[Senate Hearing 108-745]
[From the U.S. Government Publishing Office]
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005
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THURSDAY, MARCH 25, 2004
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:35 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, Stevens, and Harkin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
STATEMENT OF HON. TOMMY G. THOMPSON, SECRETARY
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee for Labor, Health, Human Services,
and Education will now proceed.
Our witness today is the distinguished Secretary of Health
and Human Services, Tommy Thompson. Secretary Thompson served
as Governor of Wisconsin from 1987 to the year 2000, the
longest tenure of a Governor in Wisconsin's State history, a
national leader in welfare reform and expanding healthcare to
low-income children and families, served as chairman of the
National Governors Association, the Education Commission of the
States, and Midwestern Governors Conference, bachelor of law
degree from the University of Wisconsin in Madison.
We focus today on the budget of the Department of Health
and Human Services, which has been proposed by the
administration at $62.9 billion, which is an increase of $974
million over the fiscal year 2004 level, or 1.6 percent. And
this is tough year on all accounts, as we know. This budget
proposal has a great many question marks in it, one of which is
the assumed savings of $767 million, all of which are within
the jurisdiction of Finance Committee, but I'm sure Senator
Thompson will drop a letter to the Finance Committee and tell
them to proceed to save that money for us, right, Secretary?
Secretary Thompson. That is correct, sir.
Senator Specter. And the reduction and elimination of about
a dozen programs, which have a lot of support in the Congress--
Article 1 of the Constitution still has that cumbersome
provision about congressional authority to appropriate, and
some of our colleagues take that very seriously on programs
which have been developed over the years. And I take a look at
11 programs which are being zeroed out, and then major cuts.
The Center for Disease Control has a reduction of $116
million, which is a little hard to understand in light of their
increased responsibilities. Every time we turn around, there's
a major problem on SARS or AIDS or bioterrorist threats. And
their building program is in midstream. I visited the Center
for Disease Control several years ago, and was shocked to see
what was going on down there. Your predecessor, Mr. Secretary,
appeared here every year, and never once mentioned the need for
capital improvements at the CDC, and it was in dire need. It's
gone a fair distance on a billion-and-a-half dollar budget, and
I don't know how we can stop it now, but, at the same time, I
don't know how we can not stop it now.
The NIH funding is totally inadequate to allow NIH to go
forward. I know how important that is in your personal agenda.
And I also know you're not the President or the director of
OMB, and you don't structure all of the budgets.
But it looks like a tough year ahead for us, Mr. Secretary.
Secretary Thompson. It is.
Senator Specter. I was hoping to finish before the
distinguished ranking member came, so he missed his opening
statement.
Just kidding. Just kidding, Senator Harkin.
We have established a unique partnership, I think, that the
world knows about, to the detriment of both of us, personally.
But when we have changed gavels from time to time, it has been
seamless, and we have worked very, very closely together. And
I'm delighted to yield to my distinguished colleague today, who
has effectively tied up the Senate with an overtime issue on
which I agree with his position.
Senator Harkin.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. I wish it wouldn't tie up the Senate. I
wish we would just vote, that would be the end of it.
Thank you very much----
Senator Specter. We--Senator Frist may let you do that.
Then what are you going to do?
Senator Harkin. We vote, and then we move on.
Thank you very much, Mr. Chairman. And, again, I just echo
the words that you've said. I've enjoyed our partnership, now
going back 14 years, and the changing of the gavel back and
forth has been seamless. And I have appreciated your
willingness to work together and make this truly a bipartisan
subcommittee, in every sense of the word. The issues we deal
with, on health and education, medical research, biomedical
research, are not really partisan issues at all, and I don't
think either one of us have ever looked at them in that regard.
Mr. Secretary, it's always a pleasure to have you appear
before this subcommittee, and I look forward to working with
you in this year's budget process. First, I want to commend you
for your commitment to two important issues, issues that I know
are a top priority for both of us.
The first is the support for programs for persons with
disabilities. I appreciate your continued support for the New
Freedom Initiative and its goal of removing barriers to
community living for people with disabilities. This is
extremely important. Now let's work together to get the
legislation enacted.
Secretary Thompson. Please.
Senator Harkin. I also want to thank you for including
funding for the Real Choice System Change Grants in your fiscal
year 2005 budget. I don't think those funds would be there
without your personal intervention, and I appreciate that.
Second, I congratulate you on your efforts to make wellness
programs a priority. Obesity, lack of physical activity,
smoking, and poor nutrition are a grave threat to our country;
not just to individuals, but to all of us, as taxpayers. In
this country, we spend a trillion dollars a year on healthcare,
and the figures show that fully 75 percent of those are spent
on chronic diseases, like heart disease, cancer, and diabetes.
And what those diseases have in common is that often they're
preventable.
So, Mr. Secretary, I know you agree, because I've read your
statements. In this country, we fail to make the necessary up-
front investments in prevention. I'm absolutely convinced that
prevention is an idea whose time has come. And the good news
is, this can be and should be a bipartisan initiative. Senator
Specter and I are working together on some wellness initiatives
that we plan to include in this year's bill. I look forward to
working with you on these initiatives.
For one thing, CDC has promised to send me some more
pedometers. Ah-ha, you beat me to it. All right, Mr. Secretary,
tell you what I'll do. Unscripted, I tell you what, I may issue
a challenge, and I'll issue one to my partner here. We'll all
put pedometers on, and we'll see who takes the most steps this
year.
Secretary Thompson. Ten-thousand steps a day, Senator.
Senator Harkin. How many?
Secretary Thompson. Ten-thousand steps a day.
Senator Harkin. Are you doing that?
Secretary Thompson. Uh-huh.
Senator Harkin. I may take back my challenge.
Good for you. Well, that is a great example, because that's
what we've got to be doing here.
We're doing some other things. I've been working with
Senator Frist on getting some signs put by the elevators----
Secretary Thompson. Uh-huh.
Senator Harkin [continuing]. Which they've done at NIH. I
don't know if you've done your Department the same. If we just
go over there a little bit, there's a stairs. If you climb the
stairs, it's healthier, and there's a certain calorie type of
thing for how many stairs you climb, and stuff like that, to
get people climbing stairs. Well, that's just off the record.
But we're going to get the pedometers, and we're going to
try to get this thing moving here on the Hill. But, again, I
just wanted to commend you for those things. The Freedom Grants
Initiative, the money that you've requested for the Systems
Change Grants--please work with us to get that bill through,
the New Freedom Initiative. It's most important. And on all the
stuff you're doing on wellness and obesity and things like
that--I may differ with you slightly--I have this in my
questions--in terms of whether or not it should be mandatory or
permissive for restaurants and things like that, on the menus
and stuff, and we'll have a dialogue with you on the questions
on that.
The one last thing that--on a less positive note, I
suppose--I'm concerned about recent reports that the chief
actuary for the Medicare program was told not to tell Members
of Congress that his office had concluded that the Medicare
Prescription Drug Program--that would cost upwards of $10
billion more than previously reported. Again, I'll be asking
you this during the question-and-answer period.
Again, Mr. Secretary, I look forward to your testimony.
Secretary Thompson. Thank you very much.
Senator Specter. Thank you very much, Senator Harkin.
Senator Cochran.
OPENING STATEMENT OF SENATOR THAD COCHRAN
Senator Cochran. Mr. Chairman, thank you very much.
Mr. Secretary, we appreciate very much your exemplary
service as Secretary of the Department of Health and Human
Services. We also note that you've made strong efforts to begin
the implementation of the new Medicare Prescription Drug
Initiative. I'm pleased to see, also, the aggressive effort in
the budget to safeguard the country against bioterrorist
threats--$5 million that's included in the budget to help
prepare State and local governments to respond to these disease
outbreaks is an important step forward.
I also commend the efforts to identify threats before they
reach our country, and to prevent the entry of microbes,
diseases, adulterated drug products, and all other items that
would threaten the safety of our citizens. The budget also
provides funding to help improve the health of those who live
in small towns and rural communities, such as in my State of
Mississippi. Almost half of those served by small-town health
centers are in rural areas. The increase of $219 million to
provide for health centers and their sustainment was
appreciated very much.
It's my hope that special emphasis can also be placed on
targeting research to areas of the country that suffer
disproportionately from diseases like diabetes, cardiovascular
disease, and obesity. Generally speaking, I think, under the
pressures of trying to control spending and deal with the
problems of the deficit, this is a budget that should encourage
those of us who are interested in improving the health and
safety of American citizens.
Thank you very much.
Secretary Thompson. Thank you, Senator.
Senator Specter. Thank you, Senator Cochran.
Just one note, to answer the question which may be on the
minds of many, or at least some, about my Halloween mask. I
came out of the restaurant in Philadelphia on Saturday night
and tripped on a defect in the sidewalk, and landed squarely on
my nose. And I'm pleased to report that my nose was not broken,
but where my nose hit the sidewalk, the sidewalk was broken.
Mr. Secretary, the floor is yours.
Secretary Thompson. Mr. Chairman, Senator Harkin, Senator
Cochran, thank you very much.
I am very happy that the nose was not broken, and I'm glad
that you are mending back in good shape. That could have been a
very serious fall, and I'm very happy and appreciative that
things are----
Senator Specter. Mr. Secretary, my colleague in the
Philadelphia city race, Tom Gola, a famous basketball star,
lost his balance, slipped and hit his head, and he's been in
very serious condition ever since, so there are repeated
circumstances of people falling, and even fatalities, so I
consider myself very fortunate.
Having brought up the subject, I'm reminded there's a
famous story, probably apocryphal, about Winston Churchill
laying on a veranda one night, and a woman walked by and saw
his condition and said, ``You're drunk.'' And he responded,
``You're ugly.''
She recounted again, ``You're drunk.'' And he said,
``You're ugly.'' And then she said again, ``You're drunk.'' And
he said, ``Yes, but I'll be sober in the morning.''
Next week, I'll be back to my old appearance, however bad
that may be.
SUMMARY STATEMENT OF HON. TOMMY G. THOMPSON
Secretary Thompson. I want to thank you, Senator Specter,
for inviting me, and Senator Harkin, for giving me this
opportunity to discuss the President's fiscal year 2005 budget
for the Department of Health and Human Services.
In my first 3 years in the Department, I believe we have
made tremendous progress in improving the health, the safety,
and the independence of the American people. We continue to
advance in providing healthcare to seniors and to low-income
Americans, and in providing the welfare to children and
strengthening families and protecting the homeland. We have re-
energized the fight against AIDS at home and abroad. We've
increased access to quality healthcare, especially for
minorities, the uninsured, and the under-insured.
We're helping smokers--and I know this is a very big
concern of yours, Senator Harkin--free themselves of a
debilitating habit through a national hotline. We have set it
up in the Department, Senator Harkin, without asking the
Congress for any money. It'll be up and running by the end of
this year. And I want you to know that I pushed this, and I
feel as passionate as you do that we've got to reduce the
tobacco. And hopefully someday we'll be regulating it.
With your help, 3 months ago President Bush signed the most
comprehensive Medicare improvements since it was created,
nearly four decades ago. There has been some controversy, and I
know there'll be questions about it, and I'm going to answer
those questions completely to this particular Committee.
To expand on our achievements, the President proposes $580
billion for HHS for fiscal year 2005, an increase of $32
billion, or 6 percent, over fiscal year 2004. Our discretionary
budget authority is $67 billion, an increase of $819 million,
or 1.2 percent, over fiscal year 2004, and an increase of 26
percent since 2001. And I understand, Senator Specter, that
there are some gaps, and I want to work with you to see how we
might be able to ameliorate the situation.
