Takes Time.--WIA requires
fundamental system-wide changes in service delivery, the make-up of
eligible service providers, and new customer service requirements. In
addition, there also were major changes to State and local governance
structures.
Workforce Investment System Access to Other Funds.--State and Local
Workforce Investment Boards are encouraged to think strategically about
how to use WIA and other funds most effectively in order to address
labor market needs of the broad population served by WIA. They have
used other funds available such as JTPA carry in dollars or Pell grants
for low-income, college-ready adults before drawing down PY 2000 WIA
funds.
More Emphasis on Universal Labor Exchange.--States and local
communities have spent much energy and time on making the One-Stop
Center networks under WIA work so that customers can access information
about core job training, education, and employment services at a single
location.
______
Questions Submitted by Senator Ted Stevens
Question. I am concerned that the Labor Department budget proposes
a workers' compensation surcharge that would cost the Defense
Department an additional $36.7 million--and all Federal agencies a
total of $80.3 million. What is the rationale for including this
legislative proposal in an appropriations bill? If Congress denied this
request, where would you suggest making cuts elsewhere in your budget
to restore the funds needed to administer workers' compensation
programs?
Answer. Ensuring the safety of American workers is a priority of
the Department of Labor. In the Federal arena, we see an urgent need to
focus the actions of the employing agencies on increasing worker
safety, in part, by highlighting for them the full cost of worker
injuries, including the cost of administering the Federal Employees'
Compensation Act (FECA) program. As you know, Federal agencies are
billed each year for cash and medical benefits that have been paid to
their employees under FECA, while DOL bears the cost of administering
the program. The fiscal year 2002 Budget proposes to integrate benefit
and administrative costs by allowing DOL to add an administrative
surcharge to the annual bill DOL now sends to Federal agencies for FECA
benefits. Because the surcharge is based on an agency's FECA benefits,
we believe this proposal would provide an additional incentive for
agencies to control FECA costs by preventing injuries and cooperating
in return-to-work efforts.
We believe that an appropriations bill is the most efficient
vehicle for establishing an appropriate funding mechanism that both
ensures adequate funding for the administration of the FECA and
enhances the safety of Federal workers by demonstrating the real cost
of injuries. Our budget proposal provides for a surcharge that
accomplishes this purpose and establishes guidelines and limitations
for its use. Further, as the cost of Federal workers' compensation is a
budget issue for the Federal agencies, we believe an appropriations
bill is the best vehicle for addressing the issue.
Clearly DOL cannot administer FECA absent Federal resources. If
Congress decides not to enact this proposal, the Administration will
work with Congress to identify alternative resources for the
administrative costs of the FECA program.
mass layoffs
Question. Mass layoffs are increasing. In January alone, employers
announced 1,522 mass layoffs, involving the projected loss of more than
200,000 jobs. In the last year, 647,000 workers who lost their jobs due
to mass layoffs filed for unemployment compensation. Wouldn't it be
better to increase funding for Dislocated Worker training, instead of
paying out longer unemployment benefits?
Answer. Under the Workforce Investment Act, dislocated workers
receive services designed to meet their individual needs for assistance
to help them return to work as quickly as possible. Individualized
assessment of worker needs in One-Stop Career Centers helps to
distinguish those dislocated workers who might return to work with
minimal reemployment assistance from those who require more extensive
help. Workers in the latter category include those with obsolete
skills, with limited English proficiency, and workers in some
communities that lack a diverse economic base.
Services for dislocated workers include a full range of activities,
beginning with computerized job matching and resume posting, and
extending to in-depth assessment and occupational skill training.
Although many workers' training costs can be supported through Pell
Grants and other resources, adequate funding for Dislocated Worker
training is critical to meeting basic program goals. Our fiscal year
2002 budget request, combined with State unspent funds, will ensure
that services to dislocated workers will not decrease from PY 2001.
For Dislocated Worker programs to achieve their goals of timely
reemployment at good wages, the choice is not necessarily between
longer unemployment benefits and increased funding for Dislocated
Worker programs. Because workers who need additional skills to achieve
quality reemployment must devote time to acquiring those skills in lieu
of working, training for dislocated workers cannot stand alone. It must
be supplemented by Unemployment Insurance (UI) benefits which provide
needed partial wage replacement so that individuals can meet current
living expenses while receiving training. The UI benefit helps reduce
the financial hardship caused by loss of employment for individuals
while at the same time helping to automatically stabilize the economy.
For those workers who continue in training after their UI benefits are
exhausted, needs-related payments are an available resource.
______
Questions Submitted by Senator Patty Murray
Question. Secretary Chao, what is the Administration prepared to do
for aluminum workers and other workers in the Pacific Northwest who
lose their jobs due to the energy crisis?
Will your budget request provide sufficient resources to help
workers who find themselves suddenly unemployed given the
Administration's expressed concerns about a potential recession?
Answer. The Department's discretionary National Emergency Grant
(NEG) program is designed to provide reemployment services, supportive
services and retraining activities in response to mass layoffs and
plant closures affecting large numbers of aluminum workers and other
industries. Additionally, all communities have funds available to them
through formula grants to serve dislocated workers. For example, in PY
2000 the State of Washington received $28.2 million in formula funds to
assist communities in the State in serving dislocated workers, a 103
percent increase over the previous year's funding under the Job
Training Partnership Act. Oregon received $30.4 million, a 72 percent
increase.
exposure of miners to asbestos in libby, montana
Question. Are you familiar with the Inspector General's recent
report on MSHA's handling of inspections of the mine in Libby, and with
the recommendations contained in the report? Do I have your commitment
that the Department will make it a top priority to implement the
recommendations that require rulemaking as quickly as possible?
Answer. Yes, I am familiar with the Office of the Inspector
General's (OIG's) report of March 22, 2001, Evaluation of MSHA's
Handling of Inspections at the W.R.Grace & Company Mine in Libby,
Montana. We are extremely pleased that the Senate has confirmed Mr.
David Lauriski as the new Assistant Secretary of Labor for Mine Safety
and Health. Both he and I are committed to protecting miners' safety
and health, including preventing their exposure to harmful contaminants
such as asbestos.
I have asked Mr. Lauriski to review the facts and the OIG's
recommendations and consult with the affected parties to develop a
course of action.
energy employees occupational illness compensation program act
(eeoicpa)
Question. Secretary, I believe you have said (McLaughlin's ``One on
One'' taped on March 23, 2001) the Labor Department has ``no
capability, no infrastructure'' to carry out the nuclear workers
compensation program.
What are your plans to develop the infrastructure so you can get
this program running?
Answer. My comments centered on the statutory deadline for the
Department to implement this large new program. This reality poses
significant challenges, thus warranting my public concern. We have been
working diligently to develop the necessary regulations, organization,
systems, and procedures for carrying out the Energy Employees
Occupational Illness Compensation Program Act (EEOICPA) in as timely a
manner as possible. In doing this, we have been utilizing our
experiences in administering the workers' compensation systems for
Federal employees, longshore and harbor workers, and miners suffering
from black lung. As I have explained in response to questions from
other members of the Subcommittee, while the EEOICPA has some features
similar to parts of each of the programs mentioned, its provisions are
sufficiently different from any of those programs that is necessary for
us to develop a separate infrastructure. Furthermore, the substantial
number of claims that we expect to be filed in the first few years also
requires a separate organizational unit, with dedicated staffing. This
unit will be responsible for accepting and adjudicating claims under
the program, a responsibility which will include determining the
probability that an individual's cancer was as likely as not due to
radiation exposures and adjudicating disputes. We have been working
with the Departments of Energy, Health and Human Services, and Justice
to implement this program in a fair and equitable manner. We will be
utilizing private sector contractors as well as reaching out in a very
broad way to recruit the necessary staff to adjudicate claims and
supply the necessary technical expertise in areas such as radiation
measurements and exposures.
Question. On March 9, you wrote to Mitchell Daniels, Director of
OMB, that you recommended that ``the administration support technical
legislation that will soon be introduced to remedy some of the
remaining deficiencies in the EEOICPA.'' What are these deficiencies
and how do you see them remedied? What is the status of this
legislative proposal?
Answer. As enacted, the EEOICPA contains few provisions concerning
administration of the program or review of decisions made on claims for
benefits. In addition, the Act also contains ambiguous or unclear
provisions, some of which may have unintended consequences. The
extremely short deadlines for implementing this program have required
DOL to focus exclusively on efforts to promulgate regulations and
create procedures and systems necessary to undertake our
responsibilities under EEOICPA and Executive Order 13179. Thus,
consideration of possible legislation must await our completion of the
steps needed for the initial implementation of the program. We do
intend, however, to further review this legislation and consult with
the Office of Management and Budget and other agencies with
responsibility under EEOICPA to determine whether and what type of
legislative proposal is warranted.
women's bureau equal pay
Question. The previous administration make bridging the wage gap a
priority. What specific steps will the Bush Administration take to
solve this serious problem?
Answer. In 1963 the Equal Pay Act was passed, and since then women
have continued to make tremendous advancements in the labor force.
Today, women earn more than half of all college degrees, and nearly
half of all graduate degrees. With this increased education comes
increased earning power for women, and the pay gap has narrowed
significantly over time.
The Department of Labor, through the Women's Bureau, will continue
to pursue a vigorous program of outreach to increase women's awareness
of new opportunities for education, training, and employment. In
addition, we will continue to inform employers of their
responsibilities under the Equal Pay Act and to fight gender
discrimination.
youth programs
Question. The 21st Century is rapidly approaching and the skills
that will be most valuable in our country are ever changing. The
workforce must, therefore, have the ability to adjust to the times.
Currently, too many Americans are left behind in this sweeping change.
The days when one could easily earn a living wage with a high school
education are rapidly diminishing. Today, workers need more education
and training to develop skills that reflect our changing economy. I am
concerned that your budget provides $222 million less for youth
employment and training programs. We should be increasing not
decreasing our investments that focus on one of our most vulnerable
sectors of the workforce, young people.
Fewer resources for programs like the Youth Opportunity Grants
program will ensure less children are making productive transitions
from school to work.
I must point out that your proposed funding request for the
Rewarding Youth Achievement Program is on the right track by focusing
on children in high poverty areas and providing them with employment
opportunities they wouldn't normally receive. It is very important that
the Department of Labor is a valued partner in providing young people
opportunities to receive needed job skills to be competitive in the
modern workforce.
Secretary Chao, what specific measures will you take to ensure
these youth are provided with opportunities to learn needed job skills?
Answer. Although the fiscal year 2002 budget request provides $222
million less for youth employment and training programs, this request
does not diminish our investment in one of the country's most valuable
resources, America's youth. In fact, the request for WIA youth
activities allows the Department to serve the same level of youth as
will be served in 2001--721,000 youth. The transition from the Job
Training Partnership Act has resulted in significant underspending as
State and local programs gear up to fully implement the numerous
structural changes in the workforce investment system under WIA. As
these unspent funds are carried forward and States become fully
operational, service levels will increase creating more opportunities
for America's young people. The Department will work vigorously with
State and local communities to ensure that systems are in place to
provide opportunities for young people to learn the needed job skills
and receive the necessary support to achieve academic success.
shortage of caregivers
Question. This past week, HHS Secretary Thompson testified before
this Subcommittee on the need to address the current shortage of
caregivers nationwide, particularly in our Nation's nursing homes and
assisted living facilities where there's a shortage of 250,000 CNAs and
60,000 RNs. This Subcommittee would like to work closely with you in
the effort to address this serious problem to ensure that the nation's
frail elderly receive quality care.
I am interested in your thoughts on ways to address this shortage
of caregivers?
Answer. The Department of Labor is cognizant of the need for more
caregivers at all skill levels and is working to address this issue.
For example, under the Workforce Investment Act of 1998, an eligible
individual may select training in high-demand occupations certified by
their local workforce investment board. Certified Nursing Assistants
(CNAs) represent an occupation that is very much in demand in most
local areas. Therefore, an individual who goes to a One-Stop Career
Center and becomes eligible for training will likely see CNA training
offered as a response to one of the occupational choices. Many One-Stop
Career Centers also offer access to training in advanced skills that
require certification, such as medical laboratory technicians,
operating room technicians, and inhalation therapists.
In addition, a substantial number of the 190 Welfare-to-Work
competitive grantees (representing an investment of nearly $700 million
dollars over six years) offer welfare recipients and other low-income
individuals training and work experience opportunities to gain
employment as a CNA or in other health occupations.
Finally, the H-1B Technical Skills grant program provides
specialized, high skill training to American workers desiring to
upgrade their skills to fill occupations that are now filled
temporarily by foreign workers. In 2001, we expect to have
approximately $180 million available for the H-1B Technical Skills
grants. Through this program, the Department has recognized health care
occupations, particularly registered nursing, as a specialty
occupational area in high demand.
Some H-1B Technical Skills grants have focused specifically on
health care training, in particular nursing training. In New York, the
League/Service Employees International Union (SEIU) 1199 Training and
Upgrading Fund received an award that proposed to train 675 employed
and unemployed health care workers for high demand nursing positions.
Under another grant, the State of Vermont and the Vermont Human
Resources Investment Council will work together to provide a mix of on-
the-job training and on-site instruction for critical care nurses to
place workers in 16 hospitals. Workforce Essentials, an H-1B Technical
Skills grantee in Clarksville, Tennessee is training registered nurses.
legislation for long-term care givers
Question. In the Senate, work is now underway on legislation that
would provide $500 million a year for the next three years, in grants
to States, to promote the nursing profession and to help long term care
providers recruit, train, and retrain caregivers at all levels. Would
you be supportive of this approach to addressing the caregiving
shortage?
Answer. The Department of Labor is very interested in efforts to
address employers' demand for skilled workers while also providing
opportunities for unemployed and underemployed individuals to increase
their skills and advance in their careers. The Administration is
particularly concerned about communities that lack access to care and
plans to reform the National Health Service Corps to better define
shortage areas and target placements of non-physician providers
practicing in communities.
The Administration will carefully review and consider legislation
to address this issue. Once the legislation has been reviewed, we will
be happy to share our views with you.
immigration of health care professionals
Question. HHS Secretary Thompson testified before this committee
last week that part of the solution might be tied to allowing more
foreign nurses and health care workers to immigrate to the United
States to help fill the void. Would the Labor Department be willing to
work directly with HHS, the Department of Justice, and the Immigration
and Naturalization Service to create an immigration program that can
help meet this need?
Answer. The Department currently is administering the H-1C
nonimmigrant nurses program, which is intended to address nursing
shortages in areas where there are spot shortages. It previously
administered the now-expired H-1A nonimmigrant nurses program. The
Department of Labor would be, of course, willing to work directly with
HHS, the Department of Justice, and the Immigration and Naturalization
Service to develop creative ways to address this problem over the long-
term.
______
Question Submitted by Senator Thad Cochran
migrant and seasonal farmworker housing program
Question. In the past, this subcommittee has included
appropriations report language directing the continuation of a small,
but important program that assists farmworkers in gaining better
housing. Since at least 1983, I have worked with the Department to
ensure a network of local organizations, including one in my State,
receives funding to plan, develop, and manage housing for migrant and
seasonal farmworkers. There is a well established network of local
housing organizations that receive these funds.
In the fiscal year 2001 Labor Appropriations report, language was
included to provide $4 million in funding for this network. This amount
was an increase of $1 million over the fiscal year 2000 level. I am
hopeful that the Department of Labor will continue to support increased
funding for this important program.
I look forward to working with you and the Department in the
future. Thank you.
Answer. The Department of Labor will provide a total of $4 million
for competitive and non-competitive farmworker housing grant activities
in Program Year (PY) 2001. Grants totaling $3.6 million will be awarded
competitively to fund housing and housing development activities for
migrant and seasonal farmworkers. The Department is also funding on a
non-competitive basis the Hope Migrant Rest Center for $333,000. The
Center provides overnight and temporary lodging to over 40,000 migrant
farmworkers and their families who criss-cross the country in search of
and en route to seasonal agricultural jobs.
Grants to the National Farmworkers Jobs Program authorized under
WIA section 167 will total $72 million for PY 2001. These programs also
provide for direct assistance to eligible farmworkers for transitional,
temporary, or emergency housing in support of job training activities,
or agricultural employment.
Senator Specter. Okay. Thank you all very much.
Secretary Chao. Thank you.
SUBCOMMITTEE RECESS
Senator Specter. The subcommittee will stand in recess to
reconvene at 9:30 a.m., Thursday, May 10, in room SD-192. At
that time we will hear testimony from Dr. Roderick Paige,
Secretary, Department of Education.
[Whereupon, at 10:47 a.m., Wednesday, May 2, the
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
May 10.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002
----------
THURSDAY, MAY 10, 2001
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:37 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Harkin, Reid, and Murray.
DEPARTMENT OF EDUCATION
Office of the Secretary
STATEMENT OF DR. RODERICK R. PAIGE, SECRETARY OF
EDUCATION
ACCOMPANIED BY THOMAS P. SKELLY, DIRECTOR, BUDGET SERVICE
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen of the
subcommittee on Labor, Health, Human Services and Education.
The Appropriations Committee will now proceed.
This is the first hearing where we have an opportunity to
welcome the distinguished Secretary of Education, Dr. Paige. He
brings to this Cabinet position a very distinguished record; a
bachelor of science from Jackson State University; a master and
Ph.D. degrees from the University of Indiana. He had been the
superintendent of the Houston Independent School District, a
job of enormous responsibility, where he was innovative and
very accomplished. He previously served as Dean of Education
and Athletic Director at Texas Southern University.
In addition to the widespread praise and reputation, he has
been awarded the 1999 Richard R. Green Award by the Council of
Great City Schools, the 2000 Harold W. McGraw, Jr. Prize in
Education from the McGraw-Hill Companies, and the 2001 National
Superintendent of the Year Award from the American Association
of School Administrators.
Education Budget Issues
Dr. Paige, you come to present the administration's budget
request on a day when, as you know, the Senate is considering
the Education bill.
Secretary Paige. Right.
Senator Specter. A very complicated matter. We have set it
aside, briefly, to take up the budget. There are nine pending
amendments. To say it is a quagmire would be an understatement.
But I have seen, in the time I have been here, that
institutionally the Senators are a lot smarter than any of the
individual Senators. I would not say that for secretaries, but
for Senators and--and the Senate has a way of working through
the problems.
There are a great many subjects that we want to ask you
about today; the allocations, some of the additional programs,
some of the programs which have been cut, the problem of campus
crime, the Youth Violence Initiative which this subcommittee
put into operation, the issues on class size, more teachers,
and the school construction.
And I turn now for an opening statement from my
distinguished colleague, Senator Harkin.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Thank you very much, Mr. Chairman. And I
cannot think of a more timely time to have this hearing than
right now, when we are involved in a debate on the Senate floor
on the Elementary and Secondary Education Act reauthorization.
We welcome you, Mr. Secretary, for this very important
budget hearing. We can talk all we want to about education and
how we all love it and how we want to make education better,
but if the resources are not there, it is just more of the same
old rhetoric.
Now, Mr. Secretary, I have a great deal of admiration for
you and for your background and what you have done for
education. So, I hope that what I am about to say you do not
take personally----
Secretary Paige. I will not take it personally.
Senator Harkin [continuing]. But take it policy-wise.
Secretary Paige. Yes. Thank you.
Senator Harkin. And I had great hopes earlier this year
when President Bush was talking about leaving no child behind.
When he picked you to be his Secretary of Education, I thought
we are going to be on our way. And quite frankly, my hopes, I
think, have been dashed. The budget this year is just
incredibly inadequate, in terms of education.
Special Education Funding
Now, I am going to just start, first of all, by reading an
article that was in the paper this morning. Now, I do not know
if it is true or not, but I am going to read it to you.
It said--it is talking about the education plan. It said,
``The administration indicated it was particularly upset--
particularly upset--by a vote last week to increase funding for
schooling disabled students and to lock it into the Federal
budget for the next 10 years by shielding it from the annual
appropriations process. Officials described the proposal as
`costly and unwarranted.'''
I hope that official was not you, Mr. Secretary.
Well, after all these years, on both sides of the aisle,
talking about getting the Federal Government up to its 40
percent of the average per pupil expenditure for kids with
disabilities--and you and I have talked about this personally
in my office--the Senate finally, on a unanimous vote--
unanimous, which means when we offered the amendment, we did
not even ask for a vote; it was unanimous, because no one
objected--unanimously said, ``We are going to appropriate, not
just authorize, but we are going to appropriate about $181
billion over 10 years to meet this need.''
And now, the administration says they are upset about it;
that it is costly and unwarranted. I beg to differ.
Tax Cut package and Education funding
Second--or third, I guess, Mr. Secretary, the Senate
adopted an amendment that both of us supported, that would have
shifted $250 billion out of the $1.6 trillion tax cut, and put
it into education. Well, the House had passed the
administration's $21.3 billion for 10 years.
Well, you would think, when it went to conference, they
might have compromised someplace in the middle. The budget we
got back is zero. The budget that we have, that we are going to
vote on today on the Senate floor, has zero increase above
baseline for education for the next 10 years. They did not even
put in the President's $21.3 billion, let alone the $250
billion that we had supported in the Senate.
And so, I would like to have your thoughts on that and find
out, well, why is not the administration saying something?
School Renovation Funding
I am disappointed that they have eliminated the $1.2
billion fund for school modernizations.
The American Society for Civil Engineers recently issued a
report--they gave our schools a D-minus. The lowest grade of
all of the facility infrastructure in America was our schools.
Finally, the Senate and the House, last year, began the
process of reaching out to help modernize our schools, and the
administration has zeroed that out.
Well, I know that money alone will not improve schools. I
have heard that all the time, but tell me how you are going to
repair a roof, if you do not have some money; how you are going
to build an extra classroom, if you do not have some money.
Sure, we want accountability, testing--I can work my way
through all of those, but if we do not have the resources in
there to build decent schools for kids, I am sorry, I am out of
here. And I just do not understand where the administration is
on this.
Strategic Review of Education Budget
Well, lastly, I just say this: Next week Defense Secretary
Donald Rumsfeld will announce the results of a strategic review
of the Defense budget. And then, the President plans to submit
a new budget request based on those results. And the rumors I
am hearing around here were on Defense appropriations, we are
going to commit an additional $20 billion to $30 billion per
year.
Why can we not do that for schools? Why would not the
President have a strategic review of the education budget, and
ask the question, are all our kids ready to learn when they
enter school?
In 1989, President Bush, the Governors, we all decided on
Goals 2000. We are going to meet Goals 2000 in education. First
goal, every child ready and able to learn by the time they
enter school. 2000 was last year, and we are not even anywhere
near it.
Are our classes small enough to promote learning? Are our
schools in good repair? Are teachers well trained?
Well, if the answers are no, why do we not have a strategic
review and come back with a budget that will meet these needs?
But no, what I read is they cannot even support what we finally
decided on a bipartisan basis to do. And that was to meet the
needs of special education.
So, Mr. Secretary, I have great respect for you.
Secretary Paige. Thank you.
Senator Harkin. And I mean that, personally. Your
background speaks well. But I am telling you, this budget is
awful, when it comes to education. And I just hope that you
will speak up and fight as hard as you can, as a Secretary, to
say that this is unacceptable to everyone.
I am sorry to be so emotional about it, but my gosh, we
have got to do something about this education budget.
Thank you, Mr. Chairman. I am sorry.
Senator Specter. Well, so much for the level playing field,
Mr. Secretary.
Well, Senator Harkin never minces words. We know exactly
where he stands.
In the end, we have had a record for coming together in a
collegial way. And I am optimistic we will do the same thing
here.
Education 302(b) Congressional Budget Allocation
I might just add one more word before you begin your
testimony. We are trying to get an allocation for this
subcommittee which will accommodate the points that all sides
are making, the points the President is making, the points the
Secretary is making, what Senator Harkin has in mind, what his
caucus has in mind.
Without giving you the bitter experience of last year, this
subcommittee set a mark at $106 billion, which was President
Clinton's figure, which was candidly more than my caucus wanted
to set, but with a lot of effort, that was established. And we
re-allocated some of the priorities. And then we had a dispute,
and at one point it looked like we were going to $114 billion
instead of $106 billion. And we finally ended up at a little
over $107 billion.
And this year I am concerned that when we go to the floor,
there will be add-on amendments. And 13 republicans, last year,
voted with the democrats to add the funds. And as the manager
of the bill, I stuck with the figure and cast more bad votes in
3 days than I passed in the past 19 years on my own preferences
for allocations.
So, if we get an allocation which can accommodate at the
start, I think we will make some headway. Some in my caucus
say, ``Well, the President will veto a bill which is too
high.'' Okay. But then it comes back to the Congress. And what
do you do from there? With a 50-50 split, my very strong
conviction is we ought to come to terms at the outset on a
total figure, and then work on the priorities as to how we meet
it, as opposed to taking one amendment after another, which
will ultimately run the severe risk of leading to gridlock.
With that overly long introduction, Mr. Secretary, we look
forward to your testimony.
Summary Statement of Dr. Roderick R. Paige
Secretary Paige. Mr. Chairman, thank you so much. And I
actually benefitted from those comments. And I appreciate them.
I even appreciate the comments of Senator Harkin. I especially
appreciate his passion because I know he means that very
deeply. We have some points of disagreement on emphasis, but I
assure you that I really respect your interests in the children
of America, as I do the other members of this fine committee.
Thank you for the opportunity to testify on behalf of
President Bush's 2002 budget for the Department of Education.
As you know, the President has made education his highest
priority, and has reflected that in his budget request.
Excellence in Education must be Nationwide
The reason for this is simple. There is no part of our
interest more important to the future of our Nation than the
education of our children. And fortunately, in pockets and
corners around the country, dedicated teachers in our
exceptional schools are safeguarding our future by fixing and
giving children rich and exciting experiences in learning. And
we congratulate them, because we know of their dedication and
commitment. And the children who attend those schools are not
being left behind.
Those schools do not represent the norm. Basically, our
system is going to be required to be fixed in order to achieve
the goal of educating all of our children. And no society has
ever attempted that before.
Most societies have even gone so far as to assign or
designate those children who should be educated and those who
should not. To say that no child should be left behind is a
pretty aggressive goal. That requires the system to work. So
pockets of excellence will not work here.
And even as we congratulate those schools that are great
and those teachers and principals and parents and PTA members
who are causing that greatness, we congratulate them, we say it
is insufficient and we need to fix the system.
Excellence Requires Change
And so, the emphasis in the President's budget is about
reform, about changing things. We do not think continuing on in
the way we are going will accomplish this. If things do not
change, they stay the same. And we know that the same is not
satisfactory.
NAEP Testing Results--4th Grade Reading Scores
Last month I had the dubious distinction of participating
in the announcement of the latest results from the National
Assessment of Educational Progress in reading for our 4th grade
students. And any caring person who heard those results will
agree that we cannot keep doing the same. I call it dubious,
because the only news that I had to comment on after the press
conference was that the average reading performance of our
fourth graders had been flat. This is shown in this chart
showing NAEP reading test scores for 4th graders from 1984-
1999.
Flat Reading Performance
Now, if you bear down inside that statement that the
average performance is flat, you find that that result is from
the better students getting better and the worst students
getting worse. The net result being flat reading scores.
But if you look at it from a deeper perspective, even, the
students who are doing worse are exactly the students who this
bill was created to help. That is even more devastating.
So, flat performance is not good enough. And so, it
requires change.
The results of that reading assessment are even more
disconcerting when we look at it from the point of view of our
disadvantaged students.
I am sorry to tell you that among students taking the 4th
grade reading exam, ethnically, they are dividing themselves;
economically, they are dividing themselves. Despite Federal
programs designed to help the disadvantaged students, that is
exactly the group that is doing worst.
There is a decade of historic increases in funding that
supports this. We are not doing the right things or we are not
doing things right.
ESEA Spending and 4th Grade Reading Achievement
The story of our investment in education can be illustrated
by this graph which shows 4th grade NAEP reading test scores
for 1984-1999 and the Federal ESEA investment over the same
period. It speaks for itself. Now, promoting the continuation
of that seems to me to be inappropriate.
ESEA Spending and 4th Grade Math Achievement
The story of our student performance in mathematics can be
illustrated by this graph.
Federal ESEA Investment and Student Achievement
The charts make powerful arguments to stopping, to pausing.
Let us stop and take a look at what kind of results we are
getting and think about doing something different.
I want to say here that I know that everybody shares my
passion, the Senators' passion, and all our passion about
fixing these things, but I am just trying to call your
attention to what is happening.
The story of our students' performance tells the story.
Perhaps the most powerful one is the chart showing reading
achievement for the 4th graders as measured by NAEP test scores
and compared to the Federal ESEA investment. The blue is the
spending. The red is the performance. The connection between
those points do not seem to connect. It argues, for me, to let
us take another look.
Creating a culture of achievement
I give everybody credit for wanting to do things to improve
student performance. Federal funds have been forthcoming. To
understand this better, I went back and read the arguments for
and against the ESEA bill in 1965 and each reauthorization
thereafter. I read the Congressional Records, the reports and
looked at those who argued for and against various points of
views. I can tell you, from that reading, that we are circling
and making the same arguments and getting the same results.
While Federal funds have been forthcoming, student
performance has stagnated on the average and declined among the
hardest to reach students. The students who we are supposed to
be reaching through Title I and other Federal programs are
precisely the kids that are hurting.
Our system is a system that has allowed elementary and
secondary student performance to stagnate, while in the last
few years, the spending increase has averaged 17 percent. And
when we spend, we think that we have conquered. When we spend,
we think we have had victory. And we measure success by how
much we spend.
And I am not telling you things that are new. These things
have been said before. The General Accounting Office in 1998
said, and I quote, ``The clearest evidence about a lack of
positive effect from Federal expenditures comes from one of the
largest programs, Title I. Title I of the Elementary and
Secondary Education Act is the largest Federal elementary and
secondary education grant program. Children in high-poverty
schools began school academically behind their peers in low
performance schools and could not close these gaps as they
progressed through school. In addition, when assessed according
to high academic standards, most Title I students failed to
exhibit the reading and mathematics skills expected of their
respective grade levels.''
This is the goal we said we were going to accomplish in
1965. I can say that from reading the history.
Now, what should we take away from this lesson? Simply put,
we know that spending more on the same thing is not the answer.
We need to do things differently to adopt a culture of
achieving in our schools and school systems, and to demand
results from our growing investment. We also need to continue
to invest in those enterprises that work.
Guiding Principles of Education change
And I am proud to appear before you on behalf of the
administration's budget to make the point about some principles
that work. I know they work. I personally participated in them.
Houston Independent School System
I used them to improve the seventh largest public school
system in the United States that resides in the fourth largest
city in the United States that is populated by poor children.
The school district that has converted itself from a district
with minorities to a district of minorities; a district with 73
percent free and reduced lunch eligible students. These simple
principles----
Senator Reid. I did not understand that. Seventy-three
percent of what?
Secretary Paige. Seventy-three percent of the 210,000 to
215,000 students are eligible for free and reduced priced
lunches, which is a criterion or indication of being poor.
And by the way, it is probably higher than that, because we
know that middle school students and high school students,
traditionally, do not register for free and reduced priced
lunches, even though they are eligible in many cases.
ESEA Reauthorization
You and your colleagues are in the midst of a critical
debate over the reauthorization of the Elementary and Secondary
Education Act and the substitute to be offered by Senator
Jeffords, the Better Education of Students and Teachers Act.
That is pending before us, now.
Principles of Educational Change
I will not bore you with these principles, because I know
that you have heard them before. I will just briefly list
them--accountability, flexibility, allowing the principals at
the--the principal and the other people, not just the leader of
the school--but all the people at the site to make decisions
and to have control over matters, doing things that work, not
funding failure.
Many people are doing the same thing over and over again.
When I became superintendent of the Houston Independent School
District and looked at the Title I programs, we had to call a
moratorium on doing the same thing, and to say, ``If you did
this last year and this is your results, we are not going to
allow you to do it this year.''
And so the momentum of this continue-to-do-the-same-thing
is so powerful, that it takes effort to stop it and put
something new there. And this is not about money. It is okay to
spend all the money in the world we have got, but it is about
our children, who are not gaining with this principle. That is
the point.
The budget is the argument, but the point is our students
are not growing. And we need to figure out a way to deal with
that.
Reading is a particularly difficult problem. It is the
foundation of learning. And when students cannot read, the rest
of it is all of no value.
Expanded parental options. We could argue politically about
this. And there is no reason to beat a dead horse, but nobody
has answered the question, what do you intend to do with
students who are failing in a failing school? If a school has
failed and failed and failed, what do you intend to do about
the students?
The only answer I have heard is: Continue to fix the
school. Favor the system over those kids. I argue passionately
against that--I do not think any principle is more important
than fixing the kids.
Failing Schools--Cumulative Effect of Achievement GAPS
When we look at the Sanders' study, it tells us that these
kinds of gaps are cumulative, which means the student who has
an ineffective teacher for 1 year, and then the second year has
a very effective teacher, still the gaps created by the
ineffective teachers cannot be covered up. This gap is
continuing. So, we go through 2, 3 years of ineffectiveness?
What do we intend--what do we do with the students who are not
growing in this environment? It seems to be the most important
question we could ask.
You know the numbers better than I. So, I will not bore you
with these numbers. I will quickly bypass them and go to the
end of this presentation.
Debate Reform and Principles of Reform, Not Budget
I know the President has provided in his budget expanded
funds. And I believe that he is amenable to increasing the
spending of funds, but the question is not allowing the
discussion to be switched from reform. Reform is the issue.
Funding is not the issue. If funding were the issue, we would
not be arguing now. Reform is the issue. The debate is about
reform, not about funding.
I am about finished. Overall, you know the numbers in the
President's budget better than I, but I do want to emphasize
that the President has put terrific emphasis on the critical
skill of reading. And we intend to make that work.
I referred, already, to the charts that you saw before you,
but I want to do so, again, because I want to underscore that
if money alone were the answer to our education dilemma, we
would not be here today.
You are considering this budget in the context of a debate
about reform. And that will make all the difference in the
world for our children. The same is not true for other
Department of Education programs, other than elementary and
secondary programs. Money alone will not result in a system
change. And no matter how much we spend, we cannot measure
success that way.
I urge you to give the President's reform proposals very
careful consideration. And I will end by making this
observation--and I apologize, at first, for continuing to refer
to myself as a Houston public school administrator. I was
drafted for that job. I did not ask for it. But once I had
accepted the responsibility for the management of that system,
the seventh largest public school system in the world, I was
intent on making it work.
And it was disconnected from the public. By that, I mean
the public had very little confidence in this system. And for
3--no, 4 straight years, we did not go back to the public, we
decided not to ask the public for additional funds. So, there
was no tax increase at all, although we grew, the public
schools student population grew.
I want to make the point that we can reform the system
without going back for additional dollars; using inside funds;
redistributing these funds, and using them in a more effective
way.
And after 4 years of that--each year, coming back and
showing improvement as we went--when we did have to go back to
the public to build buildings, we were successful in raising
the funds. The public had turned down a $391 million bond issue
3 years earlier, which was the greatest lesson in my life,
because if they had passed that bond issue, I would have spent
3 years building buildings.
They defeated that bond issue and I spent that next 3 years
building the confidence of the public in the public school
system. I spent 3 years building relationships. And I spent 3
years building productivity and efficiency inside the system.
And 3 years later, I went back to the public with a bond
issue twice that size, with $678 million, the largest ever in
the history of our State, and said, up front, ``It will cost
you 5.5 cents on the tax rate.'' And in Texas, you do not say
``taxes.'' We stood out, publicly, and said it loud.
Seventy-three percent of the public voted to support that
bond issue. All segments of the public; people who did not have
children in our schools; from both sides of the political
spectrum; from labor and from management, every segment
supported it, because they had confidence in what we were
doing.
Houston School System Reforms and Public Opinion
Senator Specter. Mr. Secretary, what reforms did you
initiate in the interim to lead to that change in the public
attitude?
Secretary Paige. The first reform, Senator, was to accept
responsibility for student learning. It was to hold people
accountable and to administratively arrange a relationship
between the leaders of our schools--the managers, the
principals--and connect in that way to increase their
productivity; rearranging their contracts, so each had
contracts just like I had, which almost was a public service--a
public sector contract, because the board could change it at
any moment. They did not have the political cover of going to
their board members or other people like that. That was the
first one.
The second one was to set real clear, crisp standards and
continue to remind them of those standards. In every school
that you went to, there was a graph on the wall saying, ``Here
is where you are, now. And here is where you are going to be 4
years from now. And here is what annual progress means, where
you will be next year.''
So, we listened to the public, talking to the community
groups, the business community, the faith-based community, the
ethnic groups, NAACP, LULAC, all of those, getting all of these
people involved.
I do not mean to imply that we licked this thing. I am just
saying that we had progress and the progress was built on the
common practice of listening. We stopped talking about money,
started talking about productivity, and showed the results to
the public.
And by the way, even when we made mistakes, we would go to
the public and say, ``We made this mistake.'' We stopped making
excuses about mistakes. When something went wrong, we stood up
in front of them and said, ``We did this wrong. We will do it
better.''
We did a lot of different things, like simply taking
responsibility, setting high standards, measuring results,
reporting those results to the public, calling our
administrators in and letting them know feedback on how they
were performing.
Prepared Statement
Senator Specter. Mr. Secretary, your full statement has
been received by the committee and has been studied and fully
made a part of the record, if it is acceptable to you.
Secretary Paige. It is.
[The statement follows:]
Prepared Statement of Dr. Roderick R. Paige
Mr. Chairman and Members of the Committee: Thank you for this
opportunity to testify on behalf of President Bush's 2002 budget for
the Department of Education. As you know, the President has made
education his highest priority, and this priority is reflected in his
2002 budget request.
The reason for this is simple: there is nothing more important for
the future of this great Nation than the education of our children.
Unfortunately, our system of education is failing too many of those
children. Earlier this month, the latest results of the National
Assessment of Educational Progress (NAEP) showed that the average
reading performance among our fourth graders has not improved since
1992. And when 37 percent of our 4th-graders--and nearly half of inner-
city 4th-graders--are unable to read at even the NAEP Basic level, our
education system is broken and needs repair urgently.
President Bush and I are especially concerned about the persistent
gaps in achievement between poor and minority students and their more
advantaged peers. For example, the NAEP results showed that in 4th
grade reading, 73 percent of white students performed at or above the
basic level, compared with just 42 percent of Hispanic students and
only 37 percent of African American students.
This disappointing performance comes after nearly two decades of
national attention on education reform and a dozen years of rapidly
increasing Federal spending on elementary and secondary education.
Simply spending more money in the same way is not the answer. We need
to do things differently, to adopt a culture of achievement in our
schools and school systems, and to demand results for our growing
investment in education.
That's why I'm especially proud of the President's 2002 budget
request for education. It provides a budget authority increase of $4.6
billion, or 11.5 percent--the largest increase of any cabinet-level
agency--and a $2.5 billion or almost 6 percent increase over the 2001
program level. This increase is particularly impressive in the context
of the President's overall effort to restore discipline to
discretionary spending over the next decade while delivering an across-
the-board tax cut benefiting all American families.
Even more important, these new dollars are focused on changing the
culture of our education system and closing the achievement gap. Our
budget reflects the principles put forward in No Child Left Behind:
high standards; annual testing of all students in grades 3-8 in reading
and math; increased accountability for student performance; a focus on
research-based practices--particularly in teaching reading; reduced
bureaucracy and greater flexibility for States, school districts, and
schools; and expanded options for parents to make choices for their
children's education.
closing the achievement gap
President Bush believes that the Federal government can, and must,
help close the achievement gap between disadvantaged students and their
peers. The primary means toward this goal is the Title I Grants to
Local Educational Agencies program. We are requesting $9.1 billion for
this program, an increase of $459 million, to give States and school
districts financial support to turn around failing schools, improve
teacher quality, and ensure that all students meet State academic
standards before advancing to the next grade.
No Child Left Behind provides a new framework of accountability for
ensuring that the Federal investment in Title I is well-spent and
delivers the results intended when it was first authorized 36 years
ago: closing the achievement gap between poor children and their more
advantaged peers. The foundation of this new accountability framework
is annual State assessments in reading and math for all students in
grades 3-8, instead of the current law requirement for testing only
twice during these critical formative years. The President's budget
provides $320 million to help States develop and implement these
additional assessments.
I know many in Congress have concerns about these new assessments,
but I can tell you from my own experience that there is no substitute
for annual information on how well students and schools are performing.
Children in good schools make remarkable progress during these early
grades, and we cannot afford to wait three or four years to find out
that some students have fallen behind. Where there are problems, they
must be discovered and addressed immediately, an approach that can only
be accomplished with the information provided by annual testing.
Moreover, these tests are essential if we are to set clear goals
for performance and help our schools get the job done. The alternative
is to continue to rob millions of poor and disadvantaged young
Americans of their futures by failing to provide them an effective
education.
The important thing about testing, of course, is what we do with
the results. We would start by helping teachers learn to use data
effectively. Secondly, we would require schools to report assessment
results for all students to parents and the public. School districts
would use these results to make sure that all schools and students are
making adequate yearly progress toward State content and performance
standards, and that no groups of students are left behind.
Under No Child Left Behind, schools would be identified for
improvement after just one year of failing to meet State standards. And
unlike the current system, where about half of schools identified for
improvement receive no additional assistance from their State or
district, we would require States and school districts to provide these
schools with technical assistance grounded in scientifically-based
research. The $9.1 billion request for Title I Grants to Local
Educational Agencies includes $400 million, an increase of $175 million
or 78 percent, to help pay for these efforts to turn around low-
performing schools.
If the school still has not improved after two years, it would be
identified for corrective action and subjected to more comprehensive
measures, such as implementation of a new curriculum, intensive
professional development, or reconstitution as a public charter school.
While such measures are underway, students would be given the option of
attending another public school not identified for improvement or
corrective action.
Only after all these efforts, and following three full years of
poor performance--during which time a student may well have fallen
behind a grade or two--would we use Federal funds to help that student
find a better education at a private school. We are proposing to permit
the use of Title I funds to help students transfer to a higher
performing public or private school, or to obtain supplemental
educational services from a public- or private-sector provider. I know
there are disagreements about methods of reform, but surely everyone
can agree that no child should be trapped in a persistently failing
school.
Taken as a whole, these proposals reflect what I believe is a
strong consensus, both within the Congress and among the American
people, that States, school districts, and schools must be accountable
for ensuring that all students, including disadvantaged students, meet
high academic standards. At the same time, we recognize that it is
unfair to demand accountability without enabling success. This is why
the 2002 budget supports other proposals in No Child Left Behind that
would give States, school districts, schools, teachers, and parents the
tools and flexibility to help all students succeed.
For example, the President's Reading First program would help
States and school districts implement comprehensive reading instruction
grounded in scientifically-based reading research for children in
kindergarten through third grade. The budget includes $900 million for
Reading First State grants, more than triple the 2001 level for reading
instruction. The request also would provide $75 million for Early
Reading First, an initiative that would complement Reading First State
Grants by supporting model programs to develop the academic readiness
of preschool-aged children. Over 5 years, the President would invest
more than $5 billion to ensure that every child in America can read by
the 3rd grade.
We also are requesting $846 million for 21st Century Community
Learning Centers to support a State formula program that provides high-
quality extended learning opportunities after school and during the
summer, particularly for children in high-poverty and low-performing
schools. And a $30 million request for our Transition to Teaching
proposal would help school districts recruit, prepare, and support a
wide range of talented career-changing professionals as teachers,
particularly in high-poverty schools and in high-need subject areas.
empowering parents with choices
President Bush and I believe that one of the best ways to improve
accountability in our schools is to give parents the information and
options needed to make the right choices for their children's
education. This is why, for example, the accountability proposals in No
Child Left Behind include school-by-school report cards and give
students in failing schools the option of transferring to a better
school. In addition, the 2002 budget request includes the following:
The President is proposing to increase the choices available to
parents through a new $175 million Charter Schools Homestead Fund. The
program dollars will be used to provide grants to leverage funds to
build, lease, purchase, or renovate facilities for use by charter
schools. A $200 million request for the regular Charter Schools
programs, an increase of $10 million, would support approximately 1,780
new and existing charter schools that offer enhanced public school
choice and have the flexibility to offer innovative educational
programs in exchange for greater accountability for student
achievement.
The President is also proposing a tenfold increase in the annual
contribution limit for education savings accounts, from $500 to $5,000.
Parents would be able to make tax-free withdrawals from these accounts
to pay for elementary, secondary, college, and after-school program
expenses at both public and private schools.
expanding flexibility and reducing bureaucracy
The Administration believes that it is possible to achieve better
results by reducing regulations, paperwork, and bureaucracy and giving
States and communities the flexibility to create their own innovative
solutions to challenges in education.
For example, the $2.6 billion State Grants for Improving Teacher
Quality proposal would combine funding from several existing education
programs, including the Class Size Reduction and Eisenhower
Professional Development State Grants programs, into performance-based
grants. The proposal would provide a $375 million or 17 percent
increase over the antecedent programs to help States and local
educational agencies (LEAs) fund their own needs and priorities in
developing and supporting a high-quality teaching force.
Similarly, the $817 million Educational Technology State grants
proposal would consolidate all of the Department's current educational
technology programs into a single, performance-based grant program to
ensure that schools use technology effectively to improve teaching and
learning. And our $472 million request for Choice and Innovation State
grants would combine overlapping and duplicative programs into one
flexible grant program to help States and school districts implement
their own innovative strategies, including school choice, for improving
student achievement.
other key elementary and secondary proposals
The President's budget includes a $1 billion increase for the
Special Education Grants to States program, for a total of $7.3
billion. This is the largest increase in this program ever requested by
a President, and would provide an estimated $1,133 for each child with
a disability. That is approximately 17 percent of the national average
per-pupil expenditure--the highest level of Federal support ever under
the Individuals with Disabilities Education Act.
We also are requesting $644 million for Safe and Drug-Free Schools
State grants to provide students with more effective drug- and
violence-prevention programs and to implement strategies to improve
school safety. No Child Left Behind includes proposals designed to
strengthen the ability of schools and teachers to prevent violence in
our schools, and our budget proposal would provide flexible Federal
resources to help make our schools safe and drug-free.
The President's Budget also supports a significant increase in the
Impact Aid program, which provides financial assistance to school
districts afffected by Federal activities. The $137 million increase
for Impact Aid Construction would greatly expand support for the
renovation and repair of schools that serve large proportions of
military dependent students and students residing on Indian lands.
In addition to our discretionary request, the President's budget
includes tax proposals that would significantly benefit elementary and
secondary education. I have already mentioned our plan to expand tax-
free Education Savings Accounts to increase the educational choices
available to parents. Another key proposal would allow States to issue
tax-exempt private activity bonds for constructing public elementary
and secondary schools. Current law does not exclude from income the
interest on such bonds used to finance school construction. Private
entities would construct, own, and maintain the schools.
We also would allow teachers and other elementary and secondary
school professionals to treat up to $400 in out-of-pocket classroom
expenses as a non-itemized, above-the-line deduction beginning in 2002.
Expenditures for books, supplies and equipment related to classroom
instruction and for professional training programs would qualify for
this deduction.
postsecondary education
No Child Left Behind is focused on elementary and secondary
education, but the 2002 request also demonstrates the President's
commitment to preparing low-income and minority students for
postsecondary education, strengthening financial aid programs that help
students and families pay rising college costs, and building the
capacity of postsecondary institutions serving large proportions of
minority students.
For example, we are proposing a $1 billion increase for Pell Grants
to support a maximum grant of $3,850--the highest ever--and to improve
access to postsecondary education for economically disadvantaged
students. Overall, the President's budget would support a total of more
than $49 billion in student financial aid, an increase of $2.2 billion
or 4.6 percent over the 2001 level, for an estimated 8.2 million
students and parents.
To help low-income students prepare for, enroll in, and complete a
college education, we are requesting a $50 million increase for TRIO
outreach and support services. We also are seeking a $15 million
increase for Historically Black Colleges and Universities and a $4
million increase for postsecondary institutions that serve largely
Hispanic populations.
We would encourage more college students to pursue teaching careers
in high-need areas by expanding loan forgiveness for math and science
teachers serving low-income communities from $5,000 to a maximum of
$17,500.
We also would permit tax-free distributions from Qualified State
Tuition Plans (QSTPs) to pay higher education expenses, including room
and board, tuition and fees, and certain expenses for books, supplies,
and equipment. In addition, private educational institutions would be
permitted to establish qualified prepaid tuition plans, provided they
are eligible to participate in Federal financial aid programs under
Title IV of the Higher Education Act of 1965.
conclusion
The President's 2002 budget request for education, in tandem with
the education reform proposals contained in No Child Left Behind,
support a comprehensive vision for closing the achievement gap and
improving the quality of education for all Americans. I urge you to
give these proposals careful consideration, and I stand ready to answer
any questions you may have.
Senator Specter. I would like to begin, now, the round of
questioning by the Senators.
Secretary Paige. Thank you.
Senator Reid. Mr. Chairman, if the chairman yields, I would
ask consent of the subcommittee that I be allowed to submit my
statement for the record and questions. I am going to have to
depart for other places.
Senator Specter. Your statement will, without objection, be
made a part of the record. Are you asking to question out of
turn?
Senator Reid. No. I do not want to question out of turn. I
will submit some questions in writing.
Senator Specter. Of course. Of course, Senator Reid. That
will be acceptable. And I am sure the Secretary will respond in
writing.
[The statement follows:]
Prepared Statement of Senator Harry Reid
I want to thank Chairman Specter and our distinguished Ranking
Member, Senator Harkin for holding this hearing on the Department of
Education's budget.
Education is so vitally important--it impacts every aspect of our
lives. There are, therefore, many issues I could discuss with you
today, but I will focus on only a few.
I am troubled by the fact that the budget that President Bush sent
to us--and the budget that he has asked Secretary Paige to defend--
--has nothing for school construction,
--has no increase for after school programs,
--has no targeted class size reduction funding, and
--has nothing for dropout prevention.
Senator Bingaman and I have long supported a national dropout
prevention program. Last year, Congress recognized the importance for
such a program and we included funding in the appropriations bill. This
year, we have again introduced our bill, S. 102, the Dropout Prevention
Act.
The aim of this bill is to encourage innovative thinking by the
States and local school districts regarding dropout prevention, and to
provide the funds if schools wish to start a similar program in their
school. To help restructure the schools with the highest dropout rates
in each State, this legislation would create a coordinated national
dropout prevention program.
Over half a million high school students drop out each year,
joining almost 4 million young Americans who lack a high school degree
and are not in the process of getting one. Unemployment rates of high
school dropouts are more than twice those of high school graduates.
--The probability of falling into poverty is three times higher for
high school dropouts than for those who have finished high
school.
--If we do not address the dropout problem in this country now, we
will be faced in the future with a weak and uneducated
workforce.
--By keeping kids in school, we are attacking much larger social and
economic issues.
Earlier this year, I was pleased to learn from Secretary Paige that
he supported a similar program when he was in Houston.
The Education bill that we have on the floor right now authorizes
$250 million for the dropout prevention program. I urge the Committee
to fund this program and I urge the Secretary and the President to
support such funding.
Thank you.
School Construction funding
Senator Specter. Mr. Secretary, let me begin the round of
questions. We do not have the lights on, which is a little
difficult, because--not for you, Mr. Secretary, but for the
members that cannot see when it is turning to yellow and when
it turns to red. So, we will hand members slips when we come to
4 minutes and when we come to the end of the time. And as is
our practice, I, as Chair, will begin the round of questioning.
And let me start with the issue of school construction,
which is going to be a matter to be voted upon by the Senate.
And there are differences of opinion, different gradations. And
the National Center for Education and Statistics, in a 1999
study, found that $127 billion was needed for repairs,
renovation, and modernization of America's schools.
Now it is true that the lion's share of responsibility is
on the State and local government, but the prior administration
had a program for school construction. It ended up, last year,
differently from my preference. My preference was to direct the
funds, about $1.3 billion, for school construction, but if the
local boards met certain standards, then to have flexibility
and allow the local boards to do what they chose with that
money and not use it for school construction.
Federal Role and School Construction
Now, I have a two-point question for you, Mr. Secretary, on
this subject. If the Federal Government is not to take a
leadership role in school construction, and knowing that the
States and local governments have allowed the school buildings
to deteriorate, where will we find some relief? Let me start
with that question, without adding a second.
Secretary Paige. Mr. Chairman, I have to agree with you
that the condition of our buildings across the United States is
really deplorable in the main. And I guess at some point we
would be benefited by a great debate about what the Federal
role is in public education. I am not taking any particular
position on that, now.
In fact, when President Kennedy--I mean, President Clinton
proposed the legislation on school construction several years
ago, as a big city superintendent I came to testify in favor of
the bill, because that----
Senator Specter. Is that still your position?
Secretary Paige. No, it is not. And it was because I had a
construction problem in Houston. And we had calculated that we
would get somewhere in the neighborhood of $200 million, or
something like that which would have been there to help us. We
needed it badly. And it was my position, then, that that was
something that we should do.
So, I can understand, clearly, people arguing both sides of
this, but----
Senator Reid. Mr. Chairman, but he is not for or against it
at this stage. Is that what he said?
Senator Specter. He is against it. He had been for it, as
superintendent of the schools of Houston, but as Secretary of
Education, he is against it.
Now, why, Mr. Secretary? Because you think it is not the
Federal role?
Secretary Paige. Well, that is--that is one thing, Mr.
Chairman. I think that we need to examine to determine where
the Federal role starts and ends, because I do not know if the
Federal Government is capable of managing this one.
Here is my rationale. The $1.2 billion that was allocated
for this purpose, under the previous administration, would not
have repaired the buildings in the Houston Independent School
District 3 years ago. So, today, it would cover, maybe, 75
percent of them.
Senator Specter. Well, how about the leadership role of the
Federal Government, Mr. Secretary? If we--my idea in the
current bill is to have an allocation for school construction,
but if the local boards decide that they have some greater
need, to give them the flexibility.
So, in effect, it is a rebuttable presumption. And it
provides some continuity, even though we do not have the
Clinton administration, we have the Bush administration, but to
meld the two on some central ground and say, ``We would like to
continue this, but it is up to you, if you think you need the
money somewhere else more urgently.'' Why not that approach,
Mr. Secretary?
Secretary Paige. Well, Mr. Chairman, I am not prepared to
debate that approach, because I think there is some thought
behind that. And I think there is great merit there. However,
it differs a little bit from my point of view, because my point
of view is about managing the construction issue from this
level. And it is going to be extremely difficult.
How do we choose among these great needs all the way across
the United States?
Senator Specter. Well, we certainly have the--let me move
to the other question, because I have got 20 seconds left, and
that will be time for me to state the question and you can give
the answer, but not on my time.
Flexible Teacher Fund and Class size reduction
Teachers. The same thing. $1.3 billion last year. Class
size. Senator Murray has offered an amendment. And I have made
what we call a second-degree amendment to make it presumptive,
yes, for teachers, but again, if the districts decide something
else, they can do as they choose.
My red light is on. I am nine seconds over. Now, we will
listen to your answer, Mr. Secretary.
Secretary Paige. Okay. Was that last point about the
teachers? Class size reduction was to increase more teachers?
Senator Specter. Yes.
Secretary Paige. Allow me, once again, to rely on my
experience. Okay. When we looked at that from Houston's point
of view, the first thing we found out was that we had no space
to add additional classrooms for the additional teachers.
The next thing we found out was the funds would only pay
salaries of first-year teachers. So, that further handicapped
us. The district and the State had already reduced class sizes.
So, we were handicapped in that regard.
We wanted to use those dollars to ensure improved student
achievement, but the regulations were so stringent that the
flexibility to do that was difficult.
Now, I will confess, now, that we got around it, but the
way we got around it, I would say, was dubious. We went around
by using a very crisp understanding of what the regulations
said and getting ready to debate that at some point, because we
thought that we might get it done that way, but the regulations
tied our hands. We found a way to use the money, but the
regulations tied our hands.
We would have been better off if it had come to us the way
that it is packaged in the President's budget now, with $2.6
billion for teacher quality, which allows the district to make
decisions about how to increase teacher quality. We should not
just take the concrete, specific, limited concept that if you
have more teachers, the situation is better.
It is much more complicated than that. And it is tied
almost exclusively with teacher quality. Are the additional
teachers better, or are they worse? Can you get better
teachers?
We would like to use the money, maybe, to take the teachers
we have and send them off to be trained. Or we may like to take
some of the money to go to Mexico and to recruit more teachers
who have dual language capabilities. You cannot know that. Only
we could know that.
So, the flexibility to use those dollars, as it is packaged
in the President's budget, is much preferable to all of the big
city superintendents that I have talked to and all of the rural
superintendents that I have talked to.
Senator Specter. Senator Harkin.
School Construction Funding
Senator Harkin. Thank you very much, Mr. Chairman.
Mr. Secretary, permit me, a little, to tarry along the
construction situation.
Secretary Paige. Okay.
Senator Harkin. I first started proposing this in 1991, and
then in 1992, and then in 1993. And finally, in 1994, when I
held the chair that Senator Specter does now, and he was
ranking member, I got through $100 million in appropriations to
put out a pilot program for construction. That was 1994.
In 1995, the Clinton administration rescinded it. So, there
you go. You can say now you agree with the Clinton
administration. He rescinded it. I was furious. Furious. It was
not the Republicans that did it. It was the Clinton
administration that rescinded it. You know that as well as I
do.
So, I tried again, year after year, to get this thing going
again. Finally, dragging, kicking and screaming, we got the
administration to support it last year. And we got $1.2 billion
into school construction. And I have got a list of how much has
gone out to the States.
That is just a little bit of the background for you, where
this is coming from.
In the meantime, after the President rescinded that in
1995, I said, ``Well, I believe this will work. There is a
great need, and it will work.''
So, for 3 years in a row, we got money through the
Appropriations Committee to go to my State of Iowa for
construction grants. It went to the State Department of
Education with broad guidelines. We did not give them every jot
and tell them exactly how to do it.
We just said, ``Here is the money. Broad guidelines. Target
the poorest school districts.'' That is all we said. So, it
went out to the Iowa State Department of Education.
Leveraging Federal Funds--School Construction in Iowa
Now, Mr. Secretary, $28 million has gone out to Iowa for
that. Now, hang on to your hat. That $28 million leveraged $311
million on the State and local level.
One of the things that we know about the Federal Government
is, sometimes money can leverage money. And anytime you get 10
to 1 leverage on Federal dollars, something is happening out
there.
What the State Department of Education said was, ``We will
do matching on it. And you can raise money through a bond
issue, sales tax.'' We have local option sales tax for plant
and equipment, the different things that local units of
government can do in the State of Iowa.
With that little bit of money--with that little bit of
money, they stepped forward and did it, and leveraged it over
10 to 1. And I have got the data to prove it.
You said two things. The Federal Government is not capable
of administering this.
Secretary Paige. No. I mean----
Senator Harkin. Well, I wrote it down.
Secretary Paige. Yes. I probably did say that, but I mean
solving this problem. I did not mean administering.
Senator Harkin. Oh, well, you said ``administering.'' I
just want you to know, we did not administer it in Iowa. We let
the State Department of Education in Iowa do it.
Secretary Paige. Yes.
Senator Harkin. And the legislation that we have now, the
same thing; that would be our guideline. It is going to go out
to the State Departments of Education in Pennsylvania and
Washington and every other place. And we are just going to give
them a broad guideline, target it to the poorest districts----
Secretary Paige. Yes.
Senator Harkin [continuing]. And let each State do it in
their own way. So, we do not have a problem of administering
it. It is administered in Iowa by the Iowa Department of
Education. And it has made a huge difference. Go out and ask
those school districts out there what it has done in terms of
leveraging that money.
So, when you talk about $1.2 billion will not repair three
of your schools in Houston, when it all factors out, that is
probably true, if you are talking about the totality, but think
about it in terms of how much it leverages out there. If we can
just get two-thirds of that leveraging nationwide, from $1.2
billion, you are talking about $7 billion, $8 billion, $9
billion. Now that makes an impact.
So, there is a history here to this. And there is some
proof of concept out there that we have gone through. And that
is why I hope that your initial support of this, you would
revisit, and come back again, Mr. Secretary.
Secretary Paige. Well, that is what I want to do, Senator,
to put emphasis on our education situation.
And by the way, I would like the record to show that, if I
am permitted to, I do not mean administering. I used the wrong
word there. What I mean was solve it. I meant that this problem
is so vast it is going to need the locals to address it, as you
have indicated that they are doing.
Senator Harkin. They do have to address it, obviously, but
we are going to give them a little bit of help to move them
along. That is the leveraging aspect of that money that goes
out there.
Impact aid Construction
Secretary Paige. But there is a place where we have the
direct responsibility. And I think the Federal Government has a
direct responsibility for school districts that are impacted by
military enrollment of our students. I think that is a primary
direct responsibility of the Federal Government in terms of
construction.
And when we look at the conditions of the buildings in
those locales, I think that we find that we have an even
greater problem there.
And the second one would be on Indian reservations. It is
those areas, where I would agree that we need to have a
specific Federal focus on the construction of buildings.
So, there is not that much difference here in the argument.
There are places where we have direct responsibility that I
think we should take care of first.
Senator Harkin. Well, I agree that we need to do something
in those areas, but--on the school districts in the military
and stuff, why should that not also come out of the Defense
budget? Why do we have to take that out of the Education
budget? Put it in the Defense budget. That is where it ought to
be done. That is my response to that.
We have got an obligation. You are right. But I think this
is a military obligation that they have.
Thank you, Mr. Secretary.
Secretary Paige. Thank you.
Senator Specter. Thank you very much, Senator Harkin.
Secretary Paige. Thank you for your passion in this matter.
I know it is important to you.
Senator Harkin. Yours, too. Yours, too. You have got good
passion, too.
Senator Specter. Senator Murray.
Senator Murray. Thank you, Mr. Chairman.
And clearly, Secretary Paige, you have a passion for making
sure that all of our students get a good education. And I
really commend you on that. And I have spoken to you a number
times on this, both in my capacity on this committee and on the
Authorizing Committee. And I appreciate your being here today
and showing us, once again, your passion.
I have to just quickly add on school construction--that I
am delighted to hear you say that we should be funding military
impacted schools, because I have been fighting to help some
impacted schools in my State and cannot get anything from the
Defense Department on this. They absolutely say it is hands-
off. And I agree with Senator Harkin that this is an issue we
need to deal with, but it is an issue we need to deal with for
all children.
Let me go back to the issue of class size. The Chairman
began this hearing with a question on this, and I heard your
response about hiring only first-year teachers. The only
requirements within the class size bill is that teachers hired
are fully qualified, not that they are first-year teachers.
So, I am not certain where you were coming from on that,
but I can certainly tell you if there is a misunderstanding
with that, then we need to deal with the language. Let us not
throw the program out. Let us figure out what the language
needs to be.
And second, we have worked very hard with Senator Specter,
Senator Harkin, and a number of people on both sides of the
aisle to develop language for the very successful class size
program, to assure that it is flexible; that if a school
district has met their class size goals in first, second and
third grade, then the money can be used for teacher training
and for other purposes.
And I want to thank Senator Specter, publicly, for his
interest in this. I have seen his second-degree amendment. And
I hope we can work something out on this, because I think that
as we see the studies that come to us, we see the progress that
has been made on class size, we see that this is a way to
leverage Federal taxpayer dollars to actually make a difference
in students' achievement; in their math, in their science, in
their reading scores.
We have seen, through various studies, that smaller classes
make a difference in dropout rates and the number of students
going on to college, and even teen pregnancy rates, even if it
is just in those first, second and third grades, where our kids
are just beginning to learn the basics, that they get the
individual attention they need. And yes, it is the
responsibility of the Federal Government to be a partner, to
make sure that our local school districts have the ability to
create smaller classes.
In fact--I have to say, I am sort of baffled by your
conversion, as Secretary of Education, from where you stood on
this issue were as Superintendent of Houston schools, because I
know that in presentations by your advisor, Susan Sclafani,
about how Houston closed the achievement gap, certainly setting
out the goals and where you wanted kids to be--and telling
people they had to be accountable was part of it.
But clearly, she has said that targeting assistance to low-
performing schools was important--and she specifically has
said, that adding teachers to lower pupil-teacher ratio was a
critical part of making sure that those students achieve.
We believe that closing the achievement gap is a laudable
goal, and one that many districts are struggling to reach. The
class size dollars that we have put in place over the last 3
years have come back to us, triple-, quadruple-fold from
results in districts where teachers and parents and students
are saying what a tremendous difference smaller classes have
made for them.
Because I have been on a school board, I know how hard it
is to find the funds for long-term commitments like hiring more
teachers. I know how many demands there are when it comes to
budget time.
The Federal class size dollars go directly to these school
districts with the least amount of paperwork and the most
flexibility, ensuring that students are able to get the kind of
help they need. And we want to continue to leverage that. And
we want to continue to build on that success. And I hope that I
can work with you to make that happen, because I think it is
absolutely critical to our children's success.
And I hope you can comment on that really quickly, because
I do have a very important question about the chart that you
have.
Secretary Paige. Well, Senator, you make a very powerful
argument. I find very little in your comments to disagree with.
My only point is the categorical nature of the way the dollars
are provided for the system.
I believe the people on the scene should be able to make
the decision on how those dollars are used. And we should
provide them with the total flexibility to----
Senator Murray. I know you have said that before. And I
appreciate that, but I would remind all of us that there are a
number of targeted funding streams in the President's education
reform proposal, including Reading First, Technology, After
School Programs, and Charter Schools. This is where the
Administration has said, ``We do believe targeted funds make a
difference.''
I am passionately telling you I believe that there are
other areas, as well, including class size.
Secretary Paige. That I think has an important role to
play. We are talking about how broad or how narrow it is. And I
thought that the teacher class size reduction legislation, the
previous legislation, was too narrow.
I thought that it was too restrictive. And I would have
preferred, as an administrator, the flexibility of using my
judgment on the scene, on determining how I could improve
teacher quality. But the broadness of the teacher quality is--
--
Senator Murray. We would disagree on that.
Secretary Paige [continuing]. What we are talking about. I
think that, clearly, you know that I agree with the--that
smaller is better, given just that--if you just think of that.
But it is not that narrow. It is much more complicated than
that.
Senator Murray. Well, I disagree.
Secretary Paige. So, I am just arguing about the narrowness
of the legislation. I'm arguing for a broader teacher quality
package that will allow the people on the scene to make those
decisions.
Senator Murray. Well, I agree. Teacher quality is
important, too, but so is class size.
And before I yield my time, I just want to ask you a
question about the chart that you have here, because you show
that between 1984 and 2002, the increase in funding has gone up
significantly and the red line representing NAEP reading
scores, age nine, has been level.
But is it not true that since 1984, when we had a little
over 39 million students, our public schools have grown to
serve 47 million students? And that chart is a little bit
misleading, because we are actually educating a lot more kids
in our public schools than we were in 1984. And those demands
on the school system are not considered in that chart.
Secretary Paige. Yes.
Senator Murray. I just wanted to make that clear.
Secretary Paige. You are correct. That is correct. What
that says is our challenge is broader, our task is more
difficult, but the----
Senator Murray. Sure.
Secretary Paige [continuing]. But the scores are still
flat.
Senator Murray. But you cannot say that we have increased
funding and test scores have stayed the same to make the
correlation that individual students are getting more money,
because we are clearly educating more students in our schools.
I understand my time is up. And I would yield back to the
Chair.
Secretary Paige. Yes.
Senator Specter. Thank you very much, Senator Murray. We
are sticking very close to the time. There is a Judiciary
Committee meeting. And I have just been informed that they have
nine Senators and need a tenth for a quorum.
So, we are going to take Solomon's approach and split the
Senator down the center, so he can be in two places at one
time.
Let me proceed to ask you a number of questions, Mr.
Secretary, and either to have abbreviated answers, so I can
cover them rapidly, or you can put them in writing. And then I
am going to defer to Senator Harkin, who has one more question.
And then I am going to excuse myself.
Vouchers and school choice
On the question of vouchers, the President's program
provides that if certain standards are not met within a third-
year point, there will be vouchers issued.
As I understand it, in the past, you have opposed vouchers
to private schools.
Secretary Paige. Well, no, I have not.
Senator Specter. That is not so?
Secretary Paige. I have been a passionate supporter of
cooperating with private schools and had a very broad private
school program in Houston I operated for 4 years.
Senator Specter. Well, there is considerable concern in the
Congress about vouchers. As you know, they were defeated in the
House and----
Secretary Paige. I am aware of that.
Senator Specter [continuing]. My instinct is that while it
will be a close vote, it will probably not succeed. And I would
like for you to submit, in writing to the committee, because it
is a complicated subject----
Secretary Paige. Yes, it is.
Senator Specter [continuing]. And you cannot deal with it--
--
Secretary Paige. Right.
Senator Specter [continuing]. In a few minutes, your
philosophical grounding. We have great respect for your views,
because of your experience. Also, please deal with the question
which is raised so consistently about what will happen to the
public school system if vouchers do become the order of the
day. And also, to comment on the amendment to be offered by
Senator Carper, vouchers for use in public schools.
Secretary Paige. Yes, sir.
Senator Specter. The program of Youth Violence was adopted
by this subcommittee 2 years ago, really utilizing the same
philosophy that you have approached, and that is by taking
$1.45 billion from other programs and directing it to Youth
Violence. And I would appreciate it if you would take a look at
the program we have coordinated with the Department of Health,
Human Services and Labor and Department of Justice, and give us
your evaluation of that.
It is my hope to have a meeting coordinated with the
President's domestic advisor. We would be interested in your
evaluation there, and your further suggestions on how we deal
with youth violence.
We have made this proposal without any news conferences,
any public attention, but with a whole series of workshops
where Senator Harkin and I personally participated for hours on
end, bringing in the people who really know--the technicians in
the field. And we would appreciate it if you would take a look
at it----
Secretary Paige. I will.
Senator Specter [continuing]. And give us your advice.
Campus crime
Next, there is the issue of campus crime, where legislation
was enacted more than a decade ago, after a brutal rape-murder
at a Pennsylvania college, and the parents, Mr. Howard and Mrs.
Connie Clery, came forward.
Now, there has been a problem with respect to the
Department's implementation of the Clery Act. The guidance from
the Department on reporting standards has been hard to get. And
when there are violations, it is difficult to secure
investigation and corrective action. I had introduced that
legislation and later produced amendments to toughen it up.
And this is something which is very, very important; the
essence of which is to tell people what is happening on the
campus, so they know what the risks are. And that has the
therapeutic effect of colleges and universities not wanting to
report campus crime, so acting to prevent it and a great many
efforts to circumvent it by not counting the sidewalks through
the university campus as part of the university or not counting
university leased premises as part of the university.
So, we would appreciate your review and comment on that.
Secretary Paige. I thank you for that legislation, Mr.
Chairman. And I will tell you, you have my commitment that we
are going to have a strong look at this, because this is the
right thing to do. You have our support.
Budget increases to be tied to reform and results
Senator Specter. Well, I appreciate that comment. I only
want to ask you one question for the record. I wrote down what
you said, when you said, ``I think that the President is
`amenable to increasing the spending of funds.'''
By that, do you mean that if the Congress comes in somewhat
higher or a little higher or reasonably higher than the
President's budget, we might get him to sign the bill?
Secretary Paige. I meant by that, that the President
appears to me, from my interaction with him, willing to fund
reform. And dollars that are tied to making things work better,
he seems to be more willing to support.
So, the connection would be funding reform. What he objects
to is funding failure.
Senator Specter. Well----
Secretary Paige. I think he would be willing to spend
whatever amount is necessary to reform the system, assuming
those two things are connected.
Senator Specter. Well, that is a fair challenge. If we tie
our spending to reform, we may then look for the President's
concurrence.
Mr. Secretary, thank you very much for coming in.
Secretary Paige. Thank you.
Senator Specter. Again, I think we have covered the subject
matter, although we have subverted on you to respond in
writing, because of limitations of time. And I am going to turn
the gavel over to Senator Harkin, who says he has one more
subject matter. It is that hot newspaper article that he is
indifferent to that he wants to ask you about.
Thank you, Mr. Secretary.
Secretary Paige. Thank you. And thank you, Mr. Chairman,
for your leadership.
Senator Harkin. Thank you. I have actually got two
questions, but one basically that covers----
Senator Specter. You can answer only one of them. You take
your source. He said he only had one question.
Senator Harkin. Then I will adjourn it, Mr. Chairman.
Senator Specter. Thank you.
Senator Harkin [presiding]. Mr. Secretary, again, back to
the construction thing. Again, it is my understanding that your
department has written a new guidance, alerting States that
they might be able to spend school renovation grants in a way
that Congress did not intend.
Under current law, 75 percent of this money had to be used
for school renovation; 25 percent could be, if they wanted to,
used for IDEA, Individual Disabilities--doing things that meet
their needs for special education and technology for special
education.
I am understanding that your new guidance is telling the
States they do not have to do this, because Congress might
eliminate the fund. First of all, what is the status of this
guidance?
Secretary Paige. Mr. Chairman, let me find out more about
that. I am not equipped to answer that question, but I promise
this----
Senator Harkin. Yes.
Secretary Paige [continuing]. Administration supports
administering it so that congressional intent is carried out.
So, I will look into it and get right back to you on that one.
Senator Harkin. I would like to know that, because I just
heard this, and I was just going to urge you to not issue this
guidance, because----
Mr. Skelly. Well, Senator Harkin, we have not issued the
guidance, yet. We have drafted it. And we shared the content of
the guidance with some of the staff on your committee just to
see what they would think about it.
President's proposal and use of school construction funds
What it says is that although the current law does allow
States considerable flexibility in using money for IDEA or
technology, in addition to school renovation, the President's
budget has made a proposal that would allow them even more
flexibility to use that; not just 25 percent, but maybe 50 or
100 percent for special education or technology, if they chose
to do that.
It is a proposal that was in the President's budget. The
Congress would have to accept that proposal, pass it, and the
President would have to sign it into law for that to take
effect. And the guidance merely reiterates that the President's
budget made that proposal.
Senator Harkin. I understand what you are saying is that
you would take the 2001 money, the money we already
appropriated, and change how they could spend it, but you
cannot do that on your own. You have to get us to do that.
Mr. Skelly. That is exactly right. The guidance says----
Senator Harkin. Well, I can tell you right now, forget it.
Mr. Skelly. All right.
Senator Harkin. Forget it. It is not going to happen. I
cannot speak for the Chairman, but I think I can on this one.
Forget it.
Mr. Skelly. Okay.
Senator Harkin. Because what that would do, I think, would
create a lot of turmoil out there. We will fight the other
battles next year and beyond, but on this one, I think it might
confuse a lot of school districts out there and say, ``Well, we
want to apply for the money. Why apply for it, if we cannot use
it and they are going to change it?''
As long as it is there, the money is--goes out July 1st.
School districts, I know, all over the country, are thinking
about applying for this. There are State Departments of
Education. I do not think it would be fair to confuse them on
it at this point.
Funding for special education and idea reauthorization
But what I really wanted to ask--now I am going to run out
of time here--is that the administration indicated it was
particularly upset by a vote last week to increase funding for
schooling disabled students and lock it into the Federal budget
for the next 10 years by shielding it from the annual
appropriations process, which is exactly what we did.
We put it on the mandatory side. It had broad-based
bipartisan support. Senator Hagel was my co-sponsor on it;
Senator Jeffords, Senator Specter. I mean, broad. It passed by
unanimous consent and no one objected to it. And officials
described the proposal as costly and unwarranted.
Can you please respond to that, because this is very, very
disturbing?
Secretary Paige. Well, Senator, I have not read that. This
is the first time I have heard that language. I do not have
anything to add to what is written there, because I have not
ever seen the article.
Senator Harkin. Okay. So, it did not come out of your shop,
then.
Secretary Paige. I do not know.
Mr. Skelly. That is from the Statement of Administration
Policy, which is issued by the Office of Management and Budget.
It was part of a longer piece. And it mentioned the IDEA
amendment.
Senator Harkin. Is that a correct quote, then, from it;
that it is costly and unwarranted?
Mr. Skelly. Those are adjectives used in the statement,
yes.
Senator Harkin. By OMB. That meeting our 40 percent
obligation was costly and unwarranted.
Mr. Skelly. I think the argument is that the--making it
mandatory at this time, as a floor amendment to the ESEA,
without a longer review of the IDEA--the IDEA, you know, was
reauthorized in 1997. It will come up again in another 18
months.
It would be good to have a more thorough review of the
IDEA, I think, is what the administration's position is, rather
than making a change now as part of a floor amendment on ESEA.
Senator Harkin. Well, okay. I can accept that as an
argument. I just would point out that we are not changing any
of the underlying law in IDEA. We are not--we are not changing
it. We just simply are appropriating money to meet the
underlying 40 percent requirement. That is all.
I do not--I cannot see any--any indication out there at all
that we want to reduce that 40 percent. I think that would run
into a firestorm around here.
Mr. Skelly. I think there is one other change in the basic
law that would change the fiscal relief provision from 20
percent, which was enacted in 1997, to 55 percent. In other
words, of the additional funds that are made available for
IDEA, Part B, State grants, some of the--if States are
providing services to children with disabilities already, they
could use some of that money for fiscal relief, use it for
other purposes. So----
Senator Harkin. But we can do that when we reauthorize
IDEA. What we did, putting it on the mandatory side, has no
effect on that. I mean, we can--we can do that. If that is the
will of the Congress and the administration to do that, we can
do that at that time.
Mr. Skelly. It was in--it was just in the same amendment.
Senator Harkin. Well, I understand, but--but I do not--
reauthorizing IDEA does not have anything to do with the
funding. We are just funding it. If we want to change the mix
and stuff, we can do that any time we want on the
reauthorization end of it, 2 years from now.
But I just think--the choice of words as being costly and
unwarranted, I think, is a poor choice of words from OMB on
that. And I hope that there might be some clarification put out
from the administration on this.
Mr. Secretary, do you have anything else to add before I--
--
Secretary Paige. I would just like to thank you for the
opportunity to come and for the stimulating discussion about
that. And although we have some differences in point of view, I
have great respect for your interests in improving education in
America.
Testing and accountability
Senator Harkin. Well, we will work together on this. I know
that there are a lot of things we have got to do together. See,
I want to--just for the record, make it clear, I am not opposed
to what you are trying to do, in terms of testing and
accountability and to try to model what you did in the Houston
school system. I have no problem with that.
Cost of annual testing
I think there has got to be a broader approach and other
things that we have got to do beyond that. And fine. I can
support your proposals on that, but funding, I guess, maybe we
look at it, as appropriators--the National State Boards of
Education estimated that all this additional testing would cost
$2.7 to $7 billion extra. Now, I cannot verify that. That is
what I heard from the State Boards of Education.
Well, if we are going to require them to test, we ought to
help them with some of the funding, too. I mean, I do not know
if that is a proper amount of money or not. But somehow we are
going to have to think about getting some additional funds out
there for helping them with this testing and stuff.
Secretary Paige. May I just make one observation about
that, Mr. Chairman? The President is proposing $320 million to
help States with the development of tests. The actual
implementation of tests, the cost of that varies with the
effectiveness of the management of the various test
implementors.
In Houston, it cost--we had to spend--for nine administered
grades, 1 through 11, we implemented that at the cost of about
$10 per child. And that was because it was very finely managed
and carefully controlled. That cost could vary from what I
think to be our very effective cost of $10 per child to $50 a
child. It would depend on the effectiveness of the organization
and how much the people who administer it want to save dollars
there.
So, it is a figure that we really cannot get our arms
around. And besides, the 1994 reauthorization required
administering tests to all the students at least three times
through the pipeline. And there was no argument, then, about
paying for those tests that they imposed on school districts at
that time.
So, what we are talking about is simply just adding tests,
but we do see a need to help with the development of these
tests. We know that this is going to be a process, not an
event. And we will grow, in terms of learning about the costs.
Closing remarks
Senator Harkin. Fair enough. Well, thank you very much, Mr.
Secretary----
Secretary Paige. Thank you.
Senator Harkin [continuing]. For your dedication to
education. I am sure we will have an opportunity to meet
repeatedly, between now and whenever we get our budget through
and our appropriations bills through, to work out our problems
on this.
Secretary Paige. Thank you, Senator.
Additional committee questions
Senator Harkin. 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
private school vouchers
Question. Please provide your philosophical grounding for your
support of vouchers and explain what you think happens to the public
school system. Also, please provide your view of Senator Carper's bill
and its impact on the public school system.
Answer. In the broadest sense, we believe that just as market-based
competition works throughout our economy to maximize the efficient use
of resources and provide high-quality goods and services at low cost,
greater competition is good for our system of public education. This is
why, for example, the President is such a strong supporter of charter
schools, which encourage innovation that not only leads to better
options for parents and students, but also brings pressure on regular
public schools to improve their own educational offerings.
We also support the limited use of vouchers because we believe that
parents and students alike benefit greatly from the ability to choose
the school that best meets their educational needs. And when parents
choose the school their child attends, they are more likely to actively
support the school. I can tell you from personal experience that when
parents get involved in our schools, good things happen.
More specifically, it cannot be denied that there are too many
schools that are failing our children, denying them the opportunity to
reach their full potential as citizens and human beings. Vouchers and
other forms of choice can help ensure that no child is trapped in a
failing school--one of the central goals of No Child Left Behind.
As for the impact of vouchers on our public schools, I have two
answers. One is that for the foreseeable future the vast majority of
our children will continue to attend public schools, even if in limited
circumstances vouchers are available. In my view, vouchers present very
little in the way of a threat to our long tradition of public
education. In large part this is because of my second answer, which is
that in general public schools compete very well with private schools.
This was my experience in Houston, and I believe it would be the
experience nationwide if voucher systems were more widely adopted.
amendment proposed by senator thomas r. carper
Senator Carper's proposed amendment would authorize competitive
grants to States or school districts to support the implementation of
universal public school choice programs. As you know, President Bush
and I support the expansion of choice and educational options for
parents and students, and I believe Senator Carper's proposal would be
a step in the right direction in this area. In particular, the Carper
proposal would support the creation of meaningful choice by helping to
pay for the cost of transporting students to the schools they choose to
attend, and by helping to expand capacity at the high-quality, high-
demand schools that students will want to attend.
youth violence
Question. Please look at the programs included in the youth
violence prevention initiative that we have coordinated with other
agencies and evaluate what has been done and provide further
suggestions on how to deal with the issue of youth violence.
Answer. A number of the programs included in this initiative are
demonstrating an impact on fostering youth violence prevention
activities in communities across the country. For example, the Safe
Schools/Healthy Students initiative the Department of Education has
funded jointly with the Departments of Justice and Health and Human
Services is supporting collaborations between schools, mental health
providers, and law enforcement that promote healthy child and youth
development and safer schools. In fiscal year 2000, some Safe Schools/
Healthy Students communities reported decreases in arrests and
detentions for violent acts at school. They also reported increases in
the provision of mental health assessment and treatment services to
students.
The Department's 21st Century Community Learning Centers program is
helping to provide safe and stimulating after-school environments for
students in supervised settings in which they can receive homework
support, mentoring, drug and violence prevention counseling, and
college preparation services. One grantee has reported a 40 percent
drop in juvenile crime in the neighborhood surrounding the Learning
Center's after-school program. Another has reported that the program
led to a substantial drop in student use of drugs, alcohol, and
tobacco.
Several States are reporting that their Character Education
programs are having a positive influence on student behavior. For
example, an independent evaluation of the first year of Maryland's
program found that students were perceived to be more likely to solve
conflicts without fighting, insults or threats; to respect others'
personal rights; and to treat classmates with respect. In Utah,
participating schools reported a decrease in discipline referrals,
fewer student fights and confrontations, decreased vandalism, less
tardiness, and an increase in positive behaviors such as interacting
more kindly and respectfully with students and teachers, better
attendance, improved achievement, and greater student involvement in
extracurricular activities.
One of the strongest suggestions I can offer for addressing the
problem of youth violence is to hold schools accountable for school
safety. That is why the Administration's No Child Left Behind proposal
would require States to develop a definition for a ``persistently
dangerous school'' and to provide victims of serious, schoolbased
crimes and students trapped in persistently dangerous schools the
option to transfer to a safe alternative.
clery act implementation
Question. I have some concerns about the Department of Education's
implementation of the Clery Act. Please review and comment on the
implementation of this Act.
Answer. The Department has made a good faith effort to implement
the Clery Act. Last year, for example, the Department collected crime
statistics as required by the Act. In collecting these statistics, the
Department used a web-based data collection tool through which
statistics were publicly available as the data were collected. This
approach--combined with the Department's aggressive enforcement of the
requirement--resulted in a 100 percent response rate to this data
collection.
In addition to collecting the campus crime statistics, the
Department has successfully investigated allegations that institutions
were misrepresenting their crime statistics. Generally, we have been
successful in bringing institutions into compliance with the
requirements of the Act. When appropriate, the Department has imposed
fines for non-compliance.
education funds for reform
Question. You stated during your oral remarks that you believe the
President would be ``amenable to increased funding.'' Please elaborate
on this remark.
Answer. As I said earlier, the question is really not about
funding, but reform. I believe the President is willing to fund serious
reform efforts, such as those proposed in No Child Left Behind and
included in our 2002 budget request. He is not willing to continue
funding failure in our education system.
school renovation grants--guidance for implementation
Question. What is the status of the Department's guidance for
implementation of the School Renovation grants program enacted in the
fiscal year 2001 Labor-HHS Education appropriations conference report?
Answer. The Department distributed guidance for the School
Renovation grants program to State coordinators on May 17, 2001.
Question. What statutes, rules or regulations (internal Department
or government-wide) govern when and how the guidance may be issued?
Answer. The School Renovation program guidance is non-regulatory.
Nonregulatory guidance is not subject to the Administrative Procedures
Act, as is the case with regulations. Furthermore, other statutes or
regulations do not generally govern the issuance of guidance.
The guidance for the school renovation program is designed to
explain, using plain language, the provisions of the legislation to
help grant recipients understand the requirements in the legislation.
The Department conducts an internal review of guidance to ensure
consistency with legislation before it is issued.
Question. Will the guidance package be wholly consistent with
congressional intent as expressed in the fiscal year 2001 Act, and will
the purpose of the program be reflected throughout the document
(including cover notes, supplemental material, guidance, etc.)?
Answer. Yes, the guidance package is wholly consistent with the
congressional intent expressed in the Fiscal Year 2001 Department of
Education Appropriations Act.
As you know, the Administration's 2002 budget submission proposed
to amend the 2001 appropriations act to provide States with additional
flexibility in how they may spend their portion of the $1.2 billion in
fiscal year 2001 school renovation funds. The Administration proposes
to allow States to choose how much of the funds may be spent on any of
the three currently allowable activities: school renovation, activities
under Part B of the IDEA, and technology activities associated with
school renovation.
If Congress enacted the Administration's proposal, we would
communicate the enactment to the States. The Administration remains
committed to securing this flexibility for the States whether
congressional action occurs before or after July 1 of this year.
21st century community learning centers
Question. The budget request proposes to consolidate the 21st
Century Community Learning Centers and Safe and Drug-Free Schools
programs in a formula driven State grant program so that school
districts can support drug and violence prevention activities as well
as after school activities. How will this help improve student safety
given the findings in the Department's ``Progress in Prevention''
national evaluation of the Safe and Drug Free Schools program that 46
percent of districts would lose their prevention programming without
its funding and more than 75 percent would reduce them to a great
extent?
Answer. The Administration's fiscal year 2002 budget request does
not propose to consolidate the 21st Century Community Learning Centers
and Safe and Drug-Free Schools programs into a single formula grant
program. The request would maintain separate funding streams for the
two programs.
The Administration is requesting $644 million in fiscal year 2002,
the same as 2001, for the Safe and Drug-Free Schools program. However,
a greater proportion of total funds would flow to States under the
President's proposal (as compared to the 2001 funding level for State
Grants) to help ensure that children receive a high-quality education
in a safe and drug-free environment. The President's No Child Left
Behind proposal for reform of elementary and secondary education would
hold States accountable for school safety by requiring States, as a
condition of receiving a performance-based grant for safe and drug-free
schools, to: (1) develop a definition for a ``persistently dangerous
school'' and to report on school safety on a school-by-school basis;
(2) provide victims of serious, school-based crimes and students
trapped in persistently dangerous schools the option to transfer to a
safe alternative; and (3) adopt a ``zero-tolerance'' policy that
empowers teachers to remove violent or persistently disruptive students
from the classroom.
The Administration is also requesting $845.6 million, the same as
fiscal year 2001, for the 21st Century Community Learning Centers
program. Program funds would be used to provide students, particularly
students who attend high-poverty or low performing schools, with high-
quality extended learning opportunities to help them meet challenging
academic standards.
unmet need and access to higher education
Question. ``Access Denied'', a report of the Advisory Committee on
Student Financial Assistance was released in February 2001 and
identified three interrelated factors that conspired to produce what is
fast becoming an access crisis. The first is the increasing cost of
higher education as a relative percentage of family income only for
low-income families and the shifting focus of Federal, State, and
institutional policies toward merit-based programs. Second, is the
steep rise in unmet need of low-income students. On average, the very
lowest income students face $3,200 of unmet need at 2-year public
institutions and $3,800 at 4-year public institutions, even after
factoring in loans. Third, students, motivated by rational financial
considerations, make choices that lower the probability of their
persistence and degree completion significantly. In addition, dramatic
demographic changes will produce an increase in college enrollment of
18 to 24 year olds of 1.6 million by 2015.
Last year's final appropriation included resources to increase the
maximum Pell Grant by $450. How does this budget reduce the opportunity
barrier of unmet need and increase access to postsecondary education
for low-income students?
Answer. The fiscal year 2002 President's Budget includes a three-
pronged approach to enhancing access to postsecondary education among
low-income students, which provides: (1) $1 billion in additional Pell
Grant funding, increasing the maximum grant to a record $3,850 (under
this proposal, the maximum grant will have grown by nearly 43 percent
over the five years through 2002, significantly faster than tuition and
fee increases over the same period); (2) continued support for
supplemental grant assistance under the TRIO Student Support Services
program, as well as increased funding for TRIO academic support and
counseling services to low-income students to better prepare them for
higher education; and, (3) additional funds to strengthen institutions
that serve large numbers of minority and low-income students, including
Historically Black Colleges and Universities and Historically Black
Graduate Schools, and for Hispanic Serving Institutions.
persistence in college
Question. What does this budget propose to increase persistence for
students saddled with high levels of debt and significant work
responsibilities while attending school on a full- or part-time basis?
Answer. Research on the relationship between persistence and work
and persistence and debt on several occasions has yielded mixed
results. Many analysts believe that the decision to depart from
postsecondary education is related to a student's specific short- and
long-term plans, the strength of the student's desire to finish, and
the difficulties associated with adapting to the challenges of college
life. In this area, the Department's budget includes increased
assistance to institutions of higher education that serve large
populations of low-income and minority students to help them meet the
needs of their students, as well as to programs that directly respond
to the needs of low-income and first-generation college students. For
example, the budget includes additional support for Historically Black
Colleges and Universities (HBCUs) under Title III and Hispanic-Serving
Institutions (HSIs) under Title V to help these institutions meet the
growing demand for their services. The budget also includes an increase
for the TRIO programs, which help to prepare low-income students for
college and help improve retention and success rates among these
students once they enter college.
growth in college population
Question. How is the Administration planning to support the
increasingly diverse needs of the additional 1.6 million college
students expected by 2015?
Answer. The fiscal year 2002 budget proposal addresses the short-
term needs for funding for postsecondary education. The
Administration's long-term strategy for supporting the diverse needs of
students enrolled in postsecondary education will be developed as we
prepare for the reauthorization of the Higher Education Act in 2003.
______
Question Submitted by Senator Larry E. Craig
trio programs
Question. Mr. Secretary, in my State, I know that TRIO's Upward
Bound and Talent Search programs have been very successful in serving
middle and high school students. These programs are enabling students
attending under-performing schools to raise their aspirations and
develop the skills to achieve those goals. How are you including TRIO
in your Department's overall plan to meet the educational needs of all
children?
Answer. TRIO plays an important role in our overall plan by
ensuring that the needs of students are met all the way through
college. In particular, the Upward Bound and Talent Search programs
target disadvantaged middle and high school students, providing
tutoring, mentoring, counseling, and other services to adequately
prepare them for success in college. The Student Support Services
program provides similar services once these students are in college,
helping them to achieve their higher education goals. The $50 million
increase requested for the TRIO programs would significantly expand
these services and increase the number of students who would benefit.
______
Questions Submitted by Senator Tom Harkin
access to a college education
Question. The President's budget would increase the maximum award
for Pell Grants by just $100, to $3,850. That's $355 less, in real
dollars, than 25 years ago. In the meantime, college tuition costs have
skyrocketed. If we really want to leave no child behind, shouldn't we
do more to help our poorest high school graduates get a college
education?
Answer. To help the poorest students and families pay the rising
cost of attending college, the Administration is proposing an
additional $1 billion in Pell Grants to increase the Pell Grant maximum
award to $3,850, the highest award ever. Under this proposal, the
maximum grant will have grown by nearly 43 percent over the five years
through 2002, significantly faster than tuition and fee increases over
the same period. The Pell Grant program is the foundation of the
Federal student assistance effort and is designed to help low- and
middle-income students attend college.
Helping the poorest high school graduates get a college education
requires more than just providing financial assistance, however, since
a disproportionate number of low-income and minority students who do
enter college do so without the academic preparation needed for
success. The Administration's budget would increase support for the
Federal TRIO programs to help prepare low-income and minority students
for postsecondary education. In addition, the Administration is
proposing to increase assistance to institutions of higher education
that serve large populations of low-income and minority students to
help them meet the needs of these students.
elementary school counseling demonstration program
Question. Most people agree that school mental health and
prevention services are critical to creating a healthy and safe
learning environment. But the President's budget would eliminate $30
million for the Elementary School Counseling Demonstration Program,
which provides assistance for hiring school counselors, school social
workers, and school psychologists. Why does the President oppose this
program?
Answer. Neither the President nor I oppose the provision of
counseling and mental health services for students; we just oppose the
proliferation of small, categorical Federal programs with narrow
purposes that limit State and local flexibility to address State and
local needs. Under the President's 2002 budget request, funding for the
Elementary School Counseling Demonstration program is consolidated
under the $471.5 million proposed Choice and Innovation State Grants
program. School districts would be permitted to use funds under this
flexible grant program to hire school counselors, social workers, and
psychologists if they choose. School districts may also use their Safe
and Drug-Free Schools and Communities State (SDFSC) Grant funds to
provide counseling and related services for students. The President's
2002 budget request includes $547.3 million for SDFSC State Grants, a
$108 million increase over 2001.
special education teacher shortages
Question. There is a tremendous shortage of special education
personnel throughout the country--second only to math/science.
Currently there are over 35,000 individuals teaching students with
disabilities who are not qualified to do so. The Department of Labor
estimates that schools will need more than 200,000 new special
education teachers over the next five years. Yet our colleges and
universities prepare only half that number. We are even beginning to
document increasing shortages of special education faculty in our
Nation's universities.
In addition, with new programs, such as the President's Reading
First and Early Reading First, there will be even a greater need for
special education professionals with skills in communications disorders
and early literacy interventions. The President's budget calls for
level funding for Personnel Preparation for the Individuals with
Disabilities Education Act (IDEA). This account has not received an
increase in over a decade despite these critical shortages. We are
working hard to fully fund Part B of IDEA, but without qualified
teachers, we will not get the results we want. What is your plan to
address these critical personnel shortages, and why didn't you request
an increase in funding for Personnel Preparation?
Answer. We believe that if large increases in funding are provided
over a short period of time for the Grants to States program under Part
B of IDEA, they may not be used to achieve the improved results we all
want for children with disabilities. For example, with large increases
local educational agencies may have more resources to hire special
education teachers, but may be unable to do so because the supply of
such teachers is relatively inelastic in the short term.
However, more gradual increases, such as the $1 billion increase
proposed in the President's budget, may be used effectively to promote
improved working conditions, smaller class sizes, retention incentives,
inservice training, and other activities as well as increased salaries
that will create greater incentives for college students to enter and
remain in the field of special education. We believe that the best way
to recruit and retain special education personnel is through enhancing
the value of working in that field and not necessarily through
providing additional funds to institutions of higher education, which
is the primary activity under the Special Education Personnel
Preparation program.
In addition to the funds requested for the Grants to States
program, funds to address personnel needs are also provided through the
Special Education State Improvement program, which was authorized by
the IDEA Amendments of 1997. This program awards grants to States to
help them to address their particular needs. States must use at least
75 percent of their grants under this program to address their special
education personnel needs. Our fiscal year 2002 request for this
program is $49.2 million, and there was a $14 million increase in
funding for the program in fiscal year 2001.
We believe that the combination of increased funding provided for
the Grants to States program, support for the new State Improvement
program, and maintenance of support for the Personnel Preparation
program will begin to effectively address our needs for special
education personnel.
math and science budget support
Question. The President's budget calls for tripling the spending on
reading to improve instruction and student achievement in the early
grades. His education reform plan would require annual testing in
reading and mathematics. Given that teacher shortages put math and
science at the top of the list, why is a similar investment in the
preparation and professional development of teachers in those key
fields not similarly recommended in the budget for the Department of
Education?
Answer. No Child Left Behind reflects the President's commitment to
improving the quality of our teaching force in all subject areas,
including mathematics and science, because teacher excellence is vital
to achieving improvement in student achievement. The Administration's
fiscal year 2002 budget request reflects this commitment because it
includes $2.6 billion for the Department of Education for the State
Grants for Improving Teacher Quality program and $200 million for the
National Science Foundation for the Math-Science Partnership program.
The State Grants for Improving Teacher Quality program would
combine funding from several existing education programs, including
Class Size Reduction and Eisenhower Professional Development State
Grants, into performance-based grants that provide sufficient
flexibility for States and local educational agencies (LEAs) to meet
their particular needs and to strengthen the skills and improve the
knowledge of teachers and administrators. Because of the flexibility
that the President is proposing for this program, States and LEAs would
be able to use program funds to improve the quality of their
mathematics and science teaching force, if they believe that would best
address their needs.
In return for this flexibility, States and LEAs would be required
to ensure that program funds are used for professional development that
is grounded in scientifically based research. States would be held
accountable for ensuring that all children are taught by effective
teachers and improving student academic achievement. Professional
development programs also would be tied to State or local standards, of
sufficient intensity and duration to affect teaching performance, and
directly related to the subjects taught by the teachers who are
participating in the professional development.
In addition, the Math-Science Partnership program, which the
President is proposing as a National Science Foundation program, would
provide funds for States to join with institutions of higher education
to strengthen mathematics and science K-12 education. These
partnerships, which could also include LEAs, would provide highquality
teacher preparation and professional development for mathematics and
science teachers, help to implement high standards in mathematics and
science education, and address gaps between the education of advantaged
and disadvantaged students.
assistive technology act, title i state grants program
Question. The State Grants program under Title I of the Assistive
Technology Act is slated to sunset beginning this year. And the
President's budget calls for an increase of $25 million for the Title
III Assistive Technology Loan program. To date, all of the grants that
have been awarded under Title III have been awarded to the Title I
State projects. Who will run these loan programs if the Title I
projects sunset?
Answer. Under Title III of the Assistive Technology (AT) Act, the
Secretary is authorized to make grants to States for the administration
of alternative financing programs. In order for a State to be eligible
for funding under the Title III Alternative Financing Program, the
State must receive or have received Title I funding. Therefore, the AT
Act clearly contemplates that when States apply for Title III funds
they may no longer be participating in the Title I program. In
addition, the State is required to enter into a contract with an
experienced community-based organization to administer the Alternative
Financing Program.
gaann and javits fellowships
Question. The Department proposes level funding of the Graduate
Assistance in Areas of National Need (GAANN) and Jacob Javits program
at $31 million and $10 million, respectively. These programs support
graduate students who will become the teachers, scholars and
researchers of tomorrow. Since the stipend level for these two programs
is tied by statute to the stipend level for the Graduate Research
Fellowship program at the National Science Foundation (NSF), the
stipend for both these programs will increase to $18,000 per student in
the 2001-2002 academic year and to $20,500 in 2002-2003. Because of
this, the number of new fellowships in the Javits program will decrease
significantly and there will be no resources available for a GAANN
competition or new awards this coming year. Knowing that an increase in
funding, to keep pace with statutory obligations to increase stipends,
was the only way program integrity could remain intact, why did the
Administration decide to level-fund both programs?
Answer. At the time we submitted our fiscal year 2002 budget
request, the approved NSF stipend level was $18,000. Unfortunately, we
had no way of knowing that it would be increased for the second time in
two years to $20,500 for the 2002-2003 academic year. However, knowing
that it is difficult to predict the average fellow's level of need and
the maximum stipend level that will be in effect at the time we make
awards, our estimates were based on all fellows receiving the maximum
stipend that was in effect at the time we submitted the budget. As
such, our estimates reflect the minimum number of fellows that would
have been supported with a maximum stipend of $18,000.
Under the Administration's request for the Javits Fellowships
program, even with a stipend level of $20,500, a minimum of 60 new
fellows would be supported in fiscal year 2002. The request for GAANN,
even though it would not support a new competition, would maintain
support for approximately 1,070 continuing fellows. A new competition
would be held again in fiscal year 2003.
Question. What will the Administration do in the future to support
these two small, yet vitally important programs in graduate education?
Answer. The Administration will continue to work to ensure that all
low-income students have the resources necessary to complete their
postsecondary education. The Javits Fellowships and GAANN programs play
an important role in preparing students for scholarly careers and
careers in areas of national need, which will remain a critical part of
our goal to strengthen America's workforce.
vocational education programs support
Question. Career technical education funding has declined 19
percent, in real dollars, in the past decade. At a time when the Labor
Department is reporting increasing unemployment, why has President Bush
level funded and, in some cases, cut programs in the Carl D. Perkins
Vocational Technical Education Act, a law whose sole purpose is to
prepare America's students with the skills, education and training they
will need to pursue employment or higher education? Please address the
proposed level funding of Basic State Grants, the cut to National
Programs, and the elimination of the Tech Prep Demonstration Program.
Answer. The Department's 2002 budget received the largest
percentage increase of any Cabinet-level domestic agency. The budget
reflects major increases for the Administration's highest priority
areas, including $1 billion for Special Education Grants to States, $1
billion for Pell Grants, and substantial new funding to implement
changes proposed in No Child Left Behind, the President's framework for
reauthorization of the Elementary and Secondary Education Act. Under
the proposal, many programs are eliminated or consolidated, but none of
the consolidations affect the Vocational Education appropriation. The
Administration recognizes the importance of the Vocational Education
State Grants by maintaining level funding for the program.
The fiscal year 2002 request includes $12 million for National
Programs, a reduction of $5.5 million. In past years, National Programs
provided funds to assist in the implementation of new accountability
requirements and other provisions of the 1998 reauthorization. Now the
implementation is well underway, and many national activities have
been, or will be, completed by fiscal year 2002. The request provides
sufficient funding to support major national initiatives.
The Administration requests zero funding for the Tech-Prep
demonstration program, which is consistent with the effort to redirect
resources to high-priority areas and to eliminate small programs whose
activities can be funded from other sources. Currently, States can use
funds they receive from the Tech-Prep State grant program to support
this kind of activity. In fact, some States are already developing and
implementing Tech-Prep programs that locate secondary schools on
community college campuses and that can be disseminated and adopted by
other States. The Department does not believe that a separate, more
prescriptively structured, program that specifically focuses on this
area is needed.
______
Question Submitted by Senator Harry Reid
addressing the dropout problem
Question. Secretary Paige, how do you plan to address the dropout
problem our nation faces? Please provide the specific, measurable steps
you plan to implement to address the problem.
Answer. Research has shown that poor academic performance is the
best predictor of who will drop out of school. Students who receive low
grades, perform poorly on tests, are retained in grade, or are absent
frequently are more likely to drop out before completing high school
than are their peers. No Child Left Behind, the President's framework
for reforming elementary and secondary education, would apply proven
strategies--high State standards, annual testing of students in grades
three through eight in at least reading and mathematics, increased
accountability for student performance, reduced bureaucracy and greater
flexibility for States, school districts, and schools, and expanded
options for parents to make choices for their children's education--to
strengthen Federal support for State and local efforts to help improve
student achievement.
The most effective strategy for preventing students from dropping
out is to ensure that they are successful and engaged at school. The
strategies proposed by the President would help ensure that all
students have the opportunity to succeed in school. For example,
research has shown that early intervention for students who show signs
of academic difficulty or disengagement from school is very important.
The President's proposal for annual testing of students in at least
reading and mathematics would provide teachers with current information
on a child's progress in school, including specific strengths and
weaknesses, and enable teachers to arrange for the types of support and
remediation that are most likely to help that child succeed
academically.
In addition, research shows that students who fail to read well by
the fourth grade have a greater likelihood of dropping out and a
lifetime of diminished success. The Administration's proposed Reading
First State Grants and Early Reading First programs will help States
and school districts implement comprehensive reading instruction,
grounded in scientifically based reading research, to enhance the pre-
reading skills and school readiness of school-aged children and to
ensure that all children can read well by the end of third grade.
______
Questions Submitted by Senator Mary Landrieu
title i budget request
Question. Like you, I strongly believe that the targeted
investments we make through Title I Grants are key if we hope to turn
around low performing schools, improve teacher quality and ensure that
all students achieve high standards. Although I am extremely pleased by
the fact that all of the excess dollars included under this section are
to be allocated through the targeted grants formula, I still have grave
concerns about how little the President's budget invests in increasing
Title I.
In my own State of Louisiana last year, their overall Title I
allocation was reduced by $16 million because of insufficient funds at
the Federal level. This year's increase, even if targeted, would bring
only $2 million in new money for these purposes. This is in a State
where over 20 percent of the school age kids are in poverty. As a
Superintendent, you know accountability and reform cost money. Do you
honestly believe that this amount is sufficient to help achieve the
goals the President has laid out?
Answer. I agree that resources are important, but my experience as
Superintendent showed that how money is spent can be just as important
as how much is available, and that improving management and
accountability allow more funds to be used for the instruction of
students. In any case, the President's budget does include $400
million, an increase of $175 million or 78 percent, to support State
and local efforts to turn around low-performing Title I schools. Your
State of Louisiana will share in these funds in proportion to its
overall Title I allocation.
I must point out, however, that Louisiana received a lower Title I
allocation last year not because of insufficient funding--the Title I
appropriation rose $660 million or more than 8 percent from 2000 to
2001--but because its child poverty rate has been declining in recent
years. It is certainly true that Louisiana remains a poor State, but
according to Census estimates its percentage of school-age kids in
poverty fell from almost 29 percent in 1995 to a little over 24 percent
in 1997. Other States experienced growing poverty rates over the same
period. The Title I funding formulas are designed to target funds to
States and school districts that have a growing population of poor
children, so this shift in poverty rates resulted in lower allocations
for Louisiana and other States with declining relative shares of poor
children, and higher allocations for States with rising proportions of
poor children.
transition to teaching
Question. I am glad to see that the budget includes additional
resources to address the teacher shortage. I am particularly interested
in two of the programs you include. First, the Transition to Teaching
program. Currently, this money is used to support the Troops to
Teachers Program, which is a wonderful program. I understand that this
budget gives you the authority to expand on that program to recruit
other mid-career professionals. Can you tell me what efforts you hope
to include?
Answer. For fiscal year 2002, the President is requesting $30
million for a Transition to Teaching initiative. In addition to funding
the Troops to Teachers program under this initiative, the Secretary
would have the authority to reserve some of these funds for a program
that would be similar to the Transition to Teaching program for which
Congress appropriated $31 million in fiscal year 2001. Funds could
support efforts to recruit, prepare, and support a wide range of
talented career-changing professionals as teachers, particularly in
high-poverty schools and in high-need subject areas.
In fiscal year 2001, the appropriation for the Eisenhower National
Activities program included $3 million to be transferred to the
Department of Defense for the Troops to Teachers program and $31
million for Transition to Teaching activities to recruit and support
mid-career professionals and recent college graduates to become
teachers.
The Department has already transferred the $3 million in fiscal
year 2001 funds to the Department of Defense for the Troops to Teachers
program. With these funds, the Department of Defense will be able to
support and expand the highly effective Troops to Teachers program by
providing high-quality teachers for more students in high-poverty
schools.
Also, the Department's competition for the fiscal year 2001
Transition to Teaching program is underway; applications became
available in April and must be returned to the Department by June 15,
2001. The fiscal year 2001 Transition to Teaching program will provide
support for recent college graduates with outstanding academic records
to become licensed and successful teachers. The program would also
provide assistance for mid-career professionals with work experience in
high-need areas to become successful teachers.
teacher retention and recruitment grants
Question. I am also concerned by your decision not to increase your
efforts in the area of higher education for teachers. In my own State,
it has been the institutions of higher education that have led the
efforts to recruit and retain qualified teachers. They also are crucial
in preparing teachers for the challenges they will face. The budget
mentions that Title II Teacher Quality money is also available for
these efforts, but that money is barely enough for professional
development, recruitment and retention of existing teachers. Would you
care to comment?
Answer. The Administration's budget includes $2.6 billion to
support a new program, State Grants for Improving Teacher Quality,
which is an increase of $375 million over funding provided in fiscal
year 2001 for consolidating programs like the Class Size Reduction and
Eisenhower Professional Development State Grants. Under the President's
proposal, States may choose to use these performance-based grants for
the kinds of activities authorized under the Title II program,
including changes to teacher certification or licensure requirements,
alternative certification, tenure reform, pre-service teacher
preparation, professional development, and recruitment and retention
initiatives.
pell grant program costs
Question. In the area of higher education, this budget includes an
additional $1 billion to increase the Pell Grants by $100 to a maximum
of $3,850. Recent program data show that more students are applying for
Pell Grants, and more of those applying are eligible for these awards,
than was previously expected. Will some of this money be used to
address that issue as well, and, if so, how much of the billion will be
left for the increases in awards?
Answer. As you note, recent program data indicate that more
students are applying for Pell Grants, and more of those applying are
eligible to receive aid, than was previously forecast. This has
increased the cost of funding awards for the 2001-2002 award year by
$117 million; this additional prior-year need would be funded from the
proposed $1 billion increase. In addition, the fiscal year 2001
appropriation used $319 million in surplus funds from prior years to
fully fund the maximum award level of $3,750. In the absence of these
supplemental and surplus funds, $436 million of the proposed $1 billion
increase for fiscal year 2002 is needed to maintain the previous year's
funding level, replacing the $117 million and $319 million used in
fiscal year 2001. An additional $78 million is needed to fully fund a
$3,750 maximum award in fiscal year 2002. Increasing the maximum award
by $100, to $3,850, for academic year 2002-2003 requires $312 million,
with the remaining $57 million of the proposed $1 billion set aside to
account for possible further growth in program costs.
trio programs
Question. Mr. Secretary, there are almost 9.6 million low-income
students (from middle school to college) currently eligible for the
TRIO programs. In the next decade, demographic trends show that this
number will grow considerably as more low-income students move through
the education pipeline.
Although TRIO has a demonstrated record of success, the current
funding level only allows approximately 6 percent of the eligible
population to be served. Understanding the importance of these
programs, many members on both sides of the aisle have voiced their
support of expanding TRIO so it can serve 10 percent of those eligible.
Is this a goal you think the Administration will support?
Answer. The Administration does support an expansion of the Federal
TRIO Programs. In fact, our fiscal year 2002 budget request would
expand TRIO to serve 785,000 low-income students, approximately 8
percent of the eligible population you mention. The $50 million
increase requested for TRIO would support more than 40 new projects and
provide a greater intensity of services, high school work-study
opportunities, and college scholarships to thousands of additional
students. However, TRIO is just one of many programs in the
Administration's ``No Child Left Behind'' proposal that reach out to
low-income and minority students.
Under our budget request, Gaining Early Awareness and Readiness for
Undergraduate Programs would provide academic and support services and
scholarships to more than 1 million students in high-poverty middle and
high schools. Additionally, substantial increases would be provided for
Historically Black Colleges and Universities and Hispanic-serving
Institutions that serve thousands of minority and low-income college
students. The President's budget also includes an increase of $1.9
billion for the Department's elementary and secondary education
programs.
______
Questions Submitted by Senator Robert C. Byrd
american history instruction support
Question. President Bush has stated that he wishes to strengthen
and reform education, and he has presented Congress and the American
people with an education proposal that calls for renewed diligence in
math, science, and reading. History education, however, is ignored.
History, and specifically, American history, have become stealth
subjects, transformed and disguised under the labels ``Social Studies''
or ``Civics,'' or disregarded. Consequently, our children's knowledge
of American history is shameful. What do you intend to do to address
this question?
Answer. The 2002 budget request for education, in tandem with the
education reform proposals contained in No Child Left Behind, supports
the President's comprehensive vision for closing the achievement gap
and improving the quality of education for all children. It is clear
that Federal education policy is not accomplishing its goals, despite
the investment of more than $130 billion and the creation of hundreds
of categorical programs over the past three decades. The President
proposes to eliminate many categorical programs to give States and
communities greater flexibility to use Federal resources for their own
priorities. While the Administration's proposals do not include a
separate Federal program to improve history instruction, American
history is clearly an important part of the overall curriculum. We
believe that States and school districts are in the best position to
determine how best to improve history instruction, and our proposals
provide them with the flexibility to accomplish this improvement.
teaching american history grant program
Question. On a related subject, Congress appropriated $50 million
in fiscal year 2001 to create the Teaching American History Grant
program, a national program intended to help put the study of U.S.
history back into the classroom. Apparently, however, the
Administration intends to save millions of dollars in your Department's
budget by discontinuing all one-time projects, including the Teaching
American History Grant program. Is it true that the Administration
intends to eliminate this program despite our education system's
glaring failure to teach the history of our Nation?
Answer. The Administration's budget request supports No Child Left
Behind, the President's framework for reform of elementary and
secondary education which proposes to eliminate or consolidate many
categorical programs to give States and localities greater flexibility
to use Federal resources for their own priorities. As you are aware,
the Department is proceeding to use the $50 million Congress
appropriated in 2001 to make awards under the Teaching American History
grant program. Department staff have worked with your office, the
National Endowment for the Humanities, and a variety of organizations
dedicated to improving the teaching of American history in order to
ensure that this program is successful.
So that grantees have sufficient time and resources to implement
high-quality projects, the Teaching American History Grant program will
make awards for up to three years from the 2001 appropriation. Grants
will support programs to raise student achievement by improving
teachers' knowledge, understanding, and appreciation of American
history. They will assist local educational agencies, in partnership
with entities that have extensive content expertise, to develop,
document, evaluate and disseminate innovative, cohesive models of
professional development. These grants will offer models that can be
adopted by other communities to help improve the teaching of American
history in U.S. schools.
As noted in response to the previous question, the budget does not
include funding to continue a separate American history program, but
States and school districts would have the flexibility to use other
Federal funds to continue this type of activity.
class-size reduction funding
Question. The President proposed consolidating the Eisenhower
Professional Development program and the Class Size Reduction program
into a new teacher quality title under the Elementary and Secondary
Education Act. Accordingly, his budget provides $2.6 billion for this
new title. This would be a $375 million increase over the combined
fiscal year 2001 funding level of these programs. The Class Size
Reduction program, which has been working to reduce kindergarten
through third-grade classes nationwide from 25 to 18 students, supports
the salaries of 37,000 highly qualified new teachers. If we are to stay
on this program's schedule to hire an additional 13,000 new teachers in
fiscal year 2002, while also fulfilling our obligation to pay the
salaries of the 37,000 teachers already hired via this program, we must
provide additional funding for this program alone in the amount of $700
million. This is a shortfall of $325 million. At what level does the
President intend to meet the funding requirements of the Class Size
Reduction program?
Answer. The fiscal year 2002 budget supports the Administration's
proposal, to combine the Class Size Reduction program with the
Eisenhower Professional Development State Grants program and a few
other programs into a single, flexible State grant program that
supports State and local efforts to improve the quality of instruction.
States and districts would use their funds for such activities as high-
quality professional development, reforming teacher certification or
licensure requirements, and alternative certification of teachers and
administrators. In addition, a district that believes that reducing
class size would be the most effective strategy for improving student
achievement within the district would be free to use its funds to hire
teachers to reduce class size, but no district would be compelled to
use their Federal funds in a manner that is not appropriate for its
students and teachers.
This proposal is one of several consolidation proposals in No Child
Left Behind, the President's framework for reform of elementary and
secondary education. The President believes that schools will work best
when administrators, teachers, parents, and other interested parties,
are given the latitude and support to implement the educational reforms
that best meet their needs, and then are held accountable for producing
results. The Administration recognizes that the same strategy is not
appropriate for all communities, and that is why we are proposing to
give States and districts greater flexibility in using their Federal
resources.
Question. Does the President intend to fulfill the obligation of
this program to hire 13,000 new teachers and to support the salaries of
the 37,000 teachers previously hired via this program, or does he
intend to place the burdens of these teachers' salaries on the local
school districts, therefore, jeopardizing their continued employment
and the Federal, State, and local efforts to reduce class sizes in
grades K-3 to reasonable levels?
Answer. The Administration believes that every child in America
deserves to be taught by a high-quality teacher. The $2.6 billion
requested by the Administration in fiscal year 2002 for the State
Grants for Improving Teacher Quality program is sufficient to enable
districts to retain the teachers that were hired previously under the
Class Size Reduction program and hire additional teachers to reduce
class size if a district believes that reducing class size would be the
most effective strategy for improving student achievement.
As I stated earlier, the Administration believes that schools will
work best when administrators, teachers, parents, and other interested
parties, are given the latitude and support to implement the
educational reforms that best meet their needs, and then are held
accountable for producing results. Under the Administration's proposal
for the State Grants for Improving Teacher Quality program, Federal
funds would be available to support the research-based strategy for
improving the quality of instruction and student achievement that best
meets the needs of the district. However, no district would be
compelled to use its Federal funds in a manner that is not appropriate
for its students and teachers.
______
Questions Submitted by Senator Dianne Feinstein
title i ``shortfall''
Question. The U.S. Department of Education has concluded that the
fiscal year 2001 appropriations for Title I may fall short by about
$165 million, and that States' allocations will have to be reduced as a
result. Do you support a supplemental fiscal year 2001 appropriations
bill to cover the shortfall?
Answer. The Administration completed a budget review earlier this
year that resulted in a government-wide decision to ``live within our
means'' and oppose additional requests for funding. This is part of our
overall emphasis on supporting a more sustainable rate of increase in
domestic discretionary spending.
title i allocations--use of updated data
Question. Title I was created to target funds and provide
supplemental services to disadvantaged, poor children, and the law
requires the Department to use updated counts of poor children in an
effort to ensure that funding reflects changes in the poor student
population. Do you support funding for this program that is targeted to
poor children by using the most recent count of poor children possible?
Answer. Yes, we do support the use of biennially updated Census
poverty estimates in making allocations under the Title I Grants to
Local Educational Agencies program.
title i hold-harmless
Question. Do you oppose a Title I hold-harmless provision that
``freezes in'' funding levels to States despite changes in the poor
student population?
Answer. Yes; the President's 2002 budget request for Title I
assumes the application of statutory hold-harmless provisions and not
the 100-percent hold-harmless included in appropriations language in
recent years.
SUBCOMMITTEE RECESS
Senator Harkin. Thank you very much, that concludes the
hearing. The subcommittee will stand in recess until 9 a.m.,
Wednesday, May 23, when we will meet in room SD-138 to hear
from the Acting Director, National Institutes of Health, Dr.
Ruth L. Kirschstein.
[Whereupon, at 10:45 a.m., Thursday, May 10, the
subcommittee was recessed, to reconvene at 9 a.m., Wednesday,
May 23.]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002
----------
WEDNESDAY, MAY 23, 2001
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:04 a.m., in room SD-138, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, and Harkin.
DEPARTMENT OF HEALTH AND HUMAN SRVICES
National Institutes of Health
STATEMENT OF RUTH L. KIRSCHSTEIN, M.D., ACTING DIRECTOR
ACCOMPANIED BY:
DR. RICHARD D. KLAUSNER, DIRECTOR, NATIONAL CANCER INSTITUTE
DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG AND BLOOD
INSTITUTE
DR. AUDREY S. PENN, ACTING DIRECTOR, NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND STROKE
DR. RICHARD J. HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
DR. ALLEN M. SPIEGEL, NATIONAL INSTITUTE OF DIABETES AND
DIGESTIVE AND KIDNEY DISEASES
DR. JACK A. McLAUGHLIN, ACTING DIRECTOR, NATIONAL EYE INSTITUTE
DR. STEPHEN I. KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS
AND MUSCULOSKELETAL AND SKIN DISEASES
DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. The Appropriations Subcommittee on Labor,
Health and Human Services, and Education will now proceed. This
hearing has been advanced from 9:30 to 9:00 o'clock, because of
other conflicting hearings. We are scheduled to have nominees
for key positions in the Justice Department and also Secretary
of Treasury O'Neil will be testifying before the Foreign
Operations Subcommittee. Since the scheduling was undertaken,
we have been considering the tax bill, and there has been what
is called the Filibuster by Amendments.
We came in at 6 a.m. o'clock expecting on Monday to
complete the action on the bill fairly promptly. We had 17
votes, and adjourned shortly after midnight. Yesterday we had
27 votes, and we are scheduled to reconvene at 9:30 today, so
we will not have as much time as I would like for this
important session. We thought it important to proceed with this
hearing, because we wanted to finish our subcommittee's agency
hearings to be thorough on examining the Administrations Budget
requests
Now, last year, this subcommittee tied a record going back
to 1976, completing our work on June 30th, and we had the
conference finished on July 27th, and in an effort to get there
early when you divide up $2 trillion, it is good to be at the
head of the line. One of the key reasons that I wanted to be at
the head of the line was to keep the funding going for the
National Institutes of Health.
All of you know what Senator Harkin and I have done in the
leadership role in increasing the funding for NIH. It has been
very difficult. When we appeared before the budget committee 5
years ago and asked for an extra $1 billion, we were turned
down, so we got a sharp pencil out and established the priority
for this unit at NIH over many, many others.
So the next year we went back to the budget committee and
asked for $2 billion, since we got turned down on $1 billion.
We were turned down again and we lost many votes, but finally
this year we won by a very decisive margin. The administration
has come forward with an increase in funding in excess of $2.7
billion, but Senator Harkin and I are targeting an increase of
$3.4 billion for fiscal year 2002.
We have spent a good deal of our time on the issue of stem
cells as a potential answer to a great many of the maladies,
which all of you know. It has candidly been quite an experience
to chair this subcommittee and to have people come in who are
devastated by their illnesses or the illnesses of their family
or friends. No family in the world is untouched by the
maladies. This room has been overflowing, and we have
consistent requests from groups to publicize their own
particular problem, and to prevail on NIH to give them a larger
share.
We have had Michael J. Fox coming in on Parkinson's, and we
have had Jerry Lewis coming in on muscular dystrophy, and the
breast cancer group, and the amyotrophic lateral sclerosis
group, the Alzheimer's group and children with Juvenile
diabetes.
So we have looked to this committee really almost for
miracles. Prime Minister David Ben Gurion of Israel, said, ``If
you do not believe in miracles, you are not a realist,'' and I
believe that the potential is unlimited for what you can do.
So that is why I am committed to staying here. It is fairly
well known that I wanted to move on to another subcommittee
after battling the Congress for the budget. I thought it would
be easier to chair foreign operations and deal with the
Israeli-Palestinian conflict than with the Conference Committee
on NIH, but then, realized that people were so interested in a
continued service, so here I am.
I do not want to focus on the issue of the response to the
letters that I sent on May 4 on stem cells, but candidly, I am
very concerned about not getting the answers until yesterday.
The responses totalled some 70 pages, and we hardly had time to
digest them. I am even more concerned about what I understand
may have been rewriting of the letters. I am going to come to
that in due course, but first, I want to touch on affirmative
or substantive issues, and we welcome Dr. Kirschstein here
today, the Acting Director of the National Institutes of
Health, having served as deputy director from July, 1993, until
she took over as acting.
She had served as Director of the National Institute of
General Medical Sciences, the first woman to hold the position
at NIH. She came to NIH in 1956 as a medical officer in
clinical pathology, with a BA magna cum laude from Long Island
University, and a M.D. from Tulane University.
Let me express on a personal note to Dr. Kirschstein how
appreciative I am of your work, and your cooperation, and your
devotion to your job. So the floor is yours for up to 5
minutes.
Summary statement of Dr. Ruth L. Kirschstein
Dr. Kirschstein. Thank you, Mr. Chairman, for those very
kind words. Today, I appear before the subcommittee with my
colleagues, the directors of the NIH's 27 institutes and
centers. As you said, the President's budget for fiscal year
2002 reflects the administration's commitment to doubling the
NIH budget by fiscal year 2003, and requests $23.04 billion, an
increase of $2.8 billion, or 13.5 percent above the 2002 level.
NIH is deeply gratified by the support of the American
public and the Congress, and recently, of the administration.
Because of this unprecedented growth in our budget, we are
gaining new knowledge and translating it into new treatments,
diagnostics, and prevention strategies at a remarkable pace.
This is a time of extraordinary scientific opportunity.
As you know, this year we celebrated the mapping of the
human genome, a remarkable accomplishment, but as we look
toward next year, and on to the next decade, our work has only
just begun. The greatest challenges are before us, as are the
greatest rewards. Turning what we know about genes into new
approaches for prevention and management of disease will
require even more intense efforts, and the dedication of our
best and brightest scientists, as well as the continued support
of the Congress and the nation.
To this end, NIH is expanding and developing a variety of
new initiatives and programs aimed at seizing these new
opportunities in all aspects of biology and medicine, from
animal and human molecular studies, and stem cell biology, to
clinical studies. We are expanding our clinical research
programs in an effort to attract new young physicians into
careers in research, so we are supporting several new loan
repayment programs.
We are expanding our training programs and research efforts
in bioinformatics and computational biology, so that we have
the expert tools and personnel to get the most out of a
landslide of information emerging from genomics, proteinomics,
and imaging technologies, and we are using this new technology
and this new knowledge to reach out to the public and to the
health-care providers to help ensure that state-of-the-art
information regarding the prevention, diagnosis, and treatment
of disease is incorporated into the delivery of care.
As you know, in this regard, just last week, the National
Heart, Lung, and Blood Institute issued major new practice
guidelines on the prevention and management of high cholesterol
levels in adults, the first major update in almost 10 years,
and as reported just last Sunday in The Washington Post, the
statins, originally developed to lower cholesterol levels
appear to lower the risk of stroke, diabetes, and Alzheimer's
Disease, as well as the rejection of certain transplants, and
to affect many other disorders as well.
prepared statements
Mr. Chairman, I have kept my remarks brief, but I and the
Institutes directors are here to answer your questions, and to
elaborate, and to assure you that the accomplishments made as a
result of the research will go on in the future. Thank you.
Senator Specter. Thank you very much, Dr. Kirschstein.
[The statements follow:]
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. I am honored
to appear before the Subcommittee, representing my colleagues, the
Directors of the 27 Institutes and Centers who each have presented a
written statement related to the President's budget for fiscal year
2002. I shall present an overall view of the total Administration
budget for NIH in fiscal year 2002.
The NIH is deeply gratified that, beginning in fiscal year 1999,
the support of the American public, the Congress, and the
Administration produced a commitment to double its funding by 2003.
Because of that additional funding, progress in the medical sciences is
advancing at a speed we only dreamed of a few years ago. This is a time
of extraordinary scientific opportunity.
Last June, the International Human Genome Consortium completed a
working draft of the human genome sequence. More than 30 genes for
human diseases and disorders, including various cancers, deafness, and
birth defects, have already been identified using this working draft,
and scientists are now using the information to design better means of
diagnosing and treating these disorders and of identifying other genes.
New insights and knowledge in biology and new tools, including advanced
imaging techniques, computing power, and robotics, allow scientists to
move from studying a single gene and protein to studying entire sets of
genes and proteins and understanding their interactions. In all fields
of medical research, we are now ready to move even more rapidly into
clinical studies, the means of bringing advances directly to the
patient.
The NIH Institutes and Centers have strategically invested the
increases provided since 1999 to take advantage of the enormous
scientific opportunities and to address essential health needs.
Although scientific accomplishments often take many years to unfold
into new diagnostic tools, treatments, and ways to prevent disease
before it strikes, we can already see progress stemming directly from
the increased funding. I will cite a few examples that Institute and
Center Directors have recorded.
A new project funded by the National Cancer Institute (NCI)
supports scientists who are developing detailed profiles, at the
molecular level, of tumors and cancers of the lymphatic and blood
system. The scientists used microarray technology to look at how
thousands of genes are expressed at once, a scale previously
unimaginable. This new project, looking at approximately 1.8 million
measurements of gene expression from 96 different samples, revealed
that there are two distinct subtypes of a malignancy called diffuse
large B-cell lymphoma (DLBCL). Before this finding, clinical
researchers had been unable to account for the fact that 40 percent of
patients with DLBCL respond well to current treatment, yet the
remainder die of the disease. This is just the first demonstration of a
technique that promises to revolutionize diagnosis and treatment for
lymphoma as well as for other cancers.
The National Institute on Drug Abuse (NIDA) was able, in fiscal
year 1999, to use its increased funds to jump-start the establishment
of what has now become a national clinical research infrastructure for
testing treatments for drug addiction. From past research, we know that
treatment of drug abuse can be effective, but these treatments had not
been adequately applied in community treatment centers. The National
Drug Abuse Treatment Clinical Trials Network (CTN), which was expanded
in fiscal year 2000, now provides the infrastructure to bring new
treatments to diverse populations of patients across the country. Since
the inception of the CTN, rapidly and systematically it has grown to
include 14 research centers across the country working in partnership
with over 80 community treatment providers. Patients are already
participating in the first seven treatment protocols, which use both
medications that counter addiction and behavioral approaches. Patient
brochures have been published in English and Spanish, and an additional
17 new protocol concepts have been submitted to NIDA for review.
Language impairment is a serious problem that affects about 7
percent of all school-age children in the United States. It has
significant consequences for families and for society as a whole,
particularly in regard to cost of education and vocational training.
There has never been a good evaluation of the effectiveness of the
usual interventions for language impairment. A recently developed
computerized method called Fast For Word has received national
attention. Scientists supported by the National Institute of Deafness
and Other Communication Disorders (NIDCD) are conducting a randomized
clinical study to compare this intervention, which uses acoustically
modified speech with computer assistance, to computer assistance alone
and to other individualized interventions. The goal is to determine
which intervention leads to the greatest improvement in language, the
greatest gains in being able to converse, and the greatest gains in
auditory perception, as well as being the most cost effective.
These examples illustrate some of the ways the Institutes and
Centers have invested the budget increases since fiscal year 1999. They
not only show great progress over the short-term, but also illustrate
what is required today, in terms of technology and infrastructure, to
take advantage of scientific opportunity and move basic findings into
the practice of medicine.
The President's fiscal year 2002 budget reflects the continuing
commitment to doubling the NIH budget by fiscal year 2003, requesting
$23.04 billion, an increase of $2.8 billion, or 13.5 percent more than
for fiscal year 2001.
Investments have already expanded our knowledge and the practice of
medicine as they have pushed back frontiers. They have also revealed
new frontiers-new opportunities to understand diseases, to treat them,
to prevent them, and even to cure them. As a result, the Institutes and
Centers have many new research projects underway, all of which will
continue well beyond 2003. And given the accelerating rate of progress
and discovery, it is clear that more opportunities will present
themselves. We must seize these future opportunities. To illustrate, I
will present examples from four areas of research offering particular
promise to yield enormous benefits in the form of new knowledge, new
treatments, and new strategies for prevention of disease and
disability.
genomics and genetic medicine
Now that a draft of the human genome sequence has been completed
and is available to all scientists in a public database maintained by
the NIH, opportunities abound. For example, future large-scale
sequencing will be aimed at developing data to help scientists
interpret the human sequence. One of the most efficient ways to do this
is to obtain the genetic sequences from related organisms. A comparison
between the genomes of the human and other organisms such as the non-
human primates, mouse, rat, fruit fly, and yeast will help identify
important features which point scientists toward genes likely to cause
human disease.
There are a number of disorders that are primarily due to
alterations in a single gene. How that disease manifests itself is
complex and varies greatly among patients. These differences, thought
to be caused by other genes that influence the disease-causing genes,
will be a focus of research. Studying these so-called modifier genes
will help us understand variations in the rate at which disease
progresses and how individuals respond to therapy. In addition, these
studies will enable earlier diagnosis and more accurate prognosis, and
may even provide novel targets for therapy that are more useful than
the gene primarily involved in causing a disease.
Together these approaches will help us identify genes involved in,
for example, heart, lung, and blood disorders; cancer; mental and
developmental disorders, including Alzheimer's disease and autism;
diabetes; kidney disease; the muscular dystrophies; and the causes of
aging; adverse reactions to drugs; and babies born full-term but with
low weight.
clinical research: taking basic discoveries into medical practice
The NIH will continue to expand its emphasis in fiscal year 2002 on
clinical research, the means by which basic findings relating to
behavior, to molecules, and to genes, can be tested and translated into
medical practice and improvements in public health.
Several Institutes will begin or will expand their clinical trials
networks located nation-wide, ready to evaluate new prevention
strategies, drugs, and vaccines in large numbers of patients. Other
initiatives in clinical research planned for fiscal year 2002 include
regional centers of excellence for research on rare diseases, research
on care at the end of life, and the self-management of the chronic
illnesses which plague our society.
The NIH is expanding its programs aimed at building the capacity to
conduct clinical research. For example, the 106th Congress authorized
several new Loan Repayment Programs (LRPs), which we regard as vitally
important in recruiting new clinical researchers. Two of these new
programs, the Extramural Clinical Research and the Pediatric Research
LRPs will be trans-NIH programs that will be supported by nearly all
the Institutes and Centers in the fiscal year 2002 President's request.
In addition, we will support the Clinical Research LRP for Individuals
from Disadvantaged Backgrounds and the LRP for Minority Health
Disparities Research. Two programs started in fiscal year 1999, the
Mentored Patient-oriented Research Career Awards and the Mid-Career
Investigator Awards in Patient-oriented Research, will be expanded to
meet the increasing demand for clinical investigators of high quality.
Participation of patients and other volunteers in clinical research
is critical to progress. The NIH's national clinical trials database,
called ClinicalTrials.gov, continues to provide the public with
enhanced access to new information about clinical trials. In addition
to learning about NIH-supported clinical trials, the public can gain
access to information about such trials for serious or life-threatening
conditions sponsored by other Federal agencies as well as by industry.
This expanded capacity provides an even greater array of facts about
which clinical trials are being conducted and whom to contact about
participating in them.
infrastructure and enabling technologies
As medical research generates more and more data, there is a
pressing need for scientists with expertise in biocomputing and
bioinformatics. To meet this need, the NIH will significantly expand
its current program in bioinformatics and computational biology. New
research initiatives will include: Centers of Excellence in
Biocomputing and Bioinformatics, grants to institutions to train people
in these areas of science, and a joint NIH/National Science Foundation
program to support research in mathematical biology.
Rapid progress in medical research is more and more dependent upon
the availability of advanced instruments and other devices that often
cost well in excess of half a million dollars each. The fiscal year
2002 President's budget request provides funds so that the NIH can
support high-end instrumentation for basic and clinical scientists.
Such instrumentation includes very high-field NMR spectrometers,
extremely sophisticated imaging systems and electron microscopes, high-
resolution mass spectrometers, and high-performance supercomputers.
The fiscal year 2002 President's budget also requests $40.2 million
for the newly legislated National Institute of Biomedical Imaging and
Bioengineering (NIBIB), the focus of which is to develop new knowledge,
create new technologies, and train researchers able to integrate fully
the quantitative sciences with medical research. The programs described
above are over and above the $1.2 billion the Institutes and Centers
currently devote extramurally to the physical sciences, including
mathematics, chemistry and other physical sciences.
eliminating health disparities
We are expanding our commitment to programs focused on the health
needs of minorities and the medically underserved, as well as programs
designed to increase the number of minority scientists.
The new National Center on Minority Health and Health Disparities
(NCMHD) was established in December 2000 and is leading NIH's efforts
to plan and coordinate research focused initially on racial and ethnic
disparities. The Center's mission will expand to include studies
related to medically underserved populations, including people who live
in rural settings remote from medical care. The President's budget for
fiscal year 2002 requests a 20 percent increase to $158.4 million for
the new Center over the fiscal year 2001 estimate. In addition, the
budget for the Office of Research on Women's Health would increase by
about $28 million, to nearly $50 million in total, to support new
research and career development for women in science.
The other Institutes and Centers will continue to expand their
emphasis on health disparities as well. For example, a major clinical
trial involving African-Americans is designed to identify ways to slow
the progression of kidney disease due to hypertension. The study
compares two major classes of drugs used to treat high blood pressure--
beta blockers and ACE inhibitors and, when completed, will enable the
NIH to provide and disseminate information about the optimal treatment
of hypertension to prevent end-stage kidney disease in this minority
group. NIH will also award grants to establish formal partnerships
between NIH-designated cancer centers and minority-serving institutions
such as historically black, Hispanic, and tribal colleges and
universities. These partnerships will support research projects and
research training in the minority-serving institutions, foster long-
term collaborations between scientists and faculty that examine the
disproportionate incidence and mortality from cancer in minority
populations, and improve the effectiveness of cancer research,
education, and outreach activities.
This is, Mr. Chairman, only a small sampling of our present and
future research portfolios. The fiscal year 2002 budget request enables
the NIH to sustain momentum of research already in progress, to open
the way to new research opportunities, and to augment both our research
infrastructure and our human capital. In fiscal year 2002, the NIH will
fund 36,143 research grant awards, the highest annual total ever
awarded.
The budget request includes a total of $135 million for the
Institutional Development Award (IDeA) program, an increase of $35
million over fiscal year 2001. This increase will bring our support to
a total of $75 million for the Biomedical Research Infrastructure
Network (BRIN) subcomponent of the IDeA program, which has been
developed to enhance the capacity of institutions located in States
that have not fully participated in medical research, and are eligible
for participation in the IDeA program.
Research and development contracts increase by 20 percent. The
larger increase in R&D contracts, as compared to other extramural
mechanisms, includes $28 million to support the two new loan repayment
programs I described earlier.
The fiscal year 2002 President's budget also includes an increase
of 12.5 percent for Research Management and Support (RM&S). As the NIH
research budget grows, it is important to increase activities under the
RM&S, so that we can effectively manage our programs. The RM&S includes
support for the NIH professional staff who guide and monitor research
activities of the Institutes, for example, those who oversee
protections for volunteers participating in research, and who design
and conduct programs to disseminate the results of NIH research to the
public and to health care professionals.
This request will provide a 10 percent stipend increase for pre-
doctoral and post-doctoral trainees and will permit us to recruit and
retain the best and brightest scientists in careers in medical
research. In the fiscal year 2002 President's budget, Buildings and
Facilities (B&F) would be funded at $306.6 million. Three projects are
particularly important to our research plans: The John Edward Porter
Neuroscience Research Center, the Central Vivarium/Animal Research
Center, and the Building 10 Revitalization Program to repair and
renovate the aging facility used for clinical studies. The budget
request also includes an increase from $75 million in fiscal year 2001
to $97 million in fiscal year 2002 in programs for construction and
renovation of extramural research facilities through the National
Center for Research Resources.
Consistent with the Administration's initiatives to combat drug
abuse, the National Institute on Drug Abuse (NIDA) received an increase
of 16.2 percent in the fiscal year 2002 President's budget request. In
addition, the request includes funds for the Oravax smallpox vaccine
contract managed by the Centers for Disease Control and Prevention ($32
million) and for intra-governmental support for development of anthrax
vaccine ($5 million) and a vaccine production facility ($5 million).
Also included in the budget request is $10 million to begin the
establishment of a system of sanctuaries for chimpanzees to provide
lifetime care when they are no longer needed in research supported by
Federal agencies. This system of sanctuaries was authorized by law in
2000.
Mr. Chairman, this concludes my opening statement. I would be glad
to respond to any questions.
______
Prepared Statement of Duane Alexander, M.D., Director, National
Institute of Child Health and Human Development
Mr. Chairman and Members of the Committee: I am pleased to present
the fiscal year 2002 President's budget request for the National
Institute of Child Health and Human Development (NICHD) of
$1,096,650,000, which reflects an increase of $117,744,000 over the
comparable fiscal year 2001 appropriation.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The mission of the NICHD extends over much of the human life span,
from the time a single egg is fertilized and develops into an infant,
through the childhood and teenage years, through the young adult and
reproductive years, to the health concerns of mature men and women. Our
research seeks to answer questions important to everyone: How can
parents have children at the times they want them? How can all children
be born healthy and mothers avoid the adverse consequences of
pregnancy? How can every child reach adulthood free of disease and
disability, able to achieve his or her full potential? How can we ease
the burden of physical or mental disability to enable all individuals
to participate in society as fully as possible?
Since the Institute was established almost 40 years ago, we have
made enormous strides in answering these questions and improving the
lives of millions of Americans. Through research, we have identified,
and eliminated or reduced, many of the causes of mental retardation and
as a result, far fewer children and adults have mental disabilities.
Through research, we have reduced infant mortality and as a result,
many more infants have grown into healthy children and adults. Through
research, we have found ways to reduce the transmission of the HIV
virus from mother-to-infant and as a result, AIDS in children has
markedly declined in this country. And through research, we have
demonstrated cost-effective methods of significantly reducing the rate
of HIV transmission in developing countries.
We faced formidable scientific challenges in achieving these
advances, and we face many challenges today. Yet these challenges are
dwarfed by the excitement and hope of soon finding answers to questions
we have wondered about for decades.
new technology to help answer a fundamental question
For many years the answer to a critical scientific question has
eluded us: what actually triggers labor in a pregnant woman, at term or
at preterm? We know many things that correlate with a woman going into
labor, but we have never identified the mechanism that triggers labor.
This is an important question. Preterm birth is the leading cause of
infant sickness and death among African American babies and the second
leading cause of infant death among all races. Despite some wonderful
and heartwarming stories that occasionally appear in the media about a
premature infant surviving, the long-term outlook faced by very
premature infants can be bleak.
Now, for the first time, the human genome project has provided us
with the basis for a new technology called microarrays that will allow
us to compare the active genes from pregnant women who begin labor
prematurely with active genes from those who are not in labor or who
deliver their babies after the full nine months. This comparison will
help us to identify the gene products that are responsible for
initiating labor. Armed with this knowledge, we can learn how to stop,
postpone, or, if needed, induce labor. So we have within our reach the
hope of addressing the single biggest cause of infant mortality,
premature birth. And in the process of answering this important
question, we can help eliminate the significant racial disparity in
infant mortality.
new collaborations to eliminate racial disparities in sids
As you know, we have had extraordinary success in reducing another
cause of infant mortality, Sudden Infant Death Syndrome or SIDS. Since
the Institute initiated the Back to Sleep campaign in 1994 to reduce
the risk of SIDS, the death rate from SIDS has declined by 40 percent.
Yet this decline has been less pronounced among African American
infants. In fact, the SIDS rate among African American infants is
greater than twice that of white infants. So in collaboration with
several national African American organizations, we have initiated an
outreach program to reduce the risk of SIDS among African American
infants. The organizations, which include the National Black Child
Development Institute, the Women of the NAACP, the Alpha Kappa Alpha
sorority, and 100 Black Women, among others, are conducting one-to-one
training sessions in communities throughout the country to inform
African American parents and care givers about back sleeping and other
ways to reduce the risks of SIDS.
behavioral interventions to improve learning
Education is a cornerstone of healthy behavior and reading provides
the foundation for education. Children who have difficulty reading are
at risk for failure in school, failure at work, and failure at the many
activities required to navigate successfully as an adult in our
society. NICHD research has demonstrated that using teaching techniques
based on phonemic awareness results in most children being able to read
by the end of the third grade. As you recall, in collaboration with the
Department of Education, as directed by Congress, the Institute
convened a National Reading Panel in 1998 to review the evidence from
reading research and make recommendations for the most effective
methods of teaching children to read. In the largest and most
comprehensive evidence-based review of research on how children learn
reading ever conducted, the Panel reviewed more than 100,000
experimental and quasi-experimental research studies. The Panel report
strongly endorsed the findings and instructional approaches from
NICHD's research. We are now collaborating with the National Institute
for Literacy to disseminate the Panel's findings to administrators,
teachers, and parents.
improving the environment for children to grow
Compared to adults, children are at increased risk from
environmental influences. Children are not just small adults. Yet their
developing bodies are often exposed to the same level of contaminants
as are adults. In some instances, such as ingesting lead from peeling
lead-based paints, children may be exposed to greater contaminants than
are adults. What happens to a child before birth and early in life will
affect the child's subsequent growth, development, and well being
For this reason, the President's Task Force on Environmental Health
and Safety Risks to Children recommended a longitudinal cohort study of
environmental impacts on children to identify and quantify the risks
that children face. Several Federal agencies, among them, the NICHD,
the National Center for Environmental Health of the CDC, and the
Environmental Protection Agency, are participating in planning this
study. The study will enroll 100,000 children, beginning from before
birth, and will gather information on environmental influences and
outcomes until the children reach at least age 21. Methodological and
pilot studies are planned for fiscal year 2001 to 2003 and the full
study will be initiated in 2004. This planning phase will also allow us
to answer key questions about the administration of the study. This is
the largest such prospective study ever undertaken in this country and
we look forward to working with this committee in addressing these
exciting and challenging issues.
reducing hiv and aids among adolescents
The advent of highly active antiretroviral therapy, or HAART, in
the mid 1990s dramatically improved the outlook for many people living
with HIV infection. But for adolescents infected with HIV, HAART posed
a great promise and a greater challenge. The therapy holds the promise
of converting HIV infection into a chronic but manageable condition
that gives young people time to benefit from emerging therapies. The
challenge is that many HIV positive adolescents have little experience
with medications, therapeutic regimens, or adherence to therapy. In the
absence of a strong social support system, many HIV positive
adolescents on HAART do not recognize the importance of taking
medications consistently, on time, every day, without fail. The stakes
are high because if the drugs are taken for short bursts or erratically
over long periods, the probability of drug resistance increases. To
help treat HIV positive adolescents and to develop effective prevention
strategies, the NICHD established the Adolescent Medicine HIV/AIDS
Research Network. By providing training, reinforcement, and a strong
social support system, the Network has demonstrated that adolescents
can be motivated to remain on an exacting medication regimen. Moreover,
the adolescents have been trained in peer counseling techniques and
they are providing a strong prevention message to friends and
classmates in their social network.
autism research
In our autism research, we continue to make important discoveries
that help us understand this condition in the hope of finding more
effective treatments. Recently researchers funded by NICHD and other
NIH Institutes identified a gene that may predispose people to
developing autism. The gene, known as HOXA1, plays a crucial role in
early brain development. This finding strongly suggests that a gene
controlling early brain formation may underlie the development of
autism in a large number of cases. Together with other NIH Institutes,
we are also actively implementing the provision of the Children's
Health Act of 2000 that calls for the establishment of the Centers of
Excellence on Autism Program. As an initial step toward establishing
the Centers, we are issuing Requests for Applications for Center
Development grants which will allow potential Centers of Excellence to
marshal the resources necessary to submit strong proposals when we
request applications for the actual centers.
women's health
Research in women's health continues to be a high priority for the
Institute. We are supporting research to develop effective treatments
for uterine fibroids, the number one reason for hysterectomies and a
leading cause of infertility, particularly among African American
women. With the Office of Research on Women's Health, we are conducting
research to understand, treat, and reduce conditions such as pelvic
organ prolapse and incontinence that can develop as a result of
childbirth or the aging process. We are also conducting research to
diagnose and treat vulvodynia, a particularly painful condition that
affects the reproductive, sexual, and physical health of women. We have
also initiated gender specific-research to understand how women's
unique reproductive physiology influences the transmission and
progression of HIV-1. This research will lay the foundation for new
prevention and treatment strategies to reduce AIDS among women. And
because some conditions such as uterine fibroids, ectopic pregnancies,
and preterm births disproportionately affect African American women,
NICHD has helped establish a collaborative partnership between
reproductive scientists at minority institutions and NICHD-funded
programs. The new Reproductive Science Centers at Minority Institutions
are designed to increase the number of minority investigators trained
to study reproductive health issues, particularly those relevant to
racial and ethnic populations.
In closing Mr. Chairman, I look forward to working with you and the
subcommittee and will be happy to provide answers to any questions you
have.
______
Prepared Statement of Dr. James F. Battey, Jr. Director, National
Institute on Deafness and Other Communication Disorders
Mr. Chairman and Members of the Committee, I am pleased to present
the President's budget request for the National Institute on Deafness
and Other Communication Disorders (NIDCD) for fiscal year 2002, a sum
of $336,757,000 which reflects an increase of $35,631,000 over the
comparable fiscal year 2001 appropriation. 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 second annual performance report which
compares our fiscal year 2000 results to the goals in our fiscal year
2000 performance plan. As performance trends on research outcomes
emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The United States recently celebrated the 10th Anniversary of the
signing of the Americans with Disabilities Act, a law enacted in 1990
to promote integration, equal opportunity, and inclusion of millions of
Americans with a disability. Even with this legislation, individuals
affected by a communication disability may still find it difficult to
enter the labor force and live a productive life because of the daily
challenges they face. It is often impossible for them to perform the
simple acts of speaking, listening, or otherwise making their wants and
needs understood. Disorders of hearing, balance, smell, taste, voice,
speech, and language exact a significant economic, social, and personal
cost for many individuals. The NIDCD supports and conducts research and
research training in the normal processes and the disorders of human
communication that affect approximately 46 million Americans. Human
communication research now has more potential for productive
exploration than at any time in history. With substantive
investigations conducted over the past decades, the advent of exciting
new research tools and new highly trained scientists, the NIDCD is
pursuing a more complete understanding of the scientific mechanisms
underlying normal communication and the etiology of human communication
disorders. Examples of this research are highlighted in this statement
for the record.
The Speed of Sound: Rapid Motor Protein of Inner Ear Identified.--
Millions of Americans, especially middle-aged and older individuals,
suffer from mild to moderate hearing loss. It is likely that a defect
in the most sensitive cell types in the inner ear, the hair cells,
causes this type of hearing deficit. The hair cells of the inner ear
are sensory receptor cells that give humans and other mammals the
remarkable ability to hear. As sound travels to the ears, down the ear
canal, through the bones of the middle ear and into the inner ear, the
outer hair cells amplify the mechanical vibrations produced by the
sound through a process known as electromotility. These electrical
changes in the cell allow it to rapidly change its length and
stiffness. The length changes amplify the vibrations, which are sensed
by the other hair cells (inner hair cells) that send auditory
information to the brain. NIDCD-supported scientists have recently
identified the gene that codes for the motor protein responsible for
outer hair cell electromotility as well. Prestin (from the musical term
presto, indicating a rapid tempo) was selected as the name of the gene
to emphasize one of the most interesting features in the cellular motor
process, its speed in changing the length of outer hair cells. Outer
hair cells can elongate and contract at rates close to 100,000 times a
second! Future research on Prestin should lead to significant advances
in understanding the auditory system, and may lead to the development
of new therapeutic measures for hearing impairment.
Genes Responsible for Hereditary Hearing Impairment.--NIDCD-
supported scientists continue to make impressive scientific progress in
mapping and cloning genes responsible for hereditary hearing
impairment. Over the past few years, the chromosomal location of over
60 genes whose mutation results in hereditary hearing impairment have
been identified. In the past three years, nearly 20 genes have been
identified whose mutations cause hereditary hearing impairment. The
identification of these genes enables scientists or clinicians to
rapidly identify individuals carrying the defective gene even if the
hearing loss has a delayed onset and is not yet evident. In addition,
the identification and isolation of genes responsible for hereditary
hearing impairment immediately provide a powerful tool to determine how
the mutation results in deafness by targeted gene mutations or
deletions in an animal model. The animal model can provide information
on which structures of the ear are affected, as well as the molecular
and physiological defects that result in hearing impairment, and
provide a system to test potential new therapies.
Gene Cloned for Syndrome That Causes Deafness and Blindness.--Usher
syndrome type 1 is an inherited sensory defect involving profound
deafness, balance disorders and eventual progression to blindness. It
is the most common genetic cause of a syndrome leading to blindness and
deafness in Americans. Studies of affected families in the U.S. and
abroad indicate that there are more than six distinct genes whose
mutations result in this devastating inherited disease. NIDCD-supported
scientists are collaborating with researchers from France, Germany,
Lebanon, and Japan to identify the defective gene responsible for one
form of this disorder, USHER1C. They identified the defective USHER1C
gene in unrelated families in the U.S., Lebanon, and Europe. The
finding will allow for genetic-based diagnosis of Usher syndrome before
a deaf individual begins to lose sight. Early diagnosis will permit the
study of the complete progression of retinal degeneration and provide
opportunities in the future for possible treatment before the retinal
degeneration begins.
An Animal Model for Pendred Syndrome.--Individuals with Pendred
syndrome have sensorineural deafness and goiter (enlargement of the
thyroid gland). In a collaboration between National Human Genome
Research Institute and NIDCD intramural scientists, genetic analysis
revealed that mutations in the Pendrin gene occur in deaf individuals
without thyroid disease, indicating that the gene is responsible for a
much broader spectrum of deafness than only those individuals with
Pendred syndrome. To determine the cause of this disorder, the Pendrin
gene was deleted in mice and analysis of this mouse model was
conducted. The mutant mice were found to be deaf and have a variable
spectrum of balance problems similar to symptoms of individuals with
the syndrome. The scientists observed swelling in parts of the
developing inner ear in the mutant mouse embryos. The resulting fluid
imbalance within the inner ear subsequently leads to the destruction of
the sensory hair cells necessary for hearing. This mutant mouse model
provides important clues about inner ear pathology associated with the
human syndrome.
Otitis Media is Linked to a Strong Genetic Component. Otitis media
(OM), or middle ear infection, is the most common reason why a sick
child visits a physician, and is the most common reason that children
receive antibiotics or undergo surgery. Previous anatomical,
physiological, and epidemiological studies have raised the question of
whether the likelihood of having multiple bouts of this common disease
has a hereditary component. Studying twins and triplets to determine
the extent to which this common disease might be due to genetic
factors, NIDCD-supported scientists have determined that there is a
strong genetic component to the rate of occurrence of otitis media in
children. The implications of these findings are numerous for both
immediate and future improvements in treatment of OM. For example,
primary care physicians can follow siblings and offspring of affected
children as potentially high-risk cases. These children could be
monitored more closely for early detection and treatment of disease,
reducing the risk of hearing loss. In addition, identification of the
genetic factors that cause this disease could eventually result in
genetic diagnostic tests to identify individuals with enhanced risk.
Finally, studies of the molecular basis for the increased risk and
frequency of otitis media could lead to new approaches for intervention
and treatment of this disease.
Molecular Biology of Taste Signal Transduction.--A long history of
NIDCD-supported research has shown that taste perception involves four
basic taste qualities: sweet, sour, salty, and bitter. In a recent
study, a fifth taste has been recognized and its taste receptor
identified--umami--the taste of monosodium glutamate or the taste
associated with protein-rich foods. From this finding, scientists have
determined that each taste quality appears to be mediated by a distinct
biochemical pathway. Salty and sour substances activate specialized ion
channels in the membrane of the taste receptor cells in the taste buds
in the tongue. In contrast, umami-, sweet-, and bitter-tasting
substances activate another pathway involving G-protein-coupled
receptors. Scientists recently characterized the diverse structure,
function and expression of a large family of mammalian G-protein-
coupled receptors, called T2Rs, which are selectively expressed in a
subset of taste receptor cells of the tongue and palate. T2R receptors
were shown to mediate bitter taste perception in humans and mice.
The Genetics of Stuttering.--Stuttering is a speech disorder in
which the normal flow of speech is disrupted by frequent repetitions or
prolongations of speech sounds, syllables or words. Currently, there is
no cure for the 3 million Americans who stutter. The precise causes of
stuttering have not been identified but there is evidence that it is
genetically determined. NIDCD intramural scientists have been
conducting a large study that involves individuals who stutter and
their families. From this group, the scientists have recently
identified a single region of the genome that may contain one or more
genes involved in stuttering. Understanding the genetic causes of
stuttering will eventually lead to treatment for this age-old disorder.
Language Impairment in Autism.--NIDCD-supported scientists were the
first to investigate the language profiles on a large sample of
children with autism. One cardinal feature of autism is the delay or
absence of spoken language. In the study, the researchers found
significant differences in language skills, although articulation
skills (or how the sounds of the language are produced) remained normal
in all the children. Different subgroups of children with autism were
identified on the basis of their performance on the language measures.
Some children with autism have normal language skills, while others
have language skills significantly below their age expectations. The
scientists also observed that the performance profile across the
standardized measures for the language-impaired children with autism
was similar to the profile of children with specific language
impairment (SLI). These findings suggest that there may be overlapping
or shared characteristics among families with SLI and autism. Future
studies will need to investigate the mechanisms underlying language
processing in children with SLI, autism and perhaps other disorders, in
order to advance the understanding of language disorders in children.
Expanding Efforts to Identify Hearing Impairment in Newborns.--As
efforts increase in many States to screen all newborn infants for
hearing impairment before discharge from the hospital, more infants
will be identified with hearing impairment at an early age when
appropriate intervention can be started that will optimize their long-
term speech and language skills. NIDCD-supported scientists have
examined the importance of age at enrollment in intervention programs
and subsequent language outcomes for a group of deaf and hard-of-
hearing children. Significantly better language scores were associated
with early enrollment, and high levels of family involvement correlated
with positive language outcomes. These results provide further evidence
that children will benefit when early identification of hearing loss is
combined with an early intervention strategy that actively involves
family participation.
Advances in the genetics of hereditary hearing impairment and in
the early identification of hearing impairment have now converged,
leading some clinicians to suggest genetic testing/evaluation be
performed on all infants who are identified with a hearing loss at
birth. In consideration of these developments, the NIDCD is planning a
study to address the clinical relationship between genetic and
audiologic/otologic information, as well as to assess the clinical
validity, value and utility of genetic testing in the diagnosis,
treatment and management of hearing impairment.
Cochlear Implants Are Cost Effective.--Over 20,000 Americans with
profound hearing impairment have received cochlear implants with
approximately one-half of the recipients being children. This device
converts sound into electrical impulses on an array of electrodes
surgically inserted into the inner ear, bypassing the hair cells and
stimulating the auditory nerve directly. NIDCD-supported studies have
shown that children with cochlear implants exhibit improvements in
speech perception, speech production, and better language and reading
performance. In addition, a recent analysis showed that cochlear
implants improve the children's quality of life, and result in a net
saving to society. The cost benefit is in the form of fewer demands on
special education and greater wage-earning opportunities for implant
recipients.
______
Prepared Statement of Dr. Marvin Cassman, Ph.D., Director, National
Institute of General Medical Sciences
Mr. Chairman and Members of the Committee, good morning. I am
pleased to present the President's budget request for the National
Institute of General Medical Sciences (NIGMS) for fiscal year 2002, a
sum of $1.720 billion, which reflects an increase of $180 million over
the comparable fiscal year 2001 appropriation.
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 second performance report,
which compares our fiscal year 2000 results to the goals in our fiscal
year 2000 performance plan. As performance trends on research outcomes
emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The NIGMS mission is to support basic biomedical research in
disciplines ranging from genetics, chemistry, and cell biology to
trauma and burn research. These studies, often carried out in organisms
such as yeast, fruit flies, and bacteria, yield a fundamental
understanding of the biological processes that underlie all of the
functions of life. Insights into the basic behavior of living systems
provide the underpinning for subsequent discoveries regarding the way
these processes go awry and lead to disease.
It is becoming increasingly clear that research started with the
goal of understanding unknown or poorly understood processes can
immediately lead to insights about the mechanisms underlying diseases.
One example is a research effort focused on a rather esoteric protein
that is involved in the way cells process the instructions from DNA. As
part of this study, the NIGMS-supported investigators closely examined
the makeup of the protein. From its somewhat unique structure, they
inferred that the protein could trigger diseases that result from the
body's reaction to its own materials, a process known as autoimmunity.
Interestingly, this discovery was entirely incidental to the original
investigations. When the scientists tested this hypothesis, they found
a strong correlation between high levels of immune response to this
protein and the occurrence of a disease called systemic lupus
erythematosus. This suggests that the occurrence of lupus is a
consequence of some aberrant event that results in the accumulation of
this protein or in the body's response, or both. We anticipate that
this discovery will provide a major tool to allow accurate diagnosis of
lupus as well as a clue to possible cures.
Another example of the rapid conversion of a basic understanding of
biology to an understanding of disease processes is found in studies
being done on copper. Although copper is most often associated with
pennies or the pipes used in plumbing, the metal is also an essential
component of biological systems. However, when free in cells and
organisms, even a small amount of copper can be very toxic. How does
the body process copper in a way that does not cause irreversible
damage? NIGMS grantees discovered proteins that ``chaperone'' copper
and protect it from interacting with other cellular components until it
reaches its proper destination. These proteins are called
``metallochaperones.'' Some are specific for transporting copper, and
some are specific for transporting other essential metals. There are
several known hereditary diseases that are the result of defective
copper metabolism, and these diseases frequently cause
neurodegenerative disorders. It is important to understand just what is
going wrong in individuals with these problems. Recent detailed studies
on the mechanism of copper transport have shown how the chaperones that
carry copper are implicated in the events leading to these diseases.
Finally, a major thrust in modern medicine is the attempt to
understand individual responses to drugs based on a person's genetic
make-up. For example, certain drugs used to treat cancer can have
widely variable effects in patients, and many of these treatments have
serious toxicities. On occasion, patients are literally poisoned
because their bodies cannot get rid of, or ``clear,'' a drug. For
example, patients given the same dose of a commonly used chemotherapy
drug, docetaxel, can have wide variations in the amount of time it
takes to clear the medication. A solution to this problem may come from
many years of basic studies on the behavior of a drug-metabolizing
protein nicknamed ``CYP3A4.'' This protein chews up many different
drugs, including docetaxel. An NIGMS grantee has developed a simple
breath test to measure the activity of CYP3A4, and a small clinical
study has shown that patients who exhibit low activity of the protein
suffer the greatest docetaxel toxicity. Since blood tests have
previously failed to predict docetaxel toxicity, the breath test may
offer a promising tool to help physicians administer this drug more
safely.
recent research initiatives
NIGMS has recently begun a number of major research initiatives,
and I would like to describe our progress in three of them. The first
is in the area of pharmacogenetics, an example of which is the
docetaxel toxicity research I just described. The goal of this research
initiative is to identify the genetic basis of individual variations in
drug response, and ultimately to develop tools that will allow
individual differences to be determined before drugs are prescribed. We
have funded 9 research groups for a total of $12.8 million in the first
year. NIGMS leads the research initiative, and five other NIH
components are cofunding projects. The other NIH components are the
National Heart, Lung, and Blood Institute; the National Cancer
Institute; the National Human Genome Research Institute; the National
Library of Medicine; and the National Institute of Environmental Health
Sciences. The centerpiece of the program is the development of a
database that will link gene variations to their cellular and molecular
consequences, and ultimately to their physiological outcomes. Because
many of these studies will initially be on defined populations we have
established a Populations Advisory Group to provide advice on how to
best proceed with such research. We established a second advisory group
to provide a liaison to the pharmaceutical industry. Although this
industry is doing a great deal of work in pharmacogenetics, much of it
is proprietary. However, there are opportunities for mutually
beneficial interactions, and this advisory group has been established
to identify those areas.
The second major research initiative is in the area of structural
genomics. The goal is to determine the three-dimensional structures of
all proteins in nature, through a combination of direct experiments and
theoretical analysis. Proteins are the worker molecules in every living
thing. By determining the structures of proteins, we are better able to
understand how each protein functions normally and how faulty protein
structures can cause disease. Scientists can use the structures of
disease-related proteins to help develop new medicines and diagnostic
techniques.
The project was begun in September 2000 through funding nearly $30
million worth of awards to seven consortia that total 41 participating
institutions. These are pilot programs to determine the most effective
approaches that will result in rapid production of detailed protein
structures. It is important to note that the NIGMS research initiative
is part of a world-wide activity in structural genomics that also
includes several industrial participants. Together with the Wellcome
Trust in the United Kingdom, NIGMS organized an international
structural genomics meeting that was held in England in April 2000. A
second international meeting was held in the Washington, DC area in
April 2001.
The third Institute research initiative provides support to ``glue
together'' groups of investigators working on significant problems that
could not be solved if the scientists worked independently. Like the
other two research initiatives, it involves the formation of a network
of researchers who collaborate and share their results to speed
progress toward a major goal. All of these projects reflect changes in
how biomedical research is done today. There is an increased emphasis
on large-scale and collaborative approaches to important scientific
questions. These include studies of complex systems that involve the
interaction of many components, such as all of the activities that go
on within a single cell and the ways that cells and organs ``talk'' to
each other.
Studying complex systems requires the contributions of more than
just biological scientists. It requires the expertise and approaches of
physicists, mathematicians, computer scientists and engineers, all of
whom are in a unique position to organize and analyze the vast amounts
of data generated by studies of complex systems. To address this need,
NIGMS has started programs to encourage these scientists to join their
expertise and interests with those of biomedical researchers.
research training
NIGMS remains committed to preparing ``a cadre of versatile
scientists and engineers for research and teaching careers,'' investing
in ``an educational system that creates a reservoir of flexible talent
for the work force,'' and ensuring ``opportunities for the
participation of all groups in science and engineering.'' These goals,
which are quoted from a 1998 Office of Technology Assessment report on
the objectives of Federal training programs, mirror the Institute's
interests. We accomplish these goals through a variety of mechanisms,
two of which I will mention. The first is our predoctoral training
programs, which have been widely recognized as a means of identifying,
stimulating, and rewarding quality research training. They encourage
interdisciplinary training, which is a central requirement of all of
our training programs. Two recent reports, one by the National Academy
of Sciences and one an internal NIH study tracking the career
progression of former trainees, have noted the value of these programs
in generating a highly qualified group of investigators.
In order to encourage ``opportunities for the participation of all
groups in science and engineering,'' we require that our training
programs make active efforts to recruit and retain underrepresented
minorities. Additionally, our Minority Access to Research Careers
(MARC) Program has a strong focus on research training, primarily at
the undergraduate level. In fiscal year 2000, we supported 644 students
at 62 institutions through this program. Although this is a program of
very long standing, since 1975, we have several other programs focusing
on the training of underrepresented minorities in science, a number of
which have been initiated in the past few years. These programs are
coupled to intensive outreach efforts that are designed to improve the
capabilities of institutions to participate in Federal programs and to
identify new approaches to bring underrepresented minorities into
biomedical research.
health disparities
NIGMS has several special activities in the area of health
disparities. One is a new collaboration with the Indian Health Service
to enhance the capacity and skills of tribal organizations and Native
American researchers to conduct high-quality biomedical and behavioral
health research and to apply successfully for competitive research
grants.
By its very nature, our pharmacogenetics research initiative will
likely reveal new information linking differences in response to
medicines with genes that are more common in certain population groups.
Such knowledge could contribute to a reduction in health disparities by
improving doctors' ability to identify and treat individuals who have
these genes. Beyond these general benefits, we are planning to offer
research grant supplements for studies that are specifically related to
health disparities in response to medicines.
Finally, a proposed NIGMS health disparities initiative would focus
on differences between various population groups in the physiological
response to traumatic injury. New information about such differences
could improve doctors' ability to anticipate how trauma patients are
likely to fare, especially which patients are at higher risk of
developing a potentially fatal complication called systemic
inflammatory response syndrome.
conclusion
In conclusion, NIGMS sustains and develops programs that provide
the research and research personnel required to ensure the continued
progress of biomedical research. Our many accomplishments attest to our
success in this endeavor, and our recent research initiatives should
help us make even more significant contributions to the biomedical
research enterprise in the years ahead.
Thank you, Mr. Chairman. I would be pleased to answer any questions
that you may have.
______
Prepared Statement of Dr. Francis S. Collins, M.D., Ph.D., Director,
National Human Genome Research Institute
Mr. Chairman and Members of the Committee: During fiscal year 2000,
Human Genome Project scientists capped the achievements of the last
decade with a historic milestone--the complete initial reading of the
text of our genetic instruction book. At present, roughly 93 percent of
the 3.1 billion bases of the human genome are freely available in
public databases. This is an awesome step toward a comprehensive view
of the essential elements of human life, a perspective that inaugurates
a new era in medicine where we will have a more profound understanding
of the biological basis of disease and develop more effective ways to
diagnose, treat, and prevent illness.
Between March 1999 and June 2000, the production of human genome
sequence skyrocketed. During this time, the international collaborators
in the Human Genome Project sequenced DNA at a rate of 1000 bases per
second, 7 days a week, 24 hours a day. After completing the working
draft of the human genome sequence in June of 2000, Human Genome
Project scientists and computational experts began to scour the
sequence for insights. They reported the first key discoveries in the
February 15, 2001 issue of the journal Nature. Among the findings were
the following:
--Humans are likely to have only 30,000 to 35,000 genes, just twice
as many as a fruit fly, and far fewer than the 80,000 to
150,000 that had been widely predicted.
--Genes are unevenly distributed across the genomic landscape; they
are crowded in some regions and spread out widely in others.
--Individual human genes are commonly able to produce several
different proteins.
--More than 200 human genes arrived to the genome of some ancestor
directly from bacteria.
--The repetitive DNA sequences that make up much of our genome, and
commonly regarded as ``junk,'' have been important for
evolutionary flexibility, allowing genes to be shuffled and new
ones to be created. The repetitive DNA may also perform other
important functions.
finishing the human genome sequence
Because of the enormous value of DNA sequence information to
researchers around the world, in academia and industry, NHGRI has
always been committed to the principle of free, rapid access to genomic
information through well-organized, annotated databases. Databases
housing the human genome sequence are being visited an average of more
than 50,000 times a day. In fiscal year 2002, NHGRI will increase the
usefulness of the human genome sequence to the world's researchers by
finishing the sequencing to match the project's long-standing goals for
completeness and stringent accuracy. More than a third of the draft
sequence already has been finished into a highly accurate form--
containing no more than 1 error per 10,000 bases. Finished sequence for
the entire genome is expected by 2003. Finished sequence is already
available for the entire lengths of chromosomes 21 and 22. Genes on
chromosome 21 are involved in Down syndrome, Alzheimer disease, certain
cancers, and manic depressive illness, while those on chromosome 22 are
implicated in the workings of the immune system, in congenital heart
disease, schizophrenia, mental retardation, and several cancers,
including leukemia. Researchers can now study the molecular bases of
the conditions linked to these chromosomes systematically and
comprehensively, and the same high standard of completeness will be
achieved for the other 22 human chromosomes over the next two years.
genome sequences of non-human species
In the coming year, NHGRI and its partners will sequence the
genomes of important model organisms, including the mouse and rat. The
Human Genome Project's goals always included the analysis of the
genomes of species that have been important to laboratory research.
Having genome sequence from additional species is one of the most
efficient tools for interpreting the human sequence, because many of
the most important elements in our genome--including genes and the
regions that regulate their expression--are conserved in the genomes of
other species. Genome sequences from the well-studied laboratory mouse
and rat will be especially useful because, as mammals, their genomes
are relatively similar to the human genome and because they have long
provided insights into the molecular basis of disease.
The Mouse Sequencing Consortium formed in October 2000 and in April
2001 produced a publicly accessible draft sequence covering 95 percent
of the mouse genome, a result of the collaborative efforts of three
private companies, six institutes of the NIH, and a British charity,
the Wellcome Trust. The Consortium will now go through the more arduous
process of filling in gaps in the draft and will produce high-quality
finished sequence no later than 2005. Already, the mouse data is saving
researchers a great deal of time. For example, researchers at Merck
recently found a mouse relative of a human gene implicated in
schizophrenia by scanning the newly available mouse genome sequence.
Alterations in the human gene were found in a large Scottish family
where schizophrenia correlates with a chromosomal rearrangement.
Researchers had searched without success for years for the related gene
in mouse, but the mouse genome sequence readily revealed the
corresponding mouse gene in a computer search taking only seconds. The
researchers can now test the effects of inactivating the gene on the
mouse brain, perhaps giving clues to the molecular basis of
schizophrenia in humans.
Meanwhile, the laboratory rat, long used for a wide range of
medical research, including studies on high blood pressure, cancer, and
drug metabolism, is getting its share of attention. In February, NHGRI
and the National Heart, Lung and Blood Institute announced a plan for
sequencing the rat genome. The institutes will fund private companies
as well as academic labs; all have agreed to release data weekly into
public databases.
Other model organisms' genomes are undergoing study as well. NHGRI
is funding scientists at the University of California at Berkeley and
the Baylor College of Medicine to close the gaps in the fruit fly
genome sequence and to ensure that the finished sequence meets quality
standards for finished sequence data. In fiscal year 1999, NHGRI and
the National Cancer Institute, leading 15 other NIH institutes,
launched the Mammalian Gene Collection, whose goals are to develop
analysis tools and to produce a collection of full-length copies of
genes, which can be sent to researchers on demand. So far, nearly
20,000 full-length gene copies have been identified and are slated for
sequencing.
human genetic variation
For understanding the basis of common diseases with complex
origins, like heart disease, Alzheimer disease, and diabetes, it is
important to catalog genetic variations and how they correlate with
disease risk. Among any two people, an average of one DNA spelling
variation--or SNP--exists in every 1000 bases. With a draft of the
human genome sequence in hand, the pace of SNP discovery has increased
dramatically. In fiscal year 1999, NHGRI organized the DNA Polymorphism
Discovery Resource consisting of 450 DNA samples collected from
anonymous American donors with diverse ethnic backgrounds. NHGRI has
funded studies looking for SNPs in these samples. The non-profit SNP
Consortium came into being in April 1999, with the goal of developing a
high-quality SNP map of the human genome and of releasing the
information freely. Consortium members include the Wellcome Trust, a
dozen companies (mostly pharmaceutical companies), and three academic
centers; they have looked for SNPs in DNA from a subset of the samples
in the DNA Polymorphism Discovery Resource. In July 2000, the NHGRI and
The SNP Consortium announced a collaboration that has allowed the
contribution of 5 times more SNPs to the public domain than the
consortium originally planned. As of March 28, the public database that
serves as a central repository for SNPs has received 2,840,707 SNP
submissions.
With the increased knowledge about human variation, the genetic
underpinnings of various diseases, including diabetes, are being
discovered. The recent discovery of a gene, calpain-10, whose
disruption contributes to diabetes, resulted from studies linking
diabetes with genetic variations across the whole genome and then in a
specific part of chromosome 2. The newly-discovered gene suggests that
a previously unknown biochemical process is involved in the regulation
of blood sugar levels. Diabetes is also one of the areas of focus for
intramural research at NHGRI.
Investigators from Howard University and NHGRI are engaged in a
project looking for genetic risk factors for diabetes in West Africans.
This is part of a wider collaboration between the two institutions to
study the genetic basis of diseases that disproportionately affect
African-Americans. The diabetes study focuses on West Africans since
they are thought to be the population from which modern African-
Americans are largely descended, and the Africans are not exposed to
the same dietary risk factors as Americans. Study recruitment centers
were opened in Nigeria and Ghana; in the fall of 2000, researchers met
their goal of recruiting 400 pairs of siblings affected with diabetes.
Genetic typing of the collected tissue samples is in progress at
NHGRI's Center for Inherited Disease Research in Baltimore to search
for genetic variations that increase susceptibility to diabetes.
Meanwhile, other intramural investigators are part of a consortium
where researchers pool a wide range of data about the genetic factors
underlying diabetes. One of the studies, called FUSION (Finnish U.S.
Investigation Of Non-insulin dependent diabetes mellitus) has collected
DNA samples and clinical data from 5000 Finnish people who have
diabetes; many of the individuals are related. A genome-wide search
among these people for genes related to diabetes risk has so far
identified two areas on chromosome 20 that are likely to contain
crucial genes.
gene expression
The new-found abundance of genomic information and technology is
propelling scientists out of the pattern of studying individual genes
and into studying thousands at a time. Large-scale analyses of when
genes are on or off (gene expression) can be used, for example, to
study the molecular changes in tumor cells. This exciting new approach
combines recombinant DNA and computer chip technologies to produce
microarrays or DNA chips. Classifying cancer on a molecular level
offers the possibility of more accurate and precise diagnosis and
treatment. Intramural researchers at NHGRI have used large-scale
expression studies to discover genetic signatures that can distinguish
the danger from different skin cancers and that can distinguish between
hereditary and sporadic forms of breast cancer.
protein structure, function, and interaction
With a global view of human genes now possible, scientists are
eager to obtain a similarly comprehensive view of human proteins, a
field called proteomics in analogy to genomics. Researchers want to
know the functions of proteins and how the proteins work together in
cells. Only a subset of all possible proteins are present in any given
cells at any given time. To study protein function on a wide scale,
various groups of researchers plan to identify the locations of
proteins, their levels in different cells, their structures, the
interactions among different proteins, and how they are modified. NHGRI
is contributing to this field by developing technologies for efficient,
large-scale analyses, particularly for determining protein interactions
and measuring protein abundance in different cells.
centers of excellence in genomic science
In fiscal year 2001, NHGRI will award the first grants under a new
program to bring cross-disciplinary teams of researchers together with
shared resources and a unified goal. The Centers of Excellence in
Genomic Science are designed to develop new genomic approaches for
analyzing the molecules of life systematically, to integrate technical
developments into biomedical research, and to expand training
opportunities. Additional centers will be funded in fiscal year 2002 to
develop new ways of undertaking genome-wide analyses in areas like the
regulation of gene expression, protein expression and interaction,
human genetic variation, and the storage and analysis of the flood of
new data. These centers are expected to be a source of creative
approaches addressing previously unanticipated questions. As training
centers, they will give high priority to the training of people from
racial or ethnic minority groups, women, and people with disabilities.
promise for new treatments and prevention
Genetic testing will become increasingly important for assessing
individual risk of disease and prompting programs of prevention. An
example of how this may work involves the disease hereditary
hemochromatosis (HH), a disorder of iron metabolism affecting about one
in 200 to 400 Americans. Those with the condition accumulate too much
iron in their bodies, leading to problems like heart and liver disease
and diabetes. The gene causing the condition has been identified,
allowing early identification of those in whom HH may develop. Once
people at risk are identified, they can easily be treated by
periodically removing some blood.
Genetic testing is also being used to tailor medicines to fit
individual genetic profiles, since drugs that are effective in some
people are less effective in others and, in some, cause severe side
effects. These differences in drug response are largely genetically
determined. Customizing medicine to a patient's likely response is a
promising new field known as pharmacogenomics. A recent publication in
the journal Hypertension showed how pharmacogenomics applies to high
blood pressure. Researchers found a variation in a particular gene that
affects how patients respond to a commonly used high blood pressure
drug, hydrochlorothiazide. Other recent studies reveal that doctors
should avoid using high doses of a common chemotherapy treatment (6-
mercaptopurine) in a small proportion of children with leukemia.
Children with a particular form of a gene (TPMT) suffer serious,
sometimes fatal, side effects from the drug.
Genomics is also fueling the development of new medicines. Several
drugs now showing promising results in clinical trials grew out of
genomics-related studies. One example is Glivec (previously called
STI571), produced by Novartis for treating chronic myelogenous leukemia
(CML). In CML, an abnormal gene fusion creates an abnormally activated
protein. Novartis designed a small molecule that specifically
inactivates the protein. In phase I clinical trials, this drug caused
favorable responses in 53 of 54 patients, while side effects were
minimal no matter how high the dosage. Meanwhile, Bayer and Millennium
announced the development of another cancer drug born of genomics in
January 2001. GlaxoSmithKline is testing a new genomics-derived heart
disease drug that targets a protein involved in fat metabolism. Johnson
& Johnson is testing a drug targeting a brain receptor involved with
memory and attention. Human Genome Sciences has four clinical trials in
progress to test gene-based drug candidates.
ethical, legal, and social implications
From its inception, NHGRI recognized its responsibility to address
the broader implications of having access to genetic information and
technology. Since 1991, it has committed 5 percent of its budget to
studying the ethical, legal, and social implications (ELSI) of genome
research. Study of human genetic variations raises many ELSI issues.
The case of hemochromatosis brings up some of these issues. Given the
devastating complications from HH and the simple treatment, some have
proposed widespread genetic testing to find those predisposed to HH.
But considerable uncertainty remains about how strong the link is
between particular gene variants and the presence and severity of HH
disease. In fiscal year 2000, NHGRI and the National Heart, Lung and
Blood Institute began a 5-year, $30 million epidemiological study among
100,000 adults to gauge, among other things, the prevalence and the
genetic and environmental causes of HH. NHGRI is funding an examination
of the ethical, legal, and social issues related to implementing a
widespread screening program. Information from the study should yield
insights not only for HH but also for other treatable adult-onset
genetic disorders.
Many ELSI issues raise policy implications; one is how to deal with
potential employment discrimination. Two years ago, a Time/CNN poll
showed that 95 percent of those polled thought employers should not
have access to genetic information about employees without their
permission. A recent case, involving the Burlington-Northern Santa Fe
railroad, shows what can happen. In March 2000, BNSF added testing for
a gene (PMP22), which may be the cause of carpal tunnel syndrome in a
small population of people with the disorder, to the medical evaluation
of employees who file workers' compensation claims for carpal tunnel
syndrome, to test whether the carpal tunnel syndrome was ``work-
related.'' Employees were not told that their blood would be submitted
for a genetic test. In February, the Equal Employment Opportunity
Commission and the workers' union filed suit against BNSF. The company
has now stopped genetic testing and agreed to seek approval from the
union before doing any genetic testing in the future. While this is a
happy ending for this particular case, comprehensive public policy will
be required as genetic tools become more widespread. The ELSI program
at NHGRI will continue to form policy recommendations that balance the
need to protect individuals with the needs of the research community
and the healthcare industry.
Finally, as part of its mission of education, NHGRI produced a free
educational kit, ``The Human Genome Project: Exploring our Molecular
Selves,'' that was released when the human sequence analysis was
published in February. The kit includes a multimedia CD-ROM, an award-
winning video documentary, and an informational brochure. The kit is
designed to give science teachers and classrooms, particularly at the
high school level, better access to the latest information about genome
science and its implications, but it is expected to be used more
broadly, by college students, voluntary health organizations, and the
general public. Backing from Howard Hughes Medical Institute and
Pharmaceutical Research and Manufacturers of America (PhRMA) insured
that the kit, sponsored by the NIH and DOE, would be available for
free. Nearly 40,000 kits have been requested in just two months.
I am pleased to present the President's budget request for the
National Human Genome Research Institute (NHGRI) for fiscal year 2002,
a sum of $426,739,000, which reflects an increase of $44,627,000 over
the comparable fiscal year 2001 appropriation. 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 second annual performance report which
compares our fiscal year 2000 results to the goals in our fiscal year
2000 performance plan. As performance trends on research outcomes
emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
______
Prepared Statement of Donna J. Dean, Ph.D., Acting Director, National
Institute of Biomedical Imaging and Bioengineering
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Biomedical
Imaging and Bioengineering (NIBIB) for fiscal year 2002, a sum of
$40,206,000, which reflects an increase of $38,231,000 over the
comparable fiscal year 2001 appropriation.
At the outset, I should note that the NIBIB is the newest of NIH's
Institutes, having been established on December 29, 2000 by Public Law
106-580, the National Institute of Biomedical Imaging and
Bioengineering Establishment Act of 2000. I am excited by the challenge
afforded me to help guide the formation and early development of this
newest member of the NIH family. In the past four months, we have begun
to consider the new opportunities in biomedical research that NIBIB can
foster and have articulated the basic principles upon which we will
build NIBIB. It is my privilege to share with you the philosophy under
which the NIBIB will operate and our initial steps toward fulfilling
the promises embodied in the legislation.
a mission of promise
The foundations of tomorrow's medicine will continue to be built on
the emergence of discoveries in basic science and development of new
technologies. The mission of NIBIB is to apply the principles of
engineering and imaging science to biological systems. Advances in the
imaging sciences could change the face of medicine, making it possible
to non-invasively detect, diagnose, and guide therapy for a large
variety of diseases. Bioengineering is unique in its ability to
integrate principles from diverse fields, and to cross the boundaries
of academia, science, medicine and industry. The focus of NIBIB will be
on developing fundamental new knowledge, creating potent new
technologies, and nurturing researchers to be able to fully integrate
the quantitative sciences with biomedical research.
Bioengineering and the imaging sciences are rooted in physics,
mathematics, chemistry, materials sciences, computer sciences and the
life sciences. The application of these systematic, quantitative, and
integrative ways of thinking about and approaching the solutions to
problems will be important to biology and medical research. The
biological scientist often seeks to answer such questions as ``Why do
things work the way they do?'' and ``How do these organisms function?''
The engineer or imaging scientist may ask questions such as ``How can I
create something that has never existed before?'' or ``Can I develop a
solution to this seemingly intractable problem?'' The excitement of
bringing together new research constituencies, perspectives and
collaborations is a particular challenge and a unique opportunity for
NIBIB.
In support of its mission, NIBIB will support an integrated and
coordinated program of research and research training that can be
applied to a broad spectrum of biological processes, disorders and
diseases and across multiple organ systems. Strong coordination will be
fostered with biomedical imaging and bioengineering programs of other
NIH Institutes and other agencies so as to support imaging and
engineering research with potential medical applications. These
partnerships will facilitate the translation of fundamental discoveries
into research on and applications for specific diseases, disorders, or
biological processes.
Most of the revolutionary changes in biology and medicine over the
past decades were rooted in fundamental discoveries in many different
fields, such as the role of nuclear physics in producing radioisotopes
essential for much of modern medical science. Engineering and physics
were central in the development of key tools of common clinical
practice today--x-rays, computed tomography (CT) scanning, fiber optic
viewing, laser surgery, echocardiography and fetal sonograms. Materials
science is helping to develop new joints, heart valves, and other
tissue mimetics. Understanding of nuclear magnetic resonance and
positron emissions was required for the imaging study of the location
and timing of brain activities that accompany thought, motion,
sensation, speech, or drug use. Now, as never before, the boundaries
are disappearing between biology and biomedical engineering, resulting
in increasing and expanding opportunities for new scientific and
technological approaches and new clinical tools and devices.
identifying productive new research directions
The creation of programs on the cutting edge of research and
innovation will pose complex scientific challenges and require
multidisciplinary strategies. A critical component of the Institute's
inaugural year will be the formulation of a strategic plan for research
in biomedical imaging and bioengineering. This activity will be
undertaken in cooperation with the NIBIB Advisory Council and with
broad representation from the research community. An outstanding
opportunity exists to recruit scientists, engineers and physicians to
new areas of biomedical research through the research programs to be
developed by NIBIB.
NIH has provided important groundwork that is of invaluable aid to
NIBIB as it formulates an emerging research agenda. Key areas of future
research in biomedical imaging and bioengineering have been highlighted
by four symposia sponsored by NIH in the last three and a half years.
