[House Hearing, 109 Congress]
[From the U.S. Government Printing Office]




                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION


                             JUNE 30, 2005


                           Serial No. 109-49


       Printed for the use of the Committee on Government Reform

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


22-808                      WASHINGTON : 2005
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                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
JON C. PORTER, Nevada                BRIAN HIGGINS, New York
KENNY MARCHANT, Texas                ELEANOR HOLMES NORTON, District of 
LYNN A. WESTMORELAND, Georgia            Columbia
PATRICK T. McHENRY, North Carolina               ------
CHARLES W. DENT, Pennsylvania        BERNARD SANDERS, Vermont 
VIRGINIA FOXX, North Carolina            (Independent)
------ ------

                    Melissa Wojciak, Staff Director
       David Marin, Deputy Staff Director/Communications Director
                      Rob Borden, Parliamentarian
                       Teresa Austin, Chief Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel

                            C O N T E N T S

Hearing held on June 30, 2005....................................     1
Statement of:
    Crosse, Dr. Marcia, Director, Health Care Issues, U.S. 
      Government Accountability Office; Mary C. Selecky, 
      Washington State Secretary of Health, testifying on behalf 
      of the Association of State and Territorial Health 
      Officials; Dr. Shelley A. Hearne, executive director, Trust 
      for America's Health; Dr. John F. Milligan, executive vice 
      president and chief financial officer, Gilead Sciences, 
      Inc.; and George B. Abercrombie, president and chief 
      executive officer, Hoffman-La Roche, Inc., accompanied by 
      Dr. Dominick Iacuzio, medical director, Roche Laboratories, 
      Inc........................................................   104
        Abercrombie, George B....................................   156
        Crosse, Dr. Marcia.......................................   104
        Hearne, Dr. Shelley A....................................   133
        Milligan, Dr. John F.....................................   143
        Selecky, Mary C..........................................   126
    Leduc, Dr. James W., Director, Division of Viral and 
      Rickettsial Diseases, National Center for Infectious 
      Diseases, Centers for Disease Control and Prevention; Dr. 
      Anthony Fauci, Director, National Institute of Allergy and 
      Infectious Diseases, National Institutes of Health; Dr. 
      Bruce Gellin, the Director of the National Vaccine Planning 
      Office, Department of Health and Human Services............    26
        Fauci, Dr. Anthony.......................................    43
        Gellin, Dr. Bruce........................................    66
        Leduc, Dr. James W.......................................    26
Letters, statements, etc., submitted for the record by:
    Abercrombie, George B., president and chief executive 
      officer, Hoffman-La Roche, Inc., prepared statement of.....   158
    Burton, Hon. Dan, a Representative in Congress from the State 
      of Indiana, prepared statement of..........................   176
    Crosse, Dr. Marcia, Director, Health Care Issues, U.S. 
      Government Accountability Office, prepared statement of....   107
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland:
    Article dated June 12, 2005..................................    14
    Prepared statement of........................................    22
    Davis, Chairman Tom, a Representative in Congress from the 
      State of Virginia, prepared statement of...................     4
    Fauci, Dr. Anthony, Director, National Institute of Allergy 
      and Infectious Diseases, National Institutes of Health, 
      prepared statement of......................................    45
    Gellin, Dr. Bruce, the Director of the National Vaccine 
      Planning Office, Department of Health and Human Services, 
      prepared statement of......................................    69
    Hearne, Dr. Shelley A., executive director, Trust for 
      America's Health, prepared statement of....................   136
    Leduc, Dr. James W., Director, Division of Viral and 
      Rickettsial Diseases, National Center for Infectious 
      Diseases, Centers for Disease Control and Prevention, 
      prepared statement of......................................    28
    Milligan, Dr. John F., executive vice president and chief 
      financial officer, Gilead Sciences, Inc., prepared 
      statement of...............................................   146
    Porter, Hon. Jon C., a Representative in Congress from the 
      State of Nevada, prepared statement of.....................   177
    Selecky, Mary C., Washington State Secretary of Health, 
      testifying on behalf of the Association of State and 
      Territorial Health Officials, prepared statement of........   128
    Watson, Hon. Diane E., a Representative in Congress from the 
      State of California, prepared statement of.................   178
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of.................     8



                        THURSDAY, JUNE 30, 2005

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:05 a.m., in 
room 2154, Rayburn House Office Building, Hon. Tom Davis 
(chairman of the committee) presiding.
    Present: Representatives Davis, Shays, Burton, Gutknecht, 
Dent, Waxman, Maloney, Cummings, Kucinich, Clay, Watson, and 
    Staff present: Melissa Wojciak, staff director; David 
Marin, deputy staff director/communications director; Keith 
Ausbrook, chief counsel; Robert Borden, counsel/
parliamentarian; Rob White, press secretary; Drew Crockett, 
deputy director of communications; Susie Schulte, professional 
staff member; Teresa Austin, chief clerk; Sarah D'Orsie, deputy 
clerk; Kristina Sherry, legislative assistant; Leneal Scott, 
computer systems manager; Phil Barnett, minority staff 
director/chief counsel; Karen Lightfoot, minority 
communications director/senior policy advisor; Naomi Seller, 
minority counsel; Josh Sharfstein, minority health policy 
advisor; Earley Green, minority chief clerk; and Jean Gosa, 
minority assistant clerk.
    Chairman Tom Davis. Good morning. The committee will come 
to order.
    I want to welcome everybody to today's oversight hearing to 
evaluate the U.S.' ability to respond to the threat of a global 
influenza pandemic. This is the committee's fifth hearing over 
the past 2 years on issues surrounding influenza and our public 
health system's preparedness levels.
    The past few annual influenza seasons, as well as the 
recent spread of avian flu across Asia, have raised the urgent 
question of whether the United States is prepared to deal with 
the threat of a flu pandemic. Today, we will assess our public 
health system's response capabilities at the Federal, State and 
local levels and determine what additional measures are needed 
in order to improve preparations and reduce the risks imposed 
by an avian flu outbreak.
    The experts tell us the next flu pandemic is a matter of 
when, not if. No one knows exactly when it might strike or 
whether the next worldwide pandemic will be a version of the 
avian flu, which you will hear today referred to as H5N1 or 
``avian influenza A,'' or a different influenza strain.
    What is not up for debate is what the stakes are in 
dollars, resources and human lives. They are enormous. 
According to experts, the next pandemic would be worse than the 
Spanish flu, which is estimated to have caused the deaths of 40 
million to 50 million people worldwide in 1918 and 1919. Given 
the global integration of today's economic markets and the 
capacity for rapid travel from one corner of the globe to 
another, a pandemic would move around the world in the same 
amount of time it takes to fly from New York to Tokyo.
    This occurred in the case of the SARS outbreak 2 years ago. 
In the estimation of several international scientists, 
including U.S. public health officials, a flu pandemic is the 
largest public health threat facing the world today. Flu 
pandemics generally occur three to four times per century when 
novel flu strains emerge and are readily transmitted from 
person to person. There is a strong feeling among the public 
health officials that the next one is imminent.
    Today, we will examine what actions and planning procedures 
have been and still need to be taken at Federal, State and 
local levels to adequately handle a global communicable disease 
outbreak. Early detection of new strains and the rapid 
development of effective vaccines are important keys to 
protecting the public against the flu and anticipating 
potential outbreaks.
    The World Health Organization, the Center for Disease 
Control Prevention and other public health organizations have 
been conducting surveillances in Asia, where H5N1 is now 
circulating and to date has infected and killed more than 50 
people in Vietnam, Cambodia and Thailand. The H5N1 flu strain 
is extremely virulent and most humans lack immunity.
    Why is this surveillance so important? As we have heard in 
previous testimony before this committee, flu vaccines become 
obsolete following each season and require constant 
reformulation. Once the next pandemic flu strain has been 
identified, a vaccine would take at least 4 months to produce. 
Furthermore, only a few countries have flu vaccine production 
facilities, and the United States is home to just one of them. 
Anti-viral medications, which could help alleviate symptoms of 
those who contract the pandemic flu virus and help reduce 
mortality levels are considered a strong first line of defense 
until a vaccine can be produced and administered.
    But the United States has only contracted for or stockpiled 
in its strategic national stockpile enough courses of the anti-
viral Tamiflu to cover 5.3 million people, significantly short 
of the World Health Organization's guideline of 25 percent of 
the population. So let's do the math. We are about 62 million 
under the WHO guidelines, and we can cover 5.3 million today.
    These statistics are disconcerting and we will be asking 
our government witnesses today if we should be doing more to 
protect Americans against the threat of avian flu. I understand 
some of our witnesses this morning will express concerns about 
our preparedness levels and Federal funding for States and 
    I look forward to constructive dialog regarding those 
concerns. I know we all share the same goal at the end of the 
day: a public health system that is adequately prepared and 
equipped to deal with an outbreak of a deadly and contagious 
disease. We must not only be preparing for the likely course of 
events, but we have to be expecting and be able to adjust to 
the unexpected.
    [The prepared statement of Chairman Tom Davis follows:]

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    Chairman Tom Davis. We have a great selection of witnesses 
to provide testimony this morning. Dr. James LeDuc, Dr. Anthony 
Fauci, and Dr. Bruce Gellin from the Department of Health and 
Human Services will discuss the efforts being taken at the 
Federal level to plan and prepare for a flu pandemic. They will 
also describe preparedness coordination efforts with State and 
local authorities.
    Joining us on our second panel will be Dr. Marcia Crosse of 
GAO who will discuss lessons learned from previous annual flu 
seasons that can be applied to pandemic preparedness. Ms. Mary 
Selecky, the Washington State Secretary of Health, will be 
testifying today on behalf of the Association of State and 
Territorial Health Officials, to provide an assessment of State 
and local public health departments' ability to respond 
adequately to a full pandemic.
    Dr. Shelley Hearne, executive director of Trust for 
America's Health, which recently produced a noteworthy report, 
will provide an assessment of improvements to the public health 
system's remaining vulnerabilities. We have also invited the 
two companies who partnered together to research and develop 
the anti-viral Tamiflu, Gilead Sciences, Inc. and Hoffman-La 
Roche, to discuss anti-viral production and capacities and 
pandemic planning.
    Dr. John Milligan, executive vice president and CFO of 
Gilead and Mr. George Abercrombie, president and CEO of 
Hoffman-La Roche will be joining us to discuss a recent dispute 
over the Tamiflu license and what impact, if any, it might have 
on pandemic preparedness.
    We welcome all the witnesses today and their testimony.
    I would now recognize the distinguished ranking member, Mr. 
Waxman, for his opening statement.
    Mr. Waxman. Thank you, Mr. Chairman.
    Today's hearing comes at a time of high alert for the 
public health system. Eight years ago, a lethal strain of 
influenza skipped from chickens to humans and led to multiple 
deaths in Hong Kong. The virus has continued to mutate and has 
become arguably the most serious imminent threat to human 
health in the world.
    From chickens in Hong Kong, the avian flu virus now infects 
waterfowl species in 10 Asian countries. It infects ducks, 
domestic cats and even wild tigers. Increasingly, it has 
skipped the species barriers into humans. Over the last 18 
months, more than 100 people have been diagnosed with avian flu 
in Vietnam, Thailand and Cambodia. Over half have died.
    According to experts in infectious disease, this virus may 
be only a few mutations away from becoming highly contagious 
and triggering a global public health crisis. This hearing asks 
a simple question: Are we ready? Unfortunately, we are going to 
hear the answer: We are not. Our pandemic flu plan is still in 
draft form. A vaccine against pandemic flu will take months to 
produce and the global capacity to make such a vaccine falls 
far short of what is needed. We have a fraction of the anti-
viral medication we will need to respond to a pandemic, and our 
public health system is underfunded and straining.
    Last year's flu vaccine shortage exposed confusion and 
inefficiency in the delivery of key drugs. We have no stockpile 
of routinely recommended childhood vaccines. There are major 
shortages of qualified personnel around the country. If a 
global pandemic were to start tomorrow, our country and the 
world would be in serious danger. According to experts, as many 
as 500,000 Americans could die.
    It is unlikely the pandemic will start tomorrow. We are now 
in the window between the sounding of the alarm bells and the 
start of an outbreak, so we need to act quickly. A key priority 
is to finish the pandemic plan. This plan needs to be specific 
enough so that the Federal Government, States, localities, 
businesses and private citizens are ready to step into their 
roles immediately.
    A second priority is to mend the gaps in our public health 
system. We must ensure that our local and State public health 
departments have the resources to conduct surveillance, 
organize a local response, and distribute scarce vaccines and 
anti-viral medications. It is appalling that the administration 
is proposing to cut support for these activities by $130 
million this next year. We must ensure that key vaccines for 
children are stockpiled so we are prepared if production lines 
are needed to make a pandemic flu vaccine. We must invest in 
public health training and infrastructure.
    A third priority is to develop the vaccine to make a 
vaccine quickly and in large amounts. This is a major 
scientific challenge that will require significant resources. 
So far, we have spent $4 billion to prepare for a smallpox 
attack, which is very unlikely, and an anthrax attack which 
would likely be contained geographically. We have not yet made 
this type of investment in effort to counter an imminent and 
catastrophic strain of influenza.
    A fourth priority is to stockpile anti-viral medications. 
Today, we will hear from two companies responsible for the drug 
Tamiflu, which is the only therapy that is believed to be 
effective against avian flu. These companies are fighting about 
who has the right to make the drug. I expect that they will 
hear a bipartisan message today not to let their dispute 
interfere with the drug's supply.
    The biggest obstacle we have is complacency. For years, 
public health experts warned the Department of Health and Human 
Services that it needed a better plan to address the fragility 
of our vaccine supply, and for years we have heard reassuring 
platitudes from officials about how everything possible was 
being done. Yet when we had an actual flu vaccine shortage last 
year, we learned the truth. The executive branch was caught 
flat-footed because warning after warning had been ignored.
    We need to have a zero tolerance policy for complacency. We 
need to demand action, not empty promises. Being prepared for 
pandemic flu is not a Republican or Democratic issue. We need 
to join together to direct both more attention and more 
financial resources to this serious threat.
    I thank the witnesses for coming and I look forward to 
their testimony.
    Thank you, Mr. Chairman.
    [The prepared statement of Hon. Henry A. Waxman follows:]

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    Chairman Tom Davis. Thank you very much, Mr. Waxman.
    Mr. Shays.
    Mr. Shays. Thank you, Mr. Chairman. Mr. Chairman, thank you 
for holding this hearing.
    I would just say to our witnesses that we are very grateful 
for the work that they do. I have had a number of visits to the 
World Health Organization. I think it is one of the world's 
treasures. They are unbelievable. I just appreciate as well the 
work that we do in this country.
    I would just end by saying that flu is a tremendous 
practice for biological terror. If we are ready for the flu, we 
are practically ready for anything. Mother nature gives us this 
practice, and we should take advantage of it on that level, but 
obviously most importantly to save lives.
    So it is great that we are doing this hearing, and I thank 
    Chairman Tom Davis. Thank you very much.
    Any other opening statements? Mr. Gutknecht.
    Mr. Gutknecht. Just real briefly. Again, thank you, Mr. 
Chairman, for holding this hearing. I think on behalf of all 
Americans who are learning more about the potential of this 
pandemic, we want to make certain that we at the Federal level 
and NIH and others are doing all we can to not only prevent it, 
but to come up with potential solutions.
    So again thanks for this hearing.
    Chairman Tom Davis. Thank you very much.
    Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman. I thank 
you for holding this critically important hearing to evaluate 
our Nation's preparedness to respond to pandemic influenza.
    The Chiron Corp.'s inability to supply the United States 
with the flu vaccine we anticipated for the 2004-2005 flu 
season exposed the fragility of our Nation's vaccine supply. 
This colossal failure to get it right last flu season raised 
some serious questions about our Nation's preparedness to 
lessen the impact of a more destructive strain of the flu that 
could trigger a global pandemic.
    Avian flu is considered increasingly likely to cause a 
pandemic. Experts estimate that a pandemic will result in the 
deaths of over 500,000 Americans and infect 25 percent of the 
world's population. The Baltimore Sun on June 12, 2004 reported 
in an article entitled Fears of Flu Pandemic Spearheading 
Preparations, ``The threat of an avian flu pandemic from Asia 
could cause 12,000 deaths in the State of Maryland early on, 
with the possibility of many more later.''
    The article continues by noting that, ``More conservative 
estimates from the U.S. Centers for Disease Control and 
Prevention suggest 1,600 to 3,700 Maryland deaths and 16,000 
hospitalizations.'' Mr. Chairman, I ask that this article be 
included into the record.
    [The information referred to follows:]