Of this total, subcommittee is responsible for $63 billion,
an increase of $659 million, or 1.1 percent, over fiscal year
2004, or $974 million under current law. In order to strengthen
our bioterrorism preparedness and public-health system, we have
requested $4.1 billion, up from $300 million in 2001. And I
would respectfully--humbly respect--and invite all of you
Senators down to take a look at what we have done in the
Department. And I think you'll find it very impressive and
informative, what we have built, to be able to track diseases
and bioterrorism activities all over the world. I've had a lot
of people come down, and everybody that walks out of it feels
very much relieved that we are very much there. And I would
hope that you'd come down and see it.
This investment will improve our preparedness for
bioterrorism attack on any kind of bioterrorism attack or for
any public-health emergency. We already have seen our
investment pay off, in CDC's leadership in fighting the SARS
outbreak last year in a coordinated a public-health response to
the West Nile virus, and even helped to deal with a
particularly hard flu season this past year.
As you all know, I'm a very big proponent of information
technology. That's why we will be providing a computer
language, called SNOMED, to any proprietor that wants to, at no
charge, starting, hopefully, by the 1st of May. We're leading
the way in developing standards for electronic medical records.
And last month, I announced an FDA rule to prevent medication
errors by requiring bar codes on medicine and blood products.
Community health centers, as you have mentioned, Senator
Cochran, are absolutely a key element for increasing access to
and availability of healthcare for helping the uninsured. We're
proposing to provide $1.8 billion for health centers to provide
healthcare services to 15 million Americans. I want to thank
you, Senator Specter and Senator Harkin, for your leadership on
this. We wouldn't be here today if it wouldn't have been for
your great leadership.
Through our New Freedom Initiative, Senator Harkin, we're
working to help the elderly, the disabled, by promoting home
and community-based centers. In my desire to reduce obesity and
diabetes, we, along with the help of Congress last September,
my Department announced 12 steps to HealthierUS grants totally
more than $13 million to some more community initiatives to
promote better health and prevent disease. This included 23
communities, including one tribal organization, 15 small cities
and rural communities, and seven large cities. These
communities are doing some very exciting work in chronic
disease prevention and health promotion. For example, in
Washington State, health professionals are targeting Latino
adults who have diabetes, asthma, or obesity, or have a high
risk of getting those conditions.
In Michigan, through the Intertribal Council of Michigan,
public-health officials have created a resurgence of interest
in passing on traditional wisdom in cultural practices,
including consumption of highly nutritious traditional foods.
We're delighted by these activities, and the Department will
expand the program this year with the addition of $44 billion,
and has requested $125 million for these programs in 2005.
Later today, I'm going to unveil the Medicare improved
drug-discount cards. I will also announce that a Pennsylvania
company will be among our Medicare-approved drug-discount card
sponsors. This company serves 265,000 Pennsylvania seniors,
and, all together, Pennsylvania seniors will receive $486
million this year and next.
PREPARED STATEMENT
We look forward, ladies and gentlemen, to working with this
committee, the medical community, and all Americans as we build
upon our past accomplishments, implement the new Medicare law,
and carry out the initiatives that President Bush is proposing
to build a healthier, safer, and stronger America. And I want
to thank you for your bipartisan support on health issues.
Thank you, once again, for giving me this opportunity to
appear in front of you.
[The statement follows:]
Prepared Statement of Hon. Tommy G. Thompson
Good morning, Chairman Specter and members of the Subcommittee. I
am pleased to present to you the President's fiscal year 2005 budget
for the Department of Health and Human Services (HHS). I am confident
you will find our budget to be a positive solution to improving the
health, safety, and well-being of our Nation's citizens. Before I
discuss the fiscal year 2005 budget, I would like to thank the
Subcommittee for its hard work and dedication to the programs within
HHS. I am extremely proud of the manner in which we have worked
together effectively, in a bipartisan effort, since I was appointed
Secretary. This cooperation should be lauded and the tremendous results
for the American people can be seen in our many accomplishments.
This year's budget proposal builds upon past accomplishments in
meeting several of the health and social well-being goals established
at the beginning of the current Administration. I deeply appreciate the
level of support I have received from the Subcommittee during the past
on so many issues that have touched American's lives. For example, with
your help, the Department has funded 614 new and expanded health
centers. This has effectively increased access to health care for an
additional 3 million people, of which 64 percent are minorities,
increasing the overall number of patients served in health centers by
almost 30 percent. In the past three years, your support for protecting
our nation from bioterrorism has made the country better prepared and
better protected.
Your unwavering commitment in doubling the budget for the National
Institutes of Health has supported work by more than 217,000 research
personnel affiliated with 2,000 universities, hospitals, and other
research facilities across our great nation. This support has led to a
constant flow of new scientific discoveries. We have also established
the Access to Recovery State Vouchers program, providing 50,000
individuals with needed substance abuse treatment and recovery
services. HHS initiated a new Mentoring Children of Prisoners program
to provide one-to-one mentoring for approximately 30,000 children with
an incarcerated parent and created education and training vouchers for
foster care youth, securing funding to provide vouchers of up to $5,000
to 17,400 eligible youth since 2001. Last year, we worked together with
Congress to pass the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), adding prescription drug coverage for
seniors and modernizing the Medicare program. While I thank you for
your support in these and the many other accomplishments to improve the
health, safety, and well-being of our citizens, there is still much to
be done.
For fiscal year 2005, the President proposes an HHS budget of $580
billion in outlays to enable the Department to continue working with
our State and local government partners, as well as with the private
and volunteer sectors, to ensure the health, safety, and well-being of
our nation. This proposal is a $32 billion increase in outlays over the
comparable fiscal year 2004 budget, or an increase of about 6 percent.
The mandatory programs in the HHS budget total $513 billion in outlays.
Of this $513 billion, Medicare and Medicaid combine to equal about $474
billion, an increase of approximately $29 billion or 6.5 percent over
fiscal year 2004. The discretionary programs in the HHS budget totals
$67 billion in budget authority. Of this total, this Subcommittee is
responsible for approximately $63 billion in budget authority, an
increase of approximately $659 million, or 1.1 percent over fiscal year
2004 for proposed law, and an increase of approximately $974 million,
or 1.6 percent over fiscal year 2004 for current law.
For fiscal years 2004 and 2005, the MMA appropriated $1.0 billion
in start-up funds so that the Centers for Medicare and Medicaid
Services (CMS) would have funds available upon enactment to implement
the enormous increase in new administrative responsibilities under the
legislation. With rare exceptions, however, these administrative costs
have typically been categorized in the budget as discretionary. Thus,
this year the President's budget classifies the $1 billion for CMS
implementation of the MMA as discretionary.
In addition, the budget identifies approximately $500 million in
mandatory program savings for this Subcommittee's consideration. These
are four legislative proposals that I believe will lead to increased
cost effectiveness and reduced waste in the Medicare and Medicaid
programs. First, allowing beneficiaries to purchase durable medical
equipment after 13 months instead of 15 months is a lower burden for
our beneficiaries and a savings for Medicare, and it will improve
access to these products while reducing rental payments. Second,
requiring the Centers for Medicare and Medicaid Services (CMS) to use
the Administration for Children and Family's (ACF) wage database will
allow CMS to identify more quickly whether a beneficiary has employer-
sponsored insurance and to determine whether Medicare should be the
secondary payer, as opposed to the primary payer, to that other health
coverage.
Third, we are proposing to eliminate a windfall to the States by
reducing Federal reimbursement for Medicaid administrative costs by
about $300 million. Most states' TANF Block Grants were based on
expenditures that included the costs of determining Medicaid
eligibility, but they have also received Federal match for these
expenditures through Medicaid since TANF's implementation. Our proposal
seeks to eliminate this double payment for fiscal year 2005. Finally,
we are proposing to change the enhanced matching rates for
administrative activities toward systems' improvements, consistent with
other enhanced rates.
EXPANDING ACCESS TO HEALTH CARE FOR AMERICANS
One of the most important issues on which we can continue to work
together, is expanding access to quality health care for all Americans.
In 2002, the President launched an initiative to expand access to
health care by creating 1,200 new or expanded health care sites and
serving an additional 6 million people by 2006. Since the initiatives
inception, with the strong bi-partisan support of this Subcommittee,
the Health Centers program has significantly impacted more than 600
communities, serving over 13 million patients, 3 million more than in
2001, 40 percent of who have no health insurance coverage, and many
others for whom coverage is inadequate. In addition, States use Health
Insurance Flexibility and Accountability (HIFA) demonstrations to
expand health care coverage. As of January 2004, HIFA demonstrations
expanded coverage to 175,000 people and another 646,000 were made
eligible.
While we have made significant strides in this endeavor, there is
still much work to be done. In fiscal year 2005, the President's budget
request will continue to expand resources for Health Centers to a level
of $1.8 billion, an increase of $219 million over fiscal year 2004.
This increase will result in increased services for an additional 1.6
million people in approximately 330 new and expanded sites. This level
will provide access to comprehensive preventative and primary care
services, at over 3,800 health sites nationwide, for a total of almost
15 million uninsured and underserved individuals, nearly 7 million from
rural areas.
ACCESS TO RECOVERY
Mr. Chairman, the fiscal year 2005 budget represents the fourth
year of the President's strong commitment in leading our nation's
battle against addiction. With your support, we have made significant
progress. Current use of illicit drugs among students has declined by
11 percent between 2001 and 2003. However, there continues to be an
unmet need for drug treatment services. The fiscal year 2005 budget
will provide 100,000 individuals with drug and alcohol treatment
benefits by doubling funding to $200 million for the Access to Recovery
State Voucher Program. This program will allow individuals seeking
clinical treatment and recovery support services choices among
qualified community provider organizations, including those that are
faith-based. The program's emphasis is on objective results and is
measured by outcomes, including decreased or no substance use, no
involvement with the criminal justice system, attainment of employment
or enrollment in school, family and living conditions, and social
support.
DISEASE DETECTION AND BIOTERRORISM PREPAREDNESS
In the past three years, your support for our bioterrorism efforts
has been unwavering, and together we have made tremendous strides in
protecting our nation from various threats. While we have made great
strides, it is imperative that we remain steadfast in our commitment to
protect our nation and the well-being of all its citizens. The fiscal
year 2005 request for HHS bioterrorism activities is $4.1 billion, an
increase of $155 million above fiscal year 2004, and $3.8 billion above
the fiscal year 2001 level.
This work will be coordinated with the Global Disease Detection
Initiative at CDC. The Global Disease Detection Initiative (+$27.5
million) will help the United States learn more rapidly about new
disease threats that emerge in other Nations. CDC will recognize
infectious disease outbreaks abroad faster, and help those nations
identify and stop those diseases before they arrive in the United
States. In order to accomplish this task, CDC will expand its presence
internationally and collaborate with multinational organizations, such
as the World Health Organization (WHO) to improve overall global
disease detection, control, and surveillance. CDC will also invest an
additional $10 million to expand quarantine efforts at ports-of-entry
for international travelers.
Funds will be directed to carry out a new interagency bio-
surveillance initiative to prepare against a potential bio-terrorist
attack. The Centers for Disease Control and Prevention (CDC), in
coordination with the Food and Drug Administration (FDA), the
Department of Homeland Security, and the Department of Agriculture,
will be working to improve the response to bioterrorism through early
detection with the BioSense Surveillance Initiative. Through this
program, we will improve human health surveillance, strengthen the
laboratory response network, and increase the numbers of boarder health
and quarantine stations, which will allow us to identify and isolate
potential disease outbreaks more rapidly.