At these meetings, the country's leading engineers, scientists, and
physician-scientists have addressed areas of opportunity in
bioengineering, biomedical imaging, nanotechnology, and reparative
medicine or tissue engineering.
Since one of NIH's highest priorities is the funding of medical
research through research project grants, NIBIB will emphasize this
mechanism to promote fundamental discoveries, design and development,
and translation of technological capabilities in biomedical imaging and
bioengineering, enabled by relevant areas of information science,
physics, chemistry, mathematics, materials science, and computer
sciences. The research supported by NIBIB will be multidisciplinary in
nature and strongly synergistic with NIH's other research Institutes
and Centers. NIBIB will expand the principles embodied in NIH's
development of the Bioengineering Research Partnerships and
Bioengineering Research Grants--that creation, development, and
implementation of technology are worthy goals.
developing a new generation of researchers
NIBIB will meet the challenge of training a new generation of
investigators with a vision transcending narrow disciplines. Training
and career development programs will be central to NIBIB's approach to
its mission. Increasing the pool of individuals uniquely positioned to
bring innovative concepts and approaches to research in biomedicine and
health will benefit the entire NIH. The changing nature of biomedical
research in the future points strongly toward the need to train our
young physicians and engineers to succeed in facets of biomedical
research that are not yet imagined.
conclusion
NIBIB's leadership in developing crosscutting research and training
in biomedical imaging and bioengineering will be fostered by strong
partnerships and collaborations with other Institutes and Centers of
NIH, all with the ultimate goal of improvement in human health and
well-being. NIBIB is poised to identify challenges in biomedical
research that can benefit from bioengineering approaches, facilitate
interinstitute cooperation, and promote transdisciplinary training.
NIBIB will strengthen and complement, not substitute for or subtract
from, the already robust research programs of NIH's other Institutes
and Centers. We look forward to the challenges of the next year in
creating a new and enriched focus at NIH for bioengineering and imaging
sciences.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The budget request for fiscal year 2002 for the National Institute
of Biomedical Imaging and Bioengineering is $40.2 million.
Mr. Chairman, I will be happy to answer your questions.
______
Prepared Statement of 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 (FY) 2002. Including
the estimated allocation for the acquired immunodeficiency syndrome
(AIDS) of $1,192,855,000, total support requested for NIAID is
$2,355,325,000, an increase of $292,317,000 over the fiscal year 2001
appropriation. The portion of the budget not related to AIDS is
$1,162,470,000, which reflects an increase of $162,054,000 over the
comparable fiscal year 2001 appropriation. 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 second annual performance report which
compares our fiscal year 2000 results to the goals in our fiscal year
2000 performance plan. As performance trends on research outcomes
emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
overview of niaid
NIAID, the third largest NIH Institute, supports and conducts
research to better understand, treat and prevent infectious,
immunologic, and allergic diseases. The scope of the NIAID research
portfolio is expanding continually in response to new challenges, such
as the emergence of AIDS and other newly recognized diseases, and
because of scientific opportunities facilitated by new technologies and
progress in the core NIAID scientific disciplines of microbiology,
immunology, and infectious diseases. Advances in these key fields,
including progress in relatively new areas such as pathogen and human
genomics, are driving the development of new treatments, vaccines,
diagnostic tests, and technologies that improve the health of people in
the United States and around the world.
In order to meet the many health challenges of the new millennium
and take advantage of unprecedented scientific opportunities, the
Institute has developed a strategic research plan for the 21st century
centered around four major areas: (1) Global health and emerging
infectious diseases; (2) HIV/AIDS; (3) Immune-mediated diseases,
including allergy and asthma; and (4) Vaccines. The complete NIAID
Strategic Plan is available on the World Wide Web at http://
www.niaid.nih.gov/strategicplan2000.
global health and emerging infectious diseases
NIAID has a long history of supporting research into diseases that
transcend national boundaries and hence fall under the rubric of global
health. Examples of such diseases include newly recognized conditions
such as AIDS and liver disease due to hepatitis C virus; diseases that
have spread to new geographical settings, such as West Nile fever and
dengue; and resurgent endemic diseases such as malaria and
tuberculosis, which are increasingly resistant to antimicrobial drugs.
In addition, we now face the specter of a new kind of emerging disease:
one deliberately spread by bioterrorists. These emerging and re-
emerging diseases are superimposed on other major health problems such
as acute respiratory infections, diarrheal diseases, and measles, which
remain leading causes of illness and death worldwide.
To mitigate the burden of these diseases, NIAID supports numerous
laboratory, field-based, and clinical research projects related to
global health, both domestically and abroad. Among many projects,
NIAID-supported studies on malaria in Mali, pneumococcal disease in the
Gambia, tropical diseases in the International Centers for Tropical
Disease Research, and HIV prevention through the HIV Prevention Trials
Network, have achieved important results through coordinated
partnerships with local governments and other agencies and
organizations. Building on NIAID's longstanding commitment in global
health, the Institute this month released a new ``Global Health
Research Plan for HIV/AIDS, Malaria, and Tuberculosis'', which outlines
NIAID goals and plans for fighting infectious diseases by building
sustained research capability domestically and internationally and
enhancing international partnerships.
Many of the challenges posed by emerging infectious diseases lend
themselves to research in a relatively new field: genomics. The
sequencing of the entire human genome and the anticipated assignment,
over the next few years, of function to the estimated 30,000 to 60,000
human genes will have an enormous impact on all of medicine, including
our understanding of the host response to microbial pathogens. In
addition, the genomic sequencing of microbial pathogens will be a
critical component of 21st century strategies for the development of
diagnostics, therapeutics, and vaccines for infectious diseases. NIAID
has funded projects to sequence the genomes of more than 50 medically
important pathogens, a dozen of which have been completed. These
include the bacteria that cause tuberculosis, gonorrhea, chlamydia, and
cholera, as well as individual chromosomes of the malaria parasite,
Plasmodium falciparum. Most recently, investigators have reported the
complete genomic sequence of Streptococcus pyogenes, a bacterium that
causes diseases ranging from strep throat to the flesh eating disease
known as necrotizing fasciitis, as well as that of Escherichia coli
O157:H7, a worldwide public health threat that has triggered scores of
recent outbreaks of hemorrhagic colitis and numerous fatalities from
kidney failure. In the interest of global scientific cooperation,
NIAID-supported scientists deposit pathogen sequence data in
specialized public databases such as GenBank, where investigators
around the world can access it via the World Wide Web.
hiv/aids
AIDS, caused by the human immunodeficiency virus (HIV), has claimed
22 million lives since the disease was recognized 20 years ago. More
than 36 million people are living with HIV infection, including
approximately 800,000 to 900,000 individuals in the United States. In
the United States and other western countries, potent combinations of
anti-HIV drugs (highly active antiretroviral therapy or ``HAART'') have
dramatically reduced the numbers of new AIDS cases and AIDS deaths.
NIAID-supported investigators conducted research that was pivotal to
the development of these drugs, and have helped define how best to use
these medications in different clinical settings. Ongoing research
promises to yield a new generation of drugs that may improve upon
existing medications in terms of cost, effectiveness, and tolerability.
Until recently, expensive HAART regimens were considered to be
beyond the reach of developing countries, where 95 percent of the
world's HIV-infected people live. Now, with dramatic reductions in the
price of antiretroviral drugs for developing nations and the commitment
of world leaders to address the AIDS problem in southern Africa and
other poor regions of the world, AIDS therapies will begin to reach
more of the people in poor countries who could benefit from them.
Building on the research infrastructure that NIAID has helped establish
in Africa and elsewhere in the developing world, we intend to work with
our international colleagues to link the provision of anti-HIV therapy
to ongoing efforts in prevention research, with the goal of
facilitating a comprehensive approach to the AIDS pandemic in poor
countries. Two recently launched NIAID programs will be key to this
effort: the HIV Prevention Trials Network (HPTN) and the HIV Vaccine
Trials Network (HVTN), which have research sites in the United States,
Latin America, Europe, Africa, Asia and the Caribbean.
The HPTN focuses on several key areas of prevention research,
including behavioral modification, interventions to prevent mother-to
infant transmission of HIV, and the development of topically applied
microbicides that women could use to protect themselves against HIV and
other sexually transmitted pathogens. The HVTN will conduct all phases
of clinical vaccine trials, from evaluating candidate vaccines for
safety and the ability to stimulate immune responses, to testing
vaccine efficacy. In pre-clinical and clinical studies, NIAID-supported
investigators are testing a diverse range of vaccine strategies,
several of which in recent months have shown remarkable promise in
tests in non-human primates. The best candidates will be moved rapidly
into HVTN trials. We remain optimistic that a safe and effective
vaccine can be found that will prevent HIV infection and/or slow the
progression of disease in people who are already infected with the
virus.
immune-mediated diseases
Immunologic diseases cause a considerable burden of illness and
death and lead to medical costs that exceed $100 billion annually in
the United States. Many immune-mediated diseases disproportionately
affect women and members of minority groups. Autoimmune diseases such
as type-one diabetes, rheumatoid arthritis, systemic lupus
erythematosus, and multiple sclerosis collectively afflict
approximately five per cent of the U.S. population. More than seven
percent of American children are asthmatic, with poor children in inner
city areas disproportionately affected by this serious disease. In
addition, immune-mediated graft rejection remains a significant
obstacle to the successful transplantation of potentially life-saving
organs.
NIAID-funded research in basic and clinical immunology has led to
many promising approaches for treating individuals with these and other
immunologic conditions. For example, researchers are developing novel
ways of selectively blocking inappropriate or destructive immune
responses, while leaving protective immune responses intact. This
approach, called tolerance induction, holds great promise for the
treatment of many immune-mediated conditions, including autoimmune
diseases and asthma and allergic diseases. The induction of tolerance
to transplanted organs or tissues ultimately may allow transplant
patients to forego long-term regimens of broadly immunosuppressive
drugs. These drug regimens are costly and dampen not only destructive
immune responses, but protective ones as well, thereby increasing a
patient's risk of malignancies and infections. Among many projects in
the field of immune tolerance, the Institute established the Immune
Tolerance Network (ITN), an international consortium of more than 70
research groups. The ITN is implementing clinical trials in four areas:
transplantation of islets (the insulin-producing cells of the
pancreas), kidney transplantation, autoimmune diseases, and asthma and
allergic diseases. The first ITN trial is testing a new approach to
transplanting islets in diabetics who are unable to properly control
their blood sugar levels. This international study builds on
groundbreaking research at the University of Alberta that has resulted
in long-term insulin independence for nearly 20 patients.
For more than a decade, NIAID has worked to reduce the burden of
asthma, particularly among inner-city children. Investigators of
NIAID's National Cooperative Inner-City Asthma Study developed a
successful behavioral and educational intervention that substantially
reduced asthma severity in these pediatric populations. Building on
this success, NIAID and the Centers for Disease Control and Prevention
(CDC) are collaborating to implement this proven intervention in a new
four-year program that will reach 6,000 children in 23 inner-city
health care delivery sites throughout the U.S. An ongoing NIAID
intervention study, involving approximately 1,000 children nationwide,
is testing the effectiveness of environmental control measures and
physician education in reducing the burden of asthma. Preliminary
results are showing substantial reductions in asthma symptoms and
emergency room visits. In both of these studies, recruitment has
exceeded the targeted levels and retention of patients has been
extraordinarily high compared to other studies of other inner-city
pediatric populations. Because of these successes, NIAID-supported
inner-city asthma programs are now recognized as models for conducting
clinical research in the inner city and have attracted partners in the
public and private sectors to collaborate with NIH-funded researchers.
These collaborations promise to bring new asthma interventions to
minority populations whose access to such therapies might otherwise be
diminished or delayed.
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 led to the development of many new and improved vaccines now widely
used, such as those against Haemophilus influenzae type b, pertussis,
chickenpox, pneumococcal disease, and hepatitis A and B. The rapidly
evolving science base in pathogen genomics, immunology and microbiology
will facilitate further progress in developing new and improved
vaccines. In particular, the availability of the genomic sequences of
major microbial pathogens will facilitate the identification of a wide
array of new antigens for vaccines. Because many pathogens gain entry
to the body via mucosal sites, NIAID-supported scientists are
developing new vaccines that target mucosal surfaces such as those in
the intestine or respiratory tract. Vaccines that are easy to
administer--orally, nasally, or trans-dermally--will have great utility
in resource-poor setting and for mass immunization programs. In
addition to the development of vaccines against classic infectious
diseases, NIAID is working to develop vaccines against chronic diseases
with infectious origins, as well as potential agents of bioterrorism,
and autoimmune diseases and other immune-mediated conditions.
conclusion
In the 21st century, NIAID is poised to exploit unprecedented
scientific opportunities in immunology, microbiology and infectious
diseases. As has been the case for more than 50 years, a commitment to
the best possible research--basic science as well as clinical trials--
will drive our efforts to improve health in this country and abroad.
With a strong research base, the commitment of talented investigators,
and the availability of powerful new research tools, we are confident
that our initiatives will help solve seemingly intractable clinical and
public health problems and improve global health in the 21st century.
______
Prepared Statement of Stephen A. Ficca, Associate Director for Research
Services
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the Buildings and Facilities (B&F)
Program for fiscal year 2002, a sum of $306,600,000, which reflects an
increase of $152,810,000 over the comparable fiscal year 2001
appropriation.
role in the research mission
The annual Buildings and Facilities (B&F) Appropriation is the only
means by which the public supports the crucial physical infrastructure
required to carry out the in-house component of the biomedical research
mission of the National Institutes of Health (NIH). As approaches to
basic and clinical research evolve, the demands for, and on, research
facilities change as well. Properly planned and equipped, safe, and
flexible research facilities are important resources in the formula for
achieving the next scientific advance or biomedical breakthrough.
The fiscal year 2002 Buildings and Facilities budget request is the
product of a deliberate, corporate facilities planning process that
addresses the NIH's immediate and longer range facility requirements of
the entire agency. The goal of the planning process is to optimally
meet the changing facility needs of the NIH research programs in the
Washington, D.C., region and across the NIH field stations with a mix
of owned and leased facilities.
The B&F appropriation funds a continuing, multi-year program that
supports NIH facilities throughout their life-cycles. The construction
program supported by the proposed fiscal year 2002 request strikes a
balance among three critical facility priorities: the creation of new
facilities for new and expanding scientific opportunities, the
upgrading of existing facilities to keep pace with the changing
requirements of ongoing NIH programs, and the responsible stewardship
of the entire NIH real estate portfolio. The specific projects included
in the proposed fiscal year 2002 request are on the critical path of a
larger rolling five-year plan. Thus, the investments in fiscal year
2002 are predicated on previous investments and the timely investment
in the future. For example, the Building 6 modernization is the last
project in a series of projects that began in the 1980's to renovate
the original NIH research buildings. The upgrade of the mechanical
system at the National Institute of Environmental Health Sciences is
the first phase of a two-phase modernization of the mechanical and
electrical systems at the Research Triangle, North Carolina, field
station.
Safe, modern facilities, including the appropriate building systems
and utility infrastructure, are a basic requirement to effectively
carry out NIH's intramural research program, as well as stewardship of
the extramural research programs. For the intramural research program,
they are necessary to enable NIH's expansion into new areas of
investigation, to house an expanding cadre of researchers and trainees,
to attract the best and the brightest investigators, and to help retain
staff who are being courted by the burgeoning biomedical industry.
The B&F request for each budget year strives to optimize the
distribution of resources among the programs activities so that, year
to year, the continuity of the individual projects and the B&F Program
as a whole is maintained.. Within this balanced mix of new
construction, essential safety and health improvements, repair and
improvement projects, renovations, and equipment and system upgrades,
three projects are particularly important to the NIH's research plans:
the John Edward Porter Neuroscience Research Center, the Central
Vivarium/Animal Research Center, and the Building 10 Revitalization
Program.
The John Edward Porter Neuroscience Research Center will enable the
integration of the neuroscience research community at the NIH. The
Center is conceived as a place where the best and brightest scientists
from many disciplines will collaborate in state-of-the-art laboratories
to develop and evaluate therapies for some of the most complex problems
in biomedical research. The Center will house researchers from nine
institutes and multiple disciplines under one roof. It will be designed
to support high priority research initiatives using innovative
strategies in cell biology, neuroimaging and bio-informatics to better
describe the link between biochemistry and behavior, to elucidate the
nerve cell degenerative processes, and to explore other lines of
inquiry that are emerging from the genetic mapping of the brain.
New facilities are needed to support this vision because nearly all
of the space that houses NIH neuroscience research is substandard.
Current facilities for cellular and molecular neuroscience on campus
are inadequate to meet the challenges of high-quality, high-risk
research projects.
The Central Vivarium/Animal Research Center is a vital part of the
NIH research infrastructure. Animal models continue to be one of the
most valuable means of elucidating basic biology and more complex
mechanisms of disease. The multi-level facility will include state-of-
the-art animal holding, receiving and quarantine areas; procedures and
specialized laboratories and administrative support spaces. It will
replace facilities that are crowded and only marginally suitable to the
support of many of the most promising animal models with AAALAC-
compliant facilities specifically designed to humanely house non-
mammalian species, genetically altered rodents, chimeras, and non-human
primates.
The soon to be completed Mark O. Hatfield Clinical Research Center
(CRC) will be one major milestone in a continuing effort to maintain
the physical research infrastructure of the Agency. It will house
state-of-the-art patient-related research and laboratory research
facilities for the clinical programs. The Building 10 Revitalization
Program is the next phase in the renaissance of the critical
infrastructure for the clinical research program at the NIH described
in the 1994 Marks-Cassell report. The Building 10 Revitalization
Program is a multi-phased approach that will renovate and renew the
portions of the clinical program that remain in Building 10 when the
CRC is occupied. The purpose of this effort when completed, is to
accommodate all the research programs in the entire Clinical Center
Complex in modern, safe, state-of-the-art hospital, research and
support facilities. The fiscal year 2002 request for the Building 10
Revitalization Program consists of three program activities. The
Building 10 Transition Program includes projects required to sustain
functionality between the old and new buildings. The Building 10
Interim Renovation provides the necessary space and infrastructure
reconfiguration to allow continued operation of the building during the
phased renewal. Finally, the Phase I Renovation of Building 10 includes
the renovation of the central core as clinical research space and the
renovation and interconnections of the hospital and facilities support
systems between the buildings.
fiscal year 2002 budget summary
As in prior and future years, the funding request for fiscal year
2002 is a part of a long range plan. The fiscal year 2002 request for
Buildings and Facilities is $306.6 million. The B&F request totals
$105.1 million for new construction composed of $26 million for the
continued construction of the John E. Porter Neuroscience Research
Center; $10.6 million to fund the design of the second phase of the
Center; $53 million to complete the design and start the construction
of the Central Vivarium/Animal Research Center; $14 million to design
and construct the Northwest Parking Facility; and $1.5 million to
initiate the Concept Development Studies program. There is a total of
$99.9 million for essential safety and health improvements composed of
a combined sum of $36 million to begin the Building 10 Revitalization
Program through a plan of Interim Renovations to provide temporary
space, and the initiation of the Phase I Renovation; $19.7 million in
funding to complete the modernization of Building 6; $10 million for
the continued support of the rehabilitation of animal research
facilities; $10 million for the continuing upgrade of fire and life
safety deficiencies of NIH buildings; $3 million for the phased removal
of asbestos from NIH buildings; $1 million to systematically remove
existing barriers, to persons with disabilities, from the interior of
NIH buildings; $2 million to address indoor air quality concerns and
requirements at NIH facilities; $12.2 million as a second phase to
improve and upgrade utilities at the NIH Animal Center; $7.2 million to
replace the mechanical systems in Building 6B; $5 million to initiate a
four-year program to upgrade elevators in various buildings on the
Bethesda and satellite campuses; and $1 million to allow for
environmental remediation activities at NIH sites. In addition, the
fiscal year 2002 request includes $65 million for the continuing
program of repairs, improvements, and maintenance that is the core of
the B&F program. The fiscal year 2002 request also includes: $14.1
million for the Building 10 transition program; $3.6 million to upgrade
mechanical systems at NIEHS; and $11.7 million to complete the
construction and installation of Boiler 7 on the NIH campus in
Bethesda.
government performance and results act (gpra)
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Enoch Gordis, M.D. Director, National Institute
on Alcohol Abuse and Alcoholism
I am pleased to present the President's budget request for the
National Institute on Alcohol Abuse and Alcoholism (NIAAA) for fiscal
year 2002, a sum of $381,966,000, which reflects an increase of
$41,288,000 over the comparable fiscal year 2001 appropriation.
Alcohol-use disorders impose an enormous toll on society. They cost
the Nation $185 billion each year, one-and-one-half times as much as
all illegal drugs combined,\1\ and 100,000 people die of alcohol-
related causes annually.\2\ These figures reflect only the toll imposed
by the 14 million adult Americans who are physically dependent on
alcohol or who abuse it to the point that it disrupts their lives, but
who aren't dependent on it.\2\ Still others add to the burden when they
occasionally drink to excess and, temporarily impaired, injure or kill
themselves or others, or damage property.
---------------------------------------------------------------------------
\1\ Updated figures from Lewin Group, 1998.
\2\ IAAA epidemiology data.
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alcohol is unique
Among substances of abuse, alcohol is unique in a number of ways.
It is a toxin that can cause damage to any tissue in the body. The
resulting diseases range from certain kinds of cancer to liver and
heart disease. Alcohol also is unique in the pervasiveness of its
actions in the nervous system, the body's command center, through which
alcohol exerts its behavioral effects. Rather than affecting only one
or a few neurotransmitter systems--that is, the crucial chemical
systems through which components of the nervous system communicate with
each other and with the outside world--alcohol affects every
neurotransmitter system that we have studied to date.
Alcohol also affects parts of the membrane that surrounds nerve
cells, the ``point of entry'' for substances of abuse, that illegal
drugs do not appear to affect. These factors greatly complicate the
search for alcohol's sites of action in the nervous system.
Policy and legal issues--as well as social ones--also confer unique
status on alcohol. For example, alcohol raises the need for laws on
minimum drinking age, maximum allowable blood levels for driving, and
zoning and licensing. Alcohol raises the issue of revenue, since it is
associated with a tax-paying industry, an industry that promotes
alcohol's use through advertising. Alcohol also raises the issue of
warning labels on beverage containers.
Another of the ways in which alcohol is unique among substances of
abuse is that it is a food, since it has caloric value. The brain
regulates appetite for food through neuropeptides, pieces of protein.
Evidence suggests that, to some extent, craving for alcohol might be
driven by the same or similar biochemical pathways that drive appetite
for food.
neuroscience holds the key to behaviors of alcoholism
Some people can drink lightly and occasionally and never develop
problems with alcohol, while at the opposite end of the spectrum of
alcohol use, it takes over people's lives and they become physically
dependent on it. Between these two scenarios lie varying degrees of use
and misuse. What accounts for these differences in how people respond
to alcohol, differences that may decide whether or not it destroys
their lives?
Environmental factors--family and peers, for example--play a role,
but variations in our nervous systems constitute the largest part of
the differences in our behaviors toward alcohol. It is here that
alcohol affects a multitude of biologic events that determine our
propensity for drinking and our vulnerability to the biologic process
of becoming dependent on alcohol. Before we have taken our first drink,
the genetic and molecular make-up of our brains influences, largely,
how we will respond to alcohol once we are exposed to it.
Substances ultimately stimulate the same major reward pathways of
the brain. However, various substances first stimulate other, different
biochemical pathways before they ``light up'' these major reward
pathways. Thus, substances differ in the mechanisms, and in the
complexity of those mechanisms, that lead to reward. The routes of
alcohol's actions appear to be particularly pervasive.
Alcohol's effects on the nervous system vary throughout the life-
span, from the uniquely devastating damage it causes in the fetus, to
disruptions in development of the adolescent brain, to the patterns of
biologic risk and damage we see in adults. Among substances of abuse,
alcohol is, by far, the greatest inducer of neurologic and other birth
defects.
the answers we seek
Alcohol research seeks to answer these questions: What are the
genetic and molecular factors in the brain that determine these
differences in how we respond to alcohol? How does alcohol change
``hardwired'' functions of the brain to cause physical dependence? What
role do environmental factors play in alcohol dependence? Can we design
interventions that disrupt these biologic and environmental pathways,
to prevent alcohol's harmful effects? In each of these areas and
others, we are making advances.
advances in alcohol research
Our neuroscience research is aimed at understanding how a multitude
of biologic factors combine to form neural circuits--networks of nerve
cells and the thousands of biochemical activities associated with
them--that mediate alcohol's actions. Our research links these biologic
events with alcohol-related behaviors and the impact that environmental
influences have on them.
We have made major advances. For example, we are closing in on
specific regions of the nerve-cell membrane where alcohol initiates its
effects. This kind of information raises possibilities for design of
medications that block such sites. Among our priorities is to develop
medications that will be effective in a wider range of people with
alcoholism than are current medications. For example, our research on a
nervous-system protein (protein kinase C) has resulted in a
treatment-development project by a pharmaceutical company.
Animal and clinical neuroscience findings are guiding our efforts
to develop medications for alcoholism that target optimal molecular
sites in the nervous system. For example, naltrexone, approved for
alcoholism treatment by the FDA in recent years, targets a specific
neurotransmitter system--the opioid system--and is among the more
promising pharmaceuticals currently in use.
In the genetics arena, we have found several chromosomal regions
likely to contain genes that influence our susceptibility to
alcoholism. Our challenge is to pinpoint their exact locations. Because
alcoholism is a genetically complex disease--that is, multiple genes
influence it--the search for these genes is complex. Our Collaborative
Study on the Genetics of Alcoholism addresses this issue and has
generated data used by other disciplines with an interest in addiction
and by the scientific community.
We are conducting studies in rodents in which we either ``knock
out'' or enhance the activities of genes, to see how this affects
behaviors toward alcohol. These studies are providing us with
information about biologic mechanisms that contribute to the risk of
becoming alcoholic. Another genetics technology (microarray technology)
is telling us which genes appear to be active under various scenarios
of alcohol use. This technology enables us to scan much of the human
genome for changes in gene activity that occur with physiologic states
associated with alcohol; for example, alcohol dependence.
Our research is revealing mechanisms that mediate alcohol's damage
to the fetus and evidence that adolescent brains are vulnerable to
alcohol-induced damage. New NIAAA research also links stress-induced
hormonal changes in infancy with risk of alcohol problems later in
life.
Ultimately, these kinds of studies can guide us to points for
pharmaceutical intervention in the biochemical pathways through which
alcohol exerts its effects. We are capturing the potential of
neuroscience through collaboration. Alcohol research covers the
spectrum from genetics to behavior and all of the intricate molecular
biology that lies between. However, so many areas of expertise now
exist in neuroscience that integrating research and results relevant to
alcohol investigations is difficult. To ensure that we do not miss
opportunities, our Integrative Neuroscience Initiative on Alcoholism is
encouraging investigators from different fields to integrate their work
and their findings. We expect this major initiative to speed the
translation of new findings into clinically useful data.
beyond basic science
Our research on social and policy issues extend far beyond
questions of legislation. For example, drinking among college students
is a complex problem entrenched in campuses and communities. Evidence
suggests that intentional and unintentional injury, including death,
associated with this problem is much greater than previously suspected.
Our investigators are pursuing estimates of alcohol-related death rates
among this vulnerable age group, and avenues for prevention. Minority
groups provide another example. Certain minority groups appear to
respond differently to alcohol, physically and behaviorally, than does
the general population. Our epidemiology research identifies these
kinds of public-health issues, and these findings lead to basic and
behavioral research that investigates root causes and potential
interventions.
We bring our research findings to the public in a variety of ways.
Our Research to Practice Initiative is an excellent example. In
collaboration with the Substance Abuse and Mental Health Services
Administration's Center for Substance Abuse Treatment, we arrange with
States to meet with treatment providers and administrators. After
exchanging information about our current research findings and the
practitioners' obstacles to providing treatment, we place experts in
temporary residencies in treatment programs that have identified
specific areas of need.
We bring our findings to the public via Alcohol Screening Day, a
nationwide event that enables people to receive free screening for
alcohol problems and, if needed, referrals. Last year, almost 1,500
sites across the country participated, more than 370 of them college
campuses. We also are dealing with the difficult issue of college
drinking through our Advisory Council's Subcommittee on College
Drinking. The Subcommittee, a collaboration between researchers and
college presidents, has been meeting since 1998 and has commissioned
major papers and panel reports to guide efforts to prevent drinking by
students.
Drinking by youth is not limited to college students, and we are
reaching children and adolescents through our Governors' Spouses
Initiative. Spouses of governors in 28 States have joined this project
to reduce drinking by young people; a crucial effort, given our
findings that early initiation of drinking portends dramatically higher
risk of alcoholism later in life. These efforts will be accompanied by
public service announcements on underage drinking.
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 second annual performance
report, which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
______
Prepared Statement of Dr. Patricia A. Grady, Director, National
Institute of Nursing Research
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Nursing
Research (NINR) for fiscal year 2002, a sum of $117,686,000, which
reflects an increase of $12,508,000 over the comparable fiscal year
2001 appropriation.
This year, as NINR celebrates its 15th anniversary, it is
encouraging to reflect on the progress made so far. Nursing research on
a broad range of issues has been stimulated, developed, funded,
published, and integrated into practice, where patients and the public
are already reaping the benefits of improved health care. Studies
include improving management of symptoms and quality of life for the
increasing population of patients with longstanding chronic illnesses;
smoothing the transition of advanced technologies into people's lives,
such as genetic screening and telehealth; reducing health disparities
among minorities and those without adequate access to the healthcare
system; and improving care at the end of life. Yet nursing research is
a young science. It must continue to grow to help meet urgent national
health needs, expectations of our nation's people, and requirements of
2.7 million registered nurses for well-tested, effective interventions.
NINR research is central in supplying empirical evidence that expands
the scientific base for care affecting people's physical, psychosocial,
and cultural needs.
translating research findings into practice at the community level
Let me illustrate how nursing research can influence public and
private organizations at the community level--and in so doing, help
eliminate health disparities. NINR study findings addressed an
important health issue--low birthweight and preterm births--and
supported research that promoted lower incidence while decreasing costs
to the healthcare system. According to the National Center for Health
Statistics, the United States is a disappointing 26th among
industrialized nations in the number of babies per 1000 dying before
their first birthday. The national rate is over 7 deaths per thousand.
For African-Americans it is over 14 per thousand. In North Carolina,
where the study took place, investigators targeted low-income African
American pregnant women and Caucasian women at particular risk for low
birthweight, including pregnant teens. This five-year project involved
a home visit followed by low-cost, low-tech phone calls by registered
nurses to monitor health and address problems of the women. Results
showed that the low birthweight rate for the treatment group was 10.9
percent, compared with 14 percent for controls. For African Americans
19 years and older, the results were even more pronounced--11 percent
in the treatment group versus 17 percent for controls. For this group,
cost savings to the hospital were $277 per pregnancy. Extended savings
also resulted from a reduction in long-term problems related to low-
birthweight.
Investigators expanded the intervention to four programs that
included Hispanics, African-Americans and Caucasians--three programs
focusing on low-income women and one on women of all income levels
nationwide. The results equaled or bettered the original study
findings. All four programs are continuing today without Federal
research funding--having been adopted by private sector organizations,
including a national HMO.
improving daily living for alzheimer's disease patients
This anniversary year presents the opportunity to recognize some
notable nursing science advances. For example, with respect to
Alzheimer's disease patients, an important goal is preserving their
functional capacity as long as possible so that they can bathe, dress
and feed themselves. Researchers studied nursing home residents with
Alzheimer's disease--the most disabled group in these establishments.
Their disabilities were found to be caused by cognitive deficits, but
also by the staff's inability to encourage independence. This can cause
disability beyond what can be expected of cognitive impairment alone.
The study involved nursing home staff instituting one-to-one
interventions to improve the residents' abilities to bathe and dress.
First, the residents were examined to determine which skills they
retained. Then the physical and social environment was restructured to
reactivate those skills. Findings indicate that the intervention
improved residents' bathing and particularly dressing capabilities, and
disruptive behaviors were reduced. Improvements were realized within
five days' time and were maintained by the end of three weeks. To
achieve this, however, staff time with each resident increased.
Investigators hypothesize that the amount of time can be reduced if the
goal is to maintain the residents' skill levels, rather than to raise
them.
end-of-life/palliative care research
Another issue predominantly affecting seniors, but also affecting
people of all ages, is how to retain quality of living during life's
final phase. NINR has a special interest in this area and is the
Institute that coordinates end-of-life research at the NIH. A major
issue is that, while capable of enhancing life, technologies and
treatments can also involve burdensome procedures that may be futile
and prolong discomfort and pain. The decision whether or not to
withdraw life support, usually made by family members or friends on
behalf of the dying patient, is a difficult decision to make. NINR
researchers measured family member stress levels and found them to be
twice as high as those due to other serious crises, such as
construction disasters, or losing a home to fire. This study is one of
the first to show that existence of an advance directive eases stress
on the family when life-sustaining treatment is withdrawn. When an
advance directive existed to guide decisions, the families were better
able to focus on patients' quality of life and less likely to choose
prolonging life at all costs.
factors influencing obesity in adolescents
Obesity can decrease quality of life and shorten life span.
According to the Centers for Disease Control and Prevention, 13 percent
of children and 14 percent of adolescents are overweight, continuing
the pattern of the past two decades. These young people are at risk for
cardiovascular disease later in life. In a study of 2000 adolescents, a
nurse investigator found that for both males and females, the influence
on obesity of ethnicity and socioeconomic status was greater than the
influence of watching TV or playing video games. African-American teens
and low-income female teens were at special risk, which suggests where
the emphases of prevention programs should be placed. The study also
indicated that participation in high-intensity exercises, such as
basketball or swimming, may protect boys against obesity. School
physical education and community recreation programs that feature high-
intensity physical activities could help lower the obesity rate.
Further research is needed, however, before programs can be developed
for girls.
new and expanded initiatives
Turning to the immediate future, next year NINR plans an increased
emphasis on chronic illness. The rise in chronic illness creates an
escalating demand for strategies that enable people to live as normal
lives as possible, even while they are dealing with chronic illness.
Another key factor is caregiving for family members at home. This
practice is increasing in importance as an essential ingredient of the
Nation's healthcare system.
The chronic disease of cancer has special urgency for minorities,
because it is they who bear an unequal burden for this disease. The
Healthy People 2010 report states that African Americans are 34 percent
more likely to die of cancer than are Caucasians. New ways must be
found to reverse this disturbing trend. NINR plans to concentrate on
culturally-sensitive prevention research that focuses on lifestyle
factors, such as alcohol, poor diet, and exposure to environmental
toxins. We will also develop and test innovative approaches to increase
screening for cancers in minorities, which should help reduce disease
or bring balance to the present unevenness of disease expression among
populations.
Chronic pain, prevalent throughout our society, is frequently the
reason people visit doctors and hospitals, and it can significantly
influence recovery from illness. Imagine, however, being in severe pain
but not able to tell the nurse or doctor about it. Many people are in
this position, which makes pain treatment all the more difficult.
Examples include those who may be cognitively impaired, or cannot speak
English, or are infants unable to talk yet. Next year NINR plans a new
emphasis on pain. Researchers must discover cues that indicate the
presence and degree of pain so that adequate treatment can be provided
for those who cannot speak for themselves. Research is also needed to
address other barriers to the effective treatment of chronic pain,
including under-reporting of pain and underutilization of analgesics.
Frequently accompanying chronic illness is cachexia, a condition
signaled by muscle wasting and weight loss. Patients with cancer,
cystic fibrosis, AIDS, and chronic lung disease are at risk for
cachexia. The impact on quality of life stems from fatigue, weakness
and susceptibility to other complications. Despite promising
opportunities, there has been limited research attention to this
condition. The urgent needs of patients with long-standing illnesses
dictate that cachexia must be addressed.
Those who care for ill family members are sometimes overlooked in
the overall battle against chronic illness. Yet according to the Center
for Advancement of Health, nearly one in four families in our country
are involved not only with physical care of their relatives, but also
in dealing with behavioral or cognitive problems. Yet many caregivers
must still shoulder their other responsibilities of daily life. The
combination of these demands can put them at risk for poor health,
caused in part by the stress of caregiving and perhaps their own
advanced years. NINR plans to increase research in this area, including
studies to promote learning and refining caregiving skills to benefit
the patient, and strategies to safeguard caregivers' own health and
quality of life.
building the capacity to do nursing research
NINR must also ensure that the nation maintains a sufficient, well-
prepared supply of nurse researchers to provide the empirical evidence
necessary for clinical nursing practice. NINR offers a variety of NIH
training opportunities, including those emphasizing patient-oriented
research and research conducted by and involving minorities. We must
also address the concerns of the recent report of the National Research
Council on the needs for biomedical and behavioral scientists. The
report recommended that NINR emphasize research training that
facilitates earlier entry into research careers. To address this
concern, NINR has designed several innovative programs to attract
students to early research careers and to shorten the entry time into
research. We also plan to continue our successful Summer Genetics
Institute to fill the need for expert nurses prepared to address the
many issues raised by genetic advances.
In closing, contemporary and future biomedical and behavioral
research will continue to emphasize many aspects of what nurses do
well--such as ethnic and culturally sensitive approaches, health
promotion, and symptom management--all strong research emphases of
NINR. NINR must continue to build good science in these critical areas.
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 second annual performance
report which compared our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
I would be pleased to answer any questions the Committee may have.
______
Prepared Statement of Richard J. Hodes
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute on Aging
(NIA) for fiscal year 2002, a sum of $879,961,000, which reflects an
increase of $93,509,000 over the comparable fiscal year 2001
appropriation. 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 second
annual performance report which compares our fiscal year 2000 results
to the goals in our fiscal year 2000 performance plan. As performance
trends on research outcomes emerge, the GPRA data will help NIH to
identify strategies and objectives to continuously improve its
programs.
Evidence suggests that older Americans are living longer, healthier
lives. Life expectancy in the United States has dramatically improved
from an average of 49 years in 1900 to 76 years at the turn of the 21st
century.\1\ The results of several national surveys also suggest that
older Americans are experiencing better health and a declining rate of
disability. Despite this promising news, we know that good health is
not a universal reality for all older Americans -especially for aging
minority groups. Thus, the NIA is committed to supporting high quality
research to address the conditions and diseases affecting the elderly
population, such as Alzheimer's disease (AD), osteoporosis,
cardiovascular disease, cancer, diabetes, and physical frailty.
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\1\ National Center for Health Statistics, National Vital
Statistics Report, United States Life Tables, 1998, February 2001.
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conquering alzheimer's disease
AD, the most common cause of dementia among older persons,
tragically affects as many as four million Americans who are
predominately 65 years and older. There has been an explosion of recent
findings that are yielding important clues about AD risk factors and
disease pathology and, as a result, are suggesting targets for
treatment and prevention.
In the past year, scientists have identified a number of genetic
and non-genetic AD risk factors. Separate studies concluded that a gene
or genes on chromosome 10 may be risk factors for late onset AD-the
most common form of AD. Prior to these findings, the apolipoprotein E
(APOE) gene was the only widely recognized genetic risk factor in late
onset AD. Examples of possible non-genetic risk factors uncovered
recently include poor socioeconomic status, low-educational level,
absence of extensive social networks, and history of serious head
trauma. Evidence from these and other studies suggests that early life
course events may play a role in AD development and could lead to novel
interventions.
While research is ongoing to explain how AD develops, scientists
are also working to translate information about risk factors and
underlying disease mechanisms into effective AD treatments. The public
and scientific community are particularly excited about an emerging,
potentially promising AD vaccine. In a breakthrough experiment last
year, which was based upon NIH-supported advances in basic research,
pharmaceutical company scientists announced they had developed a
vaccine that in mice appears to slow production of amyloid. Amyloid is
the substance, or peptide, that forms the senile plaques in the brains
of AD patients. Their research showed that repeated long-term
injections of an amyloid vaccine can stimulate an immune response in
test mice, nearly eliminating amyloid plaques and associated
neuropathology. (Chart#1) A number of NIH-funded scientists have since
confirmed and extended these observations. Other NIA-supported studies
have shown that the vaccine is effective in preventing cognitive
decline in mice. Human trials being conducted by pharmaceutical company
researchers are now beginning to test both the safety and efficacy of
these vaccines as a possible therapy for AD. The NIA is discussing
potential ways in which the public and private sectors can collaborate
to facilitate the success of these critical trials.
The NIA is currently supporting 17 AD clinical trials, seven of
which are large-scale cognitive impairment and AD prevention trials.
These trials are testing agents, such as estrogen, anti-inflammatory
drugs, and anti-oxidants, for their effects on slowing progress of the
disease, delaying AD's onset, or preventing the disease altogether.
Other intervention trials being supported by the Institute are
assessing the effects of various compounds on the behavioral symptoms
(agitation, aggression and sleep disorders) in people with AD. The NIA
is also supporting studies that are testing interventions for improving
AD patient care delivery and alleviating caregiver burden.
reducing disease and disability
Besides AD, many other chronic diseases and disabling conditions
can compromise the quality of life for older people. Osteoporosis, a
skeletal disorder characterized by compromised bone strength, is one of
the seven most common causes of disability in older people, especially
older women. According to the National Institute of Arthritis and
Musuloskeletal and Skin Diseases, one out of every two women (as
opposed to one in eight men) over 50 will have an osteoporosis-related
fracture in her lifetime. Large observational studies have determined
that the use of thiazide diuretics, an inexpensive treatment for high
blood pressure, is associated with higher bone density and about a 30
percent lower risk of hip fracture. To directly test the effects of
low-dose hydrochlorothiazide on bone density in men and women with
normal blood pressure, investigators completed a recent clinical trial.
The trial found that the agent preserved bone density at the hip and
spine. The modest effects observed over three years, if accumulated
over 10-20 years, may explain the 30 percent reduction in hip fracture
risk associated with thiazides in the earlier observational studies.
The results of this trial suggest that low-dose thiazide therapy may
have a role in preventing osteoporosis.
Diabetes is another one of the seven major debilitating diseases
affecting older people. Adult onset diabetes, or type 2 diabetes
mellitus (DM), is caused by an inability of the beta cells of the
pancreas to compensate for increasing insulin demands; consequently,
blood glucose levels rise. GLP-1, a glucagon-like gut peptide, can
stimulate beta cells to produce more insulin even in type 2 DM;
however, its biologic half-life is short and its effects quickly
diminish. Exendin-4, a newly studied peptide analog of GLP-1, is long-
lived and more potent than GLP-1, and has been shown to reduce blood
glucose levels in rodents. A recent study with small numbers of
diabetic and non-diabetic humans demonstrated Exendin-4's efficacy in
inducing insulin and normalizing blood sugar, even in diabetics.
(Chart#2) In the near future, an exendin-like drug possibly may become
an effective treatment for type 2 DM.
Research has shown that many of the disabling conditions affecting
older people could be diminished through regular exercise. The evidence
was enhanced this year by findings that found fitness affects mortality
risk regardless of an individual's body fat. One study, which followed
men 30-83 years of age for an average of eight years, found that within
each category of body fatness,''fit'' men (as measured by exercise
testing) were at a lower risk of death. In addition, among fit men,
obesity was not significantly related to risk of death. In another
study, low fitness increased mortality risk in men approximately
fivefold for cardiovascular disease and threefold for all-cause
mortality. Low fitness was associated with higher mortality in all
weight groups. Findings like these motivate the NIA to continue its
ongoing campaign to encourage older people to exercise. Since the
campaign was launched in 1998, the NIA has distributed over 350,000
copies of its exercise guide and over 15,000 copies of its companion
video to the public.
biology of aging
In keeping with its mission, the NIA supports research on diseases
and conditions affecting the elderly as well as on the normal aging
process. To understand the aging process, it is important to identify
those factors that affect the overall life span of an organism. Toward
this end, NIA supports and promotes research on the biochemical,
genetic, and physiological mechanisms of aging and the onset of age-
related disease. Experiments in a number of animal models, such as
mice, fruit flies, and nematodes (roundworms), are providing valuable
insights.
Understanding factors that contribute to longevity in animal
models, and how these factors may apply to humans, are of major
interest to the NIA. The role that oxidative stress, for example, may
play in the aging process continues to be explored. In the last year,
investigators announced that they had extended the average life span of
nematodes via pharmacological intervention targeting oxidative stress.
Using an artificial compound, EUK-134, which mimics enzymes that reduce
oxidative damage, researchers extended the life span of nematodes by
about 50 percent. The intervention also reversed premature aging in a
nematode strain subject to elevated damage. These results strongly
suggest that oxidative stress is a major factor in the rate of aging in
the nematode and may be slowed by pharmacological intervention. It may
be that similar compounds could lessen oxidative stress in humans and
delay or reduce age-related pathology.
Caloric restriction, which entails a diet that includes all of the
necessary nutrients but fewer calories, has been shown to slow the
intrinsic rate of aging and to delay and reduce the onset of diseases,
such as cancer. In rodents, it was demonstrated recently that caloric
restriction can also increase resistance of neurons to age-related and
disease-specific stresses, suggesting that it may be an effective
approach for reducing neuronal damage and neurodegenerative disorders
in aging. Although the effects of caloric restriction on humans have
not been evaluated, this year, the NIA announced an initiative to begin
studying the effects in humans of sustained caloric restriction on
physiology, metabolism, body composition, risk factors for age-related
pathologies, progression of age-related changes (where feasible), and
its potential adverse effects. Results of these studies could be
valuable in the development of better methods of preventing multiple
age-related diseases.
behavioral and social research
Behavioral and lifestyle factors have a profound impact on health
throughout the life span. Thus, the NIA supports behavioral and social
research, including demographic research, to elicit information about
the health of older people, their socioeconomic status and the social
and behavioral influences that affect their lives.
Demographers reported some of the most promising news of the last
decade related to the health status of older Americans. In a landmark
study, researchers used the 1982 disability rates from the National
Long Term Care Survey (NLTCS) for people aged 65 and older to estimate
the numbers of disabled persons in each future year using census bureau
projections. They then used subsequent waves of the NLTCS to determine
the actual numbers of disabled persons and compared that to their
estimates. Using this method, they observed 1.6 million fewer disabled
older people in the U.S. in 1998 than there would have been if the
disability rate had not changed since 1982.\2\ (Chart #3) These
decreases in disability have been confirmed using several independent
databases and have been shown to benefit both men and women, and
minority as well as non-minority populations. The latest preliminary
findings from the 1999 NLTCS suggest that the rate of decline in
chronic disability is continuing and may even be accelerating. Research
is ongoing to understand the potentially significant long-term economic
and social consequences of disability decline, including its effect on
health care costs and the American workforce. Importantly, research has
also begun to identify the factors contributing to the decline so that
specific interventions and behavioral changes can be designed that
might sustain or accelerate trends in improved function and quality of
life among older Americans.
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\2\ National Long Term Care Survey 1982-1994 (Kenneth Manton,
Ph.D.)
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NIA encourages research with the aim of not only extending life,
but also improving the quality of life. One factor contributing to a
higher quality of life in later years may be a positive outlook. A
recent study demonstrated that emotional vitality is associated with
decreased mortality and is correlated with slower progression of
disability in disabled older women (aged 65 years and older). Using
data from the Women's Health and Aging Study, a longitudinal study of
disabled women, researchers found that women who were classified as
emotionally vital (i.e. upbeat and positive) at the beginning of the
study maintained better physical function over time than women who were
not emotionally vital. Although more research is necessary to elucidate
the possible role of emotions in protecting against health decline,
these results suggest that helping older people maintain a high level
of emotional vitality may help prevent or slow physical decline.
conclusion
Many people have assumed that old age is always associated with
increased disability. As little as five years ago, researchers could
not conceive of an approach to preventing Alzheimer's disease (AD).
However, through research advances, the nation has renewed hope that
scourges, like AD, may be treated or prevented one day. Americans can
also foresee the possibility of living a long, satisfying life free of
major disability. To continue its trajectory of recent success, the NIA
recently released its five-year strategic plans for aging research and
research into health disparities. The goals are ambitious. However,
these documents provide a framework that the Institute will be using to
continue the tremendous progress made in the last century. By
continuing and intensifying research, NIA can move forward in meeting
the promise of extended life by improving the health and well-being of
older people in America.
______
Prepared Statement of Steven E. Hyman, M.D., Director, National
Institute of Mental Health
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 2002, a sum of $1,238,305,000, which
reflects an increase of $131,576,000 over the comparable fiscal year
2001 appropriation.
mental disorders are enormously disabling
Mr. Chairman, mental disorders constitute extraordinarily
significant causes of disease burden in the United States and
worldwide, with their greatest contribution to that burden resulting
from their disproportionate impact on disability. According to the
World Health Organization (WHO), major depression is the leading cause
of disability in the United States and, indeed, throughout the
developed world, and four mental illnesses rank among the top ten
causes of disability. In recognition of this fact, the WHO has
designated mental health as the topic of the World Health Assembly to
be held in May in Geneva, which will be attended by Secretary Thompson
and health ministers from all member nations within the U.N. In
addition, mental health will be the sole topic of WHO's World Health
Report for 2001, which should provide a significant platform for
improved understanding worldwide. The World Health Report will
complement the extremely well-received Surgeon General's Report on
Mental Health issued by Surgeon General David Satcher in December 1999
in the United States. The NIMH takes great pride in having served as
the critical advisor to both the United States and World reports.
co-occurring mental and general medical disorders
The impact of mental illness on disability is well known. Less well
known, but increasingly well documented, is the fact that mental
illness can have a significant impact on the incidence and course of
general medical disorders. In March, NIMH sponsored a conference in
Pittsburgh that was attended by a member of this panel, Congressman
Kennedy, and a member of the Senate, Senator Arlen Specter, which
focused on this issue of co-occurrence, or comorbidity. Scientists
presented overwhelming evidence for a physiologic role of depression in
the progression of heart disease, including a contribution to heart
attacks and death. Of course, depression may interfere with a person's
ability to engage in rehabilitation or to adhere to diets and complex
medical regimens. But that is far from the whole story. Depression
causes excessive release of stress hormones, such as cortisol and
adrenaline that can have negative effects on metabolism and on the
heart. Depression may also make the heart more prone to abnormal
rhythms, and may alter the stickiness of platelets. There is strong
evidence that the fundamental pathologic processes leading to
Parkinson's disease often also lead to severe depression, which, in
turn, can markedly exacerbate this disabling and tragic disorder. And
research points to the role of depression as a contributor to mortality
in cancer and AIDS. Some treatments for general medical illnesses may
also cause depression by altering brain chemistry. Treatment of cancer
with high dose interferon--is often limited--indeed, often terminated--
as a result of interferon-induced depression. Early treatment with
antidepressant medication was shown this year to minimize depression
and facilitate cancer treatment. Separation of ``mind'' and ``body'' in
medicine is folly. Mental disorders are illnesses of the brain. By
themselves these disorders cause enormous suffering and disability, but
in addition, by altering hormone release, appetite, sleep, and other
somatic systems, mental illnesses have a deleterious--and often
preventable--impact on organs outside the brain.
strategic research planning targets mood disorders
The conference on depression co-occurring with other medical
illnesses was held in conjunction with an exciting effort to engage the
Nation's leading mood disorder researchers in our ongoing strategic
planning process. The effort, entitled ``Breaking Ground, Breaking
Through: A Strategic Plan for Depression and Bipolar Disorder
Research,'' will identify scientific areas that offer significant
opportunities for progress or in which there are currently significant
gaps. Participants analyzed the state-of-the-science in nine areas,
ranging from genetics, to the neural and behavioral substrates of mood
regulation, to an assessment of barriers to care for patients at all
points across the lifespan and in all of our racial and ethnic minority
groups. These reports will be published in a leading scientific journal
later this summer, and will provide the grist for updates to our NIMH
Strategic Plan. This plan, which is publicly discussed by our National
Advisory Council on a regular basis, plays a critical role in our
engagement with the scientific community as well as with other
stakeholders. We believe that accountability to the Congress and to the
American people demands that we publicly state our goals for the
advancement of diagnosis, treatment, and ultimately cure and even
prevention of mental illnesses.
molecular genetics tools benefit mental illness research
In the foregoing, I have highlighted the enormous public health
need created by the current realities of mental illness, and have
alluded to the way in which NIMH plans to address that need. Of course
the best intentions in research can go nowhere without scientific
opportunities--opportunities based in a well-trained scientific
community, powerful technologies, and good scientific leads.
Fortunately for individuals with mental illness and their families,
there are now unprecedented scientific opportunities to address these
terrible disorders , and it is this conjunction of public health need
with exciting and forward-looking science that truly justifies our
budget request.
At NIMH, a critically important use for new funds is for research
that can capitalize on the fruits of the genome project. As with most
of the serious chronic illnesses that affect humanity, the major mental
disorders have a substantial genetic component. For some of the most
disabling disorders, including autism, schizophrenia, and bipolar
disorder, the genetic aspects of risk are extremely potent, greater
than those observed, for example, for most forms of coronary artery
disease, type II diabetes, or hypertension. Finding the genes
implicated in mental disorders is critical to accurate diagnosis, the
discovery of effective new drugs, and fundamental understanding of the
disease processes. Mental disorders do not result from the
deterministic action of a single gene, but rather result from the
interplay of multiple genes each exerting a small increment of risk,
together with environmental risk factors. Prior to the human genome
project it was hard to see how we would succeed in piecing these
difficult puzzles together. That is all changed now. With the tools of
the genome project in the offing, NIMH-funded investigators are engaged
in large-scale collection of DNA samples from people with
schizophrenia, bipolar disorder, autism, early-onset major depression,
and other disorders. In addition, in the coming year, NIMH plans to
begin to collect DNA samples from the well-characterized participants
in our large-scale clinical trials. In addition to providing
information about the causes of mental illness, genetics can help us to
understand why some individuals respond to one treatment and not
another, helping to usher in an age of individualized treatment. The
result will be appropriate treatment selection for an individual to
maximize efficacy and minimize unwanted side effects.
Modern molecular tools are changing not only genetics, but also
brain biology. The last 3 years have seen steady progress in the
development of technologies in which very dense arrays of DNA or
protein samples are printed on a glass slide or other support. These
functional genomic and proteomic ``microarrays'' permit us to ask, for
example, whether a gene or protein is expressed at a higher or lower
level in diseased tissue versus healthy or in a drug treated sample
versus a control comparison. With a few such slides we can now look for
patterns of change in thousands of genes at once. Promising research
with such microarrays supported by NIMH is underway. In the past year
we saw the first application of these technologies to post-mortem brain
tissue from individuals who had suffered with schizophrenia and other
serious mental disorders. In brains from people with schizophrenia, a
class of genes governing the function of synapses in the brain were
expressed at clearly different levels than those observed in the
comparison brains. This research, published in leading journals, has
opened a new window on the causation of mental illnesses and the
effects of treatment on the brain.
animal models can provide mental disorder phenotypes
It is often not recognized that genetics creates new opportunities,
not only for biologists, but for behavioral scientists. Using the tools
of genetics well demands that we have a greater understanding of the
symptom clusters and course of illness in people who constitute
individual diagnostic groupings. At the same time, we recognize that
the need to understand the precise mechanisms that cause disease
require animal models. The ability to alter the mouse genome, almost at
will, with the resulting production of animals with altered behavior
has revealed a shortage of scientists who can analyze animal behavior
and who can relate it to its neural or genetic substrates. The need for
interdisciplinary scientists, individuals who bridge genetics,
neuroscience, and behavioral science, was highlighted in a report
released in the past year by the Institute of Medicine. Their
thoughtful recommendations on training the next generation of
scientists, scientists who can marshal our new technologies to solve
critical problems related to mental disorders, are currently being
implemented.
In the specific area of animal models aimed at understanding
disease, we have collaborated with other NIH institutes that support
brain research to develop centers around the country that will make
novel mouse mutations and identify neural and behavioral abnormalities.
An important aspect of this program is that all useful models will be
shared throughout the research community. While no one expects to
derive a perfect mouse model of schizophrenia or bipolar disorder,
there is a great likelihood of finding mutations that model significant
aspects of mental illnesses. These will be used to understand what goes
wrong in the brain to produce such disorders, and most important, as
screening tools to develop new treatments. These powerful approaches to
biology--large-scale mouse mutagenesis, and high throughput screening
for behavioral and nervous system phenotypes of interest--span the
interests of multiple neuroscience-based NIH institutes.
clinical trials, including child mental disorder studies
We have also carried out a major expansion of our efforts in
clinical trials. This expansion relates not only to the numbers of
needed trials, but also to their intellectual basis. We have expanded
our trials beyond their usual endpoint-answering the question of
whether a medication or psychotherapy was safe and effective-to
questions of whether our treatments will work for ``real world''
patients in diverse ``real world'' treatment settings such as primary
care clinics and neighborhood health centers.
One important aspect of our clinical trials program is our network
of Research Units in Pediatric Psychopharmacology (RUPPs). In the last
month, these units have produced an important result, published in the
New England Journal of Medicine, showing substantial efficacy and also
safety of a selective serotonin inhibitor (SSRI) drug in the treatment
of children with serious anxiety disorders who had not improved with
behavioral therapy. Given the dire need to establish the safety and
efficacy of treatments for children with depression, bipolar disorder,
anxiety disorders, autism, and many other mental disorders, and given
the initial success of these units, we are delighted that the fiscal
year 2002 budget request should permit an expansion from 7 to 10 units
within the network in the coming year.
The NIH Autism Coordinating Committee (ACC) will work to increase
emphasis in the area of autism research, including more rapid
implementation of the centers program mandated under the Children's
Health Act of 2000.
Later this month, the National Advisory Mental Health Council Child
Workgroup is expected to issue a report recommending that NIMH
strengthen research in this area, including acceleration of
interdisciplinary and multi-site research to develop new
interventions--both psychosocial and pharmacologic--for child and
adolescent disorders and to deploy these treatment strategies to front-
line clinicians. We already are developing fiscal year 2002 initiatives
that will lay the groundwork for a series of child treatment research
networks designed to develop new treatments over the next decade. The
expanded networks will direct resources to research on bipolar
disorder, autism, depression in prepubertal children, and comorbid
conditions that adversely affect child development. A parallel research
network will address the critical question of how we can effectively
disseminate evidence-based care within different provider practices,
communities, and service systems.
john edward porter neuroscience research center
In collaboration with the National Institute of Neurological
Disorders and Stroke and seven other NIH institutes, we are moving
ahead with development of a national Neuroscience Research Center (NRC)
on the NIH campus, a bold initiative that is essentially dictated by
the pace of progress in integrative neuroscience. The new center builds
on the recognition that progress in our science demands that we
overcome any balkanization that has occurred. Specialized investigators
working on discrete facets of brain disease have advanced our field
enormously over the past decade. Now, however, the challenge before us
is to reintegrate the information we have accumulated: to look at
single neurons in the context of larger neuronal ensembles, and those
in the context of brain circuits and systems, all the way up to the
level of the behavior of living organisms. Throughout this testimony I
have described the need to build bridges across disciplines. The
Neuroscience Research Center will serve as a wonderful model for such
collaborations, which can capitalize rapidly on our exciting new ideas
and technologies, and translate as rapidly as possible basic
discoveries into the clinical arena.
Mr. Chairman, 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 second
annual performance report which compares our fiscal year 2000 results
to the goals in our fiscal year 2000 performance plan. As performance
trends on research outcomes emerge, the GPRA data will help NIH to
identify strategies and objectives to continuously improve its
programs. I will be pleased to answer any questions.
______
Prepared Statement of Stephen I. Katz
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Arthritis
and Musculoskeletal and Skin Diseases for fiscal year 2002, a sum of
$443,565,000, which reflects an increase of $46,962,000 over the
comparable fiscal year 2001 appropriation.
It is an honor for me to have this opportunity to share stories of
progress and opportunity in the research within our mission areas.
Improving daily life is the driving force for the research that we
support and conduct at the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS). Virtually every home in
America is touched by diseases affecting bones, joints, muscles, and
skin. We are committed to better understanding, diagnosis, treatment,
and prevention of these diseases and disorders that are often chronic
and disabling, many of which disproportionately affect women and
minority populations.
health disparities
Research has revealed that many of the diseases within our mandate
affect groups such as African Americans, Hispanic Americans, American
Indians, Alaskan Natives, and Asian Americans both in increased numbers
and increased severity. For example, the prevalence of lupus is higher
among African Americans and Hispanic Americans, and these groups also
experience more complications of lupus; African Americans also have
higher rates of hip and knee osteoarthritis; scleroderma occurs with
greater frequency in Choctaw American Indians; and African American
people are also disproportionately affected by overgrowth of scar
tissue (keloids) and by loss of pigmentation (vitiligo), both of which
may be severely disfiguring.
Health Partnership Program. The health of a nation depends on the
health of its communities. Recognizing this, the NIAMS is launching the
first phase of its Health Partnership Program--A NIAMS Diversity
Outreach Initiative, a new program to address the health disparities in
joint, muscle, bone and skin diseases that exist in minority
communities. The initial phase of this Program has begun as a model
community-based program in the African American community in the
metropolitan Washington, D.C., area, with the focus on rheumatic
diseases. As a component of this partnership, plans are also underway
for a new rheumatology clinic to be located in a centrally accessible
area of Washington, D.C.
Recruitment to Research Careers. Specific strategies are underway
and planned to increase the number of underrepresented minority
investigators in the biomedical research fields related to the diseases
within our mandate. The Institute, along with many other NIH
Institutes, has recently issued a Request for Applications for planning
grants for clinical research training in minority institutions as a
first phase of this initiative. The second phase will be a five-year
grant to assist in the actual development of clinical research
curricula. A successful program will produce well-trained clinical
researchers who can lead clinical research projects.
research in children
The NIAMS has undertaken a number of programs and activities
focused on children to enhance our understanding of childhood diseases
and to develop improved treatments for our younger generation. For
example, the NIAMS Intramural Research Program launched an exciting and
promising initiative in the fall of 2000 at the NIH research hospital--
the new NIH Pediatric Rheumatology Clinic. The clinic offers diagnosis,
evaluation, and treatments for children with arthritis and other
rheumatic diseases. The clinic will provide children with a place where
they can be diagnosed and treated in a state-of-the-art facility, and
researchers can learn much more about rheumatic diseases. In addition,
treatment for juvenile rheumatoid arthritis has been significantly
improved with the results of a recent clinical trial that showed
Enbrel (etanercept) is a safe and effective drug in the
treatment of children and teenagers with juvenile rheumatoid arthritis
(JRA). This clinical trial was conducted by researchers at one of the
NIAMS Multipurpose Arthritis and Musculoskeletal Diseases Centers and
investigators in the Pediatric Rheumatology Collaborative Study Group.
The success of this clinical trial is also the culmination of many
years of basic research supported by the NIAMS and other NIH
components. These findings offer hope for children with juvenile
rheumatoid arthritis, hope that they may live their lives as active
children. In other research involving children, we now understand that
osteoporosis may actually start in childhood. Research studies in young
girls revealed that minor variations in a gene for the bone protein
collagen can lead to lower bone density. These minor variations in this
gene, while not causing apparent disease, may define a high
susceptibility group for osteoporosis later in life. Identifying and
understanding genetic susceptibility to osteoporosis early in life may
facilitate the targeting of interventions to those who will most profit
from them.
bone biology and bone diseases
Bone is metabolically a very active tissue, constantly undergoing
build up of new bone and resorption of old bone. Bone remodeling is a
normal, but carefully balanced process. Bone diseases like osteoporosis
can result from an imbalance in this process and osteogenesis
imperfecta can result from the mutation of bone-producing genes, and
both diseases result in low bone density, fragile bones, and increased
susceptibility to fracture. Research has taught us that many factors
affect bone density and strength, including genetic, nutritional,
environmental, and others. Basic research has provided the foundation
for our understanding of bone and has revealed some intriguing and
potentially important scientific opportunities. For example,
researchers found that statins, drugs that lower serum cholesterol,
increase the production of a bone-enhancing molecule. This is leading
to work on the development of similar drugs that can be directly
delivered to the bone for maximum effect. Other studies showed us that
a protein called leptin, which has an established role in controlling
food intake and other aspects of behavior and physiology, seems to
inhibit bone formation in animal models. Researchers will pursue this
finding with the goal of designing drugs to specifically block leptin's
action on bone and restore lost bone.
MUSCLE BIOLOGY AND MUSCLE DISEASES
There are many forms of muscular dystrophy, and the NIAMS has
teamed with our colleagues in other components of the NIH, particularly
the National Institute of Neurological Disorders and Stroke, to bring a
strong focus to basic and clinical studies of muscular dystrophy. Last
year we sponsored major scientific conferences in both Duchenne
Muscular Dystrophy (DMD) and Facioscapulohumeral dystrophy (FSHD),
issued research solicitations signaling our strong interest in the
submission of high quality research applications in understanding and
treating muscular dystrophy, and have funded a research registry for
FSHD and myotonic dystrophy that will facilitate research by serving as
a liaison between families affected by these diseases, and researchers
who want to study these disorders.
SKIN BIOLOGY AND SKIN DISEASES
This has been a particular productive year in research on skin
biology as well as skin diseases. Highlights of progress include: (1)
ground-breaking research on impetigo, a common infection among children
aged 2 to 6. The bacterium Staphylococcus aureus, cause of the common
skin infection bullous impetigo, produces a toxin that attacks a
protein highly specific for cell-to-cell binding in the outermost layer
of the skin. Researchers have reported that breakup of this protein not
only brings about the characteristic blistering, but also gives the
bacterium a specific mechanism to circumvent the skin's protective
barrier and spread further. (2) The gene causing Pseudoxanthoma
Elasticum has been identified. Pseudoxanthoma elasticum is an inherited
disorder characterized by progressive calcification of elastic fibers
in the skin, eye and cardiovascular system. This disease is inherited
and can have severe manifestations in these organ systems. Work is
continuing to determine the function of the gene and how mutations in
the gene result in the clinical disease. This discovery should allow
for the eventual determination of the cause and, ultimately, allow the
design of therapeutic interventions for the treatment of this disease.
(3) Advances in understanding hair development and treating hair
diseases have been reported. A number of skin diseases affect hair
cycle resulting in various abnormal types of hair loss as well as the
hair loss normally associated with aging. An understanding of the
events in hair development, cycling, and the mechanism of hair loss in
various diseases will allow for the development of treatments to
correct these abnormalities. Knowledge of the molecular mechanisms
involved in the continuously repeated cycle of resting, shedding, and
regrowth means that hair biology is useful not only as a way to
understand hair diseases such as alopecia areata, but also for
understanding of other cycling and regenerating tissues. The research
advances that have increased our understanding of the hair follicle
system and the chemicals and signaling molecules involved in its
cycling will allow the development of specific interventions to treat
hair diseases, both naturally occurring, such as alopecia areata, and
those induced by certain cancer chemotherapeutic treatments.
CONCLUSION
The vitality of our bones, joints, muscles, and skin is key to the
length and quality of our lives. Basic research has taught us much
about how these components of our bodies function normally and what
goes awry and causes the enormous number of diseases and disorders
affecting bones, joints, muscles, and skin. Clinical research helps us
to understand the nature of disease, and improves our ability to
diagnose, treat, and prevent disease. Medical research supported by the
NIAMS has made significant strides in improving health and quality of
life, and we are committed to pursuing promising research opportunities
that will continue to improve the health of the American people. We are
investing in the future health of our nation, and American people of
all ages and population groups will benefit from these investments.
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 the NIH's second annual
performance report which compares our fiscal year 2000 results to the
goals in our fiscal year 2000 performance plan. As performance trends
on research outcomes emerge, the GPRA data will help NIH to identify
strategies and objectives to continuously improve its programs.
I will be happy to answer any questions that you may have.
______
Prepared Statement of Gerald T. Keusch, M.D., Director, John E. Fogarty
International Center for Advanced Study in the Health Sciences
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the Fogarty International Center for
fiscal year 2002, a sum of $56,449,000, which reflects an increase of
$5,967,000 over the comparable fiscal year 2001 appropriation.
The Fogarty International Center (FIC) plays a unique role in the
efforts of the United States to improve the health of the American
people and of those who live in developing regions in Africa, Eastern
Europe, Asia, and Latin America. The wealth of nations depends upon the
health of people. A healthy world is a safer world, for our nation and
for those less fortunate with whom we share this amazing and beautiful
planet. Virtually all FIC research and training efforts are aimed at
reducing the disparities in health that exist between the peoples of
the developing world and those who live in countries that enjoy the
vast advantages of prosperity.
FIC was established in 1968 to honor Congressman John E. Fogarty of
Rhode Island. The Center embodies his vision that because ``disease
knows no boundaries, so also the benefits of medical research and
indeed research itself can know no boundaries.'' FIC is carrying this
vision into the 21st Century. Through its leadership role, program
initiatives, and analysis of global science and health policy, FIC
plays a central role in NIH efforts to harness the fruits of science
for global health. Research advances made abroad often contribute to
improvements in health in the United States. For example, research in
Bangladesh establishing the physiological basis and practical use of
oral rehydration therapy for cholera has led to adoption in the United
States of this simple and inexpensive treatment of diarrheal disease,
particularly frequent in infants and children. Research to develop
diagnostic tests, new drugs, and other therapeutic strategies for HIV/
AIDS, tuberculosis, and other diseases present both in the United
States and abroad, is beneficial to all, no matter where it is
undertaken. Adapting biomedical research advances to populations at
home and elsewhere in the world requires a continuing commitment to
basic science as well as rigorous clinical research by both American
and foreign collaborating scientists. Success in these endeavors
requires the creation of a vibrant research infrastructure and trained
research staff in collaborating centers internationally. This is what
FIC does best.
In carrying out its mandate, FIC supports medical investigators in
over one hundred twenty U.S. institutions who collaborate with medical
scientists in more than ninety nations. These efforts are
multidisciplinary, embracing clinical, epidemiological, basic
biomedical, and behavioral research. Although FIC acts to foster
collaborative efforts in all parts of the world, it has placed special
emphasis on training medical research personnel in those nations with
the least resources. Such countries bear a disproportionate burden of
illness and premature death, not only from communicable diseases but
from non-communicable chronic diseases as well.
CHALLENGES IN GLOBAL HEALTH
FIC efforts to address the challenges in global health research are
carried out through 20 research and research capacity building
programs, as well as through policy and coordination efforts. With more
than 35 million persons worldwide infected with HIV, AIDS is a global
emergency and has been identified as a threat to our national security.
In addition to individual tragedy, one person at a time, there are
profound societal consequences including economic loss, social
disintegration, and political instability. ``Each man's death
diminishes me,'' wrote John Donne centuries ago, ``because I am
involved with mankind.'' AIDS prevention, treatment, care, and
ultimately cure are universal concerns because the people of the world
are increasingly connected by trade, travel, and, unfortunately,
threats to health.
To address the burgeoning pandemic, FIC launched the AIDS
International Training and Research Program (AITRP), now in its 13th
year. AITRP has provided research training for more scientists and
health professionals from developing countries than any other program,
fostering collaborative links between research institutions in the most
affected areas in Africa, Asia, and South America and leaders of
American medicine. AITRP trainees have been in the vanguard of the most
successful efforts to reduce new infection and to keep infection rates
low. Their efforts have contributed to numerous scientific discoveries
and implementation of programs to reduce HIV transmission. Now that
antiretroviral therapy may be within the reach of the highly stricken
poor nations, a massive effort to build organizational infrastructure
and train the large number of professionals required to assure the safe
and appropriate use of these complex drugs is the critical bottleneck
to success. Having developed extensive HIV research and training
networks among U.S. Schools of Medicine and Public Health and
counterparts in developing nations, FIC is in a unique position to
enlarge the pool of professionals necessary to support such an effort.
We cannot afford not to succeed.
Malaria, once rampant in the United States, including this capital
city, has resurged and spread in endemic regions in Latin America,
Africa and Asia. An added complication is that the malaria parasite has
developed drug resistance. For these reasons, Americans remain at risk
when they travel to endemic regions of the world, each year in
increasing numbers. New strategies are needed to meet this global
challenge that claims approximately 2.7 million lives annually, largely
in tropical countries. FIC has implemented a new malaria research and
training program to link research to control. In addition, FIC efforts
to create a global coalition to address malaria have resulted in the
Multilateral Initiative on Malaria (MIM), a new type of international
collaboration designed to create research capacity among African
scientists and to generate information in the field. As the current MIM
Secretariat, FIC has overseen the enlargement of the MIM research
portfolio, expanded its training activities, and increased the number
of sponsoring partners. Today, MIM is the essential research
counterpart for Roll Back Malaria at WHO and together these two
initiatives represent the major global collaborations to combat
malaria.
Well over ten million people in the United States and 2.1 billion
people worldwide are infected with the tubercle bacillus. This ancient
infection still results in more than 2 million deaths annually. One
third of tuberculosis in the United States is attributed to infection
contracted elsewhere and effective treatment is thwarted by the global
emergence of TB strains with multiple drug resistance. To meet this
threat, FIC started the Tuberculosis International Training and
Research Program that focuses on improving clinical and laboratory
practices and the training of medical research scientists. Now in its
5th year, it is an essential component of the global strategy to
contain the tuberculosis epidemic and has led to important new control
measures. One product of this research is a rapid, reliable, simple and
inexpensive diagnostic test, which can be adapted to determine drug
susceptibility.
Loss of plant and animal biodiversity is a worldwide phenomenon.
The medical consequences, though less obvious, are just as serious as
the effects on ecology. With the loss of plant biodiversity there is an
irrevocable loss of natural products that have traditionally been the
source of front line drugs such as quinine for malaria and digitalis
for heart disease. The FIC-led International Cooperative Biodiversity
Groups Program is a model for ethical bioprospecting in the search for
new drugs while it promotes high quality science through multi-purpose
partnerships between U.S. and developing country universities, major
pharmaceutical companies, and non-governmental organizations. More than
6,000 species have been examined for biological activity in 13
therapeutic areas. Fifty substances of interest have been found and 15
have been selected for further research because initial studies
indicate they may prove useful to treat malaria, leishmaniasis, and
tuberculosis.
In response to the increasingly complex questions concerning the
social and ethical dimensions of international research, FIC initiated
and organized the Global Forum on Bioethics in Research, the first
international effort to address critical issues related to the
bioethics of conducting research in developing countries. FIC also
established the first international bioethics training and research
program to develop a cadre of qualified ethicists and health
professionals from the developing world who can work in partnership
with clinical investigators. They will shape and implement research
programs and ethical research policies in their home countries to
insure that human subjects receive equal protection from research
risks, as do participants in research in the United States.
In collaboration with the National Science Foundation, FIC
initiated a research program to study the role of ecological factors
that influence the emergence of infectious diseases. This program
addresses a critical need, to predict and prevent an infection from
emerging rather than confront it after the problem appears. It brings
together unique research teams composed of climatologists,
epidemiologists, ecologists, vector biologists, entomologists, and
microbiologists to develop predictive models of emerging infections.
For example, the last El Nino preceded an upsurge in diarrheal disease
in Latin America and malaria in Africa. To be forewarned is to be
forearmed.
Under FIC leadership, innovative research is being initiated to
investigate linkages between investments to improve health and economic
performance in developing countries. Healthier people living better
lives remains an elusive dream and the Alma Ata declaration has fallen
far short of its lofty goal of ``Health for All by 2000.'' Research
results from FIC's International Studies in Health and Economic
Development Program will help the U.S. and other nations working to
enhance economic development in the poor countries of the world
understand how best to achieve, at lowest cost, the goals of healthier,
better educated people living better in politically stable nations
around the world.
As we look to the future, FIC will both strengthen existing
programs and respond to needs and opportunities with innovative new
initiatives.
FISCAL YEAR 2002 INITIATIVES
To address the growing pandemic of tobacco-related illness and
death, now shifting from the developed to the developing nations, FIC
will explore how to diminish the initiation of smoking by youth and
adolescents. The objective of the International Tobacco and Health
Research and Capacity Building Program is to generate scientific
information on biological, behavioral, and policy factors that will
lead to effective control measures to reduce smoking initiation and
enhance cessation. The results of these efforts will be applicable in
the U.S.
New advances in clinical research are needed to translate basic
research into clinical practice and to develop effective public health
policy and programs. There are too few well-trained clinical
researchers in low- and middle-income countries. Even fewer have policy
experience to deal with research and health care. Clinical researchers
are needed to address multi-dimensional medical care needs for AIDS
patients, and the prudent use of antibiotics to deter the further
emergence of antibiotic resistance. Travelers, refugees, and pilgrims
spread resistant microbes worldwide with shocking speed. The
International Clinical, Operational, and Health Services Research and
Training in Communicable Diseases program will train new clinical
researchers in developing countries who understand how to translate
their research into practice.
Since Biblical times, those afflicted with disfiguring illnesses of
body and distortions of mind have been shunned and cast aside. Such
stigma is a burden both to the afflicted and the social compact.
Stigma, acting through prejudice, diminishes patients' access to care
and even their participation in research designed to alleviate
suffering. The Stigma Research Initiative will examine the causes of
and response to stigmatization of patients with such diseases as HIV,
mental illness, epilepsy, drug or alcohol addiction, and physical
disabilities, in the U.S. and abroad. Through epidemiological and
social science studies on the roots of stigma, its expression and
outcomes, new strategies can be identified and tested to relieve its
effects and to enhance the well being of patients, communities, and
nations.
Publication of the human genome is an extraordinary achievement
that creates a wealth of opportunities to identify genetic determinants
of susceptibility and resistance to disease. New discoveries to prevent
and treat infectious diseases will stem from this knowledge, aided
especially by new information on the genomes of microbial pathogens
(most recently Strep pyogenes, the cause of ``strep throat'', rheumatic
fever, ``flesh eating'' necrotizing fasciitis, and toxic shock) and
insect vectors. Now for the first time, scientists can target with
precision the development of a drug or a vaccine for a specific
microbe. For example, over a dozen genes have been identified that
relate to the susceptibility to malaria. Efforts in malaria vaccine and
drug development are now utilizing this new information.
From the very beginning of research on the human genome there has
been concern about ethical issues that relate to medical applications
and the protection of the individual. To permit the expansion of
genetics research in developing countries, a new program, Incorporating
New Genetic Tools into Global Health Strategies, will foster the
development of ethically responsible international research and
training in the use of modern genetic technologies. U.S. and foreign
scientists will forge collaborations to define the genetic influences
on conditions that affect both populations, and to discover the ways
and means to improve health and reduce disparities at home and abroad.
CONCLUSION
The pursuit of health through international scientific cooperation
is an inherently global enterprise and one that ultimately improves the
public health of our nation. Just as trade and communications have tied
the world together, advances in biology have demonstrated our social
and global interdependence. ``Science knows no country'', said Louis
Pasteur ``because it is the light that illuminates the world.'' The
genome project, the recognition that improved health is a determinant
of economic development, and the impact of ecological changes on the
emergence of infectious diseases all contribute to a deepening
consensus that individuals and nations share common interests and
responsibilities. The programs of the FIC advance this vision though
their support of research and training focused on global health
disparities and enabling effective collaborations between American and
foreign scientists. FIC leadership and accomplishments enhance our
national efforts to achieve better health for Americans and for those
less fortunate in the developing world.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
Thank you Mr. Chairman. I will be pleased to answer any questions.
______
Prepared Statement of Richard D. Klausner
Mr. Chairman and Members of the Subcommittee: I am Richard
Klausner, the Director of the National Cancer Institute (NCI). I am
pleased to appear before you to present a brief review of some of the
activities supported by the NCI and to present the President's budget
proposal for fiscal year 2002. The significant budget increases over
the past several years have allowed the NCI to aggressively implement
its strategic plans to:
--Support a broad-based portfolio of superb research to increase our
knowledge about all aspects of cancer.
--Translate basic science to transform all aspects of cancer
prevention and care
--Train the next generation of cancer researchers
--Address both the quality of cancer care and the disparate burden of
cancer experienced in America across the cancer continuum.
CANCER TRENDS
Four years ago, the NCI initiated an annual report to the Nation on
the burden of cancer. This report is developed in collaboration with
the American Cancer Society, the Centers for Disease Control and
Prevention and its National Center for Health Statistics. This spring,
we will report the latest cancer statistics for the country through
1998. Total cancer death rates are falling now by 1.1 percent per year
with black males showing the largest drop of 2 percent per year. For
breast and prostate cancer, death rates are now falling by 3.5 percent
per year. Despite overall progress, incidence and/or death rates for
some cancers are rising. These cancers, which include esophageal
cancer, liver cancer, non-Hodgkin's lymphoma, acute myelogenous
leukemia and melanoma, account for about 13 percent of the total cancer
burden in the U.S. The NCI has convened task forces and directed new
research to understand these trends.
The full and accurate assessment of the U.S. cancer rates is at the
foundation of our ability to define the cancer burden, detect trends
and pinpoint geographic and demographic variables and disparities. For
30 years, the NCI's Surveillance, Epidemiology and End Results (SEER)
Program has been the gold standard for cancer registration worldwide.
This year, we announced a major expansion including California,
Louisiana, Kentucky and New Jersey, and SEER now covers 26 percent of
the U.S. population. We will increase the coverage of the rural
population by 150 percent, of the population below the poverty line by
200 percent, of Asian Americans by 200 percent, of non-Mexican
Hispanics by 70 percent and of Native Americans by 36 percent.
We have expanded and will continue to expand what we call Rapid
Response Studies which allow researchers and NCI staff to rapidly
respond to urgent issues that are revealed by cancer surveillance. We
have greatly expanded our capacity to monitor, report and evaluate
geographic differences in cancer burden. This involves a three-pronged
approach. First, we are continually improving our analyses and
dissemination of cancer mortality maps so that they are useful to
researchers, local officials and policy makers. Second, we have
provided a fund to encourage researchers to propose hypothesis-testing
studies associated with geographic variations in cancer. Third, we are
greatly expanding the funding for and management of Geographic
Information Systems (GISs) to create computer systems that allow
examination and tracking over time and space of cancer rates with any
geographically defined factor that might contribute to the cancer
burden. About 30 applications have been received in response to this
new initiative.
EARLY DETECTION RESEARCH
New approaches, based on genomics, proteomics and other emerging
technologies, are being systematically pursued to reach the goal of
developing effective and reliable tests for the earliest possible
detection of all cancers and even of pre-cancers. The Early Detection
Research Network (EDRN) is a major new initiative of the NCI to create,
for the first time, a national R&D enterprise to discover biomarkers of
cancer, develop reliable tests and validate them with clinical studies.
The EDRN is a partnership between NCI, other government agencies,
industry and academics; in its first year, dozens of potential markers
are being studied and three are moving towards validation studies. The
need to develop effective early detection for lung cancer aimed at
current and former smokers at risk for this deadly disease is clear. We
are actively pursuing the possibility that low dose, helical Computed
Tomography might provide a new method to detect early and potentially
curable lung cancers. A randomized trial to compare standard screening
mammography with digital mammography for the detection of breast cancer
is being initiated and we continue to closely monitor the results of
NCI's large randomized trial to finally determine the clinical value of
PSA in prostate cancer screening. Even our most successful cancer
detection tool, the Pap smear, can use improvement. A recent NCI study
has addressed ways to make the test more predictive of serious findings
for the large number of Pap smears that are currently read as being of
uncertain significance and whose evaluation is estimated to cost as
much as $1 billion per year. A DNA test looking for the virus that
causes cervical cancer can successfully predict which of these Pap
smears can be safely ignored and which require follow-up.
DIAGNOSIS
Two years ago, the NCI announced a major new program aimed at
utilizing the emerging knowledge of the genome to create new approaches
to the diagnosis of cancer, indeed to potentially change the very names
and classifications being applied to human cancer. This program, called
the Director's Challenge, has been responded to by a consortium of
researchers from around the country who will attempt to redefine the
classification of leukemia, lymphoma, lung, prostate, breast,
colorectal, brain, ovarian, childhood and other cancers. Results have
begun to emerge demonstrating that cancers currently lumped under one
diagnosis are actually multiple molecularly distinct diseases. For at
least one group of cancers called diffuse large cell lymphoma, this
previously hidden heterogeneity may explain why only 50 percent of
patients can be cured with current therapy. Rather, it now appears that
this cancer is actually at least two different diseases, one of which
is almost always cured by current therapy and the other of which is
almost never cured. This program will accelerate progress towards
achieving a long-held dream of being able to correctly classify human
cancer.
MOLECULAR TARGETS: A NEW ERA IN THE DISCOVERY AND DEVELOPMENT OF
PREVENTIVE AND THERAPEUTIC AGENTS FOR CANCER
Revealing the actual molecular machinery of cancer has long
promised to bring a new, highly selective approach to both prevention
and treatment. Examples of molecularly targeted therapy for cancer are
beginning to emerge. For example, chronic myelogenous leukemia (CML) is
known to be the result of the breaking and recombination of two
chromosomes. The fused chromosomes produce a new gene which tells the
cell to produce a protein called bcr-abl whose uncontrolled activity is
responsible for the growth of the leukemia cell. A new drug, called
STI571, developed as a collaboration between Novartis Pharmaceuticals
and NCI-funded investigators, is highly effective at turning off the
activity of bcr-abl. In recently published studies, virtually every
patient with the chronic phase of CML, the disease expressing the
molecular target, has shown a complete correction of their blood
abnormalities. This is an oral drug with apparently few and mild side
effects. We now know that this same drug has activity against two other
distinct molecular machines present in a variety of cancers. As a
result, the NCI in collaboration with Novartis is rapidly developing
numerous clinical trials to test STI571, alone or in combination with
other drugs, in leukemia, gastrointestinal sarcomas (in which dramatic
responses have already been seen), brain tumors, lung, prostate,
breast, ovary and pediatric cancers.
To expand the discovery, validation and development of more
molecular targets in cancer, the NCI has initiated a series of funding
programs including:
1. Molecular Targets Drug Discovery (MTDD) grants--four new grant
programs to discover and validate molecular targets for cancer for
which we have received over 170 applications.
2. Interdisciplinary Research Teams for Molecular Target Assessment
(IRT/MTA)--a new approach to the development of clinically useful
assays to measure and monitor cancer in patients according to the
actual molecular targets where treatment is directed.
3. Chemistry/Biology Centers--we have funded six centers of
excellence to bring chemists and biologists together to discover
chemicals that report on and can perturb the molecular machinery of
cancer.
This year we hope to establish one to three large contract efforts
called National Molecular Target Laboratories (MTLs). These are
envisioned as genomic-scale efforts to discover molecular probes for
all potential cancer relevant molecular targets.
We hope to expand the Rapid Access to Interventional Development
(RAID) program, which was established two years ago to take potential
therapeutics from academic or small business laboratories and turn them
into drugs ready to be tested in phase I clinical trials. In its first
two years, RAID is supporting 51 novel agents and we hope that 11 will
reach the clinic by the end of this year.
The way scientific discovery eventually leads to advances in
medical practice is through the clinical trial. Currently, the NCI is
actively accruing patients (about 25,000 a year) to over 840 clinical
trials including about 700 early phase trials where we can test the
safety and possible effectiveness of new agents. In fiscal year 2000,
261 new trials were opened compared to 177 in fiscal year 1999. Our
goal is to double the number of new agents entering such clinical
testing over the next two years. Over the past year, completed clinical
trials have demonstrated new treatment regimens that show a 50 percent
increase in survival for resectable gastric cancer and a 40 percent
increase in survival rates for metastatic renal cancer, to cite just
two examples.
Over the past year, we have been implementing our strategic plan to
address the pressing question of cancer disparities through our Quality
of Cancer Care initiatives, our newly formed Center to Reduce Cancer
Health Disparities and our Comprehensive Minority Biomedical Programs.
Eighteen Special Population Networks for Cancer Awareness, Research and
Training have been launched as have 12 new partnership programs between
NCI-funded Cancer Centers and Minority Serving Institutions. These and
other activities are aimed at increasing our understanding of cancer
disparities, increasing the participation of minority and underserved
communities in the cancer research enterprise and finding ways to
address the disparities in cancer burden.
I am pleased to present the President's budget request for the
National Cancer Institute for fiscal year 2002, a sum of
$4,177,203,000, which reflects an increase of $439,275,000 over the
comparable fiscal year 2001 appropriation.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
______
Prepared Statement of Claude Lenfant
Mr. Chairman and Members of the Committee: I am delighted to
address this Committee once again on behalf of the National Heart,
Lung, and Blood Institute (NHLBI). Let me begin by thanking you for
your longstanding and generous support of our research programs and
activities, and highlighting two examples of the benefits that have
accrued to the American public.
SICKLE CELL DISEASE
As the following illustration indicates, we have made tremendous
progress in our battle against sickle cell disease since our programs
began about 30 years ago.
Patients with sickle cell anemia now live, on average, into their
mid-forties, and average life expectancy for patients with a related
condition, SC-hemoglobin disease, has climbed to the mid-sixties. These
dramatic increases are highly correlated with the development and
fruition of key NHLBI research programs that have provided an array of
treatments and preventive regimens for the patients. Care that was once
fragmented and often administered in an emergency setting is now
coordinated, beginning with screening of newborns, provision of
appropriate control of infections, and prevention of stroke in high-
risk children through transfusion therapy.
Continued progress can be expected as we capitalize on new
opportunities made feasible by recent increases in the NHLBI budget.
For instance, we have funded studies of bone marrow transplantation in
children with sickle cell disease. At least 50 children have undergone
successful transplants, leading the way for further studies of this
curative process. We have expanded our studies on the drug hydroxyurea,
which has been shown to decrease painful crises in adult patients by 50
percent, to determine whether this may prove safe and effective in
children, as well. Additional trials are also being initiated to
determine how best to manage the long-term care of children with sickle
cell disease who are receiving chronic transfusions.
CONGENITAL CARDIOVASCULAR MALFORMATIONS
Congenital cardiovascular malformations are the most common birth
defect in the United States, affecting nearly one of 100 newborns, or
about 40,000 infants each year. While these malformations remain
leading contributors to infant mortality, the chances that an affected
baby will live to celebrate a first birthday are far better today than
they were several decades ago. This progress, illustrated in the
following chart, is testimony to the success of research that has
greatly improved our ability to diagnose and treat congenital heart
disease. Whereas a half-century ago, an accurate diagnosis could be
made only at autopsy, nowadays many heart defects can be diagnosed in
utero. Doctors no longer sit by helplessly as babies weaken and die,
because they now have an armamentarium of surgical and medical
approaches, as well as reliable and effective methods for monitoring
and supporting these infants.
Nonetheless, many challenges remain, and we have expanded our
research programs to meet them. Although we have enjoyed much success
in treating congenital cardiovascular malformations, their incidence
has remained quite high and their appearance is often unexpected and
unpredictable. Effective preventive strategies await a better
understanding of the genetic and environmental factors that influence
heart development. In that regard, we are very pleased to have been
able to increase our program of Specialized Centers of Research (SCORs)
in Pediatric Cardiovascular Diseases, which provides opportunities for
basic and clinical scientists to collaborate in unraveling complex
problems such as this. During fiscal year 1999-the initial year of the
major expansion in our appropriations-we added two centers, bringing us
to a total of five.
During the current fiscal year, we are establishing a Pediatric
Heart Disease Clinical Research Network to facilitate development and
refinement of new treatment protocols. This program will allow for
rigorous evaluation of therapeutic regimens for a wide variety of
cardiovascular malformations, and promote rapid dissemination of the
findings to the medical community.
UNDERSTANDING HEALTH AND DISEASE
Over the years, I have emphasized the importance of a comprehensive
approach that looks at health and disease from a variety of
perspectives. Good (or ill) health rests on a tripod of genes,
environment, and behavior. Let me provide some examples of NHLBI
activities that address each of these issues.
GENETICS AND GENOMICS
The much-publicized sequencing of the human genome has brought with
it tremendous excitement and opportunity. Coordinated efforts are
already under way to extend the range of fully sequenced animal models
so that comparative genomics can be used to identify human genes and to
determine their functions. In this regard, the NHLBI has made a major
investment in sequencing the genome of the rat, which has great
applicability to many of the diseases under our mandate. In addition,
intensive efforts are already under way to begin translating our
knowledge of the structure of the genome into a working knowledge of
its functions. The new NHLBI Programs of Genomic Application, the
largest Institute initiative in our history, are pursuing this goal
with vigor and creativity.
The notion of using gene therapy to cure inherited diseases has
long been a dream of scientists, and in some areas such as hemophilia,
we have every reason to believe that it may soon become a reality. Our
research in this area is gaining additional momentum with funding of
new Centers of Excellence in Gene Therapy, which are designed to move
these studies rapidly into the clinical arena within the context of
careful and appropriate safeguards for patient safety and welfare.
Although gene therapy is certain to continue to attract considerable
interest, it is our belief that the biggest public health payoff of our
emerging genomic knowledge may lie in the ability to understand
individual differences in disease prognosis and treatment. We are
already seeing exciting reports of genetic variations that account for
differences in the manifestations and course of heart failure and
differences in the effectiveness of asthma medications. The ability to
predict, for a given patient, whether disease will be benign or severe
and whether a drug will have beneficial or adverse consequences would
truly revolutionize the practice of medicine.
EXTERNAL INFLUENCES
It has been said that one's genes load the gun, but the environment
pulls the trigger; that is certainly true in the case of many chronic
diseases. Consider, for example, chronic obstructive pulmonary disease
(COPD). Some smokers develop COPD but many others do not, which
suggests that genes influence individual susceptibility. However, the
observation that very few nonsmokers ever develop COPD suggests that
whether or not the genetic gun is loaded is irrelevant in the absence
of the environmental trigger-cigarette smoke.
In the area of asthma we are looking to environmental factors as a
possible explanation for the startling increases in asthma prevalence,
which have occurred over too short a period of time for genetic factors
to be the culprits. Research has produced some evidence that a more
Westernized lifestyle that includes increased household furnishings,
humidity, and temperatures; decreased ventilation; and increased time
spent indoors may result in greater allergic sensitization. A number of
studies have linked obesity with asthma in both adults and children,
and burgeoning levels of overweight in the U.S. population are thought
to be due, in part, to decreased physical activity. Still other work
has advanced the somewhat counterintuitive hypothesis that modern lack
of exposure to infections-because of immunization, antibiotic use, or
generally improved hygiene-may adversely affect immune system
development and lead to heightened susceptibility to asthma. We are
avidly pursuing these and other leads in the hope of uncovering some
MEANS OF STEMMING THIS RISING PUBLIC HEALTH PROBLEM.
BEHAVIOR
Understanding and changing health-related behaviors is critical if
we are to make the most of the new discoveries of the research
enterprise. Behavior is, of course, intimately connected with
environmental exposure; inhaling smoke, consuming food, and taking
prescription drugs are all behaviors.
Our national education programs have been quite successful in
increasing public awareness and control of hypertension and high blood
cholesterol, for example, but there is still considerable room for
improvement, especially in certain vulnerable subsets of the
population. To address this issue, the NHLBI recently established
Enhanced Dissemination and Utilization Centers (EDUCs) as a means of
extending the health benefits associated with current clinical
guidelines and medical information. A total of 13 EDUCs have been
established in communities at high risk for asthma or cardiovascular
disease. They are using information generated by the Institute's
education programs to inform their communities of the public health
burdens of asthma and cardiovascular disease and to develop, implement,
and evaluate educational strategies to reduce the burden. We believe
this new approach will provide a solid foundation for our efforts to
address Healthy People 2010 performance objectives of eliminating
racial/ethnic and geographic disparities in underserved high-risk
populations.
Our interest in this area encompasses not only the behavior of
patients and the general public, but also the behavior of health care
providers who dispense advice and prescribe medications. We are placing
enormous emphasis on translation of new research results into clinical
practice. It is of great concern that the results of definitive
clinical trials indicating, for instance, the proven benefits of lipid-
lowering therapy in patients with high cholesterol or beta-blocker
therapy for heart attack survivors have not been widely applied to
patients. We are committed to using every avenue at our disposal to
close this gap between bench and bedside and reap the greatest public
health return on our research.
AMOUNT OF PRESIDENT'S REQUEST
I am pleased to present the President's budget request for the
NHLBI for fiscal year 2002, a sum of $2,567,429,000, which reflects an
increase of $268,329,000 over the comparable fiscal year 2001
appropriation.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
I would be pleased to respond to any questions that the Committee
may have.
______
Prepared Statement of Dr. Donald A. B. Lindberg, Director, National
Library of Medicine
I am pleased to present the President's budget request for the
National Library of Medicine (NLM) for fiscal year 2002, a sum of
$275,725,000, which reflects an increase of $29,374,000 over the
comparable fiscal year 2001 appropriation.
The Library is a key element in the foundation of the biomedical
research enterprise. It is said that scientific research begins and
ends in the library: from learning about the latest that has been
published before embarking on an experiment, to publishing the results
of that experiment in a journal that finds its way into an online
database and onto the library shelf. In the health sciences, the
institution that plays the role of information collector, organizer,
and disseminator is the National Library of Medicine. The NLM not only
maintains two buildings in Bethesda to house this unparalleled resource
(with treasures dating to the 11th century), but the Library is the
creator of immense electronic data resources that may be used, free, by
anyone in the world.
There is a second aspect of the NLM's infrastructure role as
creator, nurturer, and backup for national and international medical
information networks. The U.S. National Network of Libraries of
Medicine, created by NLM in the sixties, is an organization of 4,500
member institutions that provide vital information services to American
health professionals and, increasingly, to the public. NLM is
encouraging medical libraries to work closely with public libraries and
other community organizations to provide the public with access to high
quality health information. The NLM sponsors special programs within
the network to support improving information services in areas that
disproportionately affect minority groups, such as HIV/AIDS and
toxicology and environmental health. There are also special outreach
programs within the network for Native Americans and Spanish-speaking
minorities. The Library supports an international medical information-
sharing network so that it can both receive scientific information from
foreign institutions and also provide their researchers and health
professionals with access to NLM's electronic information resources.
Primary among these electronic resources is MEDLINE, the Library's
immense database of references and abstracts to journal articles. With
current usage of more than 250 million searches a year, it is the
world's most-used medical literature resource. An easy-to-use Web-based
program, known as PubMed, is the popular route of access. It takes only
a few seconds to search through an ever-expanding collection of 11
million references and abstracts culled from more than 4,000 journals,
covering the world-wide literature from 1966 to the present. The PubMed
system also has links to 1800 participating publishers Web sites so
that users can retrieve full text versions of articles identified in a
MEDLINE search. A new feature, introduced in 2001 by the NLM and the
National Center for Complementary and Alternative Medicine because of
widespread public interest in the subject, is the ability to search a
database limited to the literature of alternative medicine ( CAM on
PubMed ). One unforeseen outcome of making MEDLINE available free on
the Web was that the database was discovered by the general public and
quickly became a favorite source of medical information. Today, the
Library estimates that one third of MEDLINE searching is done by
consumers.
BROADENING THE MANDATE
The enthusiasm with which the public embraced MEDLINE on the Web
has altered the traditional role of the NLM, which was to serve the
nation's health by providing information services through health
professionals, scientists, educators, and practitioners. The Library
maintains those time-honored services, but now also serves the public
directly with information products created specifically for consumers.
MEDLINEplus and ClinicalTrials.gov are examples of Web-based services
that the public can access directly. The most broad-based of these is
MEDLINEplus.
With help from members of the National Network of Libraries of
Medicine across the country, the information specialists who maintain
MEDLINEplus select and organize a variety of consumer health
information issued by the National Institutes of Health, professional
medical societies, and voluntary health agencies. MEDLINEplus not only
has extensive information on more than 425 diseases and health
conditions, but an extensive medical encyclopedia, detailed information
about prescription drugs, directories of health professionals and
hospitals, health-related articles from the daily news media, patient
education modules, and links to a variety of organizations that
disseminate information on various health problems. MEDLINEplus also
makes it easy for the consumer to search MEDLINE for up-to-date
information from the scientific literature. The Library is working with
the National Institute on Aging to introduce more information related
to the health of seniors, such as Alzheimer's disease, and to put the
information into a format that is easily accessible by that segment of
our population.
MEDLINEplus has become tremendously popular and now logs about 5
million page hits per month. The NLM has also learned that health
professionals of all kinds are finding it to be an excellent source of
information. Many physicians use it to keep up-to-date on medical
subjects outside of their specialty. Others are referring their
patients to MEDLINEplus for up-to-date and authoritative information
about their health conditions.
One of the most useful features of MEDLINEplus is the ability to
learn about clinical trials. The Web site ClinicalTrials.gov, developed
by NLM, became publicly available in February 2000 and has already
proved to be of great help to physicians, patients, and their families.
ClinicalTrials.gov is a registry of more than 5,000 federally and
privately funded trials of experimental treatments for serious or life-
threatening diseases or conditions. It is being expanded to include
more clinical trials sponsored by private companies and some performed
in other countries. The database includes 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 contact information. ClinicalTrials.gov is linked closely
with MEDLINEplus, so that anyone looking for information about a
particular disease or condition can easily tell it is the subject of
any clinical trials. There is no registration for either MEDLINEplus or
ClinicalTrials.gov, and complete privacy is assured to all users.
SCIENCE ADVANCES
The National Library of Medicine's involvement with the
infrastructure of medicine extends far beyond its collection and the
services built upon it. NLM is also a leader in providing crucial
components of medical infrastructure for the 21st century. One aspect
of this is ensuring that the nation's biomedical research enterprise
has the trained professionals it needs in computational biology,
including mathematical modeling in the life sciences, advanced imaging,
and molecular biology. This role was brought into focus in the NIH
report, The Biomedical Information Science and Technology Initiative
(BISTI), which recommends that the NIH invest heavily in computer and
information technology. As a result of BISTI, the NLM is expanding the
12 medical informatics training programs it supports at major
universities to carry out research in general informatics and in
Medical Genomics.
The Library also has internationally recognized program in medical
genomics, organized within the National Center for Biotechnology
Information (NCBI). The NCBI plays a pivotal role in coordinating,
integrating, and disseminating the growing body of data currently being
generated by the sequencing and mapping initiatives of the Human Genome
Project. These efforts are complemented by the inclusion of individual
genomic sequences, from over 75,000 organisms, submitted to NCBI from
scientists worldwide, as well as the data generated through the
collaborative projects aimed at sequencing the genomes of other model
organisms. NCBI has also designed a novel system for linking its
genomic resources to the biomedical literature, a necessary step for
providing quality assurance, as well as for providing a framework for
associating the most current and comprehensive biological information
about a genomic sequence. Hence, NCBI's readily accessible genomic and
literature databases, as well as their publicly available data analysis
tools, represent a true international information infrastructure
designed to facilitate and propel the biomedical research advances that
will ultimately lead to better health for the American public.
Because the NLM depends to a great extent on the Internet for
disseminating its many health information services, it is a supporter
of the infrastructure initiative known as the Next Generation Internet.
This is a cooperative effort among industry, academia, and government
agencies that seeks to provide affordable, secure information delivery
at rates thousands of times faster than today. Some NLM health
applications, for example those involving the Visible Humans and
telemedicine, require more bandwidth and more reliable service than are
currently available. The Visible Human male and female data sets,
consisting of MRI, CT, and photographic cryosection images, are huge,
totaling some 50 gigabytes. They are being used by scientists around
the world in a wide range of educational, diagnostic, treatment
planning, virtual reality, artistic, mathematical, and industrial uses.
Projects run the gamut from teaching anatomy to practicing endoscopic
procedures to rehearsing surgery. One new project, being carried out by
NLM scientists, is AnatLine, a web-based image delivery system that
provides retrieval access to large anatomical image files of the
Visible Human male thoracic region, including 3D images. Another is the
collaborative project with other NIH Institutes to develop a super-
detailed atlas of the head and neck. The Visible Human Project is an
example of a program that requires both advanced computing techniques
and the capability of the Next Generation Internet if it is to be
maximally useful.
The Library also funds innovative medical projects that demonstrate
the application and use of the capabilities of the Next Generation
Internet. These projects span the spectrum of medical disciplines,
geographic areas, and target audiences. One example is to evaluate the
potential of telemedicine applications on the health care system in
rural Alaska as a way of improving the quality of health care while at
the same time containing costs. Another project, in rural Iowa, is
measuring the effectiveness of video consultations for patients with
special needs, including children with disabilities and persons with
mental illness. In addition to supporting such advanced applications,
the NLM continues its research on evaluating the performance of today's
Internet pathways between and among health institutions and users. This
research gives us a glimpse into what the future holds.
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 second annual performance
report which compares our fiscal year 2000 results to our goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
______
Prepared Statement of Alan I. Leshner, Ph.D., Director, National
Institute on Drug Abuse
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute on Drug
Abuse, a sum of $907,369,000, which reflects an increase of
$126,394,000 over the comparable fiscal year 2001 appropriation.
nida's comprehensive portfolio
New scientific discoveries are fundamentally changing how this
Nation approaches drug abuse and addiction. As we speak, more and more
diverse patient populations are receiving the best treatments that
science has to offer as a result of the work of our National Drug Abuse
Treatment Clinical Trials Network. Promising new medications for
treating addiction to nicotine, methamphetamine, cocaine, heroin, and
other drugs are being tested and developed further. And, our increasing
knowledge about the health and developmental consequences of drugs of
abuse, particularly emerging drugs like Ecstasy (MDMA), is allowing us
to rapidly provide communities with the science-based tools to prevent
and treat drug problems at the local level. It is the tremendous
advances from science, fueled in part by the very generous increases in
the past several budget cycles, that have allowed the National
Institute on Drug Abuse (NIDA) to accomplish these momentous
achievements and are providing us with renewed hope for a safe and
healthy drug-free citizenry.
NIDA supports more than 85 percent of the world's research on the
health aspects of drug abuse and addiction, including the impact that
drugs have on other diseases such as AIDS, hepatitis C, and
tuberculosis. Because NIDA is so central to the entire research
enterprise, the Institute maintains a very comprehensive research
portfolio. We focus on all drugs abuse, both legal and illegal,
including nicotine, with the exception of a primary focus on alcohol.
NIDA also rapidly translates all of its new findings into formats that
will be useful and used by a variety of audiences. I will highlight
some recent accomplishments and mention a few promising directions.
national drug abuse treatment clinical trials network
One of the best examples of the impact that science can have on
local communities is in the treatment arena. Thanks to recent treatment
advances, NIDA was able in fiscal year 1999 to jump-start and then in
fiscal year 2000 to greatly expand what has quickly become a national
clinical research infrastructure for testing science-based drug
addiction treatments in real-life community-based treatment settings.
The result is that science-based treatments are now more accessible to
diverse groups of patients suffering from various addictions. Patients
from across the country can now participate in the 7 research protocols
that are already being run through the National Drug Abuse Treatment
Clinical Trials Network (CTN) with another set of trials nearing the
implementation stage. Until the establishment of the CTN, researchers
and treatment providers had to rely on treatment results from studies
conducted in specialized settings with much restricted subject
populations. Through this present network of 14 research centers and
over 80 community treatment programs on the front lines of clinical
practice across the country, the CTN is engaging much of the drug abuse
community in a national effort against addiction and its consequences.
Additionally, the CTN provides a much needed infrastructure to more
efficiently and rapidly disseminate other kinds of research findings to
practitioners and patients across the country. The CTN is a major step
toward achieving NIDA's millennial goal of improving the quality of
drug addiction treatment in this country using science as the vehicle.
The network is still not complete, however. Many areas of the country
are yet to be brought into its auspices. Future plans call for the CTN
to spread out geographically which will better serve the more than 5
million individuals that the Office of National Drug Control Policy
reports are currently in need of treatment. The CTN will also serve as
a natural vehicle to reach segments of the population that have
traditionally been the least likely to access medical help, such as
minority populations, disadvantaged populations, urban and rural
communities, and others whose health care needs are unmet.
responding to ever-emerging new drug problems
Unfortunately, the overall picture of drug abuse in the United
States is constantly changing. As soon as we get a clear understanding
of drug use patterns and gain some control over existing drug problems,
new dangerous substances seem to emerge. Similar to the way a virus
mutates, both regional and national drug abuse patterns are constantly
reshaping and rarely remain static. Tried and true prevention and
treatment approaches may not work with many of the new drugs that are
emerging on the scene today. For example, newly emergent drugs like
methylenedioxymethamphetamine (MDMA or ``Ecstasy''), which acts as both
a hallucinogen and a stimulant, require new prevention and treatment
approaches, as does the unique stimulant methamphetamine. By having our
pulse on these constantly changing drug trends, NIDA is poised to use
the power of scientific research and its application to avert emerging
drug problems before they become national epidemics. Nowhere is this
proactive approach better exemplified than with the role that science
continues to play as our Nation discusses and responds to menacing
drugs like MDMA and methamphetamine. Because these club drugs were
identified early on by NIDA as potential health problems, we were able
to launch our Club Drug Research Initiative, and dissemination effort
to rapidly inform communities about these drugs. The fact that over
700,000 people have visited our dedicated website on this topic (http:/
/www.clubdrugs.gov/) since we launched it in late 1999 demonstrates the
interest that people have in receiving science based information. Not
only have we come a great distance in educating the public about these
drugs, but our science has revealed some ground-breaking findings.
Research shows that ``club drugs'' such as MDMA are far from benign
substances. MDMA has been found in animals and most recently in humans
to be neurotoxic, resulting in long-lasting or possibly permanent
damage to the neurons that release serotonin. MDMA has also been found
to impair an individual's learning and memory abilities. Accumulating
evidence shows that chronic heavy use of MDMA is associated with sleep
disorders, depressed mood, anxiety, impulsiveness and hostility, and
memory loss. These cognitive effects have been found to last even up to
six to 12 months after abstinence from the drug. Because of the
abundance of research findings that continue to emerge on this topic,
NIDA will bring leading researchers from across the globe to the NIH
campus this summer to discuss the myriad of findings and determine the
best future research directions to answer important remaining questions
about the causes and consequences of MDMA use and how best to deal with
them.
Methamphetamine, another popular club drug, has also been found to
cause neuronal damage to an individual's brain cells, similar to some
of the damage that occurs from stroke or Alzheimer's. Again, the
abnormal brain function persists well after drug use has stopped. For
example, methamphetamine abusers who were drug-free for up to eleven
months still had significant memory and coordination deficiencies that
were directly linked to brain changes produced by their prior drug use.
These alarming results have led NIDA to expand its portfolio in all
areas, with a special emphasis to look more closely at the potential
health and developmental consequences that methamphetamine use by women
of child-bearing years might have on the developing child.
neuroscience portfolio sets stage for new treatments
The convergence and application of powerful new tools and emerging
technologies are accelerating the pace of neurobiological advances and
allowing researchers to ask and answer questions that were not even
imaginable five years ago. NIDA has nearly doubled the breadth and
depth of its basic and clinical neuroscience portfolios. It has also
allowed us to use basic research as the foundation for the entire NIDA
portfolio, from prevention efforts to medications development.
One of the major new areas that NIDA will exploit in the
neuroscience arena is to build on our knowledge about how specific
brain circuits are affected by drugs of abuse, so that we can more
precisely determine how these brain pathways are impacted by chronic
exposure of drugs and how this can ultimately result in addiction. We
have learned much, but still do not completely understand what causes
an individual to make the critical transition from being able to
voluntarily use and then abstain from drugs to the uncontrollable
compulsive drug-seeking State that has become the hallmark of
addiction. An array of new technologies, such as microarrays, which can
simultaneously analyze the activity of thousands of genes, is allowing
us to better elucidate the molecular and cellular mechanisms by which
voluntary drug use can evolve over time into addiction. We will be
better able to determine what genes are being turned on and off by drug
exposure and to identify patterns of gene expression that make some
individuals more vulnerable to addiction than others. For example,
researchers found that individuals with a genetic deficiency in an
enzyme that metabolizes nicotine (CYP2A6) are less likely to start
smoking, and smoke less if they do start, than individuals with normal
CYP2A6 activity. Building on this knowledge, researchers tested more
than 200 compounds to decrease CYP2A6 activity and found that one
compound (methoxsalen) commonly used to treat skin disorders may be
helpful to people who want to quit smoking. This is just one example of
the role that genetic research can play in helping us to develop even
more novel therapeutic approaches to prevention and treatment of
tobacco smoking.
Developing new approaches for treating addiction to nicotine is an
important research endeavor for NIDA. NIDA will work both independently
and collaboratively to bring more pharmacological and behavioral
therapies for nicotine addiction to fruition. NIDA is especially
interested in developing treatments that are specifically tailored to
adolescent populations. At our Teen Tobacco Treatment Research Center
in Baltimore, for example, over 60 adolescent patients are
participating in a 3-month outpatient study that is helping to
determine the most effective methods for treating tobacco dependence in
this population. These findings will be used to improve treatment for
teens across the country.
science-based principles for drug abuse prevention
Just as NIDA has declared as our millennial goal to improve the
quality of drug abuse treatment nationwide using science as the
vehicle, we are working to do the same in the prevention arena. To
ensure that science-based prevention principles and protocols can be
effectively used by a wide variety of populations across the country
NIDA plans to launch a National Drug Abuse Prevention Trials System in
fiscal year 2002. Leading prevention researchers will be brought
together at NIDA's 2nd National Conference on Drug Abuse to discuss the
latest prevention findings and to help NIDA prioritize the most
promising prevention programs that should be initially tested in the
new System.
blending public health and public safety approaches
In the same way that we have developed and sent to the field
general principles that define effective prevention and treatment
strategies, we are working to lay out standardized principles about
duration, setting, and detailed protocols that should be used to more
effectively treat individuals while they are under criminal justice
control. Given the fact that untreated addicted criminal offenders have
extremely high rates of post-release recidivism both to drug use and to
criminality, NIDA's research can play a pivotal role in helping to
address this public health and public safety issue. As we continue to
learn about how to improve treatment outcomes and how to reduce the
risk of relapse for patients undergoing treatment, NIDA will use this
knowledge to work with the Department of Justice and others to improve
the treatment of addicted criminals, particularly those with co-
occurring mental disorders.
science leads our national discourse
Scientific advances continue to come at a tremendous pace and are
not only improving the health and quality of life for our citizens, but
are changing how we as a Nation view and approach addiction.
Understanding initial drug use as a voluntary, and thus preventable,
behavior; and understanding addiction to be a treatable, often chronic
and relapsing disease of the brain, forces us as a Nation to adopt an
even more sophisticated approach to dealing with this nation's drug
problems. Having science set the stage for our course of action,
including furthering the blending of public health and public safety
approaches, is clearly the best way to reduce the enormous financial
and social burden of drugs on our society. There are indicators at all
levels, Federal, State and local, that this is in fact occurring. NIDA
will continue to provide the latest science-based information to ensure
the national discourse on this topic proceeds. We will also continue to
ensure that new findings rapidly reach local communities. Science
brings us all renewed hope and confidence for a healthy and prosperous
future. It is NIDA's role to ensure that this hope for the future is
fully realized.
government performance and results act (gpra)
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 second annual performance report which
compares our fiscal year 2000 results to the goals in our fiscal year
2000 performance plan. As performance trends on research outcomes
emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
______
Prepared Statement of Dr. Yvonne T. Maddox, Acting Deputy Director,
Office of the Director, National Institutes of Health
Mr. Chairman, Members of the Committee: I am pleased to present the
President's budget request for the Office of the Director (OD) for
fiscal year 2002, a sum of $232,098,000, which reflects an increase of
$44,552,000 over the comparable fiscal year 2001 appropriation. 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 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.
the office of aids research
The Office of AIDS Research (OAR) plans, coordinates and evaluates
the NIH HIV/AIDS research activities; serves as the focal point for
AIDS policy and budget development; and coordinates NIH involvement in
international AIDS research activities.
OAR develops an annual comprehensive AIDS research plan and budget
for all NIH sponsored AIDS research, based on the most compelling
scientific priorities that will lead to better therapies and prevention
of HIV infection and AIDS. These priorities are determined through a
unique and collaborative process involving the NIH Institutes and non-
government experts from academia and industry, with the full
participation of AIDS community representatives.
The OAR also administers a discretionary fund and supports the
Intramural AIDS Targeted Antiviral Program (IATAP) and the AIDS
Research Loan Repayment Program (LRP). The budget request includes
$53.5 million for OAR activities in fiscal year 2002.
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 2002, the OD budget request includes an increase of $28
million for ORWH to pursue the recommendations within this agenda
including research on chronic diseases in women, support for
reproductive health research, research to aid in the prevention and
detection of cervical cancer and ovarian cancer, studies to develop
gender-based treatments for diabetes and kidney disease, and studies
that address prevention and elimination of lung cancer in women. In
addition, the ORWH, with NIH Institutes and the Agency for Health
Research and Quality (AHRQ), 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.
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. The Office of
Behavioral and Social Sciences Research (OBSSR) furthers the mission of
NIH by emphasizing the role that behavioral and social factors play in
health. The fiscal year 2002 OD budget includes $23.7 million for
OBSSR, an increase of $3 million, or 15.7 percent, over fiscal year
2000. 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
(ICs). OBSSR has addressed one of the Nation's most troubling health
concerns--youth violence. A special panel of experts found that there
is a need for interventions to prevent and treat youth violence, as
well as for studies that would improve service delivery and maintain
behavioral change. OBSSR, with four Institutes, initiated a Request for
Applications (RFA) entitled, ``Research on the Development of
Interventions for Youth Violence,'' to focus on these needed areas of
research.
Child neglect is one of the most critical areas of research when
focusing on the well-being of children, and a topic about which little
is known. OBSSR authored both a RFA and a Program Announcement (PA) for
this activity along with six NIH Institutes; the Agency for Children,
Youth, and Families (ACYF); The Department of Justice (DOJ), and the
Department of Education. Both the RFA and the PA encourage research to
enhance understanding of the causes, extent, treatment, management, and
prevention of child neglect.
Enhancing opportunities to collaborate and form partnerships is an
important component of the OBSSR strategic plan. OBSSR is currently
collaborating with the Association of American Medical Colleges (AAMC)
to explore the development of a curriculum for behavioral and social
sciences relevant for medical schools. 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 address the problem of inadequate
adherence to prescribed medications and therapies.
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 2002, the Office of Dietary Supplements (ODS) will
continue to promote the scientific study of the use of dietary
supplements. The Office will continue to support investigator-
initiated research through the Research Enhancement Awards
Program (REAP) and through PAs with other ICs at NIH. The
Office will also stimulate research through conduct of
conferences, workshops, and presentations at national and
international meetings.
--In continuing efforts to inform the public about the benefits and
risks of dietary supplements, the ODS expanded the
International Bibliographic Information on Dietary Supplements
(IBIDS) database to include a consumer-oriented search
strategy.
--ODS is nearing completion of public-oriented information pages
(Fact Sheets) about specific vitamin and mineral dietary
supplements for wide dissemination in print and on the
Internet. These are to be followed by a series of Fact Sheets
for botanical and herbal supplements which are being developed
in conjunction with the National Center for Complementary and
Alternative Medicine (NCCAM).
--To determine the effects and safety of dietary supplements
containing ephedra, ODS, with other Federal partners, will
conduct an evidence-based review of ephedra efficacy and
safety; and will nominate ephedra for study by the National
Toxicology Program of the National Institute of Environmental
Health Sciences.
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 ORD, with the National Human Genome Research Institute (NHGRI),
plans to release a Request for Proposals (RFP) to establish an
information center to respond to requests received by the NIH for
information about rare and genetic disorders.
The ORD is also planning to respond to the critical needs of
patients with rare, life-threatening diseases by establishing a
diagnostic center of excellence for patients whose previous diagnoses
have been elusive despite extensive prior efforts to determine the
exact nature of their illnesses. The center would foster research on
rare diseases, develop facilities designed specifically for rare
diseases research, and would eventually support investigator training
focusing on rare diseases.
OTHER OD ACTIVITIES
The OD also supports a number of additional NIH programs that
promote research and enhance research career development:
--The NIH, through the 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 request also contains funds
for the implementation and administration of two new NIH
clinical loan repayment programs, the Extramural Clinical
Research Loan Repayment Program and the Pediatric Research Loan
Repayment Program.
--The Office of Science Policy (OSP) has a role in addressing science
policy issues on behalf of NIH and in coordinating NIH's
approach to the Government Performance and Results Act (GPRA).
In addition, the OSP has developed, with the ICs, 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 request also reflects several functional transfers, including
the transfer of funding for bioengineering and bioimaging
activities to the National Institute of Biomedical Imaging and
Bioengineering (NIBIB); funding for the Extramural Loan
Repayment Program transferred to the National Center for
Minority Health and Health Disparities (NCMHD); funding for the
Extramural Associates Program (EAP) and the Extramural
Associates Research Development Award (EARDA) Program to the
National Institute of Child Health and Human Development
(NICHD); and the transfer of the Academic Research Enhancement
Award (AREA) funding to the several ICs supporting these
awards.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
Thank you for giving me the opportunity to present this statement;
I will be pleased to answer questions.
______
Prepared Statement of Dr. Jack A. McLaughlin
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request of the National Eye Institute (NEI) for
fiscal year 2002, a sum of $571.1 million, which reflects an increase
of $60.5 million over the comparable fiscal year 2001 appropriation.
Diseases of the eye and disorders of vision can have a profound
affect on the quality of our lives. Many of them are chronic, disabling
diseases and conditions that may ultimately lead to visual impairment
or blindness. The National Eye Institute and the scientists it supports
are committed to improving the visual health of our citizens. The
research that they perform in this pursuit touches upon every area of
scientific endeavor and every facet of the visual system.
RETINAL DISEASE RESEARCH
The retina is the transparent, light-sensitive tissue that lines
the back of the eye. Diseases and disorders of the retina and its blood
supply account for much of the blindness and visual disability in this
country. The most important of these include macular degeneration,
diabetic retinopathy, retinitis pigmentosa and related disorders,
retinal detachment, uveitis, and cancer (choroidal melanoma and
retinoblastoma).
NEI-sponsored scientists are actively pursuing laboratory and
clinical studies on the development, molecular and cell biology,
molecular genetics, and metabolism of the photoreceptor cells that
capture light; the initial neural processing of information that is
transmitted to the visual centers of the brain; the pathogenesis of
diabetic retinopathy; the fundamental causes of and etiologic factors
responsible for uveitis; the identification of the genes and
neurodegenerative mechanisms for macular degeneration, retinitis
pigmentosa, and related disorders; and the cellular and molecular
events that accompany retinal detachment. The ultimate goal of these
studies is to develop effective therapeutic or preventive measures
where none currently exist or to improve those treatments that are
currently available.
CORNEAL DISEASE RESEARCH
The cornea is the transparent tissue at the front of the eye that
plays an important role in refracting or bending light to focus visual
images sharply on the retina. Because the cornea is the most exposed
surface of the eye, it is especially vulnerable to damage from injury
or infection. The leading causes of corneal blindness are herpes and
other infections, corneal opacification or clouding, and inherited and
degenerative diseases. The NEI supports laboratory and clinical studies
on a wide range of research topics, including: the regulation of genes
that express proteins unique to corneal tissue; the characterization of
specific proteins and cell surface receptors that interact with corneal
cells, pathogens, and blood-borne cells; the mechanisms that maintain
corneal hydration and transparency; the physiologic basis for immune
privilege in the cornea; corneal wound healing; the cellular and
molecular mechanisms by which corneal transplants are rejected; and the
role of specific viral genes in the establishment and reactivation of
corneal herpetic infections. These studies should ultimately improve
our ability to limit or prevent damage to corneal clarity caused by
injury, infection, or other disease processes.
CATARACT RESEARCH
A cataract is an opacity of the eye's normally clear lens that
interferes with vision. Cataract may develop at any time during life,
although it is most often associated with advancing age. In addition to
aging, cataract may be a consequence of diabetes and other metabolic
disorders, trauma, exposure to ionizing radiation, or it may be
inherited or congenital in nature. Cataract treatment in this country
is one of the most successful of all surgical procedures. At this time,
surgery to remove the opaque lens is the only effective way of treating
cataract.
The NEI-sponsored research includes: studies of the development and
aging of the normal lens of the eye; the identification, at the
cellular and molecular level, of those components that maintain the
transparency and proper shape of the lens; the control of lens cell
division and differentiation; the delineation of the structural and
regulatory sequences of crystallin and noncrystallin lens genes; and
the impact of continual oxidative insult on the lens. The aim of this
research is to develop the means to delay or prevent cataract
formation.
GLAUCOMA RESEARCH
Glaucoma is a group of disorders that share a distinct type of
optic nerve damage that can lead to blindness. Glaucoma is often
associated with increased pressure within the eye caused by inadequate
drainage of aqueous humor, the fluid within the eye that nourishes the
cornea and lens. Researchers once thought that glaucoma resulted solely
from increased pressure, but they now know that the elevation in the
pressure within the eye is only one of the risk factors for the
disease. Although glaucoma is primarily a chronic disease of aging, it
may occur at any age. It can occur as a primary disorder or it can be
secondary to other ocular or systemic conditions. Because glaucoma is a
major health problem and the number one cause of blindness in African-
Americans, it is a primary focus for NEI's research on health
disparities. Approximately three million Americans have glaucoma, with
about half of these unaware that they have the disease. As many as
120,000 are blind from this disease.
The NEI supports clinical trials that assess the role of medical
and surgical therapy in the treatment of the disease. One study, the
Ocular Hypertension Treatment Study, is attempting to determine the
benefit of treating people with elevated pressure in their eyes who are
at moderate risk for developing glaucoma with pressure lowering
medications to prevent or delay sight-threatening damage to the eye
from glaucoma. The NEI also supports studies on the identification and
characterization of genes that are involved in the development of
glaucoma and the basic mechanisms that control fluid secretion and
outflow and the design of methods to control these processes and to
protect the optic nerve from damage.
STRABISMUS, AMBLYOPIA, AND VISUAL PROCESSING RESEARCH
Research on strabismus and amblyopia encompasses a broad range of
clinical and laboratory studies on the structure and function of the
neural pathways from the retina to the brain, the central processing of
visual information, visual perception, the control of ocular muscles,
and refraction. A large number of congenital, developmental, and
degenerative abnormalities affect the visual sensorimotor system, but
three disorders are of primary concern: strabismus or the misalignment
of the eyes; amblyopia, or lazy eye, in which one eye has reduced
vision due to misalignment or unequal refraction; and refractive
errors, especially myopia (nearsightedness), hyperopia
(farsightedness), and presbyopia (difficulty focusing on near objects
with advancing age).
As a means of improving the visual health of those afflicted with
these conditions, the NEI supports a broad range of laboratory,
therapeutic, and preventative studies that are concerned with the
development and function of the neural pathways from the eye to the
brain; the central processing of visual information; visual perception;
optical properties of the eye; oculomotor function; functioning of the
pupil; and control of the ocular muscles. Additional emphasis is on
research on optic neuropathies, eye movement disorders, and the
development of myopia.
VISUAL IMPAIRMENT AND ITS REHABILITATION
Each of the chronic diseases and disorders previously described can
cause blindness and lesser degrees of visual impairment that may also
be disabling. As a means of addressing the special needs of those with
uncorrectable visual impairment or low vision, the NEI supports a
program of research on visual impairment and its rehabilitation. Some
individuals require simple optical or mechanical aids to perform daily
functions adequately, while others may need more specialized devices or
modifications to their environment. Many face depression as they deal
with their loss of vision and potentially their loss of independence.
The NEI supports research to understand the origins of visual
impairment and assist in the rehabilitation of those who have such
disabilities. The NEI supports projects aimed at improving the methods
of specifying, measuring, and categorizing loss of visual function;
devising strategies to help visually impaired people maximize the use
of their residual vision; systematically evaluating new and existing
visual aids; developing an adequate epidemiological base to understand
the causes of blindness, partial loss of sight, and visual anomalies;
and studying the optical, electronic, and other rehabilitative needs of
people with visual impairments.
HEALTH EDUCATION AND COMMUNICATION
The NEI's National Eye Health Education Program (NEHEP) was
developed to increase awareness among health care professionals and the
public of scientifically based health information that can be applied
to preserving sight and preventing blindness. Working through its
partnership of over 50 professional and voluntary organizations, which
includes some of the other NIH Institutes, the NEHEP attempts to reach
select target audiences, informing them of the importance of early
detection and treatment of eye diseases, particularly glaucoma and
diabetic retinopathy, and persuading them to make an appropriate change
in behavior.
To increase awareness of low vision and its impact on quality of
life, NEHEP developed the Low Vision Education Program. This program is
directed toward people with low vision, their families and friends, and
the health care and service professionals who care for them. It takes
particular note of the growing population of people over age 65 and
other high risk populations, including Hispanics and African Americans
who are likely to develop low vision at an earlier age. As part of this
education effort, the NEI has developed a public service campaign and a
mobile exhibit on low vision that is currently traveling to shopping
malls and centers throughout the United States. The exhibit consists of
five colorful kiosks designed to attract a cross section of the
population. It contains an interactive multimedia touchscreen program;
provides information on low vision services and resources; and displays
aids and devices that help people with low vision, all available in
Spanish as well as English. The exhibit and touchscreen program explain
the causes of low vision; offer personal accounts of people living with
low vision; and provide a self-assessment to help people determine if
they or someone they know may have low vision.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
Mr. Chairman that concludes my prepared statement. I would be
pleased to respond to any questions you or other members of the
committee may have.
______
Prepared Statement of Kenneth Olden, Director, National Institute of
Environmental Health Sciences
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of
Environmental Health Sciences (NIEHS) for fiscal year 2002, a sum of
$561,750,000, which reflects an increase of $58,668,000 over the
comparable fiscal year 2001 appropriation.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
GENES AND THE ENVIRONMENT
Over the past 100 years, advances in biomedical research have led
to remarkable improvements in the prevention, diagnosis, and treatment
of human illness. Life expectancy has increased from an average age of
49 years at the turn of the century to the current average of 76.
Continued improvements in quality of life and longevity will require a
better understanding of the development and progression of common
diseases. Identification of the major determinants of human health is
one of the major challenges of the 2lst century.
Scientists in biomedicine, environmental health, and public health
are working to understand and prevent human diseases. Most chronic
diseases in humans arise from a complex array of factors which could
include several genes, environmental conditions or exposures, the age,
nutritional status or stage of development of a person, and other
predisposing factors. The relationship between genes and the
environment can be compared to a loaded gun and its trigger. A loaded
gun by itself causes no harm; it is only when the trigger is pulled
that the potential for harm is released. Genetic susceptibility creates
an analogous situation where the loaded gun is one or a combination of
susceptibility genes and the trigger is an environmental exposure. One
can inherit a predisposition to have a disease, but never have the
disease unless exposed to the environmental trigger. Therefore, most
chronic diseases will not be fully understood until both the genetic
and environmental contributions to their etiology are elucidated.
Unfortunately, the relationship between genes and the environment is
neither well understood nor extensively studied at the present time.
Until recently, limited and inadequate knowledge of human genetics had
hampered progress in this area and had limited scientists to relatively
simplistic models-models that assume that diseases are caused by
mutations in a single gene or by exposure to a single environmental
agent. Interactions between multiple genes, or between genes and
several environmental agents, have only been rarely considered as the
cause of human illness. So our knowledge has many information gaps.
To develop the framework that will allow us to accurately assess
environmental threats to human health-threats that affect us from
conception to death-we need to fill in the missing information in at
least three areas. We need:
--information relating to toxicity for environmentally significant
compounds from well-characterized animal models tested at
biologically relevant doses;
--a comprehensive catalogue of human gene variation that can
influence susceptibility to environmental exposures;
--extensive epidemiological and other population-based studies that
can definitely link human disease to environmental exposure.
ASSESSMENT OF TOXICITY/CARCINOGENICITY
Estimates are that 70-75 percent of the high-volume, high-use
chemicals (15,000) in commercial use in the United States have not been
assessed for human toxicity or carcinogenicity (National Academy of
Sciences, 1980; Environmental Defense Fund, 1993). While many, if not
most, of these may not require testing since they are very similar to
chemicals already tested, several do need testing. But, given the sheer
magnitude of the problem, we can never satisfy this testing requirement
using traditional technologies. For example, the National Toxicology
Program only recently celebrated the completion of carcinogenicity
assessments of 500 chemicals after 30 years of operation. The time-
honored way of determining which of the thousands of environmental
agents are toxic to humans is to expose hundreds of animals to the
suspected product and observe them for adverse health outcomes (e.g.,
cancer or developmental anomalies). These studies take years to
complete, cost millions of dollars, use hundreds of animals, and are
not sufficiently informative.
Now, however, we have new tools generated by advancements in the
science of genomics; that is, the study of our genes and what they do.
These tools offer unprecedented ways to understand biological and
disease processes at the molecular level. The NIEHS is merging the
field of toxicology with genomics, creating a science of toxicogenomics
that identifies toxicant activity at the genetic and molecular level.
Last November, the NIEHS developed a National Center for Toxicogenomics
to promote a genomics-based approach for assessing the toxic or
carcinogenic potential of environmental agents. Using this approach,
one can survey the entire human genome in just a few days to determine
the response of various tissues or organ systems to specific
environmental exposures. Rather than using pathology to identify
illness, the toxicogenomics approach relies on gene expression profiles
or signature patterns to determine which agents are toxic or
carcinogenic. Current experience with this rapidly evolving technology
has validated its potential usefulness in that various classes of toxic
agents give rise to unique signature patterns (i.e., gene expression
profiles) characteristic of specific disease pathways.
To promote the development and validation of the gene expression
profiling approach, the NIEHS has established five university-based
regional centers with the NIEHS intramural program serving as a data
repository and coordinating center.
SEARCH FOR ENVIRONMENTAL SUSCEPTIBILITY GENES
Organisms and species are exposed to hazardous agents in the
environment on a continual basis. As a result, sophisticated metabolic
pathways have evolved that can minimize the biological consequences of
hazardous environmental agents. These pathways constitute the so-called
``environmental response machinery.'' All human genes, including those
that encode components of the environmental response machinery, are
subject to genetic variability, which can be associated with altered
efficiency of a biological pathway. So a person's risk for developing
an illness as a result of an environmental exposure might be dependent
on the efficiency of his or her own unique set of environmental
response genes. These genes, for example, might determine how a person
responds to and metabolizes drugs or carcinogenic compounds after
exposure.
The Environmental Genome Project was initiated in 1997 to stimulate
population-based and other research into the role of genetic variation
in response to environmental exposure. The key objective is to identify
all the genes in the human genome that confer susceptibility to
environmental agents. The NIEHS is supporting five university-based
centers to resequence suspected or candidate environmental
susceptibility genes to identify genetic variations responsible for
differences in response to environmental agents leading to specific
diseases.
Presently, environmental health regulatory agencies craft rules as
if ``one-size-fits-all.'' However, we know that individuals can vary by
more than two-thousand fold in their capacity to repair or prevent
damage following exposure to toxic agents in the environment. For
example, several people died after members of the Aum Shinrikya cult
released potent nerve gas called sarin in a Tokyo subway station about
six years ago; not all those exposed, however, died. We now know that
some humans are much more vulnerable to sarin poisoning than others.
Circulating in the blood of 25 percent of Asians and 10 percent of
Caucasians is a version of an enzyme called paraoxonase that converts
sarin to a less toxic chemical about 10 times more quickly than the
enzyme found in most people. The gene that produces paraoxonase is one
of dozens that toxicologists think make some individuals more or less
susceptible to the effects of pollutants and other environmental
chemicals (e.g., organophosphate pesticides), contributing to adverse
health outcomes such as cancer, asthma, birth defects, diabetes,
cardiovascular disease, Parkinson's and Alzheimer's. So, scoring for
variations in a person's genetic code can help determine the likelihood
that an individual will have an adverse response from exposure to sarin
or other environmental agents. Knowledge of the prevalence of
susceptibility genes would take much of the guesswork out of
environmental health decision-making.
GENETIC VARIABILITY, EXPOSURE, AND DISEASE ASSOCIATION
To study the functional implications of genetic polymorphism or
variation relative to specific environmental exposures and disease
development, better exposure data will be required. 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
understanding of dose-response relationships and 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. Actual exposure is
highly variable for individuals and subpopulations. It is really a
function of individual uptake, metabolism, excretion and behavior. So
the assumption that all men, women and children 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.
The NIEHS is spearheading an interagency effort to intensify exposure
assessment research. We have been working with Centers for Disease
Control and Prevention to expand the types of toxicants measured in
samples collected thru National Health and Nutrition Examination Survey
(NHANES) such as those recently reported in the National Report on
Human Exposure to Environmental Chemicals. These and future efforts are
expected to strengthen what is often viewed as the weakest link in the
risk assessment process.
The effects of exposure are not just limited to individual
chemicals. Typically, toxicity and carcinogenicity are assessed in
animals one chemical at a time, and the risk for each chemical in the
mixture is added up to get a total risk. Implicit in summing up the
risks is the assumption of independent, not interactive but additive,
effects. This assumption is controversial. Also, this contrasts with
the ``real world'' where humans are exposed to multiple agents-
chemical, physical and biological-at any given time in the form of
mixtures. We are aware of situations where current assumptions do not
hold in that components of mixtures behave synergistically. We now have
the capacity to develop technology to assess the toxicity of mixtures.
One promising technology being developed with the NIEHS support is the
DNA microarray gene expression profiling approach described above.
SUMMARY
Much of 20th century medicine focused on managing endstage diseases
rather than preventing them at the outset. Yet prevention is the most
cost-effective and life-enhancing means we have to protect human health
at every life stage. In the past, the environmental health sciences,
where prevention is the goal, lacked the necessary tools to identify
important disease triggers. Now, however, the Nation's long-term
investment in the basic sciences has put us in the position to fill the
knowledge gaps. We are poised to more efficiently and more precisely
identify the environmental components that set the stage for disease
initiation and progression.
______
Prepared Statement of Audrey S. Penn
Mr. Chairman and Members of the Committee: I am Audrey Penn, Acting
Director of the National Institute of Neurological Disorders and
Stroke. I am pleased to present the President's budget request for
NINDS for fiscal year 2002, a sum of $1,316,448,000, which reflects an
increase of $139,428,000 over the comparable fiscal year 2001
appropriation. 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 second
annual performance report which compares our fiscal year 2000 results
to the goals in our fiscal year 2000 performance plan. As performance
trends on research outcomes emerge, the GPRA data will help NIH to
identify strategies and objectives to continuously improve its
programs.
The mission of NINDS is to reduce the burden of neurological
disorders. Today I will speak briefly about that burden. I will also
say a few words about the progress so far in treating these diseases
and the remarkable opportunities presented by recent scientific
advances. However, I will spend most of my limited time telling you
what NINDS is doing to ensure that science is translated as quickly as
possible into help for people with neurological disorders.
THE BURDEN OF NEUROLOGICAL DISORDERS
Disorders that affect the brain, spinal cord, nerves of the body,
muscles and their control impose an enormous toll on society.
Neurological disorders can compromise the complex thinking and emotions
that make us human, the routine perception and movement that we take
for granted, and even the control of bodily systems that are normally
beneath our conscious awareness. Trauma, infections, toxic exposure,
birth defects, degenerative diseases, tumors, gene mutations, systemic
illness, vascular events, nutritional deficiencies, and adverse effects
of essential treatments for diseases like AIDS and cancer can all
disrupt the functions of the nervous system.
We often think first of neurological disorders that afflict older
Americans-stroke, Alzheimer's, Parkinson's. But problems like multiple
sclerosis, brain and spinal trauma usually strike young adults, and the
list of childhood disorders is enormous-autism, cerebral palsy,
Duchenne muscular dystrophy, Batten disease, Canavan disease, to name
just a few. Disorders like epilepsy and brain tumors, which can strike
at any age, also occur frequently.
Some neurological disorders are very common. NINDS and American
Heart Association studies show that more than 700,000 Americans suffer
strokes each year. The Centers for Disease Control and Prevention
estimates that head trauma kills more than 50,000 people each year and
more than five million survivors suffer disabilities. Physicians tell
us that pain is the most common symptom that brings people to a doctor.
A recent journal from the American Academy of Neurology, for example,
suggests that migraine headaches affect about twenty percent of women.
Diabetic neuropathy commonly accompanies diabetes. Epilepsy, autism,
cerebral palsy, dystonia, the neurological aspects of AIDS and several
other disorders also affect many people.
Collectively the hundreds of rare disorders of the nervous system
also affect many people and their families. The history of medicine
teaches us that studying rare diseases often has wide repercussions.
Creutzfeldt-Jakob disease (CJD) is a terrible disorder that strikes
about one in a million people. The long tradition of NINDS research on
this formerly obscure disease is now coming to the forefront because of
the public health concerns raised by the related bovine spongiform
encephalopathy (BSE or ``mad cow disease''). In the last year NINDS
initiated a contract program to develop tests needed for confronting
the public health and economic threats from BSE. Rare disorders often
provide clues to more common diseases, and CJD is a good example here
too. Abnormal aggregation of proteins called prions are at the crux of
CJD. Abnormal clumps of other proteins have also been implicated in
common diseases such as Parkinson's, Huntington's, and Alzheimer's.
PROGRESS AND PROMISE IN NEUROLOGICAL DISEASES
Perhaps because the brain is so complex and inaccessible,
neurological disorders have always been among the most difficult to
treat of all medical problems, but we are making progress. The American
Heart Association estimates that the death rate from stroke went down
by 14 percent from 1987 to 1997. NIH is continuing prevention trials
that have contributed to that decline. In the 1990's NINDS clinical
trials demonstrated the first acute treatment that improves outcome
from stroke, the drug t-PA, and the first emergency drug treatment that
can reduce the disability from spinal cord injury, high dose
methyprednisolone. Neurosurgeons have developed guidelines that can
improve outcome from head trauma. The first treatments that reduce
symptoms and even slow progression of multiple sclerosis have emerged
from studies of the nervous and immune systems. Several new drugs for
epilepsy are now available, partly through efforts of the NINDS drug
development programs. New surgical treatments, such as chronic deep
brain stimulation, show promise for Parkinson's and other disorders. We
have new genetic tests that help diagnose inherited neurological
disorders. Clearly we are making progress, and much of that progress
rests on the stream of advances from basic neuroscientists which is
continuing. But each example represents only the first steps toward
adequate treatments and prevention. We have a long way to go.
What is most encouraging is the range of new therapeutic strategies
on the horizon. It may seem peculiar, but one important step in
learning how to prevent or cure a disease is to first learn how to
cause it. The striking progress in understanding the nervous system and
its diseases at the level of genes, proteins, cells and brain circuits,
is bringing us long sought after animal models of human disorders.
Animal models enable scientists to follow the course of disease
progression, refine understanding of causes, and develop therapies.
Discovery of the genes responsible for inherited disorders such as
Batten disease, ataxias, spinal muscular atrophy, and muscular
dystrophy often leads to animal models of these disorders. Finding the
genes responsible for uncommon inherited forms of Alzheimer's,
Parkinson's and amyotrophic lateral sclerosis (ALS) has led to animal
models that will foster progress against the more common non-inherited
versions of these disorders. Genes are not the only route to developing
animal models. This year brought new models for neurodegeneration in
Parkinson's disease through use of a pesticide, rotenone, as well as
through manipulation of genes; surgical techniques have always been
important for developing animal models of stroke and trauma; and
immunological approaches are important in diseases such as multiple
sclerosis.
Using animal models, researchers are exploring the potential of
cell transplantation, gene transfer, natural biochemicals, electrical
stimulation, and new approaches to drug therapy for treating
neurological disorders. Researchers using gene transfer vectors to
deliver the natural neurotrophic (growth and survival) chemical GDNF
were able to counter some Parkinson's-like effects in animals. Gene
transfer also has shown promise in mice with the same gene defect as
boys with Duchenne muscular dystrophy, and strategies to repair
defective genes also now appear plausible for this disease. Cell
transplantation in animals has helped repair damage from spinal cord
injury, restore the myelin insulation of nerve fibers that is lost in
multiple sclerosis, provide missing enzymes in inherited disorders like
Tay-Sachs disease, and replenish the chemical dopamine in Parkinson's
disease. Study of the steps in ``cell suicide'' that occurs as the
simple nervous system of the worm develops led to the recognition that
similar cell death mechanisms play out in several neurological
disorders. Blocking steps in this cell death program has shown benefits
in animal models of stroke, trauma, Huntington's disease and ALS. This
is only a sampling, but shows that not far over the horizon are
possibilities for treating many neurological disorders.
WHAT IS NINDS DOING TO MOVE TOWARD CURES?
The genius of the NIH system is its power to engage the collective
wisdom and ingenuity of the nation's scientific community. We must
continue to nourish those ongoing efforts and position ourselves
prudently to continue to support that base upon which all our efforts
rest. At the same time, the scientific progress compels us to target
efforts toward translating the scientific potential into real help for
people as quickly as possible, and the recent funding increases empower
us to do so. The key is again to rely upon the distributed insight of
the medical and scientific community.
NINDS has a multi-tiered planning process to harness that
collective wisdom to meet our mission. The planning process brings
together scientists, physicians, the advocacy community, industry, and
NIH staff in several complementary ways. We began, about two years ago,
by convening more than 100 leaders from the scientific community,
together with patient-advocates and NINDS staff, to assess needs,
opportunities and priorities in several cross-cutting areas, each
relevant to progress against many disorders. Seven panels focused on
Neurogenetics; Neurodegeneration; Channels, Synapses, and Circuits;
Cognition and Behavior; Neurodevelopment; Plasticity and Repair; the
Neural Environment; and Experimental Therapeutics and Clinical Trials.
NINDS posted draft panel reports on the internet and solicited comments
from more than 250 patient advocacy groups and professional scientific
organizations. This input helped shape the NINDS strategic plan
``Neuroscience at the New Millenium.'' which serves as a foundation for
all our planning efforts.
Building on the strategic goals, we have begun a series of disease
specific planning efforts, beginning with Parkinson's disease. A
January 2000 workshop brought together intramural, extramural, and
industry scientists, Parkinson's disease advocates, and ethicists,
forming the basis for the ``NIH Parkinson's Disease Research Agenda,''
submitted to Congress in March of last year. NIH is vigorously
implementing the Agenda. We held several workshops focused on specific
aspects of Parkinson's disease research, such as drug therapies, gene
therapies, cognitive and emotional aspects, and environmental
influences. Including solicitations issued shortly prior to the Agenda
or nearing release, NIH has developed more than a dozen requests for
grants or contracts that target specific Agenda priorities. Targets of
opportunity include deep brain stimulation, clinical trials for
neuroprotective drugs, and proteins implicated in the disease. We have
supplemented existing grants to expedite work on high throughput drug
screening, bringing new investigators to the field, and genetics of
Parkinson's in minority ethnic groups. Working groups or consortia have
formed in critical areas, such as deep brain stimulation. NINDS is also
continuing to support the eleven Udall Parkinson's disease research
centers. The Institute will soon launch a website that will set the
standard for informing the public about progress in implementing a
disease specific research plan, and also serve as a resource for
researchers and caregivers.
Several other disease specific planning efforts are also underway.
As a joint undertaking NCI and NINDS brought together a Progress Review
Group on Brain Tumors. More than 100 experts in several scientific and
medical disciplines with a bearing on brain tumors presented
assessments of current understanding and future needs in 14 critical
areas. NINDS and NCI are working to implement these recommendations. A
Progress Review Group in Stroke is following a similar process. Last
spring's landmark conference ``Curing Epilepsy: Focus on the Future''
launched efforts that developed ``benchmarks'' for epilepsy research
which are the first step towards a research agenda. This spring the
Institute of Medicine of the National Academy of Sciences released an
assessment of current status of research on multiple sclerosis with
recommendations for future research. This effort, which included NIH
researchers, will inform future efforts on this disease. Disease
specific planning efforts dovetail with the NINDS strategic plan,
revealing elements in common for many diseases and those unique to each
disorder.
Health disparities has also been a focus of specific planning
efforts at NINDS. Since fiscal year 1999 NINDS, working together with
NCRR, the ORMH and other Institutes, has expanded its original center
at Morehouse School of Medicine to eight specialized neuroscience
research programs at minority institutions and a network of research
consortia at 28 leading neuroscience research programs. NINDS is
expanding activities of this program with a parallel development of
other research as an integral part of the Institute plan for addressing
health disparities.
Another aspect of NINDS planning efforts is an active agenda of
scientific workshops, often held in cooperation with private groups and
with other components of NIH, such as the Office of Rare Diseases.
NINDS holds about 40 of these meetings each year. Some focus on
specific therapeutic strategies or technologies, such as neural
prostheses, gene therapy, optical imaging, computational neuroscience
and high throughput drug screening. Others target specific diseases.
Recent workshops focused on Duchenne muscular dystrophy,
facioscapulohumeral muscular dystrophy, hereditary spastic paraplegias,
spinal cord injury, ALS and spinal muscular atrophy, channelopathies,
neurofibromatosis, and pediatric stroke. At these workshops, in
addition to the scientific discussions, NINDS solicits advice on how to
eliminate bottlenecks and encourage progress.
I could describe many other planned and ongoing activities, and
certainly more exciting science, but I want to conclude with a simple
message. Because NINDS has an ``acting'' director does not mean the
Institute will be less active until a permanent director is appointed.
Given the burden of neurological disorders, the scientific
opportunities, and the favorable funding environment, it would be
unconscionable for the Institute to become passive. I assure you we are
doing everything we can to move aggressively toward better ways to
treat and prevent neurological disorders.
Thank you. I would be happy to answer questions.
______
Prepared Statement of John Ruffin, Ph.D., Director, National Center on
Minority Health and Health Disparities
Mr. Chairman and Members of the Committee: I am honored to appear
before you as the new Director of the National Center on Minority
Health and Health Disparities (NCMHD) to present the President's budget
request for fiscal year 2002, a sum of $158.425 million, which reflects
an increase of $26.356 million over the comparable fiscal year 2001
appropriation.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The Secretary for Health and Human Services approved the NCMHD on
January 16, 2001, as called for in Public Law 106-525. Within the
National Institutes of Health, the NCMHD serves as the focal point for
planning and coordinating minority health and other health disparities
research. The Center coordinates the development of a comprehensive
health disparity research agenda that identifies and establishes
priorities, budgets, and policy that govern the conduct and support of
all NIH-sponsored minority health and other health disparities research
and training activities. Significant progress has been made since the
establishment of the Center; however, considerable work remains to be
done as the Center transitions from an Office to a Center and assumes
grant review, funding and financial management functions. The
development of a comprehensive research portfolio began with the NIH
Office of Research on Minority Health and will be expanded to include
the medically underserved and other health disparity groups as
designated by the Agency for Health Care Research and Quality. As a
part of its mandate to build capacity for minority health and health
disparities research, the Center also will expand it's support of
training and the development of research infrastructure at Minority
Serving Institutions.
The complexity of the disparity in health status relates to
convergence of multiple factors in unsuspecting ways to cause
differences in disease progression and in health outcomes. If one tried
to identify a priori all of the factors that could potentially impact
the overall health of an individual, the results would look something
like the attached schema. Accordingly, the Center will promote and
increase participation in minority health and health disparities
research by expanding the number of investigators involved in such
research and by providing sustained funding for a wide breadth of
studies--basic, clinical, and population research; studies on the
influences of health processes; and research on the societal, cultural,
and environmental dimensions of health--all aimed at identifying
potential risk factors for disparate health outcomes.
LEVERAGING RESOURCES WITH THE NIH INSTITUTES AND CENTERS
The NCMHD will continue to provide funding support to assist the
NIH Institutes and Centers (ICs) in the following ways: piloting new
health disparities programs, improving recruitment and retention in
clinical trials, and in providing competitive supplements to expand the
focus of existing programs. The Center also will share in the support
of selected targeted studies that are supported by the NIH ICs.
Selected examples of the ways in which the Center leverages its funds
with the NIH ICs are provided below.
The Jackson Heart Study (JHS), a targeted study co-supported by the
National Heart, Lung, and Blood Institute and the NCMHD, is an
investigation of the causes of the high rate of cardiovascular disease
in the State of Mississippi. The objectives of the JHS are to: identify
risk factors for the development and progression of CVD; build research
capacity in a minority serving institution; and expand minority
participation in CVD epidemiology research. Initial examinations among
the JHS cohort began in the fall of 2000 and will take 3 years to
complete. Some of the newer areas of focus will include early
indicators of disease, genetics, sociocultural influences such as
socioeconomic status and discrimination, and physiological relations
between common disorders such as high blood pressure, obesity, and
diabetes and their influence on CVD.
The Diabetes Genes, Treatment, and Prevention in Minorities
Research program, supported by the National Institute on Diabetes,
Digestive, and Kidney diseases and the NCMHD, focuses on the following
groups: Hispanic diabetic adults residing in a rural Texas-Mexico
border community; centrally obese African-Americans with impaired
glucose tolerance; obese Hispanic high school students in Colorado;
African American children, adolescents, and adults with diabetes; and
Caribbean Latinos with non-insulin dependent diabetes. Its objectives
include the development of treatment and prevention interventions that
specifically address diabetes in a range of minority populations and
elucidation of the genetic basis of diabetes in minority populations
and the underlying mechanisms controlled by gene expression.
The National Institute for Nursing Research (NINR) and the NCMHD
will pilot planning activities for a new partnership initiative in
NINR's extramural research program. The focus will be on decreasing
disparities in the burden of illness and mortality experienced by
racial and ethnic populations and the medically underserved through a
variety of approaches, which include basic, epidemiological, clinical
and prevention, control and population research. Cultural and ethnic
considerations, genetic diversity, and social and economic influences
on health and health outcomes are potential areas of emphasis. The
activity will include partnership research, training, and other
activities between Minority Serving Institutions and research-intensive
majority institutions in institutions that provide services to the
rural and urban poor.
Other potential areas where the NCMHD will leverage its funds with
the NIH ICs include: the intersection of non-genetic factors and genes
in health disparities, infectious origins of chronic diseases and
research training.
AN INDEPENDENT RESEARCH GRANT PORTFOLIO
Independent grant-making authority not only increases the Center's
flexibility in leveraging its funds with the NIH ICs, but it also
enables the Center to: focus on ``gap areas'' where such research is
not conducted or supported by the NIH ICs; more effectively build
research capacity in minority health and health disparities research,
address barriers to the participation of minority serving institutions
in the research enterprise, and to develop research capacity among
community-based organizations.
With respect to research, the NCMHD recognizes several pressing
priorities. Our new Division of Research will develop programs to fund
interdisciplinary teams of biomedical, clinical, and social science
investigators--teams that are crucial to developing strategies and
tools for eliminating health disparities. Another priority of the
Division of Research is to ensure that the power of bioinformatics and
genomics research, including pharmacogenomics, is brought to bear on
the health disparity program.
Our new Division of Community-Based Research and Outreach will
identify and implement through research, effective and generalizable
models of health care delivery, disease prevention and intervention,
and communication that will improve community health outcomes in racial
and ethnic minority and other health disparities populations. The
Division will utilize available data generated by other Federal and
State agencies to identify affected communities and to measure progress
in outcomes associated with specific interventions. Key areas of focus
will be to promote research on investigation of health behaviors,
cultural health beliefs and environmental factors in community health.
Validated findings will be utilized and incorporated by the Division to
develop culturally sensitive and appropriate community-based prevention
messages.
CENTERS OF EXCELLENCE PROGRAM
As mandated in its statutory authorities, the NCMHD also will
develop and implement a Centers of Excellence Program to support
minority health research and other health disparities research and
research training for members of health disparity populations. The
exploratory grant mechanism will be used to plan for and promote
interdisciplinary biomedical and behavioral research and to plan for
the establishment of stable research and training programs. Center
planning strategies may focus on a specific research theme (e.g.,
diagnosis, therapy, epidemiology) or integrate a broad spectrum of
research to include the basic, clinical, prevention, and population
sciences. Partnerships between minority institutions and majority
institutions will be encouraged.
RESEARCH ENDOWMENT PROGRAM
The Center also will develop and implement a Centers of Excellence
Endowments Program for certain designated centers and those centers at
Institutions of Emerging Excellence. Potentially a pilot initiative
could begin in 2001. The purpose of the program is to provide enduring,
forward-looking, sustainable support for the Center's minority health
and health disparities research programs and to provide continuing
research infrastructure support.
LOAN REPAYMENT PROGRAM
In fiscal year 2001, the NCMHD will develop and implement two
distinct extramural loan repayment programs recently authorized by the
Congress: the Clinical Research Loan Repayment Program (LRP) and the
Health Disparities Loan Repayment Program (HD-LRP). The emphasis of the
LRP on ``clinical research'' and on individuals from ``disadvantaged''
backgrounds is consistent with the objective of building a culturally
competent cadre of clinical investigators. Such a cadre of clinical
investigators not only will have the potential of having an influence
on the medical processes within their communities but can also engage
in and promote the development of clinical research programs that
reflect an understanding of the variety of issues and problems
associated with disparities in health status. The focus of the health
disparities LRP is specifically on clinical research related to
diseases and conditions having an increased prevalence among racial and
ethnic minorities and other designated health disparity groups.
OTHER CAPACITY BUILDING PROGRAMS
To expand the number of investigators participating in minority
health and health disparities research the NCMHD will promote, assist,
and support research capacity building activities in the minority and
medically underserved communities. These activities will focus on
research infrastructure development, faculty career development, and
increasing the number of under-represented minority students and
students from health disparity groups with an interest in careers in
biomedical and behavioral research.
HEALTH INFORMATION DISSEMINATION
Our health information dissemination activities will be
multifaceted since professionals and the lay-public obtain information
from very dissimilar sources. Information will be transmitted to
professional medical and scientific organizations for dissemination
among their membership, and also will be made available to the public
through media that are most likely to reach racial and ethnic minority
groups.
CONCLUSION
Recognizing that the process of medical discovery occurs in stages,
the Congress has provided many new opportunities to build upon the
previous efforts of the Office of Research on Minority Health. Our
commitment to the research needed to ultimately eliminate health
disparities will be steadfast and enduring, and we will be ever
vigilant in our efforts. We are excited about these opportunities and
greatly encouraged by the strong support the Center has received from
the Congress, the Administration, our fellow NIH IC Directors and from
groups and individuals across the Nation.
______
Prepared Statement of Stephen E. Straus, M.D., Director, National
Center for Complementary and Alternative Medicine
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Center for
Complementary and Alternative Medicine for fiscal year 2002, a sum of
$100,063,000, which reflects an increase of $10,925,000 over the
comparable fiscal year 2001 appropriation.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The past year, NCCAM's second, has been exciting and productive.
With your generous support we continued to build a new research
enterprise dedicated to defining the effectiveness and safety of
diverse complementary and alternative medical (CAM) practices. Many
Americans turn to these practices to relieve or prevent disease
symptoms or the side effects of their treatment, despite a lack of
clear and compelling data about them. We have the scientific tools, the
commitment, and the resources to begin to guide their decisions
regarding these practices. Consistent with our mandate, we have
identified priority areas that warrant more immediate action due to
pressing public health needs and either a dearth of valid scientific
information or sufficient maturation of the science. Allow me to
provide some examples of our approach.
MECHANISMS OF CAM INTERVENTIONS
Among NCCAM's highest priorities is the conduct of Phase III
clinical trials of CAM modalities. NCCAM's Phase III clinical trials
are built upon a substantial body of scientific evidence concerning a
given modality. While complex enough in design and ambitious enough in
scope to address critical scientific issues and patient safety
concerns, these pivotal trials are also well poised to address the
central question: ``Does this therapy work?'' In collaboration with
other NIH Institutes and Centers (ICs), NCCAM supports the following
multiyear, multicenter phase III clinical trials: St. John's wort for
depression, with the National Institute of Mental Health (NIMH); shark
cartilage for lung cancer, the National Cancer Institute (NCI); Gingko
biloba for dementia, the National Institute on Aging (NIA), the
National Heart, Lung and Blood Institute (NHLBI), and the National
Institute of Neurological Disorders and Stroke (NINDS); acupuncture for
osteoarthritis pain, the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS); and glucosamine/chondroitin
sulfate for osteoarthritis, NIAMS.
NCCAM also funds 15 specialty research centers, completing the
research infrastructure platform on which to investigate the mechanisms
underlying CAM treatments and their health effects. NCCAM-funded
centers cover CAM approaches for many areas of major public health
need, including drug addictions, aging and women's health, arthritis,
craniofacial disorders, cardiovascular diseases, neurological
disorders, pediatrics, and chiropractic research. These centers
constitute a major investment of NCCAM's resources and serve as the
focal point for initiating and maintaining state-of-the art
multidisciplinary CAM research. They develop core research resources,
train new CAM investigators, provide community outreach and education,
and expand the research base through collaborative research and
outreach to scientists and clinicians.
While CAM remedies have been employed for centuries, we still
understand little about them. By studying their underlying mechanisms,
we could better monitor their actions and develop biomarkers whose
changes would correlate with beneficial clinical outcomes. Thus, we
would be better positioned to reveal which CAM modalities work and
which do not, and inform the public accordingly.
One prospect is acupuncture, which, after millennia of empiric
development and widespread use in Asia, has emerged as an exciting but
still poorly understood tool for pain management. The ancients imagined
pain as a result of imbalances in energy flow through defined body
channels, or meridians. By inserting needles at precise points,
practitioners attempted to correct the pain-provoking energies. In
contemporary neurobiological terms we understand chronic pain as a
result of abnormal actions within key nerve-signaling pathways from the
periphery to the central brain. NCCAM grantees are testing the value of
acupuncture for pain relief and learning more about its mechanisms of
action. Studies using remarkably sensitive imaging techniques have
pinpointed pain processing centers in the brain and showed that the
activity of these centers is altered when needles are inserted at the
body sites defined by the ancient Chinese practitioners as affording
pain control. Acupuncture-mediated analgesia is not imagined, it is
real. Our clinical trials are exploring the range of conditions for
which acupuncture may provide effective pain relief. Our largest such
study of acupuncture involves the pain of osteoarthritis.
In the largest and most rigorous trial of acupuncture to date,
cosponsored by the National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), the short- and long-term safety and efficacy
of acupuncture for the pain of osteoarthritis of the knee are being
evaluated. In this six-week study, 570 aging Americans are being
randomly assigned to: (1) true acupuncture; (2) sham acupuncture; or
(3) standard education and attention. The goal is to determine whether
patients receiving true acupuncture experience significantly less pain
and fewer limitation than patients in the other groups. A separate
follow-up of the patients in this study will evaluate the long-term
outcomes and cost-effectiveness of the acupuncture intervention.
Another key area of interest is the use of CAM to treat coronary
artery disease (CAD), which is the leading cause of mortality for both
men and women in the U.S. Despite increasingly effective conventional
treatments for CAD, many turn to alternative approaches including the
use of ethylenediaminetetraacetate (EDTA) chelation therapy, a popular
but controversial approach. To date, however, studies of chelation
therapy for CAD have been few, very small in size, and poorly designed,
affording few conclusions concerning its true safety and effectiveness.
To address this important public health issue, NCCAM plans, in
collaboration with the National Heart, Lung and Blood Institute
(NHLBI), to fund the first major, multi-site, clinical trial to
investigate the efficacy and safety of EDTA chelation therapy in
individuals suffering from CAD, using rigorous trial design and
validated outcomes measures: a solicitation (RFA) has been released.
CANCER
NCCAM is applying this same energy and commitment to studies of
cancer. Our rapidly growing research portfolio encompasses both the
study of CAM cancer interventions and palliative care. In fiscal year
2000 NCCAM funded two new Specialty Research Centers dedicated to
studying the safety and effectiveness of several popular CAM cancer
therapies. One center is evaluating the mechanisms of action, safety,
and clinical efficacy of hyperbaric oxygen (oxygen at greater-than-
atmospheric pressures) treatment for head and neck cancers. The other
center conducts studies of breast cancer as well as the first
randomized, placebo-controlled clinical trial of a popular mixture of
eight Chinese herbs, known as PC-SPES, in men with hormone-refractory
prostate cancer. This latter study will evaluate PC-SPES for disease
progression, bone pain, and quality-of-life issues, such as changes in
sexual function, that so often accompany prostate cancers and their
treatment. (The name PC-SPES means hope for prostate cancer.)
Some menopausal and postmenopausal women find symptom relief
through conventional estrogen replacement therapy (ERT). Research has
also shown that ERT benefits cardiovascular, skeletal, genitourinary,
and cognitive health. Despite these benefits, less than 20 percent of
American women use ERT, in part because it seems to be associated with
an increased risk of breast cancer. This dissuades some women from
using it and excludes its use for breast cancer survivors. Many women
explore alternative approaches to estrogen replacement to eliminate the
risks of conventional ERT, with the hope of reaping its benefits while
avoiding its potential hazards. Soybeans are rich in naturally
occurring compounds with estrogen-like activity. Several preliminary
studies of popular soy-derived phytoestrogens (PEs) yielded unclear and
contradictory results, leaving open the question of whether soy may
protect against breast cancer or, like conventional ERT, promote its
emergence. NCCAM intends to conduct Phase II clinical trials to assess
the impact of PE supplementation on women's health after a breast
cancer diagnosis.
Cancer patients for whom a cure is not an option face not only the
prospect of death, but also the diminution of quality of life and
dignity, and intractable pain. Perhaps as many as 70 percent of these
cancer patients seek complementary and alternative therapies to expand
options for end-of-life care. NCCAM is soliciting Phase I and II
clinical trials of CAM modalities for: the prevention and management of
symptoms associated with the end of life, including secondary side
effects of chemotherapy and radiotherapy; and the enhancement of the
patient's well-being.
BOTANICALS
Botanicals, among the most popular CAM therapeutics, are relied
upon for treatment and prevention of a number of conditions. In
collaboration with the NIH Office of Dietary Supplements (ODS), NCCAM
funds four Centers for Dietary Supplement Research with an emphasis on
botanicals. The Centers identify and characterize botanicals, assess
their bioavailability and activity, explore mechanisms of action,
conduct preclinical and clinical evaluations, establish training and
career development, and help select the products to be tested in
randomized controlled clinical trials. Our plans include studying
botanical-drug interactions, the developing standardized botanical
products, and examining the safety and effectiveness of cranberry
products in preventing urinary tract infections.
HEALTH DISPARITIES
In conjunction with the trans-NIH effort to address U.S. health
disparities, we have recruited a director for the NCCAM Office of
Special Populations and charged him to expand our own research plan in
this area. We plan to: identify the extent and nature of CAM use among
special populations; studying the application of CAM therapies to
reduce disparities; increase participation of underrepresented
populations in NCCAM-supported clinical trials; and enhance the ability
of minority institutions to support CAM research. This plan will serve
through fiscal year 2005 as a guide for developing new initiatives to
address minority health and health disparities. In the near term, NCCAM
intends to determine the prevalence of CAM use by different minority
and underserved populations, initiate studies on the use of magnesium
sulfate in the treatment of acute asthma, and use the National Research
Training Award (T32) mechanism to support pre- and post-doctoral
trainees in CAM research at minority and minority-serving institutions.
INTEGRATIVE MEDICINE AND RESEARCH TRAINING
NCCAM has initiated a series of specific activities to facilitate
the successful integration of safe and effective CAM modalities into
mainstream medical practice. We conduct research that provides
compelling evidence of efficacy and safety and publishing these
findings in peer-reviewed journals, study factors that promote or
impede integration, support the development of model curricula for
medical and allied health schools and continuing medical education
programs, and inform the public in a clear and definitive manner. In
fiscal year 2001, we launched a new integration initiative to study
factors that promote or impede integration, determine whether CAM
research results can be translated to real-world settings, and support
the evaluation of programs that integrate CAM and conventional care.
Integrative medicine is also a key component of NCCAM's Intramural
Research Program and a component of NCCAM's Specialized Research
Centers.
NCCAM's ability to achieve its research goals depends on the
availability of a critical mass of skilled investigators in both CAM
and conventional communities. It is our goal to increase the knowledge,
experience, and capacity of CAM practitioners to conduct or participate
in rigorous research. We also intend to enhance conventional
practitioners' and researchers' knowledge and experience in specific
CAM areas. We actively support research training by making awards to
both institutions and individuals. Likewise, NCCAM supports mentored
and independent trainees, from the pre-doctoral level through mid-
career and senior faculty members. The research spectrum of these
trainees is broad, covering the continuum of basic through clinical
studies. NCCAM supports all of the major training mechanisms offered by
NIH.
CONCLUSION
As the graying of America progresses, more of our citizens are
choosing CAM approaches when conventional medicine fails to provide
complete satisfaction. It is, therefore, imperative that we continue to
expand our research portfolio, train researchers, and fund research
studies to scientifically establish critical safety and efficacy
information for dissemination to healthcare providers and consumers. I
am confident that the results of our rigorous research will further
enhance the successful integration of safe and effective CAM modalities
into mainstream medical practice.
I am now happy to take your questions about these or any other of
NCCAM's activities and plans.
______
Prepared Statement of Allen M. Spiegel
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK) for fiscal year 2002, a sum
of $1,457,915,000, which reflects an increase of $154,098,000 over the
comparable fiscal year 2001 appropriation. 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 second annual performance report which
compares our fiscal year 2000 results to the goals in our fiscal year
2000 performance plan. As performance trends on research outcomes
emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The NIDDK supports research on a wide range of chronic,
debilitating diseases including diabetes; hepatitis and other liver
diseases; inflammatory bowel disease; interstitial cystitis and other
bladder conditions; prostatitis and benign prostate enlargement;
several anemias; and polycystic kidney disease and other causes of end-
stage kidney failure. The economic burden of these diseases accounts
for a major portion of U.S. health care expenditures. Advances in
biomedical research are critical if we are to mitigate the human and
economic burden of these diseases. With the generous support Congress
has provided, NIDDK-supported scientists are well positioned to
identify the causes of the diseases within our mission, to help
identify people at risk for development of these diseases, and,
ultimately, to provide novel approaches to prevention and treatment.
DIABETES
One of the most important health care issues facing our Nation is
the increasing burden of diabetes. According to the Centers for Disease
Control and Prevention (CDC), diabetes affects an estimated 16 million
Americans, one-third of whom are unaware they have the disease and are
therefore untreated. An estimated 30 million additional Americans have
a pre-diabetic condition known as impaired glucose tolerance. Within
the last year, scientists have made tremendous progress in
understanding and treating both type 1 and type 2 diabetes. Type 1, or
juvenile diabetes, occurs when the body's immune system destroys the
insulin-producing beta cells in the islets of the pancreas. Type 2
diabetes, previously called non-insulin dependent or adult-onset
diabetes, results from the body's inability to respond to insulin
effectively--a condition known as insulin resistance--followed by a
failure of the beta cells to produce sufficient insulin.
People with type 1 diabetes must take regular insulin injections to
survive. However, insulin represents only a treatment for type 1
diabetes, not a cure. Recent advances have created new hope for a cure
for type 1 diabetes through pancreatic islet transplantation. The NIDDK
is supporting several clinical trials to expand upon a promising study
in which islet transplantation permitted a small number of people with
type 1 diabetes to remain healthy for over a year without daily insulin
injections. We are also supporting research on many aspects of beta
cell development and function so that we can address the problem of the
inadequate supplies of donor pancreatic tissue for transplantation,
possibly by developing alternative sources of islet beta cells. In
addition, we are supporting research on alternatives to lifelong
immunosuppressive drug treatment currently required to prevent
rejection of transplanted islets. One innovative approach uses a short
course of therapy to teach the immune system to accept a transplant as
``self,'' avoiding tissue rejection without global immunosuppression.
Not only do these novel approaches to educating the immune system
increase the likelihood of achieving a true cure for type 1 diabetes,
they also offer hope of preventing the disease in those at risk. Trials
of innovative prevention measures will be performed as part of our
newly-created type 1 diabetes TrialNet.
Type 2 diabetes is a ``complex genetic disease'' with subtle
changes in the function of several genes contributing to disease
susceptibility. Despite the technical difficulties in identifying such
gene changes, researchers studying a population of Mexican Americans
who are particularly prone to type 2 diabetes identified changes in a
gene--NIDDM1--that correlate with development of the disease. The
product of this gene--calpain 10--is present in pancreatic islets,
muscle, and liver--all tissues that are involved in insulin and glucose
processing. Scientists have identified at least three other chromosomal
regions whose products may interact with NIDDM1 to increase
susceptibility to type 2 diabetes. Knowledge of the genetic basis for
diabetes susceptibility paves the way to improved prevention and
diagnosis by identifying individuals at risk, and to improved treatment
by providing new targets for therapy.
Obesity is a major risk factor for type 2 diabetes. The alarming
increase in the number of people who are overweight or obese in the
U.S. population has led to a coincident increase in type 2 diabetes in
adults, and even in children and adolescents. Successful control of
body weight could therefore profoundly diminish the incidence of type 2
diabetes. In just the past few years, there have been major advances in
our understanding of how weight is regulated. Scientists have
identified many of the steps in a complex pathway that controls both
appetite and metabolic rate. An imbalance in this regulation can lead
to the accumulation of excessive body fat. Until recently, the precise
mechanism by which excess fat led to insulin resistance and type 2
diabetes was unclear. However, several recent advances have changed the
way scientists view fat, and have underscored that fat--far from being
an idle repository of excess energy--is in fact a dynamic tissue that
produces a number of hormones with the potential to influence appetite
and metabolism.
Leptin, a protein produced by fat cells that acts on the brain to
suppress appetite, was discovered just six years ago, but has already
entered clinical trials in humans. More recently, by ``mining'' mouse
and human genome sequences, scientists have identified other hormones
produced by fat cells that act on muscle and liver--the primary sites
in the body of glucose metabolism and insulin action. For example,
NIDDK grantees identified a protein produced by fat cells they termed
``resistin,'' because it promotes insulin resistance. Obesity causes
increased levels of resistin in blood, thus providing a direct link
between excess body weight and the diminished insulin sensitivity often
seen in overweight individuals. Another group of NIDDK-supported
investigators identified another protein produced by fat cells--called
Acrp30--that acts to increase fat metabolism in muscle, thereby
promoting weight loss. Together, these studies indicate that fat cells
produce hormones that may either promote or inhibit insulin
responsiveness. Under normal circumstances, these two opposing signals
keep each other in check. However, in obese individuals, this balance
may be perturbed, and drugs that block or mimic these hormones may
prove useful in both prevention and treatment of obesity and type 2
diabetes.
In addition to genetic susceptibility, the environment exerts an
influence on the development of obesity and type 2 diabetes. The NIDDK
is therefore supporting initiatives on environmental approaches to
obesity prevention, including educational efforts. We are launching a
major initiative aimed at prevention and treatment of type 2 diabetes
in children and adolescents. A major multi-center clinical trial, the
Diabetes Prevention Program (DPP), is testing the ability of lifestyle
and drug intervention strategies to prevent type 2 diabetes in
individuals with impaired glucose tolerance who are at high risk for
the disease. The results of this trial, slated for completion in 2002,
may have major public health implications for the prevention of type 2
diabetes.
Diabetes is the leading cause of end-stage kidney failure, new
cases of blindness in adults, and non-traumatic lower limb amputations.
It also causes increased susceptibility to urinary tract infections and
a progressive form of fatty liver disease known as non-alcoholic
steatohepatitis (NASH). Heart disease is the leading cause of death in
diabetics, and the NIDDK is sponsoring a clinical trial--Look AHEAD--
that will determine whether sustained weight loss in obese people with
type 2 diabetes can reduce the incidence of cardiovascular
complications. According to the American Diabetes Association, diabetes
cost the country $98 billion in 1997, and over half of this expense was
related to the disability, lost productivity, and early mortality
associated with the disease. We know that prevention of diabetes, and
where prevention is not possible, optimal management of the disease,
not only alleviates human suffering but is cost-effective. For this
reason, the NIDDK is exploring many avenues of prevention and treatment
for diabetes and its complications, including basic genetic and
molecular studies, development of animal models to facilitate testing
of new drugs, therapeutic gene transfer techniques, and drug
intervention trials. We are also increasing the resources available to
our Diabetes Research and Training Centers to enhance efforts in
diabetes prevention and treatment, and are expanding the National
Diabetes Education Program (NDEP), which supports community-based
multi-cultural efforts to increase diabetes awareness, to improve care
of people with diabetes.
HEPATITIS C AND OTHER CHRONIC LIVER DISEASES
The NIDDK supports research on many other serious diseases,
including liver disease arising from a range of causes. In the U.S.,
infection with the hepatitis C virus is a leading cause of liver
failure and can lead to liver cancer. The newly-initiated HALT-C trial
is testing whether long-term antiviral treatment can eliminate the
hepatitis C virus in patients who fail to respond to conventional
treatment. We are also initiating a trial of interferon treatment for
hepatitis C in African Americans, whose disease is often resistant to
the standard treatment regimen.
The NIDDK is also studying NASH, a disease characterized by fat
deposition in the liver that can lead to inflammation, fibrosis, and
cirrhosis. NASH is most often seen in overweight individuals and is
associated with diabetes and insulin resistance. NIDDK plans a clinical
research network to study the natural history, complications, and
possible therapies for NASH. Whatever the precipitating cause, liver
failure is ultimately only treatable currently through liver
transplantation. Unfortunately, the need for donor livers far outstrips
the supply of available organs. The NIDDK organized a workshop in
December 2000 to assess recent advances in adult-to-adult living donor
liver transplantation. An important outcome of this meeting is the
development of a research initiative for a prospective database to
further knowledge about the consequences of living donor liver
transplantation, both for the donor and the recipient.
INFLAMMATORY BOWEL DISEASE AND OTHER DIGESTIVE DISEASES
The NIDDK sponsors studies on the inflammatory bowel diseases
(IBDs), ulcerative colitis and Crohn's disease, including efforts to
identify their genetic and environmental causes. A contributing factor
to both conditions is believed to be an inappropriate reaction by the
body's immune system to the bacterial flora normally present in the
gut. Previous research on mouse models of IBD led to the discovery of a
factor responsible for gut inflammation, and ultimately to development
of an antibody to neutralize this factor that has been shown to be
effective in treatment of Crohn's disease. In recent studies, NIDDK-
supported investigators have identified a strain of mice that
spontaneously develop intestinal inflammation remarkably similar to
Crohn's disease. They have shown that these mice can be efficiently
used to test new treatments for the disease. In the future, the NIDDK
plans an IBD Genetics Consortium to facilitate identification of
susceptibility genes, and a clinical network to accelerate studies of
prevention and treatment of IBD.
END-STAGE RENAL DISEASE AND POLYCYSTIC KIDNEY DISEASE
According to the United States Renal Data System, individuals with
diabetes account for approximately 45 percent of patients with end-
stage kidney disease. Because of this, the NIDDK is concentrating its
efforts on preventing diabetic kidney disease and slowing its
progression. The Institute is expanding the FIND (Family Investigation
of Nephropathy and Diabetes) consortium to identify genetic loci and,
ultimately, the specific genes that influence susceptibility to, and
severity of, diabetic nephropathy. The Institute is also investigating
the causes and possible new treatments for FSGS (Focal Segmental
Glomerular Sclerosis), an important cause of kidney failure in children
and young adults. The Institute plans a multi-center clinical trial to
study treatment approaches for FSGS.
NIDDK support is also making a difference in understanding other
important causes of irreversible kidney failure such as polycystic
kidney disease (PKD). NIDDK-funded researchers are studying non-
invasive means of assessing PKD progression, which will facilitate a
planned clinical trial of drug intervention to slow progression. A new
prospective observational study is aimed at understanding the factors
responsible for the high incidence of heart disease in patients with
end-stage kidney disease. Because folate lowers levels of homocysteine,
a known risk factor for heart disease, we are also planning a clinical
trial on the use of high doses of this vitamin in the prevention of
heart disease in renal transplant recipients. We are also launching a
National Kidney Disease Education Program to address the rising
incidence of end-stage kidney disease, particularly in various minority
groups.
UROLOGIC DISEASES
The NIDDK is sponsoring initiatives to promote understanding of a
range of urologic diseases, including interstitial cystitis, benign
prostatic hyperplasia (BPH), and chronic prostatitis. The Institute is
working to organize a compendium of ``Urologic Diseases in America''
that will describe the changes in the epidemiology, health economic
impact, and practice patterns for each of the diseases currently
included within the scope of urology. The Institute has recently
organized a Progress Review Group for Bladder Research to develop a
future research agenda. We are also building on our Medical Therapy of
Prostatic Symptoms (MTOPS) Trial with a national registry of prostate
tissue samples that will allow urology investigators to harness genomic
technology to study BPH and prostate cancer.
The NIDDK continues to pursue many approaches to combat the serious
diseases within its mission in order to relieve the burden they place
on individuals, families, and the Nation. I appreciate the opportunity
to address the Committee, and I thank you for your attention. I look
forward to answering any questions you might have.
______
Prepared Statement of Lawrence A. Tabak, Director, National Institute
of Dental and Craniofacial Research
I am pleased to present the President's budget request for the
National Institute of Dental and Craniofacial Research (NIDCR) for
fiscal year 2002, a sum of $341,898,000, which reflects an increase of
$35,687,000 over the comparable fiscal year 2001 appropriation.
The first-ever Surgeon General's report on oral health was released
last year, and the good news was that Americans as a whole have
benefitted greatly from advances in disease prevention and health
promotion in recent decades. Improvements in oral health because of
research have saved the nation an estimated $5 billion a year in dental
bills-an annual savings amounting to more than the cumulative funding
for NIDCR since its inception in 1948.\1\ Our work is not finished,
however. Millions of Americans still experience pain and suffering from
complex diseases affecting the mouth and face, including oral cancer,
cleft lip and palate, dental caries (tooth decay), periodontal (gum)
diseases, and temporomandibular disorders. More research is needed to
understand the associations between oral infections and conditions such
as diabetes and low birth weight. We also need new studies to help us
understand and eliminate oral health disparities in this country. By
funding cutting edge biomedical and behavioral research, NIDCR strives
to fulfill our mission of improving oral health for all Americans.
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\1\ Brown, L.J., T. Beazoglou and D. Heffley. ``Estimated Savings
in U.S. Dental Expenditures, 1979-1989''. Public Health Reports, 1994,
109, 195-203.
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reducing oral health disparities to improve quality of life for all
americans
Scientific advances have led to substantial gains in the nation's
oral health, but not all Americans have shared equally in these gains.
Disparities in oral health exist at all ages and in many different
population groups within our society. For example:
--Cancers of the mouth and throat, which kill about 8,000 Americans a
year, take a disproportionate toll on African Americans,
particularly men. African American men are one-third more
likely than whites to be diagnosed with oral cancer, and their
5-year survival rate is only 28 percent, compared to a 53
percent survival rate for white men.\2\
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\2\ Miller, B.A. et al, editors. Racial/Ethnic Patterns of Cancer
in the United States, 1988-1992. National Cancer Institute, National
Institutes of Health. NIH pub. No. 96-4104. Bethesda (MD): National
Institutes of Health, 1996.
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--Dental caries, or tooth decay, is the most common chronic disease
of childhood--five times more common than asthma and seven
times more common than hay fever. Children from low-income
families suffer twice as much dental decay as their better-off
peers, and their disease is more likely to go untreated.\3\
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\3\ National Center for Health Statistics 9NCHS). Third National
Health and Nutrition Examination Survey (NHANES III) reference manuals
and reports. Hyattsville, MD: NCHS, U.S. Department of Health and Human
Services, Public Health Service, Centers for Disease Control and
Prevention, 1996.
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--African American adolescents are 10 times more likely than white
teens to suffer from early-onset periodontitis, a severe and
rapidly progressive form of gum disease that destroys the bone
supporting the teeth.\4\
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\4\ Albandar JM, Brown LJ, Loe H. Clinical features of early-onset
periodontitis. Journal of the American Dental Association 1997
Oct;128(10): 1303-9.
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The causes of these and other oral health disparities are not fully
understood, but genetic, environmental, and behavioral factors all
likely play a role. This year, NIDCR will establish Centers for
Research To Reduce Oral Health Disparities. The centers will conduct a
broad range of interdisciplinary research aimed at reducing health
disparities. Much of this work will be focused on, and conducted in,
the communities where the disproportionate disease burden is evident.
The centers will provide ideal environments for training new
scientists, particularly those from minority groups underrepresented in
the scientific workforce. Because cross cutting research is essential
for reducing health disparities, we are using mechanisms designed to
encourage training in multidisciplinary research. Recognizing the need
to establish the effectiveness of interventions for different
population groups, we are also taking steps to ensure that all
population groups are appropriately represented in clinical trials.
These steps include providing investigators with the tools to
facilitate community-based linkages for research. One advance with
potential for application in community settings is the use of saliva-
based diagnostic tests. Saliva, which is easier and less invasive to
collect than blood, is already being used in a number of tests, and may
provide a means of detecting diseases such as oral cancer at an
earlier, more curable stage.
chronic infectious diseases: dental caries and periodontal diseases
The most common oral diseases, and among the most prevalent of all
chronic infectious diseases, are dental caries (tooth decay) and
periodontal (gum) diseases. These diseases affect people throughout the
life span, requiring lifelong attention by both the individual and
health care providers. The Health Care Financing Administration
estimates that dental expenditures by 2000 approached $60 billion, most
of which was spent repairing teeth and periodontal tissues.
Dental caries and periodontal diseases are infections caused by
bacteria that accumulate in the form of a ``biofilm'' on the surfaces
of teeth and soft tissues. NIH and NIDCR recently sponsored a Consensus
Development Conference on the diagnosis and management of dental caries
that pointed to the need for earlier detection of dental decay to allow
for more conservative intervention.
Long considered localized infections, periodontal diseases are now
linked to a number of systemic diseases and conditions. For example,
periodontal disease in pregnant women may contribute to the risk of
delivering pre-term, low birth weight babies. The destructive
inflammatory processes that define periodontal disease are also
intertwined with diabetes. Periodontal diseases are exacerbated in
individuals with uncontrolled diabetes, and researchers are examining
the effects of periodontal infections on blood sugar control. These and
other interrelationships were highlighted at a recent symposium co-
sponsored by the NIDCR entitled ``The Periodontal-Systemic Diseases
Connection.''
RESEARCH CREATES NEW MATERIALS FOR REPLACING AND RESTORING DAMAGED
TISSUES
As people continue to live longer, the demand increases for ``new
parts'' to repair or replace those lost to disease, injury, and wear-
and-tear. Each year, millions of Americans suffer some type of tissue
loss or end-stage organ failure, at a cost of more than $400 billion
annually.\5\ Included in these figures are millions of dental, oral,
and craniofacial procedures, ranging from tooth restorations to major
reconstruction of facial tissues.
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\5\ Langer, R. and Vacanti, J.P. ``Tissue Engineering'', Science,
May 14, 1993, 260. 92.
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Biomimetics (literally, to mimic biology) and tissue engineering
are new disciplines that have emerged to meet the challenge of
rebuilding the body. In the same way that Velcro inventor George de
Mestral imitated the natural adhesion of burrs, biomimetics researchers
take cues from nature to design ``bio-inspired'' materials. For
example, NIDCR-supported scientists have created a biomimetic material
that promotes bonding of bone-forming cells to artificial surfaces, an
achievement with tremendous potential for improving dental and
orthopedic implants. Poor bonding to surrounding bone is one of the
biggest reasons for dental implant failure. The researchers synthesized
a material that mimics a natural binding site for bone-forming cells;
when an artificial surface is coated with the material, bone-forming
cells respond by building new bone around the surface, creating a
strong bond.