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    Mr. Cummings. One need not be an expert to comprehend the 
magnitude of this loss of life and the disastrous impact a flu 
pandemic would cause to our economy and to our society. With 
this in mind, we must agree to move forward in the best 
interests of the Nation and achieve our ultimate objective of 
ensuring that our Nation is capable of effectively and 
efficiently addressing a flu pandemic. This begins with having 
a plan, one that covers intergovernmental coordination, the use 
of the strategic national stockpile, and a process for 
distributing anti-virals and vaccines.
    While the administration took a step in the right direction 
when it released the draft pandemic flu plan, this plan is 
unfortunately silent on critical details and is not yet 
finalized. How the vaccines will be distributed, purchased, 
prioritized, and what information will be conveyed to the 
public remain unresolved.
    In light of the fact that State and local health 
departments will function on the frontlines of a flu pandemic, 
I am deeply troubled that the administration proposed 
undermining State and local preparedness by cutting $130 
million in Federal support of those efforts in fiscal year 
2006, with the World Health Organization stating: ``Everything 
suggests that the situation we are in now, there is a greater 
risk for a pandemic than for many decades.'' We should increase 
Federal funding of our public health infrastructure instead of 
attempting to restore fiscal sanity to the detriment of public 
health and safety.
    It is also critically important to our Nation's readiness 
that we have adequate supplies of vaccines and anti-virals. 
While vaccines are considered effective, they are difficult and 
slow to produce. Regrettably, apparent global capacity to make 
a flu vaccine will potentially leave billions of people in need 
during a pandemic.
    Equally disturbing is the fact that the United States is 
particularly vulnerable to a shortage due to limited vaccine 
manufacturing facilities in the United States. While the 
Federal Government works to improve our Nation's access to a 
safe, affordable and effective flu vaccine, it seems prudent 
that we also obtain anti-viral drugs deemed effective against 
pandemic flu. It should be noted while the World Health 
Organization recommends that countries purchase enough of an 
anti-viral drug called Tamiflu to treat 25 percent of their 
population, the United States only has enough of this drug to 
treat 2 percent of the population.
    With last year's flu season fresh in mind, we must ensure 
that no Americans needlessly suffer or die due to poor 
preparedness. Our Nation must be ready to safeguard our 
citizens by providing them with either the proper treatment or 
means to prevent infection in the event of an outbreak. Any 
less would be a gross abdication of our responsibility to 
protect citizens from threats both seen and unseen.
    I yield the balance of my time and I thank you.
    [The prepared statement of Hon. Elijah E. Cummings 





    Chairman Tom Davis. Thank you very much.
    Members will have 7 days to submit opening statements for 
the record. We will now recognize our first panel: Dr. James 
LeDuc, the Director, Division of Viral and Rickettsial 
Diseases, National Center for Infectious Diseases at the Center 
for Disease Control and Prevention; Dr. Anthony Fauci, 
Director, National Institute of Allergy and Infectious 
Diseases, National Institutes of Health; and Dr. Bruce Gellin, 
the Director of the National Vaccine Planning Office, 
Department of Health and Human Services.
    As you know, it is the policy of this committee, we swear 
all witnesses in, so if you would rise and raise your right 
    [Witnesses sworn.]
    Chairman Tom Davis. Thank you. Be seated.
    Dr. LeDuc, we will start with you and we will move straight 
down. Thank you very much.



    Dr. LeDuc. Thank you very much, Mr. Chairman and members of 
the committee.
    I would like to share with you some of the advances that we 
have made on global surveillance. I will leave comments to the 
issues surrounding anti-viral drug development and vaccine 
development to my colleagues Dr. Fauci and Dr. Gellin.
    Let me begin with a brief summary of the current situation 
in Asia. As of yesterday, June 28th, the World Health 
Organization had reported 108 cases of avian influenza in 
humans since January 28, 2004, with a case fatality rate of 
about 50 percent. The World Organization for Animal Health, the 
OIE, had confirmed H5N1 influenza infections in animals in nine 
Asian countries during 2004 and 2005, with especially severe 
outbreaks in Vietnam and Thailand. Although the situation is 
very serious, there remains no evidence for sustained human-to-
human transmission.
    We continue to work very closely with the World Health 
Organization to monitor the situation and indeed the Chief of 
our influenza branch, Dr. Nancy Cox, is en route back from 
Vietnam even as we speak, having just completed a mission to 
Hanoi as part of a WHO team to investigate a cluster of human 
cases of influenza.
    CDC is working closely with health officials in the region 
to strengthen influenza surveillance capacity. In the last 
fiscal year, the department provided $5.5 million to WHO and 
countries of the region to establish or improve their national 
influenza centers and to strengthen the WHO global network of 
collaborating laboratories. The goal of these investments is to 
ensure the earliest possible recognition of strains with 
pandemic potential to make certain that the viruses are 
isolated and made available to the global community for vaccine 
development, and to assist countries in local control of 
efforts to prevent widespread transmission.
    As part of these efforts, CDC staff are being assigned to 
the WHO office in Geneva and the regional office in Manila and 
in the country office in Vietnam. These investments are being 
leveraged through collaborations with the U.S. Navy 
laboratories in Indonesia and in Cairo, Egypt and with the CDC 
International Emerging Infections Program in Bangkok, Thailand. 
The fiscal year 2005 funding for this effort is $7.2 million. 
Recently, Congress passed and the President signed a fiscal 
year 2005 emergency supplemental appropriation which included 
$25 million in assistance to prevent and control the spread of 
avian influenza in Southeast Asia. These funds will further 
support development of improved disease surveillance, training 
of laboratory and medical staff, preparedness activities, and 
enhanced communication capabilities.
    Here in the United States, we are training laboratory staff 
in all 50 States to ensure their ability to diagnose avian 
influenza should it arise. We are expanding our network of 
sentinel physicians to more accurately monitor the spread of 
influenza during the flu seasons. CDC has also taken the lead 
in revising the department's pandemic preparedness plan. The 
revision, which is scheduled for release later this summer, 
will be significantly expanded and will provide comprehensive 
guidance to our partners in State and local health departments. 
The plan is being developed in cooperation with the Advisory 
Committee on Immunization Practices and the National Vaccine 
Advisory Committee, and will offer guidance on prioritization 
for use of both anti-viral drugs and vaccines.
    Finally, CDC is leveraging investments already made in 
bioterrorism preparedness to ensure that these resources that 
are already part of the strategic national stockpile are 
included in our pandemic planning. Mass casualty and surge 
capacity planning for hospitals is also underway in conjunction 
with HRSA.
    Health and Human Services Secretary Mike Leavitt has made 
influenza pandemic planning and preparedness a top priority and 
has chartered the Influenza Preparedness Task Force to prepare 
the United States for this potential threat to the health of 
our Nation. As a member of this task force, CDC is proud to 
undertake these activities with our partners both domestically 
and globally.
    Thank you for the opportunity to share this information 
with you. I would be happy to answer any questions.
    [The prepared statement of Dr. LeDuc follows:]

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    Chairman Tom Davis. Thank you.
    Dr. Fauci.


    Dr. Fauci. Thank you very much, Mr. Chairman and members of 
the committee, for allowing me to discuss with you this morning 
the role of the NIH research endeavor in the ultimate 
development of countermeasures against pandemic flu in the form 
of diagnostics, therapeutics and vaccines.
    Very briefly to put this into perspective, this slide here 
on your left shows the complementary roles within the 
Department of Health and Human Services. You have just heard 
from Dr. LeDuc about the CDC's role in surveillance, detection, 
disease control and prevention. The NIH, as I will outline 
briefly for you, conducts basic and clinical research 
ultimately to develop vaccines and therapeutics. There is an 
important role for the FDA in the regulatory process of the 
approval of these products. This is all coordinated under the 
Office of Public Health Emergency Preparedness.
    Next slide. The research enterprise at NIH is based 
fundamentally as are all of our projects on sound basic 
research that we hope to rapidly apply to the clinical setting 
of developing in this case vaccines and therapeutics. We do a 
bit of surveillance and epidemiology at the molecular level to 
look at the evolution of the virus, but the surveillance is 
fundamentally the responsibility of the Centers for Disease 
Control and Prevention.
    I am going to give you a couple of examples of some of the 
basic and clinical research that is done, if I could have the 
next slide. You may have heard of the terminology ``reverse 
genetic system.'' This is a system of being able to much more 
accurately and consistently develop seed viruses for vaccines.
    It may appear to be somewhat complicated, but it really is 
very simple. When we have a virus that we isolate, for example, 
in Asia that we want to make a vaccine for, we generally co-
grow it with a strain that we know works well in eggs and that 
we have a great deal of experience with. During that process, 
the genes re-assort and ultimately give us a good growing, but 
nonetheless specific virus.
    Reverse genetics deliberately takes the appropriate genes 
from each of those strains and re-combines them in a proactive 
way to take away the uncertainty. In fact, the vaccine that I 
am going to mention in a moment, the H5N1, was isolated and 
developed into a seed virus using reverse genetics technique. 
Next slide.
    In addition, we, together with the CDC and in collaboration 
with several of the pharmaceutical companies, are working to 
make the transition from the egg-based system of developing a 
vaccine for influenza to a cell-based culture. The reasons for 
that are several, but the most important of which is the 
greater surge capacity of the cell-based system to be able to 
make more doses on a shorter notice, as well as to change 
direction if in fact we have a surprise virus that comes upon 
us. Next slide.
    Probably the most important component of what we do relates 
to the actual clinical trials and testing of the vaccine in 
question. I must say that in fact we have been the first and 
are still way ahead of the rest of the world in the development 
of an H5N1 vaccine that is taking place in our clinical trial 
sites in this country to determine safety and the correct dose. 
Next slide. Very briefly, the H5N1 inactivated virus trial was 
started on April 5, 2005. We have completed the first two 
stages on 450 people. The dosage data, it will be done in 
multiple doses and in a prime boost will be available for 
analysis by mid-July. The safety data will be available for 
analysis by mid to end of August.
    In addition, we are doing an attenuated vaccine trial that 
is planned for late 2005 for the H5N1. We are also studying 
another bird flu that is not as ominous as the H5, but 
nonetheless important, and that is the H9N2.
    With regard to therapy, we have an anti-viral screening 
program. There are two major classes of drugs. The amantadine 
group, unfortunately the H5N1, that is circulating in Asia now 
is resistant to that. We can talk about why that might be the 
case during the question period. The other is the group that is 
the neuraminidase inhibitors, including Tamiflu. We are also 
looking for other alternative targets, as well as looking at 
how to use these drugs in combination where there are resistant 
scenarios, in addition to how to best use these drugs in 
different categories of patients.
    On the final slide, let me just summarize that the NIH's 
effort is fundamental research, as I mentioned. It is all 
geared to the rapid and expeditious development of the 
important countermeasures that are needed to counter a pandemic 
    I would be happy to answer questions during the question 
period. Thank you, Mr. Chairman.
    [The prepared statement of Dr. Fauci follows:]

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    Chairman Tom Davis. Thank you very much.
    Dr. Gellin.


    Dr. Gellin. Thank you, Mr. Chairman and members of the 
committee. I am pleased to have the chance to discuss with you 
this morning the department's involvement with avian influenza 
and the steps we are taking to prepare for a pandemic.
    As you have mentioned in your remarks and you have heard 
from my colleagues this morning, many public health experts 
believe the threat of a pandemic is now greater than it has 
been in decades. A report by the World Health Organization 
warns that the H5N1 virus may be evolving in ways that 
increasingly favor the start of a pandemic.
    The thin silver lining on this otherwise darkening cloud is 
that despite the wide geographic spread of the virus, despite 
its ability to infect an expanding number of avian and 
mammalian species, despite the small changes in the virus' 
genetics, and despite the occurrence of small clusters among 
people where transmission may have been person to person, this 
virus has not yet developed the ability to efficiently transmit 
among people, a change that could trigger a pandemic.
    While we are all focused on the evolving H5N1 situation, as 
Dr. Fauci mentioned, it is the nature of this virus to evolve. 
Therefore, we need to be prepared for any of these viruses that 
could do a similar thing.
    Because the emergence of a pandemic anywhere could lead to 
a pandemic everywhere, this indeed is a global issue. It is why 
the department has made preparedness for an influenza pandemic 
one of its highest priorities. It is why it is a critical 
component of Secretary Leavitt's 500-day plan. It is why 
Secretary Leavitt on his first international trip in May gave a 
plenary talk at the World Health Assembly, the annual meeting 
of the ministers of health around the world, and hosted a 
meeting of more than a dozen ministers of health in the 
affected region, reinforcing the need for global transparency, 
strengthened surveillance and communications, and timely 
sharing of information and clinical specimens.
    It is also why Secretary Leavitt established a department-
wide Influenza Task Force to coordinate all HHS activities 
affecting the public health preparedness for both seasonal 
influenza and pandemic. It is why HHS has made significant 
investments in adding influenza-specific medicines and vaccines 
to our strategic national stockpile, and why we are currently 
in active discussions with the manufacturers of these drugs and 
vaccines to obtain more.
    It is also why we have supported the World Health 
Organization's global influenza effort through both human and 
financial resources, and why we provide technical assistance 
and other resources through a number of bilateral agreements 
with countries in the affected regions.
    And it is why we have collaborative working relationships 
with many other parts of the U.S. Government, including the 
Department of Agriculture, the Department of State, the USAID, 
the Department of Defense and the Veterans Administration, to 
name a few.
    And it is why Secretary Leavitt has asked that the 
department complete the updated 2005 pandemic preparedness and 
response plan. This plan describes a coordinated strategy to 
prepare for and respond to a pandemic. The updated plan will 
address the outstanding policy issues and provide the guidance 
and specificity that is needed by local and State health 
departments, the health care community, the public and the 
international community. We anticipate that we will be 
regularly revising and reworking the plan that incorporates 
evolving science and experience.
    With the broad area of pandemic influenza, the department's 
priority areas include public health preparedness, 
surveillance, stockpiles of drugs and vaccines, vaccine 
development and advanced product development, and basic and 
applied research. Drs. LeDuc and Fauci have highlighted a 
number of these areas already, so in the few minutes that 
remain I would like to spotlight our approach to developing our 
armamentarium for pandemic antiviral drugs and vaccines.
    As you know, last year we began to include anti-viral drugs 
in the strategic national stockpile. The bottom line is that 
today, neuraminidase inhibitor drugs are the only class of 
anti-virals that can take on this virus. It is worrisome that 
the other class, the M2 inhibitors or the adamantines are no 
longer effective. As recently reported in the Washington Post, 
it appears that the use of these anti-viral drugs in livestock 
feed are largely responsible for the emergence of resistance to 
this virus, underscoring the critical importance that these 
drugs be used appropriately so they will continue to work.
    We are also exploring the potential to include other anti-
viral drugs in our strategic national stockpile, including 
zanamivir, also known as Relenza. I would like to acknowledge 
our appreciation of Congress' inclusion of the $58 million 
supplement so that we could procure these additional 
countermeasures for our stockpile.
    In addition to anti-viral drugs for the treatment and 
prevention of influenza, vaccination is one of the most 
important tools that we have for pandemic preparedness. It is 
important to acknowledge that the perfect vaccine cannot be 
prepared in advance and stockpiled since the vaccine needs to 
be tailored to match the circulating virus.
    We have gone ahead, as Dr. Fauci mentioned, and created a 
vaccine and we have 2 million potential doses that have been 
made in bulk waiting for the result of the NIH trial to know 
what dose should be used. This provides us with some vaccine 
that has potential use and also provides at least one vaccine 
manufacturer with significant experience working with this 
strain in commercial-scale facilities.
    HHS has developed several other influenza vaccine supply 
initiatives that are designed to secure and expand the 
influenza vaccine supply, diversify our production methods such 
as cell culture, and establish emergency surge capacity. To 
support these activities, HHS received $50 million in fiscal 
year 2004, $99 million in fiscal year 2005, and in the current 
President's budget, we have an additional $120 million to 
strengthen this component of our preparedness.
    Our pandemic efforts include beyond the cell cultured 
vaccine that Dr. Fauci mentioned, efforts to improve the 
efficiency of the manufacturing process and approaches that 
could effectively stretch the number of vaccine doses by 
decreasing the amount of vaccine antigen in each dose. These 
dose-stretching strategies may be affected by the use of an 
adjuvant or administration such as interdermal administration.
    While issuing the requests for proposals and completing the 
contracts is only the first step toward development of an 
expanded, diversified and strengthened vaccine supply, as Dr. 
Fauci mentioned, the United States is leading the global effort 
to develop vaccines and vaccine technologies to meet this 
    Thank you for our attention to my remarks, and I look 
forward to any questions you may have.
    [The prepared statement of Dr. Gellin follows:]