We also continue our work in building the Strategic National
Stockpile of drugs, vaccines and medical supplies that can be shipped
anywhere in the country on short notice, with a request for $400
million in fiscal year 2005. The fiscal year 2005 budget returns the
financing of the stockpile to HHS. DHS will continue to have the
authority to order deployment of the stockpile in an emergency, along
with HHS. The fiscal year 2005 budget includes a three-year financing
plan to expand our antibiotic stockpile to be able to provide post-
exposure anthrax treatment from 13 million to 60 million people. In
fiscal year 2005, we have included a contingency provision that will
allow us to transfer up to $70 million to the Stockpile from funds
available for State and local preparedness, should the added funds be
needed.
Our nation's ability to detect and counter bioterrorism ultimately
depends on the state of biomedical science, and the National Institutes
of Health (NIH) will continue to ensure full coordination of research
activities with other Federal agencies in this battle. The fiscal year
2005 budget includes $1.74 billion for NIH biodefense research efforts,
an increase of $120 million, or +7.4 percent. Included within this
biodefense total is $150 million to support the construction of
Biosafety laboratories for NIH to help develop medical protection from
bioterrorism, and to back up State and Federal public health
laboratories. Prior to fiscal year 2002, only a few laboratories in the
United States were capable of conducting research on potential bio-
terrorism agents. The $150 million investment in fiscal year 2005 will
fund an additional 20 Biosafety Level 3 laboratories across the
country.
The ability to mitigate the health effects of radiation exposure in
the potential event of the use of a limited nuclear or radiological
device in a terrorist attack presents a critical challenge for which
little progress has been made in the last forty years. For fiscal year
2005, $47 million is requested in the budget for the Public Health and
Social Services Emergency Fund, to be coordinated and managed by NIH.
This new initiative will support targeted research activities needed to
develop medical countermeasures to more rapidly and effectively treat
nuclear or radiological injuries.
Throughout my time as Secretary, many steps have been taken to
allow for improved access to vaccines for those in need and better
methods to combat the spread of influenza viruses. The average Medicare
reimbursement rate to physicians for the administration of the flu
vaccine increased from $3.98 per dose in CY 2002, to $7.72 in CY 2003,
an increase of +94 percent. The payment increased again in 2004 to
$8.25 per dose. In fiscal year 2004 and 2005, $40 million per year will
be used for creating a stockpile of children's influenza vaccine to
ensure this past year's shortages do not reoccur. While these previous
measures have improved access to vaccines, we must also look toward
future improvements. It is imperative that the United States develops
the domestic capacity to produce rapidly the vaccine our nation would
need in a pandemic. For that reason, the fiscal year 2005 budget seeks
to double to $100 million our investment to ensure a year round
production capacity for influenza vaccines to improve our preparedness
for an influenza pandemic, as well as develop production technologies
that could be scaled-up rapidly to provide surge capacity during a
pandemic.
CHILDHOOD VACCINES
The Budget includes two legislative proposals in Vaccines for
Children that I believe should be strongly supported by the members of
this Subcommittee. This legislation would enable any child who is
entitled to receive VFC vaccines to receive them at State and local
public health clinics. There are hundreds of thousands of children who
are entitled to VFC vaccines, but can receive them only at Community
Health Centers and other Federally Qualified Health Centers. The
proposal ensures VFC coverage of childhood vaccines for VFC eligible
children when they show up for services at a public health clinic.
Given the rising cost of childhood vaccines, ensuring access to VFC
vaccines for eligible children is especially important. Legislation is
also needed to restore tetanus and diphtheria vaccines to the VFC
program. The VFC authorization caps prices at such a low level that no
manufacturer will bid on a VFC contract. As a result, the vaccines that
are provided to VFC children through the public health system have to
be financed with scarce discretionary resources. Enactment of the
legislation the budget proposes would, at the same time, expand by $55
million the vaccines that are available to children while reducing by
$110 million the demand for vaccines financed with discretionary
appropriations.
CDC will continue to build a six-month, vendor-managed stockpile of
all routinely recommended childhood vaccines. Between fiscal year 2004
and fiscal year 2006, CDC will invest an additional $583 million to
meet target quantities needed for a six-month stockpile. Vaccines from
the stockpile can be distributed in the event of a disease outbreak and
will mitigate the effect of any potential manufacturing supply
disruption.
COMPLETION OF THE DOUBLING OF NIH
I commend you, Mr. Chairman, and this Subcommittee, for your
commitment in doubling the budget for the National Institutes of
Health, consistent with the President's request. Building on the
momentum generated by the fulfillment of the President's commitment to
complete the five-year doubling of the NIH budget, the fiscal year 2005
request provides $28.8 billion for NIH. This is an increase of $764
million, or +2.7 percent, over the fiscal year 2004 level. In fiscal
year 2005, over $24 billion of the funds requested for NIH will flow
out to the extramural community, which supports work by more than
217,000 research personnel affiliated with 2,000 university, hospital,
and other research facilities across our great nation. These funds will
support a record total of nearly 40,000 research project grants in
fiscal year 2005, including an estimated 10,393 new and competing
awards.
NIH remains the world's largest and most distinguished organization
dedicated to maintaining and improving health through the use of
medical science. Major advances in scientific knowledge, including the
sequencing of the human genome, are opening dramatic new opportunities
for biomedical research and providing the foundation for un-imagined
results in preventing, treating, and curing disease and disability.
Investment in biomedical research by NIH has driven these advances in
health care and the quality of life for all Americans, and the fiscal
year 2005 budget request seeks to capitalize on the resulting
opportunities to improve the health of the nation.
In an effort to target gaps and opportunities that no single NIH
institute could solve alone, the fiscal year 2005 budget allocates $237
million for the Roadmap for Medical Research initiative, an increase of
$109 million (or +85 percent) over fiscal year 2004. This initiative
consists of three core themes of establishing new pathways to
discovery, inventing the research teams of the future, and re-
engineering the clinical research enterprise.
COMMUNITY AND FAITH-BASED INITIATIVES
In support of the President's Community and Faith-Based Initiative,
the fiscal year 2005 budget maintains a commitment toward programs that
link community and faith-based organizations with State, local
governments, and Federal partners programs. The initiative creates
results by empowering those at the community level, who can best
identify the social and health related problems. Those at the community
level can then act to produce positive results and be agents of change
in the lives of the most needy.
The President's budget requests a total of $100 million for the
Compassion Capital Fund, doubling the fiscal year 2004 level. Initiated
in fiscal year 2002, the Compassion Capital Fund awards grants to
organizations which provide technical assistance to help faith-based
and community organizations access funding sources, operate and manage
their programs, develop and train staff, expand the reach of programs
into the community, and replicate promising programs.
As our nation's prison population continues to rise, another
important program that reaches our most vulnerable children is the
Mentoring Children of Prisoners program. Studies indicate that children
with incarcerated parents have a seven times greater chance of becoming
incarcerated themselves and are more likely to succumb to substance
abuse, gangs, early childbearing, and delinquency. This budget request
includes $50 million, maintaining the fiscal year 2004 level, to
provide grants to enable public and private organizations to establish
or expand projects that provide mentoring for children of incarcerated
parents and those recently released from prison. This activity will
give 30,000 adolescent children of prisoners a beacon of hope in their
world of despair.
The President's budget includes $10 million for Maternity Groups
Homes as part of the Transitional Living program. This will provide
pregnant and parenting youth who cannot live safely with their own
families access to adult-supervised community-based group homes, and a
range of coordinated services including childcare, job training, and
counseling.
HEAD START PROGRAM
One of the most fundamental truths in our society today is the
necessity for a solid educational background to allow all children the
opportunity to succeed. The initial educational experience is the
bedrock of our children's healthy growth and development. Mr. Chairman,
with the generous support of this Subcommittee, we have made a
significant difference in this beginning stage of our children's growth
and development. This commitment towards meeting the needs of our most
vulnerable citizens is unwavering and remains stronger than ever with
the 2005 President's budget request of $6.9 billion for Head Start.
This is an increase of $169 million over the fiscal year 2004 level. In
fiscal year 2005, 919,000 children will receive Head Start services
including 62,000 children in the Early Head Start program.
In fiscal year 2005, we will continue to emphasize the goals of the
President's Good Start, Grow Smart Initiative to strengthen Head Start
by partnering with States, by providing information on child
development and early learning to teachers, caregivers, parents, and
grandparents, and close the gap between research and practice in early
education. The fiscal year 2005 request includes $45 million to support
the President's initiative to improve Head Start by funding nine State
pilot projects coordinating State preschool programs, Federal child
care grants, and Head Start into a comprehensive system of early
childhood programs for low income children. The budget also includes
$124 million to maintain competitive salaries for Head Start teachers
and to support program enhancements in early literacy and cognitive
development.
PREVENTION INITIATIVES
More than 1.7 million Americans die of chronic diseases--such as
heart disease, cancer, and diabetes--each year, accounting for 79
percent of all U.S. deaths. Although chronic diseases are among the
most common and costly health problems, they are also among the most
preventable. The budget includes $915 million for CDC's Chronic Disease
Prevention and Health Promotion program, an increase of $62 million
over fiscal year 2004.
Within this request is $125 million, an increase of $81 million,
for the Steps To A Healthier U.S. Initiative. This increase will fund
the State and community grant program initiated this past September to
reduce the prevalence of diabetes, obesity, and asthma-related
complications, targeting those at high risk. Last year these funds
reached 23 communities, including seven large cities, one Tribal
consortium, and 15 smaller cities and rural areas, and more areas will
benefit during the upcoming year. Also a total of $10 million will be
used to expand the Diabetes Detection Initiative, which targets at-risk
populations. The aim of this initiative is to reach these populations
where they live, work, and play through a customized, tailored approach
with the aim of identifying undiagnosed diabetes.
The fiscal year 2005 budget request for the CDC National Breast and
Cervical Cancer Early Detection Program (NBCCEDP) is $220 million, an
increase of $10 million over fiscal year 2004. This program has helped
to increase mammography use by women aged 50 and older by 18 percent
since the program's inception in 1991. Efforts are targeted toward low-
income women with little or no health insurance and have helped to
reduce disparities in screening for women from racial and ethnic
minorities. With the requested increase, an additional 32,000
diagnostic and screening services will be provided to women who are
hard-to-reach and have never been screened for these cancers.
MENTAL HEALTH TREATMENT
In meeting the President's goal of transforming the mental health
system and increasing access to mental health services for some of our
most vulnerable citizens, the fiscal year 2005 budget includes $913
million in discretionary funding for mental health services, an
increase of $51 million over fiscal year 2004, or +6 percent. As an
important step in reshaping this delivery system, the budget proposes
$44 million for State Incentive Grants for Transformation. These new
grants will support the development of comprehensive State mental
health plans to reduce system fragmentation and increase services
available to people living with mental illness.
Recent studies have found that 20 percent of individuals
experiencing chronic homelessness also have a serious mental illness.
This request proposes $10 million for the Samaritan Initiative, an
Administration-wide initiative to reduce chronic homelessness, jointly
administered with the Departments of Housing and Urban Development and
Veterans Affairs. Through this initiative, States and localities will
develop processes to better enable access to the full range of services
that chronically homeless people need, including housing, outreach, and
support services such as mental health services, substance abuse
treatment, and primary health care.