Using the new technology of tissue engineering, NIDCR researchers
are developing an artificial salivary gland that could restore salivary
flow to patients whose own glands are destroyed by disease or radiation
therapy for head and neck cancers. Currently no effective treatments
exist for these patients, whose quality of life is severely compromised
by difficulties in chewing, swallowing, and speaking and by an
increased risk of rampant tooth decay and other oral infections. The
NIDCR scientists are creating a small tube that could be implanted in a
patient's cheek. The tube will be lined with cells engineered to
secrete a saliva-like fluid. The artificial salivary gland could be
ready for clinical testing within 5 to 7 years.
GENETIC RESEARCH IS KEY TO UNDERSTANDING CRANIOFACIAL DISORDERS
Genetic research by NIDCR scientists is revealing the basis for a
number of craniofacial birth defects, offering hope to thousands of
Americans who suffer pain, dysfunction, and emotional consequences from
malformations of the mouth and face. Cleft lip, with or without cleft
palate, is among the most common of human birth defects, affecting 1 in
1,000-2,500 newborns. Most cleft disorders-in which the lip or palate
fail to fuse properly-occur alone, although they may also be part of
birth defect syndromes that affect many organs and tissues. Many cleft
disorders are caused by single gene mutations. NIDCR-supported
scientists recently identified a gene called PVRL1 as the cause of one
form of cleft lip/palate. The gene codes for a cell surface adhesion
protein called nectin-1. In mice, this protein aids in the development
of the palate, teeth, and skin--the same tissues that are malformed in
humans with a mutation in PVRL1. Other NIDCR-funded researchers have
found that a mutation in a gene called PAX9 results in missing molar
teeth. Their work may lead to a better understanding of congenital
disorders in which teeth fail to develop. Approximately 20 percent of
the population is born unable to develop a full set of permanent teeth.
INVESTIGATING THE ORAL CAVITY'S CONTRIBUTION TO DEFENDING THE BODY
AGAINST HIV INFECTION
The specific factors that result in relatively high rates of HIV-1
transmission by breast milk but minimal rates of transmission by saliva
are not known. Therefore, studies of oral defense systems may prove
instructive for development of new preventive strategies for HIV
infection. One intriguing finding is that saliva consistently exhibits
anti-retroviral activity, whereas breast milk only displays this
property when collected during the first three weeks after childbirth.
The potentially important anti-retroviral activity appears to be lost
three weeks postpartum. While many factors likely contribute to the
anti-retroviral activities observed in saliva and breast milk, one
factor, called secretory leukocyte protease inhibitor (SLPI), is found
at high levels in saliva. While SLPI levels are high in breast milk at
birth, this anti-microbial substance virtually disappears from the milk
three weeks after delivery. Despite the risk of HIV-1 transmission from
breast-feeding, the risk of death from malnutrition for nonbreast-fed
children in many parts of the world has resulted in controversial
recommendations about breast-feeding. Studies on the timing of
postnatal transmission of HIV-1 and the innate protective correlates
may provide a better understanding of a ``safer'' window of breast-
feeding and the specific roles of anti-retroviral substances in natural
secretions that could be exploited as future therapies.
NEW METHODS NEEDED TO TREAT CHRONIC PAIN AND TEMPOROMANDIBULAR
DISORDERS
Most people have experienced some form of oral-facial pain. A
variety of painful facial conditions may interfere with vital functions
such as eating or speaking. NIDCR scientists are continuing to develop
novel approaches to selectively block pain receptors in the body. A
recent study in an animal model makes use of gene therapy to deliver a
message to cells that ``tricks'' them into producing reduced levels of
pain receptors on their surfaces. If similar techniques can be designed
to work in humans, this approach may benefit chronic pain patients.
Various factors, including trauma, can give rise to pain and
dysfunction in the temporomandibular joints and surrounding muscles--
conditions collectively called TMD. The multiplicity of factors that
may cause or contribute to TMD has unfortunately led to an even greater
number of treatments that have not been validated. NIDCR is conducting
clinical trials looking at the effects of conservative versus surgical
interventions, with preliminary findings indicating that surgical
interventions offer no increased benefits. To address the needs of
patients who require joint replacement, NIDCR is conducting basic
research on engineering more biocompatible implants. Given the
complexity of TMD and the need to approach this condition in a
multidisciplinary manner, the Institute established the TMD Interagency
Working Group to facilitate progress in dealing with these disorders
through cooperation, communication, and collaboration among the many
Federal agencies that conduct or support TMD-related research and
direct provision of health care services.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
I became Director of NIDCR eight months ago with great enthusiasm
about the opportunities to make a difference in improving the nation's
oral health through biomedical research. As NIDCR Director, one of my
main goals is to accelerate our progress toward relieving the burden of
the many chronic and costly diseases that affect the mouth and face.
Having been an NIDCR grantee for many years, I knew before arriving how
important the Institute is to the scientists who conduct oral, dental,
and craniofacial research and to the well being of the people of this
country. Seeing it work from the inside has given me a new appreciation
for the organization, its talented and dedicated staff, and the role of
the Institute nationally and internationally.
Thank you for the opportunity to provide you with information on
NIDCR's research efforts.
______
Prepared Statement of Dr. Judith L. Vaitukaitis, Director, National
Center for Research Resources
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the National Center for Research
Resources (NCRR) for fiscal year 2002, a sum of $974,038,000, which
reflects an increase of $156,785,000 over the fiscal year 2001
appropriation.
It is a pleasure once again to have the opportunity to present the
accomplishments of NCRR-supported research and future directions for
NCRR programs. With the human genome and several others essentially
sequenced, biomedical research is entering a new age. Up until now,
biomedical science has benefitted greatly from a reductionist
perspective which examines single genes or their encoded macromolecules
to determine the cause of disease. But today, new research technologies
enable scientists to pry ever deeper into the cell to uncover the
structural and functional secrets of the ribosome which serves as the
cell's protein factory and also to find hundreds of disease-associated
proteins. With advanced technologies investigators have discovered
defective membrane potassium channels responsible for some forms of
epilepsy or abnormal heart rhythms that may be fatal if the genetic
abnormalities resulting in altered potassium channel function are not
detected and treated.
Sophisticated biomedical research now frequently requires a
multidisciplinary approach with teams that include physician-
investigators, physicists, bioinformaticists, physical chemists,
structural biologists, and others. The research team must not only take
full advantage of existing novel research tools but must also develop
novel ones to solve new complex research problems.
To facilitate this new paradigm for research, NCRR's programs need
to modify or generate new, more sophisticated resources to enable
research in the 21st century. NCRR provides the critical research
infrastructure that enables all lines of biomedical inquiry, from the
molecular level to the whole organism. Specially adapted clinical
research facilities assure that the fruits of bench research reach the
patient. The network of NCRR's General Clinical Research Centers
(GCRCs) require sophisticated core laboratories and bioinformatics
tools to facilitate research. To foster multisite research
collaborations, NCRR supports development of web-based research
networks for clinical trials and research on the molecular and other
causes of disease.
To enhance access to costly technologies, NCRR works in partnership
with other Federal agencies, such as the Department of Energy and the
National Science Foundation (NSF). For decades, NCRR has funded a
substantial research effort to improve x-ray crystallography
techniques. NCRR has been a pivotal player in developing very high
intensity x-ray sources for biological research at the national
synchrotron facilities, through cooperative approaches with DOE and NSF
staff. The nation's synchrotron facilities are critical for
ascertaining the structures of biological molecules encoded by
thousands of genes. With the incorporation of robotics, newer imaging
technologies along with methods to automate data collection and
processing, an appropriately equipped research resource may conduct
more than one hundred thousand crystallization experiments per day!
Using NCRR research resources, studies in the past required years of
effort, will be accomplished in a week!
NCRR also supports programs to enhance the research capabilities of
minority-serving graduate institutions through the Research Centers in
Minority Institutions (RCMI) program. Separately, through the
Institutional Development Award (IDeA) program, NCRR provides funding
for capacity building for biomedical research in those States which
have not previously participated fully in the research programs of the
NIH. The current cohort of 23 IDeA-eligible States and Puerto Rico
receives about five percent of NIH grant funds annually.
GENOMICS AND GENETIC MEDICINE
To determine the genetic causes of diseases, large numbers of
patients must be screened for specific gene variants. NCRR proposes to
support national genotyping laboratories to provide a cost-effective,
high throughput approach. Genotyping attempts to find nucleotide
substitutions at specific points, or loci, within a gene that may be
defective and cause disease. In addition, NCRR proposes to expand the
capacities of its mouse mutant regional resource centers network to
accommodate a rapidly expanding pool of mouse mutants and to support a
web-based catalog of their genetic variants and physical
characteristics or phenotype. The mutant mouse network's catalog will
facilitate investigator access to mouse mutants needed for their
research.
Scientists today urgently need improved or new technologies to
study the thousands of proteins that interact with one another to make
a cell function as a tightly controlled unit. This complex research
requires an integrated or systems approach. In response, NCRR proposes
to develop and support comprehensive Integrated Biomedical Technology
Resource Centers, where multiple complementary technologies examine the
inner workings of both healthy and diseased cells. Research areas that
can be facilitated through integrative approaches include those for
proteomics, imaging, structural biology and glycobiology.
NCRR proposes to develop the rhesus macaque as an nonhuman primate
model of genetic disease in humans. In collaboration with the National
Human Genome Research Institute, NCRR will provide support for the
development of BAC (Bacterial Artificial Chromosome) libraries as well
as for genetic and radiation hybrid maps. New technologies have made it
theoretically possible to selectively modify genes of nonhuman primates
to create defects that mimic human diseases, such as cystic fibrosis.
Studies will also address how risk factors modulate gene function in
polygenic disorders such as type 2 diabetes mellitus and hypertension.
BIOENGINEERING, BIOIMAGING, AND BIOINFORMATICS
Today's biomedical research depends on sophisticated research
technologies more so than in the past. NCRR proposes to increase
support for instruments in the $100,000 to $500,000 range through its
Shared Instrumentation Grant (SIG) Program. The off-the-shelf
instruments in greatest demand through the SIG program include confocal
microscopes, NMR spectrometers, cell sorters, mass spectrometers and
protein/DNA sequencers. To address the broad research community needs
of the instrumentation that costs between $500,000 and several million
dollars, NCRR proposes to initiate a new program to provide advanced
instrumentation that includes very-high-field NMR spectrometers,
synchrotron facilities, mass spectrometers, cryoelectron microscopes,
and high-performance supercomputers.
To further enhance the national infrastructure for biomedical
research, NCRR will establish a biomedical imaging research network
(BIRN) test bed for development of hardware, software, and protocols to
effectively share and mine data in a site-independent manner for both
basic and clinical research. For this undertaking, NCRR has teamed up
with the San Diego Supercomputer Center, one of three National Science
Foundation-supported centers for advanced computational infrastructure,
to provide biomedical investigators access to sophisticated modeling
and computational tools. Other partners include the NSF, University of
California at San Diego and several NIH Institutes along with seven
institutions with NCRR-supported general clinical research centers, co-
located with imaging technology centers. The BIRN will include image
data with high-bandwidth requirements, as well as genomic, structural,
and gene expression data. The BIRN will be designed so that it can be
readily expanded to meet the evolving needs of basic and clinical
investigators across a network of resource centers that provide access
to specialized research facilities, repositories and regional core
facilities to enable research nationwide.
NEW PREVENTIVE STRATEGIES AGAINST DISEASE
Not all research advances lie in medical genetics. Scientists have
observed recently that transplantation of insulin-producing human
pancreas cells, called islet cells, to patients with type I diabetes
can free them from the need for insulin injections. But to get a
sufficient supply of these scarce and difficult-to-isolate cells, cell-
harvesting efficiency and islet cell stability need to be optimized. To
pursue these very promising results, which eventually may provide a
cure for type I diabetes, NCRR--together with the National Institute of
Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes
Research Foundation International-will establish several Islet Cell
Resource Centers to optimize the isolation, purification, and function
of islet cells for transplantation into patients with type I diabetes.
As clinical research becomes more complex and promising new
therapies are evaluated, more attention to the safety of research
subjects must be taken. The NCRR will provide support for a Research
Subject Ombudsman (RSO) at each General Clinical Research Center (GCRC)
and RCMI Clinical Research Center to ensure that the research subject
monitoring plan at these resources is fully implemented and carried out
according to the Institutional Review Board-approved protocol. The
Ombudsman will also ensure that investigators report serious adverse
events within a required time frame to appropriate agencies, offices or
Boards. Th RSO will also keep patients and volunteers informed about
the research projects and clinical trials in which they participate.
HEALTH DISPARITIES
To address the health concerns of minority populations, NCRR
proposes to establish Comprehensive Centers for Health Disparities
Research at minority-serving medical schools associated with the NCRR-
funded Research Centers in Minorities Institutions. These Centers will
further develop their medical schools' capacities to conduct basic and
clinical research on type II diabetes and cardiovascular disease, which
disproportionately affect minority populations. The Centers will
support further development of the host institution's research
infrastructure, including laboratories, faculty recruitment of
established clinical investigators and development of promising junior
faculty. Collaboration with nearby research-intensive universities will
be strongly encouraged. To further strengthen these minority
institutions, NCRR also proposes to establish a Web-based clinical
trials network for minority-serving institutions. This new network will
better position minority-serving medical schools to more fully
participate in NIH-supported research, including multi-site clinical
trials that address diseases that disproportionately affect minorities
and underserved populations.
RESEARCH TRAINING AND CAREER DEVELOPMENT
Proper training in research methodology is essential for young
scientists. NCRR proposes to initiate new mentored programs for medical
and veterinary students to develop their research skills and pique
their interests in research careers to enhance the pool of well-trained
young physicians and veterinarians who will become the independent
investigators for tomorrow's health-related research.
In addition to expanding support for the Mentored Patient-Oriented
Research Career Development Award (K23), NCRR proposes to initiate a
new career development program for physicians and dentists through a
mentored institutional Clinical Research Scholars (CRS) program. That
CRS pilot program will be phased in over several years at approximately
ten institutions. The flexible program will provide tuition support for
didactic courses, leading to an M.S., Ph.D. or M.P.H. degree. The CRS
program support for candidate development of clinical and bench
patient-oriented research skills in a mentored setting is central to
this new program. The long term CRS program goal is to enhance the pool
of high quality independent clinical investigators.
RESEARCH CAPACITY
Adequate, up-to-date facilities are indispensable for biomedical
research, but according to a 1998 NSF survey, biomedical research
institutions had to defer $5.6 billion for needed construction and
renovation projects. The greater biocomplexity of modern research
requires state-of-the-art research facilities. The NSF survey estimated
that less than half of existing research facilities could conduct
sophisticated biomedical research. Through the NIH Research Facilities
Improvement Program, NCRR will expand its support to help address this
need.
Modern research facilities are also needed to provide care and
housing for chimpanzees that were originally bred for AIDS research. So
far, chimpanzees have not proven to be suitable models for studies of
AIDS pathogenesis, but they are essential for studies of respiratory
syncytial virus, hepatitis, malaria, and possibly for AIDS vaccine and
gene vector development. To consolidate the NIH-supported chimps into
just two or three sites, animal housing must be constructed to provide
cost-effective facilities that will assure the well-being and safety of
the animals and people who work with them. Funding to construct a
chimpanzee sanctuary system is also needed to accommodate chimpanzees
no longer eligible or required for research.
NCRR proposes to increase the level of support for the Animal
Facilities Improvement Program. About half of all NIH research grants
include animal research models and institutions need to build specially
adapted, modern research facilities to accommodate these genetically
altered rodents. A special initiative to upgrade the research animal
facilities of minority graduate and health profession schools will be
continued to help those institutions meet PHS standards and receive
accreditation by the Association for Assessment and Accreditation of
Laboratory Animal Care (International).
Through the Biomedical Research Infrastructure Network (BRIN), the
NIH's Institutional Development Award program enhances the educational
infrastructure and research capacities of institutions within 23
eligible States and Puerto Rico. The BRINs provide support for
laboratory renovation and scientific equipment, as well as the
recruitment and support of faculty at eligible institutions. In fiscal
year 2002, NCRR proposes to further develop the BRINs that were
initially established in fiscal year 2001. In addition, those States
that did not receive a BRIN award in fiscal year 2001 will have a
special opportunity to compete for this award in fiscal year 2002.
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 second annual performance
report which compares our fiscal year 2000 results to the goals in our
fiscal year 2000 performance plan. As performance trends on research
outcomes emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
My colleagues and I will be happy to respond to any questions you
may have.
______
Prepared Statement of Jack Whitescarver, Ph.D. Acting Director, Office
of AIDS Research
Mr. Chairman and Members of the Committee: I am pleased to present
the President's budget request for the AIDS research programs of the
NIH for fiscal year 2002, a sum of $2,501 million, an increase of $258
million above the comparable fiscal year 2001 appropriation. 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 second annual performance report which
compares our fiscal year 2000 results to the goals in our fiscal year
2000 performance plan. As performance trends on research outcomes
emerge, the GPRA data will help NIH to identify strategies and
objectives to continuously improve its programs.
The National Institutes of Health (NIH) represents the largest and
most significant single public investment in AIDS research in the
world. It supports a comprehensive program of basic, clinical, and
behavioral research on HIV infection and its associated opportunistic
infections and malignancies to better understand the basic biology of
HIV, develop effective therapies to treat it, and design interventions
to prevent new infections from occurring. This research is conducted
through intramural and extramural studies in the U.S. and around the
world, sponsored by nearly all of the NIH Institutes and Centers. Each
NIH component supports HIV/AIDS-related research activities, consistent
with its individual mission. It is the role of the Office of AIDS
Research (OAR) to plan and coordinate this research, setting the
scientific agenda and the budget necessary for this large and diverse
NIH AIDS research program.
THE EXPLODING PANDEMIC
The AIDS pandemic is the greatest international challenge of our
generation. HIV has infected more than 50 million people around the
world. AIDS already has killed more than 21 million people, surpassing
tuberculosis and malaria as the leading infectious cause of death
worldwide, according to data released by the Joint United Nations
Programme on HIV/AIDS (UNAIDS) in the ``AIDS Epidemic Update: December
2000'' and the World Health Report 2000 of the World Health
Organization (WHO). (Chart 1)
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
education, food supplies, and 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. In Africa, the epicenter of the pandemic, AIDS is
killing ten times as many people as war, sabotaging economic
development, leading to massive social breakdown, and creating a
generation of orphans. (Chart 2)
If the global spread of HIV/AIDS continues unchecked, South and
Southeast Asia, and perhaps China will follow the disastrous course of
sub-Saharan Africa. Rapid increases also are occurring in Eastern
Europe and Central Asia, and AIDS remains a serious threat in Latin
America and the Caribbean. During the year 2000, more new HIV
infections were registered in the Russian Federation than in all
previous years of the epidemic combined.
THE EVOLVING EPIDEMIC IN THE UNITED STATES
In the United States, the HIV/AIDS epidemic continues to evolve.
Although the incidence of new AIDS cases has declined, attributed
largely to expanded use of new antiretroviral therapies that prevent
progression of HIV infection to AIDS, the decline in death rates
observed in the late 1990s has leveled off. Further, according to the
Centers for Disease Control and Prevention (CDC), the rate of new HIV
infections has been constant at approximately 40,000 new cases each
year since 1990, meaning that the overall epidemic is continuing to
expand. In fact, HIV infection rates are continuing to climb in a
number of subpopulation groups, such as women, racial and ethnic
minorities, young homosexual men, individuals with addictive disorders,
and people over 50 years of age. The appearance of multi-drug resistant
strains of HIV presents a serious public health concern. These data
forebode an epidemic of even greater magnitude in the coming years, and
they shape our most urgent research priorities.
COMPREHENSIVE AIDS RESEARCH PLAN AND BUDGET
The OAR develops an annual comprehensive trans-NIH AIDS research
plan and budget to address these priorities, based on the most
compelling scientific opportunities that will lead to better therapies
and prevention for HIV infection and AIDS. The planning process is
inclusive and collaborative, involving the NIH institutes as well as
non-government experts from academia, foundations, and industry, with
the full participation of AIDS community representatives. The plan
provides objectives and strategies for the five Scientific Areas of
Emphasis of AIDS research: Natural History and Epidemiology; Etiology
and Pathogenesis; Therapeutics; Vaccines; and Behavioral and Social
Science; as well as for key Areas of Special Interest, which cross-cut
all of the scientific areas: Racial and Ethnic Minorities;
International Research Priorities; Training, Infrastructure, and
Capacity Building; and Information Dissemination. This year, the OAR
also led an NIH effort to develop a strategic plan for microbicide
research, which will become an integral part of the overall plan. In
addition, the fiscal year 2003 plan, now underway, will include a new
section devoted to research priorities for AIDS in Women and Girls. The
Plan serves as the framework for developing the NIH AIDS budget for
each Institute and Center, for determining the use of NIH AIDS-
designated dollars, and for tracking and monitoring those expenditures.
Four major themes frame the fiscal year 2002 NIH Plan for HIV-
Related Research: prevention research to reduce HIV transmission here
in the United States and around the world; therapeutic research to
treat those who are already infected; international research
priorities, particularly to address the critical needs in developing
countries; and research targeting the disproportionate impact of AIDS
on minority populations in the United States. All of these efforts
require a strong foundation of basic science, the bedrock of our
research endeavor.
PRIORITY: PREVENTION RESEARCH
The transmissible nature of HIV makes it radically different from
non-transmissible diseases such as heart disease and cancer. The
transmissibility of HIV--between individuals and across borders and
populations--is what most defines the global pandemic and makes it
imperative that the U.S. help address prevention and treatment needs
worldwide. The transmissibility of the infection means that there is
the potential for unlimited global spread. But it also means that, with
the development of appropriate biomedical and behavioral interventions,
there is the possibility for dramatic reductions in new infections--and
ultimate control of the pandemic--in a way that will not be possible
for noninfectious diseases.
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 targets
interventions to both infected and uninfected at-risk individuals to
reduce HIV transmission. Our biomedical prevention research priorities
include the development of topical microbicides, strategies to prevent
perinatal transmission-including a better understanding of risk
associated breast-feeding-and management of sexually transmitted
diseases. NIH also supports behavioral research strategies, including
prevention interventions related to drug and alcohol use and risky
sexual behaviors. Efforts continue to identify the most appropriate
intervention strategies for different populations and sub-epidemics in
the U.S. and around the world.
PRIORITY: VACCINE RESEARCH
A safe and effective HIV preventive vaccine is essential for the
global control of the AIDS pandemic. NIH funding for HIV vaccine
research increased by more than 170 percent between fiscal year 1997
and fiscal year 2002, resulting in the award of new grants to foster
innovative research on HIV vaccines, including vaccine design and
development, and the invigoration and reorganization of the NIH vaccine
clinical trials effort. (Chart 3) Construction of the new intramural
Vaccine Research Center has been completed. In February 1999, NIH-
supported investigators initiated the first AIDS vaccine trial in
Africa. The investment in this area over the past few years will have
enormous significance, not only for AIDS research but for other
diseases as well, as progress made in the development of an AIDS
vaccine will have implications for vaccines against other life-
threatening illnesses.
PRIORITY: TREATMENT RESEARCH
Today, many HIV-infected people are living with the benefits
resulting from NIH-supported research in this area. The development of
combination regimens including protease inhibitors has extended the
length and quality of life for many HIV-infected individuals in the
United States and Western Europe. Unfortunately, however, highly active
antiretroviral therapy (HAART) has failed to eradicate HIV, and a
growing proportion of patients receiving therapy experience treatment
failure. Some patients find it difficult or impossible to comply with
arduous treatment regimens, develop toxicities and side-effects, or
cannot afford their high cost of approximately $15,000 per year. Others
fail to obtain a satisfactory reduction in viral load even while
adhering to treatment regimens. In addition, metabolic complications,
including insulin resistance, and body composition changes such as
deforming deposits of abdominal adipose tissue, have emerged in
individuals who have been on long-term antiretroviral regimens.
Finally, an increasing number of treatment failures are linked to the
increasing emergence of drug-resistant HIV. Thus, the need for simpler,
less toxic, and cheaper drugs and drug regimens to treat HIV infection
and its associated opportunistic infections (OIs), malignancies, and
other complications, continues to be a high priority. (Chart 4)
PRIORITY: INTERNATIONAL RESEARCH
To address the increasing urgency of the global AIDS pandemic, the
OAR has established a new initiative and strategic plan for global
research on HIV/AIDS aimed at slowing the disaster and reversing its
destruction of communities, economies and nations worldwide. The Global
AIDS Research Initiative and Strategic Plan reaffirms NIH's long-
standing commitment to international AIDS research and will
significantly increase research efforts in the coming year to benefit
resource- and infrastructure-poor nations. NIH supports a growing
portfolio of research conducted in collaboration with investigators in
developing countries. Results of this research benefit the people in
the country where the research is conducted as well as people affected
by HIV/AIDS worldwide. It is critical to the success of international
studies that foreign scientists be full and equal partners in the
design and conduct of collaborative studies and that they have full
responsibility for the conduct of studies in-country. To that end, NIH
supports international training programs and initiatives that help to
build infrastructure and laboratory capacity in developing countries
where the research is conducted.
PRIORITY: RACIAL AND ETHNIC MINORITIES
Research to address the disproportionate impact of the HIV/AIDS
epidemic on U.S. racial and ethnic minority communities (Chart 5)
continues to be a high priority. We are directing increased resources
toward new interventions that will have the greatest impact on these
groups. These include interventions that address the co-occurrence of
other STDs, hepatitis, drug abuse, and mental illness; and
interventions that consider the role of culture, family, and other
social factors in the transmission and prevention of these disorders in
minority communities. NIH is making significant investments to improve
research infrastructure and training opportunities for minorities, and
we will continue to assure the participation of minority subjects in
AIDS clinical trials as well as in natural history, epidemiologic, and
prevention studies. 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.
One of these projects is a series of Training and Career Development
Workshops for racial and ethnic minority investigators.
PRIORITY: BASIC SCIENCE
Of paramount importance in our fight against HIV/AIDS is
maintaining a strong commitment to basic research. Tremendous progress
has been made in understanding the fundamental steps in the life-cycle
of HIV, the host-virus relationship and the clinical manifestations
attending HIV infection and AIDS. Groundbreaking research on basic HIV
biology and AIDS pathogenesis has revolutionized the design of drugs,
the methodologies for diagnosis, and the monitoring for efficacy of
antiviral therapies. Thus, OAR will continue to devote a substantial
portion of NIH AIDS-related research funds to fundamental biomedical,
behavioral, and social science research.
SUMMARY
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 world. The
nation's investment in AIDS research is reaping even greater dividends,
as AIDS research is unraveling the mysteries surrounding many other
infectious, malignant, neurologic, autoimmune and metabolic diseases.
We deeply appreciate the support of this Committee for our efforts.
THE EXPLODING GLOBAL HIV/AIDS PANDEMIC
[In millions]
------------------------------------------------------------------------
People People
newly living AIDS Total
Group infected with HIV/ deaths in AIDS
in 2000 AIDS 2000 deaths
------------------------------------------------------------------------
Adults...................... 4.7 34.7 2.5 17.5
Women....................... 2.2 16.4 1.3 9.0
Children.................... .6 1.4 .5 4.3
===========================================
Total................. 5.3 36.1 3.0 21.8
------------------------------------------------------------------------
Source: UNAIDS
Senator Specter. We have been joined by my distinguished
colleague, Senator Thad Cochran.
Senator Cochran, do you care to make an opening statement?
Opening statement of Senator Thad Cochran
Senator Cochran. Well, Mr. Chairman, thank you. I join you
in welcoming Dr. Kirschstein thanking her in joining us for
this discussion of the budget for the fiscal year 2002 for NIH.
I think she deserves our commendation, too, for her service
to the National Institutes of Health, particularly during this
recent transition period, but this budget is a very important
step toward our goal of doubling the NIH budget by the year
2003. It addresses very oppressing health needs in our country,
and around the world, as a matter of fact.
There are two areas I hope to see the Institutes address
during this year. We have to deal with the disparities in
under-served areas of our country, as well as funding
disparities. The IDeA program is one way of enhancing research
effort in my part of the country, where NIH research has not
traditionally been conducted. It is interesting to note that
these are also some of the same areas with glaring health
disparities. The IDeA program has the potential to improve the
health of millions of needy patients in these areas.
An additional area of concern for me is bio-imaging and
radiology research. The newly authorized National Institute of
Bio-Imaging and Bio-Engineering will require a transfer of
existing radiology and bio-engineering research to this new
institute. We are looking forward to working with you and
helping to provide you the benefit of our counsel and advice.
Thank you again for being here, and for your dedicated work for
millions of Americans.
Thanks, Mr. Chairman.
Senator Specter. Thank you very much, Senator Cochran.
Dr. Kirschstein, a question which is repeatedly posed to me
by my colleagues is, are we providing too much money too fast
to the National Institutes of Health. What are your best
assurances, as specific as you can be, that this rapid increase
in your budget is being put to good use?
Dr. Kirschstein. Mr. Chairman, the scientific opportunities
are immense, and they have been for some time. The increases
that the Congress has provided to the National Institutes of
Health have been put to extraordinarily good use over the last
several years.
Programs in clinical research that could not possibly be
started before have been begun, in drug abuse, in heart
disease, new testing of vaccines, new testing of therapies for
HIV AIDS, new studies in cancer. Dr. Klausner can describe
several new drugs that have been developed, as can all my
colleagues.
The momentum is there. What is needed is to continue to
make progress, because every question that is answered leads to
several more questions that need to be answered, and this is a
moment of enormous opportunity.
Senator Specter. Is $3.4 billion sufficient to utilize and
follow all of the existing leads?
Dr. Kirschstein. Mr. Chairman, I think that the increase
that the administration has given us is very fine, indeed. It
is 13.5 percent, $3.4 billion would be even more, clearly, but
I think we could use those funds extremely well. We have
investigators who are full of burgeoning ideas. We have
clinical trials that we want to do.
We need to do some work in the states that Senator Cochran
is talking about. Our BRIN program has been started, and the
Senator knows. I came down and saw him last week, and we have
all sort of wonderful opportunities. I would like to give my
colleagues a chance to tell you about them, if possible.
Senator Specter. You pick the first colleague to give us as
specific an illustration as he or she can as to what this
additional funding has meant.
Dr. Kirschstein. Dr. Klausner.
Senator Specter. We heard from Dr. Klausner 10 days ago,
and we know his answers.
Dr. Kirschstein. In that case, I will go to Dr. Lenfant.
Either way.
Senator Specter. Go ahead, Dr. Klausner.
Dr. Klausner. Senator, just in case you forgot, over the
last couple of years, with the increase in funding, we have
been able to do a variety of things, including beginning to
change the entire way cancer is diagnosed, as we talked about a
few weeks ago, switching from a hundred years of pathologic
diagnosis alone, to the new molecular diagnosis.
We are suddenly discovering rapidly that there are new
types of cancers that we only imagined exist, we now see exist.
For the first time, with that, we can align therapies to the
appropriate diagnosis.
Senator Specter. Dr. Klausner, you testified at the hearing
on breast cancer about the impact of stem cells. I think it
would be good for you to summarize that here this morning.
Dr. Klausner. Yes. What I pointed out is that in cancer we
believe that there are two types of opportunities in stem
cells. Of course, in cancer research we have been using stem
cells to replace organs, generally, the bone marrow, that are
damaged, either because of disease, or, more commonly, therapy.
The two areas of promise with stem cell research for cancer
are, one, understanding the fundamental biology which underlies
cancer, and that is, how do cells make the decision to either
keep proliferating, or to differentiate. That fundamental
switch which underlies stem cell biology is, we believe,
fundamental to understanding the switches that lead to cancer
cells.
The other issue in cancer is the fact that until we have
better therapies currently, cancer itself, or the therapies,
are often quite destructive of tissues, or particular organs,
and stem cells, as they have been used successfully in cancer
therapy, hold the promise of regenerative approaches to deal
with the damage due to therapy or the disease.
ADULT STEM CELL EXPERIMENT
Senator Specter. Dr. Lenfant, I am turning to you next. As
Dr. Kirschstein suggested. Thank you for the response to my
letter, in which you had pointed out that in the next 5 years
it's projected that there will be an ability to engineer
tissues for damage heart valves, muscles, and blood vessels,
and the delivery of therapeutic genes, and in 10 years,
projecting complete heart ventricles, regeneration of cardiac
tissue, and organ growth in infants born with cardiovascular
malformations. That is very good news, indeed. To what extent
do the stem cells play a part in that?
Dr. Lenfant. Well, so far, Mr. Chairman, we have been
developing a fairly significant experiment in the use of adult
stem cells and the results have been extraordinarily exciting
and significant, as to what you were mentioning, the recreation
of tissues which have been damaged, and quite successfully in
the formation of new valves, new blood vessels. And in the case
of, say, heart failure, which is the ultimate complication, so
to speak, of the repeated heart attack, we can now regenerate
some heart cells, and restore some of the functionality of the
myocardium, which has been damaged by a repeated heart attack.
Senator Specter. Why do you particularize adult stem cells,
Dr. Lenfant?
Dr. Lenfant. Excuse me?
Senator Specter. Why did you specify adult stem cells?
Dr. Lenfant. Because so far that is the only experience
that we have, Mr. Chairman.
Senator Specter. Have you not had stem cells available from
embryos?
Dr. Lenfant. No. No. Not in our areas of research. They
have not been used.
EMBRYONIC STEM CELL POTENTIAL
Senator Specter. We have had expert testimony that
embryonic stem cells offer a great deal more flexibility and
ability to differentiate that is much superior to adult stem
cells. Would you agree with that?
Dr. Lenfant. Yes, I would agree with that. In my scientific
opinion, it is something that needs to be explored, but so far
it has not been done, and all the comments that I can make are
on the basis of what we have learned from other stem cells.
Senator Specter. Well, I think it is very good news,
indeed, to people who have heart disease what you have
accomplished, and what you have the prospects to accomplish
beyond.
My red light went on, so I will turn to my colleague,
Senator Cochran.
Senator Cochran. Mr. Chairman, I have some specific
questions about the IDEA program, and some other issues, which
I am prepared to submit for the record, and let you move along.
You have a lot of people here, and I have another commitment
that requires me to leave now, but I appreciate your conducting
the hearing, and having everyone here for the committee.
Senator Specter. Thank you very much for joining us,
Senator Cochran. I appreciate it.
The issue of stem cells, I know, has been very much in the
forefront of Parkinson's. Dr. Audrey Penn, a question that I
have asked in each of our previous sessions has been ``When,''
and we had an estimate within 5 years to conquer Parkinson's.
In light of all of the money you have gotten for research, how
far can you advance that completion date?
That is what you call a leading loaded question, Dr. Penn.
You can handle it any way you like.
Dr. Penn. I hope we can advance it. There are two responses
to your question on record. One was 5 years and one was 10
years, I will not claim either one, but we feel that we are
moving very quickly on measures that will control this disease
much better than we have ever done before. A cure is going to
be harder, as we know, and it will take a little longer. There
are several issues.
In terms of the stem cell question, we have evidence
already using stem cells or precursor cells in mouse models
that we can really impact the types of models of Parkinson's
Disease that we already have, these are chemically induced
models, but the response is tremendous.
We have not yet moved beyond that, and there may be another
way. There may be a way of using the cells already resident in
the brain to mobilize them. There is already evidence that that
can be done. We hope that we can do this, because it solves
things like gene therapy, it solves things like putting special
factors in that could help those cells that are left to work.
We very much think that this is a way of approaching the
problems we are having in really curing this disease.
Senator Specter. Let me move quickly to a couple of other
questions----
Dr. Penn. Yes, sir.
Senator Specter [continuing]. Dr. Penn. Amyotrophic lateral
sclerosis, what is the progress there, and to what extent are
the stem cells implicated there?
Dr. Penn. I would say, sir, that there is a group organized
by private donors that are very much involved in doing just
this, and they are making progress working with some of the
best investigators in the country.
Senator Specter. On stem cells----
Dr. Penn. They are monitoring this. They are working with
stem cells.
Senator Specter. And they are private donors?
Dr. Penn. They are private donors, and they have a very
specific target, as you can well imagine.
Senator Specter. What are the prospects for delaying the
onset of ALS?
Dr. Penn. I do not know that this approach will delay the
onset, but it certainly could put back working motor neurons,
so that this disease could be slowed way down. The whole group
in the amyotrophic sclerosis community is very much involved in
doing clinical trials.
They want to do clinical trials as soon as possible with
almost anything that will work, so they are organized and
mobilized. We are still trying to put pertinent factors back in
the spinal cord, but there is some very interesting evidence
that stem cells may work.
Senator Specter. And Alzheimer's comes within your branch
as well.
Dr. Penn. Yes, it does. Again, Dr. Hodes and NIA is the
primary institute dealing with Alzheimer's disease.
ALZHEIMER'S DISEASE RESEARCH
Senator Specter. Well, let me turn to him then, sort of
spend around the speaking parts, and ask you, Dr. Hodes, for
your evaluation as to what progress we are making on
Alzheimer's, and to what extent the research is moving ahead,
and if stem cells factor in there.
Dr. Hodes. Thank you for the opportunity. If you will
remember, we had the chance to speak with you before a hearing
here not so long ago, during which there was a summary of the
very dramatic progress in Alzheimer's research over the past
years. The identification of genetic and molecular
underpinnings of the disease has very directly been translated
now into new approaches to treatment.
They include attempts to actually interfere with some of
the molecules, enzymes that cause some of the toxic products in
the disease. You heard in particular about an approach to
immune therapy, or vaccination, against Alzheimer's peptide,
that is very exciting.
In terms of the role of stem cells, there has been very
exciting news over the past year indicating that in some of the
areas of the brain that are affected by Alzheimer's, there is,
indeed, stem cell activity, the sort Dr. Penn referred to, that
is stem cell activity resident within the brain. One approach
is to try to trigger differentiation of these very cells in the
brains of individuals affected, and repair damage caused.
In addition, there is work that has been occurring in
animal models in which cells from a variety of sources
unexpectedly have been shown to have the capacity, for example,
bone marrow stem cells, to differentiate into stem cells for
neurons, which can, indeed, repopulate the brain. So these are
some very recent and exciting findings, which suggest that stem
cells from a variety of sources may be capable of
differentiating into functional neurons in the brain, and
provide relief, or even prevention for Alzheimer's disease.
Senator Specter. Let me turn now to Dr. Allen Spiegel,
Diabetes Institute. The question is: I understand that the stem
cells have been very instrumental in moving ahead on diabetes.
Can you bring us up to date on that, please?
ISLET TRANSPLANTS IN TYPE 1 DIABETES
Dr. Spiegel. I would be happy to, Chairman Specter. As you
know, and as we discussed with your colleague, Senator Harkin,
the Edmonton trial in Canada has demonstrated that islet
transplantation can be a successful potential cure for type 1
diabetes. The follow-up for this trial was updated just in
April in a paper published in the journal Diabetes, which
indicated that 11 of the 12 people receiving these islet
transplants are still insulin independent. This is very
promising.
This protocol is being replicated in NIH-supported studies
around the country, and at the NIH Clinical Center there has
already been experience with four such patients, again, showing
some success.
INADEQUATE SUPPLY OF ISLETS
This is the good news. However, roughly 1,000 donor
cadaveric pancreases, from which these islets are harvested,
are insufficient to ever meet the need for the roughly million
type 1 diabetics. This is why we are working intensively on
many, many approaches to providing the supply of islets. Stem
cell work is very important in this regard.
STEM CELL RESEARCH
I will summarize briefly some of the progress to date of
which I am aware. Mouse adult stem cells, derived from the
pancreatic ducts, have been used in an experimental study
published in Nature Medicine to reverse type 1 diabetes in the
mouse model. That has not been replicated, and there have been
some concerns as to whether there are really adequate amounts
of insulin produced.
In human efforts for adult stem cells coming from the
pancreatic duct, investigators at the Joslin Clinic, whom we
support, have isolated such adult stem cells that can turn into
islets, but unfortunately, the amounts, to date, are
inadequate.
Senator Specter. The amount of what is inadequate?
Dr. Spiegel. These cells are precursors in the pancreatic
ducts from adult pancreases that are cadaveric pancreases,
grown into islet-like clusters, and unfortunately, the amounts
generated, according to the investigators in that paper, are as
yet inadequate to be useful.
Senator Specter. The amount of adult stem cells?
Dr. Spiegel. That is correct, according to those
investigators.
Senator Specter. Do you concur with Dr. Lenfant that the
embryonic stem cells would be superior?
Dr. Spiegel. I cannot give you a simple answer to that, but
I can tell you about work on mouse embryonic stem cells, which
is what I was coming to.
The mouse embryonic stem cell work, which can be supported
by NIH, was actually done intramurally in the National
Institute of Neurological Disorders and Stroke. Researchers
demonstrated in a very, very exciting fashion that they could
differentiate these mouse embryonic stem cells into islet-like
clusters. Unfortunately, these cells made about a fiftieth of
the amount of insulin of a normal beta cell, and they were
inadequate to be able to cure diabetes in a mouse model. This
is work of Dr. Ron McKay and colleagues, published in Science.
As far as human embryonic stem cell work, undoubtedly it is
going on in the private sector, perhaps in foreign countries,
but because there are no publications that I am aware of, I
cannot really comment.
Finally, I would comment on the work with bone marrow stem
cells. We have heard so much about their plasticity--the fact
that they can turn into so many other kinds of stem cells.
However as yet, to my knowledge, there is no evidence that they
turn into islet cells--liver cells, possibly, but not islets.
In summary, we just do not know at this very early stage of
investigation which of the two types of cells--adult stem cells
or embryonic stem cells--would be superior. I think, as a
scientist, that one has to be cautious and not make
pronouncements when there is no sort of adequate data yet.
Senator Specter. Would you like to have the availability of
embryonic stem cells to at least find out?
Dr. Spiegel. That is something that is under review by the
Administration, and I think we will have to see how that works
out.
Senator Specter. Excuse me, but what does that have to do
with my question, what the administration wants to do? I am
asking you as a scientist, would you like to have embryonic
stem cells available.
Dr. Spiegel. What I can certainly say is that a number of
scientists, I think there were 80 Nobel Laureates, that I am
aware of, have articulated the desire to be able to compare
these. I think scientists around the country in the various
centers have said exactly that. As a scientist, yes, I think we
would like to be able to do this.
Senator Specter. That is what I was looking for, as a
scientist.
Dr. Spiegel. Yes, absolutely, as a scientist, that is
absolutely the case.
USE OF STEM CELL IN VISION RESEARCH
Senator Specter. Let me move quickly before yielding to
Senator Harkin and get some comments from Dr. McLaughlin, of
the Eye Institute, with the focus on new cornea studies showing
promise with stem cells. Dr. McLaughlin, how about that?
Dr. McLaughlin. Yes, sir. That is probably, in the eye,
field the most advanced situation for stem cell
transplantation. In conditions such as alkaline burns, where
the normal cells that would lead to the clear cover----
Senator Specter. Speak more directly into the microphone,
please, Dr. McLaughlin.
Dr. McLaughlin. The cornea of your eye is covered by a
single layer of cells, and this is very important. If those
cells are unhealthy, your cornea will cloud, and you will not
be able to see. In situations, for example, like an alkaline
burn, the cells that normally would produce those, that single
layer of cornea cells, they are destroyed.
So what investigators are doing, they are taking cells--
this is from adults--that are stem cells, or precursors to
those cornea cells, growing them up in culture, and then
transferring them to patients who have these various corneal
problems, and so far the results are very promising.
Senator Specter. Let me turn now to Dr. Stephen Katz,
National Institute of Arthritis, Musculoskeletal and Skin
Disease, with respect to the stem cell treatment on arthritis,
which, as I understand it, shows promise on pre-growth of skin,
what is your view of that, Dr. Katz?
Dr. Katz. Thank you, Senator. In all of the areas of the
interest of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases stem cells have shown promise
including regenerating cartilage cells in the joint in
osteoarthritis, which is the most common form of arthritis. In
the area of osteogenesis imperfecta, stem cells have been shown
to be effective in regenerating some of the bone-forming cells.
In the muscular dystrophies, stem cells in work that has
been supported by the Neurology Institute, as well as our
institute, have shown promise in what are called satellite
cells, which are thought to be stem cells of muscle, to
regenerate those muscle cells. We know also that in skin, stem
cells are very important, as Dr. McLaughlin said, to regenerate
epithelium that covers the skin.
Senator Specter. Let me turn now to Dr. Anthony Fauci,
Allergy and Infectious Diseases, with respect to the stem cell
treatment on AIDS.
Dr. Fauci. Senator--thank you for the question.
One of the characteristics of HIV/AIDS disease is a rather
dramatic and catastrophic depletion of immune system functions,
specifically a very important cell of the immune system.
Similar to the reconstitution of bone marrow that Dr. Klausner
alluded to just a few moments ago in patients who are treated
for cancer, the same would hold true with regard to the
reconstitution of the human immune system by stem cells. Stem
cell research is very much at the forefront of the ideas of
individuals who are planning strategies. Once you get the virus
under control with anti-retroviral therapy, to help the immune
system, which might not be able to spontaneously regenerate
itself, it may be possible to help the immune system to
regenerate itself by providing it with these precursor cells.
Senator Specter. Dr. Kirschstein, let me come to this
question about their letters and the late arrival, and then I
will turn to my distinguished colleague, Senator Harkin.
We did not get the responses until yesterday afternoon at
3:45. There were 42 pages, as I understand it, instead of 70.
Why such a late return?
Dr. Kirschstein. Mr. Chairman, the Institute directors
received your letter on May 4th, and they were assigned for
completion to the various institutes, to be returned to the
central focus, the Executive Secretariat of NIH, by May 9th. I
met you at the event for the Society for Women's Health, and
told you, as I had told Ms. Taylor, that I was going to send
those letters for clearance, which is the policy, to the
department.
Our responses, except one, which was delayed, were sent to
the department for clearance on May 14th, and we did it--by the
way, we always send such responses through the NIH Executive
Secretariat, from our Executive Secretariat. At that point, the
work was to be done, whatever, in the department for clearance.
Senator Specter. Well, I am told that the letters were
rewritten in the department, is that true?
Dr. Kirschstein. Yesterday, I was called, and asked whether
the letters, which had been reviewed, when there was an issue
as to whether letters from individual Institute directors
raised issues more broadly than the mission of that institute,
would the Institute directors consider narrowing their focus to
their own mission, and talking strictly about the scientific
aspects, which is what I think we always address.
I had a meeting with the Institute directors, and asked
each of them to review what they had said, and see whether they
wished to, in any way, modify the letters, based on whether
they thought their letters were more broad ranging. The letters
were then----
Senator Specter. Whether their letters were what?
Dr. Kirschstein. More broad ranging than focusing on the
particular mission of the Institute. Each of the Institute
directors then reviewed their letters, and some made changes,
and some did not.
Senator Specter. Well, this subcommittee would like to get
copies of the original letters and a copy of the modifications.
It has been reported to me that the instructions were given,
quote, ``The answers and questions based on science, and not on
political speculation or personal views,'' closed quote. Is
that accurate?
Dr. Kirschstein. It was not on speculation, but it was on
following the mission of the Institute. The term ``personal
views'' was never told to me; it was never mentioned to me.
Senator Specter. Mr. Whitaker, Assistant Secretary for
Legislative Affairs, I understand, is present. Would he step
forward, please?
Come up front. We can make a place for you at the head
table.
Mr. Whitaker. Okay.
Senator Specter. Why the long delay, Mr. Whitaker?
Mr. Whitaker. Honestly, Mr. Chairman, first of all, I want
to apologize to you for the delay, but I also want to assure
you that there was in no way an attempt on the Office of the
Secretary's part to withhold information or control the
information that was sent to you.
[Clerk's note.--Page 27-32--Mr. Whitaker's office,
Assistant Secretary for Legislation, informed ASMB that the
letters and an explanation concerning the distribution of the
letters were sent to the Committee the end of May, we were not
informed of the exact date.]
Senator Specter. Well, I am interested in your
conclusions--
Mr. Whitaker. It was simply----
Senator Specter [continuing]. But only a little. Let me
find out what the facts are here. Why the delay? What happened?
Were those letters submitted on May 14th, as Dr. Kirschstein
testified? Why the delay?
Mr. Whitaker. I was told by our Executive Secretariat,
which is the part of the Department that controls
correspondence for the entire department----
Senator Specter. And who is that?
Mr. Whitaker. Anne Agnew is our executive secretary. Some
of the letters were received on the 14th, but not all the
letters, and that she----
Senator Specter. But not what?
Mr. Whitaker. Not all of the letters were received on the
14th from the Institute directors.
Senator Specter. Is that true, Dr. Kirschstein?
Dr. Kirschstein. I believe, from what I know, that all of
the letters, except one, were received on the 14th. The
National Cancer Institute was working on its letter, and it
came in 1 day later.
Senator Specter. So one letter was 1 day late, is that so,
Mr. Whitaker?
Mr. Whitaker. That is not what I have been told by the
Executive Secretariat. I do not control that information. The
information is only passed on to me. I am told that the final
letter did not come in until----
Senator Specter. I want you to pursue that and find out
whether Dr. Kirschstein is correct or not----
Mr. Whitaker. Yes.
Senator Specter [continuing]. And submit a written response
within a week, please.
Mr. Whitaker. I will do that, sir.
Senator Specter. So how about the letters that were
submitted? Why were they not transmitted to the subcommittee?
Mr. Whitaker. As a matter of policy, the Secretary has
asked for the right to review correspondence to Congress, as
well as testimony to Congress, and those letters were received
in the Office of Legislation on Thursday night, and on my desk
on Friday evening.
Senator Specter. Which Thursday and which Friday?
Mr. Whitaker. This past Thursday. The date would have been
the 17th. Then I saw the letters the following Friday evening.
Senator Specter. What happened to them between Monday and
Friday?
Mr. Whitaker. I do not know, sir. The letters were----
Senator Specter. Would you find out for me?
Mr. Whitaker. I will find out. My assumption is that the
letters were at the Executive Secretariat's office, and they
were probably being compiled so that they had a complete
package to forward to the Office of Legislation. That is my
guess as to----
Senator Specter. Were there any requests made for
modification by----
Mr. Whitaker. We made no specific requests to modify any of
the letters. We simply asked----
Senator Specter. Aside from a specific request, did you
make a generalized request?
Mr. Whitaker. We made a generalized request that we thought
it would be best that the letters be focused on the science,
and the science only, and that----
Senator Specter. Well, what were the letters focused on,
that these scientists were not writing the letters based on
science?
Mr. Whitaker. I believe, and Dr. Kirschstein talked to me
about this, and to our chief of staff, and Dr. Kirschstein
agreed, that some of the letters may have gone beyond exactly
what the mission of each institute was, and based on some non-
scientific speculation, and Dr. Kirschstein----
Senator Specter. These letters had non-scientific
speculation.
Mr. Whitaker. That was my understanding from my
conversation with Dr. Kirschstein.
Senator Specter. Would you make available to this
subcommittee the specifics as to what you are talking about,
what letters you received, and what you considered non-
scientific speculation?
Mr. Whitaker. As a general rule, sir, we receive draft
letters from all agencies, from HCFA, to AOA, to NIH, to CDC,
for review. These come to us in the form of draft letters for
us to review, and that is general policy----
Senator Specter. I am not so much interested in that as I
am in response to my question. Will you submit to this
subcommittee the letters which you concluded were based on
speculation?
Mr. Whitaker. I will go back and look at those letters,
sir, and I will get a response to you.
Senator Specter. Will you submit those letters to this
subcommittee?
Mr. Whitaker. I would be happy to do that, sir. I obviously
would have to clear that with the Secretary.
Senator Specter. Well, let me be direct in my concerns
here. This subcommittee is interested in what the potential for
stem cells may be, and we want the scientific facts. When I get
a report that the answers to my questions are based not on
science, but on political speculation and personal views,
closed quote, I am more than a little concerned. This would be
an indication of the kind of scientists which we have here, if
the responses were not based on science.
If you, top-flight men and women, do not respond to the
subcommittee based on science, I have a hard time understanding
why we are appropriating $24 billion for you. You are
scientists, and I would expect you to submit answers based on
science, and I would be shocked if you did not, because I know
your caliber and your qualifications.
So I want to see what those responses are, whether they are
based on science, or maybe some of you did not like the
answers. Then when it goes on to say not on political
speculation, well there is no place for politics in the work in
your unit, and I want to know what the facts are on stem cells.
I have had a discussion with the President of the United
States on this subject, and he wants to know what the facts
are, too, and we want them unvarnished. I talked twice to the
Secretary of Health and Human Services about this matter. I was
not very happy, at mid-day, the day before this hearing, not to
have those letters.
There are other things on my agenda between yesterday
afternoon and this morning, like voting in the United States
Senate on the tax bill. So I intend to get to the bottom as to
what is going on here. Really the basic consideration is what
is the potential for stem cells.
There is a political fight brewing over this matter, and it
is going to be decided in the Congress and by the President.
When we have these extra embryos created for in vitro
fertilization, and they create more embryos than necessary.
Some are going to be destroyed, and there is an argument, a
theological, philosophical, political argument about whether
life is in existence. If life were to be created, I would be
the last one to say let us use these embryos for stem cell
research, but if they are going to be destroyed, it is another
matter. But that is something to be decided in the Congress and
by the President in accordance with our laws.
We can pass a bill, he can sign it or veto it, and we can
override the veto, if there are two-thirds necessary. That is
the way these judgments are made, but from you we would expect
the facts and the scientific evaluation. And from you, Mr.
Whitaker, and your department, we would expect the transmission
without editing and alteration, but we will get the details as
to what was originally submitted, and whatever objections you
had, and we will make our own evaluation of that.
Senator Harkin.
Senator Harkin. Thank you very much, Mr. Chairman. I will
just ask that my statement be made a part of the record.
[The statement follows:]
Prepared Statement of Senator Tom Harkin
Thank you, Mr. Chairman. You've been a great champion for medical
research over the years, and I thank you for holding this hearing.
Dr. Kirschstein, it's a pleasure to welcome back you and your
colleagues to testify before this subcommittee. Most people probably
don't realize how important your work is to their daily lives, and how
lucky they are that you do it so well. But all of us on this
subcommittee are grateful for your extraordinary dedication and
service.
A lot has happened since we met last spring to discuss the NIH
budget for fiscal year 2001. Two months after that hearing, NIH
scientists announced the completion of a draft sequence of the human
genome--without a doubt, one of the most significant events of our
lifetime.
And just two weeks ago, the NIH made another exciting announcement:
the FDA approval of the most promising cancer drug ever developed. This
drug, called Gleevec, was given to 54 patients with chronic myelogenous
leukemia (CML), a disease in which too many white blood cells are made
in the bone marrow. In 53 of those patients, the disease basically
disappeared. A year later, 51 of those patients still had a normal
blood count.
One thing that's so exciting about this drug is its potential for
fighting other diseases as well. As I understand it, Gleevec turns off
the same molecular targets that also cause some forms of cancer in the
abdomen and brain. It's hard to believe that a single drug could work
against three cancers that seem so different on the surface, but that
seems to be a real possibility.
And if it's true, we might have to re-evaluate the way we think
about the nature of disease itself. Instead of describing a disease by
where it shows up in the body--the liver or the brain or the lung--the
key issue is really what part of the molecule is causing the problem.
This is exactly the kind of discovery that the NIH is all about.
First, scientists did basic research about how molecules work; then
they translated it into a direct application that could save thousands
of lives.
And it's an encouraging sign to those of us on this subcommittee
who have supported the NIH over the years. When I first started talking
about doubling NIH's budget back in the early 1990s, most people didn't
take that idea very seriously. Now, thanks to the work of Chairman
Specter and many others, it's on the verge of happening. Next year,
fiscal year 2002, will be Year 4 of our five-year effort to reach that
goal.
The president has called for a $2.7 billion increase, but Chairman
Specter and I would like to boost that figure up to $3.4 billion. Of
course, our ability to do that will depend greatly on what kind of
appropriations allocation we get; we certainly weren't helped by the
budget resolution that Congress adopted earlier this month. But I'm
hopeful we'll prevail.
And if we do, Dr. Kirschstein, I don't need to remind you that the
additional money will bring added responsibilities--$3.4 billion means
a lot more grants to award, a lot more clinics to staff, and a lot more
employees to manage. It will take a great deal of vigilance to ensure
that the money is spent wisely.
Again, Mr. Chairman, I want to thank you for holding this hearing,
and I look forward to Dr. Kirschstein's testimony.
Senator Harkin. I want to welcome Dr. Kirschstein and all
of the other directors, the scientists and administrators who
are here today.
First of all, let me just say for the record, Mr. Chairman,
you have been one of the great leaders in the entire Congress
in pushing for medical research all the time I have known you,
and all these years, and I just want you to know that I
appreciate that, and I thank you for that, and I thank you for
holding this hearing, and for your strong support of unbiased,
non-political interference in scientific pursuits, and I want
to thank you for that.
I just want you to know, I have just been listening to
this, and I know a little bit about this. If at any time that
you would like to issue a subpoena to go back and get those,
you will have my name on it.
Senator Specter. Thank you.
Senator Harkin. I would be glad to support you in that, if
you would like to do that, if that becomes necessary. If that
becomes necessary, I will support you.
I was just thinking, again, Mr. Chairman, that years ago we
had a lot of political interference in terms of the budget
coming up, especially from the National Cancer Institute. This
is a number of years ago, preceding me. So the Congress passed
a law mandating a by-pass budget. So every year we get a by-
pass budget that we get our hands on directly from the
Institutes.
Well, maybe, Mr. Chairman, what we need to do is to ensure
that any requests for letters from any of the heads of any of
the Institutes that we request that comes to this appropriation
subcommittee also has a by-pass that comes here, just like the
by-pass budget.
Now, if the political people, in whatever department, and
whatever administration, want to tinker with it, that is their
own business, but at least we should get the unvarnished truth
without going through it, so maybe we ought to think about how
we--if we ask, if this committee, you as chairman, me ranking
member, whatever, asks for information from an institute, that
ought to be transmitted, and it should not have to go through
other kinds of departments, just like a by-pass budget, and
maybe we ought to think about----
Senator Specter. Good point.
Senator Harkin [continuing]. Changing the law in that
regard. We have a vote on, and I am sorry, I apologize, we are
going to have all these votes, and so I assume we are going to
have to go, right?
I just want to thank all of you for all of the tremendous
work you are doing in scientific research, the great leadership
you have shown. I wish we could have more time to go into a lot
of these things. I have as much support for stem cell research
as my chairman does, and we are pretty much in lock step on
this one.
A couple of things, and you do not even have to answer
this, but I perhaps need it in writing, Dr. Kirschstein, is, we
have been working hard to double the budget, we are going to
get it done, it is going to happen over the next couple of
years, but the President's budget, looking in the forward
years, calls for a 2.2 percent increase in 2004 and a 2.2
percent increase in 2005.
Now, that has important implications, because research
grants run about 4 years, and we want them to run longer than
shorter periods of time, so new grants that are awarded now
will require commitments through 2005. But if we come to a
ledge and we drop off, what is going to happen if, in fact,
there will not be any money left over for anything new?
In other words, if we use all that money for all the old
grants, what happens to the new grants that we want to start
funding in those out years? I am really concerned about that,
and I do not--we have to go. I do not know if you can respond
to that shortly, and----
Dr. Kirschstein. I can give you a short answer, Mr. Harkin.
We are concerned, also, and so we are beginning to look at
this, and, indeed, I am putting together a committee of
Institute directors. Dr. Lenfant will chair the committee. We
will have other Institute directors. We will have Dr. Baldwin,
who handles the day-to-day activities of our extramural
research program, and we will be working on this steadily, and
we will have some plans sometime by the summer.
Senator Harkin. Okay. Two other quick things: The status of
our labs out there and extramural research. I will not go into
all of the studies and all of that data, but I am just going to
say that right now it is authorized at $250 million, and given
the current situation, would it make sense for the NIH to spend
more than $97 million out of that $250 million that is
authorized? So take a look at that, will you, for me?
Dr. Kirschstein. We will, Senator.
Senator Harkin. I think we need to look at that a little
bit longer, closer.
The last thing is--there are a lot of things I would like
to get into. Gleevec, what a great breakthrough on cancer
research on this drug, it seems to me. We have talked about it
before, but the question I have is: How much of NIH's research
went into that, supported, NIH-supported research went into
that?
Dr. Klausner. The reality is, that a larger amount of the
underlying research that led to understanding the drug target
has been supported by NIH-funded research, starting back in
about 1960.
Senator Harkin. Now, Rick, you know what my next question
is. When I talked about--I was in my home state, and we were
talking about this new drug, and this new candidate, and it
looks like it has maybe applications for other types of
cancers, too----
Dr. Klausner. It does.
Senator Harkin [continuing]. But then the news reports
carried the report that it would come in at around $2,000 or
$3,000 a month, to which one person said, ``That is wonderful.
I cannot use it. How are you going to pay for it?''
So I am just wondering about the pricing of this, and
whether or not there is some recapture, or something like that.
We have to figure this one out, about what we do about the
pricing, and if it is that expensive, how much comes back into
NIH to help us out. I do not know, but I--that is coming down
the road. If you want to respond to that, fine.
Dr. Klausner. We, of course, are not involved in the
pricing of a particular drug.
Senator Harkin. I understand that. I understand that.
Dr. Klausner. But we really are very concerned about making
sure--that individuals, individuals that need drugs, have
access to those drugs.
Senator Harkin. Yes. Well, this is something I think we, up
here, are going to have to figure out on what we want to do on
that, but I just wanted to mention it. We have 4 minutes left.
Thank you, Mr. Chairman. Three minutes.
Senator Specter. Thank you all very much for coming. I am
always reluctant to take the time of this many distinguished
scientists who could be back in the laboratory moving ahead.
America is very fortunate to have such an extraordinary
organization like the National Institutes of Health.
You have heard me say on many, many occasions that you are
the crown jewel of the Federal Government. I stopped saying you
are the only jewel of the Federal Government--I have had too
many complaints about that--but we thank you for what you are
doing.
Senator Harkin and I will continue to fight hard to bring
you more resources, and I think you will have the backing of
the Congress and the President.
Thank you.
Dr. Kirschstein. Thank you, Mr. Chairman.
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
ndri expansion
Question. What have you done to expand NIH support for NDRI?
Answer. Approximately two-thirds of the National Disease Research
Interchange (NDRI) enterprise activity is supported by private
foundations and fees charged to for-profit corporations. The remaining
one-third of the activity is supported by an NCRR/NIH cooperative
agreement, now in its tenth year. The National Center for Research
Resources (NCRR) provided sole support during the first eight years of
the grant. Currently, four additional NIH components (the National Eye
Institute (NEI), the National Institute of Allergy and Infectious
Diseases (NIAID), the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), and the Office of Rare Diseases (ORD), also
provide co-funding for the grant.
Question. More specifically, have you met with each Institute
Director and encouraged them to work with NDRI to access its human
tissue resources to meet the special needs and initiatives of each
Institute?
Answer. A memorandum was sent to the directors of the various
Institutes in July of 1999, inviting them to participate with NCRR in
support of this endeavor. The scope of the NDRI service to the
biomedical research community has been reviewed by a committee of
experts and NCRR's National Advisory Council. The level of support
provided for NDRI reflects the recommendations of the peer review
process. The total level of NDRI funding would be the same whether NCRR
alone or NCRR along with several other NIH components supported the
NDRI award.
Question. If not, why not?
Answer. The NDRI user (investigator) list and the NIH institutes or
Centers relevant to the research areas were systematically reviewed. As
a result of that analysis, four additional NIH components were invited
to cofund the NDRI application and all four agreed to participate. The
other NIH components supported only a very small percent of the user
activity.
Question. If so, please report what next steps have been taken by
each Institute Director.
Answer. As noted above, the NEI, the NIAID, the NIDDK, and the ORD
have joined NCRR in cofunding the cooperative agreement entitled
``Human Tissue and Organ Research Resource (HTOR).''
Question. When will you begin providing NDRI with supplementary
funding through the Multi-Institute Initiative?
Answer. Cofunding by the above-mentioned Institutes and Centers is
currently in place. As noted above, the total level of funding for the
NDRI application is independent of the number of NIH components which
cofund the application. The peer review process provides
recommendations to NIH staff as to the scientifically and technically
meritorious aspects of the NDRI application and the applicant provides
estimated costs for those costs. These same principles hold for the
peer review and subsequent funding of other meritorious research or
resource grant applications. Question. How much direct supplementary
funding will NIH provide NDRI through the Multi-Institute Initiative
beginning July 1, 2001?
Answer. The Notice of Grant Award will be augmented by $300,000
from NIAID in support of the second year of the demonstration pilot
project to obtain HIV positive tissues. The increased level of support
reflects additional NDRI activity related solely to NIAID.
Question. What is your plan to secure supplementary Multi-Institute
Initiative funding for NDRI beyond June 30, 2003?
Answer. A memorandum will be sent again to the Institute Directors
inviting them to support the Human Tissue and Organ Research Resource
(HTOR) cooperative agreement.
ninds stroke strategic plan
Question. Dr. Penn, I am concerned that stroke remains a leading
cause of permanent disability and the third largest killer of men and
women in the United States. Last year this Committee encouraged the
National Institute of Neurological Disorders and Stroke, as part of
your strategic planning, to work with the research community,
clinicians, voluntary health organizations, and patient advocacy groups
to discuss new avenues of basic and clinical stroke research
opportunities. Please provide us with an update on this activity.
Answer. Stroke research is a high priority of NINDS because this
neurological disorder is the most common cause of disability, and the
opportunities for progress in both prevention and treatment of stroke
are very great. The Institute's overall strategic plan, Neuroscience at
the New Millennium, addresses research questions of importance to
stroke in its discussion of neural environment, experimental
therapeutics, funding of research in this area and clinical trials.
Evidence of the importance of stroke to our Institute's efforts,
funding of research in this area is supported in both ``Clinical
Trials'' and ``Neural Environment'' extramural program groups.
trans-agency conference on heart disease and stroke
Question. Dr. Lenfant, several years ago this Subcommittee
encouraged the National Heart, Lung, and Blood Institute to hold a
trans-agency conference on heart disease and stroke to obtain an
assessment of progress and opportunities and develop a comprehensive
research and prevention agenda on heart disease and stroke for the 21st
Century. I have heard that the report on this conference was released
in December of 2000. What was the conclusion in the report and how do
you plan to implement the findings?
Answer. The report of this conference was published in the December
19/26, 2000 issue of the journal Circulation. Among the conclusions
were that, for the United States as a whole, the coronary heart disease
(CHD) death rate is still declining, but more slowly than it did
between 1970 and 1990; stroke mortality rates have declined little
since 1990; striking differences exist in levels and trends of
cardiovascular disease (CVD) by race/ethnicity, socioeconomic status,
and geography (for example, rates of CHD death have declined more
slowly among black men than among white men); and trends in levels of
risk factors are consistent with the slowing in the decline in the
death rate (little change since 1990 in smoking prevalence, physical
inactivity, and hypertension control and striking increases in
prevalence of obesity and type 2 diabetes). The conference also
concluded that although there is considerable activity in prevention
and treatment of CVD, much more needs to be done with respect to
assessing risk factors and applying proven approaches to treat them. A
number of recommendations were made with respect to application of
current knowledge and further research.
Concerned about data presented at the conference that some
Americans are not enjoying the improvements in health that can be
realized by applying existing clinical guidelines and other medical
information, the NHLBI recently developed and implemented several new
programs. One, an education initiative, entails Enhanced Dissemination
and Utilization Centers (EDUCs) in communities with heart disease and
stroke death rates that far exceed the national average. These centers
will become the foundation of a network of Healthy People 2010
performance partners committed to eliminating of racial/ethnic and
geographic health disparities in underserved high-risk populations.
Funded centers are using information generated by the national
education programs of the NHLBI to inform their communities of the
public heath burden of CVD and are developing, implementing, and
evaluating educational strategies to reduce the burden through changes
in behavior of health care providers, patients, and the general public
related to the prevention and control of CVD. The six current centers
are located in Arkansas, North Carolina, Virginia, West Virginia (two),
and Texas. One of the EDUCs, West Virginia Health Right, Inc., in
Charleston, is a free primary care clinic that serves the uninsured and
under-insured poor. At the North Carolina EDUC, Wake Forest University
School of Medicine will collaborate with the Robeson County Partnership
for Community Health, Columbus County Hospital, and Columbus County
Healthy Carolinians to reach low-income blacks and Native Americans
with CVD screening and cardiovascular health education activities. The
University of North Texas Salud para su Corazon Outreach Initiative
EDUC is a collaboration among the University, the Dallas Concilio,
Northside Clinic, Hispanic Health Coalition of Fort Worth, and Harris
Methodist Hospital to use lay health educators to reach Hispanics with
cardiovascular health promotion and disease prevention activities.
EDUCs are one element of a larger heart-health agenda that the
NHLBI launched as part of its efforts to meet the cardiovascular health
goals and objectives in the federal government's Healthy People 2010
Report. On February 1, the NHLBI, several other federal health
agencies, and the American Heart Association (AHA) signed a Memorandum
of Understanding (MOU) to speed progress toward heart disease and
stroke goals set forth in Healthy People 2010. This historic MOU has
created a working partnership that promises to improve greatly the
nation's cardiovascular health by the year 2010. The federal agencies
and the AHA will work to accomplish four cooperative knowledge
application goals for heart disease and stroke: prevent the development
of risk factors; detect and treat risk factors; achieve early
identification and treatment, especially in the acute phases of
disease; and prevent recurrence and complications. The NHLBI also
sponsored a workshop in March as the first step in developing an
ambitious agenda for a new women's heart health education effort. It
brought together a group of about 60 key researchers, public health
leaders, women's and minority health advocates, health communicators,
health care delivery experts, patients, and others who have a stake in
improving women's cardiovascular health to develop a science-based
blueprint for a comprehensive health education effort for patients,
health professionals, and the public. Late this summer an award will be
made for program support to launch the nationwide education effort. In
addition, the NHLBI is continuing to collaborate with the National
Recreation and Park Association to develop and implement a nationwide,
community-based program to reduce the growing trend of obesity and the
risk of CHD in the U.S. by encouraging Americans of all ages to aim for
a healthy weight, follow a heart-healthy eating plan, and engage in
regular physical activity. The program targets high-risk and
underserved neighborhoods through community park and recreation
programs.
The NHLBI will continue its ongoing projects in African American
and Latino communities and is now taking steps to implement strategies
to improve the health behavior of several underserved Asian American/
Pacific Islander (AAPI) groups, including those of Philippine,
Vietnamese, Native Hawaiian, Samoan, Cambodian, Hmong, and Laotian
heritage. To begin formulating culturally and linguistically sensitive
heart health education materials for these AAPI ethnic groups, consumer
interviews and discussions with community leaders are being conducted
and efforts to build community-based networks in these underserved AAPI
communities have begun. So far, 15 community-based network partners
across the country have been enlisted to assist in the implementation
of outreach activities in underserved AAPI communities. The NHLBI is
also beginning the second phase of its three CVD projects in American
Indian and Alaska Native (AI/AN) communities to develop and implement
community-based interventions to increase awareness and to expand
adoption of heart-healthy behaviors and thereby reduce health
disparities. The three communities are the (1) Ponca Tribe of Oklahoma
with about 2,500 members, (2) Bristol Bay Area Corporation with 32
villages in Southwestern Alaska, and (3) Laguna Pueblo in New Mexico
with about 4,000 members. The NHLBI has joined forces with the Indian
Health Service to use the tools and materials developed during the
first phase of the project to implement community-based outreach and
education activities in the three communities over the next 3 years.
To continue the dialogue regarding the issues and recommendations
put forth at the CVD Trends Conference, the NHLBI is sponsoring a
National Cardiovascular Health Conference, ``Cardiovascular Health for
All-Meeting the Challenge of Healthy People 2010,'' to be held in
April, 2002 in Washington, D.C. We expect an onsite attendance of 2,000
health professionals committed to eliminating the racial/ethnic,
gender, and geographic disparities reported at the CVD Trends
Conference. Conference cosponsors include the AHA, the CDC, HCFA, and
HRSA. The Institute has also developed an innovative NHLBI Healthy
People 2010 Gateway Web site and integrated Health Information Network
(HIN) at http://hin.nhlbi.nih.gov. Visitors to the Gateway are offered
quick access to a wide range of resources that can be used for planning
and implementing community-based Healthy People (HP) 2010 activities.
The current NHLBI HP 2010 performance projects are defined, and ongoing
activities and progress of performance teams are reported through a
variety of means including Webcasts of major meetings, electronic
communication memos, and special Web pages that provide details about
performance partners, major project events, pilot project results, and
access to the latest NHLBI-developed resources. Visitors are encouraged
to complete an electronic application to become a HIN partner. Partners
receive electronic notifications of new NHLBI educational products and
services, late-breaking news of NHLBI-funded research findings,
notification of NHLBI conference Webcasts, distance learning
opportunities, and special Web-based applications such as interactive
disease mortality maps to assess the magnitude of the public health
burden of disease by state and Health Service Area. Network membership
has been increasing on a daily basis-it currently numbers over 11,000
health care providers, public health practitioners, patients, and other
interested consumers nationwide as well as a growing international
representation.
The Institute is also funding a program of grants to evaluate
interventions in clinical care settings that are designed to improve
adherence to medically prescribed lifestyle changes used to treat heart
disease. This program targets racial and ethnic minorities and/or
persons living in poverty. In addition, the NHLBI is initiating an
evaluation of innovative strategies that can be used in clinical
practice to improve implementation of evidence-based guidelines for
treatment of heart disease.
new cholesterol guidelines
Question. Dr. Lenfant, I am a staunch proponent of prevention.
Cholesterol is a major risk factor for heart disease, the leading cause
of death of Americans, and for stroke, the No. 3 killer in the United
States. The National Heart, Lung, and Blood Institute's new cholesterol
guidelines have received a lot of attention. These guidelines are the
first major revision in about 10 years. Please explain to this
Committee how these guidelines have changed from the ones published
nearly a decade ago and how well can you insure that these new
cholesterol guidelines are implemented.
Answer. The new cholesterol guidelines developed by the Institute's
National Cholesterol Education Program (NCEP) Adult Treatment Panel III
(ATP III) are evidence-based. The ATP III report states explicitly the
nature and strength of the evidence, derived from a rigorous and
systematic review, that forms the basis for its conclusions and
recommendations. Compared with the previous guidelines, which were
released in 1993, the ATP III guidelines have several new features.
First, they call for more aggressive lowering of LDL (bad) cholesterol,
the primary target of therapy, in individuals at high risk for a heart
attack or death from coronary heart disease (CHD). This high-risk group
includes those who have CHD itself, diabetes, or multiple (2 or more)
CHD risk factors and a 10-year risk for CHD greater than 20 percent.
These high-risk people have the most stringent LDL goal: <100 mg/dL.
Individuals with multiple risk factors and a 10-year CHD risk of 10-20
percent are also at substantially elevated risk and often require
aggressive therapy, but their LDL goal is somewhat less stringent: <130
mg/dL. The ATP III report provides a risk assessment tool to identify
individuals who require intensive cholesterol-lowering treatment; based
on data from the NHLBI Framingham Heart Study, it enables calculation
of 10-year CHD risk. A second new feature is a more intensive set of
Therapeutic Lifestyle Changes (TLC) that constitute the mainstay of
cholesterol-lowering therapy and offer greater potential to lower LDL
than the previous guidelines. Third, the new guidelines define and
recommend treatment for a cluster of CHD risk factors known as ``the
metabolic syndrome,'' which is related to the increasing prevalence of
obesity and overweight in the United States. Fourth, the ATP III report
urges greater clinical attention to high triglycerides and low HDL
(good) cholesterol, both of which are linked to increased risk for CHD.
Fifth, the guidelines recommend a complete lipoprotein profile (total,
LDL, and HDL cholesterol and triglycerides) as the preferred initial
test for detecting cholesterol problems. Sixth, ATP III sets a new
level at which low HDL becomes a major CHD risk factor (<40 mg/dL, as
compared with <35 mg/dL in ATP II). Seventh, ATP III recommends ways of
improving professional and patient adherence to the guidelines and to
appropriate therapy.
The new guidelines identify many people who are at higher risk for
CHD than had previously been recognized and, thus, their application
will increase the number of people who need cholesterol-lowering
lifestyle therapy from about 52 million to about 65 million. Of these,
about 36 million will need to combine drug treatment with lifestyle
changes to achieve an adequate reduction in CHD risk; the vast majority
(80 percent) of them are in the two highest categories of CHD risk.
The results of cholesterol-lowering clinical trials suggest that
full implementation of ATP III guidelines could produce approximately a
30 percent reduction in the rate of CHD, which continues to be the
leading cause of death of women and men in this country and currently
accounts for almost 500,000 deaths annually. To help ensure
implementation of the ATP III guidelines, the NCEP has developed an
array of new products and tools. For professionals, the aids include an
Executive Summary of the evidence and recommendations that was
published in the Journal of the American Medical Association (JAMA)
together with a patient page on cholesterol and an editorial from the
JAMA editors urging physicians to implement the guidelines. Other tools
include a PowerPoint slide show for teaching the guidelines to
professional audiences; an ATP III At-A-Glance Desk Reference that
outlines the basic action steps in management of LDL, HDL, and
triglycerides; a Palm OS interactive tool that puts the guidelines at
the fingertips of physicians for use at the point of care; and a 10-
year CHD risk calculator in online and downloadable (Excel spreadsheet)
versions. To empower patients to be active partners in their care, the
NCEP has developed a new patient brochure entitled ``High Blood
Cholesterol--What You Need to Know,'' a 10-year CHD risk calculator for
lay audiences, and an updated Web site (``Live Healthier, Live
Longer'') that reflects the new information in the ATP III report. All
of these tools are available on the ATP III Web page, which can be
accessed by going to the NHLBI Web site (www.nhlbi.nih.gov). In
addition to developing and distributing these new products the NHLBI,
through the NCEP, has established a strategic partnership with the
National Committee for Quality Assurance (NCQA) to promote adoption of
the new guidelines. The NCQA and the NHLBI cosponsored a national
conference for professionals on ATP III implementation June 3-5, 2001.
The HEDIS (Health-plan Employer Data and Information Set) performance
measures of the NCQA can help ensure implementation of ATP III, and
NCQA involvement will extend the reach of the new recommendations into
managed care. By these various means, the NHLBI and the NCEP are
seeking to speed adoption of the ATP III guidelines.
RETURN ON INVESTMENTS
Question. As you know I believe that NIH is the crown jewel of the
federal government and an institution that deserves our highest
priority. I am always concerned, however, about the returns we see from
our investment.
I realize that establishing deadlines in science such as predicting
when a certain disease will have a cure is difficult to do, however,
how do you propose that we measure the return we are getting from our
investment in NIH?
Answer. As required by the Departments of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act, 2001,
the NIH will be addressing the issue of return on NIH investments by
submitting a report by July 2001 that includes a listing of therapeutic
drugs which are FDA approved, have reached $500 million per year in
U.S. sales, and have received NIH funding.
POPULATION MORBIDITY AND MORTALITY RATES
Question. Do we see an improvement in morbidity and mortality rates
as a result of government funded research?
Answer. It is difficult to attribute the exact share of
improvements in population morbidity and mortality rates that is due to
government funded research. Historically, we know that health and
longevity are influenced by increases in income, education, public
sanitation and access to care. Of course NIH does not control access to
care or participate directly in the delivery to care. However, there is
much evidence from clinical trials that new research-based technologies
can reduce mortality and morbidity rates when applied appropriately.
And recent declines in population morbidity and mortality rates for
specific conditions and disorders can be attributed, at least
partially, to research-based diagnostic screens, vaccines and other
preventives and therapies.
The age-adjusted death rate for all causes fell from 577.0 per
100,000 in 1979 to 471.7 in 1998 (Use of the age-adjusted rate adjusts
for increases in deaths due to growth and aging of the population).\1\
The corresponding rate for Diseases of the Heart, the leading cause of
death, fell from 199.5, to 126.6. over the same period. The recent data
on age-adjusted decline in heart attacks and deaths due to heart
disease is based on years of research to identify and refine our
ability to control risk factors for heart disease such as hypertension
and high blood cholesterol levels. Research confirmed the effectiveness
of diet and exercise in controlling risk factors and conditions such as
high cholesterol levels, hypertension, obesity and diabetes.
Preliminary, unpublished analysis suggests that the majority of the
reduction in the Cardiovascular Disease mortality rate from 1950 to
1990 may be attributable to providing this information to the public.
Information about risk of hypertension, smoking, and high cholesterol
levels was made available and diffused widely to individuals and to
physicians throughout the country. In response, people modified their
diets and exercise patterns, and physicians changed their testing
protocols and medical advice, according to a Harvard University study.
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\1\ National Vital Statistics Reports, Vol. 48, No. 11, July 24,
2000. Table 7.
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The use of the common aspirin, to reduce the risk of heart attack
and as part of the immediate post heart-attack treatment, is another
example of an application of research which, at small expense, reduces
health care costs.
Another example comes from research on the prevention of stroke
patients who suffer from atrial fibrillation. The two million Americans
who have atrial fibrillation are six times more likely to have a stroke
than people who do not, and this accounts for as many as 80,000 strokes
a year. A decade long study, by NINDS, carefully examined the best
strategy for balancing prevention of strokes versus the risk of adverse
side effects among such individuals. Aspirin was recommended for
patients with atrial fibrillation in the low risk category and warfarin
for those with more risk factors for a stroke. This is another
significant example of careful research to provide a tailored, low-tech
strategy to prevent a high cost disease.
Another example of a low-tech alternative therapy was provided when
research, supported by NIDDK, confirmed the efficacy of a new therapy
for peptic ulcers using already available pharmaceuticals. Treatment of
the cause of these ulcers, a bacterium (Helicobacter Pylori), using a
``triple therapy'' of available drugs--tetracycline, metronidazole, and
bismuth subsalicylate (Pepto-Bismol)--speeds the cure and cuts the
recurrence rate of ulcers. Research found the recurrence rate for
peptic ulcer fell to the 12 percent to 13 percent range, compared to
the 74 percent to 95 percent recurrence rate with the previous
conventional treatment using antacid preparations and surgery. The
resulting annual savings in treatment costs are estimated in the
hundreds of millions of dollars. Cataract surgery is another example of
an intervention which extends working life and enhances functioning and
independence of the retired. Intervention to restore sight is essential
for human well-being. What once required a long hospital stay including
days in intensive care, is now performed on an outpatient basis.
Meanwhile, the National Eye Institute continues to support research
aimed at understanding and preventing cataracts, as well as other
vision disorders.
Another evidence of advance is the reduction in infant deaths from
all causes from just less than 5 per 100 live births in 1940 to less
than one per 100 today. The causes are multiple, but many are research
based. Infant mortality rates from congenital cardiovascular
malformations, for example, have declined as a result of rapid advances
in the field of infant heart surgery. Several research projects have
contributed to improved evaluation and treatment guidelines, the
development of 3-D imaging techniques, echocardiography, and deep
hyperthermia surgical technique.
HIV/AIDS remains a national and international epidemic, but there
has been research based progress in this area as well. In the U.S. the
incidence rate of new cases dropped for the first time in 1993 and
deaths among people with AIDS declined for the first time in 1996,
dropping 25 percent.\2\ As a result of new, more effective combination
therapies, people are living longer with HIV and development of
opportunistic infections are being delayed.
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\2\ MMWR. ``HIV and AIDS in the United States'' June 1, 2001/Vol.
50/No. 21. Figure 1, page 432.
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These are but a few examples of where medical research has improved
health and reduced morbidity and mortality.
NEW TECHNOLOGIES IN NIBIB
Question. I note that you are requesting $40.2 million for a new
National Institute of Biomedical Imaging and Bioengineering for
creating new technologies. Is there any thought given by yourself or
your staff about the cost-effectiveness of these new technologies?
Answer. We are excited about the new opportunities that the new
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
will create for support of fundamental research that applies principles
of engineering, mathematics, computer science and the physical sciences
to biological processes, disorders and diseases. NIBIB has great
potential to promote innovation and discovery that could have a
significant impact on virtually every area of medical science. We have
just begun to constitute our research portfolio and identify
programmatic gaps and prioritize the many scientific opportunities
before us. As the application of these scientific disciplines to
medicine is still relatively new, it would be premature to make
ironclad promises as to their cost-effectiveness. However, we plan to
conduct technology assessment and outcome studies as authorized by
legislation. As the science and the NIBIB research portfolio mature, we
will plan to conduct such evaluations to answer the question you
propose.
Question. Are we at risk of developing technology that is
unaffordable to many people as we are seeing with some of the AIDS
antiviral drugs?
Answer. NIBIB will support fundamental research that applies
principles of engineering, mathematics, computer science and the
physical sciences to biological processes, disorders and diseases. In
some respects, such an approach to human health is still relatively
new. We will support studies that examine incremental changes from
technologies as they are applied today, as well as new and innovative
approaches that reject current technologies in favor of completely new
paradigms. The studies that NIBIB will support will add to
biomedicine's knowledge base. At this juncture, there is no way to tell
which as yet undeveloped technologies may make the largest impact on
health and what the cost of these technologies would be. NIBIB's is
authorized to conduct technology assessments and outcome studies, and
such evaluations will address these key issues.
RESEARCH PROJECT GRANTS
Question. I also note that the funding rate for grant applications
has remained at around 1 in 3. Are the remaining two-thirds of
significant less quality?
Answer. Success rates for Research Project Grants (RPGs) represent
a complex set of factors. They represent the ratio of RPG awards to the
total RPG applications received for that fiscal year. Success rates
vary among Institutes, among RPG activities such as single-investigator
initiated traditional (R01s) grants and multiple investigator program
projects (P01). Success rates and submission of applications also vary
among types of grants, such as new grants, first time awardees, and
competing renewals which depend on the cycling of grants from
noncompeting to competing status. Furthermore, there is not a linear
relationship between budget level, number of applications, and number
of awards. That is, an increase of twice the current budget levels will
not result in an increase in twice the number of applications or twice
the number of grants awarded. This is because institute portfolios are
based on a number of interrelated mechanisms and factors, including the
balance between intramural and extramural research, investigator
initiated projects, contracts, centers, as well as the number of grant
applications, the size of grants, the length of project periods.
With the recent increases in the NIH budget, we have funded
research project grants that typically have larger budgets, such as
clinical trials, epidemiologic studies and various genomic projects. We
have also witnessed an increase in the number of applications, but not
to the extent that has significantly affected our success. There are
always some projects that would ordinarily remain unfunded, but which
have some particular value and for which we might make a modest award.
However, our experience is that those applications that are in the
lower half of all applications received are generally in need of
significant revision before we would consider funding.
MERITORIOUS RESEARCH
Question. Are we shutting out the majority of meritorious research
with our current budget?
Answer. No, we are not shutting out the majority of meritorious
research with the current NIH budget. While peer review remains a
highly competitive process, the NIH is firmly committed to funding
meritorious research. The Institutes and Centers (ICs) have developed
various strategies to fund applications that are of particular
significance or importance to public health, e.g., through selective
pay or bridge grants. In some cases it may be desirable to fund a
portion of an application or provide seed money to help an applicant
develop a fuller research plan for re-submission and review at a later
date.
CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAMS
Question. Are the programs in place at the NIH to attract clinical
researchers sufficient?
Answer. The NIH launched three new clinical research career
development programs in fiscal year 1999--Clinical Research Curriculum
Award (K30), Mentored Patient-Oriented Career Development Award (K23)
and Mid-Career Investigator in Patient-Oriented Research Award (K24).
These programs have been successful and continue to attract
enthusiastic response from the community. Since their inception, NIH
has funded 278 K23, 158 K24, and 55 K30 awards.
In addition to these programs, the NIH is currently developing a
program announcement to provide support to institutions to develop
degree-granting programs in clinical research. It is anticipated that
the National Center for Research Resources will take the lead in this
initiative and launch it in fiscal year 2002. We believe that these new
programs, along with the other existing clinical career development
awards, e.g., K08, K12, etc, have gone a long way in addressing the
need for training more qualified physician scientists.
Question. Are you seeing an adequate number of clinical research
grant applications in comparison to basic science?
Answer. In fiscal year 2000, the NIH funded over 11, 000 clinical
research awards out of a total of 44,363 awards (26 percent), both new
and continuing projects. This number of awards includes all types of
NIH-supported extramural awards, including training grants, fellowship
awards, construction grants, NLM resource awards, and research and
development contracts. The percentage of clinical research awards has
remained relatively stable for the last five years.
STEM CELL
Question. I asked for detailed responses from each of your
institute directors on the role of stem cells in the mission of their
respective institute. Most of these reports give overwhelming support
to the potential of stem cells in their field. I also understand that
you have only received 3 applications for stem cell grants this year.
Is this surprising to you?
Answer. Still in review. Will provide an answer upon completion.
CANAVAN'S RESEARCH
Question. Please explain to the Committee what research is
currently being conducted at the NIH on Canavan's Disease.
Answer. Canavan's disease is one of a very large number of
childhood brain diseases, each caused by inherited defects in a
different enzyme. In this case, the enzyme affected is called
aspartoacylase and the disease is very severe. About a decade ago,
scientists identified the enzyme that was at fault. About five or six
years ago, the gene causing the defect was identified. Just last year,
an NIH-funded scientist succeeded in creating a genetically engineered
mouse model of Canavan's disease. The mouse model of the disease will
enable researchers to study precisely how the gene defect harm the
brain and to develop and test possible therapies. More generally, NIH
supports considerable efforts to develop therapeutic interventions for
the many inherited enzyme disorders, such as Canavan's, for which the
gene is now known, but no therapy is available. These potential
interventions include conventional drugs, gene therapy, use of stem
cells, and enzyme replacement. NIH is encouraging more research
concerning these diseases through workshops, solicitations and other
efforts.
A recent report indicated that an application that was pending
before the NINDS was not funded because of the lack of a control group.
Question. Please provide a detailed description of the problems
involved in funding a safety trial for persons with Canavan's Disease.
Answer. As you have noted, an application to study the transfer of
the aspartoacylase gene to children with Canavan's disease is pending.
As you can well imagine, the issues and considerations involved in the
design of a clinical trial to establish the safety of a gene-based
intervention for children with Canavan's disease are extensive. Such a
study involves not only gene transfer, but gene transfer to the brain
by neurosurgical procedures in children. First, the grant application
must ensure that the preclinical and preliminary clinical data are of
sufficient strength to support proposing such a trial in children.
Then, the study design presented must thoroughly address numerous
safety and ethical issues including concerns about the establishment of
outcome measures; the use of anesthesia during diagnostic MRIs and
surgery; safety controls in production of the vector, that is, the
agent being used to transfer the genetic material; potential immune
responses to the vector; safety of administration of the vector
including the number and location of injection sites in the brain and
the rate of administration; the risks of the neurosurgery itself; the
plans for post-operative care; the adequacy of the informed consent
process; the procedures established for the monitoring and reporting of
adverse events; and the overall plan for data and safety monitoring. In
addition, the NINDS must ensure that all required reviews and approvals
for a trial of this nature have been received. These would include not
only approval of the investigational new drug (IND) application by the
Food and Drug Administration, but protocol submission to the NIH
Recombinant DNA Advisory Committee (RAC), and approvals of the research
protocol, including the informed consent and safety monitoring
processes, by the local institutional review boards (IRBs).
I can assure you that members of the NINDS staff have been working
closely and intensely with the principal investigator of the proposed
study to which you refer, so that the pending application can be given
every consideration in accordance with applicable policies and
procedures. The Institute is committed to advancing research on
Canavan's disease as well as the other childhood brain diseases caused
by enzyme deficiencies that result from inherited genetic defects.
______
Questions Submitted by Senator Ted Stevens
VARIANT VCJD THREAT
Question. As you may be aware, Senate Subcommittee on Consumer
Affairs, Foreign Commerce and Tourism held a hearing on April 4 of this
year on transmissible spongiform encephalopathies, also known as TSEs.
One type of this TSE called variant Creutzfeldt-Jakob Disease (vCJD),
has been a particular problem for our friends in Britain where 97
people have died from vCJD, presumably from the consumption of prion
infected beef. In your opinion is vCJD a threat to the United States?
Answer. We should keep proper perspective since there has not been
a case of the human disease, vCJD, in the United States, but we must
remain vigilant to ensure that we take the proper steps to make sure
that vCJD does not affect people in this country. There is strong
evidence that the distinctive biological and molecular features of the
infectious agent isolated from cattle infected with BSE, or mad cow
disease, are identical to that in the human cases of vCJD, so that
prevention of the animal disease, BSE, is important for prevention of
the human disease, vCJD. BSE has not been detected in the U.S., but it
would be unwise to assume that it can't happen here. We still don't
know for sure how BSE first arose in Britain-it might have been from
``rendered'' cattle feed containing remnants from sheep with the
related disease scrapie, or perhaps BSE arose spontaneously as the form
of CJD in humans can do. We do have sheep with scrapie in this country,
as well as other animals such as deer with a closely related disorder,
chronic wasting disease (CWD). Furthermore, most cattle are slaughtered
at an age too young to show obvious symptoms of BSE or to be detected
as infected on currently available tests, so a spontaneous case capable
of harboring and transmitting the disease could go undetected. So, the
important thing is that we must make sure that we have procedures in
place to prevent an isolated case of BSE from spreading if it does
occur.
As discussed at the hearing you noted, the U.S. Department of
Agriculture, the Food and Drug Administration (FDA) and the Centers for
Disease Control and Prevention CDC) have imposed a series of safeguards
to protect human and animal health. In Britain, it was later learned
that the spread of BSE was greatly increased because carcasses of BSE-
infected cattle were used to make animal feed (meat and bone meal),
resulting in contaminated product that was fed to other cattle. The FDA
in 1997 published a regulation to prevent this type of spread of BSE,
should BSE occur in this country. The FDA regulation prohibits the use
of most mammalian protein to make feed for cattle or other ruminant
animals. We should also keep brains and spinal cords, which are most
likely to carry the disease, out of the human food chain.
We must continue to examine whether our practices are adequate and
update these measures as new evidence or better scientific
understanding dictates. Congress has charged the General Accounting
Office to do just that, and we have briefed the GAO on TSE science and
research. NIH has played an important role since the 1950's in laying
the scientific foundation for confronting the public health and
economic threats from the group of diseases that includes CJD and BSE.
In the past year, we have increased our efforts, especially those
towards developing practical tests for early detection that are badly
needed. We will continue to work with other agencies to make sure vCJD
does not become a problem in the United States.
VCJD ON THE RISE?
Question. Have we seen the worst of this disease yet?
Answer. The unsettling truth is that we just don't know. The
British are monitoring the incidence of vCJD closely. This class of
diseases has an incubation time that can be as long as decades, so it
is too early to tell. The numbers of vCJD cases in Britain each year
from 1995 through 2000 have been 3, 10, 10, 18, 15, and 27. Three
additional cases have occurred in France and one in Ireland. Great
Britain, France, and Ireland all have BSE among cattle, unlike the
United States. The small numbers don't allow any reliable prediction of
a trend, so we don't know whether 2001 will show the incidence is still
on the rise, leveling off, or starting to decline. In this country, the
CDC monitors cases of classical CJD and conducts disease surveillance
to detect the possible ocurrence of vCJD. So far, no cases of vCJD have
been detected in this country.
ROLE OF NIH IN VCJD RESEARCH
Question. What do you perceive the role of the NIH to be in
researching and finding a cure for a disease such as vCJD that has yet
to infect a single American?
Answer. Although variant of Creutzfeldt-Jacob disease (vCJD) has
not affected a single American, the conventional form of CJD kills
about 250 to 300 Americans each year. We should not forget that if BSE
were to occur in the United States, it could potentially devastate the
cattle industry as it did in Britain. This would have major economic
consequences. We are also quite concerned about the prevalence of
related diseases such as the spontaneously occurring chronic wasting
disease (CWD) in deer and elk in the United States.
NIH has supported pioneering research on CJD and other TSEs since
the 1950's. This research that has been recognized by the award, to
U.S. scientists, of two Nobel prizes because of its significance to
science and medicine. The scientific foundation of the work supported
by NINDS has been essential for confronting the public health threat of
vCJD with appropriate safeguards and without panic.
These are unusual diseases. We would not have been able to detect
the disease, how it is transmitted, where to focus our future work, and
what precautions to take, without those years of scientific
investigation supported by NINDS before BSE and vCJD appeared. We are
actively engaged in strengthening our broad program of investigation
into these disorders, including work towards developing diagnostic
tests and treatments. Last year, we awarded major contracts focused on
developing tests capable of detecting early stages of the disease,
tests that at this point, are critical to confront the public health
and economic threats.
Finally, rare diseases often show us the way toward understanding
common diseases, and there are some intriguing suggestions this may be
so in this case, too. Many scientists, including the Nobel winners I
noted, believe that the study of CJD may offer clues to more common
neurodegenerative disorders such as Alzheimer's and Parkinson's.
VIRAL SIMILARITIES
Question. Do you see any similarities between vCJD and the West
Nile Virus or the AIDS virus?
Answer. The most significant feature shared by all three of these
viruses is that they all originated as an infection of a non-human
species and humans were, or still are, the ``accidental'' hosts.
Infections such as these are known as ``zoonosis.'' The origin of
variant Creutzfeld Jacob Disease (vCJD) is thought to be bovine
spongiform encephalopathy (BSE) or mad cow disease. The mechanism of
transmission to man is still not understood. Ironically, cows may also
be an ``accidental'' host probably acquiring the infection from sheep
infected with scrapie, another related disease.
West Nile Virus (WNV) is only spread to humans by the bite of a
female mosquito, usually Culex pipiens. Humans are considered to be
``accidental hosts'' in a cycle of transmission of WNV, that is
normally from mosquito to bird and then back to mosquito, when it feeds
on infected birds. Unfortunately, infected mosquitoes can also spread
disease to man, horses, cats and dogs.
Although HIV is now most commonly spread by sexual transmission or
contact with blood from another infected human, the origin of HIV was
likely the accidental transmission to humans of a related non-human
primate virus.
While the HIV virus, vCJD, and WNV also share certain biological
properties such as the ability to affect the brain, they are caused by
different agents, take different paths to infect man, produce different
symptoms, and differ in other important ways. The agent that causes
vCJD is believed to be a ``prion'', agent containing protein only and
without a genome. Its pathology results from a chain reaction when the
prion initiates a series of repetitive improper folding of a normal
brain protein. Classic CJD is a ``slow'' disease that may take many
years between exposure and disease and the course of the disease itself
is slow, in the range of four to five years. One of the frightening
features of the new variant vCJD is that the course of disease is more
rapid, and patients progress from first symptoms to death in about a
year.
The West Nile virus is a flavivirus. This is a family of viruses
whose genome is single-stranded RNA. Unlike vCJD, WNV causes an acute
infection in that both the incubation period and the time of
symptomatic infection are short. Most infections are mild but the
severe form of the infection, encephalitis, may occur if the virus is
able to migrate from the blood to the brain.
The genome of HIV is also RNA, but during replication it is
transformed to a double-stranded DNA copy which integrates into host
cellular DNA. HIV, like vCJD, causes a chronic infection with disease
developing long after initial exposure, although some individuals may
have mild flu-like symptoms within a few weeks of infection.
These three diseases taken together serve as reminder that we must
take a global perspective on research and public health. Each of these
diseases has its origin outside of the United States. Vector-borne
diseases, such as West Nile Virus infection, which have a complex life
cycle in nature that involves an animal host that amplifies the
infection and the mosquitoes that transmit virus, have never respected
borders, and the reality of commerce and air travel today accelerates
the spread of such diseases. With modern transportation, a person or
other carrier with an infectious disease can travel to the United
States from any part of the world, often during the incubation period
of a disease--that is after infection begins but before any symptoms
are apparent. In the future, we will certainly confront other new or
``emergent'' diseases, like AIDS HIV infection or vCJD, diseases
previously unseen or rare in the United States, like West Nile or
Hantavirus, and drug resistant forms of old diseases, like tuberculosis
and malaria. Thus, we must maintain a broad research base and a
responsive public health infrastructure so we can deal with the
unexpected. NIAID has a long-standing commitment to research directed
toward understanding, identifying, preventing and controlling emerging
and re-emerging infections (for more information see the website,
www.niaid.nih.gov/dmid/eid).
VCJD AND PRION INFECTED BEEF
Question. To your knowledge, is the consumption of prion infected
beef the only way for humans to contact vCJD?
Answer. The evidence is quite compelling that vCJD is linked to
BSE, or ``mad cow disease,'' but we are not certain exactly how people
acquired the disorder from cows. Consumption of beef, especially beef
products that contain spinal cord and brain tissue, is the most likely
route. However, the FDA has also been considering potential risks posed
by the use of drugs, dietary supplements, cosmetics, and processed
foods derived from cattle. The agent of CJD cannot be destroyed by
sterilization. Thus, while CJD cannot be transmitted from human to
human by casual contact, it can be transmitted by brain material on
contaminated surgical instruments, or by drugs derived from certain
tissues, so this presents another range of possibilities, though
probably quite limited if the number of vCJD cases remains low. There
is a theoretical possibility that CJD might be transmissible by blood
products, but there is no evidence that this has ever occurred, despite
several ongoing investigations of blood donors, and specifically, of
people who received blood or blood products from donors later diagnosed
with CJD, and hemophiliacs, who are exposed to products derived from
pooled blood from large numbers of donors. So, in short, there are
other possibilities through which vCJD might be transmitted, but
consumption of products from cattle infected with BSE seems the most
likely.
PRION RESEARCH
Question. Are you aware of any other diseases that may be better
understood as a result of research in prion diseases like vCJD?
Answer. Rare disorders often provide clues to more common diseases,
and scientists have certainly argued that this is the case for prion
diseases. In particular, prion diseases seem to involve the formation
of abnormal aggregates of proteins in the brain. Abnormal clumps of
proteins are also strongly associated with several more common
neurodegenerative diseases, including Alzheimer's, Parkinson's,
Huntington's, and the spinocerebellar ataxias. For all of these
diseases, scientists are actively studying just how the abnormal
processing of proteins leads to aggregates and how that relates to the
progression of the disease. All human brains have a normal prion
protein but we do not know what its function is nor how it becomes
abnormal and possibly can cause disease. We are beginning to learn
that, when the normal prion protein and closely related proteins are
not present, brain dysfunction occurs, and this might be an important
clue. At this point, it is too soon to speculate as to where such
research will lead.
NIH SUPPORT OF PRION RESEARCH
Question. If so, does increasing our NIH investment in prion
disease make sense to you?
Answer. We are increasing our investment in this area, especially
in critical areas like the development of diagnostic tests. The
Department has been coordinating the NIH efforts with those in the FDA
and CDC. The issues of BSE in cattle and prevention of an vCSD
infections in the U.S. are of public health significance and the need
for a useful, reproducible diagnostic test is essential. However,
scientists with specialized training in prion diseases are needed to do
productive work in this area. Much of this research requires very
expensive, high level safety containment facilities, and we are working
on enhancing that aspect as well. We must also maintain close
communication with the considerable efforts underway in Europe, so we
learn from their experience and work together toward the same ends.
______
Questions Submitted by Senator Tom Harkin
PANCREATIC CANCER
Question. Pancreatic cancer is the fourth leading cause of death
from cancer for men and women, but the amount of research funding per
mortality that's devoted to it is among the lowest of all cancers.
What's more, the NCI's Progress Review Group on Pancreatic Cancer found
that there are only about 9 principal investigators in the United
States who are focused on this terrible disease. What can be done to
increase funding for research in pancreatic cancer and to get more
scientists involved?
Answer. The NCI is committed to increased resources for pancreatic
cancer research. The aim of this increase is to catalyze implementation
of the research priorities recommended in the Pancreatic Cancer
Progress Review Group (PRG) report.
The NCI has always funded outstanding research, including research
focused on pancreatic cancer. The low level of NCI funding for
pancreatic cancer research, and the limited number of researchers
focused on this disease, largely reflects the difficulty in studying
it. For example, pancreatic cancer exhibits a diversity of biological
properties, and patients exhibit a variety of nonspecific symptoms. In
addition, as noted in the PRG Report, pancreatic cancer care is
complicated, and outcomes are nearly always disappointing.
Nevertheless, the NCI is committed to a leadership role in surmounting
these difficulties.
In response to the PRG Report, the NCI is undertaking a
comprehensive review of its initiatives, activities, and funded
projects, as they relate to the PRG's recommendations. In July, the NCI
Director and other NCI staff will meet with the PRG members to identify
gaps in the NCI research portfolio and discuss strategies for filling
them. After the conclusion of this meeting, the NCI will prepare a plan
for implementing the PRG's recommendations. This plan will include
strategies for addressing recommendations that haven't been addressed
adequately. It also will include information about ongoing NCI
activities that address the PRG's other recommendations. The NCI will
reconvene a meeting of some or all of the members of the PRG in 2-3
years to discuss and assess progress in advancing scientific knowledge
and implementing the PRG's recommendations.
In summary, the NCI will aggressively increase resources for
pancreatic cancer research, and it will address and implement the PRG's
recommendations thoroughly and comprehensively. Through these efforts,
the Institute hopes to increase the number of researchers focused on
pancreatic cancer, and more importantly, to alleviate the burden of
pancreatic cancer on U.S. citizens.
Last August, the general counsel for the Department of Health and
Human Services said federal funding could be used for research on
embryonic stem cells as long as the cells met certain NIH guidelines.
But it's unclear whether any such cells exist. The only group that is
known to be distributing stem cells in the United States is WiCell, and
their cells do not meet NIH guidelines. There's an Australian
researcher who says his cells do meet the guidelines, but this claim
has not been verified.
STEM CELL FUNDING
Question. Do you know whether there are any stem cells today that
are eligible for federal funding?
Answer. Still in review. Will provide an answer upon completion.
BIOMEDICAL RESEARCH INFRASTRUCTURE
Question. The president has requested a nearly 30 percent increase
in funding for construction of extramural NIH research facilities, for
a total of $97 million. Even that increase, however, is significantly
below what's needed to address the current backlog, let alone provide
adequate lab space for the influx of new research. A 1998 National
Science Foundation study on the status of scientific research
facilities at U.S. college and universities identified an estimated
$11.4 billion in deferred construction and renovation projects, as well
as a decrease in new construction of health research facilities across
an array of institutions. Has the NIH collected any data on the extent
of this problem?
Answer. In general, the Nation's research infrastructure has served
the biomedical community well to date, allowing the United States to
remain a world leader in biomedical science. There is some data that
suggests that the Nation's biomedical research infrastructure is fast
becoming outdated or insufficient, for example the NSF report. NIH has
not collected any data itself on the extent of the problem.
The need for modern research facilities will become increasingly
urgent in the coming years. As research becomes more complex, which in
turn, requires a multidisciplinary research team with complementary
scientific expertise there are even greater demands on the nation's
already overburdened research facilities. In addition, entirely new
types of research facilities are needed to keep pace with today's rapid
rate of change in the biomedical sciences and the need to accommodate
high through-put technologies. Many emerging disciplines and
technologies require new types of specialized facilities, such as
biocontainment laboratories for handling infectious agents or clean
rooms for producing clinical-grade gene vectors. As a result,
facilities once expected to last for two or three decades can become
technologically obsolete in less than half that time.
The Acting Director of NIH, Dr. Ruth Kirschstein, appointed a
Working Group of the Advisory Committee to the Director, NIH, to
identify some of the factors that limit the construction and renovation
of biomedical research facilities. The Working Group's primary charge
was two-fold: (1) To examine the adequacy of current funding mechanisms
for enhancing the infrastructure of research facilities in the
biomedical sciences, and (2) To propose Federal actions that might
bolster needed construction and renovation of such facilities at a
variety of institutions. The Report of the Working Group was presented
at the meeting of the Advisory Committee to the Director at the meeting
this June. Dr. Kirschstein requested that the members of the ACD
further discuss the recommendations in the Report with colleagues at
their institutions; the report may be modified as a result of that
process before the ACD accepts the Report. Question. Extramural NIH
construction is authorized at $250 million. Given the current
situation, would it make sense for the NIH to spend more than $97
million?
Answer. The fiscal year 2002 Budget provides $100 million for
extramural construction, a $22 million increase (+28 percent) over
fiscal year 2001. This funding level will enable the NIH to continue to
support infrastructure upgrades at biomedical research facilities
through the Research Facilities Construction grant program.
NCCAM SUCCESS RATE
Question. The success rate for research project grants in the
National Center for Complementary and Alternative Medicine is projected
to be just 16 percent in fiscal year 2002, compared with an NIH average
of 30 percent. Why is it so low? What can we do to bring that number
up?
Answer. Success rates for Research Project Grants (RPGs), the ratio
of RPG awards to the total number of RPG applications received for a
given fiscal year, represent a complex set of factors. Success rates
typically vary among Institutes and Centers, among RPG activities, such
as single-investigator initiated traditional grants (R01s) and
multiple-investigator program projects (P01s), and among types of
grants, such as new grants, first time awardees, and competing renewals
which depend on the cycling of grants from noncompeting to competing
status.
Furthermore, there is not a linear relationship between budget
level, number of applications, and number of awards. That is, an
increase of twice the current budget levels will not result in an
increase in twice the number of applications or twice the number of
grants awarded. This is because the NCCAM portfolio is based on a
number of interrelated mechanisms and factors, including the balance
between intramural and extramural research, investigator initiated
projects, contracts, and centers, as well as the number of grant
applications, the size of grants, and the length of project periods.
For the fiscal year 2002 President's Budget submission prepared in
early April, NCCAM estimated it would receive 220 applications in
fiscal year 2001, and 245 applications in fiscal year 2002, for an
estimated success rate of 17 percent and 16 percent respectively.
It is difficult, however, for NCCAM to predict with certainty the
number of applications it will receive. Investigator-initiated
applications reflect the state of a particular arena of science, public
health need, the maturity of a scientific field, and even the morale of
the scientific community. While the detailed outcomes of scientific
discovery cannot be predicted, the current level of enthusiasm
demonstrated by the research community is expected to continue, and the
potential of current scientific opportunities and the successes of the
past lead us to predict that NCCAM's continuing investment in all
mechanisms of research support will be easily repaid in discoveries
that will benefit the U.S. public.
Question. The President's proposed NIH budget for fiscal year 2002
calls for an increase of $2.74 billion, for a total of $23 billion. But
he also wants to double the fee for evaluation activities from 1
percent to 2 percent. Wouldn't that change effectively reduce the NIH
increase by $230 million?
Answer. As with most of the Department's other public health
agencies, NIH contributes its fair share of funds to the Public Health
Service Evaluation Fund, as authorized under Section 241 of the PHS
Act. NIH traditionally, provides about 70-75 percent of these funds,
reflecting the relative size of the NIH budget. These funds have always
been used to support health statistics surveys by CDC/NCHS, health care
services and health care quality research by AHRQ, and, as proposed for
fiscal year 2002, national data collection surveys by SAMHSA and policy
research by ASPE. NIH receives significant benefits from the projects
supported through theses funds. By financing them through the PHS
Evaluation Fund, the President's Budget proposes to more fully reflect
the cross-cutting value of these health surveys and health care
research activities of NCHS, AHRQ, SAMHSA, and ASPE. Under the fiscal
year 2002 request, NIH's evaluation fund share would increase by $189
million over its fiscal year 2001 contribution. Excluding the
evaluation fund assessments in the base, as well as in the request,
NIH's proposed budget would still increase by nearly $2.6 billion, or
+12.7 percent in fiscal year 2002.
______
Questions Submitted by Senator Ernest F. Hollings
RETINAL DEGENERATIVE DISEASES
Question. Macular degeneration is a major and growing public health
problem. Macular degeneration, Retinitis Pigmentosa and other retinal
degenerative diseases can lead to blindness. How is the National Eye
Institute responding to this challenge?
Answer. Macular degeneration belongs to a group of retinal
degenerative diseases that includes retinitis pigmentosa (RP), Usher
syndrome, Leber Congenital Amaurosis, and allied diseases. As a group,
these diseases are a major cause of blindness and therefore a priority
area of research focus for the intramural and extramural programs of
the National Eye Institute (NEI). Macular degeneration affects the part
of the retina responsible for sharp central vision. One form of the
disease, age-related macular degeneration (AMD), is the leading cause
of irreversible vision loss in the United States among persons over 65
years of age, the fastest growing segment of the US population. In
spite of the public health significance of AMD, there is no proven
treatment for most affected persons and information about its clinical
course and the factors that predispose to it is limited. NEI-supported
research on the identification of risk factors for AMD can help provide
clues about the etiology of the condition and help to develop possible
strategies for intervention. Two potentially modifiable risk factors,
smoking and hypertension, have already been associated with the most
severe form of AMD. The Age-Related Eye Disease Study (AREDS) is an
ongoing multi-center study of the clinical course of AMD to identify
additional risk factors for the development of high risk
characteristics associated with severe vision loss. Another part of
this study is investigating the effect of antioxidants and zinc on the
progression of AMD. A major clinical trial is also underway to
determine whether low intensity laser treatment can prevent the
development of advanced complications of AMD.
NEI-sponsored scientists recently reported the results of a gene
transfer study that restored sight in an animal model of the inherited
retinal degeneration--Leber Congenital Amaurosis. Continuation and
expansion of this line of research offers hope for children who are
afflicted with this blinding condition and may lead to development of
gene transfer therapy applications for other inherited retinal
degenerations. Other scientists are actively pursuing laboratory and
clinical studies on the rescue and regeneration of deteriorating
neurons; the identification of genes and neurodegenerative mechanisms
for macular degeneration, RP, and related disorders; and the use of
growth factors and transplantation, as well as gene therapy, as
potential therapeutic measures. The goals of these studies are to
increase understanding of the causes and mechanisms of cell death in
retinal degenerative diseases, and to accelerate the development of
innovative strategies to prevent, treat, and cure these diseases.
LOW VISION
Question. Also, many eye diseases leave people with severely
impaired vision. Is the NEI doing anything to help them cope with their
impairment and to improve these individuals' quality of life?
Answer. To address the special needs of those with uncorrectable
visual impairment or low vision, the NEI supports a program of research
on visual impairment and its rehabilitation. Some individuals require
simple optical or mechanical aids to perform daily functions
adequately, while others may need more specialized devices or
environmental modifications. The NEI supports research to understand
the origins of visual impairment and assist in the rehabilitation of
those who have such disabilities. The NEI supports projects aimed at
improving the methods of specifying, measuring, and categorizing loss
of visual function; devising strategies to help visually impaired
people maximize the use of their residual vision; systematically
evaluating new and existing visual aids; developing an adequate
epidemiological base to understand the causes of blindness, partial
loss of sight, and visual anomalies; and studying the optical,
electronic, and other rehabilitative needs of people with visual
impairments.
Additionally, the NEI established a Low Vision Education Program as
a part of its National Eye Health Education Program to increase
awareness of low vision and its impact on quality of life. This program
is directed toward people with low vision, their families and friends,
and the health care and service professionals who care for them. It
takes particular note of the growing population of people over age 65
and other high risk populations, including Hispanics and African
Americans who are likely to develop low vision at an earlier age. As
part of this education effort, the NEI has developed a public service
campaign and a mobile exhibit on low vision that is currently traveling
to shopping malls and centers throughout the United States. It contains
an interactive multimedia touch screen program; provides information on
low vision services and resources; and displays aids and devices that
help people with low vision, all available in Spanish as well as
English. The exhibit and touch screen program explain the causes of low
vision; offer personal accounts of people living with low vision; and
provide a self-assessment to help people determine if they or someone
they know may have low vision.
______
Questions Submitted by Senator Kay Bailey Hutchison
FUNDING COLLABORATION
Question. U.S./Israel Cancer Collaboration. I understand that the
National Cancer Institute recently funded a workshop to explore the
feasibility of a U.S.-Israel collaboration on research projects related
to cancer genetics. Please describe the intention of the NIH/NCI with
respect to pursuing and funding this collaboration.
Answer. NCI staff participated in the workshop and related meetings
in Houston last fall to discuss this topic. The NCI was impressed with
the list of areas of mutual interest for potential collaborations.
Since that meeting, the joint group has identified priorities for
such collaborations. The goal is to facilitate collaborations that
result in competitive research proposals that succeed in peer review.
Building toward this goal, NCI is working on two possible
collaborations, both of which are very preliminary at this time:
--Ovarian cancer screening study.--Researchers from the Hadassah
Medical Organization in Jerusalem have expressed interest in
collaborating in a trial of a new screening strategy for women
at high risk for ovarian cancer based in the NCI's Cancer
Genetics Network (CGN). Israeli collaborators could contribute
to this trial through partnership with M.D. Anderson Cancer
Center. A pilot study to evaluate the feasibility of this trial
is underway.
--Behavioral research.--Initial discussions between NCI staff and
representatives of Hadassah Medical Organization have
identified areas of mutual interest in research on the
implications of testing individuals and families for genetic
risk factors. NCI is inviting Israeli investigators to
participate in the CGN Behavioral Research Working Group to
develop competitive grant applications for submission in the
near future.
NCI has a strong, continuing interest in facilitating international
research collaborations to meet research objectives that would be
otherwise difficult to address using only domestic resources. One high
priority area is research on the implications for the prevention and
treatment of cancer posed by interactions between genes and
environmental exposures. The scarcity of appropriate high-risk
individuals and families who have a genetic susceptibility and the
costs associated with the necessary studies has made it clear that
national and international collaborations will be crucial to the
success of our research enterprise.
Existing studies at the Weizmann Institute of Science, Rehovot, are
aimed at understanding the mechanism of action of the p53 tumor-
suppressor gene in its normal (wild type) and mutated forms.
Inactivation of the endogenous wild-type p53 gene is associated with
more than one-half of all cases of human cancer. Studies are focusing
on the identification and characterization of genes involved in p53
regulation. Other NCI-supported projects at the Weizmann Institute
address (a) use of magnetic resonance imaging and spectroscopy as
noninvasive procedures for early evaluation of breast cancer response
to hormonal therapy and (b) investigation of molecular mechanisms
through which the ErbB-2/HER2 oncoprotein contributes to tumorigenesis
in various adenocarcinomas.
At Tel Aviv University, NCI currently supports research on the
neuroendocrine and immunologic mechanisms underlying the modulatory
effects of the estrous cycle, gonadal hormones, and gender on immune
competence and tumor development.
NCI is also supporting an epidemiologic study of ovarian cancer at
the Chaim Sheba Medical Center, Tel Hashomer, to evaluate a broad range
of potential risk factors (e.g., reproductive, hormonal, nutritional,
genetic, and occupational factors). Genetic analysis is also being
added to the study. Scientists are pursuing the possibility of
performing a study to assess the role of the BRCA1 and BRCA2 genes in
prostate cancer risk, and a study of BRCA1 and BRCA2 gene mutations in
male breast cancer is also under way. In addition, a feasibility
project is being conducted to ascertain whether ataxia-telangiectasia
is hereditary in approximately 24 candidate families and to determine
procedures for a population-based study of cancer risk in these
families.
Mutations in the BRCA1 or BRCA2 gene are thought to account for
about 90 percent of familial forms of breast cancer and ovarian cancer.
In a study involving more than 5,000 Ashkenazi Jewish volunteers from
the Washington, DC area, mutations in either BRCA1 or BRCA2 occurred in
nearly 1 in 40. Collaborators on this project included scientists from
the Chaim Sheba Medical Center in Israel.
INTERNATIONAL COLLABORATIONS BY INSTITUTES
Question. Considering the success of international cooperation on
the Human Genome Project, do you see advantages to similar
collaboration with other nations, like Israel, in other research areas,
like cancer?
Answer. The NIH participates in a broad range of international
collaborations with many of the Institutes striving to develop and
maintain a strong and diverse selection of international collaborations
and initiatives. For example:
National Cancer Institute (NCI)
NCI, in cooperation with extramural institutions and the Fogarty
International Center of the NIH, supports international health research
through bilateral agreements, grants, and contracts. NCI 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, 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. Advances in cancer
research result from NCI support and from support by other U.S. and
foreign government agencies, industries, private nonprofit institutes,
and individual philanthropists.
One way in which NCI fosters joint research between U.S. and
foreign scientists is by cosponsoring international workshops. The NCI
workshops program brings together small groups of U.S. and foreign
scientists who are at the forefront of their fields of research, to
discuss their newest research that has not yet been published.
NCI is supporting several projects that are collaborative efforts
with other countries:
--NCI supports the work of investigators at Tata Memorial Hospital,
Bombay, India, in a community-based randomized-control
evaluation of low-cost methods for early detection of common
cancers in women. Breast and cervical cancers account for about
50 percent of cancer deaths in women in India. Among the
diagnostic methods being evaluated are clinical breast
examination without mammography, self-examination, and visual
inspection of the cervix by trained female health workers. The
goal is to reduce mortality by detection and diagnosis of
breast and cervical cancer at an early stage. This trial is one
of the first of its kind to be conducted in a developing
country, and findings may be relevant to other countries and
populations with limited resources (e.g., underserved
populations in developed countries).
National Institute of Allergy and Infectious Diseases (NIAID)
NIAID supports a broad research portfolio that encompasses multiple
infectious diseases including malaria, tuberculosis and HIV/AIDS.
Because so many of these diseases occur primarily or solely outside the
United States but have the capacity to emerge as public health threats
in the U.S., NIH and NIAID have long recognized that programs promoting
international research efforts and other disease control measures in
the developing world can help to protect the health of Americans as
well as the health of people living in countries where these diseases
have long been endemic. Therefore, strengthening the research
capability of scientists in their own countries is an important focus
of NIAID efforts. One of the cores of our international programs is the
rich network of partnerships--a set of alliances for conducting
cutting-edge research, fostering good will, and transferring technical
knowledge and know-how to research institutes and hospitals in regions
of the world where tropical diseases are endemic. The alliances
encourage U.S. scientists to work in and obtain expertise on disease
issues in those regions. They also enable investigators from those
areas to collaborate on research projects on site and to visit U.S.
laboratories and attend scientific conferences and workshops to discuss
with global experts the challenges of studying and combating these
diseases.
International Centers of Excellence:
An important component of the NIAID Strategic Plan is a focus on
addressing global health disparities. In order to address the
disproportionate burden of infectious diseases on third world
countries, NIAID is in the process of setting up International Centers
of Excellence (ICERs). These research centers will be joint ventures
between NIAID's intramural and extramural divisions and host nations.
Extensive infrastructure improvements, equipment procurement and
personnel and financial resources will be crucial to the success of
these endeavors. Three sites have been identified by the NIAID:
--The Tuberculosis Research Center (TRC) in Chennai, India will be
the base for an ICER to expand research on tuberculosis,
lymphatic filariasis and HIV. Research will initially focus on
the interaction between pre-existing helminth infection and
mycobacterial infection, studies of chemotherapy of TB in HIV
infected patients and the influence of non-HIV infections on
HIV expression. Longer term goals include understanding the
interaction between allergic disease and helminth infection,
the genetics of asthma in a tropical setting, drug resistance
in both helminth infection and TB, and possible assessments of
vaccines for Plasmodium vivax, TB, HIV or group A
streptococcus.
--The Rakai District in southwestern Uganda will be a base for an
ICER to focus on HIV and STDs, including the effects on
pregnancy, fertility, infant survival, placental pathology and
mother-to-child HIV transmission.
--The Papua New Guinea Institute of Medical Research will be the site
of an ICER to conduct malaria vaccine studies. The development
and testing of asexual blood stage malaria vaccines will be the
primary focus.
HIV Networks:
MAID supports two global research networks, the HIV Vaccine Trials
Network (HVTN) and the HIV Prevention Trials Network (HPTN). The HVTN
is a network of clinical sites in the United States and abroad that is
dedicated to the development of an HIV vaccine through testing and
evaluating candidate vaccines in clinical trials. The network includes
11 sites in the United States and eight sites overseas, including sites
in Africa, Asia, South America, and the Caribbean. The HVTN's global
capacity will allow for rapid expansion as more vaccine candidates
enter the pipeline for testing and development, and for carrying out
larger scale studies of suitable vaccines.
--The HPTN evaluates the safety and efficacy of non-vaccine
prevention interventions, alone or in combination, using HIV
incidence as the primary endpoint. Because HIV is transmitted
via different routes in different populations, developing a
variety of HIV prevention strategies will have a significant
impact on reducing transmission rates and slowing the spread of
HIV worldwide. Research through the HPTN is carried out through
HIV Prevention Trials Units (HPTUs) located at nine sites in
the United States and 16 sites overseas in Africa, Asia, Europe
and South America.
--More recently, NIAID released a new grant program called the
Comprehensive International Program of Research on AIDS
(CIPRA). The goals of CIPRA are to provide long-term support to
researchers and institutes in developing countries to (1) plan
and implement a comprehensive HIV/AIDS prevention and treatment
research agenda relevant to their populations; and (2) enhance
the infrastructure necessary to conduct such research.
International Histocompatibility Working Group (IHWG):
NIAID is the primary sponsor of IHWG, a multi-national
collaboration of more than 400 laboratories in 79 countries. The
collective goal of this large group is to study the tremendous
diversity of the human leukocyte antigen (HLA) gene complex, the most
variable region of the human genome, and how this diversity affects
human health. Genes of the HLA complex control immune responses and
therefore determine an individual's resistance or susceptibility to
autoimmune and infectious diseases. The HLA gene complex contains over
220 identified genes. Each gene may be present in several different
forms (alleles), and there are over 1,000 different alleles of HLA
genes. This degree of sequence variability makes the HLA complex a
uniquely valuable tool in analyzing human diversity and measuring the
relatedness of distinct geographic, ethnic, and racial populations.
Another feature of the IHWG that will facilitate its efforts is access
to large cohorts of diverse ethnic and geographic origins. This
provides tremendous statistical power for the population-based studies
of HLA genetics in human diversity, transplantation, autoimmune
diseases, and immune responses to infectious agents.
National Institute on Deafness and Other Communication Disorders
(NIDCD)
NIDCD continues to support an international consortium with the
purpose of expediting the discovery of genes responsible for hereditary
hearing impairment. The consortium encompasses research on nonsyndromic
and syndromic forms of hereditary hearing loss, such as Waardenburg
syndrome and Usher syndrome. Scientists from countries including
Belgium, Colombia, Finland, France, Germany, Israel, Japan, Norway,
South Africa, and the United Kingdom, as well as scientists throughout
the United States, continue their efforts to map the genes responsible
for syndromic and nonsyndromic hereditary hearing impairment. Almost 60
genes have been identified for recessive and dominant nonsyndromic
hereditary hearing impairment in families from Colombia, India,
Indonesia, Israel, Lebanon, Newfoundland, Pakistan, Tunisia, and the
United States, including Puerto Rico. The collaborative efforts
fostered by the consortium have been instrumental in identifying a
large number of the genes responsible for hereditary hearing impairment
and in advancing the understanding of these disorders.
The Laboratory of Molecular Genetics established a collaboration
with the University of Toronto on a study of hereditary deafness in
Ashkenazi Jews and is actively working on the genetic mapping and
identification of a novel deafness gene in a large Ashkenazi Jewish
family. This has already resulted in one publication about the hearing
status associated with a particular allele (variant) of a known
deafness gene called connexin 26 (GJB2).
NIDCD is also collaborating with the Instituto di Genetica
Molecolare of the Consiglio Nazional delle Recerche (Institute of
Molecular Genetics, National Research Council), Alghero, Sardinia,
Italy in a study of inherited deficits in the sense of bitter taste.
This laboratory has developed a unique study population in the
Ogliastra region of Sardinia, consisting of a number of genetically
isolated villages. Such populations provide important experimental
advantages of the study of common recessive genes, such as those that
cause deficits in the sense of bitter taste in individuals of European
origin. The goal of this research is to identify the genes which cause
this deficit to better understand the molecular mechanisms involved in
the sense of bitter taste in humans.
In another collaboration between NIDCD's Laboratory of Cellular
Biology and the faculty at the Sackler School of Medicine, Tel Aviv
University, Tel Aviv, Israel an attempt is underway to determine the
pattern of expression and biological effects of Myosin VI during
development of the auditory system. Myosin VI has been shown to be
required for development of hair cells and for hearing, however the
specific effects of this protein have not been determined.
National Center for Complementary and Alternative Medicine (NCCAM)
The National Center for Complementary and Alternative Medicine, in
collaboration with Johns Hopkins University, Johns Hopkins Singapore
and the National University of Singapore, is co-sponsoring a research
symposium on traditional Chinese medicine and a workshop on clinical
methodology and grantsmanship in November 2001. The symposium will
present state of the art research in traditional Chinese medicine from
investigators in the region. The goal of the workshop is to train
potential scientific collaborators in the necessary skills to
successfully compete for National Institutes of Health grants.
Scientific data and conclusions from grantees in Southeast Asia, where
traditional medicine is widely practiced and accepted, will broaden the
knowledge base of complementary and alternative medicine interventions
while providing important information on chronic diseases such as
cancer and cardiovascular disease that can be targeted to reduce health
disparities in Asian populations in the U.S.
Fogarty International Center (FIC)
The Fogarty International Center (FIC), the international arm of
the NIH, promotes and supports international collaborations to advance
medical research in virtually every area of science on behalf of the
NIH. In addition, FIC focuses attention on the scientific opportunities
and needs of low- and middle-income countries and works to reduce
disparities in global health. Working through over 20 programs and in
partnership with other NIH components, U.S. agencies and foreign
counterparts, the FIC tackles global health challenges such as AIDS,
mental illness, tuberculosis and maternal and children's health. FIC
works through bilateral and multilateral arrangements, at times
involving formal intergovernmental discussions and agreements, and more
frequently through scientist-to-scientist exchanges. Illustrative
examples of FIC-led programs include:
Multilateral Initiative on Malaria (MIM):
Launched in 1997, the MIM brings together countries from around the
world in an effort to speed discoveries in malaria research while at
the same time building capacity in countries most affected to employ
state-of-the-art prevention and control technologies. Among its
partners are public and private science funding agencies in Great
Britain, France, Japan and Norway, as well as the World Health
Organization and the World Bank. Since 1999, FIC has served as the MIM
Secretariat, and has advanced the MIM agenda in partnership with other
NIH ICs including NIAID and NLM by: increasing malaria research
funding, increasing internet access for malaria researchers, expanding
the numbers of MIM sponsors, improving the sharing of research
resources for malaria, and establishing new opportunities for the
training of African scientists in this critical field. In addition, MIM
has just recently initiated and supported the development of new
estimates of malaria mortality, now known to be close to 3 million
deaths per year, primarily in sub-Saharan Africa and in children under
the age of five, in addition to significant disability and morbidity in
Africa, Latin America and Asia.
AIDS International Training and Research Program:
Working primarily through U.S. universities, FIC supports training
of scientists and health professionals from the developing world as
part of international collaborative research programs. This training
includes Ph.D. or Master's level degrees and is the largest program
contributing to capacity to confront the AIDS epidemic in countries
hardest hit. Graduates of this training are now the leaders in their
country, reaching senior level positions in Ministries of Health,
including the Minister of Health position. They will be essential to
the design and conduct of clinical trials to test new AIDS prevention,
vaccines, and treatment technologies and to ensure that such trials are
conducted with scientific rigor as well as in accordance with
international and local ethical norms. FIC's program, which works
closely with all relevant NIH components, has led to the development of
scientific infrastructure in countries such as Uganda and Senegal where
HIV infection rates have been reduced dramatically or held at a low
level, respectively.
Pan American Fellowship Program:
Begun with NIH counterparts in Mexico in 1995, the Pan American
Fellowship Program brings post-doctoral scientists to the NIH
laboratories in Bethesda for advanced training in a range of scientific
areas. Building on mutual strengths and interests, fellows receive
training under the mentorship of chief NIH scientists in areas such as
neurobiology, infectious disease, genetics and maternal and children's
health. Every year, fifteen to twenty trainees participate in this
program, which is sponsored on a cost-shared basis by both countries.
Based on the success of the effort with Mexico, FIC expanded the
program recently to include other Latin American countries such as
Argentina, Colombia, Chile, Costa Rica, and Uruguay, with additional
support from the Pan American Health Organization to co-sponsor from
other countries in the Latin American and Caribbean region.
National Institute of Neurological Disorders and Stroke (NINDS)
In November 2000, NINDS, on behalf of the United States, signed a
Memorandum of Understanding (MOU) with the National Institute for
Physiological Sciences at Okazaki, representing Japan. The purposes of
this cooperative program are to stimulate studies of the molecular,
cellular, and integrative mechanisms of mammalian--including human--
brain function. The MOU will establish a cooperative program that will
be open to all neuroscientists in both countries. Associated activities
may include collaborative research projects, information sharing
through workshops and seminars, short-term exchanges of scientists and
other relevant activities. We believe that new knowledge about the
brain and the nervous system gained through this agreement will
favorably impact the health of all populations.
National Institute of Dental and Craniofacial Research (NIDCR)
Genetics of Cleft Lip and Palate:
NIDCR supports a project with the World Health Organization to
serve as the umbrella organization for the development and maintenance
of a global research network in the area of craniofacial anomalies
(CFA). Such a network links U.S. and NIH-funded researchers with other
researchers, and provides access to populations in other parts of the
world for studies regarding the genetic and environmental causes of
CFA, the health care systems and treatment methodologies which lead to
the best outcomes for those children born with CFA, and ways to reduce
the incidence or prevent these birth defects.
As a result of this collaboration, significant progress has
recently been achieved in understanding the genetics of cleft lip and
palate. An NIDCR-supported research team reported the discovery of the
gene responsible for cleft lip and palate when it occurs as part of a
syndrome that also includes defects in the skin, teeth, and hands. The
gene, called PVRL1, codes for a molecule that is important for cell
adhesion. Mutations in the PVRL1 gene are responsible for a recessive
cleft lip and palate syndrome, called CLPED1, which occurs with a high
frequency among the population of Margarita Island. More recently, this
research team has found preliminary evidence that individuals carrying
one copy of the mutated gene have an increased risk for cleft lip and
palate that is not associated with the other defects of the syndrome.
These results may lead to the development of early diagnostic tools and
prevention strategies for cleft lip and palate.
National Institute Drug Abuse (NIDA)
Pandemics such as drug abuse and HIV/AIDS require that we bring the
full power of science to bear on these complex public health problems.
Toward this end, NIDA has several collaborative efforts underway with
the nations of Thailand and South Africa that will likely have
advantages to enhance both the U.S. and the participating country's
research agenda.
For example, given the extremely high rates of methamphetamine
abuse in Thailand, and as a follow-up to the Pacific Regional Research
Conference on Methamphetamine and Amphetamine-Type Stimulants, held in
November 2000 in Bangkok, Thailand, NIDA has been working with the Thai
government to determine ways to best prevent and treat addiction to
this powerful stimulant. Thailand presents some unique opportunities
for collaborative efforts. For one, the government in Thailand is very
enthusiastic and committed to focusing on its methamphetamine problem.
The population of methamphetamine abusers is also unique because of the
age and symptoms of those who are abusing. Use begins at a very early
age in Thailand, typically before the teen years. By the age of 12,
some of these children are being diagnosed with long-term psychosis.
There is much we can learn by studying this population, especially as
the drug continues to spread in our own country. Also given that there
are currently no medications available in the U.S. or elsewhere to
combat this addiction, there is a behavioral treatment model (MATRIX)
that has proven successful in the United States. This model is now
being used in Thailand to help deal with their methamphetamine
epidemic.
A second example of a collaborative research effort that will
likely directly benefit the citizens of both nations is the efforts
that NIDA has underway with South Africa. NIDA has been working with
South Africa on an informal basis for over a year, but is interested in
stimulating more formalized bi-national collaborative drug abuse
research between the United States and South Africa. South Africa has
one of the fastest growing rates of the HIV infections in the world.
Although we have learned much about preventing and treating HIV/AIDS in
the United States, very little is known about the potential for
replicating science-based prevention and treatment approaches in
settings outside of the U.S. Given the many similarities between the
two countries transmission patterns and the cultural diverse
populations of its citizenship, there is much the U.S. can learn from
South Africa as it attempts to prevent HIV/AIDS with lessons learned
from the U.S.
Finally, NIDA has also begun a collaborative research initiative
with the Dutch government that includes efforts to explore areas of
mutual interest. One important area is the growing use of MDMA, or
ecstasy, and its short and long term effects on the brain. NIDA is
hosting a workshop this fall with U.S. and Dutch researchers to review
the current science and to plan for future collaborative research
projects.
National Institute of Mental Health (NIMH)
As the world leader in research on effective behavioral strategies
to decrease and prevent the spread of AIDS, the National Institute of
Mental Health is involved in a number of international collaborative
efforts that provide the opportunity to disseminate and build upon the
knowledge gained, ease the burden of disease and prevent the
international spread of a devastating disease. NIMH is supporting the
first international trial of a U.S. tested model of community-level
HIV/STD behavioral prevention program. The NIMH Collaborative HIV/STD
Prevention Trial is a two-arm randomized, community-level trial being
conducted in six countries--China, India, Peru, Russia, Uganda, and
Zimbabwe. In addition, research collaborative agreements with the
research ministries of the governments of India and South Africa have
resulted in increasing the quality of the HIV behavioral prevention
studies and helping to develop the research capacity of these
countries.
With mental illnesses occupying such a prominent place in the
global burden produced by disease, the NIMH also supports mental health
research in over three dozen foreign countries.
National Institute of Child Health and Human Development (NICHD)
NICHD, in partnership with both other NIH Institutes and the Gates
Foundation, has developed and implemented a Global Network for Women's
and Children's Health Research. This large, international collaborative
effort is essential to addressing the leading causes of morbidity and
mortality in children and women of child-bearing age in resource-poor
settings. Through partnerships between leading U.S. researchers and
senior foreign investigators, interventions to reduce maternal and
child morbidity and mortality will be tested for efficacy with advance
planning that will permit the rapid and sustainable implementation of
interventions judged by rigorous research to be successful.
The NICHD-sponsored study, The Hyperglycemia and Adverse Pregnancy
Outcome Study is an epidemiologic investigation to clarify the
association of various levels of glucose intolerance during the third
trimester of pregnancy and the risk of adverse outcomes. This
international collaborative study will enroll 25,000 women in the U.S.,
Australia, Canada, China, Israel, the Netherlands, the Republic of
Singapore, Thailand, the United Kingdom and the West Indies. The study
is examining glucose intolerance in a large heterogeneous,
multinational ethnically diverse cohort of women in the third trimester
of gestation. This international collaboration has been carefully
planned and will generate robust data on the global incidence of
gestational diabetes that will provide definitive international
reference standards. This cooperative study makes use of state-of-the-
art laboratory and measurement techniques and, via frequent steering
committee meetings, facilitates the sharing of creative and innovative
scientific thinking from around the globe. NICHD and NIDDK are acting
jointly to support this important investigation.
The Trial to Reduce the Incidence of Type I Diabetes Mellitus in
the Genetically at Risk will test the hypothesis that a nutritional
intervention during infancy will reduce the incidence of type I
diabetes in genetically susceptible infants. This randomized,
prospective controlled clinical trial will enroll a total of 2,370
infants in the United States, Australia, Canada, Estonia, Finland,
France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Spain,
Sweden, and Switzerland. The public health implications of this
nutritional intervention will be enormous if proven successful. This
study represents a collaborative international effort involving funds
from the NICHD, other NIH Institutes, the Juvenile Diabetes Research
Foundation, the Canadian Institutes of Health Research, and the
European Foundation for the Study of Diabetes. Thus, financial
contributions from both the U.S. and abroad, innovative collaborative
scientific thought from an international group of diabetologists and
pediatricians from the nations noted above, and enrollment of a large
and diverse population will synergistically act to answer a critical
public health question.
The NICHD is developing a potentially very promising research
initiative with India. This initiative will foster joint research on
the leading causes of morbidity and mortality among women of child
bearing age and children. It also will support joint HIV/AIDS research,
particularly on the prevention of HIV transmission from mothers to
their children, and research on reproductive health and sexual
behavior. Pursuing these lines of research in India offers great
opportunities to U.S. scientists because Indian biomedical and
behavioral scientists are well trained and supported by relatively
strong scientific institutions. Also, because of the growing AIDS
epidemic in India and the prevalence of many diseases and conditions in
Indian populations of women and children, India offers unique
opportunities to study new ways to improve health in large populations.
Furthermore, the Government of India is committed to research co-
funding so U.S. Government funding can be multiplied.
NICHD also sees important opportunities for research collaboration
in Africa, which has the greatest burden of maternal and child
morbidity and mortality. Research on HIV/AIDS, infectious diseases
including sepsis, upper-respiratory diseases and nutrition-related
disorders are a few examples of areas where research in Africa holds
great potential for new discoveries. In Africa it also is most cost-
effective to mount programs on a regional basis to maximize the use of
trained investigators and to assure lessons learned are applied to the
greatest benefit. Through the Global Network for Women's and Children's
Health Research, which is co-funded by the Gates Foundation, NICHD
plans to expand joint research in Africa on critical maternal and child
health interventions specifically developed for developing countries.
This promising program is a model for public-private partnership as
well as international research collaboration.
National Institute of Environmental Health Sciences (NIEHS)
Among the many reasons for pursuing international collaborations
are that some phenomena--both tools and conditions--exist in other
countries that do not exist in the U.S. One is the availability of
information. NIEHS is initiating a collaborative cohort study with
scientists and health officials in Norway to study pregnant women and
their children; this study takes advantage of that country's system of
socialized medicine both to enroll the women (a very high percentage of
women obtain early prenatal care) and to follow them and their
children. Other studies, particularly in the field of environmental
health, cast a global net to find populations and regions with higher
exposure levels to pollutants of interest, in which the divisions
between exposed and unexposed populations are more clearly delineated
and epidemiological studies are more likely to provide clear
information of either an association or a lack of an association with
disease. For instance, most of the information we have used in the U.S.
to assess risks from mercury exposure have come from studies in the
Faroe Islands in the North Atlantic and from the Seychelles Islands off
the coast of Africa, where the people eat a great deal of fish and
their mercury exposure comes through that route.
SUCCESS RATE FOR GRANT SUBMISSIONS
Question. Mental Health/National Institute of Mental Health. Where
does the National Institute of Mental Health (NIMH) stand relative to
other NIH institutes on the rate of grants submitted and funded?
Answer. In fiscal year 2000 the average success rate (awarded
grants as a percentage of total grant applications) for research
project grants was 32 percent NIH-wide. Success rates across the 21 NIH
Institutes and Centers ranged from a high of 43 percent to a low of 18
percent. The NIMH ranked 13th from the highest with a success rate of
29 percent.
QUALITY OF SCIENCE IN GRANT SUBMISSIONS
Question. Is the relative quality of science in the grant
submissions and proposals received by NIMH rising or declining?
Answer. The striking growth and scientific development of the field
of neuroscience over the last decade has served to drive a rapid,
sustained expansion of the number of very high quality research
programs in the areas of basic and clinical neuroscience. This
expansion of excellent research programs has meant that the pool of
outstanding NIH grant applications has grown at a corresponding rate.
NIMH has ``turned the corner'' in substantially upgrading its research
portfolio and retargeting research opportunities. This has resulted in
a much larger pool for these areas of outstanding applications that are
truly significant for NIMH's mission. Similar NIMH efforts in the areas
of services and intervention research have been successful in producing
and expanding a high-quality pool of better-targeted applications.
BUDGETARY INCREASES
Question. Can NIMH efficiently spend the increases enacted by
Congress in fiscal year 2000 and fiscal year 2001 again in fiscal year
2002, i.e. will good science continue to keep pace with budgetary
increases?
Answer. Yes. The science related to the brain and to behavior is at
the frontier that now attracts the most talented investigators in the
country. With the recent budget increases, NIMH has undertaken new
initiatives in several scientific areas--basic and clinical
neuroscience, and behavioral science--that are poised for rapid
development because of technological innovation and dramatic growth in
our understanding of brain function. In addition, NIMH has targeted a
significant portion of its funding to initiatives deemed by the public
and Congress to be health emergencies including research on the use of
psychotropic medications in children, youth violence in our schools and
communities, and suicide prevention. Also of note, NIMH recently
launched several large clinical treatment trials to determine the most
effective treatments for people with some of the most disabling mental
illnesses (schizophrenia, bipolar disorder and depression). These are
areas in which unprecedented advances in our understanding have emerged
coincident with critical public health needs.
Judging from peer review ratings and programmatic relevance, the
quality of the grant applications received in response to the majority
of these initiatives has been outstanding. The fiscal year 2002 Budget
level would allow additional initiatives, determined by a selective
NIMH planning process, to come on-line expeditiously. Initiatives
recently implemented, and those planned for fiscal year 2002, are
focused on topics such as development of therapeutics, training
investigators for clinical research, and genetic/molecular neuroanatomy
of the brain. Special emphasis is being placed on severe mental
disorders, including, for example, a major new centers program for
autism research.
INFORMATION DISSEMINATION
Question. In the last decade, many new treatments and services have
been developed and proven for severe mental illnesses such as
schizophrenia. Yet most individuals with these illnesses receive less
than optimal care. What steps can the NIH/NIMH take to ensure that
improvements in treatments and therapies can be effectively
disseminated to providers and patients?
Answer. NIMH focuses on research that helps to reduce the burden of
mental disorders for the American public. The Institute's research
program aims to translate the understanding of basic biological and
genetic processes, including knowledge of mechanisms underlying
thought, emotion, and behavior, into effective treatments that reach
patients with mental illness. NIMH's new generation of ``real-world''
treatment effectiveness studies will raise the standard of care for
several major mental disorders, including schizophrenia and bipolar
disorder (manic-depressive illness), by determining the best existing
treatments in thousands of patients across the U.S. The National
Advisory Mental Health Council (NAMHC) did a study of the effects of
parity for mental health benefits which helps policymakers and the
public to have the appropriate information about the costs of providing
mental health insurance coverage.
Through its Office of Communications and Public Liaison (OCPL),
NIMH publishes and disseminates research-based information on mental
disorders and their treatment for diverse audiences including the
general public, people with mental disorders and their families, health
care providers, mental health professionals, scientists, advocates, and
the media. Materials that cover the wide range of disorders and
research areas funded by the Institute are available both in print and
on the Web. At this time, the NIMH Web site (http://www.nimh.nih.gov)
is receiving approximately 7 million hits each month; and recently it
received commendation for the quality of its information, especially on
depression.
NIMH also supports a continuing Dissemination Research Program
dedicated to improving communication of research evidence to providers,
patients, and other stakeholders. A program highlight in the latest
funding cycle is a new study evaluating a web-based information system
for families and patients dealing with schizophrenia. Furthermore,
through the Small Business Innovation Research contract program, NIMH
is reviewing proposals to develop dissemination tools for schools and
other community settings. The Institute is collaborating with the
National Association of State Mental Health Program Directors to
organize workshops in the coming months to raise the profile of
dissemination and evidence based treatment for mental health in
children. NIMH/NIH is also partnering with other HHS agencies (ASPE,
AHRQ, CDC, HRSA) in an initiative to examine dissemination and
diffusion of research findings and to focus on dissemination efforts.
In April 2001 NIMH sponsored a workshop on Implementing Evidence-Based
Practice in the Public Mental Health Sector.
CONCLUSION OF HEARINGS
Senator Specter. Thank you all very much for being here.
That concludes our hearing.
[Whereupon, at 9:55 a.m., Wednesday, May 23, the hearings
was 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 2002
----------
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 EDUCATION
Prepared Statement of the American Indian Higher Education Consortium
Mr. Chairman and Members of the Subcommittee, on behalf of this
nation's 32 Tribal Colleges and Universities, which comprise the
American Indian Higher Education Consortium (AIHEC), we thank you for
the opportunity to share our fiscal year 2002 funding requests for
programs within the Department of Education.
This statement will cover two areas (a) background on the tribal
colleges, and (b) justifications for our funding requests.
BACKGROUND ON TRIBAL COLLEGES
The Tribal College Movement was launched in 1968 with the
establishment of Navajo Community College, now Dine College, in Tsaile,
Arizona. A succession of tribal colleges soon followed, primarily in
the Northern Plains region. In 1972, the first six tribally controlled
colleges established AIHEC to provide a support network for member
institutions. Today, AIHEC represents 32 Tribal Colleges and
Universities in 12 states and one in Canada, created specifically to
serve the higher education needs of American Indian students.
Collectively, they serve 25,000 students from over 250 federally
recognized tribes.
Tribal colleges offer primarily 2-year degrees, although in recent
years some institutions have begun to offer baccalaureate and graduate-
level degrees. The vast majority of the tribal colleges are fully
accredited by independent, regional accreditation agencies.\1\ In
addition to college level programming, tribal colleges provide much
needed high school completion (GED), basic remediation, job training,
college preparatory courses, and adult education. Tribal colleges
fulfill additional roles within their respective communities
functioning as community centers, libraries, tribal archives, career
and business centers, economic development centers, public-meeting
places, and child care centers. An underlying goal of tribal colleges
is to improve the lives of students through higher education and to
move American Indians toward self-sufficiency.
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\1\ The Tribal Colleges and Universities are accredited by regional
accreditation agencies and must undergo stringent performance review on
a periodic basis. The higher education division of the respective
regional accreditation agency accredits twenty-seven of the TCUs. Two
new TCUs are at the Pre-candidate stage as they complete work to attain
Candidate status; one TCU is at Candidate status. Two TCUs are
accredited as ``Vocational/Adult Schools by the ``schools'' division of
the respective regional accreditation agency.
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Tribal colleges provide needed access to higher education for
American Indians and others living in mostly remote, economically
depressed areas of the country. These institutions are chartered by
their respective tribal governments and were established in response to
the recognition by tribal leaders that local, culturally-based
education institutions are best suited to help American Indians succeed
in higher education. Tribal colleges combine traditional teachings with
conventional postsecondary courses and curricula. They have devised
innovative means to address the needs of tribal populations in
economically depressed regions and are successful in overcoming long-
standing barriers to Indian higher education. Since the first tribal
college was established on the Navajo reservation, these vital
institutions have come to represent the most significant development in
the history of American Indian higher education, providing access to
under-represented students and promoting achievement among students who
may otherwise never have known post-secondary education success.
Funding of tribal colleges is grossly inadequate. While these
institutions have successfully negotiated many challenges in the
history of the Tribal College Movement, adequate funding remains the
most significant barrier to their ongoing success. Core operational
funding for 25 tribal colleges is provided through the Tribally-
Controlled College or University Assistance Act (TCCUAA), Public Law
95-471. Funding was first appropriated through the Act in 1981, and is
still less than two-thirds of its Congressionally authorized level of
$6,000 per full-time Indian student. In fiscal year 2001, the Colleges
received $3,849 per full-time Indian student. Moreover, this amount is
less than two-thirds of the estimated $6,089 per full-time student
received by mainstream community colleges. While mainstream
institutions have a foundation of stable state support, tribal colleges
must rely on the Federal government for operational funding. Because
tribal colleges are located on federal trust territories, states have
no obligation to fund them. In fact, most states do not even fund our
colleges for the non-Indian state-resident students who account for
approximately 20 percent of our enrollments.
Since their inception, tribal colleges have achieved exceptional
growth and success, yet they are the most poorly funded higher
education institutions in America. Although conditions at some have
improved substantially, many colleges still operate in trailers; cast-
off buildings; and facilities with crumbling foundations, faulty
wiring, and leaking roofs. Sustaining quality academic programs is a
challenge without a reliable source of facilities maintenance and
construction funds.
Today, one in five American Indians live on reservations. As a
result of 200 years of Federal Indian policy--including policies of
termination, assimilation and relocation--many reservation residents
live in abject poverty comparable to poverty found in Third World
nations. Through the efforts of tribal colleges, American Indian
communities receive services they need to reestablish themselves as
responsible, productive, and self-reliant citizens.
JUSTIFICATIONS
Higher Education Act requests.--The Higher Education Act Amendments
of 1998 created a separate section within Title III, Part A,
specifically for the nation's tribal colleges (Section 316). The Aid
for Institutional Development programs, commonly known as the Title III
programs, support minority institutions and other institutions that
enroll large proportions of financially disadvantaged students and have
low per-student expenditures. Tribal colleges clearly fit this
definition. Tribal colleges are among the most poorly funded
institutions in America, yet they serve some of the most impoverished
areas of the country. They fulfill a vital role of providing access to
quality higher education programs, which are specifically designed to
focus on the critical, unmet needs of their American Indian students
and communities. This funding will help the tribal colleges effectively
prepare their students for the workforce of the 21st Century in a safe
environment. The President's budget recommendation included increases
for the Historically Black Colleges and Universities programs, and the
Hispanic Serving Institutions line item under this program, while the
tribal colleges' account was level funded. We strongly urge the
Subcommittee to correct this oversight and fund this section--which is
critical to the tribal colleges--at $25 million. We ask that $10
million of these funds be specifically designated for the competitive
facilities and infrastructure improvement program created in fiscal
year 2001, also administered under this section.
The importance of Pell grants to our students cannot be overstated.
Department of Education figures show that at least half of all Tribal
College students receive Pell grants, primarily because student income
levels are so low and our students have less access to other sources of
aid than students at mainstream institutions. Within the Tribal College
system, Pell grants are doing exactly what they were intended to do--
they are serving the needs of the lowest income students by helping
people gain access to higher education and become active, productive
members of the workforce. We urge you to build upon increase
recommended in the President's fiscal year 2002 budget.
Perkins Vocational Education Act.--Section 117 (addressing
Tribally-Controlled Postsecondary Vocational Institutions) of the Carl
D. Perkins Vocational and Applied Technology Education Act provides
core funding for two of our member institutions: United Tribes
Technical College in Bismarck, North Dakota, and Crownpoint Institute
of Technology in Crownpoint, New Mexico. We support the $5.6 million
included in the President's budget request for the Tribally-Controlled
Postsecondary Vocational Institutions under Section 117. We request
report language reaffirming that this funding remain specific to these
two Tribally Controlled Postsecondary Vocational Institutions.
Greater Support of Indian Education Programs Under ESEA
American Indian Adult and Basic Education.--This section supports
adult education programs for American Indians that are offered by
tribal colleges, state and local education agencies, Indian tribes,
institutions, and agencies. Unfortunately, the section has not been
funded since fiscal year 1995. The Tribal College Act does not include
funding for remediation and adult basic education, as it only supports
those students enrolled in postsecondary programs. Yet, the tribal
colleges must continue to provide basic adult education classes for
their communities. Before many individuals can even begin the course
work needed to learn a productive skill, they first must earn a GED or,
in some cases, learn to read. According to a 1995 survey conducted by
the Carnegie Foundation for the Advancement of Teaching, 20 percent of
the participating students had completed a tribal college GED program
before beginning formal classes at the tribal college. At some schools,
the percentage is even higher. Lac Courte Oreilles Ojibwa Community
College in Hayward, Wisconsin, for example, reports that nearly one-
third of its students had earned a GED through its tutoring and testing
center. Clearly, the need for basic educational programs is tremendous,
and tribal colleges need funding to support these crucial activities.
Tribal colleges need a minimum of $5 million to meet the ever-
increasing demand for basic adult education services. Without this
minimum commitment, vitally needed services for our adult student
population cannot be sustained, much less increased to address the full
need. It is our hope that Congress will rectify this serious oversight
in fiscal year 2002.
American Indian Teacher Corps.--American Indians are severely
under-represented in the teaching ranks nationally. This program, aimed
at producing 1,000 new teachers for schools serving American Indian
students, would provide for fellowships to college students majoring in
education programs and for professional development programs in Indian
Country to support current teachers. We believe that the tribal
colleges are the ideal catalysts for this initiative because of our
current work in this area and the existing articulation agreements
tribal colleges hold with 4-year higher education institutions. We
request Congress continue to support this $10 million program, included
in the President's fiscal year 2002 budget request, to increase the
number of qualified American Indian teachers in Indian Country.
American Indian Administrator Corps.--In fiscal year 2001, a new
program was funded to establish the American Indian Administrator
Corps. Like teachers, American Indian school administrators are
severely under-represented in the profession nationally. This program
will support the recruitment, training, and in-service professional
development of 500 American Indians and Alaska Natives to become
effective school administrators in schools with large Native American
populations. We request Congress continue to support this $5 million
program, included in the President's fiscal year 2002 budget request,
to increase the number of American Indian school Administrators in
Indian Country.
CONCLUSION
Fulfillment of AIHEC's fiscal year 2002 request will strengthen the
mission of the Tribal Colleges and Universities, and contribute to the
enormous, positive impact they have on their respective communities.
Moreover, it will help ensure that American Indians will be properly
educated and prepared for the workforce of the 21st Century. As the
1997 Carnegie Report on tribal colleges stated:
``Now, as strongly as ever, we repeat our conviction that tribal
colleges deserve continued support. Their value has been proven, but
their vision is not yet fulfilled.'' \2\
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\2\ Paul Boyer, Native American Colleges: Progress and Prospects.
Princeton, NJ: Carnegie Foundation for the Advancement of Teaching,
1997.
Tribal colleges have been extremely responsible with the Federal
support they have received over the last 20 years, and have proven
themselves to be a sound federal investment.
Thank you again for this opportunity to present our funding
requests before this Subcommittee. We respectfully ask the Members of
this Subcommittee for their continued support and full consideration of
our fiscal year 2002 appropriations request.
______
Prepared Statement of the American Museum of Natural History
ABOUT THE AMERICAN MUSEUM OF NATURAL HISTORY
The American Museum of Natural History [AMNH] is one of the
nation's preeminent institutions for scientific research and public
education. Since its founding in 1869, the Museum has pursued its
mission to ``discover, interpret, and disseminate--through scientific
research and education--knowledge about human cultures, the natural
world, and the universe.'' It is renowned for its exhibitions and
collections of more than 32 million specimens and cultural artifacts.
With nearly five million annual visitors--approximately half of them
children--its audience is one of the largest, fastest growing, and most
diverse of any museum in the country. Museum scientists conduct
groundbreaking research in fields ranging from all branches of zoology,
comparative genomics, and paleontology to earth, space, and
environmental sciences and biodiversity conservation. Their work forms
the basis for all the Museum's activities that seek to explain complex
issues and help people to understand the events and processes that
created and continue to shape the Earth, life and civilization on this
planet, and the universe beyond.
Today more than 200 Museum scientists with internationally
recognized expertise, led by 47 curators, conduct laboratory and
collections--based research programs as well as fieldwork and training.
Scientists in five divisions (Anthropology; Earth, Planetary, and Space
Sciences; Invertebrate Zoology; Paleontology; and Vertebrate Zoology)
are 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, supports
doctoral and postdoctoral scientists with highly competitive research
fellowships, and offers talented undergraduates an opportunity to work
with Museum scientists.
The AMNH collections of some 32 million natural specimens and
cultural artifacts are a major scientific resource, providing the
foundation for the Museum's interrelated research, education, and
exhibition missions. They often include endangered and extinct species
as well as many of the only known ``type specimens,'' or examples of
species by which all other finds are compared. Within the 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 and documented examples of species and artifacts, providing
an irreplaceable record of life on earth. They provide vital data for
Museum scientists as well as more than 250 national and international
visiting scientists each year.
In the exhibition halls AMNH scientific knowledge and discovery are
translated into three dimensions. One of the most exciting chapters in
the Museum's history culminated just over 1 year ago with the opening
of the Rose Center for Earth and Space in February 2000. Greeted with
critical and popular acclaim and record-setting attendance surpassing
all projections, the Rose Center includes a rebuilt Hayden Planetarium,
Hall of the Universe, and Hall of Planet Earth. It leads to the Hall of
Biodiversity, which reveals the variety of Earth's living things and
expands the Museum's efforts to alert the public to the critical role
biodiversity plays in sustaining life as we know it. Together, the new
planetarium and halls provide visitors with 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 Education Department builds on the Museum's unique research,
collections, and exhibition resources to offer rich 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. Each year hundreds of thousands of
students, teachers, and schools participate in workshops, courses for
college credit, and Museum visits; more than 500,000 students and
teachers come on school visits, prepared and supported by curriculum
resources and workshops. The Museum is also reaching beyond its walls:
through its National Center for Science Literacy, Education, and
Technology, launched in 1997 in partnership with NASA, it is exploiting
new technologies to bring learning and discovery, materials, and
programs into homes, schools, museums, and community organizations
around the nation.
support for department of health and human services mission and goals
The American Museum shares with DHHS and HRSA a fundamental
commitment to improving the nation's health and advancing the research,
training, and facilities that support it. The Museum seeks a
partnership with the agency to leverage our complementary resources and
mutually strengthen our abilities to advance shared goals.
Genomic Science
DHHS is a leader in health-related research and genome science,
advanced sequencing technologies, instrumentation, and facilities. The
American Museum, in turn, is home to a preeminent molecular research
effort. Indeed, natural history and genomic science are intricately
related. The AMNH molecular systematics program is at the forefront of
comparative genomics and the analysis of DNA sequences for evolutionary
research. In its molecular laboratories, in operation now for 10 years,
more than 40 researchers in molecular systematics, conservation
genetics, and developmental biology conduct genetic research on a
variety of study organisms.
The Museum is also expanding its collection techniques to include
the preservation of biological tissues and molecular libraries in a
super-cold storage facility for current and future genetic study. This
collection is an invaluable resource for worldwide research in fields
including genetics, comparative genomics, and medicine. Such a tissue
collection will preserve genetic material and gene products from rare
and endangered organisms that may become extinct before science fully
exploits their potential. With nearly 40,000 samples already collected,
it will be the largest super-cold tissue collection in the world and
will increase the possibilities for DNA research exponentially.
Parallel Cluster Computing
Parallel computing is an essential enabling technology for
phylogenetic (evolutionary) analysis and intensive, efficient sampling
of a wide array of study organisms. A 256-processor cluster recently
constructed in-house by Museum scientists is the fastest parallel
computing cluster in an evolutionary biology laboratory and one of the
fastest installed in a non-defense environment. It allows Museum
scientists to examine the effectiveness and computational behavior for
large real-world data sets, and will be central to all Museum projects
in evolutionary and genomics research.
INSTITUTE OF COMPARATIVE GENOMICS
The Museum proposes to establish, in partnership with DHHS, an
Institute of Comparative Genomics so as to contribute its unique
resources and expertise to the nation's genomic research enterprise. A
full understanding of the impact of the knowledge we have gained from
genomics and molecular biology can come from placing genomic data in a
natural history perspective; comparative work in genomics will enrich
our knowledge not only of biodiversity, but also of humans, medicine,
and life itself. The Museum intends to establish the Institute with
funds from federal as well as nonfederal sources.
With the advent of DNA sequencing, museum collections have become
critical baseline resources for the assessment of the genetic diversity
of natural populations. Genomes, especially those of the simplest
organisms, provide a window into the fundamental mechanics of life. One
of the goals of the nation's genomic science research programs is to
learn about the relevance to humans of nonhuman organisms' DNA
sequences. This research can yield information that can be applied in
solving critical challenges in health care. The AMNH comparative
genomics program could provide vital tools in these endeavors.
The Museum has already established its parallel computing facility,
enhanced the molecular labs with state-of-the-art DNA sequencers, and
built the super cold storage facility. Thus initially equipped, the
Institute will be one of the world's premier research facilities for
mapping the genome across a comprehensive spectrum of life forms,
drawing on comparative methods and biological collections.
Working cooperatively with New York's outstanding biomedical
research and educational institutions, the Institute will focus on
molecular and microbial systematics, expanding our understanding of the
evolution of life on earth through analysis of the genomes of selected
microbes and other non-human organisms, and constructing large genomic
databases for conservation biology applications. Research programs may
include the study of the utility of genomic information on organismal
form and function, microbial systematics, the construction of large
genomic databases for conservation biology applications, and the use of
broad scale comparative genomic studies to understand the function of
important biomolecules.
The Institute's scope of activities will include: an expansion of
the molecular laboratory program that now trains dozens of graduate
students every year; the utilization of the latest sequencing
technologies; employment of parallel computing applications that allow
scientists to examine the effectiveness and computational behavior of
large real world datasets; and operation of the frozen tissue
collection as a worldwide scientific resource, with at least 500,000
samples accessioned in the first phase alone, an active loan program,
and ready public on-line access.
In addition to research, the Museum has already launched an
ambitious agenda of genomics-related exhibition, conference, and public
education programming, including the landmark exhibition, ``The Genomic
Revolution,'' which opens in May 2001. The exhibition, the most
comprehensive ever presented on genomics, will examine the revolution
taking place in molecular biology and its impact on modern science and
technology, natural history, biodiversity, and our everyday lives. In
conjunction with the exhibition, the Museum may also display a video
bulletin on genomics in the Hall of Human Biology. The bulletin would
be modeled after the popular Earth, Bio, and AstroBulletins in the
newest exhibit halls that display changing science news and link to
computer kiosks and websites.
In fall 2000 the Museum hosted ``Sequencing the Human Genome: New
Frontiers in Science and Technology,'' an international conference
featuring leading scientists and policymakers. Spring conferences will
include: ``Conservation Genetics in the Age of Genomics,'' co-sponsored
by AMNH's Center for Biodiversity and Conservation and the Wildlife
Conservation Society; and ``New Directions in Supercomputing,'' which
will explore how parallel computing can make sense of the huge complex
data sets that genomic science and other fields generate. In September,
the Museum will convene ``Assembling the Tree of Life: Science,
Relevance, and Challenges.''
In establishing the Institute, the Museum plans to expand its
curatorial range in microbial work; grow the super-cold tissue
collection; and draw on our exhibition and educational expertise to
offer enhanced public education and outreach. Plans entail expanding
and renovating lab space and facilities to accommodate additional
curators and students. By renovating an area adjacent to one of the
existing molecular labs and possibly building new space, the Museum
will add lab and associated office and maintenance space to accommodate
the new Institute's needs.
We seek $5 million in fiscal year 2002 to partner with DHHS/HRSA in
establishing the Institute for Comparative Genomics at the Museum. In
partnership, the two organizations will be positioned to leverage their
unparalleled resources to advance shared goals for improving the
nation's health through research and facilities, education and
training.
______
Prepared Statement of the Bushnell Center for the Performing Arts
Mr. Chairman of Members of the Subcommittee, my name is Ronna
Reynolds, and I am the Interim Executive Director of The Bushnell
Center for the Performing Arts, located in Hartford, Connecticut. I am
pleased to have this opportunity to share with you the exciting and
successful arts-in-education programs being conducted at The Bushnell
and to urge your support for funding for additional educational
programs in fiscal year 2002.
The Horace Bushnell Memorial Hall is an historic and nationally
recognized performing arts center. After a $34 million renovation and
expansion project, the 71-year-old Hall has been renamed ``The Bushnell
Center for the Performing Arts.'' We believe it's an appropriate name
to describe a center for the arts, a center for the community, and a
center for education that will all come together--and bring people
together--at The Bushnell.
The new Bushnell is more than just a building. It is a facility
that will enhance Hartford's position as a premier performing arts
destination. The 90,000 square-foot facility being built adjacent to
the current Mortensen Hall will include the Belding Theater, a Great
Hall for receptions and smaller performances, and such amenities as a
cafe, gift shop, classroom space and more rest rooms and elevators.
With the current Hall booked to capacity, the expansion will enable The
Bushnell to present new arts and entertainment options and better
accommodate local arts organizations in multiple performance spaces. It
will also give an economic boost by bringing more people to downtown
Hartford.
The new Bushnell facility presents the opportunity to link the
Hall's artistic programming to education and learning. For most of the
20th Century, education and serving the community has been the central
focus for The Bushnell as it has dedicated considerable resources and
leadership to create powerful tools for learning and building
community. Our educational programs serve as the stable and sustainable
base from which The Bushnell can continue to expand and deepen its
education, community service and programming. The result is a
performing arts center which serves as a classroom without walls; a
stage ``in and of'' the community.
The strongest and most visible manifestation of this commitment can
be found in the The Bushnell's arts education programs. The Bushnell
Center for Learning is the organization-wide structure through which
The Bushnell will promote and cause the arts to advance education in
communities and schools through direct services, training, advocacy,
and convening. This new Center represents a coalescing of all
educational activities of The Bushnell under one umbrella. With a focus
on direct services through classroom programs, teacher and artist
training, public policy and advocacy and community and educational
convener, The Bushnell Center for Learning places educational
programming as central to the organization's day-to-day activities.
Several programs comprise The Bushnell Center for Learning,
including direct services and programs for grade school and high school
students, as well as training programs and teaching seminars. The
Bushnell has over ten years of experience operating arts-in-education
programs that use the arts to improve literacy and to increase the
understanding of diverse cultures for over 6,000 public school students
in four school districts in Connecticut.
THE PARTNERS PROGRAM
PARTNERS (Partners in Arts and Education Revitalizing Schools) is a
nationally recognized arts-in-education program that strengthens
language arts skills and fosters multi-cultural competence in the
Hartford area schools. Implemented in 1993 in eight schools in
Hartford, West Hartford and Bloomfield, PARTNERS uses the visual and
performing arts to spark learning and generate excitement in the
classroom. Participating in the program provides not only a foundation
for artistic literacy, but more importantly, it strengthens the core
educational curriculum while bringing together a great diversity of
students in a unique educational experience. Since 1996, PARTNERS has
been active in the Plainville Community Schools in partnership with GE
Fund of Fairfield and GE Industrial Systems of Plainville.
The PARTNERS program is made up of five interlocking components:
curriculum and assessment, artistic resources, staff development, The
Bushnell Children's Theatre and family events. Curriculum and
assessment are at the core of all PARTNERS program components.
Curriculum resources ensure that cross-cultural, hands-on arts
experiences are integrated into a child's classroom experience through
multi-cultural children's literature, book-based activity guides, and
other pertinent materials. Program assessment has been carried out each
year in an attempt to review and test program components and the goals
set forth in the initial program design.
In the PARTNERS program, professional artists take on the role of
teaching artists who develop and lead classroom-based arts activities.
Presenting artists who conduct grade level assembly presentation
further students' understanding of these areas through performances
delivered at the school site. Classroom and performance experiences are
also enriched by museum, theatre, and science center field trips
throughout the year. Through the professional development component,
PARTNERS provides participating classroom, art and music teachers with
exposure and hands-on access to the arts-integrated units of study.
These sessions, held at The Bushnell, offer educators the opportunity
to use the arts as tools to enhance the learning process for their
students.
OTHER EDUCATIONAL PROGRAMS
In addition to the PARTNERS program, The Bushnell offers other
educational programs and services, including:
--Professional development and support services to educators,
artists, contributors, and organizations;
--Replication and dissemination of the PARTNERS technique and
curriculum through building the capacities of institutions,
communities and schools; and
--Integration of programming and education through a collaborative
planning process and marketing strategy to be known as ``Great
Works''.
These combined activities enrich the lives of students who are
involved in the many different Bushnell educational programs,
including:
--Living Laboratories in Schools
--Parent Enpowerment through Early Literacy and Read Aloud
--The Bushnell Children's Theatre
--Pre and post performance lectures
--Arts camps
--High School lecture series
--Teachers institutes and seminars and other professional development
programs
--Artist training
Mr. Chairman, in order to support the expansion of arts-in-
education programs at The Bushnell Center for Learning, we respectfully
request $1 million through the Department of Education's Fund for the
Improvement of Education (FIE) account in the Fiscal 2002 Labor/HHS/
Education Appropriations bill. Thank you for your attention to this
request, and for your support of programs which benefit the children of
Connecticut and children across the nation.
______
Prepared Statement of the American Council on Education Coalition for
International Education
Mr. Chairman and Members of the Subcommittee: We are pleased to
have the opportunity to present the views of the Coalition for
International Education on the fiscal year 2002 appropriations for the
Higher Education Act, Title VI and the Mutual Educational and Cultural
Exchange Act, Section 102(b)(6), commonly known as Fulbright-Hays. The
Coalition for International Education is an ad hoc group of 28 national
higher education organizations with principal focus on the
aforementioned international education, foreign language and exchange
programs. Together they represent the nation's 3,300 colleges and
universities, and numerous disciplinary, international exchange groups
and other international education organizations.
Over the history of Title VI and Fulbright-Hays, many different
groups have come to the Federal Government to make their case for these
programs. This usually has taken the form of small coalitions or
separate voices arguing for their particular interests. However, the
sense of urgency about the United States' declining international
competence against a backdrop of enormous international challenges is
so strong within the higher education community, that it has drawn our
different perspectives into a single consensus position.
We express our appreciation for the Subcommittee's support for
these programs. Title VI has grown over the last decade, and Fulbright-
Hays in the last year.
To address new and expanding challenges to the nation's leadership
capabilities in foreign policy, national security, economic
competitiveness, and solving global problems, the Coalition recommends
a 3-year strategic plan for Title VI and Fulbright-Hays. The plan
proposes increasing the number of experts with in-depth international
knowledge and highly proficient foreign language skills, as well as the
number of U.S. citizens with global competence. Our proposed funding
levels for fiscal year 2002, more fully described below, would be the
first installment of this plan.
PROGRAM OVERVIEW
At the height of the Cold War, Congress created Title VI in the
National Defense Education Act of 1958, and Section 102 (b)(6) of the
Mutual Educational and Cultural Exchange Act of 1961 out of a sense of
crisis about U.S. ignorance of other countries and cultures. Spanning
more than four decades, these programs still remain the Federal
Government's most comprehensive mechanisms for supporting the
development and maintenance of a higher education infrastructure that
produces the nation's expertise in foreign languages, and area and
other international studies, including international business. The
programs have grown and evolved over this time in response to the
changing global environment. The fourteen funded Title VI and
Fulbright-Hays programs support activities to improve our educational
capabilities, from K-12 through the graduate levels and advanced
research, with emphasis on the less commonly-taught languages and areas
of the world. Title VI largely supports the domestic side of training
and research, while Fulbright-Hays supports an essential overseas
component.
FEDERAL ROLE
The Federal Government plays a critical role in international and
foreign language education because of the clear relevance of
international competence to the conduct of U.S. foreign policy, to the
national security of the U.S., and to the health and vitality of the
U.S. economy in a global marketplace. Informed decisions in these areas
by public and private sectors depend on citizens who have the skills
and understanding of other nations' languages, cultures and systems to
function effectively within them. U.S. global leadership depends on
persons who know how the people of other cultures think and work and
who can competently assess the political, economic, or social
implications of decisions and actions. In short, it is a critical
federal role to ensure the nation is successfully prepared to respond
to the challenges presented by its relationships with other nations.
Through Title VI and Fulbright-Hays programs, the Federal
Government shares this responsibility with institutions of higher
education, in partnership with the corporate and state/local government
sectors. State and local governments and the private sector, including
foundations, will not by themselves focus on long-term national needs
for international expertise. While these sectors support short-term
projects from time to time, they do not provide the long-term,
sustained support for the 10-12 years of study and research needed to
produce an expert on the Middle East fluent in Arabic, for example.
Moreover, universities could not bear this responsibility alone.
Outside resources are essential incentives for developing and
sustaining interdisciplinary programs, underwriting high cost programs
in the less common-taught languages and areas, and providing extensive
outreach and collaboration among education institutions, government
agencies, and corporations.
EXPANDING NATIONAL NEEDS
There is fresh evidence that the nation's needs for international
competence continue to expand in the global era, and that the
government, corporate and education sectors face a dangerously short
supply of qualified personnel.
Responding to new demands to protect national security in a broad
range of arenas throughout the U.S. and the world, virtually every
federal agency now is engaged globally. One estimate is that over 80
federal agencies and offices rely on human resources with foreign
language proficiency and international knowledge and experience.
Hearings last fall of the Senate Subcommittee on International
Security, Proliferation, and Federal Services revealed the shortage of
personnel with the foreign language and area skills required to meet
national security needs across the defense, intelligence, and foreign
policy agencies. These agencies report shortfalls in hiring, deficits
in readiness, and adverse impacts on operations. One federal agency
estimated its total needs to be 30,000 employees dealing with over 80
languages, while another identified key shortfalls in Central Eurasian,
East Asian, and Middle Eastern languages.
Title VI and Fulbright-Hays are among the few programs the Federal
Government supports that provide the necessary long-term investment in
building the language and foreign area capacity that responds to
national strategic requirements. Regional expertise and language
ability related to less commonly-taught areas are offered primarily
through higher education institutions receiving Title VI funding. In
fact, a recent study funded by the U.S. Department of Education
revealed that 81 percent of the graduate language enrollments in the
least commonly taught languages are located at Title VI-funded
institutions. Because of the high cost per student, these programs
would not exist without Title VI support.
National security is increasingly linked to commerce, and U.S.
business is widely engaged around the world with joint ventures,
partnerships, and economic linkages that require its employees to have
international expertise both at home and abroad. A recent study on the
internationalization of American business education found that
knowledge of other cultures, cross-cultural communications skills,
experience in international business, and fluency in a foreign language
ranked among the top skills sought by corporations involved in
international business. Despite new efforts to internationalize
business education in the last decade, U.S. business schools continue
to fall short of fulfilling the need of businesses for personnel who
can think and act in a global context.
Title VI supports important programs that internationalize business
education and help small and medium-sized U.S. businesses access
emerging markets, a boost toward reducing the trade deficit and
creating U.S. jobs. The U.S. Department of Commerce reports that 97
percent of all U.S. export growth in the 1990s was contributed by small
and medium-sized companies, and yet only 10 percent of these companies
are exporting. The most common reason cited by U.S. businesses for not
pursuing export opportunities is a lack of knowledge and understanding
of how to function in the global business environment.
In addition to business, the ubiquitous nature of globalization
also is driving new demands for globally competent citizens and
international knowledge in almost all fields of endeavor, such as
health, the environment, and law. Whether it be in the culturally
diverse U.S. workplace or on assignment abroad, employers increasingly
look for candidates who have cross-cultural skills, foreign language
proficiency, and the ability to meet the international challenges of
their field. Increasing the pool of underrepresented minorities who
pursue international careers is a critical dimension as well.
Title VI and Fulbright-Hays programs support projects to infuse
foreign language, area and other international studies into the
curriculum and across disciplines, from K-12 through professional
education. They support increasing the capacity of predominantly
minority-serving institutions to produce globally competent graduates
who enter the international service. Extensive outreach programs serve
government, education and corporate needs for international knowledge.
Finally, it does not appear that our education system is positioned
to produce the increasing numbers of international experts needed, or
even ordinary citizens who are globally competent. Recent studies and
surveys suggest that overall our education institutions are falling
behind in international education:
--The vast majority of students is being provided with only
rudimentary levels of international skills and competencies;
--Foreign language enrollments in United States higher education fell
from 16 percent in 1960 to just 8 percent today and the number
of 4-year colleges with foreign language entrance and
graduation requirements also declined. On the positive side,
foreign language enrollments in community colleges and at the
K-12 levels are increasing;
--There is a shortage of trained teachers and faculty in foreign
languages, especially the less commonly-taught languages, and
in area and international studies; and
--Only about 3 percent of United States students enrolled in United
States colleges and universities study abroad.
Title VI and Fulbright-Hays programs support the training of
teachers and faculty in foreign languages and international education.
They support overseas research, the development of study abroad
programs in underrepresented areas, research in the teaching and
learning of foreign languages, and the application of new technologies
to all of these efforts.
FISCAL YEAR 2002 FUNDING PROPOSAL
Funding for this account during President Clinton's Administration
did not keep up with increased national needs for global competence or
with increases in overall federal education funding. When adjusted for
inflation, the Department of Education's budget for discretionary
programs grew by about 50 percent since fiscal year 1994, while these
programs combined increased by only 14 percent. Despite the increase,
Title VI and Fulbright-Hays continue to be funded below their constant
dollar level of the late 1960s. (For example, only half as many Foreign
Language and Area Studies fellowships are being awarded today, compared
with fiscal year 1967.) Moreover, funding for the Institute for
International Public Policy has not been increased since its inception
in fiscal year 1994.
Our 3-year strategic plan proposes three policy goals to meet the
growing national needs described above:
--Increase the production of the nation's international expertise and
knowledge to meet national strategic needs;
--Enhance the knowledge and skills of our citizens for a global
workplace; and
--Expand education, government and private sector access to
international expertise and knowledge (outreach and
dissemination)
To address these goals, we recommend as a first year installment, a
total of $96.32 million for the International Education and Foreign
Languages Studies account. This represents an $18.3 million increase
over fiscal year 2001.
We recommend our proposed increase be allocated as follows:
--A $13.5 million increase in Title VI-A & B domestic programs ($80.5
million in total). Title VI-A & B programs ensure a national
capacity of expertise and knowledge in foreign languages, area
and other international studies, including international
business education. The proposed increase would strengthen
activities addressing national strategic needs and shortfalls
in capacity: (1) training the next generation of experts and
producing research on the foreign languages, world areas and
global/regional issues of emerging economic and security
importance; (2) infusing foreign languages and area studies
into the professional disciplines; (3) increasing outreach and
linkage activities to government agencies, business, the media,
and education institutions; (4) accessing and making widely
available expensive foreign information resources using
innovative applications of technology; and (5) enhancing the
knowledge, understanding and skills of our citizens for a
global workplace.
--A $3.3 million increase in Fulbright-Hays ($13.3 million in total).
Fulbright-Hays complements Title VI programs by providing U.S.
students, faculty and teachers a vital overseas research and
training dimension in foreign languages and area studies. For
example, in a recent survey of former doctoral dissertation
research abroad grantees, nearly all indicated they could not
have achieved their level of expertise without this support,
and that they utilized the skills gained abroad in teaching and
research. Yet under this program in fiscal year 2000, only 88
fellowships could be awarded out of an applicant pool of 417.
In recent years the average number of fundable applications for
all four Fulbright programs has been roughly double the number
actually awarded with available funds. An additional $3.3
million would enable about 75 more awards for doctoral
dissertation, faculty research, group projects and seminars
abroad.
--A $1.5 million increase for the Title VI-C Institute for
International Public Policy ($2.52 million in total). The IIPP
responds to the national need for a diverse pool of well-
trained, language-proficient professionals to enter the foreign
service and related careers. Students completing this program
have earned the distinction of passing the foreign service oral
exam on the first attempt. Level funding for the IIPP since
fiscal year 1994 has caused a scaling back of several program
components. An additional $1.5 million will enable full funding
of the graduate fellowships and reinstatement of the
institutional capacity--building grants to HBCUs, HSIs, and
other minority institutions, in keeping with the program's
statutory mandate.
We consider our request to be a modest one for programs vital to
our nation's long-term security and economic well being. Thank you for
your consideration and for the opportunity to express our views.
______
Prepared Statement of the Colonial Williamsburg Foundation
Dear Mr. Chairman: Colonial Williamsburg Foundation hereby submits
for the record, testimony regarding an electronic field trip project
called the ``Outreach Education Initiative.''
SUMMARY
Colonial Williamsburg, the nation's oldest and largest living
history museum, continues to inspire Americans. Our national history is
a dramatic story that continues to influence the present. The story of
America's colonial history and the coming of the American Revolution
are the heritage of every American. Colonial Williamsburg explores the
history behind the critical issues that still challenge American
society--how diverse people, holding different and sometimes
conflicting personal ambitions, evolved into a union that valued both
liberty and equality.
This history that defines us as a nation should be understood by
all school children. Technology is the means by which this message can
be clearly delivered to schools across America.
Each year, one million adults and children from all fifty states
and several foreign countries, visit Colonial Williamsburg's Historic
Area in person, including over 160,000 students on school study trips.
For most students, however, a personal visit to the Historic Area
is not a realistic option.
To reach students and teachers throughout the country, Colonial
Williamsburg launched its Educational Outreach Initiative with the
electronic field trip project in the fall of 1996. This initiative
takes the museum's dynamic methods of history education beyond the
streets and buildings of Williamsburg and transports them directly into
the nation's classrooms. Electronic field trips replicate, to the
greatest extent possible, an actual visit to Colonial Williamsburg and
create a palpable excitement for learning.
With the best technological communication resources at our command,
Colonial Williamsburg reaches millions of students and teachers
throughout the country. Through electronic field trips, this experience
is taken directly to the nation's classrooms. These programs currently
reach an estimated one million registered students in forty-six States
with a total viewing audience of more than five million unregistered
students and home viewers.
Colonial Williamsburg's Electronic Field Trips--``lightspeed
learning'' experiences--are live, interactive television programs,
linked to comprehensive teacher's guides, and Internet activities and
discussion groups. Several weeks before each program airs, registered
schools receive a teacher's packet, which includes an instructional
videotape and short introduction to Colonial Williamsburg, a
comprehensive teacher's guide, full-color classroom poster, and links
to national standards of learning. The teacher's guide includes
historical background materials, facsimiles of historical documents and
prints, photographs of Colonial Williamsburg and its costumed
interpreters, glossaries, timelines, and several suggested lesson plans
written by classroom teachers.
Electronic field trips are eight live broadcast events each school
year. Each field trip consists of two or three historical dramas
depicting aspects of eighteenth-century life, ranging from a young
recruit's view of military preparations for the Revolution to a free
black man's efforts to buy his wife's and children's freedom from their
owner.
After each dramatic vignette, students from registered schools can
speak directly to the historical interpreters on live television,
asking questions and expressing opinions about the issues presented in
the programs. Those students that do not make it on air can speak via
the telephone and the Internet to more than thirty interpreters and
historians behind the scenes. During an electronic field trip, Colonial
Williamsburg staff will respond to over 1,300 phone calls in four hours
and reply to as many as 1,000 email and Internet bulletin board
inquiries. Students can also vote on issues raised during the program
to see how their votes compare with others across the country.
The field trips are also much more than history lessons. History is
just a starting point for high-tech interdisciplinary learning in
civics, mathematics, science, art, and government, and an excellent
venue for honing critical thinking skills--so necessary for creating a
job-ready work force.
Through the electronic field trips Colonial Williamsburg is able to
teach our country's history and encourage the use of technology in the
classroom for a wider audience. Here's what one California teacher had
to say about the impact of an electronic field trip on her classroom
and on one ``at-risk'' student in particular:
``One of my boys, who is an at-risk student and who has had lots of
problems, was able to get on the air with his question and was so
excited! He was the fifth grade star because the other fifth grade
classes were also watching the program to hear his question. . . . The
kids are now primed for our study of the American Revolution.''----
Sally White, Teacher, George White Elementary School, Laguna Niguel,
California
AUDIENCE SERVED
The target audience for Colonial Williamsburg's electronic field
trips includes the nation's entire student population, generally
students from fourth through twelfth grade.
Extrapolating information from registered schools and the number of
students asking questions and voting via telephone and the Internet,
Colonial Williamsburg estimates that at least 500,000 registered
students actively participated in the 1996-1997 electronic field trips.
Current estimates predict that approximately 1 million registered
students will have participated in the 1999-2000 electronic field
trips, with a total viewing audience of more than 5 million.
Communities across the country are concerned about studies showing
the erosion of young people's American history knowledge and the need
for teacher and student training in the use of educational technology.
Last year Congress made additional funds available for history
education programs. Colonial Williamsburg's electronic field trips are
an important contribution to improving history education and helping
students become more knowledgeable and excited about the past while
relating it to their current environment.
