[Senate Hearing 109-740]
[From the U.S. Government Publishing Office]
S. Hrg. 109-740
PANDEMIC INFLUENZA PREPAREDNESS
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
JANUARY 31, 2006--WASHINGTON, DC
__________
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__________
COMMITTEE ON APPROPRIATIONS
THAD COCHRAN, Mississippi, Chairman
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico PATRICK J. LEAHY, Vermont
CHRISTOPHER S. BOND, Missouri TOM HARKIN, Iowa
MITCH McCONNELL, Kentucky BARBARA A. MIKULSKI, Maryland
CONRAD BURNS, Montana HARRY REID, Nevada
RICHARD C. SHELBY, Alabama HERB KOHL, Wisconsin
JUDD GREGG, New Hampshire PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas MARY L. LANDRIEU, Louisiana
WAYNE ALLARD, Colorado
J. Keith Kennedy, Staff Director
Terrence E. Sauvain, Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
MIKE DeWINE, Ohio MARY L. LANDRIEU, Louisiana
RICHARD C. SHELBY, Alabama RICHARD J. DURBIN, Illinois
ROBERT C. BYRD, West Virginia (Ex
officio)
Professional Staff
Bettilou Taylor
Jim Sourwine
Mark Laisch
Sudip Shrikant Parikh
Candice Ngo
Lisa Bernhardt
Ellen Murray (Minority)
Erik Fatemi (Minority)
Adrienne Hallett (Minority)
C O N T E N T S
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Page
Opening statement of Senator Arlen Specter....................... 1
Statement of Senator Tom Harkin.................................. 2
Statement of Dr. John Agwunobi, Assistant Secretary of Health,
Department of Health and Human Services........................ 4
Prepared statement........................................... 6
Statement of Dr. Julie L. Gerberding, Director, Centers for
Disease Control and Prevention, National Institutes of Health,
Department of Health and Human Services........................ 10
Prepared statement........................................... 12
Statement of John M. Barry, author, ``The Great Influenza''...... 28
Prepared statement........................................... 29
Statement of Dr. Richard Webby, professor, St. Jude Children's
Hospital....................................................... 32
Prepared statement........................................... 33
Statement of Dr. George B. Abercrombie, president, chief
executive officer, Hoffmann-La Roche Pharmaceuticals........... 34
Prepared statement........................................... 35
Statement of Daniel Soland, president of vaccines, Chiron
Corporation.................................................... 41
Prepared statement........................................... 42
Statement of Dr. Christopher Viehbacher, president of U.S.
Pharmaceuticals, GlaxoSmithKline............................... 45
Prepared statement........................................... 46
Statement of Dr. Mary Mincer Hansen, director, Iowa Department of
Public Health.................................................. 49
Prepared statement........................................... 50
Statement of Dr. Calvin B. Johnson, secretary, Pennsylvania
Department of Health........................................... 52
Prepared statement........................................... 53
Statement of Dr. Bruce W. Dixon, director, Allegheny County
Health Department.............................................. 64
Prepared statement........................................... 65
Statement of Dr. Joanne Godley, acting commissioner, Philadelphia
Department of Public Health.................................... 67
Prepared statement........................................... 68
Prepared statement of Senator Larry Craig........................ 77
PANDEMIC INFLUENZA PREPAREDNESS
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TUESDAY, JANUARY 31, 2006
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 8:30 a.m., in room SH-216, Hart
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Gregg, Stevens, Harkin.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies will now proceed with
this hearing on the issue of pandemic influenza preparedness at
the Federal, State and local levels. The subcommittee had an
initial hearing on this subject last November 2, the day
following the presentation by President Bush at the National
Institutes of Health, alerting the country to the potential of
a very, very serious health problem.
At that time, the President asked for an emergency
allocation of $7.1 billion, and the Congress responded with the
first years' funding of $3.3 billion. This hearing is designed
to acquaint the public with the scope of the potential problem.
It could be enormous, or it might not be a major problem.
That will depend upon what happens in many distant places
around the world, what happens in Asia, what happens in Turkey
and what happens by way of an influenza-contagious outburst. We
have already seen some 160 people infected by bird flu. We have
seen some 85 die. We have seen the problem move in a number of
directions from Asia to Turkey.
We are concerned about the problem of transmission from
birds to humans and then from humans to humans and the complex
question of mutation and the fact that we are not prepared at
this moment for what could occur. We are looking at issues of
vaccines where we are not prepared, and we'll get into the
details of that. We're looking at antiviral drugs, again, where
we are not prepared. The pandemics have a cyclical effect. In
1918, a pandemic--it is estimated it killed some 50 million
people around the world. We have had one as recently as 1968.
We have a very distinguished array of witnesses today. We
have the Assistant Secretary of Health of the Department of
Health and Human Services (HHS). We have the Director of the
Centers for Disease Control and Prevention (CDC). We have Mr.
John Barry, who wrote the book ``The Great Influenza'', who
testified before the committee last November 2.
Regrettably, the vote on Judge Alito for the Supreme Court
of the United States has been scheduled--well, it's not
regrettable that it's been scheduled. The timing is
troublesome. Speaking for myself, I practically lived in this
room with the Alito hearings for many, many days. We have had
an extended debate, which was curtailed yesterday afternoon.
That has placed the vote on the agenda for 11 o'clock, and it
is always a very difficult matter of scheduling. When it became
apparent that was happening, we moved the time up to 8:30 a.m.
So, when you came in this morning, the halls were all darkened,
and the Senate's not quite awake, but Senator Harkin and I are,
and so is a very large turnout for this very important hearing.
In yielding to Senator Harkin, I want to compliment him and
thank him for his especial alertness on this issue. His voice
was the first voice heard in the Congress of the United States
in the Senate chamber on the problem here. When Senator Harkin
speaks, everybody listens, but I listen first because we have a
very important partnership, crossing party lines on this
subcommittee, which has funding, I think, for the most
important aspects of life in America, health, without which
none of us is anything; education, which is the gold of the
future and worker safety. I yield at this time to my
distinguished colleague for his opening statement.
STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Mr. Chairman, thank you very much for those
kind statements. Again, it has been just a pleasure to work
with you for 16 years now on this important subcommittee of
Appropriations, dealing with all the things that you mentioned
about health and education, all the things that we've done to
move this country forward. Again, I want to thank you for your
leadership in providing the $8 billion that we put into the
bill. It was under your leadership that we were able to take
that lead and put that money in it. We didn't quite get it in
the end, but at least, I think, we've paved the way with your
leadership in putting that amount of money forward. I didn't
realize that when I spoke, you listened. Now, if I speak about
the Alito vote, will you listen about how I talk about how we
ought to vote on Alito, coming up at 11 o'clock? I don't know.
Senator Specter. Well, you can filibuster if you want,
Senator Harkin, but----
Senator Harkin. No, I'm talking about how to vote on it.
That's what I'm talking about.
Senator Specter. Do you want to call some more witnesses?
Senator Harkin. No, not at all. I've had it with that one.
Anyway, I just--again, thank you for having this hearing.
Again, I know we had that vote at 11 o'clock, and I'll try to
be brief, but, you know, we've had a couple of major disasters
in the United States in the last few years, and what we found
out is that we were just totally unprepared. We've been warned
about this avian flu influenza. We know what the dimensions of
it could be. This time, we've got to be prepared, and time is
running out. We know about H5N1. We know how it's been
transmitted. We know that it's widespread now.
Scientists, doctors, public health people tell us that it's
not a matter of if but when it will move into a pandemic stage.
We worked together last year, as I said, under the leadership
of Senator Specter to provide the funds for a possible
pandemic. We put $8 billion in our bill to be used first for
upgrading State and local capacity; second, stockpiling
vaccines and antivirals; third, increasing global surveillance
activities; and fourth, to expand the domestic production of
flu vaccine.
Unfortunately, in the end, Congress only provided a little
less than $4 billion for pandemic flu preparedness, about half
of what was in our bill, more than $3 billion less than
requested by the President. One of our witnesses today has said
in his written testimony, ``This shortfall did not send a
positive message to manufacturers about the certainty and
stability of the Government's efforts to fully address a public
health threat of this magnitude.''
On a more positive note, we are able to designate $350
million of the funds appropriated for upgrading State and local
response capacity to a pandemic, and I am going to be kind of
harping on that this morning. State and local public health
agencies will be on the front lines of both surveillance and
disease prevention should an outbreak occur.
So, Mr. Chairman, I'm glad to see that you've asked a
number of State and local public health directors to today's
hearings. In particular, I am pleased to see that Dr. Mary
Hansen, director of our Iowa Department of Pubic Health, will
be testifying before the subcommittee this morning. In fact,
this Friday, Secretary Leavitt will be in Des Moines having a
flu summit this Friday with the Governor, with me, with Dr.
Hansen. I just wanted to mention--I will ask some people to
comment on this. Speaking of State and local preparedness and
getting enough flu vaccine, it occurred to me that we have the
annual flu outbreak in the United States. We have a flu shot. I
always get my flu shots, but not very many of our population
do. They're pretty expensive, maybe $15 to $20 a shot. It
occurred to me that if we really want to build vaccine capacity
and other things, we ought to provide a free flu shot to
everyone in the United States. So, I introduced a bill. It's
now S. 2112--that would provide a free flu shot for every
person in America. It would do the following things, I believe:
Create demand for flu vaccines; second, stimulate the
production facilities; third, lower the cost of the flu shot
dramatically; four, it would stimulate public health agencies
to build sustainable delivery systems.
In case of a pandemic, we're going to have to get this
stuff out in a hurry, and we're going to have to have bigger
delivery systems than we have right now, sort of the what I
call the Wal-Martization of flu vaccines. Maybe we can give flu
vaccines and shots in Wal-Mart or at churches on Sunday and
places like that where there's a sustainable-type delivery
systems so that if a pandemic hits you, you can get out there
in a hurry; fifth, it would provide protection from the annual
flu. We know 36,000 people die every year, 200,000
hospitalizations, lost time, lost productivity. So, we provide
protection from the annual flu.
Last, there may be some major protection from the more
virulent strains. There's some evidence that maybe an annual
flu shot might provide some--build up some immunities that
would help protect people in case of a pandemic. So, I will ask
people to comment upon the possibility of having a free flu
shot, for everyone this morning, in America.
I'm also pleased to see Dr. Julie Gerberding this morning.
The Centers for Disease Control and Prevention is doing a great
job in cooperation with the World Health Organization and
governments in affected regions to detect the disease and help
to stop its spread, and I will have some questions for Dr.
Gerberding about that. Surveillance is the first line of
defense; to find it, isolate it so that widespread infection
does not occur.
So again, Mr. Chairman, thank you for calling this hearing.
It is timely. It's important. And under your leadership, we're
not going to let up on this. We're going to keep at this. We'll
keep at it until we can assure the American people that in case
of a pandemic, they are going to be protected. Thank you, Mr.
Chairman.
Senator Specter. Well, thank you very much, Senator Harkin.
We'll now turn to our first panel. Our first witness is Dr.
John Agwunobi, Assistant Secretary for Health in the U.S.
Department of Health and Human Services. He is an admiral in
the Public Health Commission Corps. He received his medical
degree from the University of Jos in Nigeria, holds an MBA from
Georgetown University and a master of public health from Johns
Hopkins University. Because we have to conclude this hearing
about 10:30 a.m., we are going to have to stick very close to
timelines and limit it very sharply to the testimony. If you're
an admiral, you get 5 minutes. It's all yours.
STATEMENT OF DR. JOHN AGWUNOBI, ASSISTANT SECRETARY OF
HEALTH, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Dr. Agwunobi. Thank you, sir. Thank you. Mr. Chairman and
Senator Harkin, thank you so much for this opportunity, this
invitation to testify on a topic which I know both President
Bush and Secretary Michael Leavitt have made top priorities. As
you know, Congress, and as you just stated, recently
appropriated $3.8 billion as the first installment on the
President's request. An amount of $3.3 billion was provided to
HHS to allow us to further our efforts to prepare for a
pandemic.
We appreciate the action and the expressed commitment of
Congress. It definitely allows us to take this first essential
step in our efforts to become the first generation in history
to be prepared for a possible pandemic. The majority of the HHS
appropriation will be spent in two major ways; first, the
production of countermeasures, both vaccines and antivirals and
other resources and supplies needed to respond; second, to
enhance planning and preparedness, training and exercising
across the Nation. Our vaccine strategy is to simultaneously
stockpile a limited amount of what we call pre-pandemic
vaccine. This is a vaccine that is developed today to the
prevailing H5N1 virus that's available and also build a
vaccine-manufacturing capacity that we can use to quickly ramp
up and produce what we call a pandemic vaccine. That would be a
vaccine that's used to protect against the pandemic virus once
it rears its ugly head.
Roughly $1.76 billion of the HHS allocation will be spent
on increasing vaccine production capacity. A portion of this
funding will go to accelerate cell-based manufacturing
technology. We will also fund projects to increase egg-based
capacity, including buying pre-pandemic vaccine from existing
egg-based manufacturers. We will develop strategies that allow
us to retrofit existing non-flu manufacturing facilities for
emergency production of influenza vaccine if it's ever called
upon.
We will support advance development contracts that could
extend the vaccine supply by decreasing the amount of vaccine
needed to protect each individual. This is a strategy that
would allow us to use adjuvants to extend the limited doses
that might be available.
Finally, we intend to develop a vaccine registry to monitor
vaccine safety, efficacy and distribution. Our antiviral drug
strategy involves the stockpiling of, currently, two drugs,
Tamiflu and Relenza. Currently, those two antiviral drugs
provide clinical benefits against all of the H5N1 strains
currently circulating in Asia, but it's important to note that
that may not necessarily be true over time as the virus
evolves.
HHS plans to acquire 20 million treatment courses in fiscal
year 2006 with a goal of acquiring 44 million treatment courses
by fiscal year 2008. This, obviously, will be subject to the
availability of funds. The plan provides for States to purchase
31 million treatment courses for which the Federal Government
would subsidize 25 percent of the costs. Let me restate that.
This would be a methodology by which the States could purchase,
at a subsidized price, antivirals on top of the distribution of
antivirals that they would receive from the Federal Government.
We also hope to fund advanced development in the development of
new antiviral drugs as we move forward.
HHS intends to allocate $350 million directly to the States
as per the instructions that we received from Congress. We want
them to use this to enhance their State and local preparedness.
This money will be divided into two pieces, with the first
piece totaling $100 million to be divided amongst the States on
a population basis.
We also intend to establish, and I'm sure my colleague will
talk about this, increased laboratory surge capacity, enhance
our strategic national stockpile with personal protective
equipment and a number of other efforts designed to improve
overall preparedness. The Secretary at the moment is working
his way around the Nation visiting each State in order to
participate in State summits, the goal being to try and drive
the notion of preparedness into local communities. He often
says a pandemic is a global phenomenon, but our response will,
by definition, be local.
It's essential that we focus our efforts on county, city,
community and State preparedness. Almost 30 of these summits
have either been completed or scheduled, and we look forward to
working with our State counterparts.
PREPARED STATEMENT
In conclusion, Mr. Chairman, although there has been much
accomplished, continued vigilance and preparation is definitely
needed. We do have a journey. Preparedness is a continuum.
There are many things that we will need to do into the future,
and we look forward to working hard to make them happen. Thank
you for this opportunity to share this information with you.
I'm happy to answer questions at the appropriate time.
Senator Specter. Thank you very much, Dr. Agwunobi.
[The statement follows:]
Prepared Statement of Dr. John Agwunobi
Mr. Chairman and members of the Subcommittee, I am honored to be
here today to describe for you how the Department of Health and Human
Services is working to improve preparedness for a potential human
influenza pandemic. Thank you for the invitation to testify on this
topic which Secretary Mike Leavitt has made a top priority. As you
know, the President requested $7.1 billion in emergency funding for the
National Strategy for Pandemic Influenza, of which $6.7 billion was
requested for HHS. Congress appropriated $3.8 billion as the first
installment of the President's request to begin these priority
activities, and of this amount, $3.3 billion was provided to HHS. We
appreciate the action of Congress on this appropriation as it takes us
an essential step forward to become the first generation in history to
be prepared for a possible pandemic.
As you are aware, the potential for a human influenza pandemic is a
current public health concern with an immense potential impact.
Pandemics are not new. There were three in the 20th century, the worst
of which was the Spanish flu epidemic in 1918-1919 that is estimated to
have killed over one half million people in the United States and 50
million worldwide. While we are focusing today on the impact of a
possible pandemic of avian flu, many of the policy issues and
preparedness measures that arise for avian flu apply as well to
pandemics of other types of influenza, other infectious disease
outbreaks and public health emergencies. To put the impact of a
pandemic in context, the seasonal influenza that we have today causes
an average of 36,000 deaths each year in the United States, mostly
among the elderly, and adds more than 200,000 hospitalizations.
Scientists cannot accurately predict the severity and impact of an
influenza pandemic, whether from the H5N1 virus currently circulating
in birds in Asia and Europe, or the emergence of another influenza
virus of pandemic potential. However, it is still useful to model
possible scenarios based on analysis of past pandemics. In a report
released in December 2005, the Congressional Budget Office presents the
results of modeling a severe pandemic scenario similar to the 1918
Spanish flu outbreak and a more moderate outbreak resembling the flu
pandemics of 1957 and 1968. In the severe scenario, roughly 90 million
people become ill and 2 million die in the United States and the impact
on the real Gross Domestic Product (GDP) is about a 5 percent reduction
in the year following the outbreak. In the ``mild'' pandemic scenario,
about 75 million people are infected in the United States and about
100,000 of them die. The impact on the GDP is approximately a 1.5
percent decline. While there is substantial uncertainty associated with
these estimates, they illustrate the enormous public health threat of
an influenza pandemic and the need for effective access to vaccines,
treatments, and a robust public health infrastructure to meet the
challenge.
There are several important points to note about an influenza
pandemic:
--A pandemic could occur anytime during the year and could last
longer than typical seasonal influenza, with possible repeated
waves of infection.
--The capacity to prevent or control transmission of the virus once
it gains the ability to be efficiently transmitted from person
to person will be limited.
--Right now, the H5N1 avian influenza strain that is circulating in
Asia and Europe among birds is considered the leading candidate
to cause the next pandemic. However, it is possible that
another influenza virus, which could originate anywhere in the
world, could cause the next pandemic. This uncertainty is one
of the reasons why we need to maintain year-round laboratory
surveillance of influenza viruses. As is the case with the
avian virus H5N1, pandemic influenza viruses often emerge in
animals. As they are transmitted among animals the viruses can
potentially mutate to a form that can be transmitted to humans.
Thus, it is critical to maintain constant surveillance of
viruses worldwide affecting animal populations and that can
potentially be transmitted to humans.
--We often look to history in an effort to understand the impact that
a new pandemic might have, and how to intervene most
effectively. However, there have been many changes since the
last pandemic in 1968, including changes in population and
social structures, medical and technological advances, and a
significant increase in international travel. Some of these
changes have increased our ability to plan for and respond to
pandemics, but other changes have made us more vulnerable.
THE CURRENT STATUS OF H5N1 VIRUS IN ASIA
Beginning in January 2004, the World Health Organization (WHO)
confirmed reports of new outbreaks of HPAI H5N1 infection among poultry
and waterfowl in several Asian countries. In 2005, outbreaks of H5N1
disease have also been reported among poultry in Russia, Ukraine,
Kazakhstan, Turkey, and Romania. Mongolia has reported outbreaks of the
H5N1 virus in wild, migratory birds. In October 2005, outbreaks of the
H5N1 virus were reported among migrating swans in Croatia. In 2004,
sporadic human cases of avian influenza A (H5N1) were reported in
Vietnam and Thailand. In 2005 additional human cases have been reported
in Cambodia, China, Indonesia, Thailand, Vietnam, and most recently
Turkey. Turkey first reported confirmed H5N1 cases on January 5, with 3
cases (2 fatal) in eastern Turkey. On January 9, Turkey reported 10 H5
cases, and an additional 2 cases from Agri province on January 16. To
date, Turkey has reported a total of 21 H5N1 human cases, 4 of them
fatal, confirmed by a national laboratory in Ankara. Four cases (2
fatal) have been verified by a WHO lab in the United Kingdom. Of the 21
cases, 19 have been children aged 4-18 years. All cases seen in Turkey
so far developed illness following direct exposure to diseased poultry.
Cumulatively, as of January 30, 2006, 160 human cases have been
reported and laboratory confirmed by WHO. These cases have resulted in
85 deaths, a fatality rate of approximately 53 percent among reported
cases. Almost all cases of H5N1 human infection appear to have resulted
from some form of direct or close contact with infected poultry,
primarily chickens. In addition, a few persons may have been infected
through very close contact with another infected person, but this type
of transmission has not led to sustained transmission.
For an influenza virus to cause a pandemic, it must: (1) be a virus
to which there is little or no pre-existing immunity in the human
population; (2) be able to cause illness in humans; and, (3) have the
ability for sustained transmission from person to person. So far, the
HPAI H5N1 virus circulating in Asia and Europe meets the first two
criteria but has not yet shown the capability for sustained
transmission from person to person.
The highly pathogenic avian influenza A (H5N1) epizootic (or
animal) outbreak in Asia that is now beginning to spread into Europe is
not expected to diminish significantly in the short term. It is likely
that H5N1 infection among birds has become endemic in certain countries
in Asia and that human infections resulting from direct contact with
infected poultry will continue to occur. So far, scientists have found
no evidence to indicate that the virus has changed to make it easier to
transmit from person to person. However, the animal outbreak continues
to pose an important public health threat, because there is little
preexisting natural immunity to H5N1 infection in the human population.
It is quite certain that a threat anywhere in the world is a threat
everywhere.
WORKING TO MEET THE EXISTING THREAT
On November 1, 2005, President Bush released the National Strategy
for Pandemic Influenza, which outlines the roles of the Federal
Government, State and local governments, private and international
partners, and individual citizens in preparing for and responding to an
influenza pandemic. The following day, Secretary Leavitt announced the
HHS Pandemic Influenza Plan--a blueprint for all HHS pandemic influenza
preparedness and response planning. The HHS Plan provides guidance to
national, State, and local policy makers and health departments with
the goal of achieving national readiness and the ability to respond
quickly and effectively to a pandemic. The HHS plan also includes an
outline of key roles and responsibilities during a pandemic. In the
event of a pandemic and the activation of the National Response Plan,
HHS has a critical lead role to manage the public health and medical
response and support the Department of Homeland Security in their role
of overall domestic incident management and Federal coordination.
On November 1, 2005, the President requested an additional $7.1
billion in emergency appropriations for fiscal year 2006, including
appropriations for HHS totaling $6.7 billion to support implementation
of the National Strategy for Pandemic Influenza.
In seeking this funding, the goals were to:
(1) Produce a course of pandemic influenza vaccine for every
American within 6 months of an outbreak;
(2) Provide enough antiviral drugs and other medical supplies to
treat over 25 percent of the U.S. population; and
(3) Ensure a domestic and international public health capacity to
detect and respond to a potential pandemic influenza outbreak.
On December 30, 2005, President Bush signed into law the Department
of Defense Appropriations Act of 2006 (Public Law No: 109-148)
providing approximately $3.8 billion for pandemic influenza
preparedness activities for fiscal year 2006, of which $3.3 billion was
appropriated to HHS. The majority of the HHS appropriation will be
spent in two major areas: the production of countermeasures (vaccines
and antiviral drugs) and enhanced domestic preparedness. I would like
to talk in depth about these areas, as well as describe other ongoing
activities.
VACCINES
The optimal way to control the spread of a pandemic and reduce its
associated morbidity and mortality is through the use of vaccines.
Broadly speaking, vaccines may be divided into those that are developed
against strains of animal influenza viruses that have caused isolated
infections in human, which may be regarded as ``pre-pandemic''
vaccines, and those that are developed against strains that have
evolved the capacity for sustained and efficient human-to-human
transmission (``pandemic'' vaccines). Because emergence in human
populations necessarily reflects genetic changes within the pandemic
virus, pre-pandemic vaccines may be a good or poor match for--and offer
greater or lesser protection against--the pandemic strain that
ultimately emerges. Thus, our strategy is to simultaneously stockpile a
limited amount of pre-pandemic vaccine and also build vaccine
manufacturing capacity so that we can quickly produce pandemic vaccine
when and if a pandemic occurs.
Roughly $1.76 billion of the HHS allocation will be spent on
increasing vaccine production capacity. A portion of this funding will
go to accelerate cell-based manufacturing technology. Because the surge
capacity needed for a pandemic cannot be met by egg-based production
alone, cell-based technology, which is insensitive to seasons and can
be adjusted to vaccine demand, is a critical supplement to our Nation's
surge capacity.
At the same time, HHS believes that it is vital that investments
continue to be made to increase egg-based vaccine production capacity,
given the years of experience and proven success with this technology.
Therefore, HHS will fund projects to increase egg-based capacity,
including buying pre-pandemic vaccine from existing egg-based
manufacturers. In addition, HHS will retrofit existing non-flu
manufacturing facilities for emergency production of influenza vaccine.
In addition, HHS will support advanced development contracts for
antigen sparing techniques. Antigen-sparing strategies, if successful,
could extend the vaccine supply by decreasing the amount of vaccine
needed to protect each individual. Finally, HHS intends to develop a
vaccine registry to monitor vaccine use (safety/efficacy) and
distribution.
ANTIVIRAL DRUGS
In the event of a pandemic, antiviral drugs will be the first line
of defense before a vaccine is available and could delay the spread of
the pandemic, particularly if the strain is not efficiently transmitted
between humans. Their effectiveness will be limited to the accuracy of
detecting pandemic influenza and whether the pandemic strain is
sensitive to current antiviral drugs.
HHS funding will also be allocated to acquire antiviral drugs.
Currently two drugs, Oseltamivir (Tamiflu) and Zanamivir (Relenza)
provide clinical benefit against all of the H5N1 virus strains
currently circulating in Asia. HHS intends to complete the ``20/20
plan'' of achieving 20 million courses in fiscal year 2006, with the
goal of achieving 44 million courses by fiscal year 2008, subject to
the availability of funds. HHS also intends to purchase 6 million
courses of antiviral for purposes of containment, if feasible, in the
event of 1-2 isolated, domestic outbreaks. The plan calls for States to
purchase the remaining 31 million treatment courses, for which the
Federal Government would subsidize 25 percent of the cost. Finally, HHS
intends to fund the advanced development work on promising new
antiviral drugs.
DOMESTIC PREPAREDNESS
HHS will allocate $350 million directly to States to enhance their
State and local preparedness. This money will be divided into two
pieces, with the first piece totaling $100 million to be divided
amongst the States on a population basis. Secretary Leavitt announced
this $100 million in funding for State and local preparedness on
January 12. CDC is currently finalizing a self assessment tool for
States to evaluate their readiness. This self-assessment tool will be
sent to States, and as soon as the assessment is completed and sent
back to CDC, each State will receive its portion of these funds. The
second piece, the remaining $250 million, will be used to enhance State
preparedness and will be allocated in the near future contingent on
each State meeting specific preparedness goals, timelines, and targets
as agreed to by HHS, CDC, and the State. These stipulations will be
contained in an Agreement that each State governor will sign with
Secretary Leavitt at the ongoing State summits.
Other fiscal year 2006 funds will be used to enhance the Strategic
National Stockpile by increasing the quantities of personal protective
equipment (PPE), ventilators, and other medical supplies needed in a
pandemic outbreak. Approximately $50 million will be spent on
establishing and increasing laboratory surge capacity. Funding has also
been designated for the advanced development of rapid detection tests
for human avian influenza. With regard to domestic surveillance, HHS
plans to accelerate CDC's BioSense real-time surveillance system to
enhance our ability to detect an outbreak early.
HHS will also direct funding to enhance international surveillance,
expanding clinical trials in Southeast Asia, and implementing rapid
outbreak response in currently affected countries. HHS plans to
allocate funds for risk communications strategies and overall pandemic
preparedness and planning within the Office of the Secretary.
STATE AND LOCAL PREPAREDNESS
In addition, at the direction of President Bush, Secretary Leavitt
convened senior State and local officials from across the country on
December 5, 2005 to establish an integrated Federal-State influenza-
pandemic planning process. The White House Homeland Security Council,
the U.S. Department of Homeland Security, and the U.S. Department of
Agriculture also participated in the meeting. Secretary Leavitt asked
participants to begin preparing for a series of in-state pandemic-
planning summits to be held in each State over the next several months.
The summits are intended to inform and involve public health, emergency
response, political, economic and community leadership in the planning
process.
Secretary Leavitt has since embarked on a Nation-wide tour to
support State and local pandemic preparedness and planning efforts. His
tour has the ambitious goal of visiting 50 States and 10 U.S.
territories within 120 days. Thus far, the Secretary has completed
summits in Minnesota, Arizona, Rhode Island, Vermont, Georgia, West
Virginia, and Kentucky. These summits have been attended by hundreds of
people at each venue and have brought together physicians, hospital
executives, transportation workers, business owners, town officials,
police officers, rescue squad volunteers, members of the agriculture
sector and many other community leaders. In some States, the summit was
broadcast to audiences in remote locations across the State as well.