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    Chairman Tom Davis. Thank you very much.
    Dr. LeDuc, let me start. It is my understanding that we 
have two medical interventions for addressing a pandemic: a 
vaccine, which could take months to manufacture a sufficient 
quantity; or treatment with an anti-viral such as Tamiflu for 
those who get sick. At the moment, the United States has 
stockpiled only enough Tamiflu for 2 percent of the population. 
What, in your professional judgment, should be the level of the 
Tamiflu stockpile?
    Dr. LeDuc. Clearly, Tamiflu has an important role to play 
in our national preparedness for the threat of pandemic 
influenza. It, however, is not our only resource. As you 
mentioned, vaccines are critically important. I think our 
strategy currently is to use anti-viral drugs through the early 
phase during which a vaccine would actually be made. I think 
our efforts to actively engage in the global community to 
recognize early on the threat of pandemic influenza and to 
shorten the timeline between getting access to that virus and 
creating the new vaccine is also a factor in our 
    I do not have a number to give you. I would probably get in 
big trouble if I put forward a number anyway.
    Chairman Tom Davis. That is why I am asking. [Laughter.]
    But let me ask you, do we have enough?
    Dr. LeDuc. No, we do not have enough. Clearly, we would 
like to have more. Perhaps Dr. Gellin or Dr. Fauci have better 
answers, but clearly we do not have enough.
    Chairman Tom Davis. Dr. Fauci, do you agree with that?
    Dr. Fauci. Yes. We certainly do not have enough right now. 
We are well aware of that, which is the reason why we are in 
the process of negotiating to get more. What the right number 
is, Mr. Chairman, it really is very difficult, if not 
impossible, to give that. You have heard different groups who 
have estimated cover 50 percent of the population, cover 25 
percent of the population. It is very difficult to determine 
what the right number is. I think the question you asked and 
the important point is that 2.3 million treatment doses is not 
enough and we have to get more, and that is the direction we 
are heading.
    What problem we have is that the actual capacity to make it 
in a timely manner when you are having demands from other 
countries and other agencies throughout the world is also 
something that is problematic.
    Chairman Tom Davis. Aren't other countries now trying to 
get more of this? That is I guess the point that you were 
trying to make.
    Dr. Fauci. Yes. So it makes it important for us to get our 
bid in now, yes.
    Chairman Tom Davis. Dr. Gellin, would you agree with that?
    Dr. Gellin. I agree. Let me add to that that as I 
mentioned, we are in active discussions with all the companies 
that make all these products, both vaccines and anti-virals, 
because we are concerned about the capacity to manufacture 
surge capacity in the available supplies. You will likely hear 
from the drug company Roche in the second panel that they have 
recognized this, and after many discussions they have begun to 
develop a U.S. supply chain. So I think that part of what we 
are hearing about are many countries ordering in this case 
Tamiflu, but at the same time my understanding is that there is 
expanding capacity to make that drug.
    I also mentioned in my brief remarks that we are also 
exploring the acquisition of the other neuraminidase inhibitor, 
zanamivir. It is a similar molecule. It has a slightly 
different set of clinical indications. It has given as an 
inhalation rather than oral. We think it is important to 
diversify that as well. It is more complicated to deliver that 
drug, but it is also important because of the potential 
emergence of resistance is that it potentially has a different 
resistance profile, so it would give us some backup.
    Chairman Tom Davis. Dr. Fauci, currently FluMist, which is 
a nasal flu vaccine, is only approved for healthy children and 
adults from 5 to 49 years of age. As you know, we have talked 
about this before. Is there any research underway to consider 
the broader use of MedImmune's FluMist beyond the currently 
approved groups to help alleviate demand for injectable 
    Dr. Fauci. The answer is yes. We are in active discussions 
with the MedImmune people about trying to get the clinical 
information available to expand the usages of FluMist because 
it really is quite a good vaccine. It is a potent vaccine. It 
induces an even broader range of immunity than the kill dose. 
So it would behoove us to go in that direction and hopefully we 
will be able to do the appropriate studies to expand that usage 
beyond the current approval.
    Chairman Tom Davis. Are there other anti-virals besides 
Tamiflu that might be effective against avian flu? Is NIH 
researching alternatives to Tamiflu or ways to speed up 
production of Tamiflu?
    Dr. Fauci. Currently, the neuraminidase inhibitors are the 
only drugs, anti-virals that appear to be effective against the 
H5N1. I mentioned in my statement just a few minutes ago of the 
resistance to the amantadine sub-group of M2 inhibitors which 
is the other class of anti-virals.
    What we are doing in research, Mr. Chairman, is we are 
doing studies to try and determine if combinations of Tamiflu 
plus the amantadine in a resistant strain to amantadine might 
actually enhance the anti-viral effect. There is a good history 
in anti-viral drugs that when you have drugs to which a 
particular microbe are individually resistant and when you use 
them in combination, you get a pretty good effect. We see that 
with HIV and we see that sometimes in tuberculosis.
    So we are doing those studies, and we are also doing 
studies to look at alternative targets. The two categories of 
drugs that I just mentioned are against two major targets: the 
M2 protein and the neuraminidase. We are looking at inhibition 
of entry of the virus, as well as other of the pathways in the 
replication cycle of the virus.
    Chairman Tom Davis. Thank you.
    Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman.
    The three witnesses before us are the good guys. They are 
trying to figure out what to do for our Nation against the 
threat of a pandemic flu, but I do not believe they are getting 
the support they need. Last fall, we had a severe shortage in 
flu vaccines. Our national health officials were caught 
completely unprepared. There were long lines for vaccines and 
widespread chaos and confusion.
    When we examined what went wrong, we learned that the 
Department of Health and Human Services had ignored warning 
after warning that we were unprepared to cope with the vaccine 
shortage. Instead of leadership, our planning was characterized 
by complacency and false assurances.
    So my question today is: Can we prevent the same fiasco 
from happening again? Dr. Gellin, in your testimony, well, you 
are the Director of the National Vaccine Program Office and 
Chair of the Secretary's Influenza Preparedness Task Force. Are 
we as prepared as we should be to face the threat of a 
    Dr. Gellin. Preparedness is not an absolute. I think it is 
clear to say that the efforts that have gone on even on my 
watch in my brief tenure as the Director of the National 
Vaccine Program Office have put us in a much better situation 
of preparedness. Not that I am responsible for those, but I 
think that it attests to much of what is going on. So there are 
clearly many more things that we can do and many things that we 
are doing, specifically around the vaccine piece.
    Mr. Waxman. Let me ask you some questions about the plan.
    Dr. Gellin. Sure.
    Mr. Waxman. You stated in your testimony that the 
department has been actively revising the draft pandemic 
preparedness and response plan. This is something that has been 
going on for a long time. As you acknowledge, the 2004 version 
of the draft contained many holes in key policy areas. Are you 
actively working to fix these key gaps? Will the new draft 
contain information on how vaccines will be purchased and 
distributed? Will the draft address prioritization of scarce 
supplies of vaccine and anti-viral drugs?
    Dr. Gellin. The clear answer to all those questions is yes. 
I think that it is important to recognize that the plan is not 
a skimpy outline. It is a fairly substantial document that we 
have put on our Web site for public comment last July. The 
areas you highlighted are specifically areas that we wanted the 
public to weigh-in on during the public comment period.
    As Dr. LeDuc mentioned, we have involvement both from the 
Advisory Committee on Immunization Practices and the National 
Vaccine Advisory Committee to provide recommendations so that 
those critical policy issues can be answered. We cannot have a 
plan updated without those being addressed.
    Mr. Waxman. Can you tell us a date by which this report 
will be released?
    Dr. Gellin. I cannot tell you a date. As mentioned before, 
it is our expectation that it will be released this summer. 
There are many moving parts to this and they are converging to 
the Secretary, who wanted to see it in early August. Subsequent 
to that, it is our hope to get that out shortly thereafter.
    Mr. Waxman. Well, the States have been saying they are not 
getting adequate guidance from the Federal Government. I hope 
what you finalize will be much more thorough than last year's 
    Dr. Gellin. As you mentioned in your introductory remarks, 
what we will have here is the specificity that the States are 
looking for so they can go on and make their own State-level 
    Mr. Waxman. Dr. LeDuc, I appreciate your observation that 
the issues of pandemic influenza and annual influenza are 
linked. You noted that the same laboratories, the same health 
care providers, the same surveillance system and the same 
health department plans and personnel will guide both 
    I would add that these factors link pandemic flu to many 
other public health issues, not just to annual flu epidemics. 
That is why I am so concerned the administration is proposing 
to cut support for local and State health departments by $130 
million. The Secretary of the Washington State Health 
Department will testify in the next panel that these cuts are 
proposed at exactly the wrong time.
    Why are we reducing the ability of State and local health 
departments to respond to a potential pandemic when health care 
experts say the risk of a pandemic are increasing? Given the 
threat of pandemic flu, would it be responsible for Congress to 
increase support of State and local health departments? I know 
you are not setting the funding priorities for the 
administration, but your concern over the pandemic flu should 
translate into more support for public health at HHS and in the 
White House.
    In theory, public health is not a partisan issue. In 
practice, the funding of public health is more contentious, 
unfortunately, than it should be. What is your response?
    Dr. LeDuc. Well, sir, I wholeheartedly support those 
comments. I could not agree more with your observations. I 
would just offer a hearty ``yes, sir'' that these are in fact 
very serious issues.
    I think the threat of pandemic influenza, annual influenza, 
are just a few examples of the broader issue of emerging 
infectious diseases, many, many infectious disease threats that 
are facing the Nation. Clearly, we need a strong capacity at 
the State and local level to address these issues as a Nation.
    Chairman Tom Davis. Thank you for your comments.
    Mr. Gutknecht.
    Mr. Gutknecht. Thank you, Mr. Chairman.
    Let me just first of all disagree to a certain degree with 
my distinguished colleague from California, and let me make the 
point. The last several years, we have heard every year of this 
impending shortage of vaccine and the potential calamity that 
would follow thereon. I think in the last several years in 
every case it has proven not to be quite as serious as we 
    I think we have to be careful of that. The reason I say 
that is that more and more the public, if you cry wolf too many 
times, the public does not take it very seriously. So I think 
we have to be careful as public policymakers to essentially say 
that there is a huge shortage out there; there is a huge public 
danger. I think there is a serious problem and I think we have 
to deal with it.
    Just for my benefit and I think for the benefit of the 
American people, could you just in language that we can all 
understand explain the difference between an epidemic and a 
    Dr. Fauci. There are technical explanations, but in plain 
English, an epidemic is when you have a much greater than 
expected surge of cases within a particular defined geographic 
location. You could have an epidemic in a particular State or 
an epidemic in a particular region.
    When you are talking pandemic, ``pan'' being ``all,'' it is 
essentially all over the place, in plain English. That is 
really what a pandemic is.
    Mr. Gutknecht. Let me come back to some other basics, just 
again so that I and others understand. What we are really 
worried about here are viruses that mutate and go from pigs to 
poultry to people or from poultry to pigs to people. Isn't that 
    Dr. Fauci. Yes.
    Mr. Gutknecht. And I am wondering, and the reason I am 
going to ask this question, I will tell you a little bit about 
two laboratories that I have in my district. One is a little 
medical practice that was started by a fellow by the name of 
William Worrall Mayo and his two brothers Will and Charlie. 
They have a pretty sophisticated laboratory there and they are 
doing some amazing things.
    In fact, I was there a couple of months ago and they have a 
super-computer where they had taken the SARS virus and they 
showed the three-dimensional representation of the SARS virus, 
and they have actually tested using the computer the 10 most 
likely vaccines against the SARS virus, and have determined 
what they think would be the most viable.
    The other is a little laboratory down in Worthington, MN 
run by some veterinarians. It is called Newport Labs. I will 
tell you the story, and the reason I tell the story is that 
what they do is they test animals. People will send cotton 
swabs in from around the country, and within 24 hours using 
very sophisticated, I think it is called PCR technology, they 
will determine what virus it is. More importantly, they will 
send back to them the right vaccine.
    The reason I raise this question, and I think it is 
important that we continue to develop the vaccines and the 
other things, but what are we doing to try and, it seems to me 
if we could vaccinate the pigs and the poultry in Asia, maybe 
it is just a layman's view, but if we could keep the disease 
from ever becoming a pandemic, it would make some sense.
    How much are we working with veterinarians and laboratories 
like that to try and stop the thing before it starts?
    Dr. LeDuc. Let me start commenting. Dr. Fauci, I am sure, 
will have a lot to add.
    First with regard to influenza in general, there are many 
strains and they actually exist in nature in wild birds. So 
there is basically a silent cycle and a silent reservoir of 
these strains. That is why Dr. Fauci pointed out that while 
H5N1 influenza is the current hot topic, we are also concerned 
about H9N2 and other strains. So there is this silent reservoir 
of circulating virus that is completely impossible to control.
    The decision whether or not to immunize domestic animals as 
an amplifying host and a link to human transmission is often 
made on economic basis, in addition to the availability of an 
intervention of vaccine.
    Unfortunately, we do not have the kind of ongoing dialog 
that we should have between the health sector and the 
agricultural sector. In an attempt to resolve this problem, we 
have actually assigned a person to WHO who comes from the 
agricultural sector. His sole job is to focus on influenza 
issues and establish a more robust dialog with the FAO and the 
OIE and WHO to try to approach a coordinated response on how to 
integrate control both on the agricultural sector as well as 
the human health sector. So we are trying to work on this.
    Dr. Fauci. Just to add to that, to make sure we emphasize 
that is at the international level. We have good discussion and 
coordination. In fact, we just had a meeting yesterday at the 
White House with all of the parties involved, the Department of 
Agriculture included in that.
    But from an international standpoint, I think the critical 
point that Dr. LeDuc made is it is so tied to the economies of 
the country that we are going to need a good deal of greater 
transparency in what is going on in those countries, and a 
willingness to assume some of the economic burdens and issues 
that will go along with appropriate culling, appropriate 
vaccination, getting a good vaccine.
    One of the things we are worried about is that if you 
vaccinate some of the chickens, for example, with a partially 
effective vaccine, you may mask some smoldering infection. That 
is superimposed upon with what Dr. LeDuc said about the 
migratory birds being infected, which is very difficult to get 
a handle on. It is a very complex issue that at the level of 
WHO, working very close with the CDC and with the international 
counterparts, we are trying to address that. But it is a very 
difficult problem when you have economic considerations very 
closely tied with that.
    Dr. Gellin. If I could add, what you have described and 
what you have heard from my colleagues is really what is 
captured in the phrase ``emerging infectious diseases,'' those 
that come out of the human-animal interface.
    In addition to what Dr. LeDuc mentioned about some of the 
specific activities, there is also a supplement to the tsunami 
relief bill that is provided through the Department of State 
and HHS $25 million to focus on some of the strategic countries 
in Asia. One of the underlying focal points of that is to do as 
you described, to bridge the human and animal side so there is 
a common agenda.
    Chairman Tom Davis. Mr. Cummings.
    Mr. Cummings. Let me followup on what Mr. Gutknecht said. I 
have a question, and something he said was chilling to me. Let 
me ask you this, gentlemen. In 2001, we had shortages of 
vaccine for children covering 8 of 11 others; 8 of 11 we did 
not have. Is that correct? And children died, did they not? Say 
yes or no, so I can hear you. I mean, it is for the record.
    Dr. LeDuc. I believe that is correct, sir.
    Mr. Cummings. Children died.
    In 2004, we had a shortage of flu vaccine and elderly 
people waiting in lines. Some of them actually died in line, 
and 36,000 people die each year from flu. Is that accurate? 
Come on, gentlemen.
    Dr. LeDuc. That is correct, sir.
    Mr. Cummings. I am sorry?
    Dr. LeDuc. That is correct, sir.
    Mr. Cummings. So my question is, do you think that we are 
crying wolf here? I mean, it is our responsibility as Members 
of the Congress to protect our citizens. I am just asking you, 
do you think we are crying wolf here?
    Dr. Fauci. No, but let me just add to what I think you are 
saying. We have discussed and we could reiterate, I certainly 
have at this committee in the past, and I mentioned it to the 
chairman as we were giving our statement, there is no doubt 
that the vaccine enterprise certainly in this country, and you 
used the word ``fragile.'' You are absolutely correct. It is 
not only fragile. It is sort of broke, as it were.
    The reason is that there is very little incentive to get 
vaccine companies involved in vaccine. We discussed this in 
light of the shortages. We have discussed this in the light of 
biodefense countermeasures that we need. We have a serious 
problem. So in that regard, I do not think you are crying 
``wolf.'' We have to fix the vaccine enterprise and make it 
such that consistently each year we have a predictable and 
supportable amount of vaccines.
    Probably more broke than any of the vaccine sub-groups is 
the vaccine enterprise associated with influenza because it 
adds the seasonal uncertainty touch.
    Mr. Cummings. Let me ask you this. Dr. LeDuc, the Baltimore 
Sun recently reported ``anti-viral drugs like Tamiflu are 
essential tool in slowing the spread of disease until a vaccine 
can be developed to immunize people, a process that can take 
six to 8 months from the time a killer virus is identified.'' 
Listen to this, ``The United States has enough Tamiflu on hand 
for 2.3 million people,'' as you all have testified, 
``significantly less than some other nations. The United 
Kingdom, for example, has enough Tamiflu to treat 25 percent of 
their population, in accordance with the World Health 
Organization's recommendation.''
    What is the CDC doing to ensure the United States has 
enough anti-viral drugs to combat a pandemic and identify 
priority groups who will be most in need of that treatment? And 
why is it that other countries are able to cover a greater 
percentage of their people than we are? We have 36,000 people 
dying a year, and nine times as many people as who died on 
September 11th.
    Dr. Gellin. Let me get back to the heart of your question 
about the supplies in the stockpile and some of these 
materials. As I mentioned, and as Dr. Fauci mentioned, we have 
also been very aggressive about vaccine development. We see the 
need for both vaccines and anti-virals in the stockpile. You 
have heard in some detail about where we are going in the 
clinical trials, the going ahead and manufacturing 2 million 
doses, the request with manufacturers to make additional 
    At the same time, we have actually bought and secured that 
amount of anti-viral in the stockpile. There will be subsequent 
purchases in the near future that are now under discussions 
with the companies, and additional purchases beyond that.
    So it is important to recognize that we are not stopping at 
2.3 million. As a point of fact, the other countries have put 
these other targets out there, not that it is a WHO 
recommendation per se, but they do not have much of a vaccine 
strategy right now so they have been putting more of their eggs 
in that anti-viral basket. We think that we need a balanced 
strategy as well, but I want to summarize by saying we are not 
stopping at 2.3 million. You will hear more in the near future 
about more and subsequently about additional purchases.
    Mr. Cummings. Before my time runs out, let me just ask you 
all this question. The Baltimore Sun recently reported about a 
pandemic flu simulation that occurred in my district, an 
affluent county, Howard County. A wide range of participants 
included representatives from the Governor's office and State 
and local public health officials.
    The Sun reported, ``It was not just the deaths in the 
scenario that disturbed them. Medical supplies were in short 
supply; absenteeism was soaring; police, firefighters, medical 
workers and air traffic controllers were among the thousands of 
sick, dead or terrified; hospitals and mortuaries were 
overwhelmed; the first small batches of the vaccine were 
arriving, but they were reserved for health care and public 
safety workers; crowds gathered demanding vaccination, and 
small riots were breaking out.''
    I just want your reaction to that, when we talk about our 
State and local folks, because they are on the front lines.
    Dr. Gellin. Indeed, they are on the front lines. I read 
that newspaper when it was on the stand. I think that depicts a 
number of the concerns about what a pandemic could do, which is 
why I believe that the plan will provide better guidance for 
the States as far as how they go about this, and the subsequent 
purchases of additional materials will help as well.
    This all builds on the level of preparedness that has been 
encouraged by other funding, so I believe that these States are 
better prepared than they were before all this started.
    Mr. Cummings. Thank you, gentlemen.
    Mr. Shays. Mr. Chairman.
    Chairman Tom Davis. Yes, Mr. Shays.
    Mr. Shays. Thank you.
    I thank our witnesses again, and I thank you for holding 
this hearing.
    I would like to know when does HHS propose to have a final 
version of a epidemic preparedness plan? Let me just throw 
these other questions out. Do you anticipate finalizing the 
plan before the 2005-2006 annual flu season? Are there 
practices and guidance in epidemic planning that are relevant 
should we experience another flu vaccine shortage this year?
    Dr. Gellin. Let me start with that. The plan, and I would 
be willing to loan you my copy of our draft plan, will be 
finalized this summer and it will include the specific guidance 
the States and localities are looking for. It will also include 
some of the strategic policy issues such as priority-setting 
when there are short supplies of vaccines and anti-virals. So 
all those will be done this summer in advance of the flu 
    Dr. LeDuc. If I could just add to that, actually this 
afternoon the ACIP is going to engage in discussions on the 
guidance on vaccine and anti-viral drug prioritization and 
their comments will then roll over to end back later on next 
month as well. So this really is a very timely discussion and 
we hope to have the final draft to the Secretary by the first 
of August. So we are moving along on this.
    Mr. Shays. OK. Now, the draft plan only addresses HHS's 
activities. Correct? Yes. Given the broad nature of a pandemic 
and its impact on commercial agriculture, homeland security, 
and just society in general, does the administration have plans 
for governmentwide coordination and has anyone outside HHS been 
designated as the lead for orchestrating this coordination?
    Dr. Gellin. As Dr. Fauci mentioned just a few minutes ago, 
this coordination has been quite active. Within the Department 
of Health and Human Services, Secretary Leavitt sort of 
influenced the task force to deal with both pandemic influenza 
and annual influenza, given their relationships. There is a 
process that has really been coordinated by the White House to 
assure that there is broad input by all the departments that 
have a piece of this. I think in part it will also follow on to 
the national response plan for which there is likely to be a 
pandemic supplement.
    Mr. Shays. One of the things that I am struck by is that 
Dr. Fauci when you said we just really do not know how many 
vaccines are the appropriate number. Is that correct?
    Dr. Fauci. I was referring to drugs, Mr. Shays.
    Mr. Shays. OK.
    Dr. Fauci. I was asked what the right number of drugs was. 
We have 2.3 million treatment doses, and the question was what 
is the right number. I said clearly 2.3 million treatment doses 
is not enough.
    Mr. Shays. What I am struck by, it seems to me by now we 
would almost have formulas that would come into play. First 
off, clearly this is the reason it is a pandemic, in that it is 
worldwide. Correct?
    Dr. Fauci. Right.
    Mr. Shays. And obviously then we have a great deal at stake 
in what other countries do. The more vaccines that are out 
there worldwide, the less people in the United States will 
contract it. Correct?
    Dr. Fauci. Right, yes.
    Mr. Shays. But isn't there a formula that tells you that?
    Dr. Fauci. The answer, Mr. Shays, is yes there are. There 
are mathematical models. The difficulty with the mathematical 
model as in all mathematical models, they are totally based on 
what the assumptions are that you put into the model. When you 
get predictions about how many people will get infected versus 
who will get sick, the range is enormous. It goes from 89,000 
to several hundreds of thousands of people. If you are going to 
base who you are going to treat, treat sick people.
    So if you have such a variability, then the number of doses 
you will need for sick people is going to be widely variable. 
Then you make the decision about is there going to be enough 
for health workers, and those formulas are easy because you 
know how many health workers you have. Are you going to have 
treatment available to incentivize health workers to come to 
work in the middle of a pandemic flu? That number is pretty 
easy to get.
    The number that is the big variable is what is going to be 
the infection burden among people in this country. We have 
looked at those models. Obviously, it is greater than 2.3 
million. Some say it is as high, in our own group, as 20 
million treatment doses.
    Mr. Shays. How long does a vaccine last?
    Dr. Fauci. Vaccine differs from therapy. Therapy shelf-life 
is about 5 years for Tamiflu. A vaccine, if you store it well 
it can last for a few years. The difficulty with vaccines is 
that the nature of flu is that it keeps changing, so it is not 
a shelf-life issue. It is an effectiveness issue.
    Mr. Shays. Thank you, Mr. Chairman.
    Chairman Tom Davis. Mr. Ruppersberger.
    Mr. Ruppersberger. Let me have 5 minutes. There are three 
issues I would like to get into. No. 1 is planning. Congressman 
Shays got into it. I want to get into a little more specifics, 
the issue of injection devices, which I think are very relevant 
because it might be a way for us to use less vaccine and it 
might even be better. I think we need to look at that.
    Also the issue of Tamiflu as it relates to children. Is 
there clinical testing going on right now? Let me get to that 
real quick. Where are we with Tamiflu and children?
    Dr. Fauci. Tamiflu is approved for children greater than 1-
year-old for treatment and in individuals 13-plus years for 
prophylaxis. We are in the process of discussions of clinical 
trials to gather more information, particularly about the 
safety of Tamiflu in children 2 years of age and younger.
    Mr. Ruppersberger. I also understand that you are having 