Electronic field trips help students discover positive role models
from history to which all young people, from gifted to at-risk
students, can relate. They increase teacher familiarity with technology
and their understanding of appropriate methods for utilizing it. These
programs are standards--based in multiple disciplines, providing
opportunities to engage students in cross-discipline learning. They are
very low cost and accessible through almost any level of technology
available to the classrooms. In addition, Colonial Williamsburg staff
members work with teachers independently to help them get the most out
of the programs.
Colonial Williamsburg's electronic field trips provide
opportunities to integrate technology in the classroom and enhance
technical skills. Teachers and students in less-advantaged communities
might have access to communication hardware but don't have the training
to use those technology resources. Because information tools and
familiarity in using them are increasingly important to individual
success, it is essential to correct this imbalance. Technical
competence is integral to the success of today's students and
tomorrow's adults and, without such competence, a large portion of the
nation's citizens will be left behind, unable to compete, and
increasingly distanced from the means by which many people are
receiving information, producing work, and participating in their
communities.
METHODS
Begun in the fall of 1996, Colonial Williamsburg's Electronic Field
Trips craft comprehensive teacher materials, live interactive
broadcasts, and Internet activities into an interactive learning
experience for students. Each field trip follows a similar format
combining production, educational material, and new media components.
Production
The main component of each field trip is a live, one-hour,
interactive broadcast, offered twice on the broadcast day so that
students in all United States time zones can participate. Each program
is of broadcast quality and is sent via satellite, as well as via
public and educational broadcasters, to schools across the United
States.
Colonial Williamsburg historical interpreters host each program,
introduce students to life in colonial America, and are available for
questions from registered viewers.
Interaction--the exchange of ideas and opinions--is the heart of a
Colonial Williamsburg electronic field trip. The intent is to make
students feel as if they have traveled back to the eighteenth century
and are active participants in the process of history. Based on the
responses from teachers and students, this format works extraordinarily
well.
Traditional Educational Material
The teacher's guide includes historical background materials,
facsimiles of historical documents and prints, photographs of Colonial
Williamsburg and its costumed interpreters, and several suggested
lesson plans. Colonial Williamsburg's teacher advisors develop these
teacher guides and lesson plans. Because classroom teachers create
them, they are practical and useful. Feedback from educators indicates
that the teacher's guides are excellent resources, particularly the
primary source documents, which are often difficult for educators to
find.
Media Components
The Internet component of the field trips provides another venue
for the students to engage in interactive, distance learning. Each
field trip provides a forum that allows students to discuss issues and
ask questions of each other and of Colonial Williamsburg's historians.
The forum remains available throughout the school year so those
educators who wish to revisit the material later in the school year can
still interact with Colonial Williamsburg. Also, the teacher's guide is
available on-line along with several participatory student activities.
Student on-line activities provide an opportunity to explore topics in-
depth, and to extend and amplify the classroom and broadcast lessons.
PROJECT NEED
Colonial Williamsburg believes that Thomas Jefferson was correct:
an educated populace is essential for the maintenance of a free
democracy. The fundamental premise of our government is that political
power derives from the informed consent of the people, which, we
believe, can come only from knowledge and understanding of the people
and events that shaped American society. Through historical knowledge,
Americans come to appreciate their pluralistic society and see other
racial, ethnic, and religious groups as part of the nation's genius and
strength. An understanding of the principles on which this country was
founded is indispensable in the development of an informed citizenry.
Furthermore, the study of history promotes the critical thinking skills
that are so necessary for a job-ready work force.
An increasingly disturbing portrait of American education is
emerging from research on schools; parents and educators alike are
concerned about students' lack of knowledge and preparation. Often, in
the efforts to address deficiencies in language arts and math skills,
history is virtually left out of the curriculum. Many elementary school
teachers do not receive enough exposure to the subject during their
classroom training. Students who can keep pace with state-of-the-art
computer technology may find little to capture their imagination in
events that took place decades or centuries ago. As a result,
youngsters simply do not form a basic understanding of American history
and, therefore, are not interested in the subject.
Schools nationwide are finding that resolving the crisis in
education calls for a new pedagogy. Many schools, particularly those
that and present the classic profile of a student population at risk,
are struggling to make instruction both meaningful and effective and
fun.
The confluence of several successful Colonial Williamsburg programs
and the needs of the schools suggests that now is the time to create a
comprehensive program targeting both teachers and students in our
nation's school system and promote a renewal of history education.
request
While Colonial Williamsburg currently reaches over one million
registered students with innovative, state-of-the-art programs, we feel
we have an obligation to help more schools and students better
understand the history of our nation. Recently, Colonial Williamsburg
received a private donation of $5 million to endow the Electronic Field
Trip programming.
As stewards of an important segment of our American heritage, we
are asking for a one-time appropriation of $5 million to leverage with
the $5 million private endowment. Federal money would allow Colonial
Williamsburg to do the following:
--Support distribution of the video program across the country.
--Support the further development of web casting.
--Support coordination with the various state standards of learning.
--Support disadvantaged schools to integrate technology and education
in their schools.
The Colonial Williamsburg Foundation wishes to express its deep
appreciation to this Committee for permitting us to submit this
presentation on the ``Outreach Education Initiative.'' Your positive
response for Colonial Williamsburg's request for support will have a
positive impact on our nation's education crisis by teaching history to
our children.
______
Prepared Statement of Florida State University
Mr. Chairman, I would like to thank you and the Members of the
Subcommittee for this opportunity to present testimony before this
Committee. I would like to take a moment to briefly acquaint you with
Florida State University.
Located in Tallahassee, the capitol of Florida, FSU is a
comprehensive Research I university with a rapidly growing research
base. The University serves as a center for advanced graduate and
professional studies, exemplary research and top quality undergraduate
programs. Faculty members at FSU maintain a strong commitment to
quality in teaching, to performance of research and creative activities
and have a strong commitment to public service. Among the faculty are
numerous recipients of national and international honors, including
Nobel laureates, Pulitzer Prize winners as well as several members of
the National Academy of Sciences. Our scientists and engineers do
excellent research, have strong interdisciplinary interests, and often
work closely with industrial partners in the commercialization of the
results of their research. Having been designated as a Carnegie
Research I University several years ago, Florida State University
currently is approaching $125 million per year in research awards.
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 to our campus.
At Florida State University, we are very proud of our successes as
well as our emerging reputation as one of the nation's top public
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 upper-division programs entirely online for
students to receive their baccalaureate degree in Computer Science,
Information Studies, and Software Engineering--all areas central to our
economy. An essential part of this program is the use of mentors, who
take a proactive stance toward the students, contacting them on a
regular basis to provide assistance, and are available electronically
to students as needed. Student mentoring is key to insuring successful
outcomes in distance courses.
This program is a model of effective distance learning that can be
used 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, additional 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 expenditures to add majors,
train mentors and offer degree programs on a larger scale.
Additionally this year, we plan to address the issue of preparing
students to become K-12 teachers. Governor Bush has stated that he
would like to see teachers trained both by traditional and alternative
means and wants skills of current teachers to include the use of
technology. We will utilize the same articulation we have between the
AA and the bachelor's degree in Florida to offer first the general
teacher certification courses online, then begin placing specific areas
of certification online. In addition, we plan to build on our ``Troop-
to-Teachers'' project and have a robust alternative certification
program available online. Many qualified people in mid-life or retires
who may want to become teachers are discouraged by the typical format
for teacher certification which requires then to return to a campus to
take undergraduate courses. The state of Florida is pioneering with an
alternative certification program that allows the local school board to
certify teacher if they go through a process while employed at the
school. Florida State has take the first steps in developing an online
curriculum for alternative certification that could be used by any of
Florida's 67 school districts, and for that matter anywhere else in the
country where the alternative certification model is employed. It is
being piloted in two school districts this year. We will service
students in Florida and will expand to draw students from other states
that plan to relocate to Florida. Further, this can serve as a
demonstration project which if successful could be adopted across the
nation to help alleviate our teacher shortage. We will do this with the
guidance of the recent reports--the first, Investing in Teaching, which
was prepared by a consortium composed of The Business Roundtable, the
National Alliance of Business, the National Association of
Manufactures, and the US Chamber of Commerce. The other report,
Professional Standards for the Accreditation of Schools, Colleges and
Departments of Education, has been published by the National Council
for Accreditation of Teacher Education (NCATE).
Florida State University is heavily invested in new technologies
and learning and is ideally positioned to provide further leadership in
student supported high quality distance learning. Last year, FSU
received $170,000 in fiscal year 2001 to begin its efforts. We are
seeking an appropriation of $3 million within the Department of
Education's Fund for the Improvement of Post-Secondary Education
account to continue and expand this activity in fiscal year 2002.
Finally Mr. Chairman, I would like to discuss construction needs of
the FSU College of Medicine. Last year, the State of Florida approved
the establishment a Medical School at Florida State University. The FSU
College of Medicine is the first medical school to be established in
the United States in a quarter of a century. This initiative is a major
opportunity for FSU and will be a tremendous asset to the State of
Florida. By establishing this medical education program in a unique
fashion, which is our plan, we are convinced that its creation can have
a national impact on medical education. The University is seeking to
implement this new approach to medical education in extremely
innovative and nontraditional ways, and we will be doing so in an
efficient fashion that will meet today's and tomorrow's challenges to
the practice of primary care matched with Florida's unique
demographics. The College's focus will not be on centralized campus
clinical care facilities. We intend to maximize the University's
statewide visibility to create networks of collaborative relationships
with public health clinics, hospitals, and other primary health care
delivery systems throughout the State. We will employ approaches that
include unique and extensive distance learning technologies,
telecommunications and telemedicine capabilities; we will focus on
public, community, and rural health; we will develop expertise and
interest in health policy issues, health statistics, and demographic
research; we will focus on an aging population; and we will emphasize
health professions development. The University will build upon existing
strengths in many of these areas to create a truly unique medical
resource of the State of Florida and the nation.
Florida State University has already received $30 million from the
Florida legislature over the past two years for a new basic sciences
building to be used for the College of Medicine. There is another $15
million requested in Governor Bush's budget pending with the
legislature at this time. The estimated cost of the medical building is
$60 million. We are requesting the remaining funding, $15 million, to
be secured from HRSA, which will allow us move forward with the
building of this facility, and will ultimately allow FSU's new College
of Medicine to becomes a reality. This investment will have lasting
results that will greatly benefit both Florida and the nation.
Mr. Chairman, these are just a few 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 National Military Family Association, Inc.
Mr. Chairman, the National Military Family Association 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 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 2001. 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 families move an average of every 2.9 years, three times
the rate of their civilian counterparts. Military children
attend an average of six different schools during their K-12
education. 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, military children sometimes lose
credits needed for graduation. Currently 18 states have
graduation requirements linked to performance on state exit
exams; 6 more states are developing exit exams. With the rise
of exit exams and increased graduation requirements, transfers
in the last year or two of high school are becoming more
problematic. A change of schools at any time is traumatic, but
a change in the middle of the school year is especially so. A
midyear transfer can place some children so far behind that
they cannot catch up the rest of the school year.
--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, and 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.
Today's military force is an educated force and military members
have high expectations for their children's education. More are
accepting or rejecting assignments, or even deciding to leave the
military, based on perceptions about the quality of education their
children will receive at prospective duty stations.
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. What they do not understand is that Impact Aid funds fall
short of the levels intended by the creators of the program or of the
amount needed by their children's schools.
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 the
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 termed ``military 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 (termed ``military B''
students).
NMFA thanks this Subcommittee and the Congress for its continued
funding of Impact Aid for the military children who live off the
installation, the military Bs. Two-thirds of military families live
off-base. 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.
Military children, whether living on- or off-base, impose costs on the
district as they move in and out: records must be prepared, evaluations
and testing must be done for special programs, transition labs or
remedial programs may be needed.
NMFA is grateful to the Congress for recognizing the costs imposed
on school districts by the military B students and the inadequacy of
the B's weighting at only one-tenth of the payment made for on-base
students. The increased weight to two-tenths of the on-base payment
included in last year's reauthorization of the Impact Aid program was
an important step in providing districts that serve these children with
the funding necessary to meet their responsibility for educating them.
Funding for these children will become even more crucial for school
districts as the military Services increasingly look to the civilian
community to provide more housing for military families. Funding for
military Bs will also be important to districts serving installations
building privatized housing in civilian communities off-base rather
than on the installations. Although developers may be paying some
taxes, these revenues may be inadequate, especially during the early
years of the privatization contracts.
The administration's fiscal year 2002 budget proposal included a
request for Impact Aid basic support at the fiscal year 2001 funding
level rather than the smaller request we had come to expect from
previous administrations. We note, however, that the increased weight
now provided for off-base students will result in smaller payments for
some districts unless more money is provided for basic support. We
would hate to see that a much-needed change to help districts educating
many off-base children would be paid for by districts supporting large
numbers of on-base military children.
A well-funded Impact Aid program enables districts serving large
numbers of military children to approach the level of educational
opportunity available in neighboring, non-impacted school districts
even though they do not have access to the same kind of tax base.
Impact Aid dollars are targeted to districts where the Federal
responsibility is the greatest under the law. The dollars go directly
to school districts with no strings attached. The local community, the
people with the greatest stake in the quality of education in their
schools, decides how Impact Aid funds will best serve the basic
education needs of all students.
FAMILY HOUSING PRIVATIZATION: A CAUTIONARY NOTE ON EDUCATION FUNDING
NMFA has supported the concept of privatization of military family
housing as essential for increasing the amount of capital available to
eliminate the backlog in substandard housing. However, we caution
installation leaders and wish to inform policymakers of privatization's
unintended consequences on both family budgets and school district
funding. The law requires that servicemembers living in privatized
housing be paid Basic Allowance for Housing (BAH), which is then turned
over to the developer as rent. Eligibility for safety net programs
administered by the U.S. Department of Agriculture such as food stamps;
the Women, Infants, and Children (WIC) nutrition program; and free and
reduced price school lunches is based on a family's total income. When
an installation's housing is privatized and servicemembers start
receiving BAH--which is immediately passed to the developer via an
allotment--the total income as indicated on the member's Leave and
Earnings Statement (LES) seems to have increased. Many servicemembers
then lose eligibility for safety net programs. Press reports state, for
example, that two-thirds of the families receiving food stamps on Fort
Carson, CO, lost their eligibility once the housing was privatized.
When families lose eligibility for free and reduced school lunches,
their local school can also lose other funding. Federal Title 1 and E-
rate technology funding as well as some state funding is based on a
school's poverty rate, which in turn is based on the percentage of
children receiving free and reduced lunches. Fountain-Fort Carson
District 8, a district of approximately 4,900 children, reports that it
received $400,000 less in funding from these sources in the year after
installation housing was privatized and servicemembers on Fort Carson
began receiving BAH. NMFA urges the Departments of Defense,
Agriculture, and Education to examine how school funding can be
protected during the implementation of privatization projects.
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 the latest move. Unfortunately, too many military
children must deal with those anxieties in a school facility that has
seen better days. Their military parents see the deteriorating school
building as perhaps a symbol of a deteriorating respect for their
service to the country. Although Impact Aid provides much of a heavily-
impacted district's working capital, a district's payment cannot
usually 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. Obtaining funding to construct and renovate
school buildings is a challenge for school districts across the
country, not just districts receiving Impact Aid; many U.S. school
buildings were built in the fifties and sixties and need major work to
meet handicapped accessibility standards and to be able to handle
modern technology. The reduced tax base of districts dependent on
Impact Aid often makes it difficult for these districts to float the
necessary bond issues to construct new schools or renovate existing
buildings.
NMFA remains concerned about the inadequate funding to upgrade and
maintain buildings owned by the Department of Education. The co-
terminous districts--those civilian districts whose boundaries are the
same as the military installations they serve--have received funds in
recent years out of the Department of Defense budget to help with
repair and renovation projects. Some of these districts have school
buildings owned by the Department of Education. Even with the DOD
funding, these districts still face difficult prioritization decisions
on how to address facility shortfalls. Randolph Independent School
District, serving Randolph Air Force Base in San Antonio, TX, estimates
that it needs $14 million to meet the facility needs in its Department
of Education-owned buildings. The district must address safety and
structural needs before addressing a priority of many military
families: renovating a room that is too small to accommodate the
district's award-winning band.
Other districts, with a mix of schools owned by the district and by
the Department of Education, have not received the funding they have
needed to take care of these buildings. They have been forced to use
district funds to bring the Department of Education-owned buildings up
to district standards so that the military children attending these
schools will not fall behind their peers in district-owned buildings.
NMFA is pleased to note the increased amount requested for construction
in the administration's budget proposal and urges Congress to allocate
adequate construction funding in the Impact Aid budget for districts
that do not have other funding alternatives available.
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 California, to another Impact Aid school in Texas, to a
Department of Defense school in Japan, to an Impact Aid school in
Kansas--the quality of education she receives in one school may well
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
around the world, 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.
Recognizing that servicemembers 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. The Services are adopting proposals to facilitate parent
involvement in schools, such as the policy at Fort Hood, TX and other
installations that states a servicemember's place of duty is the
scheduled parent-teacher conference. The Army has addressed the
difficulties students' face when moving in their senior year by
recently instituting a Senior Stabilization Policy that enables the
soldier to request a delay in PCS orders so that a rising senior can
finish high school at the current location. Personnel are working
across the Services on common issues and are reaching out to military-
related and education organizations. NMFA applauds DOD's creation of
the Educational Opportunities Directorate to address the needs of all
military children wherever they go to school. The Directorate has
established a Special Needs Website (www.mfrc.calib.com/snn) as a
resource for military as well as for schools and service providers. The
Directorate is currently conducting a series of roundtables in states
with high military populations to raise awareness of issues affecting
the mobile child among parents, state and local education policymakers,
and installation officials.
School districts are responding to military families' concerns
about quality education and to the military Services' desire to develop
partnerships by devoting resources to training their personnel on
transition issues and to setting up more transition programs. They
recognize their interdependence and their shared responsibility for the
education of military children and are increasing their communication
with each other to ease children's transition in and out of different
school systems.
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 educational
conferences on 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 meeting the
Federal obligation to fully fund Impact Aid.
______
Prepared Statement of the United Tribes Technical College
SUMMARY OF REQUEST
For 32 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. Our request for fiscal year 2002 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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--$6 million, or $400,000 over the fiscal year 2001 enacted level.
This funding is essential to our survival as we receive no
state-appropriated vocational education monies.
In addition we request:
--Funding for renovation of our facilities, many of which are
original to the Fort Abraham Lincoln army installation and are
on the National Register of Historic Places. A recent study
commissioned by the Department of Education and submitted to
Congress shows a facility need for UTTC of $49 million.
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. We do not receive funding through
the Tribally Controlled Community Colleges Act.
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 371
students from 32 tribes and 14 states. And we serve 155 children in our
pre-school programs and 175 children in our elementary school, for a
direct services population of 701.
EDUCATING STUDENTS AND CONTRIBUTING TO THE ECONOMY
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. The average age of our students is
28. 68 percent of our students are female, and 45 percent of student
are single parents with an average number of dependents of 2.5. 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 1999 Labor Market Information On the Indian Labor Force.)
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 5 years
and an additional 12 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 is a major business contributor to the state of North Dakota.
We undertook a study of the economic impact for 1999 of our institution
on the state of North Dakota, and found, using only four key dollar
impact areas, the economic impact created by UTTC was $34 million. This
study did not encompass all the meetings and conferences that UTTC was
directly or indirectly responsible for bringing to Bismarck. Thus, the
economic impact in 1999 was even greater than indicated in our study
(``Economic Impact by United Tribes Technical College on the Bismarck-
Mandan Community and North Dakota--January 2001'')
UTTC NEW COURSE OFFERINGS
We offer 9 Certificate and 15 Associate of Applied Science degree
programs. 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
--Food and Nutrition
--Tribal management, including gaming management
--Computer Support Technician
--Distance Learning programs
Food and Nutrition/Diabetes.--UTTC 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 world.
About half of Indian adults have diabetes (``Diabetes in American
Indians and Alaska Natives, NIH Publication 99-4567, October, 1999).
The College currently offers a Food and Nutrition Associates to
increase the number of American Indians with expertise in human
nutrition and dietetics. Currently, there are only a handful of Indian
professionals in the country with training in these areas. Future
improvement plans include offering a Nutrition and Dietary Management
degree with a strong emphasis on diabetes education and traditional
food preparation.
United Tribes Technical College has also established the United
Tribes Diabetes Education Center to assist local Tribal communities and
UTTC students and staff in decreasing the prevalence of diabetes by
providing diabetes educational programs, materials, and training.
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.
Computer Support Technician.--High demand exists for computer
technicians. In the first year of implementation, the program is at
maximum student capacity. In order to keep up with student demand, UTTC
will need more classroom space, computers and associated equipment, and
instructors. Our program includes all of the Microsoft Systems
certifications which translates into high income potential.
Distance Learning.--We are bridging the ``digital divide'' by
providing web-based education from our North Dakota campus to American
Indians residing at other remote sites, including the Denver Indian
community. Training is currently provided in the areas of Early
Childhood Education and Computer Literacy. By the year 2005, students
will be able to access full degree programs in Computer Technology,
Injury Prevention, Health Information Technology, Early Childhood
Education, and Office Technology, and others from these remote sites.
Online education allows all American Indians an opportunity to overcome
barriers such as geographic isolation and access to culturally relevant
education. Through partnership programs, UTTC is meeting the challenge
of providing technology skills and training to Indian country.
In addition, UTTC has been a member of the Interactive Video
Network of North Dakota's colleges, universities, and tribal colleges.
This allows for collaborative arrangements with other colleges and
universities, expanding the educational opportunities for our students.
OTHER UTTC INITIATIVES
Northern Plains Bison Research.--UTTC is coordinating reservation-
based field research under the Northern Plains 1862/1994 Land Grant
Institutions Bison Research Collaborative. The overall project goal is
to enhance the quality of prairie rangeland conditions that will
sustain the spiritual and physical well being of Tribal bison herds.
Research activities are focused on the habitat and nutrition needs of
bison herds on North and South Dakota reservations.
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 their economies and buffalo herds.
Coordination with State Welfare-to-Work Efforts.--UTTC is working
in cooperation with the state of North Dakota and Tribal JOBS programs
on addressing the effects of welfare reform. The campus Child
Development Center provides early childhood services for 91 families.
This includes an Extended Care program so that students are able to
complete TANF work requirements, complete Cooperative Education
internships with private employers, and complete other work activities.
In North Dakota, only 33 percent of state TANF recipients are
allowed schooling as a work activity. The 12-month statutory limit on
length of time a TANF recipient can be enrolled in a vocational
education course of study presents additional barriers for single
parent families. This limits TANF recipients to taking 1-year
certificate courses at UTTC. Our experience shows that the students who
graduate from a 2-year, rather than a 1-year, course of study have
significantly higher earning power. Many of our students come to UTTC
planning to take a 1-year course, and then, finding themselves in a
supportive environment and seeing the economic benefit of the longer
course, decide to work for the 2-year degree.
NEW STUDY DOCUMENTS OUR FACILITY NEEDS
The 1998 Perkins Act required the Department of Education to study
the facilities, housing and training needs our institution. That
report, conducted for the Department of Education by the American
Institutes for Research, was published in November 2000 (``Assessment
of Training and Housing needs within Tribally Controlled Postsecondary
Vocational Institutions, November 2000, American Institute of
Research'') The report identified the need for $16,575,300 for the
renovation of existing housing and instructional buildings ($8 million
if some existing facilities are converted to student housing) and
$30,475,000 for the construction of housing and instructional
facilities. Our core facilities range from 90 to 100 years in age.
Originally the site was a military post built as Fort Abraham Lincoln.
UTTC acquired its use and eventual ownership in 1968.
If not adequately addressed, these costs will inevitably continue
to grow as the buildings age and inflation rises. The following needs
must be addressed if the College is to remain in existence and increase
its capacity.
Housing.--UTTC continues to identify housing as its greatest need.
UTTC has a huge waiting list of students--some wait from one to 3 years
for arrival. New housing must be built to accommodate those on the
waiting list as well as to increase enrollment. Existing housing must
be renovated to meet local, state, and federal safety codes. In the
very near future, some homes will have to be condemned which will mean
lower enrollments and fewer opportunities for those seeking a quality
education. Single student housing must also be built and expanded to
meet the College's needs.
Classrooms & Offices.--This type of space is at a premium. The
College has literally run out of space. This means that the UTTC cannot
expand its course offerings to keep up with job market demands. Most
offices and classrooms that are being used are quite old and are not
adequate for student learning and success.
OTHER AREAS OF NEED
Devastating Utility Increases.--Utility costs have skyrocketed due
to increases in natural gas. UTTC's utility costs have increased by 65
percent. This has put a major added burden on the school and is causing
a funding dilemma, since we do not have the option of relying on state
appropriated resources or other fixed cost revenues.
Inadequate Salaries.--We were able to provide a cost-of-living
increase for our employees last year. However, our faculty and staff
still receive salaries that are lower than any state college system in
the 50 states. (Source: Integrated Postsecondary Education Data Systems
Report of the U.S. Bureau of the Census and the Department of Education
Office of Education Statistics.)
Course Offerings/Student Services.--We hope 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.
______
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 $13 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 the Crownpoint Institute of Technology
This testimony addresses appropriations under The Carl D. Perkins
Vocational Education Act, Section 117 ``Tribally Controlled Vocational
and Technical Institutions.'' On behalf of the Crownpoint Institute of
Technology, (CIT), I thank this Subcommittee for providing very
necessary and deeply appreciated appropriations to Section 117 for
tribally controlled vocational educational institutions. CIT is aware
of only two such institutions in the nation. Funding to the U.S.
Department of Education by this Appropriations Subcommittee for Section
117 has enabled CIT to provide vocational and technical education and
training to over 400 students annually. CIT graduates enter our
nation's workforce with highly marketable employment skills.
While this appropriation has been greatly appreciated and extremely
well-utilized for the education of Native American young adults, CIT
believes the most significant situation relevant to Section 117
appropriations is that on March 27, 2001 the U.S. Department of
Education unexpectedly issued new regulations and application
guidelines that drastically redirect this appropriation. The Department
ruled that minor changes in the 1998 reauthorization to Section 117
constituted a ``substantial revision,'' and therefore expanded
eligibility to tribal institutions already supported under other
statutes. CIT does not agree that Section 117 of the reauthorization
law was revised. Attached with this testimony is a side-by-side
comparison of the 1990 and 1998 ``Tribally Controlled Postsecondary
Vocational Institutions'' definitions demonstrating that there are no
substantial revisions to the definitions of eligible institutions. Our
most important request to this Subcommittee is for assistance and
intervention in ensuring that the intent of the Congress is carried out
in the Department's awarding of funds under Section 117 beginning with
fiscal year 2001 appropriations which this Department of Education
March 27, 2001 Notice redirects effective May 29, 2001.
The Title for Tribally Controlled Postsecondary Vocational
Institutions was enacted to create a stable base of operational support
for those tribal colleges that were not eligible for the ``Tribally-
controlled Community Colleges Assistance Act.'' That 1978 act followed
the U.S. Congress policy of Indian Self-Determination, which allowed
tribes to manage their own institutions, and provides basic operational
support for tribal colleges through Interior appropriations into the
present time. The Tribal Colleges Act supports all but two of the
nation's tribally controlled colleges. The Crownpoint Institute of
Technology (CIT) is one of these two excluded tribal colleges. The
reason for the exclusion is a provision in the Tribal Colleges Act that
limits each Tribe to one college. On its surface this statutory
limitation may seem reasonable. The average population of tribes having
tribal colleges ranges between 3,000 and 10,000 members. The Navajo
tribe is a population anomaly among Indian tribes with 225,298 members
as verified by the most recent U.S. Census. Dine College, Tsaile,
Arizona, is the Navajo Tribal College funded under Interior's Tribal
Colleges Act. Founded in 1969, Dine is the first of the nation's tribal
colleges. CIT was founded in 1979, one year after enactment of the
Tribal Colleges Act and even then was originally created as a job
skills center. The ensuing decade saw CIT's evolution from a job-
training center to a full-fledged vocational technical college. Skilled
employment opportunities expanded for students graduating with
credentialed degrees, and CIT earned full institutional accreditation
from North Central Association of Colleges and Schools in 1987. CIT's
outstanding success at providing its students with highly marketable
career skills has enabled over 4,000 Navajo adults to leave the welfare
roles behind forever. This is how the Navajo Nation came to have a
second college.
The size of the Navajo population warrants a second college.
Throughout our nation, colleges are created to serve population bases.
The number of tribes is irrelevant. There are sixteen Indian tribes in
the three States of Montana, North Dakota and South Dakota. Each of
these tribes has a tribal college supported by Congressional
appropriations. Yet the combined population of on-reservation, all-ages
of these sixteen tribes is 72,835. An enrollment base establishes the
need for any educational institution. It is illogical by any standard
to erect sixteen colleges for a 73,000 population, while simultaneously
limiting a 225,000 population to only one college. However
inadvertently, this is exactly what the Congress did in 1978 with
enactment of Public Law 95-471, ``The Tribally Controlled Community
Colleges Act.''
Geographic access to postsecondary education is another significant
factor in establishing the need for a college, and was a primary
consideration for most tribes in founding their own colleges. The
Navajo Nation is 26,897 square miles extending into three States:
Arizona, New Mexico and Utah. The Navajo Nation reservation is 2,810
square miles larger than the State of West Virginia, and only slightly
smaller than the five New England States of Vermont, New Hampshire,
Massachusetts, Connecticut and Rhode Island combined. The driving
distance across this reservation is approximately nine hours. In the
remote vastness of this reservation in America's Southwest, geographic
access to postsecondary education for Native people would not exist for
most citizens without these two tribal colleges.
The existing tribal colleges adamantly opposed many years of CIT's
efforts to amend the Tribal Colleges Act to allow a second college in a
situation of exceptional population. In 1990, Congress enacted the
``Tribally Controlled Postsecondary Vocational Institutions''
provisions to provide federal assistance to tribal colleges not
eligible for Interior appropriations under the Tribal Colleges Act. At
that time there were only two such colleges in the nation, and their
primary mission was and remains vocational/technical education. Thus,
the provision was included in the Carl D. Perkins Vocational Education
Act. The second of these anomaly tribal vocational colleges is United
Tribes Technical College (UTTC) located in Bismarck, North Dakota. The
four tribes of North Dakota charter UTTC that each already had an on-
reservation tribal college funded under the Tribal Colleges Act. More
than two decades after their founding, there remain only two tribal
vocational colleges in the nation, although during these same years
several new tribal community colleges have been added under the Tribal
Colleges Act. Each of those colleges is the only college that the
sponsoring tribe has chartered. The vast majority of tribes have never
founded a first tribal college. Due to the small populations of most
tribes, it is highly unlikely that any tribe other than the Navajo will
ever found a second tribal college. In the situation of the Navajo
people, remote geography and population uniquely combined to predicate
this unusual need for a second postsecondary institution.
The 1998 Reauthorization of the Carl D. Perkins Vocational
Education Act saw some major revision, but the Tribally Controlled
Postsecondary Vocational and Technical Institutions provision remained
essentially intact because the situation it addressed remained
essentially the same. Because Section 117 contained only minor changes,
Congressional sponsors did not accompany enactment with a statement of
the intent of the Congress. The absence of such statement of the intent
of Congress served as the Department of Education's justification to
abruptly proclaim on March 27, 2001, more than two and one half years
after 1998 enactment, that Section 117 definition of eligibility was
``substantially revised.'' In response, a colloquy by the authorizers
reiterating the intent of the Congress as to this provision was
published in the April 26, 2001 Congressional Record and provided to
the Department. Upon receipt of the requested clarification, the
Department declined to withdraw the competition, which expands
eligibility for appropriations to all tribal colleges, which already
receive their basic operational support under Interior's Tribal
Colleges Act. A technical amendment is in process. However, it is
unlikely that this amendment can be enacted in time to affect awards
under fiscal year 2001 appropriation because the Department's
unretracted grant application deadline is May 29, 2001 with the fiscal
year 2001 program year beginning the following month. This Subcommittee
increased the fiscal year 2001 appropriation from $4.6 to $5.6 Million,
under which CIT's student count allocation is desperately needed to
remain in operation. Under the Department's new guidelines, CIT would
lose at least 70 percent of its operational funding, and in a worst
case, would not even be one of the institutions selected in the
competition by the Department at all. In either case, CIT would not be
able to open its doors for classes in August 2001, and will be forced
to furlough employees beginning June 2001. Presently, CIT is only able
to renew faculty contracts provisionally, subject to continued Section
117 funding. The potential loss of faculty to other more secure
employment would have a devastating effect on CIT. We urge this
Subcommittee to do all in its power to intervene and ensure that its
fiscal year 2001 Section 117 appropriation is spent according to the
law and the intent of the United States Congress.
CIT believes it has established its merit as a tribal institution
worthy of federal assistance. CIT has an eight-year average student
retention rate of 95 percent, and an average job placement rate of 86
percent over the same period. CIT's current enrollment is 492 headcount
or 423 Full Time Equivalency/Indian Student Count, an increase of
thirty students over academic year 1999-2000. Through tribal HUD
assistance, CIT has expanded married/family on-campus housing to
accommodate those students possibly most in need of jobs, students with
dependant children. CIT is a dormitory-based institution and off-campus
housing in scarce. Each year, student applications continue to surpass
capacity and CIT has a waiting list of over 200 otherwise qualified
applicants.
CIT offers fully-accredited two year Associate of Applied Science
degrees and/or one year certificates in high employment demand fields
including Accounting, Administrative Assistant, Applied Computer
Technology, Automotive Technology, Building Maintenance, Carpentry,
Culinary Arts, Electrical Trades, Environmental Technology and Natural
Resources, Law Advocate, Legal Assistant, Nursing Assistant and
Veterinary Assistant. For academic year 2001-2002, CIT has prepared to
offer Dental Assistant and Health Technician in response to a high
employment demand and shortage of skilled workers in these fields. CIT
has already secured donated dental training equipment enabling it to
maximize its use of federal assistance in this program.
Over 10,000 young adults graduate from Navajo area high schools
each year. The decennial Indian population increase is 14 percent as
compared to only 8 percent for mainstream America. Median Native
American population age is now 27.4 years, 8 years younger than the
median age for mainstream America. CIT's average student age is 26,
although the actual range has been 18-64. CIT is open to and welcomes
all qualified Indian and non-Indian applicants, and as just one example
has retrained displaced non-Indian uranium workers from neighboring
towns. However, the primary mission for this institution is to rectify
the joblessness and hopelessness so prevalent among too many of the
more than 200,000 on-reservation people. CIT graduates earn an average
$15,075 average entry-level annual wage upon graduation. Each employed
graduate pays an average of $2,261 of their earnings to federal taxes
in the first year of employment alone. While tax contributions vary
according to number of dependents and other factors, in general wages
and tax contributions over an average thirty years of employment and
tax paying. CIT lacks institutional resources to track all of its more
than 4,000 graduates of the past two decades, but of those tracked, 61
percent are employed in private industry and do not rely on federal
appropriations for jobs. In an average lifetime of employment, CIT
graduates will return to the federal government the cost of its
investment many times over through tax contributions as well as through
remaining off the welfare rolls.
It will have been a tragic loss of the investment of two decades
that brought CIT to the educational institution it is today if federal
operational assistance is so abruptly withdrawn. Over the past decade,
a significant investment of tribal and federal funding has brought CIT
facilities up to the standards that ultimately result in CIT graduates'
abilities to succeed in the mainstream American economy. CIT opened its
state-of-the art Veterinary teaching clinic last year. This teaching
clinic will greatly enhance the way of life that remains traditional
for most Navajo people, which relies on livestock yield. Over three
years, a more than $4 Million EDA grant enabled the replacement of
trailers with actual classrooms. In addition, this same EDA funding
repaired dormitories damaged by years of soil contraction, an
unforeseen construction problem endemic to the Southwest when CIT was
originally built by the Federal Government. CIT Administrative
buildings, also damaged beyond repair by this same problem, were
replaced with new mobile units in order steer maximum facilities
improvements directly to the students. The Navajo Nation invested their
HUD funding to increase housing capacity for students with dependent
children. Sixteen of a projected thirty-two units now have resident
student families on their way to acquiring life-long employment skills
to support these families. The Navajo Nation sacrificed much to ensure
that CIT provides education equal to that provided in mainstream
America so that our graduates can compete on a level playing field. It
will be a tragic waste of this investment if federal assistance to CIT
is withdrawn by the Department's radical new funding interpretations.
We deeply thank this Subcommittee for all its assistance and urge that
it take all action possible to ensure that its appropriations reach the
recipients that the law specifies and that the Congress intended.
______
Prepared Statement of the Alpha One Foundation
Mr. Chairman and members of the Committee thank you for the
opportunity to submit testimony for the record on behalf of the Alpha
One Foundation.
THE ALPHA ONE FOUNDATION
The Alpha One Foundation is a national not-for-profit organization
dedicated to providing the leadership and resources that will result in
increased research, improved health, worldwide detection and a cure for
Alpha1-Antitrypsin (Alpha-1) Deficiency.
ALPHA-1 IS SERIOUS AND LIFE THREATENING
Alpha-1 is a genetic disorder that can result in devastating and
fatal lung and or liver disease that is often misdiagnosed as asthma or
Chronic Obstructive Pulmonary Disease (COPD). Alpha-1 afflicts an
estimated 100,000 individuals in the United States with fewer than
6,000 accurately diagnosed. Alpha-1 is a major cause for lung
transplantation in adults.
The pulmonary impairment of Alpha-1 causes disability and loss of
employment during the prime of life, frequent hospitalizations, family
disorganization, and the suffering known only to those unable to catch
their breath. Lung transplantation, with all its associated risks and
costs, is the most common final therapeutic option. Alpha-1 is the
primary cause of liver transplantation in infants and an increasing
cause in adults. Untreated individuals can have their life expectancy
reduced by 20 or more years.
Alpha-1 is a progressive and devastating disorder that in the
absence of proper diagnosis and therapy leads to premature death; in
spite of the availability of therapeutics and preventative health
measures that can be life prolonging.
the medical needs of the alpha-1 community have gone unmet
Alpha1-Antitrypsin Deficiency is a hidden killer that
desperately needs new therapies. It masquerades as asthma, chronic
usual obstructive lung disease and bronchiectasis. There is a lack of
awareness of the insidious nature of the early symptoms of the lung
disease associated with this genetic condition by both medical care
providers and the public.
Currently, the only specific therapy for Alpha-1 is intravenous
augmentation therapy produced from pooled human plasma at an average
annual cost of $50,000.00. This single source therapy, initially
marketed through the Orphan Drug Act, increases the plasma levels of
the deficient protein and appears to slow or halt the progression of
the pulmonary disease described above. Unfortunately, this therapy has
been in short supply over the past several years. During prolonged
shortages, individuals on therapy were forced to reduce the dosage of
drug being administered or prolong the duration of time between
treatments. No data is available concerning the potential efficacy of
these untested treatment regimens. As new patients were identified,
they were unable to obtain drug during these periods.
SUPPORT FOR RESEARCH
The Alpha One Foundation believes that significant federal
investments in medical research are critical to improving the health of
the American people and specifically those affected with Alpha-1. The
Foundation is supportive of the goal set by Congress of doubling the
National Institutes of Health (NIH) budget by fiscal year 2003. At the
proposed funding level NIH will be able to support the highest level of
new and competing research project grants, and the highest level of
total grants in NIH history.
It is fair to state that the support of this Subcommittee has made
a substantial difference in improving the public's health and well-
being. The Foundation requests that the increase in the NIH budget will
reflect an increase in the Alpha1-Antitrypsin Deficiency
research portfolio to achieve the following goals:
--The Promotion of basic science and clinical research related to the
AAT protein and AAT Deficiency.
--The funding to attract and train the best young clinicians for the
care of individuals with AAT Deficiency.
--The support for outstanding established scientists to work on
problems within the field of AAT research.
--The Development of effective therapies for the clinical
manifestations of AAT Deficiency.
10 SPECIFIC AREAS OF CONCERN
1. Increase the level of funding for investigator-initiated
research.--Our best ideas to cure and prevent Alpha-1 come from
individual scientists working in the laboratory and with patients. We
recommend that the NIH budget be increased to allow an increased number
of scientifically meritorious grant proposals that are investigator
initiated be funded.
2. Provide significant increases in federal funding to attract,
educate, and train more clinical and translational researchers.--We
need continued replenishment of leaders to bring findings from the
laboratory bench to the bedside. We must recruit new clinicians to
become involved in clinical research. This is becoming more and more
difficult as managed care tightens budgets and allows little if any
time for physicians to engage in research. We must address this issue
if we are to have the trained personnel needed to prevent and cure
Alpha-1 in the next 5 to 10 years.
3. Increase individual grants for scientific conferences and
workshops.--Increase the number and amount of grants available to
sponsor scientific conferences and workshops in order to increase the
promotion and participation in these forums.
4. Fund targeted screening and detection.--In 1989 the HHS National
Commission on Orphan Diseases estimated that only 30 percent of the 25
million patients suffering with rare diseases receive a diagnosis in
three to five years after the onset of symptoms. That works out to
about 7.5 million patients who are shuffled from specialist to
specialist, year after year. Fifteen percent, or 3.7 million people,
wait seven years or more. The average patient with Alpha-1 sees 5
physicians over 7 years before they are properly diagnosed. In addition
only 6 percent of those estimated to have Alpha-1 have been identified.
A targeted screening and detection plan should follow the
recommendations of the World Health Organization's report on Alpha-1
and promote appropriate treatment and positive health interventions.
Research has shown that early diagnosis and treatment leads to fewer
long term health complications and a better quality of life.
5. Establish ``centers of excellence'' to support proactive
initiatives in Alpha-1 treatment.--We must focus our efforts to further
reduce smoking, understand and improve dietary habits and undertake a
national effort to identify and test potential Alpha-1 patients in an
effort to offer the best therapies and life prolonging preventative
health strategies.
6. Initiate health surveillance for frequent plasma recipients.--
Blood carries inherent risks that increase for life-long recipients.
Although all plasma-derived products are virally inactivated, there are
concerns about new and emerging pathogens and their ability to be
transmitted through blood. Targeted surveillance of the Alpha-1
community would allow for an early warning system should such a threat
be present in the blood supply. Specifically, the Foundation welcomes
an evaluation of the experience of this long term and frequent
recipient cohort of pooled plasma derivatives.
7. Capitalize on the unprecedented number of opportunities to
create new therapeutics through increased funding and public-private
partnerships.--The medical needs of the Alpha-1 community will go unmet
without the development of new therapies. The final delivery of new
therapies depends on the overall process of drug development and
clinical trials, and in the case of therapies for orphan disease this
process is often burdensome and prohibitively expensive. Academic
institutions and the private sector carry out these expensive
processes. To fully leverage the strengths of these sectors and
validate new therapies there must be resources to fund the expedited
development of unprecedented and novel public-private partnerships.
8. Fund programs to improve the quality of life.--Alpha-1 is a
tragic disease that extracts a great deal in terms of human suffering
from its victims and their families. We must provide programs that
address critical issues such as pain and fatigue and end-of-life issues
for patients and families. Preventative measures, environmental
effects, psychosocial, economic and ethical issues related to Alpha-1
should be fully explored.
9. Fund initiatives that will address research questions dealing
with disparities in minority, and underserved populations, and
accelerate programs to ensure early detection, and treatment.--We must
make every effort to reduce and equalize disease rates across all
populations. The Foundation supports increased funding for programs
that ensure that all populations receive the benefit of research and
that health disparities do not continue among minority populations.
10. Adequately fund the Office of Rare Diseases.--Finally, the NIH
needs to ensure that all Americans, not just a select few, have access
to the incredible work being done at the NIH. Today, only ten cents for
each and every person suffering with a rare disease is dedicated to
ORD. We request a significant increase in this funding amount.
CONCLUSION
The Alpha One Foundation supports an increase of $3.4 billion for
fiscal year 2002, in the hope that this increased investment in the
National Institutes of Health will translate into an increase in the
resources dedicate to research and awareness of the devastating
disorder: Alpha1 Antitrypsin Deficiency.
______
Prepared Statement of the Association of Schools of Public Health
The Association of Schools of Public Health (ASPH) is the only
national organization representing the deans, faculty, and students of
this nation's 29 accredited schools of public health and graduate
programs seeking accreditation as schools of public health in the
United States and Puerto Rico. These schools have a combined faculty of
over 2,500 and educate more than 15,000 students annually from every
state in the U.S. and most countries throughout the world. The schools
graduate approximately 5,000 professionals each year. The 29 schools of
public health constitute a primary source of comprehensively trained
public health professionals and specialists in short supply to serve
the Federal Government, the 50 states and the private sector. Yet
according to the DHHS, public health professionals are in short supply.
On behalf of the 29 graduate schools of public health in the U.S.
and Puerto Rico, the Association of Schools of Public Health (ASPH)
hereby submits a statement for the hearing record on the association's
fiscal year 2002 appropriations requests for programs of primary
concern in the U.S. Public Health Service. There is a chart on page
five that outlines these recommendations. Consideration of these
requests by the Subcommittee is appreciated.
PREVENTION RESEARCH CENTERS (CDC)
The Congress established the CDC prevention research centers
program in 1985 to provide grants to academic institutions to fund
applied research programs designed to develop new and innovative
strategies in health promotion and disease prevention. Through this
program, faculty expertise of schools of public health is made
available to federal, state and local health officials, community-based
organizations and nonprofit organizations. Additionally, the centers
serve as sources of education and training for America's next
generation of public health professionals. Unfortunately, the funding
level for the program has never reached the level that Congress
intended when authorizing the program.
ASPH REQUEST
CDC currently funds 24 prevention research centers at schools of
public health and schools of medicine across the country. Each center
has a specific prevention research focus, based largely upon its
faculty expertise and geographic location. However, core funding for
prevention centers has been decreasing since the program was first
funded in 1986 from an average of approximately $800,000 per center to
the current year average of approximately $715,000 per center. ASPH
requests that the Congress increase the funding for this important
program from the current year level of $25 million to $40 million.
These funds will be used for the following purposes: to increase the
core funding of centers such that the average core award is $1 million
(as intended by the Congress) which would allow CDC the flexibility to
provide additional funding to centers which have undertaken a more
aggressive program; to provide sufficient resources to permit not more
than six new, competitively-selected centers; and to provide the
necessary resources for administration of an expanded program at CDC.
Each prevention research center (PRCs) taps into the long-standing
links that schools of public health have with their communities and
regions. Schools of public health faculty work closely with community
leaders in designing and applying prevention strategies and programs
that address the public health challenges facing these communities.
From Appalachia, Harlem, the Deep South, the Midwest, the Northwest
and the Southwest, the PRCs link diverse and geographically distinct
areas through a national network that tracks and translates prevention
research and best practices to applications in community-based public
health and disease prevention programs. Increasing funds for prevention
research centers in fiscal year 2002 will enable them to expand
community-based interventions further into communities, allowing wider
access to lifesaving research and interventions.
HEALTH PROFESSIONS TRAINING (HRSA/BHPR)
The Association of Schools of Public Health respectfully requests
that Congress provide at least $20 million for public health training
programs and preventive medicine residencies in the fiscal year 2002
appropriations bill. Of this amount, $10 million should support public
health traineeships and preventive medicine residencies and $10 million
should be dedicated to public health training centers at schools of
public health.
The Pew Health Professions Commission, in its 1995 report entitled
Critical Challenges: Revitalizing the Health Professions for the
Twenty-First Century, concluded that the demand-driven system in health
care will result in increased demand for public health professionals as
managed care organizations seek to hold health care costs down by
employing public health solutions to community problems.
Several public health workforce experts in both government and
academia estimate that as many as 80 percent of individuals currently
working in state or local health departments have no formal education
in pubic health. Furthermore, those same experts estimate that less
than 50 percent of the directors of the local health departments, many
of whom are MDs, have no public health training. There is a critical
need to provide these professionals with the most up-to-date public
health training available.
DHHS has listed personnel shortages in several public health
occupations.\1\ Many state/local health department directors have
reported that the lack of practical knowledge and skills in the core
sciences of public health and preventive medicine have restricted the
effectiveness of their agencies. In order to improve the quality of the
American public health infrastructure, we must provide adequate
training, education and continuing education to the public health
workforce.
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\1\ There is a large under-trained public health workforce of more
than 400,000 who have no public health degree, certificate, or
education in public health. This represents roughly four of every five
employees in public health. Without well-trained public health
professionals in various shortage disciplines, communities are left
vulnerable to increased infectious diseases, toxic environmental
situations, contaminated food, and other threats to public health.
Training for public health professionals is critically important in
medically underserved communities, where serving disadvantaged
populations is critical. There are only 2,755 physicians trained in
general preventive medicine and public health in the nation. The number
of physicians completing a preventive medicine residency has declined
by 25 percent during the last 5 years leading to major gaps in
preventive medicine expertise need for clinical prevention, community
public health, and health services organization/delivery. DHHS programs
are designed to address the problems identified above. The public
health traineeships provide support for students in shortage
disciplines including epidemiology, biostatistics, environmental
health, toxicology, public health nursing, public health nutrition,
preventive medicine, behavioral sciences and mental health. The
preventive medicine and dental public health programs support planning,
development or maintenance of residency programs and provide financial
assistance to residency trainees enrolled in these programs.
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Many national health groups--especially the maternal and child
health agencies and state/local health officials--agree that regional
shortages of adequately trained professionals present the most
significant barrier to providing population-based prevention
initiatives, in general, and ensuring the delivery of quality health
care to underserved individuals and underrepresented populations, in
particular. Health professionals trained to handle the unique demands
of rural and inner-city public health issues are in the shortest
supply.
ASPH REQUEST
The Association of Schools of Public Health (ASPH) is requesting
that the fiscal year 2002 HRSA budget include $20 million for public
health workforce training. Specifically, funding should be targeted to:
--Make public health/preventive medicine education more accessible;
--Create links between public health/preventive medicine education
and future trends in the practice of public health;
--Continued efforts to promote diversity in student populations;
--Provide education or training for students and preventive medicine
residents in practice-based sites instead of solely in the
classroom; and
--Develop educational methods and distance-based learning
technologies that ensure the ability of public health workers
to reach underserved populations.
RESPONDING TO BIOTERRORIST ATTACK
Public Health Preparedness Centers
Building upon an fiscal year 2000 investment of $2 million and
report language urging continuation of the program in fiscal year 2001
to conduct training for current state and local health department
employees, the Congress should include $10 million in CDC's budget to
continue public health education programs using distributed learning
technologies with the goal of training employees of state and local
departments of public health and community-based organizations to
detect, contain and respond to a bioterrorist attack. Such an action
would also provide critically needed training in the area of infectious
diseases as well.
The recent focus on a bioterrorist attack on the United States has
led many to question the ability of the current public health workforce
to deal with such an emergency. There has not been a case of smallpox,
for example, since the early 1970s--and few public health professionals
are trained to recognize the symptoms of this deadly disease. This lack
of formal training in infectious diseases extends to other biological
agents such as anthrax, tularemia, botulinin toxin and plague. In order
to detect and respond to a bioterrorist attack, the U.S. needs public
health professionals who:
--Can conduct epidemiological surveillance;
--Can design and use the tools to detect terrorist biological
attacks; and
--Understand the principles of containment.
ASPH REQUEST
We respectfully request that the Subcommittee include a total of
$10 million in the fiscal year 2002 CDC budget to provide for
professional workforce development services to public health and
community-based organization employees in order to detect and respond
to a bioterrorist attack. It is proposed that CDC select not more than
ten public health preparedness centers based at accredited schools of
public health to conduct distance learning and professional workforce
development activities. Outcomes of these programs would include:
--Offering high-level, in-depth biodefense and infectious disease
training to approximately 500 public health professionals in
state and local leadership positions (including large cities
and state departments of health) using the Internet and other
distance learning technologies;
--Offering basic biodefense and infectious disease training to
roughly 1,000 staff-level public health officers (such as
surveillance officers) through distance learning;
--Assessing the skills and readiness of public health workers to
respond to bioterrorist and other public health threats;
--Developing a comprehensive public health training curriculum
focused on detection and response to bioterrorist attacks to be
delivered through the Internet, or other appropriate mass
communication technology.
PREVENTION RESEARCH INITIATIVE (PRI)
Prevention research plays a critical role in reducing the human and
economic costs of disease. For example, the CDC has estimated that the
annual cost of cardiovascular disease in the U.S. is approximately $259
billion, cancer is estimated to cost $104 billion, diabetes is
estimated at $92 billion, Alzheimer's disease--approximately $80
billion, and arthritis about $65 billion. However, these costs can be
reduced through prevention.
The benefits of population-based prevention are astounding. The
Journal of the American Medical Association published a widely accepted
article in 1993 that estimates that ten percent of all early deaths in
this country can be prevented by medical treatment. By contrast, the
study found that population-wide public health approaches have the
potential to prevent up to 70 percent of these early deaths through
measures that target underlying risks, such as tobacco, drug and
alcohol use, diet and sedentary lifestyle, and environmental factors.
ASPH REQUEST
The Association of Schools of Public Health respectfully requests
that the Congress increase the funding for the CDC prevention research
initiative to $25 million in the fiscal year 2002 Labor, HHS and
Education appropriations bill. Such a program should focus on
conducting priority research in the following areas:
--Investigations into the epidemiology of disease, including
identification of social and behavioral determinants of
illness;
--Studies of means to ameliorate personal, social and environmental
factors contributing to disease onset or exacerbation;
--Investigations into the disproportionate disease burden among
underserved populations;
--Studies of vulnerable populations with a high disease burden;
--Studies on immunization strategies and of methods for and the cost-
effectiveness of population screening programs; and
--Studies into the means by which further decline in physical or
social functioning can be prevented in people already ill.
Finally, the program would serve to expand the capacity of CDC to
bring the benefits of prevention to the millions of Americans at risk
for unnecessary early death.
SUMMARY
In closing, we are spending billions of dollars on treatment of
chronic diseases and/or research to find cures for such diseases, while
at the same time using pennies of our health care dollars to find ways
to prevent them. For example, the U.S. Government spends approximately
$50,000 per year/per capita to train medical graduates; by contrast,
the federal share per year to train graduate public health students in
the United States is less than ten dollars per student.
Our training programs in schools of public health are focused on
prevention of disease and disability; our programs are steeped in the
basic public health sciences of epidemiology and biostatistics; and our
curricula have a population-based perspective. In short, our graduates
will be more likely to approach their jobs with a better understanding
of disease in populations and with keener sense of a whole spectrum of
interventions aimed at the environment, human behavior and lifestyle.
Federal support of these programs is a wise investment in the health of
the American people.
In addition to our requests, the ASPH wishes to go on record in
support of the fiscal year 2002 appropriations recommendations of the
following groups and coalitions that have or will submit testimony
before the Subcommittee:
--Ad Hoc Group for Medical Research Funding
--CDC Coalition
--Coalition for Health Funding
--Friends of AHRQ
--Friends of NIOSH
--Friends of Title V (MCH Block Grant)
--Health Professions and Nursing Education Coalition
--Injury Control and Research Centers Coalition
--Friends of NCHS
In addition, we want to express the support of ASPH for providing
$250 million to upgrade laboratory facilities at CDC. These facilities
are in desperate need of renovation.
ASPH requests, and those outlined by these coalitions, represent
needs assessments that were derived from the views and expert opinions
of this country's most respected administrators, scholars, scientists
and leaders in the public health sector. We know that the Subcommittee
members will take them into serious consideration when marking-up the
fiscal year 2002 appropriations bill.
Listed below are the ASPH fiscal year 2002 funding recommendations
for programs of primary concern to the academic public health
community:
[In millions of dollars]
CENTERS FOR DISEASE CONTROL AND PREVENTION:
Prevention Research Centers (PRCs)............................ 40
Prevention Research Initiative (PRI).......................... 25
Preparedness Centers (PHPCs).................................. 10
HEALTH RESOURCES AND SERVICES ADMINISTRATION:
Public Health Training Centers, Traineeships, Preventive
Medicine and Dental Public Health........................... 20
______
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Prepared Statement of the University of Cincinnati
Mr. Chairman and Members of the Subcommittee, my name is Dr. Donald
Harrison, and I am the Senior Vice President and Provost for Health
Affairs at the University of Cincinnati. As CEO of the Medical Center,
I am also administratively responsible for the University's
participation in the Health Alliance of Greater Cincinnati and for the
academic programs of the Colleges of Medicine, Nursing, Pharmacy, and
Allied Health Sciences. I am a practicing cardiologist with an
international patient base, and I have served as national president of
the American Heart Association and Vice President of the American
College of Cardiology.
I am here today on behalf of a coalition of 20 academic health
centers across the nation to highlight issues of concern to all
academic health centers in the United States. We are the institutions
which conduct a significant portion of the extramural biomedical and
behavioral research funded through the National Institutes of Health,
and I welcome this opportunity to comment on the programs and policies
which seek to strengthen the nation's extramural research enterprise.
First, I would like to thank all of the Members of this
Subcommittee for the outstanding support provided to the NIH over the
past several years. The additional funds clearly have a significant
impact the causes, prevention and treatment of health problems which
afflict the citizens of our nation and the world.
Second, I would like to thank the Subcommittee for successfully
raising the salary cap imposed on extramural NIH researchers to Level
One of the Executive Pay Scale, or $161,200 per year. This higher
salary level allows academic medical centers to attract and retain the
most talented individuals to biomedical and behavioral research,
especially clinician-investigators. Further, the higher salary cap
assures equity between intramural and extramural scientists. Because of
your leadership, extramural salaries will now be equal to the maximum
salary level which the NIH can pay its own senior scientists under the
Senior Biomedical Research Service.
I would like to take this opportunity to request your support for
further enhancing the extraordinary partnership that was established
with great foresight years ago between academic institutions and the
Federal Government. This partnership has spawned remarkable scientific
developments over decades. These advances position us--academia,
industry, and the government--to work together to exploit the golden
era of biology. Academic institutions across the nation are proud to be
major players in this partnership.
INCREASED FUNDING FOR NIH
As we look ahead to fiscal year 2002, I would like to begin by
expressing the support of academic medical centers, and the extramural
research community, to seek a $3.4 billion or 16.5 percent increase for
the NIH this year to bring the agency's budget to $23.7 billion for
fiscal year 2002. This level of support will keep efforts on track to
double the NIH's budget by fiscal year 2003. This is an incredible time
in biomedical history as the mapping of the human genome has been
successfully completed just last month. This extraordinary
accomplishment presents an exponential number of additional
opportunities to investigate the causes of disease and will lead to new
roads of inquiry to developing cures. In addition--and I will repeat a
statistic that I am sure you are all very aware--the NIH currently
funds fewer than four of every 10 approved research grants. All of
these are judged by peer-review to merit funding because of their
potential for biomedical advance. For these reasons, I urge you to
continue efforts to increase the NIH's budget toward the goal of
doubling the agency's budget by fiscal year 2003.
Having raised the need to continue to increase funding for the NIH,
I would like to bring to your attention several factors that impact the
ability of our institutions to carry out the extramural component of
our nation's expanding and thriving biomedical research enterprise. Our
institutions bear certain costs for conducting NIH research that are
not supported by the federal research dollar. In fact, all
institutions, either public or private, bear a portion of the research
expense. I am here today to advocate that we further strengthen the
academic/federal partnership so that the extramural biomedical and
behavioral research community can operate at optimal capacity and
efficiency: Specifically, I urge you to:
--Increase extramural construction funding so that NIH investigators
can utilize state-of-the-art facilities to carry out the
increasing volume of federally-supported biomedical and
behavioral research; and
--Provide resources to research institutions in order to comply with
the increasing costs of federal regulation.
In addition, I seek your support for increased funding through the
Agency for Healthcare Research and Quality for technological support to
combat medical errors. This problem has been highlighted in a review by
the Institute of Medicine and in numerous media reports.
increase funding for facilities construction, renovation, and equipment
For the past two years, the NIH has included $75 million in
extramural construction funding through the NIH's National Center for
Research Resources (NCRR). These funds are necessary for extramural
researchers to have adequate laboratories in which to conduct this
important research. 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.
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 $11.4 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.'' We have reached a period where the useful life of our
research facilities fail to meet the needs of modern technology and in
many instances do not meet regulatory standards.
While the research community commends the Subcommittee for
providing $75 million for extramural facility construction last year,
there is a clear and documented need for several billion dollars to
rectify this situation. For this reason, we urge the Subcommittee to
provide a funding level of $250 million for extramural construction in
fiscal year 2002. The funds would be awarded on a peer-reviewed,
competitive basis--requiring institutional matching funds to leverage
NIH resources.
INCREASING COSTS OF COMPLYING WITH FEDERAL REGULATIONS
Another issue of significant concern to academic medical centers is
the increased costs to research institutions for complying with
research-related federal regulations. While extramural researchers have
always been subjected to certain federal regulations, the increasing
number of administrative requirements imposed on institutions has
resulted in escalating costs. In recent years, institutions have been
required to take additional measures to comply with more frequent
institutional review boards, privacy regulations, human subject and
animal protections--to name just a few. Let me reiterate that
researchers are not opposed to providing these safeguards and do not
question the necessity of these measures. We are, however, concerned
about the costs of complying with these mandates, many of which are
constantly changing. Last year the nonprofit RAND institute published a
report titled ``Paying for University Research Facilities and
Administration.'' The report notes that compliance costs affect both
facilities and administrative components, and further states
``increasingly sophisticated regulations have required new specialized
personnel.'' The RAND report further provided the following impact on
an unnamed institution:
``. . . compliance with facilities requirements necessitates so
many improvement projects for existing facilities that is infeasible to
undertake them all at once. This university has committed $1.2 million
per year, indefinitely, for facilities improvements to enhance
compliance with hazardous waste, occupational safety, animal care, and
other facilities regulations . . . This is only a partial estimate of
the costs of compliance. This estimate does not include the costs of
compliance associated with major building renewal of new construction
projects that the university undertakes. Neither does it include the
costs of administrative oversight each year to track compliance, train
people, and make reports''.
FASEB, in its recommendations for federal funding for biomedical
and related life sciences funding for fiscal year 2002, specifically
advocates ``that NIH, other federal agencies and the biomedical
research community address growing administrative costs associated with
increased regulation, such as for human subjects protection and animal
care. These costs should be fully funded by the sponsoring agency.''
Researchers at academic medical centers join reiterate the concern
raised by our colleagues in FASEB that federal agencies sponsoring
biomedical and behavioral research should provide adequate funds for
institutions to comply with the necessary regulations associated with
conducting federal research. In my own institution, we have had to add
more than five new staff to meet recently enacted regulations. Our
interaction with federal agencies responsible for these has increased
several-fold.
technological infrastructure to address medical errors
Lastly, I would like to commend the Subcommittee for providing $50
million in last year's Labor/HHS Appropriations bill through the Agency
for Healthcare Research and Quality to determine ways to reduce medical
errors. This funding was provided consistent with S. 2038, the medical
Error Reduction Act of 2000, which was introduced by Senators Arlen
Specter, Tom Harkin and Daniel Inouye. This legislation sought to
establish a competitive demonstration program for health care
facilities and organizations to test best practices for reducing
errors. As institutions with large clinical programs, we are, of
course, interested in reducing the incidents of medical errors within
our institutions. We seek additional funding for this program to
provide our institutions with adequate resources to utilize or upgrade
technological infrastructure to reduce the incidence of medical errors.
CONCLUDING REMARKS
Mr. Chairman, polls conducted by Research!America--including polls
in my State of Ohio--reflect the fact that the American public strongly
supports our federal investments in biomedical and behavioral research.
We believe that NIH's extramural research enterprise would
significantly benefit if institutions were provided with additional
resources, including $250 million to upgrade extramural laboratory
space and instrumentation, and additional funding to address the
increased administrative costs associated with regulatory compliance.
In addition, we support additional funding through the Agency for
Healthcare Research and Quality for technological infrastructure so
that our institutions can reduce medical errors.
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 Academy of Family Physicians
The 93,000 member American Academy of Family Physicians is pleased
to submit this statement for the record on three issues of critical
importance to family physicians in the United States: (1) funding for
family medicine training in Section 747 of the Public Health Service
Act; (2) funding for the Agency for Healthcare Research and Quality
(AHRQ); and (3) funding for rural health programs. The Academy is the
professional organization representing practicing family physicians,
residents and medical students.
FAMILY MEDICINE TRAINING PROGRAMS
Recommendation
The American Academy of Family Physicians supports appropriations
of $158 million for Section 747 of Title VII of the Public Health
Service Act for fiscal year 2002. Section 747 authorizes the Primary
Care and Dentistry cluster, which includes support for family medicine,
general internal medicine and general pediatrics, physician assistants
and general and pediatric dentistry. This figure includes $96 million
for family medicine programs. In fiscal year 2001, Section 747 received
$91 million, a 17 percent increase over last year's funding level of
$78.3 million.
Section 747 is the only program at the federal level that supports
four family medicine training programs at both the undergraduate and
graduate level: residency training; academic departments; predoctoral
programs and faculty development. Section 747 is crucial to training
the physicians that America needs most; it is the engine that powers
the growth of this nation's supply of family physicians.
Title VII Grants to Medical Schools Induces Physicians to go into
Primary Care
A recent, unpublished study by the Robert Graham Policy Center for
Policy Studies showed that the receipt of Section 747 family medicine
funds by a medical school made a significant difference on whether
medical students ultimately (1) practiced in family medicine or primary
care (defined as family physicians, general practitioners, general
internists or general pediatricians), (2) practiced in a rural area, or
(3) practiced in a whole county primary care health professions
shortage area.
--All three types of grants (departments of family medicine,
predoctoral medical education programs, and faculty development
programs) made a difference in producing more family
physicians, and more primary care doctors.
--Predoctoral and department development grants made a difference in
producing more primary care doctors serving in rural areas, and
more primary care doctors serving in primary care health
professional shortage areas.
--Sustained funding during the years of medical school training had
more positive impact than intermittent funding.
Due to Section 747 funding, thousands of physicians are making
career choices to go into primary care and family medicine and to serve
millions of patients. Without Section 747 funding, fewer students would
be making these career choices.
The United States Relies on Family Physicians Unlike any other
Physicians
Another recent study by the Robert Graham Center showed that the
United States relies on family physicians more than any other physician
specialty. Specifically, the study looked at counties designated as
Primary Care Health Professions Shortage Areas, those counties that
have inadequate numbers of family physicians, general pediatricians,
general internists or obstetrician/gynecologists. Currently, there are
3,082 counties in the United States; 784 qualify as Primary Care HPSAs.
The study found that:
--If family physicians were to be withdrawn from all 3,082 counties,
an additional 1,332 counties would become Primary Care HPSAs.
--In contrast, if all internists, pediatricians and obstetrician-
gynecologists were to be taken out of the nation's counties,
only another 176 would become shortage areas.
Without family physicians, counties around the United States would
not receive essential primary care services.
Turning Around the Shortage of Family Physicians
There is a shortage of family physicians and other primary care
physicians (general internists and general pediatricians) in the United
States. Numerous experts, including the Physician Payment Review
Commission; the Council on Graduate Medical Education; the Robert Wood
Johnson Foundation; the Pew Health Professions Commission; the American
Medical Association and the Association of American Medical Colleges
have called for increasing the supply of primary care physicians for
quality, access and cost reasons. Most experts believe a physician
workforce with a 50/50 ratio between primary care physicians and
subspecialists would best meet America's health care needs; the ratio
is currently approximately 30/70.
Section 747 family medicine grants have helped establish an
infrastructure throughout the country that has reversed the downward
trend in primary care. While at one time, the United States physician
workforce was comprised of more than 50 percent primary care
physicians, it declined after World War II to approximately 30 percent
today. The Section 747 family medicine training programs provided funds
to establish family medicine departments in medical schools; to
increase the number of faculty to both teach and act as role models,
and to set up new residencies throughout the country.
Market Demand for More Family Physicians
The demand for family physicians in the market is greater than our
nation's current training capacity. Medicare payment policies have
contributed to the increase in subspecialist physicians and have
fundamentally skewed the market. These policies have promoted training
in the expensive inpatient specialties--rather than in family medicine
and other primary care fields. Moreover, NIH grants, totaling billions
of dollars, go primarily to subspecialist research in the nation's
medical education complexes.
Primary Care Doctors are Cost Effective
Numerous studies show that primary care physicians are more cost-
effective due to their prudent use of hospital services, tests and
procedures. A September, 1995, study conducted by KPMG Peat Marwick,
The Role of Primary Care Physicians in Controlling Health Care Costs:
Evidence and Effects, indicated that Medicare spending could be cut by
at least $48.9 billion and as much as $271.5 billion over the next six
years if primary care physicians were 50 percent of the total physician
workforce.
Community Training Requires Support
In contrast to other specialties, 80 percent of family practice
residencies are located in community settings rather than in major
tertiary care teaching hospitals. These residencies provide more
ambulatory training than any other residencies. As a result, family
practice programs do not have access to the considerable resources that
flow to teaching hospitals. Further, 25 percent of family practice
residencies are located in public hospitals. These hospitals receive a
low reimbursement for patient care services, and treat fewer Medicare
patients. As a result, they do not receive substantial Medicare
graduate medical education dollars.
Acute Shortage of Faculty
There is an acute shortage of faculty for family medicine residency
programs and family medicine departments. The discipline has been
successful at placing its graduates in practice settings serving
communities of need rather than in full-time faculty positions. Without
adequate funding, there is a risk that even the progress that has been
made so far will be compromised for lack of faculty.
Title VII and Graduate Medical Education
Title VII health professions programs are separate and distinct
from graduate medical education (GME). Title VII is a Public Health
Service program and funding goes to medical schools, universities and
residency programs to develop a primary care infrastructure. Graduate
medical education is part of the Medicare program and funds go
primarily to hospitals to support residency training.
The Academy has had a long-standing interest in graduate medical
education because of our commitment to a rational physician workforce
policy that both discourages an oversupply of physicians and encourages
increased training of those physician specialties in short supply. Our
organization has produced and updated a number of policies on physician
workforce issues, as well as specific GME recommendations. However,
without a major overhaul of the physician workforce in the United
States that would address the primary care issues targeted by Title VII
funding, it is imperative to support these programs.
Innovative Programs
Title VII funds are used to support innovative new programs that
help training and teaching programs simply get better, a goal that
often involves new technologies. Innovative programs can include web-
based technologies to evaluate training programs, or even establish
links to primary care research networks. Grant recipients are using
Title VII dollars to leverage dollars not only to meet the traditional
goals of diversity, outreach to the underserved and rural populations,
but also to new programs that use key technologies.
Additional Outcomes Data
There have been several articles that have specifically described
the value of Title VII family medicine programs.
--An October, 1994 General Accounting Office (GAO) report indicated
that ``students who attended medical schools with family
medicine departments were 57 percent more likely to pursue all
three primary care disciplines (italics added).'' In addition,
the 1994 GAO report indicated that ``students who attended
schools requiring a third-year family practice clerkship were
18 percent more likely to pursue primary care.''
--A November/December, 1997, article in the Archives of Family
Medicine found a strong relationship between continued Title
VII funding and the presence of family medicine departments,
which is associated with greater rates of primary care
production. (The Impact of Title VII Departmental and
Predoctoral Support on the Production of Generalist Physicians
in Private Medical Schools, Robert M. Politzer, ScD, et. al.)
--Family physicians have deep roots in rural communities, where 25
percent of all Americans live. About one-quarter of family
physicians locate there, as well. The February, 1998, Tenth
Report of the Council on Graduate Medical Education (COGME)
stated that, ``Programs authorized under Title VII of the
Public Health Service Act support family medicine programs with
a successful record of training physicians who choose to
practice in rural and underserved areas. These efforts should
be continued and increased.''
The goals stipulated by Congress in the Title VII reauthorization
bill emphasize both the delivery of health services to underserved
populations and the geographic distribution of health professionals to
underserved, particularly rural, areas. These congressionally mandated
goals are fully addressed by the Title VII programs, and for family
medicine, all four program areas have been extremely successful.
In addition, another Congressional priority is to enhance the
diversity of our medical workforce. In 1978, the first year for which
we have data, the number of minority residents in training in family
practice residency programs was 9.5 percent. By 1997, that rate had
increased to 24 percent.
Finally, over 90 percent of physicians who complete family practice
residency programs work in direct primary patient care and are able to
handle a high percentage of their patient's problems.
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
Recommendation
The American Academy of Family Physicians recommends appropriations
of $400 million for the Agency for Healthcare Research and Quality
(ARHQ) in fiscal year 2002. We strongly support the Agency because of
its emphasis on primary care and practice-oriented research. It is the
only federal agency with this charge. In fiscal year 2001, the Agency
for Healthcare Research and Quality (AHRQ), received $269.9 million, a
36 percent increase above the current funding level of $198.76 million.
What is Primary Care Research?
Primary care research includes (1) research on the conditions that
affect the majority of the population, and (2) translating biomedical
research into practice.
Additional research is needed on conditions that affect most
Americans. Most medical care is provided in outpatient settings.
However, ambulatory medicine is the least researched mode of patient
care. While over 95 percent of all medical conditions have been
evaluated and treated outside of hospitals over the last 30 years,
physicians are educated and trained using research that has been
derived mainly from hospitalized patients, or patients with rare
conditions. Primary care physicians who diagnose and treat patients
before they need hospital care operate without the level of research
available to their subspecialist colleagues.
It is not enough to develop new treatments; they must also be
implemented and result in better patient outcomes. American medicine is
praised worldwide for its excellence in biomedical research. However,
while we have invested heavily in new technologies, drugs and
procedures, they are seen increasingly as costly advances for
potentially modest gains. Greater gains may be possible if we can
invest more heavily in finding ways to bring state-of-the art medicine
to community medical practices.
Primary Care Research Agenda
A primary care research agenda should include at least six basic
categories for study. (The agenda is further described in the AHRQ
report, Putting Research into Practice: Report of the Task Force on
Building Capacity in Primary Care, 1993.) Included in this agenda
should be research on:
--the origin of disease and the loss of health;
--improvements in diagnostic accuracy;
--appropriate treatments;
--improvements in the physician-patient relationship;
--improvements in health care delivery;
--improvements in patient satisfaction.
Examples of Primary Care Research Needs
Primary care research is needed to provide information to
physicians on the most effective treatment plans for patients with
numerous, serious conditions. An example of this situation is a single
patient with diabetes, hypertension, depression, low back pain and
heart disease. Traditional, disease-specific treatment is not useful in
this situation; treatment for one disease may exacerbate the other
conditions.
Research is also needed on differentiating the common headache that
affects 20 million Americans from one with serious implications. While
headaches afflict millions of individuals, the primary care physician
has little information on how to identify the few who suffer from life-
threatening illness.
IOM Recommendation on Funding Needed for Primary Care Research
According to the 1996 Institute of Medicine (IOM) report on primary
care, Primary Care: America's Health in a New Era, federal investments
in primary care research today total between $15 and $20 million
annually. The IOM report recommended an immediate fourfold increase in
primary care research.
RURAL HEALTH PROGRAMS
Finally, the Academy supports continued funding for several rural
health programs. In particular, we support the programs of the Federal
Office of Rural Health Policy; Area Health Education Centers, two
programs that are equally important to health care in rural areas and
in our inner cities; the Community and Migrant Health Center Program
and the National Health Services Corps. State rural health offices,
funded through the National Health Services Corps budget, help States
implement such programs so that they benefit rural residents as much as
urban dwellers. Continued funding for these rural programs is vital if
we wish to provide adequate health care services to America's rural
citizens.
CONCLUSION
Thank you for your consideration of these important requests.
______
Prepared Statement of the American Academy of Physician Assistants
On behalf of the 41,000 clinically practicing physician assistants
in the United States, the American Academy of Physician Assistants is
pleased to submit comments on fiscal year 2002 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 $44.285 billion for the Public Health Service in fiscal
year 2002. The Academy is also a member of the Health Professions and
Nursing Coalition (HPNEC) and supports the HPNEC recommendation to
provide at least $440 million to support the Titles VII and VIII
programs in fiscal year 2002. The Academy believes that the recommended
increase in funding for the Title VII health professions programs is
well justified. The programs are essential to the development and
training of primary health care professionals and contribute to the
nation's overall efforts to increase access to care by promoting health
care delivery in medically underserved communities.
The Academy is very concerned with the Administration's proposal to
reduce fiscal year 2002 funding for the Titles VII and VIII programs.
As Members of the Subcommittee are aware, these programs are designed
to help meet the health care delivery needs of the nation's Health
Professional Shortage Areas (HPSAs). By definition, the nation's 2,800
HPSAs experience shortages in the primary care workforce that the
market alone can't address. We wish to thank the Members of this
Subcommittee for your historical role in supporting funding for the
health professions programs, and we hope that we can count on your
support for these important programs in fiscal year 2002.
OVERVIEW OF PHYSICIAN ASSISTANT (PA) EDUCATION
PA programs provide students with a primary care education that
prepares them to practice medicine with physician supervision.
Physician assistant programs are located at schools of medicine or
health sciences, universities, teaching hospitals, and the Armed
Services. All PA educational programs are intensive education programs
that are accredited by the Accreditation Review Commission on Education
for the Physician Assistant.
The typical PA program consists of 111 weeks of instruction. The
first phase of the program consists of intensive classroom and
laboratory study, providing students with an in-depth understanding of
the medical sciences. More than 400 hours in classroom and laboratory
instruction are devoted to the basic sciences, with over 70 hours in
pharmacology, more than 149 hours in behavioral sciences, and more than
535 hours of clinical medicine.
The second year of PA education consists of clinical rotations. On
average, students devote more than 2,000 hours or 50-55 weeks to
clinical education, divided between primary care medicine and various
specialties, including family medicine, internal medicine, pediatrics,
obstetrics and gynecology, surgery and surgical specialties, internal
medicine subspecialties, emergency medicine, and psychiatry. During
clinical rotations, PA students work directly under the supervision of
physician preceptors, participating in the full range of patient care
activities, including patient assessment and diagnosis, development of
treatment plans, patient education, and counseling.
Physician assistant education is competency based. After graduation
from an accredited PA program, the physician assistant must pass a
national certifying examination jointly developed by the National Board
of Medical Examiners and the independent National Commission on
Certification of Physician Assistants. To maintain certification, PAs
must log 100 continuing medical education credits over a 2-year cycle
and reregister every 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, physicians may delegate to PAs those
medical duties that are within the physician's scope of practice and
the PA's training and experience, and are allowed by law. Forty-seven
States, the District of Columbia, and Guam authorize physicians to
delegate prescriptive privileges to the PAs they supervise.
PAs are located in almost all health care settings and in every
medical and surgical specialty. 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 2000, an estimated 161 million patient visits
were made to PAs and approximately 202 million medications were
prescribed or recommended by PAs.
critical role of the title vii, public health service act, programs
A growing number of Americans lack access to primary care, either
because they are uninsured, underinsured, or they live in a community
with an inadequate supply or distribution of providers. The growth in
the uninsured U.S. population increased from approximately 32 million
in the early 1990s to over 42 million today. Simultaneously, the number
of medically underserved communities continues to rise, from 1,949 in
1986 to 2,800 today.
The role of the Title VII programs is to alleviate these problems
by supporting access to quality, affordable, and cost-effective care in
areas of our country that are most in need of health care services,
specifically rural and urban underserved communities. This is
accomplished through the support of educational programs that train
more health professionals in fields experiencing shortages, improve the
geographic distribution of health professionals, and increase access to
care in underserved communities.
The Title VII programs are the only federal education programs that
are designed to address the supply and distribution imbalances in the
health professions. Since the establishment of Medicare, the costs of
physician residencies, nurses and some allied health professions
training has been paid through Graduate Medical Education (GME)
funding. However, GME has never been available to support PA education.
More importantly, GME was not intended to generate a supply of
providers who are willing to work in the nation's medically underserved
communities. That is the purpose of the Title VII Public Health Service
Act Programs, which support such initiatives as loans and scholarships
for disadvantaged students, scholarships for students with exceptional
financial need, centers of excellence to recruit and train minority and
disadvantaged students, and interdisciplinary initiatives in geriatric
care and rural health care.
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 8-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. A PA
program in Kansas has used Title VII funds to provide a significant
portion of the training for 500 PA students in remote, medically
underserved communities in the state. 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 48 percent between 1998 and 2008.
Despite the increased demand for PAs, funding has not
proportionately increased for the Title VII programs that are designed
to educate and place physician assistants in underserved communities.
Nor has the Title VII support for PA education kept pace with increases
in the cost of educating PAs. A review of PA program budgets from 1984
through 1999 indicates an average annual increase of 7.2 percent, a
total increase of 173 percent over the past sixteen years; yet, federal
support has remained relatively static. The fiscal year 2001 increase
in appropriations for Title VII's Cluster on Training in Primary Care
Medicine and Dentistry, which includes funding for PA education,
represented the first real increase in funding in nearly a decade.
RECOMMENDATIONS ON FISCAL YEAR 2002 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 2002. 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 increase in funding for PA education programs that
was appropriated for fiscal year 2001. Yet, the increase is not
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 receive a 15 percent funding increase in fiscal year 2002,
including $10 million to support PA educational programs.
Thank you for the opportunity to present the American Academy of
Physician Assistants' views on fiscal year 2002 appropriations.
______
Prepared Statement of the American Association for Geriatric Psychiatry
The American Association for Geriatric Psychiatry (AAGP)
appreciates this opportunity to present its recommendations on issues
related to fiscal year 2002 appropriations for mental health research
and services. AAGP is a professional membership organization dedicated
to promoting the mental health and well being of older Americans and
improving the care of those with late-life mental disorders. AAGP's
membership consists of over 2000 geriatric psychiatrists as well as
other health professionals who focus on the mental health problems
faced by senior citizens.
AAGP would like to thank the Subcommittee for its continued strong
support for increased funding for the National Institutes of Health
(NIH) over the last several years, particularly the additional funding
you have provided for the National Institute of Mental Health (NIMH)
and the National Institute on Aging (NIA). Although we generally agree
with others in the mental health community about the importance of
sustained and adequate Federal funding for mental health research and
treatment, AAGP brings a somewhat unique perspective to these issues
because of the aged patient population served by our members.
There are serious concerns, shared by AAGP and researchers,
clinicians, and consumers that there exists a critical disparity
between appropriations for research, training, and health services and
the projected mental health needs of older Americans. This disparity is
evident in the convergence of several key factors:
--demographic projections inform us that, with the aging of the U.S.
population, there will be an unprecedented increase in burden
of mental illness among aging persons, especially among the
baby boom generation;
--this growth in the proportion of older adults and the prevalence of
mental illness is expected to have a major direct and indirect
impact on general health service use and costs;
--despite the fact that effective treatment exists, the mental health
needs of many older adults remain unmet;
--a major gap exists between research and service delivery; and
--despite recent significant increases in appropriations for support
of research in mental health, the allocation of NIMH and the
Center for Mental Health Services (CMHS) funds for research
that focuses on mental health and aging is disproportionately
low, and woefully inadequate to deal with the impending crisis
of mental health in older Americans.
DEMOGRAPHIC PROJECTIONS AND THE DISPARITY IN RESEARCH FUNDING FOR
MENTAL DISORDERS OF AGING
As shown in Figure 1 (attached), the increase in the number of
people over 65 years of age, combined with the increasing prevalence of
psychiatric problems in that segment of the U.S. population, will
dramatically increase the proportion of older adults with mental health
disorders relative to younger adults. Furthermore, older adults account
for health care costs that are disproportionately greater than their
numbers. This figure also illustrates that the projected proportion of
NIMH funding for aging research (based on current funding trends) is
drastically below what will be needed to address the projected increase
in mental health problems among older persons over the coming decades.
With the ``baby boom'' generation nearing retirement, the number of
older Americans experiencing mental problems is certain to increase in
the future. By the year 2010, there will be approximately 40 million
people in the United States over the age of 65. Over 20 percent of
those people will experience mental disorders. A national crisis in
geriatric mental health care is emerging and has received recent
attention in the medical literature. Action must be taken now to avert
serious problems in the near future. While many forms of mental and
behavioral disorders can occur late in life, they are not an inevitable
part of the aging process, and continued research holds the promise of
improving the mental health and quality of life for older Americans.
Current and projected economic costs of mental disorders alone are
staggering. For example, the direct medical costs of caring for
patients with Alzheimer's disease (many of whom are treated by
geriatric psychiatrists) ranges from $18,000 to $36,000 a year per
patient, depending on the severity of the disease. In addition, there
are other expenses associated with caring for an Alzheimer's disease
patient including social support, care giving, and often nursing home
care. It is estimated that total costs associated with caring for
patients with Alzheimer's disease is over $100 billion per year.
Psychiatric symptoms (including depression, agitation, and psychotic
symptoms affect 30 to 40 percent of people with Alzheimer's and are
associated with increased hospitalization, nursing home placement,
family burden, and over 20 percent greater costs over and above
Alzheimer's alone. Although NIA has supported extensive research on the
cause and treatment of Alzheimer's, treatment of these behavioral and
psychiatric symptoms has been neglected and should be supported through
NIMH.
Depression is another example of a common problem among older
persons. Of the approximately 32 million Americans who have attained
age 65, about five million suffer from depression, resulting in
increased disability, general health care service use and costs, and
increased risk of suicide. Approximately 30 percent of older persons in
primary care settings have significant symptoms of depression; and
depression is associated with greater health care costs, poorer health
outcomes, and increased mortality. Older adults have the highest rate
of suicide rate compared to any other age group.
The enormous and widely underestimated costs of late life mental
illnesses justifies major new investments. The personal and societal
costs of mental illness and addictive disorders are high, but advances
in research and treatment will help save lives, strengthen families,
and save taxpayer dollars. While the funding increases supported by
this Subcommittee in recent years have been essential first steps to a
better future, a serious and sustained investment in research is
necessary to allow continuous progress on the many research advances we
made to date. Toward that end, we support the professional judgment of
the mental health research advocacy community that a 16.5 percent
across-the-board increase in fiscal year 2002 funding for NIH is
warranted.
Commendable as recent funding increases for NIH and NIMH have been,
AAGP would like to call the Subcommittee's attention to the fact that
these increases have not always translated into comparable increases in
funding for extramural research on mental health of the elderly. Data
supplied to AAGP by NIMH indicates that while extramural research
grants by NIMH increased 59 percent during the 5-year period from
fiscal year 1995 through fiscal year 2000 (from $485,140,000 in fiscal
year 1995 to $771,765,000 in fiscal year 2000), NIMH grants for aging
research increased at less than half that rate: only 27.2 percent
during the same period (from $46,989,000 to $59,771,000).
Figure 2 (attached) shows that funding for aging mental health
research is not keeping pace with that of other adult mental health
research, and is actually decreasing proportionally when considered in
the context of anticipated projections in growth of mental disorders in
older persons. For example, the proportion of total NIMH newly funded
extramural research grant funding devoted to aging research declined
from an average of eight percent from fiscal years 1995 to 1999 to a
low of six percent in fiscal year 2000. It is likely that one reason
for the decline in funding of new grants is due to the lack of grant
review committees at NIMH with specific expertise in aging. Grant
review committees with specialized expertise in geriatrics are needed
to assure fair review of research proposals that take into account
knowledge of the unique biological factors associated with the aging
brain, the universal presence of co-occurring medical disorders, and
different nature of financing and health service delivery for older
Americans.
THE BENEFITS OF RESEARCH ON PUBLIC HEALTH
The U.S. Surgeon General's Report on Mental Health (1999) and the
Administration on Aging Report on Older Adults and Mental Health (2001)
underscore the prevalence of mental disorders in older persons and
provide evidence that research supports the development of effective
treatments. These publications by the Federal Government recognize the
increasing importance of late life mental illness on our society. In
addition, these reports summarize research findings showing that
treatments are being developed and tested that are effective in
relieving symptoms, improving functioning, enhancing quality of life,
including preliminary findings suggesting that these interventions
reduce the need for expensive and intensive acute and long-term
services. However, it is also well demonstrated that there is a
pronounced gap between research findings on the most effective
treatment interventions and implementation by health care providers.
These reports stress the need for translational and health services
research focusing on identifying the most cost-effective interventions,
as well as creating effective methods for improving the quality of
health care practice in usual care settings. A major priority
(neglected to date) is the development of a research agenda focusing on
health services research on mental health and aging that examines the
effectiveness and costs of effective models of mental health service
delivery for older persons.
Special attention also needs to be paid to investigations of
inadequate, or poorly studied, serious late-life mental disorders since
illnesses such as schizophrenia, anxiety disorders, alcohol dependence
and personality disorders have been largely ignored by both the
research community and the funding agencies despite the fact that these
conditions take a major toll on patients, their care givers, and
society at large. Many of AAGP's members are at the forefront of
groundbreaking research on Alzheimer's disease, depression, and
psychosis among the elderly, and we strongly believe that more research
funds must be focused in these areas. Improving the treatment of late-
life mental health problems will benefit not only the elderly, but also
their children, whose lives are often profoundly affected by those of
their parents.
Perhaps one of the greatest costs of late-life mental illness is
the physical and emotional toll on family members, caregivers, and
friends. AAGP would like to express its appreciation to Congress for a
new program established and funded for the first time this year: the
Family Care Givers Program of the Older Americans Act. This new program
provides funding to the States so that they may assist family care
givers in obtaining the best, most appropriate care for their loved
ones, as well as offering care givers limited, but badly needed respite
from their care-giving responsibilities. First year funding of
$125,000,000 was authorized and appropriated for fiscal year 2001. AAGP
expects the need for these services to grow rapidly in the future and
urges the members of the Subcommittee to be responsive to this need as
it develops. In addition to caregiver programs and support services,
research is needed to fill in the gaps in our understanding of the
psychiatric responses of caregivers to the chronic stresses of taking
care of older adults with mental illnesses.
In addition to supporting research activities at the NIMH, AAGP
supports increased funding for the other institutes at the NIH that
have some jurisdiction over geriatric mental health, including the NIA
and the National Institute of Neurological Disorders and Stroke.
It is also critical that there be adequate funding increases for
the mental health initiatives under the jurisdiction of the CMHS within
the Substance Abuse and Mental Health Services Administration (SAMHSA).
While research is of critical importance to a better future, the
patients of today must also receive appropriate treatment for their
mental health problems. SAMHSA provides funding to State and local
mental health departments, which in turn provide community-based mental
health services to Americans of all ages, without regard to the ability
to pay. The Labor-HHS conference agreement for fiscal year 2001
increased funding for SAMHSA by about 11.5 percent (from $2,651,342,000
to $2,958,001). AAGP urges the Subcommittee to increase the funds
available to SAMHSA for these purposes to keep pace with this demand.
Furthermore, a top priority should be funding for the dissemination
and implementation of evidence-based practices in ``real world'' usual
care settings. Despite significant advances in research on the causes
and treatment of mental disorders in older persons, there is a major
gap between these research advances and clinical practice in usual care
settings. The greatest challenge for the future of mental health care
for older Americans is to bridge this gap between established research
findings and clinical practice in the community. A specific geriatric
mental health services initiative is needed to disseminate and
implement evidence-based practices in routine clinical settings across
the states.
CONCLUSION
Based on AAGP's assessment of the current need and future
challenges of late life mental disorders, we submit the following
recommendations:
--The current rate of funding for aging grants at NIMH and CMHS is
inadequate. Funding for NIMH and CMHS aging research grants
should be increased to be commensurate with current need
(approximately three times the current funding level). In
addition, the anticipated projected future increase in mental
disorders among our aging population in terms of dollar amount
of grants and absolute number of new grants should be built
into the budget process;
--A fair grant review process will be enhanced by committees with
specific expertise and dedication to mental health and aging;
and
--Infrastructure within NIMH and CMHS is needed that supports the
development of initiatives in aging research, monitors the
quality and number of applicants for aging research grants, and
management of those grants. Specifically, AAGP believes that
individuals should be designated in the Office of the Director
of NIMH and in the Office of the Director of CMHS to oversee
the aging research agendas and initiatives for these two
agencies.
AAGP strongly believes that the present research infrastructure,
health care financing, and healthcare personnel with appropriate
geriatric training, and the mental health delivery systems are grossly
inadequate to meet the challenges posed by the expected increase in the
number of elderly with mental disorders. The economic impact of the
aging baby boom generation on the Medicare and Social Security systems
has already become a focus of national dialogue, but that there is
another challenge that has not received attention. Because of reduced
mortality in older adults with chronic medical disorders, we can expect
an unprecedented explosion in the number of people over age 65 with
potentially disabling chronic mental illnesses. Congress must continue
to support funding for research that addresses the identification,
diagnosis, and treatment of mental illnesses, as well as support
programs that increase the quality of life for those with late life
mental illness.
The American Association for Geriatric Psychiatry looks forward to
working with the members of this Subcommittee and others in Congress to
establish aging research as a priority at NIMH and at CMHS.
______
Prepared Statement of the American Association of Immunologists
The American Association of Immunologists (AAI) is a professional
association of six thousand research scientists and physicians
dedicated to understanding the immune system, resulting in the
prevention, treatment, and cure of disease. We appreciate this
opportunity to submit written testimony for the Hearing Record
regarding the fiscal year 2002 appropriations bill for the Departments
of Labor, Health and Human Services, and Education. Our comments will
be confined to issues involving the Department of Health and Human
Services, and specifically, the National Institutes of Health (NIH).
fiscal year 2002 appropriations for the national institutes of health
AAI is grateful for this subcommittee's and the Congress's strong
commitment to biomedical research through the ongoing effort to double
the budget of the National Institutes of Health. In addition to the
sheer purchasing power of the increased appropriations--allowing for
the funding of more quality research grants, better lab equipment, and
training for the next generation of scientists--this national
commitment has energized researchers around the world who realize that
many of the scientific achievements and discoveries of recent years--
including the sequencing of the human genome--are just the first
essential steps toward unraveling the mysteries of the human body and
the treatments that may prevent or even cure deadly diseases. We urge
this subcommittee, therefore, to support rapidly unfolding biological
discoveries by continuing the process of doubling the NIH budget with
additional appropriations of $3.4 billion for fiscal year 2002, for a
total budget of $23.7 billion.
IMMUNOLOGY AND ITS PROMISING RESEARCH
While ``immunology'' may not be a discipline that Americans
contemplate in their daily lives, AAI's members' life's work affects
every person throughout the world every day. Immunologists study both
the immune system that helps protect the body from harm and the
maladies--from the common cold or flu to cancer and AIDS--which can
invade it. Many of us work to discover the cause of a particular immune
response--which can range from successfully destroying an invading
virus or bacteria to fighting one's own body tissues (resulting in an
``autoimmune'' response and possibly causing an autoimmune disease).
Others work to find a way to prevent an undesirable immune response,
i.e., an allergic response to a vaccine or drug treatment. And others
of us work to find a treatment for a known immune response that leads
to illness or disease (such as diabetes). So when you read the
newspaper and see stories about scientists working to develop effective
vaccines for HIV/AIDS and influenza; to discover new defenses against
re-emerging infections such as tuberculosis and drug-resistant
bacterial infections; to regulate autoimmune diseases such as diabetes
and lupus; to develop treatments to prevent the rejection of
transplanted organs and bone marrow; and to discover the causes of
cancer and promising new treatments, you are reading about immunology
and the budget of the National Institutes of Health.
To give you an example of the type of research conducted by
immunologists, let us cite a few examples of some exciting work now
being done.
--On March 9, 2001, the Washington Post reported on a new study by
immunologists that supports the prospect of an AIDS vaccine.
According to the article, ``[i]n a study offering new evidence
that AIDS can be controlled by vaccine, inoculated monkeys
stayed healthy despite exposure to high levels of virus. . . .
The new vaccine is being fast-tracked toward human testing.''
The study was reported in the March 9 issue of the journal
Science.
--Immunologists are studying responses of the fortunate few people
who are repeatedly exposed to HIV but don't get the virus, to
determine how their immune system appears to fend off active
infection of HIV-crucial information for the design of an
effective vaccine.
--Immunologists are also working at understanding how the immune
system can recognize cells infected with viruses. Here mice,
genetically modified to have only a very simple immune system--
but one which can recognize a lethal virus infection--are
critical to understanding how an immune response is initiated,
how the immune system remembers past infection, and therefore
how it will respond to future infection. These studies,
originally made for a virus infection in mice, have led to
clinical trials in cancer immunotherapy (see Time Magazine,
January 15, 2001).
--Immunologists are studying the role of cytokines (hormone-like
substances made by cells that regulate immune and other
biological functions) in mice to discover their role in
protecting their hosts from intestinal parasites such as worms
and also to determine their deleterious role in asthma,
allergy, rheumatoid arthritis, and lupus. This research might
help determine the best way to reduce or prevent the
overproduction of cytokines, to prevent these diseases, and to
identify and reduce side effects from potential treatments.
Earlier research by this same team of scientists helped to
determine that cytokines play a critical role in causing
asthma.
--Immunologists are studying how cytokines affect the immune response
to self-antigens (molecules already in the body) in the insulin
secreting cells in the pancreas. Understanding the immune
response is critical because we know that autoimmune
destruction of the pancreas is the cause of Type I diabetes, a
disease which classically attacks young people. A recent paper
has shown that by changing the way the self-antigen is exposed
to the immune system, the disease can be prevented in mice
genetically predisposed to develop diabetes.
--Immunologists are studying periodontal disease (gum disease), which
is the major cause of tooth loss in the United States. Current
work is seeking to understand how the two major bacterial
species cause this disease. This involves cloning the bacterial
genes necessary for allowing the bacteria to cause disease, and
understanding the body's response to the bacteria. Both the
bacteria and the response are necessary to cause tooth loss.
--Immunologists are studying the effect of aging and environmental
factors on the development of autoimmune disorders, with a
special focus on myasthenia gravis--a disease that causes
muscle weakness. In this disease, the immune system responds to
a critical molecule necessary for nerve signal conduction.
Because this molecule is present only in very low amounts,
people (and animals) are able to develop an immune response
since immune tolerance was never produced. Immunologists have
created a transgenic mouse in which this tolerance does occur.
This allows the identification of the major mechanisms of
disease to be discovered and ultimately controlled.
--Immunologists have identified a novel DNA binding protein that is
produced only in the thymus and appears to play a role the
production of the antigen receptor gene rearrangement. Because
aberrant rearrangement of certain genes (oncogenes) has been
seen in many lymphomas and leukemias, immunologists are
studying the regulatory processes involved. Such studies may
offer critical insight into both diseases.
--Immunologists are studying systemic lupus erythematosus (lupus), an
autoimmune rheumatic disorder which can cause arthritis,
rashes, kidney failure, central nervous system disease, and
other serious medical problems. In studying the antibodies that
are made in the disease and the substances to which they bind,
a team of immunologists has theorized that the Epstein Barr
virus may play a role in causing this disease and is now
testing this theory. These immunologists are also working to
identify the genes which they believe may predispose people to
develop lupus.
As the above examples show, the work of immunologists is varied and
relevant to the everyday lives of many American families. Our members
devote their professional lives to painstaking work that may one day
cure a disease or contribute on some smaller but significant level to
better scientific understanding of complex human physiological
reaction.
MAKING SCARCE DOLLARS GO FURTHER
As this subcommittee struggles with difficult decisions regarding
the funding level for NIH and other important government agencies and
programs for fiscal year 2002, we would like to suggest two ways that
we believe that dollars allocated to biomedical research could be
stretched further. First, our researchers have found an increasing
regulatory burden placed on them by various rules and regulations
promulgated by a variety of government agencies. While our scientists
appreciate that their work is funded by taxpayer dollars and respect
their duty to account for the use of those funds, they have often found
these regulations burdensome and lacking any measurable benefit, taking
valuable time (and money) away from the research at hand.
Reducing paperwork and streamlining and simplifying rules would
certainly help obtain the greatest value from every research dollar.
Second, as our work described above makes clear, immunologists
depend heavily on the use of animal models in their research. Without
the use of animals, theories about immune system function and
treatments that might cure or prevent disease would have to be tested
first on human subjects, something our society--and our scientists--
would never countenance. Despite the clear necessity for animal
research, people and organizations that oppose such research are
threatening scientists who use animal models. The legal and extra-legal
methods used by these groups to further an animal-rights/anti-medical
research agenda is diverting precious resources from our work,
threatening the personal safety and security of scientists, and
delaying the progress of important research that is already underway.
Addressing this ongoing problem is an additional cost that--were it
relieved--would enable NIH dollars to go further.
NIH BUDGET PLANS FOR SUPPORTING YOUNG SCIENTISTS
AAI would like to call to the subcommittee's attention NIH's
announced plans to increase the level of stipends for post-doctoral
recipients. AAI has been deeply concerned about the future supply of
biomedical researchers, and in particular, the plight of post-doctoral
fellows who are significantly underpaid and under-compensated for their
work. In early March, the National Academy of Sciences (NAS) held a
Convocation on Enhancing the Postdoctoral Experience For Scientists and
Engineers to discuss post-doctoral issues and a report recently issued
by its Committee on Science, Engineering, and Public Policy (COSEPUP).
Among the many recommendations of the COSEPUP committee was the need
for better compensation and employment benefits for post-doctoral
fellows. NIH responded by releasing on March 22 a statement in response
to the NAS report (Notice NOT-OD-01-027), in which it indicates its
plans to increase the stipends for National Research Service Award
(NRSA) recipients over a period of five years. While AAI believes that
the urgency of the situation requires a phase-in of higher stipends and
the offering of basic employment benefits in considerably less than
five years, AAI applauds NIH for responding to the COSEPUP report
promptly and greatly appreciates NIH's leadership in beginning to
address the need for better compensation for post-doctoral fellows. We
urge this subcommittee and the Congress to support efforts to address
the immediate need for better compensation and benefits for our
nation's future biomedical research leaders.
NIH BUDGET ON RESEARCH MANAGEMENT AND SUPPORT (RMS) FUNDING
Current funding for management and oversight at NIH is $693
million, or 3.3 percent of the NIH budget. As funding for NIH has
increased, allowing for large new numbers of increasingly complex
grants, there has been an inadequate increase in support for oversight
to ensure that the funds are used wisely and well. As Congress has
increasingly asked questions--rightfully so--about what NIH and the
nation's researchers are doing with these additional funds, NIH is
hampered by insufficient staff to either answer those questions or to
ensure fully the proper management and oversight of existing grants.
Between 1984 and 2000, there was little if any increase in RMS
funding. In fiscal year 2000 and fiscal year 2001, there were increases
of 8 percent and 10 percent respectively, raising the RMS to its
current level. But if NIH is to properly manage taxpayer dollars,
ensure the continuation of its excellent and highly regarded peer
review process, provide professional development to staff, manage its
facilities, provide public education, and undertake the multitude of
activities supported by the RMS budget, AAI believes that an increase
in the RMS budget to 4.5 percent of the NIH budget--a level that is the
historical average--is required. We urge this subcommittee to review
this important budget category again this year, recognizing that for
NIH to use well--and account for--the generous funding increases you
have provided, the RMS budget needs your active support.
On behalf of AAI, may I express our appreciation for having this
opportunity to submit our remarks and invite any members of the
subcommittee who have questions to feel free to contact me for further
information.
______
Prepared Statement of the American Association of Colleges of Nursing
The American Association of Colleges of Nursing (AACN) respectfully
submits this testimony to the Subcommittee with our requested funding
priorities for nursing research and education programs. This federal
support will be a critical piece in the nation's effort to overcome the
nursing shortage. AACN represents over 550 baccalaureate and graduate
nursing education programs in senior colleges and universities across
the United States.
The country is in the midst of an emerging nursing shortage unlike
any that the nation has experienced over the past 30 years. Since 1994,
AACN has noted declining enrollments in baccalaureate nursing programs.
Increasingly, employers are reporting dramatic and crisis level
shortages of nurses in their health care settings. Hospitals are forced
to close entire patient care units; ambulances are being diverted to
other overcrowded facilities; and surgeries are being canceled due to
the lack of appropriately educated and skilled registered nurses (RNs).
Nurse vacancy rates are noted in all practice settings including long-
term care, home care, and public health. In addition, an aging
workforce, with the average age of RNs up to 45.2 years, compounds the
shortage.
Although employers are seeking a more highly educated nursing
workforce for today's complex health care environment, only 41 percent
of nurses have a baccalaureate or higher degree. The growing shortage
and the decline in enrollments are accompanied by a number of other
factors that will affect the ability of the nursing profession to meet
the demand for professional nursing care. The longitudinal American
Freshman Study indicates that an extremely small percentage of freshman
college students are choosing a nursing career. A recent national
assessment of children's career aspirations by the J. W. Thompson
Company has found that young children, particularly those who plan to
seek a college education, also do not see nursing as an attractive
career option.
A lack of nursing faculty has had an impact on the shortage. The
majority of AACN member nursing programs report great difficulty
filling budgeted faculty positions. The small one percent of doctorally
prepared nurses in this country and the lengthy completion time of a
doctoral degree have limited the availability of nurses prepared to
function in a faculty role. Doctoral nursing students also are more
often part-time students and have maintained their full-time clinical
or other positions. Expansion of doctoral enrollments as full-time
students would facilitate greatly the production of available faculty.
AACN members also report difficulty recruiting master's prepared
nursing personnel for faculty roles because of the great disparity
between clinical salaries and the salaries available as a faculty
member. Schools would benefit from support initiatives that provide
resources to augment salaries for specialized faculty needed to support
the entire program.
AACN recognizes that strategies to meet the growing nursing
shortage must encompass private and public sector initiatives. Local
communities and health care employers are utilizing creative programs
to recruit middle school students into the nursing profession. States
are introducing legislation funding scholarships and studies to assess
statewide workforce need. We are asking the Subcommittee to graciously
consider these requests and the effect that an unresolved RN shortage
of this magnitude will have on the future of health care in America.
NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)
We thank you and respectfully request a fiscal year 2002 funding
level of $144.37 million, which reflects an increase of $40 million for
the National Institute of Nursing Research. At this funding level, NINR
will support significant new research on health disparities in diseases
such as diabetes and cardiovascular disease, self management of chronic
pain, end-of-life research to address weight loss, muscle wasting,
fatigue, and caregiver issues. Most critical to enhancing research
within the nursing profession is infrastructure development that
increases the pool of nurse investigators, expands programs to develop
partnerships between research-intensive environments and smaller
colleges and universities, and promotes career development for minority
researchers.
In an effort to develop the pool of nurse faculty and researchers,
NINR directs 8 percent of its budget to research training. Research
training dollars supported approximately 190 pre-doctoral nurse
researchers and 70 post-doctoral researchers this year. These numbers
must be increased in the future to address recent recommendations of
the National Research Council. Additionally, AACN's 2000 Survey of
Institutional Data Systems claims 3,338 nurses in doctoral programs,
indicating that NINR supports less than 6 percent of those nurses in
doctoral study. In view of the national nurse faculty shortage of 500
unfilled positions in teaching and research, we recommend this
significant increase in appropriations for additional stipends and
training for pre- and post-doctoral researchers.
NINR provides research findings for the nation's largest profession
of health care providers: 2.7 million RNs. In light of the increasing
shortage of qualified professional nurses, the NINR requires a
significant funding increase for the following reasons:
--To provide clinically-based research findings that make a
difference in the lives of all Americans, from our youth whose
health needs must be addressed to our nation's aging population
of which many experience chronic, debilitating diseases.
--To establish the role of nurse researcher, which attracts bright
young women and men into a field that provides opportunities to
both conduct meaningful research and use important research
findings that make a difference in people's lives.
NINR's fiscal year 2001 funding is at $104.37 million. This is
$14.83 million or 16.6 percent more than the fiscal year 2000 level.
Nurses from across the nation are thankful for this increase. It has
provided resources for 81 new multi-year research grants beginning in
fiscal year 2000 and an estimated 60 new studies, which begin in fiscal
year 2001.
The increase in appropriation for fiscal year 2000 enabled NINR's
success rate to reach the NIH mean success rate of 32 percent for
competing research projects for the first time in its 15-year history.
This is a significant improvement over fiscal year 1999 when the
success rate was only 14.4 percent. Because of NINR's ability to
attract important applications for research studies, the success rate
for fiscal year 2001, despite a good increase in appropriation, is
estimated to be only 20 percent.
The fiscal year 2000 research findings from NINR-funded studies
include 17 reports related to aging, long-term care, or Alzheimer's and
care giving. More studies are reported in dozens of scientific articles
in: HIV/AIDS patient care, cardiovascular disease prevention and care,
child and adolescent health, critical care, diabetes, mental health,
and the utilization of nurses in the health care system. In addition,
NINR-funded investigators across the country produced scientific
advances in maternal-infant care, pain and other symptom management,
and women's health. These findings together form the research base to
establish evidence-based practice for registered nurses providing
direct patient care 24-hours a day, seven days a week, all across the
country.
In addition, NINR is the lead institute at NIH to coordinate
research on end-of-life care, addressing the public's disappointment
with the current status of care at the end of life. Other groups such
as the Institute of Medicine, the Robert Wood Johnson Foundation, and
the Hartford Foundation recognizing this need especially in light of
our aging population. End-of-life care utilizes many of the skills of
nurses such as pain and other symptom management, clinical management
to promote quality of life, and family teaching and counseling. This
focus helps families to identify and use resources to better cope with
the stresses at this critical time.
The Subcommittee investment in NINR is well justified as nursing
research contributes extensively to wellness and health choices that
prevent disease. The NINR supports investigators who conduct a broad
range of clinical research, developing and testing interventions to
improve patient care, treat disease, manage chronic conditions and
address the physical and emotional concerns that are important to the
diverse American public. There is growing evidence of advances made
possible by NINR research, but I will highlight just four recent
success stories. AACN believes that based on these and numerous other
examples, it is clear that nursing research is making a difference in
health outcomes. For example, NINR research has made a difference by
identifying interventions or other studies to:
--Enhance the independence and reduce signs of distress among
severely cognitively impaired nursing home residents.
--Develop new methodologies for investigating ways to reduce breast
cancer risk in women who have a genetic predisposition.
--Reduce the extremely high stress levels experienced by family
members who were involved with decisions to stop life-
sustaining support for a terminally ill loved.
--Reduce the risk of cardiovascular disease in children from minority
backgrounds who are living in rural areas.
THE NURSE EDUCATION ACT (NEA)
We also ask for increased funding of $25 million for the Nurse
Education Act and additional funding for the nursing student loan
programs. AACN recommends an increase in the NEA for fiscal year 2002
to $103.1 million for the NEA and $an additional $20 million directed
to student loan programs. NEA appropriations for fiscal year 2001 were
$78.1 million. Central to increasing the availability of a well-trained
nursing workforce is the availability of educational grants and
scholarships. Current demand for nursing student loan support exceeds
significantly the resources available. In addition, scholarship support
is a major incentive to enter the profession and facilitates full-time
study.
Title VIII of the Public Health Service Act (PHSA), the NEA, is the
major federal statute providing authority for the Department of Health
and Human Services to fund initiatives to expand or improve nursing
education. Authorities under Title VIII provide for support of advanced
practice nursing education, special initiatives for nursing clinics,
support of innovations in the delivery of nursing care, expansion of
enrollments in baccalaureate nursing programs, and development of
initiatives to expand minority nursing enrollments. Several of the
programs assist schools with their efforts to bring more students into
baccalaureate nursing programs. In addition, the program for loans to
nursing students allows students to acquire low interest rate loans
that can be repaid through service in high need areas.
--Advanced Education Nursing Grants (Sec. 811).--The initiative
provides grants to schools to train advanced practice primary
care nurse practitioners and nurse midwives. It also provides
grants to educate master's and doctoral students as clinical
nurse specialists, public health nurses, nurse administrators,
faculty, nurse anesthetists, and non-primary care nurse
practitioners. It includes traineeships for master's and
doctoral students with a limit of 10 percent of appropriations
for doctoral traineeships.
--Nursing Workforce Diversity Grants (Sec. 821).--To increase
opportunities for nursing education for disadvantaged students,
including underrepresented minorities, this initiative
furnishes scholarships, stipends, pre-entry preparation, and
retention activities. Grantees are responsible for
accomplishing the objectives of their grants.
--Basic Nurse Education and Practice Grants (Sec. 831).--This
initiative disseminates grants to schools of nursing to
strengthen basic nurse education and practice with seven
priority areas. The areas are: expanding nursing practice in
non-institutional settings to increase access to primary health
care, training for care of underserved and high risk
populations, education for managed care, developing cultural
competency, expanding baccalaureate enrollments, increasing
nursing career mobility, and nursing education in informatics
and use of distance learning.
--Nursing Student Loan Program (NSLP) (Sec. 836).--AACN recommends an
appropriation of at least $10.3 million for the NSLP for fiscal
year 2002. Administered by the Division of Student Assistance,
this program was created to address nursing workforce
shortages. Academic institutions select students enrolled in
nursing programs for participation in the program based on
financial need. The program operates on revolving funds
received through student loan paybacks and returned funding
received from nursing schools that closedown. In fiscal year
2001, only 291 out of 1,500 eligible collegiate schools of
nursing participate in the program because of reluctance to
compete for the limited funding. This loan program has received
no new funding since 1983.
--Nursing Education Loan Repayment Program (NELRP) (Sec. 846).--AACN
requests at least an additional $10 million for this program in
fiscal year 2002. The NELRP, administered by the Bureau of
Primary Health Care, provides loans to registered nurses, nurse
anesthetists, and nurse practitioners in exchange for
practicing in designated Health Profession Shortage Areas. Due
to funding limitations in fiscal year 2000, the Bureau provided
loans of 60 percent of the amount authorized to only 50 percent
of the nurses applying for program participation. The NELRP has
$2 million in fiscal year 2001 funding.
scholarships for disadvantaged students (sds)
AACN recommends that SDS be funded at $55.63 million for fiscal
year 2002, a 25 percent increase. Fiscal year 2001 funding is at $44.5
million. Scholarships for Disadvantaged Students is a PHSA Title VII
Program (Sec .737) that provides funds to disadvantaged and minority
health professions students. The statute directs 16 percent of the
funds appropriated to nursing students. This program is the major
federal scholarship source for undergraduate nursing students and
eliminates or reduces the financial barriers that may prevent these
students from enrolling. The majority of SDS recipients are minority
students.
NATIONAL HEALTH SERVICE CORPS (NHSC)
AACN recommends maintaining the 10 percent set aside and increasing
funds for the NHSC to $300 million. The National Health Service Corps
Scholarship and Loan Repayment programs (PHSA Title III) seek to
attract health professionals to practice in Health Professional
Shortage Areas that lack such providers. Many of those areas are rural,
and have difficulty attracting and retaining caregivers. Nursing has a
10 percent set aside that provides funding for certified nurse
midwives, nurse practitioners, and psychiatric clinical nurses
specialists.
CONCLUSION
In summary, AACN respectfully recommends the following
appropriations for fiscal year 2002:
[In millions of dollars]
Amount
National Institute of Nursing Research............................144.37
Nurse Education Act...............................................103.1
Nursing Student Loan Program...................................... 10.3
Nursing Education Loan Repayment Program.......................... 12
Scholarships for Disadvantaged Students........................... 55.63
National Health Service Corps Scholarship/Loan.................... 300
______
Prepared Statement of the American Association of Colleges of
Osteopathic Medicine
As President of the Philadelphia College of Osteopathic Medicine
and Chairman of the Board of Governors of the American Association of
Colleges of Osteopathic Medicine (AACOM), I am pleased to present the
views of our nineteen colleges on fiscal year 2002 appropriations for
health professions education assistance programs under Titles VII and
VIII of the Public Health Service Act. First, I would like to express
the American Association of Colleges of Osteopathic Medicine's
appreciation for the past efforts of this Subcommittee to maintain a
commitment to health professions education. The Subcommittee's vision
has enabled health professions schools in general and colleges of
osteopathic medicine in particular to address the physician workforce
needs dictated by a rapidly changing health care delivery system.
However, we are not yet able to say we are in a position to
completely meet these workforce needs. ``Healthy People 2010,'' a
document that serves as a blueprint for health care delivery, has
articulated two overarching goals: Increase Quality and Years of
Healthy Life; and Eliminate Health Disparities. To achieve these goals
by 2010, we must begin now to train health professionals who have the
necessary skills and commitment. More than ever, institutions need the
support of Titles VII and VIII programs to develop the kind of
workforce consistent with ``Healthy People 2010.''
At the same time we recognize the responsibility of the
Subcommittee to examine all programs in light of their cost
effectiveness in meeting the health care needs of all Americans. We
believe colleges of osteopathic medicine measure particularly well
under such scrutiny. By training and by tradition, osteopathic
physicians practice ``hands on,'' holistic medicine and value the
highly close and interactive physician-patient relationship that is
characteristic of our profession. This philosophy has driven a unique
educational model in our medical schools. The American Association of
Colleges of Osteopathic Medicine is especially proud that the model of
osteopathic medical education is entirely consistent with the Federal
objectives of addressing physician geographic maldistribution in the
United States and increasing access to primary care services. Mr.
Chairman and Members of the Subcommittee, it is important to note that
this model has not been developed recently in response to Federal
funding requirements. Rather, it has been at the core of our
osteopathic medical education for over 100 years.
The principal vehicle for addressing the specialty and geographic
maldistribution of physicians has been through primary care education
and training. The American Association of Colleges of Osteopathic
Medicine member schools have a long history of dedication to training
primary care physicians to work in America's smaller communities, rural
areas and underserved urban areas. Osteopathic physicians represent 5.5
percent of the U.S. physician workforce, but constitute 15 percent of
the physicians practicing in communities of fewer than 2,500
population.
The mission statement of my own institution reflects this
commitment: `` Philadelphia College of Osteopathic Medicine is
dedicated to providing programs of study to educate skilled
professionals in health and science fields and competent and caring
osteopathic physicians. The programs of study are built on the
foundations of primary care, an orientation to the needs of the
community and are guided by osteopathic tradition, concept and
practice. The college is committed to the advancement of knowledge and
encouragement of intellectual growth through research and leadership
and to the advancement of the community through health promotion,
education and service.''
Mr. Chairman and Members of the Subcommittee, all of our
osteopathic medical schools share similar missions. These missions are
reflected in the profile of our medical students. Our latest data show
that over 40 percent of our entering students come from small towns and
rural areas (i.e. towns of fewer than 50,000).
The health professions assistance programs under Titles VII and
VIII of the Public Health Service Act have been valuable in our efforts
to continue to ensure this commitment. In Public Law 105-392, the
Health Professions Education Partnership Act of 1998, 44 different
Federal health professions training programs were consolidated into
seven clusters. These clusters provide support for training of
underrepresented minority and disadvantaged students; training of
primary care and dental providers; the establishment and operation of
interdisciplinary community-based training activities; health
professions workforce and analysis; public health workforce
development; nursing education; and student financial assistance. These
programs are designed to meet the health care delivery needs of the
over 2,800 Health Professions Shortage Areas in the country. Many rural
and disadvantaged populations depend on the health professionals
trained by these programs as their only source of health care. For
example, without the practicing family physicians who are currently in
place, an additional 1,332 of the United States' 3,082 urban and rural
counties would qualify for designation as primary care Health
Professions Shortage Areas.
Titles VII and VIII programs have had a significant impact in
reducing the nation's Health Professions Shortage Areas. Indeed, a
recent study estimated that if funding for Title VII programs were
doubled the effect would be to eliminate the nation's Health
Professions Shortage Areas in as little as 6 years (Politzer, RM,
Hardwick KS, Cultice JM, Bazell, C. Eliminating Primary Care Health
Professions Shortage Areas: The Impact of Title VII Generalist
Physician Education, The Journal of Rural Health, 1999: 15(1): 11-19).
A study by the Robert Graham Center showed that the receipt of
Title VII family medicine grants by medical schools produced more
family physicians and more primary care doctors serving in rural areas
and health professionals shortage areas. Over 69 percent of Title VII
funded internal medical graduates practice primary care after
graduation. This rate is nearly twice that of programs not receiving
Title VII funding.
Among the programs within these clusters that have been especially
important to enhancing osteopathic medical schools' ability to train
the highest quality physicians are: General Internal Medicine
residencies; General Pediatric Residencies; Family Medicine Training;
Preventive Medicine Residencies; Area Health Education Centers; Health
Education and Training Centers; Health Careers Opportunities Programs;
Centers of Excellence Programs; and Geriatric Training Authority.
Let me give you examples of how Title VII programs have benefited
not only the osteopathic medical schools receiving the support, but
also the citizens in the communities and states they serve.
The Philadelphia College of Osteopathic Medicine (PCOM) received a
3 year grant, now in its final year, from the Health Resources and
Services Administration to develop a predoctoral curriculum which
places significant emphasis on a comprehensive and integrative approach
to providing health care to medically underserved persons. The three
major curriculum goals are:
--To develop, implement and evaluate a teaching module which focuses
on preventive medicine for the medically underserved in a
managed care environment.
--To develop, implement and evaluate a teaching module which focuses
on understanding the roles of family and community in health
care delivery.
--To develop, implement and evaluate a teaching module which focuses
on the application of evidence-based medicine in patient care
and on becoming a self-directed learner.
This program will serve as a model for medical institutions that,
like the Philadelphia College of Osteopathic Medicine, are interested
in reaching out to medically underserved populations by training
doctors to understand the socioeconomic aspects of patients' lives in
order to provide them with the most appropriate, comprehensive, and
integrative health care.
Nova Southeastern University College of Osteopathic Medicine has a
Model Area Health Education Center (AHEC) Program Grant that serves
underserved rural and inner-city communities throughout South and
Central Florida. Nearly 500,000 people reside in the many Health
Professions Shortage Areas in this nineteen county region served by
this AHEC program. Among the many special initiatives have been an
active AHEC Rural Medicine Program, an AHEC Health Careers Camp, a
Library Without Walls Program, A Practice Opportunities Program, and
Distance Learning Teleconferences. This AHEC Program has also worked
closely with three other medical schools in Florida to develop a
Statewide Florida AHEC Network to cultivate and leverage additional
state support to maximize overall program scope and effectiveness. In
1997, this Florida AHEC Network was recognized by its peers across the
nation for its program excellence in developing an innovative and
collaborative statewide network of community/academic partnerships, and
for significantly improving the supply and distribution of primary care
health professionals in underserved communities of Florida.
The Chicago College of Osteopathic Medicine of Midwestern
University is in their third year of funding with an Establishment of
Family Medicine grant. This grant has allowed for the establishment of
a new course ``Topics in Family Medicine'' for MSII students. The
Chicago College of Osteopathic Medicine took material that was
historically taught the last eight week of the MSII year and developed
it into a full year course focusing on topics in medicine normally seen
by primary care physicians and including issues in managed care and
practice management. A simulated patient program has been incorporated
that allows students to practice dealing with difficult patient
situations such as death and dying. Community medicine sites have been
enhanced and approximately 50 new preceptors have been added. This
spring, the Chicago College of Osteopathic Medicine will sponsor a
faculty development program for all new preceptors. There have also
been great strides in the area of technology and on-line capabilities
for things such as distance learning with the students.
Title VII also authorizes student assistance programs that are
especially important to osteopathic medical students. Our students have
the highest average debt upon graduation among health professions.
Congress should be concerned with minimizing the debt load of graduates
of health professions schools, if they, in turn, can be expected to
hold down medical costs, practice in primary care, and locate in
underserved areas.
Title VII grants have been a crucial factor in the establishment
and growth of primary care departments and have enabled them to develop
innovative curricula. These grants represent the only Federal
initiative that has specifically encouraged students to consider
careers in primary care, a clearly identified national priority. With
the exception of fiscal year 2001, appropriations for Titles VII and
VIII programs have remained relatively flat for a number of years.
Thus, the ability to meet the workforce needs mentioned earlier becomes
more difficult.
Accordingly, Mr. Chairman and Members of the Subcommittee, AACOM
recommends that the fiscal year 2002 funding level for Titles VII and
VIII be $440 million. These figures do not include funding for the
children's hospitals graduate medical education program, which is an
amount separate from Titles VII and VIII funding. This funding level
would provide a much needed boost toward ensuring the training of a
workforce who will be delivering the types of services and providing
the full access to these services identified in Healthy People 2010.
Finally, Mr. Chairman and Members of the Subcommittee, the American
Association of Colleges of Osteopathic Medicine supports the Ad Hoc
Group for Medical Research Funding request of $23.7 billion for the
National Institutes of Health for fiscal year 2002. This $3.4 billion
(16.5 percent) increase represents the fourth step toward the
bipartisan goal of doubling NIH funding over the 5-year period from
fiscal year 1999 to fiscal year 2003. Although osteopathic medical
schools in the past have not engaged in research activities nearly to
the extent of our allopathic brethren, we have been steadily increasing
the research capabilities of our institutions.
Again, I appreciate the opportunity to present our views to the
Subcommittee. If I can provide you with any additional information, you
may contact either me at the Philadelphia College of Osteopathic
Medicine or Michael Dyer, Vice President for Government Relations at
AACOM (301) 968-4152.
______
Prepared Statement of the American Association of Colleges of Pharmacy
RECOMMENDATIONS FOR FISCAL YEAR 2002
[In thousands of dollars]
------------------------------------------------------------------------
Fiscal year
Public Health Service Act Title VII -----------------------------------
Programs 2002
2001 recommendation
------------------------------------------------------------------------
Health Careers Opportunity Program.. 32,800 35,000
Scholarships for Disadvantaged 44,500 48,000
Students...........................
Faculty Loan Repayment.............. 1,300 2,300
Health Professions Workforce 826 1,200
Information and Analysis...........
------------------------------------------------------------------------
Your past support of the Title VII of the Public Health Service Act
programs means improved access to care for all Americans. The health
professions students and schools supported by these programs are the
mostly likely to offer their services to underserved communities and
practice in sites like community health centers. With Title VII
programs facing substantial reductions in the President's fiscal year
2002 budget, your support for these programs is important again this
year.
The leadership and faculty of our nation's colleges and schools of
pharmacy are committed to educating professional pharmacists capable of
and comfortable with providing comprehensive pharmacy services to the
diverse populations they serve. A recent survey of the pharmacy
services provided at community health centers, conducted by the
University of Texas at Austin under a grant from the Health Resources
and Services Administration's (HRSA) Bureau of Primary Care, found that
the culturally diverse patient populations served by the CHCs benefit
from improved health promotion counseling by pharmacists with similar
cultural background.
Individuals considering pharmacy as a career choice and their
teachers (pharmaceutical education faculty, and colleges and schools)
all benefit from the Title VII programs such as:
--Health Career Opportunities Program (HCOP);
--scholarships for disadvantaged students (SLD);
--faculty loan repayment and faculty training fellowships (FLRP); and
--Centers of Excellence programs (COE).
Your support of critical Title VII programs is needed since the
diversity of the current pharmacist workforce, or any other health
professions workforce, does not mirror the diversity of our society in
general.
The fact that we need to educate more pharmacists, in general, is
supported by a congressionally mandated study that the Department of
Health and Human Services (HHS) released last December. The Pharmacist
Workforce: A Study of the Supply and Demand for Pharmacists indicates
that the demand for pharmacists will remain strong for the foreseeable
future. Improving the opportunity for students from culturally diverse
backgrounds is more important than ever. In light of the study,
targeting funds to pharmacy students and colleges and schools of
pharmacy could prove beneficial. The health workforce data HRSA
currently collects through the National Center for Health Workforce
Information and Analysis (NCHWIA) within the Bureau of Health
Professions is insufficient to assist policy makers to determine how
many active pharmacists there are. With increased appropriations NCHWIA
could establish a health professions database, including pharmacists,
that is verifiable, reliable, indicative of health professions numbers
at the state, county and local level, and not merely a repository of
statistics from professional associations and societies. This database
could also be used to improve the decision making process for placement
of National Health Service Corps personnel.
Your consideration of our recommendations is greatly appreciated.
Please do not hesitate to contact our office should you require
additional information.
______
Prepared Statement of the American Association of Pharmaceutical
Scientists
SUMMARY OF FISCAL YEAR 2002 RECOMMENDATIONS
AAPS supports the continual efforts to double the National
Institutes of Health (NIH) budget by providing a 16.5 percent increase
for fiscal year 2002, to $23.7 billion.
Basic scientific research conducted at the National Institutes of
Health or sponsored by NIH has resulted in a better understanding of
new therapies for many diseases. The American Association of
Pharmaceutical Scientists (AAPS) represents scientists in academia,
industry and government. While NIH funding does not support all of our
members, the impact of scientific discoveries derived from NIH
sponsored research has broad implications for all who are developing
new treatments. Pharmaceutical scientists trained in academic
institutions under the auspices of NIH often become noted academic,
industrial or governmental researchers. Many of these scientists create
knowledge in the pharmaceutical sciences that forms the basis for new
approaches in the treatment of the diseases that bedevil mankind. AAPS
members develop new methods of drug discovery, drug delivery and
related technologies, pharmaceutical analysis, new information
regarding drug metabolism and disposition, clinical evaluation,
pharmacoepidemiology, and pharmacoeconomics. All areas are important in
ensuring the safety, efficacy, and availability of new therapeutic
modalities.
Currently, pharmaceutical scientists advise the NIH in direct
collaborations and by participating in many study section review
boards. Many pharmaceutical scientists have been involved with ``start-
up'' biotechnology companies. A few of these entities are enormously
successful and have changed the way that some diseases are treated.
Others are involved in innovative research that may lead to the next
big breakthrough in the treatment of a number of diseases. With the
proposed reorganization of the NIH review process, this may be an
appropriate time for our 11,000 members to expand their involvement in
the evaluation of research related to the pharmaceutical sciences and
we stand ready to do so. Because of the importance of the discoveries
by NIH, AAPS urges Congressional support for funding at or above the
proposed levels. Continued NIH funding is necessary to continue the
leadership and reputation of the United States in the fields of
biomedical research and pharmaceutical sciences. There has been an
explosion of biomedical and pharmaceutical knowledge in the last few
years and it is crucial that this knowledge now be used to develop new
therapies for those in need.
______
Prepared Statement of the American College of Cardiology
INTRODUCTION
The American College of Cardiology (ACC) is a 25,000-member,
professional medical society and educational institution whose mission
is to foster optimal cardiovascular care and disease prevention through
professional education, promotion of research, and leadership in the
development of standards and guidelines and the formulation of health
policy. The ACC submits for the record this statement in support of
fiscal year 2002 funding for the National Heart, Lung, and Blood
Institute (NHLBI).
Thanks to the research support of the NHLBI, patients have
benefited from the emergence of advanced technologies, devices, and
pharmaceuticals. Medical research has played a major role in a notable
decline in the number of deaths from cardiovascular disease over the
past three decades. Yet, cardiovascular disease continues to claim more
lives each year than the next seven leading causes of death combined.
This year, it is estimated that nearly one million Americans will die
as a result of heart and blood vessel/vascular disease. More than 60
million Americans are living with one or more types of cardiovascular
disease. Fortunately, many of these individuals are living better and
more productive lives as a result of new drug and device therapies,
surgical innovations, prevention initiatives, and educational
programs--all made possible in part through NHLBI-sponsored research.
Because cardiovascular disease continues to affect the lives and
productivity of millions of Americans, and because researchers are on
the brink of many new and exciting medical discoveries, it is critical
that the subcommittee maintain its long-standing support for the NHLBI,
specifically heart-related research.
THE COST OF HEART DISEASE
In 1999, the total economic impact--direct and indirect costs--of
heart disease was $183 billion, of which $81 billion is attributed to
lost productivity--people unable to work or care for their families.
According to the National Institutes of Health (NIH), 450,000 Americans
age 65 and older require home or hospice care due to cardiovascular
disease, and congestive heart failure is the largest cause of
hospitalization for aging Americans. Investments in cardiovascular
research today will result in future savings to the health care system
and to society. According to a report issued in May 2000 by the
congressional Joint Economic Committee, it is estimated that the
average American has gained a value of $85,000 in increased longevity
from medical advances in heart disease since 1950, at a cost of $35,000
per person in research spending--a gross investment return of about 240
percent of costs.
Last year, Congress demonstrated its commitment to medical research
by providing a 15 percent increase in funding to the NIH. The ACC
recognizes this commitment and hopes Congress will continue to work
toward doubling the NIH's budget by 2003.
GROUND-BREAKING HEART RESEARCH ADVANCEMENTS
In 1991, the NIH launched the Human Genome Project. Innovative
research in human genetics holds great promise for the prevention,
diagnosis, and treatment of cardiovascular disease. Today, the NHLBI is
a leader among other NIH institutes in gene research.
In September 2000, the NHLBI launched the Programs for Genomic
Applications. This $37 million initiative is designed to advance
genomic research in the areas of heart, lung, blood, and sleep
disorders by deciphering individual genes and functions and then
applying those findings to what is already known about the mapping and
sequence of the human genome. The initiative will accelerate progress
in heart, lung, blood, and sleep research by stimulating investigator-
initiated research and by making information immediately available to
the research community, thereby allowing other scientists to develop
separate relevant studies cost effectively. Ensuring investigators have
the tools necessary to conduct genomic analysis expands the potential
for medical discovery.
NHLBI-funded researchers recently grew heart valves in laboratories
using new tissue-engineering techniques. More than 60,000 patients in
the United States receive replacement heart valves each year. Although
the valves' performance has been excellent, problems such as abnormal
clotting or poor durability limit their effectiveness. Further research
efforts are needed to improve these new tissue-engineering techniques
so that heart valves of higher durability and quality can be produced.
Scientists are hopeful that someday laboratory-grown implantable valves
will last an entire lifetime, actually growing and maturing with the
patient.
With the help of NHLBI research funding, scientists are seeking
ways for patients to grow blood vessels in the heart to replace the
ones they have lost as a result of a heart attack. During a heart
attack, blockage in coronary arteries leaves a portion of the victim's
heart tissue without oxygen. When this happens, part of the heart
tissue begins to die. Research has indicated that it is possible to
grow new blood vessels in the heart; however, this research is still in
its infancy, necessitating continued funding. This research may yield
hope that heart attack victims will someday be able to regenerate blood
vessels and keep damaged tissue alive.
SUPPORT FOR CLINICAL TRIALS
All scientific developments in biomedicine must pass through
clinical research before they can benefit patients. A critical
component of clinical research is trials that allow physicians to apply
the results of research in practice. Clinical trials can also be an
important tool in identifying early on therapeutic strategies and
pharmacological agents that have the potential to reduce health care
costs.
To alter clinical practice, large-scale randomized trials are
usually necessary to demonstrate unequivocally the effectiveness of a
new drug or device or a new application for an existing drug or device.
Some of these trials require thousands of patients to be studied over
several years. For example, funding is needed to conduct large-scale
clinical trials to study heart failure in the elderly. Large trials are
also needed to examine ways in which heart disease can be treated once
it is detected. While large-scale clinical trials require a significant
financial commitment, they hold the potential to improve patient well-
being and to reduce health care spending over time. The ACC believes
that continued funding increases are needed to significantly increase
clinical research overall, and large-scale clinical trials
specifically, while also increasing funding levels for basic research.
Funding for basic science and clinical trials must go hand-in-hand, and
there cannot be increased funding for one at the expense of decreased
funding for the other.
The ACC asks the subcommittee to ensure that increased funding be
made available for the training of clinical investigators. Clinical
investigators, or physician-scientists, are quickly becoming a ``dying
breed.'' Critical to the advancement of medical science, clinical
investigators bridge scientific discoveries and their application at
the patient bedside. Today, young physicians are being forced to choose
between performing research or practicing medicine. The demands of
managed care and other health insurance programs have further precluded
physicians from performing basic research and supervising patient care
at the same time. Incentives are needed to attract physicians to the
important field of clinical investigation. Increased resources must
also be dedicated to train a new generation of clinical investigators
who are well trained in biostatistics, research protocol designs,
bioethics, and outcomes analysis. So many of the advances in patient
care in the last 30 years have come from the research efforts of these
investigators who bridge the basic and clinical domains. They are a
vital link in our battle against premature death and disability from
heart and vascular disease, and their training must be supported.
HEART RESEARCH INITIATIVES AND OPPORTUNITIES
Congestive Heart Failure Clinical Network
It is estimated that 4.8 million Americans suffer from congestive
heart failure and that approximately 400,000 new cases are diagnosed
every year. Health care costs associated with heart failure are
estimated at $40 billion annually. More effective treatments are needed
to address this growing public health problem. The NHLBI plans to
establish a collaborative network of clinical research centers and a
data coordinating center to conduct clinical studies in heart failure.
Clinical networks have been shown to be an effective method for
translating promising basic research findings into clinical research
and practice. This initiative will allow for investigations focused on
women and minorities and on programs to train physicians in clinical
research.
Bone Formation and Calcification in Cardiovascular Disease
Evidence suggests that a relationship exists between bones and
blood vessels. Research, however, is needed to determine whether there
is a link between bone formation, repair, and breakdown (e.g.,
osteoporosis) and the development of cardiovascular disease. Scientists
already know that patients who take statin drugs to lower cholesterol
levels are at a decreased risk of bone fractures. Conversely, studies
have found that people with low bone mass may have an increased risk of
developing or dying from cardiovascular disease. Further research in
this area may lead to strategies to prevent both cardiovascular disease
and osteoporosis.
Lifestyle Intervention With Stress Management After Heart Attack
Mental stress has been shown to trigger myocardial ischemia.
Patients with coronary artery disease who experienced myocardial
ischemia following mental stress tests had higher than expected rates
of subsequent cardiac events. Results from rehabilitation and
prevention programs that included stress management interventions have
shown that behavioral interventions may improve quality of life and
reduce morbidity and mortality of patients with coronary artery
disease. However, because those trials used small sample sizes, it has
been difficult to accurately assess the effect of stress management
interventions. The NHLBI has suggested the need for a pilot study of
behavioral interventions to determine the feasibility of recruiting
patients, delivering interventions, ascertaining the effects on
adherence, and assessing the progression of coronary artery disease and
other clinical outcomes.
Public Access to Defibrillation
About one fourth of the 300,000 annual deaths from sudden cardiac
arrest occur outside the home--in public areas. In August 2000, the
NHLBI launched a nationwide pilot program to test public access to
automated external defibrillators (AEDs). AEDs are devices that
automatically analyze heart rhythms and deliver an electric current to
the heart of a cardiac arrest victim. Survival rates after cardiac
arrest are low, averaging 4 percent. However, survival rates can be
increased by shortening the time to defibrillation. The study will
place AEDs in 24 communities across the Unites States and Canada.
Researchers already know that AEDs save lives. The purpose of this
study is to look at the life-saving potential and cost effectiveness of
AEDs when used by trained lay-individuals. When the study, which will
be conducted over 30 months, is complete, 1,000 sites will be equipped
with AEDs. As of March, 850 of those sites had been approved for the
placement of AEDs.
Recognizing the critical importance of early defibrillation, the
ACC asks the subcommittee to support $12.5 million in funding for
implementation of the Rural Access to Emergency Devices Act, Public Law
106-505, the Public Health Improvement Act. The funding will be used to
help rural communities buy AEDs and to train rural emergency responders
in the use of AEDs.
PREVENTION, EDUCATION, AND PRACTICE
Efforts must be strengthened to prevent the incidence of heart
attacks, coronary heart disease, heart failure, and high blood pressure
through increased patient and physician education if we are to win the
war against heart disease. We know that heart disease is linked
definitively to hypertension, high cholesterol, obesity, diabetes,
smoking, and physical inactivity. The NHLBI's public education
programs--the National High Blood Pressure Education Program, the
National Cholesterol Education Program, the Obesity Education
Initiative, and the National Heart Attack Alert Program--make
information readily available to patients, families, and health
professionals.
The earlier that heart disease is detected, the better it can be
treated to prevent its development. In September 2000, the NHLBI
launched a 10-year, multi-center study to find new ways of detecting
heart disease early, before it produces symptoms. The $68 million
Multi-Ethnic Study of Atherosclerosis involves six centers, which will
recruit 6,500 participants. The hope is that the study will yield more
specific predictors of heart disease and will determine which factors
best predict heart disease in men and woman and in different ethnic
groups.
One of the fastest growing public health problems in this country
is adult and childhood obesity. People who are overweight or obese are
at greater risk for several major diseases, including heart disease and
stroke. More than 108 million adults in the United States are
overweight or obese. Even more startling, an estimated 5 million
children in this country between age six and 17 are considered
overweight.
Just recently, the NHLBI unveiled a new tool for health care
providers and the public to combat obesity. A ``practical guide'' is
now available to physicians and other health care professionals. The
guide includes a 10-step plan and a quick reference tool to help
physicians assess, classify, and treat patients who are overweight and
obese. The guide also includes information for patients on diet,
physical activity, and tools for behavioral change.
The NHLBI has also funded research targeted at the prevention and
treatment of obesity. NHLBI-funded researchers have found that in
overweight individuals, high dietary sodium intake is strongly
associated with an increased death rate, particularly from
cardiovascular disease. The average adult in the United States consumes
well above the recommended daily sodium level of 2,400 milligrams.
Knowing this, physicians and other health care providers can suggest
reducing sodium intake as a low-cost intervention for those who have
difficulty losing weight as a way to help lower their risk of death
from cardiovascular disease.
Another NHLBI study has shed new light on genetic predisposition to
obesity. Additional research is needed to gain a better understanding
of the leptin receptor gene, the gene linked to fat accumulation.
Researchers have found that a variation in the leptin receptor gene is
associated with higher fat levels in middle-age white males, but not in
black males or in women of either race. This suggests that leptin
therapy may be effective only in middle-age white males, and that other
genetic factors influence excess fat accumulation in women and blacks.
Understanding the leptin receptor gene will be an important step in
developing effective preventive and therapeutic strategies to fight
obesity.
There is much to be done to ensure that preventive and therapeutic
measures proven effective in the fight against cardiovascular disease
are adopted by physicians. Cardiovascular drugs, such as anti-
hypertensives and beta-blockers, have played a key role in the decline
of heart disease-related deaths. Beta-blockers, drugs that are used to
slow the rate and force of the heart's contractions and to stabilize
the heart's rhythm, are still underused in treating heart attack
patients in the emergency room. Funding is needed to gather evidence-
based information that can be used to improve health care practices by
physicians and other health care providers. The ACC supports increased
funding to the Agency for Healthcare Research and Quality for the
purposes of improving health care quality.
CONCLUSION
Beyond better public awareness and the incorporation of research
advances into practice, reducing the number of cardiovascular-related
deaths is greatly dependent upon research sponsored by the NHLBI. We
must intensify our cardiovascular disease research efforts now in an
effort to prevent an increase in the prevalence of cardiovascular
disease that will otherwise accompany the aging of the so-called
``baby-boomer'' generation. The ACC hopes the subcommittee shares its
optimism about the unique opportunities scientists and clinical
investigators now have to achieve their long-standing goal of
conquering this nation's number-one killer. In summary, the ACC
encourages the subcommittee to provide a funding level of at least
$2.679 billion for the NHLBI in fiscal year 2002. Furthermore, the ACC
asks that at least $1.650 billion of that amount be devoted to heart-
and stroke-related research.
The ACC hopes the subcommittee will consider this request. It is a
wise investment in the future health of our nation.
______
Prepared Statement of the American Dental Hygienists' Association
On behalf of the American Dental Hygienists' Association (ADHA),
thank you for the opportunity to present testimony regarding fiscal
year 2002 appropriations for the Department of Health and Human
Services. I am Stan Peck, ADHA's Executive Director.
ADHA is the largest national organization representing the more
than 100,000 dental hygienists across the country. Dental hygienists
are preventive oral health professionals who are licensed in each of
the fifty States. As prevention specialists, dental hygienists
understand that recognizing the connection between oral health and
total health can prevent disease, treat problems while they are still
manageable, and conserve critical health care dollars. Dental
hygienists are committed to improving the nation's oral health, a
fundamental part of total health. Please visit the ADHA web site at
<>.
U.S. SURGEON GENERAL'S MAY 2000 REPORT ON ORAL HEALTH IN AMERICA
Last May, U.S. Surgeon General David Satcher issued ``Oral Health
in America: A Report of the Surgeon General.'' This landmark report
confirms what dental hygienists have long known: that oral health is an
integral part of total health and that good oral health can be
achieved. Key findings enumerated in the Report include:
--Oral diseases and disorders in and of themselves affect health and
well-being throughout life.
--Safe and effective measures exist to prevent the most common dental
diseases--dental caries (tooth decay) and periodontal diseases.
--Lifestyle behaviors that affect general health such as tobacco use,
excessive alcohol use, and poor dietary choices affect oral and
craniofacial health as well.
--There are profound and consequential oral health disparities within
the U.S. population.
--More information is needed to improve America's oral health and
eliminate health disparities.
--The mouth reflects general health and well-being.
--Oral diseases and conditions are associated with other health
problems.
--Scientific research is key to further reduction in the burden of
diseases and disorders that affect the face, mouth and teeth.
The Surgeon General's Report on Oral Health challenges all of us--
in both the public and private sectors--to address the compelling
evidence that not all Americans have achieved the same level of oral
health and well-being. The Report describes a ``silent epidemic'' of
oral diseases, which affect our most vulnerable citizens--poor
children, the elderly and many members of racial and ethnic minority
groups. The Surgeon General insists that additional steps be taken to
address these disparities in oral health status.
ADHA suggests that one such step is to improve access to the
preventive oral health care services provided by dental hygienists.
This is important because unlike most medical conditions, the three
most common oral diseases--dental caries (tooth decay), gingivitis (gum
disease) and periodontitis (advanced gum and bone disease)--are proven
to be preventable with the provision of regular oral health care.
Despite this prevention capability, tooth decay--which is an infectious
transmissible disease--still affects more than half of all children by
second grade. Clearly, more must be done to increase children's access
to oral health care services.
While the profession of dental hygiene was founded in 1923 as a
school-based profession, today the provision of dental hygiene services
is largely tied to the private dental office. Increased utilization of
dental hygienists in schools, nursing homes, and other sites--with
appropriate referral mechanisms in place to dentists--will improve
access to needed preventive oral health services. This increased access
to preventive oral health services will likely result in decreased oral
health care costs per capita and, more importantly, improvements in
oral and total health.
ADHA is committed to working with the Congress to improve access to
oral health care services, particularly for children eligible for
Medicaid and the State Children's Health Insurance Program (SCHIP).
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
As the Surgeon General's Report on Oral Health so clearly
demonstrates, the nation's oral health can and must be further
improved. The National Institute of Dental and Craniofacial Research
(NIDCR) is the nation's focal point for oral health research and
NIDCR's work has yielded significant advancements in oral health.
Moreover, NIDCR's work in dental research has not only resulted in
better oral health for the nation, it has also helped curb increases in
oral health care costs. Americans save nearly $4 billion annually in
dental bills because of advances in dental research and an increased
emphasis on preventive oral health care. To enable NIDCR to continue
and to build upon its important research mission, ADHA joins with other
groups in the oral health community to recommend $370 million for
NIDCR.
ORAL HEALTH INITIATIVE
ADHA is pleased to see the increasing recognition among federal
Policymakers of the importance of oral health to overall health and
well-being. A primary illustration of this appreciation for the link
between oral health and general health is the Oral Health Initiative at
the Health Resources and Services Administration (HRSA). The goals of
HRSA's Oral Health Initiative are to work toward the elimination of
disparities in oral health status and to improve access to oral health
services. Regretfully, much work needs to be done in both of these
areas to help assure that children enrolled in Medicaid and the State
Children's Health Insurance Program (SCHIP) are provided access to
necessary oral health services.
As the General Accounting Office (GAO) confirmed last year in two
separate reports to Congress, ``dental disease is a chronic problem
among many low-income and vulnerable populations'' and ``poor children
have five times more untreated dental caries (cavities) than children
in higher-income families.'' The GAO further found that the major
factor contributing to the low use of dental services among low-income
persons who have coverage for dental services is ``finding dentists to
treat them.'' ADHA pledges to work with HRSA to achieve the goals of
the Oral Health Initiative. Increased utilization of dental hygiene
services--appropriately linked to the services of dentists--is critical
to addressing the nation's crisis in access to oral health care for
vulnerable populations.
Because access to preventive oral health services is vital to
children's health and wellbeing, ADHA urges a minimum of $20 million
for HRSA's Oral Health Initiative so that access to oral health
services for Medicaid and SCHIP children will improve and disparities
in oral health status will be lessened. A portion of these monies would
be used to fund important children's health projects authorized in the
``Children's Health Act of 2000.''
ADHA further urges that the Oral Health Initiative receive a
separate line item in the budget. This consolidation into a line item
will vastly improve coordination of HRSA's various oral health
activities.
CENTERS FOR DISEASE-CONTROL DIVISION OF ORAL HEALTH
ADHA would also like to lend its support to the Division of Oral
Health within the Centers for Disease Control (CDC). Specifically, ADHA
joins with other dental groups in urging a budget of $17 million for
the Division of Oral Health at CDC. This funding level will enable the
Division of Oral Health to continue its vital work to control and
prevent oral disease, including its important work in the area of
community water fluoridation and school-based dental sealant programs
as authorized in the ``Children's Health Act of 2000.''
RYAN WHITE HIVAIDS DENTAL REIMBURSEMENT PROGRAM
Included in the Ryan White CARE Act is a dental reimbursement
program that assists in meeting the oral health needs of people living
with HIV/AIDS, most of whose care is not covered under existing federal
and state assistance programs. The dental reimbursement program
provides participating institutions with partial reimbursement for the
cost of providing oral health care services to low income people living
with HIV and AIDS. In 1999, oral health care was provided to more than
65,000 patients under the program.
The ``Ryan White CARE Act Amendments of 2000'' would--for the first
time--render dental hygiene programs eligible for the dental
reimbursement program. There are presently 255 accredited dental
hygiene education programs in the United States. In fact, all States,
with the exception of Montana, have at least one dental hygiene
education program. Currently, there are 55 dental schools.
Federal support for the provision of oral health services through
dental hygiene programs to HIV positive individuals will not only
provide greatly needed oral health services, but will also afford
dental hygiene students important education opportunities. ADHA joins
with the American Dental Education Association in recommending $15
million for this important program.
CHIEF DENTAL OFFICER
ADHA further urges that the position of Chief Dental Officer at the
Health Care Financing Administration (HCFA) be made permanent. While
this vital position has historically received funding, it is not now
permanent. Given the increasing recognition of the importance of oral
health and the key role of HCFA's Chief Dental Officer, it is
imperative that this position be institutionalized.
ALLIED HEALTH
ADHA joins the Allied Health Roundtable in supporting the important
work of Title VII of the Public Health Service Act and recommends 521
million for Allied Health Project Grants. Allied health disciplines
constitute fully 60 percent of the health care work force. With the
acknowledged need for cost-effective health care providers, it is time
to augment funding for and recognition of these important allied health
programs. ADHA further encourages funding for federal programs in
HRSA's Minority and Disadvantaged Health Professionals Training
Cluster. These important programs recruit and retain minority and
disadvantaged students.
MATERNAL AND CHILD HEALTH PROGRAM
Title V Maternal and Child Health (MCH)/Children with Special
Health Care Needs programs have had a history of supporting the public
oral health infrastructure, for providing the population-based
prevention programs, such as water fluoridation or dental screenings,
and for providing direct and enabling oral health services when
necessary. Despite this important work, the Maternal and Child Health
program has not enjoyed the level of spending growth over the last ten
years that many other public health programs have realized. ADHA
strongly supports the MCH programs and urges $850 million for fiscal
year 2002, which is full funding at the level authorized last year.
CLOSE
In closing, the American Dental Hygienists' Association appreciates
the important contributions this Subcommittee has made in improving the
quality and availability of oral health services throughout the
country. ADHA is committed to working with this Subcommittee--and all
Members of Congress--to improve the nation's oral health which, as Oral
Health in America: A Report of the Surgeon General so rightly
recognizes, is a vital part of overall health and well-being.
Thank you for this opportunity to submit the views of the American
Dental Hygienists' Association.
______
Prepared Statement of the American Lung Association (ALA) and the
American Thoracic Society (ATS)
The American Lung Association (ALA) and the American Thoracic
Society (ATS) are very pleased that President Bush has committed his
Administration to doubling the NIH budget by fiscal year 2002. To keep
the NIH budget on course towards doubling the budget in 2003 will
require a 16.5 percent increase in fiscal year 2002. We look forward to
working with this committee to bring the campaign pledges of President
Bush to fruition. Mr. Chairman, while our comments today will focus on
selected parts of the Public Health Service, the American Lung
Association and the American Thoracic Society are firmly committed to
appropriate funding for all parts of our nation's public health
infrastructure.
There are 3 specific issues that ALA/ATS would like to bring to
your attention.
SHORTAGE OF PHYSICIAN-INVESTIGATORS
Mr. Chairman while investments in biomedical research at NIH will
make tremendous strides in the health of our nation, the ALA/ATS feel
there is a fundamental flaw in the research enterprise. That flaw is
the shortage of physician-investigators. Physician-investigators are
MDs or MD/PhDs who devote a significant share of their time to
conducting research.
Physician-investigators are essential to the research enterprise
because they link the worlds of patient care and bench research.
Physician-investigators are best equipped to translate the needs of the
patients they serve into research questions. The active presence of
physician-investigators is essential to keep biomedical research
focused on the needs of the patient.
In recent years, the number of new physician-investigators applying
for NIH grants has diminished. NIH must take action to ensure new
physician-investigators are entering the field of research.
Last year, Congress enacted the Clinical Research Enhancement Act.
This legislation will take a number of steps to address the shortage of
physician-investigators involved in clinical research. While the
legislation is an excellent first step, we feel the shortage of
physician-investigators is not limited to just clinical research but
extends to shortages of physician-investigators in all disciplines of
biomedical research.
The ALA/ATS recommends Congress continue to support activities
called for in the Clinical Research Enhancement Act, but consider
extending the support mechanisms to all physician-investigators. We
also recommend NIH raise the low training stipends paid to students.
The $35,000 paid to fifth year post-doctoral students is extremely low
considering the $95,000 average debt physicians have after medical
school.
National Heart, Lung, and Blood Institute AIDS Budget
Last year, the Administration's budget proposed to flat fund the
AIDS Budget at the National Heart, Lung, and Blood Institute. Mr.
Chairman, as you may know, opportunistic pulmonary illnesses (like
tuberculosis, pneumonia and influenza) are the leading cause of death
for people with AIDS. Adequate funding is needed for the NHLBI to
continue to study the interaction of these illnesses in the lungs of
people with HIV. We are pleased to report that, with the good help of
this subcommittee, the National Heart Lung and Blood Institute has
increased its investment in investigating the interactions between
tuberculosis and HIV.
The ALA/ATS want to thank the committee for its help in bringing
attention to the valuable work done at NHLBI on tuberculosis and AIDS.
We hope we can count on the Subcommittee to continue that interest in
this small, but important program.
Fogarty International Center TB Training Programs
The Fogarty International Center at NIH provides training grants to
U.S. universities to teach international physicians and researchers
AIDS treatment and research techniques. The goal of the program is to
develop a cadre of health professionals in the developing world to
begin to control the global AIDS epidemic.
Because of the linkage between AIDS and TB infection, FIC has
created supplemental TB training grants for these institutions to train
international health care professionals in the area TB treatment and
research. This supplemental program has been highly successful in
beginning to create the human infrastructure to treat the nearly 2
billion people who have TB worldwide.
However, we believe TB training grants should not be offered
exclusively to institutions that have received AIDS training grants.
The TB grants program should be expanded and open to competition from
all institutions. The ALA/ATS recommend Congress provide an additional
$3 million for FIC to expand the TB training grant program from a
supplemental grant to an open competition grant.
MAGNITUDE OF LUNG DISEASE
This year over 350,000 Americans will die of lung disease. Lung
disease is third leading cause of death in the U.S., responsible for
one in every seven deaths. More than 25 million Americans suffer from a
chronic lung disease. Lung diseases cost the U.S. economy an estimated
$89.1 billion annually.
Lung diseases represent a spectrum of chronic and acute conditions
that interfere with the lung's ability to extract oxygen from the
atmosphere, protect against environmental or biological challenges and
regulate a number of metabolic processes. Lung diseases include:
chronic obstructive pulmonary disease, lung cancers, tuberculosis,
pneumonia, influenza, sleep disordered breathing, pediatric lung
disorders, occupational lung disease, sarcoidosis, and asthma. While
lung disease encompasses many illnesses, these comments will focus on
two illness, asthma and tuberculosis.
ASTHMA
Asthma is a chronic lung disease in which the bronchial tubes of
the lungs become swollen and constrict, preventing air from getting
into or out of the lung. These obstructive spasms of the bronchi are
caused by a broad range of environmental triggers that vary from one
asthma-sufferer to another.
Asthma is on the rise. A 1998 survey found that an estimated 26
million Americans (8.6 million children under the age of 18) have been
told by their doctor they have asthma. Rates are increasing for all
ethnic groups and especially for African American and Hispanic
children. While some children appear to out grow their asthma when they
reach adulthood, 75 percent will require life-long treatment and
monitoring of their condition.
Asthma is expensive. The growth in the prevalence of asthma will
have significant impact on our nation's health expenditures, especially
Medicaid. Currently, asthma costs the United States over $8.1 billion
in direct medical expenditures. Hospital inpatient visits account for
$3.2 billion in asthma expenses. Asthma attacks bring 1.9 million
people to the emergency room each year.
Asthma kills. In 1998, 5,438 people in the U.S. died as a result of
an asthma attack. That is a 209 percent increase from 1979. A
disproportionate share of these deaths occurred in African American
families.
Federal Response to Asthma
The federal response to asthma has three components; research,
programs and planning. We are pleased to report that, with support from
the Subcommittee, we are making progress on all three fronts.
FEDERAL RESPONSE TO ASTHMA--RESEARCH
As the prevalence of asthma has grown, so has asthma research.
Researchers are developing better ways to treat and manage chronic
asthma. Research supported by National Heart, Lung and Blood Institute
(NHLBI) has shown that using corticosteroids to treat children with
mild to moderate asthma is safe and effective. For several years there
had been concern that corticosteriods would stunt the growth of
children who used them. The five-year study showed that children had a
one-year small reduction in their growth rate. But they had normal
growth rates compared with children who did not use corticosteriods for
the following 4 years. Children who used corticosteroids did suffer
fewer asthma attacks and fewer trips to the emergency room.
Genetic research is also providing insights into asthma. Physicians
have noticed that while most people respond well to inhaled beta-
agonists--a commonly prescribed drug to treat asthma--some patients do
not response or have worse asthma using inhaled beta-agonists.
Researchers in the NHLBI supported Asthma Clinical Research Network
have discovered that a genetic variation in the beta-adrenegric
receptor determines how well asthma patients will respond to inhaled
beta-agonists. This discovery will enable physicians to better target
the drugs they proscribe to treat asthma.
Basic research is also learning more about asthma. Researchers
supported by NHLBI have developed better animal models to allow
expression of selected asthmatic genetic traits. This will allow
researchers to develop a greater understanding of how genes and
environmental triggers influence asthma's onset, severity and long-term
consequences.
FEDERAL RESPONSE TO ASTHMA--PROGRAMS
Last year, Congress provided approximately $27 million for CDC to
conduct asthma program and tracking activities. CDC will use these
funds to conduct asthma outreach, education and tracking activities. In
Ohio, Case Western University and Rainbow Babies and Children's
Hospital have been awarded funds to conduct an asthma intervention
program. However, at the current level of funding, less than half the
states have funds to respond to asthma. The ALA/ATS recommend that CDC
be provided $50 million to expand its asthma programs.
FEDERAL RESPONSE TO ASTHMA--PLANNING
Last year, Congress enacted legislation that directs the National
Asthma Education and Prevention Program (NAEPP) at NHBLI to develop a
plan for the federal government to respond to the growing asthma
epidemic in the U.S. The plan will include recommendations on research,
public health, tracking, education and treatment activities. The ALA/
ATS supports this planning process and looks forward sharing the
recommendations of the NAEPP Federal Asthma Plan with this Subcommittee
in the near future.
IOM Report: Ending Neglect--the Elimination of Tuberculosis in the
United States
Mr. Chairman, tuberculosis has been with us since the dawn of time.
Tuberculosis is an airborne infection caused by a bacterium,
Mycobacterium tuberculosis (TB). TB primarily affects the lungs but can
also affect other parts of the body, such as the brain, kidneys or
spine.
TB is spread through coughs, sneezes, speech and close proximity to
someone with active tuberculosis. People with active tuberculosis are
most likely to spread TB to others they spend a lot of time with, such
as family members or coworkers. It cannot be spread by touch or sharing
utensils used by an infected person.
There are an estimated 10 to 15 million Americans infected with
latent TB, with the potential to develop active TB in the future. About
10 percent of these individuals will develop active TB disease at some
point in their lives. In 1998, over 18,000 cases of active TB were
reported in the United States.
The Institute of Medicine (IOM) recently published a report on how
the United States has responded to tuberculosis. The IOM report
documents the cycles of attention and progress toward TB elimination,
the periods of insufficient funding and the re-emergence of TB. The
ALA/ATS is pleased to report that, at the moment, TB rates in the U.S.
are on the decline. From a high in 1992 of 26,673 new cases, we have
seen 7 straight years of decline in TB rates.
While declining TB rates is good news, the emergence and spread of
multi-drug resistant TB poses a significant threat to the public health
of our nation. Continued support is need if the U.S. is going to
continue progress toward the elimination of TB.
The IOM report provides the United States with a road map of
recommendations on how to eliminate TB in the United States. The IOM
report identifies needed detection, treatment, prevention and research
activities. The American Lung Association and the American Thoracic
Society endorse the IOM report and its recommendations. We estimate it
will cost $528 million for the CDC Tuberculosis Elimination Program to
implement the IOM report recommendations.
The National Institutes of Health also has a prominent role to play
in the elimination of TB. Currently there is no highly effective
vaccine to prevent TB transmission. However, the recent sequencing of
the TB genome and other research advances have put the goal of an
effective TB vaccine within reach. The National Institutes of Allergy
and Infectious Disease have developed a Blueprint for Tuberculosis
Vaccine Development. ALA/ATS encourage the Subcommittee to fully fund
the TB vaccine effort.
NIOSH--Researching and Preventing Occupational Lung Disease
In 1998, approximately 66,000 Americans died from work-related
injuries or illnesses; 392,000 newly diagnosed cases of occupational
illnesses and 5.5 million non-fatal work injuries were reported.
Workplace illness and injury will cost the U.S. economy $171 billion
this year.
To protect the health of our nation's workforce will require
research, training, tracking and new technologies. The ALA/ATS
recommend that the Subcommittee provide a $50 million increase for the
NIOSH budget including $25 million for the NIOSH National Occupational
Research Agenda (NORA). NORA represents a partnership research plan for
occupational disease. The NORA agenda was developed with input from
labor, business and the health community.
A recent IOM Report--``Safe Work in the 21st Century: Education and
Training Needs for the Next Decades Occupational Safety and Health
Personnel,'' identified a growing shortage of trained occupational
health professionals in the United States. Unlike the majority of
medical subspecialties, occupational health professionals do not
receive Medicare training support. We recommend $10 million to increase
training opportunities for occupational health professionals. The ALA/
ATS believe more funds are needed to track the incidence of serious
work-related illnesses and injury. We recommend $10 million for
surveillance data on workplace safety.
LUNG-DISEASE OPPORTUNITIES AND ADVANCES
Previously, the ALA/ATS reported that NHLBI-supported researchers
found that retinoic acid can reverse the effects of emphysema in
laboratory rats. The ALA/ATS is pleased to report that studies have
gone from rats to non-human primates and that results continue to be
encouraging. NHLBI is taking steps to test retinoic acid treatment in
people. We appear to be one step closer to finding a way to reverse the
effects of emphysema--what was once considered an irreversible,
debilitating disease.
NHLBI and Medicare are continuing to investigate the efficacy of
the Lung Volume Reduction surgery in the National Emphysema Trial
(NET). This clinical trial will help evaluate the best combination of
surgical and rehabilitation therapy for people with emphysema.
NHLBI is continuing its support for sleep-related research. It has
been observed that people who suffer from inadequate sleep appear to
recover more slowly from infections. NHLBI is supporting research to
better understand the genetic basis of sleep-immune interactions.
NHLBI-supported researchers have made strides in understanding the
health effects sleep apnea and have identified genes in dogs that cause
narcolepsy. The discovery of the narcolepsy gene in dogs will help
guide further research in humans.
Researchers have discovered a genetic defect that may cause
familial primary pulmonary hypertension (PPH) in humans. PPH is a rare
but serious disease in which blood pressure in the pulmonary artery
becomes extremely high. Discovering the gene for familial PPH will help
researchers discover the cause of this rare and fatal disease and
should lead to improved treatments for PPH.
In conclusion, Mr. Chairman, lung disease is a growing problem in
the United States. It is America's number three killer, responsible for
one in seven deaths. The lung disease death rate continues to climb.
Overall, lung disease and breathing problems constitute the number one
killer of babies under the age of one year. Worldwide, TB kills 3
million people each year, more people than any other single infectious
agent. Mr. Chairman, the level of support this committee approves for
lung disease programs should reflect the urgency illustrated by these
numbers.
______
Prepared Statement of the American Gastrotenterological Association
SUMMARY OF RECOMMENDATIONS
The American Gastroenterological Association (``AGA'') urges
Congress to increase funding for medical research on digestive diseases
and disorders through budgetary increases to the National Institutes of
Health (``NIH''), the Centers for Disease Control and Prevention
(``CDC''), and the Agency for Healthcare Research and Quality
(``AHRQ'').
Specifically, AGA encourages Congress to provide at least a 16.5
percent increase over fiscal year 2001 for NIH, raising the funding
levels from $20.3 billion to $23.7 billion, as recommended by the Ad
Hoc Group for Medical Research Funding. Within NIH, AGA recommends at
least a commensurate 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''), each of which support a considerable
portfolio of gastrointestinal research. These increases would allow for
further research on the diagnosis, treatment and cure for debilitating
and devastating digestive diseases.
AGA also urges Congress to increase funding over fiscal year 2001
by 29 percent to $5.0 billion for the CDC as recommended by the CDC
Coalition, and by 40 percent to $400 million for AHRQ as recommended by
the Friends of AHRQ.
MEDICAL RESEARCH RECOMMENDATIONS
AGA is the nation's oldest, not-for-profit specialty medical
society, consisting of over 11,000 gastroenterologic physicians and
scientists who are involved in research, clinical practice, and
education on disorders of the digestive system. As the nation's leading
voice on gastrointestinal research, 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 are obesity,
gastrointestinal cancers, inflammatory bowel disease, motility
disorders and foodborne illness. This testimony focuses on these
serious health problems and makes recommendations on how Congress
should allocate this country's precious medical research dollars to
combat digestive diseases.
Nutrition and Obesity
110 million adults in this country are either overweight (61
million) or obese (49 million); 31.3 percent of men and 34.7 percent of
women are considered to be clinically obese; one in five children are
clinically obese. The number of obese adults in the United States has
doubled in the last 25 years.
The costs to society are both direct and indirect, and include
increased medical expenses, loss of productivity in the workplace,
disability claims and job discrimination. Approximately 300,000 adult
deaths in the United States each year are attributable to obesity.
Obesity is a major health problem in the United States because of
its marked prevalence, causal relationship with serious medical
diseases and considerable economic impact. Obesity is a major cause of
gastrointestinal diseases such as gall bladder disease, liver disease
(including cirrhosis of the liver), and colorectal cancer. Treatment of
obesity and diseases directly related to it accounts for 5 percent to 7
percent of total health care costs annually.
Despite the fact that obesity is gaining more recent attention, a
significant amount of ground must be covered before medical research
catches up with the need to address the problem in a comprehensive
manner. There are a growing, but inadequate, number of grants being
funded to examine this disease.
AGA recommends that Congress urge NIDDK, the National Institute of
Child Health and Human Development, the Office of Research on Women's
Health and the Center for Research on Minority Health to increase RO1
funding for obesity research by 15 percent for fiscal year 2002 and to
encourage the institutes to consider RFA's on the effects of obesity on
gene expression, particularly as it relates to GI cancers, including
colon cancer. Additionally, research into the effect of diet and
nutrient intake on mucosal function, metabolism and gene function will
provide insight into how nutrients affect gut function. Furthermore,
the institutes should increase advanced research training at the basic
level (KO8) and clinical level (K23) by 25 percent in fiscal year 2002.
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.--70 percent to 80 percent of colorectal cancer cases
involve average-risk individuals. If diagnosed early, this
cancer is highly curable. As such, research and early detection
through screening remains the key to preventing, treating, and
curing this disease. We encourage Congress to require coverage
for screening for all Americans. Further, we urge Congress to
support additional research on colorectal cancer.
--Pancreatic cancer will be diagnosed in 28,300 Americans in 2001
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.
--Of increased concern to AGA are esophageal and stomach cancers.
These are the second most common gastrointestinal cancers.--It
is projected that nearly 34,000 Americans will be diagnosed and
more than 25,100 will die in 2001 from these cancers. 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'').
AGA applauds the NCI for its commitment to improving the
understanding of, and seeking cures to, these and other
gastrointestinal cancers. However, more research is needed. Congress
should encourage the NCI to likewise establish a Progress Review Group
on espohgeal and stomach cancers. Congress also should urge the NIDDK
to augment its efforts in these areas, and to particularly focus
resources on the genetic aspects of these cancers, diagnostic tests for
genetic abnormalities and prevention of these cancers, the modulation
and understanding of epithelial injury and repair the environmental
factors relating to the development of these diseases, and the
development and treatment of Barrett's Syndrome in patients with GERD.
Most cases of these cancers are detected too late to be effectively
treated. However, CDC's National Colorectal Cancer Screening Awareness
program is helping to inform the public that early detection through
regular screening is important. Congress should support CDC's
Colorectal Cancer Screening Awareness program with $15 million in
fiscal year 2002, an increase of $6 million over fiscal year 2001.
Inflammatory Bowel Disease
It is estimated that 1 million Americans have inflammatory bowel
disease (``IBD''). 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. People with IBD experience
abdominal pain, fever, bowel sores, intestinal bleeding, anorexia,
weight loss, fullness, diarrhea, constipation, and vomiting. In severe
cases, the patient can hemorrhage or contract sepsis/toxemia resulting
in death.
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 30 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.
Further research is needed in this area both due to the high
prevalence of this disease as well as the lack of knowledge on how to
identify, diagnose, and cure the disease. AGA urges Congress to direct
the NIDDK to focus additional resources on IBS. 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). Additionally, AGA urges Congress to also 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.
Foodborne Illness
Foodborne illnesses are estimated to cost annually $5 to $6 billion
in direct medical costs and productivity losses. Due to poor reporting
of foodborne incidents, experts vary on the number of Americans
affected annually from a conservative 6 million to over 80 million.
AGA recommends that Congress encourage the NIH, including NIDDK and
NIAID, and others conducting foodborne illness research like the United
States Department of Agriculture (``USDA'') and the CDC to concentrate
more intensively on research into treatments for foodborne illness. AGA
thus 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 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.
MEDICAL RESEARCH INFRASTRUCTURE
Digestive Disease Research Centers
Digestive Diseases Research Core Centers are key to establishing
strong research networks and advancing medical knowledge. Currently,
fourteen fully funded centers exist which conduct basic and clinical
research on a variety of digestive disorders. They have been highly
successful in expanding medical knowledge on a variety of GI diseases
and disorders. AGA urges Congress to instruct NIDDK to expand the
number of centers by adding one new 5-year center in each of the next 2
years such that sixteen centers are fully supported. These new centers
should focus on genomic and proteomic approaches to gastrointestinal
research. Moreover, NIDDK should maintain full funding for those
centers already in existence.
Small Equipment Grants
As technology continues to evolve, laboratory research equipment is
becoming more expensive to purchase and maintain. NIH's current Shared
Instrumentation Grant Program offers equipment grants for which
researchers can apply for equipment with a minimum cost of $100,000;
appropriate for use in replacing pieces of large equipment. However, a
similar grant program does not exist to assist researchers in replacing
less expensive ($50,000-$100,000), often highly utilized, pieces of
equipment. Researchers' small equipment needs are just as critical as
larger pieces of equipment and the cost of replacing such
instrumentation can be prohibitively expensive to support on a single
grant application. Therefore, AGA urges Congress to suggest that NIH
study the need for a small equipment grant program comparable to the
existing Shared Instrumentation Grant Program.
Training of Physician-Scientists
While research has expanded our medical knowledge and enabled
physicians and other 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).
AGA views this problem as an immediate and serious threat to the
future of biomedical research generally, and gastrointestinal research
in particular. To alleviate this growing problem, AGA urges Congress to
increase funding for the continued expansion of clinical research and
clinical research training opportunities. To achieve this Congress
should take the following steps: career support for established
clinical investigators, especially to enable them to mentor new
investigators; and appropriate funding to NIH for the implementation of
the loan repayment provisions of the Clinical Research Enhancement Act.
NIH Budget Doubling Initiative
Medical research endeavors and America's patients have benefited
tremendously from the 5-year effort to double the NIH budget. However,
researchers recognize that there may be ramifications once the NIH
budget has been doubled, and annual funding increases return to pre-
initiative levels. It is imperative that Congress not permit NIH
funding to stagnate upon achieving the goal doubling the NIH budget.
Therefore, in order to prevent a funding crisis that results in a
retreat from the significant progress that has been made, AGA
recommends that Congress plan for the post-doubling period accordingly.
Additionally, Congress should applaud NIH for working to develop a
funding strategy for post-fiscal year 2003, encourage further budget
modeling exercises at NIH, and afford NIH the maximum amount of
flexibility to address post-budget doubling funding levels.
CONCLUSION
The diseases described above continue to take a huge toll on
America's health and economy. Congress must keep up the momentum it has
started, and in some cases, devote even more resources. AGA appreciates
the opportunity to present its views on the fiscal year 2002
appropriations. Please call Michael Roberts, Vice President of Public
and Government Relations at AGA, at (301) 941-2618 if you have further
questions.
______
Prepared Statement of the American Heart Association
It is highly likely that heart attack or stroke will cause your
death or disability or that of a loved one. Heart attack, stroke and
other cardiovascular diseases remain America's leading cause of death
and a major cause of disability. Cardiovascular diseases account for
nearly 1 of every 3 deaths in the United States.
The American Heart Association works to reduce death and disability
from heart attack, stroke and other cardiovascular diseases. We commend
this Committee for making fiscal year 2001 funding for the National
Institutes of Health and for the Centers for Disease Control and
Prevention a priority. But, we are concerned that our government is
still not devoting sufficient resources for research and prevention to
America's No. 1 killer--heart disease--and to our country's No. 3
killer and a leading disabler--stroke.
STILL NUMBER ONE
Heart attack, stroke and other cardiovascular diseases have been
America's No. 1 killer since 1919. Nearly 61 million Americans--1 in
5--suffer from one or more of these diseases. Americans of all ages!
Also, hundreds of millions of Americans have major risk factors for
these diseases--about 50 million have high blood pressure, 41 million
adults have elevated blood cholesterol (240 mg/dL), 49 million adults
smoke, 107 million adults are overweight or obese and 10 million have
physician-diagnosed diabetes. As the baby boomers age, the number of
Americans afflicted by these lethal and disabling diseases will
increase substantially. Cardiovascular disease costs Americans more
than any other disease. Americans will pay an estimated $300 billion
for cardiovascular-related medical costs and lost productivity in 2001.
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 major 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.
According to an expert panel supported by this Committee, America's
progress in reducing the death rate from cardiovascular disease has
slowed, suggesting that new strategies against these killers are
needed. The panel also reported that there are striking differences in
cardiovascular death rates by race/ethnicity, socioeconomic status and
geography. But promising, cost-effective breakthroughs in treatment and
prevention are on the horizon. If you stay the course to double NIH
funding by fiscal year 2003, the support of heart and stroke research
and of the translation of that research into effective clinical and
community initiatives will cut health care costs and improve the
quality of life. For fiscal year 2002, we urge you to do the following:
--Appropriate $23.7 billion (a 16.5 percent increase over fiscal year
2001 funding) for the NIH--the fourth step toward the
bipartisan goal of doubling NIH's budget by fiscal year 2003.--
NIH research provides new treatment and prevention strategies,
cuts health care costs, creates jobs and maintains America's
status as the world leader in the biotechnology and
pharmaceutical industries.
--Provide at least a 16.5 percent increase over fiscal year 2001
funding for NIH heart and stroke research.--Researchers are on
the brink of advances to greatly enhance prevention and to
provide new treatments so you and your loved ones can be spared
the pain and suffering of heart disease and stroke.
--Allot $50 million for CDC's Cardiovascular Health Program to expand
this initiative to 35 states.--Science must be made applicable
through community programs that encourage Americans to make
healthful lifestyle choices to prevent heart disease and
stroke.
--Support $12.5 million to continue to help rural communities buy
automated external defibrillators (AEDs) and to train rural
emergency responders, including police and fire personnel, to
use them.--Rural Access to Emergency Devices Act is part of
Public Law 106-505, Public Health Improvement Act.
HEART AND STROKE RESEARCH BENEFITS ALL AMERICANS
Thanks to advances in addressing risk factors and in treating
cardiovascular diseases, more Americans are surviving heart disease and
stroke. Heart disease and stroke research and prevention breakthroughs
are saving and improving lives. Several examples follow.
--Stents.--Each year nearly 1 million Americans undergo angioplasty
to widen their narrowed arteries to the heart. But, within six
months, 35 percent of angioplasties must be repeated because
the artery narrows again. In a major change in patient care,
stents (wire mesh tubes used to prop open an artery) are now
used in nearly 80 percent of angioplasties. The use of stents
along with angioplasty has significantly reduced the incidence
of artery renarrowing within six months.
--Surgery to Reduce Risk for Stroke.--In many cases, surgeons can
prevent stroke by removing the buildup of plaque when one of
the main arteries to the brain is severely narrowed. Research
has better defined the group of patients in whom this surgery
is most helpful. About 121,000 such procedures are performed
each year.
--State-of-the-Art Life-Extending Drugs.--Research has produced
amazing new drugs to help prevent and treat heart disease and
stroke. Cutting-edge drugs to control blood pressure and
cholesterol are more effective than ever in saving lives and
enhancing life quality of millions of Americans. Some of these
drugs can prevent both heart attack and stroke. When prevention
fails, revolutionary ``clotbuster'' drugs, such as tPA, can
reduce disability from heart attack by dissolving blood clots
causing the attack. In stroke, the use of tPA, within 3 hours
of the onset of symptoms, can restore blood flow and reduce
chances of permanent disability by 33 percent, saving health
care costs. TPA offers hope for the estimated 1.1 million
Americans who will suffer a heart attack and the 450,000 who
will have a clot-based stroke this year.
So Americans can continue to benefit from these types of
breakthroughs, it is critical that we proceed toward doubling the
overall NIH budget by fiscal year 2003. We advocate an fiscal year 2002
appropriation of $23.7 billion for the NIH, the fourth step toward the
doubling goal. We have a particular interest in individual NIH
components that relate directly to our mission of reducing heart
attack, stroke and other cardiovascular diseases. Our funding
recommendations for these institutes, centers 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, more of our patients, our
families, and our friends survive their heart attack or stroke and with
a better quality of life. However, while more Americans are surviving,
heart attack and stroke are still our No. 1 and No. 3 killers,
respectively, and can cause permanent disability, requiring costly
medical care and loss of productivity and quality of life. Clearly more
work is needed if we are to win the fight against heart disease and
stroke.
We urge this Committee to double the NHLBI budget, including heart
initiatives, by fiscal year 2003. As the next step toward reaching this
goal, we advocate an fiscal year 2002 appropriation of $2.679 billion
for the NHLBI, with $1.650 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.
--Advanced Imaging.--Research has revolutionized imaging technology
to diagnose heart disease. About 1.3 million Americans in 1998
were hospitalized for an angiogram, an X-ray picture of blood
vessels that can demonstrate narrowings in arteries that can
lead to heart attacks or strokes. Because angiograms are
associated with some discomfort, the risk of infection and
bleeding, and in rare cases, heart attack or stroke; there is
strong motivation to replace them with easier, safer and
cheaper imaging procedures. Considerable progress has been
made. The high speed CT scan takes pictures that produce a
measure of blockages in arteries to the heart, and helps
doctors better tailor treatments. Three-dimensional coronary
magnetic resonance angiography uses strong magnets to provide
detailed images of the arteries to the heart. In less than an
hour, an MRA evaluates heart anatomy and other heart functions,
providing an accurate and thorough, non-invasive examination.
--Bone Formation and Calcification in Cardiovascular Diseases.--
Calcium is an early marker of atherosclerosis involving the
arterial wall. Evidence suggests an association between bone
formation, repair and breakdown (e.g. osteoporosis) and
development of heart disease and other cardiovascular diseases.
For instance, patients who take statin drugs--effective in
lowering cholesterol levels and in reducing cardiovascular
disease risk--are at decreased risk for bone fractures.
Conversely, several studies have reported that people with low
bone mass may have an increased risk of developing or dying
from cardiovascular diseases. These results indicate that basic
research in this area may result in strategies to prevent
osteoporosis and cardiovascular diseases.
--Heart Attack, Stroke and Other Cardiovascular Diseases in Women.--
Cardiovascular diseases are a major cause of disability and the
No. 1 killer of American women, killing more women than the
next 14 causes of death combined. About 1 in 5 women live with
effects of cardiovascular diseases. The clinical course of
cardiovascular disease is different in women than in men and
our diagnostic capabilities are less accurate in women than in
men. After a woman develops cardiovascular disease, she is more
likely than a man to have continuing health problems and is
more likely to die. But these diseases are largely unrecognized
by both women and their doctors. Extra funding is needed to
allow NHLBI to expand cardiovascular disease research in women
and to create more educational programs for patients and health
care providers on cardiovascular diseases risk factors, as
authorized under Public Law 105-340, Women's Health Research
and Prevention Amendments.
--Resuscitation Research.--Some 1,000 Americans die each day from
unsuccessful cardiopulmonary and trauma resuscitation. The
National Heart, Lung, and Blood Institute, the National
Institute of Neurological Disorders and Stroke, the National
Institute of Child Health and Human Development, the National
Institute of General Medical Sciences, the Department of
Defense, and the Food and Drug Administration sponsored a forum
to set a broad research agenda on promising and novel life-
saving therapies and to identify promising new directions in
CPR and trauma resuscitation research.
STROKE RESEARCH CHALLENGES AND OPPORTUNITIES FOR NINDS
A major cause of permanent disability and a key contributor to
late-life dementia, stroke is America's No. 3 killer. Many of our 4.5
million stroke survivors face debilitating physical and mental
impairment, emotional distress and huge medical costs. About 600,000
Americans will suffer a stroke this year. Considered a disease of the
elderly, stroke also strikes newborns, children and young adults.
We urge a doubling of the NINDS stroke budget by fiscal year 2003.
An fiscal year 2002 appropriation of $1.371 billion for NINDS, with
$151 million for stroke initiatives, would be the next step toward the
goal. This will allow the NINDS to expand studies and start new
initiatives to prevent stroke, protect the brain during stroke and
enhance rehabilitation. Some challenges and opportunities follow.
--Strategic Stroke Research Plan.--As a result of report language
provided by this Committee during the fiscal year 2001
appropriations process, NINDS is developing a 5-year strategic
stroke research plan. Researchers, clinicians, pertinent
organizations and advocacy groups will identify existing gaps
in knowledge and areas ripe for advances. Expected to be
released in fall 2001, the plan will strongly stimulate stroke
research.
--Emerging Stroke Risk Factors.--More 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. Scientists are defining new stroke risk factors, re-
examining existing ones and reconsidering the long-held belief
that no difference exists in risk between young and older
patients with similar risk factors. Researchers are studying
heart valve disease, irregular heartbeats, the role of
inflammation in clogging of arteries, and the long-term effects
of previous high blood pressure. Increased funding to study
these areas may lead to new ways to prevent stroke.
--Therapeutic Strategies for Stroke.--Several major clinical trials
have identified new methods for preventing and treating stroke
in high-risk populations. However, with the increased number of
strokes, and with the disparities evident in the treatment of
stroke, new ways to prevent strokes, to raise awareness, and to
better treat strokes need to be developed and evaluated.
Funding for new clinical studies is crucial for developing
cutting-edge stroke treatment and prevention.
--Stroke Education.--Less than 5 percent of those eligible for tPa--
the only approved emergency treatment for clot-based stroke--
receive it. As a member of the Brain Attack Coalition,
comprised of organizations committed to fighting stroke, we
work with the NINDS to increase public awareness of stroke
symptoms and to call 9-1-1. Together, we sponsor and distribute
a televised public service announcement and are striving to
develop systems to make tPA readily available to appropriate
patients. When these measures are fully implemented, stroke
treatment will change from supportive care to early brain-
saving intervention. More funding is needed to educate the
public and health professionals about stroke.
research in other nih institutes benefit heart & stroke
The 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 2002 appropriation of $80.675
million for cardiovascular research will allow continuation of studies
and expansion into promising areas of investigation.
The National Institute of Diabetes and Digestive and Kidney
Diseases studies help in reducing cardiovascular disease death and
disability. We advocate an fiscal year 2002 appropriation of $1.548
billion for the NIDDK to advance research to help diabetics, 2/3 of
whom die from heart disease or stroke.
The National Institute of Nursing Research studies play a key role
in promoting self-care and patient education. NINR research is key to
primary and secondary prevention of heart attack, stroke and other
cardiovascular diseases. We advocate an fiscal year 2002 appropriation
of $121.591 million for NINR.
Animal research and nationally-supported clinical research at the
local level are critical for heart and stroke research. We support an
appropriation of $952.358 million for the National Center for Research
Resources. Increased resources will fortify animal research, help
correct deficiencies in animal research resources and strengthen
nationwide General Clinical Research Centers and Biomedical Technology
and Infrastructure Areas.
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
The lead health care quality agency, AHRQ acts as a ``science
partner'' with public and private health care sectors in improving
health care quality, reducing health care costs and broadening access
to essential services. 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 advocate an
appropriation of $400 million for the AHRQ to improve health care
quality, reduce medical errors and expand the availability of health
outcomes information.
CENTERS FOR DISEASE CONTROL AND PREVENTION
Prevention is the best way to protect Americans' heath and ease the
huge financial burden of disease. Commitment cannot stop at the
laboratory door. Resources must be made available to bring research to
places where heart disease and stroke live--the towns and neighborhoods
of America.
CDC sets the pace on prevention. It builds a bridge between what we
learn in the lab and how we live in communities. We advocate an fiscal
year 2002 appropriation of $5 billion for CDC, with a $350 million
increase for chronic disease prevention.
As a result of this Committee's support since fiscal year 1998,
CDC's Cardiovascular Health Program now covers 25 states. It allows
states to design and/or implement programs to meet local needs to
prevent and control heart disease and stroke. CDC's 1997 report
Unrealized Prevention Opportunities: Reducing the Health and Economic
Burden of Chronic Disease states ``strong chronic disease prevention
programs should be in place in every state to target the leading causes
of death and disability--and their risk factors.'' Until this Committee
started the Cardiovascular Health Program, CDC's 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 each
state. An fiscal year 2002 appropriation of $50 million for the
Cardiovascular Health Program will allow CDC to expand it to 10 more
states, to total 35 states.
The Paul Coverdell National Acute Stroke Registry is designed to
track and improve delivery of care to stroke patients. CDC is working
with an expert panel to define data points for the registry prototypes.