FIGHTING HIV /AIDS
HIV is one of the most serious and destructive challenges facing
humanity in our world today. No country, whether large or small, rich
or poor, can escape the devastation it brings. All have citizens whose
lives have been destroyed by this horrible disease, and our commitment
to ending this pandemic is both strong and unwavering. No nation in
history has ever committed the time, energy, and fiscal resources that
the United States has invested in this effort. The fiscal year 2005
total HHS budget will continue this emphasis with the request for HIV/
AIDS funding of $15 billion, or +31 percent over fiscal year 2001 for
both domestic and global HIV/AIDS prevention, care, treatment, and
research activities.
Specifically, the fiscal year 2005 budget includes $784 million for
States to purchase medications for persons living with HIV/AIDS. At
this level, monthly AIDS Drug Assistance Programs will increase from
93,800 clients in fiscal year 2004 to 100,000 clients in fiscal year
2005. Also included is $53 million for the HIV/AIDS in Minority
Communities activities to support innovative approaches to HIV/AIDS
prevention and treatment in minority communities.
MARRIAGE AND HEALTHY FAMILY DEVELOPMENT
The President announced an expanded initiative to build on research
that there are life-long benefits of growing up in married-parent
families. This initiative, comprised of new and existing programs, has
four elements: (1) supporting marriage and families; (2) providing
tools to parents; (3) teaching values to children; and (4) encouraging
community and faith-based organizations to support families.
Within this initiative is $273 million to help parents and
communities provide teens with the tools to make responsible choices
and abstain from early sexual activity. The budget includes $50 million
to support a new program that will assist non-custodial fathers in
becoming more involved in their children's lives, and $107 million to
nearly double funding for State child abuse programs to reduce the
incidence of child abuse and neglect and increase services to those who
are victims.
HEALTH CARE INFORMATION TECHNOLOGY
Improvements in the safety, effectiveness, and efficiency of health
care, as well as in public health preparedness, can best be achieved by
the accelerated use of health information technology (IT). Therefore,
the fiscal year 2005 budget requests $50 million in new funding for a
Health Care IT initiative. This amount, by funding demonstrations and
investing in private sector and public program partnerships, will
accelerate the development and utilization of modern IT in both health
care and public health. These investments will assist development by
the private sector of needed standards, examine ways the use of IT can
be encouraged, coordinate actions across all agencies, and ensure that
this investment will further the national health information
infrastructure.
These resources will be made available to local, regional, tribal
and State data exchange networks and organizations, to provide the
infrastructure necessary for exchange of a patient's health information
within that area, and with other such organizations nationally. In
addition, technical assistance and resources to these networks and
information infrastructures will be available. These investments will
complement and build upon the Agency for Healthcare Research and
Quality's (AHRQ) demonstration grants and other activities to evaluate
the effects of IT on the safety and quality of health care--a critical
component of assuring that IT's positive benefits are adopted broadly.
MODERNIZATION AND REFORM INITIATIVES
With the enactment of Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, the Department faces many challenges in the
coming fiscal year. A top priority for CMS, and all Operating Divisions
within HHS, will be the timely implementation of the sweeping changes
in the law. As the most significant reform of Medicare since its
inception in 1965, the law expands health choices for beneficiaries and
adds a prescription drug benefit. MMA will strengthen and improve
Medicare, while providing beneficiaries with new benefits and the
option of retaining their traditional coverage.
Along with Medicare reform, the President remains fully committed
to strengthening and empowering America's families through legislation
supporting welfare reform, modernization of Medicaid and SCHIP,
increased child support enforcement, and reform of the child welfare
system.
MANAGEMENT IMPROVEMENTS
Finally, I would like to update the subcommittee on the
Department's efforts to use our resources and the taxpayer's dollars in
the most efficient manner. To this end, HHS remains committed to
setting measurable performance goals for all HHS programs and holding
managers accountable for achieving results. I am pleased to report that
HHS is making steady progress. We have made significant strides in
streamlining and making performance reporting more relevant to both
decision makers and customers. As a result, the Department is better
able to use performance results to manage and to improve programs. By
raising our standards of success, we will continue to improve
efficiency and increase our ability to improve the health of every
American citizen.
IMPROVING THE HEALTH, SAFETY, AND WELL-BEING OF OUR NATION
Chairman Specter and members of the Subcommittee, I would like to
thank you once again for your passion and support in working with us in
this fight to improve the health, safety, and well-being of all
Americans. The budget I bring before you contains proposals from many
different areas. These programs, from enhancing the building blocks for
our youngest and most vulnerable with Head Start, to expanding Health
Centers to increase the access to quality health care for minorities,
to protecting our nation from the threat of bio-terrorism, all meet
vital needs within our communities. All of these proposals, which vary
greatly in substance, are put forth with one simple overarching goal of
ensuring the health, safety, and well-being of all Americans. I know
that this goal is one that we share together, and I look forward to
your continued support as we move toward turning our passionate
commitment into positive results for the American people.
Senator Specter. Thank you very much, Mr. Secretary.
We will now proceed with our customary 5-minute rounds.
PRESCRIPTION DRUG BENEFIT ESTIMATES
Mr. Secretary, the morning news reports are filled with the
testimony of Mr. Richard Foster before a House committee
yesterday, where he, in his capacity as the Medicare programs
chief actuary, told House Members that he gave an analysis last
June to the White House and the President's Budget Office which
was not shared with the Congress, predicting that prescription
drug benefits being drafted on Capitol Hill would cost about
$150 billion more than President Bush said he wanted to spend.
And he further reported that unnamed administration officials,
or perhaps they are named, threatened to fire him.
I have two questions for you on that. Do you have any
personal knowledge that the cost estimate of $150 billion was
concealed? And, second, do you have any personal knowledge
about the alleged threats?
Secretary Thompson. Senator, let me quickly respond, as
accurately as I possibly can. Number one, I read in the paper,
after the alleged threat by the Administrator of CMS--I had my
chief of staff immediately----
Senator Specter. The first you knew about it was reading
about it in the newspaper?
Secretary Thompson. No, no. This was way back in June when
this took place. I read about it in the newspaper, I heard
about it, and I had my chief of staff call----
Senator Specter. And my question is: The first time it came
to your attention was when you heard news reports?
Secretary Thompson. That is correct. Last June.
Senator Specter. Okay.
Secretary Thompson. And then I had my chief of staff
contact Mr. Foster and tell him, directly from me, that his job
was not in jeopardy.
Now, the actuary's assumptions, based upon that, was only
for the first section of Senate bill 1, and that was $550
billion. I did not know of that figure. I did know of the
assumptions that Rick Foster had projected that we would be
having more people participate in Medicare, by 94 percent
versus CBO's number of 87 percent that was publicized. The
Congress knew about that. The administration knew about that.
And that was the big difference.
The second difference on the cost estimates was based upon
how much is going to be used by low-income seniors. We assumed
that it's going to be a lot more than CBO. CBO scores it at 87
percent. We score it at 94 percent. That is a difference of
about a $100 billion of the $134 billion difference between CBO
and our actuary. That's based upon assumptions. Those figures
were known--not the exact figures. The fact is, is that we knew
that they were going to be more, and we made that to be known
to the Congress.
Senator Specter. Well, focus specifically on what Mr.
Foster----
Secretary Thompson. Okay.
Senator Specter [continuing]. Has said. And that is that he
had a figure of $154 billion more than the President's figure,
and he did not tell Congress about that $150 billion more.
Secretary Thompson. Senator, that was based upon an earlier
bill. That was Senate bill 1 that was introduced--that was the
chairman's score from the Finance Committee. That was not the
bill that was debated on the floor of the Senate or the House
of Representatives. Those figures didn't come out until
December of this past year, after the bill passed.
Senator Specter. So are you saying that his allegation is
factually incorrect, that he did not have information about
$150 billion excess beyond what the President wanted to spend,
and that he did not conceal that from the Congress?
Secretary Thompson. I'm saying that the $150 billion
difference is based upon an earlier version of the bill, and
the final version is $134 billion, and that didn't come out
until December 13. And the $150 billion was based upon only the
first section of the bill. And there was no--to the best of our
knowledge, and we have looked through all the records--there
has not been any written record where any Member of Congress
has asked for the earlier assumptions or the earlier figures.
And that's why I've asked the inspector general of my
Department to get all the facts so that we can report it to
Congress. I have asked the inspector--have asked the Inspector
General to make a detailed report to me and to Congress.
Senator Specter. My red light just went on, and I want to
observe the time limits, so I'll turn now to Senator Harkin.
Senator Harkin. Mr. Secretary, I think the record will show
here that you might have made a little bit of a misstatement,
because I made a note on this. You said you read about this
last June in the news reports. You did not read about it last
June.
Secretary Thompson. Yes, I did.
Senator Harkin. There was a news report last June----
Secretary Thompson. Yes, there was.
Senator Harkin [continuing]. In the newspapers----
Secretary Thompson. Absolutely.
Senator Harkin [continuing]. Saying that there was this
higher estimate?
Secretary Thompson. No. No, there was a--the newspaper
article that was last June was--is that--it came out, it was
reported by AP, that Mr. Foster had been threatened that he was
going to lose his job if he didn't send up--and what was
requested was the score on the benefits of the particular bill,
on premium support.
Senator Harkin. Premium support, that's----
Secretary Thompson. Premium support. And that was what was
requested. That was what Tom Scully had told Rick Foster not to
send up. That's what was said.
Senator Harkin. Okay.
Secretary Thompson. Then Tom Scully says, ``Somebody made
the allegation that you're going to get fired if you send it
up.'' When I heard that, I asked my chief of staff to call--
which he did--call Mr. Foster and say, ``Your job is not in
jeopardy at all.'' Mr. Foster has testified to that.
Senator Harkin. Okay, then, I still wonder why we were not
given those numbers.
Secretary Thompson. We've looked at it, Senator Harkin, and
we do not believe there has ever been a written request from
any Member of Congress--neither the Senate or the House had
ever requested for those figures. Those figures were
preliminary figures on Senator Grassley's bill, and it was only
on the benefit portion, on the drug portion, not the total
bill. And that figure was $551 billion. And the last figure
that deals with the bill that was passed was $534 billion.
Senator Harkin. Uh-huh.
Secretary Thompson. That's $17 billion difference, and
that's--and Rick Foster testified yesterday that the final
figures did not come out until the latter part of December,
after the bill passed.
Senator Harkin. That's right. But on June 3, Foster made
his higher estimate. That's one. That was $150 billion.
Secretary Thompson. That is--but that was on a different
bill. That was on----
Senator Harkin. That was on S. 1.
Secretary Thompson [continuing]. S. 1. But that was--that
was the chairman's mark, and that was only on the drug benefit.
It wasn't on the other seven provisions of the bill, the other
seven chapters.
Senator Harkin. Okay. So then the bill passed in November,
but the bill that passed--it was somewhat different than S. 1,
obviously.
Secretary Thompson. Completely different.
Senator Harkin. Well, I don't know that it was completely
different; it was somewhat different. But are you saying that
it made no difference whether or not we knew there was $150
billion more, or what the estimates were by the time the bill
passed?
I guess it just seems to me that, you know, who knew what,
when, and how they knew it, and all that kind of stuff. It just
seems to me that we have a fundamental question here. Do you
think it should be the policy of the administration, any
administration, that the actuaries officers at CMS provide
technical assistance to Members of Congress, as I understand
the practice was before this year? Now, I could be mistaken on
that. But I understand the practice was that the actuaries
office at CMS provided information to the relevant committees.