The central goal of the Secretary's visits is to raise awareness of
pandemic preparedness in sectors which may have not been previously
briefed on the current pandemic threat. The Secretary feels that it is
essential that schools, universities, businesses, faith-based
organizations, and various other community groups and organizations
realize the impact that a pandemic may have on them.
In this regard, to assist in State and local preparedness, the
Centers for Disease Control and Prevention has released a series of
checklists to aid States in their preparation for a pandemic in a
coordinated and consistent manner across all segments of society. At
this time, a State and local government checklist, a business
checklist, an individual & families checklist, and a checklist for
community organizations have been released. The state and local
government checklist, of note, is specifically aligned with the CDC
Preparedness Goals and the HHS Pandemic Influenza Plan, Public Health
Guidance for State and Local Partners. It delineates action items over
a comprehensive range of issues, including community preparedness
leadership and networking, surveillance, public health and clinical
laboratories, healthcare and public health partners, infection control
and clinical guidelines, vaccine distribution and use, antiviral drug
distribution and use, community disease control and prevention, public
health communications, and workforce support. In addition, there are a
number of checklists pertaining to the education and healthcare
communities that are in the clearance process and scheduled to be
released in the coming weeks. CDC has also prepared a Pandemic
Influenza Toolkit for health care providers which provides a
compilation of resources and information to clinicians for their use in
discussing pandemic influenza with patients and providing care in case
of a flu pandemic in the United States. Finally, www.pandemicflu.gov,
the U.S. Government's official Web site for information on pandemic flu
and avian influenza, contains updated information on international
developments, the status of State summits, and on activities that can
be initiated by various sectors of government and community to prepare
now for a pandemic.
Finally, at each State summit, the Secretary and the Governor will
be signing an Agreement laying the foundation for the financial
assistance to be provided to States and also clearly delineating areas
for mutual cooperation between the Federal Government and States as we
jointly prepare for a potential future pandemic. For example, HHS will
be providing substantial technical assistance to States in the areas of
pandemic planning and logistical support and assistance to State and
local health departments, health care agencies, and hospitals. The CDC
will be particularly involved in support for epidemiological and
diagnostic services, and distribution and storage of vaccines and
antiviral drugs.
CONCLUSION
I hope my testimony today has provided you a summary of the current
threat of pandemic influenza, the plans for which the Department of
Health & Human Services intend to spend appropriated money to enhance
domestic and international readiness, and the on-going activities and
relationships being forged with States to enhance their overall
preparedness for a potential pandemic. Although much has been
accomplished, continued vigilance and preparation are needed for us to
be ready for a pandemic.
Thank you for the opportunity to share this information with you. I
am happy to answer any questions.
Senator Specter. We'll now turn to the distinguished
Director of the Centers for Disease Control and Prevention, Dr.
Julie Gerberding. She also serves as associate clinical
professor of medicine at Emory, a bachelors' and doctorate MD
from Case Western Reserve, a master's in public health from the
University of California at Berkeley. Dr. Gerberding has
testified before this subcommittee on many occasions and before
many, many other committees of Congress and has been very, very
responsive to our requests, and she's held in very high esteem.
So, thank you for coming in today, Dr. Gerberding, and we look
forward to your testimony.
STATEMENT OF DR. JULIE L. GERBERDING, DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION,
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Dr. Gerberding. Thank you, sir. I have three points I'd
like to make. The first is a thank you to the leaders of the
committee as well as the committee members for your incredible
support of this particular flu agenda and for all of our health
protection activities. It matters. My second point will be to
update you on the status of influenza. My third will be to
summarize some of the things we're doing at the State and local
level about it at this point in time. Our situation report in
terms of avian influenza is serious. We have ongoing and
spreading prevalence of H5N1 in migratory birds. We have
continued outbreaks among domestic poultry in an increasing
number of countries. We know the virus can infect animals,
including cats and pigs. We had infected tigers at the Thai Zoo
who were fed chickens, for example. We know pigs have been
infected. We know the virus is evolving. Last year's virus
strains collected in Vietnam are genetically distinct from the
virus strains that are spreading this year. We've had more than
150 case reports confirmed by WHO to date and more that are in
progress with the case fatality rate currently at 53 percent.
We have seen rare person-to-person transmission of the
virus in at least two cases. We have basically everything of
concern except for the last requirement for a pandemic, and
that is we have not seen sustained and rapid person to person
transmission. We hope we never check this last box, but we are
certainly as close to checking it as we've been in the last
several decades, and that is why we are focusing particularly
on H5N1.
We have a couple of major concerns about this virus. One is
that it is everywhere and that it is in common contact with
people. These photographs show the mixing of the migratory
birds, which are carrying it, and people literally sleeping in
their chicken coop where they are at risk for inhaling the
virus and acquiring it. This is one of the reasons why as the
weather gets cold, people bring their chickens indoors. They
sleep with them, and we're seeing an up tick in cases in places
like Turkey.
But this virus is also especially bad. We know from
research done at CDC and at the Department of Defense that the
H5N1 virus is similar to the 1918 virus, which also emerged
from birds. This chest x-ray illustrates how rapidly a person
can go into total lung failure just over a couple of days
because the virus is so aggressive and so invasive and causes
very severe disease and requirements for intensive care and
intubation. CDC along with our partners under Secretary
Leavitt's leadership are doing many things including
surveillance, laboratory support, development of international
response capability in the priority countries, but we're also
doing research on the front line.
The graphic at the top here, it shows one of the CDC
scientists in Asia working, literally, on laboratory research
in the field next to chickens and people who are exposed to
those chickens. We are studying how we can best slow down and
delay transfer of this virus in the context of the community.
We're studying best ways to deliver vaccine, what systems are
necessary, what kinds of things at the community level can
prevent transmission. Certainly, we're studying how best to use
the countermeasures like vaccines and antivirals that could
save lives in the context of a pandemic.
Our planning protocol is going very deep. We believe that
we are only as prepared as our weakest link, and we have
developed a number of checklists for a whole variety of people
outside the health community so that our businesses are
prepared, our schools are prepared, our churches are prepared,
our health system is prepared, our travelers are prepared. And
these checklists apply even to people in their homes. We have a
checklist for families and individual citizens so that people
understand where they are on their preparedness and what they
need to do to protect themselves and their families.
We hope we don't have an influenza pandemic, but if we
don't, these preparations will still pay off because they will
benefit us for seasonal flu. We will save lives during seasonal
flu because of these investments. We'll have a better vaccine.
We'll have more and better drugs. We'll have community health
systems that are protecting against other threats.
I think most importantly, for the many people who couldn't
get their flu shot this year or who suffered from influenza,
we'll have peace of mind that we, as a Government and as a
citizen, we have done everything that we can to protect people
against influenza.
PREPARED STATEMENT
Complacency is our worst enemy, and we appreciate you for
making sure that that enemy is not at our doorsteps on this
issue.
[The statement follows:]
Prepared Statement of Dr. Julie L. Gerberding
Mr. Chairman and members of the Subcommittee, I am pleased to be
here today to describe the current status of avian influenza around the
world; CDC's role in the Department of Health and Human Services (HHS)
Pandemic Influenza Plan; and CDC's pandemic influenza preparedness
activities. We appreciate the support of the Members of this
Subcommittee provided so that funding was included in the fiscal year
2006 Department of Defense (DOD) Appropriations Bill for HHS and CDC. A
pandemic flu outbreak would have profound impacts on almost every
sector of our society. Such an outbreak would require a coordinated
response at all levels of government--Federal, State, and local--as
well as the participation of the private sector and each of us as
individuals. HHS and CDC have been leaders in this effort.
I am pleased to be here today with HHS Assistant Secretary for
Health Dr. John Agwunobi who has articulated the pandemic preparedness
planning underway. Both history and science clearly tell us that
influenza pandemics are inevitable. The next pandemic could emerge from
the current H5N1 strain affecting Asia and Europe, or it could emerge
from another influenza strain. One of CDC's roles in protecting the
Nation's health is to provide ongoing surveillance information for the
United States on influenza strains circulating throughout the world.
THE CURRENT STATUS OF H5N1 VIRUS IN ASIA AND EUROPE
Beginning in January 2004, the World Health Organization (WHO)
confirmed reports of new outbreaks of highly pathogenic avian influenza
(APAI) A H5N1 infection among poultry and waterfowl in several East
Asian countries. In 2005, outbreaks of H5N1 disease also were reported
among poultry in Russia, Ukraine, Kazakhstan, Turkey, and Romania, in
Mongolia among wild, migratory birds, and in migrating swans in
Croatia.
In 2004, sporadic human cases of avian influenza A (H5N1) were
reported in Vietnam and Thailand. In 2005 additional human cases were
reported in Cambodia, China, Indonesia, Thailand, and Vietnam. Turkey
began reporting human cases in early January 2006. Cumulatively, as of
January 30, 2006, 160 human cases have been reported from a total of 6
countries and laboratory confirmed by WHO. These cases have resulted in
85 deaths, a fatality rate of 53 percent among reported cases. Almost
all cases of H5N1 human infection appear to have resulted from some
form of direct or close contact with infected poultry, primarily
chickens. In addition, a few persons may have been infected through
very close contact with another infected person, but this type of
transmission has not led to sustained transmission.
CDC'S PANDEMIC INFLUENZA PLANNING PREPAREDNESS ACTIVITIES
On November 1, 2005, President Bush released The National Strategy
for Pandemic Influenza, which outlines the roles of the Federal
government, State and local governments, private and international
partners, and individual citizens to prepare for and respond to an
influenza pandemic. The following day, Secretary Leavitt introduced the
HHS Pandemic Influenza Plan--a blueprint for all HHS pandemic influenza
preparedness and response planning. Under the rubric of the HHS
Pandemic Influenza Plan, CDC is developing a fully executable
operations plan that will provide specific policies and procedures for
each key area of CDC's involvement in the overall national response to
a potential influenza pandemic. The development of the plan includes
input from State and local partners through both formal and informal
mechanisms. We anticipate completion of the operations plan by the
spring of 2006, after which agency practice simulation exercises will
begin.
CDC has encouraged States to use its preparedness framework as the
foundation for their pandemic influenza plans. State plans were
submitted to CDC as part of their 2005 Public Health Emergency
Preparedness Cooperative Agreements. Key elements of these plans
include the use of surveillance, infection control, antiviral
medications, community containment measures, vaccination procedures,
and risk communications. To promote pandemic influenza planning and
awareness at the State and local level, the Secretary is holding
summits in all 50 States. These in-state summits will help the public
health and emergency response community inform and involve their
political, economic, agricultural and community leaders in this
process. To date, summits have taken place in West Virginia, Vermont,
Kentucky, Georgia, Rhode Island, Arizona, and Minnesota.
Congress recently included $350 million in the emergency
appropriations to support efforts to upgrade State and local capacity
to respond to pandemic influenza. On January 12, 2006, Secretary
Leavitt announced plans for the release of the first $100 million of
the funding. The remaining $250 million will be made available later
this year when States and local governments have established benchmarks
and met the performance objectives and timelines put forth in the
guidance. These stipulations will be contained in an Agreement that
each State Governor will sign with Secretary Leavitt at the summits.
PREVENTION
CDC's prevention activities intend to increase the use and
development of interventions known to prevent influenza. CDC's roles in
the research, development and manufacturing of vaccines and public
health prevention activities as identified under the HHS Pandemic
Influenza Plan encompass CDC's efforts towards our prevention goal.
Development and Manufacture of Vaccine
During an influenza pandemic, the existence of influenza vaccine
manufacturing facilities functioning at full capacity in the United
States will be critically important. The U.S. vaccine supply at present
is particularly fragile; only one of four influenza vaccine
manufacturers that sell in the U.S. market makes its vaccine entirely
in the United States. In fiscal year 2006, appropriated resources to
support pandemic preparedness will be used to encourage greater
production capacity by enhancing the U.S.-based vaccine manufacturing
surge capacity and developing antigen sparing technologies. This will
help the United States prepare for a pandemic and further guard against
annual shortages.
One of the main efforts by HHS in pandemic preparedness is to
expand the Nation's use of influenza vaccine during inter-pandemic
influenza seasons. In fiscal year 2006, $40 million was appropriated
through the Vaccine For Children (VFC) program to purchase influenza
vaccine for the national pediatric stockpile as additional protection
against annual outbreaks of influenza. Increased annual production
efforts should strengthen our capacity for vaccine production during a
pandemic. We are also developing strategies to increase influenza
vaccine demand and access by persons in high-risk groups that are
currently recommended to receive vaccine each year.
DETECTION AND REPORTING
CDC's efforts are directed towards decreasing the time needed to
classify an influenza outbreak, decreasing the time needed to detect
and report an influenza outbreak with pandemic potential, and improving
the timeliness and accuracy of communications regarding the threat
posed by an influenza outbreak with pandemic potential. CDC focuses on
detection and reporting by strengthening our national local
laboratories, enhancing laboratory capacity and research, supporting
our BioSense surveillance system and other real-time surveillance,
studying human-animal interfaces to learn more about the zoonotic
nature of pandemic influenza, and strengthening CDC's quarantine
stations.
State Laboratory Preparedness
CDC is working to strengthen national local laboratory capacity by:
(1) ensuring that States have sufficient epidemiologic and laboratory
capacity both to identify novel viruses throughout the year and to
sustain surveillance during a pandemic; (2) improving reporting systems
so that information needed to make public health decisions is available
quickly; (3) enhancing systems for identifying and reporting severe
cases of influenza; (4) developing population-based surveillance among
adults hospitalized with influenza; and, (5) enhancing monitoring of
resistance to current antiviral drugs to guide policy for use of scarce
antiviral drugs.
Collaboration with the Council for State and Territorial
Epidemiologists (CSTE) has considerably improved domestic surveillance
through making pediatric deaths associated with laboratory-confirmed
influenza nationally notifiable, and by implementing hospital-based
surveillance for influenza in children at selected sites. CDC will
continue to work with CSTE to make all laboratory-confirmed influenza
hospitalizations notifiable. Since 2003, interim guidelines have been
issued to States and hospitals for enhanced surveillance to identify
possible H5N1 infections among travelers from affected countries, and
these enhancements continue. Special laboratory training courses to
teach State laboratory staff how to use molecular techniques to detect
avian influenza have been held.
Enhanced Laboratory Capacity and Research
In fiscal year 2006, emergency supplemental resources will support
laboratory capacity and research at CDC. Close collaboration with many
partners will be vital to enhancing laboratory capacity and research at
CDC. The following are among the steps our agency is taking:
--Applying advanced mass spectrometry techniques and analysis to
examine structural changes in viral surface proteins that will
help identify factors that alter the virulence of influenza
viruses and to better characterize drifts and shifts in the
influenza viruses.
--Enhancing pandemic influenza research in collaboration with the
Laboratory Response Network (LRN). This includes determining
the potential for increasing stocks of diagnostic reagents for
influenza and accelerating research and development for
diagnostic tests.
--Maintaining a library of pandemic influenza reference strains.
--Enhancing laboratory capacity to increase throughput and working
with international partners to address critical issues that may
affect the timely sharing of data.
BioSense and Real-time Surveillance
CDC's BioSense program improves the Nation's capabilities for
monitoring community health by providing rapid access to timely data
from hospitals and healthcare systems in several major metropolitan
cities. It provides the immediate, continuous and comparable
information needed to inform local, State, and national public health
in participating areas, and to support national preparedness by using a
network that includes hospital systems, Department of Veterans Affairs
and Department of Defense facilities, poison control call centers, and
the largest clinical laboratory in the United States. In responding to
the threat of pandemic influenza with the support of additional funding
in fiscal year 2006, CDC plans to further accelerate implementation of
the BioSense program in 2006 by increasing the number of participating
cities, the number of healthcare systems and real-time clinical data
sources within those cites, and incorporating other existing health
data sources of importance in monitoring influenza activity and the
effectiveness of emergency response.
Human-animal Interface Studies
CDC will receive funds in fiscal year 2006 to support human-animal
interface studies that will improve understanding of avian and other
zoonotic-related influenza strains. CDC strategies in this area focus
on studies of poultry and other domestic animals and on the potential
impact of migratory wild birds. CDC will coordinate with partners to
conduct epidemiological studies in countries that have documented H5N1
infection in poultry, especially those that also have confirmed human
H5N1 cases. In addition, CDC works with its partners to coordinate
surveillance between the human and animal health sectors in response to
emerging zoonotic diseases of public health importance including avian
influenza. In addition, CDC has established close working relationships
with organizations such as the Wildlife Conversation Society, the
American Zoological Association, and the International Species
Information System to ensure that surveillance data about migratory
bird and captive bird species can be shared in a timely and transparent
manner to promote early detection of avian influenza.
Enhancement of Quarantine Stations
Under its delegated authorities, CDC is responsible for preventing
the introduction, transmission, and spread of communicable diseases
from foreign countries into the United States. This effort includes
maintaining quarantine stations. Currently, CDC's Quarantine Stations
are actively involved in pandemic influenza preparedness at their
respective ports of entry. We have expanded the Nation's Quarantine
Stations; currently, CDC has a presence at 18 Quarantine Stations, and
is working to fully staff these stations. HHS and the Department of
Homeland Security (DHS) have recently established a Memorandum of
Understanding setting out specific cooperation mechanisms to combat the
introduction and spread of communicable diseases. These include DHS
assistance with passive and, in certain instances, active surveillance
of passengers arriving from overseas, as well as information sharing to
assist in contact tracing of passengers with communicable or
quarantinable diseases. HHS/CDC will provide training and other
necessary support to reduce the potential of disease to enter the
United States.
Informing the Public
Risk communication planning is critical to pandemic influenza
preparedness and response, and funds are budgeted in fiscal year 2006
in the Office of the Secretary to support communication preparation in
the case of a pandemic. HHS and CDC are committed to the scientifically
validated tenets of outbreak risk communication. It is vital that
comprehensive information is shared across diverse audiences,
information is tailored according to need, and information is
consistent, frank, transparent, and timely.
In the event of an influenza pandemic, clinicians are likely to
detect the first cases; therefore messaging prior to a pandemic
includes clinician education and discussions of risk factors linked to
the likely sources of the outbreak, in addition to information targeted
for specific groups, such as businesses and State and local officials.
Given the likely surge in demand for healthcare, public communications
must include instruction in assessing true emergencies, in providing
essential home care for routine cases, and basic infection control
advice. This comprehensive risk-communication strategy can inform the
Nation about the medical, social, and economic implications of an
influenza pandemic, including collaborations with the international
community.
INVESTIGATION AND CONTROL
CDC's investigation efforts focus on decreasing the time needed to
identify causes, risk factors, and appropriate interventions for those
affected by the threat of pandemic influenza and to decrease the time
needed to provide countermeasures and health guidance to those affected
by the threat of pandemic influenza. These efforts include activities
that support rapid outbreak response and purchasing and stockpiling
antiviral medications.
Rapid Outbreak Response
Rapid response to international outbreaks has been a part of CDC's
mandate for decades, but recently published work suggesting challenges
involved in slowing or containing an influenza pandemic makes the
importance of such response more clear. For optimal response, a nascent
influenza pandemic outbreak anywhere in the world must be recognized
within 1 to 2 weeks and investigated and virologically confirmed within
days. An unprecedented and well-coordinated response must be launched
in stages in response to pre-planned trigger points, including
deployment of dozens to hundreds of trained teams, public health
messages, social isolation measures, movement restriction, treatment of
patients, and tracing and prophylaxis of contacts.
In response to this challenge, CDC has developed a comprehensive
Global Disease Detection (GDD) strategy. In fiscal year 2006, funding
is included to expand international surveillance, diagnosis, and
epidemic investigation efforts. Additional funding in fiscal year 2006
will build rapid outbreak response capability in 15 avian influenza
affected countries. The strategy is integrated with WHO and other
international partners. Regional workshops and other efforts have
already begun that build local infrastructure for epidemiologic and
laboratory disease detection, develop rapid outbreak and response
teams, and establish and maintain appropriate stockpiles. The
Investigation and Control goals during the next 3 to 9 months are
focused on detection and rapid outbreak response to an avian influenza
A (H5N1) outbreaks in Southeast Asia, Eastern Europe, and other
affected areas. In the longer term, our rapid outbreak response will be
focused on virtually any infectious disease threat anywhere in the
world.
Antiviral Drugs
Acquiring, distributing, and using antiviral drugs is an essential
preparedness activity for both seasonal and pandemic influenza.
Congress provided funding of $525 million in fiscal year 2006 to
purchase and maintain the materials for the Strategic National
Stockpile (SNS), including antivirals. Recent studies at CDC have shown
that 91 percent of currently circulating human strains of seasonal
influenza in the United States and H5N1 isolates from people in Asia
during the past 2 years indicate that these viruses are resistant to
the cheaper and more available class of antiviral medications, the
adamantanes, but are sensitive to the neuramidase inhibitor class of
drugs such as oseltamivir (Tamiflu) and zanamivir (Relenza). Ongoing
surveillance and monitoring of the status of antiviral sensitivity is
absolutely critical as CDC continues its work to procure additional
influenza countermeasures for the SNS. Information on antiviral
sensitivity is important for developing the most up-to-date public
health policy for effective use of antiviral medications.
RECOVERY
The U.S. healthcare system will be severely stressed by an
influenza pandemic. In addition to critical preparation needed to
respond successfully to the acute medical care needs of the population,
the healthcare system will also need to resume normal services as
rapidly as possible. CDC's work to improve the national healthcare
system's capacity to respond is also included under this goal.
Healthcare System
Healthcare facilities need to be prepared for the potential rapid
pace and dynamic characteristics of a pandemic. Medical surge capacity
is limited, and could be vastly outpaced by demand. However, all
facilities should be equipped and ready to safely provide care for a
limited number of patients infected with a pandemic influenza virus
early in a pandemic. Thereafter, recovery of necessary staffing and
supply lines will be essential in order to provide for the large number
of patients that would require care in the setting of escalating
transmission. Preparedness activities of healthcare facilities need to
be synergistic with those of other pandemic influenza planning efforts.
CDC has developed, with input from State and local health
departments and healthcare partners, including other Federal agencies,
guidance that provides healthcare facilities with recommendations for
developing plans to respond to an influenza pandemic and guidance on
the use of appropriate infection control measures to prevent
transmission during patient care. Development of and participation in
tabletop exercises over the past 2 years have identified gaps and
provided recommendations for healthcare facilities to improve their
readiness to respond and recover after a pandemic, as an integrated
part of the overall planning and response efforts of their local and
State health departments. The healthcare system has made great strides
in preparation for a possible pandemic, but additional planning still
needs to occur.
IMPROVEMENT
The investment required in preparing for an influenza pandemic is
resource and time intensive. Iterative consideration and evaluation of
activities funded by the U.S. Government are necessary to assure the
development of best practices approaches to pandemic preparation.
CONCLUSION
Although much has been accomplished, from a public health
standpoint, more preparation is needed to prepare for the public health
response to a possible human influenza pandemic. As the President
mentioned during the announcement of his National Strategy for Pandemic
Influenza, our first line of defense is early detection. Although the
present avian influenza H5N1 strain in Asia and Europe does not have
the capability of sustained person-to-person transmission, we are
concerned that it could develop this capacity. Because early detection
means having more time to respond, it is critical for the United States
to work with domestic and global partners to expand and strengthen the
scope of early-warning surveillance activities used to detect the next
pandemic.
Thank you for the opportunity to share this information with you. I
am happy to answer any questions.
Senator Specter. Thank you very much, Dr. Gerberding. We'll
now proceed with questions by Senators on 5-minute rounds. Dr.
Gerberding, it is estimated that some 50 million people died in
the pandemic in 1918. I know it is a delicate line to tread on,
not over alarming people and at the same time, putting people
on notice that there is a potential problem, that when we talk
in terms of the kinds of deaths which occurred in 1918 and very
substantial deaths in other times, the most recent pandemic in
1968, how would you assess the risk factor that we will have a
pandemic and that it will be a serious health problem in the
United States?
Dr. Gerberding. History teaches us that pandemics do
happen, and we need to expect one. We can't say that H5N1
influenza will be the cause of the next pandemic, and there is
no way to really predict that. What we can say is that compared
to 1918, we're dealing with a virus that is similarly lethal.
We're dealing with a society that's much more mobile and
can get from one corner of the world to another overnight, but
we're also dealing with a society that has the capacity to plan
and prepare and develop countermeasures and provide state-of-
the-art medical treatment if we prepare in advance for how we
could that.
So, the connection of worst-case scenario virus in a highly
connected population, but also a system that is taking the time
and the steps to prepare may put us in a position where we will
be able to at least delay or slow down the impact of a future
pandemic.
If we stay the course and get all of these things
accomplished, we are really in a position in the future to take
the threat off the table.
Senator Specter. Dr. Agwunobi, the President asked for $7.1
billion. We have come forward with $3.3 billion for the
agencies within the jurisdiction of this subcommittee. Would a
greater appropriation this year enable the Federal Government
to do more now? Or stated differently, do you really need more
money at this time?
Dr. Agwunobi. The President and the Secretary came up with
that figure following extensive planning and thinking through
what it would take----
Senator Specter. I only have 5 minutes. Do you need more
money now?
Dr. Agwunobi. Sir, this first-year funding is absolutely
welcomed.
Senator Specter. No--no, do you need more money now?
Dr. Agwunobi. As I said, sir, clearly, the President and
the Secretary have a plan. This first-year funding was very,
very gratefully received. We're going to work to make sure that
it's extended----
Senator Specter. Oh, wait a minute. I'm sure it's
gratefully received, but is it adequate?
Dr. Agwunobi. Sir, we continue to stay the course. Sir, our
plan is to expand the $7.1 billion.
Senator Specter. Dr. Gerberding, when we move ahead to
vaccines, how much do we need by way of vaccines, and when will
we have an adequate supply for this country?
Dr. Gerberding. We are not going to have a rapidly
available adequate supply for several years even if we do
everything we want to do with the $7.1 billion. It's going to
take time to build that production capability, and we've got to
modernize the vaccine so we don't depend on eggs. So, I would
estimate 4 to 5 years at best to get where we need to be.
Senator Specter. On the antiviral drugs, what is the
projection for an adequate supply of antiviral drugs?
Dr. Gerberding. That's a tough one because we have to make
some speculations, but our target is 25 percent coverage of our
population based on the best models that we have.
Senator Specter. When will we get there?
Dr. Gerberding. We estimate, based on what the manufacturer
of Tamiflu has represented to us, that we would have that
supply by 2008.
Senator Specter. 2008?
Dr. Gerberding. We estimate that with the investment you
just made, we would have enough to cover 20 million Americans
in 2006.
Senator Specter. It's possible that this pandemic could get
here long before 2008, isn't it?
Dr. Gerberding. Yes, it is possible.
Senator Specter. Dr. Gerberding, we covered this at the
hearing that we had last November 2, and I still haven't gotten
an adequate answer. But we saw this problem going back to 1996,
and should we have done more in 1996 and 1997 and 1998, that's
10 years ago, to be in a better shape than we are today for
this very serious, potential problem?
Dr. Gerberding. Absolutely.
Senator Specter. Well, it's not a satisfactory situation we
find ourselves in now, but I'm out of time, so I'll yield to
Senator Harkin.
Senator Harkin. Thank you very much, Mr. Chairman. It was a
great line of questioning. I want to ask Dr. Agwunobi that you
mentioned in your testimony only cell based and egg based. In
the amount of money in the document we have here on your
funding you have accelerate cell-based vaccine and then buy
courses from existing egg-based manufacturers.
I had in my office, I think, what, 2 weeks ago maybe, an
individual informing me of another process using recombinant
DNA, which is even faster. Well, at least according to them, I
mean, I'm not--I approach it from a non-scientific basis,
obviously, but in going through the steps that were necessary
and the fact that these labs can be mobile, that they can be
set up anywhere, I'm curious as to why you're not looking at
recombinant DNA or any egg based vaccines.
Dr. Agwunobi. The fact that this is--there's a need for us
to rapidly develop capacity forces us to look first to those
existing situations where we know we can expand as quickly as
possible, but it's not at the exclusion of science.
Indeed, we continue to work through our scientists, both at
CDC and NIH and with industry, to look for other opportunities
over time. Our investment today is focused, however, on finding
the fastest ways to use existing industrial technology,
existing opportunities to expand.
Senator Harkin. Cell based is not existing.
Dr. Agwunobi. There are some industries--there are some
companies within the industry that have already begun the
process of rolling out their cell-based capability. Clearly----
Senator Harkin. What can you tell me about RNA based?
Dr. Agwunobi. There is some science that would indicate
that it is potentially one of the options we could use going
forward. Now, we haven't ruled it out----
Senator Harkin. Have any vaccines ever been developed using
RNA based?