An appropriation of $5 million for the registry will allow CDC to
continue this initiative.
WISEWOMAN builds on CDC's National Breast and Cervical Cancer Early
Detection Program to also screen uninsured and low-income women ages
40-64 for heart disease and stroke risk factors. We laud this Committee
for providing funding to expand this program up to 15 states. An
appropriation of $20 million will allow CDC to support up to a total of
20 states in WISEWOMAN.
Also, we recommend the following fiscal year 2002 funding levels
for the following CDC programs:
--$210 million for the Preventive Health and Health Services Block
Grant;
--$50 million for an extensive nutrition, physical activity and
obesity program;
--$35 million for a comprehensive school health education program;
and
--$130 million for CDC's Office of Smoking and Health to build a
national program to prevent tobacco use, including a public
education campaign to reduce youth access to tobacco products.
Coupled with a nationwide comprehensive Cardiovascular Health
Program, these initiatives will help the fight against heart disease
and stroke. We urge you to make cardiovascular health a priority.
HEALTH RESOURCES AND SERVICES ADMINISTRATION
About 220,000 Americans die each year from sudden cardiac death--
when a heart's electrical rhythms malfunction, causing the heart to
suddenly stop beating. Only about 5 percent of the victims live. Small,
easy-to-use devices, AEDs can shock a heart back into normal rhythm and
restore life. For each minute the heart beat is not restored to its
normal rhythm, the victim's chance of survival drops as much as 10
percent. The first responder to a cardiac arrest may not be a medical
responder, so the Rural Access to Emergency Devices Act, part of Public
Law 106-505, Public Health Improvement Act, authorizes up to $25
million over 3 years to help rural communities buy AEDs and to train
emergency responders to use them. An appropriation of $12.5 million is
needed to further implement the rural AED component.
DEPARTMENT OF EDUCATION
Physical inactivity is a major risk factor for heart disease and
stroke. So the grim decline in daily enrollment in physical education
(PE) classes is a key concern. To address this matter, in fiscal year
2001 Congress appropriated $5 million for the Physical Education for
Progress Act. Under PEP, the Education Secretary can award grants to
start, expand and improve PE for kindergarten through grade 12. Funds
can be used to buy equipment, develop curriculum, hire and/or train
staff and support other efforts so students can participate in PE. We
advocate an appropriation of $70 million for PEP in fiscal year 2002.
ACTION NEEDED
Significantly increasing funding for research and community
programs will allow us to continue making strides in the battle against
heart disease and stroke. Our government's response to this challenge
will help define the health and well being of Americans in this new
millennium.
______
Prepared Statement of the American Psychological Society
SUMMARY OF RECOMMENDATIONS
As a member of the Ad Hoc Group for Medical Research Funding, APS
recommends $23.7 billion for NIH in fiscal year 2002 as the 4th
installment of the 5-year doubling plan.
APS requests Committee support for increased behavioral and social
science research and training at NIH in order: to better meet the
Nation's health needs--many of which are behavioral in nature; to
realize the exciting scientific opportunities in the fields of
behavioral and social science research; and to accommodate the changing
nature of science, in which new fields and new frontiers of inquiry are
rapidly emerging. Specifically, we ask that you help make behavioral
research more of a priority at NIH, both by providing maximum funding
for those institutes where behavioral science is a core activity, and
by encouraging NIH to advance a model of health that includes behavior
in deciding its scientific priorities.
Specific Committee support is requested for behavioral science
activities at a number of individual institutes and examples are
provided to illustrate the exciting and important behavioral and social
science work being supported at NIH.
Mr. Chairman, Members of the Committee: On behalf of our members, I
want to thank this committee for your leadership in the bipartisan
effort to double the NIH budget. As a member of the Ad Hoc Group for
Medical Research Funding, the American Psychological Society recommends
$23.7 billion for NIH in fiscal year 2002 as the 4th installment of the
5-year doubling plan. The rationale for these aggressive increases
remains as compelling today as it was in fiscal year 1999, the first
year that you and your colleagues in the House embarked on this path.
Our Nation's health needs, scientific opportunities, and the changing
nature of health research all warrant this expansion. I will talk about
these three areas in terms of the field that I represent, which is
behavioral and social science research--specifically, psychological
science research.
Health Needs.--The effects of behavior on health have been widely
documented. Behavior is as threatening as any genetic or biological
condition. When you look at what determines health, you can't help but
notice behavior. Smoking, drinking, taking drugs--all begin as
behaviors. And many other leading health concerns are behavioral in
origin or in their manifestation: Heart disease, lung disease,
diabetes, mental illness, developmental disabilities, brain injury,
AIDS, and so many more cannot be fully understood without studying the
behavioral and psychological factors involved in causing, treating and
preventing them.
Scientific Opportunities.--Many of the 15,000 people who belong to
APS are scientists at our Nation's leading universities and colleges,
conducting research and training supported by NIH. The behavioral
research enterprise at NIH spans from theoretical to applied, from
basic to clinical. Virtually every institute at NIH supports some
amount of psychological science. Examples include investigations into:
The connections between the brain and behavior; the basic processes of
cognition and memory; social interaction in people of all ages; the
interactions of such things as emotion, stress, and psychophysiology
and their impact on health; research into how children grow and
develop; management of debilitating chronic conditions such as diabetes
and arthritis as well as depression and other mental disorders; and the
behavioral aspects of smoking and drug and alcohol abuse, to find ways
people can escape addiction. These topics represent some of the most
exciting research frontiers today, and our field is poised to make
significant strides in a number of scientific areas that a few years
ago didn't even exist.
Changes in the Nature of Research.--If we didn't know it before,
the recent publicity surrounding the sequencing of the human genome has
hit home the notion that we are in a new era of science. In the flurry
of interviews and opinion pieces that followed the recent publication
of human genome research articles, leaders of the human genome projects
and other scientists have repeatedly stressed that genes alone cannot
explain complex behavior or account for all risks for developing a
particular physical or mental illness or for behavioral problems. They
consistently caution against the notion that genes determine behavior.
As noted by Robert Plomin, a distinguished APS Fellow and pioneer in
the field of behavioral genetics, the influence of genes on behavior is
``probabilistic, not deterministic.''
The implications of mapping the human genome are enormous for
psychological research. Psychologists and other behavioral scientists
already are asking such questions as: How do the effects of specific
genes unfold in behavioral development? How do they interact with
experience and other environmental factors? In other words, now that we
have genes, how do they work?
As just one example of what I mean, psychologists soon may be able
to use genes to better target behavioral interventions to the people
who need them most--to tailor our interventions to those at highest
genetic risk. For example, if we learn that certain genes put children
at risk for behavioral disorders, say anorexia, depression, or even for
diabetes, then those are the children for whom we need to develop
specific prevention strategies. For diabetes, this may mean a much more
aggressive approach to diet, weight control, and a program to maintain
compliance with taking medication, an often-ignored but critically
important and totally behavioral part of managing a disease. What this
requires, however, is that at the same time we are trying to understand
how genes influence behavior, we need to more systematically study the
behavior itself and use that information to develop more targeted
interventions.
The emergence of fields such as behavioral genetics draws from the
progress made both in genetics and behavioral research, and illustrates
the seamless connection between behavior and biology--a continuum we
would like to see NIH promote more than it does now. Cognitive
neuroscience, the combined approach of mapping the brain's
psychological functioning onto its physical and biological functioning,
is another such area. Unfortunately, NIH's research and training
policies sometimes make it appear as if there is an artificial
distinction between the behavior and biology. There is excellent
behavioral science work being done at NIH, producing quality knowledge
and breakthroughs that should be a source of enormous pride for NIH.
But too often in the NIH model, behavior is ignored, particularly basic
behavioral research. It isn't until a person gets lung cancer,
emphysema, heart disease, liver damage, brain damage, that behavior is
thought of. As important as the molecular and cellular origins of these
problems are, the behavioral origins are equally important. For
example, how do the basics of learning, memory, perception, emotion, or
even social development interact with the biology of various diseases?
The answer is, there is a great deal of interaction among these
factors. Almost none of the disorders NIH addresses can be fully
understood without also understanding their behavioral dimensions.
Mr. Chairman, I ask you and the Committee to give your fullest
consideration to these concerns as part of your deliberations on the
fiscal year 2002 budget for NIH. Specifically, we ask that you help
make behavioral research more of a priority at NIH, both by providing
maximum funding for those institutes where behavioral science is a core
activity, and by encouraging NIH to advance a model of health that
includes behavior in deciding its scientific priorities.
Training: A Return on the Investment.--When discussing the budget
for NIH and other federally-funded science agencies, we often talk in
terms of investment--putting money into activities where the return
will be realized somewhere down the road. In providing research grants,
sometimes we don't know when or even whether there will be a
significant payoff--we have an extensive review system that helps
minimize the likelihood of a washout, but still, the outcomes of
science are unpredictable.
One part of science where the investment is almost guaranteed to
payoff is in the area of training. We know that if we provide support
now for a young investigator, we will have a well-trained, highly-
qualified scientist as a result. We also know that without training, we
will not have an adequate pool of researchers to pick up where
preceding generations leave off. Supply is a critical issue in
behavioral science at NIH. Right now, NIH institutes are competing for
a comparatively small pool of behavioral science researchers. In fact,
we are seeing some institutes with new or expanding behavioral science
programs enticing senior behavioral grantees from sister institutes,
leaving the ``old'' institutes with critical gaps in their portfolios.
To address this problem, institutes need to ``grow their own''--the
responsibility for training behavioral scientists should be shared
across all of the institutes because of the role of behavior in
virtually all of the major health issues being addressed by NIH. Toward
this end, several institutes have established B/START (Behavioral
Science Track Awards for Rapid Transition) programs of small grants to
encourage newer behavioral science investigators. This has proved to be
an effective mechanism and should be used across NIH.
But training shouldn't be just an issue of supply and demand. As I
noted earlier, health needs should be the most important factor in
determining our research and training priorities. In behavioral and
social science research, training is essential not only to ensure
future supply of scientists, but also to ensure that our Nation's best
minds are working on the issues that are most directly linked to
health.
Dozens of reports from the National Research Council and the
Institute of Medicine have recommended increased training for health
and behavior research. One such report, Bridging Disciplines in the
Brain, Behavioral and Clinical Sciences, notes that ``newly emerging
health problems, as well as those that have plagued us over time, are
proving to be surprisingly complex as scientists and health care
providers begin to recognize the intricate interplay among environment,
behavior and disease.'' The report adds that this is ``driving
disciplines toward each other'' and that ``the next generation of
scientists must be prepared to integrate the advances of rapidly
progressing disciplines.'' The report nicely complements the changes in
the nature of research that I highlighted above.
Meeting the future needs of research in health and behavior means
NIH must have a comprehensive training strategy today, a strategy that
focuses on training young investigators in the core disciplines of
behavioral and social science research as well as in the
multidisciplinary perspectives alluded to in the NRC report and
elsewhere. In addition to encouraging behavioral science training at
individual institutes, NIH needs an overall plan that will minimize
unnecessary duplication and will establish an appropriate behavioral
science training enterprise that can serve the needs that exist
throughout NIH's institutes and offices.
We ask the Committee to support the development, in consultation
with the relevant scientific community, of a comprehensive training
strategy for behavioral and social science research at NIH. This
strategy should include all training mechanisms, and should be balanced
between interdisciplinary research and traditional core disciplines in
the behavioral sciences.
National Institute of Mental Health (NIMH).--Translational
Research--In an effort to more closely link basic and clinical research
in behavioral science, NIMH is implementing an institute-wide plan to
expand its ``translational research'' activities that are intended to
bring knowledge from the lab into practice, and for practice to
influence what occurs in the laboratory. Responding to recommendations
from a report conducted under the auspices of its national advisory
council, NIMH is stimulating new connections between basic and clinical
research through such mechanisms as: Requests for Application (RFAs);
providing greater access to clinical populations and collaborators;
workshops connecting basic researchers with public health and clinical
investigators; and new peer review procedures that draw on experts from
both clinical and basic perspectives. NIMH is also considering support
for translational research centers in behavioral science.
Basic Behavioral Research.--We applaud NIMH for its efforts to
promote the transfer of knowledge into application. But basic
behavioral research at NIMH must continue to receive the same strong
support it traditionally receives there. This is important not only to
ensure the foundation of basic knowledge in mental health, but also
because NIMH is a de facto source of basic behavioral knowledge that is
tapped by many other institutes. Until other institutes begin to
support larger amounts of basic behavioral science research connected
to their mission, it is essential that NIMH's programs of research into
behavioral phenomena such as cognition, emotion, psychopathology,
perception, development, and others continues to flourish.
We ask the Committee to encourage NIMH's continued efforts to
strengthen the ties between basic and clinical behavioral research, and
to encourage NIMH's basic behavioral science portfolio in order to
ensure continued progress in our understanding of the causes,
treatment, and prevention of mental illness and the promotion of mental
health.
National Institute on Drug Abuse (NIDA).--NIDA's dramatic progress
in addressing the Nation's drug problems (many of which are behavioral
in nature) has been accompanied by a broadening of its behavioral
science portfolio. Under the leadership of psychologist Alan I.
Leshner, NIDA has launched a widescale Clinical Trials Network (CTN) to
test drug treatment strategies that have proven effective under
controlled research conditions. Most of the interventions currently
being tested are based on behavioral treatments, since those have been
found to be effective. The CTN was recommended by the 1998 Institute of
Medicine report, Bridging the Gap Between Research and Practice, as the
single mechanism most likely to improve drug abuse treatment in this
country. Given the enormous promise of this initiative to improve the
Nation's drug treatment programs and the urgency of the Nation's public
health problems associated with drug abuse and addiction, we ask the
Committee to increase funds for NIDA's Clinical Trials Network in
fiscal year 2002.
In addition to the Clinical Trials Network, NIDA's basic behavioral
research helps treatment providers better understand and address the
dynamics of addiction. NIDA is placing special emphasis on cognitive
research because processes such as learning, memory, decision-making,
and other cognitive factors play a central role in virtually every
aspect of drug abuse and addiction, including vulnerability, craving,
relapse, self-regulation, and treatment. The knowledge from NIDA's
basic behavioral science research has enormous potential for reducing
demand for drugs at the individual, family and community levels. We ask
this Committee to increase NIDA's budget as part of an overall policy
of creating a more balanced and effective drug control strategy for the
Nation.
National Institute on Alcohol Abuse and Alcoholism (NIAAA).--
College-age drinking and underage drinking are two behavioral topics of
enormous concern to the Nation's universities, parents, and
communities. A subcommittee of the NIAAA national advisory council is
completing a report addressing various aspects of campus drinking. The
report, being developed jointly by alcohol researchers and college
presidents, describes the scope of the problem, examines the
effectiveness of current interventions, and will recommend priorities
for developing effective, science-based interventions to reduce college
drinking.
NIAAA has made substantial efforts to broaden its behavioral
science portfolio to understand the underlying psychological and
cognitive processes that lead people to drink, and the impact of
chronic alcohol abuse on those processes. As one example, NIAAA
convened a workshop of national experts on social identification and
alcohol research to examine ways that peer pressure in groups and group
norms concerning drinking may influence drinking behaviors. More
recently, the institute convened a group of experts in cognitive
research to explore the effects of alcohol abuse on memory, decision-
making, cognitive development, in order to begin looking at issues of
cognitive rehabilitation.
Understanding the behavioral origins and manifestations of problem
drinking and addiction is the key to addressing the Nation's epidemic
of alcohol-related behavioral health problems, which range from brain
disease to drunk driving. We ask Congress to increase NIAAA's budget in
fiscal year 2002 in order to reduce the Nation's alcohol-related health
problems.
National Institute of General Medical Sciences (NIGMS).--NIGMS is
the only national institute specifically mandated to support research
not targeted to specific diseases or disorders. NIGMS does not now
support basic behavioral science research, despite the wide range of
fundamental behavioral topics with relevance to a variety of diseases
and health conditions. The lack of behavioral science research at NIGMS
represents is an enormous gap, given the basic behavioral research and
training that NIGMS should be supporting. Congress addressed this issue
for the past two years in appropriations reports on the fiscal year
2000 and fiscal year 2001 budgets for NIH. Specifically, you said:
``There is a range of basic behavioral research and training that the
Institute could support, such as the fundamental relationships between
the brain and behavior, basic cognitive processes such as motivation,
learning and information processing, and the connections between mental
processes and health. The Committee encourages NIGMS to support basic
behavioral research and training, and to consult with the behavioral
science research community and other Institutes to identify priority
research and training areas.'' NIGMS has not responded to your
requests. We continue to believe strongly that NIGMS should develop a
basic behavioral science research program. Accordingly, we ask the
Committee to direct NIGMS to develop a plan for basic behavioral
science research at NIGMS.
National Cancer Institute (NCI).--NCI has expanded its commitment
to behavioral research in a comprehensive program that ranges from
basic behavioral science to research on the development, testing and
dissemination of disease prevention and health promotion interventions
in areas such as tobacco use, diet, and even sun protection.
Recognizing the central role of effective communication in addressing
issues of health and behavior, NCI has also undertaken a major effort
to develop science-based communications strategies for disseminating
information and persuasive messages about cancer prevention and
treatment to the public. These messages draw from a foundation of basic
behavioral and social science research into such issues as how people
learn and remember health information, how they perceive health risks,
and how they are persuaded to adopt healthy behaviors.
One of NCI's scientific priorities in fiscal year 2002 is tobacco-
related research. A significant portion of this initiative is devoted
to behavioral and social science research into such topics as
identifying populations at risk for tobacco use, formulating effective
prevention and quitting strategies, and capitalizing on legal, social
and public policy developments on tobacco use and addiction.
Other basic behavioral research programs include research to
develop theoretical models, identify underlying mechanisms of behavior
change, and to develop and test science-based interventions. For
example, NCI supports research that examines how stress and
psychosocial influences on behavior, the central nervous system, the
immune system, and CNS-immune system interactions affect the
progression and remission of cancer. Other examples include research
into the psychophysiological and genetic processes involved in health
behaviors, and the psychosocial and behavioral consequences of cancer
risk assessment, including the impact of genetic testing on the
individual and the family.
NCI's behavioral research program also supports health promotion
research, including behavioral science relating to cancer prevention
and program evaluation. We ask Congress to support NCI's expanded
behavioral science research and training initiatives.
National Institute on Aging (NIA).--NIA is a major supporter of
behavioral and social science research. NIA has reorganized its
behavioral and social science programs in order to respond to--and
create--new opportunities in the study of aging processes, how older
people function in society, and how people change with aging. NIA also
looks at the social institutions such as family and the health care
system in terms of their impact on the health of older people. Areas of
emphasis in NIA's behavioral and social science programs include health
disparities, aging minds, health expectancy, health, work and
retirement, behavior change, and the interplay among genetics,
behavior, and social environment. NIA also supports a significant
amount of research in cognitive functioning in its neuroscience and
neuropsychology program, which looks at the effects of aging on memory
and other brain-based behavioral functioning. We ask the Committee to
support NIA's commitment to behavioral and social science research on
aging.
National Institute on Child Health and Human Development.--Child
development involves some of the most complex and important questions
facing behavioral and social science researchers. Understanding the
interplay among behavior, social and physical environment, and biology
is central to discovering ways to prevent behavior-based health
problems ranging from fetal alcohol syndrome to teen pregnancy to
violence. NICHD's Child Development and Behavior Branch supports
research on the cognitive, social, and emotional development of
children from newborns to adolescents. We are concerned that NICHD has
received a below-average share of NIH's budget increases in the past
few years; what this conveys, whether intended or not, is that
children's issues have lower priority in health research. We hope you
will send a strong counter-message this year, and allow NICHD to
enhance its child development portfolio. We ask the Committee to
allocate the necessary resources in fiscal year 2002 to allow NICHD to
fulfill its mission in these areas.
On a related topic, NICHD has been supporting the Study of Early
Child Care and Youth Development, the most comprehensive study to date
of child care experiences and characteristics and developmental
outcomes. NICHD is now sharing the rich body of data from the study
with other qualified researchers in order to allow an even greater
number of researchers to explore issues around child care, including
those that may affect child development. We ask the Committee to
support this study and NICHD's data-sharing initiative.
NIH Office of Behavioral and Social Sciences Research (OBSSR).--We
ask the Committee to welcome Raynard Kington as the new director of
OBSSR, and to encourage him, as he contributes his expertise to NIH's
``Health Disparities'' initiative, to ensure that the full spectrum of
behavioral and social science research be brought to bear on this
important topic as well as on the other initiatives that are within
OBSSR's purview.
Communication Disorders, Visual Perception, Diabetes, Brain and
Behavior.--Although space doesn't permit me to describe fully some of
the other behavioral science activities across NIH, I want to note the
impressive behavioral science work being done in such areas as
communication disorders, visual perception, diabetes, and brain
research, all of which merits the encouragement and support of this
Committee. We ask that in fiscal year 2002, support be given to
expanding the behavioral science research and training programs at
institutes where this important work is being done.
This concludes my testimony--I would be pleased to answer your
questions or provide additional information.
______
Prepared Statement of the American Society of Clinical Oncology
The American Society of Clinical Oncology (ASCO) represents more
than 16,000 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 2002 appropriations for the
National Institutes of Health (NIH) and the National Cancer Institute
(NCI), as well as other issues related to the missions of NIH and NCI.
These matters are of great importance to clinical researchers,
physicians, and their patients.
FISCAL YEAR 2002 APPROPRIATIONS FOR NIH AND NCI
ASCO applauds the commitment of this Subcommittee and the
outstanding leadership of Chairman Arlen Specter and Ranking Member Tom
Harkin to doubling the budget for NIH between 1999 and 2003. This
panel's commitment has been essential to ensuring predictability and
stability in NIH funding and allowing scientists to pursue exciting new
research endeavors. We believe the biomedical research effort of this
country is so strong largely because of the unwavering support of
Congress.
As you know, sustaining progress toward the goal of doubling the
NIH budget by 2003 requires a funding boost of 16.5 percent in 2002. We
greatly appreciate the budget amendment sponsored by the Chairman and
Ranking Member to achieve this effort. We strongly support a 16.5
percent increase for NIH and will work with you toward that goal.
In addition, we recommend that funding for NCI be enhanced in
accordance with the Institute's plan and budget proposal for fiscal
year 2002 ( the ``Bypass Budget''). As directed by Congress in the
National Cancer Act of 1971, each year the NCI delivers a ``bypass''
budget directly to the President. This process was implemented to
ensure that the President and Congress directly receive NCI's
scientific recommendations on the best way to appropriate funds to
build on research successes, support the cancer research workforce, and
ensure that recent discoveries are translated into improved patient
care. For fiscal year 2002, the NCI recommends funding of $5.03
billion, an increase of $1.27 billion. Funding NCI at this level 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
$5.03 billion, and we urge the Subcommittee to begin the new millennium
by implementing this carefully considered budget proposal.
FUNDING FOR CLINICAL TRIALS OPERATION
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.
NCI provides essential support for cancer clinical research. NCI-
sponsored trials represent at least half of all cancer trials.
Unfortunately, NCI does not provide adequate funding to support the
grants they award. ASCO funded three surveys in September 1998 to
examine (1) oncologists' experiences and perceptions associated with
clinical trial participation; (2) pharmaceutical industry participation
in clinical trials; and (3) the costs associated with conducting
clinical trials. The surveys indicated that physicians prefer to
participate in NCI trials, especially those conducted through the
cooperative cancer groups. They report that these trials are
exceptionally well designed, respond to the critical goals of oncology,
and are intellectually challenging. Participating in these trials,
however, amounts to an act of good will, since physicians lose money on
every NCI trial they conduct.
Conducting a clinical trial requires tremendous resources for a
physician practice. These resources include trained research nurses and
data managers and the computer equipment needed to compile and analyze
the data. In fact, it takes 15 separate activities to enroll patients
and conduct a clinical trial. The most time-consuming of these
activities include recruiting patients, seeing patients in the
physician's office, and completing forms. Overall, 200 hours of work
are required to see one patient through the clinical trial process. Our
1998 survey found that the average cost to enroll a patient in a
clinical trial is $2,000 per patient. Current NCI reimbursement is
$1,500 per patient.
Our ability to find better cancer treatments and improved
understanding of this dreadful disease are inextricably linked to a
thriving clinical research network. Without proper reimbursement,
physicians will be pressed to devote less time to clinical research--
especially with the pressure that managed care is placing on practices
to seek higher reimbursements. If trials are adequately funded and
supported, we could shorten the length of time it takes to complete
patient accrual--thus quickening the time it takes to complete research
and improve patient care. We will not reap the full rewards of our
increased investment in NIH and NCI unless we provide adequate support
to the physicians who are conducting clinical trials.
CLINICAL RESEARCH STUDY SECTION
Investigator-initiated clinical research proposals have not fared
well historically at NIH because they have been reviewed by basic
researchers who are not well versed in patient-oriented research. ASCO
has maintained that allowing the proportion of reviewers for such
patient-oriented research proposals to be dominated by basic
researchers is inequitable, a position endorsed by several blue ribbon
panels charged with oversight of the NIH peer review process.
Furthermore, physician scientists' success in obtaining NIH funding for
investigator-initiated research has a significant impact on their
willingness to remain in the field, according to reports. Therefore,
the research review process has a significant impact on today's
clinical research and on the future of patient care.
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 (SEP) to review
clinical oncology research proposals. The Clinical Oncology (CONC) SEP
is composed of clinical researchers who have the expertise and
experience to evaluate cancer clinical research proposals. We are
pleased that a number of clinical oncologists sit on the CONC SEP, and
reports on its work have been positive. We are also pleased that CSR is
currently in the process of making the CONC SEP into a permanent study
section. We believe this will result in a system of fair and informed
review of clinical oncology research.
Through this transition and the larger CSR transformation of the
Integrative Review Group (IRG) system, we remain chiefly concerned that
clinical oncology research proposals are reviewed by committee members
with expertise in patient-oriented research. External NIH advisors have
consistently recommended that NIH avoid a review process where basic
researchers dominate the review of patient-oriented research proposals.
A majority of the membership of panels reviewing clinical research
should have experience in reviewing and/or conducting patient-oriented
research. ASCO urges the Subcommittee to renew its directive to NIH
officials to maintain a peer review system that has researchers with
patient-oriented research expertise making up the majority of
researchers reviewing cancer clinical research proposals. The
Subcommittee's involvement will be particularly timely, as CSR is
currently in the process of appointing steering committees and study
teams to begin work on organizing the Oncological Sciences IRG in the
coming months. ASCO believes that a rigorous peer review system is
fundamental to a strong clinical research effort.
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. We are pleased that President Clinton responded to our
decade-long legislative effort by issuing an Executive Memorandum last
year that provides Medicare coverage of the routine patient care costs
of those enrolled in trials. The new Medicare policy lays the
groundwork for increasing seniors' participation in clinical trials--
thereby improving their access to state-of-the-art care and speeding
the translation of research discoveries into effective patient
treatments.
We are continuing our work to ensure that enrollees of private-
sector health plans have access to this same quality cancer care. 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 American Society of Clinical Pathologists
The United States is approaching a serious shortage of medical
laboratory personnel. The vacancy rates for seven of ten key laboratory
medicine positions is at an all time high.
Vacancy rates for cytotechnologists, the professionals who
interpret cellular material such as Pap smears, and histotechnologists,
the individuals who prepare tissue specimens, are at a disturbing high
of over 20 percent. This is a cause for immediate concern as some
laboratories will not have the appropriate personnel available to
evaluate Pap smears or prepare biopsies.
The American Society of Clinical Pathologists' Board of Registry,
in conjunction with MORPACE International, Inc., Detroit, conducts a
biennial wage and vacancy survey of 2,500 medical laboratory managers.
The survey measures the vacancy rates for 10 medical laboratory
positions, and compares and contrasts these data with that from 1988,
1990, 1992, 1994, 1996, and 1998 studies. The data for 2000 was
published in March 2001, and this statement gives a glimpse of what was
found.
Vacancy rates for cytotechnologists in the northeast average 45
percent, 16.7 percent for the east north central, and 33.3 percent for
the far west. Rural areas average a 20 percent vacancy rate for
cytotechnologists, and large cities a rather surprising 28.3 percent
rate.
Private reference laboratories have an average vacancy rate of 20
percent for histotechnologists, and hospitals have a 37.7 percent
shortage of the same profession. The west south central region of the
country has a 73.7 percent vacancy rate for histotechnologists, and the
south central Atlantic states have an average vacancy rate of 16.7
percent.
By comparison, the vacancy rate for medical technologists will not
appear to be of concern, but it too is reason for concern. Medical
technologist vacancy rate averages 11.1 percent, but rural areas show
21.1 percent vacancy and hospitals with 100-299 beds have a rate of
17.6 percent.
MEDICAL LABORATORY PROGRAMS
One of the logical solutions to this vacancy rate problem is to
train more students; however, the number of programs are decreasing.
According to the ``Health Professions Education Directory''
published by the American Medical Association, the number of medical
technology programs decreased from 383 in 1994 to 273 in 1999. The
number of graduates in medical technology has similarly decreased from
3563 in 1994 to 2491 in 1999, a 30 percent decline in five years.
ASSESSMENT
There are several reasons why the vacancy rate is increasing and
the number of program enrollees is decreasing. A number of available
positions are outside the traditional clinical laboratory. Some program
directors have reported that graduates are gaining employment in
laboratory information systems companies, ``dot.coms,'' and
corporations that manufacture or distribute diagnostic reagents,
supplies or equipment. With limited resources, hospitals have merged,
thus decreasing the availability of training sites for medical
laboratory programs. Some programs have responded by increasing access
to other laboratory training sites, such as forensics laboratories,
blood centers, physician offices, and outpatient clinics. Yet, with
these shifts, the continued demand for laboratory services is real and
is expected to grow.
In Pennsylvania, according to the Bureau of the Census, the
population is projected to grow by 3 percent by 2020, and the
population over age 65 is projected to grow by 24 percent in the same
time period. In Iowa, the population is projected to grow by 4 percent
by 2020, and the population over age 65 is projected to grow by 37
percent in the same time period.
Given the country's aging population, the number and complexity of
biopsy specimens and the use of molecular techniques will likely
increase during the next decade. Laboratory professionals who entered
the workforce in the 1960s and 1970s will be retiring soon. Also, the
threat of bioterrorism calls for trained laboratory professionals to
respond. The laboratory-allied health workforce will need to be able to
react accordingly with appropriate numbers of trained and educated
personnel.
SOLUTIONS
There are solutions to these problems. There are grants available
to help attract laboratory professionals to the field, especially
minorities and individuals in rural and underserved communities. The
Allied Health Project Grants program, administered by the Health
Resources and Services Administration, has been successful in
effectively attracting new allied health professionals into the
laboratory field.
For example, the University of Nebraska Medical Center established
medical technology education sites in four communities in rural
Nebraska, including a student laboratory in central Nebraska, under an
Allied Health Project Grant. As of 1999, of 69 graduates, 99 percent
took their first job in a rural community, and 74 percent took their
first job in rural Nebraska.
The grants are also designed to create successful minority
recruiting and retention programs for medical technologists. This was
the focus of a University of Maryland, Baltimore project initiated by
allied health grant funding in 1991. Through utilizing a four phase
design, which begins with career awareness activities for elementary
and middle school students, this model provides a continuum of
activities that progressively focuses on identifying, retaining, and
advancing interested students to the completion of a baccalaureate
degree. Because of this program, the University of Maryland, Baltimore
has attained a current 70 percent minority medical technology student
enrollment at a majority institution, and an average 89 percent student
retention rate, placing it among the highest in the country. 95 percent
of the graduates of this program receive immediate placement.
Most allied health grant projects continue after federal funding
ends, making them a long-lasting, worthwhile investment in the future
of allied health.
While allied health professionals comprise more than 60 percent of
the entire health care work force, and number more than 3 million
individuals, the attention paid to these health professionals is rather
small. Allied health professionals are involved in the prevention,
identification, monitoring, and evaluation of diseases, disabilities
and disorders. The Allied Health Project Grants program is a relatively
small step in assuring that funding is available to attract allied
health professionals to the professions and to underserved communities,
but, given the critical shortages mentioned, it needs to be taken quite
seriously.
We respectfully request funding for the Allied Health Project
Grants in the amount of $21 million.
The American Society of Clinical Pathologists (ASCP) is a nonprofit
medical specialty society organized for educational and scientific
purposes. Its 75,000 members include board certified pathologists,
other physicians, clinical scientists, and certified technologists and
technicians. These professionals recognize the Society as the principal
source of continuing education in pathology and as the leading
organization for the certification of laboratory personnel. ASCP's
certifying board registers more than 150,000 laboratory professionals
annually.
Thank you for this opportunity to submit written testimony for
inclusion in the hearing record.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM) gratefully acknowledges
Congress' increased support for the Centers for Disease Control and
Prevention (CDC), particularly for the CDC's National Center for
Infectious Diseases (NCID), which supports programs to address emerging
and drug resistant infectious diseases, public health infrastructure,
bioterrorism preparedness and food safety. The CDC is the primary
agency responsible for guarding the public's health, including
protecting the nation against potentially life threatening infectious
diseases. The ASM appreciates Congressional recognition for CDC's role
in responding to the threats of emerging infectious diseases and
encourages Congress to maintain and renew that support.
The ASM endorses the recommendation of the CDC Coalition to
increase the overall CDC budget to $5 billion in fiscal year 2002 to
provide additional new resources for CDC programs focused on national
and global health and security. The CDC is called upon constantly to
identify, control, and prevent outbreaks of disease here and abroad.
For the past fifty years, members of the CDC's Epidemic Intelligence
Service have helped solve microbial mysteries, such as the recent
outbreaks of Legionnaire's disease at a Cleveland automotive plant and
the unexpected arrival in New York of West Nile encephalitis. Despite
this nation's successes against certain diseases, our public health
system continues to be at risk from both new and re-emerging infectious
diseases, from threats of bioterrorism and antibiotic resistant
pathogens, and from an aging public health infrastructure. These areas
are of particular concern to the ASM, which represents more than 42,000
members from a broad spectrum of microbiology-related professions,
including microbiologists who work in biomedical, clinical, public
health, and industrial laboratories.
Prevention strategies promoted by the CDC promise significant
rewards in the form of improved public health. Likewise, strong
financial support for the CDC will give Americans both a healthier
society and cost-saving benefits. The multi-billion-dollar cost of
microbial diseases in this country alarms all of us. Foodborne diseases
alone cost the national health care system more than $3 billion per
year, added to annual lost productivity estimated at $8 billion. On a
global scale, the CDC's participation in eradication campaigns like
that against polio also promises high returns: the United States would
save more than $230 million annually in vaccine costs, and worldwide
the estimated savings would exceed $1.5 billion. Investment in a
stronger CDC undoubtedly will yield measurable positive results in the
form of disease identification and control, helping to fulfill the
CDC's vision of a healthier 21st Century. Investment in CDC will also
enhance national and global security, both economic and political. For
these reasons, the ASM asks Congress to respond aggressively to threats
from infectious diseases with generous support of the Centers for
Disease Control and Prevention.
infectious diseases--threats to national and global health and security
Microbial pathogens and the diseases they cause persist as a
leading cause of death worldwide and in the United States. In today's
global society, it is possible for a new disease to spread
internationally within days, perhaps hours. It is alarming to realize
that infectious diseases would cause even more deaths in this country
if it were not for a persistent federal assault against these
pathogens.
The CDC's vision for the 21st Century is ``healthy people in a
healthy world--through prevention.'' Toward this goal, the CDC launched
a nationwide effort to protect the public from infectious diseases that
includes surveillance and response, applied research, infrastructure
and training, and prevention and control. In 1998 the CDC developed a
comprehensive plan, ``Preventing Infectious Diseases: A Strategy for
the 21st Century,'' listing a sobering array of new and re-emerging
infectious diseases and the obstacles that make stopping these diseases
so difficult. Last year, Congress passed the Public Health Threats and
Emergencies Act to strengthen the public health infrastructure in the
areas of antimicrobial resistance, bioterrorism and major infectious
disease outbreaks.
New and re-emerging infectious diseases pose unique challenges to
the CDC in its role as the nation's prevention agency. More than 35 new
infectious diseases have been identified since 1973, among them those
caused by HIV, E. coli O157:H7, and airborne Ebola virus. The ever-
changing threats posed by infectious diseases demonstrate the
importance of a public health infrastructure capable of rapid and
accurate disease identification and prevention anywhere in the United
States or abroad. On-call CDC personnel consistently assist local and
state health departments across the United States in identifying
outbreaks due to such emergent microorganisms as the West Nile virus.
First described in New York State in 1999, West Nile encephalitis
spread to a wider area during the summer of 2000, carried by mosquitoes
and underscoring the need to rebuild our capability to deal with
vector-borne diseases. The CDC's response illustrates its four-pronged
approach--surveillance and response; applied research; infrastructure
and training; and prevention and control--to protect the public against
infectious diseases. The agency developed a national electronic
surveillance system (ArboNet) to track the virus in humans, birds,
mosquitoes and horses. It also helped develop rapid laboratory tests to
detect the presence of the virus, as well as a DNA vaccine that thus
far looks promising in animal studies. Funding to 49 state and local
health departments and related training sessions and educational
materials enhanced the public health system's chance of stopping the
virus. To prevent spread of the virus, the CDC formulated a large-scale
emergency plan for mosquito control in affected areas.
A similar multifaceted CDC program is in place against hepatitis C
viral infection (HCV), a relatively recent problem in the United
States. HCV is the most common chronic bloodborne viral infection in
the United States, where it has infected more than 4 million people,
nearly 75 percent of whom remain chronically infected. Persistent
infection often leads to serious medical conditions, possibly cirrhosis
or liver cancer; in fact, an estimated 40 to 60 percent of chronic
liver disease is due to this virus. The CDC supports a national survey
of blood collection centers and hospital transfusion services to
determine the progress of notifying transfusion recipients who received
blood from donors who later tested positive for HCV, works with state
and local health departments to coordinate activities including viral
hepatitis education and counseling, testing, referral, surveillance and
vaccination efforts, and coordinates the Hepatitis C Public Information
Campaign. CDC will continue to fund new studies to monitor the
transmission of HCV among various populations, enhance support for
state and local health department programs, and develop and provide
training to healthcare professionals.
New infectious diseases are not the only menace to public health.
Historic killers such as malaria and influenza continue to challenge
national and global health systems. Of all the emerging and re-emerging
infections, influenza has the greatest potential to cause catastrophic
morbidity, mortality, and social disruption both locally and globally.
Three pandemics in the past century were grim reminders of how
dangerous influenza can be. The CDC actively supports influenza
surveillance in other countries, to monitor for variant viruses that
may cause new pandemics. Agency mathematical models suggest that an
influenza pandemic could result in a five-fold increase in U.S. deaths,
compared with non-pandemic years. In a typical year, the disease causes
an average of 20,000 deaths in the United States, along with more than
110,000 hospitalizations. Each year brings new influenza viruses and
fears of even more serious U.S. epidemics, during which up to 40,000
deaths and 200,000 hospitalizations can occur. The CDC counters such
persistent problems with long-term, year-round surveillance both in the
United States and in countries known to be sources of new viruses. As
with other diseases, the agency also works to improve individual
states' ability to respond to epidemics and to strengthen the
international network of laboratories and personnel able to identify
outbreaks. Recognized as a global leader in responding to any disease
outbreak, the CDC must be provided with sufficient resources to improve
its readiness for any future pandemic.
Antibiotic resistance in pathogens and the threat of bioterrorism
have further complicated the current global infectious disease crisis,
forcing health officials to rethink our approach to both old and new
infectious disease. Overuse of antibiotics contributes to a rising
incidence of microbial mutants resistant to the traditional
therapeutic-of-choice. In some areas of the United States, more than 30
percent of pneumococci resist penicillin, a drug once effective against
virtually all pneumococcal pneumonia and meningitis. More than 90
percent of strains of Staphylococcus aureus in U.S. hospitals are
resistant to penicillin; these strains now are spreading into the
general community. Other common infections, such as gonorrhea and
salmonella, also are becoming more difficult to treat. The cost of
resistant diseases is significant: the U.S. health care system spends
an estimated $1.3 billion, annually, on the treatment of nosocomial
infections caused by resistant organisms. It normally costs $2,000 to
treat a patient for tuberculosis in this country, but if the tubercle
strain is resistant, that cost may be inflated 100 times.
On January 18, the Department of Health and Human Services released
its plan to combat antimicrobial resistance, to be led by the CDC, the
Food and Drug Administration (FDA) and the National Institutes of
Health. The plan, which provides a blueprint for coordinated federal
action, has four components--surveillance, prevention and control,
research, and product development. CDC personnel and collaborators will
work with state health departments and others to coordinate and improve
surveillance methodologies. The CDC already has begun preparation of
clinical guidelines for health professionals on the best use of
antimicrobials and on infection control practices, to prevent the
spread of drug resistance. With the FDA and the U.S. Department of
Agriculture, the CDC is monitoring resistant nosocomial infections in
300 hospitals in 15 states. This program complements the CDC's National
Nosocomial Infection Surveillance System (NNISS) already in place, a
prototype system for preventing adverse health care events. An
estimated 44,000 to 98,000 Americans die each year from preventable
medical errors, which include nosocomial infection. In the past decade,
hospitals participating in the NNISS have had a 30 percent decline in
targeted infections.
Substantial funding and flexibility is needed to enable CDC to
fully implement the goals set forth in its strategic and comprehensive
plan against emerging and re-emerging infectious diseases. The ASM
recommends an additional $120 million in fiscal year 2002 to achieve
such goals as improving the detection and prevention of emerging
pathogens, communicating among all levels of government health
agencies, and integrating laboratory science with on-site epidemiology.
BIOTERRORISM PREPAREDNESS AND RESPONSE
Unfortunately, emerging infectious diseases and drug-resistant
pathogens could also be used in terrorist attacks. The CDC considers
bioterrorism as part of its mission against emerging infectious
diseases here and abroad. It is worrisome that there is no guarantee
that the nation's current public health infrastructure could adequately
respond to a bioterrorist event. CDC has joined other federal agencies
in implementing new programs and expanding others to include
counterterrorism capabilities.
To diminish our vulnerability to such attacks, the CDC will
continue to focus its attention on laboratory capabilities at CDC and
at State and local health department levels; on the development and
implementation of rapid diagnostic tests for biological agents; on
surveillance activities with hospitals, health clinics, private and
commercial laboratories, as well as with veterinary and agriculture
partners; on electronic communication capacity at the local level with
the Health Alert Network (HAN) and the National Electronic Data
Surveillance System (NEDSS), designed to collect, analyze and interpret
health-related data in a timely and efficient manner; and on public
health preparedness and readiness activities such as the education and
training of both public and private health care personnel,
firefighters, police officers and emergency medical technicians.
In fiscal year 2002, ASM recommends that Congress provide an
additional $100 million for CDC to continue and expand these activities
to respond to the threat of bioterrorism.
BUILDINGS AND FACILITIES
In protecting American health and safety, the CDC puts science into
action, shares vital information, and creates partnerships with public
and private groups concerned with public health. But unless the CDC's
buildings and physical infrastructure receive more funding from
Congress, its ability to respond to disease anywhere, anytime, could be
seriously undermined. The expansion of CDC's responsibilities around
the world and in the United States has stretched thin the agency's
infrastructure. CDC buildings in Atlanta cannot house the current staff
and about half of that workforce labors in nearly two dozen leased
offices around Atlanta. Much of CDC's laboratory equipment is outdated.
According to the agency, at present 70 percent of its infectious
disease scientists and all of its parasitology and environmental health
specialists work in highly inadequate and potentially hazardous
laboratories. Last year the CDC began a phased 10-year improvement of
its Atlanta facilities. As a result, phase I of the infectious disease
laboratory was completed and opened, and phase II will be completed
this fall. In addition, the emerging infectious disease laboratory is
currently being designed and construction has begun on parasitology and
environmental health laboratories. The ASM appreciates Congress'
attention to CDC's physical infrastructure needs and urges an
additional $175 million in fiscal year 2002, for the construction of
the emerging infectious disease laboratory, the design for the
environmental toxicology laboratory and routine maintenance projects
nationwide.
Thank you for the opportunity to submit ASM's recommendations for
the hearing record of the House Appropriations Subcommittee on Labor,
Health and Human Services, and Education, for the CDC's fiscal year
2002 appropriation.
______
Prepared Statement of the American Society for Microbiology
The American Society for Microbiology (ASM) appreciates the
continued bipartisan support of Congress for the National Institutes of
Health (NIH). Through generous appropriations over the past years,
Congress has brought biomedical research to the forefront of the
national agenda and recognized the NIH's pivotal position in serving
the American public through the support of biomedical research.
Increased support for NIH not only helps to ensure the continued
leadership of the United States in biomedical research, but it will
also allow the United States to address the global health issues in
infectious diseases that currently threaten national security.
The ASM commends President Bush's proposal for a record $2.8
billion increase for the NIH in fiscal year 2002. This proposed
increase is a major step toward meeting the bipartisan goal set by
Congress of doubling the NIH budget by fiscal year 2003, enabling the
Institutes to take greater advantage of the many recent significant
discoveries affecting human health.
Within the past few years we have seen exponential advances in
knowledge in the biomedical sciences. The landmark advances of decoding
the human genome and sequencing over 30 bacterial genomes, discovering
new treatments for AIDS, and developing vaccines that can prevent
meningitis and ear infections in children are only a few of the many
accomplishments that have set the stage for an even more explosive
growth in the benefits derived from NIH research.
The opportunities for substantial return on investment in
biomedical research have never been greater, and it is essential that
the NIH be supported at a level to take full advantage of promising
existing and new areas of basic and clinical research. According to a
report of the Joint Economic Committee, public investment in NIH yields
returns to the economy of 25 percent to 40 percent per year. The
development of the Hemophilus influenzae vaccine to prevent meningitis
in children, for example, has saved an estimated $400 million yearly in
treatment and long-term care costs.
At the same time, we are being challenged by emerging and existing
infectious diseases, increasing resistance to antibiotics, and
accumulating evidence pointing to an infectious cause for many chronic
diseases, such as arthritis, heart disease, and some forms of cancer.
In addition, each year the cost of illness in the United States totals
an estimated $3 trillion in health care and lost productivity,
representing 31 percent of the gross domestic product. The entire NIH
budget equals less than 1 percent of this annual health-related burden
on the national economy.
The ASM, therefore, joins with the Ad Hoc Group for Medical
Research in endorsing an fiscal year 2002 budget increase of $3.4
billion (16.5 percent) for NIH to ensure we reach the goal of doubling
the NIH budget by fiscal year 2003. Such an increase will also enable
the NIH to increase the total number of research project grants it
supports, thereby pursuing a greater number of scientific
opportunities, and to expand training programs, ensuring an adequate
scientific workforce that can translate research discoveries into
significant patient care advances.
PUBLIC HEALTH NEEDS AND INFECTIOUS DISEASES
Past investments in medical research clearly have benefited both
the United States and the world in terms of improved health care and
increased understanding of disease. However, the ASM is concerned about
the continuing onslaught of infectious diseases, a threat directly
confronted by NIH-sponsored research. In the United States, infectious
diseases remain a leading cause of death, with five of the top ten
killers related to infection (pneumonia, AIDS, chronic liver disease,
chronic obstructive lung disease and cancer). The estimated annual cost
of infectious disease in this country exceeds $120 billion. Worldwide,
infections account for more than 13 million deaths each year,
potentially undermining both the political and the economic security of
nations. Seven of the 20 leading causes of global death and disability
are infectious diseases.
We can expect previously unknown infectious diseases--as well as
old diseases with renewed virulence--to continue to imperil public
health. Microbial diseases that appeared just in the last 25 years
include legionnaires' disease, HIV/AIDS, Lyme disease, human cases
linked to mad cow disease, airborne Ebola virus infection, and toxic
shock syndrome. Medical researchers have identified nearly 40 new
disease agents since 1973, some capable of massive destruction. In
1998, HIV/AIDS was the fourth leading cause of death worldwide,
responsible for an estimated 2.3 million deaths that year. In the
United States, pathogens such as hantavirus from rodents, the West Nile
virus, and last year's new hemorrhagic fever virus (the Whitewater
Arroyo virus) appeared during the past decade without warning, claiming
human lives and placing new demands on our health care system. A
recently described hepatitis virus, type C, infects almost 4 million
Americans. Although numbers of new infections have decreased due to
better public health efforts, about 9,000 die from HCV each year and
many more may develop chronic liver disease. HCV is the leading cause
of liver cancer and one of the major reasons for liver transplants.
In recent years there has been a resurgence of several long-time
enemies of public health, historic diseases revitalized by acquired
antibiotic resistance and expedited by global travel and commerce.
Increasingly resistant to traditional therapeutics, malaria continues
to ravage the world's populations, killing an estimated 1.1 million
each year and infecting 275 million new victims. In response to such
alarming statistics, the NIH is leading a multilateral initiative
against malaria, hoping to maximize research against the disease in
Africa. Another long-time threat, tuberculosis kills about 2 million
people each year and persists as the eighth leading cause of death
worldwide, with fully one-third of the global population infected with
the tubercle bacterium. Once treated effectively with drug regimens,
bacteria causing tuberculosis are developing multiple drug resistance.
Not just a problem in developing countries, this more-virulent form of
tuberculosis has now spread to several larger American cities, a
disturbing trend in a health care system where antibiotics have become
the second most commonly prescribed category of drugs.
Other pathogens, such as salmonella, Staphylococcus aureus,
enterococci, and the gonorrhea bacterium, are similarly acquiring drug
resistance, becoming more serious problems in our nation's hospitals.
More than 90 percent of S. aureus found in U.S. hospitals are now
resistant to penicillin and beta-lactam antibiotics, for example. In
intensive care units, nearly one-third of hospital-acquired nosocomial
infections are resistant to the preferred antibiotic treatment.
Nosocomial infections caused by just six of the most common kinds of
resistant bacteria cost the United States at least $1.3 billion
annually. In response, the NIH, CDC and FDA just released the
Antimicrobial Resistance Action Plan, a comprehensive,
multidisciplinary collaboration with private and public groups to
include surveillance, prevention and control, research, and product
development. NIH will lead the research component, towards new
information and technologies and support of clinical studies.
Among newly recognized infectious agents are those now believed
linked to chronic disorders heretofore attributed solely to
environmental or lifestyle factors, thus further complicating our
efforts to improve the public's health. This new concept of infectious
diseases will force a reassessment of chronic disease--one example of
how NIH's focus will change in a new era of medical research. Medical
experts estimate that infectious agents cause 16 to 20 percent of all
cancers, and may be the underlying causes of common chronic diseases
such as diabetes, multiple sclerosis, chronic lung conditions, and
coronary artery disease. Specific infectious agents already have been
indicted in certain conditions: for instance, Helicobacter pylori in
peptic ulcers and Borrelia burgdorferi in some forms of arthritis and
brain disorders. With advances in genomics, it now is possible to
identify non-human genetic material in human diseased tissues, making
this new field of medical research feasible. Investment of research
dollars promises high returns, as suggested by estimates that more than
50 percent of stomach and cervical cancers could be avoided by
preventing their suspected infectious disease etiologies.
Not only must the NIH focus on infectious diseases in this country,
it also must address the cumulative burden of disease worldwide.
Infectious disease agents easily cross national boundaries, creating a
global health interdependence that impacts the health, economics and
foreign policy of the United States. Infectious disease has become a
national security issue, as we become tightly connected to the rest of
the world physically, commercially and culturally. High incidence of
mortality and disability can intensify social and political instability
in countries where the U.S. has significant economic and political
investments. Infectious diseases also raise the possibility of
bioterrorism through deliberate spread of dangerous microorganisms. The
NIH, through its research on diseases that primarily affect other
countries--such as malaria and cholera--accepts a responsibility
towards fighting global infectious disease. The ASM urges Congress to
recognize the NIH's role in national security when determining the
fiscal year 2002 budget.
THE NEED FOR BASIC MICROBIOLOGY RESEARCH AND NIH FUNDING
Scientific knowledge of microbes and their link with larger life
has expanded exponentially in the last half of the 20th century.
Scientists studying microbes discovered that DNA was the genetic
material of life. Many believe that the future of humankind depends on
our ability to understand microbes and how they work and to take
advantage of their abilities to solve some of humanity's most difficult
problems, including the prevention and treatment of infectious
diseases.
The path of scientific investigation will shift in the coming
decades, with new funding needed for a broader scientific base that
will require much more multidisciplinary research. Genomics is just one
aspect of the increasingly complex research enterprise needed to combat
the diseases that afflict humankind. Conquering disease requires
additional emphasis on environment and infectious disease. In
particular the physiologies of organisms, that is the actual
functioning of organisms from microbes to humans, requires
multidisciplinary inputs. Institutes like the National Institute of
Environmental Health Sciences need to do more in areas such as the
environmental reservoirs and transport of pathogens so that we can
understand the epidemiology of many environmentally borne infectious
diseases and act judiciously to prevent them. Studies on the
interactions of genetics, environment, and infectious diseases is
critical for preventing and treating many human diseases.
Immediate attention is needed to reverse the decline in the field
of microbial physiology or we risk losing ground in medical and
environmental research and discovery. The once flourishing field of
basic (prokaryotic) microbiology is no longer receiving sufficient
attention. The decline in funding devoted by the NIH to bacterial
physiology is compounded by the limited budgetary growth of other
agencies, such as the National Science Foundation, to support the basic
cellular biological studies of prokaryotes. Given that an understanding
of bacterial physiology is a critical underpinning to overall cellular
studies that are key to the advancement of the broader life and
biomedical sciences, the NIH would be well served by coordinating with
other agencies to ensure the adequacy of funding for bacterial
physiology. This would be an important step for overcoming the shortage
of qualified scientists with training in bacterial physiology to fill
the employment opportunities available in biotechnology and biomedical
research laboratories The ASM recommends that NIH recommit itself to
rebuilding support for this critical area and to take steps such as
training grants and requests for proposals to increase the number of
laboratories, institutions, and scientists working in this area.
The ASM emphasizes the importance of providing increased support
for the basic, untargeted research in the biomedical sciences supported
by the National Institutes of General Medical Sciences (NIGMS), which
provides the fundamental underpinning for all the disease-oriented
research done by other NIH Institutes. If we are to sustain the
momentum of NIH research in the future--and to build upon the notable
advances made in recent years--it is important to recognize that basic
and clinical research both are indivisible segments of successful
medical science. Basic science is at the heart of what the NIH and
research institutions do best. Basic research is the engine that drives
scientific creativity and productivity making sustained funding for new
research projects a particularly critical issue when deciding the
fiscal year 2002 budget. There must be a high-quality continuum of not
only new projects, but new scientist training programs, to keep
American medical science of the future as vigorous as it is today. We
also need more physician-investigators trained to translate discoveries
into patient care and lives saved.
REQUIREMENTS FOR TODAY'S RESEARCH
Technological innovation may become the most visible hallmark of
research in the 21st century, but it is just one aspect of an
increasingly complex and expensive system needed to combat infectious
diseases and other threats to national and global health. It is
essential that financial support of the NIH includes sufficient funds
for all facets of the research process, whether state-of-the-art DNA
sequencing equipment or increased stipends for scientists-in-training.
New pathways to medical discoveries rely upon a complicated,
interlocking framework of scientific infrastructure, which needs to be
updated with an infusion of federal funding. Skilled personnel and
premier research facilities are the foundation of U.S. research and
make medical advances happen. The more the research landscape changes,
the more researchers must have expertise outside the traditional
boundaries of their disciplines, and research facilities must make this
cross-pollination possible. The fields of bioinformatics, imaging, and
computer science will repeatedly meld with biology and chemistry. These
scientific cross-currents will require new and creative training
programs to produce interdisciplinary scientists, as well as greater
financial incentives to retain the best of these at federal research
centers.
RESEARCH STEWARDSHIP FUNDING
The management and support budget of the NIH is decreasing as a
percentage of the agency's entire budget, a trend that negatively
affects the best administration of federal research dollars. This
deficiency undermines the strength of the NIH and its promise to the
American public to improve health and well-being.
ECONOMIC BENEFITS
Medical advances in the past have directly minimized the cost of
specific diseases. The United States spent a total of $32 million over
10 years to support the global smallpox campaign. Economists estimate
that, every 2\1/2\ months since the world was declared smallpox-free in
1977, the entire $32 million has been recouped in health cost savings.
The ongoing anti-polio campaign promises similar results: The United
States will save more than $230 million annually in vaccine costs,
while globally, the annual savings is expected to exceed $1.5 billion.
At the NIH's National Institute of Allergy and Infectious Diseases,
research costing $31.8 million produced the hepatitis B vaccine, saving
our health care system an estimated $73.7 million to $146.6 million
each year. But the price of illness in this country will grow if we are
not prepared to confront all new and costly diseases, such as
antibiotic-resistant infections and the inevitable yet-unknown
pathogens. The NIH, and specifically, the National Institute of Allergy
and Infectious Diseases (NIAID), is at the center of a national mission
to stop these diseases, a mission that must be adequately funded in the
fiscal year 2002 budget.
The American Society for Microbiology, the largest single life
science society with over 42,000 scientists, appreciates the
opportunity to provide these recommendations to the Senate Subcommittee
on Labor, Health and Human Services and Education Appropriations and
stands ready to assist the Subcommittee in any way possible.
______
Prepared Statement of the American Society of Tropical Medicine and
Hygiene
The American Society of Tropical Medicine and Hygiene (ASTMH)
appreciates the opportunity to submit testimony to present our views on
fiscal year 2002 funding priorities to the Subcommittee.
The ASTMH is a professional society of 3,500 researchers and
practitioners dedicated to the prevention and treatment of infectious
and tropical diseases. The collective expertise of our members is in
the areas of basic science, medicine, vector control, epidemiology, and
public health.
The staggering burden of tropical and infectious diseases confronts
us on a daily basis. Poor health and the spread of infectious disease
across borders have profound effects 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 affect
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.
Now more than ever, we must be vigilant in our efforts to control
and eradicate infectious diseases. In this new millennium, 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 diseases and antimicrobial resistance. Tuberculosis
(TB) and malaria are renewed threats because they are becoming
increasingly drug resistant. Monitoring, preventing, and controlling
antimicrobial resistance requires sustained effort, commitment, and
collaboration among public and private sectors, with support and
leadership from the Federal Government.
NATIONAL INSTITUTES OF HEALTH (NIH)
The Society thanks 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. Investments
in NIH have led to an explosion of knowledge that promises to advance
our understanding of the biological basis of disease and unlock new
strategies for disease prevention, diagnosis, treatment, and cures.
Congress responded to these opportunities by pursuing, in a bipartisan
fashion, an effort to double the NIH budget over the five-year period
of fiscal year 1999 to fiscal year 2003--and we are now over halfway to
that goal. The ASTMH joins the Ad Hoc Group for Biomedical Research
Funding in urging you to maintain support for the Congressional
campaign to double the NIH budget. We seek your support for an
appropriation of $23.7 billion for NIH in fiscal year 2002. This $3.4
billion (16.5 percent) increase represents the fourth step toward the
bipartisan goal of doubling the NIH by fiscal year 2003, and will allow
promising research avenues to be pursued, including the development of
new vaccines and drug therapies for diseases such as malaria, TB,
dengue fever, cholera and other diarrheal diseases, HIV/AIDS, and a
myriad of other viral bacterial, fungal, and parasitic disease agents.
As a result of the increased funding of the NIH, new scientific and
research opportunities are being pursued that hold the potential to
prevent and control tropical and infectious diseases around the world.
Infectious diseases are the second leading cause of death worldwide,
accounting for over 13 million deaths (25 percent of all deaths
worldwide in 1999). Twenty well-known diseases--including TB, malaria,
and cholera--have reemerged or spread geographically since 1973, often
in more virulent and drug-resistant forms. At least 30 previously
unknown disease agents have been identified in this period--including
HIV, Ebola, and hepatitis C--for which no cures are available.
Additional support for clinical research is needed to take
advantage of existing opportunities and develop new approaches to
accelerate efforts to develop vaccines and drug therapies for HIV/AIDS,
malaria, TB, and hepatitis C. Emerging scientific opportunities and
recent developments in infectious disease research include sequencing
the human genome and recombinant DNA technologies for developing new
vaccines, such as the very successful vaccines against hepatitis B that
are now given to all children in the United States. Although it will be
a great challenge, we are optimistic that similar such vaccines can be
developed against the big three global killers: AIDS, TB, and malaria.
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
The National Institute of Allergy and Infectious Diseases (NIAID)
is the third largest institute at the NIH, with a fiscal year 2001
budget of more than $2 billion, a 15 percent increase from fiscal year
2000. During the past 15 years three factors have prompted NIAID to
grow significantly: the emergence of HIV/AIDS in the early 1980s;
results from basic research that are now driving new approaches to
solving clinical and public health problems; and the realization that
infectious diseases will continue to emerge unpredictably and at times
explosively. There are several important on-going issues relating to
NIAID's research efforts in tropical and infectious diseases that we
would like to highlight.
Acquired Immunodeficiency Syndrome (AIDS).--In the United States,
an estimated 271,000 people are living with HIV, and the rate of the
new HIV infections, approximately 40,000 per year, continues at an
unacceptably high level. NIAID-supported basic research identified the
HIV protease enzyme as a target for antiviral drugs, which led to the
development of very potent protease inhibitors, that have prolonged and
improved the quality of life for many HIV-infected people. However,
effective, low-cost tools for HIV prevention, such as a vaccine and
affordable drug therapies, are needed urgently to bring the HIV
epidemic under control.
Tuberculosis (TB).--TB is the eighth leading cause of death
worldwide. One-third of the world's population has latent TB,
constituting a huge reservoir from which active TB can surface.
Moreover, multidrug-resistant TB is an increasing problem.
Malaria.--Malaria has been undergoing a global resurgence in recent
years, partially related to drug resistance, with 275 million cases
occurring annually, and a death toll estimated at 1 to 2 million,
primarily children.
Hepatitis.--Hepatitis (liver inflammation) can be caused by several
viruses. The most common are hepatitis A, a food- and water-borne
infection that is a particular risk for travelers, and hepatitis B and
hepatitis C, both of which are blood-borne. We now have excellent
vaccines for hepatitis A and B, but none for hepatitis C, which kills
about 9,000 Americans annually.
Emerging Infections.--There are numerous emerging infectious agents
among the viruses, bacteria, protozoa, and fungi that make up the
microbial world. Because the frequency of world travel makes the United
States part of a global community, diseases that emerge in foreign
countries are also health threats in the United States.
The Society commends the NIH and NIAID for their continued
leadership and focus on tropical and infectious diseases. We urge the
Subcommittee to strongly support efforts of the NIAID to develop new
and improved methods for treating illness, controlling outbreaks, and
preventing epidemics that continue to challenge global health.
Tropical Medicine Research Centers.--The NIH's tropical disease
research program is funded primarily by the NIAID. This year marks the
tenth anniversary of the International Centers for Tropical Disease
Research network, established by NIAID to build new and strengthen
established partnerships between U.S. scientists and investigators from
tropical disease endemic areas; NIAID and other government agencies
with interests in tropical disease research; and academic scientists
and private industry, to encourage translational and collaborative
research. The Society strongly urges that the Committee express its
continued support for these unique research opportunities.
FOGARTY INTERNATIONAL CENTER (FIC)
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, and their efforts to train scientists in molecular
biology and molecular epidemiology techniques of relevance to
developing countries in which research collaborations will be
conducted. The new training program in clinical investigation is a
necessary component of new NIH initiatives such as the HIV Prevention
and Vaccine Trials Networks and other expanding human research programs
in the developing world. The Society supports training local
investigators as an investment in the research itself.
TRAINING/CAREER DEVELOPMENTS
It is clear to those of us who have devoted our careers to fighting
tropical and infectious diseases that we need to attract the best and
brightest young students and trainees to our field if we are to take
full advantage of advances in science and technology and to make
progress in the global war against infectious diseases. NIAID and the
Fogarty International Center have taken the lead with initiatives for
training students and young scientists and clinicians in tropical
medicine and international health. However, compared to the need, there
remains a shortage of training opportunities and especially support for
junior researchers at the point in their training when they must choose
between more mainstream careers in clinical medicine or other areas or
research, or the sometimes more challenging path of tropical medicine
and infectious disease research. We urge you to consider additional
support for training and career development programs, which we feel are
most successful when they are integrated with research funding.
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 continued support 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. We also
urge you to continue to fund the CDC's efforts to control global
malaria.
CONCLUSION
In the 21st Century we must aggressively pursue the battle against
tropical and infectious diseases, which 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. We stand at the threshold of an exciting new era of medical
progress, exemplified by the recent completion of the sequencing of the
human genome. Opportunities for new treatments, diagnostics, cures, and
preventive measures have never been greater. We must also be prepared
to confront the new challenges that will lie ahead. The path of
progress will be different in the coming era, as the demand increases
for a broader science base, more interdisciplinary research, and
improved technology.
REQUEST
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 support an
appropriation of $23.7 billion for the NIH in fiscal year 2002, with a
corresponding increase for NIAID. We also request that the Committee
support increased funding 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 Association for Professionals in Infection
Control and Epidemiology, Inc.
Good morning. My name is Julie Rish McCord. I am an infection
control nurse for North Mississippi Medical Center, in Tupelo,
Mississippi. I am here today representing the Association for
Professionals in Infection Control and Epidemiology (APIC). APIC is a
non-profit organization representing nearly 12,000 infection control
professionals who work across the continuum of health care.
APIC has long been a strong proponent of science-based programs
designed to protect patients and health care workers, such as those of
the Centers for Disease Control and Prevention (CDC). We are extremely
concerned, however, about regulations that are not based upon sound
science and are unnecessary and costly to implement. Specifically, I am
referring to the proposed OSHA rule to prevent occupational exposure to
tuberculosis (TB).
OSHA's proposed requirements would place additional burdens on
health care providers while failing to add protection for health care
workers. We are in dire need of Congressional assistance in opposing
this proposed rule. We greatly appreciate the efforts of Congressman
Roger Wicker, who, at our request, sponsored language in the fiscal
year 2000 appropriations bill calling for an independent study of the
proposed rule by the Institute of Medicine (IOM). This study culminated
in the publication of the report, ``Tuberculosis in the Workplace,''
issued by the IOM on January 16, 2001. We would like to highlight seven
of the report's major findings.
One: health care workers as a group are not at increased risk;
Two: the primary risk to health care, correctional, and other
workers now comes from patients, inmates or clients with unsuspected,
undiagnosed infectious TB. There is no regulatory standard that could
ever address this risk, since TB is not even suspected in these
patients;
Three: CDC guidelines for the prevention of occupational exposure
to TB have been implemented, as appropriate, and are working;
Four: OSHA overstated the risks to health care workers by using
out-dated information and data from outbreaks to craft a proposed rule
that is unnecessary and would be ineffective and costly;
Five: OSHA vastly overestimated the benefit that could be derived
from implementation of its proposed rule;
Six: A respiratory protection program should be tailored to the
level of risk within a facility; and
Seven: the proposed rule will not allow the necessary flexibility
for organizations to adopt the TB control measures that are most
appropriate to the level of risk facing their individual workers.
The report states, ``. . . if an OSHA standard follows the 1997
proposed rule it may not offer sufficient flexibility for organizations
to adopt control measures appropriate for the level of risk facing
workers. To the extent that an OSHA standard inflexibly extends
requirements to institutions that are at negligible risk of
occupational transmission of M. tuberculosis, the standard is unlikely
to benefit workers at the same time that it would impose significant
costs and administrative burdens on covered organizations and absorb
institutional resources that could be applied to other, potentially
more beneficial uses.''
With this information, Congress should take further and stronger
action to ensure that this rule, which will be virtually ineffective
and overly burdensome to facilities, is not issued.
I bring this message to you on behalf of my professional
organization, but I am also speaking to you today as someone who has
had direct experience with TB disease. My mother was diagnosed with TB
in the 1950s. In the years that followed, my family and I stood by her
side as she experienced many complications as a direct result of TB,
which contributed to her death in 1995. I can tell you from first-hand
experience that TB is a truly devastating disease. APIC cares very much
about protecting health care workers (including ourselves) from TB.
While the intention behind this rule may be sincere, it does not
address the area of true risk.
There is no doubt that in the late 1980s, the public health
infrastructure and health care facilities were not prepared for the
devastating combination of HIV/AIDS and TB, but the incidence of TB in
the U.S. is now at its lowest level ever recorded. TB is a public
health issue, not a facility-specific issue. Health care workers are
already protected from patients with known or suspected TB. In fact,
the rate of TB in health care workers is lower than the rate among the
general population.
TB is a public health issue because it is in our communities and
largely undetected. People with active TB disease, who go undetected,
pose a risk to others until they are identified, isolated and treated.
Strengthening our public health programs will allow us to target
prevention and treatment programs to high-risk populations--
particularly immigrants--provide directly observed therapy, and
thoroughly investigate all cases for spread to contacts.
With regard to this regulation, I would like to make one final
point, as someone who has lost a family member to the complications of
TB. If I believed for one moment that this rule would prevent people
from contracting this terrible disease, I assure you, I would not be
testifying before you today. The OSHA TB rule will offer no added
protection for workers and will be logistically and financially
burdensome for facilities nationwide. We would appreciate your
assistance in halting the issuance of a final rule.
Infection control professionals nationwide wish to thank this
subcommittee for its long-standing support of the Centers for Disease
Control and Prevention (CDC), particularly with regard to funding for
infectious disease programs. Through its efforts and expertise, the CDC
has been instrumental in national as well as international efforts to
control the incidence and spread of infectious disease. Since the CDC
is the primary entity responsible for safeguarding the public's health,
it is imperative that it be granted adequate resources to perform this
monumental task. APIC recommends an fiscal year 2002 funding level of
$5 billion and we hope that the subcommittee will take this into
consideration during the appropriations process.
APIC believes that the CDC needs more resources in order to
adequately address infection prevention and control at both the
national and international levels. Infectious disease is the leading
cause of death worldwide and a significant cause of death here in the
United States. APIC members, many of whom work on the front lines in
infection control and in public health capacities, recognize the urgent
need for enhanced prevention measures as well as increased
surveillance.
In recent decades, significant progress has been made in the
prevention and control of many infectious diseases. Today, our efforts
are confounded, despite our many accomplishments. Changes in human
behavior, alterations to the environment, deterioration of our public
health infrastructure, widespread antibiotic usage, and dramatic
increases in international commerce and travel are factors contributing
to the proliferation of drug resistance and new and resurgent
microorganisms.
For this reason, APIC also strongly supports full funding of Public
Law 106-505, the Public Health Improvement Act, which includes
authorization language to address public health emergencies such as
antimicrobial resistance and bioterrorism. We are requesting:
--$4 million through fiscal year 2006, to enhance surveillance
networks throughout our public health system;
--$95 million through 2006 to establish competitive grants to address
core public health capacity needs to best identify, monitor,
and respond to public health threats;
--$180 million for fiscal year 2002, through 2010, for new facilities
construction and renovating existing facilities at the CDC; and
--$40 million through fiscal year 2006, to establish an Antimicrobial
Resistance Task Force, and to establish competitive grants and
demonstration programs to conduct research and development for
new antimicrobial drugs and diagnostics.
Federal funding would enhance surveillance sites, strengthen
epidemiological and laboratory response capabilities and support
efforts to address emerging infectious disease on a global level. We
are hopeful that the committee will recognize the absolute necessity of
this program and provide the highest possible level of funding.
Thank you for your attention to these concerns.
______
Prepared Statement of the Association of Minority Health Professions
Schools
Mr. Chairman, thank you for the opportunity to present the views of
the Association of Minority Health Professions Schools (AMHPS). I am
Ronny B. Lancaster, Senior Vice President for Management and Policy at
Morehouse School of Medicine, and President of AMHPS.
AMHPS is an organization which represents twelve (12) historically
black health professions schools in the country. Combined, our
institutions have graduated 50 percent of African-American physicians
and dentists, 60 percent of all the nation's African-American
pharmacists, and 75 percent of the African-American veterinarians.
Mr. Chairman, historically black health professions institutions
are addressing a pressing national need in carrying out their mission
of training minorities in the health professions. While African-
Americans represent approximately 15 percent of the U.S. population,
only 2-3 percent of the nation's health professions workforce is
African-American. Studies have demonstrated that when African Americans
and other minorities are trained in minority institutions, they are
much more likely to: (1) serve in medically underserved areas, (2) care
for minorities, and (3) accept patients who are Medicaid dependent or
otherwise poor. This is important Mr. Chairman because the gap in
health status between our nation's minority and majority populations
continues to widen due in part to the lack of access to quality health
care services in minority communities. As a result, we believe it is
imperative that the federal commitment to training African Americans
and other minorities in the health professions remains strong.
In spite of our proven success in training health professionals,
and the important contribution these professionals make, our
institutions continue to face a financial struggle inherent to our
mission. The financial challenges facing the majority of our students
affect our institutions in numerous ways. For example, we are unable to
depend on tuition as a means by which to respond to any discontinuation
of federal support. Moreover, the patient populations served by the
AMHPS institutions are overwhelmingly poor. As a result, our
institutions cannot rely on patient care income at a time when the
average medical school gets 40-60 percent of its operating revenue from
health care services.
Mr. Chairman, due to the many challenges facing our institutions,
AMHPS was very pleased that the Department of Heath and Human Services
made reducing the health status gap between our nation's minority and
majority populations a top priority in fiscal year 2001. We look
forward to continuing to work with all agencies of the Public Health
Service in fiscal year 2002 to make additional progress toward the goal
of eliminating all health status disparities by 2010.
Mr. Chairman, before I present AMHPS's appropriations
recommendations for fiscal year 2002, I would like to state for the
record that these programs represent, quite frankly, the difference
between keeping the doors open or closed at many of our nation's
minority health professions institutions.
FISCAL YEAR 2002 RECOMMENDATIONS FOR FEDERAL PROGRAMS OF INTEREST TO
AMHPS
National Institutes of Health
Mr. Chairman, I would like to take this opportunity to thank you
for your support of the establishment of the National Center for
Minority Health and Health Disparities at NIH last year. As you know,
ethnic minorities and medically underserved populations suffer
disproportionately from virtually every major form of disease. Despite
this longstanding public health problem, the former Office of Research
on Minority Health at NIH had neither the authority nor the resources
to adequately address the challenges in this country with respect to
health status disparities.
The new National Center and its leadership now have the authority
to:
--Directly support biomedical research, training, and information
dissemination focused on eliminating health status disparities.
--Serve in a leadership capacity in developing a comprehensive plan
for minority health research at NIH.
--Participate as an equal when NIH institute and center directors
meet to determine research policy.
--Establish and support research programs at health professions
institutions that are studying diseases which
disproportionately impact ethnic minority and medically
underserved populations.
On behalf of the minority health community, I would like to commend
the subcommittee for appropriating $130 million for the National Center
in fiscal year 2001. Given the immense public health challenge of
eliminating health status disparities in this country by 2010, AMHPS is
recommending that the National Center receive an appropriation of $200
million in fiscal year 2002. In addition, AMHPS strongly supports the
goal of doubling the NIH budget by fiscal year 2003 and joins with the
Ad Hoc Group for Medical Research Funding in recommending a 16.5
percent increase ($3.4 billion) for NIH in fiscal year 2002.
Research Centers at Minority Institutions
The Research Centers at Minority Institutions program (RCMI) at the
National Center for Research Resources has a long and distinguished
record of helping our institutions develop the research infrastructure
necessary to be leaders in the area of health disparities research.
Although NIH has received unprecedented budget increases in recent
years, funding for the RCMI program has not increased by the same rate.
Therefore, AMHPS recommends that funding for this important program
grow at the same rate as NIH overall in fiscal year 2002.
Animal Research Facilities Improvements
Minority health professions institutions have identified a pressing
need to upgrade our animal research facilities in order to remain
competitive in the field of biomedical research. We are grateful for
the subcommittee's support last year of our ``animal facilities
improvement initiative'' and are pleased to report that a majority of
our institutions are working with NCRR to upgrade their animal care
infrastructure.
To continue this important initiative we urge the subcommittee to
provide an adequate level of funding within the Developing and
Improving Institutional Animal Resources program at NCRR to assist the
remaining schools in improving their animal facilities.
Extramural Facilities Construction
The minority health professions community thanks the subcommittee
for its support of NCRR's Extramural Facility Construction program over
the past two years. It is critical that our nation's research
infrastructure remain strong if we are to take full advantage of the
historic increases in biomedical research funding that the Congress has
provided to NIH.
Under legislation passed last year, the authorization level for the
Extramural Facility Construction program was increased from $150
million to $250 million. Moreover, the new law maintains the 25 percent
set-aside for Institutions of Emerging Excellence (many of which are
minority institutions) for funding up to $50 million and allows the
NCRR director to waive the matching requirement.
Current funding for the Extramural Facility Construction program at
NCRR is $75 million. AMHPS encourages the subcommittee to continue its
strong support for this program in fiscal year 2002 by increasing its
appropriation by the same percentage as NIH overall.
Research Infrastructure Development
Mr. Chairman, as we review the priorities of our member
institutions with respect to NIH, clearly most of our needs relate to
institutional infrastructure, and those programs which help our schools
enhance their capabilities to compete for research funding on a level
playing field. Now that these programs are in place, we believe there
should be an effort to coordinate these infrastructure development
programs so our schools can work with NIH to approach them on a
comprehensive, rather than on a piece-meal basis. It would seem more
efficient for NIH to work with our schools to collaborate on our
infrastructure needs, and coordinate efforts to help us build our
infrastructure.
Strengthening Historically Black Graduate Institutions--Department of
Education
The Department of Education's Strengthening Historically Black
Graduate Institutions program (Title III, Part B, Section 326) is
extremely important to AMHPS institutions. The funding from this
program is used to enhance educational capabilities, establish and
strengthen program development offices, initiate endowment campaigns,
and support numerous other institutional development activities.
Mr. Chairman, we applaud the subcommittee's leadership in securing
a funding level of $45 million (an increase of $14 million) in fiscal
year 2001 for this vital program. For fiscal year 2002, AMHPS
recommends an appropriation of $60 million to continue the vital
support that this program provides to historically black graduate
institutions.
Health Professions Training for Diversity at the Health Resources and
Services Administration
The health professions programs supported by this subcommittee are
the only federal initiatives designed to address the longstanding
under-representation of minority individuals in health careers. HRSA's
Minority Centers of Excellence, Health Careers Opportunity Program, and
Scholarships for Disadvantaged Students, support those institutions
with a historic mission and commitment to increasing the number of
minorities in the health professions.
Mr. Chairman, our schools and students greatly appreciate the
consistent support of this subcommittee for these important programs
and recommend the following funding levels for fiscal year 2002:
--$40 million for Centers of Excellence (an increase of $9.4 million
over fiscal year 2001).
--$40 million for the Health Careers and Opportunities Program (an
increase of $7.2 million over fiscal year 2001).
--$50 million for the Scholarships for Disadvantaged Students program
(an increase of $5.5 million over fiscal year 2001).
Finally, we are working with HRSA and Bureau of Health Professions
leaders to ensure that the COE and HCOP programs continue to focus on
providing support to minority serving institutions. Recently proposed
changes to the eligibility criteria for COE, and the process for
awarding HCOP grants, have raised some concerns in the HBCU community.
We look forward to working with the subcommittee to ensure that these
programs continue to benefit those institutions with the greatest need.
HHS Office of Minority Health
The HHS Office of Minority Health (OMH) plays a critical role in
ensuring that all Public Health Service agencies focus appropriate
resources on improving the health of our nation's minority citizens.
Although their task is daunting, progress has been made thanks to the
leadership of OMH.
OMH has helped our institutions directly by supporting a
comprehensive study on how our schools can better compete as health
care providers and educational entities in the age of managed care.
Moreover, we are working to develop a partnership with OMH in support
of AMHPS's Annual Symposium on Careers in the Biomedical Sciences. This
unique event brings together over 1,000 minority and other high school
and college students each year to expose them to career and educational
opportunities in the health sciences. Many believe that this is the
best program of its type in the country.
To continue the important mission of the Office of Minority Health,
we are recommending a funding level of $60 million in fiscal year 2002
(an increase of $11 million over fiscal year 2001).
Centers for Disease Control and Prevention
Minority populations of many ethnic backgrounds are at an increased
risk of suffering from low birth weight, infectious disease, sexually
transmitted diseases, tuberculosis, and other chronic disorders.
The Centers for Disease Control and Prevention has taken a
leadership role in combating these problems through its various health
status disparities initiatives. Because of the proximity of minority
health professions institutions to disadvantaged, medically underserved
communities, our institutions frequently partner with CDC in support of
community based, prevention and control initiatives. We encourage the
subcommittee to provide CDC with an overall appropriation of $5 billion
in fiscal year 2002 (an increase of $1.1 billion over fiscal year
2001).
Mr. Chairman, once again, thank you and this subcommittee for your
longstanding support of these very important programs. I appreciate the
opportunity to present the views of the Association of Minority Health
Professions Schools.
______
Prepared Statement of Babyland Family Services, Inc.
Mr. Chairman: On behalf of Babyland Family Services, Inc. I
appreciate the opportunity to submit this written testimony to you on
three important initiatives: (1) a Pediatric Health Center; (2) an
Education Technology project; and (3) a Family Violence and Child Abuse
Initiative.
Babyland provides child care and early childhood education services
for 750 children (0 to five years old) at eight child care centers and
provides emergency shelter and family support services to 750 other at-
risk and low-income children and families. Babyland is currently
Newark's Early Head Start grantee (serving children 0 to 3 years old,
pregnant teenagers, young fathers and families living with HIV/AIDS)
and has a partnership with the Newark Public Schools to provide Abbott
preschool services to over 250 children. The agency has an extensive
partnership with the New Jersey Department of Human Services for the
provision of child welfare, family violence and child care services.
Babyland is a leader in Newark for the promotion of accredited child
care centers and has been recognized by The Annie E. Casey Foundation
as a model child and family development organization through its 2001
Families Count Honors Program.
Babyland is a lead agency for the United Way's Success By 6
Initiative and the State's Family and Children Early Education Services
(FACES) Initiative which, combined, provides early childhood support
services to 2,000 children and over 20 other child care agencies and
schools. Finally, Babyland and Passaic Beth Israel Hospital have
partnered to implement the Pediatric Asthma Reduction Effort (PARE),
which is funded by the Robert Wood Johnson Foundation to develop a
model pediatric asthma education and management program for children in
Newark and Passaic.
THE BABYLAND PEDIATRIC HEALTH CENTER: WHERE HEALTHY BEGINNINGS LEAD TO
BRIGHTER FUTURES
Babyland is seeking $1 million for the rehabilitation or
construction of a Pediatric Health Center. Babyland is in a unique
position, as the lead agency for several collaborative initiatives that
promote the development of young children under six years old, to
launch a pediatric health initiative that will prevent and manage
childhood illnesses in Newark. As part of the agency's new multipurpose
building, this federal funding will enable the agency to include a
pediatric and family health center that will directly provide basic
health services to over 1,000 families and provide health education,
assessments, screening and follow-up services to 2,000 families with
children under six years old. In addition to the pediatric and family
health center, the new multipurpose building will include a child care
center for 137 children (0 to 5 years old), a computer technology
center, an employment training and placement center and family resource
center. The new health center will particularly focus on increasing
immunizations, screening for lead poisoning, asthma management,
preventive dental care services, nutrition, prenatal care, home safety,
parent education and child development, HIV/AIDS prevention and other
preventive health education.
In partnership with over 20 child care agencies, elementary schools
and local health care providers, Babyland will develop a coordinated
community-based approach for residents to gain access to health care
services. Increased access to health care services will be achieved
through the following methods: training for over 50 Abbott Family
Workers who provide case management services for 2,000 preschoolers;
parent-to-parent workshops that will be part of a series of parent and
health education workshops; and creative grass-roots efforts that will
encourage families to utilize the health center's resources. Community
outreach workers, parents, nurses and a team of other health
professionals will provide health outreach, education and services.
Services will be coordinated with the Newark Department of Health, the
Newark Public Schools and other local health care service providers.
Matching Funds.--$1 million capital funding from the following: The
Annie E. Casey Foundation ($500,000 unrestricted award) and $500,000
from a lender. Operating funds will come from the United Way and the
State of New Jersey. Other potential funders could include previous
health-related supporters such as the Robert Wood Johnson Foundation
and the Healthcare Foundation of New Jersey.
THE NEWARK PROJECT: A SOLUTION TO THE DIGITAL DIVIDE AMONG URBAN
FAMILIES
The purpose of this initiative is to serve as a model educational
program that closes the digital divide among minority inner city
children and families. This technological network links center and
home-based child care centers and schools; 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 focus of this initiative is to establish the telecommunications
linkages necessary for the educational development of 1,000 preschool
and school-age children and to provide computer and technology training
for 2,000 parents, teachers, family service workers and entry-level
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.
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.
This technology initiative will assist clients who have no other
tangible means of becoming computer literate and of acquiring the
requisite skills necessary to be informed and self-sufficient.
Specific Provisions
--Technology Center, as part of a new multi-purpose community
resource and education center, that will provide distance
learning, online and network linkages to educational
institutions and community resources, professional development
and training in basic and advanced computer and technology
skills for low-income parents, neighborhood residents and
entry-level employees.
--Technology hardware and software (technical assistance, network
installation and expansion, wiring, modems, printers etc.) for
children, parents and residents, and teaching/social service
staff in classrooms, homes, family resource centers and safe
havens.
--Technology Training, Curriculum Development and Professional
Development for children, parents and residents, educational
and social services staff, as well as local, State, national
and international community-based family service providers.
The initiative will benefit the following
--Children at nine child care centers (850 preschoolers) and 400
school-age children (charter school and after school/summer
enrichment programs) at six centers and schools.
--Parents and family members (2,000) at 14 Babyland sites with links
to community resources;
--Agency Staff (300), including teachers and family service workers,
for client tracking purposes; training and professional
development; and access to community resources to be provided
through workstations, wireless technology and/or palm pilots.
--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 Newark, New Jersey,
the nation and South Africa, who will receive training in
child, family and community development.
Key Outcomes
--Enhanced early childhood development and education for children
(three to 13 years old).
--Enhanced ability of inner city residents, especially low-income
parents and teenagers, to learn computer and technology skills.
--Enhanced tracking of 1,500 children in center- and home-based child
care facilities; teenage parents; victims of domestic violence;
homeless families; and children in foster care.
--Enhanced delivery of professional development of teaching and
family service staff.
--Enhance the provision and delivery of parent education programs.
--Enhanced delivery of clinical and therapeutic services to parents
and children.
--Enhanced ability to fulfill State and Federal reporting
requirements and to provide community development consultation
to local, State, national and international family service
providers.
This project received an allocation of $723,000 in the last fiscal
year. But in order for the system to be fully operational and
implemented for the entire target clientele population, an additional
allocation of $2 million is being sought.
MEN FOR PEACE
Babyland is seeking $500,000 under the Administration on Children
and Families Community Services Block Grant to integrate its family
violence and child abuse prevention and crisis intervention services in
order to develop a comprehensive program for 500 children and families.
Key components of the initiative will include: Intensive family
reunification and permanency planning for children in foster care;
counseling for male batterers; parent education; mental health
counseling; substance abuse counseling; and specialized services for
at-risk men.
Babyland currently provides prevention and crisis intervention
services for 500 abused and neglected children (under five years old)
and 200 battered women. The agency provides foster care services for
nearly 300 children (siblings and infants, or boarder babies). Babyland
is also a lead agency for the Responsible Fatherhood Initiative, which
utilizes a collaboration of several support service agencies to mentor
young men who have substance abuse problems.
This project will enable the agency to integrate and build
components of its prevention and intervention services that emphasize
the utilization of men--fathers and male role models--toward the
reduction of child abuse and domestic violence. This initiative will
draw upon the strengths of specially trained male role models in
providing mentorship and parent education for young fathers, counseling
for batterers and men at risk of abuse or violence as well as outreach
to fathers with children in foster care. The project will employ
innovative methods to engage and educate young men and fathers as well
as comprehensive support services that will promote self-sufficiency
and family development.
Matching Funds--$500,000 from the United Way of Essex and West
Hudson and the NJ State Department of Human Services
Thank you for your consideration.
______
Prepared Statement of Canavan Research Illinois
Dear Mr. Chairman: Thank you for hearing my testimony explaining
why orphan diseases, and Canavan disease in particular, are in
desperate need of Government funding for medical research.
Because neurodegenerative diseases are all related, there will be
gains in medical science that reach far beyond these rare diseases.
Research for Canavan disease will have a spill over effect, and
ultimately help millions of Americans.
I can personally attest to the impact that Canavan disease has on
the family it affects. Canavan disease develops in early childhood and
is 100 percent fatal. Canavan disease (CD) is progressive; our children
lose motor skills until eventually they can no longer even breath or
swallow. As parents, we are forced to become full time caregivers and
fundraisers, which puts a tremendous burden on the family, both
emotionally and financially.
When I found out that my precious little baby, Max, would die I
thought that was the end of the world. But, if anything could possibly
be worse, it was when I realized that in addition to living with this
disease my family and I would also have to financially support medical
research in order to give Max a chance. Due to the lack of funding from
our Government, we the parents of dying children, have worked
tirelessly raising money to pay for research that may help our children
enjoy a better quality of life, and possibly live longer.
While there are approximately ten families who actively raise money
for research, it is simply not enough to sustain our effort. For
example, my family has been aggressively fundraising for over three
years and founded a charity, Canavan Research Illinois. We have raised
just under a quarter of a million dollars. Though this may sound like a
lot of money, even when combined with funds from other Canavan
foundations, it does not compare to the astronomical costs of both
research and clinical trials. Orchestrating a safety trial is both time
consuming and costly. Together, families affected by Canavan disease
have raised over two and a half million dollars in five years, but we
will need seven million dollars over the next three years to continue
the research that we have started.
I have dedicated my life to working towards finding a cure for
Canavan disease. My husband, Michael, Max, and I live on one moderate
income, so I can work full time as an unpaid volunteer for the public
charity I co-founded. I have chosen this path because I believe a cure
can be found; it is just a matter time, and money. However, as the
mother of a very sick little boy there are many other demands on my
time. Max goes to school and therapy everyday, so I spend a great deal
of time in our van shuttling him from place to place. The time required
to be a full time caregiver for a profoundly handicapped child with
multiple disabilities is in itself a full time job. This is why I am
asking for your help. Help us find a cure, but also help us fund a
cure!
Medical research is too expensive to be funded solely by private
donations. We can no longer do it. We have exhausted our resources. Our
friends and family have generously donated money when they have been
asked, but this has decreased over time. We are out of resources, and
our children are losing precious time. Science cannot move ahead if it
is only supported by dinner dances, raffles, auctions, and donations
from friends. I get extremely discouraged when I work forty to fifty
hours a week fundraising to save my baby and then hear from our
privately funded researcher that we are out of money, again. This means
we are out of hope. I have worked too hard to stop now. So I am
pleading with you, Mr. Chairman that in addition to granting additional
funds to the NIH, that you encourage them to make a concerted effort to
look at granting more research funds towards medical interventions for
the young children afflicted with Canavan disease. The children who are
dying now deserve a chance.
While Canavan disease is rare, and may require millions of dollars
for medical research, the beneficiaries of this research are not
limited to the Canavan children. There are many related diseases that
will benefit from this research including: Alzheimer's, ALS,
Parkinson's, MS, Spinal Cord Injury, and Stroke.
Canavan disease is a very good model for neurodegenerative disease.
It is caused by a single mutated gene, which has been identified. The
defective gene in Canavan children is responsible for making one
enzyme, which also has been identified. If the doctors and scientists
had the funds necessary to expand our understanding of CD, we would be
able to develop a treatment or cure for it and apply this knowledge to
the other neurodegenerative diseases.
If you look at all the related diseases it is clear that research
in one area, will spill over and help research in another. But the
millions of dollars necessary for this to happen have simply never been
granted to the Canavan researchers who are working on treatments that
are ready to be used in human clinical trials. Testing mice and rats
for ten years will not help the people who are dying today. Because
there is no funding for the disease my son was born with, he does not
have access to any treatment.
I believe that every American is entitled to have access to some
course of medical treatment. The little children dying of Canavan
disease deserve a chance. Without Government funding they will not have
that chance. Many of these children are already medical pioneers and
have undergone experimental therapies to try and improve their lives,
and the lives of children in generations to come but, sadly this will
come to an end. The financial burden of supporting medical research is
too much for the friends and family of a dying child. Without
Government grants that will be used towards medical interventions for
the people who need help now, the science we have all so vigorously
supported will come to a screeching halt, and our children will die.
We need research dollars now. Our children are running out of time,
along with the other people who suffer from degenerative brain
diseases. We cannot do this alone! The millions of dollars necessary to
treat and cure Canavan disease will ultimately help millions of people.
Thank you for receiving my testimony.
______
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 continue the public/private partnership
with the Federal Government by the establishment of the ``Center for
Environmental Health Research and Service.'' This partnership will
cover the cost of the construction of a new, 113,000 square foot,
state-of-the-art facility which will house research in the fields of
asthma, inflammation, immunology, and environmental medicine. These
basic and clinical/translational research programs address issues that
are central to the mission of the Center for Environmental Health
Research and Services. The new research facility will be closely
integrated with the clinical care, outpatient services, and training
programs that our Center for Environmental Health Research and Services
uses to translate research to improve clinical services for patients
with respiratory and immune diseases such as asthma, lung fibrosis,
tuberculosis, and other lung and skin disorders which often stem from
environmental and occupational hazards.
The total cost of the proposed facility and equipment is $39
million. Since fiscal year 1999, National Jewish has received a total
of $3.75 million from the Labor, Health and Human Services, and
Education Appropriations Bill under HRSA to carry out the initial
phases for the construction of the CEHRS and has privately raised $29
million. National Jewish seeks $5.25 million in HRSA follow-on funding
in fiscal year 2002 to complete the balance of the construction
request.
______
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 with
congenital heart defects we enter this testimony for consideration at
the fiscal year 2002 budget hearing. The Children's Heart Foundation
formally requests to be allowed to testify before the subcommittee
during hearings on appropriations for fiscal year 2002 to the National
Institutes of Health.
According to the NIH Guide: PEDIATRIC DISEASE CLINICAL RESEARCH
NETWORK (release date May 24, 2000); about 32,000 babies are born each
year in the U.S. with congenital cardiovascular malformations (CCVM).
CCVM is considered the most common or number one birth defect and a
leading cause of death in infants. CCVM occurs at least three times
more often than childhood cancers and significantly more often than
pediatric AIDS. The mortality rate for these children may be as high as
fifty percent, depending on the condition.
The financial and social impacts on families are staggering. Many
children who survive infancy are forced into a life of dependency on
medications, medical procedures, and repeated open-heart surgeries.
Parents of these children will struggle with high medical costs and low
productivity when critical care is needed or when the child dies. This
trauma can throw a family into emotional and financial devastation. 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 deflects. According to
information provided by the NHL&BI, the direct cause for at leapt eight
different structural heart defects may be genetic.
While we at The Children's Heart Foundation applaud 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. For
this reason we urge this distinguished committee to encourage the NHLBI
to support more clinical research related to congenital heart defects.
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 request to testify before this committee under the
auspices of The Children's Heart Foundation.
ANDREA
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 that 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 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. 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 likes 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
proud to say I am now an Indiana University/graduate.
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 from
stress, but I later found out in the hospital that it 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. No one can
explain why I had two strokes after the Modified Fontan operation.
It is my hope that as more congenital heart research is performed,
researchers may discover why some people are more prone to having a
stroke than others and find a way to prevent them from occurring.
SAM
My name is Teresa Taylor from Skokie, Illinois and I would like to
address this committee on behalf of all the children born with
congenital heart defects, those surviving, and in honor of those that
have lost their lives including my son, Sam.
My son Sam and countless others that have died prematurely are not
forgotten but remembered. And to be a constant reminder for the need
for additional federal funding for research on congenital heart
defects.
Sam 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 birth defect. 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. 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 two 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 outcome. 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 have heard countless stories subsequent to our son'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.
JESSICA
My name is Jessica Cowin and I am 16 years old. I have had five
heart surgeries since I was four 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 four days and 18 months
the doctors performed closed heart surgeries on me. At five 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. I have missed a lot of school in the
past three years and I missed my friends, too.
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.
______
Prepared Statement of the City of Miami Beach, FL
Mr. Chairman: On behalf of the City of Miami Beach, Florida, I
appreciate the opportunity to submit written testimony on an extremely
important program the City has undertaken to serve its elderly
community both now and in the future. The City is seeking $500,000 in
fiscal year 2002 appropriations through the Administration on Aging for
the City's Elder Ready Community Pilot Initiative. We believe that this
pilot project can serve as a national model for aging services programs
as the nation's population continues to age.
ELDER READY COMMUNITY PILOT INITIATIVE
The Elder Affairs Office is part of the Housing Division of the
City of Miami Beach, a public entity. The office assists the elder
population in obtaining appropriate services through its information
and referral service. Staff also identifies and coordinates services
available in the community and serves as a liaison with other
governmental and community based organizations. In addition, the Elder
Services Initiative includes a needs and assessment that identifies
programs that will enhance senior life on Miami Beach.
As you may know, the City of Miami Beach has traditionally been a
destination for retirees. Over the last decade, the City has been
revitalized as a tourist destination and as a business center
attracting a younger resident population. At the same time, from 1990
to 2000, the population group ages 44 to 65 has increased from 19.4
percent to 23.2 percent of the City's total population. A key component
of the Elder Services Initiative is the Elder Ready Communities
Initiative that was developed by the Florida Department of Elder
Affairs and was officially announced during Older Americans Month, May
2000. It seeks to enhance recognition of both the value of elders to
Florida's communities and the need to plan for the accelerated
demographic changes over the next ten years as the ``baby boomer''
generation reaches seniority. In order to seek the designation of the
City as an Elder Ready Community, the Elder Affairs Office requests
direct funding through the to undertake a comprehensive assessment of
its elder community in regard to housing, transportation, city
infrastructure, the business community and the availability of
services.
The City of Miami Beach estimates that the cost of implementing an
Elder Ready Pilot Program will be $500,000. The City has currently
allocated an annual budget of $65,000 in general funds for its Elder
Affairs Programs. In addition, the City has committed fiscal year 2000/
2001 Community Development Block Grant funds in the amount of $90,000
and $65,000 in general funds to local providers of services to the
elder community.
At this time, the City of Miami Beach is not receiving funding for
this pilot program from any other Federal agency.
Florida is at the forefront of elder related issues that will
greatly impact the rest of the country during the next decade. Florida
has the largest proportion of elders of any state in the nation and all
projections indicate that this will continue to be the case for the
foreseeable future. The Florida Department of Elder Affairs leads the
country in its creation of the Elder Ready Communities Initiative. The
findings of this pilot project could be replicated in other
municipalities across the country as the population continues to age.
Through research, surveys and the ongoing commitment of the community,
new and innovative systems can be implemented for the health and
vitality of the entire City as well as for the rest of the country.
We hope you will find this critically important pilot project
worthy of your support.
Thank you for your consideration.
______
Prepared Statement of the City of Newark, NJ
Dear Mr. Chairman: The City of Newark, NJ hereby submits for the
record, testimony regarding three innovative projects that are of great
importance to the State of New Jersey's largest City. The projects
described below each address an aspect of the needs of Newark's low
income population. They are: (1) the Emergency Medical Services
Demonstration Project, (2) the Children's Health Care Services and
Outreach Center and (3) Babyland Family Services-A Solution to the
Digital Divide among Urban Families.
newark coordinated emergency medical services demonstration project
The objective of Newark's Coordinated EMS Demonstration Project is
to develop a coordinated model for a City-wide system for efficient
patient transportation and emergency services utilization, tracking and
billing. Funding is requested to assist in the design and
implementation of a system which will assure transportation of patients
to the appropriate specialty hospital or other medical facility. The
system will include a billing and service allocation component to
reduce inefficiencies and deter fraud, waste and abuse. The system will
be coordinated with the City's 911 integrated dispatch, to insure the
timely transfer of calls and delivery of services. The City's dispatch
center handles over 300,000 calls for service per year, and must
efficiently channel calls for medical service to the EMS system in a
manner that allows for tracking of services while transferring
operational responsibility. Over 100,000 calls for service per year go
to the Emergency Medical Services system in Newark.
Currently, the City of Newark contracts with the University of
Medicine and Dentistry of New Jersey (UMDNJ), through University
Hospital, to provide a complete system of dedicated 911 emergency
medical services. These services include: basic life support units
integrated with advanced life support services, emergency treatment and
transportation to local area hospitals as defined in an Approved.
Hospitals for Patient Transport policy, heavy rescue and vehicle
extrication, and service as the lead agency in response to mass
casualty incidents within the City. UMDNJ provides centralized medical
dispatch communications per NJ State requirements, and the interface
with City E911 services is crucial to both efficient and effective
dispatching, as well as to securing appropriate and adequate
reimbursement for services.
The combination of an increase in the number of calls for service,
tremendous advances in available technology, and pressures on the
billing system present both a challenge and an opportunity for a unique
demonstration project. The City of Newark's Police Computer Aided
Dispatch system is the central point for 911 emergency calls, and calls
to it for medical assistance are transferred to UMDNJ. However, calls
for assistance can also be placed directly to the emergency medical
assistance provider. There is no integrated system which can track all
calls, the disposition of them, and ultimately, the payment for them.
The reimbursements paid by the City, Medicaid, Medicare, the State's
Charity Care system, and managed care providers do not cover the cost
of capital expenditure for system upgrades. Further, the integration of
the City's E911 system with the UMDNJ system cannot currently be funded
through municipal sources, due to other needs and demands. The City is
now unable to track and verify EMS services and billing to residents
and/or third parties for which it is responsible. Therefore, an
allocation of $5 million is requested to establish a much needed
demonstration project for an integrated system for coordinated delivery
of emergency medical services.
NEWARK CHILDREN'S HEALTH CARE SERVICES AND OUTREACH CENTER
The objective of the Newark Children's Health Care Services and
Outreach 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. The Children's Health Care Services and Outreach 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. 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 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 Services and Outreach Center as a consumer friendly service
center.
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 one-fifth 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.
In addition to services available at the Center, there will be an
outreach team that will provide Newark residents with a mechanism that
will link them to all services currently provided within the City of
Newark, and that are identified through the focus groups. Teams will be
assigned to identified neighborhoods, and will be comprised of a Public
Health Nurse, Social Worker and Outreach worker. The teams will be
responsible for visiting Newark children as well as older residents and
assessing health and service needs. Working in coordination with
neighborhood community based organizations, city-wide faith based
agencies and area hospitals, citizens will be provided with referrals
for care and services. There will be specific emphasis on reaching
young mothers and their children who have not been previously involved
with the health care system and available services.
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
from the Centers for Disease Control (CDC) to support this initiative.
BABYLAND FAMILY SERVICES, INC.
THE NEWARK PROJECT: A SOLUTION TO THE DIGITAL DIVIDE AMONG URBAN
FAMILIES
The purpose of this initiative is to serve as a model educational
program that closes the ``digital divide'' among minority inner city
children and families. This technological network links center and
home-based child care centers and schools; 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 focus of this initiative is to establish the telecommunications
linkages necessary for the educational development of 1,000 preschool
and school-age children and to provide computer and technology training
for 2,000 parents, teachers, family service workers and entry-level
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.
Background: 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.
Babyland has been a major non-profit child and family service
organization in Newark, New Jersey for over 33 years and currently
provides comprehensive child and family development services to 1,500
at-risk children and their families each year. BFS programs provide a
continuum of educational services to individual children from infancy
to 18 years old (including teenage mothers and young fathers) as well
as multiple support services for family members. The agency is able to
build extensive relationships with families and to provide follow-up
care. As a result, Babyland 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. This
technology initiative will assist clients who have no other tangible
means of becoming computer literate and of acquiring the requisite
skills necessary to be informed and self-sufficient.
Specific Provisions
--Technology Center, as part of a new multi-purpose community
resource and education center, that will provide distance
learning, online and network linkages to educational
institutions and community resources, professional development
and training in basic and advanced computer and technology
skills for low-income parents, neighborhood residents and
entry-level employees.
--Technology hardware and software (technical assistance, network
installation and expansion, wiring, modems, printers etc.) for
children, parents and residents, and teaching/social service
staff in classrooms, homes, family resource centers and safe
havens.
--Technology Training, Curriculum Development and Professional
Development for children, parents and residents, educational
and social services staff, as well as local, State, national
and international community-based family service providers.
The initiative will benefit the following
--Children at nine child care centers (850 preschoolers) and 400
school-age children (charter school and after school/summer
enrichment programs) at six centers and schools.
--Parents and family members (2,000) at 14 Babyland sites with links
to community resources;
--Agency Staff (300), including teachers and family service workers,
for client tracking purposes; training and professional
development; and access to community resources to be provided
through workstations, wireless technology and/or palm pilots.
--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 Newark, New Jersey,
the nation and South Africa, who will receive training in
child, family and community development.
Key Outcomes
--Enhanced early childhood development and education for children
(three to 13 years old).
--Enhanced ability of inner city residents, especially low-income
parents and teenagers, to learn computer and technology skills.
--Enhanced tracking of 1,500 children in center- and home-based child
care facilities; teenage parents; victims of domestic violence;
homeless families; and children in foster care.
--Enhanced delivery of professional development of teaching and
family service staff.
--Enhance the provision and delivery of parent education programs.
--Enhanced delivery of clinical and therapeutic services to parents
and children.
--Enhanced ability to fulfill State and Federal reporting
requirements and to provide community development consultation
to local, State, national and international family service
providers.
This project received an allocation of $723,000 in the last fiscal
year. But in order for the system to be fully operational and
implemented for the entire target clientele population, an additional
allocation of $2 million is being sought.
The City of Newark wishes to express its deep appreciation to this
Committee for permitting the presentation of these important projects.
Your positive response for Newark's request for support will have a
positive impact on the health and well-being of Newark's citizens.
______
Prepared Statement of Mississippi State University
Mr. Chairman and Members of the Subcommittee, thank you for the
opportunity to submit this testimony regarding the National Institutes
of Health Institutional Development Award (IDeA) program. I am Dr.
Robert Altenkirch, and I am Vice-President for Research at Mississippi
State University. I also serve as EPSCoR State Project Director in
Mississippi. I submit this testimony on behalf of the Coalition of
EPSCoR States.\1\
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\1\ Alabama, Alaska, Arkansas, Idaho, Kansas, Kentucky, Louisiana,
Maine, Mississippi, Montana, Nebraska, Nevada, North Dakota, Oklahoma,
Puerto Rico, South Carolina, South Dakota, Vermont, West Virginia, and
Wyoming.
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I would like first to express my gratitude to Senator Cochran for
his strong support of the IDeA program and the related Experimental
Programs to Stimulate Competitive Research (EPSCoR) in other federal
agencies. Senator Cochran has been a strong advocate of IDeA because he
understands the importance of enhancing our nation's biomedical
research infrastructure by building the research capacity of
Mississippi and the other IDeA states. We Mississippians greatly
appreciate his leadership on IDeA and a whole host of issues important
to Mississippi. We are proud to have him represent us in the United
States Senate.
IDeA was authorized by the 1993 NIH Revitalization Act (Public Law
103-43). IDeA works to improve our nation's biomedical research
capacity by enhancing the capability of states that have not yet
substantially participated in the NIH's research endeavors. The NIH has
identified the following states as eligible for IDeA funding: Alaska,
Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine,
Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico,
North Dakota, Oklahoma, Rhode Island, South Dakota, South Carolina,
Vermont, West Virginia, Wyoming and the Commonwealth of Puerto Rico.
IDeA acknowledges that nearly one-half of the states do not have an
adequate R&D infrastructure in the biomedical sciences. Clearly this is
not in the long-term best interest of our nation.
IDeA is important, Mr. Chairman, because NIH research funds are
extremely concentrated geographically. The 24 states that participate
in IDeA received just 5.3 percent of NIH research funding over the
fiscal year 1994-fiscal year 2000 period, while the top state alone
received nearly three times that amount. The five most successful
states combined received 48 percent of NIH funding over the same
period.
For example, according to data compiled by the Social Science
Research Center at Mississippi State University, Mississippi received
$20 million in NIH research funding in fiscal year 1999, compared with
a national average of nearly $250 million per state. Alaska received
just $2 million, Idaho received $3 million, and New Hampshire received
$50.3 million--all a fraction of the national average.
Our country has embarked on a great endeavor: to increase
substantially the NIH research budget--possibly even doubling research
funding over the next five to seven years. Many scientists and Members
of Congress support this worthy goal, and I applaud this important
effort.
While I strongly support efforts to increase biomedical research
funding, I think it crucial that all regions of the country participate
in this effort--not just existing centers of excellence in a small
handful of states. If we are to double research funding we need to
enhance our research capacity by including a greater portion of the
country in our research endeavors. Every region of the country has
talent to contribute to our nation's biomedical research efforts--and
every region of the country should have the opportunity to nurture and
develop their talent pool into individuals and centers that can compete
successfully for NIH funding and develop the biomedical R&D base across
our nation.
The 24 IDeA states have fine research institutions that are home to
many talented researchers. The institutions and researchers in these 24
states should play a significant role in our nation's effort to expand
research capacity; they are crucial to any serious effort to improve
our nation's ability to treat, cure and prevent disease.
Mr. Chairman, the Congress provided the NIH with $20.3 billion in
fiscal year 2001--an increase of $2.5 billion or 14 percent above the
fiscal year 2000 level. It is the largest increase that NIH has ever
received, and I understand the NIH could receive an increase this year
as well. Mr. Chairman, the Subcommittee was helpful last year in
providing IDeA with an increase, and we sincerely appreciate the
Subcommittee's support. While last year's appropriation for IDeA is
definitely a step in the right direction, we believe IDeA should be
funded at $200 million or more.
We ask you to provide $200 million for IDeA in fiscal year 2002--a
small fraction of the likely NIH increase. Building the research
capability of the 24 IDeA states is crucial toward the goal of
increasing and enhancing our nation's research capability. On behalf of
the Coalition of EPSCoR States, I thank the Subcommittee for the
opportunity to submit this testimony.
______
Prepared Statement of the Coalition for Health Funding
Mr. Chairman, the Coalition for Health Funding is pleased to
provide the Subcommittee with testimony recommending fiscal year 2002
funding levels for the agencies and programs of the Public Health
Service. Since 1970, the Coalition's member organizations, representing
40 million health care professionals, researchers, lay volunteers,
patients and families, have been advocating for adequate resources for
the agencies and programs within the Public Health Service. The
Coalition for Health Funding is the nation's oldest, most broadly based
alliance focused on the breadth of discretionary health spending.
The Coalition sincerely appreciates the strong and continued
support that the Subcommittee has given to health discretionary
programs in the past. The Coalition recognizes the considerable funding
limitations that the Subcommittee is likely to face in fiscal year
2002, but the Coalition urges you to seize every opportunity, as the
process moves forward, to fund increases for critical public health
programs.
On the cusp of the second year of the 21st Century, the nation, and
the world, are at an unprecedented nexus of great promise and potential
disaster. If we devote adequate resources to research opportunities at
the National Institutes of Health we have the potential to advance our
understanding of the biological basis of disease and unlock new
strategies for disease prevention, diagnosis, treatment and cures. But
we will not fully reap that potential for all Americans if we do not
also invest in the other agencies and programs of the U.S. Public
Health Service. We will not fully reap our investment in biomedical and
behavioral research if we do not also invest in a strong public health
infrastructure at the local, state, and federal level; translate
biomedical and behavioral research into community-based prevention
strategies; provide needed services for medically underserved
populations; assure a well-distributed health and public health
workforce in adequate numbers; and develop and translate the most cost-
effective implementation of biomedical and behavioral research into
medical practice. If we do not also do these things we risk disaster in
the form of soaring medical care costs as the cohort of baby boomers
ages with a host of preventable chronic diseases and there are not
enough nurses, and other essential health care personnel, to care for
them. We risk disaster if we do not continue to strengthen our
seriously weakened public health infrastructure at the local, state and
federal levels to prepare for a bioterrorist attack, a major outbreak
of infectious disease such as the world experienced in the 1918 with
pandemic flu, and to curb rapidly growing resistance to antibiotics
used to treat serious bacterial infections. We risk disaster if we do
not continue to try to meet growing demand for basic health and medical
care services, particularly for mothers and children. A community is
only as healthy as its weakest members. Failure to fully immunize
children, adolescents, and vulnerable adults puts everyone at risk.
Failure to respond to the health, mental health, and substance abuse
needs of millions of uninsured Americans undermines the health of our
workforce and undermines the health of our economy.
These are the major public health challenges ahead in the 21st
Century. To address them and reap the potential of enormous positive
returns requires adequate investment across the continuum of public
health activity. The coalition's members recognize that no one
component of the public health continuum can be effective in achieving
the overall goal of improved health outcomes without the strong support
of the components.
Each year, the Coalition for Health Funding works with other health
alliances to determine an appropriate level of federal support for all
health discretionary programs. For fiscal year 2002 the Coalition is
recommending $44.2 billion be provided to address the nation's needs in
the areas of biomedical, behavioral, and health services research;
disease prevention and health promotion; health services for medically
underserved populations; health professions education; and substance
abuse and mental health services. The Coalition's recommendation also
includes funding for the Indian Health Service and the Food and Drug
Administration, which are not within the jurisdiction of this
Subcommittee, but are important agencies within the U.S. Public Health
Service. The Coalition appreciates that these funding levels, 20
percent over fiscal year 2001, may appear excessive, but they reflect
both the professional judgment within the various agencies as well as
our own members' assessment of community and national need. The
Coalition presents these recommendations to the Subcommittee in the
hope that it will view them as important targets for optimal health
outcomes.
The following is a partial list of the Coalition's findings and
recommendations; the attached table provides the Coalition's
recommendations for all the public health agencies:
NATIONAL INSTITUTES OF HEALTH (NIH)
The Coalition supports an additional $3.4 billion in funding for
NIH in fiscal year 2002, for a total of $23.7 billion, as the fourth
installment toward doubling the NIH budget by 2003. But in recognition
of the difficulty in achieving this goal, the Coalition cautions that
this increase must not come at the expense of other public health
programs.
The Coalition recognizes the critical importance of the research
conducted at the NIH and that increases provided in fiscal year 1999,
2000, and 2001 must be continued in order to fully reap our investment.
Three main reasons for continuing on the path to doubling the NIH
budget include the many research challenges still confronting us, the
burgeoning scientific opportunities that are now available in this
post-genomic world, and the large economic benefits that accrue as we
make progress against diseases. Examples of past investments in NIH
research that have yielded important benefits include identifying a
gene that contributes to susceptibility to type 2 diabetes, developing
a vaccine to nearly eliminate infections caused by Haemophilus
influenzae type b, using magnetic resonance imaging (MRI) measurements
to predict who will get Alzheimer's disease, making landmark strides in
the diagnosis and treatment of depression and schizophrenia, uncovering
a hormone involved in the onset of osteoporosis, and growing
replacement heart valves in the laboratory.
The Coalition appreciates that medical research is a vision not a
precise blueprint. It must be flexible enough to respond to society's
changing health care needs and dynamic enough to open the way to ever
more promising frontiers of fundamental research. Scientific
discoveries are the result of a series of incremental steps that pave
the way for future breakthroughs. This process needs sustained support.
With it, and support for other public health partners, we will be ready
to meet the challenges of the future.
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
The Coalition for Health Funding recommends an overall funding
level of $5 billion for CDC in fiscal year 2002. The Coalition believes
this is the amount needed to enable CDC to carry out its vital mission
of disease prevention and health promotion.
The Coalition is very pleased that Congress provided $181 million
in fiscal year 2001 to continue the process of re-building the nation's
seriously eroded public health infrastructure in order to prepare for
bioterrorism. The Coalition notes that landmark legislation passed last
year, the Public Health Threats and Emergencies Act, builds on the
three years of bioterrorism funding, to further strengthen public
health infrastructure at all levels of government, but particularly the
local and state levels. The Act authorizes $524 million in fiscal year
2002 to address three major threats: bioterrorism, antimicrobial
resistance and major infectious disease outbreaks. The Coalition urges
the Subcommittee to provide full funding for this critical effort;
strengthening basic public health capacity also lays a foundation for
addressing all disease and disabling conditions.
CDC administers many programs that utilize the research findings of
the National Institutes of Health, and other public health agencies and
programs, to develop community-based strategies to prevent disease and
disabling conditions and promote improved health. Programs needing
increases include those addressing chronic and environmental diseases
such as cardiovascular diseases, diabetes, cancer, and asthma. This
program line received a substantial, 40 percent increase in fiscal year
2001, but because there are over 40 separate programs included, some
received significant increases, others small increases, and some no
increases. Chronic diseases combined constitute the nation's most
costly health problem, but we still do not reach all states with
adequate funding to implement cost-saving and life-enhancing prevention
efforts.
In the area of infectious diseases, the Coalition believes that
significant increases are needed to enable CDC to fully implement its
comprehensive plan, `` Preventing Emerging Infectious Diseases: A
Strategy for the 21st Century.'' In today's global society, it is
possible for a new disease to spread internationally within days,
perhaps hours. Since 1973, more than 35 new infectious diseases have
been identified, including E. coli 0157:H7, airborne Ebola virus, and
West Nile virus. Serious challenges lie ahead as these newly emerging
and re-emerging diseases are identified, while at the same time, multi-
drug resistant organisms, such as Staphylococcus aureus, proliferate.
More than 90 percent of strains of Staphylococcus aureus in U.S.
hospitals are resistant to penicillin. In some areas of the United
States, more than 30 percent of the pneumococci resist penicillin, a
drug once effective against almost all pneumococcal pneumonia and
meningitis.
Increases are also needed for prevention of HIV transmission, which
is receiving new focus within CDC. Prevention of HIV transmission is
our best defense against the AIDS epidemic that has already killed over
400,000 U.S. citizens and is devastating the populations of nations
around the globe. There are 40,000 new infections every year with one-
half occurring in individuals under the age of 25.
Elimination of TB and STDs, especially syphilis, are now within our
grasp. These welcome opportunities, if adequately funded now, will save
millions in annual health care costs in the future.
Finally, also in the area of infectious diseases, significant
increases are needed for immunization. An important IOM report on
immunizations published last year entitled, Calling the Shots, stated
that unstable funding for state immunization programs threatens
coverage for specific populations and age groups. The report
recommended an increase of $75 million for CDC's operations/
infrastructure state grant program. Congress provided $42.5 million of
this increase in fiscal year 2001; the full increase is needed in
fiscal year 2002. In addition, significant increases are also needed
for the domestic vaccine purchase program to meet the costs of the
newly recommended pneumococcal conjugate vaccine, as well as the costs
of expanding vaccines to the 1 million two-year-olds that are not fully
vaccinated, and to adolescents and adults. Finally, increases are also
needed for CDC's global immunization program.
In response to legislation enacted last year, CDC has created a new
Center on Birth Defects and Developmental Disabilities. This exciting,
strengthened focus on many preventable diseases and disabling
conditions, as well as on improving the lives of those who live with
disabilities, also needs new resources.
The Preventive Health and Health Services Block Grant is the only
source of flexible funding to enable state public health officials to
achieve Healthy People 2010 goals, address health gaps in discretionary
funding, and respond to unexpected crises such as the emergence of West
Nile Virus. The Block Grant was cut nearly $15 million (10 percent) in
fiscal year 2000 to $135 million and level funded in fiscal year 2001.
State health officials are requesting a 50 percent increase in the
Prevention Block Grant for fiscal year 2002.
Prevention Centers and Prevention Research, important programs in
the nation's foremost health prevention agency, should receive
significant increases reflecting their importance. Prevention research
is mentioned as a priority area in President Bush's February budget
blueprint.
Other important programs needing increases are: the National Center
for Health Statistics, NIOSH; health disparities demonstration
research; and injury control.
HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)
The Coalition for Health Funding recommends an overall funding
level of $6.7 billion for HRSA in fiscal year 2002. This is the total
funding level that the Coalition believes is needed to provide adequate
resources for the important programs that HRSA administers that address
access to needed medical and health care services for medically
underserved populations.
The Coalition is pleased that the President has expressed his
support for the effort to double funding for the Consolidated Health
Centers program over the next five years. Last year, Congress provided
the first down payment on this goal bringing the current funding levels
to $1.169 billion. The Coalition for Health Funding supports a second
down payment in fiscal year 2002 to help reach the goal of building
1,200 new health center sites and doubling the patient capacity of the
entire health center program over the next five years.
The Coalition's recommendation also includes increases for the
programs of the Ryan White CARE Act. HIV/AIDS is an extremely serious
epidemic facing Americans and people throughout the world. The programs
of the Ryan White CARE Act target needed health care, and other support
services, including expensive drug therapies, to Americans suffering
from HIV/AIDS.
The Coalition supports an increase for the Title X family planning
program in fiscal year 2002. This funding would support 4,600 family
planning clinics across the United States. It would pay for
comprehensive services including screenings for cancer, HIV, and other
diseases as well as contraception, and teen pregnancy prevention
including educational activities that encourage young people to
postpone sexuality.
Preliminary information indicates the President's budget may cut
funding for Graduate Medical Education for free-standing children's
teaching hospitals which was a new initiative in fiscal year 2000, and
received $235 million in funding in fiscal year 2001. This important
program that trains physicians that provide direct care for children,
needs to continue, and needs increased, not decreased, funding. The
Coalition also supports increased funding for the Children's Emergency
Medical Services program which ensures that emergency care provided for
children is appropriate for their specific needs, and funding at the
authorized level for HRSA's new trauma care program.
The Coalition is disappointed that the Maternal and Child Health
Block Grant has been level funded for the past several years at $710
million. 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 largely to two trends: continued growth in the
numbers of uninsured that is outpacing targeted efforts, such as the
Child Health Insurance Program, to cover them; as more eligible
children for CHIP are identified, often by MCH outreach efforts, more
children are identified as needing MCH services. This increased demand,
and the findings of a recent Institute of Medicine report entitled,
From Neurons to Neighborhoods, which concludes that new science about
early childhood development demonstrates urgent need to expand the kind
of services that the MCH Block Grant provides, the Coalition believes
this program should be funded at its fully authorized amount in fiscal
year 2002.
The Coalition is also very disappointed that the President's budget
blueprint proposes to cut the Health Professions and Nursing Education
Programs. These programs provide support to students, programs,
departments and institutions to improve the racial and ethnic
diversity, accessibility, and quality of the health and public
healthffff workforce. In particular, these programs help meet the
health care delivery needs of over 2,800 Health Professions Shortage
Areas in this country, at times serving as the only source of health
care in many rural and disadvantaged communities. The Coalition
believes this program needs increased, not reduced, funding in fiscal
year 2002.
The Coalition sincerely appreciates this opportunity to provide its
fiscal year 2002 funding recommendations to the Subcommittee for the
agencies and programs of the U.S. Public Health Service. The
Coalition's recommendations for all of the public health agencies is
provided in the accompanying table. The Coalition, and its member
organizations, look forward to working with the Subcommittee in the
weeks ahead to improve the health of all Americans.
DISCRETIONARY HEALTH PROGRAMS
[B.A. in millions of Dollars]
----------------------------------------------------------------------------------------------------------------
Fiscal year
--------------------------------
2001 2002 CHF Difference Percent
appropriation recommendation
----------------------------------------------------------------------------------------------------------------
CDC............................................ $3,868 $5,000 +$1.1b +29
NIH............................................ 20.3b 23.7b +3.4b +16.7
HRSA........................................... 5,557 6,700 +1.1b +20
SAMSHA......................................... 2,958 4,057 +1.1b +37
AHRQ........................................... 270 400 +130m +48
FDA............................................ 1,217 1,399 +182m +15
IHS............................................ 2,598 2,848 +250m +9
OPHS........................................... 165 181 +16m +9
----------------------------------------------------------------
Total Public Health...................... 36,933 44,285 +7,352 +20
----------------------------------------------------------------------------------------------------------------
______
Prepared Statement of the Coalition of Northeastern Governors
The Coalition of Northeastern Governors (CONEG) is pleased to
provide testimony for the record to the Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and Related
Agencies as it considers fiscal year 2002 and advance fiscal year 2003
appropriations for the Low Income Home Energy Assistance Program
(LIHEAP). The CONEG Governors appreciate the support provided by the
Subcommittee in maintaining this important program, and urge the
Subcommittee to increase funding for both fiscal year 2002 and advance
funding for fiscal year 2003 to the full authorized level. In addition,
we are requesting that the full authorized funding authority be
provided for each year to allow for the release of emergency funds for
unforeseen circumstances, such as price spikes in natural gas or
heating oil, severe weather and other potential emergencies.
During the current fiscal year, LIHEAP has played an essential role
in making home energy affordable for the region's very low-income
households--the elderly and disabled on fixed incomes, families with
young children, and those making the difficult transition from welfare
to work. Two-thirds of the region's LIHEAP recipients have annual
incomes of less than $8,000 per year. For many of these households,
annual income is not sufficient to pay high winter heating bills, even
in periods of economic growth. Many low-income residents are forced to
choose between heating their homes or purchasing food or vital
medications.
The recent rise in winter heating fuel prices has hit these
vulnerable citizens especially hard. Price volatility adversely affects
the low-income households who, without disposable income to purchase
fuels off-season, typically enter the market when demand and price are
high. The percentage of household income spent on energy by low-income
residents can be significant. Program funds are targeted to those
households with high energy burdens, averaging 18 percent of household
income--compared with 6.7 percent for all households.
This increase in the price of home heating fuels has created a
heightened demand on the states' LIHEAP programs. The projected need
far outweighs the available funding. States in the region have seen
increases as high as 33 percent in their regular caseloads as well as
significant increases in requests for emergency assistance from those
households in imminent danger of a fuel service cut-off.
The $600 million in LIHEAP contingency funding provided by Congress
in the fiscal year 2000 supplemental appropriations bill was essential
in ensuring that low-income households could heat their homes this
winter, and the states are deeply appreciative of Congress' action.
Even with these contingency funds, the program currently serves less
than 20 percent of citizens who qualify for LIHEAP assistance. While
there will always be true crises that call for emergency funding, an
increase in the regular LIHEAP appropriation for fiscal years 2002 and
2003 to the full authorized amount will enable the states to more fully
implement cost-effective measures to meet the continuing energy needs
of the region's most vulnerable citizens.
State LIHEAP programs could stabilize heating fuel prices for low-
income households and expand the reach of limited program funds if an
agency could achieve some form of price protection through contracting
with retailers on a fixed or ceiling price basis when heating oil
prices are most attractive. Today, these ``pre-buys'' are difficult to
do, since the programs face the constraints of limited or no funds to
carry forward to a new heating season, and the new funds are not
available until October 1 of each year. A federal appropriation, and
advance funding, to the full authorized level would allow states to
manage the program resources in a manner to better take advantage of
retail contracts.
As you know, the fiscal year 2001 Labor, HHS and Education
appropriations bill did not contain advance fiscal year 2002 funds for
LIHEAP. Enactment of advance funding is vital to the states' program
planning activities for the coming heating season. In the Northeast,
where the heating season begins in early October, states generally
spend up to 70 percent of the LIHEAP funds during the first two
quarters of the fiscal year. States must be prepared to begin their
LIHEAP program as soon as the new fiscal year starts. Advance funding
permits them to do this, even when Congress has not yet enacted the
Labor, HHS and Education appropriations bill for the new fiscal year.
Our states have aggressively planned for a colder winter and higher
heating fuel prices. LIHEAP programs opened early and states undertook
aggressive outreach campaigns urging customers to conserve energy and
explore fuel price protection options. States have designed their
LIHEAP programs to make the most efficient use of funds by coordinating
with weatherization and leveraging programs. In cooperation with
federal officials and the winter fuels industry, CONEG conducted a
winter fuels emergency simulation exercise to ensure that our states,
federal agencies and the industry will be prepared to anticipate and
effectively manage winter fuel supply emergencies which may arise.
These preparedness activities, while critical, cannot fully shield
our lowest-income citizens from the impacts of higher heating fuel
prices. Your support for increased LIHEAP appropriations to the full
authorized level and the enactment of advance appropriations is
urgently needed to enable our states to help mitigate the potential
life-threatening emergencies and economic hardship that confront the
region's most vulnerable citizens.
We thank the Subcommittee for this opportunity to share the views
of the Coalition of Northeastern Governors, and we stand ready to
provide you with any additional information on the importance of the
Low Income Home Energy Assistance Program to the Northeast.
______
Prepared Statement of College on Problems of Drug Dependence, Inc.
Thank you Mr. Chairman and Members of the Subcommittee for the
opportunity to present written testimony for the record. My name is
Charles Schuster and in addition to being a Professor of Psychiatry and
Behavioral Neuroscience and Director of the Wayne State University
Addiction Research Institute, I am the President of the College on
Problems of Drug Dependence (CPDD). The CPDD, formerly the Committee on
Problems of Drug Dependence, has been in existence since 1929 and is
the longest standing group in the United States addressing problems of
drug dependence and abuse. From 1929 until 1976, the CPDD was
associated with the National Academy of Sciences, National Research
Council. Now the CPDD functions as an independent organization with
over 600 members representing all of the scientific disciplines and
medical specialties concerned with understanding the etiology and
consequences of drug abuse and based upon this understanding the
development of effective prevention and treatment interventions.
As part of its function the CPDD serves as an interface among
governmental, industrial and academic communities maintaining liaisons
with regulatory and research agencies as well as educational,
treatment, and prevention facilities in the drug abuse field. CPDD also
serves as a collaborating center for the World Health Organizations
Drug Abuse Advisory Committee and members of the CPDD Board of
Directors have served as an Expert Advisory Group to the Office of
National Drug Control Policy.
Since 1938, a major focus of the CPDD's activities has been its
sponsorship of an annual scientific meeting. This conference serves as
a forum bringing together basic scientists, clinical investigators from
industry, academia, and government. Representatives of regulatory
agencies and other policy makers, as well as scientists and
professionals in a number of diverse disciplines interested in the
biochemical, behavioral, and public health aspects of drug dependence
participate. This year I am pleased to note the Center for Substance
Abuse Treatment/SAMSHA has supported the participation of community
treatment practitioners. This support will enable us to bridge the gap
between academic researchers and drug abuse treatment practitioners to
facilitate the application of new science-based treatment and
prevention interventions in community treatment programs.
The National Institute on Drug Abuse/NIH is a governmental
organization that is very important to CPDD because it supports the
overwhelming majority of the scientific research on the biopsychosocial
problems associated with drug abuse and dependence. These research
efforts are rapidly increasing our knowledge about the etiology and
consequences of drug abuse and providing a science base for the
development of more effective prevention and treatment interventions.
There are a number of areas of NIDA sponsored research ranging from the
basic to the applied that are making a difference. However, time
permits me to mention only a few of these today.
NEUROTOXICITY
Many years ago my colleagues and I at the University of Chicago
reported that high doses of methamphetamine (speed, crack) causes
irreversible damage to dopaminergic and serotonergic neurons in the
brains of laboratory animals. Although this uniform finding across
diverse-animal species suggests that similar effects would be found in
humans it is important to firmly establish this conclusion. Today,
using modern techniques for the non-invasive study of the human brain
(Positron Emission Tomography, functional Magnetic Resonance Imaging
and Magnetic Resonance Spectroscopy) is allowing NIDA sponsored
researchers to explore this premise and definitive answers are
imminent. In addition, NIDA sponsored research is currently using these
imaging techniques to determine the type of brain changes that take
place when drug abusers are exposed to high doses of other drugs such
as cocaine, MDMA (Ecstasy) and heroin, whether these changes are
irreversible and their functional consequences. The recent emergence of
the problems of teen-age abuse of MDMA and other ``Club Drugs''
exemplifies the ever-changing challenges which face the NIDA.
BEHAVIORAL TREATMENT INTERVENTIONS
Such basic knowledge informs and improves efforts to develop
treatments of drug dependence. Treatments of all varieties and various
combinations are important for promoting abstinence for the drug abuser
and dependent patients. Behavioral treatments are one area of many
where NIDA has been very successful and effective in adding to our
``treatment toolbox''. Behavioral treatments emphasize that treatment
must address multiple factors in an individual's life that support drug
use and rearrange them so that they support abstinence. Such successful
treatments have shown that teaching skills, supporting change, and
providing incentives can produce both immediate and long lasting
abstinence in the drug-dependent patient. NIDA sponsored researchers
are applying these important innovations to an ever increasing array of
conditions and patients. Among the most important of these is the
pregnant addict. Behavioral treatments that promote abstinence in
pregnant mothers not only help the mother, but prevent a plethora of
problems in the developing baby. Such efforts show the success of
developing treatments and exemplify the broad impact they can have not
only today but also in tomorrow's generation.
NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK (NIDA-CTN)
Developing successful treatments are important, but so is the
dissemination and utilization of those treatments. Over the past two
years NIDA has established a network of 14 university-based research
centers, each of which are affiliated with 5-10 community treatment
programs (CTP's). Behavioral and pharmacological treatments, alone and
in combination which have been shown to be efficacious in NIDA
sponsored controlled clinical trials will be evaluated for their
``usefulness'' in these CTP's. Those that are found to be useful will
be disseminated to treatment programs throughout the United States. In
this way the NIDA-CTN will facilitate the utilization of the most
effective treatments for all those seeking to overcome their drug
dependence problems. If funding is available, we understand that NIDA
plans on expanding this system to have an even greater impact on the
quality of drug abuse treatment available throughout the country. The
College urges you to support funding for NIDA at $991.7 million in the
fiscal year 2002 Labor, Health and Human Services Appropriation Bill,
which represents a 27.0 percent increase over current funding.
This increase will allow for the expansion of the CTN while at the
same time providing the necessary funding for research which will lead
to the development of new treatment interventions that the CTN will
evaluate.
The members of the College on Problems of Drug dependence want to
thank this Subcommittee for your steadfast support of the NIH in
general and the National Institute on Drug Abuse in particular. We
believe that the federal governmental investment in drug abuse research
is extremely wise. Every individual in this country is effected either
directly or indirectly by the problems associated with drug abuse.
Economists estimate that drug abuse costs our society over $100 billion
dollars each year. But dollars cannot portray the tragedies that drug
abuse cause for the individual, their families and the communities in
which they live.
I have seen the tragic consequences of my son's involvement with
the criminal justice system because of his illicit drug use. The good
news is that research has shown that drug abuse can be prevented and
effectively treated. Clearly there is room for improvement in our
ability to prevent and treat the problems of drug abuse/dependence.
This is why additional research is needed. Basic research to better
delineate the social and biological factors that make some young people
vulnerable to the addictive properties of drugs of abuse. A thorough
understanding of these etiological risk factors for drug dependence
will make it possible to improve our prevention efforts especially for
those who are most vulnerable for addiction. Basic research is
essential for understanding what changes in the brain take place in the
transition from sporadic abuse of drugs to the compulsive use
characterizing drug dependence. This knowledge will help us to target
the brain neurochemical systems that must be treated with medications
if we are to reverse the addiction process.
Finally, basic research is needed to delineate the long term
neurotoxic consequences of exposure to drugs of abuse so that we can
develop therapies to assist individuals so afflicted to function
optimally. Hopefully the insights provided by this basic research will
lead clinical researchers in the development of new effective
pharmacological and behavioral interventions for the treatment of all
forms of substance abuse/dependence. Research has already shown that
currently available empirically based prevention and treatment is the
most cost-effective means of curbing drug abuse. Clearly supporting
research that will further improve our ability to prevent and treat the
problems of drug abuse will pay handsome dividends both financially and
for the morale of our country. CPDD therefore asks this Subcommittee to
seriously consider funding NIDA at $991.7 million for fiscal year 2002.
We recognize that there are many competing demands for federal funds
but strongly believe that this area is of the highest priority.
It must also be stated that the membership of the College on
Problem of Drug Dependence is concerned about the adequacy of funding
for drug abuse prevention and treatment services. We therefore request
that you provide increased funding for the Center for Substance Abuse
Prevention and the Center for Substance Abuse Treatment to insure that
they are able to provide the support necessary to provide all of our
citizens the very best services possible.
Thank you for the opportunity to present the views of the
membership of the College on Problems of Drug Dependence to this
Subcommittee.
______
Prepared Statement of Community Medical Centers, Fresno, CA
Mr. Chairman and Members of the Subcommittee: My name is Dr. Philip
Hinton and I am Chief Executive Officer of Community Medical Centers in
Fresno, California. Community Medical Centers is a not-for-profit,
locally owned healthcare corporation that is committed to improving the
health of the community. I am pleased to provide the subcommittee with
a request for assistance in securing federal monies for a critical
project in the Central San Joaquin Valley that would improve healthcare
delivery to the growing Hispanic and minority populations by creating a
network of clinics accessible to the rural areas. These populations in
the five county area of Fresno, Madera, Tulare, Kings and Mariposa face
some of the most devastating and worst health outcomes in the state of
California and in the nation:
--the third highest asthma mortality rate in the nation;
--the highest rates of teen pregnancy in the state;
--the highest incidence of diabetes among the Hispanic population
--late or no prenatal care for pregnant women
--greater likelihood for newborns to be of low birth weight than the
rest of the state
--some of the lowest immunization rates in the nation (62 percent at
age 2 versus 79 percent nationally)
--the highest rates of syphilis in the state.
These health outcomes are not acceptable and yet they exist because
of the following reasons:
Limited access to care
--Low ratio of primary care providers to population. Fresno County
has 178 physicians/100,000 population vs. 235/100,000 in the
state.
--Virtually no specialist care located in rural areas
--Isolation of rural communities from urban areas and poor public
transportation.
Financial constraints
--Many people are without health insurance
--Accessing healthcare in the urban areas results in a day's lost
wages
--Lack of childcare providers means that patients must bring their
entire family with them when they visit the clinic.
Educational issues concerning health
--Lack of understanding of preventive care
--Cultural barriers to addressing health issues before they become
acute crisis
Language barriers
--Over 100 languages are spoken in the area
Coupled with high unemployment rates that are twice the state and
three times the national average, and adults and children living below
the poverty line hovering at 25 percent and 32 percent respectively,
the statistics and indicators point to the need for aggressive action
to address the tremendous health care needs of the population in this
five county area.
Community Medical Centers proposes to address this health situation
with a pilot project to improve the health of farm workers and
residents of the rural communities who make up 41 percent of the
population of the region.
Community Medical Centers has proposed developing a collaborative
network that will include local healthcare providers, Federally
Qualified Health Centers, county health and human services agencies,
local hospitals, dentists, schools, churches and local communities. The
network will work to aggressively deliver both preventive and primary
health care to the people of the five county region. The new Regional
Health Center on the campus of the Regional Medical Center in downtown
Fresno will be the center for coordinating these activities. The new
Regional Health Center is just one component of a more comprehensive,
$210 million medical complex that will also include a new facility to
house Level I burn and trauma services, emergency services, in-patient
surgery, cardiac services and intensive care beds as well as a
University of California San Francisco (UCSF) Medical Education and
Research Center to house the teaching program. The Regional Health
Center will deliver primary and specialty care, offer easy access to
higher level care in an inpatient and outpatient setting, and access
the faculty and residents of the UCSF-Fresno Medical Education Program.
This $35 million project will:
--Improve access to the rural areas by partnering with existing
centers and local healthcare providers to provide access for
all patients and utilize and coordinate mobile health care
units to go into the areas that are under-served. In addition,
provide trained bilingual personnel to qualify people for
health care programs and educate them about preventive care.
--Focus on preventive care and high prevalence diseases by offering
asthma education and management programs; early diagnosis,
dietary and medical management of diabetes; teen pregnancy
prevention programs; prenatal care; screenings for cancer,
diabetes and high blood pressure; and dental and mental health
services.
--Result in a healthier community by providing primary care to a
significant portion of the population and reducing their
dependency on hospital emergency rooms for these services;
improve people's quality of life and health thereby reducing
hospital admissions for asthma, diabetes, hypertension and
complications associated with these diseases; reduce the number
of premature births.
--Realize significant savings in medical costs by focusing on the
health needs of the population and emphasizing prevention and
disease management as opposed to depending on hospitalization
for primary care. We predict a 20 percent decrease in emergency
room visits and hospitalization that would result in a
significant savings of $18 million per year.
The human statistics point to the need to address this situation
now before it progresses to a crisis. Community Medical Centers is
working with the County of Fresno to contribute $17.5 million of state
and local monies toward this pilot project. These monies, coupled with
an additional $17.5 million from the federal government, would provide
key funding support and ensure completion of this critical health care
initiative facing our community.
We have identified the HHS Health, Resources and Services
Administration (HRSA) Buildings and Facilities earmark in the fiscal
year 2002 appropriation bill for Labor/HHS/Education as a source of
funds. We understand that this program is specifically designated for
buildings and facilities, and we request your assistance in securing as
much of the needed $17.5 million as possible through this program
account for the Regional Health Center to be housed on the downtown
campus in Fresno. This past year, we were pleased to be the recipients
of $851,000 of Federal support for this project. The funding was
provided by the fiscal year 2001 Department of Health and Human
Services Appropriation Act (Public Law 106-554).
We appreciate your attention to this matter, and we hope that you
will favorably consider our request to improve healthcare delivery to
the Central San Joaquin Valley in California.
______
Prepared Statement of the Council of State and Territorial
Epidemiologists
FULL FUNDING FOR THE PUBLIC HEALTH THREATS AND EMERGENCIES ACT
The Public Health Threats and Emergencies Act (PHTEA) is landmark
legislation that was signed into law on November 13, 2000. The PHTEA
builds on three years of funding, provided by Congress, to prepare the
nation for bioterrorist attacks by strengthening the nation's public
health system at the local, state and federal level. The PHTEA was
introduced after a series of bipartisan Congressional forums, Committee
hearings and a GAO report all of which established that our public
health system is not prepared to detect or respond effectively to
significant public health threats, including major outbreaks of
infectious disease, pathogens resistant to antimicrobial agents, and
acts of bioterrorism. CSTE contributed to the development of the PHTEA
at every phase, and strongly supports funding the Act at the authorized
level of $534 million.
The PHTEA has four major components as follows: (1) $100 million
for building public health capacity with this amount expected to rise
in future years; (2) $40 million for antimicrobial resistance; (3) $215
million for Bioterrorism preparedness; and (4) $180 million for CDC's
facilities renovations. I will focus commentary on two components,
building public health capacity and bioterrorism preparedness.
Building Public Health Capacity by Strengthening Infrastructure.--
The Public Health Capacities provision of PHTEA has three main
sections. Section 319A requires the Secretary of HHS, by November,
2001, to establish reasonable capacities, including needed personnel or
workforce, that are appropriate for effective response to major public
health threats. These capacities would include, for instance, the
ability of a state or local health department to: recognize the
clinical signs and epidemiological signs of significant outbreaks of
infectious disease; identify the disease-causing pathogens rapidly;
organize and implement an effective medical response for those infected
and prevention measures for those in danger of exposure; and
communicate relevant information about the threat rapidly to other
health departments, the CDC and to the provider community. Section 319B
requires the Secretary, by November, 2001, to award grants to states to
perform an evaluation of the extent to which state and local health
departments can achieve the needed capacities. Finally, Section 319C
provides grants to state and local health departments to address the
identified gaps in their capacities--again with a focus on building
capacity to identify, detect, monitor and respond to threats to the
public health. Funds for filling gaps in capacities can be used to
train public health personnel; develop, enhance, coordinate or improve
participation in an electronic network for rapid disease information
dissemination; develop plans for responding to public health
emergencies coordinated with all levels of government; and enhance
laboratory capacity and facilities.
Part of public health capacity building reflects CSTE's efforts,
since 1994, to develop a comprehensive, state-based National Public
Health Surveillance System (NPHSS). Congress has begun to support
components of this system through the Health Alert Network (HAN) and
the National Electronic Disease Surveillance System (NEDSS). However,
there are other components that address the need for flexible,
coordinated, and efficient surveillance (or health tracking) systems
and that define the methods of surveillance in a changing health
environment. These issues are discussed more thoroughly in the NPHSS
section below.
Bioterrorism Preparedness.--For the past three years, Congress has
provided funding specifically to address the greatest public health
threat of all--bioterrorism. The PHTEA provides a more coherent
framework for addressing this very real threat, one that experts
believe will happen, it is just a matter of when. Some national
security officials believe the United States will experience a major
bioterrorist incident within the current decade.
The PHTEA ensures federal coordination of bioterrorism preparedness
by creating interdepartmental task forces and working groups. Grants
are made available to state and local health departments, but also to
hospitals, clinics and primary care facilities, for the following
purposes: (a) training of health care professionals and public health
personnel to recognize the symptoms and epidemiological characteristics
of exposure to a potential bioweapon; (b) rapid and accurate
identification of potential bioweapons; (c) coordinating medical care
for individuals exposed to bioweapons; (d) facilitating and
coordinating rapid communication of data generated from a bioterrorist
attack between national, state, and local health agencies and health
care providers.
BUILDING THE NATIONAL PUBLIC HEALTH SURVEILLANCE SYSTEM
Epidemiologists working in public health agencies are responsible
for monitoring trends in health and devising prevention programs that
enable the entire community to be healthy. The science of epidemiology
and surveillance, or health tracking, provide the basis for appropriate
public health practice. Public health assessment includes surveillance,
epidemiologic studies, program monitoring of diseases, risk factors for
disease, health hazards, and preventive actions. Surveillance enables
public health officials to:
--Recognize outbreaks and intervene to prevent additional cases;
--Identify priority health problems/needs so that resources can be
appropriately allocated;
--Identify high-risk communities and groups to effectively target
programs;
--Monitor the effectiveness of public health programs; and
--Identify issues that need further scientific study to devise
preventive strategies.
These core activities of public health agencies are critical to the
success of public health efforts, but have historically had no stable
funding source and are often the first to suffer in state funding
cutbacks. Funding restrictions in categorical federal programs have
also contributed to a fragmented approach to surveillance at the state
and local level. CSTE recommends that all federal funding for public
health programs recognize and adequately fund epidemiology, assessment
and surveillance as core required activities for public health
programs. States should also be given flexibility to combine and
integrate categorical funds for this purpose. This will help build the
National Public Health Surveillance System (NPHSS) which CSTE
conceptualized and has been advocating for among its various local,
state, and federal partners.
In addition to support for core public health surveillance, CSTE
supports the establishment of a national electronic public health
surveillance, or health tracking, system that encompasses development
of standards and criteria from which all programmatic surveillance
systems would be built. CSTE views this overarching electronic system
(NEDSS) as an important component of a National Public Health
Surveillance System. Several CDC programs have well-developed
surveillance systems that meet the needs of the program, but are not
easily linked to increase the body of knowledge of the public's health.
There is critical need for an over-arching model for integrated public
health surveillance that assumes collaboration and integration of data
collection efforts and use of surveillance resources across program and
Center lines both at the federal and state levels. More effective
integration of surveillance and health information systems could
increase the power of public health agencies to make effective use of
available information as economically as possible. In practical terms,
an integrated health tracking system allows the detection and
monitoring of infectious disease outbreaks and environmental hazards
that involve more than one local or state jurisdiction such as the
recent West Nile Fever outbreak.
Most importantly, a comprehensive, integrated, electronic
surveillance, or health tracking, system present in every state and
operational at the local, state and national level is the nation's best
defense against a serious bioterrorism threat. It is a critical
component of public health infrastructure that will significantly
strengthen core public health capacity.
For the past two years, Congress has provided specific resources to
begin implementing the National Electronic Disease Surveillance, or
Health Tracking, System (NEDSS). In fiscal year 2000, $20 million was
provided for this project at CDC and, in fiscal year 2001, $35 million,
but since $5 million of this was earmarked for specific projects only
$30 million was provided to CDC to continue building NEDSS nationally.
Currently, under the fiscal year 2000 extramural grants, the first
round to date, all 50 states have received some NEDSS funding with 42
states receiving Assessment and Planning grants averaging $86,000; 12
states receiving Element Development grants averaging $315,000 and two
states, New York and Oregon, receiving Charter Site grants averaging
$1,113,000 each. It is important to note that fully 35 states applied
for Element Development grants, which include features such as web
browser-based data entry, HL 7 messaging, and integrated data
repository, but in large part due to resource constraints, only 12
received funding. Similarly, CDC received 12 Charter Site applications,
but only had resources to fund two. Clearly more resources are needed
to help states build a national electronic health tracking system. CSTE
strongly supports $50 million in fiscal year 2002 for the NEDSS project
as a critical public health capacity building component as provided
within the Public Health Threats and Emergencies Act.
INCREASED SUPPORT FOR STATE CONDUCTED HIV CASE SURVEILLANCE, OR
TRACKING
HIV case surveillance, or tracking, is a critical defense against
the spread of AIDS, but currently depends on under-funded state and
local health departments where funding for on-going AIDS surveillance
(tracking) has been level or declining for several years. CDC estimates
200,000 250,000 persons are living with HIV (not AIDS) in non-HIV
reporting states. Several recent developments have intensified the need
for increased support for state and local health departments to conduct
appropriate HIV case surveillance: (1) in December, 1999, CDC issued
HIV case surveillance guidelines, but no additional funds were provided
to states despite the fact that HIV case surveillance costs twice as
much as AIDS surveillance; (2) the newly re-authorized Ryan White CARE
Act (Public Law 106-345) includes new provisions that that seek to
include HIV data in the formula that determines how many Federal
resources each state will receive; (3) the September, 2000 Institute of
Medicine report, ``No Time To Lose: Getting More from HIV Prevention,''
recommended that sentinel surveillance also be expanded to provide
additional information on HIV incidence. None of these important
recommendations and developments can be responded to without additional
resources for states.
For the 2000 and 2001 grant cycle for state cooperative agreements
with CDC to conduct HIV surveillance, states requested twice the amount
than they were awarded--a 40 percent gap in funding at a time when the
need for HIV case surveillance data is intensifying and its benefit as
a tool to target prevention efforts and reduce transmission of the
disease is clear. CSTE strongly supports a $45 million increase in
fiscal year 2002 to strengthen state and local health department HIV
surveillance (tracking) systems.
ADDRESSING IDENTIFIED STATE AND LOCAL ENVIRONMENTAL HEALTH CAPACITY
DEFICIENCIES
CSTE concurs with the Pew Environmental Health Commission's
findings and supports their recommendations to commit significant
national resources to enhance the National Public Health Surveillance
System (NPHSS) so that, in addition to the ongoing efforts to monitor
infectious diseases, the public health community can begin to track all
chronic diseases and conditions like asthma, birth defects, and various
forms of cancer. To advance the understanding of environmental disease,
the NPHSS needs to include an ability to investigate disease links to
environmental exposures. Much of the NPHSS will need to be based in
state and local health departments where the data is generated, but
allow aggregation for national assessment of progress toward the 2010
Healthy People goals. However, a comprehensive data system is not
enough. Sufficient public health expertise capacity must also be
present to interpret data, evaluate environmental health problems, and
advance solutions. Both data collection and timely local response are a
fundamental duty of state government, but experience has shown value-
added benefits from federal partnerships. The scope of environmental
public health activities is broad, ranging from assurance of the
quality and integrity of public food, water and waste disposal systems
to protecting the environment from manmade pollutants.
As a down payment on implementation of a nationwide health tracking
system which will include chronic disease and its link to environmental
exposures, CSTE urges Congress to provide an additional $20 million in
fiscal year 2002 to expand environmental health capabilities within
state health departments. Two agencies provide the bulk of the federal
support for state environmental public health: the Agency for Toxic
Substances and Disease Registry (ATSDR) and the National Center for
Environmental Health (NCEH); both are administered by CDC. The Pew
Commission has called for merging ATSDR and the NCEH under HHS at the
CDC. ATSDR provided nearly $9 million in fiscal year 2001 to 28 states
to assess environmental threats to communities. This program focus
needs additional funding to reach all states, and provide each state
with sufficient support.
The NCEH has been unable to provide core support for state
environmental public health, but does provide substantial technical and
laboratory assistance and categorical support to address issues such as
childhood lead poisoning and emerging environmental threats such as
asthma. CSTE urges the Subcommittee to increase support for CDC's
asthma program from its current funding level of $25 million to $50
million. In spite of significant advances in the diagnosis and
treatment of asthma, an improved understanding of the environmental
triggers of asthma attacks, the health burden of asthma in the United
States is increasing at epidemic proportions. Asthma affects more than
14 million Americans, of which five million are children. Over 5000
persons died from asthma in 1995, and asthma accounts for nearly
500,000 hospitalizations each year. The health care costs associated
with asthma exceeded six billion dollars in 1990, and is currently $11
billion. Experts predict that those costs could climb to more than $18
billion by the year 2020.
Asthma control and prevention requires a long term, multifaceted
approach that includes patient education, surveillance, and control
programs. These programs have not been available due to a lack of
resources at the state level. CDC's asthma program needs increased
funding.
RESTORING AND INCREASING FUNDING FOR THE PREVENTIVE HEALTH/HEALTH
SERVICES BLOCK GRANT
This program was cut $15 million in fiscal year 2000, a ten percent
reduction, and level funded in fiscal year 2001. State health officials
have indicated that $210 million is needed to enable them to respond to
identified health problems that gaps in discretionary program funding
prevent them from addressing, and unexpected health crises, such as
West Nile Virus, or an environmental hazard. The PHHS Block Grant
provides the only source of flexible funding for state health
departments to address health problems they have specifically targeted
under Healthy People 2010 goals, such as cardiovascular diseases and
injury, but do not have sufficient, or sufficiently flexible,
discretionary funds, to reach specified goals. In addition, up to five
percent of total Prevention Block Grant funding is used to support
basic public health activities including routine epidemiological
surveillance, or health tracking. It seems contradictory to the public
health community to support bioterrorism preparedness including
building epidemiological capacity in state and local health departments
and then threaten the net positive effect of this support by cutting
the block grant funding ten percent and then locking in the cut through
level funding.
SUPPORT FOR THE BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM
The Behavioral Risk Factor Surveillance System (BRFSS) is an
essential component of an overarching public health surveillance, or
tracking, system. It the only source of state level behavioral data,
but is used at every level of government to inform intervention
programs, policy decisions and budget direction for chronic and other
diseases. It is the source of data for 24 of the 73 chronic disease
indicators, six areas of the Healthy People 2010 leading health
indicators and serves as the core source of surveillance, or health
tracking, for multiple public health programs across the entire CDC.
The BRFSS is currently in its 17th year of operation and is the largest
continuous telephone survey in the world. It is flexible, timely and
allows for state-to-state and state-to-nation comparisons of data. The
BRFSS is able to address emerging health issues and fewer resources are
required to run BRFSS than is required to run in-person interviews. The
state-based telephone surveys are used to monitor health behaviors and
knowledge regarding tobacco use, physical inactivity, poor diet,
alcohol use, violence, risky sexual behaviors, and lack of preventive
services (i.e. screening and immunizations).
In spite of all the data that BRFSS provides and the role these
data play in the development of intervention programs and policy
decisions, CDC funding for BRFSS is discretionary and averages $62,000
per state. Although states support a majority of the costs of BRFSS
data collection, few are able to analyze and translate the data into
long-term disease prevention and control programs and policies due to a
lack of resources.
Current funding for BRFSS is $1.9 million. CSTE believes that BRFSS
should be a discrete line item in the CDC budget and that funding
should be doubled to $3.8 million in fiscal year 2002 to ensure
adequate funding for all states.
The Council of State and Territorial Epidemiologists appreciates
the opportunity to provide its fiscal year 2002 funding recommendations
to the Subcommittee. Our members look forward to working with the
Subcommittee to strengthen these areas of public health activity that
CSTE believes are so critical to enhancing and protecting the health of
the American public.
______
Prepared Statement of the Crohn's and Colitis Foundation of America
INTRODUCTION
Mr. Chairman, thank you for the opportunity to submit testimony on
behalf of the Crohn's & Colitis Foundation of America (CCFA). CCFA is a
non-profit, voluntary organization dedicated to finding the cure for
Crohn's disease and ulcerative colitis. Throughout its 34 year history,
CCFA has sponsored basic and clinical research of the highest quality.
The Foundation also offers a wide range of educational programs for
patients and healthcare professionals, and provides support services to
assist people in coping with these chronic intestinal diseases.
My name is Jean Kouris, I live in Berea, Ohio, a suburb of
Cleveland, and I am honored to represent the people of this country who
suffer from Crohn's disease and ulcerative colitis. These are serious
diseases that affect the gastrointestinal (GI) tract. Because they
behave similarly, Crohn's and colitis are known as inflammatory bowel
disease, or IBD. They can cause severe diarrhea, cramping abdominal
pain, fever, and rectal bleeding. Complications of IBD can include
arthritis, osteoporosis, anemia, liver disease, and colon cancer.
Crohn's and colitis are not fatal, but they can be devastating. We do
not know their cause, and we have no cure.
I am all too familiar with these diseases because my son Nathan is
one of the up to one million Americans who suffer from IBD. Nathan has
the dubious distinction of being among the youngest of children
diagnosed with Crohn's disease. And while his age at diagnosis is
unusual, the manifestation and course of the disease itself has not
been. His nine short years have been a study in endurance,
determination, the healing power of medicine and the healing power of
prayer.
When Nathan was about seven weeks old, I arrived to pick him up at
the end of a workday. The sitter told me that he had cried inconsolably
for most of the day, drawing his legs up as if he was in pain.
``There's something wrong with your baby,'' she said. The dutiful
first-time mother, I took him to see the pediatrician that evening.
Admittedly he was smiling and happy on my lap in her office, and her
explanation was that some babies just had a harder time separating from
their mothers when they went back to work.
Shortly thereafter, when he started passing bloody stools, I was
told this was fairly common, and to put him on a ``lactose-free'' diet.
By age six months he had been referred to a pediatric
gastroenterologist, who put him on medication and scheduled him for a
colonoscopy. When the biopsy results came back I was told that he had
something ``not usually seen in babies this age.''
Over the next few months Nathan's condition continued to
deteriorate, and I became increasingly disenchanted with this
particular physician. I first saw the words Crohn's disease when I
picked up Nathan's biopsy results to take to another doctor for a
second opinion. While waiting for the day of the appointment, Nathan,
who was now eleven months old and otherwise developing normally, became
so weak he could not stand up.
Three months later Nathan was put on ``total parenteral nutrition''
(TPN). TPN is a special liquid food mixture administered intravenously.
Around this time, I remember saying to the doctor ``I'm afraid he's
going to die,'' and she responded ``I'm not saying he won't, but right
now we're a million miles away from that.'' That was the right thing
for her to say to me as a mother, but I learned later that she had
cried privately, afraid too that he would not make it.
For the next nine months I kept a bag packed, at the ready to head
for the hospital if one of his twice-daily temperature readings was
elevated. That was a trip I made too many times to count, as Nathan
spent more than 90 days in the hospital during that time.
We have endured the comments of unknowing strangers, like the woman
who referred to him as ``a baby on a leash'' and one who scolded my
husband for ``overfeeding that poor child.'' The reality was that he
was seriously malnourished, but so bloated from the TPN and steroids
that his eyes had become mere slits.
I took pictures, as every baby book should have the full complement
of about a million and a half photos before age two. I took pictures of
Nathan in the hospital, Nathan with his favorite nurses, Nathan pulling
the TPN pack in a little red wagon, Nathan bare-chested with the
Broviac showing. I took pictures because he was a charming child,
always smiling and happy, a fun-loving baby who effervesced with a joy
for life.
Nathan is nine now. He has achieved a measure of medical stability,
and last summer, for the first time in his life, he actually went three
months between doctor visits! He plays baseball and football, and takes
piano and horseback riding lessons. He collects Poke-mon and does all
the things most nine-year-old kids do.
I know that throughout his life he will have good times and not so
good times. But Nathan has the spirit of a warrior and that's what
helps him get through the difficult days. I also know that a cure is
possible. I envision a world without Crohn's disease and ulcerative
colitis. I hope you do too.
If we are to find the cause of, and cure for IBD, we must
investigate all of the exciting possibilities that are being made known
to us. To take advantage of these opportunities, CCFA has developed
long-standing partnerships with NIH--specifically the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the
National Institute of Allergy and Infectious Diseases (NIAID)--and the
Centers for Disease Control and Prevention (CDC).
RECOMMENDATIONS FOR FISCAL YEAR 2002
NATIONAL INSTITUTES OF HEALTH
Mr Chairman, together with NIAID, NIDDK supports the majority of
IBD research at NIH. We were pleased that the Committee again last year
recognized CCFA's IBD research agenda, entitled ``Challenges in
Inflammatory Bowel Disease,'' in its report.
Although we have made significant progress in recent years in the
fight against Crohn's disease and ulcerative colitis, IBD remains among
the most challenging disorders affecting the digestive tract. IBD
patients and their families are pinning their hopes for a better life
on medical advancements made through NIH and CCFA sponsored research.
For this reason, CCFA supports the goal of the doubling the NIH budget
by fiscal year 2002 and joins with the Ad Hoc Group for Medical
Research Funding in recommending a 16.5 percent increase for NIDDK,
NIAID, and NIH overall in fiscal year 2002. Moreover, the CCFA
encourages the subcommittee to increase IBD research funding within
NIDDK and NIAID at the same rate as NIH overall.
Throughout its 30-year existence, CCFA has recognized the
importance of working closely with NIH. A primary principal of the
Foundation's research program is to provide investigators with seed
money to generate enough preliminary data to compete for NIH grants.
And indeed, at last count, 40 of 57 IBD researchers funded through
NIDDK and NIAID were former CCFA grant recipients.
Some of the most promising IBD research by the NIH has focused on
translating findings from studies conducted on animal models to humans
with IBD. These animal models have enabled researchers to form the
current hypothesis that Crohn's disease and ulcerative colitis are
caused by a malfunctioning immune system, wherein components of the
patient's immune system overreact to normal intestinal bacteria.
We know that people are susceptible to this malfunction because of
their genetic makeup but further research is necessary to determine
which bacteria are responsible, how these bacteria interact with the
intestine's immune system, and which immune system components are
involved.
Mr. Chairman, I am pleased to report that due in part to CCFA's
Basic Research Agenda and our partnerships with NIDDK and NIAID,
research findings are being translated with greater speed into new
therapies for IBD patients. According to an industry report, the total
sales of pharmacological therapies to treat IBD is expected to increase
to nearly $1 billion in 2008, and the most dramatic increase will be in
the sale of biologic therapies that target various proteins in the
immune system.
By working together we have begun to alleviate the intense pain
suffered by people with IBD, but there is a great deal more that needs
to be accomplished. Our progress thus far gives us tremendous hope for
the future, however, the study of new and promising research pathways
depends upon increased federal funding for IBD research at NIH.
Finally, CCFA is excited by NIDDK's recent announcement that Dr.
Stephen James, a leading IBD researcher, has joined the institute as
the deputy director of its Digestive Diseases and Nutrition Division.
We look forward to working with Dr. James in the search for improved
clinical therapies, and a cure for IBD.
CENTERS FOR DISEASE CONTROL AND PREVENTION
IBD Surveillance Program
Mr. Chairman, as I have mentioned previously, CCFA estimates that
``up to one million'' people in the United States suffer from IBD.
Unfortunately, we do not have an exact number: Due to the complicated
nature of these diseases, patients may remain undiagnosed or
misdiagnosed for several years. Given the recent advancements in
treatment for these diseases and the increased risk that IBD patients
have for developing colorectal cancer, CCFA is pleased that the
Committee again last year recommended that CDC initiate a nationwide
surveillance and epidemiological program with respect to IBD.
CCFA believes that generating improved epidemiological information
on the IBD population is essential if we are to provide our patient
community with the best possible care. We look forward to working with
CDC this year on a comprehensive IBD epidemiological program. We ask
that the subcommittee continue to support this important initiative in
fiscal year 2002.
Colorectal Cancer Prevention
Finally, Mr. Chairman, in addition to coping with either Crohn's
disease or ulcerative colitis, many IBD patients are at high risk for
developing colorectal cancer. As you may know, colorectal cancer is the
third most commonly diagnosed cancer for both men and women in the
United States and the second leading cause of cancer-related deaths.
Because people who have suffered from IBD for more than eight years are
susceptible to this disease, CCFA has a long history of actively
promoting the benefits of colorectal cancer screening.
Although colorectal cancer is almost entirely curable when detected
early, studies have shown a tremendous need to: (1) inform the public
about the availability and advisability of screening and (2) educate
healthcare providers about screening guidelines. CDC's National
Colorectal Cancer Roundtable is actively working to address these
challenges by partnering with organizations like CCFA to implement a
national public awareness campaign emphasizing the importance of
screening and early detection. CCFA encourages the subcommittee to
provide CDC with $15 million in fiscal year 2002 (an increase of $6
million over fiscal year 2001) for this vital campaign.
IBD RESEARCH AND SURVEILLANCE COORDINATING COMMITTEE
Mr. Chairman, because NIH and CDC are engaged in numerous research
and public health activities related to IBD, CCFA recommends that the
Department of Health and Human Services establish an Inflammatory Bowel
Disease Research and Surveillance Coordinating Committee to ensure that
the Federal government has a focused and coordinated plan for
addressing IBD.
CCFA recommends that the Coordinating Committee be comprised of
representatives from NIDDK, NIAID, the National Institute of Child
Health and Human Development, CDC and other Public Health Service
agencies as appropriate. The Committee would be charged with developing
and implementing a comprehensive IBD strategy in collaboration with the
IBD community. We ask that the subcommittee join us in supporting the
establishment of a Coordinating Committee in fiscal year 2002.
Mr. Chairman, thank you for the opportunity to present the views of
the Crohn's and Colitis Foundation of America.
______
Prepared Statement of the Cure for Lymphoma Foundation
INTRODUCTION
It is my pleasure to submit this statement regarding funding for
the National Institutes of Health (NIH) in fiscal year 2002 and
priorities for lymphoma research. I am a volunteer representing the
Cure For Lymphoma Foundation (CFL), a non-profit organization that
funds research on Hodgkin's disease and Non-Hodgkin's lymphoma (NHL);
provides educational materials and support services to individuals with
lymphoma and their families; and engages in advocacy activities to
advance a cure and improve the quality of care for those with lymphoma.
In November 1997, two weeks before my 38th birthday, I was
diagnosed with follicular non-Hodgkin's lymphoma, an indolent cancer
with a life-expectancy of seven to ten years. At that time, I was
advised that because this disease was incurable, the best treatment
strategy would be to ``watch and wait'' or defer treatment until I
experienced further progression of my disease. As the mother of two
young children, receiving this diagnosis and treatment recommendation
certainly sharpened my focus on the disease and the advances in the
treatment of lymphoma. During the next two years, I became involved in
the activities of CFL and became an amateur researcher monitoring each
and every advancement in lymphoma research and treatment. I felt one of
my strongest contributions to CFL could be participating in public
policy activities, attempting at every opportunity to create the very
best climate for lymphoma research.
By November of 1999, my disease had progressed to the point where
treatment became necessary and I participated in a clinical trial of a
vaccine for the treatment of lymphoma but achieved only a brief
remission. Currently, I am preparing to enroll in a second clinical
trial, this time hoping to secure a longer remission through a
combination therapy using monoclonal antibodies. It is my hope, in this
statement, to convey both the exciting opportunities for lymphoma
research and the sense of urgency that must be brought to this research
and its funding. Those of us living with lymphoma will accept no less.
INCIDENCE OF LYMPHOMA
The Director of the National Cancer Institute (NCI) proudly
reported this year that the incidence of most cancers is declining.
This achievement is to be applauded. However, the situation for
lymphoma is different. Since the 1970's, incidence rates for NHL have
increased dramatically, making it one of the fastest rising cancers in
the United States. The number of persons diagnosed with NHL has doubled
since the 1970's, and NHL is the second rising cancer in incidence and
death rates in the United States. The reasons for the increased
incidence of NHL are not understood. This is a matter that deserves
more attention, and CFL recommends a coordinated and aggressive
research enterprise directed toward strengthening our understanding of
the reasons for the increase in incidence of lymphoma.
LYMPHOMA RESEARCH ADVANCES AND OPPORTUNITIES
The nation's investment in basic research has deepened our
understanding of lymphoma and contributed to enhancements in treatment,
with many more therapeutic improvements expected. These advances
include:
--Use of genetic analysis techniques to identify subpopulations of
lymphoma patients who respond more favorably to chemotherapy.
NCI-sponsored researchers have developed a lymphochip, which
utilizes microarray technology and has allowed researchers to
identify two subtypes of B-cell lymphoma. This discovery has
significant implications, because further development and
commercialization of the lymphochip will allow physicians to
accurately diagnose patients and predict whether they may be
effectively treated with chemotherapy or not, depending on
their lymphoma subtype.
--Advances in immunology that have led to the development of a
monoclonal antibody for the treatment of indolent B-cell NHL
and may be the first of a group of therapies that use the
body's own immune system to fight cancer.
--Cancer vaccines that employ immunotherapy to rally the body's
defense against the diseases are currently being tested in
trials across the country.
--New therapies combining different modalities, such as immune
therapy and radiation, to fight the disease.
progress review group on leukemia, lymphoma, and myeloma
The NCI recently convened a meeting of extramural scientists,
physicians, and advocates in a Leukemia, Lymphoma, and Myeloma Progress
Review Group (LLM-PRG) that analyzed the current NCI portfolio of
research on blood-related cancers and opportunities and barriers to
research on these cancers. The report of the LLM-PRG is not yet
complete, but a preliminary draft summarizing the work of the advisory
panel captures the wealth of research opportunities that are available
to researchers on blood-related cancers and identifies strategies for
capitalizing on all those research avenues. We believe the unique
contribution of the LLM-PRG may be proposals for innovative cooperative
public-private sector research and development endeavors, and we
applaud the willingness of the group to consider aggressive research
strategies and structures.
Because advances in the treatment of blood-related cancers often
provide insights into the treatment of all other cancers, the LLM-PRG
report should be of particular importance not only to NCI but also to
the Congress.
fiscal year 2002 recommendations from cfl
CFL believes this is a critically important moment in lymphoma
research which must be maximized by an appropriate federal response.
CFL recommendations are listed below.
--Congress should sustain progress toward doubling the NIH budget in
the five-year period from fiscal year 1999 to fiscal year 2003.
We applaud the commitment of the Congress in providing
substantial increases in funding for NIH in fiscal year 1999,
2000, and 2001 and urge that you provide an increase of 16.5
percent in fiscal year 2002. A boost of this magnitude is
necessary to ensure that the five-year goal can be met.
--The Subcommittee should include language in its report that
requires NCI to respond to the recommendations of the LLM-PRG
when it appears before the Subcommittee to defend its fiscal
year 2003 budget. CFL believes the LLM-PRG report may make a
special contribution in identifying opportunities for public-
private sector cooperation, and NCI should be directed to pay
particular attention to these recommendations and its ability
to implement collaborative programs of this sort.
--The Subcommittee should also include language in its report that
requires NCI and the National Institute of Environmental Health
Sciences to coordinate their investigations of the possible
links between environmental exposures to toxins and the
development of lymphoma.
--The Centers for Disease Control and Prevention (CDC) should be
directed to enter into discussions with lymphoma researchers
regarding the collection of lymphoma incidence and survival
data through the CDC cancer registries program. In order to aid
the lymphoma research effort, CDC cancer registries should
collect lymphoma data by subtype.
______
Prepared Statement of the Digestive Disease National Coalition
Mr. Chairman, thank you for the opportunity to submit testimony
regarding fiscal year 2002 appropriations for the National Institutes
of Health and the Centers for Disease Control and Prevention. before
you today. I am Dr. Maurice Cerulli, a practicing gastroenterologist
and Chief of Gastroenterology at The Brooklyn Hospital Center and
president of the Digestive Disease National Coalition (DDNC). Founded
in 1978, the DDNC is a voluntary organization comprised of 25
professional and patient organizations concerned with the many disease
of the digestive tract. The Coalition has as its goal a desire to
improve the health of the millions of Americans suffering from both
acute and chronic digestive disorders.
Mr. Chairman, the social and economic impact of digestive disease
is enormous. Digestive disorders afflict approximately 62 million
Americans, resulting in 50 million visits to physicians, 10 million
hospitalization, 230 million days of restricted activity, and nearly
200, deaths annually. The total cost associated with digestive diseases
has been conservatively estimated at $60 billion a year.
On behalf of the DDNC, I would like to thank the subcommittee for
its past support of digestive disease research and prevention programs
at the NIH and CDC. With respect to the coming fiscal year, the DDNC
joins the Ad Hoc Group for Medical Research Funding in recommending a
16.5 percent increase for the National Institute of Diabetes and
Digestive and Kidney Disease (NIDDK), the National Institute of Allergy
and Infectious Diseases (NIAID) and the NIH overall. These increases
will keep on track, for the final 2 years, the initiative to double the
NIH budget over a 5 year period.
SPECIFIC RECOMMENDATIONS FOR FISCAL YEAR 2002
Inflammatory Bowel Disease.--Up to one million people in the United
States suffer from Crohn's disease and ulcerative colitis, collectively
known as inflammatory bowel disease (IBD). These are serious diseases
that affect the gastrointestinal tract causing bleeding, diarrhea,
abdominal pain and fever. Complications of IBD can include anemia,
ulcers of the skin, eye disease, colon cancer, liver disease,
arthritis, and osteoporosis. Crohn's disease and ulcerative colitis are
not usually fatal, but they can be devastating. We do not know the
cause, and we have no cure.
In recent years we have made significant progress in the fight
against IBD. In 1998, the FDA approved the first drug ever specifically
for Crohn's disease. The DDNC encourages the subcommittee to continue
its support of IBD research at NIDDK and NIAID at a level commensurate
with the overall increase for each institute.
Given the recent advancements in treatment for these diseases and
the increased risk that IBD patients have for developing colorectal
cancer, the DDNC believes that generating improved epidemiological
information on the IBD population is essential if we are to provide
patients with the best possible care. Therefore, the DDNC, and its
member organization the Crohn's and Colitis Foundation of America,
encourage the CDC to initiate a nationwide IBD surveillance and
epidemiological program in fiscal year 2002.
Endoscopic Research.--There continues to be tremendous potential
for the development of new diagnostic and therapeutic procedures for
gastrointestinal disorders. Without surgery, using endoscopes, we can
find bleeding ulcers and stop the bleeding; we can take out stones that
are blocking the bile duct; and we can cut out colon polyps to prevent
colorectal cancer. The Clinical Outcomes Research Initiative (CORI)
program is allowing us to link more than 50 centers around the country
to assess the outcomes of endoscopic therapies. The gastroenterology
community looks forward to working with the NIDDK to expand its
endoscopic research program and we encourage the subcommittee to
support this important effort.
Hepatitis C: a Looming Threat to Health.--It is estimated that 4
million Americans are infected with the Hepatitis C Virus (HCV).
Unfortunately the majority of infected individuals are unaware that
they have contracted the disease. In 1997, more than 10,000 people died
from hepatitis C and the CDC estimates that the death rate will triple
by 2010 unless there is additional research, education and effective
public healthy interventions. Moreover, liver failure from HCV now
accounts for more than half of all the liver transplants performed in
the United States and is the leading cause of liver cancer.
The DDNC joins with the liver disease community in recommending an
increase of $15 million in fiscal year 2002 for CDC's Hepatitis C
Prevention Strategy program. This new funding will expand the number of
states with CDC sponsored hepatitis C prevention coordinators from 16
to 50. In addition, we recommend an appropriation of $40 million (an
increase of $17 million over fiscal year 2001) for CDC's Prevention
Research Centers program.
Finally, Surgeon General David Satcher drafted a ``Dear Citizen''
letter last year warning American about the silent epidemic of HCV. The
letter provided important educational information on HCV as well as
action people can take to determine whether or not they are infected.
The DDNC encourages the subcommittee to work with the Surgeon General's
office in fiscal year 2002 to facilitate the distribution of this
important correspondence to all Americans.
Pancreatic Cancer.--Last year, an estimated 28,300 in the United
States were found to have pancreatic cancer and approximately 28, 200
died from the disease. Pancreatic cancer is the fourth leading cause of
cancer death in men and women. Only 2 out of 10 patients will live one
year after the cancer is found and only a very few will survive five
years. Although we do not know exactly what causes pancreatic cancer,
several risk factors linked to the disease have been identified:
--Age: Most people are over 60 years old when the cancer is found;
--Sex: Men have pancreatic cancer more often than women;
--Race: African Americans are more likely to develop pancreatic
cancer than are white or Asian Americans;
--Smoking
--Diet: Increased red meat and fats
--Diabetes
The National Cancer Institute has established a Pancreatic Cancer
Progress Review Group charged with developing a detailed research
agenda for the disease. The DDNC encourages the subcommittee to provide
an increase for pancreatic cancer research at a level commensurate with
the overall percentage increase for NCI.
Colorectal Cancer Prevention.--Colorectal cancer is the third most
commonly diagnosed cancer for both men and women in the United States
and the second leading cause of cancer-related deaths. Colorectal
cancer affects men and women equally. Although colorectal cancer is
preventable and curable when polyps are detected early, a General
Accounting Office report issued in March 2000 documented that less than
10 percent of Medicare beneficiaries have been screened for colorectal
cancer. This report revealed a tremendous need to: (1) inform the
public about the availability and advisability of screening; (2)
educate health care providers about colorectal cancer screening
guidelines.
CDC's National Colorectal Cancer Screening Awareness Program is
addressing these needs by partnering with organizations like the DDNC
and its coalition partners (AGA, ASGE, ACG, UOA) to develop an advocacy
agenda emphasizing the value of early detection. The digestive disease
community hopes that this relatively new program will do for colorectal
cancer screening rates what the CDC's Breast and Cervical Cancer
Screening Program has done for mammography and Pap smear screening
compliance.
The DDNC has seen first-hand the ambitious agenda that CDC and its
partners have developed to reduce the incidence of colorectal caner. We
are convinced that we can make a significant impact on screening rates
across the country if given adequate resources. Therefore, the
Coalition encourages the subcommittee to provide CDC with $15 million
in fiscal year 2002 (an increase of $6 million over last year) for this
important program.
Mr. Chairman, thanks to support provided by this subcommittee in
past years the NIDDK has been able to make important advances in the
understanding and treatment of digestive diseases and improve the
quality of life of many digestive disease patients.
One digestive disease that concerns us greatly is irritable bowel
syndrome (IBS) a disorder that affects an estimated 35 million
Americans. Many people with IBS suffer in silence, unable to speak
about the disease even to their family members. The medical community
has been slow in recognizing IBS as a legitimate disease and the burden
of illness associated with it. Patients often see several doctors
before they are given an accurate diagnosis.
Once a diagnosis of IBS is made, medical management is limited
because the medical community still does not understand the physiologic
mechanism of the disease. Living with IBS is a challenge. Trying to
learn how to manage the symptoms is not easy.
There is a loss of spontaneity when symptoms may intrude at any
time. Plans made often need to be changed. IBS is unpredictable. One
can wake up in the morning feeling fine and within a short time
encounter abdominal cramping to the point of being doubled over in pain
and unable to function.
The unpredictable bowel symptoms may make it next to impossible to
leave home. It is difficult to ease pain that may repeatedly occur
periodically throughout the day. One becomes reluctant to eat for fear
that just eating a meal will trigger symptoms all over again. IBS has a
broad and significant impact on a person's quality of life. It strikes
individuals from all walks of life and results in a significant toll of
human suffering and disability.
While there is much we don't understand about the causes and
treatment of IBS, we do know that IBS is a chronic complex of symptoms
affecting as many as one in five adults. In addition;
--It is reported more by women than men.
--It is the most common gastrointestinal diagnosis
amonggastroenterology practices in the United States.
--It is a leading cause of worker absenteeism in the United States.
--It costs the U.S. health care system an estimated $8 billion
annually.
Mr. Chairman, much more can still be done to address the needs of
the nearly 35 million Americans suffering from irritable bowel syndrome
and other functional gastrointestinal disorders. We understand the
challenging budgetary constraints that this subcommittee is operating
under, yet we hope you will carefully consider the tremendous benefits
to be gained by supporting a strong research and education program for
irritable bowel syndrome at NIH and CDC. Mr. Chairman, on behalf of the
millions of digestive disease sufferers, we appreciate your
consideration of the views of the Digestive Disease National Coalition.
______
Prepared Statement of the Doris Day Animal League
Mr. Chairman and members of the Subcommittee on Labor, Health and
Human Services, Education and Related Agencies Appropriations, thank
you for the opportunity to submit testimony on behalf of the 300,000
members and supporters of the Doris Day Animal League requesting
appropriations for the National Institute of Environmental Health
Sciences' (NIEHS) National Toxicology Program Interagency Center for
the Evaluation of Alternative Toxicological Test Methods (NICEATM) for
Interagency Coordinating Committee for the Validation of Alternative
Methods (ICCVAM) activities for fiscal year 2002. This entity, ICCVAM,
was permanently authorized in 2000.
FUNCTION OF ICCVAM
The ICCVAM performs an invaluable function for regulatory agencies,
industry, public health, and animal protection organizations by
assessing the validation of new, revised and alternative toxicological
test methods that have interagency application. After appropriate
independent peer review of the test method, the ICCVAM recommends the
test to the federal regulatory agencies that regulate the particular
endpoint the test measures. In turn, the federal agencies maintain
their authority to incorporate the validated test method as appropriate
for the agencies' regulatory mandates. This streamlined approach to
assessment of validation of new, revised and alternative test methods
has reduced the regulatory burden of individual agencies, provided a
``one-stop shop'' for industry, animal protection, public health and
environmental advocates for consideration of methods and set uniform
criteria for what constitutes a validated test method. In addition,
from the perspective of animal protection advocates, ICCVAM can serve
to appropriately assess test methods that can refine, reduce and
replace the use of animals in toxicological testing. This function will
provide credibility to the argument that scientifically validated
alternative test methods, which refine, reduce or replace animals,
should be expeditiously integrated into federal toxicological
regulations, requirements and recommendations.
HISTORY OF ICCVAM
The ICCVAM is currently composed of representatives from the
relevant federal regulatory and research agencies. It was created from
an initial mandate in the NIH Revitalization Act of 1993 for the NIEHS
to ``(a) establish criteria for the validation and regulatory
acceptance of alternative testing methods, and (b) recommend a process
through which scientifically validated alternative methods can be
accepted for regulatory use.'' In 1994, NIEHS established the ad hoc
ICCVAM to write a report that would recommend criteria and processes
for validation and regulatory acceptance of toxicological testing
methods that would be useful to federal agencies and the scientific
community. Through a series of public meetings, interested stakeholders
and agency representatives from all 14 regulatory and research
agencies, developed the NIH Publication No. 97-3981, ``Validation and
Regulatory Acceptance of Toxicological Test Methods.'' This report has
become the sound science guide for consideration of new, revised and
alternative test methods by the federal agencies and interested
stakeholders.
After publication of the report, the ad hoc ICCVAM moved to
standing status under the NIEHS' NICEATM. Representatives from federal
regulatory and research agencies and their programs have continued to
meet, with advice from the NICEATM's Advisory Committee and independent
peer review committees, to assess the validation of new, revised and
alternative toxicological methods. Since then, two methods have
undergone rigorous assessment and are deemed scientifically valid and
acceptable. The first method, Corrositex, is a replacement for animal-
based dermal corrosivity tests for some chemicals. The second, the
Local Lymph Node Assay, is a reduction and refinement of an animal test
for the skin irritation endpoint. The open public comment process,
input by interested stakeholders and the continued commitment by the
federal agencies has led to ICCVAM's success. It has resulted in a more
coordinated review process for rigorous scientific assessment of the
validation of new, revised and alternative test methods.
REQUEST FOR APPROPRIATIONS
On December 19, 2000, the ``ICCVAM Authorization Act'' which makes
the entity a permanent standing committee, was signed into Public Law
No. 106-545. For the past few years, the NIEHS has provided
approximately $1 million per fiscal year to the NICEATM for ICCVAM's
activities. In order to ensure that federal regulatory agencies and
their stakeholders benefit from the work of the ICCVAM, it is important
to fund it at an appropriate level. I respectfully urge the
Subcommittee to support an appropriation for the NIEHS's NICEATM for
ICCVAM's activities at $3 million for fiscal year 2002. This
appropriation request includes all FTEs, funding for independent peer
review assessment of test methods and meetings of the ICCVAM and other
activities as deemed appropriate by the Director of the NIEHS.
REQUEST FOR COMMITTEE REPORT LANGUAGE
I also respectfully request the Subcommittee consider the following
report language for the Senate Labor, Health and Human Services,
Education and Related Agencies Appropriations bill:
``The Committee supports the assessment of scientific validation of
new, revised and alternative toxicological test methods by the ICCVAM.
The Committee directs the regulatory and research agencies, including
the National Institute of Environmental Health Sciences, Food and Drug
Administration and Environmental Protection Agency, to use the
expertise and credibility of the ICCVAM for these assessments to
streamline their individual consideration of new, revised and
alternative toxicological test methods. The Committee also urges the
federal regulatory and research agencies to incorporate scientifically
validated new, revised and alternative test methods into their
regulations, requirements and recommendations in an expeditious
manner.''
Thank you for the opportunity to submit this request on behalf of
the Doris Day Animal League.
______
Prepared Statement of the Dystonia Medical Research Foundation
Chairman Specter, thank you for the opportunity to describe for the
Subcommittee how dystonia has affected our lives and our
recommendations for fiscal year 2002 federal funding of dystonia
research.
My name is Rosalie Lewis, president of the Dystonia Medical
Research Foundation. Three of my four sons have dystonia, and my fourth
son is a carrier of the DYT1 gene which is responsible for generalized
dystonia that begins in childhood. As there is no cure for dystonia,
and only in the past thirty years has research given way to treatments
other than brain surgery, my sons have had some benefit from oral
medication and botulinum toxic injections. Although we are fortunate to
have these treatments available, the various drugs have significant
cognitive side-effects.
Dystonia is a neurological movement disorder characterized by
involuntary muscle contractions and postures. There are several
different types of dystonia, including: focal dystonias, affecting
specific parts of the body, such as the arms, legs, neck, jaw, eyes,
vocal cords; and generalized dystonia, affecting many parts of the body
at the same time. Some forms of dystonia are genetic and others are
caused by injury or illness. Dystonia does not affect a person's
consciousness or intellect, but is a chronic and progressive physical
disorder for which, at this time, there is no cure. We believe that
some form of dystonia affects about 300,000 people in North America.
In the past few decades, dystonia researchers have made several
exciting scientific advancements and have been able to rapidly turn
laboratory and clinical research into diagnostic examinations and
treatment procedures, directly benefitting those affected. Genetics, in
particular, is opening up new understanding into the cause and
pathophysiology of the disorder. Thus far, 12 dystonia related genes
have been identified. In 1997, the DYT1 gene for childhood onset
dystonia was identified, and we now have a genetic test available for
this particular type of dystonia.
RESEARCH, AWARENESS, AND SUPPORT
It is an exciting time to be involved in dystonia research and
awareness. Researchers are becoming more interested in movement
disorders and dystonia at the National Institutes of Health (NIH), and
research is yielding promising clues for better understanding and
management of this disorder.
