[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
THE NEXT FLU PANDEMIC: EVALUATING U.S. READINESS
=======================================================================
HEARING
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/
index.html
http://www.house.gov/reform
______
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
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
GINNY BROWN-WAITE, Florida C.A. DUTCH RUPPERSBERGER, Maryland
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
----------
Page
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
THE NEXT FLU PANDEMIC: EVALUATING U.S. READINESS
----------
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
Ruppersberger.
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
localities.
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
you.
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
follows:]
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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
hands.
[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.
STATEMENTS OF DR. JAMES W. LEDUC, 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
STATEMENT OF DR. JAMES W. LEDUC
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.
STATEMENT OF DR. ANTHONY S. 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
flu.
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.
STATEMENT OF DR. BRUCE 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
challenge.
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
considerations.
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
vaccines?
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
pandemic?
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
version.
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
plans.
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
responses.
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
thought.
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
pandemic?
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
right?
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
vaccine.
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
season.
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
case?
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
discussions.
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
needle.
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
million.
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
to.
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
it.
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
disorders.
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,
gentlemen?
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
cycle.
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
distribution.
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
facility.
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
much.
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.
STATEMENTS OF DR. MARCIA CROSSE, 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.
STATEMENT OF DR. MARCIA 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
country.
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
advance.
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.
Crosse.
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
preparedness.
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
done.
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.
STATEMENT OF DR. SHELLEY A. HEARNE
Dr. Hearne. Thank you. Mr. Chairman and members of the
committee, thanks for this opportunity to present our views on
preparedness.
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
committee.]
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
percent.
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.
STATEMENT OF DR. JOHN F. MILLIGAN
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
organizations.
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
flu.
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
Tamiflu.
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.
STATEMENT OF GEORGE B. 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
stockpile.
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
conditions.
Chairman Tom Davis. So the ingredients you can store
separately?
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
expire.
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
years?
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
State.
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
so.
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.
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
flu.
Dr. Iacuzio. Yes.
Chairman Tom Davis. Like for last year we could have used
this.
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
jurisdiction?
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
help.
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
supply?
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
it?
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
about.
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
things.
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
families.
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:]
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