[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
A REVIEW OF THIS YEAR'S FLU SEASON: DOES OUR PUBLIC HEALTH SYSTEM NEED
A SHOT IN THE ARM?
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
FEBRUARY 12, 2004
__________
Serial No. 108-143
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
93-723 U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2003
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�090001
COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri
CHRIS CANNON, Utah DIANE E. WATSON, California
ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia C.A. ``DUTCH'' RUPPERSBERGER,
CANDICE S. MILLER, Michigan Maryland
TIM MURPHY, Pennsylvania ELEANOR HOLMES NORTON, District of
MICHAEL R. TURNER, Ohio Columbia
JOHN R. CARTER, Texas JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee ------ ------
------ ------ ------
------ ------ BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
C O N T E N T S
----------
Page
Hearing held on February 12, 2004................................ 1
Statement of:
Gerberding, Dr. Julie, Director, Centers for Disease Control
and Prevention; Dr. Anthony S. Fauci, Director, National
Institute of Allergy and Infectious Diseases; and Dr. Janet
Heinrich, Director, Public Health Issues, General
Accounting Office.......................................... 12
Stroube, Dr. Robert, Virginia State health commissioner,
Association of State and Territorial Health Officials;
Karen N. Miller, president, National Association of
Counties, commissioner, Boone County, MO, accompanied by
Dr. Susan Allan, health director, Arlington County Public
Health Division, Department of Human Services; Howard Pien,
president and chief executive officer, Chiron Corp.; Dr.
James Young, president, research and development,
MedImmune, Inc.; and Dr. Shelley A. Hearne, executive
director, Trust for America's Health....................... 87
Letters, statements, etc., submitted for the record by:
Cummings, Hon. Elijah E., a Representative in Congress from
the State of Maryland, prepared statement of............... 157
Davis, Chairman Tom, a Representative in Congress from the
State of Virginia, prepared statement of................... 3
Deal, Hon. Nathan, a Representative in Congress from the
State of Georgia, prepared statement of.................... 160
Fauci, Dr. Anthony S., Director, National Institute of
Allergy and Infectious Diseases, prepared statement of..... 42
Gerberding, Dr. Julie, Director, Centers for Disease Control
and Prevention, prepared statement of...................... 15
Hearne, Dr. Shelley A., executive director, Trust for
America's Health, prepared statement of.................... 141
Heinrich, Dr. Janet, Director, Public Health Issues, General
Accounting Office, prepared statement of................... 62
Miller, Karen N., president, National Association of
Counties, commissioner, Boone County, MO, prepared
statement of............................................... 109
Pien, Howard, president and chief executive officer, Chiron
Corp., prepared statement of............................... 115
Stroube, Dr. Robert, Virginia State health commissioner,
Association of State and Territorial Health Officials,
prepared statement of...................................... 90
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 7
Young, Dr. James, president, research and development,
MedImmune, Inc., prepared statement of..................... 133
A REVIEW OF THIS YEAR'S FLU SEASON: DOES OUR PUBLIC HEALTH SYSTEM NEED
A SHOT IN THE ARM?
----------
THURSDAY, FEBRUARY 12, 2004
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:19 a.m., in
room 2154, Rayburn House Office Building, Hon. Tom Davis
(chairman of the committee) presiding.
Present: Representatives Tom Davis, Duncan, Miller, Waxman,
Tierney, Van Hollen, and Norton.
Staff present: Melissa Wojciak, staff director; David
Marin, deputy staff director/communications director; Ellen
Brown, legislative director and senior policy counsel; Drew
Crockett, deputy director of communications; Susie Schulte,
professional staff member; Teresa Austin, chief clerk; Brien
Beattie, deputy clerk; Phil Barnett, minority staff director;
Anna Laitin, minority communications & policy assistant; Sarah
Despres, minority counsel; Josh Sharfstein, minority
professional staff member; Earley Green, minority chief clerk;
Jean Gosa, minority assistant clerk; and Cecelia Morton,
minority office manager.
Chairman Tom Davis. Good morning. A quorum being present,
the committee will come to order. I want to welcome everybody
to today's oversight hearing on our public health system's
response capabilities to manage a pandemic of contagious
disease.
This year's flu season has raised the urgent question of
whether our country is prepared to deal with a pandemic, be it
a naturally occurring pandemic or one that results from a
bioterrorist attack. Today we will examine what actions and
planning procedures have been taken by Federal, State and local
health officials to handle this year's flu season and other
communicable disease outbreaks. Only then can we determine the
potential needs of government and health officials to respond
effectively to all types of contagious disease threats.
Although this year's flu season was not a large-scale
epidemic, several thousand people have died from complications
of the flu. Additionally, several thousand people were unable
to be vaccinated due to limitations of the vaccine supply.
While the flu virus is airborne and spreads easily, vaccination
significantly decreases the risk of illness and helps prevent
the spread of the flu virus.
Preparing for the annual flu season highlights the
importance of strong cooperation between different health
agencies and private sector companies at all levels. We need to
ensure that adequate production capacities for flu vaccine
manufacturers exist in order to avoid a vaccine shortage next
year. Once a flu pandemic is identified, it is important to
determine what the public and private sector capabilities are
to produce, distribute and administer diagnostics, vaccines,
and drugs for this problem. This year's vaccine shortage begs
the question: ``Are new mechanisms and incentives needed to
guarantee that effective and safe drugs, vaccines, and
diagnostics can be produced as quickly as possible?''
The current influenza season has challenged our public
health system's capabilities and provides us with a chance to
evaluate existing procedures and safeguards. The Public Health
Security and Bioterrorism Preparedness in Response Act of 2001
provided substantial new fundings for States, localities, and
hospitals to boost preparedness to respond to a highly
contagious disease, including influenza. The legislation
included new grant programs, educational efforts, State
planning requirements, expansion of Federal disaster teams,
pandemic preparedness resources, and new authority to deal with
public health emergencies. We will take a look at how these
programs are being implemented and if funds are being allocated
properly.
I understand some of our witnesses this morning will
express concerns about the actual preparedness levels and
Federal funding for States and localities. I look forward to a
constructive dialog on those concerns. I know we all share the
same goal at the end of the day: a public health system
prepared to deal with an outbreak of a deadly and contagious
disease.
The threat of a public health disaster emphasizes the need
for planning and practice. The quicker the health community
responds, the quicker a prevention and control strategy can be
developed, and appropriate treatments can be identified. This
hearing will recognize if any deficiencies in coordination,
communication, and capacities exist and will facilitate
discussions of how to work toward improvements necessary for
more effective preparedness. In order to be adequately
prepared, we should always be expecting the unexpected.
We have a great selection of witnesses today. I want to
thank all of them for appearing with us, and I look forward to
their testimony.
[The prepared statement of Chairman Tom Davis follows:]
[GRAPHIC] [TIFF OMITTED] T3723.001
[GRAPHIC] [TIFF OMITTED] T3723.002
Chairman Tom Davis. I will now yield to Mr. Waxman for an
opening statement.
But let me say before Mr. Waxman, we have the D.C. Young
Suffragists here to watch the hearing today, over here to our
side, and let me thank all of our young people here today.
Thank you for being with us.
Mr. Waxman. Thank you, Mr. Chairman. Let me start by
thanking you for calling this hearing today. I especially
appreciate your interest in public health at this relatively
quiet moment--before the next crisis comes.
Public health issues either dominate the news--think of
SARS and anthrax and monkeypox--or it is woefully ignored.
Hearings like this one provide an important opportunity to take
a step back and assess how far we have come in supporting our
public health system and what more needs to be done.
We know that there will be another public health crisis,
and many experts believe that this next crisis could be a
global flu pandemic. In a regular flu season, about 36,000
Americans die from the flu. A pandemic could be far worse. The
flu pandemic of 1918 cost millions of lives around the world,
including about 500,000 in the United States. The next flu
pandemic could be right around the corner. If the ``bird flu''
virus in Asia acquires the capacity to spread rapidly from
human to human, we could be facing a pandemic.
This year's flu season exposed some of the weaknesses in
our public health system. As reports of deaths among children
mounted, demand for flu shots spiked. Because the demand
exceeded supply, the country faced a potentially very dangerous
vaccine shortage. This frightening situation led many to ask
why the supply was inadequate to meet the demand.
The answer is revealing. Public health authorities
recommend that about 185 million Americans get the flu vaccine
every year. However, vaccine manufacturers make only about half
this amount because they estimate, correctly, that only a
fraction of those who should get the vaccine will actually do
so.
The implications of this situation are sobering. Without an
increase in demand, companies may not develop and sustain the
capacity to produce sufficient quantities of a life-saving
vaccine against a pandemic strain.
The solution is not to wait for a pandemic to hit. We need
to increase the use of the flu vaccine each year and to enhance
the role of the Federal Government in assuring manufacturers
that there will be a growing market for their vaccines.
I am concerned, however, that the President's fiscal year
2005 budget undercuts flu vaccination efforts. Today, the State
health commissioner in Virginia will testify that the
President's budget does not include adequate funding to cover
flu shots for children. His testimony is that, if adopted, this
budget ``will damage immunization efforts.''
Today is also an opportunity to take stock of our overall
public health readiness. In the wake of the attacks of
September 11, 2001, and the increased concern about the threat
of bioterrorism, Congress has appropriated several billion
dollars to State and local public health efforts. This funding
led to some improvements, such as in the area of emergency
communication. However, there continue to be major gaps.
For example, there are gaps in planning. The nonpartisan
Trust for America's Health reported in December 2003 that only
a quarter of the States have flu pandemic plans. The General
Accounting Office will testify today that not a single State
has a plan for hospital response to an epidemic involving at
least 500 patients--only 500 patients.
There are also gaps in lab preparedness. In June 2003, the
Trust for America's Health released a report finding that
public health laboratories are ``dangerously unprepared for an
attack using chemicals as weapons.'' We will hear additional
testimony today about gaps in training, education and emergency
response.
At this key moment, the Federal Government's commitment to
public health is essential. Investing in public health protects
not only against a flu pandemic, but also against a new
infectious disease and potential bioterrorist threats.
Unfortunately, the President's budget is again a major
disappointment. While it extends tax cuts for the richest
Americans, this budget cuts CDC funding 3 percent and reduces
the amount of money going to State and local governments for
public health readiness by over $100 million.
The President has assured the American people that he is
doing everything possible to protect them. His public health
budget indicates otherwise. This is a budget that does not take
advantage of this brief respite between public health crises to
prepare adequately for the next one.
Congress needs to be sure that the budget it passes does
not make the same mistakes.
I thank the witnesses for appearing today. I look forward
to their testimony.
I thank you again, Mr. Chairman, for convening this
important hearing.
[The prepared statement of Hon. Henry A. Waxman follows:]
[GRAPHIC] [TIFF OMITTED] T3723.003
[GRAPHIC] [TIFF OMITTED] T3723.004
[GRAPHIC] [TIFF OMITTED] T3723.005
[GRAPHIC] [TIFF OMITTED] T3723.006
[GRAPHIC] [TIFF OMITTED] T3723.007
Chairman Tom Davis. Thank you.
Are there any other Members that wish to make opening
statements? Hearing and seeing none, we now move to our first
panel of witnesses.
We have Dr. Julie Gerberding and Dr. Anthony Fauci, who
will discuss efforts being taken at the Federal level to
respond to the influenza virus. They will also describe
preparedness coordination efforts with State and local
authorities. Dr. Janet Heinrich, the Director of Public Health
Issues for GAO, will discuss the GAO report that was released
this week regarding State and local preparedness in the event
of a bioterrorism attack.
It is the policy of the committee that all witnesses be
sworn, so if you would rise with me and raise your right hands.
[Witnesses sworn.]
Chairman Tom Davis. Be seated. I think we have been through
the rules. We have a light in front of you. It turns orange
after 4 minutes, red after 5 minutes. Try to sum up in that
time. Your total statement is already in the record, and
questions will be based on the total statement.
Dr. Gerberding, we will start with you and move down the
way, and thank you very much for being with us.
STATEMENTS OF DR. JULIE GERBERDING, DIRECTOR, CENTERS FOR
DISEASE CONTROL AND PREVENTION; DR. ANTHONY S. FAUCI, DIRECTOR,
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; AND DR.
JANET HEINRICH, DIRECTOR, PUBLIC HEALTH ISSUES, GENERAL
ACCOUNTING OFFICE
Dr. Gerberding. Thank you, Mr. Chairman, members of the
committee, for allowing me to be here today. What I would like
to do is to frame the discussion about preparedness and why we
need to be prepared for influenza by pointing out the picture
of this year's outbreak investigation status.
[Slide shown.]
Dr. Gerberding. You can see in the first graphic here what
the United States looked like in October when a single State,
Texas, was reporting significant localized influenza activity.
In just a few weeks, all of the red States were showing
widespread activity. And by the end of December, almost the
entire United States was involved in a very large-scale flu
outbreak. Fortunately, as of the end of January, most of the
States now are just showing sporadic or very localized
activity.
But this was a flu season that started much earlier than we
have ever seen, spread faster, and in no time in our history of
surveillance have we ever seen that much widespread activity
across the United States at a single point in time. So it was a
wake-up call. Fortunately, it turned out to be not the worst
epidemic we have had, but a warning sign that further
preparedness efforts clearly are necessary. And I certainly
appreciate Mr. Waxman's remarks about the impending possibility
of a pandemic.
[Slide shown.]
Dr. Gerberding. On the next graphic I have depicted the
1918 flu outbreak and its impact on mortality in the United
States at the beginning of the last century, just to point out
what an extraordinary capability flu does have. This is a
deadly virus, and it is a tricky virus, because it is
constantly undergoing evolution, and that is why we need to get
a new flu shot every year. Usually the evolution is in minor
steps, so the vaccine in 1 year looks pretty much like the
vaccine in the past year. But occasionally we see very large-
scale changes in the virus, and that is really what
traditionally has set off a pandemic.
[Slide shown.]
Dr. Gerberding. On the next graphic I have mapped out over
time how viruses move from animals to humans and create these
pandemic strains. There are 15 types of flu virus. They are all
present in migratory birds like ducks. These avian viruses are
present in nature in ducks; they usually don't cause disease.
Occasionally they move to other species like chickens, and some
of them cause very severe bird flu disease in chickens like we
are seeing in Asia right now.