One way the Dystonia Foundation has advocated for more research on
dystonia, is by funding ``seed'' grants to researchers. Thus far, the
Dystonia Foundation has funded 338 grants, and 3 fellowships, totaling
more than $17 million. Due to our advocacy there is a growing number of
talented researchers dedicated to understanding the biochemistry of
dystonia, genetic causes, new therapeutics and the ramifications of an
epidemiology study.
Another primary goal of the Dystonia Foundation is education of
both lay and medical audiences. Every year the Foundation conducts
several medical workshops and regional symposiums to present, discuss,
and disseminate comprehensive medical and research data on dystonia. In
January, 2001 NINDS co-sponsored a genetics and animal models meeting,
designed to involve not only prominent researchers but inviting junior
investigators to participate in the discussions. Additionally, in
October 1996, the NIH was one of our co-sponsors for an international
medical symposium, which featured 60 papers on dystonia and 125
representatives from 24 countries. Our next major international
symposium is scheduled for September, where again we anticipate NINDS
to co-sponsor the meeting.
Since 1995, over 3,000 educational medical videos have been
distributed to hospitals, medical and nursing schools, and at medical
conventions. Now, we have a children's video to increase public
awareness of this devastating disorder. Media awareness is conducted
throughout the year, and especially during Dystonia Awareness Week,
observed nationwide from October 14 through 20, 2001.
The Dystonia Foundation has over 200 chapters, support groups, and
area contacts across North America. In addition, there are 15
international chairpersons whose mission is to increase awareness,
children's advocacy, development, extension, the Internet, leadership,
medical education, an on-line news group, and symposiums. Furthermore,
patient symposiums are held regionally to provide the latest
information to dystonia patients and others interested in the disorder.
Last year we held over eight regional symposiums reaching approximately
2,000 affected families.
DYSTONIA AND THE NATIONAL INSTITUTES OF HEALTH
The Dystonia Medical Research Foundation recommends an increase to
$23.7 billion or 16.5 percent for NIH overall, and a 16.5 percent
increase for NINDS and NIDCD or $1.37 billion and $350 million
respectively. This increase reflects a request to double the NIH budget
in five years. However, we request that this increase for NIH does not
come at the expense of other Public Health Service agencies.
Dystonia is the third most common movement disorder after
Parkinson's and tremor, and effects six times more people than better
known disorders such as Huntington's, muscular dystrophy and ALS or Lou
Gehrig's Disease. We ask that NINDS fund dystonia-specific extramural
research at the same level that it supports research for other
neurological movement disorders.
We urge the Subcommittee to recommend that NINDS provide the
necessary funding for extramural research and a large scale dystonia
epidemiological study and increase its efforts to educate the public
and medical community about dystonia though cosponsorship of workshops
and seminars. We also encourage the Subcommittee to support NIDCD in
its efforts to revamp its strategic planning process by implementing a
Strategic Planning Group which will help NIDCD as they: consider
applications for high program priority; develop program announcements
and requests for applications; and develop new research areas in the
Intramural Research Program.
The ultimate goal of the Dystonia Foundation is a cure for
dystonia. Until that goal is realized, we are hungry for any knowledge
about the nature of dystonia and for more effective treatments with
fewer side-effects. We have amassed many exceptional and diligent
researchers, committed to our goal, and our top priority is funding
their very important research. But the Foundation cannot do it alone.
We need federal support through NIH, NINDS, and NIDCD to continue to
fund good research and eliminate this debilitating disease.
I would like to introduce Mr. Peter Cohen.
Thank you Rosalie, my name is Peter Cohen and I have dystonia.
Because of this neurological disorder, I have difficulty walking,
standing, writing, and driving a car, just to mention a few daily
activities I can't take for granted. Dystonia affected me first when I
was a teenager, I developed muscle spasm and tremors. By my late
twenties it became increasingly difficult to walk, my neck would turn
involuntarily, and the tremors had spread to much of my body.
As these physical changes worsened over time, dystonia began to
affect my professional and personal life. It became virtually
impossible for me to read, write, type or sit in a comfortable working
position, and I was forced to give up a successful career as an
attorney. Furthermore, it became increasingly difficult to be in social
situations. I felt physically and emotionally awkward because of the
challenges presented by dystonia. I started isolating myself because I
was ashamed of my appearance.
For the past couple of years I have tried to move beyond this
shame. I look forward to a day when there is a cure for this
debilitating disorder and I can fully participate in life.
Thank you Peter, Chairman Specter, we ask that you aggressively
support medical research, specifically for movement disorders and brain
research. By doing so, you are doing a tremendous service for myself
and my family, for Peter, and to the hundreds of thousands of people
and families affected by dystonia.
Thank you very much.
THE DYSTONIA MEDICAL RESEARCH FOUNDATION
The Dystonia Medical Research Foundation was founded 25 years ago
and has been a membership-driven organization since 1993. Since its
inception, the goals of the Foundation have remained the same: to
advance research for more effective treatments of dystonia and
ultimately a cure; to promote awareness and education; and support the
needs and well being of affected individuals and their families.
______
Prepared Statement of Easter Seals
Easter Seals is a national nonprofit service organization dedicated
to helping children and adults with disabilities achieve independence.
Collectively, Easter Seals assists more than one million people
annually through a national network of 105 affiliates. Easter Seals
appreciates the opportunity to report on the success of ``Early
Childhood Development Project for the Mississippi Delta Region (Delta
Project),'' and to recommend that $1.6 million be allocated in fiscal
2002 to conduct the project's fifth and final year.
To date, the Delta Project has provided essential services to 7,000
children with disabilities who would otherwise have gone without needed
evaluation and therapy services. Hundreds of Delta families have
received counseling, training, and support that helps parents
understand and promote their child's development. Delta Project staff
have provided technical assistance and training to hundreds of child
care workers, early intervention and health department professionals,
teachers, therapists, doctors, and others to enhance competencies for
better helping children with disabilities develop and learn. The Delta
Project is committed to building lasting local capacity for improved
service to children with disabilities and associated developmental and
educational results. Delta project activities are conducted
collaboratively with state and local health and education agencies and
other providers, and do not duplicate or supplant available services.
DELTA PROJECT RATIONALE AND DESIGN
Children with disabilities in the Mississippi Delta are not
receiving the appropriate early intervention and education services
that they need to maximize development and learning. Proportionately
lower family incomes, fewer public resources, shortages of pediatric
personnel and specialized services, and inadequate support systems for
families and staff are among the factors contributing to this
situation. Geographic isolation, caused by wide dispersal of residents
and community resources, poor roads, and lack of transportation, make
it difficult for families to access services locally and out-of-region,
and impede the ability of service providers to be available as needed.
As a result, increased attention and supports are needed to promote
more effective implementation of the Individuals with Disabilities
Education Act (IDEA) in Delta communities, as well as other rural areas
across the country.
The Delta Project is demonstrating strategies for building local
capacity to improve early intervention and education services and
enhance developmental and educational results for children with
disabilities in the Delta regions of Arkansas, Louisiana and
Mississippi. It offers a nationally-significant, replicable model for
overcoming chronic gaps in local services and addressing parental and
personnel preparation needs.
The Delta Project was officially launched in October 1998, with
significant project activities appearing in targeted Delta communities
in Arkansas, Louisiana and Mississippi in January 1999. Project
implementation is occurring in phases, reflecting annual appropriations
and U.S. Department of Education funding cycles. To date, Congress has
approved a total of $3.725 million for this five-year initiative. A
final appropriation of $1.6 million is recommended for fiscal 2002, to
enable Easter Seals to provide full-scale services, training, and
technical assistance in 45 Delta counties and parishes, and to report
overall project findings. No further requests to earmark Education
Department funds for this initiative will be made after 2002. To the
extent necessary, Easter Seals will sustain needed capacity-building
efforts using existing public and private funds.
The Delta Project is bringing needed expertise, technical
assistance, and support to local families, educators and service
providers, and community decision-makers that are currently lacking in
the Delta. Major goals of the Delta Project are:
--Improve child find activities.
--Improve the quality and availability of appropriate early
intervention and childhood development services for Delta
region children with disabilities.
--Increase parent information and skills to better promote child
development and learning.
--Increase the capacity of local educators and service providers to
better serve children with disabilities and their families.
--Increase the ability of community decision-makers to create
solutions to improve access to appropriate services for
children with disabilities.
The Delta Project achieves these goals through collaboration with
state and local health and education personnel, parents of children
with disabilities, and local decision-makers, by:
--providing training and technical assistance to teachers, other
education personnel, public health practitioners, child care
workers and others to elevate their skills and ease in
assisting children with disabilities and families;
--providing training and support to families with children with
disabilities to promote increased understanding of child
development and parent-child activities that advance child
development and learning;
--facilitating collaboration and problem-solving among local
agencies, community resources and decision-makers to improve
services and results for children with disabilities; and,
--offering short-term, otherwise unavailable evaluation and essential
services for children with disabilities.
DELTA PROJECT STATUS & RECENT ACTIVITIES
Although Easter Seals is seeking final year funding for the Delta
Project in fiscal 2002, the project is programmatically at its mid-
point in terms of implementation and capacity building effect. A
summary of significant accomplishments and selected activities during
the past six months (October 1, 2000 to March 31, 2001) follows.
Over the past two and one-half years, the Delta Project has proven
an effective catalyst for necessary change in Delta communities.
Significant accomplishments include:
--Dramatically enhanced child find efforts through capacity building
with Head Start agencies, child care providers, physicians,
local health departments and other service agencies. For
example, in East Carroll Parish, Louisiana, these efforts
resulted in the identification and referral of ten children
with developmental delays for services. This may not seem
noteworthy until contrasted with previous years during which no
children with developmental needs were found, despite the birth
of hundreds of children annually in an at-risk environment of
crushing poverty, teen pregnancy, and inadequate pre-natal
care. In Bolivar County, Mississippi, project staff
collaborated with Head Start to screen 282 preschool children
for developmental delay and other needs, of whom 49 were
referred for additional testing.
--Substantial increase in access to early intervention services in
the Delta because of developmental screenings, evaluations, and
short-term therapy services provided by Project staff. A total
of 438 children received short-term therapy services from
project staff across the three-state region. It is important to
note that these services meet not only the immediate needs of
specific children, but also address personnel and parent needs
as well. In Arkansas, for example, the majority of children
were referred by school personnel triggering direct service to
children, accompanied by consultation on classroom programming,
behavioral issues, and augmentative communications needs. In
many instances, parents were included in these consultations.
--Increased competency of nearly 400 Delta health and education
professionals to better understand and serve children with
disabilities through participation in 15 project training
sessions that addressed topics of greatest concern. For
example, two tri-state training conferences were held in Little
Rock; ``Communication Development with Autistic Spectrum
Disorder,'' held in October 2000 and ``Managing Children's
Behavior in a Positive, Developmentally Appropriate Way'' in
February 2001. A workshop was held in Greenville, Mississippi
in late march 2001 entitled ``Sensory Processing: From
Definition to Intervention,'' which was attended by 53
professionals and paraprofessionals from the three-state Delta
region.
--Higher level of knowledge and skills development among Delta
parents due to project training and support. For example, three
parent workshops on Early Brain Development were conducted in
Morehouse and Richland Parishes, Louisiana, that helped 47
parents understand early brain development and its relevance to
their child's abilities and needs. In Arkansas, project staff
helped hundreds of families, including 40 parents who received
individualized consultations on developmental milestones, home
activities to enhance development, positioning techniques,
feeding strategies, and effective use of assistive technology.
--Greatly increased awareness of child development needs and services
in the Delta through distribution of materials, participation
in agency initiatives, presentations, and use of the media. For
example, the project developed and distributed 2,881 copies of
a basic child development letter titled ``Is Your Child on
Track,'' which helps parents, personnel, and others to better
understand child development milestones, recognize potential
delays, and to facilitate evaluations, as appropriate. Delta
project staff regularly contribute to health and education
agency decision-making, such as First Connections in Arkansas,
Children's Coalition in Louisiana, and First Steps in
Mississippi, and Interagency Coordinating Committees in all
three states. Community contacts with faith groups, community
groups and the media are a regular part of Delta Project
outreach.
The Delta Project is fully operational in 45 counties and parishes,
representing the entire area originally targeted based on need, as
follows:
--Arkansas.--Arkansas, Ashley, Bradley, Chicot, Crittenden, Cross,
Desha, Drew, Lee, Lincoln, Mississippi, Monroe, Phillips,
Poinsett, and St. Francis.
--Louisiana.--Avoyelles, Catahoula, Concordia, East Carroll, East
Feliciana, Franklin, Livingston, Point Coupee, Madison, Monroe,
Richland, St. Helena, Tensas, West Carroll, and West Feliciana.
--Mississippi.--Adams, Bolivar, Coahoma, Claborne, De Soto,
Humphreys, Issaquena, Jefferson, Leflore, Sunflower, Sharkey,
Tunica, Warren, Washington, and Wilkerson.
Note.--Project staff are currently conducting a comprehensive needs
assessment in parishes and counties listed in italics. Planning and
coordination services will be available in these targeted areas this
fiscal year, and full project services will be implemented beginning
October 2001.
Project offices are located in Little Rock, AR, Monroe, LA,
Covington, LA, and Greenville, MS. Easter Seals Arkansas based in
Little Rock serves as project headquarters, coordinating project
services in Arkansas and overseeing region-wide training, technical
assistance, evaluation, and reporting activities.
Highlights for the period, by state, characterize the Delta
Project's fundamental and lasting contribution to addressing chronic
needs at the local and national levels.
In Arkansas, selected accomplishments during the past six months
include:
--Educated 30 mothers attending a Lee County WIC (Women, Infants and
Children) Clinic about developmental milestones and potential
indications of developmental delay, and guidance on accessing
needed services.
--Assessed 81 children for developmental delay, with one-third being
referred to the early intervention program.
--Initiated 171 contacts with social, health, educational, parenting,
and therapy providers in the Delta to enhance child find
efforts; 27 contacts were with physicians and 85 visits were
made to Head Start and community child care centers.
--Participated in health fairs in Monroe and Desha counties and
provided information to about 375 people on child development
and early intervention.
--Surveyed 772 therapists in the three-state Delta region regarding
practices and attitudes on delivering school-based therapy
services in the classroom (inclusionary) versus on a ``pull-out
basis. Therapists generally favored services outside of the
classroom, while administrators and teachers supported an
inclusionary approach.
In Louisiana, selected accomplishments during the past six months
include:
--Boosted child find results in chronically underserved areas, with
40 percent of the children assessed by project staff referred
to the early intervention program.
--Met with LSU Shreveport medical staff address concerns that
children referred to ChildNet for early intervention services
after medical treatment were not entering the system or
accessing needed services. Project staff worked out a solution,
whereby project staff will facilitate the referral process
between LSU and ChildNet and support ChildNet in reducing
service delays.
--Collaborated with Child Search Coordinators to identify and address
barriers to raising awareness among parents regarding the
benefits of early intervention.
In Mississippi, selected accomplishments during the past six months
include:
--Established a collaborative relationship with the Delta Area Health
Education Centers and Delta Medical Society to schedule
presentations by project staff and disseminate project
information.
--Moved project office from Jackson to Greenville to better access
and support local early intervention and education systems
serving children with disabilities.
--Aided development of a proposal by Part C leadership to increase
Medicaid payment for early intervention services that has been
submitted to the governor for review.
--Scheduled regional training conferences for therapists, teachers,
and parents to be held in Greenville, MS in spring 2001 on
sensory processing, inclusion or intrusion, and therapeutic
interventions.
Detailed information on Delta Project activities and findings are
described in a mid-year report to the U.S. Department of Education,
submitted May 2001.
Delta Project accomplishments and outcomes are evaluated by the
University of Alabama's Civitan International Research Center, based in
Birmingham, Alabama. The Civitan International Research Center is a
University-Affiliate Program with research and evaluation expertise in
early childhood development and programs serving children with
disabilities in the Mississippi Delta Region. Civitan conducts an
independent evaluation of the Delta Project, including site visits,
throughout the year. During the past six months, evaluation staff
conducted project site visits in Arkansas on January 30-31, 2001; in
Mississippi on February 22-23, 2001; and Louisiana on March 8-9, 2001.
Civitan reports its findings to the U.S. Department of Education on a
semi-annual and annual basis. Easter Seals is pleased that evaluation
findings to date are favorable.
Easter Seals greatly appreciates the Subcommittee's strong support
for initiating and continuing the ``Early Childhood Development Project
for the Mississippi Delta Region.'' The Delta Project is beginning to
have a dramatic, positive, and lasting impact in Arkansas, Louisiana,
and Mississippi. It is generating valuable lessons and techniques for
use in underserved areas throughout the country. Investment of $1.6
million in fiscal 2002 will support final year operations in the three-
state region, evaluation and reporting, and the dissemination of
findings and recommendations. Proposed statutory and report language
for fiscal 2002 is attached for your information and use. Thank you for
supporting the Delta Project.
early childhood development project for the mississippi delta region
The following statutory and report language is proposed for use in
the fiscal 2002 Appropriations Bill for Labor-HHS-Education for the
U.S. Department of Education, Office of Special Education and
Rehabilitative Services, Special Education programs IDEA Research and
Innovation.
FISCAL 2002 APPROPRIATIONS STATUTORY LANGUAGE
``Of the funds provided, $1,600,000 shall be available for Easter
Seals Arkansas ``Early Childhood Development Project for the
Mississippi Delta Region.''
REPORT LANGUAGE TO ACCOMPANY FISCAL 2002 APPROPRIATIONS BILL
``The Committee continues to be concerned about unmet needs among
children with disabilities in rural areas, particularly the Mississippi
River Delta, and the lack of adequate support in these areas for
parents, school personnel, child care staff, and health providers to
overcome chronic barriers to effective local service delivery. The bill
addresses these concerns by providing $1,600,000 to continue the Early
Childhood Development Project for the Mississippi River Delta Region to
be carried out by Easter Seals Arkansas in Arkansas, Louisiana and
Mississippi. The Committee recognizes that this multi-year project
provides unduplicated early intervention and early childhood services
to children with disabilities ages birth through twelve years, assists
parents, and builds lasting local capacity to better provide and
coordinate such services to maximize developmental and educational
results. Valuable solutions generated by this project will be available
for replication across rural America.''
DELTA PROJECT--SUMMARY OF SERVICES
[October 1, 2000-March 31, 2001]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arkansas Louisiana Mississippi
------------------------------------------------------------------------------------ Total Total Number
Number of Number of Number of Children of Visits
Children Number of Children Number of Children Number of Seen For For Period
Seen Visits Seen Visits Seen Visits Period
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluations............................. 42 52 15 15 11 31 68 92
Consultations........................... 29 29 3 3 ............ ............ 32 32
Screenings.............................. 32 1 ............ ............ 282 ............ 314 1
Therapy:
OT.................................. ............ ............ 13 137 ............ ............ 13 137
PT.................................. ............ ............ ............ ............ 1 4 1 ............
SLP................................. ............ ............ 20 203 ............ ............ 20 203
Other............................... ............ ............ 4 54 ............ ............ 4 54
---------------------------------------------------------------------------------------------------------------
Total............................. 103 82 41 412 294 35 438 529
---------------------------------------------------------------------------------------------------------------
Number of Number of Number of Number of Number of Number of Total Total
Individuals Trainings Individuals Trainings Individuals Trainings Trained Trainings
Trained Conducted Trained Conducted Seen Conducted Conducted
---------------------------------------------------------------------------------------------------------------
Inservice............................... 205 9 126 5 53 1 384 15
Parent Training/Consultations........... 38 42 114 114 15 35 167 191
---------------------------------------------------------------------------------------------------------------
Total............................. 243 51 240 119 68 36 551 206
--------------------------------------------------------------------------------------------------------------------------------------------------------
______
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. Founded in 1968, its national office is based in
Landover, Maryland. The national office and its network of more than 60
affiliates across the country provide many direct services to
individuals and families, including: community education; employment
assistance; recreation; professional education conferences; assisted
living; and case management and counseling.
The Epilepsy Foundation supports 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. At least 2.3 million people currently have
epilepsy; the number of people affected by epilepsy, family members,
teachers, care givers, employers is an exponentially far larger number.
A recent CDC study in Texas found 1.8 percent of adults had been
diagnosed with epilepsy or seizures. Approximately 181,000 new cases of
epilepsy occur each year; 10 percent of all Americans will experience
seizures in their lifetimes.
MEDICAL RESEARCH ADVANCEMENT
The Epilepsy Foundation actively supports the efforts of Congress
to double funding for the National Institutes of Health. We are pleased
that NIH maintains strong bi-partisan support and has enjoyed
significant increases in funding. These investments in our nation's
health are paying dividends. In the last decade considerable progress
has been made in identifying genes associated with epilepsy and in
developing medications, devices and surgical treatments.
Almost a year ago, participants in a historic scientific conference
predicted that prevention and a cure for epilepsy are only a generation
away. Now the scientific community is working on next steps and ways to
measure progress toward those goals. The conference, ``Curing Epilepsy:
Focus on the Future'', was sponsored by the National Institute for
Neurological Disorders and Stroke (NINDS), which is the primary federal
sponsor of epilepsy medical research. The Epilepsy Foundation was one
of the co-sponsors. NINDS, together with scientific experts have
developed a set of benchmarks and priorities to guide future research.
Specifically, the conference and the benchmarks look at how
epilepsy begins, ways of identifying people at risk and how to develop
treatments that will prevent epilepsy in those people as well as
continuing the search for new therapies, free of side effects, to
prevent seizures. Clearly there are significant opportunities for
advancements in epilepsy research.
THE IMPACT OF SEIZURES
Despite this progress and hope for the future, epilepsy remains a
chronic condition that usually requires a lifetime of medical
treatment. 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.
A recent cost study estimates that the cost of epilepsy, focussed
on its most narrow measures, the direct medical costs, and the indirect
costs as identified by the impact on earning and home production, is
$12.5 billion annually.
The consequences of seizures continue to be severe and life
altering, even among people with well-controlled seizures. Their impact
spans employability, income levels, education, marriage, fertility,
life expectancy and life style. The Texas study showed high levels of
pain, anxiety, poor health, depression, and fatigue among adults living
in the community, to the degree that their quality of life was
negatively affected about 40 percent of the time.
Twenty five percent of all people with epilepsy are unemployed;
among those who are partially or poorly controlled, unemployment
approaches 50 percent. Marriage and fertility rates are reduced in
people with epilepsy, there is an increased risk of brain damage and
increased mortality and stigma remains a fact of life for too many
people fueling discrimination and isolation from the mainstream of
life.
Children with epilepsy are at special risk of learning
difficulties. Studies have documented deficits in language, visual-
spatial function, problem solving, and adaptive behaviors, even in the
absence of co-morbidity. Children with epilepsy have unique
difficulties when compared to those with other chronic illnesses such
as asthma and diabetes; achievement scores are lower, there are
problems with self-concept, depression, and behavior. These studies
demonstrate the critical importance of early recognition and treatment,
as well as the often unanticipated consequences that a diagnosis of
epilepsy can have.
RESEARCH AND PUBLIC HEALTH RECOMMENDATIONS
The Epilepsy Foundation supports the doubling of the NIH budget. We
expect that the NINDS will update Congress and the epilepsy community
on the progress being made to implement the recommendations from the
conference entitled ``Curing Epilepsy: Focus on the Future.''
Continuing to invest in basic and clinical research is crucial to
meeting our goal of preventing and curing epilepsy. However much more
needs to be done to address the impact of epilepsy and to improve the
quality of life of those living with the disorder. 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.
In 1993 Congress recognized this need and directed the Centers for
Disease Control and Prevention (CDC) to develop an epilepsy program
within the National Center for Chronic Disease Prevention and Health
Promotion. As a result, the CDC initiated a number of activities
including a public health campaign geared toward teen awareness and
education, a project with the Agency for Healthcare Research and
Quality to develop provider education materials and surveillance and
prevention research activities to better analyze trends in access to
care, levels of care and other demographic variables.
In 2000, Congress expanded the program by passing the Children's
Health Act of 2000. The goals for this program include progress in
research, epidemeology and surveillance, early detection, improved
treatment, public education and expansion of interventions to support
people with epilepsy and their families in their communities. The
Children's Health Act of 2000 also authorized a new program within the
Health Resources and Services Administration. HRSA is directed to
create grants to improve access to health and other services regarding
seizures; and to gear projects toward encouraging early detection and
treatment for those living in medically underserved areas.
This agenda is much larger than current resources for the program.
In fiscal year 2001, Congress appropriated $4 million for the CDC
epilepsy program. Additional resources will be needed in order to
expand the reach of the program into local communities and to fulfill
the legislative intent.
FISCAL 2002 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, the Centers for Disease Control and the Health Resources
Services Administration.
--Epilepsy Program at the Centers for Disease Control and
Prevention.--The Epilepsy Foundation supports a $3 million
dollar increase in funding for the CDC epilepsy program.
--Health Resources and Services Administration.--The Epilepsy
Foundation supports an initial investment of $3 million in
order to create demonstration projects to improve access to
health care for people with epilepsy.
--Doubling the National Institutes of Health Budget.--The Epilepsy
Foundation supports the efforts to double the funding for the
NIH, particularly the National Institute of Neurological
Disorders and Stroke (NINDS). In keeping with this effort, we
support an increase to $1,370.6 million for NINDS in fiscal
year 2002. The Foundation urges Congress to support a major
expansion of epilepsy research within NINDS. In 1999, NINDS
spent $74 million on epilepsy research. We are seeking a
commitment to double that amount by fiscal year 2005.
Thank you for the opportunity to submit testimony to the
Subcommittee. We look forward to working with you in the 107th
Congress.
______
Prepared Statement of the Facioscapulohumeral Muscular Dystrophy
Society
Mr. Chairman, it is a great pleasure to submit this testimony to
you today.
My name is Daniel Paul Perez, of Lexington, Massachusetts, and I am
testifying today as President & Chief Executive Officer (CEO) of the
Facioscapulohumeral Muscular Dystrophy Society (FSH Society, Inc.) and
as an individual who has this devastating disorder.
We are excited to report that during the past several months, the
National Institutes of Health (NIH) have announced a series of
initiatives to accelerate research on Facioscapulohumeral Muscular
Dystrophy (FSHD). For the first time since its inception, the NIH has
requested grant applications whose purpose is to explore and develop
research that will broaden the base of knowledge on FSHD. We are
indebted to you, Senator Arlen Specter, as well as Representative John
Porter, Chairman U.S. House of Representatives Subcommittee on Labor,
HHS, Education and Related Agencies, formerly of U.S. House of
Representatives, as well as the directors and staff of the National
Institute of Neurological Disorders and Stroke (NINDS) and the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at
the NIH for this progress.
The FacioScapuloHumeral (FSH) Society, incorporated in 1991, solely
addresses specific issues and needs regarding facioscapulohumeral
muscular dystrophy (FSHD). 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 $650,000 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.
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 and their children and
grandchildren as well.
We are in an unprecedented time with the publication of the entire
human genome sequence. We have spent an enormous amount of money in
genomic research that is coming to fruition and we hope to begin to
realize the payoff for this investment. However, this chapter is not
closed and we are not done with understanding FSHD. FSHD is a complex
and difficult disease and the mechanism of this disease is tightly
bound to the next steps for genome research. FSHD is an enormously rich
disease to study with its involvement in telomeres, repeats,
chromosomal ``cross-talk'', new protein and DNA models for
transcription of the genome, and many other new areas outlined for
investigation by the entire genome community as critical areas for the
next steps to understanding how the human genome and physiome works.
FSHD may well be the only human disease that can be used as a model for
the next generation of novel genomic inquiry.
A decade of progress in FSHD 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.
FSHD, in particular, and muscular dystrophy in general appear to be
of little interest to the pharmaceutical industry, biotechnology
industry and Wall Street. No privately or publicly owned company is
currently pursuing FSHD research. Unlike Alzheimer's, Parkinson's
disease or breast cancer with hundreds of millions of research dollars
from the NIH supplemented by the enormous investments from the
pharmaceutical and biotechnology sector, FSHD has nowhere to go in the
private sector. We rely totally on NIH funding and that of voluntary
health organizations which raise research funds from the public, to
advance knowledge in this field.
Neuromuscular and muscle disease has one of the highest cost-of-
disease burdens in the U.S. economy. Yet, of $20.5 billion annually
given to NIH, approximately $19 million is spent on all muscular
dystrophy research and, of that amount, conservatively $450,000 is
currently being spent on the third most prevalent and third largest
dystrophy, FSHD. Clearly, the muscular dystrophies are significantly
under-funded by NIH. In last year's testimony, we reported the NIH had
not responded to the past three years of House and Senate Reports
accompanying the appropriations bill Language. We are pleased to report
a very different picture this year.
The FSH Society with the NINDS, the NIAMS and the and the NIH
Office of Rare Diseases (ORD) held ``The 3rd International Conference
on the Cause and Treatment of FSHD'' on Monday, May 8, 2000. The
research community, the clinical community, the observers and the NIH
related experts agreed that it was a truly outstanding, top-rate and
excellent meeting. We successfully assembled the leading FSHD
researchers from all over the world at the NIH in Bethesda, Maryland
where they shared their findings with each other and the NIH. The
Directors and Staff at the NIH developed an excellent program to aid in
the development of a portfolio for FSHD. The Research Planning
Conference held Tuesday, May 9, 2000 generated a multitude of ideas on
how to move forward on the FSHD agenda.
The May 9, 2000 baseline of recommendations by expert scientific
panel on FSHD for evaluating priorities is as follows and to date the
NIH is beginning to accomplish the sixteen items listed in this set.
Recommendations for future directions, organized by topic, are listed
as follows:
A. Molecular Processes; 1. Characterize the molecular pathogenesis
of FSHD; elucidate the role of the repeats associated with the disease
as well as what causes their deletion; 2. Determine the relationship
between repeat length and its effect on the degree to which disease is
manifested (penetrance); 3. Determine the gene sequence and whether the
repeats are acting as suppressors or insulating units; 4. Clarify how
similarity of regions on chromosomes 4 and 10 may relate to FSHD.
B. Tissue Changes; 5. Characterize changes in muscle as the disease
develops; 6. Determine basis of differential involvement of muscles; 7.
Explore the role of inflammation in FSHD; 8. Study properties of muscle
cells derived from affected tissue.
C. Possible Therapies; 9. It was speculated that it may become
possible to repair the disease locus by selected and targeted addition
of 3.3 kb repeats to the disease locus on chromosome 4; 10. The
modification of cultured FSHD regenerative muscle cells that would
reverse their higher sensitivity to oxidative stress. Such cultured
cells, with better ability to respond to oxidative stress, might then
be used for treatment of patients.
D. Population Based Studies; 11. Establish patient registries and
recruit additional families for study; 12. Determine if a nonstandard
locus produces FSHD.
E. Resources; 13. Create new animal models; 14. Facilitate use of
differential gene and protein expression techniques; 15. Promote
development and use of non-invasive imaging techniques; 16. Enhance
formation of clinical and basic research consortia.
Each year anew the FSH Society defines, at the request of the
entire international and global molecular genetics and clinical
research community, the most crucial issues in FSHD research today and
in the coming several years--these following nine areas represent the
majority of efforts to be made given recent advances in technology,
science and understanding of FSHD.
A. An International clinical and molecular data (resource) base.
Although a complicated issue for several reasons (homogeneity of
clinical and genetic data, access etc.), presence of such a facility
should greatly improve; 1. our insight in the natural history, and
genotype-phenotype relationships as support for patient counseling and
management; 2. the availability of biological material (DNA, cell
lines, muscle biopsies etc.) for research purposes; the design of
(homogeneous) clinical trials.
B. Non-chromosome 4q families; large enough to allow linkage
analysis and gene isolation. Identification of a second FSHD gene
should greatly facilitate the identification of crucial (rate-limiting)
molecular pathways. This might help direct our thinking on (gene)
therapy.
C. Large scale profiling of thousands of components to identify
molecular pathways leading to FSHD and targets amenable for
intervention. Attention should be given to; 1. RNA (transciptomics).
RNA reflects the steady-state transcription situation, but might be
only a meager reflection of the true (patho)biology. This work is
ongoing in several centers; 2. Protein (proteomics). The protein
components reflect the real biological executive situation. Proteomics
is much more complicated than transcriptomics, but may give much more
information; 3. Metabolites (metabolomics). In the near future, we will
have technologies at our disposal to identify and quantify metabolites,
the individual steps (substrates) of metabolic pathways. These
compounds may crucially determine the actual pathology and phenotype.
D. Cellular and animal models. It is very likely that the
generation of cellular and animal models will be pivotal, not only for
the generation of therapeutic means, but also to help identifying the
molecular basis of FSHD itself. In all likelihood, several approaches
have to be followed; 1. Transgenic mouse models. Two different
approaches can be envisaged: models for individual candidate genes,
identified in the chromosome 4q region or elsewhere and general models
in which large genomic regions of chromosome 4q and chromosome 10q,
including the telomeres are transferred and integrated, preferably at
mouse telomeres. These latter models will approximate the human
situation and allow studies on the cause and consequences of the inter-
and intra-chromosomal interactions and rearrangements in relation to
FSHD; 2. Other animal models. For specific questions on position
effects variegation etc., simpler models, like Drosophilia, and yeast
may be very useful.
E. Chromatin structure in and adjacent to the region where the FSHD
deletions occur. Including; 1. factors predisposing to illegitimate
recombination; 2. abnormally expressed genes in FSHD.
F. Better understanding of abnormalities of the small blood vessels
of the retina at the back of the eye in FSHD patients. Including; 1.
why children with a more severe or even sporadic form of FSHD are more
likely to develop this symptomatic form of retinal disease; 2. an
unidentified additional genetic peculiarity which renders some FSH
individuals peculiarly susceptible to symptomatic retinal disease; 3.
whether retinal, cochlear and skeletal muscle abnormalities in FSH
represent different effects of the same mutation or otherwise are the
results of abnormalities of adjacent genes; 4. the possibility that
such pleitropic effects are mediated by inflammation and/or
``environmental'' factors.
G. Clinical, molecular genetic study and genotype/phenotype
correlation of facioscapulohumeral muscular dystrophy phenotype and
facioscapuloperoneal muscular dystrophy phenotype.
H. Clinical trials. It is likely that new clinical trials will be
launched on basis of hints in other (muscular) disorders. Access to
well characterized (e.g. with respect to clinical phenotype and genetic
constitution) patients cohorts is crucial for proper evaluation.
I. Molecular pathway based therapy. Increasing insight in the
molecular pathways of FSHD, already available and hopefully even more
so in the near future, will form the rationale for novel treatment
strategies. It is difficult to predict whether these efforts will be
DNA-based or pharmacological. In any case, such experimental approaches
have to be developed in (transgenic) animal models; another argument
for investing in versatile models.
The NIH has the tremendous capacity to quickly enhance research in
the above project areas through its intramural and extramural research
programs. The FSH Society and Congress have been repeatedly informed
that the NIAMS has invested considerable resources into the newly
formed Laboratory of Physical Biology (LPB) at the NIAMS to strengthen
its intramural program on muscle diseases and in FSHD muscular
dystrophy research. The LPB mission is to study of biological systems
using leading-edge physical approaches, and muscle contraction,
regulation, structure, and function. The NINDS also has a considerable
resource to offer with its intramural research staff and programs.
Additionally, the NINDS and NIAMS staff are currently consulting with
members of the extramural community to build a research portfolio on
FSHD. This year should bring a concerted effort by the NIH NINDS/NIAMS,
the National Institute for Human Genome Research (NIGHR) and its NIH
Intramural Sequencing Center (NISC) to accelerate extramural research
by offering and bridging intramural resources with the extramural
community of researchers and clinicians thereby making the above
research viable. The NIH has begun to make great progress in its
extramural programs covering FSHD and the immediate proactive inclusion
of intramural resources and programs will help rapidly accelerate
solutions and understanding of FSHD.
On November 8, 2000, the first of the three major announcements was
made by NIH as ``Exploratory Research on Facioscapulohumeral Muscular
Dystrophy''. On December 11, 2000, the second announcement was made on
the establishment of a National Patient Registry at the University of
Rochester Medical School for FSHD and Myotonic muscular dystrophy. On
January 4, 2001, the third announcement was made for a three year
program ``Therapeutic and Pathogenic Approaches for the Muscular
Dystrophies.''
We are delighted with these steps towards finding solutions for
FSHD. We note with cautious optimism that the NIH has begun the process
to establish a portfolio in the causes and treatment of FSHD as called
for in the past three years of House and Senate Report Language.
However, we are only beginning the process. Difficult work lies ahead
involving establishing population databases, developing research
resources such as a mouse model, understanding the molecular process,
understanding tissue changes, the development and clinical trials of
possible therapies and population based studies.
Mr. Chairman, we are watching with interest the response of the
scientific community to the announcements of NIH referenced above. We
are concerned that, despite these announcements, the exciting
scientific questions about this disease and progress in genomics and
the tremendous need of patients for therapies, that the response of the
scientific community will be less than optimal. We hope we are wrong.
We are concerned that there is not an attitude of confidence that FSHD,
muscular dystrophy or muscle biology is of significant importance at
NIH over the long term to justify the investment by researchers in this
field. After all it has taken the FSH Society since 1994 to encourage
Congress and NIH to move this far, we feel the Committee should
consider earmarking funding in this area sufficient to encourage
researchers to make a commitment to pursue this difficult and often
frustrating area of investigation.
We request that the Committee consider earmarking an amount of not
less than fifteen (15) million dollars for FSHD research.
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 and we urge the United States Government to allocate a
proportion of our tax burden toward research on FSHD.
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 and all other muscular dystrophies.
Mr. Chairman, again, thank you for providing this opportunity to
testify before your Subcommittee.
______
Prepared Statement of the Foundation for Ichthyosis & Related Skin
Types
Mr. Chairman and members of the Subcommittee: The Foundation for
Ichthyosis & Related Skin Types (F.I.R.S.T.) wishes to thank the
members of this subcommittee for your past support of the National
Institutes of Health (NIH) and the National Institute of Arthritis,
Musculoskeletal and Skin Diseases (NIAMS). We appreciate the
opportunity to provide written testimony regarding funding for skin
disease research and the budget for NIAMS. F.I.R.S.T. is requesting
that the budget for the NIH/NIAMS be increased by 16.5 percent, which
will keep the NIH on track to doubling the budget by fiscal year 2003.
In 1992 a member of F.I.R.S.T. testified before this committee
regarding the need for a national registry for ichthyosis and related
disorders. Today, as a direct result of your interest and support, we
have the National Registry for Ichthyosis and Related Disorders. The
Registry's funding was just renewed for another four years and was
expanded to include molecular diagnosis. The registry helps generate
researcher interest in ichthyosis, and provides investigators with an
essential tool--a pool of affected individuals with a confirmed
clinical diagnosis. The availability of this pool of information
results in significant savings in research time and dollars, which
would have normally been spent identifying eligible patient
populations.
F.I.R.S.T. is a voluntary organization dedicated to providing
support, information, education and advocacy for individuals and
families affected by ichthyosis. F.I.R.S.T. supports research into
causes, treatment and a cure for ichthyosis.
Ichthyosis is a family of genetic skin diseases characterized by
dry, thickened, scaling skin. These diseases are caused by genetic
defects that are usually the result of genetic inheritance. Currently,
there is no cure for ichthyosis, and there are no truly effective
treatments.
Some forms of ichthyosis cause the skin to be very fragile and
blister easily. Scaling and flaking are continuous. The skin is tight
and cracked. The palms and soles can be thick, making something as
simple as holding a pencil or as natural as walking difficult and
painful. Overheating is dangerous and infections are a constant threat.
Our children are sometimes hospitalized for infections. Simple
medical procedures are complicated. Days and activities are planned
around skin care. Stares and questions from strangers are common. While
the physical aspects of ichthyosis are obvious, the blows to ones self-
esteem can be even more damaging. Currently, ichthyosis is a life-long
battle. Hopefully, this will change in the future.
We recognize this Subcommittee's strong history of bipartisan
support for medical research funding and the NIH. Recently new genes
have been discovered for several types of ichthyosis and related skin
types. Darier's disease, although not strictly an ichthyosis, was found
to be caused by mutations involving the ATP2A2 gene. Another ATPase
gene, ATP2C1, encoding another calcium pump was found this year to be
the cause of Hailey-Hailey disease. Patients with this condition have
more problems with blistering, but lesser problems with scaly skin than
patients with Darier's disease.
Two new genetic defects affecting the synthesis of cholesterol have
now been linked to ichthyosis. The affected enzymes, sterol 4
demethylase and sterol 7,8 isomerase, were first shown to cause
ichthyosis-like conditions in laboratory mice. Cholesterol is an
essential component of the plasma membrane that surrounds each cell,
and also of the membranes lying between the cells of the stratum
corneum. In these outer skin layers, cholesterol acts to prevent too
much evaporative loss of water from the interior of the body to the
drier atmosphere. Subsequently, several patients with the Conradi-
Hunermann-Happle syndrome, a condition that affects only females and
causes an ichthyosiform erythroderma in a swirling pattern during
infancy, along with abnormalities affecting the eye, bones and other
tissues, have mutations in the gene for sterol 7,8 isomerase. And
patients with CHILD syndrome, a condition also only affecting females
in a pattern of abnormalities but is limited to only one side of the
body, have had mutations affecting the sterol 4 demethylase in some
cases and the sterol 7,8 isomerase in others.
Several new causes of palmar plantar keratoderma (PPK) (thickened
outer skin mostly restricted to palms and soles) were identified this
past year. Striate PPK (bands of thickened skin along the digits) was
linked to mutations affecting two proteins, desmoglein I and
desmoplakin, that are constituents of desmosomes. Papillon Lefevre
syndrome is a palmar plantar keratoderma with severe periodontitis
(inflammation of the gums). This condition was found to be due
deficiency of a protease (enzyme that digests proteins), Cathepsin. The
last of the genetic breakthroughs this past year were the
identification of connexin gene mutations in two scaling skin
disorders. One of the skin diseases caused by a connexin mutation
(connexin 31 protein, encoded by the gap junction protein beta-3 gene)
is Erythrokeratodermia vanablis. Not all patients with EKV have been
found to have mutations in this gene, implying that other genes may
cause the same disease pattern. Also patients with different mutations
in this same gene do not have skin disease, but instead are deaf.
Mutations affecting another connexin, Connexin 26, also cause deafness
and some of these patients, in addition to deafness, have Vohwinkel's
PPK.
We are excited about this progress, and about the current research
into gene therapy. We are hopeful about the possibility for an
effective treatment or cure on the horizon, but at this point it is
still just hope. We continue to be frustrated by the lack of effective
treatment options.
Three years ago, this country embarked on a commitment to double
the National Institutes of Health (NIH) budget in five years.
F.I.R.S.T. requests that funding to the NIH continually be increased to
stay on track with that plan. It is very important to support this
initiative because the NIH is where most of the country's important
research originates. Research that involves any new discovery for any
skin disease is beneficial to all skin diseases. Since skin diseases
are so closely related, eventually these advancements will filter
across the board and possibly lead to discoveries in our particular
disease, ichthyosis. It is critical for fundamental research to be
continued as well. Even though each particular skin disease group wants
their particular disease to be the focus of increased research, it is
difficult to study any of these diseases if the basic function of skin
cells is not mastered.
Last year, Congress passed the Clinical Enhancement Act to provide
a loan repayment program for medical school graduates. F.I.R.S.T. asks
that funding for this program be supported and increased.
Young doctors are faced with enormous medical school loans after
graduation. Because of this debt, many young doctors choose professions
that provide higher salaries, which will help them reduce their debt
quicker. By supporting and increasing funding for the Clinical
Enhancement Act, this program will become stronger and encourage young
doctors to choose a career path in research. F.I.R.S.T. also requests
that federal appropriators support funding for a workshop to study and
record the current yearly medical costs related to skin diseases in
this country.
If the NIH is to unlock the mysteries of disease, translate the
recent research discoveries into new treatments for the bedside, it is
necessary that the appropriation for the NIH be a sizable, sustained
and stable effort. We hope that you will keep the faith with your
constituents, and provide the needed funds to the NIH.
On behalf of our members, those with ichthyosis and their families,
we thank this Congressional Subcommittee for their time and attention.
______
Prepared Statement of Families of Spinal Muscular Atrophy
Mr. Chairman and members of the Senate Appropriations Subcommittee
on Labor, HHS, Education and Related Agencies, Families of Spinal
Muscular Atrophy wishes to thank you for this opportunity to submit
written testimony for the record.
Mr. Chairman and Members of the Subcommittee, let me begin by
asking a question, what would you do if you were told your 10-week-old
son or daughter would not live to see his/her second birthday? Or, if
your child were beginning to walk, and then for some reason, unknown to
you, regressed to only crawling then eventually only sitting? For
families who have a child diagnosed with Spinal Muscular Atrophy these
are not hypothetical questions, these are real situations faced
everyday.
Spinal Muscular Atrophy (SMA) is the number one genetic killer of
children under the age of two. SMA is a vicious, debilitating genetic
disease that affects individuals indiscriminately and is more
widespread than anyone realizes. One in every forty people carries the
gene that causes SMA and one in every 6,000 babies is born with SMA.
Due to the various forms of SMA, the disease onset can be at any age.
SMA is a neuromuscular disease that affects the anterior horn
cells. Through great collaborative effort the scientific field has
identified the gene that causes SMA as well as determined the missing
protein and are well on their way to replacing it. By replacing this
missing protein it is hopeful that the disease will be eradicated and
that some damage might be repaired. With this knowledge and additional
National Institutes of Health (NIH) funding through the National
Institute of Neurological Disease and Stroke (NINDS), this information
will not only lead to a cure for SMA, but will also open doors through
this new technology to be used for other motor neuron and neuromuscular
diseases.
Families of S.M.A is a 100 percent volunteer organization whose
mission is to fund research, support families and create awareness.
Through the efforts of Families of S.M.A. scientists from all over the
world meet once a year to discuss and share the progress made in
research. Most recently we have asked that NINDS explore areas of
promising research, which were identified at the 2000 Families of SMA
International Workshop. This includes the development of a SMA basic
and clinical research portfolio through all available mechanisms, as
appropriate, including clinical trails of drug compounds capable of
activating SMN2 expression.
We wish to thank NINDS for their support in the Multi-Center
Creatine Study, but the continued development of a SMA research
portfolio is critical. In the very near future SMA will be involved in
drug development and/or stem cell therapy or gene replacement therapy.
The participation of NINDS in this endeavor is most important. We ask
the committee to encourage NINDS to explore areas which will be
identified at the 2001 Families of S.M.A. International Workshop which
is being held in June.
Mr. Chairman, on behalf of all the individuals suffering from the
various forms of SMA, thank you for your continued, strong leadership
for the bipartisan effort to double the NIH budget over five years.
Providing the NIH with a $3.4 billion increase in funding this year is
critical to individuals with SMA.
Thank you.
FACT SHEET ABOUT SPINAL MUSCULAR ATROPHY (SMA)
The Disease
Spinal muscular atrophy (SMA), the number one genetic killer of
children under the age of two, is a group of inherited and often fatal
diseases that destroys the nerves controlling voluntary muscle
movement, which affects crawling, walking, head and neck control, and
even swallowing.
Who is Affected
SMA is one of the most prevalent genetic disorders.
--One in every 6,000 babies is born with SMA. Of children diagnosed
before age two, 50 percent will die before their second
birthday.
--SMA can strike anyone of any age, race or gender.
--One in every 40 people carries the gene that causes SMA. The child
of two carriers has a one in four chance of developing SMA.
Types of SMA
--Type I, or Werdnig-Hoffman Disease, is the most severe form of SMA.
Children with Type I tend to be weak and lack motor
development, rendering movement difficult. Children afflicted
with Type I cannot sit unaided and have trouble breathing,
sucking and swallowing. Type I SMA strikes infants between
birth and six months.
--Type II, is slightly less severe. Type II patients may be able to
sit unaided or even stand with support and usually do not
suffer from feeding and swallowing difficulties. However, they
are at increased risk for complications from respiratory
infections. Type II SMA affects infants between seven and
eighteen months old.
--Type III, also known as Kugelbert-Welander Disease, is the least
deadly form of childhood-onset SMA. Type III patients are able
to stand, but weakness is prevalent and tends to eventually
sentence its victims to a wheelchair. Type III SMA strikes
children after the age of eighteen months, but can surface even
in adulthood.
--Type IV, is the adult form of the disease in which symptoms tend to
begin after age 35. Symptoms usually begin in the hands, feet
and tongue, and spread to other areas of the body.
--Adult Onset X-Linked SMA, also known as Kennedy's Syndrome or
Bulbo-Spinal Muscular Atrophy, occurs only in men. Facial and
tongue muscles are noticeably affected. Like all forms of SMA,
the course of the disease is variable, but in general tends to
progress slowly.
SMA does not affect sensation and intellectual activity in
patients. It commonly is observed that patients with SMA are unusually
bright and sociable.
Testing
Prenatal counseling is available to couples who are carriers of SMA
or who have lost a child to SMA.
______
Prepared Statement of the Hepatitis Foundation International
Chairman Specter and members of the Committee. I am Thelma King
Thiel, Chairman and Chief Executive Officer of the Hepatitis Foundation
International (HFI), representing the Board of Directors and members of
425 patient support groups across the nation, the majority of whom
suffer from chronic viral hepatitis.
We commend the Committee for allocating initial funds that have
enabled CDC to make tremendous strides in efforts to understand
hepatitis and to control it through universal immunization and
education programs.
Although all five types of viral hepatitis are preventable, we are
currently dealing with an ``epidemic of discovery'', people who are
already infected with the hepatitis C virus because of lack of
information about transmission, appropriate vaccines and effective
treatments to stop the spread to others. Hepatitis B has been eclipsed
by hepatitis C even though we have effective tools to eradicate
hepatitis B. Lack of funds and integrated prevention activities
contribute to the ongoing transmission of hepatitis B that claims 5,000
lives each year. If high risk individuals who attended STD clinics, or
those who have been incarcerated had been vaccinated against hepatitis
B in the early 1980s when the vaccine was approved, we would not be
dealing with the large numbers of individuals who are chronically
infected and in need of liver transplants today. It is time to make a
major investment in immunization and preventive education to bring
these diseases under control. All newborns, young children, young
adults, and especially those who participate in high-risk behaviors
must be a priority for immunization initiatives. We need to provide
effective preventive education in our elementary and secondary schools
to help children avoid the ravages of health problems resulting from
viral hepatitis infection.
The Hepatitis Foundation International has worked closely with the
Centers for Disease Control and Prevention through cooperative
agreements in addition to contributing private funds for specific
projects. HFI provided significant independent support and co-sponsored
the Hepatitis C Teleconference for healthcare providers in 1997.
Collaboration with CDC has enabled the Foundation to develop and
distribute thousands of award winning videos and innovative, effective
educational materials nationwide dealing with liver wellness, hepatitis
and substance abuse prevention. Many of these items are available in
several languages. Teachers, healthcare providers, public health
officials, personnel in corrections and juvenile detention centers,
governmental and non-governmental agencies all need these tools.
Funding is needed to duplicate and distribute many more to those on the
front line in the battle against hepatitis and substance abuse.
Prevention can save lives today. We need to train health care
professionals in effective communication and counseling techniques. We
need public awareness campaigns to alert individuals to assess their
own risk behaviors. We need to motivate them to seek medical advice . .
. to encourage them to be immunized against hepatitis A and B . . . and
to stop drinking any alcohol if they have participated in risky
behaviors that may have exposed them to hepatitis C.
Mechanisms are in place to provide screening, referral services,
medical management, counseling, and prevention education for those who
have HIV/AIDS. Funds must be made available to expand all of these
services, including immunization, to those who are infected by
hepatitis viruses.
HFI recommends an increase of $15 million for further
implementation of CDC's Hepatitis C Prevention Strategy. This increase
will further the development of state-based prevention programs by
increasing the number of state health departments with CDC funded
coordinators from 16 to 51 covering each state and by implementing
demonstration projects to evaluate ways to integrate hepatitis C and
hepatitis B prevention efforts into existing public health programs.
HFI recommends that $10 million be added to CDC's budget to train and
maintain hepatitis coordinators in every state to implement prevention
and management strategies.
The CDC Prevention Research Centers Program plays a critical role
in reducing the human and economic costs of disease. CDC should be
commended for its decision to fund the most meritorious applications in
the fiscal year 2001 competition, regardless of geographic location of
the applicants with respect to other Prevention Research Centers.
Preventive education is cost effective. CDC estimates that for every $1
spent on school-based drug and alcohol, tobacco, and sexuality
education, $14 are saved in avoided health care costs.
CDC currently funds 24 prevention research centers at schools of
public health and schools of medicine across the country. An additional
two centers will be selected using a portion of the $23 million the
Congress dedicated to the program in fiscal year 2001. However, core
funding for prevention centers has been decreasing since this program
was first funded in 1986 from an average of $800,000 per center to
$580,000 in fiscal year 2000.
In order to continue to build this flagship CDC extramural research
program, HFI requests Congress to increase the core funding to $40
million for Prevention Research Centers in fiscal year 2002.
Past investment in NIH has led to an explosion of knowledge that
has advanced understanding of the biological basis of disease and
development of strategies for disease prevention diagnosis, treatment,
and cures. Countless medical advances have resulted in a direct benefit
to the lives of all Americans. NIH-supported scientists remain our best
hope for sustaining the momentum in the pursuit of scientific
opportunities and new health challenges. Research studies to learn why
some HCV infected individuals resolve their infection spontaneously may
prove to be life saving information for many who are currently
infected. The answer may provide a cure for others.
To achieve the proposed doubling of the NIH budget over the five-
year period from fiscal year 1999 to fiscal year 2003, the Hepatitis
Foundation International joins with Congress and the new Administration
in supporting an appropriation of $23.7 billion for NIH in fiscal year
2002 representing a 16.5 percent increase. HFI also recommends a
comparable increase of 16.5 percent in hepatitis research funding at
the National Institute of Diabetes and Digestive and Kidney Diseases
and the National Institute of Allergy and Infectious Diseases. An
additional $4 million is needed to extend and expand the HALT-C to
study the pathogenesis and treatment of hepatitis C and to understand
why some patients respond to treatment and others do not.
A significant portion of increases for these Institutes should be
earmarked to conduct studies among groups of patients that have been
neglected in overall research initiatives. They include:
--African Americans--to identify reason why they do not respond to
antiviral agents in the treatment of chronic hepatitis C.
--Children and Adolescents--Pediatric liver research lacks
appropriate funding to address the many diseases, including
viral hepatitis, that affect children.
--Renal Dialysis Patients--Many are HCV infected and outcomes of
treatment need more investigation.
--HIV/HCV Positive Patients--Co-infections need special investigation
--Hemophilia Patients--Co-infection with HIV needs further study.
Victims of hepatitis suffer emotionally as well as physically. They
experience discrimination in employment, strained personal
relationships and severe depression when treatments fail to control
their illness as well as during their treatment. We look forward to
working in collaboration with CDC, NIH, health departments and other
voluntary organizations to bring viral hepatitis under control.
I would be happy to answer any questions you may have. Thank you
for providing this opportunity to present our testimony.
______
Prepared Statement of the Humane Society of the United States
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 7.7 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 2002 budget:
--$6 million for planning and construction to launch the national
chimpanzee sanctuary system authorized by Public Law 106-551;
--$3 million to expand the work of the Interagency Coordinating
Committee for the Validation of Alternative Methods (ICCVAM),
authorized by Public Law 106-545, coupled with Committee Report
language encouraging federal agencies to avail themselves of
ICCVAM's expertise and efficient review process.
CHIMPANZEE SANCTUARIES
We are very pleased that Congress last year enacted H.R. 3514
(Public Law 106-551), the Chimpanzee Health Improvement, Maintenance,
and Protection Act, which authorized up to $30 million to establish and
operate a federal chimpanzee sanctuary system for chimpanzees no longer
used in medical research. Introduced by Senators Bob Smith (R-NH) and
Richard Durbin (D-IL) and Representative Jim Greenwood (R-PA), this
legislation earned the bipartisan support of 24 cosponsors in the
Senate and 143 cosponsors in the House. It had the endorsement of more
than 100 scientists, many of whom are renowned experts in the field of
chimpanzee research. The legislation was approved by unanimous voice
vote in both chambers and was signed into law on December 20, 2000.
This common-sense statute is designed to help animals who are
deemed by the Secretary of Health and Human Services to be ``surplus''
for medical research, but who are still being warehoused in expensive
federally-supported laboratory cages. As determined by the
Congressional Budget Office (CBO), the sanctuaries envisioned by this
law will provide a much higher quality of life for these animals. They
will also serve American taxpayers well, by saving millions of dollars
over the course of the next several years ($4 million annually, after
initial construction costs). These savings are primarily due to the
fact that sanctuary facilities, which offer a more naturalistic
environment and opportunities for social interaction, can be built and
operated at significantly lower cost than laboratory facilities.
Housing chimpanzees in sanctuaries is estimated to cost $8-$15 per day
per animal, compared to the $20-$30 per day per animal that the federal
government currently spends to house them in lab cages. In addition,
the statute creates a public-private partnership, requiring private
sector matching dollars to complement the federal government's share
(the private match is 10 percent of construction costs and 25 percent
of operating costs).
The statute follows the recommendations of a National Research
Council (NRC) report commissioned by the National Institutes of Health
(NIH) and released in 1997, ``Chimpanzees in Research: Strategies for
Their Ethical Care, Management, and Use.'' In 1986, NIH launched an
initiative to breed chimpanzees--mistakenly thought to be useful models
for AIDS research--creating a surplus of several hundred chimpanzees
who are no longer used in medical research. According to the NRC
report, the government is spending more than $7 million annually on
maintenance of chimpanzees. The report recommends a breeding moratorium
and opposes euthanasia of chimpanzees as a means of population control,
noting that ``[s]ome of the best and most caring members of the support
staff, such as veterinarians and technicians would, for personal and
emotional reasons, find it impossible to function effectively in an
atmosphere in which euthanasia is a general policy, and might resign.''
The report also specifically recommends: ``The concept of sanctuaries
capable of providing for the long-term care and well-being of
chimpanzees that are no longer needed for research and breeding should
become an integral component of the strategic plan to achieve the best
and most cost-effective solutions to the current dilemma.''
To implement this law in a timely and efficient way, we
respectfully request that the Committee direct NIH to allocate $6
million in fiscal year 2002 for planning and construction of the
national chimpanzee sanctuary system. In recognition of budget
constraints, this requested funding level falls well below the $11
million outlays that CBO projected for the first year of the system.
But we believe it is enough to ensure that implementation will move
forward quickly, so that the chimpanzees and taxpayers can begin to
benefit as Congress intended.
INTERAGENCY COORDINATING COMMITTEE FOR THE VALIDATION OF ALTERNATIVE
METHODS (ICCVAM)
We are also very pleased that Congress enacted H.R. 4281 (Public
Law 106-545) last year by unanimous voice vote in both chambers. This
legislation, introduced by Senator Mike DeWine (R-OH) and
Representatives Ken Calvert (R-CA) and Tom Lantos (D-CA), earned the
bipartisan support of 5 Senate cosponsors and 73 House cosponsors, and
was signed into law on December 19, 2000. This statute strengthens and
makes permanent the Interagency Coordinating Committee for the
Validation of Alternative Methods (ICCVAM). We hope the statute will
increase acceptance of more animal-friendly test methods by
streamlining the process by which these methods are validated and
easing institutional barriers within federal agencies that discourage
their use.
ICCVAM performs an invaluable function for regulatory agencies,
industry, public health, and animal protection organizations by
assessing the validation of new, revised and alternative toxicological
test methods that have interagency application--including methods that
replace, reduce, and refine the use of animals in testing. After
appropriate independent peer review of a test method, ICCVAM provides
its assessment of the test to the federal agencies that regulate the
particular endpoint that the test measures. In turn, the federal
agencies maintain their authority to incorporate the validated test
method as appropriate for the agencies' regulatory mandates. This
streamlined approach to assessment of validation of new, revised and
alternative test methods has reduced the regulatory burden of
individual agencies, provided ``one-stop shopping'' for industry,
animal protection, public health and environmental advocates to
consider test methods, and set uniform criteria for what constitutes a
validated test method.
ICCVAM arose from an initial mandate in the NIH Revitalization Act
of 1993 for the National Institute of Environmental Health Sciences
(NIEHS) to ``(a) establish criteria for the validation and regulatory
acceptance of alternative testing methods, and (b) recommend a process
through which scientifically validated alternative methods can be
accepted for regulatory use.'' In 1994, NIEHS established an ad hoc
ICCVAM to write a report that would recommend criteria and processes
for validation and regulatory acceptance of toxicological testing
methods that would be useful to federal agencies and the scientific
community. Through a series of public meetings, interested stakeholders
and agency representatives from 14 regulatory and research agencies
developed NIH Publication No. 97-3981, ``Validation and Regulatory
Acceptance of Toxicological Test Methods.'' This report has become the
``sound science'' guide for consideration of new, revised and
alternative test methods by the federal agencies and interested
stakeholders. After publication of the report, the ad hoc ICCVAM moved
to standing status under the NIEHS' National Toxicology Program
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM). Representatives from federal regulatory and research
agencies have continued to meet, with advice from NICEATM's Advisory
Committee and independent peer review committees, to assess the
validation of new, revised and alternative toxicological test methods.
Since then, two methods have undergone rigorous assessment and been
deemed scientifically valid and acceptable. The first method,
Corrositex, is a replacement for animal-based dermal corrosivity tests
for some chemicals. The second, the Local Lymph Node Assay, is a
reduction and refinement of an animal test for the skin irritation
endpoint.
The open public comment process, input by interested stakeholders,
and the continued commitment by various federal agencies have led to
ICCVAM's success so far. Now, with enactment of Public Law 106-545,
ICCVAM is poised to accomplish even more in terms of streamlining the
validation of other new, revised and alternative test methods. For the
past few years, NIEHS has provided approximately $1 million annually to
NICEATM for ICCVAM activities. In order to ensure that federal
regulatory agencies and their stakeholders can more fully benefit from
the work of ICCVAM, we respectfully urge the Committee to direct NIEHS
to allocate $3 million for ICCVAM activities in fiscal year 2002.
Funding at this level will cover FTEs, independent peer review
assessment of test methods, meeting expenses, and other activities as
deemed appropriate by the Director of the NIEHS. In addition, we
respectfully request inclusion of the following Committee Report
language:
``The Committee directs that $3 million from the National Institute
of Environmental Health Sciences budget be allocated to the National
Toxicology Program's Interagency Center for the Evaluation of
Alternative Toxicological Test Methods for Interagency Coordinating
Committee for the Validation of Alternative Methods (ICCVAM) activities
during fiscal year 2002. The Committee supports the assessment of
scientific validation of new, revised and alternative toxicological
test methods by the ICCVAM. The Committee directs the regulatory and
research agencies, including, but not limited to, the National
Institute of Environmental Health Sciences, Food and Drug
Administration and Environmental Protection Agency, to use the
expertise and credibility of the ICCVAM for these assessments to
streamline their individual consideration of new, revised and
alternative toxicological test methods. The Committee also urges the
federal regulatory and research agencies to incorporate scientifically
validated new, revised and alternative test methods into their
regulations, requirements and recommendations in an expeditious
manner.''
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 2002. We hope the Committee will be
able to accommodate these two requests affecting animals across the
United States. Thank you for your consideration.
______
Prepared Statement of the Huntington's Disease Society of America
SUMMARY OF RECOMMENDATIONS
The Huntington's Disease Society of America (``HDSA'') urges
Congress to increase funding for medical research on neurodegenerative
diseases and disorders, especially Huntington's Disease (``HD''),
through budgetary increases to the National Institutes of Health
(``NIH'').
Specifically, HSDA encourages Congress to provide at least a 16.5
percent increase over fiscal year 2001 for NIH, raising the funding
levels from $20.3 billion to $23.7 billion, as recommended by the Ad
Hoc Group for Medical Research Funding. Within NIH, HDSA recommends at
least a commensurate increase for the National Institute of
Neurological Disorders and Stroke (``NINDS''), the National Institute
of Mental Health (``NIMH''), and the National Institute on Aging
(``NIA''), each of which support a modest portfolio of HD research.
These increases would allow for further research on the diagnosis,
treatment and cure for HD, a debilitating and devastating
neurodegenerative disease.
HUNTINGTON'S DISEASE SOCIETY OF AMERICA
HDSA is a national voluntary non-profit health organization
dedicated to finding a cure for Huntington's Disease while providing
services and support for those living with HD and their families.
Founded in 1967, HDSA promotes and supports both basic and clinical HD
research, aids families throughout the continuum of HD, and educates
the public and healthcare professionals about HD.
Private donations coupled with the tireless fundraising efforts of
HDSA chapters around the country make the HDSA Research Grants program
possible. These grants help innovative research projects develop
sufficiently to attract funding from other sources, particularly the
NIH, which do not provide funds for projects in their early stages of
development.
HUNTINGTON'S DISEASE
HD is an inherited degenerative brain disorder that results in the
loss of both mental faculties and physical control. It is caused by the
mutation of a single gene. The disease afflicts approximately 30,000
Americans, while 150,000-200,000 Americans are at-risk of inheriting it
from a parent. Each child of a parent with the HD gene has a 50/50
chance of inheriting the disease. Every person who inherits the HD gene
will eventually develop the disease. HD does not skip generations; if
one does not inherit the gene, one cannot pass it on. HD affects as
many people as Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's
disease) or Cystic Fibrosis.
Symptoms of HD may affect cognitive ability or mobility and include
depression, mood swings, forgetfulness, clumsiness, involuntary
twitching and lack of coordination. As the disease progresses,
concentration and short-term memory diminish and involuntary movements
of the head, trunk and limbs increase. Walking, speaking and swallowing
abilities deteriorate. Eventually the person is unable to care for him
or herself. Death often results from complications such as choking,
infection or heart failure.
The costs to society are both direct and indirect, and include
medical expenses, loss of productivity in the workplace by patients and
caregivers (oftentimes spouses or children), disability claims, and
long-term care expenses. On an annual basis, the direct and indirect
costs of HD to society total over $2 billion.
RESEARCH RECOMMENDATIONS
Once thought of as a rare disease, HD is now considered to be one
of the more common hereditary diseases. Although HD is classified as a
more common hereditary disease, researchers have yet to discover an
effective treatment to slow the progression of HD or a cure for this
deadly disease. Over the past decade, there have been breakthroughs in
HD research and researchers continue to aggressively build upon these
advancements. The outlook for treating and curing HD has never been
more promising.
In 1993, researchers identified the gene that causes HD. Such a
discovery has made possible a predictive test for HD. Individuals at-
risk for HD can now find out whether they carry the gene before
symptoms arise. This discovery has been a springboard for laboratory
research. It has led to the creation of a mouse model of Huntington's
Disease, referred to as a ``transgenic'' mouse. The HD gene is inserted
into mouse DNA, thus causing the mouse to develop HD symptoms. Using
transgenic mouse models, researchers have identified and characterized
pathogenic hallmarks; the aberrant events that occur in the brain cells
of the subjects with HD.
In an effort to transform basic research data and determine how it
can be applied to treat or cure HD in humans, clinical trials must be
established. Patients with HD and their families are desperately
depending on the positive outcomes of these clinical trials to improve
their quality of life. However, prior to commencement of clinical
trials, researchers must employ the technology of high throughput
screens for drug development. This technique rapidly tests a very large
number of compounds to see if they have a desired positive effect.
Compounds that have a positive effect then go through more research to
determine if they could become a viable drug therapy for human clinical
trials.
HDSA appreciates the commitment that Congress has made to double
the NIH budget by fiscal year 2003. Medical research endeavors and
America's patients are benefiting tremendously from this five-year
effort. This initiative will pay dividends for decades to come.
However, despite the fact that HD is considered one of the more common
hereditary disease, the NIH Office of Budget estimates that only one-
third of 1 percent of NIH's sizeable $20.3 billion budget will be
dedicated to HD research in fiscal year 2001. The level of NIH
resources allocated to HD research is inadequate, especially
considering the recent substantial increases in the NIH budget. NIH
must elevate the priority level of HD research.
HDSA recommends that Congress urge the NINDS, NIMH, and NIA to
increase RO1 funding for HD and other neurodegeneration research by 15
percent for fiscal year 2002. Using such an increase in resources,
researchers will develop more models of HD, including fruit fly models
and worm models, and will test compounds and genes which may ameliorate
or prevent HD. Additionally, researchers hope to target the aberrant
events that occur in brain cells of subjects with HD and test
approaches to prevent or mitigate these adverse occurrences.
HD serves as a prototype disease caused by the mutation of a single
gene. Therefore, advances made in the understanding and treatment of HD
will increase scientists' ability to derive the mechanism and
therapeutic approaches for several similar diseases, including
Alzheimer's Disease, ALS and Parkinson's Disease.
CONCLUSION
HD continues to take a huge emotional and financial toll on
America's families. HDSA appreciates Congress' commitment to biomedical
research and to the NIH in recent years. However, more effort is
needed. Congress must maintain the momentum, and in some cases, devote
even more resources. HDSA is grateful for the opportunity to present
its views on fiscal year 2002 appropriations. Please contact Barbara
Boyle, HDSA National Executive Director/CEO, at (212) 242-1968, if you
have further questions.
______
Prepared Statement of the Immune Deficiency Foundation
Mr. Chairman, thank you for the opportunity to submit testimony on
primary immune deficiency disorders and the need for continued research
and education on these diseases.
Primary immune deficiency diseases are inherited disorders in which
parts of the body's immune system are missing or do not function
properly. The World Health Organization has identified more than 70
different primary immunodeficiency diseases. These disorders are very
under diagnosed, but we believe that more than 45,000 Americans, of all
races, ages, and gender. Fortunately, most primary immune deficient
patients, once diagnosed, are able to maintain their health through
infusions of a pooled plasma derivative known as intravenous
immuneglobulin (IGIV) every three to four weeks for the rest of their
life. However, if primary immunodeficiency diseases are not properly
diagnosed and treated, they can lead to serious illness and early
death.
The Immune Deficiency Foundation (IDF) is the national non-profit,
charitable organization dedicated to improving the health of primary
immune deficient patients through research and education. Headquartered
in Towson, Maryland, IDF was founded in 1980 by a group of parents of
primary immune deficient children who wanted to focus attention on the
needs of primary immune deficient patients, physicians, and
researchers.
IDF provides a wide variety of patient and family services, medical
research and education, and advocacy for issues related to these
diseases. Specifically, the Foundation acts as an information
clearinghouse for newly diagnosed patients and provides these
individuals with an opportunity to interact with other primary immune
deficient patients and families. Oftentimes, the most reassuring call a
parent of a newly-diagnosed child will make is not to a doctor or
hospital, but to one of our local patient representatives with his or
her own children playing loudly in the backyard. This opportunity to
speak directly and frankly to another parent in a similar situation
often is the first chance to seek support and results in a level of
comfort that with proper treatment their child can grow up with a near-
normal life.
The foundation is also active in medical research to try to better
define and diagnose these diseases. While we search for these longer-
term answers, we are also looking to improve current treatment options
for patients as well as improve understanding of these diseases within
the medical community. Because primary immune deficiency is a rare
disease, we focus on providing educational opportunities such as
visiting professorships and grand rounds for physicians and medical
students who might otherwise not be exposed to this knowledge. The
foundation is also working through an NIH grant that I will discuss in
more detail later to help better identify the range and occurrence of
these diseases.
Finally, IDF has a very active public policy program that focus on
blood safety issues, patient reimbursement for treatment, and advancing
scientific knowledge regarding primary immune deficiency diseases.
Mr. Chairman, I am both a patient, a physician, and the newly
elected Chairman of the IDF Board of Trustees. My case is
representative of a typical immune deficient patient. I was diagnosed
with Common Variable Immunodeficiency 10 years ago, following years of
repeated infections, which were unresponsive to antibiotics, and
undiagnosed by numerous physicians who happened to be colleagues of
mine. This led to numerous unsuccessful surgeries resulting in
permanent lung and sinus damage. Prior to my diagnosis, a day was
considered successful if I had enough energy to get out of bed.
Following appropriate diagnosis and treatment with IGIV, I was able to
return to my medical practice and developed a new lease on life.
In my testimony, I would like to highlight three areas of
importance to the IDF and the primary immune deficiency community we
represent: (1) National Primary Immune Deficiency Surveillance Program.
(2) Primary Immune Deficiency Research at the National Institutes of
Health. (3) Primary Immune Deficiency Registries at the National
Institute of Allergy and Infectious Diseases.
NATIONAL PRIMARY IMMUNE DEFICIENCY SURVEILLANCE PROGRAM
Mr. Chairman, because primary immune deficient patients are the
only patient population that require life-long infusions of IGIV to
maintain their health, the Immune Deficiency Foundation has been
working to establish a national surveillance study of this group to
evaluate the short and long term effects of IGIV use. The establishment
of this surveillance initiative is vitally important because although
primary immune patients have been treated with IGIV for over 20 years,
a prospective study on adverse events associated with its use has not
been performed.
IDF's surveillance program would provide valuable epidemiological
data on the potential risks of IGIV therapy, and conditions which might
predispose patients to adverse events. In addition, this initiative
would benefit other IGIV users by serving as an early warning system
should study participants be exposed to new and emerging pathogens.
IDF's proposed surveillance study would focus on the following:
--Identifying and characterizing adverse events
--Determining their prevalence and incidence
--Determining whether there are specific risk factors for adverse
events such as: (1) Certain primary immunodeficient diseases
(e.g., Common Variable Immunodeficiency vs. X-Linked
Agammaglobulinemia); (2) Pre-existing medical conditions (e.g.,
renal and/or cardiac disease); and (3) More common with some
preparations than with others (e.g., different brands and
different formulations).
Mr. Chairman, IDF has been working with the plasma fractionation
industry, the Food and Drug Administration, and the Centers for Disease
Control and Prevention to establish this new surveillance program, and
we are grateful for the subcommittee's support of this partnership last
year as we developed the details of this project. Now that the program
is nearing the end of the planning stage, we ask that you continue to
support this important public health initiative by encouraging CDC to
work with us again in fiscal year 2002. Moreover, we ask that you
encourage the National Institutes of Health to support this effort as
well.
primary immune deficiency research at the national institutes of health
Mr. Chairman, I would like to take this opportunity to thank the
subcommittee for its longstanding support of biomedical research at the
National Institutes of Health. IDF remains committed to the goal of the
doubling the NIH budget by fiscal year 2003. Specifically, IDF
encourages the subcommittee to continue its support of primary immune
deficiency research at the National Institute of Allergy and Infectious
Diseases (NIAID), the National Institute of Child Health and Human
Development (NICHD), and the National Cancer Institute (NCI).
In recent years, NIAID sponsored research has shed new light on the
genetics of primary immunodeficiencies. NIAID investigators are using
this information to develop new gene-based therapies for many primary
immune disorders. This cutting-edge research has given patients hope
that improved therapies, and eventually a cure, for these diseases may
be on the horizon. Primary immune deficiency research also benefits
people suffering from other disorders, such as autoimmune diseases and
cancer, due to its acute focus on the functions of the immune system.
Recognizing the promise that biomedical research holds for
improving the quality of life for primary immune deficient patients,
IDF joins with the Ad Hoc Group for Medical Research in recommending a
16.5 percent increase for NIAID, NICHD and NCI in fiscal year 2002.
PRIMARY IMMUNE DEFICIENCY CLINICAL REGISTRIES PROGRAM
Mr. Chairman, since 1997, IDF has contracted with NIAID to
construct and maintain registries of 8 primary immunodeficiency
diseases including, Chronic Granulomatous Disease, Common Variable
Immunodeficiency, DiGeorge Anomaly, Hyper IgM Syndrome, Leukocyte
Adhesion Defect, Severe Combined Immunodeficiency, Wiskott-Aldrich
Syndrome, and X-Linked Agammaglobulinemia. The goal of these registries
is to assemble a comprehensive clinical picture of each disorder,
including estimates of disease prevalence, clinical course, and
complications.
This data is an invaluable resource for physicians conducting basic
research on these disorders. For example, information from one registry
(chronic granulamatous) is being used by four institutions to examine
six different questions relating to various aspects of the disease.
Further expansion of these registries is essential if we are to
increase our understanding of additional primary immune deficiency
disorders. IDF appreciates the subcommittee's longstanding support of
the NIAID/IDF clinical registries partnership and encourages you to
continue to support these important programs in fiscal year 2002.
Mr. Chairman, thank you once again for the opportunity to present
the views of the Immune Deficiency Foundation.
______
Prepared Statement of the Infectious Diseases Society of America's
(IDSA)
IDSA appreciates the opportunity to provide testimony to the Senate
Appropriations Subcommittee on Labor, Health and Human Services, and
Education concerning fiscal year 2002 funding for the Centers for
Disease Control and Prevention (CDC), the National Institutes of Health
(NIH)--particularly the National Institute of Allergy and Infectious
Diseases (NIAID), the Office of AIDS Research (OAR) and the Fogarty
International Center (FIC)--and for the Health Resources Services
Administration (HRSA).
IDSA represents more than 6,000 physicians and scientists devoted
to patient care, education, research, and community health planning in
infectious diseases. Our members share a common focus on the
epidemiology, diagnosis, prevention, investigation and treatment of
infectious diseases. The discipline of infectious diseases is a
subspecialty of both internal medicine and pediatrics, typically
involving a two-to-three year fellowship and then board certification.
Infectious diseases physicians care for patients with serious
infections, including persons with HIV/AIDS, meningitis, heart valve
infections, severe bone, joint or wound infections, and those with
cancer or transplants who have life-threatening infections caused by
unusual organisms. IDSA is the principal organization representing
infectious diseases physicians.
Infectious diseases are the second leading cause of death and the
leading cause of disability-adjusted life years worldwide (one
disability-adjusted life year is one lost year of healthy life) and the
third leading cause of death in the United States. The World Health
Organization estimates that 1,500 people die each hour from an
infectious disease. Diseases, such as AIDS, hepatitis, tuberculosis,
malaria and pneumonia, as well as new and emerging infectious diseases,
continue to cause unfathomable human suffering in this country and
around the world. The real and potential implications on human lives
and the escalating costs of health care in this country is staggering.
CDC reports that should an influenza pandemic occur in the United
States today with the ferocity of past ones, it would cause an
estimated 89,000 to 207,000 deaths, 314,000-734,000 hospitalizations;
and the economic impact would range from $71 billion to $167 billion.
Earlier predictions of the elimination of infectious diseases did
not take into account changes in demographics and human behaviors and
the extraordinary ability of microbes to adapt, evolve, and develop
resistance to drugs. More than 35 newly emerging infectious diseases
were identified between 1973 and 1999, and new infectious disease
threats continue to be identified. The continual evolution of emerging
and reemerging diseases, particularly the acceleration of the HIV/AIDS
pandemic in developing countries, will heighten the global impact of
infectious diseases in this century.
But the story is not all bleak. Advances made over the past century
in infectious diseases treatment, prevention and research, particularly
related to vaccines' development, and infection control have
demonstrated the many benefits that biomedical research and public
health may have in bringing these diseases under control. As the
physicians who care for patients with serious and often life-
threatening infections and as researchers who study drug resistance and
are involved in development of new and better antimicrobial agents, our
goal is to ensure that patients have access to state-of-the-art care
and that the care provided is the most clinically appropriate for each
patient.
We strongly believe that today's investment in infectious diseases
prevention, treatment, and research will pay significant dividends in
the future to the American people in dramatically reduced health care
costs and improved quality of life for millions. As such, the Society
has strongly advocated for appropriate funding for biomedical research,
public health and infrastructure building. And, as infectious diseases
do not recognize nor respect arbitrarily determined national borders,
IDSA also adamantly supports United States' leadership in funding
international collaborative efforts to fight transmission of infectious
diseases through international research and infrastructure building in
lesser-resourced countries.
NATIONAL INSTITUTES OF HEALTH
It is unlikely that we can overestimate the importance that the
National Institutes of Health have had in advancing the continuum of
disease knowledge now available. NIH is largely responsible for
orchestrating current efforts in scientific discovery and for training
future scientific leaders. The National Institutes of Allergy and
Infectious Diseases (NIAID), NIH's Office of AIDS Research (OAR) and
the John E. Fogarty International Center (FIC) are largely responsible
for fulfilling those goals in the field of infectious diseases in the
United States and around the world. NIAID-, OAR- and FIC-sponsored
research and training in the areas of HIV/AIDS, sexually transmitted
diseases, tuberculosis, malaria, new and emerging infectious diseases,
antimicrobial resistance and genomics will significantly and favorable
impact the health of millions of Americans and people of all countries.
We applaud Congress' and the Administration's commitment to
increase support for NIH's programs and to double its budget by 2005.
We can think of no more important investment than for the basic and
clinical research that NIAID, OAR and FIC sponsors and conducts. We
would note that, although the FIC's budget has increased substantially
over the past several years reaching $50 million in fiscal year 2001,
this amount is a small fraction of what is necessary to carry out the
increasingly important international research and training that FIC
supports around the world. Thus, we recommend that you closely review
FIC's budget with an eye toward providing a significant increase in
funding for the Center in fiscal year 2002.
CENTERS FOR DISEASE CONTROL AND PREVENTION
CDC is the nation's prevention agency. Its important mission is to
translate health information, including the results of NIH-sponsored
research, into prevention programs that are effective in the diversity
of our nation's communities. They do their work in partnership with
state and local public health providers and other Federal agencies. CDC
programs make public health work around the nation.
Increased surveillance and response, applied research,
infrastructure building and training and prevention and control efforts
are all necessary if we are to meet the challenges that infectious
diseases will create in the years to come. CDC's Strategic Plan
Preventing Emerging Infectious Diseases: A Strategy for the 21st
Century continues to build domestic and global capacity for recognizing
and responding to infectious diseases. Providing health departments
with resources for building epidemiology and laboratory capacity has
dramatically improved our ability to identify, investigate, and rapidly
implement control measures in outbreak situations (such as with West
Nile in the eastern United States and E.Coli, Salmonella and Listeria
in other parts of the country).
Both NIH and CDC's work are inextricably linked. And, while we
strongly support the Administration's proposed funding for NIH, we
maintain that Congress' and the Administration's commitment to CDC must
not waiver. Increased funding for NIH must not be appropriated at the
expense of CDC and/or other public health programs. Thus, we support
increased funding to enable CDC to implement the activities envisioned
in its Strategic Plan. It is our best professional judgment, given the
many unmet public health needs and missed prevention opportunities,
that CDC funding should be increased to $5 billion, a $1.2 billion
increase over fiscal year 2001 levels, to permit the agency to
adequately fulfill its mission.
Moreover, the ever-evolving complexity of CDC's budget structure
and the increased practice by Congress to dedicate particular funds for
specific projects is a cause of great concern to the public health
community and fiscal planners. A Pricewaterhouse/Coopers study has
determined that CDC's budget structure is particularly inflexible and
that this may have negative implications for public health. The General
Accounting Office has concurred with these findings. We ask that
Congress review this analysis and act accordingly to afford CDC the
flexibility to effectively and efficiently carry out its public health
mission.
HEALTH RESOURCES AND SERVICES ADMINISTRATION
Programs administered through the Health Resources and Services
Administration serve as vital components of the nation's health care
safety net. From funding for health professionals' training to
resources for community health centers and HIV/AIDS services, HRSA
funding provides vital resources that translate into health care for
underserved and disenfranchised populations. Of particular interest to
IDSA is funding for the Ryan White CARE Act, a program that funds
medical care, drug therapy for HIV disease and HIV-related
opportunistic infections, and ancillary services for uninsured and
underinsured individuals, as well as training for health care
providers. IDSA urges the Subcommittee to support generous funding for
all Titles of the Ryan White Care Act so that biomedical and clinical
research may benefit all Americans living with HIV disease.
SIGNIFICANT FUNDING NEEDS EXIST
Now, we would like to highlight a few specific public health and
research areas where increased funding is needed.
Antimicrobial resistance
In the United States and around the world, many important human
infections are becoming increasingly resistant to the antimicrobial
drugs used to treat them. For example, CDC reports that in some areas
of the United States, more than 30 percent of infections with
pneumococci, the most common cause of bacterial pneumonia and
meningitis, are no longer susceptible to penicillin. In the 1970s, all
were susceptible. Moreover, nearly 30 percent of the bacteria that most
frequently cause infections acquired in hospital intensive care units
are resistant to the preferred antibiotic.
We must respond to the persistent problem of antimicrobial
resistance by increasing research efforts, creating surveillance
systems and developing strategies to ensure that newly developed and
existing drugs are used effectively. An interagency task force, co-
chaired by CDC, the Food and Drug Administration and NIH recently
released ``A Public Health Action Plan to Combat Antimicrobial
Resistance''. The Plan outlines a number of surveillance, prevention
and control, research, and product development action items. Increased
funding is necessary to permit these agencies to move quickly to
implement these critical action items. We also support full funding to
implement the Public Health Improvement Act that was enacted last year.
Food safety
According to CDC, food-borne diseases cause approximately 76
million illnesses, 325,000 hospitalizations, and 5,000 deaths in the
United States each year. Hospital costs for these illnesses are
estimated at more than $3 billion per year. Costs from lost
productivity are estimated at $8 billion per year.
Through the National Food Safety Initiative, Congress has supported
increased funding over the past several years, which has enabled the
Department of Health and Human Services (HHS) and U.S. Department of
Agriculture (USDA) to move aggressively to reduce the impact of food-
borne illness in this country. CDC, USDA, and FDA have developed and
implemented critical, new research, surveillance, education and
prevention efforts, under this initiative. We encourage Congress to
continue to lead the way in this effort by increasing funding for the
Food Safety Initiative.
Bioterrorism
The nation's public health infrastructure is not adequate to detect
and respond to a bioterrorism event in this country. The potential for
such an event increases with each passing day. Timely response to a
bioterrorism event will absolutely depend upon a sound monitoring
system at the community level. Such a system will require strong
support for state and local public health infrastructure, particularly
adequately equipped and staffed laboratories, and support as well for a
program that cuts across all centers and programs at CDC. To this end,
increased funding is needed to implement the activities authorized last
year through the Public Health Improvement Act. Only through sufficient
funding for assessments of local capacities to respond to an event,
infrastructure development and training, vaccine research and
development at NIH and coordinated response efforts across governments
and health care organizations will we be able to anticipate problems,
prioritize resources, and intervene effectively.
Vaccines and immunization
Immunizations are among the greatest public health achievements of
the 20th Century. With the advent of vaccines for chickenpox, measles,
whooping cough, polio, pneumococcal disease, hepatitis B, influenza and
other infectious diseases, thousands of lives have been saved and
disability and suffering averted with incredible cost savings achieved.
Despite generally high coverage levels in the United States, pockets of
under-immunized children, adolescents and adults remain at increased
risk for contracting and transmitting vaccine preventable diseases. The
global picture is much more ominous.
Additional funding is needed to shore up the nation's immunization
infrastructure. In an Institute of Medicine report released last year,
entitled Calling the Shots, experts agreed that unstable funding for
state immunization programs threatens coverage for specific populations
and age groups. In addition, according to CDC, immunization costs for
more than 12 million Americans are not covered by public or private
health insurance programs. This is shocking given the level of
importance to public health and the demonstrated cost-effectiveness
that have been realized as a result of the establishment of the
National Immunization Program (NIP). Increased funding is critical to
ensure that every individual may have access to appropriate vaccines.
Sufficient funding for CDC's programs to eliminate measles in the
Western Hemisphere and to eradicate polio worldwide also is critical.
The benefits of these programs are not limited to other countries; in
the United States alone, the eradication of polio would result in a
yearly cost savings of $230 million.
Finally, new vaccines' research and development will help us to
prevent populations from becoming infected in the first place.
Researchers at NIAID are working to develop vaccines for tuberculosis,
HIV and Streptococcus pneumoniae, the leading cause of morbidity and
mortality in infants and young children worldwide. NIH-sponsored
research has proven successful in the past, most notably with the
development of vaccines against Haemophilus influenzae type b (Hib) a
bacterium that can lead to life-threatening meningitis and pneumonia in
young children. Thanks to the work of NIH researchers, this vaccine
reduced the number of cases of invasive Hib disease by 97 percent from
1987 to 1997. In order to repeat this success with other diseases, we
urge your continued support for vaccine research and development.
HIV/AIDS
A comprehensive funding strategy through NIH's Office of AIDS
Research, CDC's prevention programs and HRSA's primary care services is
the only appropriate response to the HIV/AIDS epidemic. Increased
funding for AIDS through the Office of AIDS Research is critical.
Through the research that it supports, the Office of AIDS Research
holds the most promise for saving and improving many lives through the
development of improved treatments for people living with HIV/AIDS and
the development of an HIV/AIDS vaccine. CDC plays a key role in the
fight against the spread of HIV/AIDS. With 40,000 new cases of HIV
being diagnosed each year, this is no time for complacency. We strongly
encourage increased investment in CDC's HIV/AIDS programs. These
include the HIV/AIDS surveillance program that tracks the disease and
informs the development of national and local prevention efforts;
funding of community-based programs that design and implement
prevention programs targeted at their communities; and the variety of
programs funded through the Congressional Black Caucus (CBC). The CBC
programs deserve special attention given the alarming increase of HIV/
AIDS in minority communities. To adequately support these and other
important programs, CDC funding for HIV/AIDS programs should be
increased substantially. The Ryan White CARE Act administered under
HRSA is the heart of the federal response to HIV/AIDS care. Generous
funding for all titles of the CARE Act are necessary to maintain the
significant reductions in HIV-related morbidity and mortality we have
enjoyed in recent years.
Finally, IDSA strongly supports HHS' global AIDS efforts.
Substantial increases are warranted for new research, treatment and
prevention strategies, and public health infrastructure building in
lesser-resourced countries. Our Society supports a robust and
comprehensive U.S. response to the global HIV/AIDS pandemic. We will be
advocating for increased funding in other federal budget accounts as
well.
Thank you again for the opportunity to provide IDSA's views on
these important matters to the subcommittee. Please let us know if you
require any additional information.
______
Prepared Statement of the Joslin Diabetes Center
Mr. Chairman and Members of the Subcommittee, I appreciate the
opportunity to appear before you to present Joslin Diabetes Center's
proposal to improve the access to and quality of health care for people
with obesity and type 2 diabetes and to reduce costs and increase
savings for these health care outlays by establishing a new paradigm
for the prevention and treatment of obesity and type 2 diabetes.
Obesity is a major risk factor for the development of type 2
diabetes and insulin resistance and a major cause of morbidity and
mortality in the Unites States:
--1 in every 2 Americans is overweight and the prevalence of obesity
has increased 57 percent in the last 10 years.
--Obesity disproportionately affects minorities--60 percent of
African-American, Mexican-American, and Native-American women
meet the criteria for being overweight and between 33-37
percent are obese.
--Obesity in children and adolescents is increasing at an alarming
rate, leading to the occurrence of type 2 diabetes in these
groups.
Equally foreboding for the future well-being of our country, the
startling rise in obesity is driving an emerging epidemic of diabetes
in the United States:
--Diabetes in the United States increased by 6 percent in 1999.
--Over 90 percent of diabetes is type 2 (adult-onset), and 90 percent
of people with type 2 are obese.
--The Centers for Disease Control and Prevention reported that
diabetes increased 33 percent nationally to 6.5 percent between
1990 and 1998.
--The rise in diabetes costs increased across all age groups but was
most profound--about 70 percent--among people ages 30-39.
-- For the rapidly expanding over-50 age group, the incidence of
diabetes approaches 20 percent, and diabetes and its
complications comprise 25 percent of Medicare costs.
Obesity is a risk factor for:
--Diabetes
--Cardiovascular disease--heart attack, stroke
--High blood pressure
--Sleep apnea
--Uterine cancer
--Breast cancer
--Colon cancer
--Gall bladder disease
With over 50 percent of the population obese, these risk factors
underscore why this serious problem is emerging as an epidemic.
As the world's largest and most comprehensive independent diabetes
research and patient care institution, Joslin Diabetes Center proposes
the development of a pilot program to prevent and treat obesity and
type 2 diabetes. Over 80 percent of people with type 2 diabetes would
be ``cured'' if they could lose 10-20 pounds of weight. Unfortunately,
90 percent of these people with type 2 diabetes cannot successfully
lose weight because obesity is a medical problem and not a moral fault.
To address the growing epidemic of obesity and type 2 diabetes,
Joslin Diabetes Center would like to share technology, methods and
experience through the development of a pilot demonstration project for
the prevention and treatment of obesity and type 2 diabetes:
--To adapt Joslin's state-of-the-art Diabetes Outpatient Intensive
Treatment Program for different ethnic, economic, social and
age population groups.
--To demonstrate the effective long-term benefits of Joslin's
Intensive Treatment and telemedicine protocols.
--To evaluate clinical strategies for prevention and treatment of
obesity including the application of our growing knowledge of
molecular mechanisms that increase appetite and of the role of
leptin in obesity.
--To analyze different diets of people with type 2 diabetes.
--To advance Joslin's applied research results in the development of
preferences for alternative food choices and lifestyles and
community-level and school interventions to prevent obesity and
the onset of diabetes.
Joslin's pilot project would demonstrate significantly improved
prevention and treatment of obesity and type 2 diabetes, resulting in
reduced costs, improved patient access and quality of life.
Specifically, we propose to initiate a pilot project of detection,
prevention, and care of obesity and type 2 diabetes for a three-year
period, utilizing training and validation exercises derived from
Joslin's expertise and telemedicine infrastructure. The cost would be
$3.6 million annually.
Through its Diabetes Outpatient Intensive Treatment Program, Joslin
applies a new approach towards patients with diabetes. This approach
focuses on two major areas: improving clinical outcomes in a practical,
resource-efficient manner. Clinical outcomes have demonstrated improved
metabolic control (and thus fewer long-term complications) and reduced
patient stress resulting from having to treat their diabetes. The
Program is focused on individual flexibility and was developed in a way
to be more efficient in utilization of both patient resources and
health-care resources.
Rather than rely on continued intensive involvement of health care
providers throughout a patient's lifetime, we put the patient through a
short, intensive course of training which not only leads to an
immediate improvement in their metabolic control, but gives the patient
the foundation to take care of themselves in the future. The Program
also reduces the patient's diabetes-related stress by training the
patients to care for their own diabetes, seeking other professional
input when needed. This is more appealing to the patient, more
efficient in the use of resources in the long-term, and produces good
results.
With the proposed pilot project, Joslin is in the process of
developing an alternative Outpatient Intensive Treatment Program for
people with obesity and type 2 diabetes. The pilot project will
establish and validate appropriate criteria, protocols and outcome
guidelines for different ethnic, economic, social and age population
groups.
Utilizing Joslin's JVN telemedicine infrastructure, Joslin Diabetes
Center will design and develop a modularized medical outcomes-based
Telemedicine Diabetes Intensive Treatment Program to provide a web-
based Comprehensive Diabetes Management System. Integrating Joslin's
JVN telemedicine infrastructure as a component of the CDC can link
health care practitioners with the National Diabetes Education Program,
targeting the segment of the population that suffers from the epidemic
explosion of obesity and diabetes complications. Adaptation of Joslin's
JVN system for treating obesity and type 2 diabetes can measurably
improve patient access, compliance, education and motivation to further
increase effective long-term individual and society health benefits.
Ongoing research at Joslin addresses how complex molecular
mechanisms regulate body weight (hormones that control eating and
appetite), how the fat cell functions as an endocrine cell, how leptin
signaling the brain affects eating, and how fat interacts with the beta
cell to cause diabetes. Resulting new clinical strategies for
prevention and treatment of obesity and diabetes complications will be
incorporated as a component of the pilot project.
The three-year demonstration pilot will additionally provide the
opportunity to broaden the clinical applications of promising bariatric
surgery and medical therapy protocols for alleviating obesity and
resulting diabetes complications. Evaluation of strategies for the
prevention and treatment of obesity and type 2 diabetes will analyze
long-term effects of gastric by-pass (bariatric) surgery, including
clinical evaluation of people with gastric bypass surgery and the
clinical evaluation of medical therapies to further refine Joslin's new
paradigm of intensive treatment of obesity and type 2 diabetes.
The demonstration project will train health care providers, e.g.
nurse educators and physicians, from and for different ethnic,
economic, social and age population groups. Concurrently, Joslin will
provide curriculum-based patient and provider education modules.
The proposed pilot project will demonstrate significantly improved
detection, prevention and care techniques for obesity and type 2
diabetes, resulting in overall reduced costs, improved patient access,
and improved quality of life. Furthermore, this demonstration of
Joslin's new paradigm for obesity and type 2 diabetes health care will
provide better clinical understanding and expertise, which can be
effectively extended to benefit all people living with type 2 diabetes.
Thank you for this opportunity to appear before you today. I would
be pleased to answer any questions you might have.
______
Prepared Statement of the Juvenile Diabetes Research Foundation
International
Brayton James DiPietro
Before I begin, I would like to thank the Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and Related
Agencies for giving me the opportunity to share my story. My name is
Brayton DiPietro and I am pleased to testify on behalf of the Juvenile
Diabetes Research Foundation. I am in the eighth grade at St. Paul's
Grade School in North Canton, Ohio. I also have diabetes and was
diagnosed just after my eleventh birthday. I will be fifteen this June,
so this summer will mark four years that I have had the disease.
I broke my leg on December 15 while sledding in my backyard. The
doctors were unable to use any rods or pins in setting my break because
people with diabetes run a high risk of infection. We also heal slower.
For a person with diabetes, the entire process would have taken about
one fourth as long.
Many people believe that the life of an individual with diabetes
doesn't change dramatically once diagnosed. I am here to tell you that
that is not true. Three or four times a day, I have to check my blood
sugar by pricking my finger and give myself an injection of insulin. I
have to think about every single thing that I eat and when I eat it. As
a teenager, it won't surprise you that I would love to sleep in on a
Saturday morning. However, if I do that it would throw of my blood
sugar levels and it could take several days to get back on course.
Those, of course, are the good days. When I have the flu, I have to
check my blood sugar constantly and my urine for ketones to make sure
that I don't go into Ketoacidosis, a condition that could be fatal in
less than 24 hours. When I play baseball, I have to check my blood
sugar level every other inning to make sure I am maintaining proper
blood sugar levels. Even taking these precautions, I have experienced
loss of vision, dizziness, and general disorientation during a game.
I don't really know what I am going to be yet when I grow up. I
know that I can't be a pilot for the Navy because of my diabetes. Can
you imagine what would happen if I blacked out in a combat situation?
I have approximately 6,000 finger pricks plus an equal amount of
insulin injections in the past four years. That doesn't even count
regular drawing of blood tests at the doctor's office. While I wait for
a cure, which I know will happen if you continue to generously support
medical research at the National Health Institute and help ensure that
juvenile diabetes research is adequately funded, the best thing that I
can do is to continue to take proper care of myself, remain
disciplined, and try to lead as normal a life as possible.
Back in Canton, I heard a lot about the not so good things that
happen in Washington these days. I am really glad to have the
opportunity to be part of a good thing that is happening in Washington.
Your subcommittee's leadership in doubling the NIH budget by 2003 could
allow me to live a fuller and healthier life. Thank you.
Steven DiPietro
Brayton's story is not unique. In one form or another, it is shared
by each of the 16 million Americans who have diabetes. In addition to
its personal burden, diabetes carries an extraordinary price tag--one
in four Medicare dollars are attributable to individuals with diabetes,
and the disease costs our nation more than $100 billion annually. If we
could cure diabetes it could both solve the Medicare solvency problem
and be a major boost to our economy!
As you may imagine, I am very proud of my son, who I witness each
day persevere through his daunting, daily regimen of living with
diabetes. I do my share in fighting juvenile diabetes by volunteering
with my local chapter of the Juvenile Diabetes Research Foundation,
where I currently serve as Board President. I am pleased that through
our local walks, galas, and special events, JDRF will be able this year
to allocate $120 million for juvenile diabetes research.
However, we can't do it alone. This is why your continued support
for the bipartisan effort to double the NIH budget over five years and
provide the NIH with a $3.4 billion increase in funding this year is
critical to individuals with diabetes.
Last year, researchers announced that seven individuals with
diabetes had been ``cured'' of the disease following the successful
transplantation of insulin-producing cells. In my mind, the question is
no longer whether we will cure diabetes, but when will it happen. Your
support for doubling the NIH budget will make this happen sooner, and
my family, and the millions of others who have diabetes want to thank
you for making their hopes and dreams possible.
______
Prepared Statement of the Kennedy Krieger Institute
Mr. Chairman, Members of the Committee, the Kennedy Krieger
Institute in Baltimore, Maryland appreciates the opportunity to present
its views on a number of important programs supported by the U.S.
Department of Education; the National Institutes of Health and the
Health Resources and Services Administration at the U.S. Department of
Health and Human Services.
We would like to highlight the efforts of three federal agencies
under your jurisdiction and the important work that they do to
strengthen the capacity of programs, such as the Kennedy Krieger
Institute, to make progress in the important areas of education and
health.
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. Although
the Institute has special expertise with regard to children, the
research scope includes studies of changes in the brain and the central
nervous system across the lifespan. The Kennedy Krieger Institute is a
comprehensive resource for children with disabilities, recognized as a
research facility and training center for health care professionals
from around the world. The Institute treats a wide array of children
with neurological diseases including, but not limited to, Down
syndrome; attention deficit hyperactivity disorder; lead poisoning,
autism; cerebral palsy; genetic and metabolic disorders, like fragile X
syndrome, neurofibromatosis, tay sachs disease, tourette syndrome;
spina bifida; degenerative brain disorders; mental retardation; and
many others. Our Institute integrates cutting edge neurobiological and
behavioral 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.
BASIC AND CLINICAL RESEARCH
The Board of Directors, the researchers, health professionals and
patients and families at the Kennedy Krieger Institute are all very
grateful for the support that this Committee has provided to the NIH
over the past several years. The resources that Congress has
appropriated have enabled the research community to grasp research
opportunities that a decade ago we could not even have dreamed
possible. This is making an incredible difference in the lives of the
children that we treat.
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, behavioral, and other research.
The Kennedy Krieger Institute receives funding from the NCRR for our
neurobehavior research unit through a subcontract from the Johns
Hopkins University General Clinical Research Center (GCRC). The support
we receive is used to conduct studies related to functional imaging. We
believe it is important for the Committee to consider an NIH National
Imaging Network for Clinical Research that 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.
Clearly, multiple programs supported by the National Institutes of
Health (NIH) enrich our capacity to address important basic and
clinical research issues in the population that we serve. The work of
this Committee ensuring a sustained commitment to these programs has
enabled institutions, such as ours, to move forward at unprecedented
speed. To that end, we urge the Committee to continue its efforts in
support of the NIH.
Request.--The Kennedy Krieger Institute endorses the recommendation
of the Ad Hoc Group for Medical Research Funding for fiscal year 2002
which recommends a $3.4 billion, or 16.5 percent, increase that will
result in a total NIH budget of $23.7 billion in fiscal year 2002. This
funding level is necessary to continue the congressional campaign 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 Kennedy Krieger Institute's Lower and Middle Schools,
recipients of the US 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.
Employment data for all youth in the United States are a national
concern. Fewer students are graduating from high school adequately
prepared to enter post-secondary program or secure competitive
employment. Of particular concern are youth with disabilities, who are
consistently less successful than their non-disabled peers. It has been
estimated that 70 percent of individuals with disabilities are either
unemployed or underemployed.
The Kennedy Krieger high school program, which opened in September,
1999, provides a comprehensive approach to school-to-work transition
for youth with serious learning, emotional, neurological, and
developmental disabilities. The school-to-work curriculum at our Career
and Technology High School is unique in that it will be the only
program in the state to make career training the foundation of, and not
merely a supplement to, the school's core curriculum. All of the
students that attend the Kennedy Krieger Career and Technology High
School demonstrate a serious disability, and 50 percent of these
students come from families supported by federally-funded programs for
children and families living below the poverty level. As the school's
student population grows from the current enrollment of 125 to 200
students, it is anticipated that the percentage of students living
below poverty will remain current if not increase.
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 who have the potential to undertake meaningful employment.
Students will graduate with the knowledge and work and social
experience they will need for successful postsecondary 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 Education, including 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 strong support.
Request.--The Kennedy Krieger Institute respectfully requests $2
million in program funding from the Department of Education's
Technology Innovation Challenge Grant program to support the expansion
of a dynamic performance-based curricula and instructional delivery
options utilizing distance learning that connects educational and
research programs. Students, teachers, parents, and other professionals
will receive support through instructional software, performance
databases, access to the Internet, and opportunities for self-directed
learning.
MARCUS INSTITUTE, ATLANTA GEORGIA
The Kennedy Krieger Institute has embarked upon a collaboration and
formal fiscal affiliation with the Marcus Institute, located in
Atlanta, Georgia, to establish a national network of developmental
services for children with disorders of the brain and their families.
The foremost goal of this national initiative is to rally support and
spearhead unified advocacy for individuals with developmental
disabilities and severe and challenging behaviors so that they can
experience a greater quality of life and participate as fully as
possible in family, school, and community life.
Currently, the Marcus Institute is housed in leased space within a
professional office park--a location woefully inadequate for the
programs and specialized services provided to the severely disabled
children served by the Institute. We are in the process of developing
an 80,000 square foot facility near the Emory University campus and the
Centers for Disease Control and Prevention. The new facility will allow
the Institute to expand upon its mission to encourage and facilitate
advanced research, training, and programming for children and
adolescents with developmental disabilities and severe and challenging
behaviors through the further refinement and expansion of the Marcus
Behavior Center. This behavior center of excellence is devoted to
providing the most advanced clinical treatments, training, and research
so that services for the families of children with severe and
challenging behavior are as effective and as comprehensive as possible.
The new Marcus Institute will include a school with a student
population of approximately 50 children. The school will work with
those children with the most acute emotional, behavioral, and
psychological challenges to continue their educational process while
receiving our specialized services and avoid additional difficulties
when they return to their community school. The Marcus Institute school
is designed continue their education while they are here, rather than
permanently removing them from their community school.
Since 1993, the Marcus Institute has provided clinical services to
more than 14,000 individuals, conducted research, and provided
education and training programs. These services have been provided by
developmental pediatricians, psychiatrists, behavioral, clinical and
neuro-psychologists, neurologists, geneticists, nurses, physical,
occupational, and speech therapists, social workers, special educators,
and family support personnel.
The Marcus Institute in Atlanta and Kennedy Krieger Institute (KKI)
in Baltimore have developed a partnership in which programmatic,
research, and training expertise is shared to provide community-based
treatments for children with developmental disabilities who display the
most severe forms of behavior disorders, including aggression, self-
injurious behavior, and pediatric feeding disorders. These behaviors
pose a substantial risk to the individual(s), family members, and other
care providers. Without appropriate treatment, these children are at
substantial risk for health problems (and even death) and for lifelong
placement in residential programs, which often costs $100,000 or more
per year and millions of dollars over the individual's lifetime. The
behavior programs at the KKI have been in existence for over 20 years.
All children who receive these services show clear improvement and over
80 percent meet their primary discharge goals (compared with less than
2 percent for traditional outpatient mental health services).
The Marcus and Kennedy Krieger programs are unique not only in
terms of their success levels, but also because the effectiveness of
the treatment protocols used have been documented through systematic
program evaluation data and through formal research studies published
in refereed journals. The Marcus Behavior Center currently provides a
continuum of consultative, outpatient, educational, and day treatment
services for children with severe behavior disorders. Those with the
most severe problems are seen in our intensive day treatment programs.
Young children (usually below age 6) are admitted to the Feeding Day
Treatment Program if they display behaviors such as food refusal or
food selectivity (eating one or only a few foods) that necessitate
medical interventions (e.g., gastrostomy tubes) to prevent malnutrition
or death. School-aged children (ages 3 to 21) are admitted to the
Severe Behavior Day Treatment Program if they have developmental
disabilities and display severe self-injurious behavior (SIB),
aggression, or property destruction that poses a significant risk to
self, others, or the environment, which cannot be safely managed or
effectively treated in a less intensive program.
Less severe cases are served through our outpatient and
consultative programs, whereas the most severe cases are served through
our day treatment programs. For example, SIB consists of repetitive
motor responses that produce physical harm to the individual who
displays the behavior. Typical forms of SIB include head banging, self-
biting, head hitting, body hitting, scratching, eye poking, pica, and
ear poking. SIB is extremely rare among individuals of normal
intellectual functioning. It is seen in approximately 6 percent to 16
percent of individuals with mental retardation and autism.
As part of our collaborative effort, the Kennedy Krieger Institute
is working with the Marcus Institute, the United States Congress, and
State and local officials in Georgia as we establish this state-of-the-
art facility in Atlanta.
Request.--We respectfully request $5 million in fiscal year 2002
funding through the Health Resources and Services Administration (HRSA)
Construction account to provide assistance with the construction of a
new, state-of-the-art health facility for the Marcus Institute. The
Marcus Institute was created as a result of a generous donation by
Bernie and Billie Marcus. It is known as a nationally recognized center
for excellence for the provision of coordinated and comprehensive
services for children and adolescents with developmental disabilities
and severe and challenging behaviors. Our goal is to publicize any
Federal grant to leverage additional dollars throughout the private
sector. Funding at the $5 million level would provide 20 percent of the
total cost of the campus.
CONCLUSION
The Kennedy Krieger respectfully requests the support of the
Committee through the allocation of fiscal year 2002 funds for the
following.
1. A continued commitment to the congressional campaign to double
the NIH budget by 2003 by providing a $3.4 billion, or 16.5 percent,
increase for NIH in fiscal year 2002, as advocated by the Ad Hoc Group
for Biomedical Research funding. The continued investment in NIH will
support a number of important research initiatives including brain
biology, neurobehavioral assessment, and molecular sciences to further
understand the molecular basis of many developmental disabilities.
2. The Kennedy Krieger Institute respectfully requests $2 million
in program funding from the Department of Education's Technology
Innovation Challenge Grant program to support the expansion of a
dynamic performance-based curricula and instructional delivery options
utilizing distance learning that connect experiences between school and
the workplace. This investment will permit severely disabled students
to receive support through instructional software, performance
databases, access to the Internet, and opportunities for self-directed
learning.
3. We respectfully request $5 million through the Health Resources
and Services Administration (HRSA) Construction account to provide
assistance with the construction of a new, state-of-the-art health
facility for the Marcus Institute in Atlanta Georgia. It is known as a
nationally recognized center for excellence for the provision of
coordinated and comprehensive services for children and adolescents
with developmental disabilities and severe and challenging behaviors.
The Kennedy Krieger Institute thanks you for the opportunity to
present our views.
______
Prepared Statement of the Drug and Alcohol Service Providers
Organization of Pennsylvania
My name is Deb Beck and I am the President of the Drug and Alcohol
Service Providers Organization of Pennsylvania (DASPOP), a statewide
coalition of drug and alcohol prevention and treatment programs,
practitioners, employee assistance programs, and drug and alcohol
associations representing more than 365 organizations, programs and
clinics, over 3,000 certified addiction professionals, 1,200 student
assistance professionals, and 400 prevention specialists. Thank you for
this opportunity to submit testimony in support of increased fiscal
year 2002 funding for alcohol and drug treatment, prevention, and
research programs in the Departments of Health and Human Services and
Education.
Today I am representing the views of DASPOP, the State Associations
of Addiction Services, which is composed of 27 state-based associations
of treatment and prevention providers in 26 states, and the Legal
Action Center, a non-profit law and policy firm that represents
individuals in recovery from and struggling with alcohol and drug
problems and AIDS.
Thank you, Mr. Chairman and members of the subcommittee, for last
year's increases for alcohol and drug treatment, prevention, and
research programs and your refusal to cut funding for these services.
Funding is even more important in light of the recent sharp increases
in ecstasy use among our youth and in marijuana use among young adults
age 18 to 25. President Bush has recognized the need for expansion of
these services through his campaign proposals for large increases in
funding and his encouragement of even greater participation by faith-
based organizations that meet appropriate standards. We urge the
Congress to dramatically expand funding for the full continuum of drug
and alcohol treatment, prevention, and effectiveness. Providing strong
support for alcohol and drug treatment, prevention, and research is
essential to maintaining and improving the health and well being of our
nation. These programs save lives and money by decreasing alcohol and
drug use, crime, health care costs, AIDS and welfare dependence, and by
increasing employment.
TREATMENT AND PREVENTION NEEDS IN PENNSYLVANIA
Pennsylvania programs have been leaders in developing effective
alcohol and drug treatment programs for women, youth, criminal justice
offenders, and other under-served populations. However, despite the
success of these programs, we are faced with a capacity crisis that
needs attention. The annual waiting list for alcohol and drug treatment
services in Pennsylvania is approximately 49,000 individuals, yet these
individuals represent only a small portion of the actual number of
persons in need of treatment services. And in spite of last year's
increases for the Substance Abuse Prevention and Treatment (SAPT) Block
Grant, this year in Pennsylvania we are expecting that waiting list to
continue to grow as pressure on public treatment funds increases. Some
factors that place a strain on these funds include:
--Reduced Medicaid Coverage.--Many individuals with alcohol and drug
problems have lost their Medicaid coverage which helped to pay
for their alcohol and drug treatment. Some individuals lost
their coverage due to changes in Pennsylvania law, while others
lost Medicaid coverage because of changes in federal law which
made individuals with a primary diagnosis of alcoholism or drug
dependence ineligible for SSI and Medicaid. These changes in
eligibility have created a funding shortfall of more than $80
million.
--Reduced General Support Funding.--Fewer individuals are eligible
for Medicaid coverage that pays for general health care
services. When individuals without Medicaid enter alcohol and
drug treatment and require medical care, alcohol and drug
treatment programs pay for the cost of the client's medical
care by using general support funds that are not specifically
earmarked for alcohol and drug treatment. This reduction in
general support funding results in programs relying more
heavily on funds dedicated expressly to treatment to provide
alcohol and drug treatment services. These dedicated funds
include the SAPT Block Grant.
--Lack of Managed Care Coverage.--Commercial managed care companies
frequently deny coverage for alcohol and drug treatment,
forcing individuals and families to seek treatment in the
publicly funded alcohol and drug treatment system.
--Increase in Purity of Heroin and Cocaine.--In the last few years
heroin has returned to popularity due in large part to the
increased purity of the substance. This allows drug users that
were fearful of injecting chemicals into their bodies to either
smoke or snort the drug. In the past, the average purity of
heroin was between 1 and 10 percent. Now authorities are
noticing the percentage as high as 98 percent in Pennsylvania
compared to a national average of 35 percent. There has also
been a significant increase in the purity of cocaine, the most
commonly used drug in Pennsylvania, with an average purity as
high as 80 to 90 percent. The substantial increase in the
purity of these drugs has put a severe strain on the public
drug treatment system, as users of these purer drugs are more
likely to quickly become addicts in need of treatment.
This increase in demand for treatment services, coupled with
funding and benefit reductions, places even more pressure on the SAPT
Block Grant to provide support for alcohol and drug treatment services.
Increased fiscal year 2002 funding, especially for the SAPT Block
Grant, is necessary in order for Pennsylvania to expand access to
alcohol and drug treatment services, which save both lives and money.
Pennsylvania also has developed effective community-based
prevention services that reduce the onset of alcohol and drug use among
youth and other vulnerable populations. However, decreasing Safe and
Drug Free Schools State Grants program funding will adversely impact
many of these programs, requiring cuts in prevention services for
youth. Increasing funding for effective, community-based alcohol and
drug prevention programs is critical, especially in light of the recent
sharp increases in drug use among middle-school youth. The State Grants
program in the Safe and Drug Free Schools and Communities Act is a
vital resource for these services.
RECOMMENDATIONS
For providers to supply these essential services in Pennsylvania
and throughout the nation, we need your support. We urge Congress to
adopt the following increases in fiscal year 2002 funding for alcohol
and drug treatment, prevention, and research programs in the Substance
Abuse and Mental Health Services Administration (SAMHSA), Department of
Education, and National Institutes of Health. These are wise
investments that will provide desperately needed services in
communities across the country:
--$2.0 billion for the Substance Abuse Prevention and Treatment Block
Grant to continue closing the treatment and prevention gap.
--$350 million for the Center for Substance Abuse Treatment (CSAT)
and $350 million for the Center for Substance Abuse Prevention
(CSAP), including CSAP's High Risk Youth program, to expand
Targeted Capacity Expansion programs that provide targeted, gap
filling services and infrastructure tailored to address
specific and emerging drug epidemics and/or underserved
populations, and to support the continued translation of
research into best practice through Knowledge Development and
Application programs.
--$694 million for the Safe and Drug Free Schools and Communities Act
program, with the increased funding ($50 million) allocated to
the State Grants program to support local, community-based
prevention initiatives.
--$341 million for research at the National Institute on Alcohol
Abuse and Alcoholism (NIAAA) and $991 million for research at
the National Institute on Drug Abuse (NIDA).
TREATMENT AND PREVENTION REDUCE ALCOHOL AND DRUG USE AND HAVE PUBLIC
SUPPORT
Numerous studies have demonstrated the effectiveness of treatment
and prevention in reducing alcohol and drug use. As stated above, the
National Treatment Improvement Evaluation Study (NTIES) evaluated
CSAT's demonstration programs and found sustained reductions in drug
use. Drug use declined by 51 percent for crack, 55 percent for cocaine,
47 percent for heroin, and 50 percent for marijuana for the 5,700
clients studied one year after completing treatment. NTIES also found a
78 percent decrease in violent crime, 19 percent increase in
employment, and 11 percent decrease in welfare dependence. Prevention
has also been shown to be effective in reducing use. A recent study,
conducted by the University of Washington's Washington Kids Count
project, clearly demonstrates that the level of peer substance use in
middle schools has a substantial impact on the academic performance of
students across the state. The study found that on average, students
whose peers had little or no involvement with drinking or drugs scored
18 points higher in the reading portion of the Washington Assessment of
Student Learning (WASL) test and 45 points higher on the math section.
Prevention and treatment have been repeatedly shown to be cost-
effective. The Office of National Drug Control Policy estimates that
drug abuse and addiction cost this country at least $277 billion per
year in deaths, medical emergencies, spread of infectious diseases,
crime, homelessness, lost productivity, and other social costs.
Expanded access to treatment and prevention would decrease this cost. A
1994 California study found that each $1 invested in drug and alcohol
treatment and prevention saves taxpayers $7. These reductions in
taxpayer costs were attributed to savings in criminal justice costs (22
percent), victim losses (40 percent), theft losses (69 percent), and
health care costs (23 percent).
The public recognizes the value of treatment and prevention
services. A 2000 survey found that 84 percent of poll respondents
believed that at least half of the funding available to fight the drug
problem in local communities should be spent on prevention, education,
and treatment. Police have echoed the public's support for treatment.
In a 1996 survey, police chiefs from around the country ranked drug
abuse as the most serious problem in their communities and identified
the shortage of treatment programs as the most serious limitation in
their ability to address drug problems successfully.
CLOSING THE TREATMENT GAP IN OUR COMMUNITIES
Access to alcohol and drug treatment does not meet the current need
for services. While between 13 million and 16 million people need
treatment for alcohol and drug problems in any given year, only 3
million, or 20 percent receive treatment.
The need for treatment will only become greater in the future. A
1999 analysis of data from the National Household Survey on Drug Abuse
(NHSDA) projected that the need for future treatment is expected to
increase 57 percent because of increased marijuana first use and
problems among the aging cohort of drug abusers who first started using
illicit drugs during the 1970s.
INCREASED INVESTMENT IN PREVENTION PROGRAMS REQUIRED
To reduce the trend of increased alcohol and drug use by youth,
especially middle-school aged youth, Congress must increase its
investment in community-based prevention programs. A 1998 study found
that drug use jumps 300 percent in the first year after elementary
school. Furthermore, according to data from the Monitoring the Future
Study, ecstasy use has significantly increased in 2000 among all
students, with a 45 percent increase in use among 8th graders.
To effectively address this important problem, every adolescent
should have access to alcohol and drug prevention services, but this is
not the case nationwide. Providing universal access to effective
community and school-based prevention services requires increased
funding.
DRUG AND ALCOHOL TREATMENT, PREVENTION, AND RESEARCH FUNDING MUST BE
EXPANDED
Substance Abuse Prevention and Treatment Block Grant--SAMHSA/CSAT
The majority of SAMHSA's funding for drug and alcohol treatment and
prevention is sent directly to states through the Substance Abuse Block
Grant. The Block Grant is the primary source of federal funding for
alcohol and drug treatment and prevention services, accounting for over
40 percent of public funding for these services nationwide.
To help meet the pressing need for treatment and prevention
services, we urge Congress to fund the Block Grant at $2.0 billion for
an overall increase of $335 million of fiscal year 2002 funding.
SAMHSA/CSAT & CSAP--Balancing the Knowledge Development Application
Program with the Need to Target Services to Underserved
Populations and Emerging Drug Epidemics
Funding at the Centers for Substance Abuse Treatment and Prevention
should be directed toward two major activities: services capacity
expansion for populations at high risk or which have increased need for
treatment and prevention services and Knowledge Development and
Application (KDA). Targeting service funding allows CSAT and CSAP to
meet the evolving needs of communities by providing targeted, gap
filling services and infrastructure tailored to address specific and
emerging drug epidemics and/or underserved populations (e.g.,
methamphetamine, heroin, designer drugs, adolescents, specific racial
and ethnic groups, exoffenders, homeless persons, and women on
welfare.)
Investment in the application of research findings is also a key
Federal responsibility, and CSAT and CSAP, as the lead Federal agencies
in treatment and prevention, are singularly equipped to translate
research findings into best practices for treatment and prevention
programs.
For fiscal year 2002 we urge Congress to appropriate $350 million
each for CSAT and CSAP, a $94 million increase for CSAT and a $175
million increase for CSAP.
Safe and Drug Free Schools and Communities Act--Department of Education
Research has demonstrated that school-based prevention programs
that focus on personal and refusal skills development can significantly
reduce alcohol and drug use. The Safe and Drug Free Schools program
also provides critical intervention services by supporting student
assistance programs that refer students who are beginning to use
alcohol and drugs to appropriate services. These early intervention
programs, which have no other source of federal funding, are critical
to reaching youth at high risk early.
For fiscal year 2002 we urge Congress to appropriate $694 million
for the Safe and Drug Free Schools and Communities Act program, a $50
million increase over fiscal year 2001, with the entire increase be
directed into the States Grants program which supports local community
prevention programs.
We also ask that Congress keep the funding for the Safe and Drug
Free Schools and Communities Act program separate from the 21st Century
Program. The combination of these two programs would dilute funding
directed toward drug and alcohol prevention efforts.
Basic Research--NIH/NIAAA & NIDA
Research into the causes, costs, and ``cures'' of alcoholism and
drug dependence is an important component of our field's continuum.
This past year NIDA and NIAAA have been making great strides in
research relative to alcohol and drug dependence. These breakthroughs
have demonstrated that alcoholism and drug dependence research hones
our knowledge about addiction and improves our ability to treat and
prevent it.
To expand our knowledge of addiction and how best to treat and
prevent it, we urge Congress to appropriate $341 million for NIAAA, a
$79 million increase, and $991 million for NIDA, a $211 million
increase.
CONCLUSION
Alcoholism and drug dependence continue to be among our Nation's
most serious and costly public health problems. The programs I have
discussed this afternoon are the first line of defense to protect our
children from developing drug and alcohol problems, as well as the
funding source of last resort to treat Americans who have already
developed these problems. As a society, we must strengthen these
programs. Thank you.
______
Prepared Statement of the Lovelace Respiratory Research Institute
(LRRI)
It is proposed that the Department of Health and Human Services
(DHHS) through its constituent agencies, support the renovation of the
LRRI clinical facilities and purchase of necessary equipment to support
LRRI maintain its high research and clinical standards, better provide
appropriate data security.
LRRI has committed to a building campaign using $10 million in
private funds to improve its laboratory facilities and equipment.
LRRI's clinical study facility is in need of renovation to better
accommodate the thousands of outpatients recruited for these studies
and to better maintain security of their patient information. LRRI
requests $2 million to help renovate this facility.
PROJECT IMPACT
LRRI, as a private non-profit research institute, places top
priority on its ability to translate its basic science findings from
animal models, into protocols designed to evaluate new approaches for
treating respiratory disease. These protocols lead to new innovative
techniques and approaches to health care.
LRRI conducts clinical studies requiring the recruitment of
thousands of patients that provide the basis for making the link
between genetic and cellular defects and clinical disease presentation
and demographic characteristics. Currently, LRRI is conducting
population-based genetic studies in:
--Chronic obstructive pulmonary diseases (COPD),
--Early detectors for lung cancer,
--Pulmonary fibrosis, and
--Mechanisms of asthma and other lung diseases in Hispanic and Native
American children
Two events have greatly enhanced the ability to better understand
the mechanisms of human disease in communities. One is the dramatic
advance in molecular and cellular biology over the last 10 years,
especially in human genetics. The other is the ability to collect and
process data using advance computer systems and statistical techniques.
This process called ``molecular epidemiology'' makes the link between
genetic and cellular defects and clinical disease. LRRI has formed
collaborations with national and local a private health providers to
collect and manage patient data to carry out their ``molecular
epidemiological'' studies. These partners include, the:
--Lovelace Health Systems (LHS),
--Albuquerque Veterans Administration Medical Center (VA),
--University of New Mexico School of Medicine (UNM), and the
--University of Miami School of Medicine (UMSM).
Given the nature of the clinical studies performed, LRRI's facility
requires security mechanisms well beyond those of ordinary medical
clinics. As one can well imagine, this facility is the repository of
very sensitive personal data, including that linked to an individual's
DNA. To carry out this responsibility for privacy and confidentiality,
there is a need to renovate the facilities and equipment necessary to
be physically and electronically impenetrable to all but those who have
specific and authorized access.
The existing 8,000 sq. ft. facility was constructed in the 1950's
and requires renovation and upgrades to provide a suitable, efficient,
functional and secure facility. The proposed project would require
reconfigured space, upgrades to meet current fire and safety codes, new
interior finishes, new plumbing, upgraded electrical and a new heating,
ventilation and air conditioning system.
The current clinical trials facility is occupied in part by other
LRRI functions. Some of these functions will need to be relocated to
provide the required additional space for the clinical studies.
Unfinished space is being made available in the new research facility
included as part of the $10 million LRRI campaign. The proposed project
will include the completion of 8,000 square feet of the unfinished
space for this purpose.
Accordingly, to meet this responsibility and to improve LRRI's
ability to conduct its clinical studies, we respectfully request $2
million. The responsible Federal agency is the Health Resources and
Services Administration (HRSA).
______
Prepared Statement of the Lymphoma Research Foundation of America, Inc.
Chairman Specter, Ranking Member Harkin and esteemed members of the
Subcommittee, thank you for this opportunity to present written
testimony before you on behalf of the over 600,000 Americans living
with lymphoma and on behalf of the Lymphoma Research Foundation of
America (LRFA). LRFA is the foremost national nonprofit organization
dedicated to funding lymphoma research and providing information,
education and support to lymphoma patients and their loved ones.
The organization was founded in 1991 by Ellen Glesby Cohen, whose
own experience battling non-Hodgkin's lymphoma led her to fully
appreciate the pressing need for better, safer cancer treatments. To
date, LRFA has awarded $3 million in support of 93 lymphoma research
projects. Tragically, Ms. Cohen's battle with lymphoma ended in August
of last year.
Lymphoma is a cancer that originates in and affects the body's
immune system. Lymphoma occurs when cells that normally fight infection
abnormally multiply and form tumors. Lymphoma strikes men, women and
children of all ages, races and socio-economic backgrounds.
Three years ago, after a routine physical, my doctor told me that
he was concerned about my white blood cell count. It had been high for
a while, and he feared that I might have a form of cancer called
Chronic Lymphocytic Leukemia (CLL). He calmed me by saying that people
sometimes lived up to ten years with CLL without treatment, and
referred me to an oncologist at Mayo Clinic for further evaluation.
After several days of testing at Mayo, the oncologist told me that
I had a disease called Mantle Cell Lymphoma not CLL. I remember vividly
that he could not look me in the eye when he told me there were no
known effective treatments for it. I asked him how long I had to live.
He said that I was in the last stage of the disease, that lymphoma was
in every organ of my body, and I could have as little as six to 18
months to live.
Stunned, my wife and I felt lost. We knew nothing about lymphoma.
That evening we walked to a bookstore and started to read. We learned
that lymphoma is a cancer of the lymphatic system, a part of our immune
system, and that there are two main types of lymphoma, Hodgkin's
lymphoma, also known as Hodgkin's Disease, and non-Hodgkin's lymphoma
(NHL). We learned that about 80 percent of people diagnosed with
Hodgkin's disease, with treatment, survive for at least five years.
The prognosis is quite varied for non-Hodgkin's lymphomas, the
category I am in, for NHL is a more complex group of cancers. There are
more than 30 subtypes of non-Hodgkin's lymphoma that range from slow
growing, or indolent, to highly aggressive. Some non-Hodgkin's
lymphomas are considered curable. The majority are not curable, but are
treatable. With mine, we discovered that statistically, whether you
treat it or not, you live the same amount of time. In the complexity
that I have described lays our challenge. No one knows what causes
lymphoma.
According to ``Cancer Facts & Figures'' published by the American
Cancer Society (ACS), the number of newly diagnosed cases of lymphoid
malignancies in 2001 is estimated to be 89,600 with a 50 percent
average mortality rate for all lymphomas. The ACS also reports that the
diagnostic incidence of non-Hodgkin's lymphoma has risen a dramatic 80
percent over the last 20 years, making it the second most rapidly
rising cancer by rate of incidence in the United States. Furthermore,
lymphoma is the second leading cause of cancer-related deaths. An
astonishing 60 percent of all childhood malignancies are lymphomas, or
their cousin, leukemia. According to the National Cancer Institute
(NCI), lymphoma represents the third most frequent type of cancer in
the under 20-age group. Within these statistics, Mr. Chairman, is an
urgent human cry for leadership and focus.
Since receiving my diagnosis three years ago, I have been struck by
the almost academic pace of lymphoma research. The scientists and
researchers involved in developing diagnostic and treatment approaches
have excellent skills. The federal budget for cancer research has been
increasing, but progress has been too slow, and there is a notable lack
of urgency. To address this situation, Mr. Chairman, the Lymphoma
Research Foundation of America supports the campaign of doubling the
budget of the National Institutes of Health (NIH) by the year 2003.
The National Cancer Institute (NCI) is in the process of completing
a Progress Review Group, or PRG, on lymphoma, leukemia, and myeloma.
One purpose of the PRG is to identify the overlaps in research and
where gaps exist. As a participant in the PRG Roundtable meeting
consisting of scientists, clinicians, industry, patient advocates and
federal agencies, it was obvious that cross-disciplinary and multi-
institutional research collaboration is needed. This would enable
researchers to better communicate research results and to share
resources, reagents, and patients. Ultimately, it would result in
quickening the pace of the research itself. The PRG report produced by
this process is designed to create a national prioritized research
agenda for lymphoma and other hematological cancers. But we believe
that the recommendations alone will not bring about needed change
rapidly enough. Therefore, we request that a budget plan accompany the
report.
In addition, because of the link between lymphoma and
environmental, bacterial, and viral factors, we request the National
Institute on Environmental Health Sciences (NIEHS) to report to
Congress on the current state of its research portfolio on lymphoma and
hematological cancers. For fiscal year 2002, we request the Centers for
Disease Control and Prevention (CDC) to expand its support in
investigating the possible environmental causes of lymphoma and
increase its data collection on lymphoma to provide accurate statistics
on the disease. Both NIEHS and CDC must also be encouraged to
collaborate with NCI and the NIH to avoid overlap in their research.
Lymphoma is one of the most difficult cancers to diagnose. Indeed,
too many people are already in advanced stages of the disease when they
receive a diagnosis. Many people are also misdiagnosed, like I was, as
to the type of lymphoma they have. As a result of the highly complex
nature of the disease and the many different types of lymphoma, we
request an outreach campaign by the CDC to educate clinicians and the
general public on the symptoms associated with lymphoma and methods to
better diagnose this complicated cancer. As you are well aware, early
detection and early treatment of cancer increase one's chance of
survival.
I do not believe that the situation for those of us living with
lymphoma has to be bleak. As evidenced by exciting discoveries
resulting from the human genome project, advances in science and
technology have brought us to the brink of an explosion in our
understanding of the basic science of human malignancies. We have also
entered into one of the most exciting periods in lymphoma research as
more targeted, nontoxic therapies that attempt to modify the
immunologic and genetic abnormalities of lymphomas are developed, such
as vaccines, antisense compounds and gene therapy. Newer technologies
will eventually allow physicians to predict more reliably a patient's
response to treatment and to customize treatment strategies.
I am a beneficiary of this progress. I am currently participating
in a clinical trial at the NCI that involves treatment with a vaccine
made from my own cancer cells. But I am one of only 20 participants,
and even if successful, this treatment will take many, many years to
reach the thousands who need it.
Many scientists believe that lymphoma, because of its cellular
biology and metastatic presentation, is the perfect malignancy in which
to explore new avenues of treatment. Exciting discoveries resulting
from lymphoma research, such as monoclonal antibodies, have the
potential to benefit many other cancers, including those of the breast,
prostate, colon and lung. But the technologies and novel therapies I
described above are still early in their development and have to
surmount considerable obstacles before they become available to treat
patients. There is still a critical need for more innovative research
and collaborative efforts before our goal of more effective, safer
treatments, and ultimately, cures for lymphoma and other cancers can be
achieved. And that is why I am asking you today to continue to increase
your support of lymphoma research and to further the extraordinary
research opportunities and momentum created by this moment.
Lymphoma is the only cancer with an increasing mortality rate, in
contrast to the decreasing mortality rates of many other cancers. I do
not believe that we should consider this statistic as something beyond
our control, and therefore, tragic but acceptable. In 1998, LRFA
founder, Ellen Glesby Cohen, testified before this subcommittee. At
that time, approximately 800 people per week died of lymphoma. This
year, about 1,000 people per week will die. It is my hope that this
subcommittee will provide the leadership and means to reverse these
trends.
Thank you for the opportunity to present written testimony and
share my story with you.
______
Prepared Statement of the Medicare Payment Advisory Commission
The Medicare Payment Advisory Commission (MedPAC) requests a budget
appropriation of $8,250,000 for fiscal year 2002: the same amount as
fiscal year 2001, plus $250,000 to cover the costs of an anticipated
mandatory office relocation. This level of funding will enable the
Commission to complete the range of reports assigned to it by the
Congress under recent legislation, as well as to provide technical
support on Medicare policies to congressional committees and staff.
This testimony will discuss MedPAC's statutory mandate, our work in
fulfillment of that mandate during fiscal years 2000 and 2001, the work
we have planned in fiscal year 2002, and the resources we will need to
pursue that work.
LEGISLATIVE MANDATE
The Congress established MedPAC in the Balance Budget Act of 1997
(BBA) as an independent legislative agency to provide analysis of and
recommendations on policies affecting the Medicare program. The
Commission consists of 17 Commissioners appointed to three-year terms
by the Comptroller General. By law, Commissioners are appointed to
represent diverse points of view, including those of health care
providers, payers, consumers, and employers, and to bring expertise in
health economics and biomedical and health services research. (See
Table 1 for a listing of the Commission's members and their
affiliations).
The Commission is assisted in its work by an executive director and
professional research and administrative staff. Our professional staff
have expertise in health economics, statistics, public policy, public
health, hospital administration, medicine, and law. When specialized
data or expertise are needed, the Commission also contracts with
government agencies, trade associations, and private research firms.
Within its broad mandate, MedPAC is directed by law to consider
specific issues relating to the Medicare program. We are charged with
considering:
--Medicare payment, risk adjustment, risk selection, quality of care,
access to care, and other major issues relating to the
implementation and development of the Medicare+Choice program;
--methods to determine and update payments for different types of
health services under the traditional fee-for-service Medicare
program;
--the impact of payment policies on access to and quality of care for
beneficiaries in the traditional program;
--the effect of Medicare payment policies on the broader health care
system; and
--the effect of developments outside the program on Medicare.
The law directs the Commission to make recommendations to the
Congress on Medicare's payment policies by March 1 of each year. MedPAC
also must submit a report to the Congress addressing other issues
relating to the Medicare program by June 15 of each year. In addition,
the Commission is required to comment on reports submitted by the
Secretary of Health and Human Services to the Congress. Finally, MedPAC
must submit additional reports on specific topics of interest at the
direction of the Congress. Eighteen reports were assigned to the
Commission under the Balanced Budget Refinement Act of 1999 (BBRA), and
an additional 11 under the Medicare, Medicaid, and the SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA).
The Commission meets about eight times a year to review analyses
presented by staff and to develop and discuss its recommendations.
These meetings are open to the public, with time routinely provided for
public comment.
ACCOMPLISHMENTS DURING FISCAL YEARS 2000 AND 2001
MedPAC fulfills its mandate to assist the Congress in improving
Medicare policy in a number of ways:
--reports to the Congress required by our authorizing legislation or
by other laws,
--formal testimony before the authorizing Committees of the House and
the Senate,
--formal comments to the Secretary of Health and Human Services on
proposed regulations, and
--technical analyses and briefings by Commission staff for
congressional staff.
Statutorily required reports
The Commission submitted its March 2001 report to the Congress on
time. This report contained the Commission's recommendations concerning
Medicare payment policy issues and presented supporting analyses and
reasoning behind the Commission's views. The report addressed the
following areas:
--evaluating Medicare's payment policies,
--updating payments for physician services and for care provided in
hospital outpatient departments,
--accounting for new technology in hospital prospective payment
systems (PPS),
--developing input-price indexes for all health care settings,
--financial performance and inpatient payment issues for PPS
hospitals,
--prospective payment for post-acute care,
--reconciling Medicare+Choice payments and fee-for-service spending,
--end-stage renal disease payment policies in traditional Medicare,
--reducing beneficiary coinsurance under the hospital outpatient
prospective payment system, and
--treatment of the initial residency period in Medicare's direct
graduate medical education payments.
The Commission will submit its second mandated report for the year
on June 15, 2001. This report focuses on the Commission's examination
of issues affecting the Medicare program in rural areas. The June
report will include the following topics:
--overview of rural markets and Medicare,
--rural beneficiaries' access to care,
--prospective payment for hospitals in rural areas,
--home health payment issues,
--prospective payment systems for outpatient hospital services,
--Medicare+Choice in rural areas, and
--quality of care issues for rural beneficiaries.
This report will address several issues MedPAC was directed to
study under the BBRA, including:
--the appropriateness of prospective payment for home health agencies
in rural areas,
--the adequacy of Medicare's payment provisions for rural providers,
--the appropriateness of prospective payment for rural psychiatric
hospitals, and
--the appropriateness of applying the prospective payment system for
hospital outpatient departments to certain rural hospitals.
The June report will also include MedPAC's review of the
sustainable growth rate and conversion factor for physician services,
as required by the Congress.
The BBRA required that MedPAC review several policies in
Medicare+Choice and on Medicare payment for post-surgical recovery care
centers. In November 2000, MedPAC fulfilled these requirements by
submitting three reports to the Congress: ``Medical Savings Accounts
and the Medicare Program, Improving Risk-adjustment in Medicare, and
Medicare Payment for Post-surgical Recovery Care Centers.'' In May
2001, the Commission will submit reports as required under the BBRA on
Medicare payment for clinical training of non-physician health
professionals in hospitals and on payment for skilled nursing
facilities in Alaska and Hawaii.
During the next fiscal year, Commission staff will continue to
prepare and distribute other reports containing information from its
analyses and research requested by the Congress or initiated on its
own. Some of these reports will result from analyses undertaken by the
Commission staff; others will contain findings from research and
analyses conducted under external research contracts.
Testimony
During fiscal years 2000 and 2001, the chair of the Commission
testified before the House Committee on Ways and Means, Subcommittee on
Health and the House Committee on Commerce. Her testimony before the
Ways and Means Subcommittee focused on the impact of the BBA on
patients, providers and Medicare+Choice plans and her testimony before
the Commerce Committee addressed the impact of the BBA on patients and
providers. During this period, the executive director testified before
the House Committee on Commerce and the Senate Committee on Finance.
The executive director's testimony before the Commerce Committee
addressed accounting for new technology in the hospital prospective
payment system. Before the Finance Committee he addressed issues
surrounding the Medicare+Choice program.
In addition, the Commission expects to provide further testimony on
subjects related to its expertise during fiscal year 2002. Members of
the Commission and staff will continue to provide briefings, technical
advice, and other support to members of the Congress and their staff.
The Commission also works with the Health Care Financing Administration
(HCFA) and a number of private sector groups concerning Medicare
payment for facility and physician's services and Medicare+Choice, as
well as broader changes in health care financing and delivery.
Comments on proposed regulations
Since enactment of the BBA, the Commission has closely monitored
implementation of the law by the Secretary and has commented on
proposed rules and interim final regulations. Although MedPAC is not
required by law to comment on proposed regulations, we do so in cases
where we feel that the Congress benefits from having an independent
assessment. Further, making comments as the regulations are developed
provides the Congress (and the Secretary) with more timely advice than
we can provide in our March or June reports. In fiscal year 2000,
MedPAC submitted formal comments on the Secretary's proposal for the
prospective payment system for home health services.
FUTURE WORK
Our priorities for the upcoming fiscal year include working on our
two mandated reports, focusing on access and quality of care,
continuing our work on Medicare in rural areas, and examining the
regulatory complexity of the Medicare program. We also will continue to
monitor the impact of changes in payment for ambulatory care services
including hospital outpatient department and physicians, evaluate
payment policies for post-acute care, and examine issues in
Medicare+Choice.
Other topics the Commission will pursue were defined by the
Congress under the BBRA and the BIPA. These include payments to
Medicare+Choice plans, appropriate quality standards, skilled nursing
facility payment, use of and payment for physician services, examining
the use of consumer coalitions in marketing of Medicare+Choice plans,
access to and use of the hospice benefit, Medicare coverage of services
provided by certain allied health providers, the shortage of
geriatricians, and the implications of the hospital-specific cap on
residents in Medicare's graduate medical education payments. The
Commission further anticipates that the Congress will continue to seek
its advice and analytic help in monitoring implementation of the
Medicare provisions of the BBA, the BBRA, and the BIPA, and the
Congress continues work on legislation affecting the Medicare program.
MedPAC's staff is beginning to develop research projects on these
and other topics. Commissioners will meet in July to discuss which
projects should be given emphasis and we will discuss our analytic
agenda at our public meetings.
APPROPRIATIONS REQUEST
As noted above, MedPAC is requesting $8,250,000 for fiscal year
2002, the same amount as fiscal year 2001, plus $250,000 to cover the
costs of an anticipated mandatory office relocation. We propose to
allocate a large portion of the requested funds to external research
contracts to support the numerous reports request by the Congress (see
Table 2).
We also plan to target funding towards salaries and benefits in an
effort to achieve the staff size needed to fulfill our responsibilities
and to provide the maximum support to Congress. Although, the
Commission continued to experience staff turnover during fiscal year
2001 through aggressive recruiting we have attracted several highly
qualified individuals. Despite a tight labor market for health policy
analysts--particularly senior people with extensive knowledge of the
Medicare program--we hope to be fully staffed at the beginning of
fiscal 2002 to allow us to fully respond to the many responsibilities
given to us by the Congress.
TABLE 1.--MEMBERS OF THE MEDICARE PAYMENT ADVISORY COMMISSION AND THEIR
AFFILIATIONS
------------------------------------------------------------------------
Member Affiliation
------------------------------------------------------------------------
Gail R. Wilensky, Ph.D., Chair, Bethesda, Project HOPE, Center for
MD. Health Affairs
Joseph P. Newhouse, Ph.D., Vice Chair, Harvard University
Boston, MA.
Beatrice Braun, M.D., Spring Hill, FL..... American Association of
Retired Persons
Autry O.V. ``Pete'' DeBusk, Powell, TN.... DeRoyal
Glenn M. Hackbarth, J.D., Bend, OR........ Independent consultant
Spencer Johnson, Lansing, MI.............. Michigan Health and Hospital
Association
Floyd D. Loop, M.D., Cleveland, OH........ The Cleveland Clinic
Foundation
Alan R. Nelson, M.D., Washington, DC...... American College of
Physicians--American
Society of Internal
Medicine
Janet G. Newport, Santa Ana, CA........... PacifiCare Health Systems
Carol Raphael, New York, NY............... Visiting Nurse Service of
New York
Robert D. Reischauer, Ph.D., Washington, The Urban Institute
DC.
Alice Rosenblatt, F.S.A., M.A.A.A., Wellpoint Health Networks
Thousand Oaks, CA.
John W. Rowe, M.D., Hartford, CT.......... Aetna US Healthcare
David A. Smith, Washington, DC............ AFL-CIO
Ray E. Stowers, D.O., Tulsa, OK........... Oklahoma State University--
College of Osteopathic
Medicine
Mary K. Wakefield, Ph.D., Fairfax, VA..... George Mason University
------------------------------------------------------------------------
TABLE 2.--BUDGET AUTHORITY, MEDICARE PAYMENT ADVISORY COMMISSION
[In thousands of dollars]
------------------------------------------------------------------------
Fiscal year
---------------------- Fiscal
Object classification 2002 Change year 2002
actual 2001 plan request
------------------------------------------------------------------------
Salaries:...................
Full-time staff......... $2,439 $2,911 ......... $2,911
Commissioners........... 152 182 ......... 182
-------------------------------------------
Subtotal.............. 2,591 3,093 ......... 3,093
===========================================
Benefits.................... 631 760 ......... 760
===========================================
Travel:.....................
Staff................... 37 31 ......... 31
Commissioners........... 77 100 ......... 100
-------------------------------------------
Subtotal.............. 109 131 ......... 131
===========================================
Standard level user charges. 349 355 ......... 355
Mainframe computer.......... 941 755 ......... 755
Telephone................... 56 50 ......... 50
Postage..................... 53 90 ......... 90
-------------------------------------------
Subtotal.............. 1,050 895 ......... 895
===========================================
Printing and reproduction... 160 250 -$32 218
Computer programming........ 870 900 ......... 900
Research contracts.......... 590 1,230 -30 1,200
Commercial contracts........ 222 230 +250 480
Government contracts........ 1 1 0 1
GSA support................. 60 66 +2 68
-------------------------------------------
Subtotal.............. 1,743 2,427 +222 2,649
===========================================
Supplies.................... 38 38 ......... 38
Publications................ 34 33 ......... 33
-------------------------------------------
Subtotal.............. 72 71 ......... 71
===========================================
Equipment and furnishings... 23 18 +60 78
===========================================
Lapsing..................... 230 ......... ......... .........
===========================================
Total................. 7,015 8,000 +250 8,250
------------------------------------------------------------------------
Note.--Numbers may not add to totals because of rounding.
______
Prepared Statement of the Medical Library Association and the
Association of Academic Health Sciences Libraries
INTRODUCTION
Mr. Chairman, thank you for the opportunity to submit testimony on
behalf of the Medical Library Association (MLA) and the Association of
Academic Health Sciences Libraries (AAHSL) regarding the fiscal year
2002 budget for the National Library of Medicine (NLM). I am Marianne
Comegys, associate professor of medical library science at the
Louisiana State University Health Sciences Library in Shreveport, La.
MLA is a professional organization, headquartered in Chicago,
representing over 4,000 individuals and 1,200 institutions involved in
the management and dissemination of biomedical information to support
patient care, education and research. In 1998, the organization
celebrated its 100th anniversary.
AAHSL, is comprised of the directors of libraries of 142 accredited
United States and Canadian medical schools belonging to the Association
of American Medical Colleges. Together, MLA and AAHSL address health
information issues and legislative matters of importance to the medical
library community through a joint legislative task force.
Mr. Chairman, the National Library of Medicine, on the campus of
the National Institutes of Health in Bethesda, Maryland, is the world's
largest medical library. The Library collects materials in all areas of
biomedicine and health care, as well as works on biomedical aspects of
technology, the humanities, and the physical, life, and social
sciences. The collections stand at 5.8 million items--books, journals,
technical reports, manuscripts, microfilms, photographs and images.
Housed within the Library is one of the world's finest medical history
collections of old and rare medical works. The Library's collection may
be accessed in the reading room or requested on interlibrary loan. NLM
is a national resource for all U.S. health science libraries through a
National Network of Libraries of Medicine.
On behalf of the medical library community, I would like to thank
the subcommittee for its leadership in securing a 15 percent increase
for NLM in fiscal year 2001. With respect to the Library's budget for
the coming fiscal year, I would like to touch briefly on four issues;
(1) NLM's basic services, (2) NLM's outreach and telemedicine
activities, (3) NLM's PubMed Central and clinical trials databases, (4)
and NLM's facilities needs.
THE GROWING DEMAND FOR NLM SERVICES
Mr. Chairman, it is a tribute to NLM that the demand for its
services continues to steadily increase each year. An average of 250
million Internet searches (30 percent from the general public) are
performed annually on NLM's MEDLINE database, which provides access to
the world's most up to date health care information. Moreover; medical
libraries, academic health centers, hospitals, community health
centers, veterans health care facilities, and private physicians rely
heavily on NLM and its National Network of Libraries of Medicine to
deliver quality health care everyday.
NLM also plays a critical role in maintaining the integrity of the
world's largest collection of medical books and journals. Increasingly,
this information is in digital form, and 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 highest priority of the Library.
Mr. Chairman, simply stated, NLM is a national treasure. I can tell
you that without NLM our nation's medical libraries would be unable to
provide the type of information services that our nation's health care
providers, educators, researchers and patients have come to expect.
Recognizing the invaluable role that NLM plays in our health care
delivery system, the Medical Library Association and the Association of
Academic Health Sciences Libraries join with the Ad Hoc Group for
Medical Research Funding in recommending a 16.5 percent increase for
NLM and NIH overall in fiscal year 2002.
NLM'S OUTREACH AND TELEMEDICINE ACTIVITIES
Outreach and Education
NLM's outreach programs are of particular interest to both MLA and
AAHSL. These activities, designed to educate medical librarians, health
care professionals and the general public about NLM's services, are an
essential part of the Library's mission.
The need for enhanced outreach activities has grown significantly
in recent years following NLM's decision to make its MEDLINE database
available for free over the World Wide Web. The Library has taken a
leadership role in promoting educational outreach aimed at public
libraries, secondary schools, senior centers and other consumer-based
settings. We were pleased that the Committee again last year recognized
the need for NLM to coordinate its outreach activities with the medical
library community.
Mr. Chairman, we applaud the success of NLM's outreach initiatives
and look forward to continuing our work with the Library again in
fiscal year 2002 on these important programs.
Telemedicine
Mr. Chairman, telemedicine continues to hold great promise for
dramatically increasing the delivery of health care to underserved
communities across the country and throughout the world. NLM has
sponsored over 50 telemedicine related projects in recent years,
including 21 multi-year projects located in various rural and urban
medically underserved communities. These sites serve as models for:
--Evaluating the impact of telemedicine on cost, quality, and access
to health care;
--Assessing various approaches to ensuring the confidentiality of
health data transmitted via electronic networks;
--Testing emerging health data standards.
Mr. Chairman, it is clear that telemedicine will play a major role
in the delivery of health care in the 21st Century. Medical librarians
and health information specialists have an important role to play in
supporting this revolutionary approach to health care and we encourage
Congress and NLM to continue their strong support of telemedicine in
our nation's medically underserved areas.
PUBMED CENTRAL /CLINICAL TRIALS DATABASE
The medical library community applauds NLM for its leadership in
establishing PubMed Central, an online repository for life science
articles introduced in early 2000. PubMed Central evolved from an
electronic publishing concept proposed by former NIH Director Dr.
Harold Varmus. The site houses articles from the Proceedings of the
National Academy of Sciences, the American Society for Cell Biology's
journal Molecular Biology of the Cell, and other publications.
This new online resource will significantly increase access to
biomedical information by health care professionals, students,
researchers and the general public. The medical library community
believes that health sciences librarians have a key role to play in the
further development of PubMed Central. Because of the high level of
expertise health information specialists have in the organization,
collection, and dissemination of medical literature, we believe our
community can assist NLM in issues related to copyright, fair use, and
information classification on the PubMed Central site. We look forward
to collaborating with the Library as this exciting new project
continues to unfold this year.
Mr. Chairman, I also want to comment on another relatively new
service offered by NLM--its clinical trails database
(Clinicaltrials.gov). This listing of some 5,200 federal and privately
funded trials for serious or life-threatening diseases was launched in
February of 2000. This free service is currently logging more than 2
million page hits a month and is an invaluable resource to patients and
families interested in participating in cutting edge treatments for
serious illnesses. The medical library community congratulates NLM for
its leadership in creating
ClinicalTrials.gov and looks forward to assisting the Library in
anyway possible to advance this important initiative. This database is
a nice compliment to NLM's extremely successful consumer web-site
MEDLINEplus, which now covers over 450 health topics.
NLM'S FACILITIES NEEDS
Mr. Chairman, over the past two decades NLM has assumed several
major new responsibilities particularly in the areas of biotechnology,
health services research, high performance computing, and consumer
health. As a result, the Library has had tremendous growth in its basic
functions related to the acquisition, organization, and preservation of
an ever-expanding body of biomedical literature.
This increase in the volume of biomedical information as well as
Library personnel (NLM currently houses over 1,100 people in building
built to accommodate 650) has resulted in a serious shortage of space
at the Library. In addition, the National Center for Biotechnology
Information at NLM builds sophisticated data management tools for
processing and analyzing enormous amounts of genetic information
critical to advancing the Human Genome Project.
In order for NLM to continue its mission as the world's premier
biomedical library, a new facility is urgently needed. The NLM Board of
Regents has assigned the highest priority to supporting the acquisition
of a new facility. The medical library community is pleased that
Congress last year appropriated the necessary architectural and
engineering funds for facility expansion at NLM. We encourage the
subcommittee to continue to provide the resources necessary to acquire
a new facility and to support the Library's health information
programs.
Mr. Chairman, thank you once again for the opportunity to present
the views of the medical library community.
______
Prepared Statement of The Mended Hearts, Inc.
I am Robert H. Gelenter, the legal representative for the Mended
Hearts Inc, a national heart disease patient support group of 25,000
members across the country. We visit patients in about 450 hospitals
throughout the United States. I have been appointed by the group to
assist in this lobbying effort--a volunteer position.
More than 25 years ago, I was diagnosed with a rare heart disease.
After having severe chest pains and trouble breathing for more than two
years, I was diagnosed with hypertrophic cardiomyopathy, a disease in
which the heart enlarges. The heart muscle eventually thickens so much
that it can't pump blood effectively and does not grow in the normal
parallel patterns. More than 35 percent of young athletes who die
suddenly die from this disease. But, it affects men and women of all
ages. It is sudden and one of the things known about this disease is
sudden cardiac death. There is no cure for this disease. Medication may
work and there is surgery that may or may not alleviate the pain. If
that doesn't work a patient may need a heart transplant, yet spare
organs are scarce. The doctor who made my diagnosis was trained at the
National Heart, Lung, and Blood Institute of the National Institutes of
Health.
Initially, I received several medications which allowed me to
engage in most activities. But, some activities, such as walking up
hills, gave me problems like shortness of breath and severe chest
pains. But, generally I could function normally. However, after about
10 years, the discomfort was increasing, and it became apparent that I
was in serious trouble. I could not walk sixty feet without having to
stop to catch my breath. Sometimes the pain was so great that I would
almost double over in the middle of the street. My wife told me that my
face would become gray. The perspiration would pour off by body. If I
was lucky I could find a chair to sit on. The quality of my life had
deteriorated so drastically that I knew I needed some treatment.
Finally in 1988, I went to Georgetown University Medical Center for
an angiogram--the gold standard for diagnosing heart problems. The
cardiologist who performed the angiogram told me that he had bad news
and worse news. The bad news was that I had a 95 percent blockage in my
left anterior descending heart artery--the so-called ``widow makers
spot.'' The worse news was that I had a major chance of having a major
heart attack with a less than a 5 percent chance of surviving that
heart attack because of the hypertrophic cardiomyopathy. At this point,
my wife was quietly crying and I was perspiring profusely. Since
Georgetown University Medical Center did not have the expertise to
operate on me, they called the NIH to see if they would accept me as a
patient. I was sent home pending notice from the NIH.
My parents begged me to go to New York or San Francisco for second
opinions. But, I knew that I had run out of alternatives. No matter
what the result, I needed treatment and I needed it immediately.
I was accepted by the NIH. After entering the National Heart, Lung,
and Blood Institute on February 6th, I was operated on February 11th,
1988. No matter how trite the expression--that was the first day of the
rest of my life. The surgery, considered drastic and rare, is still
considered the gold standard throughout the world for the treatment of
hypertrophic cardiomyopathy. The Murrow Procedure, in honor of the
creator, was developed and improved at the NIH.
Although this surgery is no longer performed at the National Heart,
Lung, and Blood Institute, there is another experimental ongoing
protocol in which the same effect is being attempted by using alcohol
to deaden the excessive heart tissue.
Now, I am on medication for the rest of my life. My condition is
progressive. Five years ago, I was fitted with a pacemaker to insure
that my heart beats at the correct rate. I am 100 percent dependent on
this pacemaker. Without the pacemaker, there are times when my normal
heart beat is so slow that I would die.
I am eternally grateful to the physicians funded by the National
Heart, Lung, and Blood Institute, particularly to Dr. MacIntosh and his
staff, for the gift of life. Because of this marvelous research
supported by the NHLBI, I have lived 13 years pain free. I have seen
two children graduate from college and three grandchildren born, I have
shared these years with a wonderful wife. I have been able to work at
my profession--an attorney at law.
I have had the gift of life restored to me. So to express my
gratitude for that gift, I visit patients recovering from heart
episodes at two hospitals, Washington Hospital Center and Washington
Adventist Hospital.
I ask for a doubling of the fiscal year 1998 National Heart, Lung,
and Blood Institute budget by fiscal year 2003. As the fourth increment
toward reaching that goal, I advocate a fiscal year 2002 appropriation
of $2.679 billion for the NHLBI, including $1.650 billion for its heart
disease and stroke-related budget.
My experience is the proof that the research supported by the
Institute benefits not just the patients at the NIH Clinical Center,
but throughout the United States. The benefits go worldwide as well.
Heart attack, stroke and other cardiovascular diseases remain the
No. 1 killer and major cause of disability of men and women in the
United States. Nearly 41 percent of people who die in the United States
die from cardiovascular diseases. This year, nearly 950,000 Americans
will die from cardiovascular diseases, including more than 150,000
under the age of 65.
______
Prepared Statement of Miami Children's Hospital
In recognition of the indispensable role that independent
children's hospitals, like Miami Children's Hospital, play in
children's health, I urge you to continue the commitment to the
Children's Hospital Graduate Medical Education (``GME'') program by
calling for and supporting full funding this year.
As President and Chief Executive Officer of Miami Children's
Hospital, I am very concerned about the cut in funding the
Administration is proposing for the GME program this year. The
Children's Hospital Graduate Medical Education program provides funding
to about 60 independent children's hospitals that were left out of a
GME financing system that depends on Medicare. Children's hospitals do
not qualify for Medicare GME support which leaves a gap of $285 million
annually. As you know, Congress passed legislation in 1999 to address
this inequity. The $235 million authorized last year takes a big step
in the right direction to reaching the $285 million goal. Achieving an
appropriation of $285 million this fiscal year will make an essential
investment in the children's hospitals' missions as centers of
education and research, and regional centers of excellence.
Instead of moving towards that goal, the Administration has
announced that the President's budget will propose a 15 percent cut, an
equivalent of $35 million, for GME payments to children's hospitals.
Independent children's hospitals make up only one percent of all
hospitals, train thirty percent of pediatricians, fifty percent of
specialists, and a larger portion of pediatric researchers. Despite
these significant contributions, the survival of these institutions is
contingent upon reaching the $285 million goal and thus closing the
gap.
I look forward to your continued support for GME funding.
Miami Children's Hospital (MCH) hereby submits for the record,
testimony regarding the need to develop a significant Ambulatory Care
Center at Miami Children's Hospital.
Miami Children's Hospital is a private, non-profit entity that
offers a full range of services from birth to age 21 with primary care
pediatrics as the cornerstone. Also, MCH is the largest provider of
Pediatric Orthopedics in Miami Dade County. By percentage of net
revenue, Miami Children's Hospital is the largest Medicaid provider for
children in the state of Florida. The services include preventive
medicine, the only children's hospital in Florida with such a
department, and the most sophisticated medical and surgical tertiary
care.
Miami Children's Hospital is South Florida's only independent,
free-standing licensed specialty hospital exclusively for children. Our
mission to provide excellent family centered health care has helped us
pave the way to our continuing success. Some of the success along our
path include: being the only children's hospital in Florida to
successfully separate conjoined twins; it is the leading child
neurological facility in the region. Furthermore, MCH houses the only
pediatric cardiac intensive care unit in the Southeastern United
States. It is one of only 10 centers nationwide selected to participate
in the clinical trial of CardioSEAL, a revolutionary closure device to
be used in treating children with atrial septal defects. It was
successfully completed in its first clinical trial.
The Hospital is also very pleased to have been ranked first in
Florida, second in Southeast and tied 14th in the country as top
hospital by Child Magazine. This recognition highlights our dedication
to pediatric excellence and focuses on the outstanding work taking
place in South Florida. For example, MCH is the first hospital in the
state of Florida to have pediatric Extra Corporeal Membrane Oxygenation
(ECMO) available. This procedure allows children born with certain
system failures, such as renal or cardio-pulmonary, to have an
effective oxygenation of blood while recovering. In addition, Miami
Children's Hospital has been the first in the United States and in the
international arena in spearheading many procedures. For instance, it
was the first in the United States to perform a tracheal transplant. It
was first in the Southeastern United States to perform a tracheal
transplant. It was first in the Southeastern United States in
performing reconstructive surgery for brachial plexus injuries as well
as in repairing Pectus Excavatus (sunken chest). MCH also performed the
world's first extracardiac Fontan operation that did not require
cardiopulmonary bypass, i.e., the need of heart lung machine, and the
world's first endoscopic ventricular thrombectomy, i.e., removal of
cardiac clot without surgery. It also led the world's first conference
on minimally invasive surgery for congenital heart disease and hosted
the first Youth Leadership Conference on Health. MCH is also credited
with developing the first international medical teleconference in
pediatrics. It was first in the United States and the Americas to use
the Helex Septal Occluder to treat atrial septal device (ASD), a common
heart defect.
Miami Children's Hospital is dedicated to the development of
technology that will be less invasive to children. Always at the
forefront of cutting-edge technology, most recently, MCH created a
pediatric brain tumor center. The cornerstone of the new center will be
a powerful new tool for treating brain cancer: an interoperative
magnetic resonance imaging (MRI) unit that can be rolled into the
operating room to provide surgeons with real-time scans of the child's
brain. The resulting accuracy will bring new levels of confidence to
parents and doctors that all of the tumor has been removed.
The demand for pediatric care services has grown enormously,
especially in Miami Dade County, since MCH is the only hospital
exclusively for children in the region and indeed in South Florida. To
meet these growing needs, we are presently engaged in the construction
of a new Ambulatory Care Center that will serve to meet the needs of a
growing population of our patients. The three story Ambulatory Care
Building would provide patient services for the following pediatric
specialties: Orthopedics, Rheumatology, Urology, Nephrology, Urodynamic
Laboratory, Enuresis Center, Dermatology, Neurosciences, Behavioral
Health, and Pediatric Dentistry. Our goal to meet the growing demand
for children's services helped create the Miami Children's Hospital Dan
Marino Center in South Florida. An extension of MCH, it is an
integrated neuro developmental center specializing in the diagnosis and
treatment of children at risk for developmental and psychological
problems.
Even with such innovative technologies and procedures, MCH still
finds itself unable to meet the growing needs of children. Miami
Children's Hospital treats more than 185,000 children each year. The
Hospital is faced with severe waiting list challenges, for certain
services (i.e. child neurological services) the wait can be up to six
weeks or more. The Hospital has for two decades made investments
through its own services, as well as through community-based
contributions.
A major component of Miami Children's Hospital is its mission and
commitment to early intervention and preventive medicine. Miami
Children's Hospital's mission is on track to become a leading pediatric
preventive medicine institute in the United States. For example, Miami
Children's Hospital has established mobile pediatric health vans called
the ``Health-on-Wheels'' program to reach underserved and disadvantaged
areas. Since September 1995, two 40-foot, mobile Health-on-Wheels
vehicles carrying state-of-the-art medical and dental facilities, in
the hands of board-certified pediatricians, pediatric nurse
practitioners, nurse assistants and paramedics, have served over 22,000
children in Dade and Monroe counties. As of 1998, the Program has
administered 13,510 immunizations, 4,129 tuberculosis screens and 8,721
hearing and vision tests. Of the 14,000 children evaluated, 11 percent
were diagnosed with an acute medical condition.
The Hospital has a state-of-the-art critical care transport service
for patients in need of specialty care using ground ambulance,
helicopter or fixed-wing aircraft called ``LifeFlight''. The helicopter
is one-of-a-kind in that it can transport two patients, travel up to a
200 mile radius and is configured with state-of-the art medical
technology. LifeFlight is used in conjunction with other transportation
to bring patients from Florida, as well as world-wide to the Hospital.
Miami Children's Hospital has excellent clinical services, medical
research and a comprehensive teaching program for doctors, nurses and
medical specialists. The Hospital has eliminated the need to send
Florida's children elsewhere to get the medical attention they so
desperately need. Additionally, Miami Children's Hospital offers array
of services that draw children world-wide to the Hospital. Programs
that have been established at Miami Children's Hospital can be used in
other parts of the United States.
Moreover, area hospitals are sending their patients to Miami
Children's Hospital because of its focus on early intervention and
treatment, especially given their specialization in developmental
disabilities, as well as the use of the Hospital's expansive imaging
equipment. There is no need to send Florida's children elsewhere to get
the medical attention they so desperately need.
As you know, funding to improve health care services and access to
health care facilities for children has been a priority for Congress.
Therefore, we would appreciate any assistance you may be able to render
to ensure that children in need of special care receive the quality
care they deserve, by including $4 million for the Miami Children's
Hospital Ambulatory Care Center in the fiscal year 2002 Labor, Health
and Human Services, and Education Appropriations Bill.
The estimated cost of construction for the entire Ambulatory Care
Center is $13.2 million. We are requesting that approximately $4
million dollars of this cost be funded by the federal government,
possibly through the Health Resources and Services Administration's
Facilities account. The balance of the funding for the project will be
supported as follows: one-third through philanthropic contributions via
the Miami Children's Hospital Foundation and one-third through
operating money generated by the hospital.
Miami Children's Hospital wishes to express its deep appreciation
to this Committee for permitting us to submit this presentation on
Miami Children's Hospital's Ambulatory Care Center. Your positive
response for Miami Children's Hospital's request for support will have
a positive impact on the health and well-being of our children in need.
Thank you.
______
Prepared Statement of the Mississippi Department of Rehabilitation
Services
Thank you for the opportunity to present testimony for the record
on an issue vital to Americans with disabilities--the need for adequate
funding for every state's vocational rehabilitation program.
Established in 1920, the Public Vocational Rehabilitation Program
(VR) is the cornerstone of our nation's commitment to people with
disabilities toward becoming economically independent. Last year, the
vocational rehabilitation program assisted 235,000 Americans with
disabilities to go to work. The combined income of these 235,000
individuals during their first year of employment was a staggering $3.1
billion. Vocational Rehabilitation works!
However, the current federal funding formula threatens to slam shut
the door of opportunity for a vast number of these citizens. While a
mandatory cost-of-living adjustment applies to the entire program, a
different formula prescribed in the Rehabilitation Act (as amended by
the Workforce Investment Act of 1998) applies to how funds are
allocated to the states. For example, while the national program has
received annual two to three percent cost-of-living (COLA) increases
from Congress during the past eight years, many states have gotten less
than the COLA during each of those years. Specifically, in Federal
fiscal year 2000, 22 states (including Mississippi) received less than
the 1.24 percent COLA increase, and six actually received fewer dollars
during Federal fiscal year 2000 than in Federal fiscal year 1999. A
majority of states--29 in all--received less than the Federal fiscal
year 2001 COLA of 2.6 percent provided in the Congressional
appropriation. Unless the formula is fixed, more will follow.
Compounding this problem is the fiscal pressure exerted on the
vocational rehabilitation program. For example:
--The success of the Individuals with Disabilities Education Act
(IDEA) means that more young adults than ever before are
entering the vocational rehabilitation program for post-
secondary training leading to employment.
--Post-secondary tuition has skyrocketed to 200-300 percent above any
COLA increase.
--Medical costs are inflating at an alarming rate and will continue
to do so.
--The use of assistive technology (such as computerized wheelchairs)
in the rehabilitation of Americans with disabilities involves
significant expense.
--Because of Welfare-to-Work, the Ticket to Work/Workforce Incentives
Improvement Act and the Workforce Investment Act, a large pool
of previously unemployed adults is now entering the workforce.
Americans with disabilities have high expectations for the future.
They're becoming better educated and eagerly expect to work in
competitive, skilled jobs. As a nation, we have an obligation to ensure
that every citizen is able to attain the dignity that comes with
employment and self-reliance.
With the projected Consumer Price Index (CPI) for Federal fiscal
year 2002 at 3.4 percent, and without some language to hold states
harmless from the application formula, more than 20 states will fall
short of this CPI and thousands of Americans with disabilities won't
receive the services they need to go to work.
It was never the intent of Congress that any state should receive
less than a COLA increase. On behalf of Americans with disabilities, I
respectfully request that:
--the attached ``Amendment for Appropriations for Vocational
Rehabilitation'' language be adopted;
--every state receive ``hold harmless'' protection at the actual
percentage of the cost-of-living increase so that no state
loses federal dollars, as happened during fiscal year 2000;
--an additional appropriation of $19.1 million be made to the
vocational rehabilitation program to remedy the COLA problem;
and
--each state receive a 5 percent increase in new federal funds (above
the COLA) to meet the increasing demands upon its vocational
rehabilitation program.
The very future of Americans with disabilities is at stake. Thank
you for this opportunity to express my concerns and solutions.
______
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.
Most homeless people have some contact with mainstream social services
programs; indeed, a 1996 study funded by the Interagency Council on the
Homeless found that 62 percent of currently homeless people in
families, and 22 percent of those single, were receiving some type of
income-based government assistance.
Recommendation: Encourage all programs to collect information about
housing status among those the program serves.--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. State agencies administering TANF, and
recipients of substance abuse and mental health block grants should, at
a minimum, be required to monitor and report on clients' housing
status, as the success of their programs depends greatly on housing
stability.
Recommendation: Encourage TANF, Foster Care and Substance Abuse and
Mental Health block grant reporting agencies to include a description
of preventing and ending homelessness in their annual State plans.--
Many homeless people come from these systems of care. The homeless
assistance system, while it provides temporary housing services for
people while they are homeless, can not stop the flow of people
entering its doors. Rather, the mainstream programs should be aware of
the integral role they play in preventing and ending homelessness.
Recommendation: Require recipients of PATH, GBHI, and Healthcare
for the Homeless program funds to implement and participate in homeless
management information systems.--Many communities are implementing
``homeless management information systems'', and some have integrated
data collection across systems of service (i.e. shelters, criminal
justice, psychiatric facilities). Recipients of HUD targeted homeless
funds are required to collect data on homelessness in order to prevent
duplicate counting of homeless persons, and to analyze their patterns
of use of assistance. PATH, GBHI and Healthcare for the Homeless
grantees should also be collecting the data necessary to properly serve
the homeless population, and therefore more effectively expend limited
resources.
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: No tolerance for discharge into homelessness from
residentially-based programs in HHS.--No system of care should be
discharging people into homelessness. The homeless assistance system is
not large, or well-funded, enough to accommodate people being shifted
out of other systems of care, nor should it be. We need to make
mainstream systems more accountable in order to close the front door
into homelessness. Some localities--after recognizing the cost shifting
occurring between various publicly-funded institutions--have started to
implement discharge planning as requisite and/or part of performance
goals. Every locality should be required to follow suit.
OPENING THE BACK DOOR OUT OF HOMELESSNESS AND INTO 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.
Most of the chronically homeless, therefore, are already being served
by, or are eligible for, services funded by the Department of Health
and Human Services.
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.
These services are especially urgent given the Department of
Housing and Urban Development's emphasis on funding the housing, not
the services, associated with homeless assistance programs. 30 percent
of the funds in the HUD homeless programs is reserved for permanent
housing. This is a unique opportunity to build infrastructure in
communities to move the most disabled and chronically homeless people
out of homelessness. But these same housing projects need services in
order to be successful.
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. Last
year the Committee appropriated $10 million for substance abuse
treatment for homeless people. An expansion of this program would
supplement the funds committed for housing by HUD, and greatly increase
program success.
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 $172 million for Health Care for the
Homeless (through a $2 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.
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.
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.
______
Prepared Statement of the National Alliance for Eye and Vision Research
and the Foundation Fighting Blindness
The National Alliance for Eye and Vision Research (NAEVR) and the
Foundation Fighting Blindness are pleased to have the opportunity to
submit their views to the Subcommittee. NAEVR is a nonprofit advocacy
coalition of 37 eye research organizations dedicated to expanding our
national capacity to address eye and vision research opportunities. The
Foundation Fighting Blindness is a non-profit research foundation
dedicated to finding treatments and cures for retinal degenerative
diseases such as retinitis pigmentosa, macular degeneration and Usher
syndrome. These blinding eye diseases affect over 6 million Americans
of every age and ethnicity. The Foundation Fighting Blindness supports
17 interdisciplinary research centers and over 150 targeted grant
programs around the country.
We would like to begin by thanking the Subcommittee for your
continuing commitment to biomedical research supported by the National
Institutes of Health (NIH) and the National Eye Institute (NEI).
Congress has been tremendously supportive of pushing the frontiers of
medical research through 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. With this funding, NEI supported researchers have
developed several promising experimental treatments with the potential
to halt vision loss and restore sight for millions of Americans. We are
now at a turning point. Clinical trials testing a number of new
treatments are within our grasp. To advance these promising treatments
to clinical trials requires even greater financial commitment from
organizations like The Foundation Fighting Blindness and the federal
government. Currently, only a fraction of the research needed to make
treatments and cures a reality is funded.
FISCAL YEAR 2002 FUNDING REQUEST
We urge your continued commitment to the congressional campaign to
double the NIH budget by fiscal year 2003. We strongly support the
recommendation of the Ad Hoc Group for Biomedical Research Funding
calling for a $3.4 billion, or 16.5 percent, increase for NIH in fiscal
year 2002. This request represents the necessary funding level to
maintain the course towards the NIH doubling effort.
Within the context of the NIH budget, the National Alliance for Eye
and Vision Research and the Foundation Fighting Blindness request your
support for a budget of $620 million for the NEI in fiscal year 2002.
This funding level represents a $109.4 million, or 21 percent, increase
above the current year budget. This level of funding 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.
A fiscal year 2002 budget of $620 million also reflects the
professional judgment of the vision research community as 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. We 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.
Genetics and Gene Therapy.--Ongoing genetic studies are revealing
the normal function of genes and how those functions are impaired when
genes mutate which in turn will provide essential insight into many
types of vision dysfunction. Gene therapy holds great potential as a
therapeutic strategy to halt the progression of many forms of blinding
eye diseases, including macular degeneration, retinitis pigmentosa, and
glaucoma. Gene therapy has already proven to be successful in
preventing vision loss and restoring sight in rodent models of
retinitis pigmentosa.
Tissue and Cell Transplantation.--NEI-sponsored scientists are
determining whether transplanting healthy cells into the retina might
lead to new treatments for people with blinding eye diseases, such as
diabetic retinopathy, glaucoma and age-related macular degeneration--
the leading cause of blindness in the United States.
Drug Therapy.--A new therapeutic drug developed may be important in
treating blindness in human caused by diabetic retinopathy or macular
degeneration. Vessels that grow abnormally in the eyes can leak fluid
or blood, causing rapid and severe vision loss. This new drug, PKC 412,
blocks new abnormal vessel growth and has no apparent adverse effects
on normal vessels. More tests are needed to determine whether the drug
is a viable, effective alternative in the treatment of diabetic
retinopathy.
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 Photoreceptors in Retinal Degenerative Diseases: A number
of research advances now support the development of strategies
for preventing or slowing down photoreceptor degeneration in
retinal degenerative diseases. There are numerous opportunities
for basic research in this area, as well as opportunities for
translating these research advances to patient care. A number
of approaches show promise, including the use of growth
factors, transplantation, and molecular and genetic
technologies.
--Survival of Retinal Ganglion Cells: 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. NEI-supported scientists are also conducting
research to improve the understanding of the nature and course of
glaucoma, incorporating studies of co-morbidity, natural history, and
genetics with special emphasis on Hispanic, Native American, and
African-American populations.
Resources for Research on the Visual System.--In order to better
understand the molecular and genetic basis for diseases of the eye and
disorders of vision, it is essential that research be conducted to
identify and sequence genes that are expressed in the visual system.
There are a number of projects which could be pursued much 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 the 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 which
cause visual impairment in adults are AMD, cataract, glaucoma, diabetic
retinopathy, and optic nerve atrophy. Even more serious are the eye
diseases which cause visual impairment in children. These include
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.
By the year 2030, the NEI estimates that the elderly population in
the United States will double and more than 66 million Americans will
be at risk for blinding eye diseases. If we do not make significant
investments in vision research, we will have both an economic and
health care crisis in this country, given our nation's demographics.
With increased support for the NEI, we can make treatments for many
vision diseases and disorders happen within our lifetime.
Conclusion.--Mr. Chairman, the members of the National Alliance for
Eye and Vision Research and the Foundation Fighting Blindness are
supportive of an increased research focus on eye and vision disorders
that improves the quality of life for all Americans by allowing
individuals to remain independent and lead productive, fulfilling
lives. We urge the Subcommittee to provide a total NEI budget of $620
million, or a 21 percent increase in fiscal year 2002. In this new
millennium 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 for allowing the National Alliance for Eye and Vision
Research and the Foundation Fighting Blindness to present their views.
______
Prepared Statement of the National Alopecia Areata Foundation
Chairman Specter and Members of the Senate Appropriations
Subcommittee on Labor, Health and Human Services, Education and Related
Agencies, I am Vicki Kalabokes, Chief Executive Officer of the National
Alopecia Areata Foundation (NAAF) for the past fourteen years. Before I
begin my testimony, I would first like to express to you my deep
gratitude for the Congress' on-going bipartisan support of research at
the National Institutes of Health (NIH), and most particularly for
their recent support of increased funding, via passage of the
Children's Public Health Act of 2000, for autoimmune disease research-
research that might not otherwise have been funded.
As a non-profit voluntary health agency, the National Alopecia
Areata Foundation is the largest organization in the nation dedicated
to supporting research and finding a cure or acceptable treatment for
alopecia areata, a common but mysterious and unpredictable autoimmune
skin disease resulting in hair loss. The Foundation also provides
emotional support for those with the disease through a publication
program, an annual conference, and support groups. The support groups
provide information and direction to thousands of people with alopecia
areata. As a lay organization and the nationwide center for those
affected by alopecia areata, the Foundation is often the first place,
outside of the medical community, that a person turns to for help and
information. Frequently people call who are scared, misinformed, and
afraid. The support groups provide a forum to reach out to others,
solve common problems and grow.
The National Alopecia Areata Foundation receives no federal grants
or subgrants, nor do we receive federal contracts or subcontracts. The
Foundation is also a member of, and the past headquarters for, the
Coalition of Patient Advocates for Skin Disease Research (CPA-SDR). The
Coalition, which operates as a voluntary organization and as such
receives no public or private money, provides an umbrella to over 25
``lay'' skin groups. These groups represent millions of people who
suffer from a wide range of skin diseases. We work together for two
reasons. First, to provide information to others about why research is
needed. And secondly, so that we may push for a wide ranging research
agenda. Recent research has demonstrated that diseases such as alopecia
areata, lupus, vitiligo and others are the result of a malfunctioning
immune system. When the key is found to one of our diseases, then it is
very likely that many of the other diseases represented in the
Coalition will be cured. By working together we can and will make a
difference.
Alopecia areata is an autoimmune skin disease that strikes over 4.5
million Americans. It results in the loss of hair. For the fortunate
few it is a quarter-size patch that can be easily covered, for many
others it is the loss of every hair follicle on their entire body. For
over half of the people with alopecia areata, it starts between the
ages of 5 and 9. It strikes members of all ages and ethnic groups;
males and females are equally affected. The loss of hair has several
types of impacts. Hair provides significant protection for the body.
The loss of eyelashes or nasal hairs means that even the simple acts of
opening and closing one's eyes, or breathing in or out, cannot keep
dust or foreign particles away. These natural physical acts become a
very difficult process.
However, alopecia is not simply a physical problem, it has
surprisingly serious psychological consequences. For many people, when
they first discover their hair falling out they are devastated. They
think that they are the only ones in the world with the disease.
Frequently when they go to their doctors they discover that even their
physicians have little idea of what is happening, why it is happening,
or even if others suffer from it. For some, treatment options stop at
that point, while for others, they begin the long process of finding
someone who knows something about the condition.
Unfortunately in our society the lack of information is not the
only problem. Frequently people with alopecia arata believe that they
are vulnerable to the stares and grimaces of those around them. People
have lost their jobs. A noted news anchor lost his on-air job because
he was suddenly perceived as being unappealing. This lack of being
appealing (either real or perceived) causes many people to lose
confidence in themselves and they begin to withdraw from society.
Recently, the Foundation received a call from a young woman who was
denied the ability to take her GRE (Graduate Record Examination) simply
because she arrived to take the test wearing a head covering. She was
sternly reprimanded and, without prior notification, was informed that
absolutely no hats or head coverings were allowed to be worn while
taking the exam. Her choice was either to remove her scarf and suddenly
expose her completely bald scalp, or to leave the room immediately and
forfeit taking the test. And in Washington D.C., a young child was
deprived of taking a school field trip simply because others feared his
hair loss was contagious. In the recent past, two parents called about
their children. These two girls, one 12 and the other 14 at the time,
were in the process of losing their hair. They stayed inside their
homes, fearing that going outside would lead to harassment, cruel
stares, and not-being accepted as normal. Sadly in this image-conscious
society, this is so often the case. It seems to be hardest on the
children, who are routinely teased and even shunted into special
education classes.
Fortunately, there are people who can help, and in many of our
support groups people learn how they can help themselves both
cosmetically and psychologically. They learn that they are not alone
and that they can do something about their sense of vulnerability and
isolation. But the real solution will be when we find a cure for
alopecia areata.
Over the past fifteen years the Foundation has raised and provided
nearly $2.5 million for research studies. Our privately funded research
grants have been studying the mechanisms of hair biology; the genetics
and functioning of the immune system; the etiology, genetics, clinical
presentation and therapies of alopecia areata, and the development of
non-human research studies looking for the cause of and treatments for
alopecia areata. One of NAAF's recent grant awards resulted in the
scientific demonstration that alopecia areata is indeed an autoimmune
disease. In addition, an association exists between alopecia areata and
numerous other autoimmune diseases such as vitiligo, thyroiditis,
Addison's Disease, Type I diabetes, and others. Obviously the potential
benefit from cross-over research is enormous.
Part of our research program is to continue to work with the
National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) to create a research agenda. In September 2000, NIAMS announced
the awarding of a disease registry on alopecia areata, a watershed
event in the history of alopecia areata research. This award of more
than $2.7 Million over five years will establish a research registry
consisting of five sites across the United States. This commitment by
NIAMS to the advancement of alopecia areata research creates an
enormous opportunity to further basic, clinical, and translational
studies in alopecia areata. It will provide an essential resource for
all investigators interested in studying alopecia areata and will
stimulate opportunities for additional research support from federal
and private sources. The monies from this grant will not go to NAAF,
but directly to the institutions of the investigators overseeing the
research at these five centers.
In 1990, 1994, and 1998, NIAMS and NAAF conducted three
international research workshops on what is known about alopecia
areata. One of the many results from these joint programs was that
NIAMS funded a significant study on the structure of the disease.
Another result was the discovery of animals with alopecia-thus NAAF was
able to support the first non-human host of the disease. Recent genetic
studies have revealed unique markers (HLA or histocompatibility
leukocyte antigens) on the surface of white blood cells in those with
alopecia areata, strongly suggesting the existence of both
susceptibility as well as severity genes. These findings are very
similar to what has been noted in HLA marker groups of those with other
autoimmune diseases.
We are now planning the Fourth International Research Workshop on
Alopecia Areata in 2002 in conjunction with NIAMS. This symposium, as
with the earlier meetings, will bring researchers, clinicians, and
patients together from around the world to study what progress has been
made and how new studies should be structured. The convening authority
of NIAMS is critical for this sharing of knowledge.
Working together in this unique private-public partnership is a
significant step towards finding a cure. We hope to continue this
relationship with NIAMS providing limited funds for critical studies,
while we continue to work to support the research effort as well. With
this partnership we have been able to sharpen the research agenda so
that we are looking at questions that are building on a wider and more
informed base of knowledge.
The National Alopecia Areata Foundation asks that you continue to
support NIAMS by increasing the overall budget of the National
Institutes of Health (NIH). The NAAF believes that we must sustain the
current level of increased commitment to the NIH. The NAAF joins the Ad
Hoc Group for Medical Research Funding, the NIAMS Coalition, and the
Coalition of Patient Advocates for Skin Disease Research in asking
Congress to support a 16.5 percent ($3.4 Billion) increase in the
budget of the NIH for fiscal year 2002. This increase would allow us to
get back on track to continue the bipartisan effort to double the NIH
budget by fiscal year 2003--a sentiment shared by the President, the
Congress and the American people.
Funding biomedical research through the NIH is today's investment
in America's future. The economic burden in the United States for
musculoskeletal and skin diseases is staggering. The annual cost for
medical care and lost wages resulting from skin diseases alone is
estimated to be $22.3 Billion, affecting over 65 million Americans. The
research for these diseases falls under the umbrella of NIAMS and
today's technology, like never before, has enabled us to understand,
treat and ultimately cure many of these devastating, chronic skin
diseases. Support for the NIH, and therefore NIAMS, is particularly
instrumental in unlocking the genetic mysteries of autoimmune skin
diseases such as alopecia areata.
Again, we are asking for an increase of 16.5 percent or $3.4
Billion. This increase would allow NIAMS to increase its ability to
continue to fund more research projects and support more programs that
will help these 65 million Americans who are impacted by skin diseases.
We also believe that work done in any of the disease areas represented
by the Coalition of Patient Advocates for Skin Disease Research, will
have a profound impact on the lives of the millions of those who suffer
from one or more of the diseases that NIAMS is charged with
investigating. We also believe that when a cure is found for any of
these diseases that there is a good chance that it will help in finding
a cure for many of the other skin diseases.
Again, thank you for your past support of medical research funding.
Thank you so very much for your time and concern.
