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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

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

GINNY BROWN-WAITE, Florida

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

(III)

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, HoffmanLa 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

Page

IV

Letters, statements, etc., submitted for the record by—Continued

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

(1)

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.

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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

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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

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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

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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 vacVerDate 11-MAY-2000 10:18 Sep 06, 2005 Jkt 000000 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 D:\DOCS\22808.TXT HGOVREF1 PsN: HGOVREF1
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cine 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.

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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.

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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 antiviral 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 orderVerDate 11-MAY-2000 10:18 Sep 06, 2005 Jkt 000000 PO 00000 Frm 00089 Fmt 6633 Sfmt 6633 D:\DOCS\22808.TXT HGOVREF1 PsN: HGOVREF1
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ing 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 naVerDate 11-MAY-2000 10:18 Sep 06, 2005 Jkt 000000 PO 00000 Frm 00090 Fmt 6633 Sfmt 6633 D:\DOCS\22808.TXT HGOVREF1 PsN: HGOVREF1
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tional 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.

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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.

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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

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ordinated 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?

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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.

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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

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wide 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

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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-yearold 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.

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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.

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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. Intermuscular 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

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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 nonlicensed 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.

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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,

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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.

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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.

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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

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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.

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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.

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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 exVerDate 11-MAY-2000 10:18 Sep 06, 2005 Jkt 000000 PO 00000 Frm 00108 Fmt 6633 Sfmt 6633 D:\DOCS\22808.TXT HGOVREF1 PsN: HGOVREF1
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cluded 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.

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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

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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 Stateby-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

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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.

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tives 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.

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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

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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 researchbased 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

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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.

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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,

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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 necVerDate 11-MAY-2000 10:18 Sep 06, 2005 Jkt 000000 PO 00000 Frm 00174 Fmt 6633 Sfmt 6633 D:\DOCS\22808.TXT HGOVREF1 PsN: HGOVREF1
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essary 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

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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

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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

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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.

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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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