Secretary Thompson. We have looked at that, and that was
not the practice, and that's why there was some report language
put in, in the Balanced Budget Act, because members of the
Republicans were not able to get it from the actuary under the
previous administration.
But to answer your question, Senator Harkin, I think that
that information should be made available, and I have testified
to that previously.
Senator Harkin. I agree with you, because obviously it was
collected at taxpayers' expense. I mean----
Secretary Thompson. Yes, sir.
Senator Harkin [continuing]. This is not some private
entity doing this, and that--those figures ought to be
available for policymakers. I don't know what the end result is
going to be, but I hope it is that we have access to these kind
of figures in the future, I hope.
Secretary Thompson. I think you should. I think you will.
The CBO numbers are the ones that are--and those are the ones--
the CBO still says it's $395 billion, not the $534 billion. And
there's a logical explanation that I could go into if you would
want me to, Senator Harkin.
Senator Harkin. My time is up. I hope we get a second
round, because I did want to ask you about the Wellness
Program.
Senator Specter. There will be a second round, Senator.
Senator Harkin. Thank you, Mr. Chairman.
Senator Specter. Senator Cochran.
DRUG REIMPORTATION
Senator Cochran. Mr. Secretary, we've had some debates and
votes on amendments here in the Senate relating to importation
of pharmaceutical products from other countries. Are there
sufficient funds in this budget request to deal with the
problem of counterfeit or unsafe pharmaceutical products that
may enter the United States from other countries?
Secretary Thompson. I don't think so, Senator. I think it's
a growing problem, and I think that we are doing the best job
possible. As you know, I requested this Congress, early on when
I came on, to get enough inspectors to deal with some things
with food. We have increased it. But, overall, I still think
that there is a good chance of having counterfeit drugs. And we
see that every time we stop. We had, as you know, some
inspections at the border not too long ago, one in July and one
in September and October of this year, and about 87 percent of
the drugs that came in were either mislabeled, mis-packaged--
some were counterfeit, some were not certified by FDA, or
approved by FDA. So a lot of drugs that come into America are
not regulated by the FDA.
Senator Cochran. Are you making an effort to bring this to
the attention of our friends around the world, and try to get
help there in those countries?
Secretary Thompson. We are. We have a very strong,
aggressive outreach program to other countries, especially to
Canada. But Canada has pretty much indicated that it's not
their problem, and it's our problem, and that we should address
it ourselves. We have started hearings. Last Friday was the
first hearing. I set up a commission, headed up by Surgeon
General Carmona, to take a look at reimportation, importation,
as well as ways in which we can develop it.
We've also set up a task force on counterfeit drugs, and we
announced that a couple of weeks ago. We're working with the
Federal Trade Commission and the Department of Justice in
regards to that.
We're quite aggressive, but your question was, are there
enough resources? I don't think there are, because FDA is very
strapped with all of its demands. And this is a huge problem,
and if, in fact, we are going to have reimportation, we're
going to have more resources in order to make sure that this
reimportation of drugs are safe.
VACCINES
Senator Cochran. In connection with the availability of
vaccines to deal with threats to the public health----
Secretary Thompson. Yes.
Senator Cochran [continuing]. There seems to be a gap
between what we should have and what we do have in the way of
an inventory of vaccines, being able to locate them, and then
mobilize our resources to deliver them where they may be needed
in case of an outbreak of a disease or illness. Is there any
effort in the budget to deal with that problem by providing
funding to the Centers for Disease Control or other agencies
that could help move us in the direction to deal with that more
effectively?
Secretary Thompson. Absolutely, there is, and you've
already done a great deal, and I wish you could just come down
and see how we track this. We have got the country split up
into 12--in 10 regions, but we have 12 strategic locations
where we have 600 tons of medical supplies, antibiotics,
vaccines that we can strategically deploy to any city in
America within 7 hours. It takes nine semi-truck loads or a KC-
135 in order to do so. And we track that.
We also have got, at the present time, enough smallpox
vaccine, 400 million doses, to vaccinate every man, woman, and
child in America. We have enough doxycycline and Cipro, as far
as anthrax is concerned, to treat 14 million people in America
for 60 days. We have money in here to go to 20 million, which
is a huge increase of supplies that we're going to have to put
in the supplies depots, but we're going to do that.
We are asking for a BioShield, which is still tied up in
Congress, and this is going to allow us to reach out to the
pharmaceutical and biological companies to develop new vaccines
for tularemia, for the plague, and for hemorrhagic
superviruses, and so on.
We're doing a lot, but we can always do more. I'm very
satisfied with where we are, but I know that we can improve,
and that's what we intend to do.
Senator Cochran. Thank you very much for your efforts in
this area. It's so important to homeland security and the
health and safety of our American citizens.
Secretary Thompson. I would hope you'd come down and see
us, Senator.
Senator Cochran. I'll do that. I need to go to the Center
for Disease Control, too. I've never gone down there to take a
tour around. I've seen photographs of some of the buildings
that need upgrading----
Secretary Thompson. Senator Specter's been down there. I'd
like you to come down there. It's worth your time to do it.
We're only a block away. If you come down, I can get you
through in a half an hour, 45 minutes, and I can show you
exactly how we track diseases and storms and whatever we've got
to face. It's really an educational type of thing, and it's
really--I invite you. I'd love to have you come down and host
you and get a chance to see it.
Senator Cochran. I accept your invitation, with pleasure.
Secretary Thompson. Thank you.
ORASURE
Senator Specter. Mr. Secretary, a Pennsylvania company,
Orasure Technologies, Incorporated, in Bethlehem, has developed
a 20-minute HIV test, and I know you're familiar with it.
Secretary Thompson. I'm very excited about it, Senator.
Senator Specter. On March 10, Orasure met with HHS
officials regarding additional purchases through the Substance
Abuse and Mental Health Administration, and was led to believe
that SAMHSA had committed to a $13 million purchase order;
however, SAMHSA has now told staff that no such commitment has
been made, and any potential purchase will be less than $5
million. You and I have exchanged correspondence on it. I would
be interested to know whether there was any commitment for a
$13 million purchase, and what you anticipate by way of a
purchase in light of the remarkable technology at hand and the
tremendous need for determining, in Africa and other places,
whether the people have HIV/AIDS?
Secretary Thompson. I can't answer you specifically as to
what was committed by SAMHSA, or if there was a
misunderstanding, but I will get an answer to you very quickly.
I'm sorry about that, that I don't have it at the top of my
head, Senator Specter.
[The information follows:]
Orasure
We are committed to using new technology to identify undiagnosed
HIV-positive individuals, help them reduce risk of transmission, and
refer them to care. In fiscal year 2003 CDC bulk-purchased $2 million
of rapid tests (250,000 kits), and has placed an additional $2 million
order for fiscal year 2004. We have also encouraged our international
partners to consider the OraQuick tests in their efforts to identify
individuals with HIV/AIDS. The Global Assistance Program countries
frequently use OraQuick as a tie breaker when two less expensive tests
give different results.
SAMHSA submitted a request to the HIV/AIDS in Minority Communities
Fund to purchase HIV rapid test kits for its HIV/AIDS grantees. At this
time, no final decision has been made about the level of funding
available for this request. The HIV/AIDS in Minority Communities Fund
supports innovative approaches to HIV/AIDS prevention and treatment in
communities of color. Each year HHS agencies/offices submit proposals
for activities to reduce the disproportionate impact of HIV/AIDS on
racial and ethnic minorities. In fiscal year 2003, a total of eight
agencies/offices received dollars from this fund. It is our hope to
reach final decisions on these dollars very shortly.
GLOBAL FUNDS FOR AIDS, MALARIA, AND TUBERCULOSIS
Secretary Thompson. In regards to Africa, as you know, I'm
chairman of the Global Fund for fighting AIDS, malaria, and
tuberculosis. I advised--we just came back from Geneva this
past--we had our seventh board meeting, and I advised the board
of this new, innovative idea that Orasure has come up with. The
problem we have in the Global Fund is that it will use Orasure
to be the arbitrator. They don't use it for the basics. I mean,
they have a cheaper product. And if there's some question as to
the accuracy, then they bring in Orasure to determine for sure.
When they came out with this new quick test, I'm hoping to be
able to push through the Global Fund to be able to be a bigger
user of Orasure's product, because I'm very sold on it, and I'm
very--I think the company is doing a tremendous job, and I
think it could help save us money in the future.
Senator Specter. Well, thank you for that answer and for
your assurances that you will take a look to see what
commitments----
Secretary Thompson. I will.
Senator Specter [continuing]. Have been made by SAMHSA or
others in your Department.
CDC AND NIH BUDGETS
A two-part question, Mr. Secretary. Your budget document
states there is a growing concern that the next public-health
emergency could overwhelm current capacities to respond, and
would likely overwhelm CDC's current capabilities. How can we
realistically cut the CDC budget by $116 million on their
overall budget, and almost 180 million on their buildings and
facilities, in the light of their mission and the tremendous
threats?
The second question I have for you relates to the budget of
the National Institutes of Health, where we are facing a
situation with the administration request to lead to a drastic
curtailment of NIH awards.
If you would respond to those two questions, I would
appreciate it.
Secretary Thompson. Thank you. And let me quickly respond
so I can get to both of them.
In regards to CDC, let me say that I let you down, Senator.
I did not sell as effective as I thought I should have been
able to, to get a little more money into buildings. That is the
big difference in the reduction at CDC. As you all know, and
you've been the leader in this, we're trying to get $250
million a year down there, and we came in with a budget of $82
million, of which $40-some million is going to Fort Collins.
That is the big difference. A reduction in the VERB program was
the other. I gave Director Gerberding, Assistant Secretary
Julie Gerberding, an allotment of what she could do. She came
in with the best budget she could. I think it's quite good.
In regards to overwhelming the resources, the biggest thing
I'm concerned about right now is a pandemic flu, and we have
put some additional money in there, $50 million in the CDC,
I've got $50 million into my accounts, in order to try and make
sure that we are prepared to try and move companies from the
egg culture to the cell culture, especially with avian flu that
may come or may not come. I am very concerned about that. And
avian flu could have the potential for destroying some of the
egg stock because it affects chickens, and so we're trying to
do something.
In regards to NIH, we still, under our budget, are going to
be able to give out more grants. Where we saved the dollars was
reducing what was called the cost of increase to the cost of
inflation over the 4-year grants, and we reduced that
approximately from about 3.3 percent down to about 1.3 percent.
But next year, even if our budget--if Congress doesn't put more
money into it, there will be more grants out there than there
has been before. And since I've been Secretary, thanks to you,
the Congress leadership in giving us the dollars, we have gone
up by 30 percent in grant applications, in grant requests, in
grant approvals, and 42 percent increase in the amount of
dollars that those grants have been able to receive.
Senator Specter. My red light went on in the middle of your
answer, Mr. Secretary. And we will be submitting more detailed
questions on NIH----
Secretary Thompson. Thank you.
Senator Specter [continuing]. For the record.
Secretary Thompson. I would be more than happy to answer
them, sir.
Senator Specter. We've been joined by the distinguished
chairman of the full committee.
Senator Stevens.