Dr. Agwunobi. I'm not sure that I know of any specific, but
I believe there are. There are some.
Senator Harkin. I think that's true.
Dr. Agwunobi. I believe there are.
Senator Harkin. I think that's true. At least, that's what
I'm told. I don't know. I mean, I don't know. I have--I'm
asking the experts here.
Dr. Agwunobi. That's true.
Senator Harkin. I was told that there have been RNA-based
vaccines. Oh yeah, hepatitis for hepatitis.
Dr. Agwunobi. Yes, I believe there are and----
Dr. Gerberding. Yellow fever----
Senator Harkin. Pardon?
Dr. Agwunobi. Yellow fever and others.
Dr. Gerberding. Yellow fever is another RNA virus vaccine.
Senator Harkin. Well, you know, a virus is a virus. I mean,
they're not all the same, obviously, but it would seem to me
that the same kind of RNA-based production for these kinds of
viruses, at least what I'm told, could be rapidly used for the
production of the flu-based viruses.
Now again, I'm not a scientist. I can't speak to that, but
if all of this is true, I'm just curious as to why you're not
putting some money into RNA based. Why not? You don't have one
cent in there.
Dr. Gerberding. The NIH is supporting research that is
looking at all of these recombinant technologies for----
Senator Harkin. So, it's coming through NIH somewhere?
Dr. Gerberding. Yeah, the research program there, and we
also are working on how to build the recombinant seed virus
strains that we would use for a large-scale vaccine. So, that
technology is moving forward.
Senator Harkin. Well, that's reassuring because if--is it
true that if, in fact, this proves to be a viable methodology,
that the timeframe then, you're talking less than 4 to 6
months, you're talking a matter of a couple of months is what I
was told, in terms of ramping up and getting the vaccines
developed.
Dr. Agwunobi. I think our strategy is to diversify as much
as we can. Through advances in science, hopefully, one of our
goals will be to shorten that time period.
Senator Harkin. Well, I mean, I need more information, and
maybe I'm just getting ahead of my schedule about what NIH is
doing in this area. Excuse me, but we really have to push ahead
on that.
Dr. Agwunobi, your pandemic flu plan would require States
to pay 75 percent of the costs of the antivirals over and above
the 26 million courses to be purchased by HHS. Your latest
budget figures expect that States will spend $340 million to
purchase antivirals. Where do you expect the States to find
this money?
The $350 million provided in the DOD bill is meant
primarily for the planning and exercising of pandemic response
plans. It raises the question if one State finds itself unable
to meet these objectives, doesn't this place all Americans at
risk since the pandemic's not just going to stay in one State,
it's going to move across State lines?
Dr. Agwunobi. I think it's important that we first State
that the absolute number of antivirals on hand is a poor
indicator of preparedness. It doesn't equate to preparedness. A
diversified strategy is important.
Having said that, our first step is to provide 20 million
doses--treatment courses rather, of antivirals to the States
paid for 100 percent by the appropriation that we were given.
The second strategy is then to allow States, if they wish, to
augment that amount with this subsidized, 25 percent subsidized
option.
In addition to that, States can also go one step further
and purchase on our contract amounts of antivirals in excess of
the subsidized and the 100 percent paid for Federal allocation
of antivirals that each State will receive.
The bottom line is that States will have three options to
add to and increase. Every State will receive antivirals in our
plan.
Senator Harkin. I know I'm out of time. I just have one
question for Dr. Gerberding. How many people do you have on the
ground? How many people do you have? Do you know? If you don't
know right now if you--in Vietnam, Cambodia kind of, and do you
have any people on the ground in China?
Dr. Gerberding. We have people on the ground in all of
those countries. I can't tell you exactly how many are in the
priority countries right now, but we intend to put more people
there. Yes, we do have people in China.
Senator Harkin. Turkey?
Dr. Gerberding. We have CDC scientists in Turkey in the
association with the WHO team and, I believe, an additional
person working in the lab in Istanbul.
Senator Harkin. Thank you very much, Dr. Gerberding.
Senator Specter. Thank you, Senator Harkin. Senator Gregg.
Senator Gregg. Thank you. Thank you, Mr. Chairman. Let me
join in your praise of Dr. Gerberding's work. Enjoyed working
with her as Chairman of the Health Committee and she's an
exceptional challenge for our Government. Doctor, let me ask
you a couple of quick questions, and then I will move on here.
But on quick preparation questions, I've been to a couple of
meetings, you know, symposiums on this issue, and one thing
that everybody seems to think it can be done quickly, should be
done quickly, is get up to speed with what you'd call basic
medical gear. You see those people with facemasks in your
picture there. So, do we have enough facemasks, because they're
produced out of the country and if there were an epidemic
they'd be hard to get, and do we have enough facemasks? Do we
have enough hypodermics in storage and in staging areas to
handle an epidemic?
Dr. Gerberding. We are still purchasing. We have enough in
terms of the use that would be required to actually provide the
medical care and treatment, but the reality is everyone will
want a mask.
Senator Gregg. When do we get----
Dr. Gerberding. So, there's going to be a run on----
Senator Gregg. How far do we come--how far are we from
getting enough?
Dr. Gerberding. In the money that was just appropriated in
the President's emergency supplemental, we're going to spend
$242 million to augment our stockpile with those items. We're
going to need to continue to buy those over time. We're----
Senator Gregg. We buy them all overseas, I presume. They're
all manufactured in China probably.
Dr. Gerberding. Most of the manufacturing is offshore. So,
for us, stockpiling makes sense because otherwise, we might not
be able to secure what we need in the time of a pandemic.
Senator Gregg. All right. That's what I mean. We have to
have it here because we're not going to get it if there's a
worldwide epidemic. They're not going to sell it to us. They're
going to keep it themselves.
Dr. Gerberding. Absolutely.
Senator Gregg. But we are going to have enough by, say
when, June?
Dr. Gerberding. I'm not going to commit to that because I
think, again, enough--one of the things that's going on is our
scientists are studying if masks can be reused and how should
masks be used. The $50 million toward CDC research that's in
the appropriations is going to ask and answer these very
practical questions so that we can have a better evidence base
for planning and how much we need.
Senator Gregg. Could you get me a--I'm going to--I don't
have much time. Sorry to be abrupt, but can you get me a letter
that explains the timeframe for getting adequate supplies on
what you'd call basic medical supplies?
Dr. Gerberding. Absolutely.
Senator Gregg. Second, another thing that's been mentioned
in these meetings has been the capacity to quarantine at the
borders. Do you have all the legal authority you need to
quarantine at the border, number one? Number two, do we have--
have we set up the regime to accomplish that?
Dr. Gerberding. I just visited one of our quarantine
stations yesterday, so I can assure you that we are getting
prepared there. We do have the legal authorities to quarantine.
We have worked out the agreement with the Department of
Homeland Security on who will enforce our authority because
CDC, obviously, is not an armed service. So, we need the law
enforcement component should we ever require that additional
protection.
But I think, in general, as these systems are put up and
exercised, we're discovering that this voluntary opportunity to
evaluate, assess and isolate people is working quite well.
Senator Gregg. I'd also appreciate it if somebody and I
don't want to have your staff just spinning wheels, but as
chairman of the Homeland Security Committee, which mirrors this
committee on this issue, I'd like to know if we need to do
anything. So, if you could tell us, tell us.
Dr. Gerberding. Thank you.
Senator Gregg. On a more philosophical level, the issue of
vaccines has been something that we've been struggling with.
We've been struggling on it with bioterrorism. Now, we're
struggling on it with this. Is it not true that one of the
reasons we don't have the vaccines is that we basically
destroyed our vaccine industry in this country?
Dr. Gerberding. It's absolutely true. We've seen a
continued deterioration in the number of manufacturers and
their capacity over time.
Senator Gregg. It's gone from approximately 35
manufacturers to 3 or 4, and isn't that a function primarily of
the liability that manufacturers simply don't seem--feel that
there's enough return in considering the risk?
Dr. Gerberding. I think there's a component of liability,
but it's also a profit issue. Our manufacturers take a lot of
risk and----
Senator Gregg. Profit is a function of liability--of your
liability threat. I mean, if you're going to be liable for a
vaccine that may impact millions of people in an instant--in a
very instant period, and you've got no way of getting it to the
market because you can't sell it to anybody but the Government,
you're probably not going to produce that vaccine, right?
Dr. Gerberding. I think manufacturers want a fair profit,
and liability can certainly be a deterrent from their
confidence in acquiring that.
Senator Gregg. So, if we're going to get our vaccine back
on--vaccine industry back up and running, we're going to have
to, and we have tried to address liability, and we're going to
have to address revenue, but what we've seen so far is that we
put revenue into the stream through bio--the bio, what, biotech
effort. We put $5.6 billion in the stream. Now, we're going to
put $7 billion into this stream for influenza potentially. Are
we going to get a vaccine industry back up and functioning in
this country as a result of those dollars, do you think?
Dr. Gerberding. My understanding that when the President
asked for the $7.1 billion, a major focus of that investment
was to do everything we could to get the vaccine industry up
and running for influenza.
Senator Gregg. Well, how is it going to happen? I mean, we
are we going to see pharmaceutical companies engaging in the
production of vaccine in this country, or are we still going to
have to buy it from France and----
Dr. Gerberding. We are seeing that. We are certainly seeing
of the one manufacturer who's domestically based a willingness
to commit to infrastructure and building capacity for vaccine
production. We also, this year, have four manufacturers in the
game as opposed to two manufacturers that we had 2 years ago.
Senator Gregg. How many are American based?
Dr. Gerberding. Only one of the four is American based.
Senator Gregg. But don't we need this production in the
United States because if there's an influenza outbreak in the
world, and the production isn't in the United States, we're not
going to have first call on that, right?
Dr. Gerberding. Absolutely. We believe that for all of the
essential countermeasures.
Senator Gregg. So, how do we get more than one vaccine in
the--participant in this effort?
Dr. Gerberding. Some of the investment that is included in
the appropriation is going to be used to try to motivate
additional manufacturers to come around the table. I know
Secretary Leavitt and the President have met with the large
list of manufacturers to see what else we need to do to get
them collaborating. It's been an impressive commitment to scale
this up, and I believe that our industry and our Government is
working together to accomplish this, but it just can't happen
fast enough. We also have to modernize what we're doing, and
that's the other lane here to bring modern technologies faster
to the marketplace.
Senator Gregg. I think the one thing we can, and I know my
time's up, I think the one thing we can take a little comfort
from is that we got really talented people in your
organizations working on this, and there is a focus on it.
That's good, and hopefully we can get some results. We know it
takes time, but we don't have a whole lot. Thank you.
Dr. Gerberding. Thank you.
Senator Specter. Well, thank you, Senator Gregg. As you can
see, Dr. Gerberding and Dr. Agwunobi, there's a lot of concern
here as to how fast we're moving on these critical issues and
what you need. There are only four of us here today, but
there's a fair amount of clout.
Senator Stevens, who will have the next line of
questioning, was former chairman of the full committee and
chairman of Commerce, and Senator Gregg is chairman of the
Budget Committee and chairman of the Subcommittee on Homeland
Security. You know where Senator Harkin and I have been.
We want to be helpful to you, but we have to know what you
need. When I ask if the money is adequate, I really want to
know if the money is adequate and whether you are able to
maximize activities at this time because when the President
asks for $7.1 billion, then we give him $3.8 billion, there's a
big gap. Now, maybe that's all you need at the moment. Now,
there is some talk that that's as much as you want in the year.
But you are high-level professionals, and we want to know what
we can do to help you, but we can't do it unless you tell us.
Senator Stevens.
Senator Stevens. Well, Mr. Chairman, we tried. I've got a
series of questions. First, when I was home, I had a meeting in
Alaska with the people who were doing the testing of the
migratory birds. I was very surprised that there's no
laboratory in our State that can analyze those tests. They go
down to Michigan or somewhere and eventually down to CDC
headquarters. About 2 months later, maybe 3 months later, we
find out whether these birds that have just come through are
infected.
Why is there no laboratory up there? This is a massive
amount of these birds that come into our State. In addition to
that, we have half the cargo that comes in by air comes through
Anchorage now, and we have the massive travel of people from
Asia coming through in our passenger's planes. I find that
strange to think it takes so long to deal with this testing.
Why is it?
Dr. Gerberding. The tests that you're talking about are
actually not done at CDC. They're done by the U.S. Department
of Agriculture at the University of Georgia, but we're fixing
that. In fact, the appropriation to develop centers of
excellence and other research relevant to human and animal
health that was included in this emergency supplement--one of
the things we want to do with that is get in the business of
being able to test for these birds and test them faster. So, we
will address that.
Senator Stevens. Unfortunately, it's one of those things we
tried to get that lab up there to speed up this process. From
what I was told, there's no hope for it. Is that right?
Dr. Gerberding. I disagree with that, and I think we do
have a laboratory in Alaska through our laboratory response
network, and we are training laboratorians to be able to test
for H5----
Senator Stevens. There's no laboratory. The specimens go
down somewhere to Michigan and then go down South. By the time
the people that are testing the birds, those--they don't get an
answer back for months.
Dr. Gerberding. I can't speak for the USDA or the
Department of the Interior's project, but I can commit to you
that CDC intends to be able to test in Alaska, and we are
already able to do that for human infection. We can expand
that.
Senator Stevens. Okay. I had the task of managing that bill
that had this money in it. I congratulate the Senators here,
Senator Harkin, Senator Specter, for their advocacy to get the
money that we did get.
I'm disturbed we didn't get the full amount, but the
problem that I have is at the last minute, we did put in the
provision concerning the liability portion of that bill. Has
that liability portion been analyzed by your people? Is it
adequate to give assurance to the manufacturers that they will
move forward and have an American-based manufacturer of the
vaccines?
Dr. Agwunobi. Staff and HHS are currently reviewing the
language very, very closely. We are, as we speak, issuing RFPs
and then requests for information to industry. We expect as
those responses come in, that we'll be able to analyze what the
actual and real impact of that language is on their responses.
It's a little early yet to tell what their response to that is
going to be.
Senator Stevens. Well, respectfully you know, that was in
December. We're approaching February, and had I been in your
position, I would have had a meeting in January of all of the
CEOs of the companies involved and asked them is this adequate.
Dr. Agwunobi. Sir, that----
Senator Stevens. Did you do that?
Dr. Agwunobi. Yes. Sir, as you know, prior to----
Senator Stevens. Did you do that?
Dr. Agwunobi. Sir, yes, we have met with industry, and they
indicated to us that the liability issue is a significant
roadblock to progress. That's what is----
Senator Stevens. But that's not my question. What about the
adequacy of what we put in the bill? Is that adequate to give
the assurance to the industry that they can have the liability
protection?
Dr. Agwunobi. Sir, my understanding is that as they respond
to the RFPs and the RFIs that we'll have a better idea of that
particular answer.
Senator Stevens. I don't find that acceptable, Doctor. I
think the timeframe on this is so short that we ought to know
now whether we have to proceed in the next supplemental to
improve that liability provision, and it won't do us any good
if we get that in July.
We're going to move a supplemental some time in March or
April. If that's not adequate, the threat of this pandemic is
so great we ought to move to see if we can give the assurance
to the American manufacturers of vaccines that they will have
the protection that they demand in order to bring that industry
back here.
Now from me, I do believe that that's your responsibility,
yours and the Department of Health and Human Services'. Now,
can we get any assurance at all we'll know whether that
liability provision is adequate?
Dr. Agwunobi. Sir, it shouldn't take long. We are expecting
responses very quickly hereafter. In our dialogue with the
industry at that level, we'll be able to ascertain very quickly
as to whether or not it's enough.
Senator Stevens. Madam Secretary, what do you think?
Dr. Gerberding. I'm not an expert in liability, but I do
think that urgency is important because we have to get the show
on the road.
We know that if we'd had the full appropriation, we
probably could have reassured industry, and they would have
been willing to move forward faster. You'll hear from them on
the next panel whether or not our current situation is
providing any additional barriers. But liability is one thing
that several have cited as an issue, and we've got to get it
out of the way.
Senator Stevens. Well, I'm not as disturbed about not
getting the full amount as other people because we did as much
as we could in that one bill. There is a problem of budget
control and what not. I think we'll get the balance of that
money early this year if we get the assurance that, if putting
it up will make the difference. Now, I don't think we'll get it
unless we get that assurance. Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Stevens. As you hear
the sense of urgency in Senator Stevens' questions and Senator
Stevens' tone, and there's no doubt that we're on a short
timeframe. We understand that you're focused on it, but we want
to help you. When Senator Stevens raises the issue of adequacy
of the liability issue, you've got to get some hard answers. We
do have people coming in today to tell us about it, but we
shouldn't have to wait until the subcommittee convenes a
hearing. We've talked to Secretary Leavitt about it, and he's
going to be coming in for the appropriation of the full
department. We're going to be emphasizing this again, but may I
compliment you, Senator Stevens, on the tone of your questions
and the tone of your urgency.
Senator Stevens. Mr. Chairman, my mind goes back to that
night that was really very early in the morning when we had
these arguments before, and I got you somewhere, I think, out
of bed, probably on the telephone, and we have had the sense of
urgency then. That was December. I still have that sense of
urgency from the conversations I had at home. I hope we'll see
some progress here before we mark up the first bill.
Senator Specter. Senator Harkin seconds that motion, and
Senator Harkin wants to be heard some more.
Senator Harkin. Yes, Mr. Chairman. Look, I had not raised
the issue of liability, but since it's been raised, I want to
weigh in on it. I believe that there ought to be some form of
limited liability to the manufacturers. I think that's
appropriate.
But in all this talk about liability, what about people?
What about the individual out there that may get harmed because
of either an accident that can happen in the manufacture or an
accident in the delivery system or a carelessness on the part
of a manufacturer?
That may happen. We're all human after all. Someone gets
injured out there. Someone gets damaged. Well, if the
manufacturer has got all liability protection, and we don't
have a compensation package, what does that say to that person
out there that got vaccinated? We want people to get
vaccinated. We want them to have the assurance that if they get
damaged and they get injured, even if there's liability
protection of the manufacturer, there is a compensation package
to help them out.
As it is right now in the bill that passed the Senate and
the House and that the President signed, there's liability
protection for the manufacturers, blanket liability. Blanket
liability. There's zero. Zero money for any compensation to any
individual that's injured out there. What about people? We want
to assure people that they can get vaccinated without any fear,
but if they get damaged, if they get harmed, you know, due to
an accident, carelessness or whatever, there's going to be some
compensation for them. Where is that side of the equation?
Where is that side of the equation?
In the dead of the night, after the bill was passed, after
manager signed off on it, this liability protection was slipped
into the bill. Well, that's getting into the weeds on process
around here. I don't need to bore anybody with process, but
that's not the way to do things. We can have some limited
liability.
I'm going to ask the manufacturers when they get up here
about liability, but I want to ask them, and if you're sitting
out there, and you're coming up here, be prepared, I'm going to
ask you about compensation for people, not just protecting your
company and your shareholders and your stockholders, but what
about the people out there. How about giving them compensation?
I'd like to see the manufacturers be as adamant--as adamant in
saying yes, we want liability protection, but you must provide
some compensation for people out there that get damaged. I'd
like to see them as adamant about that, and I'm going to ask
them about it.
Senator Stevens. Well, Mr. Chairman, one last word. It'll
take at least 2 years for the vaccine process to come back to
the United States. There's plenty of time to deal with the
liability. The question is getting the manufacturers back here
now, and we can deal with liability. The timeframe for this
vaccine to get to anyone, to even be heard, is more than 2
years, so I don't accept the delay on proceeding with the
liability provision because of the lack of the compensation
provision.
I support the compensation provision. I think that there
should be adequate--but the question right now is do we have
the vaccine capability here, or are we going to be dependent
upon foreign countries releasing enough for us to deal with our
population. So, that's the bottom line.
Senator Specter. I think we're all on the same page here on
needing adequate protection for the companies so they proceed
at having adequate compensation for the victims. We didn't get
part B done because we were working very late. And we have a
compensation program, but there are too many ifs in it. There's
an if about a declaration of an emergency, and there's an if in
it on the appropriation of the funds. Those are two big ifs. We
do a lot of talking about what we're going to do, and very
frequently, the Congress is slow on doing it.
So that when Senator Stevens talks about the urgency of
getting assurances that the manufacturers will go forward, he's
right. When Senator Harkin talks about the necessity for having
adequate compensation, he's right. This subcommittee does a lot
of hearings, and we just may do a hearing on that subject as
well because if it wasn't all tied up when we dealt with this,
and Senator Stevens was at the core of it, and I was involved
in it, and Senator Harkin was too, but we've got a lot of
witnesses to cover and not very much time.
We very much appreciate your professionalism, Dr.
Gerberding and Dr. Agwunobi, and let us hear from you before we
summon you to another hearing. Senator Harkin wants to know if
there's a possibility of getting one last fast question--I
don't think so, Senator Harkin. We can have a question. I don't
know that it'll be fast, but----
Senator Harkin. Very quick, the Turkey--the outbreak in
Turkey, I understand that the strain of flu found in Turkey
includes three mutations in the virus's sequence that may make
it more likely to be transmitted to humans. Is this true, and
can you explain this very briefly?
Dr. Gerberding. CDC has that virus right now, and we're
studying it ourselves. But based on what we know from others,
there are some signature mutations that have been associated
with more affinity for humans. Whether or not that will prove
to be true when we look at the actual virus in cells or in
animals, it's too soon to speculate. So we are concerned, but
we don't have the data yet to fully answer your question.
Senator Harkin. Thank you.
Senator Specter. Thank you, Doctor Gerberding. Thank you,
Dr. Agwunobi. We're now calling Mr. John Barry, Dr. Richard
Webby, Mr. George Abercrombie, Mr. Daniel Soland, Mr. Chris
Viehbacher, Dr. Mary Mincer Hansen, Dr. Calvin Johnson, Dr.
Bruce Dixon and Dr. Joanne Godley.
We have a very limited amount of time, and I know you have
been advised as to the limitations on your presentations. We
would ask you to stick within those time limits, which you have
been advised about so that we can leave the maximum time for
questions for the panel on matters of specific interest to the
subcommittee.
Our first witness is Dr. John Barry, author of ``The Great
Influenza'', the epic story of the deadliest plague in history,
author of four previous books, including the award-winning
``Rising Tide: The Great Mississippi Flood of 1927 and How It
Changed America''. Mr. Barry is a graduate of Brown University
with his bachelor's degree. Thank you for coming in, again, Mr.
Barry. I think you ought to know at the start that my wife has
bought several copies of your book to distribute to our
friends. She is very concerned about this issue and is really a
very heavy motivating force, and she just got complimented by
Senator Harkin. Mr. Barry, the floor is yours for 5 minutes.
STATEMENT OF JOHN M. BARRY, AUTHOR, ``THE GREAT
INFLUENZA''
Mr. Barry. Okay, well, thank you very much for asking me
back, and I appreciate your wife's support. I think I'll
probably take less than 5 minutes in the effort to save time
and skip over most of the historical background. As you already
said, according to a Nobel Prize winner, at least 50 million
people died in 1918 and 1919. That was in a world population
only 28 percent as large as today's. I think it's very
important to note that a significant proportion of that, we
don't know exactly how many, but perhaps one-third to almost
one-half of those people died directly from the virus so that
modern medicine, antibiotics and so forth, would not have had
any effect.
Also, in the 1957 pandemic, 25 percent of the population
died directly from the virus, which of course, you know,
emphasizes how important a vaccine is since other medical
technologies would be useless and also, of course, more
research on antivirals. We don't really know how effective
Tamiflu would be. We also don't know whether or not the virus
would develop resistance to it.
I do want--I'm not an expert on the preparedness plans that
the States have developed or for that matter, the Federal
Government, although I certainly have familiarity with it, but
I would like to make a couple of observations. I've
participated in quite a few meetings in the last 1.5 years,
workshops and so forth, on preparedness, most involving Federal
agencies, but a few States, I do want to talk about two, what I
think, are larger problems that I see as potential gaps. The
first involves the lack of thinking about the wave phenomenon,
the first wave, second wave, third wave.
There is some debate in the scientific community whether or
not this virus actually did come in waves or whether they were
different viruses. We've never seen another influenza pandemic
where there were successive waves that followed upon each other
so rapidly. We also haven't seen a lot of change in virulence
in other viruses as we saw in 1918. This is not really an
academic question. This is a very concrete question. Because
you have a very different containment and communication
strategy if when the virus first enters the human population as
a human virus, it starts out as virulent as it's ever going to
get. As opposed to what seems to have happened in 1918, that it
starts out as really a very mild virus that looks absolutely no
different from a normal influenza, and endemic influenza in
terms of clinical illness, and then over a period of time
becomes virulent.
Given the media attention, the firestorm that would erupt
when we identify the next pandemic virus. You know it's very
important if it starts out mild and becomes virulent and I
don't think enough attention has been addressed to that wave
phenomenon. Even if--we will never know probably for certain
whether or not it was the same virus evolving, my own sense of
the historical data, I feel somewhat qualified to look at this,
because this is not strictly a laboratory question at this
point. It really involves historical data, and I think I'm more
familiar with historical data than many of the scientists who
have weighed in on this subject. To me it does look like the
same virus.
The other thing is I'm a little bit concerned about
integration of planning. For example even--first I want to
start off by--which I do commend this committee for its
attention to what I consider maybe the most serious threat to
American lives and economic well-being that we face at the
moment. I also commend this administration, I think they are
trying to get ahead of the curve and as someone whose home is
in New Orleans, I recognize how important planning and
preparation is.
But having said that in terms of integration, even at HHS,
for example, the communication strategy which in a pandemic is
absolutely crucial. I mean in 1918 a very sober scientist not
given to overstatement said if this continues for a few more
weeks, ``Civilization could easily disappear from the face of
the Earth.'' That was I think intimately an outgrowth not only
of the fear from the disease but from the poor communications
strategy of all Government officials in 1918.
So I think the communication strategy needs--the people in
charge of emergency preparedness at HHS, who I have very high
regard for Stewart Simonson, are not intimately involved in
developing the communication strategy. I find that troublesome.
I think that's the last comment I'll make on my prepared
remarks. I do want to weigh in a little bit on the liability
issue. One of the meetings that I participated in----
Senator Specter. Mr. Barry, could you summarize at this
point because you're over time.
PREPARED STATEMENT
Mr. Barry. Okay. I thought I was--I was in a meeting which
involved seven vaccine manufacturers including the CEOs of
three or four companies. These were international companies,
some in the United States, some overseas. The issue of
liability was discussed, and what one of the CEOs of a U.S.
manufacturer said is that ``Liability is an irritant, it's not
the biggest problem. The biggest problem is demand.'' So
Senator Harkin's bill addresses that and I think that's an
important part of the equation.
Senator Specter. Thank you very much, Mr. Barry.
[The statement follows:]
Prepared Statement of John M. Barry
I thank you for the opportunity to testify, and to provide you with
some background on a disease that, according to the Centers for Disease
Control and Prevention, kills 36,000 Americans in a normal year. By
definition, an influenza pandemic would not be a normal year; it would
kill far more Americans than that.
I also want to commend this committee and this administration for
trying to get ahead of the curve, to anticipate and plan for this
serious threat to American lives and to the American economy. Now, we
are here to discuss planning and preparedness.
However, since my home is in New Orleans and because of some
personal involvement in flood control issues, I am well aware that
anticipation and planning are not enough. Few disasters have been as
well described in advance and as often warned about as Katrina, and yet
Katrina happened.
Nature is perfect. Man is not perfect. Whenever a raging nature and
humans collide, if humans make a mistake, nature will find it, and
exploit it.
In the case of Katrina and New Orleans, we now know that human
error, a serious design flaw in levees designed and constructed
entirely by the Federal Government, caused the devastation of that
city.
Obviously, in a conflict with an influenza virus, many more lives
will be at stake than in Katrina. It will not be possible to eliminate
mistakes, but we must exert every effort to minimize them. Oversight
matters.
The first thing I want to do is give you some historical
perspective on the disease. Then I'd like to make some comments about
two areas that concern me.
HISTORICAL BACKGROUND
Influenza viruses are all bird viruses, not human viruses. But the
virus mutates very rapidly and has some unusual genetic features which
allow it to jump species to humans and other mammals. A bird virus can
become a human virus--meaning that one person can infect another--both
directly and indirectly. This ability to jump species makes it
virtually inevitable that the virus will do so again.
We have no idea when the next pandemic will occur. It may have
started 2 weeks ago and we just don't know it yet, or it may not come
for 20 years. But for at least the last 500 years, pandemics have
occurred three to five times a century, with the greatest duration
between pandemics of 42 years. We are now at 37 years and counting. In
several pandemics the virus has been quite lethal.