______
Prepared Statement of the National Association of Anorexia Nervosa and
Associated Disorders
When a young woman starves to death in the midst of plenty; when a
young woman despairs of hope in trying to cope with a deadly illness at
age 32 after struggling to survive for 17 years; and when thousands of
people all across America strive to live, but are victims of insurance
discrimination, assistance and guidance are desperately needed. All of
these are recent documented cases of eating disorders. eating disorders
is the major illness in our nation which receives totally inadequate
support or funding.
Eating disorders are rampant in our society and have reached
epidemic levels. All segments of society, young and old, rich and poor,
both sexes and all races are impacted by eating disorders. These
illnesses, which include anorexia nervosa, bulimia and binge eating
disorders, ravage the lives of more than 8 million people in the United
States including seven million women and young girls. An estimated 6
percent of the individuals with severe eating disorders will die; a
higher mortality rate than for any other mental illness. For those who
remain ill the constant thoughts of food, weight, body and behaviors
distort body image and their thought processes to the degree that their
lives are centered in a kind of hell rather than in living.
Although eating disorders are so prevalent in society, neither the
federal government nor most states in the nation have adequate programs
or services to combat anorexia nervosa, bulimia or binge eating. There
are few programs to prevent or educate children and youths about eating
disorders in schools and colleges. Resources that public health
agencies and schools devote to the prevention of eating disorders are
negligible in comparison to the resources and attention that they give
to the prevention of other serious health problems such as drug and
alcohol abuse. At all levels, federal, state and local, a significant
commitment must be made to the prevention of these life-destroying
illnesses.
Children and adolescents are a critical target of these prevention
programs as eighty-six percent of individuals with eating disorders
report the age of onset by 20 years. Of these 43 percent were between
16-20 years; 33 percent between 11-15 years; 10 percent 10 years and
younger. Shockingly eating disorders have been found in children as
young as 5 years of age. Something must be done to save these children.
We request that a minimum of $10,000,000 be appropriated for the
development and implementation of comprehensive education and
prevention programs that promote healthy notions about emotional
development of self, nutrition, body development and growth through
educational wellness for all of America's school-aged children and
early identification of those at risk for eating disorders. The need
for the request is substantial as ANAD estimates that twelve percent of
high school students and ten to twenty percent of college students
suffer from an eating disorder.
Founded in Illinois in 1976, ANAD is the first national health
organization of its kind. Dedicated to education, awareness, prevention
and alleviating the effects of eating disorders, ANAD helps victims and
their families by providing hotline counseling, support groups,
referrals to health care professionals, information packets and
newsletters, along with education/prevention programs. The services are
offered free of charge and the programs developed are low cost. ANAD
also undertakes and encourages research, fights insurance
discrimination and dangerous advertising, and organizes advocacy
campaigns to protect potential victims of eating disorders. Prevention
and education about eating disorders are pivotal to ANAD's mission.
Each year our outreach programs touch the lives of tens of thousands of
people.
The causes of eating disorders are varied and have not been
thoroughly delineated, however issues of identity and self-esteem and
other psychological problems often underlie eating disorders. Societal
and cultural influences emphasize thinness and work simultaneously with
media and advertising campaigns to continually reinforce the message to
be thin. Unrealistic self-images often result. Individuals feel
vulnerable and powerless in relationship to the world at large and
eating disorders provide the illusion of being in charge of one aspect
of their lives, food.
Education and prevention programs which teach children the skills
needed to cope with the emotional complexities of life in a positive
and life and self affirming way are crucial. ANAD's theme of ``Accept
Yourself, Accept Others'' encourages people to make healthy choices,
build self-esteem and lead to healthier living practices. Teaching
proper nutrition alone is not enough as evidenced by a statement a
dietitian with an eating disorder once made. ``Through my training, I
can teach anyone the right diet for any condition . . . as to myself
none of that applies to me.''
Prevention programs and support services need not be expensive to
be effective as proven by ANAD's many successful programs and services.
Implementation of these programs will ultimately lead to an enormous
financial savings as it will reduce the number of victims who will need
expensive and lengthy medical and psychiatric care required to treat
serious eating disorders. In monetary terms the cost savings will be
enormous and in human costs, the savings will be immeasurable.
We also request the Senate to increase current funding by an
additional $10,000,000 for research into the causes and treatment of
eating disorders, and research evaluating the effectiveness of
different prevention, treatment and self-help support strategies. By
elucidating the causes of eating disorders the specific at-risk
population can be identified and helped prior to the life-destroying
effects of the illnesses taking hold on their lives. Deciphering the
role of genetics in determining who is at-risk for these disorders
would also be valuable in prevention and treatment of eating disorders.
This funding is essential to the development of truly effective
prevention programs and treatment strategies.
Furthermore, improving patients' access to quality, affordable
treatment through insurance reform and parity bills is vital. High
quality treatment is available, however many victims of eating
disorders are unable to access this treatment due to restrictions
placed on them by insurance companies. Concurrent medical and
psychological services are often necessary when treating people
suffering from eating disorders. Often, because eating disorders are
treated solely as a mental illness, patients are both denied the
medical treatment that they require and are subjected to the extremely
low caps on benefits for treatment of mental illness.
Action must be taken to change the uphill battle that victims of
eating disorders face when confronting insurance needs. On the
legislative front, proposals for insurance reform and health care
reform must ensure that patients with eating disorders can receive
reimbursement for both medical and mental health care. Government
funded mental health centers should be encouraged to develop
multidisciplinary approaches to the treatment of eating disorders.
We ask the Senate to help safeguard the rights of people with
eating disorders through reforms of the health care and insurance
systems. We also ask the members of this subcommittee and the Senate to
enact legislation that provides funding aimed at preventing another
generation of youth from developing eating disorders. This legislation
would also fund research into the causes of eating disorders which
would in turn strengthen the effectiveness of eating disorder treatment
protocols.
Thank you.
______
Prepared Statement of the National Association of Children's Hospitals
Mr. Chairman and Members of the Subcommittee, my name is Dr. Robert
Felter, and I am the Chairman of Pediatrics and Medical Director at Tod
Children's Hospital in Youngstown, Ohio.
I submit this testimony on behalf of the National Association of
Children's Hospitals in Alexandria, VA, in support of the Children's
Hospitals' Graduate Medical Education (GME) program in the Health
Resources and Services Administration. On behalf of the nation's nearly
60 independent children's teaching hospitals, I urge you to continue to
provide adequate funding for Children's Hospitals' GME so that these
institutions will have the resources to continue to train and educate
the nation's pediatric workforce.
BACKGROUND
The National Association of Children's Hospitals or ``N.A.C.H.'' is
a not-for-profit trade association, representing more than 100
children's hospitals across the country. Its members include
independent acute care children's hospitals such as Tod Children's
Hospital, as well as children's hospitals in Akron, Cincinnati,
Cleveland, Columbus and Dayton; acute care children's hospitals
organized within larger medical centers, such as Kosair Children's
Hospital in Louisville, KY; and children's specialty and rehabilitation
hospitals, such as the Hospital for Sick Children in Washington, DC.
N.A.C.H. seeks to serve its member hospitals' ability to fulfill
their four-fold missions of clinical care, education, research, and
advocacy devoted to the health and well-being of children. Children's
hospitals are regional and national centers of excellence for children
with serious and complex conditions. They are centers of biomedical and
health services research for children, and they serve as the major
training grounds for future pediatric researchers, as well as a
significant number of our children's doctors. These institutions are
advocates for the public health of children, and they are essential to
the health care safety net for children of low-income families.
While they account for less than 1 percent of all hospitals, the
independent children's hospitals train nearly 30 percent of all
pediatricians and nearly half of all pediatric specialists, and they
are the major producers of future pediatric researchers.
Independent children's teaching hospitals are experiencing very
serious financial challenges that affect their ability to sustain their
missions. In addition to the challenges of covering the costs of their
academic programs, they include challenges in covering the higher costs
of sicker patients in a price competitive marketplace, meeting the
costs of uncovered services such as child protection services and
poison control centers, and assuming the costs of devoting a large
portion of their patient care to children from low-income families.
On average, independent acute care children's hospitals devote
nearly half of their patient care to children who are assisted by
Medicaid or are uninsured. They devote more than 75 percent of their
care for children with one or more chronic or congenital conditions.
For children with rare and complex conditions, independent children's
hospitals often provide the majority of care in their region or even
nationwide.
Left unresolved, children's hospitals' financial challenges will
seriously affect not only their academic programs of education and
research but also their clinical care missions as safety net providers
and centers of excellence. In fact, their roles as safety net providers
and centers of excellence are made possible in part by their having
strong academic programs.
ISSUE OF CONCERN
The issue of concern to NACH, which brings me here today, is that
independent children's hospitals have faced serious financial burdens
and competitive disadvantages in recent years, because they receive
virtually no GME support through Medicare--the only source of
significant and stable GME support available to teaching hospitals.
Because children's hospitals do not care for the elderly, they have few
(if any) Medicare patients and thus receive less than 0.5 percent or 1/
200th of the federal Medicare GME support provided to other teaching
hospitals.
In recent years, while the Medicare program was spending about $7
billion annually on GME programs at over 1,000 teaching hospitals
across the nation, children's hospitals received less than $2 million
in federal support for their continuing education programs. The Lewin
Group, an independent health policy analysis firm, calculated in 1998
that independent children's teaching hospitals should receive
approximately $285 million in federal GME support for nearly 60
institutions to achieve parity with the financial compensation provided
through Medicare for GME support to other teaching hospitals.
In the absence of any movement towards broader GME financing
reform, Congress enacted the Children's Hospitals' GME discretionary
grant program to address the existing inequity and ensure that these
institutions could receive equitable federal support to sustain their
teaching programs. The pediatric community, including the American
Academy of Pediatrics, Association of Medical School Pediatric
Department Chairs, and others, recognize the critical importance of the
GME programs of the independent children's teaching hospitals, not only
to the future of the individuals hospitals and their essential services
but also to the future of the nation's pediatric workforce and
pediatric research overall.
In fact, after three years of work assessing the needs of pediatric
education in the next decades, the leadership of the pediatric
education community last year issued 34 recommendations, including a
recommendation for equitable GME support for independent children's
teaching hospitals. The Future of Pediatric II (FOPE II) Task Force
said: ``Pediatric residents and fellows at freestanding children's
hospitals should receive the same level of federal support as those
trained elsewhere.''
CONGRESSIONAL RESPONSE
The 106th Congress recognized the pressing need to provide
independent children's teaching hospitals with the same federal support
for their teaching programs that they provide to all other teaching
hospitals through Medicare by taking action on two fronts:
First, Congress has both authorized and reauthorized the program.
In November 1999, with broad bipartisan support, Congress authorized
$285 million for the Children's Hospitals' GME Program in fiscal year
2001 as part of the ``Healthcare Research and Quality Act of 1999.'' In
September 2000, Congress reauthorized the program through fiscal year
2005 at ``such sums as necessary'' as part of the ``Children's Health
Act of 2000.'' Congress passed both the authorization and
reauthorization bills by unanimous consent.
Second, and more importantly, Congress appropriated $235 million
for Children's Hospitals' GME in the Fiscal 2001 Labor/HHS/Education
Appropriations bill as a specific line-item within the Health Resources
and Services Administration (HRSA) account. Last year's funding was a
significant increase over the fiscal year 2000 funding of $40 million--
an initial funding level provided for the program before it was
authorized.
The $40 million appropriated in Fiscal 2000 was distributed through
HRSA to 57 children's hospitals according to a formula based on the
number and type of full-time equivalent (FTE) residents trained, as
well as the complexity of care and intensity of teaching the hospitals
provide. HRSA will soon be finalizing the process of distributing $235
million in Fiscal 2001 funding to children's hospitals to cover a
higher percentage of the costs associated with their GME programs.
IMPACT ON TOD CHILDREN'S HOSPITAL
Tod Children's Hospital, which is part of Forum Health, is a 97
bed-facility that serves as a regional referral center, delivering care
to children in northeastern Ohio and western Pennsylvania, with more
than 30 subspecialties and a number of specialized programs, such as a
children's emergency center and a pediatric inpatient cancer unit. We
serve all children, devoting more than 60 percent of our care to
children who are assisted by Medicaid or uninsured.
Tod Children's Hospital also is a teaching hospital, training 27
resident FTEs, including 24 in pediatrics and three in medicine and
pediatrics. Despite the small size of our training program, it has an
enormous impact on the availability and quality of health care for
children in the Youngstown area. The majority of our residents go on to
practice in Ohio, and in the last six years, more than 40 percent went
on to practice in Youngstown. Today, 50 percent of pediatricians
practicing in Youngstown were trained at our hospital.
Youngstown is an economically depressed community, which makes it
hard to attract strong, clinical talent to come to and stay in our
area. Without our training program, the pediatric workforce of
Youngstown would be seriously affected. And without our training
program, our ability to maintain a children's hospital and its
substantial contribution to the quality of care for all of the children
of our region would also be seriously challenged.
Clinical care and residency training go hand in hand. A strong
training program contributes to a strong clinical program, and a strong
clinical program contributes to a strong training program. Our hospital
spends more than $2 million to cover the direct costs of our GME
program, which represents a major expense for our institution. As a
consequence, every year our hospital faces difficult financial
tradeoffs as we struggle to balance our commitments to training and
clinical care. Even with the GME funding our hospital received as a
result of the fiscal year 2000 appropriation, Tod Children's could not
sustain is residency training program without cutting our family-based
HIV clinic serving infected children and their mothers and scaling back
our child-life program. These kinds of financial decisions are not easy
to make. However, with equitable GME support from the federal
government--comparable to what other teaching hospitals receive--our
hospitals will be able to cover the added costs that result from their
teaching missions while being able to provide other important programs
and services that affect the health and well being of the children of
our region.
The significant increase in funding we project to receive from the
fiscal year 2001 appropriation is absolutely vital to our residency
training program, our hospital, and our community. Without it, the
future of our training program will be in jeopardy, and that in turn
will put in jeopardy the long-term future of our children's hospital
and the health of the children of our community.
With such a major impact on a small institution like Tod Children's
and our community, you can imagine the magnitude of the impact that
Children's Hospitals' GME funding will have on much larger institutions
and their regions--Children's Hospital Boston with 238 resident FTEs,
Children's Hospital of Michigan with 160 resident FTEs in Detroit, or
Children's Hospital Medical Center in Cincinnati with 153 resident
FTEs.
FISCAL 2002 NEED
I am here to impress upon you that adequate funding for Children's
Hospitals' GME is an ongoing need. Our institutions continue to train
new pediatric residents and researchers every year. While we have
appreciated very much the Congressional support--particularly with the
funding provided in Fiscal 2001--we have received, the teaching mission
carried out by children's hospitals will not end this year. Now, we
seek to achieve full parity with other teaching hospitals for federal
GME support, which will require the full authorization of $285 million
for Fiscal 2002.
In order to make children's health a top priority for our country,
Congress should appropriate the fully authorized funding level of $285
million for Children's Hospitals' GME in Fiscal 2002. These funds will
ensure that independent children's hospitals receive the resources
necessary to continue to train and educate the nation's pediatric
workforce and sustain their core missions, including clinical care and
research.
Support for a strong investment in GME at independent children's
teaching hospitals is consistent with the repeated concern the
Subcommittee has expressed for the health and well being of our
nation's children--through education, health, and social welfare
programs. It also is consistent with the Subcommittee's repeated
emphasis on the importance of enhanced investment in the National
Institutes of Health (NIH) overall, and in NIH support for pediatric
research in particular, for which we are very grateful.
Finally, support for this program is a strong investment in cost
effective health care. Please remember that prevention is the core of
pediatrics. We train every pediatrician to specialize first in primary
and preventive health care, which maximizes children's long-term health
and reduces the long-term cost of their care, not only as children but
also as adults. As a result, it's an investment in the future health of
everyone. The children we care for today may be only 25 percent of our
population; but tomorrow, they will be 100 percent of all adults.
______
Prepared Statement of the National Association of Developmental
Disabilities Councils
The National Association of Developmental Disabilities Councils is
a national organization representing Developmental Disabilities
Councils in thirty-nine states and territories. Combined with the
Councils represented by the Consortium of Developmental Disabilities
Councils, there are a total of 55 Councils--one in each State, the
District of Columbia, and the territories of American Samoa, the
Commonwealth of the Northern Marianas Islands, Guam and Puerto Rico.
NADDC provides leadership to member Councils to support their work for
change on behalf of individuals with developmental disabilities and
their families. On the national level we support policies that enhance
the quality of life for all people with developmental disabilities--
individuals who experience a severe, chronic disability which occurs
before the age of 22 and results in substantial functional limitation
in three or more areas of major life activity (self-care; receptive and
expressive language; learning; mobility; self-direction; capacity for
independent living; and economic self-sufficiency).
Council activities are authorized through the Developmental
Disabilities Assistance and Bill of Rights Act (Public Law 106-402).
The ``DD Act'' was originally enacted in 1963 as the Mental Retardation
Facilities and Construction Act in response to the need for
alternatives to large institutions. It has been expanded to meet the
growing needs for community supports with each subsequent
reauthorization. In addition to the State Councils on Developmental
Disabilities (Part B of the Act), the Act also provides authority for
funding in each State and territory for a statewide Protection and
Advocacy System and a University Center for Excellence in Developmental
Disabilities Education, Research and Service (formerly the University
Affiliated Programs).
The Governor in each State and territory appoints members of State
Councils. Sixty percent of the Council membership must be people with
significant disabilities and their family members. The rest are state
agency administrators, private providers, and members of the community.
Together this group develops and implements a statewide plan which lays
out activities to enhance the lives of people with developmental
disabilities through a variety of systemic change, capacity building
and advocacy activities. The Councils' plans promote a comprehensive
system of services and supports designed to increase the independence,
productivity, inclusion, integration and self-determination of
individuals with developmental disabilities. Federal funding for these
activities is administered by an agency also designated by the
Governor.
Flexible systems based on individual empowerment and self-
determination that require partnerships between the professional and
the consumers have proven to be the key ingredients for the successful
promotion of the goals expressed in the DD Act. Unfortunately, systems
change is difficult and state systems for developmental disabilities
were designed years ago to ``treat'' rather than partner with the
individual receiving the service. The Councils have a key role to play
in bringing changes about in ways that can positively impact
individuals with developmental disabilities.
To assist States, the Act lists a number of ``areas of emphasis''
for Council activities. Councils can choose to work on issues related
to quality assurance, childcare, housing, transportation, recreation,
education, employment, health, and formal and informal community
supports. They are required to strengthen, support and expand
opportunities for individuals with developmental disabilities to
receive and provide leadership training and to work in coalitions. They
are also free to establish priorities outside of those prescribed in
the Act to meet the unique needs of individuals with developmental
disabilities in their own State or territory.
While Councils are not service providers, one of the ways that we
are able to advance change is through direct support of best practice
activities. One of the more recognized activities of the State Councils
are grants to public and private agencies that support system change
projects, demonstrating at the local level that there is a better way
to provide services to individuals with disabilities. Because there are
too few quality community services for people with developmental
disabilities, the Councils have taken on the responsibility of
assisting grantees seek new State, local, and private sector funds to
support these activities. Preliminary data for fiscal year 2000
indicates that in this way Councils helped leverage far more in state,
local and private funds for services and supports than the taxpayer
invested in the four DD programs combined at the Federal level.
DD Council work goes far beyond service system improvement into new
areas of community development that improve the lives of everyone--
including people who do not have disabilities. Realizing that people
are best protected and included in their communities if their lives are
intertwined with families, neighbors, friends and co-workers, DD
Councils also work on community and economic development so that all
citizens share in the resources communities have to offer. It is clear
that if we want people with disabilities to have competitive jobs and
life-long careers, we must invest in the economic vitality of our
communities: poverty-stricken communities result in poverty for people
with disabilities. If we want people with disabilities to live safe and
healthy lives, we must invest in affordable housing initiatives for
them and their neighbors: slums and homelessness are bad for everyone.
If we want children with disabilities to attend school with their non-
disabled peers and become productive, civic-minded adults, there must
be quality education for all children. If we want people with
disabilities to be included in our communities, we must have
communities that appreciate and believe in the equality of all people.
For all of these reasons, Councils are viewed as invaluable change
agents in the States and have made a significant difference in the
lives of individuals and their families across the nation. Best
practices promoted by Councils have resulted in, among other
accomplishments, strong early childhood programs; improvements in
school services; access to real, inclusive jobs through supported
employment; small business ownership; training and empowerment of self-
advocates; means to address the crisis in the shortage of qualified
direct care professionals; home ownership; accessible transportation
systems; appropriate community activities for individuals with
developmental disabilities as they become older; and tremendously
important supports for families so they can remain healthy and intact.
In keeping with changing times, Councils across the country are now
called on to address burgeoning community waiting lists; to plan for
the huge demands that will be placed on services by the aging baby boom
generation--including the loss of a large percentage of the service
provider population as they reach retirement; and to face the
challenges of abuse and neglect in a wide range of settings.
A sampling of activities across the country should be helpful in
understanding the importance of the Developmental Disabilities Councils
in each State. To give the big picture would take volumes, but the
following provides a glimpse into some of the State Councils list of
achievements.
--The DD Council in Ohio developed a self-determination initiative
that has proven so successful that it has been adopted by the
State Department and has spread to 30 out of the 88 counties.
This effort continues to grow through the State, resulting in
more control for individuals with developmental disabilities
over their own lives.
--Through a grant with Very Special Arts of Idaho (VSAI) the Idaho
Council is assessing the accessibility of arts, leisure, and
recreational facilities and programs across the state.
--In Iowa the DD Council working in coalition with other like-valued
groups was successful securing all of the state's Tobacco
Settlement Fund ($55 million) for purposes related to health
care and the needs of children, adults and families, with a
strong focus on special needs.
--One hundred and sixty individuals with developmental disabilities
in Mississippi became employed in their communities as a result
of the DD Council's activities in that state. One hundred and
fifty eight businesses employment people with developmental
disabilities, and 630 people were trained in the Person
Centered Planning process.
--Housing shortage issues are tackled head-on by a number of
Councils. One initiative in New York uses a low income housing
tax credit designed to encourage private sector investment in
the production of low-income housing. The program allows the
owner/developer of a qualified property a dollar-for-dollar
credit claimed over an extended period of time to equal an
established share of the property's construction costs.
--The Maryland Council has led a statewide, cross-disability
initiative to expand homeownership opportunities to low-income
people with significant disabilities. This work has resulted in
the state's commitment of $8.2 million in mortgage funds. The
program received a HUD ``Best Practice'' award in 1999.
--In North Dakota public transit services, when available, are not
fully accessible. Thanks to start-up funding provided by the DD
Council, the cities of Mandan and Bismarck have been able to
address transportation needs for people with disabilities in
these cities by combining formerly fragmented and autonomous
transit programs into a consolidated, accessible community-wide
public transportation system. Without access to this system
riders with disabilities would not be able to realize
employment ambitions, shop for necessities, achieve
independence or experience general community involvement and
participation.
--The South Carolina DD Council is active in developing and
monitoring a universal newborn hearing screening program
required on all newborns in the State. The program is designed
to detect hearing impairments in infants. With early detection
and intervention children are more likely to experience normal
language development.
--The Community Self-Employment Program in Arkansas resulted in a
number of new entrepreneurs in the state--business owners who
experience a disability. The project was designed to provide
loans to assist and support individuals in ownership and
operation of their own business. Businesses included include
Web-site designing, a concession business, a recycle shop for
computers and business machines, legal abstracting, Web
marketing, and a pizza store.
--The DD Council has a long history of leading systems change efforts
in Hawaii. Among its accomplishments are the closure of Waimano
Training School and Hospital, the state institution for people
with mental retardation, and the successful integration of
those residents into the community. The Council also played a
key role in the development of state legislation that created
the nation's first statute codifying self-determination for
persons with developmental disabilities (Act 133, 1998).
--With an initial start-up grant in 1996 of $124,000.00 for the Home
of Your Own Program, the Nevada DD Council has leveraged more
than $3 million in non-HOYO funding to provide first time home
ownership to 51 Nevadans with disabilities. Through a
partnership with Accessible Space, Inc. and the Office of
Community Based Services, the Council with initial funding of
$250,000.00 has leveraged over $24 million in HUD funding to
build 4 affordable, accessible assisted living apartment
buildings for Nevadans with severe disabilities and has HUD
funding approved to build 2 more such apartments.
--The New Hampshire Council has done significant work in voter
access, giving rise to national attention to voter access
issues through work with state and national election officials.
The Council published and widely disseminated a voter manual.
The Council in New Hampshire has also taken the lead in work
incentives activities in their state. They have facilitated a
statewide effort to coordinate the integration of three federal
grants to implement the Workforce Investment Act and other
employment initiatives with the Governor's Task Force on
Employment and Economic Opportunities.
Every Council has to set priorities identified at the State level
and hard choices have to be made. Unfortunately, there are many more
critically needed infrastructure activities than DD Councils alone can
generate funds to address. In our public testimony last year we listed
some of these needs. Regrettably, they have not changed.
--Direct Care Staff--The need for additional direct care staff
continues to be at a crisis level in most of our communities.
We cannot train front line personnel rapidly enough. We know
that properly trained staff on the day-to-day firing line can
spot abuse and neglect and take immediate action to stop such
incidents and prevent any repetition. High turnover rates and
poor compensation are significant challenges to our services
system. If these issues are not addressed, we will see
individuals with developmental disabilities lose their newfound
independence.
--Inclusive Child Care--There is a well-documented shortage of
quality childcare for working parents. This is an even more
serious problem for parents of children with disabilities who
do not want their children segregated from their non-disabled
peers--for parents who want their children in childcare
settings that welcome all children.
--Transportation System Redesign--One of the major blockades for
individuals with disabilities who wish to work but who require
special transportation accommodations is the lack of such
accommodations. The lack of affordable, accessible
transportation is often identified as the single most constant
problem faced by individuals with developmental disabilities in
achieving employment and community life.
These are examples of some of the issues that remain largely
untouched by Council advocacy due to the lack of funding. This list
will grow as the Councils take on the new activities Congress included
for the DD Councils in the Act last year. The law now includes a role
for the Councils in addressing issues of: (1) aging parents of adult
sons and daughters with developmental disabilities; (2) waiting lists;
(3) abuse and neglect; (4) inappropriate restraints; (5) development of
person-centered quality assurance systems; and (6) increased emphasis
on self-advocacy.
There are high expectations of Councils in every State, and DD
Councils have demonstrated that they get results and are a bargain for
the federal tax dollar. DD Councils are taking a significant next step
to build communities that work for everyone, including people with
developmental disabilities, in addition to their work to improve the
service system. Because they do not provide services and can act
independently of the service system, the voice of the DD Council has
proven to be critical in each State and territory to the lives of
people with developmental disabilities and their families.
Unfortunately, the current reach of the State Councils is far
smaller than it could be, given adequate funding. The two tables
appended to this statement reflect a seven-year funding history for the
DD Councils. It is notable that funding was cut by 8 percent in fiscal
year 1995 and has yet to return to the fiscal year 1995 level. Councils
are not able to keep pace with the growing needs in every State. With
the fiscal year 2001 Federal investment in Council activities of $67.8
million, the smallest 14 states receive $420,000 and the average
allocation is less than $1 million, far less than needed keep pace with
the cost of living, let alone to fulfill the promises of the DD Act,
including the requirements added in the recent reauthorization. The
lack of adequate funding has made it difficult to advance the
independence and inclusion of individuals with significant disabilities
in every State.
To remedy this shortfall, the National Association of Developmental
Disabilities Councils (NADDC) urgently recommends an appropriation of
$85 million for DD Councils. This represents a restoration of the
fiscal year 1995 cut, CBO cost of living percentage increases for the
past 5 years, and an additional $3 million for new requirements. Our
sister programs, Protection and Advocacy Systems and University
Affiliated Programs have also languished since 1995 with insufficient
funding and NADDC recommends $35 million for P&As and $28.5 for UAPs.
For Projects of National Significance, the only national research and
development program targeted especially to individuals with
developmental disabilities, including the Family Support Program, we
recommend $16 million. This totals $164.5 million the DD Act programs
need to keep up the momentum and to launch the necessary changes in the
new century.
______
Prepared Statement of the National AHEC Organization
Mr. Chairman, and members of the subcommittee, I am pleased to
present testimony on behalf of the National AHEC Organization.
I am Project Director at the Northeastern Ohio AHEC, located in
Rootstown, and a member of the National AHEC organization. We are a
professional organization representing the Area Health Education
Centers (AHECs) and Health Education and Training Centers (HETCs).
Together, we seek to further the AHEC mission; to enhance access to
quality health care, particularly primary care and preventative care,
by improving the supply and distribution of health care professionals
through community and academic/educational partnerships. Health
Education and Training Centers (HETCs) have a similar mission to AHECs,
but are unique in their focus on public health matters associated with
areas found along our nation's border with Mexico, the State of
Florida, and other extremely underserved areas within our country.
WHAT AHECS DO
Since our inception almost thirty years ago, AHECs, in partnership
with local/state/federal initiatives and educational institutions, have
provided clinical training opportunities to health professions and
nursing students in underserved communities and have extended the
resources of academic health centers to these locations. Currently,
there are 40 AHEC programs and more than 160 AHEC centers.
AHEC programs concentrate on four areas:
--Developing health care recruitment/preparation programs in
underserved areas for underrepresented and disadvantaged
students. These efforts provide hands on science and math
instruction and exposure to local health professionals. Not
only is this an educational opportunity, but an encouragement
for young people to enter health professions careers.
--Oversee the community based training of primary care health
professions students and residents in health professions
shortage areas. AHECs are pioneers in the effort to train
residents in a community based setting. The contribution of
this type of training is immense to the healthcare workforce.
It allows for individuals to complete their education in the
locale they will serve. In 1998, AHECs provided community based
training to approximately 15,000 health professions students in
underserved areas.
--Provide information, support, and technical assistance to health
care professionals to ensure an opportunity for continuing
education. In 1999, AHECs provided Continuing Education
Programs for 174,425 participants.
--Promote healthy lifestyles in a manner which is appropriate to
specific community and population needs.
AHEC's play a vital role in integrating community needs,
educational resources, and health professionals. An example of this
effort is the Canton Area Regional Health Education Network, an AHEC
Center, which operates a primary care project in partnership with the
Kent State College of Nursing. Primary health care nurse practitioners,
medical students, and allied health students provide a broad range of
care; screening for disease, education, and follow-up care, to migrant
workers. Initially, this was limited to adults, but has since expanded
to include immunizations and primary care for children, as well as
women's health services.
THE ROLE OF HEALTH EDUCATION AND TRAINING CENTERS (HETCS)
The HETC programs are a subset of the National AHEC program,
created with the purpose of improving the number and placement of
health professionals along the border between the United States and
Mexico, the State of Florida, and other areas of extraordinary need.
Like AHECs, the cooperation between faculty, students, and communities
serve as the base for HETC development.
In the state of Kentucky, in one year, over 6,000 disadvantaged
students were involved in programs focusing on healthy lifestyles,
violence prevention, and dental health. This was achieved through
partnerships among local schools, community centers, Boy's and Girl's
Clubs, and HETCs.
JUSTIFICATION FOR FUNDING RECOMMENDATIONS
Mr. Chairman, I respectfully ask the Subcommittee to support our
recommendations of increasing the funding for the health professions
and nursing education programs under Title VII and Title VIII of the
Public Health Service Act to at least $440 million. This is consistent
with the funding level recommended by the Health Professions/Nursing
Education Coalition.
A 20 percent increase for the AHEC and HETC programs is needed for
fiscal year 2002. Last year, no new AHEC programs were started. To
enable AHEC programs to expand service to states that currently have no
program and strive towards completing a 50 state network, additional
funding is crucial. AHEC programs have a multitude of responsibilities,
from recruitment of minority and disadvantaged students into health
professions careers, to enhancing the quality of the health care
workforce through telecommunications training, telemedicine, distance
learning, and providing health career experience to K-16 students.
HETCs provide training experiences for health professions students
and local providers at sites of severe underservice to improve access
to health care, diversity and cultural competence of the healthcare
workforce. One out of five U.S. citizens live in a border HETC county.
Within these areas, only 62 primary care physicians per 100,000 reside
in border counties compared to 105 per 100,000 nationally. To help
alleviate this situation, each HETC project supports at least one
training and education program for physicians and one for nurses so
that a portion of the clinical training for students is in the service
area.
Mr. Chairman, thank you for the opportunity to present the views of
the National AHEC Organization. We look forward to working with you and
your staff. I would be happy to answer any questions that you or your
colleagues may have.
______
Prepared Statement of the National Center for Victims of Crime
The National Center for Victims of Crime is the nation's leading
nonprofit advocacy and resource organization serving victims of all
crime. Since its founding in 1985, the National Center has worked with
nearly 10,000 public and private non-profit organizations and agencies
across the country, and has provided information, support, and
technical assistance to hundreds of thousands of victims, victim
service providers, allied professionals, and advocates.
One of the highlights of the Violence Against Women Act of 2000
(VAWA II) was the increased resources to support rape prevention and
education. This money funds the rape crisis centers nationwide that
provide support, counseling, community outreach, and education
activities that are the nation's best hope for making inroads against
this terrible crime.
While advocates cheered to see the increase as part of VAWA II, the
President's fiscal year 2002 Budget proposes retaining the previous
funding levels. Rather than the $80 million authorized, the
Administration proposes funding this important program at $45 million.
We call on this Subcommittee to fully fund this important program.
THE IMPORTANCE OF RAPE EDUCATION
The incidence of sexual assault in this country remains high;
despite an overall drop in crime rates, there was a 20 percent increase
in rapes, and a 33.3 percent increase in sexual assaults in 1999.\1\
Rape prevention and education efforts are key to ending sexual
violence, by changing attitudes about rape and ending the isolation of
victims.
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\1\ Rennison, Callie M. (August 2000). Criminal Victimization 1999:
Changes 1998-99 with Trends 1993-99. Washington, D.C.: Bureau of
Justice Statistics, U.S. Department of Justice, Table 1.
---------------------------------------------------------------------------
In the National Center's 1992 landmark study, ``Rape in America: A
Report to the Nation,'' sexual assault victims were asked about the
extent to which they were concerned about issues specific to their
personal rape experiences. Rape victims reported that they were
concerned about:
--her family knowing about the assault (71 percent);
--people outside her family knowing she had been sexually assaulted
(68 percent); and
--people thinking it was her fault or that she was responsible (69
percent).\2\
---------------------------------------------------------------------------
\2\ National Victim Center & Crime Victims Research and Treatment
Center. (1992). Rape in America: A Report to the Nation. Arlington, VA:
National Victim Center. P. 4.
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This combination of concerns may explain why so few rape victims
report their assaults. The Rape Prevention and Education Grants
represent the best opportunity for change.
Rape education changes attitudes; it is a direct response to the
problem of victim blaming which allows sexual violence to fester.
Victims blame themselves: ``If only I hadn't . . .'' Their friends and
family often judge them: ``Why didn't she . . .?'' It is only by
education that victims will stop blaming themselves and society will
stop blaming the victims. It is only through education that blame can
be shifted back where it belongs: to the offender.
When that happens, victims will be more willing to reach out to the
services they need. Indeed, rape crisis centers around the country
report that following public awareness and education activities, more
victims come forward to seek help. This serves as a concrete indication
of the importance of such education and outreach efforts.
THE CONNECTION BETWEEN EDUCATION AND PREVENTION
Education about rape can prevent rape. As young people become aware
of the frequency of acquaintance rape, they broaden their efforts to
protect themselves from merely locking doors against strangers to
taking precautions with those they know. Education is also key to
reducing drug-facilitated sexual assault. As detection and prosecution
remains difficult, the best means to reduce such crimes is prevention
through education. Through education and public awareness efforts,
young people can learn to reduce their risk, and understand the warning
signs that they or a friend may have ingested Rohypnol, GHB, or other
drugs commonly used to facilitate sexual assault.
As noted above, education also fosters requests for assistance.
This, in turn, leads to prevention of future assaults by reducing
repeat victimization. In 1998, the Canada Solicitor General found that
sexual assault victims are thirty-five times more likely to be re-
assaulted than individuals who were never assaulted.\3\ As education
prompts victims to seek services, they will get the support to reduce
their likelihood of revictimization. As one rape crisis director
recently stated, ``We have the opportunity in rape crisis agencies to
explain to [victims] their risks and offer support to help them
decrease their vulnerability in a blameless manner.'' Thus, there is a
direct connection between rape education and rape prevention.
---------------------------------------------------------------------------
\3\ Canada Solicitor Genera. (1998). Multiple victimization
(Canadian Urban Victimization Survey Bulletin No. 10). Ottawa: Ministry
of the Solicitor General.
---------------------------------------------------------------------------
PURPOSES OF FUNDING
As newly expanded under the Violence Against Women Act of 2000,\4\
rape prevention and education money can be used for:
---------------------------------------------------------------------------
\4\ Part of the Victims of Trafficking and Violence Protection Act
of 2000 (H.R. 3244).
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--educational seminars;
--operation of hotlines;
--training programs for professionals;
--preparation of informational material;
--education and training programs for students and campus personnel
designed to reduce the incidence of sexual assault at colleges
and universities;
--education and training to increase awareness about drug-facilitated
sexual assault; and
--other efforts to increase awareness about, or to help prevent,
sexual assault, including efforts to increase awareness in
underserved communities and awareness among individuals with
disabilities.
These are important efforts, that deserve to be fully funded. The
lack of such full funding directly impacts the ability of state and
local organizations to reduce rape in America.
From its conversations with sexual assault coalitions nationwide,
the National Center has learned of the dire need that exists for these
prevention and education funds. As examples:
--Approximately one out of six sexual assault programs in the
National Center's referral database does not have a 24-hour
toll-free hotline. In some states, there is no hotline, and for
centers that cover large geographic areas, calling the center
may cost the victim and be reflected on the victim's phone
bill, violating her confidentiality.
--In Alabama, less than half of the 15 rape crisis centers have a
full-time outreach staff member. None of the programs have
translated materials, and only two have a bilingual staff
member.
--Arkansas has no statewide sexual assault hotline, and no translated
materials or translators in sexual assault programs.
--In California, of 92 rape crisis centers, only 25 have translated
materials.
--Of Georgia's 21 rape crisis centers, only four have translated
materials and 4 have a bilingual staff member. Furthermore,
while the state has a law mandating sexual assault education in
the schools, 50 counties have no rape crisis program to provide
this education, and the programs that do exist consistently
turn away requests for presentations due to lack of staff.
--Mississippi has nine rape crisis centers, but because of a lack of
funds, two-thirds have no community outreach program. The state
coalition has received requests to provide training regarding
drug-facilitated sexual assault, but has not had the money to
develop such training.
--Ohio estimates that of its 40 rape crisis centers, only four have
translated materials, and only six have a bi-lingual staff
member.
--The Pennsylvania Coalition Against Rape reports that 25 counties do
not have access to a full-time rape crisis education staff
member. Moreover, in the last year, rape crisis centers have
turned down over 7,000 requests for programs/presentations,
largely due to a lack of staff and volunteers. As a result
between 129,000 and 206,000 persons were not served.
--Of the 10 rape crisis centers in Utah, only one has translated
materials. None have bilingual staff. Only half have 24-hour
hotlines. Three of the programs have no full-time education
staff member. The Utah Coalition Against Sexual Assault reports
they are only reaching 50 percent of the junior high and high
school students in the state through their education efforts.
--In Wisconsin, only three of the state's 38 rape crisis centers have
a full-time community educator. Between one-half and two-thirds
of the centers have only one staff member.
When Congress increased the authorization for the Rape Prevention
and Education Grants as part of VAWA II, it recognized the importance
of this program in reducing sexual victimization. The National Center
calls on Congress to honor its commitment to women by providing full
funding for the Rape Prevention and Education Grant Program for fiscal
year 2002.
For more information, contact Susan Howley, public policy director,
National Center for Victims of Crime, at (703) 276-2880.
______
Prepared Statement of the National Coalition for Heart and Stroke
Research
My name is Jack Owen Wood. I solicit your support for more
aggressive federal funding for research into prevention and treatment
of the sister diseases, stroke and heart disease. Strokes and heart
attacks are occurring at an alarming rate.
I am representing the National Coalition for Heart and Stroke
Research. The coalition consists of 14 organizations representing more
than 5 million volunteers and members united in support for increased
funding for heart and stroke research. Members of the Coalition
include: American Academy of Neurology; American Academy of Physical
Medicine and Rehabilitation; American Association of Neurological
Surgeons; American College of Cardiology; American Heart Association;
Americans for Medical Progress Congress of Neurological Surgeons;
American Neurological Association; Association of Black Cardiologists;
Citizens for Public Action on Blood Pressure and Cholesterol, Inc.;
Mended Hearts, Inc.; North American Society of Pacing and
Electrophysiology; Stroke Connection, Inc.; and the National Stroke
Association.
I will deal primarily with one man's personal experience with
stroke and its functional and financial costs--my own. I have only the
use of my right arm.
I was born in 1937, raised in Vicksburg, Mississippi, earned an
engineering degree at Mississippi State University and currently reside
in Port Orchard, Washington.
I worked for the Boeing Company in Seattle, am a former Director of
the Washington State Energy Office, served as Director of Cost and
Revenue Analysis and as the Forcasting Manager for a major Northwest
Area Natural Gas Utility until May 1, 1995.
On May 1, 1995, at the age of 57, I was stricken and severely
disabled by my stroke. Two years later I experienced a triple bypass
heart operation. You might say I've ``been there and done that'' for
both major cardiovascular diseases. So you see, I am an expert.
Last year I was offered an exciting and rewarding volunteer
opportunity. I was asked to lead the ``JACK WOOD STROKE VICTOR TOUR''
for the American Heart Association.
The JACK WOOD STROKE VICTOR TOUR was a 5-state lobbying tour.
Through it I tried to meet personally with every Northwest
Congressional representative on his or her home turf (in Alaska, Idaho,
Montana, Oregon and Washington). In each meeting I was joined by local
people, stroke survivors and their families and medical professionals.
I told my story and asked them to join the Congressional Heart and
Stroke Coalition and to support increased federal heart and stroke
research funding.
I am proud to say I traveled to 18 communities and meet personally
with 28 members of our delegation or their staff. Nearly half of our
congressional delegation is now members of the Congressional Heart and
Stroke Coalition.
One of the most powerful memories for me was the frequency in which
Members of Congress or staff members related their personal experience
with stroke. One member I spoke to lost both parents to stroke. I
suspect many of you have stories too.
I realize your interest is greater than the physical impact of my
stroke. Your concern must include the financial impact, not only on me,
but on our country from increased health care costs and lost
productivity and its many implications.
I have confronted the difficult and painful task of calculating
that cost to me. Besides being a man whose stroke took his ability to
pick up and play with his grandchildren, his livelihood, and marriage,
I remain a statistician at heart. I couldn't resist calculating and
telling that part of my story. But please remember my story is not
dissimilar to that of many of the 4.5 million stroke survivors in the
United States. Many of whom were stricken in their prime earning years.
Who in a matter of moments, seemingly without warning, are transformed
from a contributor and provider to a receiver and patient.
My full analysis is on the final page of my written testimony.
Allow me to highlight three figures that I feel sum up my data and
should be important to you. I estimate that my stroke at age 57:
--Reduced my earnings before retirement age 65 by over $600,000.
--Subsequently, the cost to the federal government in lost income and
other taxes, early Medicare payments and Social Security
disability payments is over $320,000.
--My HMO spent approximately $150,000 to respond to and treat my
stroke.
--One man, over one million dollars.
About 600,000 Americans will suffer a stroke this year costing this
nation an estimated $45 billion in medical expenses and lost
productivity.
Earlier I described a stroke as occurring seemingly without
warning. All too often as in my case, people either don't know or
ignore the signs of a stroke, even one in progress. When my stroke hit
I denied it. It took me two days after my stroke to acknowledge it and
seek help. Because of research into new treatments, we now have t-PA,
which if administered within 3 hours of the onset of stroke symptoms,
can dramatically reduce the damage of certain kinds of strokes. Had I
recognized and acknowledged my stroke, gone to a hospital with a
neurologist on staff and had there been tPA, the impact of my stroke
most certainly would have been lessened.
What is even more painful to me is that my impending stroke could
have been detected. Unfortunately, we need to create easier and less
expensive diagnostic techniques so that effective diagnostics can be
given routinely as part of regular health exams. And they must be
covered through insurance.
I am not asking for your sympathy. Instead, please think of me as
two of the ghosts in the famous Dickens' story. Please don't
misunderstand, I'm not casting you as Scrooge. See me as both the
ghosts of things past and things yet to be. I too am here to tell you,
the future, which I represent, needs not be. It is largely up to you.
I hope my story and estimate of the cost of my stroke convinces you
that taking on stroke and heart disease through increased research,
leading to better prevention, diagnosis and treatment is fiscally
responsible. The human and financial costs are astronomical.
Thank you for your past support of research and recent decision to
eliminate (at least for now) restrictions on reimbursement for
rehabilitation services, essential to those who have experienced a
stroke. Please continue and broaden that support.
______
Prepared Statement of the National Fuel Funds Network
INTRODUCTION
The National Fuel Funds Network thanks the members of the
Subcommittee for the opportunity to submit this testimony. We thank the
Chairman and other subcommittee members for your efforts in securing
$1.86 billion in sorely needed energy assistance funding for fiscal
year 2000.
The National Fuel Funds Network (NFFN) supports funding for the
Low-Income Home Energy Assistance Program (LIHEAP) in the amount of $2
billion in regular funds plus $300 million in emergency funds, the
maximum amount authorized for fiscal year 2002. NFFN also supports
advance funding in the amount of $2 billion for fiscal year 2003. The
Network also supports the Bingamin amendment to the bankruptcy reform
bill, which authorizes $3.4 billion for LIHEAP.
The NFFN is a membership organization comprised of over 200 dues-
paying representatives of private fuel and energy assistance funds,
community action agencies, social service organizations, utility
companies, local and Tribal governments, trade associations and private
citizens. Our member organizations are located in 44 states and the
District of Columbia.
The NFFN members raise private contributions in their local
communities or states to assist people with low incomes to pay home
energy bills. Fuel funds range from small church organizations that
distribute hundreds of dollars in a single neighborhood to large
independent organizations that distribute millions of dollars across a
state. Fuel funds may be a division of a large social service agency,
or a local utility or energy company may operate them. Some Indian
tribes maintain fuel funds to supplement LIHEAP programs. Since our
first steering committee meeting in 1984, the NFFN and its member
organizations have put into action a commitment to help people of
limited means, due to chronic poverty and temporary misfortune or
illness, meet their basic energy needs.
Whatever their form, all fuel funds raise and distribute private
sector monies, and they all, inevitably, discover that the resources
they manage and the resources provided by LIHEAP are inadequate.
Therefore, fuel funds are becoming increasingly involved in attempting
to locate or direct even more financial resources to help the poor meet
their energy needs.
Nationally, fuel funds assist almost 1.8 million households to make
heating and cooling bill assistance payments of over $102 million this
year. These payments, while vitally needed, are quite small in
comparison to the $1.86 billion in fiscal year 2000 LIHEAP funding.
During the 1990's there was a consistent demand for energy
assistance funding despite the fact it was one of the warmest winter
decades on record. The households assisted during this period were
among the poorest of the poor with average household incomes of less
than $8,000 per year in most states for a family size of 2.6.
A 1999 NFFN survey revealed that many fuel fund managers reported
an increase in their energy assistance caseloads due in part to the
1996 Welfare to Work legislation.
Fuel Funds have worked vigorously to raise private non-federal
funds to assist needy households during the last decade, raising $74
million in 1994, $88 million in 1998 and an estimated $100 million this
winter.
Despite these valiant efforts, the amount of funds raised by fuel
funds is very small compared to federal LIHEAP funds of $1.86 billion
for his winter.
The current 2000/2001 winter has highlighted the need for not only
continued but increased LIHEAP funding.
IMPACT OF RISING ENERGY PRICES
The increases in energy costs this winter, especially natural gas
has greatly increased the energy burden i.e. the ratio of energy costs
to household income borne by poor households. As you know, natural gas
prices this winter have averaged, at times, three to four times the
prices paid last year. In addition, the weather across most of the
country this winter was not only considerably colder than last winter,
but colder than normal, with records set in some areas.
The combination of colder weather and dramatically higher energy
costs have imposed an unbearable energy burden on the poor.
A December 2000 study by Economic Opportunities Studies estimated
the energy burden for poor households this winter would be 19 percent
for households with incomes of 125 percent of poverty and 14 percent
for households at 60 percent of the average of the states' median
incomes compared to 3.2 percent for middle-income households not
eligible for assistance.
The above energy burdens were based on a projected natural gas
price increase of 40 percent above the 1999-2000 winter. Current
estimates indicate natural gas prices will average 60 percent more
above last winter, thus imposing an even greater burden on the poor.
Moreover, by the time the heating season and cut off moratoria
ended, millions of households faced utility cutoffs because of
arrearages amassed during the winter. Indeed, a recent National Energy
Assistance Directors Association study tallies 3.6 million households
in only eighteen states.
FUEL FUNDS RESPONSE TO CRISIS
Fuel Funds, in response to the above escalations in energy costs
and colder weather have aggressively stepped up their fundraising and
service delivery efforts.
For example, the Victorine Q. Adams Fuel fund in Baltimore City
anticipates servicing 50 percent more households this winter compared
to last winter or 3,000 vs. 2,000 respectively.
The Dollar-Help program in St. Louis has increased its fundraising
from about $550,000 two years ago to an estimated $800,000 this winter
and will serve about 2,500 households this winter as compared to 2,000
in 1999.
KeySpan Energy recently announced a $3 million in grants to fuel
funds serving New York City, Long Island and New England. Entergy--New
Orleans donated $1 million to two fuel funds in that city.
NFFN estimates contributions to fuel funds are up at least $12
million this year for a total of $100 million vs. $88 million raised in
1998-99.
Local and state governments have also increased their funding of
energy assistance in their jurisdictions.
In Ohio Governor Taft committed $2.5 million in state funds for
energy assistance and challenged the state's utilities to match the
state's commitment. In response, Columbia Gas of Ohio formed the
Columbia Energy Assistance Fund with $3.5 million, Dominion East Ohio
Gas expanded the People Helping People Fund with a $1 million
contribution and Cinergy expanded its Heatshare program from $100,000
to $500,000.
Some cities have used a portion of their increased Gross Receipts
tax revenues to fund energy assistance efforts through Community Action
Agencies and fuel funds.
In the city of St. Louis, the Board of Aldermen and the Mayor
appropriated $1.13 million for energy assistance. In western Missouri,
several cities either reduced their Gross Receipts taxes or donated a
portion for energy assistance.
The above efforts, while worthy of praise are small when compared
to the LIHEAP funding for this winter of $1.86 billion. Therefore, it
is clear that the most ambitious private efforts cannot replace LIHEAP.
These private efforts, when used in partnership with LIHEAP serve as a
very helpful safety net supplement to the very needy.
Most states have experienced dramatic increases in applications for
assistance this winter as a result of the severe weather and energy
cost increases. Many of the agencies responsible for delivering
assistance are experiencing large backlogs due to a shortage of modern
computers and electronic capability such as e-mail.
Approximately half way through the 2000-2001 heating season in
Colorado, more than 49,585 households have been approved for energy
assistance through the LIHEAP program. This number exceeds the caseload
of 48,417 households served during the entire 6 month heating season in
1999-2000. Applications for assistance set records exceeding the number
of applications ever to have been accepted by the state administered
federally and privately funded LIHEAP program.
Privately funded non-profits, charities and faith-based
organizations have also seen caseloads up by more than 50 percent from
last year serving in excess of an additional 10,000 households not
currently served by LIHEAP.
Call volumes to my agency, Colorado Energy Assistance Foundation
show astronomical increases rising from approximately 25 calls a day in
January and February to recorded levels of 543 calls per day. Averages
are running in the neighborhood of 270 calls per day.
To ease the problem of backlogs and to avoid the non-delivery of
sorely needed help, NFFN recommends the use of a portion of LIHEAP
appropriation for the purchase of new sorely needed delivery equipment.
The summer of 1995, with its oppressive heat and loss of lives
taught us that energy assistance is a year around issue and the need
for LIHEAP funding is almost constant.
As evidenced by this winter, the volatility in energy prices
experienced this winter, as well as cold weather can wreak havoc on the
lives of the poor.
In St. Louis, for example some lenders are offering to refinance
mortgages for people to pay increased heating bills.
CONCLUSION
In conclusion, NFFN strongly supports and urges the approval of a
fiscal year 2002 LIHEAP appropriation of $2.3 billion, $2 billion in
regular funding and $300 million in emergency funds. We also urge the
Subcommittee to provide advance appropriations for fiscal year 2003 at
the same level. State and Tribal agencies need advance funding to
insure stability and continuity. This holds especially true in a time
of volatile home energy prices.
Fuel Funds will continue their efforts to serve as a helpful safety
net supplement to LIHEAP but cannot in any way replace the vital role
LIHEAP plays in the lives of the poorest of our neighbors.
NFFN is grateful for this opportunity to submit testimony the
Subcommittee.
______
Prepared Statement of the National Indian Child Welfare Association
The National Indian Child Welfare Association appreciates the
opportunity to submit testimony regarding fiscal year 2002 funding
child welfare and mental health programs that serve our most precious
resource--our children. Our comments will focus on the need for mental
health services for Indian children and for research and services
related to abuse and neglect of Indian children. Specifically, we need
increased resources and/improved access to the following DHHS programs:
(1) Substance Abuse and Mental Health Services Administration
(SAMHSA) programs:
--Knowledge, Development and Application category--Circles of Care
tribal children's mental health grant program
--Comprehensive Community Mental Health Services for Children and
their Families grant program--funding for tribal children's
mental health service sites.
(2) Administration for Children and Families (ACF) Office of Child
Abuse and Neglect under the Child Abuse Prevention and Treatment Act
(CAPTA) programs:
--National Clearinghouse for Child Abuse and Neglect Information and
--Child Abuse Research and Demonstration.
(3) There are barriers to funding services for Indian children,
especially in the Foster Care and Adoption Assistance programs, the
Mental Health Block Grant, and the Child Abuse Prevention and Treatment
Act state grants.
The National Indian Child Welfare Association (NICWA).--NICWA,
headquartered in Portland, Oregon, provides a broad range of services
to tribes, Indian organizations, and state and federal agencies that
serve Indian children and families throughout the United States. These
services are not direct client services such as counseling or case
management. Rather, they are services that strengthen the programs that
serve Indian children and families. Our services include: (1)
professional training for tribal and urban Indian child welfare and
mental health professionals; (2) technical assistance to improve child
welfare and mental health programs that serve Indian children; and, (3)
activities to promote improved public policy for Indian children and
families. In addition to maintaining a strong network in Indian country
by working closely with the National Congress of American Indians and
tribal governments across the nation, we have established mutually
beneficial partnerships with organizations including the Federation of
Families for Children's Mental Health, the Child Welfare League of
America, and Casey Family Programs.
Program.--Circles of Care tribal grantees under the budget category
of Knowledge, Development and Application (last year for this 3-year
grant program is fiscal year 2001).
Fiscal year 2001 Enacted.--$2.4 million (approximately $0.7 million
was reserved for the Circles of Care grant program).
DHHS Division.--Substance Abuse and Mental Health Services
Administration.
Recommendation.--$3 million, with $1.1 million for the Circles of
Care projects
Justification.--The Circles of Care projects utilize the most
current and innovate thinking in delivering Indian children's mental
health services. The current nine Indian community grantees, which base
their efforts in ``a system of care'' model, are engaging local
communities in partnerships and capacity building for children's mental
health services. Within the field of children's mental health, a system
of care is a formal collaboration of the family and community members,
professional and other organizations committed to enhancing the lives
of emotionally disturbed children and their families.
All of the Circle of Care Indian projects are subject to rigorous
external evaluation which helps determine the feasibility of project
designs and also the potential for successful replication in other
communities.
Historically, American Indians/Alaska Natives have had little
access to mental health services, and funding from Indian Health
Service for this purpose has been minimal. Funding planning efforts is
critical to the successful building of systems of care for American
Indian/Alaska Native children with severe emotional disturbances. We
ask Congress to provide additional planning grants so that other tribes
and urban Indian organizations can enter into partnerships with Indian
and non-Indian agencies to develop community-based mental health
programs.
The Circles of Care programs are demonstrating that careful
planning combined with community partnerships can make a positive
difference in helping children with severe emotional disturbances and
their families.
Program.--Comprehensive Community Mental Health Services for
Children and their Families grant program (tribal service site
funding).
Fiscal year 2001 Enacted.--Approximately $91.7 million.
DHHS Division.--Substance Abuse and Mental Health Services
Administration.
Recommendation.--Recommend (1) reserve 10 percent of the total
allocation to this program for tribal applicants and (2) exempt Indian
tribes and organizations from population limits used to allocate these
grant funds.
Justification.--Developing systems of care for Indian children
with, or at risk of, emotional and behavioral disorders has been
initiated through the Children's Mental Health Services tribal service
grantees. To date, seven tribal sites have received grant awards.
Information and descriptions of the most ``promising practices'' of the
full range of the mental health services are being documented in the
Promising Practices monograph series. The monograph devoted to the
Native American grantees was released in June 2000. This monograph
poignantly illustrates the success of community-based systems of care
when American Indian communities are afforded the advantages of
designing systems tailored to their specific needs.
Focusing on cultural and family strengths, parent and community
involvement, and ongoing service evaluation, the service sites yield
rich information useful to Indian and non-Indian providers. Substantive
data gathering is an integral part of tracking the success and
challenges of implementing new systems of care in Indian country. The
verbal reports of parents and children enrolled in some of the
project's systems of care suggest a high rate of success and
demonstrate high consumer satisfaction by parents and children. A 10
percent allocation would enable funding of additional sites that are in
desperate need for children-specific mental health services.
The formula for funding grantees only allows a specified number
people to be served within a given state. If a state becomes a grantee
it would almost automatically exclude any American Indian/Alaska Native
tribes from being awarded a grant in that same state even though they
would be serving different populations and using a different service
delivery system. Many states have numerous tribes in rural areas with
small populations. We believe that the program should fund tribes in a
way that honors the government-to-government relationships. An
allocation of dollars to these Native populations that is unrestricted
by state populations addresses the inordinately high index of need for
mental health services of American Indian/Alaska Native children.
Program.--National Clearinghouse for Child Abuse and Neglect
Information, Child Abuse Research and Demonstration.
Fiscal year 2001 Enacted.--$33 million (no portion of these funds
are reserved for a Tribal grant program, but Tribes receive services
from the clearinghouse as well as a few discretionary grants).
DHHS Division.--Office of Child Abuse and Neglect.
Recommendation.--Recommend an allocation of at least $2 million to
support research, information services and demonstration projects in
American Indian communities.
Justification.--Beginning with the passage of the Indian Child
Welfare Act in 1978, tribes began in earnest to reclaim their
responsibility for the protection of tribal children (Canby, 1998).
Today almost every tribe in the nation provides some form of child
welfare services to their children, and approximately two-thirds are
directly involved in the investigation of cases of child abuse and/or
neglect (Earle, 2000). Efforts to address the problems of abuse/neglect
of Indian children living on tribal lands are hampered by the fact that
no one knows how widespread the abuse/neglect of Native children really
is. Although there are various sources of data for the rates of abuse/
neglect of Indian children, the accuracy of these data is suspect not
only due to problems of definition and limited scope but to the
inability to collect accurate data on the known cases of child abuse/
neglect.
U.S. Bureau of Justice statistics for 1995 reported a per capita
rate of one substantiated report of a child victim of abuse or neglect
for every 30 American Indian children aged 14 or younger. This compares
to one report for every 58 children of any race, approximately half the
rate for Native children. It was the highest rate of abuse or neglect
reported for any ethnic group. In addition, American Indians and Asians
were the only racial/ethnic groups to experience increases in the rate
of abuse or neglect of children under age 15 from 1992 to 1995 (Dept.
of Justice, 1999). Data from the National Child Abuse and Neglect Data
System (NCANDS) show that, for child maltreatment victimization rates
by race and ethnicity in 1998 (40 states reporting), the rate for
Native children was 19.8 cases per 1000 children. This compares to a
rate of 3.8 for Asians/Pacific Islanders, 8.5 for Whites, and 10.6 for
Hispanics (U.S. Dept. of Health and Human Services, Children's Bureau,
2000). Tribes and policy makers desperately need research on the extent
of the problem and information about how to combat child about in their
communities.
STATUTORY AND REGULATORY BARRIERS TO FUNDING SERVICES FOR INDIAN
CHILDREN
While we recognize this Committee does not have the authority to
amend language in the authorizing statutes, we feel it is important
that the Committee be aware of the disparity in access to federal
funding that exists for Indian children. Therefore, we are providing
information on key programs that have the potential to fund services
for Indian children under tribal jurisdiction, but contain significant
barriers. The appropriations for these programs, however, do fall under
the purview of this Subcommittee.
Program.--Foster Care and Adoption Assistance (Title IV-E of the
Social Security Act).
Fiscal year 2001 ENACTED.--Entitlement funding $5 billion (foster
care) and $1.2 billion (adoption assistance).
DHHS Division.--Children's Bureau under the ACF.
Recommendation.--Support legislation (to be introduced in the
Senate in March) to include tribal governments as eligible for direct
reimbursement for Title IV-E services they provide to eligible Indian
children under their jurisdiction and care. We point out that the
American Public Human Services Association, the organization of state
social service agencies, has recently formally endorsed the provision
of direct funding to tribes under the IV-E statute.
Justification.--While Congress intended for the Title IV-E program
to serve all eligible children in the United States, Indian children
under the jurisdiction of a tribal government and living on tribal
lands do not have an entitlement to this important program afforded
other children. The statute provides services only for income-eligible
children placed by states and public agencies with which states have
agreements. While approximately 70 tribes have been able to forge
agreements with a state to access Title IV-E funds, the vast majority
of tribes have no access. In those states where agreements exist,
tribes often receive only a portion of the funding available overall to
support foster care and adoption related services. With no stable
source of foster care and adoption assistance funding, tribes have
struggled to provide the same level of protection and permanency that
other children are guaranteed under this federal program. By enacting
the soon to be introduced legislation in the Senate that would add
tribes to Title IV-E, the federal government can provide a higher level
of security and permanence for Indian children than would be found in
any other federal funding source.
Program.--Mental Health Performance Partnership Block Grant.
Fiscal year 2001 Enacted.--$420 million.
DHHS Division.--Substance Abuse and Mental Health Services
Administration
Recommendation.--We recommend the authorizing statute be amended to
provide tribal governments direct access to the Mental Health Block
Grant. We recommend that 3 percent of the overall appropriation be
reserved for direct allocation to tribal governments. To fund this
recommendation without impacting state allocations, we also recommend
increasing the overall level of appropriation by 3 percent. The
specific allocation for individual tribes could be based on a formula
that would be similar to the one used for the allocation of tribal
funds from the Child Care and Developmental Block Grant. This formula
provides a base amount of funding for every tribe, in addition to a per
capita amount based on the tribe's population.
Justification.--Tribal governments do not have access to the Mental
Health Performance Partnerships Block Grant and therefore miss out on
funding opportunities to support mental health services for both Indian
adults and children. These monies are distributed by formula to state
and territorial governments, but not to tribal governments.
Additionally, tribes and tribal organizations are eligible applicants
for only some of the discretionary mental health grants under the
Substance Abuse and Mental Health Administration. Mental health block
grants not only can address immediate mental health needs, but also
support long-term capacity building for tribes and the communities they
represent.
Program.--Promoting Safe and Stable Families Act (Title IV-B ,
Subpart 2 of the Social Security Act).
Fiscal year 2001 Enacted.--$305 million capped entitlement.
DHHS Division.--Children's Bureau under ACF.
Recommendation.--Amend the authorizing legislation to increase the
amount of reserved funds for tribal governments from 1 percent to 3
percent of the overall appropriation. Current levels of funding and the
statutory language only allow 66 tribal grantees to be eligible to
receive funding under this program.
Justification.--This program is part of an overall federal system
of child welfare funding designed to support a more comprehensive array
of program services in child welfare. Title IV-B, Subpart 2 helps
promote services to prevent the removal of children from their homes,
reunify them with their families after removal when possible and
provide services to support adoption when return to the home is not
possible. As an indicator of need, Indian children in the United States
are placed in substitute care at a much higher rate than is the average
for all other children in the nation. 12.5 out of every 1,000 Indian
children are placed in substitute care, compared to 6.9 out of every
1,000 children from all races (Child Welfare League of America, 1996,
with 34 states reporting substitute care data). This funding has been a
good fit for tribes who have been eligible to receive grants. However,
with only a small portion of the total number of federally recognized
tribes eligible, the program has had little impact on the overall need
for these services in tribal communities across the United States. One
of the primary purposes of the program was to stimulate systems change,
a goal that is definitely needed in child welfare, but again, the small
amount of funding and restricted eligibility has made it very difficult
to create and sustain any meaningful change for tribal governments.
Program.--State grants under the Child Abuse Prevention and
Treatment Act (CAPTA).
Fiscal year 2001 Enacted.--$21 million.
DHHS Division.--Office of Child Abuse and Neglect.
Recommendation.--We recommend that the authorizing statute be
amended to provide tribal governments direct grants for child abuse
prevention and treatment programs. Tribes receive no funding under the
state grants.
Justification.--Given sharply increasing reports of maltreatment,
(Greenfeld and Smith, 1999) prevention programming must be expanded in
American Indian communities. While Indian people have a heritage for
child protection, we also have a growing problem with child abuse and
neglect. If we are to survive as nations, we must turn this around. It
is essential that Tribes build the capacity to conduct comprehensive
child abuse and neglect prevention and treatment programs. National
attention on this topic is needed. It is our belief that direct tribal
grants under CAPTA will be helpful in shaping future of our children.
______
Prepared Statement of the National Latex Allergy Network
On behalf of the National Latex Allergy Network (formerly ELASTIC
Inc.), a nonprofit voluntary health organization, and the 2.3 million
Americans estimated to be sensitized to natural rubber latex. I would
like to thank Senator Specter, Ranking Member Senator Harkin, and
Members of the Subcommittee for the opportunity to provide written
testimony.
We are respectfully requesting that the Senate subcommittee
allocate federal funds to facilitate and advance research in the area
of latex allergy. Scientists from all over the country are working very
hard to help the growing number of people who are becoming sensitized
to latex. There is a critical need for financial support in all areas
of research, including pathophysiology, existing and unknown causative
factors, occupational asthma, diagnostics, immunotherapy, product and
environmental safety standards, treatment standards and prevention
strategies.
Increased use of latex, most notably, latex gloves, to prevent
infectious diseases has been followed by an increase in the number of
people affected by latex allergy. In 1991, the FDA issued a medical
alert in response to growing reports of allergic reactions by patients
to latex-containing medical devices. At this same time the CDC was
investigating clusters of anaphylactic reactions among young patients
undergoing treatment at various children's hospitals across the
country.
The explosion of anaphylaxis and serious allergic reactions to
latex gloves and other medical equipment shocked physicians,
researchers and regulatory government agencies because, quite simply,
prior to the mid-1980's, latex allergy was virtually unheard of.
Latex, or more accurately, natural rubber latex, is harvested from
the Brazilian rubber tree found in Africa and Southeast Asia. The
culprits are certain allergenic proteins retained in varying amounts in
finished products such as gloves, medical equipment, balloons, condoms
and toys. With the exception of medical gloves and other medical
devices, there are no regulations for content labeling or warnings.
How a product is made determines the amount of latex allergens
retained in the finished item. Currently, there are no federal
regulations that limit the amount of allergenic proteins in finished
products. The FDA Center for Medical Devices and Radiological Health is
in the process of finalizing recommendations for maximum levels of
extractable protein and powder per glove for medical exam and surgeon's
gloves. This has been a lengthy effort and applies only to the medical
gloves regulated by this agency.
A joint statement of the American Academy of Allergy, Asthma &
Immunology and the American College of Allergy, Asthma & Immunology
published in 1997 defines latex allergy as an IgE-mediated latex
allergy that results from cumulative exposure of susceptible
individuals to natural latex rubber proteins (allergens) and identify
medical gloves and equipment as the largest single source of exposure
to these potent allergens. Exposure to bio-available latex allergens is
by direct contact with an offending device or by inhalation of
allergens carried by cornstarch powder with which most powdered gloves
are coated. The clinical manifestations of latex allergy range from
mild contact urticaria to fatal anaphylaxis.
Latex allergy, an IgE-mediated reaction to proteins retained in
finished natural rubber latex products, has emerged in the 1990s as one
of the most pervasive problems in medicine, affecting both patients and
health care providers. ``Latex allergy has resulted in death,
progressive asthma, severe food allergy from cross-reactivity, and
disability of health care professionals with the accompanied loss of
self-esteem and income as a result of their inability to work in their
chosen profession.'' (Kelly KJ, Walsh-Kelly CM--Latex allergy: A
patient and health care system emergency. J Emerg Nursing Dec 1998
24;6:539-545)
While similar to peanut, stinging insects and drug allergies in the
risk for life-threatening anaphylaxis, latex allergy is unique in that
the latex gloves and other medical products used in emergency
situations to save a life could cause a fatal anaphylactic reaction.
Since the early 1990s, the FDA has received over 2,000 adverse
event reports describing allergic reactions to medical gloves
containing natural rubber latex. These reports relate both to patients
and users of natural rubber latex products. These reports include 16
deaths, 5 caused by latex gloves.
While working as a general dentist, I had never heard of latex
allergy, let alone had any inkling of the enormous burden it would
impose on my family, the dilemma it would pose for my health care
providers and the debilitating effect it would have on my health. That
is, not before the summer of 1994 when I was diagnosed with latex
allergy and asthma caused by the latex gloves I wore everyday and the
``second-hand latex'' from the latex-laden powdered gloves everyone in
the office used.
Nor did I think that something so innocuous that I would lose my
practice and become so chronically ill those even day-to-day activities
would be nearly if not totally impossible. Who would have thought the
very products we used everyday as health care providers would end my
career in dentistry and impose an enormous physical, emotional and
financial burden on my family?
Latex glove use has spilled over to non-medical settings, so much
so that a Philadelphia nurse and latex allergy prevention advocate has
developed a new spin on an old nursery rhyme. ``Butcher, baker,
beautician, thief, mechanic, chef, fire chief . . . the common
denominator here is routine latex glove use! The list of occupations
also wearing gloves for barrier protection includes; farmers, produce
pickers, factory workers, restaurant and food service workers, day care
workers, dog groomers, landscapers, painters, toll collectors, auto
factory workers as well as florists, housekeeping and janitorial
service workers, students for science, art and shop classes.
Latex allergy develops primarily because of repeat exposure to
significant levels of allergenic proteins retained in finished products
made from natural rubber latex (NRL), in particular latex gloves and
other medical equipment that contact mucosal tissues.
The transfer of allergenic latex proteins from glove surfaces to
food products has been scientifically documented resulting in an often
hidden source of latex exposure for consumers. Disposable latex gloves,
commonly utilized by food handlers, are a source of indirect food
additives violating Section 402(a)(1) of the FDA Food Regulations which
state: ``A food is illegal (adulterated) if it bears or contains an
added poisonous or deleterious (harmful) substance which may render it
injurious to health.''
Health risks to consumers and workers associated with latex glove
use in all aspects of food service--from farm to table. As stated in
the 1999 Food Code Annex 3 3-3-4.15; 3-304.15--Gloves, Use Limitation--
``Natural rubber latex gloves have been reported to cause allergic
reactions in some individuals who wear latex gloves during food
preparation, and even in individuals eating food prepared by food
employees wearing latex gloves (refer to Annex 2 for this section).''
The FDA is currently evaluating safety issues associated with latex
glove use in the food industry.
Avoidance of latex allergens is presently the only method to
prevent reactions, latex-related asthma and latex sensitization.
Commonplace use of medical and non-medical latex gloves as well as
hundreds of other products encountered in daily life makes this task
extremely difficult. Ironically, the prevalence of latex in gloves and
other life-saving equipment used by first responders, emergency medical
service providers, emergency rooms and hospitals, has resulted in a
critical public health crisis--access to safe emergency and routine
health care for the growing number of latex allergic patients.
Mr. Chairman, I thank you again for the opportunity to provide the
Committee with information about this newly emerged disease, latex
allergy. Government agencies are working hard to provide product and
environmental standards and guidelines. Federal funding for medical
research would provide the thousands of families affected by latex
allergy a source of hope for universal access to safe health care, safe
school and work environments and especially hope for a cure. Please
help us advance and expedite treatment and a cure for latex allergy by
providing funding for research.
______
Prepared Statement of the National Down Syndrome Society
Chairman Stevens, Members of the Committee: The National Down
Syndrome Society is pleased to submit written testimony in support of
improved health care for individuals with mental retardation, including
people with Down syndrome.
NATIONAL DOWN SYNDROME SOCIETY (NDSS)
The National Down Syndrome Society represents more than 350,000
individuals with Down syndrome who live in the United States, their
families, friends and professionals who serve them. The National Down
Syndrome Society was established in 1979 to ensure that all people with
Down syndrome have the opportunity to achieve their full potential in
community life. Since that time, NDSS has become the largest non-
governmental supporter of Down syndrome research in the United States.
Today, NDSS continues to increase public awareness about Down syndrome
and discover its underlying causes through research.
Under the leadership of a Board of Directors, Scientific Advisory
Board, Clinical Advisory Board, Affiliate Advisory Board and Self-
Advocate Advisory Board, NDSS distributes timely and informative
materials, supports activities of local parent support groups, sponsors
conferences and scientific symposia and undertakes major advocacy
efforts--all to help improve lives of people with Down syndrome.
More than 125 parent support groups and related member
organizations comprise the NDSS Affiliate Program. The NDSS affiliate
members form the grassroots structure of the organization and represent
thousands of individuals with Down syndrome and their families from
around the country.
DOWN SYNDROME
Down syndrome is the most commonly occurring chromosomal
abnormality, occurring in approximately one in every 800 to 1,000 live
births. There are approximately 6,000 people born with Down syndrome in
the United States each year and thousands more impacted by this genetic
condition. Most people with Down syndrome have some degree of mental
retardation, usually in the mild to moderate range.
Children with Down syndrome are at increased risk for certain
health problems. Congenital heart defects (50 percent), endocrine
problems (10 percent), neurological conditions (10-20 percent),
increased susceptibility to infection, respiratory problems, obstructed
digestive tracts and childhood leukemia occur with greater frequency
among children who have Down syndrome. Adults with Down syndrome are at
a significantly increased risk for Alzheimer's disease (25 percent),
dental problems, thyroid concerns, musculoskeletal problems and
depression. These, of course, do not include the many other kinds of
health care problems that everyone in the population is susceptible to.
Today, the average life expectancy of individuals with Down
syndrome is approximately 55 years, with many living even longer. As
this population ages, the need for access to adequate health care and
for well-trained professionals to address these needs, becomes even
more critical.
HEALTH CARE PROBLEMS FOR PEOPLE WITH DOWN SYNDROME
While advances in medicine have rendered most of these health
problems treatable, some people with Down syndrome do not have access
to necessary care. NDSS has identified the following major health care
issues, based on speaking to many of our constituents:
--Physicians and health care professionals not adequately trained to
meet the medical and health care needs specific to individuals
with Down syndrome.
--Access to health care and surgical procedures being denied to
individuals with Down syndrome based on discrimination and
attitudes, rather than medical necessity.
--People being denied health insurance on the basis of Down syndrome
being considered a ``preexisting condition.''
These problems with the current systems as they relate to
individuals with Down syndrome represent just some of the issues we
hear.
THE CHALLENGE
Throughout the years, NDSS has heard hundreds of stories from
parents about insensitive attitudes on the part of health care
professionals, whether in presenting a diagnosis of Down syndrome or in
treatment, as well as professionals being inadequately prepared with
the necessary information and resources to work with their child. NDSS
has also been contacted by numerous physicians, nurses, social workers,
genetic counselors and others seeking information and resources that
will help them to better care for their patients who have Down
syndrome. There is very limited training available for health care
professionals on how to address the specific needs of people with Down
syndrome.
There are many resources available, such as the Down Syndrome
Health Care Guidelines, which are critical in helping to ensure that
adequate attention is paid to particular health care concerns. The
challenge has been getting these resources into the hands of those who
need it the most. NDSS works closely with the Down Syndrome Medical
Interest Group, comprised of more than 150 physicians and clinicians
worldwide who have an interest in working with this population, to
share information and develop resources that will improve the quality
of life for individuals with Down syndrome.
Attached is a summary of Down Syndrome Health Care Guidelines,
based on Health Care Guidelines for Individuals with Down Syndrome:
1999 Revision (Down Syndrome Preventive Medical Check List), published
in Down Syndrome Quarterly (Volume 4, Number 3, September, 1999, pp. 1-
16).
CONCLUSION
The opportunities today for individuals with Down syndrome and
mental retardation have never been greater, thanks to the commitment
and dedication of many legislators, organizations, families and
agencies. In the past 25 years alone, groundbreaking legislation has
lead to de-institutionalization, inclusion in schools and a no-
tolerance attitude towards discrimination against people with
disabilities. Now that the laws are in place and the opportunities to
succeed available, we owe it to people with mental retardation to
ensure they are healthy enough to take advantage of all that is
available.
We appreciate your taking the time to read our testimony, and
applaud you for your interest in helping to improve health care for
people with mental retardation. Please do not hesitate to contact us if
we may be of any assistance to you in your efforts.
Attachment I--Addressing the Health Care Needs of People With Down
Syndrome
The National Down Syndrome has been dedicated to improving health
care for individuals with Down syndrome since its inception in 1979.
Under the direction of a Science Advisory Board and Clinical Advisory
Board comprised of distinguished, world-renowned experts on Down
syndrome-related issues, NDSS has developed programs and resources to
address these needs.
Science Scholar Award Program.--Each year NDSS awards research
grants to promising postdoctoral scientists who have demonstrated
extraordinary skill and achievement in seeking a better understanding
of Down syndrome. Since 1983, more than twenty researchers have
received this prestigious salary grant.
Research Partnership.--NDSS, the National Institute of Child Health
and Human Development and the National Institute of Neurological
Disorders and Stroke are engaged in a $3.9 million partnership to
further Down syndrome research. The funding goes to organizations and
individual researchers studying Down syndrome-specific cognition,
behavior and related therapies. The $3.9 million partnership represents
the most funding ever earmarked for Down syndrome research.
International Down Syndrome Research Conference.--In an effort to
increase communication among the world's most distinguished scientists
working in fields related to Down syndrome, NDSS hosts international
scientific conferences on relevant research topics. The proceedings of
these conferences are published and distributed worldwide.
Educational Services.--The NDSS Information and Referral Center
responds to over 25,000 requests annually via E-mail and toll-free
hotline. A large percentage of these requests are related to health
care issues. NDSS has developed and disseminated a Clinical Care
Booklet series to educate parents and professionals about some of the
most commonly occurring health care problems, including the Heart, the
Endocrine System, Neurology, Alternative Therapies, Speech and
Language, and others.
Changing Lives: Down Syndrome & the Health Care Professional
Program.--This new program, still in the pilot phase, is being
developed to support health care professionals in the delivery of
appropriate care and to help children with Down syndrome get the
healthy start they deserve. The program aims to educate health care
professionals in the community about Down syndrome and how best to
treat and diagnose these patients; educate health care professionals on
the medical and developmental needs a baby with Down syndrome may have
and the best care practices to address these needs; provide health care
professionals with materials and resources to share with new and
expectant parents of children with Down syndrome; and raise the
awareness of health care professionals of how attitudes and beliefs
affect the experience of raising a child with Down syndrome.
Attachment II--NDSS Science Advisory Board and Clinical Advisory Board
SCIENCE ADVISORY BOARD
David Patterson, Ph.D., Chair, Eleanor Roosevelt Cancer Research
Institute, CO; Terry J. Hassold, Ph.D., Department of Genetics, Case
Western Reserve University, OH; Julie R. Korenberg, Ph.D., M.D.,
Department of Pediatrics, Cedars-Sinai Medical Center, CA; Ira T. Lott,
M.D., Department of Pediatrics, Irvine Medical Center, CA; and Lynn
Nadel, Ph.D., Department of Psychology, University of Arizona, AZ.
CLINICAL ADVISORY BOARD
William I. Cohen, M.D., Chair, Down Syndrome Center of Western PA,
Children's Hospital of Pittsburgh, PA; Joan E. Guthrie Medlen, R.D.,
Disability Solutions, OR; Jon F. Miller, Ph.D., Waisman Mental
Retardation Center, University of Wisconsin-Madison, WI; Bonnie
Patterson, M.D., Cincinnati Center for Developmental Disorders,
University of Cincinnati, OH; Richard A. Villa, Ed.D., Bayridge
Consortium, Inc., CA; Leslie Walker-Hirsch, M.Ed., Moonstone Group, NY;
and Patricia C. Winders, PT, Down Syndrome Clinic, Kennedy Krieger
Institute, MD.
Attachment III--Summary of Down Syndrome Health Care Guidelines
(Based on Health Care Guidelines for Individuals with Down
Syndrome: 1999 Revision, Down Syndrome Preventive Medical Check List,
published in Down Syndrome Quarterly, Volume 4, Number 3, September,
1999, pp. 1-16)
DOWN SYNDROME--NEONATAL (BIRTH-1 MONTH)
Review parental concerns. Chromosomal karyotype; genetic
counseling, if necessary.
If vomiting or absence of stools, check for gastrointestinal tract
blockage (duodenal web or atresia, or Hirschsprung disease).
Evaluation by a pediatric cardiologist including echocardiogram.
Subacute bacterial endocarditis prophylaxis--SBE, in susceptible
children with cardiac disease.
Exam for plethora, thrombocytopenia.
Review feeding history to ensure adequate caloric intake.
Thyroid function test--check on results of state-mandated screening
at birth.
Auditory brainstem response (ABR) or otoacoustic emission (OAE)
test to assess congenital sensorineural hearing (at birth or 3 months).
Pediatric ophthalmological evaluation (by 6 months) for screening
purposes.
Discuss Early Intervention (infant stimulation) and refer for
enrollment in local program.
Refer to local DS parent group for family support and resources, as
indicated. Refer to NDSS.
DOWN SYNDROME--INFANT (1-12 MONTHS)
General neurological, neuromotor, and musculoskeletal examination.
TSH and T4--Thyroid Function Test (at 6 & 12 months).
Evaluation by a pediatric cardiologist including echocardiogram, if
not done at birth.
Consider progressive pulmonary hypertension in patients with a VSD
or atrioventricular septal defect who are having little or no symptoms
of heart failure.
Subacute bacterial endocarditis prophylaxis--SBE (as indicated).
Well Child Care--immunizations.
Feeding consult, especially if constipated. Consider Hirschsprung
disease.
Auditory brainstem response (ABR) or otoacoustic emission (OAE)
test to assess congenital sensorineural hearing (by 3 months if not
performed previously or if results are suspicious).
Ear, nose and throat exam (as needed), especially if suspicious of
otitis media.
Vision exam (by 6 months & annually), earlier if nystagmus,
strabismus or poor vision.
Discuss early intervention and refer for enrollment in local
program (if not done yet).
Application for SSI, depending on family income; consider estate
planning/custody arrangements; continue family support.
DOWN SYNDROME--CHILDHOOD (1-12 YEARS)
TSH and T4--Thyroid Function Test (annually).
Echocardiogram by a pediatric cardiologist if not done previously.
Behavioral Auditory Testing (every 6 months until age 3, annually
thereafter).
Lateral cervical spine x-rays (neutral view, flexion, extension) to
rule out atlanto-axial instability. Radiologist to measure atlanto-dens
distance and neural canal width (at 3-5 years, then as needed).
General pediatric and neurological exam including evaluation for
signs of spinal cord compression: deep tendon reflexes, gait, Babinski
sign.
Use Down syndrome growth charts and head circumference charts, as
well as growth charts for typically developing children.
Eye examination (annually, or more often as indicated).
Screen for celiac disease IgA antiendomysium antibodies and total
IgA (between 2-3 years).
Question about obstructive sleep apnea; ear, nose and throat exam
(ENT) (as needed).
Dental Exam (2 years; follow up exams every 6 months after). Twice
daily teeth brushing.
Reinforce need for subacute bacterial endocarditis prophylaxis
(SBE) for cardiac problems (as indicated).
Brief vulvar exam for girls.
Well Child Care--immunizations; administer pneumococcal vaccine (2
years).
Well balanced, high fiber diet. Regular exercise program.
Evaluation by a speech and language pathologist to maximize
language development and verbal communication.
Review parental concerns; current level of functioning; monitor for
behavior problems.
Complete educational assessment annually, as part of Individualized
Family Service Plan (IFSP) for child from birth to 3 years of age, or
Individualized Educational Plan (IEP) from age 4 until the end of
formal schooling.
Continue speech therapy and physical therapy (as needed).
DOWN SYNDROME--ADOLESCENCE (12-18 YEARS)
TSH and T4--Thyroid Function Test (annually).
Auditory Testing (annually).
Cervical spine x-ray, if required by Special Olympics.
Monitor for obstructive airway disease and sleep apnea.
General physical and neurological examination (check for atlanto-
axial dislocation).
Eye examination (annually).
Dental Exams (every 6 months). Twice daily teeth brushing.
Monitor for obesity by plotting height for weight on the growth
charts for typical children.
Clinical evaluation of the heart to rule out mitral/aortic valve
problems. Echocardiogram (ECHO) as indicated by clinical findings.
Reinforce the need for subacute bacterial endocarditis prophylaxis
(SBE) in susceptible adolescents.
Adolescent medicine consult for puberty/sexuality issues; health,
abuse prevention and sexuality education. Pelvic exam (only if sexually
active).
Low calorie, high fiber diet; regular exercise program.
Smoking, drug and alcohol education.
Psychoeducational evaluations (every two years), for Individualized
Educational Plan (IEP).
Begin functional transition planning (age 16 years).
Consider enrollment for SSI depending on family income; monitor
independent functioning.
Update estate planning and custody arrangements; discuss plans for
alternative long-term living arrangements such as community living
arrangements.
DOWN SYNDROME--ADULTHOOD (OVER 18 YEARS)
TSH and T4--Thyroid Function Test (annually).
Auditory testing (every 2 years).
Cervical spine x-rays as needed for Special Olympics participation
(or as indicated).
Opthalmologic examination, looking especially for keratoconus and
cataracts (every 2 years).
Dental Exam (every 6 months). Twice daily teeth brushing.
Clinical evaluation of the heart to rule out mitral/aortic valve
problems. Echocardiogram (ECHO) as indicated by clinical exam.
Reinforce need for subacute bacterial endocarditis prophylaxis
(SBE) in susceptible adults with cardiac disease.
Baseline Mammography at 40 years. Follow up every other year until
50 years, then annually.
Pap smear and pelvic exam (every 1-3 years following the age of
first intercourse). If not sexually active, single-finger bimanual
examination with finger-directed cytology exam. If unable to perform,
screen pelvic ultrasound (every 2-3 years). Breast exam (annually).
General physical/neurological exam (atlanto-axial dislocation);
routine adult health care.
Clinical evaluation for sleep apnea.
Low calorie, high fiber diet. Regular exercise. Monitor for
obesity.
Health, abuse prevention & sexuality education.
Smoking, drug and alcohol education.
Clinical evaluation of functional abilities (consider accelerated
aging); monitor loss of independent living skills.
Neurological referral for early symptoms of dementia (decline in
function, memory loss, ataxia, seizures and incontinence of urine and/
or stool).
Monitor for behavioral/emotional changes, mental health. Psych
Referral (as needed).
Continue speech and language therapy, as indicated.
Discuss plans for programming/vocational opportunities at age 21 or
end of formal schooling.
Discuss alternative long-term living arrangements; estate planning/
custody arrangements.
______
Prepared Statement of the National Marfan Foundation
Chairman Specter and members of the Committee, the members of the
National Marfan Foundation (NMF) thank you for the opportunity to
provide written testimony in support of the budget of the National
Institutes of Health (NIH) and the National Institute of Arthritis,
Musculosketetal and Skin Diseases (NIAMS). This is the first year that
the NMF is submitting written testimony on its own. We have been
previously included in the written and spoken testimony of the
Coalition for Heritable Disorders of Connective Tissue (CHDCT). We
would first like to express our gratitude of the Committee's ongoing
support of NIH research, and most particularly their support for
increased funding for research on rare and genetic disorders--research
that might not otherwise have been funded.
The NMF believes that we must sustain the current level of
commitment to the NIH. The NMF joins the Ad Hoc Group for Medical
Research Funding, the Coalition of Heritable Disorders of Connective
Tissue, the NIAMS Coalition, and the Coalition of Patient Advocates for
Skin Disease Research in asking that Congress support a 16.5 percent
increase in the budget of the NIH for fiscal year 2002. This increase
would allow us to get back on track the bipartisan effort to double the
NIH budget by fiscal year 2003--a sentiment shared by the President,
the Congress and the American people.
The Marfan syndrome is a potentially fatal, relatively rare genetic
disorder of the connective tissue. The NMF requests the establishment
and support of Scientific Research Centers for Marfan Syndrome and
Related Disorders which will allow these centers to gather significant
numbers of Marfan affected people to investigate clinical therapies,
which in the case of a rare and multi-system disorder, are the only way
to compile enough individuals to establish well-controlled clinical
studies. This can bring about a comprehensive understanding of the
clinical burden of this syndrome and help to predict manifestations of
the disease before they occur. In addition, the recruitment of
geneticists, molecular and cell biologists who can contribute their
expertise to a common problem, serve to coordinate basic research and
enable these studies to be translated rapidly into advances in patient
care. The goal of establishing Scientific Research Centers for the
Marfan Syndrome and Related Disorders can only be accomplished through
the available mechanisms of the National Institutes of Health.
The NMF represents people affected with the Marfan syndrome.
Voluntary health organizations such as ours consistently hear the
frustrations, confusion and despair of people who deal with the daily
medical issues associated with genetic disorders. In multi-systemic
disorders such as Marfan syndrome, numerous physicians in specialties
such as cardiology and cardiovascular surgery, orthopedics,
ophthalmology, respiratory/pulmonary, neurology, and genetics must be
consulted to manage the manifestations of this syndrome. The families
are distraught from the overwhelming emotional turmoil of dealing with
so many doctors and the fear of losing 2 their life at an early age,
not to mention the tremendous monetary burden. These circumstances are
multiplied many times over since this genetic disorder can affect more
than one family member and more than one generation.
It is estimated that a quarter of a million people in the United
States are affected by the Marfan syndrome and relate disorders. The
Marfan syndrome is a potentially fatal, genetic disorder of the
connective tissue. The Marfan syndrome is a multi-system disorder
because the connective tissue is essentially the glue and the
scaffolding of the body, and manifests itself in the heart, eyes,
skeleton and blood vessels. Individuals with the Marfan syndrome are
uncharacteristically tall, with arms, legs, toes and fingers that are
disproportionately long and thin. Typically, patients also have poorly
developed muscles and abnormally curved spines.
The life-threatening aspect of this disorder is the weakening of
the aorta, the largest artery that supplies blood to the heart. In the
Marfan syndrome, the abnormalities in the connective tissue place a
great deal of stress on the aortic artery and significantly weaken the
walls of this most important blood vessel. Tears form in the walls of
the aorta and death can only be prevented by surgical intervention.
There is no simple diagnosis for the Marfan syndrome. Many patients who
present in emergency rooms fail to receive life-saving treatments. For
example Jonathon Larson, the Tony awardwinning playwright of the hit
Broadway musical ``Rent'', died at the age of 35 after being
misdiagnosed by two different hospital emergency rooms. In addition,
communities across this country often are faced with the premature
death of a future basketball star or athlete, because parents, coaches,
and physicians failed to realize that their height, a tremendous asset
on the basketball court or other athletic arena was in reality a sign
of the Marfan syndrome. This was unfortunately the case for Flo Hyman,
the captain of the 1984 U.S. Olympic Women's Volleyball Team. She was
not diagnosed with the Marfan syndrome until after her death from
aortic dissection at the age of 31 on the volleyball court. Similar
scenarios are noted in many cases. A woman who lost a brother, a sister
and a son to the Marfan syndrome remembers how she learned about the
disorder, ``It was the first day of school for my three excited sons
and the bus was just minutes from arriving. Suddenly my son fell to the
ground in convulsions and extreme pain. It took the hospital 28 hours
to determine the problema four-foot long tear in his aorta . . .'' It
is stories such as these that move us to advocate for this Committee's
support for increased research funding. Research is the only hope for
Marfan-affected individuals.
To this day ignorance still exists on how to adequately diagnose
the Marfan syndrome. Many people die at a young age in the emergency
room with a ruptured aorta because these people were never diagnosed.
One of the main problems is that there is no simple diagnostic test for
this multi-system disorder. Because most features of the Marfan
syndrome progress with age, the diagnosis is often more obvious in
older persons however, this can turn out to be deadly. Furthermore,
those persons who are considered to be candidates of this syndrome but
cannot get a precise diagnosis must also continually monitor themselves
since the 3 symptoms manifest over time. Research is desperately needed
in this area. Development of a rapid molecular diagnostic test could
save thousand of lives.
Research into the basic mechanisms of the Marfan syndrome has borne
fruit. In 1991, scientists discovered the cause of the Marfan syndrome,
an alteration of the gene that encodes the protein fibrillin-1.
Although this important finding did not lead us directly to a cure, it
has allowed scientists to focus their research to look for answers to
more specific questions. More research is needed to determine how this
mutant gene actually produces the change in human biology that leads to
this disease and is responsible for variability within the syndrome
from mild to extremely severe cases. Additional basic research in
molecular studies will also help us to fully investigate the
interaction of the fibrillin-1 gene product with other molecules in the
extracellular matrix to better understand pathogenesis of this disease.
The use of this knowledge to develop a genetic manipulation strategy to
eventually cure this disease is becoming technically feasible but is
years away. In the meantime, more immediate issues need to be dealt
with.
Clinical research is needed to identify strategies and therapies
for reducing aortic enlargement, to determine the optimal time for
surgical intervention and to predict risk for aortic dissection. This
is extremely important to save lives as noted in a recent letter to the
NMF. A young woman writes ``My cousin's 17 year-old daughter died with
a ruptured aortic aneurysm. She knew she had Marfan syndrome and had
echocardiograms every six months. Her aorta was not large enough for
surgery but she must have not read the book, because she died anyway.
She had an echocardiogram just six weeks before she died.'' It is
stories such as these that alert us to the fact that much more research
is needed in this most crucial area. It is imperative to determine what
are the clinical features and presentations of acute aortic dissection
in Marfan patients and how is this different from non-Marfan patients.
Clinical research can also offer more solutions to be used
immediately to alleviate some of the pain and disabling effects such as
curvature of the spine, dislocated lenses in the eye, and abnormalities
in the heart valves. Clinical research of treatments for back pain due
to scoliosis and more specifically for dural ectasia, the enlargement
of the membrane that surrounds the brain and spinal cord, are
desperately needed to reduce the amount of pain and suffering endured
by Marfan-affected individuals.
Funding biomedical research through the NIH is today's investment
in America's future. The technology and the science are available to
understand and ultimately cure or eradicate many of these devastating
genetic disorders. Support for the NIH is especially crucial to
unlocking the mysteries of rare diseases, such as the Marfan syndrome.
We need your support.
______
Prepared Statement of the National Medical Association
Mr. Chairman and members of the Subcommittee, thank you for the
opportunity to present the views of the National Medical Association
(NMA). I am Dr. Rodney Hood, President of the NMA, and a practicing
internist in San Diego, CA.
I am very pleased to have the opportunity to submit NMA's fiscal
year 2002 appropriations priorities to this Subcommittee. Established
in 1895, the National Medical Association is the Nation's largest and
oldest professional, educational and scientific organization
representing the interests of more than 26,000 African American
physicians and their patients, as well as nearly 100 state and local
societies. As such, the NMA has been committed to improving the health
status and outcomes of minority and disadvantaged people for more than
105 years. And while the Association has focused primarily on health
issues related to African Americans and medically underserved
populations, NMA's principles, goals and initiatives benefit all
people.
As the leading force for parity and justice in medicine and the
elimination of disparities in health, the NMA's primary goals include
improving the health status and health outcomes of minorities. In our
quest to improve healthcare, we have promoted the increased
representation of African Americans and other underrepresented
minorities in the health professions; the integration of hospitals and
universities; the protection of the rights of our patients involved
in--and increased participation in--biomedical research and the
promotion of increased access to health care services for all
Americans.
In recent years, there have been considerable discussions about
eliminating the health disparities that pervade our nation's minority
populations, to the extent that there are now national initiatives to
close the gap. In order to understand the critical need to provide
increased federal funding for programs established to address the
health status of African Americans and other medically underserved
populations, it is important to know that centuries of discrimination
against African Americans have left us with a complicated legacy of
poor health outcomes, illness, disease and death that are widespread
and pervasive. This is what authors W. Michael Byrd, M.D., M.P.H. and
Linda A. Clayton, M.D., M.P.H. call the Slave Health Deficit. The
programs supported by this Subcommittee are critical to the elimination
of health disparities. NMA looks forward to working closely with the
Subcommittee and relevant federal agencies to ensure that the
tremendous advances made through biomedical research, health
professions training and community based public health and disease
control are equally available to all Americans, particularly those who
have not fully benefited from these advances.
SUPPORT THE DEVELOPMENT OF A HEALTH POLICY AND RESEARCH INSTITUTE
Recently, NMA joined the Office of the U.S. Surgeon General and the
American Public Health Association, in partnership with the nation's
leading health providers and business leaders, to issue a Call to the
Nation to Eliminate Racial and Ethnic Health Disparities. In response
to this challenge, the National Medical Association urges Congress to
provide $1 million to support the development and implementation of a
Health Policy and Research Institute focused on achieving health parity
for African Americans. NMA is concerned that historic and current data
points to a modern-day form of ``health care racial profiling'' that
must be addressed if we are ever going to achieve parity in health
care. Recent studies are confirming what minority--particularly African
American--physicians, health professionals and caregivers have known
for years: there are significant disparities in the quality of
healthcare provided to minority patients across this nation. In
addition, there are disparities in training and professional
advancement opportunities for minority medical students and professors
of medicine; and in opportunities for equitable participation by
minority physicians in the managed care system. NMA strongly believes
that without achieving parity in the health status of African
Americans, who experience disproportionate rates of disease, morbidity
and mortality, the goals of the U.S. Surgeon General's Healthy People
2010 Initiative will remain unattainable.
NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES, NIH
Mr. Chairman, the disparate health status experienced by African
Americans and other minorities is a serious problem that threatens to
increase in complexity as the Nation, with its growing minority
population, proceeds through the 21st century. The long-term prognosis
for the elimination of health disparities among minorities is largely
dependent upon a strong federal commitment to biomedical research and
research training. However, in order to fully realize the benefits of
scientific investigation, research and research training, much more
needs to be done by the National Institutes of Health (NIH) and policy
makers to ensure that those who are suffering disproportionately, with
chronic and debilitating diseases, are able to share in these advances.
NMA is pleased that Congress supported the elevation of the Office
of Research on Minority Health at NIH to Center status, during the
107th Congress. This effort is critical to the Nation's ability to
effectively address the disproportionate cancer, and other disease,
mortality rates that exist among minorities and the underserved. This
Center will enable NIH to ensure that research targeted towards
minorities is carefully and strategically coordinated across the
Institutes and provide increased support for important minority focused
biomedical research projects. Additionally, the Center will help NIH to
address the, often systematic, oversight of minorities in clinical
trials.
NMA supports fiscal year 2002 budget increase of $3.4 billion (16.5
percent above the fiscal year 2001 funding level), for the National
Institutes of Health, to keep us on the path toward doubling the NIH
budget by fiscal year 2003. NMA sincerely hopes that as increased
funding is made available to NIH, Congress will provide adequate
funding specifically targeted towards programs to improve the status of
minority health. NMA recommends that the National Center for Minority
Health and Health Disparities be funded at a level adequate to support
the Center's expanded agenda as well as the broadened populations it
serves.
Funded at an estimated $130 million, in fiscal year 2001, more than
$90 million of the Center's budget is identified to support specific,
longitudinal research efforts and programs. That provides very little
latitude with which the Center can sufficiently support new or expanded
functions, such as Research Endowments, Centers of Excellence and the
Loan Repayment program.
Now that there is a greater recognition of the need to make
improving the health status of minority Americans a national priority,
the NMA is asking this Subcommittee to make the same commitment to
minority health research.
HEALTH PROFESSIONS TRAINING THROUGH THE HEALTH RESOURCES AND SERVICES
ADMINISTRATION (HRSA)
The NMA strongly urges the Subcommittee to substantially provide
increased funding for Health Professions Training Programs at HRSA and
supports the Health Professions and Nursing Education Coalition's
recommendation of at least $440 million for Title VII and VIII, of the
Public Health Service Act, in fiscal year 2002. Each one of the Health
Professions Training Programs, including the Training for Diversity
Programs, impact minorities, and other Americans, who reside in Health
Professions Shortage Areas (HPSA's) where there are shortages of both
primary care and specialist physicians. Funding cuts to these programs
will negatively impact the ability of minorities to pursue careers in
health, as well as the patients who benefit from their training.
Nearly all of the Health Professions Training Programs fund a
variety of programs that are essential for students and institutions
that work to improve the racial and ethnic diversity of the health
professions workforce. These programs ensure that all Americans,
regardless of their race or geographic location, have access to quality
health care services. Narrowing the health status gap that exists
between minorities and non-minorities is a national priority. Thus,
increasing the numbers of minorities in the health professions training
pipeline, as well as those serving in the health professions, is
absolutely critical to accomplishing this goal.
Numerous responsible studies demonstrate that, historically,
African Americans and other minorities are more likely than their non-
minority counterparts to serve in medically underserved areas. However,
while African-Americans represent approximately 12 percent of the U.S.
population, they represent only 2-3 percent of the Nation's medical
professionals.
Mr. Chairman, this Subcommittee has always been a strong supporter
of the Health Professions Training Programs. Your continued support is
vital to ensuring that bright, capable minority students who want to
pursue careers in the health professions have that opportunity, despite
the looming financial burdens and matriculation challenges. We
appreciate and recognize all that you have done for health professions
training in the past and urge you to be even more ardent supporters in
fiscal year 2002.
DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) RACIAL AND ETHNIC HEALTH
DISPARITIES INITIATIVE
The National Medical Association strongly supports increased
funding for the DHHS initiative to reduce racial and ethnic disparities
in health [Racial and Ethnic Approaches to Community Health (REACH)
Initiative]. Studies clearly indicate that there is a connection
between race and ethnicity and the growing health disparities and
disease burden among African Americans and other underserved racial and
ethnic minorities. With the Nation's changing demographics, it is
anticipated that minorities will comprise nearly 50 percent of the
United States population during the 21st Century. Increased support of
this initiative is critical to the future health of this nation and its
workforce.
Currently funded at $35 million, the REACH Initiative must be
funded at a level that will allow the CDC, in collaboration with OMH
and other appropriate federal agencies, to intensify its efforts to
eliminate health disparities by funding additional communities for
Phase I planning grants, Phase II comprehensive grants, training
activities under national and regional minority organizations, expanded
and enhanced technical assistance, research on social and behavioral
determinants, distance-based training, effective health interventions
and targeted health outcomes.
Additionally, in recognition of the strengths that national/multi-
geographical minority organizations can provide this program, NMA urges
the Committee to request that DHHS include such organizations among the
entities that are eligible to compete for funding without preventing
other applicants from receiving these grants. Such organizations often
have the capacity to influence communities through coalitions and
collaborative relationships that have already been established and
provide essential support to local organizations that may lack the
infrastructure needed to implement the full scale of programmatic
activities required for this important program.
The REACH Initiative is critical to enhancing efforts geared
towards disease prevention, health promotion and the delivery of care
to racial and ethnic minorities. Adequate support of this critical
program will enable us to gain a better understanding of the
relationship between race and ethnicity and health status, thereby
giving us tools that will help us to eliminate health disparities. The
development of close working relationships with minority communities is
critical to ensuring that programmatic implementation strategies and
activities, such as data collection, are culturally sensitive and
appropriate.
DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) OFFICE OF MINORITY
HEALTH (OMH)
NMA was pleased that, for fiscal year 2001, Congress provided $50
million in funding for the Office of Minority Health. However, given
the additional demands the DHHS Health Disparities Initiative has
placed on this office, such funding remains inadequate to meet the
programmatic needs of the Office. NMA strongly supports providing
adequate funding for OMH to ensure continued support for the Office's
current programs as well as the expansion of its critical efforts.
Significantly more support is needed to allow OMH to accomplish the
goals established by the Health Disparities Initiative.
STUDY ON ETHNIC BIAS IN MEDICINE
Mr. Chairman, during fiscal year 2000, Congress commissioned an
Institute of Medicine (IOM) Study on ``Ethnic Bias in Medicine.'' This
study will help provide a clear understanding of the extent to which
ethnic bias is ingrained in the practice of medicine and the education
of health professions students. Such knowledge is absolutely essential
to the effort to eliminate health disparities by 2010. NMA recommends
the Subcommittee request that the Institute of Medicine report back to
the Committee regarding the findings and recommendations of the study,
upon its completion, and urges the Committee to convene a hearing to
address this important study.
HEALTH CARE INITIATIVE FOR THE UNINSURED
In order to provide medical care to the estimated 46 million
uninsured Americans, physicians and other health care providers, who
provide this care, must often waive payment or provide care on a
reduced basis to the uninsured. In fact, studies show that minority
physicians provide disproportionate levels of care for the uninsured.
At the same time, the number of uninsured workers has increased and
changes in managed care have led to reduced Medicaid revenues. The NMA
is concerned about ensuring that uninsured Americans receive health
care coverage and that physicians are able to receive an equitable
reimbursement for their services. Therefore, we strongly urge the
Subcommittee to provide adequate support for this much-needed
initiative to strengthen health services for uninsured workers. This
initiative will provide grants, over five years, to strengthen the
ability of public and private entities, in 100 communities, to provide
comprehensive care and coordinate health care for uninsured workers.
MINORITY HIV/AIDS INITIATIVE
While new treatment therapies have led to the recent decline in
HIV/AIDS death rates, African Americans continue to die from this
disease at disproportionate rates. In fact, recent data from the
Centers for Disease Control and Prevention shows that AIDS is the
number one killer of African American men between the ages of 25 and 44
and the second leading cause of death among African American women of
the same age. And, while Blacks and Hispanics accounted for 65 percent
of AIDS cases, estimates indicate that by the year 2005, Blacks will
account for 60 percent of all AIDS cases.
Mr. Chairman, the data paints a clear picture of the devastation
HIV/AIDS has brought to minority communities. The NMA thanks the
Committee for its support of the Minority HIV/AIDS initiative during
the fiscal year 2001 funding cycle and recommends full funding in
fiscal year 2002 funding for this critical initiative to address HIV/
AIDS across the nation's racial and ethnic minority communities. The
Minority AIDS initiative is in the early stages of implementation.
Funding for this program needs to be increased to a level that will
sustain and expand its current efforts. This program's infrastructure
and capacity to address disparities in AIDS must be strengthened.
HEALTHY PEOPLE 2010
The National Medical Association views the Healthy People 2010
initiative as one of great importance. Healthy People 2010 is to be
commended for making the health objectives identical for all Americans,
rather than having different (generally lower) targets for minorities
as was the case for the Healthy People 2000 initiative. The NMA
strongly believes that all health status targets should be the same for
all Americans. We urge the Subcommittee to continue to provide the
necessary resources to the Department of Health and Human Services to
fund this important initiative.
IN CLOSING
Mr. Chairman, thank you for the opportunity to present the views of
the National Medical Association. I am pleased to respond to any
questions that you have. Our Association looks forward to working with
this Subcommittee to address the challenges we have outlined for you
today.
______
Prepared Statement of the National MPS Society Inc.
Mr. Chairman and members of the Subcommittee: My name is Les
Sheaffer, I serve on the Board of Directors of the National MPS Society
and chair the Committee on Federal Legislation. My daughter Brittany is
8 years old and is suffering with MPS III. I have submitted this
testimony to express the views of the National MPS Society regarding
the budget of the National Institutes of Health.
I wish to offer my thanks to Chairman Specter and the members of
the Subcommittee for their continued support for genetic and biomedical
research through the National Institutes of Health.
The Mucopolysaccharidosis disorders are relatively rare genetically
determined disorders caused by the body's inability to produce certain
enzymes. The lack of production of these vital enzymes results in the
interruption of the usual breakdown of specific normal molecules, which
are then stored in every cell in the body. Storage causes progressive
damage including respiratory system, bones, internal organs, nervous
system and brain damage. The most profound effect of these disorders is
the poor quality of life these children eventually endure and a
drastically shortened life span. These disorders manifest themselves in
children sometimes at birth and develop more rapidly with age as cells
become more damaged by storage.
The MPS disorders are inherited when both parents are carriers of a
recessive gene that causes enzyme deficiency in the child. The parents
maintain a 1 in 4 chance of producing a MPS child with each pregnancy.
The exception is MPSII in which the mother may be the carrier and
normally only boys are affected. The occurrence of MPS in the general
population is believed to be 1 in 25,000 births.
There are eight types of MPS disorders; Huler Syndrome MPS IH,
Scheie Syndrome MPS IS, Huler/Scheie Syndrome MPS IHS, Hunter Syndrome
MPS II, Sanfilippo Syndrome MPS III, Morquio Syndrome MPS IV,
Maroteaux-Lamy Syndrome MPSVI, and Sly Syndrome MPS VII. All MPS
disorders result in some combination of the affects listed above.
NIH funded research is a cornerstone component in the effort to
develop treatments for these deadly diseases. The grants funded by NIH
have resulted in a great deal of important information that is integral
in the quest for viable treatments for the MPS disorders. There is no
question that NIH appropriations for genetic and biomedical research
are truly an investment of federal funds.
NIH supported grants relating to MPS over the past few years have
included: bone marrow therapy, animal models, gene therapy, enzyme
therapy, molecular studies, stem cell research and other studies.
Through the support of the NIDDK, NINDS and NICHD these projects are
contributing to a better understanding of MPS disorders as well as
narrowing down possible viable treatment options for MPS. There is
still much work to be done, with adequate funding this important work
can continue.
The 14.2 percent increase for NIH in the fiscal year 2001
appropriations bill will continue to provide the essential federal
funds for future advancements. I truly hope that this commitment
continues to hold the highest priority.
Expanded research in MPS disorders is a goal of our organization
however we understand the value of basic and clinical research leading
to advances in treatments for all disease sufferers. It is also my view
that legislation and funding for programs supporting pediatric research
grant programs, collaborative research in NIH institutes, increased
access to clinical trials, training of pediatric research professionals
and multidisciplinary research and other enhancements will contribute
to conquering many crippling diseases.
The National MPS Society represents hundreds of children with MPS
and their families across the United States. The support of Congress
for genetic and biomedical research is greatly appreciated, without
this support we could not hope to find treatments for MPS and the many
other disorders that plague thousands of American children.
______
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 55-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. Our current
annual budget for research is nearly $30 million. This represents the
largest privately funded program of basic, applied and clinical
research and training related to multiple sclerosis in the world.
In this statement, we wish to emphasize the importance of NIH basic
and clinical research to all people with chronic illnesses and
disabilities and highlight our solid working relationship with NIH.
Indeed, NIH and the National MS Society collaborate to further
biomedical research and to end the devastating effects of MS. The most
recent example is the first-ever collaborative research effort between
the NIH and the National MS Society, supporting a multi-year research
effort on gender and sex-based differences between men and women with
MS and other autoimmune diseases. This effort, focused primarily at the
NIAID, serves as an outstanding model for future collaborations between
the Society and NIH, which we welcome and look forward to.
MS is a progressive, degenerative and disabling disease of the
central nervous system, unpredictable in its course, and devastating in
its effects. It affects a third of a million Americans and their
families, friends and employers. It can cause spasticity, tremor,
abnormal fatigue, bladder and bowel dysfunction, cognitive problems,
visual problems, mobility impairment, and in the worst cases, complete
paralysis and blindness. 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 progressive
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 National MS Society show that the
annual direct and indirect cost of the disease for each affected
individual as a result of MS averages $44,000--and the total cost can
exceed $2.6 million over an individual's lifetime. For all people with
MS in the United States, the annual cost exceeds $13 billion. Ending
the devastating 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.
RECENT INSTITUTE OF MEDICINE REVIEW OF CURRENT KNOWLEDGE OF MS
In April 1999, the National MS Society's Board of Directors
commissioned the National Academy of Sciences/Institute of Medicine
(IOM) to undertake a strategic analysis of the current state of
knowledge of multiple sclerosis and to evaluate strategies for future
productive basic and clinical research. The Board commissioned the $1.2
million study in the hope it would identify promising areas of research
and other strategies that had not previously been exploited, not just
for the National MS Society, but for all agencies and pharmaceutical
companies engaged in the battle against MS around the world.
The IOM assembled a committee of 14 independent scientists and
physicians from basic and clinical academic research and from industry,
with expertise in many different fields of science and medicine. Over
the course of 18 months, the committee reviewed the therapeutic
frontiers and quality of life issues, and sought comments from 45
outside consultants. A draft report was prepared, and was reviewed by
experts from outside the MS Society.
While underscoring the quality of current MS research worldwide and
the progress that has been made, the committee made 18 recommendations
that fall into three categories: research on the cause, course and
treatment of MS; disease adaptation and management; and building and
supporting the MS research ``enterprise'' (the training and
infrastructure to attract and keep the best minds focused on the
problem of MS). Many are strategies already being employed through
existing research programs at the National MS Society as well as
through research programs related to MS supported by government
agencies, including NIH, and other MS societies around the world.
Recommendations for Research on Causes, Course, and Treatments:
--Research the pathological changes underlying the natural course of
MS.
--Investigate how nerve cells are damaged, how that damage can be
prevented, and role of glial cells (such as oligodendrocytes
and astrocytes) in damage and repair.
--Identify the genes that make people susceptible to developing MS.
--Search for a possible pathogen or pathogens that trigger MS.
--Exploit the power of neuroimaging technology (such as MRI and
related technologies).
--Continue to investigate the immune system events that lead to MS.
--Develop animal models that better reflect the features of MS.
--Find strategies to protect and repair neurons and oligodendrocytes,
including research into stem cells.
--Investigate more effective ways to manage troubling symptoms of MS.
--Research the effectiveness of combination therapies.
--Develop better strategies to gain the most scientific value from
clinical trials.
Recommendations on Disease Adaptation and Management:
--Develop better tools for assessing the health status of individuals
with MS to increase the reliability and power of clinical
trials and to improve individual patient care.
--Find ways to improve the ability of those with MS to function and
adapt, and determine the most pressing needs of people with MS.
Recommendations on Building and Supporting the MS Research
Enterprise:
--Recruit new researchers to work in MS, including those from allied
fields.
--Stimulate collaborations between scientists from different
disciplines.
--Stimulate large-scale, expensive, collaborative studies.
--Increase cross-disciplinary research on ``quality of life'' issues.
--Organize research to more rapidly assess claims for new candidate
MS pathogens.
The National MS Society's Research Programs Advisory Committee is
thoroughly reviewing the report and will, for our own programs,
prioritize the recommendations that have been made, taking into account
work already being done, and develop strategies for implementing new
programs, where appropriate.
To help disseminate the study's results and plan for the future,
the National MS Society also has asked the NAS/IOM to host, at the
Society's expense, a conference in April 2001 that will bring together
organizations from around the world that fund MS research. The aim is
to maximize the dissemination of information in the IOM report, to
stimulate discussion about important strategies that might be
implemented, and to foster collaborations, where possible, in support
of MS research. NIH program officers involved in institutes that
support work related to MS will be in attendance, and it will be an
opportunity to work toward a coherent, inter-organizational effort to
further MS research.
While the IOM study will be an important reference point for the
development of future strategies in MS research, it also clearly
illustrates, through the example of MS, the need to continue the course
of doubling NIH funding over five years (fiscal years 1999-2003).
--MS is an extremely complex disease with no known pathogen or known
determinants of its severity and course, and as a consequence,
increased understanding of the cause and treatments require
research on many fronts. MS is not alone in this regard.
Neurological diseases are among the most difficult to study.
Although beneficial therapies have been developed in the last
decades for Parkinsons's disease, Epilepsy, and more recently
for Alzheimers' disease, there is still no cure for any of the
degenerative neurological diseases.
--Advances, such as improved ability to create images of the living
brain and spinal cord, new understanding of the brain's
capacity for repair, and the overall accelerated pace of new
discoveries about the cellular machinery of the brain, have
renewed the optimism of many investigators about the
possibility of developing effective therapeutic strategies for
MS and other disorders.
--On the horizon are important new therapeutic strategies: gene
therapy, stem cell transplantation and neuroprotection. Much
needs to be done in these areas, but progress in understanding
and treating virtually all degenerative neurological diseases
depends on our ability to capitalize on such new research
dimensions.
THE NATIONAL MULTIPLE SCLEROSIS SOCIETY AND THE NATIONAL INSTITUTES OF
HEALTH
National Institute of Neurological Disorders and Stroke
The National MS Society has had a long and productive relationship
with NIH, particularly with the National Institute of Neurological
Disorders and Stroke (NINDS). Our founder, Ms. Sylvia Lawry, who passed
away on February 24, 2001, helped spearhead the effort that led to the
creation of what is now the NINDS at NIH in 1950 when President Truman
signed the bill into law that established the former National Institute
for Neurological Diseases and Blindness. Since then, the Society has
had a very positive working relationship with the institute--a vital
link for us since NINDS currently is responsible for approximately 75
percent of the MS-related research at NIH.
The Society works with NINDS to coordinate grant funding. In cases
where scientists seek support for projects from both NINDS and the
Society, we have had fruitful negotiations with the agency to assure
appropriate levels of funding, without overlapping support.
Intramural scientists from NINDS serve on our scientific advisory
committees and help the Society make our research project decisions.
These outstanding scientist/physicians dedicate their volunteer time to
help the Society make its research funding decisions, and to help
ensure that the work of the Society and that of relevant parts of NIH
are in concert, and not in opposition.
National Institute of Allergy and Infectious Diseases
While MS is a neurological disease, the root problem in MS is
dysfunction of the immune system. Therefore, the Society fosters close
working relationships with the primary institute charged with studies
of the immune system, the National Institute of Allergy and Infectious
Diseases (NIAID). NIAID funds about 25 percent of the MS-related
research at NIH. The Society benefits from a variety of interactions
with NIAID. We have participated in the NIH Autoimmune Disease
Coordinating Committee that is assessing federal and non-federal
support of autoimmune disease research and is charged with plotting a
dynamic future research plan.
But perhaps the most significant aspect of our relationship with
NIAID is the first-ever collaborative initiative to fund research on
``Sex-based Differences in the Immune Response.'' This collaboration
extends the reach of the Society's targeted research initiative on
gender differences in MS by encouraging basic and clinical
investigation of sex differences in the immune response in MS and
related diseases; forging new collaborations to address existing gaps;
providing wider visibility of the problem and opportunities; and
ensuring increased support for high quality and relevant research.
--The objectives are to identify and define differences in immune
response between males and females to increase understanding
and treatment of immune-based diseases such as MS.
--The Society and NIAID will co-fund research projects relevant to
MS, but the program also will fund projects related to other
autoimmune diseases.
--Over the course of this agreement, up to $20 million could be spent
on this initiative, of which the Society plans to contribute up
to $4 million.
--A Request for Applications (RFA) has been released, and the
deadline is August 2001.
NIH FUNDING RECOMMENDATIONS
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 be of great public benefit.
We would like to express our sincere appreciation, Mr. Chairman,
for the work this subcommittee has done in the past to promote
biomedical research funding. The National Multiple Sclerosis Society
believes that in order to take advantage of current opportunities in
biomedical and rehabilitation research, Congress must increase funding
at NIH by 16.5 percent for fiscal year 2002. This would keep us on
track, and bring us another year closer, to our goal of doubling the
NIH budget over the five-year period fiscal years 1999-2003. In order
to pursue cutting edge research, the Society recommends that this
translate into parallel increases of 16.5 percent each for the National
Institute of Neurological Disorders and Stroke and the National
Institute of Allergy and Infectious Diseases, the primary institutes
that conduct nearly all of the MS-related research at NIH.
NEUROSCIENCE CENTER
Last year, Congress approved $47.3 million in funding to begin the
construction of the John Edward Porter Neuroscience Center at NIH. This
year, the National MS Society asks that Congress provide $26 million to
complete Phase I and $10.6 million to start Phase II of construction.
The Center will emphasize important cross cutting themes such as
neurodegeneration, regeneration and repair of neurons, neurogenetics
and pain research. Last year's funding for the Center was incorporated
into the NIH Building and Facilities budget, and did not affect funding
for research. Likewise, second-year funding for the Center should come
out of the same budget. Funding for the Porter Neuroscience Center
would continue to increase the pace of discovery in all areas of
neuroscience and help translate laboratory discoveries into new and
effective treatments.
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. NIH plays the major role in maintaining our country's
preeminence in the biotechnology industry and provides world-wide
leadership in health research and discovery. 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.
Increasing funding at NIH by 16.5 percent will fulfill our fourth
annual objective in the five-year effort to double the biomedical
research budget at NIH. We also recommend parallel increases for the
two institutes that conduct or fund the majority of MS-related research
at NIH: NINDS and NIAID. 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 funding the completion of the John Edward Porter Neuroscience
Center at NIH. These priorities represent an extraordinarily good use
of federal resources that will yield important biomedical and economic
benefits.
______
Prepared Statement of the National Neurofibromatosis Foundation, Inc.
The National Neurofibromatosis Foundation, Inc. (NNFF) is an
organization dedicated to improving the health and well-being of
individuals and families affected by neurofibromatosis otherwise known
as ``NF.'' The Foundation is the oldest and by far largest NF
organization in the world. I have been privileged to serve as its
President since 1986 and currently serve also as Chairman of the
International Neurofibromatosis Association.
NF is a neurological disorder that causes a variety of problems
including learning disabilities, skeletal abnormalities, disfigurement,
deafness, blindness, loss of limbs, and brain, spinal, and dermal
tumors. It also can be fatal. NF does not discriminate. It is found in
every racial and ethnic group throughout the world and affects both
sexes equally.
Neurofibromatosis is a surprisingly common genetic disorder of the
nervous system which causes tumors to grow along nerves anywhere on or
in the body. In fact, NF is the most common neurological disorder
caused by a single gene. NF is more prevalent than Cystic Fibrosis,
hereditary muscular dystrophy, Huntington's Disease, and Tay Sachs
combined.
--Two distinct forms of NF exist. NF1 is the more familiar form of
the disorder and occurs in one out of every 4,000 births. At
least 100,000 Americans of both sexes and all races have the
NF1 gene defect. NF2, which generally involves more severe
symptoms, occurs in one out of every 40,000 births.
--Symptoms of both forms of NF vary greatly but can include curvature
of the spine, enlarged heads, congenital bone defects,
blindness, loss of limbs, and tumors of the optic nerves, the
brain, and the spinal cord, as well as the vestibular nerves
which may cause deafness.
--Recent advances in NF research have linked the disorder to cancer,
brain tumors, heart disease, and learning disabilities. In
particular, NF causes learning disabilities at about four to
five times the frequency found in the general population.
There is still no way to prevent NF and there is no known cure. But
prior federal funding has helped lead to important advances.
Researchers are hopeful that a cure can be found in the next 10-15
years and believe that this timeframe possibly could be cut in half if
more research dollars are made available. The potential that NF
research holds for cancer, developmental disorders, and learning
disabilities is significant for the more than 100,000,000 Americans
with these medical problems.
I am pleased and proud that NF research has been recognized as a
model for ``Managing Science.'' It represents an effective partnership
between public agencies, most notably the U.S. Congress and the
National Institutes of Health (NIH), private organizations and The
National Neurofibromatosis Foundation, Inc., and scientists and
clinical researchers in the field who have achieved tremendous progress
by their collaboration. NF also has a particularly strong and committed
grassroots network of individuals affected by NF and their families who
are united in a common purpose to promote research and decrease the
impact of neurofibromatosis.
NF research has been so productive that scientists have moved from
cloning the NF gene to the start of clinical trials within a single
decade. Despite these successes, there is still a long way to go to
find a cure. The next steps in the neurofibromatosis research agenda
include continuing work in basic research, preparing comprehensive
natural history studies for NF, and maintaining the all-important
process of clinical trials with innovative approaches. With these goals
in mind, our first priority continues to be directing limited resources
to support research activities that will lead to better understanding,
diagnosis, and treatment of neurofibromatosis, and an enhanced quality
of life for persons with the disorder.
Congress and the Administration have demonstrated their commitment
to scientific advances in this field with funding and directives for
improved coordination at the National Institutes of Health. Funds have
been appropriated since fiscal year 1996 as part of the Congressionally
Directed Medical Research Programs (CDMRP) in the Department of Defense
(DOD) to support neurofibromatosis research by making grants available
to NF scientists worldwide through a meticulous peer review process.
CDMRP is a unique partnership among the public, Congress, and DOD to
mobilize resources and identify untapped opportunities for research
that will shape the future of health care in areas of tremendous need
including women's health, osteoporosis, and prostate, breast, and
ovarian cancer. It is a remarkable testament to the leadership of our
Armed Services. We have requested that a total of $25,000,000 be
appropriated in fiscal year 2002 under the Medical Advanced Technology
account of the DOD Research, Development, Test, and Evaluation budget
of the U.S. Army for neurofibromatosis research.
CDMRP is the largest single source of funding for NF1 and NF2
research in the world. But the support that we have received from other
sources is also of great importance to the future well-being of
individuals and families with NF. In its fiscal year 2000
appropriations bill this Subcommittee added language which expressed to
the NIH the commitment of the full Committee and of the Congress to
accelerate research to find a cure for NF. NF research has wide-ranging
impact beyond neurofibromatosis. It has linked the disease to cancer,
brain tumors, and developmental disorders. NF research has also
documented the involvement of neurofibromatosis in heart valve
formation which may lead to new opportunities and understanding of the
genetic and environmental causes of heart disease. It has demonstrated
significant promise to uncovering a molecular basis for cognitive
impairment and will have broad application to learning disabilities in
the general population. This Subcommittee has recognized that the wide
variety of symptoms of NF and the significant potential that NF
research has for other very large patient populations demands the
continued integration of neurofibromatosis research with the basic and
clinical research goals of NIH.
Today, I'm asking that you continue to provide clear directives to
the National Institutes of Health to express the continuing commitment
of the Congress to NF research conducted at NIH, and to ensure that the
level of funding to find a cure for thousands of individuals with
neurofibromatosis continues to grow every year. NF has been a
tremendous research success story for all of those who have invested in
it.
Mr. Chairman and Members of the Subcommittee, on behalf of The
National Neurofibromatosis Foundation, Inc., as well as the thousands
of children and adults with NF, I thank you for your support.
The National Neurofibromatosis Foundation, Inc., a non-profit
organization, is the leading resource on NF. NNFF's primary goals are:
--To promote and drive research to find the cause(s) and cure for NF;
--To provide support to patients and their families;
--To promote public awareness and understanding of NF; and
--To promote the development of and patient access to high quality
medical care for patients and their families.
______
Prepared Statement of the National Organization for Rare Disorders
Mr. Chairman and members of the Appropriations Subcommittee on
Labor, HHS, Education and Related Agencies, thank you for allowing the
National Organization for Rare Disorders (NORD) to submit testimony
regarding funding for the National Institutes of Health (NIH). We want
to express our deep appreciation for all the Subcommittee has done to
ensure increased funding for biomedical research--research that has
been used to reduce suffering and save lives.
The rare disease community is asking that the Office of Rare
Diseases at the National Institutes of Health (NIH) be adequately
funded to ensure that ALL Americans, not just a select few, have access
to the incredible work being done at the NIH. Today, only ten cents for
each and every person suffering with a rare disease or disorder is
allocated to the ORD. We are asking for a mere $1 for each man, woman
and child who must sometimes wait years for a diagnosis--$25 million to
``uncover new knowledge that will lead to better health for everyone.''
\1\ We are also asking that ORD be given permanent status to allow for
a diagnostic and research center, and to expand the authority of the
office because it does not currently have a permanent line item in the
NIH budget.
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\1\ Scientific Opportunities and Public Needs, National Institutes
of Health, 1998.
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NORD is a federation of approximately 140 voluntary health
organizations and over 70,000 individual patients, healthcare providers
and clinical researchers dedicated to helping people with rare
``orphan'' diseases. An orphan disease is defined by statute as any
disease or condition impacting less than 200,000 Americans.\2\ It makes
no difference whether you are male or female, rich or poor, young or
old, white, African-American, Latino, Asian or American Indian. These
diseases affect everyone.
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\2\ The Orphan Drug Act, Public Law 97-414, January 4, 1983.
---------------------------------------------------------------------------
Rare ``orphan'' diseases include such better known diseases as
Sickle Cell anemia, Tay-Sachs disease, Hemophilia, Fanconi's anemia,
Tourette Syndrome, Lou Gehrig's disease, scleroderma, etc. It also
includes obscure diseases such as Landau Kleffner Syndrome, Wilson's
Disease, mastocytosis, Canavan disease, and fibrodysplasia osssificans
progressiva (FOP). In a recent article by Thomas Maeder in the Red
Herring, FOP is described ``as one of the strangest and rarest diseases
of all, with about 125 patients in the United States.'' The body
mysteriously ``transforms its muscles, tendons, and ligaments into bone
. . .'' Internal organs are not affected and so patients can live
normal life spans unless they ``die from complications secondary to
their immobility, like pneumonia, falls, or choking on aspirated
food.'' \3\
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\3\ Red Herring, Adopting Orphan Diseases, by Thomas Maeder,
January 16, 2001, p. 130.
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Our commitment to those 125 FOP patients and the estimated 25
million other people suffering with the approximately 6,000 often
debilitating and devastating diseases is the identification, treatment
and cure of rare disorders. Approximately 5,000 of those conditions are
genetic diseases. In fact, no research is being pursued for most of
them. You can imagine the frustration many of these people feel knowing
that no one is willing or able to conduct vitally needed clinical
studies to develop new treatments or cures.
The mission of the National Institutes of Health is to ``uncover
new knowledge that will lead to better health for everyone.'' \4\ Yet,
millions are being left behind simply because they lack the knowledge
or vast resources available to many larger disease groups that allow
them to exploit the resources of the NIH. In fact, the National
Commission on Orphan Diseases (DHHS, 1989) estimated that only 30
percent of the 25 million patients suffering with rare diseases receive
a diagnosis in three to five years after the onset of symptoms. That
works out to about 7.5 million patients who are shuffled from
specialist to specialist, year after year. Fifteen percent, or 3.7
million people, wait seven years or more. Those statistics are both
frightening and unacceptable.
---------------------------------------------------------------------------
\4\ Ibid.
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To help fill that void, the Office of Rare Diseases at the NIH was
created in 1993. Its mission is to:
--Stimulate and coordinate research on rare diseases
--Compile and provide information on rare diseases to patients and
their families, as well as researchers and physicians
interested in conducting clinical research
--Co-fund with NIH Institutes and other organizations approximately
50 scientific workshops a year costing between $35,000 and
$75,000 each to
--Stimulate research where none exists
--Establish research priorities
--Develop collaborative research protocols
--Encourage the exchange of ideas among investigators, voluntary
patient support groups and NIH Institute staff to stimulate
new research, and finally
--Take advantage of scientific opportunities
--Develop and maintain the Rare Disease Clinical Research Database
describing over 1,600 research protocols.
--Develop and maintain the Medical Genetics and Rare Disorders
subfile of the Combined Health Information Database (CHID)
--Provide information collected from voluntary patient support
organizations
--Coordinate and provide liaison for the NIH with federal and non-
federal national and international organizations concerned with
rare disease research and treatment of rare diseases.
--Identify current needs in the coordination of rare disease research
in cooperation with voluntary health organizations, research
investigators and the pharmaceutical and biotech industries
--Bridge the gap between basic and translational research
--Discover opportunities to increase research resources
--Develop novel methods of research planning, coordination and
collaboration
This small office, funded with little more than $2.2 million for
the 2001 fiscal year, is the only central government resource available
to 25 million people. When you do the math, that $2.2 million works out
to be less than ten cents for each and every American suffering with a
rare disease. And while the entire NIH is enjoying increases of 14
percent and more, the ORD has seen increases of little more than three
percent.
We ask today that this Subcommittee consider the creation of one
intramural research and diagnostic center for the study of rare
diseases. The center should conduct research on rare diseases and
conditions; take advantage of emerging research opportunities; and,
augment NIH Institutes' research for neglected rare diseases.
We also ask that the responsibilities of the ORD be extended to
include:
--Oversight of the intramural research and diagnostic center for the
study of rare diseases
--Recruitment of qualified academic scientists to participate in the
grant review process for rare disease research proposals
--Support of grants for clinical pilot studies
--Collaboration with industry to develop gene vectors for gene
therapy experiments
--Expansion of existing programs to provide support for 100
scientific workshops and symposia annually, and
--Development and maintenance of a central clearinghouse for rare and
genetic disease information, written in understandable language
for use by patients and their families.
Because rare disease patients are particularly impacted by the cost
of diagnosis, treatment and ancillary support services that can reduce
a family to poverty, and because patients must often travel long
distances to academic hospitals to see the few specialists who work on
their particular disease, we also ask that this Committee consider the
creation of four regional extramural diagnostic and research centers to
expand patient outreach activities and facilitate the development of
post-doctoral training fellowships.
Mr. Chairman and members of this Subcommittee, we deeply appreciate
Congress' commitment to increase research funding for the NIH by 50
percent over the next five years because many have benefited from the
groundbreaking work already being done today. But we respectfully
request that you appropriate a minimum of $25 million to the Office of
Rare Diseases for the coming fiscal year to help the 25 million
Americans who look to you and all members of Congress for help.
Appropriating just one dollar for each rare disease patient in
America who is suffering with a rare disease, rather than the current
funding level of less than ten cents, is a win-win situation. Patients
win when their symptoms are alleviated or cured. Families win when
their loved ones no longer suffer. Society, as a whole, wins when
patients are able to return to school or work to become productive tax-
paying citizens. Pharmaceutical and biotechnology companies win when
they are able to develop new therapeutic products. The scientific
community wins when the knowledge they gain can be applied to more
prevalent diseases. And, finally, the government wins when the drain on
healthcare dollars is minimized.
I would like to leave you with a quote from Thomas Maeder's
article--``Yet even if the worries of the few were laid aside, and one
cared only about bringing the biggest benefits to the greatest number
of people, it would still make sense to study rare diseases. We
understand health through the observation of illness, and the more
illnesses we survey, the more we are likely to learn.'' \5\
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\5\ Thomas Maeder, p. 128.
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Again, thank you for your continuing commitment to the National
Institutes of Health and your recognition today of the unmet needs of
those who suffer with rare ``orphan'' diseases.
SUPPORTING DOCUMENTS
NATIONAL INSTITUTES OF HEALTH, APPROPRIATIONS--FISCAL YEAR 2001
[in thousands of dollars]
------------------------------------------------------------------------
FY 2000 FY 2001 Percent
Institute, Center, or Division Estimate Conference Change
------------------------------------------------------------------------
Cancer........................... 3,310,992 3,757,242 13.5
Heart, Lung, and Blood........... 2,026,006 2,299,866 13.5
Dental and Craniofacial Research. 269,129 306,448 13.9
Diabetes and Digestive and Kidney 1,141,176 1,303,385 14.2
Diseases........................
Neurological Disorders and Stroke 1,029,528 1,176,482 14.3
Allergy and Infectious Disease... 1,776,571 2,043,208 15.0
General Medical Sciences......... 1,353,660 1,535,823 13.5
Child Health and Human 859,079 976,455 13.7
Development.....................
Eye.............................. 450,007 510,611 13.5
Environmental Health Sciences.... 442,596 502,549 13.5
Aging............................ 687,717 786,039 14.3
Arthritis and Musculoskeletal and 349,407 396,687 13.5
Skin Diseases...................
Deafness and Other Communication 263,606 300,581 14.0
Disorders.......................
Mental Health.................... 974,470 1,107,028 13.6
Drug Abuse....................... 687,232 781,327 13.7
Alcohol Abuse and Alcoholism..... 293,173 340,678 16.2
Nursing Research................. 89,521 104,370 16.6
Human Genome Research............ 335,792 382,384 13.9
Research Resources............... 674,913 817,475 21.1
Complementary and Alternative 68,997 89,211 29.3
Medicine........................
Fogarty International Center..... 43,319 50,514 16.6
Library of Medicine.............. 215,154 246,801 14.7
Office of the Director........... 281,941 213,5812 -24.2
National Center on Minority ........... 130,200 N/A
Health and Health Disparities...
Buildings and Facilities......... 165,3501 153,790 -7.0
--------------------------------------
Total........................ 17,789,336 20,312,735 14.2
Office of Rare Diseases.......... 2,070 2,153 3.8
------------------------------------------------------------------------
\1\ Includes $40 million in advance funding from the previous year.
\2\ The Office of the Director shows a significant loss in fiscal year
2001 due to the carve-out of funds for the newly established National
Center for Minority Health and Health Disparities.
______
Prepared Statement of the National Psoriasis Foundation
Mr. Chairman and Members of the Appropriations Subcommittee: Thank
you for allowing the National Psoriasis Foundation (NPF) this
opportunity to present written testimony to the committee on the
subject of NIH appropriations, particularly as regards skin disease
research conducted through the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS).
We write to urge the committee to approve an allocation for NIAMS
of $462.2 million for fiscal year 2002, an increase of 16.5 percent
over current funding levels. This increase would further the commitment
to double the NIH budget in five years and critically increase the
ability of our nation's scientists to uncover the secrets of diseases
such as psoriasis and psoriatic arthritis.
We make this request on behalf of more than 7 million American men,
women and children with psoriasis and psoriatic arthritis--chronic,
debilitating genetic skin and joint diseases. Psoriasis is a common
disease that affects one person in forty, and yet it is a disease
without a cure and without universally effective treatments. Until a
cure or more effective treatments are found, millions of people with
psoriasis face a lifetime fighting this disease, which costs our nation
billions of dollars annually and, immeasurably, in the tragic emotional
and physical toll psoriasis can take on its victims.
Children.--I am 10 years old, and I have psoriasis. It really
itches a lot, and I can't do gym at school because it cracks open and
it hurts really bad. I look at it and I cry. . . .
Teenagers.--There are many times when I look at myself in the
mirror and just cry because I look so bad. I haven't gone swimming for
years now. . . .
I live in the South, and I wear long sleeves and pants even in the
summer to hide my psoriasis. My best friends have never seen my legs,
I'm too ashamed. . . .
The Elderly.--My medicines are so expensive, I often can't get my
prescriptions filled. Psoriasis has taken such a toll on my life. Many
times I've had to stand in the shower to soak my clothes of off my
skin.
--More than three billion dollars are spent annually on psoriasis
treatment.
--Each year psoriasis patients make approximately 2.4 million visits
to dermatologists.
--Each year several hundred people with debilitating psoriasis are
granted disability by the Social Security Administration.
--One person in five with psoriasis has disease that interferes with
their ability to perform everyday tasks, including employment
and childcare.
Psoriasis is chronic, unpredictable and often unrelenting.
Treatments may be successful for only relatively short periods of time
for only some people. The thick, red, scaly patches on any or all parts
of the body can limit daily activities and interfere with physical,
occupational and psychological functions. Skin affected by psoriasis
may itch, burn, sting and easily bleed. Physically, psoriasis can range
in severity from mild to disabling. Three-quarters of a million of the
people diagnosed with psoriasis are under the age of ten.
As many as 20-30 percent of people with psoriasis--more than one
million people--also suffer from an associated arthritic condition,
psoriatic arthritis. Psoriatic arthritis can cause significant
disability, disfigurement and impairment of quality of life. The
occupational impact of psoriasis and psoriatic arthritis not only poses
a significant economic burden for this nation but also a significant
hardship for the person with psoriasis.
Moderate-to-severe psoriasis, which affects as many as 2 million
American men, women and children, dramatically inhibits a person's
ability to maintain a normal, healthy, active lifestyle. Plaques on
large areas of their skin may restrict their movement and the pain and
itching often disrupts their sleep and their ability to work. Psoriasis
on the palms of the hands or the soles of the feet can be disabling,
preventing people from grasping a pen, holding their child, walking or
standing.
These people have psoriasis that cannot be controlled by simple
topical treatments. To manage their disease they require expensive,
inconvenient phototherapy (ultraviolet radiation) treatments in a
doctor's office, or oral systemic medications that put the patient at
risk of serious side effects. Some types of psoriasis require
hospitalization and can even be life threatening.
Emotionally, psoriasis can be devastating. The social rejection and
physical suffering of psoriasis can lead people to suicide. Many
psoriasis sufferers struggle throughout their lives with pain,
embarrassment, and shattered self-image.
Like diabetes, arthritis and heart disease, psoriasis requires
lifelong treatment. Indeed, a recent survey shows that 48 percent of
Americans would actually prefer to have heart disease, asthma or
diabetes, all of which are life threatening, instead of psoriasis.
Unlike diabetes or heart disease, however, psoriasis is not a top
priority for many researchers or pharmaceutical companies. But thanks
to focus and funding provided by NIAMS, recent research has identified
several possible sites for the genes that may cause this inherited
condition. Scientists tell us that a real cure for psoriasis will come
from these critical genetics studies.
Other research has begun to pinpoint the autoimmune component of
the disease, providing valuable targets for drug development. Many of
the same autoimmune processes that researchers have discovered at work
in diseases such as rheumatoid arthritis and Crohn's disease are also
active in psoriasis. For instance, researchers are now finding that
testing new therapies in psoriasis can be an effective way to determine
both if a new drug is safe and effective for psoriasis, and also if it
may work in these other diseases. This research must be aggressively
supported, as research in one disease will very likely benefit others.
Effective treatments and a cure for psoriasis are within reach.
Sufficient funding will enable medical science to find a cure for this
chronic, costly and devastating disease. This not only will benefit the
7 million American children and adults now suffering with this chronic
disease, but also will help the 200,000 people who are diagnosed each
year with new cases of psoriasis.
Better treatments or a cure for psoriasis will result in savings
both to the public and the government in treatment costs, lost workdays
and Social Security disability claims. Beyond these valuable dollar
measurements, an increase in federal spending for such biomedical
research will directly result in an immeasurable improvement in the
quality of life for these millions of affected Americans.
Therefore, on behalf of the members of the National Psoriasis
Foundation, and the 7 million Americans with psoriasis, we again
strongly urge you to approve $462.2 million for NIAMS, an increase of
16.5 percent over current funding levels for fiscal year 2002. This
increase will have significant health and socioeconomic benefits for
the millions of Americans who are affected by psoriasis and by other
diseases under the purview of NIAMS.
Thank you for your time and your support.
______
Prepared Statement of the National Sleep Foundation
Mr. Chairman, distinguished Members of the Subcommittee, thank you
for allowing me to submit testimony for the hearing record on behalf of
the National Sleep Foundation. I am the Medical Director for the Center
for Sleep Disorders at Doctor's Hospital in Massillon, Ohio. Since
1994, I have also been a coordinator for the Wake Up America Coalition
focusing on reducing drowsy driving crashes in Ohio.
The National Sleep Foundation (NSF) is an independent, non-profit
organization. NSF works with thousands of sleep experts, patients, and
drowsy driving victims throughout the country to prevent health and
safety problems related to fatigue and untreated sleep disorders. The
Foundation's interest in the Subcommittee's work is based on NSF's
relationship with the Centers for Disease Control and Prevention (CDC),
and specifically with the National Institute on Occupational Safety and
Heath (NIOSH) and the National Center for Injury Prevention and Control
(NCIPC). NSF is asking the Subcommittee to consider providing an
additional $1.5 million in fiscal year 2002 funding between NIOSH and
NCIPC to address sleep deprivation and fatigue-related injury in this
country.
SLEEP AND PUBLIC HEALTH
We recognize the many competing priorities that the Subcommittee
must consider as it writes the appropriations legislation for fiscal
year 2002. At first glance, sleep and fatigue issues may not appear to
be an immediate concern to the nation's health and safety. However, all
you need to do is stop and ask yourself, how do I perform when I am
tired? Have I ever driven while drowsy? Do I know someone with a sleep
disorder? Can a child learn when they can't stay awake in class? As a
sleep physician, I can tell you first-hand that insufficient sleep and
sleep disorders have a profound impact on millions of people's lives.
Sleep represents a third of every person's life, and it has a
tremendous impact on how we live, function, perform, and think during
the other two-thirds of their lives. Sleep is as vital as the air we
breathe and the food we eat, yet for many, it is last on the ``to do
list.'' Too many of us forget that lack of adequate, restful slumber
has serious consequences at home, in the workplace, at school, and on
the highway. Tragically, drowsy driving claims more than 1,500 lives
and accounts for at least 100,000 crashes in the United States every
year. Untreated sleep disorders and sleep deprivation contribute to
accidents, impaired work productivity, academic performance, reduced
quality of life, poor health, and even death.
FATIGUE AND PREVENTABLE DEATH AND INJURY
We know that tens of thousands of lives are endangered, if not
lost, each year because of fatigue. Some of them are high profile. For
instance, fatigue was cited in disasters such as the Exxon Valdez oil
spill in 1989, and the commercial airline crash in Little Rock,
Arkansas in 1999. Some of the losses do not make the evening news, but
they are tragic just the same. Just last year, nine Boy Scouts and two
Troop leaders from New Kensington, Pennsylvania, were hurt when their
van flipped over after the driver simply fell asleep at the wheel when
coming back from a camping trip. People who don't drive automobiles are
not immune from the danger. In 1998, a 6-year-old Kirkwood,
Pennsylvania, Amish girl was killed on Route 896 in Bart Township after
a driver fell asleep and smashed into the back of a buggy in which she
was riding. These crashes, along with workplace accidents, happen every
day throughout America. The tragedy is that these accidents are
eminently preventable.
Fatigue or sleep deprivation is an impairment, comparable in effect
to alcohol and drugs. New research tells us that a person who has been
awake for 24 consecutive hours demonstrates the same impairment to
judgment and reaction time as an adult who is legally drunk with a
blood alcohol concentration of 0.10 percent. Furthermore, people do not
realize that alcohol interacts with sleep deprivation to form a deadly
combination. An adult with only four or five hours of sleep may think
he or she is drinking responsibly when they have one or two drinks
after work, but in this case, what he or she does not know can kill
them or someone else. Like drugs and alcohol, fatigue needs to be
addressed as a public health issue.
RAISING AWARENESS ON SLEEP AND FATIGUE IMPLICATIONS
The National Sleep Foundation has worked with volunteers like
myself for the last decade to raise awareness, have people diagnosed
and treated, and minimize fatigue-related injuries. 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 nation's first
statewide public information and injury prevention program related to
the dangers of sleep deprivation. In March, NSF worked with over 80
diverse national organizations, state and federal agencies and more
than 350 sleep centers to hold a National Sleep Awareness Week, prior
to Daylight Saving Time, when Americans lose a precious hour of sleep.
This comprehensive, award-winning public education campaign, now in its
fourth year, generates tremendous public awareness of how good sleep
contributes to health, safety, and productivity.
While public awareness is desperately needed, a strong federal
partner with the expertise and ability to disseminate tested and proven
education, training, and injury prevention programs to communities like
New Kensington and Bart Township are needed even more. The CDC is the
partner that NSF and public health officials need to help us address
the comprehensive and complex health and safety problems related to
sleep issues.
The problem is complex and far-reaching. Complex in that, while
there are many unanswered questions about the relationship between
sleep, rest, and physical performance, the sleep research community has
established that sufficient sleep is not optional. The costs are as
immediate a disabling farm equipment accident and as debilitating as
mental disorders, seemingly unassociated with sleep patterns. Far-
reaching in that the NSF has identified several significant steps we
need to take in the public health field. Public education, physician
and police training, school-based programs, workplace safety--these are
some of the obvious program pieces that the Foundation sees a need to
initiate.
We have data telling us that lack of sleep affects the nation on
many different levels--from the airline pilot in the skies to the child
in the classroom, from the solider in battle to our farmers in the
field. But this research does no good if we cannot translate it into
education and injury prevention programs for the general public. We
believe that the CDC can and should play a vital role, working with the
sleep community, to address these problems by developing a Sleep Action
Plan that would set national priorities around sleep issues in public
health and safety. The proposed plan would better identify the specific
public health problems associated with sleep and sleep deprivation,
gather the relevant data to inform policy decisions, and recommend
policy direction and plans for implementation.
AWARENESS IN MEDICAL COMMUNITY
The National Institutes of Health estimates that more than 40
million Americans suffer from chronic sleep disorders, and millions of
others suffer intermittent sleep problems related to other medical
problems like depression, diabetes, Parkinson's Disease, arthritis, and
cancer. The overwhelming majority of these people are undiagnosed and
untreated due to a lack of public understanding of symptoms and the
training of physicians in medical schools. A Foundation survey found 58
million Americans report suffering excessive daytime sleepiness at
levels that interfere with day-to-day activities.
We believe increasing awareness on the role of sleep and the
prevalence of sleep disorders in the medical community is a crucial
element of addressing the problem. One example of how a physician
education initiative can make a difference in people's lives is from
Walla Walla, Washington. Several primary care physicians in Walla
Walla, Washington, were trained to look for and recognize symptoms of
sleep apnea, one of the more common and subtly debilitating sleep
disorders. With this training, physicians were able to diagnose and
ultimately recommend treatment to hundreds of people for sleep apnea
and other sleep disorders. A control group of physicians without
specific training only diagnosed a tiny fraction of these cases. The
moral of the story is not that there are many people with sleep
disorders in Walla Walla, but that countless Americans needlessly
suffer from sleep disorders. These people are one step away from
serious tragedy because their physicians have not been provided with
the training they need to diagnose and treat them. 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 to tackle this problem before it
gets further out of hand.
The lack of knowledge evident in Walla Walla prior to the
community-based intervention by sleep physicians was confirmed in a
recent study by the National Sleep Foundation. The NSF released data in
January 2001 that indicated that while 98 percent of primary care
physicians believe that questions about a patient's sleep should be
part of a routine checkup, only half of the doctors stated that they
ever asked such questions. Maybe more telling is that most physicians
admitted that their colleagues were likely to only talk about sleep if
the patient initiated the conversation.
VULNERABLE SUB-POPULATIONS
One of the largest groups affected by fatigue is young adults.
Twenty years of research shows us that older adolescents require about
nine hours of sleep a night to maintain proper alertness during the
day. Sleep specialists also indicate that during puberty, a shift in
the biological clock occurs, making it difficult for teenagers to get
to sleep before 10 p.m. In fact, studies have found that the average
high school student does not go to bed until midnight. This pervasive
sleepiness creates what is called a ``sleep debt,'' which profoundly
affects health, safety, productivity, and learning abilities and makes
teens the largest at-risk group for fall-asleep car crashes. Evidence
tells us that America's ``sleep debt'' is on the rise, but we, as a
nation, lack the basic resources to address this problem.
Another sub-population at risk for sleep loss is overweight
children. As the Members of the Subcommittee may know, America's
children are more obese than ever. The CDC has stated that this health
issue is reaching epidemic proportions. As a result of this alarming
weight gain, my colleagues and I are seeing more and more children
developing obstructive sleep apnea at younger ages. Left untreated,
sleep apnea leads to higher healthcare utilization and is associated
with cardiovascular disease, diabetes, stroke, depression, and other
very serious medical conditions. People with untreated sleep apnea also
have up to a seven times greater risk of falling asleep behind the
wheel of an automobile.
SUMMARY
Current CDC resources within the National Center for Injury
Prevention and Control and the National Institute on Occupational
Safety and Health 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 at NCIPC and NIOSH by $1.5
million to allow CDC to act as the coordinating body for the
development and implementation of the five-year Sleep Action Plan. This
plan will allow the NSF, CDC, and other federal agencies to develop and
distribute accurate, medically sound information and programs to local
communities. 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, health problems, and costs associated with
sleepiness and sleep disorders. We are ready and willing to take up
this challenge, but we need your help.
Thank you for consideration of this request.
______
Prepared Statement of the NephCure Foundation
SUMMARY OF FISCAL YEAR 2002 RECOMMENDATIONS
Continue the effort to double funding for the National Institutes
of Health by providing an increase of 16.5 percent, to $23.7 billion
for fiscal year 2002. Increase funding for the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) by 16.5 percent to
$1,518,443,525 for fiscal year 2002.
Prioritize glomerular injury research at NIDDK (including clinical
trials), raise professional and public awareness about glomerular
injury, and encourage more aggressive scientific attention to all
kidney diseases.
Urge NIDDK to develop programs to attract talented researchers to
the field of glomerular injury.
Mr. Chairman, and members of the subcommittee, I am pleased to
present testimony on behalf of the NephCure Foundation (NCF).
We are a relatively new, non-profit organization with a mission of
supporting research and public awareness on glomerular injury, which is
related to the filtering mechanism of the kidney. I serve as president
of the foundation, and have a son, who has had a glomerular disease
since he was eleven months old. Although he is now 24 years old and in
remission, eighty percent of those in his situation lose their kidneys
or their life by the age of five.
What is glomerular injury?
Mr. Chairman, each kidney contains about one million tiny filtering
units called nephrons. Nephrons are the key to the kidney's filtering
function, processing a constant flow of waste-laden blood, sorting out
the vital fluids, from the toxic and unnecessary elements.
When someone suffers from a glomerular disease, this vital process
is impaired. In some instances, an individual will lose protein and
sometimes red blood cells in the urine, have high cholesterol levels,
and experience severe swelling in the body from too much fluid.
Incidence of this disruptive Nephrotic Syndrome is increasing, and this
perplexes physicians who cannot identify the cause or cure.
Sometimes damage occurs to the nephrons, specifically, scarring of
the glomeruli, which are microscopic capillaries in the nephron. The
severe form of this glomerular injury is Focal Segmental
Glomerulosclerosis (FSGS). Presently, there is no treatment to reverse
this damage. FSGS can lead to end stage renal disease--total, or near
total, permanent kidney failure. Costly dialysis treatments become
necessary and kidney transplants may be required for severe cases.
The Toll of Glomerular Injury
Glomerular injury affects tens of thousands of patients in the
nation, most of them young. While it is unclear exactly how many
Americans are impacted, the incidence of glomerular injury is on the
rise. Severe forms of glomerular injury are costly to diagnose and
treat, and at this time the only relief for these patients is with
heavy medication, usually steroids, which have strong and unpleasant
side effects and only work for about 30 percent of patients.
Problems of misdiagnosis often occur with glomerular injury. Most
patients and parents have stories about the unusual length of time
between the first symptoms and diagnosis. The early signs of glomerular
injury, swollen eyelids, are often mistaken for allergic reactions.
Health care professionals don't appear to be fully knowledgeable about
this disease.
The physical changes, extreme swelling of the face and body, can
adversely affect all aspects of a young person's life. With a stronger
commitment to research and educational awareness, suffering can be
minimalized and hopefully eliminated.
There is hope for scientific breakthroughs
At a meeting co-sponsored by the NephCure Foundation, preeminent
scientists from around the world have shared their findings about the
podocyte, a major filtering cell, with tentacle-like feet. The
relationship between the podocyte and the glomerulus may be a key to
understanding glomerular injury.
Recently, researchers have discovered certain molecules that are
essential to the podocyte's function. As this becomes better
understood, scientists are hopeful of finding better ways to treat
glomerular diseases, and prevent their progression to more grave
conditions.
This spring, NIDDK will begin to establish clinical trials, which
will test various treatments for hundreds of FSGS patients. But there
is a need for more funds to strengthen the basic science behind these
studies. Researchers need to study tissue and fluids from those
patients to advance their knowledge of the molecular causes of FSGS.
What needs to be done?
Respectfully, Mr. Chairman, the NephCure Foundation urges this
subcommittee to:
--Continue the support for doubling the National Institutes of Health
(NIH) and the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK).
--Provide the funding and recommendations for the National Institute
of Diabetes and Digestive and Kidney Diseases to aggressively
pursue a scientific program which will advance research into
glomerular injury, conduct clinical trials, raise public
awareness, and recruit talented scientists to this field of
research.
Thank you for the opportunity to appear before you today.
Mr. Chairman, we hoped to have Melanie Stewart here to testify
today, but her health would not allow her to be here. Her father, Brad
Stewart, will read Melanie's statement.
My name is Melanie Stewart. I'm 13 years old and have had FSGS
since I was six. Until a year ago I spent most of my life in the
hospital or hooked up to a dialysis machine for 8 hours every day. My
kidneys finally died last year, so my dad gave me one of his. I've done
my best to keep it by taking 20 pills a day, fighting off infections,
hemorrhages, and a blood clot in my heart. The kidney my Dad gave me is
failing.
There are thousands of kids just like me who would like a chance at
a normal life. For all of us, I'm asking for your help in finding a
cure for this disease.
Thank you for listening.
______
Prepared Statement of New York University
On behalf of New York University, I appreciate the opportunity to
speak in support of public investment in basic research and, in
particular, to salute the National Institutes of Health, whose funding
of biomedical and biological research is so important to the health and
well being of our nation.
The NIH has benefited in recent years from significant budget
increases that have enabled important new NIH initiatives and funded
path breaking research conducted by both NIH as well as university-
based researchers. NIH supports established as well as junior
investigators, funds research as well as facilities and
instrumentation, and shapes emerging areas of biomedical research. NIH
funding is critical both for its direct support of research, as well as
its indirect impact in enabling extramural (university-based)
researchers to attract additional funding from other federal agencies,
private foundations, and industry for research and science
infrastructure. We at NYU applaud the national goal of doubling the NIH
budget to $30 billion by 2003, and urge Congress and this Committee to
support that proposal. A strong NIH is absolutely essential to meet the
new challenges in biology, biomedicine, and health care.
At New York University, NIH funding has supported leading-edge
research across a range of areas from molecular genetics of plants to
computer modeling of DNA structures to neural visual pathways to
language comprehension. I would like today to underscore biomedical
genomics, an important and pervasive area of contemporary biomedical
research that is a very important priority for NIH and is, as well, an
area in which NYU is well-positioned to make major contributions.
The implications of the NIH National Genome Project for America
cannot be overstated. Its scope of investigations and applications
encompasses every living thing--humans, animals, and plants--and has
the potential to revolutionize disease diagnostics and therapy,
agricultural applications, environmental conservation, and indeed, our
most cherished notions of life.
ADVANCES IN GENOMICS
The genome is the recipe or blueprint for life. During the last
decade--and particularly, during the last few weeks alone--the
unraveling of the genetic code has opened up a vast range of new
opportunities for evolutionary and developmental biologists,
neurobiologists and chemists to understand what genes are, what they
do, and how they do it. Genomics is revolutionizing biology and is
dramatically changing the way we characterize and address biological
questions. As a field which straddles biology, chemistry, and
mathematics, genomics is growing extraordinarily rapidly and
transforming these disciplines, as well as the social and behavioral
sciences.
In its first stage, the revolution in genomics was characterized by
a period of intensive development of techniques to analyze DNA, first
in simple models, like yeast, bacteria, the worm, and the fruitfly,
then in the mouse, and now in humans. The structure and function of
genes are similar in these models, making comparisons useful. The
second phase was characterized by the use of these tools to address
whatever biological question was most easily approached, given the
state of technique development. It may be described as structural
genomics--which comprises the mapping and sequencing of genomes and is
mainly driven by technology. The scientific community is now poised to
enter the third phase of the genomics revolution in which investigators
bring perspectives from other fields, like immunology, genetics, and
neurobiology to pursue investigations that are driven by hypothesis
rather than technique. This third phase is generally termed functional
genomics and uses the map and sequence information already collected to
infer the function of genes. Functional genomics integrates basic and
clinical science: the strategy is to exploit genomics approaches to
address the relationship between the genes identified in model
organisms--like the worm, or the fruitfly--and the genes responsible
for human disease states.
At New York University, we think the key issues facing genomics
today are how to translate the enormous quantities of gene sequence
data into knowledge of gene function. The answers lie, we believe, in
comparative functional genomics, an approach that looks for the
occurrence of the same genes in different species that share certain
structures or functions, and provides a powerful method for
understanding the function of particular genes. Comparative functional
genomics uses two primary modes of analysis: (1) identifying what has
been conserved over long evolutionary distances, and (2) determining
crucial differences that distinguish two closely related species. This
focus can provide the key to understanding the genetic basis of disease
states that are dependent on numerous genes and to unraveling the
complex regulatory networks for crucial biological functions.
STRENGTHS AT NEW YORK UNIVERSITY
New York University and other major research institutions are
poised to make important contributions to the next phase of genomics
research.
Studies in comparative functional genomics, the thrust of NYU
research, is necessarily multidisciplinary, and indeed, involves
multiple institutions. This approach synergizes medically related
research programs, such as those at the NYU School of Medicine and its
affiliated Mount Sinai School of Medicine, with basic science research
programs such as those at NYU's Faculty of Arts and Science. This
approach recognizes that an essential feature of emerging genomics
studies is an intimate tie of biology to computer science. The mass of
data involved in genomics strains computational capacity and analytic
tools. This has spawned a new scientific discipline, bioinformatics,
whose focus is developing entirely new algorithms for large-scale
database management, alignments, pattern recognition and data
processing for application to genomic sequences. Accordingly, genomics
studies at NYU are essentially rooted in computational investigations
at its Courant Institute of Mathematical Sciences.
NYU has substantial strengths in areas important to genomics,
including evolutionary biology, neurobiology, developmental genetics
and applied mathematics research, imaging and computation, and extends
this expertise through active collaboration and formal affiliations
with premier metropolitan area institutions, including The New York
Botanical Garden, which houses the world's largest collections of well-
characterized specimens from the plant kingdom, and Cold Spring Harbor
Laboratory, one of the world's centers for molecular biology and
genomics research. NYU Medical School has outstanding programs in
developmental genetics, molecular neurobiology, pathogenesis and
structural biology. And Mount Sinai Medical School has an
internationally acclaimed program in human genetics and has begun to
use genomics approaches to identify the origins of human genetic
disorders. The multidisciplinary perspective that characterizes
genomics--particularly comparative functional genomics--requires this
kind of concentration of strengths in biological, neurobiological, and
computational sciences, and established frameworks for
interdisciplinary and interschool collaboration.
The nation's largest private university, with 13 schools and over
49,000 students, NYU is a leading center of scholarship, teaching and
research. It is one of 29 private institutions constituting the
distinguished Association of American Universities, and is consistently
among the top U.S. universities in funds received from foundations and
federal sources. NYU encompasses a pre-eminent science faculty and
generates substantial external funding from federal and state agencies
as well as the private sector. These investigations have attracted
millions of federal dollars from the NIH, NSF, ONR, and EPA. In
addition, NYU has received major funding from the most prestigious
private foundations supporting the sciences, including the Howard
Hughes Medical Institute, the W. M. Keck Foundation, the Alfred M.
Sloan Foundation, and the Beatrice and Samuel A. Seaver Foundation.
Faculty members have, as individuals, won prestigious awards, including
HHMI Investigator, NSF Presidential Faculty Fellow, NIH Merit Awardee,
McKnight Foundation Scholar in Neuroscience, and MacArthur ``Genius''
Fellow.
RESEARCH APPLICATIONS AND NATIONAL BENEFITS
Concentrated studies in comparative functional genomics can be a
major resource for the research and development activities of academic
organizations and commercial firms; can provide a strong framework for
direct and indirect economic development in vital, high-tech
industries; and can offer benefits to our citizens from improved health
care, and technology development. Further investment in state-of-the-
art equipment, and in facilities where computer scientists, physical
chemists, and geneticists can readily interact with each other is
essential for the development of this field.
Advances in Biomedical and Other Research Fields.--The
understanding of the human genome is a field which is particularly
fertile with applications to cell biology, embryology, developmental
biology, study of cancers and many other heritable diseases,
immunology, endocrinology, neurology, and population genetics. Genomics
brings together laboratory scientists in all these fields with formerly
unrelated disciplines, and can stimulate expansion in key directions in
genetics, physical chemistry, evolutionary studies, and diagnostics.
Functional genomics research has created a need for information
processing structures that efficiently compare multiple strands of DNA,
each represented by thousands of kilobytes of data, and allow groups of
strands to be represented graphically in a way that highlights their
common elements and differences. These research challenges overlap with
the fields of machine vision, robotics, and combinatorial mathematics.
As an example, computer scientists at NYU are working closely with
molecular geneticists and business entrepreneurs to develop a library
of genomics software tools. Some of these tools are already being
considered by medical researchers for use in diagnosing tumors, which
have a genetic structure different from healthy tissue.
Biomedical Applications for National Health Needs.--An investment
in genomics research will have a heavy payoff in the nation's well-
being by advancing the frontiers of knowledge, finding new cures and
treatments for diseases, and helping to develop new diagnostic
technologies. For example, it is known that heart cells dying from
oxygen deprivation cause heart attacks. It is also known that mice are
usually more susceptible to low-oxygen heart attacks than humans. The
hearts of certain breeds of mice, such as the high-altitude deer mouse,
have the surprising genetic capability to adjust themselves to endure
oxygen deprivation. Studies conducted by genomics researchers at NYU
are focused on isolating the gene that allows this adaptation and
considering the implications for heart attack prevention. Clinical
applications like this hold enormous promise to revolutionize medicine
and our understanding of both normal development and disease. Genomics
research may lead to lifesaving technologies for diagnosis, prevention,
and cure of diseases and disorders such as diabetes, heart disease,
cancer and infectious disease. In particular, genomics science has the
potential to revolutionize the development of mass screening tests for
genetic disorders, ultimately making it possible to identify the
hereditary contribution to common diseases, predict individual
responses to drug intervention, and design drugs that are customized
for individual use.
Economic Development.--In a now familiar dynamic of university-
centered economic growth, industry draws on the faculty's
entrepreneurial energies, their expertise in training the personnel
needed to staff high-technology firms, and the fundamental scientific
research that can translate into practical applications. High-tech
firms spring up near a research university and, in turn, attract or
spin off additional high-tech firms in the same or related fields. The
interaction of scientists across firms makes the spread of information
quicker and the development of projects more rapid. Initial firms and
newer firms share a growing pool of highly trained personnel. The
expansion of the skilled labor pool makes hiring easier; the existence
of the pool attracts still more firms. Once a core of high-tech
industries locates in an area, venture capitalists identify that area
as promising. The flow of capital--a key ingredient for high-technology
growth--increases. Once the process of agglomeration begins, it can be
expected to grow on itself and become self-reinforcing.
University funded genomics studies have the potential to identify
and characterize genes of scientific and economic importance in
pharmaceutics, biotechnology, industrial processing, and agrigenomics,
including those directly applicable to human health and well-being. New
data about the function of genes has widespread commercial
applications, including, the development of novel human and veterinary
therapeutics and diagnostics; the generation of data to provide better
management of patient care, such that medicine becomes more
``customized'' as it becomes possible to determine which individuals
will benefit from which therapies; and agricultural applications,
including the development of crops with improved characteristics such
as resistance to herbicides, lack of moisture, and other adverse
conditions, or improved growth capabilities.
R&D investment in genomics is already energizing bio-technology,
pharmaceutical, biomedicine, agbiotech, computer software, and
engineering enterprises. As the genomics research base expands, there
is likely to be a generation of new commercializable technologies.
Genomics studies will meet critical needs of existing companies for
basic research leading to developments in pharmaceuticals, industrial
processing, and bioinformatics, specifically, large scale functional
genomics studies to validate genetic targets and bioinformatics studies
to guide drug discovery efforts. Genomics research is also likely to
spawn the growth of new companies, including bioinformatics and
software companies and genomics platform companies that generate
specific genomic data for product development.
Research and development funding for genomics will also spur job
growth. Academic R&D, although itself not directed towards specific
commercial application, provides the focus for attracting industry and
serving as a base for commercial spin-offs. A conservative
approximation that uses state employment multipliers maintained by the
U.S. Commerce Department's Bureau of Economic Analysis points to
immediate employment impacts of academic R&D. The BEA calculates that
each $1 million in R&D grants supports roughly 34.5 full and part time
jobs \1\ directly within the university and indirectly outside the
university as the university's expenditures ripple through the local
and state economy.
---------------------------------------------------------------------------
\1\ The multiplier is for 1995 and is based on 1987 benchmark
input-output accounts for the U.S. economy and 1994 regional data,
adjusted for 1995 inflation. See the latest (March 1997) edition of the
BEA publication Regional Multipliers: A User Handbook for the Regional
Input-Output Modeling System (RIMS II). These multipliers are
frequently used in studies of the economic impacts of individual
universities and colleges.
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Investment in genomic science is a strategic and efficient vehicle
for advancing fundamental studies in a wide variety of scientific
fields, facilitating biomedical applications that can greatly enhance
the public welfare, and energizing existing and new industries. The
commitment of this committee to support the National Institutes of
Health and its genomic initiative is greatly appreciated. We urge
Congress to continue its commitment to doubling the NIH budget. We
firmly believe that a federal investment in these and other biomedical
research fields repays itself many times over.
______
Prepared Statement of James and Margaret Nyeholt
Dear Mr. Chairman: Thank you for allowing us to testify as to why
orphan diseases--particularly Canavan disease--desperately need
government funding for medical research. Canavan disease is a model
disease for other neurodegenerative diseases such as Alzheimer's,
Parkinson's, MS, and ALS. Medical breakthroughs against Canavan disease
have the potential to also benefit so many Americans suffering from
other debilitating neurological diseases. In the case of Canavan
disease, we are dealing with a 100 percent fatal illness that affects
children. Most Canavan children do not survive their 10th birthday.
When our precious grandson (Max Randell) was diagnosed with Canavan
disease (CD) at 4 months old, our lives were forever changed. We sat in
a room with our daughter and son-in-law as our family was told that our
darling Max would disintegrate before our eyes. We were told that Max
had a fatal progressive brain disorder affecting the formation of
myelin or white matter of the brain. We learned that the childhood
victims of CD were among the most profoundly disabled people in the
world. We sat in horror as the doctors went on to tell us that because
CD is progressive, the children eventually lose all motor function,
becoming blind, paralyzed, and require feeding tubes. Canavan
children's brains slowly dissolve into a spongy mass, and even the most
elementary signals cannot reach their destination. As respiration slows
to the point where the lungs can longer function, they usually succumb
to a common illness such as pneumonia. We were also told that there was
no treatment or cure for this devastating illness.
We decided to fight back against this disease. Without government
help, our family has tirelessly fundraised for the past three years to
fund groundbreaking medical research for clinical interventions against
Canavan disease. During the course of the past three years, we have
formed a public charity devoted to finding a treatment and cure to give
these children a chance. We know there is hope, as our grandson
participated in an experimental therapy (solely supported through
fundraising efforts) where four out of fifteen children produced new
myelin. These remarkable results were confirmed by MRI's and additional
follow-up tests. Max is one of these children, and we have personally
witnessed his gaining vision (his whole world opened up) and the great
improvements in his quality of life. These improvements are now fading
and we are desperately fundraising to support another trial. We need
our government's help to fund research to give these children a chance
at the life they so deserve.
The Canavan children love life; they are very loving and social
children, although they are trapped in bodies that can respond only in
very limited ways. These children are fighters and we are fighting for
them, however without government help, by granting additional funds to
the NIH (with encouragement to grant more research funds towards
medical interventions for the children battling CD) we cannot move
forward.
We are in our late fifties. We have spent much of our retirement
savings to help to save Max and the Canavan children, and we are
exhausted and reaching out to our government for help. Both of us have
worked all of our lives, never asking for any type of government help.
We both work full time, and are devoted parents and grandparents. Most
evenings we are up until 2 AM writing fundraising letters to support
medical research to treat and cure Canavan disease. Over the past two
years, Jim has lost a kidney due to Kidney Cancer, yet we still devote
endless time to trying to save these precious children. We are fueled
by our love for our grandson (and the other Canavan victims we have
met), as well as the knowledge that advancements against Canavan
disease will truly aid in developing treatments for other
neurodegenerative diseases.
Medical research is overwhelmingly expensive to be solely funded by
private donations. Mr. Chairman, we are hopeful that (coupled with
granting additional funds to the NIH) you will also encourage them to
make an effort to grant more research funds towards therapeutic medical
interventions for the little victims of Canavan disease. Without
government grants we cannot raise the millions of dollars necessary to
continue to support crucial medical research. The Canavan children are
running out of time. By helping us to save these children's lives,
millions of other Americans suffering from degenerative brain diseases
also stand to benefit from this promising research.
______
Prepared Statement of Dr. Christina O'Connor
My name is Dr. Christina O'Connor from Lake Bluff, Illinois.
Dentistry has been my pursuit and profession for over half of my life.
I have become latex allergic by wearing latex gloves in my dental
practice. I started working in dental offices during high school and
college. After graduating from Loyola University with a degree in
psychology, I earned a Certificate in Dental Hygiene at Loyola
University and began to work as a dental hygienist. While in a
community outreach program in Newfoundland, Canada, as a hygienist,
working with poor children, I knew I could do more to help people as a
dentist. I decided to go to dental school. I graduated from Loyola
Dental School in 1985 and completed a general dentistry residency and
fellowship program at Northwestern Memorial Hospital Dental Center.
Later, I became an Assistant Clinical Professor in Dentistry at
Northwestern Memorial Hospital Dental Center where I practiced until
1994. In addition to dental patient care, I was an infection control
officer.
During my early years of practice, AIDS emerged as a national
health problem. The Center for Disease Control mandated universal
precautions to protect the practitioner and the patient from blood-
borne pathogens. The use of latex gloves, glasses, and masks as well as
protective clothing, became the standard of care. Dentists all over the
country washed and gloved their hands between every patient. In the
dental center where I practiced, latex gloves were snapping off and on
constantly as dentists, hygienists, and dental assistants moved from
patient to patient.
I noticed blister-like formations on the backs of my hand when I
used latex gloves. My hands were always red, and a rash would appear
within 24-hours of wearing latex gloves. The rash forced me to change
to non-latex gloves. Even though I had no direct contact with latex, I
developed labored breathing, wheezing, itchy swollen eyes, and asthma
when others used powdered latex gloves in my presence. My shortness of
breath, coughing, and labored breathing lasted for several hours after
work. I needed inhaled bronchodilators to help me to breathe.
I was forced to retire in June of 1997 when a leading latex
allergist diagnosed me as having Type I Ig-E cell-mediated latex
allergy after a skin prick test for latex allergy was performed. The
allergist explained that the skin rashes experienced earlier were
evidence of a Type IV allergy to latex. He explained that continued
exposure to airborne latex from powdered gloves even after I stopped
using latex gloves myself, caused the conversion to Type I (immediate
hypersensitivity) latex allergy. My choices were very limited. I was to
avoid latex and its dust to save my life. With a deep sense of loss, I
retired from my dental profession.
Today, I know I am not alone. There is an epidemic of latex allergy
emerging. Scientific literature estimates the prevalence of latex
allergy among healthcare workers to be between 8 percent to 17 percent,
and between 1 percent to 6 percent in the general population. One study
sponsored by the American Dental Association Health Foundation
estimated average prevalence among dental professionals to be 6.2
percent based on a health-screening program in 1994 and 1995. The
American Dental Association has not released latex allergy data from
this study for the subsequent years 1996, 1997, 1998, and 1999 so it is
difficult to ascertain whether the prevalence is increasing or
declining among this group of dental professionals. The American Dental
Association refuses to disclose this current prevalence data on latex
allergy.
Today, I know powdered latex gloves produce ``secondhand latex
exposure'' similar to the secondhand smoke phenomena seen in the
tobacco industry. The Food and Drug Administration in 1997 issued a
report on glove powder stating that the latex protein can bind with
glove powder and become airborne causing respiratory allergic reactions
in latex allergic individuals and ``may represent an important agent
sensitizing non-allergic individuals.'' An article in the Journal of
the American Medical Association in 1997 stated: ``Since the
institution of universal precautions, latex glove protein has emerged
as a major allergen in health care facilities. Airborne exposure of
health care workers to latex protein allergens may be increased by the
use of powdered gloves compared with non-powdered gloves.''
The National Institute for Occupational Safety and Health Alert in
1997 and the Occupational Safety and Health Administration Technical
Information Bulletin in 1999 on latex allergy have sought to shed light
on this emerging health problem and to offer preventive strategies in
the workplace. The American College of Allergy, Asthma, and Immunology
launched a nationwide campaign to educate healthcare workers and other
high-risk groups like spina bifida patients, individuals who have had
multiple surgical or medical procedures, to the risk inherent in latex.
The Allergy Report from the American Academy of Allergy, Asthma,
and Immunology of March 2000 reported: ``The increasing prevalence of
latex allergy is related to more frequent use of latex gloves resulting
from universal precautions and changes in the manufacturing process.''
The Allergy Report also stated: ``During the past five years,
increasing evidence has accumulated that latex allergy has become a
major occupational health problem, which has become epidemic in scope
among highly exposed healthcare workers, and in others with significant
occupational exposure.'' With all of these people affected with latex
allergy, there are still many questions left unanswered. We need
research for all areas of latex allergy including its prevention,
immune mechanism, disease progression, and the long-term outcome of
latex allergic patients.
Latex allergy is a life long, life threatening condition. The
biggest risk is anaphylactic shock--a life threatening condition
resulting in hives, severe swelling of the eyes, mouth, lips, and
tongue as well as difficulty breathing, severe chest tightness, and
potentially, respiratory failure. Since 1989, the Food and Drug
Administration has received reports of 15 deaths due to latex enema
cuffs. During the past ten years, the Food and Drug Administration has
received over 2,000 reports of adverse events involving latex gloves.
Five deaths were included in these reports, in addition to the fifteen
deaths previously reported. There is no treatment, no cure for latex
allergy.
I live a life of avoidance. All I can do is avoid all latex
products that may be inhaled, ingested, or touched. This presents a
sizable challenge for all latex allergic patients and me since there
are over 40,000 products that contain natural rubber latex. I avoid
paramedics, hospitals, doctor's offices, and dental offices that use
latex gloves and latex medical equipment. An accidental or inadvertent
exposure with latex can push me into anaphylactic shock so I carry with
me two epinephrine injectable pens, latex-free gloves and latex free
emergency medical equipment. A hospital emergency room or an ambulance
where latex gloves have been used can be a real threat to me. In my
community, police officers and paramedics arrive on an emergency scene
already wearing latex gloves.
Access to safe medical care is impossible for the latex allergic
patient when latex gloves and latex medical equipment are all that is
available. There is no time in an emergency medical situation to
determine whether a patient is latex allergic. There are safe and
affordable latex alternatives that offer protection from blood-borne
pathogens for the patient and the healthcare deliverer. Latex-free
products should be the standard of care for the emergency medical
service, fire fighters, and law enforcement.
I want to ask for your help in financial support for awareness, for
education, and for research into all aspects of latex allergy. Research
is desperately needed to formulate a multi-disciplinary approach to
latex allergy prevention involving hospitals, public health
departments, emergency medical systems, government regulatory agencies,
and manufacturers. Research is desperately needed to develop treatment
models for those who suffer from this emerging public health problem.
Finally, research is desperately needed to determine the best means of
educating employers and employees to phase out latex gloves from work
settings and tasks that do not involve contact with infectious
material. There is widespread and indiscriminate use of latex gloves in
non-medical industries such as food handlers, daycare workers, auto
mechanics, housekeeping personnel, and hair stylists.
______
Prepared Statement of the Pancreatic Cancer Action Network, Inc.
Mr. Chairman and Members of the Subcommittee. My name is Paula Kim,
I am the Co-Founder & Chairman of the Board of the Pancreatic Cancer
Action Network or ``PanCAN''. In March of 1998, my father died from
pancreatic cancer--a mere 75 days after diagnosis. Watching the
devastation of this disease first hand, and encountering a severe lack
of information, scientific progress and advocacy support, sparked my
desire in 1999 to co-found PanCAN. PanCAN is a non-profit organization
and the first and only national patient based advocacy group for
pancreatic cancer. Our staff of three is also fueled by grass roots
volunteers across the country focused on creating awareness and
eradicating pancreatic cancer.
BACKGROUND
Increased emphasis on and awareness about pancreatic cancer is a
good idea for several reasons. First, there is currently no early
detection method for pancreatic cancer. Second, treatment options are
severely limited and generally palliative. The term ``palliative'' is
what doctors say when they try to make someone comfortable while he or
she is dying from a disease. Third, there is an extreme shortage of
trained investigators working specifically on pancreatic cancer
research.
Pancreatic cancer is one of the most aggressive cancers and has one
of the lowest survival rates among all cancers. Pancreatic cancer is
the 4th leading cause of cancer death for men and women in this
country. About 29,000 Americans are diagnosed with it each year, and
nearly the same number die each year from this horrible disease. The
incidence of the disease among African Americans remains
disproportionately high. The typical pancreatic cancer patient has
vague symptoms, presents with metastatic disease and has a life
expectancy of less than one year following diagnosis.
Our nation's experience in dealing with AIDS, breast cancer and
prostate cancer has shown us that a focused effort and targeted funding
can have an enormous impact on combating a specific disease. Pancreatic
cancer has not attracted much interest because so many of the people
most familiar with it are in cemeteries and because the research
funding has been the lowest funded per mortality of all major cancers.
These facts, along with the recently completed National Cancer
Institute (NCI) Progress Review Group Report for Pancreatic Cancer,
clearly identify the overdue and desperate need to accomplish the
following: develop Centers of Excellence, recruit and train
investigators, develop public and professional education about the
disease, support research that identifies new methods of detecting and
treating pancreatic cancer, and provide patient support and information
services.
On behalf of PanCAN and the thousands of pancreatic cancer victims
and their loved ones, I summon your help and seek to impress upon you
that ongoing emphasis and action is needed to address the magnitude and
urgency of this disease. In order for the research community to make
progress on battling pancreatic cancer, we must first get them to the
starting line. Your consideration of our recommendations will help
facilitate this process, and we are extremely grateful for your
support.
FISCAL YEAR 2002 NEED
For fiscal year 2002, we urge your support in promoting the
specific actions with the following Federal agencies:
National Cancer Institute
We commend the National Cancer Institute (NCI) for its report on
the Pancreatic Cancer Progress Review Group. This report is an agenda
for action to attack pancreatic cancer. Pancreatic cancer is the 4th
leading cause of cancer death for men and women.
However, we remain concerned that while there are over 29,000 new
cases of pancreatic cancer each year, 28,900 people die each year from
this disease. It is one of the most fatal forms of cancer but is one of
the lowest funding priorities at NCI. We seek your support to direct
the NCI to develop, and present to the Congress within six months, a
professional judgment budget in line with the NCI Progress Review Group
for pancreatic cancer research for fiscal year 2003-fiscal year 2008.
In addition, we seek your support to direct the NCI to develop an
initiative for the awareness of pancreatic cancer that includes both
scientific and lay materials to disseminate, thus helping to increase
public and research awareness about this tragic disease. Also, we would
request that NCI consult closely with the research community,
clinicians, patient advocacy groups and Congress in the preparation of
this report.
National Institute of Diabetes & Digestive & Kidney Diseases
We seek your support to urge the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) to collaborate with the National
Cancer Institute on mutual research areas and awareness programs for
the scientific and lay communities. We specifically seek your support
in directing the NIDDK to establish translational research activities
to understand the inter-relationships of pancreatitis, diabetes, and
pancreas cancer.
Centers for Disease Control and Prevention
We seek your support to encourage the Centers for Disease Control
(CDC) to work with the National Cancer Institute to determine possible
areas of collaboration in epidemiology, translational research, and
awareness and registry programs. We would further request that you
direct the CDC to report back to you on initiatives in these areas when
they testify before Congress next year.
It would be most beneficial if the CDC would also plan and
implement awareness programs for orphan cancers for patients and
community oncologists. Patients diagnosed with these cancers, such as
esophageal, kidney, liver, multiple myeloma, pancreatic, and stomach,
currently have lowest life expectancy rates of all diagnosed cancers,
yet community oncologists generally lack specific knowledge about these
malignancies. We suggest that the CDC develop comprehensive community
oncologist education programs to help doctors better identify orphan
cancer symptoms and make more accurate, timely diagnoses.
Because pancreatic cancer adversely affect ethnic minorities and
the medically underserved, we suggest that the CDC to determine the
feasibility of integrating hematological (leukemia, lymphoma, multiple
myeloma), digestive system (liver, pancreatic), and genitourinary
(kidney, genital) cancers screening and awareness programs into
existing activities.
Lastly, we would encourage the CDC registries program to establish,
along with the states, high-risk registries for the digestive cancers
(liver, pancreatic) and other cancers with significantly low survival
rates following diagnosis.
CLOSING REMARKS
Mr. Chairman and Senators on the Subcommittee, thank your for
allowing me this opportunity to outline specific action steps which our
Federal agencies may take to further increase the awareness about
pancreatic cancer and accelerate efforts to eradicate this terrible
disease. I have attached draft legislative language for your
consideration so that the recommendations outlined above may be
incorporated in the Fiscal 2002 Labor/HHS/Education Appropriations
report.
Best wishes and good health to each of you.
______
Prepared Statement of the People for the Ethical Treatment of Animals
Chairman Specter and Members of the Subcommittee: People for the
Ethical Treatment of Animals (PETA) is the world's largest animal
rights organization, with more than 700,000 members. We greatly
appreciate this opportunity to submit testimony regarding fiscal year
2002 appropriations for the National Institutes of Health. Our
testimony will focus on nicotine experiments on animals.
Studies on human beings have documented the effects of smoking on
disease processes, organ systems, longevity, and other health issues.
Conducting nicotine experiments on animals is duplicative, meaningless,
and wasteful.
We would like to request that the subcommittee include report
language ensuring that no funds under the appropriations act shall be
used for nicotine or tobacco experiments on non-human animals.
In fiscal year 1996, the National Institutes of Health funded 123
grants totaling $28,099,418 for research primarily concerned with
cigarette smoke or nicotine. Forty percent of these grants (49 of the
123) involved non-human animals. As you know, funding is limited for
medical research and health programs. Why waste American tax dollars on
nicotine experiments on animals when those funds could be much better
spent on prevention programs, public education, or clinical studies?
CURRENT AND ONGOING NICOTINE EXPERIMENTS ON ANIMALS FUNDED BY THE
NATIONAL INSTITUTES OF HEALTH
Pregnancy studies
In his abstract entitled, ``Fetal nicotine exposure effect on
primate lung,'' researcher Eliot R. Spindel writes, ``The deleterious
effects of maternal smoking during pregnancy are all too well
established,'' including ``overwhelming evidence that smoking during
pregnancy directly and adversely affects lung development.''
However, ``overwhelming evidence'' did not stop Spindel from
applying for and receiving a four-year grant from the National
Institute of Child Health and Human Development to conduct nicotine
experiments on pregnant rhesus monkeys. In order to ``characterize the
effects of chronic exposure to low levels of nicotine throughout
pregnancy on lung development and subsequent pulmonary function,''
pregnant monkeys were given doses of nicotine ``consistent with that of
smokers.'' Afterwards, the infants' lungs were examined to determine
the effects of chronic nicotine exposure on lung development and
function.