HEALTHCARE DELIVERY
Senator Stevens. Thank you, Mr. Chairman. I do have three
other areas to stop by--I stopped by here, Mr. Chairman,
because I don't think any person in history has brought more
hope to the Alaska native people in the area of healthcare
delivery than Secretary Thompson, and I'm----
Secretary Thompson. Thank you.
Senator Stevens [continuing]. Here to thank you very much
and, what's more, to invite you back again. Your annual visits
really bring great hope to our people.
ALASKA DENTAL ASSOCIATION
You may be interested to know that yesterday, for the first
time, the American Dental Association, the Alaska Dental
Association, approached me with the idea of trying to interface
some dental care into the village health clinics. That has been
a total gap, in terms of the care----
Secretary Thompson. Huge gap.
Senator Stevens [continuing]. Of Alaska natives. It's
really great news. They came forward on their own, and I look
forward to working with you and with your people on trying to
partnership with them. They're willing to take on part of the
cost. It's a very interesting thing.
POSITRON EMISSION TOMOGRAPHY
I also am grateful to you for what you've done to help us
try to move CMS forward to bring about the favorable coverage
decision for PET, positron emission tomography. I do believe,
Mr. Chairman, that there's no system that holds more hope for
dealing with the baby-boom generation than PET, in terms of
trying to get a handle on Alzheimer's and those diseases
related to dementia. And, clearly, if we follow through in that
generation with the amount of Alzheimer's we've had in my
generation, the cost is going to be overwhelming. We must find
some way to deal with it, and at least PET will give us a
chance for our medical researchers going ahead to try and find
a cure to slow it down and to provide the opportunity, through
the prescription drugs already on the scene, to deal with
severe symptoms and to give those seniors with Alzheimer's a
chance to have a fairly decent life as they can--into that
terminal period. I can't thank you enough for that.
I do have a couple of questions that I would like to submit
for the record, if I may, Mr. Chairman. And I thank you for
your courtesy.
OBESITY
My last comment would be, keep up the battle against
obesity.
Secretary Thompson. Thank you.
Senator Stevens. You know, we're just back on a journey
through the Middle East, Mr. Secretary--Jordan, Iraq, Kuwait,
Pakistan, Afghanistan, and even into France. We're the only
nation that really has this terrible, terrible addiction to
obesity, that I saw on that whole trip. Not our military men
and women, thank God. They get the discipline when they're
fairly young, and I hope it carries through for them. But for
our community at large, I think obesity is becoming a number-
one challenge to our survival. So I would hope we would all
join with him and help him as much as possible.
Thank you for your courtesy.
Secretary Thompson. Thank you very much, Senator Stevens,
and let me just thank you for your leadership. And, yes, I will
be back in Alaska. I told you I'd go back to Alaska every year
as long as I'm Secretary, and we've made some progress; not as
much as you or I would like, but we're making some, and we'll
be back there, and we've still got to work on the water and
sewer for Alaska natives, because that is still--it's a huge
problem, and I know you're the leader in that that, and I
applaud you.
prepared statement
Senator Stevens. Well, when your nearest neighbor is 500
miles away in every direction, and you have a hundred people,
hope is a great thing.
Secretary Thompson. Yes, sir.
Senator Stevens. And you've brought hope to those people,
and I want to help you continue that.
Secretary Thompson. Thank you very much.
Senator Stevens. Mr. Chairman.
[The statement follows:]
Prepared Statement of Senator Ted Stevens
Thank you Mr. Chairman. Secretary Thompson, it's a pleasure to see
you here today. Once again I want to express my appreciation for your
leadership on a host of issues that are of vital importance to all
Americans. I especially want to thank you for all that you have done
for Alaska. We are looking forward to having you visit us again this
summer.
I am also very grateful to you for helping get C.M.S. moving
forward to a favorable coverage decision for PET scans to help diagnose
Alzheimer's disease in Medicare patients at an earlier time than any
other diagnostic test. That coverage will give many seniors who
discover they have Alzheimer's a chance to slow the progress of the
disease with medication before its incapacitating symptoms appear.
Mr. Secretary, I believe we will be facing a crisis of huge
proportions when Alzheimer's begins to strike the baby boom generation.
I hope our investment in medical research at NIH will produce a cure
before that time. But, in the meantime, early diagnosis of Alzheimer's
disease, through pet, coupled with currently available prescription
drugs begun at a stage before the most severe symptoms appear, will
help many seniors continue to lead productive and reasonably healthy
lives.
I'm also pleased that you were finally successful in including
funding in your fiscal year 2005 budget for the Denali Commission.
While it is less than our fiscal year 2004 number, I know that you have
worked hard to have those funds included in your budget because you
have seen first hand many of the infrastructure projects the commission
has funded in remote parts of Alaska.
I am concerned that several programs that fund rural health
activities, like the Rural Outreach grants and Rural Hospital
Flexibility grants have been eliminated. Both of these programs, while
relatively small ones, have benefited remote communities in Alaska and
other rural States that need special help to provide needed health
services. I know this is a very tight budget, but I urge you to work
with the subcommittee to restore funding for these programs.
Another matter of concern to me is our Nation's growing epidemic of
obesity. Mr. Secretary, you are to be applauded for your personal
leadership in this area, beginning with your putting the Department on
a diet and encouraging physical activity. I hope you will continue to
push forward, because yours is a message we must heed. A recent report
from the CDC tells us that obesity will soon overtake smoking as the
Nation's leading cause of preventable death. I will be pleased to work
together with you in your efforts to make us a healthier Nation.
Mr. Secretary, again I thank you for your tireless efforts to
improve the health and well being of Alaskans and other Americans.
Senator Specter. Thank you, Senator Stevens.
Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
MONEY FOLLOWS THE PERSON INITIATIVE
Mr. Secretary, as I said in my opening statement, I know
you've long supported the right of people with disabilities to
choose to live in their neighborhoods and communities, rather
than nursing homes and institutions. Along with Senators
Specter and Smith, we introduced a bill last summer to get the
Money Follows the Person Initiative, as it's called, enacted
last summer. As I said earlier, you included funds for this
initiative in your fiscal year 2005 budget, for which we're
very appreciative. I understand the Finance Committee is going
to hold hearings on this issue on April 7. Again, these are all
good first steps, but we really need your support to get this
bill moving through Congress and signed into law.
I haven't really heard of any real opposition to it. It's
just, sort of, we've got to get it moving. You know, we hear a
lot of talk about the New Freedom Initiative and everything,
and we're all very supportive, but nothing seems to happen. I
guess I'm just asking if you could really help with the
administration and getting this thing moving through Congress
this year. That's all I'm asking.
Secretary Thompson. Absolutely. I am as passionate about
it, hopefully, as you are, Senator. And I want to see it done,
because I'm not going to be here next year, and I want to make
sure that we get it through before I leave, and then I'm--I
have talked to Senator Grassley on it, and he's going to hold a
hearing on it. I'm hoping he'll get the bill introduced quickly
so we can start getting co-authors on it and start getting
bipartisan support. I don't think there's that much--any
opposition to it. I think we've just got to get the time to get
it through the committee and on the floor and through both
houses. And I know the President's going to sign it. So let's
work together on a bipartisan basis and make sure it gets
completed this year.
Senator Harkin. Well, I appreciate that, and I just--
whatever we can do to help, but you can also be very
influential in----
Secretary Thompson. Thank you.
Senator Harkin [continuing]. Move it through. And I know
you're passionate about it. And I agree with you, we've got to
get it through this year.
FOOD LABELING
The second part of my question is, I had--I said I'm--
again, I'm really appreciative of all that you're doing
personally, and, through you, your Department, on this issue of
obesity and wellness, and personal wellness as, sort of, a
thing that we've got to be focusing on. I am somewhat puzzled,
however, by the fact that many of the recommendations
pertaining to the food industry and the labeling of foods,
especially restaurant foods, are voluntary rather than
mandatory.
As the FDA report notes, food consumed away from the home
has increased from 33 percent of consumers' food budgets in
1970 to 47 percent in 2002. Over the same period, total
calories consumed from food purchased outside the home
increased from 18 percent to 32 percent. I guess my question is
this: Why, then, despite FDA's own assertion that the food
labeling required under the original National Labeling
Education Act has been helpful to the consumers, and despite
the fact that your focus groups show that consumers would like
more labeling in restaurants, why do does the report recommend,
quote, ``urge'' the restaurant industry to launch a nationwide,
quote, ``voluntary'' and point-of-sale information campaign for
customers, rather than some sort of mandatory labeling
requirement? I guess that's the essence of my question. Why
voluntary? Why not have some mandatory labeling requirement for
that information?
Secretary Thompson. It's a different way to approach the
problem. I'm not saying one approach is that much better over
the other one. Every month I sit down with a different group of
people. I've met with the Restaurant Association now three
times. I have asked them to put more information on their
menus. Most of them are complying. It was a tough sell in the
first meeting. Every meeting since then has been getting
better, Senator. And the last one was a very friendly meeting
in which they were volunteering many more menu items that are
going to be heart-healthy and low carbs and better, and they're
going to be more informative.
Number two, I have met with the health insurance companies
many times. I met the health insurance, health companies,
medical companies, and so on. I do this on a monthly basis. I
bring in a different group to talk about prevention. And we
continue to do that. We're holding a summit, I believe, next
week, in Baltimore, on prevention, and we're having, I believe,
1,200 people that have signed up already to do it. So I'm using
the bully pulpit because I believe, like you do, of $1.5
trillion, 75 percent is for chronic illnesses--$155 billion for
tobacco-related diseases, 442,000 people die; $135 billion for
diabetes, 200 million Americans die; $117 billion on obesity.
And I think we can do a lot better job. And I just think right
now we can do it by pushing rather than hammering them.
Senator Harkin. Well, Mr. Secretary, I was here when we
pushed through the labeling for packaged goods in grocery
stores. We had the same arguments then from the grocery people.
The grocery manufacturers--oh, my gosh--``We changed the
contents of boxes. We can't be doing this. And it's just going
to be awful. It's just going to cost so much money.'' We went
ahead and did it, and, you know, not even a blip. And yet
people rely on that today. They go to grocery stores--it's
taken some years, but now you look, I think the figures are
over 60-some percent in surveys--people go to grocery stores,
look at those labels to find out what they're buying.
Now, Ruby Tuesday, I don't know anybody--I don't know Ruby
Tuesday--who owns it or who runs it, but I have a feeling they
had a lot to do with these people now being more willing to put
things on their menus, because Ruby Tuesday voluntarily said
they're going to put it all in.
Let me just show--where's my chart? They were saying how
onerous it was going to be. Here's a typical menu. And all they
did is, they put the calories, the saturated fat, and sodium
for each item. It's not a big deal.
Secretary Thompson. It is not.
Senator Harkin. It's not a big deal.
Secretary Thompson. And it's very enlightening. And that's
what we've got. We're changing the labeling out at FDA. We set
up a committee. We're going to have some new labels with more
information as to calories, portion size. And that's coming to
FDA.
Senator Harkin. But, again--and I know my time is up--I'm
all for volunteerism, but FDA is also in the business of
regulation and mandating, and we've been through this before,
because it is such a health crisis. I, again, urge you to get
the FDA involved in setting down a mandatory--there's
legislation here, as you know, to do that, pending in the
Senate and the House, to get the FDA to set down regulations on
information of fat, calories, sodium on menus in restaurants.
Rather than urging them--and you can urge and urge and urge.
Some will do it, but not all of them will.
Secretary Thompson. I think you're going to see a lot of
that kind of information on the labels when we come out later
on this summer, Senator.