The most lethal pandemic that we know some details about occurred
in 1918 and 1919. No one knows how many died, but Nobel laureate
Macfarlane Burnet, who spent most of his career studying the disease,
believed that the death toll was at least 50 million people, and
possibly 100 million. This was in a world whose population was only 28
percent as large as today's. That is the equivalent of 175 to 350
million today. Yet even without adjusting for population and using
Burnet's lower estimate, the 1918 influenza pandemic killed more people
in 24 weeks than AIDS has killed in the 24 years that disease has been
known. Well over half the deaths occurred in an incredibly short span
of about 10 weeks, between late September and early December, 1918.
In the developed world, the overwhelming majority of victims
suffered what we would today regard as a typical attack of the disease.
For example, the case mortality rate in the United States was no more
than 2 percent. But influenza attacks so many people that the U.S.
death toll was an estimated 675,000, the equivalent of about 1.8
million today. But it is also important to realize that the virulence
of the virus varied enormously from one town to the next, and from one
country to the next; the continental United States was by no means
among the hardest hit countries.
Even so, virtually every city, town, and village in the country ran
out of coffins. People could die less than 24 hours after their first
symptoms.
Federal, State, and local officials tried to reassure the public
instead of telling anything close to the truth, people saw for
themselves and what they were being told destroyed all trust in
authority. People became alienated. In city and country victims starved
to death ``not from lack of food but because the well are afraid to
help the sick.'' Streets emptied. In Philadelphia in a city of almost 2
million people, one medical student who was in charge of an emergency
hospital saw so few cars on his way home every night over a drive of 12
miles that he started counting them; one night he saw not a single
other car on the road, and wrote, ``The life of the city has almost
stopped.'' Doctors and nurses were kidnapped. A confidential Red Cross
report noted ``a fear and panic akin to the terror of the Middle Ages
of the plague.'' One sober scientist, not given to overstatement, wrote
that if the epidemic had continued ``for a few more weeks, civilization
could disappear from the face of the earth.''
Particularly vulnerable were isolated populations. In Western
Samoa, where we have good statistics, 22 percent of the entire
population died. In Alaska and Labrador, an estimated one-third of the
native population died.
More than half the dead were healthy young adults, people who are
normally least susceptible to infectious disease. What little hard data
we do have suggests that between 4 percent and 8 percent of the world's
young adult population died.
It is also worth pointing out that, although the precise numbers
are unfortunately soft, it is quite conceivable that between one-third
and one-half the deaths came directly from the virus. We have better
numbers for the 1957 pandemic, and in that outbreak it seems that 25
percent of the deaths came directly from the virus.
This is an important fact. Even if we had adequate supplies of
existing antiviral drugs, which we do not have, we do not know how
effective they really are, and the virus could very well become
resistant to it. Since a pandemic would quickly fill all beds in
intensive care units, we would quickly return to nature. Much of modern
scientific medicine would have no impact on the disease until a vaccine
became available.
Finally, we must recognize that influenza is one disease to which
we have actually become more vulnerable than we used to be, not less.
Medical developments have not kept pace with changing demographics. In
addition, our economy has shifted to ``just-in-time'' inventory. In all
sectors of society we have far less slack, which in effect translates
into surge capacity, than we used to have; this is true from hospital
beds to groceries--and to coffins.
In short, influenza is a serious threat, arguably the most
dangerous threat we now face, both to American lives and economic well-
being.
CURRENT PLANNING
I'd also like to make some comments about current planning. First
let me say I was a little reluctant to testify because I do not purport
to be an expert on Federal preparedness efforts, much less the plans
being drawn up by the various States. But committee staff did convince
me to come because you might have some questions for me that I am
qualified to address.
Having said that, I have participated in quite a few meetings on
influenza in the past year and a half involving Federal agencies or the
National Academy of Sciences, and I have had a handful of conversations
with public health leaders in several States. This experience has led
me to tentative conclusions about two things that concern me.
The first is what seems to me to be inadequate preparation for the
possibility of the pandemic coming in waves, particularly if the first
wave is a mild one that does no more damage than endemic influenza, but
that creates a media firestorm as soon as we have evidence that human
to human transmission has occurred.
This is a complicated question. The 1918 pandemic seemed to come in
three waves in rapid succession, far more rapid than any other
influenza pandemic we know about. It also seemed to change in
virulence, which also is unusual.
As a result, there is now some debate in the scientific community
whether in fact the waves resulted from the evolution of the virus, or
what seemed to be waves actually reflected almost simultaneous attacks
by different viruses.
I am a historian, not a scientist. I have the highest regard for
some of the scientists who have raised this question. Unfortunately,
the only way we can know for certain is if we find and compare samples
of viruses from the first, second, and third waves. That may never
happen. Even if it does, in the meantime, we have only historical
evidence.
I believe I am more familiar with a wider range of the historical
data than many of the scientists who have raised this question, and I
think the historical data does favor the interpretation that we faced
only one virus in 1918, that it did evolve, it did change virulence,
and it did so quite rapidly. Indeed, in 1918, medical journals
published articles as late as July suggesting that the disease being
reported could not be influenza because it was too mild, with too few
complications. Only a few weeks later, medical journal articles said
the disease could not be influenza because it was too lethal.
This question becomes more than an academic one when we think about
how to respond to the first reports of human-to-human transmission, and
as a new pandemic virus begins to spread.
If the virus starts out as virulent as it will ever get, that's one
thing and calls for one containment and communication strategy.
But if it starts out as a virus so mild that it is clinically
indistinguishable from endemic influenza, and it takes 6-8 months to
become virulent, that may call for a different containment strategy. It
will certainly require a different media strategy.
From the workshops and conversations with planners that I know
about, insufficient attention has been focused on this problem.
My second concern is a lack of integration of planning. This of
course is always a problem. Going back to Katrina, yesterday's
Washington Post reported that immediately after the hurricane struck
the Department of Interior offered FEMA boats, aircraft, law
enforcement officers, and other resources. Only some of these resources
were ever deployed, and only after long delays. Earlier the Department
of Transportation had reported a similar experience. This problem is
only compounded when State and local governments become involved.
Regarding the States's relationship with the Federal Government,
I'm not sure what more the Federal Government can do besides what it is
trying to do. Secretary Leavitt is trying to make it crystal clear to
each State that they need to prepare themselves. They are not all
getting the message.
But I'm also concerned about integration even within HHS. Let me
say that I have high regard for both Secretary Leavitt and Assistant
Secretary Stewart Simonson. And I am not just saying that out of
courtesy. I mean it.
Nonetheless, in my opinion the people developing the communications
strategy are not coordinating closely enough with the people actually
planning the agency's emergency response.
In a pandemic, 1918 clearly demonstrated that the communications
strategy is absolutely crucial to containing fear and keeping society
functioning. It is not an after-thought, it is an essential.
Thank you very much.
Senator Specter. We turn now to Dr. Richard Webby, member
of the Department of Infectious Disease at St. Jude Children's
Research Hospital in Memphis, bachelor's and Ph.D. from
University of Otago in New Zealand. You are a colleague of Dr.
Robert Webster, Dr. Webby, correct? He was a renowned expert,
hard to find unless you have a direct line to Hong Kong I
understand. You have 5 minutes, Dr. Webby.
STATEMENT OF DR. RICHARD WEBBY, PROFESSOR, ST. JUDE
CHILDREN'S HOSPITAL
Dr. Webby. Thank you Mr. Chairman, Senators, yes, Dr.
Webster is actually on a plane now to Hong Kong, so you'd also
need a line to the airplane as well.
I first want to spend a few minutes talking a little bit
more about the current situation from the angle of I guess
basic science, what the virus is doing, a couple of areas where
we really need basic research as well you know to help us
toward this goal of preparedness. Some of this information
we've already heard this morning, so I can go through some of
it fairly quickly.
The first is, and the most important fact is this virus is
still full entrenched throughout Asia, Europe, and a likely now
also moving into the Middle East. We certainly contend this
virus is likely in migratory birds, and I think in the
foreseeable future we're going to have to live with this virus,
it's not going away. Talking about human cases, this year we've
seen human cases in China, Indonesia, and in Turkey. More
recently a suspected case in Iraq, and some of these figures
are likely to increase as the WHO gets more information from
these current outbreaks, more samples and can confirm some of
the suspected cases.
Again that brings to the point that I want to spend a
little bit of time on, is Turkey and what we're learning about
the disease from the current outbreak in Turkey. How we're
learning that, is again through the total cooperation of the
Turkish authorities, as Dr. Gerderling spoke about this morning
there are WHO teams in Turkey, we're getting a lot of samples
coming out of that region in real time. You know some of the
information that this is showing us is, there seems to be a few
more perhaps mild cases, or ``A'' symptomatic cases of HDN1 in
Turkey. Whether that's a property of the virus itself, the
virus--I won't cover this again. The virus in Turkey is
different than the viruses in some of the other parts of Asia.
So whether it's a property of virus, whether it's a
property of the genetics of the host, or whether it's actually
a property that we're just getting access to samples, or
getting to people soon after they show symptoms, so we're
getting the best samples to detect these cases. Again some of
the data that was mentioned earlier, these particular changes
that the WHO have described. We would consider looking at the
sequence of these viruses in Turkey. They have signatures that
we normally see in human flu viruses as opposed to avian flu
viruses. We can do a lot of hand waving about what they mean,
but the bottom line is we really don't know. And as far as
adapting to humans, is that why we're seeing these plight of
human cases in Turkey, again we just don't know. We can
certainly do these experiments in the lab, but again that's
going to take having the funds to do those.
Again, moving onto the virus and to the expand a little bit
on that point I've talked about, that the HDN1 outbreak is not
one virus, it's actually a number of different viruses that
genetically, and are anti-genetically distinct. And in general
terms there's three groups of viruses out there, the viruses
from Vietnam, Thailand, are one group. The viruses from
Indonesia form another, and certainly the viruses that started
off in migratory birds, at least that's when we first saw them,
migratory birds in China are now moving through Europe, is
actually another group of virus.
So practically what does this mean, it means that we've got
to keep this in mind when making these preparations of these
pre-pandemic vaccines. Now will a pre-pandemic vaccine from a
virus in Vietnam, which is the virus that's a pre-pandemic
certainly in the United States at the moment, will that protect
against viruses from Turkey, will it protect against viruses
from Indonesia. Again, we don't--we don't really know. We need
a lot more basic research. This is not a the level of trials.
It's at the level of animal studies, to look at these cross
protection.
Also we need a lot more work, obviously the Holy Grail for
flu is a broadly reactive vaccine and there are approaches such
as a recombinant DNA approach that we heard a little about this
morning, that could potentially lead to that end. Unfortunately
they need--if that outbreak was here tomorrow, they need to be
up here, at the moment they're only down here, in terms of
development.
So the million dollar question I guess is with whether this
virus will gain the ability to transmit human to human, and I
know it's not a satisfactory answer, but the real answer is we
have no idea at all. Even amongst experts in the field--
actually I spoke to one expert in the field once and asked him
this question, what do you think about this, and his answer to
that was, you got more chance of getting kicked to death by a
duck. So I think that explains that even with the experts in
the field, there is a range of opinions about this virus.
PREPARED STATEMENT
What we do know is that a pandemic flu will occur, and that
this H5N1 virus is a very, very nasty virus. It's not your
ordinary run of the mill flu virus. It's highly pathogenic, and
certainly my opinion in terms of a disease right up there with
1918. Thank you.
Senator Specter. Thank you very much Dr. Webby.
[The statement follows:]
Prepared Statement of Dr. Richard Webby
CIRCULATION
The H5N1 viruses continue to circulate in avian populations
throughout Asia and parts of Europe. There are some unconfirmed reports
of infected avian species in the Middle East. The most recent activity
in humans has been reported in China (2 in 2006), Indonesia (3 in
2006), and Turkey (4 in 2006). These figures represent World Health
Organization confirmed cases and the actual number, particularly in
Turkey (up to 21), is likely to rise as suspected cases are confirmed
by reference laboratories.
TURKEY
The current outbreak in Turkey is receiving much attention. Due to
the total cooperation of authorities in Turkey and hence a strong
international presence, we are getting good information from this
outbreak. Some of the preliminary data suggest that, at least in
Turkey, there have been a number of asymptomatic or mildly affected
people. Whether this is a property of the extra surveillance here or a
difference in the viruses from Asian and Europe is still uncertain. It
is very likely that both are playing a role.
Data released by the WHO collaborating center for Influenza in Mill
Hill London shows that there have been some notable changes detected in
viruses isolated from Turkey. Of particular importance is a change
within a protein called the hemagglutinin. This change is more often
seen in human influenza viruses than in avian viruses and could
theoretically increase the binding of the avian virus for human cells.
Practically, the consequences of this change are really unknown, and
much more basic research needs to be done to examine this. Large scale
influenza virus sequencing efforts such as that of TIGR (NIAID funded)
and St Jude Children's Research Hospital are providing valuable
information to help address issues such as what factors are blocking
the effective human transmission of H5N1.
NATURE OF THE VIRUS
It should be stressed that this outbreak is not caused by a single
type of H5N1 virus. Although all H5N1, there are three distinct groups
of virus circulating. Generally speaking, and although there is much
variability even within these 3 groups, the viruses can be separated
into:
(i) many of the viruses from Vietnam and Thailand.
(ii) viruses from Indonesia and some from China.
(iii) viruses from outbreaks in wild aquatic birds in China, and
those moving through Europe.
Good progress has been made with developing potential H5N1
vaccines, but the practical consequence of the above is that new
vaccine reference strains will need to be produced (although we predict
that substantial cross-protection will be generated from those already
available) as the viruses continue to evolve. Recommendations on
reference strains will continue to be provided by WHO. Basic research
into more cross reactive vaccines and anti-virals should be encouraged.
SUMMARY
Unfortunately there is no way to predict whether H5N1 will become
pandemic in humans. The virus is still poorly infectious and
transmissible to humans and we do not know how it has to mutate to
change this. The only things that we do know are that flu pandemics are
inevitable and that this H5N1 is a particularly nasty virus. Regardless
of the direction in which it goes, expenditure of money to prepare
against H5N1 will help prepare for infectious disease emergencies
caused my many agents.
Senator Specter. We turn now to Mr. George Abercrombie,
president, CEO, Hoffmann-La Roche. Bachelors' degree from the
University of North Carolina, MBA from Harvard, the time is
very limited for your formal presentation, you have talked to
staff, and will have a chance to talk further. We've only
allocated 2 minutes Dr. Abercrombie. Proceed.
STATEMENT OF DR. GEORGE B. ABERCROMBIE, PRESIDENT,
CHIEF EXECUTIVE OFFICER, HOFFMANN-LA ROCHE
PHARMACEUTICALS
Dr. Abercrombie. Thank you Chairman Specter, ranking member
Harkin. I just want to share with the committee that my company
Roche is proud of our history of partnership with the
Government, and pandemic preparedness and response planning.
I'd like to highlight three key points, Tamiflu our product is
an effective influenza antiviral medication. Experts agree that
immediate access to Tamiflu and other antivirals are an
essential part of any plan to help control the spread of a
pandemic flu virus and my company Roche continues to accelerate
production of Tamiflu to fulfill pandemic orders world wide.
The HHS pandemic influenza plan calls for stockpiling at
least 81 million antiviral treatment courses. Enough to cover
about 25 percent of the U.S. population. However the Tamiflu
manufacturing process requires significant time and capacity
and therefore surge production at the time of the beginning of
a pandemic outbreak is not an option.
This is the reason why Tamiflu must be stockpiled in
advance of a pandemic, and positioned for rapid distribution.
Here in the United States Roche has filled pandemic stockpiling
orders totaling about 5 million treatments. Until last week we
were working under a letter of intent from the Government
seeking an additional 15 million treatments to be delivered in
fiscal year 2006. But last Friday at the end of the week, we
received a revised a projection from HHS, indicating that the
fiscal year 2006 stockpile purchases may total up to 46 million
courses of treatment. Now according to that letter 18 million
of the total would be purchased directly by HHS, 28 million
would be dependent upon purchase decisions made by individual
States.
We are ready to begin filling these orders as soon as we
receive the final contract, and we are committed to ensuring
that we can provide the full stockpile recommended to cover 25
percent of the U.S. population as outlined in the HHS plan.
PREPARED STATEMENT
However, given global demand we have sold Tamiflu to about
65 countries around the world, the U.S. Government must have
the resources required to make an immediate and sustained
contractual commitment for that full stockpile.
Senator, on behalf of Roche, thank you for highlighting the
importance of this critical public health issue, and I'm
pleased to answer any questions that you may have.
Senator Specter. Thank you very much Dr. Abercrombie.
[The statement follows:]
Prepared Statement of Dr. George B. Abercrombie
Chairman Specter, Ranking Member Harkin and Members of the
Subcommittee, I am George Abercrombie, President and Chief Executive
Officer at Hoffmann-La Roche Inc. (``Roche''), a research-based
pharmaceutical company. I am grateful for this opportunity to discuss
with you the roles of Roche and antiviral drugs in pandemic influenza
preparedness and response. I commend Congress, and specifically the
Chairman and Ranking Member of this Subcommittee, as well as the
Chairman of the full Senate Appropriations Committee, for making the
protection of the American people against avian influenza a priority
issue during the fiscal year 2006 appropriations process. We also
applaud the President, Secretary Leavitt, and the Department of Health
and Human Services (HHS) for the seriousness with which they have
approached this issue.
There are three key points that I would like to leave with you
today.
(1) Tamiflu is an effective antiviral medication for use in the
prevention and treatment of influenza, and it has been shown to have
activity against the H5N1 influenza strain. Experts agree that Tamiflu
and other antivirals are an essential part of any plan to help control
the spread of a pandemic flu virus and potentially reduce illness,
hospitalizations, and deaths during an influenza pandemic.
(2) Achieving rapid patient access to antivirals in the event of an
influenza pandemic will be critical; and
(3) Stockpiling antiviral drugs in advance of an influenza pandemic
is the only way to ensure that they are available when and where we
need them. Roche has been taking steps to prepare for a pandemic for
three years and is prepared to produce Tamiflu in sufficient
quantities so that the drug will be accessible to the American people
during a pandemic.
THE PANDEMIC INFLUENZA THREAT
Public health experts from around the world agree that we stand on
the precipice of a new influenza pandemic. Pandemic influenzas are
defined by three characteristics. First, little or no pre-existing
immunity to the strain exists in the human population. Second, the
strain causes illness in humans. Third, there is sustainable
transmission of the virus from person to person. The avian influenza
strain known as H5N1 currently satisfies the first two conditions, and
public health officials such as Dr. Julie Gerberding, Director of the
Centers for Disease Control and Prevention (CDC) and Dr. Lee Jong-Wook,
Director-General of the World Health Organization (WHO) have publicly
expressed grave concern that H5N1 could soon acquire the capability of
efficient transmission from person to person.\1\
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\1\ Pandemic Planning and Preparedness: Hearing Before the H.
Subcomm. on Health of the Comm. on Energy and Commerce, 109th Cong.
(2005) (statement of Julie L. Gerberding, M.D., M.P.H., Director, CDC);
Lee Jong-Wook, M.D., M.P.H., Director-General, World Health
Organization, Address at the Health Ministers Meeting on Global
Pandemic Influenza Readiness (Oct. 24, 2005) available online at http:/
/www.who.int/dg/lee/speeches/2005/influenza_readiness/en/index.html.
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Simply put, the threat of pandemic influenza is real. In the HHS
Pandemic Influenza Plan (HHS Plan), HHS notes that an influenza
pandemic ``has the potential to cause more death and illness than any
other public health threat.'' \2\ Last year, Secretary Michael Leavitt
testified before the House Committee on Government Reform that ``[i]f a
pandemic virus strain emerges, it is estimated that upwards of 30
percent of people exposed could become infected and the death rate will
likely be considerably higher than that seen with seasonal influenza.''
\3\ Studies cited recently by the CDC estimate that, without vaccines
or drugs, a ``medium level'' pandemic would kill between 89,000 and
207,000 Americans, and sicken another 20 to 47 million--causing up to
42 million outpatient visits and 734,000 hospitalizations.\4\
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\2\ Department of Health and Human Services, HHS Pandemic Influenza
Response and Preparedness Plan, Executive Summary 4, (Nov. 2004),
available at http://www.hhs.gov/pandemicflu/plan/pdf/Overview.pdf.
\3\ The HHS Pandemic Influenza Plan: Hearing Before the H Comm. on
Governmental Reform, 109th Cong. (2005) 2 (statement of Michael O.
Leavitt, Secretary, U.S. Department of Health and Human Services).
\4\ Centers for Disease Control and Prevention, Influenza Pandemic
Fact Sheet (Mar. 8, 2005), available at http://www.cdc.gov/flu/avian/
gen-info/pandemics.htm.
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The availability of adequate supplies of vaccines and antivirals is
recognized as an essential component of pandemic preparedness by both
the HHS Plan and the WHO Global Influenza Preparedness Plan.\5\
However, there is no approved vaccine currently available, and it will
likely take 3 to 6 months from the onset of a pandemic for an effective
vaccine to be developed, produced and distributed widely. Once
available, vaccines are expected to play a major role in bringing a
pandemic under control. In the interim between the emergence of a
pandemic strain and the development of a safe and effective vaccine,
and during the course of a pandemic, antivirals will be an essential
tool to treat influenza patients and limit the spread of the virus.
Recently published models suggest that an influenza pandemic could be
contained if 80 percent of those exposed to the virus used targeted
antiviral drugs prophylactically.\6\
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\5\ Department of Health and Human Services, HHS Pandemic Influenza
Response and Preparedness Plan, Executive Summary 4, (Nov. 2004),
available at http://www.hhs.gov/pandemicflu/plan/pdf/Overview.pdf;
World Health Organization, WHO Global Influenza Preparedness Plan 13
(2005), available at http://www.who.int/csr/resources/publications/
influenza/WHO_CDS_CSR_GIP_2005_5.pdf.
\6\ N.M. Ferguson et al., A Population-Dynamic Model for Evaluating
the Potential Spread of Drug-Resistant Influenza Virus Infections
During Community-Based Use of Antivirals, 51 Journal of Antimicrobial
Chemotherapy 977 (2003); I.M. Longini et al., Containing Pandemic
Influenza with Antiviral Agents, 159 Am. J. Epidemiology 623 (2004).
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TAMIFLU IS AN EFFECTIVE ANTIVIRAL MEDICATION
Tamiflu (oseltamivir phosphate), licensed from Gilead Sciences and
marketed globally by Roche, is the leading prescription oral antiviral
drug for influenza. First approved by the FDA in 1999 for the treatment
of adults with type A and B influenza, Tamiflu is a neuraminidase
inhibitor that directly attacks the influenza virus, compromising its
ability to replicate, rather than simply addressing influenza symptoms.
As of December 2005, Tamiflu is indicated for both treatment of
uncomplicated acute illness due to influenza infection in patients one
year and older who have been symptomatic for no more than 2 days and
prophylaxis of influenza in patients one year and older. Fortunately,
Tamiflu, which is available in both capsule and oral suspension form,
has a low likelihood of clinically significant drug interactions and is
generally well-tolerated, with nausea and vomiting being the most
frequently reported adverse events. To date, Tamiflu has been used by
about 33 million patients worldwide, 13 million of whom were children.
Tamiflu is available for the treatment of influenza in more than 80
countries.
At this time, Tamiflu is the only oral antiviral shown to be
active against the H5N1 avian influenza virus currently circulating in
Asia.\7\ Designed to be effective against influenza A and B types,
Tamiflu has shown activity against H5N1, a Type A influenza virus, in
the laboratory and in animals infected with the H5N1 strain taken from
humans. It was also reported that Tamiflu was used successfully in the
management of an outbreak of the H7N7 avian strain in the Netherlands
in 2003, which infected around one thousand people. Tamiflu was found
to protect infected poultry workers from contracting this strain, where
mouth and nose masks did not.
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\7\ See The Threat of and Planning for Pandemic Flu: Hearing Before
the Subcomm. on Health of the House Comm. on Energy & Commerce 109th
Cong. (May. 26, 2005) (Statement of Dr. Julie Gerberding). See also
M.D. de Jong et al., Oseltamivir Resistance during Treatment of
Influenza A (H5N1) Infection, 353 New Eng. J. Med. 2667 (2005) (The
benefit of oseltamivir antiviral treatment ``is suggested by the rapid
decline in the viral load to undetectable levels in all four survivors
in the current series.).
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Tamiflu works by blocking the action of the neuraminidase enzyme
on the surface of the virus. When neuraminidase is inhibited, the virus
is not able to spread to and infect other cells in the body. Consistent
with labeling, WHO recommends use of Tamiflu for treatment within 48
hours of symptom onset to reduce the duration of viral replication and
improve prospects of survival.\8\
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\8\ World Health Organization, Avian Influenza (``Bird Flu'') Fact
Sheet (Jan. 2006), available at http://www.who.int/csr/disease/
avian_influenza/avianinfluenza_factsheetJan2006/en/index.html.
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I would like to take this opportunity to address questions that the
Subcommittee may have related to recent news stories about resistance.
The potential exists for an influenza virus to emerge with decreased
sensitivity to any antiviral treatment, and Roche has both internal and
external mechanisms in place to monitor for emerging reports of
resistance. The vast majority of data collected from patients worldwide
who were treated with Tamiflu for seasonal influenza indicate that the
incidence of resistant virus is rare.
Even researchers, who recently reported on Tamiflu-resistant H5N1
strains in two Vietnamese patients who subsequently died,\9\
underscored that Tamiflu ``constitutes an important treatment option,
and stockpiling of this drug is part of pandemic-preparedness plans.''
\10\ Moreover, although resistant mutations of the H5N1 virus were
detectable in these patients at the end of treatment with Tamiflu, the
viral mutation isolated in those patients is known to be less
transmissible than the wild-type virus present in other subtypes of
influenza viruses.
---------------------------------------------------------------------------
\9\ M.D. de Jong et al., Oseltamivir Resistance during Treatment of
Influenza A (H5N1) Infection, 353 New Eng. J. Med. 2667 (2005).
\10\ Id.
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Human clinical trials have not yet been conducted with the H5N1
avian flu strain, and it is important that different treatment regimens
be explored, including the possibilities of using a higher dose and/or
a longer treatment duration. To that end, Roche is now collaborating
with the National Institutes of Health (NIH) and WHO, who are
undertaking clinical research to assess the efficacy of a higher dose
of Tamiflu in the treatment of severe influenza, including the H5N1
virus.
According to the Neuraminidase Inhibitor Susceptibility Network
(NISN), the clinical and epidemiological implications of possible
antiviral resistance in future pandemic influenza viruses are
incompletely understood. However, neuraminidase inhibitors such as
Tamiflu should be effective for both prevention and treatment for such
viruses, and concerns about antiviral resistance, particularly to
neuraminidase inhibitors, should not dissuade countries from developing
adequate antiviral stockpiles for pandemic response.\11\
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\11\ NISN Statement on antiviral resistance in influenza viruses.
Weekly Epidemiological Record (2004); 33, 308-308.
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THE ROLE OF TAMIFLU IN AN INFLUENZA PANDEMIC
There are two ways Tamiflu can be used in a pandemic setting.
First, in infected patients, Tamiflu begins working immediately and is
active against multiple influenza types. Patients can still mount an
immune response to the virus while taking Tamiflu, which reduces
duration and severity of symptoms when administered within 48 hours of
symptom onset. Second, Tamiflu can be used preventatively to help
those exposed to the virus from becoming infected. When administered
within 48 hours of exposure, clinical data demonstrate Tamiflu is
highly effective at preventing seasonal flu, a characteristic which, if
replicable with a pandemic strain, would be key to controlling the
spread in households, the workplace and healthcare settings.
Overall, experts agree that Tamiflu is uniquely suited to pandemic
stockpiling for several reasons: (1) Tamiflu-resistant viruses appear
rare and generally are not readily transmissible in humans; (2) the
product has a five-year shelf life, and (3) unlike other antivirals,
Tamiflu is active throughout the entire body. This could be clinically
important, as some of the reported H5N1 human cases have documented
illness in the lungs, digestive tracts, mouths, and noses of
victims.\12\
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\12\ World Health Organization, Avian Influenza (``Bird Flu'') Fact
Sheet (Jan. 2006), available at http://www.who.int/csr/disease/
avian_influenza/avianinfluenza_factsheetJan2006/en/index.html.
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ROCHE HAS EXPANDED ITS CAPACITY TO RESPOND TO PANDEMIC PLANNING
WORLDWIDE
Historically, Roche has produced enough Tamiflu to meet the
seasonal influenza demand, and we have marketed the product responsibly
to avoid undermining public health messaging regarding seasonal
vaccinations. U.S. prescriptions for Tamiflu capsules have risen from
roughly 700,000 in the 1999-2000 flu season to over 1.7 million in the
2004-2005 flu season. In contrast, the HHS Plan calls for the
stockpiling of at least 81 million antiviral treatment courses, which
is sufficient to cover 25 percent of the U.S. population.\13\ To reach
this goal, it is imperative that Tamiflu be stockpiled and pre-
positioned in advance of the outbreak of a pandemic. Surge
manufacturing in the event of a pandemic is not an option. The
manufacturing process for Tamiflu requires a number of months to go
from raw materials to finished product, and significant lead time is
needed to build stockpiles at the magnitude called for in the HHS Plan.
