[Senate Hearing 109-740]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 109-740
 
                    PANDEMIC INFLUENZA PREPAREDNESS

=======================================================================

                                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

                               __________

         Printed for the use of the Committee on Appropriations


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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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
                                 ------                                

 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

                              ----------                              
                                                                   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

                              ----------                              


                       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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\ 
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
             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.
---------------------------------------------------------------------------
    \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.).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \11\ NISN Statement on antiviral resistance in influenza viruses. 
Weekly Epidemiological Record (2004); 33, 308-308.
---------------------------------------------------------------------------
             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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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.]

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