problems with the industry as it relates to Tamiflu; that you 
are not getting the support that you need. Is that still the 
    Dr. Fauci. I would say more that we are in active 
discussions trying to get that.
    Mr. Ruppersberger. I think that is really something that we 
need to deal with from an adversary point of view. If you want 
to lay it out now, I think we should discuss it because if 
industry is not cooperating, then we are putting everyone at 
risk, including the children. Where are we with respect to that 
issue, other than just saying ``discussions?''
    Dr. Fauci. We are just in discussions, sir. I am not trying 
to evade the question. I checked with my staff yesterday and 
they said we are in active discussions about how we are going 
to get that information.
    Mr. Ruppersberger. It seems to me it should be aggressive 
    Dr. Fauci. We, the NIH, are in an aggressive discussions.
    Mr. Ruppersberger. OK. Let me get to planning. In August, 
the administration released a draft, you probably have it 
there, you talked about your being before the Commerce 
Committee or whatever, saying you will have the draft this 
summer. You just testified to that.
    Now, there were key elements in the first draft that were 
not addressed. I think we can all say that a key element of 
preparing for a flu pandemic is having a plan. Would you agree 
with that?
    Dr. Fauci. Absolutely.
    Mr. Ruppersberger. OK. Now, if that is the case, the areas 
that we are missing were undecided questions including how 
vaccines will be paid for and distributed; second, how scarce 
supplies of vaccines and drugs will be prioritized; and three, 
what messages will be communicated to the public in different 
stages of the pandemic.
    Will they be addressed in the plan that you are coming up 
with this summer, those three elements?
    Dr. Gellin. Yes, to all.
    Mr. Ruppersberger. OK. I want to ask this question, too. I 
do not want to embarrass you because we want to move forward, 
but it seems to me that why don't we have a plan now? Canada 
finalized their plan in 2004. The United Kingdom finalized 
their plan in March 2005. Why is it taking us so long to get 
from the draft stage to the final plan?
    Dr. Gellin. We put out a draft last year and we left those 
areas open honestly to engage public discussion. We are 
disappointed with the lack of public input. We received few 
more than 50 comments to the plan that was posted in a 60-day 
period, because we thought that these areas, particularly the 
priority groups, were so important because as a pandemic could 
likely affect everybody in America, let alone everybody around 
the world, that we wanted to hear what people had to say and 
what the stakeholders had to say.
    When we did not get much from that, we set up a process 
through the National Vaccine Advisory Committee and the 
Advisory Committee on Immunization Practices to begin to 
process that. There is a discussion this afternoon in Atlanta 
about that, and there is a joint meeting which I believe is the 
first joint meeting ever of these two Federal advisory 
committees in mid-July to come up with these recommendations to 
provide the Secretary.
    Mr. Ruppersberger. When you are talking about the health, 
safety and welfare of people, and then the media picks up on 
something, a lot of times the issue gets larger than maybe it 
is. But we cannot take any risks. I mean, we cannot take it for 
granted that there is not going to be a problem. I really think 
that it is important for the mindset of the industry, which is 
part of you all, to really start prioritizing and really do 
things quickly, and then communicate that to the public.
    I can understand your answer about getting people to 
testify and doing it right, but as it relates to what is 
happening with flu, and now we hear about the bird issue, and 
that we really do not know what to do until it happens, are we 
ready to go, do we have the instrumentalities necessary.
    With that, I want to get into injection devices. We talk a 
lot here about how much inventory we are going to have as far 
as the vaccine, but where are we with respect to injection 
devices? First thing, how many injection devices will be 
necessary to provide for the pandemic flu vaccine for the U.S. 
population? Can you answer that, anybody?
    Dr. Gellin. If it is the entire population, and we believe 
that there is going to be a requirement for possibly two doses, 
that number would be 600 million.
    Mr. Ruppersberger. Do you have a plan you can provide this 
committee on what these devices would be like? Do we have the 
technology necessary to make sure that they will do the job? 
Are we ahead of the curve as it relates to the rest of the 
world, as it relates to injection devices? And finally, do they 
work? Is it going to make it more efficient and using less of 
the flu vaccine if we use these devices instead of the needles 
that we use now?
    Mr. Shays [presiding]. That will have to be the last 
question answered.
    Dr. Gellin. OK. There are several questions in there. Let 
me get to what I believe is the most interesting part of what 
you ask, and I may ask Dr. Fauci to back me up on that.
    There is a global capacity for vaccine production of about 
300 million doses of the trivalent vaccine. If you are going to 
make a single strain vaccine, so instead of three strains, a 
single strain, that could give you globally in a year maybe 900 
million doses. That is the global industrial capacity.
    Therefore, some of these devices that I think you are 
getting to might allow us to actually use less antigen per 
dose, and effectively stretch that global supply.
    Dr. Fauci may want to get into some of this. The 
conversations they are having with the companies now to do 
those studies. There was one report in the New England Journal 
of Medicine last year which are promising, but we need to make 
sure these things work and provide the immune response that 
they need to.
    Dr. Fauci. We are actually in discussions about doing 
trials with different approaches, interdermal versus inter-
muscular. Inter-muscular is simple needle-use. Injected 
interdemal, you can make it much more consistent if you have a 
    Of course, it is not very difficult, but it requires some 
training to get the injection into the skin, which is what we 
called intra-dermal. That requires a different kind of an 
approach. We are in negotiations about doing a trial comparing 
one to the other. That does not address directly the question 
of how many of these devices are going to be available. It is 
more the proof of concept of whether or not you can use them.
    Mr. Shays. Thank you.
    The gentleman is right. Five minutes is not much time, but 
he had 7 minutes.
    Mr. Ruppersberger. Mr. Chairman, could I just ask for the 
record, not a question, but put a question for the record?
    Mr. Shays. Sure.
    Mr. Ruppersberger. Do you think that the intra-dermal 
delivery of influenza vaccine has the potential to improve our 
preparedness for a flu pandemic?
    Mr. Shays. And right after we find the answer to that 
question, we will throw it out, and before you leave we would 
like you to answer that question.
    Mr. Dent.
    Mr. Dent. Thank you, Mr. Chairman.
    Good morning. I represent an area very close by, the 
Aventis plant up in Swiftwater, PA, and of course the flu issue 
is a big deal where I live, as it was in many communities. It 
caused me to think quite a bit about what lessons have we 
learned from this past season's flu vaccine shortage as far as 
distribution, prioritization and communication between State 
and local health officials, and what can we do to be better 
prepared for when an actual pandemic occurs, not just one that 
is naturally occurring, whether it be a flu, but perhaps some 
genetically engineered pathogen that could be injected by some 
non-state actor, from a homeland security standpoint. Can you 
just tell us the lessons that you have learned?
    Dr. LeDuc. Thank you very much for that question, sir. 
Clearly, the challenges that we faced with the influenza 
vaccine availability last year brought home several lessons, 
one of which is the critical importance of communication and 
active partnership with State and local health departments and 
partners as the situation evolves.
    Another lesson is the real need for real-time 
communications on what is going on. Concurrently with that, a 
need for real flexibility because these issues we really do not 
have control over a lot of the situations that we are faced 
with. In that regard, we also learned that it is important to 
have plans in place up front that look at a variety of 
potential outcomes, especially with regard to delivery of flu 
vaccine in this particular case.
    The other issue that we learned was that if we try to use a 
non-licensed product under an investigation of new drug 
application, that becomes very problematic. It is difficult to 
implement those.
    Finally, I think the other lesson we learned is that it is 
very, very difficult to get the public to accept influenza 
vaccine beyond December of the calendar year.
    Dr. Fauci. There is another issue also, I just might add to 
that. It has to do with a question that I answered in response 
to Mr. Cummings' question. That is the vaccine enterprise and 
how fragile it is. What we do need is American companies making 
vaccine on American soil. We have foreign countries making it 
in Swiftwater. We have American companies making it in 
Liverpool. What we need is to have a greater commitment on the 
part of our own industrial partners here in the United States 
so that we can have a steady flow, and understanding of that 
each year.
    Mr. Dent. What was your understanding as to why the vaccine 
flu was not being produced up in Swiftwater where they have the 
capacity to do so?
    Dr. Fauci. No, no, Swiftwater is doing a terrific job. They 
were our sole source this past year.
    Mr. Dent. Correct.
    Dr. Fauci. No, the point I'm making is that we need to 
incentivize more companies to get involved in influenza vaccine 
manufacturing and production. That is what we really need.
    Mr. Dent. How would you incentivize those companies?
    Dr. Fauci. Well, we have discussed again before this 
committee and other committees a number of things. There are 
several issues that have to do with financial incentives, and 
even stabilizing the influenza market, as it were. The CDC and 
the department has been trying over the past couple of years to 
get a greater number of people each year to routinely get 
vaccinated. We used to do 50 million or 60 million. We got it 
up to 80 million. We tried to get it to 100 million last year. 
We in fact probably need to go up to 150 million to 180 
    Once we do that, then you have a stable pool of people who 
will be getting vaccinated, which makes it much more attractive 
to industry to get involved in a stable market, as opposed to a 
market where they do not know from 1 year to another whether 
they are going to have to throw away 10 million doses.
    There are other incentives regarding liabilities and things 
like that we have spoken about in the past.
    Mr. Dent. Thank you. No further questions.
    Mr. Shays. Thank you.
    Mrs. Maloney.
    Mrs. Maloney. You are the guys trying to help us solve this 
problem. I represented a city that really was in crisis when we 
did not have the vaccines. It was really terrible. We want to 
prevent that.
    I think, Dr. Fauci, you hit it on the head when you said we 
have to produce it right here in the United States. One of the 
problems is we had to fly over to England. Then there were 
these questions about their standards, are they the same as 
ours, and all other kinds of things.
    I guess we need to figure out how to handle this better. I 
guess I just want to hear any other ideas about how we can 
stockpile it here in the United States, it you cannot 
manufacture it, and then at least have the stockpile here. And 
do we have the budget in place to make these purchases?
    One of the problems we had in the last crisis is that we 
could not buy it or we did not have the money to buy it, and 
there were all kinds of problems about making sure that when we 
were buying it overseas, it did meet the health standards of 
the United States, and how can we plan that better? Obviously, 
it would be better to manufacture it in the United States, but 
if we are not manufacturing it in the United States, how can we 
guarantee that we are going to have several people 
manufacturing it so that if one person has a problem in 
maintaining certain standards, there is another place we can go 
    I guess an important question is the budgeting. Do we have 
the budget to buy a stockpile and to put in place the planning 
for it.
    I would like to start with Dr. Fauci and anyone else who 
would like to answer.
    Dr. Fauci. Thank you, Mrs. Maloney. That is a lot of 
questions there. Let me just take one of them to answer because 
it relates to what I just mentioned a moment ago, is how are we 
going to get these companies involved. That relates to the 
incentives that we need. We need a stable pool of people. We 
need protections against the liabilities that they face. We may 
even need things like tax incentives to build plants in the 
United States.
    The issue of stockpiling, I will make a quick comment then 
I am sure that Dr. LeDuc can comment on that since the CDC is 
involved in small stockpiling issue each year.
    Unlike other pharmaceuticals, it is very difficult to long-
term stockpile influenza vaccine because even in a non-pandemic 
situation, it changes a bit from year to year, so almost 
invariably we have to deal with a small, sometimes moderate 
modification of the vaccine from year to year. So stockpiling 
for influenza just does not work in the big picture. You need a 
little stockpile the way the CDC has for the emergency 
situations, but a broader stockpile is just not tenable when 
you are dealing with a changing virus from year to year.
    Dr. LeDuc. I would just agree with those comments. 
Stockpiling is not the solution to this particular problem for 
influenza. I think, as Dr. Fauci and Dr. Gellin have both said, 
the real issue is the fragility of our vaccine enterprise, and 
we really need to address that.
    Dr. Gellin. If I could comment, I think it is important to 
look at some of the changes in the marketplace. In 1990, as a 
Nation, we used less than 30 million doses of influenza 
vaccine. That has been ratcheted up over time and there are a 
variety of reasons why that has been the case, but as a Nation, 
we have never used more than 83 million doses, while the CDC 
recommends that more than twice that many people receive an 
annual flu shot for their own personal health benefits.
    Nevertheless, those numbers have increased dramatically. At 
the same time, I do not have the pricing information, the price 
has gone up; the reimbursement rates by CMS have gone up. It 
has become a more interesting marketplace for many 
manufacturers. We have seen this, and I think maybe it was last 
year that provided an opportunity for many more manufacturers 
to come and discuss with us. Dr. Fauci mentioned NIH working 
with GSK to produce some of the data, so they have brought 
their license application.
    So I am hopeful that we will have more manufacturers to the 
marketplace in the near future.
    Mrs. Maloney. My time is almost up. I just would like to 
throw out, obviously we do not have time to get manufacturing 
going in our own country, so what are we going to do for next 
year? Last time, we only had one manufacturer, as I recall, 
that we were working with in England, and they were not up to 
our standards.
    Are we contracting now with certain manufacturers in other 
countries for just this coming year? This is a long-term 
problem. We hear you and we are going to try to do something 
about it, but this flu season will be coming quickly and we do 
not have time to adjust in the United States. We are going to 
be dependent on foreign importation again, and how are we 
planning on that?
    Dr. Fauci. We have Sanofi-Pasteur standard, which was 
successful interaction with the last year. Chiron is getting 
back. It is a bit unclear exactly how many doses they are going 
to be able to give us, but there is a range of doses. We have 
been working with GlaxoSmithKline from the previous year about 
trying to get them in the market for X amount of doses, not 
exactly certain. So we now have at least three companies, in 
addition to MedImmune with their FluMist. So it is not just the 
single company for this coming year.
    Mrs. Maloney. Thank you. My time is up.
    Mr. Shays. I thank the gentlelady.
    We will turn now to the former chairman of this committee, 
Dan Burton.
    Mr. Burton. It is nice seeing you gentlemen again.
    First of all, I want to congratulate you on addressing this 
issue. I think it is very important. I think we are all 
concerned about a major flu epidemic that might be started by 
radicals to try to destroy this country, or at least a part of 
    The question I would like to ask you deals with another 
subject. I know that you are aware that for about 4 or 5 years 
we held hearings when I was chairman of this committee on the 
mercury in the vaccines. I am very much in favor of the vaccine 
programs. I think they have given us the highest quality of 
life in the history of mankind. But we have gone from 1 in 
10,000 children who are autistic, and I know there are 
questions about how you define somebody that is autistic and 
they split hairs on this, but we are now, according to CDC, at 
1 out of 166 children that are autistic.
    We had scientists and doctors before the committee when I 
was Chair that told us that there was no doubt in their minds, 
and these are not just fly by-night doctors and scientists, 
these are people from all over the world that believe that one 
of the major contributing factors of the autism and the 
epidemic of autism was the mercury in the vaccines.
    Recently, Robert F. Kennedy, Jr., wrote an article which 
talks about meetings that took place in secret with our health 
agencies and some of the pharmaceutical companies. I will be 
happy to get you a copy of that. Have you seen that article? Do 
you know what I am talking about?
    So there is a great deal of concern among people in this 
country about the mercury in the vaccines and the effect of 
that and what it is going to do to people long term, especially 
the kids who are going to live a long life and many of whom 
will be disabled because of the autism or neurological 
    But we are here today to talk about the flu vaccine. Every 
Member of Congress that I know of that is concerned about flu. 
At my age, we get a flu vaccine shot. I have gotten mine this 
year, even though I knew there was mercury in it. We still have 
thimerasol in most of the adult vaccines. Many of the 
scientists that came before this committee told us that not 
only did the mercury in the vaccines contribute to neurological 
disorders in children, but they believed it also had an adverse 
impact on older folks and could be a contributing factor in 
neurological problems such as Alzheimer's disease.
    So I would just like to ask you, why don't we get the 
mercury out of all vaccines? It is not necessary. I know that 
they use because they use it in 10- or 20-shot vials for 
production purposes, but we could go to single-shot vials and 
eliminate that. I would like to know what our health agencies 
are doing about getting mercury, which is a very toxic 
substance, out of all vaccines.
    In my district, we had a small breakage of a container that 
contained mercury. It was not much more than what would fill 
this cup. They evacuated two square blocks of people and 
brought in the fire department people to clean it up in 
uniforms that looked like they were from outer space. It was 
because mercury is so toxic.
    Here in Washington, DC, they spilled some mercury in a high 
school laboratory and they burned all the children's shoes and 
clothes and everything else and got everybody out of the school 
while they cleaned up the mercury in that room.
    So we know mercury is one of the most toxic substances in 
the world. It makes no sense to me to continue to have it in 
our vaccines. There is a growing body of evidence and 
scientists that believe that the mercury in the vaccines 
contributes to these neurological disorders in children and 
adults, and I would like for you to tell me today you are going 
to get it out of all vaccines. So, can you give me an answer, 
    Dr. LeDuc. Bruce might have more information, but you are 
right, sir. The single-dose vaccines for pediatrics, for I 
think all childhood vaccines, are free of mercury.
    Mr. Burton. There are three that still have mercury in 
them, three children's vaccines still have mercury.
    Dr. LeDuc. I stand corrected then. I know at least the 
material that we have purchased for the stockpile for influenza 
is free of thimerasol.
    The multi-dose vials, you are correct, continue to have a 
trace amount of thimerasol as a preservative in it. I do not 
have an answer as to how industry is going to work through 
that. Perhaps my colleagues do.
    Dr. Fauci. Certainly the ultimate goal is just what you are 
saying, Mr. Burton, is to get it out of all of the vaccines. 
The difficulty we are facing with influenza is the double 
problematic issue of trying to rev up and make it in as 
efficient a manner as possible, which really requires multi-
dose right now. If to get it in a single dose, it would really 
be very difficult to meet the goal. That is not an excuse for 
forgetting about the issue of trying to get a thimerasol-free 
vaccine ultimately, which is what we are ultimately trying to 
do. But, unfortunately, it is not going to be for this year's 
    Mr. Burton. If the Chair would bear with me for one more 
real brief comment. Dr. Fauci, I have high regard for all of 
you. I know that may seem insincere after all the hearings we 
have had, but I really do have high regard for all of you and 
our health agencies. I think you are doing the Lord's work by 
trying to protect this country. But we have been talking about 
getting mercury out of vaccines for at least 10 years, and it 
seems to me that the health agencies could put pressure on the 
producers to come up with an alternative to what we are using 
to make sure these vaccines are safe in multi-shot vials. 
Either that, or going to a production system that will create 
single-shot vials. And if we did that 5 years ago, 4 years ago, 
we wouldn't be talking about, oh, we can't do it right now on 
the flu vaccine.
    So I really hope and I pray for the health of these people 
that are having these neurological problems--and the ones who 
will have them in the future--that we get on with the program 
and get mercury out of all vaccines as quickly as possible.
    Thank you, Mr. Chairman.
    Mr. Shays. I thank the gentleman.
    Ambassador Watson.
    Ms. Watson. I want to thank the Chair and also the 
panelists for coming here, talking about influenza and our 
preparation. What I noticed last year is that we were 
scrambling around, and since Chiron admitted that its supply 
was contaminated, that put us in a very bad position and we saw 
people who really needed to get their shots, not being able to 
access the shots, and had to wait in long lines for hours, 
particularly our seniors.
    So my question for Dr. Bruce Gellin is how are we planning 
if we run into this situation again--and I have been listening 
very intently. It seems like the supply is limited and we can't 
keep a supply over a period of time, and we seem not to have 
been able to buildup the capability to produce the solutions 
here for the shots. So what are we doing? How are we planning 
to take care of those in need? Who goes to the top of the list; 
where do they go; and what are our plans if this occurs again? 
That is question No. 1.
    Dr. Gellin. You ask all the relevant questions, the same 
questions my mother asked me when she called me from a grocery 
store in Central Connecticut, asking how long the line was 
going to be. As we have highlighted, this is clearly a fragile 
business, and the disappointment we had last year when we lost 
half of our supply forced us to redistribute it.
    I think the good news in that story was when we look back 
over the past year, we found that we actually did a pretty good 
job of getting it to high-risk people, and the messages of if 
you are at lower risk, step aside. I think there were some 
adjustments made to allow that to happen. Clearly, a large part 
of this, as you mention, is about communication, so should 
there be such an issue, it is very clear who is prioritized and 
the need to better communicate with both the health care 
community and the public health community about the 
    So I think that the lesson last year has put that part of 
the operation--which is largely the CDC--in place. At the same 
time, we have regular discussions with the manufacturers along 
the line so we can keep track of where they are in their 
anticipated supply over the year, and have mapped out just a 
few scenarios about how we would adjust things and how priority 
groups might be determined based on those supply situations.
    Ms. Watson. I was quite amazed last year that we didn't 
have a plan in place. What is further amazing me is the reasons 
why--and I think you were addressing those when I walked into 
the hearing--we have not developed the capability in this 
country, why we have not, decades ago, done the research to 
test the flu vaccines, and why we cannot manufacture. I 
understand that it is Canada and Great Britain that do the 
majority. Correct me if I am wrong. But we certainly have the 
ability to do that.
    Is it a misplaced priority? Are we looking at other issues, 
rather than the protection of our people? Flu can kill, and it 
kills tens of thousand annually. And I don't know why we are 
not on top of it. Can someone enlighten me? What did I miss?
    Dr. Gellin. I can't speak to the history, but I can speak 
to the present. I believe that, in point of fact, the largest 
single manufacturer of influenza vaccine in the world is in 
Pennsylvania. There are maybe a dozen or so companies. We have 
one, Sanofi Pasteur, which is based in Pennsylvania, that I 
believe produces the single most influenza vaccine in one 
    Ms. Watson. For our country or others?
    Dr. Gellin. For our country.
    Ms. Watson. Well, what is the problem, why do we run short?
    Dr. Gellin. Well, we have more needs than that one 
manufacturer can make, which gets me to where we are now and 
what we are doing ahead. And I think it was the attention being 
paid to pandemic influenza, or some strategic investments, and 
Dr. LeDuc was mentioning about surge capacity. We have done a 
few things to shore up our supply, particularly with pandemic 
in mind. We have made sure that, in this case, Sanofi, has all 
the eggs that they need 24 hours a day to make as much vaccine 
as they can in a year. That was not a system they had in place 
beforehand. It is a seasonal disease and it is a seasonal 
vaccine, and we filled in that. So should they need, on any day 
of the year, to make vaccine at full capacity, they now have 
the eggs in place to do that.
    But, more importantly, the next step is trying to think 
about the kinds of capacity and the kinds of production 
technologies that may improve where we are. Eggs have served us 
well, but they have some limitations, and we have put 
significant funds to try to accelerate the development of new 
technologies that can allow what we described as surge capacity 
and more vaccine to be produced.
    And, finally, to that point, in addition to developing 
these vaccines, accelerating the development, getting them 
licensed, part of the criteria to this funding stream is to 
develop facilities so that ultimately these new vaccines will 
be produced in the United States.
    Ms. Watson. OK, I am sorry, I am out of time. I was just 
going to join with my friend, Congressman Dan Burton, on the 
mercury issue and the slow movement that has taken place slowly 
in trying to improve.
    So there are other questions, too, but I know I am out of 
time, Mr. Chairman.
    Mr. Shays. Thank you.
    Ms. Watson. Thank you for the time.
    Mr. Shays. We have another that is a rather large panel, so 
we will get to that and just thank all of our witnesses. We 
will be following up with some questions. Mr. Burton may have 
some; I know the committee does. Ambassador Watson may as well, 
and the ranking member and others may. So thank you all very 
    We will announce our second panel. It is Dr. Crosse, 
Director of Health Care Issues, U.S. Government Accountability 
Office; Ms. Selecky, Washington State Secretary of Health, 
testifying on behalf of the Association of State and 
Territorial Health Officials; Dr. Hearne, executive director, 
Trust for America's Health; Dr. John Milligan, executive vice 
president and chief financial officer, Gilead Sciences, Inc.; 
and Mr. Abercrombie, president and chief executive officer, 
Hoffman-La Roche, Inc., accompanied by Dr. Dominick Iacuzio, 
medical director, Roche Laboratories.
    We have enough seats for everyone there? Stay standing, if 
you would, because we are going to swear you in.
    [Witnesses sworn.]
    Mr. Shays. Note for the record our witnesses have responded 
in the affirmative.
    And we will start with you, Dr. Crosse, and we will just go 
right up.
    Dr. Crosse. Thank you.
    Mr. Shays. Five minutes is the time allotted. Obviously, if 
you go over a minute or two, we can live with that. But we have 
a large panel and a busy schedule today. Thank you.
    Dr. Crosse.