Human viruses and bird viruses can mix up in pigs, because
pigs are vulnerable to both infections. And sometimes when this
happens their genes get mixed up so a brand new, very novel flu
strain evolves. This is called a re-assorted virus, and when
that virus enters the human population, we have never seen it
before, none of us have immunity to it, and a pandemic can
occur. This has been our concern all along, because this
happens periodically, as I will show you in a moment.
But recently we have also begun to be very concerned about
the possibility of these avian viruses directly moving to
people and then evolving in people to become much more
efficient in their transmission from person to person. That has
never happened, but biologically it is plausible, given how
these viruses evolve.
So we have two mechanisms where we could end up with a
novel strain of a virus that could set off a pandemic.
[Slide shown.]
Dr. Gerberding. On the next graphic I have mapped out over
the past century how pandemics in the United States occurred.
The 1918 virus was an H1 virus, and that caused the very large
spike in mortality that I demonstrated. In 1957 a brand new
virus appeared, an H2 virus, that set off the Asian flu
pandemic. In 1968 the Hong Kong H3 virus first appeared and set
off that pandemic. H1 came back a few years later, it did not
cause a pandemic in people over age 20 because they had some
immunity from the old outbreak, but it did cause a very large
outbreak among people under age 20.
Today we generally have circulating H1 virus, H3 virus, and
influenza B virus in the human population. That is why our
vaccine has to contain three different strains of virus in
order to protect us from what is currently common in our
population.
But up here at the top of the graph I have shown also the
little clusters of bird flu that have emerged and been
transmitted to people over the last several years. This has
happened sporadically before, but since 1997 it has been
happening with a regular frequency. And it is these bird flu
strains that, of course, have our attention right now as their
potential for evolving and becoming more efficiently
transmitted in humans.
[Slide shown.]
Dr. Gerberding. On the next graphic I have just provided a
brief overview of the timeline for vaccine development, because
it is really this timeline that has caused the biggest
challenge in preparation for pandemic flu. As you pointed out,
there are 185 million people in this country who need flu
vaccine. What CDC does in conjunction with WHO and
investigators around the world is constantly sample viruses,
genetically characterize them in our research labs, and
anticipate what might be the next strain.
When we see a new virus pop up, we work with it in the
laboratory with our colleagues in St. Jude's in Tennessee and
in a laboratory in the United Kingdom to try to create the best
possible virus for vaccine. But that takes time, and we have to
get a virus that is safe enough to work with and is able to be
propagated well in eggs, since that is the methodology we are
using. The best possible timeframe from getting the virus and
getting it into a form for vaccination is about 4 months, and
that is a best case scenario.
So we are constantly operating under this very narrow
window of opportunity to get the right virus, manipulate it
genetically to be suitable for vaccination, and then produce
the vaccine that we need. And we are doing this right now in an
egg base culture system, which is a very old fashioned way of
making vaccine, and I think it speaks to the other challenge in
all of this, which is basically the capacity of our
manufacturers to utilize this technology in a fast enough
timeframe to get what we need done.
So the three challenges that Secretary Thompson has asked
us to address at NIH, CDC, FDA, and the other departmental
agencies as we prepare the Department's pandemic planning are:
No. 1, how are we going to get those 185 million people
vaccinated; No. 2, how are we doing to get enough vaccine to
assure that we have the supply we need when we need it; and,
third, how are we going to modernize our vaccine production so
that we can get the job done.
Thank you.
[The prepared statement of Dr. Gerberding follows:]
[GRAPHIC] [TIFF OMITTED] T3723.008
[GRAPHIC] [TIFF OMITTED] T3723.009
[GRAPHIC] [TIFF OMITTED] T3723.010
[GRAPHIC] [TIFF OMITTED] T3723.011
[GRAPHIC] [TIFF OMITTED] T3723.012
[GRAPHIC] [TIFF OMITTED] T3723.013
[GRAPHIC] [TIFF OMITTED] T3723.014
[GRAPHIC] [TIFF OMITTED] T3723.015
[GRAPHIC] [TIFF OMITTED] T3723.016
[GRAPHIC] [TIFF OMITTED] T3723.017
[GRAPHIC] [TIFF OMITTED] T3723.018
[GRAPHIC] [TIFF OMITTED] T3723.019
[GRAPHIC] [TIFF OMITTED] T3723.020
[GRAPHIC] [TIFF OMITTED] T3723.021
[GRAPHIC] [TIFF OMITTED] T3723.022
[GRAPHIC] [TIFF OMITTED] T3723.023
[GRAPHIC] [TIFF OMITTED] T3723.024
[GRAPHIC] [TIFF OMITTED] T3723.025
[GRAPHIC] [TIFF OMITTED] T3723.026
[GRAPHIC] [TIFF OMITTED] T3723.027
[GRAPHIC] [TIFF OMITTED] T3723.028
[GRAPHIC] [TIFF OMITTED] T3723.029
[GRAPHIC] [TIFF OMITTED] T3723.030
[GRAPHIC] [TIFF OMITTED] T3723.031
[GRAPHIC] [TIFF OMITTED] T3723.032
Chairman Tom Davis. Thank you very much.
Dr. Fauci.
Dr. Fauci. Thank you very much, Mr. Chairman, members of
the committee. It is a pleasure to be here with you today, and
thank you for giving me the opportunity to testify before this
committee.
I am going to talk to you for a couple of minutes from the
perspective of the biomedical research endeavor to meet the
threat of emerging and re-emerging diseases in general, but
specifically, for today's purposes, influenza.
[Slide shown.]
Dr. Fauci. This particular map of the world shows just over
the last 20 or so years the number of emerging and re-emerging
diseases with which we have been confronted both in the United
States and worldwide. When we talk about emerging diseases, we
talk about brand new diseases. Some examples are HIV and SARS.
A re-emerging disease is a disease that is an old disease but
that reappears in a different form, in a different geographic
location. We have experienced West Nile virus since 1999, which
is a re-emerging disease; it has been around for a long time.
But perhaps the epitome of the continually re-emerging
infection is influenza, particularly influenza A, because it
has the capability of slightly changing from year to year,
which necessitates our having essentially new vaccines each
year, as well as the possibility and potential to do what Dr.
Gerberding mentioned, about changing so dramatically that it is
essentially a new virus.
[Slide shown.]
Dr. Fauci. And the molecular reason for that is really
rather simple. The influenza virus has a number of genes and
proteins. The two that are used for designation are the
hemagglutinin, which refers to the H, where we get the H3, H1,
H2; and the neuraminidase, which is the N. We have an example
this year of both a shift and a potential drift. A drift is a
very slight change. Our vaccine this year had the H3N2 Panama
strain. What we were confronted with was an H3N2 Fujian strain,
a slight difference, not dramatic, but enough to obviate a bit
the efficacy of the vaccine.
What we are facing now is the potential for a shift where
that antigenicity changes so much that we are really naive to
this, as Dr. Gerberding just mentioned a moment ago. One of the
clear ways of doing that is when a virus jumps species from an
animal to a human, and this is what we are seeing with the H5N1
right now in Asia, jumping from chicken to human in Thailand
and Vietnam, with the potential of going from human to human.
[Slide shown.]
Dr. Fauci. This is a chart of the different countries that
now have clear-cut bird flu, two of which have transmission to
humans, as I mentioned. What is wrong with this picture that is
different from years ago is that it is getting worse and worse
each year. We usually see a chicken virus that jumps to humans
in a very confined location, as we saw last year and a few
years ago. We rarely, if ever, see the extent that we see now
with nine countries. The reason this is important is that the
more chickens that jump to humans, the more humans get
infected, and the more humans get infected, the greater the
probability of the virus changing enough to develop the
capability of going from human to human.
[Slide shown.]
Dr. Fauci. And when that happens, you have the possibility
of a pandemic, as we saw in 1918-1919; whereas, you yourself
said, Mr. Waxman, and Dr. Gerberding also, there were tens of
millions of deaths for the simple reason that the population of
the world was naive to this type of flu. You didn't have the
years, if not decades, of memory of similar viruses that you
were exposed to.
[Slide shown.]
Dr. Fauci. So what are we going to do about it? As part of
the departmental plan for confronting both pandemic and
interpandemic flu, we do the research associated with
understanding the pathogenesis and ultimately the basic
research that will allow us to develop countermeasures in the
form of diagnostics, therapeutics, and vaccines. That is
schematically diagramed on this poster here. I want to point
out one component of it which is really very important, and
that is the revolution over the last decade in genomic
research, which allows us not only to very rapidly sequence the
microbes to give us a good handle on what we are dealing with,
but now an example of what we are calling reverse genetics,
where you have the capability of essentially recreating at the
genomic level a virus of your choice that clips out the
virulence components, but allows the virus to grow very well in
whatever media you choose, be it eggs or a cell culture media.
And that is what we are doing now with the H5N1 to get a seed
virus that could be used for a pilot vaccine.
[Slide shown.]
Dr. Fauci. And on this last poster, this really summarizes
the flowchart of the development of influenza vaccine. It
starts off with isolation of the virus in question. The one we
are concerned with now, as I mentioned, is the H5N1 that has
jumped from chickens to humans. To understand the pathogenesis,
to get the proper sequence, to do the molecular manipulation,
to get it in a seed form to do a vaccine, and then to make
pilot lots and to test those pilot lots in the NIH's network of
vaccine trials unit. All of that synergizes with the public
health aspects of what the CDC continues to do, as well as
other agencies of the Federal Government.
So in summary, the process of preparing for both
interpandemic and pandemic flu is complex and is heterogeneous;
there is research and there is public health. All of these need
to work together to meet these inevitable threats.
Thank you, Mr. Chairman.
[The prepared statement of Dr. Fauci follows:]
[GRAPHIC] [TIFF OMITTED] T3723.033
[GRAPHIC] [TIFF OMITTED] T3723.034
[GRAPHIC] [TIFF OMITTED] T3723.035
[GRAPHIC] [TIFF OMITTED] T3723.036
[GRAPHIC] [TIFF OMITTED] T3723.037
[GRAPHIC] [TIFF OMITTED] T3723.038
[GRAPHIC] [TIFF OMITTED] T3723.039
[GRAPHIC] [TIFF OMITTED] T3723.040
[GRAPHIC] [TIFF OMITTED] T3723.041
[GRAPHIC] [TIFF OMITTED] T3723.042
[GRAPHIC] [TIFF OMITTED] T3723.043
[GRAPHIC] [TIFF OMITTED] T3723.044
[GRAPHIC] [TIFF OMITTED] T3723.045
[GRAPHIC] [TIFF OMITTED] T3723.046
[GRAPHIC] [TIFF OMITTED] T3723.047
[GRAPHIC] [TIFF OMITTED] T3723.048
[GRAPHIC] [TIFF OMITTED] T3723.049
[GRAPHIC] [TIFF OMITTED] T3723.050
Chairman Tom Davis. Thank you very much.
Dr. Heinrich.
Dr. Heinrich. Mr. Chairman, members of the committee, I too
am very pleased to have the opportunity to be here today to
discuss our Nation's preparedness for managing public health
threats such as these large-scale outbreaks of infectious
diseases. Certainly with the SARS outbreak in 2003, this
highlighted the challenges in responding to new and emerging
infectious diseases, and the recent incidents involving Ricin
have raised additional concerns about responding to toxic
substances.
To assist the committee in its consideration of our
Nation's ability to respond to major public health threats, my
remarks will focus on the State and local preparedness, and
Federal and State efforts to prepare for an influenza pandemic,
and my testimony is largely based on the report that we issued
this week.
For the report, we reviewed each State's progress report on
the use of approximately $1 billion of bioterrorism
preparedness funding that was distributed by CDC and the Health
Resources and Services Administration in 2002. The progress
reports covered the period through August 2003.
For our report, we also interviewed State and local
officials in 10 States and several local jurisdictions. In
addition, we updated our prior work on the status of the
national and State plans for responding to an influenza
pandemic.
We found that as of the summer of 2003, all States had made
improvements in their ability to respond to major public health
threats, but no aspect of preparedness was fully addressed. In
the area of disease surveillance, about half of the States
reported having the capacity of receiving and evaluating urgent
disease reports on a 24 hour a day, 7 day a week basis.
However, only a few States reported having the ability to
rapidly detect an outbreak of an influenza-like illness in
their State. Similarly, few States reported making efforts to
strengthen links between their public health and animal
surveillance systems in the veterinary community in order to
monitor diseases in animals that may spread to humans, such as
the West Nile virus.
All States participate in CDC's laboratory response
network, a network of local, State, Federal, and international
laboratories that are equipped to respond to emerging threats.
However, only about half of the States reported they have the
capacity to conduct advanced tests for some of the potential
bioterrorist agents.
Most States reported that funding from CDC allowed them to
appoint an executive director for their bioterrorism program,
designate a full-time person as response coordinator, and hire
at least one epidemiologist for each metropolitan area with a
population of 500,000 or more. Having dedicated leadership and
critical expertise is important; however, the ability to hire
and retain personnel is still a major concern for State and
local health officials who identify work force shortages as a
long-term challenge.
Most States reported that hospitals lack surge capacity to
evaluate, diagnose, and treat a large influx of patients with
an infectious disease. Furthermore, no State reported having
protocols in place for augmenting personnel in response to such
an influx of patients. Another concern is that few States have
regional plans in place that would coordinate the response
across State borders during a public health emergency.
As we reported previously, Federal officials have drafted,
but not finalized, the Federal Influenza Pandemic Plan. In 2000
we recommended that HHS complete this plan, but HHS recently
reported that the plan is still under review. States are
currently developing their influenza pandemic response plans,
but they have had to make assumptions about what the Federal
role during a pandemic will be. It is still unclear, for
instance, whether the private sector, public sector, or both
will have responsibility for purchasing and distributing
vaccines and antiviral drugs during a pandemic. These
assumptions they are making may prove to be incorrect and cause
confusion and disruption of supplies at a critical time if we
actually face a pandemic.
In conclusion, while we wish to acknowledge the many
positive changes since we last appeared before the committee,
and we have documented where States have taken actions to
improve their ability to respond to a major public health
threat, we see that much remains to be accomplished.
I will be happy to answer any questions.