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\13\ U.S. Department of Health and Human Services, HHS Pandemic
Influenza Plan, Part 1_Strategic Plan 24 (2005).
---------------------------------------------------------------------------
As early as 2003, before we had received any firm governmental
commitments, Roche recognized that responding to pandemic influenza
would require enormous additional capacity. Since 2003, we have doubled
our production capacity each year. By the end of the third quarter of
2006, we will be able to produce over 300 million treatments of
Tamiflu annually. We have reached this potential in part by adding
capacity to meet specific production challenges. Roche recently granted
sub-licenses for Tamiflu production to two companies, one in India and
one in China, for production for less-developed nations, and we
continue active discussions with a dozen potential sub-contractors as
part of our ongoing United States efforts to expedite production. This
process has included an extensive evaluation of the technical
capabilities of potential sub-contractors. Currently, the Global
Tamiflu Supply Network includes approximately 50 external suppliers
and 7 external manufacturers.
We have now received and are on schedule to fulfill Tamiflu
stockpile orders from almost 65 countries. We are also particularly
proud that we have been able to donate 5 million Tamiflu treatment
courses to WHO, three million treatments for their mobile rapid
response stockpile and two million treatments for use against avian
influenza outbreaks in developing nations.
We are also committed to expanding and enhancing our U.S.
production processes. During discussions with HHS, which first began 3
years ago, HHS made three requests regarding U.S. production of
Tamiflu. Roche has fulfilled them all.
(1) Roche created a U.S. supply chain for Tamiflu production,
which is now operational, producing 15 million treatments per year. By
the end of the third quarter of 2006, that chain will be capable of
producing about 80 million treatments annually.
(2) Roche has developed special U.S. pandemic packaging for
stockpiling Tamiflu to ease distribution and administration; and
(3) Roche is providing Tamiflu to Federal and State governments at
a reduced pandemic stockpiling price.
Based on subsequent conversations with HHS, we are also bringing to
the United States the ability to produce a synthetic form of the
initial starting material for Tamiflu, Shikimic Acid, reducing our
reliance on scarce natural sources.
With respect to the U.S. stockpile, Roche has filled all U.S.
Government pandemic stockpiling orders to date, which total
approximately 5 million courses of therapy, less than 2 percent of the
U.S. population. Until last week, we were working under a letter of
intent from the government seeking an additional 15 million treatments
to be delivered in fiscal year 2006. On Friday, we received a revised
projection from HHS indicating that fiscal year 2006 stockpile
purchases may total up to 46 million courses of treatment. According to
that letter, 18 million of that total would be purchased directly by
HHS, and 28 million would be dependent upon purchase decisions made by
individual States. Additional purchases are planned for fiscal year
2007 and 2008.
We are ready to begin filling these orders as soon as we receive a
final contract, which we anticipate shortly. Thereafter, Roche is
committed to ensuring that we can provide the full stockpile
recommended to cover 25 percent of the U.S. population as outlined in
the HHS Plan. However, given global demand, the U.S. Government must
have the resources required to make an immediate and sustained
contractual commitment for that full stockpile.
We are also meeting the seasonal influenza need for Tamiflu.
Recently, Roche lifted all restrictions on the distribution of Tamiflu
for seasonal orders and is now shipping product to all U.S. markets as
part of its proactive inventory management plan. Roche had previously
been distributing Tamiflu only to U.S. cities where high incidence of
influenza was being reported, based on the FluSTAR Surveillance System.
This plan was implemented last fall following a huge spike in Tamiflu
demand, caused in part by fears of a potential flu pandemic. The
decision to open distribution was based on recent developments,
including increased flu reports from around the country and a Health
Alert issued by the CDC recommending against the use of two other
antiviral medications, amantadine and rimantadine, for the remainder of
the 2005-2006 season, due to high levels of resistance.
FULL FUNDING OF THE PRESIDENT'S NATIONAL STRATEGY ON PANDEMIC INFLUENZA
IS ESSENTIAL
The HHS Plan is a broad-based strategic document, which identifies
the critical needs the United States must address to prepare adequately
for the emergence of an influenza pandemic.\14\ We applaud the HHS
Plan's call for critical investments not only to improve domestic
vaccine capacity and ensure sufficient antiviral supplies, but also to
enhance national and international disease surveillance, and to develop
appropriate Federal, State, and local response plans.\15\ If integrated
into a strong pandemic preparedness and response plan, such as is
outlined in the HHS Plan, Tamiflu--particularly in the early stages in
a pandemic when a vaccine may not be available--can play a primary role
in treating and preventing infections. During a pandemic, there will be
heightened awareness of influenza and--with the type of functioning
infrastructure and appropriate pre-positioning called for in the HHS
Plan--we believe rapid response can be achieved.
---------------------------------------------------------------------------
\14\ U.S. Department of Health and Human Services, HHS Pandemic
Influenza Plan, Executive Summary (2005). See also The HHS Pandemic
Influenza Plan: Hearing Before the H Comm. on Governmental Reform,
109th Cong. (2005) (statement of Michael O. Leavitt, Secretary, U.S.
Department of Health and Human Services).
\15\ See U.S. Department of Health and Human Services, HHS Pandemic
Influenza Plan, Executive Summary (2005).
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We are appreciative of the substantial funding provided to date for
the HHS Plan. However, it is absolutely essential that all parts of the
HHS Plan be funded in full without delay. Piecemeal appropriations will
only add an additional hurdle for pandemic planners to overcome. The
currently circulating potential pandemic virus is a formidable foe, yet
global public health surveillance has given us the rare benefit of a
warning of what is likely to come. Today is our chance to invest in the
future health of this Nation by implementing sound measures that will
improve our overall public health responsiveness and help protect us
from pandemic influenza. Based on our expansion to date, Roche is
currently in a position to accommodate a U.S. stockpile order that
would satisfy the coverage goals of 81 million treatment courses
outlined in the HHS Plan. To fulfill such an order, however, requires
an immediate and sustained commitment from the U.S. Government.
We at Roche want to continue to work closely with this
Subcommittee, HHS, and governments around the world to assist in
ensuring our pandemic preparedness. I can assure you that this effort
is our highest priority. On behalf of Roche, thank you for highlighting
the importance of this critical public health issue.
I am pleased to answer any questions you may have.
Hoffmann-La Roche Inc.,
Nutley, NJ, February 7, 2006.
Senator Arlen Specter, Chairman,
Senator Tom Harkin, Ranking Member,
Subcommittee on Labor, Health and Human Services, Education, Related
Agencies, Senate Committee on Appropriations, Washington, DC.
Dear Chairman Specter and Senator Harkin: Thank you for the
opportunity to appear before your Subcommittee earlier this week to
offer testimony and answer questions regarding the roles of Hoffmann-La
Roche Inc. (Roche), and antivirals in pandemic influenza preparedness
and response. We applaud your efforts to raise awareness about the
urgent need for pandemic planning, and your leadership in ensuring that
the U.S. Government has the necessary resources to protect our Nation
from this looming threat.
As requested, we are pleased to answer the questions you posed
prior to the conclusion of the hearing. Below please find a restatement
of each question followed by Roche's response.
Question. Please provide more detail regarding the most recent
letter of intent to purchase Tamiflu for U.S. pandemic stockpiles that
Roche has received from the Department of Health and Human Services
(HHS). Specifically, please discuss what level of contractual authority
Roche requires to begin acting on this order.
Answer. The most recent HHS letter of intent, dated January 27,
2006, projects procurement of Tamiflu for the pandemic stockpile as
follows:
The amount that HHS intends to purchase or order on behalf of State
governments in fiscal year 2006 has been revised to up to forty-six
(46) million courses, including amounts subject to pending discussions
with State governments. HHS intends to purchase additional amounts in
fiscal year 2007 and fiscal year 2008.
Current planning for these fiscal year 2006 purchases envisions
eighteen (18) million courses to be purchased by HHS and an arrangement
with State governments where HHS would subsidize State purchases of
twenty-eight (28) million courses. The amount of State purchases is
dependent on purchase decisions made by individual States.
While we fully appreciate the importance of this expression of
intent, the letter specifically States that these purchase levels are
both subject to change and contingent upon the availability of funding.
Since Roche faces enormous demand for Tamiflu from governments around
the world, we cannot indefinitely reserve capacity on the basis of a
non-binding letter of intent. To ensure that sufficient production
capacity is reserved to meet the stockpiling goals of the HHS Pandemic
Plan as rapidly as possible, it is essential that HHS proceed to
finalize a binding contract with Roche for the maximum level of
procurement permitted under current appropriations. Moreover, to ensure
that HHS can enter into firm contractual commitments for the remainder
of the required U.S. stockpile, it is critical that Congress
appropriate the remaining funds required for stockpile purchases as
soon as possible in 2006.
Question. Please comment on the proposed liability protections
discussed during the hearing. Please indicate whether Roche believes
the current provision is adequate and/or realistic; what obstacles, if
any, Roche foresees; and any additional information that would be
relevant given Roche's expertise in this area.
Answer. We believe the protections contemplated under the recently
enacted Public Readiness and Emergency Preparedness Act of 2005
framework (Public Law 109-148) should address our significant concerns
regarding the liability implications of the provision of Tamiflu for
the pandemic stockpile. Given the likely scenarios for pandemic use of
Tamiflu, including an unprecedented patient population, dosing at
levels and for durations significantly in excess of labeling, and use
under greatly reduced physician supervision, liability protections for
pandemic use of Tamiflu are reasonable and necessary. Thus, in
addition to other contractual protections, we will be asking the
Secretary of HHS to include Tamiflu in any declaration triggering
liability protections for pandemic countermeasure products. The
protections under any such declaration should be comprehensive, and
equivalent to those afforded to pandemic influenza vaccines.
Question. Please provide Roche's assessment of S. 2112, which would
establish programs and activities to increase influenza vaccination
rates through the provision of free vaccines.
Answer. Roche does not manufacture vaccines, and thus we defer to
vaccine manufacturers' assessment of such legislation. However, please
note that Roche strongly supports efforts to increase seasonal
influenza vaccination levels, and we have consistently sought to ensure
that the marketing of Tamiflu is complementary to public health
messages regarding the role of vaccines. We also note that, even with
greatly enhanced vaccination levels, increasing the seasonal use of
antivirals would be beneficial in preventing and treating infections.
Roche is committed to working closely with your Subcommittee, HHS,
and governments around the world to assist in pandemic preparedness. If
you have further questions, please do not hesitate to contact me.
Respectfully submitted,
George B. Abercrombie,
President and Chief Executive Officer.
Senator Specter. We'll turn now to Mr. Daniel Soland,
president of the Vaccines of Chiron Corporation. Bachelor of
Science and Pharmacy from the University of Iowa. We have
another 2 minute allocation, the floor is yours Mr. Soland.
STATEMENT OF DANIEL SOLAND, PRESIDENT OF VACCINES,
CHIRON CORPORATION
Mr. Soland. Thank you for the opportunity to appear before
the committee, I will summarize three key points from my
written statement. From Chiron's perspective as a vaccine
manufacturer, we believe that there are three critical assets
required for the United States to effectively prepare for
pandemic influenza: one, technology and innovation; two,
development capability to turn technology into effective
products; and three, the capital investment to deliver new
technologies in the shortest time possible.
My first point, technology and innovation: I think we all
understand that vaccine research and development against new
and deadly vaccines, is a long and very difficult process that
requires sustained investment. Chiron initiated innovative
research on avian influenza concerns back in 1997, after the
H5NI outbreak in Hong Kong first infected humans. These studies
reported in peer reviewed journals Lancet, Vaccine, and Journal
of Infectious Disease, between 2001 and 2005 concluded that the
use of Chiron's adjuvant a novel adjuvant, MF59 in an avian flu
vaccine may allow dose-sparing, where using less vaccine
adjuvant per person would allow more people to be immunized,
and secondly to offer cross-protection, where the vaccine may
offer protection against an avian virus even after it has
changed or drifted over time.
This past October, Chiron reported promising data from an
H9N2 another avian strain study which found that the vaccine
formulations containing MF59 were highly used in the clinical
trial were highly immunogenic, even at the lowest dose of 3.75
micrograms of antigen this is a quarter of the normal dose in
seasonal flu vaccine. At the present time, we are in
collaboration with the National Institute of Allergy and
Infectious Diseases to evaluate the use of this adjuvant in a
trial with H5NI.
Which brings me to the second point and that's development
capability: Chiron is on track to deliver new technologies into
innovative products with our adjuvanted vaccines which we just
discussed. Our second-generation influenza manufacturing
technology. Flu cell culture. Flu cell culture is an important
technology for securing annual vaccine production and also for
long-term pandemic preparedness. When approved by regulatory
authorities it will provide significant advantages and
flexibility over traditional manufacturing methods by
eliminating the dependence on chicken eggs. Remember if we
don't have chickens, we don't have eggs, we don't have----
Senator Specter. Mr. Soland, could you summarize at this
point, please.
PREPARED STATEMENT
Mr. Soland. Sure. In my third and final point, I appreciate
the uncertainties that Congress has faced with the question of
if and when and relative to the global pandemic, juxtaposed
against the need to act in a physically responsible way in
tight economic times. However there is a sense of urgency
growing everyday relative to pandemic influenza and the
Government must engage in public private partnerships with all
vaccine manufacturers to effectively prepare for the global
pandemic. Thank you.
Senator Specter. Thank you very much Mr. Soland.
[The statement follows:]
Prepared Statement of Dr. Dan Soland
Mr. Chairman, Members of the Committee: Thank you for the
opportunity to provide a statement to the Appropriations Committee to
address the critical importance of funding for pandemic preparedness. I
am Dan Soland, President of Chiron Vaccines, one of the three divisions
of Chiron Corporation, a U.S. biotechnology company headquartered in
Emeryville, California. Chiron Corporations two other businesses are:
BioPharmaceuticals and Blood Testing.
CHIRON OVERVIEW
Chiron Vaccines is committed to the development and supply of
vaccines to protect society against a range of important diseases,
notably the possibility of a global influenza pandemic. We, and our
predecessor companies, have a 100-year history in vaccine development
and are the world's fifth-largest vaccines business with facilities
located throughout Europe and Asia. Chiron Vaccines is the world's
second-largest manufacturer of influenza vaccines and has important
meningococcal, pediatric and travel vaccine franchises. We are the
leading vaccine manufacturer in the United Kingdom, Germany and Italy.
The company's portfolio of products includes vaccines for influenza,
meningococcus C, rabies, tick-borne encephalitis. haemophilus
influenzae B (Hib), polio, mumps, measles and rubella (MMR) and
diphtheria, tetanus and pertussis (whooping cough).
CHIRON AND PANDEMIC INFLUENZA
I welcome the opportunity to discuss with you the uncertain
environment that the very real threat of a global influenza pandemic
creates, and the importance of stabilizing our public health capacity
and manufacturing infrastructure through public-private partnerships to
save the lives of millions of Americans,
From Chiron's perspective as a manufacturer, we believe that there
are three critical assets required for the United States to effectively
prepare for pandemic influenza: technology and innovation, the
development capability to turn technology into effective products and
the capital investment to deliver new technologies in the shortest time
possible.
Technology and Innovation.--Vaccine development against new and
deadly viruses is a long and laborious process. The erosion of our
domestic vaccine manufacturing capacity over the past decade has placed
us in a precarious position relative to protecting public health, The
most recent avian influenza concerns first arose 9 years ago, in 1997,
when the H5N1 avian influenza virus moved from birds into humans. The
evolution of this virus during the past 9 years and its emergence
outside of the Pacific Rim countries in the past several months has
heightened concern about our preparedness to deal with a global
influenza pandemic.
Chiron initiated innovative research on avian flu after the H5N1
outbreak in Hong Kong first affected humans. The high mortality of the
H5N1 virus among birds, the quality that made it such a concern, also
made it problematic to use in vaccine development--the virus tended to
kill the chicken eggs that served as the first step of the vaccine
production process. Chiron instead worked with a less pathogenic strain
of H5 and consequently developed an H5N3 virus vaccine for testing
against the H5N1 virus strain. Studies of this vaccine included
Chiron's proprietary adjuvant, MF59. An adjuvant is a substance that is
added to a vaccine to enhance the body's immune response to the
vaccine's active constituent, called the antigen. Our research found
that, without the adjuvant, various tested doses of vaccine did not
induce protective levels of antibodies. With the adjuvant, however, the
vaccine induced protective antibody levels against the original H5N1
strain. Even at dose levels of 7.5 micrograms--half the dose of the
seasonal influenza vaccine-protective levels were achieved.
Importantly, people immunized with the adjuvanted vaccine in this trial
showed protective antibody tilers not--just against the original H5N1
strain, but also against drifted strains of H5N1 that had changed over
time.
These studies, reported in the peer-reviewed journals Lancet,
Vaccine and the Journal of Infectious Diseases between 2001 and 2005,
concluded that the use of Chiron's adjuvant MF59 in an avian flu
vaccine may:
--allow dose-sparing, in which using less vaccine per person would
allow more people to be immunized, and
--offer cross-protection, in which the vaccine may offer protection
against an avian flu virus even as it changed over time.
These findings must be validated by additional research. We were
pleased with the validating research recently announced as a result of
our collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID). In October 2005, Chiron reported promising data from
an H9N2 study which found that all vaccine formulations containing MF59
were highly immunogenic, even at the lowest dose of 3.75 micrograms (a
quarter of the dose used in seasonal flu vaccines). At the present
time, we are collaborating with the NIAID to evaluate the use of this
adjuvant in a trial of our H5SN1 vaccine.
What is the lesson from Chiron's multi-year investment in pandemic
vaccine research? Establishing the framework for the development of a
pandemic vaccine is a long-term process that requires funding
stability. Further, it is critically important the industry have the
development capability to translate research into effective products.
Development Capability.--Chiron has pushed the frontiers of science
with the development of second-generation technologies for influenza
vaccines. We believe we are on track to turn new technologies into
innovative products with our adjuvanted vaccines and our second-
generation influenza technology, Flu Cell Culture (FCC).
I have already addressed our track record in innovation for
adjuvanted vaccines relative to pandemic influenza. Chiron has an
adjuvanted vaccine. Fluad, which has been approved and on the market in
several European countries for seasonal influenza for almost a decade.
Experience with the use of this product in millions of Europeans
positions us to apply our knowledge with adjuvanted vaccines to
pandemic influenza development.
Additional technologies and innovation, such as FCC, are also
critical to stabilize manufacturing capacity and rapidly respond to a
global influenza pandemic. FCC vaccines represent the next generation
of influenza vaccine production, both for annual vaccines and for long-
tern pandemic preparedness. FCC can provide significant advantages over
traditional manufacturing methods by eliminating the dependence on
chicken eggs for production. Removing egg supply lead times would
enable flexible and faster start-up of vaccine production in the event
of an annual vaccine supply shortfall or an avian influenza pandemic.
Chiron has completed its second pivotal phase III enrollment in
Europe for our FCC vaccine and plans to submit for E.U. regulator
approval in 2006. Chiron has a validated, full scale manufacturing
facility for FCC in Marburg, Germany that is presently undergoing
expansion in preparation for our launch in the E.U. This fall we
initiated our FCC development program in the United States with the
launch of our Phase I/II research program. We are engaged with the U.S.
regulatory authority, the Food and Drug Administration (FDA) and its
advisory bodies, to structure the pathway for development and
regulatory approval in the United States.
Translating innovative technology into products on the market is
not possible without a strong and well-resourced FDA. Over the past
year, Chiron has had the opportunity to work closely with the men and
women of the FDA as we proceeded through the remediation of our
Liverpool facility. The FDA is to be commended for its professionalism,
dedication and commitment to the vaccine industry. Having observed
their dedication, it is regrettable that the funding for FDA under the
recently enacted pandemic influenza supplemental appropriation is so
limited. This agency will be pivotal in assuring that manufacturers can
translate innovation into effective products and it is in the best
interest of the United States that the FDA be appropriately funded to
meet this important challenge. Mr. Chairman, Members of the Committee,
this is one critical area where the government needs to provide
additional resources to the FDA so they can carry out their mandate
relative to pandemic preparedness.
The close collaboration of the FDA with European regulatory
authorities enabled Chiron to supply influenza vaccine this season. In
addition, HHS announced this past fall the award of a contract to
Chiron for the production of pandemic influenza vaccine for the
government's stockpile, which will be a critical source of vaccine
supply in the early days of a pandemic. Production of the pandemic
stockpile vaccine is underway now.
Capital Investment.--The growing concern with regard to the
inevitability of a global influenza pandemic, coupled with the erosion
of our public health and manufacturing infrastructure in the United
States, creates a precarious situation as we develop the technologies,
tools and policies to deal with pandemic influenza. We are engaged in a
monumental undertaking that may save the lives of millions of
Americans. It is critically important that the capital investment be
available to deliver innovative technologies to the U.S. market in the
shortest time possible. I should add that meeting the technical
challenges required to prepare for a possible pandemic influenza
outbreak entails significant business risks for manufacturers such as
Chiron, Even with the support of the government, Chiron will be obliged
to make a significant investment of time and money before it is able to
realize any return on that investment. And there is no guarantee that
Chiron will recover its costs or turn a profit on that investment.
The political resolve and will to create an environment of
certainty for vaccine manufacturers is crucial to create U.S. vaccine
manufacturing capacity and enable it to flourish, I appreciate the
uncertainties that Congress faces associated with the ``it'' and
``when'' questions relative to a global pandemic juxtaposed against the
need to be fiscally responsible in tight economic times. However, we
must have a sense of urgency--the U.S. vaccine capacity and our public
health infrastructure has been eroded over several decades and they
will not be restored in days, weeks or months. These assets will take
years to rebuild.
Chiron Corporation strongly supported the administration's funding
request for pandemic influenza of $7.1 billion transmitted to Congress
in November 2005. The administration's request was structured to
provide the Department of Health and Human Services (HHS) with the
flexibility and resources to make the critical decisions about resource
allocation to minimize the human and economic toll of pandemic
influenza. Priorities that require full funding include:
--Improving our health care system capacity to identify and care for
infected individuals;
--Global and national surveillance in order to allocate scare
resources efficiently;
--International responsibilities to aid nations where H5N1 is
endemic;
--Stockpiling to protect U.S. citizens; and
--The substantial challenge of restoring our vaccine industry in the
United States.
We appreciate that Congress provided a significant down payment on
the administration's request for HHS this past December as part of the
Department of Defense Appropriations bill; however, the resources
provided to HHS fell $3.4 billion short of the administration's
request. This shortfall did not send a positive message to
manufacturers about the certainty and stability of the government
efforts to fully address a public health threat of this magnitude. The
message of certainty and stability for the U.S. vaccine manufacturing
industry needs to be clear and unequivocal in light of its erosion in
past years.
The administration needs to include the remaining $53.4 billion for
HHS in their fiscal year 2007 funding proposal and Congress must find
the resolve to fully resource this program. These funds are vitally
important for competitive research programs: resources to fund the FDA
and HHS's pivotal role in vaccine development and facility validation;
and establishing and expanding domestic manufacturing capacity of
second generation technologies, among other important priorities, so
that pandemic preparations can be effectively resourced.
The government must engage in numerous public-private partnerships
to maximize U.S. investment. Preparing for a global pandemic requires
the consistent, committed and full collaboration of all vaccine
manufacturers. A December 2005 report issued by the General Accounting
Office (GAO) cites the potential for substantial economic impact as a
result of a global pandemic. In its analysis, the GAO developed two
models to estimate economic impact: severe and mild. The modeling for a
severe pandemic indicates that the estimated decrease in ``real GDP''
of 4.7 percent exceeds the impact of every post WWII recession except
the one following 1981. In the event of a mild global pandemic, the
impact on GDP will be significantly less; however, GAO has estimated
that economic growth will slow.
We cannot afford to partially fund an effort of this magnitude--the
human and economic consequences of inadequately preparing will be too
grave. Of the three assets I described at the outset of my statement--
technology and innovation; development capability; and capital
investment--two are fully in place but the third, capital investment,
is not fully present. Chiron stands ready to commit its scientific
expertise, innovation and resources in collaboration with the
government to engage in effective public-private partnership to ensure
that the resources are available and the United States is positioned to
meet this global challenge.
CONCLUSION
In closing, let me thank Congress for enacting legislation last
year to address the critically important issue of pandemic influenza
vaccine liability. We are grateful for the leadership of Congress and
the administration in addressing this issue. Pandemic vaccine products
present unknown risks. Whatever regulator approval mechanism might be
adopted for pandemic vaccine in the event of an avian flu outbreak, it
is likely that testing of the pandemic vaccine in humans will be less
extensive than that for traditional flu vaccines. As a result, there
may be limited data available on safety and adverse events before the
vaccine is put into use. Additionally, it may be difficult to predict
the numbers of people who would receive the pandemic vaccine--in the
event of a pandemic, the number could be far greater than the number
currently vaccinated with the trivalent product, and could include
subpopulations that would not normally be considered at high risk. For
these reasons, and plan to prevent or treat pandemic influenza has the
potential to present major liability risks to manufacturers and health
care professionals. Products must be developed on an emergency basis
and administered in a very short period of time to tens or hundreds of
millions of people. The liability plan adopted by Congress was a
critical first step in establishing a comprehensive liability program
for pandemic influenza and Chiron looks forward to working with
Congress to craft a compensation program to protect the interests of
individuals who are immunized when a pandemic situation exists.
Mr. Chairman, this concludes my formal remarks and I will be happy
to answer any questions you or the Committee might have for me. Thank
you.
Senator Specter. Our next witness is Dr. Chris Viehbacher,
president of U.S. Pharmaceuticals GlaxoSmithKline (GSK).
Graduate of Queens University Ontario, with a degree in
commerce. Thank you for joining us Mr. Viehbacher and the floor
is yours for 2 minutes.
STATEMENT OF DR. CHRISTOPHER VIEHBACHER, PRESIDENT OF
U.S. PHARMACEUTICALS, GLAXOSMITHKLINE
Dr. Viehbacher. Thank you Mr. Chairman, Senator Harkin,
Senator Stevens. GlaxoSmithKline is unique as a manufacturer of
both seasonal and pandemic flu vaccine, as well as the licensed
antiviral Relenza. Now in 2005 alone, GSK committed over $2
billion to strengthen the long-term commitment we have made to
the U.S. flu market and to position GSK to help respond
effectively to a pandemic. As a result of those investments
we'll be able to manufacture more than 150 million doses per
year of seasonal flu vaccine by 2008, and about half of that
will be based here in North America.
We will significantly expand U.S. manufacturing capacity
for Relenza and clinical trials are due to start soon on two
candidate H5N1 vaccines that use antigen-sparing techniques
that may allow us to stretch the supply of vaccine. Our Seattle
operations add to GSK's leadership in using novel adjuvants to
improve vaccines. Thanks to your help Senator Specter we'll be
able to base our cell technology at our newly acquired site in
Marietta, Pennsylvania.
PREPARED STATEMENT
The threat of a pandemic cannot be met successfully without
a robust private-public partnership. Our pandemic investments
would not have been made without the financial investments from
the Federal Government. I know that the administration and
Congress appreciate these realities. We support the
administration's estimate of what is required to fully respond
to the country's pandemic needs. Funding would be most
effective if it is provided in multi-year commitments. We're
making large investments to do our part to assist in
preparedness, and we need to be able to plan around the
Government's role and ability to partner with us. Thank you for
the opportunity to appear before you today, I would be happy to
answer any questions you might have.
Senator Specter. Thank you very much, Mr. Viehbacher.
[The statement follows:]
Prepared Statement of Dr. Christopher Viehbacher
Mr. Chairman and members of the Committee, I am pleased to be here
today to describe GSK's efforts, working with our partners in
government, to help prepare for the next influenza pandemic. My name is
Chris Viehbacher and I am the President of U.S. Pharmaceuticals at
GlaxoSmithKline. I appreciate the opportunity to appear before the
Subcommittee today and look forward to answering your questions.
As a leading global provider of vaccines and anti-viral
medications, GSK stands ready to support governments, health
authorities and our own employees around the world in planning to
respond to a global influenza pandemic. We had the opportunity, with
our other industry colleagues, to meet with President Bush on this
subject last year and applaud his recognition of the integral role
industry can play in preparing for a pandemic. At that meeting, and in
earlier discussions with the Secretary of Health and Human Services,
GSK expressed its commitment to being part of the collective effort
needed to develop an effective global response to flu pandemic. During
this interpandemic period, GSK is committed to developing products to
respond to the threat. Should a flu pandemic occur, GSK would work with
governments and health authorities to ensure the availability and
appropriate distribution of vaccine and antiviral supplies.