Senator Harkin. Well, I hope so.
Secretary Thompson. I think you'll be very happy with it.
Senator Harkin. But, again, I guess my rhetorical response
might be, well, should we undo the regulations on the labeling
regarding packaged good, and just make that voluntary?
Secretary Thompson. No.
Senator Harkin. Of course not. Of course not. So I think
this is, sort of, the next step in that, and I still believe
that--I hope voluntarily everybody does it, but then you're
going to have--maybe one will voluntarily put this information,
someone will put this information.
Secretary Thompson. No, we're going to have uniform
standards, and I'm going to be rolling those out this summer.
Senator Harkin. But they'll be voluntary.
Secretary Thompson. Most of them will be at this point.
Senator Harkin. So I won't have to abide by it. I'll put
whatever I want to on it. Rather than putting the total
calories and what that double-cheese, double-whatever-it-is,
and these fries, I might put it on for a 6-ounce portion.
Secretary Thompson. I think we're going to be much more
successful than you think, Senator.
Senator Harkin. Well----
Secretary Thompson. I hope, anyway.
Senator Harkin. Well, we can hope. We can hope. But it
seems to me they've got to be pretty stringent and
straightforward. But if it's voluntarily, you'll get a mismatch
of all kinds of different information on stuff, and they will
try to confuse people, because we've seen that happen in the
past without the kind of things we have on the packaged goods.
And we have a problem there, too, a little bit, as you know,
because they use different sizes. And the FDA is getting ready
to address that, and I applaud that.
Secretary Thompson. Yes, we are.
Senator Harkin. Thank you, Mr. Chairman, for letting me go
over my time.
Senator Specter. Thank you, Senator Harkin.
HEALTH PROFESSIONS
Mr. Secretary, there are three questions that I would like
to state now, and ask you to respond to for the record.
With respect to health professionals, Mr. Secretary, I
would like you to answer, for the record, how we can
realistically cut the $300 million reduction on those programs
in light of the urgent shortage of health professionals,
especially in rural areas. Your budget justifies that by an
additional $25 million to the National Health Service Corps,
which, frankly, I don't see the relationship. But if you would
respond for the record, we would appreciate it.
ABSTINENCE EDUCATION
Number two, on the abstinence initiative, this is a program
that I think is very meritorious, abstinence education, and we
would like a response on the evaluation that your Department is
having as to how well these programs are working.
STEM CELL RESEARCH
And, third, as to stem cells, this continues to be a highly
controversial subject. Those who oppose embryonic stem-cell
research seek to tar those who favor it with the accusation
that human cloning is supported, which, of course, is factually
untrue. It's totally different, nuclear transplantation. But we
would like you to respond as to your evaluation as to the
availability of the 63 lines the President referred to on his
famous declaration, back on August 9, 2001 in his 9 o'clock
speech--the line was expanded to 70--and what has happened
there, and how many of those are really usable, untainted with
mouse feeder, and what is happening elsewhere. We hear periodic
reports, but you are the central figure in the Federal
Government. Give us the specifics on what's going on in South
Korea or other places, or what Harvard is doing with reported
$100 million program, another report about things going on in
Minnesota. And I see these periodically in the press, but we
really ought to collate all of this in one central repository
so we know what is happening on this very important subject,
which is the cutting edge of real opportunity to make inroads
against the most dreaded maladies of the era. I know your
personal thinking on the subject, and I know that--the
complexities of the issue, but, at the minimum, as of this
time, we ought to have the facts before us as to what is
happening there to make a judgement.
Well, thank you very much for coming in, Mr. Secretary.
Secretary Thompson. Thank you, Senator.
Senator Specter. I'd like to meet with you privately for a
moment or two after the hearing.
ADDITIONAL COMMITTEE QUESTIONS
There will be some additional questions which will be
submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Arlen Specter
HEALTH PROFESSIONS
Question. With respect to health professionals, Mr. Secretary, I
would like you to answer, for the record, how we can realistically cut
the $300 million reduction on those programs in light of the urgent
shortage of health professionals, especially in rural areas?
Answer. Over the past two decades, we have invested over $6 billion
on general health professions training grants. However, as we shape
future spending, we will concentrate on directly supporting efforts
that improve health professions shortages, focus on emerging workforce
demands, and meet the needs of the underserved.
The President's budget makes a substantial investment in expanding
access to health care to underserved communities through the Health
Centers program and the National Health Services Corps. In fiscal year
2005, the Health Centers program is on-track to meet the President's
five-year goal to increase access to health care in 1,200 communities
with new and significantly expanded health center sites and increase
the number of people served by over 6 million. Further, the President's
budget supports approximately 2,750 loan repayments and scholarships
for health care professionals in the neediest communities through the
National Health Services Corps program.
The new rural health care investments created by the Medicare
Prescription Drug, Improvement and Modernization Act (MMA) will mean
greater access to hospitals, health professionals and other medical
services for rural seniors. It is estimated that the major rural
provisions of the MMA will increase Medicare spending in rural America
by $20 billion over 10 years. In addition to substantially increasing
Medicare reimbursement for rural hospitals, a focal point for health
care in rural communities, the MMA will also increase reimbursement for
physicians, and other health care providers, in rural areas. For
example, the Act establishes a new 5 percent incentive payment for
physicians practicing in physician scarcity areas which include many
rural communities.
ABSTINENCE
Question. On the abstinence initiative, this is a program that I
think is very meritorious, abstinence education, and we would like a
response on the evaluation that your Department is having as to how
well these programs are working.
Answer. The Department is currently funding two independent,
rigorous, longitudinal evaluations of abstinence education programs.
The first is an on-going evaluation of a select number of State Section
510 abstinence education programs. It is being conducted by Mathematica
Policy Research (MPR). The second evaluation effort is currently in
design phase. It will examine the effectiveness of community-based
abstinence education programs and other approaches to teen pregnancy
and STD prevention. Both of these evaluation efforts are overseen by
the Office of the Assistant Secretary for Planning and Evaluation
(ASPE).
An implementation report from the ongoing MPR evaluation was issued
in April 2002. It documented a wide range of abstinence education
programs that have been well received. They are innovative in their
approach to promoting abstinence as the healthiest choice for youth.
These programs incorporate activities that have been shown to be
effective: an emphasis on goal setting; developing decision-making
skills; getting parents, schools, and communities involved in
supporting the healthy development of youth.
The programs are diverse, creative, and offer youth much more than
a single message of abstinence. Youth responded positively to program
staff who showed a strong and unambiguous commitment to the program
message, and programs that used an intensive set of youth development
services to enhance and support the abstinence message were very well
received. The report showed that addressing peer pressure is difficult,
and many programs have struggled to address these issues and engage
parents in this process. This report also offered a description of the
ways in which programs have partnered with local schools to provide
abstinence education, highlighting some of the challenges to creating
and sustaining these partnerships.
The MPR evaluation has an end date of September 30, 2006. The
original time frame in the statute under which the evaluation project
is operating was through September 2001. However, the contractor and
others have recognized the need for a longer-term follow-up period in
which to examine the program effects on youth. As a result, the
contract period has been extended through September 2006.
ASPE is also in the process of designing an evaluation of
community-based abstinence education activities and other approaches to
teen pregnancy and STD prevention. ASPE contracted Abt Associates to
develop evaluation designs for a longitudinal, rigorous impact study,
which will help best answer some of the original policy questions that
were the impetus for this study. The study will follow adolescents
through high school, and will measure the impact of these programs on
behavioral outcomes, including the reduction and prevention of out-of-
wedlock pregnancies and sexually transmitted diseases (both viral and
bacterial). Other key outcome variables of interest include age at
first sexual activity and intercourse, frequency of sexual activity and
intercourse, and number of individuals who postpone sexual activity or
intercourse through adolescence.
STEM CELL RESEARCH
Question.What is the status of the human embryonic stem cell (hESC)
derivations listed on the NIH Stem Cell Registry? How many are in
private hands? How many have been grown on mouse feeder layers? How
many are viable?
Answer. All of the derivations listed on the NIH Human Embryonic
Stem Cell Registry are privately owned by 15 different companies or
academic institutions. The providers indicated by an asterisk (*) below
are recipients of the NIH Infrastructure award to develop, characterize
and distribute cell lines.
BresaGen, Inc., Athens, Georgia*
--4 derivations
--3 lines available
--The cells in derivation BG04/hESBGN-04 failed to expand into
undifferentiated cell cultures.
Cell & Gene Therapy Research Institute (Pochon CHA University),
Seoul Korea
--2 derivations
--0 lines available
Cellartis (formerly Cell Therapeutics Scandinavia), Goteborg,
Sweden*
--3 derivations
--2 lines available
--Cell line SA03/Salgrenska 3 was withdrawn by donor.
CyThera, Inc., San Diego, California*
--9 derivations
--0 lines available
--The cells failed to expand into undifferentiated cell cultures.
ES Cell International, Melbourne, Australia*
--6 derivations
--6 lines available
Geron Corporation, Menlo Park, California
--7 derivations, all duplicates of Wisconsin Alumni Research Fdn.
derivations
Goteborg University, Goteborg, Sweden
--16 derivations, reported to have not been exposed to mouse feeder
layers
--0 lines available
Karolinska Institute, Stockholm, Sweden*
--6 derivations
--0 lines available
--The cells failed to expand into undifferentiated cell cultures.
Maria Biotech Co. Ltd.--Maria Infertility Hospital Medical
Institute, Seoul, Korea
--3 derivations
--0 lines available
MizMedi Hospital--Seoul National University, Seoul, Korea*
--1 derivation
--1 line available
National Centre for Biological Science/Tata Institute of
Fundamental Research, Bangalore, India
--3 derivations
--0 lines available
Reliance Life Sciences, Mumbai, India
--7 derivations
--0 lines available
Technion-Israel Institute of Technology, Haifa, Israel*
--4 derivations
--2 lines available
University of California, San Francisco, California*
--2 derivations
--2 lines available
Wisconsin Alumni Research Foundation, Madison, Wisconsin*
--5 derivations
--5 lines available
Of the 78 entries on the Registry, 71 are from independent embryos
and 7 are duplicates located at both WiCell (Wisconsin Alumni Research
Fdn.) and Geron. The Geron cell lines are not being widely distributed
to the research community.
Of the 71 independent derivations:
--16 have failed to expand into self renewing, pluripotent cell lines
(9 at CyThera, 1 at BresaGen, 6 at Karolinska), and 1 line was
withdrawn by the donor at Cellartis (formerly Cell Therapeutics
Scandinavia, CTS). NIH provided Infrastructure support in
failed attempts to expand these 16 derivations into
distribution-quality cell lines.
--Of the remaining 54 independent derivations, 21 are available for
shipment, after expansion and characterization using NIH
Infrastructure grant awards. The 21 that are currently
available are:
BresaGen, Inc.--BG01, BG02, BG03
Cellartis--SA01, SA02
ES Cell International--ES01, ES02, ES03, ES04, ES05,
ES06 4
MizMedi Hospital--MI01
4Technion-Israel--TE03, TE06
UCSF--UC01, UC06
WiCell--WA01, WA07, WA09, WA13, WA14
--Of the remaining 33 independent derivations, 2 more are at
institutions with NIH Infrastructure awards. If these 2 were
developed into distribution quality cell lines ready for
shipment, there would be 23 independent cell lines available to
the research community. The 2 cell lines under development are:
Technion-Israel--TE04, TE07
--The remaining 31 independent derivations are all at institutions
located outside of the United States that have not applied for
NIH Infrastructure awards to develop their cell lines. Any
plans to develop these derivations into cell lines that are
available to the research community are unclear at this time.