[The prepared statement of Dr. Heinrich follows:]
[GRAPHIC] [TIFF OMITTED] T3723.051
[GRAPHIC] [TIFF OMITTED] T3723.052
[GRAPHIC] [TIFF OMITTED] T3723.053
[GRAPHIC] [TIFF OMITTED] T3723.054
[GRAPHIC] [TIFF OMITTED] T3723.055
[GRAPHIC] [TIFF OMITTED] T3723.056
[GRAPHIC] [TIFF OMITTED] T3723.057
[GRAPHIC] [TIFF OMITTED] T3723.058
[GRAPHIC] [TIFF OMITTED] T3723.059
[GRAPHIC] [TIFF OMITTED] T3723.060
[GRAPHIC] [TIFF OMITTED] T3723.061
[GRAPHIC] [TIFF OMITTED] T3723.062
Chairman Tom Davis. Thank you very much.
Let me thank all of you. I think it was excellent
testimony.
Dr. Gerberding, let me start with you. I noticed the
President's budget submission includes, as Mr. Waxman noted, a
cut of $105 million for State and local preparedness, but there
is a new public health tool called the Bio-Surveillance
Initiative. Does that balance off? Can you explain how that
works? Are we going to be better prepared or would we be better
off restoring the $100 million in addition, or do you have any
thoughts on that? Not to put you on the spot.
Dr. Gerberding. I am used to it.
As we just heard from the GAO, the States still lack the
capacity in all jurisdictions to rapidly detect an emerging
threat, to alert people 24/7 out to the distal nodes of the
response system, and what the President's initiative is
designed to do is to accelerate our capacity to detect events
at the Federal, State, and local level. So what we are doing
with that investment is creating systems that allow us to get
real-time data from a variety of sources and to identify the
emergence of a health threat and immediately communicate that
back. Already we are receiving about 350,000 lab reports a day,
we are getting information from nurse call lines around the
country, we are receiving clinical data from the DOD and the
VA, and we are synthesizing all that information and creating
systems to work with the State and local jurisdictions to
accomplish this detection and response mode much more quickly.
So while there is a reduction in the State-to-State allocation
for these activities, we do have this new investment and this
new tool that we think will organize and orchestrate this on a
much faster timeline than doing it 50 times.
Chairman Tom Davis. OK. Let me ask you, and maybe Dr. Fauci
as well, how effective are vaccines? If you are vaccinated,
does that give you a 99.9 percent immunity? Why do some people
get the flu and others don't when they have the same exposure?
Just kind of a primer. I was a political science major.
Dr. Fauci. Well, that is actually an excellent question
that frequently gets asked. In a year in which the vaccine
matches the circulating strain of flu, in a healthly young
person it ranges from 70 to 90 percent effective. As you get
into elderly individuals, the capability of the vaccine to
protect against the strain in question diminishes considerably,
sometimes as low as 50 percent. And when there is a mismatch,
even though it was only a slight to modest mismatch, as we saw
this year, it sometimes can go down to 30 to 50 percent of
efficacy.
It really varies rather considerably on the health status
of the individual who is vaccinated, and that is why you see it
diminish with age and in people who are immunosuppressed,
people who are on immunosuppressive drugs, people with HIV
infection, people like that; the capability of their immune
system to appropriately respond to a vaccine gets less and
less. But in an otherwise healthy, young individual it ranges
between 70 and 90 percent.
Chairman Tom Davis. And I guess even if you don't have the
vaccine, some people get exposed and don't have many symptoms.
Dr. Fauci. Oh, without a doubt.
Chairman Tom Davis. Because their immune systems are just
strong.
Dr. Fauci. Yes. And there is a range of responses to a wild
type or confrontation with a circulating virus, such that
somebody might get infected and have such a subclinical illness
that they don't even know they are infected. And there is a
whole range of people who have mild illness, moderate illness,
and then there is a very small percentage of people who do
very, very poorly; they get very sick and sometimes life-
threateningly so, and that is usually less than 1 percent.
Chairman Tom Davis. But you can walk around vaccinated, and
there are still other flu strains out there that can nail you.
Dr. Fauci. Oh, absolutely. There is no question about that,
yes.
Dr. Gerberding. If I could just add one thing, though.
Chairman Tom Davis. Sure. Please.
Dr. Gerberding. Because the vaccine really does save lives.
So we don't want to give people the impression that there is no
advantage to vaccination. It is clearly a life-saving
intervention.
Chairman Tom Davis. There are other members who brought
this up, that vaccinations can cause the flu itself, where you
get people reacting that get it and otherwise wouldn't because
their systems respond.
Dr. Gerberding. This is a common misunderstanding, because
sometimes the flu vaccine itself causes an inflammation or a
small reaction. But flu vaccine absolutely does not give you
flu if you are using the inactivated vaccine, because all the
virus particles are dead. The new flu vaccine that came out
this year, that you put in your nose, is an attenuated strain
of virus; it is still alive, and so it causes a very mild
infection that is limited to your nasal tissues. That vaccine
sometimes is associated with fever and some very minor cold-
like symptoms. But none of the virus vaccines actually cause
flu.
Chairman Tom Davis. So there is agreement on that.
Dr. Fauci. There is no question about it. In fact, you
often hear we, as physicians, sometimes hear, I know Dr.
Gerberding and I both have people say, ``No, I got the flu shot
and the next day I got the flu, so the flu shot must have given
me the flu.'' It is physically impossible for that to happen
with a killed virus.
Chairman Tom Davis. And on the nasal side, there was
something on a Web site this year. Was it misleading? I know
there has been some talk that it can cause flu.
Dr. Gerberding. As I said, the virus in the vaccine, the
nasal vaccine, is a very weak virus, and it is temperature
sensitive, so it doesn't grow well at normal temperatures. And
it does not actually cause disease, but the hypothetical
concern is that if you passed even this weak virus on to
someone with a very depressed immune system, as Dr. Fauci was
saying, that it could theoretically cause infection in that
individual. So as a precaution we recommend that people who
receive this very effective FluMist vaccine don't have direct
contact with others who are very immunosuppressed.
Chairman Tom Davis. OK, thank you. I may followup on that,
but it is Mr. Waxman's turn.
Mr. Waxman. Thank you, Mr. Chairman.
Dr. Gerberding, all of us in the Congress appreciate your
hard work and the hard work and dedication of the scientists at
CDC. They are dedicated people, and we commend them for the job
they are doing. I said in my opening statement that I am
concerned that the President's budget does not provide adequate
support for public health. You testified that the new
recommendation to vaccinate children between the ages of 6 and
23 months against flu is an important step in saving lives, yet
the Virginia State health commissioner is going to testify that
the President's budget does not provide adequate funding to
assure States will include the flu vaccine in their childhood
immunization programs.
Are you concerned that the President's budget does not
provide enough funding for the Federal Vaccines for Children
program and for the State grants for vaccination efforts to
assure that children have access to all recommended vaccines,
including the flu vaccine?
Dr. Gerberding. There has been a change in the way the
allocation for vaccines is proposed in the President's 2005
budget. One of the changes is to provide an additional $40
million to stockpile influenza vaccines for children so that we
have an additional supply. And in the Vaccines for Children
line, these pediatric doses would then be available to amplify
the amount of vaccine that we have had in the past. In
addition, that change in allocation ensures that additional
children will be eligible for childhood immunizations who
currently don't qualify under the voluntary program. By putting
more money in the mandatory vaccination program, we actually
will end up with a net increase in the number of children who
can receive vaccines and, in addition, negotiated a much better
price for the diphtheria tetanus vaccine that was too expensive
for many children to receive in the past.
Mr. Waxman. That $40 million flu vaccine stockpile is a
reserve supply, it doesn't really address the issue of routine
vaccination programs. We are going to hear from others,
especially the States, who are going to tell us they feel they
are being short-changed. Are you concerned they might have a
point?
Dr. Gerberding. I am always concerned if the States have a
perspective. One of the things that we are doing in the
department right now is looking at how we can predict what the
utilization will be. We are also going back to the ACIP, the
immunization advisory board, and evaluating this year's flu
situation in children to make sure that our recommendations for
limiting the vaccine to that age group still apply, given the
concerns about an additional burden of illness in children. So
we have to look upon this as a work in progress, and if there
are unmet needs, we will do our best to identify them.
Mr. Waxman. The GAO is going to report that not a single
State has a plan for hospitals to handle an epidemic of at
least 500 patients. We are also going to hear from the Trust
for America's Health that most States and HHS have not
finalized their flu plans, and that only two States have the
capacity to receive and distribute emergency medications.
When will State and HHS pandemic flu plans be finalized,
and how can we close critical public health gaps as quickly as
possible?
Dr. Gerberding. Thank you. As you know, a plan is one
aspect of preparedness, and the formalized big, thick flu plan
is not yet finalized in the department, although I think we do
have the final document together. But there is much more
important work besides a written plan, and we saw with SARS how
rapidly we were able to scale up and develop plans for
containing SARS, and actually, as you will see on the CDC Web
site, the steps that need to be taken at the local level for
managing SARS are the same steps that we would recommend for
flu.
Mr. Waxman. Well, we are going to hear testimony that
additional funding is going to be critical for this to all
happen, and the President's budget cuts over $100 million from
State and local public health preparedness grants. And in his
written testimony today, the Virginia State health commissioner
states these cuts could jeopardize our ability to respond to a
terrorist event, outbreak of an infectious disease, or other
public health threat or emergency.
So it seems to me the States are telling us, even though
you answered Mr. Davis' question by saying that there is money
because of the biosurveillance program, they are saying they
see this all as a cut. If there is a biosurveillance program,
that could increase demand for their funds because there can be
some sensor that will pick up something, they will have to
divert resources to deal with it, and yet we are faced with
these public health emergencies as well.
So do you see that the States vigorously disputing this
point, that the States are wrong?
Dr. Gerberding. As you know, we put about $3 billion into
the States through the various preparedness activities, and we
are constantly looking at the evolution of preparedness
building from a pretty dilapidated public health system, and so
we have to be able to sustain these investments for the long
term to catch up with where we should have been all along.
Having said that, I think that our goal is to achieve a
level of preparedness that would be adequate to protect against
terrorism as well as emerging health threats, and we have seen
some very encouraging examples this year where the investments
really have paid off, with the meningitis outbreak in Chicago,
the hepatitis A outbreak in Pennsylvania.
Mr. Waxman. Well, I am sure the investments are improving,
but if we are not making the full investment we need, we are
not going to get to the point where we must be if we are going
to face a crisis.
I do want to ask one question of Dr. Fauci before we move
on. Experts have said that a bird flu vaccine is urgently
needed. What is the progress on such a vaccine? Should vaccine
companies be producing bird flu vaccine right now?
Dr. Fauci. The process of developing a vaccine for bird flu
that might infect humans has already been launched, namely, the
seed viruses are now in hand to a number of groups, including
the CDC and the NIH. They are being produced and we are
negotiating now for the development of pilot lots that will be
used in phase 1 studies to determine not only the safety, but
what the dosage would be. That whole process of getting a seed
usually takes from weeks to a month, of getting a pilot lot
usually takes a couple of months, and then an additional 6
months to have the vaccine available. So we are already going
in that direction.
We must caution that it is a work in progress, because if
there is a virus that goes from chicken to human, which is what
we are all concerned about, and if it then assumes the
capability of going from human to human, it might change such
that it is a bit different from the original virus that went
from the chicken to the human. So you have to move ahead,
because you can't wait, but you have to keep your eye on what
is evolving out there in the field.
Mr. Waxman. Thank you.
Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much.
The gentleman from Tennessee.
Mr. Duncan. Thank you, Mr. Chairman.
I understand from some of the briefing materials that about
87 million people, or about 30 percent of our population, got
vaccinated this past flu season. Is that roughly correct?
Dr. Gerberding. We don't have the final information yet,
but our best estimate is about 87 million, and that is the
largest number of people we probably have ever vaccinated.
Mr. Duncan. And then we are also told that ordinarily 10 to
20 percent of Americans get contagious respiratory illness
annually. We have said 30 percent got vaccinated, but of the
total population, of the 285 million people we have in this
country, how many people contracted this flu this season?
Dr. Gerberding. It is too early for us to give you the
absolute answer to that, but in general, on an average year it
is between 10 and 20 percent of all people get influenza;
obviously, most of them very mild disease.
Mr. Duncan. And I am not sure exactly how this works. I
understand there were three companies that came up with the
vaccine this season?
Dr. Gerberding. In the United States there are three
vaccine manufacturers that contributed to our supply. There are
other manufacturers around the globe, including companies that
make vaccine for the Southern Hemisphere, which usually has a
little bit of a different influenza profile than the Northern
Hemisphere; and the timing in the Southern Hemisphere is out of
sequence with ours.
Mr. Duncan. And how is this paid for? Because I have seen
programs where they give out free flu shots and then other
places where they charge. Are these companies totally
compensated by the Federal Government or is it part Federal and
part private, or how is it done?
Dr. Gerberding. For influenza immunization, the vast
majority of the program is in the private sector, so it is
administered through health plans and private clinician offices
and so forth. A small proportion is in the public sector. For
those of us in public health, that is the part of the
vaccination program that is the easiest for us to monitor and
to keep track of, but we are developing new systems so that we
will be able to have a much bigger picture of the whole vaccine
supply; where it is, how it is being distributed, who has it
and who doesn't.
Mr. Duncan. And you just said that you sent $3 billion to
the States?
Dr. Gerberding. Over the last 3 years the terrorism
preparedness funds. That is an approximate figure based on what
CDC puts out and what HRSA puts out to the hospital
preparedness component.
Mr. Duncan. But you said that wasn't just for vaccines,
that was for education and all kinds of things.
Dr. Gerberding. That money is for six things: for
surveillance, for planning, for laboratory capacity, for
information technology, for communication, and training.
Mr. Duncan. Well, rough guess, what percentage of that $3
billion would have been spent on the vaccines themselves?
Dr. Gerberding. Very little of that money would be spent on
purchase of vaccines, because that is not what the money is
specifically for.
Mr. Duncan. And the gentleman doctor, I am not sure how you
pronounce your last name.
Dr. Fauci. Fauci.
Mr. Duncan. Fauci? You said that these vaccines were 70 or
80 percent effective in younger people and in older people it
was 50 percent or maybe even less?
Dr. Fauci. That is correct, yes. It varies. The older
anyone gets, even if they are a relatively healthy older
person, as you get older, beyond 60 or so, your immune system
does not respond as robustly as the immune system of a 20 or
30-year-old. So the efficacy diminishes proportionately,
although it varies. There may be older people who have a very
good response and are really quite well protected.