As the only manufacturer of both candidate pandemic vaccines and a
licensed antiviral that could be effective in an influenza pandemic,
GSK has taken significant steps to prepare for a pandemic. We have
committed over $2 billion in 2005 to expand our flu vaccine
manufacturing capacity and increase production of the antiviral
Relenza. This includes doubling vaccine manufacturing capacity at our
Dresden, Germany site, acquiring Canadian vaccine maker ID Biomedical,
acquiring a 90 acre vaccine research and development and manufacturing
site in Pennsylvania, and expanding manufacturing capacity for Relenza,
including adding capacity at our North Carolina facility.
VACCINES
In 2005 we made great progress in increasing our capacity for
manufacturing of influenza vaccines and developing potential pandemic
vaccines, strengthening the long-term commitment we have made to the
U.S. influenza market and positioning GSK to be able to respond
effectively in the event of a future influenza pandemic.
GSK manufactures Fluarix, an inactivated trivalent vaccine for
seasonal influenza, prepared in eggs, which was approved for use in
adults by the FDA in 2005, and is also marketed in 79 other countries.
Fluarix is manufactured in Dresden, Germany. In June 2005, GSK
announced plans to double the capacity of the Dresden facility from
today's 35 million doses to 60-80 million doses by 2008.
In December 2005, GSK acquired ID Biomedical, an integrated
biotechnology company that manufactures another egg-based, inactivated,
trivalent seasonal flu vaccine, Fluviral, currently marketed in Canada.
GSK plans to seek FDA approval for this seasonal influenza vaccine in
2006 in preparation for the 2006/2007 seasonal influenza season. ID
Biomedical is in the process of expanding its flu vaccine manufacturing
facilities in Quebec province, Canada, which are expected to produce
around 75 million doses beginning in 2007.
In the event of a pandemic, existing facilities engaged in the
manufacturing of seasonal flu vaccine would be the first and easiest
facilities to convert to production of a vaccine against the pandemic
virus. All combined, by 2008, GSK anticipates having capacity to
manufacture more than 150 million doses per year of egg-based trivalent
inactivated influenza vaccine.
GSK is also aggressively developing candidate pandemic influenza
vaccines. We have previously demonstrated the feasibility of using an
antigen-sparing pandemic vaccine composition based on clinical trial
data generated with two influenza A sub-types having pandemic
potential. The first is H2N2 virus, a human influenza strain which
caused the 1957 pandemic, and the second is H9N2 virus, an avian
influenza strain implicated in several clusters of bird-to-human
transmission with resulting mild illness in Southern China in 1998-
1999. The basis for the vaccine's antigen-sparing property is inclusion
of aluminum salt as an adjuvant. The company is planning clinical
trials of a pandemic vaccine candidate made with the H5N1 strain and
aluminum salts in the first quarter of 2006. Because GSK has developed
another novel adjuvant system with potentially greater
immunostimulatory properties than aluminum salts, a second H5N1
pandemic vaccine candidate with the novel adjuvant system has been
manufactured and will be used in a clinical trial due to start soon.
These antigen-sparing pandemic vaccine candidates may allow us to
stretch the supply of vaccine, by requiring lower amounts of antigen.
We are also working to ensure that necessary regulatory files are
in place prior to a pandemic. GSK submitted a ``mock-up'' dossier for
the H5N1 flu pandemic vaccine composition to the European Agency for
the Evaluation of Medicinal Products (EMEA, the European version of the
FDA) in late December. The approval of this dossier in advance of a flu
pandemic declaration by the World Health Organization will hasten
licensing of a pandemic vaccine once a pandemic influenza strain is
identified.
Lastly, we are investing in new vaccine production technologies,
highlighted in the 2005 acquisition of two key domestic holdings. The
first is a Seattle-based company called Corixa that specializes in
developing novel adjuvants to boost the body's immune response to a
vaccine; additional novel adjuvants from this organization may allow a
new generation of pandemic influenza candidates to be prepared and
evaluated. The second is a 90-acre vaccine research, development and
manufacturing facility in Marietta, Pennsylvania, where we plan to base
our work in cell culture flu vaccine. With additional Federal
collaboration through competitive contracts, we hope to rapidly advance
this new technology to supplement and eventually move away from the use
of eggs in flu vaccine manufacturing. I would like to thank both
Senator Specter and Governor Rendell for their valuable support in
making the Marietta facility acquisition possible.
ANTIVIRALS
I mentioned that we also produce an antiviral called Relenza.
Relenza is an inhaled medicine delivered through a device called a
Diskhaler to the surface cells of the upper respiratory tract. Relenza
is a prescription medicine for the treatment of influenza A and B virus
infections. In many countries around the world, Relenza is also
approved for use to prevent seasonal flu. Last November, we filed with
the FDA to expand Relenza's indication to include prophylaxis in the
United States. Relenza has not been studied in patients who have H5N1
avian flu. However, there is laboratory data indicating that Relenza
added to cultured cells inoculated with influenza virus, including the
H5N1 avian flu sub-type, inhibits virus growth. Moreover, Relenza
protects animals from illness when they are challenged with highly
pathogenic H5N1 virus. Based on these data, experts believe that
Relenza will be effective in treating influenza illness during a
pandemic.
Our current supplies of Relenza are very limited, as orders are
well in excess of historical demand for the product. GSK is investing
heavily to increase its Relenza manufacturing capacity so we can expand
supplies significantly in the future, including expanded domestic
capacity at our plant in North Carolina. However, even with this
investment, near-term demand is still likely to exceed available
supplies.
THE ROLE OF GOVERNMENT
In my remaining time I would like to acknowledge the efforts of
President Bush, the U.S. Department of Health and Human Services and
this Congress in preparing the United States for the next pandemic.
While GlaxoSmithKline is dedicated to doing its part to meet this
public health need, GSK does not view its commitment to pandemic
preparedness from a commercial perspective, and our investments in
pandemic preparedness would not have been made without some financial
investment and support from the Federal government. I know that the
administration and the Congress appreciate these realities. It is
appropriate and critical that a robust public-private partnership be
fostered to meet preparedness needs. I would like to describe examples
of how a strong government commitment is allowing us to make these
investments and suggest additional areas where government assistance
can help speed preparedness.
--To increase compliance with recommendations to administer the flu
vaccine, the reimbursement amount was increased to
approximately $18 for physicians who administer flu vaccine to
Medicare beneficiaries. This increase, along with an
educational campaign from the Centers for Medicare and Medicaid
Services (CMS) to increase flu immunization rates, was an
appropriate recognition of the work involved in vaccination as
well as a much needed encourage to help improve the uptake of
flu vaccine among the approximately one in three Medicare
beneficiaries who go without this critical yearly preventive
intervention.
--To help address a potential unanticipated supply shortage, HHS has
contracted with industry to purchase bulk monovalent seasonal
flu vaccine. This is a sensible approach to incrementally
increase flu vaccine capacity and supply while sharing the risk
between government and industry.
--To foster growth and competition in the U.S. vaccine industry,
Congress passed legislation that will reduce the risk of
frivolous lawsuits and minimize litigation burdens on companies
producing pandemic products. The new law provides avenues to
punish any bad actor companies, as well as a compensation
program for individuals who may be injured by a pandemic
product. Passage of this pandemic liability protection has
removed a major obstacle to industry participation in pandemic
preparedness in the United States.
--To move technology forward, a series of Requests for Proposals for
government grants in pandemic preparedness has been announced.
For example, one grant seeks to enhance the development of cell
culture flu vaccine, and another seeks ``antigen sparing
techniques'' to stretch supply. GlaxoSmithKline, along with
many of our industry colleagues, is participating in the grant
process.
--To achieve basic preparedness, the government is stockpiling
pandemic vaccine and antivirals. GlaxoSmithKline is currently
working with HHS on these projects.
GSK believes that the government can further help by putting in
place a series of measures aimed at creating sustainable demand for flu
vaccines. For example, the US government could:
1. Increase seasonal flu vaccination programs and expand the public
health recommendations for domestic seasonal influenza vaccination
toward universal mass vaccination. Strategies to enhance annual
influenza vaccination are good for public health and also would
increase the amount of seasonal influenza vaccine the world produces,
therefore building the necessary capacity that would be required in the
event that seasonal influenza vaccine production would be switched to
pandemic flu production were a pandemic to break out.
2. Continue support for the development of manufacturing
methodology that moves away from the current techniques that rely on
chickens and eggs. These methods have been used for over 50 years with
little refinement because the existing economic model has not provided
a reason to improve flu vaccine manufacturing.
3. Continue support for the development of vaccines using adjuvant
technologies to improve both effectiveness of current vaccines and
improve efficiency of pandemic influenza vaccine supplies. Adjuvants
offer the promise of using less antigen and thus stretching existing
supplies of pandemic vaccines.
4. Encourage development, licensure and use of new types of
influenza vaccines with the potential for broad protection against
severe influenza illness. These new types of vaccines could
substantially reduce the threat of pandemic influenza.
5. Increase support for research into monitoring the developments
of a potential flu pandemic outbreak. Industry will continue to rely on
government supported research on the influenza virus and surveillance
of how it may be changing.
6. In addition to acquiring and maintaining an appropriate
stockpile of pandemic products, enter into advance purchases of
prototype pandemic vaccines and antivirals to cover key front line
workers and high-risk groups.
These are a few examples of how the public-private partnership has
been working and can continue to work to ensure that the United States
is prepared to face the next influenza pandemic. GlaxoSmithKline has
been pleased with the dedication and commitment of the US government to
addressing this threat. Last year, the President requested $7.1 billion
in pandemic preparedness funding. Congress was able to provide about
half that amount, or $3.8 billion, at the end of last year. GSK is not
in a position itself to be able to quantify the total appropriate
levels of funding required to fully meet the country's pandemic needs,
but we do have confidence in the administration's ability to do so, and
GSK supports the administration's estimates of what is required. From
our perspective, funding would be most effective in advancing
technology and ultimately ensuring preparedness if it is provided in
multiyear commitments. Companies are making large investments to do
their part to assist with preparedness, and we need to be able to plan
around the government's role and ability to partner with us.
At GSK, we stand ready to assist the Subcommittee and the Nation on
the critically important and challenging issues of global preparation
for the next influenza pandemic. Thank you for the opportunity to
appear before you today. I would be happy to answer any questions that
the Subcommittee might have.
Senator Specter. Our next witness is Dr. Mary Mincer
Hansen, director of the Department of Public Health in Iowa,
bachelors' degree in nursing from Creighton University and her
master's in nursing in Texas Women's University, and a Ph.D. in
higher education from Iowa State. We have you on the docket for
3 minutes Dr. Hansen, proceed.
STATEMENT OF DR. MARY MINCER HANSEN, DIRECTOR, IOWA
DEPARTMENT OF PUBLIC HEALTH
Dr. Hansen. Thank you Senator Specter, members of the
subcommittee, Senator Harkin, Senator Stevens. On behalf of
Governor Vilsack, I am honored to be here today to address the
pandemic influenza issue. I would like to first thank you for
your support of public health and health care. As a result of
congressional investments our department has received funding
from the CDC and HRSA to prepare and respond to public health
emergencies such as pandemic influenza.
Some of our accomplishments include a Health Alert Network
which allows public health professionals, hospitals,
laboratories, emergency management agencies, law enforcement,
and veterinarians to receive health alerts.
Another important accomplishment is engaging the public. We
launched an education campaign called ``Protect Iowa Health''
to increase awareness about the importance of personal
preparedness and to inform Iowans of the role of public health
with such issues as quarantine and isolation.
We have also established volunteer disaster medical
assistance teams who can rapidly respond to any part of Iowa.
Our ability to mobilize these teams was demonstrated when we
deployed them to Florida and Louisiana.
Today we have an Emergency Capacity Reporting System that
allows us to obtain information quickly about hospital bed
capacity, pharmaceuticals, and other medical supplies. We
increased isolation capacity in our hospitals; we have
decontamination ability, as well as appropriate personal
protective equipment.
We still need to be better prepared. If the expectation is
for public health to be capable of responding to emergencies
24/7 then the Nation must invest in public health
infrastructure, technology, medicines, and health care surge
capacity. The pandemic appropriation for State and local public
health is woefully inadequate. Funding must be commensurate
with the roles and responsibilities public health agencies and
hospitals are being asked to carry out now and into the future.
We must be able to maintain and expand our workforce, without
them we will not be able to get the vaccines and antivirals to
our citizens. Expectations for protecting the public's health
do not come and go with funding; rather these expectations will
continue forever.
I would ask that you carefully review the expectation of
States to independently purchase antivirals. Not only are the
costs prohibitive, but the level of protection our citizens
receive should be standardized across the country. The recent
cuts to public health bioterrorism funding will directly impact
public health and health care capacity that has been built
since 9/11. Our alerting and communications systems will become
obsolete. Exercises will dwindle; equipment and technology will
become outdated. The investment of our country in public health
must be sustained to ensure a healthy future for all Americans.
In closing, I would recommend four things. Number one,
increased and sustain funding. Number two, national
preparedness standards and benchmarks developed with State and
local input. Number three, consistent Federal interagency
collaboration and coordination. A national program for vaccine
and antiviral purchase and stockpiling.
PREPARED STATEMENT
Thank you again, for the opportunity to testify before the
your committee. We in public health are grateful for the
foresight you demonstrated in providing an initial investment
in pandemic influenza preparedness and response. These
investments are critical to fulfilling our mission of
protecting the health of the citizens we all serve.
Senator Specter. Thank you very much Dr. Hansen.
[The statement follows:]
Prepared Statement of Dr. Mary Mincer Hansen
INTRODUCTION
Good morning, Chairman Specter and members of the Subcommittee. I
am Dr. Mary Mincer Hansen, Director of the Iowa Department of Public
Health. On behalf of Governor Thomas J. Vilsack, I am honored to be
here today to address the important issue of pandemic influenza.
I would like to thank you for your support of public health and
health care as we and our Federal and local partners work together to
protect the health of Americans. I also commend the U.S. Department of
Health and Human Services for its development and release of the
National Pandemic Influenza Plan. We have reviewed the plan and are
working to assure that our State and local pandemic plans integrate
seamlessly with the Federal guidance outlined in DHHS's plan.
FUNDING RECEIVED AND ACCOMPLISHMENTS
As a result of congressional investments since the tragic events of
9/11 our department has received funding from the Centers for Disease
Control and Prevention (CDC) and the Human Resources Services
Administration (HRSA) to prepare for and respond to public health
threats and emergencies such as pandemic influenza. With this funding,
the Iowa Department of Public Health and local public health partners
have made significant progress in our preparedness efforts and have
improved our public health and hospital response capability.
Some of our major accomplishments include the development and
implementation of our statewide Health Alert Network (HAN) system. The
HAN is a robust, redundant communication system allowing local public
health agencies, hospitals, laboratories, hazmat teams, emergency
management agencies, law enforcement, EMS, veterinarians and many
others to receive health alerts, share documents, and post
announcements We have also implemented a redundant communication system
by placing 800 mega hertz radios in all licensed hospitals, local
public health agencies, the State public health laboratory, poison
control center, all EMS helicopter services, and the State emergency
operations center and at the department. An excellent example of how
the HAN system in Iowa fosters multidisciplinary relationships is that
it is now used as an additional way to send Amber Alerts.
Another important accomplishment and ongoing effort is engaging the
public in our preparedness efforts. In August 2005, the Iowa Department
of Public Health launched an education campaign called ``Protect Iowa
Health'' to increase awareness among Iowans about the importance of
personal preparedness and to inform them of the role of public health
during an emergency. This campaign includes a booklet that provides
information on how to make a plan for communicating with loved ones and
how to make an emergency kit to be used in the event of a public health
emergency. It also informs the public about what types of actions
public health may take during an emergency, such as quarantine and
isolation.
Because we are a predominantly rural State we have also established
volunteer disaster medical assistance teams who can rapidly respond to
any part of Iowa. Issues relating to surge capacity are particularly
difficult for rural areas with fewer public health and healthcare
personnel. This places greater emphasis on building a network of
qualified surge responders. Our ability to mobilize these teams was
demonstrated by the fact that Iowa was one of the first States to
deploy our volunteer medical teams to both Florida and Louisiana
following devastating hurricanes over the last 2 years.
These examples show how current funding of public health has made a
significant difference in our capacity to protect the health of Iowans
and respond to pandemic influenza. Prior to receiving this funding we
had two epidemiologists at the State level and one at the local level.
Today we have one epidemiologist for every 500,000 population. Three
years ago we did not have an emergency alerting system or redundant
communication connecting all hospitals and public health agencies nor
could we quickly gather information about hospital bed capacity,
pharmaceutical or other medical supplies. Today we have an Emergency
Capacity Reporting System that allows us to obtain this information
quickly. We have increased isolation capacity in our hospitals and all
hospitals have decontamination capability and appropriate personal
protective equipment. Additionally all hospitals and public health
agencies have participated in incident command training.
ROLES AND RESPONSIBILITIES OF PUBLIC HEALTH
Prior to a pandemic, local and State public health departments will
function as an early warning system. State and local public health will
be responsible for surveillance--detecting outbreaks of disease and
identifying pandemic influenza strains. When pandemic influenza is
detected, State, and local public health will be responsible for
implementing appropriate prevention and control measures. These
measures include providing timely, accurate, and consistent information
on vaccine prioritization and use, antiviral use for treatment and
prevention, infection control and treatment and care of patients.
Public health laboratories will ensure proper collection, transport and
testing of highly infectious influenza specimens. This is all done
during a time when we must also help to ensure continuity of operations
by keeping vital societal services going to mitigate the impact of a
pandemic on human health, the economy, government and the private
sector.
WHAT WE ARE DOING TO PREPARE FOR A PANDEMIC
The Iowa Department of Public Health has developed a pandemic
influenza response plan working with our local public health and health
care partners and other State agencies. Exercises have been completed
in our six regions for hospital preparedness and a State exercise will
be completed in February focusing on our incident command and
management system to evaluate effectiveness of interagency coordination
between homeland security, agriculture, law enforcement, public health,
health care and others. Additionally a virtual functional exercise will
be conducted in March to test our epidemiology response on the local
and State level. Iowa will be holding our Pandemic Summit this Friday
with Governor Tom Vilsack and U.S. Secretary Mike Leavitt, including
Senator Tom Harkin and other Congressional representatives, to engage
business, schools, faith-based communities and others in our pandemic
preparedness activities. Other activities that are being planned
include the development and implementation of operational procedures
specific to pandemic influenza; ongoing public education regarding
prevention and containment measures; development of antiviral
stockpiling plans; development, implementation and exercising of off-
site care facility plans for providing healthcare; and development and
distribution of guidance for health care clinics related to surge
capacity and review of stockpiling durable goods and supplies.
WHAT PUBLIC HEALTH NEEDS TO BECOME BETTER PREPARED
Our State and local public health system has been under funded for
decades. We as a country now realize that public health is a critical
asset and must be strengthened to provide the foundation for a strong
America. Federal, State, and local public health entities have assumed
preparedness responsibilities that require a strong system foundation.
If the expectation is for public health to be prepared and capable of
responding to emergencies 24/7 then the Nation must invest in public
health infrastructure, the technology, medicines, and health care surge
capacity that are necessary to save lives and mitigate suffering from
pandemic influenza and other public health threats and emergencies. An
adequately funded, coordinated Federal, State, and local public health
response is essential if we are to care for the public during an
influenza pandemic.
The pandemic appropriation for State and local public health is
woefully inadequate to build the infrastructure that is necessary to
protect the citizens of our Nation against this potentially lethal
virus. Funding must be commensurate with the roles and responsibilities
State and local public health agencies and hospitals are being asked to
carry out now and into the future. We must be able to maintain and
expand our workforce, without them we will not be able to get the
vaccines and antivirals to our citizens. Expectations for protecting
the public's health do not come and go with funding; rather these
expectations will continue forever.
I would ask that you carefully review the expectation of States to
independently purchase antivirals. Not only are the costs staggering
and an unrealistic expectation, but the level of protection our
citizens receive should be standardized across the country. There must
be a national commitment for antiviral purchase and stockpiling. In
addition, all Federal inter-agency preparedness activities must be
coordinated at the national level prior to dissemination and request
for implementation at the State level. Federal partners need to obtain
State and local input when defining policy, developing plans and making
funding decisions. Clear well defined baseline national preparedness
standards that are measurable and sustainable must be developed.
Lastly, proposed cuts to the public health bioterrorism program
will directly impact public health and health care capacity that has
been built since 9/11. Our alerting and communications systems will
become out of date and we will not be able to maintain the systems.
Planning meetings and exercises will dwindle, equipment will age and
technology will pass us by again. Education and training of public
health professionals will no longer be a priority and there will be
minimal investment in public information and education. The
reinvestment of our country in public health must be sustained to
ensure a healthy future for all Americans.
CLOSING
Thank you for the opportunity to testify before the Senate
Appropriations Subcommittee. We in public health are grateful for the
funding you have allocated for the CDC and HRSA Bio-terrorism programs
and for the foresight you demonstrated in providing an initial
investment in pandemic influenza preparedness and response. These
investments are critical to public health and health care fulfilling
our mission of protecting the health of the citizens we serve.
Senator Specter. Our next witness is Dr. Calvin Johnson,
secretary of the Pennsylvania Department of Health. Graduate of
Morehouse College with a degree in chemistry, M.D. and masters
in public health from John Hopkins University. I thank you for
joining us Dr. Johnson and we have you down for 3 minutes.
STATEMENT OF DR. CALVIN B. JOHNSON, SECRETARY,
PENNSYLVANIA DEPARTMENT OF HEALTH
Dr. Johnson. Thank you Senator, good morning Chairman
Specter, Senator Harkin, Senator Stevens. On behalf of Governor
Ed Rendell, from Pennsylvania thank you for this opportunity to
address the committee about pandemic influenza planning. For
States preparing, preparing for, and responding to, a pandemic
means coordinating the response, maintaining essential health,
public health and other general services; and obtaining and
distributing vaccines and antivirals, among other activities.
The national plan unveiled in November places the majority
of responsibility for prevention, protection, response and
recovery, on State and local health departments. For States to
minimize illness, and death in an influenza pandemic, there
must be a sound public health infrastructure. This includes the
capacity to detect disease, disseminate timely and accurate
information, and to maintain a well trained public health
workforce.
Pennsylvania has used Federal preparedness funding to
further develop and improve disease surveillance, rapid health
communications, and workforce training. All of which are
components of public health infrastructure. Electronic disease
surveillance improves the timeliness and accuracy of disease
reporting. We have developed the Pennsylvania National
Electronic Disease Surveillance System (PA-NEDSS), and have
built it into a nationally recognized surveillance system.
Timely and accurate information delivered to health
professionals and the public saves lives. In Pennsylvania our
health alert network, provides real time health information and
updates to public and private health partners based on reports
from PA-NEDSS. A well trained public health workforce is
crucial to an effective plan and response to pandemic influenza
and other public health emergencies.
Pennsylvania learning management system provides online
training and continuing education in many areas including
bioterrorism and hospital preparedness among others. These
examples of Pennsylvania's investments in influenza pandemic
and overall public health preparedness are also examples of
what States can do with dedicated resources.
Preparedness relies on more than one time investments and
sustain funding is necessary to ensure long-term improvement.
Just as the virus changes its makeup to adapt to whatever
threatens its survival, we have to find new and better ways to
address ever changing and emerging threats to our health and
safety.
In Pennsylvania we saw the value of preparing for all
hazards in responding to Hurricane Katrina aftermath and
managing the Nation's largest ever hepatitis A outbreak. Each
State faces individual challenges based on geography,
demographics, and resource availability. One size will not fit
all. So States must inform the planning process at the highest
policy levels, and from the beginning in order to--for guidance
to be clear useful and effective.
PREPARED STATEMENT
There are still gaps in preparedness, and States will need
to fill those gaps and have the funding flexibility to do so.
We recognize and appreciate Congresses support of the
Department of Health and Human Services, in providing the
guidance and resources they have to this point to State and
local health departments. We also thank you for recognizing
that States and their public health agencies are vital links in
ensuring that this Nation is prepared for any crisis.
Senator Specter. Thank you very much Dr. Johnson.
[The statement follows:]
Prepared Statement of Dr. Calvin B. Johnson
On behalf of Governor Edward G. Rendell, the Pennsylvania
Department of Health is honored to testify before the Subcommittee on
Labor, Health and Human Services and Education to address the important
issues surrounding influenza pandemic planning from a State's
perspective. Thank you for this opportunity.
Preparing for, and responding to, a pandemic will involve every
aspect of our lives. For States, this means providing a coordinated
response of the State and local governments, hospitals, and other local
responders to care for the sick; addressing the issue of isolation and
containment; maintaining essential health, public health and other
general services; and obtaining and distributing vaccines and
antivirals directly to the people, among other activities.
The national influenza pandemic response plan unveiled in November
2005 places the majority of responsibility for prevention, protection,
response and recovery, including those just mentioned, on State and
local health departments. To meet these demands, adequate and sustained
support from our Federal partners is required to build up a long
neglected public health system. And, because each State faces different
challenges and possesses different assets, the type and level of this
support must not be determined without solid State representation.
SOUND INFRASTRUCTURE IS CRITICAL TO MEETING RESPONSIBILITIES
The success of a national response to an influenza pandemic depends
upon many factors. Arguably, one of the most important components is
the preparedness and coordinated response of State and local
governments, hospitals, and other local responders. When an influenza
pandemic spreads worldwide and across the United States, the Federal
Government will not be the ones to care for the sick, enforce a
quarantine order, maintain essential public services in the community,
or distribute vaccines and antivirals directly to the public. This is
not meant to lessen the role that the Federal Government has played and
will continue to play in public health emergencies. Rather, it is
designed to ensure that we all keep in perspective the roles that all
levels of government, as well as the public health system, have in
responding to a public health emergency, specifically, an influenza
pandemic.
In the case of an influenza pandemic, the affected population will
be too widespread for the Federal Government to attack the issue alone.
State and local institutions will be largely responsible for critical
functions and ultimately for the health and safety of their citizens.
State public health agencies will be responsible for, among other
things: (1) coordinating the distribution and administration of
vaccines and antivirals at designated locations; (2) providing public
health nurses and other clinical staff to administer the vaccines and
antivirals to the public; (3) communicating with local, State, and
Federal officials to make sure all are kept abreast of the most recent
information and status; (4) working with the local health care system
to ensure that adequate beds and staff are available to care for those
who are sick; (5) maintaining a presence with State emergency
management agencies to ensure emergency management officials at all
levels have the necessary information to act; (6) managing
communication with the mass media to provide the public with the most
up-to-date information regarding the outbreak, vaccine locations,
precautions, and other facts to minimize the risk of panic, illness and
death among the public; (7) tracking the spread of the disease within
the State to arm officials with the information to identify vaccine
locations and bed capacity; and (8) issuing, in a worst case scenario
and as a last resort, quarantine orders if necessary.
To fulfill these and the vast array of additional day-to-day
responsibilities, States must have a strong public health
infrastructure. State and local governments recognize and take very
seriously these enormous responsibilities. Many States, including
Pennsylvania, have already made significant investments in their public
health infrastructure and emergency preparedness thanks to some
generous Federal support. Examples of a public health infrastructure
include:
--Health care facilities.--Hospitals, nursing homes, and other health
care facilities will be swarmed with individuals requiring
clinical services for influenza symptoms. Hospitals will face
an influx of individuals on a day-to-day basis. Nursing homes
must deal with the challenges of ensuring systems are in place
to address the needs of their residents, who, as we all know,
are among the most vulnerable when it comes to influenza.
Pennsylvania's pandemic plan estimates up to 38,000 residents
would be hospitalized for presence of the influenza virus and
nearly 1.6 million people would require outpatient care for
flu-like symptoms;
--Bed capacity.--States must ensure they have the necessary bed
capacity to care for not only those afflicted with the
influenza virus--what is sometimes referred to as surge
capacity--but also the other day-to-day illnesses that require
hospitalization;
--Emergency response system.--States like Pennsylvania rely on their
Emergency Management Systems (EMS) to not only respond to
citizens who fall ill and require medical attention, but also
provide prompt medical transport to the nearest hospital system
that meets their acute medical needs;
--Informed health care network.--A State health department is
responsible for disseminating timely and accurate information
to health professionals, hospitals, laboratories, other public
health partners and the general public. In Pennsylvania, we
utilize an electronic Health Alert Network (HAN) that provides
real-time health information and updates to key public and
private health partners. So, if our PA-NEDSS alerts us to a
sudden or unusual increase in a particular type of infection or
a cluster of clinical symptoms, health care professionals can
be informed of what to look for and how to treat, so lives can
be saved. To date, there are approximately 3,250 HAN users in
Pennsylvania.
--Workforce.--No influenza pandemic plan, or other public health
emergency plan, can function without a dedicated, competent,
and robust public health and health care delivery workforce.