    Dr. Crosse. Thank you. I am pleased to be here today as you 
discuss issues regarding our preparedness to respond to an 
influenza pandemic. Shortages of influenza vaccine in the 2004-
2005 influenza season, as well as mounting concern about avian 
influenza activity in Asia, have raised concerns about the 
Nation's preparedness to deal with a pandemic.
    As we have heard, given the global nature of disease, a 
pandemic that begins abroad could quickly spread to this 
    You asked us to provide our perspective on the Nation's 
preparedness for responding to an influenza pandemic, including 
lessons learned from the previous influenza season, that would 
be applicable for pandemic preparedness.
    Although an influenza pandemic will differ from a routine 
influenza season, experience during the 2004-2005 shortage 
illustrates the importance of developing a workable 
distribution plan, identifying priority groups in local 
populations, and developing plans for mass vaccinations in 
    The Nation faces multiple challenges to prepare for and 
respond to an influenza pandemic. Key questions remain about 
the Federal role in purchasing and distributing vaccines during 
a pandemic. HHS's current draft pandemic preparedness plan does 
not establish the actions the Federal Government would take to 
purchase or distribute vaccine during an influenza pandemic, 
and leaves it up to States to select among three options: 
public sector purchase of all pandemic influenza vaccine; a 
mixed public-private system, where public sector supply may be 
targeted to specific priority groups; or maintenance of the 
current, largely private, system.
    However, if States are to purchase vaccine, they may need 
to undertake efforts in advance to establish the necessary 
funding sources, authority, or processes. For example, during 
this past winter, the State of Minnesota tried to sell some of 
its vaccine to other States that needed additional vaccine for 
their high-risk populations. But some States lacked the funding 
or authority under State law to purchase the vaccine when 
Minnesota offered it.
    HHS's draft pandemic plan indicates that, as information 
about virus severity becomes available, recommendations on 
priority groups for early vaccination will be developed at the 
national level. However, during the past vaccination season, in 
some places there was not enough vaccine to cover everyone in 
the priority groups, so States set their own priorities. Maine, 
for example, initially excluded healthcare workers because 
State officials estimated that there was not enough vaccine to 
cover everyone in the nationally designated groups.
    In addition, clear communication will be a big challenge. 
State health officials reported this past winter that mixed 
messages created confusion. For example, when CDC advised those 
persons aged 65 and over to get vaccinated, and some States, 
including California, advised those persons aged 50 and over to 
get vaccinated.
    Further, some individuals found themselves in a 
communication loop that provided no answers on where to be 
vaccinated. CDC advised people to contact their local public 
health department. However, some public health departments told 
callers to contact their physician. But when they called their 
physician, they were told to call their public health 
department. This lack of a reliable source of information led 
to confusion and much frustration.
    Further challenges include ensuring an adequate and timely 
supply of influenza vaccine and antiviral drugs, which can help 
prevent or mitigate the number of influenza-related deaths. As 
we learned this past season, and as we have heard repeatedly 
today, the vaccine supply is fragile; it takes many months to 
produce vaccine; and problems with even a single manufacturer 
can result in vaccine shortages. Particularly given the length 
of time needed to produce vaccines, influenza vaccine may be 
unavailable, in short supply, or delayed, and might not be 
widely available during the initial stages of a pandemic.
    Further, our current stockpile of antiviral drugs is 
insufficient to meet the likely demand in a pandemic. As was 
discussed earlier, HHS is working to expand vaccine production 
capacity and to stockpile vaccine and antiviral drugs, but it 
will be years before these preparations are in place.
    Finally, the lack of sufficient hospital and healthcare 
work force capacity to respond to an infectious disease 
outbreak may also affect response efforts during an influenza 
pandemic. Public health officials we spoke with said that, at a 
minimum, a large-scale outbreak could strain the available 
capacity of hospitals by requiring entire hospital sections, 
along with their staff, to be used as isolation facilities.
    In summary, important challenges remain in the Nation's 
preparedness and response should an influenza pandemic occur in 
the United States. As we learned in the 2004-2005 influenza 
season, when vaccine supply is limited, planning and effective 
communication are critical to ensure timely delivery of vaccine 
to those who need it. HHS's current draft plan lacks some key 
information for planning our Nation's response to a pandemic.
    It is important for the Federal Government and the State to 
work through critical issues, such as how vaccine will be 
purchased, distributed, and administered; which population 
groups are likely to have priority for vaccination; what 
communication strategies are most effective; and how to address 
issues related to vaccine and antiviral supply, and hospital 
and work force capacity before we are in a time of crisis.
    Until key Federal decisions are made, public health 
officials at all levels may find it difficult to plan for an 
influenza pandemic, and the timeliness and adequacy of response 
efforts may be compromised.
    Mr. Chairman, this concludes my prepared statement.
    [The prepared statement of Dr. Crosse follows:]