Mr. Duncan. And I read that each year the health
authorities try to pick three strains of the virus?
Dr. Fauci. Yes.
Mr. Duncan. In advance?
Dr. Fauci. Yes. What happens is that, as Dr. Gerberding
mentioned, toward the end of the winter, the CDC, WHO, and FDA
get involved in doing a surveillance of the strains that are
out there, and in the influenza vaccine shot that you and I
get, it contains two As and a B. For example, this year had an
H3N2, which was the Panama strain; it had an H1N1; and it had
an influenza B.
Mr. Duncan. Well, let me ask you this, since my time is so
short. How many strains are there out there that you choose
from to get these three?
Dr. Gerberding. Overall, there are 15 main types of H1s,
three of which are in humans. But the subtypes of those are
infinite. So each little point mutation in the virus can create
a new strain, and we just can't predict.
Mr. Duncan. Because that is what I had heard somebody say
at another time, that there were so many possibilities, it is
almost unbelievable.
Dr. Gerberding. That is absolutely right.
Mr. Duncan. And it says the effectiveness of the vaccine is
dependent on whether the strains picked will be the same
strains to circulate during the following flu season.
Dr. Fauci. There will always be minor strains, but what we
try to do is to make the best guesstimate of what the
predominant strain that will circulate the following season is.
And generally we are right about 9 out of 10 times, 8 or 9 out
of 10 times.
Mr. Duncan. Well, I have some more questions, but my time
has run out.
Chairman Tom Davis. We may do another round, but thank you
very much.
Gentleman from Maryland, Mr. Van Hollen.
Mr. Van Hollen. Thank you, Mr. Chairman.
Thank all of you for your testimony.
Dr. Gerberding, I just want to take this opportunity to
followup on a hearing we had in this committee last October
regarding the future of the Commissioned Corps of the Public
Health Service and the reorganization plan. And I know you
weren't here at that hearing, but at the time we had a survey
from some of the commissioned officers at the CDC which made it
clear that they were not happy with the direction that the
reorganization was taking and, in response to questions, many
of them said that if it was implemented as proposed by HHS,
that they would seriously consider leaving the CDC, because it
had a number of requirements that seemed to be not appropriate
for some of the scientists at CDC, for example, emergency
deployments in areas outside their area of expertise, certain
physical fitness requirements which might not have really been
applicable. And, in fact, Dr. Carmona, the Surgeon General,
said sending officers such as epidemiologists from CDC to
achieve mission objectives that are not consistent with their
specific training and physical capabilities makes no sense.
My understanding is, however, HHS has gone ahead and
implemented the reorganization plan without the changes the
Surgeon General said he wanted to make in that plan, in his
testimony before this committee last October. So my question to
you is, is that in fact the case and what impact is it having
on the Commissioned Corps officers of the CDC? Have you gotten
any feedback from them? And what actions, if any, do you intend
to take?
Dr. Gerberding. I was very concerned about the results of
the survey that you described. We met with Secretary Thompson
immediately thereafter, and he was very adamant that his
intention is to improve the corps and to strengthen the corps
and expand the corps, and in no way does he want to interfere
with the capacity of the CDC Commissioned Corps officers to
function as effective disease detectives. So since that time we
have set up a series of interventions, better ways to
communicate what the Commissioned Corps needs are, and we have
proposed to the department a special track in the Commissioned
Corps for public health officers that is under review right now
that would accommodate the needs of the Commissioned Corps and
still allow the Secretary to fulfill his mission of having a
much stronger and a much more robust Commissioned Corps. So we
would be happy to talk with you about those proposals, and just
to say that there is a lot of dialog going on right now to try
to make this go in the best possible way to achieve the
mission.
Mr. Van Hollen. OK, so HHS hasn't made any final decisions
with respect to the provisions I referred to.
Dr. Gerberding. The last communication we had was the next
round of the draft proposals, and to my knowledge there has
been no formal decision about the overall transformation.
Chairman Tom Davis. If I might intervene. Not to take your
time, but Mr. Waxman and I both sent a letter to HHS expressing
our concerns, and we are waiting for a reply as well.
Mr. Van Hollen. I believe you sent a January letter, and I
just want to make sure that the committee's concerns are being
heard, and I understand your concerns as well. I just want to
make sure they are being heard, and if you can keep us informed
about it.
Dr. Gerberding. Thank you.
Mr. Van Hollen. Because it seemed to have a potentially
very large impact on CDC based on that survey.
Dr. Gerberding. Thank you. I will make sure that the
Secretary hears your comments today. But I will just tell you
right now that I am absolutely confident that he wants this to
work, and he wants this to work right, so his door is open to
us and we are going to work this out.
Mr. Van Hollen. Thank you.
And, Dr. Fauci, it is wonderful to have you at NIH and my
congressional district, so welcome again.
Chairman Tom Davis. OK. Let me go with a few other
questions.
Dr. Heinrich, the best initial defense against public
health threats continues to be, from what I judge from
everybody's testimony, accurate, timely recognition and
reporting of problems. People out there in the field, when
something happens, are letting us know about it. How well
developed are information sharing networks between States and
the Federal Government at this point, and do these networks
protect privacy while seamlessly connecting government at all
levels?
Dr. Heinrich. Actually, in the area of the communication
electronic network, that is one of the areas where I think
there has been the most progress from our reviews. We have
heard from some of the State officials that information seems
to flow best from the Federal level down, as opposed to the
local county through the State up, but those information
systems do seem to be working.
Chairman Tom Davis. OK.
Let me ask Dr. Gerberding, how effectively did CDC
coordinate work with the State and local public health
officials to respond to this year's flu season? Were these
efforts reflective of how you and State and local officials
respond to a greater public health threat?
Dr. Gerberding. Thank you. On December 5th I activated the
CDC's emergency operation center to coordinate our response to
influenza because we recognized with this fast propagation of
the outbreak we needed to have the best possible logistic
support. So we implemented our emergency communication system,
we provided regular updates, we had routine conference calls
with State and local health officers. We did our very best to
provide the ongoing information and then worked with the bi-
directional communications system to try to track vaccine
shortages and redistribute vaccine as indicated. We also
fielded information about the need for pediatric vaccine and
anti-retroviral drugs. Secretary Thompson was able to authorize
some emergency purchases of both vaccine as well as anti-
retroviral drugs for the stockpile, and I think overall we
built on our experience with SARS, monkeypox, and West Nile
virus and continued to scale up and speed up our integration at
those levels.
Chairman Tom Davis. OK.
Dr. Fauci, the purpose of Project Bioshield is to stimulate
companies to develop modern and effective vaccines, drugs, and
devices to protect Americans in the event of a bioterrorist
attack or a public health emergency. Do you think we need
similar incentives to increase production capacities for flu
vaccine manufacturers?
Dr. Fauci. I think we need to appreciate and recognize
that, in general, transcending biodefense, we have a very
tenuous situation vis-a-vis vaccine development because there
are too few companies involved, and the incentives for
companies to make the risky investment in the development of a
vaccine are such that we really are walking on thin ice when it
comes to vaccines in general; and that would apply even to
influenza. In general, I think Bioshield was a very important
step in trying to shore that up and prevent any potential
serious problems in going forward with vaccines and other
countermeasures in biodefense.
That doesn't alleviate the problems that we have in
general, and what we have been having to do is work more
closely with the companies to push even further in advance
development to take away some of the risk that they take,
because if you look at the incentive of developing a product in
which the risk benefit vis-a-vis profit is considerably less
than a drug, for example, that is very widely used, the numbers
speak for themselves. I mean, there is the classic story that
the amount of money made on a single lipid-lowering drug
essentially eclipses all of the vaccines put together. So we
really do have a problem with vaccine development in that
regard.
Chairman Tom Davis. Is there a flu season where it tends to
peak and we talk about a flu season getting ready, and why is
it a certain time? I mean, it is with us all the time, the
virus is present at all times. Is there a particular season,
and why is that?
Dr. Fauci. Well, in our hemisphere, the season generally
goes in the winter.
Chairman Tom Davis. Are you on? See if your mic is on.
Dr. Fauci. Oh, I am sorry. The season in our hemisphere, in
the United States, Canada, etc., generally starts in the early
winter, December, and generally peaks in January, and then
tapers off as you get to February, and usually is gone by
March. That is not necessarily the case in other regions where
the temperature is essentially constant or practically constant
throughout the year. That is the point that Dr. Gerberding made
just a few minutes ago. With this year, the cases that we were
seeing were unusually early, which triggered the response of
people wanting to get vaccinated.
Chairman Tom Davis. Why is it at that time? I mean, is it
the cold weather that brings it on?
Dr. Fauci. It is a combination of things. The most obvious
that we say, and yet there is some scientific softness about
this, but the generally appreciated explanation is that in the
winter months you have people crowded together and indoors
without a lot of good ventilation, so that when you have a
respiratory-born virus, be it influenza or several others, the
possibility of their transmitting from person to person by
aerosolization or droplets increases as more people spend more
time in situations indoors. That is one of the possibilities.
There are also some studies showing temperature and
moisture and other considerations that allow a respiratory-born
pathogen to be able to be transmitted better or not, depending
upon the humidity and depending upon the temperature.
Dr. Gerberding. I would just add one perspective. In this
world of globalization and connectivity and speed, while we
have a flu season here in the winter months, it is flu season
in the summer months in the Southern Hemisphere. So if you
looked at the globe, at any given time of the year there is flu
virus circulating, and that is something that we have to come
to grips with as we see now how these viruses can move so
quickly throughout the world.
Chairman Tom Davis. That is what prompted the question. Why
here do we seem to have a peak season, although I guess people
get it all the time? And we try to see when a strain is
developing, why information is so important is we see something
new developing somewhere; we want to stay ahead of it before it
becomes a much more massive problem.
Mr. Waxman, you had some additional questions.
Mr. Waxman. Dr. Gerberding, CDC and the Health Resources
Service Administration developed critical benchmarks to measure
progress by the States. This is a very important process, but
for it to work the benchmarks have to be meaningful. In
hospital preparedness, one of the critical benchmarks is that
each State must be able to provide initial evaluation and
treatment to 10 adult and pediatric patients at a time in the
entire State. Certainly this is not a meaningful standard for
California, and maybe not for any State.
I am concerned that some of these standards have been set
to correspond to what is achievable under current levels of
funding, not what is needed for true public health
preparedness. This puts the cart before the horse. Is CDC or
HRSA under any pressure to alter critical benchmarks to match
the funding?
Dr. Gerberding. Actually, what we are doing right now is
moving beyond the kinds of generic benchmarks that were
included in the original guidelines, and we are moving to
performance-based benchmarking, where we actually define the
capacities. And specifically with respect to flu, in the 2003
budget allocation we have much more targeted benchmarks that
deal specifically with influenza. But what we would like to do
at this point in time, now that we have had a chance to build
some basic infrastructure capabilities, is to really hone in on
what exactly does it mean to be prepared and how will we
realistically know that. We are working with the State and
local health departments to define those new benchmarks.
Mr. Waxman. Well, Dr. Heinrich, maybe you can comment on
this. Have they thrown out these old benchmarks? Are they no
longer meaningful and, therefore, they are meeting certain
performance standards that match the needs for public health?
Dr. Heinrich. In our review and in our discussions with
State and local officials, overall, people found the benchmarks
quite helpful in giving them guidance as to how to set
priorities, and, of course, each area varies considerably State
by State, and even within State. We did hear many times that
when there were specific numbers attached to benchmarks, it was
not always meaningful. For example, what you just said, for a
State to say that they could manage an influx of 500 people in
a State as large as California.
Mr. Waxman. Well, it is even less than that. Each State
must be able to provide initial evaluation and treatment to 10
adult and pediatric patients to respiratory isolation rooms in
the entire State. Now, my question is, is this a benchmark that
is meaningful health or is it, one, being driven by the
pressure for CDC or HRSA to match the funding and to set the
target so low, the benchmark so low that it is based on the
funding amounts?
Dr. Heinrich. And I don't know what the rationale is for
those particular numbers. When we asked officials at the
Federal level and others, we didn't really get any good
answers.
Mr. Waxman. Well, let us see if maybe Dr. Gerberding can
give us a good answer.
Dr. Gerberding. The benchmark you are referring to is part
of the HRSA grant, and so I am not prepared to explain it to
you in detail, but I would be happy to make sure that you get
the explanation that you are asking for.
Mr. Waxman. In your professional judgment, is that a
reasonable benchmark for HRSA?
Dr. Gerberding. In my professional judgment, the benchmark
should be based on what is necessary to get the preparedness
level accomplished that we have set out to accomplish. We are
staging preparedness, because you can scale up to any level of
threat imaginable, and it is not realistic to expect people to
be prepared for the worst case scenario the first time out, but
we are moving up the scale every single time we put money out.
Mr. Waxman. We can also scale down to something that sounds
absurd simply because the money might not be there. So that is
a concern I raise.
There are concerns that the bird flu that is affecting both
chickens and people in Asia could be a flu pandemic and my
question for you, Dr. Gerberding, is how many doses of vaccine
for bird flu or another pandemic strain could FDA license
manufacturers produce quickly in case of a flu pandemic? And is
this capacity sufficient to meet the public health needs of the
United States?
Dr. Gerberding. Well, that is a complicated question. I
will try to give you a short answer. With the preparation of a
bird flu vaccine, where we are starting a new manufacturing
process with a new product, we are already using reverse
genetics for this and in an emergency would probably be able to
use a tissue-based culture system and only make a single, as
opposed to a trivalent, product. Our manufacturers right now,
based on their current production, could make 270 million doses
of a monovalent vaccine in the same amount of time that we make
the trivalent vaccine.
So 270 million doses is pretty close to the U.S.
population, and that would be an optimistic projection. That
all assumes that timing goes well and that we have the egg
capacity and the other things that we would need to be able to
do this, or that we can quickly get a safe licensable tissue
culture system.
Mr. Waxman. One of the three FDA licensed vaccine
manufacturers produces vaccine for the U.S. market in the
United Kingdom, and this company will testify that in the event
of a pandemic, the United Kingdom may prevent them from
exporting vaccine to the United States. In the case of a flu
pandemic, how can we be sure that this company will be allowed
to export vaccine to the United States? And if not, what impact
would that have on the flu vaccine supply? And what has HHS
done to encourage vaccine manufacturers to produce vaccine in
the United States?