Public health nurses will be called upon to organize and
administer vaccines and antivirals at mass immunization
clinics. Private nurses and physicians will be stretched thin
as their offices and hospitals are flooded with citizens
seeking medical attention for their symptoms. Epidemiologists
will be called upon to maintain the highest level of accuracy
and diligence as they survey and track the spread of disease.
There are many other examples of public health workers that
will be called upon in such a crises and States must be ready
with a strong workforce that is capable of implementing its
plan. Pennsylvania has created a Learning Management System
(LMS) that offers on-line instruction, training and continuing
education in a variety of topic areas, including bioterrorism
and hospital preparedness, weapons of mass destruction, and
response and recovery. LMS offers 250 courses and now has over
31,600 registered users in Pennsylvania; and
--Surveillance.--States will require a sophisticated surveillance
system that allows for early detection and close monitoring of
infectious diseases and other potential bioterrorism-related
conditions. The PA DOH continues to enhance the Pennsylvania
National Electronic Disease Surveillance System (PA-NEDSS), a
national award winning system for real-time, electronic
reporting of communicable diseases. The CDC has cited PA-NEDSS
as the ``gold standard'' for disease surveillance. The PA DOH
has also implemented the first-in-the-nation Real-time Outbreak
Disease Syndromic Surveillance System (RODS) that tracks
symptom clusters in both emergency room complaints and through
pharmacy purchases. For example, if unusual clusters of people
present with stomach pains and purchases of diarrhea medicine
in a particular area in the State, PA DOH can immediately
investigate to determine if an act of bioterrorism or other
public health threat is occurring. RODS was also recognized in
2005 by the RAND Corporation as one of 12 exemplary practices
in public health preparedness in a national study prepared for
the U.S. Department of Health and Human Services (HHS).
The aforementioned certainly underscores the complexity and depth
of a public health infrastructure. What should also be evident is that
a public health infrastructure is not dependent on one-time investments
of equipment or ``bricks and mortar.'' While these very tangible items
are certainly necessary, an effective public health infrastructure is
something that must be sustained with ongoing commitments from all
levels of government. Such investments will ensure that States can
continually prepare and respond to a variety of public health threats
with improved surveillance, communication systems and laboratories.
However, we should not be satisfied with the assurance that we can
mount a response; we must now set our sights higher with the goal of
achieving minimal human illness and morbidity and minimal social and
economic disruption in every State and every community.
PREPAREDNESS REQUIRES SUSTAINED SUPPORT
Furthermore, if at any point we become complacent and believe that
we have ``done enough'' or ``invested enough'' to prepare for a
pandemic influenza, we will ensure a failed response. For States, this
means enforcing a coordinated response of state and local governments,
hospitals, and other local responders to care for the sick, enforce
quarantine orders, maintain essential public health services in the
community and distribute vaccines and antivirals directly to the
people, to name a few. To meet these demands, adequate and sustained
support from Federal partners is required to build up a long neglected
public health infrastructure. Because each State will face different
challenges and will possess different assets, the type and level of
this support must be determined with solid State representation.
An investment in preparedness is never wasted. Whether public
health crisis is natural or manmade, there will be substantial return
on that investment. The tragic events of 2005--particularly the lives
lost and destruction caused by Hurricanes Katrina, Rita and Wilma and
the Asian Tsunami--are a grim reminder of the unpredictable nature of
weather caused calamities and other public health emergencies. Reaction
to these disasters is a perfect example of how implementing an all-
hazards approach and multiplied benefit of investment in preparedness
provides a return on investment by saving lives and money.
Pennsylvania, along with the rest of the United States, recognizes
government's core responsibility to protect its citizens; and the role
that public health and safety plays in helping to determine the quality
of our lives and the shape of our communities.
STATES MUST INFORM THE PROCESS
Our generation has not experienced an influenza pandemic--however,
our not so distant history reveals that three pandemics occurred in the
last century in 1918, 1957 and 1968. These pandemics killed
approximately 40 million, 2 million and 1 million people respectively
worldwide. An influenza pandemic is a global issue that will challenge
our health care systems, impact our work force, temporarily change the
way we travel, purchase goods and interact. The HHS likens the
potential pandemic risk from avian influenza to the 1918 Spanish Flu
which was devastating, costing us 20-40 million lives world wide--HHS
anticipates with modern treatment and prevention that the U.S. death
count could result in 2 million lives lost with over 10 million people
requiring hospitalization. In Pennsylvania, we estimate that nearly
9,100 lives will potentially be lost during an influenza pandemic.
Clearly, all States must continually prepare for such a threat. Policy
decisions that determine and direct resources to planning efforts must
fully engage all levels of government.
From Pennsylvania to Florida to Texas to Alaska, all States will
face different challenges in preparing for a pandemic. State's public
health systems will vary from State to State with some having
intricate, fully-developed local or county-based health systems, while
others will rely mainly on the State public health entity. Still
others, like Pennsylvania, face the task of working in a mixed
environment where some areas have a local health department and others
will lean on the State. States will have different procurement
processes, different administrative policies, different private health
care delivery systems, different levels of authority, and, of course,
different legislatures and governors. This diversity must be recognized
and supported with Federal funding that provides States with the
discretion and flexibility to develop plans and invest dollars in a
manner that best suits the organization, capacity, geography, and
resources that each State possesses.
The greatness brought about by the diversity of our Nation
manifests itself in so many ways. Each State has unique characteristics
that are relevant to pandemic planning and response. Each faces
particular challenges based on geography, demographics, and resource
availability, to name a few. These differences demand that State,
local, and Federal governments maintain open and effective
communication. One size will not fit all, so States must inform the
planning process at the highest policy levels and from the beginning in
order for guidance to be clear, useful and effective and for resources
to be adequate.
A STATE'S INVESTMENT IN PUBLIC HEALTH PREPAREDNESS AND RESPONSE
It is important to understand what activities and systems a State
has developed as part of pandemic preparedness efforts. Pennsylvania's
ability to respond to such public health emergencies is enabled by
intense planning, guided by decisions made with input from all levels
of government and cross-agency coordination. This planning has
noticeably improved Pennsylvania's readiness capabilities over the past
three years. The PA DOH has been working with the Pennsylvania
Emergency Management Agency, the Pennsylvania Department of Agriculture
and other State, local, and Federal agencies and numerous volunteers to
establish a coordinated approach to pandemic planning. To put a finer
point on the discussion, history, particularly in Pennsylvania,
demonstrates the need for a sustained investment of dollars and other
resources to preparedness.
Avian Influenza (AI) is not new to Pennsylvania's poultry. In 1983,
an avian influenza outbreak in Pennsylvania's poultry industry led to
the destruction of 17 million birds. It is important to note that, like
human disease, there are numerous strains of avian influenza and there
are dozens of detections of low risk (to humans) strains of avian
influenza in Pennsylvania each year by the Pennsylvania Department of
Agriculture. The detection of the disease leads to a determination by
the Department of Agriculture of the most appropriate response--a
response that could include quarantine of the farm or destruction of
the fowl.
As a result of the outbreak in 1983 and the ongoing surveillance
efforts implemented by the Pennsylvania Department of Agriculture,
Pennsylvania has become a leader in the prevention, detection and
response of AI in the country's poultry population.
Nonetheless, there remain two main categories of threat to
Pennsylvania, and other States alike--the threat to our poultry
industry and the threat of a global human influenza pandemic outbreak.
It could be a virus that spreads more easily, is more deadly, or may
cause more health complications. With no ``weapon'' available for a
State or Nation to stop the influenza virus from spreading so rapidly,
coordinated response and recovery efforts are essential for saving
lives. Perhaps one point that has been overlooked so far is the
inevitability of a pandemic influenza. This is not an ``if'' scenario.
Preparing Pennsylvania, and the Nation, for a pandemic is a ``when''
proposition.
Under the direction of Governor Rendell, Pennsylvania has taken
numerous steps in preparation for this threat. They include:
Establishment of Task Forces to Address Agricultural and Health
Preparedness.--Two task forces have been created to prepare for the
increased threat of an H5N1 outbreak in Pennsylvania's bird population
and one to ensure that the Commonwealth is preparing to detect, prevent
and respond adequately and timely to this potential threat. The goals
of both task forces are to identify any potential gaps in
Pennsylvania's planning efforts and develop unique and integrated ideas
for closing the gaps.
Agriculture--Avian Influenza Response Plan.--The Pennsylvania
Department of Agriculture has developed an Avian Influenza Response
Plan which describes the procedures for potential or actual presence of
AI in poultry in the Commonwealth. The plan does not just focus on
response, but addresses all aspects of preparation including
prevention, protection, response and recovery. This plan is now the
basis for ongoing discussions, planning sessions and activities with
State, local, and Federal partners. The plan is available on the
Department of Agriculture web site.
Health--Pennsylvania's Pandemic Plan.--The PA DOH has released
Pennsylvania's Pandemic Influenza Response Plan for the public to
review and use for planning purposes. Again, this plan focuses on
prevention, protection, recovery and response. This document is the
basis for six work groups that are addressing remaining details and
policy questions that have arisen through the creation of
Pennsylvania's Plan. The Plan is available on the PA DOH's web site at
www.health.state.pa.us.
Health--Detection, Prevention and Response Efforts.--The PA DOH has
upgraded its State public health laboratory to Biosafety Level 3
capabilities and recently renovated it so that it is now equipped with
a level 2 chemistry laboratory that has successfully participated in
proficiency testing events. In addition, the PA DOH continues to
enhance two key surveillance systems--PA NEDSS and RODS--that provide
Pennsylvania with the latest disease surveillance technology.
Communications to Local Government.--As part of its preparedness
activities, PA DOH has been fully engaged with local partners from
throughout the Commonwealth to assure local needs and community
capacity are met.
Continuity of Government.--Each agency under the Governor Rendell's
jurisdiction has been directed to develop and maintain a continuity of
government plan to determine essential resources and key business
functions and to review work force policies and procedures that may
require modification.
However there is more that Pennsylvania will do.
For example, the PA DOH is currently working with HHS to conduct a
pandemic summit in Pittsburgh that will include businesses, hospitals,
local government, schools, universities and other groups. The purpose
of the summit will be to provide outreach and education to all
Pennsylvanians on the activities underway across the State, but more
importantly outline what all Pennsylvanians can do to prepare. Sessions
will address the following areas:
--Human Avian Influenza Prevention Detection Policies and Processes;
--Work Force Planning;
--Isolation and Quarantine Procedures;
--Vaccine and Medication Distribution;
--Incident Coordination and Response (Command and Control);
--Surge Capacity; and
--Public Communications and Outreach Planning.
Despite substantial progress in Pennsylvania, and the continued
work with local and Federal partners that lies ahead, there are several
gaps in the system that need to be addressed to enable a more seamless
response. The biggest gap is in the public health infrastructure.
Pennsylvania has a small census of public health staff that is already
stretched to meet their routine daily challenges. This gap leaves
little time for grass-roots public health staff to work with
communities and individuals for pandemic planning activities such as
planning, education and evaluation of readiness. Other areas that
Pennsylvania will continue to address once Federal guidance is provided
are as follows:
--Enhance systems and capabilities for large scale dissemination of
public information, including public and health professional
awareness;
--Develop and disseminate shelter-in-place guidelines;
--Enhance and sustain a well coordinated regional and State surge
planning effort;
--Convene a panel to explore the issue of alternative care sites,
including staffing and supplies;
--Identify core competencies for health professionals during a large
scale emergency and develop training programs;
--Refine hospital staff credentialing and operationalize mutual aid
agreements;
--Inventory available equipment purchased through HRSA funds; and
--Identify intrastate and interstate (EMAC) mutual aid agreements.
CONCLUSION
Pennsylvania and its Department of Health recognize the enormous
challenges that lie ahead. We also recognize that we have been given
significant resources, particularly through Federal funding, to help us
meet these challenges. We understand that each State will face
different challenges, possess different resources, and have different
needs for effective preparedness.
These differences demand that State, local, and Federal government
maintain open and effective communication. When a disaster occurs,
whether it is a pandemic influenza, other natural disaster or act of
terrorism, all levels of government will have a role and
responsibility. Funding should be based on State's needs to ensure that
what is being allocated is adequate to meet those needs. The State
variety also requires that funding be based on individual State's needs
to ensure that what is being allocated is enough to meet individual
needs. One size will not fit all, so States must inform the planning
process at the highest policy levels and at the beginning in order for
guidance to be clear, useful and effective.
Pennsylvania commends Congress's support of Health and Human
Services agencies in providing guidance and support to State and local
health departments, and strongly encourages these agencies to involve
State and local health departments at every level as new guidance and
initiatives are developed. We also strongly and respectfully encourage
Congress to continue these wise investments in public health
preparedness so that States, and the Nation as a whole, can continue to
enhance preparedness efforts for a pandemic influenza as well as other
public health emergencies. State public health agencies can meet their
responsibility with sustained commitments from all levels of
government. This will assure that the differences in State's
infrastructures and needs are accounted for and States are not left to
face a ``one size fits all'' quandary.
Pennsylvania and all other States are committed to using these
resources wisely. After all, the same resources that will enhance our
ability to deal with preparedness will also support our day-to-day
efforts to improve the health of all Americans, and provide an
infrastructure to successfully detect and cope with any public health
preparedness situation--whether that emergency results from an
influenza pandemic, a natural disaster, the accidental release of toxic
material, or a terrorist attack using a chemical or biological agent.
On behalf of Governor Rendell, thank you for inviting the
Commonwealth of Pennsylvania to present this testimony.
Department of Health,
Harrisburg, PA, March 8, 2006.
Hon. Arlen Specter,
U.S. Senate, Washington, DC.
Dear Senator Specter: On behalf of Governor Rendell and the
citizens of the Commonwealth, I would like to again thank you for
extending an invitation to the Governor to testify before the U.S.
Senate Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies hearing on influenza pandemic.
During the hearing, you asked that I follow-up with you in writing
to provide information on what resources Pennsylvania needs in order to
protect its 12 million residents in the event of an influenza pandemic.
In addition, you asked for information on what State resources have
been, and will be, dedicated to influenza pandemic planning.
Question. Have the Federal allocations for Pennsylvania's pandemic
planning been enough to support planning efforts to protect its over 12
million citizens? If not, what is needed and how much will this cost?
Answer. Pennsylvania has been notified that it will receive
$3,508,291 in Federal funds for the first phase of State pandemic
influenza response initiatives. By contrast, just the cost of providing
antiviral medications to critical emergency responder personnel and
their families will triple this amount, reaching closer to $11 million.
This figure estimates a cost of $24 per course of antiviral medication,
which is multiplied by: 1,300 public health workers; 5,875 State police
officers; 56,000 EMS; and 81,000 firefighters and volunteer
firefighters. Please note, this figure does not take into account the
number of physicians, hospital personnel, sheriffs and other critical
personnel necessary to maintain order and ensure the public's safety
during a pandemic.
Clearly, the amount allocated for the first phase is not sufficient
to continue planning efforts in Pennsylvania. For instance, the
following is a list of pandemic planning activities and activities that
will require additional resources and on-going funding:
--Keeping the public health workforce and the emergency response
infrastructure in place in order to care for the sick and
manage the pandemic response. This includes resources to keep
the families of first responders healthy during a pandemic.
--Administrative costs for recruiting and organizing non-medical
volunteers to assist with special needs populations; mass
decontamination; post hospitalization mass movement;
mobilization of burn/trauma/pediatric specialists; and
coordination of services during isolation/quarantine, and other
activities.
--Mass prophylaxis protocols for distribution of antivirals.
--Administrative costs for staffing Point of Dispensing Sites.
--Stockpiling of potential vaccines and antivirals, and managing
shelf life and medication rotation.
--Development of a State-specific Pennsylvania Emergency System for
the Advance Registration of Volunteer Healthcare Professionals
(ESAR-VHP) System to allow for the advance registration and
emergency credentialing of volunteers.
--Training and participation in the ESAR-VHP System.
--Professional liability and workers compensation protection for all
emergency volunteers enrolled in ESAR-VHP in the event of a
governor-declared emergency.
The Department estimates that the above-mentioned activities alone
will cost approximately $393,000,000 to fully implement. Attached for
your review is a detailed breakdown of what the Department estimates it
will cost to fully engage Pennsylvania's planning and response efforts
for an influenza pandemic.
Question. What State resources have been used to help support
efforts? What does the Governor plan to do to support these resources?
Answer. The success of a national response to an influenza pandemic
depends upon many factors, and requires, as its foundation, a strong
public health infrastructure. The Pennsylvania DOH, and its sister
agencies, including the Pennsylvania Department of Agriculture (PDA)
and the Pennsylvania Emergency Management Agency (PEMA), have invested
a significant amount of time and resources to protect against the
spread of an influenza pandemic.
Governor Rendell has proposed to invest $500,000 for State fiscal
year 2006-2007 for PEMA to coordinate with DOH on the Commonwealth's
avian flu and pandemic preparedness efforts. In addition, the State has
dedicated staff resources to pandemic planning efforts. Over the past 6
months, an estimated 2,300 hours in personnel time have been spent on
pandemic planning which translates into over 300 working days directed
to this important issue. At this point, the associated costs, including
salaries, are approximately $80,000. As you know, pandemic planning
will be an ongoing priority, and the State will continue to use the
resources necessary to protect the citizens of Pennsylvania.
In order to protect the citizens of this Commonwealth from an
influenza pandemic, States, such as Pennsylvania, will need continued
Federal investments and greater flexibility in using Federal resources.
I am confident that with your sustained support and our commitment to
planning, Pennsylvania will be well-positioned to meet the demands of
an influenza pandemic and a variety of other public health emergencies.
Again, on behalf of Governor Rendell, I thank you for your interest in
this important issue. Should you have questions or need additional
information, please do not hesitate to contact me directly, or Mike
Yantis, Director of Legislative Affairs at (717) 783-3985.
Sincerely,
Calvin B. Johnson,
M.D., M.P.H.
Senator Specter. We now turn to Dr. Bruce Dixon, director
of the Allegheny County Health Department, Associate Professor
of Medicine at the University of Pittsburgh School of Medicine,
bachelors' and MD degrees from the University of Pittsburgh. We
welcome you here Dr. Dixon and look forward to your testimony,
we have you down again for 3 minutes.
STATEMENT OF DR. BRUCE W. DIXON, DIRECTOR, ALLEGHENY
COUNTY HEALTH DEPARTMENT
Dr. Dixon. Thank you Senator Specter and Senators Harkin
and Stevens. It's a pleasure to speak before you. All public
health to my mind is basically local, because it's at the local
level that we interact with our citizens. If we do a good job,
we do it well, if we don't all of the preparedness that we put
into it doesn't work terribly well.
I have some concerns as does Senator Stevens about
laboratory capacity. I would start with that, because basically
we do not have a laboratory in western Pennsylvania of a public
health sort that can identify an infectious agent, whether
avian flu or anything else.
We've tried to get one up, but it's been stymied in a lot
of ways and funding is certainly necessary to get this in
place. In Pennsylvania the only public health laboratory is
located outside Philadelphia, where the technology is available
to identify something within 15 or 20 minutes, it takes us
about 36 hours to get a specimen over there and to get results
back. So it's incumbent that we do get this laboratory up,
because not only do we want to recognize something such as
avian flu, we want to be able to tell our citizens that there
is not a risk, and that negative result is probably as
important as a positive result in many instances in calming the
panic that sometimes occurs around this. So that's my first
point I'd like to make.
Second of all, I want to point out that we really need to
regionalize our efforts. You're familiar with region 13,
Allegheny County and surrounding 12 counties have joined
together so that we will work collaboratively to try to deal
with any sort of an emergency, whether we're talking avian flu,
or anything else. We really need to regionalize even further
than that, unfortunately we craft geopolitical lines for public
health purposes and patients don't work that way. They cross
those lines, we should really, if we get a laboratory up be
looking at doing things for eastern Ohio, and northern West
Virginia as well.
So this is a new way of thinking about how we approach
public health. It's important I think that we recognize also
that we have a dynamic relationship with the emergency
management. Sometimes those lines get a little bit confusing as
to who does what. It's very clear in the case of avian flu,
this is a public health issue, but we need to work with our
emergency management agencies as well to deal with that.
One of the things that I think that we have in Allegheny
County that works quite well is two major health institutions,
the University of Pittsburgh and the Allegheny West Penn
System. We work very closely with our partners so I feel that
we're probably as well prepared as any region of this country
to deal with avian flu, although we do have our gaps.
We've demonstrated that last year when we had a shortage of
a routine flu vaccine, we were able to in a very short period
of time; in five days medicate over 20,000 people at a single
site. We feel we have a medical reserve corps that has over
10,000 volunteers of a public health nature who have
volunteered for that, we feel with multiple sites, and we would
use our school districts, we could immunize our population
within 48 hours. We would set up also satellites areas where we
could evaluate people, to keep people from going to the
hospital and allow those healthcare institutions that we have
to remain on the alert for people who are seriously ill.
PREPARED STATEMENT
So I think we're quite well prepared, we certainly though,
and I would echo Dr. Johnson's comments, we need a steady
stream of funding, because we've had peaks and valleys and the
public health infrastructure is tremendously lacking throughout
this country, including western Pennsylvania, and we need
increased funds to do some of the things that we need to do. I
thank you for the opportunity to talk with you.
Senator Specter. Thank you very much Dr. Dixon.
[The statement follows:]
Prepared Statement of Dr. Bruce W. Dixon
Senator Specter and Other Distinguished Dignitaries: I am honored
to be speaking before your distinguished committee. I have been the
Director of the Allegheny County Health Department for over a decade
and during that time have seen several accomplishments, both regionally
and locally, which I feel positions our region to be as well or more
equipped to handle either a man-made or naturally occurring emergency
than any other region of the country. We have regularly risen to any
occasion and worked together, whether an emergency due to flooding or
infectious disease, has occurred. Our approach to avian influenza would
parallel our efforts in dealing with any other public health emergency.
Having said that, however, there are several inadequacies which prevent
us from being totally prepared to deal with this problem.
First and perhaps central is the lack of adequate laboratory
facilities to rapidly identify an infectious agent such as H5N1 (avian)
influenza. Unfortunately, we received funding to begin construction of
a Bio-Safety Level III laboratory in 2002, and I regret to say that
there has been no construction of such a laboratory to date. The only
Public Health laboratory in Pennsylvania is that of the Pennsylvania
Department of Health located in Lyonville, outside of Philadelphia.
While the technology exists to identify a hazardous agent in as little
as twenty minutes, it takes us a minimum of 24 hours to submit a
specimen to this laboratory due to travel time, and there is concern if
we were to have a serious event in Pennsylvania that the capacity of
that laboratory would be exceeded. If constructed, a laboratory in
Pittsburgh would in the event of an emergency serve all of Western
Pennsylvania including the northeast, and conceivably could accept
specimens from eastern Ohio and Northern West Virginia as well. Any
emergency response starts with identification and even a negative
result allows for better dissemination of information that there is not
a serious threat, which is an important factor in preventing hospital
emergency rooms from being overcrowded with worried patients and in
reducing panic. The lack of such a laboratory is unconscionable and
must be addressed soon.
As you may be aware, Southwestern Pennsylvania counties have joined
together in an agreement to support each other in the event of
emergency and this arrangement known as Region 13 made up of Allegheny
and the surrounding 12 counties has attracted national attention. There
is a dynamic interplay in this collaboration, however, between
Emergency Response as manifest by County and local Emergency Response
Coordinators, and the public health component served by the Allegheny
County Health Department and the Pennsylvania Department of Health,
which has responsibility for the public health needs of the surrounding
12 counties. Both the ACHD and Pa DOH are severely limited in
personnel--Allegheny County Health Department, at present, has more
personnel than the Southwest District of the Pa Department of Health,
which must serve a much larger geographic area--and neither has
sufficient personnel to handle an infectious disease emergency without
large numbers of external personnel to lend assistance. The problem of
Southwestern Pennsylvania is further compounded at least for Allegheny
County in that we need to interact with elected officials and emergency
response coordinators in 130 different municipalities, unlike
Philadelphia where there is a single municipality and single Emergency
Management coordinator. The ability to communicate electronically and
by means such as hand held devices remains a problem with all these
myriad agencies using different frequencies and needs to be addressed.
A similar lack of consistency exists with our Federal agencies
including law enforcement. It is actually easier to communicate with
our State public health partners where we share radio frequencies. The
public health infrastructure of the State and region must be
strengthened or at least the erosion of personnel stopped. Salaries are
a major factor in attracting and retaining trained personnel.
At the Federal level there is confusion between the roles of
Emergency Management and Homeland Security and the roles of Public
Health, as represented by the Centers for Disease Control and
Department of Health and Human Services. It is not clear who is
ultimately ``in charge'' and this same confusion exists at the State
and local level. While we work collegially well, there needs to be
better clarification of role and responsibility. As an example, during
the Anthrax scares of 2003 the FBI was put in charge since this might
have been an act of terrorism. Their role was to develop a case which
would stand for prosecution regardless of the time necessary to do so.
The role of Public Health on the other hand was to as rapidly as
possible determine whether there was an infectious agent present so
that in the event there was, the public health measures of isolation
and treatment could be instituted to reduce the likelihood of
additional infections, as well as control panic by announcing negative
results. Public Health was comfortable with 95 percent accuracy in the
shortest possible time; law enforcement required 100 percent accuracy
regardless of the time needed. We solved the problem locally by
initially splitting specimens and after some discussion law enforcement
was comfortable with Public Health taking the lead, but valuable time
was wasted in negotiating the responsibilities of each which could be
better served if there was better delineation of responsibility.
In planning for avian influenza (or any respiratory infectious
agent) we have worked closely with our hospital partners, and have
developed carefully considered plans to deal with large numbers of
people who might become ill. We would establish centers to provide
prophylaxis--either oral or injectable medications including vaccines--
using our local high schools. We plan on establishing, again with our
hospital partners and medical community, evaluation sites where
individuals with symptoms can be evaluated, separate geographically
from sites, administering preventive medication to prevent potential
infectious individuals from spreading an infection to asymptomatic or
non infected ones. This should help to keep individuals from seeking
care primarily at an emergency room and allow our hospitals to care for
those most severely afflicted and in need of intensive hospital care.
We are the recipient of a Medical Reserve Corps Grant and have enrolled
several thousand medical volunteers, including physicians, nurses,
pharmacists and support personnel to help in this effort. We have
inventoried equipment and supplies which may be needed and continue to
plan for contingencies. Our partners in other counties of Region 13
would be called upon to assist if the system should be overwhelmed.
I should note that there is a need for better coordination of
funds. Multiple funding streams from the Federal Government seem to
arise with little coordination which results in duplication and
unnecessary expenditures which could be more profitably used.
Lastly, I should comment on the Pa Department of Health. The
present Secretary is very talented and has been a refreshing addition
to the Department, being the first physician secretary in almost a
decade. However, his short tenure--they change usually after 4-8
years--does not allow for long term planning and this is an essential
ingredient in assuring a consistent plan and message for the citizens
of Pennsylvania. A mechanism needs to be developed to allow for a
longer term.
Thank you for the opportunity of commenting on our readiness and
problems which we face. We look forward to working with you and our
local, regional, and State partners to continue to assure exemplary
service for our citizens in time of need.
Senator Specter. Our next witness is Dr. Joanne Godley,
acting commissioner of the Philadelphia Department of Public
Health, bachelors' degree from Stanford, M.D. and master of
public health from Neil University. Thank you for coming in
today Dr. Godley. We have you on the agenda for 3 minutes.
STATEMENT OF DR. JOANNE GODLEY, ACTING COMMISSIONER,
PHILADELPHIA DEPARTMENT OF PUBLIC HEALTH
Dr. Godley. Thank you Senator Specter, Senator Harkin,
Senator Stevens. Thank you for inviting me to participate in
this hearing regarding our national preparedness for an
influenza pandemic.
I am going to speak to you as a bioethicist, I recently got
that from the University of Pennsylvania and as Public Health
Commissioner. I'm passionate about issues that deal with the
equitable allocation of health resources, and social justice in
health. As a scientist I analyze problems and ask, where are
the gaps and where are the opportunities.
Senators, if we use the analogy of the influenza pandemic
as a train, I would say that it's heading straight for us, and
that we are not prepared. Where are the gaps? We have a
multitude of pandemic influenza preparedness plans. There are
several Federal plans, the States and local jurisdictions have
been charged with the responsibility of developing plans, but
there is a lack of integration. The lack of cohesiveness in our
healthcare system is reflected in the fragmented approach that
we've taken toward this impending pandemic.
I won't spend much time discussing vaccines; I would say
that we should not rely on vaccines to see us through this.
With regard to antivirals, the need to begin an antiviral
within the onset, the immediate onset of symptoms speaks to
having public stockpiles of antivirals. I say public because
the virus will infect individuals indiscriminately. An
inability to pay for medication should not be a barrier to
receiving effective treatment. Early effective treatment of one
individual could critically impact an entire community's
health.