Spindel hopes that his study will ``provide an important tool in
smoking control and will begin to better explain the link between
maternal smoking and altered neonatal respiratory function,'' despite
the fact that evidence already in existence has failed to alter the
``unfortunate prevalence of smoking during pregnancy.''
Eliot Spindel is with the Oregon Regional Primate Research Center
in Beaverton, Ore. His project started in February of 1999 and is
scheduled to conclude in January 2004. (Source: NIH Computer Retrieval
Information on Scientific Projects, June 2000.)
The public health message that can be gleaned from this
experiment--that pregnant women should not smoke--was already well
established before these experiments began. From a public health
standpoint, it is difficult to avoid the conclusion that these
experiments are, at best, costly and trivial. Experiments like these
are frightening, stressful, and ultimately fatal for the animals
involved. If helping human babies is our goal, such experiments should
be replaced with aggressive public health measures.
Addiction studies
In his abstract entitled, ``Stress induced reinstatement of
nicotine-seeking behavior,'' James D. Valentine writes, ``Many believe
that stressful life events can contribute to drug use in humans, and,
recently, animal models have been developed for studying this
phenomenon.''
According to Valentine, ``exposure to unavoidable stressors can
dramatically affect drug-seeking behavior, including relapse to drug-
seeking in drug-free animals.'' While a variety of ``drugs of abuse''
have been used to examine this phenomenon, the ``effect of unavoidable
stress on nicotine-seeking behavior has yet to be examined.''
As a result, Valentine applied for and received a grant from the
National Institute on Drug Abuse to, ``determine if exposure to
unavoidable stress will reinstate nicotine-seeking behavior in rats.''
Valentine is with the Minneapolis Medical Research Foundation, Inc.
His project started in July of 1998 and was scheduled to conclude in
June 1999. (Source: NIH Computer Retrieval Information on Scientific
Projects, June 2000.)
``Unavoidable stressors'' as mentioned above can involve a wide
variety of obstacles, dangers, and painful experiences which the
animals are forced to endure before they are killed. Stressors in past
nicotine experiments have included:
--placing animals on a hot plate heated to 126 degrees F;
--starvation until between 15 and 20 percent of the animal's body
weight is lost;
--placing an animal in a large, deep tank filled with a paint and
water mixture (so that the animal cannot see what is beneath
him). The animal's task is to struggle to find a clear
Plexiglas ``escape platform'' below the surface on which he can
stand to keep his head above the liquid.
One has to question the value of Valentine's experiment, as it has
already been well established that nicotine is a highly addictive
substance, and there is little doubt that rats would seek it just as
they do cocaine, heroin, and other highly addictive substances. It
would have been more helpful to society if this money had been used to
create addiction treatment programs for people for whom stress has
already ``reinstated nicotine-seeking behavior.''
Other examples
Here are two more examples of the numerous grants that NIH has
bestowed for nicotine experiments on animals.
A grant of $183,628 in 1996 was given to Hakan W. Sundell at
Vanderbilt University to use nonsedated, mechanically ventilated lambs
to see if ventilation effects of nicotine exposure relate to SIDS in
humans. (This grant was given despite our knowledge that maternal
smoking accounts for about 30 percent of all SIDS cases.)
A grant of $152,166 in 1996 was given to Leonard L. Howell at Emory
University to see how caffeine and nicotine interact in rhesus monkeys.
Again, clinical studies of human beings who smoke and use caffeine
would be far more relevant.
SUMMARY
Nicotine experiments on animals cause immeasurable suffering and
divert funds from efforts that benefit human health, such as aggressive
prevention, education, and addiction treatment programs.
Please include language in the report accompanying the fiscal year
2002 Labor-HHS-Education Appropriations bill stating that none of the
funds under this appropriations act shall be used for nicotine or
tobacco experiments on non-human animals.
If you do not feel that that would be possible, please consider
including the following stipulations in the report:
If any of the funds under this appropriations act are to be used
for nicotine or tobacco experiments on non-human animals, the following
criteria must be met before the experiments can begin:
--The secretary or administrator of the agency responsible for
conducting the experiment shall provide a report to Congress
with the following information:
--the purpose of the experiment and a description of its
anticipated benefits to human health;
--the number and species of animals required;
--the source from which the animal(s) will be procured;
--an explanation of why the number of animals cannot be reduced;
--a detailed description of what procedures the animal(s) will
undergo;
--a rating (none, mild, moderate, or severe) and detailed
description of the pain and distress that the animal(s)
will experience;
--a statement of whether or not analgesics or other painkillers
will be used (and if not, an explanation of why not);
--a description of all elements in the experiment considered to be
stressors to the animal(s);
--an explanation of what will happen to the animal(s) after the
experiment is completed;
--a list of all databases that were searched to ensure that the
experiment is not replicating any experiment(s) that has/
have already been performed;
--a statement that, in the opinion of the secretary or
administrator, there is no possible way that the topic of
the experiment could be researched without using live
animals, and an explanation of why this is, including an
explanation of why this experiment would be more relevant
to human health effects than human clinical studies or
epidemiological studies would be;
--a description of any non-animal research methods that are
currently under development which may be a viable
alternative to the experiment, and an explanation of why
the experiment cannot be postponed until that non-animal
method becomes available for use;
--this report shall be published in the Federal Register for a 60-day
period during which the public may submit comments;
--this report, along with all public comments submitted during the
aforementioned 60-day period, shall be reviewed by the House
Appropriations Committee and by the Senate Appropriations
Committee. After reviewing the report and the public comments,
a two-thirds majority in each committee must vote to approve
the use of funds for the experiment.
If the above three criteria are not met, the funds may not be used
for the experiment.
Without these stipulations, tax dollars will continue to be wasted
on duplicative, meaningless experiments that cause animals to suffer
and that do nothing to benefit human health.
Thank you for your consideration of our request.
______
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 2002 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. We are grateful to you for your recognition 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
30 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. Two population
research centers are based in Pennsylvania--one in Philadelphia and one
in State College.
Demographic research covers many issues important to our nation,
such as retirement, health disparities, 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 are not always 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 at NIH. We would like to take this
opportunity to share with you information concerning the implications
of an aging population, the effects of welfare reform on children and
families, immigration, fatherhood and adolescent health.
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
NICHD has a well-established and successful population research
program. NICHD is currently funded at $977 million with approximately
$74.5 million of that budget dedicated to research funded through the
Demographic and Behavioral Sciences Branch in fiscal year 2000. 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 immigrants, and adolescent health.
Fatherhood
In the past, males were often overlooked in research that focused
on family formation and functioning. 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.
The Fragile Families Study has found that unmarried fathers are
generally engaged with their children at birth and aspire to be good
fathers, contrary to popular myth. Additionally, in cases of divorce, a
NICHD funded research 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.
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 nationwide have dropped dramatically, yet we know
very little about how these changes affect these children and families.
NICHD supports a wide range of research that examines how communities,
families and children are interrelated and adapting to changes in
social policy.
The Fragile Families and Child-Well Being Study started collecting
data in 2000 and will continue through 2004. Initial waves of data will
inform research on prenatal care, mother-father relationships,
expectations about fathers' rights and responsibilities, attitudes
toward marriage, social support and knowledge of local policies and
community resources. The Three Cities Study of Welfare Reform and the
Well-Being of Children studies the effects of the 1996 Welfare Reform
bill on children in three cities, Boston, San Antonio, and Chicago,
over the period 1999-2002.
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 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.
Adolescent Health
Our knowledge of adolescent health has been greatly enhanced by the
National Longitudinal Study of Adolescent Health (Add Health), a
comprehensive study, begun in 1994, of adolescent health and well-being
funded by NICHD and 17 other federal agencies. This study provides
information that is valuable to parents, educators, researchers and
policy makers.
One of the key findings from the Add Health study is that ``family-
connectedness'' plays a central role in protecting adolescent health:
adolescents who feel loved and cared for by their parents and are
satisfied with their family relationships are least likely to smoke,
drink or use illegal drugs; least likely to become sexually active at a
young age; least likely to be emotionally distressed or contemplate
suicide; and least likely to engage in violence.
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. The 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.
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 $786 million, with approximately $115
million of that budget dedicated to the Behavioral and Social Research
Program--training, career development, and demographic, economic and
epidemiological research in fiscal year 2000. 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). You have been a solid supporter of
this important prospective panel study since its inception in the early
1990s, Mr. Chairman, and we would like to express our gratitude for
your support.
Health and Retirement Study (HRS)
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. Last year HRS completed its most recent round of data
collection, HRS2000 and even now is preparing to go back into the field
in 2002.
In 1993, the HRS was augmented by the AHEAD (Asset and Health
Dynamics of the Oldest-Old) which sampled the cohorts born before 1924,
individuals who are the oldest-old segment of our population with high
rates of chronic disease, disability, and health care costs. The older
AHEAD respondents were interviewed in 1995, 1998 and 2000. 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 referred to as 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 of time and financial help across generations of the family.
The HRS has been used by NIA-supported researchers to explore issues
related to health, work and retirement; mid-life savings and the
prospects for late-life economic security; cognitive changes, health
insurance coverage, and use of health care services. Data provided by
very old respondents has been useful for studying how families
redistribute their resources across generations, and how these flows
interact with public sector transfers. These data inform policy
decisions on initiatives such as Medicare/Medicaid coverage for long-
term care and prescription drug benefits.
Health Status and Health Care
We have long known that Americans are living longer than ever
before, and new research shows that older Americans are living better
as well. A recent NIA funded study showed that while memory problems
increase with age, fewer seniors were identified as having significant
memory or cognitive problems in 1998 than in 1993. Both men and women
experienced improvements over the past decade and marked improvements
were seen in those over 80. These preliminary findings suggest that
severe cognitive impairment in the senior population has declined over
time. This study follows earlier studies which demonstrated a similar
decline in the rates of physical disability among the senior
population.
The majority of Americans over age 65 rates their health as good or
excellent and report being satisfied with the health care they receive,
still, many seniors face chronic health conditions or disabilities and
utilize home care to help meet their needs. While most home care is
still provided informally and free of charge by family and friends,
recent trends have shown a decline in the use of informal home care as
the sole means of help and an increase in the use of combined formal or
paid assistance and informal help. The 1990s saw dramatic increases in
paid home health care for older Americans. There are however a number
of disparities in home care assistance. Research has found that on
average, disabled women receive significantly fewer hours of informal
care than disabled men, and the dominant provider is a child rather
than the spouse, as it is for men.
Federal Forum on Aging Related Statistics
Finally, PAA and APC are interested in and support the current
efforts to strengthen the Federal Interagency Forum on Aging-Related
Statistics. The NIA leads the forum, which is a consortium of nine
federal agencies working together to improve the quality and usefulness
of data on older Americans. The forum is an example of NIA's interest
in supporting NIH's innovative endeavor of streamlining federal
databases, making data accessible to the business community as well as
academic researchers. Only by allying these two groups can the data
produced by the federal government be brought to bear on the real
problems of older Americans.
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 continue five year
process of doubling of NIH's by 2003. PAA and APC continue to support
an even distribution of any increase in funding for NIH among the
institutes.
______
Prepared Statement of the Pulmonary Hypertension Association
INTRODUCTION
Mr. Chairman, thank you for the opportunity to submit written
testimony regarding fiscal year 2002 appropriations for the National
Institutes of Health (NIH) and the Centers for Disease Control and
Prevention (CDC).
I am Linda Carr, president of the Pulmonary Hypertension
Association (PHA). Pulmonary hypertension is a rare disorder of the
lung in which the pressure in the pulmonary arteries (the blood vessels
in the lungs) rises above normal levels and may become life
threatening. Symptoms of pulmonary hypertension include shortness of
breath with minimal exertion, fatigue, chest pain, dizzy spells and
fainting. When pulmonary hypertension occurs in the absence of a known
cause, it is referred to as primary pulmonary hypertension (PPH). This
term should not be construed to mean that because it has a single name
it is a single disease. There are likely many unknown causes of PPH.
Secondary pulmonary hypertension (SPH) means the cause is known.
Common causes of SPH are the breathing disorders emphysema and
bronchitis. Other less frequent causes are the inflammatory or collagen
vascular diseases such as scleroderma, CREST syndrome or systemic lupus
erythematosus (SLE). Congenital heart diseases that cause shunting of
extra blood through the lungs like ventricular and atrial septal
defects, chronic pulmonary thromboembolism (old blood clots in the
pulmonary artery), HIV infection, liver disease and diet drugs like
fenfluramine and dexfenfluramine are also causes of pulmonary
hypertension.
Pulmonary hypertension is frequently misdiagnosed and has often
progressed to late stage by the time it is accurately diagnosed.
Pulmonary hypertension has been historically chronic and incurable with
a poor survival rate. However, new treatments are available which have
significantly improved prognosis. Recent data indicate that the length
of survival is continuing to improve, with some patients able to manage
the disorder for 15 to 20 years or longer.
As PHA's new president, I come to this role standing on the
shoulders of giants. Ten years ago when three women with PH founded
this organization, there were less than 50 diagnosed cases of this
disease. It's not that PH wasn't there, so much as it was--for the most
part--unknown, even in the medical community.
Today, PHA includes:
--Over 3,600 patients, care givers and medical professionals
--An international network of over 50 support groups
--An active and growing patient hotline
--An new and fast-growing research fund
--A host of numerous electronic and print publications
Centers for Disease Control and Prevention
PHA applauds the subcommittee for its leadership in encouraging CDC
to initiate a professional and public PH awareness campaign in the
fiscal year 2001 Labor, Health and Human Services, and Education (L-
HHS) conference report. Currently, we are working with officials from
the CDC to establish this important program that will better inform
health care professionals and the general public about PH, its
symptoms, and treatment options. The following is a description of the
specific initiatives we hope to launch in collaboration with CDC:
(1) Increasing awareness and understanding of PH among primary care
physicians is critically important, because these practitioners are
usually the first point of contact for PH patients. If the primary care
doctor misses the symptoms, then the chance for early diagnosis depends
upon the intuition and persistence of the patient. They have a chance,
if they aggressively pursue diagnosis by trained and aware specialists.
If they are not aggressive, or if they are in a health plan that
requires their general practitioner to prescribe the referral, they are
more likely to go undiagnosed until it is too late to control their
illness.
We are in the process of developing and implementing several
targeted strategies for reaching these providers, including:
--Written and video diagnostic tools for placement on the Internet.
--A postcard mailing to be sent to all primary care physicians,
medical schools and medical centers in the United States
drawing attention to the new web resources.
--A simplified and visually attractive version of the proper
diagnostic procedures, which will be sent in a second mailing
to all primary care physicians, medical schools and medical
centers in the United States.
--Advertising in publications general practitioners are likely to
read. The emphasis will be the urgency and ease of early
diagnosis and the ease of accessing diagnostic tools via the
Internet.
--A CD-ROM that explains pulmonary hypertension from a variety of
angles. We would like to make 100,000 of these available to the
medical community and patients through our web site on an as
requested basis and at conferences and through targeted
mailings.
(2) Due to the advancements in treatment for PH, it is important
that we also focus on educating cardiologists and pulmonologists. Our
strategies for reaching cardiovascular specialists include:
--Publication of the first Pulmonary Hypertension Journal focused on
educating a wider population of doctors on issues related to
the diagnosis and treatment of the illness.
--Placement of additional detailed information on the illness on the
web. The PH Journal and other publications will promote this
availability.
--Expansion of PHA's international conference on pulmonary
hypertension (the largest PH conference in the world).
--Expansion of PHA's Pulmonary Hypertension Resource Network. This
program is focused on increasing awareness of PH among nurses
through peer education.
(3) Finally, PHA is committed to increasing PH awareness among the
general public through the development of the following initiatives:
--A series of 10, 15 and 30 second public service announcements on
PH. These PSAs will be in both audio and video form.
--A PH media relations manual.
--An organ donation awareness campaign (unfortunately, many PH
patients die before finding a suitable organ donor).
--Expansion of PHA's web-site.
We look forward to working with CDC to implement these and other
initiatives aimed at increasing awareness of PH in the United States
and throughout the world. For fiscal year 2002, we encourage the
subcommittee to continue to support the important mission of the CDC
with an overall appropriation of $5 billion (an increase of $1.1
billion over fiscal year 2001) Moreover, we urge you to provide $1
million (level funded from fiscal year 2001) within CDC's
Cardiovascular Disease program (a division of CDC's Chronic Disease
Prevention program) for the continuation of the PH public and
professional awareness initiative.
National Heart, Lung and Blood Institute
Mr. Chairman, PHA commends the leadership of the National Heart,
Lung and Blood Institute (NHLBI) for its support PH research. Just last
year, two separate groups of scientists funded by NHLBI simultaneously
identified a genetic mutation associated with primary pulmonary
hypertension.
The two groups, independently reported that defects in the BMPR2
gene, which regulates growth and development of the lung, are
associated with PPH. The defects in the gene lead to the abnormal
proliferation of cells in the lung characteristic of PPH.
Although both studies suggest that only one gene is involved in
PPH, neither group identified the defects in BMPR2 as the sole cause of
PPH. In addition, since many people without a known family history of
PPH get the disease, both groups suggested that other factors may
interfere with control of tissue growth. Now that we have pinpointed a
gene, we can focus on learning how it works. Hopefully, that
information will enable researchers to devise better treatments and
perhaps eventually a preventive therapy or cure.
Mr. Chairman, PHA would like to thank you and the subcommittee for
your leadership in support of funding for the National Institutes of
Health. Moreover, we would like to thank the subcommittee for the
inclusion of committee recommendations on PH research at NHLBI in the
fiscal year 2002 Senate L-HHS report. For fiscal year 2002, PHA joins
with the Ad Hoc Group for Medical Research Funding in supporting a 16.5
percent increase for NHLBI. Finally, we request that the subcommittee
provide $25 million in fiscal year 2002 for PH research at the
institute to enhance basic research, gene therapy and clinical trails
of promising new therapies.
CONCLUSION
Mr. Chairman, once again thank you for the opportunity to present
the views of the Pulmonary Hypertension Association. We look forward to
continuing to work with you and the subcommittee to improve the lives
of pulmonary hypertension patients. If you have any questions or would
like additional information please do not hesitate to contact me or the
PHA National Office in Silver Spring, Maryland (301) 565-3004.
______
Prepared Statement of the Research Society on Alcoholism
The Research Society on Alcoholism appreciates the opportunity to
present its views about the importance of alcohol research within our
nation's priorities for health and improving the quality of life. The
Research Society on Alcoholism is a professional society of over 1,200
members who are committed to understanding and intervening in the
negative consequences of alcohol through basic research, clinical
protocols and epidemiological studies.
The cost of alcohol abuse and dependence on American society and
individual lives is staggering. The cost to the nation is estimated at
approximately $185 billion annually. Not only are the fiscal costs real
and powerful, but alcohol misuse is costly in other ways as well.
Specifically, it is associated with 50 percent of all homicides, 40
percent of all motor vehicle fatalities, 30 percent of all suicides and
30 percent of all accidental deaths. Furthermore, the cost to
productive life is astounding. A recent review of estimates of
Disability--Adjusted Life Years (a means of estimating loss in
productive daily living) indicates that alcohol abuse and dependence is
the fifth leading cause of lost life-years in the United States. It
follows conditions which are not unrelated from alcohol abuse and
dependence such as ischemic heart disease, traffic collisions, certain
cancers and HIV/AIDS. For some subgroups, such as the American Indians
with whom I work, the costs associated with alcohol misuse may be even
higher and may be directly linked to some of the major health problems
in this group such as hypertension and diabetes.
Despite, or perhaps because of, the widespread impact and effects
of alcohol, it has been impossible to identify a single cause or
solution to alcohol's negative consequences. There is no doubt that
alcohol abuse and dependence are affected by a number of factors
including genetic risk, socio-cultural characteristics, psychiatric and
general health co-morbidity and individual differences in the acute and
chronic effects of alcohol. The only hope for better understanding and
thus more effective education, prevention, intervention, treatment and
long-term recovery is through research.
The Research Society on Alcoholism wants to thank the Congress, and
this Committee in particular, for the strong support the National
Institute on Alcohol Abuse and Alcoholism (NIAAA) received in current
fiscal year. Because of this committee's historic support of the growth
of biomedical research, and the investment in NIAAA more specifically,
the alcohol research community has made tremendous strides in
clarifying many of the factors which we now know contribute to risk to
alcoholism and the overall negative consequences of alcohol abuse and
dependence. Specifically, because of this support we have seen
significant advances in disentangling the genetic influence and role of
family history in alcohol dependence, we have begun to identify the
critical components of effective treatment, and we have begun to
explore effective integrated treatments for those who suffer from the
most severe forms of the disease. Given our scientific understanding of
alcoholism only a few decades ago, this is truly remarkable progress.
While recognizing these advances, we believe the need to continue
the effort and national commitment to this issue. The leadership of the
Research Society on Alcoholism has framed a set of priorities which, if
adequately supported, will move the field significantly forward in all
areas of NIH priority.
Specifically, we strive to more accurately evaluate risk for
alcohol dependence and measure the effectiveness of early education and
primary prevention efforts. In regard to treatment, we are moving
toward a systematic evaluation of integrated treatments which engage
more traditional therapies, the use of pharmacotherapies (such as
naltrexone) and the use of support and self-help groups. This focus
does not imply that all alcoholics require this level of treatment, but
it is important that we develop more effective treatments and develop
means of identifying those who are most in need of these interventions.
Newer pharmacotherapies are now available which significantly decrease
drinking and increase sobriety while still newer medications (e.g.,
acamprosate; now under study) appear to reduce craving and thus enhance
the newly recovering person's ability to sustain abstinence.
Technology has its place in these identified priorities, as well.
Imaging and computerized testing will provide the means for
understanding the underlying brain systems and enable a more standard
assessment across research protocols. Relatedly, the developing imaging
techniques will facilitate our understanding of ``craving'' and provide
the means for its characterization as the ``brain event'' that it is.
Basic studies of alcohol metabolism with specific subgroups
continues to be a critical area for study. Additionally, neuroimaging
studies including brain electrophysiology, positron emission tomography
and developing technologies will shed light on new ways of
conceptualizing the disease process of alcohol dependence and
facilitate the distinction between alcohol abuse and dependence.
The Human Genome project as well as the Consortium on the Genetics
of Alcoholism Study (the latter funded by NIAAA) have turned our
nation's attention to the role of genes and the possibility of
discovery. Alcoholism will not easily lend itself to a simple genetic
application. It can, however, be better described, the subtypes better
identified and the differential risk for various interactions between
alcohol and other medical disorders better clarified through these
technologies.
Finally, we endorse the concern regarding health disparities as it
is experienced in the research of substance abuse and dependence. We
know that there appears to be an increased risk within certain ethnic/
racial groups, however, it is unclear why this risk exists and whether
or not the risk applies to all members of the group. For example, the
Indian Health Service estimates that the age-adjusted alcoholism
mortality rate for American Indians is 63 percent higher than the rate
for all other races in the U.S. Initial studies with other racial
groups have identified specific strengths and vulnerabilities which are
important to further explore if we are to address the needs of all
Americans.
Recommendations.--Given the costs of alcohol abuse/dependence as
well as the significant advances over the past decade, we believe that
the continued support of NIH and NIAAA are imperative to our nation's
quality of life. Consistent with the Ad Hoc Committee for Biomedical
Research Funding, the Research Society on Alcoholism is urging that
Congress support a $3.4 billion, or 16.5 percent, increase for NIH in
fiscal year 2002 to maintain the congressional campaign to double the
NIH budget by 2003. Within this funding level, the RSA requests a $79.4
million, or 23 percent, increase to NIAAA for fiscal year 2002; this
increase would bring the total NIAAA budget to $420 million. This
request represents the professional judgement of the alcohol research
community and is justified on the basis of the historic under funding
of NIAAA, significant advances in recent years, and the promise of
opportunity in the present.
The Research Society on Alcoholism thanks you for the opportunity
to present our views.
______
Prepared Statement of Rotary International
Chairman Specter, Senator Harkin, members of the Subcommittee,
thank you for this opportunity to testify on behalf of Rotary
International in support of the polio eradication activities of the
U.S. Centers for Disease Control and Prevention. The effort to
eradicate polio has been likened to a race--a race to reach the last
child. As in any race, discipline, commitment, and endurance are
indispensable elements of success. This race requires the discipline to
remain focused on the task at hand. We cannot allow ourselves to become
complacent as we approach the finish line. Though we sense victory is
near, a single misstep could jeopardize all we have accomplished. This
race requires the commitment to make the sacrifices necessary to
achieve success. The major partners in the global polio eradication
effort have joined with national governments around the world in an
unprecedented demonstration of commitment to this historic public
health goal. As the initiative runs its course, total victory can only
be guaranteed through continued and unwavering commitment to the goal
of a polio-free world. This race requires the endurance necessary to
maintain our current activities. We cannot allow the great distance we
have traveled to diminish our resolve. Though we may be weary from a
race that has now lasted years, our adversary is weakening. The victory
over polio is closer than ever!
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, 125 nations around the world were polio-
endemic. At the end of 2000, only 20 countries remained polio-endemic.
The Western Hemisphere has now been polio-free since 1991, and the
Western Pacific region was certified polio-free in October of 2000.
Europe will be the next block of countries to be certified polio-free
with the rest of the world anticipated to be certified polio-free not
later than 2005. Today polio is confined only to Sub-Saharan Africa,
parts of the Middle East, and South Asia (Exhibit A).
Thanks to the polio eradication efforts over the last decade, more
than 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 148 polio laboratories has been established.
Significant challenges lie before us. Continued political
commitment is essential 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 to
polio-endemic countries. Access to children is needed, particularly in
countries affected by conflict. Truces must be negotiated if National
Immunization Days (NIDS) are to proceed in these countries. Polio-free
countries must maintain high levels of routine polio immunization and
surveillance. 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 1.1 million business and
professional leaders in 163 countries. In the United States today there
are some 7,500 Rotary clubs with over 380,000 members. All of our clubs
work to promote humanitarian service, high ethical standards in all
vocations, and international understanding.
In the United States, Rotary has formed the USA Coalition for the
Eradication of Polio, a group of committed child health advocates that
includes Rotary, the March of Dimes Birth Defects Foundation, the
American Academy of Pediatrics, the Task Force for Child Survival and
Development, and the U.S. Fund for UNICEF. These organizations join us
in expressing our gratitude to you for your staunch support of the
international program to eradicate polio. Over the past several years,
you have steadily increased your appropriation for the polio
eradication activities of the Centers for Disease Control, and for
fiscal year 2001 you appropriated a total of $91.4 million for the
CDC's overseas polio eradication efforts. This investment has made the
United States the leader among donor nations in the drive to eradicate
this crippling disease.
FISCAL YEAR 2002 BUDGET REQUEST
For fiscal year 2002, we respectfully request that you provide
$106.4 million for the targeted polio eradication efforts of the
Centers for Disease Control and Prevention, a $15 million increase from
the fiscal year 2001 funding level. This $15 million increase is
necessary to respond to the rising cost of oral polio vaccine, which
has increased to as much as $.096 from $.072 per dose. 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 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 National Immunization Days.
Without the additional $15 million, we may not be able to purchase
sufficient levels of oral polio vaccine, 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' public and
private sectors currently spend 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, more than 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 3,500
reported cases in 2000 (Exhibit B). 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 150 million in a single day in
India.
--Approximately 3,500 confirmed polio cases were reported to WHO for
2000. As a result of routine polio immunization, NIDs and
house-to-house mopping-up activities, there has been a 99
percent decline in reported polio cases since 1998.
--Of the three types of wild poliovirus, Type 2 has not been seen
since October of 1999, and appears to have been eradicated.
--All polio-endemic countries in the world have conducted NIDs. The
achievement of successful NIDs and implementation of APF
surveillance in Somalia and Sudan shows that polio eradication
strategies can be implemented even in countries affected by
civil unrest.
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 2001, you appropriated a
total of $91.4 million for the CDC's global polio eradication
activities. Because of Congress' unprecedented support, in 2001 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 16 technical staff
to assist UNICEF and polio-endemic countries. This includes 30
CDC staff provided directly on assignment to WHO and UNICEF.
--Providing nearly $50 million to UNICEF for approximately 530
million doses of polio vaccine and $9 million for operational
costs for NIDs in some 60 countries in Asia, Eastern Europe,
the Middle East and Africa. A 33 percent increase in polio
vaccine costs in 2001 has reduced the number of doses that can
be procured with CDC funds. Many of these NIDs would not take
place without the assurance of the CDC's support.
--Providing over $13 million to WHO for surveillance, technical staff
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.
--Training virologists from all over the world in advanced poliovirus
research and public health laboratory support. The CDC's
Atlanta laboratories serve as a global reference center and
training facility.
--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. CDC has
the leading specialized polio reference lab in the world.
--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. 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. Additionally, the
unprecedented cooperation between the public and private sectors serves
as a model for other public health initiatives. 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.
RESOURCES NEEDED TO FINISH THE JOB OF POLIO ERADICATION
The World Health Organization estimates that $1 billion is needed
from donors for the period 2001-2005 to help polio-endemic countries
carry out the polio eradication strategy. Of this total approximately
$550 million has been committed, leaving a funding gap of approximately
$450 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 funding gap.
The United States' commitment to polio eradication has stimulated
other countries to increase their support (Exhibit C). Belgium, Canada,
Germany, and Italy are among those countries that have followed
America's lead and made 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. In 1999 the United Kingdom announced two grants
totaling U.S. $94.6 million for polio eradication efforts in India and
Africa. In the last year, the Netherlands has committed nearly $50
million for global polio eradication. The Dutch Government pledged $8.4
million for surveillance in India, Pakistan and the Democratic Republic
of the Congo, followed by a year-end allocation of $40 million for
surveillance in 2000.
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, $402
million has already been allocated for polio vaccine, operational
costs, laboratory surveillance, cold chain, training and social
mobilization in 122 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.
Your discipline, commitment and endurance have brought us to the
brink of victory in the great race against this ancient scourge. Polio
cripples and kills. It deprives our children of the capacity to run,
walk and play. Other great health crises loom on the horizon. The work
you have done and that which we ask you to continue will ensure that
today's children possess the strength and vitality to run the race on
behalf of future generations.
Thank you for this opportunity to present written testimony.
______
Prepared Statement of the Scleroderma Research Foundation
The Scleroderma Research Foundation appreciates the opportunity to
submit this written statement urging Congress to provide increased
federal support to the National Institutes of Health (NIH) for the
aggressive pursuit of basic research programs on scleroderma.
The Scleroderma Research Foundation has, on its own, mobilized and
developed a high quality scientific and medical research program
dedicated to the pursuit of a cure for scleroderma, all without
government support. The advances made by the Scleroderma Research
Foundation have led to the identification of several key areas of
investigation that could further focus the path to a cure, if only the
research receives the support it deserves. As this progress has
developed, significant government help has been sorely lacking. A
commitment from Congress and the NIH is needed to leverage and build
upon the key advances that have been achieved, and to bring us closer
to saving lives.
We ask for a commitment by Congress to provide concentrated federal
support at the NIH to aggressively pursue basic research programs on
scleroderma. A goal of $10 million annually would constitute a minute
portion of total health research spending, yet would more than double
the current available funds for scleroderma research. More important,
this level of funding would support needed advances in the current
state of knowledge in the field.
The Scleroderma Research Foundation also calls for an appropriation
of $23.7 billion for the NIH in fiscal year 2002. This 16.5 percent
increase represents the fourth step toward doubling the NIH budget by
fiscal year 2003. This continued growth will allow the NIH to realize
the promise of new technologies and better meet the challenges of
improving the health of the nation's people.
Scleroderma is a serious, but overlooked and under-funded disease.
It is conservatively estimated to afflict at least 350,000 Americans
(many organizations estimate as many as 750,000 scleroderma patients in
the United States, given recent advances in diagnostics). More than 80
percent of scleroderma patients are women, between the ages of 30 and
50, but scleroderma is also a disease that strikes--and kills--children
and men. Yet, the NIH is projected to fund scleroderma research this
year at only $4.74 million.
Scleroderma is a chronic, degenerative disorder that leads to
vascular deterioration, tissue loss, and fibrosis in the body's
connective tissue. There are different types of scleroderma, but even
in the disease's limited forms, scleroderma can be disfiguring,
debilitating, and painful. In its most serious form, systemic
sclerosis, the disease causes severe damage and serious complications
for the body's digestive, respiratory, circulatory, and immune systems.
Almost 70 percent of patients with systemic sclerosis die in less than
seven years after their initial diagnosis.
A diagnosis of scleroderma is all the more chilling for patients
when they learn there are no effective treatments for the vast majority
of cases and no cure for the disease. Scleroderma has a particularly
complex phenotype affecting different organs. The failure of a long
list of medications in scleroderma patients points to the critical need
for basic scientific research to unlock the mysteries of this disease.
When the Foundation was created in 1987 there were no diagnostic
tools for scleroderma, and research on the disease was almost
nonexistent. In a little over a decade, the Scleroderma Research
Foundation has successfully met the challenge of raising pivotal funds,
brought together top scientists to direct and execute cutting edge,
basic research programs and targeted the most direct approach to
finding a cure for scleroderma. The $5 million invested in research by
the Scleroderma Research Foundation has all come from private sources,
especially scleroderma patients, their friends, families and
supporters.
The Foundation's research programs have made critical discoveries
in the three major areas of pathogenesis of scleroderma: the immune
system, blood vessels, and extracellular matrix.
--Autoantibodies have been found that are unique to scleroderma
patients and are not found in other autoimmune diseases.
Further research is needed to understand why and how these
antibodies form.
--The study of blood vessel pathology has identified key receptors
that mediate the vascular hypersensitivity known as Raynaud's
phenomenon, a primary feature of scleroderma and a precursor to
extensive vascular damage.
--Hardening of the skin, or fibrosis, is another prominent feature of
scleroderma. Investigators have identified a decrease in an
inhibitory molecule that may explain the mechanisms leading to
excessive hardening of the skin.
--New genetics studies have been initiated to determine if there are
host factors that can influence the onset of scleroderma.
Advances in genetics present new opportunities for scleroderma
research, including the development of scleroderma genotypes
and the search for genetic mutations or aberrations.
These discoveries point the way to future investigations that
cannot be carried by the Scleroderma Research Foundation alone. We have
made significant progress, but have far to go in understanding this
disease. We have made enough progress, however, to know that
scleroderma is a solvable problem. The Scleroderma Research Foundation
has been successful in bringing together the appropriate scientists in
specialized fields. The advances in molecular and cellular sciences
have created tremendous potential, compared to ten years ago, for
discovering the triggers of this disease. Today, the right people and
technologies are in place to cure scleroderma. Your partnership is
needed to secure the necessary resources to get the job done and start
saving lives.
Thank you for providing the opportunity to present this statement.
The Scleroderma Research Foundation welcomes any questions or requests
for further information.
______
Prepared Statement of the National Task Force to End Sexual and
Domestic Violence Against Women
The Sexual Assault, Rape and Incest Issues Committee of the
National Task Force to End Sexual and Domestic Violence Against Women
urges the Senate Appropriations Committee, Labor, Health, and Human
Services, Education Subcommittee to appropriate the $80 million for
Rape Prevention and Education Grants authorized under the Victims of
Trafficking and Violence Protection Act of 2000, specifically:
Title IV--Strengthening Education and Training to Combat Violence
Against Women
Sec. 1401 Rape prevention and education.
Congress made a commitment by passing the Violence Against Women
Act of 2000 to provide increased resources to sexual assault service
providers and to continue and expand rape prevention programs. FULL
FUNDING OF THIS GRANT PROGRAM IS CRITICAL TO CONTINUING THIS IMPORTANT
WORK.
The funds authorized under the Act are used for prevention and
education programs for the following:
--Educational seminars
--Operation of hotlines
--Training programs for professionals
--Preparation of informational material
--Education and training programs for students and campus personnel
designed to reduce the incidence of sexual assault at colleges
and universities
--Education to increase awareness about drugs used to facilitate
rapes or sexual assaults
--Prevention/education efforts targeting underserved communities and
individuals with disabilities
Rape Prevention and Education funding also supports the National
Sexual Violence Resource Center, a project of the Pennsylvania
Coalition Against Rape. The Center is a clearinghouse of information
and resources related to all facets of sexual violence, including
stranger and non-stranger rape, drug-facilitated rape, statutory rape,
sexual harassment and child sexual abuse. The Center collects and
facilitates resource-sharing among organizations across the country.
Every month, the Center receives over 100 requests for information from
state and territorial sexual assault coalitions, local rape crisis
centers, government entities, allied national organizations and the
media.
Sexual violence is a critical social epidemic confronting our
Nation:
An estimated 302,100 women and 92,700 men are forcibly raped each
year in the United States (Tjaden, Patricia and Thoennes, Nancy,
November 1998).
13.3 percent of college women indicated that they had been forced
to have sex in dating situation (Johnson, I., Sigler, R., 2000.
``Forced Sexual Intercourse Among Intimates'').
In a 1998 study of which school students, over half of all males
and 42 percent of all females believed that sometimes it is
``acceptable for a male to hold a female down and physically force her
to engage in intercourse'' (Warshaw, 1998).
The majority of rapes nationwide are perpetrated against young
women and girls. Full funding of the Rape Prevention and Education
grants is an indispensable tool for keeping women and girls safe from
sexual violence. Thank you for giving us the opportunity to present our
perspective.
______
Prepared Statement of the Sjogren's Syndrome Foundation
SJOGREN'S SYNDROME
Sjogren's (SHOW-grins) syndrome is one of the most common
autoimmune disorders, striking 4 million Americans. Ninety percent are
women, and most are middle aged and older when diagnosed. However,
Sjogren's crosses all ages, ethnic groups, and socioeconomic
boundaries. Anyone can have this disease. There is no cure and few
treatments beyond palliative measures, yet the suffering and disability
is tremendous, and the potential consequences serious.
In Sjogren's, the immune system turns against one's own body.
Moisture-producing glands are primary targets, resulting in hallmark
symptoms of dry eyes and dry mouth. These symptoms alone can be
devastating. If not treated, dry eyes can lead to corneal ulcers and
abrasions and potential blindness. Untreated dry mouth can lead to
rampant cavities and loss of teeth. Once teeth are lost, those with
Sjogren's have few options--dentures often don't work in a mouth that's
dry and susceptible to infection. Problems with swallowing, digestion,
and reflux are also common in Sjogren's.
But Sjogren's syndrome is not confined to symptoms of dryness.
Sjogren's can affect any organ in the body, including the skin, lungs,
pancreas, and liver, endocrine glands, and gastrointestinal, vascular,
nervous, and urinary and reproductive systems. Autoimmune thyroid and
autoimmune liver disease are not uncommon in one who has Sjogren's.
Sjogren's can cause debilitating joint and muscle pain and fatigue, and
maternal antibodies associated with Sjogren's can cause heartblock in
babies of mothers who have the disease. Finally, Sjogren's can result
in lymphoproliferative disorders, or lymphoma, there being a 44 times
higher rate of non-Hodgkins lymphoma in those who have Sjogren's.
WHAT IS IT LIKE TO LIVE WITH SJOGREN'S SYNDROME
A Sjogren's syndrome patient, Kim Vaughn, wants to tell you what
it's like for her to live with the disease. She writes:
``I'm a model, a former Mrs. Georgia America, and the mother of two
energetic boys. I'm a wife, a daughter, a sister. But what I know you
can't see if you were to look at me is that I have a disease called
Sjogren's syndrome. This disease has not only affected my life, but it
has affected the lives of every member of my family.
Sjogren's syndrome is an autoimmune disease. While it can affect
any organ in the body, it targets the moisture producing glands. Can
you imagine your eyes being constantly dry because you can't produce
tears? Can you imagine what it's like not to have saliva, so that you
can't eat many common foods? Can you imagine being so exhausted every
night that you collapse at 8:00 p.m.? It's hard enough to raise two
boisterous boys with a normal energy level.
I live with pain.--Joint and muscle pain are a big part of
Sjogren's syndrome. I know it's hard for people to understand the
impact of pain and fatigue, and it might seem minor to have dry eyes
and dry mouth, but these symptoms are devastating. To have your eyes
and mouth dry all the time, be susceptible to infection, always have to
carry and use moisturizing eyedrops and drinking water wherever I go .
. . these things greatly affect quality of life.
I live with fear.--Will I be one of the 5 percent with Sjogren's
who gets lymphoma and leaves a wonderful husband and kids behind,
because this disease doesn't seem urgent or important enough? Because
my symptoms can't be seen? When I was pregnant, I had to worry if my
child would have fetal heartblock because of my Sjogren's. Would I have
the energy to take care of an infant, to nurture a baby from infancy to
adulthood? Are my children genetically susceptible to this disease?
I was one of the lucky ones because I was diagnosed quickly--it
only took a year and a half. Sjogren's might be a common autoimmune
disease, but most women suffer for years before being diagnosed. When
we're finally diagnosed, there's not much to be done for it but treat
the symptoms, many times ineffectively or only for a little while. Why?
The Sjogren's Syndrome Foundation greatly appreciates your
continued support of federally funded medical research. Please help us
to take advantage, now, of the escalating breakthroughs in medical
research to unlock the mysteries of autoimmunity--particularly the
mysteries of Sjogren's syndrome.''
QUALITY OF LIFE
Quality of life might be hard to measure, but it is critical to
one's well-being, to the ability to live a full life without
potentially crippling psychological and physical anguish and affecting
employment and enjoyment of life.
Quality of life is surely compromised when one is frequently in
pain and suffers from severe fatigue, spends hours in doctors' offices
and undergoing testing, and when one faces fear of complications. Other
quality-of-life issues include having one's eyes and mouth hurt all the
time and succumb to infection, not always being able to focus clearly,
swallow easily, go out to eat, or talk for long periods or take a walk
because one's throat and mouth get dry quickly. The incidence of
depression increases when quality of life diminishes.
Most of the palliative treatments to which patient Kim Vaughn
refers are over-the-counter medications, which are not reimbursable by
insurance. This creates an additional financial burden on those who
suffer from Sjogren's syndrome. High costs of medical testing, frequent
doctors' visits to a range of specialists, and prescription
medications, might or might not be largely covered by insurance. Those
who are chronically ill face lifetime insurance caps and often find
work options reduced.
Let's take a look at the impact of just one of the common symptoms
of Sjogren's--dry eye: A year 2000 study by Dr. David Sullivan of The
Schepens Eye Research Institute, Harvard Medical School, found that
more than 37 percent of employed dry eye patients say their symptoms
interfered with their work and more than 60 percent say symptoms
interfered with leisure activities. The same 60 percent say their
lifestyle has been adversely affected, and of these, more than 40
percent suffer from depression. Some 40-45 million Americans, most of
them women, have dry eye, and the numbers double from those in their
50s to those 75 and older.
THE NUMBERS
Autoimmunity is a huge problem. Autoimmune diseases make up the
third largest disease category in the United States, affecting 5
percent of the population, and include some 70 to 80 diseases, many of
which overlap and share symptoms. Sjogren's syndrome is one of the most
prevalent.
The numbers of those with Sjogren's syndrome are probably higher
than scientists estimate. It is often unrecognized and, thus,
underdiagnosed and misdiagnosed. Among the reasons--the disease crosses
many medical specialties, symptoms often seem unrelated, and Sjogren's
can mimic or co-exist with other autoimmune organ-specific disorders.
Dryness might be attributed incorrectly to the aging process. Other
complaints of fever, joint and muscle pain, and fatigue, and the waxing
and waning of symptoms are sometimes seen as insignificant to
physicians not well informed about Sjogren's syndrome. It often takes
years of seeking help before a diagnosis is made; a recent national
health study showed an average of 6.3 years from onset of symptoms to
diagnosis. Add to this the fact that the baby-boomer generation is now
entering the age of high risk for Sjogren's, and the number of patients
will surely increase.
RESEARCH OPPORTUNITIES
Scientists still do not know the cause of Sjogren's syndrome, but
recent developments have taken us a step closer to understanding the
disease and finding new treatments. For example, inflammatory
infiltrates have long been believed to cause decreased tears and saliva
in Sjogren's, but new research shows there might be a very different
reason. The glands that produce moisture might, in fact, be rendered
dysfunctional by specific autoantibodies, antibodies that target one's
own self. These antibodies targeting muscarinic receptors have been
found to cause dry eyes and mouth in animal models. Similar antibodies
have been implicated in other Sjogren's complications, such as fetal
heartblock in babies born to mothers with Sjogren's.
Other new developments will enhance both clinical and basic
Sjogren's research. The first is an agreement by an international
committee of scientists working to develop standards for defining the
disease, an effort organized and supported by the Sjogren's Syndrome
Foundation.
Second is the potential for a registry on Sjogren's and inclusion
of Sjogren's in a database on autoimmunity. NIDCR is looking into the
possibility of starting a database specifically on Sjogren's, and NIAMS
and NIAID already fund one for autoimmune disease, but Sjogren's was
not originally included. They are now working with us on ways to do
just that. If Sjogren's is included in databases, we'll be better able
to understand the genetics of Sjogren's and autoimmune diseases and
other aspects of autoimmunity.
We're in a new information age, and it's time we gathered data that
will answer the critical need for epidemiological studies on Sjogren's.
We have no statistics!
Finally, as an NIDCR scientific workshop held last fall on
Sjogren's demonstrates, we can inspire groups of scientists from around
the world to work together, develop the means to share research, and
expand our base of knowledge.
There's a wonderful Sjogren's Syndrome Clinic housed at NIDCR, and
indeed, most of the research on Sjogren's is being done at the dental
and eye institutes. Sjogren's syndrome crosses many specialties and
encompasses systemic manifestations, and because of that, we would like
to see NIAMS and NIAID become more actively involved in this disease.
We rely on the National Institutes of Health (NIH) to help educate
physicians and the public. Our foundation and the NIDCR co-hosted a
continuing education conference for healthcare providers this fall--the
first one ever at NIH. NIDCR held a scientific workshop at the same
time, and NIAMS published its first information booklet on Sjogren's
this year. These are wonderful, but these are only firsts. We MUST
continue and expand these initiatives.
We're seeing an explosion in medical and scientific opportunity
right now. We have incredible opportunities ranging from immunology to
cell biology, from drug development to genetic engineering, through
which genetic makeup might eventually be changed to actually block
autoimmune disease. The human genome project opens up new avenues for
discovering the genetic links in autoimmune disease. We have
unprecedented opportunities for research in the areas of
immunomodulation, gene therapy, and creation of artificial glands. We
MUST take advantage of this.
NATIONAL INSTITUTES OF HEALTH AND APPROPRIATIONS
Sjogren's syndrome is one of the most prevalent autoimmune
diseases. Yet, astonishingly, the prevalence does not match the low
dollar figure spent on research and education.
Sjogren's syndrome ranks ninth when we compare the number of
extramural grants at the National Institutes of Health (NIH) for
autoimmune disease. There are twice as many clinical trials for lupus,
another autoimmune disease, as are being done for Sjogren's syndrome,
but Sjogren's affects twice as many people.
The most recent figures available from the NIH Autoimmune Diseases
Coordinating Committee show that out of an approximately $18 billion
budget for NIH, $398 million was allocated for autoimmunity. Yet
autoimmunity is the third largest disease category in the U.S. Of the
total amount for autoimmunity, over 90 percent went to just three
autoimmune diseases--rheumatoid arthritis, juvenile diabetes, and
multiple sclerosis. Lupus received the next largest amount, leaving
about $45 million for 76 other autoimmune disorders, including
Sjogren's syndrome.
We ask your committee as it works on the next Appropriations bill,
to add the words ``Sjogren's syndrome'' any time another autoimmune
disease is mentioned by name. Sjogren's is one of the most prevalent
autoimmune diseases, is an ideal scientific model, and yet over and
over again it is left out.
We are working to change the visibility of and attention for
Sjogren's syndrome, and we hope after our testimony, you, as members of
the Subcommittee on Labor, Health and Human Services, Education and
Related Agencies, will recognize the importance of this disease.
We applaud you for supporting medical research at the NIH and
working towards doubling the NIH budget over 5 years. We applaud you
for your support and allocation of dollars for autoimmunity. We are
grateful for your support of the NIH Autoimmune Diseases Coordinating
Committee. Finally, we urge you to consider research costs not just in
dollars, but the human cost, the tremendous burden of disease on
families, and especially the specific burden of a prevalent and
devastating disease--Sjogren's syndrome.
HOW CAN THE SENATE APPROPRIATIONS SUBCOMMITTEE ON LABOR, HEALTH AND
HUMAN SERVICES, EDUCATION, AND RELATED AGENCIES HELP
A first and important step by Congress was establishing the
Autoimmune Diseases Coordinating Committee at the National Institutes
of Health. But we would like to see NIAMS and NIAID take on a larger
role in the many systemic aspects of this disease.
We ask that NIAMS and NIAID recognize that research in Sjogren's
syndrome is part of their mission and should be included in their
portfolio of grants.
______
Prepared Statement of the Sudden Infant Death Syndrome Alliance
Chairman Specter, thank you for the opportunity to address this
subcommittee and explain what Sudden Infant Death Syndrome and the
importance of federal funding for SIDS programs and research means to
me. My wife and I lost our son Chandler in 1997, and we are compelled
to do everything and anything possible to ensure no one has to suffer
the loss of a child again. Mr. Chairman, we need your help, your
commitment, and your support to help solve the mystery that is SIDS.
Despite the fact that SIDS cases have been documented for years,
organized scientific research into SIDS only began in the mid 1970's.
Three decades later scientists are now beginning to make significant
progress in unraveling the enigma of SIDS. For instance, we now know
that in many SIDS related deaths there is an abnormality in a region of
the brain which is thought to control heart and lung functions. In
these cases, this irregularity may have hampered normal respiratory
activity, and while not the sole cause of SIDS, it may have contributed
to a larger respiratory problem leading to death.
As a direct result of SIDS research and the ``Back to Sleep''
educational and awareness campaign, SIDS deaths have been reduced by 38
percent since 1992, concurrent with the increase in awareness regarding
infants being placed on their backs to sleep-leading to the greatest
decline in infant mortality rates in over 20 years.
However, our research and educational campaign is far from
finished. Each year more than 3,000 infants in the United States die
from SIDS and it continues to be the number one cause of death for
children between one month and one year of age. SIDS is a major
component of the United States infant mortality rate. In spite of this
fact, we do not yet understand the causes of SIDS nor do we possess a
guaranteed method for its prevention.
The primary federal agency responsible for conducting SIDS research
and the ``Back to Sleep'' public awareness campaign is the National
Institute of Child Health and Human Development (NICHD) at the National
Institutes of Health. In addition to federal funding of SIDS research,
there are other federal agencies involved in the SIDS effort. Since
1975, the Maternal and Child Health Bureau (MCHB) within the Health
Resources and Services Administration (HRSA) has supported specific
programs for SIDS family counseling and for public and professional
education about SIDS. The Centers for Disease Control and Prevention
(CDC) has established a standardized death scene investigation protocol
for SIDS incidents. Additionally an Interagency Panel on SIDS has been
established, which includes: NIH, HRSA, CDC, Indian Health Services,
Food and Drug Administration, U.S. Consumer Products Safety Commission,
Department of Defense, Administration for Children and Families, and
the Department of Justice to help coordinate all federally funded SIDS
activities.
The SIDS Alliance is grateful for the Subcommittee's past support
of SIDS activities, especially the support of NICHD. We urge you again
to provide the additional funding necessary for the second year of the
third Five Year SIDS Research Plan to ensure that NICHD can continue to
address critical SIDS research initiatives. Specifically the SIDS
Alliance is supporting a funding increase to $23.7 billion or 16.5
percent for NIH overall, and a 16.5 percent increase for NICHD to
$1.137 billion. We ask that the increases for NIH do not come at the
expense of other Public Health Service Agencies. Further research is
essential to find the reasons for, and means of preventing the tragedy
of SIDS.
I urge the Subcommittee to support SIDS educational, awareness, and
counseling activities that take place at the MCHB, and the death scene
investigation protocol demonstration projects at the CDC. These
programs are a vital ``flip-side'' to the good research that NICHD
does. Without prevention awareness, counseling, and standardized
investigation procedures, good research does not translate into
meaningful advances for SIDS victims and their families.
HIGHLIGHTS OF FEDERALLY FUNDED SIDS ACTIVITIES
National Institute of Child Health and Human Development (NICHD)
Childcare has become increasingly important in the social fabric of
the United States, so have child care centers and homes. To address
this issue the NICHD has initiated the ``Back to Sleep Child Care
Project,'' sending publications and other ``Back to Sleep'' materials
to over 280,000 child care centers and licensed homes throughout the
United States. Response to these mailings has been overwhelming,
resulting in a 20 percent increase in the volume of requests for Back
to Sleep materials.
Studies on the risk factors for SIDS among African American and
American Indian populations conducted in collaboration with the CDC and
the Indian Health Service have yielded valuable information for
targeted interventions to reduce infant mortality in these communities.
SIDS among minority populations continues to be a top priority for the
NICHD. Surveys show that the proportion of African Americans placing
their infants to sleep on their stomachs continues to decrease,
however, African Americans are still twice as likely to place infants
on their stomachs as compared to other populations. Discussion groups
are underway in African American communities across the country to
assess the ``Back to Sleep'' campaign message, and to improve message
delivery. In addition, during fiscal year 2001, the NICHD established
new initiatives on health disparities in minority populations. SIDS and
related fetal and infant deaths are part of the initiatives targeted at
eliminating health disparities in infant mortality.
A new component of the ``Back to Sleep'' campaign focusing on
reducing SIDS among African American was launched in late 1999. The
goal is to develop and implement a community-based initiative. The
National Black Child Development Institute (NBCDI) joined with the
NICHD, the campaign sponsors, and several other organizations in the
outreach initiative. A culturally appropriate resource kit, which
includes a training guide, has been developed, and the first national
training workshops have been held. Plans for fiscal year 2002 include
training at the local level through affiliate African American
organizations, and regional infant mortality summits. In addition,
discussions have begun for a community partnership campaign targeted to
reducing SIDS among American Indians in fiscal year 2002.
The mechanism of SIDS is still unknown; there are no clinical or
biologic tests to identify a newborn at high risk of succumbing to
SIDS; and more work is needed to increase the implementation of ``Back
to Sleep'' among all caregivers and in communities with high rates of
infant death. To address and focus its efforts on these challenges, the
NICHD is in the process of developing and implementing its third SIDS
Research Five-Year Plan. Meetings regarding various aspects of the
five-year plan have been held throughout the past two years and are
expected to continue. The plan will be divided into five parts:
Introduction, Etiology/Pathogenesis, Prognostics/Diagnostics,
Prevention, and Health Disparities. A draft of the Introduction and the
Etiology/Pathogenesis section will be open for public comment on the
web during the month of March 2001. The remainder of the draft plan
will be on the web for public comment in April.
Plans for research initiatives in fiscal year 2002 include (1)
continued research on mechanisms of pathogenesis through studies in
animal models, postmortem tissue, and high-risk infants. This includes
a prospective study to define a battery of physiologic and genetic
markers that will predict SIDS and to determine whether SIDS is part of
a larger family of autonomic nervous system disorders; (2) analysis of
epidemiological and physiological data collected during the second five
year research plan to improve our understanding of environmental and
intrinsic risk factors; (3) a community-linked health disparities
initiative to investigate related aspects of mortality from late fetal
life through early childhood; (4) improve risk reduction and efficacy
of ``Back to Sleep'' through continued research, monitoring, and
outreach in at risk communities.
Maternal and Child Health Bureau (MCHB)
The MCHB supports a number of SIDS and Other Infant Death related
services and programs, including the following activities:
--National SIDS Resource Center, a major source of current
information about SIDS.
--Maternal and Child Health Service Block Grant (MCH), which grants
funds to states providing a range of services to SIDS families.
Block grant funds support activities like: contact families
immediately after death, discussion of autopsy results with the
family, and support and counseling through the first year of
bereavement. Unfortunately, in many jurisdictions across the
country, funds for these services have been decreased or
eliminated due to budgetary difficulties.
--Field training and curriculum to health care providers for case
management of families who have experienced an infant death,
and the development of model programs, particularly for the
underserved and minorities. Demonstration grants have been
established in four states to target services for specific
populations: California, Massachusetts, Missouri, and New York.
--National SIDS & Infant Death Program Support Center to address SIDS
service issues at the federal level on an ongoing basis. The
SIDS Alliance was chosen to run this center, which opened in
1999, and has experienced notable success.
Centers for Disease Control and Prevention (CDC)
To develop a better statistical figure on SIDS cases, Congress
recommended in 1993 the establishment of a standard death scene
protocol to offset discrepancies on unexplained infant deaths between
states. It was hoped that this protocol would be adopted by states not
only for statistical measure, but to help avoid awkward and emotionally
charged misunderstandings at the death scene. In 1996, CDC published
the protocol, and since that time several states have adopted the
standard. It is SIDSA's long term goal to ensure that all states fully
adopt the protocol. To help realize this goal, SIDSA would like CDC to
heed Congress' recommendations for the past two years and implement
demonstration projects that follow these guidelines in several
communities nationwide. We would also encourage CDC to implement a
nationwide survey to measure how many locales have implemented the
protocol independently and to analyze the results thus far.
In conclusion, we are all too painfully aware that SIDS has
historically been a mystery, leaving in its wake devastated families
and bewildered physicians. Not only have there been no answers on the
cause of SIDS, but there have been no answers on how to effectively
prevent its occurrence. Today we are beginning to find some of the
answers on cause and prevention, and therefore reduce the risk of SIDS.
Because of the ``unknown'', however, babies are still vulnerable even
when parents and care givers take the cautionary steps to prevent SIDS
deaths. This tragedy will continue if research efforts are stalled or
halted, especially when we are at the point where so much progress has
been made. Now is the time for a re-energized effort against this
tragic syndrome.
On behalf of the thousands of families who have been devastated by
the loss of a baby to SIDS, and the millions of concerned and
frightened parents, we ask for your support, and thank you again for
allowing us to present this testimony. If you have any questions,
please do not hesitate to contact us.
______
Prepared Statement of the Trust for America's Health
Mr. Chairman, and members of the Committee, I wish to provide a
real perspective on our nation's ability to respond to health
emergencies like the pediatric leukemia cluster in Fallon, Nevada and
health concerns related to multiple sclerosis in Wellington, Ohio.
My name is Dr. Shelley Hearne and I serve as the executive director
of the Trust for America's Health--a new nonprofit health advocacy
organization taking action to prevent disease and protect the health
and safety of our communities. I am very proud to have former Governor
Lowell Weicker, Representative Louis Stokes, and Chairman John Porter
along with many other national leaders in public health serve on our
Advisory Council.
By way of background, I am an environmental health scientist--
serving for almost twenty years in government, non-profits, and as a
faculty member of the Johns Hopkins School of Public Health. Most
recently, I was the executive director of the Pew Environmental Health
Commission.
Let me be candid. Our public health service is falling short in its
duty to watch over the safety and health of Americans, particularly
when it comes to chronic diseases that may be associated with
environmental factors.
Chronic diseases such as cancer, asthma, Parkinson's, birth defects
and diabetes are responsible for 7 out of 10 deaths in this country.
More than a third of our population, over 100 million men, women and
children, suffer from chronic disease. By 2020, studies estimate that
chronic disease will strike 134 million Americans and cost $1 trillion
a year. And the Centers for Disease Control and Prevention (the
``CDC'') estimates that 70 percent are preventable.
Despite the human and financial toll of chronic diseases on our
country, we have no national approach to track these diseases and
respond effectively to cluster crises. Our federal, state, and local
agencies only coordinate tracking and responding to infectious diseases
such as polio, yellow fever and typhoid--diseases that a national
tracking and response system helped to eradicate back in the late
1800s.
Let me give you some examples of chronic disease clusters and
concerns from around the country and the problems we face in responding
to them.
In Fallon, Nevada, twelve children have been stricken with an acute
form of leukemia since 1997. This occurrence rate is higher than the
expected average of this disease in a town the size of Fallon.
Residents as well as health officials suspect that this cancer may be
linked to environmental factors such as a high level of naturally-
occurring arsenic in the water or possibly an infectious virus.
In my home state of New Jersey, between 1993-1997, parents in Brick
Township identified 53 cases of autism out of 6000 children between the
ages of 3 and 10 years. For years, parents complained to politicians
and health officials about a feared autism cluster in their community.
Health agencies are still trying to determine if this is a problem.
And in Wellington, Ohio, 25 citizens have been diagnosed with
multiple sclerosis (MS) in a town of 4,200. This rate is higher than
the national average based on recent studies. Residents worry about the
toxic exposures from a local iron foundry and the nearby landfill.
In each case, our public health officials lacked the disease
occurrence data, personnel, training, and lab capacity to detect these
health emergencies and respond to them.
Many chronic diseases are preventable, and each of the above
mentioned clusters and health concerns might have been a preventable
tragedy. But, because we have no coordinated national tracking of
chronic disease, we are unable to identify disease clusters and respond
quickly to these health emergencies. As a result, we are hamstringing
our scientists from finding solutions and effectively taking action--
regardless if it's childhood leukemia in Fallon or multiple sclerosis
in Ohio.
Let me describe the existing status of our fractured state health
tracking networks.
--Even though studies have shown that birth defects are the number
one cause of infant mortality, 17 states do not track birth
defects--Pennsylvania, Ohio, Mississippi, New Hampshire,
Louisiana, Vermont, Rhode Island, Indiana, Minnesota, South
Dakota, North Dakota, Wyoming, Montana, Idaho, Nevada, Oregon,
and Washington.
--Only eight states and the District of Columbia track developmental
diseases such as cerebral palsy, autism and mental retardation
even though the National Academy of Science estimates that 25
percent of these diseases in children are caused by
environmental factors--California, Kentucky, Mississippi,
Nebraska, New Jersey, North Carolina, South Carolina, and South
Dakota.
--Even though studies have shown autoimmune diseases like Lupus to be
increasing, only four states report tracking this disease--
Arizona, Massachusetts, New Mexico, and South Dakota.
--For years most states did not track cancer. Tracking began in the
early 1990's when the CDC allocated money to the states to
start cancer registries. Uniform standards for the state cancer
tracking networks were just established in 1997.
--More than half of the states do not track asthma even though
studies have shown that asthma attacks are the number one cause
of school absenteeism and that asthma has increased 75 percent
between 1980 and 1994.
The Pew Environmental Health Commission based out of the Johns
Hopkins School of Public Health studied ways to strengthen our nation's
public health defenses and proposed creating a Nationwide Health
Tracking Network.
The Nationwide Health Tracking Network consists of five components:
Coordinating essential data collection systems.--The first
component builds on existing health and environmental data collection
systems and establishes data collection systems where they do not
exist. The Network would coordinate with the local, state and federal
health agencies to collect this critical data.
In all fifty states, the Network would track:
--Asthma and other respiratory diseases;
--Developmental diseases such as autism, cerebral palsy, and mental
retardation;
--Neurological diseases such as Alzheimer's, multiple sclerosis, and
Parkinson's;
--Birth defects; and
--Cancers, especially in children.
The Network also would track exposures to:
--Heavy metals such as mercury and lead;
--Pesticides such as organophosphates and carbamates;
--Air contaminants such as toluene and carbamates;
--Organic compounds such as PCB's and dioxins; and
--Drinking water contaminants, including pathogens.
Developing an Early Warning System.--The second component is an
Early Warning System that would immediately alert communities to health
emergencies such as lead, pesticide and mercury poisonings. The
existing system of local health officials, hospitals and poison centers
that alert our communities to outbreaks like food illness and the West
Nile virus would also warn our communities about these health
emergencies.
Creating Rapid Response Teams.--The third component consists of
improving our response time to identified disease clusters and other
health emergencies. The Network would coordinate federal, state and
local health officials into Rapid Response Teams to quickly investigate
these health emergencies, providing the teams with the trained
personnel and necessary equipment.
Addressing unique local health problems.--The fourth component is a
pilot program consisting of twenty regional programs that would
investigate local disease clusters and emergencies outside of the
Network. These programs would alert the public and health officials to
new developing disease clusters. These pilots programs also would serve
as possible tracking models to be included in the Network.
Creating community and academic partnerships.--The fifth component
creates relationships with our communities and with regional academic
centers. Community relationships would ensure that the tracking data is
accessible and useful on a local level. The academic partners would
assist with training the workforce, analyzing data, and developing
links between the tracking results and preventative measures.
[The background and basis for this Network and other Commission
findings are also available on the website at http://
healthyamericans.org or http://health-track.org]
This Network would provide our communities, scientists, doctors,
hospitals and public health officials with the missing data on where
chronic diseases are occurring and whom they are striking. This basic,
but yet critical, information would enable us to develop effective
prevention strategies to protect the health of our citizens.
Data from the Network will also allow us to spend our limited
research dollars more effectively by identifying which chronic diseases
are increasing and where they are clustering. We have doubled our
research dollars in the National Institutes of Health, yet these
scientists do not have the most basic information about how often and
where chronic disease occurs. Without a Network, our scientists will
remain in the dark, unable to develop effective prevention strategies.
Developing prevention strategies for chronic diseases is critical
to reducing the $325 billion our country spends on these diseases. In
less than fifteen years, the cost of chronic disease is expected to
rise to $1 trillion. The estimated cost of the Network is about $275
million or less than 1 dollar per every man, woman and child. This is
the most cost effective use of tax dollars today--investing in ways to
prevent the leading and most costly diseases in this country.
The public strongly supports the concept of nationwide tracking. A
recent public opinion poll by Princeton Survey Research Associates
revealed that nine out of ten (89 percent) registered voters support
the creation of a national health tracking system. The American public
is so concerned about this issue that 63 percent feel that public
health spending is more important than cutting taxes. Seven out of ten
registered voters (73 percent) feel that public health spending is more
important than spending on a national missile defense system.
Over thirty key health organizations have endorsed the Network,
ranging from Aetna US Health Care to the American Heart Association to
the Association of State and Territorial Health Officers.
The American Chemistry Council supports the concept, noting ``. . .
data generated by a national tracking program can shift the focus from
debate and speculation about disease trends to intervention and
prevention based on scientific evidence.''
Most local health departments face declining funding, inadequate
training for staff, limited or no laboratory access, and outdated
information systems. The CDC, the Agency for Toxic Substances and
Disease Registry (the ``ATSDR'') and other federal agencies have not
been able to adequately help our local health departments. For
instance, most states do not have a chronic disease investigator.
Recently in Fallon Nevada neither the CDC nor the ATSDR could give
Nevada written guidance, standards or protocols on how to investigate
their childhood cancer cluster. Our federal health agencies have never
developed a concrete response program to these growing disease cluster
demands.
We are concerned that the Administration's proposed budget
recommends severe cuts for the nation's chronic disease prevention
programs. Overall, the Administration is recommending $109,000,000 cut
from last years budget for the CDC, most of it coming from the National
Center for Chronic Disease Prevention and Health Promotion. We need to
be going in the exact opposite direction. Health defense should be the
country's number one commitment.
In order for us to identify clusters before they grow, we must take
rapid action. The CDC must be given the direct mandate to aggressively
respond to communities' concerns like those in Fallon and Wellington
with modern tools and health tracking. And Congress must prioritize
$275 million per year--just a tenth of one percent of the overall
spending of health care dollars in this country.
Without this type of investment, we will only watch asthma, certain
cancers and other chronic disease rates continue to raise. There will
be many more Fallons. And that will be the greatest tragedy of all.
______
Prepared Statement of the United Fresh Fruit & Vegetable Association
United Fresh Fruit & Vegetable Association appreciates the
opportunity to testify in strong support of increased funding for
nutrition, physical activity, and obesity at the Centers for Disease
Control and Prevention (CDC). As the national trade organization
representing the views of producers, wholesalers, distributors, brokers
and processors of fresh fruits and vegetables, United has worked
aggressively for many years to enhance federal programs and policies to
address the staggering costs associated with poor diets and physical
inactivity.
According to the U.S. Department of Health & Human Services (HHS),
unhealthy eating habits and physical inactivity are now the nation's
second leading actual cause of death and are primary factors in the
skyrocketing rates of obesity and number of overweight persons.
Unhealthy eating and physical inactivity are also major causes of heart
disease, cancer, stroke, diabetes, high blood pressure, and
osteoporosis. In fact, HHS estimates that unhealthy eating and
inactivity contribute to between 310,000 and 580,000 deaths each year,
13 times more than gun-related deaths and 20 times higher than deaths
due to illicit drug use.
The costs of diseases caused by unhealthy diets and physical
inactivity are enormous. Annual costs related to cancer, coronary heart
disease, obesity, diabetes, stroke and osteoporosis now total nearly
$550 billion. For Medicare patients alone, the Health Care Financing
Administration (HCFA) estimates that coronary heart disease costs
taxpayers $9.8 billion per year and strokes cost an additional $3.7
billion. Furthermore, when assessing the costs of diet related diseases
only, the U.S. Department of Agriculture (USDA) has estimated that
healthier diets could prevent at least $71 billion per year in medical
costs, lost productivity, and lost lives. It is important to note that
this estimate only takes into account diet-related coronary heart
disease, stroke, cancer and diabetes and not other diet-related
diseases.
It is obvious that the challenges faced by today's healthcare
delivery system have changed enormously, and over the past century, the
leading causes of death have shifted from infectious to chronic
diseases. These diseases are expensive to treat; and many of them
cannot be cured so they require years of expensive treatments.
The CDC has stated that of the 30-year increase in life expectancy
between 1900 and 1999, only five years can be attributed to curative
medicine, and the remaining 25 years of the increase represent advances
in public health and preventive measures. However, today's health care
system is still geared almost exclusively toward treatment of disease.
Despite the proven success of preventive medicine, spending by state
and federal governments averaged $1,390 per person per year for disease
treatment and only $1.21 per person per year for preventive measures.
We are not advocating that these numbers should be reversed. We are,
however, recommending that the United States begin to make sound
investments in preventive measures for the well-being of all Americans.
A modest investment in programs that can change diet and activity
patterns can prevent enormous long-term spending on treatment in the
future.
Leading health experts have asserted their firm belief in the
benefits of a nutritious diet and physical activity. The National
Academy of Sciences (NAS), CDC, USDA, Surgeon General, and others have
affirmed that Americans must change their diets and become more
physically active if the rates of illness and premature death are to be
reduced.
With research documenting health benefits of increased fruit and
vegetable consumption and increased exercise to reduce the risk of
cancer and numerous other serious illnesses including heart disease,
stroke, obesity and high blood pressure, we support aggressive action
to further these important health messages. For example, studies show
that people who eat five or more servings of fruits and vegetables each
day have one-half the cancer risk of those who eat fewer than two
servings. In the area of physical activity, it is documented that a
regimen of at least 30-45 minutes of brisk walking, bicycling, or even
working around the house or yard will further reduce risks of chronic
illness including coronary heart disease, hypertension, colon cancer,
and diabetes.
However, only one in four Americans consume five or more servings
of fruits and vegetables per day and children ages six to 12 are eating
only two-and-a-half servings of fruits and vegetables a day, half of
the minimum amount recommended by national guidelines. In the area of
physical activity, research indicates that 60 percent--well over half
of Americans are not regularly active. Worse yet, 25 percent of
Americans are not active at all. With such statistics and limited
funding available for federal campaigns to change these behaviors, poor
diets, physical inactivity and obesity will soon be the number one
cause of preventable deaths and avoidable health care costs.
Current trends document this assumption with at least one-third of
all cancer, 20-to-40 percent of heart attack and stroke, and as much as
80 percent of Type 2 diabetes being diet-related, and the diet- and
exercise-attributable costs of these four conditions nationally are
comparable to tobacco. Additionally, obesity which is a primary marker
of poor eating and exercise habits, has been declared an epidemic by
CDC. This country desperately needs to attack the problem of poor diet
and physical inactivity with an initiative of similar scope and
duration to that mounted against tobacco over the last decade. The
longer we wait to start, the harder it will be to reverse, and the more
we will pay as health care becomes more expensive.
To reverse these dangerous trends and begin to elevate this issue
at the federal level, United Fresh Fruit & Vegetable Association
supports multi-year appropriations totaling $350 million for CDC to
expand and build upon ongoing national and state intervention
initiatives within the Division of Nutrition and Physical Activity.
This funding level will allow CDC to implement a national coordinated
nutrition and physical activity plan in every state and a corresponding
national media education strategy. Only through such aggressive funding
increases will CDC in coordination with state departments of health be
able to put in place a national strategy that encourages healthy eating
and increased physical activity that is supported by coordinated
communications efforts at the federal level. Presently, nutrition and
physical activity are the only major chronic disease risk factors
without dedicated funding for state intervention programs. While some
states do have programs in place for obesity prevention, nutrition and
physical activity, these efforts will remain very limited and
ineffective without substantial federal funding. The expertise of the
CDC in the implementation of effective intervention strategies, health
communications, education, and prevention research will enhance the
success of state-based efforts by providing states with additional
federal resources to leverage their efforts and ensure the
implementation of best practices.
We are well aware of budget constraints facing the Committee.
However, we strongly encourage the Committee to carefully examine the
need to take aggressive action to implement a national coordinated
nutrition and physical activity strategy to address the staggering
costs of chronic diseases. When you look at the costs associated with
heart disease, cancer, diabetes, stroke, high blood pressure, and
osteoporosis which total $405 billion a year, we think that $350
million is a very small investment to make in the future health of our
nation.
We look forward to working with the Committee on this critical
issue and hope that this request can be accommodated to the maximum
extent possible during the coming fiscal year. Thank you for your time
and consideration.
______
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, freestanding health sciences university in the
nation. Our statewide system is located on five academic campuses and
consists of eight schools (3 medical, a dental, nursing, public health,
health related professions and a graduate school of 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 across the
state. No other institution in the nation possesses the resources that
match our scope in higher education, research, health care delivery,
and community service initiatives with federal, state and local
government entities.
The University's priority projects are statewide in scope and
include collaborations both within the University system and with our
academic and health care partners. Our mission is focused on building
``Centers of Excellence'' that will expand our research, enhance our
educational programs and provide access to quality health care services
for all New Jerseyans. Our projects also underscore UMDNJ's commitment
to eliminating racial disparities in health care delivery, which is why
our first priority initiative is the Institute for the Elimination of
Health Disparities.
The Federal Government has identified striking disparities in the
overall health and life expectancy of racial and ethnic populations in
the United States. Despite dramatic improvements in health care,
disparities still exist among racial and ethnic groups. In recognition
of the importance of health disparities to the health of all citizens,
UMDNJ supports the efforts of the federal government in a number of
initiatives aimed at eliminating health disparities.
UMDNJ has long been recognized for its leadership in providing
educational opportunities and health care services to under-represented
communities throughout our state. We are a leader in minority student
education, minority faculty recruitment and patient care services to
minority populations through our core and affiliated hospitals, clinics
and community-based programs.
UMDNJ is developing an Institute for the Elimination of Health
Disparities that will have statewide impact. The mission of the
Institute is to eliminate health disparities through training minority
health care providers, improving research on minority health,
increasing the number of minority scientists and improving outcomes in
health service delivery to minority populations.
The Institute is based in Newark, the largest city in New Jersey
with a diverse population, socio-economic status and special health
care needs. Newark is also home to UMDNJ-University Hospital, a Level I
Trauma Center and the state's only public safety net hospital serving
the largest number of indigent patients. In addition to Newark, the
Institute will provide services in our host communities of Camden and
New Brunswick, which also have large diverse populations.
Leadership of the Institute is provided by the UMDNJ-School of
Public Health in partnership with all schools of the University and
with our Centers of Excellence including the Cancer Institute of New
Jersey; the Environmental and Occupational Health Sciences Institute;
the National Pediatric & Family HIV Resource Center; the Hispanic
Center of Excellence, the Minority Oral Health Research Center; the
Chandler Health Center (a Federally Qualified Health Center); and the
Center for Healthy Families and Cultural Diversity. The Institute will
also collaborate with state, county, city, community and private
organizations to extend its visibility and outreach.
The Federal Government has identified six broad areas that
disproportionately affect racial and ethnic populations including
infant mortality, cancer, cardiovascular disease, diabetes, HIV/AIDS
and childhood immunization. The Institute will focus its research,
training and education programs on initiatives related to these areas,
and will work to implement other programs that will improve overall
health outcomes.
UMDNJ is ideally positioned to lead New Jersey's efforts to
eliminate racial and ethnic health disparities. We are requesting $5
million over 5 years to carry out the mission of the Institute for the
Elimination of Health Disparities on behalf of the citizens of New
Jersey and the nation.
Our second priority is the Cancer Institute of New Jersey.
The Cancer Institute of New Jersey was established in 1990 with a
$10 million capital grant from the federal government. Over the past
decade, CINJ has grown to become one of the nation's most successful
cancer institutes and New Jersey's only NCI-designated clinical cancer
center. New Jersey has been especially devastated by cancer where
incidence and mortality rates are high compared to national averages.
Since it opened its doors, CINJ is successfully fulfilling its mission
through innovative advances in research and patient care. CINJ's basic
and clinical research are conducted in collaboration with its clinical
partners and other academic institutions, community physicians and
health care professionals. CINJ's provider network of 20 hospitals
stretches across the state and services reach people in every county in
New Jersey.
CANCER INSTITUTE OF NEW JERSEY
One of CINJ's significant accomplishments is the creation of the
Dean and Betty Gallo Prostate Cancer Center established with funding
from the federal government. The Center honors the late Congressman
Dean Gallo, who succumbed to prostate cancer in 1994. The Gallo
Prostate Cancer Center has garnered $9 million in federal
appropriations over the past 3 years and is the state's only
specialized prostate health resource located at an NCI-designated
cancer center.
Because African-American males are 2.5 times more likely to die
from prostate cancer than white males, the Gallo Prostate Cancer Center
has partnered with the 100 Black Men of New Jersey organization to
offer prostate cancer screenings in minority communities throughout the
state. A major goal of the Gallo Prostate Cancer Center is to expand
its educational awareness and health screenings to every county in New
Jersey.
Additional resources are needed to accelerate the Gallo Center's
promising research and to expand its services to the community through
education and prevention programs. This expansion is hindered by a
critical lack of space in CINJ's New Brunswick facility. Constructed in
1996 to accommodate 16,000 patient visits, CINJ is now seeing 37,000
patients per year with more than 3,000 new patients seeking care. Based
on this rate of growth, CINJ anticipates between 50,000 to 60,000
patient visits per year and 5,000 new patients by the year 2003.
UMDNJ has responded to this need for additional space by approving
the construction of a 120,000 square foot addition to CINJ's New
Brunswick facility. This new space will house the Gallo Prostate Cancer
Center as well as provide more space for the treatment of other types
of cancer, research, teaching and support staff. We have commitments of
$16 million toward the construction cost of approximately $30 million
and request $10 million in federal participation to expand the Cancer
Institute of New Jersey facility to house the Gallo Prostate Cancer
Center.
Another priority initiative is the Child Health Institute of New
Jersey.
The UMDNJ-Robert Wood Johnson Medical School has developed the
Child Health Institute of New Jersey as a comprehensive biomedical
research center focused on the health and wellness of children. The
Child Health Institute (CHI) has garnered close to $5 million in
federal funds over the past two years and has been awarded a $1.9
million facility grant from the National Center for Research Resources
of the NIH in fiscal year 2000. The CHI has received $27 million from
private foundations, corporations and individuals, as well as from the
state and federal government, to construct a 100,000 square foot
research facility in New Brunswick, NJ. The CHI will grow the current
research funding base of the Robert Wood Johnson Medical School and
strengthen research efforts with clinical departments at the Robert
Wood Johnson University Hospital, especially those involved with the
new Children's Hospital.
The Child Health Institute will focus research on molecular
genetics that direct development of human growth and function. Research
will serve as the basis for new treatments, therapies and cures for
devastating and debilitating childhood syndromes. Scientists will
direct efforts toward the environmental, genetic and cellular causes of
diseases in infants and children in a quest to prevent, treat and cure
these diseases. Some of the disorders that warrant immediate attention
include asthma, muscular dystrophy, diabetes, birth defects and neuro-
developmental disorders including autism and spina bifida.
Currently, the Child Health Institute serves as the hub for the New
Jersey Governor's Council on Autism at UMDNJ. The Council distributes
grants from the State to improve the treatment of autistic children, to
educate families and physicians and to investigate causes and possible
cures for autism. The Child Health Institute represents the best hope
for a sustained campaign against childhood diseases and disorders and
provides a unique opportunity to support the health and welfare of this
generation and to protect the health of future generations.
Basic science is the key to the future of medicine. As scientists
unravel the human genetic code, the impact on America's health is
enormous. We are at the brink of discovering which genes cause birth
defects and the root causes for disease so that prevention and cures
can be realized.
The Child Health Institute has the expertise and the infrastructure
in place to achieve major breakthroughs and discoveries that will lead
to improvements and cures in childhood diseases.
We request $5 million in federal participation to cap the
development of the Child Health Institute of New Jersey.
UMDNJ is committed to scientific research that will benefit the
elderly as well as children. That is why our next priority is the
Geriatric Research Center.
The Center for Aging at the UMDNJ-School of Osteopathic Medicine
(SOM) is an inter-disciplinary center of excellence in geriatric
education, clinical care and research. The Center is nationally
recognized as a leader in quality care for older individuals through an
array of services in the field of aging. Attracting more researchers to
the Center is critical to achieving national prominence as a Geriatric
Research Center of Excellence. The research programs of the Center will
focus on the cellular, biochemical and physiological basis of aging.
Research will be directed at the genetic determinants of both aging and
diseases common in the elderly. The Research Center will build on
existing programs in nutrition, protein loss, injury, Alzheimer's
disease to expand basic science research programs in support of the
established clinical and educational programs at the Center for Aging.
A major drawback is the critical lack of dedicated research space to
expand the Center's research laboratories. We seek $5 million in
capital and program funds to support dedicated space for the Geriatric
Research Center at the Center for Aging at SOM.
Our final priority is to implement a statewide medical response
system to respond to catastrophic emergencies as an integral component
of the UMDNJ-Center for BioDefense in New Jersey.
UMDNJ has established a Center for BioDefense which achieved $3
million in federal funding over the past two years. That funding is
focused on scientific research to understand and identify infectious
biological organisms in order to develop treatments for victims of
bioterrorist attacks.
New Jersey is the most densely populated state in the nation with
more than 8 million residents. New Jersey is home to a myriad of high
technology companies and the national headquarters of leading-edge
pharmaceutical, radiological and chemical industries. As such, New
Jersey is a prime target for terrorist attacks which employ weapons of
mass destruction including biological and chemical attacks. Successful
mitigation of these events requires a proactive, coordinated effort in
planning, training, monitoring and response.
A significant component of the UMDNJ-Center for BioDefense is our
expertise in education and training concerning chemical and biological
weapons. While emergency medical technicians and paramedics maintain
state certification requirements, this does not include continued
education in incident command, EMS mass casualty response training, and
hazardous material training.
The UMDNJ Center for BioDefense will use the expertise at UMDNJ-
University Hospital, the state's Level I Trauma Center, and University
Emergency Medical Services (EMS) to provide statewide leadership in
training of EMS, first responders and other health professionals and to
coordinate a standard regional response to incidents involving weapons
of mass destruction, bioterrorism or public health threats. The
Incident Support and Operational Planning (ISOP) team will be
responsible for training, coordinated communications and response. The
unit would also provide technical expertise to assist communities in
the development of emergency plans and procedures.
The team will track and disseminate statewide hospital bed status
through technology at University Hospital's Regional Emergency Medical
Communications System dispatch center. Improvements to the system would
include implementing a secure internet-based tracking system, upgrading
the existing radio system to integrate with the New Jersey State
Police, the Office of Emergency Management, and the Departments of
Health and Transportation, as well as implementing an alert network to
provide public health agencies with information on potential public
health threats. We request funding of $2 million for the Center of
BioDefense to assist our efforts to develop a statewide Medical
Response System that will strengthen New Jersey's ability to respond to
bioterrorism.
Thank you again for your past support and for the opportunity to
present testimony of the University of Medicine and Dentistry of New
Jersey (UMDNJ) on its priority initiatives in cancer, children's
health, geriatrics, biodefense and the elimination of racial and ethnic
health disparities.
______
Prepared Statement of Dr. William H. Lippy
I would like to express my support for increased funding of
Universal Newborn Hearing Screening (UNHS) programs through the Health
Resources and Services Administration (HRSA) and the Centers for
Disease Control (CDC). President Bush's proposed budget for fiscal year
2002 cut appropriations for these programs, despite the fact that
deafness is the most common birth defect in the United States.
Each year 12,000 babies--one in 300--are born with some type of
hearing impairment. Technologies such as hearing aids and cochlear
implants can alleviate the symptoms of deafness, although these
interventions must be made within the first 24 months of life in order
to ensure full learning capabilities and language development.
Currently, only 32 states have enacted some type of newborn
screening legislation and less than half of all infants are screened
for hearing impairment at birth. As a result, deafness is not
identified in children until age 30 months, on average, in the United
States. Special education costs an additional $420,000 per deaf child
by high school graduation, and the combined expenses of deaf education
and lost productivity result in average lifetime costs of over $1
million per deaf individual. Newborn hearing screenings average $15-50
in price.
In fiscal year 2001, $8 million was appropriated to HRSA for UNHS,
and approximately $6 million was appropriated to CDC. In order to
sustain the grants of those states that already receive funding and
increase the number of participating states, however, $10 million must
be appropriated to both HRSA and CDC specifically for UNHS in fiscal
year 2002.
I appreciate your attention to this critical issue and request a
response to my inquiry.
______
Prepared Statement of the University of Miami, Coral Gables, Florida
Mr. Chairman and Members of the Subcommittee: I appreciate the
opportunity to appear before you today on behalf of my colleagues at
the University of Miami School of Medicine.
The University of Miami, a private university founded in 1925, has
grown to become a major research and educational institution with
strong collaborations and affiliations nationally and internationally.
The University consists of 14 schools and colleges with 2,341 faculty
and 13,715 undergraduate and graduate students, with facilities located
on five campuses. According to the latest National Science Foundation
survey, ``Federally Funded Research and Development Expenditures,'' the
University ranks 40th nationally and 18th of all private universities
with medical schools. Annual expenditures in support of sponsored
programs exceeded $194 million during the fiscal year ending May 31,
2000.
The School of Medicine was established in 1952, and was the first
accredited medical school in the State of Florida. It has over 1,000
faculty members as well as a large research, administrative, and
support staff. In addition to 619 students enrolled for the M.D.
degree, the School of Medicine offers a variety of graduate programs
with over 350 enrolled students. With its community partner, Jackson
Memorial Hospital, it comprises the second largest medical center in
the United States and is recognized for its excellence in research,
teaching, and community service. The University of Miami/Jackson
Memorial Medical Center complex occupies 67 acres and combines
facilities in three hospitals, an affiliated Veterans Administration
Hospital, the Diabetes Research Institute, the Sylvester Comprehensive
Cancer Center, the Bascom Palmer Eye Institute, and numerous other
facilities. Sponsored program expenditures during the past fiscal year
exceeded $142 million. NIH statistics for fiscal year 1999 rank the
School of Medicine as 42nd among the 123 medical schools receiving
funding, with over $59 million committed to our programs. There is an
additional $5 million in annual NIH funding at our other campuses. U.S.
physicians rank our teaching hospital in the top 10 percent of all
teaching hospitals in the nation.
One of the major objectives of the School of Medicine's research
programs is to promote interdisciplinary collaboration and
translational research. Basic scientists and clinicians interact
regularly through structured programs and disease-oriented conferences.
These have resulted in innovative research and, more importantly, the
translation of our basic laboratory findings to the clinical setting.
The University has invested its own funds in numerous projects and
facilities dedicated to advancing this objective.
In this regard, the University of Miami respectfully requests the
Subcommittee to allocate funding that assists in understanding the
incidence and causes of disease among particularly vulnerable
populations--children, women, the elderly and ethnic minorities, and
especially among African-American, Hispanic, and Native American
populations.
HIV/AIDS
Miami and the surrounding South Florida region continue to show
strong population growth with an unparalleled ethnic diversity. The
incidence of HIV and HTLV infections among this population group is
high and requires continuous health support. In turn, this patient
population offers a unique opportunity and challenge for the
understanding of disease pathogenesis caused by HIV/HTLV, including the
progression to neoplasia and immunodeficiency.
Investigators at the University of Miami School of Medicine have
played important roles in helping to understand and resolve the HIV/
AIDS crisis locally, nationally and internationally. In addition to
studies in the United States, we have collaborative HIV programs in the
Dominican Republic, Zambia, China, and India. Examples of significant
seminal research studies conducted at the University of Miami produced
the following findings: AZT protection of newborns from maternal/fetal
transmission of HIV; transmission of HIV through sharing of needles by
drug abusers, discovered here, led to initiatives in interrupting this
route of transmission; and the effectiveness of the combination of Ifn-
a with AZT for the treatment of AIDS related lymphomas was elucidated
here recently.
The strong clinical, epidemiological and behavioral research
programs at the University continue to attract a high level of
competitive funding from the NIH, as evidence of their vitality and
strength. However, it has become clear in the research community that
further progress in limiting HIV/HTLV morbidity and mortality requires
a broader understanding of HIV/HTLV pathogenesis. It is evident that
the changes during disease onset and progression, both in the virus and
in the immune system of the host, are complex and far from understood.
It also is clear that a deeper insight into the virus-host relationship
is the only way by which further progress can be made. Some
institutions have significant NIH funding for HIV/AIDS research in
clinical trials and epidemiological studies; however, with modest
funded laboratory research programs.
We ask that the Committee provide resources to support programs
through the Health Resources and Services Administration that allow for
the enhancement of facilities and equipment that bolster HIV/AIDS basic
research and treatment facilities and equipment especially for
children, and particularly in entities with recognized excellent
epidemiological and clinical programs.
MINORITY RESPIRATORY DISEASE RESEARCH
Vulnerable populations in the United States, especially those
located in major metropolitan areas, are experiencing a much higher and
more severe level of respiratory disease. Diseases such as asthma, and
smoking related diseases such as lung cancer and emphysema, are rising
at unprecedented rates. To address these critical issues, unique
partnerships that bring together existing national research assets that
can focus on developing new treatments and preventative strategies
designed to have the maximum impact on vulnerable groups, which include
children, women, the elderly and African-American, Hispanic, and Native
American populations.
Respiratory diseases including asthma, chronic bronchitis,
emphysema, and lung cancer are a growing problem in the United States
and worldwide. While mortality from most chronic diseases such as heart
disease and cancer has substantially declined over the last few
decades, deaths from respiratory diseases have increased and are
projected to continue to increase over the next decade. Although many
respiratory diseases are attributable to smoking, asthma, which most
commonly afflicts young non-smokers, has also had a remarkable increase
in incidence and mortality. Respiratory diseases occur most commonly
among children and the elderly, and also tend to have the most impact
on these vulnerable populations. Population-based surveys have
suggested that most of the increase in respiratory disease has occurred
among minority populations and children. Also, at equivalent levels of
environmental exposure, women are more susceptible to developing
respiratory disease than men.
It is not clear why there has been an increase in respiratory
disease. Most respiratory diseases are the consequence of complex
interactions between environmental exposures and individual
susceptibility factors. The pathway from environmental exposure to the
diagnosis of respiratory disease may be affected by multiple factors at
every step that confound or modify the exposure-disease relationship.
The complexity of this system makes it difficult to identify causal
relationships or to interpret the significance of these relationships
when they are found.
For example, several studies have suggested that exposures that
result from crowded inner-city conditions could be responsible for the
increased incidence of asthma in African-American children; however,
others have suggested that a lack of exposure to common environmental
pathogens could result in the immune system hyper-reactivity that
characterizes asthma. However, without a complete understanding and
inventory of environmental exposures, it is impossible to know what
contribution inheritance has had to the increased incidence of disease,
or how potential new therapies targeted at immune-system defects will
help.
Without a multidisciplinary approach, it is unlikely that
researchers ever will be able to identify the true causes of this
increase in respiratory illness, much less design effective solutions.
To conquer this problem, it is essential that the resources and talents
of scientists from a broad spectrum of disciplines work cooperatively,
and that the mechanisms of respiratory disease in a variety of regions
and ethnic groups be carefully examined.
We urge the Committee to support initiatives through the CDC and
Public Health Emergency Fund that will advance long-term organized
community-based health utilization studies, especially those that
examine the growing incidence of respiratory disease among minority
populations. State-of-the-art collaborations with recognized partners
that have traditional affiliations with minority populations and that
will allow the use of innovative research techniques will help
elucidate the significance of specific causative factors across
different populations in the affected communities, and beyond.
THE ELDERLY AND ELDER ABUSE
Demographic reports unequivocally document the fact that the
fastest growing segment of the U.S. population is those over the age of
65 years, especially the ``elderly'' elderly, over the age of 80 years.
Florida is in the unique position of having the fastest growing elderly
population, and South Florida, in particular, of having to deal with
the cultural diversity of that population. With the increasing
probability of longer life spans, come increasing problems related to
chronic diseases and fewer social and economic resources. Elderly
individuals are particularly vulnerable and require more medical,
legal, and social interventions as well as greater dependence on family
caregiving where possible. In response to the needs of older Americans
the necessity to develop extensive and integrated services is critical.
These services range from assessments of competency and functional
capacity and guardianship, to the end of life decision making, to long
term care issues, elder abuse, to resource allocation and the economic
impact on the aging population and their families.
Though not all encompassing, the importance of education and
research in this arena will have significant impact on shaping public
policies and on practical approaches to assist the medical and legal
fields, including law enforcement, the judiciary, and policy makers.
We urge the Committee to provide funding through the Administration
on Aging and the Health Care Financing Administration for programs and
projects that address the specific issues of importance to the aging
population, including: abuse and neglect, management models for unique
care requirements, a focus on the role of families and caregivers, end-
of-life care, mental capacity, and research ethics. We would envision
programs and projects that would involve collaborations between
university schools of medicine and law and clinicians and researchers
in related university departments and in community agencies.
Mr. Chairman, we understand how difficult a year this will be for
you and the Subcommittee. However, my colleagues and I at the
University of Miami respectfully request that you give serious
consideration to providing support for initiatives that assist in
understanding the incidence and causes of disease among particularly
vulnerable populations--children, women, the elderly, and ethnic
minorities, and especially among African-American, Hispanic, and Native
American populations. Vital initiatives in these areas all have great
implications and will provide exceptional benefits to the well being of
the nation.
Thank you for allowing me to appear here today.
______
RELATED AGENCIES/GENERAL TESTIMONY
Prepared Statement of the American Library Association
The American Library Association appreciates the opportunity to
present testimony for the record in support of appropriations for
library programs through the Library Services and Technology Act,
administered by the Institute of Museum and Library Services.
We thank the Subcommittee and you as Chairman for your strong
support for libraries in the past and ask for that support again for
appropriations for fiscal year 2002.
All Americans benefit from the small, but critical, Federal role
that assists libraries to foster an informed citizenry in the service
of democracy. Federal support for libraries is concentrated on two key
national goals: outreach to those for whom library service requires
extra effort or special materials, (such as individuals with
disabilities); and, mechanisms to identify, preserve and share library
and information resources across institutional or governmental
boundaries through technology. The Federal role has traditionally
focused on areas which require incentive funding for activities that
libraries have difficulty initiating independently, which involve
coordinated interstate and intrastate efforts, or which benefit from a
national policy initiative.
The library community is capable of astonishing creativity and
expertise in support of national goals such as revitalizing the
economy, having children start school ready to learn, and developing
literate, informed adults. Oftentimes, one of the few sources of
funding for innovation available to libraries is Federal funding. It is
estimated that library programs generate some $3 to $4 dollars for
every Federal dollar invested.
President Bush has said on many occasions in discussing his new
education proposals that ``we must leave no child behind.'' America's
libraries believe that we can also afford to leave no reader behind.
That statement also includes pre-readers such as very young children,
those learning to read, young adult and adult learners. That is why we
feel so strongly that library programs need additional Federal funding.
Within the overarching theme of ``Leaving No Reader Behind,'' our
specific recommendations for fiscal year 2002 are guided by three basic
priorities, I am sure you share our vision that:
--We need to ensure equitable access and participation of our
nation's readers to library activities and opportunities in
their communities. Gaps in access exist not only in rural
areas, but also in cities that lack an advanced
telecommunications infrastructure.
--We need to support our libraries' continuing efforts to keep pace
with the rapidly changing information technology environment.
Indeed some of our libraries are at the forefront of the web-
based revolution, but many others need to accelerate their
initiatives.
--We need to recognize the important contributions that libraries
make to the social, civic, and educational health of their
communities. Like many schools, libraries often serve as the
hubs of their communities and provide important services,
training in technology and opportunities for life-long
learning, particularly in traditionally under-served areas.
THE LIBRARY SERVICES AND TECHNOLOGY ACT (LSTA)
I am please to convey ALA's deep appreciation to the Subcommittee
for the support it has provided in the past for libraries and Federal
library programs, particularly your support of the Library Services and
Technology Act (LSTA) state grant program; library services to Native
Americans; and the national leadership grants program.
FISCAL YEAR 2002 FUNDING REQUEST: $350 MILLION FOR LIBRARIES
The library community has collaborated on developing a draft for
the reauthorization of the Library Services and Technology Act and will
be working with the House and Senate authorizing committees this year
on the reauthorization. The current authorization expires at the end of
fiscal year 2002. We are seeking to increase the authorization level to
$500 million. As you know, this represents a significant expansion in
the Federal government's commitment to the support of our nation's
libraries. Today we request your support for fiscal year 2002 for a
down-payment of $350 million for library programs authorized under the
Library Services and Technology Act.
Libraries are making great strides in preparing for and introducing
technology to their users. With this increase more libraries could
expand their services to include technology training and access to the
world wide web for their users.
It would also enable libraries to provide additional badly needed
services to underserved populations in their communities. These
outreach efforts can pay off in terms of literacy programs that enable
students to achieve success in education and programs for families who
may not have used libraries before. Library programs for young children
encourage pre-reading skill development and stimulate a love of
reading, but only if funds are available for these programs.
It is important to note that funding for the State grant program
for libraries has not increased significantly in recent years. In
fiscal year 1997 it was $136,369,000; in fiscal year 2001 it is
$148,939,000. Library services are not keeping pace with the increases
in populations in most States.
In fiscal year 2001, the total distributed to states was
$148,939,000 and of that, Pennsylvania received $5,964,319. The state
library has already received requests for over $6,892,604, and expects
at least requests for $3 million more in the second round of grant
requests in the fall. An increase in state distribution to $350,000,000
would bring Pennsylvania dollars up to roughly $11 million. This
doubling of funds could enable more outreach to Pennsylvania's rural
areas, more attention to technology, and more resource sharing for all
libraries, school, academic and public in Pennsylvania. State libraries
always report that the requests for funds are double and sometimes
triple the amount actually awarded.
$400 MILLION FOR TITLE VI--INNOVATIVE EDUCATION PROGRAM STRATEGIES
We also ask that you fund the Elementary and Secondary Education
Act Title VI block grant at least at the $400 million level. We
appreciate your support of Title VI, particularly since it is the only
current funding possibility for school libraries. As you know, school
library materials are only one option of many in the block grant and
less and less of the funds are being used for school library materials.
As a result, many school libraries have old, outdated and
inaccurate material on their shelves. In research done in Alaska,
Pennsylvania and Colorado, it was found that a good school library
media program is an excellent predictor of improved student
achievement. That is why we feel it is so important to provide adequate
funding for school libraries.
21ST CENTURY COMMUNITY LEARNING CENTERS
We support funding for the 21st Century Community Learning Centers
program. School library media centers have the potential to be after-
school learning centers. If properly equipped and adequately staffed by
professional library media specialists, school library media centers
are a perfect place for after school learning. Currently, public
libraries as part of a consortium also can function as after school
learning centers. Many places, particularly in large urban areas like
Chicago, Baltimore, New York and Miami, perform that service, however,
the bulk of the grants are used by schools. We support initiatives to
allow public libraries and other community organizations to be the lead
agency.
IMPACT OF LIBRARIES
No public institution maximizes a modest amount of federal funds to
greater public benefit than libraries. Libraries are efficient users of
federal dollars. Funds are leveraged to attract other dollars; to
demonstrate new and innovative methods of providing service; and to
bring new users into the library for learning, literacy and the
information needed for more productive daily living.
IMPORTANCE OF TECHNOLOGY
Both school and public libraries have made great strides towards
the goal of full Internet access. However, effective public access is
far from complete. We believe that the E-rate telecommunications
discounts are critical to our nation's libraries. The library community
believes that this program must be continued in its current form. The
first three years of this E-rate fund have created the stimulus for
more schools and libraries to connect to the Internet, particularly in
areas where the discounts have been the greatest. The progress has been
immense and needs to continue. Over 95 percent of public libraries
offer Internet access to their patrons.
Moving the program from its fund status to one supported by the
appropriations process would be difficult and likely result in a strain
on other important education programs and a reduction of the amount
available. Telecommunications providers like BellSouth are so
enthusiastic about the program that they are providing training to help
schools and libraries apply. Please do not disrupt this program--it
works.
Federal funding supports the continuing investment libraries must
make in computer hardware and software, electronic content and training
for staff and the public. An increase in LSTA program funding to the
$350 million level would allow more of the 16,047 library outlets to
connect to the Internet and begin to provide training and information
access services to families, adult learners, the small business sector
and all in the community who need access. Sixty-five percent of all
households use public library services each year, according to data
from the National Center for Education Statistics.
______
Prepared Statement of the National Association of State Workforce
Agencies
BUILDING A STRONG WORKFORCE
The members of the National Association of State Workforce Agencies
are the state leaders responsible for building and overseeing workforce
development activities through the administration of a one-stop center
infrastructure and the implementation of workforce-related programs.
These programs include labor exchange activities, Internet job
matching, unemployment insurance administration, labor market
information services, veterans' employment services, job training and
welfare-to-work programs. Several critical components of this publicly
administered workforce development system--unemployment insurance,
employment services and labor market information programs--are financed
through taxes on employers. Thus, a strong connection to the needs of
the private sector business community is critical to the continued
viability of the workforce development system.
The primary emphasis of current workforce development efforts in
the states is the connection of employers with job seekers. In each of
the states, the workforce development system plays a vital role in the
success of the local economy by providing services that build a
stronger workforce, enhance employee skills, and promote economic
development by helping attract and retain large and small businesses.
In addition, with implementation of the Workforce Investment Act of
1998 (WIA), the new workforce development infrastructure being
developed in each of the states strives to address the changing needs
of the new economy by empowering individuals to make appropriate job
choices including enhancing their skills through training
opportunities. At the core of this new paradigm is understanding the
needs of business in the new economy and preparing workers who can
immediately contribute to the health of a company and allow economic
growth to continue.
As state workforce officials strive to marshal the resources within
a state and build this much needed system capacity, their role has
become even more important as they serve as:
--Leaders and change agents in creating a workforce vision and
implementing new services and opportunities for businesses and
workers;
--Partners with various federal, state and local officials who each
share responsibility for the new workforce development system;
--Overseers of a customer-driven system that focuses on the needs of
employers and job seekers;
--Supporters of the one-stop center system who work closely with
local planners in developing service delivery systems that
match customer wants and needs; and
--Facilitators of systems integration so that services can be
provided seamlessly.
While providing leadership and building strong workforce investment
systems, state administrators are facing two unique challenges which
come as a result of economic forces and highlight the need for adequate
workforce system funding. The first is company ``churning,'' where
American workers with low skills are displaced while job growth is
occurring in high skills industries, and the second is the pending
economic slowdown that might turn into a recession.
With these two factors as a backdrop, I want to outline the
important need to increase funding for (1) unemployment insurance
administration to ensure the economic safety net for workers is strong
enough to withstand an economic slowdown, (2) the employment service as
the cornerstone of one-stop center systems and the connection between
employers and job seekers, (3) WIA training and labor market
information to assist customers with market-based solutions to their
employment needs, (4) incumbent worker training to assist with business
and employer needs in the changing economy, and (5) veterans'
employment and training. These funding improvements, along with the
system improvements that are occurring, can support employers and
workers who are hardest hit by emerging economic changes.
FIRMS ``CHURN''
The aggregate economy has seen the largest boom in history, with
economic expansion running into its ninth year in 2000. The
unemployment rate fell for seven straight years, from 7.5 percent in
1992 to 4.1 percent in 1999. An unemployment rate of 4.1 percent was
the lowest level in 30 years. After accounting for inflation, median
weekly earnings of full-time wage and salary workers increased last
year, marking a third consecutive year of gains in real earnings.
Yet, workforce system builders have seen unique challenges during
the good economic times as firms ``churn'' employees. In a recent
survey, the American Management Association found that 36 percent of
the approximately 2,000 companies contacted created new jobs at the
same time that they cut existing jobs.
The demand for skilled labor has forced employers to adapt quickly.
Companies that once engaged in employee retraining or waited for
employees to leave voluntarily find that the quickest alternative is to
replace these workers with new employees who have skill sets currently
in demand. This leaves the workforce development system with the large
challenge of retooling a whole set of workers with outdated skills,
while serving employers with large gaps in their workforce due to a
lack of qualified workers.
To solve this problem, the workforce development system is actively
engaged in assisting employers with the skills training that workers
need to keep updated on new technologies and new workplace production
methods. Workers must adapt to new technologies in order to remain
competitive in the labor market. An important partner in this effort is
the education community, and in many areas of the country, the
workforce development system and the community college system have
developed programs that assist workers with on-the-job training and
skills retraining.
Technology is playing an ever-increasing role in productivity gains
made by businesses and the way workers conduct their jobs. Technology
is also becoming a critical tool for job seekers and employers looking
to hire. The Internet allows job seekers to sift through a whole host
of jobs at their convenience, while employers can post jobs and also
search through resumes. State workforce agency administrators are
proponents of using technology to assist employers and job seekers in
making more informed decisions and have implemented job matching and
other workforce technology into service delivery systems.
AN ECONOMIC SLOWDOWN?
Recent news headlines point to a coming economic slowdown. While it
is not known to what extent the economy will contract, what is known is
that the growth rate of recent years is not sustainable. This means
that unemployment will grow and workers will lose jobs, even in the
high tech sector. Efforts at preparing for a slowdown, and even a
potential recession, have been undertaken during the past year. For
example, the states are providing leadership in efforts to strengthen
and improve administration of unemployment insurance and the employment
service system.
UNEMPLOYMENT INSURANCE AND EMPLOYMENT SERVICES
Last year, representatives from the states, United States
Department of Labor, business and labor met to craft a package of
reforms that included, among other things, repeal of the Federal
Unemployment Tax Act (FUTA) 0.2 percent surtax and unemployment
insurance and employment services administrative funding improvements.
A hearing was held last September before the House Ways and Means
Subcommittee on Human Resources. Because of the short legislative
timeframe and the intense budget negotiations that lasted into fiscal
year 2001, no further action on unemployment insurance and employment
services reform was taken in the 106th Congress.
Because a number of governors have expressed support for this
reform, as well as a number of state business organizations, it is our
intent to work on a bill this year. Meanwhile, until the long-term
structural changes are enacted, states are struggling in the short-term
to maintain an essential infrastructure for the unemployment insurance
and employment service system that meet the needs of businesses and
workers.
These issues get to the core of the success of the nationwide one-
stop center system. If unemployment insurance and employment services
continue to be neglected, then the essential ``job connection'' that
has successfully moved unemployed and dislocated workers into
meaningful employment and assisted single mothers on welfare with job
skills and job attachment will be lost. States are now closing offices
in local communities and reducing staff--substantially decreasing
needed services to employers and job seekers. We urge the Congress to
fund fiscal year 2002 unemployment insurance at $2.65 billion, which
reflects need based on workload.
We also urge the Congress to fund the Employment Service State
Allotments at $933 million and Reemployment Services at $35 million.
Our request for Employment Service State Allotments represents the
current appropriation of $761.7 million plus the amount that state
legislatures have funded--$135,033,684--through state appropriations,
plus a four-percent growth allowance. It is a travesty that state
legislatures must essentially double tax employers to provide needed
employment services while FUTA taxes are building excessive balances in
the unemployment trust fund.
It is also disheartening that Congress does not provide adequate
funds for a program that yields measurable cost savings. A recent study
of the public labor exchange in Washington and Oregon indicates that
direct placement services conducted through the public employment
service return as much as two dollars for every one dollar spent. This
is a result of reduced unemployment insurance payments as unemployed
job seekers gain quicker reentry into the labor market. In addition,
the employment service assists employers by filling job vacancies more
quickly, enhancing companies' productivity.
This study of Washington and Oregon validates a broader study
conducted in 1999 that found similar results:
--Job search assistance participants found a new job more quickly and
the duration of unemployment insurance benefit payments was
reduced.
--Savings to the government averaged two dollars for every one dollar
spent.
--Shorter job searches did not lead to jobs that paid less.
We urge you to address funding shortfalls for the unemployment
insurance and employment service system.
WORKFORCE INVESTMENT ACT
In 1998, Congress passed the Workforce Investment Act, the first
major reform of the nation's job training system in over 15 years. It
was designed to replace the patchwork federal system that developed
over the last sixty years with a locally designed and driven system to
improve the quality of the workforce, enhance the productivity and
competitiveness of the nation and reduce welfare dependency. The
Workforce Investment Act took effect on July 1, 2000. It passed by a
wide bipartisan majority, in part because it was designed to permit
communities and states to build a workforce investment system that
respects individual choices, reflects local conditions, and results in
increased employment, retention, and earnings of participants, and
increases occupational skills attained by participants.
The Workforce Investment Act redesigned the nation's workforce
development system to:
--Streamline multiple employment and training programs into an
integrated one-stop center system, simplifying access to
services for job seekers and employers.
--Empower individuals to get the services and skills they need to
improve their employment opportunities through qualified
training programs of their choosing.
--Increase accountability of states, localities and training
providers for their performance based on job placement rates,
earnings, retention in employment, skill gains, and credentials
earned.
--Involve local elected officials and the private sector in business-
led boards for the local areas focusing on strategic planning,
policy development and local oversight.
--Allow state and local flexibility to implement innovative and
comprehensive workforce investment systems to meet the needs of
their communities.
--Improve youth programs by creating Youth Councils that are linked
more closely to local labor market needs and the community.
Partnerships at all levels--local, state and federal--and across
the system are the hallmark of the new workforce investment system. All
levels are required to coordinate and collaborate with agencies and
entities that have not been a part of the traditional workforce
development system. Accountability and responsibility for outcomes at
all levels of the system now exist, with each level having unique and
integral roles and responsibilities.
The goal of the Workforce Investment Act is to provide employment
and training services in a one-stop environment. Under the former job
training program, the Job Training Partnership Act, training was
limited to eligible populations. Under the new law, no eligibility
criteria exist, and services are universal. We recognize that, in the
first year of implementation, spending on training services is low.
However, the only way to address the growing skills gap between
employers' needs and workers' skills is through training. We support a
fiscal year 2002 appropriation of $988 million for Adult Training,
$1.147 billion for Youth Training, and $1.1653 billion for Dislocated
Worker Assistance that is essentially a current services budget for WIA
programs with a four-percent increase over fiscal year 2001 levels.
KEEPING WORKERS ATTACHED TO JOBS
In addition to providing basic employment and training services, we
strongly believe that the workforce system must assist incumbent
workers as they upgrade their skills and keep their individual
portfolios viable, while at the same time meeting their company's
evolving labor needs. We support $30 million in Workforce Investment
Act funds for incumbent worker training. Our competitive advantage in
the world economy rests in large measure on upgrading our workers'
skills.
LABOR MARKET INFORMATION
Providing labor market statistics for use by job seekers and
employers at the local level, rather than just on the national and
state level, is a new service expectation. In order to provide more
localized information as well as program performance information,
considerable enhancements to statistical programs and information
systems are needed. These enhancements will pay off as local labor
market needs will be more accurately assessed and employment programs
can be tailored to meet the needs of local employers. Therefore we
support a four-percent increase for the Bureau of Labor Statistics for
a total appropriation of $213 million, and a continued investment in
One-Stop/ALMIS dollars of $150 million. We also ask that report
language contained in last year's appropriation for One-Stop/ALMIS be
included as bill language in this year's appropriation bill.
The bill language we request reads, ``One-Stop/ALMIS funds will be
used to support infrastructure upgrades at the state level for one-stop
center system operations, labor market information, and integrated
services to employers and job seeker customers.'' This will ensure that
the dollars go to the states, where infrastructure needs are most
critical.
MEETING COMMITMENTS TO VETERANS
Our society recognizes the important contribution that veterans
have made, and Congress has taken that recognition and turned it into a
commitment. Title 38 of the U.S. Code includes provisions for special
employment services for veterans. Priority is given to disabled and
Vietnam era veterans, through the Disabled Veterans Outreach Program
(DVOP) and the Local Veterans Employment Representative (LVER) program,
which are administered by state workforce agencies. DVOPs and LVERs
also serve our veterans population by helping to ensure a smooth
transition for people moving from military service into the civilian
workforce.
Title 38 provides formulas to determine DVOP and LVER staffing
levels. Since 1990, appropriations for DVOPs and LVERs have not
supported the number of positions authorized by the statutory formulas.
We strongly encourage support for funding at the statutorily-authorized
levels of $121 million for the DVOP program and $102 million for the
LVER program. This will help us follow-through on our commitment to the
men and women who have served valiantly in the military both in times
of war and peace.
CONCLUSION
I do believe we are making significant strides in building the
workforce investment system in each of the states. With a potential
slowing of the economy, we cannot afford to wait any longer for the
improvements that need to be made so that families can be served with
their workforce development needs. With additional investments by
Congress, I know that we are prepared to help those citizens needing
job placement or skills training assistance and those businesses
looking for good, solid workers who can improve their economic
prospects. Thank you for your interest and support.
______
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 150,000 federal employees NTEU
represents, thank you for permitting NTEU to share our views concerning
the fiscal year 2002 budget.
NTEU represents employees in a number of HHS agencies including 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. NTEU also represents employees in the Social Security
Administration's Office of Hearings and Appeals.
As the Chairman knows, funding remains severely constrained at
federal agencies, leaving agencies with insufficient resources to
complete their missions or adequately reward their employees. Funding
shortfalls have resulted in hiring restrictions and delayed and
canceled employee training, making it difficult for employees to do the
best job possible. Moreover, with federal salaries continuing to lag
well behind similar private sector salaries, agencies have been unable
to hire or keep the expertise they need.
In fact, the looming crisis in the federal government recently
caused the General Accounting Office to place human capital management
on its High Risk List. The GAO stressed that federal employees are
assets to be valued, not costs to be cut. Adequate and stable agency
funding coupled with appropriate pay, benefits and incentives are the
keys to insuring that the federal government continues to attract and
retain the right federal employees.
With surpluses predicted for the immediate future, the opportunity
exists 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. Unfortunately, the President's budget calls for an average 4
percent increase in discretionary agency funding, an amount clearly
inadequate to address the crisis the federal government faces and move
human capital management off the high risk list. If there is room in
the federal budget for a tax cut in excess of $1 trillion, clearly
there is room to adequately fund federal agencies.
The Administration's fiscal year 2002 budget request for program
management at the Health Resources and Services Administration (HRSA)
is $154 million. Although this figure represents a $9 million increase
over program management funding for fiscal year 2001, the budget also
calls for a reduction of 24 FTE in the next fiscal year. I think this
shows quite clearly how inadequate the proposed $9 million increase is.
HRSA's goal is to bring health care services to some of our neediest
populations, including those in underserved rural communities, people
living with HIV/AIDS, and those who are uninsured. HRSA provides
essential services that are desperately in need of expansion; they
cannot accomplish their mission with fewer employees and inadequate
resources.
The employees represented by NTEU at the Agency for Healthcare
Research and Quality (AHRQ) strive to improve 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 fiscal year
2002 budget proposal calls for $3 million for program support at the
AHRQ, the same amount the agency received in fiscal year 2001. AHRQ
will not be able to continue its mission and maintain its current staff
without additional funding.
Likewise, the Administration's budget proposes no increase 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 using drugs. SAMHSA also plays a critical role in
insuring that mental health and drug abuse services are widely
available to populations that would otherwise receive no services. If
SAMHSA is to adequately respond to the substance abuse and mental
health needs in this country, they will require an increase in funding.
In fiscal year 2001 the agency received $67 million and 632 FTE. The
President's budget freezes the agency at an identical, and
insufficient, level for fiscal year 2002.
Under the President's budget, the Indian Health Service (IHS) is
slated to receive $2.9 billion for its health services programs in
fiscal year 2002. This budget request reflects a small increase of $151
million over the fiscal year 2001 level of $2.8 billion which NTEU
believes fails to recognize and value the important work this agency
does in improving health care for the millions of American Indians and
Alaska Natives. A substantial increase is warranted here as well.
The fiscal year 2002 budget request for federal administration at
the Administration for Children and Families (ACF) is $182 million, an
$8 million increase over fiscal year 2001 funding. 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 2002 budget
request would severely hamper ACF's ability to continue to provide
quality services. It envisions permitting the agency to hire no more
than 15 additional staff in the next fiscal year, a number that does
not reflect the importance these employees play in overseeing the
critical Head Start Program. Funding restrictions in past years have
already hampered ACF's ability to fulfill its mission and I urge the
Subcommittee to provide additional fiscal year 2002 funding over and
above the President's request.
For fiscal year 2002, $18 million is requested for program
administration at the Administration on Aging (AoA), a $1 million
increase over the agency's fiscal year 2001 funding level. America's
elderly population continues to grow and helping older Americans remain
independent and productive is one of the key goals of AoA. The
employees of AoA operate nutrition programs and are active in the
Alzheimer's programs. To continue and expand its work, the AoA, too,
requires funding increases that reflect its critical mission.
NTEU also represents employees in the Office of the Secretary of
HHS. The President's budget request for departmental management is $450
million for fiscal year 2002, an increase of $68 million over fiscal
year 2001 funding levels that will allow the agency to hire an
additional 107 FTE. As you know, the employees in the Office of the
Secretary help support those activities associated with the overall
operation of the department and NTEU hopes the Subcommittee will
support this proposed increase.
The President's budget request for the Office for Civil Rights
(OCR) for Fiscal 2002 is $32 million, an increase of $4 million over
the fiscal year 2001 funding level. HHS's Office for Civil Rights
enforces the Nation's civil rights statutes that prohibit
discrimination in 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 past years, the
funding levels OCR has received have not reflected OCR's critical
mission and NTEU urges the Subcommittee to provide the maximum possible
increase to OCR in fiscal year 2002.
For the National Center for Health Statistics (NCHS), the
Administration has requested $127 million for fiscal year 2002, an
increase of $5 million over the fiscal year 2001 level. 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 NCHS
deserves the maximum possible allocation for fiscal year 2002.
As the name implies, the Department's Program Support Center (PSC)
provides support services to HHS and other agencies. These services
include efforts in three areas, including human resources, financial
management and administrative operations. For fiscal year 2002, the
Administration has recommended a funding level of $308 million for PSC,
a small increase over the division's fiscal year 2001 budget that NTEU
hopes can be increased during Subcommittee deliberations.
NTEU also represents employees in the Office of Hearings and
Appeals (OHA), and as I have brought to this Committee's attention in
past years, OHA is again the subject of reorganization. The latest, the
Hearing Process Improvement (HPI) plan, is not working.
As you know, disability claimants who have been found ineligible
for disability benefits are entitled to a timely and fair hearing of
their cases at the OHA level. In 1995, the Social Security
Administration began an innovative program called the Senior Attorney
Program, which, in every respect, was a resounding success. The
agency's experienced staff attorneys were given the authority to decide
and issue fully favorable decisions--without the time and expense of a
full hearing--in those cases where the evidence clearly identified an
individual as disabled. It materially improved both the quality and
timeliness of service provided to the public. Despite the success of
the Senior Attorney Program, the Hearing Process Improvement Plan
eliminates it, largely due to opposition from Administrative Law
Judges.
From 1995 until it was canceled in 2000, nearly 230,000 Senior
Attorney decisions were issued. It is noteworthy that the SSA Appeals
Council found no significant difference in the accuracy of Senior
Attorney decisions vs. full, on the record decisions made by the
agency's Administrative Law Judges. Moreover, these Senior Attorney
decisions helped reduce the backlog of cases at OHA to 311,000 by
September of 1999. That backlog is now on the rise.
The average processing time for a case favorably decided by a
Senior Attorney was approximately 105 days. This was at a time when
processing time for cases at OHA took approximately 386 days--more than
a full year. Senior Attorney decisions helped deserving claimants
receive their benefits in a more timely fashion while simultaneously
not wasting valuable agency resources.
Since the Senior Attorney Program was terminated, the backlog of
cases has risen at an alarming rate with almost 390,000 cases awaiting
processing today. Without the Senior Attorney Program these cases will
wait about 314 days to be processed. Even worse, the situation is
expected to continue to deteriorate. There can be no significant
reduction in the case backlog or case processing time without reviving
this program. The Senior Attorney Program can help the agency address
these problems with current resources and stem the decline in the
quality of services nationwide. It does so without hiring new
Administrative Law Judges and staff and it presents an immediate
solution to a worsening problem. I urge you to question the agency
concerning this matter as soon as possible.
Thank you again for permitting NTEU to share our views on the needs
of the agencies within the jurisdiction of your Subcommittee.
______
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 eight U.S. electric consumers (about 40 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 2002
appropriations for the Low-Income Home Energy Assistance Program
(LIHEAP).
APPA urges the Committee to support LIHEAP at its maximum funding
level of $2 billion in fiscal year 2002. APPA also supports a minimum
of $300 million in emergency funds in fiscal year 2002 and supports a
funding level of at least $2 billion in advanced funding for fiscal
year 2003. In addition, APPA supports the numerous amendments being
considered in the Senate to increase the current $2 billion funding
authorization level of LIHEAP. 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, escalating
home heating oil prices in the Midwest and Northeast and higher than
expected utility bills in California have depleted fiscal year 2001
emergency funds and highlight the important role LIHEAP plays for the
elderly and working poor during winter months and for all consumers
when energy prices are volatile.
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. This
prophesy has come true for consumers across America this winter as we
witness price spikes in all areas of fuel production, including natural
gas, home heating oil and electricity. 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.
APPA is proud of the commitment that its members have made to their
low-income customers. Many public power systems have low-income energy
assistance programs based on community resources and needs. APPA
continues to remind its members of how important it is to have in place
a well designed low-income customer assistance program, in tandem with
energy efficiency and weatherization programs, that can help consumers
hold down their energy bills and lower their requirements for
assistance.
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 2002 funding for LIHEAP. Again, thank you for this opportunity to
present our views.
______
Prepared Statement of the Association of America's Public Television
Stations
The Association of America's Public Television Stations submits
this testimony to the appropriations subcommittee on Labor Health and
Human Services, Education and Related Agencies. APTS, on behalf of the
nation's 354 local public television stations, urges the committee to
support funding for the Corporation for Public Broadcasting and the
Ready to Learn and TeacherLine projects within the Department of
Education.
This year APTS is asking Congress to fund the Corporation for
Public Broadcasting in fiscal year 2004 at $395 million. This modest
$30 million increase will help pay for increases in system support such
as royalties and copyright fees as well as funds to support projects to
develop new content for our increased educational services and
programming. Most significantly, this request would mean an average
increase of $90,000 per station in the form of Community Service
Grants. Eighty nine percent of CPB's funding goes to local public
television and radio stations in the form of CSGs, which are the seed
money for local operations. These federal funds are leveraged an
average of six fold to raise non-federal funds to enable local stations
to serve their local communities.
APTS thanks the committee for its generous past support and for
acknowledging the special needs of public broadcasting in the form of
advanced appropriations. The advance funding provision for CPB allows
public broadcasting and local stations a predictable source of support
that can be applied to research and development. It also provides the
important lead time needed to leverage other funding sources necessary
to bring programs to the air.
Public television also requests that the subcommittee provide
funding for the Ready to Learn program at $24 million and the
TeacherLine project at $8.5 million in fiscal year 2002. Both of these
programs are administered through the Department of Education. The
Ready to Learn program provides funding for the development and
production of the highest quality children's educational programming.
It also assists local stations in their outreach efforts to train
teachers, parents and day care providers to effectively use these
programs to teach young children. TeacherLine is an online professional
development initiative that helps teachers improve their teaching
skills in core subject areas.
Public broadcasting is also seeking equipment funds for the
federally mandated conversion to digital through the Public
Telecommunications Facilities Program (PTFP) within NTIA at the
Department of Commerce.
COMMITMENT IN THE DIGITAL AGE
Public broadcasters historically have been the leaders in using new
technologies for education and public service. The nation's public
television stations stand ready to make an historic commitment to all
Americans to provide near universal access to wireless, high-speed data
for education. Specifically, public television stations will commit the
equivalent of one multicast digital channel--a daily average of 4.5
megabits per second (Mbps), among the highest data rates available--for
formal early childhood, K-12, and post-secondary education, as well as
workforce training and professional development. This digital capacity
is conservatively valued at $2.4 billion per year.
HARNESSING DIGITAL TECHNOLOGY TO SERVE THE PUBLIC
With roots going back to the earliest days of radio and television,
America's public broadcasters have played a unique role in a media
industry that is otherwise built on consumer advertising and mass
market entertainment. Since the 1960s, publicly funded noncommercial
television has provided a clear alternative to commercial television,
focusing on education and culture, public affairs and the performing
arts.
While the proliferation of television channels has been driven by
market demands, public television's core mission has not and will not
change in a digital world. We will build on our track record of
providing the best programming and services to educate and enlighten
audiences. We also will continue to be leaders in using new technology
for the public interest. From satellite delivery of broadcast signals,
to the development of stereo broadcasting; from closed captioning and
descriptive video services, to video streaming and cutting edge
interactive television trials, public broadcasters have been inventors,
innovators and blenders of technologies to serve the public.
Public television is committed to use digital technologies to
transform the way we learn--by providing the American public with
educational services anytime anywhere. That means how they want them,
when they want them and where they want them--in homes, schools,
childcare facilities, and workplaces across America.
MULTICAST DIGITAL SERVICES--UNLOCKING PUBLIC TELEVISION'S PUBLIC
SERVICE MISSION
Since receiving their digital channels, public television stations
have been engaged in systemwide and station level planning. In 1997,
public broadcasting put forward a comprehensive plan for its digital
conversion to the Administration and Congress. We set four broad
systemwide goals for the use of digital technology--goals that are
founded on fully utilizing the multicasting capability of the digital
technology to expand and enhance services.
To make the full complement of Ready to Learn services available to
every child, parent and caregiver in America.--The PBS Ready to Learn
Service is currently meeting two national education goals: it teaches
basic reading skills and it helps prepare more children for school
success. Its 133 participating stations cover over 94 percent of the
country. In the past three years, RTL public television stations have
trained 370,000 parents and 250,000 teachers and caregivers, affecting
approximately 6 million children.
To expand the reach of public television's K-12 educational
programs and services by making them universally available to all
schools and home schoolers.--70 percent of public television licensees
provide K-12 programming in math, science, arts and humanities. These
services are enhanced by:
--PBS TeacherSource, an online K-12 teacher resource with online
lesson plans, teacher guides and activities, correlated to more
than 90 national and state standards; and,
--PBS Teacherline, online modules to enhance the learning and
teaching of K-12 mathematics and other core subjects.
To increase the reach of post secondary telecourses so that they
are universally available to all adult learners.--Collectively, public
television stations are the largest source of post-secondary
telecourses in the nation. PBS Adult Learning Service (ALS) supports
station-college partnerships that offer distance learning credit-
bearing telecourses, enrolling more than 500,000 students in 1999-2000.
GED on TV has enabled more than two million adults in five years to
earn their high school equivalency from home. The estimated positive
economic impact of these more productive workers exceeds $12 billion.
To expand our commitment to serving the unserved and underserved
populations in our country, those who because of economic, geographic,
physical, cultural or language barriers have been left behind by the
commercial marketplace.--Public Broadcasting has pioneered the
development of open and closed captioning for the deaf and descriptive
video services and reading services for the blind or visually impaired.
Stations like WYBE, Philadelphia and WNVC, Fairfax provide programming
in multiple languages serving a variety of different ethnic cultures.
Local public television stations throughout the country have turned
those systemwide goals into concrete and very bold and exciting service
plans tailored to their local communities. APTS maintains an
interactive clearinghouse of stations' plans for digital services. Our
data show that virtually every public television station in the country
has developed digital service plans to meet these and other goals. The
centerpiece of virtually every plan is the delivery of multicast
services with a strong focus on education.
--In exchange for federal financial support and favorable cable must
carry regulations, the nation's public television stations
stand ready to commit an average daily rate of 4.5 megabits per
second (approximately one channel) of their digital spectrum to
education. The value of this capacity is conservatively
estimated at $2.4 billion per year
--Three out of every four PTV stations plan to carry at least two
formal education multicast services.
--Approximately 85 percent of PTV stations plan to multicast a
children's channel; 78 percent intend to broadcast university-
level or post-secondary telecourses; and 66 percent plan to
multicast an instructional programming channel for students in
grades K-12.
--Others plan to multicast channels that focus on local public
affairs, teacher training, foreign language programming, and
programming aimed at minority and under-served audiences.
ptv digital service plans--creating local solutions for national
priorities realizing national educational goals on a local level
While public television stations plan to deliver one or more formal
educational multicast channel, the specific educational services are
tailored to meet local community needs.
Florida public television stations have promised the state
legislature that they will collectively devote a multicasting stream to
the Florida Knowledge Network in return for digital funding. This
statewide educational network will serve as a teacher training
resource, linking Florida's classrooms with direct access to the
highest quality programming, electronic field trips, and distance
learning.
New York's public television stations plan to dedicate one of their
multicast streams to an educational service called the Empire State
Channel. Developed with the state Department of Education, the Empire
State Channel will feature teacher training, vocational instruction and
public affairs programming.
providing unserved and underserved with access to digital technology
Today, public television stations, through their nationwide system
of transmitters and translators, serve 99 percent of American
households with an over-the-air analog signal. Public television
stations that serve rural communities with a network of analog
translators are ideally positioned to bring the benefits of broadband
digital services to the most rural and remote areas of this country.
KAET in Phoenix plans to partner with KUAT in Tucson to dedicate
one or two multicasting channels to feeding math, science, geography
and other educational programming to 300 schools throughout the
geographically diverse state. Directed by the stations and funded by
the state Department of Education and Arizona State University,
programming will relate directly to course materials, and teacher
training will be accompanied by curriculum guides, instructional
materials, and planning booklets that can be downloaded to computers in
the classrooms. These services are intended to reach students in the
farthest corners of Arizona, students who are unable to be linked via
telephone and fiber optic lines.
KNME in Albuquerque is considering leasing part of its digital
spectrum to the New Mexico Department of Education to facilitate the
delivery of educational materials to the state's K-12 schools. The
station will position itself as the state's virtual classroom,
providing curricular support and teacher training opportunities for
viewers separated by hundreds of miles. This arrangement would allow
the Department of Education to help with the costs of digital
conversion.
Public television stations also plan to use the multicast
capability to serve populations under-served because of cultural,
language or economic barriers.
KBDI in Denver plans to launch a Latino Initiative Channel. This
channel would feature programming for Denver's Spanish-speaking and
bilingual community and will emphasize news, public affairs, and social
and cultural events. Potential partners include local community service
organizations, schools, commercial Spanish-language broadcasters, and
public service agencies.
WNYE in Brooklyn and WYBE in Philadelphia plan to provide multicast
foreign language and international channels to serve the international
residents in their respective cities. The WNYE multicast channel will
feature programming in at least 12 different languages, including
Japanese, Chinese, Italian, Greek, Polish, and Eastern European
languages.
partnering with local institutions to solve local community problems
A key characteristic of public television's digital planning is
localism. In an age of increasing media consolidation, public
television stations remain the only locally owned, locally operated
television service in many communities. Consequently, several PTV
stations are planning ``local'' channels, focusing on specific
community needs.
Vermont Public Television plans a Vermont Public Service Channel,
which would provide regular coverage of the state legislature,
important legislative committee hearings and other statehouse-related
programs, as well as local government town meetings and debates.
Additional programming might include call-in programs with the Vermont
congressional delegation, travel and tourism information, and other
local news and public affairs programming.
The federal government must play its historic leadership role in
underwriting a portion of public broadcasting's digital transition. The
government's failure to make this investment will have direct
consequences. Millions of Americans may be deprived of the enormous
educational promise of digital television. Many of the smaller and
rural stations may be unable to make the transition at all.
The public broadcasting industry has updated its costs for the
digital transition. Balancing reductions for the stations currently on
the air against additions for increased costs, public broadcasters
estimate the total costs of conversion for both television and radio at
$1.8 billion.
CONCLUSION
For more than 30 years Congress has invested wisely in public
broadcasting. We now have a strong system of public television stations
that reaches 99 percent of American households, giving viewers tools to
improve and enrich their lives. The public service promise of new
digital technology is enormous:
--for children to provide a dedicated stream of nonviolent,
educational and entertaining programs, commercial-free and
free-of-charge;
--for parents and schools to better educate children;
--for colleges and universities to reach out beyond their campus
walls;
--for students of all ages to have access to lifelong learning;
--for under-served audiences whose income, geography, culture or
disability threatens to cut them off from the digital promise;
--for citizens who feel alienated from their local, state or federal
governments; and
--for public service organizations seeking to build a sense of civic
connection and commitment.
Realizing this potential and remaining a viable service provider in
the digital age is fully dependent on a federal investment to ensure
access to all digital services. Public television stands ready with
service plans, matching state and local grants, and community-based
content partners to fully utilize this technology for public service.
Funding for the Corporation for Public Broadcasting and through the
Ready to Learn and TeacherLine programs at the Department of Education
will provide essential financial assistance to stations in order to
meet their digital service goals.
______
Prepared Statement of the Motion Picture & Television Fund
Funding is requested by the Motion Picture & Television Fund
(MPTF), Woodland Hills, California, in fiscal year 2002 appropriations,
for an ``Eden Alternative'' demonstration project.
Nursing homes and assisted living facilities play a critical role
in the delivery of care to older people with chronic needs. It is
expected that over half of the people who turned 65 in 1990 will enter
such a facility before they die. Too often the stay is characterized by
feelings of helplessness, loneliness and boredom. It is presumed, but
untested, that these ultimately add to the cost of care because of an
increase in hospitalizations, medical problems, and the use of
psychotropic drugs. Any program that can reduce the frequency of those
problems would have major implications through a reduction of Federal
expenditures for health programs, including Medicare and Medicaid.
The Eden Alternative is an innovative approach which was developed
as a way to improve the quality of life of nursing home and assisted
living residents. This approach seeks to overcome the problems of
helplessness, loneliness, and boredom. It is intended to improve
quality of life and decrease medical problems and expense through
changes in the physical, psycho-social, and staffing environments.
MPTF, by this proposed demonstration project, seeks to validate that
improvement in both health outcomes and medical cost reductions can be
achieved by implementing the ``Eden Alternative'' concept in its
nursing home and assisted living community. A demonstration project of
this type can serve as a model for other similar community based
facilities nationwide.
The Federal Government and the Congress have a significant interest
and responsibility in the quality of life and access to long term care
by its older adults. This responsibility is particularly relevant when
in the near future the aging baby-boom generation will substantially
increase the number of United States citizens in retirement. By the
year 2030, all baby-boomers will be over 65 years old, with the oldest
nearing age 85. Twenty percent of the total United States population
will be elderly in thirty years, compared with 13 percent today, 20
percent of all those over 85 years old will be residing in nursing
homes. Since most, if not all, of these nursing home residents will be
on Medicare, the nationwide impact of a program which significantly
reduces medical costs should be a priority item of interest and
responsibility.
The Eden Alternative offers a paradigm shift that seeks to
transform the concept of institutional care. A central tenet is that
the environment should help maximize individual potential for personal
growth by offering variety, vibrancy and spontaneity. This approach
includes homelike furnishings, regular interaction with children and
young adults, resident responsibility for the care of companion animals
and plants, and flexibility in residents' daily activities to encourage
spontaneity. Perhaps most important is staff development which
facilitates the replacement of top down bureaucratic authority with
decision making that is closest to the resident, whenever possible.
Staff needs to be provided with the necessary training, skills and
information, in order to assume responsibility for the improved social
and medical outcomes. The change in surroundings results in an enhanced
sense of self, a higher quality of life, and a relief from the problems
that frequently affect nursing home and assisted living residents.
In addition to a plethora of environmental changes, the Eden
Alternative also promotes substantive changes in management philosophy
and style and organizational culture. Management principles include:
--Replacing top down bureaucratic authority with decision making that
is closest to the consumer whenever possible. This includes
empowering residents and those who provide the most direct care
and transforming the roles of staff to family-like companions
rather than medical care providers.
--Encouraging leadership that embraces change which is focused on
improving residents' quality of life. To support necessary
changes in the physical and work environment, leaders assume
the role of coaches. Leaders and staff are encouraged to reward
appropriate risk-taking, promote fundamental fairness, and
recognize that mistakes are part of change.
--Organizing work through self-directed work teams in contrast to
hierarchy and strict departmental lines. To ensure informed
decision making, team members are provided with necessary
information, resources, training and skills, knowledge, and a
supportive environment. Thus empowered, teams are responsible
for making decisions about how to meet their goals including
scheduling and organizing their work.
These innovations are believed to create a more desirable
environment for residents and staff and to result in improved health
status for residents. In addition to the relief of boredom and
helplessness that afflicts residents, preliminary work suggests that
such an enriched habitat improves residents' quality of life and leads
to such related benefits as reducing prescription mediation use;
reduced incidence of infections, skin breakdowns, and falls; less
depression; and improved sense of well being and control. Studies have
also suggested that an enriched environment positively affects staff,
resulting in less absenteeism, reduced turnover, and higher levels of
job satisfaction.
MPTF goals for this project are two-fold: (1) Implement the
environmental and staff changes necessary to achieve the life style
envisioned by the Eden Alternative (including programmatic changes and
staff training); and (2) Measure and report on specific parameters
related to quality of life and decreased medical resource consumption.
These parameters would include the use of psychotropic drugs, the
presence of skin ulcers, falls, and hospitalizations. In addition,
national data on specific outcomes in nursing homes has been collected
for several years. Our experience will be compared to these national
benchmarks. We believe that this demonstration project will confirm
significant financial savings for our residents and that these savings
will be applicable to Medicare and Medicaid if this effort is adopted
nationally. Once confirmed, we would share our experience and teach
other organizations how to effectively implement the operating
principles of the Eden Alternative.
MPTF is an 80-year old non-profit health and social service
organization which serves the Southern California entertainment
community. Among our services are a 195 bed long-term care facility and
a retirement community (independent and assisted living) of 120. In the
first quarter of 2002, we will be opening additional retirement housing
with a capacity of 95. Our residents are admitted regardless of their
ability to pay. It is because of our history of providing the highest
quality of life in the most cost-effective way possible that we seek
support for this transition in our care model.
______
Prepared Statement of the National Federation of Community Broadcasters
Thank you for the opportunity to submit testimony to this
Subcommittee regarding the appropriation for the Corporation for Public
Broadcasting (CPB). As the President and CEO of the National Federation
of Community Broadcasters I speak on behalf of 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:
--Requests $395 million CPB for fiscal year 2004, a $30 million
increase over fiscal year 2004 funding;
--Requests that advance funding for CPB is maintained to preserve
journalistic integrity and facilitate planning and local
fundraising by public broadcasters;
--Requests report language to ensure that CPB utilizes digital funds
it receives for radio as well as television needs;
--Supports CPB activities in facilitating programming services to
Latino and Native American radio stations;
--Supports CPB's efforts to help public radio stations utilize new
distribution technologies and requests that the Subcommittee
ensure that these technologies are available to all public
radio services and not just the ones with the greatest
resources.
Community radio fully supports $365 million for the Corporation for
Public Broadcasting in fiscal year 2004.--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.
For the past 25 years, CPB appropriations have been enacted two
years in advance. We are grateful for Senators Spector and Steven's
comments in support of continuing the advance appropriations. This
insulation has allowed pubic broadcasting to grow into a respected,
independent, national resource that leverages its federal support with
significant local funds. Knowing what funding will be available in
advance has allowed local stations to plan for programming and
community service and to explore additional non-governmental support to
augment the federal funds. Most importantly, the insulation that
forward-funding provides ``go[es] a long way toward eliminating both
the risk of and the appearance of undue interference with and control
of public broadcasting.''--House Report 94-245.
In the last two years, CPB has increased support to rural stations
and committed resources to helping public radio take advantage of new
technologies such as the internet and satellite radio. We commend these
activities which we feel provide better service to the American people,
but want to be sure that the smaller stations with more limited
resources are not left out of this technological transition. We ask
that the Subcommittee include language in the appropriation that will
ensure that funds are available to help the entire public radio system
utilize the new technologies, particularly rural and minority stations.
NFCB commends CPB for the leadership it has shown in supporting and
fostering the programming services to Latino stations and to Native
American stations. Satelite Radio Bilingue provides 24 hours of
programming to stations across the United States and Puerto Rico
addressing issues of particular interest to the Latino population. In
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 year 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 era of communications.
Thank you for your consideration of our testimony.
______
Prepared Statement of the National Minority Public Broadcasting
Consortia
The National Minority Public Broadcasting Consortia (Minority
Consortia) submits this statement on the fiscal year 2004 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 ask
the Committee to:
--Reject the Administration's proposal to end forward funding of the
Corporation for Public Broadcasting
--Recommend at least $395 million for CPB for fiscal year 2004, a $30
million increase over fiscal year 2003
--Encourage CPB to increase its efforts for diverse programming with
commensurate increases for minority programming and the
Minority Consortia
--Support the Administration's request of $20 million for digital
conversion
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
Forward Funding.--We strongly oppose the Administration's proposal
that the advance funding for CPB be eliminated, a proposal that would
stop CPB funding for two years. We were pleased to see the colloquy on
the Senate floor April 6 between Senators Stevens and Specter
concerning this issue, and we support any efforts to continue the
practice of two years forward funding for CPB. Reasons to continue
forward funding for CPB include:
--The production of programming for public broadcasting usually takes
several years and substantial lead time is needed for planning.
--Public broadcasting programs are supported by multiple funding
sources, and two years advance knowledge of the amount of
federal funding allows CPB to better leverage its federal funds
to bring in other sources of revenue.
--The Minority Consortia administers a significant amount of CPB
programming monies, and elimination of forward funding would
negatively affect our organizations' planning and fundraising
activities.
CPB Appropriation.--We support a fiscal year 2004 federal
appropriation for CPB of at least $395 million. This 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.
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.
Digital Conversion Assistance.--We support the Administration's
request for $20 million for digital conversion funding for CPB. We also
urge Congress to enact the necessary authorizing legislation so that
these funds can be distributed.
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.
Part of the equation in bringing more high quality diverse
programming to public broadcasting is that independent producers be
able to transition to digital production. Federal funding for digital
conversion should include assistance for independent producers.
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 oft-stated
commitment of CPB and Congress for increased multicultural programming
combined with four years of funding increases make this an ideal time
for significant progress.
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 thank you
for your long time support of our work on behalf of our communities.
______
Prepared Statement of the National Public Radio
INTRODUCTION
Thank you for the opportunity to submit a statement for the hearing
record on behalf of National Public Radio (NPR) and the hundreds of
public radio stations that air NPR programming across the country.
Public radio offers diverse perspectives by airing a combination of
local and national public affairs and cultural programming, funded by
local and national sources, both public and private. Public
broadcasting raises nearly 85 percent of its funding from non-federal
sources, yet it requires help from federal sources to fully achieve its
programming mission.
Public broadcasters seek a $395 million appropriation for CPB in
fiscal year 2004 (for the past quarter century, CPB has received
appropriations two years in advance).--The CPB was established in 1967
to provide federal support to stations. A $395 million funding level
for the annual CPB appropriation would provide an additional $6.7
million for radio over last year. Of that $6.7 million, $5.2 million
would be available for local public radio stations to keep pace with
technological changes and to produce and to acquire content for a
number of technological platforms and, $1.5 million would allow CPB to
fund 10-15 new radio production projects in fiscal year 2004.
Public broadcasters urge the Subcommittee to maintain advance
appropriations for CPB.--The Administration and the House and Senate
budget resolutions have proposed to eliminate this long-standing
practice that preserves freedom of expression, affords program managers
more lead time to plan and organize activities, and provides seed money
for raising non-federal money.
Public broadcasters support the Bush Administration's request for
$20 million in fiscal year 2002 for local stations' transition to
digital technology.--The estimated cost for digital radio is $116
million for transmission only, excluding production equipment.
Thank you for your commitment to our nation's public broadcasters,
and the citizens and communities they serve.
A COMMITMENT TO LOCAL AND NATIONAL SERVICE
Public radio stations are committed to serving their local
communities for philosophical, geographical and financial reasons.
Philosophically, non-profit public radio stations' missions are to
serve their local communities with a variety of programs and
perspectives. For instance, the mission of WDUQ-FM in Pittsburgh, PA
states, ``WDUQ is a noncommercial, educational public radio station
licensed to Duquesne University. As a steward of this license, WDUQ
serves Duquesne, listeners and the community with high quality
programming and services to inform, educate, enlighten and entertain.''
As a result of these guiding missions, many public radio stations
provide listeners with more than headlines and traffic reports by
building local news departments that produce in-depth reports on
community issues. Moreover, stations air national and international
programming that connects listeners to broader sources of ideas,
cultures and events.
Geographically, stations are licensed locally and make all
significant operational and programming decisions. In fact, stations
are often the only locally owned media outlets in their communities.
NPR Members include stations licensed to communities, local school
boards and other local institutions, and private and public colleges
and universities. Specifically, 78 of NPR's Member licensees are local
communities (including several Native American tribes). In addition, 8
are school boards, 11 are state entities, 27 are private universities,
and 146 are state universities.
Public broadcasting has been a grassroots movement, joining diverse
regions and viewpoints around a common purpose of community service and
education. Because public radio's foundation was built by and is
maintained by local decision-makers and listeners, this local nature
preserves accountability to the people in the listening community.
This support is also reflected in the personal support dedicated by
listeners and viewers to their local stations. For instance, according
to CPB, replacing the work that volunteers contribute to public
television stations would require nearly an eight percent increase in
full-time staff, and for public radio more than a 14 percent increase.
Financially, public broadcasters are part of a successful public-
private partnership. Nearly 85 percent of public radio's funding comes
from non-federal sources. Stations are supported by a variety of
sources, including government, foundations, businesses and listeners.
Currently, local stations' listeners generally provide the largest
percentage of funding (approximately one third) for local stations.
Nevertheless, federal money is crucial because it helps public
radio stations plan, produce, acquire and air programs that attract
these non-federal funding sources. CPB funding acts as ``seed money'',
raising $6 of non-federal money for every $1 of federal funding.
A statutory formula governs all federal appropriations distributed
through CPB. Public television receives 75 percent of the CPB
appropriation while radio receives 25 percent. 93 percent of the radio
designated federal money goes directly to local communities. The other
7 percent of radio funds remain at CPB to support national radio
programming, which is awarded on a competitive basis. This money is
essential to support the unrivaled services public radio stations bring
to their communities.
ADVANCE APPROPRIATION FOR CPB
President Bush's budget document calls for a series of reforms to
the federal budget process, one of which is targeted on the ``abusive''
use of advance appropriations for short-term budgeting purposes rather
than for ``advanced appropriations enacted for programmatic . . .'' The
President's policy of limiting advance appropriations is reflected in
the House and Senate budget resolutions. This cap will effectively
preclude any advance appropriation to CPB for fiscal year 2004.
During the April 6, 2001 Senate debate of the budget resolution,
however, Senate Appropriations Committee Chairman Ted Stevens (R-AK)
and Senate Labor/HHS Appropriations Subcommittee Chairman Arlen Specter
(R-PA) expressed their concerns regarding the elimination of CPB's
advance appropriations. NPR and its Member stations sincerely thank
these two Senators and strongly support this effort to maintain advance
funding for CPB.
Advance funding preserves journalistic integrity by insulating CPB
from reactions to programming decisions. Advance appropriations also
afford program managers more lead-time to plan and organize their
activities. Moreover, advance appropriations provide seed money for
raising non-federal funding. Ordinarily, the decision to advance fund a
program is driven by a desire to insulate that program from the
uncertainties surrounding the annual appropriations process, such as
delays in enacting appropriations. Legislative history shows that it
was this reasoning that led Congress--backed by the recommendations of
three presidents--to place CPB on an advance appropriation basis
beginning in 1976. In fact, in 1975, President Ford sent a five-year
reauthorization to Congress with a five-year advance funding provision.
Subsequently in 1976, the Congress, in a bipartisan vote, established a
three-year funding practice with two-year advance appropriations that
has supported CPB ever since (Public Law 94-439).
DIGITAL RADIO CONVERSION
Like our friends in public television, NPR and its member stations
are excited about the possibilities of digital service and ``new
media.'' Public radio supports President Bush's budget proposal that
earmarks $20 million in fiscal year 2002 for CPB to help facilitate
public radio and television's transition to digital broadcasting. The
estimated cost for digital radio is $116 million for transmission only,
excluding production equipment.
Digital radio transmission technology is poised to deliver near
compact-disc-quality sound free of interference to listeners. Digital
production and transmission conversion will enable public radio
stations to produce and deliver programming using a far more efficient
process than currently exists. It may allow listeners and users to
experience a variety of new services such as the ability to search
program formats, scan selective programs and read music lyrics and song
titles.
U.S. broadcasters are developing a digital technology that works in
the existing AM and FM radio bands named In-Band, On-Channel or
``IBOC.'' The Federal Communications Commission (FCC) initiated a
digital audio broadcasting, or ``DAB,'' rulemaking in November 1999,
placing a high priority on preserving spectrum. IBOC DAB achieves
spectrum preservation by combining digital and analog signals within
the same AM or FM radio channel, thereby avoiding the need for
additional spectrum.
The National Radio Systems Committee (NRSC) will independently test
IBOC DAB in the Summer 2001. At some point after evaluation of the
additional testing, the NRSC is expected to make a recommendation to
the FCC on the selection of a standard. The FCC is awaiting this
industry recommendation before it endorses a digital transmission
standard.
NATIONAL SUPPORT FOR LOCAL EFFORTS: CPB FUNDED PROGRAMS
The majority of CPB dollars go to local stations to help sponsor
community outreach activities, create local programming and purchase
national programming from a diverse set of content producers. The
following are a few of the many examples of the local and national
programming that are supported in part by CPB funding:
KSKA-FM in Anchorage, AK.--Produces Community Forum. Host Robert
Howk and his guests discuss community issues and take listener calls
during this live, call-in broadcast. The station also partners with
other Alaskan public radio stations to produce and broadcast Alaska
Edition, an award-winning daily radio magazine. It is an hour-long mix
of news, interviews, music and commentaries written, produced and
hosted by Alaskans for Alaskans.
KPBS in San Diego, CA.--Partnered with the California League of
Women in the last election season to offer voters personalized election
information. Along with locally produced news stories, the feature
contained a sample ballot with candidate profiles, proposition
information, links to voter registration and polling place information.
Users could create their own portfolio of election information and
stories that interested them.
WOI Radio in Ames, IA.--Partners with St. John's Lutheran Church
Foundation, Essman/Associates to produce St. John's Forum, a series
devoted to promoting civil discourse on ethical questions and other
issues facing Iowans. Beginning its third season on WOI Radio, The
Forum is recorded before a live audience at WOI's studios in the Iowa
State University Learning Connection in downtown Des Moines.
WFPL-FM in Louisville, KY.--Broadcasts Louisville Forums,
programming that helps Louisville citizens learn about local issues and
ideas from people in the community. WFPL-FM broadcasts presentations at
the Downtown Rotary Club, the Louisville Forum, the University of
Louisville, the Louisville Free Public Library and other local venues.
The station also produces State of Affairs, a program offering
substantive discussion with an inquisitive host, informed guests and
thoughtful callers covering topics as diverse as politics and economic
development, to social issues, religion and arts.
New Hampshire Public Radio.--Produces Front Porch with John
Walters, a program dedicated to hearing from the Granite State's most
interesting people with a unique, creative approach to their work or
their life.
KNPR-FM in Las Vegas, NV.--Produces The Las Vegas I Remember, a
series devoted to the history of Las Vegas and Nevada told by those who
lived it. For instance, the program featured members of three of Las
Vegas' founding families. Another program examined the history of Las
Vegas after the building of the Hoover Dam.
WVIA-FM in Scranton, PA.--Broadcasts performances of artists who
perform and record in the magnificent space of St. Stephen's Pro-
Cathedral in Wilkes-Barre. Past performances have included organists,
choral groups and chamber music. The station also produces Art Scene, a
unique program bringing attention to the area's cultural events through
interviews, reviews and commentaries on films, books, jazz, and
classical music.
KERA-FM in Dallas, TX.--Airs The People's Agenda, a call-in show
exploring issues of public concern such as work, family, transportation
and crime. The show defines problems from the public's perspective,
examining how citizens are addressing local matters.
WXPR-FM in Rhinelander, WI.--Produces nearly a dozen programs such
as Northwoods Cafe, a mix of music from traditional, new and ethnic
folk music, as well as world music to some blues, cajun and zydeco
music.
NPR's.--Morning Edition is the premier national/local program on
public radio, with 10 million weekly listeners. The program is designed
to encourage local stations' news departments to report on community
news and events by inserting these stories into the national feed.
NPR's.--Lost & Found Sound is a collection of stories that
chronicles, reflects, and celebrates the changing sounds of this
century. Stories explore American life through sound--endangered
sounds, shifting accents, vanishing voices, the merging of languages,
the music of new technologies, and the soundscape of the streets.
NPR.--Distributes Latino USA, a national, English-language news and
culture program produced from a Latino perspective. It is a production
partnership of KUT Radio and the Center for Mexican American Studies at
The University of Texas at Austin.
CONCLUSION
Survey after survey finds that public broadcasting is valued and
supported enthusiastically by leaders of both political parties and by
Americans from all regions and walks of life. According to Roper Starch
Worldwide, a leading global marketing research and consulting firm,
public television and public radio are among the top five choices for
government services that provide excellent or good value for the tax
dollar.
Please support a $395 million appropriation for CPB for fiscal year
2004 and maintain advance appropriations for CPB. Moreover, please
support $20 million for public radio and television's digital
transition that is contained in the President's budget.
NPR is a private, nonprofit corporation that produces and
distributes award-winning programming such as Morning Edition, All
Things Considered, Performance Today, and Car Talk. NPR is also a
membership organization. NPR Member stations are independent entities,
licensed to a variety of non-profit organizations, local communities,
colleges, universities and other institutions. Public radio stations
independently select and produce community-appropriate programming that
best serve their listening areas rather than having these decisions
made by a centralized conglomerate.
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Alexander, David C., president, Auburn Engineers, Inc............ 169
Prepared statement........................................... 170
Alexander, Hon. Duane, M.D., Director, National Institute of
Child Health and Human Development, National Institutes of
Health, Department of Health and Human Services, prepared
statement...................................................... 300
Alpha One Foundation, prepared statement......................... 442
American Academy of:
Family Physicians, prepared statement........................ 450
Physician Assistants, prepared statement..................... 454
American Association of:
Geriatric Psychiatry, prepared statement..................... 457
Colleges of Nursing, prepared statement...................... 464
Colleges of Osteopathic Medicine, prepared statement......... 468
Colleges of Pharmacy, prepared statement..................... 470
Immunologists, prepared statement............................ 462
Pharmaceutical Scientists, prepared statement................ 471
American:
College of Cardiology, prepared statement.................... 472
Council on Education Coalition for International Education,
prepared statement......................................... 424
Dental Hygienists' Association, prepared statement........... 475
Gastrotenterological Association, prepared statement......... 482
Health Care Association, prepared statement.................. 25
Heart Association, prepared statement........................ 485
Indian Higher Education Consortium, prepared statement....... 417
Library Association, prepared statement...................... 684
Lung Association (ALA), prepared statement................... 478
Museum of Natural History, prepared statement................ 420
Psychological Society, prepared statement.................... 489
Public Power Association, prepared statement................. 693
Society for Microbiology, prepared statements..............498, 501
Society of Clinical Oncology, prepared statement............. 494
Society of Clinical Pathologists, prepared statement......... 496
Society of Tropical Medicine and Hygiene, prepared statement. 504
Thoracic Society (ATS), prepared statement................... 478
Association for Professionals in Infection Control and
Epidemiology, Inc., prepared statement......................... 507
Association of:
Academic Health Sciences Libraries, prepared statement....... 588
America's Public Television Stations, prepared statement..... 694
Minority Health Professions Schools, prepared statement...... 508
Schools of Public Health, prepared statement................. 444
Babyland Family Services, Inc., prepared statement............... 511
Barondess, Dr. Jeremiah A., chairman, panel on Musculoskelatal
Disorders and the Workplace, and president of the New York
Academy of Medicine............................................ 118
Prepared statement........................................... 120
Battey, Dr. James F., Jr., Director, National Institute on
Deafness and Other Communication Disorders, National Institutes
of Health, Department of Health and Human Services, prepared
statement...................................................... 302
Bigos, Dr. Stanley, Professor of Orthopedics, University of
Washington..................................................... 79
Prepared statement........................................... 81
Bonacum, Doug, director, Patient Safety, Kaiser Permanente....... 182
Prepared statement........................................... 184
Burton, Dr. Kim, director, Spinal Research Unit, University of
Hudderfield, United Kingdom.................................... 114
Prepared statement........................................... 116
Bushnell Center for the Performing Arts, prepared statement...... 422
Byrd, Hon. Robert C., U.S. Senator from West Virginia, questions
submitted by................................................... 289
Canavan Research Illinois, prepared statement.................... 514
Carper, Senator Thomas R., amendment proposed by................. 280
Cassman, Dr. Marvin, Ph.D., Director, National Institute of
General Medical Sciences, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 305
Chao, Hon. Elaine L., Secretary of Labor, Office of the
Secretary, Department of Labor................................68, 201
Letter from.................................................. 26
Prepared statements.........................................69, 206
Summary statement............................................ 203
Children's Heart Foundation, prepared statement.................. 518
City of:
Miami Beach, FL, prepared statement.......................... 520
Newark, NJ, prepared statement............................... 520
Coalition for Health Funding, prepared statement................. 525
Coalition of Northeastern Governors, prepared statement.......... 528
Cochran, Hon. Thad, U.S. Senator from Montana:
Opening statement............................................ 379
Question submitted by........................................ 249
College on Problems of Drug Dependence, Inc., prepared statement. 530
Collins, Dr. Francis S., M.D., Ph.D., Director, National Human
Genome Research Institute, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 307
Colonial Williamsburg Foundation, prepared statement............. 427
Community Medical Centers, Fresno, CA, prepared statement........ 532
Council of State and Territorial Epidemiologists, prepared
statement...................................................... 533
Craig, Hon. Larry E., U.S. Senator from Idaho, question submitted
by............................................................. 283
Crohn's and Colitis Foundation of America, prepared statement.... 537
Crownpoint Institute of Technology, prepared statement........... 439
Cure for Lymphoma Foundation, prepared statement................. 540
Dean, Hon. Donna J., Ph.D., Acting Director, National Institute
of Biomedical Imaging and Bioengineering, National Institutes
of Health, Department of Health and Human Services, prepared
statement...................................................... 311
Derebery, Dr. Jane, vice president of Medical Affairs, Concentra
Medical Services............................................... 136
Prepared statement........................................... 137
Digestive Disease National Coalition, prepared statement......... 541
Doris Day Animal League, prepared statement...................... 544
Drug and Alcohol Service Providers Organization of Pennsylvania,
prepared statement............................................. 578
Dystonia Medical Research Foundation, prepared statement......... 545
Easter Seals, prepared statement................................. 547
Eberhardt, Heidi, international trade specialist................. 107
Prepared statement........................................... 109
Epilepsy Foundation, prepared statement.......................... 552
Evanoff, Dr. Bradley, assistant professor of medicine, Washington
University School of Medicine.................................. 97
Prepared statement........................................... 99
Facioscapulohumeral Muscular Dystrophy Society, prepared
statement...................................................... 553
Families of Spinal Muscular Atrophy, prepared statement.......... 559
Fauci, Dr. Anthony S., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health,
Department of Health and Human Services........................ 293
Prepared statement........................................... 313
Feinstein, Hon. Dianne, U.S. Senator from California, questions
submitted
by............................................................. 291
Fellner, Baruch A. Esq., Partner, Gibson, Dunn & Crutcher, LL1, 76, 196
Prepared statement........................................... 78
Ficca, Stephen A., Associate Director for Research Services,
National Institutes of Health, Department of Health and Human
Services, prepared statement................................... 316
Florida State University, prepared statement..................... 430
Foundation for Ichthyosis & Related Skin Types, prepared
statement...................................................... 557
Frumin, Eric, director, Safety and Health, Union of Needle Trades
Industrial and Textile Employees............................... 175
Prepared statement........................................... 177
Gordis, Hon. Enoch, M.D., Director, National Institute on Alcohol
Abuse and Alcoholism, National Institutes of Health, Department
of Health and Human Services, prepared statement............... 318
Grady, Dr. Patricia A., Director, National Institute of Nursing
Research, National Institutes of Health, Department of Health
and Human Services, prepared statement......................... 321
Hadler, Dr. Nortin M., professor of Medicine and Microbiology/
Immunology, University of North Carolina, Chapel Hill.......... 83
Prepared statement........................................... 85
Harkin, Hon. Tom, U.S. Senator from Iowa:
Opening statements......................................28, 66, 252
Prepared statements....................................... 202, 390
Questions submitted by............................59, 238, 284, 404
Hepatitis Foundation International, prepared statement........... 560
Hodes, Dr. Richard J., Director, National Institute on Aging,
National Institutes of Health, Department of Health and Human
Services....................................................... 293
Prepared statement........................................... 324
Hollings, Hon. Ernest F., U.S. Senator from South Carolina,
questions submitted by......................................... 407
Humane Society of the United States, prepared statement.......... 562
Huntington's Disease Society of America, prepared statement...... 564
Hutchison, Hon. Kay Bailey, a U.S. Senator from Texas, questions
submitted by................................................... 408
Hyman, Hon. Steven E., M.D., Director, National Institute of
Mental Health, National Institutes of Health, Department of
Health and Human Services, prepared statement.................. 329
Immune Deficiency Foundation, prepared statement................. 565
Infectious Diseases Society of America's (IDSA), prepared
statement...................................................... 567
Joslin Diabetes Center, prepared statement....................... 571
Juvenile Diabetes Research Foundation International, prepared
statement...................................................... 573
Katz, Dr. Stephen I., Director, National Institute of Arthritis
and Musculoskeletal and Skin Diseases, National Institutes of
Health, Department of Health and Human Services................ 293
Prepared statement........................................... 332
Kennedy Krieger Institute, prepared statement.................... 574
Keusch, Gerald T., M.D., Director, John E. Fogarty International
Center for Advanced Study in the Health Sciences, National
Institutes of Health, Department of Health and Human Services,
prepared statement............................................. 334
Kirschstein, Hon. Ruth L., M.D., Acting Director, National
Institutes of Health, Department of Health and Human Services.. 293
Prepared statement........................................... 296
Summary statement............................................ 295
Klausner, Dr. Richard D., Director, National Cancer Institute,
National Institutes of Health, Department of Health and Human
Services....................................................... 293
Prepared statement........................................... 337
Landrieu, Hon. Mary L., U.S. Senator from Louisiana:
Opening statement............................................ 112
Questions submitted by....................................... 287
Lenfant, Dr. Claude, Director, National Heart, Lung and Blood
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 293
Prepared statement........................................... 340
Leshner, Alan I., Ph.D., Director, National Institute on Drug
Abuse, National Institutes of Health, Department of Health and
Human Services, prepared statement............................. 345
Lindberg, Dr. Donald A.B., Director, National Library of
Medicine, National Institutes of Health, Department of Health
and Human Services, prepared statement......................... 343
Lippy, Dr. William H., prepared statement........................ 681
Lovelace Respiratory Research Institute (LRRI), prepared
statement...................................................... 581
LPA, Inc., prepared statement.................................... 20
Lymphoma Research Foundation of America, Inc., prepared statement 582
Maddox, Dr. Yvonne T., Acting Deputy Director, Office of the
Director, National Institutes of Health, Department of Health
and Human Services, prepared statement......................... 348
McLaughlin, Dr. Jack A., Acting Director, National Eye Institute,
National Institutes of Health, Department of Health and Human
Services....................................................... 293
Prepared statement........................................... 351
McMullen, James, Deputy Assistant Secretary, Budget, Department
of
Labor.......................................................... 201
Medical Library Association, prepared statement.................. 588
Medicare Payment Advisory Commission, prepared statement......... 584
Miami Children's Hospital, prepared statement.................... 592
Mirer, Dr. Franklin E., director, Health and Safety, United Auto
Workers........................................................ 150
Prepared statement........................................... 151
Mississippi:
Department of Rehabilitation Services, prepared statement.... 594
State University, prepared statement......................... 523
Motion Picture & Television Fund, prepared statement............. 697
Murray, Hon. Patty, U.S. Senator from Washington, questions
submitted by................................................... 246
National:
AHEC Organization, prepared statement........................ 609
Alliance for Eye and Vision Research and the Foundation
Fighting Blindness, prepared statement..................... 597
Alliance to End Homelessness, prepared statement............. 595
Alopecia Areata Foundation, prepared statement............... 599
Association of Anorexia Nervosa and Associated Disorders,
prepared statement......................................... 602
Association of Children's Hospitals, prepared statement...... 603
Association of Developmental Disabilities Councils, prepared
statement.................................................. 606
Association of State Workforce Agencies, prepared statement.. 687
Center for Victims of Crime, prepared statement.............. 611
Coalition for Heart and Stroke Research, prepared statement.. 613
Down Syndrome Society, prepared statement.................... 622
Federation of Community Broadcasters, prepared statement..... 698
Fuel Funds Network, prepared statement....................... 614
Indian Child Welfare Association, prepared statement......... 616
Jewish Medical and Research Center, prepared statement....... 515
Latex Allergy Network, prepared statement.................... 620
Marfan Foundation, prepared statement........................ 626
Medical Association, prepared statement...................... 628
Military Family Association, Inc., prepared statement........ 432
Minority Public Broadcasting Consortia, prepared statement... 700
MPS Society Inc., prepared statement......................... 631
Multiple Sclerosis Society, prepared statement............... 632
Neurofibromatosis Foundation, Inc., prepared statement....... 636
Organization for Rare Disorders, prepared statement.......... 637
Psoriasis Foundation, prepared statement..................... 641
Public Radio, prepared statement............................. 701
Sleep Foundation, prepared statement......................... 642
Task Force to End Sexual and Domestic Violence Against Women,
prepared statement......................................... 668
Treasury Employees Union, prepared statement................. 690
NephCure Foundation, prepared statement.......................... 645
New York University, prepared statement.......................... 646
Nowell, Jacqueline, director, Safety and Health, United Food and
Commercial Workers International Union......................... 189
Prepared statement........................................... 190
Nyeholt, James and Margaret, prepared statement.................. 649
O'Connor, Dr. Christina, prepared statement...................... 650
Olden, Hon. Kenneth, Director, National Institute of
Environmental Health Sciences, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 353
Paige, Dr. Roderick R., Secretary of Education, Office of the
Secretary, Department of Education............................. 251
Prepared statement........................................... 262
Summary statement............................................ 255
Pancreatic Cancer Action Network, Inc., prepared statement....... 652
Penn, Dr. Audrey S., Acting Director, National Institute of
Neurological Disorders and Stroke, National Institutes of
Health, Department of Health and Human Services................ 293
Prepared statement........................................... 356
People for the Ethical Treatment of Animals, prepared statement.. 653
Population Association of America and the Association of
Population Centers, prepared statement......................... 656
Pulmonary Hypertension Association, prepared statement........... 659
Punnett, Dr. Laura, professor, Department of Work Environment,
University of Massachusetts Lowell............................. 139
Prepared statement........................................... 141
Reid, Hon. Harry, U.S. Senator from Nevada:
Prepared statement........................................... 266
Questions submitted by......................................63, 287
Research Society on Alcoholism, prepared statement............... 661
Rhinehart, Lynn, American Federation of Labor-Congress of
Industrial Organizations....................................... 3
Prepared statement........................................... 22
Rotary International, prepared statement......................... 663
Ruffin, John, Ph.D., Director, National Center on Minority Health
and Health Disparities, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 359
Scleroderma Research Foundation, prepared statement.............. 667
Seminario, Peg, director, Department of Occupational Safety and
Health, AFL-CIO...............................................88, 197
Prepared statement........................................... 89
Sjogren's Syndrome Foundation, prepared statement................ 669
Skelly, Thomas P., Director, Budget Service, Department of
Education...................................................... 251
Sparlin, Dean, Esq., Gibson, Dunn & Crutcher, LLP................ 165
Prepared statement........................................... 167
Specter, Hon. Arlen, U.S. Senator from Pennsylvania:
Opening statements.........................1, 27, 65, 201, 251, 293
Questions submitted by............................54, 229, 280, 394
Spiegel, Dr. Allen M., National Institute of Diabetes and
Digestive and Kidney Diseases, National Institutes of Health,
Department of Health and Human Services........................ 293
Prepared statement........................................... 364
Stevens, Hon. Ted, U.S. Senator from Alaska:
Opening statement............................................ 30
Questions submitted by.................................58, 245, 401
Straus, Stephen E., M.D., Director, National Center for
Complementary and Alternative Medicine, National Institutes of
Health, Department of Health and Human Services, prepared
statement...................................................... 362
Sudden Infant Death Syndrome Alliance, prepared statement........ 672
Tabak, Lawrence A., Director, National Institute of Dental and
Craniofacial Research, National Institutes of Health,
Department of Health and Human Services, prepared statement.... 367
The Mended Hearts, Inc., prepared statement...................... 590
Thompson, Hon. Tommy G., Secretary, Office of the Secretary,
Department of Health and Human Services........................ 27
Prepared statement........................................... 32
Summary statement............................................ 31
Trust for America's Health, prepared statement................... 674
U.S. Senators and House Members, copy of letter sent to.......... 25
United:
Fresh Fruit & Vegetable Association, prepared statement...... 677
Tribes Technical College, prepared statement................. 435
University of:
Cincinnati, prepared statement............................... 448
Medicine and Dentistry of New Jersey, prepared statement..... 678
Miami, Coral Gables, Florida, prepared statement............. 682
Tulsa, prepared statement.................................... 438
Vaitukaitis, Dr. Judith L., Director, National Center for
Research Resources, National Institutes of Health, Department
of Health and Human Services, prepared statement............... 371
Whitescarver, Jack, Ph.D., Acting Director, Office of AIDS
Research, National Institutes of Health, Department of Health
and Human Services, prepared statement......................... 374
Wood, Jerri, legislative chairman, Local 7800, Communication
Workers of America............................................. 192
Prepared statement........................................... 194
Woodward, Joseph M., Associate Solicitor of Labor, Occupational
Safety and Health Administration, Department of Labor.......... 3, 68
SUBJECT INDEX
----------
ERGONOMICS
Page
Application of ergonomics, what are the tangible benefits to?.... 172
Approach......................................................... 120
Congress, questions posed by, answers to......................... 130
Congressional Review Act to rescind ergonomics regulation, AHCA
praises use of................................................. 25
Considerations, additional....................................... 129
CRA, Department activities since................................. 71
Credentials and qualifications................................... 170
Data collection and reporting systems, the need for.............. 122
Dimensions of the problem........................................ 121
Dissent.......................................................... 122
Panel response to............................................ 134
Does ergonomics work?............................................ 171
Epidemiologic evidence since 1997................................ 143
Epidemiology, summary of......................................... 147
Ergonomic:
Interventions, the effectiveness of.......................... 104
Programs are technically feasible and are cost-effective,
actual industrial experience shows that.................... 177
Sues in the health care workplace, addressing................ 184
Standard, adequate scientific and clinical basis exists to
support.................................................... 100
Standard, refutation of some common arguments against........ 106
Trends in applied............................................ 173
Why failed................................................... 71
Evidence, patterns of............................................ 126
Exposure--response relationships................................. 145
Impetus.......................................................... 120
Industry misrepresentations about costs, history of.............. 180
Injuries, cost of................................................ 181
Literature reviews............................................... 145
Musculoskeletal disorders:
Epidemiology in 1997, NIOSH review of........................ 142
The importance of early recognition and appropriate treatment
of......................................................... 101
And the workplace--low back and upper extremities............ 123
The toll of, on workers and the economy is great............. 91
OSHA ergonomics standard:
National Academy of Sciences/Institute of Medicine report
supports................................................... 22
Needed to protect workers from musculoskeletal disorders..... 93
Panel:
Charge, composition, and approach............................ 125
Composition.................................................. 120
Principles....................................................... 72
Psychosocial factors and MSDs.................................... 146
Recommendations.................................................. 128
Research agenda.................................................. 122
Scientific evidence in support of an ergonomics standard is
extensive and strong........................................... 92
Timeline......................................................... 70
Truth, the first casualty of war is the.......................... 177
What's next?..................................................... 73
Work factors and musculoskeletal disorders, relationship among... 121
Work-related musculoskeletal disorders are the Nation's leading
job safety problem............................................. 90
Workplace interventions, the value of............................ 121
DEPARTMENT OF EDUCATION
Office of the Secretary
Achievement:
Creating a culture of........................................ 258
Gap, closing the............................................. 263
Additional committee questions................................... 280
American history instruction support............................. 289
Annual testing, cost of.......................................... 279
Campus crime..................................................... 275
Choices, empowering parents with................................. 264
Clery Act implementation......................................... 281
College:
Education, access to a....................................... 284
Persistence in............................................... 283
Population, growth in........................................ 283
Community Learning Centers, 21st Century......................... 282
Debate reform and principles of reform, not budget............... 260
Dropout problem, addressing the.................................. 287
Education 302(b) congressional budget allocation................. 254
Education budget:
Issues....................................................... 251
Strategic review of.......................................... 253
Education change:
Guiding principles of........................................ 259
Principles of................................................ 260
Elementary and secondary proposals, other key.................... 265
Elementary School Counseling Demonstration Program............... 284
ESEA:
Reauthorization.............................................. 259
Spending and 4th grade math achievement...................... 257
Reading achievement...................................... 257
Excellence:
Education must be nationwide................................. 255
Requires change.............................................. 255
Expanding flexibility and reducing bureaucracy................... 264
Failing schools--cumulative effect of achievement gaps........... 260
Federal:
ESEA investment and student achievement...................... 258
Role and school construction................................. 267
Fellowships, GAANN and Javits.................................... 286
Funding:
Class-size reduction......................................... 290
For special education and IDEA reauthorization............... 277
School construction........................................267, 269
Renovation............................................... 253
Special education............................................ 252
Higher education, unmet need and access to....................... 282
Houston:
Independent school system.................................... 259
School system reforms and public opinion..................... 262
Impact aid construction.......................................... 271
Leveraging Federal funds--school construction in Iowa............ 270
Math and science budget support.................................. 285
NAEP testing results--4th grade reading scores................... 255
Pell Grant Program costs......................................... 289
Postsecondary education.......................................... 265
President's proposal and use of school construction funds........ 277
Reading performance, flat........................................ 256
Reform and results, budget increases to be tied to............... 275
Reform, education funds for...................................... 281
School renovation grants--guidance for implementation............ 281
Shortages, special education teacher............................. 284
Tax cut package and education funding............................ 253
Teacher:
Fund and class size reduction, flexible...................... 268
Retention and recruitment grants............................. 288
Teaching:
American History Grant Program............................... 290
Transition to................................................ 288
Testing and accountability....................................... 279
Title I:
Allocations--use of updated data............................. 291
Budget request............................................... 287
Hold-harmless................................................ 291
``Shortfall''................................................ 291
State Grants Program, Assistive Technology Act............... 285
TRIO programs..................................................283, 289
Vocational education programs support............................ 286
Vouchers:
Private school............................................... 280
School choice................................................ 274
Youth violence................................................... 280
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Additional committee questions................................... 393
Adolescents:
Factors influencing obesity in............................... 322
Reducing HIV and AIDS among.................................. 301
Adult stem cell experiment....................................... 381
Aging, biology of................................................ 326
AIDS:
Comprehensive research plan and budget....................... 375
Research, Office of.......................................... 349
Alcohol:
Is unique.................................................... 318
Research, advances in........................................ 319
Alcoholism, neuroscience holds the key to behaviors of........... 319
Alzheimer's disease:
Conquering................................................... 324
Patients, improving daily living for......................... 321
Research..................................................... 383
Autism research.................................................. 301
Basic science, beyond............................................ 320
Behavior......................................................... 342
Bioengineering, bioimaging, and bioinformatics................... 372
Biomedical research infrastructure............................... 405
Bone biology and bone diseases................................... 333
Botanicals....................................................... 363
Budget summary, fiscal year 2002................................. 318
Budgetary increases.............................................. 415
CAM interventions, mechanisms of................................. 362
Canavan's research............................................... 401
Cancer........................................................... 363
Trends....................................................... 337
Capacity building programs, other................................ 361
Centers of Excellence Program.................................... 361
Children:
Research in.................................................. 332
To grow, improving the environment for....................... 301
Cholesterol guidelines, new...................................... 397
Chronic:
Infectious diseases: Dental caries and periodontal diseases.. 369
Pain and temporomandibular disorders, new methods needed to
treat...................................................... 370
Clinical Research Career Development programs.................... 400
Clinical:
Research: Taking basic discoveries into medical practice..... 298
Trials, including child mental disorder studies.............. 331
Congenital cardiovascular malformations.......................... 340
Diabetes......................................................... 365
Diagnosis........................................................ 338
Disease:
And disability, reducing..................................... 325
New preventive strategies against............................ 372
Drug:
Abuse prevention, science-based principles for............... 347
Problems, responding to ever-emerging new.................... 346
Embryonic stem cell potential.................................... 382
End-of-life/palliative care research............................. 322
End-stage renal disease and polycystic kidney disease............ 367
Environmental susceptibility genes, search for................... 355
Ethical, legal, and social implications.......................... 311
External influences.............................................. 342
Fundamental question, new technology to help answer a............ 300
Funding collaboration............................................ 408
Gene:
And the environment.......................................... 354
Expression................................................... 309
Generation of researchers, developing a new...................... 313
Genetic:
And genomics................................................. 341
Research is key to understanding craniofacial disorders...... 369
Variability, exposure, and disease association............... 355
Genome sequences of non-human species............................ 308
Genomic:
And genetic medicine.......................................297, 371
Science, centers of excellence in............................ 310
Global health:
Challenges in................................................ 335
Emerging infectious diseases................................. 314
Government Performance and Results Act.....318, 321, 343, 348, 353, 370
Grant submissions:
Quality of science in........................................ 415
Success rate for............................................. 415
Health:
And disease, understanding................................... 341
Disease and stroke, trans-agency conference..................
Disparities.................................298, 307, 332, 364, 373
Education and communication.................................. 353
Information dissemination.................................... 361on
395
Hepatitis C and other chronic liver diseases..................... 366
HIV infection, investigating the oral cavity's contribution to
defending the body against..................................... 370
HIV/AIDS......................................................... 314
Human:
Genetic variation............................................ 309
Genome sequence, finishing the............................... 308
Immune-mediated diseases......................................... 315
Inflammatory bowel disease and other digestive diseases.......... 367
Information dissemination........................................ 416
Infrastructure and enabling technologies......................... 298
Initiatives:
Fiscal year 2002............................................. 336
New and expanded............................................. 322
Integrative medicine and research training....................... 364
International collaborations by institutes....................... 409
Investments, return on........................................... 398
Islet:
Inadequate supply of......................................... 384
Transplants in type 1 diabetes............................... 384
John Edward Porter Neuroscience Research Center.................. 331
Learning, behavioral interventions to improve.................... 301
Loan Repayment Program........................................... 361
Low vision....................................................... 407
Mandate, broadening the.......................................... 344
Mental:
And general medical disorders, co-occurring.................. 329
Disorder phenotypes, animal models can provide............... 330
Disorders are enormously disabling........................... 329
Illness research, molecular genetics tools benefit........... 330
Meritorious research............................................. 400
Molecular targets: A new era in the discovery and development of
preventive and therapeutic agents for cancer................... 338
Mood disorders, strategic research planning targets.............. 329
Muscle biology and muscle diseases............................... 333
National drug abuse treatment clinical trials network............ 346
NCCAM success rate............................................... 406
NDRI expansion................................................... 394
Neurological:
Diseases, progress and promise in............................ 357
Disorders, the burden of..................................... 356
Neuroscience portfolio sets stage for new treatments............. 347
NIAID, overview of............................................... 313
NIBIB, new technologies in....................................... 399
NIDA'S comprehensive portfolio................................... 345
NIH institutes and centers, leveraging resources with the........ 359
NINDS stroke strategic plan...................................... 394
Nursing research, building the capacity to do.................... 323
OD activities, other............................................. 350
Pancreatic cancer................................................ 404
Pandemic, the exploding.......................................... 374
Population morbidity and mortality rates......................... 398
Practice at the community level, translating research findings
into........................................................... 321
President's request, amount of................................... 343
Prion:
NIH support of............................................... 404
Research..................................................... 404
Priority:
Basic science................................................ 376
International research....................................... 376
Prevention research.......................................... 375
Racial and ethnic minorities................................. 376
Treatment research........................................... 376
Vaccine research............................................. 375
Promise, mission of.............................................. 312
Protein structure, function, and interaction..................... 310
Public health and public safety approaches, blending............. 348
Quality of life for all Americans, reducing oral health
disparities to improve......................................... 368
Research:
Behavioral and social........................................ 326
Capacity..................................................... 373
Cataract..................................................... 352
Corneal disease.............................................. 351
Creates new materials for replacing and restoring damaged
tissues.................................................... 369
Directions, identifying productive new....................... 312
Early detection.............................................. 338
Endowment Program............................................ 361
Glaucoma..................................................... 352
Grant portfolio, an independent.............................. 360
Initiatives, recent.......................................... 306
Mission, role in the......................................... 316
Project grants............................................... 399
Retinal disease.............................................. 351
Strabismus, amblyopia, and visual processing................. 352
Training..................................................... 306
Training and career development.............................. 373
Retinal degenerative diseases.................................... 407
Science:
Advances..................................................... 344
Leads our national discourse................................. 348
Sickle cell disease.............................................. 340
SIDS, new collaborations to eliminate racial disparities in...... 300
Skin biology and skin diseases................................... 333
Stem cell........................................................ 400
Funding...................................................... 405
In vision research, use of................................... 385
Research..................................................... 384
The Office of:
Behavioral and Social Sciences Research...................... 349
Disease Prevention........................................... 350
Research on Women's Health................................... 349
Toxicity/carcinogenicity, assessment of.......................... 354
Treatments and prevention, promise for new....................... 310
United States, the evolving epidemic in the...................... 374
Urologic diseases................................................ 367
Vaccine development.............................................. 316
Variant.......................................................... 401
vCJD:
And prion infected beef...................................... 404
On the rise?................................................. 402
Research, role of NIH in..................................... 402
Viral similarities............................................... 403
Visual impairment and its rehabilitation......................... 352
What is NINDS doing to move toward cures?........................ 358
Women's health................................................... 302
Office of the Secretary
27
Additional committee questions................................... 54
Alternative medicines............................................ 48
America's children and families, increasing support for.......... 33
Budget proposal, President's fiscal year 2002.................... 60
Center for Mental Health Services................................ 60
Child care.......................................................43, 46
Development block grant...................................... 57
Child support reform............................................. 52
Children with mental retardation, special health needs of........ 58
Chronic disease tracking system.................................. 63
Community:
Attendant services and supports.............................. 62
Health centers...............................................56, 61
Disease control prevention, centers for.......................... 39
Faith-based initiatives..........................................48, 54
Family planning.................................................. 51
Federal mental health funding.................................... 59
Foster care......................................................45, 47
Head Start....................................................... 57
Health care...................................................... 44
Infrastructure and reforming management, investing in............ 36
Medicaid program................................................. 50
Medicare and expanding access to quality health care, improving.. 35
National Health Service Corps.................................... 61
Nursing:
Home initiative.............................................. 53
Shortage.....................................................42, 46
Nutrition programs............................................... 50
Obesity rates.................................................... 49
Real Choice Systems Change grants................................ 62
Ryan White programs.............................................. 57
SCHIP............................................................ 44
Scientific and health care quality research, enhancing........... 34
Stem cell research............................................... 40
Strong and healthy America, working together to build a.......... 39
Tobacco, regulation of, by FDA................................... 41
Advertisements............................................... 41
Youth violence...................................................47, 57
DEPARTMENT OF LABOR
Office of the Secretary
Additional committee questions................................... 229
Advance appropriation............................................ 208
Asbestos, exposure of miners to, in Libby, Montana............... 246
Bureau of International Labor Affairs (ILAB)..................... 240
Caregivers, shortage of.......................................... 248
Companionship services........................................... 229
Coordination, one-stop........................................... 233
Disability employment policy..................................... 207
Employment and training programs................................. 206
Energy Employees Occupational Illness Compensation Program Act
(EEOICPA)...............................................208, 238, 247
ERGO II.......................................................... 244
Fair Labor Standards Act (FLSA).................................. 242
Federal Employees' Compensation Act surcharge.................... 209
Funding level, fiscal year 2002.................................. 234
Government Performance and Results Act........................... 209
Grant accountability............................................. 209
Harwood grants................................................... 230
Health care professionals, immigration of........................ 249
Information technology........................................... 208
Cross-cut budget............................................. 231
Injuries, underreporting of...................................... 243
International labor affairs...................................... 208
Labor statistics................................................. 208
Long-term care givers, legislation for........................... 249
Mass layoffs..................................................... 246
Migrant and Seasonal Farmworker Housing Program.................. 249
Office of the 21st Century Workforce............................. 230
OSHA:
Enforcement budget........................................... 244
Ergonomists.................................................. 243
MSHA and ESA staff reductions................................ 231
Standards.................................................... 244
Pension and Welfare Benefits Administration...................... 241
Pension distributions, lump sum.................................. 242
Personal protective equipment.................................... 241
Staffing shortages............................................... 240
The Treasury, funds reverting to................................. 235
Trade Adjustment Assistance (TAA)/North American Free Trade
Agreement-Transitional Adjustment Assistance (NAFTA-TAA)....... 209
Training needs, State flexibility for............................ 235
Transitional Living Program...................................... 230
Unemployment insurance........................................... 208
Unspent funds listed by State and by grant....................... 235
Veterans' Employment and Training Service........................ 208
WIA budget request reductions.................................... 245
Disparity in................................................. 241
Women's Bureau equal pay......................................... 247
Worker layoffs................................................... 233
Worker protection/compliance assistance.......................... 207
Workforce programs, cuts in...................................... 232
Youth programs................................................... 248
Additional funding........................................... 234