Dr. Gerberding. Well, that is another area of importance.
We recognize that over the years there have been fewer and
fewer manufacturers engaged in vaccine production, and that
creates vulnerabilities. Some years it creates a vulnerability
in terms of the timing of the availability of the vaccine;
other years, like this year, there was a problem with the total
amount of vaccine produced. I think, as I mentioned, the
Secretary has told us that we need to include steps now to
expand the production capability of vaccine in the immediate
sense, but also in the longer-term sense, to really look at
what needs to happen to incentivize manufacturers to be in this
business. And we are assembling, through the National Vaccine
Advisory Committee, this spring a summary, comprehensive, top-
to-bottom review of what needs to be done about this problem at
the Secretary's request. So we will be able to come back to you
with some specifics on that very soon.
Mr. Waxman. Have you looked at the possibility that we
might be barred from exporting from that factory in Great
Britain?
Dr. Gerberding. That is a vulnerability that we are aware
of. We have similar problems with antibiotics at times, and so
that is one of the things that has to be addressed in this
review.
Mr. Waxman. And just one last question for Dr. Fauci. We
are looking at a prospect for a vaccine that would be cell-
based as opposed to egg-based, and it could be then produced in
a shorter time. What is your view of the future of cell-based
vaccine? And if the cell-based vaccine is the wave of the
future, are you concerned that vaccine manufacturers are going
to be less willing to get into the egg-based flu vaccine
market, since the sense is that the technology may become
obsolete? Would this create a problem during the transition?
Dr. Fauci. I believe that it is essential to pursue
alternative methods of producing vaccines. The egg-based method
has been tried and true, and has served us very well. There are
some potential difficulties with that, particularly in a
situation in which a virus may not grow well in the egg or
might actually destroy the egg, particularly if it has
virulence factors for eggs being a bird flu. We can get around
that partially, or attempt to, by reverse genetics, which
essentially clips out those virulence factors that would be
detrimental to the eggs.
But notwithstanding that, we need to do both in parallel,
and that is exactly what we are doing. We are doing research
right now with several of our grantees to try and develop a
cell-based tissue culture approach toward the development of
vaccines. Some of the drug companies are even doing it on their
own.
What I detect in my discussions with the pharmaceutical
corporations is that they are aware that we need to do those in
parallel, and I hope, but I think there will be an easy
transition so that we will have both going and we will be able
to go to one or the other, depending upon the situation.
Mr. Waxman. Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much. Is there anything
else anybody wants to say that maybe you didn't get in or
respond to some other question? If not, great panel. We
appreciate everybody's time, your testimony, and answering the
questions from the members, too.
We will take about a 2-minute recess while we change the
name tags and get our next panel up. Thank you.
[Recess.]
Chairman Tom Davis. I am going to start. I have to swear
everybody in on our next panel. I want to thank our witnesses
for appearing today. We have Dr. Robert Stroube, the Virginia
State health commissioner. Dr. Stroube and I go back many
years. In fact, your late father George helped me launch my
political career back in 1979, when I ran for the board of
supervisors, and then we worked together in Fairfax when I was
chairman of the county board. And we are just very pleased to
have you here today, and very proud of the job you are doing
for the Commonwealth. You will be testifying on behalf of the
Association of State and Territorial Health Officials to
provide an assessment of State and local public health
departments' ability to respond adequately to a public health
threat.
We have Ms. Karen Miller from the National Association of
Counties [NACo], who will provide the perspective from county
and local health officials on preparedness.
We also invited three flu vaccine manufacturers to discuss
vaccine production capacities and pandemic planning. Mr. Howard
Pien, who is the president and CEO of Chiron Corp.; Dr. James
Young, president of research and development at MedImmune will
be joining us. Unfortunately, a representative from Aventis
Pasteur was unable to attend, but the company has submitted
written testimony for the hearing record. And, finally, Dr.
Shelley Hearne, the executive director of the Trust for
America's Health, produced a noteworthy report that provides an
assessment of improvements to the public health system and
remaining vulnerabilities.
We welcome all of you today. We are just really excited to
have you.
It is the policy of the committee that all witnesses be
sworn in, so if you would stand with me and raise your right
hands.
[Witnesses sworn.]
Chairman Tom Davis. Ms. Miller, do you have somebody behind
you who may answer questions?
Ms. Miller. Dr. Susan Allan, who is the health director for
Arlington County, VA.
Chairman Tom Davis. Oh, great, Susan. I am an old
Arlingtonian of Cherrydale. That is where I went to elementary
school.
Ms. Miller. It is still Arlington.
Chairman Tom Davis. I know. Not in my district, but
probably for the better, looking at their voting patterns.
Let the record show that you are here and sworn in as well.
Dr. Stroube, why don't I start with you, and I will move
straight on down the line? And, again, thanks for being with
us.
STATEMENTS OF DR. ROBERT STROUBE, VIRGINIA STATE HEALTH
COMMISSIONER, ASSOCIATION OF STATE AND TERRITORIAL HEALTH
OFFICIALS; KAREN N. MILLER, PRESIDENT, NATIONAL ASSOCIATION OF
COUNTIES, COMMISSIONER, BOONE COUNTY, MO, ACCOMPANIED BY DR.
SUSAN ALLAN, HEALTH DIRECTOR, ARLINGTON COUNTY PUBLIC HEALTH
DIVISION, DEPARTMENT OF HUMAN SERVICES; HOWARD PIEN, PRESIDENT
AND CHIEF EXECUTIVE OFFICER, CHIRON CORP.; DR. JAMES YOUNG,
PRESIDENT, RESEARCH AND DEVELOPMENT, MEDIMMUNE, INC.; AND DR.
SHELLEY A. HEARNE, EXECUTIVE DIRECTOR, TRUST FOR AMERICA'S
HEALTH
Dr. Stroube. Thank you, Mr. Chairman. Mr. Chairman and
distinguished members of the House Government Reform Committee,
I am the State health commissioner for the Virginia Department
of Health and I will be testifying before you today on behalf
of ASTHO, the Association of State and Territorial Health
Officials. I would like to thank the Chair and the committee
members for convening this hearing on a very important public
health topic: emergency preparedness and our current capacity
to respond to an influenza pandemic.
Substantial congressional investment in preparedness for
public health has significantly aided our ability to rebuild
Virginia's public health system. The Health Department in
Virginia has become a 24/7 response agency and is now a key
part of the State's homeland security infrastructure. This
funding is being used to help prepare Virginia's public health
and hospital system for a rapid and effective response to any
event, whether it is bioterrorism, a naturally emerging
infectious disease such as SARS, a new strain of flu, or a
natural disaster such as hurricane. In order for Virginia to
continue with the ongoing critical enhancement of its response
capabilities, sustained funding from Federal grants is
essential.
This funding has enabled Virginia to enhance and improve
public health preparedness and planning, infectious disease
surveillance and investigation, the State's public health lab,
its communication technology, education and training, and
health information dissemination. In addition, it has enhanced
our ability to develop our State's smallpox preparedness
programs and our ability to distribute the Strategic National
Stockpile.
The President's 2005 budget proposal includes a $105
million cut from the CDC preparedness State grant funding.
ASTHO opposes this proposal. Because no State or community is
yet fully prepared, direct funding to the States for
preparedness activities must be maintained at the current level
provided in fiscal 2004 funding. The current proposed cut in
funding would result in significant cuts in both State and
local preparedness activities. The proposed cuts could
jeopardize our ability to respond to a terrorist event, an
outbreak of infectious disease, or other public health threats
or emergencies. At a time when States are being asked to expand
their role in disease surveillance and emergency preparedness,
such a cut will jeopardize their ability to protect the public
we serve.
In Virginia, such a cut in funding will reduce our current
progress toward upgrading and enhancing our communication and
information technologies. Public health technology
infrastructure has faced serious neglect for many years due to
lack of funding. The Federal grant funding has enabled us to
begin to rebuild our vital information technology system, which
is a process that cannot be completed within just the 2 years
that we have had grant funding. Our recent response to
Hurricane Isabel, to SARS, the recent anthrax scare, and the
early flu outbreak have demonstrated the importance of reliable
and redundant communication systems. Once the information
systems are established, they must be continuously maintained
and upgraded as technology evolves. Such a funding cut also
would impact our State laboratory, which still is in the midst
of upgrading equipment to provide the most sophisticated
methods available for rapid detection of biological and
chemical agents. A Federal funding cut could also impact
Virginia's ability to provide the best and most comprehensive
training available for health care providers and emergency
responders on biological, radiological, and chemical agents.
For a State the size of Virginia, new training technologies,
such as distance learning, are essential. Funding cuts could
impact the health department's ability to provide education and
training programs, which are necessary to ensure our response
work force is always knowledgeable about the latest science.
With regard to unspent grant funds, it is important to know
that any delays in spending of grant funding are due to the
difficulties of hiring such a large quantity of highly
qualified staff in such a short period of time. In addition,
large expenditures have now been obligated for upgrades in
highly sophisticated technology equipment. Virginia went to
great lengths to properly research available systems prior to
making decisions about what to procure. We also worked closely
with other State and local emergency responders to ensure that
we made wise purchases. Virginia is ensuring that its funding
is being utilized to purchase technology that will effectively
serve multiple purposes and correspond with its local emergency
response partners' communication systems.
The current influenza season has certainly been a challenge
for Virginia. The Governor, last summer, ordered an aggressive
campaign to encourage flu vaccination in the State. We provided
more than double the number of flu shots that we typically
provide through our local health departments. This year we
administered more than 160,000 doses of flu to members of the
public. During a more typical year, the health department
provides about 70,000 doses of flu vaccine.
While the Advisory Committee on Immunization Practices
recommended that over 185 million people be vaccinated, only
87.1 million doses of vaccine were produced. However, this
season we had an aggressive flu campaign and an early outbreak
of flu. The situation was enhanced by extensive media coverage
and heightened public awareness and demand for flu vaccine. The
result was the available supply was unable to meet the demand.
Public health worked to promote vaccination. Our efforts were
undermined when the supply was inadequate.
In Virginia, many high-risk patients went without vaccine,
parents could not get young children vaccinated, and health
care providers could not vaccinate their staff. Attempting to
prioritize vaccine to high-risk patients was a local health
department nightmare. In some cases security was needed to
maintain crowd control with demanding patients.
The present system of vaccine production and distribution
was incapable of effectively responding to demands placed on it
during the past flu season. While CDC, Virginia, and other
States struggled to redirect vaccine supply, the reality was
that people went unvaccinated.
Today, only three companies produce flu vaccine for the
United States. Two of these companies produce inactivated,
injectable flu vaccine and the third company produces nasal flu
vaccine, which cannot be used for high-risk patients currently.
Congress needs to support the development of a more reliable
vaccine production process. The current system is incapable of
meeting increasing vaccine demands or timely adjustment to the
vaccine formulation. A review of the Nation's influenza program
must include a comprehensive and critical look at all aspects
of the system, including the production and distribution of
vaccine.
Last, I would like to commend the leadership we receive
daily from CDC. Whenever we have any kind of infectious disease
outbreak, CDC provides rapid, clear, and concise communications
and guidance. This communication is provided to the State
through conference calls, through their continuously updated
Web site, and publications such as the MMWR. CDC guides public
health policy and provides critical guidance documents needed
by both State and local health departments. In addition, CDC
provides routine and accessible updates on information during
public events as it becomes available and is a ready resource
to the States through their emergency operation center.
In closing, I wish to thank Congress for the preparedness
funding it has provided over the last 2 years. It has been
essential for rebuilding the public health infrastructure in
this country, but this cannot be seen as a short-term
investment. Decades of neglect of our Nation's public health
infrastructure make continued Federal investments necessary. We
are eager and ready to address any public health emergency that
may emerge in the coming years, but we are looking to you to
ensure that we have the resources we need to protect the health
of our citizens.
Thank you for the opportunity, and I would be glad to
answer questions.
[The prepared statement of Dr. Stroube follows:]
[GRAPHIC] [TIFF OMITTED] T3723.063
[GRAPHIC] [TIFF OMITTED] T3723.064
[GRAPHIC] [TIFF OMITTED] T3723.065
[GRAPHIC] [TIFF OMITTED] T3723.066
[GRAPHIC] [TIFF OMITTED] T3723.067
[GRAPHIC] [TIFF OMITTED] T3723.068
[GRAPHIC] [TIFF OMITTED] T3723.069
[GRAPHIC] [TIFF OMITTED] T3723.070
[GRAPHIC] [TIFF OMITTED] T3723.071
[GRAPHIC] [TIFF OMITTED] T3723.072
[GRAPHIC] [TIFF OMITTED] T3723.073
[GRAPHIC] [TIFF OMITTED] T3723.074
[GRAPHIC] [TIFF OMITTED] T3723.075
[GRAPHIC] [TIFF OMITTED] T3723.076
[GRAPHIC] [TIFF OMITTED] T3723.077
[GRAPHIC] [TIFF OMITTED] T3723.078
Chairman Tom Davis. Thank you.
Ms. Miller.
Ms. Miller. Good morning, Mr. Chairman. My name is Karen
Miller. I am a commissioner in Boone County, MO, and also
president of the National Association of Counties; and, as you
know, NACo is the only organization that represents county
governments at the national level. Additionally, I would
especially like to thank the National Association of County and
City Health Officials, whose expertise I use today in preparing
this testimony.
America's 3,066 counties vary in geographic shape, size,
population, and services they provide, but one common thread is
that they all have an integral role to play in protecting our
communities. Counties are the Nation's ``first responders,''
responding to virtually every emergency situation, whether it
is a flood, an act of terrorism, or an outbreak of disease.
Mr. Chairman, I have one overall message for you today. We
have made much progress in public health preparedness, but we
have along way to go. At the local level, the people who work
diligently on influenza immunization are the same people who
are working every day to improve public health preparedness for
any type of emergency. As the public health threats to which
they must respond increase, we are asking the same people to do
much, much more with resources that still are very limited.
Today, on behalf of the Nation's counties, I urge two actions:
sustained and increased Federal funding for public health
preparedness, and greater systematic attention by Federal
policymakers to the realities of local public health emergency
planning and response.
As this committee has recognized, our communities must be
prepared for any disease outbreak, whether it results from an
act of nature or an act of terror. We have all been concerned
about the potential for widespread influenza, because we have
seen how it can take the lives of our children. We remember the
scares caused by the anthrax attacks of 2001, and we want to be
sure we know what our communities will do if the unthinkable
occurs.