I would say that the three biggest gaps at the local level
are our inability to augment local medical care, from the
outpatient level, from the hospital level, from the mortuary
level. Second would be our inability to have developed a
continuity of business plan, and involving public partnerships
at the local level. Third is the lack of a public health
campaign around this issue.
After Hurricane Katrina hit the gulf coast and the tragic
flooding ensued, within hours the tiny island of Cuba mobilized
more than a 1,000 medical care practitioners. These were nurses
and doctors who were trained in medical relief operations and
who were literally placed on call to travel to the United
States even with supplies.
The country whose GNP is a mere fraction of ours can
respond to an emergency in that fashion, why can't we? I would
ask that the Federal Government provide oversight in
integrating the many pandemic influenza plans and assume
leadership in developing a truly cohesive response.
I think standardization is a good concept. For example,
Philadelphia does not have a Federal quarantine office, within
Philadelphia, it is at JFK airport, so that the cross
jurisdictional issues would be a factor in Philadelphia.
Federal Government should create a funding stream to provide
stockpiling of durable medical goods such as mechanical
ventilators and personal protective equipment.
Philadelphia has a shortage of nurses, and doctors. Federal
legislation would make it easier to rely on retired physicians
for personnel surge capacity. Federal legislation could
facilitate the mobilization, and deployment of a medical
reserve corps----
Senator Specter. Dr. Godley, could you summarize at this
point?
PREPARED STATEMENT
Dr. Godley. Sure. Finally the Government could take the
lead in the development of a social marketing campaign about
pandemic influenza, the public needs to be informed about what
is coming and educated about what actions are expected of it.
I want to thank you for the opportunity to share my
concerns with you and I'd be happy to respond to questions.
[The statement follows:]
Prepared Statement of Dr. Joanne Godley
Chairman Specter, Senator Cochran, Subcommittee Members, thank you
for inviting me to participate in these hearings.
I appreciate the opportunity this subcommittee has afforded me to
testify here today. I want to thank you and your staff for
investigating the issue of our national preparedness for a pandemic of
influenza. Your subcommittee's forward thinking in gathering
information and facts on this issue will serve to identify our national
strengths and also to highlight areas where improvements must be made.
I am honored to be part of this process.
I have the pleasure to serve as the Health Commissioner of
Philadelphia. Philadelphia is a vibrant and active City, recently named
by National Geographic Magazine as ``America's Next Great City.'' We
have a thriving business community and are privileged to have some of
this great country's leading hospitals and medical facilities located
in our city. Our city is a destination for national and international
tourists. In 2004, the Philadelphia airport accommodated 28.5 million
passengers, including 4 million international passengers. Philadelphia
provides services to a diverse urban population, many of whom are
struggling to make ends meet.
Today, I am here to discuss what impact pandemic influenza would
have on Philadelphia and how we can work together to best protect the
health of our citizens and our economy from this threat.
IMPACT OF AN INFLUENZA PANDEMIC ON PHILADELPHIA
Pandemic influenza would have a substantial impact on Philadelphia.
Public health experts estimate that, should pandemic influenza reach
our shores, approximately 35 percent of the population would exhibit
symptoms of the flu. In Philadelphia, with our population of about 1.6
million persons, 560,000 people would fall ill over the 6 months that
the epidemic is likely to last. Our city could also expect to face the
following challenges:
--Hospitals would be overwhelmed: We could see approximately 2,000
inpatient hospital admissions due to influenza during the first
month of the epidemic. Based on an average length of stay of
four days, this means that hospitals would need to cope with
about 8,000 additional patient days during the first month of
the epidemic.
--Healthcare providers would be overwhelmed: During the first month
of an influenza pandemic, doctors and other health care
professionals could expect to see an additional 227,8000
outpatient visits.
--Our mortuary capacity would quickly be overwhelmed. Based on
estimates from the U.S. Centers for Disease Control and
Prevention's (CDC) FluSurge software program, Philadelphia
could expect 2,400 additional deaths during the first six
weeks--amounting to almost 60 additional deaths each day.
Businesses would be impacted not only by the number of ill persons,
but also by the likely need to implement quarantine and containment
measures to limit the spread of the disease. Such measures could
include asking the city's population to stay home--for as long as 10
days.
Despite the estimated large numbers of ill and dead, our city would
have to ensure continuity of its operations. Our city government would
need to continue to function. Our responsibility is to ensure that
essential services are provided to our citizens, such as heating,
transportation, clean water, safe food, and others.
The economic impact of pandemic influenza on the city of
Philadelphia would be substantial. We would suffer from loss of
business revenue, including loss of tourism. Our health care system
would face tremendous expenses. Our city, as would all large cities in
the United States, would be greatly and negatively impacted by an
influenza pandemic.
STEPS PHILADELPHIA IS TAKING TO PREPARE FOR PANDEMIC INFLUENZA
Philadelphia's health department is preparing for pandemic
influenza. We have developed a Pandemic Influenza Preparedness Plan
(with guidance from the Department of Health and Human Services' (DHHS)
plan and information distributed by the CDC and the World Health
Organization (WHO) to help guide our preparations and our response
actions. This plan focuses on key areas:
--Ensuring good surveillance and laboratory capacity, so that we can
rapidly detect the disease and take steps to limit its spread.
Our current surveillance for influenza uses several methods:
outpatient, hospital, laboratory, and mortality-based
approaches;
--Healthcare planning, to cope with the expected surge in patients.
The health department plan includes distributing public stocks
of antiviral drugs and vaccines, providing local physicians and
hospital administrators with updated guidance on clinical
management and infection control;
--Distribution of vaccines and antiviral medications, so that we can
rapidly treat and protect people, with a special attention to
making sure that we can reach the most vulnerable among us.
Last year, Philadelphia was funded as part of CDC's Cities
Readiness Initiative Pilot Program to enhance its ability to
rapidly dispense life saving drugs to our population. At the
conclusion of the pilot, Philadelphia received a 78 percent
increase in its preparedness level. As a test of the Public
Health Emergency Response Plan, Philadelphia Department of
Public Health recently conducted a mass vaccination clinic at a
community health center that provided influenza vaccines to the
elderly. During 2.5 hours, 2,059 doses of influenza and
pneumococcal vaccine were administered to 1,550 people at a
vaccine administration rate of 800 doses per hour;
--Communications, to ensure the mechanisms to communicate our
messages to health care providers and communities during such a
situation;
--Recognition of travel-related risk of disease or importation,
particularly via our busy international airport; and
--Providing psychosocial support to a community that would be in
turmoil.
We will continue working with key partners in critically reviewing
this public health plan so that we can continue to improve our
preparedness to handle an influenza pandemic. Additionally, the mayor
of Philadelphia, John F. Street, has developed an Emergency
Preparedness Review Committee (EPRC) that brings together key
government cabinet members, city leaders (academic, business, and
professional) and national emergency preparedness experts to
strategically analyze the city's hazard risks and evaluate gaps in the
city's various emergency preparedness plans, including the pandemic
influenza preparedness plan. Only by working with our partners at the
local, State, and Federal levels before an event can we best coordinate
our efforts during an event.
SUPPORT NEEDED BY PHILADELPHIA TO COPE WITH PANDEMIC INFLUENZA
Philadelphia is preparing for pandemic influenza, but we need
assistance in several key areas:
--Philadelphia needs a public stockpile of vaccine when it becomes
available. We have the capacity to administer large quantities
of vaccine to our city's population in a timely manner.
However, since the pandemic influenza virus has not yet
appeared, it has not been possible to manufacture a vaccine in
advance. We applaud recent Federal efforts to speed production
capacity of a vaccine, because during a pandemic we would
quickly need a large supply of vaccine to protect our
population. As is true for other large American cities, our
public health planning has identified significant numbers of
residents who are uninsured and underinsured and who would be
less likely to seek health care quickly if they developed
symptoms of influenza. Since the influenza virus would infect
Philadelphians indiscriminately, inability to pay for the
vaccine cannot be a barrier to its administration.
--Philadelphia needs a public stockpile of antiviral medications.
There is a shortage of antiviral medication in this country.
Should pandemic influenza appear, we would need a substantial
supply to protect our citizens.
--Philadelphia needs the ability to augment local health care, both
hospital and outpatient services, and mortuary services. With
the onset of a pandemic, our health care facilities would need
additional medical supplies (such as mechanical ventilators and
N95 respirators) to cope with the tens of thousands of
additional ill people. Development of this surge capacity
requires a substantial investment of resources, preparation,
and cooperation between agencies.
--Philadelphia needs assistance to reduce travel-related importations
of pandemic influenza. The Philadelphia International Airport
must be prepared to screen millions of travelers to identify
those with pandemic influenza. Our airport would benefit from
the establishment of a local Federal/CDC quarantine station to
coordinate this process.
--Philadelphia needs support for the development of a citywide
business continuity plan to ensure no interruption in public
services.
--The establishment of a new laboratory in Philadelphia with the
biologic safety level (III) to handle influenza viral specimens
and that could be certified to be part of the CDC's public
health laboratory network would improve the Philadelphia
Department of Public Health's capacity for rapid identification
of unusual influenza strains. Presently, viral specimens for
laboratory analysis are taken to a State laboratory requires
transport outside of city limits.
--Philadelphia's public health infrastructure needs support. Over the
past five years, there has been a significant attritional loss
of core personnel. The health department lacks capacity to
simultaneously respond effectively to an influenza pandemic and
maintain continuity of health department operations.
Should pandemic influenza become a reality, Philadelphia--and
indeed the Nation and the world--would face substantial challenges. We
need to learn our lessons on prevention from the past--using our
national response to Hurricane Katrina as an example. Working together
and working proactively can better prepare us for pandemic influenza.
I appreciate the opportunity to address this subcommittee and am
ready to answer any questions that you may have at this time.
City of Philadelphia,
Department of Health,
Philadelphia, PA, February 10, 2006.
Hon. Arlen Specter, Chairman,
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies, Committee on Appropriations, U.S. Senate,
Washington, DC.
Dear Senator Specter: Thank you for the opportunity to present
testimony on hearing held by the Committee on Appropriations,
Subcommittee on Labor, Health and Human Services and Education on
Pandemic Influenza Preparedness at Federal, State, and Local Levels on
January 31, 2006. Because of time constraints at end of the hearing, I
agreed to provide information to questions or requests for further
information that were raised during my testimony. I offer the following
additional information concerning the Philadelphia Department of Public
Health:
(1) Provide a delineation of how the Homeland Security monies have
been spent by the Department.
While the Department does not received funding specifically
identified as ``Homeland Security'' funding, a breakdown of funding
from other Federal agencies received by the Philadelphia Department of
Public Health is as follows:
The Department has received 3 types of grants related to
Bioterrorism/Emergency Preparedness:
1. CDC Bioterrorism Awards--funds totaling $4.85 million received
from 2003 to date received, indirectly, through a contract with
Pennsylvania Department of Health. An approximate breakdown of the
expenditures is as follows:
--60 percent was spent on personnel costs, including clinical,
epidemiology, planners, sanitarians, and support persons.
--15 percent was spent on supplies for the City Readiness Initiative
PODs, and related supplies.
--15 percent was spent on technology, including communications
equipment, computers, and contract services.
--10 percent was spent on consultants for trainings, education
materials, and tabletops exercises.
2. HRSA Award--funds provided indirectly through a contract with
Pennsylvania Department of Health: $600,000 one-time grant award for
2004-05. Project involved assessment of hospital surge capacity,
development of a mental health reserve corps, and Medical Reserve Corps
planning project.
3. Congressional ``earmark'' funds, awarded through a direct
contract with CDC: $150,000 one-time award for 2005-06. Project is to
build a web-based public health/medical community communication
interface with security enhancements to all Department of Public Health
networks and data exchange processes.
(2) Provide a delineation of how the Influenza preparedness monies
to be distributed by the States will be spent by the Department of
Public Health.
Although the Philadelphia Department of Public Health does not yet
know what the flu preparedness award amount will be, anticipated
expenditures include:
--Personnel (planning, training, clinical, epidemiology);
--Facility preparations (inspections and improvements related to
quarantine/isolation/morgue);
--Technology (expand immunization registry to capture flu vaccination
info);
--Supplies (respiratory masks, protective equipment); and
--Hospital Support (contracts to support planning efforts, exercises,
preparedness).
(3) Provide a delineation of the additional needs and estimated
costs of the Department that would render Philadelphia pandemic flu-
ready.
The Philadelphia Department of Public Health can identify four
specific needs. The costs associate with them depend on the solution:
--Laboratory.--A local laboratory is needed for surge capacity to
detect novel influenza strains. Cost could be $1-$3 million for
renovation/construction.
--Isolation/Quarantine.--A facility or facilities are needed to house
persons who are not sick enough for hospitalization. Cost could
be up to $5 million to purchase/renovate/prepare facility or
facilities.
--Medications/Vaccines.--Not currently available, but ideally these
items should be stockpiled in preparation. The cost of vaccine
is undetermined. The cost of antiviral medication could be $1.0
million.
--Medical Care surge capacity, especially as it relates to
staffing.--No identified solution at present.
I hope this provides the additional information requested. Should
any additional information be needed, feel free to contact me.
Sincerely,
Joanne Godley, MD, MPH,
Acting Health Commissioner.
Senator Specter. Thank you very much Dr. Godley. The
information has been very helpful in focusing our attention on
where we have to go next. Regrettably we do not have enough
time to ask all the questions here, so I would like to direct
some questions to Dr. Hansen, and Dr. Johnson, Dr. Dixon, and
Dr. Godley for some written responses. We've allocated $350
million, State and local government.
Now I would like to know Dr. Hansen how that squares with
Iowa's needs about 3 million people in Iowa, so that we can
project to other States. Dr. Johnson, with 12 million
Pennsylvanians I'd have the same question.
For Dr. Dixon and Dr. Godley, I'd like to know what you
have done on the flu issue. The pandemic flu issue. What you
have done also on homeland security which may interface as I've
visited Allegheny County Dr. Dixon, I see what you have done on
isolation wards for example. What you need for a county the
size of Allegheny, about 1 million. What you need for
Philadelphia, which is about 1.4 million now and the
surrounding areas. When you talk about a laboratory, I'd like
to know what you need. Thirty-six hours is not adequate, and we
can try to help you on that. When it comes to the
pharmaceutical companies, you gentlemen have focused the issue,
and again I'd like written responses, because of the inadequacy
of time. But tell us more about the memorandum of understanding
as opposed to a contract. What you have to by way of
contractual authority and commitment to--Dr. Abercrombie which
you mentioned.
What you need Mr. Viehbacher when you talk about multi-year
contracting, what will that do for you. Address for us if you
will in writing because we don't have time to probe the
intricacies of limited liability, whether it's adequate now,
and whether it's a hang-up, and what you think is realistic
because you know what the exposure may be. As Senator Harkin
points out the people who will be injured, give us an idea on
your expertise.
Dr. Webby, you said I think that it will happen, were those
your words that the pandemic will happen.
Dr. Webby. I think a pandemic will happen yes.
Senator Specter. You think it will happen?
Dr. Webby. Whether it's H5 or not is the question.
Senator Specter. I know you work with Dr. Robert Webster
who is a world travel, and I want to compliment the switchboard
at your hospital trying to get a hold of him through Hong Kong
I think. Several calls, and have gotten better treatment than
at most switchboards, treated personally to get some insight.
So we'd like to know more from you on the specifics an in
writing as to--what you base your projection on, that it will
happen. When you talk about stage five, what are the
projections. I know this is a judgment call, it can't be
scientific, and what you see in Iraq on the young girl who's in
today's newspaper who has it, and what you see in Vietnam, and
what you see in Turkey. Given the--I hear there are 70 flights
from Istanbul to Hamburg, Germany everyday. So there's a lot of
interaction and a lot of risk factor, and Dr. Webster and your
hospital have been projecting all around the world. From what I
read you have about as good a handle as anybody does in what
you think is going to happen and what we ought to be doing by
way of protecting ourselves. You've heard the limitations to
funding we have. Mr. Barry, you have the best perspective I
think, having written so extensively, and you cite the figure,
when we talked briefly before the hearing about 50 million
could be afflicted. Here again it's a judgment call we don't
want to panic anybody, but we also want to put people on notice
as to what they might have to do to protect themselves, talk
about schools, and public gatherings, and isolating, and the
contagious aspect, how long the pandemic flu stays on objects,
what the water supply is like.
But from your historical perspective, and my red light will
go on, after you started your answer, what do you think. How
likely are we to find something which comes near 1918?
Dr. Barry. Well as Dr. Webby said, nobody can predict what
virus is going to jump species. However, it seems almost
inevitable from everything we know scientifically, that some
virus will jump species. When that happens, we don't know. I
mean, it could have already happened, and we don't know about
it. It might not happen for 20 years. It's almost a random
event. But we do know as far back as we can look in history the
longest gap between pandemics is 42 years. And we're now at 37
years and counting.
Senator Specter. Thank you very much, Senator Harkin.
Senator Harkin. Again I just join with Senator Specter in
thanking you all very much for your excellent testimony and I
read most of it last night. We're under a time constraint right
now, but just about three things I want to cover. Again I want
to just repeat for emphasis sake. That and perhaps if I can't
get the answer here from the manufacturers, maybe in writing,
about this demand poll.
Mr. Barry you mentioned it. As I said, I have this bill S.
2112. I want you to take a look at it. Maybe it's not perfect,
nothing's every perfect around here. But the idea was to
provide for a free flu shot for every single American. Now if
we did that, as I said I think it would create demand and
therefore we hope that flu manufacturers would build
manufacturing capacities. It would stimulate that production
facility, it would lower the cost of the flu shot dramatically.
It would stimulate public health agencies to build sustainable
delivery systems. Now if we're going to face a pandemic, we
can't just have people lining up to go to the local public
health office someplace to get shots. They're going to have to
get it at Wal-Mart, Target, at sports games, at churches on
Sunday, or whatever day people go to church, or synagogues.
There's going to have to be numerous places. We're going to
have to create that system. I mean you can't just ask someone
here, go out and give shots. They have to be trained. They have
to be supervised. You have to build that system. So if we have
that in place to give a free flu shot to every American, every
year, we could have that system in place.
It would also provide protection from annual flu. Lost
lives 36,000--200,000 hospitalizations. Think of the money that
we would just save from all the hospitalizations every year. As
I said, and I'm on a little thin ice on this, but I've checked
with some scientists that there may be some measure of immunity
built up from this, for a possible pandemic flu that might
come. So I hope that you will take a look at that and let me
know what you think about that.
Second, Dr. Dixon, on regional labs, I'm shocked when I
heard Senator Stevens say that they don't have that in Alaska.
Now Pennsylvania, east, west, go to Philadelphia, I can't--I
don't know how long that takes, but my gosh, Alaska is way in
the heck out there, and they ought to have that capability. So
you've raised a question of regional labs. I think we ought to
look at that. How many we need, where they ought to be located,
I don't know.
Dr. Dixon. We need to have a plan though, so that we have
them strategically located throughout this country.
Senator Harkin. We need some type of regional labs. I
believe that. I just don't know exactly what the structure
would look like. But certainly we need to address what Senator
Stevens asks. Because it actually may start, Senator Stevens,
in your State, it may start with those birds and stuff coming
across that flyway. It could actually start in his State, and
if we're talking about immediate isolation, and coverage and
stuff, that may be the first place where we have to address it
nationwide. For our Nation. So I thank you for bringing that
up.
Dr. Abercrombie, you mentioned that HHS revised their
request for courses, now $46 million for this fiscal year. That
$18 million will be HHS and $28 million will be the States. Dr.
Hansen, here's what you said: ``I would ask that you carefully
review the expectations of States to independently purchase
antivirals. Not only are the costs staggering, and an
unrealistic expectation, but the level of protection our
citizens receive should be standardized across the country.
There must be a national commitment for antiviral purchase and
stockpiling.''
Again I raise the question, Dr. Abercrombie, if we're
asking the States to pick up 75 percent, that would be $28
million, what happens in a State like Louisiana? They don't
have any money, or Mississippi, they don't have any money.
They've been answering--in Florida they've been answering the
costs of Hurricane Katrina and stuff, they don't have any
money. Shouldn't we focus--and shouldn't we, if we have a
stockpile, shouldn't we be able to focus where the outbreak
occurs to get the antivirals out there immediately?
Now what happens if we have State stockpiles? Let's say
Pennsylvania, let's say they come forward, they're rich. They
got a lot of money, they come in, they build a stockpile; we
don't have that much in Iowa. If the outbreak occurs in Iowa,
will Pennsylvania send its antiviral--would it send its Tamiflu
to Iowa. Of course not. Their Governors are going to want to
protect their own States. So you'll have all these States
stockpiling, the outbreak that occurs in Louisiana where they
don't have any money, are we going to send--will the States
step forward, and say we'll just send them out. The citizens of
that State will say, wait a minute, we paid for this, we got to
keep them here. That's why I think it's got to be a national
type of a stockpile.
Dr. Abercrombie, I hate to put you on the spot, but could
you just address yourself again to that. About the $18 million
HHS, and $28 million States. Just from your expertise, is that
the proper way to proceed. Or should we do it on a national
basis?
Dr. Abercrombie. Well, first of all, I think the first
step, Senator, is to commit to purchasing enough to cover a
significant portion of the U.S. population. The HHS plan calls
for enough for 25 percent of the population.
Senator Harkin. Is that enough?
Dr. Abercrombie. Well, we're not public health experts, but
if you listen to the World Health Organization, they advocate
stockpiling for 25 percent. Countries in Europe are
stockpiling, for between 20 and 40 percent. The Infectious
Disease Society of America advocates 50 percent. So certainly
25 percent is in that range. So once the right amount is
ordered, clearly we will work with HHS to make sure it is
delivered, distributed to the right point. We are not
distribution experts. We manufacture and sell, and discover and
research medicines. We have been working with HHS, and in fact
recently had a discussion with Secretary Leavitt to help
coordinate State purchases to ensure that States can benefit
from the cost sharing proposed in the pandemic plan from the
President.
Senator Harkin. Well, I still question if this is even--
one, if this is the right way to proceed. Second, if the States
have the money to purchase it, what do we do about a Louisiana
that simply won't have the money? I just don't know what we do
in that case.
Last, on the issue of adjuvants, and moving ahead with
adjuvants. All the briefings I've had indicate that this is
something that we ought to pursue very aggressively. In terms
of making sure that our stockpile will be--will be expanded and
used more. Can you address yourself again, Dr. Soland, to the
issue of the adjuvants.
Dr. Soland. Sure. Through the work that we started back in
1997, what we've found is that adjuvants are antigen-sparing,
or it spares the amount of vaccine or is spares the amount of
vaccine that is necessary in order to protect an individual. So
that in theory from this last study that was conducted with the
NIAID on a H9N2 virus, it was suggested that you could use one-
fourth of the normal antigen with adjuvant and have them
protected.
That's the first part. The second part is that the adjuvant
seems to offer additional protection as the virus changes or
drifts, that you would get a sort of cross protection that
might allow for protection as the virus continues to drift. So
those are the two potential benefits of adjuvants.
Senator Harkin. Do you feel that NIH is moving ahead
aggressively enough on adjuvants?
Dr. Soland. Both the NIH and the FDA have been very helpful
in this regard, and as I mentioned both in the written and oral
testimony that we're undertaking the next trial with an H5N1,
with our novel adjuvant that we'll be starting relatively soon.
Senator Harkin. Mr. Viehbacher, what do you think about a
free flu shot for every American?
Mr. Viehbacher. I certainly support the notion that we want
to have broad based vaccination because as you say, that would
encourage the production capacity of seasonal flu. That
capacity could then be used if you needed to produce pandemic.
Whether or not you want to pay for every American to have a $15
to $20 shot, I mean I would submit that there's no more cost
effective healthcare intervention than a flu shot. I mean save
the valuable Government resources for those who can't afford
it. That's really I think the question up for Government, I
think the sense of having a broader based vaccination is a good
one.
Senator Harkin. I've heard that if we did that, that the
cost of the flu shot might even come down to less than $5,
simply because of the massive production that would be caused,
does that--I don't know, do you have any idea--you probably
don't have any idea.
Mr. Viehbacher. I couldn't answer that question. It's
speculative.
Senator Harkin. I see. Thank you.
Senator Specter. Thank you Senator Harkin, Senator Stevens.
Senator Stevens. Well Mr. Chairman, I don't know about
questions this late in the day here, but I don't think we have
enough of a sense of urgency. I don't know if you heard about
the fact that in Nome last year, a body of an Eskimo woman who
died in 1918 was disinterred and tested and we were told it was
a similar--the cause of her death was similar to the virus that
has the world worried right now. Now, the birds that come
across the Pacific, our Eskimo and Native people rely on them
for food. They intersect with the flyways that affect the whole
Nation in terms of the contact of those birds throughout our
enormous State. I just think that when we look at the degree of
preparation we've had right now to face a similar circumstance,
it's just grossly inadequate. I'm sad that we didn't put up the
$7.1 billion last year; I hope we get the balance of it this
year. But I'm worried about the allocation of that money, I
know that there's a great demand from every city and every
State for Federal money to meet the necessities of each one of
those localities, but I don't hear really much coming from the
States, and localities who have their own money yet. I don't
think it's something that the Federal taxpayer can finance all
of it. I think we ought to finance the basic infrastructure, as
many people have mentioned, to get the vaccines and the viral
out to all our people. But it is a difficult thing for me right
now to see that come about, all of you have talked about
cooperation, integration, and basic infrastructure here. My
hope is that Mr. Barry's going to write another book. Because I
think his last one got the attention of the public and we need
even more. You need to be a greater Paul Revere, my friend. I
think we're more excited about this here in Washington than the
rest of the country, is what I'm saying. I do hope we can find
some way, beyond trying to get the money, to get the public
aware of the threat that may face this country. I'm just at a
loss for the answers, except that we should find some way to
get a greater emphasis on everything all of you have mentioned.
I can't believe we can find Federal money to do everything
you've asked.
Senator Specter. Well, thank you very much, Senator
Stevens. I agree about the necessity for more attention from
the country, and I think we have spent more attention here
because the President had this special speech on November 1 and
we had a hearing and we've appropriated a lot of money, and we
have to see whether it is adequate. I think we caught the
attention of the Federal agencies and the authorities today,
and very illuminating to hear what Mr. Barry and Dr. Webby say
about the urgency of the problem and what's happening with the
pharmaceutical companies, and what's happening at the State and
local level. Including your answers, Dr. Hansen and Dr.
Johnson, what your Governors are going to do, and your Senators
will help your Governors, but Senator Stevens raises a valid
issue, what it's going to take for Pennsylvania with 12 million
and what it's going to take for Iowa with 3 million people and
then we can project it further. This is a continuation of what
we're going to be doing, but there will be more coming out of
this subcommittee and the full committee and the Congress.
STATEMENT FROM SENATOR LARRY CRAIG
We have received the prepared statement of Senator Larry
Craig which will be made part of the hearing record.
[The statement follows:]
Prepared Statement of Senator Larry Craig
Thank you, Mr. Chairman. I appreciate you convening this hearing
today. It is of utmost importance that we fully asses our level of
preparedness for an avian flu pandemic.
Last Congress, while I was Chairman of the Special Committee on
Aging, we held hearings to address an impending shortage of seasonal
influenza vaccine--which was compounded by the uncertain market demand
and liability concerns faced by vaccine manufacturers.
Now, these concerns are resurfacing as we encounter the threat of
pandemic flu. In addition to underscoring our need for a stable vaccine
supply, the possibility of pandemic flu ushers in a new set of serious
considerations. It forces us to confront such realities as staggering
mortality rates and workforce shortages--translating into a devastating
economic impact in the hundreds of billions of dollars.
Avian flu has been characterized as both an ``urgent'' and
``uncertain'' threat. We do not know where or when an outbreak will
strike, but consensus is growing among disease experts that it is an
all-too-likely outcome over the next few years.
However, compared with the three flu pandemics that occurred last
century, we are much better equipped to ward off a full-fledged
pandemic. Unlike in previous years, we now have the scientific
capability to provide advance warning of an impending outbreak. Many
public health experts claim that by emphasizing surveillance and
preparedness--and effectively distributing our supply of vaccines and
antivirals--we have the potential to minimize and contain an outbreak
in the event one does occur.
This presents a tremendous challenge. We must strive for the
seamless coordination of preparedness and response efforts at the
local, State, and national levels. Doing so will not only maximize the
funds appropriated for avian flu relief, but will also help us to save
precious time if the pandemic threat becomes a reality.
That is why today's hearing is so vital and so timely--it is
focusing our efforts exactly where they need to be. I hope that we can
capitalize on this opportunity to have local, State, and Federal health
officials all under one roof--along with a diverse set of industry
perspectives.
With that, I want to extend a welcome to the witnesses who are here
today. I look forward to hearing your testimony.
CONCLUSION OF HEARING
Senator Specter. Thank you all very much, and that
concludes our hearing.
[Whereupon, at 10:21 a.m., Tuesday, January 31, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]