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    Mr. Shays. Thank you very much for your statement, Dr. 
    Ms. Selecky.

                  STATEMENT OF MARY C. SELECKY

    Ms. Selecky. Thank you, Mr. Chairman and distinguished 
members of the House Government Reform Committee. I am Mary 
Selecky, Washington State Secretary of Health, and I am 
testifying in front of you on behalf of the Association of 
State and Territorial Health Officials [ASTHO]. I would like to 
thank the Chair and the committee for continuing to focus 
attention on our Nation's preparedness levels and our ability 
to respond to a flu pandemic.
    In the last year, my colleagues from Virginia and Arkansas 
have testified before this committee about the challenges 
public health leaders across the Nation faced during this past 
year's flu season.
    My colleagues suggested three actions that the Federal 
Government should consider to avoid a repeat of last year's 
situation: first, the development of a national plan to deal 
with vaccine shortages; second, the establishment of a Vaccine 
for Adults Program; third, the expansion of funding for the 
Centers for Disease Control and Prevention's National 
Immunization Program. These three actions will help ensure that 
all our underserved citizens receive the vaccines they need and 
allow States and localities to enhance adult immunization 
programs. ASTHO continues to strongly urge the Congress and the 
administration to support these efforts.
    I would like to focus my remarks on pandemic flu 
    Lessons learned from last annual influenza season, the 
history of influenza pandemics, and the 2001 anthrax attacks 
continue to underscore the need for public health preparedness. 
Health officials must have overall preparedness plans in place, 
an advanced understanding of our unique role during an 
influenza pandemic, and a knowledge of the resources available 
to help us protect the public. State health officials will be 
looked to as controlling health authorities by Governors, 
legislatures, and the public they all serve. State and local 
health officials will need to assert significant leadership to 
mobilize and sustain private and public healthcare response 
during an influenza pandemic.
    It will take Federal, State, and local public health 
agencies working cooperatively to deal effectively and 
efficiently with a public health concern of this magnitude. To 
date, the collaboration has been good.
    We do remain concerned, however, that public health 
agencies have been asked to take on pandemic flu activities on 
top of existing priorities already established for the 
preparedness cooperative agreements. If the Federal Government 
is truly committed to enhancing our pandemic flu response, we 
need significant increases in resources for State and local 
efforts. All the preventive and therapeutic measures in the 
world are useless without the ability to get them to those who 
desperately need them.
    Development of national guidelines is critically important 
to ensure consistent response. However, they must be flexible 
in order to meet State needs.
    There is already significant work going on. ASTHO, our 
organization, produced in 2002 a preparedness planning for 
State health officials on pandemic influenza. States are 
required to have our pandemic flu plans completed in July 2005, 
and Washington State completed ours in April. This has been 
very difficult because the Federal plan hasn't been completed, 
as you have heard.
    Having a good plan is the first step. But exercising the 
plans to see what works and what needs to be improved is just 
as important.
    In Washington State, we recently conducted a pandemic flu 
tabletop exercise with our neighbors to the north in Vancouver, 
British Columbia. In addition, Public Health Seattle King 
County, our largest local health jurisdiction, held a pandemic 
tabletop exercise with major healthcare facilities in the 
community as well as other county agencies.
    We have unprecedented opportunity to improve the Nation's 
response to flu pandemic. This is an integral part of our 
overall preparedness. It is impossible to predict when a 
pandemic will occur and challenge us. But this is the wrong 
time for the Federal Government to cut State and local 
preparedness funding by $130 million, when we are to address 
this national priority issue.
    States have plans for potential public health threats, 
including pandemic flu. We are exercising those plans. We will 
continue to improve upon them. We are making progress. Are we 
fully prepared? Absolutely not. We are more prepared today than 
we were several years ago, but not prepared enough.
    The new Trust for America's Health report estimates that 
more than half a million Americans may die in a pandemic. Our 
families, our neighbors, and all the people of this country 
expect us to be ready when the time comes. I have no doubt that 
the work we are doing at the State and local level, as well as 
with our Federal colleagues, will help us save lives tomorrow. 
Please help us make sure we have the resources to get the job 
    In closing, let me reiterate four important points: 
pandemic flu preparedness is a critical issue for public health 
to address as part of its overall prevention, detection, and 
response efforts to any natural or terrorist event; 
collaboration among all levels of governmental public health is 
essential; reducing Federal funding for preparedness is exactly 
the wrong thing to do at this time--a sustained Federal 
commitment to preparedness is vital--and progress has been 
made, but there is much more to be done.
    The public health community stands ready to work with you 
to address this threat, but we need your help and support.
    I would be pleased to answer any questions you might have. 
Thank you, Mr. Chairman.
    [The prepared statement of Ms. Selecky follows:]

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    Chairman Tom Davis. Thank you very much.
    Dr. Hearne. Thanks for being with us.


    Dr. Hearne. Thank you. Mr. Chairman and members of the 
committee, thanks for this opportunity to present our views on 
    Let me just say thank you again for being here to present 
our views on the potentials of what a deadly and massive novel 
virus could do if it hit this country. As a national 
organization that is dedicated to preventing epidemics and 
protecting people, Trust for America's Health provides the 
independent oversight on our Nation's public health system, 
that is, the front lines in a pandemic.
    What we have been talking about here today is that a 
pandemic is actually potentially even more threatening than 
bioterrorism attacks, and worse is experts believe it is 
inevitable. Yet, what we do know is that with proactive 
coordinated actions, this Nation could be taking lifesaving 
efforts today to mitigate the devastating impact.
    What I would like to do is submit for the record our just-
released report ``The Killer Flu?'' What this report does is 
provide a State-by-State examination of how many people may 
die, how many may be hospitalized during a pandemic. It also 
includes a review of the United States and State preparedness, 
and a series of recommendations for improving readiness.
    Chairman Tom Davis. And, without objection, that will be 
put in the record.
    [Note.--The information referred to is on file with the 
    Dr. Hearne. Thank you, Mr. Chairman.
    Let me summarize. That report finds that there is a failure 
to establish a cohesive, rapid, and, most importantly, 
transparent U.S. pandemic strategy, which puts Americans 
needlessly at risk. I would like to highlight three 
shortcomings for you and offer some concrete suggestions on how 
we can actually improve the Nation's response capacity.
    First, a final and operational pandemic plan must become a 
priority for this administration. The good news is, as was 
discussed, HHS has released a draft plan last August. Bad news 
is it is draft and with no formal deadline for completion. TFAH 
has actually reviewed the majority of State pandemic plans and 
found widely different stages of readiness.
    It is no surprise, as we have discussed, since there isn't 
Federal guidance out there. What we have found is that most of 
these plans are simply plans for plans. Some States are not 
making those plans public, which many experts believe is going 
to harm our ability to fully integrate and create trust with 
the public, healthcare providers, and the critical first 
responders that would be part of a pandemic response.
    To ensure nationwide preparedness standards and to 
facilitate a regional coordination, much like what Ms. Selecky 
was talking about, we need to have CDC formally reviewing and 
approving all State plans, and to require that these are public 
documents. All these plans must have greater specificity, which 
also was discussed in terms of things like who are the high 
priority populations that would get the limited medicines and 
vaccines during a pandemic. Is it the healthcare workers and 
their families, utility operators, police, firemen?
    These are the kinds of issues that we need to determine 
prior to an outbreak, not in the midst of crisis. Last year's 
flu vaccine shortage was an ugly glimpse into the lack of 
planning and preparedness.
    And the Federal pandemic plan cannot just be a game plan 
for the health world. Unlike other nations, the United States 
does not appear to have assessed or planned how a pandemic 
would actually disrupt the economy and society with potential 
school and workplace closures and travel restrictions. The 
President should designate a senior official--you should have 
an answer when you ask who is in charge--that is responsible 
for ensuring that cabinet level coordination of the Federal 
Government's response to a pandemic.
    The second issue I want to touch on is getting this Nation 
positioned to rapidly provide vaccines to all Americans. We are 
behind the eight ball because of our Nation's limited and 
antiquated capacity. Most experts estimate on the extensive lag 
time that would be existing for getting vaccines. First thing 
we should be thinking about: the FDA needs to immediately begin 
work with potential manufacturers of a vaccine to develop in 
advance the criteria for a rapid response approval.
    We are also concerned about the U.S. domestic production 
capacity. With a projected stockpile of 40 million doses as a 
start, we need to be able to vaccinate the entire U.S. 
population. What HHS should be doing is investigating the value 
of creating a reserve manufacturing capacity here in the United 
States, similar to what Canada has done. This would be 
especially important if the pandemic is not this avian flu, 
which means that the current stockpile that we have of H5N1 
would be ineffective.
    Third, we need to assure that our stockpile of medical 
supplies and medicines--which many of these are being produced 
overseas, and with a healthcare system that relies on a ``just 
in time'' inventory--we need to be looking at how to make sure 
the stockpile is built faster and is large enough to cover us 
in the time of need.
    For example, the United States is very late and very short 
in purchasing significant quantities of Tamiflu. Other 
countries have followed the who estimates of a pandemic 
effecting at least 25 percent of the population, and they have 
ordered that much. The United States is somewhere below 2 
    Vaccines and antivirals are not the only stockpile needs. 
We need to be talking about ventilators, masks, vaccines, even 
the vaccine injection devices that were brought up earlier.
    We are also deeply concerned about the current licensing 
dispute that is going on between Gilead and Roche, and making 
sure that this does not result in a reduction of the production 
of Tamiflu. We urge the administration to aggressively step in 
and work with these companies to make sure current capacity is 
maintained and that we actually increase domestic operations in 
the immediate future.
    The administration and Congress must find the sufficient 
funding in the coming years to increase the stockpiles and 
create incentives for U.S.-based production. But I cannot 
emphasize more strongly enough the point that ASTHO and others 
have raised, that these pandemic activities need to be 
supported at all levels, but not come at the expense of other 
preparedness efforts. The Nation's stockpile, the preparedness 
activities, the bioterrorism readiness, these have to be done 
in a fully integrated fashion, not in separate silos and not 
syphoning off dollars to take care of each other.
    In summary, there are several steps that we need to take 
today to improve readiness. It can't be a paper chase, it needs 
to be a priority. Thank you for the time.
    [The prepared statement of Dr. Hearne follows:]

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    Chairman Tom Davis. Thank you very much.
    Dr. Milligan, thank you for being with us.