The good news is that our Nation's counties are better
prepared now than they were 2 years ago. The infusion of
Federal funds for building State and local public health
capacities has helped a great deal. The plans that are in place
will serve us well, whether we face an outbreak of influenza or
smallpox.
We have already benefited from improved public health
preparedness, even though there has been no truly catastrophic
event. For instance, although we hope we will never see a case
of smallpox, we have made great progress in planning for mass
vaccination.
In my own county, the work we did last year on developing a
local health alert network, which was aided in part by public
health preparedness grant funding, improved our response to
influenza this year. It enabled us to share current local data
about flu cases and State and CDC recommendations with our
local medical providers. Our new grant-funded regional
epidemiologist created weekly influenza summaries that we sent
out to the medical community via the local Health Alert
Network. This has improved physician reporting of influenza,
which is essential to help us identify any large outbreak. A
regional public health information officer, also hired with
public health preparedness grant funds, serves us and 16 other
counties. This has enabled us to help be more proactive in
educating the general public about flu vaccination and how to
prevent the spread of flu.
However, when my health department, or other local health
departments, need to respond to influenza, or to a requirement
to vaccinate medical personnel against smallpox as we did last
year, we are still using the same staff that carries out
routine public health activities. The number of hours required
to plan and carry out vaccination clinics pulls many people
away from routine duties and those come to a halt. We just
don't have the resources or the staff to compensate for these
demands. Of the approximately 3,000 public health departments
in the country, nearly all are understaffed and underfunded.
What we want you to understand is that we have drawn upon far
more local resources than Federal funds to move forward in the
public health preparedness.
We still have a long way to go. We know that large-scale
influenza or SARS might resurface in any community at any time.
However, we have never had to implement large-scale isolation
and quarantine. In addition, many communities are concerned
that they lack adequate arrangements for what we call ``surge
capacity,'' that is, extra doctors, nurses, epidemiologic
investigators, and others who are not needed all the time, but
would need to be called into service to contain an outbreak and
care for patients in an emergency.
It is essential that the Federal Government remember that
public health preparedness is not a destination that some day
we will reach and then be able to stop. Rather, it is a journey
during which we will improve little by little, day by day and
year by year. We must always be using exercises to test our
abilities and we must always be training new people, adapting
to new technologies, and preparing to address new threats.
Most local health departments had plans for identifying
stocks of available vaccine and reallocating vaccine among
providers in their community. The unexpected demand for flu
vaccine and its subsequent unavailability concerned us because
it required us to change our strategies and our public message
midstream. It pained us greatly when we found ourselves unable
to offer vaccination to all who asked, particularly because the
FluMist vaccine that remained available is unsuitable for
children and high-risk groups on whom we focus our service.
There were approximately 70 counties in my State alone that
experienced a flu vaccine shortage this year. Overstocking,
though, is way too costly.
Public health requires good collaboration between Federal,
State and local governments because each has an important,
unique role to play. The fact remains, though, that disease
outbreaks don't occur in States; they occur in communities. It
is our counties and cities that bear the greatest burden for
response. In addition, it is essential to understand that
public health preparedness at the local level does not involve
only our public health departments, it is an overall emergency
management system with all the public and private partners.
In closing, I would like to reemphasize the need for
sustained and increased Federal funding for public health
preparedness and greater systematic attention by Federal
policymakers to the realities of local public health emergency
planning and response. You know, the best vaccine and
surveillance in the world won't save any lives if there is no
one at the local level to give the vaccine to the people.
Again, Mr. Chairman, I thank you for the opportunity to
testify before you today. I would be pleased to answer any
questions you may have.
[The prepared statement of Ms. Miller follows:]
[GRAPHIC] [TIFF OMITTED] T3723.079
[GRAPHIC] [TIFF OMITTED] T3723.080
[GRAPHIC] [TIFF OMITTED] T3723.081
[GRAPHIC] [TIFF OMITTED] T3723.082
Chairman Tom Davis. All right.
Dr. Pien from Chiron. Thank you very much for being here.
Mr. Pien. Thank you, Chairman Davis and Mr. Waxman, for the
opportunity to appear today.
Drs. Gerberding and Fauci have provided the committee with
an excellent characterization of this past flu season. I would
just like to emphasize one point. Over 80 million Americans
were vaccinated this past season, probably the highest ever.
This is a significant public health milestone, for which the
men and women working for public health should be recognized.
I would like to convey three key messages to this
committee: one, Chiron is committed to meeting demand for flu
vaccines in the United States; two, raising demand is key to
increasing supply in both the normal and the pandemic flu
seasons; and three, public-private partnerships are fundamental
to increasing the country's preparedness for the normal and the
pandemic flu seasons.
To my first point, our commitment. Chiron invested $878
million this past July to acquire the English company
PowderJect, and the principal driver was the Fluviron and our
flu vaccine business, of which 90 percent is in the United
States. Over the last 4 years, we have tripled our capacity to
38 million doses for the U.S. market in 2003, and in 2004
Chiron plans to produce 50 million doses, a 30 percent increase
over the prior year. We will shortly break ground on a $100
million new bulk manufacturing facility. Chiron is investing in
bringing innovation to the U.S. market. This month we plan to
file an IND application for our cell culture flu vaccine. Cell
culture, as you heard, is viewed by many as one of the best
ways to defend against a possible future pandemic.
To my second point, demand and supply being intertwined.
Demand for vaccines drives increased supply and, therefore,
steadily increasing demand in normal or interpandemic seasons
is key to the preparedness for a pandemic. Put another way,
reliable vaccine supply in a pandemic situation is dependent
upon steadily increasing vaccine demand in the interpandemic
seasons.
In the short-term, a government guarantee to create a
strategic reserve may increase consistency of supply, but only
if it does not undermine the current private sector
distribution system and the public health distribution system
at the different levels of the government and, more
importantly, does not undermine the motivation of the private
sector to invest in product and technology innovation. Public
health interest is therefore best served by achieving the
Healthy People 2010 goal of vaccinating 150 million people
every year. This will reduce the need for the reserve over
time.
And this brings me to my third point, the public-private
partnership. Public-private partnership is key to raising
demand and increasing pandemic preparedness. The Health and
Human Services agencies must be fully funded to continue their
leadership role in these activities. Strengthening our public
health infrastructure to increase immunization rates in the
interpandemic years is the single most important initiative
today to prepare for tomorrow's pandemic.
To maximize the country's preparedness for a pandemic,
Chiron believes that the Congress, the administration, and the
private sector must work together on three things: one,
expediting the already existing scientific collaborations
between the private sector and the scientists at the NIH to
develop new vaccines; two, defining a pathway for speedy
regulatory approval of a vaccine for the pandemic season; and
three, clarifying the financing and the indemnification
mechanisms now to ensure rapid initiation of production before
the pandemic arrives.
A pandemic flu is a menacing threat to the Nation's health.
Chiron pledges to be part of the solution. In the event of a
pandemic, Chiron will cease production of our trivalent vaccine
for the normal season and transition to a year-round production
for a monovalent vaccine. Chiron will aim to triple the number
of doses produced, subject to egg availability. Fifty percent
of our output would be from our FDA licensed facility in
Liverpool. Once Chiron's cell culture flu vaccine is approved,
capacity will be expanded even further. Cell culture will
eliminate egg supply as a bottleneck to speedy production.
My conclusions are therefore threefold: Chiron has invested
heavily in the flu arena and in the public health interest of
our Nation; Chiron is committed to bringing cutting-edge
technologies to the United States to alleviate the threat of a
pandemic over time; Chiron has been and shall continue to be
part of the vibrant public-private partnership in vaccinology,
which is essential to the Nation's long-term health.
On behalf of Chiron, thank you very much for the
opportunity to express these views.
[The prepared statement of Mr. Pien follows:]
[GRAPHIC] [TIFF OMITTED] T3723.083
[GRAPHIC] [TIFF OMITTED] T3723.084
[GRAPHIC] [TIFF OMITTED] T3723.085
[GRAPHIC] [TIFF OMITTED] T3723.086
[GRAPHIC] [TIFF OMITTED] T3723.087
[GRAPHIC] [TIFF OMITTED] T3723.088
[GRAPHIC] [TIFF OMITTED] T3723.089
[GRAPHIC] [TIFF OMITTED] T3723.090
[GRAPHIC] [TIFF OMITTED] T3723.091
[GRAPHIC] [TIFF OMITTED] T3723.092
[GRAPHIC] [TIFF OMITTED] T3723.093
[GRAPHIC] [TIFF OMITTED] T3723.094
[GRAPHIC] [TIFF OMITTED] T3723.095
[GRAPHIC] [TIFF OMITTED] T3723.096
[GRAPHIC] [TIFF OMITTED] T3723.097
Chairman Tom Davis. Dr. Pien, thank you very much.
Dr. Young.
Dr. Young. I am really happy to address the committee.
Chairman Tom Davis. Well, we are happy to hear you.
Dr. Young. As you know, I am president of research and
development at MedImmune, which is a biotech company located
just north of here in Gaithersburg, MD. Today's topic is of
particular interest to me, not only because of my relationship
with MedImmune, but because I am actually a flu virologist by
training.
As you may know, MedImmune manufacturers the new intranasal
flu vaccine FluMist, which was licensed by the FDA in June
2003. FluMist, in addition to being the first intranasal
influenza vaccine available in the United States, is a live
attenuated vaccine that provides immunity both systemically,
throughout the body, as well as in the nasal passages, where
the virus actually enters the body.
Today I would like to share with you our opinion on what
the most recent flu season has taught us about the United
States' ability to protect its citizens against flu and, most
importantly, about the country's ability to be prepared in a
pandemic situation. Our thoughts are based upon our experience
with FluMist in its first year of commercial availability.
After 30 years of development, costing approximately $1
billion, and three FDA Advisory Committee meetings, FluMist was
finally licensed for the very limited population of healthy
individuals aged 5 to 49 years. Because FluMist licensure
occurred late in the influenza manufacturing cycle, we planned
for a limited launch and manufactured at risk about a quarter
of our total production capacity of 20 million doses of
vaccine. Our manufacturing for the current influenza virus
season was virtually flawless, making approximately 5 million
doses of FluMist available to the consumer as early as
September, well ahead of this year's early influenza season. Of
these 5 million doses, about 65,000 doses were donated by our
business partner, Wyeth, to college campus vaccination
programs. Further, up to 3 million doses were made available
for purchase by CDC at a discounted price of $20 a dose, a
price at which, I might add, would require us to sell more than
8 million doses just to break even financially.
Unfortunately, close to 4 million of the 5 million doses
remain unused to date, and will be destroyed at the end of this
year's influenza season. Thus, in spite of MedImmune's best
efforts to work proactively and cooperatively with public
health authorities to bring to the market the first innovation
in influenza prevention in more than 50 years, there were 4
million lost vaccination opportunities in this year's influenza
season, which hit early and hard, and challenged the U.S.
vaccine supply and distribution systems.
As such, as we analyze our initial ``very disappointing''
experience as a flu manufacturer, one of the options we are
considering is whether we should remain in the vaccine business
or whether we should ``cut our losses and get out now'' rather
than face the overwhelmingly difficult regulatory landscape of
bringing new and more effective vaccines to the marketplace. On
our part, to simply achieve parity with the approved labeling
of the old-line, inactivated vaccines, we must spend at least
an additional $200 million to achieve safety and efficacy
standards the other vaccines were never required to achieve, or
have ever independently proven for that matter. This double
standard is more than enough reason to cause new manufacturers
pause before entering the vaccine business, and our very public
experience this season will most certainly have a chilling
effect on others who are considering entry into this business.
What were some of the factors that contributed to the lost
opportunities for vaccination? First, demand for the influenza
vaccine is strongly influenced by policies set by the Federal
health authorities. Currently, influenza vaccine
recommendations primarily target persons who are less than 2
years of age or more than 50 years of age, or who have
underlying medical conditions that put them at high risk for
complications due to flu. However, the burden of influenza
illness is significant in healthy persons who fall outside
these targeted age groups, and in otherwise healthy
unvaccinated school-age children who serve as vectors for
transmission of the influenza to their families and to high-
risk individuals with whom they are in contact. In fact, if you
look at the flu season thus far, from October 2003 through
February 2004, 121 influenza-associated deaths among children
less than 18 years of age were reported by the CDC; 49, or 40
percent, were 5 to 17 years of age, and 95 of the children, or
79 percent, had no underlying medical conditions.
Therefore, MedImmune believes that the existing narrowly
targeted influenza vaccine recommendations are woefully
inadequate and must be expanded, and that influenza vaccine
should be universally recommended for all Americans. This would
further the objectives of influenza prevention, ensure
continued development of new, innovative vaccines, and ensure
availability of adequate supplies for annual and pandemic
influenza seasons. Specifically, a universal recommendation
would drive the demand for routine annual vaccination, which in
turn will provide the impetus on the part of vaccine
manufacturers to increase their production capacity to meet
routine demand. This increased capacity will enable
manufacturers to better respond to influenza not only on an
annual basis but also in the event of a pandemic which would
severely challenge existing vaccine capacity and the vaccine
delivery infrastructure.
Recommendations by the public health authorities are
necessary, but not sufficient, to ensure adequate vaccination
of the American public. Federal authorities need to make the
public aware of the significant burden of influenza in all
populations, both healthy and high-risk, and must
enthusiastically endorse new, innovative vaccines as they
become licensed and available.
Another factor that contributed to lost opportunities for
vaccination in the current influenza season was the
misperception that FluMist could cause influenza, rather than
prevent it, as it had just been approved by the FDA to do so,
driven in part by erroneous information provided by public
health authorities in public statements and on government Web
sites that clearly stated, ``that FluMist can cause the flu.''
While the statement on the Web site was ultimately changed, it
was not changed until after the media ran with the erroneous
information. These statements created damaging misperceptions
of FluMist and its benefits, and most certainly reduced the
number of people protected against this year's flu epidemic
that included the virulent mismatched Fujian strain.
``Accurate'' educational materials from our public health
officials are paramount to successfully sharing the benefits of
vaccination to the general public and achieving broad
immunization against the flu.