The 31 derivations at institutions that do not have
Infrastructure awards are:
Pochon CHA (Korea)--2 derivations
Goteborg Univ. (Sweden)--16 derivations
Maria Biotech (Korea)--3 derivations
National Centre for Biological Sciences (India)--3
derivations
Reliance Life Sciences (India)--7 derivations
As far as we know, all derivations have been exposed to mouse
feeder cells, with the exception of the 16 derivations at Goteborg
University (Sweden).
Information on the detailed characteristics of each of the
derivations is available on the NIH Human Embryonic Stem Cell Registry,
http://escr.nih.gov.
Question. What is Happening at Harvard University?
Answer. On March 25, 2004, Harvard University announced the
derivation of 17 hESC lines in an article published in the New England
Journal of Medicine. Funding for the derivations and distribution of
these lines is being provided by the Howard Hughes Medical Institute,
Juvenile Diabetes Research Foundation and Harvard University.
On April 23, Harvard University announced the establishment of the
Harvard Stem Cell Institute. According to Harvard, the Institute will
encourage adult and embryonic stem cell research using both animal and
human stem cells. The Institute has two co-directors: Harvard Medical
School Professor David Scadden, who also directs Massachusetts General
Hospital's Center for Regenerative Medicine and Technology, and Douglas
Melton, the Thomas Dudley Cabot Professor of the Natural Sciences and a
Howard Hughes Medical Institute investigator.
Research at the Institute will be focused on five areas of disease
for which stem cell therapy seems most promising. The diseases all
result from some sort of organ or tissue failure and include: diabetes,
neurodegenerative diseases, blood diseases, immune diseases,
cardiovascular disease, and musculoskeletal diseases.
Although research on the 17 new human embryonic stem cell (hESC)
derivations are not eligible for Federal funding, NIH is currently
supporting several scientists at Harvard University whose hESC research
use lines eligible for Federal funding. Dr. Doug Melton is working to
identify the genes involved in hESC self-renewal and differentiation.
Dr. George Daley is studying hematopoietic development from hESCs. Dr.
Howard Green is working to develop the culture conditions to coax hESCs
to become the keratinocytes that make up human skin's epidermis. Dr.
Jeffrey Harper is analyzing the signals that control hESC division.
Question. What is Happening in South Korea? What is Happening in
Other Countries?
Answer. On February 12, 2004, South Korean researchers published
the first scientifically credible report of the creation of a cloned
human embryo in the laboratory by means of somatic cell nuclear
transfer (SCNT) (Science 303: 1669-1674.) These scientists, supported
by the South Korean government, then used these cloned embryos to
establish a human embryonic stem cell line. They combined the DNA of a
woman's ovary cell with her donated egg, from which the nucleus had
been removed, and then stimulated the newly combined cell to divide.
The resulting very early embryo was then allowed to develop to the
blastocyst stage (five to nine days), at which point it was
disaggregated and the highly potent stem cells of the inner cell mass
were removed. These stem cells were then treated to produce a stem cell
line to be used for various kinds of biomedical research. Subsequent to
the publication of the SCNT study, the South Korean government voted to
ban the creation of cloned human embryos, but might allow cloning for
biomedical research on a case-by-case for medical treatment subject to
approval by a National Bioethics Advisory Commission. Scientists will
be permitted to use spare frozen embryos, left over from infertility
treatments and kept in laboratories for at least five years, for
limited stem cell research into treatments for hard-to-cure diseases.
The regulations banning human cloning are expected to come into effect
after President Roh Moo-hyun signs the bill. The regulations on stem
cell research will go into effect in 2005.
Other International Stem Cell Efforts
International Society for Stem Cell Research (ISSCR)
The International Society for Stem Cell Research is an independent,
nonprofit organization established to promote and foster the exchange
and dissemination of information and ideas relating to stem cells, to
encourage the general field of research involving stem cells and to
promote professional and public education in all areas of stem cell
research and application. Opinions on the legitimacy of experiments
using human embryos vary among members of the European Union (EU)
according to the different ethical, philosophical and religious
principles in which they are grounded. EU member states have taken very
different positions on the regulation of human embryonic stem cell
research and cloning for biomedical research. More information about
the regulations and policies of EU members can be found on the website
of the ISSCR at the following link: http://www.isscr.org/scientists/
legislative.htm.
The International Stem Cell Forum (ISCF)
The ISCF was founded in January 2003 to encourage international
collaboration and funding support for stem cell research, with the
overall aim of promoting global good practice and accelerating progress
in this vitally important area of biomedical science. The Forum's long-
term aim is to help stem cell scientists achieve a range of
revolutionary medical advances that will benefit people throughout the
world. The ISCF is led by the United Kingdom's Medical Research Council
and consists of 14 leading supporters of stem cell research from around
the world. Member organizations are based in the United States,
Finland, Australia, Canada, Germany, France, Israel, Netherlands,
Japan, Singapore, Sweden, Switzerland, and the United Kingdom. Within
ISCF, the United States is represented by the NIH. The Juvenile
Diabetes Research Foundation International (JDRF) is also a member of
the ISCF. One short term goal of the ISCF is to compare different stem
cell lines from the member organizations. As part of this goal, NIH's
federally approved stem cell lines will be compared to those of other
member organizations. Information about the stem cell research efforts
of the member organizations can be found on the website: http://
mrc.live.tmg.co.uk/.
PREPARED STATEMENT RECEIVED
Senator Specter. We have received the prepared statement of
Senator Mary L. Landrieu. The statement will be placed in the
hearing record.
[The statement follows:]
Prepared Statement of Senator Mary L. Landrieu
With the release of the 2005 budget, President Bush emphasized his
commitment to reducing the deficit, most of which has been created by
his fiscally irresponsible policies, within five years. The overall
budget proposed by the President cuts domestic discretionary spending
outside of homeland security by $49 billion by 2009, a 12 percent cut
in spending. A large portion of the domestic discretionary spending
that the Administration proposes to cut from 2005-2009 is administered
by the Department of Health and Human Services and provides services
such as child care, child welfare, and health care to our poorest
children, families, and seniors.
Because it is an election year, the Administration has attempted to
hide their lack of support for domestic spending by playing a shell
game. When questioned about their commitment to important social
issues, the Administration touts its minor increases in some programs
in the 2005 budget as evidence of their ``compassionate conservatism.''
Yet, if you look closely enough you will see that after this year,
these ``increases'' continue to shrink until they sink below current
funding levels by 2009.
Although I am supportive of almost any policy aimed at bringing the
economy back into an era of surpluses, as we enjoyed during the Clinton
years, I believe the President's method for trying to achieve a
reduction in deficits through cuts in spending on our most vulnerable
populations is at best, flawed. Because domestic discretionary spending
outside of homeland security only accounts for one-sixth of the overall
budget, the President's proposed cuts would not significantly reduce
the deficit. What they will do, however, is increase financial burdens
on states at a time when they are experiencing the worst fiscal crises
since WW II. estimates show that states will face deficits of $40
billion or more in 2005. It is predicated that my own state of
Louisiana will face a deficit of $500 million this year. Under the
decreased federal funding in the President's new budget, Louisiana and
other states will be forced to impose deeper cuts on programs such as
government subsidized health insurance and child care subsidies for the
poor.
In his budget, President Bush does not limit his cuts to
discretionary spending but also proposes cuts in entitlement spending
for many of these programs. It is unbelievable to me that in a time of
a recession, this President proposes to cut support for TANF, child
care, child welfare, and other social services by over $2.8 billion.
While his TANF re-authorization calls for increases in the number
of hours that fathers and mothers must work, the budget flat funds
child care assistance to these families. Over the last year 100,000
children have lost assistance and predictions indicate that at least an
additional 200,000 children will lose assistance by 2009 under the
current budget proposal. The TANF entitlements funds are also flat-
funded, though 8.2 million people are unemployed and more families are
at risk of reliance on the welfare system. And although President
Bush's policies have contributed greatly to the dire situation many of
these families face, he continues to turn his back on them by refusing
to provide adequate funding to the government programs that will allow
them to survive these difficult times.
The Administration's proposal for health care reflects an equal
lack of compassion towards these low-income families. Our country's
problem of the uninsured has reached a crisis level, with almost 44
million individuals who are not insured. Predictions show this problem
is getting even worse. Yet, the Administration is proposing further
cuts in aid to low-income individuals through Medicaid, calling for a
reduction in funding for Medicaid by nearly $1 billion in 2005 and by
nearly $16 billion over the next ten years. And the President is
attempting to unload this crisis onto states by pushing for turning
Medicaid into a block grant. The result would be a cap on the amount of
money the federal government would spend on this program and a shift of
costs to the states, preventing them from being able to respond to the
dynamic health care needs of their residents.
President Bush is proposing a similar funding structure for foster
care payments to states. Under this proposal, states would be given the
option to receive block grants in place of entitlement funding that is
typically provided for services to foster children. These block grants
would freeze funding to states at a specific level for five years,
meaning that the funds would no longer be based on need or the number
of eligible children. This cost neutral proposal does not increase
funding to a foster care system that is already under-funded. In fact,
many programs that have been block-granted in the past have ended up
with less funding over time. Although I do support a federal funding
structure for child welfare services that allows states the flexibility
to be innovative in meeting the challenges of families involved in this
system, the President's proposal of block granting will ultimately
result in states having less resources to provide necessary services.
Understanding that these families face complex and varying
challenges, I support the President's budget proposal that would
increase funding for Promoting Safe and Stable Families to $505
million. This program offers flexible funding to states for a range of
community-based family support and adoption services. This money can be
used for prevention and family preservation services that help to keep
children with their biological families and out of the child welfare
system. Although I am happy to see that the Administration has
recognized the importance of this program by proposing increased
funding, I hope that it will modify proposals for other child welfare
programs to provide adequate funding to assist families.
Investments in programs that focus on prevention, such as those
provided through the Promoting Safe and Stable Families funding, are
cost-saving. By investing in these primary services, our government
avoids investment in solving problems that could have been prevented.
Unfortunately, the President's budget proposal for substance abuse
services under the Substance Abuse and Mental Health Administration
does not reflect this idea, with over 2\1/2\ times the amount of
funding proposed for prevention services dedicated to treatment
services. I support the increases that President Bush is proposing for
these treatment services, for this funding will aid in the healing of
individuals and families who suffer from substance abuse issues.
However, I further support increases in funding for prevention
services, so that we can help families avoid the problems associated
with substance abuse.
As lawmakers and appropriators, we have the responsibility to act
on the idea that we can always do more to help the people we represent.
We cannot be complacent with this budget. Much more can be done for
some of our most vulnerable populations that are served through the
Department of Health and Human Services than what is outlined in the
President's budget. Using my seat on the Appropriations committee, I am
committed to seeing valuable programs proposed to receive cuts by the
Administration receive the funding that is necessary to meet the needs
of those they are intended to serve.
SUBCOMMITTEE RECESS
Senator Specter. Thank you all very much. The subcommittee
will stand in recess to reconvene at 9:30 a.m., Thursday, April
1, in room SH-216. At that time we will hear testimony from the
Honorable Elias Zerhouni, Director, National Institutes of
Health.
[Whereupon, at 10:35 a.m., Thursday, March 25, the
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
April 1.]