    Dr. Milligan. Mr. Chairman, Congressman Waxman, and 
committee members, thank you for the invitation to present here 
today. I am John Milligan, executive vice president and CFO of 
Gilead Sciences. By way of background, I am a Ph.D. biochemist, 
and I was a project team leader for the development of Tamiflu 
by Gilead.
    Gilead is a biopharmaceutical company headquartered in 
Foster City, CA, the district of Congressman Tom Lantos. We 
also have research facilities in Durham, NC; a manufacturing 
facility in San Dimas, CA; and overseas offices throughout 
Europe and Australia.
    Since Gilead was founded nearly 20 years ago, the company 
has focused on advancing the care of patients suffering from 
life-threatening diseases. Over the course of our company's 
history, Gilead has successfully developed, commercialized, and 
ensured broad access to a portfolio of antiviral medicines in 
HIV and hepatitis.
    Today, these important antivirals are improving the quality 
of life for patients around the globe. Gilead does not achieve 
this alone, but through a strong commitment to collaboration, 
working in partnership within our industry, with governments, 
with healthcare professionals, and with nongovernmental 
    As you know, Gilead is the inventor of Tamiflu, or 
oseltamivir phosphate. Tamiflu is the first and only antiviral 
pill available for the treatment and prevention of all common 
strains of influenza A and B. The compound was shown to be 
active in animal models against avian flu, also known as H5N1 
strain of the virus. Tamiflu was discovered by Gilead 
scientists in 1996, and Gilead conducted all the initial 
characterization of the compound and developed the 
manufacturing process for the product.
    Also in 1996, Gilead entered into an exclusive agreement 
with F. Hoffman-La Roche of Basel, Switzerland, providing for 
the development and commercialization of Tamiflu worldwide. 
According to the agreement's terms, Gilead and La Roche 
collaborated on Tamiflu's clinical development, with Gilead 
successfully managing three out of the four registrational 
trials leading to FDA approval. Since the U.S. product launch 
in late 1999, however, La Roche has been solely responsible at 
its own expense for product commercialization, including 
manufacturing, marketing, and distribution ``in substantially 
all markets of the world.''
    While vaccination is the primary weapon in combating 
influenza, we believe Tamiflu is a key component in addressing 
the potentially devastating impact of the disease. The role of 
Tamiflu must be better recognized, not just for pandemic 
planning, but also for seasonal influenza outbreaks. It bears 
emphasis that Tamiflu is not just effective for treatment of 
influenza, but also effective for influenza prophylactic, 
meaning it can prevent transmission of the virus.
    Since at least 2001, we believe that our partner Roche has 
neither demonstrated acceptable commitment nor dedicated 
adequate resources to Tamiflu.
    Chairman Tom Davis. Dr. Milligan, we are really not 
interested in the corporate disputes. If we could move on. We 
are really interested in your product, and the fact that you 
and Roche can work out your problems and make sure that we get 
this to market.
    Dr. Milligan. I agree. At the heart of this, this is a 
commercial issue between the two companies, and not an action 
that we take lightly. I want to underscore an important point, 
which is that this action will not affect current arrangements 
or planning for the manufacture and supply of Tamiflu.
    Roche is responsible, and will be responsible, for ongoing 
manufacturing, until time such time as the termination of the 
agreement becomes effective. The agreement also explicitly 
provides that in the event of termination, Roche must continue 
to supply product for up to 2 years and must transfer necessary 
manufacturing technology to Gilead.
    Consequently, Gilead anticipates a coordinated and orderly 
process for the transfer of manufacturing, should termination 
occur. During any period of transition thereafter, Gilead will 
honor the supply obligations undertaken by Roche.
    I would like to be especially clear about Gilead's 
commitment to advancing the care of patients suffering from 
diseases. In the mid and late-1990's, Gilead conducted 
extensive research on oral neuraminidase inhibitors, the class 
of drug to which Tamiflu belongs. We moved Tamiflu into 
clinical evaluation because, among the compounds we tested, it 
had the best potential safety and efficacy profile.
    In accordance with our 1996 contract with Roche, Gilead 
continued to conduct extensive research into various compounds 
that showed activity against influenza A and B. Many structural 
classes were identified; however, none of these were thought to 
have better properties than Tamiflu, and none are currently 
being pursued as viable options for the treatment and 
prevention of influenza. Any of these compounds would be 
included in the 1996 agreement between Gilead and Roche, and 
Gilead would not be free to pursue any of these on its own.
    I also want to highlight that Gilead is a leader in the 
manufacturing of antiviral medicines at large scales. Our 
expertise drawn from experience with HIV therapeutics is highly 
relevant to the situation surrounding the influenza pandemic. 
Gilead has and is continuing to manage the manufacturing of our 
HIV products in amounts that well exceed 2004 and anticipated 
2005 production volumes for Tamiflu.
    Comparable to the unpredictability of flu pandemics, the 
rapidly growing global HIV epidemic has required a carefully 
structured manufacturing plan for antiretrovirals, in absence 
of accurate forecasts estimating the number of patients to be 
treated for HIV resource-limited countries for years to come. 
Further, before issuing the notice of termination, Gilead 
conducted a thorough internal assessment of our capabilities. 
We determined that we can meet the global pandemic and seasonal 
needs for Tamiflu and make significant contributions in 
advancing manufacturing, supply, and medical education for this 
important antiviral medicine.
    At Gilead, we believe that important lessons can be learned 
from previous annual influenza seasons, particularly with 
regard to the administration of Tamiflu. If the effort is made 
to study the facts and data available to us, and to engage with 
leaders in global public health, these lessons can and should 
be applied to enhance responses to both seasonal and pandemic 
    For instance, much attention has been drawn to the fact 
that in order to be most effective for combating influenza, 
Tamiflu must be taken within 48 hours of exposure to the virus. 
It is true that this 48-hour window is absolutely critical to 
ensure better outcomes for the infected individuals and the 
existence of this window highlights the importance of advancing 
education, securing supply, and breaking down the barriers to 
rapid access to the product. In order to underscore this 
crucial point, I have made available to the members of the 
committee a paper published by the Journal of Antimicrobial 
Chemotherapy on the benefits of early administration of 
    Our role, should Tamiflu rights be returned to Gilead, will 
be one of planning and partnership. We believe there is an 
urgent need for increased education about and access to 
Tamiflu, not only for pandemic purposes, but as importantly for 
seasonal influenza.
    Gilead looks forward to establishing partnerships with the 
distinguished committee members and government agency 
representatives here today, and with governments and public 
health officials around the world. We are prepared to enter 
into constructive dialog about the important role of Tamiflu in 
global public health, which we intend to fully support with 
appropriate, constructive action. Thank you.
    [The prepared statement of Mr. Milligan follows:]

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    Chairman Tom Davis. Thank you. Thank you very much.
    Mr. Abercrombie.


    Mr. Abercrombie. Good morning. Good morning, Mr. Chairman 
and members of the committee. I am George Abercrombie, 
president and chief executive officer of Hoffman-La Roche, a 
research-based pharmaceutical company. I am accompanied today 
by Dr. Dominick Iacuzio, our medical director for Tamiflu. I 
want to thank you for the opportunity to discuss the role of 
Roche and the antiviral drug Tamiflu in pandemic influenza 
preparedness and response, and I request that my full written 
testimony be submitted for the record.
    Chairman Tom Davis. Without objection, everybody's full 
written testimony is in the record.
    Mr. Abercrombie. Since Roche licensed Tamiflu nearly 10 
years ago, we have acted in a responsible manner, consistent 
with the public health role of this wonderful product and our 
commercial obligations. Roche remains committed to ensuring the 
availability of Tamiflu to patients and governments around the 
world, and we are optimistic that this unfortunate matter with 
Gilead will be resolved.
    Let me now turn to the central office of this hearing, and 
that pandemic influenza, which is one of our greatest public 
health threats.
    According to the Department of Homeland Security, the 
potential consequences of even a limited influenza pandemic 
could result in economic disruption, hospitalizations and 
deaths far in excess of most terror attacks. It is widely 
recognized that Tamiflu is critical and a critical tool in 
pandemic influenza preparedness. The Infectious Diseases 
Society of America has recommended that the U.S. stockpiles 
enough antivirals to treat up to 50 percent of the population.
    Based on Roche's commitment to the product, Tamiflu is the 
leading prescription antiviral medication for the treatment of 
influenza type A and B in patients 1 year and older, and 
prevention of influenza type A and B in patients 13 and older. 
Data to support prophylactic use in children 1 year of age and 
older were recently submitted to FDA for review.
    The efficacy of Tamiflu against avian influenza has been 
demonstrated by leading researchers and animal studies and in 
vitro data, and is supported by practical experience during a 
2003 avian influenza outbreak in the Netherlands. In contrast 
to an antiviral drug requiring inhalation, orally ingested 
Tamiflu has been shown to be systemically active in humans. 
This is important because evidence derived from infected humans 
and animals suggests significant systemic involvement of the 
H5N1 avian virus.
    Although the potential for resistance must be monitored 
carefully, no transmission of a Tamiflu-resistant virus in 
humans has been detected to date. Accordingly, the World Health 
Organization has recommended the use of Tamiflu to help control 
the avian flu outbreaks in Asia.
    Roche continues to work closely with public health 
officials, physicians, and other healthcare professionals 
around the world in a manner that is responsible and 
complimentary to seasonal flu vaccination programs. We have 
recommended against, and do not advocate for, indiscriminate 
uses which could lead to resistance, such as the prophylactic 
veterinary use of amantadine, recently reported in Asia.
    Given inherent complexities in Tamiflu production, surge 
capacity to meet immediate, large-scale demand upon the 
outbreak of a pandemic, simply does not and cannot exist. The 
manufacturing process for Tamiflu takes 8 to 12 months from raw 
materials to finished product. The process involves many inputs 
and steps, including a unique starting material and a 
potentially explosive production step that can be carried out 
only in specialized and very costly facilities. Despite these 
limitations, since 2003, we are increasing total Tamiflu 
production capacity nearly eight-fold.
    At the request of the U.S. Government, Roche has developed 
a new U.S.-based supply chain that will be launched in the 
third quarter of this year. Further, we have developed special 
U.S. packaging for stockpiled Tamiflu to extend the shelf life 
and ease distribution and administration. In addition, Roche 
has also discovered and developed a synthetic process for 
manufacturing the chemical used in the initial production step. 
This will ultimately reduce reliance on natural sources.
    Roche has received and is filling on schedule pandemic 
stockpile orders for Tamiflu from 25 countries, and we have 
received letters of intent from five additional governments. 
Countries such as the United Kingdom, France, Finland, Norway, 
Switzerland, and New Zealand are ordering enough Tamiflu to 
cover between 20 and 40 percent of their populations. And just 
this morning the country of Portugal announced an order for 25 
percent of their population.
    Although discussions are underway with the U.S. Government 
to purchase significantly greater amounts of Tamiflu, achieving 
domestic stockpile levels comparable to other nations will 
require firm, sustained commitments from the U.S. Government.
    If I can leave you with three messages, they are the 
following: first, there is a consensus by global health 
authorities that Tamiflu is an important tool in pandemic 
influenza preparedness and response; second, other nations are 
currently well ahead of the United States in Tamiflu 
stockpiling. We urge the United States to make expanded 
commitments now and over time to ensure an adequate Tamiflu 
    Finally, I want you to know, Mr. Chairman and this 
committee, that the availability of Tamiflu as a part of a 
robust pandemic response remains my top priority as chief 
executive officer of Hoffman-La Roche.
    On behalf of Roche, thank you for highlighting this 
critical public health issue. And Dr. Iacuzio and I will be 
pleased to answer any questions you may have.
    [The prepared statement of Mr. Abercrombie follows:]