How is MedImmune contributing to the efforts to prepare for
a pandemic threat? First and foremost, we have already made a
considerable investment, to the tune of $1 billion, to overcome
the extraordinarily high regulatory hurdles facing new vaccines
in order to make available an important new option for flu
vaccination. Second, should we ultimately choose to remain in
the flu vaccine manufacturing business, we will undertake the
financial burden of spending hundreds of millions of additional
dollars to hopefully expand our indication to include persons
younger than 5 and older than 49 years which, if we succeed in
doing, will in turn hopefully increase the demand for FluMist
that will then justify increasing our manufacturing output to
full capacity. Third, we are working proactively with Federal
authorities to develop and test a FluMist vaccine for use in a
pandemic situation. And, fourth, we have worked closely with
the World Health Organization to make MedImmune's intellectual
property in the area of reverse genetic engineering available
for development and testing of inactivated pandemic vaccines.
So in conclusion, the core of my message to you today is
that in 2004, in the wealthiest and most powerful country on
Earth with the world's best health care system, it should be
unacceptable to all of us that more than 100 American children
and countless elderly have recently died from a completely
preventable disease. Importantly, this year is not unique.
Every year 36,000 Americans die from influenza. The best way
for us to be prepared to prevent this from happening in the
future, as well as to help make sure we are prepared to deal
with a pandemic situation, is to have the current flu
vaccination recommendations expanded to include all Americans,
especially expanded to include that all healthy children be
vaccinated against the flu.
Thank you very much for the opportunity to present today.
[The prepared statement of Dr. Young follows:]
[GRAPHIC] [TIFF OMITTED] T3723.098
[GRAPHIC] [TIFF OMITTED] T3723.099
[GRAPHIC] [TIFF OMITTED] T3723.100
[GRAPHIC] [TIFF OMITTED] T3723.101
[GRAPHIC] [TIFF OMITTED] T3723.102
[GRAPHIC] [TIFF OMITTED] T3723.103
Chairman Tom Davis. Thank you very much.
Dr. Hearne.
Dr. Hearne. Good morning. I am Shelley Hearne with the
Trust for America's Health, which is an independent
organization working to prevent epidemics and protect people.
And thank you, Chairman Davis and Mr. Waxman, for holding this
important hearing. It is certainly a timely one. Just last week
we were reminded, with the ricin scare on Capitol Hill, as to
how vulnerable we are for many health threats. Fortunately, no
one was killed in this incident, at least this time, but it
could have been worse.
One of the things that happened in the anthrax event of
2001 was the rampant scare around the country, which
overwhelmed our public health system. That could have happened
here with ricin, and if it had we would have been in worse
shape. In part, public health is not prepared for a variety of
health threats. Just take a look at the public health
laboratories. Most labs cannot test for ricin, and the majority
of them do not have a chemical weapon response plan.
So I know we are at an influenza hearing, and you may ask
me what has this got to do with the flu. It is actually
everything. One of the things we certainly know is that mother
nature can rival the best of terrorists out there. We have had
35,000 people routinely die from the flu, and if a pandemic
came along, we certainly learned this in 1918, it can kill
hundreds and thousands of more people.
So is it possible to prepare for the threat of bioterrorism
and at the same time to effectively prevent, contain, and
reduce an influenza pandemic? Unfortunately, it is not the kind
of public health system that we currently have today, but I
would argue is just the defense system that we need. However,
America is very far away from reaching that goal.
In December, our organization released a report, ``Ready or
Not? Protecting the Public's Health in the Age of
Bioterrorism.'' We found that 2 years after the September 11th
attacks, and almost $2 billion in new Federal funds, we have
made a lot of progress in preparing for public health, and that
has been echoed certainly with the panels today, but there is
much more that needs to be done.
For example, we found that CDC and the majority of States
do not have pandemic flu plans. This, coupled with minimal
oversight of Federal and State strategies, shows a failure to
translate our concern about bioterrorism into a comprehensive
strategy for public health preparedness. Another major finding
is that only two States were prepared to distribute and
administer emergency vaccination or antidotes from the
strategic national stockpile. And while significant
improvements have been made in the labs, only six States report
that they have sufficient facilities should a major public
health emergency occur.
Finally, our report revealed that since the September 11
attacks, two-thirds of the States have cut their State public
health budgets. And now the President's 2005 proposed budget
threatens to compound the impact of those cuts by slashing
support for State programs. As has been noted before, this
includes cutting the State and local bioterrorism preparedness
by $105 million. Overall, CDC is facing a 3 percent budget
reduction, just at a time when we need this agency to be even
stronger.
To stop the hemorrhaging of the Nation's public health
infrastructure, we are recommending a series of ``fixes'' to
move us toward that modern system with the capacity to fight a
multitude of hazards. Rather than concentrating solely on
bioterrorism or responding to each ``disease du jour'' crisis,
public health preparedness efforts must be focused on all
hazards. We need to simultaneously address the potential for
biological, chemical, radiologic, and natural disease
outbreaks. TFAH is recommending that the CDC authorize States
to use Federal preparedness funds to support an all-hazards
approach. CDC must work with the State and local health
officials to define measurable and mandatory preparedness
standards. State or local governments must demonstrate to CDC
that core public health funding levels are met, thereby
ensuring the maintenance of effort. We believe that Congress
should make a long-term investment toward biosecurity and
authorize an independent review to determine whether current
expenditures are sufficient.
Let me add that the Trust for America's Health conceptually
does support the President's Bio-Surveillance system and also
upgrading the Bio-Watch Program, but we do not believe it
should come at the expense of funding for State preparedness
initiatives, which have been cut by 11 percent. We also endorse
increasing the discretionary programs in the public health
service by 12 percent. At a time when U.S. health care spending
averages about $1.7 trillion, we believe that public health
programs that prevent, control, and treat disease are essential
to reducing America's health care bill.
Last, we recommend that Congress, in consultation with the
President, convene a summit to develop a cohesive national
approach to public health protection. We need a blueprint for
the 21st century, and the summit should address all threats to
our Nation's health, including chronic diseases, infectious and
animal-born illnesses, food safety, and terrorism. Whether it
is anthrax or the avian flu, public health defenses must be
fortified, not forfeited. To do otherwise would guarantee only
chaos and a staggering loss of life should a public health
emergency occur.
Thank you for the time and for being part of this public
policy debate.
[The prepared statement of Dr. Hearne follows:]
[GRAPHIC] [TIFF OMITTED] T3723.104
[GRAPHIC] [TIFF OMITTED] T3723.105
[GRAPHIC] [TIFF OMITTED] T3723.106
[GRAPHIC] [TIFF OMITTED] T3723.107
[GRAPHIC] [TIFF OMITTED] T3723.108
[GRAPHIC] [TIFF OMITTED] T3723.109
[GRAPHIC] [TIFF OMITTED] T3723.110
Chairman Tom Davis. Thank you all. Thank you all very much.
Let me start, Dr. Young, with you. Four million doses were
destroyed last year. Was that the effect of the fact that the
target population, those under 5 and over 50, that your doses
were not recommended for them, or do you think it was the
misinformation that was put out on some Web sites, or a
combination? I mean, clearly those doses could have been used
by people between 5 and 50, instead of some of the other doses
that were used from other areas, and the reallocation we would
have had, in theory, I would think, 4 million more doses
available to people and might have saved some lives.
Dr. Young. Absolutely. I think there were a number of
factors that contributed to that. But it wasn't without our
trying to get the vaccine out. We actually had discussions with
the CDC in December about giving them a million doses, take
them free; we are going to throw them out anyway. Take it free,
you can have it. They said, we can't use that many doses; maybe
we could take 250,000 doses. They never came back and took
those doses from us. But we tried our best.
Chairman Tom Davis. I bet you, Dr. Stroube, and Mrs. Miller
can use them in your areas, right? I mean, I think you hit the
problem in terms of the distribution of this. Maybe we didn't
see the problem at that point, either, developing the way it
developed.
Dr. Young. It was actually the day before Christmas, well
into the epidemic.
Chairman Tom Davis. Keep going, I didn't mean to interrupt.
Dr. Young. No, I think there are other issues about
misperceptions, misconceptions, the public health authorities
not getting behind this new innovative vaccine. You even heard
today talk about how the inactivated vaccine, it was your
question, is only about 70 to 90 percent effective when the
strains are matched, only about 30 to 50 percent effective when
the strains are mismatched. We have data in our package insert
from a clinical trial we did in children that the first year of
the vaccine, when tested in those kids, was 95 percent
effective. That was when the strain was matched. And the second
year, when it was not matched, 87 percent efficacy.
Chairman Tom Davis. Do you think the nasal is more
effective?
Dr. Young. It is an afterthought of the public officials to
talk about that vaccine. It is a great vaccine, yet it is sort
of in the category of hand washing.
Chairman Tom Davis. Just to give you your day here, do you
think the nasal is better than the ordinary vaccine, more
effective for the target populations that you are looking at?
Dr. Young. We haven't done head-to-head trials. In fact,
those trials are underway right now. We actually expect to
unblind a couple of trials in a couple of weeks, and we plan on
doing another head-to-head trial. All I can tell you is we have
the data in children that shows that it is between 80 and 96
percent effective. I don't know that such data exists to show
that kind of efficacy with the inactivated vaccines.
Chairman Tom Davis. The only thing I can say is we have
three producers of flu vaccines, and if you go out, it makes it
a lot tougher.
Dr. Young. Well, it is hard to justify staying in the
business and hemorrhaging money left and right.
Chairman Tom Davis. Oh, I understand. Let us continue to
work.
Dr. Pien, let me ask you. Of course, you are in the
business as well. The one thing that concerns us is not
anything that you are responsible for, but that is if there is
a pandemic around the globe, the fact that your manufacturing
sites are in Britain. Is there any way that you have to serve
Great Britain or Europe first, and not America, that would
limit your ability to disburse those?
Go ahead and answer that, and then I have another followup.
Mr. Pien. Mr. Chairman, I would say that this is really a
subject of some speculation. We have no knowledge that the
government of Great Britain would actually restrict the flow of
the products. And all we can do, of course, knowing that this
is something outside of our control, if it should arise, is to
do our best to increase the total production capacity and make
the investment to enable it, and that is both in terms of the
conventional egg-based technology as well as flu cell culture
flu, as I mentioned before in my testimony.
Chairman Tom Davis. I think it is to our advantage to keep
everybody in business.
How much does it cost to put a dose together in each case,
once the basic research is done, then to develop the dose and
decide how much you are going to do? You get some economies of
scale there, but this year we fell behind because it takes a
period of time, I guess, to work a batch up. Is that the
correct understanding?
Dr. Young. Yes, that is correct. By the time you actually
get the strains, optimize the growth of the strains in the
eggs, and then produce, test, have the FDA review and release
the product, it is many months, upwards of 6 months or more.
Chairman Tom Davis. But once you have gotten one batch
done, isn't it cheaper and faster to do the second? You don't
have to go back and do basic research.
Dr. Young. No, you don't have to go back and do basic
research, but the timeline for production, testing, and release
is the same for every batch. Now, in terms of the cost, I can
tell you that the cost per vaccine is driven in large part by
the level of manufacturing you are doing. For us to just turn
on the lights in our plant costs $60 million, if we don't even
make a single dose of vaccine. And until we actually get up to
the point where we are above 4 or 5 million doses at the
current retail price, we don't make a single dime on the
product until we are above that; and you don't get down into
really reasonable margins until you are up in the range of 15
to 20 million doses of production. So there is a certain fixed
amount of cost that we have no matter how many doses we
produce.
Chairman Tom Davis. But the economies of scale mean the
more you produce, the cheaper, basically.
Dr. Young. The more you produce, the cheaper it is.
Chairman Tom Davis. Is that the same?
Mr. Pien. I would generally concur with Dr. Young's
comment, except to amplify a few points. First of all, you have
to make ongoing capital investments to keep up with the ever-
rising standards of quality control which the FDA insists on,
and has the right to insist on. One of the reasons that we are
making this $100 million investment is precisely for the reason
of wanting to bring state-of-the-art capacity to the buildings
and the machinery and so on, such that as the standards rise
for quality control and quality assurance, we make the products
that meet those standards.
I would also say that there is a general perception that
the vaccines are probably less profitable than pharmaceutical
products. I think the real reason for this is because every
year you have to make new products, and every vaccinee, as it
were, is a new patient; there is no refill as you would have
for any hypertensive, for example. So these are issues that do
contribute to profitability.
I think most of us who are in the vaccine business, and are
remaining in the vaccine business, understand that it is part
of our social covenant that if we have the technology, we have
the know-how, vaccinology is one of the most important ways
that medicine can make a contribution to human health care and
to the country's overall protection.
Chairman Tom Davis. What is the shelf life of an average
dose? Dr. Young, you talk about destroying maybe 4 million
doses. Is that because they are not usable in the next year?
Dr. Young. Yes. Actually, the shelf life is mandated by the
FDA that it expires on June 30th, after the season, so that
there is no misuse of the wrong vaccine the following season
after the strains have changed.
Chairman Tom Davis. OK, that is the FDA's ruling.
Dr. Young. That is correct.
Chairman Tom Davis. But as a practical matter, if you were
to put this in a refrigerator and store it, would it still have
potency 5 years later if that strain came back?
Dr. Young. You would need to store it, in our case, because
of a live vaccine, you would need to store it frozen at very
cold temperatures, and it has a very long shelf life. But the
problem is, as you heard from Dr. Fauci, the strains must be
updated every year for the ones which are in circulation, so
this year's vaccine probably isn't going to be very effective
next year.
Chairman Tom Davis. No, it wouldn't be, but 5 years from
now it could come back, couldn't it?
Dr. Young. Usually that doesn't happen. It is very rare
that the same strain will actually reemerge back into the
population, because everyone is immune to it. They have already
seen it, so the virus is tricky enough to figure out that the
only way it can continue to circulate in the population is it
has to change to the point where no one's prior immunity can
protect them against that strain.
Chairman Tom Davis. Even if you have a regional outbreak
here, that is just the way it works.
Dr. Young. That is just the way it works.
Chairman Tom Davis. OK. I understand that.
Dr. Hearne, in your testimony you said States are
experiencing a shortage of trained public health specialists
and epidemiologists. How serious is this crisis?
Dr. Hearne. Well, it is actually getting worse because we
are finding that the pipeline doesn't exist for many of the
epidemiologists or technical staffers, particularly in Virginia
which has built one of the top labs in the country, but is
seeing problems with work force and the ability to pay highly
skilled, highly trained people. That is just one area of the
gaps that we are seeing. Certainly there have been improvements
in communications in some of the other areas, but there are
still also gaps in making those labs even better, doing some of
the better disease surveillance; number of holes that continue
to need to be filled.
Chairman Tom Davis. OK.
Dr. Stroube, do you have any thoughts on that?
Dr. Stroube. Well, we have been fairly lucky. The lab is a
little bit harder to do because you are looking usually for
Ph.D.s that are really state-of-the-art, and there is a demand
for those. In finding epidemiologists, we actually created 140
new positions in the health department using the Federal money
on it, and we put an epidemiologist in every health district in
the State, we have 35 of them, and planners. And we had some
difficulty recruiting, but we have been fairly successful in
doing that. Part of it, we are close to a lot of public health
schools and we have a fairly attractive place to recruit people
in, so we have done pretty well in trying to recruit people.
But that is a long-term consideration we have been thinking
about, and we have been working with public health schools and
trying to get more people trained in the way we need them.
Chairman Tom Davis. You also mentioned in your testimony
that not all of the Virginia health care workers were immunized
this year with the flu vaccine. I guess we ran out of it
through the process?
Dr. Stroube. We ran out in December, just suddenly. We were
going great guns. Like I said, we put a lot of emphasis on flu
this year, and part of it was to be prepared for SARS. It is
hard to distinguish flu from SARS, so the more people we have
immune to flu, the easier the job dealing with SARS, we thought
it would be. So we really put a lot of effort into that and we
started immunizing everybody in the health department, nursing
homes, hospitals, and really pushed hard on that.
Chairman Tom Davis. Well, let me ask you and I will ask Ms.
Miller and also Dr. Hearne. We really are not ready for prime
time if you get a pandemic at this point, is what I gather from
the first panel and this. Obviously we are making strides, we
are getting better each year we get a test, but is that fair to
say?
Dr. Stroube. Well, I think the biggest problem is vaccine
availability on it. For 3 out of the last 4 years we have not
had adequate flu vaccine supplies; it has either been late due
to manufacturers dropping out, and we just haven't had the
material that we need to be able to enact a pandemic flu plan
to get people to do that. Until we have the flu vaccine, plans
aren't really effective.
Chairman Tom Davis. Did you use any of the nasal vaccine?
Dr. Stroube. We used some of the nasal.
Chairman Tom Davis. For part of the population?
Dr. Stroube. For part of the population. It started
becoming available to us at the discounted price later in the
game on it. Part of the problem we have with that, we have
health departments all across the State, and as Dr. Young said,
you have to maintain that at a very low temperature, which is a
little hard for us to do in distribution systems.
Chairman Tom Davis. But we have to get better at it,
obviously, the way you are going.
Ms. Miller, do you have any comment on that?
Ms. Miller. I would just comment that local governments
have a limited amount of dollars to buy vaccine with, and so I
don't know what the cost is between the two differences, but I
would like to ask Dr. Allan if she could just comment on that,
if that had an effect on why the FluMist was not used
effectively.
Chairman Tom Davis. Sure. We have sworn her in. Let us hear
from her.
That will be my last question, then I will yield to Mr.
Waxman.
Dr. Allan. At the local level, the implementation of an
expanded influenza vaccine program this year was a real
challenge. The vaccine supply issue has been a concern for
several years, as Dr. Stroube mentioned. Beyond that, though,
we ended up putting twice as much staff time into doing the flu
vaccine program this year as we normally do, and I can't
frankly tell you whether that was a success or not from a
public health perspective, because those staff were doing
influenza vaccines which needed to be done, instead of doing
care to pregnant women or routine other vaccines to children or
investigating hepatitis, which also needed to be done, because
we do not have any cushion, any expansion in our staffing. So
to hit a surge like something like influenza means that we are
stopping other things that are also affecting the health of the
communities in maybe less dramatic, but probably just as
important a way.
So I think our program, for example, declined the FluMist
vaccine because we had already made an extra outreach to the
high-risk populations, which we do consider our primary
responsibility, and we had no more staff time just to give the
lower-risk people the vaccine. We tried to let the private
doctors know it was available. We couldn't have done any more
than we did, having already doubled the staff commitment to
this program at a cost to others.
Chairman Tom Davis. OK. Thank you very much.
Mr. Waxman.
Mr. Waxman. Dr. Stroube, in your written testimony you
stated Virginia does not include the pneumococcal vaccine in
its childhood immunization program. Is this vaccine important
and is it recommended, and what are the implications of
Virginia not including this vaccine in its immunization
program?
Dr. Stroube. The Prevnar vaccine, which is pneumococcal for
children, has been recommended by the Federal authorities for
several years now, but it is an expensive vaccine and we have
been unable to afford to give it to all the children that need
it, and so that makes them at risk of pneumococcal diseases
such as pneumonia and ear infections.
Mr. Waxman. What are the lessons of this experience for the
new recommendation to provide flu vaccine to young infants?
Dr. Stroube. I think any time there is a recommendation to
expand or bring in a new vaccine, it has to come with money,
because there just isn't any money available. We are looking at
the vaccine purchase appropriations increasing by 50 percent
since 1999, but yet the cost of giving a child all the
recommended vaccines has increased by over 125 percent. So we
are falling behind, particularly every time we get a new
vaccine.
Mr. Waxman. Well, it is troubling to realize that the
President is proposing to make permanent tax cuts for the
richest Americans, but his budget can't fund the childhood
immunizations adequately.
Are you going to find yourself making progress under this
proposed budget or are you going to fall backward?
Dr. Stroube. Well, we will do the best we can under what we
have and prioritize what we do and try to use all the funding
we can both from the State and Federal Government to meet the
needs as we see them.
Mr. Waxman. I wonder if I can direct some questions to Dr.
Susan Allan, if you would.
Dr. Allan. Absolutely.
Mr. Waxman. The General Accounting Office is reporting
today that the smallpox vaccine program has diverted resources
from core public health activities. Do you agree this diversion
has been a concern at the local level? And if so, can you give
us any examples?
Dr. Allan. The smallpox vaccine program took a tremendous
amount of concentrated effort. I am actually speaking at a
conference next week on this, and the title of my presentation
is, ``Making Lemonade From A Box of Lemons.'' Dr. Stroube
already mentioned I am in the State of Virginia here, and we
have two staff with all of the Federal money, with the
commitments required at the State level for the labs and
technologies and other things. At the local level we had
enhancement by two staff in our health department. It took 22
people the equivalent of a week's time just over the first
couple months of the smallpox program, plus 3 of us essentially
full-time for 4 months just for the startup implementation of
this. So the cost in terms of redirecting our resources was
considerable.
Now, we tried. We are good public health people. We tried
to turn this into general principles of infection: education,
disease control, certainly enhancement with our relationship
with the doctors and hospitals. So there were some benefits to
this, but the cost to our system was a major disruption for a
full 6 months.
Mr. Waxman. That is interesting, because Secretary Thompson
assured us there would be adequate Federal funding for the
smallpox program, and what we are hearing is that this program
may have actually undermined some core public health
activities.
Dr. Allan. If I may add a point, the Federal money came to
the States with, in effect, a contract. It is a grant process,
so the States had pre-committed, as we did in our role with the
States, to what would be done with the money that came. So we
already had a full workload agenda that used all of the
resources provided, and then the smallpox program was dropped
on top of that. Compensation was provided after the fact, but
we don't run the local budget by going in the hole. So we
didn't create extra expenses for that, we cut other
commitments. So by the time, at least for many of us, that the
Federal money came, it was too late to do any good, whereas if
it had come with the commitment, there might have been some
value.
Mr. Waxman. Well, obviously this was, I would think, an
unintended consequence, and I am interested in your view. The
administration's budget is investing heavily in bio-
surveillance technologies. Are there any potential unintended
consequences to Federal efforts to detect bioterrorist agents
in the environment? And in the event of false positive results,
could these efforts generate more work and divert State and
local officials from core public health activities?
Dr. Allan. A number of our communities have already had
experience. A lot of the military establishments and some post
offices have had this. Here in the National Capital region, the
Anacostia Post Office had a false positive on an anthrax test
just a couple months ago, in November. Arlington had three post
offices that were shut down until we knew for sure that was not
a true positive, that it was in fact a bad test result.
Meanwhile, there were 10 of us who spent the equivalent of
almost a day and-a-half full time on this, and we put together
a treatment clinic for the postal workers because we didn't
know whether they had been exposed or not. We had 90 staff we
brought in on overtime and set up a clinic to treat them, for
one false positive. Rough estimate of the cost to us was about
$10,000 for that one false positive test. And these
technologies are untested and unproven; they generate a lot of
errors that, every time there is a hit on these systems, we are
going to have to drop whatever we are doing and investigate
them. So, you know, it is like having a smoke detector. If you
don't have a fire department to respond and see if it is a real
fire or not, what is the point of the smoke detector?
Mr. Waxman. Dr. Hearne, I understand Trust for America's
Health is a nonpartisan and nonprofit organization that focuses
on the need for a robust public health system in this country.
From your perspective, what, if anything, concerns you about
the President's fiscal year 2005 budget?
Dr. Hearne. Part of our concern has been just at a time
when we have had a series of wake-up calls--the flu outbreak
was just the beginning, we have had, since then, the avian flu,
certainly SARS before, anthrax and ricin last week. We are
getting bombarded with a number of very strong wake-up calls
that our public health system is a critical part of our
homeland security. But in fact what we have found in our
investigation is that it probably is the weakest link in
homeland security. What concerns us is there are a number of
gaps that we have identified and now is the last time that you
should be considering cuts to this budget, when in fact there
are very specific initiatives that need to be advanced,
particularly to protect us from all flanks. And so just the
fact the word ``cut'' is being used in the same sentence as CDC
is troubling.
Mr. Waxman. I understand you have a score card of State
preparedness, and the scorecard revealed that even as the
Federal Government was increasing resources for public health,
many States have cut their public health funding. How important
is it to track actual spending on public health by States and
localities? And as far as you know, is the CDC tracking actual
spending by States and localities? And is it troubling that
even at the same time the administration is proposing to cut
public health funding for States, it is failing to closely
track actual spending on necessary activities?
Dr. Hearne. Let me try to break that down in a few ways.
One, our report did find that approximately two-thirds of the
States were opening up the back door, they were removing funds
from their critical public health programs just at the time
when Federal funds were coming in, which risked diluting the
important investments that the Federal Government was making.
That is disturbing. The even more troubling point in this, as
you were raising concerns about accountability, we were not
able to get this information on State expenditures and
investments on the public health side from CDC. In fact, we
have received a number of calls from CDC to have our data
because they would like to know. It is important that they are
asking to know, but they should have known this for a long time
because certainly as one is looking to purchase better
protection and safety for the American citizens, you need to
know where your money is going; you need to know what you have
bought. And the fact that there has not been that
accountability measure, one, you can't track what is happening
in the States, you can't compare one State's activities to
another.
We actually had to contract with the National Conference of
State Legislators to get this data, which we are happy to
provide to CDC, but it should be a routine matter of tracking
and accountability. Just as we should be tracking diseases in
this country, we should also track where the money is going.
Mr. Waxman. Thank you.
Mr. Pien, from your perspective, what can the Federal
Government do to support the quickest possible development of
pandemic flu vaccine?
Mr. Pien. Mr. Waxman, as I testified before, I think that
one of the most important aspects of the private-public
partnership has been that of the advancement of technology and
sciences. In this regard, if we are going to be able to advance
the funding level with the National Institutes of Health, or at
least keep it at a level that can perpetuate these kinds of
partnerships, it would go a long way.
Second, I think that the considerations of how we
appropriate resources such that we can enhance the level of
natural growth in demand will go also a long way to the ability
for manufacturers in toto to be able to steadily increase their
investment and increase their capacity.
So the collaboration between the private sector in thinking
about how they can propagate the messages about the seriousness
of the disease that flu represents, along with the funding that
the CDC and all of the States and municipal and county agencies
that preside over infrastructure that will get the vaccines
into the arms of the people who need it, I think that will go a
long way to prepare the country's readiness for pandemic.
Mr. Waxman. I want to thank all the panelists for their
presentation.
Mr. Chairman, I wonder if we could keep the record open for
a short time to see if we can elicit further responses in
writing from some of the witnesses.
Chairman Tom Davis. Well, some offered to do that. We will
keep the record open for that. And in addition to that, we had
some witnesses who couldn't come who submitted written
testimony, and that will be put in the record.
I want to thank our witnesses today. It has been very
helpful to us. I want to thank you for your testimony.
I want to thank the committee staff that worked on this
hearing, and we are adjourned.
[Whereupon, at 12:31 p.m., the committee was adjourned, to
reconvene at the call of the Chair.]
[The prepared statement of Hon. Congressman Elijah E.
Cummings and additional information submitted for the record
follow:]
[GRAPHIC] [TIFF OMITTED] T3723.125
[GRAPHIC] [TIFF OMITTED] T3723.126
[GRAPHIC] [TIFF OMITTED] T3723.127
[GRAPHIC] [TIFF OMITTED] T3723.128
[GRAPHIC] [TIFF OMITTED] T3723.111
[GRAPHIC] [TIFF OMITTED] T3723.112
[GRAPHIC] [TIFF OMITTED] T3723.113
[GRAPHIC] [TIFF OMITTED] T3723.114
[GRAPHIC] [TIFF OMITTED] T3723.115
[GRAPHIC] [TIFF OMITTED] T3723.116
[GRAPHIC] [TIFF OMITTED] T3723.117
[GRAPHIC] [TIFF OMITTED] T3723.118
[GRAPHIC] [TIFF OMITTED] T3723.119
[GRAPHIC] [TIFF OMITTED] T3723.120
[GRAPHIC] [TIFF OMITTED] T3723.121
[GRAPHIC] [TIFF OMITTED] T3723.122
[GRAPHIC] [TIFF OMITTED] T3723.123
[GRAPHIC] [TIFF OMITTED] T3723.124
[GRAPHIC] [TIFF OMITTED] T3723.129
[GRAPHIC] [TIFF OMITTED] T3723.130
[GRAPHIC] [TIFF OMITTED] T3723.131
[GRAPHIC] [TIFF OMITTED] T3723.132
[GRAPHIC] [TIFF OMITTED] T3723.133