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    Chairman Tom Davis. Well, I thank all of you for your 
testimony. As I noted, your entire testimony is in the record, 
and questions will be based on that. Let me start off.
    Dr. Milligan, let me start with you. In your opinion, has 
the United States stockpiled a sufficient amount of Tamiflu to 
prepare against the threat of a flu pandemic?
    Dr. Milligan. If you compare the United States to 
governments around the world, it is woefully inadequate and way 
below the levels that would be recommended by not only U.S. 
health authorities, but by world health authorities. So I 
believe it is far too low.
    Chairman Tom Davis. If something were to occur here, how 
quickly could we be able to get this out to the population? If 
the United States were to come in and order millions of more 
doses tomorrow, how quickly would it be before they could 
receive it? I will ask either you or Mr. Abercrombie, if there 
is a consensus there.
    Mr. Abercrombie. Well, as I stated, Mr. Chairman, it takes 
8 to 12 months to manufacture Tamiflu. It is a very complex 
multi-step process involving, at one step, potentially 
explosive material. We have done everything we can to 
accelerate that process; we have increased production capacity 
eight-fold. So we cannot rely on the ability to flip a switch 
and suddenly make large quantities in the event that a pandemic 
breaks out. That is why it is crucial to stockpile large 
quantities well in advance of a pandemic.
    Chairman Tom Davis. Do you agree with that, Dr. Milligan?
    Dr. Milligan. I actually disagree with that, because you 
can in fact stockpile large amounts of the active 
pharmaceutical ingredient. So you can stockpile significant 
amounts, and this stores virtually indefinitely at refrigerated 
    Chairman Tom Davis. So the ingredients you can store 
    Dr. Milligan. The ingredients you can store. The rate-
limiting step, then, becomes the capsuling process. And that 
would require significant orders from governments in order to 
fill those, because once you make a capsule, it starts to 
    Chairman Tom Davis. How long does it take to capsulize it, 
is that pretty quick?
    Dr. Milligan. Depends on how many production lines you have 
and your commitment to that. Making an individual capsule is 
very fast, but making tens of millions or hundreds of millions 
would require multiple production lines.
    Chairman Tom Davis. Yes, Mr. Abercrombie.
    Mr. Abercrombie. If I can just respond to that. In fact, we 
do store large quantities of the raw materials, predominantly 
here in the United States, because the United States is the 
primary site of moving those materials into finished product. 
And even by storing large materials, it is about a 6-month 
process before you can, from that point, have finished material 
on the marketplace.
    Chairman Tom Davis. The shelf life is what, at least 5 
    Mr. Abercrombie. The approved shelf life is currently 5 
years. We have worked with the Government to extend the shelf 
life. The Government is working with the strategic national 
stockpile to determine if that can be extended in the event of 
a security problem with a pandemic.
    Chairman Tom Davis. You heard our first panel basically say 
that we need to have more of this. This is the stopgap until 
you develop your vaccine. OK.
    Dr. Crosse, the GAO has previously reported that regional 
planning between States is inadequate to respond to 
bioterrorist attacks. The response to an infectious disease 
such as influenza is very similar to bioterrorism. Did we see 
effective regional cooperation and information sharing during 
the flu vaccine shortage last fall?
    Dr. Crosse. We saw some. I think that there are some 
established networks that were already in place. I think that 
has increased. Last year, however, it was primarily something 
that was centralized with CDC, so there was much greater 
centralized control of the distribution once the shortage was 
identified. I think that we did see some cooperation. Minnesota 
already heads a multi-State purchasing cooperative for the 
purchase of influenza vaccine, so that is some regional 
cooperation that already exists. Dr. Selecky talked a little 
bit about some regional activities in the Northwest. But it is 
not something that is true in every part of this country.
    Chairman Tom Davis. What States were most successful in 
dealing with last season's flu vaccine shortage?
    Dr. Crosse. Well, in part it was States that had ordered 
from Santa Fe, and so they were fortunate in that their 
supplies were not as limited. But also it was States, I think, 
who had done more prior planning.
    In particular, we saw success in Minnesota, which had an 
adequate supply and, in fact, had enough vaccine that they were 
able to offer vaccine to other States. California had a pretty 
high success rate in reaching populations. Some other States, 
though, had much more difficulty. Both Maine and Florida, among 
the States that we visited, had a lot of difficulty in covering 
their high-risk populations and did not have the same sort of 
vaccination rates that they had hoped to achieve.
    Chairman Tom Davis. Dr. Selecky, during last year's flu 
vaccine shortage, some States ended up having adequate supplies 
of vaccine to meet the demand from high-risk groups, and were 
even able to offer vaccine to some lower risk. Other States 
couldn't even meet the demands of the high-risk groups. Now, 
Chiron has recently announced that their production rates may 
be short again this year. Better than last year's, but be short 
of what they had hoped.
    Does ASTHO have recommendations about how distribution 
among the States might be more evenly achieved?
    Ms. Selecky. Actually, ASTHO would recommend that Centers 
for Disease Control and the Federal Government bring us into 
the discussions as quickly as they know that there could be a 
shortage. Last year I think we were all caught off guard on 
October 5th, when we learned that we lost one of our 
manufacturers. And we weren't quite ready to address the 
question that was immediate from the public: Where can I get 
mine today? Will it come to my community?
    When we did engage with the Centers for Disease Control, 
who needed to work with the private manufacturers, I think that 
is one of the issues that we face in this country; we have a 
private supply, a privately delivered product, but a public 
demand and a public need. And I think that is what is certainly 
behind the ASTHO recommendation that we need a national adult 
immunization policy in this country; we need to have 
incentives, as we mentioned before, for vaccine manufacturing.
    The States are ready to move into that action. Guidance 
from the Federal Government is essential. A common message to 
the public is very important. But particularly for those of us 
at States, we had a sub-rosa network that was about finding out 
who needed, who had, how we could get it across lines, as it 
were, because we don't control the sales, either, to release 
from our States. In the Northwest we paid attention to what 
recommendations by what age that we would be giving the 
vaccine, so that we didn't confuse our public who hears the 
same media.
    There is clearly work to be done, and I would suggest that 
the Centers for Disease Control start working with us now about 
that potential.
    Chairman Tom Davis. Thank you. Thank you very much.
    Mr. Burton.
    Mr. Burton. Thank you, Mr. Chairman.
    Mr. Abercrombie, do they produce Tamiflu in Indianapolis? 
Is that your plant that you do production of that?
    Mr. Abercrombie. No, sir. The Indianapolis plant is from 
our Diagnostics Division. We have Tamiflu production scattered 
across other States in the United States, including New Jersey, 
South Carolina, North Carolina, California, and Boulder, CO.
    Mr. Burton. OK. Your headquarters is there, though.
    Mr. Abercrombie. Headquarters for the Diagnostics Division 
is in Indianapolis.
    Mr. Burton. Is that where you are located?
    Mr. Abercrombie. I am located in Nutley, NJ. Pharmaceutical 
Division is different from the Diagnostics Division.
    Mr. Burton. You need to move to Indiana; it is a great 
    Mr. Abercrombie. I visit there often.
    Mr. Burton. Good.
    I think Mr. Milligan indicated--and I understand you guys 
have a little difference of opinion right now--that you could 
open up more production lines in order to speed up the 
production and get more on the shelf quicker. Because the 
possibility of a pandemic does exist, have you considered that, 
or is your company considering opening up more production lines 
to meet the potential demand for this?
    Mr. Abercrombie. Yes, sir. In fact, since 2003 we have 
increased the global production capacity eight-fold. We 
continue to work 24/7 to do so. At the request of the 
Department of Health and Human Services, we have building, have 
completed a supply chain dedicated right here on U.S. soil that 
we expect approval from the FDA in the third quarter.
    The real issue, sir, is not capacity from a U.S. 
perspective; it is we need firm orders. We are fulfilling 
orders around the world on a first come, first serve basis, and 
the United States is woefully behind the other countries I 
mentioned in my testimony in providing orders. But the answer 
is we will provide whatever capacity is necessary to meet 
global demand for a pandemic. We have and will continue to do 
    Mr. Burton. Let me make sure I have this straight. You 
could probably meet the demand that is necessary to protect a 
large segment of the American population if our health agencies 
gave you the order to go ahead and produce the product.
    Mr. Abercrombie. If we had received a substantial order 
merely a year ago, sir, we could have delivered tens of 
millions of courses of therapy this year. Unfortunately, other 
countries have gotten in line ahead of the United States.
    Mr. Burton. Have our health agencies given you any reason 
why they have not placed the orders?
    Mr. Abercrombie. I can tell you, sir, that me, personally, 
and other people from Roche have met with senior officials at 
HHS, CDC, other Members of Congress, and they all agree we need 
a stockpile, as you heard from the first panel. But I cannot 
answer why the large order commitment has not yet come.
    Mr. Burton. Mr. Chairman, I would suggest that maybe it 
would be a good idea for you and the vice chairman and myself 
and others to sign a letter to our health agencies, HHS, and 
ask them why they haven't put in a request or an order for an 
adequate supply of this. If the risk is as great as it appears 
to be, and it is uncertain as to when this problem might occur, 
it seems to me that we ought to be prepared for it. And I would 
like to join with you, if you see fit, to send a letter of 
inquiry over there.
    Chairman Tom Davis. Well, I think we will do that. With a 
5-year shelf life, I just think that it makes a lot of sense. 
And if you heard from the first panel as well, from Federal 
experts, they seem to agree with that, Mr. Burton. So we will 
try to do that.
    Mr. Burton. I would be happy to join you in that, Mr. 
    Chairman Tom Davis. That would be great.
    Dr. Iacuzio.
    Dr. Iacuzio. Excuse me. I just wanted to add right now we 
have FDA approved 5-year shelf life. But there is all 
indication by our chemists that the product is stable longer. 
And with this shelf life extension program, it could go beyond.
    Chairman Tom Davis. And it can be used for other strains of 
    Dr. Iacuzio. Yes.
    Chairman Tom Davis. Like for last year we could have used 
    Mr. Burton. Mr. Chairman, I have no more questions. I just 
think that would be a little stimulus to our health agencies to 
get on the ball and make sure that we place the order so we 
will be adequately protected. Thank you, Mr. Chairman.
    Chairman Tom Davis. Thank you very much.
    Mr. Shays.
    Mr. Shays. Thank you.
    Dr. Crosse, it is a bit reassuring that other States have 
further developed important aspects of public health 
preparedness. However, it is a concern to know that we still 
have a lot of work left. And I am not clear as to where the 
areas of work are.
    Dr. Crosse. I think there are a number of areas of work. 
One of the ones we highlighted today is in planning to deal 
with any large-scale infectious disease outbreak, be it 
pandemic influenza or any other emerging infectious disease in 
terms of the hospital capacity and the healthcare work force 
capacity. This is something that there has been a stream of 
Federal funding to assist in that effort, but it is still not 
adequate to deal with a kind of pandemic situation where we 
believe that hospitals would be overwhelmed.
    The other efforts that have benefited from some funding 
from the Federal Government are in planning for infectious 
disease outbreaks. There has been some planning at the local 
level on how to run mass immunization campaigns, but we 
realized this past winter that there are still many locations 
that were not set up or not staffed, or had not yet determined 
how they could run through the public health department a mass 
immunization effort. That was something that was supposed to 
have been worked out when they were working on small pox 
vaccination campaign, but we realized that there are still 
communities where this is a major challenge.
    Mr. Shays. Ms. Selecky, has the dissemination of critical 
information during previous flu seasons to State and local 
government officials and health institutions been adequate, and 
how could it be improved?
    Ms. Selecky. The Centers for Disease Control is just 
completing a round of regional meetings with all of us in the 
States to learn the lessons from the past and to prepare in 
better ways for the future. So work continues to be done on 
that. There is always something new to learn, and whether it is 
our State plan, it needs to be exercised and then revised.
    And to pick up on a point made by Dr. Crosse, in the tri-
cities area, where Hanford is, actually, the local health 
department was the only provider of flu vaccine in the 
community, in 3 days gave out the 10,000 doses they were lucky 
to have, on October 7th, 8th, and 9th, using mass vaccination 
and the plans that we had for any kind of mass vaccination. The 
State of Arkansas did much the same.
    We continue to learn from those, but as I expressed in my 
testimony, we are quite concerned that we get additional 
priorities placed on us for use of the cooperative agreement 
for preparedness, including the pandemic flu planning at, 
though, an Administrative decision for a reduction. Clearly, 
the pandemic flu planning is absolutely essential for the 
protection of our general public.
    Mr. Shays. I am not quite clear what kind of guidance is 
being provided by the Federal agencies and to State and local 
officials to help prepare them to handle a significant 
outbreak. So let me ask you this. How has the Federal 
Government supplemented your response efforts in handling the 
various public health threats that have surfaced in your 
    Ms. Selecky. Clearly, the work that has been done around 
the strategic national stockpile is work that is new over the 
last several years of public health preparedness, and 
particularly with all the emphases since 2001. So the fact that 
there is stockpiling going on, the number of stockpiles 
available to the Nation have increased, the practice that we do 
with our Federal partners on that distribution is additional 
    We are all waiting for the next draft of the Federal 
pandemic flu plan so that we can revise our State plans as 
appropriate. But States have not sat back and just waited for 
that to come out. So that is one where there is a pull me, push 
me relationship going on, clearly.
    The work that is done with our epidemiologists in our 
laboratories, being able to do surveillance and identify flu, 
has definitely increased. However, we continue to be at the 
mercy of what is in the stockpile, what is purchased, and that 
is clearly a Federal asset and not a State or local asset.
    Mr. Shays. Thank you.
    Dr. Hearne, we have heard that some States are experiencing 
a shortage of trained public health specialists and 
epidemiologists. How serious is this crisis? First, is it a 
crisis? And, if so, how serious is it? And what steps can and 
should be taken to improve training for healthcare workers?
    Dr. Hearne. Across the board we have found--whether it is 
epidemiologists, lab scientists, even some of the critical 
environmental scientists who would respond in a chemical 
bioterrorist event--there are huge work force shortages. It is 
perhaps one of the greatest problems facing our public health 
systems from State to State. A report that we put out last 
year, ``Ready or Not,'' identified those gaps and identified 
some of the recommendations to go forward with this.
    I think it is an area that must be significantly addressed, 
particularly as we are talking about beefing up the stockpile, 
getting supplies. You need to have those front line forces who 
would do the distribution of those materials, or rapidly 
identify an outbreak and hopefully contain it before you even 
need those materials. That is, first and foremost, job No. 1 
that we need to focus on with public health.
    Mr. Shays. Let me ask you has vaccination as a primary 
strategy for protecting individuals who are at greatest risk 
contributed to the lack of antiviral production capacity in the 
United States?
    Dr. Hearne. With antiviral or vaccine? I am sorry.
    Mr. Shays. Antiviral.
    Dr. Hearne. One of the issues is--as we have been looking 
at just stockpiling--this is a very new effort that has been 
ramped up in just recent years since September 11th. We have 
recognized that we have critical materials missing. Antivirals 
have not been the top priority, but it is now bouncing up to 
the top as we are starting to recognize the seriousness and 
potential severity of a pandemic.
    Mr. Shays. So the question, though, as we are looking to 
protect the folks at the greatest risk, has that impacted our 
    And I will allow others to respond.
    In other words, we don't stockpile it, we are out there 
using it in anticipation because they are at risk, correct?
    Dr. Hearne. Well, one of the lessons we learned from the 
previous shortage in the flu vaccine is that we didn't have 
those distribution systems in place. We had challenges of 
identifying who was even most at high-risk, how to get them out 
there, and how to assure that. This is, again, a balancing act 
of making sure that we are creating sufficient demand for 
materials so that we can have either ready-to-use materials and 
also stockpiles, and the distribution mechanisms to effectively 
reach those most at need.
    Mr. Shays. The staff would like this question asked of 
Roche. The CDC conducts a strong flu vaccine campaign in the 
early fall of every year. Does Roche actively market Tamiflu 
during this time? How does Roche's marketing strategy 
compliment CDC's strong immunization method? And do you believe 
that heavier marketing by Roche during the annual flu season 
could have increased demand and production capabilities for 
Tamiflu over the years?
    Mr. Abercrombie. Since launching Tamiflu, we have acted 
responsibly to ensure that we convey to physicians the role of 
both vaccines and Tamiflu. We encourage that all patients who 
need to be vaccinated be vaccinated. There is clearly a role 
for vaccines. And then there is a role for Tamiflu, in case you 
are infected with influenza. We usually, including last season, 
actually disseminate the CDC guidelines so that we are very 
transparent and up-front with that. We do not want to 
indiscriminately advocate Tamiflu use, we want to make sure it 
is used consistent with the guidelines. And there is a role for 
both in normal influenza, as well as a pandemic.
    Mr. Shays. Let me ask is there any question that you all 
want to put on the record? In other words, do you want to ask 
yourself a question that you can then answer to put on the 
record? Is there anything that the record would be incomplete 
without that answer being asked? It is a serious question to 
ask, it is usually my best question.
    Yes, Ms. Selecky.
    Ms. Selecky. I would have you ask me the question as to 
what intervention States are prepared to take should we be 
faced with pandemic flu.
    Mr. Shays. That is a great question. Why don't you answer 
    Ms. Selecky. And, if so, I think what we have to do is 
absolutely look at it as a comprehensive approach. Yes, 
antivirals are important. Yes, vaccine and routine every-year 
vaccine is essential. But we must be able to do the enhanced 
disease surveillance. I recently was at a global health summit 
in the Pacific Northwest with 16 countries from the Pacific Rim 
who were represented, including those countries that have avian 
influenza in human populations. The head of the World Health 
Organization and all of the leading medical and governmental 
folks from those countries said you must have public health 
infrastructure in place if we are going to even think about 
addressing a pandemic of the proportion we are all concerned 
    So it is about surveillance, it is about your State and 
local public health system. It is also about community 
containment strategies, making sure we use things like 
quarantine and isolation appropriately, or simple things like 
cover your mouth or stay home, those basic public health 
    A third would be antivirals; a fourth would be vaccine; and 
clearly the issue of healthcare system surge planning. We must 
be at the table with our hospital partners. We must understand 
that we may stop certain activities if we were ever hit with a 
pandemic. But we have all got to deal with--every one of us, 
State, Federal, local--good and important risk communication. 
The public expects to tell them what they know in a way that 
they can figure out how to protect themselves and their 
    Thank you.
    Mr. Shays. Thank you. Thank you for that question and thank 
you for that answer.
    Is there any other question that you need to ask yourselves 
here? Anyone else want to put anything else in the record?
    [No response.]
    Mr. Shays. Well, let me just thank you. Let me just ask 
this last question. What country does this the best, protects 
the public the best? Who would be the best model around the 
world? And if you choose a country, tell me why. Ms. Selecky?
    Ms. Selecky. Well, I will venture a guess. And it is only 
because of our recent experience with British Columbia. Because 
we are both a State and a province that have such international 
trade from the east. And what we look at is the systems are so 
different. When I sit with my colleagues from Canada and 
understand that the healthcare system is the governmental 
system, and that a singular decision is then carried out in a 
way that is very different with the suasion that we have to do 
with our private partners, the private suppliers, etc.
    It is a very different system. So I am not sure it is 
better, but, indeed, when they were facing.
    Mr. Shays. When it comes to dealing with an epidemic, a 
pandemic, they may be better able to deal with it, given that 
they have a more public process throughout?
    Ms. Selecky. They are easier to get a common decision 
through a number of partners, where I, as a State health 
official, need to work with my public and private hospital 
systems and convince them. They do it with us.
    Mr. Shays. It just triggers a reaction from me. We are not 
going to see that system in the United States, so it is 
incumbent on all of us to find a way that we make the private 
and public sector work better. And giving better direction to 
the private sector, providing financial incentives, dealing 
with some risk that you encounter, all of that, it seems to me, 
will play a role in our providing a better service.
    So let me end with that, if I could, and thank you all for 
this hearing. Thank you for being here. Thank you for helping 
your country do a better job.
    With that, we will adjourn this hearing.
    [Whereupon, at 12:38 p.m., the committee was adjourned.]
    [Note.--The Association of State and Territorial Health 
Officials November 2002 report entitled, ``Preparedness 
Planning for State Health Officials, Nature's Terrorist Attack 
Pandemic Influenza,'' may be found in committee files.]
    [The prepared statements of Hon. Dan Burton, Hon. Jon C. 
Porter, and Hon. Diane E. Watson, and additional information 
submitted for the hearing record follows:]